DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Medicare & Medicaid Services 42 CFR Parts 410, 414, 415, 421, 423, 425, 486, and 495 [CMS-1590-FC]
RIN 0938-AR11 Medicare Program; Revisions to Payment Polic ies Under the Physician Fee Schedule, DME Face-to-Face Encounters, Elimination of the Requirement for Termination of Non-Random Prepayment Complex Medical Review and Other Revisions to Part B for CY 2013
AGENCY: Centers for Medicare & Medicaid Services (CMS), HHS.
ACTION: Final rule with comment period.
SUMMARY: This major final rule with comment peri od addresses changes to the physician fee schedule, payments for Part B drugs, and other Me dicare Part B payment policies to ensure that our payment systems are updated to reflect changes in medical practice and the relative value of services. It also implements pr ovisions of the Affordable Care Act by establishing a face-to-face encounter as a condition of payment for certain durable medical equipment (DME) items. In addition, it implements statutory changes regarding the termina tion of non-random prepayment review. This final rule with comment period also includes a discussion in the Supplementary Information regarding various prog rams . (See the Table of Contents for a listing of the specific issues addressed in this fina l rule with comment period.)
DATES : Effective date : The provisions of this final rule with comment period are effective on January 1, 2013 with the exception of provisi ons in §410.38 which are effective on July 1, 2013. The incorporation by reference of certain publica tions listed in the rule was approved by the Director of the Federal Register on May 16, 2012. Comment date : To be assured considerat ion, comments must be receive d at one of the addresses provided below, no later than 5 p.m. on [OFR—inser t date 60 days after the date of filing for2 public inspection at OFR.] (See the SUPPLEMEN TARY INFORMATION sec tion of this final rule with comment period for a list of the provisions open for comment.)
ADDRESSES: In commenting, please refer to file co de CMS-1590-FC. Because of staff and resource limitations, we ca nnot accept comments by facsimile (FAX) transmission. You may submit comments in one of four ways (please choose only one of the ways listed): 1. Electronically . You may submit electronic comments on this regulation to www.regulations.gov . Follow the instructions for "submitting a comment." 2. By regular mail . You may mail written comments to the following address ONLY: Centers for Medicare & Medicaid Services, Department of Health and Human Services, Attention: CMS-1590-FC, P.O. Box 8013, Baltimore, MD 21244-8013. Please allow sufficient time for mailed comments to be received before the close of the comment period. 3. By express or overnight mail . You may send written comments to the following address ONLY: Centers for Medicare & Medicaid Services, Department of Health and Human Services, Attention: CMS-1590-FC, Mail Stop C4-26-05, 7500 Security Boulevard, Baltimore, MD 21244-1850.3 4. By hand or courier . If you prefer, you may deli ver (by hand or courier) your written comments before the close of the comment period to either of the following addresses: a. For delivery in Washington, DC-- Centers for Medicare & Medicaid Services, Department of Health and Human Services, Room 445-G, Hubert H. Humphrey Building, 200 Independence Avenue, SW., Washington, DC 20201 (Because access to the interior of the Hube rt H. Humphrey Building is not readily available to persons without federal government identification, commenters are encouraged to leave their comments in the CMS drop slots located in the main lobby of the building. A stampin clock is available for persons wishing to reta in a proof of filing by st amping in and retaining an extra copy of the comments being filed.) b. For delivery in Baltimore, MD-- Centers for Medicare & Medicaid Services, Department of Health and Human Services, 7500 Security Boulevard, Baltimore, MD 21244-1850. If you intend to deliver your comments to the Baltimore address, please call telephone number (410) 786-7195 in advance to schedule your arrival with one of our staff members. Comments mailed to the addresses indicated as appropriate for hand or courier delivery may be delayed and received after the comment period.
FOR FURTHER INFORMATION CONTACT: Elliott Isaac, (410) 786-4735, for any physician payment issue not id entified below.4 Ryan Howe, (410) 786-3355, for issues re lated to practice expense methodology and direct practice expense inputs, te lehealth services, and issues re lated to primary care and care coordination. Sara Vitolo, (410) 786-5714, fo r issues related to potenti ally misvalued services, malpractice RVUs, molecular pathology, and pa yment for new preventive service HCPCS Gcodes, and the sustainable growth rate. Carol Schwartz (410) 786- 0576, for issues related to colonoscopy and preventive services. Ken Marsalek, (410) 786-4502, for issues re lated to the multiple procedure payment reduction and payment for the technical component of pathology services. Craig Dobyski, (410) 786-4584, for issues rela ted to geographic practice cost indices. Pam West, (410) 786-2302, for issues related to therapy services. Chava Sheffield, (410) 786-2298, for issues related to certified registered nurse anesthetists scope of benefit. Roberta Epps, (410)786-4503, for issues related to portable x-ray. Anne Tayloe-Hauswald, (410) 786-4546, for i ssues related to ambulance fee schedule and Part B drug payment. Amanda Burd, (410) 786-2074, for issues related to the DME provisions. Debbie Skinner, (410) 786-7480, for issues re lated to non-random prepayment complex medical review. Latesha Walker, (410) 786-1101, for issues related to ambulance coverage-physician certification statement. Alexandra Mugge, (410) 786-4457, for issu es related to physician compare. Christine Estella, (410) 786-0485 , for issues related to the physician quality reporting system, incentives for e-prescribing, and Medicare shared savings program.5 Pauline Lapin, (410) 786-6883, for issues re lated to the chirop ractic services demonstration budget neutrality issue. Gift Tee, (410) 786-9316, for issues related to the physician feedback reporting program and value-based payment modifier. Jamie Hermansen, (410) 786-2064, for issues rela ted to Medicare coverage for hepatitis B vaccine. Andrew Morgan, (410) 786-2543, for issues re lated to e-prescrib ing under Medicare
Part D.
SUPPLEMENTARY INFORMATION: Provisions open for comment : We will consider comments that are submitted as indicated above in the “Dates” a nd “Addresses” sections on the fo llowing subject areas discussed in this final rule with comment period:

● Interim final work, practice expense, a nd malpractice RVUs (including physician time, direct practice expense (PE) i nputs, and the equipment utiliza tion rate assumption) for new, revised, potentially misvalued, and certain ot her CY 2013 HCPCS codes as indicated in the sections that follow and listed in Addendum C to this final rule with comment period; and

● The appropriate direct PE inputs for es tablishing nonfacility PE RVUs for CPT code 63650 (Percutaneous implantation of neuros timulator electrode array, epidural). Inspection of Public Comments: All comments received before the close of the comment period are available for viewing by the public , including any persona lly identifiable or confidential business information that is included in a comment. We post all comments received before the close of the comment period on the fo llowing website as soon as possible after they have been received: www.regulations.gov . Follow the search instructions on that website to view public comments.6 Comments received timely will also be av ailable for public inspection as they are received, generally beginning approximately 3 w eeks after publication of a document, at the headquarters of the Centers for Medicare & Medicaid Services, 7500 Security Boulevard, Baltimore, Maryland 21244, Monday through Friday of each week from 8:30 a.m. to 4 p.m. To schedule an appointment to view pub lic comments, phone 1(800)743-3951.
Table of Contents To assist readers in referenc ing sections contained in this preamble, we are providing a table of contents. Some of the issues discussed in this preamble affect the payment policies, but do not require changes to the regulations in the C ode of Federal Regulations (CFR). Information on the regulations impact appears throughout th e preamble and, therefore, is not discussed exclusively in section VIII. of this final rule with comment period. I. Executive Summary and Background II. Provisions of the Final Rule with Comment Period A. Resource-Based Practice Expense (PE) Relative Value Units (RVUs) B. Potentially Misvalued Codes Under the Physician Fee Schedule C. Malpractice RVUs D. Geographic Practice Cost Indices (GPCIs) E. Medicare Telehealth Servi ces for the Physician Fee Schedule F. Extension of Payment for Technical Component of Certain Physician Pathology Services G. Therapy Services H. Primary Care and Care Coordination I. Payment for Molecular Pathology Services J. Payment for New Preventive Services HCPCS G Codes K. Certified Registered Nurse Anesthetists Scope of Benefit7 L. Ordering of Portable X-Ray Services M. Addressing Interim Final Relative Valu e Units (RVUs) from CY 2012 and Establish Interim Final Rule RVU's for CY 2013 N. Allowed Expenditures for Physicians' Services and the Sustainable Growth Rate III. Other Provisions of the Final Rule With Comment Period A. Ambulance Fee Schedule B. Part B Drug Payment: Aver age Sales Price (ASP) Issues C. Durable Medical Equipment (DME) F ace-to-Face Encounters and Written Orders Prior to Delivery D. Elimination of the Requirement fo r Termination of Non-random Prepayment Complex Medical Review E. Ambulance Coverage-Physic ian Certification Statement F. Physician Compare Website G. Physician Payment, Efficiency, and Quality Improvements – Physician Quality Reporting System H1. Electronic Prescribing (eRx) Incentive Program H2. The PQRS-Medicare EHR Incentive Pilot I. Medicare Shared Savings Program J. Discussion of Budget Neutrality for the Chiropractic Services Demonstration K. Physician Value-Based Payment Modifi er and the Physician Feedback Reporting Program L. Medicare Coverage of Hepatitis B Vaccine M. Updating Existing Standards for E-prescr ibing under Medicare Part D and Lifting the LTC Exemption IV. Additional Provisions8

A. Waiver of Deductible for Surgical Services Furnished on the Same Date as a Planned Screening Colorectal Cancer Test and Colo rectal Cancer Screening Test Definition— Technical Correction B. Physician Self-Referral Prohibition: Annual Update to the List of CPT/HCPCS Codes V. Collection of Information Requirements VI. Waiver of Proposed Rulemaking VII. Response to Comments VIII. Regulatory Impact Analysis Acronyms Because of the many organizations and terms to which we refer by acronym in this final rule with comment period, we are listing these acronyms and thei r corresponding terms in alphabetical order below: AHRQ [HHS] Agency for Healthcare Research and Quality AMA American Medical Association AMA RUC AMA [/Specialty Society] Relative [Value] Update Committee ARRA American Recovery and Re investment Act (Pub. L. 111-5) BBA Balanced Budget Act of 1997 (Pub. L. 105-33) BBRA [Medicare, Medicaid and State Child H ealth Insurance Program] Balanced Budget Refinement Act of 1999 (Pub. L. 106-113) BIPA [Medicare, Medicai d, and SCHIP] Benefits Impr ovement Protection Act of 2000 (Pub. L. 106-554) BLS Bureau of Labor Statistics BN Budget neutrality CAH Critical access hospital9

CBSA Core-Based Statistical Area CF Conversion factor CfC Conditions for Coverage CFR Code of Federal Regulations CNS Clinical nurse specialist CoPs Conditions of Participation CORF Comprehensive Outpat ient Rehabilitation Facility CPI Consumer Price Index CPT [Physicians] Current Procedural Termi nology (CPT codes, descriptions and other data only are copyright 2012 American Medi cal Association. All rights reserved.) CRNA Certified registered nurse anesthetist CY Calendar year DHS Designated health services DME Durable medical equipment DMEPOS Durable medical equipment, pr osthetics, orthotics, and supplies DOTPA Development of Outpatient Therapy Payment Alternatives DRA Deficit Reduction Act of 2005 (Pub. L. 109-171) E/M Evaluation and management EHR Electronic health record eRx Electronic prescribing FFS Fee-for-service
FR Federal Register GAF Geographic adjustment factor GAO [U.S.] Government Accountability Office GPRO Group Practice Reporting Option10 GPCI Geographic practice cost index HAC Hospital-acquired conditions HCPCS Healthcare Common Procedure Coding System HHA Home health agency HIPAA Health Insurance Portability and Accountability Act of 1996 (Pub. L. 104-191) HIT Health information technology HITECH Health Information Technology for Econom ic and Clinical Health Act (Title IV of Division B of the Recovery Act, together with Title XIII of Division A of the Recovery Act) HPSA Health Professional Shortage Area ICD International Classification of Diseases IMRT Intensity Modulated Radiation Therapy IOM Internet-only Manual IPCI Indirect practice cost index IPPS Inpatient prospective payment system IWPUT Intra-service work per unit of time MAC Medicare Administrative Contractor MCTRJCA Middle Class Tax Relief and J ob Creation Act of 2012 (Pub. L. 112-96) MEDCAC Medicare Evidence Development a nd Coverage Advisory Committee (formerly the Medicare Coverage Advisory Committee ) MedPAC Medicare Payment Advisory Commission MEI Medicare Economic Index MIEA-TRHCA Medicare Improvements and Extens ion Act of 2006 (that is, Division B of the Tax Relief and Health Care Act of 2006 (TRHCA) (Pub. L. 109-432) MIPPA Medicare Improvements for Patients and Providers Act of 2008 (Pub. L. 110-275)11 MMA Medicare Prescription Drug, Improve ment, and Modernization Act of 2003 (Pub. L. 108-173) MMEA Medicare and Medicaid Exte nders Act of 2010 (Pub. L. 111-309) MMSEA Medicare, Medicaid, and SCHIP Extension Act of 2007 (Pub. L. 110-173) MPPR Multiple procedure payment reduction MQSA Mammography Quality Standards Act of 1992 (Pub. L. 102-539) NP Nurse practitioner NPP Nonphysician practitioner OACT [CMS] Office of the Actuary OBRA Omnibus Budget Reconciliation Act (Pub. L. 101-239) OIG [HHS] Office of Inspector General PA Physician assistant PC Professional component PE Practice expense PE/HR Practice expense per hour PERC Practice Expense Review Committee PFS Physician Fee Schedule PGP [Medicare] Physician Group Practice PLI Professional liability insurance PPS Prospective payment system PQRS Physician Quality Reporting System PRA Paperwork Reduction Act PPTRA Physician Payment and Therapy Relief Act of 2010 (Pub. L. 111-286) PVBP Physician and Other Health Prof essional Value-Based Purchasing Workgroup RAC [Medicare] Recovery Audit Contractor12 RFA Regulatory Flexibility Act RIA Regulatory impact analysis RVU Relative value unit SBRT Stereotactic body radiation therapy SGR Sustainable growth rate TC Technical component TIN Tax identification number TPTCCA Temporary Payroll Tax Cut Continuation Act of 2011(Pub. L.112-78) TRHCA Tax Relief and Health Care Act of 2006 (Pub. L. 109-432) VBP Value-based purchasing Addenda Available Only Through th e Internet on the CMS Website In the past, the Addenda referred to thr oughout the preamble of our annual PFS proposed and final rules with comment period were included in the printed Federal Register . However, effective with the CY 2012 PFS final rule wi th comment period, the PFS Addenda no longer appear in the Federal Register . Instead these Addenda to the annual proposed and final rules with comment period will be available only th rough the Internet. Th e PFS Addenda along with other supporting documents and tables referenced in this final rule with comment period are available through the Intern et on the CMS website at www.cms.gov/PhysicianFeeSched/ . Click on the link on the left side of the screen titled, ‘‘PFS Federal Regulations Notices’’ for a chronological list of PFS Federal Register and other related documents. For the CY 2013 PFS final rule with comment period, refer to it em CMS–1590–FC. Readers who experience any problems accessing any of the Addenda or other docum ents referenced in this final rule with comment period and posted on the CMS Website iden tified above should cont act Elliott Isaac at (410) 786–4735.13
CPT (Current Procedural Terminology) Copyright Notice Throughout this final rule with comment pe riod, we use CPT codes and descriptions to refer to a variety of services. We note that CPT codes and descrip tions are copyright 2012 American Medical Association. All Rights Reserved. CPT is a registered trademark of the American Medical Association (AMA). Applic able Federal Acquisition Regulations (FAR) and Defense Federal Acquisition Regulations (DFAR) apply. I. Executive Summary and Background A. Executive Summary 1. Purpose This major final rule with comment period revises payment policies under the Medicare Physician Fee Schedule (PFS) and makes other policy changes related to Medicare Part B payment. These changes are applicable to serv ices furnished in CY 2013. It also implements provisions of the Affordable Care Act by estab lishing a face-to-face encounter as a condition of payment for certain durable medical equipmen t (DME) items. In addition, it implements statutory changes regarding the termina tion of non-random prepayment review. 2. Summary of the Major Provisions The Social Security Act (Act) requires us to establish payments under the PFS based on national uniform relative value units (RVUs) and the relative resources used in furnishing a service. The Act requires that national R VUs be established for physician work, practice expense (PE), and malpractice expense. In th is major final rule with comment period, we establish payment rates for CY 2013 for the PFS, payments for Part B drugs, and other Medicare Part B payment policies to ensure that our pa yment systems are updated to reflect changes in medical practice and in the relative value of se rvices. It also implem ents provisions of the Affordable Care Act by establishing a face-to -face encounter as a condition of payment for certain durable medical equipment (DME) items, and by removing certain regulations regarding14 the termination of non-random prepayment review. It also establishes new claims-based data reporting requirements for therapy services to implement a provision in the Middle Class Tax Relief and Jobs Creation Act (MCT RCA). In addition, this rule:

● Identifies Potentially Misv alued Codes to be Evaluated.

● Establishes Additional Multiple Procedure Payment Reductions (MPPR).

● Expands Medicare Telehealth Services.

● Implements Regulatory Changes Regard ing Payment for Technical Component of Certain Physician Pathology Servic es to Conform to Statute.

● Requires the inclusion of specific info rmation on claims for therapy services.

● Establishes New Transitional Care Management Services.

● Clarifies Services Included in the Certif ied Registered Nurse Anesthetists Scope of Benefit

● Modifies Ordering Requirement s for Portable X-ray Services.

● Updates the Ambulance Fee Schedule.

● Sets Part B Drug Payment Rates for 2013.

● Addresses Ambulance Coverage--P hysician Certification Statement.

● Updates policies regarding the-- ++ Physician Compare Website. ++ Physician Quality Reporting System. ++ Electronic Prescribing (eRx) Incentive Program. ++ Electronic Health Reco rd (EHR) Incentive Program. ++ Medicare Shared Savings Program.

● Discusses Budget Neutrality for the Chiropractic Demonstration.

● Addresses Implementation of the Physician Value-Based Payment Modifier and the Physician Feedback Reporting Program.15

● Establishes Medicare Cove rage of Hepatitis B Vaccine.

● Updates Existing Standards for e-prescrib ing under Medicare Part D and Lifting the LTC Exemption. 3. Summary of Costs and Benefits The statute requires that we establish by regulation each year payment amounts for all physicians’ service. These payment amounts are requi red to be adjusted to reflect the variations in the costs of providing services in different geographic areas. The statute also requires that annual adjustments to the RVUs not cause annual estimated expenditures to differ by more than $20 million from what they would have been had th e adjustments not been made. If adjustments to RVUs would cause expenditures to change by more than $20 million, we must make adjustments to preserve budget neutrality.

Several changes affect the specialty distribut ion of Medicare expenditures. This final rule with comment period reflect s the Administration’s priority to improve payment for primary care services. As described in Section II.N, in the absence of Congressional action, an overall reduction of 26.5 percent will be imposed in the c onversion factor used to calculate payment for physicians’ services on or after January 1, 2013 due to the Sustainable Growth Rate (SGR). To isolate the impact of changes that we are proposi ng in this final rule with comment period, we analyze and discuss the policies’ impact with a constant conversi on factor. In the absence of a change in the conversion factor, payments to pr imary care specialties will increase and payments to select other specialties will decrease due to several changes in how we calculate payments for
CY 2013. The largest payment increase for primary care specialties overall will result from a new payment for managing a beneficiary’s care when the beneficiary is discharged from an inpatient hospital, a SNF, an outpatient hospital obser vation, partial hospitaliz ation services, or a16 community mental health center. Payments to pr imary care specialties also will increase due to redistributions from changes in payments for serv ices furnished by other specialties. Because of the budget-neutral nature of this sy stem, decreases in payments for one service result in increases in payments in others. Payments to primary care specialties are also impacted by the completion of the 4-year transition to new PE RVUs using the new Physician Practice Informa tion Survey (PPIS) data that was adopted in the CY 2010 PFS final rule with comment period. The projected impacts of using the new PPIS data are generally consistent with the impacts discussed in the CY 2012 final rule with comment period (76 FR 72452). Several types of providers are projected to see decreases in Medicare PFS payments, mainly as a result of the potentially misvalued c odes initiative. We have received numerous new codes with new values and revised codes with new values for CY 2013 as a result of our ongoing misvalued codes initiative, an effort to improve payment accuracy. Many of the new and revised codes that we valued on an interim basis for CY 2013 originated with the potentially misvalued codes initiative. Reductions for pathology, neur ology, and independent la boratories are a result of the misvalued code initiativ e. In the case of independent laboratories, we note that independent laboratories receive the majority of the Medicare revenue from the Clinical Lab Fee Schedule, which is unaffected by the misvalued c ode initiative. Radiation therapy centers will see an overall decrease of 9 percent primarily as a result of the PPIS tr ansition discussed above and a change in the interest rate assumption used to calculate PE. Radi ation oncology sees a 7 percent decrease for the same reasons as radiation therapy centers.

B. Background We note that throughout this final rule w ith comment period, unless otherwise noted, the term “practitioner” is used to describe both physicians and nonphysician practitioners (such as17 physician assistants, nurse practi tioners, clinical nurse specialis ts, certified nurse-midwives, psychologists, or clinical social workers) w ho are permitted to bill Medicare under the PFS for their services. Since January 1, 1992, Medicare has paid for physicians’ services under section 1848 of the Act, “Payment for Physicians' Services .” The Act requires that CMS make payments under the PFS using national uniform relative va lue units (RVUs) based on the relative resources used in furnishing a service. Section 1848(c) of the Act requires that national RVUs be established for physician work, PE, and malpracti ce expense. Before the establishment of the resource-based relative value system, Medicare payment for physicians’ services was based on reasonable charges. 1. Development of the Relative Value System a. Work RVUs The concepts and methodology underlying the PFS were enacted as part of the Omnibus Budget Reconciliation Act (OBRA) of 1989 (Pub. L. 101-239), and OBRA 1990, (Pub. L. 101-508). The final rule published on November 25, 1991 (56 FR 59502) set forth the fee schedule for payment for physicians’ services beginning January 1, 1992. The physician work RVUs established for th e implementation of the fee schedule in January 1992 were developed with extensive in put from the physician community. A research team at the Harvard School of Public Health developed the original physician work RVUs for most codes in a cooperative agreement with th e Department of Health and Human Services (HHS). In constructing the code-specific vi gnettes for the original physician work RVUs, Harvard worked with panels of experts, both inside and outside the federal government, and obtained input from numerous physician specialty groups. Section 1848(b)(2)(B) of the Act specifies that the RVUs for anesthesia services are based on RVUs from a uniform relative value gu ide, with appropriate adjustment of the conversion factor (CF), in a manner to assure th at fee schedule amounts for anesthesia services18

are consistent with those for othe r services of comparable value. We established a separate CF for anesthesia services, and we continue to utili ze time units as a factor in determining payment for these services. As a result, there is a sepa rate payment methodology for anesthesia services. We establish physician work RVUs for ne w and revised codes based, in part, on our review of recommendations receiv ed from the American Medical Association/Specialty Society Relative Value Update Committee (AMA RUC). b. Practice Expense Relativ e Value Units (PE RVUs) Initially, only the physician work RVUs were res ource-based, and the PE and malpractice RVUs were based on average allowable charges. Sect ion 121 of the Social S ecurity Act Amendments of 1994 (Pub. L. 103-432), and Section 4505(a) of the Balanced Budget Act of 1997 (BBA) (Pub. L. 105-33) amended section 1848(c)(2)(C)(ii) of the Act and required us to develop resource-based PE RVUs for each physicians’ servi ce. We were to consider general categories of expenses (such as office rent and wages of personnel, but excluding malpractice expenses) comprising PEs. We established the resource-based PE RVUs for each physicians’ service in a final rule, published November 2, 1998 (63 FR 58814), effective for services furnished in 1999. Separate PE RVUs are established for procedures that can be furnished in both a nonfacility setting, such as a physician's office, and a facility setting, su ch as a hospital outpatien t department (HOPD). The difference between the facility and nonfacility R VUs reflects the fact that a facility typically receives separate payment from Medicare for its costs of furnishing th e service, apart from payment under the PFS. The nonfacility RVUs refl ect all of the direct and indirect PEs of furnishing a particular service. Based on the BBA requirement to transiti on to a resource-based system for PE over a 4-year peri od, resource-based PE RVUs did not become fully effective until
2002.19 This resource-based system was based on tw o significant sources of actual PE data. Panels of physicians, practice administrators , and nonphysician health professionals (for example, registered nurses (RNs)), who were nominated by physician specialty societies and other groups identified the direct inputs required for each physicians’ service. (We have since refined and revised these input s based on recommendations from the AMA RUC.) Aggregate specialty-specific information on hours work ed and PEs was obtained from the AMA’s Socioeconomic Monitoring System (SMS). Section 212 of the Balanced Budget Refine ment Act of 1999 (BBRA) (Pub. L. 106-113) directed us to establish a process under wh ich we accept and use, to the maximum extent practicable and consistent with sound data practices, data collected or developed by entities and organizations to supplement the data we normally collect in determining the PE component. On May 3, 2000, we published the interim final rule ( 65 FR 25664) that set fort h the criteria for the submission of these supplemental PE survey data . The criteria were modified in response to comments received, and published in the Federal Register (65 FR 65376) as part of a November 1, 2000 final rule. The PFS fina l rules published in 2001 and 2003, respectively, (66 FR 55246 and 68 FR 63196) extended the period during which we would accept these supplemental data through March 1, 2005. In the CY 2007 PFS final rule with comme nt period (71 FR 69624) , we revised the methodology for calculating direct PE RVUs fr om the top-down to the bottom-up methodology beginning in CY 2007. We adopted a 4-year trans ition to the new PE RVUs. This transition was completed in CY 2010. Direct PE RVUs were calculated for CY 2013 using this methodology, unless otherwise noted. In the CY 2010 PFS final rule with comment period, we updated the practice expense per hour (PE/HR) data that are used in the calcu lation of PE RVUs for most specialties (74 FR 61749). For this update, we used the P hysician Practice Information Survey (PPIS)20 conducted by the AMA. The PPIS is a multispecialty, nationally representative, PE survey of both physicians and nonphysician practitioners (N PPs) using a survey instrument and methods highly consistent with those used prior to CY 2010. We note that in CY 2010, for oncology, clinical laboratories, and indepe ndent diagnostic testing facilitie s (IDTFs), we continued to use the supplemental survey data to determin e PE/HR values (74 FR 61752). Beginning in CY 2010, we provided for a 4-year transition fo r the new PE RVUs using the updated PE/HR data. In CY 2013, the final year of the transi tion, PE RVUs are calculated based on the new data. c. Resource-Based Malpractice RVUs Section 4505(f) of the BBA amended section 1848(c) of the Act to require that we implement resource-based malpractice RVUs fo r services furnished on or after CY 2000. The resource-based malpractice RVUs were implemen ted in the PFS final rule with comment period published November 2, 1999 (64 FR 59380). The malpractice RVUs were based on malpractice insurance premium data colle cted from commercial and physician-owned insurers. d. Refinements to the RVUs Section 1848(c)(2)(B)(i) of th e Act requires that we review all RVUs no less often than every 5 years. Prior to CY 2013, we conducted se parate periodic reviews of work RVUs and PE RVUs. The First Five-Year Review of Work RVUs was published on November 22, 1996 (61 FR 59489) and was effective in 1997. The Second Five-Year Review of Work RVUs was published in the CY 2002 PFS final rule with co mment period (66 FR 55246) and was effective in 2002. The Third Five-Year Review of Work RVUs was published in the CY 2007 PFS final rule with comment period (71 FR 69624) and was effective on January 1, 2007. The Fourth Five-Year Review of Work RVUs was publishe d in the CY 2012 PFS final rule with comment period (76 FR 73026).21 Initially refinements to the direct PE inputs relied on i nput from the AMA RUCestablished the Practice Expense Advisory Co mmittee (PEAC). Through March 2004, the PEAC provided recommendations to CMS for more th an 7,600 codes (all but a few hundred of the codes included in the AMAs Current Procedural Terminology (CPT) codes). As part of the CY 2007 PFS final rule with comment period (71 FR 69624), we implemented a new bottom-up methodology for determining resource-based PE RVUs and transitioned the new methodology over a 4-year period. A comprehensive review of PE was undertaken prior to the 4-year transition period for the new PE methodology fr om the top-down to the bottom-up methodology, and this transition was complete d in CY 2010. In CY 2010, we also incorporated the new PPIS data to update the specialty-specific PE/HR data used to develop PE RVUs, adopting a 4-year transition to PE RVUs deve loped using the PPIS data. In the CY 2012 PFS final rule with comme nt period (76 FR 73057), we finalized a proposal to consolidate reviews of work and PE RVUs under se ction 1848(c)(2)(B ) of the Act and reviews of potentially misv alued codes under section 1848(c )(2)(K) of the Act into one annual process. In the CY 2005 PFS final rule with comment period (69 FR 66236), we implemented the first Five-Year Review of the malpractice RVUs (69 FR 66263). Minor modifications to the methodology were addressed in the CY 2006 PFS final rule with comment period (70 FR 70153). The second Five-Year Review and update of resource-based malpractice RVUs was published in the CY 2010 PFS final rule with comment period (74 FR 61758) and was effective in CY 2010. In addition to the Five-Year Reviews, beginning for CY 2009, CMS and the AMA RUC have identified and reviewed a number of poten tially misvalued codes on an annual basis based on various identification screens. This annual review of work and PE RVUs for potentially misvalued codes was supplemented by the amendments to Section 1848 of the Act, as enacted22 by section 3134 of the Affordable Care Act, whic h requires the agency to periodically identify, review and adjust values for potentially misv alued codes with an emphasis on the following categories: (1) codes and families of codes for wh ich there has been the fastest growth; (2) codes or families of codes that have experienced substantial changes in PEs; (3) codes that are recently established for new technologies or services; (4) multiple codes that are frequently billed in conjunction with furnishing a single service; (5) codes with low relative values, particularly those that are often billed multiple times for a single treatment; (6) codes which have not been subject to review since the implementation of th e fee schedule (the so-c alled ‘Harvard valued codes’); and (7) other codes determined to be appropriate by the Secretary. e. Application of Budget Neutra lity to Adjustments of RVUs Budget neutrality (BN) typical ly requires that expenditures not increase or decrease as a result of changes or revisions to policy. Ho wever, section 1848(c)(2 )(B)(ii)(II) of the Act requires adjustment only if the change in expend itures resulting from the annual revisions to the PFS exceeds a threshold amount. Specifically, adju stments in RVUs for a year may not cause total PFS payments to differ by more than $20 million from what they would have been if the adjustments were not made. In accordance with section 1848(c)(2)(B)(ii)(II) of the Act, if revisions to the RVUs would cause expenditures to change by more than $20 million, we make adjustments to ensure that expenditures do not increase or decrease by more than $20 million. 2. Components of the Fee Schedule Payment Amounts To calculate the payment for each physicia ns’ service, the components of the fee schedule (work, PE, and malpractice RVUs) are adjusted by geographic practice cost indices (GPCIs). The GPCIs reflect the relative costs of physician work, PE , and malpractice in an area compared to the national average costs for each component. RVUs are converted to dollar amounts th rough the application of a CF, which is calculated by CMS’ Office of the Actuary (OACT).23 The formula for calculating the Medicare fee schedule payment amount for a given service and fee schedule area can be expressed as: Payment = [(RVU work x GPCI work) + (R VU PE x GPCI PE) + (RVU malpractice x GPCI malpractice)] x CF. 3. Most Recent Changes to the Fee Schedule The CY 2012 PFS final rule with comment period (76 FR 73026) implemented changes to the PFS and other Medicare Part B payment polic ies. It also finalized many of the CY 2011 interim RVUs and implemented interim RVUs for new and revised codes for CY 2012 to ensure that our payment systems are upda ted to reflect changes in medi cal practice and the relative values of services. In the CY 2012 PFS fina l rule with comment period, we announced the following for CY 2012: the total PFS update of -27.4 percent; the init ial estimate for the sustainable growth rate (SGR) of -16.9 per cent; and the conversion factor (CF) of $24.6712. These figures were calculated based on the st atutory provisions in e ffect on November 1, 2011, when the CY 2012 PFS final rule with comment period was issued. A correction notice was issued (77 FR 227) to correct several technical and typographical errors that occurred in the CY 2012 PFS final rule with comment period. On December 23, 2011, the Temporary Payr oll Tax Cut Continuation Act of 2011 (TPTCCA) (Pub. L. 112-78) was signed into law. Section 301 of the TPTCCA specified a zero percent update to the PFS from January 1, 2012 through February 29, 2012. As a result, the CY 2012 PFS conversion factor wa s revised to $34.0376 for claims with dates of service on or after January 1, 2012 through February 29, 2012. In addition, the TPTC CA extended several provisions affecting Medicare se rvices furnished on or after January 1, 2012 through February 29, 2012, including:

● Section 303 - the 1.0 floor on the physicia n work geographic practice cost index;

● Section 304 - the exceptions pr ocess for outpatient therapy caps;24

● Section 305 - the payment to independent laboratories for the technical component (TC) of physician pathology services furn ished to certain hospital patients, and

● Section 307 - the 5 percen t increase in payments for mental health services. On February 22, 2012, the Middle Class Tax Relief and Job Creation Act of 2012 (Pub. L. 112-96) (MCTRJCA) was signed into law. Section 3003 of the MCTRJCA extended the zero percent PFS update to the remai nder of CY 2012. As a result of the MCTRJCA, the CY 2012 PFS CF was maintained as $34.0376 for claims with dates of service on or after March 1, 2012 through December 31, 2012. In addition:

● Section 3004 of MCTRJCA extended the 1.0 floor on the physician work geographic practice cost index through December 31, 2012;

● Section 3006 continued payment to indepe ndent laboratories fo r the TC of physician pathology services furnished to certain hospital patients through June 30, 2012; and

● Section 3005 extended the exceptions process for outpati ent therapy caps through CY 2012 and made several other changes re lated to therapy claims and caps. II. Provisions of the Final Rule for the Physician Fee Schedule A. Resource-Based Practice Expense (PE) Relative Value Units (RVUs) 1. Overview Practice expense (PE) is the portion of the resources used in fu rnishing the service that reflects the general cate gories of physician and practiti oner expenses, such as office rent and personnel wages but excluding malpr actice expenses, as specified in section 1848(c)(1)(B) of the Act. Section 121 of the Social Security Amendments of 1994 (Pub. L. 103-432), enacted on October 31, 1994, amended section 1848(c)(2)(C)(ii) of the Act to require us to develop a me thodology for a resource-based system for determining PE RVUs for each physician’s serv ice. We develop PE RVUs by looking at the direct and indirect physician practice re sources involved in furnishing each service.25 Direct expense categories include clinical labor, medical supplies, and medical equipment. Indirect expenses include admi nistrative labor, office e xpense, and all other expenses. The sections that follow provi de more detailed information about the methodology for translating the resources involved in furnishing each service into service-specific PE RVUs. In addition, we note that sec tion 1848(c)(2)(B)( ii)(II) of the Act provides that adjustments in RVUs for a year may not cause total PFS payments to differ by more than $20 million from what th ey would have otherwise been if the adjustments were not made. Therefore, if revisions to the RVUs cause expenditures to change by more than $20 million, we make adjustments to ensure that expenditures do not increase or decrease by more than $20 m illion. We refer readers to the CY 2010 PFS final rule with comment period (74 FR 61743 through 61748) for a more detailed explanation of the PE methodology. 2. Practice Expense Methodology a. Direct Practice Expense We use a “bottom-up” approach to determine the direct PE by adding the costs of the resources (that is, the clinical st aff, equipment, and supplies) t ypically involved with furnishing each service. The costs of th e resources are calculated using the refined direct PE inputs assigned to each CPT code in our PE data base, which are based on our review of recommendations received from the AMA RUC. For a detailed explanation of the bottom-up direct PE methodology, including ex amples, we refer readers to th e Five-Year Review of Work Relative Value Units Under the PFS and Pr oposed Changes to the Practice Expense Methodology proposed notice (71 FR 37242) and the CY 2007 PFS final rule with comment period (71 FR 69629). b. Indirect Practice Ex pense per Hour Data26 We use survey data on indirect PEs incurre d per hour worked in developing the indirect portion of the PE RVUs. Prior to CY 2010, we primarily used the practice expense per hour (PE/HR) by specialty that was obtained from the AMA’s Socioeconomic Monitoring Surveys (SMS). The AMA administered a new survey in CY 2007 and CY 2008, the Physician Practice Expense Information Survey (PPIS), which was expanded (relative to the SMS) to include nonphysician practitioners (N PPs) paid under the PFS. The PPIS is a multispecialty, nationally repres entative, PE survey of both physicians and NPPs using a consistent survey instrument and methods highly cons istent with those used for the SMS and the supplemental surveys. The PPIS gathered information from 3,656 respondents across 51 physician specialty and healthcare prof essional groups. We believe the PPIS is the most comprehensive source of PE survey informati on available to date. Therefore, we used the PPIS data to update the PE/HR data fo r the CY 2010 PFS for almost all of the Medicare-recognized specia lties that participat ed in the survey. When we began using the PPIS data begi nning in CY 2010, we did not change the PE RVU methodology itself or the manner in which th e PE/HR data are used in that methodology. We only updated the PE/HR data based on the new su rvey. Furthermore, as we explained in the CY 2010 PFS final rule with comment period (74 FR 61751), because of the magnitude of payment reductions for some specialties resulting from the use of the PPIS data, we finalized a 4-year transition (75 percent ol d/25 percent new for CY 2010, 50 pe rcent old /50 percent new for CY 2011, 25 percent old /75 percent new for CY 2012, and 100 percent new for CY 2013) from the previous PE RVUs to the PE RVUs developed using the new PPIS data. Section 1848(c)(2)(H)(i) of the Act re quires us to use the medical oncology supplemental survey data submitted in 2003 fo r oncology drug administration services. Therefore, the PE/HR for medical oncology, he matology, and hematology/oncology reflects the continued use of these supplemental survey data.27 We do not use the PPIS data for reproduc tive endocrinology and spine surgery since these specialties currently are not separately recognized by Medicare, nor do we have a method to blend these data with Medica re-recognized specialty data. Si milarly, we do not use the PPIS data for sleep medicine since there is not a full year of Medicare ut ilization data for that specialty given when the specialty code was created. Supplemental survey data on independent labs, from the College of American Pathologists, were implemented for payments in CY 2005. Supplemental survey data from the National Coalition of Quality Di agnostic Imaging Services (NC QDIS), representing independent diagnostic testing facilities (ID TFs), were blended with supplem entary survey data from the American College of Radiology (ACR) and impl emented for payments in CY 2007. Neither IDTFs nor independent labs partic ipated in the PPIS. Therefore, we continue to use the PE/HR that was developed from their supplemental survey data. Consistent with our past practice, the previous indire ct PE/HR values from the supplemental surveys for medical oncology, indepe ndent laboratories, and IDTFs were updated to CY 2006 using the MEI to put them on a co mparable basis with the PPIS data. Previously, we have established PE/HR valu es for various specialties without SMS or supplemental survey data by crosswalking them to other similar specialties to estimate a proxy PE/HR. For specialties that were part of the PPIS for which we previously used a crosswalked PE/HR, we instead use the PPIS-based PE/HR. We continue previous crosswalks for specialties that did not participate in th e PPIS. However, beginning in CY 2010 we changed the PE/HR crosswalk for portable x-ray suppliers from ra diology to IDTF, a more appropriate crosswalk because these specialties are more sim ilar to each other for physician time. For registered dietician services, the resour ce-based PE RVUs have been calculated in accordance with the final policy th at crosswalks the specialty to the “All Physicians” PE/HR28 data, as adopted in the CY 2010 PFS final rule with comment period (74 FR 61752) and discussed in more detail in th e CY 2011 PFS final rule with comment period (75 FR 73183). There were five specialties whose utiliz ation data were newly incorporated into ratesetting for CY 2012. In accordance with the fi nal policies adopted in the CY 2012 final rule with comment period (76 FR 73036), we use pr oxy PE/HR values for these specialties by crosswalking values from other, similar specia lties as follows: Speech Language Pathology from Physical Therapy; Hospice and Palliative Care from All Physicians; Geriatric Psychiatry from Psychiatry; Intensive Cardiac Rehabilitation from Cardiology, and Certifie d Nurse Midwife from Obstetrics/gynecology. For CY 2013, there are two speci alties whose utilization data will be newly incorporated into ratesetting. We proposed to use proxy PE/H R values for these specialties by crosswalking values from other specialties th at furnish similar services as follows: Cardiac Electrophysiology from Cardiology; and Sports Medicine from Family Practice. These proposed changes are reflected in the “PE HR” file available on the CMS website under the supporting data files for the CY 2013 PFS final rule with comment period at www.cms.gov/PhysicianFeeSched/

. We did not receive any comments regard ing our proposal to use these proxy PE/HR values for these specialties, and we continue to believe that the values crosswalked from other specialties that furnish similar services are a ppropriate. Therefore, we are finalizing our CY 2013 proposals to update the PE /HR data as reflected in the "PE HR" file available on the CMS website under the supporting data files fo r the CY 2013 PFS final rule with comment period at http://www.cms.gov/PhysicianFeeSched/

. As provided in the CY 2010 PFS final ru le with comment period (74 FR 61751), CY 2013 is the final year of the 4-year transition to the PE RVUs calculated using the PPIS data. Therefore, the CY 2013 PE RVUs are developed ba sed entirely on the PPIS data, except as noted in this section.29

c. Allocation of PE to Services To establish PE RVUs for specific services , it is necessary to establish the direct and indirect PE associated with each service. (1) Direct Costs The relative relationship between the direct cost portions of the PE RVUs for any two services is determined by the relative rela tionship between the sum of the direct cost resources (that is, the clinical staff, equipment, and supplie s) typically involved with furnishing the services. The costs of these resources are calculated from the refined direct PE inputs in our PE database. For exam ple, if one service has a direct cost sum of $400 from our PE database and another service has a direct cost sum of $200, the direct portion of the PE RVUs of the first service would be twice as much as the direct portion of the PE RVUs for the second service. (2) Indirect Costs Section II.A.2.b. of this final rule with comment period describes the current data sources for specialty-specific indirect costs us ed in our PE calculations. We allocated the indirect costs to the c ode level on the basis of the direct costs specifically associated with a code and the greater of either the clinical labor costs or the phys ician work RVUs. We also incorporated the survey data describe d earlier in the PE/HR di scussion. The general approach to developing the indi rect portion of the PE RVUs is described as follows:

• For a given service, we use the dir ect portion of the PE RVUs calculated as previously described and the average percentage that direct costs represent of total costs (based on survey data) across the specialties that furnish the service to determine an initial indirect allocator. Fo r example, if the direct portion of the PE RVUs for a given service was 2.00 and direct costs, on average, represented 25 percent of total costs for the30 specialties that furnished the service, the initial indirect alloca tor would be 6.00 since 2.00 is 25 percent of 8.00 and 6.00 is 75 percent of 8.00.

• Next, we add the greater of the work RVUs or clinical labor portion of the direct portion of the PE RVUs to this initial indirect allocator. In our example, if this service had work RVUs of 4.00 and the clinical labor portion of the direct PE RVUs was 1.50, we would add 6.00 plus 4.00 (since the 4.0 0 work RVUs are greater than the 1.50 clinical labor portion) to get an indirect allocator of 10.00. In the absence of any further use of the survey data, the re lative relationship between the in direct cost portions of the PE RVUs for any two services would be dete rmined by the relative relationship between these indirect cost allocators. For example, if one service had an indi rect cost allocator of 10.00 and another service had an indirect cost allocator of 5.00, the indirect portion of the PE RVUs of the first service would be twice as great as the indire ct portion of the PE RVUs for the second service.

• Next, we next incorporate the specialty -specific indirect PE/HR data into the calculation. As a relatively ex treme example for the sake of simplicity, assume in our previous example that, based on the survey data, the average indirect cost of the specialties furnishing the first service with an allocator of 10.00 was half of the average indirect cost of the specialties furnishing the second service w ith an indirect allocator of 5.00. In this case, the indirect portion of the PE RVUs of th e first service would be equal to that of the second service. d. Facility and Nonfacility Costs For procedures that can be furnished in a physician’s office, as well as in a hospital or facility setting, we establish two PE RVUs: facility and nonfacility. The methodology for calculating PE RVUs is the sa me for both the facility and nonfacility RVUs, but is applied independently to yield two separate PE RVUs. Because Medicare31 makes a separate payment to the facility for its costs of furnishing a service, the facility PE RVUs are generally lower th an the nonfacility PE RVUs. e. Services with Technical Components (TCs) and Professional Components (PCs) Diagnostic services are generally compri sed of two components: a professional component (PC) and a technical component (TC), each of which may be furnished independently or by different pr oviders, or they may be furnis hed together as a “global” service. When services have PC and TC co mponents that can be billed separately, the payment for the global component equals the sum of the payment for the TC and PC. This is a result of using a weighted average of the ratio of indirect to direct costs across all the specialties that furnish the global com ponents, TCs, and PCs; that is, we apply the same weighted average indirect percentage f actor to allocate indirect expenses to the global components, PCs, and TCs for a service. (The direct PE RVUs for the TC and PC sum to the global under the bottom-up methodology.) f. PE RVU Methodology For a more detailed description of th e PE RVU methodology, we refer readers to the CY 2010 PFS final rule with comment period (74 FR 61745 through 61746). (1) Setup File First, we create a setup file for the PE methodology. The setu p file contains the direct cost inputs, the utilization for each procedure code at the specialty and facility/nonfacility place of service level, and the specia lty-specific PE/HR data from the
surveys. (2) Calculate the Direct Cost PE RVUs Sum the costs of each direct input. Step 1 : Sum the direct costs of th e inputs for each service. Apply a scaling adjustment to the direct inputs.32
Step 2 : Calculate the current aggregate pool of direct PE costs. This is the product of the current aggregat e PE (aggregate direct and indirect) RVUs, the CF, and the average direct PE percentage from the survey data. Step 3 : Calculate the aggregate pool of dir ect costs. This is the sum of the product of the direct costs for each service from Step 1 and the utilization data for that service. Step 4: Using the results of Step 2 and St ep 3 calculate a direct PE scaling adjustment so that the aggregate direct co st pool does not exceed the current aggregate direct cost pool and apply it to the dir ect costs from Step 1 for each service. Step 5 : Convert the results of Step 4 to an RVU scale for each service. To do this, divide the results of Step 4 by the CF. No te that the actual value of the CF used in this calculation does not influence the final di rect cost PE RVUs, as long as the same CF is used in Step 2 and Step 5. Different CFs will result in different direct PE scaling factors, but this has no effect on the final di rect cost PE RVUs since changes in the CFs and changes in the associated direct s caling factors offset one another. (3) Create the Indirect Cost PE RVUs Create indirect allocators. Step 6 : Based on the survey data, calculate di rect and indirect PE percentages for each physician specialty. Step 7 : Calculate direct and indirect PE pe rcentages at the service level by taking a weighted average of the results of Step 6 fo r the specialties that furnish the service. Note that for services with TCs and PCs, th e direct and indirect percentages for a given service do not vary by the PC, TC, and global components.33
Step 8 : Calculate the service level alloca tors for the indirect PEs based on the percentages calculated in Step 7. The indirect PEs are allocated based on the three components: the direct PE RVUs, the c linical PE RVUs, and the work RVUs. For most services the indirect allocator is: indirect percentage * (direct PE RVUs/direct percentage) + work RVUs. There are two situations wher e this formula is modified:

• If the service is a global service (that is, a service with global, professional, and technical components), then the indirect a llocator is: indirect percentage (direct PE RVUs/direct percentage) + c linical PE RVUs + work RVUs.

• If the clinical labor PE RVUs exceed the work RVUs (and the service is not a global service), then the i ndirect allocator is: indi rect percentage (direct PE RVUs/direct percentage) + clinical PE RVUs. (Note : For global services, the indirect allocator is based on both the work RVUs and the clinical labor PE RVUs . We do this to recognize that, fo r the PC service, indirect PEs will be allocated using the work RVUs, and for the TC service, indirect PEs will be allocated using the direct PE RVUs and the clin ical labor PE RVUs. This also allows the global component RVUs to equal the sum of the PC and TC RVUs.) For presentation purposes in the examples in Table 1, th e formulas were divided into two parts for each service.

• The first part does not vary by service and is the indirect percentage (direct PE RVUs /direct percentage).

• The second part is either the work RVUs, clinical PE RVUs, or both depending on whether the service is a global service a nd whether the clinical PE RVUs exceed the work RVUs (as described ear lier in this step). Apply a scaling adjustment to the indirect allocators.34
Step 9 : Calculate the current aggregate pool of indirect PE RVUs by multiplying the current aggregate pool of PE RVUs by the average indire ct PE percentage from the survey data. Step 10 : Calculate an aggregate pool of indi rect PE RVUs for all PFS services by adding the product of the indirect PE allo cators for a service from Step 8 and the utilization data for that service. Step 11 : Using the results of Step 9 and Step 10, calculate an indirect PE adjustment so that the aggregate indir ect allocation does not exceed the available aggregate indirect PE RVUs and apply it to indirect allocators calculated in Step 8. Calculate the indirect practice cost index. Step 12 : Using the results of Step 11, calculate aggr egate pools of specialty-specific adjust ed indirect PE allocators for a ll PFS services for a specialty by adding the product of the adjusted indirect PE allocator for each service and the utilization data for that service. Step 13 : Using the specialty-specific indirect PE/HR data, calculate specialty-specific aggregate pools of indirect PE for all PFS services for that specialty by adding the product of the indirect PE/HR fo r the specialty, the physician time for the service, and the specialty's utilization for the service across all services furnished by the specialty. Step 14 : Using the results of Step 12 and St ep 13, calculate the specialty-specific indirect PE scaling factors. Step 15 : Using the results of Step 14, calculate an indirect practice cost index at the specialty level by dividing each specialty -specific indirect scaling factor by the average indirect scaling fact or for the entire PFS.35
Step 16 : Calculate the indirect practice cost index at the service level to ensure the capture of all indirect cost s. Calculate a weighted aver age of the practice cost index values for the specialties that furnish the servi ce. (Note: For services with TCs and PCs, we calculate the indirect practi ce cost index across the global components, PCs, and TCs. Under this method, the indirect practice cost index for a given service (for example, echocardiogram) does not vary by the PC, TC, and global component.) Step 17 : Apply the service level indirect prac tice cost index calc ulated in Step 16 to the service level adjusted indirect allocators calculated in Step 11 to get the indirect PE
RVUs. (4) Calculate the Final PE RVUs Step 18 : Add the direct PE RVUs from Step 6 to the indirect PE RVUs from Step 17 and apply the final PE budge t neutrality (BN) adjustment. The final PE BN adjustment is calculate d by comparing the results of Step 18 to the current pool of PE RVUs. This final BN adjustment is required in order to redistribute RVUs from step 18 to all PE RVUs in the PFS a nd because certain specialties are excluded from the PE RVU calculation for ratesetting purposes, but all specialties are included for purposes of calculating the final BN adjustment. (See “Specialties excluded from ratesetting calculation” later in this section.)36 (5) Setup File Information

• Specialties excluded from ratesetting calculation : For the purposes of calculating the PE RVUs, we exclude certain specialties, such as certain nonphysician practitioners paid at a pe rcentage of the PFS and low- volume specialties, from the calculation. These specialties are include d for the purposes of calculating the BN adjustment. They are displayed in Table 1. TABLE 1: Specialties Excluded From Ratesetting Calculation Specialty Code Specialty Description 49 Ambulatory surgical center 50 Nurse practitioner 51 Medical supply company with certified orthotist 52 Medical supply company with certified prosthetist 53 Medical supply company with certified prosthetist-orthotist 54 Medical supply company not included in 51, 52, or 53. 55 Individual certified orthotist 56 Individual certified prosthestist 57 Individual certified prosthetist-orthotist 58 Individuals not included in 55, 56, or 57 59 Ambulance service supplier, e.g., private ambulance companies, funeral homes, etc. 60 Public health or welfare agencies 61 Voluntary health or charitable agencies 73 Mass immunization roster biller 74 Radiation therapy centers 87 All other suppliers (e.g., drug and department stores) 88 Unknown supplier/provider specialty 89 Certified clinical nurse specialist 95 Competitive Acquisition Program (CAP) Vendor 96 Optician 97 Physician assistant A0 Hospital A1 SNF A2 Intermediate care nursing facility A3 Nursing facility, other A4 HHA A5 Pharmacy A6 Medical supply company with respiratory therapist A7 Department store 1 Supplier of oxygen and/or oxygen related equipment 2 Pedorthic personnel 3 Medical supply company with pedorthic personnel In the CY 2013 PFS proposed rule, we proposed to calculate the specialty mix for low volume services (fewer than 100 billed services in the previous year) using the same37 methodology we used for non-low volume services. We currently use the survey data from the dominant specialty for these low vol ume services. We proposed to calculate a specialty mix for these services rather than use the dominant specialty in order to smooth year-to-year fluctuations in PE RVUs due to changes in the dominant specialty. However, the PE RVUs for the affected HC PCS codes were inadvertently displayed in Addendum B for the CY 2013 PFS proposed ru le using our previously established methodology of using the dominant specialty fo r these services. While we received comments on our proposal, including some s uggesting alternative methods for handling low volume services, we do not believe that it would be appropriate to make changes to the current methodology since the correct imp act of the proposed calculation was not reflected in the displayed PE RVUs. We appreciate the commenters’ perspective on the proposal, and will take those comments into account as we consider the best methodology for calculating the specialty mix for low volume services in future rulemaking.

● Crosswalk certain low volume physician specialties : Crosswalk the utilization of certain specialties with relatively low PFS utilization to the associated specialties.

• Physical therapy utilization : Crosswalk the utilizat ion associated with all physical therapy services to the sp ecialty of physical therapy.

• Identify professional and technical serv ices not identified under the usual TC
and 26 modifiers : Flag the services that are PC a nd TC services, but do not use TC and 26 modifiers (for example, elec trocardiograms). This flag associates the PC and TC with the associated global code for use in creati ng the indirect PE RVUs . For example, the professional service, CPT code 93010 (Electro cardiogram, routine EC G with at least 12 leads; interpretation and report only), is associated with the global service, CPT code 93000 (Electrocardiogram, routine ECG with at least 12 leads; with interpretation and report).38

• Payment modifiers : Payment modifiers are accounted for in the creation of the file consistent with current payment policy as implemented in claims processing. For example, services billed with the assist ant at surgery modifier are paid 16 percent of the PFS amount for that service; therefore, the uti lization file is modified to only account for 16 percent of any service that contains the assistant at surgery m odifier. Similarly, for t hose services to which volume adjustments are made to account for the pa yment modifiers, time adjustments are applied as well. For time adjustments to surgical serv ices, the intraoperative portion in the physician time file is used; where it is not present, the intraoperative percentage from the payment files used by Medicare contractors to process Medicare claims is used instead. Where neither is available, we use the payment adjustment ratio to adjust the time accordingly. Table 2 details the manner in which the modifiers are applied. TABLE 2: Application of Paymen t Modifiers to Utilization Files Modifier Description Volume Adjustment Time Adjustment 80,81,82 Assistant at Surgery 16% Intraoperative portion AS Assistant at Surgery – Physician Assistant 14% (85% * 16%) Intraoperative portion 50 or LT and RT Bilateral Surgery 150% 150% of physician time 51 Multiple Procedure 50% Intraoperative portion 52 Reduced Services 50% 50% 53 Discontinued Procedure 50% 50% 54 Intraoperative Care only Preoperative + Intraoperative Percentages on the payment files used by Medicare contractors to process Medicare claims Preoperative + Intraoperative portion

55 Postoperative Care only Postoperative Percentage on the payment files used by Medicare contractors to process Medicare claims Postoperative portion39
62 Co-surgeons 62.5% 50% 66 Team Surgeons 33% 33% We also make adjustments to volume and time that correspond to other payment rules, including special multiple procedure endoscopy ru les and multiple procedure payment reductions (MPPR) including the final ophthalmology and ca rdiovascular diagnostic services MPPR discussed in section II.B.4. of this final rule with comment period. We note that section 1848(c)(2)(B)(v) of the Act exempts certain redu ced payments for multiple imaging procedures and multiple therapy services from the budge t-neutrality calculation under section 1848(c)(2)(B)(ii)(II) of the Act. These MPPRs are not in cluded in the development of the
RVUs. For anesthesia services, we do not apply adjustments to volume since the average allowed charge is used when simulating R VUs and therefore incl udes all discounts. A time adjustment of 33 percent is made only fo r medical direction of two to four cases since that it is the only occasion where time units are duplicative.
Comment : One commenter expressed concern rega rding the accuracy of the 33 percent time adjustment made for these services. Response : We note that we did not make a ny proposals regarding the 33 percent time adjustment for medical direction in the CY 2013 PFS proposed rule. As such, we do not believe it would be appropriate to modify that figure in this final rule. However, we would welcome any independently verifiable data that could in form the accuracy of our assumption regarding duplicative time units. The 33 percent time adjustme nt effectively assumes medical direction of three cases. We would consider any such data for future rulemaking.

● Work RVUs : The setup file contains the work RVUs from this final rule with comment period. (6) Equipment Cost Per Minute40 The equipment cost per minute is calculated as: (1/(minutes per year * usage)) * price * ((interest rate/(1-(1/((1 + interest rate)^ life of equipment)))) + maintenance) Where: minutes per year = maximum minutes per ye ar if usage were continuous (that is, usage = 1); generally 150,000 minutes. usage = 0.5 is the standard equipment utilization assumption; 0.75 for certain expensive diagnostic imaging equipment (see 74 FR 61753 through 61755 and section II.A.3. of the CY 2011 PFS final rule with comment period). price = price of the particular piece of equipment. interest rate = sliding scal e (see proposal below) life of equipment = useful life of th e particular piece of equipment. maintenance = factor for maintenance; 0.05. The interest rate we have previously used was proposed and finalized during rulemaking for CY 1998 PFS (62 FR 33164). In the CY 2012 proposed rule (76 FR 42783), we solicited comment regarding reliable data on current prevailing loan rates for small businesses. In response to that request, the AMA RUC recommended that rather than applying the same interest rate across a ll equipment, CMS should consider a “sliding scale” approach which varies the interest ra te based on the equipment cost, useful life, and SBA (Small Business Administration) maximum interest rates for different categories of loan size and maturity. The ma ximum interest rates for SBA loans are as follows:

● Fixed rate loans of $50,000 or more must not exceed Prime plus 2.25 percent if the maturity is less than 7 years, and Prime plus 2.75 percent if the maturity is 7 years or

more.41

● For loans between $25,000 and $50,000, maximum rates must not exceed Prime plus 3.25 percent if the maturity is less than 7 years, and Prime plus 3.75 percent if the maturity is 7 years or more.

● For loans of $25,000 or less, the maximum interest rate must not exceed Prime plus 4.25 percent if the maturity is less than 7 years, and Prime plus 4.75 percent, if the maturity is 7 years or more. The current Prime rate is 3.25 percent. Based on that recommendation, for CY 2013, we proposed to use a “sliding scale” approach based on the current SBA maximum in terest rates for different categories of loan size (price of the equipment) and ma turity (useful life of the equipment). Additionally, we proposed to update this assumption through annual PFS rulemaking to account for fluctuations in the Prime rate and/or changes to the SBA’s formula to determine maximum allowed interest rates.
Comment: Both MedPAC and the AMA RU C supported the proposal. MedPAC stated: We support CMS’s proposal to use more accurate interest rate information because this will improve the accuracy of practice expense payment rates and redistribute dollars from overvalue d codes to undervalued codes. The AMA RUC commented: The RUC appreciates that CMS intends to adopt the RUC recommendation of implementing a “sliding scale” for the in terest rate utilized in computing equipment costs. Other commenters, also supported the proposal. However, while physician organizations that represent specialties that provide medical equipment intensive services and medical equipment manufacturers generally acknowledged that the interest rate used42 in the calculation had not been updated in over 12 years, they did not support the specific proposed update approach. These commenter s assertions included: the proposal is “overly complicated” to administer since the in terest rates vary by loan size and maturity, and interest rates can fluctuate; the SBA loan program is designed to encourage loans to small businesses so the SBA rates are below market rates unrelated to the cost of capital for physician practices; the proposed methodology may be inconsistent with the statute since it does not reflect relative resources; CM S should factor in the opportunity cost for practices that pay cash for the equipment (a weighted average cost of capital (WACC) approach) using WACC measures available in the private sector; CMS should transition this policy given the investments in equipmen t that have already been made; CMS should use a multiyear average of the Prime rate rath er than the most recent Prime rate in the calculation; and, CMS should only u pdate the interest rate ever y few years to help ensure more stable practice expenses. Response: We agree with MedPAC, the AMA RUC, and the commenters who supported our proposed approach for the intere st rate calculation. Our proposed approach recognizes that the goal of the practice expe nse methodology is to calculate, as accurately as possible given the available data sources, the relative resources required to furnish services that are paid under the physician fee schedule. To continue to use an 11 percent interest rate assumption in the calculati on of the equipment por tion of the practice expense RVUs when this rate does not refl ect a market rate would unnecessarily distort this relativity. We are unawa re of, nor did commenters sugge st, a readily available and transparent data source that specifically pr ovides nationally repres entative data on the typical interest rates char ged to physicians when obtai ning financing for medical equipment. We believe that the use of th e SBA maximum loan rates leads to a more reasonable estimate of relative resource used across the fee schedule and, consistent with43
the MedPAC comment, that the continued us e of an 11 percent interest rate would inappropriately skew physician fee schedul e relativity towards equipment intensive services. Additionally, we disagree that the maximu m SBA loan rates are not sufficient as an assumption for the rate at which a typi cal physician practice w ould obtain financing, nor did the commenters offer nationa lly representative data indicating that this is the case. We agree with commenters that, in an ideal world, the interest rate assumption used in the equipment calculation would expl icitly factor in the opportunity costs for practices that pay cash for the equipment (a WACC approach) and not just the cost of financing. However, as with the interest ra tes typically charged to physicians for medical equipment financing, we are una ware of any nationally repres entative data source that would provide the opportunity cost for physician practices deciding on purchasing medical equipment. Some commenters sugg ested we use proprietary WACC measures designed for industry and company stock valu ations. We do not believe it would be appropriate to use proprietary measures in this calculation, no r do we believe that measures developed to value the stock prices of individual medical equipment companies or the medical device industry are necessar ily applicable to the opportunity costs of typical medical practices. Also, we do not ag ree that the opportunitycost of a physician practice purchase of medical equipment, if known or estimable, would exceed the SBA maximum loan rates. We also do not believe that our proposal is overly complicated to administer. The Prime rate is readily available, as are the SBA loan maximums. As such, we believe our proposal is a very transparent approach. We stated that we would update the rate through our annual PFS rulemaking process. In re sponse to comments on this aspect of our proposal, we are clarifying that we generally in tend to update the interest rate calculation44 through future rulemaking when we broadly update one or more of the other direct practice expense inputs, such as pricing or labor wage rates, to maintain relatively between the practice expense components. Gi ven that we do not anticipate updating the interest rate assumption ever y year, we do not believe it is necessary to use a rolling average in the calculation. Periodic updates us ing the most recent Prime rate will balance commenters’ desire for stability in the PE R VUs with the need to maintain appropriate relativity under the PFS. We also do not believe a tran sition is appropriate in this situation. We believe it is important to update the interest rate assumptions to appropriately adjust the relativ ity of equipment in relation to other PE inputs and the relation of equipment intensive servi ces to other services on the PFS. In summary, we are finalizing without m odification our proposal to use a “sliding scale” approach based on the current SBA maxi mum interest rates for different categories of loan size (price of the equipment) and matu rity (useful life of the equipment). We will update the interest rate assumption through PFS rulemaking to account for fluctuations in the Prime rate and/or changes to the SB A’s formula to determine maximum allowed interest rates. We are clarifying that we generally intend to update the interest rate calculation through future rulemaking only in ye ars when we broadly update one or more of the other direct practice expense input s. Accordingly, we anticipate updating the interest rate calculation less frequently than annually. The effects of this policy on direct equi pment inputs are reflected in the CY 2013 direct PE input database, available on the CMS website under the downloads for the CY 2013 PFS final rule with comment period at http://www.cms.gov/PhysicianFeeSched/

. Additionally, we note that the PE RVUs in cluded in Addendum B reflect this policy.TABLE 3: CALCULATION OF PE RVUS UNDER METHODOLOGY FOR SELECTED CODESStep Source Formula99213 Officevisit, estNonfacility33533 CABG,arterial, singleFacility71020 Chest xray Nonfacility71020-TC Chestx-ray Nonfacility71020-26 Chestx-ray Nonfacility93000ECG, completeNonfacility93005ECG, tracingNonfacility93010ECG,reportNonfacility(1) Laborcost (Lab)Step 1 AMA13.3277.525.745.740.006.126.120.00(2) Supplycost (Sup)Step 1 AMA2.980.003.393.390.001.191.190.00(3)Equipmentcost (Eqp)Step 1 AMA0.170.587.247.240.000.110.110.00(4) Directcost (Dir)Step 1 '=(1)+(2)+(3)16.4878.116.3816.380.007.427.420.00(5) Directadjustment(Dir. Adj.)Steps 2-4 See footnote*0.59890.59890.59890.59890.59890.59890.59890.5989(6)AdjustedLaborSteps 2-4=Labor *Dir Adj=(1)*(5)7.9846.433.443.440.003.673.670(7)AdjustedSuppliesSteps 2-4=Eqp * DirAdj=(2)*(5)1.790.002.032.030.000.720.720(8)AdjustedEquipmentSteps 2-4=Sup * DirAdj=(3)*(5)0.10.354.344.340.000.060.060(9)AdjustedDirectSteps 2-4 =(6)+(7)+(8)9.8746.789.819.810.004.444.440(10)ConversionFactor (CF)Step 5 PFS34.037634.037634.037634.037634.037634.037634.037634.0376(11) Adj.labor costconvertedStep 5=(Lab * DirAdj)/CF=(6)/(10)0.231.360.10.10.000.110.110.00(12) Adj.supply costconvertedStep 5=(Sup * DirAdj)/CF=(7)/(10)0.0500.060.060.000.020.020.0046Step Source Formula99213 Officevisit, estNonfacility33533 CABG,arterial, singleFacility71020 Chest xray Nonfacility71020-TC Chestx-ray Nonfacility71020-26 Chestx-ray Nonfacility93000ECG, completeNonfacility93005ECG, tracingNonfacility93010ECG,reportNonfacility(13) Adj.equipmentcostconvertedStep 5=(Eqp * DirAdj)/CF=(8)/(10)0.000.010.130.130.000.000.000.00(14) Adj.direct costconvertedStep 5=(11)+(12)+(13)0.291.370.290.290.000.130.130.00(15) WorkRVUSetup File PFS0.9733.750.220.000.220.170.000.17(16)Dir_pctSteps 6,7 Surveys0.310.180.310.310.310.310.310.31(17)Ind_pctSteps 6,7 Surveys0.690.820.690.690.690.690.690.69(18) Ind.Alloc.Formula(1st part)Step 8 See Step 8((14)/(16)*(17)((14)/(16)*(17)((14)/(16)*(17)((14)/(16)*(17)((14)/(16)*(17)((14)/(16)*(17)((14)/(16)*(17)((14)/(16)*(17)(19) Ind.Alloc.(1stpart)Step 8 See 180.876.430.710.710.000.320.320.00(20) Ind.Alloc.Formula(2nd part)Step 8 See Step 8(15)(15)(15+11)(11)(15)(15+11)(11)(15)(21) Ind.Alloc.(2ndpart)Step 8 See 200.9733.750.320.100.220.280.110.17(22)IndirectAllocator(1st + 2nd)Step 8 =(19)+(21)1.8440.181.030.810.220.600.430.1747Step Source Formula99213 Officevisit, estNonfacility33533 CABG,arterial, singleFacility71020 Chest xray Nonfacility71020-TC Chestx-ray Nonfacility71020-26 Chestx-ray Nonfacility93000ECG, completeNonfacility93005ECG, tracingNonfacility93010ECG,reportNonfacility(23)IndirectAdjustment(Ind. Adj.)Steps 9-11SeeFootnote**0.40370.40370.40370.40370.40370.40370.40370.4037(24)AdjustedIndirectAllocatorSteps 9-11=Ind Alloc *Ind Adj0.7416.220.420.330.090.240.170.07(25) Ind.PracticeCost Index(IPCI)Steps 12-161.080.790.930.930.930.920.920.92(26)AdjustedIndirectStep 17= Adj.IndAlloc * PCI=(24)*(25)0.8112.760.390.30.080.220.160.06(27) PERVUStep 18=(Adj Dir +Adj Ind) *budn=((14)+(26)) *budn1.0914.120.670.590.080.350.290.06Note: PE RVUs in table 2, row 28, may not match Addendum B due to rounding. * The direct adj = [current pe rvus * CF * avg dirpct]/[sum direct inputs] =[Step 2]/[Step 3]** The indirect adj = [current pe rvus * avg ind pct]/[sum of ind allocators] = [Step 9]/[Step 10]Note: The use of any particular conversion factor (CF) in Table 3 to illustrate the PE calculation has no effect on the resulting RVUs.3. Changes to Direct PE Inputs for Specific Services In this section, we discuss ot her specific CY 2013 proposals a nd changes related to direct PE inputs for specific services. The changes we proposed and are finalizing are included in the final rule CY 2012 direct PE database, whic h is available on the CMS Web site under the supporting data files for the CY 2012 PFS final rule with comment period at www.cms.gov/PhysicianFeeSched/ . We note that we address comme nts on the interim direct PE inputs established in the CY 2012 PFS final rule with comment pe riod in section II.M. of this final rule with comment period. a. Equipment Minutes for Interrogation Device Evaluation Services It has come to our attention that the p acemaker follow-up system (EQ138) associated with two interrogation device management service codes does not have minutes allocated in the direct PE input database. Based on our analysis of these services, we be lieved that 10 minutes should be allocated to the equipment for each of the following CPT codes: 93294 (Interrogation device evaluation(s) (remote), up to 90 days; sing le, dual, or multiple lead pacemaker system with interim physician analysis, review(s) and report(s)), and 93295 (Interrogation device evaluation(s) (remote), up to 90 days; single, dual, or multiple lead implantable cardioverterdefibrillator system with interim physician analysis, review(s ) and report(s)). Therefore, the direct PE input database was modified to allo cate 10 minutes to the pacemaker follow-up system for CPT codes 93294 and 93295.
Comment : One commenter expressed support for this modification. Response : We appreciate the support for the modi fication and will maintain the allocated equipment minutes in the final direct PE input database. b. Clinical Labor for Pulmonary Rehabi litation Services (HCPCS Code G0424) It has come to our attention that the dire ct PE input database includes 15 minutes of49

clinical labor time in the nonfacility setting al located for a CORF social worker/psychologist (L045C) associated with HCPCS code G0424 (P ulmonary rehabilitation, including exercise (includes monitoring), one hour, pe r session, up to two sessions per day). Based on our analysis of this service, we believed that these 15 minutes should be a dded to the 15 minutes currently allocated to the Respiratory Ther apist (L042B) associated with th is service. Therefore, we proposed to modify the direct PE input databa se to allocate 15 additional minutes to the Respiratory Therapist (L042B) (f or a total of 30 minutes) and to delete the CORF social worker/psychologist (L045C) asso ciated with HCPCS code G0424.
Comment : One commenter supported the modifi cation as accurate and fair. Another commenter suggested that the appr opriate clinical staff time for the code should be 60 minutes since the code describes an hour long session. Furthermore, the same commenter expressed opposition to reassigning the 15 minutes to the Resp iratory Therapist because the rate per minute of the Respiratory Therapist is lower than the rate per minute of the CORF social worker/psychologist and the change, however mode st, may potentially reduce the PE RVUs for the service. Response: We appreciate the support for the modification and understand the commenter’s concerns. We recogni ze that for many services with code descriptors that include procedure time assumptions, the number of clin ical labor minutes allo cated during the service period corresponds to the time as described by the code. However, as we explained in the CY 2011 PFS final rule with comment period (75 FR 73299), because pulmonary rehabilitation services reported under HCPCS code G0424 can be furnished either individually or in groups, we believe that 30 minutes of respiratory therap ist time would be more appropriate for valuing the typical pulmonary rehabilitation service. We also recognize that reclassifying the direct PE input labor category from CORF social worker/psychologist to Respiratory Therapist for 15 minutes will reduce the direct labo r costs used in calculating PE RV Us for the service. However,50 we continue to believe that the Respiratory Ther apist is the most appropriate labor category to include as a direct PE input for this service. After consideration of the comments we recei ved, we are finalizing the modification of the direct PE labor inputs for this service to allocate 15 additional minutes to the Respiratory Therapist (L042B) (for a total of 30 minutes) and to delete the CO RF social worker/psychologist (L045C) associated with HCPCS code G0424. c. Transcranial Magnetic Stimulation Services For CY 2011, the CPT Editorial Panel converted Category III CPT codes 0160T and 0161T to Category I status (CPT codes 90867 (The rapeutic repetitive transcranial magnetic stimulation (TMS) treatment; initial, including cortical mapping, motor threshold determination, delivery and management), and 90868 (Therapeutic repetitive transcrani al magnetic stimulation (TMS) treatment; subsequent delivery and mana gement, per session)), which were contractor priced on the PFS. For CY 2012, the CPT Edito rial Panel modified CPT codes 90867 and 90868, and created CPT code 90869 ((Therapeutic re petitive transcranial magnetic stimulation (TMS) treatment; subsequent motor threshold re-d etermination with delivery and management.) In the CY 2012 PFS final rule with comment period, we established interim final values based on refinement of RUC-recommended work RVUs, dire ct PE inputs, and malpractice risk factor crosswalks for these services (76 FR 73201). Subsequent to the development of interim fina l PE RVUs, it came to our attention that the application of our usual PE met hodology resulted in anomalous PE va lues for these services. As we explain in section II.A.2.c.2 of this final rule with comment period, for a given service, we use the direct costs associated with a service (c linical staff, equipment, and supplies) and the average percentage that direct costs represent of total costs (based on survey data) across the specialties that furnish the service to de termine an initial indirect allocator. For services almost exclusively furnished by one specialty, the average percentage of51

indirect costs relative to direct costs would ordinarily be used to determine the initial indirect allocator. For specialties that typically incur signif icant direct costs relative to indirect costs, the initial indirect allocator for their services is generally lower than for the specialties that typically incur lower direct costs relative to indirect costs. Relative to direct costs, the methodology generally allocates a greater propor tion of indirect PE to services furnished by psychiatrists, for example, than to services furnished by specialti es that typically incur significant direct costs, such as radiation oncologists. In the case of TMS, however, the direct costs incurred by psychiatrists reporting the codes far exceed the direct costs typical to any other service predominantly furnished by psychiatrists. This drastic difference in th e direct costs of TMS relative to most other services furnished by psychiatrists, results in anomalous PE values since code-level indirect PE allocati on relies on typical resource costs for the specialties that furnish the service. In other words, the amount of indir ect PE allocated to TMS services is based on the proportion of indirect expense to di rect expense that is typical of other psychiatric services, and is not on par with other services that require similar investments in capital equipment and highcost, disposable supplies. Historically, we have contractor-priced (meaning our claims processing contractors develop payment rates) for services with resour ce costs that cannot be appropriately valued within the generally ap plicable PE methodology used to pric e services across the PFS. Because there is no mechanism to develop appropriate payment rates for these services within our current methodology, we proposed to contractor price these codes for CY 2013.
Comment : One commenter objected to the propos al to contractor price these codes for CY 2013 and suggested that CMS sh ould establish PE RVUs using the generally applicable PE methodology and must endeavor in ensuing rulema king to revise the methodology to refine any values the agency views as “anomalous.” Th e commenter also questioned CMS’s assumption that the direct costs for psychiat rists who furnish these services “f ar exceed” the direct costs for52 psychiatrists who do not furnish these services. The commenter stated that CMS made this assessment without any empirical support and th at CMS needs to conduct a survey or obtain other data from psychiatrists be fore drawing any conclusions re garding the appropriateness of Medicare payment rates on this basis. Response : We understand the commenter’s objec tions, but as we explained in the proposal, we do not believe that there is a mech anism within the current methodology that allows us to develop appropriate payment rates for these services. We agree with the commenter that it may be appropriate to consid er potential change s to the practice expense methodology to accommodate changing circumstances of medical practice. We do not agree with the commenter, however, that we have no means to pay appropriately for services when we recognize areas where the prac tice expense methodology is inad equate and that we must establish national RVUs based on that met hodology, even when it does not accommodate the unique circumstances of particular services. Instead, we believe that in outlier cases, contractor pricing allows Medicare to pay more appropria tely for particular services furnished to beneficiaries. In our proposal, we pointed out that the di rect costs incurred by psychiatrists reporting the codes far exceed the direct costs typical to any other service predominantly furnished by psychiatrists. The commenter objected to this assertion and claimed it was made without any empirical support. We made that assertion base d on comparing the direct practice expense input costs for transcranial magnetic s timulation services and the current direct practice expense input costs in the direct PE database for services predominantly furnished by the specialty based on Medicare claims data. In our examination of 20 frequently billed psychi atry services (where greater than half of the Medicare allowed services were report ed by psychiatrists) , the total direct costs (clinical labor, disposable medical supplies, or medical equi pment) in the direct PE input database summed to under $ 10 for all but 3 of th ese 20 services. Examples of these services53 include CPT codes 90807 (Individual psychothera py, insight oriented, behavior modifying and/or supportive, in an office or outpatient facility, approximatel y 45 to 50 minutes face-to-face with the patient; with medical evaluation and management services), 90862 (Pharmacologic management, including prescription, use, and revi ew of medication with no more than minimal medical psychotherapy), and 90845 (P sychoanalysis). For the thr ee where the direct PE input costs summed to greater than $10, HCPCS code M 0064 (Brief office visit fo r the sole purpose of monitoring or changing drug prescr iptions used in the treatment of mental psychoneurotic and personality disorders), and CPT codes 90865 (Nar cosynthesis for psychiatric diagnostic and therapeutic purposes (eg, sodium amoba rbital (Amytal) interview)), and 90870 (Electroconvulsive therapy (incl udes necessary monitoring )) , the service with the highest direct cost sum was $32.24. In contrast, the transcrani al magnetic stimulation services treatment delivery (CPT code 90867) included direct PE inputs that summed to direct costs of $145.19. The disparity between the TMS direct costs and the direct costs in other frequent psychiatry codes was the basis for our asserti on that the direct costs for this service far exceeded the direct costs typical to any other service predominantly fu rnished by psychiatrists. Thus, we continue to believe our decision to c ontractor price these codes is the proper one.
Comment : Another commenter requested that CMS use the existing methodology to price the codes or contractor pr ice the codes. This commenter also urged CMS to consider alternate sources of data for re source costs as they become ava ilable, or to make appropriate future refinements to the practice expense methodology. Response : We appreciate the commenter’s suppor t for our proposal as a suitable means of pricing the services. We will consider appropriate means to develop national prices for these services in the context of potential changes to the prac tice expense methodology and the availability of new data sources. After consideration of thes e public comments, we are finalizing our proposal to54 contractor price CPT codes 90867, 90868, and 90869 for CY 2013. d. Spinal Cord Stimulation Trial Procedures in the Nonfacility Setting Stakeholders have recently brought to our attention that CPT code 63650 (Percutaneous implantation of neurostimulator electrode array, ep idural) is frequently fu rnished in the physician office setting but is not priced in that setting. We note that the valuation of a service under the PFS in particular settings does not address whethe r those services are medically reasonable and necessary in the case of individua l patients, including being furnis hed in a setting appropriate to the patient’s medical needs and condition. However, because thes e services are being furnished in the nonfacility setting, we believed that CPT code 63650 should be reviewed to establish appropriate nonfacility inputs. We proposed to review CPT code 63650 and requested recommendations from the AMA RUC and other public commenters on the appropriate physician work RVUs (as measured by time and inte nsity), and facility a nd nonfacility direct PE inputs for this service. We understand that disp osable leads comprise a significant resource cost for this service and are currently separately reportable to Medicare for payment purposes when the service is furnished in the physician office setting. Disposable medical supplies are not considered prosthetic devices paid under the Durable Medical Equipment, Prosthetic/Orthotic, and Supplies (DMEPOS) fee schedul e and generally are incorporated as nonfacility direct PE inputs to PE RVUs. We sought comment on esta blishing nonfacililty PE RVUs for CPT code
63650.
Comment : Several commenters expressed concerns regarding the possibility of establishing nonfacility PE RVUs for this service based on the a ssumption that the nonfacility PFS payment rate would be lower than the ra te paid by the Medicar e hospital outpatient prospective payment system (OPPS). These comm enters stated that the supply, personnel, and administration costs are higher in the non-facility setting than in the facility setting and that current Medicare payment for L8680 under the DMEP OS fee schedule offsets the difference in55 costs between the facility and nonf acility setting. Many of these comm enters also stated that it is more cost effective for the Medicare program for these services to be fu rnished in the nonfacility setting. These commenters also stated that it is more convenient for patients to receive this service in the nonfacility setting, so that Medicare should not implement nonfacility payment rates because doing so might discourage practit ioners from furnishing the service in the nonfacility setting. Response : We understand the commenters’ in terest in ensuri ng that Medicare beneficiaries retain access to th e service in the nonf acility setting. We do not agree with the commenters’ underlying assumption that developing accurate payment rates for the service in the nonfacility setting will n ecessarily deter practitioners from furnishing the service to Medicare beneficiaries outside the facili ty setting. Additionally, we do not know how to reconcile the contradictory contentions of many individual commenters that the costs of furnishing the services in the nonfacility setting are greater so that payment rates should be higher, but furnishing services there would still be more cost effective for Medicare.
Comment : One commenter supported the proposal to create nonfacility RVUs for this service since it would reduce ove rutilization of the service and lower the likelihood of fraud. Response : We appreciate the support for the pr oposal, and we generally agree that developing accurate payment rates enc ourages appropriate utilization.
Comment : One commenter stated that CMS s hould continue to provide payment for HCPCS code L8680 until non-facility PE inputs for CPT code 63650 including the leads have been developed. Response : We appreciate the commenter’s concer ns. We would continue a mechanism to provide payment for the disposable leads usedin furnishing the service while we develop nonfacility PE inputs. We also agree that once a practice expense payment reflects these disposable leads, that a separate payment mech anism would no longer be necessary.56

Comment : The AMA RUC agreed that the direct practice expense inputs for the service should be reviewed to establish appropriate inputs in both the f acility and nonfacility setting. After consideration of the comments we received regarding our proposal to establish nonfacility PE RVUs for CPT code 63650 (Percu taneous implantation of neurostimulator electrode array, epidural), we continue to believe that it would be appropria te to do so since these services are being furnished in the nonfacility setting. The AM A RUC expects to review the direct PE inputs for this service during CY 2013. We anticipate receiving recommendations from the AMA RUC for the CY 2014 PFS, and we request comments from other stakeholders regarding the appropriate direct PE inputs for this service B. Potentially Misvalued Codes Under the Physician Fee Schedule 1. Valuing Services Under the PFS To value services under the PFS, section 1848( c) of the Act requires the Secretary to determine relative values for physicians’ serv ices based on three components: work; practice expense (PE); and malpractice. Section 1848(c)(1 )(A) of the Act defines the work component to include “the portion of the res ources used in furnishing the service that reflects physician time and intensity in furnishing the service.” In add ition, section 1848(c)(2)(C)(i) of the Act specifies that “the Secretary shall determ ine a number of work relative value units (RVUs) for the service based on the relative resources in corporating physician time and in tensity required in furnishing the service.” As discussed in detail in sect ions II.B.1.b. and II.B.1.c. of th is final rule with comment period, the statute also defines the PE and malpractice components and provides specific guidance in the calculation of th e RVUs for each of these components. Section 1848(c)(1)(B) of the Act defines the PE component as “the portion of the resources used in furnishing the service that reflects the general categorie s of expenses (such as office re nt and wages of personnel, but excluding malpractice expenses) comprising practi ce expenses.” Secti on 1848(c)(1)(C) of the57 Act defines the malpractice component as “the po rtion of the resources used in furnishing the service that reflects malpractice expenses in furnis hing the service.” Clause (ii) and clause (iii) of section 1848 (c)(2)(C) of the Act specify that PE and malpr actice expense RVUs shall be determined based on the relative PE/malpractice expense resources involved in furnishing the service. Section 1848(c)(2)(B) of the Ac t directs the Secretary to co nduct a periodic review, not less often than every 5 years, of the RVUs established under the PFS. On March 23, 2010, the Affordable Care Act was enacted, further requiri ng the Secretary to periodically identify and review potentially misvalued codes and make appr opriate adjustments to the relative values of those services identified as being potentially misvalued. Section 1848(c)(2)(K) to the Act requires the Secretary to periodically identify pot entially misvalued services using certain criteria and to review and make appropriate adjustments to the relative valu es for those services. Section 1848(c)(2)(L) of the Act requires the Secretary to develop a pr ocess to validate the RVUs of certain potentially misvalued codes under the PFS, identified using the same criteria used to identify potentially misvalued codes, and to make appropriate adjustments. As discussed in section I.B.1.a. of this fi nal rule with comment period, each year we develop and propose appropriate adjustment s to the RVUs, taking into account the recommendations provided by the American Medi cal Association Specialty Society Relative Value Scale Update Committee (AMA RUC), the Medicare Payment Advisory Commission (MedPAC), and others. For many years, the AMA RUC has provided us with recommendations on the appropriate relative values for new, revi sed, and potentially misvalued PFS services. We review these recommendations on a code-by-code basis and consider thes e recommendations in conjunction with the recommendati ons of other public commenters, and with analyses of data sources, such as claims data, to inform the deci sion-making process as authorized by the law. We may also consider analyses of physician tim e, work RVUs, or direct PE inputs using other58 data sources, such as Department of Vete ran Affairs (VA) National Surgical Quality Improvement Program (NSQIP), the Society for Thoracic Surgeons (STS), and the Physician Quality Reporting Initiative (PQRI) databases. In addition to considering the most recently available data, we also assess the results of physicia n surveys and specialty recommendations submitted to us by the AMA RUC. We conduct a c linical review to assess the appropriate RVUs in the context of contemporary medical practice. We note that section 1848(c)(2)(A)(ii) of the Act authorizes the use of extrapolation and other techniques to determine the RVUs for physicians' services for which specific data are no t available, in addition to taking into account the results of consultations with organizations representing physicians. In accordance with section 1848(c) of the Act, we de termine appropriate ad justments to the RVUs, explain the basis of these adjustments, and respond to public co mments in the PFS proposed and final rules. 2. Identifying, Reviewing, and Validating the RVUs of Potentially Misvalued Services on the
PFS a. Background In its March 2006 Report to the Congress, MedP AC noted that “misvalued services can distort the price signals for physic ians’ services as well as for ot her health care services that physicians order, such as hospital services.” In that same report MedPAC postulated that physicians’ services under the PFS can become mi svalued over time for a number of reasons: For example, MedPAC stated, “when a new servi ce is added to the PFS, it may be assigned a relatively high value because of the time, technica l skill, and psychologica l stress that are often required to furnish that service. Over time, the work required for certain services would be expected to decline as physicians become more familiar with the service and more efficient in furnishing it.” That is, the amount of physician wo rk needed to furnish an existing service may decrease as physicians build experience furnishi ng that service. Services can also become overvalued when PEs decline. This can happen wh en the costs of equipment and supplies fall, or59 when equipment is used more frequently than is estimated in the PE methodology, reducing its cost per use. Likewise, services can become undervalued when physician work increases or PEs rise. In the ensuing years since MedPAC’s 2006 report, additional groups of potentially misvalued services have been identified by th e Congress, CMS, MedPAC, the AMA RUC, and other stakeholders. In recent years, CMS and the AMA RUC have taken increasingly si gnificant steps to address potentially misvalued c odes. As MedPAC noted in its March 2009 Report to Congress, in the intervening years sin ce MedPAC made the initial re commendations, “CMS and the AMA RUC have taken several steps to improve th e review process.” Most recently, section 1848(c)(2)(K)(ii) of the Act dire cted the Secretary to specific ally examine, as determined appropriate, potentially misvalued serv ices in seven categories as follows:

● Codes and families of codes for which there has been the fastest growth;

● Codes and families of codes that have experienced substantial changes in PEs;

● Codes that are recently establishe d for new technologies or services;

● Multiple codes that are frequently b illed in conjunction with furnishing a single service;

● Codes with low relative values, particularly those that are often billed multiple times for a single treatment;

● Codes which have not been subject to revi ew since the implementation of the PFS (the so-called ‘Harvard-v alued codes’); and

● Other codes determined to be appropriate by the Secretary. Section 1848(c)(2)(K)(iii) of the Act also specifies that the Secretary may use existing processes to receive recommendati ons on the review and appropriate adjustment of potentially misvalued services. In add ition, the Secretary may conduct su rveys, other data collection activities, studies, or other analys es, as the Secretary determines to be appropriate, to facilitate60 the review and appropriate adjustment of potenti ally misvalued services . This section also authorizes the use of analytic contractors to identif y and analyze potentially misvalued codes, conduct surveys or collect data, and make r ecommendations on the review and appropriate adjustment of potentially misvalued services. Additionally, this section provides that the Secretary may coordinate the review and adjust ment of any RVU with the periodic review described in section 1848(c)(2)(B) of the Act. Finally, section 1848(c)(2)(K)(iii)(V) of the Act specifies that the Secretary may make appropr iate coding revisions (i ncluding using existing processes for consideration of coding changes) which may include consolidation of individual services into bundled code s for payment under the PFS. In addition to these requirements, section 3003(b)(1) of the Middle Class Tax Relief and Job Creation Act of 2012 (MCTRJCA) (Pub. L. 112- 96), requires that th e Secretary conduct a study that examines options for bundled or episod e-based payment to cove r physicians’ services currently paid under the PFS under section 1848 of the Act for one or more prevalent chronic conditions or episodes of care for one or more major procedures. In conducting the study, the Secretary shall consult with medical professiona l societies and other relevant stakeholders. Additionally, the study shall include an examination of related privat e payer payment initiatives. This section also requ ires that not la ter than January 1, 2013, the Secretary submit to certain committees of the Congress a report on the study . The report shall include recommendations on suitable alternative payment options for services paid under the PFS and on associated implementation requirements. Bundling is one method for aligning incentives for hospitals, post-acute care providers, physicians, and other practitioners to partner closely across all sp ecialties and settings that a patient may encounter to improve the patient’s experience of care. The typical goals of developing an effective bundled payment system are to improve quality, reduce costs, and promote efficiency. Current work on bundling serv ices paid under the PFS to date has been61 limited to targeting specific code s and sets of codes and repackag ing those codes into “bundles.” As detailed above, through the pot entially misvalued code s initiative we are currently identifying for review codes that are frequently billed togeth er and codes with low relative values billed in multiples. Many of the codes identified through these screens have been referred to the CPT Editorial Panel for the development of a comp rehensive or bundled code, and several bundled codes have already been created and valued. However, we believe that we now need to move beyond this “repackaging” of codes and examin e the potential of a larger bundled payment within the PFS. In response to section 3003(b )(1) of the MCTRJCA, we have consulted with medical professional societies, private payers , healthcare system administrators, and other stakeholders; met with other CMS staff involved in other bundling initiati ves; and performed an extensive literature review. Additionally, we ha ve had representatives of specialty groups such as radiation oncologists volunteer to work with us to create a bundl ed payment for their services. If we were to engage in a bundling project for ra diation therapy, we would want to do more than provide a single episode payment for the normal cour se of radiation thera py that aggregates the sum of the individual treatments. Radiation ther apy has many common side effects that can vary based on the type of cancer the patient has and how it is being treated. Common side effects associated with radiation therapy include fati gue, skin problems, eating problems, blood count changes, emotional issues such as depression, etc... If we were to engage in a bundling project that includes radiation therapy, we would be interested in explori ng whether it could also include treating and managing the side effects that resu lt from radiation therapy in addition to the radiation therapy itself. Such an episode-based payment would allow Medicare to pay for the full course of the typical radia tion therapy as well as the many medical services the patient may be receiving to treat side effects. We will continue to examine options for bundl ed or episode-based payments and will include our recommendations and implementatio n options in our repor t to the Congress.62 Following completion of this report, we will lo ok forward with interest to the view of stakeholders that are intere sted in testing some of th ese concepts within the PFS. b. Progress in Identifying and Revi ewing Potentially Misvalued Codes In accordance with our statutory mandate, we have identified and reviewed numerous potentially misvalued codes in all seven of the categories specified in section 1848(c)(2)(K)(ii) of the Act, and we plan to continue our work examining potentially misvalued codes in these areas over the upcoming years. In the current process, we identify potentially misvalued codes for review, and request recommendations from the AMA RUC and other public commenters on revised work RVUs and direct PE inputs for those codes. The AMA RUC, through its own processes, identifies po tentially misvalued codes for revi ew, and through our public nomination process for potentially misvalued codes esta blished in the CY 2012 PFS final rule, other individuals and stakeholder groups submit nomin ations for review of potentially misvalued codes as well. Since CY 2009, as a part of the annual potentia lly misvalued code review and Five-Year Review processes, we have reviewed over 1,000 potentially misvalued codes to refine work RVUs and direct PE inputs. We have adopted appropriate work RVUs and direct PE inputs for these services as a result of these reviews. Our prior reviews of codes unde r the potentially misvalued c odes initiative have included codes in all seven categories sp ecified in section 1848(c)(2)(K)(ii) of the Act, listed above. A more detailed discussion of the extensive prio r reviews of potentially misvalued codes is included in the CY 2012 PFS final rule with comment period (76 FR 73052 through 73055). In the CY 2012 final rule with comment period, under the potentially misvalued codes category of “Other codes determined to be a ppropriate by the Secretary,” we finalized our proposal to review a list of th e highest PFS expenditure services, by specialty, that had not been recently reviewed (76 FR 73059 through73068). In the CY 2012 final rule with comment period63 we also finalized policy to consolidate the pe riodic reviews of physician work and PE at the same time (76 FR 73055 through 73958), and es tablished a process for the annual public nomination of potentially misvalue d services to replace the Five -Year review process (76 FR 73058 through 73059). Below we discuss th e CY 2013 PFS proposals that support our continuing efforts to appropriately identify, review , and adjust values for potentially misvalued codes. c. Validating RVUs of Potentially Misvalued Codes In addition to identifying and reviewi ng potentially misvalued codes, section 1848(c)(2)(L) of the Act specifies that the Secretary shal l establish a formal process to validate RVUs under the PFS. The validation process may in clude validation of work elements (such as time, mental effort and professional judgment, te chnical skill and physical effort, and stress due to risk) involved with furnishi ng a service and may also include validation of the pre-, post-, and intra-service time components of work. The Secret ary is directed, as part of the validation, to validate a sampling of the work RVUs of codes identified through any of the seven categories of potentially misvalued codes specified by section 1848( c)(2)(K)(ii) of the Ac t. Furthermore, the Secretary may conduct the validation using methods similar to those used to review potentially misvalued codes, including conducting surveys, othe r data collection activities, studies, or other analyses as the Secretary determines to be appr opriate to facilitate th e validation of RVUs of services. In the CY 2011 PFS proposed rule (75 FR 40068) and CY 2012 PFS proposed rule (76 FR 42790), we solicited public comments on possi ble approaches, methodologies, and data sources that we should consider for a validati on process. A summary of the comments along with our responses are included in the CY 2011 PFS final rule with comment period (75 FR 73217) and the CY 2012 PFS final rule with co mment period (77 FR 73054 through 73055). In September 2012 we entered into tw o contracts to assist us in validating RVUs of potentially64 misvalued codes; the implementatio n details for these contracts are currently under development. Contractors will explore models for the valida tion of physician work under the PFS, both for new and existing services. We plan to discuss these models further in future rulemaking. d. Improving the Valuation of the Global Surgical Package (1) Background We applied the concept of payment for a global surgical package under the PFS at its inception on January 1, 1992 (56 FR 59502). For each global surgical procedure, we establish a single payment, which includes payment for a packag e of all related servi ces typically furnished by the surgeon furnishing the procedure during th e global period. Each global surgery is paid on the PFS as a single global surgical package. Each global surgical package payment rate is based on the work necessary for the t ypical surgery and related pre- and post-operative work. The global period may include 0, 10, or 90 days of pos t-operative care, depending on the procedure. For major procedures, those with a 90-day gl obal period, the global surg ical package payment also includes services typical ly furnished the day prior to the day of surgery. Some global surgical packages have been valued by adding the RVU of the surgical procedure and all pre- and post- operative evaluation and management (E/M) services included in the global period. Others have been valued using magnitude estimation, in which case the overall RVU for the surgical package was determ ined without factoring in the specific RVUs associated with the E/M services in the global period. The number and level of E/M services identified with a global surgery payment are ba sed on the typical case. Even though a surgical package may have been developed with seve ral E/M services included, a physician is not required to furnish each pre- or post-operative visit to bill for the global surgical package. Similar to other bundled services on the PFS, when a global surgery code is billed, the bundled pre- and post-operative care is not sepa rately payable; surgeons or other physicians65 billing a surgical procedure, canno t separately bill for the E/M services that are included in the global surgical package. (2) Measuring Post-Operative Work The use of different methodologies for valu ing global surgical packages since 1992 has created payment rates that reflect a wide range of E/M services within the post-operative period. This is especially true among those with 90-day global periods. More recently reviewed codes tend to have fewer E/M services in the global pe riod, and the work RVUs of those E/M services are often accounted for in the value for the globa l surgical package. The values of global surgical packages reviewed less recently frequen tly do not appear to include the full work RVUs of each E/M service in the global surgical packag e, and the numbers of E/M services included in the post-operative period can be inconsiste nt within a family of procedures. In 2005, the HHS Office of Inspector General (OIG) examined whether global surgical packages are appropriately valued. In its repor t on eye and ocular surgeries, “National Review of Evaluation and Management Services Include d in Eye and Ocular Adnexa Global Surgery Fees for Calendar Year 2005” (A-05-07-00077), th e OIG reviewed a sample of 300 eye and ocular surgeries, and counted the actual number of face-to-face services in the surgeons’ medical records to establish whether the surgeon fu rnished post-operative E/M services. The OIG findings show that surgeons typically furnishe d fewer E/M services in the post-operative period than were identified with the global surgical package payment for each procedure. A smaller percentage of surgeons furnished more E/M services than were identified with the global surgical package payment. The OIG could only review th e number of face-to-face services and was not able to review the level of the E/M services that the surgeons furnished due to a lack of documentation in surgeons’ medical records. Th e OIG concluded that the RVUs for the global surgical package are too high because they incl ude the work of E/M services that are not typically furnished within the global period for the reviewed procedures.66 Following the 2005 report, the OIG continued to investigate E/M services furnished during the global surgical period. In Ma y 2012, the OIG published a report titled “Musculoskeletal Global Surgery Fees Often Di d Not Reflect the Number of Evaluation and Management Services Provided” (A-05-09-00053). For this investigation, the OIG sampled 300 musculoskeletal global surgeries and again found th at, for the majority of sampled surgeries, physicians furnished fewer E/M services than were identified as part of the global period for that service. Once again, a smaller percentage of su rgeons furnished more E/M services than were identified with the global surgical package paym ent. The OIG concluded that the RVUs for the global surgical package are too high because they include the work of E/M services that are not typically furnished within the global period for the reviewed procedures. In both reports, the OIG recommended that we adjust the number of E/M services identified with the global surgical payments to reflect the number of E/M services that are actually being furnished. Under the PFS, we do not ask surgeons to detail the component bundled services on their claim when billing for the global surgical package as we do providers furnishing bundled services under other Medicare pa yment systems. Since it is not necessary for a surgeon to identify the level or CPT code of the E/M services actua lly furnished during the global period, there is very lim ited documentation on the frequency or level of post-operative services. Without sufficient documentation, a revi ew of the medical record cannot accurately determine the number or level of E/M services fu rnished in the post-operative period. This is an area of concern, and is discussed in mo re detail later in this section. As noted above, section 1848(c )(2)(K) of the Act, which codified and expanded the potentially misvalued codes initiative that CM S had begun, requires that the Secretary identify and review potentially misvalued services with an emphasis on several categories, and recognizes the Secretary’s discretion to identify additional potentially misvalued codes. Several of the categories of potentially misvalued code s support better valuati on of global surgical67 package codes. We have made efforts to priori tize the review of RVUs for services on the PFS that have not been reviewed recently or for servi ces where there is a poten tial for misuse. One of the priority categories for review of potentially misvalued codes is services that have not been subject to review since the implementation of th e PFS (the so-called “Harvard-valued codes”). In the CY 2009 PFS proposed rule, we requested th at the AMA RUC engage in an ongoing effort to review the remaining Harvard-valued codes, focusing first on the high-volume codes (73 FR 38589). For the Fourth Five-Year Review ( 76 FR 32410), we requested that the AMA RUC review services that have not been reviewed since the original implem entation of the PFS with utilization greater than 30,000 (Harvard-val ued—Utilization > 30,000). In the CY 2013 PFS proposed rule, we proposed to review Harvard-valu ed services with annual allowed charges that totaled at least $10,000,000 (Harva rd-valued—Allowed charges ≥ $10,000,000), and requested recommendations from the AMA RUC and other public commenters on appropriate values for these services (77 FR 44741). Of the more than 1,000 identifie d potentially misvalued codes, just over 650 are surgical services with a global period of 0, 10, or 90 days. We have completed our review of 450 of these potentially misvalued surgical codes. As we stated in the CY 2013 PFS proposed rule, these efforts are important, but we believe the usua l review process does not go far enough to assess whether the valuation of global su rgical packages reflects the nu mber and level of post-operative services that are typically furn ished. To support our st atutory obligation to identify and review potentially misvalued services and to respond to the OIG’s concern that global surgical package payments are misvalued, we believe that we shoul d gather more information on the E/M services that are typically furnished with surgical pro cedures. Information regarding the typical work involved in surgical procedures with a global period is necessary to evaluate whether certain surgical procedures are appropr iately valued. While the AM A RUC reviews and recommends RVUs for services on the PFS, we complete our own assessment of those recommendations, and68 may adopt different RVUs. However, for procedur es with a global period, the lack of detail in claims data and documentation re strict our ability to review and assess the appropriateness of their RVUs. In the CY 2013 proposed rule, we requested comments on methods of obtaining accurate and current data on E/M services furnished as part of a global surgical pack age. We stated that we were especially interested in and invite d comments on a claims-based data collection approach that would include re porting E/M services furnished as part of a global surgical package, as well as other valid, re liable, generalizable, and robust data to help us identify the number and level of E/M services typically furn ished in the global surgical period for specific procedures. The following is summary of the comments we received regarding the methods of obtaining accurate and current data on E/M serv ices furnished as part of a global surgical package proposal.
Comment: Several commenters stated that the global payment methodology has restricted CMS’ ability to audit the accuracy of the current value of services as well as the accuracy of the AMA RUC recommendations for services with a global period. Many commenters offered recommendations on how CMS could validate the curre nt global surgical packages or obtain accurate and current data on E/M services furnished as a part of the global surgical package. Some commenters recommen ded that CMS establish auditable documentation requirements for inpatient and outpatient post-op erative visits, and many believed that these auditable post-operative vis it notes should follow E/M docum entation guidelines. Other commenters suggested that CMS adjust all surgic al services to a 0-day global period, require surgeons to bill post-operative E/M services sepa rately for payment purposes, and subject those billings to the same coding and documentation sta ndards and audits to which other practitioners are already subject. Several co mmenters noted that CMS could validate the global surgical69 packages with the hospital Diagnosis-Related Group (DRG) length of stay data, and that CMS could explore the use of surgical specialties’ re gistries to collect data on services furnished within the global period. Commenters also suggested that CMS could draw upon the OIG’s approach and review the medical record for a st atistically valid sample of claims and then extrapolate those results to clin ically similar families of codes. One commenter suggested that CMS could establish G-codes through which a large sample of surgeons might report the number and intensity of post-operative visits. In response to our request for comments on methods of obtaining accurate and current data on E/M services furnished as part of a globa l surgical package, some commenters stated that they believe post-operative work is appropriate ly surveyed, vetted and valued by the AMA RUC during its ongoing reviews of surg ical procedures, and therefore, claims-based reporting is unnecessary in order to verify that the number of visits assigned to global surgical procedures is accurate. Some commenters stated that if CMS has concerns with a specific code, or group of codes, regarding the number of E/M visits valu ed within the physician work RVU, CMS should work with the AMA RUC to review these serv ices. One commenter noted that there are 4,258 CPT codes on the PFS with a global period, but that only 271 of these CPT codes are billed more than 10,000 times annually, and most of the 271 CPT codes have been reviewed by CMS and the AMA RUC since 2005. Response: We thank the commenters for thei r recommendations on this important issue. We will carefully weigh all comments rece ived as we consider how best to measure the number and level of visits that occur during th e global period. In addition to the broader comments on measuring post-operative work, we also received a comment from the AMA RUC noting that the hospital and discharge management services included in the global pe riod for many surgical procedures may have been inadvertently removed from the time file in 2007. With its co mment letter, the AMA RUC sent us a revised70 time file with updated post-operative visits for the services that may be incorrectly displayed with zero visits. We are reviewing this f ile, and if appropriate, we intend to propose modifications to the physician time file in th e CY 2014 PFS proposed rule. We note that should time have been removed from the physician time f ile inadvertently, it would not have affected the physician work RVUs or direct practice expense inputs for thes e services. It would have a small impact on the indirect allocation of practic e expense at the specialty level, which we will review when we explore this potential time file change. 3. CY 2013 Identification and Review of Potentially Misvalued Services a. Public Nomination of Po tentially Misvalued Codes In the CY 2012 PFS final rule, we finalized a public nomination pr ocess for potentially misvalued codes (76 FR 73058). Under the previ ous Five-Year Reviews for PE and work, we invited the public to nominate potentially misval ued codes for review. To allow for public input and to preserve the public’s ability to identify and nominate potentially misvalued codes for review under our annual potential ly misvalued codes initiative , we established a process by which the public can submit codes, along with documentation supporting the need for review, on an annual basis. Stakeholders may nomina te potentially misvalued codes for review by submitting the code with supporting documentati on during the 60-day public comment period following the release of the annual PFS fi nal rule with comment period. Supporting documentation for codes nominated for the annual review of potentially misvalued codes may include the following:

● Documentation in the peer reviewed medical literature or other reli able data that there have been changes in physician work due to one or more of the following: technique; knowledge and technology; patient population; site-of-service; length of hos pital stay; and physician time.

● Evidence of an anomalous relationship between the code being proposed for review and other codes.71

● Evidence that technology ha s changed physician work, that is, diffusion of technology.

● Analysis of other data on time and effort measures, such as operating room logs or national and other representative databases.

● Evidence that incorrect assumptions were made in the previous valuation of the service, such as a misleading vignette, survey, or flawed crosswalk assumptions in a previous evaluation.

● Prices for certain high cost supplies or othe r direct PE inputs that are used to determine PE RVUs are inaccurate and do not reflect current information.

● Analyses of physician time, work RVU, or direct PE inputs using other data sources (for example, Department of Veteran Affair s (VA) National Surgical Quality Improvement Program (NSQIP), the Society for Thoracic Su rgeons (STS), and th e Physician Quality Reporting System (PQRS) databases).

● National surveys of physician time and in tensity from professional and management societies and organizations, su ch as hospital associations. Under this newly established process, afte r we receive the nomi nated codes during the 60-day comment period following the release of th e annual PFS final rule with comment period, we evaluate the supporting documentation and asse ss whether the submitted codes appear to be potentially misvalued codes appr opriate for review under the annua l process. In the following year’s PFS proposed rule, we publish the list of nominated codes, and propose -which nominated codes will be reviewed as potentially mi svalued. We encourage the public to submit nominations for potentially misvalued codes in the 60-day comment period following the publication of this CY 2013 PFS fina l rule with comment period.

TABLE 4: CPT Codes Nominated as Pote ntially Misvalued for CY 2013 Rulemaking

CPT Code Short Descriptor CMS Action72

CPT Code Short Descriptor CMS Action
33282 Implant pat-active ht record Establish nonfacility inputs, and review the work, facility and nonfacility inputs together. Not co nsidered a potentially misvalued code. 33284 Remove pat-active ht record Establish nonfacility inputs, and review the work, facility and nonfacility inputs together. Not co nsidered a potentially misvalued code. 36819 Av fuse uppr arm basilic Review as a potentially misvalued code. 36825 Artery-vein autograft Review as a potentially misvalued code. 53445 Insert uro/ves nck sphincter Interim Final in CY 2012, Final for CY 2013. Comments addressed in section II.M.2.a.of this CY 2013 PFS final rule with comment period. 77336 Radiation physics consult Review as a potentially misvalued code. 94762 Measure blood oxygen level Adopt direct PE revisions discussed below on an interim final basis for CY 2013. 28820 Amputation of toe Last reviewed for CY 2012. No further review required at this time. 28825 Partial amputation of toe Last reviewed for CY 2012. No further review required at this time. 35188 Repair blood vessel lesion Last reviewed for CY 2012. No further review required at this time. 35612 Artery bypass graft Last reviewed for CY 2012. No further review required at this time. 35800 Explore neck vessels Last reviewed for CY 2012. No further review required at this time. 35840 Explore abdominal vessels Last reviewed for CY 2012. No further review required at this time. 35860 Explore limb vessels Last reviewed for CY 2012. No further review required at this time. 43283 Lap esoph lengthening Last reviewed for CY 2012. No further review required at this time. 43327 Esoph fundoplasty lap Last reviewed for CY 2012. No further review required at this time. 43328 Esoph fundoplasty thor Last reviewed for CY 2012. No further review required at this time. 43332 Transab esoph hiat hern rpr Last reviewed for CY 2012. No further review required at this time. 43333 Transab esoph hiat hern rpr Last reviewed for CY 2012. No further review required at this time. 43334 Transthor diaphrag hern rpr Last reviewed for CY 2012. No further review required at this time. 43335 Transthor diaphrag hern rpr Last reviewed for CY 2012. No further review required at this time. 43336 Thorabd diaphr hern repair Last reviewed for CY 2012. No further review required at this time. 43337 Thorabd diaphr hern repair Last reviewed for CY 2012. No further review required at this time. 43338 Esoph lengthening Last reviewed for CY 2012. No further review required at this time. 47563 Laparo cholecystectomy/graph Last reviewed for CY 2012. No further review required at this time. 49507 Prp i/hern init block >5 yr Last reviewed for CY 2012. No further review required at this time. 49521 Rerepair ing hernia blocked Last reviewed for CY 2012. No further review required at this time. 49587 Rpr umbil hern block > 5 yr Last reviewed for CY 2012. No further review required at this time. 49652 Lap vent/abd hernia repair Last reviewed for CY 2012. No further review required at this time. 49653 Lap vent/abd hern proc comp Last reviewed for CY 2012. No further review required at this time. 49654 Lap inc hernia repair Last reviewed for CY 2012. No further review required at this time. 49655 Lap inc hern repair comp Last reviewed for CY 2012. No further review required at this time. 60220 Partial removal of thyroid Last reviewed for CY 2012. No further review required at this time. 60240 Removal of thyroid Last reviewed for CY 2012. No further review required at this time. 60500 Explore parathyroid glands Last reviewed for CY 2012. No further review required at this time. 95800 Slp stdy unattended Last reviewed for CY 2012. No further review required at this time.
In the 60 days following the re lease of the CY 2012 PFS fina l rule with comment period, we received nominations and suppor ting documentation for review of the codes listed above in Table 4. A total of 36 CPT codes were nominate d. The majority of the nominated codes were73
codes for which we finalized RVUs in the CY 2012 PFS final rule. That is, the RVUs were interim in CY 2011 and finalized for CY 2012, or proposed in either the Fourth Five-Year Review of Work or the CY 2012 PFS proposed ru le and finalized for CY 2012. In the CY 2013 proposed rule, we noted that under this annual public nomination proce ss it would be highly unlikely that we would determine that a nominat ed code is appropriate for review under the potentially misvalued codes initia tive if it had been reviewed in the years immediately preceding its nomination since we believe that the best in formation on the level of physician work and PE inputs already would have been available thr ough that recent review. We stated that, nonetheless, we would evaluate the supporting documentation for each nominated code to ascertain whether the submitted information demonstr ated that the code is potentially misvalued. CPT codes 33282 (Implantation of patient-ac tivated cardiac event recorder) and 33284 (Removal of an implantable, patient-activated ca rdiac event recorder) were nominated for review as potentially misvalued codes. The requestor stated that CPT codes 33282 and 33284 are misvalued in the nonfacility setti ng because these CPT codes currently are only priced in the facility setting even though physic ians furnish these services in the office setting. The requestor asked that we establish appropriate payment for the services when furnished in a physician’s office. Specifically, the requestor asked that CMS establish nonfacility PE RVUs for these services. In the CY 2013 proposed ru le, we stated that we do not cons ider the lack of pricing in a particular setting as an indicator of a potentially misvalued code . However, given that these services are now furnished in the nonfacility setting, we believe that CPT codes 33282 and 33284 should be reviewed to establish appropriate nonfacility inputs. We noted, as did the requestor, that the valuation of a service under the PFS in a part icular setting does not address whether those services and the setting in which they are furnished are medically reasonable and necessary for a patient’s medical needs and c ondition. We proposed to review CPT codes 33282 and 33284 and requested recommendations from the AMA RUC and other public commenters74 on the appropriate physician work RVUs (as meas ured by time and intensity), and facility and nonfacility direct PE inputs for these services. Like CPT codes 33282 and 33284, stakeholders re quested that we establish appropriate payment for CPT code 63650 (Percutaneous implan tation of neurostimula tor electrode array, epidural) when furnished in an office setting. In the CY 2013 proposed rule, we noted that this request was not submitted as a potentially misv alued code nomination. However, given that these services are now furnished in the nonfacility setting, we stated that we believed CPT code 63650 should be reviewed to establish appropriate nonfacility inputs. Please see section III.A.3 (Changes to Direct Inputs for Speci fic Services) for a discussion of spinal code stimulation trial procedures in the nonfacility setting. The following is a summary of the comments we received in response to our proposal to review the physician work, f acility, and nonfacility direct PE inputs for CPT codes 33282 and
33284.
Comment : Several commenters did not support our proposal to review CPT codes 33282 and 33284. Commenters stated that the very low utilization in the nonfac ility setting does not justify a review of the codes fo r nonfacility PE inputs. One comm enter noted that physicians are not interested in furnishing these services in th e nonfacility setting due to concerns for patient safety. Commenters recommended that we not consider establishing nonfacility PE RVUs for these CPT codes until additional studies indicate a clinical need to furnish these services in the nonfacility setting. Additionally, commenters stated that they do not believe it is necessary to review physician work and PE in the facility setting, as that was not the co ncern that the stakeholder brought forward. The AMA RUC stated that it continues to support the current work RVUs and facility PE inputs for these services. Another commenter recommende d that CMS finalize the proposal to revalue CPT codes 33282 and 33284 in order to establish nonfacility PE RVUs. The comme nter stated that the lack75 of nonfacility PE RVUs prevents physicians from furnishing these services in the office for select patients for whom this setting of care is safe and appropriate. This commenter recommended that CMS maintain the existing work RVUs, and focus the revaluation on the nonfacility PE inputs. The comment er requested that CMS remain flexible in its approach to nominated codes and allow for mo re expeditious review of code s by not requiring full provider
surveys. Response : After reviewing the comments receive d, we are finalizing our proposal to review the physician work, and facility and nonf acility direct PE inputs for CPT codes 33282 and 33284. We acknowledge that we rece ived very few Medicare claims for these services in the nonfacility setting in CY 2011; nonetheless, we belie ve it is appropriate to consider the relative resources involved in furnishing th is service in the nonfacility se tting. We reiterate that the valuation of a service under th e PFS in a particular setting do es not address whether those services and the setting in which they are furnis hed are medically reasonable and necessary for a patient’s medical needs and condition. We acknowledge that commenters support the cu rrent work and facility RVUs, however, it is our policy generally to revi ew the physician work, facility, and nonfacility direct PE inputs for each service together to ensure consistency in the inputs used to value the service. Based on information provided by the requestor and the 20 11 nonfacility utilization for this code, we believe it is appropriate to review this service for nonfacility PE inputs. As explained above, we intend to review the work and facility inputs as well. Additionally, we note that the physician work and facility PE inputs for these two services have not been reviewed in over a decade, so we believe it is reasonable to assess whether the inputs on which the cu rrent payment rates are based accurately reflect the resources involved in furnishing these services today. Accordingly, we are finalizing our proposal to review the physician work, and facility and nonfacility direct practice expense inputs for CPT codes 33282 and 33284, and request comments on the76 appropriate physician work, and f acility and nonfacility di rect practice expense inputs for these services. Traditionally, we have received reco mmendations from the AMA RUC on the appropriate physician work, PE, a nd malpractice inputs for services CMS plans to review and revalue. However, we understand that the AMA RUC may not issue recommendations for all codes under review by CMS. In addition to requesting recommendations from the AMA RUC on services we intend to review , we request and encourage reco mmendations on these services from other public commenters as well. We ac knowledge the requestor’s comment that CMS remain flexible in its approach to nominated codes and not require full practitioner surveys for CPT codes 33282 and 33284. We understand that practitioner survey s regarding work, malpractice, and PE are not always available, practical, or reliable. We encourage commenters to submit the best data available on the appropr iate valuation and input s for the services under review, including the information listed a bove under supporting documentation for the nomination of potentially misvalued codes. In the CY 2013 proposed rule, we stated that we did not consider CPT codes 36819 (Arteriovenous anastomosis, open; by upper arm basilic vein transposition) and 36825 (Creation of arteriovenous fistula by other than direct arteriovenous anas tomosis (separate procedure); autogenous graft) to be potentially misvalued becau se these codes were last reviewed and valued for CY 2012 and the supporting documentati on did not provide sufficient evidence to demonstrate that the codes should be review ed as potentially misvalued for CY 2013 or CY 2014. The following is a summary of the commen ts we received in response to our proposal not to review CPT codes 36819 and 36825 as potentially misvalued codes.
Comment: One commenter reiterated its belief that CPT codes 36819 and 36825 are potentially misvalued because the work RVUs finalized by CMS in CY 2012 place these services out of rank order with services that involve si milar resources. To support this position, the77 commenter provided a list showing these services relative to all services with a similar global period, intra-service time, and work RVU. The commenter also rest ated the rationale previously submitted to CMS when it nominated these services as potentially misvalued. The commenter requested that CMS reconsider the work RVUs of these two services. Response: After reviewing the comments received and conducting a clinical review of CPT codes 36819 and 36825 alongside similar services, we agree with the commenter that these services may be out of rank orde r and are potentially misvalued. Therefore, we are modifying our proposal to not review CPT codes 36819 and 36825 as potentially misval ued codes. We will review CPT codes 36819 and 36825 along with their code families, which include CPT codes 36818 through 36821 and CPT codes 36825 through 36830, as potentially misvalued. We thank commenters for the additional supporting docu mentation provided, and request additional comments on the appropriate physician work and direct PE inputs for these services. CPT code 53445 (Insertion of inflatable uret hral/bladder neck sphincter, including placement of pump, reservoir, and cuff) was no minated for review as a potentially misvalued code. CPT code 53445 was identified through the site-of-service anomal y potentially misvalued code screen for CY 2008. We co mpleted our review and establis hed RVUs for this code on an interim basis for CY 2012 subject to public comme nt. In the CY 2013 proposed rule, we stated that we would consider the supporting documen tation submitted under the potentially misvalued code nomination process for CPT code 53445 as comments on the CY 2012 interim final value, and would address the comments in the CY 2013 PFS final rule with comment period when we address the final value of the CPT code. A summary of the comments received on CPT code 53445 and our response to those comments is included in section II.M.2 of this final rule with comment period. CPT code 77336 (Continuing medical physics consultation, includ ing assessment of treatment parameters, quality assurance of dose delivery, and review of patient treatment78 documentation in support of the radiation oncol ogist, reported per w eek of therapy) was nominated for review as a potentially misvalued code. The requestor st ated that CPT code 77336 is misvalued because changes in the technique for furnishing continuing medical physics consultations have resulted in changes to the knowledge required, time, and effort expended, and complexity of technology associat ed with the tasks performed by the physicist and other staff. Additionally the requestor stated that the di rect PE inputs no longer accurately reflect the resources used to deliver this service and may be undervalued. CPT code 77336 was last reviewed for CY 2003. In the CY 2013 proposed rule, we stated that after evaluating the detailed supporting information that the commen ter provided, we believed there may have been changes in technology and other PE inputs since we last reviewed the service, and that further review is warranted. As such, we proposed to review CPT code 77336 as potentially misvalued and requested recommendations from the AMA RU C and other public commenters on the direct PE inputs for this service and for the other serv ices within this family of CPT codes. The following is a summary of the comments we received in response to our proposal to review CPT code 77336 as potentially misvalued.
Comment: Commenters supported the CMS pr oposal to review CPT code 77336 and urged CMS to finalize it. The AMA RUC stated that it would re view this service and provide recommendations to CMS on its valuation. Several commenters reiterated their rationale for why they believe CPT code 77336 is potentially misval ued and provided supporting documentation. Additionally, commenters indicated that the Amer ican Society for Physicists in Medicine (AAPM) would submit information on practice expe nse inputs and other data to support the revaluation of this CPT code, and expressed appr eciation that CMS is will ing to consider data and input from professional medical societies that do not participat e in the AMA RUC process. Response: After reviewing the comments received, we continue to believe that changes in technology may have altered the direct practice expense inputs associated with CPT code 7733679 and are finalizing our proposal to review this service as pote ntially misvalued. We thank commenters for the supporting documentation pr ovided, and request addi tional comments on the appropriate direct PE inputs for this service, as well as any other se rvices that may be within this family of CPT codes. CPT code 94762 (Noninvasive ear or pulse oximetry for oxygen saturation; by continuous overnight monitoring (separate procedur e)) was nominated for review as a potentially misvalued code. Requestors stated that CPT c ode 94762 is misvalued because the time currently allocated to the various direct PE inputs does no t accurately reflect curren t practice. Requestors also stated that independent dia gnostic testing f acilities are not appropriate ly accounted for in the current indirect PE methodology. In the CY 2013 pr oposed rule, we stated that, in response to these stakeholder concerns, we reviewed th e PE inputs for CPT code 94762, which was last reviewed for CY 2010. We believed that CP T code 94762 is misvalued, and we proposed changes to the PE inputs for CY 2013. We stat ed that, following clinical review, we believed that the current time allocated to clinical labor and supplies appropr iately reflects current practice. However, we believed that 480 minut es (8 hours) of equipment time for the pulse oximetry recording slot and pulse oximeter with pr inter are more appropriate for this overnight monitoring procedure code. As such, we proposed this refinement to the direct PE inputs for CPT code 94762 for CY 2013. These proposed adjustments were reflected in the CY 2013 proposed direct PE input database, available on the CMS website under the downloads for the CY 2013 PFS final rule with comment period at http://www.cms.gov/PhysicianFeeSched/

. The following is a summary of the comments received regarding the proposed direct PE adjustments to CPT code 94762.
Comment : Many commenters agreed with CMS’ proposal to refine the equipment minutes for this service to 480 minutes. One co mmenter suggested that CMS should increase the proposed allocation of minutes to account for the time that the equipment is unavailable for use80 because the patient has yet to return it to the office. Response : We appreciate the support for the propos al. We believe that the appropriate allocation of minutes for the equipment is the su m of the times within the intra-service period when a clinician is using the piece of equipment, plus any additional time the piece of equipment is not available for use for another patient due to its use during the designated procedure. However, we also note that the equipment cost per minute calculation inco rporates a utilization rate assumption that appropriately accounts for th e time the equipment cannot be used because it is being transported to and from the office or be tween patients. Therefor e, we are not revising our proposed adjustment to the equipment time.
Comment : Several commenters supported the pr oposed allocation of minutes to the equipment and also submitted invoices and other evidence for updating the direct PE inputs for the service. The AMA RUC and others submitted information to update the pulse oximeter and the recording software used in the service. The information submitted by the AMA RUC reflects a pulse oximeter priced at $1418 and recording software priced at $990. Other commenters submitted various disposable supplies that might be used to furnish the service, including varying types of batteri es, oximeter cables, and wristba nds that might be used when furnishing this service. Response : We appreciate the updated information furnished to us by stakeholders and other commenters. While we generally urge st akeholders to submit su ch price update requests through the process for updating supply and equipment prices we established for CY 2011, because we made a proposal spec ifically related to the equipm ent minutes allocated for this procedure, we believe it woul d be appropriate to consider the supplies and equipment price inputs associated with the service in conjuncti on with the proposal to change the equipment minutes. Based on the invoice information we r eceived from commenters, we will update the price of the ‘pulse oximetry r ecording software (prolonged mon itoring)’ (EQ212) and include a81 new equipment item “Pulse Oximeter 920 M Plus ” priced at $1,418 as equipment inputs for the code. In reviewing the requested supply items to include, we believe that it would be appropriate to include 6 AA batteries (SK095) as a disposable supply for the se rvice as well as incorporate a new item, a disposable oximeter cable, priced at $11.08. Based on these comments and our clinical revi ew, we are adopting these direct PE inputs, including our adjusted allocati on of equipment minutes, on an interim basis for CY 2013. These values are reflected in the CY 2013 PFS direct PE input database available under downloads for the CY 2013 PFS final rule with comment period on the CMS Web site at: http://www.cms.gov/PhysicianFeeSched/PFSFRN/list.asp#TopOfPage . We also note that the PE RVUs included in Addenda B and C reflect these interim direct PE inputs. In the CY 2013 proposed rule, we stated that we did not consider the nomin ated codes that were last reviewed and valued for CY 2012 to be potentially misvalued because the supporting documentation did not provide sufficient evidence to demonstrate that the codes should be reviewed as potentially misvalued for CY 2013 or CY 2014. The supporting documentation for these services generally mirrored the public comments previously submitted, to which CMS has already responded. Below is a summary of the comments we received in response to our proposal to not review the CPT codes liste d above in Table 4 not discussed above.
Comment: We received a few limited comments on the nominated codes not previously discussed above, however, lik e the code nominations, the comments and supporting documentation for these services mirrored the public comments previously submitted, to which CMS has already responded. Response: Having received no new information on the CPT codes listed in Table 4 not previously discussed, we are fina lizing our proposal not to review those services as potentially misvalued. b. Potentially Misvalued Code Lists82
As mentioned above, in the last several a nnual PFS proposed rules we have identified lists of potentially misvalued codes for review. We believe it is imperative that we continue to identify new lists of potentially misvalued codes for review to appropriately identify, review, and adjust values for potentially misvalued codes for CY 2013. (1) Review of Harvard-Valued Services with Medicare Allowed Charges of $10,000,000 or
More For many years, we have been reviewing ‘Harvard-valued’ CPT codes through the potentially misvalued code initia tive. The RVUs for Harvard-valued CPT codes have not been reviewed since they were originally valued in the early 1990s at the begi nning of the PFS. While the principles underlying the relative value sc ale have not changed, over time the methodologies we use for valuing services on the PFS have changed, potentially disrupting the relativity between the remaining Harvard-valued codes and other codes on the PFS. At this time, nearly all CPT codes that were Harvard-valued and had Medicare utilizati on of over 30,000 allowed services per year have been reviewed. In the CY 2013 PFS proposed rule, we proposed to review Harvard-valued services with annual Medicare allowed char ges of $10 million or greater. The CPT codes meeting these criteria have re latively low Medicare util ization (as we have reviewed the services with utilization over 30,000) , but account for significant Medicare spending annually and have never been reviewed. In the CY 2013 proposed rule, we noted that several of the CPT codes meeting these criteria have already been id entified as potentially misvalued through other screens and were sc heduled for review for CY 2013. We also recognized that other codes meeting these crit eria had been referred by the AMA RUC to the CPT Editorial Panel. We stated that, in thes e cases, we were not propos ing re-review of these already identified services , but for the sake of completeness, we included those codes as a part of this category of potentially misval ued services. In our proposal, we recognized that the relatively low Medicare utilization for these services ma y make gathering information on the appropriate83 physician work and direct PE inputs difficult. We requested recommendations from the AMA RUC and other public commenters, and stated th at we appreciate effort s expended to provide RVU and input recommendations to CMS for thes e lower volume services. Because survey sample sizes could be small for these lower volum e services, we encouraged the use of valid and reliable alternative data sources and methodol ogies when developing recommended values. In sum, we proposed to review Harvard-valued CPT codes with annual allowed charges of $10 million or more as a part of the potentially mi svalued codes initiative. In the CY 2013 proposed rule, we stated that the following codes met the cr iteria for this screen and proposed to review these CPT codes as potentially misvalued services. TABLE 5: Proposed Harvard-valued CP T Codes with Annual Allowed Charges ≥ $10,000,000 CPT Code Short Descriptor 13152* Repair of wound or lesion 27446 Revision of knee joint 29823 Shoulder arthroscopy/surgery 36215** Place catheter in artery 36245** Ins cath abd/l-ext art 1st 43264** Endo cholangiopancreatograph 50360 Transplantation of kidney 52353* Cystouretero w/lithotripsy 64450* N block other peripheral 64590 Insrt/redo pn/gastr stimul 66180 Implant eye shunt 67036 Removal of inner eye fluid 67917 Repair eyelid defect 92286** Internal eye photography 92982* Coronary artery dilation 95860* Muscle test one limb *Scheduled for CY 2012 AMA RUC Review **Referred by the AMA RUC to the CPT Editorial Panel
The following is summary of the comments we received in response to our proposal to review Harvard-valued CPT codes with annual a llowed charges of $10 million or more as a part of the potentially misval ued codes initiative.84

Comment : Comments on this proposal were spec ific to the CPT codes we proposed to review under this potentially misvalued code sc reen. A few commenters noted that CPT code 64590 (Insertion or replacement of peripheral or gastric neuros timulator pulse generator or receiver, direct or inductive coupling) does not have annual allowed charges that meet the threshold of $10 million and stated that the c ode should be removed from the list. These commenters requested that CMS reexamine this li st to ensure all codes meet the specified criteria. Other commenters pointed out that certa in codes on the list are already scheduled for review by the medical specialty societies and the AMA RUC, and that some codes are scheduled for deletion by the CPT Editorial Panel. The AMA RUC stated that it woul d discuss the list of codes that meet the criteria for this screen and would determine the next steps in the AMA RUC’s review of these services. Response : After reviewing the comments received, and reexamining the Medicare claims data, we agree with commenters that CPT c ode 64590 does not have annual Medicare allowed charges of $10 million or greater, nor do CP T codes 29823 (Arthroscopy, shoulder, surgical; debridement, extensive) and 95860 (Needle elect romyography; 1 extremity with or without related paraspinal areas). In compiling the li st, we inadvertently included allowed charges incurred in the ambulatory surgical center setting. We thank comme nters for bringing this to our attention. Therefore, we have re moved these three services from the proposed list of CPT codes that are Harvard-value with annual allo wed charges of $10 million or greater. In the CY 2013 proposed rule, we noted that several codes that met the criteria for this potentially misvalued code screen were curren tly under review for CY 2013 and others were scheduled for review by the CPT Editorial Pane l. CPT codes 13152 (Repair, complex, eyelids, nose, ears and/or lips; 2.6 cm to 7.5 cm), 52353 (Cystourethroscopy, with ureteroscopy and/or pyeloscopy; with lithotri psy (ureteral catheterization is in cluded)), 64450 (Inject ion, anesthetic agent; other peripheral nerve or branch), 92286 (Special anterior segment photography with85 interpretation and report; w ith specular endothelial micros copy and cell count), and 95860 (Needle electromyography; 1 extremity with or wit hout related paraspinal areas) were reviewed for CY 2013. A discussion of the interim final valu es for those services is in section III.M.3. of this final rule with comment period. CPT c ode 92982 (Percutaneous transluminal coronary balloon angioplasty; single vesse l) has been deleted by the CPT Editorial Panel for CY 2013. We have updated the list of CPT codes meeting th is potentially misvalued code screen to show the review status of the codes, and to remove the three CPT codes mentioned above that do not meet the parameters of the screen. We are fina lizing the list of Harvard-valued CPT codes with annual allowed charges of $10 million or more in Table 6, and for CY 2014, we will review the services not already reviewed. We request pub lic comments on the appropriate work RVUs and direct practice expense input s for these services.
TABLE 6: Harvard-valued CPT Co des with Annual Allowed Charges ≥ $10,000,000 CPT Code Short Descriptor Review Status 13152 Repair of wound or lesion Interim Final for CY 2013 27446 Revision of knee joint Review for CY 2014 36215 Place catheter in artery Review for CY 2014 36245 Ins cath abd/l-ext art 1 st Review for CY 2014 43264 Endo cholangiopancreatograph Review for CY 2014 50360 Transplantation of kidney Review for CY 2014 52353 Cystouretero w/lithotripsy Interim Final for CY 2013 64450 N block other peripheral Interim Final for CY 2013 66180 Implant eye shunt Review for CY 2014 67036 Removal of inner eye fluid Review for CY 2014 67917 Repair eyelid defect Review for CY 2014 92286 Internal eye photography Interim Final for CY 2013 92982 Coronary artery dilation Deleted for CY 2013

(2) Review of Services with St and Alone PE Procedure Time Improving the accuracy of procedure time assu mptions used in PFS ratesetting continues to be a high priority of the poten tially misvalued codes initiative. Procedure time is a critical measure of the resources typica lly used in furnishing partic ular services to Medicare86 beneficiaries, and procedure time assumptions are an important component in the development of work and PE RVUs. Discussions in the a cademic community have indicated that certain procedure times used for PFS ratesetting are overst ated (McCall, N., J. Cromwell, et al. (2006). “Validation of physician survey es timates of surgical time using operating room logs.” Med Care
Res Rev 63(6): 764-777. Cromwell, J., S. Hoover, et al. (2006). “Validating CPT typical times for Medicare office evaluation and manageme nt (E/M) services.” Med Care Res Rev 63(2): 236- 255. Cromwell, J., N. McCall, et al. (2010). “Missing productivity gains in the Medicare physician fee schedule: where are they?” Med Care Res Rev 67(6): 236-255.) MedPAC and others have emphasized the importance of using th e best available procedure time information in establishing accurate PFS payment rates. (M edPAC, Report to the Congress: Aligning Incentives in Medicare, June 2010, p. 230) In recent years, CMS and the AMA RUC have taken steps to consider the accuracy of available data regarding procedur e times used in the valuation of the physician work component of PFS payment. Generally, the AMA RUC derives estimates of physician work time from survey responses, and the AMA RUC reviews and an alyzes those responses as part of its process for developing a recommendation for physician wo rk. These procedure time assumptions are also used in determining the appr opriate direct PE input values used in developing nonfacility PE RVUs. Specifically, physician intra-service time serves as the basis for allocating the appropriate number of minutes within the se rvice period to account for the time used in furnishing the service to the patient. The number of intra-service minutes, or occasionally a particular proportion thereof, is allocated to both the clinical staff that assists the physician in furnishing the service and to the equipment used by either the physician or the staff in furnishing the service. This allocation reflects only the time the beneficiary receive s treatment and does not include resources used immediatel y prior to or following the serv ice. Additional minutes are often allocated to both clinical labor and equipm ent resources in order to account for the time87 used for necessary preparatory tasks immediat ely preceding the procedure or tasks typically performed immediately following it. For codes without physician work, the procedure times assigned to the direct PE inputs for such codes assume that the clinic al labor performs the procedure. For these codes, the number of intr a-service minutes assigned to clinical staff is independent and not based on any physician intra- service time assumptions. Consequently, the procedure time assumptions for these kinds of serv ices have not been subject to all of the same mechanisms recently used by the AMA RUC and physician community in providing recommendations to CMS, and by CMS in the va luation of the physician work component of PFS payment. These independent clinical labor time assumptions largely determine the RVUs for the procedure. To ensure that procedure time assumptions are as accurate as possible across the Medicare PFS, we believe that codes withou t physician work should be examined with the same degree of scrutiny as serv ices with physician work. For CY 2012, a series of radiation treatment services were reviewed as part of the potentially misvalued code ini tiative. Among these were intens ity modulated radiation therapy (IMRT) delivery services and stereotactic body radiation therapy (SBRT) delivery services reported with CPT codes 77418 (Intensity modulat ed treatment delivery, single or multiple fields/arcs, via narrow spatially and tempora lly modulated beams, binary, dynamic MLC, per treatment session) and 77373 (Stereotactic body radiation therapy, tr eatment delivery, per fraction to 1 or more lesions, including image guid ance, entire course not to exceed 5 fractions), respectively. CPT code 77418 (IMRT treatment de livery) had been identified as potentially misvalued based on Medicare utilization data that indicated both fast growth in utilization and frequent billing with other codes. We identified this code as potentially misvalued in the CY 2009 PFS proposed rule (73 FR 38586). CPT code 77373 (SBRT treatment delivery) had been identified as potentially misvalued by the RUC as a recently established c ode describing services that use new technologies. Ther e is no physician work associated with either of these codes88 since other codes are used to bill for planning, dosimetry, and radiation guidance. Both codes are billed per treatment session. Because the physici an work associated with these treatments is reported using codes distinct from the treatmen t delivery, the primary determinant of PE RVUs for these codes is the number of minutes allocated for the procedure time to both the clinical labor (radiation therapist) and the resource-intensive capital equi pment included as direct PE inputs. In the CY 2012 PFS final rule with comment period, we received and accepted without refinement PE recommendations from the AMA RUC for these two codes. (We received the recommendation for CPT code 77418 (IMRT treatment delivery) too late in 2010 to be evaluated for CY 2011 and it was therefore included in the CY 2012 rulemaking cycle.) The AMA RUC recommended minor revisions to the direct PE inputs for the code to eliminate duplicative clinical labor, supplies, and e quipment to account for the freq uency with which the code was billed with other codes. For CPT code 77373 (SBRT treatment delivery), the RUC recommended no significant changes to the direct PE inputs. Subsequent to the publication of th e final rule, the AMA RUC and other stakeholders informed CMS that the direct PE input recommendation forwarded to CMS for IMRT treatment delivery (CPT code 77418) inadvertently omitted seven equipment items typically used in furnis hing the service. These items had been used as direct PE inputs for the code prior to CY 2012. There is broad agreement among stakeholders that these seven equipment items are typically used in furnishing the services described by CPT code 77418. We were unable to reinco rporate the items for CY 2012. These omitted items are listed in Table 7. In consideration of the comments from the AMA RUC and other stakeholders, we proposed to include the seven equipment items omitted from the RUC recommendation for CPT code 77418. These proposed adjustments were reflected in the CY 2013 proposed direct PE input database, available on the CMS89

website under the downloads for the CY 2013 PF S proposed rule with comment period at http://www.cms.gov/PhysicianFeeSched/

. We note that the proposed PE RVUs included in Addendum B reflected the proposed updates. TABLE 7: Equipment Inputs Omitted Fr om RUC Recommendation for CPT Code 77418 (IMRT Treatment Delivery) Equipment Code Equipment Description ED011 computer system, record and verify ED035 video camera ED036 video printer, colo r (Sony medical grade) EQ139 intercom (incl. master, pt substation, power, wiring) ER006 IMRT physics tools ER038 isocentric beam alignment device ER040 laser, diode, for patient positioning (Probe)

It has come to our attention that there ar e discrepancies between the procedure time assumptions used in establishing nonfacility PE RVUs for these services and the procedure times made widely available to Medica re beneficiaries and the general public. Specifically, the direct PE inputs for IMRT treatment delivery (CPT code 77418) reflect a procedure time assumption of 60 minutes. These procedure minutes were firs t assigned to the code for CY 2002 based on a recommendation from the AMA RUC indicating that the typical treatment time for the IMRT patient was 40 to 70 minutes. The most recent RUC recommendation that CMS received for CY 2012 rulemaking supported the procedure time assumption of 60 minutes. Information available to Medicare benefici aries and the general public indicates that IMRT sessions typically last between 10 and 30 mi nutes. For example, the American Society for Radiation Oncology (ASTRO) publishes a patient fact sheet that explains that for all external beam radiation therapy, including IMRT, “treatment is delivered in a series of daily sessions, each about 15 minutes long.” [“Radiation Therap y for Prostate Cancer: Facts to Help Patients Make an Informed Decision” available for purchase at www.astro.org/MyASTRO/Products/Product.aspx?AstroID=6901 .] This fact sheet is intended90 for patients with prostate cancer, the typical diagnosis for Medicare beneficiaries receiving IMRT. Similarly, the American College of Ra diology (ACR) and the Radiological Society of North America (RSNA) co-sponsor a website for patients called http://radiologyinfo.org that states that IMRT “treatment sessions us ually take between 10 and 30 minutes.” The direct PE inputs for SBRT treatment de livery (CPT code 77373) reflect a procedure time assumption of 90 minutes. These procedure mi nutes were first assign ed to the code for CY 2007 based on a recommendation from the AMA RUC. The most recent RUC recommendation that CMS received for CY 2012 rulemaking supported continuing that procedure time assumption. In 2012, information available to Medicare bene ficiaries and the genera l public states that SBRT treatment typically lasts no longer than 60 minutes. For example, the American College of Radiology (ACR) and the Radiological So ciety of North America (RSNA) website, http://radiologyinfo.org , states that SBRT “treatment can take up to one hour.” Given the importance of the procedure time assumption in the development of RVUs for these services, using the best available information is critical to ensuring that these services are valued appropriately. We believe medical societies and practitioners strive to offer their cancer patients accurate information regarding the IMRT or SBRT treatment experience. Therefore, we believe that the typical procedure time for IMRT delivery is between 10 and 30 minutes and that the typical procedure time for SBRT delivery is under 60 minutes. The se rvices are currently valued using procedure time assumptions of 60 and 90 minutes, respectively. We believe these procedure time assumptions, distinct from n ecessary preparatory or follow-up tasks by the clinical labor, are outd ated and need to be updated using th e best information available. While we generally have not used publicly available resources to establish procedure time assumptions, we believe that the procedure ti me assumptions used in setting payment rates for the Medicare PFS should be derived from the mo st accurate information available. In the91
case of these services, we believe that the ne ed to reconcile the di screpancies between our existing assumptions and more accurate informati on outweighs the potential value in maintaining relativity offered by only considering data from one source. We proposed to adjust the procedure time assumption for IMRT delivery (C PT code 77418) to 30 minutes. We proposed to adjust the procedure time assumption for SBRT delivery (CPT code 77373) to 60 minutes. These procedure time assumptions reflect the maxi mum number of minutes re ported as typical in publicly available information. We note that in the case of CPT code 77418, the ‘accelerator, 6-18 MV’ (ER010) and the ‘collimator, multileaf system w-autocrane’ (ER017) are used throughout the procedure and currently have no mi nutes allocated for preparing the equipment, positioning the patient, or cleaning the room. Since these clinical labor task s are associated with related codes typically reported at the same time, we also proposed to allocate minutes to these equipment items to account for their use immediatel y before and following th e procedure. All of these proposed adjustments are reflected in th e CY 2013 proposed direct PE input database, available on the CMS website under the downl oads for the CY 2013 PFS final rule with comment period at http://www.cms.gov/PhysicianFeeSched/ . We also note that the proposed PE RVUs included in Addendum B reflect the propos ed updates. We requested recommendations from the AMA RUC and other public commenters on the direct PE inputs for these services. While we recognize that using these procedur e time assumptions will result in payment reductions for these particular services, we beli eve such changes are necessary to appropriately value these services. Recent a ttention from popular media sources like the Wall Street Journal ( online.wsj.com/article/SB10001424052748703904804575631222900534954.html December 7,2010 ) and the Washington Post ( www.washingtonpost.com/wpdyn/content/article/2011/02/28/AR2011022805378.html ) February 28, 2011 has encouraged us to consider the possibility that potential overuse of IMRT services may be partially attributable to financial incentives resulting from inappropr iate payment rates. In its 2010 Report to92 Congress, MedPAC referenced concerns that financial incentives may influence how cancer patients are treated. In the context of the growth of ancillary services in physicians’ offices, MedPAC recommended that improving payment accu racy for discrete services should be a primary tool used by CMS to mitigate incentives to increase volume (Report to Congress: Aligning Incentives in Medicare, June 2010, p. 225). We note that in recent years, PFS nonfacility payment rates for IMRT treatment delive ry have exceeded the Medicare payment rate for the same service paid thr ough the hospital Outpatient Pros pective Payment System (OPPS), which includes packaged payment for image gui dance also used in treatment delivery. We believe that such high-volume services that are furnished in both nonfacility and facility settings are unlikely to be more resource-intensive in freestanding radiati on therapy centers or physicians’ offices than when furnished in facili ties like hospitals that generally incur higher overhead costs, maintain a 24 hour, 7 day per week capacity, are generally paid in larger bundles, and generally furnish services to higher acuity patients than the patients who receive services in physicians’ offices or freestanding clinics. Given that the OPPS payment rates are based on auditable data on hospital costs, we believe th e relationship between th e OPPS and nonfacility PFS payment rates reflects inappropriate assumptions within the current dir ect PE inputs for CPT code 77418. The AMA RUC’s most recent direct PE input recommendations reflect the same procedure time assumptions used in developi ng the recommendations for CY 2002. However, we believe that using procedure time assumptions that reflect the maximum times reported as typical to Medicare beneficiaries will improve the accuracy of those inputs and the resulting nonfacility payment rates. We received many comments regarding our pro posal to change the direct PE inputs for CPT codes 77418 and 77373 based on amended procedure time assumptions and consideration of the comments from the AMA RUC and other stakeholders to include the seven equipment items omitted from the previous AMA RUC recommendation for CPT code 77418. The93 following is summary of the comments we rece ived and our responses to those comments.
Comment : Several commenters agreed with CM S’ proposal to add the equipment items omitted from the AMA RUC recommendation for CPT code 77418 to the code. Response: We appreciate the support for that aspect of the proposal.
Comment: Many commenters disagreed with CMS’ proposal to adjust the procedure time assumptions for these services. Some of these commenters stated that 35 minutes was a more appropriate estimate, but none presented a lternative sources of objective information for determining accurate procedure time assumpti ons. Many commenters objected to CMS’ proposal on the basis that the agency used public ly available information to adjust procedure times assumptions instead of basing its propos al on information developed through the AMA RUC process. These commenters stated that CMS should not finalize its proposed procedure time assumptions for one of four reasons: publicly available procedure time information does not consider the time resources required prior to or following the procedure, that educational information for patients is an inappropriate data source because such material is not subject to the same degree of scrutiny by the medical commun ity as the information presented to the AMA RUC, that CMS only has the authority to review or revalue PFS services through the AMA RUC process, or that time has been universally infl ated by the AMA RUC so that using more accurate time assumptions in setting the RVUs for these serv ices would distor t their value relative to other PFS services. Response: We appreciate the commenters’ inte rest in CMS using the best available data to identify the time resources required to furnish se rvices to Medicare bene ficiaries. We address commenters’ objections to using these patient education materials in the comment summaries and response paragraphs that follow. Comment: Many commenters stated that pa tient education materials are not an appropriate source of data because the procedur e times conveyed through such materials may not94 fully account for the time spent positioning the patie nt for treatment, performing safety checks or the work that occurs before and after treatment. Several commenters explicitly stated that it is highly likely that the patient e ducation materials describe only th e time the patient is on the treatment table. . Response: We understand that the procedure tim es cited in the patient education materials may not include the full time for prep aring the equipment, positioning the patient or other necessary work required prior to or following the procedure. The procedure time assumptions used in developing direct PE input s only account for a portion of the service period minutes allocated to the clinical labor or the equipment direct PE inputs. For example, in our proposal to reduce procedure time assumptions for CPT code 77418, we allocated an additional seven minutes to the equipment beyond the procedure time assumption for additional tasks. These minutes reflect the standard minutes usually recommended by the RUC for these tasks. For example, for CY 2013 the AMA RUC recomme nded these minutes for direct PE inputs for CPT code 31231 (Nasal endoscopy, di agnostic, unilateral or bilate ral (separate pr ocedure), CPT code 52287 (Cystourethroscopy with injection(s) for chemodenervation of the bladder), CPT code 65800 (Paracentesis of anterior chamber of eye (separate procedur e); with diagnostic aspiration of aqueous), and CPT code 11311 (Sha ving of epidermal or dermal lesion, single lesion, face ears, eyelid, nose, lips, mucous me mbrane; lesion diameter 0.6 to 1.0 cm). We also note that the direct PE inputs fo r codes describing imaging guidance services that are typically reported at the same time include minutes for the radiation therapist to prepare the room, position the patient, and clean the room. Similarly, the proposed direct PE inputs for CPT code 77373 incorporate clinical labor and equipment minutes that exceed the minutes assumed for the procedure itself: 24 minutes of additional nurse time, 24 minutes of additional time for the radiation therapist, and 15 addi tional minutes for the medical physicist for preservice and post-service tasks. On the basis of these tasks, the equipment associated with the95 code has also been allocated 24 minutes beyond the procedure time assumption for pre-service and post-service work. Therefor e, we do not agree with comme nters who suggested that our proposed revisions are inappropriate because the procedure time re ported in the patient education materials may underestimate the procedure time assumptions used in developing direct PE inputs. Instead, we believe that the typical procedure time desc ribed in the patient education material is generally equivalent to the minutes incorporated in the service period for performing the procedure. We already have incorporated additional minutes of clinical labor time into the direct PE inputs for both CPT codes 77418 and 77373 to account for tasks like preparing the equipment and cleaning the room in addition to the minutes allocated for the procedure time assumptions. This reflects the direct PE input s used for most services, where we allocate minutes to clinical labor and medical equipment for preparatory or follow-up tasks in addition to the equipment time allocated based on the proc edure time assumption. While many commenters stated that the procedure times reported in th e publicly available in formation do not include necessary preparatory or follow-up tasks, we rece ived no comments with specific objections to the number of minutes allocated for such ta sks in conjunction w ith our proposal.
Comment: The AMA RUC and some medical speci alty societies expr essed opposition to CMS using patient education materials in the pro cess of setting Medicare payment rates. These commenters claimed that such information is not evaluated by the same standards applied to the extant data used as part of th e AMA RUC process, so that CMS’ use of these materials is illconceived. Response: As we stated previously, we believe medical societie s and practitioners strive to offer their cancer patients accurate information regarding the IMRT or SBRT treatment experience. We believe that such informati on, especially for high-volume services, is more likely to reflect typical treatment times than in formation proffered solely for the purpose of developing payment rates. While many commenters objected in principle to the validity of the96 patient education materials, we do not believe th at medical specialty societies and providers of care would broadly inform their patients that IMRT treatment would last between 10 and 30 minutes per session if the typical treatment sessi on actually lasted for one hour or that SBRT treatment would last for no more than one hour if it typically takes 90 minutes.
Comment: Many commenters claimed that CMS has the responsibility to conduct a comprehensive, empirical review of those pro cedure time assumptions utilizing the AMA RUC if CMS has concerns with those assumptions. Response: We agree that AMA RUC review an d recommendations are one important component in constructing payment rates under the physician fee schedule. While we do not agree with the commenters’ statement that CMS has a responsibility to conduct all reviews of potentially misvalued codes through the AMA RUC process exclusively, we note the AMA RUC reviewed both CPT codes 77418 and 77373 as recently as 2010. Both of these services had been identified under our potentially misvalued c ode initiative. As noted above, the AMA RUC recommended minor revisions to the direct PE inputs for the code to eliminate duplicative clinical labor, supplies, and e quipment to account for the freq uency with which the code was billed with other codes. For CPT code 77373 (SBRT treatment delivery), the AMA RUC recommended no significant changes to the direct PE inputs. We note that in response to this proposal, the AMA RUC has recently informed us that since there is no physician work associated with these codes, it has asked the re levant specialty society to conduct a survey for clinical staff time, in order to ensure accurate procedure times.
Comment: Some commenters stated that CMS should only consider the accuracy of these procedure time assumptions relative to the procedure time estimates for other services. Some of these commenters claimed that proce dure time assumptions for services across the PFS are inflated so that CMS should not use procedure time assumptions for these services that are also exaggerated.97
Response: We appreciate the commenters’ concerns with maintaining the relativity of time used in developing relative value units. We understand that procedure times may be overestimated for some other PFS services. While we agree that maintaining the resource relativity of services within the payment system is very important, we also believe that there is no practical means for CMS or stak eholders to engage in a comple te simultaneous review of time assumptions across all payable codes. As such, we must evaluate times (and other factors) and make adjustments in smaller increments when we find that adjustments are warranted. We strive to maintain relativity by reviewing all RVU comp onents for a code or revi ewing all codes within families where appropriate. Furthermore, we be lieve that our proposal to use more accurate procedure time assumptions for these services sh ould be considered in the context of broader efforts to improve the accuracy of PFS relative values, where time is a significant component of developing relative values. Since MedPAC’s March 2006 Report to the Congress, CMS has implemented a potentially misvalued codes initiative and has ta ken significant steps to identify and address potentially misvalued codes, including establishi ng physician times that accurately reflect the resources involved in furnishing the service. For example, CM S has reduced the physician times for services that were originally valued in th e inpatient setting but now are frequently performed in the outpatient setting, services that are frequently performed together or in multiple units, and services billed on the same day as an E/M servi ce. Furthermore, in ad dition to our proposal to review services with stand-alone procedure time, in this CY 2013 PFS final rule with comment period, we also discuss recommendations on how best to accurately measure post-operative work in the global surgical period, a nd finalize several proposals to ad just times for services with anomalous times in the physician time file. Mo reover, in September 2012, we entered into two contracts to assist us in valid ating RVUs of potentially misvalue d codes, which may include the validation of physician time elements.98 Additionally, we do not agree with the commen ters’ assertion that if time is distorted across the PFS, it is likely to be distorted with consistent proportionality. While the distortions may be relatively consistent for surveys taken at similar times or data gathered through similar methods, the procedure time assumptions used in developing practice expe nse inputs have not originated from consistent sources. The 60 minute procedure time assumption for IMRT treatment delivery, for example, was originally de veloped based on a specialty society survey for
CY 2002. Through our misvalued codes ini tiative and other efforts, we strive to prioritize and review values for codes each year and work toward achieving greater calibr ation of values across the PFS over time.
Comment: MedPAC commented that CMS shoul d implement its proposal to reduce the time estimates for these codes based on the credib le evidence presented in the proposed rule. The commission stated further that if stakeholde rs object to these changes, they should provide objective, valid evidence to CM S that the agency’s proposed time estimates are too low. Furthermore, the commission expressed concerns about using physician surveys to develop time estimates since physician medical societies have a financial stak e in the process. Therefore, MedPAC recommended that the AMA RUC shoul d seek evidence other than the surveys conducted by specialty societies and that CMS may need to regularly collect data on service time and other variables to establish more accurate RVUs for practice expense and physician work. Response : We appreciate MedPAC’s support for the proposal. We agree that there are many means to measure time other than th rough survey methodology, and we are open to considering robust data on pro cedure time from many sources.
Comment: Many commenters objected to CMS’ proposal to update the procedure time assumptions used in determining the direct PE inputs for these services since CMS did not propose corresponding updates to other dir ect PE inputs for the services.99
Response : We appreciate the commenters’ interest in CMS’ use of the most accurate and up-to-date information in establishing practice ex pense RVUs for these services. We note that we recently received direct PE input recommen dations from the AMA RUC for these services and used them to establish interim final direct PE inputs for CY 2012 . We also note that in the CY 2011 PFS final rule (75 FR 73205 through 73207 ) we established a public process for updating prices for supplies and equipment used as direct PE inputs. Prior to making our CY 2013 proposal regarding procedure times for the IMRT and SBRT codes, we had received no requests to update prices for the i nputs associated with these codes.
Comment: Several commenters submitted specific information regarding appropriate input revisions for CPT codes 77418 and 77373. Several commenters (including the AMA RUC) suggested that IMRT treatment requires two radiation therapists , working simultaneously, to furnish the service safely. Others suggested that the linear accelerator (ER010) and collimator (ER017) used as direct PE inputs for CPT c ode 77418 IMRT treatment are no longer typical. These commenters submitted evidence, consisti ng of a collection of paid invoices, that demonstrated that the typical accelerator used in IMRT includes the functionality of the collimator and should be priced at $ 2,641,783 and that the price of the “laser, diode, for patient positioning (Probe)” (ER040) should be $18,160. Several commenters also noted that two equipment items included in many other radiation treatment codes, the radiation treatment vault (ER056) and water chiller (ER065) ought to be included in the equipment inputs for IMRT and SBRT treatment delivery. Finally, several commen ters suggested that the equipment items used in these treatment delivery serv ices require practitioners to purchase maintenance and service contracts in addition to the pr ice of the equipment itself. Response : We appreciate all the submitted info rmation to assist us in conducting a comprehensive update of the appropriate direct PE inputs for these services. We agree with the commenters that we should use the best informati on available in developing direct PE inputs for100
PFS services. Based on this information, we be lieve it would be appropriate to include two radiation therapists as direct PE inputs fo r CPT code 77418. We also believe it would be appropriate to update the current accelerator and collimator equi pment inputs used in CPT code 77418 based on the invoices provided to us by commenters. While we generally urge stakeholders to submit such requests through the process we established for CY 2011, because we made a proposal specifically related to the equipment minutes allocated for these procedures, we believe it would be appropria te to consider the associated equipment and prices. We have observed that some other radiation treatment c odes incorporate the wate r chiller and radiation treatment vault as direct PE input s. We believe it would be appr opriate to incorporate the water chiller as an equipment item into the IMRT and SBRT treatment delivery codes for the sake of consistency with the other radiat ion treatment codes. However, we question whether it is fully consistent with the principles underlying the PFS PE methodology to continue to classify the radiation treatment vault as medical equipment (a direct cost) since it is difficult to distinguish the cost of the construction of the vault from th e cost of the constructi on of the building. The submitted architectural invoices fo r vault construction illustrate the difficulty in making that distinction. Furthermore, the ty pical circumstances of the vault’ s use are unclear, especially regarding whether or not the vault may be servicing multiple patients at the same time. However, we do not believe that it would be appr opriate to remove the ra diation treatment vault as a direct input for all PFS services for CY 2013. We expect to address the status of the radiation treatment vault as a direct PE i nput during CY 2014 rulemaking. For CY 2013, we believe that it would be appropr iate to include the radiation treatment vault for CPT codes 77373 and 77418 to align the code with the similar radiati on treatment delivery code s. In terms of the maintenance and service contract costs submitted to us by commenters, we remind stakeholders that we have generally not considered such costs as direct costs attributable to furnishing services to individual Medicare be neficiaries and that our standard equipment cost per minute calculation101

includes a maintenance factor that adequately incorporates such costs in amortizing the cost of the equipment itself
Comment: A few commenters sugge sted that CMS should re-price the capital equipment associated with CPT code 77373. However, none of these commenters submitted invoices. Response: We urge commenters to submit invoi ces and other evidence appropriate for pricing the capital equipment used in SBRT de livery as part of our public process for updating supply and equipment prices. We direct interest ed stakeholders to the CY 2011 PFS final rule (75 FR 73205-73207) for information regarding that pr ocess. We also note that as we explained in the CY 2012 PFS final rule with comment period (76 FR 73214), we could not accept the invoices accompanying the AMA RUC’s recomme ndation for CPT Code 77373 to update the price of the ‘‘SRS system, SBRT, six systems, average’’ equipment (ER083). Each of these invoices included line items that we would not accept as part of th e cost of the equipment, such as costs for training technologists to use the equi pment, and the prices for these items were not separately identifiable. Ther efore, we did not update the equipment price for ER083 in establishing interim final direct PE inputs for CY 2012. Were we to receive updated invoices through the process established during CY 2012 that did not in clude embedded costs that we would not accept as part of the cost of the equipment, we w ould consider those invoices in rulemaking for CY 2014.
Comment: Many commenters suggested that reduc tions in Medicare payment rates for these services would put serious financial strain on community radiation oncology practices, and result in significant negative impact on patient a ccess to life-saving cancer treatment, particularly in rural communities. One commenter provided the results of an informal study that suggested that if the proposed RVUs become effective for CY 2013, many providers will stop providing charity care, lay off staff, limit hours of operation, refrain from purchasing new equipment, limit or stop accepting Medicare pa tients, or consolidate or close practice locations.102
Response: We appreciate and share comment ers’ concerns regarding Medicare beneficiaries’ access to care for radiation treatmen t services. While we share these concerns in general, we believe that accurately valuing serv ices promotes Medicare beneficiaries’ access to many different kinds of important services paid under the PFS, including radiation treatment. We continue to be interested in information re lated to beneficiaries’ access to these kinds of services, and we will monitor for evidence of su ch problems. We would welcome being alerted to access problems, should they arise. At pres ent, we do not have reason to believe that the proposed changes in procedure time assumpti ons, in conjunction with other corresponding updates in the direct PE inputs for these serv ices, will jeopardize access to care for Medicare beneficiaries. We note that th e final PE RVUs for these servi ces, based on direct PE inputs updated with information provided by commenters, are significantly greater than those reflected in the proposed rule. We also note that the specialty-level impact of this final rule with comment period is significantly reduced rela tive to the policy as proposed. We direct interested readers to the section VIII.C. of this final rule with comment period regarding the specialty-level impacts of this and other finalized policies.
Comment: Many commenters objected to CMS’ a ssumptions that the services would be more costly for facilities such as hospital outpatient departments that generally have Emergency Medical Treatment and Labor Act (EMTALA) ob ligations and standby capacity than for freestanding centers or offices. These commenters stat ed that the cost structure and the services furnished in freestanding and hospi tal outpatient settings are the sa me. These commenters stated that, while outpatient hospital departments may have to mainta in standby capacity, they do not typically furnish IMRT 24 hours per day, seve n days a week nor do the radiation oncology departments of hospitals generally furnish radiat ion treatment to higher acuity patients than the patients who receive services in physicians ’ offices or freestanding clinics.103 Several other commenters suggested that the payment decrease expected to result from this proposal will force patients into the more expensive hospital setting and patients will be steered toward treatment options that result in greater financial returns. These commenters stated that this migration will increase costs both to the Medicare program and to patients through higher co-insurance payments. Others s uggested that significan t differences between nonfacility PFS and OPPS payment are likely to result in consolid ation of free-standing cancer centers and hospitals that will reduce competition, inhibit access to care, and undermine focused care for cancer patients. Response: As we stated in the proposal, we continue to believe that high-volume services, such as IMRT, that are widely furnis hed in both nonfacility and facility settings are highly unlikely to be more resource-intensive in freestanding radiati on therapy centers or physicians’ offices than when furnished in facili ties like hospitals. We agree with commenters that the direct costs of furnishi ng the service may be similar, but we continue to believe that hospitals are likely to incur additional indirect co sts. For example, hospitals incur greater costs for maintaining the capacity to furnish services 7 days per wee k, 24 hours per day, even if IMRT delivery is not typically furnished during all of those hours. As we have already noted, the disparity between OPPS and PFS payment is even greater than a dire ct comparison of the payment rates would suggest. OPPS payment fo r CPT code 77148 includes packaged payment for image guidance, which is almost always furnished and billed with CPT code 77418. The PFS continues to make separate payment fo r several forms of image guidance. We understand commenters’ concerns regardi ng the inadvertent impact that financial incentives may make on the usual site of service fo r particular services. We believe that utilizing the most accurate cost inputs possible is a reasonab le approach to mitigating the impact of such potential incentives.104

As a result of the comments we received re garding our proposal to change the procedure time assumptions used in determining direct PE inputs for CPT codes 77418 and 77373, we are finalizing our proposals to adjust the procedure time assumption for IMRT delivery (CPT code 77418) to 30 minutes and to adjust the procedur e time assumption for SBRT delivery (CPT code 77373) to 60 minutes. These codes continue to include clinical labor time for preparatory and follow-up tasks in addition to revisions to the procedure times. Based on comments received regarding additional updates to the direct PE inputs for these services, we are also adjusting other direct PE inputs for these services on an in terim final basis for CY 2013. Based on comments received on our proposal, we are incorporating a second radiation therapist for CPT code 77418. The second therapist will be allocated 30 minutes of service period time, consistent with the first. Furthermore, we are incorporating a new equipm ent item called “IMRT accelerator” to replace the linear accelerator (ER010) and collimator (ER 017) used as current direct PE inputs for CPT code 77418. Based on the evidence submitted by commenters, the new equipment item will be priced at $2,641,783 in the direct PE input database. Additiona lly, we are incorporating the radiation treatment vault (ER056) and water chill er (ER065) as direct PE inputs for both CPT codes 77418 and 77373. We are also updating th e price of the “laser, diode, for patient positioning (Probe)” (ER040) from $7,678 to $18,160. We are adopting these direct PE inputs on an interim basis for CY 2013 and these values are reflected in the CY 2013 PFS direct PE input database. That database is available under downloads for the CY 2013 PFS final rule with comment period on the CMS Web site at: http://www.cms.gov/PhysicianFeeSched/PFSFRN/list.asp#TopOfPage . We also note that the PE RVUs included in Addenda B and C reflect these interim direct PE inputs. These two IMRT and SBRT treatment delivery codes are PE only codes and are fairly unique in that the resu lting RVUs are largely comprised of resources for staff and equipment based on the minutes associated with clinical labor. There are several other codes on the PFS105 established through the same methodology. As we previously stated, we believe that the procedure time assumptions for these kinds of serv ices have not been subject to all of the same mechanisms recently used by CMS in the valu ation of the physician work component of PFS payment. In light of observations about public ly available procedure times for CPT codes 77418 (IMRT treatment delivery) and 77373 (SBRT tr eatment delivery) and public awareness of potential adverse financial incenti ves associated with IMRT treatme nt delivery in particular, we believe that similar codes may be potentially misvalued. Therefore, consistent with the requiremen t in section 1848(c)(2)(K)(ii) of the Act to examine other codes determined to be appropria te by the Secretary, we proposed to review and make adjustments to CPT codes with stand-alon e procedure time assumptions used in developing nonfacility PE RVUs. These procedure time assumptions are not based on physician time assumptions. We prioritized for review CPT co des that have annual Medicare allowed charges of $100,000 or more, include direct equipment input s that amount to $100 or more, and have PE procedure times of greater than 5 minutes. We did not propose to in clude in this category services with payment rates subject to the O PPS cap (as specified in the statute under section 1848(b)(4) of the Act and listed in Addendum G to this proposed rule) or services with PE minutes established through code descriptors. (For example, an overnight monitoring code might contain 480 minutes of monitoring equipm ent time to account for 8 hours of overnight monitoring.) The CPT codes meeting these criteria appear in Table 8. We recognized that there are other CPT codes that are valued in the sa me manner. We may consider evaluating those services as potentially misvalued codes in future rulemaking. For the services in Table 8, we requested recommendations from the AMA RUC and other public commenters on the appr opriate direct PE inputs for th ese services. We encourage the use of valid and reliable alternative data sources when developing recommended values, including electronic medical records (with pers onally-identifiable information redacted) and106 other independent data sources. We note that many of the CPT codes in Table 8 have been identified through other potentially misvalued code screens and ha ve been recently reviewed. Given our concerns with the inputs for the rece ntly reviewed IMRT and SBRT direct PE inputs discussed above, we believe it is necessary to re -review other recently reviewed services with stand-alone PE procedure time.
TABLE 8: Services with Sta nd-Alone PE Procedure Time CPT Code Short Descriptor 77280 Set radiation therapy field 77285 Set radiation therapy field 77290 Set radiation therapy field 77301 Radiotherapy dose plan imrt 77338 Design mlc device for imrt 77372 Srs linear based 77373 Sbrt delivery 77402 Radiation treatment delivery 77403 Radiation treatment delivery 77404 Radiation treatment delivery 77406 Radiation treatment delivery 77407 Radiation treatment delivery 77408 Radiation treatment delivery 77409 Radiation treatment delivery 77412 Radiation treatment delivery 77413 Radiation treatment delivery 77414 Radiation treatment delivery 77416 Radiation treatment delivery 77418 Radiation tx delivery imrt 77600 Hyperthermia treatment 77785 Hdr brachytx 1 channel 77786 Hdr brachytx 2-12 channel 77787 Hdr brachytx over 12 chan 88348 Electron microscopy

Comment: Several commenters objected to our propos al to review these codes. Some of these commenters objected to the premise that the procedure time assumptions for these services have not been subject to the same scrutiny as fo r services with procedure time assumptions tied directly to physician time. One of these comm enters explained that the AMA RUC process of107 reviewing direct practice expens e inputs involves three main le vels of expert panel review: specialty society expert panel re view and attestation of the data provided; RUC Practice Expense Subcommittee review; and full RU C member review. Other comme nters suggested that many of the identified services have procedure time assu mptions related to physic ian time and therefore should be removed from the list. Another comme nter claimed that services with professional and technical components should be removed from the list since servi ces with professional components ought not to be considered “stand-al one.” Another commenter suggested that CPT code CPT Code 77600 should be removed from the list since few -TC claims had been submitted. One commenter claimed that the AMA RUC had extensive discussions regarding the procedure time assumptions used in developing direct PE inputs for some of the codes, so that those codes should be removed from the list. Response: As we stated in the proposal, we beli eve that the proce dure time assumptions used in developing direct PE input s for these services have not been subject to the same rigor as other recently-reviewed servic es. Procedure time assumptions developed and validated by a series of expert panels have not generally be en subject to the same scrutiny as the times developed through survey data or data gathered through electronic health r ecords, for example. We identified the services by calling the services “stand-alone PE procedure time,” because they are services that include signi ficant amounts of time resources a llocated outside of physician time. We understand that some of these codes may be “technical only” codes and that in other cases these codes are used in reporting both the professional and technical component using the – TC or -26 modifiers, but we do not believe the divergent reporting mechan isms would mean that any services should be removed from the list. For CPT code 77600, we note that while few services were reported with the -TC modifier, ma ny more services were billed globally in the nonfacility setting, so we continue to believe that the procedure time assumption that determines108 the inputs used in valuing th e technical component of the payment remains relevant for prioritization. While we assume that the AMA RUC deliberated on the procedure time assumptions used in developing the direct PE input recomm endations for these services, we do not believe that extensive committee discussions would mitigate the need for more extensive review of these services as potentially misvalued since the a ssumptions that were de veloped through discussion could benefit from the object ive data of many kinds.
Comment: MedPAC supported CMS’s proposal to review these services. However, it expressed concern that CMS exempted imaging se rvices that are subject to the OPPS cap from this review. MedPAC pointed out that the pro cedure time assumptions used in several highpriced and high-expenditure imaging codes ha ve not been reviewed by the AMA RUC since 2002 or 2003 and may be too high. MedPAC also not ed that recent advances in CT and MRI machines have made it possible to scan patients faster and that even practitioners who are using older equipment could be performing studies in le ss time as they become more familiar with the procedures and equipment. Response: We appreciate MedPAC’s support for th is proposal. We agree that the procedure time assumptions used in imaging code s subject to the OPPS cap may be inaccurate or outdated. We did not propose to pr ioritize review of these proce dure time assumptions since the services are subject to the OPPS payment caps, but we will consider th e appropriate means for reviewing the procedure time assumptions fo r those services in future rulemaking. Based on the comments we received, we are finalizing our proposal to review and make adjustments to CPT codes with stand-alone pr ocedure time assumptions used in developing nonfacility PE RVUs. c. Services with Anomalous Time109 Each year when we publish the PFS proposed and final rules, we publish on the CMS website several files that support annual PFS rate setting. One of these supporting files is the physician time file, which lists the physician time associated w ith the HCPCS codes on the PFS. The physician time file associated with the CY 2013 PFS final rule with comment period is available on the CMS website under the downl oads for the CY 2013 PFS final rule with comment period at http://www.cms.gov/PhysicianFeeSched/

. As we stated in the CY 2013 PFS proposed rule , in our review of potentially misvalued codes and their inputs, we became aware of seve ral HCPCS codes that have anomalous times in our physician time file. Physician work is a m easure of physician time and intensity, so there should be no services that have payable physic ian work RVUs but no time in the physician time file, and there should be no payable services with time in the physician time file and no physician work RVUs. For CY 2013 we proposed to make the physician time file changes detailed below to address these anomalous time file entries. (1) Review of Services with Physicia n Work and No Listed Physician Time CPT code 94014 (Patient-initiat ed spirometric recording pe r 30-day period of time; includes reinforced education, tr ansmission of spirometric tracing, data capture, analysis of transmitted data, periodic recalibration and physicia n review and interpretation) has a physician work RVU of 0.52 and for CY 2012 was listed with 0 physician time. CPT code 94014 is a global service that includes CPT code 94015 (Pat ient-initiated spirometri c recording per 30-day period of time; recording (inc ludes hook-up, reinforced educati on, data transmission, data capture, trend analysis, and peri odic recalibration)) (the techni cal component), and CPT code 94016 (Patient-initiated spiromet ric recording per 30-day period of time; physician review and interpretation only) (the professi onal component). We stated that we believe it is appropriate for the physician time of CPT code 94014 to match the physician time of the code’s component professional service—CPT code 94016. As such, for CPT code 94014 for CY 2013, we110 proposed to assign 2 minutes of pre-service ev aluation time, and 20 minutes of intra-service time, which matches the times associated with CPT code 94016. HCPCS codes G0117 (Glaucoma screening fo r high risk patients furnished by an optometrist or ophthalmologist) a nd G0118 (Glaucoma screening for high risk patient furnished under the direct supervision of an optometrist or ophthalmologist) both have physician work RVUs (0.45, and 0.17, respectively) , but neither code was incl uded in the CY 2012 physician time file. HCPCS codes G0117 and G0118 have a PFS procedure status indi cator of T indicating that these services are only paid if there are no other services payable under the PFS billed on the same date by the same provider. In the CY 2002 PFS final rule (66 FR 55274), we crosswalked the physician work of HCPCS code G0117 from CPT code 99212 (Level 2 o ffice or other outpatient visit, established patient), and we crosswalked the physician work of HCPCS code G0118 from CPT code 99211 (Level 1 office or other outpatient visit, establ ished patient). Based on these finalized physician work crosswalks, we proposed to assign HCPCS code G0117 physician times matching CPT code 99212, and HCPCS code G0118 physician ti mes matching CPT code 99211. Specifically, we proposed 2 minutes of pre-se rvice time, 10 minutes of intra- service time, and 4 minutes of immediate post-service time for HCPCS code G0 117, and 5 minutes of intra-service time, and 2 minutes of immediate post-serv ice time for HCPCS code G0118 HCPCS code G0128 (Direct (f ace-to-face with patient) skil led nursing services of a registered nurse provided in a comprehensive ou tpatient rehabilitation facility, each 10 minutes beyond the first 5 minutes) currently has a physicia n work RVU ( 0.08), but was not listed in the CY 2012 physician time file. In the CY 2013 proposed rule we stated that, after review of this HCPCS code, we do not believe that HCPCS c ode G0128 describes a se rvice that includes physician work. Time for a registered nurse to fu rnish the service is included in the PE for the111 code. As such, for CY 2013, we proposed to remove the physician work RVU for HCPCS code G0128. HCPCS code G0128 continues to have PE and malpractice expense RVUs. HCPCS codes G0245 (Initial physician evaluati on and management of a diabetic patient with diabetic sensory neuropathy resulting in a loss of protective sensa tion (LOPS) which must include: (1) the diagnosis of LOPS; (2) a patient history; (3) a phys ical examination that consists of at least the following elements: (a) visual inspection of the forefoot, hindfoot and toe web spaces; (b) evaluation of a protective sensati on; (c) evaluation of foot structure and biomechanics; (d) evaluation of vascular stat us and skin integrity; and (e) evaluation and recommendation of footwear; a nd (4) patient education), G0246 (Follow-up physician evaluation and management of a diabetic patient with di abetic sensory neuropat hy resulting in a loss of protective sensation (LOPS) to incl ude at least the following: (1) a patient history; (2) a physical examination that includes: (a) visual inspection of the forefoot , hindfoot and toe web spaces; (b) evaluation of protective sensati on; (c) evaluation of foot st ructure and biomechanics; (d) evaluation of vascular status and skin inte grity; and (e) evaluati on and recommendation of footwear; and (3) patient educat ion), and G0247 (Routine foot care by a physician of a diabetic patient with diabetic sensory ne uropathy resulting in a loss of protective sensation (LOPS) to include, the local care of superficia l wounds (that is, superf icial to muscle and fascia) and at least the following if present: (1) local care of superficial wounds; (2) de bridement of corns and calluses; and (3) trimming and debridement of nails) have physician work RVUs of 0.88, 0.45, and 0.50, respectively, but were not listed in the CY 2012 physic ian time file. HCPCS codes G0245, G0246, and G0247 have a procedure status indicator of R on the PFS indicating that coverage of these services is restricted. In the CY 2003 PFS final rule (67 FR 79990), we crosswalked the physician work of HCPCS code G0245 from CPT code 99202 (Level 2 office or other outpatient visits, new patient), we crosswalked the physician work of HCPCS code G0246 from CPT code 99212, and112 we crosswalked the physician work of HCPCS code G0257 from CPT code 11040 (Debridement; skin; part ial thickness). Based on these fina lized physician work crosswalks, we proposed to assign HCPCS code G0245 physic ian times matching CPT code 99202, HCPCS code G0246 physician times matching CPT code 99212, and HCPCS code G0247 physician times matching CPT code 11040. Specifically, fo r HCPCS code G0245 we proposed 2 minutes of pre-service time, 15 minutes of intra-service time , and 5 minutes of immediate post-service time. For HCPCS code G0246 we proposed 2 minut es of pre-service time, 10 minutes of intraservice time, and 4 minutes of immediate po st-service time. For HCPCS code G0247 we proposed 7 minutes of pre-service time, 10 minu tes of intra-service time, and 7 minutes of immediate post-service time. HCPCS code G0250 (Physician review, interpre tation, and patient management of home INR (International Normalized Ratio) testing for patient with either mechanical heart valve(s), chronic atrial fibrillation, or venous thromboembolism who meets Medicare coverage criteria; testing not occurring more frequently than once a week; billing units of service include 4 tests) has a physician work RVU of 0.18 but was not listed in the CY 2012 physician time file. HCPCS code G0250 has a procedure status indicator of R on the PFS indicating that coverage of this service is restricted. In the CY 2003 fi nal rule (67 FR 79991), we assigned HCPCS code G0250 a work RVU of 0.18, which corresponds to the work RVU of CPT code 99211. While we did not articulate this as a direct crosswalk in th e CY 2003 final rule, afte r clinical review we believe that HCPCS code G0250 continues to require similar work as CPT code 99211, and should have the same amount of physician time as CPT code 99211. As such, we proposed to assign HCPCS code G0250 the same physician time as CPT code 99211. Specifically, for HCPCS code G0250 we proposed 5 minutes of in tra-service time and 2 minutes of immediate post-service time.113 During our annual review of new, revised, and potentially misvalued CPT codes, the assessment of physician time used to furnish a servic e is an important part of the clinical review when determining the appropriate work RVU for a service. However, the time in the physician time file is not used to automatically adjust th e physician work RVUs outside of that clinical review process. As such, the proposed additi on of physician time to th e HCPCS codes discussed above will have no impact on the current phys ician work RVUs for these services. The time data in the physician time file is used in the PE methodology described in section II.A.2. In creating the in direct practice cost index (IPCI), we calculate specialty-specific aggregate pools of indirect PE for all PFS servic es for that specialty by adding the product of the indirect PE/HR for the specialty, the physician time for the service, and the specialty’s utilization for the service across all services furnished by the specialty. The proposed addition of physician time to the HCPCS codes discussed above will aff ect the aggregate pools of indirect PE at the specialty level. However because the services di scussed above have low utilization and low total time, the impact of the physician time changes on the IPCI is negligible, and likely would have a modest impact if any on the PE RV Us at the individual code level. Below is a summary of the comments we received on our proposed changes for PFS services with physician work and no listed time in the physician time file.
Comment: Commenters agreed with our proposed time changes for these services. The AMA RUC noted that historically the AMA RUC has not provided work or time recommendations for HCPCS G-codes, but that they will update the AMA RUC database to reflect these new physicia n time components. Response: We thank commenters for their input on the times associated with these services. We are finalizing our proposals without modification. These proposed adjustments are reflected in the physician time file associated w ith this CY 2013 final rule with comment period,114

available on the CMS website under the downl oads for the CY 2013 PFS final rule with comment period at http://www.cms.gov/PhysicianFeeSched/.

(2) Review of Services with No Physician Work and Listed Time in the Physician Time File There are a number of services that have no physician work RVUs, yet include time in the physician time file. Many of these services are not payable under the PFS or are contractor priced services where the physician time is not used to nationa lly price the services on the PFS. We did not propose to remove the physician time from the time file for thes e services as the time has no effect on the calculation of RVUs for th e PFS. However, there are several CPT codes, listed in Table 9, that are payable under the PFS and have no physician work RVUs yet include time in the physician time file. We proposed to remove the physician time from the time file for these seven CPT codes. TABLE 9: Payable CPT Codes with Ph ysician Time and No Physician Work CPT Code Short Descriptor PFS Procedure Status CY 2012 Total Physician Time 22841 Insert spine fixation device B (Bundled, not separately payable) 5 minutes 51798 Us urine capacity measure A (Active, payable) 9 minutes 95990 Spin/brain pump refill & main A (Active, payable) 40 minutes 96904 Whole body photography R (Restr icted coverage) 80 minutes 96913 Photochemotherapy uv-a or b A (Active, payable) 90 minutes 97545 Work hardening R(Restricted coverage) 120 minutes97602 Wound(s) care nonselective B (Bundled, not separately payable) 36 minutes

As mentioned above and as discussed in sec tion II.A.2. of this final rule with comment period, to create the IPCI used in the PE met hodology, we calculated specialty-specific aggregate pools of indirect PE for all PFS services for that specialty by adding the product of the indirect PE/HR for the specialty, the physician time for the se rvice, and the specialt y’s utilization for the service across all services performed by the specialty. As we stated in the CY 2013 PFS115 proposed rule, the proposed removal of physician time from the CPT codes discussed above will affect the aggregate pools of indirect PE at the specialty level. However because the services discussed above have low utilization and/or lo w total time, the impact of the physician time changes on the IPCI is negligible, and likely will have a modest impact if any on the PE RVUs at the individual code level. Below is a summary of the comments we received on our proposed changes for PFS services with no physician work and listed time in the physician time file.
Comment: Commenters agreed with our proposal to remove the time listed in the physician time file for CPT code s 22841 (Internal spinal fixation by wiring of spinous processes (List separately in addition to code for primar y procedure)), 95990 (Refil ling and maintenance of implantable pump or reservoir for drug deliv ery, spinal (intrathecal, epidural) or brain (intraventricular), includes el ectronic analysis of pump, wh en performed;), 96904 (Whole body integumentary photography, for monitoring of high ri sk patients with dysplastic nevus syndrome or a history of dysplastic nevi, or patients with a personal or familial history of melanoma), and 96913 (Photochemotherapy (Goeckerman and/or PU VA) for severe photoresponsive dermatoses requiring at least 4-8 hours of car e under direct superv ision of the physician (includes application of medication and dressings)). Commenters noted that CPT code 51798 (Measurement of postvoiding residual urine and/or bladder capacity by ultrasound, non-imaging) likely had time listed in the physician time file b ecause the AMA RUC had recommended work RVUs for the service however CMS assigned only practice expense. Similarly, commenters noted that CPT code 97602 (Removal of devitalized tissue from woun d(s), non-selective debridement, without anesthesia (eg, wet-to-moist dr essings, enzymatic, abrasion), including topical application(s), wound assessment, and instruction(s) for ongoing care, per session) likely had time included in the physician time final because the AMA RU C HCPAC recommended work RVUs for the service, however CMS assigned CPT code 97602 a bundled procedure status. Commenters noted116 that CPT code 97545 (Work hardening/conditioning; initial 2 hours) has a restricted procedure status, but inherently involves 2 hours of work, and requested that CMS maintain the time entry in the physician time file for th is service to assist other payers and stakeholder in making payment policy decisions. Response: We thank commenters for their input on the times associated with these services. After reviewing the comments, we are finalizing our proposal to remove the time from the physician time file for CPT codes 22841, 51798, 95990, 96913, and 97602. We will maintain the time entry in the physician time file for CPT code 97545, as requested; while this CPT code has a restricted procedur e status indicator, it is still payable in some circumstances. CPT code 96904 also has a restricted procedure status indicator and is payable in some circumstances. For consistent treatment of thes e two CPT codes, we will also maintain the time entry in the physician time file for CPT code 96904. These adjustments are reflected in the physician time file associated with this CY 2013 PFS final rule with comment period, available on the CMS website under the downloads for th e CY 2013 PFS final rule with comment period

at http://www.cms.gov/PhysicianFeeSched/. 4. Expanding the Multiple Procedure Payment Reduction Policy Medicare has long employed multiple proced ure payment reduction (MPPR) policies to adjust payment to more appropriately reflect re duced resources involved w ith furnishing services that are frequently furnished together. Under these policies, we reduce payment for the second and subsequent services within the same MPPR category furnishe d in the same session or same day. These payment reductions reflect efficiencies that typically occur in either the practice expense (PE) or professional work or both when services are furnished together. With the exception of a few codes that are always repor ted along with another code, the Medicare PFS values services independently to recognize relative resources i nvolved when the service is the only one furnished in a session. While our general policy for MPPRs precedes the Affordable117 Care Act, MPPRs address the fourth category of potentially misvalued codes identified in section 1848(c)(2)(K) of the Act which is “multiple codes that are frequently billed in conjunction with furnishing a single service” (see 75 FR 73216). For CY 2013, we proposed to continue our work to recognize resource efficiencies when certain services are furnished together. We proposed to apply an MPPR to the technical component (TC) of certain cardi ovascular and ophthalmology diagnos tic tests. As discussed in the CY 2012 final rule with comment period (76 FR 73079), we are al so proceeding with applying the current MPPR policy for imaging servi ces to services furnis hed in the same session by physicians in the same group practice. a. Background Medicare has a longstanding policy to redu ce payment by 50 percent for the second and subsequent surgical procedures furnished to the same beneficiary by a single physician or physicians in the same group practice on the sa me day, largely based on the presence of efficiencies in the PE and pre- and post-surgical physician work. Effective January 1, 1995, the MPPR policy, with this same percentage reductio n, was extended to nuclear medicine diagnostic procedures (CPT codes 78306, 78320, 78802, 78803, 78806, and 78807). In the CY 1995 PFS final rule with comment period (59 FR 63410), we indicated that we woul d consider applying the policy to other diagnostic tests in the future. Consistent with recommendations of MedPAC in its March 2005 Report to the Congress on Medicare Payment Policy, for CY 2006 PFS, we extended the MPPR policy to the TC of certain diagnostic imaging procedures furnishe d on contiguous areas of the body in a single session (70 FR 70261). This MPPR policy recognizes that fo r the second and subsequent imaging procedures furnished in the same session, th ere are some efficiencies in clinical labor, supplies, and equipment time. In particular, certa in clinical labor activit ies and supplies are not118 duplicated for subsequent imaging services in the same session and, because equipment time and indirect costs are allocated based on clinical labor time, we also reduced those accordingly. The imaging MPPR policy originally app lied to computed tomography (CT) and computed tomographic angiogra phy (CTA), magnetic resonan ce imaging (MRI) and magnetic resonance angiography (MRA), and ultrasound serv ices within 11 families of codes based on imaging modality and body region and only applied to procedures furnished in a single session involving contiguous body areas within a family of codes, not across families. Additionally, the MPPR policy originally applied to TC-only services and to the TC of global services, but not to professional component (PC) services. There have been several revisions to this pol icy since it was originally adopted. Under the current imaging MPPR policy, full payment is ma de for the TC of the highest paid procedure, and payment for the TC is reduced by 50 percent for each additional procedure subject to this MPPR policy. We originally planned to phase in the imaging MPPR policy over a 2-year period, with a 25 percent reduction in CY 2006 and a 50 percent reduc tion in CY 2007 (70 FR 70263). However, the Deficit Reduction Act of 2005 (D RA) (Pub. L. 109–171) amended the statute to place a cap on the PFS payment amount for most im aging procedures at the amount paid under the hospital outpatient prospective payment system (OPPS). In view of this new OPPS payment cap, we decided in the PFS final rule with comme nt period for CY 2006 that it would be prudent to retain the imaging MPPR at 25 percent wh ile we continued to examine the appropriate payment levels (71 FR 69659). The DRA also exem pted reduced expenditures attributable to the imaging MPPR policy from the PFS BN provi sion. Effective July 1, 2010, section 1848(b)(4)(C) of the Act increased the MPPR on the TC of imaging services under the policy established in the CY 2006 PFS final rule with co mment period from 25 to 50 percent. Section 1848(c)(2)(B)(v)(IV) of the Act exempted the reduced expend itures attributable to this further change from the PFS BN provision.119 In the July 2009 U.S. Government Accountab ility Office (GAO) report entitled, Medicare Physician Payments: Fees Could Better Reflect Efficiencies Achieved when Services are Provided Together , the GAO recommended that we take furt her steps to ensure that fees for services paid under the PFS reflect efficiencies that occur when services are furnished by the same physician to the same beneficiary on the same day. The GAO recommended the following: (1) expanding the existing imaging MPPR policy for certain services to the PC to reflect efficiencies in physician work for certain imag ing services; and (2) e xpanding the MPPR to reflect PE efficiencies that occur when certain nonsurgical, nonimaging services are furnished together. The GAO report also encouraged us to fo cus on service pairs that have the most impact on Medicare spending. In its March 2010 report, MedPAC noted its c oncerns about mispricing of services under the PFS. MedPAC indicated that it would e xplore whether expanding the unit of payment through packaging or bundling would improve payment accuracy and encourage more efficient use of services. In the CYs 2009 and 2010 PFS proposed rules (73 FR 38586 and 74 FR 33554, respectively), we stated that we planned to analyze nonsurgical servi ces commonly furnished together (for example, 60 to 75 percent of the tim e) to assess whether an expansion of the MPPR policy could be warranted. MedPAC encouraged us to consider duplicat ive physician work, as well as PE, in any expansion of the MPPR policy. Section 1848(c)(2)(K) of the Act specifies that the Secretary shall identify potentially misvalued codes by examining multiple codes that are frequently billed in conjunction with furnishing a single service, and review and make a ppropriate adjustments to their relative values. As a first step in applying this provision, in the CY 2010 final rule with comment period, we implemented a limited expansion of the imaging MPPR policy to additional combinations of imaging services.120 Effective January 1, 2011, the imaging MPPR a pplies regardless of code family; that is, the policy applies to multiple imaging services fu rnished within the same family of codes or across families. This policy is consistent wi th the standard PFS MPPR policy for surgical procedures that does not group procedures by body region. The current imaging MPPR policy applies to CT and CTA, MRI and MRA, and ultrasound procedures furnished to the same beneficiary in the same session, regardless of the imaging modality, and is not limited to contiguous body areas. As we noted in the CY 2011 PFS final rule with comment period (75 FR 73228), while section 1848(c)(2)(B)(v)(VI) of the Act specifies that reduced expenditures attributable to the increase in the imaging MPPR from 25 to 50 pe rcent (effective for fee schedules established beginning with 2010 and for services furnished on or after July 1, 2010) are excluded from the PFS BN adjustment, it does not apply to reduced e xpenditures attributable to our policy change regarding additional code combinations across c ode families (noncontiguous body areas) that are subject to BN under the PFS. The complete list of codes subject to the CY 2011 MPPR policy for diagnostic imaging services is included in Addendum F. As a further step in applying the provisi ons of section 1848(c)(2)(K) of the Act, on January 1, 2011, we implemented an MPPR for therapy services. The MPPR applies to separately payable “always thera py” services, that is, services that are only paid by Medicare when furnished under a therapy plan of care. As we explained in the CY 2011 PFS final rule with comment period (75 FR 73232), the therapy MPPR does not apply to contractor-priced codes, bundled codes, and add-on codes. The complete list of codes subject to the MPPR policy for therapy services is included in Addendum H. This MPPR for therapy services was fi rst proposed in the CY 2011 proposed rule (75 FR 44075) as a 50 percent payment reducti on to the PE component of the second and subsequent therapy services for multiple “alway s therapy” services furnished to a single121 beneficiary in a single day. It applies to servi ces furnished by an individual or group practice or “incident to” a physician’ s service. However, in response to public comments, in the CY 2011 PFS final rule with comment period (75 FR 73232), we adopted a 25 percent payment reduction to the PE component of the second and subse quent therapy services for multiple “always therapy” services furnished to a sing le beneficiary in a single day. Subsequent to publication of the CY 2011 PFS final rule w ith comment period, section 3 of the Physician Payment and Therapy Relief Act of 2010 (PPTRA) (Pub. L. 111-286) revised the payment reduction percentage from 25 percent to 20 percent for therapy services for which payment is made under a fee schedule under s ection 1848 of the Act (which are services furnished in office settings, or non-institutional services). The payment reduction percentage remains at 25 percent for therapy services furnis hed in institutional settings. Section 4 of the PPTRA exempted the reduced expenditures attrib utable to the therapy MPPR policy from the PFS BN provision. Under our current policy as amended by the PPTRA, for institutional services, full payment is made for the service or unit with the highest PE and payment for the PE component for the second and subsequent procedur es or additional units of the same service is reduced by 25 percent. For non-institutional servi ces, full payment is made for the service or unit with the highest PE and payment for the PE component for the second and subsequent procedures or additional un its of the same service is reduced by 20 percent. This MPPR policy applies to multiple units of the same therapy service, as well as to multiple different “always therapy” services, when furnished to the same beneficiary on the same day. The MPPR applies when multiple therapy servi ces are billed on the same date of service for one beneficiary by the same practitioner or faci lity under the same National Provider Identifier (NPI), regardless of whether the services are furnished in one therapy discipline or multiple disciplines, including physical therapy, occupa tional therapy, or speech-language pathology.122 The MPPR policy applies in all settings where outpatient therapy serv ices are paid under Part B. This includes both serv ices that are furnished in the office setting and paid under the PFS, as well as institutional serv ices that are furnished by out patient hospitals, home health agencies, comprehensive outpatient rehabilitation facilities (CORFs), and other entities that are paid for outpatient therapy servic es at rates based on the PFS. In its June 2011 Report to Congress, MedPAC highlighted continued growth in ancillary services subject to the in-office ancillary services exception. Th e in-office ancillary exception to the general prohibition under sec tion 1877 of the Act as amended by the Ethics in Patient Referrals Act, also known as the Stark law, allo ws physicians to refer Medicare beneficiaries for designated health services, incl uding imaging, radiation therap y, home health care, durable medical equipment, clinical laboratory tests, a nd physical therapy, to entities with which they have a financial relationship under specific cond itions. MedPAC recommended that we apply a MPPR to the PC of diagnostic imaging services furnished by the same practitioner in the same session as one means to curb excess self-referral for these services. The GAO already had made a similar recommendation in its July 2009 report. In continuing to apply the provisions of section 1848(c )(2)(K) of the Act regarding potentially misvalued codes that result from “m ultiple codes that are frequently billed in conjunction with furnishing a single service, ” in the CY 2012 final rule (76 FR 73071), we expanded the MPPR to the PC of Advanced Imag ing Services (CT, MRI, and Ultrasound), that is, the same list of codes to which the MPPR on the TC of advanced imaging already applied (see Addendum F). Thus, this MPPR policy no w applies to the PC and the TC of certain diagnostic imaging codes. Specifically, we expa nded the payment reduction currently applied to the TC to apply also to the PC of the sec ond and subsequent advanced imaging services furnished by the same physician (or by two or mo re physicians in the same group practice) to the same beneficiary in the same session on the same day. However, in response to public123
comments, in the CY 2012 PFS final rule with comment period, we adopted a 25 percent payment reduction to the PC component of the second and subsequent imaging services. Under this policy, full payment is made for th e PC of the highest paid advanced imaging service, and payment is reduced by 25 percent fo r the PC for each additional advanced imaging service furnished to the same beneficiary in the same session. This policy was based on the expected efficiencies in furnishing multiple serv ices in the same sessi on due to duplication of physician work, primarily in the pr e- and post-service periods, but w ith some efficiencies in the intraservice period. This policy is consistent with the statutor y requirement for the Secretary to identify, review, and adjust the relative values of potentiall y misvalued services under the PFS as specified by section 1848(c )(2)(K) of the Act. This policy is also consistent both with our longstanding policy on surgical and nuclear medi cine diagnostic procedures, under which we apply a 50 percent payment reduc tion to second and subsequent pr ocedures. Furthermore, it was responsive to continued concerns about significant gr owth in imaging spending, and to MedPAC (March 2010 and June 2011) and GAO (July 2009) recommendations regarding the expansion of MPPR policies under the PFS to account for additional efficiencies. In the CY 2012 proposed rule (76 FR 42812), we also invited public comment on the following MPPR policies under consideration. We noted that any proposals would be presented in future rulemaking and subject to further public comment:

● Apply the MPPR to the TC of All Imaging Services . This approach would apply a payment reduction to the TC of the second and s ubsequent imaging services furnished in the same session. Such an approach could define imaging consistent with our existing definition of imaging for purposes of the statutory cap on PFS payment at the OPPS rate including X-ray, ultrasound (including echocardiography), nuclear medicine (including positron emission tomography), magnetic resonance imaging, computed tomography, and fluoroscopy, but124 excluding diagnostic and screening mammography. Add-on codes that are always furnished with another service and have been valu ed accordingly could be excluded. Such an approach would be based on the e xpected efficiencies due to duplication of clinical labor activities, supplies, and equipm ent time when multiple services are furnished together. This approach would apply to a pproximately 530 HCPCS codes, including the 119 codes to which the current imaging MPPR applies. Savings would be re distributed to other PFS services as required by the statutory PFS BN provision.

● Apply the MPPR to the PC of All Imaging Services . This approach would apply a payment reduction to the PC of the second or s ubsequent imaging services furnished in the same encounter. Such an approach could define imaging consistent with our existing definition of imaging for the cap on payment at the OPPS ra te. Add-on codes that are always furnished with another service and have been valu ed accordingly could be excluded. Such an approach would be based on effici encies due to duplication of physician work primarily in the pre- and post-se rvice periods, with smaller effici encies in the intraservice period, when multiple services are furnished together. This approach would apply to approximately 530 HCPCS codes, including the 119 codes to which the current imaging MPPR applies. Savings would be redistributed to other PFS services as required by the statut ory PFS BN provision.

● Apply the MPPR to the TC of All Diagnostic Tests . This approach would apply a payment reduction to the TC of the second and subsequent diagnostic te sts (such as radiology, cardiology, audiology, etc.) furnished in the same encounter. Add-on c odes that are always furnished with another service and have b een valued accordingly could be excluded. Such an approach would be based on the e xpected efficiencies due to duplication of clinical labor activities, supplies, and equipm ent time when multiple services are furnished together. The approach would apply to a pproximately 700 HCPCS codes, including the approximately 560 HCPCS codes that are curren tly subject to the OPPS cap. The savings125

would be redistributed to other PFS services as required by the stat utory PFS BN provision. b. MPPR Policy Clarifications (1) Apply the MPPR to Two Nuclear Medicine Procedures As indicated previously, effective Januar y 1, 1995, we implemented an MPPR for six nuclear medicine codes. Under the current poli cy, full payment is made for the highest paid procedure, and payment is reduced by 50 percent for the second procedure furnished to the same beneficiary on the same day. As noted in th e CY 2013 proposed rule (77 FR 44748), due to a technical error, the MPPR is not being app lied to CPT codes 78306 (Bone imaging; whole body) when followed by CPT code 78320 (Bone imaging; SPECT). We will apply the MPPR to these procedures effective January 1, 2013. We received the following comment on this provision:
Comment : A commenter indicated that contin uing to apply and extend the MPPR for nuclear medicine procedures is unwarranted and inconsistent with CMS’ aim to improve payment accuracy. The commenter noted that deci sions made in 1995 were based on qualitative assessments rather than on rigorous data analys is. The commenter believes that with the wealth of data now available, and improved techniques in data analysis, careful evaluation of the applicability of the MPPR for all six nuc lear medicine procedures is merited. Response : We acknowledge the commenter’s concerns, but we neither proposed discontinuing the MPPR on nuclear medicine procedures, nor extending it to new codes. Rather, we noted that the MPPR under current policy was, for technical reasons, not being applied to CPT code 78306 (Bone imaging; whole body) when followed by CPT code 78320 (Bone imaging; SPECT), and provided notification that the MPPR would be applied effective January 1, 2013. Accordingly, we are finalizing this techni cal correction effective for services furnished on or after January 1, 2013. (2) Apply the MPPR to the PC and TC of Adva nced Imaging Procedures to Physicians in the Same Group Practice126

As indicated in the CY 2012 final rule (76 FR 73077-73079), we finalized a policy to apply the MPPR to the PC and TC of the sec ond and subsequent advanced imaging procedures furnished to the same beneficiary in the sa me session by a single physician or by multiple physicians in the same group practice. Due to operational limitations, we did not apply this MPPR to multiple physicians in the same group pr actice during CY 2012. In addition, after we issued the CY 2012 final rule with comment perio d, some commenters stated that they had not commented on the application of the MPPR to physicians in the same group practice because that policy was not explicit in the CY 2012 proposed rule discussion expanding the MPPR for advanced imaging to the PC. As noted in the CY 2013 proposed rule (77 FR 44748), we have resolved the operational problems and, therefore, for services furnished on or after January 1, 2013 we will apply the MPPR to both the PC and the TC of advanced imaging procedures to multiple physicians in the same group practice (s ame group NPI). Under this policy, the MPPR will apply when one or more physicians in the sa me group practice furnish services to the same beneficiary, in the same session, on the same day. This policy is consistent with other PFS MPPR policies for surgical and therapy procedures and, effective January 1, 2013, for diagnostic cardiovascular and ophthalmology pr ocedures. We continue to believe that the typical efficiencies achieved when the same physician is furnishing multiple procedures also accrue when different physicians in the same group fu rnish multiple procedures involving the same beneficiary in the same session. While we agre e with commenters that most physicians would not change the way they practice in order to avoid application of the MPPR, we believe application of the imaging MPPR to physicians in the same group practice will ensure that there is no financial incentive for physicians in a gr oup practice to change their behavior to split imaging interpretation services for a beneficiar y among different physicians in the group. It is our intention to apply this and future MPPRs to services furnished by one or more physicians in the same group unless we determine for a specific M PPR that the efficiencies associated with an127 individual physician furnishing multiple procedures do not extend to multiple physicians in the same group practice. We received th e following comments on this provision:
Comment : Most commenters opposed applying the MPPR on diagnostic imaging to physicians in the same group practice, specifi cally to the PC. While many commenters acknowledged minimal efficiencies in the PC of second and subsequent procedures when furnished by the same physician, they maintained that no such efficiencies exist when furnished by multiple physicians. Commenters maintained that CMS assumes effi ciencies exist, but has not presented any clinical evidence or comprehensive resource use analysis to justify claims of efficiency. Commenters do not believe that s ubstantial economy of time or of effort exist. According to commenters, each physician who reviews a benefi ciary’s imaging results must review the beneficiary’s medical history, examine the imagi ng results, make diagnoses, draft a report, and enter communications with other physicians in the beneficiary’s medical chart. Commenters note that none of these actions would take less time or effort when performed by a second physician in the same practice. Commenters do not believe this proposal reflects the true costs incurred by a practice when multiple physicians fu rnish advanced imaging services to the same beneficiary on the same day. Another commente r noted that cognitive medicine, such as diagnostic imaging cannot have gl obal efficiencies, as every obs erver needs to independently investigate, collect data, formul ate an educated opinion, and furn ish a professional assessment. Commenters maintained that clinical best pr actice dictates that the images are read by subspecialized, fellowship-trained radiologists, trained to read sp ecific body parts. For example, they stated, radiologists are tr ained to read either breast, musculoskeletal, body, neurology or oncology images. Commenters indicated that th e proposal would penalize or disincentivize practices from having the most appropriate radiologist read the study, which may subject beneficiaries to undue risks.128

Commenters also noted that beneficiaries suffering from lif e-threatening conditions such as trauma, heart attacks, and cancer often require multiple imaging scans to accurately and fully assess extent of injury and m onitor disease progression and/or any improvements in condition. This is not uncommon in an urban hospital se rving high acuity benefi ciaries. Commenters maintained that as the complexity of the bene ficiary case increases, the likelihood that multiple scans and/or series will be need ed in a given day increases, and thus the number of physicians needed to review multiple scans and/or region s of the body in a series of scans increases, requiring a variety of sub-specialty-trained radiol ogists. Commenters concluded that the amount of work in the form of time, effort, and skill, does not diminish in this situation but rather has an additive effect, reflecting the clinical complexity of the beneficiary situat ion, not a duplication of efforts. A commenter noted that multi-modality im ages on a beneficiary are not always interpreted at the same time or by the same physician. According to the commenter, the beneficiary encounter that include s multiple TCs is not directly re lated to the performance of the PCs by the interpreting physician(s). The comm enter indicated that through the use of teleradiology, the interpretations often take place at separa te locations and by separate physicians. Finally, the commenter noted that this process al lows differently specialized radiologists to interpre t different images. A commenter maintained that CMS’ reli ance on both the July 2009 GAO report and the March 2010 MedPAC report to support its MPPR po licies is fundamentally flawed because such sources do not appear to justify the proposals. The commenter noted th at CMS also cites the June 2011 MedPAC report as further support for its MPPR application to the PC of diagnostic imaging services furnished by the same physician in the same session. The commenter indicated that the report’s policy recommendati on is for a multiple procedure payment reduction to the professional component of diagnostic imag ing services furnished by the same practitioner129

in the same session. The commenter stated that it could be unfair to apply the MPPR to physicians who share a practice. A commenter recommended that CMS focus on applying the results of the Medicare Imaging Demonstration, and pursuin g options to encourage use of appropriateness criteria, as the best solution to any problems of under or overutilization of imaging. Response : The policy of applying the imaging MPPR to physicians in the same group practice is consistent with other MPPR policies fo r surgical procedures an d therapy services, and effective January 1, 2013, for diagnostic ca rdiovascular and diagnostic ophthalmology procedures under the PFS. We continue to beli eve that the typical effi ciencies achieved when the same physician is furnishing multiple procedures also accrue when different physicians in the same group furnish multiple procedures involving the same beneficiary. We believe that efficiencies exist in the parts of the service that deal directly w ith patients, such as gowning and obtaining consent, as well as in the interpretatio n, where the first completed interpretation is commonly available to the second interpreting phys ician at the point of interpretation. Although efficiencies may be less when one physician is re mote, we still believe that efficiencies are within the ranges that will typically be seen across the many varied combinations of imaging services subject to the MPPR. We disagree that radiologis ts are routinely trained to only read organ specific or technology specific images. Radiol ogists receive broad training th at allows them to provide services across multiple technologies and organ systems. Some may choose to more narrowly focus their practice, but in the typical radiol ogy practice across the c ountry, many radiologists continue to provide a broad range of imaging interpretation services. We agree with the commenter that higher complexity patients may require multiple scans. However, we disagree that this higher co mplexity negates the efficiencies that are seen with less complex patients. D uplication in technical componen t, such as greeting and gowning,130 would continue irrespective of patient comple xity. Higher complexity patients, receiving multiple scans, provide greater support for the proposed MPPR policy changes. Since interpretation of an image builds on the clinical framework that the radiologist(s) develops for each patient as she reviews each scan, we believe that interpretation of multiple additional scans require diminishing marginal effort. Finally, while we agree with commenters that most physicians would not change the way they practice in order to avoi d application of the MPPR, we be lieve application of the imaging MPPR to physicians in the same group practice will ensure that there is no financial incentive for physicians in a group practice to ch ange their behavior to split im aging interpretation services for a beneficiary among different physicians in the group.

It is our intention to apply this and future MPPR policie s to services furnished by one or more physicians in the same group. Future modifica tions may be appropriate if we collect or are provided with data that indicates that the effici encies associated with an individual physician furnishing multiple procedures do not extend to mu ltiple physicians in the same group practice. We disagree that we have misinterpr eted GAO and MedPAC policy recommendations. MedPAC’s June 2011 recommendation for an MPPR on the professional component of imaging services is silent on application to the group practice, but since then, MedPAC has not opposed our proposal to apply the MPPR on the PC and TC of diagnostic imaging to physicians in the same group practice. Finally, the Medicare Imag ing Demonstration is designed to test whether the use of decision support systems can improve quality of care by diminishing patient exposure to potentially harmful radiation caused by unnecessary over-u tilization of advanced imaging services. The 2-year demonstrati on has recently completed its firs t year. The demonstration is a separate initiative and does not specifically address MPPR policy.
Comment : Many commenters noted that administra tive considerations prevented us from131 implementing this policy effective January 1, 201 2. Commenters indicate d that we have not provided a detailed explanation of how such administrative concerns were rectified. Response : Our administrative delay in implem enting the policy did not involve the merits of the policy but the practicality of impl ementation. Medicare contractors were unable to make the necessary changes to their systems to effectively operationalize the policy for CY 2012. The necessary system changes have now been made in order for this policy to be operational beginning on January 1, 2013.
Comment : Commenters expressed concern that using the NPI to define a group practice may be inaccurate. Commenters indicated that some diagnostic imaging practice members may belong to more than one NPI group; whereas othe r practitioners may be part of a smaller NPI group than their corporate struct ure would suggest. Commenters ma intained that attempts to apply the MPPR to physicians in the same group practice using the NPI co uld lead to unfair application simply due to corporate governan ce issues. Additionally, commenters noted that radiologists in a group practice may also independently contract to furnish outside interpretations for other groups. Finally, comme nters indicated that reliance on th e NPI in these cases may lead to confusion and potential compliance concerns. Response : We have traditionally relied on the group NPI to identify services furnished in the same group practice as a basis for group practice-level edits acr oss the physician fee schedule. We plan to use the group NPI for applying the MPPR to advanced imaging services at the group practice level beginning in 2013. We appreciate commenter input on this issue and understand that physicians do not always furnish se rvices within their gr oup practice and that the group NPI may reflect several different organizati onal arrangements. Accordingly, we intend to further explore the issues the commenters rais ed regarding use of th e group NPI to identify services furnished in the same group practice. For example, we could consider using a provider Tax Identification Number (TIN) as an alternativ e to the group NPI; however, we would need to132

determine whether this would cr eate other operationa l problems. Medicare contractors would also require adequate time to make the necessary systems changes. We will consider these issues and make any changes in future rulemaking.
Comment : Various commenters had the following concerns about the definition of a “session” and the use of modifier 59:

● Physicians use the 59 modifier appropr iately to bypass the MPPR when multiple services are furnished to the same beneficiary in separate sessions on the same day. However, the 59 modifier is also used for the Correct C oding Initiative (CCI) edits, creating a conflict between the two different uses of the modifier. For example, if an MRA of the head and brain are furnished to the same beneficiary on the same day, it may be appropriate to report modifier 59 to bypass the CCI edit. However, the modifier 59 may also be interpreted to bypass the MPPR, which would not be appropriate if the serv ices were furnished in the same session. They stated that this presents a quandary for both radiology practices and Medicare Administrative
Contractors.

● CMS has provided no guidance on what constitutes a separate session for professional interpretation, other th an “scans interpreted at widely different times,” leaving radiology practices vulnerable to differing interpretations by Medicare contractor s, including Recovery Audit Contractors.

● Whether CMS’ use of the word “e ncounter” is synonymous with “session.”

● Multiple physicians furnis hing the PC on different studies to the same beneficiary on the same day should constitute separate sessions by definition.

● Software programs in use for medical billi ng do not adequately capture interpretation times, and therefore, do not track whether the PC was performed in the same or different sessions and when the 59 modifier is appropriate. Commente rs expressed concern th at they will not be able to routinely identify when a Medicare beneficiary has had multiple imaging scans on the133 same day, especially if reports are generated in different locations, by different physicians, at different times of day. Radiology workflow system s triage studies to subspecialty radiologists who each separately interpret the studies and gene rate reports. Billing systems submit separate claims for each study. If two physicians read stud ies on the same beneficiary, coders and billing systems will have significant difficulty attaching the 59 modifier to the ap propriate study, even if they are able to recognize that the 59 modifier should be applied. Hospital-based radiologists rely on data feeds provided by their hospitals’ info rmation systems. These data-feeds typically include beneficiary demographic information but not image interpretation times. Because they are unable to track the time of interpretation, code rs and billers will be re quired to re-create the timing of interpretative sessions to determine whether or not the interpretation occurred in the same session.

● Radiologists in small practices, or rural hospitals and imaging facilities, are more likely to have only a few radiologists in the office. Frequently in small practices, there will be instances where beneficiaries have multiple advan ced imaging services that are in clinically separate sessions, but interpreted by the indi vidual members of the same small group of radiologists. It is not clear that there will be a way for coders, CMS contractors and auditors to understand and validate that these separate en counters constitute separate sessions.

● Contrary to CMS’ claim, commenters expect there woul d be frequent circumstances requiring the use of the 59 modifier, that is, a distinct proced ural service. Response : We are aware of the c onflict between use of modifi er 59 for CCI edits and for purposes of bypassing the MPPR when multiple pro cedures are furnished. We are considering creating a new modifier for the MPPR to reso lve this problem. In creating a new MPPR modifier, we would refine the definition of what constitutes a session. We believe that radiology imaging systems currently capture the time of each image and that image time can be provided to the interpreting radiologist(s). We also believe that radiology me dical record systems currently134 capture the time of each professional comment or interpretation, and that th e interpretation of the radiologist should contain any clinical informati on necessary to identify wh en a separate session has occurred. We believe that where billing syst ems currently do not capture this information in a readily usable form, that they will adapt to this policy and make this necessary billing information readily accessible to coders. Thus, we believe that coders will be able to determine when a separate session has occurred and will be able to append a 59 modifier (or new MPPR modifier for different sessi on) to the claim line when su ch a modifier is justified. Alternatively, we may consider modifying the MPPR policy to apply to procedures furnished on the same day, rather than in the same session. This would resolve some of the operational difficulties with the use of “session” a nd conform to the policy for all other MPPRs. If we were to modify this MPPR to apply to pr ocedures furnished on the same day rather than in the same session, we would do so through future rulemaking and subject to public comment.
Comment : Commenters indicated that applyi ng the MPPR for the PC of advanced imaging procedures to physicians in the same group practice would result in a payment reduction that would adversely affect both the quality of care and access to care. Response : We have no evidence to suggest any adverse impacts on either the quality of care or the access to care have resulted from the implementation of the MPPR to the TC of imaging in 2006 or the PC of imaging in 2012. We have no evidence that beneficiaries have been unable to obtain needed imaging, and we will continue to monitor access to care. MedPAC's analysis in its J une 2011 report indicates there ha s been continued high annual growth in the use of imaging through 2009. Fu rther, in the absence of any evidence of inadequate access or safety and quality concerns, declining growth in imaging services could be interpreted as a return to a more appropriate level of imag ing utilization. Based on our experience with the MPPR on both the TC and PC of advanced diagnostic imaging services, we135 have no reason to believe that extending the imaging MPPR to physicians in the same group practice will have a negative imp act on quality or access to care. c. Proposed MPPR for the TC of Cardiovascular and Ophthalmology Services As noted above, we continue to examine whet her it would be appropriate to apply MPPR policies to other categories of services that ar e frequently billed together, including the TC for diagnostic services other than advanced imag ing services. For CY 2013, we examined other diagnostic services to determine whether there typically are efficienci es in the technical component when multiple diagnostic services are furnished together on the same day. We have conducted an analysis of the most frequently furnished code combina tions for all diagnostic services using CY 2011 claims data. Of the seve ral areas of diagnostic te sts that we examined, we found that billing patterns and PE inputs indicated that multiple cardiovascular and ophthalmology diagnostic procedures, respectively, ar e frequently furnished together and that there is some duplication in PE inputs when this occurs. For cardiovascular diagnostic services, we reviewed the code pair/combi nations with the highest utiliza tion in the CPT code ranges of 75600 through 75893, 78414 through 78496, and 93000 through 93990. For ophthalmology diagnostic services, we reviewed the code pair/c ombinations with the highest utilization in the CPT code ranges of 76510 through 76529 and 92002 through 92371. The cardiovascular and ophthalmology diagnostic code combinations identifie d as most frequently billed together are listed in Tables 14 and 15. Under the resource-based PE me thodology, specific PE inputs of clinical labor, supplies, and equipment are used to calculate PE RVUs for each individual service. When multiple diagnostic tests are furnished to the same beneficiary on the same day, most of the clinical labor activities and some supplies are no t furnished twice. We have identified the following clinical labor activities that typically would not be duplicated for subsequent procedures:

● Greeting and gowning the patient.136

● Preparing the room, equipment and supplies.

● Education and consent.

● Completing diagnostic forms.

● Preparing charts.

● Taking history.

● Taking vitals.

● Preparing and positioning the patient.

● Cleaning the room.

● Monitoring the patient.

● Downloading, filing, identi fying and storing photos

● Developing film.

● Collating data.

● Quality Assurance documentation.

● Making phone calls.

● Reviewing prior X-rays, lab and echocardiograms. We analyzed the CY 2011 claims data for the most frequently billed cardiovascular and ophthalmology diagnostic code combinations to de termine the level of duplication present when multiple services are furnished to the sa me beneficiary on the same day. Our MPPR determination excludes the clinical staff minutes associated with the activities that are not duplicated for subsequent procedures. For purpo ses of this analysis, we retained the higher number of minutes for each duplicated clinical ac tivity, regardless of the code in the pair with which those clinical labor minutes were associated. For example, , if code A and B had 6 and 3 minutes, respectively, of clinical labor for preparing and positioni ng the beneficiary, we removed 3 minutes. If code A and B had 2 a nd 4 minutes, respectively, of clinical labor for preparing room, equipment and supplies, we rem oved 2 minutes. The lower number of minutes137 was removed, regardless of the code. If one code had no minutes for a particular clinical labor activity, then no minutes were removed for that activity. Equipment time and indirect costs are allocated based on clinical labor time; therefore, these inputs were reduced accordingly. While we observed that some supplies are duplicated, we did not factor these into our calculations because they were low cost and had little impact on our estimate of the level of duplication for each code pair. When we removed the PE inputs for activitie s that are not duplicat ed, and adjusted the equipment time and indirect costs, we found support for payment reductions ranging from 8 to 57 percent for second and subsequent cardiovasc ular procedures (volume-adjusted average reduction across all code pairs of 25 percent); and payment reductions ranging from 9 to 62 percent for second and subsequent ophthalm ology procedures (volume-adjusted average reduction across all code pairs of 32 percent). Because we found a relatively wide range of reductions by code pair, we be lieved that an across-the-board reduction of 25 percent for second and subsequent procedures (w hich is approximately the av erage reduction supported by our analysis) would be appropriate. In th e CY 2013 proposed rule (77 FR 44748-44752), we proposed to apply an MPPR to TC-only services and to the TC portion of global services for the procedures listed in Tables 12 and 13. The MPPR would apply independently to second and subsequent cardiovascular services and to sec ond and subsequent ophthalmology services. We proposed to make full payment for the TC of the highest priced procedure and to make payment at 75 percent (that is, a 25 percent reduction) of the TC for each additional procedure furnished by the same physician (or physicians in the same group practice, that is, the same group practice NPI) to the same beneficiary on the same day. We did not propose to apply an MPPR to the PC for cardiovascular and ophthalmol ogy services at this time. We believe that the proposed MPPR percenta ge represents an a ppropriate reduction for the typical delivery of multiple cardiovascular and ophthalmology services on the same day.138 Because the reduction is based on discounting the specific PE inputs that are not duplicated for second and subsequent services, the proposal is consistent with our longstanding policies on surgical, nuclear medicine di agnostic procedures, and advanc ed imaging procedures, which apply a 50 percent reduction to second and subse quent procedures, and our more recent policy on therapy services, which applies a 20 or 25 pe rcent reduction depending on the setting. Furthermore, it is consistent with section 1848(c)(2)(K) of the Act, which specifies that the Secretary shall identify potentially misval ued codes by examining multiple codes that are frequently billed in conjunction with furnis hing a single service, and review and make appropriate adjustments to their relative values. Finally, it is responsive to continued concerns about significant gr owth in spending on imaging and other diagnostic services, a nd to MedPAC (March 2010) and GAO (July 2009) recommendations regarding the expansion of MPPR policies under the PFS to account for additional efficiencies. Savings resulting from this proposal would be redistributed to other PFS services as required by the genera l statutory PFS BN provision. In summary, we proposed that for services furnished on or after January 1, 2013, we will apply the MPPR to nuclear medicine proced ures to CPT code 78306 (Bone imaging; whole body) when followed by CPT code 78320 (Bone imagi ng; SPECT). We will apply the MPPR to the PC and the TC of advanced imaging procedur es when furnished by multiple physicians in the same group practice (same group NPI). Therefor e, the MPPR will apply when one or more physicians in the same group practice furnish serv ices to the same beneficiary, in the same session, on the same day. Finally, we proposed to a pply an MPPR to TC-onl y services and to the TC portion of global services for diagnostic cardiovascular a nd ophthalmology procedures. The reduction would apply independently to cardi ovascular and ophthalm ology services. We proposed to make full payment for the TC of th e highest priced procedure and payment at 75 percent of the TC for each additional procedure furnished by the same physician (or physicians139 in the same group practice, that is, the same group practice NPI) to the same beneficiary on the same day. The following is a summary of the comments we received on this proposal to apply the MPPR to diagnostic cardiovascul ar and ophthalmology procedures:
Comment : MedPAC supported the proposal to e xpand the MPPR to cardiovascular and ophthalmology diagnostic services. Furthermor e, MedPAC encouraged CMS to examine whether there are efficiencies in physician work that occur when multiple tests are furnished in the same session that would justif y applying the MPPR to the PC of these services. For example, when multiple tests are performed together, certa in physician activities (such as reviewing the beneficiary’s medical records and discussing the findings with the referr ing physician) are likely to occur only once. In the PFS proposed rule for CY 2012 (76 FR 42812-42813), CMS solicited comments on whether the MPPR should be applied to the TC of all diagnostic tests, ra ther than just imaging procedures. In response, MedPAC examined Part B claims data from 2010 to look for diagnostic tests that are frequently furnished more than once on the same day by the same physician for the same beneficiary. MedPAC found that several su rgical pathology codes are frequently billed with more than one unit of service on the same date. For example, one-third of the claims for CPT code 88305 (Level IV, surgic al pathology, gross and microsc opic examination) contained more than one unit of service for that code. In addition, 57 percent of the claims for CPT code 88342 (immunohistochemistry, each antibody) contained more than one unit of service for that code. In these cases, it appears that multiple specimens from the same beneficiary were examined at the same time by the same pathol ogist. MedPAC indi cated that CMS should analyze whether there are efficiencies in practi ce expense or physician work that occur when multiple units of the same test are performed at the same time. If so, MedPAC suggested that CMS should consider applying the MPPR policy to these services or creating bundled codes that140 include multiple units of the same test. Me dPAC noted that these services account for a substantial and growing amount of Medicare spending. In 2010, Medicare spent $1.3 billion on CPT code 88305 and $241 million on CPT code 88342. MedPAC noted that it has recommended expa nding the MPPR to both the TC and PC of all imaging services to account fo r efficiencies in practice expens e and physician work that occur when multiple studies are furnished in the same session. A few additional commenters either agreed wi th the principle of applying the MPPR to cardiovascular and ophthalmology services or concu rred with our findings th at efficiencies exist when multiple diagnostic services are furnished on the same beneficiary on the same day. Those commenters agreed that the application of th e MPPR to the additional cardiovascular and ophthalmic diagnostic procedures is an appropr iate way to recognize such efficiencies. Response : We appreciate the support of MedPAC and other commenters for our proposal to apply the MPPR to cardiovasc ular and ophthalmology services. We agree that the MPPR is an appropriate mechanism to account for efficiencies when multiple procedures are furnished to the same beneficiary on the same day in order to ensure more accurate payments.
Comment : Most commenters opposed applying th e MPPR to the TC of diagnostic cardiovascular and ophthalmology services. Comme nters maintained that the assumption that there is major duplication in clinical labor activities is fals e when two studies are done in the same session, and especially when these services are done in separate sess ions on the same day. Commenters stated that CMS’ methodology of eliminating the smaller number of minutes assigned to one code in the fre quently performed together code pairs for clinical staff and equipment is not appropriate for pairs of services that are: (1) furnishe d by different types of clinical staff, with different expertise and training (for exam ple, radiology technologists and sonographers); (2) furnished in different types of rooms (for example, angiography suites and vascular ultrasound lab rooms); and (3) stocke d with unique equipment. According to141 commenters, many of the clinical labor activi ties considered redundant are performed multiple times, at different times of day, and in different rooms. As examples, commenters referenced the sa mple payment reduction calculations in the proposed rule for cardiovascu lar and ophthalmology services. Concerning CPT code 93306 (transthoracic echocardiography) and CPT c ode 78452 (myocardial perfusion single-photon emission computed tomography (SPECT)), commenters noted that different physicians, each supported by separately specialized clinical staff perform the se rvice in different rooms on two different types of equipment. Commenters indicated that cl inical teams for each test i ndependently greet and gown the patient, provide education, obtain co nsent, review previous exam results and studies and position the patient for the test. Commenters noted that the patient is positioned multiple times on different exam tables. According to commenters, two different clinical staff will independently review prior x-ray, laboratory, ec hocardiography studies, and other st udies. Also, separate notes are made in the patient’s records, different diag nostic forms are completed, and different quality assurance regulatory compliance information must be documented for each test. Commenters noted that two different rooms w ith different specialized equipment in two different parts of the facility are prepared and cleaned for the two unique and different services. Finally, two different machines are utilized by two differently cred entialed support staff to acquire independent and unrelated clinical testing data. Concerning CPT code 92235 (Fluorescein Angiography) and CPT code 92250 (Fundus Photography), commenters maintained that the proposal was based on an erroneous understanding of how services vary. Commenters noted that ophthalmic diagnostic tests are not equivalent to x-ray or fluorosc opic imaging, where the technician simply repositions the same device over a nearby area of the patient’s body. Co mmenters noted that ophthalmic diagnostic tests range from imaging to psychophysical test s using a number of different technologies and142 instruments that require patient participati on by responding to various stimuli to achieve an objective functional measurement of the anatomical structures within the eye. For such tests the patient must be taken to a second instrume nt and positioned, substantially reducing any redundancy in direct practice expenses. Another commenter indicated that visual field testing equipment, and other eye diagnostic equipment, do not share interfaces, space or patient information. The commenter noted that each machine requires independent input from the testing technician; including patient name, date, birth date, verification of the eye bei ng tested, and there is no shared registration of data between the two services. According to the commenter, visual field testing requires a dedicated space and is typically not performed at the same time as othe r diagnostic tests. Patients need a quiet area away from other testing and patien ts to complete the test. Both eyes are tested, each with their own input and varying lenses that must be inserted into the equipment. The commenter maintained that these tests require substantia l clinical staff time, patient instruction and interaction. Ophthalmology patients are typically elderly, often visu ally impaired and in need of mobility and positioning assistance in order to perform diagnostic eye testing. Finally, the commenter highlighted that the AMA RUC recently re moved clinical staff time from some of the codes reviewed in our analysis. Commenters disagreed that diagnostic test resource utilization for multiple diagnostic tests is comparable to those required for multiple surgeries. Commenters noted that surgical procedures generally have a 90-da y global period where more than 50 percent of the payment is related to postoperative care. Commenters also noted that in large multi-specialty practice, technical resources are located in different physical locations. Commenters recommended that CMS conduc t its study with a new methodology that takes into account both the frequency and the differ ent types of clinical staff, and the different143 types of rooms involved in the services that are performed together on the same day. Finally, commenters noted that CMS’ own anal ysis reveals payment reductions as low as 8 percent, indicating that a payment reduction of 25 percent would be ex cessive for some of these services. A commenter expressed concern th at taking this “average ” approach would have the effect of discouraging cardiologists and ophthalmologists from performing certain low overhead diagnostic procedures as the payment w ill be far less than the practice costs. The commenter suggested that in prev ious cases the identified savings were closer to the mean on average and would not result in su ch dramatic effects. Other commenters recommended that the MPPR reduction percentage should be code-specific up to a maxi mum reduction of 25 percent. Response : We appreciate the many comments submitted on this proposal. However, we disagree with commenters’ statem ents that there are minimal or no efficiencies in the TC of diagnostic cardiovascular and ophthalmology services. Concerning CPT code 93306 (transthoracic echocardiography) and CPT code 78452 (myocardial perfusion single-photon emission computed tomography (SPECT)) referenced by commenters, we agree that some cardiovascular centers might choose to employ two differently specialized technicians ; that is, nuclear medicine and echoc ardiography; to allow two different clinical staff to independently perform the studies; and to lo cate the different specialized equipment in two different parts of the practice. However, we continue to believe that is not the typical cardiovascular center or practice. We believe that the typical cardiovascular center performing these diagnostic test s commonly cross-train technician s to perform both procedures and that a single cardiologist often performs bot h tests for a single patient. In addition, we continue to believe that much of the pre-service work such as greeting and gowning the patient and reviewing medical records and previous images is redundant. We belie ve that some of the equipment used in the top code pairs is portable and can be used in the treatment room or other diagnostic room. We also do not believe that mu ltiple rooms dedicated to individual testing144 equipment is typical such that room prepar ation, greeting and gowning, and cleaning the room are never duplicated. Overall, commenters provi ded general descriptions of practices using multiple rooms and technicians to furnish these services, without sufficient information supporting a multiple room, dedicated clinical labor model as typical outside the facility setting. We would review generalizable, ro bust data demonstrating that an extensive pr actice model of multiple rooms dedicated to individual tests and di stinct dedicated technicians trained is typical practice. Concerning CPT code 92235 (Fluorescein Angiography) and CPT code 92250 (Fundus Photography), we acknowledge that these tests are not equivalent to other imaging procedures. However, we believe there are still efficiencies wh en furnished to the same patient due to some duplication of clinical labor. Con cerning visual field testing, we agre e that this is an interactive test, requiring the technician to teach the pati ent how to perform the test; however, the most intense instruction only occurs the first time a patient has visu al field testing. Although not considered in our analysis, we also note that once a patient is diagnosed with glaucoma the patient usually undergo visual field testing for the re st of their life, and th eir familiarity with the test reduces the clinical labor associated with pr oviding this service overtime. As for the other ophthalmology tests, we understand them to be mos tly passive with minimal patient instruction. Commenters expressed concerns that there is wide variation in the potential efficiencies among different code pairs; that such variab ility precludes broad application of a single percentage reduction; and, that establishing ne w combined codes is the only mechanism for capturing accurate payment for multiple imaging se rvices. In general, we believe that MPPR policies capture efficiencies when several services of the same type are furnished in the same session and that it is appropriate to apply a sing le percentage reduction to second and subsequent procedures to capture those efficiencies. Because of the myriad potential combinations of diagnostic services, establishing new combined c odes for each combination of advanced imaging145 scans is unwieldy and impractical. An MPPR policy reflects efficiencies in the aggregate, such as common patient history, application of multiple tests to the same anatomical structures by the same clinical labor, frequently with th e same modality, for the same patient. As previously noted, we found support for payment reductions ranging from 8 to 57 percent for second and subsequent cardiovasc ular procedures (volume-adjusted average reduction across all code pairs of 25 percent); and payment reductions ranging from 9 to 62 percent for second and subsequent ophthalm ology procedures (volume-adjusted average reduction across all code pairs of 32 percent). Based on this an alysis, and because we found a relatively wide range of reductions by code pair , we believed that an across-the-board reduction of 25 percent for second and subsequent proc edures, which is approximately the average reduction supported by our analysis, would be appropriate. Based on subsequent public comments, we have conducted additional analys is on ophthalmology code pairs discussed below. In response to comment that this MPPR appli cation to ophthalmic and cardiovascular diagnostic testing is not the same as the MPPR for global su rgery, we agree. We have provided our analysis for why we proposed a 25 percent reduction on s econd and subsequent diagnostic tests rather than a 50 percent reduction. We note that, as w ith many of our policies, we will continue to review this MPPR policy and refine it as needed in future years to ensure that we continue to provide accurate payments under the PFS.
Comment : A commenter noted that several ophtha lmology codes included in our analysis have been reviewed by the AMA RUC within the last year, which resulte d in the recommended removal of several minutes of clinical staff tim e for activities that the AMA RUC determined are also included within an accompanying office vis it code. The commenter indicated that CMS’ acceptance of the AMA RUC recommendation, as we ll as applying the MPPR, would effectively double the practice expense reductions. The codes reviewed by the AMA RUC for CY 2013 were: CPT codes 92081-92083 (Visual field exam inations), CPT code 92235 (Fluorescein146 angiography) and CPT code 92286 (Internal eye photography). As discussed above, commenters noted that visual field testing equipment a nd other eye diagnostic equipment do not share interfaces, space or patient informa tion, that there is no shared info rmation with other tests, that the tests required separate staff time and clinical instruction, and th at visual field testing happens in a dedicated space away from other testing. The commenter requested that any ophthalmic tests that had their time reduced because of duplication with an office visit should be rem oved from the list of codes subject to the MPPR. Specifically, the commenter requested that th e three visual field tests CPT codes 92081, 92082 and 92083 and CPT code 92235 (Fluorescein angi ography) and CPT code 92286 (Internal eye photography) for which minutes were reduced that we re not reflected in the CMS analysis should be removed from the list. Additionally, the commenter indicated that CPT codes 92133, 92134 and 92285 all had their clinical staff labor ti mes previously reduced during the AMA RUC consideration and should not be included in the MPPR. Commenters also expressed c oncern about CPT codes that ha ve recently been reviewed or are in the process of being reviewed unde r the various misvalued services screens. Commenters noted that these codes have already been subjected to a process where duplicative minutes have been reduced. Therefore, they requ ested that any codes for procedures where the AMA RUC has reviewed the PE inputs in the last 2 years be removed from this proposed list of services. Response : Our original proposed rule analysis for the subject ophthalmology codes was based on the latest AMA RUC PE worksheets available at that time. The PE worksheets are the basis for the direct practice expense inputs used in the PE methodology. They delineate minutes of the clinical staff time, equipment, and suppl ies for each clinical labor activity, for each CPT code. We subsequently reviewed the CY 2013 PE worksheets for the subject codes, which appeared in many of the ophthalmology code co mbinations reviewed. The AMA RUC did not147

reduce clinical labor minutes for CY 2013 for tw o of the reviewed code pairs (76514 with 92286 and 92081 with 92285). The most significant change in clinical labor activities for the other reviewed code pairs was the reduction of time for preparing and positioning the patient from either 7 or 10 minutes to 2 minutes. Because we never reduced this activity by more than 2 minutes, the AMA RUC changes to this clinical labor activity had no effect on our calculation. In all cases, the subject codes ar e the highest paid codes in the code combination. The payment reductions range from 9 to 62 percent for s econd and subsequent opht halmology procedures, noted in the proposed rule, remains unchange d. However, the volume-adjusted average reduction across all code pairs, or iginally calculated at 32 percent is revised to 22 percent. We disagree that recently reviewed codes s hould be exempt from the MPPR. However, we agree that the analysis establishing an M PPR should be based on the most current practice expense data available, and that the recent clinical labor reduc tions made to the subject codes should be taken into account. Therefore, based on our revised analysis, we are reducing the final MPPR on ophthalmology services from 25 percent to 20 percent to more accurately reflect the new data.
Comment : Commenters expressed concern abou t the lack of transparency in the methodology and data sets used to develop the proposed MPPR. Commenters noted that CMS did not post basic data files on its website until August 10, 2012, le ss than 30 calendar days from the comment deadline. Commenters also indicated that the posted data did not enable them to understand the cuts or replicate the data used to form the basis of the proposed MPPR. Commenters believed that this unfairly hampered their ability to fully analyze the proposal. Commenters urged us not to implement this proposed policy until full access to the data used to develop the policy is provided. Response : We have provided full access to the da ta that we used to develop the policy. We have listed every code pair reviewed and every clinical labor activity considered for148 duplication. In addition, we provi ded a description of how the an alysis was conducted, the range of reductions found and the adju sted average reduction determ ined for cardiovascular and ophthalmology services. We acknowledge that th e PE worksheets were not made available simultaneously with the publicati on of the proposed rule. Upon re ceiving requests from various specialty groups to supplement the information we provided in the proposed rule, we posted the PE worksheets used in the analysis on our website. We posted these data in August 2012, approximately one month before the comment period ended. We believe the information provided in the proposed rule would have been sufficient to permit full consideration of our proposed policy, but agreed to pr ovide greater detail to assist commenters in further evaluating the proposal.
Comment : Commenters indicated that we stated in the proposed rule that the code pairs published the MPPR analysis are frequently billed together. However, the AMA RUC determined that only four of the cardiology pairs (CPT codes 93320-93325, 93320-93351, 93965-93970 and 78452TC-93017), and only one ophthalmology code pair (CPT codes 92235 and 92250), are typically reported toge ther on the same date of serv ice. Commenters stated that the computerized ophthalmic diagnostic imag ing codes (92133 and 923134) were created in 2011 and were not included in this analysis. Commenters further noted that every other code pair is reported t ogether at or below 40 percent of the time, with over half below 20 percent. They stated that not only are these services not commonly billed together, they are not performed on contiguous body parts and are not always performed on the same type of equipmen t or even in the same room. Further, the services would sometimes be performed by diff erent physicians in the same group practice. In addition, commenters indicated that a broader analysis of the claims data for all the analyzed codes pairs for cardi ovascular and ophthalmology sugge st that only roughly four percent of the code combinations are typically performed together on the same date of service.149

Given that these services are ra rely performed on the same day together, it is unreasonable to assume there would be efficiencies gained when these services are performed together. Commenters maintained that efficiencies in practice expense are pot entially created only when the two services are similar, use the same instrument, and are commonly performed together. Commenters indicated, however, that for more low-volume code pairs, the practice will not have the same level of familiarity, including the office equipment set up, to conduct these services. Commenters further noted that the differences between these services are such that even if all these services were commonly billed together, physician staff could not provide noticeable efficiencies. Response : In the CY 2013 proposed rule (77 FR 44748), we indicated that we analyzed the CY 2011 claims data for the most frequently bille d cardiovascular and ophthalmology diagnostic code combinations to de termine the level of duplication present when multiple services are furnished to the same patient on the same day. For cardiovascular diagnostic services, we reviewed the code pair/combinations with the highest utilization in code ranges 75600 through 75893, 78414 through 78496, and 93000 through 93990. For ophthalmology diagnostic services, we reviewed th e code pair/combinations with the highest utilization in code ranges 76510 through 76529 and 92002 through 92371. The frequency of code combinations review ed for cardiovascular services ranged from 260 to 207,573 and for ophthalmology services from 4,193 to 553,502. Although utilization was low for some code combinations reviewed, we examined the top highest frequency code combinations for each of the five code groups examined (three for cardiovascular and two for ophthalmology). The frequency with which a code combination is furnished does not diminish the potential efficiencies in clinic al labor activities that will occur when that code combination is furnished. All MPPR policies (surgery, diagnosti c imaging and therapy) apply to all code combinations of procedures subject to the polic y, regardless of the fr equency that the code150
combination was furnished. Therefore, we be lieve it is appropriate to apply the MPPR regardless of the frequency which the code combin ation is billed. Applying the MPPR to code combinations furnished infrequently will have a minimal effect on overall payments for imaging services. Finally, we based our final reco mmended percent reduction on the volume-adjusted average reduction observed in our code pair an alysis, which ensures that when the MPPR is applied, the reduction adjustment is more likely to reflect the actual reduction for the code pair. MPPR policies have been consistently applied to all multiple procedures and are not restricted to those with the highest frequency of billings.
Comment : Commenters noted that the MPPR is partly designed to address the growth in imaging and diagnostic services, as noted by MedP AC. Commenters further noted that in recent years the rate of imaging growth for both Medi care and private payor patients has slowed considerably, and concluded that additional payment reductions are unwarranted and unnecessary. Commenters cited an article in the August 2012 issue of Health Affairs further confirming this trend, noting that the growth rate of advanceddiagnostic imaging slowed to single digits beginning in 2006. Th e study concluded that the use of MRI in Medicare slowed to an average 2.6 percent annual growth rate from 2006-2009. In addition, commenters maintained that 2008 and 2009 data from MedPAC and the AMA demonstrate that the rate of volume growth for diagnostic imaging serv ices overall is now generally lowe r than the rate of growth for all other physicians’ services. Commenters furthe r maintained that the volume of all physicians’ services grew by 3.6 percent in 2008 and 2009 while the volume of diagnostic imaging services rose by 3.3 percent in 2008 and 2.2 percent in 2009. Another commenter noted that ultrasound servic es have never experienced rapid growth, but rather, have experienced only moderate growth. The commenter cited GAO’s September 2008 report to Congress that found th at after the implementation of DRA cap, which for vascular ultrasound services resulted in reductions of great er than 40 percent, the disparity in utilization151 between ultrasound and expensive, advanced imaging modalities continued to grow. The commenter noted that this is reflected by th e Congressional Budget O ffice’s (CBO) December 2008 recommendations to Congress in which it excluded ultrasound and other inexpensive imaging modalities from its policy recomme ndations on advanced imaging services. Commenters concluded that imaging has absorbed numerous payment reductions and that it is illogical to target procedures for reduction that do not demonstrate a pattern of rapid growth. Response : MedPAC's analysis in its June 2011 report indicates there has been continued annual growth in the use of imaging. While overall growth may be lower than it was in the last decade, declining growth in imaging services could be interpreted as a return to a more appropriate level of imaging utilization w ithout any accompanying evidence of inadequate access or safety and quality concerns. As indi cated previously, MedPAC has expressed support for the MPPR on diagnostic cardiovascul ar and ophthalmology services.
Comment : A commenter noted that many of the c ode pair combinations identified by CMS for the MPPR on cardiovascular services are not cardiovascular services, specifically, CPT 75600-75893, 78414-78496, and 93000-93990. The commenter fu rther noted that it is highly unlikely that these codes would be furnished to the same patient on the same day by the same physician. For example, the AMA RUC database indicates CPT code 93980 for penile vascular study was provided by cardiologists less than 1 pe rcent of the time to Medicare patients in 2011. The commenter did not recommend removing th e codes from the MPPR list because their presence produces no impact. However, the co mmenter indicated that the inclusion of codes unrelated to cardiovascular creat es doubts about the thoroughness a nd validity of the analysis underlying the proposal. Response : In reviewing the group of codes that we refer to as cardiovascular services, we looked at services involving the heart and vessels, regardless of the specialty that furnishes them. For example, penile vascular services are vascular services. Whereas we would not152 expect a urologist to perform tr ans-esophageal echoes, nor would we expect a cardiologist to perform penile studies, we woul d not be surprised to find some generalists, or even general vascular surgeons, evaluating the penile vasculature along with, fo r example, the vasculature of the lower extremities. And even if, as the comm enter suggested, it would be unlikely for certain codes to be billed by the same physician on the same day, then the MPPR simply would not apply.
Comment : Commenters questioned how the M PPR on cardiovascular services would apply to remote monitoring CPT codes 93279-93296. Specifically, they indicated that it is unclear whether the date of servi ce is: (1) the day the patient tran smits their data; (2) the day the data is received in the physician’s office for t echnician review, technical support and distribution of results; or (3) the day the physician reviews the data; all of which may represent different dates of service. The commenters indicated that b ecause there is no specific identification of the date of service within the CPT description, applying the MP PR is likely to create confusion among physicians. Commenters recommended that we either remove these codes from the list subject to the MPPR or issue instructions that specifically indicate how dates of service within the 90-day monitoring period should be addressed. Another commenter noted that CPT c odes 93293(Transtelephonic rhythm strip pacemaker evaluation(s) single, dual, or multip le lead pacemaker system, includes recording with and without magnet application with analysis , review and report(s) by a physician or other qualified health care professional, up to 90 days), 93296 (Interrogation device evaluation(s) (remote), up to 90 days; single, dual, or mu ltiple lead pacemaker system or implantable cardioverter-defibrillator system, remote data acquisition(s), receipt of transmissions and technician review, technical s upport and distribution of results), and 93299 (Interrogation device evaluation(s), (remote) up to 30 days; implantabl e cardiovascular monitor system or implantable loop recorder system, remote data acquisition(s), receipt of transmissions and technician review,153 technical support and distribution of results) desc ribe the TC for remote interrogation of the devices, meaning that the patient is not physically present when the service is furnished. The commenter questioned how it is possible for efficien cies to exist in the rare circumstance these services were furnished on the same date as a cardiovascular diagnostic se rvice. The commenter indicated that the inclusion of these codes demonstrates a lack of understanding of how diagnostic services are furnis hed to beneficiaries. Response : The appropriate date of service used to bill codes subject to the MPPR is the same as required by Medicare billin g instructions. We note that c odes in the range of CPT codes 92293 through 92299 should be consiste ntly treated regarding applic ation of the MPPR. Since we did not propose to include all codes in this range for the MPPR, we have removed remote monitoring codes CPT codes 93293 and 93296 from the list of procedures subject to the MPPR. We note that CPT code 93299 was not on the proposed list.
Comment : A commenter noted that diagnostic ultrasound offers a number of important advantages compared to CT and MRI, in terms of safety and effectiveness. For example, ultrasound is non-invasive and offers real-time im aging, allowing for examinations of structures at rest and in motion and does not use ionizi ng radiation. Although not always a good substitute for other advanced imaging modalities, ultrasound is an effective diagnostic tool in many cases. The commenter further noted that, due to th e relatively low payment rates for ultrasound procedures, they are one of the most cost-effective diagnos tic imaging modalities. The commenter indicated that analyses performed by GAO in 2008 and others have shown that lower cost imaging modalities such as ultrasound have declined in use relative to more expensive imaging modalities, negatively impacting the quality and cost of their health care. The commenter concluded that payment reductions to ultrasound services have threatened the ability to furnish such services. Therefore, the commenter requested removal of154 all ultrasound procedures from th e list of procedures subject to the MPPR on cardiovascular services. Another commenter noted that the June 2011 MedPAC report focused on advanced diagnostic imaging services and supported increa sing, rather than decreasing, the payments for ultrasound services. The commenter indicated that the report suggests reforming the Medicare fee-for-service system to encourage the use of hi gh-value services and discourage the use of lowvalue services. In describing what is meant by low-valued services , MedPAC points to situations where two services may be equally safe and effective, yet one is mo re expensive than the other. The commenter indicates that this is the situation with ultraso und as compared to other, more expensive imaging services. Finally, the commenter noted that the report s uggested that services that can potentially harm patients, for example, overexposure to radiation, should be considered low-value. The commenter indi cates that ultrasound, which is non-ionizing, poses less risk to patients than other modalities. Response : The MPPR on diagnostic imaging pr ocedures has included CT, MRI and ultrasound since 2006. MedPAC, as noted in its comment above, has supported our previous MPPR proposals and has not recommended ex cluding ultrasound from MPPR on diagnostic cardiovascular and ophthalmology services. MPPR policies are resource-based. MPPR policies for the TC reduce payment in situations where there is overlap in resources employed in the delivery of multiple services, with comparable pr actice expense inputs, when those resources are only employed once. We do not apply the MPPR to ultrasound used in place of other modalities, only when it is used in addition to, other moda lities in the same session. We do not expect the MPPR to encourage radiologists to forego ultr asound imaging in favor of advanced imaging modalities.
Comment : Commenters noted that the AMA RUC and the CPT Editorial Panels have been working to combine services frequently billed together into comprehensive codes and to155 remove overlapping physicians’ services from the payment rates. Commenters indicated that the effort to combine codes and reduce payment fo r duplicate services has been accelerated by CMS after the threshold for analyzing services bill ed together was reduced from 95 percent to 75 percent overlap. Commenters urged CMS to be mindful of this work and to fully take into account the AMA RUC review of the code pa irs. Commenters found it contradi ctory for CMS to utilize the AMA RUC process and accept the PE payment prin ciple, only to disregard the methodology in applying an MPPR; and suggested that duplication of work in se rvices performed on the same date of service should be addresse d at the individual code level rather than through an MPPR. Another commenter recommended that CMS as k the AMA RUC to review the codes and make code-specific recommendations and claime d that implementing payment reductions that are not specific does a disservice to the entire AMA RUC process and all of the physicians who are paid under the PFS. Commenters disputed the assumption that an MPPR is a valid and accurate mechanism to value services when performed on the same da te of service. Commenters indicated that, historically, the AMA RUC has r ecognized that efficiencies can be gained when services are commonly performed by the same physician on the sa me date of service, but only when explicit criteria are met. The commenters indicated that the proposal fails to meet these criteria because the services are not commonly billed together , are not analogous services performed on contiguous body parts, and applie s to both individual physicians and physicians in the same group practice. Commenters maintained that the vague justifi cation for selecting particular codes in the CY 2013 rule stands in stark contrast to the AMA RUC. According to commenters, the AMA RUC process set a clear and distinct threshold for analyzing codes bille d together, that is, 75 percent of the time. In contrast, according to commenters, the proposal fails to define156 “frequently billed” thus creati ng a substantial barrier to a cl ear comprehension of the MPPR expansion. Response : As we have indicated previously (76 FR 73077-73078), the MPPR is not intended to supersede the AMA RUC process of developing recommended values for services described by CPT codes. We continue to a ppreciate the work done by the AMA RUC and encourage the AMA RUC to continue examini ng code pairs for duplication based upon the typical case, and appropr iately valuing new comp rehensive codes for bundled services that are established by the CPT Editorial Panel. We vi ew the AMA RUC process and the MPPR policy as complimentary and equally reasonable means to the appropriate valuation and payment for services under the PFS. We note that as more code combinations are bundled into a single complete service reported by one CPT code, th e MPPR policy would no longer apply to the combined services. At the same time, the a doption of the MPPR for the TC of diagnostic cardiovascular and ophthalmology services will addr ess duplications in the PE to ensure that Medicare payment for multiple diagnostic services better reflects the resources involved in providing those services. As noted previously, although less precise than creating new comprehensive codes to capture each unique combination of diagnostic serv ices that could be performed together, we believe that an MPPR policy appropriately a ddresses efficiencies present when multiple diagnostic services are furnished together. Mo reover, we believe it would be unwieldy and impractical to develop unique codes and values for the myriad of procedure combinations that could be furnished together. In addition, we be lieve that the expansion of the MPPR policy to the TC of diagnostic cardiovascul ar and ophthalmology services is consistent with both the GAO and MedPAC recommendations. Finally, we already have discussed information on the determination of frequently billed services in response to comments on this rule concerning the most frequently billed cardiova scular and ophthalmology diagnostic code combinations used in157 our analysis.
Comment : A commenter indicated that the st atutory authority cited by CMS for the proposed MPPR expansion and new MPPR policy onl y grants CMS the authority to modify the reimbursement for “codes” and does not provide CMS with the authority to implement multiple service reductions. The commenter maintains th at Congress bestowed CMS with specific and limited authority to implement multiple service reductio ns in another part of the Act and that this confirms that Congress did not intend to pr ovide the authority that CMS claims under the “misevaluation” clause. The commenter stated th at the misvalued codes section of the Act that addresses multiple services frequently billed together as potentially misvalued does not give CMS the authority to implement either of its pr oposed MPPR policies. The commenter did not believe that the codes are “misvalued” within th e meaning of the statutory provision CMS cites, and maintains that CMS has effectively conceded this point, as it continues to use the existing relative value units (RVUs) for single services . The commenter maintains that CMS is not contending that the activities and it ems described in the RVUs are not, in fact, part of the service; but rather, CMS is attempting to effectively re set the conversion factor based on its assumption that costs can be saved in multiple procedure scenarios, but the statute does not permit CMS to institute multiple conversion factors. Anot her commenter merely suggested that there was inadequate legal basis for the proposal. Another commenter noted that payment rates for x-rays under the OPPS are significantly higher than payment rates under the PFS. The co mmenter indicated that application of the MPPR in a non-hospital setting wi ll cause procedures to shift to the hospital setting. The commenter recommended paying the lower of (1) full payment under the OPPS rate for procedure with the higher fee, a nd 50 percent of the OPPS rate fo r the second procedure, or (2) full payment for both procedures under the PFS. Response : We believe that the application of the MPPR to the PC of second and158 subsequent advanced imaging services furnished in the same session to the same patient is fully consistent with section 1848(c)(2)(K) of the Act, especially given our auth ority to adopt ancillary policies under section 1848(c)(4). We also note that we have had several MPPR policies in place for many years before the enactment of section 1848(c)(2)(K) of the Act. As explained previously, sect ion 1848(c)(2)(K)(i) of the Ac t requires the Secretary to identify services within several specific categor ies as being potentially misvalued and to make appropriate adjustments to their relative valu es. One of the specific categories listed under section 1834(c)(2)(K)(ii) of the Act is ‘‘multiple c odes that are frequently billed in conjunction with furnishing a single service.’’ Alt hough some code pair combinations will occur infrequently, the codes subject to the MPPR are frequently found in groups of multiple codes that are billed in conjunction with fu rnishing a single service. Se ction 1848(c)(2)(K)(ii) of the Act specifies that we should examin e not only individual codes, but also families of codes. We believe the MPPR policy contributes to fulfillin g our statutory obligatio ns under section 1848(c) of the Act by more appropriately valuing combinations of imaging services furnished to patients and paid under the PFS. As previously noted, Medicare has a long-st anding policy of applying an MPPR to surgical procedures. While the various MPPRs have been adopted thro ugh notice and comment rulemaking as administrative actions, the Congr ess has acknowledged our authority to adopt MPPRs by directly modifying several of them, and by exempting the payment changes relating to several others from budget neutrality adju stment under the PFS. For example, section 5102 (a) of the DRA exempted from the PFS budget neutra lity adjustment the changes in expenditures resulting from the MPPR on the TC of diagnosti c imaging. Section 3135 (b) of the Affordable Care Act increased the MPPR reduction percentage on the TC of diagnostic imaging from 25 to 50 percent. Sections 3 and 4 of the PPATRA decreased the M PPR reduction percentage on the PE of therapy services from 25 to 20 percent for th erapy services furnished in office settings, and159 exempted from budget neutrality the change in expenditures resulting fr om the MPPR on therapy services from budget neutrality. We appreciate the commenter’s sugges tions concerning a lternate payment methodologies, that is, payments based on the OPPS rate, and we will consider them further for possible rulemaking in the future.
Comment : A commenter noted that the proposed list of cardiovascular procedures subject to the MPPR did not include the global services that have diffe rent procedure codes than the corresponding technical services, which are on the list. The co mmenter specifically mentioned CPT codes 93005, 93016, 93040, and 93224, representing global services for electrocardiograms, cardiac stress tests, rhyt hm electrocardiograms, and Holter monitors, respectively. Lastly, the commenter noted th at, because such codes were not proposed for inclusion in the MPPR, it would vi olate the Administrative Procedur e Act to subject them to the MPPR through this final rule. Response : The commenter is correc t that we had not specifically identified global services that have different CPT codes than the correspondi ng TC on the proposed cardiovascular MPPR code list. However, we in dicated in the proposed rule (77 FR 44749) that the MPPR applies to TC services and the TC of global services. As such, it is consistent with the proposed policy (which we are fi nalizing in this final rule w ith comment period as described here), and not inconsistent with the Administrative Procedure Ac t, to include these codes on the list of codes to which the MPPR will apply. In response to the comment, we have added the following global services to the cardiovascular MPPR list: CPT code 93000 (Electrocardiogram complete); CPT code 93015 (Cardiovascular st ress test); CPT code 93040 (Rhythm ECG with report); CPT code 93224 (Ecg monit/reprt up to 48 hrs); CPT code 93268 (ECG record/review); and CPT code 93784 (Ambulatory BP monitoring). The technical portion(s) of such codes will be subject to the MPPR. We note that CPT c ode 93005 (Electrocardiogra m tracing) is a TC160 service already on the list, and CPT code 93016 (Car diovascular stress test ) is a PC service not subject to the MPPR.
Comment : Several commenters noted that the following add-on codes were included on the list of procedures subject to the MPPR on cardiovascular procedures: CPT code 75774 (Artery x-ray each vessel); CPT code 78496 (H eart first pass add-on); CPT code 93320 (Doppler echo exam heart); CPT code 93321 (Doppler ech o exam heart); and CPT code 93325 (Doppler color flow add-on). Commenters indicated that su ch codes have already been valued to reflect efficiencies. Response : We agree that these codes should not be subject to the MMPR and have removed them from the list. While three of th ese codes were included in our analysis, their inclusion had no effect on the results. For example, CPT codes 93320 and 93325 contain none of the clinical labor activities that might be duplicated. While dup licated clinical labor was noted in the code combinations including CPT code 77774, it affected neither the payment reduction range of 8 to 57 percent for second and subseque nt procedures, nor, due to the extremely low utilization, the volume-adjusted average reduction acr oss all code pairs of 25 percent.
Comment : Commenters noted that it was unclear exactly how we adjusted the equipment minutes in calculating the MPPR reduction and requested additional details. Response : In general, the minutes allocated to particular direct PE equipment items are based on the amount of time clinical labor would use the equipment for a typical service. When the clinical labor minutes were reduced in our analysis, and those minutes had been used to allocate minutes to the equipment, we made corresponding reductions to the equipment minutes so that the equipment minutes matched th e adjusted clinical labor times.
Comment : One commenter expressed concern that because pediatric cardiologists assess multiple aspects of a patient’s cardiovascular st atus, the MPPR on cardiovascular services has an unjust impact on pediatric cardiology practices in the diagnosis and treatment of congenital heart161

diseases. The commenter noted that the functio nal and structural assessment of these multiple aspects requires the pediatric cardiologist to perf orm multiple procedures on the pediatric patient. It also requires special tr aining and more time than a non- congenital adult assessment. According to the commenter, an echocardiogram performed to evaluate for congenital heart disease includes multiple types of different proc edures/assessments which require a unique level of skill, training, and time when compared to the adult non-congenital assessment. The commenter urged us to exclude th e following codes from the MPPR on cardiovascular services: CPT codes 93303 and 93304 (Congenital transthoracic echocardiography); CPT code 93308 (Limited non-conge nital code used for follow-up studies); and CPT codes 93320, 93321 and 93325 (Spectral and Color Doppler). The commenter maintained that excluding these codes woul d have no demonstrable effect on Medicare utilization of cardiology servic es since cardiologists treating adult patients rarely bill the congenital echocardiography codes to Medicare. The commenter noted that because most adult non-congenital transthoracic echocar diography studies that are bill ed to Medicare have been bundled into CPT code 93306 (including non-co ngenital echocardiography CPT codes 93307, 93320 and 93325), the significant decrease in payment for the subject codes would disproportionately impact pediatric cardiologists. The commenter further noted that state Medi caid agencies and private sector health insurance payors use Medicare gui delines and RVU valuations to establish their own payment protocols. Therefore, the repercussions of th ese reductions will extend across all payor sources for pediatric cardiology practices and have a materially signi ficant impact on the financial viability of many practices. Finally, the commente r indicated that the inclusion of the subject codes in the proposed MPPR w ould exacerbate the current shortage of available fellowship positions that recruit medical residents into pedi atric cardiology, and will impair their ability to provide patient access to this li fe-saving specialty care, especially to medically underserved162

areas. Response : We appreciate the commenter’s concerns as to the impact of this policy on pediatricians. While we rec ognize that echocardiogra phy training for congenital cardiovascular abnormalities may be different from that for adults , we are not convinced that the MPPR does is not equally applicable to pediatri c and adult cardiologists. The purpose of the MPPR policy is to account for the efficiencies inherent when multiple procedures are furnished together. We do not believe that those efficiencies differ significantly from diagnos tic testing on adults versus pediatric patients for these code pairs. We considered the specific scenarios presen ted by the commenter’s in the context of MPPR methodology and identified the same or si milar efficiencies regardless of whether the multiple diagnostic procedures were targeted at abnormal flow in response to congenital structural abnormalities or were targeted at functional abnormalities in response to primary vascular disease. We also noted that, whereas practitioners who perform more services that are reported separately will be impacted more by th e MPPR, practitioners who report more services that have recently been bundled together will ha ve a similar impact due to the efficiencies that were considered by CMS in the va luation of those new bundled codes. Finally, we note that the codes are not specific to pediat ric patients so it is not possibl e to exclude them for pediatric cardiologists alone. In response to the commenters concerns that other insurers may adopt our policies, we do not modify Medicare payment policy based on th e fact that Medicaid and other payors may adopt such policies. We understand that othe r payors have their own unique payment systems and consider the appropriateness of CMS valuatio ns in their decisions to accept, modify or ignore our payments. We continue to believe that the MPPR policy that we are adopting in this final rule with comment period is appropriate for Medicare. Therefor e, we are not excluding these codes from the MPPR.163

Comment: Several commenters maintained that the policy could re sult in the following unintended consequences:

● Create a disincentive for specialists to pr ovide efficient, high quality and continuous care to their patients. Penalize the use of the a ppropriate sub-specialist, resulting in generalist physicians conducting multiple reads, leading to a degradation of di agnostic interpretation quality.

● Have a negative impact on investment in new advanced imaging technology and stifle innovation. New equipment offers more precise images and the addition of highly-trained personnel to a medical practice is in tegral to high quality patient care. Inhibit staff training and the addition of staff in a state of uncertainty.

● Lead to a forced reduction in necessary services, compromising patient access to lifesaving diagnostic imaging services in all sett ings, including independe nt practices, community hospitals, and large academic medical centers.

● Drive more services out of physicians’ offices and into more expensive hospital settings, fragment care, a nd increase patient costs.

● Reduce the efficiency of patient care and inconvenience patients because many would be scheduled for multiple procedures over multiple days instead of just one day. This would particularly disadvantage patients with serious medical conditions, such as multiple traumas, heart attacks, strokes, and cancer, who require frequent and multiple imaging.

● Disproportionally affect radi ologists in academic medical centers who are often part of large group practices and who furn ish care to a more complex pati ent population. These patients are often suffering from acute trauma or underg oing treatment for cancer and are more likely to have multiple examinations on the same day.

● Contradict the goal to focus more on prev entive care, as diagnostic tests enable the early detection of potenti ally serious conditions.164
Response : We have no reason to believe that appr opriately valuing se rvices for payment under the PFS by revising payment to reflect duplic ation in the TC of di agnostic cardiovascular and ophthalmology multiple services would negativ ely impact quality of care, be counterproductive to the goal of promoting preventive care, or limit patients’ access to medically reasonable and necessary imaging services, or di sproportionally affect ce rtain groups. We have no evidence to suggest any of the adverse impact s identified by the commenters have resulted from the implementation of the MPPR on the TC of imaging in 2006. In fact, to the contrary, the analysis in MedPAC’s June 2011 re port indicates there has been c ontinued high annual growth in the use of imaging. Further, it is worth not ing that, without any accompanying evidence of inadequate access or safety and quality concerns, declining growth in imaging services could be interpreted as a return to a more a ppropriate level of imaging utilization. For the ordering and scheduling of cardi ovascular or ophthalmology services for Medicare beneficiaries, we requi re that Medicare-covered services be appropriate to beneficiary needs. We would not expect the adoption of an MPPR for the TC of diagnostic cardiovascular and ophthalmology services to result in serv ices being furnished on separate days by one physician merely so that the physician may garn er increased payment. We agree with the commenters who noted that such an unprofessional response on th e part of practitioners would be inefficient and inappropriate care for the beneficiary. We will monitor access to care and patterns of delivery for cardiovascular and opht halmology services to beneficiaries, with particular attention focused on identifying any c linically inappropriate changes in timing of the delivery of such services. In summary, after considerat ion of the public comments re ceived, we are adopting our CY 2013 proposal to apply an MPPR to the TC of diagnostic cardiovascular and ophthalmology services, with a modification to apply a 20 percent reduction for diagnostic ophthalmology services rather than the 25 percent reduction we had propose d. The reduction percentage for165 diagnostic cardiovascular services remains at 25 percent, as proposed. We continue to believe that efficiencies exist in the TC of multip le diagnostic cardiovascular and ophthalmology services and we will continue to monitor code combinations for possible future adjustments to the reduction percentage app lied through this MPPR policy. Specifically, beginning in CY 2013 we ar e adopting an MPPR that applies a 25 percent reduction to the TC of second and subsequent diagnostic cardiovascular, and a 20 percent reduction to the TC of second and subsequent diagnostic ophthalmology services, furnished by the same physician (or physicians in the same group practice) to the sa me beneficiary , on the same day. In Table 10, we provide examples illustrating the current and CY 2013 payment

amounts: TABLE 10: Illustration of Current and CY 2013 Payments Sample Cardiovascular Payment Reduction * Code Code Total Current Total CY 2013 Payment 78452 93306 Payment Payment Calculation PC $77.00 $65.00 $142.00 $142.00 no reduction TC $427.00 $148.00 $575.00 $538.00 $427 + (.75 x $148) Global $504.00 $213.00 $717.00 $680.00 $142 + $427 + (.75 x $148) Sample Ophthalmology Payment Reduction * Code Code Total Current Total CY 2013 Payment 92235 92250 Payment Payment Calculation PC $46.00 $23.00 $69.00 $69.00 no reduction TC $92.00 $53.00 $145.00 $134.40 $92 + (.80 x $53) Global $138.00 $76.00 $214.00 $203.40 $69 + $92 + (.80 x $53) *Dollar amounts are for illust rative purposes and do not re flect actual payment amounts.
No changes have been made to the propos ed list for diagnostic ophthalmology services. We have revised the proposed list for diagnos tic cardiovascular services by removing codes deleted for CY 2013, add-on codes, and remote monitoring codes, and adding global codes corresponding to technical-only codes already on the list:166
TABLE 11: Changes to the Proposed List of Procedures Subject to the MPPR on Diagnostic Cardiovascular Services

Code Descriptor Added/Deleted Reason 75650 Artery x-rays head & neck Deleted Deleted for CY 2013 75660 Artery x-rays head & neck Deleted Deleted for CY 2013 75662 Artery x-rays head & neck Deleted Deleted for CY 2013 75665 Artery x-rays head & neck Deleted Deleted for CY 2013 75671 Artery x-rays head & neck Deleted Deleted for CY 2013 75676 Artery x-rays neck Deleted Deleted for CY 2013 75680 Artery x-rays neck Deleted Deleted for CY 2013 75685 Artery x-rays spine Deleted Deleted for CY 2013 75774 Artery x-ray each vessel Deleted Add-on Code 78496 Heart first pass add-on Deleted Add-on Code 93000 Electrocardiogram complete Added Global Code 93015 Cardiovascular stress test Added Global Code 93040 Rhythm ECG with report Added Global Code 93224 Ecg monit/reprt up to 48 hrs Added Global Code 93268 ECG record/review Added Global Code 93293 Pm phone r-strip device eval Deleted Remote monitoring code
93296 Pm/icd remote tech serv Deleted Remote monitoring code 93320 Doppler echo exam heart Deleted Add-on Code 93321 Doppler echo exam heart Deleted Add-on Code 93325 Doppler color flow add-on Deleted Add-on Code 93784 Ambulatory BP monitoring Added Global Code

The complete list of services subject to the MPPR for the TC of diagnostic cardiovascular and ophthalmology services is sh own in Addendum X. The PFS budget neutrality provision is applicable to th e new MPPR for the TC of diagnostic cardiovascular and ophthalmology services. Therefore, the estimated reduced expenditures for such services have been redistributed to increase payment for other PFS services. We refer readers to section VIII.C. of this final rule with comment period for fu rther discussion of the impact of this policy. TABLE 12: Diagnostic Cardiovascular Services Subject to the Multiple Procedure Payment Reduction167
Code Short Descriptor 75600 Contrast x-ray exam of aorta 75605 Contrast x-ray exam of aorta 75625 Contrast x-ray exam of aorta 75630 X-ray aorta leg arteries 75658 Artery x-rays arm 75705 Artery x-rays spine 75710 Artery x-rays arm/leg 75716 Artery x-rays arms/legs 75726 Artery x-rays abdomen 75731 Artery x-rays adrenal gland 75733 Artery x-rays adrenals 75736 Artery x-rays pelvis 75741 Artery x-rays lung 75743 Artery x-rays lungs 75746 Artery x-rays lung 75756 Artery x-rays chest 75791 Av dialysis shunt imaging 75809 Nonvascular shunt x-ray 75820 Vein x-ray arm/leg 75822 Vein x-ray arms/legs 75825 Vein x-ray trunk 75827 Vein x-ray chest 75831 Vein x-ray kidney 75833 Vein x-ray kidneys 75840 Vein x-ray adrenal gland 75842 Vein x-ray adrenal glands 75860 Vein x-ray neck 75870 Vein x-ray skull 75872 Vein x-ray skull 75880 Vein x-ray eye socket 75885 Vein x-ray liver 75887 Vein x-ray liver 75889 Vein x-ray liver 75891 Vein x-ray liver 75893 Venous sampling by catheter 78428 Cardiac shunt imaging 78445 Vascular flow imaging 78451 Ht muscle image spect sing 78452 Ht muscle image spect mult 78453 Ht muscle image planar sing 78454 Ht musc image planar mult 78456 Acute venous thrombus image 78457 Venous thrombosis imaging168
Code Short Descriptor 78458 Ven thrombosis images bilat 78466 Heart infarct image 78468 Heart infarct image (ef) 78469 Heart infarct image (3D) 78472 Gated heart planar single 78473 Gated heart multiple 78481 Heart first pass single 78483 Heart first pass multiple 78494 Heart image spect 93000 Electrocardiogram complete 93005 Electrocardiogram tracing 93015 Cardiovascular stress test 93017 Cardiovascular stress test 93024 Cardiac drug stress test 93025 Microvolt t-wave assess 93040 Rhythm ECG with report 93041 Rhythm ecg tracing 93224 Ecg monit/reprt up to 48 hrs 93225 Ecg monit/reprt up to 48 hrs 93226 Ecg monit/reprt up to 48 hrs 93229 Remote 30 day ecg tech supp 93268 ECG record/review 93270 Remote 30 day ecg rev/report 93271 Ecg/monitoring and analysis 93278 ECG/signal-averaged 93279 Pm device progr eval sngl 93280 Pm device progr eval dual 93281 Pm device progr eval multi 93282 Icd device prog eval 1 sngl 93283 Icd device progr eval dual 93284 Icd device progr eval mult 93285 Ilr device eval progr 93286 Pre-op pm device eval 93287 Pre-op icd device eval 93288 Pm device eval in person 93289 Icd device interrogate 93290 Icm device eval 93291 Ilr device interrogate 93292 Wcd device interrogate 93303 Echo transthoracic 93304 Echo transthoracic 93306 Tte w/doppler complete 93307 Tte w/o doppler complete 93308 Tte f-up or lmtd169
Code Short Descriptor 93312 Echo transesophageal 93314 Echo transesophageal 93318 Echo transesophageal intraop 93350 Stress tte only 93351 Stress tte complete 93701 Bioimpedance cv analysis 93724 Analyze pacemaker system 93784 Ambulatory BP monitoring 93786 Ambulatory BP recording 93788 Ambulatory BP analysis 93880 Extracranial study 93882 Extracranial study 93886 Intracranial study 93888 Intracranial study 93890 Tcd vasoreactivity study 93892 Tcd emboli detect w/o inj 93893 Tcd emboli detect w/inj 93922 Upr/l xtremity art 2 levels 93923 Upr/lxtr art stdy 3+ lvls 93924 Lwr xtr vasc stdy bilat 93925 Lower extremity study 93926 Lower extremity study 93930 Upper extremity study 93931 Upper extremity study 93965 Extremity study 93970 Extremity study 93971 Extremity study 93975 Vascular study 93976 Vascular study 93978 Vascular study 93979 Vascular study 93980 Penile vascular study 93981 Penile vascular study 93990 Doppler flow testing TABLE 13: Diagnostic Ophthalmology Servi ces Subject to the Multiple Procedure Payment Reduction Code Descriptor

76510 Ophth us b & quant a 76511 Ophth us quant a only 76512 Ophth us b w/non-quant a 76513 Echo exam of eye water bath 76514 Echo exam of eye thickness 76516 Echo exam of eye170
Code Descriptor

76519 Echo exam of eye 92025 Corneal topography 92060 Special eye evaluation 92081 Visual field examination(s) 92082 Visual field examination(s) 92083 Visual field examination(s) 92132 Cmptr ophth dx img ant segmt 92133 Cmptr ophth img optic nerve 92134 Cptr ophth dx img post segmt 92136 Ophthalmic biometry 92228 Remote retinal imaging mgmt 92235 Eye exam with photos 92240 Icg angiography 92250 Eye exam with photos 92265 Eye muscle evaluation 92270 Electro-oculography 92275 Electroretinography 92283 Color vision examination 92284 Dark adaptation eye exam 92285 Eye photography 92286 Internal eye photography TABLE 14: Frequently Billed Diagno stic Cardiovascular Combinations Code Range 75600-75893 Code Descriptor Code Descript or Code Descriptor Code Des c 75710 Artery x-rays arm/leg 75791 Av dialysis shunt imaging 75625 Contrast x-ray exam of aorta 75716 Artery x-rays arms/legs 75625 Contrast x-ray exam of aorta 75716 Artery x-rays arms/legs 75774 Artery x-ray each vessel 75820 Vein x-ray arm/leg 75827 Vein x-ray chest 75625 Contrast x-ray exam of aorta 75710 Artery x-rays arm/leg 75791 Av dialysis shunt imaging 75827 Vein x-ray chest 75658 Artery x-rays arm 75791 Av dialysis shunt imaging 75820 Vein x-ray arm/leg 75827 Vei n ches t 75710 Artery x-rays arm/leg 75774 Artery x-ray each vessel 75820 Vein x-ray arm/leg 93931 Upper extremity study 75791 Av dialysis shunt imaging 75820 Vein x-ray arm/leg Code Range 78414-78496171
Code Descriptor Code Descript or Code Descriptor Code Des c 78452 Ht muscle image spect mult 93306 Tte w/doppler complete 78452 Ht muscle image spect mult 93017 Cardiovascular stress test 78452 Ht muscle image spect mult 93306 Tte w/doppler complete 93880 Extracranial study 78452TC Ht muscle image spect mult 93017 Cardiovascular stress test 78452 Ht muscle image spect mult 93880 Extracranial study 78452TC Ht muscle image spect mult 93306 Tte w/doppler complete 78452 Ht muscle image spect mult 93017 Cardiovascular stress test 93306 Tte w/doppler complete 78451 Ht muscle image spect sing 93306 Tte w/doppler complete 78452TC Ht muscle image spect mult 93306TC Tte w/doppler complete 78452 Ht muscle image spect mult 93306 Tte w/doppler complete 93880 Extracranial study 93978 Vas c stud y Code Range 93000-93990 Code Descriptor Code Des criptor Code Descriptor 93306 Tte w/doppler complete 93880 Extracranial study 93320 Doppler echo exam heart 93325 Lower extremity study 93351 Stress tte complete 93922 Upr/l xtremity art 2 levels 93925 Lower extremity study 93923 Upr/lxtr art stdy 3+ lvls 93925 Lower extremity study 93306TC Tte w/doppler complete 93880TC Extracranial study 93880 Extracranial study 93978 Vascular study 93284 Icd device progr eval mult 93290 Icm device eval 93922 Upr/l xtremity art 2 levels 93926 Lower extremity study 93965 Extremity study 93970 Extremity study 93925 Lower extremity study 93970 Extremity study

TABLE 15: Frequently Billed Diagno stic Ophthalmology Combinations Code Range 76510-76529 Code Descriptor Code Des criptor Code Descriptor 76514 Echo exam of eye thickness 92133 Cmptr ophth img optic nerve172
76514 Echo exam of eye thickness 92083 Visual field examination(s) 92133 Cmptr ophth img optic nerve 76514 Echo exam of eye thickness 92083 Visual field examination(s) 76514 Echo exam of eye thickness 92250 Eye exam with photos 76514 Echo exam of eye thickness 92083 Visual field examination(s) 92250 Eye exam with photos76512 Ophth us b w/nonquant a 92134 Cptr ophth dx img post segmt76512 Ophth us b w/nonquant a 92250 Eye exam with photos 76514 Echo exam of eye thickness 92286 Internal eye photography 76514 Echo exam of eye thickness 92134 Cptr ophth dx img post segmt76512 Ophth us b w/nonquant a 92235 Eye exam with photos 92250 Eye exam with photos Code Range 92002-92371 Code Descriptor Code Des criptor Code Descriptor 92083 Visual field examination(s) 92133 Cmptr ophth img optic nerve 92235 Eye exam with photos 92250 Eye exam with photos 92083 Visual field examination(s) 92250 Eye exam with photos
92083 Visual field examination(s) 92134 Cptr ophth dx img post segmt 92134 Cptr ophth dx img post segmt 92235 Eye exam with photos 92134 Cptr ophth dx img post segmt 92250 Eye exam with photos 92134 Cptr ophth dx img post segmt 92235 Eye exam with photos 92250 Eye exam with photos 92250 Eye exam with photos 92285 Eye photography 92082 Visual field examination(s) 92250 Eye exam with photos
92081 Visual field examination(s) 92285 Eye photography

d. Procedures Subject to the OPPS Cap We are proposing to add the new codes in Ta ble 16 to the list of pr ocedures subject to the OPPS cap, effective January 1, 2013. Some of these codes are replacement codes for codes deleted for CY 2013. These procedures meet th e definition of imaging under section 5102(b) of173 the DRA. These codes are being added on an interi m final basis and their addition as procedures subject to the OPPS cap is open to public comment in this final rule with comment period.
TABLE 16: Additions and Deletions to the Li st of Procedure Subject to the OPPS CAP on Imaging Services
ADDITIONS DELETIONS Code Descriptor Code Descriptor 31620 Endobronchial us add-on 71040 Contrast x-ray of bronchi 36221 Place cath thoracic aorta 71060 Contrast x-ray of bronchi 36222 Place cath carotd/inom art 75650 Artery x-rays head & neck 36223 Place cath carotd/inom art 75660 Artery x-rays head & neck 36224 Place cath carotd art 75662 Artery x-rays head & neck 36225 Place cath subclavian art 75665 Artery x-rays head & neck 36226 Place cath vertebral art 75671 Artery x-rays head & neck 36227 Place cath xtrnl carotid 75676 Artery x-rays neck 36228 Place cath intracranial art 75680 Artery x-rays neck 43206 Esoph optical endomicroscopy 75685 Artery x-rays spine 43252 Upper GI optical endomicroscopy 75900 Intravascular cath exchange 77080 DXA bone density axial 75961 Retrieval broken catheter 77082 DXA bone density vert fx 77424 Intraoperative radiation delivery 78013 Thyroid imaging w/ blood flow 78006 Thyroid imaging with uptake 78014 Thyroid imaging w/ blood flow 78007 Thyroid image mult uptakes 78070 Parathyroid planar imaging 78010 Thyroid imaging 78071 Parathyroid planar imaging w/o subtrj 78011 Thyroid imaging with flow 78072 Parathyroid imaging w/ spect & ct 88375 Optical endomicroscopy interp 91110 GI tract capsule endoscopy 91111 Esophageal capsule endoscopy 92287 Internal eye photography C. Overview of the Methodology for the Calculation of Malpractice RVUs Section 1848(c) of the Act requi res that each service paid under the PFS be comprised of three components: work, PE, and malpractic e. From 1992 to 1999, malpractice RVUs were charge-based, using weighted specialty-specific malpracti ce expense percentages and 1991 average allowed charges. Malp ractice RVUs for new codes afte r 1991 were extrapolated from similar existing codes or as a percentage of th e corresponding work RVU. Section 4505(f) of the174 BBA, which amended section 1848(c) of the Act, required us to implement resource-based malpractice RVUs for services furnished beginni ng in 2000. Therefore, initial implementation of resource-based malpracti ce RVUs occurred in 2000. The statute also requires that we review a nd, if necessary, adjust RVUs no less often than every 5 years. The first review and update of resource-based malpract ice RVUs was addressed in the CY 2005 PFS final rule with comment peri od (69 FR 66263). Minor modifications to the methodology were addressed in the CY 2006 PFS final rule with comment period (70 FR 70153). In the CY 2010 PFS final rule with comment period, we implemented the second review and update of malpractice RVUs. For a discussion of the second review and update of malpractice RVUs, see the CY 2010 P FS proposed rule (74 FR 33537) and final rule with comment period (74 FR 61758). As explained in the CY 2011 PFS final rule with comment period (75 FR 73208), malpractice RVUs for new and revised codes eff ective before the next Five-Year Review of Malpractice (for example, eff ective CY 2011 through CY 2014, assumi ng that the next review of malpractice RVUs occurs for CY 2015) are determ ined either by a direct crosswalk to a similar source code or by a modified crosswalk to acc ount for differences in work RVUs between the new/revised code and the source code. For the modified crosswalk appr oach, we adjust (or ‘‘scale’’) the malpractice RVU for the new/revised code to reflect the difference in work RVU between the source code and the new/revised work value (or, if greater, th e clinical labor portion of the fully implemented PE RVU) for the new code. For example, if the proposed work RVU for a revised code is 10 percent higher than th e work RVU for its source code, the malpractice RVU for the revised code would be increased by 10 percent over the source code malpractice RVU. This approach presumes the same risk f actor for the new/revised code and source code but uses the work RVU for the new/revise d code to adjust for risk-of-service. As we indicated in the CY 2013 PFS propos ed rule, we will continue our current175 approach for determining malpractice RVUs for ne w/revised codes. In section II.M.2. of this final rule with comment period, we have publ ished a list of new/re vised codes and the malpractice crosswalk(s) used for determini ng their malpractice RVUs. These malpractice RVUs for new/revised codes will be implemented for CY 2013 on an interim final basis and the malpractice crosswalks are subject to public comment. We will respond to comments and finalize the malpractice crosswalks for the major ity of these codes in the CY 2014 PFS final rule with comment period. D. Geographic Practice Cost Indices (GPCIs) 1. Background Section 1848(e)(1)(A) of the Act requires us to develop separate Geographic Practice Cost Indices (GPCIs) to measure resource cost differences among localities compared to the national average for each of the three fee schedule components (t hat is, work, practice expense (PE), and malpractice ). While re quiring that the PE and MP GPCIs reflect the full relative cost differences, section 1848(e)(1)(A)( iii) of the Act requires that the work GPCIs reflect only one-quarter of the relative cost differences compar ed to the national average. In addition, section 1848(e)(1)(G) of the Act sets a permanent 1.5 work GPCI floor for services furnished in Alaska beginning January 1, 2009, and section 1848(e)(1)(I) of the Act sets a permanent 1.0 PE GPCI floor for services furnished in fr ontier states beginning January 1, 2011. Section 1848 (e)(1)(E) of the Act provides for a 1.0 floor for the work GPCIs, which was set to expire at the end of 2011. The statute was amended by section 303 of the Temporary Payroll Tax Cut Continuation Act of 2011 (TPTCC A) (Pub. L. 112-78) to extend the 1.0 floor for the work GPCIs through February 29, 2012. The statute was again amended by section 3004 of the Middle Class Tax Relief and Job Crea tion Act of 2012 (MCTRJCA) (P.L. 112-399) to extend the 1.0 work floor for GPCIs throughout the remainder of CY 2012 (t hat is, for services furnished no later than December 31, 2012). Du ring the development of the CY 2012 PFS final176 rule with comment period, neither TPTCCA nor MCTRJCA had been enacted and, because the work GPCI floor was set to expire at the end of 2011, the GPCIs published in Addendum E of the CY 2012 PFS final rule with comment period did not reflect the 1.0 work floor. Following the enactment of the legislati on, appropriate changes to the CY 2012 GPCIs to reflect the 1.0 work floor required by section 303 of the TPTC CA and section 3004 of the MCTRJCA. Since the 1.0 work GPCI floor provided in section 1848 (e)(1)(E) of the Act is set to expire prior to the implementation of the CY 2013 updates to the PFS, the proposed CY 2013 work GPCIs and summarized geographic adjust ment factors (GAFs) published in addendums D and E of this CY 2013 PFS proposed rule do not reflect the 1.0 work GPCI floor for CY 2013. As required by section 1848 (e)(1 )(G) and section1848 (e )(1)(I) of the Act, the 1.5 work GPCI floor for Alaska and the 1.0 PE GPCI floor for fr ontier states are appli cable in CY 2013 and are reflected in addendums D and E. In the CY 2012 PFS final rule with comment period, we made several refinements to the GPCIs (76 FR 73081 through 73092), including re vising the sixth GPCI update to reflect the most recent data, with modifications. Specificall y, we finalized our proposal to change the GPCI cost share weights for CY 2012 to reflect the most recent rebased and revised Medicare Economic Index (MEI). As a result, the cost shar e weight for the work GPCI (as a percentage of the total) was changed from 52.466 percent to 48.266 percent, and the cost share weight for the PE GPCI was revised from 43.669 percent to 47.4 39 percent with a change in the employee compensation component from 18.654 to 19.153 percen tage points. The cost share weight for the office rent component of the PE GP CI was changed from 12.209 percent to 10.223 percentage points (fixed capital with utilities), and the medical equipment, supplies, and other miscellaneous expenses component was cha nged from 12.806 percent to 9.968 percentage points. In addition, we finalized the weight for purchased services at 8.095 percentage points, of which 5.011 percentage points are adjusted for ge ographic cost differences . Lastly, the cost177 share weight for the malpractice GPCI was revi sed from 3.865 percent to 4.295 percent. Table 17 displays the cost share weight s that were finalized in the CY 2012 final rule with comment period. Note that the employee compensation; office rent; purchased services; and equipment supplies and other cost share weights sum to the total PE GPCI cost share weights of 47.439 percent. TABLE 17: Cost Share Weights finalized in CY 2012 GPCI Update Expense Category Cost Share Weights % Work 48.266 Practice Expense 47.439 Employee Compensation 19.153 Office Rent 10.223 Purchased Services 8.095 Equipment, Supplies, and Other 9.968 Malpractice Insurance 4.295

We also finalized several other policies in the CY 2012 final rule with comment period including the use of 2006 through 2008 Americ an Community Survey (ACS) two-bedroom rental data as a proxy for the re lative cost difference in physician office rent. In addition, we created a purchased services i ndex to account for labor-related services within the “all other services” and “other professional expenses” MEI components. In response to public commenters who recommended that we use Bureau of Labor Statistics (BLS) Occupational Employment Statistics (OES) data to capture the “full rang e” of occupations included in the offices of physician industry to calculate the nonphysician em ployee wage component (also referred to as the employee wage index) of the PE GPCI, we fi nalized a policy of using 100 percent of the total wage share of nonphysician occupations in the offi ces of physicians' indus try to calculate the nonphysician employee wage component of the PE GPCI. 2. Recommendations from the Institute of Medicine178 Concurrent with our CY 2012 rulemaking cycle, the Institute of Me dicine released the final version of its first of two anticipated reports entitled “ Geographic Adjustment in Medicare Payment: Phase I: Improving Accuracy, Second Edition ” on September 28, 2011. This report included an evaluation of the accuracy of GAFs for the hospital wage index and the GPCIs, as well as the methodology and data used to calcul ate them. Several of the policies that we finalized in CY 2012 rulemaking addressed recommendations cont ained in the Institute of Medicine’s first report. Because we did not ha ve adequate time to completely address the Institute of Medicine’s Phase I report re commendations during CY 2012 rulemaking, we included a discussion in the CY 2013 proposed ru le (77 FR 44756) about the recommendations that were not implemented or discussed in th e CY 2012 final rule with comment period. As we anticipated in the CY 2013 proposed rule , the Institute of Medi cine’s second report, entitled “ Geographic Adjustment in Medi care Payment - Phase II: Implications for Access, Quality, and Efficiency, ” was released July 17, 2012. The Phase II report evaluates the effects of GAFs (hospital wage index and GPCIs) on the distribution of the healthcare workforce, quality of care, population health, and the ability to provide efficient, high value care. Once we have had an opportunity to fully evaluate the report a nd its recommendations we will respond to its recommendations in subsequent rulemaking. 3. GPCI Discussion for CY 2013 CY 2013 is the final year of the sixth GP CI update and, because we will propose updates next year, we did not include any proposals related to the GP CIs for the CY 2013 PFS. In response to public inquiries a bout exceptions to the calculate d GPCIs, we provided a brief discussion about the permanent 1.0 PE floor for fr ontier states, the 1.5 work floor for Alaska, the GPCIs for the Puerto Rico payment locality, a nd the expiration of the GPCI 1.0 work floor required under section 1848 (e)(1)(E ) of the Act. We also discussed recommendations from the179 first Institute of Medicine repor t that were not addressed duri ng CY 2012 rulemaking in the CY 2013 proposed rule. We have incl uded this discussion below. a. Alaska Work Floor and PE GPCI Floor for Frontier States Section 1848(e)(1)(G) of the Act sets a pe rmanent 1.5 work GPCI floor for services furnished in Alaska beginning January 1, 2009. Th erefore, the 1.5 work floor for Alaska will remain in effect in CY 2013. In addition, sec tion 1848(e) (1)(I) of the Act establishes a 1.0 PE GPCI floor for physicians' services furnished in frontier states effective January 1, 2011. In accordance with section 1848(e)(1)(I) of the Ac t, beginning in CY 2011, we applied a 1.0 PE GPCI floor for physicians’ services furnished in states determined to be frontier states. The following states met the statutory criteria to be considered frontie r states for CY 2012: Montana, North Dakota, Nevada, South Dakota, and Wyom ing. There are no changes to those states identified as frontier states for CY 2013. b. GPCI Assignments for the Puerto Rico Payment Locality As noted in the CY 2013 proposed rule, we have received inquiries from representatives of the Puerto Rico medical community regardin g our policies for determining the GPCIs for the Puerto Rico payment locality. While we did not make any proposals related to the GPCIs for Puerto Rico, in response to those inquiries, we provided the following discussion regarding the GPCIs assigned to the Puerto Rico payment loca lity. We anticipate recalculating all the GPCIs in the seventh GPCI update, currently antic ipated to be implemented for CY 2014. As noted above, we are required by sect ion 1848(e)(1)(A) of th e Act to develop separate GPCIs to measure relative resource co st differences among localities compared to the national average for each of th e three fee schedule components: work, PE and malpractice expense. To calculate these GPCI values, we re ly on three primary data sources. We currently use the 2006-2008 BLS OES data to calculate the work GPCI, the nonphysician employee wage component of PE GPCI, and the labor costs associ ated with the purchased services component of180

PE GPCI. We use 2006-2008 ACS data to calculate the office rent component of the PE GPCI. Finally, we use 2006-2007 malpracti ce premium data to calculate th e malpractice GPCI. For all localities, including Puerto Rico, we assume equipment, supplies, and other expenses are purchased in a national market and that the co sts do not vary by geograp hic location. Therefore, we do not use data on the price of equipment, supplies, and expenses across localities in calculating PE GPCIs. With the exception of the malpractice GPCI, we have current data from the applicable sources allowing us to calculate the work and PE GPCIs for the Puerto Rico payment locality. The 2006-2008 BLS OES data and rental values derived from the 2006-2008 ACS indicate that the costs associ ated with operating a physician pr actice in Puerto Rico are the lowest among all payment localities. To calculate the malpractice GPCI for the various Medicare PFS localities, we collect malpractice insurance market share and premium data from state departments of insurance and from state rate filings. As discussed in our contractor’s report (Final Report on the Sixth Update of the Geographic Practice Cost Index for the Medicare Physician Fee Schedule page. 41), for the fourth, fifth, and sixth GPCI upd ates we were not able to collect this data for the Puerto Rico payment locality. Therefore, we carried over th e malpractice GPCI value of 0.249 from previous GPCI updates when malpractice premiu m data were last available. It is important to note that we have a source for more current malpractice pr emium data for Puerto Rico for use in the upcoming seventh GPCI update. We are working with the relevant officials in Puerto Rico to acquire these data for use in future rulemaking. For a detailed discussion regarding the methodology used to calculate the various components of the Puerto Rico GPCIs, we refe rred readers to our contractor’s report from November of 2010 entitled “Final Report on the Si xth Update of the Geographic Practice Cost Index for the Medicare Physician Fee Sc hedule” available on our website at www.cms.gov/PhysicianFeeSched/downloads/GPCI_Report.pdf

.181 In the CY 2013 proposed rule, we also encouraged comments from stakeholders regarding potential data sources that may be available for calc ulating the Puerto Rico malpractice
GPCI.
Comment : In response to our inquiry regarding pot ential sources for data that could be used in calculating a malprac tice GPCI for Puerto Rico, we received numerous comments about the costs of practicing medicine in Puerto Ri co. The commenters primarily expressed concern about the PE GPCI (with emphases on the rent component) and the malpractice GPCI. The commenters stated that the current GPCI values for Puerto Rico are low in comparison to other PFS localities and that this dispar ity may create incentives for doctors to move their practices to the continental United States. As a result, th e commenters explained that access to both primary and specialty care for Medicare beneficiaries resi ding in Puerto Rico could be compromised. Several stakeholders provided a re port on a comprehensive study entitled “ Cost of Medical Services in Puerto Rico. ” The report included results from a physician survey on the costs of operating a medical practice in Puerto Rico, including the cost for obtaining malpractice insurance. For example, the report included in formation about the leadin g malpractice insurers in Puerto Rico, the amount of malpractice insu rance coverage typically purchased by physicians, and the cost of malpractice insurance by primary and specialty care providers. In addition to malpractice insurance costs, the report also included information on the cost of employees, contracted services, rent and uti lities, medical equipment and supp lies in Puerto Rico as well as information on the major concerns, demographics , and work patterns of the doctors currently practicing medicine in Puerto Rico and the doc tors that have moved from Puerto Rico now practicing in the United States. Response : As noted in the proposed rule, we w ill be adjusting the GPCIs for CY 2014. Given that we did not make any proposals to modify the malpractice GPCI calculation methodology or values for CY 2013, it would not be appropriate to make changes to the GPCIs182 in this final rule. We appr eciate the physician survey informa tion on the cost of malpractice insurance. We will review the information submitted on the cost of obtaining malpractice insurance in Puerto Rico as we prepare for th e seventh GPCI update. We would note that the GPCIs are based upon changes in the relative costs of obtaining malpractice insurance so any changes in the GPCI for Puerto Rico will be based not only on data reflecting the costs on Puerto Rico, but also those in other localities. c. Expiration of GPCI Work Floor The work GPCIs are designed to capture the re lative costs of physician labor by Medicare PFS locality. Previously, the work GPCIs were developed using the median hourly earnings from the 2000 Census of workers in seven profes sional specialty occupation categories that we used as a proxy for physicians’ wages. Physicians’ wages are not included in the occupation categories because Medicare payments are a key determinant of physicians’ earnings. That is, including physicians’ wages in the work GPCIs would effectively make the indices dependent upon Medicare payments. As required by law, the wo rk GPCIs reflect one quarter of the relative wage differences for each locality compared to th e national average. The work GPCI updates in CYs 2001, 2003, 2005, and 2008 were based on prof essional earnings data from the 2000 Census. For the sixth GPCI update in CY 2011, we used the 2006 through 2008 BLS OES data as a replacement for the 2000 Census data. Although we did not propose any changes to the data or methodology used to calculate the work GPCI for CY 2013, we note that adde nda D and E will reflect the expiration of the statutory 1.0 work GPCI floor which as noted above, is set to expire on December 31, 2012 in accordance with section 1848 (e)(1)(E) of the Act.
Comment : A few commenters requested an extens ion of the 1.0 work GPCI floor stating that the statutorily-mandated work GP CI floor will expire on December 31, 2012.183
Response : As discussed above (and noted by th e commenters) the 1.0 work GPCI floor is set to expire on December 31, 2012 and we do not have authority to extend the 1.0 work GPCI floor beyond December 31, 2012. 4. Institute of Medicine Phase I Report a. Background At our request, the Institute of Medi cine conducted a study of the geographic adjustment factors in Medicare payment. It is a comprehensive empirical study of the geographic adjustment factors established under sections 1848(e) (GPCI) and 1886(d)(3)(E) (hospital wage index) of the Act. These adju stments are designed to en sure Medicare payments reflect differences in input costs across geographic areas. The factors the Institute of Medicine evaluated include the following:

● Accuracy of the adjustment factors;

● Methodology used to determin e the adjustment factors; and

● Sources of data and the degree to which such data are representative. Within the context of the U.S. healthcare marketplace, the Institute of Medicine also evaluated and considered the—

● Effect of the adjustment factors on the level and di stribution of the health care workforce and resources, including— ++ Recruitment and retention ta king into account mobility betw een urban and rural areas; ++ Ability of hospitals and othe r facilities to maintain an ad equate and skilled workforce; and ++ Patient access to providers a nd needed medical technologies;

● Effect of adjustment factors on popul ation health and qua lity of care; and

● Effect of the adjustment f actors on the ability of providers to furnish efficient, high value care.184

The Institute of Medicine ’s first report entitled “ Geographic Adjustment in Medicare Payment, Phase I: Improving Accuracy ” evaluated the accuracy of ge ographic adjustment factors and the methodology and data used to calculate them. The recommendations included in the Institute of Medicine’s Phase I re port that relate to or would have an effect on the methodologies used to calculate the GPCIs and the configuration of Medicare PFS payment locality structure are summarized as follows:

● Recommendation 2-1: The same labor mark et definition should be used for both the hospital wage index and the physician geographic adjustment factor. Metropolitan statistical areas and statewide non-metropolitan statistical areas should serve as the basis for defining these labor markets.

● Recommendation 2-2: The data used to construct the hospital wage index and the physician geographic adjustment factor shoul d come from all health care employers.

● Recommendation 5-1: The GPCI cost sh are weights for adjusting fee-for-service payments to practitioners should continue to be national, including the three GPCIs (work, PE, and liability insurance) and the categories w ithin the PE (office rent and personnel).

● Recommendation 5-2: Proxi es should continue to be used to measure geographic variation in the physician work adjustment, but CMS should determine whether the seven proxies currently in use should be modified.

● Recommendation 5-3: CMS should consider an alternative method for setting the percentage of the work adjustment ba sed on a systematic empirical process.

● Recommendation 5-4: The PE GPCI shoul d be constructed with the full range of occupations employed in physicians' offices, each w ith a fixed national weight based on the hours of each occupation employed in physicians' offices nationwide.

● Recommendation 5-5: CMS and the Bureau of Labor Statistic s should develop an agreement allowing the Bureau of Labor Statisti cs to analyze confidential data for CMS.185

● Recommendation 5-6: A new source of inform ation should be developed to determine the variation in the price of commerci al office rent per square foot.

● Recommendation 5-7: Nonclin ical labor-related expenses currently included under PE office expenses should be geographi cally adjusted as part of the wage component of the PE. This report can be accessed on the Institute of Medicine 's website at www.iom.edu/Reports/2011/Geographic-Adjustment -in-Medicare-Payment-Phase-I-Improving-Acc
uracy.aspx
. As previously noted in this section, the Institu te of Medicine also considered the role of Medicare payments on matters such as the dist ribution of the healthcare workforce, population health, and the ability of provide rs to produce high-value, high-qua lity health care in its final report July 17, 2012. We were not able to evaluate the recommendations contained in the Institute of Medicine’s Phase II re port, in time for discussion in the proposed rule. The Phase II report can be accessed on the Institute of Medicine’s website at www.iom.edu/Reports/2012/Geographic-Adjust ment-in-Medicare-Payment-Phase-II.aspx

. b. Institute of Medicine Recomme ndations Implemented in CY 2012 In the CY 2012 PFS final rule with comme nt period, we addressed three of the recommendations offered by the Institute of Medicine in its Phase I report. Specifically, the final CY 2012 GPCIs utilized the full range of nonphys ician occupations in the employee wage calculation consistent with Institute of Medici ne recommendation 5-4. Additionally, we created a new purchased service index to account for nonclinical labor related expenses similar to Institute of Medicine recommendation 5-7. Lastly, we have consistently us ed national cost share weights to determine the appropriate weight at tributed to each GPCI component, which is supported by Institute of Medicine recomme ndation 5-1 (76 FR 73081 through 73092). In order to facilitate a public discussion regarding th e Institute of Medicine’s remaining Phase I recommendations, we provided a summary analys is of these recommendations in the CY 2013186 proposed rule, which has also been included in th is final rule with comment period below. We provided our technical analyses of the remaining Institute of Medicine Phase I recommendations in a report released on the PFS website at www.cms.gov/PhysicianFeeSched . Since we have not yet had an opportunity to review the recommenda tions in the Institute of Medicine’s Phase II report, these analyses focus exclusively on the re commendations as presented in the Institute of Medicine’s Phase I report. c. Discussion of Remaining Institute of Medicine’s Phase I recommendations (1) Institute of Medicine Recommendation Summaries (A) Institute of Medicine recommendation 2-1 : The same labor market definition should be used for both the hospital wage index and th e physician geographic adjustment factor. Metropolitan statistical areas a nd statewide non-metropolitan statisti cal areas should serve as the basis for defining these labor markets. (Geographi c Adjustment in Medicare Payment, Phase I: Improving Accuracy pages 2-1 thru 2-29) (i) Locality Background The current PFS locality structure was deve loped and implemented in 1997. There are currently 89 total PFS locali ties; 34 localities are stat ewide areas (that is, only one locality for the entire state). There are 52 localities in the othe r 16 states, with 10 states having 2 localities, 2 states having 3 localities, 1 state having 4 localitie s, and 3 states having 5 or more localities. The District of Columbia, Maryland, and Virginia subu rbs, Puerto Rico, and the Virgin Islands are additional localities that make up the remainder of the total of 89 localities. The development of the current locality structure is described in detail in the CY 1997 PFS proposed rule (61 FR 34615) and the subsequent final rule with comment period (61 FR 59494). Prior to 1992, Medicare payments for physicians’ services were made under the reasonable charge system. Payments were base d on the charging patterns of physicians. This resulted in large differences among types of se rvices, geographic payment areas, and physician187 specialties. Recognizing this, the Congress repl aced the reasonable char ge system with the Medicare PFS in the Omnibus Budget Rec onciliation Act (OBRA) of 1989, effective January 1, 1992. Payments under th e fee schedule are based on th e relative resources used in furnishing services and vary among areas as reso urce costs vary geographically as measured by the GPCIs. Payment localities were established unde r the reasonable char ge system by local Medicare carriers based on thei r knowledge of local physician charging patterns and economic conditions. These localities changed little betw een the inception of Me dicare in 1967 and the beginning of the PFS in 1992. As a result, a study was begun in 1994 that resulted in a comprehensive locality revision, which was implemented in 1997 (61 FR 59494). The revised locality structure reduced the num ber of localities from 210 to the current 89 and the number of statewide locali ties increased from 22 to 34. Th e revised localities were based on locality resource cost differences as reflec ted by the GPCIs. A full discussion of the methodology can be found in the CY 1997 PFS fina l rule with comment period (61 FR 59494). The current 89 fee schedule areas are defined alternatively by state bounda ries (for example, Wisconsin), metropolitan areas (for example, Metropolitan St. Louis, MO), portions of a metropolitan area (for example, Manhattan), or rest -of-state areas that exclude metropolitan areas (for example, Rest of Missouri). This locality configuration is used to calculate the GPCIs that are in turn used to calculate paymen ts for physicians’ services under the PFS. As was stated in the CY 2011 final rule with comment period (75 FR 73261), we require that changes to the PFS locality struct ure be done in a budget neutral manner within a state. For many years, we have sought consensus for any locality changes among the professionals whose payments would be affected. We have also considered more comprehensive changes to locality configurations. In 2008, we issued a draft comprehensive report detailing four different locality configuration options188 ( www.cms.gov/physicianfeesched/downloads/ReviewOfAltGPCIs.pdf ). The alternative locality configurations in the report are described below.

● Option 1: CMS Core-Based Statistical Area (CBSA) Payment Lo cality Configuration : CBSAs are a combination of Office of Ma nagement and Budget (OMB’s) Metropolitan Statistical Areas (MSAs) and th eir Micropolitan Sta tistical Areas. Unde r this option, MSAs would be considered as urban CBSAs. Micropolitan Statistical Areas (as defined by OMB) and rural areas would be considered as non-urban (rest of state) CBSAs. This approach would be consistent with the areas used in the Inpa tient Prospective Payment System (IPPS) prereclassification wage index, which is the hospi tal wage index for a geographic area (CBSA or non-CBSA) calculated from submitted hospital cost report data before statutory adjustments reconfigure, or “reclassify” a hospital to an area other than it s geographic location, to adjust payments for difference in local resource costs in other Medicare payment systems. Based on data used in the 2008 locality report, this opt ion would increase the number of PFS localities from 89 to 439.

● Option 2: Separate High-Cost Counties from Existing Localitie s (Separate Counties) : Under this approach, higher cost counties are re moved from their existing locality structure, and they would each be placed into their own locality. This optio n would increase the number of PFS localities from 89 to 214, using a 5 percent GAF differential to separate high-cost counties.

● Option 3: Separate MSAs from Statewide Localities (Separate MSAs) : This option begins with statewide localities and creates separate localities fo r higher cost MSAs (rather than removing higher cost counties from their existing locality as descri bed in Option 2). This option would increase the number of PFS localities from 89 to 130, using a 5 percent GAF differential to separate high-cost MSAs.

● Option 4: Group Counties Within a St ate Into Locality Ti ers Based on Costs (Statewide Tiers) : This option creates tiers of counties (within each state) that may or may not189 be contiguous but share similar practice costs. This option would increase the number of PFS localities from 89 to 140, using a 5 percent GAF differential to group similar counties into statewide tiers. For a detailed discussion of the public comm ents on the contractor ’s 2008 draft report detailing four different localit y configurations, we refer read ers to the CY 2010 PFS proposed rule (74 FR 33534) and subsequent final rule with comment period (74 FR 61757). There was no public consensus on the options, although a numb er of commenters expressed support for Option 3 (separate MSAs from statewide locali ties) because the commenters believed this alternative would improve payment accuracy and could mitigate potential reductions to rural areas compared to Option 1 (CMS CBSAs). In response to some public comments regardi ng the third of the four locality options, we had our contractor conduct an analysis of the impacts that would result from the application of Option 3. Those results were displayed in the fi nal locality report released in 2011. The final report, entitled “ Review of Alternative GPCI Paymen t Locality Structures – Final Report, ” may be accessed directly from the CMS website at www.cms.gov/PhysicianFeeSched/downloads/Alt_ GPCI_Payment_Locality_Structures_Review. pdf

. (ii) Institute of Medicine Recommenda tions on PFS Locality Structure Discussion The Institute of Medicine recommends alte ring the current locality structure that was originally based on areas set by local contractors a nd, in 1996, reduced from 210 to current 89 using a systematic iterative methodology. Rather than using the current uniform fee schedule areas in adjusting for relative cost differences as compared to the national average, the Institute of Medicine recommends a three-ti ered system for defining fee sche dule areas. In the first tier, the Institute of Medicine propos es applying county-based fee sc hedule areas to calculate the employee wage component of the PE GPCI. Alt hough the Institute of Medicine’s report states190 that it recommends that “Metropolitan statisti cal areas and statewide non-metropolitan statistical areas should serve as the basis for defining these labor markets,” the Instit ute of Medicine also recommends applying an out-commuting adjustme nt, which would permit employee wage index values to vary by county. Since the employee wage index is one component of the PE GPCI, these values also would vary by county under the Institute of Medicine’s proposal. To understand why the employee wage index w ould vary by county und er the Institute of Medicine’s recommendation, consider the three st eps that would be required to calculate the employee wage index. The first step calculate s the average hourly wage (AHW) for workers employed in each MSA or residual (rest of state) area. The wages of workers in each occupation are weighted by the number of workers employe d in physicians’ offices nationally. The second step applies a commuting-based smoothing adjust ment to create area index wages for each county. The commuting-adjusted county index wages are equal to a weighted average of the AHW values calculated in the first step, wher e the weights are county-to-MSA out-commuting patterns. The Institute of Me dicine’s out-commuting-based wei ghts equal the share of health care workers that live in a count y where a physician’s office is located who commute out of the county to work in a physician’s office in each MSA. The third step sets each physician’s employee index wage equal to the estimated area i ndex wage (calculated in Step 2) of the county in which the physician’s office is located. B ecause the out-commuting adjustment envisioned by the Institute of Medicine in the second step varies by county, the employee wage index value— and thus the PE GPCI as a whole — would al so potentially vary by county depending on the smoothing option chosen. If implemented, the nu mber of employee wage index payment areas could potentially increase from 89 to over 3,000. The Institute of Medicine’s second tier of fee schedule ar eas would use an MSA-based approach. The Institute of Medicine proposes using the MSA-based system for the work GPCI, the office rent index and the purchased services index of the PE GPCI, and the MP GPCI. An191 MSA is made up of one or more counties, includi ng the counties that contai n the core urban area with a population of 50,000 or more, as well as surrounding counties that e xhibit a high degree of social and economic integration (as measured by commuting patterns) with the urban core. MSAs are designed to be socially and economi cally integrated units based on the share of workers who commute to work within the urba n core of each MSA. Implementing an MSAbased locality structure would expand the number of fee schedule areas from 89 to upwards of 400 plus additional MSAs for U.S. territories (f or example, Virgin Islands, American Samoa, Guam, Northern Marianna Islands). In its third payment area tier, the Instit ute of Medicine propos es creating a national payment area for the “equipment, supplies and ot her” index. We currently do not adjust PEs associated with supplies and equipment since we believe they are typically purchased in a national market. Thus, this approach is equivalent to using a national fee schedule area to define this index. The Institute of Medicine proposes no change to the fee schedule area used to compute the “equipment, supplies and other” index. Based on our contractor’s analysis, there woul d be significant redistri butive impacts if we were to implement a policy that would reconfi gure the PFS localities base d on the Institute of Medicine’s three-tiered recommendation. Many ru ral areas would see substantial decreases in their corresponding GAF and GPCI values as hi gher cost counties are removed from current “rest of state” payment areas. Conversely, many urban areas, especially those areas that are currently designated as “rest of state” but resi de within higher cost MSAs, would experience increases in their applicable GPCIs and GAFs. The localities used to calculate the GPCIs ha ve been a subject of substantial discussion and debate since the implementation of the PFS. The intensity of those discussions has increased since the last comprehensive update to the loca lity structure in 1997. Physicians and other suppliers in areas such as Santa Cruz County, California and Prince William County, Virginia192 have expressed concern that th e current locality structure does not appropriately capture economic and demographic shifts that have ta ken place since the last PFS locality update. On the other hand, rural practitioners have argued that revisions to the current PFS payment localities will reduce their paym ents and exacerbate the problem s of attracting physicians and other practitioners to rural areas. In the past, we have also hear d concerns from representatives of some statewide loca lities regarding the poten tial implications of adopting an alternative locality structure that would change their current statewide payment area (74 FR 33536). The Institute of Medicine stated in its Phase I report regarding its locality recommendation that, “While the payment areas woul d stay the same for the HWI (hospital wage index), implementing this recommendation woul d mean that the GPCI payment areas would expand from 89 to 441 areas, which would be a signi ficant change. The impact of the change in payment areas will be assessed in the Phase II report.” (“Geographic Adjustment in Medicare Payment: Phase I: Improving Accuracy, S econd Edition” on September 28, 2011 page 5-6

. ) Moreover, the Institute of Medi cine’s Phase II report will eval uate the effects of geographic adjustment factors on the distribution of the h ealthcare workforce, quality of care, population health, and the ability to provide efficient, high value care. Over the years, commenters that have opposed revisions to localities have claime d that changes to the PFS areas could have a significant impact on the ability of rural areas to attract physicians. Certainly, one of our major goals when we last comprehensively revised th e Medicare PFS localities in 1996 was to avoid excessively large urban/rural payment differences (61 FR 59494). In 1996, we were hopeful that the revisions would improve access to care for ru ral areas (61 FR 59494). Some areas may have experienced both economic and demographic shifts since the last comprehensive locality update. Before moving forward with the Institute of Medi cine’s three-tiered lo cality recommendation, or any other potential locality revi sion, we would need to assess, and prepare to inform the public of, the impact of any change for all Medicare stakeholders. The In stitute of Medicine’s Phase II193 report, released July 17, 2012, contains an eval uation of many of these important factors including:

● The effect of the adjustme nt factors on the level and di stribution of the health care workforce and resources, including-- ++ Recruitment and retention taking into account mobility between urban and rural

areas; ++ Ability for hospitals and other faciliti es to maintain an adequate and skilled workforce; ++ Patient access to providers a nd needed medical technologies; ++ Effect of adjustment factors on popul ation health and qu ality of care; and ++ Effect of adjustment factors on the ability of providers to furnis h efficient, high value

care. To fully assess the broader public policy impli cations associated w ith the Institute of Medicine’s locality recomme ndation, we must first fully assess and analyze the recommendations contained in the Institute of Medicine’s Phase II report. Accordingly, we believe that it would be premat ure to make any statements a bout potential changes we would consider making to the PFS localities at this ti me. Any changes to PFS fee schedule areas would be made through future notice and comment rulemaking. In the event that we devel op a specific proposal for changi ng the locality configuration during future rulemaking, we would provide detaile d analysis on the impact of the changes for physicians in each county. We would also prov ide opportunities for public input (for example, Town Hall meetings or Open Door Forums), as well as opportunities for public comments afforded by the rulemaking process. While we did not propose to change the cu rrent locality configur ation for CY 2013, we requested public comments regarding the Instit ute of Medicine’s recommended three-tiered PFS194 payment locality definition. In addition, as stated above we, made our technical analyses of the Institute of Medicine locality recommendations, specific to the Phase I report, available on the CMS website at www.cms.gov/PhysicianFeeSched/

. The following is a summary of the comments we received regarding the Institute of Medicine’s recommended three-tier ed PFS payment locality definition.
Comment : We received several comments on the Institute of Medicine’s recommendation for a three-tiered PFS payment lo cality definition. Commenters from rural areas opposed increasing the number of paymen t localities, as would happen under an MSAbased PFS locality structure, because it would redist ribute payments from rural to urban areas. Additionally, commenters who opposed the Institute of Medicine’s three-tie red locality approach argued that increasing the num ber of PFS payment localities would reduce their payment amounts and exacerbate problems of attracting physic ians and other practitioners to rural areas. A few commenters supported the Institute of Medicine’s recommendation to move toward an MSA-based locality configuration a nd urged us to make updating the PFS locality configuration a priority in CY 2013. Comm enters supporting an MSA-based locality configuration contend that significant economic and demographi c shifts have occurred since the last reconfiguration, making th e current locality assignments outdated. One state medical association expressed disappointme nt that we did not propose an MSA-based locality structure for CY 2013. The commenter urged us “to adopt a transition plan to update the PFS localities” and stressed that the “transition plan must take into account th e negative impact on physicians practicing in rural areas and work to m itigate the reductions in these regions.” Response : We appreciate the comments recei ved on the Institute of Medicine’s recommendation to adopt an MSA-based approach for defining PFS localities. We will continue to evaluate the comments received on the Inst itute of Medicine’s recommendations for revising195 the PFS locality structure, along with the impacts of such recommendations as discussed in the Phase II report. (B) Institute of Medicine Recommendation 2-2 : Employee Wage Index of the PE GPCI The data used to construct the hospital wage index and the physician geographic adjustment factor should come from all healthcare employers (Geograp hic Adjustment in Medicare Payment, Phase I: Improving Accuracy pages 2- 1 thru 2-29) and Recommendation 5-5: CMS and the Bureau of Labor Statisti cs should develop an agreement allowing the Bureau of Labor Statistics to analyze confidenti al data for the Centers for Me dicare and Medicaid Services. (Geographic Adjustment in Medicare Payment, Phase I: Improving Accuracy page 5-38.) The Institute of Medicine recommends alte ring the data used to calculate the employee wage index. Specifically, Institut e of Medicine recommends using wage data for workers in the healthcare industry rather than wa ge data for workers across all-i ndustries. Although all-industry wage data has the largest sample size, the Inst itute of Medicine “...is concerned that the [allindustry] sample does not represent physician offices.” BLS OES occupation wage data by MSA, however, are not publicly available for the healthcare industry. Usi ng healthcare-industry wages would require the use of confidential BLS OES data. While CMS could potentially secure access to the confidential BLS OES data, the gene ral public may not be able to. Although the Institute of Medicine recommends that CMS secure an agreement with BLS to use the confidential wage data, the current employee wage index relies on publicly -available all-industry wage data. In the CY 2013 proposed rule we request ed comments on the use of confidential employee wage index data rather than the publicly available all-industry wage data. However, we did not receive specific comments as to whether we should pursue the acquisition of confidential employee wage index data (as a replacement for the publically available all-industry wage data) for purposes of determining the em ployee wage index component of the PE GPCI.196 Regardless of whether healthcar e-industry or all-indus try wage data is used, the Institute of Medicine recommends following the curren t approach adopted by CMS in CY 2012 for calculating the employee wage index. This appr oach constructs the em ployee wage index as a weighted average of occupation wages for the fu ll-range of occupations employed in physicians’ offices, where the weights are equal to the fi xed national weight based on the hours of each occupation employed in physicians’ offices natio nwide. We adopted this approach for calculating the GPCI employee wage index in th e CY 2012 PFS final rule with comment period (76 FR 73088). (C) Institute of Medicine recommendation 5-2: Work GPCI Methodology Proxies should continue to be used to meas ure geographic variation in the physician work adjustment, but CMS should determine whether th e seven proxies currently in use should be modified (Geographic Adjustment in Medicare Payment, Phase I: Improving Accuracy page 5-36) and; Recommendation 5-3: CMS should c onsider an alternative method for setting the percentage of the work adjustment based on a systematic empirical process. (Geographic Adjustment in Medicare Payment, Phase I: Improving Accuracy pages 5-36 thru 5-37) The Institute of Medicine recommends replacing the current work GPCI methodology with a regression-based approach. We currently use three steps to calculate the work GPCI. These steps include: (1) Selecting the proxy occupations and calculating an occupationspecific index for each proxy;
(2) Assigning weights to each proxy-oc cupation index based on each occupation’s share of total national wa ges to create an aggregate proxyoccupation index; and197 (3) Adjusting the aggregate proxy- occupation index by a physician inclusion factor to calcula te the final work GPCI.
By using this approach, the current met hodology reduces the circularity problem that occurs when work GPCI values are based on direct measurements of physician earnings. Because physician earnings are made up of bot h wages and a return on investment from ownership of the physician practice, calculati ng the work GPCI using physician earnings information would assign areas where physician pract ices are more profitab le higher work GPCI values. Although the Institute of Medicine recommends that we continue to use proxy occupations in the work GPCI methodology, its regression-based a pproach alters each of the three steps described above. To modify the first step, the Institute of Medicine recommends that we empirically evaluate the validity of seven proxy occupati ons we currently use. The current proxy occupations in the work GPCI are intended to represent highly educate d, professional employee categories. Although the Institute of Medicine recommends re-evaluating the proxy occupations used in the work GPCI, it does not define sp ecific criteria to use for this purpose. To modify the second step, the Institute of Medicine recommends using a regressionbased approach to weight the selected proxy occ upation indices based on their correlation with physician earnings. This Institute of Medicine proposal would replace the current approach where occupations are weighted by the size of th eir share of total national wages. Such an approach presumes that wages for proxy occupa tions are not related to physician profits. Finally, the Institute of Medi cine proposes an empirically-b ased approach to determine the inclusion factor for work. The inclusion fa ctor for work refers to section 1848(e)(1)(A)(iii) of the Act requiring that the work GPCI reflect only 25 percent of th e difference between the relative value of physicians’ work effort in each locality and the national average of such work198
effort. Therefore, under current law, only one quarter of the measured regional variation in physician wages is incorporated into the work GPCI. The Institute of Medicine recommends calculating an inclusion factor ba sed on the predicted values of the regression described above. Under the Institute of Medicine’s approach, th e inclusion factor is larger when the proxy occupations have a higher correlation with phys icians’ earnings and smaller when the proxy occupations have a lower correlation with physicia ns’ earnings. We note that using such an empirical approach to weight the proxy occupati on indices and to estimate the inclusion factor requires the identificatio n of a viable source of physician wa ge information in addition to the wage information of proxy occupations to accura tely measure regional variation in physician
wages. We requested comments on the Institute of Medicine’s recommendations to revise the work GPCI methodology. The following is a summary of the comments we received regarding the Institute of Medicine’s recommendations to re vise the work GPCI methodology.
Comment : A few commenters stated that th e physician work GPCI should not be adjusted at all for geographic cost differences. However, the same commenters stated that if geographic payments adjustments must be app lied under the PFS, the current proxy occupations used for calculating the work GPCI should be re placed with actual physician salary survey data to determine the true cost (market price) of physician labor. To that end, the commenters suggested that third parties w ho hire physicians, for example hospitals, would be a good source for obtaining “market based” physician salary data . Additionally, one co mmenter encouraged us to work with the AMA and the Medical Group Ma nagement Association (MGMA) to evaluate the validity of the current proxy occupational data sources and to determine methods for gathering reliable physician cost data.199
Response : We appreciate the comments recei ved on the Institute of Medicine’s recommendations to revise the work GPCI methodology. We will continue to evaluate the comments received on the methodology used for determining the physician work GPCI in preparation for the seventh update to the GPCIs, which is scheduled to be implemented in CY 2014. We also look forward to the MedPAC study on this issue, which is required under section 3004 of the MCTRJCA. This st udy will assess whether any geographic adjustment to physician work is appropriate and, if so, what the leve l should be and where it should be applied. (D) Institute of Medicine Recommendation 5-6 : Office Rent Component of PE GPCI A new source of information should be developed to determine the variat ion in the price of commercial office rent per square foot. (Geographic Adjustment in Medicare Payment, Phase I: Improving Accuracy pages 5-38 thru 5-39) The Institute of Medicine recommends th e development of a new source of data to determine the variation in the price of commerci al office rent per square foot. However, the Institute of Medicine does not explicitly recommend where the data should come from or how it should be collected. Before coming to this reco mmendation, the Institute of Medicine identified and evaluated several public and commercially available sources of data to determine whether an accurate alternative is available to replace the re sidential rent data currently used as a proxy to measure regional variation in physicians’ cost to rent office space in the PE GPCI; these sources include rental data from the U.S. Department of Housing and Urban Development, American Housing Survey, General Services Administ ration, Basic Allowance for Housing (U.S. Department of Defense), U.S. Postal Service, MGMA (MGMA), and REIS, Inc. The Institute of Medicine concluded that these sources had substantial limitations, including lack of representativeness of the market in which physicia ns rent space, small sample size, low response rates, and sample biases. Although we agree that a suitable source for commercial office rent data would be preferable to the use of residential rent data in our PE office rent methodology, we200 have still been unable to identify an adequate commercial rent source that sufficiently covers rural and urban areas. We will continue to evaluate possible commerci al rent data sources for potential use in the office rent calculation. To th at end, we encouraged public commenters to notify us of any publicly available commercial rent data sources, w ith adequate data representation of urban and rural areas that could potentially be used in the calculation of th e office rent component of PE. However, we did not receive comments on spec ific data sources for commercial rent for purposes of determining the office rent component of the PE GPCI.
Comment : We received several comments that we re not within the scope of the CY 2013 proposed rule. For example, a few commenters expressed concerns about the methodology used for determining the CY 2012 GPCI values a nd the impact of the current PFS locality configuration on specific PFS localities. Response : We appreciate the comments regard ing the methodology used for determining the CY 2012 GPCI values and the impact they have on specific PFS localities. As discussed above, we did not make any proposed changes to the GPCI calculation methodology or values for CY 2013. Therefore, it would not be appropria te to consider making new adjustments to the GPCI values for a specific locality without provid ing the public an opportunity to comment. We will consider the commenters’ suggestions as we implement the seventh GPCI update anticipated in CY 2014. Result of Evaluation of Comments We appreciate the comments received on the Institute of Medicine’s recommendations regarding the PFS locality structure and the da ta sources and methodology used to calculate GPCI values. We will consider the commenters’ suggestions as we continue to evaluate options for reconfiguring the PFS locality structure and as we implem ent the seventh update to the GPCIs scheduled for CY 2014. We also look forward to conducting a full review and201

assessment of the Institute of Medicine’s a dditional PFS locality recommendations (as discussed in their Phase II report), as well as the MedPAC study on the physician work GPCI under the PFS that is required by section 3004 of the MCTRJCA. E. Medicare Telehealth Servi ces for the Physician Fee Schedule 1. Billing and Payment for Telehealth Services a. History Prior to January 1, 1999, Me dicare coverage for services delivered via a telecommunications system was limit ed to services that did not re quire a face-to-face encounter under the traditional model of medical care. Exam ples of these services included interpretation of an x-ray, or electrocardiogram, or electr oencephalogram tracing, and cardiac pacemaker analysis. Section 4206 of the BBA provided for cove rage of, and payment for, consultation services delivered via a telecommunications system to Medicare beneficiaries residing in rural health professional shortage areas (HPSAs) as defined by the Public Health Service Act. Additionally, the BBA required that a Medicare practitioner (teleprese nter) be with the patient at the time of a teleconsultation. Further, the BBA specified that payment for a teleconsultation had to be shared between the consulting practi tioner and the referring practitioner and could not exceed the fee schedule payment which would have been made to the consultant for the service furnished. The BBA prohibited payment for an y telephone line charges or facility fees associated with the teleconsu ltation. We implemented this provision in the CY 1999 PFS final rule with comment period (63 FR 58814). Effective October 1, 2001, sect ion 223 of the Medicare, Medicaid and SCHIP Benefits Improvement Protection Act of 2000 (Pub. L. 106-554) (BIPA) added a new section, 1834(m), to the Act which significantly expanded Medicare telehealth services. Section 1834(m)(4)(F)(i) of the Act defines Medicare telehealth services to include consu ltations, office visits, office202 psychiatry services, and any addi tional service specified by the Secretary, when delivered via a telecommunications system. We first implemente d this provision in the CY 2002 PFS final rule with comment period (66 FR 55246). Section 1834(m)(4)(F)(ii) of th e Act required the Secretary to establish a process that provides for annual updates to the list of Medi care telehealth services. We established th is process in the CY 2003 PFS fi nal rule with comment period (67 FR 79988). As specified in regulations at §410.78(b), we ge nerally require that a telehealth service be furnished via an interactive telecommunications system. Under §410.78(a)(3), an interactive telecommunications system is defined as multimed ia communications equipment that includes, at a minimum, audio and video equipment permitting two-way, real time interactive communication between the patient and the practitioner at the dist ant site. Telephones, facsimile machines, and electronic mail systems do not meet the definition of an interactive telecommunications system. An interactive tel ecommunications system is generally required as a condition of payment; however, section 1834 (m)(1) of the Act does allow the use of asynchronous “store-and-forward” technology in delivering these se rvices when the originating site is a federal telemedicine demonstration pr ogram in Alaska or Hawaii. As specified in regulations at §410.78(a)(1), stor e and forward means the asynchr onous transmission of medical information from an originating site to be re viewed at a later time by the practitioner at the distant site. Medicare telehealth services may be furnis hed to an eligible telehealth individual notwithstanding the fact that the individual practitioner furnishing the telehealth service is not at the same location as the beneficiary. An elig ible telehealth individual means an individual enrolled under Part B who receives a telehealth service furnished at an originating site. Under the BIPA, originating sites were limited under section 1834(m)(3)(C) of the Act to specified medical facilities located in specif ic geographic areas. The initial list of telehealth originating203 sites included the office of a practitioner, a crit ical access hospital (CAH), a rural health clinic (RHC), a federally qualified hea lth center (FQHC) and a hospital (as defined in Section 1861(e) of the Act). More recently, section 149 of the Medicare Improvements for Patients and Providers Act of 2008 (Pub. L. 110-275) (MIPPA) e xpanded the list of telehealth originating sites to include hospital-based renal dialysis centers, skilled nursing facilities (SNFs), and community mental health centers (CMHCs). In or der to serve as a telehealth originating site, these sites must be located in an area designate d as a rural health professional shortage area (HPSA), in a county that is not in a metropolitan stat istical area (MSA), or must be an entity that participates in a federal telemedicine demons tration project that ha s been approved by (or receives funding from) the Secretary of Health and Human Services as of December 31, 2000. Finally, section 1834(m) of the Act does not requir e the eligible telehea lth individual to be presented by a practitioner at the originating site. b. Current Telehealth Bi lling and Payment Policies As noted previously, Medicare telehealth servic es can only be furnished to an eligible telehealth beneficiary in an origin ating site. An originating site is defined as one of the specified sites where an eligible telehealth individual is locat ed at the time the service is being furnished via a telecommunications system. In general, originating sites must be located in a rura l HPSA or in a county outside of an MS A. The originating sites authoriz ed by the statute are as follows:

● Offices of a phys ician or practitioner;

● Hospitals;

● CAHs;

● RHCs;

● FQHCs;

● Hospital-Based or Critical Access Hospital-Based Renal Dialysis Centers (including Satellites);204

● SNFs;

● CMHCs. Currently approved Medicare telehealth services include the following:

● Initial inpatient consultations;

● Follow-up inpatient consultations;

● Office or other outpatient visits;

● Individual psychotherapy;

● Pharmacologic management;

● Psychiatric diagnostic interview examination;

● End-stage renal disease (ESRD) related services;

● Individual and group medi cal nutrition therapy (MNT);

● Neurobehavioral status exam;

● Individual and group hea lth and behavior assessmen t and intervention (HBAI);

● Subsequent hospital care;

● Subsequent nursing facility care;

● Individual and group kidney di sease education (KDE);

● Individual and group diabetes self -management training (DSMT); and

• Smoking cessation services.
In general, the practitioner at the distant si te may be any of the following, provided that the practitioner is licensed unde r state law to furnish the se rvice via a telecommunications system:

● Physician;

● Physician assistant (PA);

● Nurse practitioner (NP);205

● Clinical nurse specialist (CNS);

● Nurse-midwife;

● Clinical psychologist;

● Clinical social worker;

● Registered dietitian or nutrition professional. Practitioners furnishing Medicare telehealth serv ices submit claims for telehealth services to the Medicare contractors that process claims for the service area where their distant site is located. Section 1834(m)(2)(A) of the Act requires that a practitioner who furnishes a telehealth service to an eligible telehealth individual be paid an amount equal to the amount that the practitioner would have been pa id if the service had been furnished without the use of a telecommunications system. Distant site prac titioners must submit the appropriate HCPCS procedure code for a covered pr ofessional telehealth service, appended with the –GT (Via interactive audio and video telecommunica tions system) or –GQ (Via asynchronous telecommunications system) modifier. By repor ting the –GT or –GQ modi fier with a covered telehealth procedure code, the distant site practiti oner certifies that the be neficiary was present at a telehealth originating site when the teleheal th service was furnished. The usual Medicare deductible and coinsurance policie s apply to the telehealth serv ices reported by distant site practitioners. Section 1834(m)(2)(B) of the Act provides for pa yment of a facility fee to the originating site. To be paid the originati ng site facility fee, the provide r or supplier where the eligible telehealth individual is located must submit a claim w ith HCPCS code Q3014 (Telehealth originating site facility fee), and the provider or supplier is pa id according to the applicable payment methodology for that facility or lo cation. The usual Me dicare deductible and coinsurance policies apply to HCPCS code Q3014. By submitting HCPCS code Q3014, the originating site certifie s that it is located in either a ru ral HPSA or non-MSA county or is an206 entity that participates in a federal telemedicine demonstration project th at has been approved by (or receives funding from) the Secr etary of Health and Human Se rvices as of December 31, 2000 as specified in section 1834( m)(4)(C)(i)(III) of the Act. As previously described, certain professi onal services that ar e commonly furnished remotely using telecommunications technology, but that do not requ ire the patient to be present in-person with the practitioner when they are furn ished, are covered and paid in the same way as services delivered without the use of telecommunications tec hnology when the practitioner is in-person at the medical facility furnishing care to the patient. Such services typically involve circumstances where a practitioner is able to vi sualize some aspect of the patient’s condition without the patient being presen t and without the inte rposition of a third person’s judgment. Visualization by the practitione r can be possible by means of x-rays, electrocardiogram or electroencephalogram tracings, tissue samples, etc. For example, the interpretation by a physician of an actual electro cardiogram or electroencephalogram tracing that has been transmitted via telephone (that is, elec tronically, rather than by means of a verbal description) is a covered physician’s service. These remote serv ices are not Medicare te lehealth services as defined under section 1834(m) of the Act. Rather, these remote services that utilize telecommunications technology are c onsidered physicians’ services in the same way as services that are furnished in-person w ithout the use of telecommunicati ons technology; they are paid under the same conditions as in-person physicians’ services (with no requirements regarding permissible originating sites), a nd should be reported in the same way (that is, without the –GT or –GQ modifier appended). . 2. Requests for Adding Services to the Li st of Medicare Telehealth Services As noted previously, in the December 31, 2002 Federal Register (67 FR 79988), we established a process for adding services to or deleting services from the list of Medicare telehealth services. This process provides the public with an ongoing opportunity to submit207 requests for adding services. We assign any request to make additions to the list of telehealth services to one of two categor ies. In the November 28, 2011 Federal Register (76 FR 73102), we finalized revisions to criteria that we use to review requests in the second category. The two categories are:

● Category 1 : Services that are similar to profes sional consultations, office visits, and office psychiatry services that ar e currently on the list of telehealth services. In reviewing these requests, we look for similarities between the requested and existi ng telehealth services for the roles of, and interactions among, the beneficiar y, the physician (or other practitioner) at the distant site and, if necessary, the telepresente r. We also look for similarities in the telecommunications system used to deliver th e proposed service, for example, the use of interactive audio and video equipment.

● Category 2 : Services that are not similar to the cu rrent list of telehealth services. Our review of these requests include s an assessment of whether the service is accurately described by the corresponding code when delivered vi a telehealth and whether the use of a telecommunications system to deliver the service produces demonstrated c linical benefit to the patient. In reviewing these requests, we l ook for evidence indicating that the use of a telecommunications system in delivering the can didate telehealth service produces clinical benefit to the patient. Submitte d evidence should include both a de scription of relevant clinical studies that demonstrate the serv ice furnished by telehealth to a Medicare beneficiary improves the diagnosis or treatment of an illness or injury or improves the functioning of a malformed body part, including dates and findings, and a list and copies of pub lished peer reviewed articles relevant to the service when furnished via telehea lth. Our evidentiary standa rd of clinical benefit does not include minor or incidental benefits. Some examples of clinical be nefit include the following:208

● Ability to diagnose a medical condition in a patient population without access to clinically appropriate in person diagnostic services.

● Treatment option for a patient population without access to clinically appropriate inperson treatment options.

● Reduced rate of complications.

● Decreased rate of subsequent diagnostic or therapeutic interventions (for example, due to reduced rate of recurren ce of the disease process).

● Decreased number of future hos pitalizations or physician visits.

● More rapid beneficial resolution of the disease process treatment.

● Decreased pain, bleeding, or other quantifiable symptom.

● Reduced recovery time. Since establishing the process to add or re move services from the list of approved telehealth services, we have added the following to the list of Medicare telehealth services: individual and group HBAI services; psychiat ric diagnostic intervie w examination; ESRD services with 2 to 3 visits per month and 4 or more visits per month (a lthough we require at least 1 visit a month to be furnished in-person by a phys ician, CNS, NP, or PA in order to examine the vascular access site); individual and group MN T; neurobehavioral status exam; initial and follow-up inpatient telehealth consultations for beneficiaries in hospita ls and skilled nursing facilities (SNFs); subsequent hospital care (with the limitation of one telehealth visit every 3 days); subsequent nursing facility care (wit h the limitation of one telehealth visit every 30 days); individual and group KDE; and individual and group DSMT (with a minimum of 1 hour of in-person instruction to ensure e ffective injection traini ng), and smoking cessation services. Requests to add services to the list of Medicare telehealth services must be submitted and received no later than December 31 of each cale ndar year to be considered for the next209 rulemaking cycle. For example, requests s ubmitted before the end of CY 2012 will be considered for the CY 2014 proposed rule. Each request for adding a service to the list of Medicare telehealth services must include any supporting documentation th e requester wishes us to consider as we review the request. Because we use the a nnual PFS rulemaking process as a vehicle for making changes to the list of Medi care telehealth services, requestors should be advised that any information submitted is subject to public disclosure for this purpose. For more information on submitting a request for an addition to the list of Medicare telehealth services, including where to mail these requests, we refer readers to the CMS website at www.cms.gov/telehealth/

. 3. Submitted Request and Other Additions to th e List of Telehealth Services for CY 2013 We received a request in CY 2011 to add al cohol and/or substance abuse and brief intervention services as Medica re telehealth services effective for CY 2013. The following presents a discussion of this request, and our pr oposals for additions to the CY 2013 telehealth list. a. Alcohol and/or Substance Abuse and Brief Intervention Services The American Telemedicine Association s ubmitted a request to add alcohol and/or substance abuse and brief inte rvention services, reported by CP T codes 99408 (Alcohol and/or substance (other than tobacco) abuse structured screening (for example, AUDIT, DAST), and brief intervention (SBI) services; 15 to 30 minut es) and 99409 (Alcohol and/ or substance (other than tobacco) abuse structured screening (for example, AUDIT, DAST), and brief intervention (SBI) services; greater than 30 mi nutes) to the list of approved telehealth services for CY 2013 on a category 1 basis. We note that we assigned a status indicat or of ‘‘N’’ (Noncovered) to CPT codes 99408 and 99409 as explained in the CY 2008 PFS final ru le with comment period (72 FR 66371). At the time, we stated that because Medicare only provides payment for certain screening services210 with an explicit benefit category, and these CPT codes incorporate screen ing services along with intervention services, we believe d that these codes were inelig ible for payment under the PFS. We continue to believe that these codes are ineligible for payment under PFS and, additionally, under the telehealth benefit. We do not believe it would be appropriate to make payment for claims using these CPT codes for the services furn ished via telehealth, but not when furnished in person. Because CPT codes 99408 and 99409 are currently assigned a noncovered status indicator, and because we continue to believe this assignment is appropriate, we did not propose adding these CPT codes to the list of Me dicare Telehealth Services for CY 2013. However, we created two parallel G-codes for 2008 that allow for appropriate Medicare reporting and payment for alcohol and substance a buse assessment and intervention services that are not furnished as screening serv ices, but that are furnished in the context of the diagnosis or treatment of illness or injury. The codes ar e HCPCS code G0396 (Alcohol and/or substance (other than tobacco) abuse st ructured assessment (for exam ple, AUDIT, DAST) and brief intervention, 15 to 30 minutes) and HCPCS code G0397, (Alcohol and/or substance (other than tobacco) abuse structured asse ssment (for example, AUDIT, DAST) and intervention greater than 30 minutes). Since these codes are used to report comparable alcohol and substance abuse services under certain conditions, we believed that it would be appr opriate to consider the ATA’s request as it applies to these services when appropriately reported by the G-codes. The ATA asked that CMS consider this request as a cate gory 1 addition based on th e similarities between these services and CPT codes 99406 (Smoking and tobacco use cessation counseling visit; intermediate, greater than 3 minutes up to 10 minutes) and 99407 (Smoking and tobacco use cessation counseling visit; intensiv e, greater than 10 minutes). We agree that the interaction between a practitioner and a beneficiary receivi ng alcohol and substance abuse assessment and intervention services is similar to their inte raction in smoking cessation services. We also believe that the interaction between a practit ioner and a beneficiary receiving alcohol and211

substance abuse assessment and intervention services is similar to the assessment and intervention elements of CPT code 96152 (health and behavior intervention, each 15 minutes, face-to-face; individual), which also is currently on the telehealth list. Therefore, we proposed to add HCPCS codes G0396 and G0397 to the li st of telehealth services for CY 2013 on a category 1 basis. Consistent with this proposal, we also proposed to revise our regulations at §410.78( b) and §414.65(a)(1) to include alcohol and substance abuse assessment and intervention services as Medicare telehealth services. b. Preventive Services Under our existing policy, we add services to the telehealth list on a category 1 basis when we determine that they are similar to servic es on the existing telehealth list with respect to the roles of, and interactions among, the beneficiary, physician (o r other practitioner) at the distant site and, if necessary, th e telepresenter. As we stat ed in the CY 2012 proposed rule (76 FR 42826) , we believe that th e category 1 criteria not only st reamline our review process for publically requested services that fall into this category, the criteria also expedite our ability to identify codes for the telehealth list that rese mble those services already on this list. During CY 2012, CMS added coverage for se veral preventive services through the national coverage determination (NCD) process as authorized by section 1861(ddd) of the Act. These services add to Medicare’s existing portfolio of preventive services that are now available without cost sharing under the Affordable Care Act. We believe that for several of these services, the interactions between the furnishing practitioner and the beneficiary are similar to services currently on the list of Medicare telehea lth services. Specifically, we believe that the assessment, education, and counseling elements of the following services are similar to existing telehealth services:212

● Screening and behavioral counseling inte rventions in primary care to reduce alcohol misuse, reported by HCPCS codes G0442 (Annual alcohol misuse screening, 15 minutes) and G0443 (Brief face-to-face beha vioral counseling for alcohol misuse, 15 minutes).

● Screening for depression in adul ts, reported by HCPCS code G0444 (Annual Depression Screening, 15 minutes).

● Screening for sexually transmitted infecti ons (STIs) and high-intensity behavioral counseling (HIBC) to prevent STIs, reported by HCPCS code G0445 (High- intensity behavioral counseling to prevent sexually transmitted inf ections, face-to-face, individual, includes: education, skills training, and guidance on how to change sexual behavior, performed semiannually, 30 minutes).

● Intensive behavioral therapy for cardi ovascular disease, reported by HCPCS code G0446 (Annual, face-to-face intensive behavioral therapy for cardiov ascular disease, individual, 15 minutes).

● Intensive behavioral therapy for ob esity, reported by HCPC S code G0447 (Face-toface behavioral counseling for obesity, 15 minutes). We believe that the interactions between pr actitioners and beneficiaries receiving these services are similar to indi vidual KDE services reported by HCPCS code G0420 (Face-to-face educational services related to the care of chronic kidney diseas e; individual, per session, per one hour), individual MNT reported by HCPCS code G0270 (Medical nutrition therapy; reassessment and subsequent intervention(s) foll owing second referral in the same year for change in diagnosis, medical condition or treatm ent regimen (including additional hours needed for renal disease), individual, face-to-face with the patient, each 15 minutes); CPT code 97802 (Medical nutrition therapy; initial assessment a nd intervention, individual , face-to-face with the patient, each 15 minutes); and CPT code 97803 (M edical nutrition therapy; re-assessment and intervention, individual, face-to -face with the patient, each 15 minutes), and HBAI reported by213 CPT code 96150 (Health and behavior assessment (for example, health-focused clinical interview, behavioral observations, ps ychophysiological monito ring, health-oriented questionnaires), each 15 minutes face-to-face with the patient; initial assessment); CPT code 96151 (Health and behavior assessment (for exam ple, health-focused clinical interview, behavioral observations, psychophysiological mon itoring, health-oriented questionnaires), each 15 minutes face-to-face with the patient re-assessment); CPT c ode 96152 (Health and behavior intervention, each 15 minutes, face-to-face; Indi vidual); CPT code 96153 (Health and behavior intervention, each 15 minutes, face-to-face; Gr oup (2 or more patients)); CPT code 96154 (Health and behavior intervention, each 15 minu tes, face-to-face; fam ily (with the patient present)), all services that are currently on the telehealth list. Therefore, we proposed to add HC PCS codes G0442, G0443, G0444, G0445, G0446, and G0447 to the list of telehealth services for CY 2013 on a categor y 1 basis. We note that all coverage guidelines specific to the services w ould continue to apply when these services are furnished via telehealth. For example, when th e national coverage determination requires that the service be furnished to beneficiaries in a primary care setting, th e qualifying originating telehealth site must also qualify as a primary car e setting. Similarly, when the national coverage determination requires that the service be furnis hed by a primary care practitioner, the qualifying primary distant site practitioner must also qualify as primary care practitioner. For more detailed information on coverage requirements for these services, we refer readers to the Medicare National Coverage Determinations Manual, Pu b. 100-03, Chapter 1, Section 210, available at http://www.cms.gov/manuals/downloads/ncd103c1_Part4.pdf . Consistent with this proposal, we also proposed to revise our regulations at §410.78(b) and §414.65(a)(1 ) to include these preventive services as Medicare telehealth services.
Comment : All commenters expressed support for CMS’ proposals to add alcohol and/or substance abuse structured assessm ent and brief intervention servic es and the several preventive214

services established th rough the national coverage determination (NCD) pr ocess to the list of Medicare telehealth services for CY 2013. One commenter stated partic ular support for CMS’ approach to ensure that coverage guidelines continue to apply wh en these services are furnished via telehealth and expressed the intention to support CMS’ efforts to help educate practitioners about these preventive telehealth services ne wly available in 2013. A nother commenter stated that the proposal to add these services to this li st was an integral step forward for telehealth, but that the current breadth and level of services covered under the teleh ealth benefit is inadequate to support more robust telehealth capab ilities sought by some practitioners. Response : We appreciate the broad support for th e proposed additions to the list of Medicare telehealth services and the efforts of stakeholders to ensure that practitioners are educated about the addition of these services to the list of Medicare telehealth services. We believe that the delivery of services via telehea lth can help reduce barrie rs to health care access faced by some beneficiaries, and we remind all in terested stakeholders that we are currently soliciting public requests to add services to the list of Medicare telehe alth services. To be considered during PFS rulemaking for CY 2014, these requests must be submitted and received by December 31, 2012 or the close of the comment period for this final rule with comment period. Each request to add a serv ice to the list of Medi care telehealth services must include any supporting documentation the requester wishes us to consider as we review the request. For more information on submitting a request for an addition to the list of Medicare telehealth services, including where to mail these requests, we refer readers to the CMS website at www.cms.gov/telehealth/

. After consideration of the public comments received, we are finalizing our CY 2013 proposal to add HCPCS codes G 0396, G0397, G0442, G0443, G0444, G0445, G0446, and G0447 to the list of telehealth services for CY 2013 on a categor y 1 basis. We note that all coverage guidelines specific to the services wi ll continue to apply when these services are215 furnished via telehealth. For example, when th e national coverage determination requires that the service be furnished to beneficiaries in a pr imary care setting, the tele health originating site must also qualify as a primary care setting under the terms of the national coverage determination. Similarly, when the national cove rage determination require s that the service be furnished by a primary care practitioner, the distan t site practitioner who furnishes the telehealth service must also qualify as primary care practi tioner under the terms of the national coverage determination. For more detailed information on coverage requirements for these services, we refer readers to the Medicare National Covera ge Determinations Manual, Pub. 100-03, Chapter 1, Section 210, available at www.cms.gov/manuals/downloads/ncd103c1_Part4.pdf . Consistent with this proposal, we are also revising our regulations at §41 0.78(b) and §414.65(a)(1) to include alcohol and/or substan ce abuse structured assessment a nd intervention services and the preventive services as Medi care telehealth services. 4. Technical Correction to Include Emergenc y Department Telehealth Consultations in Regulation In the CY 2012 PFS final rule with comment period (76 FR 73103), we finalized our proposal to change the code desc riptors for initial inpatient tele health consultation G-codes to reflect telehealth consultations furnished to emergency department patients in addition to inpatient telehealth consultati ons effective January 1, 2012. However, we did not amend the description of the servic es within the regulation at §414.65(a)(1 )(i). Therefore, we proposed to make a technical revision to our regulation at §414.65(a)(1)(i) to reflect telehealth consultations furnished to emergency department patients in addition to hospital and SNF inpatients. We received no comments regarding our propos al to make this technical revision. Therefore, we are finalizing our proposal to make a technica l revision to our regulation at §414.65(a)(1)(i) to reflect telehealth consultations fu rnished to emergency department patients in addition to hospital and SNF inpatients.216 5. Telehealth Originating Site Fa cility Fee Payment Amount Update Section 1834(m)(2)(B) of the Act establishes the payment amount for the Medicare telehealth originating site facility fee for telehealth services provided from October 1, 2001, through December 31 2002, at $20. For telehealth services provided on or after January 1 of each subsequent calendar year, th e telehealth originating site facility fee is increased by the percentage increase in the MEI as defined in section 1842(i)(3) of the Act. The MEI increase for 2013 is 0.8 percent. Therefore, for CY 2013, the payment amount for HCPCS code Q3014 (Telehealth originating site facility fee) is 80 pe rcent of the lesser of th e actual charge or $24.43. The Medicare telehealth originating site facili ty fee and MEI increase by the applicable time period is shown in Table 18.

TABLE 18: The Medicare Telehealth Originat ing Site Facility Fee and MEI Increase by the Applicable Time Period Facility Fee MEI Increase Period $20.00 N/A 10/01/2001 – 12/31/2002 $20.60 3.0% 01/01/2003 – 12/31/2003 $21.20 2.9% 01/01/2004 – 12/31/2004 $21.86 3.1% 01/01/2005 – 12/31/2005 $22.47 2.8% 01/01/2006 – 12/31/2006 $22.94 2.1% 01/01/2007 – 12/31/2007 $23.35 1.8% 01/01/2008 – 12/31/2008 $23.72 1.6% 01/01/2009 – 12/31/2009 $24.00 1.2% 01/01/2010 – 12/31/2010 $24.10 0.4% 01/01/2011 – 12/31/2011 $24.24 0.6% 01/01/2012 – 12/31/2012 $24.43 0.8% 01/01/2013 – 12/31/2013
F. Extension of Payment for Technical Com ponent of Certain Physician Pathology Services 1. Background and Statutory Authority Section 542(c) of the Medi care, Medicaid, and SCHIP Benefits Improvement and Protection Act of 2000 (BIPA) (Pub. L. 106–554) pr ovided payment to independent laboratories furnishing the technical component (TC) of phys ician pathology servic es to fee-for-service Medicare beneficiaries who are in patients or outpatients of a cove red hospital for a 2-year period217 beginning on January 1, 2000. This section was s ubsequently amended by section 732 of the Medicare Prescription Drug, Improvement, a nd Modernization Act of 2003 (MMA) (Pub. L. 108–173), section 104 of division B of the Tax Relief and Health Care Act of 2006 (MIEA– TRHCA) (Pub. L. 109–432), section 104 of the Medi care, Medicaid, and SCHIP Extension Act of 2007 (MMSEA) (Pub. L. 110–173), section 136 of the Medicare Improvements for Patients and Providers Act of 2008 (MIPPA) (Pub. L. 110–275), section 3104 of the Affordable Care Act (Pub. L. 111–148), section 105 of the Medicare a nd Medicaid Extenders Act of 2010 (MMEA) (Pub. L. 111–309), section 305 of the Temporary Payroll Tax Cut Continuation Act of 2011 (Pub. L. 112-78) and section 3006 of the Middle Class Tax Relief and Job Creation Act of 2012 (Pub. L. 112-96) to continue payment to indepe ndent laboratories furnishing the technical component (TC) of physician pathology services to fee-for-service Medicare beneficiaries who are inpatients or outpatients of a covered hospital for various time periods. As discussed in detail below, Congress most recently acted to continue this payment through June 30, 2012. The TC of physician pathology services refers to the preparation of the slide involving tissue or cells that a pathologist interprets. The professional compon ent (PC) of physician pathology services refers to the pathologist’s inte rpretation of the slide. When the hospital pathologist furnishes the PC service for a hospital patient, the PC service is separately billable by the pathologist. Wh en an independent la boratory’s pathologist furnishes the PC service, the PC service is usually billed with the TC service as a combined or global service. Historically, any independent laboratory coul d bill the Medicare contractor under the PFS for the TC of physician pathology services for ho spital patients even t hough the payment for the costs of furnishing the pathology se rvice (but not its interpretati on) was already included in the bundled inpatient stay payment to the hospital. In the CY 2000 PFS final rule with comment period (64 FR 59408 and 59409), we stated that th is policy has contribut ed to the Medicare218 program paying twice for the TC service: (1) To the hospital, through the inpatient prospective payment rate, when the patient is an inpatient; and (2) To the independent laboratory that bills the Medicare contractor, instead of the hospital, for the TC service. While the policy also permits the independent laboratory to bill for the TC of physician pathology services for hospital outpatients, in this case, there generally w ould not be duplicate payment because we would expect the hospital to not also bill for the pathol ogy service, which would be paid separately to the hospital only if the hospital were to specifical ly bill for it. We further indicated that we would implement a policy to pay only the hospita l for the TC of physician pathology services furnished to its inpatients. Therefore, in the CY 2000 PFS final rule with comment period, we revised §415.130(c) to state that for physician pa thology services furnished on or after January 1, 2001 by an independent laboratory, payment is made onl y to the hospital for the TC of physician pathology services furnished to a hospital inpatient. Ordinaril y, the provisions in the PFS final rule with comment period are implemented in the following year. However, the change to §415.130 was delayed 1-year (until January 1, 2001), at the request of the industry, to allow independent laboratories and hospitals sufficient time to negotiate arrangements. Full implementation of §415.130 was further de layed by section 542 of the BIPA and section 732 of the MMA, which dire cted us to continue payment to independent laboratories for the TC of physician pathology services for hospi tal patients for a 2-year period beginning on January 1, 2001 and for CYs 2005 and 2006, respectively. In the CY 2007 PFS final rule with comment period (71 FR 69788), we amended §415.130 to provide that, for services furnished after December 31, 2006, an independent laborato ry may not bill the carrier for the TC of physician pathology services furnished to a hospita l inpatient or outpatient . However, section 104 of the MIEA–TRHCA continued payment to independent laboratori es for the TC of physician pathology services fo r hospital patients through CY 2007, and section 104 of the219 MMSEA further extended such payment through the first 6 months of CY 2008. Section 136 of the MIPPA extended the pa yment through CY 2009. Section 3104 of the Affordable Care Act amended the prior legi slation to extend the payment through CY 2010. Section 105 of the MMEA extended the paym ent through CY 2011. Subsequent to the publication of the CY 2012 PFS fi nal rule with comment period, section 305 of the Temporary Payroll Tax Cut Continuation Act of 2011 extend ed the payment through February 29, 2012 and section 3006 of the Middle Class Tax Relief a nd Job Creation Act of 2012 extended the payment through June 30, 2012. t15>2010 16:57 Nov 25, 2011 700 E:\FR\FM\28NOR2.SGM 28NOR2 2. Revisions to Payment for TC of Certain Physician Pathology Services In the CY 2012 PFS final rule with comment period, we finalized our policy that an independent laboratory may not bill the Medicare contractor for the TC of physician pathology services furnished after December 31, 2011, to a hospital inpatient or outpatient (76 FR 73278 through 73279, 73473). As discussed above, subsequent to publication of th at final rule with comment period, Congress acted to continue paym ent to independent laboratories through June 30, 2012. Therefore, the policy th at we finalized in the CY 2012 PFS final rule with comment period was superseded by statute for 6 months. To be consistent with th e statutory changes and our current policy, we proposed conforming cha nges to §415.130(d) such that we continued payment under the PFS to indepe ndent laboratories furnishing the TC of physician pathology services to fee-for-service Medi care beneficiaries who are inpatie nts or outpatients of a covered hospital on or before June 30, 2012 (77 FR 44763). Independent laboratories may not bill the Medicare contractor for the TC of physician pa thology services furnishe d after June 30, 2012, to a hospital inpatient or outpatient. We receiv ed no public comments on the proposed conforming changes so we are finalizing the revi sions to §415.130(d) without modification. G. Therapy Services 1. Outpatient Therapy Caps for CY 2013220 Section 1833(g) of the Act applies annual, per beneficiary, limitations (therapy caps) on expenses considered incurred for outpatient thera py services under Medicare Part B. There is one therapy cap for outpatient occupational thera py (OT) services and another separate therapy cap for physical therapy (PT) and speech-la nguage pathology (SLP) services combined. Although therapy services furnished in an outpatient hospital setti ng have been exempt from the application of the therapy cap s, section 3005(b) of the MCTR JCA amended section 1833(g) of the Act to include therapy services furnished in an outpatient hospital setti ng in the therapy caps. This provision is in effect from October 1, 2012 through December 31, 2012. The therapy cap amounts are updated each year based on the Medicare Economic Index (MEI). The annual change in the therapy cap amount for CY 2013 is computed by multiplying the cap amount for CY 2012 by the MEI for CY 2013 and rounding to the nearest $10. This amount is added to the CY 2012 cap, which is $1,880, to obtain the CY 2013 cap amount. The MEI for CY 2013 is 0.8 percent, resulting in a therapy cap amount for CY 2013 of $1,900. An exceptions process to the therapy caps ha s been in effect since January 1, 2006. Since originally authorized by sect ion 5107 of the Deficit Reduction Act (DRA), which amended section 1833(g)(5) of the Act, the exceptions process for the therapy caps has been extended through subsequent legislati on (MIEA-TRHCA, MMSEA, MIPPA, the Affordable Care Act, MMEA, and TPTCCA). Last amended by s ection 3005 of the MCTRJCA, the Agency’s authority to provide for an exception process to therapy caps expires on December 31, 2012. To request an exception to the therapy caps, thera py suppliers and providers use the KX modifier on claims for services after the beneficiary’s servic es for the year have exceeded the therapy cap. Use of the KX modifier indicates that the services are reasonable and necessa ry and that there is documentation of medical necessity in the beneficiary’s medical record. Section 3005 of the MCTRJCA also required two additional changes to Medicare policies for outpatient therapy services. Effective for serv ices furnished from October 1 through December221 31, 2012, after a beneficiary’s incurred expenses for PT and SLP services combined exceed the threshold of $3,700 during the calendar year, se ction 1833(g)(5)(C) of the Act, as amended by 3005(a)(5) of the MCTRJCA, requires that we apply a manual medical review process as part of the therapy caps exceptions pr ocess. Similar to the thera py caps, there is a separate $3,700 threshold for OT services. All requests for excep tions to the therapy caps for services after the $3,700 threshold is reached are subject to manual medical review. The manual medical review process is being phased in over a 3-month peri od. Unlike the therapy cap s, exceptions are not automatically granted for therapy services a bove the $3,700 threshold ba sed upon the therapist’s determination that they services are reasonable and necessary. To request an exception to the therapy caps for services after the threshold is reached, the provider sends a request for an exception to the Medicare contractor. The cont ractor then uses the coverage and payment requirements contained within Pub. 100-02, Medi care Benefit Policy Manual, section 220 and applicable medical review guidelin es, and any relevant local coverage determinations to make decisions as to whether an excep tion is approved for the services. For more information on the manual medical review process, go to www.cms.gov/Research-Statistics-Data-andSystems/Monitoring-Programs/Medical-Review/TherapyCap.html 2. Claims-Based Data Collection Strategy for Therapy Services a. Introduction Section 3005(g) of the MCTRJCA requires CM S to implement, beginning on January 1, 2013, “. . . a claims-based data co llection strategy that is design ed to assist in reforming the Medicare payment system for outpa tient therapy services subject to the limitations of section 1833(g) of the Act. Such strategy shall be desi gned to provide for th e collection of data on patient function during the course of therapy services in orde r to better understand patient condition and outcomes.” b. History/Background222
In 2011, more than 8 million Medicare benefi ciaries received outpati ent therapy services, including physical therapy (PT), occupationa l therapy (OT), and speech-language-pathology (SLP). Medicare payments for these se rvices exceeded $5.8 billion. Between 1998–2008, Medicare expenditures for outpatient therapy services increased at a rate of 10.1 percent per year while the number of Medicare beneficiaries re ceiving therapy services only increased by 2.9 percent per year. Although a si gnificant number of Medicare benefi ciaries benefit from therapy services, the rapid growth in Medicare expenditure s for these services has long been of concern to the Congress and the Agency. To address this concern, efforts have been focused on developing Medicare payment incen tives that encourage delivery of reasonable and necessary care while discouraging overutili zation of therapy services a nd the provision of medically unnecessary care. A brief review of these effort s is useful in understanding our policy for CY
2013. (1) Therapy Caps Section 4541 of the Balanced Budget Act of 1997 (Pub. L. 105-33) (BBA) amended section 1833(g) of the Act to im pose financial limitations on out patient therapy services (the “therapy caps” discussed above) in an attempt to limit Medicare expenditures for therapy services. Prior to the BBA amendment, thes e caps had applied to services furnished by therapists in private practice, but the BBA expanded the caps effective January 1, 1999, to include all outpatient therapy services except thos e furnished in hospital outpatient departments. Since that time, the Congress has amended the st atute several times to impose a moratorium on the application of the caps or has required us to implement an exceptions process for the caps. The therapy caps have only been in effect without a moratorium or an exceptions process for less than 2 years. (See the discussion about the ther apy cap exceptions process above.) Almost from the inception of the therapy caps, Congress a nd the Agency have been exploring potential alternatives to the therapy caps.223 (2) Multiple Procedure Payment Reduction (MPPR) In the CY 2011 PFS final rule with comme nt period (75 FR 73232-73242), we adopted a MPPR of 25 percent ap plicable to the practice expense (PE) com ponent of the second and subsequent therapy services furnished to a benefi ciary when more than one of these services is furnished in a single session. This reduction applie s to nearly 40 therapy se rvice codes. (For a list of therapy service codes to which this pol icy applies, see Addendum H.) The Physician Payment and Therapy Relief Act of 2010 (PPATRA) subsequently revised the reduction to 20 percent for the second and subsequent therapy se rvices furnished to a beneficiary in an office setting, leaving the 25 percent reduc tion in place for therapy services furnished to a beneficiary in institutional settings. We adopted this M PPR as part of our directive under section 1848(c)(2)(K) of the statute, as added by section 3134(a) of the Affordable Care Act, to identify and evaluate potentially misvalued codes. By ta king into consideration the expected efficiencies in direct PE resources that occur when services are furnished together, this policy results in more appropriate payment for therapy services
. Although we did not adopt this MPPR policy specifically as an altern ative to the therapy caps, paying more appropriately for combinations of therapy services that are commonly furnishe d in a single session reduces the number of beneficiaries impacted by the therapy caps in a given year. For more details on the MPPR policy, see section II.B.4. of this final rule with comment period. (3) Studies Performed The therapy cap is a uniform dollar amount that sets a limit on the total value of services furnished unrelated to the specifi c services furnished or the bene ficiary’s condition or needs. A uniform cap does not deter unnecessa ry care or encourage efficient practice for low complexity beneficiaries. In fact, it may even encourage the provision of serv ices up to the level of the cap. Conversely, a uniform cap without an exceptions pr ocess restricts necessary and appropriate care for certain high complexity beneficiaries. R ecognizing these limitations in a uniform dollar224 value cap, we have been studying therapy practice patterns and exploring ways to refine payment for these services as an alte rnative to therapy caps. On November 9, 2004, the Secretary delivered the Report to Congress, as required by the BBA as amended by the BBRA, “Medicare Fina ncial Limitations on Outpatient Therapy Services.” This report included two utilizati on analyses. Although these analyses provided details on utilization, neither specif ically identified ways to impr ove therapy payment. In the report, we indicated that further study was underway to assess alte rnatives to the therapy caps. The report and the analyses are available on the CMS website at www.cms.gov/TherapyServices/

. Since 2004, we have periodically updated th e utilization analyses and posted other reports on the CMS website. These reports highlighted the expected effects of limiting services in various ways and presented plans to colle ct data about benefici ary condition, including functional limitations, using availa ble tools. Through these efforts, we have made progress in identifying the types of outpatien t therapy services that are bille d to Medicare, the demographics of the beneficiaries who utilize these services, the HCPCS codes used to bill the services, the allowed and paid amounts of the services, the prov iders of these services, the therapy utilization patterns among states in which the services are furnished, and the type of practitioner furnishing services. From these and other analyses in our ongoing research effort, we have concluded that without the ability to define the services that are typically needed to address specific clinical cohorts of beneficiaries (those with similar risk-a djusted conditions), it is not possible to develop payment policies that encourage the delivery of reasonable and nece ssary services while discouraging the provision of services that do not produce a clinical benef it. Although there is widespread agreement that beneficiary conditio n and functional limitations are critical to developing and evaluating an alternative paymen t system for therapy services, a system for225 collecting such data unif ormly does not exist. Currently diagnosis information is available from Medicare claims. However, we believe that the diagnosis on the claim is a poor predictor for the type and duration of therapy services required. Additional work is needed to develop an appropriate system for classifying clinic al cohorts to determine therapy needs. A 5-year CMS project titled “Development of Outpatient Therapy Payment Alternatives” (DOTPA) is expected to provide some of this information. The purpose of the DOTPA project is to identify a set of measures that we could collect routinel y and reliably to support the development of payment alternat ives to the therapy caps. Specifically, the measures being collected are assessed for administrative feasibi lity and usefulness in identifying beneficiary need for outpatient therapy services and the out comes of those services. The data collection processes have just been completed and a final DOTPA report is expected in late CY 2013. In addition to developing alternatives to the therapy caps, the DOTPA project reflects our interest in value-based purchasing by identifying components of value, namely, the beneficiary need and the effectiveness of therapy se rvices. Although we expect DOTP A to provide meaningful data and practical information to assist in devel oping improved methods of paying for appropriate therapy services, it is unlikely th at this one project al one will provide adequate information to implement a new payment system for therapy. This study combined with data from a wider group of Medicare beneficiaries would enhance our ability to develop alte rnative payment policy for outpatient therapy services. (c) System Description and Requirements (1) Overview Section 3005(g) of MCTRJCA requires CM S to implement a claims-based data collection strategy on January 1, 2013 to gather information on beneficiary function and condition, therapy services furnished, and outcomes achieved. This information will be used in assisting us in reforming the Medicare payment system for outpatient therapy services. By226 collecting data on beneficiary function over an ep isode of therapy services, we hope to better understand the Medicare benefici ary population who uses therapy services, how th eir functional limitations change as a result of therapy serv ices, and the relationship between beneficiary functional limitations and furnished therapy. The long-term goal is to develop an impr oved payment system for Medicare therapy services. The desired payment system would pa y appropriately and simi larly for efficient and effective services furnished to beneficiaries with similar conditions and functional limitations that have potential to benefit fr om the services furnished. Impor tantly, such a system would not encourage the furnishing of medically unnecessary or excessive services. At this time, the data on Medicare beneficiaries’ use and outcomes from therapy services from which to develop an improved system does not exist. This data collecti on effort is the first step towards collecting the data needed for this type of payment reform. Once the initial data have been collected and analyzed, we expect to identify gaps in information and determine what additional data would be needed to develop a new payment policy. Without a better understandi ng of the diversity of beneficiaries receiving therapy services and th e variations in type and volume of treatments provided, we lack the information to develop a comprehensive strategy to map the way to an improved payment policy. While this claims-based da ta collection is only the first step in a longterm effort, it is an essential step. In the CY 2013 proposed rule, we proposed to implement section 3005(g) of MCTRJCA by requiring that claims for therapy services include nonpayable G-c odes and modifiers. Through the use of these codes and modifiers, we proposed to capture data on the beneficiary’s functional limitations (a) at th e outset of the therapy episode , (b) at specified points during treatment and (c) at discharge from the outpatien t therapy episode of care. In addition, the therapist’s projected goal for func tional status at the end of treat ment would be reported on the first claim for services and periodic ally throughout an episode of care.227 Specifically, as proposed, G-codes would be us ed to identify what type of functional limitation is being reported and wh ether the report is on the current status, pr ojected goal status or discharge status. Mo difiers would indicate the severity/complexity of the functional limitation being tracked. The difference between the reported functional status at the start of therapy and projected goal status represents any progress the therapist antici pates the beneficiary would make during the course of treatment/e pisode of care. We proposed that these reporting requirements would apply to all therapy claims, including thos e for services above th e therapy caps and those that include the KX modifi er (described above). By tracking any changes in functional limitati ons throughout the therapy episode of care and at discharge, we would have information about the therapy servic es furnished and the outcomes of such services. The ICD-9 diagnos is codes reported on the claim form would provide some information on the beneficiary’s condition. We proposed that these claims-based data collection requirements would apply to services furnished under the Medicare Part B ou tpatient therapy benefit and PT, OT, and SLP services under the Comprehensive Outpatient Rehabilitation Faciliti es (CORF) benefit. We also proposed to include therapy services furnished personally and “incident to” the services of physicians or nonphysician practitioners (NPPs). As we explained in the proposed rule, this broad applicability would include therapy services furnished in hos pitals, critical access hospitals (CAHs), skilled nursing facilities (SNFs), CORFs, rehabilitation agencies, home health agencies (when the beneficiary is not under a home health plan of care), and in private offices of therapists, physicians and NPPs. When used in this section “therapists” m eans all practitioners who furnish outpatient therapy services, including physic al therapists, occupational th erapists, and speech-language pathologists in private practice and those therap ists who furnish services in the institutional settings, physicians and NPPs (i ncluding, physician assistants (PAs ), nurse practitioners (NPs),228 clinical nurse specialists (CNSs), as applicab le.) The term “functional limitation” generally encompasses both the terms “activity limitations” a nd “participation restric tions” as described by the International Classification of Functioning, Disa bility and Health (ICF). (For information on ICF, see www.who.int/classifications/icf/en/ and for specific ICF nomenclature (including activity limitations and participation restrictions), see http://apps.who.int/class ifications/icfbrowser/. The CY 2013 proposal was based upon an optio n for claims-based data collection that was developed as part of the Short Term Alte rnatives for Therapy Services (STATS) project under a contract with CMS, which provided three op tions for alternatives to the therapy caps that could be considered in the short-term before completion of the DOTPA project. In developing options, the STATS project drew upon the analy tical expertise of CMS contractors and the clinical expertise of va rious outpatient therapy stakeholders to consider policies and available claims data. The options developed were:

● Capturing additional clini cal information regarding the severity and complexity of beneficiary functional impairments on therapy claims in order to facilitate medical review and at the same time gather data that would be useful in the long term to de velop a better payment mechanism;

● Introducing additional claims edits regarding medical necessity to reduce overutilization; and

● Adopting a per-session bundled payment, the amount of which would vary based on beneficiary characteristics and th e complexity of evaluation and treatment services furnished in a therapy session. Although we did not propose to adopt any of thes e alternatives at that time, we discussed and solicited public comments on all aspects of these options during the CY 2011 rulemaking. (See 75 FR 40096 through 40100 and 73284 through 73293.) In developing the CY 2013229 claims-based data collection proposal, we us ed the feedback received from the CY 2011 rulemaking. We noted in the proposal that the proposed claims-based data collection system using Gcodes and severity modifiers builds upon current Medicare requirements for therapy services. Section 410.61 requires that a ther apy plan of care (POC) be esta blished for every beneficiary receiving outpatient ther apy services. This POC must incl ude: the type, amount, frequency, and duration of services to be furnished to each bene ficiary, the diagnosis and the anticipated goals. Section 410.105(c) contains simila r requirements for services furn ished in the CORF setting. We have long encouraged therapists, thr ough our manual provisions, to express the POCrequired goals for each beneficiary in functiona l terms and require that goals be based on measureable assessments or objective data and rela te to identified functional impairments. See Pub 100-02, Chapter 15, Section 220.1.2. We also noted that the evaluation and the goals developed as part of the POC would be th e foundation for the init ial reporting under the proposed system. The following is a summary of the comments we received regarding the general approach proposed in the CY 2013 PFS proposed rule to require nonpayable G-codes and modifiers on therapy claims to implement th e new statutory requirement.
Comment : Most commenters supported a new paym ent system for therapy services and recognized that data would be a critical factor in the development of such a system. Others recognized that the statute required CMS to implem ent a claims-based data collection system and therefore addressed comments to the specific elem ents rather than the overall requirement. Many commenters expressed concer ns that the data we would be collecting under the proposed system would not provide adequate data for us to develop a new payment system. Many commenters also expressed concern that the system would not provide the means for therapists to adequately convey why some beneficiaries n eeded more treatment. Toward this end,230 commenters suggested that we include a way to risk adjust th e data or collect more beneficiary information. Some commenters suggested that we establish a dditional G-codes to report the beneficiary’s complexity, such as whether th eir condition is of low, moderate, or high complexity. These G-codes would represent the multiple variables that affect a beneficiary’s condition and response to therapy, such as ag e, comorbidities, prognosis, patient safety considerations, and current clinic al presentation. One associati on indicated that it is working on an alternative payment system that will define and use three levels of complexity. Many commenters pointed out that the data we proposed to collect c ould only provide information on the progress an individual be neficiary made and was not valid for analyzing payment alternatives. Response : We agree with commenters that the data collected under this system will not alone provide all the information that CMS needs to de velop, analyze and implement an alternative payment system. We agree with the commenters that factors such as the patient’s overall condition, including age, co morbidities, etc. are likely to affect the response to therapy; and we further agree that being able to anal yze the data collected on such variables would enhance the usefulness of our da ta. Although we agree with the commenters’ that it could be beneficial to include additional data elemen ts to reflect the patient’s condition and the complexity of the case, a meaningful system to use in classifying a beneficiary’s complexity does not currently exist. As experience is gained with this new system, we expect that through future notice and comment rulemaking we will be able to enhance the system.
Comment : Many commenters commented on the administrative burden that therapists would incur if the proposed system was implemen ted. Some commented that the administrative burden would be particularly significant for phys ical therapists in pr ivate practice who often submit claims after each therapy visit. Co mmenters labeled the proposal “improper,” “unreasonable,” and “overly burdensome.” Othe r commenters indicated that the proposed231 process would not be burdensome stating that the functional assessment tools they use were “perfectly suited to comply with CMS rule for data collection points, so we anticipate little or no burden in complying with the collection of functi on at intake, predicting discharge function at intake, during care and at discharge from care.” In addition to the many commenters who noted the additional work that would be required to co mply with this system, one commenter suggested that we also add a billable G-c ode to pay therapists for the additional work that this proposal would require. Response : While we recognize that complying with these new reporting requirements will impose an additional burden on therapists, we believe that having available additional data on the therapy services furnished and the bene ficiaries who receive them is critical to development of an alternative payment system for therapy services. Although we acknowledge that there would be work and some additiona l effort in complying with these reporting requirements, we believe that the additional bur den is minimal. We designed our proposal to mesh closely with information that therapists already include in the medical record. The proposal would merely require that the informa tion be translated into the new G-codes and modifiers, and included in additional lines on the same claims that would otherwise be submitted. We do not believe this reporting requirement would significantly increase the resources required to furnish therapy services.
Comment : A couple of commenters suggested th at we abandon our G-code/modifier proposal and use diagnosis codes in its place. One recognized that CMS’s assertion that diagnosis codes on the claims do not provide the data that we need was valid when only the principal diagnosis is used, but st ated that if we relied upon prin cipal and secondary diagnosis we could obtain the additional information regarding the patient’s clinical condition and functional limitations. The commenter provided the exam ple of when hemiparesis was coded as the secondary diagnosis. Some suggested that when the ICD-10 system is implemented the232 diagnosis codes would provi de better information. Response : We continue to believe that diagnosi s codes, even when secondary diagnoses are included, do not provide the in formation on functional limitations that the statute requires us to collect. In the example the commenter provid ed, use of the diagnosis code “hemiparesis,” would only tell us that the benefi ciary needs therapy due to a para lysis or weakness on one side of his or her body caused by a stroke or other brain trauma, but not the extent of the beneficiary’s functional limitation. With rega rd to use of ICD-10, the statut e requires us to implement a functional reporting system by January 1, 2013 so we cannot wait for ICD-10 system to implement the reporting requirements.
Comment : One commenter requested to be exem pted from these reporting requirements because the organization furnishes such a small amount of Part B outpatient therapy services. Another noted that “Given that this policy may affect HOPDs only for 3 months, CMS should consider ways to impose minimal administrativ e burden on HOPDs to implement this policy.” One commenter sought assurance that CAHs were included in this data collection effort. Response : As we indicated in the proposed rule, our goal is to have data on the complete range of therapy services for which payment is made based on the PFS for use in assessing and developing potential alternative pa yment systems for those services. This is important since any new payment system would likely apply to all thos e therapy services that are currently paid at rates under the PFS. To meet this goal, we pr oposed that the reporting requirements apply to all providers and suppliers of outpatient therapy serv ices and CORFs. We note that the proposed policy would apply to hospital outpatient departme nt services, even if such services are not subject to the therapy ca ps after December 31, 2012, and to serv ices furnished in CAHs. We are finalizing without change the proposed policy to apply the reporting requir ements to hospitals, SNFs, rehabilitation agencies, CORFs, home health agencies (when the be neficiary is not under a home health plan of care) and private offices.233

Comment : Several commenters raised concerns about a new payment system based upon the data collected without a standardized tool, sta ting that such data would not provide reliable information on which to develop an altern ative payment system. Additionally, some commenters believed the invalid data would be used to create a payment system based upon functional limitations. Response : At this time we are not making any changes in the existing payment methodology for therapy services, ex cept that therapists will have to comply with the reporting requirements to receive payment for furnished ther apy services. Therapists will continue to be paid in CY 2013 under the existing payment met hodology, which includes the therapy caps. We will closely monitor and implement any enacted legislation that would amend the current statutory provisions, including any amendment to extend the therapy cap exceptions process. At this time we are broadly consid ering options for a revised paymen t system for therapy services and do not have any preconceived ideas as to what such a system would like or what it would be based upon. The purpose of the da ta collection proposal describe d in the CY 2013 PFS proposed rule is to meet the statutory re quirement and begin to gather data that will be used, along with other data and information that we have, to develop and analyze poten tial alternative payment systems. It is likely that changes will be made in the data collected as we gain experience with this system. Therapists and others concerned w ith Medicare payment for therapy services should not draw conclusions about any future payment system for th erapy services based upon the claims-based data that we proposed to collect . The claims-based data is only one set of information that will be used and it is only a be ginning step in gathering the information that we would need to consider in developing a re vised payment system for therapy services.
Comment : Some commenters suggested that the “preamble language implies that improvement is a requirement for ongoing Medicare coverage.” One commenter suggested that the preamble language “implies that a measurab le improvement in a beneficiary’s functional234 limitation is required during an epis ode of therapy services.” Others expressed concern that some beneficiaries, such as those with spinal cord injuries, will be denied coverage because they improve too slowly. Response : We did not intend for the preamble la nguage to raise concern about changing coverage conditions for benefici aries who need therapy services. As noted above, the purpose of the claims-based data collection sy stem is simply to gather data, and we did not propose, nor are we implementing, any changes to coverage or paym ent policy for therapy se rvices other than to require that therapists comply with the repor ting requirements to receive payment for therapy services they furnish. Under ex isting IOM requirements, therapists have to establish a long-term goal for beneficiaries receiving ther apy. What is new under this syst em is that at the outset of treatment, the therapist will need to report on the claim the projected goal for treatment using modifiers that describe the percen tage of impairment. For benefi ciaries who are not expected to improve, such as those receiving maintenance th erapy, the same modifier would be used for current status and for projected goal status. It is possible for some beneficiaries that while improvement is expected, it is expected to be li mited, and thus it will also be reported using the same modifiers. To emphasize, the collection of these data elements will not affect a beneficiary’s coverage of therapy services.
Comment : Some commenters expressed concerns about how this proposal would affect individuals suffering from lymphe dema. Commenters stated that some clients experience both pain and swelling while others seem to have onl y swelling of a limb. Successful management of a beneficiary with lymphedema involves ba ndaging, compression and skin care instruction, manual lymph drainage, decongestive therapy, manua l lymph drainage instruction, and exercise. These services take lots of valuable practiti oner time to perform correctly as does instructing caregivers. While lymphedema impacts function to a point of mild to severe disability, many commenters told us that lymphede ma severity/complexity is very difficult to quantify and show235 significant functional improvement s in the lymphatic system when many of these improvements are in skin integrity, cellular health and lymphatic flow. Othe r commenters stated that the patient’s functional limitations due to lymphede ma (restricted motion and/or mobility) can range from profound to minimal. But all lymphedema patients, including those pr oficient in self-care who have minimal functional limitations, are at great risk for developing ce llulitis or other major medical complications from sustained tissue conge stion of the lymphatic system. With ongoing or periodic management, as appropriate, therapy services can successfully prevent these medical crises. Many commenters expressed c oncern that coverage for therapy services relating to lymphedema would be denied as a result of th is proposal. Others que stioned which functional limitation to use for lymphedema patients. Response : As noted earlier, we did not propose to change coverage policy or to use the claims-based data reporting system to determin e which beneficiaries are entitled to therapy services. Instead, our proposal would require those furnishing care to provide certain information about the beneficiary and his or her expected response to therapy. We are reiterating in this final rule with comment period that the proposed claims-based data collection system makes no changes in our therapy coverage policies. With regard to how those treating beneficiar ies should comply with the data collection system, we expect therapists to report the G-co de for the functional limitation that most closely relates to the functional limitation being treated. As a result of comments on the proposed rule, we are clarifying in this final rule with comme nt period that if the therapy services being furnished are not intended to tr eat a functional limitation, the ther apist should use the G-code for “other” and the modifier representing zero.
Comment : Several commenters suggested that significant education will be required for therapists to comply with this required reporting. Response : We are publishing in this final rule with comment period the claims-based236 reporting requirements that must be met in order to receive payment for therapy services. We will also use our usual methods for providing ad ditional information, including revising relevant sections of the IOM, publis hing Medicare Learning Networ k (MLN) Matters articles; presentations on Open Door Forums, and conducting National Provider Calls on the new requirements. We urge therapist to use these tool s to assure that they have the information they need to comply with these new requirements. (2) Nonpayable G-Codes on Be neficiary Functional Status We proposed that therapists would report G- codes and modifiers on Medicare claims for outpatient therapy services. We discussed and so ught comment on two types of G-codes in the proposed rule – generic and categorical. Ta ble 19 shows the proposed generic G-codes and Table 20 shows the categorical code s discussed in the proposed rule. TABLE 19: Proposed Nonpayable G-Codes for Reporting Functi onal Limitations. Functional limitation for primary functional limitation Primary Functional limitation, Current status at initial treatment/episode outset a nd at reporting intervals GXXX1 Primary Functional limitation, Projected goal status GXXX2 Primary Functional limitation, Status at therapy discharge or end of reporting GXXX3 Functional limitation for a secondary functional limitation if one exists Secondary Functional limitation, Current status at initial treatment/outset of therapy and at reporting intervals GXXX4

Secondary Functional limitation, Projected goal status GXXX5 Secondary Functional limitation, Status at therapy discha rge or end of reporting GXXX6 Provider attestation that f unctional reporting not required Provider confirms functional reporting not required GXXX7

The proposed G-codes differ from the three se parate pairs of G-codes discussed in the CY 2011 PFS rulemaking. The CY 2011 discussion incl uded these three pairs of G-codes, all of which reflect specific ICF terminology:

● Impairments of Body Functions and/ or Impairments of Body Structures;237

● Activity Limitations and Pa rticipation Restrictions; and

● Environmental Factors Barriers. Each pair contained a G-code to represent the beneficiary’s curre nt functional status and another G-code to represent the beneficiar y’s projected goal stat us. Each claim would have required all three sets of G-codes. Like the G-codes we pr oposed for CY 2013, the G-codes discussed in the CY 2011 PFS rulemaking would have been used with modifiers to reflect the severity/complexity of each element. In the CY 2013 PFS proposed rule, we indicated that we were not proposing to use these specific G-codes because we found them to be po tentially redundant and confusing. Instead we chose to use G-codes to define “functional lim itations” synonymously with the ICF terminology “activity limitations and part icipation restrictions.” We noted that requiring separate reporting on three elements would have imposed a grea ter burden on therapists without providing a meaningful benefit in the valu e of the data provided. We added that because environmental barriers as discussed in CY 2011 are contextual, we did not be lieve collecting information on them would contribute to developi ng an improved payment system. To create the select ca tegories of G-codes discussed in the proposed rule (See Table 20) we used the two most frequently reported functional limitations in the DOTPA project by each of the three therapy disciplines. We noted that s hould we decide to use a system with categoryspecific reporting, we would expe ct to develop specific nonpayable G-codes for select categories of functional limitations in the final rule. We ex plained that if one of the select categories of functional limitations describes the functional limitation being re ported, that G-code set would be used to report the current, projected goal, and discharge status of the beneficiary. When reporting a functional limitation not described by one of categorical G-codes, one of the generic G-codes previously desc ribed would be used. TABLE 20: Select Categories of G-Co des Discussed in Proposed Rule238
Walking & Moving Around Walking & moving around func tional limitation, current status at time of initial therapy treatment/episode out set and reporting intervals GXXX8 Walking & moving around func tional limitation, projected go al status, at initial therapy treatment/outset and at discharge from therapy GXXX9 Walking & moving around f unctional limitation, discharg e status, at discharge from therapy/end of reporting on limitation GXX10 Changing & Maintaining Body Position Changing & maintaining body position func tional limitation, current status at time of initial therapy treatment/epi sode outset and re porting intervals GXX11 Changing & maintaining body position f unctional limitation, projected goal status at initial therapy treatment/ outset and at discharge from therapy GXX12 Changing & maintaining body position func tional limitation, discharge status at discharge from therapy/e nd of reporting on limitation GXX13 Carrying, Moving & Handling Objects Carrying, moving & handling objects func tional limitation, current status at time of initial therapy treatment/epi sode outset and re porting intervals GXX14 Carrying, moving & handling objects f unctional limitation, projected goal status at initial therapy treatment/ outset and at discharge from therapy GXX15 Carrying, moving & handling objects functi onal limitation, discharge status at discharge from therapy/end of reporting on limitation GXX16 Self Care (washing oneself, toil eting, dressing, eating, drinking) Self care functional limitation, current status at time of initial therapy treatment/episode outset and reporting intervals GXX17 Self care functional limitation, projec ted goal status at initial therapy treatment/outset and at discharge from therapy GXX18 Self care functional limitation, discharge status at discharge from therapy/end of reporting on limitation GXX19 Communication: Reception (spoken, nonverbal, sign language, written) Communication: Reception functional lim itation, current status at time of initial therapy treatment/episode outset and reporting intervals GXX20 Communication: Reception functional limitati on, projected goal status at initial therapy treatment/outset and at discharge from therapy GXX21 Communication: Reception functional limita tion, discharge status at discharge from therapy/end of reporting on limitation GXX22 Communication: Expression (speaking, nonverbal, sign lang uage, writing) Communication: Expression functional li mitation, current status at time of initial therapy treatment/episode outset and reporting intervals GXX23 Communication: Expression functional li mitation, projected goal status at initial therapy treatment/outset and at discharge from therapy GXX24 Communication: Expression functional limitation, discharge status at discharge from therapy/end of reporting on limitation GXX25

We sought input from therapists on categorie s of functional limita tions, such as those described in this section. We specifically requested comments re garding the following questions:239 Would data collected on categorie s of functional limitations provide more meaningful data on therapy services than that collected through use of the generic G-codes in our proposal? Should we choose to implement a system that is based on at least some select categories of functional limitation, which functional limitations should we coll ect data on in 2013? Is it more, less or the same burden to report on categories of functional limitations or generic ones? The categories of functional limitations described above are based on the ICF categor ies, but these ICF categories also have subcategories. Should we use sub categories for reporting? Are there specific conditions not covered by these IC F categories? Would we need to have G-codes for the same categories of secondary limitations? We sought public comment on whether these proposed Gcodes allow adequate reporting on beneficiary’s functional limitati ons. We also noted that we would particularly appreciate receiving sp ecific suggestions for any missing elements. The following is a summary of the comments we received on the G-codes, generic and categorical, whether these pr oposed G-codes allow adequate reporting on beneficiary’s functional limitations, and specific s uggestions for any missing elements.
Comment : Two commenters disagreed with our proposal to devel op new G-codes and instead encouraged us to use the three pairs of G-codes (activities and participation restrictions, impairments to body functions/structures and envir onmental barriers) from the STATs project to report functional limitations. These commenters agreed that adding th ese domains might be more burdensome, but one commenter suggested that without these data elements we would likely miss integral beneficiary data in relation to health and wellness bene fits, such as increased muscle function, improved quality of life, d ecreased depression, im proved bowel/bladder function, improved respiratory f unction, improved autonomic function and improved circulation. Another commenter specifically agreed with our decision to use only the one ICF-defined Gcode from the STATS for activity impairments and participation rest rictions. They noted that it would be potentially redundant and confusi ng to adopt the two additional G-codes for body240

functions/structures and environm ental barriers and noted that these other two categories would “provide the agency with little meaningful data.” One commente r suggested that if we adopted this additional reporting we could minimize th e additional burden by el iminating goal reporting. Response : We appreciate the views of these co mmenters about which ICF categories to capture in our G-code data collection. We cont inue to believe that the reporting of functional limitations will be less confusing and more defi ned with the G-codes as described in our proposal for activity impairments/pa rticipation restricti ons. As we move forward with functional reporting in following years, we may revis it the addition of ot her categories.
Comment : Commenters had divergent views on th e categorical and generic G-codes. Many found the proposed system complicated, burden some and stated that it would not provide the data we sought. Some criticized the catego rical codes as being t oo broadly defined and stated that this will lead to confusion as to wh at areas of impairment are being reported. For example, one commenter stated, “The suggested categories are very broad and, in our view, will lead to confusion regarding wh ich areas of impairment would be reported for certain therapy activities.” One commenter opposed the use of generic G-codes saying that data from these codes would be “useless.” On the other hand, we received much support for the proposed Gcodes. Many commenters supported the use of ca tegorical G-codes codes saying their use will provide more useful information than the gene ric ones. One commenter stated, “We believe having therapists report on these categories will pr ovide CMS with more useful information than generic reporting on a functional limitation.” Many favored use of the categorical G-codes in addition to using “generic” or “other” codes only fo r functional limitations that did not fit in one of the categorical ones. Several commenters gave us specific guidance, recommending that instead of the generic G-codes, we add an “other ” G-code to the categori cal codes for functional limitations that don’t fit into one of the defined categories. Response : Based upon the comments we received suggesting that we use the categorical241
codes, but include an “other” ca tegory to use when one of the categorical codes does not apply, we are modifying our proposal to adopt categorical G-codes to de fine functional limitations and including within the categorical G-codes “other” G-codes to use when one of the more specific categorical codes does not apply. In addition to this change, as discussed below, we are replacing the two SLP categorical codes with eight new ones to better re flect the diversity of services furnished. Table 21 provides a complete list of the codes that will be available for reporting functional limitations. With regard to the commenters’ concern that the categories are too broad and this will lead to confusion as to what is being reported, we acknowledge that the categories are broad, but disagree that the use of broad categorie s will result in confusion. Instead, we believe that the result will be the co llection of data that includes information on broadly defined functional limitatio ns. Without more specific input and greater support from the commenters, we do not believe we should create thes e in this final rule with comment period. Moreover, we believe it is important to gain ex perience with a limited number of codes in this new reporting system before we vastly expand th e number of codes that are used. We sought comment on ways to better define the categories and where we received specific suggestions for additional G-codes that were sufficiently develo ped, such as those for SLP (explained below), we included them in our final set of G-codes. We anticipate that we will continue to refine the categories through future notice and comment ru lemaking as we get more information and experience with this system.
Comment : Several commenters pointed out that there were many functional limitations for which there was not a categorical G-code. The American Speech-Language and Hearing Association pointed out the lack of appropriate SLP categories and suggested that we take advantage of the experience that has been gained through the use of its syst em for collecting data on functional limitations in this area. Specifically , they urged us to assign G-codes to the top seven reported functional communication measur es used in National Outcomes Measurement242 System (NOMS). This commenter stated that, us ing this system, we would be able to collect “consistent” and “meaningful” ratings across all settings nationally. Others told us that there we re many conditions and situati ons that our system did not address and that some of these beneficiaries did not exhibit functional limitations that could be easily measured or reported. They cited, as examples, beneficiaries seen for lymphedema management, wound care, wheelchair assessment/fitting, cognitive impairments, and incontinence training. Response : We agree with commenters that the G-codes discussed in the proposed rule did not go far enough in addressing SLP functiona l limitations. After c onsideration of the comments, we also agree that adoption of the most frequently used NOMS measures would be the best way to address this issue and would si gnificantly improve our system in several ways. By using a system familiar to many speech-langu age pathologists, the quality of our data collection will be enhanced and the burden on thos e reporting will be less. We agree that it is reasonable to incorporate categories that are more specific, when appropriate, and note that this is an opportunity to align with ex isting measurement systems. Accordingly, we are replacing the two of the categorical codes relati ng to SLP with seven categorical codes and one “other” code for SLP. (See Table 21.) The seven categorical codes mirror the seven most frequently reported NOMS categories and should be used when appropriate. For all other SLP treatments, th e “SLP Other” category should be used. For functional limitations not defined by the specific categorical codes and for therapy services that are not addressing a particular functional limitation; the “other” G-codes should be used. As we begin collecting data in this init ial year, we will continue to assess the need for additional G-codes, refinement of existing ones, and examine ways to address those situations for which beneficiaries do not have functional limitations. We have addressed in this final rule with comment period those areas for which we have243 adequate information to do so at this time and fo r which an additional burden will not be created. We will continue to refine this system through further notice and comment rulemaking in future
years. Comment : We received mixed feedback in re sponse to our request for comment regarding the use of the ICF subcategories. Some commenters noted that adding more subcategories would result in too many codes and only add to the confusion. At least one other commenter supported subcategory reporting, but di d not suggest which subcategories we should

use. Response : Given the comments received, we will not be implementing reporting by subcategories at this time. Once the system is operational, we will reassess whether subcategory reporting is necessary to provi de the data that we need.
Comment : Some commenters interpreted our propos al to limit each therapy discipline to using only the two codes that re presented the top two reported functional limitations for that discipline and suggested that we allow therapists to use any appropriate functional limitation. Response : We agree with commenters that therapists should be able to use any appropriate functional limitation. In the proposed rule, we indi cated that we developed the 6 categorical codes to correspond with the two mo st commonly reported functional limitations for each of the three therapy disciplines. However, this was only a way of identifying the functional limitations for which we needed codes. To be cl ear, therapists are to use the most appropriate categorical G-code that desc ribes the functional limitation that is the primary reason for treatment without restriction by discipline.
Comment: A few commenters urged us to clarify that therapists using Patient Inquiry by Focus on Therapeutic Outcomes, Inc (FOTO), or another measurement system that provides a composite functional status score, did not need to report on secondary limitations. Response : In assessing this comment, we recogn ized the need to clarify how composite244

functional scores should be re ported. We are clarifying that a composite score should be reported using G8990 (Other physical or occupational pr imary functional limitation, current status, at therapy episode outset and at reporting interv als), G8991(Other physical or occupational primary functional limitation, projected goal status, at therapy episode outset, at reporting intervals, and at di scharge or to end reporting) and G8992 (Other physical or occupational primary functional limitation, discharg e status, at discharge from therapy or to end reporting). Should there be the occasion to report on a second condition after the reporting on the first had ended, the therapis t would use the G-code set for “other subsequent” functional limitation, G8993 - G8896. (3) Number of Functional Limita tions On Which Reporting Occurs We proposed that, using a set of G-codes with appropriate modifiers, the therapist would report the beneficiary’s primary functional limitati on defined as the most clinically relevant functional limitation at the time of the initial therapy evaluation and the establishment of the POC. The projected goal would al so be reported at this time. At specified intervals during treatment, claims would also in clude the current functional status and the goal functional status, which would not typically change during therapy, except as described below. On the final claim for an episode of care, the therapist would repor t the status at this time for this functional limitation and the goal status.. Early results from the DOTPA project suggest th at most beneficiaries have more than one functional limitation at treatment outset. In fact, only 21 percent of the DOTPA assessments reported just one functional limita tion. Slightly more than half (54 percent) reported two, three or four functional limitations. To the extent that the DOTPA finding is typical, the therapist may need to make a determination as to which functional limitation is primary for reporting purposes. In cases where this is unclear, the therapist may choose the functi onal limitation that is most clinically relevant245 to a successful outcome for the beneficiary, the on e that would yield the qu ickest and/or greatest mobility, or the one that is the greatest priority for the beneficiary. In all cases, this primary functional limitation should reflect the predominan t limitation that the furnished therapy services are intended to address. We sought comment on specific issues re garding reporting data on a secondary limitation. Specifically, we requested comment s regarding whether reporting on secondary functional limitations should be required or optional. The following is a summary of the comments we received on the percentage of Medicare therapy beneficiaries with more than one func tional limitation at the outset of therapy and whether reporting on secondary functional lim itations should be required or optional.
Comment : The responses on the number of functi onal limitations being treated showed a wide variation. One commenter trea ting beneficiaries with spinal co rd injuries indicated that 100 percent had more than one func tional limitation, with an average of 10 functional limitations. Another respondent told us th at 50 percent of SLP patients have two or more functional limitations. Another respondent indicated that ne arly 98 percent of patie nts seen by therapists using FOTO were surveyed for only one condi tion. Most commenters recommended that therapists be required to report on ly one functional limitation, esp ecially as we are just beginning to require functional reporting. The commenters stated that it would be burdensome and would pose clinical challenges to require reporting bo th a primary and secondary functional limitation. Others suggested that it would be costly, time intensive and burdensome to report numerous secondary functional limitations. Some stated that reporting on only one functional limitation would not capture sufficient information since tr eatment of multiple functional limitations is interrelated and treatment for these occurs simultaneously, not sequentially. Some commenters suggested allowing the optional reporting of a second or third func tional limitation. Some commenters questioned how functi onal reporting would be handled when the beneficiary was246 being treated by more than one discipline or wh en a substitute therapist treats a beneficiary. Response : In response to comments, we have de cided to limit reporting to one functional limitation at this time. Recognizi ng that therapists treat the patie nt as a whole and work on more than one functional limitation at a time, we belie ve that limiting reporting in this way will make it less burdensome in the situations involving more than one functional limitation. Although many commenters favored the option of reportin g on additional functional limitations when appropriate, we believe that al lowing additional optional repor ting would not produce consistent or useful data on beneficiaries who have more th an one functional limitation that is being treated, and could potentially complicate the use of the da ta we collect for the development of future therapy payment policy. As we seek to improve reporting in future years, we may reconsider whether to permit or require reporting on additional functional limitations. We note that this is a new reporting system designed to gather data on the changes in beneficiary function throughout an episode of care. We are not expecting therapists to change the way they treat patients because of our reporting requirements. We also explained that in situations where treatment continues after the treatment goal is achieved and reporting ended on the primary func tional limitation, reporting will be required for another functional limitation. T hus, reporting on more than on e functional limitation may be required for some patients, but not simultane ously. Instead, once reporting on the primary functional limitation is complete, the therapist will begin reporting on a subsequent functional limitation using another set of G-codes. If this additional functional limitation is not described by one of the specific categorical codes, one of the three “other” codes should be used depending on the circumstances. In response to the comments, we are making several modifications in the G-codes that we proposed, as noted in the re sponses to comments above. To summarize, the G-codes, and their long descriptors, that will be used for reporting functional limitations of beneficiaries are247

listed in Table 21. There are 11 G-codes that describe categorical functional limitation, including seven for SLP services, and three more general G-codes for functional limitations that do not fit within one of the 11 categories. The general categorical code s would be used when none of the specific categories apply or when an a ssessment tool is used that yields a composite score that combines several or many functional m easures, such as is done with the FOTO Patient Inquiry tool, for example. Two of these general G-code sets are to be used for “other” PT and OT services and one for “other” SLP services. In addition, we deleted the requirement to report a G-code to signal that no repor ting was required and thus delete d the G-code that would have been used for this. (For discussion about th e comments on this G-code and our decision to remove this reporting requirement, see section II.F.2.( b).(6).) Therapists would use the code that best describes the functional limitation that is primary to the therapy plan of care.
TABLE 21: G-Codes for Claims-Based Functional Reporting for CY 2013 Mobility: Walking & Moving Around G8978 Mobility: walking & moving around func tional limitation, current status, at therapy episode outset and at reporting intervals G8979 Mobility: walking & moving around func tional limitation, projected goal status, at therapy episode outset, at reporting in tervals, and at discharge or to end reporting G8980 Mobility: walking & moving around func tional limitation, discharge status, at discharge from therapy or to end reporting Changing & Maintain ing Body Position G8981 Changing & maintaining body position f unctional limitation, current status, at therapy episode outset and at reporting intervals G8982 Changing & maintaining body position functional limitation, projected goal status, at therapy episode out set, at reporting intervals, and at discharge or to end reporting G8983 Changing & maintaining body position f unctional limitation, discharge status, at discharge from therapy or to end reporting Carrying, Moving & Handling Objects G8984 Carrying, moving & handling objects f unctional limitation, current status, at therapy episode outset and at reporting intervals G8985 Carrying, moving & handling objects func tional limitation, projected goal status, at therapy episode outset, at reporting in tervals, and at discharge or to end reporting G8986 Carrying, moving & handling objects func tional limitation, discharge status, at discharge from therapy or to end reporting Self Care248
G8987 Self care functional limitation, current status, at therapy ep isode outset and at reporting intervals G8988 Self care functional limitation, projected goal status, at therap y episode outset, at reporting intervals, and at di scharge or to end reporting G8989 Self care functional limitation, discharge status, at discharge from therapy or to end reporting Other PT/OT Primary Functional Limitation G8990 Other physical or occupa tional primary functional lim itation, current status, at therapy episode outset and at reporting intervals G8991 Other physical or occupa tional primary functional li mitation, projected goal status, at therapy episode out set, at reporting intervals, and at discharge or to end reporting G8992 Other physical or occupati onal primary functional limita tion, discharge status, at discharge from therapy or to end reporting Other PT/ OT Subsequent Functional Limitation G8993 Other physical or occupational subseque nt functional limitation, current status, at therapy episode outset and at reporting intervals G8994 Other physical or occupational subse quent functional limitation, projected goal status, at therapy episode out set, at reporting intervals, and at discharge or to end reporting G8995 Other physical or occupational subseque nt functional limitation, discharge status, at discharge from therapy or to end reporting Swallowing G8996 Swallowing functional limitation, curren t status at time of initial therapy treatment/episode outset and reporting intervals G8997 Swallowing functional limitation, proj ected goal status, at initial therapy treatment/outset and at discharge from therapy G8998 Swallowing functional limitation, discharg e status, at discharge from therapy/end of reporting on limitation Motor Speech G8999 Motor speech functional limitation, current status at time of initial therapy treatment/episode outset and reporting intervals G9157 Motor speech functional limitation, proj ected goal status at initial therapy treatment/outset and at discharge from therapy G9158 Motor speech functional limitation, di scharge status at discharge from therapy/end of reporting on limitation Spoken Language Comprehension G9159 Spoken language comprehension functiona l limitation, current status at time of initial therapy treatment/episode outset and reporting intervals G9160 Spoken language comprehension functi onal limitation, projected goal status at initial therapy treatment/outset and at discharge from therapy G9161 Spoken language comprehension func tional limitation, discharge status at discharge from therapy/end of reporting on limitation Spoken Language Expression G9162 Spoken language expression functional limitation, current status at time of initial therapy treatment/episode out set and reporting intervals G9163 Spoken language expression functional li mitation, projected goal status at initial therapy treatment/outset and at discharge from therapy249
G9164 Spoken language expression functional li mitation, discharge st atus at discharge from therapy/end of reporting on limitation Attention G9165 Attention functional limitation, curren t status at time of initial therapy treatment/episode outset and reporting intervals G9166 Attention functional limitation, proj ected goal status at initial therapy treatment/outset and at discharge from therapy G9167 Attention functional limitation, discharge status at discharge from therapy/end of reporting on limitation Memory G9168 Memory functional limitation, current status at time of initial therapy treatment/episode outset and reporting intervals G9169 Memory functional limitation, projec ted goal status at initial therapy treatment/outset and at discharge from therapy G9170 Memory functional limitation, discharge status at discharge from therapy/end of reporting on limitation Voice G9171 Voice functional limitation, current status at time of initial therapy treatment/episode outset and reporting intervals G9172 Voice functional limitation, projec ted goal status at initial therapy treatment/outset and at discharge from therapy G9173 Voice functional limitation, discharge st atus at discharge from therapy/end of reporting on limitation Other SLP Functional Limitation G9174 Other speech language pathology functiona l limitation, current status at time of initial therapy treatment/episode outset and reporting intervals G9175 Other speech language pathology functi onal limitation, projected goal status at initial therapy treatment/outset and at discharge from therapy G9176 Other speech language pathology func tional limitation, discharge status at discharge from therapy/end of reporting on limitation

(4) Severity/Complexity Modifiers We proposed that for each functional G-code used on a claim, a modifier would be required to report the severity/complexity for that functional limitation. We proposed to adopt a 12-point scale to report the severity or comple xity of the functional limitation involved. The proposed modifiers are listed in Table 22. TABLE 22: Proposed Modifiers Modifier Impairment Limitation Restriction Difficulty250
Modifier Impairment Limitation Restriction Difficulty XA 0% XB Between 1-9% XC Between 10 - 19% XD Between 20 - 29% XE Between 30 - 39% XF Between 40 - 49% XG Between 50 - 59% XH Between 60 - 69% XI Between 70 - 79% XJ Between 80 - 89% XK Between 90 - 99% XL 100%

We noted that there are many valid and reliab le measurement and a ssessment tools that therapists use to inform their clinical deci sion-making and to quantify functional limitations, including the four assessment tools we di scussed in CY 2011 PFS rulemaking that produce functional scores – namely, the Activity Measur e – Post Acute Care (A M-PAC) tool, the FOTO Patient Inquiry, OPTIMAL, and NOMS. We lis t these four tools as recommended for use by therapists, though not required, in the outpatien t therapy IOM provision of the Benefits Policy Manual, Chapter 15, Section 220.3C “Documen tation Requirements for Therapy Services .” We suggested that the scores from these and other measurement tools alrea dy in use by therapists that produce numerical or percentage scores be mapped or crosswalked to the proposed 12-point severity modifier scale. In assessing the ability of therapists to provide the required severity information regardless of what assessment tool or combinatio n of tools they use, if any, we considered the comments received on the CY 2011 PFS proposed rule discussion. These indicated that we needed greater granularity in our severity scale so that the changes in functional limitation over the course of therapy could be more accurately reflected. Specifically, most commenters on the251 CY 2011 proposed rule favored the 7-point scal e over the 5-point ICF-based scale. They indicated that they preferred a scale with more severity levels and equal increments since it would allow the therapist to document smaller changes that many thera py beneficiaries make towards their goals. Believing that neither the 5- or 7-point sc ales would be adequate for this reporting system, we developed and proposed a 12-point scale that we be lieved was an enhancement over the 7-point scale. We thought it addressed concerns that those commenting on the CY 2011 options had raised regarding the 7-point scale. We thought that a more sensitive rating scale (one with more increments) had the advantage of demonstrating the progress of beneficiaries with conditions that improve slowly, such as thos e recovering from strokes or with spinal cord injuries. In addition, we be lieved that the proposed scale’s 10-percentage point increments would make it easier for therapists to convert composite and overall scores from assessment instruments or other measurement tools to this scale. The following is a summary of the comments we received regarding our proposal for a 12-point scale to capture the severity/complexity of beneficiaries’ f unctional limitations.
Comment: Several commenters stated that no t all tests and measurement tools that therapists use could be easily crosswalked to any single numerical sc ale, stating that, for example, some tests and measures of functional limitations use ordinal scales. Further, the scores from some tests that are not linear or prop ortional to each other ar e not easily translatable to the 12-point scale. Some commenters pointed out the problem s of developing a single score when more than one tool is used. Some comme nters noted that there are a wide variety of therapy measurement tools that are used to in form clinical decision making and these are not measures that typically produce a functional assessm ent. Further, these commenters told us that combining the results of multiple measures make it extremely difficult to quantify beneficiary function and, as such, said it will be very difficu lt to crosswalk this type of information to a252 severity scale. And, many of these commenters expressed con cerns about how therapist will implement the use of our severity/complexity modifi er scale; they noted th at much education is needed for therapists to understand the selecti on of a severity modifier. One commenter questioned whether aggregated subjective and obj ective data would be valid or usable by CMS. Response : It is essential that the data reporte d on functional limitations be grouped using the same numeric scale. Moreover, we believe that is easier for t hose reporting data on functional limitations to use ranges of percenta ges rather than the absolute values. We acknowledge that therapis ts will incur some challenges when initially adopting our system as they learn how to translate the information obt ained through various test s and measures to a particular modifier scale. However, as therapists gain experience in doing so, we anticipate that these translations will become easier and a normal part of their evaluative and treatment processes. Moreover, we are hopeful that fort hcoming modifications fro m tool sponsors or others will make it easier for therapists to repo rt the functional limitations measured by these tools, such as modifying the tool so the result s match the Medicare severi ty/complexity scale or issuing instructions or guidance on translating the results to th e Medicare severity/complexity scale. We also expect that some translation tool s are likely to become available. We are hopeful that forthcoming guidance and tran slation tools from tool sponsors and others will clarify some of translation questions th erapists have regarding the Medicare se verity scale. Given that it is essential for our purposes to have a severity/compl exity scale, we are adop ting one in this final rule. With regard to education, CMS will make information about the severity/complexity scale, as well as other aspects of our new system, widely available to therapists. It will be incumbent upon individual therapists to learn how to transl ate the score from a singular assessment tool or the combined results from multiple tests/measur es along with other information regarding their patient’s functional limitation to the Medicare scale. Finally, we acknowledge that a system that combines objective and subjective data is not ideal. However, at this time it appears that there is253 not an alternative. We will continue to refine and improve this system.
Comment : Some commenters offered alternat ive suggestions to the use of a severity/complexity scale. Se veral commenters suggested that we use the secondary diagnoses on claims instead. Others suggested capturing th e medical complexity of a beneficiary using other indicators, such as E/M codes or co-morbidities. Response : We appreciate these suggestions. While we are able to collect secondary diagnosis data from claims, we know from prior studies that di agnoses alone cannot predict the amount of therapy services needed. We do not believe that diagnoses and comorbidities measure functional limitations, which the st atute requires us to collect. Nor do we believe using existing or therapy-specific E/M codes would provide the data on func tional limitations that we are seeking to collect. We do, however , believe that these elements ma y provide additional data that could contribute to our analysis of payment alternatives. As we consider refinements to the claims-based data collection system in future years we will consider these additional data elements.
Comment : Commenters had differing views on the use of the proposed 12-point scale to convey the severity of the beneficiary’s functio nal limitations. Those supporting the use of the proposed 12-point scale st ated that it was more sensitive a nd so better reflected change in a beneficiary’s functional limitation. For example, commenters using FOTO said that they would not have problems adopting our proposed 12-point scale because they receive a composite score from FOTO, based on the patient’ s functional survey results, which can be easily mapped as a percentage of overall beneficiary function. Othe r commenters suggested th at the 12-point scale we proposed was too complicated and had too many levels. Some of these commenters also stated that therapists were not familiar with such a scale. Several commenters believed that we should modify the 12-point scale to a 10-point one by eliminating the separate modifiers for zero and 100 percent because they believed it would be more recognizable and easier for therapists to254 use. Many suggested that we use the 7-point scale discussed in the CY 2011 rulemaking. A couple of these commenters thought that this 7-point scale was a va lid and reliable one. Another commenter added that a 7-point scale is used by many outcome tools, such as NOMS, although no other examples of a tool usi ng a 7-point scale were provide d. One commenter was opposed to a severity/complexity scale but sugg ested that if one was used, it shoul d be a 5- or 7-point scale. Response : After reviewing the comments, it is cl ear to us that, given the diversity of views among therapy professiona ls, the range in functional li mitations being measured, the variability of beneficiary condi tions being treated and the pl ethora of assessment tools and instruments being used, the transl ation of functional information to any scale used is likely to require adjustments by some therapists. Althoug h we proposed a 12-point scale as we thought it would be easier to use and provi ded more sensitivity, a majority of commenters favored the 7- point scale over the 12-point sc ale. After consideration of the many comments on the use of a 12-point scale, we have determined that a 7-po int scale as preferred by commenters will provide appropriate data for our analysis . Accordingly, are finalizing th e 7-point scale in Table 23.
Comment : Some commenters read our proposal to require that therapists use one of the IOM-recommended assessment tools, and thought that we should allow therapists to assign a severity/complexity modifier using their clinical judgment when a functiona l assessment tool is not used. Other commenters noted that physi cal and occupational therapists typically use multiple measurement tools during the evaluative process to inform clinical decision making; and, that clinical judgment is needed to combine these results to determin e a functional limitation percentage. One commenter pointed out th at the IOM outpatient coverage guidelines recommend, but do not mandate, the use of stan dardized measurement instruments and sought guidance as to how the modifier scale would apply to a therap ist who satisfies documentation guidelines but does not use a standardized m easurement instrument that produces a global functional score.255
Response : We appreciate commenters’ concerns that our proposed policy would require therapists to use a functional assessment tool to determine the overall degree of functional impairment. This was not our intent. However, when one of the four functional assessment instruments is not utilized, we require as part of our IOM Documentation Guidelines , that the therapist documents using objective measures th e beneficiary’s physical functioning. We are also aware that use of one of the four functiona l instruments is not wide spread; and that physical and occupational therapists typically use multiple objective tests and measures to establish and compare a beneficiary’s physical function and progress throughout th e therapy episode. As such, we recognize that a therapist’s judgment is critical in determ ining how to best measure their patient’s functional impairment and how to a ssimilate the various necessary objective findings to ascertain a certain percentage of function that can be translated to the Medicare severity scale. Our requirements for documenting the beneficiary’ s functional status were established prior to this data collection effort, and the primar y purpose for measuring functional impairment continues to aid the therapist in furnishing ther apy services. Our data collection system is designed to collect data that is developed in the evaluative pr ocess and assessed throughout the course of treatment, not to prescribe how or wh at measures therapists use to assess functional impairment or deliver services. Accordingl y, it is acceptable for therapists to use their professional judgment in the sel ection of the appropriate modifi er. Our IOM provisions already assert that when assessing the level of func tional impairment, the therapist uses his/her professional judgments in addition to the objec tive measures and accepted methodologies that are recognized in the therapy community and in professional practice guidelines. Because there will be many cases for which one single functional measurement tool is not available or clinically inappropriate, therapists can use their clinical j udgment in the assignment of the appropriate modifier. Therapists will n eed to document in the medical record how they made the modifier selection so that the same process can be followed at succeeding assessment256

intervals.
Comment : Many commenters evaluated our proposed 12-point scale as if it was itself to be used as an assessment tool, rather than simply a scale to report result s of assessments. Some of these commenters also warned us that the 12-p oint scale could not give us valid and reliable data to use as an alternative payment system fo r therapy services unless a single assessment tool were used. Response : We appreciate the views expressed by the many commenters. However, the 12-point scale was not inte nded to be used as an assessment tool. Rather, it was intended to be used to express the beneficiary’s functional limita tion in terms of a percen tage of 100 total points so that there is a uniform scale for the degree of functional limitation. In other words, the scale that is used to report the degr ee of impairment would not affect the validity of the data. The reported data are as valid and reliable as th e assessment tool or instrument (at times in combination with the therapist’s judgment) that wa s used to develop the score. We also realize that there are limitations to the data that we will co llect, in part because it is not all derived from one consistent, assessment tool.
Comment: Commenters noted that pain is a clini cal complexity that is factored in when the beneficiary and therapist plan the course of treatment, but is not factored in to the proposed scale. Response : We believe that the commenter meant that pain is a definite limiter of function and is difficult to measure and hard to qu antify. However, we believe that pain and the functional limitations that it e ngenders can be captured by our se verity scale. There are many valid and reliable measures that a therapist can use to quantify the functional limitations of painful conditions. In response to the comments, we are adopti ng the following 7-point severity/complexity scale to report the severity of the beneficiary’s functional impairment, which is based upon the257 scale developed as part of the STATs project. TABLE 23: Severity/Compl exity Modifiers for CY 2013 Modifier Impairment Limitation Restriction CH 0 percent impaired, limited or restricted CI At least 1 percent but less than 20 percent impaired, limited or restricted CJ At least 20 percent but less than 40 pe rcent impaired, limited or restricted CK At least 40 percent but less than 60 pe rcent impaired, limited or restricted CL At least 60 percent but less than 80 pe rcent impaired, limited or restricted CM At least 80 percent but less than 100 percent impaired, limited or restricted CN 100 percent impaired, limited or restricted (4) Assessment Tools In the proposed rule we noted that therapists frequently us e assessment tools to quantify beneficiary function. FOTO and NOMS are two such assessment t ools in the public domain that can be used to determine a score for an assessmen t of beneficiary function. Therapists could use the score produced by such instruments to sel ect the appropriate modifier for reporting the beneficiary’s functional status. Although we recommend the use of four of these functional assessment instruments to determine beneficiar y functional limitation in the IOM, we did not propose to require the use of a particular functional assessment tool to determine the severity/complexity modifier. We explained ou r reasons for not doing so in the proposed rule saying “Some tools are proprietary , and others in the public do main cannot be modified to explicitly address this data collection project. Further, this data collection effort spans several therapy disciplines. Requiring a specific instru ment could create burdens for therapists that would have to be considered in light of any potential improvement in data accuracy, consistency and appropriateness that such an instrument would generate.” We noted that we might reconsider this decision once we have more experience with claims-based data collection on beneficiary function associated with furnished therapy services. We sought public comment on the use of assessment tools. In particular, we we re interested in feedback regarding the benefits and burdens associated with use of a specific to ol to assess beneficiary functional limitations.258 We requested that those favoring a requirement to use a specific tool provide information on the preferred tool and describe why the tool is preferred. The following is a summary of the comment s we received regarding the use of assessment tools and the benefits and burdens asso ciated with use of a specific tool to assess beneficiary functional limitations.
Comment : Many commenters appreciated that we r ecognized the need to use consistent and objective measurement tools to quantify beneficiary function. All commenters who addressed assessment tools agreed that there is not currently a single assessment tool that would meet the diverse needs of beneficiaries receiv ing therapy services, a nd most did not recommend requiring the use of a single tool. However, many commenters stated we would be ineffective in reaching our data collection goals without prescr ibing some rules about assessing function; and thus suggested alternatives due to concerns of consistency and validity of the data. MedPAC noted that collecting data without a tool “would generate large amounts of data, and not provide clear information on the patients’ limitations or f unctional status.” MedPAC elaborated that variations among the assessment methods used by therapists “would potentially impede the utility of such data for policymakers.” Commenters found the following potential drawb acks to our proposal to allow therapists to choose the assessment tool(s ) (or use their professional judgment) to determine the complexity/severity modifier. Commenters st ated that the current proposal would collect individual level data that is not comparable among groups of benefi ciaries or providers. Commenters also stated that gathering data on beneficiary condition, functional limitation, and progression necessitates the use of one standardized collection tool by all therapists. One commenter revealed that the same beneficiary could obtain widely dist inct modifier scores depending on the tool used. Further, a co mmenter acknowledged that there are over 400 different measurement tools used by physical therapists, many of which only measure one259 domain of function. Additionally, another comment er urged us to provide more instruction on how each tool interfaces with the complexity/sev erity scale and provide crosswalks and guidance for each tool to promote consistency in the data collected. Commenters suggested the following alternativ es to our proposal to address the potential drawbacks they identified. Commenters support ed endorsing a small number of standardized tools with proven validity, reliability, and responsi veness that would be distinct for each therapy discipline. The American Speech-Language and Hearing Association (ASHA) urged we adopt NOMS and a 7-point severity scal e specifically for SLP to recogni ze the distinctiv eness of the discipline and record meaningf ul outcomes for SLP beneficiar ies. Many commenters supported the use of FOTO stating that it measures a br oad scope of conditions reliably, results in a composite score, and creates little undue burden to report. Those commenters also stated that FOTO is already the tool of c hoice for their respective providers. Two commenters suggested deve loping a list of approved tools for specific beneficiary populations and settings. A nother commenter suggested assigning G-codes to specific assessment tools so that the data could be compared. As a future alternative, a few commenters proposed developing core items that could be used in any tool to standardize data collection. MedPAC suggested that “CMS c onsider developing an instrument that collects the necessary information that would allow Medicare to cate gorize beneficiaries by c ondition and severity in order to pay appropriately” and pointed to the “Reason for Therapy” form used in the DOTPA study as a starting point, noting th at it is “concise, easy to assess and document for clinicians, and collects information on function and limitati ons across three therapy disciplines.” Response : We continue to recommend the use of four functional assessment tools to determine beneficiaries’ functional limitations. In addition, when these tools are not used, we require the use of objective measures to document the functional status of beneficiaries. We continue to believe that no one tool currently meets the needs of all three therapy disciplines;260 and, therefore, we are not requiring the use of a ny one specific assessment tool, or even the use of any assessment tool. We acknowledge that be cause of the use of the variety and kinds of assessment tools and other measurement instru ments, including the use of a therapist’s professional judgment, the value of the data we co llect under this system will have limitations. However, we believe that the data we gather wi ll assist us in taking a first step towards an improved payment system. We appreciate the comments providing info rmation on the benefits of using specific tools, such as NOMS and FOTO. However, at this time we do not believe that they are sufficiently widely used to require the use of one of these tools. In this final rule with comment period, we are not requiring the use of a speci fic assessment tool. We are continuing to encourage, but not require, the use of assessment tools in the IOM. We did, however, adopt G-codes and a modifier scale for SLP that are consistent with NOMS so it is possible to move to a standardized tool for SLP in the future. We will consider the possibility using coding to identify the specifi c functional assessment tool used in subsequent refinements. As noted above, therapists can also use their professional judgment in determining the percentage of functional lim itations in conjunction with obj ective data from evaluations and assessments and the subjective repo rts from beneficiaries. (5) Reporting Projected Goal Status We proposed that the therapist’s projected goa l for the beneficiary’s functional status at the end of treatment would be reported on the fi rst claim for services, periodically throughout an episode of care, and at discharge from therapy. The following is a summary of the comme nts regarding goal reporting.
Comment : Of those commenting on goal status, most objected to the co llection of goal data, particularly during the firs t year of data collection. Commenters noted that reporting on goals was not specified as part of the claims-based data collec tion effort required by MCTRJCA.261

Some stated that it would be a significant practice change to re port goal data, involving changes to medical documentation, electronic health records, and billing processes. Commenters stated the identification and reporting of goals raised seve ral clinical issues, such as the variability in goals among therapists, the need to change goals ove r the course of treatmen t, and the fact that therapists often set several goals (for example, short and long-t erm goals) for each beneficiary. Others noted that using goal data to classify a group of benefici aries would be flawed because therapists create goals specific to the individual . One commenter noted th at if goals influence payment, therapists could set the goal low or high to induce ongoing therapy and therefore the data would not be useful. As a result of th ese factors, many commenters believed data reporting on therapy goals would not provide reliable and useful information. In addition, a number of commenters stated that the proposal did not clearly express the inte nt of collecting goal data and many commenters expressed conc erns about how we would use this data. Some commenters suggested that we clarify that the functional status data w ould be used only to track a beneficiary’s progression rather than for any other purposes, such as making comparisons across beneficiaries, therapists, or set tings. Several commenters expre ssed concern that the reporting of goals implied an improvement standard and that care would be denied to beneficiaries who improved slowly or not at all. Alterna tively, one commenter supported our proposal for reporting of a projected goal, as well as periodic updates of the be neficiary status in the context of that goal. Response : We understand the commenters’ co ncerns about the complexity and intricacies of goal reporting. However, we curr ently require in the Benefit Policy Manual (Chapter 15, section 220.1.2 ) that long-term treatment goals be developed for the entire episode of care. Further, we specify that the projec ted goals should be measurable and pertain to identified functional limitations, and that these goals also need to be documented in the medical record. Since many of these goal requirements already exist, the additional work imposed by262 this requirement would be for th e therapist to establish the percentage of functional limitation for projected for this goal at the end of the th erapy episode and translate the goal to the Gcode/modifier scale. We understand that the cl aims-based reporting is a change for therapists; however, these adjustments in operations will yield meaningful information on beneficiary functional status. We appreciate the recommenda tion to delay goal reporting for a year, but we believe that it is important to include goal data to gather a complete descri ption of a beneficiary’s functional status. At this time, we intend to use the projected goal to have an unders tanding of therapists’ ability to project the likely progress a benefi ciary will make. We ultimately may employ these data to help us develop proposal s to improve payment for thera py services, but do not anticipate using the goal data for purposes of payment or c overage decisions. In cas es where the therapist does not expect improvement, such as for those individuals receiving maintenance therapy, the reported projected goal status will be the same as current status. We appr eciate that commenters raised concerns about potential ambiguity of the description of the proposal on progress and outcomes but, given as we have clarified in th is final rule with comment period, goal reporting does not establish an improvement st andard. In fact, it allows the therapist to state at the outset the expectations. We understand there will be wi de variability in goals. Since these goals are used in beneficiary treatment, as well as for re porting, we do not expect therapists to establish goals purely to make themselves look better. Recognizing the limitations of the collected goal data, we still believe it will be useful to us. Therefore, we are finalizing our requirement for reporting of goal G-codes on the claims form along with the related severity modifier for that goal. (6) Reporting Frequency We proposed to require claims-based reporting in conjunction with th e initial se rvice at the outset of a therapy episode, at established inte rvals during treatment, and at discharge. As263 proposed, the number of G-codes required on a part icular claim would have varied from one to four, depending on the circumstances. We provide d the following (Table 24) graphic example of which codes would have been used for periodic reporting. This exampl e represents a therapy episode of care occurring over an extended period, such as might be typical for a beneficiary receiving therapy for the late effects of a str oke. We chose to use an example with a much higher than average number of treatment days in order to show a great er variety of reporting scenarios. TABLE 24: Example of Proposed ReportingEvaluation/Treatment Day1, Begin Reporting Period#1End Reporting Period #1Begin Reporting Period #2Claim for treatment days5 and 6 in Period #2End Reporting Period #2Begin Reporting Period #3Discharge/End ofreporting on PrimaryFunctional LimitationEnd Reporting Period #3

Primary Function Status GXXX1 – Current X X X X X GXXX2 – Goal X X X X GXXX3 – Discharge X Secondary Function GXXX4 – Current X X X X GXXX5 – Goal X X GXXX6 – Discharge No Functional Reporting Required GXXXX7 X

● Outset . As proposed, the first reporting of G-codes and modifiers would occur when the outpatient therapy episode of care begins. Th is would typically be the date of service when the therapist furnishes the evaluation and develo ps the required plan of care (POC) for the beneficiary. At the outset, the therapist would use the G-codes a nd modifiers to report a current status and a projected goal fo r the primary functional limitati on. We indicated in the proposal264 that if a secondary functional li mitation would need to be reported, the same information would be reported using G-codes and a ssociated modifiers for the secondary functional limitation. The following is a summary of comments on th e frequency of reporti ng at the outset.
Comment: All commenters that addressed freque ncy of reporting ag reed that reporting should occur at the outset of the therapy episode of care. Although commenters agreed with reporting at the outset, many r ecommended removing the requireme nt to report the projected goal status. (Comments on reporting projec ted goal status are discussed above.) Response : We are finalizing the requirement to re port current status and projected goal status at the outset of therapy.

● Every 10 Treatment Days or 30 Calendar Days, Whichever Is Less . We proposed to require reporting once every 10 treatment days or at least once during each 30 calendar days, whichever time period is shorter. As we explai ned in the proposed rule, the first treatment day for purposes of reporting would be the day that the initial visit takes place. The date the episode of care begins, typically at the evaluation, even when the therapis t does not furnish a separately billable procedure in addition to the evaluation on this day, woul d be considered treatment day one, effectively beginning the c ount of treatment days or cale ndar days for the first reporting period. A treatment day is defined as a calendar da y in which treatment occurs resulting in a billable service. Often a treatment day and a th erapy “session” (or “visit”) may be the same, but the two terms are not interchangeab le. For example, a beneficiary might receive certain services twice a day, although this is a rare clinical scenario, these two diffe rent sessions (or visits) on the same day by the same discipline ar e counted as one treatment day. We explained that the proposal would require that on the claim for service on or before the 10 th treatment day or the 30 th calendar day after treatment da y one, the therapist would only report the G-code and the appropriate modifier to show the beneficiary’s cu rrent functional status265 at the end of this reporting peri od under the proposal. We added that the next reporting period begins on the next treatment day and that th e time period between the end of one reporting period and the next treatment day does not c ount towards the 30-calenda r day period. On the claim for services furnished on this date, the ther apist would report both th e G-code and modifier showing the current functional stat us at this time along with the G-code and modifier reflecting the projected goal that was identified at the outse t of the therapy episode. This process would continue until the benefici ary concludes the course of therapy treatment. Further, we proposed that on a claim for a se rvice that does not require specific reporting of a G-code with modifier (that is, on a claim for therapy services within the time period for which reporting is not required), GX XX7 would be used. By using this code, the therapist would be confirming that the claim does not require spec ific functional reportin g. This is the only Gcode that we proposed to be repor ted without a severity modifier. As we noted in the proposed rule, we propos ed the 10/30 frequency of reporting to be consistent with our existing timing requirements for progress reports. These timing requirements are included in the Documentation Requirements for Therapy Services (see Pub. 100-02, Chapter 15, Section 220.3, Subsection D). By making thes e reporting timeframe s consistent with Medicare’s other requirements, therapists w ho are already furnishing therapy services to Medicare outpatients would have a familiar framework for successfully adopting our new reporting requirement. In addition to reflect ing the Medicare required documentation for progress reports, we believe th at this simplifies the process and minimizes the new burden on therapists since many therapy epis odes would be completed by the 10 th treatment day. In 2008, the average number of days in a therapy episode was 9 treatment days for SLP, 11 treatment days for PT, and 12 treatment days for OT. Unde r the proposal, when re porting on two functional limitations, the therapist would re port the G-codes and modifiers for the second condition in the manner described above. In othe r words, at the end of the re porting period as proposed, two G-266 codes would be reported to show current functio nal status – one for the primary (GXXX1) and one for the secondary (GXXX4) limitation. Sim ilarly as proposed, at the beginning of the reporting period four G-codes would be reported. GXXX1 and GXXX4 would be used to report current status for the primary and secondary f unctional limitations, resp ectively; and, GXXX2 and GXXX5 would be used to report the goal st atus for the primary and secondary functional limitations, respectively. We noted that the proposal required that th e same reporting periods be used for both the primary and secondary functional limitation. We added that the therapist can accomplish this by starting them at the same time or if the secondary functional limitation is added at some point in treatment, the primary functional limitation’s re porting period must be re-started by reporting GXXX1 and GXXX2 at the same time the new se condary functional limitation is added using GXXX4 and GXXX5. Further, for those therapy trea tment episodes lasting longer pe riods of time, the periodic reporting of the G-codes and associated modifiers would reflect any progre ss that the beneficiary made toward the identified goal. In summary, we proposed to require the reporting of G-codes and modifiers at episode outset (evaluation or in itial visit), and once ever y 10th treatment day or at least every 30 calendar da ys, whichever time period is less, and at discharge. We noted that we believed it was important that the requirements for this reporting system be consistent with the requirements fo r documenting any progress in the medical record as specified in our manual. Given the current proposal for claims-bas ed data collection, we believe it is an appropriate time to reassess the manual requirements. We sought comment on whether it would be appropriate to modify the periodicity of the progres s report requirement in the IOM to one based solely on the number of treatment days, such as six or ten. We noted that if a timing modification was made for progre ss reporting, a corresponding change would be made in the functional reporting interval.267 The following is a summary of the comments we received on our proposal to require reporting every 10 treatment days or 30 calendar days, whichever is less , and whether it would be appropriate to modify the progress report requ irement in the IOM to one based solely on the number of treatment days, such as six or ten, and the clinical impact of such a change.
Comment : Although many commenters appreciated ou r effort to align the claims-based reporting with existing requirement s for a progress report, several commenters requested that we recognize the significant time burden of the new reporting frequency and that we ameliorate some of the burden with a simp lification of the existing manual requirement. Commenters in favor of reporting every 10 treatmen t days explained that using treatment days as compared to calendar days is more easily programmed into software systems and in accord with certain therapist’s billing practices. A couple of other commenter s supported reporting every 30 calendar days as this accommodates therapists wo rking in settings where claims are required to be submitted on a monthly basis, such as hospita ls, rehabilitation agencies and SNFs. Several commenters objected to the periodi c reporting and suggested that reporting only at the outset and at discharge of therapy would be sufficient to capture a beneficiary’s functional progression. A few of those commenters were okay with the proposed 10 treatment day or 30 calendar day reporting timeframe, if periodic claims reporting is necessary. A few commenters urged us to eliminate the re quirement for functional status reporting at the visit subsequent to the progr ess report because a beneficiary’ s status probably would remain the same unless there is a si gnificant gap between visits. We received many comments concerning the reporting of GXXX7; which we proposed to be used to indicate that the therapist conf irms functional reporting not required. These commenters stated that the repor ting of GXXX7, which is required for claims with dates of services when a functional status measure is not collected, would be unnecessary and burdensome, especially for daily billers. Th ey urged us to require reporting only when a268 functional status is required to be reported. Further commenters stated that there was no purpose for this G-code. Response : Based on the public comments, we are making several changes. We believe that reporting every 10 treatment days would be less burdensome for therapists than the proposed 10 treatment days/30 calendar days. We believe a 10 - treatment day reporting period is straightforward for therapists to track, allows for better monitoring of changes in functional status, and is more easily adopted within our curr ent claims processing systems. Therefore, we are finalizing the requirement that G-codes and associated modifiers are reported at least once every 10 treatment days and we will modify the IOM to establish the same timing requirement for progress reports. By making this change, we no longer need the therapis t to report functional status at the visit subsequent to the end of a reporting period to signal the beginning of a new reporting period. So in response to comments, we have eliminated the requirement to report data at the start of a new reporting period. After assessing the comments, we agree that reporting a G-code (GXXX 7) to tell us that no reporting is required would not provide meaningful data a nd would pose an additional burden for therapists and therapy providers. When pr oposed, we believed it would be convenient for therapists to use the code to indicate that this wa s a claim for therapy servi ces that did not require the functional reporting because it would assi st them in complying with the reporting requirements and would assist us in enforcing them. When we reassessed the issue based on feedback from commenters, it was clear that the “no report due” code would not aid us in enforcing the requirements as we would still have to verify that claims with the proposed GXXX7 were in fact claims that did not require reporting. Sin ce commenters pointed out that not only would it not assist them, but would in f act burden them, we have decided not to include this code. Accordingly, we are also modifying our proposal to remove the requirement to report a “no report due” code on claims when functiona l reporting is not due, such as between the first269 and the tenth day of service. We expect these changes will significantly reduce the frequency of required reporting during a therapy episode and believe they will appropriately simplify the claims-based reporting system.

● Discharge. In addition, we proposed to requ ire reporting of the G-code/modifier functional data for the current st atus and for the goal at the conc lusion of treatment so that we have a complete set of data for the therapy epis ode of care. Requiring th e reporting at discharge mirrors the IOM requirement of a di scharge note or summary. This set of data would reveal any functional progress or improvement the benefici ary made toward the projected therapy goal during the entire therapy episode. Specifically, information on the beneficiary’s functional status at the time of discharge shows whether the be neficiary made progress towards or met the projected therapy goal. As we noted in th e proposed rule, the impos ition of this reporting requirement does not justify scheduling an addi tional and perhaps medically unnecessary final session in order to measure the beneficiary’s function for the sole purpose of reporting. Although collection of discharge data is important in achievi ng our goals, we recognize that data on functional status at the time therapy concludes is so metimes likely to be incomplete for some beneficiaries receiving outpatient thera py services. The DOTPA project has found this to be true. There are various reasons as to why the therapist would not be able to report functional status using G-codes a nd modifiers at the time therapy ends. Sometimes, beneficiaries may discontinue therapy without alerting their therapis t of their intention to do so; simply because they feel better; they can no longer fit therapy into their lif e, work, or social schedules; a physician told them further therapy was not nece ssary; or their transportation is unavailable. Whatever the reason, there would be situations where the therapy ends without the planned discharge visit taking place. In these situations, we said that we would not require the reporting at discharge. However, we encourage therap ists to include discharge reporting whenever possible on the final thera py claim for services.270 Since the therapist is typically reassessing th e beneficiary during the therapy episode, the data critical to the severity/complexity of the functional measure may be available even when the final therapy session does not occur. In these instances, the G-codes a nd modifiers appropriate to discharge should be reported when the final cl aim for therapy services has not already been submitted. We sought feedback on how often the ther apy community finds that beneficiaries discontinue therapy without the th erapist knowing in advance that it is the last treatment session and other situations in which the discharge data would not be av ailable for reporting. The following is a summary of the comments we received regarding the proposal to require reporting of the G-code/mod ifier functional data at the conclu sion of treatment so that we have a complete set of data fo r the therapy episode of care.
Comment : In addition to outset reporting, a majo rity of commenters supported claimsbased reporting at discharge of the therapy episode of care. With regard to the number of beneficiaries who stop therapy services without notice, the responses varied from about 12 percent for beneficiaries being treated for a spin al cord injury to 26 percent of patients with orthopedic conditions in a large system of outpatient therapy clinics. Many commenters who supported discharge reporting recomme nded that if the beneficiary misse s his or her last visit, the therapist should be exempt from reporting the functional status at discharge. Another commenter believed, however, that having a separate G-code in each set to report discharge status is unnecessary; the commenter further stated that the last reported current status and goal status Gcodes could be used to repr esent the end of treatment. Response : Although we recognize that there may be some challenges with discharge reporting, this information is important for our pur poses to complete the data set for each therapy episode; and, thus, we are maintaining the requir ement. We do not agree with the commenter who suggested that we could simply use the last re ported current status to represent the status at271 discharge since this may not be an accurate repr esentation of the beneficiary’s status at the time of discharge. However, in those cases where th is functional status is derived from a patient survey, for example, FOTO, Am-PAC or OPTIMAL, and the survey is routinely sent to the patient who misses his/her final treatment, the ther apist should report this data once subsequently gained, on the final bill for servic es unless the bill for the last treatment day has already been submitted. There are instances where not reporting the discharge status would make it impossible for us to distinguish the start of the reporting for a new or subsequently-reported functional limitation or the treatment for a new therapy episode in the data. We are finalizing our proposal to require discharge re porting (except in cases where therapy services are discontinued by the beneficiary prior to the planned discharge visit) using the discharge G-code, along with the goal status G-code, to indica te the end of a thera py episode or to signal the end of reporting on one functional limitation, while further therapy is necessary for another one.

● Significant Change in Beneficiary Condition. We proposed that, in addition to reporting at the intervals discusse d above, the G-code/modifier meas ures would be required to be reported when a formal and medically necessary re -evaluation of the beneficiary results in an alteration of the goals in the beneficiary’s POC. This could result from new clinical findings, an added comorbidity, or a failure to respond to treat ment. We noted that this reporting affords the therapist the opportunity to expl ain a beneficiary’s failure to progress toward the initially established goal(s) and permits eith er the revision of the severity st atus of the existing goal or the establishment of a new goal or goals. Under th e proposal, the therapist would be required to begin a new reporting period when submitting a cl aim containing a CPT code for an evaluation or a re-evaluation. This functi onal reporting of G-codes, along w ith the associated modifiers, could be used to show an increase in the sever ity of functional limitations; or, they could be used to reflect the severity of newly identified functional limitations as delineated in the revised plan of care.272 The following is a summary of the comments we received regarding the proposal that in addition to reporting at the interv als discussed above, the G-code and related modifier would be required to be reported when a formal and medically necessary re-evaluation of the beneficiary results in an alteration of the goa ls in the beneficiary’s POC.
Comment : One commenter recommended that in stead of requiring periodic reporting throughout a therapy episode that we require it only at the ti me of a re-evaluation. This commenter believed that capturing the functional in formation using G-codes within the treatment episode is burdensome and reporting at the tim e of the progress report would put unnecessary emphasis on a therapist capturing a cha nge in a beneficiary’s assessment. Response : We did not receive comments objecting to claims-based reporting at the time that a re-evaluation code is bill ed for PT or OT or a subseque nt or second evaluation code is billed for SLP. Therefore, we are finalizi ng the requirement for functional reporting when a formal and medically necessary re-evaluation, for PT or OT, or a second or repeat SLP evaluation of the beneficiary is furnished. We are requiring claims-based reporting in conjunction with the evaluation at the outset of therapy, on or before each 10th treatment day throughout therapy, and at therapy discharge (e xcept in cases where therapy services are unexpectedly discontinued by the beneficiary pr ior to the planned di scharge visit and the necessary information is not av ailable) or to signal the e nd of reporting on one functional limitation. On a claim, two G-codes would be required depending on the reporting interval. Table 25 shows a revised example of which codes are used for specified reporting under our final policy. We should note that this example util izes the mobility functional limitation G-codes, G8978 - G8980 for “walking and moving around” and the “Other or Primary” G-codes, G8990 - G8992 and is for illustrative purposes only. This table not only shows how the final reporting works but by comparing it to the table showing the same details for reporting under the proposed policy one can see how much less reporting is re quired. Any of the other functional limitation273

G-code sets listed in Table 21 w ould also be applicable here. TABLE 25: Example of Required ReportingEvaluation/Treatment DayOne, Begin Reporting Period#1End Reporting Period #1Reporting Period #2 BeginsNext Treatment DayClaim for treatment days5 and 6 in Period #2End Reporting Period #2Reporting Period #3 BeginsNext Treatment DayDischarge /End of reporting onWalking & Moving AroundFunctional LimitationBegin Reporting Period #1 forOther Primary

Mobility: Walking & Moving Around G8978 – Current X X X G 8979– Goal X X X X G8980 – Discharge X Other Primary G8990 – Current X G8991 – Goal X G8992 – Discharge No Functional Reporting Required No coding exists.

In summary, we maintain that claims-bas ed reporting should occur at the outset of therapy episode, on or before every 10 treatment days throughout the course of therapy, and at the time of discharge from therapy. Additionally, functional reporting is also required at the time the beneficiary’s condition changes significantly enough to clinically warrant a re-evaluation such that a HCPCS/CPT code for a re-evalu ation or a repeat ev aluation is billed. (7) Documentation We proposed to require that documentation of the information used for reporting under this system must be included in the beneficiar y’s medical record. As proposed, the therapist would need to track in the medi cal record the G-codes and the corresponding severity modifiers that were used to report the st atus of the functional limitations at the time reporting was required.274 Including G-codes and related modi fiers in the medical record crea tes an auditable record, assists in improving the quality of data CMS collects, a nd allows therapists to track assessment and functional information. In the proposed rule, we provided the example of a situation where the therapist selects the mobility functional lim itation of “walking and moving” as the primary functional limitation and determines that at therapy outset the benefi ciary has a 60 percent limitation and sets the goal to reduce the limitation to 5 percent. We noted that the therapist uses GXXX1-XH to report the current status of the functional impairment and GXXX2-XB to report the goal. Additionally, we said that the therapis t should note in the benefi ciary’s medical record that the functional limitation is “walking and mo ving” and document the G-codes and severity modifiers used to report this functional limitation on the clai m for therapy services. The following is a summary of comments we received concerning our documentation requirements.
Comment : Some commenters suggested that the proposal would impose significant additional documentation and claims reporting re quirements. Further, one commenter objected to the requirement to include information in the medical record on the G-codes and modifiers used for billing as it would be highly unusual and time intensive to do so. Another commenter supported our proposal, agreeing that documentation of the information used for reporting under this system must be included in the beneficiary’s medical record. Response : We disagree with the commenters’ st atements that the required documentation is overly burdensome. In fact, by maintaining the G-code descript or and related modifier in the medical record, therapists may find it easier to link treatment and reporting. Additionally, to enforce the reporting requirements on the clai ms, documentation in the medical record is required. In cases where the therapist uses othe r information in addition to certain measurement tools in order to assess functional impairment, he or she would also want to document the relevant information used to determine the overa ll percentage of functional limitation to select275 the severity modifier. In instances where it beco mes necessary for a different therapist to furnish the therapy services, the substitu te therapist can look in the bene ficiary’s medical record to note previous G-codes and related modifiers report ed. We are finalizing the proposed requirement that the G-codes and related modifiers must be doc umented in the beneficiary’s medical record. (8) Claims Requirements In the proposed rule, we noted that except for the addition of the proposed G-codes and the associated modifiers, nothi ng in this proposal w ould modify other existing requirements for submission of therapy claims. We noted in th e proposed rule that, in addition to the new Gcodes and modifiers used for the claims-based data collection system, the therapy modifiers – GO, GP, and GN, would still be required on clai ms to indicate that the therapy services are furnished under an OT, PT, or SLP plan of care, respectively; and, theref ore, we are designating these nonpayable G-codes as “always therapy.” We noted in the proposed rule that institutional claims for therapy services would require that a charge be included on th e service line for each one of these G-codes used in the required function al reporting. We also noted that this charge would not be used for payment purposes and woul d not affect processing. Further, we noted claims for professional services do not require th at a charge be included for these nonpayable Gcodes, but that reporting a charge for the nonpayable G-code s would not affect claims processing. To illustrate this policy, for each non payable G-code on the claim, that line of service would also need to cont ain one of the severity modifi ers , the corresponding GO, GP, or GN therapy modifier to indicate the respective OT , PT, or SLP therapy discipline and related POC; and the date of service it references. For each line on the institutional claim submitted by hospitals, SNFs, rehabilitation agencies, CORF s and HHAs, a charge of one penny, $0.01, can be added. For each line on the professional clai m submitted by private practice therapists and physician/NPPs, a charge of $0.00 can be added. We believe that many therapists submitting professional claims are already submitting nonpaya ble G-code quality measures under the PQRS276 and will be familiar with the parameters of nonpaya ble G-codes on claims for Medicare services. Finally, we noted that Medicare does not process claims that do not include a billable service. As a result, reporting under this claims -based data collection system would need to be included on the same claim as a furnis hed service that Medicare covers. We did not receive any commen ts specifically on the claims requirements so we are finalizing these as proposed. (9) Implementation Date In accordance with section 3005( g) of the MCTRJCA, we proposed to implement these data reporting requirements on January 1, 2013. We recognized that with electronic health records and electronic claims su bmission, therapists might encount er difficulty in including this new data on claims. To accommodate those that may experience operational or other difficulties with moving to this new reporting system and to assure smooth transition, we proposed a testing period from January 1, 2013 until July 1, 2013. We noted that we would expect that all those billing for outpatient therapy services would ta ke advantage of this testing period and would begin attempting to report the new G-codes a nd modifiers as close to January 1, 2013, as possible, in preparation for required reporti ng beginning on July 1, 2013. Taking advantage of this testing period would help to minimize poten tial problems after July 1, 2013, when claims without the appropriate G-codes and modifiers w ould be returned unpaid. The following is a summary of comments we received concerning our implementation of the new system on January 1, 2013 with en forcement beginning after July 1, 2013.
Comment : Given the statutory deadline, most commenters acknowledged that the new program needed to be implemented on Ja nuary 1, 2013. Many commenters supported the proposed testing period. They i ndicated that a testing period wa s needed to train therapists, change documentation practices, modify electr onic health records systems, educate billing contractors, and adjust billing systems. Howeve r, numerous commenters expressed concern that277

6 months is an insufficient and unrealistic amount of time to transition to the new data reporting requirements. Commenters requested that we recognize the significant tim e and financial burden of the new reporting requirement and that we allevi ate these concerns with delayed enforcement. Commenters requested a longer period to make software adjustments and educate therapists on the new reporting and frequency of documentation requirements. Further, commenters believed that we, in the limited time period, did not recogn ize the potential capital changes that would be necessary or allow for the typical process fo r acquiring funds. Commen ters proposed various alternatives, which included ex tending the testing pe riod to 9 or 12 months. A few suggested that we delay implementation of the mandate until the completion of the DOTPA study. As an alternative to nationwide data reporting, a few commenters suggest ed we consider testing the requirement under a pilot program in a small sa mple of the country, allowing us to analyze preliminary data and draw conclusions regard ing the effectiveness ofreporting through nonpayable G-codes and modifiers before it is implemented nationwide. Response : We are required by law to implement th e claims-based data collection strategy on January 1, 2013. Our contractors and systems will be able to accept and process claims for therapy services with functional in formation at this time. We recognize that therapists may need time to adjust their claims processing to accommodate these additional codes but, we believe the necessary changes can be accomplished well within th e 8 months between the time this final rule with comment period is issued and the end of the testing period. We do not believe a small pilot as suggested by some commenters would meet th e statutory requirement to implement as of January 1, 2013 a claims-based data collection strategy to assist in reforming outpatient therapy services. Nor would it meet our n eeds to gather data to assist in developing potential alternative payment systems for therapy services. We are finalizing an implementation date of January 1, 2013 with a 6-month testing period su ch that claims that do not co mply with the data reporting requirements will be returned beginning July 1, 2013.278 (10) Compliance Required as a Condition for Payment and Regulatory Changes To implement the claims-based data co llection system requi red by MCTRJCA and described above, we proposed to amend the regulations establishing the conditions for payment governing outpatient and CORF PT, OT, and SLP se rvices to add a requirement that the claims include information on beneficiar y functional limitations. In a ddition, we proposed to amend the POC requirements set forth in the regulations for outpatient therapy services and CORFs to require that the therapy goals, which must be included in the POC, are consistent with the beneficiary’s functional limitations and goals reported on claims for services. Specifically, we proposed to amend the regulations for outpatient OT, PT, and SLP (§410.59, §410.60, and §410.62, respectively) by adding a ne w paragraph (a)(4) to require that claims submitted for services furnished c ontain the required info rmation on beneficiary functional limitations. We also proposed to amend the POC require ments set forth at §410.61( c) to require that the therapy goals, which must be included in the treatment plan, must be consistent with those reported on claims for services. This requireme nt is in addition to those already existing conditions for the POC. To achieve consistency in the provision of PT, OT, and SLP services across therapy benefits, we proposed to ame nd §410.105 to include the same requirements for these services furnished in CORFs. These pr oposed revisions would require th at the goals specified in the treatment plan be consistent with the benefici ary functional limitations and goals reported on claims for services and that claims submitted for services furnished contain specified information on beneficiary functional limitations, respectively. The requirements do not apply to respiratory therapy services. We did not receive any comments on the pr oposed regulatory changes and are finalizing the changes as proposed.279 (11) Consulting with Relevant Stakeholders Section 3005(g) of the MCTRJCA requires us to consult with re levant stakeholders as we propose and implement this reporting system. In the CY 2013 PFS proposed rule, we indicated that we are meeting this requirement through the publication of this propo sal and specifically by soliciting public comment on the va rious aspects of our proposal. In addition, we noted that we would meet with key stakeholders and discuss this issue in Open Door Forums over the course of the summer. During the CY 2013 proposed rule comment period, we met with the various therapy professional associations and provider groups in order to solicit their comments on the various aspects of this proposal. At the CMS Physicia ns, Nurses & Allied Health Professionals Open Door Forum on July 17, 2012, we discussed the provi sions of the proposed rule, including these requirements. We also discussed this proposed rule at the CMS Hospital & Hospital Quality Open Door Forum on July 18, 2012. In developing the final rule, we took into consideration many of the critical issues that were raised by the various stakeholders in these meetings and Forums. Accordingly, we believe we have met our obligation to consult with relevant stakeholders in proposing and implementing the required claims-based data collection strategy, and in developing our final polic ies, we have taken into cons ideration the various needs of stakeholders affected by this effort.

H. Primary Care and Care Coordination In recent years, we have recognized prim ary care and care coordi nation as critical components in achieving better care for individua ls, better health for individuals, and reduced expenditure growth. Accordingly, we have prio ritized the development and implementation of a series of initiatives designed to improve paym ent for, and encourage long-term investment in, primary care and care management services. Th ese initiatives include the following programs280

and demonstrations:

● The Medicare Shared Savings Program (d escribed in “Medicare Program; Medicare Shared Savings Program: Accountable Care Orga nizations; Final Rule” which appeared in the Federal Register on November 2, 2011 (76 FR 67802)). ++ The testing of the Pioneer ACO model, designed for experienced health care organizations (described on the Center for Medicare and Medicaid I nnovation’s (Innovation Center’s) website at innovations.cms.gov/initiati ves/ACO/Pioneer/index.html ). ++ The testing of the Advance Payment AC O model, designed to support organizations participating in the Medicare Shared Savings Program (described on the Innovation Center’s website at innovations.cms.gov/initiatives/A CO/Advance-Payment/index.html ).

● The Primary Care Incentive Payment (PCI P) Program (described on the CMS website

at www.cms.gov/Medicare/Medicare-Fee-for-ServicePayment/PhysicianFeeSched/Downloads/PCIP-2011-Payments.pdf ).

● The patient-centered medical home model in the Multi-payer Advanced Primary Care Practice (MAPCP) Demonstration de signed to test whether the quali ty and coordination of health care services are improved by making advanced primary care practices more broadly available (described on the CMS website at www.cms.gov/Medicare/DemonstrationProjects/DemoProjectsEvalRpts/downloads/mapcpdemo_Factsheet.pdf ).

● The Federally Qualified Health Center (FQHC) Advanced Primary Care Practice demonstration (described on the CMS website at www.cms.gov/Medicare/DemonstrationProjects/DemoProjectsEvalRpts/downloads/mapcpdemo_Factsheet.pdf and the Innovation Center’s website at innovations.cms.gov/ini tiatives/FQHCs/index.html ).

● The Comprehensive Primary Care (CPC ) initiative (described on the Innovation Center’s website at innovations.cms.gov/initiatives /Comprehensive-Primary-CareInitiative/index.html ). The CPC initiative is a multi-payer initiative fostering collaboration281 between public and private health care payers to strengthen primary care in certain markets across the country. In coordination with these initiatives, we also continue to explore other potential refinements to the PFS that would appropriately value primary care and care coordination within Medicare’s statutory st ructure for fee-for-service physician pa yment and quality reporting. We believe that improvements in payment for pr imary care and recognizing care coordination initiatives are particularly important as EH R technology diffuses and improves the ability of physicians and other providers of he alth care to work together to improve patient care. We view these potential refinements to the PFS as part of a broader strategy th at relies on input and information gathered from the initiatives desc ribed above, research and demonstrations from other public and private stakeholders, the work of all parties involve d in the potentially misvalued code initiative, and from the public at large. In the CY 2012 PFS proposed rule (76 FR 42793 through 42794), we initiated a discussion to gather information about how prim ary care services have evolved to focus on preventing and managing chronic conditions. We also proposed to review evaluation and management (E/M) services as potentially misv alued and suggested that the American Medical Association Relative (Value) Update Committee (AMA RUC) might consider changes in the practice of chronic conditions management a nd care coordination as key reason for undertaking this review. In the CY 2012 PFS final rule with comment period (76 FR 73062 through 73065), we did not finalize our proposal to review E/ M codes due to consensus from an overwhelming majority of commenters that a review of E/M services using our curr ent processes could not appropriately value the evolving pr actice of chronic care coordinati on at the time, and therefore, would not accomplish the agency’s goal of paying appropriately for primar y care services. We stated that we would continue to consider ongo ing research projects, demonstrations, and the numerous policy alternatives suggested by commenters. In addition, in the CY 2012 PFS282 proposed rule (76 FR 42917 through 42920), we initiat ed a public discussion regarding payments for post-discharge care management services . We sought broad publ ic comment on how to further improve care management for a benefici ary’s transition from the hospital to the community setting within the existing statutor y structure for physician payment and quality reporting. We specifically discus sed how post discharge care ma nagement services are coded and valued under the current E/M coding stru cture, and we requested public comment. The physician community responded that compre hensive care coordination services are not adequately represented in the de scriptions of, or payments for, office/outpatient E/M services. The American Medical Associat ion (AMA) and the American Academy of Family Physicians (AAFP) created workgroups to consider new opt ions for coding and payment for primary care services. The AAFP Task Force recommended th at CMS create new primary care E/M codes and pay separately for non-face-to-face E/M Curr ent Procedural Terminology (CPT) codes. (A summary of these recommendations is available at www.aafp.org/online/en/home/public ations/news/news-now/insideaafp/20120314cmsrecommendations.html .) The AMA workgroup, Ch ronic Care Coordination Workgroup (C3W), has and continues to develop codes to describe ca re transition and care coordination activities. (Several workgroup meeting minutes and other related items are available at www.ama-assn.org/ama/pub/physician-re sources/solutions-managing-yourpractice/coding-billing-insuranc e/medicare/care-coordination.page .) Since the publication of the proposed rule, the C3W has completed developmen t of two new transiti onal care management (TCM) codes. These new codes are:

● 99495 Transitional Care Management Services with the following required elements: ++ Communication (direct contact, telephone , electronic) with the patient and/or caregiver within 2 busine ss days of discharge. ++ Medical decision making of at least mode rate complexity during the service period.283
++ Face-to-face visit, within 14 calendar days of discharge.

● 99496 Transitional Care Management Services with the following required elements:

++ Communication (direct cont act, telephone, electronic) w ith the patient and/or caregiver within 2 busine ss days of discharge.

++ Medical decision making of high comp lexity during the service period.

++ Face-to-face visit, within 7 cal endar days of discharge. We discuss these codes in greater detail below. Under current PFS policy, care coordination is a component of E/M services which are generally reported using E/M CPT codes. The pre- and post-encounter non-face-to-face care management work is included in calculating the total work for the typical E/M services, and the total work for the typica l service is used to develop RVUs for the E/M services. In the CY 2012 PFS proposed rule, we highlighted some of the E/M services that incl ude substantial care coordination work. Specifically, we noted that th e vignettes that describe a typical service for mid-level office/outpatient services (CPT codes 99203 and 99213) include furnishing care coordination, communication, and other necessary car e management related to the office visit in the post-service work. We also highlighted vignettes that descri be a typical service for hospital discharge day management (CPT codes 99238 and 99239), which include furnishing care coordination, communication, and other necessary management related to the hospitalization in the post-service work. The payment for non-face-to-face care manageme nt services is bundled into the payment for face-to-face E/M visits. Moreover, Medicare doe s not pay for services that are furnished to parties other than the beneficiary and wh ich Medicare does not cover, for example, communication with caregivers. Accordingly, we do not pay separately for CPT codes for telephone calls, medical team conferences, prolo nged services without patient contact, or anticoagulation management services.284 However, the physician community continues to tell us that the care coordination included in many of the E/M services, such as o ffice visits, does not adequately describe the nonface-to-face care management work involved in primary care. Because the current E/M office/outpatient visit CPT codes were designed to support all offi ce visits and reflect an overall orientation toward episodic treatment, we agr ee that these E/M codes may not reflect all the services and resources required to furnish comp rehensive, coordinated care management for certain categories of beneficiaries such as those who are returning to a community setting following discharge from a hospital or SNF stay. As part of our multi-year strategy to recognize and support primary care and care management, we proposed in the CY 2013 PFS proposed rule (77 FR 44776-44780) to create a HCPCS G code to describe care management involving the transition of a beneficiary from care furnished by a treating physician during a hospital stay (inpatient, outpatient observation services, or ou tpatient partial hospita lization), SNF stay, or community mental health center (CMHC) partia l hospitalization program to care furnished by the beneficiary’s primary physician in the comm unity. We also solicited comment on how care furnished in these settings might be incorporated into the current fee-for-service structure of the
PFS. Specifically, this HCPCS G code would descri be all non-face-to-face services related to the TCM furnished by the community physician or qualified nonphysician practitioner within 30 calendar days following the date of discharge from an inpatient acute care hospital, psychiatric hospital, long-term care hospital, skilled nursing facility, and inpatient rehabilitation facility; hospital outpatient for observation services or partial hospitalization services; and a partial hospitalization program at a CMHC to community -based care. The post-discharge TCM service includes non-face-to-face care mana gement services furnished by clinical staff member(s) or office-based case manager(s) under the supervisi on of the community physician or qualified nonphysician practitioner. We based the concept of this proposal, in part, on our policy for care285 plan oversight services. We currently pay physic ians for the non-face-to-face care plan oversight services furnished for beneficiaries under care of home health agencies or hospices. These beneficiaries require complex and multidiscip linary care modalities that involve: regular physician development and/or revision of care plans, subsequent reports of patient status, review of laboratory and other studies, communication with other health professionals not employed in the same practice who are involved in the patient’ s care, integration of ne w information into the care plan, and/or adjustment of medical thera py. Physicians furnishing these services bill HCPCS codes G0181 or G0182 (See the Medicare be nefit manual, 100-02, Chapter 15, Section 30 for detailed description of these services.) For CY 2013, we proposed to create a new code to describe post-discharge TCM services. This service wa s proposed to include:

● Assuming responsibility for the beneficiary’s care without a gap. ++ Obtaining and reviewing the discharge summary. ++ Reviewing diagnostic tests and treatments. ++ Updating of the patient’s medical r ecord based on a discharge summary to incorporate changes in health conditions and on-going treatments relate d to the hospital or nursing home stay within 14 business days of the discharge.

● Establishing or adjusting a plan of care to reflect required and indicated elements, particularly in light of the servi ces furnished during the stay at the specified facility and to reflect result of communication with beneficiary. ++ An assessment of the patient’s health st atus, medical needs, functional status, pain control, and psychosocial n eeds following the discharge.

● Communication (direct contact, telephone, electronic) with the beneficiary and/or caregiver, including educa tion of patient and/or caregiver within 2 business days of discharge based on a review of the discharge summary and other available information such as diagnostic286 test results, including each of the following tasks: ++ An assessment of the patient’s or car egiver’s understandi ng of the medication regimen as well as education to reconcile the medication regimen differences between the preand post-hospital, CMHC, or SNF stay. ++ Education of the patient or caregiver regarding the on-going care plan and the potential complications that shou ld be anticipated and how they should be addressed if they arise. ++ Assessment of the need for and assistance in establishing or re -establishing necessary home and community based resources. ++ Addressing the patient’s medical a nd psychosocial issues, and medication reconciliation and management. When indicated for a specific patient, the post-discharge transitional care service was also proposed to include:

● Communication with other health care pr ofessionals who will (re)assume care of the beneficiary, education of patient, family, guardian, and/or caregiver.

● Assessment of the need for and assistance in coordinating follow up visits with health care providers and other necessary services in the community.

● Establishment or reestablishmen t of needed community resources.

● Assistance in scheduling any required follow-up with community providers and services. The proposed post-discharge transitional care HCPCS G code was described as follows: GXXX1 Post-discharge tran sitional care management with the following required elements:

● Communication (direct contact, telephone, el ectronic) with the patient or caregiver within 2 business days of discharge.287

● Medical decision making of moderate or high complexity during the service period.

● To be eligible to bill the service, physicians or quali fied nonphysician practitioners must have had a face-to-face E/M visit with the pa tient in the 30 days prior to the transition in care or within 14 business days fo llowing the transition in care. The post-discharge transitional care services HCPCS G code we proposed would be used by the community physician or qualified nonphysici an practitioner to re port the services furnished in the community to ensure the coor dination and continuity of care for patients discharged from a hospital (inpatient stay, outpatient observation, or outpatient partial hospitalization), SNF stay, or CMHC. The post-discharge transitional care service would parallel the discharge day management serv ice for the community physician or qualified nonphysician practitioner and complement the E/ M office/outpatient visit CPT codes. We proposed that the post-dis charge transitional care serv ice HCPCS G code would be used to report physician or qualifying nonphysicia n practitioner services for a patient whose medical and/or psychosocial problems requires m oderate or high complexity medical decisionmaking during transitions in care from hospital (i npatient stay, outpatient observation, and partial hospitalization), SNF stay, or CMHC settings to community-based care. The Evaluation and Management Guidelines define decision-making of moderate and high medical complexity. In general, moderate complexity medical deci sion-making includes multiple diagnoses or management options, moderate complexity and amount of data to be reviewed, a moderate amount and/or complexity of data to be re viewed; and a moderate risk of significant complications, morbidity, and/or mortality. High complexity decision-making includes an extensive number of diagnoses or management op tions, an extensive amo unt and/or complexity of data to be reviewed, and high risk of signi ficant complications, morbidity, and/or mortality (See Evaluation and Management Services Guide, Centers for Medicare & Medicaid Services, December 2010.) We proposed that the post-di scharge transitional care HCPCS code (GXXX1)288 would be payable only once in the 30 days followi ng a discharge, per patient per discharge, to a single community physician or qualified nonphysi cian practitioner (o r group practice) who assumes responsibility for the patient’s post-di scharge TCM services. The service would be billable only at 30 days post discharge or ther eafter. The post-discharge TCM service would be distinct from services furnished by the discharging physician or qualified nonphysician practitioner reporting CPT codes 99238 (Hospital discharge day management, 30 minutes or less); 99239 (Hospital discharge day management , more than 30 minutes); 99217 (Observation care discharge day management); or Observatio n or Inpatient Care services, CPT codes 99234 - 99236; as appropriate. We proposed to pay only one claim for th e post-discharge transitional care GXXX1 billed per beneficiary at the conclusion of th e 30 day post-discharge period Given the elements of the service and the short window of time following a discharge during which a physician or qualifying nonphysician practitione r will need to perform seve ral tasks on behalf of a beneficiary, we stated our beli ef that it would be unlikely th at two or more physicians or practitioners would have had a face-to-face E/M contact with the beneficiary in the specified window of 30 days prior or14 days post disc harge and have furnished the proposed postdischarge TCM services listed above . Therefore, we did not believe it necessary to take further steps to identify a beneficiary’s community phys ician or qualified nonphysi cian practitioner who furnished the post-discharge TCM services. We proposed to pay only one claim for the postdischarge transitional care GXXX1 billed per beneficiary at the conclusion of the 30 day postdischarge period. Post-discharge TCM services relating to any subsequent discharges for a beneficiary in the same 30-day period would be included in the single pa yment. Practitioners billing this post-discharge transitional care code accept responsibility for managing and coordinating the beneficiary’s care over the first 30 days after discharge.
Comment : We received many comments on the pr oposed new code. The vast majority289 supported the concept in whole or in part. Only a handful of comments were generally opposed to the proposal to recognize and pay for TCM services. On e commenter, while acknowledging that our proposal was “well in tentioned,” expressed concern a bout adopting such an important proposal without explicit statutory direction. In particular, the commenter recommended that we should be more judicious in using the PFS rule making process to adopt far-reaching new policies requiring sizable BN adjustments. The commente r suggested that, if the proposed policies had been mandated by the Congress, the BN adjustment would presumably not be required. Another commenter suggested that the proposed new c ode was duplicative, because pre- and postencounter non-face-to-face care management work is included in the total work for the typical E/M services, and the total work for subsequent post-operative visits that accompany surgical procedures. Response : We thank the commenters who wrote in support of this proposal. For the reasons that we stated in the proposed rule, we do not believ e that all the pre- and postencounter non-face-to-face care management work that typically occurs when a beneficiary is discharged from a hospital, SNF or CMHC stay is included in the total work for the typical E/M services. This is because the E/M codes represent the typical out patient visit and do not capture or reflect the significant care coordination that needs to occur when a beneficiary transitions from institutional to community-based care. (77 FR 44776) Therefore, we continue to believe that separate payment for TCM services does not duplicate payment for typical E/M services. We also believe that adoption of new codes such as our proposed TCM code is consistent with our statutory directive to mainta in the physician fee schedule by recognizing changes in practice patterns and by adjusting codes, relative values, and payment accordingly. We have routinely added new codes created by AMA CPT to the fee schedule. As we indi cated in the proposed rule, our proposal was, in part, a response to work by the AMAs C3W to develop new codes for TCM services. Below we discuss the AMA’s recommendation that we adopt the TCM codes290 developed by that workgroup in place of our proposed TCM G-code.
Comment : Most comments were generally supp ortive of the proposal to recognize and pay for TCM services. A few commenters mere ly expressed general support for the proposal. However, the great majority of these genera lly positive comments also recommended adopting the proposed TCM G code with revisions to th e code description, or adopting the AMA’s new CPT TCM codes in place of our proposed TCM G-code. Response : We appreciate the widespread support for our initiative to recognize and pay for TCM services. As we discuss below, we ar e proceeding with our proposal in a modified form, adopting some of the commenters’ sp ecific recommendations for revision. Most importantly, we are accepting the recommendati on of many commenters that we adopt the AMA’s CPT TCM codes in place of our proposed TCM G-code. As discussed below, we will therefore pay for new CPT TCM codes 99495 and 99496 with some small modifications to the code descriptions developed by the AMA’s C3 W. The new TCM codes developed by the AMA
C3W are:

● 99495 Transitional Care Management Services with the following required elements: ++ Communication (direct contact, telephone , electronic) with the patient and/or caregiver within 2 busine ss days of discharge. ++ Medical decision making of at least mode rate complexity during the service period. ++ Face-to-face visit, within 14 calendar days of discharge.

● 99496 Transitional Care Management Services with the following required elements:

++ Communication (direct cont act, telephone, electronic) w ith the patient and/or caregiver within 2 busine ss days of discharge.

++ Medical decision making of high comp lexity during the service period.

++ Face-to-face visit, within 7 cal endar days of discharge. We discuss these codes in greater detail and re spond to these specific recommendations below.291

Comment : Many commenters, including the AM A and other specialty societies, expressed appreciation for our initiative to pr opose a new G-code and language to describe TCM, but urged us instead to implement the new CPT TCM codes. Commenters emphasized that these codes represented th e consensus of the physician co mmunity as represented by the AMA’s C3W. Commenters also emphasized that the CPT TCM c odes are very similar to our proposal, with a few key differen ces. We summarize the key di fferences between our proposed TCM G-code and the CPT TCM codes in Table 26. TABLE 26: Key Differences between Propos ed Transitional Care Management (TCM) Gcode and the CPT codes CMS Proposed TCM G-code CPT TCM Codes Code(s) GXXX1—Post-discharge transitional care management (medical decision making of moderate to high complexity) 99490X—Transitional care management services (medical decision making of moderate complexity), and 99491X—Transitional care management services (decision making of high complexity) Face-to-face visit Separate ly billed face-to-face E/M visit within 30 days prior to the hospital discharge or within the first 14 days of the 30-day period of TCM services Face-to-face visit within 14 calendar days of discharge (99490X), or within 7 calendar days (99491X). The first face-to-face visit is part of the TCM service and not reported separately. E/Mservices after the first face-toface visit may be reported separately. Relationship with patient The patient may be new to the physician’s practice (provided the face-to-face visit requirements above are met). The reporting physician or NPP must have an established relationship with the patient. Established patient means a visit in the past 3 years. Discharge management The physician or NPP who bills for discharge management services during the time period covered by TCM services may not also bill for GXXX1. A physician or NPP may report both the discharge code and appropriate TCM code.

Global services The physician who reports a service with a global period The physician who reports a service with a global period292
CMS Proposed TCM G-code CPT TCM Codes of 010 or 090 days may not also report the TCM service. of 010 or 090 days may not also report the TCM service. However, the AMA recommends that specialties work on a CPT proposal for a new code to describe extensive post-discharge TCM services.

A few commenters from the medical community did not specifically recommend adopting the CPT TCM codes. For example, one major me dical society supported our proposal on the grounds, among other considerations, that it was c onsistent with the “general direction of organized medicine, as evidenced by the fact th at the AMA's CPT Editorial Panel has created two new codes for transitional care management.” This commenter then expressed support for several of the several elements in our proposed G code which differ from the CPT TCM codes, such as our “proposal to keep the require d post-discharge face-to-face E/M separately reportable.” (We discuss th is issue in furt her detail later in this section.) Response : We agree with those commenters who recommended that we should acknowledge the physician community’s work on primary care by adopting the CPT TCM codes in place of our proposed G-code. With regard to the differences noted above, we agree with the AMA’s CPT construction that uses two separa te codes to distinguish moderate and high complexity services in place of our single propos ed G-code, which allowed for reporting services of either moderate or high complexity. We discuss the issues connected with the other differences between our proposed TCM G-code a nd the AMA’s CPT TCM codes in responses to more specific comments of the AMA and others below. We explicitly constructed this proposal as a payment for non-face-to-face post-discharge TCM services separate from payment for E/M or ot her medical visits. However, we believe that it is important to ensure that the community physician or qua lified nonphysician practitioner293 furnishing post-discharge TCM services either al ready have or establish, soon after discharge, a relationship with the beneficiary. As such, we proposed that the community physician or qualified nonphysician practitione r reporting post-discharge TCM GXXX1 should already have a relationship with the beneficiary, or establish one soon after discharge, prior to furnishing TCM and billing this code. Therefore, we specifi cally proposed that the community physician or qualified nonphysician practitioner reporting a TCM G-code must have billed an E/M visit for that beneficiary within 30 days prior to the hospital discharge (the start of post-discharge TCM period), or must conduct an E/M office/outpatient visi t (99201 to 99215) within the first 14 days of the 30-day post-discharge peri od of TCM services. In either case, the E/M visit would be separately billed under our G-code proposal. Wh ile we proposed that the post-discharge TCM code would not include a face-to-face visit, and that physicians or qualified nonphysician practitioners would bill and be pa id for this care management serv ice separately from a medical visit, we sought comments about whether we shou ld require a face-to-face visit when billing for the post-discharge TCM service: that is, whet her we should bundle a required visit into the reporting and payment for the TCM codes. We we re also concerned abou t whether beneficiaries would understand their coinsurance liability for th e post-discharge transitional care service when they did not visit the physici an’s or qualified nonphysicia n practitioner’s office.
Comment : The AMA and many other commenters recommended that we should require a face-to-face visit within 7 to 14 days after discharge when b illing for the post-discharge TCM service. Under the CPT TCM codes, the first f ace-to-face visit is part of the TCM service and not reported separately. Add itional E/M services required fo r managing the beneficiary’s clinical issues in addition to the required face -to-face visit may be reported separately. These commenters emphasized that requiring a face-to-face vi sit within 7 to 14 days of discharge will provide for a more successful transition from facility to community. Other commenters maintained that we should retain the requirement for a separately billable face-to-face E/M either294 within 30 days before or 14 days after discharge. These comm enters emphasized that such a requirement acknowledges that an established rela tionship with the patient is needed to bill the new code, and the level of E/M service will not be the same for every patient. A few commenters specifically recommended that it was not necessary to adopt any such requirement for a face-to-face visit (whether separately billable or not) in the context of a service that is essentially non-face-to-face. Some emphasized that it could be inefficient to require a visit that may not always be clinically necessary, and that the clinical decision a bout whether a visit is necessary should be left to the physician or qualified nonphysician practitioner. Other commenters emphasized that an office visit coul d be impractical in cases where patients may have limited mobility or otherwise have difficulty travelling to a physician office. Some of these commenters urged that we not adopt such a requirement, wh ile others recommended that we expand the list of acceptable face-to -face visits to include other out patient visit codes, such as home visits (99341-99350) and domic iliary/rest home visits (99324- 99337). Still others stated that the window in which the post discharge vis it must occur should be extended to 30 days postdischarge, not 14 days. Response : The primary driver in creating these new CPT TCM codes has been to improve care coordination and to pr ovide better incentives to ensure that these patients are seen in a physician’s office, rather th an be at risk for readmission. Therefore, we agree that care coordination beginning immediatel y upon discharge and the face-t o-face visit within 7 or 14 days of discharge (as appropriate) will provide for a more successful transition from a facility to the community. However, as we indicated in th e proposed rule, our adoption of codes for TCM services is part of the broader HHS and CMS multi-year strategy to recognize and support primary care and care management, and we are committed to considering new options and developing future proposals for payment of prim ary care services under th e MPFS. Therefore, we consider the requirement for a face-to-face vi sit in association with the non-face-to-face tasks295 of TCM to be a short-term, transitional strategy while we continue to explore our interest in further improvements to advanced primary care payment. We also share the commenters’ concerns about beneficiaries who may have limited mobility or otherwise have difficulty travelli ng to a physician office in the period following a discharge. We note that the final CPT TC M codes, 99495 and 99496, which we are adopting in this final rule with comment period, requires a face-to-face visit, but does not specify the location/setting for that portion of the service. The AMA RUC states in its recommendation that, “each code includes a timely face-to -face visit which typically occurs in the office, but can also occur at home or other location where the pati ent resides.” Finally, we agree with those commenters who stated that bene ficiaries would understand their co insurance liability better if the TCM services included a required E/M visit as part of the service. We also sought comments regarding whether we should incorporate such a required visit on the same day into the payment for the proposed code. We considered several reasons for requiring a face-to-face visit on the same day as th e date of discharge. We wondered whether, with a face-to-face visit immediatel y after discharge, the plan of care would be more accurate given that the patient’s medical or psychosocia l condition may have changed from the time the practitioner last met with the patient and the pr actitioner could better develop a plan of care through an in-person visit and discussion. On th e other hand, we contempl ated several scenarios where it is not possible for a beneficiary to get to the physician’ s or qualified nonphysician practitioner’s office and welcomed comment on whether an exception process would be appropriate if we were to fina lize a same day face-to-face visit as a requirement for billing the post-discharge TCM code.
Comment : Commenters were almost uniformly o pposed to a requirement for a same day visit. The commenters believed that a same da y visit is unrealistic a nd should not be required because hospital discharge records are not alwa ys immediately availabl e to the physician who296 would be assuming responsibility for transitional care. Some co mmenters, including several who favor a face-to-face requirement other than a same day requirement, also favored an exception for beneficiaries too feeble to travel to an office. Other commenters maintained that a requirement for a face-to-face encounter with an exception process could prove confusing and administratively challenging as it would requ ire communication of ex ceptions criteria and audit/appeals processes. Response : In conjunction with adopting the AMA’s recommendation to require a faceto-face visit within 7 or 14 days of discharge for reporting the CPT TCM codes, we have also decided not to proceed with a requirement for a same day face-to-face visit. We agree with commenters who stated that such a requirement would be unrealistic in many situations, and would require the adoption of an exceptions process that could, unto itself, prove administratively difficult and confusing. At the same time, we emphasize that we believe physicians should seek to make an assessment a nd conduct the face-to-face visit as quickly as medically necessary after discharge in or der to address patie nt care needs.
Comment : As we noted above, we proposed to require communication (direct contact, telephone, electronic) with the patient or careg iver within 2 business days of discharge. Some commenters stated that the specific requirement for the physician to communicate with the patient within 2 business days of discharge to be gin the coordination of care is unrealistic. Some contended that hospital discharge records are not always availabl e that quickly. Several other commenters expressed concern about the references to "business days" in this requirement. (Other requirements, for length of TCM service and the timing of the required E/M visit are established in terms of calenda r days for purposes of the TCM codes.) The commenters noted that, traditionally, business days are Monday th rough Friday, except for holidays. However, many primary care practices are also open on week ends, making those "business days" for those practices. Most importantly, be neficiaries’ need for medical care and care coordination is not297 limited to "business days," nor are their discha rges. Thus, the commenters recommended that CMS change "business days" to " calendar days" in this context, which, they asserted, would be consistent with CMS's proposal to define the co de as a 30 calendar day service. The AMA CPT TCM codes incorporate a requirement for an interac tive contact with the patient or caregiver, as appropriate, within 2 business days of discharge. This contact may be direct (face-to-face), telephonic, or by electronic means. The AMA CP T TCM codes also specify that, for purposes of this requirement, business days are Monday thr ough Friday, except holidays , without respect to normal practice hours or date of notif ication of discharge. If two or more separate attempts are made in a timely manner, but are unsuccessful a nd other TCM criteria are met, the service may be reported. We emphasize, however, that we exp ect attempts to communicate to continue until they are successful. Response : Our proposed TCM G-code contained a requirement for communication with the patient or caretaker within 2 business days of discharge. We also agree with the AMA’s assessment concerning the importance of such a re quirement to meeting the goals of successful TCM. We also agree with the AMA’s provision to allow for billing of the TCM service if two or more separate, unsuccessful attempts at commun ication are made within a timely fashion. We believe that this provision shoul d substantially reduce the concerns of some commenters about the tight timeline for making this initial contact. We also believe that concerns about the availability of hospital discharge records shoul d decline dramatically as both hospitals and physicians respond to the current incentive paym ents (and the payment reductions beginning in 2015) to encourage adoption of el ectronic health records systems. We cannot agree with those commenters who suggested that we should substitute “calendar days ” for “business days” in this requirement. We do not believe that the timeframe for this requirement needs to be expressed in calendar days to be consistent with the 30 cal endar day timeframe for the service. More importantly, establishing a timeframe of 2 calenda r days for this initial contact would severely298 disadvantage those practices which do not ha ve regular business hour s on the weekends.
Comment : In our proposed G-code, we required that physicians or qualified nonphysician practitioners must have had a face-to-face E/M vis it with the beneficiary in the 30 days prior to the transition in care or within 14 business days following the tran sition in care. However, we allowed that, if the physician or qualified nonphys ician practitioner met th is requirement, the patient could otherwise be new to the practi ce. The AMA recommended that the physician reporting the CPT TCM codes must have an establis hed relationship with th e patient, as required for the those codes, rather than allowing physicia ns to bill for TCM services furnished to patients who are new to their practices. Under CPT TCM definitions, an established relationship with a patient exists when a physician has billed a visit with the patient within the last three years. Many commenters maintained that a vi sit within 30 days prior to the discharge was largely irrelevant to the actua l provision of TCM services. Ot her commenters maintained that defining a pre-existing relationship as a visit within 30 days prio r to the discharge is far too restrictive. A patient with established dis ease may only be seen by a physician every 3 to 6 months. We should therefore allo w an E/M service to be furnished any time in the 12 months prior to the discharge to be considered evidence of an established relationship. Response : We agree with commenters that a visi t within 30 days before the hospital discharge might be too restrictiv e for purposes of establishing an existing relationship with a patient. We are therefore accepting the AM A’s recommendation not to include such a requirement in the CPT TCM codes and note that the CPT TCM codes also do not require a visit within 30 days before discharge. Rather, as the AMA has recommended, we will include a requirement for a face-to-face visit with the benefi ciary within 14 days (in the case of CPT code 99495) or 7 days (in the case of CPT code 99495. This required visit is bundled into the payment for the codes and is not separately paya ble. We do not entirely agree with the AMA’s recommendation that the physician must have an established relationship prior to the discharge299 with the patient to report the CPT TCM codes. We are concerned that such a requirement would make it impossible for an especially vulnerable group of patients, specif ically, those who do not have an established a relations hip with a primary care or othe r community physician, to receive the benefit of post-discharge TCM services. Th ese patients may well be among those who would benefit most from these services, particularly because receiving TCM serv ices could provide the opportunity for them to establis h a continuing relationship with a physician who is able to assume overall management of their care. Theref ore, , in conjunction with our adoption of the CPT TCM codes, we will develop additional Me dicare-specific guidance for the use of these codes that modifies this element of the CPT TCM prefatory instructions, to allow a physician to bill these codes for new patients (provided that the physician meets visit requirement and all other requirements for the CPT TCM codes). It is important to note, however, that the payment amount for the CPT TCM codes will be the same whether the codes are billed under Medicare for treating new or established patients under the TCM codes. For Medicare purposes we are modifying the prefatory instructions for the CP T TCM codes because we wish to encourage the provision of TCM services to thos e beneficiaries who can benefit fr om the services – whether the beneficiary is a new or established patient. However, we believe that the typical case will involve provision of TCM services to an estab lished patient, and relativ e values for codes are established on the basis of the t ypical case. Physicians may choose to bill other appropriate codes (for example, new patient E/M codes) th at better describe the services furnished.
Comment : We proposed that a physician or qualified nonphysician practitioner who bills for discharge day management during the time period covered by the TCM services code may not also bill for HCPCS code GXXX1. The CPT discharge day management codes are 99217, 99234-99236, 99238-99239, 99281-99285, or 99315-99316. The AMA/RUC and many other commenters recommended that a physician repor ting the discharge management should also be able to report the new TCM service. Th e AMA/RUC and other commenters noted an AMA data300 analysis that nearly 25 percent of those visits re ported within 14 days of discharge were from the physician who also furnished the discharge servi ces. The commenters emphasized that discharge management services reflect the work done at th e time of discharge. Th e TCM service describes the work following discharge. Therefore, th e commenters contended that there should be minimal or no overlap in the actual work perf ormed in providing these two services. Other commenters emphasized that the physician or group practice billing for discharge day management could also be the physician or group pr actice regularly respon sible for the patient’s primary care and would therefore be the appropria te physician to take responsibility for the patient’s transition to the community. Response : We accept the AMA/RUC’s recommendation (as supported by a number of commenters) to allow a physician to report bo th the discharge management code and a CPT TCM code. We agree with those commenters who em phasized that the physician billing discharge day management could also be the physician who is regularly responsible for the beneficiary’s primary care (this may be especially the case in rural communities), and who would therefore be the appropriate physician to take responsibility for the patient’s transition to the community. However, we continue to be concerned that th ere could be some overlap in the actual work involved in providing these two se rvices and, that payment to one physician for both of these services might be excessive as a result. Therefor e, we will monitor claims data to ascertain the extent to which the same physician bills fo r both the discharge day management and TCM services and analyze whether it may be appropr iate to develop a payment adjustment that recognizes overlap in resources in the future. In addition, we note that the CPT TCM code prefatory language provides that the TCM service period “commences upon the date of discha rge and continues for the next 29 days.” Subsequent CPT TCM language indicates that the first visi t must occur within 7 or 14 calendar days of the date of discharge depending on the level of decision-making. We are unclear as to301

whether the CPT TCM prefatory language intends to allow th e first visit to occur on the same date as discharge. We note that there is a distinction be tween the discharge day management and TCM services, and we wish to avoid any implica tion that the E/M servic es furnished on the day of discharge as part of the di scharge management service could be considered to meet the requirement for the TCM service that the physic ian or nonphysician practitioner must conduct an E/M service within 7 or 14 days of discharge. Therefore, we will specify that the E/M service required for the CPT TCM codes cannot be furnished by the same physician or nonphysician practitioner on the same day as the discharge management service.
Comment : A number of commenters suggested that payment for the E/M hospital discharge management codes (CPT 99238 or 99239) is inadequate to re flect the discharging duties of the physician. While most of these commenters supported enhanced payment for community physicians to furnish care coordination services on the receiving end, they stated that a corresponding increase in paymen t to those physicians who are discharging patients is also warranted. Response: We continue to believe that the curr ent hospital discharge management codes (CPT codes 99238 and 99239) and nursing facility discharge services (CPT codes 99315 and 99316) adequately capture the care coordination services required to discharge a beneficiary from hospital or skilled nursing facility care. The work relative valu es for those discharge management services include a number of pre-, po st-, and intra-care coor dination activities. For example, the hospital discharge management code s include the following pre-, intra-, and postservice activities relating to care coordination: Pre-service care coordination activities include:

● Communicate with other professionals and with patient or patient’s family. Intra-service care coordination activities include:

● Discuss aftercare treatment with the patient, family and other health care professionals;302

● Provide care coordination for the transiti on including instructions for aftercare to caregivers;

● Order/arrange for post discharge follow-up professional services and testing; and

● Inform the primary care or referring physic ian or qualified nonphysic ian practitioner of discharge plans. Post-service care coordination activities include:

● Provide necessary care coordination, telephonic or electronic communication assistance, and other necessary management related to this hospitalization; and

● Revise treatment plan(s) and communicate with patient and/or caregiver, as necessary. The hospital and nursing facility discharge mana gement codes also include a number of other pre-, intra and post-service activities. We certainly recognize that th e services of physicians and other practitioners providing discharge management services ar e crucial to the overall success of TCM services. These codes have been valued by the AMA/RUC in the past, and these valuations have been reviewed and accepted by us. At this time, we are not aware of any substantive evidence that these codes are systematically undervalued.
Comment : We proposed that a physician or qualified nonphysician practitioner who bills for emergency department visits (99281-99285), ho me health care plan oversight services (HCPCS code G0181), or hospice care plan overs ight services (HCPCS code G0182) during the time period covered by the TCM services code may not also bill for HCPCS code GXXX1. We indicated that we believed these codes describe care management services for which Medicare makes separate payment and should not be bi lled in conjunction with GXXX1, which is a comprehensive post-discharge TCM service. The AMA noted that for the proposed TCM Gcode we would not allow TCM services to be reported with emergency department visits, home health care oversight (G0181), hospice care plan oversight (G0182). The AMA CPT TCM codes303 allow for reporting of emergency department visits . The AMA also indicated that a physician or other qualified health care profe ssional who reports a TCM code may not report the CPT codes for care plan oversight serv ices (99339, 99340, 99374-99380). At the same time, the CPT TCM codes also specify that many other codes may no t be reported with TCM (for example, non-faceto-face services such as telephone calls). Response : In conjunction with adopting the AMA CPT TCM, we accept the recommendation to allow reporting of emergency de partment visits when also billing the CPT TCM codes. We also agree with the recomm endation not to allow re porting of care plan oversight services when also billing the CPT TCM codes. We had proposed to prohibit billing of the G-codes that we employ for home health care oversight (G0181), and hospice care plan oversight (G0182) with our proposed TCM G-code, on the grounds that such care management services duplicate the services provide in TCM. We are including these G-codes in the list of codes for such services that are precluded from billing with the CPT TCM codes, because we continue to believe that they are duplicative of the CPT care plan management aspects of the CPT TCM codes. We will also accept the AMA recommendation specifying many additional codes that may not be reported with CPT TCM codes (for example, non-face-to-face services such as telephone calls), as specified in the descripti ons of CPT TCM codes 99495 or 99496 below. We are accepting these recommendati ons because they similarly avoid duplicate payment for the same services. Further, we proposed that a physician or qualified nonphysician practitioner billing for a procedure with a 10- or 90-day global period w ould not also be permitted to bill HCPCS code GXXX1 in conjunction with that procedure beca use any follow-up care management would be included in the post-operative po rtion of the global period.
Comment : Many commenters expressed concerns with prohibiting physicians who bill services with a global period from billing the TC M code as well. One commenter stated that304 “permitting a surgeon to receive payment under these circumstances would not result in duplicate payment for the same service... [I]f follow-up care management included in the postoperative portion of a global pe riod can be reimbursed separately from the proposed transitional care management code when performed by tw o different physicians, they should remain separately reimbursable when these functions are all performed by the same physician.” One commenter specifically agreed wi th our proposal to prohibit th e billing of TCM by a physician providing the original care with in a 010 or 090 day global period code. The AMA CPT TCM codes do not allow physicians billing services with global periods of 010 and 090 days to bill for TCM services. However, the AMA RUC recomm ends that specialties work with the CPT Editorial Panel to develop a new code for those cases in which comprehensive TCM services are furnished along with the services already bundled into the global codes. However, the AMA RUC also indicates that it w ould not be typical for a surge on to furnish TCM services. Response : We agree with the commenters th at the physician who reports a global procedure should not be permitted to also report the TCM service, and we are adopting that policy in this final rule. The AMA RUC specifically states in its comment letter that it would not be typical for surgeons billing gl obal procedures to also provide TC M services. Our goal is that the physician billing for TCM serv ices should have an ongoing relati onship with the beneficiary. We do not believe surgeons typically would be in a position to coordi nate all aspects of a patient’s care, because their rela tionship with a beneficiary freque ntly ends after the end of the global period (unless or until addi tional surgery is required). We proposed that the TCM code would be payable only once in the 30 days following a discharge, per patient per discharge, to a si ngle community physician or qualified nonphysician practitioner (or group practice) w ho assumes responsibility for th e patient’s post-discharge TCM . We expressed our belief that, given the elemen ts of the TCM service and the short time period during which they must be furnished, it would be unlikely that two or more physicians would305 meet the requirements for billing the TCM code.
Comment : Many commenters requested clarifica tion concerning whether the TCM codes could be billed again if another hospital admissi on and discharge occur within the initial 30 day period following a discharge. The commenters r ecommended that we allow the clock to start over with each admission, that is, allow for pa yment of TCM even when readmission occurs within the original 30 day peri od after a discharge. A few commenters recommended that CMS develop a mechanism to monitor readmissions for patients receiving TCM services to determine if this effort positively impacts beneficiary outcom es and decreases the burden on the healthcare system. The mechanism would re quire physician reporting at the be ginning and end of the care period, and may require a “start” and a “stop” m odifier to the new G-c ode. A few commenters specifically supported the “only once within 30 days of discharge” policy. The AMA’s C3W stipulated that the CPT TCM code s may be reported “...only once pe r patient within 30 days of discharge. Another CPT TCM code may not be reported by the same individual or group for any subsequent discharge(s) within the 30 days.” Response : In adopting the CPT TCM codes, we belie ve it is appropriate to maintain the limitation that the codes can be bi lled only once per patient within 30 days of discharge, which is consistent with the policy we proposed for our TCM G-code. Preven ting unnecessary hospital readmissions in the period shortly after a discharge is an importan t goal and part of the reason we proposed improved recognition and pa yment of TCM services (as well as other initiatives within the Medicare program). We believe that it would be at least inc onsistent with this goal, and perhaps even counterproductive to it, to allow for another TCM code to be billed when a hospital discharge occurs within 30 days after the original discharge for which a TCM code has been billed. We appreciate the comments recommendi ng that we monitor readmissions for patients receiving TCM services to determine if this e ffort positively impacts be neficiary outcomes and decreases the burden on the healthcare system. We will consider how to incorporate this into our306 existing initiatives that address these issues.
Comment : We proposed that the TCM G-code w ould be payable to a single community physician or nonphysician practitioner (or group pr actice) who assumes responsibility for the patient’s post-discharge TCM. Many comme nters recommended allowing more than one physician to bill a TCM code during the same 30-day period on the grounds that: “Complex patients often have to follow-up with more than one provider after a discha rge. Each of these providers could be performing care coordination and should be compensated accordingly.” The CPT TCM codes allow for only one individual to report these services and only once per patient within 30 days of discharge. Response : We disagree that more than one physic ian should be allowed to bill the TCM codes during a single 30 day period after a discharge. Coordinati on of care intrinsically involves developing and implementing a single plan of care for a patient. Allowing multiple physicians to furnish this service simultaneously would introdu ce the danger that an individual patient might be subjected to inconsistent or even contradictory plans of care. In other words, allowing more than one physician to bill TCM codes simultaneou sly could lead to uncoor dinated rather than coordinated post-discharge care. We will therefore follow the CPT TCM code rule that these services may be billed by only one indivi dual during the 30 day pe riod after discharge.
Comment : Other commenters recommende d further restricting and/ or raising the bar for billing TCM codes. Many objected to our pr oposal to pay the first physician or qualified nonphysician practitioner who submi tted a claim because, they asse rted, it would lead to an uncoordinated, sub-optimal “race to bill.” One of these commenters expressed concern that practitioners’ offices would have to compete with each other to subm it the bill first. In addition, this commenter was concerned that practitioners’ offices would not be able to track whether or not they are the first to submit a claim and could get paid for the service. MedPAC noted that the first physician or nonphysicia n practitioner to submit a claim may not be providing the bulk307 of the TCM services, and recommended raising the bar to ensure payment goes to physicians actually providing comprehensive primary care to the beneficiary by requir ing that the billing provider must have billed for an E&M visit (tha t is, a face-to-face visit) that took place within the 30 days prior to admission and within the 14 days following disc harge. Another commenter recommended that we adopt a multi-stage proc ess of screening claims to identify the beneficiary’s primary care physician, who then would be the only physician permitted to bill a TCM code. The commenter noted that we referr ed to the community-based physician as the one who would manage and coordina te a beneficiary's care in th e post-discharge period, and we anticipated that most community physicians will be primary care physicians and practitioners. The commenter also stated: “It is thus perplexing that CMS did not propose to restrict the use of this code to actual primary care physicians.” Others recommended employing a “plurality of services” determination in case more than one physician and/or nonphysician practitioner bills TCM after the same discharge. One comme nter recommended that we should require beneficiaries to prospectively id entify their primary care provider. Response Any physician who is appropriately en rolled in Medicare and furnishes the service may bill for that service. We continue to expect that most community physicians who are furnishing TCM services will be primary care physicians and practitioners. However, we also believe that there will be circumstances in which cardiologists, oncologists, or other specialists will be in the best position to furn ish transitional care coordination after a hospital discharge. Furthermore, we believe that the requirements for physicians or qualified nonphysician practitioners to furnis h multiple specific services for the beneficiary within a restricted period of time will limit the circum stances under which more than one practitioner might be able to bill the TCM codes. We appr eciate MedPAC’s suggestion that we require that the billing provider must have billed for an E/M vi sit (that is, a face-to-face visit) that took place within the 30 days prior to admission and within the 14 days following discharge. However we308 are concerned that adopting such a policy would actually have the unintended consequence of prohibiting many physicians with well-established rela tionships and a history of providing comprehensive care for their beneficiaries from reporting the TCM service for these same patients, simply because an office visit may not ha ve occurred within 30 days prior to a, possibly even unanticipated, hospitalizat ion. After considering all thes e comments, we continue to believe that it is not necessary to develop a ny further restrictions or complex operational mechanisms to identify one and only one physic ian or nonphysician practitioner who may bill the codes for a specific beneficiar y. We have used such a “first claim” policy in other areas, such as a radiology interpretation and the Annual Wellness Visit. However, we would expect the discharging physician to support TCM services by discussing post-discharg e services with the beneficiary (which is an element in the discha rge day management vignette), and to identify a community physician for follow-up whenever possibl e. Specifically, we expect discharging physicians and other physicians seeing beneficiaries in a facility to inform the beneficiaries that they should receive TCM services from their docto r or other practitioner after their discharge, and that Medicare will pay for those services. As a part of this disclosure to patients, we also expect that the discharging phys ician would ask the beneficiary to identify the physician or nonphysician practitioner whom he or she wishes to furnish these transitional care management services. If the beneficiary does not have a pr eference for the physician who would furnish these services, the discharging physician may suggest a specific physician who might be in the best position to furnish the TCM services . The recording of this information could also help in the transitional care coordination activ ities. We believe that it could be helpful for the physician providing discharge day management services to record the community physician who would be providing TCM services in the discharge medical record and the discharge instructions for309 patients. We note that recent literature highlig hts the importance of th ese patient-centered communication activities for effec tive transitional care management. 1 As we further consider how Advanced Primary Care practices can fit with a fee-for-service model, we also will actively consider methodologies that could allow Medicare to identify the beneficiary’s community/primary care physician.
Comment : Many commenters endorsed our proposal not to restrict billing of this proposed TCM code to primary care physicians. Other commenters requested that we confirm that specialists can bill the new code if they meet the service requirements of comprehensive TCM services. Other commenters similarly requ ested confirmation that they can bill the TCM code if they meet the requirements. Some co mmenters from health care professions other than physicians, NPs, PAs, CNSs, and CNMs similarly requested that they be permitted to bill the CPT TCM codes and receive payment for these services. Response : We appreciate these comments and take this opportunity to confirm that, while we expect the TCM codes to be billed most fr equently by primary care physicians, specialists who furnish the requisite services in the code de scriptions may also bill the new TCM codes. As for nonphysician qualified health care professiona ls, we believe only NPs, PAs, CNSs, and certified nurse midwives (CNMs) can furnish the full range of E/M services and complete medical management of a patient under their Medicar e benefit to the limit of their state scope of practice. Other nonphysician practiti oners (such as registered diet icians, nutrition professionals or clinical social workers) or limited-license practitioners, (such as opt ometrists, podiatrists, doctors of dental surgery or dent al medicine), are limited by the scope of their state licensing or their statutory Medicare benef it to furnish comprehensive medical evaluation and management services, and there is no Medicare benefit category that allows explicit payment to some of the

1 Hesselink MA, Schoonhoven L, Barach P et al. Improving patient handovers from hospital to primary care. Annals of Internal Medicine 2012; 157: 417-428.310 other health professionals (such as pharmaci sts and care coordinators ) seeking to bill TCM services. Accordingly, we will not adopt the requests of other hea lth care professionals to bill the CPT TCM codes because these services go be yond the statutory benefit and state scope of practice for the requesting practiti oners. As already discussed, we consider the separate coding and payment for these TCM services to be a short-term initiative as we further consider alternatives to ensure that any payment for primary care services would constitute a minimum level of care coordination, such as payments in a FFS setting.
Comment : Several commenters requested that we extend recognition of care coordination to RHC physicians and providers as well or at least clarify whethe r providers practicing in rural health clinics may utilize the new HCPCS G-code. Response : While we recognize that RHCs have an important role in furnishing care in their communities, RHCs are paid an all-inclusive rate per visit. Since RHCs are not paid under the PFS, physicians and other RHC providers w hose services are paid within the RHC allinclusive rate cannot bill using the CPT TCM codes for services furnished in the RHC. However, an RHC physician or other qualified provider who has a separate fee-for-service practice when not working at the RHC may b ill the CPT TCM codes, subject to the other existing requirements for billing under the MPFS.
Comment : We also proposed that the TCM G-code would be “billable only at 30 days post discharge or thereafter.” Although we propos ed that the billing for TCM services would occur, as it does for most services, after the conc lusion of the service that is, only at 30 days post discharge or thereafter), we welc omed comment on whether, in this case, there would be merit to allowing billing for the code to occur at the time the plan of care is established. Many commenters recommended that billing of TCM serv ices should occur (as proposed) at the end of the 30-day TCM period. A smaller number of commenters recommended that it should be allowed to occur at the time the plan of care is established. One commenter observed that billing311 for the post-transitional service at the time the pl an of care is established may help prevent a “race to the billing office” by various providers, as the appropriate provider coordinating the post-transitional care would be well-established among the various medical providers involved in the patient’s care. The CPT TCM code prefat ory language provides: "Only one individual may report these services and only once per patient within 30 days of discharge.” (Emphasis supplied.) Response : We continue to believe that th e billing for TCM services under the PFS should occur, as it does for most fee schedule servi ces, after the conclusion of the service (that is, only at 30 days post discharge or thereafter). Allo wing for billing at the time the plan of care is established, or at any other time prior to the end of the 30 day period, would pose serious administrative problems. For example, adopting a ny policy other than billi ng at the end of the 30 day service period would make it difficult to mon itor the CPT TCM requirement that the code be billed only once in the 30 day period beginning w ith the discharge. It would also be very challenging to monitor our policy that subsequent hospital admissions during that period will not begin a new 30 day period and allow reporting of another TCM service. We will provide guidance to physicians and qualified NPPs regard ing the billing of the CPT TCM codes, which will occur at the conclusion of the period for pr oviding TCM services, 30 days post discharge. We appreciate the concern about pr eventing a situation wh ere two physicians may rush to bill for TCM services. However, as we have previously discussed, we believe it would be quite unlikely that more than one physician or nonphysician practi tioner will be able simultaneously to satisfy the numerous and complex requirements for billing the CPT TCM codes.
Comment : Some commenters were concerned about the large number of activities that are required to furnish the TCM service. The commenters emphasized that many of the activities listed could require a lengthy disc ussion or actions that need to be undertaken with the patient that would far exceed that allowable time. Some commenters stated that the specific requirement312 that the physician communicat e with the patient with in 2 business days of discharge to begin the coordination of care is unrealistic because hosp ital discharge records are not always available that quickly. Other commenters pointed to the requirement for an assessment of the patient’s psychosocial needs as potentially an excessi vely burdensome requirement. One commenter asked us to reconsider the requirement that thes e codes only cover patients of moderate to high complexity on the grounds that most admissions are relatively straightforward and patients do not require moderate to complex decision making but that these less complex patients still require TCM services. On the other hand, so me commenters recommended additions to the services already listed, such as the additi on of communication between the accepting primary care/community physician and the discharging inpatient physician. Response : We agree with the commenters that a la rge number of activities are required to report the TCM codes. However, we believe that these requirements are entirely appropriate. As we have noted before, TCM services require management and coordination of all relevant aspects of a beneficiary’s health status in the post-discharge period. And as a number of commenters maintained, physicians should not undertake TCM serv ices unless they are capable and willing to assume comprehensive responsibilit y for a patient’s care during the period of the service. In the light of these considerations, we believe the lengthy list of services required by our proposed G-code, and largely paralleled in the AMA’s CPT TCM codes that we are adopting in this final rule, is quite appropriate to the natu re of the service. With regard to the specific requirement for assessment of psychosocial needs, we note again for example that depression in older adults occurs in a comp lex psychosocial and medical cont ext and opportunities are often missed to improve behavioral health and genera l medical outcomes when mental disorders are under-recognized and undertreated in primary care settings. We believe that it is therefore important to emphasize the equal importance of the beneficiary’s mental health and his or her physical condition to successful discharge into the community. We believe that AMA has313 confirmed our assessment by requiring those reporting the CPT TCM codes to oversee the “management and coordination of services, as needed, for all medical conditions, psychosocial needs and activity of daily living supports...” Th e AMA has also confirmed our assessment that patients typically require complex and multidisci plinary care modalities in the post-discharge period by establishing a requirement of moderate to high complexity for reporting the CPT TCM codes. We do not believe that it is necessary to add a formal requirement for communication between the accepting primary care/community physician and the discharging inpatient physician. The accepting community physician is responsible for reviewing the discharge summary, and the community physician can decide whether standard clinical practice indicates the need for further communication with the di scharging physician. However, as indicated above, we note our expectation that the disc harging physician will communicate with the community physician as necessary as part of bi lling for discharge day management services.
Comment : Some commenters recommended that we create disease specific TCM codes for major chronic conditions (f or example, Alzheimer’s, diab etes, HIV, cancer survivors planning services, etc.) or for special servic es (for example, comprehensive medication management services). The commenters were concerned that, otherwise, many cognitive specialists and other practiti oners would not be able to bill the proposed TCM G-code. Response : With regard to treatment of the ch ronic conditions mentioned by commenters, both our proposed TCM G-code and the CPT TCM c odes we are adopting in this final rule are defined broadly enough to incorporate the TCM activ ities involved in the treatment of patients with such diseases in the period after discharge. In addition, as we discuss below, we will be considering adoption of the complex care coor dination codes developed by the AMA as we continue to explore payment for primary care services in future rulemaking. With regard to the TCM codes, we indicated in the proposed rule that we proposed the TCM G-code to recognize the services related to TCM by a community phys ician or qualified nonphysician practitioner.314 We used the term community physician and pr actitioner to refer to the community-based physician managing and coordinating a beneficiary’s care in the post- discharge period. We also indicated that we anticipated that most commun ity physicians would be primary care physicians and practitioners. This is because the nature of the services involved in TCM (for example, communication with patient and family educa tion to support self-management, independent living, and activities of daily liv ing, assessment and support for treatment regimen adherence and medication management, etc.) are characteristic of primary care services as such services are usually understood. At the same time, neither the TCM G-code we proposed, nor the CPT TCM codes we are adopting in this final rule, preclu de cognitive or other sp ecialists from reporting these codes when they are appropriately furnishi ng the required primary car e services of TCM. We certainly want to encourage cognitive and other specialists to assume responsibility for the comprehensive care of patients contemplated in the requirements of the CPT TCM codes when they are in the position to do so during the post-discharge period.
Comment : A few commenters recommended that there should be special TCM G-codes for psychologists and others who are not permitted to bill E/M codes. Response : The TCM service includes “the manage ment and/or coordination of services, as needed, for all medical conditions, psychosocia l needs and activities of daily living.” For reasons we have discussed at length above, the services descri bed in the CPT E/M codes are intrinsic to furnishing the TCM service. It was fo r this reason that the AMA decided to include a post-discharge, face to face E/M service as a re quirement for reporting the CPT TCM codes. We have had a longstanding restriction on the use of E/M codes by clinical psychologists. As we have explained in previous rulemaking (62 FR 59057), the evaluation and management services included in the codes that psychologis ts cannot bill are services involving medical evaluation and management. Psychologists are not licensed to pe rform these types of services. Therefore, we do not believe it would be appropriate to provide a special TCM G-code for these practitioners.315 However, we would expect the community physic ians and qualified nonphysician practitioners to refer patients to psychologists and other ment al health professionals as part of the TCM service when doing so is warranted by evaluatio n of patients’ psychosoc ial needs in the period after discharge. As indicated above, we be lieve the only nonphysician practitioners who may furnish the full range of E/M services and comple te medical management of a patient under their Medicare benefit are NPs, PAs, CNSs, and CN Ms, unless they are otherwise limited by their state scope of practice. Other nonphysician practitio ners or limited-license practitioners, (such as optometrists, podiatrists, doctors of dental surgery or dental medicine), are limited by the scope of their state licensing or their Medicare be nefit from furnishing comprehensive medical evaluation and management services. As already discussed, we consider these TCM services to be a short-term initiative as we further consider alternatives to target payment for primary care services.
Comment : Some commenters cited our statement that the proposed TCM G-code may be used “[d]uring transitions in care from hospital (inpatient stay, outpatient observation, and partial hospitalization), SNF stay, or CMHC settings to community-based ca re.” The commenters stated that this statement seems to avoid the r eality that in many instances the transition from a hospital to a facility such as a SNF is, for all intents and purposes, the transition back to the community for many patients. Response : Individuals in SNFs are considered inpatients, and therefore the TCM codes may not be billed when patients are discharged to a SNF. For patients in SNFs there are E/M codes for initial, subsequent, discharge care, a nd the visit for the annual facility assessment, specifically CPT codes 99304-99318. These codes ma y be billed for SNF beneficiaries for the care management services they receive in the peri od after discharge from an acute care hospital. And then when SNF patients are discharged fr om the SNF to the community or to a nursing facility (even when the SNF and nursing facility are part of the same entity or located in the same316 building), the physician or practi tioner who furnishes transitional care management services can use the CPT TCM codes to bill for those services. As such, we believe there will be appropriate payment for transitional care management services furnished following each transition of care from acute inpatient, to SNF, to the comm unity or nursing facility setting. After considering all these comments, and fo r the reasons stated above we are adopting the CPT TCM codes subject to the modifications described in our responses to comments on the issues discussed above. In summary, these specific modifications are: our decision not to restrict the billing of the CPT TCM codes to established patients, our clar ification of the post-discharge service period, and our prohibiti on against billing a discharge day management service on the same day that a required E/M visit is furnished under the CPT TCM codes for the same patient. We will provide guidance to contractors and revi se the relevant manual provisions in order to implement these policies. Below are the requirements of the CPT TCM co des as modified for Medicare purposes in this final rule.

● 99495 Transitional Care Management Services with the following required elements: ++ Communication (direct contact, telephone , electronic) with the patient and/or caregiver within 2 busine ss days of discharge. ++ Medical decision making of at least mode rate complexity during the service period. ++ Face-to-face visit, within 14 calendar days of discharge.

● 99496 Transitional Care Management Services with the following required elements:

++ Communication (direct cont act, telephone, electronic) w ith the patient and/or caregiver within 2 busine ss days of discharge.

++ Medical decision making of high comp lexity during the service period.

++ Face-to-face visit, within 7 cal endar days of discharge. CPT codes 99495 and 99496 are used to report transitional care management services.317 These services are for a patient whose medical a nd/or psychosocial problems require moderate or high complexity medical decision making during tr ansitions in care from an inpatient hospital setting (including acute hospital, rehabilitation hospital, long-term acute care hospital), partial hospital, observation status in a hospital, or sk illed nursing facility/nursing facility, to the patient’s community setting (home, domiciliary, rest home, or assi sted living). Transitional care management commences upon the date of disc harge and continues for the next 29 days. Transitional care management is comprised of one face-to-face visit within the specified time frames, in combination with non-face-to-f ace services that may be performed by the physician or other qualified health care professional and/or licensed clinical staff under his or her direction. It is our expectation that the servi ces in the two lists of non-face-to-face services below will be routinely provided as part of transitional care management service unless the practitioner’s reasonable assessment of the patient indicates that a part icular service is not medically indicated or needed. Non-face-to-face services provided by clinical staff, under the direction of the physician or other qualified health car e professional, may include:

● Communication (direct contac t, telephone, electronic) with the patient and/or caregiver within 2 business days of discharge.

● Communication with home health agencies and other community services utilized by the patient.

● Patient and/or family/car etaker education to support se lf-management, independent living, and activities of daily living.

● Assessment and support for treatme nt regimen adherence and medication management.

● Identification of available co mmunity and health resources.

● Facilitating access to care and services needed by the patient and/or family.318 Non-face-to-face services provided by the physician or other qualified health care provider may include:

● Obtaining and reviewing the discharge in formation (for example, discharge summary, as available, or conti nuity of care documents).

● Reviewing need for or follow-up on pending diagnostic tests and treatments.

● Interaction with other qualified health care professionals who will assume or reassume care of the patient’s system-specific problems.

● Education of patient, fam ily, guardian, and/or caregiver.

● Establishment or reestablishment of re ferrals and arranging for needed community

resources.

● Assistance in scheduling any required follow-up with community providers and services. Transitional care management requires a face-to-face visit, initial patient contact, and medication reconciliation within specified time frame s. The first face-to-face visit is part of the transitional care management service and not report ed separately. Additi onal E/M services after the first face-to-face visit may be reported separa tely. Transitional care management requires an interactive contact with the pa tient or caregiver, as appropria te, within 2 business days of discharge. The contact may be direct (face-t o-face), telephonic, or by electronic means. telephonic, or by electronic means. Medicati on reconciliation and mana gement must occur no later than the date of the face-to-face visit. Medical decision making and the date of the fi rst face-to-face visit ar e used to select and report the appropriate transitional care management code. For 99496, the face-to-face visit must occur within 7 cale ndar days of the date discharge and me dical decision making must be of high complexity. For 99495, the face-to-face visit must o ccur within 14 calendar days of the date of discharge and medical decisi on making must be of at least moderate complexity.319 Medical decision making is defined by the E/M Services Guidelines. The medical decision making over the service pe riod reported is used to define the medical decision making of

transitional care management . Documentation includes the timi ng of the initial post discharge communication with the patient or caregivers, date of the face-to-face visit, and the complexity of medical decision making. (The E/M Services Guidelines define leve ls of medical decision making on the basis of the following factors:

● The number of possible diagno ses and/or the number of ma nagement options that must be considered;

● The amount and/or complex ity of medical records, diag nostic tests, and/or other information that must be obtaine d, reviewed, and analyzed; and

● The risk of significant complications, morbidity, and/or mortality as well as comorbidities associated with th e patient’s presenting problem(s), the diagnostic procedure(s), and/or the possible management options. Medical decision making of moderate complexity requires multiple possible diagnoses and/or the management options, moderate complexity of the medical data (tests, etc.) to be reviewed, and moderate risk of significant complications, morbid ity, and/or mortality as well as comorbidities. Medical decision making of high complexity requir es an extensive number of possible diagnoses and/or the management options, extensive complex ity of the medical data (tests, etc.) to be reviewed, and a high risk of si gnificant complications, morbidit y, and/or mortality as well as comorbidities) Only one individual may report these services and only once pe r patient within 30 days of discharge. Another transitional care manageme nt service may not be reported by the same individual or group for any subs equent discharge(s) within th e 30 days. The same individual may report hospital or observation discharge serv ices and transitional care management. The320 same individual should not report transitional care management services provided in the postoperative period for a serv ice with a global period. A physician or other qualified health care professional who reports codes 99495, 99496 may not report care plan oversight serv ices (99339, 99340, 99374-99380), prolonged services without direct patient co ntact (99358, 99359), anticoagul ant management (99363, 99364), medical team conferences (99366-99368), education and trai ning (98960-98962, 99071, 99078), telephone services (98966-98968, 99441-99443), end stage renal diseas e services (90951- 90970), online medical evaluation services ( 98969, 99444), preparation of special reports (99080), analysis of data (99090, 99091), complex chronic care coordina tion services (99481X99483X), medication therapy management serv ices (99605-99607), during the time period covered by the transitional care management services codes. It is very important to emphasize that we consider the non-face-to-face services to be furnished by physicians, qualified health care prof essionals, and clinical st aff to be intrinsic, indeed essential, components of the TCM code s. To support the non-face-to-face services, the TCM service requires a f ace-to-face visit, initial patient c ontact, and medication reconciliation within specified time frames. Th e first face-to-face vis it is part of the TC M service and may not be reported separately. Additi onal reasonable and necessary E/M services required for managing the beneficiary’s clinical issues in addition to the face-to-face visit may be reported separately. Despite the importance of the face-to-face serv ice that is a required element of the CPT TCM codes, the non-face-to-face services su ch as communication, referrals, education, identification of community resources, and medication management constitute the truly essential features that distinguish TCM fr om those services that are pre dominantly or exclusively face-toface in nature. We are adopting these new CPT TCM codes to provide a separate reporting mechanism for the community physician for these services in the context of the broader CMS multi-year321 strategy to recognize and support primary care and care management. Therefore, we plan to monitor the use of the transitiona l care management billing codes. We wish to emphasize again that the policies we are finalizing in this final rule may be short- term payment strategies that may be modified and/or revised over time to be c onsistent with broader primary care and care management initiatives. Because CPT TCM codes 99495 and 99496 are new codes, they will be valued and designated as interim final in this final rule with comment period and subject to public comment. We would also note that this proposal coincides with our disc ussion under section III.J. of this final rule with comment period on the Value-based Payment Modifier and Physician Feedback Reporting Program which discusses hospital admission measures and a readmission measure as outcome measures for the proposed value-based payment modifier adjustment beginning in CY 2015. c. Proposed Payment for Post-Discharge Transitional Care Management Service To establish a physician work relative value unit (RVU) for the proposed post-discharge TCM, HCPCS code GXXX1, we compared GXXX1 with CPT code 99238 (Hospital discharge day management; 30 minutes or less) (work RVU = 1.28). We recognized that, unlike CPT code 99238, HCPCS code GXXX1 is not a face-to-face visit. However, we believed that the physician time and intensity involved in post- discharge community care management is most equivalent to CPT code 99238 which, like the proposed new G code, involves a significant number of care management services. Theref ore, we proposed a work RVU of 1.28 for HCPCS code GXXX1 for CY 2013. We also proposed th e following physician times: 8 minutes preevaluation; 20 minutes intra-serv ice; and 10 minutes immediate pos t-service. In addition, we proposed to crosswalk the clin ical labor inputs from CPT code 99214 (Level 4 established patient office or other outpatient visit) to proposed HCPCS code GXXX1. For malpractice expense, we proposed a malpractice crosswal k of CPT code 99214 for HCPCS code GXXX1 for322 CY 2013. We believe the malpractice risk fact or for CPT code 99214 appropriately reflects the relative malpractice risk associ ated with furnishing HCPCS c ode GXXX1. In our proposal, we noted that, as with other services paid under the PFS, the 20 percent be neficiary coinsurance would apply to the post-discharge TCM serv ice as would the Part B deductible.
Comment : Several commenters recommended that we await the recommendations of the RUC and accept the RUC RVU values, so that we can fully take into account feedback from practicing physicians of all specialties before finalizing values for these non-face-to-face, care management services. With regard to the pr oposed RVU for physician work, a few commenters noted that our source code for GXXX1 included only 30 minutes of work for the discharging physician for whom most of the information is more readily available and that that time understates the effort required of the receiving physician. The co mmenters urged us to consider the significant potential variability in time and effort for the receiving physician. Another commenter urged CMS to utilize the work RVUs used for care plan oversight HCPCS codes G0181 and G0182 in valuing the new code. With regard to PE, another commenter recomm ended that we assign clinical staff type RN/LPN only for the clinical staff work for the TCM codes because those are the only two clinical staff types who furnish clinical staff TCM activities. A commenter noted that this proposal largely ignores equipmen t costs (for example, computer , electronic health record, and telephone) that are essential to fu rnishing this service, and urged us to reconsider whether 1.41 is an appropriate practice expense RVU amount. A nother commenter noted that our source code for practice expense, CPT code 99214, is for modera te complexity decision-making and that we should consider the greater costs associated with a patient of high complexity. One commenter agreed with our proposed malpractice value. Response : We agree with commenters that a ny valuation under th e PFS should benefit from as much public review and input as possi ble, including review by the AMA RUC. The323 AMA RUC conducted a multi-specialty survey of 110 physicians and recommended an RVU for each of the new CPT TCM codes. For CPT code 99495, the AMA RUC recommended the median survey work RVU of 2.11 with 40 minutes of intra-service time, and for CPT code99496, the AMA RUC recommended the median work RVU of 3.05 with 60 minutes of intraservice time. For CPT code 99496, we disagree w ith the observed median intra-service time of 60 minutes. We believe that 50 minutes of intra- service time is a more appropriate intra-service time for CPT code 99496. We observe that th e primary reference code for CPT code 99495, CPT code 99214, has 25 minutes of intra-service time. We conclude that the typical physician time engaging in additional non- face-to-face activities and ov erseeing clinical staff care management activities is the difference between the intra-service time for CPT code 99214 and median intra-service time for CPT code 99495, 15 mi nutes. We believe that 50 minutes of intraservice time is more appropriate for CPT code s 99496 because it adds the additional non-face-toface care management time of 15 minutes, to the intra-service time for the primary reference CPT code 99496, which is CPT code 99215 with an intra-service time of 35 minutes. We appreciate comments suggesting that we value our proposed G-code, GXXX1, comparable to CPT codes G0180 and G0181. Howe ver, because we not finalizing the proposed G-codes and instead are adopting the CPT TCM codes on an interim final basis in this final rule with comment period, we believe that the AMA RUC recommendation, which reflects the services we included in the proposed G-code as well as a face-to-face visit, is a more basis for appropriate valuation. In re sponse to comments noting that the discharge day management source code, CPT code 99238, for GXXX1, does not contain sufficient time for the receiving physician and that the time does not reflect differences in the co mplexity of decision-making, we note that we are adopting AMA RUC recomme nded times as modified in the preceding paragraph on an interim final basis, with re finement, which include a longer time than the proposed time of 30 minutes, and those times are sp ecific to the level of complexity. We also324 note that there is a significant amount of clinical labor time incorporated in the practice expense calculation for these codes. In summary, we are assigning a work RVU of 2.11 to CPT TCM code 99495 with intra-service time of 40 minutes, and a work RVU of 3.05 with intra-service time of 50 minutes. The work RVUs included in Addendum B to this final rule with comment period reflect these interim final values. The phys ician time file associated with this PFS final rule with comment period is available on the CMS website in the Downloads section for the CY 2013 PFS final rule with comment period at www.cms.gov/PhysicianFeeSched/

. Consistent with our policy discussed in sec tion II.C.1. of this fina l rule with comment period for assigning malpractice RVUs, we deve loped malpractice RVUs for the new CPT TCM codes. For CPT code 99495, the AMA RUC recomme nded a malpractice risk factor crosswalk to CPT code 99214, resulting in a malpractice RVU of 0.14 for CPT code 99495. For CPT code 99496, the AMA RUC recommended a malpractice risk factor crosswalk to CPT code 99215, resulting in a malpractice R VU of 0.20 for CPT code 99496. We are accepting the AMA RUC’s recommended malpractice crosswalks for CPT codes 99495 and 99496 on an interim final basis. We appreciate comments in support of our propos ed malpractice value for our non-face-to-face G-code, GXXX1, of 0.09. We believe that th e interim final malpractice crosswalks recommended by the AMA RUC provide appropriate malpractice values for the CPT TCM codes, which include a face-to-face visit. For practice expense, we are accepting the AMA RUC-recommended practice expense inputs for these codes with one refinement to clinical labor time for CPT code 99496. We are refining the 60 minutes of recomme nded clinical labor time for a RN/LPN nurse blend dedicated to non-face-to-face care management activities from 60 minutes to 70 minutes. We believe that the total clinical labor staff time and physician intra-se rvice work time that the AMA RUCrecommended for non-face-to-face care manageme nt activities was accurate, but that the proportionality between physician work and clinical staff time should be refi ned to reflect greater325 clinical staff time. In respons e to the comment on appropriate c linical staff type for non-face-toface care management services, we note th at we are accepting th e AMA RUC recommended clinical labor staff type of an RN/LPN for conducting non-face-to-face care coordination activities. The AMA RUC did not include additi onal costs for computer, EHR, and telephone in their recommendations. We believe accounting fo r the infrastructure required to furnish advanced primary care services is an issue we will consider as we pur sue the broader HHS and CMS multi-year strategy to recognize and supp ort primary care and care management under the
MPFS. The CY 2013 final rule with comment period direct PE input database reflects these inputs and is available on the CMS website under the supporting data files for the CY 2013 PFS final rule with comment period at www.cms.gov/PhysicianFeeSched/ . The PE RVUs included in Addendum B to this final rule with comment peri od reflect the RVUs that resulted from adopting these interim final values. For BN calculations, we estimated that physic ians or qualified nonphysician practitioners would furnish post-discharge TCM services for 10 million discharges in CY 2013. We estimated that this number roughly consid ers the total number of hospital inpatient and SNF discharges, hospital outpatient observation services and part ial hospitalization patients that may require moderate to high complexity deci sion-making following discharge.
Comment : Some commenters indica ted that our estimate of the number of claims we would receive for the transitiona l care services was overstate d. Using a different set of assumptions, the AMA RUC commented that the numbe r of billings would be closer to 2 million per year. The AMA RUC provided us with deta iled utilization assumptions for the CPT TCM codes. These detailed utilization assumptions indicated physicians would bill 2,166,719 claims in CY 2013 for the CPT TCM codes, with 60 percent of those claims for CPT TCM code99495 and 40 percent for CPT TCM code99496. Commenters also indicated that we should offset the326

cost of the TCM codes in our BN calculation with savings from reduced readmissions to hospitals and other facilities. Response : The estimate of the num ber of billings we will receive in CY 2013 for TCM services is sensitive to the utilization assumptions used a nd cannot be easily derived from existing codes. The number of discharge day mana gement visits that are billed to Medicare is approximately 10 million. As reflected in the RUC recommendations, we agree with commenters that this is a reasonable starting poin t in the development of the estimate for the number of billings for the TCM services. The next step is to determine how many of these discharges will be readmissions in CY 2013. Since the patient would only be eligible fo r one TCM service associ ated with a hospital discharge and the late r readmission, we are not counting th e readmission in our utilization estimate. The AMA RUC used an estimate of 19.6 percent. We disagree with this estimate. More recent work by MedPAC indicates that th e all cause readmission rate was closer to 15 percent in CY 2011. 2 Accordingly, we adopted a 15 percent readmission rate. The AMA RUC also cited a variety of factor s that it believes will reduce the number of billings from the universe of discharges, includi ng the number of patients requiring moderate or high complexity decision-making based on the percen tage of high cost Medicare patients in the Medicare population, the number of patients currently seen within 14 days of discharge, discharges where the primary care physician didn't know patient was in the hospital, cases where the patient couldn't be contacted or seen, cases where the patient died, cases where the patient changed doctors or didn't see the primary care doctor, and cases for which physicians will not furnish the TCM service as rapidly as we have assumed. The AMA RU C provided assumptions

2 MedPAC September 7, 2012 Public Meeting Transcript, page 94, at http://medpac.gov/transcripts/092012_transcript.pdf ,, or slide 4 at http://www.medpac.gov/transcripts/readmiss ions%20Sept%2012%20presentation.pdf

.327 about the number of discharges it believes will not result in the billing of a TCM service. We have posted the AMA RUC calculation on our website at www.cms.gov/PhysicianFeeSched/

. While we generally agree that some of these f actors will impact the billings for the TCM code, we believe that the construct of the RUC estimat e with assumed exact values for each and every one of these factors understa tes the likely TCM billings. In considering this and similar comments, we examined the current distribution of the inpatient, observation, and nursing facility evaluation and management codes. Within each of these families, we also examined the severity of the presenting problems and the level of complexity of the medical decision-making to he lp differentiate the codes. We found that 85 percent of Hospital Observation and Initial and Subsequent Hosp ital Care services (CPT codes 99218-99233) were at Level 2 or Level 3, generally indicating moderate to high severity and complexity. We note that over 90 percent of pl ace of service designations for the discharge codes are inpatient or outpatient hospital. We found that 43 pe rcent of Nursing Facility Care services (CPT codes 99304-99310) were at Level 2 or Level 3, generally i ndicating moderate to high severity and complexity. Although less releva nt for the TCM policy, we also examined the Office or Other Outpatient visits (CPT c odes 99201-99213) as a point of comparison and found that 41 percent of services were at Level 4 or Level 5, generally indi cating moderate to high severity and complexity. In light of the data on the current severity and complexity levels of the evaluation and management services, and after consideration of the factors included in the AMA RUC estimate and removing 15 percent for readmissions, we believe that two-thirds of the discharges reflected in the discharge day management codes, are likel y to result in TCM claims. This represents approximately 5.7 million claims [=10 million discha rges * (1-.15) for readmissions * (2/3) for severity and other factors)]. We disagree with the RUC that 60 percent of those claims will be for 99495 and 40328 percent for 99496. In looking at the relations hip between the modera te and high Hospital Observation and Initial and Subsequent Hosp ital Care services (C PT codes 99218-99233) and the relationship between the moderate and high Nursing Facility Care services (99304-99310), we believe a more reasonable estimate is that 75 percent of the TCM claims will be for 99495 and 25 percent for 99496. Because the practice expense RVUs for the tr ansitional care codes will vary depending on whether or not the service is bi lled in a facility or non-facility setting, , we also need to further refine the estimate to determine the proportion of TC M services that will be paid at the facility rate versus the non-facility rate. After examining the facility and non-facil ity distribution of the 99214 and 99215 visit codes billed by primary care spec ialties, we believe that 92 percent of the TCM services will be billed in the non-facility setting. Lastly, we agree with the RUC that 26 percent of patients had at leas t one visit within 7 calendar days of discharge and 44 percent had one within 14 days of discharge. Because these are existing visits that will potenti ally now be billed as part of the TCM service, we partially offset the cost of the TCM services with the cost of the existing visits assumed to be billed as part of the CPT TCM code. For the comments requesting that we also offs et the cost of the CPT TCM codes in our BN calculation with savings from reduced r eadmissions, there are currently many efforts underway to reduce hospital readmiss ions. We do not believe that it would be possible to isolate the effect of payment for TCM services on the readmission rate. Furthermore, the statute does not permit costs or savings from outside of the ph ysician fee schedule to be used in the physician fee schedule BN calculation. For purposes of the Primary Care Incentive Payment Program (PCIP), we proposed to exclude the post discharge TCM services from the total allowed charges us ed in the denominator calculation to determine whether a physician is a primary care practiti oner. Under section329 1833(x) of the Act, the PCIP provides a 10 percen t incentive payment for primary care services within a specific range of E/M services when fu rnished by a primary care practitioner. Specific physician specialties and qualified nonphysician pr actitioners can qualify as primary care practitioners if 60 per cent of their PFS allowed charges are primary care services. As we explained in the CY 2011 PFS final rule (75 FR 73435-73436), we do not believe the statute authorizes us to add codes (additional services) to the definition of primary care services. However, to avoid inadvertently disqualifyi ng community primary care physicians who follow their patients into the hospital setting, we finalized a policy to remove allowed charges for certain E/M services furnished to hospital inpatients and outpatients from the total allowed charges in the PCIP primary ca re percentage calculation. In the proposed rule, we also proposed that the TCM code should be treated in the same manner as those services for the purposes of PC IP because post-discharge TCM services are a complement in the community setting to the ho spital-based discharge da y management services already excluded from the PCIP denominator. Similar to the codes already excluded from the PCIP denominator, we expressed concern that inclusi on of the TCM code in the denominator of the primary care percentage calcu lation could produce unwarranted bias against “true primary care practitioners” who are involved in furnishi ng post-discharge care to their patients. Therefore, while physicians and qualified nonphysic ian practitioners who furnish TCM services would not receive an additional incentive payment under the PCIP for the se rvice itself (because it is not considered a “primary care service” fo r purposes of the PCIP), the allowed charges for TCM services would not be incl uded in the denominator when calculating a physician’s or practitioner’s percent of allowed charges that we re primary care servic es for purposes of the
PCIP.
Comment : Some commenters reco mmended that the proposed TCM G-codes should be eligible for the PCIP. The commenters acknowle dged that, to add our proposed G-code to the330 codes eligible for PCIP, we would have to re vise our previous inte rpretation concerning the extent of the Secretary’s discre tion to modify the list of primary care E/M services eligible for PCIP. However, the commenters st ated that our previous interpre tation of the statutory language was incorrect, or at least not the only reasonable interpretation of the statutory language. A few commenters opposed excluding the a llowed charges for TCM services from the denominator of the ratio used to determine qualification for the PCIP. Response : We continue to believe that the st atute does not permit us to add codes (additional services) to the statut ory definition of primary care serv ices, which is a range of E/M services including office visits. The new CPT TCM codes fall outside the designated range of codes that qualify for the PCIP. Therefore, we cannot agree with those commenters who contended that it is permissible to add the new TCM codes to the lis t of codes eligible for PCIP. However, to avoid disadvantaging physicians w ho furnish post-discharge TCM services to their patients, we are finalizi ng our proposal to exclude the allo wed charges for TCM services from the denominator when calculating a physician’s or practitioner’s percent of allowed charges that were primary care services for purposes of the PCIP.
Comment : Many commenters urged us not to apply the 20 percent beneficiary coinsurance to TCM services. Some commenters stated a belief that we should categorize TCM as a preventive service and that we should therefore waive the coin surance for the service. Other commenters expressed concern that beneficiaries will not understand their coinsurance liability for this service, since our proposed new post-di scharge TCM G-code woul d not include a faceto-face visit. Some commenters were also concer ned that this confusion would lead to increased bad debt for physicians and qualified NPPs billin g the CPT TCM codes. Others urged us to work with the Congress to enact legislation to waive the beneficiary coinsurance for postdischarge care management services. On the other hand, some commenter s noted that requiring a face-to-face E/M visit when billing the TC M code would reduce potential beneficiary331

confusion about the coinsurance for the TCM service. Response : We appreciate the reasons commente rs have offered for waiving the beneficiary coinsurance for TCM as a preventive se rvice. However, we do not believe we have authority to do so through the rulemaking process. This is because section 1861(ddd)(1)(B) of the Act requires, among other criteria, that “addi tional preventive services” can be added only if such services are recommended with a grade of A or B by the United States Preventive Services Task Force. We lack such a recommendation re garding the services described by the new CPT TCM codes. As we have discussed above, we agree with those commen ters who observed that requiring a face-to-face E/M visit when billing th e TCM code would reduce potential beneficiary confusion about the coinsurance for the TCM servi ce. Now that we have modified our proposal for a TCM service to include a face-to-face servi ce, beneficiaries will experience a face-to-face encounter to which they can relate their copayments for the servic e. We therefore believe that our adoption of the CPT TCM codes that include a required face-to-face vi sit as a component of the service will greatly reduce th e potential for beneficiary confusion over the coinsurance for the service and the possi bility of increased bad debt for physicians. 2. Primary Care Services Furnished in Advanced Primary Care Practices a. Background As we discussed above, we are committed to considering new options and developing future proposals for payment of primary care se rvices under the MPFS. Such options would promote comprehensive and continuous assessm ent, care management, and attention to preventive services that constitute effective primary care by establis hing appropriate payment when physicians furnish such services. One pot ential method for ensuring that any targeted payment for primary care services would const itute a minimum level of care coordination and continuous assessment under the MPFS would be to pay physicians for services furnished in an “advanced primary care practice” that has implemented a medical home model supporting332 patient-specific care. The medical home model has been the subject of extensive study in medical literature. Since 2007, the AMA, American Academy of Family Physicians (AAFP), the American Academy of Pediatrics (AAP), the American College of Physicians (ACP), and the American Osteopathic Association (AOA), and many other physician organizations have also endorsed “Joint Principles of the Patient-Cent ered Medical Home.” In February 2011, the AAFP, the AAP, the ACP, and AOA also publishe d formal “Guidelines for Patient-Centered Medical Home (PCMH) Recognition and Accreditation Programs” to develop and promote the concept and practice of the PCMH. (These guidelines are available at www.aafp.org/online/etc/medialib/aafp_org/docum ents/membership/pcmh/pcmhtools/pcmhguid elines.Par.0001.File.dat/GuidelinesPCMH RecognitionAccred itationPrograms.pdf .) As we have discussed above, the Innovation Center has been conducting seve ral initiatives based on the medical home concept. The medical home concept emphasizes establis hing an extensive infr astructure requiring both capital investments and ne w staffing, along with sophisticat ed processes, to support continuous and coordinated care with an em phasis on prevention and early diagnosis and treatment. The literature, reports, and guideline s dealing with the medical home concept define the requisite elements or functions that constitu te this infrastructure and processes in various ways. For example, the Innovation Center’s CPC initiative identified a set of five “comprehensive primary care functions,” which form the service delivery model being tested and the required framework for pr actice transformation under the CP C initiative. In the proposed rule (77 FR 44780), we discusse d these five “comprehensive pr imary care functions” as an appropriate starting point for di scussing the incorporation of th e comprehensive primary care services delivered in advanced primary care practices (practic es implementing a medical home model) into the MPFS. These five functions are: risk-stratified care management, access and continuity, planned care for chronic conditions and preventive care, patient and caregiver333 engagement, and coordination of care acro ss the medical neighborhood. (See our detailed discussion of these functions at the citation noted above.) In the proposed rule, we also discussed the need to establish a set of parameters to determine whether or not a clinical practice c ould be considered an advanced primary care practice (medical home) in the event that we were to establish an enhanced payment for primary care services furnished to Medicare benefici aries in an advanced primary care practice environment. (77 FR 44781-44782) Specifically, we discussed two possible approaches to determining whether a practice has implemented all the necessary functions to be considered an advanced primary care practice or medical home. One approach would be to recognize one or more of the nationally available accreditation prog rams currently in use by major organizations that provide accreditation for advanced primar y care practices, frequently credentialed as “PCMHs.” We identified four national models that provide accreditation for organizations wishing to become an advanced primary care practice; the Accredit ation Association for Ambulatory Health, The Joint Commission, th e NCQA, and the Utilization Review Accreditation Commission (URAC). Alternatively, we could develop our own criteria using, for example, the five functions of comprehensiv e primary care used in the CPC initiative and described above, to determine what constitutes advanced primary care for purposes of Medicare payment. We would then need to develop a process for determining whether specific physician practices meet the criteria for advanced prim ary care. This could include creating our own processes for review or could include using existing accrediting bodies to measure compliance against advanced primary care criteria determined by CMS. We also discussed another potential issu e surrounding comprehensive primary care services delivered in an advanced primary care practice, specifical ly attribution of a beneficiary to an advanced primary care practice. (77 FR 44782) In a fee-for-service environment we would need to determine which practice is cu rrently serving as the advanced primary care334 practice for the beneficiary to en sure appropriate payment. One method of attribution could be that each beneficiary prospectively chooses an a dvanced primary care practice. Other attribution methodologies might examine the quantity and ty pe of E/M or other designated services furnished to that beneficiary by the practice. We welcomed input on the most appropriate approach to the issue of how to best determine the practice that is functioning as the advanced primary care practice for each beneficiary. We emphasized that we would not consider proposals that would restrict a benefi ciary’s free choice of practitioners. In summary, we stated our belief that ta rgeting primary care management payments to advanced primary care practices could have many merits, including ensuring a basic level of care coordination and care management. We recognize that the advanced pr imary care model has demonstrated efficacy in improving the value of health care in several contexts, and we are exploring whether we can achieve these outco mes for the Medicare popul ation through several demonstration projects. Careful analysis of th e outcomes of these demonstration projects will inform our understanding of how this model of care affects the Medicare population and of potential PFS payment mechanisms for these servi ces. At the same time, we also believe that there are many policy and operational issues to be considered when nationally implementing such a program within the PFS. Therefore, we generally invited broad public comment on the accreditation and attribution issues discussed abov e and any other aspect, including payment, of integrating an advanced primary care model into the PFS. We received many helpful and informative comments on the issues we discussed in relation to recognizing advanced primary care practices, especially on the criteria and processes that should be used to identif y such practices. We welcome these comments because we are actively considering such an advanced primary care practice model in th e near future after a complete assessment of the results of ongoing demonstratio ns and policy and operational considerations.335 We also received many comments recommending that we adopt the complex care coordination codes developed by the AMA’s C3 W for CY 2013. As discussed in section III.M.3.a. of this final rule with comment period, o n an interim final basis for CY 2013, we are assigning CPT codes 99487, 99488, and 99489 a PFS pr ocedure status indicator of B ( Payments for covered services are always bundled into payment for other serv ices, which are not specified. If RVUs are shown, they are not used for Medica re payment. If these services are covered, payment for them is subsumed by the payment fo r the services to whic h they are bundled (for example, a telephone call from a hospital nurse re garding care of a patient). We will consider these codes, as well as other payment approaches as we continue our multi-year strategy to recognize and support primary care and care management.

I. Payment for Molecular Pathology Services The AMA CPT Editorial Panel has created new CPT codes to replace the codes used to bill for molecular pathology services that will be deleted at the end of CY 2012. The new codes describe distinct molecular pathology tests a nd test methods. CPT divided these molecular pathology codes into Tiers. Tier 1 codes describe common gene-specific and genomic procedures. Tier 2 codes capture reporting for le ss common tests. Each Tier 2 code represents a group of tests that the CPT Editorial Panel beli eves involve similar technical resources and interpretive work. The CPT Ed itorial Panel created 101 new mo lecular pathology CPT codes for CY 2012 and another 14 new molecu lar pathology codes for CY 2013. We stated in our notice for the Clinical Laboratory Fee Schedule (CLFS) Annual Public Meeting held on July 16, 2012 (77 FR 31620) that we were following our regular process to determine the appropriate basis and payment am ounts for new clinical diagnostic laboratory tests, including molecular pathology tests, unde r the CLFS for CY 2013. However, we also336

stated that we understand stakeholders in the molecular pathology community continue to debate whether Medicare should pay for molecular pathology tests under the CLFS or the PFS. Medicare pays for clinical di agnostic laboratory tests through the CLFS and for services that ordinarily require physician work through the PFS. We stated that we believed we would benefit from additional public comments on whether these tests are clinical diag nostic laboratory tests that should be paid under the CLFS or whether they are physicians’ services that should be paid under the PFS. Therefore, we solicited pub lic comment on this i ssue in the CY 2013 PFS proposed rule (77 FR 44782 and 44783), as well as public comment on pricing policies for these tests under the CLFS during the CLFS A nnual Public Meeting process. In the PFS proposed rule, we first discussed and requested public comment on whether these molecular pathology CPT codes describe se rvices that ordinarily require physician work, and then we discussed our proposal to addre ss payment for these CPT codes on the PFS, pending public comment and resolution of the first que stion. The PFS proposal paralleled the CLFS Annual Public Meeting process during which we receive comments and recommendations on the appropriate basis for establishing a payment am ount for the molecular pathology CPT codes as clinical diagnostic laborat ory tests under the CLFS. As detailed in section II.B.1. of this final rule with comment period, Medicare establishes payment under the PFS by setting RVUs for wo rk, practice expense (PE), and malpractice expense for services that ordi narily require physician work. To establish RVUs for physician work, we conduct a clinical review of the relativ e physician work (time by intensity) required for each PFS service. This clini cal review includes the review of RVUs recommended by the American Medical Association/Specialty Soci ety Relative Value Scale Update Committee (AMA RUC) and others. The AMA RUC-recommended work RVUs for a service typically are based in part on results of a survey conducted by the relevant specialty so ciety. CMS establishes PE RVUs under a resource-based PE methodology that considers the cost of direct inputs, as337
well as indirect PE costs. The AMA RUC, through the Practice E xpense Subcommittee, recommends direct PE inputs to CMS, and the relevant specialty soci eties provide pricing information for those direct inputs to CMS. Afte r we determine the appropriate direct PE inputs, the PE methodology is used to develop PE RVUs. Physician work and PE RVUs for each CPT code are constructed to reflect the typical case; that is, they reflect the service as it is most commonly furnished (71 FR 69629). CMS establ ishes resource-based malpractice expense RVUs using weighted specialty-specific malpr actice insurance premium data collected from commercial and physician-owned insurers, last updated for the CY 2010 final rule (74 FR 61758). For most services paid under the PFS, bene ficiary cost-sharing is 20 percent of the fee schedule payment amount. CMS establishes a payment rate for new c linical diagnostic labor atory tests under the CLFS by either crosswalking or gap-filling. Cros swalking is used when a new test code is comparable to an existing test code, multiple exis ting test codes, or a portion of an existing test code on the CLFS. Under this methodology, the new test code is assigned the local fee schedule amounts and the national limitation amount (NLA) of the existing test, with payment made at the lesser of the local fee schedule amount or the NLA. Gap-filling is used when no comparable test exists on the CLFS. In the first year a test is gap-filled, contractor-specific amounts are established for the new test code using the followi ng sources of information: charges for the test and routine discounts to charge s; resources required to perf orm the test; payment amounts determined by other payers; and charges, paym ent amounts, and resources required for other tests that may be comparable or otherwise rele vant. For the second year, the NLA is calculated, which is the median of the carrier-specific amounts. See §414.508. Services paid under the CLFS do not account for any physician work, al though tests paid under the CLFS can involve assessment by a laboratory technician/technologist, a chemist, molecular biologist, or a geneticist – none of which are health care pr ofessional occupations that meet the statutory definition of a338 physician. Although payments can vary geographically due to contractor discretion across locality areas (which are the sa me localities used for the GPCI s under the PFS), payments cannot exceed a NLA, nor are they adjusted once rates ar e determined (apart from inflation updates as required by statute). In th e CY 2008 PFS final rule with comment period, we adopted a prospective reconsideration proces s for new tests paid under the CL FS, allowing a single year for Medicare and stakeholders to revi ew pricing for new tests after a payment is initially established through crosswalking, and in certain circumstances, up to 2 years for Medicare and stakeholders to review pricing for new tests after a payment is initially established th rough gap-filling (72 FR 66275 through 66279, 66401 through 66402). Finally, in almost all circumstances, there is no beneficiary cost-sharing fo r clinical laboratory diagnos tic tests paid on the CLFS. For a handful of clinical laboratory services paid under the CLFS, we allow an additional payment under the PFS for the pr ofessional services of a pathologist when they meet the requirements for a clinical c onsultation service as defined in §415.130(c). The PFS pays for services that ordinarily require the work of a physician and, with regard to pathology services, explicitly pays for both the professional and tech nical component of the se rvices of a pathologist as defined in §415.130(b), including surgical pathology, cytopathology, hematology, certain blood banking services, clinical c onsultations, and inte rpretive clinical la boratory services. Molecular pathology tests are currently billed using combinations of longstanding CPT codes that describe each of the various steps re quired to perform a given test. This billing method is called “stacking” because different “s tacks” of codes are bi lled depending on the components of the furnished test. Currently, all of the stacking codes are paid through the CLFS; and one stacking code, CPT code 83912 (molecular diagnostics; interpreta tion and report), is paid on both the CLFS and the PFS. Payment for the interpretation and report of a molecular pathology test when furnished and billed by a physician is made under the PFS using the professional component (PC, or modifier 26) of CPT code 83912 (83912-26). Payment for the339 interpretation and report of a molecular pathology test when furnished by nonphysician laboratory professional is bundled into paym ent made under the CLFS using CPT code 83912. As we stated in the CY 2013 PFS proposed rule (77 FR 44783), since the creation of new molecular pathology CPT codes, there has been si gnificant debate in the stakeholder community regarding whether these new mol ecular pathology CPT codes descri be physicians’ services that ordinarily require physician work and would be paid under the PFS, or whether they describe clinical diagnostic laboratory tests that would be paid on the CLFS. In the CY 2013 PFS proposed rule (77 FR 44783), we stated that ther e is little agreement on whether the technical component and/or professional co mponent (interpretation and re port) of these services are ordinarily furnished by a physician or a nonphysicia n laboratory professional. Additionally, we stated that some stakeholders have suggested that interpretati on and report by any health care professional is generally not necessary for these services, as the laboratory result reporting is becoming more automated. In the CY 2012 PFS final rule with comment pe riod (76 FR 73190), we stated that for CY 2012, Medicare would continue to use the existi ng stacking codes for th e reporting and payment of these molecular pathology tests, and that the new molecular pathology CPT codes would not be valid for payment for CY 2012. We did this b ecause we were concerned that we did not have sufficient information to know whether the new mo lecular pathology CPT code s describe clinical diagnostic laboratory tests or se rvices that ordinarily require physician work. In the PFS proposed rule, we stated that, for CY 2013, we con tinue to have many of the same concerns that led us not to recognize the 101 molecular pat hology CPT codes for payment for CY 2012. We requested comment on whether the new molecu lar pathology CPT codes describe physicians’ services that should be paid under the PFS, or whether they describe clinical diagnostic laboratory tests that should be paid under the CLFS. We also requested comment on the following more specific questions:340

● Do each of the 101 molecular pathology CPT codes describe services that are ordinarily furnished by a physician?

● Do each of these molecular pathology CPT codes ordinarily require interpretation and written report?

● What is the nature of that interpretation and does it typically require physician work?

● Who furnishes interpretation se rvices and how frequently? In the CY 2013 PFS proposed rule, we also prop osed to price all of the new molecular pathology CPT codes through a single fee schedule, ei ther the CLFS or the PFS. We stated that after meeting with stakeholders and reviewing each CPT code, we believed that there are a discrete number of laboratory me thods used to generate results across molecular pathology tests. For example, two different tests (represented by different CPT codes) may be run using the same testing methodologies, but using diff erent genes. However, there ar e very different processes for establishing payment rates under the PFS and the CL FS. As discussed above, Medicare sets payment under the CLFS by either crosswalki ng or gap-filling and, after the prospective reconsideration process we do not adjust the payment amount fu rther (apart from inflation updates as required by statute). In contrast, Medicare sets payment under the PFS through a set of resource-based methodologies for physician wor k, PE, and malpractice expense, and payment can be reviewed and adjusted as the resources re quired to furnish a service change. We stated that we were concerned that es tablishing different prices for comparable laboratory services across two different payment systems would create a financial incentive to choose one test over another simply because of its f ee schedule placement. We stated that we were also concerned that the differences in prices would become more pronounced over time, as we continue to review the values for physician work and PE inputs on the PFS relative to established CLFS prices. Therefore, largely because of the homogeneity of the laboratory methodologies behind these procedure test codes, we stated that we be lieve that it is appropriate for all new molecular341 pathology CPT codes to be priced on the same fee schedule using the same methodology. We invited public comment on that proposal. As we considered public comment on whether these molecular pathology CPT codes describe services that ordinar ily require physician work, we wanted to ensure that there was a payment mechanism in place to pay for these CPT codes for CY 2013, either on the PFS or the CLFS. We stated that, because we believe th at these molecular pathology CPT codes may be clinical diagnostic laboratory tests payable on the CLFS, comme nts and recommendations from the public on the appropriate basis for establ ishing payment amounts on the CLFS would be discussed and received thr ough the CY 2013 CLFS Annual Public Meeting process. More information on these tests is available on the CMS website at www.cms.hhs.gov/ClinicalLabFeeSched

. As a parallel to determining the appropriat e basis and payment amounts for the molecular pathology CPT codes as clinical diagnostic laboratory tests through the CLFS Annual Public Meeting process, we also proposed payment for these codes under the PFS for CY 2013. In the CY 2013 PFS proposed rule, we stated that the AMA RUC and the College of American Pathologists (CAP) provided CMS with recomm endations for physician work RVUs and PE inputs for most of the molecular pathology CPT codes. We did not have recommendations on physician work RVUs or direct PE inputs for a sma ll number of codes, which represent tests that are patented, and therefore the methodology used to furnish the test is proprietary and was unavailable to the AMA RUC or CMS to support developing appropriate work and direct PE inputs. As we stated in the PFS proposed rule, the AMA RUC-recommended physician workRVUs range from 0.13 to 2.35, with a median work RVU of 0.45. The AMA RUCrecommended physician intra-service times (which, for these codes, equals the total times) range from 7 minutes to 80 minutes, with a median intra- service time of 18 minutes. We noted that the physician work RVU for CPT code 83912-26 and all but one of the other clinical diagnostic342 laboratory services for which CMS recognizes paym ent for clinical interp retation is 0.37. Table 27 lists AMA RUC-recommended physician work RVUs and times, as well as the AMA RUCestimated CY 2013 utilization for these codes. This table contains the AMA RUC’S estimated CY 2013 utilization for all 115 molecular pa thology codes effective for CY 2013 and recommended physician work RVUs and times only for those codes that CAP believes are ordinarily performed by a physician. These va lues are listed for refe rence only and were not used for PFS rate-setting. As we stated in the PFS proposed rule, mol ecular pathology tests can be furnished in laboratories of different types a nd sizes (for example, a large commercial laboratory, academic or research laboratory, typically hospital-based, or potentially, a pathology group practice), and tests may be furnished in small or large batc hes. Also, although th ere are largely homogenous methods across the different tests considered he re, we recognize that for a specific test, the combination of methods may vary across different laboratories. When developing direct PE input recommendations for CMS, CAP and the AMA RUC made assumptions about the typical laboratory setting and batch size to determine the typical direct PE inputs for each service. Given that many of these services are furnished by private laboratories, it was challenging for CAP and the AMA RUC to provide recommendati ons on the typical inputs for many services, and not possible for other services. We poste d the AMA RUC- and CAP-recommended direct PE inputs on the CMS websit e in the files supporting the CY 2013 PFS proposed rule at www.cms.gov/Medicare/Medicare-Fee-for-Servi ce-Payment/PhysicianFeeSched/PFS-FederalRegulation-Notices.html . We stated in the CY 2013 PFS proposed rule (77 FR 44784) that we appreciate all of the effort CAP has made to develop national pricing i nputs; however, we agree with its view that, in many cases, there is no es tablished approach for the specific number and combination of methods involved in executing many of these tests and that the potential pathways for a laboratory or pathology gr oup practice to execute these tests can vary343 considerably. As we discussed in the CY 2013 PFS proposed rule, in addition to recommendations on physician work and direct PE inputs, th e AMA RUC provided CMS with recommended utilization crosswalks for most of the molecular pathology tests. When there are coding changes, the utilization crosswalk tracks Medicare utilization from an existing code to a new code. The existing code utilization figures are drawn from Me dicare Part B claims data. We use utilization crosswalk assumptions to ensure PFS budget neut rality and to create PE RVUs through the PE methodology. The AMA RUC’s recommended crosswalk utilization is presen ted in Table 27 for reference, however, we note that because these services are not payable under the PFS, these values were not used for rate-setting. In th e CY 2013 PFS proposed rule, we stated that we believe that the utilization assumptions for th e technical component of the new CPT codes should be based on the utilization of the corres ponding CPT codes currently billed on the CLFS, and not on the utilization of CPT code 83912-26. As we discussed in the CY 2013 PFS proposed rule, several laboratories provided us with a list of the molecular pathology tests that they perform, and identified the stacki ng codes that are currently used to bill for each test and the new CPT code that would be billed for each test. However, because the same molecular pathology test may be billed using different stacks, and the sa me stack may be billed for different tests, it is not possible to determine which stacks match wh ich new CPT codes unles s the billing entity billed both the new molecular pathology CPT code and the stacking codes. Additionally, if a beneficiary has more than one test on the same date of service and both stacks are billed on the same Medicare claim, it is not possible to determ ine which stacking codes on the claim relate to each test. Furthermore, some tests described by the new CPT codes are currently billed using general “not otherwise classified ” (NOC) pathology CPT codes that capture a range of services and not just the specific molecu lar pathology tests described by th e new CPT codes. We stated that, given these factors, it is difficult to es timate the utilization of the new molecular pathology344 CPT codes based on the Medicare billing of the current stacking and NOC codes. We stated that if we were to finalize payment for molecular pathology tests under the PFS, we did not believe that we could propose national payment rates, because the following questions remained:

● If these services are furnished by a physic ian, what are the appr opriate physician work RVUs and times relative to other similar services?

● Where and how are each of these services typically furnished—for example, what is the typical laboratory se tting and batch size?

● What is the correct projected ut ilization for each of these services? In the CY 2013 PFS proposed rule, we stated th at, given these major areas of uncertainty, if CMS determined that new molecular pathol ogy CPT codes should be paid under the PFS for CY 2013, we would propose to allow the Medicare contractors to price these codes because we do not believe that we have sufficient informa tion to engage in accura te national pricing and because the price of tests can vary locally. As previously discusse d, this proposal was parallel to the CLFS Annual Public Meeting process th rough which we received comments and recommendations on the appropriate basis for establishing a payment amount for these molecular pathology tests as clinical dia gnostic laboratory tests under the CL FS. We stated that if we decided to finalize payment for these new code s under the PFS, we would consider modifying §415.130 as appropriate to provide for payment to a pathologist for molecu lar pathology tests. Finally, we stated that, after reviewing co mments received on the proposals contained within the CY 2013 PFS proposed rule (77 FR 44782 through 44787), and after hearing the discussion at the CLFS Annual Public Meeti ng and reviewing comments and recommendations during the public meeting process, we would de termine the appropriate basis for establishing payment amounts for the new molecular pathology CP T codes. We stated that we would publish our final decision in the CY 2013 PFS final rule with comment pe riod and, at the same time the345 final rule is published, post final payment determ inations for any molecular pathology tests that will be paid under the CLFS. A summary of the comments received on the questions and proposals discussed in the CY 2013 PFS proposed rule, followed by our responses and conclusions are below. We received the following comments in response to our questions on whether these molecular pathology CPT codes describe services that are ordinarily fu rnished by a physician; whether the services require inte rpretation and written report and, if so, who ordinarily furnishes that interpretation and how freque ntly; what is the nature of that interpretation and does it typically require physician work; and the broade r question of whether these codes describe physicians’ services that should be paid under the PFS or if they describe clinical diagnostic laboratory tests that should be paid under the CLFS; as well as our proposal to price all molecular pathology CPT codes through a single fee schedule:
Comment: Many commenters stated that thes e molecular pathology tests are not ordinarily furnished by a physician. These commente rs stated that the se rvices described by the new molecular pathology CPT codes do not requ ire physician involvement , and that the vast majority of tests are performed (both the techni cal component and the in terpretation) without a physician. The American Clinical Laboratory Association (ACLA) commented that a survey of its members showed that in most cases, the te sts are performed, superv ised, and interpreted by nonphysicians, most often doctoral-le vel scientists with expertise in medical genetics. ACLA noted that both Ph.D. geneticists and pathologists can be certified in genetics by an American Board of Medical Specialties. Comments indicate d that some laboratories performing these tests do not employ physicians. In contrast, other commenters noted that the molecular pathology CPT codes were developed as global services, including both professional (phy sician work) and technical components together, and so the CPT codes inhere ntly include physician work. They noted that346 many of the clinical vignette s developed as a part of th e CPT and AMA RUC processes demonstrate the incorporation of the techni cal steps and the professional services by a pathologist associated with each code. There was little agreement among commenter s on whether molecular pathology tests require any interpretation and whether that interp retation is ordinarily furnished by a physician. Several commenters noted that molecular pathol ogy tests can be divided into three groups based on interpretation requirements. The first group includes tests that require interpretation by a physician to generate a beneficiar y-specific result, which, they stat ed, includes tests that utilize fluorescence in situ hybridi zation or immunohistochemistry technology. The second group includes tests that require in terpretation by a nonphysician qualif ied healthcare professional to produce a beneficiary-specific result, which, they stated, includes many of the genetic tests assigned to Tier 1 and Tier 2 CPT codes. The third group incl udes tests that do not require interpretation by either a physician or health ca re professional because th e test system produces the beneficiary-specific result, which, they stat ed, includes multi-analyte assays with algorithmic analyses (MAAAs) and in vitro diagnostic kits for genetic tests that have been assigned Tier 1 and Tier 2 CPT codes. Other commenters noted that each of th e tests represented by the new molecular pathology CPT codes ordinarily requires inte rpretation and report. Several commenters explained that even clearly nega tive results, in most instance s, require an expenditure of resources for interpretation. One commenter e xplained that the result s of these technical procedures require interpretation of the raw data generated, and that a pathologist assumes the responsibility for the generation of these resu lts and performs the wo rk associated with interpreting them, irrespective of whether the be neficiary has a positive or negative result. Additionally, one commenter noted that as mol ecular pathology tests become more and more automated as the field and science evolve, the interpretation and reporting of these tests is347 concurrently becoming more and more complex. There was also little agreement among comment ers as to whether the interpretation and report associated with these molecular pathology tests is ordinarily performed by a physician. Many commenters stated that clin ical molecular diagnostics is a rapidly evolving diagnostic subspecialty that require s both technical and medical knowledge to interpret test results for use in beneficiary care. They explai ned that these molecular pathology tests require review by an expert who is well-versed in th e interpretation of molecular pa thology test results, who has the medical knowledge to place the results in a clinic al context, and who can guide decisions about beneficiary treatment options and care manageme nt. They contended th at selecting the best treatment path for an individual beneficiary’s di sease state is a key facet of molecular pathology and depends upon the pathologist’s clinical exper tise in the disease area. Commenters stated that, with molecular pathology, it is medically necessary for the pathologist to provide the referring physician with clinical insight about how the result s hould be interpreted based on the technique used and on the benefici ary’s history and medical conditi on. They contended that this differs from other laboratory subspecialties where the orde ring physician typically has the expertise to interpret test results. These commen ters stated that interp retation and report of a molecular pathology test is ordi narily furnished by a physician. In contrast, other commenters no ted that, regardless of the nature of the interpretation for a molecular pathology test, doctora l-level geneticists are qualified and credentialed to perform the interpretation. The commenters stated that physician interp retation is not typical. They stated that in some laboratories, physicians may interpret test results when circumstances require a broader clinical review. They went on to note that among 367,370 molecular pathology allowed services with interp retation and report paid by Medicare in 2010, approximately 80 percent of the services did not require a physician interpretation. Commenters who stated that molecular pathology tests ordinarily require the348 interpretation of a physician also stated that the molecular pathology te sts should be paid under the PFS. Generally, these commenters contended th at it is medically necessary for a physician to interpret the molecular pathology test results, guide the beneficiary’s treatment, assess the beneficiary’s progress, and prepare the final repo rt for the beneficiary’s record. As such, the commenter stated molecular pathology, as a fiel d, is fundamentally different from laboratory medicine. They reasoned that complex tests that require physician interpre tation to be clinically meaningful belong on the PFS. Additionally, some commenters stated that these services should be paid under the PFS because the resources involved in furnishi ng molecular pathology tests are changing rapidly. They pointed ou t that only the PFS currently allo ws the valuation of the codes to be continuously reviewed and scrutinize d, taking into account changing technology and increased efficiencies as technology is adopted a nd becomes more widespread. They noted that placing the CPT codes for these molecular pathol ogy tests on the PFS will enable the healthcare system to capture those savings. Finally, some commenters who stated that the molecular pathology tests should be paid under the PFS al so thought that CMS should establish CLFS payment for laboratory interpretation and re port of a molecular pathology test. Commenters who stated that molecular pa thology tests do not ordinarily require the interpretation of a physician also stated that the molecular pathology te sts should be paid under the CLFS. Generally, these commenters contended th at if a service is not ordinarily furnished by a physician, then CMS is precluded from paying for the service under the PFS. They explained that, as stated by the regulation at §415.130(b), allowable physician pathology tests can only be paid if they first meet the threshold criter ia of §415.102(a)(1) (“The se rvices are personally furnished for an individual beneficiary by a physician”) and §415.102(a)(3) (“The services ordinarily require perf ormance by a physician.”) Additionally, some commenters stated that the tests described by the new molecular pathology CPT codes will continue to be performed exactly as they were prior to the coding change and that there is no reason why the tests should not349 continue to be paid under the CLFS. Finally, some commenters who stat ed that the molecular pathology tests should be paid under the CLFS al so suggested that CMS should establish PFS payment for physician interpretation and re port of a molecular pathology test. Finally, in response to our proposal to pri ce all molecular pathology CPT codes through a single fee schedule, most commenters stated that CMS should assess each CPT code independently and include the molecular pathology tests that require physician work on the PFS, and the molecular pathology tests that do not requ ire physician work on the CLFS. However, as stated above, some commenters stated that all the molecular pathology CPT codes include physician work, and should all be placed together on the PFS, while others stated that none of the molecular pathology CPT codes require physician wo rk, and all should be placed together on the CLFS. Finally, as stated above, some commenters suggested that the te sts should be paid under the CLFS with a PFS payment for physician inte rpretation and report of a molecular pathology test whereas others stated that the tests s hould be paid under the PFS with a CLFS payment for laboratory interpretation and repor t of a molecular pathology test. Response: We thank the commenters for their thorough responses to our questions and proposals. After reviewing the comments, we believe that the molecular pathology CPT codes describe clinical diagnostic laboratory tests that should be paid under the CLFS because these services do not ordinarily require interpretation by a physician to produce a meaningful result. While we recognize that these tests may be fu rnished by a physician, after reviewing the public comments and listening to numerous presentati ons by stakeholders throughout the comment period, we are not convinced that all these tests ordinarily require interp retation by a physician. Many commenters stated that ge neticists can provide any ne cessary interpretation for a meaningful test result of a mo lecular pathology test if some in terpretation is required. ACLA noted that both Ph.D. geneticists and pathologists can be certified in genetics by an American Board of Medical Specialties, ev idence that the medical commun ity recognizes geneticists as350 qualified to interpret molecular pathology test results. Commenters described automated laboratory processes and organizatio nal structures that rely on geneticist interpretation when needed, and they presented a claims analysis demonstrating that physician interpretation currently is not typical across molecular pathology services in CY 2010. Further, commenters stated that these molecular pathology te sts are currently payable on the CLFS. We do not agree with some commenters that these codes inherent ly include physician work because they were developed as global services. We have a long-standing policy of dividing a global diagnostic serv ice into a professional and tec hnical component to separately capture the resources involved in the professional work and technical component of the test. We are not convinced that a physicia n must be involved in perfor ming portions of the technical component. We believe that some molecular pathology tests are automa ted and do not require interpretation. Where the la boratory processes are not au tomated, laboratory personnel, including doctoral-level geneti cists, can produce accurate mol ecular pathology test results. Although there might be occasions when a physicia n furnishes some of the technical component of a clinical laboratory test paid under the CLFS, we do not believe that performance by a physician changes the nature of the work. Rather , we believe it would still be appropriate to make payment for the technical work as part of the CLFS payment for the test. One commenter provided a claims analysis demonstrating that physicians are the most common entity to bill CPT code 89312 in the 2009 claims data; that there ar e more individual pathologists submitting claims for molecular pathology services than there are independent la boratories submitting claims for molecular pathology services. We believe this sp eaks to the different busin ess structures in the pathology and laboratory communities. We woul d expect numerous different pathologists working in a hospital-based academic or research la boratory to bill for their professional services interpreting and reporting on a molecular pathology test independently under their NPI or group NPI using CPT code 83912-26. We would expect co mmercial laboratories to bill CPT code351 83912 for interpretation and report by a nonphysicia n laboratory professional, like a doctorallevel geneticist, for a great volume of tests under a single laboratory NPI. We do not believe this analysis of the typical provider supports an assessment of whet her interpretation is ordinarily required for furnishing mol ecular pathology services. Finally, while we considered the differenc es in methodology for pricing under the CLFS versus the PFS, including the ability to apply a budget neutrality adjustment under the PFS, we do not believe that the differences in paymen t methodologies should be a definitive basis for deciding to choose a specific fee schedule. Rath er, the statute requires Medicare to pay using separate methodologies for physicians’ services a nd for clinical diagnost ic laboratory tests. Ultimately, we believe the primary criteri on for determining the appropriate payment methodology is the identific ation of a service as one or the other. Therefore, for CY 2013, we are assigning a PFS procedure status indicator of X (Statutory exclusion. These codes represent an it em or service that is not within the statutory definition of “physicians’ services” for PFS payment purposes (for example, ambulance services). No RVUs are shown for these c odes and no payment may be made under the PFS to the molecular pathology CPT codes listed in Table 27, because payment will be made for these tests under the CLFS. More information on the CLFS determination of the appropriate basis for payment (crosswalk or gap-filling) for thes e tests is available on the CMS website at www.cms.hhs.gov/ClinicalLabFeeSched

. While we do not believe the molecular path ology tests are ordinarily performed by physicians, we do believe that, in some cases, a physician interpretation of a molecular pathology test may be medically necessary to provide a clin ically meaningful, beneficiary-specific result. In order to make PFS payment for that physicia n interpretation, on an interim basis for CY 2013, we have created HCPCS G-code G0452 (m olecular pathology procedure; physician interpretation and report) to de scribe medically necessary interp retation and written report of a352 molecular pathology test, above a nd beyond the report of laboratory results. This professional component-only HCPCS G-code will be considered a “clinical laboratory interpretation service,” which is one of the current categories of PFS pathology services under the definition of physician pathology services at §415.130(b)(4). Section §415.130(b )(4) of the regulations and section 60 of the Claims Processing Manual (I OM 100-04, Ch. 12, section 60.E.) specify certain requirements for billing the professional compon ent of certain clinical laboratory services including that the interpretation (1) must be requested by the patient’ s attending physician, (2) must result in a written narrativ e report included in the patient’ s medical record, and (3) requires the exercise of medical judgment by the consulta nt physician. We note th at a hospital’s standing order policy can be used as a substitute for the individual request by a patient’s attending physician. The current CPT code for interpretation and report, 83912-26, is included on the current list of clinical laboratory interpretation services but will be de leted at the end of CY
2012. We will monitor the utilizati on of this service and collect data on billing patterns to ensure that G0452 is only being used when inte rpretation and report by a physician is medically necessary and is not duplicative of laboratory reporting paid under the CLFS. In the near future, we intend to reassess whether this HCPCS code is necessary, and if so, in conjunction with which molecular pathology tests. A discussion ofthe work and direct PE inputs for HCPCS Gcode G0452 can be found later in this section. We note that physicians can continue to receive payment for the current clinical pathology consultation CPT codes 80500 (Clinical pathology consultation; limited, without review of a patie nt’s history and medi cal records) and 80502 (Clinical pathology consultation; comprehensive, for a complex diagnostic problem, with review of patient’s history and medical records) if the pathology cons ultation services relating to a molecular pathology test meet the definition of those codes. We do not believe it is appropriate to es tablish a HCPCS G-code on the CLFS for the353 interpretation and report of a mo lecular pathology test by a doct oral-level scientist or other appropriately trained nonphysicia n health care professional. The new molecular pathology CPT codes consolidate the services previously reported using the CLFS stacking codes, including the CLFS stacking code for laboratory interpretation and report of a molecular pathology test (CPT code 83912). As such, we believe that payment for the interpretation an d report service would be considered part of the overall CLFS paymen t for the molecular pathology CPT codes. In addition, geneticists and other nonphysician labora tory personnel do not have a Medicare benefit category that allows them to bill and be paid fo r their interpretation services; therefore, they cannot bill or receive PFS payment for HCPCS code G0452. In response to our questions about the a ppropriate physician work RVUs and times, utilization crosswalks, and direct PE inputs for the molecular pa thology services described by the CPT codes, as well as our proposal to contractor price the codes for CY 2013 if we determined that the codes should be paid under the PFS fo r CY 2013, we received the following comments:
Comment: Commenters were not in favor of our proposal to contractor price these CPT codes if we determined that the codes should be paid under the PFS. Commenters urged CMS to establish national payment rates for the ne w molecular pathology CPT codes. Several commenters recommended that we use the AMA RUC- and CAP-recommended RVUs and inputs for these tests. One commenter suggested that contractor pricing is unnecessary to set payment rates for the technical component, since CM S has hospital cost data that can be used to develop payment rates. This commenter went on to strongly urge CMS to provide clear and specific guidance that contractors must work with co st data from constituents in their areas to set appropriate rates for physician services. Commenters stated that they are concerned th at contractor pricing would lack the breadth of input, external scrutiny, and relativity ut ilized in the development of the AMA RUC recommendations. Commenters also believe that contractor pricing would add administrative354 complexities and costs, and that variations in contractor pricing would be disruptive. Also, commenters stated that contractor pricing could result in movement of sites of testing to the highest paying regions in order to maximize Medicare payment for individual services. Furthermore, commenters suggested that the varia tion in the costs of these tests is related to differences in laboratory facilities, equipment, and/or test methodol ogies, and that the variation is not geographically based; therefore, contractor pr icing is not appropriate. Regarding the utilization estimates for th e new molecular pathology CPT codes, the AMA RUC noted that its utiliza tion projections were based on the utilization of CPT code 83912 (molecular diagnostics; interpretation and report) , which includes interpretation on both the physician fee schedule (83912-26) and the clinic al laboratory fee schedule (83912), when interpretation by technical laboratory personnel, such as a geneticist, accompanies performance of the molecular pathology test represented by other “stacking” codes on a claim. The AMA RUC noted that utilization of this service has been growing rapidly and provided updated utilization assumptions based on 2011 Medicare allowed charges for CPT code 83912. These utilization assumptions, and the AMA RUC-reco mmended physician work RVUs and times, for all 115 codes are included in Table 27 for refere nce. However, we note that because these services are not payable under the PFS, thes e values were not us ed for rate-setting. Response: We thank the commenters for their de tailed responses to our questions and proposals. Beginning in CY 2013, the molecular pathology CPT codes will be paid under the CLFS, and HCPCS code G0452 (Molecular diagnostic s; interpretation and report) will be paid under the PFS. Because payment for the molecular pathology CPT codes will be made under the CLFS rather than the PFS, it is not necessary to consider further whet her contractor pricing would be appropriate for the molecular pathology CPT codes under the PFS. We will add a new HCPCS code, G0452, to replace the current CPT c ode that is used to bill under the PFS for interpretation and report of a molecular pathology test (CPT code 83912-26), which is being355

deleted at the end of CY 2012. After review ing the public comments, the AMA RUC and CAP recommendations, and the values of the current and similar services, we believe we have enough information to nationally price HCPCS code G0452 fo r CY 2013. We believe it is appropriate to directly crosswalk the work RVUs, time, utilizat ion, and malpractice risk factor of CPT code 83912-26 to HCPCS code G0452, because we do not believe this coding change reflects a change in the service or in the resources involved in furnishing the service. The current work RVU of 0.37 for CPT code 83912-26 is the same as nearly all the clinical laboratory interpretation service codes. This value is also within the range of AMA RUC- recommended values for the molecular pathology CPT codes— the utilization-weight ed average AMA RUCrecommended work RVU was 0.33, and the medi an AMA RUC-recommended work RVU was 0.45 for the molecular pathology CPT codes. Ba sed on this information, we believe a work RVU of 0.37 appropriately refl ects the work of HCPCS code G0452. Therefore, we are assigning a work RVU of 0.37 and 5 minutes of pr e-service time, 10 minu tes of intra-service time, and 5 minutes of post-service time to HC PCS code G0452 on an interim final basis for CY 2013. We request public comm ent on the interim final va lues for HCPCS code G0452.

TABLE 27: AMA RUC-Recommended Physic ian Work RVUs, Times, and Estimated CY 2013 Utilization for Molecular Pathology CPT Codes (Please note, these values are displayed for reference only and were not used for PFS ratesetting.)

CPT Code Short Descriptor AMA RUC Recommended Work RVU AMA RUC Recommended Physician Time AMA RUC Estimated CY 2013 Utilization 81200* Aspa gene 450 81201 Apc gene full sequence 1.40 60 450 81202 Apc gene known fam variants 0.77 28 90 81203 Apc gene dup/delet variants 0.80 30 400 81205* Bckdhb gene 450 81206 Bcr/abl1 gene major bp 0.37 15 45,729 81207 Bcr/abl1 gene minor bp 0.15 11 3,500 81208 Bcr/abl1 gene other bp 0.46 18 1,000 81209* Blm gene 450 81210 Braf gene 0.37 15 7,000 81211* Brca1&2 seq & com dup/del 4,000356

CPT Code Short Descriptor AMA RUC Recommended Work RVU AMA RUC Recommended Physician Time AMA RUC Estimated CY 2013 Utilization 81212* Brca1&2 185&5385&6174 var 2,000 81213* Brca1&2 uncom dup/del var 4,000 81214* Brca1 full seq & com dup/del 4,000 81215* Brca1 gene known fam variant 1,000 81216* Brca2 gene full sequence 4,000 81217* Brca2 gene known fam variant 600 81220 Cftr gene com variants 0.15 10 7,000 81221 Cftr gene known fam variants 0.40 20 1,000 81222 Cftr gene dup/delet variants 0.22 13 1,300 81223 Cftr gene full sequence 0.40 20 1,000 81224 Cftr gene intron poly t 0.15 10 1,300 81225 Cyp2c19 gene com variants 0.37 13 2,000 81226 Cyp2d6 gene com variants 0.43 15 2,000 81227 Cyp2c9 gene com variants 0.38 14 4,000 81228* Cytogen micrarray copy nmbr 900 81229* Cytogen m array copy no&snp 900 81235 Egfr gene com variants 0.51 20 9,000 81240 F2 gene 0.13 7 31,000 81241 F5 gene 0.13 8 43,000 81242* Fancc gene 450 81243 Fmr1 gene detection 0.37 15 4,000 81244 Fmr1 gene characterization 0.51 20 100 81245 Flt3 gene 0.37 15 6,000 81250* G6pc gene 450 81251* Gba gene 450 81252 Gjb2 gene full sequence 0.65 30 400 81253 Gjb2 gene known fam variants 0.52 28 150 81254 Gjb6 gene com variants 0.40 15 500 81255* Hexa gene 450 81256 Hfe gene 0.13 7 25,000 81257 Hba1/hba2 gene 0.50 20 4,500 81260* Ikbkap gene 450 81261 Igh gene rearrange amp meth 0.52 21 4,500 81262 Igh gene rearrang dir probe 0.61 20 700 81263 Igh vari regional mutation 0.52 23 400 81264 Igk rearrangeabn clonal pop 0.58 22 4,000 81265 Str markers specimen anal 0.40 17 14,000 81266 Str markers spec anal addl 0.41 15 300 81267 Chimerism anal no cell selec 0.45 18 2,000 81268 Chimerism anal w/cell select 0.51 20 300 81270 Jak2 gene 0.15 10 19,000 81275 Kras gene 0.50 20 14,000 81280* Long qt synd gene full seq 450 81281* Long qt synd known fam var 450 81282* Long qt syn gene dup/dlt var 450 81290* Mcoln1 gene 450 81291 Mthfr gene 0.15 10 9,000 81292 Mlh1 gene full seq 1.40 60 1,000357

CPT Code Short Descriptor AMA RUC Recommended Work RVU AMA RUC Recommended Physician Time AMA RUC Estimated CY 2013 Utilization 81293 Mlh1 gene known variants 0.52 28 500 81294 Mlh1 gene dup/delete variant 0.80 30 800 81295 Msh2 gene full seq 1.40 60 1,000 81296 Msh2 gene known variants 0.52 28 500 81297 Msh2 gene dup/delete variant 0.80 30 800 81298 Msh6 gene full seq 0.80 30 450 81299 Msh6 gene known variants 0.52 28 600 81300 Msh6 gene dup/delete variant 0.65 30 500 81301 Microsatellite instability 0.50 20 1,000 81302 Mecp2 gene full seq 0.65 30 200 81303 Mecp2 gene known variant 0.52 28 50 81304 Mecp2 gene dup/delet variant 0.52 28 150 81310 Npm1 gene 0.39 19 4,500 81315 Pml/raralpha com breakpoints 0.37 15 1,000 81316 Pml/raralpha 1 breakpoint 0.22 12 5,000 81317 Pms2 gene full seq analysis 1.40 60 600 81318 Pms2 known familial variants 0.52 28 200 81319 Pms2 gene dup/delet variants 0.80 30 375 81321 Pten gene full sequence 0.80 30 950 81322 Pten gene known fam variant 0.52 28 150 81323 Pten gene dup/delet variant 0.65 30 200 81324* Pmp22 gene dup/delet 450 81325* Pmp22 gene full sequence 450 81326* Pmp22 gene known fam variant 450 81330* Smpd1 gene common variants 450 81331 Snrpn/ube3a gene 0.39 15 250 81332 Serpina1 gene 0.40 15 1,000 81340 Trb@ gene rearrange amplify 0.63 25 4,000 81341 Trb@ gene rearrange dirprobe 0.45 19 1,000 81342 Trg gene rearrangement anal 0.57 25 5,000 81350 Ugt1a1 gene 0.37 15 850 81355 Vkorc1 gene 0.38 15 4,000 81370 Hla i & ii typing lr 0.54 15 14,000 81371 Hla i & ii type verify lr 0.60 30 9,000 81372 Hla i typing complete lr 0.52 15 4,000 81373 Hla i typing 1 locus lr 0.37 15 4,000 81374 Hla i typing 1 antigen lr 0.34 13 13,000 81375 Hla ii typing ag equiv lr 0.60 15 2,000 81376 Hla ii typing 1 locus lr 0.50 15 2,000 81377 Hla ii type 1 ag equiv lr 0.43 15 2,000 81378 Hla i & ii typing hr 0.45 20 2,000 81379 Hla i typing complete hr 0.45 15 1,000 81380 Hla i typing 1 locus hr 0.45 15 1,000 81381 Hla i typing 1 allele hr 0.45 12 1,000 81382 Hla ii typing 1 loc hr 0.45 15 1,000 81383 Hla ii typing 1 allele hr 0.45 15 1,000 81400 Mopath procedure level 1 0.32 10 2,500 81401 Mopath procedure level 2 0.40 15 2,000358

CPT Code Short Descriptor AMA RUC Recommended Work RVU AMA RUC Recommended Physician Time AMA RUC Estimated CY 2013 Utilization 81402 Mopath procedure level 3 0.50 20 2,000 81403 Mopath procedure level 4 0.52 28 2,000 81404 Mopath procedure level 5 0.65 30 2,000 81405 Mopath procedure level 6 0.80 30 1,850 81406 Mopath procedure level 7 1.40 60 1,000 81407 Mopath procedure level 8 1.85 60 1,000 81408 Mopath procedure level 9 2.35 80 1,000 81479* Unlisted molecular pathology 0 *The AMA RUC concluded that these services are not typically performed by a physician at this time. Therefore, they have not been reviewed for physician work or time by the AMA RUC. J. Payment for New Preventive Service HCPCS G-Codes Under section 1861(ddd) of the Act, as amende d by section 4105 of the Affordable Care Act, CMS is authorized to add coverage of “add itional preventive services ” if certain statutory criteria are met as determined through the nati onal coverage determination (NCD) process, including that the service meets all of the following criteria: (1) they must be reasonable and necessary for the prevention or early detection of illness or disability, (2) they must be recommended with a grade of A or B by the Un ited States Preventive Services Task Force (USPSTF), and (3) they must be appropriate for i ndividuals entitled to benefits under Part A or enrolled under Part B. After reviewing th e USPSTF recommendations for the preventive services, conducting evidence reviews, and considering public comments under the NCD process, we determined that the above criteria were met for the servi ces listed in Table 28. Medicare now covers each of th e following preventive services:

● Screening and Behavioral Counseling In terventions in Primary Care to Reduce Alcohol Misuse, effective October 14, 2011;

● Screening for Depression in Adults, effective October 14, 2011;

● Screening for Sexually Transmitted Infecti ons (STIs) and High Intensity Behavioral Counseling (HIBC) to Prevent ST Is, effective November 8, 2011;359

● Intensive Behavioral Therapy for Cardi ovascular Disease, effective November 8, 2011; and

● Intensive Behavioral Therapy for Obesity, effective November 29, 2011. Table 28 lists the HCPCS G-codes created for reporting and payment of these services. The Medicare PFS payment rates for these servi ces are discussed below. The NCD process establishing coverage of these preventive services was not complete at the time of publication of the CY 2012 PFS final rule with comment period, so we could not incl ude interim RVUs for these preventive services in th e addenda to our CY 2012 final rule with comment period. However, we were able to include these HC PCS G-codes with national payment amounts for these services in the CY 2012 PFS national relative value files, which were effective January 1, 2012. From the effective date of each servic e to December 31, 2011, the payment amount for these codes was established by the Medi care Administrative Contractors.
TABLE 28: New Preventive Service HCPCS G-Codes HCPCS Code HCPCS Code Long Descriptor CMS National Coverage Determination (NCD) CMS Change Request (CR) G0442 Annual alcohol misuse screening, 15 minutes Screening and Behavioral Counseling Interventions in Primary Care to Reduce Alcohol Misuse (NCD 210.8) CR7633

G0443 Brief face-to-face behavioral counseling for alcohol misuse, 15 minutes Screening Behavioral Counseling Interventions in Primary Care to Reduce Alcohol Misuse (NCD 210.8) CR7633

G0444 Annual Depression Screening, 15 minutes Screening for Depression in Adults (NCD 210.9) CR7637 G0445 High-intensity behavioral counseling to prevent sexuallytransmitted infections, face-toface, individual, includes: education, skills training, and guidance on how to changesexual behavior; performed semiannually, 30 minutes Screening for Sexually Transmitted infections(STIs) and High- Intensity Behavioral Counseling (HIBC) to prevent STIs (NCD 210.10) CR7610

G0446 Annual, face-to-face intensive Inte nsive Behavioral Therapy for CR7636360
behavioral therapy for cardiovascular disease, individual, 15 minutes Cardiovascular Disease (NCD 210.11)
G0447 Face-to-face behavioral counseling for obesity, 15 minutes Intensive Behavioral Therapy for Obesity (NCD 210.12) CR7641

Two new HCPCS codes, G0442 (Annual alcohol misuse screening, 15 minutes), and G0443 (Brief face-to-face behavior al counseling for alcohol misu se, 15 minutes), were created for the reporting and payment of screening and behavioral counseling interventions in primary care to reduce alcohol misuse. As we explained in the proposed rule, we be lieve that the screeni ng service described by HCPCS code G0442 requires similar physician work as CPT code 99211 (Level 1 office or other outpatient visit, established pa tient). Accordingly, we proposed a work RVU of 0.18 for HCPCS code G0442 for CY 2013, the same work RVU as CPT code 99211. For physician time, we proposed 15 minutes, which is the amount of time specified in the HCPCS code descriptor for G0442. We proposed a malpractice expense cro sswalk to CPT code 99211. The proposed direct PE inputs were reflected in the CY 2013 proposed direct PE input database, available on the CMS website under the downloads fo r the CY 2013 PFS proposed rule at www.cms.gov/PhysicianFeeSched/ . We requested public comment on this CY 2013 proposed value for HCPCS code G0442.
Comment : Commenters supported the propos ed payment for HCPCS code GO442 although a commenter suggested that in the future CMS should use the AMA RUC to assist us in valuing new codes. Response : In response to the suggestion that we rely upon AMA RUC input in valuing new codes, we agree with the co mmenter that the input of the AM A RUC is extremely useful in valuing new codes and in general, we obtain its recommendations in es tablishing the original values for new codes. However, because this new code was added through an NCD effective as361 of October 14, 2011, public commenters, including the AMA RUC, were not able to comment for consideration for CY 2012. We note that si nce this code was valued in CY 2012 based upon CPT code 99211 and the AMA RUC had provided a recommendation on this code previously, the AMA RUC was involved, albeit indirectly, in setting this rate. In addition, there was opportunity for the AMA RUC to provide comment on this code in response to the solicitation for comment on the CY 2013 proposed rule. After consideration of the pub lic comments we received, we are finalizing our CY 2013 proposal to establish a work RVU of 0.18 and a time of 15 minut es for HCPCS code G0442. For malpractice expense, we are finalizing our proposed crosswalk for HCPCS code G0442 to CPT code 99211. We are also finalizing the direct PE inputs as proposed. The direct PE inputs associated with this code are included in the CY 2013 direct PE input database, available on the CMS website under the downloads for the CY 2013 PFS final rule with comment period at www.cms.gov/PhysicianFeeSched/

. Additionally, we note that the PE RVUs included in Addendum B reflect the values that result from the fi nalization of this policy. As we explained in the proposed rule, we be lieve that the behavior al counseling service described by HCPCS code G0443 requires simila r work as CPT code 97803 (Medical nutrition therapy; re-assessment and intervention, indivi dual, face-to-face with the patient, each 15 minutes). Accordingly, we proposed a work RVU of 0.45 for HCPCS code G0443 for CY 2013, the same work RVU as CPT code 97803. For physician time, we proposed 15 minutes, which is the amount of time specified in the HCPCS code descriptor for G0443. Fo r malpractice expense, we proposed a malpractice expense crosswalk to CPT code 97803. The proposed direct PE inputs are reflected in the CY 2013 proposed dire ct PE input database , available on the CMS website under the downloads for the CY 2013 PFS proposed rule at www.cms.gov/PhysicianFeeSched/ . We requested public comment on this CY 2013 proposed value for HCPCS code G0443.362

Comment : Commenters supported the proposed payment for HCPCS code G0443. A commenter inquired why HCPCS code G0443 wa s crosswalked to CPT code 99212 and CPT code 97803 rather than to CPT code 99407 (Smoki ng and tobacco use cessation counseling visit; intensive, greater than 10 minutes). We also received a comment that in the future CMS should use the AMA RUC to assist us in valuing new codes. Response : The commenter was mistaken in stating that HCPCS code G0443 was crosswalked to CPT code 99212; it was crosswalked only to CPT code 97803. In response to the comment about crosswalking this code to CP T 99407, we had considered CPT code 99407 when we initially set the paym ent rate for HCPCS code G0443 and af ter consideration of this comment we continue to believe that the value based upon CPT code 97803, which is a 15-minute counseling code is appropriate. In response to the suggestion that we rely upon AMA RUC input in valuing new codes, we agree with the commen ter that the input of th e AMA RUC is extremely useful in valuing new codes and in general, we obtain its recommendati ons in establishing the original values for new codes. However, because this new code was added through an NCD effective as of October 14, 2011, public commenters , including the AMA RUC, were not able to comment for consideration for CY 2012. We note that since th is code was valued in CY 2012 based upon CPT code 97803 and the AMA RUC ha d provided recommendation on this code previously, the AMA RUC was involved, albeit indir ectly, in setting this ra te. In addition, there was opportunity for the AMA RUC to provide co mment on this code in the solicitation for comment on the CY 2013 proposed rule. After consideration of the public comments that we received, we are finalizing the proposed work RVU of 0.45 and a time of 15 mi nutes for HCPCS code G0443. For malpractice expense, we are finalizing our proposed cro sswalk to for HCPCS code G0443 to CPT code 97803. We are also finalizing the di rect PE inputs as proposed. The direct PE inputs associated with this code are included in the CY 2013 di rect PE input database , available on the CMS363

website under the downloads for the CY 2013 PFS final rule with comment period at www.cms.gov/PhysicianFeeSched/

. Additionally, we note that the PE RVUs included in Addendum B reflect the values th at result from the finalizati on of this policy. HCPCS code
G0444 (Annual Depression Screening, 15 minutes) was created for the reporting and payment of screening for depression in adults. As we explai ned in the proposed rule, we believe that the screening service described by HCPCS code G0444 requires similar physician work as CPT code 99211. Accordingly, we proposed a work R VU of 0.18 for HCPCS code G0444 for CY 2013, the same work RVU as CPT code 99211. For physician time, we proposed 15 minutes, which is the amount of time specified in the HCPCS code descriptor for G0444. Fo r malpractice expense, we proposed a malpractice expense crosswalk to CPT code 99211. The proposed direct PE inputs were reflected in the CY 2013 proposed PE input database, available on the CMS website under the downloads for the CY 2013 PFS proposed rule at www.cms.gov/PhysicianFeeSched/

. We requested public comment on this CY 2013 proposed value for HCPCS code G0444.
Comment : Commenters supported the propos ed payment for HCPCS code GO444 although a commenter suggested that in the future CMS should use the AMA RUC to assist us in valuing new codes. Response : In response to the suggestion that we rely upon AMA RUC input in valuing new codes, we agree with the co mmenter that the input of the AM A RUC is extremely useful in valuing new codes and in general, we obtain its recommendations in es tablishing the original values for new codes. However, because this new code was added through an NCD effective as of October 14, 2011, public commenters, including the AMA RUC, were not able to comment for consideration for CY 2012. We note that si nce this code was valued in 2012 based upon CPT code 99211 and the AMA RUC had provided reco mmendation on this code previously, the AMA RUC was involved, albeit indir ectly, in setting this rate. In addition, there was opportunity for the AMA RUC to provide comment on this c ode in response to the solicitation for comment364 on the CY 2013 proposed rule. After consideration of the pub lic comments we received, we are finalizing the proposed a work RVU of 0.18, and a time of 15 minutes for HCPCS G0444 code. For malpractice expense, we are finalizing our proposed crosswalk fo r HCPCS code G0444 to CPT code 99211. We are also finalizing the direct PE inputs as proposed. The direct PE inputs associated with this code are included in the CY 2013 direct PE input da tabase, available on the CMS website under the downloads for the CY 2013 PFS final rule with comment period at www.cms.gov/PhysicianFeeSched/

. Additionally, we note that the PE RVUs included in Addendum B reflect the values th at result from the finalizati on of this policy. HCPCS code G0445 (high-intensity behavioral counseling to prevent sexually transmitted infections, face-toface, individual, includes: education, skills tr aining, and guidance on how to change sexual behavior, performed semi-annuall y, 30 minutes) was created for the reporting and payment of HIBC to prevent STIs. As we explained in the proposed rule, we believe that the behavioral counseling service described by HCPCS code G0 445 requires similar physician work as CPT code 97803. Accordingly, we proposed a work RVU of 0.45 for HCPCS code G0445 for CY 2013, the same work RVU as CPT code 97803. Fo r physician time, we proposed 30 minutes, which is the amount of time specified in the HC PCS code descriptor for G0445. For malpractice expense, we proposed a malpractice expense cr osswalk to CPT code 97803. The proposed direct PE inputs were reflected in the CY 2013 proposed direct PE input database, available on the CMS website under the downloads for th e CY 2013 PFS CY 2013 proposed rule at www.cms.gov/PhysicianFeeSched/ . We requested public comment on this CY 2013 proposed value for HCPCS code G0445.
Comment : Commenters supported the propos ed payment for HCPCS code GO445 although a commenter suggested that in the future we should use the AMA RUC to assist us in valuing new codes.365
Response : In response to the suggestion thatwe rely upon AMA RUC input in valuing new codes, we agree with the co mmenter that the input of the AM A RUC is extremely useful in valuing new codes and in general, we obtain its recommendations in es tablishing the original values for new codes. However, because this new code was added through an NCD effective as of October 14, 2011, public commenters, including the AMA RUC, were not able to comment for consideration for CY 2012.We note that si nce this code was valued in CY 2012 based upon CPT code 97803 and the AMA RUC had provided r ecommendation on this code previously, the AMA RUC was involved, albeit indir ectly, in setting this rate. In addition, there was opportunity for the AMA RUC to provide comment on this c ode in response to the solicitation for comment on the CY 2013 proposed rule. After consideration of the pub lic comments we received, we are finalizing the proposed a work RVU of 0.45 and a time of 30 minutes for HCPCS code G0445. For malpractice expense, we are finalizing our proposed crosswalk fo r HCPCS code G0445 to CPT code 97803. We are also finalizing the direct PE inputs as proposed. The direct PE inputs associated with this code are included in the CY 2013 direct PE input da tabase, available on the CMS website under the downloads for the CY 2013 PFS final rule with comment period at www.cms.gov/PhysicianFeeSched/

. Additionally, we note that the PE RVUs included in Addendum B reflect the values th at result from the finalizati on of this policy. HCPCS code G0446 (Annual, face-to-face intensive behavioral therapy for cardiov ascular disease, individual, 15 minutes) was created for the reporting and payment of inte nsive behavioral therapy for cardiovascular disease. As we explained in the proposed rule, we believe that the behavioral therapy service described by HCPCS code G0446 requires similar physician work as CPT code 97803. Accordingly, we proposed a work R VU of 0.45 for HCPCS code G0446 for CY 2013, the same work RVU as CPT code 97803. For physician time, we proposed 15 minutes, which is the amount of time specified in the HCPCS code descriptor for G0446. Fo r malpractice expense,366 we proposed a malpractice expense crosswalk to CPT code 97803. The proposed direct PE inputs were reflected in the CY 2013 proposed di rect PE input database, available on the CMS website under the downloads for the CY 2013 PFS proposed rule at www.cms.gov/PhysicianFeeSched/ . We requested public comment on this CY 2013 proposed value for HCPCS code G0446.
Comment : Commenters supported the proposed payment for HCPCS code GO446. In addition, a commenter urged a change in our policy to allow billing of multip le units of this code in one encounter. We also received a comme nt that in the future CMS should use the AMA RUC to assist us in valuing new codes. Response : In response to the suggestion regard ing billing multiple units of HCPCS code G0446, this proposal deals only with the payment rate for this service, not coverage issues. We note that the NCD is clear that only one visit annually is covere d. In response to the suggestion that we rely upon AMA RUC input in valuing new codes, we agree with the commenter that the input of the AMA RUC is extremely useful in va luing new codes and in general, we obtain its recommendations in establishing the original valu es for new codes. However, because this new code was added through an NCD effective as of October 14, 2011, public commenters, including the AMA RUC, were not able to comment for c onsideration for CY 2012. We note that since this code was valued based upon CPT code 97803 and AMA RUC had provided recommendation on this code pr eviously, the AMA RUC was invol ved, albeit indirectly, in setting this rate. In addition, there was oppor tunity for the AMA RUC to provide comment on this code in response to the solicitati on for comment on the CY 2013 proposed rule. Based upon the comments we received, we ar e finalizing the proposed rate for HCPCS code G0446. It will be valued with a work RVU of 0.45, and with a ti me of 15 minutes. For malpractice expense, we are finalizing our proposed crosswalk for HCPCS code G0446 to CPT code 97803. We are also finalizing the direct PE inputs as proposed. The direct PE inputs367

associated with this code are included in the CY 2013 direct PE input database, available on the CMS website under the downloads for the CY 2013 PFS final rule with comment period at www.cms.gov/PhysicianFeeSched/

. Additionally, we note that the PE RVUs included in Addendum B reflect the values th at result from the finalization of this policy. HCPCS G0447 (Face-to-face behavioral counsel ing for obesity, 15 minutes) was created for the reporting and payment of intensive behavioral therapy for obesi ty. As we explained in the proposed rule, we believe that the behavioral counseling servic e described by HCPCS code G0447 requires similar physician work to CPT code 97803. Accordingly, we proposed a work RVU of 0.45 for HCPCS code G0447 for CY 2013, the same work RVU as CPT code 97803. For physician time, we proposed 15 minutes, which is the amount of time specified in the HCPCS code descriptor for G0447. For malpractice expense, we proposed a malpractice expense crosswalk to CPT code 97803. The proposed direct PE inputs were reflect ed in the CY 2013 direct PE input database, available on the CMS website under the downloa ds for the CY 2013 PFS proposed rule at www.cms.gov/PhysicianFeeSched/ . We requested public comment on this CY 2013 proposed value for HCPCS code G0447.
Comment : Commenters supported the proposed payment for HCPCS code GO447. In addition, a commenter urged a change in our policy to allow billing of multip le units of this code in one encounter. We also received a comme nt that in the future CMS should use the AMA RUC to assist us in valuing new codes. Response : With regard to billing for multiple units of HCPCS code G0447 in the same encounter, this proposal addresses only the payment rate for, not the coverage of this code. We note that the NCD establishes that coverage is for one visit per day of servi ce. In response to the suggestion that we rely upon AM A RUC input in valuing new codes, we agree with the commenter that the input of the AMA RUC is ex tremely useful in valuing new codes and in general, we obtain its recommenda tions in establishing the original values for new codes.368
However, because this new code was added th rough an NCD effective as of October 14, 2011, public commenters, including the AMA RUC, were not able to comment for consideration for CY 2012. We note that since this code was valued in CY 2012 based upon CPT code 97803 and AMA RUC had provided recommendation on th is code previously, the AMA RUC was involved, albeit indirectly, in se tting this rate. In addition, there was opportunity for the AMA RUC to provide comment on this code in the re sponse to the so licitation for comment on the CY 2013 proposed rule. After the consideration of the public comments we received, we are finalizing the proposed work RVU of 0.45 and a time of 15 minut es for HCPCS G0447 code. For malpractice expense, we are finalizing our proposal to crosswalk HCPCS code G0447 to CPT code 97803. We are also finalizing the direct PE inputs as proposed. The direct PE inputs associated with this code are included in the CY 2013 direct PE input database, available on the CMS website under the downloads for the CY 2013 PFS final rule with comment period at http://www.cms.gov/PhysicianFeeSched/

. Additionally, we note that the PE RVUs included in Addendum B reflect the values that result from the fi nalization of this policy. K. Certified Registered Nurse Anesthetists Scope of Benefit The benefit category for services furnished by a certified registered nurse anesthetist (CRNA) was added in section 1861(s)(11) of the Act by section 9320 of the Omnibus Budget Reconciliation Act (OBRA) of 1986. Since th is benefit was impleme nted on January 1, 1989, CRNAs have been eligible to bill Medicare direct ly for services within this benefit category. Section 1861(bb)(2) of the Act defines a CRNA as “a certified registered nurse anesthetist licensed by the State who meets such education, training, and other requirements relating to anesthesia services and related care as the S ecretary may prescribe. In prescribing such requirements the Secretary may use the same re quirements as those established by a national organization for the certification of nurse anesthetists.”369 Section 410.69(b) defines a CRNA as a regist ered nurse who: (1) is licensed as a registered professional nurse by the State in wh ich the nurse practices; (2) meets any licensure requirements the State imposes with respect to nonphysician anesthetists; (3) has graduated from a nurse anesthesia educational program that meets the standard s of the Council on Accreditation of Nurse Anesthesia Programs, or such other accreditation organization as may be designated by the Secretary; and (4) meets one of the follo wing criteria: (i) ha s passed a certification examination of the Council on Certification of Nu rse Anesthetists, the Co uncil on Recertification of Nurse Anesthetists, or any other certification organization that may be designated by the Secretary; or (ii) is a graduate of a program described in paragraph (3) of this definition and within 24 months after that graduation meets th e requirements of paragraph (4)(i) of this definition. Section 1861(bb)(1) of the Act defines services of a CRNA as “anesthesia services and related care furnished by a certified registered nurse anesth etist (as defined in paragraph (2)) which the nurse anesthetist is legally authorized to perform as such by the State in which the services are furnished.” CRNAs are paid at the same rate as physicians for furnishing such services to Medicare beneficiar ies. Payment for services furnished by CRNAs only differs from physicians in that payment to CRNAs is made only on an assignment-related basis (§414.60) and supervision requirements appl y in certain circumstances. At the time that the Medicare benefit for CRNA services was established, anesthesia practice, for anesthesiologists and CRNAs, largely occurred in the surgical setting and services other than anesthesia (medical and surgical) were furnished in the immediate pre- and postsurgery timeframe. The scope of “anesthesia serv ices and related care” as delineated in section 1861(bb)(1) of the Act reflect ed that practice. As anesthesiologists and CRNAs have moved into other practice settings, questions have arisen re garding what services are encompassed under the benefit category’s characterizati on of “anesthesia and related care.” As an example, some370 CRNAs now offer chronic pain management serv ices that are separate and distinct from a surgical procedure. We recently received additional information about upcoming changes to CRNA curricula to include specific training regard ing chronic pain management services. Such changes in CRNA practice have prom pted questions as to whether these services fall within the scope of section 1861(bb)(1) of the Act. As we noted in the CY 2013 proposed rule (77 FR 44788), Medicare Administrative Contractors (MACs) have reached different conc lusions as to whether the statutory benefit category description of “anesthesia services and related care” encompasses the chronic pain management services furnished by CRNAs. The scope of the benefit ca tegory determines the scope of services for which a physician, practitione r, or supplier may receive Medicare payment. In order for the specific services to be paid by Medicare, the services must be reasonable and necessary for treatment of the patient’s illness or injury. To address what is included in the benef it category for CRNAs in the CY 2013 proposed rule, we assessed our current regulations and su bregulatory guidance, and determined that the existing guidance does not specifica lly address whether chronic pain management is included in the CRNA benefit. In the In ternet Only Manual (Pub 100-04 , Ch 12, Sec 140.4.3), we discuss the medical or surgical services that fall under the “related care” language stating: “These may include the insertion of Swan Ganz catheters, central venous pressure lines, pain management, emergency intubation, and the pre-anesthetic ex amination and evaluation of a patient who does not undergo surgery.” Some have interpreted the reference to “pain management” in this language as authorizing direct payment to CRNAs for chronic pain management services, while others have taken the view that the services highlighted in the manual language are services furnished in the perioperative setting and refer onl y to acute pain management associated with the surgical procedure.371 After assessing in the propos ed rule (see 77 FR 44788) the information available to us, we concluded that chronic pain management wa s an evolving field, and we recognized that certain states have determined that the scope of practice for a CRNA should include chronic pain management to meet health care needs of their re sidents and ensure their health and safety. We also found that several states, including California, Colorado, Mi ssouri, Nevada, South Carolina, and Virginia, were debating whethe r to include pain management in the CRNA scope of practice. After determining that the scope of practice fo r CRNAs was evolving and that there was not a clear answer on pain management specifically, we proposed to revise our regulations at §410.69(b) to define the statutory benefit for CRNA services with deference to state scope of practice laws. Specifically, we proposed to add the following language: “Anesthesia and related care includes medical and surgical services that are related to anesthesia and that a CRNA is legally authorized to perform by the state in wh ich the services are furnished.” We explained that this proposed definition woul d set a Medicare standard for the services that can be furnished and billed by CRNAs while allowing appropriate flexibility to meet the unique needs of each state. The proposal also dovetail ed with the language in secti on 1861(bb)(1) of the Act requiring the state’s legal authorization to furnish CR NA services as a key component of the CRNA benefit category. Finally, we st ated that the proposed benef it category definition was also consistent with our policy to rec ognize state scope of practice as de fining the services that can be furnished and billed by other NPPs. The following is a summary of the comments we received regarding the proposal to revise our regulations at §410.69(b) to define the statutory desc ription of CRNA services. We received a significant volume of comments fr om specialty groups, individual physicians, and practitioners, including CRNAs and Student Registered Nurse Anesthetists (SRNAs), educational program directors, and patients, who strongly sup ported defining the CRNA benefit broadly. There were also many commenters who strongly opposed th is proposal, including372 specialty groups, individual physicians and practiti oners, patients, educati onal program directors, and a patient advocacy group.
Comment : Among those supporting the concept of our proposal, we received several comments suggesting alternative regulatory definiti ons of the statutory benefit category phrase, “anesthesia and related care.” Many comment ers said that CMS should allow CRNAs to practice to the full extent of st ate law. Some commenters provi ded alternative definitions for anesthesia and related care. These included “medi cal and surgical services that are related to anesthesia or that a CRNA is legally authorized to perform by the State in which the services are furnished,” “medical and surgical services that are related to anesthesia , including chronic pain management services unless specif ically prohibited or outside th e scope of the CRNA's license to practice," “medical services, surgical services, and chronic and acute pain management services that a CRNA is legally authorized to perform by the State in which the services are furnished,” "medical and surgical services a CRNA is legally authorized to perfor m by the state in which services are furnished and which are done to pr ovide surgical or obste trical anesthesia or alleviate post-operative or chronic pain," and “med ical and surgical services that are related to anesthesia, including chronic pain management, unless a CRNA is legally prohibited to perform by the State in which the services are furnished." One commenter made th e point that Medicare should use a definition that include d coverage of advanced practice registered nurse services that are within the scope of practice under applicable state law, ju st as physicians’ services are now covered. Other commenters referenced preamble text in our 1992 final rule, which states "we describe related care services as... pain management services, a nd other services not directly connected with the anesthesia service or associat ed with the surgical se rvice" and noted that historically, related care services have been recognized as a differe nt class of anesthesia services, which may or may not be related to anesthesia . One commenter request ed that we define373 “related care” separately from anes thesia, as "medical and surgical services not directly related to anesthesia, including but not limite d to the insertion of arterial lines, central venous pressure lines, and Swan Ganz catheters, acute and chro nic pain management and emergency intubation, and that a CRNA is legally authorized to pe rform by the state in which the services are furnished." Some commenters pointed to Me dicare policies allowing othe r advanced practice nurses such as nurse practitioners or c linical nurse specialists to furnish and bill for physicians’ services as support for recognizing a simila r interpretation of the scope of CRNA practice. Commenters stated that CRNAs should be able to practice to the full extent of state law. Commenters cited the Institute of Medicine repor t [The Future of Nursing: L eading Change, Advancing Health, 11/17/10] that stated that nurses s hould be able to practice to th e full extent of their education and training. Our proposal to define related car e as “related to anesthesia” resulted in various views as to whether this would include pain management and other services. Some st ated that it restricted the benefit category, but others be lieved that it expanded it. The commenters further stated that there are no chronic, long-term, anesthesia relate d services that occur out side the operating room or recovery room where the practice of anesthesia is appropriate. Others stated that chronic pain management services are outside the scope of pe rioperative related care de fined in the Act, and that chronic pain is not related to anesthesia. Response : After reviewing comments regarding our proposed definition of “anesthesia and related care,” we believe that the proposed regulation language statin g that “Anesthesia and related care includes medical and su rgical services that are relate d to anesthesia and that a CRNA is legally authorized to perform by the state in which the services ar e furnished” would not accomplish our goals. It would require updating as health care evolves and as CRNA practice changes. It also would continue Medicare’ s differentiation between CRNAs and other NPPs374

because the Medicare benefit fo r other NPPs relies more heavily on the NPPs’ authority under state law. In addition, we agree with commenter s that the primary responsibility for establishing the scope of services CRNAs are sufficiently trained and, thus, s hould be authorized to furnish, resides with the states. We ag ree with commenters that, as CRNA training and practice evolve, the state scope of practice laws for CRNAs se rve as a reasonable proxy for what constitutes “anesthesia and related care.” Therefore, we are revising §410.69(b) to define the statutory benefit category for CRNAs, which is specified as “anesthesia and related care,” as “those services that a certified registered nurse anesthetist is legally authorized to perform in the state in which the services are furnished.” By this ac tion, we are defining the Medicare benefit category for CRNAs as including any services the CRNA is permitted to furnish under their state scope of practice. In addition, this acti on results in CRNAs being treate d similarly to other advanced practice nurses for Medicare purposes. This policy is consistent with the Institute of Medicine’s recommendation that Medicare cover services provided by advanced prac tice nurses to the full extent of their state scope of practice. CMS will continue to monitor stat e scope of practice laws for CRNAs to ensure that they do not expand beyond the appropriate bounds of “anesthesia and related care” for purposes of the Medicare program.
Comment : Some commenters suggest ed that the proposal expa nds the scope of practice of CRNAs into the practice of medicine, and th at the proposal undermines medical education, the practice of medicine, and the pain medicine specialty by equating nurses with physicians. Commenters further stated that such proposals, which lead to privileging and reimbursement for nonphysician practitioners that are identical to that of physicians, decrease the incentives to complete the rigorous training involved in medical school. Others stated that the proposal would interfere with the authority of stat es to regulate scope of practice. Response : We acknowledge the concerns of the physician community; however, the intent of the proposal is not to undermine medical education, the practice of medicine, or the pain375 medicine specialty, but to estab lish parity between the scope of the Medicare benefit category for CRNAs and the CRNA authority to practice under state law. This proposal does not address payment rates for anesthesiologists or CRNAs. The statutory provisions that establish payment rates for CRNAs at the same rate as anesthes iologists are relatively longstanding. Our proposal in no way is intended to interfere with the authorit y of individual states; rather, it largely defers to individual states to determine the scope of practice for CRNAs. We believe that using state scope of practice law as a proxy for services en compassed in the statutory benefit language “anesthesia and related care” is preferable to choosing among individu al interpretations of whether particular services fall within the scope of “anesthesia and relate d care.” Moreover, we believe states are in an ideal position to gauge the status of , and respond to changes in, CRNA training and practice over time that might warrant changes in the definition of the scope of “anesthesia services and relate d care” for purposes of the Me dicare program. As such, we believe it is appropriate to look to state scope of practice law as a proxy for the scope of the CRNA benefit.
Comment : Many commenters addressed the extent to which the standards for nurse anesthesia curricula and the c ontent of nurse anesthesia educ ational programs do or do not prepare CRNAs to practice outside the periopera tive setting, and specifically, to furnish chronic pain services. We received detailed comments regarding the necessary components of chronic pain services and conflicting information abou t whether CRNAs are trained or licensed to furnish such services. We received thorough descrip tions of the skills required to furnish chronic pain services and the necessity of medical educa tion to prepare one to furnish such services. Commenters also provided information about th e inherent dangers involved in chronic pain services, the manner in which technical skills in chronic pain procedures are obtained, and the ways in which chronic pain services are or ar e not similar to other procedures performed by CRNAs in the perioperative setting and for labor epidurals. We recei ved many comments from376 the physician community with concerns about the po ssibility of the furnishi ng of procedures that are not indicated due to lack of medical knowledge required to screen out patients who are not appropriate candidates for procedures. Some commenters pointed to the long pe riod of time during which CRNAs have furnished chronic pain services with no docum ented differences in patient outcomes, while others expressed concern about negative outcomes observed from inadequately trained providers. Descriptions were also provided regarding lawsuits at the state level that have debated whether CRNAs are qualified to furnish chronic pain serv ices, the importance of medical regulation in protecting patients who may not be able to differentiate between di fferent types of providers, and the role of the medical education process in ensuring competency of physicians. Other commenters opined that it is the responsibility of the individual provider to assure his or her competency for any and all procedures furnished. Response : We acknowledge the varying perspectives about the educatio n and training of CRNAs to furnish chronic pain management servi ces as well as differences of opinion regarding the safety of chronic pain management services furnished by CRNAs. We are unable, at this time, to assess the appropriateness of the CRNA tr aining relating to specific procedures. We are also unaware of any data regarding the safety of chronic pain management services when furnished by different types of professionals. Howe ver, we expect that st ates take into account all appropriate practitioner training and certifications , as well as the safety of their citizens, when making decisions about the scope of services CRNAs are authorized to furnish and providing licenses to individua l practitioners in their jurisdictions. We note that we did not address the servic es that CRNAs are tr ained and qualified to furnish in our proposal or in this final rule with comment period. Our proposal and this final rule merely define what services are included in th e scope of the Medicare benefit established in section 1861(bb)(1) of the Act. The definition that we are adopting uses the state scope of377 practice as a proxy for what the term “anesthesia and related care” in section 1861(bb)(1) of the Act means and thus leaves decisions about what se rvices constitute anesthesia and related care to be resolved by the state. This appropriately recognizes the actions of state bodies formed specifically to address the issue of what constitutes the scope of practice for a CRNA. We believe that determining whether or not CRNAs are adequately trained and can safely furnish chronic pain management is an appropriate decision for state bodies . This proposal is consistent with the Institute of Medicine ’s report on advanced practice nursing, which recommends that Medicare should “include coverage of advanced pr actice registered nurse se rvices that are within the scope of practice under applicab le state law, just as physicians’ services are now covered." We agree with commenters that it also is th e responsibility of i ndividual practitioners (physicians and CRNAs) to ensure that they are adequately trained and qualified to furnish any and all procedures that they furnish.
Comment : We received comments about the cost of CRNA services relative to those furnished by anesthesiologists. Commenters stat ed that chronic pain management services are less costly than surgical interventions, and that the services of CRNAs are more cost-effective for the Medicare program. Others stated that allowing CRNAs to furnish these services could increase spending due to the prov ision of inappropriate services and the comp lications that could result from procedures furnished by CRN As who are not adequately trained. Response : We do not have sufficient evidence to determine that chronic pain management interventions reduce the need for su rgical interventions, or that there would be increased provision of inappropriate services and complications under a definition of the Medicare benefit category that defines “anesthesia and related care” as services a CRNA is authorized to furnish in his or her state. Spe nding for services under Medi care is not a factor in determining whether the statutory benefit encompasses particular services. However, we would note that CRNAs are generally paid at the same ra te as anesthesiologists so there are no direct378 cost savings when services are furnished by CRNAs.
Comment : We received comments regarding special concerns about access in rural areas. Commenters stated that CRNAs help patients avoid traveling l ong distances and long waits for appointments by having local provide rs available. Furthermore, commenters noted that as the population ages, the demand for chronic pain mana gement services will increase. Commenters stated that decreased access to chronic pain ma nagement services (which would result if CRNAs are not permitted to furnish and bill for these se rvices) would result in more institutionalization, reduced quality of life, longer wait times, and increased costs. Ot hers stated that chronic pain management services are not emergent care services ; that chronic pain mana gement is a specialty that should be furnished by those with a high degree of sub-specialty training, and that pain physicians can be spread out over large areas since only a small minority of patients need procedural care. Some commenters cited a shor tage of pain management physicians qualified to treat chronic pain, others stated that there is no shortage of such provi ders, while still others stated that the proposal may increase access, but at the expense of having unqualified providers. Finally, some commenters stated that procedur es furnished improperly pose a greater danger than a lack of available services. Response : While assuring access for beneficiaries in rural areas is a priority for Medicare, we do not have sufficient data to evaluate th e presence or degree of problems of access to chronic pain management services in rural area s. We also do not have evidence that CRNAs have furnished chronic pain management servic es in quantities sufficient to improve any access problems in rural areas. We further lack suffici ent data to determine whether beneficiaries who lack access to a CRNA care are more likely to suffer the negative outcomes cited by commenters. This lack of information does not deter us taking action to define the statutory benefit as it is not necessary to conclude that beneficiaries will suffer negative consequences to prompt us to act. Rather we are issuing th is regulation based upon the factors we described379

above.
Comment : We received comments regarding those se rvices included in the definition of anesthesia and related care, as well as services “related to anesthesia.” Some commenters stated that chronic pain management services are not dir ectly “related to anesth esia” but still constitute “related care”. Other comment ers stated that CMS has already acknowledged in early preamble language that CRNAs may furnish services not di rectly related to anesthesia. Still other commenters stated that chronic pain services ar e not related to anesthesia in any way. One commenter suggested that CMS ha s already differentiated between anesthesia related acute pain and interventional chronic pain ba sed on the creation of different specialty codes for anesthesia and chronic pain. One commen ter requested that CMS make a regulatory change to allow CRNAs to order diagnostic tests in order to effectively provide chronic pain management services. Response: We believe that the statutory intent was to include services not directly related to the peri-anesthetic setting in the CRNA benefit category. We believe that relying on state scope of practice to define the services encompasse d in anesthesia and related care is preferable to choosing among conflicting definitions of “anesth esia and related care” or listing the specific services that fall within that benefit category. Ra ther, we believe states are in a better position to gauge the status of, and respond to changes in, CRNA training and practice over time that might warrant changes in the definition of the scope of “anesthesia services and related care” for purposes of the Medicare program. As such, we belie ve it is appropriate to look to state scope of practice law as a proxy for the sc ope of the CRNA benefit.
Comment : Several commenters expressed concer n with the wording of our proposal; specifically, that the term “related to anesthesia” was unclear a nd subject to interpretation. States do not typically define services “related to anesthesia” in thei r state scope of practice acts. Response : We agree with commenters that the wo rding of the proposal was unclear. In380 response to these and other commenter concerns, we are adopting a modification of our proposal to rely on state scope of practi ce to define the services encompassed in “anesthesia and related care” under section 1861(bb )(1) of the Act.
Comment : One commenter requested that we provi de clarification for the payment of CRNA services furnished; specifically, which medical and/or surgical CRNA services are eligible for cost-based reimbursement (for CR NA pass-through payments or Method II billing for Critical Access Hospitals). Response : We will be modifying the Internet Only Manual to reflect the change we are making in this final rule with comment period. The request for the list of services that are eligible for cost-based reimbursement is beyond the scope of this rule, as it pertains to hospital billing. We anticipate this matter will be addr essed separately in a forthcoming transmittal. Comment: Commenters requested that CMS inst ruct Medicare contractors to review prior denials of claims for CRNA servi ces prior to any final rule dete rmination of the scope of the CRNA Medicare benefit category. Response: This definition of the Medicare benefit for CRNAs will be effective for services furnished on or after January 1, 2013. It does not apply to servic es furnished prior to this point so we will not be instructing cont ractors to review prior denials of claims. After consideration of all comments, we are finalizing our proposal with modification to revise our regulations at §410.69(b) to define “Anesthesia and re lated care” under the statutory benefit for CRNA services as follows: “Anesthesi a and related care means those services that a certified registered nurse anesthetist is legally authorized to perform in the state in which the services are furnished.” We will continue to mo nitor the state scope of practice laws for CRNAs in order to insure that the use of state scope of practice as a proxy to defi ne “anesthesia services and related care” is consistent with th e goals and needs of Medicare program. L. Ordering of Portable X-Ray Services381 Portable x-ray suppliers furnis h diagnostic imaging services at a beneficiary’s location. These services are most often furnished in re sidences, including private homes and alternative living facilities (for example, nursing homes) ra ther than in a traditional clinical setting (for example, a doctor’s office or hospital). The supplier transports mobile diagnostic imaging equipment to the beneficiary’s location, sets up th e equipment, and administers the test onsite. The supplier may interpret the results itself or it may furnish the results to an outside physician for interpretation. Portable x-ray services may avoid the need for expensive ambulance transport of frail beneficiaries to a ra diology facility or hospital. Our Medicare Conditions for Coverage (CfC) regulations require that “portable x-ray examinations are performed only on the order of a doctor of medicine (MD) or doctor of osteopathy (DO) licensed to practice in the st ate...” (§486.106(a)). With the exception of portable x-ray services, Medicare payment regulations at §410.32(a) allow physicians, as defined in section 1861(r) of the Act, and certain nonphy sician practitioners at §410.32(a)(2) to order diagnostic x-ray tests, diagnostic laboratory tests, and other di agnostic tests as long as those nonphysician practitioners are operat ing within the scope of thei r authority under state law and within the scope of thei r Medicare statutory benefit. P hysicians other than an MD or DO recognized to order diagnostic tests under §410. 32(a) include the following limited-license practitioners: doctor of optometr y, doctor of dental surgery and doctor of dental medicine, and doctor of podiatric medicine. Nonphysician practi tioners authorized to order diagnostic tests under §410.32(a)(2) include nurse pr actitioners, physician assistants , clinical nurs e specialists, certified nurse-midwives, clini cal psychologists, and clinical social workers. Nonphysician practitioners have become an increasingly importa nt component of clinical care, and we believe that delivery systems should take full advantage of all member s of a healthcare team, including nonphysician practitioners.382 Although current Medicare regula tions limit the ordering of por table x-ray services to a MD or a DO, the Office of the Inspector Gene ral (OIG) in its December 2011 report entitled Questionable Billing Patterns of Portable X-Ray Suppliers (OEI-12-10-00190) found that Medicare was paying for portable x-ray services ordered by physicians other than MDs and DOs, including podiatrists and chiropr actors, and by nonphysician practiti oners. We issued a special education article on Januar y 20, 2012, through the Medicare Learning Network (MLN) “Important Reminder for Providers and Suppliers Who Provide Services and Items Ordered or Referred by Other Providers and Suppliers, ” reiterating our current po licy that portable x-ray services can only be ordered by a MD or DO. The article is available at http://www.cms.gov/MLNMatters Articles/downloads/SE1201.pdf on the CMS website. Since the publication of the above mentioned article, seve ral stakeholders have told us that members of the healthcare community fail to distinguish or dering for portable x-ray services from ordering for other diagnostic services where our general policy is to allow nonphysician practitioners and physicians other than MDs and DOs to order diagnos tic tests within the scope of their authority under state law and their Medica re statutory benefit. They report finding the different requirements confusing. We proposed to revise our current regulat ions, which limit ordering of portable x-ray services to only a MD or DO, to allow ot her physicians and nonphysicia n practitioners acting within the scope of th eir Medicare benefit and state law to order portable x-ray services. Specifically, we proposed revisions to the CfC at §486.106(a) and §486.106(b) to permit portable x-ray services to be ordered by a physician or nonphysician practitioner in accordance with the ordering policies for other dia gnostic services under §410.32(a). This proposed change would allow a MD or DO, as well as a nurse pr actitioner, clinical nurse specialist, physician assistant, certifie d nurse-midwife, doctor of optometry, doctor of dental surgery and doctor of dent al medicine, doctor of podiatric medicine, clinical psychologist,383

and clinical social worker to or der portable x-ra y services within the sc ope of their authority under state law and the scope of their Medicare benefit. Although all of these physicians and nonphysician practitioners are authorized to or der diagnostic services in accordance with §410.32(a), their Medicare benefit an d state scope of practice delimits the services that they can furnish. For example, the state scope of practice for clinical psychologists typically is limited to the diagnosis and treatment of mental health di sorders and related servi ces. The scope of the Medicare benefit for clin ical social workers under 1861(hh) of th e Act limits their ability to order diagnostic tests to mental health related tests.
Comment : The majority of commenters support ed allowing additional nonphysician and limited-license practitioners to order portable x-ra y services. The commenters stated that this proposal is consistent with the in creasing role for practitioners ot her than MDs or DOs in health care delivery today, with nonphysician and limited lic ense practitioner training and practice, with staffing decisions for care furnished in nursing ho mes and other home care settings, and with the scope of practice for various pract itioners under state law. Response : We thank the commenters for their support and agree with these comments. As we stated in the CY 2013 PFS proposed rule , we believe nonphysicia n practitioners have become an increasingly important component of clini cal care, and we believe that delivery systems should take full advantage of all me mbers of a healthcare team, including nonphysician practitioners. Allowing limited- license and nonphysician practiti oners to order portable x-ray services within the scope of their practice wi ll enhance the role of those practitioners.
Comment : Some commenters either questione d or opposed the ability of certain nonphysician or limited-license practitioners to or der portable x-ray services. The commenters stated that by including clini cal psychologists and clin ical social workers, our proposal was too broad as these nonphysician practitioners do not ha ve the appropriate edu cation or training to order portable x-ray services. In addition, they noted that the or dering of portable x-ray services384 is not within clinical psychologist s’ and clinical social workers’ state scopes of practice. One commenter stated that the orde ring authority for portable x-ray services should only be expanded to physician assistants, nurse practitioners, and doct ors of podiatric medicine , stating that there is no convincing or clinically suppor table rationale for other pract itioners identified in §410.32(a), including certified nurse- midwives, doctors of optometry, doctors of dental surgery and doctors of dental medicine, clinical social workers, a nd clinical psychologists, to order portable x-ray services. A few commenters stated that so me nonphysician and limited-license practitioners have not been trained to diagnose an illness, to us e x-rays as part of the diagnosis and treatment of a beneficiary, to know how to interpret an x-ray, and to plan a course of medically appropriate follow-up treatment. Commenters requested the c linical rationale and FY 2011 data on portable x-ray ordering by select nonphysician practitioners. One commenter stated that deferring to state scope of practice laws for limited- license a nd nonphysician practitioners did not constitute sufficient stewardship by Medicare to en sure payment for appropriate services. Response : We disagree. We proposed to modify our rule for ordering portable x-ray services to make it consistent with rules for ordering all other diagnostic tests. Our proposed policy would eliminate the specific requirement s limiting the types of practitioners who can order portable x-ray services, and instead place or dering for portable x-ray services under the general regulations governi ng ordering of diagnostic te sts in §410.32(a)(2). Under §410.32(a)(2), limitations on the ability of various practitioners to order diagnostic tests are established by the practitioner’s scope of practice under state law and the scope of the practitioner’s Medicare benefit. The current regulation applies to x-rays (other than portable xrays), MRI, CT scans, and a host of other diagno stic tests that are more complex and potentially higher risk than portable x-ray services. We do not believe that nonphysician and limitedlicense practitioners who can routinely order a nd employ the results of reasonable and necessary x-rays, MRIs, and CT scans should continue to be precluded from ordering and utilizing portable385 x-ray imaging in the same manner. Further, most of the nonphysician practitioners listed in §410.32(a)(2) are authorized by statute to furnish physician services under the scope of their Medicare benefit and state scope of practice, including orderi ng, interpreting, and using test results to treat a beneficiary. With regard to clinical social workers, under section 1861(hh) of the Act, the scope of their Medicare benefit is further limited to services “for the di agnosis and treatment of mental illnesses.” Therefore, the proposed change to our regulations to allow clinical social workers to order portable x-ray services in the same way th at they are permitted to order other diagnostic tests under §410.32(a) would not allo w clinical social workers to or der portable x-ray services. Portable x-ray services fall within the scope of the Medicare benefit for the remaining nonphysician and limited-license practi tioners, including clinical psyc hologists. As noted above, we believe state scope of practi ce laws might limit ordering of porta ble x-ray services by clinical psychologists or other practitioners . Additionally, certain other prac titioners are unlikely to have a reason to order portable x-ray services, such as doctors of optometry. We have no evidence to suggest that clinical psychol ogists or other limited license or nonphysician practitioners are ordering significant numbers of x-rays, CTs, a nd MRIs under §410.32(a) authority at this time. We do not expect any marked change in ordering patterns following the change in regulation to allow for ordering of portable x-ray services. With regard to the request for FY 2011 da ta on portable x-ra y ordering by select nonphysician practitioners, we do not believe this or any recent da ta on portable x-ray ordering patterns for limited-license or nonphysician prac titioners would be meaningful information regarding future potential or dering patterns for portable x- ray services because these practitioners are not permitted to order portable x-ray services under the current regulation. We believe our proposal is consiste nt with our current regulations that generally allow nonphysician practitioners to order diagnostic services, and the agency’s inte rest in having delivery systems386 take full advantage of all members of a heal thcare delivery team. We describe below our intention to design monitoring systems that will capture excessive ordering.
Comment : Several commenters requested that CMS clarify that the proposal for CY 2013 is actually a clarifi cation of long standing policy that nonphysician practitioners have been able to order portable x-ray services since im plementation of the thei r authority to order diagnostic tests under §410.32(a)(2) and requested that CMS indicate that th is authority is not a change in policy effective January 1, 2013. Co mmenters stated that the regulations at §410.32(a), established as a result of the Balan ced Budget Act (BBA) of 1997 (Pub. L. 105-33), were promulgated long after the 1969 CfC re quirement at §486.106 and that the more recent regulation trumps older requirements. These comm enters stated that it was merely an oversight on the part of CMS when the agency failed to update the regulations at §486.106. They also stated that some manual language and educati onal materials have been inconsistent in communicating that only MDs or DOs can order portable x-ray services over the years. Commenters requested that if CMS does c onclude that allowing nonphysician and limitedlicense practitioner ordering of portable x-ray serv ices is a change in policy for CY 2013, then CMS should specify in the preamble that no repaym ents or other actions are required, including recoupment efforts as a result of the OIG’s findings in the December 2011 report entitled Questionable Billing Patterns of Portable X-ray Suppliers (OEI 12-10-00190) Response : There is a longstanding regulation requiring ordering of portable x-ray services by an MD or DO at §486.106(a) and §486.106( b). There is a speci fic section of the regulation under §410.32 dedicated to portable x- ray services, §410.32(c), that explicitly crossreferences the requirements under §486.106. As suc h, we do not believe that, when revising the regulation at §410.32 to expand the general rule s for ordering diagnosti c tests under the BBA, the agency simply failed to notice the requirement in the same section relating to portable x-ray tests. Further, the specific requirement for MD or DO ordering of portable x-ray services under387 §410.32(c) explicitly excepts portabl e x-ray services from the general ordering rules under §410.32(a). The only means to revise the regu lations containing this longstanding CfC is through notice and comment rulemaking, which was th e purpose of the proposal we made in the CY 2013 proposed rule. The change in polic y to allow limited-license and nonphysician practitioners to order portab le x-ray services will be effective beginning in CY 2013. The OIG report concluded, and CMS concur red, that CMS should recoup payment for portable x-ray services identified under the re port as ordered by limited-license physicians and nonphysician practitioners, other than a MD or DO in accordance with our regulations at §410.32(c) and §486.106 since this was consistent w ith this recommendation. We will continue our recoupment efforts in response to the OIG repo rt. However, we have instructed our payment contractors that the ordering of portable x-ray services should not be made a priority for additional medical review activity beyond cl aims identified in the OIG audit. After considering the public comments re ceived, we are finalizing our CY 2013 proposal to revise the CfC at §486.106(a) and §486.106(b) to permit portable x- ray services to be ordered by physicians or nonphysician practitioners in acco rdance with the general ordering policies for other diagnostic services as specified under §410.32(a). Theref ore, effective for services furnished on or after January 1, 2013, the following practitioners will be permitted to order portable x-rays in accordance with Medicare regul ations and subject to their scope of practice under state law and their applicable Medicare stat utory benefit: a physician (including an MD or a DO, doctor of optometry, doctor of dental surger y and doctor of dental medicine, and doctor of podiatric medicine), or a nurse prac titioner, clinical nurse speciali st, physician assistant, certified nurse-midwife, or clinical psychologist, where th e ordering of portable x-ray services is within the scope of their practice under state law. As discussed above, although clinical social workers are permitted to order diagnostic tests under §410.32(a )(2), the scope of their Medicare benefit is limited to services for the diagnosis and treatm ent of mental illnesses. As such, we do not388 believe these nonphysician practitione rs would need to order portab le x-ray services. We also are finalizing revisions to the language included under §410.32(c) specific to portable x-ray services to recognize the same authority for phys icians and nonphysician pr actitioners to order diagnostic tests as is prescribed for ot her diagnostic services under §410.32(a). Finally, we are finalizing two technical corrections that we proposed to make in the CY 2013 PFS proposed rule. One is to §410.32(d)(2), wher e we currently cite pa ragraph (a)(3) for the definition of a qualified nonphysicia n practitioner. The definition of a qualified nonphysician practitioner is currently found in paragraph (a )(2),while paragraph (a)(3) does not exist; therefore, we are correcting th e citation. The second technical correction is in §410.32(b)(2)(iii) to better reflect the statutory authority to furnish neuropsycho logical testing in addition to psychological testing. We did not receive any comments on these proposed technical corrections. The documentation requiremen t for this paragraph remains unchanged. Although we believe it is appropriate to finalize policy to allow nonphysician practitioners and limited-license practitioners to or der portable x-ray services within the scope of their authority under state law and the scope of their Medicare statutor y benefit given overall changes in health care delivery practice patterns since the beginning of the Medicare program, we remain concerned about the OIG’s recent fi ndings. The OIG observed other questionable billing patterns for portable x- ray services in addition to or dering by nonphysician practitioners. Of specific note was the observation that some porta ble x-ray suppliers are furnishing services on the same day that the beneficiary also receives se rvices in a clinical setting, such as the physician office or hospital. Under current regulations at §486.106(a)(2), the or der for portable x-ray services must include a statement concerning th e condition of the beneficiary which indicates why portable x-ray services are n ecessary. If, on the same day th at a portable x-ray service was furnished, the patient was able to travel safely to a clinical setting, we believe the statement of need for portable x-ray services could be questionable. We al so are concerned that the OIG389 observed some portable x-ray suppliers billing fo r multiple trips to a facility on the same day Medicare makes a single payment for each trip th e portable x-ray supplier makes to a particular location. We make available several modifiers to allow the portable x- ray supplier to indicate the number of beneficiaries served on a single tr ip to a facility. We expect portable x-ray suppliers to use those modifiers and not to bill mu ltiple trips to the same facility on a single day when only one trip was made. Additionally, we strongly encourage portabl e x-ray suppliers to make efficient use of resources a nd consolidate trips, to the extent it is clinically appropriate to do so, rather than making multiple trips on the same day.
Comment : Several stakeholders provided scenar ios where a portable x-ray service would be medically necessary on the same day as a hosp ital, physician office, or other clinical setting. Response : We agree that there may be unusua l circumstances when portable x-ray services could be appropriate with a same day visit to a hospital, physician office, or other clinical setting. Proper documenta tion of the rationale for such same day occurrences would be required to substantiate the necessity for those services. In conjunction with our proposal to expa nd the scope of physicians and nonphysician practitioners who can order portabl e x-ray services, we intend to develop, as needed, monitoring standards predicated by these and other OIG fi ndings. In addition, we will be conducting data analysis of ordering patterns for portable x-ray and other diagnostic serv ices to determine if additional claims edits, provider a udits, or fraud investigations ar e required to prevent abuse of these services and to allow for the collection of any potential overpayments. We encourage physicians and practitioners, as with any diagnos tic test, to proactively determine and document the medical necessity for this testing.
Comment: One commenter noted that our proposa l to expand the scope of ordering for portable x-ray services was at odds with our statements indicating our intent to engage in greater monitoring of the delivery of portable x-ray serv ices overall. The commenter recommended that390 we target any new program integrity efforts to practitioner groups where there is evidence of abuse. Response: We disagree. We believe a llowing nonphysician and limited-license practitioners to order portable x -ray services is consistent with statutory authority and changes in health care delivery. Any monitoring effort wo uld target more genera lly, the utilization and delivery of portable x-ray services, of which of the actual x-ray service is only one small component. In the proposed rule (77 FR 44791), we so licited comments and suggestions for updating the current regulations at 42 CFR Part 486, Subpa rt C—Conditions for Coverage: Portable XRay Services through future rulemaking. Belo w are our responses to public comments on suggestions for future rulemaking at 42 CFR Part 486, Subpart C—Conditions for Coverage: Portable X-Ray Services.
Comment : One commenter suggested CMS clarify the differences between portable xray providers and mobile independent diagnostic testing facilities (ID TFs). The commenter specifically recommended that CMS clarify whet her portable x-ray suppli ers and mobile IDTFs can furnish the same services to Medicare benefi ciaries or whether there are limitations on the types of services that portab le x-ray suppliers and IDTFs can furnish. The commenter also recommended that CMS establish educational and training requirements for portable x-ray suppliers and IDTF technicians. Response : We appreciate these comments and will take them into consideration when undertaking future rulemaking.391 M. Addressing Interim Final Relative Value Units (RVUs) from CY 2012 and Establishing Interim Final RVUs for CY 2013 Section 1848(c)(2)(B) of the Ac t requires that we review RVUs for physicians’ services no less often than every 5 years. Under secti on 1848(c)(2)(K) of the Ac t (as added by section 3134 of the Affordable Care Act), we are requir ed to identify and revise RVUs for services identified as potentially misvalued. To facilit ate the review and appropriate adjustment of potentially misvalued services, section 1848(c)(2 )(K)(iii) specifies that the Secretary may use existing processes to receive recommendations; c onduct surveys, other data collection activities, studies, or other analyses as the Secretary de termined to be appropr iate; and use analytic contractors to identify and analyze potentiall y misvalued services, conduct surveys or collect data. In accordance with sect ion 1848(c)(2)(K)(iii ) of the Act, we identi fy potentially misvalued codes, and develop and propose appropriate adju stments to the RVUs, taking into account the recommendations provided by the AMA RUC, the Medicare Payment Advisory Commission (MedPAC), and other public commenters. For many years, the AMA RUC has provi ded CMS with recommendations on the appropriate relative values for PFS services. Ov er the past several years, CMS and the AMA RUC have identified and reviewed a number of potentially misvalued codes on an annual basis, based on various identification screens for codes at risk for being misvalued. This annual review of work RVUs and direct PE inputs for potential ly misvalued codes was further bolstered by the Affordable Care Act mandate to examine potentia lly misvalued codes, with an emphasis on the following categories specified in section 1848( c)(2)(K)(ii) (as added by section 3134 of the Affordable Care Act):

• Codes and families of codes for which there has been the fastest growth.392

• Codes or families of codes that have experienced substantial changes in practice
expenses.

• Codes that are recently establishe d for new technologies or services.

• Multiple codes that are frequently billed in conjunction with furnishing a single service.

• Codes with low relative values, particularly those that are often billed multiple times for a single treatment.

• Codes which have not been subject to re view since the implem entation of the RBRVS (the “Harvard-valued” codes).

• Other codes determined to be appropriate by the Secretary. In addition to providing recommendations to CMS for work RVUs, the AMA RUC's Practice Expense Subcommittee reviews, and then the AMA RUC recommends, direct PE inputs (clinical labor, medical supplies, and medical equipment) for indi vidual services. To guide the establishment of malpractice RVUs for new and revised codes before eac h Five-Year Review of Malpractice, the AMA RUC also provides malp ractice crosswalk recommendations, that is, “source” codes with a similar specialty mix of practitioners furnishing the source code and the new/revised code. CMS reviews the AMA RUC recommendations on a code-by-code basis. For AMA RUC recommendations regarding physician work RVUs, after conducting a clinical review of the codes, we determine whether we agree with the recommended work RVUs for a service (that is, whether we agree the AMA RUC-recommended va luation is accurate). If we disagree, we determine an alternative value that better reflec ts our estimate of the physician work for the service. Because of the timing of the CPT Editorial Panel decisions, the AMA RUC recommendations, and our rulemaking cycle, we pub lish these work RVUs in the PFS final rule393 with comment period as interim final values, su bject to public comment. Similarly, we assess the AMA RUC's recommendations for direct PE inputs and malpractice crosswalks, and establish PE and malpractice interim final values , which are also subject to comment. We note that, with respect to interim final PE RVUs, the aspect of our valuation that is open for public comment for a new, revised, or potentially misval ued code is the direct PE inputs and not the other elements of the PE valuation methodol ogy, such as the indir ect cost allocation methodology, that also contribute to es tablishing the PE RVUs for a code. If we receive public comments on the interi m final work RVUs for a specific code indicating that refinement of th e interim final work value is warranted based on sufficient and new information from the commenters concerni ng clinical aspects of the physician work associated with the service (57 FR 55917) that we re not already considered in making the interim valuation or the AMA RUC deliberations, we re fer the service to a refinement panel, as discussed in further detail in section III.M.1.a. of this fi nal rule with comment period. In the interval between cl osure of the comment period a nd the subsequent year's PFS final rule with comment period, we consider all of the public comments on the interim final work, PE, and malpractice RVUs for the new, re vised, and potentially misvalued codes and the results of the refinement panel, if applicable. Finally, we address the interim final RVUs (including the interim final direct PE inputs) by providing a summary of the public comments and our responses to those comments, including a discussion of any changes to the interim final work or malpractice RVUs or direct PE inputs, in the follo wing year's PFS final rule with comment period. We typically finalize the direct PE inputs and the work, PE, and malpractice RVUs for the service in that year's PFS final rule with comment period, unless we determine it would be more appropriate to c ontinue their interim final stat us for another year and solicit further public comment.394
1. Methodology We conducted a clinical review of each code identified in this sect ion and reviewed the current and recommended work RVUs, intensity, and time to furnish the pre-service, intraservice, and post-service activities, as well as other component s of the service th at contribute to the value. Our clinical review generally includes, but is not lim ited to, a review of information provided by the AMA RUC and other public commen ters, medical literature, and comparative databases, as well as a comparison with other codes within the Medicar e PFS, consultation with other physicians and healthcare professionals within CMS and the Federal Government, and the views based on clinical experien ce of the physicians on the PFS clin ical review team. We also assessed the methodology and data used to deve lop the recommendations submitted to us by the AMA RUC and other public commenters and the rationale for the recommendations. As we noted in the CY 2011 PFS final rule with comment period (75 FR 73328 through 73329), there are a variety of methodologies a nd approaches used to develop work RVUs, including building block, survey data, crosswalk to key reference or similar codes, and magnitude estimation. The building block methodology is used to construct, or deconstruct, the work RVU for a CPT code based on component pieces of th e code. Components may include pre-, intra-, or post-service time and post-procedure visits, or, when referr ing to a bundled CPT code, the components could be considered to be the CPT codes that make up the bundled code. Magnitude estimation refers to a methodology for valuing physician work that determines the appropriate work RVU for a service by gauging the total amount of physician wo rk for that service relative to the physician work for similar service across the physician fee schedule without ex plicitly valuing the components of that work. The resource-based re lative value system (RBRVS) has incorporated into it cross-specialty and cross-organ system relativity. This RBRVS requires assessment of relative value and takes into account the clinical in tensity and time required to perform a service.395 In selecting which methodologica l approach will best determin e the appropriate value for a service, we consider the current and recomme nded physician work and time values, as well as the intensity of the service, all relative to other services. Several years ago, to aid in the developmen t of pre-service time recommendations for new and revised CPT codes, the AMA RUC created standardized pre-service time packages. The packages include pre-service evaluation tim e, pre-service positioning time, and pre-service scrub, dress and wait time. Curre ntly there are six pre-servic e time packages for services typically furnished in the facility setting, reflect ing the different combinat ions of straightforward or difficult procedure, straightforward or difficult patient, an d without or with sedation/anesthesia. Currently there are two pre- service time packages for services typically furnished in the nonfacility setti ng, reflecting procedures without and with sedation/anesthesia

care. We have developed several standard building block methodologies to appropriately value services when they have very common billing patterns. As we have discussed in past rulemaking, most recently in the CY 2012 PFS fi nal rule with comment period (76 FR 73107 through 73108), in cases where a service is typica lly furnished to a beneficiary on the same day as an evaluation and management (E/M) service, we believe that there is overlap between the two services in some of the activities furnished du ring the pre-service evaluation and postservice time. We believe that at least one-thi rd of the physician time in both the pre-service evaluation and post-servi ce period is duplicative of work fu rnished during the E/M visit. Accordingly, in cases where we believe that th e AMA RUC has not adequately accounted for the overlapping activities in the re commended work RVU and/or times, we adjust the work RVU and/or times to account for the overlap. The wo rk RVU for a service is the product of the time involved in furnishing the service times the intensity of the wor k. Pre-service evaluation time396 and post-service time both have a long-established intensity of wo rk per unit of time (IWPUT) of .0224, which means that 1 minute of pre-service evaluation or pos t-service time equates to .0224 of a work RVU. Therefore, in many cases wher e we remove 2 minutes of pre-service time and 2 minutes of post-service time from a procedure to account for the overlap with the same day E/M service, we also remove a work RVU of .09 (4 minutes x .0224 IWPUT) if we do not believe the overlap in time has already been accounted for in the work RVU. We continue to believe this adjustment is appropriate. The AMA RUC has recognized this valuation policy and, in many cases, addresses the overlap in time and work wh en a service is typical ly provided on the same day as an E/M service. We appreciate the creation and use of these standardized pre-service time packages. However, we believe that servi ces that involve only a local anesthetic agent do not typically involve the same amount of pre-service time as procedures involving sedation or non-local anesthesia care. We request th at the AMA RUC consider assigni ng services that require only local anesthesia without sedation to the “no sedation/anesthesia ca re” pre-service time package, or that the AMA RUC create one or more new pr e-service time packages to reflect the preservice time typically involved in furn ishing local anesthesia without sedation. For many CPT codes that are t ypically billed on the same da y as an E/M service, the recommendations from the AMA RUC state that the AMA RUC reviewed the work associated with the procedure, and adjusted the pre-service and/or post-service time to account for the work that is furnished as a part of the E/M service. For many codes, the AMA RUC made this adjustment from the pre-service evaluation time included in the AMA RUC-selected pre-service time package. However, as we noted above, we believe that the pre-service time packages for procedures with sedation or an esthesia care may overstate the time involved in furnishing services that involve only local or topical anesthesia without sedation. As a result, though the397 AMA RUC may have removed some pre-service tim e from the package to account for the same day E/M service, in a few instances, consistent with our established same day E/M reduction methodology discussed above, we further reduc ed the AMA RUC-recommended pre-service evaluation time to fully account for the overla pping time with the same day E/M service.

2. Finalizing CY 2012 Interim and CY 2013 Proposed Values for CY 2013 In this section, we address the interim final values published in the CY 2012 PFS final rule with comment period (76 FR 73026 thr ough 73474), as subsequently corrected in the January 4, 2012 (77 FR 227 through 232) correction not ice; and the proposed values published in the CY 2013 PFS proposed rule (77 FR 44722 through 45061). We discuss the results of the CY 2012 refinement panels for certain CY 2012 in terim final code values, respond to public comments received on specific interim final and pr oposed values (including direct PE inputs), and address the other new, revise d, or potentially misvalued codes with interim final or proposed values. The final CY 2013 direct PE database that lists the direct PE i nputs is available on the CMS website under the downloads for the CY 2013 PFS final rule with comment period at: www.cms.gov/PhysicianFeeSched/. The final CY 2013 work, PE, and malpractice RVUs are displayed in Addendum B to this fi nal rule with comment period at: www.cms.gov/PhysicianFeeSched/

.

a. Finalizing CY 2012 Interim and Proposed Work RVUs for CY 2013
i. Refinement Panel (1) Refinement Panel Process As discussed in the 1993 PFS final rule w ith comment period (57 FR 55938), we adopted a refinement panel process to assist us in reviewing the public comments on CPT codes with398 interim final work RVUs for a year and in develo ping final work values for the subsequent year. We decided the panel would be comprised of a multispecialty group of physicians who would review and discuss the work involved in each procedure under review, and then each panel member would individually rate the work of the procedure. We believed establishing the panel with a multispecialty group would balance the interests of the specialty societies who commented on the work RVUs with the budgetary a nd redistributive effects that could occur if we accepted extensive increases in work RVUs across a broad range of services. Depending on the number and range of codes th at are subject to refinement in a given year, we establish refinement panels with re presentatives from four groups of physicians: clinicians representing the specialty most identifi ed with the procedures in question; physicians with practices in rela ted specialties; primary care physicians ; and contractor medical directors (CMDs). Typical panels have included 8 to 10 physicians across the four groups. Following the addition of section 1848(c )(2)(K) to the Act by Section 3134 of the Affordable Care Act, which authorized the Secr etary to review potentially misvalued codes and make appropriate adjustments to the RVUs, we r eassessed the refinement panel process. As detailed in the CY 2011 PFS final rule with comm ent period (75 FR 73306), we believed that the refinement panel process may provide an opportu nity to review and di scuss the proposed and interim final work RVUs with a clinically dive rse group of experts, who then provide informed recommendations. Therefore, we indicated that we would continue the refinement process, but with administrative modification an d clarification. We also noted that we would continue using the established composition that includes represen tatives from the four groups of physicians -- clinicians representing the specialty most identifi ed with the procedures in question, physicians with practices in rela ted specialties, primary care physicians, and CMDs. One change relates to the calculation of the refinement panel results. The basis of the399 process is that following discussion of the in formation but without an attempt to reach a consensus, each member of the panel votes inde pendently. Historically, the refinement panel’s recommendation to change a work value or to re tain the interim value had hinged solely on the outcome of a statistical test on the ratings (an F-test of pa nel ratings among the groups of participants). Over time, we found the statistical test used to evaluate the RVU ratings of individual panel members became less reliable as the physicians in each group tended to select a previously discussed value, rather than develo ping a unique value, ther eby reducing the observed variability needed to co nduct a robust statis tical test. In addition, re liance on values developed using the F-test also occasiona lly resulted in rank order anoma lies among services (that is, a more complex procedure is assigned lower RVUs than a less complex procedure). As a result, we eliminated the use of the statistical F-test an d instead indicated that we would use the median work value of the individual pane l members’ ratings. We said th at this approach would simplify the refinement process administratively, while providing a result that reflects the summary opinion of the panel members based on a commonly us ed measure of central tendency that is not significantly affected by outlier va lues. At the same time, we clarified that we have the final authority to set the RVUs, incl uding making adjustments to the work RVUs resulting from the refinement process, and that we will make su ch adjustments if warranted by policy concerns (75 FR 73307). As we continue to strive to make the refine ment panel process as effective an efficient as possible, we would like to remi nd readers that the refinement pa nels are not intended to review every code for which we did not propose to ac cept the AMA RUC-recommended RVUs. Rather the refinement panels are designed for situations where there is new info rmation available that might provide a reason for a change in work values and for which a multi-specialty panel of physicians might provide input that would assist us in making work RVU decisions. To facilitate400 the selection of services for the refinement pa nels, we would like to remind specialty societies seeking reconsideration of propos ed or interim final work RVUs, including consideration by a refinement panel, to specifically state they are requesting refinement pane l review in their public comment letters. Furthermore we have asked commenters reque sting refinement panel review to submit sufficient new information concerning the clinical aspects of the work assigned for a service to indicate that referral to the refinement panel is warranted (57 FR 55917). We note that the majority of the information presented during the CY 2012 refinement panel discussions was duplicative of the information provided to the AMA RUC during its development of recommendations. As detailed in section III.B. of this final rule with comment period, we consider information and recommendations fr om the AMA RUC when assigning proposed and interim final RVUs to services. Thus, if the onl y information that a commenter has to present is information already considered by the AMA RU C, referral to a refinement panel is not appropriate. To facilitate selection of codes for refinement, we request that commenters seeking refinement panel review of work RVUs submit supporting information that has not already been considered the AMA RUC in creating recomm ended work RVUs or by CMS in assigning proposed and interim final work R VUs. We can make best use of our resources as well as those of the specialties involved a nd physician volunteers, by avoidi ng duplicative consideration of information by the AMA RUC, CMS, and a refinement panel. To achieve this goal, CMS will continue to critically evaluate the need to refe r codes to refinement panels in future years, specifically considering any new inform ation provided by commenters. (2) Interim Final Work RVUs Referred to the Refinement Panel in CY 2012 We referred to the CY 2012 refinement pane l 17 CPT codes with interim final work values for which we received a request for refine ment that met the process described above. For401 these 17 CPT codes, all commenters requested incr eased work RVUs. For ease of discussion, we will be referring to these services as “refinemen t codes.’’ Consistent with the process described above, we convened a multi-specialty panel of phys icians to assist us in the review of the comments. The panel was moderated by our physic ian advisors, and consisted of the following voting members:

• One to two clinicians representing the commenting organization;

• One to two primary care clinicians nominated by the American Academy of Family Physicians and the American College of Physicians;

• Four contractor medical directors (CMDs); and

• One to two clinicians with practices in related specialties who were expected to have knowledge of the services under review. The panel process was designed to capture each participant's independent judgment and his or her clinical experience which informed a nd drove the discussion of the refinement code during the refinement panel proceedings. Fo llowing the discussion, each voting participant rated the physician work of the refinement code and submitted those ratings to CMS individually and confidentially, w ith no attempt to achieve consen sus among the panel members. As finalized in the CY 2011 PFS final rule w ith comment period (75 FR 73307), we reviewed the ratings from each panel member and determined the median value for each service that was reviewed by the refinement panel. We note that the individual codes reviewed by the CY 2012 refinement panel, and their final work RVUs are discussed in section III.B.1 .b. of this final rule with comment period. Also, see Table 29 for the refinement panel ratings a nd the final work RVUs for the codes reviewed by the CY 2012 refinement panel.
TABLE 29: Codes Reviewed under the CY 2012 Refinement Panel Process402

CPT Code Short Descriptor CY 2012 Interim

Final WRVU AMA RUC/ HCPAC Recommend

ed Work

RVU 2012 Refinement

Median

Panel Rating CY 2013 Final WRVU 26341 Manipulat palm cord post inj 0.91 1.66 1.30 0.91 29581 Apply multlay comprs lwr leg 0.25 0.60 0.50 3 0.25 32096 Open wedge/bx lung infiltr 13.75 17.00 17.00 13.75 32097 Open wedge/bx lung nodule 13.75 17.00 17.00 13.75 32098 Open biopsy of lung pleura 12.91 14.99 14.99 12.91 32100 Exploration of chest 13.75 17.00 17.00 13.75 32505 Wedge resect of lung initial 15.75 18.79 18.79 15.75 38230 Bone marrow harvest allogen 3.09 4.00 4.00 3.50 38232 Bone marrow harvest autolog 3.09 3.50 3.50 3.50 62370 Anl sp inf pmp /mdreprg&fil 0.90 1.10 1.10 0.90 92587 Evoked auditory test limited 0.35 0.45 0.45 0.35 92588 Evoked auditory tst complete 0.55 0.60 0.60 0.55 94060 Evaluation of wh eezing 0.26 0. 31 0.27 0.27 94726 Pulm funct tst plethysmograp 0.26 0.31 0.26 0.26 94727 Pulm function test by gas 0.26 0.31 0.26 0.26 94728 Pulm funct test oscillometry 0.26 0.31 0.26 0.26 94729 C02/membane diffuse capacity 0.17 0.19 0.19 0.19

ii. Code-specific Issues In this section, we discuss all code families for which we received a comment on an interim final physician work value in CY 2012 PFS final rule with comment period or on a proposed value in the CY 2013 PFS proposed rule . Refer to Addendum B for a comprehensive list of all final values. (1) Integumentary System: Skin, Subcutaneous , and Accessory Structures (CPT Code 11056) For discussion on CY 2013 interim final work values for CPT code 11056 refer to section III.M.3. of this final rule with comment period. (2) Integumentary System: Nails (CPT code 11719) For discussion on CY 2013 interim final work values for CPT code 11719 refer to section III.M.3. of this final rule with comment period.

3 This value is interim final for CY 2013.403 (3) Integumentary System: Repair (Closure) (CPT Codes 12035-12057) For discussion on CY 2013 interim final work values for CPT codes 12035 through12057 refer to section III.M.3. of this final rule with comment period. (4) Integumentary System: Repair (Closure) (CPT Codes 15272 and 15276) As detailed in the CY 2012 final rule w ith comment period (76 FR 73112), for CY 2012, the CPT Editorial Panel deleted 24 skin substitute codes and estab lished a 2-tier structure with 8 new codes (CPT codes 15271 through 15278) to report the application of skin substitute grafts, which are distinguished according to the anatom ic location and surface area rather than by product description. We assigned a work RVU of 0.33 to CPT c ode 15272 (Application of skin substitute graft to trunk, arms, legs, total wound surface ar ea up to 100 sq cm; each additional 25 sq cm wound surface area, or part thereof (List separately in addition to code for primary procedure)) on an interim final basis for CY 2012. After clinical review of CPT code 15272, we believed that a work RVU of 0.33 accurately reflected the work associated with this service. The AMA RUC reviewed the survey results for CP T code 15272 and recommended the survey 25th percentile work RVU of 0.59 for th is service. However, we be lieved this value overstated the work of this procedure when compared to the base CPT code 15271 (Application of skin substitute graft to trunk, arms, legs, total wound surface area up to 100 sq cm; first 25 sq cm or less wound surface area). We believed that CPT c ode 15272 is similar in intensity to CPT code 15341 (Tissue cultured allogeneic skin substitute; each additional 25 sq cm, or part thereof (List separately in addition to code fo r primary procedure)), and that the primary factor distinguishing the work of these two services is the intra-service physician time. CPT code 15341 has a work RVU of 0.50, 15 minutes of intra-service time , and an IWPUT of 0.0333. CPT code 15272 has 10 minutes of intra-service time. Ten minutes of intra-service work at the same intensity as CPT404 code 15341 is equal to a work RVU of 0.33 ( 10 minutes x 0.0333 IWPUT). Therefore, we assigned a work RVU of 0.33 to CPT code 15272 on an interim final basis for CY 2012.
Comment: Commenters opposed the CMS-recomme nded interim final work RVU of 0.33 assigned to CPT code 15272. Commen ters disagreed with our rati onale to crosswalk CPT code 15272 to CPT code 15341 and stated that CPT code 15003 (Surgical preparation or creation of recipient site by excision of ope n wounds, burn eschar, or scar (inc luding subcutaneous tissues), or incisional release of scar contracture, trunk, arms, legs; each additional 100 sq. cm, or part thereof, or each additional 1% of body area of infa nts and children (List se parately in addition to code for primary procedure), which has a work RVU of 0.80, is a more suitable comparison code. Commenters noted that although CPT code 15003 requires 15 minutes of intra-service time whereas CPT code 15272 requires 10 minutes, it is a more appropriate comparison for valuation of the services under this code. Commenters stated that the AMA RUC-recommended work RVU places this service in the proper ra nk order with the base code, CPT code 15271. Furthermore, commenters noted that if all th e AMA RUC recommendations for the family of CPT codes 15271 through15278 were accepted, the re sult would be financial savings for Medicare. Therefore, commenters recomme nded that we accept the AMA RUC-recommended work RVU of 0.59 for CPT code 15272. Response: Based on the comments received, we re-reviewed CPT code 15272 and continue to believe that CPT code 15272 is similar in intensity to CPT code 15341. The primary distinguishing factor between the two services is that CPT code 15272 has 10 minutes of intraservice time and CPT code 15341 has 15 minutes. We continue to believe that the AMA RUCrecommended work RVU overstates the intensity of this procedure compared to the base procedure CPT code 15271. We main tain that valuing the 10 minutes of intra-service work at the same intensity as CPT code 15341, which equa tes to a work RVU of 0.33, is appropriate.405 We believe that this resulting work RVU maintain s appropriate relativity with the base code and the entire family of CPT code s (15271 through15278). Therefore, we are finalizing a work RVU of 0.33 for CPT code 15272. We assigned a work RVU of 0.50 to CPT c ode 15276 (Application of skin substitute graft to face, scalp, eyelids, mouth, neck, ears, orbits, genitalia, hands, feet, and/or multiple digits, total wound surface area up to 100 sq cm; each additional 25 sq cm wound surface area, or part thereof (List separately in addition to code for primary procedure)) on an interim final basis for CY 2012 based on our clinical review of the work associated with th is service. The AMA RUC reviewed the survey results for CPT code 15276 and recommended a work RVU of 0.59, which corresponds to the AMA RUC's recomm ended work RVU for CPT code 15272. We disagreed with the AMA RUC that these two CPT codes should be valued the same. We assigned an interim final work RVU of 0.33 to CPT code 15272 but believed that the work associated with CPT code 15276, which describes work on the face, scalp, eyelids, mouth, neck, ears, orbits, genitalia, hands, feet, and/or multiple digits, is more intense than the work associated with CPT code 15272, which describes work on the trunk, arms, and legs. Accordingly, we noted that our interim final work RVU for CPT code 15276 accurately captured the work associated with this service and established th e appropriate relativity between the services. Therefore, we assigned a work RVU of 0.50 to CPT code 15276 on an interim final basis for CY
2012.
Comment: Commenters disagreed with the CMS-recommended interim final work RVU for CPT code 15276. Commenters suggested that CPT code 15276 is analogous to CPT code 15272, for which the AMA RUC originally recommended a work RVU of 0.59, both in physician work and time and recommended that CPT code 15276 should be directly crosswalked to CPT code 15272. Further, the commenters agr eed with the AMA RUC key reference to CPT406 code 15003 (Surgical preparation or creation of recipi ent site by excision of open wounds, burn eschar, or scar (including subcutaneous tissues), or incisional release of scar contracture, trunk, arms, legs; each additional 100 sq. cm, or part thereof, or each additi onal 1% of body area of infants and children), which has a work RVU of 0.80, and stated that CPT code 15276 requires 5 minutes less intra-service time, 10 minutes versus 15 minutes, and requires less physician work to perform. Commenters recommended th at we value CPT code 15276 based upon the AMA RUC-recommended work RVU of 0.59 for CPT code 15276. Response: Based on the comments received, we re-evaluated whether CPT code 15003 was an appropriate comparison code for CPT code 15276. However, we concluded that the services of CPT code 15276 are more intense than those of CPT code 15272 accordingly; CPT code 15276 should be valued to reflect the differe nce in intensity. We believe a work RVU of 0.50 establishes the appropriate difference in inte nsity between these two services. Additionally, we believe this work RVU value maintains approp riate relativity with the base code, CPT code 15271, and maintains relatively within the enti re family of CPT codes (15271 through15278). Therefore, we are finalizing a wo rk RVU of 0.50 for CPT code 15276. (5) Musculoskeletal: Hand and fingers (CPT Code 26341) CPT code 26341 (Manipulation, palmar fascial cord (ie, Dupuytren's cord), post enzyme injection (eg, collagenase), single cord) was created by the CPT Editorial Panel along with CPT code 20517 to describe a technique for treating Dupuytren's contract ure by injecting an enzyme into the Dupuytren's cord for full finger extension and mani pulation, effective January 1, 2012. As detailed in the CY 2012 final rule with co mment period, we assigned an interim final work RVU of 0.91 to CPT code 26341 (76 FR 73192). After reviewing survey results for CPT code 26341, the AMA RUC recommended a work RVU of 1.66, which co rresponds to the survey 25th percentile value. After clinical review of CPT code 26341, we be lieved the service described by CPT code 26341 is analogous to that of CPT code 97140 (Manual ther apy techniques (eg, mobilization/ manipulation,407
manual lymphatic drainage, manual traction), 1 or more regions, each 15 minutes), which has a work RVU of 0.43. However, since CPT code 97140 has no post-service visits (global period=XXX), while CPT code 26341 includes 1 CPT code 99212 (level 2 o ffice or outpatient visit) (global period= 010), we added the work RVU of 0.48 for CPT code 99212, to the work RVU of 0.43 for CPT code 97140 to obtain the work RVU of 0.91 for CPT code 26341.
Comment: Commenters disagreed with our decision to crosswalk the work RVU of CPT code 26341 to that of CPT code 97140, stating that the codes do not have comparable work because CPT code 97140 is performed by physical therapists while su rgeons perform CPT code 26341. Commenters also stated that the work associated with CPT code 26341 includes local or regional anesthesia and the procedure may result in skin rupture, requiring phys ician attention to manipulation. In addition, commenters noted that the post-procedure neurov ascular assessment involved in CPT code 26341 is added physician work that is distinctly different from the manual therapy techniques furnished in CPT code 97140. Commenters asserted that the difference in physician work, intensity, and complexity distinguishes the two codes. Commenters also disag reed with our use of a reverse building block methodology to value the additional work and complexity and said that we arbitrarily reduced the value of the surgeon's work involved. Commenters recommende d we instead value the code based upon the AMA RUC-recommended work RVU of 1.66 for CPT code 26341 and requested refinement panel review of the code. Response: Based on comments received, we refe rred CPT code 26341 to the CY 2012 multispecialty refinement panel for further review. Th e refinement panel median work RVU for CPT code 26341 was 1.30. We believe that the refinement panel median work RVU would create a rank order anomaly between this code and similar codes. A lthough CPT code 97140 is typically furnished by a physical therapist, we do not believe that the differe nce in the provider specia lty typically furnishing the service results in a difference in intensity of the service. Commenters stated that the post-procedure assessment involved in CPT code 26341 added physician work that is distinctly different from the manual therapy techniques furnished in CPT code 97140. We disagree; both services require an assessment following manipulation appropriate to the provided service to determine the adequacy and outcome, both408
positive and negative, of the interven tion and attention to an atypical r esponse to treatment. We continue to believe that the crosswalk and reverse building block methodologies that we used in assigning the interim final work value are appropriate and th e resulting work RVU accurately reflects the work associated with this service. After consideration of the public comments, refinement panel median, and our clinical review, we are finalizing a work RVU of 0.91 for CPT code 26341. (6) Musculoskeletal: Application of Casts and Strapping (CPT Codes 29581-29584) For discussion on interim final work values for CPT codes 29581, 29582, 29583, and 29584 refer to section III.M.3. of this final rule with comment period. (7) Respiratory: Lungs and Pleura (CPT Codes 32096-32100, 32505) In the CY 2012 final rule with comment period, we assigned an interim final work RVU of 13.75 for CPT code 32096 (Thoracotomy, with dia gnostic biopsy(ies) of lung infiltrate(s) (eg, wedge, incisional), unilateral) ( 76 FR 73193). As we noted, the CPT Editorial Panel reviewed the lung resection family of codes and deleted ei ght, revised five, and created 18 new codes to describe thoracoscopic procedures effec tive January 1, 2013. For the wedge resection procedures, the revisions were based on three tiers; first, the approach, thoracotomy or thoracoscopy; second, the target to remove nodules or infiltrates; a nd lastly the intent, diagnostic or therapeutic (for nodules only, all infiltrates will be removed for diagnostic purposes). As we noted in the CY 2012 final rule with comment period, after clinical review of CPT code 32096, we believed a work RVU of 13.75 accurately reflected the work associated with this service compared to other related services. The AMA RUC reviewed the survey results, compared the code to other services, and conclu ded that the survey 25th percentile work RVU of 17.00 appropriately accounted for the work a nd physician time required to perform this procedure. We determined that the work asso ciated with CPT code 32096 was similar in terms of physician time and intensity to CPT code 44300 (Placement, enterostomy or cecostomy, tube open (eg, for feeding or decompression) (separate pr ocedure)). Therefore, we assigned the same409

work RVU to CPT code 32096 as that of CPT co de 44300 on an interim final basis for CY 2012.
Comment: Commenters stated that CPT code 44300 is an arbitrary crosswalk, noting that CPT code 32096 describes an open thoracic procedure whereas CPT code 44300 is the placement of a feeding tube. A commenter shar ed a regression analysis of physician time and physician work of all thoracic surgery codes, wh ich showed that the interim final work RVU value falls below the regression line and stated that this indicated an inappropriate work value. Commenters stated our work valu es are lower for equivalent physic ian time than virtually all our prior decisions for the specialty. Additionally, commenters noted that the values result in IWPUT values that are approximately half of t hose ordinarily associated with major surgical procedures. Therefore, comment ers stated that the interim final work RVU of 13.75 for CPT code 32096 would result in rank order anomalies with other codes in the p hysician fee schedule. Commenters recommended we use the AMA RUC-recommended work RVU of 17.00 and requested refinement panel review of the code. Response: Based on comments received, we refe rred CPT code 32096 to the CY 2012 multispecialty refinement panel for further review. Th e refinement panel median work RVU for CPT code 32096 was 17.00. Following the refinement panel, we again conducted a clinical review and continue to believe a work RVU of 13.75 accurately reflected the work associated with this service. For CY 2012, the CPT Editorial Panel deleted C PT code 32095 which had a work RVU of 10.14 and created CPT codes 32096, 32097, and 32100 to replace CPT code 32095. Upon our clinical review, we do not believe that there is a significant difference in intensity between deleted CPT code 32095 an d replacement CPT code 32096. We believe that the appropriate work RVU for CPT code 32096 should be close to a work RVU of 10.14, but should account for the increase in 15 mi nutes of total time betwee n deleted CPT code 32095 and new CPT code 32096. We believe that the re finement panel median work RVU of 17.00 far overstates this difference. Additionally, we continue to believe that the work associated with 32096 is similar in terms of physician time a nd intensity to CPT code 44300. Ther efore, we still believe the work410
RVU of 13.75 appropriately values this service. Afte r consideration of the public comments, refinement panel results, and our clinical review, we are assi gning a work RVU of 13.75 as the final value for CPT code 32096. As detailed in the CY 2012 final rule with comment period, we assi gned an interim final work RVU of 13.75 for CPT code 32097 (Thoracot omy, with diagnostic biopsy(ies) of lung nodule(s) or mass(es) (eg, wedge, incisional), unilateral) (76 FR 73194). We noted that after clinical review of CPT code 32097, we believe d a work RVU of 13.75 accurately reflected the work associated with this service compared to other related services. We also noted that the AMA RUC had reviewed the specialty society su rvey results, compared the code to other services, and recommended the survey 25th percen tile work RVU of 17.00. We stated that we determined that the work associated with CPT code 32097 was similar to CPT code 32096, to which we assigned a work RVU of 13.75 on an in terim final basis for CY 2012. Therefore, we assigned a work RVU of 13.75 for CPT code 32097 on an interim final basis for CY 2012.
Comment: Commenters stated that CPT code 44300 is an arbitrary crosswalk for CPT code 32097 because it describes an open thorac ic procedure whereas CPT code 44300 is the placement of a feeding tube. Commenters shared a regression analysis of physician work and time for all thoracic surgery codes, which shows that the interim final work RVU value falls below the regression line and noted that this in dicates inappropriately low work intensity. Commenters stated our interim fi nal work RVU values are lower for equivalent physician time than virtually all prior work RVU decisions for this specialty. Commenters noted that the interim final work RVU values result in IWPUT values that are approximately half of those ordinarily associated with major surgical proced ures. Commenters added that the interim final work RVU of 13.75 for CPT code 32097 result in rank order anomalies with other codes. Commenters recommended we instead use the AMA RUC-recommended work RVU of 17.00 for CPT code 32097 and requested refinement panel review of the code.411
Response: Based on comments received, we refe rred CPT code 32097 to the CY 2012 multispecialty refinement panel for further review. Th e refinement panel median work RVU for CPT code 32097 was 17.00. CPT codes 32096, 32097, and 32100 were created to replace CPT code 32095, which was deleted, effective January 1, 2012. We belie ve these three services involve the same amount of physician work and should have the same work RVU. Thus, the same rationale that we used to value CPT code 32096 applies to CPT code 32097. We continue to believe th at the work associated with CPT code 32097 is similar in terms of physician time and intensity to CPT code 44300 and thus, still believe the work RVU of 13.75 is appropriate. Additionally, we continue to believe that a work RVU of 17.00 overstates the increase in work between deleted CPT code 32095 and its replacement CPT codes. After consideration of the public comments, refinement pa nel results, and our clinical review, we are assigning a work RVU of 13.75 as the final value for CPT code 32097. As detailed in the CY 2012 final rule with co mment period, we assigned an interim final work RVU of 12.91 to CPT code 32098 (Thoracotomy, with biopsy(ies) of pleura) (76 FR 73194). We noted that after clinical review , we believed a work RVU of 12.91 accurate ly reflected the work associated with this service as compared to other related services. Af ter reviewing survey results and comparing the code to other services, the AMA RUC recommended the survey 25th percentile work RVU of 14.99. We noted that the work associated with CPT code 32098 was si milar in terms of physician time and intensity to CPT code 47100 (Biopsy of liver, wedge) and therefor e we believed that crosswalking to the work RVU of CPT code 47100 appropriately accounted for the wo rk associated with CPT code 32098. Therefore, we assigned a work RVU of 12.91 to CPT code 32098 on an interim final basis for CY 2012. Comment: Commenters shared a regression anal ysis of physician time and physician work of all thoracic surgery code s, and indicated that our inte rim final work RVU value falls below the regression line, which commenters noted indicated inappropriately low work intensity. Commenters stated that a work RVU of 12.91 results in an IWPUT of 0.0741, which is insufficient intensity compared to other similar pr ocedures. Commenters stated that our interim final work RVU of 12.91 for CPT code 32098 placed th is service out of relativity with the CPT412 codes in this family for which we accepte d the AMA RUC recommendations and requested refinement panel review of the code. Response: Based on comments received, we referred CPT code 32098 to the CY 2012 multispecialty refinement panel for further review. The refinement panel median was a work RVU of 14.99. This service would be out of rank order with the ot her services in the family described by CPT codes 32096, 32097, 32100, and 32505 if we adopted a work RVU of 14.99. As noted above, we continue to believe a work RVU of 13.75 is appropriate for CPT code 32096. Since CPT code 32098 describes a more limited procedure that takes less time than th e other codes in the family (CPT codes 32096, 32097, 32100, and 32505) it should have a lower work RVU. After consideration of the public comments, refinement panel results, and our clinical review, we believe that that the work associated with 32098 is similar in terms of physician time a nd intensity to CPT code 47100 and therefore we are assigning a work RVU of 12.91 as the final value for CY 2013 for CPT code 32098. We assigned a work RVU of 13.75 for CPT c ode 32100 (Thoracotomy; with exploration) on an interim final basis in the CY 2012 final rule with comment period (76 FR 73194). After clinical review of CPT code 32100, we believe d a work RVU of 13.75 accurately reflected the work associated with this se rvice as compared to other re lated services. The AMA RUC reviewed the specialty society survey results, compared the code to other services, and recommended a work RVU of 17.00. We noted th at the affected specialty society and AMA RUC asserted that CPT code 32100 should be valued the same as CPT codes 32096 and 32097 because they believe that the work is similar for these three services. We noted that we assigned a work RVU of 13.75 to CPT codes 32096 and 32097, and therefore a work RVU of 13.75 to CPT code 32100 as well.
Comment: Commenters stated that CPT code 44300 is an inappropriate crosswalk for CPT code 32100 because it describes an open thor acic procedure whereas CPT code 44300 is the placement of a feeding tube. Commenters shared a regression analysis of physician work and413 time all thoracic surgery codes that shows the interim final work RVU value falls below the regression line and stated that this indicates in appropriately low work intensity. Commenters stated the interim final work RVU value is lowe r for equivalent physician time than virtually all prior work RVU assignments for this specialty. Commenters noted that the interim final work RVU value results in IWPUT values that are appr oximately half of those ordinarily associated with major surgical procedures. Therefore, comm enters stated that the interim final work RVU of 13.75 for CPT code 32100 would result in rank order anomalies with other codes in the feeschedule. Commenters recommended we value the work based upon the AMA RUCrecommended work RVU of 17.00 for CPT code 32100 and requested refinement panel review of the code. Response: Based on comments received, we refe rred CPT code 32100 to the CY 2012 multispecialty refinement panel for further review. Th e refinement panel median work RVU for CPT code 32100 was 17.00. CPT codes 32096, 32097, and 32100 were created to replace CPT code 32095, which was deleted, effective January 1, 2012. We belie ve these three services involve the same amount of physician work and should have the same work RVU. Thus, the same rationale that we used to value CPT codes 32096 and 32097 applies to CPT code 32100. We continue to believe that the work associated with 32100 is similar in terms of ph ysician time and intensity to CPT c ode 44300. In addition, we agree with the specialty society and AMA RUC’s assertion th at CPT code 32100 should be valued the same as CPT codes 32096 and 32097. Furthermore, we continue to believe that a work RVU of 17.00 overstates the increase in work between deleted CPT code 320 95 and its replacement CPT codes. Thus, we maintain that the interim final work RVU of 13.75 is still appropriate. After consideration of the public comments, refinement panel results, and our clinical review, we are assigning a work RVU of 13.75 as the final value for CY 2013 for CPT code 32100. We assigned a work RVU of 15.75 for CPT code 32505 (Thoracotomy; with therapeutic wedge resection (eg, mass, nodule), initial) on an interim final basis in the CY 2012 final rule414 with comment period (76 FR 73194). We noted th at after clinical re view of CPT code 32505, we believed a work RVU of 15.75 accurately reflect ed the work associated with this service compared to other related servic es. After reviewing the survey results, comparing the code to other services, the AMA RUC recommended the survey 25th percentil e work RVU of 18.79. We explained that we assigned the interim final work RVU of 15.75 in recognition of the greater physician work and intensity involved in CPT 32505 as compared to CPT code 32096. We valued the additional 30 minutes of intra-serv ice work associated with CPT code 32505 at 2.00 work RVUs. Accordingly, we assigned a work RVU of 15.75 for CPT code 32505 on an interim final basis for CY 2012.
Comment: Commenters stated that they entirely disagreed with the methods used to value CPT code 32096 and therefore, di sagreed with the value assigne d to 32505 that was based upon the value assigned to CPT code 32096. Commenters said that the methods used for valuing CPT code 32505 have never been employed to determine a code’s work value. Further, commenters explained that our value resu lts in an IWPUT of 0.06, whic h is lower than the AMA RUC recommendation. Commenters recommended we value CPT code 32505 based upon the AMA RUC-recommended work RVU of 18.79 for this c ode and requested refinement panel review. Response: Based on comments received, we referred CPT code 32505 to the CY 2012 multi-specialty refinement panel for further review. We determined that the refinement panel median work RVU of 18.79 was relatively high in re lation to the other code s in the family. We maintain that the incremental difference between CPT code 32096 and CPT code 32505 is 2.00 RVUs and, therefore continue to believe that a work RVU value of 15.75 accurately reflects the value of the service. As a re sult of the refinement panel re sults, the public comments, and our clinical review, we are assi gning a work RVU of 15.75 as the final value for CPT code 32505. (8) Respiratory: Lungs and Pleura (CPT Codes 32663, 32668-32673)415 For discussion on interim final work values for CPT codes 32663, 32668 through 32673 refer to section III.M.3. of this final rule with comment period. (9) Cardiovascular: Heart and Pericardium (CPT Code 36247) In the Fourth Five-Year Review of Work (76 FR 32445), we discussed CPT code 36247 (Selective catheter placeme nt, arterial system; initial third order or more selective abdominal, pelvic, or lower extremity artery branch, within a vascular family) and proposed a CY 2012 work RVU of 6.29 and a global period change from 90 days (Major surgery with a 1-day pre-operative period and a 90-day postoperative period incl uded in the fee schedule amount) to XXX (the global concept does not apply). In the CY 2012 PFS final rule with comment period (76 FR 73132), we agreed with commenters to the Fourth Fi ve-Year Review of Work that our discussion of the global period was incorrect and should ha ve indicated a change in global period from XXX to 000 (Minor procedure-includes RVUs fo r pre- and post-operati ve procedures on the same day). We stated that, based on comment s received, we referred CPT code 36247 to the CY 2011 multi-speciality refinement panel for further review. The refinement panel median value was a work RVU of 7.00, the AMA RUC-recomme nded value. We went on to state that upon clinical review, we believed th at our proposed work RVU of 6.29 was more appropriate. We stated that we observed a signifi cant decrease in the physician times reported for this service that argue for a lower work RVU, notwithstanding th at the survey was conducted for a 0-day global period, which includes an E/M service on the same day. Therefore, we a ssigned work RVUs of 6.29 and a global period of 000 to CPT code 36247 on an interim basis for CY 2012 and invited additional public comment on this code in the CY 2012 final rule with comment period.
Comment: A commenter appreciated that we acknowle dged that we made an inadvertent error when we referred to the original global period of th e code as 90 global days rather than XXX global days. However, this commenter stated that the new 0-da y global period, which includes an E/M service on the same day, justified the refinement panel’s median value of a work RVU of 7.00. Additionally,416
commenters stated that the change from a global pe riod of XXX (global concept does not apply) to a global period of 000 (Minor procedure-includes RV Us for pre- and post-operative procedures on the same day) added additional pre-service work. Other comment ers stated that with the removal of the lower extremity intervention patients from the code, the pr ocedures now coded with this procedure are more complex and warrant an increased value. Comment ers also pointed out that the CY 2011 refinement panel median for the code was 7.00 work RVUs. Commenters requested that we accept the AMA RUC recommendation of 7.00 work RVUs for CPT code 36247. Response: Based on comments received, we re-reviewed CPT code 36247. We continue to believe that our proposed work RVU of 6.29 accura tely reflects the work associated with this service. Based on the significan t reduction in the physician intra- service time assigned to this service from 86 minutes to 60 minutes, if this CP T code had maintained a global period of XXX, we believe it would have been appropriate to reduce the work RVU below the current value of 6.29 to reflect the reduction in time. We do not be lieve that the potential increase in intensity due to the complexity of the patie nt mix counter balances the decrea se in intra-service time. We understand that this service now in cludes the work of a same day E/M visit, and we believe this additional work is accounted for by maintaini ng the current work RVU of 6.29 rather than reducing the work RVU, as would have been a ppropriate if the servic e had maintained global period of XXX. Therefore, we are finalizi ng a work RVU of 6.29 and a 000 global period for CPT code 36247. (10) Renal Angiography codes (CPT code 36251) As detailed in the CY 2012 final rule with comment period (76 FR 73196), the CPT Editorial Panel created four bundled rena l angiography services (CPT codes 36251, 36252, 36253, and 36254), effective January 1, 2012. We assigned a work RVU of 5.35 to CPT code 36251 (Selective catheter placement (first-order), main rena l artery and any accessory renal artery (s) for renal angiography, including417 arterial puncture and cathete r placement(s), fluoroscopy, co ntrast injection(s), image postprocessing, permanent recordi ng of images, and radiologic supervision and interpretation, including pressure gradient measurements when performed, and flush aortogram when performed; unilateral) on an interim final ba sis for CY 2012 based upon our clinical review of the code. The AMA RUC reviewed the survey results, compared the code to other services, and concluded that the work value for CPT code 36251 should be directly crosswalked to CPT code 31267 (Nasal/sinus endoscopy, surgical, with maxill ary antrostomy; with removal of tissue from maxillary sinus) endoscopy, surgical, with maxilla ry antrostomy; with removal of tissue from maxillary sinus), which has a work RVU of 5.45, and recommended a work RVU of 5.45 for CPT code 36251. We determined that the work associated with CPT code 36251 is closely aligned in terms of physician time and intensity with that of CPT code 52341 (Cystourethroscopy; with treatment of uret eral stricture (eg, ba lloon dilation, laser, electrocautery, and incision), which has a work RVU of 5.35. We believed crosswalking to the work RVU of CPT code 52341 appropriately accounted for the work associated with CPT code 36251. Therefore, we assigned a work RVU of 5.35 to CPT code 36251 on an interim final basis for CY 2012.
Comment: Commenters disagreed with the inter im final work RVU of 5.35 for CPT code 36251, stating that the family of CPT codes (36251, 36252, 36253, and 36254) was carefully reviewed by the AMA RUC and the rank order was appropriately esta blished by the AMA RUC recommendations. Commenters recommended CP T code 36251 should be di rectly crosswalked to CPT code 31267 as the AMA had recommended and requested that we use 5.45 work RVUs for CPT code 36251. Response: Based on the comments received, we re-reviewed CPT code 36251 and considered the commenters’ recommendation that it be directly crosswalked to CPT code 31267.418 After re-considering the crosswalk, we continue to believe that the work associated with CPT code 36251 is closely aligned in terms of physic ian time and intensity with CPT code 52341 and that crosswalking to CPT code 52341 appropriately results in a work RV U of 5.35. Therefore, we are finalizing a work RVU of 5.35 for CPT code 36251 for CY 2013. We assigned an interim final work RVU of 6.99 to CPT code 36252 (Selective catheter placement (first-order), main re nal artery and any accessory rena l artery(s) for renal angiography, including arterial puncture and catheter placemen t(s), fluoroscopy, contrast injection(s), image postprocessing, permanent recordi ng of images, and radiologic supervision and interpretation, including pressure gradient measurements when performed, and flush aortogram when performed; bilateral), for CY 2012 after clinical review. The AMA RUC reviewed the survey results, compared the code to other services, and concluded that the work value for CPT code 36252 should be directly crosswalked to CPT code 43272 (Endoscopic retrograde cholangiopancreatography (ERCP); with ablation of tumor(s), pol yp(s), or other lesion(s) not amenable to removal by hot biopsy forceps, bipo lar cautery or snare t echnique), which has a work RVU of 7.38. Although the AMA RUC reco mmended a work RVU of 7.38 for CPT code 36252, we found that the intensity of this se rvice is more similar to CPT code 58560 (Hysteroscopy, surgical; with division or resect ion of intrauterine septum (any method)), which has a work RVU of 6.99. Accordingly, we assigne d an interim final work RVU of 6.99 to CPT code 36252 for CY 2012.
Comment: Commenters stated that this family of CPT codes 36251, 36252, 36253, and 36254 were carefully reviewed by the AMA RUC, that the rank order was appropriately established based on the AMA RUC recommenda tions, and that CPT code 36252 should be crosswalked to CPT code 43272 (Endoscopic re trograde cholangiopancreatography (ERCP); with ablation of tumor(s), polyp( s), or other lesion(s) not amen able to removal by hot biopsy419 forceps, bipolar cautery or snare technique), which has a work RVU of 7.38, as the AMA recommended. Response: Based on the comments received, we re-reviewed CPT code 36252. Although commenters recommended a direct crosswalk to CPT code 43272, we continue to believe that the work of the services is si milar to the reference CPT code 58560. Accordingly, we find that the resulting work RVUs of 6.99 is still appropriate and accounts for the work associated with this service and we are finalizing a work RVU value of 6.99 for CPT code 36252. (11) IVC Transcatheter Proce dures (CPT codes 37192 and 37193) As discussed in the CY 2012 final rule with comment period (76 FR 73197), for CPT code 37192 (Repositioning of intravascular vena cav a filter, endovascular a pproach inclusive of vascular access, vessel selection, and all radiological supervisi on and interpretation, intraprocedural roadmapping, and imaging guida nce (ultrasound and fluoroscopy)), we assigned a work RVU of 7.35 to CPT code 37192, with a refi nement to 45 minutes of intra-service time, on an interim final basis for CY 2012. After clinical review of CPT code 37192, we believed a work RVU of 7.35 accurately reflected the work associated with this servi ce. The AMA RUC reviewed the survey results, compared the code to other services, and conclu ded that the survey 75th percentile intra-service time of 60 minutes and the 25th percentile of work RVU of 8.00 accura tely described the physician work involved in the service. We determined that the work associated with CPT code 37192 is similar to CPT code 93460 (Catheter placem ent in coronary artery(s) for coronary angiography, including intrap rocedural injection(s) for coronary angiography, imaging supervision and interpretation; w ith right and left heart cathete rization including intraprocedural injection(s) for left ventriculography, when performed), which has a work RVU of 7.35, 48 minutes pre-service time, 50 minut es intra-service time, and 30 mi nutes post-service time. By420 comparing the times assigned to those of CP T code 93460, we determined that the survey median intra-service time of 45 minutes appropriately accounted fo r the time required to furnish the intra-service work of CPT code 37192. Theref ore, we assigned it a work RVU of 7.35, with a refinement to 45 minutes of intra-service time on an interim final basis for CY 2012. A complete listing of the times associated with this code is available on the CMS website at: www.cms.gov/PhysicianFeeSched/

. Comment: A commenter disagreed with our va luation for CPT code 37192, but did not provide information as to why the valuation wa s inappropriate. The commenter urged that we accept the AMA RUC-recommended work RVU and times. Response: After clinical re-review of CPT c ode 37192, we maintain that the work associated with CPT code 37192 is similar to CPT code 93460, which has the following times: 48 minutes pre-service, 50 minutes intra-service, and 30 minutes post-service. As a result, we continue to believe that the survey median intra-service time of 45 minutes appropriately accounts for the time involved in furnishing the intra- service work of this procedure. We believe that the crosswalk work RVU of 7.35 more appropr iately values the services furnished in this code than the AMA RUC recommended value of 8.00 RVUs. We are finalizing a work RVU of 7.35 to CPT code 37192, with a refinement to 45 mi nutes of intra-service time. A complete listing of the times associated with this code is available on the CMS website at www.cms.gov/PhysicianFeeSched/

. As discussed in the CY 2012 final rule with comment period (76 FR 73197), for CPT code 37193 (Retrieval (removal) of intravascu lar vena cava filter, endovascular approach inclusive of vascular access, ve ssel selection, and all radiological supervision and interpretation, intraprocedural roadmapping, and imaging guida nce (ultrasound and fluoroscopy)), we assigned a work RVU of 7.35 to CPT code 37193, with a refi nement to 45 minutes of intra-service time,421

on an interim final basis for CY 2012. After c linical review of CPT code 37193, we believed a work RVU of 7.35 accurately reflected the work a ssociated with this service. The AMA RUC reviewed the survey results, compared the code to other services, and concluded that the survey 75th percentile intra-se rvice time of 60 minutes and the 25th percentile of work RVU of 8.00 accurately described the physician work involved in the service. We believed that the work associated with CPT code 37193 is similar to CPT code 93460 (Catheter placement in coronary artery(s) for coronary angiogr aphy, including intraprocedural injection(s) for coronary angiography, imaging supervision and interpretation; with right and left heart catheterization including intraprocedural injectio n(s) for left ventriculography, when performed), which has a work RVU of 7.35, 48 minutes pr e-service time, 50 minutes intr a-service time, and 30 minutes post-service time. Based upon these times, we belie ved that the survey me dian intra-service time of 45 minutes appropriately accoun ted for the time required to furnish the intra-service work associated with CPT code 37193. Therefore, we assigned a work RVU of 7.35 to CPT code 37193, with a refinement to 45 minutes of intra-se rvice time, on an interim final basis for CY 2012. A complete listing of the times associated with this code is available on the CMS website

at: www.cms.gov/PhysicianFeeSched/

. Comment: Without providing more information, a co mmenter disagreed w ith the work RVUs assigned and refinement to time for CPT code 37193 and urged that we accept the AMA RUCrecommended work RVU of 8.00, and recommended time. Response: After clinical re-review of CPT code 37193, we maintain that the work associated with CPT code 37193 is similar to CPT code 93460, wh ich has the following times: 48 minutes pre-service, 50minutes intra-service, and 30 minutes post-service. We continue to believe that the survey median intraservice time of 45 minutes appropriately accounted for the time required to furnish the intra-service work of this CPT code 37193 rather than the AMA RU C-recommended intra-service time of 60 minutes. We also continue to believe that the work RVU of 7. 35 more appropriately values the services furnished in422

this code than the AMA-recommended work RVU of 8. 00. Therefore, we are finalizing a work RVU of 7.35 to CPT code 37132, with a refinement to 45 minut es of intra-service time. A complete listing of the times associated with this code is available on the CMS website at: www.cms.gov/PhysicianFeeSched/

. (12) Hemic and Lymphatic Systems: General, Bone Marrow or Stem Cell Services/Procedures (CPT codes 38230 and 38232) On an interim final basis, we assigned a work RVU of 3.09 to CPT codes 38230 (Bone marrow harvesting for transplantation; alloge neic) and 38232 (Bone marrow harvesting for transplantation; auto logous) for CY 2012 (76 FR 73197). In the CY 2012 final rule with comment period we noted that for CY 2012, the CPT Editorial Panel split CPT code 38230 into two separate CPT codes: 38230 and 38232 to more accu rately reflect current medical practice. We noted that we changed the global peri od from 010 to 000 for CPT code 38230, and assigned a global period of 000 to CPT code 38232, as th ese services rarely required overnight hospitalization and physician follow-up in the days following the procedure.
We noted that after clinical review of CPT c odes 38230 and 38232, we believed that a work RVU of 3.09 appropriately accounted for the work associ ated with these services. The AMA RUC reviewed the survey results and, after comparison to simi lar CPT codes, the AMA RUC recommended the survey median work RVU of 4.00 for CPT code 38230, and the survey median work RVU of 3.50 for CPT code 38232. Notwithstanding the AMA-RUC recommendation, we noted that the work for these services is very similar and should be valued the same. In CY 2011, CPT code 38230 had a work RVU of 4.85 with a ten-day global period that included a CPT code 99 213 (Level 3 office or outpatient visit, established patient), and a CPT code 99238 (disch arge day management service). We explained that we considered converting the value of CPT code 38230 from a 10- day global period to a 0-day global period by subtracting the work RVUs for CPT code 99213 (work RVU=0.97) and CPT code 99238 (work RVU=1.28), but believed that the resulting work RVU of 2.60 would result in this code being valued too low compared to other similar services. Instead , we found that the CPT code 38230 survey 25th percentile work RVU of 3.09 accurately captured the intensity of this service with the revised global423
period. Therefore, we assigned a work RVU of 3.09 to CPT code 38230 on an interim final basis for CY 2012. Since, as explained above, we believed that CPT code 38232 should have the same work RVU as CPT code 38230, we also assigned a work RVU of 3.09 to CPT code 38230 on an interim final basis for
CY 2012. Comment: Commenters acknowledged that the intra-service times of CPT codes 38230 and 38232 are similar; however, they stated th at the service descri bed by CPT code 38230 is typically more intense and stre ssful since it is being performe d on a donor, who does not directly benefit from the procedure. Commenters also noted that collecting donor cells is typically prolonged to ensure that enough cel ls have been collected. Comme nters stated that although the survey did not reflect the intra-service time for CPT code 38230, the AMA RUC-recommended values appropriately accounted for the lower ti me reported in the surv ey with a higher work RVU value. Additionally, commenters stated th at the reverse buildi ng block methodology was an inappropriate policy to apply to any services with changing global day periods and in this case, particularly inappropriate b ecause the post-operative visits buil t into the code were initially valued by the Harvard study several years ago. Given these arguments, commenters requested the AMA RUC recommended work RVUs of 4.0 0 for CPT code 38230 and 3.50 for CPT code 38232 be used to value these codes and requested refinement panel review of these codes. Response: Based on comments received, we referr ed CPT codes 38230 and 32832 to the CY 2012 multi-specialty refinement panel for further revi ew. The refinement panel median work RVU for CPT code 38230 was 4.00, and the median work RVU for CPT code 38232 was 3.50. We continue to believe that CPT codes 38232 and 38230 require the same amount of physician work and should be valued the same. After reviewing the public comment s and the refinement panel ratings, we agree that the refinement panel median work RVU of 3.50 for CPT code 38232 more appropriately reflects the work of CPT codes 38230 and 38232 than the interim final work RVU of 3.09. We believe the refinement panel median work RVU of 4.00 fo r CPT code 38230 overstates the work associated with these services,424
especially considering that for CPT code 38230 the survey 25 th percentile work RVU was 3.09 and a building block methodology based on the CY 2011 work RVU and global period yielded work RVU of 2.60 for this service. As a result of the refinement panel ratings, the public comments, and our clinical review, we are finalizing a work RVU of 3.50 for CPT codes 32830 and 32832. (13) Digestive: Abdomen, Peritone um, and Omentum (CPT code 49084) As detailed in the CY 2012 final rule with comment period (76 FR 73198), the CPT Editorial Panel deleted CPT codes 49080 a nd 49081and created three new CPT codes, 49082, 49083, and 49084, effective January 1, 2012, to more accurately describe the current medical practice. After clinical review, we assigned a work RVU of 2.00 to CPT codes 49083 (Abdominal paracentesis (diagnostic or therapeutic); with imagi ng guidance) and 49084 (Peritoneal lavage, including imaging guidance, when performed) on an inte rim final basis for CY 2012. The AMA RUC recommended a work RVU of 2.00 for CPT code 49083 and a work RVU of 2.50 for CPT code 49084. We agreed with the AMA RUC-reco mmended work RVU of 2.00 for CPT code 49083, but disagreed that CPT 49084 should be valued more. Instead, we belie ved that CPT code 49084 requires similar work to code 49083 and should be valued the same. Therefor e, we assigned a work RVU of 2.00 to CPT codes 49083 and 49084 on an interim final basis for CY 2012.
Comment: One commenter disagreed with our valua tion of CPT code 49084 and the resulting work RVU recommendation but did not describe why. Response: After clinical re-review of CPT code 49084 , we continue to believe that CPT code 49084 requires similar work as CPT code 49083 and shoul d be valued the same. Accordingly, we are finalizing a work RVU of 2.00 for CPT codes 49083 and 49084. (14) Nervous: Spine and Spinal Cord (CPT Codes 62370) CPT code 62370 (Electronic analysis of progr ammable, implanted pump for intrathecal or epidural drug infusion (include s evaluation of reservoir status , alarm status, drug prescription status)); with reprogramming and refill (requir ing physician's skill)) newly created by the CPT425 Editorial Panel for CY 2012, was assigned an in terim final work RVU of 0.90 for CY 2012 as discussed in the CY 2012 final rule w ith comment period (76 FR 73199). As we noted in the CY 2012 final rule with comment period, after clinical review of CPT code 62370, we believed that a work RVU of 0.90 accurately accounted for the work associated with this service. We noted that after a comparison to similar services, the AMA RUC recommended a work RVU of 1.10 for CPT code 62370 based on a crosswalk to CPT code 56605 (Biopsy of vulva or perineum (separate pro cedure); 1 lesion) however, we believed that a work RVU of 1.10 for CPT code 62370 was too high comp ared to similar services in this family. Instead, we found CPT code 62370 to be similar in intensity and complexity to CPT code 93281 (Programming device evaluation (in person) with iterative adjustme nt of the implantable device to test the function of the device and select optimal permanent programmed values with physician analysis, review and report; multiple le ad pacemaker system), which has a work RVU of 0.90. We noted that this value, which is be tween the specialty societ y survey 25th percentile and median work RVU, appropriately reflected the work of CPT code 62370. Therefore, we assigned a work RVU of 0.90 to CPT code 62370 on an interim final basis for CY 2012.
Comment: Commenters disagreed with the valu e, explaining that CPT code 93281 was not an appropriate crosswalk because it was a programming only code while CPT code 62370, is a procedure and programming code. Commenters noted that the interim final work RVU of 0.90 does not account for the work in refilling the pum p, which requires a sterile puncture in a patient whose complexities preclude provision of these services by a nonphysician. Therefore, commenters requested that CPT code 62370 be valued based upon the AMA RUC recommended value of 1.10 work RVUs and requested re finement panel review of this code. Response: Based on comments received, we referred CPT code 62370 to the CY 2012 multi-specialty refinement panel for further review . The refinement panel median work RVU for426 CPT code 62370 was 1.10. In subsequent review, we determined that valuing this code at the refinement panel median work RVU value would re sult in too high a value as compared to the other codes in the family. CPT code 62369 (Ele ctronic analysis of programmable, implanted pump for intrathecal or epidural drug infusion (includes evalua tion of reservoir status, alarm status, drug prescription status); with reprogramming and refill) has a work RVU of 0.67. CPT code 62369 describes the same procedure as CPT code 62370, except in CPT code 62369 the reprogramming and refill doe s not require physician ski ll and in CPT code 62370 the reprogramming and refill does require physician sk ill. We believe a work RVU of 0.90 for CPT code 62370 reflects the appropriate incremental in crease in physician work for reprogramming and refill by a physician, versus a nonphysician. We also continue to believe that CPT code 93281, which was recently reviewed, has similar intensity and complexity to CPT code 62370, and that CPT codes 93281 and 62370 include the same amount of intra-se rvice physician time. We believe that CPT codes 93281 and 62370 involve the same amount of physician work and maintain that a work RVU of 0.90 appropriately capt ures the physician work of these procedures. After reviewing the public comments, the refineme nt panel ratings, and our clinical review, we are finalizing a work RVU of 0.90 as for CPT code 62370. (15) Diagnostic Radiology: Abdomen (CPT Codes 74174) For discussion on CY 2013 interim final work values for CPT code 74174 refer to section III.M.3. of this final rule with comment period. (16) Pathology and Laboratory: Ur inalysis (CPT Codes 88120 and 88121) For discussion on CY 2013 interim work values for CPT codes 88120-88121, refer to section III.M.3. of this fina l rule with comment period. (17) Psychiatry: Psychiatric Therapeu tic Procedures (CPT codes 90845 and 90869) For discussion on interim work values for CPT codes 90845 and 90869, refer to section427 III.M.3. of this final rule with comment period. (18) Ophthalmology: Special Ophthalm ological Services (CPT codes 92071) As detailed in the CY 2012 final rule with comment period (76 FR 73202), for the Fourth Five-Year Review, we identified CPT code 92070 through the Harvard-Valued--Utilization over 30,000 screen as a potentially misvalued code. U pon review of this service, the CPT Editorial Panel deleted CPT code 92070 and created two new CPT codes (92071 and 92072) to distinguish reporting of fitting of contact lens for treatment of ocular surface disease and fitting of contact lens for management of keratoconus. We assigned an interim final work RVU of 0.61, with refinement to time as noted above to CPT code 92071 (Fitting of cont act lens for treatment of ocul ar surface disease) for CY 2012. We determined that CPT code 92071 is expected to capture the utilizatio n of the deleted code CPT code 92070 (Fitting of contact lens for treatment of disease, including supply of lens). Since CPT code 92070 was typically billed with an E/M service on the same day, we believed that CPT code 92071 would also ty pically be billed with an E/M service on the same day. We concluded that some of the activities conducte d during the pre- and pos t-service times of the procedure code and the E/M visi t overlapped and, ther efore, should not be counted twice in developing the procedure's work value. To account for this overlap, we reduced the pre-service evaluation time and post-service time by one-third each. Specifically, we reduced each the preservice evaluation time and the pos t-service time from 5 minutes to 3 minutes. To determine the appropriate work RVU for CPT code 92071, we calcu lated the value of the extracted time and subtracted it from the AMA RUC-recommende d work RVU of 0.70, which equals the CY 2011 work RVU for the deleted code, CPT 92070. In valuing CPT code 92071, we removed a total of 4 minutes (as described above) at an intens ity of 0.0224 per minute, which amounted to the removal of 0.09 work RVUs. Therefore, we a ssigned an interim final work RVU of 0.61, with428

refinement to time as noted above to CPT c ode 92071 for CY 2012. A complete listing of the times associated with this code is available on the CMS website at: www.cms.gov/PhysicianFeeSched/

. Comment: Commenters disagreed with the rationale used to lower the value for CPT code 92071 and further disagreed with the reverse building block methodology used. Commenters stated that the AMA RUC and the affected specialty society had reviewed and valued CPT code 92071 with the assumption that an E/M service would be billed in conjunction with the service and cited the AMA summary of recommendations as evidence. Therefore, none of the pre- and post-time allocated to this code overlapped with the E/M service. They pointed out that the AMA RUC-recommended work RVU of 0.70 was lower than the survey median work RVU of 1.11. Commenters preferred th e AMA RUC comparison of CPT code 92071 to CPT code 65205 (Removal of foreign body, external eye; conjunctival superf icial) with a work RVU of 0.71 and noted that both services have identical physician time components and should be valued similarly. Therefore, commenter s requested the AMA RUC recommended work RVU of 0.70 and the AMA RUC recommended pre-servi ce and immediate post-se rvice physician time of 5 minutes, each. Response: After clinical re-review, we continue to believe that the reverse building block methodology is an appropriate way to value the service s described by CPT code 92071. We maintain that some of the activities conducted during the pre- and po st-service times of the procedure code and the E/M visit overlap and, therefore, should not be counted tw ice in developing the procedure's work value. To account for the overlap in work between CPT code 92071 and the same day E/M service, the AMA RUC removed 2 minutes pre-service time from the pre-service package time of 7 minutes. We believe that the pre-service package overstates the time involved in th is procedure and that a more appropriate starting point for the same day E/M reduction for this proce dure is the survey median pre-service time. We believe that removing 2 minutes of pre-service time from the survey median pre-service time of 5429
minutes, as well as 2 minutes from the post-service time of 5 minutes better reflects the time involved in furnishing the work of this procedure alongside an E/ M service. We continue to believe that a work RVU of 0.61 accurately reflects the work of the service relativ e to similar services. Therefore, we are finalizing a refinement to time and a work RVU of 0.61 for CP T code 92071. The times assigned to this CPT code are available on the CMS website at: www.cms.gov/PhysicianFeeSched/

. (19) Special Otorhinolaryngologic Services: Au diologic Function Tests (CPT codes 92587 and 92588) On an interim final basis for CY 2012, we assigned a work RVU of 0.35 to CPT code 92587 (Distortion product evoked otoacoustic em issions; limited evaluation (to confirm the presence or absence of heari ng disorder, 3-6 frequencies) or transient evoked otoacoustic emissions, with interpretation and report) as de tailed in the CY 2012 fina l rule with comment period (76 FR 73202). We identified CPT code 92587 as a potentially misvalued code through the Fastest Growing screen. The specialty soci ety surveyed this service to create a new recommendation for CY 2011. However, after review ing the survey data, it concluded that more than one service is represented by this code a nd requested the service be referred back to the CPT Editorial Panel for further clarification. As a result, the CPT Edito rial Panel created CPT code 92558 (Distortion product evoked otoacous tic emissions; comprehensive diagnostic evaluation (quantitative analysis of outer hair cell function by cochlear mapping, minimum of 12 frequencies), with interpretation and report) to describe evoked otoacoustic emissions screening, and revised CPT codes 92587 and 92588 clarify th e otoaucoustic emissions evaluations, effective January 1, 2012. After clinical review of CPT code 92587, we believed that the survey 25th percentile work RVU of 0.35 accurately descri bed the work associated with this service. The HCPAC reviewed the survey results, and after a comparison to similar CPT codes, recommended a work RVU of 0.45 for CPT c ode 92587, which was between the survey 25th percentile and median values. We believed that CPT code 92587 was similar in time and430 intensity to CPT code 97124 (Thera peutic procedure, 1 or more areas, each 15 minutes; massage, including effleurage, petrissage and/or tapote ment (stroking, compression, percussion)), which has a work RVU of 0.35, and that the survey 25 th percentile value appr opriately reflected the relativity of this serv ice. Therefore, we assigned a wo rk RVU of 0.35 to CPT code 92587 on an interim final basis for CY 2012.
Comment: Commenters disagreed with the interim fi nal work RVU of 0.35 and urged CMS to use the HCPAC recommendation of 0.45 since it is between the survey 25th percentile and median values. Commenters stated that although 25th per centile might be reasonable in situations where the accuracy of the survey data is in doubt, in this case the overall distribution of the data, the size of the sample, and response rate made the median a better guide. Commenters noted the importance of cross specialty comparisons, but stated that a crosswalk to CPT code 97124 was not appropriate. Commenters stated that CPT code 92587 is a cognitive diagnostic service that requir es the audiologist to review and interpret data resulting from numerous tonal pair sa mples administered to a patient’s inner ear whereas CPT code 97124 is a therapeutic service involving hands-on manipulation of tissue and muscles. As a result, a more appropriate comparison code listed w ithin the physical therapy section is the cognitive diagnostic work required to perform CPT code 97001 (Physical Therapy Evaluation), which has a work RVU of 1.20 and an intra-service time of 30 minutes. Commenters stated that it was, therefore, comparable to the requested 0.45 for 12 minutes of intra-service work for CPT code 92587. Commenters requested that we accept the HCPAC-recommende d work RVU of 0.45 for CPT code 92587 and requested refinement panel review of the code. Response: Based on comments received, we refe rred CPT code 92587 to the CY 2012 multispecialty refinement panel for further review. Th e refinement panel median value for CPT code 92587 was a work RVU of 0.45. We note that prior to our assignment of interim final work RVUs for CY 2012, CPT code 92587 had a work RVU of 0.13 because the wo rk of this service was captured in the practice expense RVU as clinical labor, rather than in th e work RVU as professional work. For CY 2012, the work of this service was moved from the PE RVU to th e work RVU. In re-valuing the service to reflect431
this shift, we believe the survey 25th percentile work RVU of 0.35 captured the intensity of the professional work. While CPT codes 97124 and 92587 describe different services, we believe they involve the same time and have a very similar level of intensity and complexity and therefore should be valued the same. After consideration of the public comments, refinement panel results, and our clinical review, we are finalizing a work RVU of 0.35 for CPT code 92587. On an interim final basis for CY 2012, we assigned a work RVU of 0.55 to CPT code 92588 (Distortion product evoked otoacoustic em issions; comprehensive diagnostic evaluation (quantitative analysis of outer hair cell function by cochlear mapping, minimum of 12 frequencies), with interpretation and report) (76 FR 73202). After clinical review of CPT code 92588, we believed that the survey 25th percent ile work RVU of 0.55 accurately described the work associated with this service. The HC PAC reviewed the survey results, and after a comparison to similar CPT codes, recommended th e survey median work RVU of 0.62 for CPT code 92588. We believed that CPT code 92588 is similar in work to CPT code 92570 (Acoustic immittance testing, includes tympanometry (imped ance testing), acoustic reflex threshold testing, and acoustic reflex decay testing) , which ha s a work RVU of 0.55, and that the survey 25th percentile work RVU of 0.55 appropriately reflected the relativity of this service. Therefore, we assigned a work RVU of 0.55 to CPT code 92588 on an interim final basis for CY 2012.
Comment: Commenters agreed with us that CPT code 92588 involves a higher level of professional work and should be valued incremen tally higher than CPT code 92587. However, commenters disagreed with the interim final work RVU values and believe the services furnished under the code involve a greater degree of professional work . Commenters stated that CPT code 92570 is not an appropriate comparison code because it is a bundled code that includes three different audiology tests, acoustic reflex threshold testing and acoustic reflex decay, as current ly represented individually by CPT codes 92567 and 92568. As a bundled service, the wo rk RVU for 92570 was reduced below the level of the combined services to account fo r efficiencies involved in conducting the three tests together.432
Commenters noted it is not appropriate to compare a bundled service, for which the work RVU has been reduced, with a test intended to evaluate overall outer hair cell function, using a minimum of 12 frequencies. Therefore, commenters requested the code be reviewed by the refinement panel. Response: Based on comments received, we refe rred CPT code 92588 to the CY 2012 multispecialty refinement panel for further review. Th e refinement panel median value for CPT code 92588 was a work RVU of 0.60. We note that prior to our assignment of interim final work RVUs for CY 2012, CPT code 92588 had a work RVU of 0.36 because the wo rk of this service was captured in the practice expense RVU as clinical labor, rather than in th e work RVU as professional work. For CY 2012, the work of this service was moved from the PE RVU to th e work RVU. In re-valuing the service to reflect this shift, we believe the survey 25th percentile work RVU of 0.55 captured the intensity of the professional work. While CPT codes 92570 is a bundl ed service, we believe CPT codes 92570 and 92588 involve very similar time and intens ity and should be valued the same. Furthermore, we believe a work RVU of 0.55 for CPT code 92588 reflects the appropria te incremental difference over the work RVU of 0.35 for CPT code 92587. After consideration of th e public comments, refinement panel results, and our clinical review, we are finalizing a work RVU of 0.55 for CPT code 92588. (20) Cardiovascular: Cardiac Ca theterization (CPT codes 93451-93568) For CY 2012, we assigned the following inter im final work RVUs for the following CPT codes: 2.72 for CPT code 93451 (Right heart ca theterization includi ng measurement(s) of oxygen saturation and cardiac output, when pe rformed), 4.75 for CPT code 93452 (Left heart catheterization including intrap rocedural injection(s) for le ft ventriculography, imaging supervision and interpretation, when performed), 6.24 for CPT code 93453 (Combined right and left heart catheterizati on including intraprocedural injection(s) for left ventriculography, imaging supervision and interpretati on, when performed), 4.79 for CP T code 93454 (Catheter placement in coronary artery(s) including intraprocedural injection(s) fo r coronary angiography, imaging supervision and interpretation), 5.54 for CPT code 93455 (with catheter placement(s) in bypass graft(s) (internal mammary, free ar terial, venous grafts) including in traprocedural injection(s) for433 bypass graft angiography with cathe ter placement(s) in bypass gr aft(s) (internal mammary, free arterial, venous grafts) includi ng intraprocedural injection(s) for bypass graft angiography), 6.15 for CPT code 93456 (Catheter placement in co ronary artery(s) incl uding intraprocedural injection(s) for coronary angi ography, imaging supervision and interpretation with right heart catheterization), 6.89 for CPT code 93457 (Cathete r placement in coronary artery(s) including intraprocedural injection(s) for coronary a ngiography, imaging supervis ion and interpretation with catheter placement(s) in bypass graft(s) (internal mammary, free arterial, venous grafts) including intraprocedural injection(s) for bypass graft angiography and right heart catheterization), 5.85 for CPT code 93458 (Cathete r placement in coronary artery(s) including intraprocedural injection(s) for coronary a ngiography, imaging supervis ion and interpretation with left heart catheterization including intraprocedural injecti on(s) for left ventriculography, when performed), 6.60 for CPT code 93459 (Cathete r placement in coronary artery(s) including intraprocedural injection(s) for coronary a ngiography, imaging supervis ion and interpretation with left heart catheterization including intraprocedural injecti on(s) for left ventriculography, when performed, catheter placement(s) in bypass graft(s) (internal ma mmary, free arterial, venous grafts) with bypass graft angiography), 7. 35 for CPT code 93460 (Catheter placement in coronary artery(s) including intraprocedural injection(s) for coronary angiography, imaging supervision and interpretation wi th right and left heart cathete rization including intraprocedural injection(s) for left ventri culography, when performed), 8.10 for CPT code 93461 (Catheter placement in coronary artery(s) including intrapro cedural injection(s) for coronary angiography, imaging supervision and interpretation with ri ght and left heart catheterization including intraprocedural injection(s) for left ventriculo graphy, when performed, catheter placement(s) in bypass graft(s) (internal mammar y, free arterial, venous grafts) with bypass graft angiography), 1.11 for CPT code 93563 (Injection procedure duri ng cardiac catheteriza tion including image434 supervision, interpretation, a nd report; for selective corona ry angiography during congenital heart catheterization) , 1.13 for CPT code 93564 (Inject ion procedure during cardiac catheterization including image s upervision, interpretation, and re port; for selective coronary angiography during congenital hear t catheterization for selective opacification of aortocoronary venous or arterial bypass graft(s) (eg, aortocoronary saphenous ve in, free radial artery, or free mammary artery graft) to one or more coronary arte ries and in situ arterial conduits (eg, internal mammary), whether native or used for bypass to one or more coronary ar teries during congenital heart catheterization, wh en performed), 0.86 for CPT code 93565 (Injection procedure during cardiac catheterization including image supervision, interpre tation, and report; for selective coronary angiography during congenita l heart catheterization for select ive left ventricular or left arterial angiography), 0.86 for CPT code 93566 (Injection pro cedure during cardiac catheterization including image s upervision, interpretation, and re port; for selective coronary angiography during congenital heart catheterization for selective right ventricular or right atrial angiography), 0.97 for CPT code 93567 (Injectio n procedure during cardiac catheterization including image supervision, in terpretation, and report; for se lective coronary angiography during congenital heart catheteri zation for supravalvular aortography), and 0.88 for CPT code 93568 (Injection procedure duri ng cardiac catheteri zation including image supervision, interpretation, and report; for selective coronary angi ography during congenital heart catheterization for pulmonary angiography). As discussed in the CY 2011 final rule with comment period, the AMA RUC provided CMS with recommendations for several categories of new diagnostic cardiac catheteri zation services codes that pr eviously were reported under multiple component codes. These AMA RUC -recommended values for the comprehensive diagnostic cardiac catheterization co des did not appear to reflect th e efficiencies in work and/or PE that occur when component services are furnished together. The AMA RUC generally435

recommended the lower of either the sum of the current RVUs for the component services or the specialty society survey 25th perc entile value for the comprehens ive cardiac catheterization. In most cases, the AMA RUC's recommendation for the comprehensive service was actually the sum of the current work RVUs for the component services, and we stat ed in the CY 2011 final rule with comment period that we were unsure ho w this approach is resource-based with respect to physician work. As we noted in the CY 2011 fi nal rule with comment period, in valuing these comprehensive services, we used a conservative estimate of 10 percent for the work efficiencies we would expect to occur when multiple compon ent cardiac catheterizat ion services are bundled together. In the CY 2011 final rule with co mment period, we requested that the AMA RUC reexamine the cardiac catheterization codes. As discussed in the CY 2012 final rule with comment period (76 FR 73202), the AMA RUC reviewed these codes again for CY 2012 an d reiterated its previous recommendations, maintaining that there are negligible work effici encies gained in the bund ling of these services. However, we continued to believe that there wo uld be efficiencies when these services are performed together that should be reflected in the values assigne d. In lieu of a more specific estimate from the AMA RUC, and using the best information available to us at the time, we noted that we believed it was appropriate to assign as interim final for CY 2012 the AMA RUC CY 2011 recommendation with a 10 percent reduction in work to reflect the efficiencies described above.
Comment: Commenters noted that at CMS’ s second request, the AMA RUC workgroup reviewed significant documentati on of the valuation and coding hi story of the codes and after this extensive review, st ill found the original work value r ecommendations for these codes to be appropriate. Commenters stated th at maintaining the diagnostic ca theterization codes at their CY 2011 work RVU levels is arbitrary and th at instead we should accept the AMA RUC436

recommendation for these new set of code s for diagnostic cardiac catheterization. Response: Based on the comments we received, we re-reviewed the cardiac catheterization codes (CPT codes 93451 through 93568). We appreciate that the AMA RUC reviewed the code set again; however, we still maintain that there are work effici encies gained in the bundling of these services, and all services. The AMA RUC used a variety of methodologies in developing RVUs for the comprehensive services reviewed for CY 2012. The AMA RUC-reco mmended RVUs for the comprehensive codes for diagnostic cardiac catheterization were an average of only one percent lower than the original component codes. Given that the AMA RUC recommendations for the bundling of endovascular revascularization and CT codes resulted in average reductions in the R VUs of 27 percent and 25 percent, respectively, we continue to believe an approximation of work efficiencies garnered through the bundling of the component codes could be as high as 27 percent. Thus, in the absence of more precise information, we believe that a 10 percent reduction in the AMA RU C-recommended work RVUs is an appropriate and conservative approximation of these efficiencies. Ther efore, we are finalizing the CY 2012 interim final values for the cardiac catheterization codes as the fi nal work RVU values for CY 2013. Specifically, we are finalizing the following work RVUs for the follo wing CPT codes: a work RVU of 2.72 for CPT code 93451; a work RVU of 4.75 for CPT code 93452; a work RVU of 6.24 for CPT code 93453; a work RVU of 4.79 for CPT code 93454; a work RVU of 5.54 for CPT code 93455; a work RVU of 6.15 for CPT code 93456; a work RVU of 6.89 for CPT code 93457; a work RVU of 5.85 for CPT code 93458; a work RVU of 6.60 for CPT code 93459; a work RVU of 7.35 for CPT code 93460; a work RVU of 8.10 for CPT code 93461; a work RVU of 1.11 for CPT code 93563; a work RVU of 1.13 for CPT code 93564; a work RVU of 0.86 for CPT code 93565; a work RVU of 0.86 for CPT code 93566; a work RVU of 0.97 for CPT code 93567; and a work RVU of 0.88 for CPT code 93568. (21) Pulmonary: Other Procedures (CPT Codes 94060, 94726-94729) CPT code 94060 (Bronchodilation responsiveness, spirometry as in 94010, pre- and postbronchodilator administration) was assigned an interim final work RVU of 0.26 in the CY 2012 final rule with comment period (76 FR 73206). After CPT code 94060 was identified for review437 because it was on the Multispecialty Points of Comparison List, and also was identified as potentially misvalued through Codes Reported T ogether 75 percent or More screen, the CPT Editorial Panel reviewed the code and cr eated CPT codes 94060, 94726 (Plethysmography for determination of lung volumes and, when perfor med, airway resistance), 94727 (Gas dilution or washout for determination of lung volumes and, when performed, distribution of ventilation and closing volumes), 94728 (Airway resistance by impulse oscillometry), and 94729 (Diffusing capacity (eg, carbon monoxide, me mbrane) (List separately in addition to code for primary procedure)). For CY 2012, the CPT Editorial Panel also created CPT codes 94780 and 94781 to report car seat testing admini stered to the patient in the private physician's office. For CY 2012, we assigned a work RVU of 0.26 to CPT codes 94060, 94726, 94727, and 94728 on an interim final basis (76 FR 73206). Afte r clinical review, we determined that CPT codes 94060, 94726, 94727, and 94728, involve similar wo rk and should have the same work RVUs. We noted that CPT code 94240 (Functiona l residual capacity or residual volume: helium method, nitrogen open circuit method, or other method) (work RVU=0.26) was deleted and the utilization associated with th at service would be captured un der the CPT codes 94726 and 92727. We also noted that we believed that a work RVU of 0.26 appropriately reflected the work associated with CPT codes 94060, 94726, 94727, and 94728 and that the AMA RUC had recommended the same work RVU (0.31) for a ll four codes, based upon each survey’s 25th percentile work RVU. We expl ained that this value was further supported by CPT code 97012 (Application of a modality to 1 or more areas; traction, mechani cal), which has a work RVU of 0.25) and which had similar time and intensity. Therefore, we assigned a work RVU of 0.26 to CPT codes 94060, 94726, 94727, and 94728 on an interim final basis for CY 2012.
Comment: Commenters disagreed with the work RVU assignments for these codes and stated that CPT code 94375 (Respiratory flow volume loop), which has a work RVU of 0.31, is438 the appropriate reference code , as the AMA RUC recommende d. Although CPT code 94375 has more intra-service time (7 minut es compared to 5 minutes), th e survey respondents rated the surveyed codes as more intense and complex than the reference code. Commenters stated that the appropriate value for the level of physician work involved in CPT codes 94060, 94726, 94727, and 94728 is 0.31 work RVUs. Therefore, co mmenters urged that we value CPT codes 94060, 94726, 94727, and 94728 based upon the AMA RUC-recommended work RVU of 0.31 and requested these codes be reviewed by the refinement panel. Response: Based on comments received, we referred CPT codes 94060, 94726, 94727, and 94728 to the CY 2012 multi-specialty refinement panel for further review. The refinement panel median work RVUs for the CPT codes were 0.27, 0.26, 0.26, and 0.26, respectively. As a result of the refinement panel ratings and our clinical review, we are assigning a work RVU of 0.27 as the final value for CPT code 94060 and 0.26 work RVUs as the final value for CPT code 94726, 94727, and 94728. After clinical review of CPT code 94729 (Diffusing capacity (eg, carbon monoxide, membrane) (List separately in addition to code fo r primary procedure)), we believed that a work RVU of 0.17 accurately reflected the work associat ed with this service. Based on a comparison to similar services, the AMA RUC recommended a work RVU of 0.19. We believed that CPT code 94010 (Spirometry, including gr aphic record, total and timed v ital capacity, expiratory flow rate measurement(s), with or without maximal vo luntary ventilation), which has a work RVU of 0.17, was similar in time and intensity to CPT code 94729, and that the codes should have the same work RVUs. Therefore, we assigne d a work RVU of 0.17 to CPT code 94729 on an interim final basis for CY 2012.
Comment: Commenters disagreed that CPT code 94010 was similar in time and intensity to CPT code 94729, explaining that the serv ice furnished under CPT code 94010, simple439 spirometry, is considered the foundation of pulmo nary function testing and does not involve the same physician work as services furnished under CPT code 94729 a diffusing capacity including the membrane. Commenters suggested that the AMA RUC-recommended crosswalk code 93352 (Use of echocardiographic cont rast agent during stress echocar diography), which has a work RVU of 0.19 has identical physic ian time of 5 minutes and comp arable physician work and intensity to CPT code 94729. Commenters requ ested that we value the code based upon the AMA RUC-recommended work RVU of 0.19 for CP T code 94729 and requested this code be reviewed by the refinement panel. Response: Based on comments received, we referred CPT code 94729 to the CY 2012 multi-specialty refinement panel for further review . The refinement panel median work RVU for CPT code 94729 was 0.19. As a result of the refine ment panel ratings and our clinical review, we are finalizing a work RVU of 0.19 for CPT code 94729. Furthermore, for CY 2013, we received no public comments on the CY 2012 interim final work RVUs for CPT codes 94780 and 94781. We believe these values continue to be appropriate and are finalizing them without modification. (22) Neurology and Neuromuscular Procedures : Autonomic Function Tests (CPT Codes 95938- 95939) For discussion on interim work values for CPT codes 95938 and 95939, refer to section III.M.3. of this final rule with comment period. (23) Central Nervous System Assessments/ Tests (CPT codes 96110, HCPCS code G0451) For CY 2012, the CPT Editorial Panel revised CPT code 96110 (Developmental screening, with interpretation and report, per standardiz ed instrument form) to reflect current practice and avoid use of inaccurate terms associ ated with this code. For CY 2012 we created HCPCS code G0451 (Development testing, with in terpretation and report, per standardized440 instrument form) to replace CPT code 96110, which is discussed in the CY 2012 final rule with comment period (76 FR 73265). In the CY 2012 fi nal rule correction notice (77 FR 227), we noted that the discussion of CPT codes 96110 and G0451 was omitted from the CY final rule with comment period due to an inadvertent error, and we incl uded our intended discussion in subsequent the correction notice. Additionall y, we corrected the PFS status indicator in Addendum B for CPT code 96110 to N (Non-covere d service. These codes are noncovered services. Medicare payment is not made for thes e codes. If RVUs are shown, they are not used for Medicare payment.), from X (Statutory exclus ion. These codes represent an item or service that is not within the statutor y definition of “physicians' services” for PFS payment purposes (for example, ambulance services). No RVUs are shown for these codes and no payment may be made under the PFS.). The discussion and informa tion in this section reflects the changes made in CY 2012 final rule correction notice. The CPT Editorial Panel revised the long descr iptor for CPT code 96110 from (Developmental testing; limited (for example, Developmental Screeni ng Test II, Early Language Milestone Screen), with interpretation and report) to (Devel opmental screening, with interpreta tion and report, per standardized instrument form),effective January 1, 2012. With th is change, we believed that the services described by CPT code 96110 consisted of screeni ng services, and thus was not within the scope of benefits of the Medicare program, as defined by the Act. Theref ore, we assigned CPT code 96110 a PFS procedure status indicator of N. To continue to make payment under the PFS for the testing services described under CPT code 96110 prior to revision of the l ong descriptor, we created HCPCS code G0451 (Developmental testing, with interpretation and report , per standardized instrument form). To calculate resource-based RVUs for HCPCS code G0451, we crosswalked the utilization, direct practice expense inputs, and malpractice risk factor from CPT code 96110 to HCPCS code G0451. We noted in the CY 2012 final rule with comment period that CPT code 96110 did not have physician work RVUs, therefore441
no physician work RVUs had been assigned to HCPCS code G0451. The CY 2012 interim final RVUs assigned to G0451 were included in Addendum B of the CY 2012 final rule correction notice.
Comment: We received notice from many commenters that they did not believe a procedure status of X was appropriate for CPT code 96110. Commenters stated that th e change in the code description from “developmental testing; limited" to "developmental screening" should not preclude payment for this service. Additionally, other commenters raised concerns that this code is used for early developmental screening in pediatric offices and worried that our decision not to cover this code under the Medicare program would influence Medicaid coverage . Commenters recommended that this testing service should continue to be paid under the Medicare PFS. Response: We thank commenters for bringing the e rror in the status indicator for CPT code 96110 to our attention. As noted above, we corrected the PFS st atus indicator in a correction notice (77 FR 227) to N (Noncovered se rvice. These codes ar e noncovered services. Medicare payment may not be made for these codes. If RVUs ar e shown, they are not used for Medicare payment) is more appr opriate for this code . Regarding commente rs concern that the testing services previously repor ted under CPT code 96110 continue to be payable, we point out that while these service are no longer payable using CPT code 96110, they continue to be payable using HCPCS code G0451, effective Janu ary 1, 2012. We understand that our lack of discussion of these services in the CY 2012 PFS final rule with comment period may have furthered this concern. We received no public comments on the CY 2012 interim final work RVUs for HCPCS code G0451. We believe these values continue to be appropriate and are finalizing them without modification.

b. Finalizing CY 2012 Interim Direct PE Inputs i. Background and Methodology In this section, we address in terim final direct PE inputs as presented in the CY 2012 PFS442 final rule with comment period and displayed in the final CY 2012 direct PE database available on the CMS Web site under the downloads at http://www.cms.gov/PhysicianFeeSched/PFSFRN/list.asp#TopOfPage

. On an annual basis, the AMA RUC provi des CMS with recommendations regarding direct PE inputs, including clin ical labor, supplies, and equi pment, for new, revised, and potentially misvalued codes. We review the AMA RUC-recommended direct PE inputs on a code-by-code basis, including the recommended fac ility PE inputs and/or nonfacility PE inputs, as clinically appropriate for the code. We determine whether we agree with the AMA RUC’s recommended direct PE inputs for a service or, if we disagree, we refine the PE inputs to represent inputs that better reflect our estimate of the PE resources required for the service in the facility and/or nonfacility settings . We also confirm that CPT code s should have facility and/or nonfacility direct PE inputs, and make change s based on our clinical judgment and any PFS payment policies that would apply to the code. As we explained in the CY 2012 PFS final rule (76 FR 73212), we generally only establish interim final direct PE inputs for services when we rece ive direct PE input recommendations in the context of new, revised or potentially misvalued codes. However, for CY 2012, we established interim final direct PE inputs for several codes for which we did not receive direct PE recommendations. In the case of these codes, we believed it was necessary to establish new interim final direct PE inputs in order to maintain appropriate relativity among those codes and other related codes or between the PE, work and malpractice components of the PFS payment for the codes.
Comment: Several commenters stated that th ey understood CMS’ rationale for refining the direct PE inputs on an interim final basis as we explained above, but urged CMS to bring the443 AMA RUC’s attention to these codes during the AMA RUC process so that these interim final refinements by CMS could be avoided. Response: We appreciate the commenters’ sugg estion. We also encourage the AMA RUC and other public commenters to consider issues related to maintaining appropriate relativity among related codes or between the PE, work, and malpractice components of the PFS payment for individual codes in the development of the recommendations that they provide to us. We believe that the AMA RUC and medical specialty so cieties, in light of CP T code descriptors and other language, as well as the guiding principles establishe d through PFS rulemaking, are in a good position to identify, review, an d develop direct PE input reco mmendations for coherent sets of codes, including component and combined c odes, that ought to be developed or updated concurrently. In the CY 2012 PFS final rule with comment period (76 FR 73213), we addressed the general nature of some of our common refine ments to the AMA RUC-recommended direct PE inputs as well as the reasons for refinements to particular inputs. In the following subsections, we respond broadly to comments we received regarding common refinements we made based on established principles or policies. Following those discussions, we summarize and respond to comments received regarding other refi nements to particular codes. We note that the interim final direct PE i nputs for CY 2012 that are being finalized for CY 2013 are displayed in the final CY 2013 dire ct PE input database, available on the CMS website under the downloads for the CY 2013 PFS final rule at www.cms.gov/PhysicianFeeSched/ . The inputs displayed there have also been used in developing the CY 2013 PE RVUs as displayed in Addendum B of this final rule. We also note that for several codes for whic h we established interim final direct PE inputs for CY 2012, we either made proposals in the CY 2013 PFS proposed rule with comment444 period as a result of those comments or we ar e establishing CY 2013 interim final direct PE inputs for the services based on new recomme ndations from the AMA RUC. We acknowledge receipt of those comments here and we note that those comments were taken into consideration in the development of CY 2013 PFS proposals a nd our consideration of the CY 2013 AMA RUC direct PE input recommendations.
ii Common Refinements (1) Equipment Time Prior to CY 2010, the AMA RUC did not gene rally provide CMS with recommendations regarding equipment time inputs. In CY 2010, in the interest of ensuring the greatest possible degree of accuracy in allocati ng equipment minutes, we request ed that the AMA RUC provide equipment times along with the other direct PE recommendations, and we provided the AMA RUC with general guidelines rega rding appropriate equipment time inputs. We continue to appreciate the AMA RUC’s willingness to provide us with these additional inputs as part of its direct PE recommendations. In general, the equipment time inputs corre spond to the intra-se rvice portion of the clinical labor times. We have clarified that assu mption to consider equipment time as the sum of the times within the intra-service period when a cl inician is using the pie ce of equipment, plus any additional time the piece of equipment is not available for use for another patient due to its use during the designated procedure. In addition, when a piece of equipment is typically used during additional visits include d in a service’s global period, the equipment time should also reflect that use. We believe that certain highly technical pi eces of equipment and equipment rooms are less likely to be used during all of the pre-se rvice or post-service task s performed by clinical labor on the day of the procedure (t he clinical labor service period) and are typically available for445 other patients even when one member of clinical staff may be occupied with a pre-service or post-service task related to the procedure. Some commenters have repeatedly objected to CMS’ rationale for refinement of equipment minutes on this basis. We acknowle dge the comments we received that reiterate those objections to this rationale and refer read ers to our extensive discussion regarding those objections in the CY 2012 PFS final rule with commenter period (76 FR 73182). In following paragraphs we address new comments on this policy.
Comment: One commenter suggested that “CMS allows only a single staff type” for certain services, so that when pre-service and post-service clin ical labor tasks are assigned only to one type of clinical labor (a CT technologi st, for example), the equipment otherwise used by that technologist (the CT room) is necessarily unavailable to another patient. Therefore, the commenter argued that in those cases CMS should al so allocate the total number of minutes for all the clinical labor tasks on the day of the servic e to the CT room regardless of whether or not it is typical for the pre-service or post-service activities to actual ly take place in the room. Response: We understand the commenter’s argu ment, but we do not agree with the conclusion for several reasons. First, we do not agree that allocating a number of minutes to a particular type of clinical sta ff in the direct PE input database can be appropriately viewed as CMS “allowing only a single staff type” being used to furnish services to Medicare beneficiaries. We believe that the direct PE i nput database should reflect the resources typically required in furnishing particular services, but we have no re ason to believe that the inputs included in the database are prescriptive as to what actually ha ppens in a medical practice. Therefore, we do not think the direct PE database staff type is likely to be a determining factor for the division of labor in physician offices and other nonf acility settings. Furthermore, we do not believe that most free-standing centers that furnish highly technica l services to Medicare beneficiaries typically446 only employ one clinical staff member at a time. Therefore, it would not be reasonable to assume that all capital equipment in a typical practice is unavailable for use whenever pre- or post-service tasks are be ing undertaken by any indi vidual technologist. We also note that there are hundr eds of services in the dire ct PE input database that include more than one type of staff in the clini cal labor inputs. For many services, for example, minutes are allocated for a standard nurse blend st aff type for pre-service and post-service tasks, while technologists are only allo cated intra-service period minutes. There is no standing CMS policy that would prevent consider ation of dividing clinical labor tasks among different types of clinical labor in the direct PE input database.
Comment : One commenter expressed a concern regarding the relatio nship between the CMS refinement of recommended equipment minut es and the 75% equipment utilization rate assumption mandated by section 1848( b)(4)(C) of the Act. The comme nter also stated that these refinements are arbitrary and will further widen the gap between Medicare payments determined by the Medicare hospital outpatient prospectiv e payment system (OPPS) and the technical component of PFS services. Response : As we have previously stated, we believe that many of the pre-service and post-service clinical labor tasks typically take place outside of resource-intensive equipment rooms to maximize use of capital- intensive resources. Monopolizing the room for fewer minutes per patient maximizes the availabili ty of the machines. In turn, the assumed rate of use for the machine should be greater, and the resource co st of the machine is reduced through these efficiencies. Since the direct PE input databa se should reflect the t ypical resource costs of medical equipment, we believe that the reduced minutes and increased utilization rate are complementary, not contradictory.447 In response to the commenter’s second assertion, these refinements are far from arbitrary. We have consistently applied these principles in refining the direct PE inputs for services as we review equipment inputs through th e potentially misvalued code in itiative and our review of new and revised codes since the AM A RUC started providing equipmen t minute recommendations to CMS in 2010. We believe that im precise allocation of equipment minutes may be a significant factor in certain potentially misvalued codes. We understand the importance of relativity within the equipment category of direct practice expens es and seek public comment on whether it might be necessary to consider making corresponding re finements to equipment minutes for services across the fee schedule for the sake of maintaining relativity. Finally, as a general statement, differences in payment rates between different payment systems do not necessarily indicate a lack of ap propriate relativity within each system. There can be legitimate reasons why a payment rate sh ould vary in different payment systems (for example, higher indirect costs, different paymen t bundles). Nevertheless , excessive differences in payment rates between payment systems can be one indication of the need to examine the relativity between services in one or both systems. While we continue to examine this issue, we do not believe that it would be appropriate to establish or maintain inaccurate direct PE inputs for these services based on comparisons betw een the PFS and OPPS payment rates. We will continue to work to improve the accu racy of the equipment minutes as reflected in the direct PE input database and will address any further improvements in future rulemaking. After consideration of these comments, we ar e finalizing the current interim final direct PE inputs as refined based on this policy. The direct PE inputs are displayed in the final CY 2013 direct PE input database, available on th e CMS website under the downloads for the CY 2013 PFS final rule at www.cms.gov/PhysicianFeeSched/. (2) Changes in Physician Time448 Some direct PE inputs are dire ctly affected by revisions in physician time. Specifically, changes in the intra-service porti ons of the physician time and cha nges in the number or level of postoperative visits associ ated with the global periods result in corresponding changes to direct PE inputs. While the direct PE input recomm endations generally correspond to the physician time values associated with services, we believe that in some cases in advertent discrepancies between physician time values and direct PE i nputs should be refined in the establishment of interim final direct PE inputs. In other cases , CMS refinement of recommended interim final physician times prompts necessary adjustments in th e direct PE inputs. In the context of our establishment of interim final direct PE input s for CY 2013, we explain those refinements in section III.M.3.b of this final rule with comment period.
Comment : One commenter requested an explan ation regarding why CMS assumes that the clinical time allocated fo r assisting the physician performi ng the procedure should conform to the physician intra-service time. Response : As we have explained in pr evious rulemaking (76 FR 73213), for most codes valued in the nonfacili ty setting, a portion of the clinical labor time allocated to the intra-service period reflects mi nutes assigned for assisting the physician with the procedure. This time is usually allocated at some propor tion of the physician time for a procedure. Frequently, the allocation is for the full physician intraservice time; this reflects the assumption that the clinical staff is assi sting the physician during the entire procedure. For other services, the allocation is tw o-thirds or one-half of the physician tim e; this reflects the assumption that clinical staff is assisting the phys ician for a portion of the procedur e time. In establishing interim final direct PE inputs, we note a change in cl inical labor time (or corresponding change in equipment minutes) that results from a change in physician time as “conforming to physician time.” This note is not used to reflect a refi nement to the recommende d proportion for which the449 staff is assisting the physician performing the pr ocedure. Instead, these refinements reflect a change in the base procedure time assumption fo r the service. After consideration of this comment, we are finalizing the current interim fi nal direct PE inputs as refined based on this policy. The direct PE inputs are displayed in the final CY 2013 direct PE input database, available on the CMS website under the downl oads for the CY 2013 PFS final rule at www.cms.gov/PhysicianFeeSched/. (3) Proxy Inputs for Digital Imaging
Comment : In the context of seve ral codes, several commenters objected to CMS’ not accepting certain recommended items as direct PE inputs since these items, though atypical, may be considered surrogate items for digital imaging technology. Response : A variety of imaging services across the PFS include direct PE inputs that reflect film-based technology instead of digita l technology. We have ac cepted the film-based technology inputs in the RUC reco mmendations as proxy inputs until a more comprehensive migration of such inputs from film to digital imaging can be executed. We anticipate updating all of the associated inputs in future rulemaking. After consideration of these comments, we ar e finalizing the current interim final direct PE inputs as refined based on this policy. The direct PE inputs are displayed in the final CY 2013 direct PE input database, available on th e CMS website under the downloads for the CY 2013 PFS final rule at www.cms.gov/PhysicianFeeSched/. iii Code-specific direct PE inputs (1) Integumentary System: Repair (Closure) (CPT Codes 15271, 15273, 15275, 15277) In establishing interim final direct PE inputs for 2012, CMS refined the AMA RUC’s recommendation for CPT codes 15271 (Application of skin substitute graft to trunk, arms, legs, total wound surface area up to 100 sq cm; first 25 sq cm or less wound surface area), 15273450 (Application of skin substitute graft to trunk, arms , legs, total wound surface area greater than or equal to 100 sq cm; first 100 sq cm wound su rface area, or 1% of body area of infants and children), 15275 (Application of skin substitute gr aft to face, scalp, eyelids, mouth, neck, ears, orbits, genitalia, hands, feet, and/or multiple digits, total wound surface area up to 100 sq cm; first 25 sq cm or less wound surface area), and 1 5277 (Application of skin substitute graft to face, scalp, eyelids, mouth, neck, ears, orbits, gen italia, hands, feet, and/or multiple digits, total wound surface area greater than or equal to 100 sq cm; first 100 sq cm wound surface area, or 1% of body area of infants and children) to allocat e the full service period minutes to the basic instrument pack (EQ137) by reducing the equipm ent allocation by 3 minutes to account for the overlapping time for cleaning the room and the pack.
Comment : One commenter disagreed with CMS’ reduction of the recommended minutes and stated that since the pack is unavailable for other patients while the room is being cleaned, the pack should be allocated the full number of service period clinical labor minutes, including the time for cleaning both the room and the pack. The commenter also stated that cleaning of the instruments is discrete work, most ofte n done after the patient's departure. Response : Since clinical labor is allocated a specific number of minutes for cleaning surgical instrument packs, we do not believe th at we should also allo cate the clinical labor minutes for cleaning the other equipment associated with the services. Because we agree with the commenter that the task is discrete from th e cleaning associated with the other equipment and the room itself, we do not think that the instrume nt pack is unavailable when the room is being cleaned. CMS also refined the r ecommended direct PE input s for CPT codes 15273 and 15275 by not including the post-op incision care (suture) pack (SA054) in each code because the code itself does not describe post-op care.451

Comment : One commenter disagreed with the refinement and pointed out that CPT guidelines state: "Skin replacement surgery cons ists of surgical preparation and topical placement of an autograft (including tissue cultur ed autograft) or skin substitute graft (ie, homograft, allograft, xenograft). The graft is anchored using the provider’s choice of fixation. When services are performed in the office, rou tine dressing supplies are no t reported separately. Removal of current graft and/or simple cleansi ng of the wound is included, when performed." The commenter also noted that CPT codes 15273 and 15277 typically involve large grafts that will be anchored by sutures, and although these c odes have a 0-day global period, removal of the graft is included in the work a nd therefore a suture removal kit is appropriate as a supply item. Response : Based on the rationale presented by the commenters, CMS agrees that one pack should be included as a s upply item for CPT codes 15273 and 15277. After consideration of the commen ts received, we are finalizing the direct PE inputs for CPT codes 15271, 15273, 15275, and 15277 as established as interim final with the additional refinement of incorporating the supply ite m discussed above for CPT codes 15273 and 15277. (2) Musculoskeletal: General: Intr oduction or Removal (CPT Code 20527) In establishing interim final direct PE inputs for 2012, CMS refined the AMA RUC’s recommendation for CPT code 20527 (Injection, enzy me (eg, collagenase), palmar fascial cord (ie, dupuytren's contracture)) by including a mi nimum multi-specialty vis it pack (SA048) as a direct PE input for the service.
Comment : A commenter presented information indicating that the multi-specialty pack is not typically used in furnishing the service. Response : We agree with the information presented by the commenter. After consideration of this co mment, we are finalizing the di rect PE inputs for CPT code 20527 as established as interim final with the addi tional refinement of removing the supply item452 discussed above. The direct PE inputs are di splayed in the final CY 2013 direct PE input database, available on the CMS website under th e downloads for the CY 2013 PFS final rule at www.cms.gov/PhysicianFeeSched/. (3) Musculoskeletal: Spine (Vet ebral Column) (CPT Code 22525) In establishing interim final direct PE inputs for 2012, CMS refined the AMA RUC’s recommendation for CPT code 22525 (Percutaneous vertebral augmenta tion, including cavity creation (fracture reducti on and bone biopsy included when performed) using mechanical device, 1 vertebral body, unilateral or b ilateral cannulation (eg, kyphoplasty); each addi tional thoracic or lumbar vertebral body (list separately in addi tion to code for primary procedure))by not including additional clinical labor and equipmen t time for preparing the room, equipment, and supplies since the CPT code 22525 is an add-on code and time for those tasks is already included in the base code.
Comment : A commenter disagreed with the remova l of 2 minutes for preparing the room, equipment, and supplies and stated that since th e add-on code requires more equipment than the base code the direct PE inputs should include ad ditional minutes for preparing that equipment. Response : Based on our clinical review, we believ e that the standard number of minutes allocated for the clinical labor to prepare the room, equipment, and supplies in the base code approximates the typical number of minutes for such tasks including the cases where the add-on code is necessary. Were the minutes accounted fo r separately in the add-on code, the number of minutes included in the base code would need to be re-examined. At this time, we believe that it would be more appropriate to maintain the standa rd number of minutes in the base code and not allocate additional time in the add-on code.
Comment : A commenter informed CMS that the clinical labor codes associated with CPT Code 22525 were transposed in the direct PE input database.453
Response: We appreciate being informed of the inadvertent assignment of labor codes. After consideration of these comments, we are finalizing the direct PE inputs for CPT code 22525 as established as interim final with the additional refinement of assigning the appropriate labor codes. (4) Musculoskeletal: Hand and Fingers (CPT Code 26341) In establishing interim final direct PE inputs for 2012, CMS refined the AMA RUC’s recommendation for CPT code 26341 (Manipulation, pa lmar fascial cord (ie, dupuytren's cord), post enzyme injection (eg, collagenase), single cord) by including a minimum multi-specialty visit pack (SA048) as a direct PE input for th e service period in the nonfacility and the same pack in both settings to account for the post- service office visit incl uded in the global period.
Comment : A commenter stated that while the p ack was typically used in the nonfacility setting during the service period, it is not typically used for the post-service office visit. Response : The allocation of the supply pack minutes in the facility setting reflects the standard allocation of direct PE inputs based on the office visits included in the global period for the service. We discuss the speci fics related to these standard a llocations in section III.M.3.b of this final rule with comment period. At this ti me, we do not believe it would be appropriate to deviate from these standards. We direct read ers interested in the a ppropriate va luation of services with global periods to section III.B.2.d of this final rule with comment period. After consideration of this comment, we are finalizing the direct PE inputs for CPT code 26341 as established as interim final. The dire ct PE inputs are displayed in the final CY 2013 direct PE input database, available on the CMS website under the downloads for the CY 2013 PFS final rule at www.cms.gov/PhysicianFeeSched/. (5) Respiratory: Lungs and Pleura (CPT Code 32405) and Digestive: Liver (CPT Code 47000)454 In establishing interim final direct PE inputs for 2012, CMS refined the AMA RUC’s recommendations for CPT codes 32405 (Biopsy, l ung or mediastinum, percutaneous needle) and 47000 (Biopsy of liver, needle; percutaneous) by removing minutes allocated to the CT room (EL007) since these services are typically billed with radiological superv ision and interpretation (S&I) services.
Comment : A commenter pointed out that the CT room time included with the S&I code 77012 is only 9 minutes, which reflects a convention for some S&I codes. On this basis, the commenter suggested that for these codes, the CT room should be allocated the standard number of minutes minus the 9 minutes that overlap with the S&I code. Response : We appreciate the commenter pointing out this allocation of equipment minutes. We note that this conve ntion does not apply consistently to all S&I codes and related procedure codes. We may address such inconsistencies in future rulemaking. After consideration of this comment, we are finalizing the direct PE inputs for CPT codes 32405 and 47000 as established as interim final with the additional refinement of including the CT room as a direct PE input fo r the services, with the reducti on of 9 minutes to account for the overlapping number of minutes a llocated in the S&I code. (6) Cardiovascular: Arteries and Veins (CPT Codes 36200, 36246, 36247) In establishing interim final direct PE inputs for 2012, CMS refined the AMA RUC’s recommendations for CPT codes 36200 (Introduc tion of catheter, aorta), 36246 (Selective catheter placement, arterial sy stem; initial second order abdomin al, pelvic, or lower extremity artery branch, within a vascular family), and 36247 (Selective catheter placement, arterial system; initial third order or more selective abdo minal, pelvic, or lower extremity artery branch, within a vascular family) by reducing the numbe r of clinical labor minutes allocated for455 preparing the room, equipment, and supplies used in the servi ce to the standard number of minutes allocated to clinical labor for those tasks.
Comment: One commenter stated that since vascular procedures have more variable supplies than typical procedures, more minutes fo r preparing supplies shoul d be allocated for the clinical labor dire ct PE inputs. Response : Upon clinical review of these procedures, we believ e that the standard number of minutes allocated for such ta sks in similar services across the direct PE input database adequately accounts for the variability of supplies in these procedures. After consideration of this comment, we are finalizing the direct PE inputs for CPT codes 36200, 36246, and 36247 as established as interim final. The direct PE inputs are displayed in the final CY 2013 direct PE input database, av ailable on the CMS website under the downloads for the CY 2013 PFS final rule at www.cms.gov/PhysicianFeeSched/. (7) Digestive: Abdomen, Peritone um, and Omentum (CPT Code 49083) In establishing interim final direct PE inputs for 2012, CMS refined the AMA RUC’s recommendations for CPT code 49083 (Abdominal paracentesis (diagnostic or therapeutic); with imaging guidance) by reducing the number of clini cal labor minutes recomm ended for a series of tasks to correspond with the standard minutes as allocated across PFS services. Additionally, CMS refined the minutes allocated to the equipm ent associated with the service based on the standard allocation of minutes for highly technical and resource -intensive equipment.
Comment: A commenter suggested that 42 minutes should be allocated to the equipment using CMS’ methodologies and in cluding the 25 minutes corres ponding to the assist physician time. Response : We agree with the commenter that the 25 minutes is the appropriate time allocated for assisting the physicia n. However, we do not agree w ith the final number of minutes456 that should be allocated for the equipment. Ba sed on our standard review for such equipment, we believe that the equipment should be allocated the minutes assumed for preparing the room, equipment, and supplies, preparing and positioning the patient, the procedure time itself, and the time allocated to clean the room and the equipm ent. Based on the procedure-specific assist physician time and the standard number of minutes allocated for the additional pre-service and post-service tasks, we have calculated the appropriate equipment minutes to sum to 32. After consideration of this comment, we are finalizing the direct PE inputs for CPT code 49083 as established as interim final, with the ad ditional refinement of allocating 32 minutes for the equipment used in the service. The direct PE inputs are disp layed in the final CY 2013 direct PE input database, available on the CMS we bsite under the downloads for the CY 2013 PFS final rule at www.cms.gov/PhysicianFeeSched/. (8) Urinary: Bladder (CPT Code 51736) In establishing interim final direct PE inputs for 2012, CMS refined the AMA RUC’s recommendations for CPT code 51736 (Simple uroflowmetry (ufr) (eg, stop-watch flow rate, mechanical uroflowmeter)) by adding the followi ng supplies to the direct PE inputs for the service based on CMS clinical review: paper to wel (SK082), disinfecta nt spray (SM012), and sanitizing cloth wipe (SM022).
Comment: A commenter disagreed with this refi nement and suggested instead that these supplies, as well as the digital uroflowmeter (EQ259), should instea d only be included as direct PE inputs for CPT code 51741 (Complex uroflowm etry (eg, calibrated electronic equipment)). Response : Upon further clinical review, and on the basis of the commenter’s recommendation, we agree that the items should be removed from the service. After consideration of this comment, we are finalizing the direct PE inputs for CPT code 51741 as established as interim final, with the ad ditional refinement of removing the three supply457 items and one equipment item identified above. Th e direct PE inputs are displayed in the final CY 2013 direct PE input database, available on the CMS website under the downloads for the CY 2013 PFS final rule at www. cms.gov/PhysicianFeeSched/. (9) Nervous: Extracranial Nerves, Peripheral Nerves, and Autonomic Nervous System (CPT Codes 64633, 64635) In establishing interim final direct PE inputs for 2012, CMS refined the AMA RUC’s recommendations for CPT code 64633 (Destruction by neurolytic agent, para vertebral facet joint nerve(s), with imaging guidance (f luoroscopy or ct); cer vical or thoracic, si ngle facet joint) and 64635 (Destruction by neurolytic agent, paravertebra l facet joint nerve(s), with imaging guidance (fluoroscopy or ct); lumbar or sacral, single facet joint) by not including the recommended radiofrequency probe kit (SA100) as a supply item. As we e xplained in the CY 2012 PFS final rule (76 FR 73214), the very expensive disposable item had not previously been included as a direct PE input for predecessor codes that described the same services, and the recommendation did not include any information suggesting that such a signifi cant resource cost had become typical in furnishing the se rvices. At that time, we noted that the direct PE inputs for these codes were considered interim for CY 2012, and we would consider any submitted information regarding the use of this supply in furnishing th ese services prior to finalizing the direct PE inputs for CY 2013.
Comment: One commenter responded to this re finement by explaining that furnishing the service requires a radiofrequency kit, but that the kit is reusable and typically has a useful life of several months. Response : We appreciate the information from the commenter, though we generally prefer additional information, in cluding paid invoices, in orde r to price supply or equipment items accurately. For CY 2013, we believe it woul d be appropriate to finalize the direct PE458 inputs for these services with a new equipment item based on the disposable item included in the original recommendation and the information supplied by the commenter. We encourage stakeholders to submit additional information through the public process for updating prices for supplies and equipment we established in th e CY 2011 PFS final rule (75 FR 73205-73207). We believe that that process will allow us to descri be the item and assign it s price and useful life more accurately. CMS also refined the reco mmended direct PE inputs for CPT codes 64633 and 64635 by allocating equipment minutes in the facility setting for the exam table (EF023) and the exam light (EQ168) based on the post- service office visits include d in the global periods.
Comment : One commenter suggested that alloca ting this time was not appropriate. Response : The allocation of e quipment minutes in the facility setting reflects the standard allocation of direct PE inputs based on the offi ce visits included in the global period for the service. We discuss the specifics related to thes e standard allocations in section III.M.3.b of this final rule with comment period. At this time, we do not believe it would be appropriate to deviate from these standards. We direct read ers interested in the a ppropriate va luation of services with global periods to section III.B.2.d of this final rule with comment period. After consideration of these comments, we are finalizing the direct PE inputs for CPT code 64633 and 64635 as established as interim fi nal, with the additi onal refinement of establishing this equipment item, “radiofreque ncy kit for destruction by neurolytic agent” (EQ354) as a placeholder direct PE input for the codes until we receive more information regarding the item. The direct PE inputs are displayed in the final CY 2013 direct PE input database, available on the CMS website under th e downloads for the CY 2013 PFS final rule at www.cms.gov/PhysicianFeeSched/. (10) Diagnostic Radiology: Spin e and Pelvis (CPT Code 72120, 72170)459 In establishing interim final direct PE inputs fo r 2012, CMS refined the direct PE inputs for CPT codes 72120 (Radiologic examination, spine, lum bosacral; bending views only, 2 or 3 views) and 72170 (Radiologic examination, pelvis; 1 or 2 views) by reducing the number of minutes allocated to the clinical labor for clean ing the room and equipment to one.
Comment : A commenter disagreed with the revi sion and suggested that CMS should use the standard 3 minutes for this activity. Response : We appreciate the commenter’s interest in CMS using the standard number of minutes for clinical labor tasks. As we e xplained in our refinements regarding reducing recommendations that exceeded the standard number of minutes, we believe that the standard number of minutes generally accommodates the range of minutes likely to be typical for such activities. We agree that it would be appropr iate to include the standard minutes for these services. After consideration of these comments, we are finalizing the direct PE inputs for CPT codes 72120 and 72170, with the additional refineme nt of allocating two additional minutes to the clinical labor and the associ ated equipment inputs for cleaning the room and equipment. The direct PE inputs are displayed in the final CY 2013 direct PE input database, available on the CMS website under the downloads fo r the CY 2013 PFS final rule at www.cms.gov/PhysicianFeeSched/. (11) Nuclear Medicine: Diagnos tic (CPT Codes 78226, 78227, 78579, 78580, 78582, 78597, 78598) In establishing interim final direct PE inputs for 2012, CMS refined the AMA RUC’s recommendations for CPT codes 78226 (Hepatobili ary system imaging, including gallbladder when present;), 78227(Hep atobiliary system imaging, including gallbladder when present; with pharmacologic intervention, including quantitat ive measurement(s) when performed), 78579460 (Pulmonary ventilation imaging (eg, aerosol or gas)), 78580 (Pulmonary perfusion imaging (eg, particulate)), 78582 (Pulmonary ventilation (eg, aerosol or gas) and perfusion imaging), 78597 (Quantitative differential pulmonary perfusi on, including imaging when performed), and 78598 (Quantitative differential pulmonary perfusion and ventilation (eg, aerosol or gas), including imaging when performed) by refining equipmen t time allocations as described in section III.M.2.b above.
Comment : One commenter disagreed with those refinements and urged CMS to identify the clinical labor task s associated with the minutes excluded from the equipment allocation. Response : We refer the commenter to the di scussion above regarding the general principles of accurate assignment of equipment minut es. In the case of this family of codes, we believe that it is appropriate to allocate equipmen t minutes for clinical la bor tasks of preparing the room, positioning the patient, placing the IV, acquiring images during the procedure itself, and cleaning the room, including additional minutes of cleaning for regulatory compliance. We do not believe that expensive equipment is typica lly unavailable for use for other patients while clinical staff performs such tasks as greet ing and gowning the patient , reviewing mandatory radiation education, helping the patient to the waiting room, completing diagnostic forms or making lab and X-ray requisitions. The minutes allo cated to the equipment in the direct PE input database reflect the application of these prin ciples as specifically determined through CMS clinical review. CMS also refined the recommended di rect PE inputs for CPT codes 78226, 78227, 78579, 78580, 78582, 78597, 78598 by examining all of the educational tasks included in the AMA RUC’s recommendation and re fining the sum of those times to a total number of minutes considered accurate under CM S clinical review. The AM A RUC recommendation included 6461 minutes of education by the nuclear medicine te chnologist. CMS refined the total number of minutes allocated for educational tasks to 4.
Comment : One commenter disagreed with the refinement to remove the minutes allocated for providing patient counseling while th e patient is being taken back to the waiting area. This commenter suggested that CMS may be confusing th e recommended minutes for this task with the concurrent recommendation to incl ude the standard number of minutes for patient education. The commenter suggested that since nuclear medicine patients are radioactive when they leave departments, they requ ire more education than other serv ices, especially since patients need to be reminded about the dangers of ra dioactivity after they leave the office. Response : We agree with the commenter that it is reasonable for more time to be allocated to these services for patient education. We also not e that our interim refinements included more education time than typical for PFS services. However, we believe that it would be appropriate to include a tota l of 5 minutes for clinical labor patient education activities for these services in considerati on of the comments received. CMS also refined the recommended di rect PE inputs for CPT codes 78226, 78227, 78579, 78580, 78582, 78597, 78598 by examining all of the cl eaning tasks included in the AMA RUC’s recommendation and refining the sum of those times to a total number of minutes considered accurate under CM S clinical review. The AM A RUC recommendation included 13 minutes of cleaning tasks by a nucle ar medicine technologist. CM S refined the total number of minutes allocated for educational tasks to 10.
Comment : One commenter suggested that the fu ll 13 minutes of cleaning per service should be allocated on a standard basis for thes e codes to account for the number of minutes required to meet cleaning regul atory cleaning standards for se rvices that use radioactive462 pharmaceuticals. The commenter also noted that this allocation has been included in similar services. Response : Upon clinical review, we continue to doubt that nuclear medicine technologists typically clean th e room and equipment for 13 minutes following every service. However, we acknowledge that there is an add itional cleaning burden for these services, and we also agree with the commenter that other servic es that use similar substances incorporate the same number of minutes for manda ted cleaning. Therefore, we be lieve it is appropriate that these services include these a dditional minutes for cleaning. After consideration of these comments, we are finalizing the direct PE inputs for CPT codes 78226, 78227, 78579, 78580, 78582, 78597, 78598 with the additional refinement of allocating 1 additional clinical labor minute for patient educati on tasks and an additional 3 minutes to the clinical labor and equipment items to account for mandatory cleaning tasks. The direct PE inputs are displayed in the final CY 2013 direct PE input database, available on the CMS website under the downloads fo r the CY 2013 PFS final rule at www.cms.gov/PhysicianFeeSched/. (12) Pulmonary: Diagnostic Tes ting and Therapies (CPT Codes 94728) In establishing interim final direct PE inputs for 2012, CMS refined the AMA RUC’s recommendations for CPT code 94728 (Airway resi stance by impulse oscillometry) by adding the body plethysmograph autobox (EQ044) as direct equipment input for the service based on the item’s inclusion as a direct PE input for related services.
Comment : One commenter noted that this code is used to describe services furnished primarily for children and that the equipment item cannot be used with pediatric patients. Response : We appreciate the additional informati on regarding the appropriate use of the equipment.463
After consideration of these comments, we are finalizing the direct PE inputs for CPT code 94728 with the additional refinement of rem oving the equipment item discussed above as a direct PE input for the service. The direct PE inputs are displayed in th e final CY 2013 direct PE input database, available on the CMS website under the downloads for the CY 2013 PFS final rule at www.cms.gov/PhysicianFeeSched/. (13) Hydration, Therapeutic, Prophylactic, Diagnostic Injections and Infusions, and Chemotherapy and Other Highly Complex Drug or Highly Complex Biologic Agent Administration (CPT Codes 96413, 96416) In establishing interim final direct PE inputs for 2012, CMS refined the AMA RUC’s recommendations for CPT code 96413 (Chemoth erapy administration, intravenous infusion technique; up to 1 hour, single or initial subs tance/drug) by not including the 6 clinical labor minutes in the pre-service period for completi ng pre-service diagnostic and referral forms and coordinating pre-surgery services since these ta sks are not generally allocated for services without global periods.
Comment : Several commenters suggested that the recommended times for these tasks reflects the time for the oncology nurse to doc ument the upcoming chemotherapy session based on the physician's orders, coordinate the service u nder the physician's dire ction, ensure that the planned infusion is consistent with physician's di rection, and confirm that there is no change in the drugs to be infused, anti-emetics to be supplied, or post-treatment instructions. The commenter also noted that the minutes al located for those tasks in CPT code 96416 (Chemotherapy administration, intravenous in fusion technique; in itiation of prolonged chemotherapy infusion (more than 8 hours), requi ring use of a portable or implantable pump) were removed in the same reco mmendation in order to account fo r the overlap in tasks since CPT code 96413 is typically also reporte d whenever CPT code 96416 is reported.464
Response : We agree with the commenter’s reco mmendation to include those six minutes in CPT code 96413 and exclude those minutes in CPT code 96416, consistent with the AMA RUC recommendation. CMS refined the recommended direct PE i nputs for CPT code 96416 by not including the 4 minutes assigned to the c linical labor for reviewing the charts and obtain chemotherapyrelated medical history. This refi nement reflected that CMS clinical review concluded that these tasks are already accounted for in the clinical labor minutes assigned to CPT code 96413 and would typically not be re peated when CPT code 96416 is reported.
Comment : Several commenters claimed that the nur se must perform these tasks and that the time is appropriately valued at 4 minutes. Response : We agree with the commenters that the time for the tasks is appropriately estimated at 4 minutes, but we maintain our belief that the tasks fully overlap with the same tasks associated with CPT code 96413, which is typica lly also reported whenever CPT code 96416 is reported. Therefore, we do not believe those 4 mi nutes should be allocated to both services. CMS also refined the recomm ended direct PE inputs fo r CPT code 96416 by examining all of the tasks described in the AMA RUC’ s recommendation for monitoring the patient and removing the minutes that overlap with monitoring included in CPT code 96413. This refinement assumed no monitoring was necessary beyond the monitoring time already associated with CPT code 96413.
Comment : One commenter objected to the refinement of the intra-service time since the clinical labor performs the procedure. Response : We agree with the commenter that the recommendation reflects that the clinical staff is performing the procedure. The ra tionale for our refinement of the minutes for the task “assist physician performing the procedur e” was described broadly as “conforming to465 physician time” in the CY 2012 PFS final rule (76 FR 73264), but was sp ecifically intended to address the overlap in minutes allocated for m onitoring the patient following the administration. We continue to believe that some of the 18 recommended minutes for monitoring tasks in CPT code 96416 overlap with the 24 minutes included in CPT code 96413 for monitoring. However, upon further clinical review, we be lieve that the overlap is not complete and that it would be appropriate to increase the total clinical labor minutes allocated in the service period by an additional 11 minutes to account for the additiona l monitoring that would typically occur when CPT code 96416 is furnished. After consideration of these comments, we are finalizing the direct PE inputs for CPT codes 96413 and 96416 with the additional refineme nts of including an a dditional 6 minutes of clinical labor time in the pre- service period for CPT code 96413 and including an additional 11 minutes of clinical labor time in the service pe riod for CPT code 96416. We also note that the minutes allocated to the equipmen t inputs will increase based on our standard allocation policies. The direct PE inputs are displaye d in the final CY 2013 direct PE input database, available on the CMS website under the downloads fo r the CY 2013 PFS final rule at www.cms.gov/PhysicianFeeSched/. For all other CY 2012 new, revised, or poten tially misvalued codes with CY 2012 interim final RVUs that are not specifically discussed in this final rule with comment period, we are finalizing, without modification, the interim final direct PE inputs that we initially adopted for
CY 2012. c. Finalizing CY 2012 Interim and Propos ed Malpractice Crosswalks for CY 2013 Consistent with our malpractice methodology de scribed in section III.C.1. of this final rule with comment period, for the CY 2012 PFS final rule, we assigned malpractice RVUs for CY 2012 new and revised codes by u tilizing crosswalks to source codes that have a similar466 malpractice risk-of-service. After reviewi ng the AMA RUC-recommended malpractice source code crosswalks for CY 2012 new and revised co des, we accepted nearly all of them on an interim final basis for CY 2012. As detailed in the CY 2012 final rule with comment period (76 FR 73264 through 73265), for four CPT codes desc ribing multi-layer compression systems, we assigned a malpractice crosswalk different from the malpractice crosswalk recommended by the AMA RUC and HCPAC. In the CY 2012 PFS final rule with comme nt period, for CPT codes 29581 (Application of multi-layer compression system; leg (bel ow knee), including ankle and foot), 29582 (Application of multi-layer compression system; thigh and leg, including ankle and foot, when performed), 29583 (Application of multi-layer compression system; upper arm and forearm), and 29584 (Application of multi-layer compression system; upper arm, forearm, hand, and fingers), we assigned an interim final malpractice cr osswalk from CPT code 97140 (Manual therapy techniques (eg, mobilization/ manipulation, manu al lymphatic drainage, manual traction), 1 or more regions, each 15 minutes). CPT codes 29582, 29583, and 29584 were new for CY 2012. The AMA RUC recommended, and we agreed, that the estimated utilization for CPT codes 29582, 29583, and 29584 would have previously been reported using CPT code 97140. After review, we believed that CPT c ode 97140 provides the most appropr iate malpractice source code crosswalk for CPT codes 29582, 29583, and 29584. As di scussed in section II I.M.3 of this CY 2013 final rule with comment period, in the CY 2012 PFS final rule with comment period we stated that we believe CPT codes 29581, 29582, 29583, and 29584 all describe similar services from a resource perspective, and we assigned CPT code 29581 the same interim work RVU as CPT code 29583. Because we find these services to be so similar, we stated that we also believed that it is appropriate for CPT code s 29581 and 29583 to have the same malpractice source code crosswalk. Therefor e, we assigned CPT code 97140 as the malpractice source code467
crosswalk for CPT codes 29581, 29582, 29583, and 29584. Additionally, for CY 2012 we created HCPCS G-code G0451 (Development testing, with interpretation and report, per standardized instrument form) to replace CPT code 96110 (Developmental screening, with interpretation and report, per standardized instrument form). For CY 2012, we assigned CPT code 96110 as th e malpractice source code crosswalk for HCPCS code G0451. In accordance with our malpractice methodology, we adjusted the malpractice RVUs for the CY 2012 new/revised codes for the difference in work RVUs (or, if greater, the clinical labor portion of the fully implemented PE RVUs) betw een the source codes and the new/revised codes to reflect the specific risk-of-service for the ne w/revised codes. The interim final malpractice crosswalks were listed in Table 22 of the CY 2012 PFS final rule with comment period (76 FR 73266 through 73268). We received no comments on the CY 2012 inter im final malpractice crosswalks and are finalizing them without modifica tion for CY 2013. The malpractice RVUs for these services are reflected in Addendum B of this CY 2013 PFS fina l rule with comment period. d. Other New, Revised or Potentially Mi svalued Codes with CY 2012 Interim Final RVUs or CY 2013 Proposed RVUs Not Specifically Di scussed in the CY 2013 Final Rule with
Comment Period For all other new, revised, or potentially misvalued codes with CY 2012 interim final RVUs or CY 2013 proposed RVUs that are not speci fically discussed in this final rule with comment period, we received no public commen ts and, as such, we are finalizing, without modification, the interim final or proposed work and direct PE inputs we initially adopted in the CY 2012 final rule with comment period or th e CY 2013 proposed rule, respectively. The time values for all codes appear on the CMS website at468 www.cms.gov/PhysicianFeeSched/. Refer to Adde nda B for a comprehensive list of all final values.

3. Establishing Interim Final RVUs for CY 2013 a. Establishing CY 2013 Interim Final Work RVUs As previously discussed in section III.M.2 of this final rule with comment period, on an annual basis the AMA RUC and HCPAC, along w ith other public commenters, provide CMS with recommendations regarding physician work va lues for new and revised CPT codes. This section discusses services for which CMS disa greed with the recommended physician work RVU or time values for CY 2013 new or revised CPT code s, services that had interim or interim final values in CY 2012 and will continue to have inte rim or interim final values for CY 2013, as well as the physician work and time values for new and revised HCPCS G-codes. The interim or interim final work RVUs for all codes in this section, including those where CMS agreed with the recommended work RVU, appear in Table 2 at the start of this section. Unless otherwise indicated, we agreed with the time values recommended by the AMA RUC or HCPAC for all codes addressed in this secti on. The time values for all code s appear on the CMS website at: www.cms.gov/PhysicianFeeSched/. We note that in addition to the CPT codes discussed in this section, the CPT Editorial created, and the AMA RUC reviewed, many new CP T codes for molecular pathology tests. These services will be payable on the Medicare Clinical Laboratory Fee Schedule and are discussed in detail in sect ion III.I of this CY 2013 PFS final rule with comment period. i. Code-specific Issues TABLE 30: Work RVUs for CY 2013 New, Revise d, and Potentially Misvalued Codes469

HCPCS

Code Short Descriptor CY 2012 Work RVU AMA RUC/HCPAC Recommended

Work RVU* CY 2013 Interim/Interim

Final Work RVU Agree/Disagree with AMA RUC/HCPAC Recommended

Work RVU* CMS Refinement to AMA/HCPAC Recommended Time* 10120 Remove foreign body 1.25 1.25 1.22 Disagree Yes 11055 Trim skin lesion 0.43 0.43 0.35 Disagree Yes 11056 Trim skin lesions 2 to 4 0.50 0.50 0.50 Agree No 11057 Trim skin lesions over 4 0.79 0.79 0.65 Disagree Yes 11300 Shave skin lesion 0.5 cm/< 0.51 0.60 0.60 Agree No 11301 Shave skin lesion 0.6-1.0 cm 0.85 0.90 0.90 Agree No 11302 Shave skin lesion 1.1-2.0 cm 1.05 1.16 1.05 Disagree No 11303 Shave skin lesion >2.0 cm 1.24 1.25 1.25 Agree No 11305 Shave skin lesion 0.5 cm/< 0.67 0.80 0.80 Agree No 11306 Shave skin lesion 0.6-1.0 cm 0.99 1.18 0.96 Disagree No 11307 Shave skin lesion 1.1-2.0 cm 1.14 1.20 1.20 Agree No 11308 Shave skin lesion >2.0 cm 1.41 1.46 1.46 Agree No 11310 Shave skin lesion 0.5 cm/< 0.73 1.19 0.80 Disagree No 11311 Shave skin lesion 0.6-1.0 cm 1.05 1.43 1.10 Disagree No 11312 Shave skin lesion 1.1-2.0 cm 1.20 1.80 1.30 Disagree No 11313 Shave skin lesion >2.0 cm 1.62 2.00 1.68 Disagree No 11719 Trim nail(s) any number 0.17 0.17 0.17 Agree No G0127 Trim nail(s) 0.17 N/A 0.17 N/A N/A 12035 Intmd wnd repair s/a/t/ext 3.50 3.60 3.50 Disagree No 12036 Intmd wnd repair s/a/t/ext 4.23 4.50 4.23 Disagree Yes 12037 Intmd wnd repair s/tr/ext 5.00 5.25 5.00 Disagree No 12045 Intmd wnd repair n-hf/genit 3.75 3.90 3.75 Disagree Yes 12046 Intmd wnd repair n-hf/genit 4.30 4.60 4.30 Disagree Yes 12047 Intmd wnd repair n-hf/genit 4.95 5.50 4.95 Disagree Yes 12055 Intmd wnd repair face/ mm 4.50 4.65 4.50 Disagree Yes 12056 Intmd wnd repair face/ mm 5.30 5.50 5.30 Disagree Yes 12057 Intmd wnd repair face/ mm 6.00 6.20 6.00 Disagree Yes 13100 Cmplx rpr trunk 1.1-2.5 cm 3.17 3.00 3.00 Agree Yes 13101 Cmplx rpr trunk 2.6-7.5 cm 3.96 3.50 3.50 Agree Yes 13102 Cmplx rpr trunk addl 5cm/< 1.24 1.24 1.24 Agree No 13120 Cmplx rpr s/a/l 1.1-2.5 cm 3.35 3.23 3.23 Agree Yes 13121 Cmplx rpr s/a/l 2.6-7.5 cm 4.42 4.00 4.00 Agree Yes 13122 Cmplx rpr s/a/l addl 5 cm/> 1.44 1.44 1.44 Agree No 13131 Cmplx rpr f/c/c/m/n/ax/g/h/f 3.83 3.73 3.73 Agree Yes 13132 Cmplx rpr f/c/c/m/n/ax/g/h/f 6.58 4.78 4.78 Agree Yes 13133 Cmplx rpr f/c/c/m/n/ax/g/h/f 2.19 2.19 2.19 Agree No 13150 Cmplx rpr e/n/e/l 1.0 cm/< 3.85 N/A 3.58 N/A N/A 13151 Cmplx rpr e/n/e/l 1.1-2.5 cm 4.49 4.34 4.34 Agree Yes 13152 Cmplx rpr e/n/e/l 2.6-7.5 cm 6.37 5.34 4.90 Disagree Yes 13153 Cmplx rpr e/n/e/l addl 5cm/< 2.38 2.38 2.38 Agree No 20985 Cptr-asst dir ms px 2.50 2.50 2.50 Agree No 22586 Prescrl fuse w/ instr l5/s1 New N/A 28.12 N/A N/A 23350 Injection for shoulder x-ray 1.00 1.00 1.00 Agree No 23331 Remove shoulder foreign body 7.63 7.63 7.63 Interim No 23332 Remove shoulder foreign body 12.37 12.37 12.37 Interim No 23472 Reconstruct shoulder joint 22.65 22.13 22.13 Interim No 23473 Revis reconst shoulder joint New 25.00 25.00 Interim No 23474 Revis reconst shoulder joint New 27.21 27.21 Interim No 23600 Treat humerus fracture 3.11 3.00 3.00 Agree No 24160 Remove elbow joint implant 8.00 8.00 8.00 Interim No 24363 Replace elbow joint 22.6 5 22.00 22.00 Interim Yes470

HCPCS

Code Short Descriptor CY 2012 Work RVU AMA RUC/HCPAC Recommended

Work RVU* CY 2013 Interim/Interim

Final Work RVU Agree/Disagree with AMA RUC/HCPAC Recommended

Work RVU* CMS Refinement to AMA/HCPAC Recommended Time* 24370 Revise reconst elbow joint New 23.55 23.55 Interim No 24371 Revise reconst elbow joint New 27.50 27.50 Interim No 28470 Treat metatarsal fracture 2.03 2.03 2.03 Agree No 29075 Application of forearm cast 0.77 0.77 0.77 Agree No 29581 Apply multlay comprs lwr leg 0.25 0.60 0.25 Disagree No 29582 Apply multlay comprs upr leg 0.35 0.35 0.35 Agree No 29583 Apply multlay comprs upr arm 0.25 0.25 0.25 Agree No 29584 Appl multlay comprs arm/hand 0.35 0.35 0.35 Agree No 29824 Shoulder arthroscopy/surgery 8.98 8.98 8.98 Interim No 29826 Shoulder arthroscopy/surgery 3.00 3.00 3.00 Interim No 29827 Arthroscop rotator cuff repr 15.59 15.59 15.59 Interim No 29828 Arthroscopy biceps tenodesis 13.16 13.16 13.16 Interim No 31231 Nasal endoscopy dx 1.10 1.10 1.10 Agree Yes 31647 Bronchial valve init insert New 4.40 4.40 Agree No 31648 Bronchial valve addl insert New 4.20 4.20 Agree No 31649 Bronchial valve remov init New 2.00 1.44 Disagree No 31651 Bronchial valve remov addl New 1.58 1.58 Agree No 31660 Bronch thermoplsty 1 lobe New 4.50 4.25 Disagree No 31661 Bronch thermoplsty 2/> lobes New 5.00 4.50 Disagree No 32440 Remove lung pneumonectomy 27.28 N/A 27.28 Interim N/A 32480 Partial removal of lung 25.82 N/A 25.82 Interim N/A 32482 Bilobectomy 27.44 N/A 27.44 Interim N/A 32491 Lung volume reduction 25.24 N/A 25.24 Interim N/A 32551 Insertion of chest tube 3.29 3.50 3.29 Disagree No 32554 Aspirate pleura w/o imaging New 1.82 1.82 Agree No 32555 Aspirate pleura w/ imaging New 2.27 2.27 Agree Yes 32556 Insert cath pleura w/o image New 2.50 2.50 Agree No 32557 Insert cath pleura w/ image New 3.62 3.12 Disagree Yes 32663 Thoracoscopy w/lobectomy 24.64 24.64 24.64 Interim No 32668 Thoracoscopy w/w resect diag 3.00 4.00 3.00 Interim No 32669 Thoracoscopy remove segment 23.53 23.53 23.53 Interim No 32670 Thoracoscopy bilobectomy 28.52 28.52 28.52 Interim No 32671 Thoracoscopy pneumonectomy 31.92 31.92 31.92 Interim No 32672 Thoracoscopy for lvrs 27.00 27.00 27.00 Interim No 32673 Thoracoscopy w/thymus resect 21.13 21.13 21.13 Interim No 32701 Thorax stereo rad targetw/tx New 4.18 4.18 Agree No 33361 Replace aortic valve perq New 29.50 25.1 3 Disagree Yes 33362 Replace aortic valve open New 32.00 27.5 2 Disagree Yes 33363 Replace aortic valve open New 33.00 28.5 0 Disagree Yes 33364 Replace aortic valve open New 34.87 30.0 0 Disagree Yes 33365 Replace aortic valve open New 37.50 33.12 Disagree No 33367 Replace aortic valve w/by p New 11.88 11 .88 Agree No 33368 Replace aortic valve w/by p New 14.39 14 .39 Agree No 33369 Replace aortic valve w/by p New 19.00 19 .00 Agree No 33405 Replacement of aortic valv e 41.32 41.32 41 .32 Interim No 33430 Replacement of mitral valv e 50.93 50.93 50 .93 Interim No 33533 Cabg arterial single 33.75 34.98 33.75 Interim No 33990 Insert vad artery access New 8.15 8.15 Agree No 33991 Insert vad art&vein access New 11.88 11.88 Agree No 33992 Remove vad different session New 4.00 4.00 Agree No 33993 Reposition vad diff session New 4.17 3.51 Disagree No471

HCPCS

Code Short Descriptor CY 2012 Work RVU AMA RUC/HCPAC Recommended

Work RVU* CY 2013 Interim/Interim

Final Work RVU Agree/Disagree with AMA RUC/HCPAC Recommended

Work RVU* CMS Refinement to AMA/HCPAC Recommended Time* 35475 Repair arterial blockage 9.48 6.60 5.75 Disgaree No 35476 Repair venous blockage 6.03 5.10 4.71 Disagree No 36221 Place cath thoracic aort a New 4.51 4.17 Disagree Yes 36222 Place cath carotid/inom ar t New 6.00 5.53 Disagree Yes 36223 Place cath carotid/inom ar t New 6.50 6.00 Disagree Yes 36224 Place cath carotd art New 7.55 6.50 Disagree Yes 36225 Place cath subclavian ar t New 6.50 6.00 Disagree Yes 36226 Place cath vertebral ar t New 7.55 6.50 Disagree Yes 36227 Place cath xtrnl carotid New 2.32 2.09 Disagree No 36228 Place cath intracranial art New 4.25 4.25 Agree No 37197 Remove intrvas foreign body New 6.72 6.29 Disagree No 37211 Thrombolytic art therapy New 8.00 8.00 Agree No 37212 Thrombolytic venous therapy New 7.06 7.06 Agree No 37213 Thromblytic art/ven therapy New 5.00 5.00 Agree No 37214 Cessj therapy cath removal New 3.04 2.74 Disagree No 38240 Transplt allo hct/donor 2.24 4.00 3.00 Disagree No 38241 Transplt autol hct/donor 2.24 3.00 3.00 Agree No 38242 Transplt allo lymphocytes 1.71 2.11 2.11 Agree No 38243 Transplj hematopoietic boost New 2.13 2.13 Agree No 40490 Biopsy of lip 1.22 1.22 1.22 Agree No 43206 Esoph optical endomicroscopy New Contractor Priced Contractor Priced N/A N/A 43252 Uppr gi opticl endomicrscopy New Contractor Priced Contractor Priced N/A N/A 44705 Prepare fecal microbiot a New 1.42 Invalid N/A N/A G0455 Fecal microbiota prep instill New N/A 0.97 N/A N/A 45330 Diagnostic sigmoidoscopy 0.96 0.96 0.96 Agree No 47562 Laparoscopic cholecystectomy 11.76 11.76 10.47 Disagree Yes 47563 Laparo cholecystectomy/graph 11.47 11.47 11.47 Agree No 47600 Removal of gallbladder 17.48 20.00 17.48 Disagree No 47605 Removal of gallbladder 15.98 21.00 18.48 Disagree No 49505 Prp i/hern init reduc >5 yr 7.96 7.96 7.96 Agree No 50590 Fragmenting of kidney stone 9.77 9.77 9.77 Agree No 52214 Cystoscopy and treatment 3.70 3.50 3.50 Agree No 52224 Cystoscopy and treatment 3.14 4.05 4.05 Agree Yes 52234 Cystoscopy and treatment 4.62 4.62 4.62 Agree No 52235 Cystoscopy and treatment 5.44 5.44 5.44 Agree No 52240 Cystoscopy and treatment 9.71 8.75 7.50 Disagree No 52287 Cystoscopy chemodenervation New 3.20 3.20 Agree No 52351 Cystouretero & or pyeloscope 5.85 5.75 5.75 Agree No 52352 Cystouretero w/stone remove 6.87 6.75 6.75 Agree No 52353 Cystouretero w/lithotripsy 7.96 7.88 7.50 Disagree No 52354 Cystouretero w/biopsy 7.33 8.58 8.00 Disagree No 52355 Cystouretero w/excise tumor 8.81 10.00 9.00 Disagree No 53850 Prostatic microwave thermotx 10.08 10.08 10.08 Agree No 60520 Removal of thymus gland 17.16 N/A 17.16 Interim N/A 60521 Removal of thymus gland 19.18 N/A 19.18 Interim N/A 60522 Removal of thymus gland 23.48 N/A 23.48 Interim N/A 64450 N block other peripheral 1.27 0.75 0.75 Agree No 64612 Destroy nerve face musc le 2.01 1.41 1. 41 Interim No 64613 Destroy nerve neck muscle 2.01 N/A 2.01 Interim N/A472

HCPCS

Code Short Descriptor CY 2012 Work RVU AMA RUC/HCPAC Recommended

Work RVU* CY 2013 Interim/Interim

Final Work RVU Agree/Disagree with AMA RUC/HCPAC Recommended

Work RVU* CMS Refinement to AMA/HCPAC Recommended Time* 64614 Destroy nerve extrem musc 2.20 N/A 2.20 Interim N/A 64615 Chemodenerv musc migraine New 1.85 1.85 Interim No 64640 Injection treatment of nerve 2.81 1.23 1.23 Agree No 65222 Remove foreign body from eye 0.93 0.93 0.84 Disagree Yes 65800 Drainage of eye 1.91 1.53 1.53 Agree No 66982 Cataract surgery complex 15.02 11.08 11.08 Agree No 66984 Cataract surg w/iol 1 stage 10.52 8.52 8.52 Agree No 67028 Injection eye drug 1.44 1.44 1.44 Agree No 67810 Biopsy eyelid & lid margin 1.48 1.18 1.18 Agree Yes 68200 Treat eyelid by injection 0.49 0.49 0.49 Agree Yes 69200 Clear outer ear canal 0.77 0.77 0.77 Agree Yes 69433 Create eardrum opening 1.57 1.57 1.57 Agree No 72040 X-ray exam neck spine 3/<vws 0.22 0.22 0.22 Agree No 72050 X-ray exam neck spine 4/5vws 0.31 0.31 0.31 Agree No 72052 X-ray exam neck spine 6/>vws 0.36 0.36 0.36 Agree No 72191 Ct angiograph pelv w/o&w/dye 1.81 N/A 1.81 Interim N/A 73221 Mri joint upr extrem w/o dye 1.35 1.35 1.35 Agree No 73721 Mri jnt of lwr extre w/o dye 1.35 1.35 1.35 Agree No 74170 Ct abdomen w/o & w/dye 1.40 1.40 1.40 Agree No 74174 Ct angio abd&pelv w/o&w/dye 2.20 2.20 2.20 Interim No 74175 Ct angio abdom w/o & w/dye 1.90 N/A 1.90 Interim N/A 74247 Contrst x-ray uppr gi tract 0.69 0.69 0.69 Agree No 74280 Contrast x-ray exam of colon 0.99 0.99 0.99 Agree No 74400 Contrst x-ray urinary tract 0.49 0.49 0.49 Agree No

75896 X-rays transcath therapy 1.31 (PC), Contractor Priced (TC) Contractor Priced 1.31 (PC), Contractor Priced (TC) Interim N/A

75898 Follow-up angiography 1.65 (PC), Contractor Priced (TC) Contractor Priced 1.65 (PC), Contractor Priced (TC) Interim N/A 76830 Transvaginal us non-ob 0.69 0.69 0.69 Agree Yes 76872 Us transrectal 0.69 0.69 0.69 Agree No 77001 Fluoroguide for vein device 0.38 N/A 0.38 Interim N/A 77002 Needle localization by xray 0.54 N/A 0.54 Interim N/A 77003 Fluoroguide for spine inject 0.60 0.60 0.60 Interim No 77080 Dxa bone density axial 0.20 0.20 0.20 Agree No 77082 Dxa bone density vert fx 0.17 0.17 0.17 Agree No 77301 Radiotherapy dose plan imrt 7.99 7.99 7.99 Agree Yes 78012 Thyroid uptake measurement New 0.19 0.19 Agree No 78013 Thyroid imaging w/blood flow New 0.37 0.37 Agree No 78014 Thyroid imaging w/blood flow New 0.50 0.50 Agree No 78070 Parathyroid planar imaging 0.82 0.80 0.80 Agree No 78071 Parathyrd planar w/wo subtrj New 1.20 1.20 Agree No 78072 Parathyrd planar w/spect&ct New 1.60 1.60 Agree No 78278 Acute gi blood loss imaging 0.99 0.99 0.99 Agree No 78472 Gated heart planar single 0.98 0.98 0.98 Agree No G0452 Molecular pathology in terpr New N/A 0.37 N/A N/A 86153 Cell enumeration phys interp New 0.69 0.69 Agree Yes 88120 Cytp urne 3-5 probes ea spec 1.20 1.20 1.20 Interim No 88121 Cytp urine 3-5 probes cmptr 1.00 1.00 1.00 Interim No 88312 Special stains group 1 0.54 0.54 0.54 Agree No473

HCPCS

Code Short Descriptor CY 2012 Work RVU AMA RUC/HCPAC Recommended

Work RVU* CY 2013 Interim/Interim

Final Work RVU Agree/Disagree with AMA RUC/HCPAC Recommended

Work RVU* CMS Refinement to AMA/HCPAC Recommended Time* 88365 Insitu hybridization (fish) 1.20 N/A 1.20 Interim N/A 88367 Insitu hybridization auto 1.30 N/A 1.30 Interim N/A 88368 Insitu hybridization manual 1.40 N/A 1.40 Interim N/A 88375 Optical endomicroscpy interp New Contractor Priced Contractor Priced N/A N/A G0416 Sat biopsy 10-20 3.09 N/A 3.09 N/A N/A 90785 Psytx complex interactive New Contractor Priced 0.11 Interim N/A 90791 Psych diagnostic evaluation New 3.00 2.80 Interim No 90792 Psych diag eval w/med srvcs New 3.25 2.96 Interim No 90832 Psytx pt&/family 30 minutes New 1.50 1.25 Interim No 90833 Psytx pt&/fam w/e&m 30 min New 1.50 0.98 Interim No 90834 Psytx pt&/family 45 minutes New 2.00 1.89 Interim No 90836 Psytx pt&/fam w/e&m 45 min New 1.90 1.60 Interim No 90837 Psytx pt&/family 60 minutes New 3.00 2.83 Interim No 90838 Psytx pt&/fam w/e&m 60 min New 2.50 2.56 Interim No 90839 Psytx crisis initial 60 min New Contractor Priced Contractor Priced N/A N/A 90840 Psytx crisis ea addl 30 min New Contractor Priced Contractor Priced N/A N/A 90845 Psychoanalysis 1.79 2.10 1.79 Interim Yes 90846 Family psytx w/o patient 1.83 2.40 1.83 Interim Yes 90847 Family psytx w/patient 2.21 2.50 2.21 Interim Yes 90853 Group psychotherapy 0.59 0.59 0.59 Interim Yes 90863 Pharmacologic mgmt w/psytx New Contractor Priced Invalid N/A N/A 91112 Gi wireless capsule measure New 2.10 2.10 Agree No 92083 Visual field examination(s) 0.50 0.50 0.50 Agree No 92100 Serial tonometry exam(s) 0.92 0.61 0.61 Agree No 92235 Eye exam with photos 0.81 0.81 0.81 Agree No 92286 Internal eye photography 0.66 0.40 0.40 Agree No 92920 Prq cardiac angioplast 1 art New 9.00 10.10 Disagree Yes 92921 Prq cardiac angio addl art New 4.00 Bundled N/A N/A 92924 Prq card angio/athrect 1 art New 11.00 11.99 Disagree Yes 92925 Prq card angio/athrect addl New 5.00 Bundled N/A N/A 92928 Prq card stent w/angio 1 vsl New 10.49 11.21 Disagree Yes 92929 Prq card stent w/angio addl New 4.44 Bundled N/A N/A 92933 Prq card stent/ath/angio New 12.32 12.54 Disagree Yes 92934 Prq card stent/ath/angio New 5.50 Bundled N/A N/A 92937 Prq revasc byp graft 1 vsl New 10.49 11.20 Disagree Yes 92938 Prq revasc byp graft addl New 6.00 Bundled N/A N/A 92941 Prq card revasc mi 1 vsl New 12.32 12.56 Disagree No 92943 Prq card revasc chronic 1vsl New 12.32 12.56 Disagree Yes 92944 Prq card revasc chronic addl New 6.00 Bundled N/A N/A 93015 Cardiovascular stress test 0.75 0.75 0.75 Agree No 93016 Cardiovascular stress test 0.45 0.45 0.45 Agree No 93018 Cardiovascular stress test 0.30 0.30 0.30 Agree No 93308 Tte f-up or lmtd 0.53 0.53 0.53 Agree No 93653 Ep & ablate supravent arrhyt New 15.00 15.00 Agree No 93654 Ep & ablate ventric tachy New 20.00 20.00 Agree No 93655 Ablate arrhythmia add on New 9.00 7.50 Disagree No474

HCPCS

Code Short Descriptor CY 2012 Work RVU AMA RUC/HCPAC Recommended

Work RVU* CY 2013 Interim/Interim

Final Work RVU Agree/Disagree with AMA RUC/HCPAC Recommended

Work RVU* CMS Refinement to AMA/HCPAC Recommended Time* 93656 Tx atrial fib pulm vein isol New 20.02 20.02 Agree No 93657 Tx l/r atrial fib addl New 10.00 7.50 Disagree No 93925 Lower extremity study 0.58 0.90 0.80 Disagree Yes 93926 Lower extremity study 0.39 0.70 0.50 Disagree Yes 93970 Extremity study 0.68 0.70 0.70 Agree No 93971 Extremity study 0.45 0.45 0.45 Agree No 95017 Perq & icut allg test venoms New 0.07 0.07 Agree No 95018 Perq&ic allg test drugs/boil New 0.14 0.14 Agree No 95076 Ingest challenge ini 120 min New 1.50 1.50 Agree No 95079 Ingest challenge addl 60 min New 1.38 1.38 Agree No 95782 Polysom <6 yrs 4/> paramtrs New 3.00 2.60 Disagree No 95783 Polysom <6 yrs cpap/bilvl New 3.20 2.83 Disagree No 95860 Muscle test one limb 0.96 0.96 0.96 Agree No 95861 Muscle test 2 limbs 1.54 1.54 1.54 Agree No 95863 Muscle test 3 limbs 1.87 1.87 1.87 Agree No 95864 Muscle test 4 limbs 1.99 1.99 1.99 Agree No 95865 Muscle test larynx 1.57 1.57 1.57 Agree No 95866 Muscle test hemidiaphragm 1.25 1.25 1.25 Agree No 95867 Muscle test cran nerv unilat 0.79 0.79 0.79 Agree No 95868 Muscle test cran nerve bilat 1.18 1.18 1.18 Agree No 95869 Muscle test thor paraspinal 0.37 0.37 0.37 Agree No 95870 Muscle test nonparaspinal 0.37 0.37 0.37 Agree No 95885 Musc tst done w/nerv tst lim 0.35 0.35 0.35 Agree No 95886 Musc test done w/n test comp 0.92 0.92 0.70 Disagree No 95887 Musc tst done w/n tst nonext 0.73 0.73 0.47 Disagree No 95905 Motor &/ sens nrve cndj test 0.05 0.05 0.05 Agree No 95907 Motor&/sens 1-2 nrv cndj tst New 1.00 1.00 Agree No 95908 Motor&/sens 3-4 nrv cndj tst New 1.37 1.25 Disagree Yes 95909 Motor&/sens 5-6 nrv cndj tst New 1.77 1.50 Disagree Yes 95910 Motor&sens 7-8 nrv cndj test New 2.80 2.00 Disagree No 95911 Motor&sen 9-10 nrv cndj test New 3.34 2.50 Disagree No 95912 Motor&sen 11-12 nrv cnd test New 4.00 3.00 Disagree No 95913 Motor&sens 13/> nrv cnd test New 4.20 3.56 Disagree No 95921 Autonomic nrv parasym inervj 0.90 0.90 0.90 Agree No 95922 Autonomic nrv adrenrg inervj 0.96 0.96 0.96 Agree No 95923 Autonomic nrv syst funj test 0.90 0.90 0.90 Agree No 95924 Ans parasymp & symp w/tilt New 1.73 1.73 Agree No 95925 Somatosensory testing 0.54 N/A 0.54 Interim N/A 95926 Somatosensory testing 0.54 N/A 0.54 Interim N/A 95928 C motor evoked uppr limbs 1.50 N/A 1.50 Interim N/A 95929 C motor evoked lwr limbs 1.50 N/A 1.50 Interim N/A 95938 Somatosensory testing 0.86 0.86 0.86 Interim No 95939 C motor evoked upr&lwr limbs 2.25 2.25 2.25 Interim No 95940 Ionm in operatng room 15 min New 0.60 0.60 Agree No 95941 Ionm remote/>1 pt or per hr New 2.00 Invalid N/A N/A G0453 Cont intraop neuro monitor New N/A 0.50 N/A N/A 95943 Parasymp&symp hrt rate test New Contractor Priced Contractor Priced N/A N/A 96920 Laser tx skin < 250 sq cm 1.15 1.15 1.15 Agree No 96921 Laser tx skin 250-500 sq cm 1.17 1.30 1.30 Agree No 96922 Laser tx skin >500 sq cm 2.10 2.10 2.10 Agree No475

HCPCS

Code Short Descriptor CY 2012 Work RVU AMA RUC/HCPAC Recommended

Work RVU* CY 2013 Interim/Interim

Final Work RVU Agree/Disagree with AMA RUC/HCPAC Recommended

Work RVU* CMS Refinement to AMA/HCPAC Recommended Time* 97150 Group therapeutic procedures 0.27 0.29 0.29 Agree No G0456 Neg pre wound <=50 sq cm New N/A Contractor Priced N/A N/A G0457 Neg pres wound >50 sq cm New N/A Contractor Priced N/A N/A 99485 Suprv interfacilty transport New 1.50 Bundled N/A N/A 99486 Suprv interfac trnsport addl New 1.30 Bundled N/A N/A 99487 Cmplx chron care w/o pt vsit New 1.00 Bundled N/A N/A 99488 Cmplx chron care w/ pt vsit New 2.50 Bundled N/A N/A 99489 Complx chron care addl30 min New 0.50 Bundled N/A N/A 99495 Trans care mgmt 14 day disch New 2.11 2.11 Agree No 99496 Trans care mgmt 7 day disch New 3.05 3.05 Agree Yes G0454 MD document visit by NPP New N/A 0.18 N/A N/A *Some of the CPT codes in this table were first reviewed for CY2011 and/or CY2012 and we held them interim pending the receipt of additional information. As a result, for some CPT codes, the AMA RUC/HCPAC recommendation reflects the CY2011 or CY2012 AMA RUC/HCPAC recommendation. For the majority of CPT codes in this table, the values reflect the CY 2013 AMA RUC/HCPAC recommendation. Where N/A is listed, either we did not receive a recommendation from the AMA RUC/HCPAC, the code is not nationally priced, or the code is not separately payable/payable. (1) Integumentary System: Skin, Subc utaneous, and Accessory Structures TABLE 31: Integumentary System: Skin, Subcutaneous, and Accessory Structures

HCPCS

Code Short Descriptor CY 2012 Work RVU AMA RUC/HCPAC Recommended

Work RVU CY 2013 Interim/Interim

Final Work RVU Agree/Disagree with AMA RUC/HCPAC Recommended

Work RVU CMS Refinement to AMA/HCPAC Recommended Time 10120 Remove foreign body 1.25 1.25 1.22 Disagree Yes 11055 Trim skin lesion 0.43 0.43 0.35 Disagree Yes 11056 Trim skin lesions 2 to 4 0.50 0.50 0.50 Agree No 11057 Trim skin lesions over 4 0.79 0.79 0.65 Disagree Yes 11300 Shave skin lesion 0.5 cm/< 0.51 0.60 0.60 Agree No 11301 Shave skin lesion 0.6-1.0 cm 0.85 0.90 0.90 Agree No 11302 Shave skin lesion 1.1-2.0 cm 1.05 1.16 1.05 Disagree No 11303 Shave skin lesion >2.0 cm 1.24 1.25 1.25 Agree No 11305 Shave skin lesion 0.5 cm/< 0.67 0.80 0.80 Agree No 11306 Shave skin lesion 0.6-1.0 cm 0.99 1.18 0.96 Disagree No 11307 Shave skin lesion 1.1-2.0 cm 1.14 1.20 1.20 Agree No 11308 Shave skin lesion >2.0 cm 1.41 1.46 1.46 Agree No 11310 Shave skin lesion 0.5 cm/< 0.73 1.19 0.80 Disagree No 11311 Shave skin lesion 0.6-1.0 cm 1.05 1.43 1.10 Disagree No 11312 Shave skin lesion 1.1-2.0 cm 1.20 1.80 1.30 Disagree No 11313 Shave skin lesion >2.0 cm 1.62 2.00 1.68 Disagree No
CPT code 10120 was identified as potentia lly misvalued using the Harvard-valued-- Utilization over 30,000 screen.476

After clinical review of CPT code 10120 (Incision and removal of foreign body, subcutaneous tissues; simple) we believe that the specialty society survey 25 th percentile work RVU of 1.22 accurately reflects th e work of this service. Medicare claims data from 2011 indicate that this service is t ypically furnished to the benefici ary by the provider on the same day as an E/M visit. We believe that some of the activities furnished during the pre- and post-service period of the procedure code and the E/M visit ov erlap. After review, we believe that the AMA RUC appropriately accounted for this overlap in its recommenda tion of pre-service time, but failed to account for the overlap in post-service time. To account for this overlap, we reduced the AMA RUC-recommended post-service time for this procedure by one-third, from 5 minutes to 3 minutes. We believe that 3 minutes accura tely reflects the post-se rvice time involved in furnishing this procedure and is more in line with similar services. Because we reduced theAMA RUC-recommended procedure time for this code by 2 minutes, given a standard postservice work intensity of .0224 RVUs per minute, we believe that the specialty society survey
25 th percentile work RVU of 1.22 is more appr opriate for this service than the AMA RUCrecommended work RVU of 1.25. In sum, on an interim final basis for CY 2013, we are assigning a work RVU of 1.22 to CPT code 10120, with a refinement to the AMA RUCrecommended time. A complete list of the interim final times associated with this procedure is available on the CMS website at www.cms.gov/physicianfeesched/. CPT code 11056 was identified for review becau se it is on the multispecialty points of comparison (MPC) list—a list of CPT codes commonl y used as reference codes in the valuation of other codes. We reviewed CPT code 11056 (Paring or cu tting of benign hyperkeratotic lesion (eg, corn or callus); 2 to 4 lesions) in CY 2012, and accepted the HCPAC-recommended work RVU of 0.50, the specialty society survey 25 th percentile value, on an in terim basis for CY 2012. At477 that time, we requested that the specialty so ciety re-review CPT code 11056 along with related CPT codes 11055 (Paring or cutting of benign hyperk eratotic lesion (eg, corn or callus); single lesion) and 11057 (Paring or cutting of benign hype rkeratotic lesion (eg, corn or callus); more than 4 lesions) to ensure appr opriate relativity betw een the three services (76 FR 73190). The specialty society declined to survey CPT codes 11055 or 11057, a nd, in its recommendations to CMS, the AMA RUC noted that there are no ap parent rank order anomalies among the three services. For CY 2013, we reviewed CPT codes 11055, 11056, and 11057 together. After clinical review, we did not have evidence that the relativity of the serv ices to each other had changed over time, and since the HCPAC and CMS agreed that the work associated with CPT code 11056 had decreased, we believe it is appropriate to reduce the work of CPT codes 11055 and 11057 relative to the decrease in work of CPT code 11056. In CY 2012, the HCPAC recommended that CPT code 11056 be reduced from a CY 201 1 work RVU of 0.61 to a CY 2012 work RVU of 0.50. Therefore, to maintain relativity, we ar e reducing CPT code 11055 from a work RVU of 0.43 to a work RVU of 0.35, and we are reducin g CPT code 11057 from a work RVU of 0.79 to a work RVU of 0.65 on an interim final basis for CY 2013. Regarding physician time, CPT codes 11055 and 11057 currently (CY 2012) are assigned 2 minutes of pre-service time and 5 minutes of post-service time. Before it was reviewed by the HCPAC for CY 2012, CPT code 11056 was also assi gned 2 minutes of pre-service time and 5 minutes of post service time. Through its re view, the HCPAC recommended adjusting the time of CPT code to include 7 minutes of pre-service time and 2 minutes of pos t-service time, and we agreed. We believe that these are also the appr opriate pre- and post- service times for CPT codes 11055 and 11057. On an interim final basis for CY 2013, we are refining the times of CPT codes 11055 and 11057 to 7 minutes of pre-service time and 2 minutes of post-service time. We478

believe the current intra-service times of 4 minutes for CPT code 11055 and 15 minutes for CPT code 11057 remain appropriate. A co mplete list of the interim fina l times associated with these procedures is available on the CMS website at www.cms.gov/physicianfeesched/. For CY 2013 CPT codes 11300 through 11313, whic h describe procedur es related to the shaving of epidermal or dermal lesions, were surveyed by their related specialty society to establish current relative values for these proc edures. The specialty society and the AMA RUC reviewed the survey results for CPT codes 11300 through 11313 and recommended the survey
25 th percentile work RVU for nearly all the codes in the family. After clinical review, we believe that the survey 25 th percentile for all the codes in the fam ily reflects the appropriate relativity of the services both within the family, as well as relative to other services on the PFS. On an interim final basis for CY 2013 we are as signing a work RVU of 0.60 for CPT code 11300 (Shaving of epidermal or dermal lesion, single le sion, trunk, arms or legs; lesion diameter 0.5 cm or less); a work RVU of 0.90 for CPT code 11301 (S having of epidermal or dermal lesion, single lesion, trunk, arms or legs; lesion diameter 0.6 to 1.0 cm); a work RVU of 1.05 for CPT code 11302 (Shaving of epidermal or dermal lesion, sing le lesion, trunk, arms or legs; lesion diameter 1.1 to 2.0 cm); a work RVU of 1.25 for CPT code 11303 (Shaving of epidermal or dermal lesion, single lesion, trunk, arms or le gs; lesion diameter over 2.0 cm); a work RVU of 0.80 for CPT code 11305 (Shaving of epidermal or dermal lesion, single lesion, scal p, neck, hands, feet, genitalia; lesion diameter 0.5 cm or less); a wo rk RVU of 0.96 for CPT code 11306 (Shaving of epidermal or dermal lesion, single lesion, scalp, n eck, hands, feet, genitali a; lesion diameter 0.6 to 1.0 cm); a work RVU of 1.20 for CPT code 11307 (Shaving of epidermal or dermal lesion, single lesion, scalp, neck, hands, feet, genitalia; lesion diameter 1.1 to 2.0 cm); a work RVU of 1.46 for CPT code 11308 (Shaving of epidermal or dermal lesion, single lesion, scalp, neck, hands, feet, genitalia; lesion diameter over 2.0 cm); a work RVU of 0.80 for CPT code 11310479 (Shaving of epidermal or dermal lesion, single le sion, face, ears, eyelids, nose, lips, mucous membrane; lesion diameter 0.5 cm or less); a work RVU of 1.10 for CPT code 11311 (Shaving of epidermal or dermal lesion, single lesion, face, ears, eyelids, nose, lips, mucous membrane; lesion diameter 0.6 to 1.0 cm); a work RVU of 1.30 for CPT code 11312 (Shaving of epidermal or dermal lesion, single lesion, face, ears, eyelid s, nose, lips, mucous membrane; lesion diameter 1.1 to 2.0 cm); and a work RVU of 1.68 for CPT code 11313 (Shaving of epidermal or dermal lesion, single lesion, face, ears, eyelids, nose, lips, mucous membrane; lesion diameter over 2.0 cm). (2) Integumentary System: Repair (Closure) TABLE 32: Integumentary System: Repair (Closure)

HCPCS

Code Short Descriptor CY 2012 Work RVU AMA RUC/HCPAC Recommended

Work RVU CY 2013 Interim/Interim

Final Work RVU Agree/Disagree with AMA RUC/HCPAC Recommended

Work RVU CMS Refinement to AMA/HCPAC Recommended Time 12035 Intmd wnd repair s/a/t/ext 3.50 3.60 3.50 Disagree No 12036 Intmd wnd repair s/a/t/ext 4.23 4.50 4.23 Disagree Yes 12037 Intmd wnd repair s/tr/ext 5.00 5.25 5.00 Disagree No
12045 Intmd wnd repair nhf/genit 3.75 3.90 3.75 Disagree Yes
12046 Intmd wnd repair nhf/genit 4.30 4.60 4.30 Disagree Yes
12047 Intmd wnd repair nhf/genit 4.95 5.50 4.95 Disagree Yes 12055 Intmd wnd repair face/ mm 4.50 4.65 4.50 Disagree Yes 12056 Intmd wnd repair face/ mm 5.30 5.50 5.30 Disagree Yes 12057 Intmd wnd repair face/ mm 6.00 6.20 6.00 Disagree Yes
13100 Cmplx rpr trunk 1.1-2.5 cm 3.17 3.00 3.00 Agree Yes
13101 Cmplx rpr trunk 2.6-7.5 cm 3.96 3.50 3.50 Agree Yes
13102 Cmplx rpr trunk addl 5cm/< 1.24 1.24 1.24 Agree No 13120 Cmplx rpr s/a/l 1.1-2.5 cm 3.35 3.23 3.23 Agree Yes 13121 Cmplx rpr s/a/l 2.6-7.5 cm 4.42 4.00 4.00 Agree Yes
13122 Cmplx rpr s/a/l addl 5 cm/> 1.44 1.44 1.44 Agree No
13131 Cmplx rpr f/c/c/m/n/ax/g/h/f 3.83 3.73 3.73 Agree Yes
13132 Cmplx rpr f/c/c/m/n/ax/g/h/f 6.58 4.78 4.78 Agree Yes
13133 Cmplx rpr f/c/c/m/n/ax/g/h/f 2.19 2.19 2.19 Agree No480

HCPCS

Code Short Descriptor CY 2012 Work RVU AMA RUC/HCPAC Recommended

Work RVU CY 2013 Interim/Interim

Final Work RVU Agree/Disagree with AMA RUC/HCPAC Recommended

Work RVU CMS Refinement to AMA/HCPAC Recommended Time 13150 Cmplx rpr e/n/e/l 1.0 cm/< 3.85 N/A 3.58 N/A N/A
13151 Cmplx rpr e/n/e/l 1.1-2.5 cm 4.49 4.34 4.34 Agree Yes
13152 Cmplx rpr e/n/e/l 2.6-7.5 cm 6.37 5.34 4.90 Disagree Yes
13153 Cmplx rpr e/n/e/l addl 5cm/< 2.38 2.38 2.38 Agree No

CPT codes 12031, 12051, and 13101 were identified as potentially misvalued using the Harvard-valued—Utilization over 3 0,000 screen. As a result of this screen, in the Fourth FiveYear Review of Work, we revi ewed the family of intermedia te wound repair CPT codes (12031 through 12057), along with two complex wound repair codes (13100 and 13101). In the Fourth Five-Year Review, we disa greed with the AMA RUC-recommended work RVUs for the larger of the intermediate wound repair c odes: CPT codes 12035 (Repair, intermediate, wounds of scalp, ax illae, trunk and/or extremities (e xcluding hands and feet); 12.6 cm to 20.0 cm), 12036 (Repair, intermediate, wounds of scalp, axillae, trunk and/or extremities (excluding hands and feet); 20.1 cm to 30.0 cm), 12037 (Repair, intermed iate, wounds of scalp, axillae, trunk and/or extremities (excluding hands and feet); over 30.0 cm), 12045 (Repair, intermediate, wounds of neck, hands, feet and/or external genitalia; 12.6 cm to 20.0 cm), 12046 (Repair, intermediate, wounds of neck, hands, feet and/or external genitalia; 20.1 cm to 30.0 cm), 12047 (Repair, intermediate, wounds of neck, hands, feet and/or external gen italia; over 30.0 cm), 12055 (Repair, intermediate, wounds of face , ears, eyelids, nose, lips and/or mucous membranes; 12.6 cm to 20.0 cm), 12056 (Repair, in termediate, wounds of face, ears, eyelids, nose, lips and/or mucous membranes; 20.1 cm to 30.0 cm) and 12057 (Repair, intermediate, wounds of face, ears, eyelids, nose, lips and/ or mucous membranes; over 30.0 cm) (76 FR 32431 through 32432). As discussed in the CY 2012 PFS final rule with comment period, after review481 by the refinement panel, we maintained the pr oposed RVUs published in the Fourth Five-Year Review of Work (76 FR 73113 through 73114). We stated that we would hold these codes interim for another year rather th an finalizing the codes, so that we could review these larger intermediate wound repair codes alongside the family complex wound repair codes, which we anticipated reviewing for CY 2013. In the Fourth Five-Year Review of Work, we stated that we would maintain the current (CY 2011) work RVUs and times for complex wound repair CPT codes 13100 (Repair, complex, trunk; 1.1 cm to 2.5 cm) and 13101 (Repair, comple x, trunk; 2.6 cm to 7.5 cm), and requested that the AMA RUC review the entire set of codes in the complex wound repair family together to assess the appropriate gradati on of the work RVUs in the family (76 FR 32434 through 32435). For CY 2013, we received new recommendations from the AMA RUC on CPT codes 13100 and 13101, as well as recommendations on th e rest of the CPT codes in the complex wound repair family CPT codes 13100 through 13102, 13120 through 13122, 13131 through 13133, and 13150 through 13153, excluding CPT code 13150 (Repair, complex, eyelids, nose, ears and/or lips; 1.0 cm or less), which the AM A RUC referred to the CPT Editorial Panel for deletion in CY 2014. We agree with the AMA RU C recommendations for all the codes in the complex wound repair family, except one. Afte r reviewing CPT code 13152 (Repair, complex, eyelids, nose, ears and/or lips; 2.6 cm to 7.5 cm), we believe that the AMA RUC-recommended work RVU of 5.34 is too high relative to sim ilar CPT code 13132 (Repair, complex, forehead, cheeks, chin, mouth, neck, axillae, genitalia, hands and/or feet; 2.6 cm to 7.5 cm ), which has an AMA RUC-recommended work RVU of 4.78, and CPT code 13151 (Repair, complex, eyelids, nose, ears and/or lips; 1.1 cm to 2.5 cm), wh ich has an AMA RUC-recommended work RVU of 4.34. We believe that th e specialty society 25 th percentile work RVU of 4.90 more appropriately reflects the relative work involved in furnishing this service. On an interim final basis for CY482 2013, we are assigning a work RVU of 4.90 to CPT code 13152. The AMA RUC referred CPT code 13150 to the CPT Editorial Panel for deletion in CY 2014. Because of this, the AMA RUC did not review this service with the other codes in this family. For CY 2013, we believe it is appropr iate to reduce the work RVU of CPT code 13150 proportionate to the other services in the family, so that the value of CPT code 13150 maintains appropriate proportionate rank or der for CY 2013. For CY 2013, the work RVUs for the 12 other CPT codes in this family are being redu ced, on average, to 93 pe rcent of their CY 2012 value. Applying that reduction to CPT c ode 13150 results in a CY 2013 work RVU of 3.58, which we believe appropri ately reflects the work associated w ith this procedure. Therefore, on an interim final basis for CY 2013, we are assi gning a work RVU of 3.58 to CPT code 13150. In addition to these work RVU changes, we made small refinements to the AMA RUCrecommended times for many of the CPT codes in this family to ensure consistency between congruent services. A list of th e interim final times associated w ith these procedures is available on the CMS website at www.cms.gov/physicianfeesched/. After reviewing the family of complex wound repair CPT codes for CY 2013, we rereviewed the larger intermediate wound repair codes that we had been holding interim since the Fourth Five-Year Review of Work. We reviewed CPT codes 12035 through 12037, 12045 through 12047, and 12055 through 12057 in relation to each other, the othe r intermediate wound repair CPT codes (12031 through 12034, 12041 through 12044, and 12051 through 12054) , the complex wound repair CPT codes, and other PFS se rvices, and we continue to believe that the current interim values are appropriate relative to the other services. Th erefore, on an interim final basis for CY 2013, are maintaining the following current (CY 2012) work values: a work RVU of 3.50 for CPT code 12035; a work RVU of 4.23 for CPT code 12036; a work RVU of 5.00 for CPT code 12037; a work RVU of 3.75 fo r CPT code 12045; a work RVU of 4.30 for483
CPT code 12046; a work RVU of 4.95 for CPT code 12047; a work RVU of 4.50 for CPT code 12055; a work RVU of 5.30 for CPT code 12056, and a work RVU of 6.00 for CPT code 12057. We also believe that it is appropriate to maintain the current (CY 2012) times for these procedures, as we believe that they reflect the time involved in furnishing these procedures and that they are well-aligned with each other and with the simple and complex wound repair CPT codes. One exception to this is CPT code 12045 (Repair, intermediate, wounds of neck, hands, feet and/or external genitalia; 12.6 cm to 20.0 cm), which includes 10 mi nutes of pre-service evaluation time, while CPT codes 12046 (Repair, intermediate, wounds of neck, hands, feet and/or external genitalia; 20.1 cm to 30.0 cm) an d 12047 (Repair, intermedia te, wounds of neck, hands, feet and/or external genitalia; over 30.0 cm) both incl ude 9 minutes of pre-service evaluation time. We believe it is appropriate to reduce the pre-service evaluation time of CPT code 12045 to match the pre-service evaluati on time of CPT codes 12046 and 12047. Therefore, for CY 2013, we are assigning an interim final pr e-service evaluation time of 9 minutes to CPT 12045. A complete list of the interim final times a ssociated with these pro cedures is available on the CMS website at www.cms.gov/physicianfeesched/. (3) Musculoskeletal System: Spine (Vertebral Column) TABLE 33: Musculoskeletal Sy stem: Spine (Vertebral Column)

HCPCS Code Short Descriptor CY 2012 Work RVU AMA RUC/HCPAC Recommended Work RVU CY 2013 Interim/Interim Final Work RVU Agree/Disagree with AMA RUC/HCPAC Recommended Work RVU CMS Refinement to AMA/HCPAC Recommended Time 22586 Prescrl fuse w/ instr l5/s1 New N/A 28.12 N/A N/A

For CY 2013, the CPT Editorial Panel creat ed CPT code 22586 (Arthrodesis, pre-sacral interbody technique, including disc space pr eparation, discectomy, with posterior instrumentation, with image guidance, includes b one graft when performed, l5-s1 interspace). The specialty societies related to this CPT code that participate in the AMA RUC declined to484 survey this new CPT code and the AMA RUC issued no work RVU recommendation to us for this service for CY 2013. A related specialty so ciety that does not participate in the AMA RUC conducted a survey of its member s regarding the physician work a nd time associated with this procedure and submitted a recommendation to CMS. In determining the appropriate value for this CPT code, we reviewed the survey results and recommendations submitted to us, literature on the procedure, and the Medicare claims data. Ultimately, we used a building block approach based on Medicare 2011 same day billing combinations to develop the interim final value for this procedure. New CPT code 22586 is a bundled lumbar arthr odesis procedure that includes grafting, posterior instrumentation, and fixation. To value this service we used CPT code 22558 (Arthrodesis, anterior interbody technique, including minimal discectomy to prepare interspace (other than for decompression); lumbar) as a refere nce service, as it is a similar procedure but it does not include additional grafting, instrument ation, and fixation. To assess the appropriate relative work increase from unbundled CPT c ode 22558 to the new bundled CPT code 22586, we used Medicare claims data to assess which graf ting, instrumentation, and fixation services are commonly billed with CPT code 22558 and how often. We used those data to create a utilization weighted work RVU for the grafting com ponent of CPT code 22586, the instrumentation component of the 22586, and the fixation compone nt of 22586. We added those components to the base service of CPT code 22558 to create a work RVU of 28.12. We believe this work RVU reflects the appropriate incremen tal difference in work between the base reference CPT code 22558 and new CPT code 22586. For CY 2013 we ar e assigning a work RVU of 28.12 to CPT code 22586 for CY 2013, and we request additional public input on the appropriate valuation of this service. We assigned CPT code 22586 a global period of 90-days, which is consistent with similar485 service. Regarding physician time for CPT code 22586, after reviewing the physician time and post-operative visits for similar services, we believe this serv ice includes 40 minutes of preservice evaluation time, 20 minutes of pre-service positioning tim e, 20 minutes of pre-service scrub, dress and wait time, 180 minut es of intra-service time, and 30 minutes of immediate postservice time. In the post-operative period, we be lieve the typical case for this service includes 2 CPT code 99231 visits, 1 CPT code 99323 visit, 1 CPT code 99238 visit, and 4 CPT code 99213 visits. A list of the interim final times associat ed with this procedure is available on the CMS website at www.cms.gov/physicianfeesched / (4) Musculoskeletal System: Shoulder TABLE 34: Musculoskeletal System: Shoulder

HCPCS

Code Short Descriptor CY 2012 Work RVU AMA RUC/HCPAC Recommended

Work RVU CY 2013 Interim/Interim

Final Work RVU Agree/Disagree with AMA RUC/HCPAC Recommended

Work RVU CMS Refinement to AMA/HCPAC Recommended Time
23350 Injection for shoulder xray 1.00 1.00 1.00 Agree No
23331 Remove shoulder foreign body 7.63 7.63 7.63 Interim No
23332 Remove shoulder foreign body 12.37 12.37 12.37 Interim No 23472 Reconstruct shoulder joint 22.65 22.13 22.13 Interim No
23473 Revis reconst shoulder joint New 25.00 25.00 Interim No
23474 Revis reconst shoulder joint New 27.21 27.21 Interim No 23600 Treat humerus fracture 3.11 3.00 3.00 Agree No

For CY 2013, the CPT Editorial Panel created two new CPT codes for total shoulder revision, CPT code 23473 (Revision of total shou lder arthroplasty, in cluding allograft when performed; humeral or glenoid component) and 23474 (Revision of total shoulder arthroplasty, including allograft when performed; humeral an d glenoid component). The specialty society surveyed these codes along with the other code s in this family, which include CPT codes 23331 (Removal of foreign body, shoulder; deep (eg, neer hemiarthroplasty removal)), 23332 (Removal486 of foreign body, shoulder; complicated (eg, total shoulder)), a nd 23472 (Arthroplasty, glenohumeral joint; total shoulder (glenoid a nd proximal humeral replacement (eg, total shoulder))). After reviewing the survey respons es, the AMA RUC concluded that the descriptors for CPT codes 23331 and 23332 needed revision. The AMA RUC referred CPT codes 23331 and 23332 to the CPT Editorial Panel for further cl arification and recommended that we maintain the current (CY 2012) work RVUs of 7.63 for CPT code 23331, and 12.37 for CPT code 23332 for CY 2013. The AMA RUC recommended the survey 25 th percentile work RVU for the three other services in this family: a work RVU of 22.13 for CPT code 23472; a work RVU of 25.00 for CPT code 23473; and a work RVU of 27.21 for CPT code 23474. We are accepting these work RVUs on an interim basis for CY 2013, and will review CPT codes 23472, 23473, and 23474 alongside CPT codes 23331 and 23332 after the c odes descriptors are changed, to ensure consistency within this family of CPT codes. (5) Musculoskeletal System: Humerus (Upper Arm) and Elbow TABLE 35: Musculoskeletal Syste m: Humerus (Upper Arm) and Elbow

HCPCS

Code Short Descriptor CY 2012 Work RVU AMA RUC/HCPAC Recommended

Work RVU CY 2013 Interim/Interim

Final Work RVU Agree/Disagree with AMA RUC/HCPAC Recommended

Work RVU CMS Refinement to AMA/HCPAC Recommended Time
24160 Remove elbow joint implant 8.00 8.00 8.00 Interim No 24363 Replace elbow joint 22.6 5 22.00 22.00 Interim Yes 24370 Revise reconst elbow joint New 23.55 23.55 Interim No 24371 Revise reconst elbow joint New 27.50 27.50 Interim No

For CY 2013, the CPT Editorial Panel created two new CPT codes for revision of a total elbow arthroplasty, CPT code 24370 (Revision of total elbow arth roplasty, including allograft when performed; humeral or ulnar component ) and CPT code 24371 (Revision of total elbow arthroplasty, including allograft when performed; humeral and ul nar component). The specialty society surveyed these CPT codes along with component CPT codes 24160 (Implant removal;487 elbow joint) and 24363 (Arthroplasty , elbow; with distal humerus a nd proximal ulnar prosthetic replacement (eg, total elbow)). After reviewing the survey responses, the AMA RUC concluded that the descriptor for CPT code 24160 need s revision. The AMA RUC referred CPT code 24160 to the CPT Editorial Panel for revision of the descriptor and recommended that we maintain the current (CY 2012) work RVU of 8.00 for CPT code 24160 for CY 2013. The AMA RUC recommended the survey 25 th percentile work RVU for the th ree other services in this family: a work RVU of 22.00 for CPT code 24363; a work RVU of 23.55 for CPT code 24370; and a work RVU of 27.50 for CPT code 24371. We are accepting these work RVUs on an interim basis for CY 2013, and will review CPT codes 24363, 24370, and 24371 alongside CPT code 24160 after the code descriptor is changed, to ensure consistency within this family of CPT codes. For CY 2013, we are refining the AM A RUC-recommended post- service time of CPT code 24363 to 20 minutes, from 30 minutes, to ma tch the post-service tim es of CPT code 24370 and 24371. A complete list of the interim final times associated with these procedures is available on the CMS website at www.cm s.gov/physicianfeesched/.

(6) Musculoskeletal System: Appli cation of Casts and Strapping TABLE 36: Musculoskeletal System: A pplication of Casts and Strapping

HCPCS

Code Short Descriptor CY 2012 Work RVU AMA RUC/HCPAC Recommended

Work RVU CY 2013 Interim/Interim

Final Work RVU Agree/Disagree with AMA RUC/HCPAC Recommended

Work RVU CMS Refinement to AMA/HCPAC Recommended Time
29075 Application of forearm cast 0.77 0.77 0.77 Agree No
29581 Apply multlay comprs lwr leg 0.25 0.60 0.25 Disagree No
29582 Apply multlay comprs upr leg 0.35 0.35 0.35 Agree No
29583 Apply multlay comprs upr arm 0.25 0.25 0.25 Agree No
29584 Appl multlay comprs arm/hand 0.35 0.35 0.35 Agree No488
For CY 2013, the CPT Editorial Panel revi sed the descriptor of CPT code 29581, and created CPT codes 29582, 29583, and 29584 to desc ribe the applica tion of multi-layer compression to the upper and lower extremities. The CPT Editorial Panel and AMA RUC concluded that the revisions to the descriptor for CPT code 29581 were editorial only, and the AMA RUC related specialty society (Society for Vascular Surgery) believed that resurveying CPT code 29581 was not necessary. As such, the AMA RUC recommended "No Change" for CPT code 29581. For CY 2012, CPT codes 29582, 29583, and 29584 were surveyed through the American Physical Therapy Association (the exp ected dominant providers of the services), and the HCPAC reviewed the results and issued recommendations to CMS for these three CPT codes. We discussed CPT codes 29581 (Application of multi-layer compression system; leg (below knee), including ankle and foot), 29582 (A pplication of multi-layer compression system; thigh and leg, including ankle and foot, when performed), 29583 (Application of multi-layer compression system; upper arm and forearm) , and 29584 (Application of multi-layer compression system; upper arm, forearm, hand, and fingers) in the CY 2012 final rule with comment period (76 FR 73192 through 73193). In the CY 2012 PFS final rule with comment period, we stated that after clin ical review, we believed that CPT code 29581, in relation to CPT codes 29582 through 29584, described a similar serv ice from a resource pe rspective and should be valued similarly to those codes. We stat ed that we believed a work RVU of 0.60 for CPT code 29581 is inappropriately high in relati on to the HCPAC-reviewed codes 29582, 29583, and 29584. We believed that the HCPAC-recomme nded work RVUs of 0.35 for CPT code 29682, 0.25 for CPT code 29583, and 0.35 for CPT code 29584 accu rately reflected the work associated with these services. Additionally, we stated that we believed that the clinical conditions treated by CPT codes 29581 and 29583 are essentially the same , namely the treatment of venous ulcers489 and lymphedema. We stated that we recognized that there would be mild differences and variation in the application of a multi-layer comp ression system to the upper extremity versus the lower extremity, which is accounted for in the intra-service times of the codes. As such, we believed that a work RVU of 0.25 appropriately a ccounts for the work associated with CPT code
29581. Ultimately, we stated that we believed that a survey that addressed all 4 CPT codes together as a family and gathers responses from all clinicians who furnish the services described by CPT codes 29581 through 29584 would help us to fu rther consider the a ppropriate gradation in valuation of these 4 services. We assi gned a work RVU of 0.25 to CPT code 29581 on an interim basis for CY 2012, and anticipated reviewing CPT code 29581 along with CPT codes 29582, 29583, and 29584 with new survey data for CY 2013. In response to the CY 2012 PFS final rule wi th comment period, co mmenters stated that they believe the CPT Editorial Panel revisions to CPT code 29581 were editorial only and resurveying CPT code 29581 was unnecessary, and no changes should be made to the work RVU for this code. Commenters disagreed with our methodology to value CPT code 29581 similar to HCPAC-reviewed codes 29582, 29583, and 29584, stati ng that the beneficiaries who receive services under CPT code 29581 are more complex. Commenters noted that the work descriptor for CPT code 29581 includes evaluation and cleansing of the venous ulcer, while there is no such parallel service for CPT codes 29582, 29583, a nd 29584. Commenters argued that CPT code 29581 was reviewed by the AMA RUC in April 2009 and those survey results should not be invalided by crosswalking CPT code 29581 to HCPAC-reviewed codes 29582, 29583, and 29584. Commenters noted that no completed RUC su rvey data was submitted to the HCPAC for CPT codes 29582, 29583 or 29584--a single specialty pr esented crosswalk values to the HCPAC, and they were accepted. Commenters recomm ended we maintain the 2009 valued AMA RUC490

work RVU of 0.60 for CPT code 29581. In response to our assertion that a survey that addressed all 4 CP T codes together as a family and gathers responses from all clinicia ns who furnish the serv ices described by CPT codes 29581 through 29584 would help assure the appropriate gradation in valuation of these 4 services, the AMA RUC noted that when CPT codes 29582, 29583, and 29584 were created no physician (MD/DO) specialty societies had an inte rest in surveying the codes, so they were surveyed and reviewed by only the HCPAC. Th e AMA RUC noted that another survey process would not mean that these codes would be surveyed together as we had requested.In response to comments received, we referred CPT code 29581 to the CY 2012 multispecialty refinement panel for further review. The refinement panel median work RVU for CPT code 29581 was 0.50. Typically, we finalize the work values for CPT codes after reviewing the results of the refinement panel. However, for CY 2012 we assigned interim RVUs for CPT codes 29581, 29582, 29583, and 29584 and requested additi onal information, with the intention of re-reviewing the services for CY 2013 with th e new information we had received, and setting interim final values at that time. We rec ognize that CPT code 29581 received only editorial changes; however, we continue to belie ve the HCPAC-reviewed codes 29582, 29583, and 29584 describe similar services. While the services are performed by differe nt specialties, they do involve similar work. For example, prior to the application of the compression bandage, CPT code 29581 includes the work furnishing a physical ex am to assesses adequate arterial flow, the presence of infection, the degree of swelling, an d the size/depth of the lower extremity ulcer, while CPT code 29583 includes the work of fu rnishing a physical exam to assesses skin integrity, cardiopulmonary status, and peripheral vascular status. We believe these services involve the same amount of physician work. Th erefore, after consid eration of the public comments, refinement panel results, and our clin ical review we continue to believe that the491 crosswalk methodology is appropriate to valu e CPT code 29581 and the resulting work RVU accurately reflects the work associat ed with this service. Accord ingly, on an interim final basis for CY 2012, we are assigning a work RVU of 0.25 to CPT code 29581; a work RVU of 0.35 to CPT code 29582; a work RVU of 0.25 to CPT code 29583; and a work RVU of 0.35 to CPT code 29584. (7) Musculoskeletal System: Endoscopy/Arthroscopy TABLE 37: Musculoskeletal Sy stem: Endoscopy/Arthroscopy

HCPCS

Code Short Descriptor CY 2012 Work RVU AMA RUC/HCPAC Recommended

Work RVU CY 2013 Interim/Interim

Final Work RVU Agree/Disagree with AMA RUC/HCPAC Recommended

Work RVU CMS Refinement to AMA/HCPAC Recommended Time
29824 Shoulder arthroscopy/surgery 8.98 8.98 8.98 Interim No
29826 Shoulder arthroscopy/surgery 3.00 3.00 3.00 Interim No
29827 Arthroscop rotator cuff repr 15.59 15.59 15.59 Interim No
29828 Arthroscopy biceps tenodesis 13.16 13.16 13.16 Interim No

CPT codes 29824, 29826, 29827, and 29828 were identi fied as potentially misvalued through the Codes Reported Togeth er 75 percent or More screen. CPT code 29826 was also identified as potentially misvalued through th e Harvard-valued—Utiliz ation over 30,000 screen, and CPT code 29828 was also identified for additional review because it was on the New Technology list. We reviewed CPT code 29826 (Arthrosc opy, shoulder, surgical; decompression of subacromial space with partial acromioplasty, with coracoacromial ligament (ie, arch) release, when performed (list separately in addition to code for primary procedure)) for CY 2012 and agreed with the AMA RUC recommended work R VU of 3.00, which was the specialty society survey 25 th percentile work RVU (76 FR 73193). Fo r CY 2013, the AMA RUC reviewed CPT codes 29824 (Arthroscopy, shoulder, surgical; distal claviculecto my including distal articular492 surface (mumford procedure)) and 29827 (Arthros copy, shoulder, surgical; with rotator cuff repair), however the specialty society did not survey these CPT codes. Without survey information, the AMA RUC affirmed that th e current work RVU of 8.82 for CPT code 29824 and the current work RVU of 15.59 for CPT co de 29827 are correct and not overlapping with CPT code 29826. For CY 2013, the AMA RUC al so reviewed CPT code 29828 (Arthroscopy, shoulder, surgical; biceps tenodesis), which, as stated above, was on the New Technology list. The specialty society surveyed CPT code 29828, and the AMA RUC recommended the current a work RVU of 13.16, which was between the survey 25 th percentile and median work RVU. As we have stated many times, we believe families of services should be reviewed together to ensure relativity between the services and c onsistency in inputs. We do not find the AMA RUC’s affirmation that the work RVUs of CPT codes 29824 and 29827 have not changed to be sufficient evidence that the current RVUs continue to accurately reflect the work associated with furnishing those services. We request addi tional information from commenters on the appropriate values for these services. To clarif y, we do not believe the specialty society needs to resurvey CPT codes 29826 and 29828, however we would welcome data on the valuation of CPT codes 29824 and 29827. We anticipate re-reviewing th is family of services together for CY 2014. On an interim basis for CY 2013, we are assigning the current (CY 2012) work RVUs to these four services: a work R VU of 8.98 to CPT code 29824; a work RVU of 3.00 to CPT code 29826; a work RVU of 15.59 to CPT code 29827; and a work RVU of 13.16 to CPT code 29828. (8) Respiratory System: Accessory Sinuses TABLE 38: Respiratory System: Accessory Sinuses

HCPCS

Code Short Descriptor CY 2012 Work RVU AMA RUC/HCPAC Recommended

Work RVU CY 2013 Interim/Interim

Final Work RVU Agree/Disagree with AMA RUC/HCPAC Recommended

Work RVU CMS Refinement to AMA/HCPAC Recommended Time 31231 Nasal endoscopy dx 1.10 1.10 1.10 Agree Yes493

CPT code 31231 was identified for review because it is on the MPC list. After clinical review of CPT code 31231 (Nasal endoscopy, dia gnostic, unilateral or bilateral (separate procedure)) we believe that the cu rrent work RVU of 1.10, the survey 25 th percentile value and the AMA RUC recommendation accurately reflects the work asso ciated with this procedure. Medicare claims data from 2011 indicate that this service is typically furn ished to the beneficiary on the same day as an E/M visit. We believe that some of the activities furnished during the preand post-service period of the procedure code and the E/M visit overlap. After review, we believe that the AMA RUC appropriately accounte d for this overlap in its recommendation of pre-service time, but failed to account for the overl ap in post-service time. To account for this overlap, we reduced the AMA RUC-recommended post-service time for this procedure by onethird, from 5 minutes to 3 minut es. We believe 3 minutes accu rately reflects the post-service time involved in furnishing this proc edure, and is more in line with similar services. A complete list of the interim final times associated with th is procedure is available on the CMS website at www.cms.gov/physicianfeesched/. (9) Respiratory System: Trachea and Bronchi TABLE 39: Respiratory System: Trachea and Bronchi

HCPCS

Code Short Descriptor CY 2012 Work RVU AMA RUC/HCPAC Recommended

Work RVU CY 2013 Interim/Interim

Final Work RVU Agree/Disagree with AMA RUC/HCPAC Recommended

Work RVU CMS Refinement to AMA/HCPAC Recommended Time 31647 Bronchial valve init insert New 4.40 4.40 Agree No 31648 Bronchial valve addl insert New 4.20 4.20 Agree No 31649 Bronchial valve remov init New 2.00 1.44 Disagree No
31651 Bronchial valve remov addl New 1.58 1.58 Agree No 31660 Bronch thermoplsty 1 lobe New 4.50 4.25 Disagree No
31661 Bronch thermoplsty 2/> lobes New 5.00 4.50 Disagree No

For CY 2013, the CPT Editorial Panel created CPT codes 31647, 31648, 31649, and 31651 to replace 0250T, 0251T and 0252T; as well as CPT codes 31660 and 31661 to replace494

0276T and 0277T. After clinical review, we agree with th e AMA RUC-recommended work RVU of 4.40 for CPT code 31647 (Bronchoscopy, rigid or flexible , including fluoroscopic guidance, when performed; with balloon occlus ion, when performed, assessment of air leak, airway sizing, and insertion of bronchial valve(s) , initial lobe) and the AMA RUC recommended work RVU of 1.58 for CPT code 31651 (Bronchoscopy, rigid or flex ible, including fluoroscopic guidance, when performed; with balloon occlus ion, when performed, assessment of air leak, airway sizing, and insertion of bronchial valve(s), each additional lobe (list separa tely in addition to code for primary procedure[s])) which is the associated add-on code for CPT code 31647. We also agree with the AMA RUC-recommended RVU of 4.20 for CPT code 31648 (Bronchoscopy, rigid or flexible, including fluoroscopic guidance, when pe rformed; with removal of bronchial valve(s), initial lobe), which is somewh at less work than CPT code 31647. We do not agree with the AMA RUC-recommended work RVU of 2.00 fo r CPT code 31649 (Bronchoscopy, rigid or flexible, including fluoroscopic guidance, when pe rformed; with removal of bronchial valve(s), each additional lobe (list separately in addition to code for primary procedure)). CPT code 31647 has a higher work RVU than CPT code 31648, so to maintain the ap propriate relativity between these services, we believe that the a dd-on code associated w ith CPT code 31647 (which is CPT code 31651) should have a higher RVU than the add-on code associated with CPT code 31648 (which is CPT code 31649). As su ch, we believe that the survey 25 th percentile work RVU of 1.44 for CPT code 31649 places these servic es in the appropriate rank-order. On an interim final basis for CY 2013 we are assi gning a work RVU of 4.40 to CPT code 31647; a work RVU of 4.20 to CPT code 31648; a work RVU of 1.44 to CPT code 31649; and a work RVU of 1.58 to CPT code 31651. After reviewing CPT codes 31660 (Bronchos copy, rigid or flexible, including495 fluoroscopic guidance, when performed; with bronchial thermoplasty, 1 lobe) and 31661 (Bronchoscopy, rigid or flexible, including fluor oscopic guidance, when performed; with bronchial thermoplasty, 2 or more lobes) we believe that the specialty society survey 25 th percentile work RVUs of 4.25 for CPT code 31660 and 4.50 for CPT code 31661 appropriately reflect the relativity of these services to each other and to other fee sc hedule services. The AMA RUC recommended the specialty society survey median work RVUs of 4.50 for CPT code 31660 and 5.00 for CPT code 31661. On an interim fina l basis for CY 2013, we are assigning a work RVU of 4.25 for CPT code 31660 and a work RVU of 4.50 to CPT code 31661.

(10a) Respiratory System: Lungs and Pleura TABLE 40: Respiratory System: Lungs and Pleura

HCPCS

Code Short Descriptor CY 2012 Work RVU AMA RUC/HCPAC Recommended

Work RVU CY 2013 Interim/Interim

Final Work RVU Agree/Disagree with AMA RUC/HCPAC Recommended

Work RVU CMS Refinement to AMA/HCPAC Recommended Time 32551 Insertion of chest tube 3.29 3.50 3.29 Disagree No
32554 Aspirate pleura w/o imaging New 1.82 1.82 Agree No
32555 Aspirate pleura w/ imaging New 2.27 2.27 Agree Yes
32556 Insert cath pleura w/o image New 2.50 2.50 Agree No
32557 Insert cath pleura w/ image New 3.62 3.12 Disagree Yes
32701 Thorax stereo rad targetw/tx New 4.18 4.18 Agree No

CPT codes 32420, 32421, 32422, and 32551 were identi fied as potentially misvalued through the Harvard-valued—Util ization over 30,000 screen. Fo r CY 2013, the CPT Editorial Panel deleted CPT codes 32420, 32421, and 32422 and replaced them with CPT codes 32554, 32555, 32556, and 32557. After clinical review of CPT code 32551 (Tube thoracostomy, in cludes connection to drainage system (eg, water seal), when performe d, open (separate procedure)), we believe that496 the current work RVU of 3.29 appropr iately reflects the work associ ated with service. The AMA RUC recommended the specialty society survey 25 th percentile work RVU of 3.50, however we believe that an increase in work RVU is not warranted for this service, especially considering the substantial drops in recommended physician time. Additionally, we believe that a work RVU of 3.29 places this service in the appropriate rank or der with the other similar CPT codes reviewed for CY 2013. On an interim final basis for CY 2013, we are assigning a work RVU of 3.29 for CPT code 32551. After clinical review of CPT codes 32554 (Thora centesis, needle or catheter, aspiration of the pleural space; without imaging guidance), 32555 (Thoracentesis, needle or catheter, aspiration of the pleural space; with imag ing guidance), and 32556 (Pleural drainage, percutaneous, with insertion of indwelling cathete r; without imaging guidance) we agree with the AMA RUC-recommended work RVUs. On an inte rim final basis for CY 2013, we are assigning a work RVU of 1.82 to CPT code 32554; a work RVU of 2.27 to CPT code 32555, and a work RVU of 2.50 to CPT code 32556. After clinical review of CPT code 32557 (Ple ural drainage, percutaneous, with insertion of indwelling catheter; with imaging guidanc e), we believe that a work RVU of 3.12 appropriately reflects the work of this serv ice. The AMA RUC recommended a work RVU of 2.50 for CPT code 32556 and a work RVU of 3. 62 for CPT code 32557. We believe the AMA RUC-recommended work RVU of 3.62 overstate s the difference between CPT codes 32556 and 32557. The specialty societies that surveyed CPT code 32556 recommended to the AMA RUC a work RVU of 3.00 for CPT code 32556 and a work RVU of 3.62 for CPT code 32557. We believe this difference in work RVU of 0.62 mo re accurately captures the relative difference between these two services. Therefore, since we assigned CPT code 32556 an interim final work RVU of 2.50, we believe a work RVU of 3.12 ap propriately reflects the work of CPT code497
32557. On an interim final basis for CY 2013, we are assigning a work RVU of 3.12 to CPT code 32557. Additionally, on an interim final basis fo r CY 2013, we are refining the AMA RUC recommended pre-service evaluation time to 13 minutes from 15 minutes for CPT codes 32555 and 32557 to match the pre-service evalua tion times of CPT codes 32554 and 32556. A complete list of the times associated with thes e procedures is available on the CMS website at www.cms.gov/physicianfeesched/

. (10b) Respiratory System: Lungs and Pleura TABLE 41: Respiratory System: Lungs and Pleura

HCPCS

Code Short Descriptor CY 2012 Work RVU AMA RUC/HCPAC Recommended

Work RVU CY 2013 Interim/Interim

Final Work RVU Agree/Disagree with AMA RUC/HCPAC Recommended

Work RVU CMS Refinement to AMA/HCPAC Recommended Time
32440 Remove lung pneumonectomy 27.28 N/A 27.28 Interim N/A 32480 Partial removal of lung 25.82 N/A 25.82 Interim N/A 32482 Bilobectomy 27.44 N/A 27.44 Interim N/A 32491 Lung volume reduction 25.24 N/A 25.24 Interim N/A
32663 Thoracoscopy w/lobectomy 24.64 24.64 24.64 Interim No
32668 Thoracoscopy w/w resect diag 3.00 4.00 3.00 Interim No
32669 Thoracoscopy remove segment 23.53 23.53 23.53 Interim No
32670 Thoracoscopy bilobectomy 28.52 28.52 28.52 Interim No
32671 Thoracoscopy pneumonectomy 31.92 31.92 31.92 Interim No 32672 Thoracoscopy for lvrs 27.00 27.00 27.00 Interim No
32673 Thoracoscopy w/thymus resect 21.13 21.13 21.13 Interim No
60520 Removal of thymus gland 17.16 N/A 17.16 Interim N/A
60521 Removal of thymus gland 19.18 N/A 19.18 Interim N/A
60522 Removal of thymus gland 23.48 N/A 23.48 Interim N/A

The CPT Editorial Panel review ed the lung resection family of codes and deleted 8 codes, revised 5 codes, and created 18 new codes for CY 2012. During our clinical review for the CY498 2012 PFS final rule with comment period, we were concerned with the varying differentials in the AMA RUC-recommended work RVUs and times between some of the open surgery lung resection codes and their endoscopic analogs. Ra ther than assign alternate interim final RVUs and times in this large restructured fa mily of codes, we accepted the AMA RUC recommendations on an interim basis and request ed that the AMA RUC re-review the surgical services along with their endoscopic analogs. In the CY 2012 PFS final rule with comment period we made this request on a code-bycode basis. However, there was an inadverten t typographical error in ou r request---we referred to “open heart surgery analogs”, instead of just “open surgery analogs”. For example, we stated, “For CPT code 32663 (Thoracoscopy, surgical; w ith lobectomy (single lobe)), the AMA RUC recommended a work RVU of 24.64. Upon clinical review, we have determined that it is most appropriate to accept the AMA RUC recommended work RVU of 24.64 on a provisional basis, pending review of the open heart surgery an alogs, in this case CPT code 32480. We are requesting the AMA RUC look at the incremental difference in RVUs and times between the open and laparoscopic surgeries and recommend a consistent valuation of RVUs and time for CPT code 32663 and other services w ithin this family with this same issue. Accordingly, we are assigning a work RVU of 24.64 for CPT code 32663 on an interim basis for CY 2012” (76 FR 73195). In response to this request, the specialty so ciety noted that thes e are not open heart surgery codes and therefore are not relevant. The AMA RUC requested further information from CMS on why these services should be reviewed as part of a family. We understand that our request would have been more clear if we had re ferred to “open surgery codes” instead of “open heart surgery codes” and if we had written “en doscopic procedures” instead of “laparoscopic surgeries”. With this clarification, we re-re quest public comment on th e appropriate work RVU499

and time values for the interim codes in the tabl e above. These codes ar e discussed in greater detail in the CY 2012 PFS final rule with comment period, pages 73193 through 73195. For CY 2013, we are maintaining the current (CY 2012) values for these services on an interim basis. We intend to review these CPT codes in CY 2013 and set interim final values for CY 2014. (11) Cardiovascular System: Heart and Pericardium TABLE 42: Cardiovascular System: Heart and Pericardium

HCPCS

Code Short Descriptor CY 2012 Work RVU AMA RUC/HCPAC Recommended

Work RVU CY 2013 Interim/Interim

Final Work RVU Agree/Disagree with AMA RUC/HCPAC Recommended

Work RVU CMS Refinement to AMA/HCPAC Recommended Time 33361 Replace aortic valve perq New 29.50 25.1 3 Disagree Yes 33362 Replace aortic valve open New 32.00 27.5 2 Disagree Yes 33363 Replace aortic valve open New 33.00 28.5 0 Disagree Yes 33364 Replace aortic valve open New 34.87 30.0 0 Disagree Yes 33365 Replace aortic valve open New 37.50 33.12 Disagree No
33367 Replace aortic valve w/byp New 11.88 11.88 Agree No
33368 Replace aortic valve w/byp New 14.39 14.39 Agree No
33369 Replace aortic valve w/byp New 19.00 19.00 Agree No
33405 Replacement of aortic valve 41.32 41.32 41.32 Interim No
33430 Replacement of mitral valve 50.93 50.93 50.93 Interim No 33533 Cabg arterial single 33.75 34.98 33.75 Interim No 33990 Insert vad artery access New 8.15 8.15 Agree No 33991 Insert vad art&vein access New 11.88 11.88 Agree No
33992 Remove vad different session New 4.00 4.00 Agree No
33993 Reposition vad diff session New 4.17 3.51 Disagree No
The CPT Editorial Panel deleted four Categor y III codes (0256T through 0259T) and approved nine CPT codes (33361 through 33369) to report tr anscatheter aortic valve replacement (TAVR) procedures for CY 2012. On May 1, 2012, CMS issued a National Covera ge Determination (NCD ) covering TAVR under Coverage with Evidence Development (CED). Th e NCD identifies numerous detailed requirements, including that covered TAVR requires a cardiothoracic surgeon and an interventional cardiologist. Under500
this CED, coverage is limited to services furnished under specific conditions targ eted to developing data on the safety and efficacy of the service for Medicare beneficiaries. Like their predecessor Category III codes (0256T through 0259T), the new Category I CPT codes 33361 through 33365 require the work of an interventional cardiologist and cardiothoracic surgeon to jointly participate in the intra-operative technical aspects of TAVR as co-surgeons. Claims processi ng instructions for the CED (CR 7897 transmittal 2552) require each physician to bill with modifier- 62 indicating that co-surgery payment applies. Medicare pays each co-surgeon 62.5 percent of the fee schedule amount. The three add-on cardiopulmonary bypass support services (CPT codes 3336 7 through 33369) are only reported by the cardiothoracic surgeon; therefore the AMA RUC-recommended work RVUs for those services reflect only the work of one physician. The AMA RUC-recommended work RVUs for each of the co-surgery CPT codes (33361 through 33365) reflect the combined wo rk of both physicians, irrespective of the cosurgery payment policy. We debated whether it was a ppropriate to continue our co-surgery payment policy at 62.5 percent of the physician fee schedule amount for each physician for these codes if the work value reflected 100 percent of the work for two physicians. Ultimately, we decided to set work RVU values to reflect the total physician work of the procedures, an d to continue to follow our co-surgery payment policy allowing the services to be billed by two physicians, in part because co-surge ry is a requirement under Medicare policy for these services. We are not sure th is is the appropriate long-term payment policy. We intend to reassess payment for this family of codes when we review national coverage for TAVR. For the time package, the AMA RU C accounted for the time each physician separately spends obtaining consent and reviewing the procedure with the patient. We are concerned that ti me for each physician to obtain consent and review the procedure with the patient is in consistent with a framework for valuing the service as a single service. After clinical review of CPT code 33361 (Tra nscatheter aortic valve replacement (TAVR/TAVI) with prosthetic valve; percutaneous femoral artery ap proach), we believe that the specialty society survey
25 th percentile work RVU of 25.13 appropriately capture s the total work of the service. The AMA RUC recommended the survey median work RVU of 29.50. Regarding physician time, for CPT 33361, as well as CPT codes 33362 through 33364, we believe 45 mi nutes of pre-service evaluation time, which is the501
survey median time, is more consistent with th e work of this service than the AMA RUC-recommended pre-service evaluation time of 50 minutes. Accordingly, we are assigning a work RVU of 25.13 to CPT code 33361, with a refinement of 45 minutes of pre-service evaluation time, on an interim basis for CY 2013. A complete listing of the times associated with this code is available on the CMS website at: www.cms.gov/PhysicianFeeSched/. After clinical review of CPT code 33362 (Tra nscatheter aortic valve replacement (TAVR/TAVI) with prosthetic valve; open femoral artery approach ), we believe that the sp ecialty society survey 25 th percentile work RVU of 27.52 appropriately captures the total work of the service. The AMA RUC recommended the survey median work RVU of 32.00. Like CPT code 33361, we also believe 45 minutesof pre-service evaluation time is more appropriate for this service than the AMA RUC-recommended preservice evaluation time of 50 minutes. Accordingly, we are assigning a work RVU of 27.52 to CPT code 33362, with a refinement to 45 minutes of pre-service evaluation time, on an interim basis for CY 2013. A complete listing of the times associated with th is code is available on the CMS website at www.cms.gov/PhysicianFeeSched/

. After clinical review of CPT code 33363 (T ranscatheter aortic valve replacement (TAVR/TAVI) with prosthetic valve; open axillary artery approach ), we believe that the specialty society survey 25 th percentile work RVU of 28.50 appr opriately captures the total work of the service. The AMA RUC reviewed the survey results and recommended the su rvey median work RVU of 33.00. Like CPT codes 33361 and 33362, we also believe 45 minut es of pre-service evaluation time is more appropriate for this service than the AMA RUC-recommended time of 50 minutes. Accordingly, we are assigning a work RVU of 28.50 to CPT code 33363, with a refinement to 45 minutes of pre-service evaluation time, on an interim basis for CY 2013. A complete listing of the times associated with this code is available on the CMS website at www.cms.gov/PhysicianFeeSched/

. After clinical review of CPT code 33364 (T ranscatheter aortic valve replacement (TAVR/TAVI) with prosthetic valve; open iliac artery approach), we believe that the specialty society survey 25 th percentile work RVU of 30.00 more appropriately captures the total work of the service. The AMA RUC reviewed the survey results and recommended the su rvey median work RVU of 34.87. Like CPT codes502
33361 through 33363, we also believe 45 minutes of pre-service evaluation time is more appropriate for this service than the AMA RUC-recommended time of 50 minutes. Accordingly, we are assigning a work RVU of 30.00 to CPT code 33364, with a refinement to 45 minutes of pre-service evaluation time, on an interim basis for CY 2013. A complete listing of the times associated with this code is available on the CMS website at: www.cms.gov/PhysicianFeeSched/

. After clinical review of CPT code 33365 (Transcatheter aortic valve replacement (TAVR/TAVI) with prosthetic valve; tran saortic approach (eg, median sternotomy, mediastinotomy), we believe a work RVU of 33.12 accurately reflects the work associated with this service. The AMA RUC re viewed the survey results and recommended the survey median work RVU of 37.50. After clinical review, we determined that th e work associated with this service is very similar to reference CPT code 33410 (Replacement, aortic valve, with cardiopulmonary bypass; with st entless tissue valve) (work R VU = 46.41), which has a 90-day global period that includes i npatient hospital and office visits . Because CPT code 33365 has a 0- day global period that does not include post-operative vi sits, we calculated th e value of the preoperative and post-operative visi ts in the global period of CPT code 33410, which totaled 13.29 work RVUs, and subtracted that from the total work RVU of 46.41 for CPT code 33410 to determine the appropriate work RVU for CPT code 33365. With regard to time, we decided to maintain the 50 minutes of pre-service evaluati on time because we believe that the procedure described by CPT code 33365 involves more pre-se rvice evaluation time si nce it is performed by surgically opening the chest via median sternot omy. Accordingly, we ar e assigning a work RVU of 33.12 for CPT code 33365 on an interim basis for CY 2013. CPT codes 33405, 33430, and 33533 were identified as potentially misvalued through the High Expenditure Procedure Code screen. When reviewing these services, the specialty society utilized data from the Society of Thoracic Surgeons (STS) National Adult Cardiac Database in developing recommended times503 and RVUs for CPT codes 33405 (Replacement, aortic valve, with cardiopulmonary bypass; with prosthetic valve other than homograft or stentles s valve), 33430 (Replacement, mitral valve, with cardiopulmonary bypass), and 33533 (Coronary artery bypass, using arteri al graft(s); single arterial graft), and did not conduct a survey of physician work and time. After reviewing the mean procedure times for these services in the STS database alongside other information relating to the value of these services, the specialty society and AMA RUC concluded that CPT codes 33405 and 33430 are valued appropriately and that the current work RVUs of 41.32 for CPT code 33405, and 50.93 for CPT code 33430 should be maintained. After reviewing the mean procedure time for CPT code 33533 in the STS data base alongside other information relating to the value of the service, the specialty society and AMA RUC concluded that the work associated with CPT code 33553 had increased since this service was last revi ewed. The AMA RUC recommended a work RVU of 34.98 for CPT code 33533, which is a direct crosswalk to CPT code 33510 (Coronary artery bypass, vein only; single coronary venous graft). We believe the STS database, which captures out come data in addition to time and visit data, is a useful resource in the valuat ion of PFS services. However, the AMA RUC recommendations on these services show only the STS database mean time for CPT codes 33405, 33430, and 33533. We are interested in seeing the distribution of times, including the
25 th percentile, median, and 75 th percentile values (w hich are the data points reported on the specialty society surveys), in ad dition to any other information STS believes would be relevant to the valuation of the services , such as case-mix, or time data for similar services. The STS database is a robust source of information a nd we believe it would be helpful to review additional data points for these three services beyond the mean time provided by the AMA RUC. In order to complete our clinical review of these services, we w ould like to see the distribution of procedure times for CPT codes 33405, 33430, and 33533. We are also interested in more504 information on the methodology used to develop the recommended work RVUs based on the time data, and, using that methodology, the di fferent RVUs that correspond to the 25 th percentile, median, and 75 th percentile time data. We previously have expressed our concerns regarding the manner in which data derived from the STS database was used (71 FR 37224 through 37225). We are committed to reviewing and evaluating all services using an approach that maintains the appropriate relativity among fee sc hedule services. For CY 2013 we are maintaining the current work RVUs for these services on an interim basi s. We will consider additional time and other data submitted in response to comments on this final rule with comme nt period in the CY 2014 PFS final rule with comment period. Specificall y, we are maintaining a work RVU of 41.32 for CPT code 33405; a work RVU of 50.93 for CPT code 33430; and a work RVU of 33.75 for CPT code 33533. (12) Cardiovascular Syst em: Arteries and Veins TABLE 43: Cardiovascular System: Arteries and Veins

HCPCS

Code Short Descriptor CY 2012 Work RVU AMA RUC/HCPAC Recommended

Work RVU CY 2013 Interim/Interim

Final Work RVU Agree/Disagree with AMA RUC/HCPAC Recommended

Work RVU CMS Refinement to AMA/HCPAC Recommended Time 35475 Repair arterial blockage 9.48 6.60 5.75 Disgaree No 35476 Repair venous blockage 6.03 5.10 4.71 Disagree No 36221 Place cath thoracic aort a New 4.51 4.17 Disagree Yes 36222 Place cath carotid/inom ar t New 6.00 5.53 Disagree Yes 36223 Place cath carotid/inom ar t New 6.50 6.00 Disagree Yes 36224 Place cath carotd art New 7.55 6.50 Disagree Yes 36225 Place cath subclavian ar t New 6.50 6.00 Disagree Yes 36226 Place cath vertebral ar t New 7.55 6.50 Disagree Yes 36227 Place cath xtrnl carotid New 2.32 2.09 Disagree No 36228 Place cath intracranial art New 4.25 4.25 Agree No
37197 Remove intrvas foreign body New 6.72 6.29 Disagree No 37211 Thrombolytic art therapy New 8.00 8.00 Agree No
37212 Thrombolytic venous therapy New 7.06 7.06 Agree No
37213 Thromblytic art/ven therapy New 5.00 5.00 Agree No
37214 Cessj therapy cath removal New 3.04 2.74 Disagree No505
In CY 2011, CPT codes 35475 and 35476 were identified in the CMS High Expenditure Procedure Codes Screen. After clinical review of CPT code 35475 (Transluminal balloon angioplasty, percutaneous; brachiocephalic trunk or branches, each vessel), we be lieve a work RVU of 5.75 appropriately captures the work of the service. To deve lop a recommended value for this service, the AMA RUC started with the work RVU of CPT code 37224 (Revascularization, endova scular, open or percutan eous, femoral, popliteal artery(s), unilateral; with transluminal angioplasty ) (work RVU of 9.00), whic h the AMA RUC believed was a comperable service to CPT code 35475, then re moved RVUs to account for overlap in work resulting from same day billing with CPT codes 36147 (Introduction of needle and/or catheter, arteriovenous shunt created for dialysis (graft/fistula); initial access wi th complete radiological eval uation of dialysis access, including fluoroscopy, image document ation and report (include s access of shunt, injec tion[s] of contrast, and all necessary imaging from the arterial anastomosi s and adjacent artery thr ough entire venous outflow including the inferior or superior vena cava)) a nd 75962 (Transluminal balloon angioplasty, peripheral artery other than renal, or other visceral artery, iliac or lower extremity, radiological supervision and interpretation). Using these calc ulations, the AMA RUC recommended a work RVU of 6.60 for CPT code 35475. We agree with this approach, but believe th at CPT code 37220 (Revascularization, endovascular, open or percutaneous, iliac ar tery, unilateral, initial vessel; with tr ansluminal angioplasty) (work RVU 8.15) is more similar to CPT code 35475 and therefore a be tter starting point for the reductions. After acc ounting for overlap with other services typically reported with CPT code 35475, we determined that a work RVU of 5.75 is appropriate for this service. Accordingly, we are assigning a work RVU of 5.75 to CPT code 35475 on an interim final basis for CY 2 013. After clinical review of CPT code 35476 (Transluminal balloon angioplasty, percutaneous; venous), we believe a work RVU of 4.71 more appropriately captures the work of the service. The AMA RUC reviewed the surv ey results and recommended a work RVU of 5.50, the survey 25 th percentile value. We determined that the work associated with CPT code 35476 was similar in terms of physician time and intensity to CPT code 37191 (Insertion of506 intravascular vena cava filter, endovascular appr oach including vascular access, vessel selection, and radiological supervision and interpreta tion, intraprocedural roadmapping, and imaging guidance (ultrasound and fluoroscopy), when pe rformed), which has a wo rk RVU of 4.71. We believe the work RVU of 4.71 appropriately captures the relative difference between this service and CPT code 35475. Therefore, we are as signing a work RVU of 4.71 for CPT code 35476 on an interim final basis for CY 2013. CPT codes 36221 through32668 were identified as potentially misvalued through the Codes Reported Together 75 percent or More screen. For CY 2012, the AMA RUC requested that CPT Editorial Panel create eight new codes to bundle selective catheter placement with radiological supervision and interpretation, including angiography. Additionally, the specialty society recognized that non-invasive vascular imaging has replaced di agnostic angiography as a screening test. After clinical review of CPT code 36221(Non-sel ective catheter placement, thoracic aorta, with angiography of the extracranial carotid, vertebral, and/ or intracranial vessels, unilateral or bilateral, and all associated radiological supervision and interpre tation, includes angiography of the cervicocerebral arch, when performed), we believe a work RVU of 4. 17 more appropriately captures the work of the service, with refinement of 30 minutes to the post -service time. The AMA RUC reviewed the survey results, and after a comparison to similar CPT codes, recommended a value of 4.51 work RVUs and a post-service time of 40 minutes. The AMA RUC used a direct crosswalk to the two component codes being bundled, CPT code 32600 (Introduction of cathe ter, aorta) (work RVU = 3.02) and CPT code 75650 (Angiography, cerviocerebral, catheter, includi ng vessel origin, radiological supervision and interpretation) (work RVU=1.49) and the recommended value of 4.51 is the sum of the RVUs for these component codes. We believe that that there ar e efficiencies gained when services are bundled. We believe crosswalking to the work RVU of CPT c ode 32550 (Insertion of indw elling tunneled pleural catheter with cuff), which has a work RVU of 4.17, appropriately accounts fo r the physician time and intensity with CPT code 36221. A dditionally, we believe that the survey post-service time of 30 minutes more accurately accounts for the time involved in furnishing this service than the AMA RUC-507
recommended post-service time of 40 minutes. Therefore, we are assigning a work RVU of 4.17 with refinement to time for CPT code 36221 on an interim final basis for CY 2013. A complete listing of the times associated with this code is available on the CMS website at www.cms.gov/PhysicianFeeSched /

. After clinical review of CPT code 36222 ((Non- selective catheter placement, thoracic aorta, with angiography of the extracranial carotid, vertebral, and/ or intracranial vessels, unilateral or bilateral, and all associated radiological supervision and interpre tation, includes angiography of the cervicocerebral arch, when performed).), we believe the survey 25 th percentile work RVU of 5.53 appropriately captures the work of this service, particularly the efficien cies when two services are bundled together. The AMA RUC recommended the survey median work RVU of 6.00 . Like CPT code 36221, we believe the survey post-service time of 30 minutes is more appropriate than the AMA RUC-recommended post-service time of 40 minutes. We are assigning a work RVU of 5. 53 with refinement to time for CPT code 36222 as interim final for CY 2013. A complete listing of the times associated with this code is available on the CMS website at: www.cms.gov/PhysicianFeeSched/. After clinical review of CPT code 36223(Selective catheter placement, common carotid or innominate artery, unilateral, any approach, with a ngiography of the ipsilateral intracranial carotid circulation and all associated radiological supervisio n and interpretation, includes angiography of the extracranial carotid and cervicocerebral arch, when pe rformed), we believe a work RVU value of 6.00, the survey 25 th percentile value, appropriately captures the work of the service, particularly efficiencies when two services are bundled together. The AM A RUC reviewed the survey results, and after a comparison to similar CPT codes, recommended a work RVU of 6.50. Like many of the other CPT codes in this family, we believe the survey post-service ti me of 30 minutes is more appropriate than the AMA RUC-recommended time of 40 minutes. We are assigning a work RVU of 6.00 with refinement to time for CPT code 36223 as interim final for CY 2013. A co mplete listing of the times associated with this code is available on the CMS website at: www.cms.gov/PhysicianFeeSched/. After clinical review of CPT co de 36224(Selective catheter placement, in ternal carotid artery, unilateral, with angiography of the ipsilateral intracrani al carotid circulation and all associated radiological supervision and interpretation, incl udes angiography of the extracranial carotid and cervicocerebral arch,508
when performed), we believe a work RVU of 6.50, the survey 25 th percentile value, appropriately captures the work of the serv ice, particular ly efficiencies when two services are bundled together. We believe 30 minutes of post-service times more appropriately accounts for the work of this service. The AMA RUC reviewed the survey results, and after a comparison to similar CPT codes, recommended a value of 7.55 and a post-service time of 40 minutes for CPPT code 36224. Accordingly, we are assigning a work RVU of 6.50 with refinement to time for CPT code 36224 as interim final for CY 2013. A complete listing of the times associated with this code is available on the CMS website at: www.cms.gov/PhysicianFeeSched/. After clinical review of CPT co de 36225 (Selective cath eter placement, subcla vian or innominate artery, unilateral, with a ngiography of the ipsilatera l vertebral circulation and all associated radiological supervision and interpretation, incl udes angiography of the cervicocer ebral arch, when performed), we believe that this code should be valued the same as the CPT code 36223, to which we are assigning a work RVU of 6.00. Comparable to CPT code 36223, we also believe 30 minutes of post-service times more appropriately accounts for the wo rk of this service. The AMA RUC reviewed the survey results and recommended the survey median work RVU of 6.50 and a post-service time of 40 minutes for CPT code 36225. We are assigning a work RVU of 6.00 with refinement to time for CPT code 36225 as interim final for CY 2013. A complete listing of the times as sociated with this code is available on the CMS website at: www.cms.gov/PhysicianFeeSched/. After clinical review of CPT co de 36226 (Selective cathet er placement, vertebra l artery, unilateral, with angiography of the ipsilateral vertebral circulation and all associ ated radiological supervision and interpretation, includes angi ography of the cervicocerebral arch, when performed), we believe that this CPT code should be valued the same as CPT code 36224, which has a work RVU as 6.50. Comparable to CPT code 36224, we also believe 30 minutes of post-service times more appropriately ac counts for the work of this service. The AMA RUC reviewed the survey r esults, and after a comparison to similar CPT codes, recommended a value of 7.55 and a post-service time of 40 minutes for CPT code 36226. We are assigning a work RVU of 6.50 with refinement to time for CPT code 36226 as interim final for CY 2013.509

After clinical review of CPT co de 36227 (Selective cath eter placement, extern al carotid artery, unilateral, with angiography of the ipsilateral external carotid circulation and al l associated radiological supervision and interpretation (list separately in add ition to code for primary procedure)), we determined that there are efficiencies gained when services are bundled, and identified a work RVU of 2.09 for this service. This work RVU reflects the application of a very conservative estimate of 10 percent for the work efficiencies that we would expect to occur wh en multiple component codes are bundled together to the sum of the work RVUs for the component codes. The AMA RUC reviewed the survey results, and after a comparison to similar CPT codes, recommende d a value of 2.32 for CPT code 36227. The AMA RUC used a direct crosswalk to the two compone nt codes being bundled, CPT code 36218 (Selective catheter placement, arterial system; additional sec ond order, third order, and beyond, thoracic or brachiocephalic branch, within a vascular family (list in addition to code for initial second or third order vessel as appropriate) (work RVU= 1.01) and CPT code 75660 (Angiograp hy, external carotid, unilateral, selective, radiological supervision and interpretati on) (work RVU = 1.31). We are assigning a work RVU of 2.09 as the interim final value of CPT code 36227 for CY 2013. (13) Hemic and Lymphatic System: General TABLE 44: Hemic and Lymphatic System: General

HCPCS

Code Short Descriptor CY 2012 Work RVU AMA RUC/HCPAC Recommended

Work RVU CY 2013 Interim/Interim Final Work RVU Agree/Disagree with AMA RUC/HCPAC Recommended

Work RVU CMS Refinement to AMA/HCPAC Recommended Time 38240 Transplt allo hct/donor 2.24 4.00 3.00 Disagree No 38241 Transplt autol hct/donor 2.24 3.00 3.00 Agree No 38242 Transplt allo lymphocytes 1.71 2.11 2.11 Agree No
38243 Transplj hematopoietic boost New 2.13 2.13 Agree No
CPT codes 38240, 38241, 38242, and 38243 were revised by the CPT Editorial Panel for
CY 2013. After clinical review, we agree with th e AMA RUC-recommended work RVUs for CPT codes 38241 (Hematopoietic progenitor cell (hpc); autologous tr ansplantation), 38242510 (Allogeneic lymphocyte infusions), and 38243 (Hem atopoietic progenitor cell (hpc); hpc boost). On an interim final basis for CY 2013 we are assigning a work RVU of 3.00 to CPT code 38241; a work RVU of 2.11 to CPT code 38242; and a work RVU of 2.13 to CPT code 38243. After clinical review, we believe CPT c ode 38240 should have the same work RVU as CPT code 38241, because we believe the two servi ces involve the same amount of work. The AMA RUC recommended a work RVU of 4.00 for CPT code 38240. On an interim final basis for CY 2013 we are assigning CPT code 38240 a work RVU of 3.00. (14) Digestive System: Intestines (Except Rectum) TABLE 45: Digestive System: Intestines (Except Rectum)

HCPCS

Code Short Descriptor CY 2012 Work RVU AMA RUC/HCPAC Recommended

Work RVU CY 2013 Interim/Interim

Final Work RVU Agree/Disagree with AMA RUC/HCPAC Recommended

Work RVU CMS Refinement to AMA/HCPAC Recommended Time 44705 Prepare fecal microbiot a New 1.42 Invalid N/A N/A
G0455 Fecal microbiota prep instill New N/A 0.97 N/A N/A

The CPT Editorial Panel created CPT code 44705 (Preparation of fecal microbiota for instillation, including assessm ent of donor specimen) for CY 2013. The AMA RUC recommended a work RVU of 1.42, which is a di rect crosswalk to CPT code 99203 (Level 3 office or other outpatient visit, new patient). This service is currently (CY 2012) reported under CPT code 44799 (Unlisted procedure, intestine), as is the instillation of th e microbiota. Within Medicare, payment for the preparation of the donor specimen would only be made if the specimen is ultimately used for the treatment of a beneficiary as Medicare is not authorized to pay for any costs not directly related to the diag nosis and treatment of a beneficiary. Because of this policy, we believe it is appr opriate to bundle the pr eparation and instillation into one payable HCPCS code. For CY 2013, we have created HC PCS code G0455 (Preparation with instillation of fecal microbiota by any method, including a ssessment of donor specimen). HCPCS code511 G0455 will replace new CPT code 44705 (Preparati on of fecal microbiota for instillation, including assessment of donor specimen) which w ill have a PFS procedure status indicator of I (Not valid for Medicare purposes), and includes both the work of preparation and instillation of the microbiota. After reviewing the preparation and instillation work associated with this procedure, we believe that CPT code 99213 (Level 3 office or other outpatient visi t, established patient) is an appropriate crosswalk for the work and time of HCPCS code G0455. Ther efore, on an interim final basis for CY 2013, we are assigning a work RVU of 0.97 to HCPCS code G0455. A list of the interim final times associated with this procedure is available on the CMS website at www.cms.gov/physicianfeesched/

. (15) Digestive System: Biliary Tract TABLE 46: Digestive System: Biliary Tract

HCPCS

Code Short Descriptor CY 2012 Work RVU AMA RUC/HCPAC Recommended

Work RVU CY 2013 Interim/Interim

Final Work RVU Agree/Disagree with AMA RUC/HCPAC Recommended

Work RVU CMS Refinement to AMA/HCPAC Recommended Time
47562 Laparoscopic cholecystectomy 11.76 11.76 10.47 Disagree Yes
47563 Laparo cholecystectomy/graph 11.47 11.47 11.47 Agree No 47600 Removal of gallbladder 17.48 20.00 17.48 Disagree No 47605 Removal of gallbladder 15.98 21.00 18.48 Disagree No
In CY 2011, we received comments regarding a potential relativity problem between CPT codes 47600 (Cholecystectomy;) and 47605 (Chol ecystectomy; with cholangiography), as CPT code 47600 has a higher work RVU and more post-operative visits than CPT code 47605. In the CY 2012 PFS proposed rule, we requested that the AMA RUC review these two CPT codes and thanked commenters for bringing this to our attention (76 FR 42796). Currently (CY 2012), CPT code 47600 has a work RVU of 17. 48, and CPT code 47605 has a work RVU of 15.98, which is clearly an anomalous relationship. For CY 2013, the related specialty societies512 resurveyed these two CPT codes. After revi ew, we believe that the work RVU of 17.48 appropriately reflects the work of CPT code 47600, and that the work RVU of CPT code 47605 should be increased to reflect th e increase in work related to the addition of cholangiography. After clinical review, we agree with the AMA RU C and specialty societies that a work RVU of 1.00 is the correct difference between CPT code 47600 and 47605. Therefore, we believe a work RVU of 18.48 accurately accounts for the work associated with CPT code 47605. We do not believe that the work of CPT code 47600 has increased over time. The AMA RUC recommended a work RVU of 20.00 for CPT code 47600 and a work RVU of 21.00 for CPT code 47605. Both values are the specialty societ y survey median work RVUs. On an interim final basis for CY 2013, we are assigning a work RVU of 17.48 to CPT code 47600 and a work RVU of 18.48 to CPT code 47605. In their review of these CPT codes, the specialty societies indicated and the AMA RUC agreed that the typical patient undergoing an open cholecystectomy is scheduled and started with a laparoscopic approach and is th en converted to the open procedur e. We are concerned that the vignettes associated with these procedures im ply that the work of the failed laparoscopic approach is included in the work of the cholecy stectomy. We request that the AMA RUC review the vignettes for these services. CPT codes 47562 and 47563 were identified as potentially misvalued through the High Expenditure Procedure Code screen. Though these service were id entified by CMS as potentially misvalued, the related specialty societies declined to surv ey CPT codes 47562 (Laparoscopy, surgical; cholecystectomy) and 47563 (Laparoscopy, surgica l; cholecystectomy with cholangiography), because, they said, the codes had been resu rveyed many times, with CPT code 47563 last surveyed and reviewed as recently as the F ourth Five-Year Review (CY 2011). The AMA RUC513 Relativity Assessment Workgroup concluded that th ese services have not changed since last reviewed and that resurveying the codes woul d not produce different values. The AMA RUC reaffirmed the current (CY 2012) work RVU of 11.76 for CPT code 47562 and the current (CY 2012) work RVU of 11.47 for CPT code 47563. After clinical review, we noticed a rank-order anomaly in these services similar to the rank-order problem discussed above for CPT codes 47600 and 47605. CPT code 47563, which includes cholangiography, is currently (CY 2012) valued lower than CPT code 47562 which describes the same procedure without cholangiog raphy. After reviewing these two services, we agree with the AMA RUC that the recently-reviewed current work RVU of 11.47 for CPT code 47563 continues to accurately reflect the work of this service. As discussed above, we believe that a work RVU of 1.00 reflects the increm ental difference between cholecystectomy with cholangiography and cholecystectomy alone. Ther efore, we believe that CPT code 47562 should be valued 1.00 RVU lower than CPT code 47563. On an interim final basis for CY 2013, we are assigning a work RVU of 10.47 to CPT code 47562 and a work RVU of 11.47 to CPT code
47563. Regarding physician time, we changed the pre-service time of CPT code 47562 to match the pre-service time of CPT code 47563, leading to small increase in pre-service time for the service. A complete listing of the interim final times assigned to these services is available on the CMS website at www.cms.gov/physicianfeesched/

. (16) Urinary System: Bladder TABLE 47: Urinary System: Bladder

HCPCS

Code Short Descriptor CY 2012 Work RVU AMA RUC/HCPAC Recommended

Work RVU CY 2013 Interim/Interim

Final Work RVU Agree/Disagree with AMA RUC/HCPAC Recommended

Work RVU CMS Refinement to AMA/HCPAC Recommended Time 52214 Cystoscopy and treatment 3.70 3.50 3.50 Agree No 52224 Cystoscopy and treatment 3.14 4.05 4.05 Agree Yes514

52234 Cystoscopy and treatment 4.62 4.62 4.62 Agree No 52235 Cystoscopy and treatment 5.44 5.44 5.44 Agree No 52240 Cystoscopy and treatment 9.71 8.75 7.50 Disagree No
52287 Cystoscopy chemodenervation New 3.20 3.20 Agree No
52351 Cystouretero & or pyeloscope 5.85 5.75 5.75 Agree No
52352 Cystouretero w/stone remove 6.87 6.75 6.75 Agree No 52353 Cystouretero w/lithotripsy 7.96 7.88 7.50 Disagree No 52354 Cystouretero w/biopsy 7.33 8.58 8.00 Disagree No
52355 Cystouretero w/excise tumor 8.81 10.00 9.00 Disagree No
CPT code 52235 was identified as potentiall y misvalued under the Harvard-valued— Utilization over 30,000 screen. CPT codes 52234, 52240, and 52351 through 52355 were identified as a part of this family for review. After clinical review, we agreed with the AMA RUC-recommended work RVUs for the majority of codes in this family. However, we disagreed with th e AMA RUC-recommended work RVUs for CPT codes 52353 (Cystourethros copy, with ureteroscopy and/or pyeloscopy; with lithotripsy (ureteral catheterization is included)), 52354 (Cystourethroscopy, with ureteroscopy and/or pyeloscopy; with biopsy and/or fulguration of ureteral or renal pelvic lesion), 52355 (Cystourethrosc opy, with ureteroscopy and/or pye loscopy; with resection of ureteral or renal pelvic tu mor), and 52240 (Cystourethroscopy, with fulguration (including cryosurgery or laser surgery) and/or resection of; large bla dder tumor(s)). For CPT codes, 52353, 52354, and 52355, we believe that the survey 25 th percentile work RVUs represent a more appropriate incremental differe nce over the base code, CPT code 52351 (Cystourethroscopy, with ureteroscopy and/or pyeloscopy; diagnostic), to which we are assigning an interim final work RVU of 5.75, than the AMA RUC recommended work RVUs of 7.88, 8.58, 10.00, respectively. Additionally, we believe the survey 25 th percentile work RVUs more appropriately account for th e significant reduction in intra- service time of these three CPT codes. Therefore, on an interim final basis for CY 2013, we are assigning a work RVU of 7.50515
for CPT 52353; a work RVU of 8.00 for CPT code 52354; and a work RVU of 9.00 for CPT code 52355. After reviewing CPT code 52240, we believe th is service should be valued the same as CPT code 52353, as the services have the same ti mes and describe very similar procedures. Therefore, on an interim final basis for CY 2013, we are assigning a work RVU of 7.50 to CPT code 52240. Regarding physician time, we refined the AMA RUC-recommended pre-service time for CPT code 52224 (Cystourethroscopy, with fulgurat ion (including cryosurgery or laser surgery) or treatment of minor (less than 0.5 cm) lesion(s) with or without biopsy) from 32 minutes to 29 minutes to match the pre-service time of CP T code 52214 (Cystourethroscopy, with fulguration (including cryosurgery or laser su rgery) of trigone, bladder neck, prostatic fossa, urethra, or periurethral glands) which has very similar pre-service work. A complete list of the interim final times associated with th ese procedures is available on the CMS website at www.cms.gov/physicianfeesched/. (17) Nervous System: Extracranial Nerves, Pe ripheral Nerves, and Autonomic Nervous System TABLE 48: Nervous System: Extracranial Nerves, Peripheral Nerves, and Autonomic Nervous System

HCPCS

Code Short Descriptor CY 2012 Work RVU AMA RUC/HCPAC Recommended

Work RVU CY 2013 Interim/Interim

Final Work RVU Agree/Disagree with AMA RUC/HCPAC Recommended

Work RVU CMS Refinement to AMA/HCPAC Recommended Time 64450 N block other peripheral 1.27 0.75 0.75 Agree No 64612 Destroy nerve face musc le 2.01 1.41 1. 41 Interim No
64613 Destroy nerve neck muscle 2.01 N/A 2.01 Interim N/A
64614 Destroy nerve extrem musc 2.20 N/A 2.20 Interim N/A
64615 Chemodenerv musc migraine New 1.85 1.85 Interim No
64640 Injection treatment of nerve 2.81 1.23 1.23 Agree No

The CPT Editorial Panel created CPT code 64615 and revised CPT codes 64612, 64613,516

and 64614 for CY 2013. When the AMA RUC and related specia lty societies reviewed CPT codes 64613 (Chemodenervation of muscle(s); neck muscle (s) (eg, for spasmodic torticollis, spasmodic dysphonia)) and 64614 (Chemodenervation of muscle (s); extremity and/or trunk muscle(s) (eg, for dystonia, cerebral palsy, multiple sclerosis)), they determined that both CPT codes should be divided into additional codes, and referred CPT codes 64613 and 64614 to the CPT Editorial Panel. The AMA RUC recommended the surv ey median work RVU of 1.41 for CPT code 64612 (Chemodenervation of muscle(s); muscle(s) in nervated by facial nerve, unilateral (eg, for blepharospasm, hemifacial spasm)), a decr ease from the current work RVU of 2.01, and recommended the survey median work RVU of 1.85 for new CPT code 64615 (Chemodenervation of muscle(s); muscle(s) innerv ated by facial, trigeminal, cervical spinal andaccessory nerves, bilateral (eg, for chronic migraine)). We are accepting the AMA RUCrecommended work RVUs for CPT codes 64612 a nd 64615 on an interim basis, and will review these services alongside CPT codes 64613 and 64614 (o r their successor CPT codes) after they are reviewed by the CPT Editorial Panel. The AMA RUC requested a change in the global period of CPT code 64615 from 10 days to 0 days. We believe that a gl obal period of 10 days is most a ppropriate for this service, and maintains consistency within this family of CPT c odes, as the other services in this family also have 10-day global periods. (18) Eye and Ocular Adnexa: Eyeball TABLE 49: Eye and Ocular Adnexa: Eyeball

HCPCS Code Short Descriptor CY 2012 Work RVU AMA RUC/HCPAC Recommended Work RVU CY 2013 Interim/Interim Final Work RVU Agree/Disagree with AMA RUC/HCPAC Recommended Work RVU CMS Refinement to AMA/HCPAC Recommended Time
65222 Remove foreign body from eye 0.93 0.93 0.84 Disagree Yes517

CPT code 65222 was identified as potentiall y misvalued under the Harvard-valued--- Utilization over 30,000 screen. Medicare claims data from 2011 indicat e that CPT code 65222 (Removal of foreign body, external eye; corneal, with slit lamp) is t ypically furnished to the beneficiary on the same day as an E/M visit. We believe that some of the activities furnished during the pre- and postservice period of the procedure code and the E/M visit overlap. After review, we do not believe that the AMA RUC appropriately accounted for this overlap in its recommendation of pre- and post- service time. To account for this overl ap, we reduced the AMA RUC-recommended preservice evaluation time by one-third, from 7 minutes to 5 minutes, and the AMA RUCrecommended post-service time by one-third, from 5 minutes to 3 minutes. We believe that 5 minutes of pre-service evaluation time and 3 minut es of post-service time accurately reflect the time involved in furnishing the pre- and post-service work of this procedure, and that these times are well-aligned with similar services. B ecause we reduced the AMA RUC-recommended procedure time for this code by 4 minutes, at a standard work inte nsity of .0224 RVUs per minute, we believe that it is also appropriate to remove 0.09 RVUs from the current/AMA RUCrecommended RVU of 0.93. In sum, on an inte rim final basis for CY 2013, we are assigning a work RVU of 0.84 to CPT code 65222, with a refi nement to the AMA RUC recommended time. A complete list of the interim final times associat ed with this procedure is available on the CMS website at www.cms.gov/physicianfeesched/. (19) Eye and Ocular Adnexa: Ocular Adnexa518
TABLE 50: Eye and Ocular Adnexa: Ocular Adnexa

HCPCS

Code Short Descriptor CY 2012 Work RVU AMA RUC/HCPAC Recommended

Work RVU CY 2013 Interim/Interim

Final Work RVU Agree/Disagree with AMA RUC/HCPAC Recommended

Work RVU CMS Refinement to AMA/HCPAC Recommended Time
67810 Biopsy eyelid & lid margin 1.48 1.18 1.18 Agree Yes
CPT code 67810 was identified as potentiall y misvalued under the Harvard-valued--- Utilization over 30,000 screen. Medicare claims data from 2011 indicat e that CPT code 67810 (Incisional biopsy of eyelid skin including lid margin) is typically furnished to the beneficiary on the same day as an E/M visit. We believe that some of the activ ities furnished during the pre- and post-service period of the procedure code and the E/M visit ov erlap. After review, we believe that the AMA RUC appropriately accounted for th is overlap in its recommendation of pre-service time, but that the AMA RUC-recommended post-service time, while reduced from the survey time, is still high relative to similar services perf ormed on the same day as an E/M service. To better account forthis overlap, and to value this service relative to similar services, we reduced the AMA RUCrecommended post-service time for this procedur e by one-third, from 5 mi nutes to 3 minutes. After reviewing CPT code 67810 and assessing the overlap in time and work, we agree with the AMA RUC-recommended work RVU of 1.18 for this service, which is a decrease from the CY 2012 work RVU of 1.48. In sum, on an in terim final basis for CY 2013, we are assigning a work RVU of 1.18 to CPT code 67810, with a refinement to the AMA RUC recommended time. A complete list of the interim final times associated with this procedure is available on the CMS website at www.cms.gov/physicianfeesched/

. (20) Eye and Ocular Adnexa: Conjunctiva TABLE 51: Eye and Ocular Adnexa: Conjunctiva519

HCPCS

Code Short Descriptor CY 2012 Work RVU AMA RUC/HCPAC Recommended

Work RVU CY 2013 Interim/Interim

Final Work RVU Agree/Disagree with AMA RUC/HCPAC Recommended

Work RVU CMS Refinement to AMA/HCPAC Recommended Time 68200 Treat eyelid by injection 0.49 0.49 0.49 Agree Yes
CPT code 68200 was identified as potentiall y misvalued under the Harvard-valued--- Utilization over 30,000 screen. Medicare claims data from 2011 indi cate that CPT code 68200 (Subconjunctival injection) is typically furnished to the beneficiar y on the same day as an E/M visit. We believe that some of the activities furnished during th e pre- and post-service period of the procedure code and the E/M visit overlap. After review , we believe that the AMA RUC appropriately accounted for this overlap in its recommendation of pre-service time, but that the AMA RUC did not adequately account for the overl ap in the post-service time. To better account for the overlap in post-service time, we reduced the AMA RU C-recommended post-service time for this procedure by one-third, from 5 minutes to 3 minutes. After reviewing CPT code 68200 and assessing the overlap in time and work, we agree with the AMA RUC-recommended wo rk RVU of 0.49 for this service. In sum, on an interim final basis for CY 2013, we are assigning a work RVU of 0.49 to CPT code 68200, with a refinement to the AMA RUC recommended time. A complete list of the interim final times associated with this procedure is available on the CMS website at www.cms.gov/physicianfeesched/. (21) Auditory System: External Ear TABLE 52: Auditory System: External Ear

HCPCS

Code Short Descriptor CY 2012 Work RVU AMA RUC/HCPAC Recommended

Work RVU CY 2013 Interim/Interim

Final Work RVU Agree/Disagree with AMA RUC/HCPAC Recommended

Work RVU CMS Refinement to AMA/HCPAC Recommended Time 69200 Clear outer ear canal 0.77 0.77 0.77 Agree Yes520

CPT code 69200 was identified as potentiall y misvalued under the Harvard-valued--- Utilization over 30,000 screen. Medicare claims data from 2011 indicat e that CPT code 69200 (Removal foreign body from external auditory canal; without general anes thesia) is typically furnished to the beneficiary on the same day as an E/M visit. We believe that some of the activities furnished during the preand post-service period of the procedure code an d the E/M visit overlap. To account for this overlap, we removed one-third of the pre-service evaluation time from the pre-service time package, reducing the pre-service evaluation time from 7 minutes to 5 minutes. Additionally, we reduced the AMA RUC-recommended post-service ti me for this procedure by one-third, from 5 minutes to 3 minutes. After reviewing CPT code 69200 and assessing the overlap in time and work, we agree with the AMA RUC-recommended wo rk RVU of 0.77 for this service. In sum, on an interim final basis for CY 2013, we are assigning a work RVU of 0.77 to CPT code 69200, with a refinement to the AMA RUC recommended time. A complete list of the interim final times associated with this procedure is available on the CMS website at www.cms.gov/physicianfeesched/. (22) Diagnostic Radiol ogy (Diagnostic Imaging)521
TABLE 53: Diagnostic Radi ology (Diagnostic Imaging)

HCPCS

Code Short Descriptor CY 2012 Work RVU AMA RUC/HCPAC Recommended

Work RVU CY 2013 Interim/Interim

Final Work RVU Agree/Disagree with AMA RUC/HCPAC Recommended

Work RVU CMS Refinement to AMA/HCPAC Recommended Time
72040 X-ray exam neck spine 3/<vws 0.22 0.22 0.22 Agree No
72050 X-ray exam neck spine 4/5vws 0.31 0.31 0.31 Agree No
72052 X-ray exam neck spine 6/>vws 0.36 0.36 0.36 Agree No
72191 Ct angiograph pelv w/o&w/dye 1.81 N/A 1.81 Interim N/A
73221 Mri joint upr extrem w/o dye 1.35 1.35 1.35 Agree No
73721 Mri jnt of lwr extre w/o dye 1.35 1.35 1.35 Agree No 74170 Ct abdomen w/o & w/dye 1.40 1.40 1.40 Agree No
74174 Ct angio abd&pelv w/o&w/dye 2.20 2.20 2.20 Interim No
74175 Ct angio abdom w/o & w/dye 1.90 N/A 1.90 Interim N/A 74247 Contrst x-ray uppr gi tract 0.69 0.69 0.69 Agree No
74280 Contrast x-ray exam of colon 0.99 0.99 0.99 Agree No 74400 Contrst x-ray urinary tract 0.49 0.49 0.49 Agree No

75896 X-rays transcath therapy 1.31 (PC), Contractor Priced (TC) Contractor Priced 1.31 (PC), Contractor Priced (TC) Interim N/A

75898 Follow-up angiography 1.65 (PC), Contractor Priced (TC) Contractor Priced 1.65 (PC), Contractor Priced (TC) Interim N/A

CPT codes 74175 and 72191 were identified as potentially misvalued through the Codes Reported Together 75 percent or More screen. The CPT Editorial Panel created CPT code 74174, which bundles the work of CPT codes 74175 and 72191, for CY 2012. We reviewed CPT code 74174 (Computed tomographic angiography, abdomen and pelvis, with contrast material(s), includi ng noncontrast images, if performed, and image postprocessing) for CY 2012. We stated in the CY 2012 PFS final rule with comment period that we are accepting the AMA RUC-recomm ended work RVU of 2.20 for CPT code 74174 on an interim basis, and reques t that the AMA RUC review the component CPT codes: 74175 (Computed tomographic angiography, abdomen, with contrast material(s), including noncontrast522 images, if performed, and image postpro cessing) and 72191 (Computed tomographic angiography, pelvis, with contrast material(s), including noncontrast im ages, if performed, and image postprocessing) (76 FR 73200). In response to this request, some commente rs stated that the AMA RUC operates under the premise that the values assi gned to all the service paid under the PFS are assumed to be accurate and therefore, our request to review the physician work component of CPT codes 74175 and 72191 is unnecessary. Commenters noted that CPT codes 74175 and 72191 were used as important building blocks in the work valu ation of CPT code 74174, and that the AMA RUC considered their individual values, which in many ways equates to an AMA RUC review. Commenters stated that to review individual c odes solely because they are bundled to create a new code, risks rank-order anomalies within familie s, which could threaten the relativity of the values for services on the PFS. Therefore, co mmenters stated that they believe an AMA RUC review of CPT codes 74175 and 72191 is unnecessary. The AMA RUC Relativity Assessment Wor kgroup referred com ponent CPT codes 74175 and 72191 to the PE Subcommittee of the AMA RU C to review the direct practice expense inputs, but the AMA RUC did not review the physician work or time. We have stated many times our belief that when codes are bundle d, the new codes should be reviewed along with their component codes to ensure consistency in RVUs and inputs. Therefore, we reviewed CPT codes 74174, 72191, and 74175 for CY 2013. During this review, we saw an anomalous relationship between the phys ician times assigned to these services. CPT code 74174 describes computed tomographic angiography (CTA) of both the abdomen and pelvis together. This CPT code includes 5 mi nutes of pre-service tim e, 30 minutes of intraservice time, and 5 minutes of post-service time, which is in line with several other similar bundled CPT codes. CPT code 74175 describes CTA of the abdomen only, and includes 10523 minutes of pre-service time, 30 minutes of intr a-service time, and 10 minutes of post-service time. Similarly, CPT code 72191 describes CTA of the pelvis only, and includes 9 minutes of pre-service time, 30 minutes of intra-service time, and 10 minute s of post-service time. We do not believe that CTA of just the abdomen or ju st the pelvis should include more pre- and postservice time than the combined code. Also, while we believe furnishing the bundled code does not involve much more time than furnishing the stand-alone codes, we find it unlikely that the bundled service requires exactly the same intra- service time as the component services. We request recommendations from th e AMA RUC and other pubic commenters on the appropriate work and time values for these services. We are maintaining the current (CY 2012) work RVUs and times for CPT codes 74174, 72191, and 74175 on an interim basis for CY 2013, and anticipate re-reviewing these services for CY 2014 considering any recommendations that we receive. CPT code 75896 was identified as potentia lly misvalued through the Codes Reported Together 75 percent or More screen. The associated specialty soci eties and the AMA RUC intend to survey and review CPT code 75896 (Transcatheter therapy, infusion, ot her than for thrombolysis, radiological supervision and interpretatio n) and related CPT code 75898 (Angiography through existing catheter for follow-up study for tr anscatheter therapy, embolizati on or infusion, other than for thrombolysis) for CY 2014. The AMA RUC recomme nded carrier pricing these two services for CY 2014. Currently (CY 2012) both codes have a national payment rate for the professional component of the service, and th e technical component of the service is contractor priced. We believe it is appropriate to maintain the curren t national price on the pr ofessional component, and to contractor price the technica l component until we are able to establish a national price that appropriately values the practice expenses associated with this service. Therefore, on an interim524 basis for CY 2013, we are assigning a work RVU of 1.31 to the professional component of CPT code 75896, and a work RVU of 1.65 to the pr ofessional component of CPT code 75898. The technical component and global billing for both CPT codes will be contractor priced. We anticipate reviewing these services again af ter reviewing the AMA RUC recommendations for these services in CY 2014. (23) Diagnostic Ultrasound: Pelvis TABLE 54: Diagnostic Ultrasound: Pelvis

HCPCS

Code Short Descriptor CY 2012 Work RVU AMA RUC/HCPAC Recommended

Work RVU CY 2013 Interim/Interim

Final Work RVU Agree/Disagree with AMA RUC/HCPAC Recommended

Work RVU CMS Refinement to AMA/HCPAC Recommended Time 76830 Transvaginal us non-ob 0.69 0.69 0.69 Agree Yes
CPT code 76830 was identified as potentiall y misvalued through the High Expenditure Procedure Code screen. We reviewed CPT code 76830 (Ultrasound, transv aginal) and believe that the current work RVU of 0.69 continues to accu rately reflect the work of this services. The AMA RUC also recommended maintaining the current work RVU of this service. We are refining the AMA RUC-recommended post-service time for this procedure from 10 minutes to 8 minutes to match the post-service time of CPT code 76817 (Ultras ound, pregnant uterus, real time with image documentation, transvaginal), which, we believe, involves very similar post-service work. In sum, on an interim final basis for CY 2013, we are assigning a work RVU of 0.69 to CPT code 76830, with a refinement to the AMA RUC recomme nded time. A complete list of the interim final times associated with this proce dure is available on the CMS website at www.cms.gov/physicianfeesched/

. (24) Radiologic Guidance: Fluoroscopic Guidance TABLE 55: Radiologic Guidan ce: Fluoroscopic Guidance525

HCPCS

Code Short Descriptor CY 2012 Work RVU AMA RUC/HCPAC Recommended

Work RVU CY 2013 Interim/Interim

Final Work RVU Agree/Disagree with AMA RUC/HCPAC Recommended

Work RVU CMS Refinement to AMA/HCPAC Recommended Time
77001 Fluoroguide for vein device 0.38 N/A 0.38 Interim N/A
77002 Needle localization by xray 0.54 N/A 0.54 Interim N/A
77003 Fluoroguide for spine inject 0.60 0.60 0.60 Interim No
CPT code 77003 was identified as potentiall y misvalued through the High Expenditure Procedure Code screen. We reviewed CPT code 77003 (Fluoroscopic guidance and localization of needle or catheter tip for spine or paraspinous diagnostic or therapeutic injection pr ocedures (epidural or subarachnoid)), and believe it is necessary to review this se rvice alongside very similar CPT codes 77001 (Fluoroscopic guidance for central venous access device placement, replacement (catheter only or complete), or removal (incl udes fluoroscopic guidance for vascular access and catheter manipulation, any necessary contrast in jections through access site or catheter with related venography radiologic su pervision and interpretation, a nd radiographic documentation of final catheter position) (list separately in a ddition to code for primary procedure)) and 77002 (Fluoroscopic guidance for needle placement (eg, biopsy, aspiration, injection, localization device)) to determine the appropriate relative value for this high volume, high expenditure procedure code. The AMA RUC reviewed CPT code 77003 for CY 2013 and concluded that the current work RVU of 0.60 is appropriate for this service. It is our understanding that the AMA RUC does not intend to review CPT codes 77001 and 77002. We anticipate reviewing CPT codes 77001, 77002, and 77003 together in CY 2013 for CY 2014 and request public comments on the appropriate work and time values for these services. On an interim basis for CY 2013, we are maintaining the current work RVU of 0.60 for CPT code 77003. (25) Radiation Oncology: Medi cal Radiation Physics, Dosi metry, Treatment Devices, and526 Special Services TABLE 56: Radiation Oncology: Medical Radiation Physics, Dosimetry, Treatment Devices, and Special Services

HCPCS

Code Short Descriptor CY 2012 Work RVU AMA RUC/HCPAC Recommended

Work RVU CY 2013 Interim/Interim

Final Work RVU Agree/Disagree with AMA RUC/HCPAC Recommended

Work RVU CMS Refinement to AMA/HCPAC Recommended Time
77301 Radiotherapy dose plan imrt 7.99 7.99 7.99 Agree Yes
CPT code 77301 was identified as potentiall y misvalued through the High Expenditure Procedure Code screen. We reviewed CPT code 77301 (Intensity m odulated radiotherapy plan, including dosevolume histograms for target and critical struct ure partial tolerance sp ecifications) and do not believe the work associated with this pr ocedure has changed. The AMA RUC also recommended the current work RVU of 7.99 for this service. On an interim final basis for CY 2013 we are assigning a work RVU of 7.99 to CP T code 77301. Regarding the physician time for this service, CPT code 77301 currently (CY 2012) includes 30 minutes of pre-service time, 131 minutes of intra-service time, and 35 mi nutes of post-service time. The AMA RUC recommended moving the pre-service time associated with this procedure into the intra-service period. We do not believe this is appropriate, as we think the physician work associated with those 30 minutes is pre-service work and should re main in the pre-service period. Therefore, we are assigning an interim final pre-service evalua tion time of 30 minutes, intra-service time of 130 minutes, and post-service time of 35 minutes to CPT code 77301 for CY 2013. (26) Molecular Pathology TABLE 57: Molecular Pathology

HCPCS

Code Short Descriptor CY 2012 Work RVU AMA RUC/HCPAC Recommended

Work RVU CY 2013 Interim/Interim

Final Work RVU Agree/Disagree with AMA RUC/HCPAC Recommended

Work RVU CMS Refinement to AMA/HCPAC Recommended Time527

G0452 Molecular pathology interpr New N/A 0.37 N/A N/A

The AMA CPT Editorial Panel has created new CPT codes to replace the codes used to bill for molecular pathology services that will be deleted at the end of CY 2012. The new codes describe distinct molecular path ology tests and test methods. The CPT Editorial Panel created 101 new molecular pathology CPT codes for CY 2012 and another 14 new molecular pathology codes for CY 2013. As discussed in detail in section III.I. of this CY 2013 PFS final rule with comment period, these new molecular pathology CPT codes will be paid on the CLFS for CY
2013. One of the molecular pathology CPT codes that is being deleted for CY 2012 is payable on the PFS: CPT code 83912-26 (Molecular diagnostics; interpretation and re port). To replace this CPT code, we have created HCPCS code G0452 (molecular pathology procedure; physician interpretation and report) to de scribe medically necessary interp retation and written report of a molecular pathology test, above a nd beyond the report of laboratory results. This professional component-only HCPCS G-code will be considered a “clinical laboratory interpretation service,” which is one of the current categories of PFS pathology services under the definition of physician pathology services at §415.130(b)(4). Section §415.130(b )(4) of the regulations and section 60 of the Claims Processing Manual (I OM 100-04, Ch. 12, section 60.E.) specify certain requirements for billing the professional compon ent of certain clinical laboratory services including that the interpretation (1) must be requested by the patient’ s attending physician, (2) must result in a written narrativ e report included in the patient’ s medical record, and (3) requires the exercise of medical judgment by the consulta nt physician. We note th at a hospital’s standing order policy can be used as a substitute for the individual request by a patient’s attending physician. The current CPT code for interpretation and report, 83912-26, is included on the528 current list of clinical laboratory interpretation services but will be de leted at the end of CY
2012. As discussed in section III.I. of this CY 2013 PFS final rule with comment period, we reviewed the work associated with this procedur e, and we believe it is appropriate to directly crosswalk the work RVUs and times of CPT code 83912-26 to HCPCS code G0452, because we do not believe this coding change reflects a change in the service or in the resources involved in furnishing the service. Accordingly, we are assigning a work RVU of 0.37, with 5 minutes of pre-service time, 10 minutes of intra-service time, and 5 minutes of post-service time to HCPCS code G0452 on an interim final basis for CY 2013. (27) Immunology TABLE 58: Immunology

HCPCS

Code Short Descriptor CY 2012 Work RVU AMA RUC/HCPAC Recommended

Work RVU CY 2013 Interim/Interim

Final Work RVU Agree/Disagree with AMA RUC/HCPAC Recommended

Work RVU CMS Refinement to AMA/HCPAC Recommended Time
86153 Cell enumeration phys interp New 0.69 0.69 Agree Yes

The CPT Editorial Panel created CPT c odes 86152 and 86153 to replace CPT Category III codes 0279T and 0280T. CPT code 86153 (Cell enumeration using im munologic selection a nd identification in fluid specimen (eg, circulating tumor cells in bl ood); physician interpreta tion and report, when required) will be payable on the PFS for the phys ician interpretation a nd report of CPT code 86152 (Cell enumeration using immunologic selecti on and identification in fluid specimen (eg, circulating tumor cells in blood )) which will be payable on the Clinical Laboratory Fee Schedule (CLFS). Like HCPCS code G0452 discusse d above, CPT code 86153 is a professional component-only CPT code that will be considered a “clinical laboratory interpretation service,”529 which is one of the current categories of PFS pathology services under the definition of physician pathology services at §415.130( b)(4). This code must be billed with the “26” modifier to be paid under the PFS. After reviewing CPT code 86153, we believe that the AMA RUC-recommended work RVU of 0.69 appropriately accounts for the work of this service. Accordingly, we are assigning a work RVU of 0.69 to CPT code 86153 on an interim final basis for CY 2013. Regarding physician time, the AMA RUC recommended 20 minut es of intra-service time and 5 minutes of post-service time for CPT code 86153. We believe th at all the work of th is service belongs in the intra-service period, and that 20 minutes accu rately captures the time involved in furnishing this service. Therefore, we are assigning 0 minutes pre-service time, 20 minutes intra-service time, and 0 minutes post-service time to CPT c ode 86153 on an interim final basis for CY 2013. (28) Cytopathology and Surgical Pathology TABLE 59: Cytopathology and Surgical Pathology

HCPCS

Code Short Descriptor CY 2012 Work RVU AMA RUC/HCPAC Recommended

Work RVU CY 2013 Interim/Interim

Final Work RVU Agree/Disagree with AMA RUC/HCPAC Recommended

Work RVU CMS Refinement to AMA/HCPAC Recommended Time
88120 Cytp urne 3-5 probes ea spec 1.20 1.20 1.20 Interim No
88121 Cytp urine 3-5 probes cmptr 1.00 1.00 1.00 Interim No 88312 Special stains group 1 0.54 0.54 0.54 Agree No 88365 Insitu hybridization (fish) 1.20 N/A 1.20 Interim N/A 88367 Insitu hybridization auto 1.30 N/A 1.30 Interim N/A
88368 Insitu hybridization manual 1.40 N/A 1.40 Interim N/A
88375 Optical endomicroscpy interp New Contractor Priced Contractor Priced N/A N/A G0416 Sat biopsy 10-20 3.09 N/A 3.09 N/A N/A

The CPT Editorial Panel created CPT code s 88120 (Cytopathology, in situ hybridization (eg, FISH), urinary tract specimen with morphom etric analysis, 3-5 molecular probes, each specimen; manual) and 88121 (Cyt opathology, in situ hybridizati on (eg, FISH), urinary tract530 specimen with morphometric analysis, 3-5 mol ecular probes, each spec imen; using computerassisted technology) to describe in situ hybridi zation testing using urine samples, effective for CY 2011. Prior to CY 2011, all in situ hybridization testing wa s billed using CPT codes 88365 (In situ hybridization (eg, FI SH), each probe), 88367 (Morph ometric analysis, in situ hybridization (quantitative or semi-quantit ative) each probe; using computer-assisted technology), and 88368 (Morphometric analysis, in situ hybridization (qua ntitative or semiquantitative) each probe; manual). The appropriate code would be billed one time for each probe used in the performance of the test, regardle ss of the medium of the specimen (that is, blood, tissue, tumor, bone marrow, or urine). We stat ed in the CY 2012 PFS proposed rule that because the descriptors for the new CPT codes 88120 an d 88121 include the use of approximately 4 probes, and existing CPT codes 88367 and 88368 in clude only 1 probe, we were concerned about potential payment discrepancies betw een the new and existing codes (76 FR 42795 through 42796). Unlike the new codes for urinary tract specimens, the ex isting codes (for all other specimens) allow for multiple units of each code to be billed. We asked the AMA RUC to review the work and PE for existing CPT codes 88365, 88367, and 88368 alongside CPT codes 88120 and 88121 to ensure the appropriate relativity between these two sets of services (76 FR 73153 through 73154). In response to that request, the College of American Pathologists (CAP) indicated that they would develop a CPT Assist ant article clarifying the appropriate usage of each code. The AMA RUC stated that it intends to review these services in CY 2013 for CY 2014, after CY 2012 utilization data are available to assess how these services are being billed. We agree with this approach, and are mainta ining the current (CY 2012) work RVUs of 1.20 for CPT code 88120, and 1.00 for CPT code 88121, as interim until we review CPT codes 88120 and 88121 alongside CPT codes 88365, 88367, and 88368 for CY 2014.531

We have received information from stakeh olders that the current (CY 2012) descriptor for HCPCS code G0416 (Surgical pathology, gross and microscopi c examination for prostate needle saturation biopsy sampling, 1-20 specimens ) should be revised to better reflect the interaction of this service, and associated R VUs, with billing for su rgical pathology. After reviewing the service, we agree with stakeholders. For CY 2013, we are revising the descriptor for HCPCS code G0416 to the following: Su rgical pathology, gross and microscopic examination for prostate needle saturation biopsy sampling, 10-20 specimens. HCPCS code G0416 will be interim final, and ope n for public comment for CY 2013. (29) Psychiatry TABLE 60: Psychiatry

HCPCS

Code Short Descriptor CY 2012 Work RVU AMA RUC/HCPAC Recommended

Work RVU CY 2013 Interim/Interim

Final Work RVU Agree/Disagree with AMA RUC/HCPAC Recommended

Work RVU CMS Refinement to AMA/HCPAC Recommended Time 90785 Psytx complex interactive New Contractor Priced 0.11 Interim N/A
90791 Psych diagnostic evaluation New 3.00 2.80 Interim No
90792 Psych diag eval w/med srvcs New 3.25 2.96 Interim No
90832 Psytx pt&/family 30 minutes New 1.50 1.25 Interim No
90833 Psytx pt&/fam w/e&m 30 min New 1.50 0.98 Interim No
90834 Psytx pt&/family 45 minutes New 2.00 1.89 Interim No
90836 Psytx pt&/fam w/e&m 45 min New 1.90 1.60 Interim No
90837 Psytx pt&/family 60 minutes New 3.00 2.83 Interim No
90838 Psytx pt&/fam w/e&m 60 min New 2.50 2.56 Interim No 90839 Psytx crisis initial 60 min New Contractor Priced Contractor Priced N/A N/A 90840 Psytx crisis ea addl 30 min New Contractor Priced Contractor Priced N/A N/A 90845 Psychoanalysis 1.79 2.10 1.79 Interim Yes 90846 Family psytx w/o patient 1.83 2.40 1.83 Interim Yes 90847 Family psytx w/patient 2.21 2.50 2.21 Interim Yes 90853 Group psychotherapy 0.59 0.59 0.59 Interim Yes
90863 Pharmacologic mgmt w/psytx New Contractor Priced Invalid N/A N/A532

In preparation for the Fourth Five-Year Review of Work, we received comments indicating that psychiatry/psychotherapy CPT codes 90801 through 90880 may be potentially misvalued. In response to these comments, we requested that the AMA RUC review these services. Ultimately, the AMA RUC conc luded that the entire section of psychiatry/psychotherapy services would benefit from re-structuring within CPT. After a year of analysis, the CPT Editorial Panel replaced the cu rrent psychiatry/psychotherapy CPT codes with a new structure that allows for th e separate reporting of E/M codes, eliminates the site-of-service differential, establishes CPT codes for crisis, and creates a series of add-on CPT codes to psychotherapy to describe interactive complexity and medication management. We appreciate all the work that has been completed to date by the CPT Editorial Panel, AMA RUC, and involved specialty societies in re vising this family of CPT codes. Below we discuss the specific CY 2013 work RVUs for the new psychotherapy family of CPT codes. We note that related specialty societies have not ye t surveyed some of the new CPT codes, namely, the new CPT codes for psychotherapy for crisis , interactive complexity, and pharmacologic management. The AMA RUC and HCPAC have recommended contractor pricing for these services until the surveys are complete. After th e specialty societies have completed the survey process for all the codes in the ne w code set, we intend to review the values for all codes in the family again. It is our policy to value a fam ily of codes together to ensure more accurate valuation and proper relativity. We will take into consideration the AMA RUC and HCPAC recommendations, specialty society recommenda tions, public comments, Medicare utilization data, and other available information. For CY 2013, our general approach was to maintain the current CPT code values, or adopt values that approximate the values for the current CPT codes after adjusting for differences in code stru cture between CY 2012 and 2013, for all psychiatry533 services on an interim basis, pend ing a final review of the values for the entire family of CPT codes. The first major change in the new coding fr amework involves changes to the CPT codes for initial psychiatric evaluati on. For CY 2013, the CPT Editorial Panel is deleting CPT codes 90801 (Psychiatric diagnostic interview examin ation) (work RVU = 2.80 ) and 90802 (Interactive psychiatric diagnostic interview examination usi ng play equipment, physical devices, language interpreter, or other mechanisms of communi cation) (work RVU = 3.01), and replacing them with new CPT codes 90791 (Psychiatric diagno stic evaluation) a nd 90792 (Psychiatric diagnostic evaluation with medical service). CPT code 90791 describes psychiatric diagnostic evaluation without medical wor k. We are assigning an inte rim work RVU of 2.80, the work RVU of deleted CPT code 90801, to this service for CY 2013. CPT code 90792 describes psychiatric diagnostic evaluation involving medical work. We ar e assigning an interim work RVU of 2.96 to this service for CY 2013. Cu rrently (CY 2012) the psychotherapy with E/M services are valued on average 0.16 work RVUs higher than the psychotherapy without E/M services. We believe this is the appropriate differe ntial between the diagnostic evaluation with medical services and diagnostic evaluation without medical services CPT codes. Therefore, to assign a work RVU to CPT code 90792, which includes medical services, we added 0.16 work RVUs to the work RVU of CPT code 90791, wh ich does not include medical services. Regarding coding and payment for these CP T codes, we note that CPT prefatory language for these new psychiatric diagnosis codes allows for reporting of these codes more than once when an informant is “seen in lieu of th e patient.” Medicare only pays for services provided to diagnose or treat a Medicare beneficiary. Obtaining information from relatives or close associates is appropriate in some circumstances, but should not substitute entirely for an evaluation of the patient.534 We previously have addressed the delivery of mental health services to caregivers in Chapter 1, section 70.1 of the Medicare Nationa l Coverage Determinations Manual, Pub. 100-03, which provides guidance specifically for current CPT code 90846 (family psychotherapy without the patient present). It states that, “In certain types of medi cal conditions, including when a patient is withdrawn and uncommunicative due to a mental disorder or comatose, the physician may contact relatives and close associates to secure background inform ation to assist in diagnosis and treatment planning. When a physic ian contacts their patient’s relatives or associates for this purpose, expe nses of such interviews are properly chargeable as physician’s services to the patient on whose behalf the in formation was secured. A physician may also have contacts with a patient’s family and associ ates for purposes other than securing background information. In some cases, the physician will pr ovide counseling to members of the household. Family counseling services are covered only wher e the primary purpose of such counseling is the treatment of the patient’s condition. For exam ple, two situations where family counseling services would be appropriate are as follows: (1) where there is a need to observe the patient’s interaction with family members; and/or (2) wher e there is a need to assess the capability of and assist the family members in aiding in the mana gement of the patient. Counseling principally concerned with the effects of the patient’s c ondition on the individual being interviewed would not be reimbursable as part of the physician’s pe rsonal services to the patient.” Therefore, we believe that CPT codes 90791 and 90792 may be used for diagnosis through a relative or close associate providing direct care for the patient when the focus of the service is gathering additional information about the beneficiary, an d cannot substitute for an evaluation of the beneficiary. We are concerned that multiple di agnostic evaluations with family members should not replace a detailed evaluation of the benefici ary, and we intend to monitor the frequency of billing for diagnostic evaluations per patient.535 The second major change in the new coding framework involves psychotherapy procedure codes without medical services, which we typically expect will be billed by clinical psychologists and licensed clini cal social workers. For CY 2013, the CPT Editorial Panel created stand-alone psychotherapy CPT codes 90832 (Psychotherapy, 30 minutes with patient and/or family member), 90834 (Psychotherapy, 45 mi nutes with patient and/or family member), and 90837 (Psychotherapy, 60 minutes with patient a nd/or family member), that are not site-ofservice specific. These servic es are currently reported us ing outpatient a nd interactive outpatient, and inpatient and inte ractive inpatient psychotherapy CP T codes. To assign interim work RVUs to these services that approximate the current values for these services under the current CPT coding structure, we assigned each new stand-alone psychotherapy CPT code the work RVU of the current corresponding inpatient psychotherapy code. Specifically, we are assigning an interim work RVU of 1.25 to CPT code 90832, which is the current work RVU of CPT code 90816 (Individual psychotherapy, insight oriented, behavior modifying and/or supportive, in an inpatient hospital, partial hospi tal or residential care setting, approximately 20 to 30 minutes face-to-face with the patient;); an interim work RVU of 1.89 to CPT code 90834, which is the current work RVU of CPT code 90818 (Individual psychother apy, insight oriented, behavior modifying and/or supportive, in an inpatie nt hospital, partial hosp ital or residential care setting, approximately 45 to 50 minutes face-to-f ace with the patient;); and an interim work RVU of 2.83 to CPT code 90837, which is the current work RVU of CPT code 90821 (Individual psychotherapy, insight oriented, behavior modifyi ng and/or supportive, in an inpatient hospital, partial hospi tal or residential care setti ng, approximately 75 to 80 minutes face-to-face with the pa tient;). For CY 2013, the additional work involved in psychotherapy with higher interactive complexity will be captured using an interactive complexity add-on CPT code, discussed below.536 Regarding coding and payment for these psycho therapy CPT codes, we note that the CY 2012 CPT codes describe time spent face-to-face w ith the patient, while the CY 2013 CPT codes describe time spent with the pa tient and/or family member. As discussed above in relation to CPT codes 90791 and 90792, Medicare only pays for services provided to diagnose or treat a Medicare beneficiary. Obtaining information from relatives or close associates is appropriate in some circumstances, but should not substitute for direct treatment of the beneficiary. We would expect psychotherapy to be billed only when the beneficiary is present fo r a significant portion of the service. The third major change in the new coding framework involves psychotherapy services furnish alongside an E/M service. For CY 2013, the CPT Editorial Panel created CPT codes 90833 (Psychotherapy, 30 minutes with patient and/ or family member when performed with an evaluation and management service (list separa tely in addition to the code for primary procedure)), 90836 (Psychothera py, 45 minutes with patient and/or family member when performed with an evaluation and management servic e (list separately in addition to the code for primary procedure)) and 90838 (Psychotherapy, 60 mi nutes with patient and/or family member when performed with an evaluati on and management service (list separately in addition to the code for primary procedure)). These servic es are currently reporte d using outpatient and interactive outpatient, and inpatient and inte ractive inpatient psychotherapy with E/M CPT codes. For CY 2013, physicians and qualified n onphysician practitioners that can bill for E/M services will now bill for psychotherapy with ev aluation and management using the existing E/M structure and a choice of one add-on psychothe rapy time-based code, 30, 45 or 60 minutes. At this time, we believe that the work involved in furnishing the psychotherapy add-on CPT codes is very similar to the work of furnishing the stand-alone psychotherapy CPT codes (CPT codes 90832, 90834, and 90837). We believe the difference in work between the psychotherapy add-537 on codes and stand-alone psychotherapy CPT codes is not in the intensity of the services; rather, it is in amount of time involved in furnishing them. The AMA RUC has recommended, and we agree, that the psychotherapy ad d-on CPT codes include 12 minutes less time than the standalone psychotherapy CPT codes. The psychot herapy add-on CPT codes are furnished alongside an E/M service, so some of th e activities in the st and-alone psychotherapy CPT codes should not be included in the psychotherapy add-on CPT codes because those activities (reviewing the record, coordinating care, and some documentation and reporting activities) are included in the E/M service with which the add-on codes will be billed. Accordingly, to assign interim work RVUs to each of the new psychotherapy add-on CP T codes, we started with the interim work RVU of the corresponding new stand-alone psyc hotherapy CPT code, and then reduced that RVU by 0.27 RVUs, to capture the 12 minutes less tim e assigned to these serv ices (12 minutes at an intensity of 0.0224 RVUs per minute= 0.27 RVUs). Specifically, we are assigning an interim work RVU of 0.98 to CPT code 90833; an inte rim work RVU of 1.60 for CPT code 90836; and an interim work RVU of 2.56 for CPT code 90838. Like the stand-alone psychotherapy serv ices, we note that the CY 2012 CPT codes describe time spent face-to-face with the pati ent, while the CY 2013 CPT codes describe time spent with the patient and/or family member. As discussed above, Medicare only pays for services provided to diagnose or treat a Medi care beneficiary. Obtaining information from relatives or close associates is appropriate in some circumstances, but should not substitute for direct treatment of the benefici ary. We would expect psychother apy to be billed only when the beneficiary is present for a signi ficant portion of the service. Additionally, the CY 2013 coding structure includes a new add-on CPT code for interactive complexity, CPT code 90785 (Interactive complexity (list separately in addition to the code for primary procedure)). The interactive complexity add-on CPT code, when billed with a538 psychotherapy service, replaces the CY 2012 CPT codes for interactive psychotherapy. As stated above, this service has not yet been surveyed by the relate d specialty societies, and the AMA RUC recommended contractor pricing this service for CY 2013. However, given that services involving interactive complexity are na tionally priced in the CY 2012 coding structure, we believe we have enough information to a ssign interim work RVUs for CPT code 90785 for CY 2013. In the 2012 coding structure, there are CPT codes for outpatient and inpatient psychotherapy services and corr esponding CPT codes for outpatien t and inpatient interactive psychotherapy services. For both th e outpatient and inpatient services, the interactive service has a work RVU that is 0.11 RVUs highe r than the correspondi ng service that is not interactive. We believe this reflects the current value of interac tive services. Therefore, we are assigning an interim work RVU of 0.11 to CPT code 90785 fo r CY 2013. We are assigning this service 0 minutes of physician time because the work RVU of 0.11 reflects only the incremental difference in intensity of the base procedure; the time of this service is captured in the time of the procedure with which it is billed. Regarding coding and payment for CPT code 90785, the CPT prefatory language for this service states that psychiatric procedures may be reported with interactive complexity for “...Use of play equipment, other physical devices, interpreter or translator to communicate with the patient to overcome barriers to therapeutic or diagnostic intera ction between the physician or other qualified health care professi onal and a patient who is not fluent in the same language as the physician or other qualified he alth care professional, or has not developed, or has lost, either the expressive language communication skills to explain his/her symptoms and response to treatment, or the receptive co mmunication skills to understand the physician or other qualified health care professional if he/she were to use typical language for communication.” Given this language, we would like to clarify that CPT code 90785 generally should not be billed solely for539 the purpose of translation or inte rpretation services. Federal la ws prohibit discrimination, which in this case would take the form of higher bene ficiary payments and copayments for the same service, based on disability or ethnicity. Billi ng for this service solely for translation or interpretation related to a beneficiary’s di sability could implicate section 504 of the Rehabilitation Act of 1973 and the Am ericans with Disabilities Act, and billing for this service solely for translation or interpretation related to foreign language could im plicate Title VI of the Civil Rights Act of 1964. The CPT Editorial Panel has created two new CPT codes for psychotherapy when a patient is in crisis, CPT codes 90839 (Psyc hotherapy for crisis; first 60 minutes) and 90840 (Psychotherapy for crisis; each additional 30 minutes (list separately in addition to code for primary service)). As these CPT codes ha ve not yet been surveyed, the AMA RUC has recommended contractor pricing for CPT codes 90839 and 90840 for CY 2013. We agree and are assigning CPT codes 90839 and 90840 a PFS proce dure status of C (C ontractors price the code. Contractors establish RVUs and payment amounts for these services on an interim basis for CY 2013. Additionally, for CY 2013, the CPT Edito rial Panel has deleted CPT code 90862 (Pharmacologic management, including prescripti on, use, and review of medication with no more than minimal medical psychotherapy). For CY 2013, psychiatri sts will now bill the appropriate E/M code when furnishing pharmacol ogic management services. The CPT Editorial Panel also created CPT add-on code 90863 (Pharm acologic management, including prescription and review of medication, when performed with psychotherapy se rvices (list separately in addition to the code for primary procedure) to describe medication management by a nonphysician when furnished with psychotherapy. We understand from our past meetings with stakeholders that the ability to prescribe medi cine is predicated upon first providing evaluation540 and management (E/M) services. We have disc ussed in previous rulemaking that Medicare does not recognize clinical psychologists to bill E/M services because they are not authorized to furnish those services under their state scop e of practice (62 FR 59057). While clinical psychologists have been granted prescribing privileges in Loui siana and New Mexico, they are not licensed or authorized under their State sc ope of practice to furnish the full range of traditional E/M services. CPT code 90862 describes pharmacologic management, including prescription, use, and review of medication with no more than minimal medical psychotherapy. This descriptor reference to “medical psychot herapy” implies that th e service furnished under CPT code 90862 is an E/M service, and therefore, clinical psychologists cannot bill Medicare for CPT code 90862. We also believe that clinical psychologists w ould continue to be precluded from billing Medicare for pharmacologic ma nagement services under new CPT code 90863, even in the absence of the reference to “medical psychotherapy” because pharmacologic management services require some knowledge and ability to perform evaluation and management services. Even though clinical ps ychologists in Louisiana and New Mexico have been granted prescribing privileges, clinical psychologists in those a nd other states are not licensed or authorized to furn ish E/M services. Accordingly, on an interim basis for CY 2013, we are assigning CPT code 90863 a PFS procedure stat us indicator of I (Not valid for Medicare purposes. Medicare uses another code for the reporting of and the payment for these services.). We invite public comment on our interi m assignment of this procedure status. Finally, under the new coding structur e, existing psychotherapy CPT codes 90845 (Psychoanalysis), 90846 (Family psychotherapy (without the patient present)), 90847 (Family psychotherapy (conjoint psyc hotherapy) (with patient pr esent)), and 90853 (Group psychotherapy (other than of a multiple-family group)) remain essentially unchanged for CY 2013. We are maintaining the current (CY 2012) wo rk RVUs and times for these services on an541 interim basis for CY 2013. Specifically, we are assigning an interim work RVU of 1.79 for CPT code 90845; an interim work RVU of 1.83 for CP T code 90846; and interim work RVU of 2.21 for CPT code 90847; and an interim work RVU of 0.59 for CPT code 90853. The AMA RUC and HCPAC-recommended RVUs ar e listed in the table at the start of this section. Regarding physician time, we accepted the AMA RUC-recommended times for all the new CPT codes in this family. We are ma intaining the current work RVUs and times for existing CPT codes 90845, 90846, 90847, and 90853 on an interim basis until we are able to review all the recommended values for this fam ily of CPT codes. Re garding the utilization crosswalk, we made some refinements to th e AMA RUC-recommended utilization crosswalks for the new psychotherapy CPT codes, based on our understanding of how th ese services will be billed for CY 2013. We will re-review these as sumptions when we review all recommended values for this family of CPT codes. The CY 2013 physician time file and utilization crosswalk are available on the CMS website at www.cm s.gov/physicianfeesched/. (30) Cardiovascular: Therapeu tic Services and Procedures TABLE 61: Cardiovascular: Therapeutic Services and Procedures

HCPCS

Code Short Descriptor CY 2012 Work RVU AMA RUC/HCPAC Recommended

Work RVU CY 2013 Interim/Interim

Final Work RVU Agree/Disagree with AMA RUC/HCPAC Recommended

Work RVU CMS Refinement to AMA/HCPAC Recommended Time
92920 Prq cardiac angioplast 1 art New 9.00 10.10 Disagree Yes 92921 Prq cardiac angio addl art New 4.00 Bundled N/A N/A
92924 Prq card angio/athrect 1 art New 11.00 11.99 Disagree Yes 92925 Prq card angio/athrect addl New 5.00 Bundled N/A N/A
92928 Prq card stent w/angio 1 vsl New 10.49 11.21 Disagree Yes
92929 Prq card stent w/angio addl New 4.44 Bundled N/A N/A 92933 Prq card stent/ath/angio New 12.32 12.54 Disagree Yes 92934 Prq card stent/ath/angio New 5.50 Bundled N/A N/A 92937 Prq revasc byp graft 1 vsl New 10.49 11.20 Disagree Yes 92938 Prq revasc byp graft addl New 6.00 Bundled N/A N/A 92941 Prq card revasc mi 1 vsl New 12.32 12.56 Disagree No 92943 Prq card revasc chronic New 12.32 12.56 Disagree Yes542

HCPCS

Code Short Descriptor CY 2012 Work RVU AMA RUC/HCPAC Recommended

Work RVU CY 2013 Interim/Interim

Final Work RVU Agree/Disagree with AMA RUC/HCPAC Recommended

Work RVU CMS Refinement to AMA/HCPAC Recommended Time 1vsl
92944 Prq card revasc chronic addl New 6.00 Bundled N/A N/A
CPT code 92980 (Transcatheter placement of an intracoronary stent(s), percutaneous, with or without other therapeu tic intervention, any me thod; single vessel) was identified for review because it is on the MPC list. After reviewing CPT code 92980, the related specialty societies believed that the fam ily of percutaneous coronary in tervention (PCI) codes should be revised to better reflect current practice, and referred the family of codes to the CPT Editorial Panel for review. The CPT Editorial Panel appr oved 13 new PCI CPT codes for CY 2013 to replace the 6 existing codes. In the current (CY 2012) c oding structure, CPT code 92980 describes the placement of a coronary stent in a single vessel, and add-on CPT code 92981 describes placement of a stent in each a dditional vessel. As currently described, a single vessel includes one artery and all its branches. Under this codi ng convention, if a physician placed a stent in one artery and one branch to that artery, the phys ician would bill only CPT code 92980. If that physician placed a stent in one artery and one branch of that artery, then went on to place a stent in a second artery and one branch of that artery, the physician would bill CPT code 92980 along with add-on CPT code 92981. The CY 2013 coding structure creates more codes and more granular coding. For CY 2013, the placement of a stent in an artery is bill ed using a base code, and the placement of a stent in a branch of that artery is billed using an add-on code. Stenting each new artery is billed using a new base code and stenting each branch is billed using an add-on to that base code. If a physician placed a stent in one artery and one bran ch of that artery, and then went on to place a543 stent in a second artery and one branch of that second artery, the physician would bill two base code/add-on pairs. The CPT Panel made similar changes to the current codes for angioplasty and atherectomy and added new codes for ather ectomy with stenting, a ny revascularization of a coronary artery bypass graft, and any revasc ularization procedure through a chronic total occlusion of any coronary artery or graft. The CPT Panel created a separate base code for each procedure for each new artery and an add-on code fo r each branch within that artery. Finally, the CPT Panel created a new code for any revascular ization procedure for an acute coronary artery occlusion during an acute myocardi al infarction. This final code does not have an add-on code. We believe that this revised coding structur e represents a CPT trend toward identifying greater granularity in co des describing the most intense and difficult work. As we discuss in section III.B.1. of this final ru le with comment period, the agency has an interest in pursuing additional bundling in the PFS payment structur e. Bundling is one method for structuring payment that can improve payment accuracy a nd efficiency. We believe that unbundling the placement of branch-level stents in a fee-for-s ervice system may encourage increased placement of stents. To eliminate that incentive, on an interim final basis for CY 2013, we are rebundling the work associated with the placem ent of a stent in an arterial br anch into the base code for the placement of a stent in an artery. Specifically, we are bundling the work of CPT code 92921 (Percutaneous transluminal coronary angioplasty; each additi onal branch of a major coronary artery (list separately in addition to code for primary procedure)) in to CPT code 92920 (Percutaneous transluminal coronary angioplasty; single major coronary artery or branch); we are bundling the work of CPT code 92925 (Percutaneous transluminal coronary atherectomy, with coronary angioplasty when performed; each additional branch of a major corona ry artery (list separately in addition to code544 for primary procedure)) into CPT code 92924 (Per cutaneous transluminal coronary atherectomy, with coronary angioplasty when performed; singl e major coronary artery or branch); we are bundling with work of CPT code 92929 (Percutaneous transcatheter placement of intracoronary stent(s), with coronary angioplasty when perfor med; each additional branch of a major coronary artery (list separately in addition to code for primary procedure)) into CPT code 92928 (Percutaneous transcatheter placement of intracoronary stent(s), with coronary angioplasty when performed; single major coronary artery or br anch); we are bundling the work of CPT code 92934 (Percutaneous transluminal coronary atherect omy, with intracoronary stent, with coronary angioplasty when performed; each additional branch of a major coronary arte ry (list separately in addition to code for primary procedure)) in to CPT code 92933 (Percutaneous transluminal coronary atherectomy, with intr acoronary stent, with coronary angioplasty when performed; single major coronary artery or branch); we are bundling the wo rk of CPT code 92938 (Percutaneous transluminal revascularization of or through coronary artery bypass graft (internal mammary, free arterial, venous), any combinati on of intracoronary st ent, atherectomy and angioplasty, including di stal protection when performed; each additional branch subtended by the bypass graft (list separately in addition to code for primar y procedure)) into CPT code 92937 (Percutaneous transluminal revascularization of or through coronary artery bypass graft (internal mammary, free arterial, venous), any combinati on of intracoronary st ent, atherectomy and angioplasty, including dist al protection when performed; sing le vessel); and we are bundling the work of CPT code 92944 (Percutaneous translum inal revascularization of chronic total occlusion, coronary artery, cor onary artery branch, or coronary artery bypass graft, any combination of intracoronary stent, atherect omy and angioplasty; each additional coronary artery, coronary artery branch, or bypass graft ( list separately in addition to code for primary procedure)) into CPT code 92943 (Percutaneous tr ansluminal revasculariz ation of chronic total545 occlusion, coronary artery, cor onary artery branch, or coronary artery bypass graft, any combination of intracoronary stent, at herectomy and angioplasty; single vessel). To bundle the work of each new add-on code into its respective base code, we used the AMA RUC-recommended utilization crosswalk to determine what pe rcentage of the base code utilization would be billed with the add-on code, and added that percentage of the add-on code AMA RUC-recommended work RVU to the base code AMA RUC-recommended work RVU. For example, the AMA RUC estimated that CPT code 92920 would have 26,848 Medicare allowed services in CY 2013, and that corr esponding add-on CPT code 92921 would have 7,368 Medicare allowed services in CY 2013. Theref ore, the AMA RUC estimates that CPT code 92920 will be billed without add-on CPT code 92921 for 73 percent of the Medicare allowed services, and that CPT code 92920 will be billed with add-on CPT code 92921 for 27 percent of the allowed services (7,368/26,848). To account fo r the additional work involved in 27 percent of the allowed services, we added a work R VU of 1.10 (27.44 percent of a work RVU of 4.00 for CPT code 92921) to the work RVU of 9.00 for CP T code 92920, to get to a work RVU of 10.10 for the combined service. We followed this methodology to establish the combined work RVUs for all the new base code/add-on code pairs. Based this methodology, we are assigning the following interim final work RVUs for CY 2013: a work RVU of 10.10 to CPT code 92920; a work RVU of 11.99 to CPT code 92924; a work RVU of 11.21 to CPT code 92928; a work RVU of 12.54 to CPT code 92933; a work RVU of 11.20 to CPT code 92937; and a work RVU of 12.56 to CPT code 92943. On an interim final basis for CY 2013, add-on CPT codes 92921, 92925, 92929, 92934, 92938, and 92944 will have a PFS pro cedure status indicator of B (Bundled code. Payments for covered services are always bundled into payment for other services, which are not specified. If RVUs are s hown, they are not used for Medicare payment.546 If these services are covered, payment for them is subsumed by the payment for the services to which they are bundled) and will not be separately payable. We did not use this methodology directly to establish a work RVU for CPT code 92941 (Percutaneous transluminal revascularization of acute total/subtotal occlusion during acute myocardial infarction, coronary artery or coronary artery byp ass graft, any combination of intracoronary stent, atherect omy and angioplasty, including aspiration thrombectomy when performed, single vessel), which does not have a specific corresponding add-on code. After reviewing this service al ongside the other services in this family, like the AMA RUC, we believe CPT code 92941 should have the same work RVU as CPT code 92943 to preserve the appropriate rank order of the services in this fa mily. As we stated a bove, we are assigning a work RVU of 12.56 to CPT code 92943. Therefore, on an interim final basis for CY 2013 we are assigning a work RVU of 12.56 to CP T code 92941, with the AMA RUC-recommended intra-service time of 70 minutes. The AMA RUC recommended RVUs for these servic es are listed in the table above. The CY 2013 physician time file and utilization cros swalk are available on the CMS website at www.cms.gov/physicianfeesched /. (31) Cardiovascular: Intracardiac El ectrophysiological Procedures/Studies
TABLE 62: Cardiovascular: Intracardiac Electrophysiological Procedures/Studies

HCPCS

Code Short Descriptor CY 2012 Work RVU AMA RUC/HCPAC Recommended

Work RVU CY 2013 Interim/Interim

Final Work RVU Agree/Disagree with AMA RUC/HCPAC Recommended

Work RVU CMS Refinement to AMA/HCPAC Recommended Time
93653 Ep & ablate supravent arrhyt New 15.00 15.00 Agree No 93654 Ep & ablate ventric tachy New 20.00 20.00 Agree No 93655 Ablate arrhythmia add on New 9.00 7.50 Disagree No 93656 Tx atrial fib pulm vein isol New 20.02 20.02 Agree No 93657 Tx l/r atrial fib addl New 10.00 7.50 Disagree No

CPT codes 93651 and 93652 were identified as potentially misvalued through the Codes547 Reported Together 75 percent or More screen. The CPT Editorial Panel deleted CPT codes 93651 and 93652, and replaced them with ne w CPT codes 93653 through 93657 for CY 2013. We reviewed new CPT codes 93653 (Com prehensive electrophysiologic evaluation including insertion and repositioning of multiple electrode catheters with induction or attempted induction of an arrhythmia with right atrial pacing and record ing, right ventricular pacing and recording, his recording with intracardiac catheter ablati on of arrhythmogenic focus; with treatment of supraventricular tachycardia by abla tion of fast or slow atrioventricular pathway, accessory atrioventricular connection, cavo-tricuspi d isthmus or other single atrial focus or source of atrial re-entry), 93654 (Comprehensive electrophys iologic evaluation including insertion and repositioning of mu ltiple electrode catheters with induction or attempted induction of an arrhythmia with right at rial pacing and recording, right ventricular pacing and recording, his recording with intracardiac catheter ablation of arrhythmogenic focus; with treatment of ventricular tachycardia or focus of ventricu lar ectopy including intracardiac electrophysiologic 3d mapping, when performed, and left ventricula r pacing and recording, when performed), and 93656 (Comprehensive electrophysio logic evaluation including tr ansseptal catheterizations, insertion and repositioning of mu ltiple electrode catheters with induction or attempted induction of an arrhythmia with atrial recording and pacing, when possibl e, right ventricular pacing and recording, his bundle recording with intracardiac cat heter ablation of arrhythmogenic focus, with treatment of atrial fibrillation by ablation by pulmonary vein isol ation). We believe that the survey 25 th percentile work RVUs of 15.00 for CPT code 93653, 20.00 for CPT code 93654, and 20.02 for CPT code 93656 accurately account for the work involved in furnishing these services. The AMA RUC recommended these values as well, with 180 minutes of intra-service time for CPT code 93653, and 240 minutes of intra-serv ice time for CPT codes 93654 and 93656. We agree with these values. Accordingly, we ar e assigning a work RVU of 15.00 for CPT code548
93653, a work RVU of 20.00 for 93654, and a work RVU of 20.02 for CPT code 93656, with no refinements to the AMA RUC-recommended ti me, on an interim final basis for CY 2013. After reviewing CPT codes 93655 (Intracardiac ca theter ablation of a discrete mechanism of arrhythmia which is distinct from the prim ary ablated mechanism, including repeat diagnostic maneuvers, to treat a spontaneous or induced arrhyt hmia (list separately in addition to code for primary procedure)) and 93657 (Additional linear or focal intracardiac cath eter ablation of the left or right atrium for treatme nt of atrial fibrillation remain ing after completion of pulmonary vein isolation (list separately in addition to c ode for primary procedure)), we believe these CPT codes have a very similar level of intensity as their related base codes: CPT codes 93653, 93654,and 93656. CPT codes 93653, 93654, and 93656 are all valued at 5.00 RVUs per 1 hour of intraservice time. We believe th is is the appropriate increm ent for CPT codes 93655 and 93657 as well, which include 90 minutes of intra-service time. Therefore, we believe that a work RVU of 7.50 accurately accounts for the work of these serv ices and reflects the appropriate relativity within this family of CPT codes. The AMA RUC recommended a work RVU of 9.00 for CPT code 93655 and a work RVU of 10.00 for CPT c ode 93657. We are assigning a work RVU of 7.50 to CPT codes 93655 and 93657 with no refinements to the AMA RUC-recommended time, on an interim final basis for CY 2013. (32) Noninvasive Vascular Diagnostic Studies: Extremity Arterial Studies (Including Digits) TABLE 63: Noninvasive Vascular Diagnos tic Studies: Extremity Arterial Studies (Including Digits)

HCPCS

Code Short Descriptor CY 2012 Work RVU AMA RUC/HCPAC Recommended

Work RVU CY 2013 Interim/Interim

Final Work RVU Agree/Disagree with AMA RUC/HCPAC Recommended

Work RVU CMS Refinement to AMA/HCPAC Recommended Time 93925 Lower extremity study 0.58 0.90 0.80 Disagree Yes 93926 Lower extremity study 0.39 0.70 0.50 Disagree Yes 93970 Extremity study 0.68 0.70 0.70 Agree No 93971 Extremity study 0.45 0.45 0.45 Agree No549 CPT codes 93925 and 93926 were identified by the AMA RUC as potentially misvalued because the time and PE inputs for these servic es had never been reviewed by the AMA RUC and these services have utiliz ation of 500,00 service per year. After reviewing CPT codes 93925 (Duplex scan of lower extremity arteries or arterial bypass grafts; complete bilateral study) and 93926 (Duplex scan of lower extremity arteries or arterial bypass grafts; unilateral or limited study), we believe that the specialty society survey
25 th percentile work RVUs of 0.80 for CPT code 93925, and 0.50 for CPT code 93926 accurately account for the work involved in furnishing th ese services and appr opriately captures theincrease in work since these services were last valued. We believe that the AMA RUCrecommended the survey median work RVUs of 0.90 for CPT code 93925 and 0.70 for 93926 overstate the increase in value for these services and that those values are too high relative to similar services. Regarding physician time, we have refined the AMA RUC-recommended preservice and post-service times fr om 5 minutes to 3 minutes to align with similar CPT codes 93922 (Limited bilateral noninvasive physiologic studi es of upper or lower extremity arteries, (eg, for lower extremity: ankle/brachial indice s at distal posterio r tibial and anterior tibial/dorsalis pedis arteries plus bidirectional, doppler waveform recording and analysis at 1-2 levels, or ankle/brachial indices at distal posterior tibial and anteri or tibial/dorsalis pedis arteries plus volume plethysmography at 1-2 levels, or ankle/brachial indices at distal poste rior tibial and anterior tibial/dorsalis pedis arteries with, tr anscutaneous oxygen tension measurement at 1-2 levels)) and 93923 (Complete bila teral noninvasive physiologic studies of upper or lower extremity arteries, 3 or more levels (eg, for lo wer extremity: ankle/brach ial indices at distal posterior tibial and anterior ti bial/dorsalis pedis arteries plus segmental blood pressure measurements with bidirectional doppler waveform recording and analysis, at 3 or more levels, or ankle/brachial i ndices at distal posterior ti bial and anterior tibial/dor salis pedis arteries plus550 segmental volume plethysmography at 3 or more levels, or ankle/brachia l indices at distal posterior tibial and anterior tibi al/dorsalis pedis arteries plus segmental transcutaneous oxygen tension measurements at 3 or more levels), or single level study with provocative functional maneuvers (eg, measurements with postural provo cative tests, or measurements with reactive hyperemia). In sum, we are assigning a work RVU of 0.80 to CPT code 93925 and a work RVU of 0.50 to CPT code 93926, with refinements to the AMA RUC-recommended times, on an interim final basis for CY 2013. A complete list of the interim final times assigned to these procedures is available on the CMS we bsite at www.cms.gov/physicianfeesched/. (33) Neurology and Neuromuscular Pr ocedures: Sleep Medicine Testing TABLE 64: Neurology and Neuromuscula r Procedures: Sleep Medicine Testing

HCPCS

Code Short Descriptor CY 2012 Work RVU AMA RUC/HCPAC Recommended

Work RVU CY 2013 Interim/Interim

Final Work RVU Agree/Disagree with AMA RUC/HCPAC Recommended

Work RVU CMS Refinement to AMA/HCPAC Recommended Time
95782 Polysom <6 yrs 4/> paramtrs New 3.00 2.60 Disagree No 95783 Polysom <6 yrs cpap/bilvl New 3.20 2.83 Disagree No

The CPT Editorial Panel created CPT code s 95782 and 95783 for CY 2013 to describe the physician work involved in pediatric polys omnography for children 5 years of age or
younger. We reviewed CPT codes 95782 and 95783 and de termined that the specialty society survey 25 th percentile work RVUs of 2.60 for CPT code 95782 (Polysomnography; younger than 6 years, sleep staging with 4 or more additiona l parameters of sleep, attended by a technologist) and 2.83 for CPT code 95783 (Polysomnography; younger than 6 years, sleep staging with 4 or more additional parameters of sleep, with in itiation of continuous pos itive airway pressure therapy or bi-level ventilation, attended by a technologist) appropriate ly reflect the work involved in furnishing these services. CP T codes 95782 and 95783 were previously reported551 under CPT codes 95810 (Polysomnography; age 6 years or older, sleep staging with 4 or more additional parameters of sleep, attended by a technologist) and 95811 (Polysomnography; age 6 years or older, sleep staging with 4 or more a dditional parameters of sl eep, with initiation of continuous positive airway pressure therapy or b ilevel ventilation, attended by a technologist). These CPT codes (95810 and 95811) have revise d descriptors for CY 2013 indicating age 6 years and older. CPT code 95810 has a CY 2012 work RVU of 2.50, and CPT code 95811 has a CY 2012 work RVU of 2.60. We be lieve the increase from these cu rrent work RVUs to the CY 2013 work RVUs of 2.60 for CPT code 95782 and 2.83 for CPT code 95783 reflect the incremental difference in work between the existi ng services for ages 6 years and older and new services for younger than 6 years. The AMA RUC recommended the specialty society survey median work RVUs of 3.00 for CPT c ode 95782 and 3.20 for CPT code 95783. We are assigning a work RVU of 2.60 to CPT code 95782 and a work RVU of 2.83 to CPT code 95783 on an interim final basis for CY 2013. (34) Neurology and Neuromuscular Procedures : Electromyography and Nerve Conduction Tests TABLE 65: Neurology and Neuromuscular Procedures: Electromyography and Nerve Conduction Tests

HCPCS

Code Short Descriptor CY 2012 Work RVU AMA RUC/HCPAC Recommended

Work RVU CY 2013 Interim/Interim Final Work RVU Agree/Disagree with AMA RUC/HCPAC Recommended

Work RVU CMS Refinement to AMA/HCPAC Recommended Time 95860 Muscle test one limb 0.96 0.96 0.96 Agree No 95861 Muscle test 2 limbs 1.54 1.54 1.54 Agree No 95863 Muscle test 3 limbs 1.87 1.87 1.87 Agree No 95864 Muscle test 4 limbs 1.99 1.99 1.99 Agree No 95865 Muscle test larynx 1.57 1.57 1.57 Agree No
95866 Muscle test hemidiaphragm 1.25 1.25 1.25 Agree No
95867 Muscle test cran nerv unilat 0.79 0.79 0.79 Agree No
95868 Muscle test cran nerve bilat 1.18 1.18 1.18 Agree No 95869 Muscle test thor paraspinal 0.37 0.37 0.37 Agree No 95870 Muscle test nonparaspinal 0.37 0.37 0.37 Agree No
95885 Musc tst done w/nerv tst lim 0.35 0.35 0.35 Agree No 95886 Musc test done w/n test 0.92 0.92 0.70 Disagree No552

HCPCS

Code Short Descriptor CY 2012 Work RVU AMA RUC/HCPAC Recommended

Work RVU CY 2013 Interim/Interim Final Work RVU Agree/Disagree with AMA RUC/HCPAC Recommended

Work RVU CMS Refinement to AMA/HCPAC Recommended Time comp 95887 Musc tst done w/n tst nonext 0.73 0.73 0.47 Disagree No
95905 Motor &/ sens nrve cndj test 0.05 0.05 0.05 Agree No
95907 Motor&/sens 1-2 nrv cndj tst New 1.00 1.00 Agree No
95908 Motor&/sens 3-4 nrv cndj tst New 1.37 1.25 Disagree Yes
95909 Motor&/sens 5-6 nrv cndj tst New 1.77 1.50 Disagree Yes
95910 Motor&sens 7-8 nrv cndj test New 2.80 2.00 Disagree No
95911 Motor&sen 9-10 nrv cndj test New 3.34 2.50 Disagree No
95912 Motor&sen 11-12 nrv cnd test New 4.00 3.00 Disagree No
95913 Motor&sens 13/> nrv cnd test New 4.20 3.56 Disagree No

CPT codes 95860, 95861, 95863, and 95864 were iden tified as potentially misvalued through the Codes Reported Together 75 percent or More screen. The related specialty societies submitted a code change proposal to the CPT Ed itorial Panel to bundle the services commonly reported together. In response, for CY 2012, th e CPT Panel created three add-on codes (CPT codes 95885 through 95887), and for CY 2013, the Pa nel created seven new codes (CPT codes 95907 through 95913) that bundle the work of mu ltiple nerve conduction studies into each individual code. We first reviewed CPT codes 95885 (Needle electromyography, each extremity, with related paraspinal areas, when performe d, done with nerve conduction, amplitude and latency/velocity study; limited ( list separately in addition to c ode for primary procedure)), 95886 (Needle electromyography, each extremity, with rela ted paraspinal areas, when performed, done with nerve conduction, amplitude an d latency/velocity study; complete, five or more muscles studied, innervated by three or more nerves or f our or more spinal levels (list separately in553 addition to code for primary procedure)), and 95887 (Needle electromyography, non-extremity (cranial nerve supplied or axial) muscle (s) done with nerve conduction, amplitude and latency/velocity study (list separa tely in addition to code for primary procedure)) for the CY 2012 PFS final rule with comment period. We stated that we were accepting the AMA RUCrecommended work RVUs and times on an interim basis, pending review of the other electromyography services (76 FR 73207). For CY 2013 we were able to review these services alongside the related electromyography services and nerve conduction tests. After reviewing these services, we agree with the AMA RUC-recommended times and RVUs for needle electromyography CPT codes 95860 through 95870 (all list ed in the table above). We also agree with the AMA RUC-recommendations for the CY 2012 needle electromyography add-on CPT code 95885, however we do not agree with the AMA RUC recommendations for the other two CY 2012 needle electromyography add-on CPT codes 95886 and 95887. After review, we determined that the AMA RUC-recommended work RVU of 0.35 for CPT code 95885 was appropriate and was we ll-aligned with CPT code 95870 (Needle electromyography; limited study of muscles in 1 extremity or non-limb (axial) muscles (unilateral or bilateral), othe r than thoracic paraspinal, cran ial nerve supplied muscles, or sphincters), to which we are assigning a work RVU of 0.37; the services involve similar work and both include 15 minutes of intra-service time. We believe that CPT codes 95886 and 95887 involve the same level of work intensity as CPT code 95885. To determine the appropriate RVU for CPT codes 95886 and 95887 relativ e to 95885, we increased the work RVU in proportion to the increase in time for the serv ices. Under this methodology, becau se we are assigning a work RVU of 0.35 and 15 minutes of intra-service time to CPT code 95885, we believe it is appropriate to assign a work RVU of 0.70 to CP T code 95886, which has an intra-service time of 30 minutes; and a work RVU of 0.47 to CPT c ode 95887, which has an intra-service time of 20554

minutes. The AMA RUC recommended a work RVU of 0.92 for CPT code 95886 and a work RVU of 0.73 for CPT code 95887. We are assi gning a work RVU of 0.70 to CPT code 95886 and a work RVU of 0.47 to CPT code 95887 on an interim final basis for CY 2013. We reviewed new CPT codes 95907 (Nerve conduction studies; 1-2 studies), 95908 (Nerve conduction studies; 3-4 studies), 95909 (Nerve conduction studies; 5-6 studies), 95910 (Nerve conduction studies; 7-8 studies), 95911 (Nerve conduction studies; 9-10 studies), 95912 (Nerve conduction studies; 11-12 studies), a nd 95913 (Nerve conduction studies; 13 or more studies) and found that the pr ogression of the survey 25 th percentile work RVUs and survey median times appropriately reflect the relativity of these services. The two CPT codes in the nerve conduction studies series that describe the fewest nerve conduction studies, 95907 and 95908, are the exception to this trend, as the survey 25 th percentile work RVUs are too low relative to other fee sc hedule services. For CPT code 95907, the survey 25 th percentile work RVU is 0.48, but we believe that the survey median and AMA RUC recommended work RVU of 1.00 is more appropriate for this service. For CPT code 95908, the survey 25 th percentile work RVU is 1.00, however CPT code 95908 should be valued between CPT code 95907 and 95909, which has a survey 25 th percentile work RVU of 1.50. We believe a wo rk RVU of 1.25, halfway between the work RVU of CPT codes 95907 a nd 95909, accurately reflects the work of this service relative to other services in this se ries. The AMA RUC recommended the survey median values for most of the services in the series , and used a crosswalk methodology to develop a work RVU recommendation for CPT codes 95908 a nd 95909. In sum, on an interim final basis for CY 2013, we are assigning a work RVU of 1.00 to CPT code 95907; a work RVU of 1.25 to CPT code 95908; a work RVU of 1.50 to CPT codes 95909; a work RVU of 2.00 to CPT codes 95910; a work RVU of 2.50 to CPT code 95911; a work RVU of 3.00 to CPT code 95912; and a work RVU of 3.56 to CPT code 95913. We ar e refining the AMA RUC-recommended intra-555

service time for CPT code 95908 from 25 minutes to the survey median time of 22 minutes, and for CPT code 95909 from 35 minutes to the survey median time of 30 minutes, so that all the CPT codes in this series are valu ed using the survey median intra-service time. A complete list of the interim final times assigned to these pr ocedures is available on the CMS website at www.cms.gov/physicianfeesched/. (35) Neurology and Neuromuscular Procedur es: Evoked Potentials and Reflex Tests TABLE 66: Neurology and Neuromuscular Pro cedures: Evoked Potentials and Reflex Tests

HCPCS

Code Short Descriptor CY 2012 Work RVU AMA RUC/HCPAC Recommended

Work RVU CY 2013 Interim/Interim

Final Work RVU Agree/Disagree with AMA RUC/HCPAC Recommended

Work RVU CMS Refinement to AMA/HCPAC Recommended Time 95925 Somatosensory testing 0.54 N/A 0.54 Interim N/A 95926 Somatosensory testing 0.54 N/A 0.54 Interim N/A
95928 C motor evoked uppr limbs 1.50 N/A 1.50 Interim N/A 95929 C motor evoked lwr limbs 1.50 N/A 1.50 Interim N/A 95938 Somatosensory testing 0.86 0.86 0.86 Interim No
95939 C motor evoked upr&lwr limbs 2.25 2.25 2.25 Interim No
CPT code pairs 95925 with 95926, and 95928 with 95929, were identified as potentially misvalued through the Codes Reported Together 75 percent or More screen. For CY 2012, the CPT Editorial Panel created CPT code 95938 to capture the reporting of CPT codes 95925 and 95926 together, and CPT codes 95939 to capture the reporting of CPT codes 95928 with 95929. The related specialty societies surveyed CPT codes 95938 and 95939 and the AMA RUC sent us recommendations on those services for the CY 2012 PFS final rule with comment period. We reviewed CPT codes 95938 (Short-late ncy somatosensory evoked potential study, stimulation of any/all peripheral nerves or skin sites, recording from the central nervous system; in upper and lower limbs) and 95939 (Central moto r evoked potential study (transcranial motor stimulation); in upper and lower limbs) for the CY 2012 PFS final rule with comment period. In that rule, we stated that we were accepti ng the AMA RUC-recommended values on an interim556 basis, and requested that th e AMA RUC review the component CPT codes 95925 (Short-latency somatosensory evoked potential study, stimulation of any/all peripheral ne rves or skin sites, recording from the central nervous system; in upper limbs), 95926 (Short-latency somatosensory evoked potential study, stimulation of any/all periphera l nerves or skin site s, recording from the central nervous system; in lower limbs), 95928 (Central motor evoked potential study (transcranial motor stimulati on); upper limbs), and 95929 (Central motor evoked potential study (transcranial motor stimulation); lower limbs) (76 FR 73207 through 73208). In response to this request, the AMA RUC Relativity Assessment Workgroup referred component CPT codes 95925, 95926, 95928, and 95929 to the PE Subcommittee of the AMA RUC to review the direct practice expense inpu ts, but the AMA RUC decided not to review the physician work or time. When reviewing the physician work and time for the two new bundled CPT codes and their component codes, we saw unlikely relati onships between the physician times assigned to these services, especially CPT codes 95928, 95929, and 95939. Given these time anomalies, we are also concerned the current (CY 2012) work RVUs do not reflect the appr opriate relativity of the services. CPT code 95939 describes an evok ed potential study in both the upper and lower limbs together, and is assigned 30 minutes of in tra-service time. CPT code 95928 describes an evoked potential study in the upper limbs only, and is assigned 60 minutes of intra-service time. CPT code 95929 describes an evoked potential st udy in the lower limbs, and is assigned 55 minutes of intra-service time. We do not beli eve that an evoked poten tial study on the upper or lower limbs alone takes twice as long as an evoked potential study on both the upper and lower limbs. Additionally, CPT code 95938 describes an evok ed potential study in both the upper and lower limbs together, and is assigned 30 minutes of intra- service time. CPT code 95925557 describes an evoked potential study in the upper li mbs only and is assigned 15 minutes of intraservice time. CPT code 95926 describes an evok ed potential study in the lower limbs and is assigned 15 minutes of intra-servi ce time. We note that the intra-service times of CPT codes 95925 and 95926 are significantly different from th e intra-service times of CPT codes 95928 and 95929 for very similar procedures, but somehow the new bundled procedure codes for both have 30 minutes of intra-service time. We conclude that there are valuation and time inaccuracies, both across the evoked potential study codes a nd relative to the new bundled codes. For example, for CPT codes 95925 and 95926, we do not be lieve that the correct intra-service time for CPT code 95938 can be the sum of the intr a-service times of CPT codes 95925 and 95926, as we are confident that there efficiencies to be recognized when perf orming these services together. Given these anomalous relationships, we request public comments on the appropriate work and time values for these services. We are maintaining the current (CY 2012) work RVUs and times for CPT codes 95925, 95926, 95928, 95929, 95938, and 95939 on an interim basis for CY 2013, and anticipate re-reviewing these services for CY 2014. (36) Neurology and Neuromuscular Pro cedures: Intraoperative Neurophysiology

TABLE 67: Neurology and Neuromuscular Pr ocedures: Intraoperative Neurophysiology

HCPCS

Code Short Descriptor CY 2012 Work RVU AMA RUC/HCPAC Recommended

Work RVU CY 2013 Interim/Interim

Final Work RVU Agree/Disagree with AMA RUC/HCPAC Recommended

Work RVU CMS Refinement to AMA/HCPAC Recommended Time
95940 Ionm in operatng room 15 min New 0.60 0.60 Agree No
95941 Ionm remote/>1 pt or per hr New 2.00 Invalid N/A N/A
G0453 Cont intraop neuro monitor New N/A 0.50 N/A N/A
Effective January 1, 2013, the CPT Edito rial Panel is deleting CPT code 95920 (Intraoperative neurophysiology testing, per hour (List separately in addition to code for primary558 procedure)), and is replacing it with CPT codes 95940 (Continuous intraoperative neurophysiology monitoring in the operating ro om, one on one monitoring requiring personal attendance, each 15 minutes) and CPT code 95941 (Continuous intraoperative neurophysiology monitoring, from outside the operating room (remote or nearby) or for monitoring of more than one case while in the operating ro om, per hour). Currently remote monitoring is billed under the PFS using CPT code 95920, though the code does not sp ecify whether the physic ian is present in the same room with a patient or monitoring from a remote location, nor does the code descriptor indicate whether the code may be billed for th e monitoring of one patient or more than one simultaneously. Some carriers have established lo cal coverage determinati ons (LCDs) to address these issues and more tightly define the circumstances under which CPT code 95920 may be billed. The CPT prefatory language for CPT code 95941 states: “... One or more simultaneous cases may be reported...Report 95941 for all remote or non-one on one monitoring time connected to each case regardless of overlap wi th other cases.” Given this language, we are concerned that CPT code 95941 allows a practi tioner to bill individua l beneficiaries for monitoring more than one beneficiary for the sa me work during the same time interval. To resolve this concern, we ha ve created HCPCS code G0453 (Continuous intraoperative neurophysiology monitoring, from outside the operat ing room (remote or nearby), per patient, (attention directed exclusively to one patient) each 15 minutes (list in addition to primary procedure)), effective January 1, 2013. HCPCS code G0453 may be billed only for undivided attention by the monitoring physician to a single beneficiary, not for simultaneous attention by the monitoring physician to more than one patient. HCPCS code G0453 may be billed in multiple units to account for the cumulative time spent monitoring, that is, 15 minutes of continuous attendance followed by another 15 minut es later in the procedure would constitute559 one half hour of monitoring, and CPT code G 0453 would be billed with a unit of 2. HCPCS code G0453 will replace CPT code 95941, which will have a PFS procedure status indicator of I (Not valid for Medicare purposes . Medicare uses another code for the reporting of and the payment for these services) for CY 2013. CPT code 95940, which describes continuous intraoperative neurophysiology monitoring in the ope rating room for one patient at a time, will be payable on the PFS for CY 2013, with a PFS pr ocedure status indica tor of A (Active). After reviewing CPT code 95940, we agree with the AMA RUC that a work RVU of 0.60 accurately accounts for the work involved in furnis hing this procedure. We are assigning a work RVU of 0.60 to CPT code 95940 on an interim fina l basis for CY 2013. Als o, we agree with the AMA RUC that a work RVU of 2.00 accurately accounts for the work for involved in furnishing 60 minutes of continuous intra operative neurophysiology monito ring from outside the operating room. Accordingly, we are assigning a wo rk RVU of 0.50 to HCPCS code G0453, which describes 15 minutes of monitoring from outside the operating room, on an interim final basis for
CY 2013. (37) Physical Medicine and Rehabil itation: Active Wound Care Management TABLE 68: Physical Medicine and Rehab ilitation: Active Wound Care Management

HCPCS

Code Short Descriptor CY 2012 Work RVU AMA RUC/HCPAC Recommended

Work RVU CY 2013 Interim/Interim

Final Work RVU Agree/Disagree with AMA RUC/HCPAC Recommended

Work RVU CMS Refinement to AMA/HCPAC Recommended Time
G0456 Neg pre wound <=50 sq cm New N/A Contractor Priced N/A N/A
G0457 Neg pres wound >50 sq cm New N/A Contractor Priced N/A N/A
For CY 2013, we are creating two HCPCS codes in order to provide a payment mechanism for negative pressure wound therapy services furnished to beneficiaries through means unrelated to the durable medical equi pment benefit: G0456 (Negative pressure wound therapy,(eg vacuum assisted drainage collecti on) using a mechanically-powered device, not560 durable medical equipment, including provisi on of cartridge and dr essing(s), topical application(s), wound assessment, and instructions for ongoing car e, per session; total wound(s) surface area less than or equal to 50 square centimeters) and G0457 (Negative pressure wound therapy,(eg vacuum assisted drainage collecti on) using a mechanically-powered device, not durable medical equipment, including provisi on of cartridge and dr essing(s), topical application(s), wound assessment, and instructions for ongoing care, per session; total wound(s) surface area greater than 50 sq cm). The two new codes will be c ontractor priced on an interim basis for CY 2013. We request comments on th e appropriate value for this service. (38) Inpatient Neonatal Intensiv e Care Services and Pediatri c and Neonatal Critical Care Services: Pediatric Critical Care Patient Transport TABLE 69: Inpatient Neonatal Intensive Ca re Services and Pediatric and Neonatal Critical Care Services: Pediatric Critical Care Patient Transport

HCPCS

Code Short Descriptor CY 2012 Work RVU AMA RUC/HCPAC Recommended

Work RVU CY 2013 Interim/Interim

Final Work RVU Agree/Disagree with AMA RUC/HCPAC Recommended

Work RVU CMS Refinement to AMA/HCPAC Recommended Time
99485 Suprv interfacilty transport New 1.50 Bundled N/A N/A
99486 Suprv interfac trnsport addl New 1.30 Bundled N/A N/A
The CPT editorial panel created CPT code s 99485 and 99486 for CY 2013, to describe the non-face-to-face services provided by physician to supervise interfacility care of critically ill or critically injure d pediatric patients. We reviewed CPT codes 99485 (Supervision by a control physician of interfacility transport care of the critically ill or critica lly injured pediatric patie nt, 24 months of age or younger, includes two-way communication with transpor t team before transport, at the referring facility and during the transpor t, including data interpretation and report; first 30 minutes) and 99486 (Supervision by a control physician of interfacili ty transport care of the critically ill or critically injured pediatric patient, 24 months of ag e or younger, includes two-way561 communication with transport team before transport, at the re ferring facility and during the transport, including data interpre tation and report; each additional 30 minutes (list separately in addition to code for primary procedure)), and we believe these services are bundled into other services and are not separately payable. We believe these services are similar to CPT codes 99288 (Physician or other qualified health care professional direction of emergency medical systems (ems) emergency care, advanced life sup port), which is also bundled on the PFS. The AMA RUC recommended a work RVU of 1.50 fo r CPT code 99485 and a work RVU of 1.30 for CPT code 99486. On an interim final basis fo r CY 2013, we are assigning CPT codes 99485 and 99486 a PFS procedure status indicator of B ( Payments for covered services are always bundled into payment for other services, which are not sp ecified. If RVUs are shown, they are not used for Medicare payment. If these services ar e covered, payment for them is subsumed by the payment for the services to which they are bundled. (39) Complex Chronic Care Coordination Services TABLE 70: Complex Chronic Care Coordination Services

HCPCS

Code Short Descriptor CY 2012 Work RVU AMA RUC/HCPAC Recommended

Work RVU CY 2013 Interim/Interim

Final Work RVU Agree/Disagree with AMA RUC/HCPAC Recommended

Work RVU CMS Refinement to AMA/HCPAC Recommended Time
99487 Cmplx chron care w/o pt vsit New 1.00 Bundled N/A N/A
99488 Cmplx chron care w/ pt vsit New 2.50 Bundled N/A N/A
99489 Complx chron care addl30 min New 0.50 Bundled N/A N/A

The CPT Editorial Panel created CP T codes 99487, 99488, and 99489 for CY 2013 to describe complex chronic care coordination servi ces that are patient-centered management and support services. In section II.H. of this CY 2013 PFS final rule with comment period, we discuss our broader HHS and CMS multi-year strategy to recognize and support primary care and care562 management under the PFS and commitment to exploring payment approaches and developing proposals to promote primary care within a fee- for-service payment structure. We intend to consider CPT codes 99487 (Complex chronic care coordination services; fi rst hour of clinical staff time directed by a physician or other qualified health care professional with no face-to-face visit, per calendar month), 99488 (Complex chroni c care coordination serv ices; first hour of clinical staff time directed by a physician or other qualified hea lth care professional with one face-to-face visit, per calendar month), and 99489 (Complex chronic care coordination services; each additional 30 minutes of clinical staff time directed by a physician or other qualified health care professional, per calendar mont h (list separately in addition to code for primary procedure)) as part of that larger discussion. At this time, we believe these services are bundled into the services to which they are incident and are not separately payable. The AMA RUC recommended a work RVU of 1.00 for CPT c ode 99487, a work RVU of 2.50 for CPT code 99488, and a work RVU of 0.50 for CPT code 99489. On an interim final basis for CY 2013, we are assigning CPT codes 99487, 99488, and 99489 a PFS procedure status indicator of B ( Payments for covered services are always bundled into payment for other services, which are not specified. If RVUs are shown, they are not used for Medicar e payment. If these services are covered, payment for them is subsumed by the payment for the services to which they are bundled). (40) Transitional Care Management Services TABLE 71: Transitional Care Management Services

HCPCS

Code Short Descriptor CY 2012 Work RVU AMA RUC/HCPAC Recommended

Work RVU CY 2013 Interim/Interim

Final Work RVU Agree/Disagree with AMA RUC/HCPAC Recommended

Work RVU CMS Refinement to AMA/HCPAC Recommended Time
99495 Trans care mgmt 14 day disch New 2.11 2.11 Agree No
99496 Trans care mgmt 7 day disch New 3.05 3.05 Agree Yes563

The CPT Editorial Panel created CPT code s 99495 and 99496 for CY 2013 to describe transitional care provided to patients from an inpatient setting to a home setting over a 30-day period. CPT codes 99495 (Transitional care management services with the following required elements: communication (direct contact, telephone, electronic) with the patient and/or caregiver within 2 business days of discharge medical d ecision making of at leas t moderate complexity during the service period face-to-face visit, within 14 calendar days of discharge) and 99496 (Transitional care management services with the following required elements: communication (direct contact, telephone, electroni c) with the patient and/or care giver within 2 business days of discharge medical decision making of high comp lexity during the service period face-to-face visit, within 7 calendar days of discharge) are discussed in detail in section III.H of this CY 2013 PFS final rule with comment period. In sum, afte r clinical review, we are assigning a work RVU of 2.11 with 40 minutes of intra-service time to CPT code 99495, and a work RVU of 3.05 with 50 minutes of intra-service time to CPT code s 99496 on an interim final basis for CY 2013. (41) Physician Documentation of Face-to-Face visit for Durable Medical Equipment (DME) TABLE 72: Physician Documentation of Face-to-Face visit for Durable Medical Equipment (DME)

HCPCS

Code Short Descriptor CY 2012 Work RVU AMA RUC/HCPAC Recommended

Work RVU CY 2013 Interim/Interim

Final Work RVU Agree/Disagree with AMA RUC/HCPAC Recommended

Work RVU CMS Refinement to AMA/HCPAC Recommended Time
G0454 MD document visit by NPP New N/A 0.18 N/A N/A
Effective January 1, 2013, we have created HCPCS code G0454 (Physician documentation of face-to-face visit for Durable Medical Equipment determination performed by Nurse Practitioner, Physician Assistant or Clinic al Nurse Specialist) for payment to a physician who documents that a PA, NP, or CNS practitioner has performed a face-to-face encounter for564 the list of specified DME covered items. As discussed in section IV.C. of this CY 2013 PFS final rule with comment period, for HCPCS code G0454, we are finalizing a work RVU of 0.18, with 5 minutes of intra-service time and 2 minutes of post-service time, which is a crosswalk to CPT code 99211 (Level 1 office or other outpatient visit, established patient). We believe these values appropriately capture the work and tim e involved in furnishing this service. (42) Other CY 2013 New, Revised, and Potent ially Misvalued CPT Codes Not Specifically Discussed Previously For all other CY 2013 new, revised and potenti ally misvalued CPT codes not specifically discussed previously, we agree with the AMA RUC/HCPAC recommended work RVUs and times and are setting as interim final the work RVUs listed in Table 30. 3. Establishing Interim and Interi m Final Direct PE RVUs for CY 2013 b. Establishing Interim Final Direct PE RVUs for CY 2013 i. Background The AMA RUC provides CMS with recomme ndations regarding direct PE inputs, including clinical labor, supplie s, and equipment, for new, re vised, and potentially misvalued codes. We review the AMA RUC-recommended direct PE inputs on a code-by-code basis, including the recommended facility PE inputs and/or nonfacility PE inputs, as clinically appropriate for the code. We determine whet her we agree with the AMA RUC's recommended direct PE inputs for a service or, if we disagree, we re fine the PE inputs to represent inputs that better reflect our estimate of the PE resources requir ed to furnish the service in the facility and/or nonfacility settings. We also confirm that CP T codes should have faci lity and/or nonfacility direct PE inputs and make changes based on our clinical judgment and any PFS payment policies that would apply to the code. ii. Methodology565 We have accepted for CY 2013, as interim and without refinement, the direct PE inputs based on the recommendations submitted by the AMA RUC for the codes listed in Table KK6. For the remainder of the AMA RUC's direct PE recommendations, we have accepted the PE recommendations submitted by the AMA RUC as inte rim, but with refinements. These codes and the refinements to their direct PE inputs ar e listed in Table KK7. In some cases, we have maintained the interim status of direct PE input s for certain code beyond th e year of the initial recommendation. In those cases, we address the associated direct PE inputs in this section, along with the interim direct PE inputs, es tablished through our review of AMA RUC recommendations. We note that the final CY 2013 PFS direct PE input database reflects the refined direct PE inputs that we are adopting on an interim basis for CY 2013. Th at database is available under downloads for the CY 2013 PFS final rule with comment period on the CMS Web site at: http://www.cms.gov/PhysicianFeeSched/PFSFRN/list.asp#TopOfPage . We also note that the PE RVUs displayed in Addenda B and C reflect the interim values and policies described in this section. All codes adopted on an interim basis are included in Addenda C and are open for

comment. iii. Common and Code-Specific Refinements While Table KK7 details the CY 2013 refinements of the AMA RUC's direct PE recommendations at the code-specific level, we discuss the general na ture of some common refinements and the reasons for particular refinements in the following section. (a) Changes in Physician Time Some direct PE inputs are dire ctly affected by revisions in physician time described in section III.B.3. and III.M.3.a. of this final rule w ith comment period. Specifically, changes in the intra-service portions of the physician time and ch anges in the number or level of postoperative566 visits associated with the global periods result in corresponding changes to direct PE inputs. Changes in Intra-service Physician Time in the Nonfacility Setting. For most codes valued in the nonfacility setting, a portion of the clinical labor time allocat ed to the intra-service period reflects minutes assigned fo r assisting the physician with th e procedure. To the extent that we are refining the times associated with the intra-service portion of such procedures, we have adjusted the corresponding intra-service clin ical labor minutes in the nonfacility setting. For equipment associated with the intra- service period in the nonfacility setting, we generally allocate time based on the typical numbe r of minutes a piece of equipment is being used and, therefore, not available for use with an other patient during that period. In general, we allocate these minutes based on the description of t ypical clinical labor activities. To the extent that we are making changes in the clinical labor times associated with the intra-service portion of procedures, we have adjusted the corresponding e quipment minutes associated with the codes. Changes in the Number or Level of Postope rative Office Visits in the Global Period

. For codes valued with post-service phys ician office visits during a globa l period, most of the clinical labor time allocated to the post-service period refl ects a standard number of minutes allocated for each of those visits. To the extent that we are refining the number or level of postoperative visits, we have modified the clinical staff time in the post-service period to reflect the change. For codes valued with post-service physician office visits during a gl obal period, we allocate standard equipment for each of those visits. To the extent that we are making a change in the number or level of postoperative visits asso ciated with a code, we have adjusted the corresponding equipment minutes. For codes valued with post-service physician office visits during a global period, a certain number of supply items are allocated for each of those office visits. To the extent that we are making a change in the number of postoperative visits, we have adjusted the corresponding supply item quantities asso ciated with the codes. We note that many567 supply items associated with post- service physician office visits ar e allocated for each office visit (for example, a minimum multi-specialty visit pack (SA048) in the CY 2012 direct PE database). For these supply items, the quantities in the di rect PE database should reflect the number of office visits associated with the code's gl obal period. However, some supply items are associated with post-service physician office visits but are only allocated once during the global period because they are typically used during only one of the pos t-service office visits (for example, pack, post-op incision care (suture) (SA 054) in the direct PE database). For these supply items, the quantities in the proposed notice di rect PE database reflec t that single quantity. These refinements are reflected in the fi nal CY 2013 PFS direct PE input database and detailed in Table 73. (b) Equipment Minutes In general, the equipment time inputs reflect the sum of the times w ithin the intra-service period when a clinician is using the piece of equi pment, plus any additional time the piece of equipment is not available for use for anothe r patient due to its us e during the designated procedure. While some services include equipment that is typi cally unavailable during the entire clinical labor service period, certain highly technical pieces of equipment and equipment rooms are less likely to be used by a clinician for all tasks associated with a service and therefore are typically available for other patients during th e pre-service and post-se rvice components of the service period. We adjust those equipment times accordingly. We refer interested stakeholders to our extensive discussion of these policie s in the CY 2012 PFS final rule (76 FR 73182-73183). We are refining the CY 2013 AM A RUC direct PE recommenda tions to conform to these equipment time policies. These refinements ar e reflected in the final CY 2013 PFS direct PE database and detailed in Table 73. (c) Moderate Sedation Inputs568 In the CY 2012 PFS final rule (76 FR 73043-73049) , we finalized a standard package of direct PE inputs for services wher e moderate sedation is considered inherent in the procedure. We are refining the CY 2013 AM A RUC direct PE recommenda tions to conform to these policies. These refinements are reflected in the final CY 2013 PFS dir ect PE database and detailed in Table73. (d) Standard Minutes for Clinical Labor Tasks In general, the minutes associated with cer tain clinical labor tasks are standardized depending on the type of procedure, its typical se tting, its global period, an d the other procedures with which it is typically reported. In the case of some services, the RUC has recommended a numbers of minutes either greater or less than time typically allotted for certain tasks. In those cases, CMS clinical staff has reviewed the devi ations from the standards to determine their clinical appropriateness. Where CMS clinical judgment considers that the standard number of minutes generally accommodates the range of minutes likely to be typical for such activities, the recommended exceptions have not been accepted, and we have refined the interim final direct PE inputs to match the standard times for those tasks. Each of those refinements appears in Table
73. (e) Digestive System (CPT code 44705 and HCPCS Code G0455) The CPT Editorial Panel created CPT code 44705 (Preparation of fecal microbiota for instillation, including assessm ent of donor specimen) and the AMA RUC recommended nonfacility direct PE inputs for this service fo r CY 2013. As discussed in section III.M.3.a. of this final rule, Medicare payment for the prep aration of the donor specimen would only be made if the specimen is ultimately used for the treatment of a beneficiary. Because of this policy, we believe it is appropriate to bundle the preparation and instillation into one payable HCPCS code. For CY 2013, we have created HCPCS code G0 455 (Preparation with instillation of fecal569 microbiota by any method, including assessmen t of donor specimen). HCPCS code G0455 will replace new CPT code 44705 (Preparation of f ecal microbiota for instillation, including assessment of donor specimen) which will have a PFS procedure status indicat or of I (Not valid for Medicare purposes), and incl udes both the work of prepar ation and instillation of the microbiota. In order to establish direct PE inputs for this service that includes both the preparation and instillation, we examined the AMA RUC recommendations for CPT code 44705 and incorporated an additional 17 mi nutes of clinical labor time in the service period to account for pre-service activities like gr eeting and gowning the beneficiary, obtaining the vital signs, providing pre-education/obtaining co nsent, preparing the room and equipment, and preparing the patient and post-service activities like cleaning th e room and providing home care instructions to the beneficiary, based on the amount of time allocat ed for those services in the direct PE inputs for evaluation and management services . We note that we have also included a minimum multispecialty visit pack (SA048) as a supply input for the code and otherwise crosswalked the AMA RUC-recommended supply and equipment inputs from CPT code 44705. (f) Diagnostic Radiology: Abdomen (CPT Codes 72191, 72192, 72193, 72194, 74150, 74160, 74170, 74174, 74175, 74176, 74177, 74178) Generally, we only establish inte rim final direct PE inputs fo r services when the RUC has provided a new recommendation. However, in some cas es, we believe it is necessary to establish new interim final direct PE inputs for codes not recently reviewed by the RUC in order to maintain appropriate relativity between the PE and work components of PFS payment or among those codes and other related codes. For exampl e, this situation can occur when either the physician work of particular codes has been revi ewed without parallel revi ew of the direct PE inputs or when the direct PE inputs of certain co des have been reviewed without parallel review570 of the direct PE inputs of closel y related codes. We addressed th e issue in detail in the CY 2012 PFS final rule (76 FR 73212). Over the past several years, AMA CPT has created codes for diagnostic radiology services that describe CT and computed to mographic angiography (CTA) of the abdomen and pelvis combined while maintaining the current component codes that describe CT and CTA of each region separately. In reviewing both the phys ician work and the direct PE inputs for these services, we have consistently requested that recommendations fo r appropriate valuation of these services consider the whole code set at once. In response to this request, commenters c ontended that the AMA RUC operates under the premise that the values of all the services paid on the PFS are assumed to be accurate and therefore, our request to review component code s is unnecessary and that reviewing and possibly revaluing individual codes solely because they are bundled to crea te a new code, risks rank-order anomalies within families, which could threaten th e relativity of the values of the PFS services. One commenter suggested that our requests wo uld create an endle ss cycle of review. We continue to believe that code sets that include component and combined codes should be reviewed for appropriate revaluing as whole sets instead of in fragments. In fact, we believe that disjointed review, as opposed to comprehens ive review, is itself the most likely cause of rank order anomalies and “endless cy cles of review.” The Act requires CMS to conduct periodic reviews of PFS services [1848(c)(2)(B)] and make appropriate adjustments to misvalued codes [1848(c)(2)(K)]. In consideration of these obligations, we believe that the relative values for these codes must be considered as a whole set instead of in fragments. In the interest of examining the direct PE inputs of these services as a comprehensive set, we have reviewed the direct PE inputs for all of the abdomen and pelv is CT codes and all of the abdomen and pelvis CTA codes as two individual sets. We have st arted from the basis that the most recently571 developed AMA RUC recommendation represents the most current information regarding typical medical practice. For each set of codes, we have established a common set of disposable supplies and medical equipment. We establis hed clinical labor minutes that reflect the fundamental assumption that the component codes should include a base number of minutes for particular tasks and that the number of minutes in the combined codes should reflect efficiencies that occur when the regions are examined together. We are establishing the direct PE input for each of these services on an interim basis for CY 2013, and we have displayed particular refinements to the most recent AMA RUC recommendations or current direct PE inputs for the codes in Table 73. Regarding the supply item called “computer media, optical disk 2.6gb” (SK016), we note that the most recent AMA RU C recommendation included the item with a quantity of 1 as a disposable supply. When reviewing the item in th e direct PE input databa se, we noted that its quantity for other similar codes is 0.1. We believe that quantity better re flects the resource costs of storing digital images for these services. We also note that the item is currently priced at $68.75 in the direct PE input database, and we belie ve that price may be significantly higher than typical prices. Therefore, we are seeking comm ent on the appropriate quan tity and price for the item, which will be set at a quantity of 0.1 for these services on an interim basis for CY 2013. Finally, we note that the direct PE inputs for these services will not be finalized until the associated work RVUs are finalized, consistent with our established policies regarding the concurrent review of work and di rect practice expense inputs. (g) Nuclear Medicine: Diagnostic (CPT Code 78072) When clinically appropriate, the AMA RUC ge nerally recommends the use of supply and equipment items that already exis t in the direct PE database for new, revised, and potentially misvalued codes. Some recommendations incl ude supply or equipment items that are not572 currently in the direct PE data base. In these cases, the AMA RU C has historically recommended a new item be created and has facilitated CMS' pric ing of that item by working with the specialty societies to provide sales invoice s to us. We appreciate the c ontributions of the AMA RUC in that process. We received invoices for several new suppl y and equipment items for CY 2013. We have accepted the majority of these items and adde d them to the direct PE database. For CY 2013, we could not price the new equipment for CPT code 78072 (Parathyroid planar imaging (including subtraction, when perf ormed); with tomographic (SPECT ), and concurrently acquired computed tomography (CT) for anatomical loca lization). We received a recommendation to create a new equipment item in the direct PE database called “gamma camera system, singledual head SPECT/CT” for use in furnishing this se rvice in the nonf acility setting. In order to facilitate pricing the new item, the AMA RUC forwarded information from the specialty society, but that information only include d a letter from the device manuf acturer that offered a price quote. While we recognize that the resource cost s for the equipment is significant, we do not believe that a letter from the manufacturer is ad equate documentation for establishing a price for a new equipment item. In many cases when we cannot adequately price a newly recommended item, we have included the item in the direct PE input database without an associated price. While doing so means that the item does not co ntribute to the calculation of the PE RVU for particular services, it facilitates our ability to incorporate a price once we are able to do so. However, in the case of this new CPT code, b ecause the cost of the item we cannot currently price is disproportionately large relative to the costs reflecte d by remainder of the recommended direct PE inputs, we are contra ctor pricing the technical com ponent of the code for CY 2013, on an interim basis, until the newl y recommended equipment item can be appropriately priced. (h) Pathology and Laboratory: Chemistry (CPT Code 86153)573 The AMA RUC submitted direct PE input recommendations for CPT code 86153 (Cell enumeration using immunologic selection and iden tification in fluid specimen (eg, circulating tumor cells in blood); physician interpretation and report, when require d) that describes a laboratory physician interpretation code. As we di scuss in section III.M.3. a. of this final rule with comment period, CPT code 86153 is a profe ssional component-only CPT code that will be considered a “clinical laboratory interpretation service,” which is one of the current categories of PFS pathology services under the definition of p hysician pathology services at §415.130(b)(4). This code must be billed with the “26” modifier to be paid under the PFS. Therefore, CPT code 86153 -26 should be valued exclusiv ely without direct practice expe nse inputs. Therefore, we are not accepting the recommended di rect PE inputs for CPT code 86153. (i) Pathology and Laboratory: Surgi cal Pathology (CPT Codes 88300, 88302, 88304, 88305, 88307, 88309) For surgical pathology CPT codes 88300, 88302, 88304, 88305, 88307, 88309 (Surgical Pathology, Levels I through VI), the AMA RUC recommended creating several new supply and equipment items in direct PE input database th at we will not incorporat e for CY 2013 in addition to several new direct PE inputs that we are adopting on an interi m basis. The new supply items that we will not incorporate we re called “specimen, solvent, and formalin disposal cost,” and “courier transportation costs.” We do not believ e that specimen and supply disposal or courier costs for transporting specimens ar e appropriately considered as disposable medical supplies. Instead, we believe the costs described by these recommendations are incorporated into the PE RVUs for these services through th e indirect PE allocation. We not e that the current direct PE inputs for these and similar serv ices across the PFS do not incl ude these kinds of costs as disposable supplies. In addition to the recommendation to incl ude these new supply items, the AMA RUC574 recommended that we create new equipment items called “equipment maintenance cost,” “Copath System with maintenance contract,” and “Copath software” as direct PE inputs for these codes. Our standard equipment cost per mi nute calculation includes a maintenance factor to incorporate costs related to maintenance in am ortizing the cost of the equipment itself. Therefore, we will not incorporate separate main tenance costs for particular items. Regarding the “Copath” system and software equipmen t, the AMA RUC forwarded materials from a manufacturer that included a descri ption of a computer system that is used to interface with other data systems to provide inbound demographic in formation and export laboratory results and billing information. Based on the way those func tionalities were presente d in this information, we believe that this computer system and asso ciated software reflect s an indirect practice expense since the clerical and ot her administrative functionality seem central to its purpose. We note that no similar equipment is currently included as a direct PE input for these services. All direct PE inputs for these services are inte rim for CY 2013 and open to comment. We would consider additional information regarding whether this computer system and associated software might be considered a direct co st as medical equipment associated with furnishing the technical component of these surgical pa thology services for CY 2014 ru lemaking. We are especially interested in understandi ng the clinical functional ity of the equipment in relation to the services being furnished. In addition to this information, we are al so seeking additional public comment regarding the appropriate assumptions regard ing the direct PE inputs for thes e services. We note that the AMA RUC recommendations for these potentially misvalued codes were developed based on an underlying assumption regarding the typical numbe r of blocks used each time a service is reported. The number of blocks assumed to be us ed has significant impact on the quantity of other supplies and the number of clinical labor and equipment minutes assigned as direct PE575 inputs to each code. Afte r conducting an initia l clinical review of these direct PE inputs, we are concerned that the number of blocks assumed for each code may be inaccurate. For 88300, no blocks are assumed. For 88302, one block is assumed. For 88304 and 88305, the assumed number of blocks typically used is 2. For 88307, the assumed number of blocks is 12 and for 88309, the typical number of blocks is assumed to be 18. We are accepting the AMA RUC’s recommended direct PE inputs th at derive from these assumpti ons on an interim basis for CY 2013, but we are seeking independe nt evidence regardi ng the appropriate number of blocks to assume as typical for each of these services. We are requesting public comment regarding the appropriate number of blocks a nd urge the AMA RUC and interest ed medical specialty societies to provide corroborating, independent evidence that the number of blocks assumed in the current direct PE input recommendations is typical prior to finalizing the direct PE inputs for these services. (j) Pathology and Laboratory: Cy topathology (CPT Codes 88120 and 88121) The CPT Editorial Panel created CPT code s 88120 (Cytopathology, in situ hybridization (eg, FISH), urinary tract specimen with morphom etric analysis, 3-5 molecular probes, each specimen; manual) and 88121 (Cyt opathology, in situ hybridizati on (eg, FISH), urinary tract specimen with morphometric analysis, 3-5 mol ecular probes, each spec imen; using computerassisted technology) to describe in situ hybridi zation testing using urine samples, effective for
CY 2011. As we explain in section III.M.3.a. of this final rule with comment period, we believe that the work and direct PE inputs for existing CPT codes 88365, 88367, and 88368 should be reviewed alongside CPT codes 88120 and 88121 to en sure the appropriate relativity between these two sets of services (76 FR 73153 th rough 73154). The AMA RUC has stated that it intends to do so after CY 2012 utilization data ar e available to assess how these services are576 being billed. We agree with this approach, and are maintaining th e interim status for the direct PE inputs for CPT code 88120 and 88121 until we review CPT codes 88120 and 88121 alongside CPT codes 88365, 88367, and 88368 for CY 2014. Distinct from that forthcoming review, stak eholders have informed us of two separate issues related to the inte rim direct PE inputs for these services . Two stakeholders have examined the AMA RUC recommendations and found miscal culations in the recommended equipment minutes. The information we reviewed suggest ed that that the recommended times of 107 minutes for the ThemoBrite equipment (E P088) for 88120 and 26.75 minutes for 88121 were derived in error because the division for the typi cal batch sizes of 3 and 6, respectively, occurred twice. The stakeholders also presented info rmation that the recommended minutes for the Olympus BX41 Fluorescent Microscope (without filters or camera) (EP092) as a direct PE input for CPT code 88120 ought to have been 73 minute s, instead of 1.33 minutes. Finally, the stakeholders provided information suggesting the minutes for the IkoniScope (EP090) and IkoniLan software (EP091) include d as direct PE inputs for CPT code 88121 were intended to be 29.7 minutes, instead of 2.97. Upon clinical review of this information, we agree with the stakeholders regarding the in tention of these recommendations, and have refined the CY 2013 direct PE input database accordingly. These stakeholders also s uggested that CMS should incr ease the price of the supply “UroVysion test kit” (SA105) by build ing in an “efficiency factor” to account for the kits that are purchased by practitioners and used in tests th at fail. The stakeholders provided documentation suggesting that a certain failure rate is inherent in the procedure. The prices associated with supply inputs in th e direct PE input database reflect the price per unit of each supply. Since the current PE methodology relies on the inputs for each service reflecting the typical direct pract ice expense costs for each service, and the supply costs for the577 failed tests are not used in furnishing PFS se rvices, we do not believe that the methodology accommodates a failure rate in allocating the cost of disposable medical supplies. Therefore, we are not adjusting the price input for “UroVysion test kit” (SA105) in the direct PE input database. (j) Psychiatry (CPT Codes 90791, 90832, 90834, 90837) For CY 2013, the CPT Editorial Panel has repl aced the current psychiatry/psychotherapy CPT codes with a new structure that allows for the separate reporting of E/M codes, eliminates the site-of-service differential, establishes CPT codes for crisis, and creates a series of add-on CPT codes to psychotherapy to describe interac tive complexity and medication management. As we note in section III.M.3.a. of this final rule with commenter period, because related specialty societies have not yet surveyed some of the new CPT codes, namely, the new CPT codes for psychotherapy for crisis, interactive complexit y, and pharmacologic management, we anticipate re-reviewing the values for all the codes in th e family in the near future. For CY 2013, our general approach is to maintain the current values , or as close to the current values as possible, given the consolidation of multiple CY 2012 CP T codes into a single CY 2013 CPT code, for these service on an interim basis, pending re-review. The AMA RUC submitted direct PE input recommendations for codes in this family that included significant reductions in the direct PE costs associated with the predecessor codes. For most of the new codes, we believe that acc epting these recommended reductions in direct practice expense conforms to our general approach of maintaining the current values for these services since many practitioners who furnish thes e services will now report concurrent medical evaluation and management services with PE values that will offset the differences in total PE values between the new and old psychotherapy c odes. However, for practitioners who do not furnish medical evaluation and management services, there are no corresponding PE value578

increases to offset the recommended reductions in the direct PE inputs for these codes. Therefore, instead of accepting the recommended direct PE inputs for the new CPT codes that describe services primarily furnished by practitio ners who do not also re port medical evaluation and management services, we will crosswalk the PE RVUs from the CY 2012 codes that describe the same services. We believe this cros swalk will effectively maintain the total value of the services, pending a comprehensive review of the code family. The CPT codes with CY 2013 PE RVU crosswalks are: 90791 (Psychiatric diagnostic evaluation) , 90832 (Psychotherapy, 30 minutes with patient and/or family membe r), 90834 (Psychotherapy, 45 minutes with patient and/or family member), and 90837 (Psychothera py, 60 minutes with patient and/or family member). For CY 2013, we are crosswalking the PE RVUs developed for the predecessor codes for CY 2012. We note that the PE RVUs used for these services will correspond with the CY 2013 fully implemented values instead of the tran sition values since this interim policy is to maintain the current values relative to the new coding structure for the services, not exempt the services from the final year of the PPIS transition, as described in section III.A. of this final rule with comment period. The values in Addendum C re flect the interim PE RVUs for these codes. (k) Medicine: Gastroenterology (CPT Code 91112) The AMA RUC submitted direct PE input recommendations for CPT code 91112 (Gastrointestinal transit and pr essure measurement, stomach th rough colon, wireless capsule, with interpretation and report). The recommendati ons reflect an assumption that the patient data receiver would be typically used for 7200 minutes , or 5 days, for each service. However, product information available on the device manuf acturer’s website specifies a 24 to 48 hour capsular passage time. Based on this informati on and CMS clinical review, we believe that assigning 2880 minutes to the data receiver is ap propriate based on the assumption that 2 days reflects the maximum typical time for passage of the capsule. We also note that while the AMA579 RUC’s recommendation included the capsule and st andardized meal as separate disposable items, the submitted invoice priced the items together, so the new supply item created in the direct PE input database reflects the combin ed items as a single disposable supply. (l) Neurology and Neuromuscular Procedures : Intraoperative Neurophysiology (CPT Codes 95940, 95941 and HCPCS Code G0453) Effective January 1, 2013, the CPT Edito rial Panel is deleting CPT code 95920 (Intraoperative neurophysiology testing, per hour (List separately in addition to code for primary procedure)), and is replacing it with CPT codes 95940 (Continuous intraoperative neurophysiology monitoring in the operating ro om, one on one monitoring requiring personal attendance, each 15 minutes) and CPT code 95941 (Continuous intraoperative neurophysiology monitoring, from outside the operating room (remote or nearby) or for monitoring of more than one case while in the oper ating room, per hour). As we note in section III.M.3.a. of this fina l rule with comment period, we have created HCPCS code G0453 (Continuous in traoperative neurophysiology monitoring, from outside the operating room (remote or nearby), per patient, (attention directed excl usively to one patient) each 15 minutes (list in addition to primar y procedure)), effective January 1, 2013 to replace CPT code 95941 for Medicare purposes. CPT code 95941 will have a PFS procedure status indicator of I (Not valid for Medicare purposes. Medicare uses another code for the reporting of and the payment for these services) for CY 2013. CPT code 95940, which describes continuous intraoperative neurophysiology monitoring in the ope rating room for one patient at a time, will be payable on the PFS for CY 2013. The AMA RUC provided direct PE input recommendations for CPT codes 95940 and 95941. However, we do not believe that these se rvices are furnished to patients outside of facility settings. Medicare makes payment for technical inputs (labor , supplies, equipment,580 capital, and overhead) to th e facility when services are perfor med in a facility setting. For these services, the patient would receive this servi ce in the ASC or hospita l setting and payment for any technical services, in cluding those for remote monitoring, should be included in the facility payment. We do not believe it would be appropriate to incorporate nonfacility direct PE inputs or develop nonfacility PE RVUs for CPT code 95940 and newly created HCPCS code G0453 for CY 2013. We do not believe that these services incur PFS direct practice expense costs when furnished to patients in the facility setting. Ther efore, we are developing facility PE RVUs for this service based on no direct PE inputs. (m) Neurology and Neuromuscular Procedures: Sleep Medicine Testing CPT Codes 95782, 95783) The AMA RUC submitted direct PE input recommendations for new CPT codes describing pediatric polysom onography: 95782 (Polysomnography, youn ger than 6 years, 4 or more) and 95783 (Polysomnography, younger than 6 year s, w/cpap). We note that in addition to refining minutes assigned to certain labor tasks based on CMS clinical ju dgment, we have not accepted the AMA RUC’s recommendation to creat e a new equipment item ‘crib’ for use in these services. We do not believe th at a crib would typically be used in this service, and we have incorporated the bedroom furniture including a hospital bed and a reclin ing chair as typical equipment for this service. (n) Special Dermatological Proc edures (CPT Codes 96920, 96921, 96922) The AMA RUC provided new direct PE input recommendations for CPT codes 96920(Laser treatment for inflammatory skin disease (psoriasis); total area less than 250 sq cm), 96921 (Laser treatment for inflammatory skin dis ease, (psoriasis); between 250 sq cm to 500 sq cm), and 96922 (Laser treatment for inflammatory skin disease, (psoriasis); over 500 sq cm). Included in the new direct PE inputs for these services was a disposable laser tip (SF028).581 This disposable item, priced at $290 in the direct PE input database, was not previously included as a direct PE input for these services. The recommendation did not provide a rationale as to why this highly priced disposable should be in cluded as a direct PE input for these existing services when the codes have not previously incl uded this item or any similarly priced disposable supply. Therefore, we are refining the RUC recommendation by removing the supply item SF028 from 96920, 96921, and 96922. We note that the direct PE inputs for these codes are interim for CY 2013, and we will consider a ny additional information and public comments regarding the typical use of this supply in furnis hing these services prior to finalizing the direct PE inputs for CY 2014. (o) Transitional Care Management Services (CPT Codes 99495, 99496) The CPT Editorial Panel created CPT codes 99495 and 99496 for CY 2013 to describe transitional care provided to patients from an inpatient setting to a home setting over a 30-day period. The AMA RUC submitted direct PE input r ecommendations for these services that we are accepting with the following refinements. As discussed in detail in sect ion III.H of this CY 2013 PFS final rule with comment, we agree with the AMA RUC recommendation to incl ude 45 minutes of RN/LPN time for CPT code 99495 for dedicated to non-face-to-face care manage ment activities. However, for CPT code 99496, we are refining the 60 minutes of recommende d clinical labor time for a RN/LPN nurse blend dedicated to non-face-to-face care manageme nt activities from 60 minutes to 70 minutes. We believe that the total clini cal labor staff time and physician in tra-service work time that the AMA RUC-recommended for non-face-to-face care ma nagement activities was accurate for both codes, but that the proportionality between physic ian work and clinical staff time should be refined to reflect greater clinical staff time in 99496. We also note that we are refining the AMA RU C recommendation by incorporating the clinical582 labor inputs for dedicated to non- face-to-face care management act ivities as faci lity inputs.

TABLE 73: CPT Codes with Accepted Direc t PE Recommendations for CY 2013 Interim Codes CPT Code CPT Code Description

20985 Cptr-asst dir ms px 24160 Remove elbow joint implant 24371 Revise reconst elbow joint 29828 Arthroscopy biceps tenodesis 31648 Bronchial valve addl insert 31649 Bronchial valve remov init 31651 Bronchial valve remov addl 31660 Bronch thermoplsty 1 lobe 31661 Bronch thermoplsty 2/> lobes 33430 Replacement of mitral valve 33533 Cabg arterial single 36227 Place cath xtrnl carotid 37211 Thrombolytic art therapy 37212 Thrombolytic venous therapy 37213 Thromblytic art/ven therapy 37214 Cessj therapy cath removal 66982 Cataract surgery complex 66984 Cataract surg w/iol 1 stage 77082 Dxa bone density vert fx 90792 Psych diag eval w/med srvcs 90833 Psytx pt&/fam w/e&m 30 min 90837 Psytx pt&/family 60 minutes 90838 Psytx pt&/fam w/e&m 60 min 90845 Psychoanalysis 90846 Family psytx w/o patient 90847 Family psytx w/patient 90853 Group psychotherapy 92286 Internal eye photography 93016 Cardiovascular stress test 93018 Cardiovascular stress test 95017 Perq & icut allg test venoms 95018 Perq&ic allg test drugs/biol 95079 Ingest challenge addl 60 min 95860 Muscle test one limb 95866 Muscle test hemidiaphragm 95867 Muscle test cran nerv unilat583

CPT Code CPT Code Description

95869 Muscle test thor paraspinal 95870 Muscle test nonparaspinal 95925 Somatosensory testing 95926 Somatosensory testing 95928 C motor evoked uppr limbs 95929 C motor evoked lwr limbs 95938 Somatosensory testing 95939 C motor evoked upr&lwr limbs
TABLE 74: CPT Codes with Refined Direct PE Recommendations for CY 2013 Interim Codes

CPT Code CPT Code Description CMS Code CMS Code Description NonFac / Fac Labor Activity (if applicable) AMA RUC Recomme ndation or

Current

Value (min or

qty) CMS Refine ment (min or qty) Comment

ED0

04 camera, digital (6 mexapixel) NF 29 14 Refined equipment time to reflect typical use exclusive to patient

EF01

4 light, surgical NF 29 14 Refined equipment time to reflect typical use exclusive to patient

EF01

5 mayo stand NF 29 14 Refined equipment time to reflect typical use exclusive to patient 11300 Shave skin lesion 0.5

cm/<

EF03 1 table, power NF 29 14 Refined equipment time to reflect typical use exclusive to patient584

CPT Code CPT Code Description CMS Code CMS Code Description NonFac / Fac Labor Activity (if applicable) AMA RUC Recomme ndation or

Current

Value (min or

qty) CMS Refine ment (min or qty) Comment

EQ1

10 electrocauteryhyfrecator, up to 45 watts NF 29 0 CMS clinical review; not described as typical in work vignette

EQ1

37 instrument pack, basic ($500- $1499) NF 29 24 Refined equipment time to reflect typical use exclusive to patient

EQ3

51 Smoke Evacuator(tubing,

covering, etc.)

with stand NF 29 14 Refined equipment time to reflect typical use exclusive to patient L037

D RN/LPN/MTA NF Clean Surgical Instrument Package 1 10 Standardi zed time input SB00

3 cover, probe (cryosurgery) NF 1 0 CMS clinical review SB02

7 gown, staff, impervious NF 2 1 Duplicativ e SB03

3 mask, surgical NF 2 1 Duplicativ e SC02

9 needle, 18-27g NF 1 0 CMS clinical review

11301 Shave skin lesion 0.6-

1.0 cm ED0 04 camera, digital (6 mexapixel) NF 32 17 Refined equipment time to reflect typical use exclusive to patient585

CPT Code CPT Code Description CMS Code CMS Code Description NonFac / Fac Labor Activity (if applicable) AMA RUC Recomme ndation or

Current

Value (min or

qty) CMS Refine ment (min or qty) Comment

EF01

4 light, surgical NF 32 17 Refined equipment time to reflect typical use exclusive to patient

EF01

5 mayo stand NF 32 17 Refined equipment time to reflect typical use exclusive to patient

EF03

1 table, power NF 32 17 Refined equipment time to reflect typical use exclusive to patient

EQ1

10 electrocauteryhyfrecator, up to 45 watts NF 32 0 CMS clinical review; not described as typical in work vignette

EQ1

37 instrument pack, basic ($500- $1499) NF 32 27 Refined equipment time to reflect typical use exclusive to patient

EQ3

51 Smoke Evacuator(tubing,

covering, etc.)

with stand NF 32 17 Refined equipment time to reflect typical use exclusive to patient586

CPT Code CPT Code Description CMS Code CMS Code Description NonFac / Fac Labor Activity (if applicable) AMA RUC Recomme ndation or

Current

Value (min or

qty) CMS Refine ment (min or qty) Comment

L037

D RN/LPN/MTA NF Clean Surgical Instrument Package 1 10 Standardi zed time input SB00

3 cover, probe (cryosurgery) NF 1 0 CMS clinical review SB02

7 gown, staff, impervious NF 2 1 Duplicativ e SB03

3 mask, surgical NF 2 1 Duplicativ e SC02

9 needle, 18-27g NF 1 0 CMS clinical review

ED0

04 camera, digital (6 mexapixel) NF 37 20 Refined equipment time to reflect typical use exclusive to patient

EF01

4 light, surgical NF 37 20 Refined equipment time to reflect typical use exclusive to patient

EF01

5 mayo stand NF 37 20 Refined equipment time to reflect typical use exclusive to patient 11302 Shave skin lesion 1.1-

2.0 cm

EF03 1 table, power NF 37 20 Refined equipment time to reflect typical use exclusive to patient587

CPT Code CPT Code Description CMS Code CMS Code Description NonFac / Fac Labor Activity (if applicable) AMA RUC Recomme ndation or

Current

Value (min or

qty) CMS Refine ment (min or qty) Comment

EQ1

10 electrocauteryhyfrecator, up to 45 watts NF 37 0 CMS clinical review; not described as typical in work vignette

EQ1

37 instrument pack, basic ($500- $1499) NF 37 30 Refined equipment time to reflect typical use exclusive to patient

EQ3

51 Smoke Evacuator(tubing,

covering, etc.)

with stand NF 37 20 Refined equipment time to reflect typical use exclusive to patient L037

D RN/LPN/MTA NF Clean Surgical Instrument Package 1 10 Standardi zed time input SB00

3 cover, probe (cryosurgery) NF 1 0 CMS clinical review SB02

7 gown, staff, impervious NF 2 1 Duplicativ e SB03

3 mask, surgical NF 2 1 Duplicativ e SC02

9 needle, 18-27g NF 1 0 CMS clinical review

11303 Shave skin lesion >2.0 cm ED0 04 camera, digital (6 mexapixel) NF 41 22 Refined equipment time to reflect typical use exclusive to patient588

CPT Code CPT Code Description CMS Code CMS Code Description NonFac / Fac Labor Activity (if applicable) AMA RUC Recomme ndation or

Current

Value (min or

qty) CMS Refine ment (min or qty) Comment

EF01

4 light, surgical NF 41 22 Refined equipment time to reflect typical use exclusive to patient

EF01

5 mayo stand NF 41 22 Refined equipment time to reflect typical use exclusive to patient

EF03

1 table, power NF 41 22 Refined equipment time to reflect typical use exclusive to patient

EQ1

10 electrocauteryhyfrecator, up to 45 watts NF 41 0 CMS clinical review; not described as typical in work vignette

EQ1

37 instrument pack, basic ($500- $1499) NF 41 32 Refined equipment time to reflect typical use exclusive to patient

EQ3

51 Smoke Evacuator(tubing,

covering, etc.)

with stand NF 41 22 Refined equipment time to reflect typical use exclusive to patient589

CPT Code CPT Code Description CMS Code CMS Code Description NonFac / Fac Labor Activity (if applicable) AMA RUC Recomme ndation or

Current

Value (min or

qty) CMS Refine ment (min or qty) Comment

L037

D RN/LPN/MTA NF Clean Surgical Instrument Package 1 10 Standardi zed time input SB00

3 cover, probe (cryosurgery) NF 1 0 CMS clinical review SB02

7 gown, staff, impervious NF 2 1 Duplicativ e SB03

3 mask, surgical NF 2 1 Duplicativ e SC02

9 needle, 18-27g NF 1 0 CMS clinical review

ED0

04 camera, digital (6 mexapixel) NF 29 17 Refined equipment time to reflect typical use exclusive to patient

EF01

4 light, surgical NF 29 17 Refined equipment time to reflect typical use exclusive to patient

EF01

5 mayo stand NF 29 17 Refined equipment time to reflect typical use exclusive to patient 11305 Shave skin lesion 0.5

cm/<

EF03 1 table, power NF 29 17 Refined equipment time to reflect typical use exclusive to patient590

CPT Code CPT Code Description CMS Code CMS Code Description NonFac / Fac Labor Activity (if applicable) AMA RUC Recomme ndation or

Current

Value (min or

qty) CMS Refine ment (min or qty) Comment

EQ1

10 electrocauteryhyfrecator, up to 45 watts NF 29 0 CMS clinical review; not described as typical in work vignette

EQ1

37 instrument pack, basic ($500- $1499) NF 29 27 Refined equipment time to reflect typical use exclusive to patient

EQ3

51 Smoke Evacuator(tubing,

covering, etc.)

with stand NF 29 17 Refined equipment time to reflect typical use exclusive to patient L037

D RN/LPN/MTA NF Clean Surgical Instrument Package 1 10 Standardi zed time input SB00

3 cover, probe (cryosurgery) NF 1 0 CMS clinical review SB02

7 gown, staff, impervious NF 2 1 Duplicativ e SB03

3 mask, surgical NF 2 1 Duplicativ e SC02

9 needle, 18-27g NF 1 0 CMS clinical review

11306 Shave skin lesion 0.6-

1.0 cm ED0 04 camera, digital (6 mexapixel) NF 31 17 Refined equipment time to reflect typical use exclusive to patient591

CPT Code CPT Code Description CMS Code CMS Code Description NonFac / Fac Labor Activity (if applicable) AMA RUC Recomme ndation or

Current

Value (min or

qty) CMS Refine ment (min or qty) Comment

EF01

4 light, surgical NF 31 17 Refined equipment time to reflect typical use exclusive to patient

EF01

5 mayo stand NF 31 17 Refined equipment time to reflect typical use exclusive to patient

EF03

1 table, power NF 31 17 Refined equipment time to reflect typical use exclusive to patient

EQ1

10 electrocauteryhyfrecator, up to 45 watts NF 31 0 CMS clinical review; not described as typical in work vignette

EQ1

37 instrument pack, basic ($500- $1499) NF 31 27 Refined equipment time to reflect typical use exclusive to patient

EQ3

51 Smoke Evacuator(tubing,

covering, etc.)

with stand NF 31 17 Refined equipment time to reflect typical use exclusive to patient592

CPT Code CPT Code Description CMS Code CMS Code Description NonFac / Fac Labor Activity (if applicable) AMA RUC Recomme ndation or

Current

Value (min or

qty) CMS Refine ment (min or qty) Comment

L037

D RN/LPN/MTA NF Assist physician in performing procedure 10 18 Conformi ng to physician time L037

D RN/LPN/MTA NF Clean Surgical Instrument Package 1 10 Standardi zed time input SB00

3 cover, probe (cryosurgery) NF 1 0 CMS clinical review SB02

7 gown, staff, impervious NF 2 1 Duplicativ e SB03

3 mask, surgical NF 2 1 Duplicativ e SC02

9 needle, 18-27g NF 1 0 CMS clinical review

ED0

04 camera, digital (6 mexapixel) NF 37 21 Refined equipment time to reflect typical use exclusive to patient

EF01

4 light, surgical NF 37 21 Refined equipment time to reflect typical use exclusive to patient

EF01

5 mayo stand NF 37 21 Refined equipment time to reflect typical use exclusive to patient 11307 Shave skin lesion 1.1-

2.0 cm

EF03 1 table, power NF 37 21 Refined equipment time to reflect typical use exclusive to patient593

CPT Code CPT Code Description CMS Code CMS Code Description NonFac / Fac Labor Activity (if applicable) AMA RUC Recomme ndation or

Current

Value (min or

qty) CMS Refine ment (min or qty) Comment

EQ1

10 electrocauteryhyfrecator, up to 45 watts NF 37 0 CMS clinical review; not described as typical in work vignette

EQ1

37 instrument pack, basic ($500- $1499) NF 37 31 Refined equipment time to reflect typical use exclusive to patient

EQ3

51 Smoke Evacuator(tubing,

covering, etc.)

with stand NF 37 21 Refined equipment time to reflect typical use exclusive to patient L037

D RN/LPN/MTA NF Clean Surgical Instrument Package 1 10 Standardi zed time input SB00

3 cover, probe (cryosurgery) NF 1 0 CMS clinical review SB02

7 gown, staff, impervious NF 2 1 Duplicativ e SB03

3 mask, surgical NF 2 1 Duplicativ e SC02

9 needle, 18-27g NF 1 0 CMS clinical review

11308 Shave skin lesion >2.0 cm ED0 04 camera, digital (6 mexapixel) NF 42 24 Refined equipment time to reflect typical use exclusive to patient594

CPT Code CPT Code Description CMS Code CMS Code Description NonFac / Fac Labor Activity (if applicable) AMA RUC Recomme ndation or

Current

Value (min or

qty) CMS Refine ment (min or qty) Comment

EF01

4 light, surgical NF 42 24 Refined equipment time to reflect typical use exclusive to patient

EF01

5 mayo stand NF 42 24 Refined equipment time to reflect typical use exclusive to patient

EF03

1 table, power NF 42 24 Refined equipment time to reflect typical use exclusive to patient

EQ1

10 electrocauteryhyfrecator, up to 45 watts NF 42 0 CMS clinical review; not described as typical in work vignette

EQ1

37 instrument pack, basic ($500- $1499) NF 42 34 Refined equipment time to reflect typical use exclusive to patient

EQ3

51 Smoke Evacuator(tubing,

covering, etc.)

with stand NF 42 24 Refined equipment time to reflect typical use exclusive to patient595

CPT Code CPT Code Description CMS Code CMS Code Description NonFac / Fac Labor Activity (if applicable) AMA RUC Recomme ndation or

Current

Value (min or

qty) CMS Refine ment (min or qty) Comment

L037

D RN/LPN/MTA NF Clean Surgical Instrument Package 1 10 Standardi zed time input SB00

3 cover, probe (cryosurgery) NF 1 0 CMS clinical review SB02

7 gown, staff, impervious NF 2 1 Duplicativ e SB03

3 mask, surgical NF 2 1 Duplicativ e SC02

9 needle, 18-27g NF 1 0 CMS clinical review

ED0

04 camera, digital (6 mexapixel) NF 34 20 Refined equipment time to reflect typical use exclusive to patient

EF01

4 light, surgical NF 34 20 Refined equipment time to reflect typical use exclusive to patient

EF01

5 mayo stand NF 34 20 Refined equipment time to reflect typical use exclusive to patient 11310 Shave skin lesion 0.5

cm/<

EF03 1 table, power NF 34 20 Refined equipment time to reflect typical use exclusive to patient596

CPT Code CPT Code Description CMS Code CMS Code Description NonFac / Fac Labor Activity (if applicable) AMA RUC Recomme ndation or

Current

Value (min or

qty) CMS Refine ment (min or qty) Comment

EQ1

10 electrocauteryhyfrecator, up to 45 watts NF 34 0 CMS clinical review; not described as typical in work vignette

EQ1

37 instrument pack, basic ($500- $1499) NF 34 30 Refined equipment time to reflect typical use exclusive to patient

EQ3

51 Smoke Evacuator(tubing,

covering, etc.)

with stand NF 34 20 Refined equipment time to reflect typical use exclusive to patient L037

D RN/LPN/MTA NF Clean Surgical Instrument Package 1 10 Standardi zed time input SB00

3 cover, probe (cryosurgery) NF 1 0 CMS clinical review SB02

7 gown, staff, impervious NF 2 1 Duplicativ e SB03

3 mask, surgical NF 2 1 Duplicativ e SC02

9 needle, 18-27g NF 1 0 CMS clinical review

11311 Shave skin lesion 0.6-

1.0 cm ED0 04 camera, digital (6 mexapixel) NF 34 18 Refined equipment time to reflect typical use exclusive to patient597

CPT Code CPT Code Description CMS Code CMS Code Description NonFac / Fac Labor Activity (if applicable) AMA RUC Recomme ndation or

Current

Value (min or

qty) CMS Refine ment (min or qty) Comment

EF01

4 light, surgical NF 34 18 Refined equipment time to reflect typical use exclusive to patient

EF01

5 mayo stand NF 34 18 Refined equipment time to reflect typical use exclusive to patient

EF03

1 table, power NF 34 18 Refined equipment time to reflect typical use exclusive to patient

EQ1

10 electrocauteryhyfrecator, up to 45 watts NF 34 0 CMS clinical review; not described as typical in work vignette

EQ1

37 instrument pack, basic ($500- $1499) NF 34 28 Refined equipment time to reflect typical use exclusive to patient

EQ3

51 Smoke Evacuator(tubing,

covering, etc.)

with stand NF 34 18 Refined equipment time to reflect typical use exclusive to patient598

CPT Code CPT Code Description CMS Code CMS Code Description NonFac / Fac Labor Activity (if applicable) AMA RUC Recomme ndation or

Current

Value (min or

qty) CMS Refine ment (min or qty) Comment

L037

D RN/LPN/MTA NF Assist physician in performing procedure 11 17 Conformi ng to physician time L037

D RN/LPN/MTA NF Clean Surgical Instrument Package 1 10 Standardi zed time input SB00

3 cover, probe (cryosurgery) NF 1 0 CMS clinical review SB02

7 gown, staff, impervious NF 2 1 Duplicativ e SB03

3 mask, surgical NF 2 1 Duplicativ e SC02

9 needle, 18-27g NF 1 0 CMS clinical review

ED0

04 camera, digital (6 mexapixel) NF 43 17 Refined equipment time to reflect typical use exclusive to patient

EF01

4 light, surgical NF 43 17 Refined equipment time to reflect typical use exclusive to patient

EF01

5 mayo stand NF 43 17 Refined equipment time to reflect typical use exclusive to patient 11312 Shave skin lesion 1.1-

2.0 cm

EF03 1 table, power NF 43 17 Refined equipment time to reflect typical use exclusive to patient599

CPT Code CPT Code Description CMS Code CMS Code Description NonFac / Fac Labor Activity (if applicable) AMA RUC Recomme ndation or

Current

Value (min or

qty) CMS Refine ment (min or qty) Comment

EQ1

10 electrocauteryhyfrecator, up to 45 watts NF 43 0 CMS clinical review; not described as typical in work vignette

EQ1

37 instrument pack, basic ($500- $1499) NF 43 37 Refined equipment time to reflect typical use exclusive to patient

EQ3

51 Smoke Evacuator(tubing,

covering, etc.)

with stand NF 43 17 Refined equipment time to reflect typical use exclusive to patient L037

D RN/LPN/MTA NF Clean Surgical Instrument Package 1 10 Standardi zed time input SB00

3 cover, probe (cryosurgery) NF 1 0 CMS clinical review SB02

7 gown, staff, impervious NF 2 1 Duplicativ e SB03

3 mask, surgical NF 2 1 Duplicativ e SC02

9 needle, 18-27g NF 1 0 CMS clinical review

11313 Shave skin lesion >2.0 cm ED0 04 camera, digital (6 mexapixel) NF 43 30 Refined equipment time to reflect typical use exclusive to patient600

CPT Code CPT Code Description CMS Code CMS Code Description NonFac / Fac Labor Activity (if applicable) AMA RUC Recomme ndation or

Current

Value (min or

qty) CMS Refine ment (min or qty) Comment

EF01

4 light, surgical NF 43 30 Refined equipment time to reflect typical use exclusive to patient

EF01

5 mayo stand NF 43 30 Refined equipment time to reflect typical use exclusive to patient

EF03

1 table, power NF 43 30 Refined equipment time to reflect typical use exclusive to patient

EQ1

10 electrocauteryhyfrecator, up to 45 watts NF 43 0 CMS clinical review; not described as typical in work vignette

EQ1

37 instrument pack, basic ($500- $1499) NF 43 40 Refined equipment time to reflect typical use exclusive to patient

EQ3

51 Smoke Evacuator(tubing,

covering, etc.)

with stand NF 43 30 Refined equipment time to reflect typical use exclusive to patient601

CPT Code CPT Code Description CMS Code CMS Code Description NonFac / Fac Labor Activity (if applicable) AMA RUC Recomme ndation or

Current

Value (min or

qty) CMS Refine ment (min or qty) Comment

L037

D RN/LPN/MTA NF Clean Surgical Instrument Package 1 10 Standardi zed time input SB00

3 cover, probe (cryosurgery) NF 1 0 CMS clinical review SB02

7 gown, staff, impervious NF 2 1 Duplicativ e SB03

3 mask, surgical NF 2 1 Duplicativ e SC02

9 needle, 18-27g NF 1 0 CMS clinical review

L037

D RN/LPN/MTA NF Greet patient, provide gowning, assure appropriate medical records are available 3 1 CMS clinical review

L037

D RN/LPN/MTA NF Provide preservice education/obtai n consent 2 1 CMS clinical review
L037

D RN/LPN/MTA NF Prepare room, equipment, supplies 2 1 CMS clinical review
L037

D RN/LPN/MTA NF Clean room/equipment by physician staff 3 1 CMS clinical review
SJ02

8 hydrogen peroxide NF 10 0 CMS clinical review 11719 Trim nail(s) any number

SJ05 3 swab-pad, alcohol NF 10 0 CMS clinical review

13100 Cmplx rpr trunk 1.1-

2.5 cm EF01 4 light, surgical NF 32 27 Refined equipment time to reflect typical use exclusive to patient602

CPT Code CPT Code Description CMS Code CMS Code Description NonFac / Fac Labor Activity (if applicable) AMA RUC Recomme ndation or

Current

Value (min or

qty) CMS Refine ment (min or qty) Comment

EF01

5 mayo stand NF 32 39 Refined equipment time to reflect typical use exclusive to patient

EF02

3 table, exam NF 32 27 Refined equipment time to reflect typical use exclusive to patient

EF03

1 table, power NF 32 39 Refined equipment time to reflect typical use exclusive to patient

EQ1

14 electrosurgical generator, up to 120 watts NF 32 39 Refined equipment time to reflect typical use exclusive to patient

EQ1

37 instrument pack, basic ($500- $1499) NF 32 46 Refined equipment time to reflect typical use exclusive to patient

EQ3

51 Smoke Evacuator(tubing,

covering, etc.)

with stand NF 32 39 Refined equipment time to reflect typical use exclusive to patient603

CPT Code CPT Code Description CMS Code CMS Code Description NonFac / Fac Labor Activity (if applicable) AMA RUC Recomme ndation or

Current

Value (min or

qty) CMS Refine ment (min or qty) Comment

SB01

6 drape-cover, sterile, OR light handle NF 2 1 CMS clinical review SB02

7 gown, staff, impervious NF 2 0 Duplicativ e SB03

4 mask, surgical, with face shield NF 2 1 Duplicativ e SC02

9 needle, 18-27g NF 1 0 CMS clinical review SF01

6 cautery, monopolar, electrode tip NF 1 0 CMS clinical review SJ04

1 povidone soln (Betadine) NF 5 0 Duplicativ e

EF01

4 light, surgical NF 45 27 Refined equipment time to reflect typical use exclusive to patient

EF01

5 mayo stand NF 45 47 Refined equipment time to reflect typical use exclusive to patient

EF02

3 table, exam NF 45 27 Refined equipment time to reflect typical use exclusive to patient 13101 Cmplx rpr trunk 2.6-

7.5 cm

EF03 1 table, power NF 45 47 Refined equipment time to reflect typical use exclusive to patient604

CPT Code CPT Code Description CMS Code CMS Code Description NonFac / Fac Labor Activity (if applicable) AMA RUC Recomme ndation or

Current

Value (min or

qty) CMS Refine ment (min or qty) Comment

EQ1

14 electrosurgical generator, up to 120 watts NF 45 47 Refined equipment time to reflect typical use exclusive to patient

EQ1

37 instrument pack, basic ($500- $1499) NF 45 54 Refined equipment time to reflect typical use exclusive to patient EQ3

51 Smoke Evacuator(tubing,

covering, etc.)

with stand NF 45 47 CMS clinical review
SB01

6 drape-cover, sterile, OR light handle NF 2 1 CMS clinical review SB02

7 gown, staff, impervious NF 2 0 Duplicativ e SB02

7 gown, staff, impervious F 2 0 CMS clinical review SB03

4 mask, surgical, with face shield NF 2 1 Duplicativ e SB03

4 mask, surgical, with face shield F 2 1 CMS clinical review SC02

9 needle, 18-27g NF 1 0 CMS clinical review SF01

6 cautery, monopolar, electrode tip NF 1 0 CMS clinical review SJ04

1 povidone soln (Betadine) NF 10 0 Duplicativ e

13102 Cmplx rpr trunk addl

5cm/< EF01 5 mayo stand NF 30 20 Refined equipment time to reflect typical use exclusive to patient605

CPT Code CPT Code Description CMS Code CMS Code Description NonFac / Fac Labor Activity (if applicable) AMA RUC Recomme ndation or

Current

Value (min or

qty) CMS Refine ment (min or qty) Comment

EF03

1 table, power NF 30 20 Refined equipment time to reflect typical use exclusive to patient

EQ1

14 electrosurgical generator, up to 120 watts NF 30 20 Refined equipment time to reflect typical use exclusive to patient

EQ1

37 instrument pack, basic ($500- $1499) NF 30 20 Refined equipment time to reflect typical use exclusive to patient

EQ3

51 Smoke Evacuator(tubing,

covering, etc.)

with stand NF 30 20 Refined equipment time to reflect typical use exclusive to patient SF01

6 cautery, monopolar, electrode tip NF 1 0 CMS clinical review SJ04

1 povidone soln (Betadine) NF 5 0 Duplicativ e

13120 Cmplx rpr s/a/l 1.1-2.5 cm EF01 4 light, surgical NF 86 27 Refined equipment time to reflect typical use exclusive to patient606

CPT Code CPT Code Description CMS Code CMS Code Description NonFac / Fac Labor Activity (if applicable) AMA RUC Recomme ndation or

Current

Value (min or

qty) CMS Refine ment (min or qty) Comment

EF01

5 mayo stand NF 86 41 Refined equipment time to reflect typical use exclusive to patient

EF02

3 table, exam NF 86 27 Refined equipment time to reflect typical use exclusive to patient

EF03

1 table, power NF 86 41 Refined equipment time to reflect typical use exclusive to patient

EQ1

14 electrosurgical generator, up to 120 watts NF 86 41 Refined equipment time to reflect typical use exclusive to patient

EQ1

37 instrument pack, basic ($500- $1499) NF 86 48 Refined equipment time to reflect typical use exclusive to patient

EQ3

51 Smoke Evacuator(tubing,

covering, etc.)

with stand NF 86 41 Refined equipment time to reflect typical use exclusive to patient607

CPT Code CPT Code Description CMS Code CMS Code Description NonFac / Fac Labor Activity (if applicable) AMA RUC Recomme ndation or

Current

Value (min or

qty) CMS Refine ment (min or qty) Comment

SB01

6 drape-cover, sterile, OR light handle NF 2 1 CMS clinical review SB02

7 gown, staff, impervious NF 2 0 Duplicativ e SB02

7 gown, staff, impervious F 2 0 CMS clinical review SB03

4 mask, surgical, with face shield NF 2 1 Duplicativ e SB03

4 mask, surgical, with face shield F 2 1 CMS clinical review SC02

9 needle, 18-27g NF 1 0 CMS clinical review SF01

6 cautery, monopolar, electrode tip NF 1 0 CMS clinical review SJ04

1 povidone soln (Betadine) NF 5 0 Duplicativ e

EF01

4 light, surgical NF 129 27 Refined equipment time to reflect typical use exclusive to patient

EF01

5 mayo stand NF 129 48 Refined equipment time to reflect typical use exclusive to patient 13121 Cmplx rpr s/a/l 2.6-7.5 cm

EF02 3 table, exam NF 129 27 Refined equipment time to reflect typical use exclusive to patient608

CPT Code CPT Code Description CMS Code CMS Code Description NonFac / Fac Labor Activity (if applicable) AMA RUC Recomme ndation or

Current

Value (min or

qty) CMS Refine ment (min or qty) Comment

EF03

1 table, power NF 129 48 Refined equipment time to reflect typical use exclusive to patient

EQ1

14 electrosurgical generator, up to 120 watts NF 129 48 Refined equipment time to reflect typical use exclusive to patient

EQ1

37 instrument pack, basic ($500- $1499) NF 129 55 Refined equipment time to reflect typical use exclusive to patient

EQ3

51 Smoke Evacuator(tubing,

covering, etc.)

with stand NF 129 48 Refined equipment time to reflect typical use exclusive to patient L037

D RN/LPN/MTA NF Clean Surgical Instrument Package 15 10 Standardi zed time input SB01

6 drape-cover, sterile, OR light handle NF 2 1 CMS clinical review SB02

7 gown, staff, impervious NF 2 0 Duplicativ e SB03

4 mask, surgical, with face shield NF 2 1 Duplicativ e SC02

9 needle, 18-27g NF 1 0 CMS clinical review SF01

6 cautery, monopolar, electrode tip NF 1 0 CMS clinical review609

CPT Code CPT Code Description CMS Code CMS Code Description NonFac / Fac Labor Activity (if applicable) AMA RUC Recomme ndation or

Current

Value (min or

qty) CMS Refine ment (min or qty) Comment

SJ04

1 povidone soln (Betadine) NF 10 0 Duplicativ e

EF01

5 mayo stand NF 30 20 Refined equipment time to reflect typical use exclusive to patient

EF03

1 table, power NF 30 20 Refined equipment time to reflect typical use exclusive to patient

EQ1

14 electrosurgical generator, up to 120 watts NF 30 20 Refined equipment time to reflect typical use exclusive to patient

EQ1

37 instrument pack, basic ($500- $1499) NF 30 20 Refined equipment time to reflect typical use exclusive to patient

EQ3

51 Smoke Evacuator(tubing,

covering, etc.)

with stand NF 30 20 Refined equipment time to reflect typical use exclusive to patient SF01

6 cautery, monopolar, electrode tip NF 1 0 CMS clinical review 13122 Cmplx rpr s/a/l addl 5 cm/>

SJ04 1 povidone soln (Betadine) NF 5 0 Duplicativ e610

CPT Code CPT Code Description CMS Code CMS Code Description NonFac / Fac Labor Activity (if applicable) AMA RUC Recomme ndation or

Current

Value (min or

qty) CMS Refine ment (min or qty) Comment

EF01

4 light, surgical NF 45 27 Refined equipment time to reflect typical use exclusive to patient

EF01

5 mayo stand NF 45 48 Refined equipment time to reflect typical use exclusive to patient

EF02

3 table, exam NF 45 27 Refined equipment time to reflect typical use exclusive to patient

EF03

1 table, power NF 45 48 Refined equipment time to reflect typical use exclusive to patient

EQ1

14 electrosurgical generator, up to 120 watts NF 45 48 Refined equipment time to reflect typical use exclusive to patient 13131 Cmplx rpr f/c/c/m/n/ax /g/h/f

EQ1 37 instrument pack, basic ($500- $1499) NF 45 55 Refined equipment time to reflect typical use exclusive to patient611

CPT Code CPT Code Description CMS Code CMS Code Description NonFac / Fac Labor Activity (if applicable) AMA RUC Recomme ndation or

Current

Value (min or

qty) CMS Refine ment (min or qty) Comment

EQ3

51 Smoke Evacuator(tubing,

covering, etc.)

with stand NF 45 48 Refined equipment time to reflect typical use exclusive to patient SB01

6 drape-cover, sterile, OR light handle NF 2 1 CMS clinical review SB02

7 gown, staff, impervious NF 2 0 Duplicativ e SB03

4 mask, surgical, with face shield NF 2 1 Duplicativ e SC02

9 needle, 18-27g NF 1 0 CMS clinical review SF01

6 cautery, monopolar, electrode tip NF 1 0 CMS clinical review SJ04

1 povidone soln (Betadine) NF 5 0 Duplicativ e

EF01

4 light, surgical NF 50 27 Refined equipment time to reflect typical use exclusive to patient

EF01

5 mayo stand NF 50 51 Refined equipment time to reflect typical use exclusive to patient 13132 Cmplx rpr f/c/c/m/n/ax /g/h/f

EF02 3 table, exam NF 50 27 Refined equipment time to reflect typical use exclusive to patient612

CPT Code CPT Code Description CMS Code CMS Code Description NonFac / Fac Labor Activity (if applicable) AMA RUC Recomme ndation or

Current

Value (min or

qty) CMS Refine ment (min or qty) Comment

EF03

1 table, power NF 50 51 Refined equipment time to reflect typical use exclusive to patient

EQ1

14 electrosurgical generator, up to 120 watts NF 50 51 Refined equipment time to reflect typical use exclusive to patient

EQ1

37 instrument pack, basic ($500- $1499) NF 50 58 Refined equipment time to reflect typical use exclusive to patient

EQ3

51 Smoke Evacuator(tubing,

covering, etc.)

with stand NF 50 51 Refined equipment time to reflect typical use exclusive to patient SB01

6 drape-cover, sterile, OR light handle NF 2 1 CMS clinical review SB02

7 gown, staff, impervious NF 2 0 Duplicativ e SB03

4 mask, surgical, with face shield NF 2 1 Duplicativ e SC02

9 needle, 18-27g NF 1 0 CMS clinical review SF01

6 cautery, monopolar, electrode tip NF 1 0 CMS clinical review SJ04

1 povidone soln (Betadine) NF 10 0 Duplicativ e613

CPT Code CPT Code Description CMS Code CMS Code Description NonFac / Fac Labor Activity (if applicable) AMA RUC Recomme ndation or

Current

Value (min or

qty) CMS Refine ment (min or qty) Comment

EF01

5 mayo stand NF 35 23 Refined equipment time to reflect typical use exclusive to patient

EF03

1 table, power NF 35 23 Refined equipment time to reflect typical use exclusive to patient

EQ1

14 electrosurgical generator, up to 120 watts NF 35 23 Refined equipment time to reflect typical use exclusive to patient

EQ1

37 instrument pack, basic ($500- $1499) NF 35 23 Refined equipment time to reflect typical use exclusive to patient

EQ3

51 Smoke Evacuator(tubing,

covering, etc.)

with stand NF 35 23 Refined equipment time to reflect typical use exclusive to patient SF01

6 cautery, monopolar, electrode tip NF 1 0 CMS clinical review 13133 Cmplx rpr f/c/c/m/n/ax /g/h/f

SJ04 1 povidone soln (Betadine) NF 5 0 Duplicativ e614

CPT Code CPT Code Description CMS Code CMS Code Description NonFac / Fac Labor Activity (if applicable) AMA RUC Recomme ndation or

Current

Value (min or

qty) CMS Refine ment (min or qty) Comment

EF01

4 light, surgical NF 30 27 Refined equipment time to reflect typical use exclusive to patient

EF01

5 mayo stand NF 30 44 Refined equipment time to reflect typical use exclusive to patient

EF02

3 table, exam NF 30 27 Refined equipment time to reflect typical use exclusive to patient

EF03

1 table, power NF 30 44 Refined equipment time to reflect typical use exclusive to patient

EQ1

14 electrosurgical generator, up to 120 watts NF 30 44 Refined equipment time to reflect typical use exclusive to patient 13150 Cmplx rpr e/n/e/l 1.0

cm/<

EQ1 37 instrument pack, basic ($500- $1499) NF 30 51 Refined equipment time to reflect typical use exclusive to patient615

CPT Code CPT Code Description CMS Code CMS Code Description NonFac / Fac Labor Activity (if applicable) AMA RUC Recomme ndation or

Current

Value (min or

qty) CMS Refine ment (min or qty) Comment

EQ3

51 Smoke Evacuator(tubing,

covering, etc.)

with stand NF 30 44 Refined equipment time to reflect typical use exclusive to patient
L037

D RN/LPN/MTA NF Assist physician in performing procedure 20 26 Conformi ng to physician time SB01

6 drape-cover, sterile, OR light handle NF 2 1 CMS clinical review SB02

7 gown, staff, impervious NF 2 0 Duplicativ e SB03

4 mask, surgical, with face shield NF 2 1 Duplicativ e SC02

9 needle, 18-27g NF 1 0 CMS clinical review SF01

6 cautery, monopolar, electrode tip NF 1 0 CMS clinical review SJ04

1 povidone soln (Betadine) NF 5 0 Duplicativ e

EF01

4 light, surgical NF 45 27 Refined equipment time to reflect typical use exclusive to patient 13151 Cmplx rpr e/n/e/l 1.1-

2.5 cm

EF01 5 mayo stand NF 45 48 Refined equipment time to reflect typical use exclusive to patient616

CPT Code CPT Code Description CMS Code CMS Code Description NonFac / Fac Labor Activity (if applicable) AMA RUC Recomme ndation or

Current

Value (min or

qty) CMS Refine ment (min or qty) Comment

EF02

3 table, exam NF 45 27 Refined equipment time to reflect typical use exclusive to patient

EF03

1 table, power NF 45 48 Refined equipment time to reflect typical use exclusive to patient

EQ1

14 electrosurgical generator, up to 120 watts NF 45 48 Refined equipment time to reflect typical use exclusive to patient

EQ1

37 instrument pack, basic ($500- $1499) NF 45 55 Refined equipment time to reflect typical use exclusive to patient

EQ3

51 Smoke Evacuator(tubing,

covering, etc.)

with stand NF 45 48 Refined equipment time to reflect typical use exclusive to patient SB01

6 drape-cover, sterile, OR light handle NF 2 1 CMS clinical review SB02

7 gown, staff, impervious NF 2 0 Duplicativ e SB03

4 mask, surgical, with face shield NF 2 1 Duplicativ e617

CPT Code CPT Code Description CMS Code CMS Code Description NonFac / Fac Labor Activity (if applicable) AMA RUC Recomme ndation or

Current

Value (min or

qty) CMS Refine ment (min or qty) Comment

SC02

9 needle, 18-27g NF 1 0 CMS clinical review SF01

6 cautery, monopolar, electrode tip NF 1 0 CMS clinical review SJ04

1 povidone soln (Betadine) NF 5 0 Duplicativ e

EF01

4 light, surgical NF 50 27 Refined equipment time to reflect typical use exclusive to patient

EF01

5 mayo stand NF 50 51 Refined equipment time to reflect typical use exclusive to patient

EF02

3 table, exam NF 50 27 Refined equipment time to reflect typical use exclusive to patient

EF03

1 table, power NF 50 51 Refined equipment time to reflect typical use exclusive to patient 13152 Cmplx rpr e/n/e/l 2.6-

7.5 cm

EQ1 14 electrosurgical generator, up to 120 watts NF 50 51 Refined equipment time to reflect typical use exclusive to patient618

CPT Code CPT Code Description CMS Code CMS Code Description NonFac / Fac Labor Activity (if applicable) AMA RUC Recomme ndation or

Current

Value (min or

qty) CMS Refine ment (min or qty) Comment

EQ1

37 instrument pack, basic ($500- $1499) NF 50 58 Refined equipment time to reflect typical use exclusive to patient

EQ3

51 Smoke Evacuator(tubing,

covering, etc.)

with stand NF 50 51 Refined equipment time to reflect typical use exclusive to patient L037

D RN/LPN/MTA NF 15 10 Standardi zed time input SB01

6 drape-cover, sterile, OR light handle NF 2 1 CMS clinical review SB02

7 gown, staff, impervious NF 2 0 Duplicativ e SB03

4 mask, surgical, with face shield NF 2 1 Duplicativ e SF01

6 cautery, monopolar, electrode tip NF 1 0 CMS clinical review SJ04

1 povidone soln (Betadine) NF 10 0 Duplicativ e

EF01

5 mayo stand NF 45 30 Refined equipment time to reflect typical use exclusive to patient 13153 Cmplx rpr e/n/e/l addl

5cm/<

EF03 1 table, power NF 45 30 Refined equipment time to reflect typical use exclusive to patient619

CPT Code CPT Code Description CMS Code CMS Code Description NonFac / Fac Labor Activity (if applicable) AMA RUC Recomme ndation or

Current

Value (min or

qty) CMS Refine ment (min or qty) Comment

EQ1

14 electrosurgical generator, up to 120 watts NF 45 30 Refined equipment time to reflect typical use exclusive to patient

EQ1

37 instrument pack, basic ($500- $1499) NF 45 30 Refined equipment time to reflect typical use exclusive to patient

EQ3

51 Smoke Evacuator(tubing,

covering, etc.)

with stand NF 45 30 Refined equipment time to reflect typical use exclusive to patient SC02

9 needle, 18-27g NF 2 0 CMS clinical review SF01

6 cautery, monopolar, electrode tip NF 1 0 CMS clinical review SJ04

1 povidone soln (Betadine) NF 5 0 Duplicativ e

EF02

3 table, exam NF 19 16 Refined equipment time to reflect typical use exclusive to patient 20600 Drain/inject joint/bursa

EQ1 68 light, exam NF 19 16 Refined equipment time to reflect typical use exclusive to patient620

CPT Code CPT Code Description CMS Code CMS Code Description NonFac / Fac Labor Activity (if applicable) AMA RUC Recomme ndation or

Current

Value (min or

qty) CMS Refine ment (min or qty) Comment

L037

D RN/LPN/MTA F Discharge day management 6 0 CMS clinical review L037

D RN/LPN/MTA F Conduct phone calls/call in prescriptions 0 3 CMS clinical review SC02

9 needle, 18-27g NF 4 2 CMS clinical review SC05

5 syringe 3ml NF 2 1 CMS clinical review

EF02

3 table, exam NF 19 16 Refined equipment time to reflect typical use exclusive to patient

EQ1

68 light, exam NF 19 16 Refined equipment time to reflect typical use exclusive to patient L037

D RN/LPN/MTA F Discharge day management 6 0 CMS clinical review L037

D RN/LPN/MTA F Conduct phone calls/call in prescriptions 0 3 CMS clinical review SC02

9 needle, 18-27g NF 4 2 CMS clinical review 20605 Drain/inject joint/bursa

SC05 5 syringe 3ml NF 2 1 CMS clinical review

20610 Drain/inject joint/bursa EF02 3 table, exam NF 19 16 Refined equipment time to reflect typical use exclusive to patient621

CPT Code CPT Code Description CMS Code CMS Code Description NonFac / Fac Labor Activity (if applicable) AMA RUC Recomme ndation or

Current

Value (min or

qty) CMS Refine ment (min or qty) Comment

EQ1

68 light, exam NF 19 16 Refined equipment time to reflect typical use exclusive to patient L037

D RN/LPN/MTA F Discharge day management 6 0 CMS clinical review L037

D RN/LPN/MTA F Conduct phone calls/call in prescriptions 0 3 CMS clinical review SC02

9 needle, 18-27g NF 4 2 CMS clinical review SC05

7 syringe 5-6ml NF 2 1 CMS clinical review SA05

2 pack, post-op incision care (staple) F 0 1 CMS clinical review 23472 Reconstruct shoulder

joint SA05 3 pack, post-op incision care (suture & staple) F 1 0 CMS clinical review SA05

2 pack, post-op incision care (staple) F 0 1 CMS clinical review 23473 Revis reconst shoulder

joint SA05 3 pack, post-op incision care (suture & staple) F 1 0 CMS clinical review SA05

2 pack, post-op incision care (staple) F 0 1 CMS clinical review 23474 Revis reconst shoulder

joint SA05 3 pack, post-op incision care (suture & staple) F 1 0 CMS clinical review SA05

2 pack, post-op incision care (staple) F 0 1 CMS clinical review 24363 Replace elbow joint SA05 3 pack, post-op incision care (suture & staple) F 1 0 CMS clinical review
24370 Revise reconst elbow joint SA05 2 pack, post-op incision care (staple) F 0 1 CMS clinical review622

CPT Code CPT Code Description CMS Code CMS Code Description NonFac / Fac Labor Activity (if applicable) AMA RUC Recomme ndation or

Current

Value (min or

qty) CMS Refine ment (min or qty) Comment

SA05

2 pack, post-op incision care (staple) F 0 1 CMS clinical review SA05

3 pack, post-op incision care (suture & staple) F 1 0 CMS clinical review SA05

3 pack, post-op incision care (suture & staple) F 1 0 CMS clinical review

EF00

8 chair with headrest, exam, reclining NF 43 35 Refined equipment time to reflect typical use exclusive to patient

EQ1

38 instrument pack, medium ($1500 and up) NF 0 47 Refined equipment time to reflect typical use exclusive to patient

EQ1

67 light source, xenon NF 43 35 Refined equipment time to reflect typical use exclusive to patient

EQ1

70 light, fiberopticheadlight wsource NF 43 35 Refined equipment time to reflect typical use exclusive to patient 31231 Nasal endoscopy dx

EQ2 34 suction and pressure cabinet,

ENT (SMR) NF 43 35 Refined equipment time to reflect typical use exclusive to patient623

CPT Code CPT Code Description CMS Code CMS Code Description NonFac / Fac Labor Activity (if applicable) AMA RUC Recomme ndation or

Current

Value (min or

qty) CMS Refine ment (min or qty) Comment

ES01

3 endoscope, rigid, sinoscopy NF 63 42 Refined equipment time to reflect typical use exclusive to patient ES01

3 endoscope, rigid, sinoscopy NF 63 0 CMS clinical review

ES03

1 video system, endoscopy (processor, digital capture, monitor,

printer, cart) NF 43 35 Refined equipment time to reflect typical use exclusive to patient

ES03

2 video system, stroboscopy

(strobing platform, camera, digital recorder, monitor, printer, cart) NF 43 35 Refined equipment time to reflect typical use exclusive to patient

ES03

6 Nasal Endoscopy Instrument

Package NF 63 0 Nonstandard direct practice expense input

L037

D RN/LPN/MTA NF Greet patient, provide gowning, assure appropriate medical records are available 2 0 CMS clinical review

L037

D RN/LPN/MTA NF Obtain vital signs 1 0 CMS clinical review L037

D RN/LPN/MTA NF Clean Surgical Instrument Package 10 15 Standardi zed time input
L037

D RN/LPN/MTA NF Review/read Xray, lab, and pathology reports 5 0 CMS clinical review624

CPT Code CPT Code Description CMS Code CMS Code Description NonFac / Fac Labor Activity (if applicable) AMA RUC Recomme ndation or

Current

Value (min or

qty) CMS Refine ment (min or qty) Comment

SB02

7 gown, staff, impervious NF 2 1 Duplicativ e SB03

4 mask, surgical, with face shield NF 2 1 Duplicativ e L047

C RN/Respiratory Therapist F Complete preservice diagnostic & referral forms 3 5 CMS clinical review 31647 Bronchial valve init

insert L047 C RN/Respiratory Therapist F Coordinate presurgery services 5 3 CMS clinical review

EF02

3 table, exam NF 56 52 Refined equipment time to reflect typical use exclusive to patient

EQ1

68 light, exam NF 0 52 Refined equipment time to reflect typical use exclusive to patient
L037

D RN/LPN/MTA NF Complete preservice diagnostic & referral forms 5 0 CMS clinical review
L037

D RN/LPN/MTA NF Coordinate presurgery services 3 1 CMS clinical review

L037

D RN/LPN/MTA NF Monitor pt. following service/check tubes, monitors, drains 5 10 CMS clinical review

SA04

8 pack, minimum multi-specialty visit NF 0 1 CMS clinical review SA06

7 tray, shave prep NF 0 1 CMS clinical review 32554 Aspirate pleura w/o

imaging

SA07 7 kit, pleural catheter insertion NF 0 1 CMS clinical review625

CPT Code CPT Code Description CMS Code CMS Code Description NonFac / Fac Labor Activity (if applicable) AMA RUC Recomme ndation or

Current

Value (min or

qty) CMS Refine ment (min or qty) Comment

SB00

1 cap, surgical NF 0 2 CMS clinical review SB00

6 drape, non-sterile, sheet 40in x 60in NF 1 0 CMS clinical review SB02

4 gloves, sterile NF 1 2 CMS clinical review SB03

4 mask, surgical, with face shield NF 0 2 CMS clinical review SB03

9 shoe covers, surgical NF 0 2 CMS clinical review SB04

4 underpad 2ft x 3ft (Chux) NF 0 1 CMS clinical review SG05

6 gauze, sterile 4in x 4in (10 pack uou) NF 0 1 CMS clinical review

ED0

24 film processor, dry, laser NF 58 7 Refined equipment time to reflect typical use exclusive to patient EF01

9 stretcher chair NF 15 10 CMS clinical review

EL01

5 room, ultrasound, general NF 33 35 Refined equipment time to reflect typical use exclusive to patient 32555 Aspirate pleura w/ imaging

ER02 9 film alternator (motorized film viewbox) NF 58 7 Refined equipment time to reflect typical use exclusive to patient626

CPT Code CPT Code Description CMS Code CMS Code Description NonFac / Fac Labor Activity (if applicable) AMA RUC Recomme ndation or

Current

Value (min or

qty) CMS Refine ment (min or qty) Comment

L037

D RN/LPN/MTA NF Complete preservice diagnostic & referral forms 5 0 CMS clinical review
L037

D RN/LPN/MTA NF Coordinate presurgery services 3 1 CMS clinical review

L037

D RN/LPN/MTA NF Monitor pt. following service/check tubes, monitors, drains 15 10 CMS clinical review

L037

D RN/LPN/MTA NF Process images, complete data sheet, present images and data to the interpreting physician 5 2 CMS clinical review

SA02

7 kit, scissors and clamp NF 0 1 CMS clinical review SA07

7 kit, pleural catheter insertion NF 0 1 CMS clinical review SB00

1 cap, surgical NF 0 3 CMS clinical review SB02

7 gown, staff, impervious NF 0 1 CMS clinical review SB03

9 shoe covers, surgical NF 0 3 CMS clinical review SB04

4 underpad 2ft x 3ft (Chux) NF 0 1 CMS clinical review SG07

8 tape, surgical occlusive 1in (Blenderm) NF 0 15 CMS clinical review SM0

12 disinfectant spray (Transeptic) NF 10 0 CMS clinical review SM0

21 sanitizing clothwipe (patient) NF 2 0 CMS clinical review627

CPT Code CPT Code Description CMS Code CMS Code Description NonFac / Fac Labor Activity (if applicable) AMA RUC Recomme ndation or

Current

Value (min or

qty) CMS Refine ment (min or qty) Comment

EQ1

68 light, exam NF 0 76 Refined equipment time to reflect typical use exclusive to patient
L037

D RN/LPN/MTA NF Complete preservice diagnostic & referral forms 5 0 CMS clinical review
L037

D RN/LPN/MTA NF Coordinate presurgery services 3 1 CMS clinical review SA04

4 pack, moderate sedation NF 0 1 CMS clinical review SA04

8 pack, minimum multi-specialty visit NF 0 1 CMS clinical review SA06

7 tray, shave prep NF 0 1 CMS clinical review SB00

1 cap, surgical NF 0 2 CMS clinical review SB00

6 drape, non-sterile, sheet 40in x 60in NF 1 0 CMS clinical review SB03

4 mask, surgical, with face shield NF 0 2 CMS clinical review SB03

9 shoe covers, surgical NF 0 2 CMS clinical review SB04

4 underpad 2ft x 3ft (Chux) NF 0 1 CMS clinical review SC01

0 closed flush system, angiography NF 0 1 CMS clinical review SG05

6 gauze, sterile 4in x 4in (10 pack uou) NF 1 0 CMS clinical review 32556 Insert cath pleura w/o

image

SH06 5 sodium chloride 0.9% flush

syringe NF 0 1 CMS clinical review628

CPT Code CPT Code Description CMS Code CMS Code Description NonFac / Fac Labor Activity (if applicable) AMA RUC Recomme ndation or

Current

Value (min or

qty) CMS Refine ment (min or qty) Comment

SH06

9 sodium chloride 0.9% irrigation (500-1000ml uou) NF 0 1 CMS clinical review
SL15

7 cup, sterile, 8 oz NF 0 1 CMS clinical review ED0

24 film processor, dry, laser NF 58 7 CMS clinical review EF01

9 stretcher chair NF 15 10 CMS clinical review

EL00

7 room, CT NF 43 40 Refined equipment time to reflect typical use exclusive to patient

EQ1

68 light, exam NF 60 40 Refined equipment time to reflect typical use exclusive to patient ER02

9 film alternator (motorized film viewbox) NF 58 7 CMS clinical review
L037

D RN/LPN/MTA NF Complete preservice diagnostic & referral forms 5 0 CMS clinical review
L037

D RN/LPN/MTA NF Coordinate presurgery services 3 1 CMS clinical review

L037

D RN/LPN/MTA NF Check dressings & wound/ home care instructions /coordinate office visits /prescriptions 3 5 CMS clinical review 32557 Insert cath pleura w/

image

L046 A CT Technologist NF Assist physician in performing procedure 28 30 Conformi ng to physician time629

CPT Code CPT Code Description CMS Code CMS Code Description NonFac / Fac Labor Activity (if applicable) AMA RUC Recomme ndation or

Current

Value (min or

qty) CMS Refine ment (min or qty) Comment

SA04

4 pack, moderate sedation NF 0 1 CMS clinical review
SA07

1 kit, AccuStick II Introducer System with RO Marker NF 1 0 CMS clinical review
SA07

7 kit, pleural catheter insertion NF 0 1 CMS clinical review SB00

1 cap, surgical NF 2 3 CMS clinical review SB01

1 drape, sterile, fenestrated 16in x 29in NF 1 0 CMS clinical review SB01

4 drape, sterile, three-quarter sheet NF 1 0 CMS clinical review SB01

9 drape-towel, sterile 18in x 26in NF 4 0 CMS clinical review SB02

4 gloves, sterile NF 2 1 CMS clinical review SB02

7 gown, staff, impervious NF 0 1 CMS clinical review SB03

9 shoe covers, surgical NF 2 3 CMS clinical review SC04

9 stop cock, 3-way NF 1 0 CMS clinical review SC05

6 syringe 50-60ml NF 2 0 CMS clinical review
SC05

8 syringe w-needle, OSHA compliant

(SafetyGlide) NF 1 0 CMS clinical review
SD04

3 dilator, vessel, angiographic NF 1 0 CMS clinical review SD08

8 guidewire NF 1 0 CMS clinical review630

CPT Code CPT Code Description CMS Code CMS Code Description NonFac / Fac Labor Activity (if applicable) AMA RUC Recomme ndation or

Current

Value (min or

qty) CMS Refine ment (min or qty) Comment

SD14

6 catheter percutaneousfastener (PercuStay) NF 1 0 CMS clinical review
SD16

1 drainage catheter, all purpose NF 1 0 CMS clinical review SD16

3 drainage pouch,nephrostomybiliary NF 1 0 CMS clinical review SF00

7 blade, surgical (Bard-Parker) NF 1 0 CMS clinical review SG00

9 applicator, sponge-tipped NF 4 0 CMS clinical review SG07

8 tape, surgical occlusive 1in (Blenderm) NF 0 25 CMS clinical review SH04

7 lidocaine 1%-2% inj (Xylocaine) NF 10 0 CMS clinical review SJ04

1 povidone soln (Betadine) NF 60 0 CMS clinical review SL03

6 cup, biopsyspecimen sterile 4oz NF 1 0 CMS clinical review SL15

6 cup, sterile, 12-16 oz NF 1 0 CMS clinical review L037

D RN/LPN/MTA F Coordinate presurgery services 40 10 Standardi zed time input L037

D RN/LPN/MTA F Schedule space and equipment in facility 8 5 Standardi zed time input
L037

D RN/LPN/MTA F Provide preservice education/obtai n consent 20 7 Standardi zed time input 33361 Replace aortic valve perq

L037 D RN/LPN/MTA F Follow-up phone calls & prescriptions 7 3 Standardi zed time input
33362 Replace aortic valve open L037 D RN/LPN/MTA F Coordinate presurgery services 40 10 Standardi zed time input631

CPT Code CPT Code Description CMS Code CMS Code Description NonFac / Fac Labor Activity (if applicable) AMA RUC Recomme ndation or

Current

Value (min or

qty) CMS Refine ment (min or qty) Comment

L037

D RN/LPN/MTA F Schedule space and equipment in facility 8 5 Standardi zed time input
L037

D RN/LPN/MTA F Provide preservice education/obtai n consent 20 7 Standardi zed time input
L037

D RN/LPN/MTA F Follow-up phone calls & prescriptions 7 3 Standardi zed time input L037

D RN/LPN/MTA F Coordinate presurgery services 40 10 Standardi zed time input L037

D RN/LPN/MTA F Schedule space and equipment in facility 8 5 Standardi zed time input
L037

D RN/LPN/MTA F Provide preservice education/obtai n consent 20 7 Standardi zed time input 33363 Replace aortic valve open

L037 D RN/LPN/MTA F Follow-up phone calls & prescriptions 7 3 Standardi zed time input L037

D RN/LPN/MTA F Coordinate presurgery services 40 10 Standardi zed time input L037

D RN/LPN/MTA F Schedule space and equipment in facility 8 5 Standardi zed time input
L037

D RN/LPN/MTA F Provide preservice education/obtai n consent 20 7 Standardi zed time input 33364 Replace aortic valve open

L037 D RN/LPN/MTA F Follow-up phone calls & prescriptions 7 3 Standardi zed time input L037

D RN/LPN/MTA F Coordinate presurgery services 40 10 Standardi zed time input L037

D RN/LPN/MTA F Schedule space and equipment in facility 8 5 Standardi zed time input
L037

D RN/LPN/MTA F Provide preservice education/obtai n consent 20 7 Standardi zed time input 33365 Replace aortic valve open

L037 D RN/LPN/MTA F Follow-up phone calls & prescriptions 7 3 Standardi zed time input632

CPT Code CPT Code Description CMS Code CMS Code Description NonFac / Fac Labor Activity (if applicable) AMA RUC Recomme ndation or

Current

Value (min or

qty) CMS Refine ment (min or qty) Comment

L051

A RN F Other Clinical Activity - specify: for reference code 33406 and codes 33405 and 33430: Additional coordination between multiple specialties for complex procedures (tests, meds, scheduling, etc) prior to patient arrival at site of service. 15 0 CMS clinical review

33405 Replacemen t of aortic

valve

L051 A RN F Other Clinical Activity - specify: for reference code 33406 and codes 33405 and 33430: Additional coordination between multiple specialties for complex procedures (tests, meds, scheduling, etc) prior to patient arrival at site of service. 15 0 CMS clinical review

35475 Repair arterial blockage EL01 1 room, angiography NF 51 52 Refined equipment time to reflect typical use exclusive to patient633

CPT Code CPT Code Description CMS Code CMS Code Description NonFac / Fac Labor Activity (if applicable) AMA RUC Recomme ndation or

Current

Value (min or

qty) CMS Refine ment (min or qty) Comment

EQ0

11 ECG, 3-channel (with SpO2, NIBP, temp, resp) NF 212 285 Moderate Sedation equipment - Time includes administer ing anesthesia

, procedure time, and monitorin g patient

EQ0

32 IV infusion pump NF 212 285 Moderate Sedation equipment - Time includes administer ing anesthesia

, procedure time, and monitorin g patient

EQ1

68 light, exam NF 120 52 Refined equipment time to reflect typical use exclusive to patient
L037

D RN/LPN/MTA F Complete preservice diagnostic & referral forms 5 3 CMS clinical review
L037

D RN/LPN/MTA NF Obtain vital signs 5 3 CMS clinical review L041

B Radiologic Technologist NF Prepare room, equipment, supplies 4 2 Standardi zed time input SB01

9 drape-towel, sterile 18in x 26in NF 4 2 CMS clinical review634

CPT Code CPT Code Description CMS Code CMS Code Description NonFac / Fac Labor Activity (if applicable) AMA RUC Recomme ndation or

Current

Value (min or

qty) CMS Refine ment (min or qty) Comment

Ef02

7 table, instrument, mobile NF 302 277 Moderate Sedation equipment - Time includes administer ing anesthesia

, procedure time, and monitorin g patient

EL01

1 room, angiography NF 43 44 Refined equipment time to reflect typical use exclusive to patient

EQ0

11 ECG, 3-channel (with SpO2, NIBP, temp, resp) NF 137 277 Moderate Sedation equipment - Time includes administer ing anesthesia

, procedure time, and monitorin g patient 35476 Repair venous blockage

EQ0 32 IV infusion pump NF 137 277 Moderate Sedation equipment - Time includes administer ing anesthesia

, procedure time, and monitorin g patient635

CPT Code CPT Code Description CMS Code CMS Code Description NonFac / Fac Labor Activity (if applicable) AMA RUC Recomme ndation or

Current

Value (min or

qty) CMS Refine ment (min or qty) Comment

EQ1

68 light, exam NF 120 44 Refined equipment time to reflect typical use exclusive to patient L037

D RN/LPN/MTA F Schedule space and equipment in facility 3 5 CMS clinical review L037

D RN/LPN/MTA NF Obtain vital signs 5 3 CMS clinical review L041

B Radiologic Technologist NF Prepare room, equipment, supplies 4 2 Standardi zed time input SB01

9 drape-towel, sterile 18in x 26in NF 4 2 CMS clinical review EF01

8 stretcher NF 272 0 CMS Code correction EF02

7 table, instrument, mobile NF 0 272 CMS Code correction

EL01

1 room, angiography NF 49 39 Refined equipment time to reflect typical use exclusive to patient 36221 Place cath thoracic

aorta

EQ0 88 contrast media warmer NF 49 39 Refined equipment time to reflect typical use exclusive to patient636

CPT Code CPT Code Description CMS Code CMS Code Description NonFac / Fac Labor Activity (if applicable) AMA RUC Recomme ndation or

Current

Value (min or

qty) CMS Refine ment (min or qty) Comment

ER02

9 film alternator (motorized film viewbox) NF 49 39 Refined equipment time to reflect typical use exclusive to patient

L037

D RN/LPN/MTA NF Greet patient, provide gowning, assure appropriate medical records are available 5 3 Standardi zed time input

L037

D RN/LPN/MTA NF Obtain vital signs 5 3 CMS clinical review L041

A Angio Technician NF Image Post Processing 5 0 CMS clinical review L041

B Radiologic Technologist NF Prepare room, equipment, supplies 2 7 CMS clinical review
L041

B Radiologic Technologist NF Prepare and position patient/ monitor patient/ set up IV 2 7 CMS clinical review

SD24

9 Sterile Radioopaque ruler (le Maitre, documentation

available) NF 1 0 CMS clinical review

EF01

8 stretcher NF 282 0 CMS Code correction EF02

7 table, instrument, mobile NF 0 282 CMS Code correction 36222 Place cath carotid/ino m art

EL01 1 room, angiography NF 59 49 Refined equipment time to reflect typical use exclusive to patient637

CPT Code CPT Code Description CMS Code CMS Code Description NonFac / Fac Labor Activity (if applicable) AMA RUC Recomme ndation or

Current

Value (min or

qty) CMS Refine ment (min or qty) Comment

EQ0

88 contrast media warmer NF 59 49 Refined equipment time to reflect typical use exclusive to patient

ER02

9 film alternator (motorized film viewbox) NF 59 49 Refined equipment time to reflect typical use exclusive to patient

L037

D RN/LPN/MTA NF Greet patient, provide gowning, assure appropriate medical records are available 5 3 Standardi zed time input

L037

D RN/LPN/MTA NF Obtain vital signs 5 3 CMS clinical review SD14

7 catheter, (Glide) NF 1 0 CMS clinical review

SD24

9 Sterile Radioopaque ruler (le Maitre, documentation

available) NF 1 0 CMS clinical review

EF01

8 stretcher NF 287 0 CMS Code correction EF02

7 table, instrument, mobile NF 0 287 CMS Code correction 36223 Place cath carotid/ino m art

EL01 1 room, angiography NF 64 54 Refined equipment time to reflect typical use exclusive to patient638

CPT Code CPT Code Description CMS Code CMS Code Description NonFac / Fac Labor Activity (if applicable) AMA RUC Recomme ndation or

Current

Value (min or

qty) CMS Refine ment (min or qty) Comment

EQ0

88 contrast media warmer NF 64 54 Refined equipment time to reflect typical use exclusive to patient

ER02

9 film alternator (motorized film viewbox) NF 64 54 Refined equipment time to reflect typical use exclusive to patient

L037

D RN/LPN/MTA NF Greet patient, provide gowning, assure appropriate medical records are available 5 3 Standardi zed time input

L037

D RN/LPN/MTA NF Obtain vital signs 5 3 CMS clinical review

SD24

9 Sterile Radioopaque ruler (le Maitre, documentation

available) NF 1 0 CMS clinical review

EF01

8 stretcher NF 292 0 CMS Code correction EF02

7 table, instrument, mobile NF 0 292 CMS Code correction 36224 Place cath carotd art

EL01 1 room, angiography NF 69 59 Refined equipment time to reflect typical use exclusive to patient639

CPT Code CPT Code Description CMS Code CMS Code Description NonFac / Fac Labor Activity (if applicable) AMA RUC Recomme ndation or

Current

Value (min or

qty) CMS Refine ment (min or qty) Comment

EQ0

88 contrast media warmer NF 69 59 Refined equipment time to reflect typical use exclusive to patient

ER02

9 film alternator (motorized film viewbox) NF 69 59 Refined equipment time to reflect typical use exclusive to patient

L037

D RN/LPN/MTA NF Greet patient, provide gowning, assure appropriate medical records are available 5 3 Standardi zed time input

L037

D RN/LPN/MTA NF Obtain vital signs 5 3 CMS clinical review EF01

8 stretcher NF 287 0 CMS Code correction EF02

7 table, instrument, mobile NF 0 287 CMS Code correction

EL01

1 room, angiography NF 64 54 Refined equipment time to reflect typical use exclusive to patient 36225 Place cath subclavian art

EQ0 88 contrast media warmer NF 64 54 Refined equipment time to reflect typical use exclusive to patient640

CPT Code CPT Code Description CMS Code CMS Code Description NonFac / Fac Labor Activity (if applicable) AMA RUC Recomme ndation or

Current

Value (min or

qty) CMS Refine ment (min or qty) Comment

ER02

9 film alternator (motorized film viewbox) NF 64 54 Refined equipment time to reflect typical use exclusive to patient

L037

D RN/LPN/MTA NF Greet patient, provide gowning, assure appropriate medical records are available 5 3 Standardi zed time input

L037

D RN/LPN/MTA NF Obtain vital signs 5 3 CMS clinical review EF01

8 stretcher NF 292 0 CMS Code correction EF02

7 table, instrument, mobile NF 0 292 CMS Code correction

EL01

1 room, angiography NF 69 59 Refined equipment time to reflect typical use exclusive to patient

EQ0

88 contrast media warmer NF 69 59 Refined equipment time to reflect typical use exclusive to patient 36226 Place cath vertebral art

ER02 9 film alternator (motorized film viewbox) NF 69 59 Refined equipment time to reflect typical use exclusive to patient641

CPT Code CPT Code Description CMS Code CMS Code Description NonFac / Fac Labor Activity (if applicable) AMA RUC Recomme ndation or

Current

Value (min or

qty) CMS Refine ment (min or qty) Comment

L037

D RN/LPN/MTA NF Greet patient, provide gowning, assure appropriate medical records are available 5 3 Standardi zed time input

L037

D RN/LPN/MTA NF Obtain vital signs 5 3 CMS clinical review L041

B Radiologic Technologist NF Prepare room, equipment, supplies 1 0 CMS clinical review
L041

B Radiologic Technologist NF Assisting with flouroscopy/ima ge acquisition (75%) 23 22 CMS clinical review 36228 Place cath intracranial art
SC05 7 syringe 5-6ml NF 4 0 CMS clinical review

EF02

7 table, instrument, mobile NF 305 302 Moderate Sedation equipment - Time includes administer ing anesthesia

, procedure time, and monitorin g patient 37197 Remove intrvas foreign

body

EL01 1 room, angiography NF 77 72 Refined equipment time to reflect typical use exclusive to patient642

CPT Code CPT Code Description CMS Code CMS Code Description NonFac / Fac Labor Activity (if applicable) AMA RUC Recomme ndation or

Current

Value (min or

qty) CMS Refine ment (min or qty) Comment

EQ0

11 ECG, 3-channel (with SpO2, NIBP, temp, resp) NF 305 302 Moderate Sedation equipment - Time includes administer ing anesthesia

, procedure time, and monitorin g patient

EQ0

32 IV infusion pump NF 305 302 Moderate Sedation equipment - Time includes administer ing anesthesia

, procedure time, and monitorin g patient EQ0

88 contrast media warmer NF 77 0 CMS clinical review EQ2

50 ultrasound unit, portable NF 77 0 CMS clinical review

ER02

9 film alternator (motorized film viewbox) NF 77 72 Refined equipment time to reflect typical use exclusive to patient

L037

D RN/LPN/MTA NF Greet patient, provide gowning, assure appropriate medical records are available 5 3 Standardi zed time input

L037

D RN/LPN/MTA NF Obtain vital signs 5 3 CMS clinical review643

CPT Code CPT Code Description CMS Code CMS Code Description NonFac / Fac Labor Activity (if applicable) AMA RUC Recomme ndation or

Current

Value (min or

qty) CMS Refine ment (min or qty) Comment

L041

B Radiologic Technologist NF Prepare room, equipment, supplies (including imaging equipment) 7 5 CMS clinical review

L041

B Radiologic Technologist NF Prepare and position patient/ monitor patient/ set up IV 5 2 Standardi zed time input
SB04

8 sheath-cover, sterile, 96in x 6in (transducer) NF 1 0 CMS clinical review SB04

8 sheath-cover, sterile, 96in x 6in (transducer) NF 1 0 CMS clinical review SD14

7 catheter, (Glide) NF 1 0 CMS clinical review SD25

2 guidewire, Amplatz wire 260 cm NF 1 0 CMS clinical review SH06

5 sodium chloride 0.9% flush

syringe NF 2 0 CMS clinical review SA05

3 pack, post-op incision care (suture & staple) F 1 0 CMS clinical review 47600 Removal of gallbladder SA05 4 pack, post-op incision care

(suture) F 0 1 CMS clinical review SA05

3 pack, post-op incision care (suture & staple) F 1 0 CMS clinical review 47605 Removal of gallbladder SA05 4 pack, post-op incision care

(suture) F 0 1 CMS clinical review

50590 Fragmentin g of kidney stone EL01 4 room,radiographicfluoroscopic NF 86 0 Consistent with the AMA RUC's CY2011 recommen dation644

CPT Code CPT Code Description CMS Code CMS Code Description NonFac / Fac Labor Activity (if applicable) AMA RUC Recomme ndation or

Current

Value (min or

qty) CMS Refine ment (min or qty) Comment

EQ1

75 lithotriptor, with C-arm (ESWL) NF 86 67 Refined equipment time to reflect typical use exclusive to patient

EF02

7 table, instrument, mobile NF 100 65 Refined equipment time to reflect typical use exclusive to patient

EF03

1 table, power NF 100 65 Refined equipment time to reflect typical use exclusive to patient

EQ1

37 instrument pack, basic ($500- $1499) NF 100 65 Refined equipment time to reflect typical use exclusive to patient

EQ1

53 laser (gs, uro, obg, ge) (Indigo

Optima) NF 100 65 Refined equipment time to reflect typical use exclusive to patient 52214 Cystoscopy and treatment

EQ1 67 light source, xenon NF 100 65 Refined equipment time to reflect typical use exclusive to patient645

CPT Code CPT Code Description CMS Code CMS Code Description NonFac / Fac Labor Activity (if applicable) AMA RUC Recomme ndation or

Current

Value (min or

qty) CMS Refine ment (min or qty) Comment

ES00

6 endoscope forceps, biopsy NF 100 65 Refined equipment time to reflect typical use exclusive to patient

ES00

7 endoscope forceps, grasping NF 100 65 Refined equipment time to reflect typical use exclusive to patient

ES01

8 fiberscope, flexible, cystoscopy NF 100 92 Refined equipment time to reflect typical use exclusive to patient

ES03

1 video system, endoscopy (processor, digital capture, monitor,

printer, cart) NF 100 65 Refined equipment time to reflect typical use exclusive to patient L037

D RN/LPN/MTA NF Review Chart 3 0 CMS clinical review SB01

9 drape-towel, sterile 18in x 26in NF 1 0 Duplicativ e SB02

4 gloves, sterile NF 0 1 CMS clinical review SD27

0 Penis clamp NF 1 0 Not a disposable supply SH04

7 lidocaine 1%-2% inj (Xylocaine) NF 50 0 Duplicativ e646

CPT Code CPT Code Description CMS Code CMS Code Description NonFac / Fac Labor Activity (if applicable) AMA RUC Recomme ndation or

Current

Value (min or

qty) CMS Refine ment (min or qty) Comment

EF02

7 table, instrument, mobile NF 105 67 Refined equipment time to reflect typical use exclusive to patient

EF03

1 table, power NF 105 67 Refined equipment time to reflect typical use exclusive to patient

EQ1

37 instrument pack, basic ($500- $1499) NF 105 67 Refined equipment time to reflect typical use exclusive to patient

EQ1

53 laser (gs, uro, obg, ge) (Indigo

Optima) NF 105 67 Refined equipment time to reflect typical use exclusive to patient

EQ1

67 light source, xenon NF 105 67 Refined equipment time to reflect typical use exclusive to patient 52224 Cystoscopy and treatment

ES00 6 endoscope forceps, biopsy NF 105 67 Refined equipment time to reflect typical use exclusive to patient647

CPT Code CPT Code Description CMS Code CMS Code Description NonFac / Fac Labor Activity (if applicable) AMA RUC Recomme ndation or

Current

Value (min or

qty) CMS Refine ment (min or qty) Comment

ES00

7 endoscope forceps, grasping NF 105 67 Refined equipment time to reflect typical use exclusive to patient

ES01

8 fiberscope, flexible, cystoscopy NF 105 94 Refined equipment time to reflect typical use exclusive to patient

ES03

1 video system, endoscopy (processor, digital capture, monitor,

printer, cart) NF 105 67 Refined equipment time to reflect typical use exclusive to patient L037

D RN/LPN/MTA NF Review Chart 3 0 CMS clinical review L037

D RN/LPN/MTA NF Prepare biopsy Specimen 5 2 CMS clinical review SB01

9 drape-towel, sterile 18in x 26in NF 1 0 Duplicativ e SB02

4 gloves, sterile NF 3 1 CMS clinical review

SD27

0 Penis clamp NF 1 0 Not a disposable according to submitted invoice SH04

7 lidocaine 1%-2% inj (Xylocaine) NF 50 0 Duplicativ e SL03

6 cup, biopsyspecimen sterile 4oz NF 6 3 CMS clinical review648

CPT Code CPT Code Description CMS Code CMS Code Description NonFac / Fac Labor Activity (if applicable) AMA RUC Recomme ndation or

Current

Value (min or

qty) CMS Refine ment (min or qty) Comment

EF02

7 table, instrument, mobile NF 78 49 Refined equipment time to reflect typical use exclusive to patient

EF03

1 table, power NF 78 49 Refined equipment time to reflect typical use exclusive to patient

EQ1

70 light, fiberopticheadlight wsource NF 78 49 Refined equipment time to reflect typical use exclusive to patient

ES01

8 fiberscope, flexible, cystoscopy NF 78 76 Refined equipment time to reflect typical use exclusive to patient

ES03

1 video system, endoscopy (processor, digital capture, monitor,

printer, cart) NF 78 49 Refined equipment time to reflect typical use exclusive to patient
L037

D RN/LPN/MTA NF Assist physician in performing procedure 20 21 Conformi ng to physician time 52287 Cystoscopy chemodener vation

SH04 8 lidocaine 2% jelly, topical (Xylocaine) NF 10 0 Duplicativ e649

CPT Code CPT Code Description CMS Code CMS Code Description NonFac / Fac Labor Activity (if applicable) AMA RUC Recomme ndation or

Current

Value (min or

qty) CMS Refine ment (min or qty) Comment

EF02

0 stretcher, endoscopy NF 99 85 Refined equipment time to reflect typical use exclusive to patient

EF02

7 table, instrument, mobile NF 99 85 Refined equipment time to reflect typical use exclusive to patient

EF03

1 table, power NF 169 152 Refined equipment time to reflect typical use exclusive to patient

EQ0

37 TUMT system control unit NF 99 85 Refined equipment time to reflect typical use exclusive to patient

EQ1

68 light, exam NF 169 152 Refined equipment time to reflect typical use exclusive to patient 53850 Prostatic microwave

thermotx

EQ1 68 light, exam F 169 152 Refined equipment time to reflect typical use exclusive to patient650

CPT Code CPT Code Description CMS Code CMS Code Description NonFac / Fac Labor Activity (if applicable) AMA RUC Recomme ndation or

Current

Value (min or

qty) CMS Refine ment (min or qty) Comment

EQ2

50 ultrasound unit, portable NF 99 85 Refined equipment time to reflect typical use exclusive to patient L037

D RN/LPN/MTA NF Prepare room, equipment, supplies 2 4 CMS clinical review L037

D RN/LPN/MTA NF Setup ultrasound probe 5 0 CMS clinical review L037

D RN/LPN/MTA NF Setup TUMT machine 5 0 CMS clinical review L037

D RN/LPN/MTA NF Clean TUMT machine 3 0 CMS clinical review SB02

2 gloves, non-sterile NF 3 2 CMS clinical review SB02

4 gloves, sterile NF 3 2 CMS clinical review SH04

7 lidocaine 1%-2% inj (Xylocaine) NF 3 30 CMS clinical review

EL00

6 lane, screening (oph) F 39 27 Refined equipment time to reflect typical use exclusive to patient

EL00

6 lane, screening (oph) NF 48 45 Refined equipment time to reflect typical use exclusive to patient 64612 Destroy nerve face

muscle

SC03 1 needle, 30g F 0 1 CMS clinical review651

CPT Code CPT Code Description CMS Code CMS Code Description NonFac / Fac Labor Activity (if applicable) AMA RUC Recomme ndation or

Current

Value (min or

qty) CMS Refine ment (min or qty) Comment

64615 Chemodene rv musc migraine EF02 3 table, exam NF 24 18 Refined equipment time to reflect typical use exclusive to patient

E711

1 Lane, Screening NF 21 22 Refined equipment time to reflect typical use exclusive to patient 65800 Drainage of eye
EQ1 37 instrument pack, basic ($500- $1499) NF 21 22 Refined equipment time to reflect typical use exclusive to patient

EF01

4 light, surgical NF 20 22 Refined equipment time to reflect typical use exclusive to patient

EF03

1 table, power NF 20 22 Refined equipment time to reflect typical use exclusive to patient 67810 Biopsy eyelid & lid

margin

EQ1 10 electrocauteryhyfrecator, up to 45 watts NF 1 22 Refined equipment time to reflect typical use exclusive to patient652

CPT Code CPT Code Description CMS Code CMS Code Description NonFac / Fac Labor Activity (if applicable) AMA RUC Recomme ndation or

Current

Value (min or

qty) CMS Refine ment (min or qty) Comment

EQ1

37 instrument pack, basic ($500- $1499) NF 1 30 Refined equipment time to reflect typical use exclusive to patient SB01

1 drape, sterile, fenestrated 16in x 29in NF 0 1 CMS clinical review SB01

9 drape-towel, sterile 18in x 26in NF 4 1 CMS clinical review SC02

9 needle, 18-27g NF 1 0 Standardi zed time input

ED0

25 film processor, wet NF 20 4 Refined equipment time to reflect typical use exclusive to patient

EL01

2 room, basic radiology NF 20 13 Refined equipment time to reflect typical use exclusive to patient

ER02

9 film alternator (motorized film viewbox) NF 20 4 Refined equipment time to reflect typical use exclusive to patient 72040 X-ray exam neck spine

3/<vws

Film jacket or jacket insert NF 1 0 Nonstandard direct practice expense input653

CPT Code CPT Code Description CMS Code CMS Code Description NonFac / Fac Labor Activity (if applicable) AMA RUC Recomme ndation or

Current

Value (min or

qty) CMS Refine ment (min or qty) Comment

ED0

25 film processor, wet NF 28 6 Refined equipment time to reflect typical use exclusive to patient

EL01

2 room, basic radiology NF 28 19 Refined equipment time to reflect typical use exclusive to patient

ER02

9 film alternator (motorized film viewbox) NF 28 6 Refined equipment time to reflect typical use exclusive to patient 72050 X-ray exam neck spine

4/5vws

Film jacket or jacket insert NF 1 0 Nonstandard direct practice expense input

ED0

25 film processor, wet NF 36 8 Refined equipment time to reflect typical use exclusive to patient 72052 X-ray exam neck spine

6/>vws

EL01 2 room, basic radiology NF 36 25 Refined equipment time to reflect typical use exclusive to patient654

CPT Code CPT Code Description CMS Code CMS Code Description NonFac / Fac Labor Activity (if applicable) AMA RUC Recomme ndation or

Current

Value (min or

qty) CMS Refine ment (min or qty) Comment

ER02

9 film alternator (motorized film viewbox) NF 36 8 Refined equipment time to reflect typical use exclusive to patient

Film jacket or jacket insert NF 1 0 Nonstandard direct practice expense input

EL00

7 room, CT NF 101 40 Refined equipment time to reflect typical use exclusive to patient

L041

B Radiologic Technologist NF - Retrieve prior appropriate imaging exams and hang for MD review, verify orders, review the chart to incorporate relevant clinical information 0 5 CMS Clinical Review

L041

B Radiologic Technologist NF Greet patient, provide gowning, assure appropriate medical records are available 0 3 CMS Clinical Review

L041

B Radiologic Technologist NF Education/instru ction/counseling /obtain consent 0 2 CMS Clinical Review L041

B Radiologic Technologist NF Prepare room, equipment, supplies 0 2 Standardi zed time input 72191 Ct angiograph pelv w/o&w/dye

L041 B Radiologic Technologist NF Prepare and position patient/ monitor patient/ set up IV 0 7 CMS Clinical Review655

CPT Code CPT Code Description CMS Code CMS Code Description NonFac / Fac Labor Activity (if applicable) AMA RUC Recomme ndation or

Current

Value (min or

qty) CMS Refine ment (min or qty) Comment

L041

B Radiologic Technologist NF Aquire images 0 28 CMS Clinical Review
L041

B Radiologic Technologist NF Clean room/equipment by physician staff 0 3 CMS Clinical Review

L046

A CT Technologist NF - Retrieve prior appropriate imaging exams and hang for MD review, verify orders, review the chart to incorporate relevant clinical information 5 0 CMS Clinical Review

L046

A CT Technologist NF Greet patient, provide gowning, assure appropriate medical records are available 3 0 CMS Clinical Review

L046

A CT Technologist NF Education/instru ction/counseling /obtain consent 2 0 CMS Clinical Review L046

A CT Technologist NF Prepare room, equipment, supplies 5 0 CMS Clinical Review
L046

A CT Technologist NF Prepare and position patient/ monitor patient/ set up IV 7 0 CMS Clinical Review
L046

A CT Technologist NF Aquire images 28 0 CMS Clinical Review
L046

A CT Technologist NF Clean room/equipment by physician staff 3 0 CMS Clinical Review
SK01

6 computer media, optical disk 2.6gb NF 1 0.1 CMS clinical review
72192 Ct pelvis w/o dye ED0 24 film processor, dry, laser NF 5 0 CMS clinical review656

CPT Code CPT Code Description CMS Code CMS Code Description NonFac / Fac Labor Activity (if applicable) AMA RUC Recomme ndation or

Current

Value (min or

qty) CMS Refine ment (min or qty) Comment

ED0

32 printer, laser, paper NF 0 5 CMS clinical review EL00

7 room, CT NF 45 22 CMS clinical review L046

A CT Technologist NF Pre-Service Period 6 4 CMS clinical review SK01

3 computer media, dvd NF 1 0 CMS clinical review SK01

6 computer media, optical disk 2.6gb NF 0 0.1 CMS clinical review SK07

6 slide sleeve (photo slides) NF 0 1 CMS clinical review SK09

1 x-ray envelope NF 1 0 CMS clinical review SK09

8 film, x-ray, laser print NF 4 8 CMS clinical review ED0

24 film processor, dry, laser NF 5 0 CMS clinical review ED0

32 printer, laser, paper NF 0 5 CMS clinical review EL00

7 room, CT NF 40 32 CMS clinical review L046

A CT Technologist NF Pre-Service Period 7 4 CMS clinical review L046

A CT Technologist NF Service Period 40 43 CMS clinical review SB00

6 drape, non-sterile, sheet 40in x 60in NF 1 0 CMS clinical review SB01

4 drape, sterile, three-quarter sheet NF 0 1 CMS clinical review 72193 Ct pelvis w/dye

SC00 1 angiocatheter 14g24g NF 1 0 CMS clinical review657

CPT Code CPT Code Description CMS Code CMS Code Description NonFac / Fac Labor Activity (if applicable) AMA RUC Recomme ndation or

Current

Value (min or

qty) CMS Refine ment (min or qty) Comment

SC00

2 angiocatheter set NF 0 1 CMS clinical review SC02

5 needle, 14-20g, biopsy NF 0 1 CMS clinical review SC02

9 needle, 18-27g NF 1 0 CMS clinical review SC05

9 syringe, 25ml (MRI power

injector) NF 0 1 CMS clinical review SG05

9 oto-wick NF 0 6 CMS clinical review SG06

8 plaster bandage (4in x 5yd uou) NF 1 0 CMS clinical review SG07

9 tape, surgical paper 1in (Micropore) NF 6 0 CMS clinical review SH06

5 sodium chloride 0.9% flush

syringe NF 0 15 CMS clinical review SK01

3 computer media, dvd NF 1 0 CMS clinical review SK01

6 computer media, optical disk 2.6gb NF 0 0.1 CMS clinical review SK07

6 slide sleeve (photo slides) NF 0 1 CMS clinical review SK09

1 x-ray envelope NF 1 0 CMS clinical review ED0

24 film processor, dry, laser NF 10 7 CMS clinical review EL00

7 room, CT NF 54 39 CMS clinical review ER02

9 film alternator (motorized film viewbox) NF 10 7 CMS clinical review 72194 Ct pelvis w/o & w/dye

L046 A CT Technologist NF Pre-Service Period 7 4 CMS clinical review658

CPT Code CPT Code Description CMS Code CMS Code Description NonFac / Fac Labor Activity (if applicable) AMA RUC Recomme ndation or

Current

Value (min or

qty) CMS Refine ment (min or qty) Comment

L046

A CT Technologist NF Service Period 54 52 CMS clinical review SC02

5 needle, 14-20g, biopsy NF 0 1 CMS clinical review SC02

9 needle, 18-27g NF 1 0 CMS clinical review SK01

3 computer media, dvd NF 1 0 CMS clinical review SK01

6 computer media, optical disk 2.6gb NF 0 0.1 CMS clinical review SK07

6 slide sleeve (photo slides) NF 0 1 CMS clinical review SK09

1 x-ray envelope NF 1 0 CMS clinical review SK09

8 film, x-ray, laser print NF 0 8 CMS clinical review

ED0

24 film processor, dry, laser NF 63 33 Refined equipment time to reflect typical use exclusive to patient

EL00

8 room, MR NF 63 33 Refined equipment time to reflect typical use exclusive to patient 73221 Mri joint upr extrem

w/o dye

ER02 9 film alternator (motorized film viewbox) NF 63 33 Refined equipment time to reflect typical use exclusive to patient659

CPT Code CPT Code Description CMS Code CMS Code Description NonFac / Fac Labor Activity (if applicable) AMA RUC Recomme ndation or

Current

Value (min or

qty) CMS Refine ment (min or qty) Comment

L047

A MRI Technologist NF Prepare room, equipment, supplies 5 3 CMS clinical review
L047

A MRI Technologist NF Prepare and position patient/ monitor patient/ set up IV 3 2 Standardi zed time input

L047

A MRI Technologist NF Escort patient from exam room due to magnetic sensitivity 2 0 Nonstandard direct practice expense input

Insert folder NF 1 0 Nonstandard direct practice expense input

ED0

24 film processor, dry, laser NF 63 33 Refined equipment time to reflect typical use exclusive to patient

EL00

8 room, MR NF 63 33 Refined equipment time to reflect typical use exclusive to patient

ER02

9 film alternator (motorized film viewbox) NF 63 33 Refined equipment time to reflect typical use exclusive to patient 73721 Mri jnt of lwr extre w/o dye

L047 A MRI Technologist NF Prepare room, equipment, supplies 5 3 CMS clinical review660

CPT Code CPT Code Description CMS Code CMS Code Description NonFac / Fac Labor Activity (if applicable) AMA RUC Recomme ndation or

Current

Value (min or

qty) CMS Refine ment (min or qty) Comment

L047

A MRI Technologist NF Prepare and position patient/ monitor patient/ set up IV 3 2 Standardi zed time input

L047

A MRI Technologist NF Escort patient from exam room due to magnetic sensitivity 2 0 Nonstandard direct practice expense input

Insert folder NF 1 0 Nonstandard direct practice expense input ED0

24 film processor, dry, laser NF 5 0 CMS clinical review ED0

32 printer, laser, paper NF 0 5 CMS clinical review EL00

7 room, CT NF 32 22 CMS clinical review L046

A CT Technologist NF Pre-Service Period 6 4 CMS clinical review SK01

3 computer media, dvd NF 1 0 CMS clinical review SK01

6 computer media, optical disk 2.6gb NF 0 0.1 CMS clinical review SK07

6 slide sleeve (photo slides) NF 0 1 CMS clinical review SK09

1 x-ray envelope NF 1 0 CMS clinical review 74150 Ct abdomen w/o dye

SK09 8 film, x-ray, laser print NF 4 8 CMS clinical review ED0

24 film processor, dry, laser NF 7 0 CMS clinical review 74160 Ct abdomen w/dye
ED0 32 printer, laser, paper NF 0 5 CMS clinical review661

CPT Code CPT Code Description CMS Code CMS Code Description NonFac / Fac Labor Activity (if applicable) AMA RUC Recomme ndation or

Current

Value (min or

qty) CMS Refine ment (min or qty) Comment

EL00

7 room, CT NF 47 32 CMS clinical review ER02

9 film alternator (motorized film viewbox) NF 7 5 CMS clinical review L046

A CT Technologist NF Pre-Service Period 7 4 CMS clinical review L046

A CT Technologist NF Service Period 47 43 CMS clinical review SB00

6 drape, non-sterile, sheet 40in x 60in NF 1 0 CMS clinical review SB01

4 drape, sterile, three-quarter sheet NF 0 1 CMS clinical review SC00

1 angiocatheter 14g24g NF 1 0 CMS clinical review SC00

2 angiocatheter set NF 0 1 CMS clinical review SC02

5 needle, 14-20g, biopsy NF 0 1 CMS clinical review SC02

9 needle, 18-27g NF 1 0 CMS clinical review SC05

9 syringe, 25ml (MRI power

injector) NF 0 1 CMS clinical review SG05

9 oto-wick NF 0 1 CMS clinical review
SG07

5 tape, elastic, 1in (Elastoplast, Elasticon) (5yd uou) NF 0 6 CMS clinical review
SG07

9 tape, surgical paper 1in (Micropore) NF 6 0 CMS clinical review SH06

5 sodium chloride 0.9% flush

syringe NF 0 15 CMS clinical review662

CPT Code CPT Code Description CMS Code CMS Code Description NonFac / Fac Labor Activity (if applicable) AMA RUC Recomme ndation or

Current

Value (min or

qty) CMS Refine ment (min or qty) Comment

SH06

8 sodium chloride 0.9% inj bacteriostatic

(30ml uou) NF 1 0 CMS clinical review
SK01

3 computer media, dvd NF 1 0 CMS clinical review SK01

6 computer media, optical disk 2.6gb NF 0 0.1 CMS clinical review SK07

6 slide sleeve (photo slides) NF 0 1 CMS clinical review SK09

1 x-ray envelope NF 1 0 CMS clinical review SK09

8 film, x-ray, laser print NF 6 4 CMS clinical review

ED0

24 film processor, dry, laser NF 15 7 Refined equipment time to reflect typical use exclusive to patient

EL00

7 room, CT NF 65 39 Refined equipment time to reflect typical use exclusive to patient 74170 Ct abdomen w/o & w/dye

ER02 9 film alternator (motorized film viewbox) NF 15 7 Refined equipment time to reflect typical use exclusive to patient663

CPT Code CPT Code Description CMS Code CMS Code Description NonFac / Fac Labor Activity (if applicable) AMA RUC Recomme ndation or

Current

Value (min or

qty) CMS Refine ment (min or qty) Comment

L046

A CT Technologist NF - Retrieve prior appropriate imaging exams and hang for MD review, verify orders, review the chart to incorporate relevant clinical information and confirm contrast protocol with interpreting MD 7 4 CMS clinical review

L046

A CT Technologist NF Assist physician in performing procedure 32 27 CMS clinical review L046

A CT Technologist NF Image Post Processing 15 7 CMS clinical review SB00

6 drape, non-sterile, sheet 40in x 60in NF 1 0 CMS clinical review SB01

4 drape, sterile, three-quarter sheet NF 0 1 CMS clinical review SC00

1 angiocatheter 14g24g NF 1 0 CMS clinical review SC00

2 angiocatheter set NF 0 1 CMS clinical review SC02

5 needle, 14-20g, biopsy NF 0 1 CMS clinical review SC02

9 needle, 18-27g NF 1 0 CMS clinical review SC05

9 syringe, 25ml (MRI power

injector) NF 0 1 CMS clinical review
SG07

5 tape, elastic, 1in (Elastoplast, Elasticon) (5yd uou) NF 0 6 CMS clinical review
SG07

9 tape, surgical paper 1in (Micropore) NF 6 0 CMS clinical review664

CPT Code CPT Code Description CMS Code CMS Code Description NonFac / Fac Labor Activity (if applicable) AMA RUC Recomme ndation or

Current

Value (min or

qty) CMS Refine ment (min or qty) Comment

SH01

6 barium suspension (Polibar) NF 900 0 CMS clinical review SH06

5 sodium chloride 0.9% flush

syringe NF 0 15 CMS clinical review
SH06

8 sodium chloride 0.9% inj bacteriostatic

(30ml uou) NF 1 0 CMS clinical review
SK01

3 computer media, dvd NF 1 0 CMS clinical review SK01

6 computer media, optical disk 2.6gb NF 0 0.1 CMS clinical review SK05

0 neurobehavioral status forms,

average NF 0 1 CMS clinical review SK07

6 slide sleeve (photo slides) NF 0 1 CMS clinical review SK09

1 x-ray envelope NF 1 0 CMS clinical review SK09

8 film, x-ray, laser print NF 14 8 CMS clinical review

EL00

7 room, CT NF 101 40 Refined equipment time to reflect typical use exclusive to patient 74175 Ct angio abdom w/o

& w/dye

L041 B Radiologic Technologist NF - Retrieve prior appropriate imaging exams and hang for MD review, verify orders, review the chart to incorporate relevant clinical information 0 5 CMS clinical review665

CPT Code CPT Code Description CMS Code CMS Code Description NonFac / Fac Labor Activity (if applicable) AMA RUC Recomme ndation or

Current

Value (min or

qty) CMS Refine ment (min or qty) Comment

L041

B Radiologic Technologist NF Greet patient, provide gowning, assure appropriate medical records are available 0 3 CMS clinical review

L041

B Radiologic Technologist NF Education/instru ction/counseling /obtain consent 0 2 CMS clinical review L041

B Radiologic Technologist NF Prepare room, equipment, supplies 0 2 Standardi zed time input
L041

B Radiologic Technologist NF Prepare and position patient/ monitor patient/ set up IV 0 7 CMS clinical review
L041

B Radiologic Technologist NF Aquire images 0 28 CMS clinical review
L041

B Radiologic Technologist NF Clean room/equipment by physician staff 0 3 CMS clinical review

L046

A CT Technologist NF - Retrieve prior appropriate imaging exams and hang for MD review, verify orders, review the chart to incorporate relevant clinical information 5 0 CMS clinical review

L046

A CT Technologist NF Greet patient, provide gowning, assure appropriate medical records are available 3 0 CMS clinical review

L046

A CT Technologist NF Education/instru ction/counseling /obtain consent 2 0 CMS clinical review L046

A CT Technologist NF Prepare room, equipment, supplies 5 0 CMS clinical review666

CPT Code CPT Code Description CMS Code CMS Code Description NonFac / Fac Labor Activity (if applicable) AMA RUC Recomme ndation or

Current

Value (min or

qty) CMS Refine ment (min or qty) Comment

L046

A CT Technologist NF Prepare and position patient/ monitor patient/ set up IV 7 0 CMS clinical review
L046

A CT Technologist NF Aquire images 28 0 CMS clinical review
L046

A CT Technologist NF Clean room/equipment by physician staff 3 0 CMS clinical review
SK01

6 computer media, optical disk 2.6gb NF 1 0.1 CMS clinical review ED0

32 printer, laser, paper NF 8 7 CMS clinical review ER02

9 film alternator (motorized film viewbox) NF 27 7 CMS clinical review L046

A CT Technologist NF Service Period 40 39 CMS clinical review SK01

6 computer media, optical disk 2.6gb NF 0 0.1 CMS clinical review 74176 Ct abd & pelvis

SK07 6 slide sleeve (photo slides) NF 0 1 CMS clinical review ED0

32 printer, laser, paper NF 10 7 CMS clinical review EL00

7 room, CT NF 42 39 CMS clinical review ER02

9 film alternator (motorized film viewbox) NF 42 7 CMS clinical review L046

A CT Technologist NF Pre-Service Period 7 6 CMS clinical review L046

A CT Technologist NF Service Period 58 52 CMS clinical review 74177 Ct abd & pelv w/contrast

SK01 6 computer media, optical disk 2.6gb NF 0 0.1 CMS clinical review667

CPT Code CPT Code Description CMS Code CMS Code Description NonFac / Fac Labor Activity (if applicable) AMA RUC Recomme ndation or

Current

Value (min or

qty) CMS Refine ment (min or qty) Comment

SK07

6 slide sleeve (photo slides) NF 0 1 CMS clinical review SK09

8 film, x-ray, laser print NF 10 8 CMS clinical review ED0

32 printer, laser, paper NF 20 10 CMS clinical review EL00

7 room, CT NF 57 48 CMS clinical review ER02

9 film alternator (motorized film viewbox) NF 57 10 CMS clinical review L046

A CT Technologist NF Pre-Service Period 7 6 CMS clinical review L046

A CT Technologist NF Service Period 83 64 CMS clinical review SK01

6 computer media, optical disk 2.6gb NF 0 0.1 CMS clinical review SK07

6 slide sleeve (photo slides) NF 0 1 CMS clinical review 74178 Ct abd & pelv 1/>

regns

SK09 8 film, x-ray, laser print NF 23 16 CMS clinical review ED0

24 film processor, dry, laser NF 5 0 CMS clinical review ED0

32 printer, laser, paper NF 1 0 CMS clinical review 76830 Transvagina l us non-ob

EF02 7 table, instrument, mobile NF 0 36 Refined equipment time to reflect typical use exclusive to patient668

CPT Code CPT Code Description CMS Code CMS Code Description NonFac / Fac Labor Activity (if applicable) AMA RUC Recomme ndation or

Current

Value (min or

qty) CMS Refine ment (min or qty) Comment

EF03

4 table, ultrasound NF 0 36 Refined equipment time to reflect typical use exclusive to patient EL01

5 room, ultrasound, general NF 37 0 CMS clinical review

EQ2

50 ultrasound unit, portable NF 0 36 Refined equipment time to reflect typical use exclusive to patient ER02

9 film alternator (motorized film viewbox) NF 10 0 CMS clinical review

ER08

6 ultrasound probe NF 0 37 Refined equipment time to reflect typical use exclusive to patient
L051

B RN/Diagnostic Medical Sonographer NF Clean room/equipment by physician staff 3 2 CMS clinical review
SB02

6 gown, patient NF 0 1 CMS clinical review SJ03

3 lubricating jelly (Surgilube) NF 1 0 CMS clinical review

76872 Us transrectal EF02 7 table, instrument, mobile NF 68 34 Refined equipment time to reflect typical use exclusive to patient669

CPT Code CPT Code Description CMS Code CMS Code Description NonFac / Fac Labor Activity (if applicable) AMA RUC Recomme ndation or

Current

Value (min or

qty) CMS Refine ment (min or qty) Comment

EF03

4 table, ultrasound NF 68 34 Refined equipment time to reflect typical use exclusive to patient

EQ2

50 ultrasound unit, portable NF 68 34 Refined equipment time to reflect typical use exclusive to patient

ER08

6 ultrasound probe NF 68 35 Refined equipment time to reflect typical use exclusive to patient L051

B RN/Diagnostic Medical Sonographer NF Retrieve prior images for comparison: 0 3 CMS clinical review L051

B RN/Diagnostic Medical Sonographer NF Review Chart 3 0 CMS clinical review L051

B RN/Diagnostic Medical Sonographer NF Obtain vital signs 3 0 CMS clinical review L051

B RN/Diagnostic Medical Sonographer NF Prepare room, equipment, supplies 2 3 CMS clinical review L051

B RN/Diagnostic Medical Sonographer NF Prepare ultrasound probe 5 0 CMS clinical review L051

B RN/Diagnostic Medical Sonographer NF Obtain vital signs 3 0 CMS clinical review
L051

B RN/Diagnostic Medical Sonographer NF Clean room/equipment by physician staff 3 2 CMS clinical review
SB01

2 drape, sterile, for Mayo stand NF 1 0 CMS clinical review670

CPT Code CPT Code Description CMS Code CMS Code Description NonFac / Fac Labor Activity (if applicable) AMA RUC Recomme ndation or

Current

Value (min or

qty) CMS Refine ment (min or qty) Comment

SC01

9 iv tubing (extension) NF 1 0 CMS clinical review SH04

8 lidocaine 2% jelly, topical (Xylocaine) NF 10 0 CMS clinical review SJ00

1 alcohol isopropyl 70% NF 5 0 CMS clinical review SJ03

2 lubricating jelly (K-Y) (5gm uou) NF 2 0 CMS clinical review
SM0

18 glutaraldehyde 3.4% (Cidex,

Maxicide, Wavicide) NF 32 0 CMS clinical review
SM0

19 glutaraldehyde test strips (Cidex, Metrex) NF 1 0 CMS clinical review
SM0

22 sanitizing clothwipe (surface, instruments, equipment) NF 2 0 CMS clinical review

ED0

25 film processor, wet NF 3 2 Refined equipment time to reflect typical use exclusive to patient

EL01

4 room,radiographicfluoroscopic NF 9 18 Refined equipment time to reflect typical use exclusive to patient 77003 Fluoroguide for spine

inject

ER02 9 film alternator (motorized film viewbox) NF 3 2 Refined equipment time to reflect typical use exclusive to patient671

CPT Code CPT Code Description CMS Code CMS Code Description NonFac / Fac Labor Activity (if applicable) AMA RUC Recomme ndation or

Current

Value (min or

qty) CMS Refine ment (min or qty) Comment

L041

B Radiologic Technologist NF Clean room/equipment by physician staff 2 1 CMS clinical review

L041

B Radiologic Technologist NF Process films, hang films and review study with interpreting MD prior to patient discharge 3 2 CMS clinical review

77080 Dxa bone density

axial ER07 8 phantom, spine, DXA calibration check NF 1 2 Refined equipment time to reflect typical use exclusive to patient ED0

11 computer system, record and verify NF 20 0 CMS clinical review

ED0

33 treatment planning system,IMRT (Corvus wPeregrine 3D Monte Carlo) NF 376 330 CMS clinical review

ER00

5 IMRT CT-based simulator NF 58 47 CMS clinical review

ER01

4 chamber, Farmertype NF 45 47 Refined equipment time to reflect typical use exclusive to patient 77301 Radiotherap y dose plan imrt

ER02 8 electrometer, PCbased, dual

channel NF 45 47 Refined equipment time to reflect typical use exclusive to patient672

CPT Code CPT Code Description CMS Code CMS Code Description NonFac / Fac Labor Activity (if applicable) AMA RUC Recomme ndation or

Current

Value (min or

qty) CMS Refine ment (min or qty) Comment

ER05

0 phantom, solid water calibration check NF 45 47 Refined equipment time to reflect typical use exclusive to patient ER08

9 IMRT accelerator NF 45 47 CMS clinical review L037

D RN/LPN/MTA NF Obtain vital signs 3 0 CMS clinical review

EF01

0 chair, thyroid imaging NF 40 30 Refined equipment time to reflect typical use exclusive to patient 78012 Thyroid uptake measureme nt ER06 3 thyroid uptake system NF 40 30 Refined equipment time to reflect typical use exclusive to patient

78013 Thyroid imaging w/blood flow ER03 2 gamma camerasystem, singledual head NF 48 38 Refined equipment time to reflect typical use exclusive to patient

78014 Thyroid imaging w/blood

flow EF01 0 chair, thyroid imaging NF 65 55 Refined equipment time to reflect typical use exclusive to patient673

CPT Code CPT Code Description CMS Code CMS Code Description NonFac / Fac Labor Activity (if applicable) AMA RUC Recomme ndation or

Current

Value (min or

qty) CMS Refine ment (min or qty) Comment

ER03

2 gamma camerasystem, singledual head NF 65 50 Refined equipment time to reflect typical use exclusive to patient

ER06

3 thyroid uptake system NF 65 55 Refined equipment time to reflect typical use exclusive to patient

78070 Parathyroid planar imaging ER03 2 gamma camerasystem, singledual head NF 73 68 Refined equipment time to reflect typical use exclusive to patient

78071 Parathyrd planar w/wo subtrj ER03 2 gamma camerasystem, singledual head NF 86 81 Refined equipment time to reflect typical use exclusive to patient

EP10

6 CELLSEARCH system NF 16 0 Laborator y Physician Interpretat ion Code

EP10

7 Laboratory Information

System NF 4 0 Laborator y Physician Interpretat ion Code 86153 Cell enumeratio

n phys interp

L045 A Cytotechnologist NF Collate images and review with Pathologist 5 0 Laborator y Physician Interpretat ion Code674

CPT Code CPT Code Description CMS Code CMS Code Description NonFac / Fac Labor Activity (if applicable) AMA RUC Recomme ndation or

Current

Value (min or

qty) CMS Refine ment (min or qty) Comment

EP08

8 ThermoBrite NF 107 321 CMS clinical review 88120 Cytp urne 3-5 probes

ea spec EP09 2 Olympus BX41 Fluorescent Microscope (without filters or camera) NF 1.33 73 CMS clinical review

EP08

8 ThermoBrite NF 26.75 160.5 CMS clinical review EP09

0 IkoniScope NF 2.97 29.7 CMS clinical review 88121 Cytp urine 3-5 probes

cmptr EP09 1 IkoniLan software NF 2.97 29.7 CMS clinical review courier transportation cost NF 2.02 0 Indirect Practice Expense Copath System with maintenance contract NF 3 0 Indirect Practice Expense 88300 Surgical path gross

Copath software NF 3 0 Indirect Practice Expense specimen, solvent, and formalin disposal cost NF 0.18 0 Indirect Practice Expense courier transportation cost NF 2.02 0 Indirect Practice Expense

equipment maintenance cost NF 0.61 0 Included in equipment cost per minute calculatio n Copath System with maintenance contract NF 3 0 Indirect Practice Expense 88302 Tissue exam by pathologist

Copath software NF 3 0 Indirect Practice Expense675

CPT Code CPT Code Description CMS Code CMS Code Description NonFac / Fac Labor Activity (if applicable) AMA RUC Recomme ndation or

Current

Value (min or

qty) CMS Refine ment (min or qty) Comment

specimen, solvent, and formalin disposal cost NF 0.35 0 Indirect Practice Expense courier transportation cost NF 2.02 0 Indirect Practice Expense

equipment maintenance cost NF 0.61 0 Included in equipment cost per minute calculatio n Copath System with maintenance contract NF 5 0 Indirect Practice Expense 88304 Tissue exam by pathologist

Copath software NF 5 0 Indirect Practice Expense specimen, solvent, and formalin disposal cost NF 0.35 0 Indirect Practice Expense courier transportation cost NF 2.02 0 Indirect Practice Expense

equipment maintenance cost NF 0.61 0 Included in equipment cost per minute calculatio n Copath System with maintenance contract NF 4 0 Indirect Practice Expense 88305 Tissue exam by pathologist

Copath software NF 4 0 Indirect Practice Expense specimen, solvent, and formalin disposal cost NF 1.85 0 Indirect Practice Expense 88307 Tissue exam by pathologist courier transportation cost NF 2.02 0 Indirect Practice Expense676

CPT Code CPT Code Description CMS Code CMS Code Description NonFac / Fac Labor Activity (if applicable) AMA RUC Recomme ndation or

Current

Value (min or

qty) CMS Refine ment (min or qty) Comment

equipment maintenance cost NF 0.61 0 Included in equipment cost per minute calculatio n Copath System with maintenance contract NF 10 0 Indirect Practice Expense Copath software NF 10 0 Indirect Practice Expense specimen, solvent, and formalin disposal cost NF 1.85 0 Indirect Practice Expense courier transportation cost NF 2.02 0 Indirect Practice Expense

equipment maintenance cost NF 0.61 0 Included in equipment cost per minute calculatio n Copath System with maintenance contract NF 12 0 Indirect Practice Expense 88309 Tissue exam by pathologist

Copath software NF 12 0 Indirect Practice Expense

90791 Psych diagnostic evaluation NF 2012 Fully Implemen ted PE RVUs maintaine d

90832 Psytx pt&/family 30 minutes NF 2012 Fully Implemen ted PE RVUs maintaine d677

CPT Code CPT Code Description CMS Code CMS Code Description NonFac / Fac Labor Activity (if applicable) AMA RUC Recomme ndation or

Current

Value (min or

qty) CMS Refine ment (min or qty) Comment

90834 Psytx pt&/family 45 minutes NF 2012 Fully Implemen ted PE RVUs maintaine d

90836 Psytx pt&/fam w/e&m 45 min NF 2012 Fully Implemen ted PE RVUs maintaine d EQ3

52 Data receiver NF 7220 2880 CMS clinical review SA04

8 pack, minimum multi-specialty visit NF 1 0 CMS clinical review 91112 Gi wireless capsule measure SK11 6 SmartBar NF 1 0 CMS clinical review

92081 Visual field examination (s) EL00 6 lane, screening (oph) NF 12 17 Refined equipment time to reflect typical use exclusive to patient

92082 Visual field examination (s) EL00 6 lane, screening (oph) NF 22 27 Refined equipment time to reflect typical use exclusive to patient

92083 Visual field examination (s) EL00 6 lane, screening (oph) NF 32 37 Refined equipment time to reflect typical use exclusive to patient678

CPT Code CPT Code Description CMS Code CMS Code Description NonFac / Fac Labor Activity (if applicable) AMA RUC Recomme ndation or

Current

Value (min or

qty) CMS Refine ment (min or qty) Comment

ED0

08 camera, retinal(TRC 50IX, wICG, filters, motor drives) NF 60 35 Refined equipment time to reflect typical use exclusive to patient

EF03

0 table, motorized(for instrumentsequipment) NF 60 35 Refined equipment time to reflect typical use exclusive to patient

EL00

5 lane, exam (oph) NF 60 35 Refined equipment time to reflect typical use exclusive to patient

L038

A COMT/COT/RN/ CST NF Monitor pt. following service/check tubes, monitors, drains 5 2 CMS clinical review 92235 Eye exam with photos

L039 A Certified Retinal Angio NF Assist physician in performing procedure 40 20 CMS clinical review

EF02

3 table, exam NF 58 46 Refined equipment time to reflect typical use exclusive to patient 93015 Cardiovasc ular stress test

EQ0 78 cardiac monitor w-treadmill (12-

lead PC-based ECG) NF 58 46 Refined equipment time to reflect typical use exclusive to patient679

CPT Code CPT Code Description CMS Code CMS Code Description NonFac / Fac Labor Activity (if applicable) AMA RUC Recomme ndation or

Current

Value (min or

qty) CMS Refine ment (min or qty) Comment

L051

A RN NF Assist physician in performing procedure 20 14 CMS clinical review

EF02

3 table, exam NF 58 46 Refined equipment time to reflect typical use exclusive to patient

EQ0

78 cardiac monitor w-treadmill (12-

lead PC-based ECG) NF 58 46 Refined equipment time to reflect typical use exclusive to patient L051

A RN NF Assist physician in performing procedure 20 14 CMS clinical review 93017 Cardiovasc ular stress test

L051 A RN NF Complete diagnosticforms, lab & Xray requisitions 0 4 CMS clinical review
ED0

11 computer system, record and verify NF 10 0 CMS clinical review

ED0

21 computer,desktop, wmonitor NF 95 7 Refined equipment time to reflect typical use exclusive to patient

ED0

25 film processor, wet NF 10 7 Refined equipment time to reflect typical use exclusive to patient 93925 Lower extremity

study

ED0 34 video SVHS VCR (medical grade) NF 95 0 CMS clinical review680

CPT Code CPT Code Description CMS Code CMS Code Description NonFac / Fac Labor Activity (if applicable) AMA RUC Recomme ndation or

Current

Value (min or

qty) CMS Refine ment (min or qty) Comment

EL01

6 room, ultrasound, vascular NF 95 76 Refined equipment time to reflect typical use exclusive to patient

ER06

7 x-ray view box, 4 panel NF 10 7 Refined equipment time to reflect typical use exclusive to patient
L054

A Vascular Technologist NF Provide preservice education/obtai n consent 3 2 CMS clinical review
L054

A Vascular Technologist NF Prepare room, equipment, supplies 3 2 Standardi zed time input L054

A Vascular Technologist NF Prepare and position patient 3 2 Standardi zed time input

L054

A Vascular Technologist NF Other Clinical Activity: Collate preliminary data, arrange images, archive 10 7 CMS clinical review

L054

A Vascular Technologist NF Other Clinical Activity: Record patient history 1 0 CMS clinical review
L054

A Vascular Technologist NF Other Clinical Activity: QA documentation 4 0 CMS clinical review SK08

6 video tape, VHS NF 1 0 CMS clinical review
93926 Lower extremity

study ED0 11 computer system, record and verify NF 10 0 CMS clinical review681

CPT Code CPT Code Description CMS Code CMS Code Description NonFac / Fac Labor Activity (if applicable) AMA RUC Recomme ndation or

Current

Value (min or

qty) CMS Refine ment (min or qty) Comment

ED0

21 computer,desktop, wmonitor NF 59 4 Refined equipment time to reflect typical use exclusive to patient

ED0

25 film processor, wet NF 10 4 Refined equipment time to reflect typical use exclusive to patient ED0

34 video SVHS VCR (medical grade) NF 59 0 CMS clinical review

EL01

6 room, ultrasound, vascular NF 59 42 Refined equipment time to reflect typical use exclusive to patient

ER06

7 x-ray view box, 4 panel NF 10 4 Refined equipment time to reflect typical use exclusive to patient
L054

A Vascular Technologist NF Provide preservice education/obtai n consent 3 2 CMS clinical review
L054

A Vascular Technologist NF Prepare room, equipment, supplies 3 2 Standardi zed time input L054

A Vascular Technologist NF Prepare and position patient 3 2 Standardi zed time input682

CPT Code CPT Code Description CMS Code CMS Code Description NonFac / Fac Labor Activity (if applicable) AMA RUC Recomme ndation or

Current

Value (min or

qty) CMS Refine ment (min or qty) Comment

L054

A Vascular Technologist NF Other Clinical Activity: Collate preliminary data, arrange images, archive 8 4 CMS clinical review

L054

A Vascular Technologist NF Other Clinical Activity: Record patient history 1 0 CMS clinical review
L054

A Vascular Technologist NF Other Clinical Activity: QA documentation 4 0 CMS clinical review SK08

6 video tape, VHS NF 1 0 CMS clinical review ED0

11 computer system, record and verify NF 10 0 CMS clinical review

ED0

21 computer,desktop, wmonitor NF 71 7 Refined equipment time to reflect typical use exclusive to patient

ED0

25 film processor, wet NF 10 7 Refined equipment time to reflect typical use exclusive to patient ED0

34 video SVHS VCR (medical grade) NF 71 0 CMS clinical review 93970 Extremity study

EL01 6 room, ultrasound, vascular NF 71 52 Refined equipment time to reflect typical use exclusive to patient683

CPT Code CPT Code Description CMS Code CMS Code Description NonFac / Fac Labor Activity (if applicable) AMA RUC Recomme ndation or

Current

Value (min or

qty) CMS Refine ment (min or qty) Comment

ER06

7 x-ray view box, 4 panel NF 10 7 Refined equipment time to reflect typical use exclusive to patient
L054

A Vascular Technologist NF Provide preservice education/obtai n consent 3 2 CMS clinical review
L054

A Vascular Technologist NF Prepare room, equipment, supplies 3 2 Standardi zed time input L054

A Vascular Technologist NF Prepare and position patient 3 2 Standardi zed time input

L054

A Vascular Technologist NF Other Clinical Activity: Collate preliminary data, arrange images, archive 10 7 CMS clinical review

L054

A Vascular Technologist NF Other Clinical Activity: Record patient history 1 0 CMS clinical review
L054

A Vascular Technologist NF Other Clinical Activity: QA documentation 4 0 CMS clinical review SK08

6 video tape, VHS NF 1 0 CMS clinical review ED0

11 computer system, record and verify NF 10 0 CMS clinical review 93971 Extremity study

ED0 21 computer,desktop, wmonitor NF 45 4 Refined equipment time to reflect typical use exclusive to patient684

CPT Code CPT Code Description CMS Code CMS Code Description NonFac / Fac Labor Activity (if applicable) AMA RUC Recomme ndation or

Current

Value (min or

qty) CMS Refine ment (min or qty) Comment

ED0

25 film processor, wet NF 10 4 Refined equipment time to reflect typical use exclusive to patient ED0

34 video SVHS VCR (medical grade) NF 45 0 CMS clinical review EL01

6 room, ultrasound, vascular NF 45 30 CMS clinical review

ER06

7 x-ray view box, 4 panel NF 10 4 Refined equipment time to reflect typical use exclusive to patient
L054

A Vascular Technologist NF Provide preservice education/obtai n consent 3 2 CMS clinical review
L054

A Vascular Technologist NF Prepare room, equipment, supplies 3 2 Standardi zed time input L054

A Vascular Technologist NF Prepare and position patient 3 2 Standardi zed time input

L054

A Vascular Technologist NF Other Clinical Activity: Collate preliminary data, arrange images, archive 6 4 CMS clinical review

L054

A Vascular Technologist NF Other Clinical Activity: Record patient history 1 0 CMS clinical review
L054

A Vascular Technologist NF Other Clinical Activity: QA documentation 4 0 CMS clinical review SB00

6 drape, non-sterile, sheet 40in x 60in NF 2 1 CMS clinical review685

CPT Code CPT Code Description CMS Code CMS Code Description NonFac / Fac Labor Activity (if applicable) AMA RUC Recomme ndation or

Current

Value (min or

qty) CMS Refine ment (min or qty) Comment

SK08

6 video tape, VHS NF 1 0 CMS clinical review

EF02

3 table, exam NF 141 133 Refined equipment time to reflect typical use exclusive to patient

EQ1

68 light, exam NF 141 133 Refined equipment time to reflect typical use exclusive to patient 95076 Ingest challenge ini 120 min

L037 D RN/LPN/MTA NF Prepare testing doses 15 7 CMS clinical review

95115 Immunother apy one injection EF04 0 refrigerator, vaccine, commercial grade, w-alarm lock NF 15 0 CMS clinical review

95117 Immunother apy injections EF04 1 x-ray machine, portable NF 17 0 CMS clinical review

EF00

3 bedroom furniture (hospital bed, table, reclining chair) NF 660 602 Refined equipment time to reflect typical use exclusive to patient EF04

4 Crib NF 660 0 CMS clinical review 95782 Polysom <6 yrs 4/> paramtrs

EQ1 34 impedance meter, 32-channel NF 660 602 Refined equipment time to reflect typical use exclusive to patient686

CPT Code CPT Code Description CMS Code CMS Code Description NonFac / Fac Labor Activity (if applicable) AMA RUC Recomme ndation or

Current

Value (min or

qty) CMS Refine ment (min or qty) Comment

EQ2

72 sleep diagnostic system, attended

(w-acquisition station, review master, computer) NF 660 662 Refined equipment time to reflect typical use exclusive to patient EQ3

48 Capnograph NF 660 0 CMS clinical review

ER08

8 Infrared illuminator NF 660 602 Refined equipment time to reflect typical use exclusive to patient
L047

B REEGT NF Provide preservice education/obtai n consent 5 3 CMS clinical review

L047

B REEGT NF Other Clinical Activity - specify: Set up and calibrate all monitoring and recording equipment (initial), including capnograph (for child) 6 5 CMS clinical review687

CPT Code CPT Code Description CMS Code CMS Code Description NonFac / Fac Labor Activity (if applicable) AMA RUC Recomme ndation or

Current

Value (min or

qty) CMS Refine ment (min or qty) Comment

L047

B REEGT NF Other Clinical Activity - specify: Measure and mark head and face. Apply and secure electrodes to head and face. Check impedances. Reapply electrodes as needed. (1.5 min per electrode for child, 1 min per electrode for adult) 30 20 CMS clinical review

L047

B REEGT NF Other Clinical Activity - specify: Apply recording devices forcardiorespiratory, leg movements, body positioning and snoring 0 15 CMS clinical review

L047

B REEGT NF Other Clinical Activity - specify: Apply recording devices forcardiorespiratory, leg movements, body positioning, snoring and capnography 20 0 CMS clinical review688

CPT Code CPT Code Description CMS Code CMS Code Description NonFac / Fac Labor Activity (if applicable) AMA RUC Recomme ndation or

Current

Value (min or

qty) CMS Refine ment (min or qty) Comment

L047

B REEGT NF Other Clinical Activity - specify: Daytime tech reviews and edits recording, marks artifacts, scores sleep stages, performs evaluation of physiological changes 100 97 CMS clinical review

EF00

3 bedroom furniture (hospital bed, table, reclining chair) NF 660 647 Refined equipment time to reflect typical use exclusive to patient EF04

4 Crib NF 660 0 CMS clinical review

EQ1

34 impedance meter, 32-channel NF 660 647 Refined equipment time to reflect typical use exclusive to patient

EQ2

72 sleep diagnostic system, attended

(w-acquisition station, review master, computer) NF 660 707 Refined equipment time to reflect typical use exclusive to patient EQ3

48 Capnograph NF 660 0 CMS clinical review 95783 Polysom <6 yrs cpap/bilvl

ER08 8 Infrared illuminator NF 660 647 Refined equipment time to reflect typical use exclusive to patient689

CPT Code CPT Code Description CMS Code CMS Code Description NonFac / Fac Labor Activity (if applicable) AMA RUC Recomme ndation or

Current

Value (min or

qty) CMS Refine ment (min or qty) Comment

L047

B REEGT NF Provide preservice education/obtai n consent 5 3 CMS clinical review

L047

B REEGT NF Other Clinical Activity - specify: Set up and calibrate all monitoring and recording equipment (initial), including capnograph (for child) 6 5 CMS clinical review

L047

B REEGT NF Other Clinical Activity - specify: Measure and mark head and face. Apply and secure electrodes to head and face. Check impedances. Reapply electrodes as needed. (1.5 min per electrode for child, 1 min per electrode for adult) 30 20 CMS clinical review

L047

B REEGT NF Other Clinical Activity - specify: Apply recording devices forcardiorespiratory, leg movements, body positioning and snoring 0 15 CMS clinical review690

CPT Code CPT Code Description CMS Code CMS Code Description NonFac / Fac Labor Activity (if applicable) AMA RUC Recomme ndation or

Current

Value (min or

qty) CMS Refine ment (min or qty) Comment

L047

B REEGT NF Other Clinical Activity - specify: Apply recording devices forcardiorespiratory, leg movements, body positioning, snoring and capnography 20 0 CMS clinical review

L047

B REEGT NF Other Clinical Activity - specify: Daytime tech reviews and edits recording, marks artifacts, scores sleep stages, performs evaluation of physiological changes 100 97 CMS clinical review

EF02

3 table, exam NF 44 41 Refined equipment time to reflect typical use exclusive to patient

EQ0

24 EMG-NCV-EP system, 8 channel NF 44 41 Refined equipment time to reflect typical use exclusive to patient 95861 Muscle test 2 limbs

L037 D RN/LPN/MTA NF Assist physician in performing procedure 19 29 Conformi ng to physician time691

CPT Code CPT Code Description CMS Code CMS Code Description NonFac / Fac Labor Activity (if applicable) AMA RUC Recomme ndation or

Current

Value (min or

qty) CMS Refine ment (min or qty) Comment

EF02

3 table, exam NF 58 52 Refined equipment time to reflect typical use exclusive to patient 95863 Muscle test 3 limbs

EQ0 24 EMG-NCV-EP system, 8 channel NF 58 52 Refined equipment time to reflect typical use exclusive to patient

EF02

3 table, exam NF 71 62 Refined equipment time to reflect typical use exclusive to patient 95864 Muscle test 4 limbs

EQ0 24 EMG-NCV-EP system, 8 channel NF 71 62 Refined equipment time to reflect typical use exclusive to patient

EF02

3 table, exam NF 27 22 Refined equipment time to reflect typical use exclusive to patient 95865 Muscle test larynx

EQ0 24 EMG-NCV-EP system, 8 channel NF 27 22 Refined equipment time to reflect typical use exclusive to patient692

CPT Code CPT Code Description CMS Code CMS Code Description NonFac / Fac Labor Activity (if applicable) AMA RUC Recomme ndation or

Current

Value (min or

qty) CMS Refine ment (min or qty) Comment

EF02

3 table, exam NF 35 32 Refined equipment time to reflect typical use exclusive to patient 95868 Muscle test cran nerve bilat
EQ0 24 EMG-NCV-EP system, 8 channel NF 35 32 Refined equipment time to reflect typical use exclusive to patient SG05

1 gauze, non-sterile 4in x 4in NF 0 4 CMS clinical review SG05

5 gauze, sterile 4in x 4in NF 4 0 CMS clinical review SG07

9 tape, surgical paper 1in (Micropore) NF 12 0 CMS clinical review 95907 Motor&/sen s 1-2 nrv cndj tst

SJ02 2 electrode skin prep gel (NuPrep) NF 100 0 CMS clinical review SG05

1 gauze, non-sterile 4in x 4in NF 0 8 CMS clinical review SG05

5 gauze, sterile 4in x 4in NF 8 0 CMS clinical review SG07

9 tape, surgical paper 1in (Micropore) NF 24 0 CMS clinical review 95908 Motor&/sen s 3-4 nrv cndj tst

SJ02 2 electrode skin prep gel (NuPrep) NF 100 0 CMS clinical review SG05

1 gauze, non-sterile 4in x 4in NF 0 12 CMS clinical review SG05

5 gauze, sterile 4in x 4in NF 12 0 CMS clinical review 95909 Motor&/sen s 5-6 nrv cndj tst

SG07 9 tape, surgical paper 1in (Micropore) NF 36 0 CMS clinical review693

CPT Code CPT Code Description CMS Code CMS Code Description NonFac / Fac Labor Activity (if applicable) AMA RUC Recomme ndation or

Current

Value (min or

qty) CMS Refine ment (min or qty) Comment

SJ02

2 electrode skin prep gel (NuPrep) NF 100 0 CMS clinical review
L037

A Electrodiagnostic Technologist NF 50 40 Conformi ng to physician time SG05

1 gauze, non-sterile 4in x 4in NF 0 16 CMS clinical review SG05

5 gauze, sterile 4in x 4in NF 16 0 CMS clinical review SG07

9 tape, surgical paper 1in (Micropore) NF 48 0 CMS clinical review 95910 Motor&sen s 7-8 nrv cndj test

SJ02 2 electrode skin prep gel (NuPrep) NF 100 0 CMS clinical review
L037

A Electrodiagnostic Technologist NF 64 50 Conformi ng to physician time SG05

1 gauze, non-sterile 4in x 4in NF 0 20 CMS clinical review SG05

5 gauze, sterile 4in x 4in NF 20 0 CMS clinical review SG07

9 tape, surgical paper 1in (Micropore) NF 60 0 CMS clinical review 95911 Motor&sen 9-10 nrv cndj test

SJ02 2 electrode skin prep gel (NuPrep) NF 100 0 CMS clinical review
L037

A Electrodiagnostic Technologist NF 77 60 Conformi ng to physician time SG05

1 gauze, non-sterile 4in x 4in NF 0 24 CMS clinical review SG05

5 gauze, sterile 4in x 4in NF 24 0 CMS clinical review 95912 Motor&sen 11-12 nrv cnd test

SG07 9 tape, surgical paper 1in (Micropore) NF 72 0 CMS clinical review694

CPT Code CPT Code Description CMS Code CMS Code Description NonFac / Fac Labor Activity (if applicable) AMA RUC Recomme ndation or

Current

Value (min or

qty) CMS Refine ment (min or qty) Comment

SJ02

2 electrode skin prep gel (NuPrep) NF 100 0 CMS clinical review
L037

A Electrodiagnostic Technologist NF 87 70 Conformi ng to physician time SG05

1 gauze, non-sterile 4in x 4in NF 0 26 CMS clinical review SG05

5 gauze, sterile 4in x 4in NF 26 0 CMS clinical review SG07

9 tape, surgical paper 1in (Micropore) NF 78 0 CMS clinical review 95913 Motor&sen s 13/> nrv

cnd test

SJ02 2 electrode skin prep gel (NuPrep) NF 100 0 CMS clinical review

EF03

2 table, tilt (wtrendelenberg) NF 64 55 Refined equipment time to reflect typical use exclusive to patient

EQ0

51 arterial tonometry acquisition system (WR Testworks) NF 64 55 Refined equipment time to reflect typical use exclusive to patient

EQ0

52 arterial tonometry monitor (Colin Pilot) NF 64 55 Refined equipment time to reflect typical use exclusive to patient 95921 Autonomic nrv parasym inervj

L037 A Electrodiagnostic Technologist NF Greet patient, provide gowning, assure appropriate medical records are available 3 0 CMS clinical review695

CPT Code CPT Code Description CMS Code CMS Code Description NonFac / Fac Labor Activity (if applicable) AMA RUC Recomme ndation or

Current

Value (min or

qty) CMS Refine ment (min or qty) Comment

L037

A Electrodiagnostic Technologist NF Obtain vital signs 3 0 CMS clinical review

L037

A Electrodiagnostic Technologist NF Monitor pt. following service/check tubes, monitors, drains 5 2 CMS clinical review

EF03

2 table, tilt (wtrendelenberg) NF 79 70 Refined equipment time to reflect typical use exclusive to patient

EQ0

51 arterial tonometry acquisition system (WR Testworks) NF 79 70 Refined equipment time to reflect typical use exclusive to patient

EQ0

52 arterial tonometry monitor (Colin Pilot) NF 79 70 Refined equipment time to reflect typical use exclusive to patient

L037

A Electrodiagnostic Technologist NF Greet patient, provide gowning, assure appropriate medical records are available 3 0 CMS clinical review

L037

A Electrodiagnostic Technologist NF Obtain vital signs 3 0 CMS clinical review 95922 Autonomic nrv adrenrg inervj

L037 A Electrodiagnostic Technologist NF Monitor pt. following service/check tubes, monitors, drains 5 2 CMS clinical review696

CPT Code CPT Code Description CMS Code CMS Code Description NonFac / Fac Labor Activity (if applicable) AMA RUC Recomme ndation or

Current

Value (min or

qty) CMS Refine ment (min or qty) Comment

EQ0

35 QSART acquisition system (Q-Sweat) NF 74 61 Refined equipment time to reflect typical use exclusive to patient

EQ1

24 stimulator, constant current, w-stimulating and grounding electrodes (Grass Telefactor) NF 74 61 Refined equipment time to reflect typical use exclusive to patient

EQ1

71 light, infra-red, ceiling mount NF 74 61 Refined equipment time to reflect typical use exclusive to patient L037

A Electrodiagnostic Technologist NF Assist physician in performing procedure 55 45 CMS clinical review

L037

A Electrodiagnostic Technologist NF Monitor pt. following service/check tubes, monitors, drains 5 2 CMS clinical review 95923 Autonomic nrv syst funj test

SJ02 0 electrode conductive gel NF 5 0 CMS clinical review

95924 Ans parasymp & symp w/tilt EF03 2 table, tilt (wtrendelenberg) NF 79 76 Refined equipment time to reflect typical use exclusive to patient697

CPT Code CPT Code Description CMS Code CMS Code Description NonFac / Fac Labor Activity (if applicable) AMA RUC Recomme ndation or

Current

Value (min or

qty) CMS Refine ment (min or qty) Comment

EQ0

51 arterial tonometry acquisition system (WR Testworks) NF 79 76 Refined equipment time to reflect typical use exclusive to patient

EQ0

52 arterial tonometry monitor (Colin Pilot) NF 79 76 Refined equipment time to reflect typical use exclusive to patient

L037

A Electrodiagnostic Technologist NF Monitor pt. following service/check tubes, monitors, drains 5 2 CMS clinical review

EF03

1 table, power NF 20 26 Refined equipment time to reflect typical use exclusive to patient

EQ1

61 laser, excimer NF 20 26 Refined equipment time to reflect typical use exclusive to patient

EQ1

68 light, exam NF 17 26 Refined equipment time to reflect typical use exclusive to patient 96920 Laser tx skin < 250

sq cm

L037 D RN/LPN/MTA NF Monitor pt. following service/check tubes, monitors, drains 3 1 CMS clinical review698

CPT Code CPT Code Description CMS Code CMS Code Description NonFac / Fac Labor Activity (if applicable) AMA RUC Recomme ndation or

Current

Value (min or

qty) CMS Refine ment (min or qty) Comment

L037

D RN/LPN/MTA NF Clean room/equipment by physician staff 3 2 CMS clinical review
SF02

8 laser tip (single use) NF 1 0 CMS clinical review SJ02

9 ice pack, instant NF 4 1 CMS Code correction

EF03

1 table, power NF 23 29 Refined equipment time to reflect typical use exclusive to patient

EQ1

61 laser, excimer NF 23 29 Refined equipment time to reflect typical use exclusive to patient

EQ1

68 light, exam NF 23 29 Refined equipment time to reflect typical use exclusive to patient

L037

D RN/LPN/MTA NF Monitor pt. following service/check tubes, monitors, drains 3 1 CMS clinical review

L037

D RN/LPN/MTA NF Clean room/equipment by physician staff 3 2 CMS clinical review
SF02

8 laser tip (single use) NF 1 0 CMS clinical review 96921 Laser tx skin 250- 500 sq cm

SJ02 9 ice pack, instant NF 4 2 CMS Code correction699

CPT Code CPT Code Description CMS Code CMS Code Description NonFac / Fac Labor Activity (if applicable) AMA RUC Recomme ndation or

Current

Value (min or

qty) CMS Refine ment (min or qty) Comment

EF03

1 table, power NF 33 39 Refined equipment time to reflect typical use exclusive to patient

EQ1

61 laser, excimer NF 33 39 Refined equipment time to reflect typical use exclusive to patient

EQ1

68 light, exam NF 30 39 Refined equipment time to reflect typical use exclusive to patient

L037

D RN/LPN/MTA NF Monitor pt. following service/check tubes, monitors, drains 3 1 CMS clinical review

L037

D RN/LPN/MTA NF Clean room/equipment by physician staff 3 2 CMS clinical review 96922 Laser tx skin >500

sq cm

SF02 8 laser tip (single use) NF 1 0 CMS clinical review

EQ2

48 ultrasonic biometry, pachymeter NF 10 5 Refined equipment time to reflect typical use exclusive to patient 97150 Group therapeutic procedures

EQ2 69 blood pressure monitor,ambulatory, wbattery charger NF 1 0 CMS clinical review700

CPT Code CPT Code Description CMS Code CMS Code Description NonFac / Fac Labor Activity (if applicable) AMA RUC Recomme ndation or

Current

Value (min or

qty) CMS Refine ment (min or qty) Comment

SA00

7 kit, cooking activityingredients (maccheese) NF 1 0 CMS clinical review

99495 Trans care mgmt 14 day disch L042 A RN/LPN F communication (with patient, family members, guardian or caretaker, surrogate decision makers, and/or other professionals) regarding aspects of care, etc. 0 45 CMS clinical review

NF 60 70 CMS clinical review

99496 Trans care mgmt 7 day disch L042 A RN/LPN

F communication (with patient, family members, guardian or caretaker, surrogate decision makers, and/or other professionals) regarding aspects of care, etc. 0 70 CMS clinical review701
c. Establishing CY 2013 Interim Final Malpractice Crosswalks According to our malpractice methodology disc ussed in section III.C.1 of this CY 2013 PFS final rule with comment period, we have as signed malpractice RVUs for CY 2013 new and revised codes by utilizing a crosswalk to a source code with a si milar malpractice risk-of-service. We have reviewed the AMA RUC-recommended ma lpractice source code crosswalks for CY 2013 new and revised codes, and we are accepting all of them on an interim final basis for CY
2013. For CY 2013, we created several HCPCS G-codes. HCPCS code G0452 (Molecular pathology procedure; physician interpretation an d report) was created to replace CPT code 83912 (Molecular diagnostics; in terpretation and report), which is deleted effective January 1, 2013. We believe CPT code 83912 has a similar malpr actice risk-of-service as HCPCS code G0452. Therefore, we are assigning an interim final malpractice crosswalk of CPT code 83912 to HCPCS code G0452 on an interim final basis for CY 2013. For CY 2013, we created HCPCS c ode G0453 (Continuous intraoperative neurophysiology monitoring, from outside the operat ing room (remote or nearby), per patient, (attention directed exclusively to one patient ), each 15 minutes) to replace new CPT code 95941 (Continuous intraoperative ne urophysiology monitoring, from outside the operating room (remote or nearby) or for monitoring of more than one case while in the operating room, per hour) which will have a PFS procedure status indicat or of I (Not valid for Medicare purposes. Medicare uses another code for the reporting of and the payment for these services) for CY 2013, as discussed in section III.M.3.a. of this CY 2013 PFS final rule with comment period. The AMA RUC recommended a malpractice cro sswalk of CPT code 95920 (Intraoperative neurophysiology testing, per hour (Lis t separately in addition to c ode for primary procedure)) for CPT code 95941. We believe CPT code 95920 has a similar malpractice risk-of-service as702 HCPCS code G0453. Therefore, we are assigning an interim final malpr actice crosswalk of CPT code 95920 to HCPCS code G0453 for CY 2013. For CY 2013, we created HCPCS code G0454 (Physician documentati on of face-to- face visit for Durable Medical Equipment determination performed by Nurse Practitioner, Physician Assistant or Clinical Nurse Speci alist) for payment to a physicia n who documents that a PA, NP, or CNS practitioner has performe d a face-to-face encounter for the list of specified DME covered items. As discussed in secti on IV.C. of this CY 2013 PFS final rule with comment period, we have assigned HCPCS code G0454 a work RVU of 0.18, which is a crosswalk to CPT code 99211 (Level 1 office or other outpatient visit, established patient). We believe CPT code 99211 has a similar malpractice risk-of-service as HC PCS code G0454. Therefore, we are assigning an interim final malpractice crosswalk of CP T code 99211 to HCPCS code G0454 for CY 2013. For CY 2013, we created HCPCS code G0455 (Preparation with instillation of fecal microbiota by any method, including assessmen t of donor specimen) to replace new CPT code 44705 (Preparation of fecal microbiota for instil lation, including assessment of donor specimen) which will have a PFS procedure status indica tor of I (Not valid for Medicare purposes. Medicare uses another code for the reporting of and the payment for these services) for CY 2013, as discussed in section III.M.3.a. of this CY 2013 PFS final rule with comment period. The AMA RUC recommended a malpractice crossw alk of CPT code 91065 (Breath hydrogen test (eg, for detection of lactase deficiency, fructose intolerance, bacterial ov ergrowth, or oro-cecal gastrointestinal transit) for CPT code 44705. We believe CPT code 91065 has a similar malpractice risk-of-service as HCPCS code G0455. Therefore, we are as signing an interim final malpractice crosswalk of CPT code 91065 to HCPCS code G0455 for CY 2013. In accordance with our malpractice met hodology, we have adjusted the malpractice RVUs of the CY 2013 new/revised codes for the di fference in work RVUs (or, if greater, the703 clinical labor portion of the fully implemente d PE RVUs) between th e source code and the new/revised codes to reflect the sp ecific risk-of-service for the ne w/revised codes. Table 75 lists the CY 2012 new/revised HCPCS codes and their re spective source codes used to set the interim final CY 2013 malpractice RVUs. Revised CPT code s that are crosswalked to themselves (that is, CPT code 11300 to 11300) are not listed. Th e malpractice RVUs for these services are reflected in Addendum B of this CY 2013 PFS fi nal rule with comment period. TABLE 75: Malpractice Crosswalks for CY 2013 New/Revised Codes Used to Establish Malpractice RVUs CY 2013 New, Revised, or Potentially Misvalued HCPCS Code Malpractice Risk Factor Crosswalk HCPCS Code 22586 Prescrl fuse w/ instr l5/s1 22558 Lumbar spine fusion 23473 Revis reconst shoulder joint 23472 Reconstruct shoulder joint 23474 Revis reconst shoulder joint 23210 Resect scapula tumor 24370 Revise reconst elbow jo int 24363 Repl ace elbow joint 24371 Revise reconst elbow jo int 24363 Repl ace elbow joint 31647 Bronchial valve init insert 31636 Bronchoscopy bronch stents 31648 Bronchial valve addl insert 31638 Bronchoscopy revise stent 31649 Bronchial valve remov init 31637 Bronchoscopy stent add-on 31651 Bronchial valve remov addl 31637 Bronchoscopy stent add-on 31660 Bronch thermoplsty 1 lobe 31636 Bronchoscopy bronch stents 31661 Bronch thermoplsty 2/> lobes 31638 Bronchoscopy revise stent 32551 Insertion of chest tube 19260 Removal of chest wall lesion 32554 Aspirate pleura w/o imaging 32421 Thoracentesis for aspiration 32555 Aspirate pleura w/ imaging 32422 Thoracentesis w/tube insert 32556 Insert cath pleura w/o image 32422 Thoracentesis w/tube insert 32557 Insert cath pleura w/ image 32551 Insertion of chest tube 32701 Thorax stereo rad targetw/tx 33468 Revision of tricuspid valve 33361 Replace aortic valve perq 3388 0 Endovasc taa repr incl subcl 33362 Replace aortic valve open 3388 0 Endovasc taa repr incl subcl 33363 Replace aortic valve open 3388 0 Endovasc taa repr incl subcl 33364 Replace aortic valve open 3388 0 Endovasc taa repr incl subcl 33365 Replace aortic valve open 3 3979 Insert intrac orporeal device 33367 Replace aortic valve w/byp 3 3979 Insert intrac orporeal device 33368 Replace aortic valve w/byp 3 3979 Insert intrac orporeal device 33369 Replace aortic valve w/byp 33305 Repair of heart wound 33990 Insert vad artery access 3324 0 Insrt pulse gen w/singl lead 33991 Insert vad art&vein access 33240 Insrt pulse gen w/singl lead 33992 Remove vad different session 33240 Insrt pulse gen w/singl lead 33993 Reposition vad diff session 33240 Insrt pulse gen w/singl lead 36221 Place cath thoracic aorta 36200 Place catheter in aorta 36222 Place cath carotid/inom art 36216 Place catheter in artery 36223 Place cath carotid/inom art 36216 Place catheter in artery 36224 Place cath carotd art 36217 Place catheter in artery 36225 Place cath subclavian art 36215 Place catheter in artery704

CY 2013 New, Revised, or Potentially Misvalued HCPCS Code Malpractice Risk Factor Crosswalk HCPCS Code 36226 Place cath vertebral art 36217 Place catheter in artery 36227 Place cath xtrnl carotid 36218 Place catheter in artery 36228 Place cath intracranial art 36218 Place catheter in artery 37197 Remove intrvas foreign body 37183 Remove hepatic shunt (tips) 37211 Thrombolytic art therapy 37184 Prim art mech thrombectomy 37212 Thrombolytic venous therapy 37184 Prim art mech thrombectomy 37213 Thromblytic art/ven therapy 37184 Prim art mech thrombectomy 37214 Cessj therapy cath removal 37184 Prim art mech thrombectomy 38243 Transplj hematopoietic boost 38242 Lymphocyte infuse transplant 52287 Cystoscopy chemodenervation 51715 Endoscopic injection/implant 64615 Chemodenerv musc migraine 64612 Destroy nerve face muscle 78012 Thyroid uptake measurement 78000 Thyroid single uptake 78013 Thyroid imaging w/blood flow 78010 Thyroid imaging 78014 Thyroid imaging w/blood flow 78007 Thyroid image mult uptakes 78071 Parathyrd planar w/wo subtrj 78803 Tumor imaging (3D) 78072 Parathyrd planar w/spect&ct 78452 Ht muscle image spect mult 86153 Cell enumeration phys interp 88361 Tumor immunohistochem/comput 90785 Psytx complex interactive 90846 Family psytx w/o patient 90791 Psych diagnostic evaluation 90846 Family psytx w/o patient 90792 Psych diag eval w/med srvcs 90846 Family psytx w/o patient 90832 Psytx pt&/family 30 minutes 90846 Family psytx w/o patient 90833 Psytx pt&/fam w/e&m 30 min 90846 Family psytx w/o patient 90834 Psytx pt&/family 45 minutes 90846 Family psytx w/o patient 90836 Psytx pt&/fam w/e&m 45 min 90846 Family psytx w/o patient 90837 Psytx pt&/family 60 minutes 90846 Family psytx w/o patient 90838 Psytx pt&/fam w/e&m 60 min 90846 Family psytx w/o patient 91112 Gi wireless capsule measure 91110 Gi tract capsule endoscopy 92920 Prq cardiac angioplast 1 art 92982 Coronary artery dilation 92921 Prq cardiac angio addl art 92984 Coronary artery dilation 92924 Prq card angio/athrect 1 art 92995 Coronary atherectomy 92925 Prq card angio/athrect addl 92995 Coronary atherectomy 92928 Prq card stent w/angio 1 vsl 92980 Insert intracoronary stent 92929 Prq card stent w/angio addl 92981 Insert intracoronary stent 92933 Prq card stent/ath/angio 92980 Insert intracoronary stent 92934 Prq card stent/ath/angio 92981 Insert intracoronary stent 92937 Prq revasc byp graft 1 vsl 92980 Insert intracoronary stent 92938 Prq revasc byp graft addl 92981 Insert intracoronary stent 92941 Prq card revasc mi 1 vsl 92980 Insert intracoronary stent 92943 Prq card revasc chronic 1vsl 92980 Insert intracoronary stent 92944 Prq card revasc chronic addl 92981 Insert intracoronary stent 93653 Ep & ablate supravent arrhyt 93620 Electrophysiology evaluation 93654 Ep & ablate ventric tachy 93620 Electrophysiology evaluation 93655 Ablate arrhythmia add on 93620 Electrophysiology evaluation 93656 Tx atrial fib pulm vein isol 93620 Electrophysiology evaluation 93657 Tx l/r atrial fib addl 93620 Electrophysiology evaluation 95017 Perq & icut allg test venoms 95010 Percut allergy titrate test 95018 Perq&ic allg test drugs/biol 95010 Percut allergy titrate test 95076 Ingest challenge ini 120 min 95180 Rapid desensitization705

CY 2013 New, Revised, or Potentially Misvalued HCPCS Code Malpractice Risk Factor Crosswalk HCPCS Code 95079 Ingest challenge addl 60 min 95180 Rapid desensitization 95782 Polysom <6 yrs 4/> paramtrs 95810 Polysomnography 4 or more 95783 Polysom <6 yrs cpap/bilvl 95811 Polysomnography w/cpap 95907 Motor&/sens 1-2 nrv cndj tst 95904 Sense nerve conduction test 95908 Motor&/sens 3-4 nrv cndj tst 95904 Sense nerve conduction test 95909 Motor&/sens 5-6 nrv cndj tst 95904 Sense nerve conduction test 95910 Motor&sens 7-8 nrv cndj test 95904 Sense nerve conduction test 95911 Motor&sen 9-10 nrv cndj test 95904 Sense nerve conduction test 95912 Motor&sen 11-12 nrv cnd test 95904 Sense nerve conduction test 95913 Motor&sens 13/> nrv cnd test 95904 Sense nerve conduction test 95921 Autonomic nrv parasym inervj 95923 Autonomic nerv function test 95922 Autonomic nrv adrenrg inervj 95923 Autonomic nerv function test 95924 Ans parasymp & symp w/tilt 95923 Autonomic nerv function test 95940 Ionm in operatng room 15 min 95920 Intraop nerve test add-on 99485 Suprv interfacilty transport 99471 Ped critical care initial 99486 Suprv interfac trnsport addl 99472 Ped critical care subsq 99487 Cmplx chron care w/o pt vsit 99374 Home health care supervision 99488 Cmplx chron care w/ pt vsit 99215 Office/outpatient visit est 99489 Complx chron care addl30 min 99374 Home health care supervision 99495 Trans care mgmt 14 day disch 99214 Office/outpatient visit est 99496 Trans care mgmt 7 day disch 99215 Office/outpatient visit est G0452 Molecular pathology interpr 83912 Genetic examination G0453 Cont intraop neuro monitor 95920 Intraop nerve test add-on G0454 MD document visit by NPP 99211 Office/outpatient visit est G0455 Fecal microbiota prep in stil 91065 Breath hydrogen test706 N. Allowed Expenditures for Physicians' Services and the Sustainable Growth Rate 1. Medicare Sustainable Growth Rate (SGR) The SGR is an annual growth ra te that applies to physicians’ services paid by Medicare. The use of the SGR is intended to control gr owth in aggregate Medi care expenditures for physicians’ services. Payments for services are not withheld if the percentage increase in actual expenditures exceeds the SGR. Rather, the PFS upda te, as specified in section 1848(d)(4) of the Act, is adjusted based on a comparison of allo wed expenditures (determined using the SGR) and actual expenditures. If actual expenditures exc eed allowed expenditures, the update is reduced. If actual expenditures are le ss than allowed expenditures, the update is increased. Section 1848(f)(2) of the Act sp ecifies that the SGR for a year (beginning with CY 2001) is equal to the product of the following four factors: (1) The estimated change in fees for physicians' services; (2) The estimated change in the av erage number of Medicare fee-for-service beneficiaries; (3) The estimated projected grow th in real GDP per capita; and (4) The estimated change in expenditures due to changes in st atute or regulations. In general, section 1848(f)(3) of the Act requires us to publish SGRs for 3 different time periods, no later than November 1 of each year, us ing the best data available as of September 1 of each year. Under section 1848(f)(3)(C)(i) of th e Act, the SGR is estimated and subsequently revised twice (beginning with the FY and CY 2000 SGRs) based on later data. (The Act also provides for adjustments to be made to the SGRs for FY 1998 and FY 1999. See the February 28, 2003 Federal Register (68 FR 9567) for a discussi on of these SGRs). Under section 1848(f)(3)(C)(ii) of the Act, there are no further revisions to the SGR once it has been estimated and subsequently revised in each of the 2 years following the preliminary estimate. In707 this final rule with comment, we are making our preliminary estimate of the CY 2013 SGR, a revision to the CY 2012 SGR, and our fi nal revision to the CY 2011 SGR. a. Physicians’ Services Section 1848(f)(4)(A) of the Ac t defines the scope of physicians’ services covered by the SGR. The statute indicates that “the term physic ians’ services includes other items and services (such as clinical diagnostic labo ratory tests and radi ology services), specif ied by the Secretary, that are commonly performed or furnished by a p hysician or in a physician's office, but does not include services furnished to a Medicare+Choice plan enrollee.” We published a definition of physicians’ services for use in the SGR in the November 1, 2001 Federal Register (66 FR 55316). We defined physicians’ services to include many of the medical and other health services li sted in section 1861(s) of the Act. Since that time, the statute has been amended to add new Me dicare benefits. As the statute changed, we modified the definition of physicians’ services for the SGR to include the additional benefits added to the statute that meet the crite ria specified in sec tion 1848(f)(4)(A). As discussed in the CY 2010 PFS final rule with comment period (74 FR 61961), the statute provides the Secretary with clear disc retion to decide whethe r physician-administered drugs should be included or excluded from the definition of “physicians’ services.” Accordingly, we removed physician-administer ed drugs from the definition of physicians’ services in section 1848(f)(4)(A) of the Act for purposes of computing the SGR and the levels of allowed expenditures and actual expenditures beginning with CY 2010, and for all subsequent years. Furthermore, in order to effectuate fu lly the Secretary’s policy decision to remove drugs from the definition of physicians’ services, we removed physician-administered drugs from the calculation of allowed a nd actual expenditures for all prior years.708 Thus, for purposes of determining allowed expe nditures, actual expend itures for all years, and SGRs beginning with CY 2010 and for all subse quent years, we specified that physicians’ services include the follo wing medical and other health services if bills for the items and services are processed and paid by Medi care carriers (and those paid through intermediaries where specified) or the equivalent services proce ssed by the Medicare Admini strative Contractors:

● Physicians’ services.

● Services and supplies furnished incident to physicians’ serv ices, except for the expenditures for drugs and biologicals which are not usually self-administered by the patient.

● Outpatient physical therapy services a nd outpatient occupationa l therapy services.

● Services of PAs, certifi ed registered nurse anesthet ists, certified nurse midwives, clinical psychologists, clinical so cial workers, nurse practitioners , and certified nurse specialists.

● Screening tests for prostate cancer, colorectal cancer, and glaucoma.

● Screening mammography, screening pap smears, and screening pelvic exams.

● Diabetes outpatient self-manag ement training (DSMT) services.

● MNT services.

● Diagnostic x-ray tests, di agnostic laboratory tests, and ot her diagnostic tests (including outpatient diagnostic laboratory test s paid through intermediaries).

● X-ray, radium, and radioactive isotope therapy.

● Surgical dressings, splints , casts, and other devices used for the reduction of fractures and dislocations.

● Bone mass measurements.

● An initial preventive physical exam.

● Cardiovascular sc reening blood tests.

● Diabetes screening tests.709

● Telehealth services.

● Physician work and resources to establish and document the need for a power mobility device.

● Additional prev entive services.

● Pulmonary rehabilitation.

● Cardiac rehabilitation.

● Intensive cardiac rehabilitation.

● Kidney disease education services.

● Personalized preven tion plan services. b. Preliminary Estimate of the SGR for 2013 Our preliminary estimate of the CY 2013 SGR is -19.7 percent. We first estimated the CY 2013 SGR in March 2012, and we made the es timate available to the MedPAC and on our website. Table 76 shows the March 2012 estimate and our current estimates of the factors included in the CY 2013 SGR. The majority of the difference between the March estimate and our current estimate of the CY 2013 SGR is explai ned by changes in estimated enrollment after our March estimate was prepared.
TABLE 76: CY 2013 SGR CALCULATION Statutory Factors March Estimate Current Estimate Fees 0.5 percent (1.005) 0.3 percent (1.003) Enrollment 5.1 percent (1.051) 3.6 percent (1.036) Real Per Capita GDP 0.7 pe rcent (1.007) 0.7 percent (1.007) Law and Regulation -23.6 perc ent (0.764) -23.3 percent (0.767) Total -18.7 percent (0.813) -19.7 percent (0.803) Note: Consistent with section 1848(f)(2) of the Ac t, the statutory factors are multiplied, not added, to produce the total (that is, 1.003_ x 1.036 x 1.007 x 0.767.= 0.803). A more detailed explanation of each figure is provided below in this final rule with comment period. c. Revised Sustainable Growth Rate for CY 2012710

Our current estimate of the CY 2012 SGR is 5.1 percent. Table 77 shows our preliminary estimate of the CY 2012 SGR that was published in the CY 2012 PFS final rule with comment period (76 FR 73269) and our current estimate. The majority of the difference between the preliminary estimate and our current estimate of the CY 2012 SGR is explained by adjustments to reflect intervening legisla tive changes that have occurred since publication of the CY 2012 final rule with comment period.
TABLE 77: CY 2012 SGR CALCULATION

Statutory Factors Estimate from CY 2012 Final Rule Current Estimate Fees 0.6 percent (1.006) 0.6 percent (1.006) Enrollment 3.5 percent (1.035) 1.6 percent (1.016) Real Per Capita GDP 0.6 pe rcent (1.006) 0.7 percent (1.007) Law and Regulation -20.7 pe rcent (0.793) 2.1 percent (1.021) Total -16.9 percent (0.831) 5.1 percent (1.051) Note : A more detailed explanation of each figure is provid ed in below in this final rule with comment period. d. Final Sustainable Growth Rate for CY 2011 The SGR for CY 2011 is 4.7 percent. Table 78 shows our preliminary estimate of the CY 2011 SGR from the CY 2011 PFS final rule with comment period, our revised estimate from the CY 2012 PFS final rule with comment period, and the final figures determined using the best available data as of September 1, 2012.
TABLE 78: CY 2011 SGR CALCULATION

Statutory Factors Estimate from CY 2010 Final Rule Estimate from CY 2011 Final Rule Final Fees 0.2 percent (1.002) 0.2 percent (1.002) 0.2 percent (1.002) Enrollment 2.4 percent (1.024) 1.8 percent (1.018) 1.0 percent (1.010) Real Per Capita GDP 0.7 percent (1.007) 0.6 percent (1.006) 0.6 percent (1.006) Law and Regulation -16.2 percent (0.838) 3.3 percent (1.033) 2.8 percent (1.028) Total -13.4 percent (0.866) 6.0 percent (1.060) 4.7 percent (1.047) Note : A more detailed explanation of each figure is prov ided below in this final rule with comment period. e. Calculation of CYs 2013, 2012, and 2011 Sustainable Growth Rates711 (1) Detail on the CY 2013 SGR All of the figures used to determine the CY 2013 SGR are estimates that will be revised based on subsequent data. Any differences betw een these estimates and the actual measurement of these figures will be included in future re visions of the SGR and allowed expenditures and incorporated into subsequent PFS updates. (a) Factor 1-- Changes in Fees for Physic ians’ Services (Before Applying Legislative Adjustments) for CY 2013 This factor is calculated as a weighted average of the CY 2013 changes in fees for the different types of services included in the de finition of physicians’ services for the SGR. Medical and other health servic es paid using the PFS are estimated to account for approximately 87.7 percent of total allowed ch arges included in the SGR in CY 2013 and are updated using the percent change in the MEI. As discussed in section C, the pe rcent change in the MEI for CY 2013 is 0.8 percent. Diagnostic laboratory test s are estimated to represent approximately 12.3 percent of Medicare allowed ch arges included in the SGR for CY 2013. Medicare payments for these tests are updated by the Consumer Price Index for Urba n Areas (CPI-U), which is 1.7 percent for CY 2013. Section 1833(h)(2)(A)(iv(l) of the Act requires that the CPI-U update applied to clinical laboratory tests be redu ced by a multi-factor productivity adjustment (MFP adjustment) and, for each of years 2011 thr ough 2015, by 1.75 percentage points (percentage adjustment). The MFP adjustment will not a pply in a year where the CPI-U is zero or a percentage decrease. Further, the application of the MFP adjustment shall not result in an adjustment to the fee schedule of less than zero for a year. However, the application of the percentage adjustment may result in an adjustme nt to the fee schedule be ing less than zero for a year and may result in payment rates for a y ear being less than such payment rates for the preceding year. The applicable productivity adjustment for CY 2013 is -0.9 percent. Adjusting712 the CPI-U update by the productivity adjustment results in a 0.8 percent (1.7 percent (CPI-U)– 0.9 percent (MFP adjustment) update for CY 2013. Additionally, the percentage reduction of 1.75 percent is applied for CYs 2011 through 2015, as discussed previously, and an additional adjustment of -2.0 percent specified in the Middle Class Tax Relief a nd Job Creation Act. Therefore, for CY 2013, diagnostic laboratory te sts will receive an update of -3.0 percent (rounded). Table 79 shows the weighted average of the MEI and laboratory price changes for
CY 2013.
TABLE 79: WEIGHTED-AVERAGE OF THE MEI AND LABORATORY PRICE CHANGES FOR CY 2013 Weight Update Physician 0.877 0.8% Laboratory 0.123 -3.0% Weighted-average 1.000 0.3%

We estimate that the weighted average incr ease in fees for physicians’ services in CY 2013 under the SGR (before applying any legisl ative adjustments) wi ll be 0.3 percent. (b) Factor 2-- The Percentage Change in the Average Number of Part B Enrollees from CY
2012 to CY 2013 This factor is our estimate of the percent change in the average number of fee-for-service enrollees from CY 2012 to CY 2013. Services fu rnished to Medicare Advantage (MA) plan enrollees are outside the scope of the SGR and are excluded from this estimate. We estimate that the average number of Medicare Part B fee-for-service enro llees will increase by 3.6 percent from CY 2012 to CY 2013. Table 80 illustrates how this figure was determined.
TABLE 80: AVERAGE NUMBER OF ME DICARE PART B FEE-FOR-SERVICE ENROLLEES FROM CY 2012 TO CY 2013 (EXCLUDING BENEFICIARIES ENROLLED IN MA PLANS)

CY 2012 CY 2013 Overall 46.560 million 48.136 million713

CY 2012 CY 2013 Medicare Advantage (MA) 13.545 million 13.935 million Net 33.016 million 34.201 million Percent Increase 3.6 percent

An important factor affecting fee-for-service enrollment is beneficiary enrollment in MA plans. Because it is difficult to estimate the size of the MA en rollee population before the start of a CY, at this time we do not know how actual en rollment in MA plans will compare to currentestimates. For this reason, the estimate may change substantially as actual Medicare fee-forservice enrollment for CY 2013 becomes known. (c) Factor 3-- Estimated Real Gross Dome stic Product Per Capita Growth in CY 2013 We estimate that the growth in real GDP per capita from CY 2012 to CY 2013 will be 0.7 percent (based on the annual growth in the 10 year moving average of real GDP per capita (2004 through 2013)). Our past experien ce indicates that there have also been changes in estimates of real GDP per capita growth made before the year begins and the actual ch ange in real GDP per capita growth computed after the year is comple te. Thus, it is possible that this figure will change as actual information on economic performance becomes available to us in CY 2013. (d) Factor 4-- Percentage Change in Expenditures for Physicians' Services Resulting From Changes in Statute or Regulations in CY 2013 Compared With CY 2012 The statutory and regulatory provisions that will affect expenditures in CY 2013 relative to CY 2012 are estimated to have an impact on expenditures of -23.3 percent. The impact is primarily due to the expiration of the physician f ee schedule update specif ied in statute for CY 2012 only. (2) Detail on the CY 2012 SGR A more detailed discussion of our revised estim ates of the four elements of the CY 2012 SGR follows.714 (a) Factor 1--Changes in Fees for Physicia ns' Services (Before Applying Legislative Adjustments) for CY 2012 This factor was calculated as a weighted-average of the CY 2012 changes in fees that apply for the different types of services included in the definition of physicians' services for the SGR in CY 2012. We estimate that services paid using the PFS account for approximate ly 90.3 percent of total allowed charges included in the SGR in CY 2012. These se rvices were updated using the CY 2012 percent change in the MEI of 0.6 percent. We estimate that diagnostic laboratory tests represent approximately 12.3 percen t of total allowed charges in cluded in the SGR in CY 2012. For CY 2012, diagnostic laborat ory tests received an update of 0.7 percent. Table 81 shows the weighted-average of th e MEI and laboratory price changes for
CY 2011. TABLE 81: WEIGHTED-AVERAGE OF THE MEI, AND LABORATORY PRICE CHANGES FOR CY 2012 Weight Update Physician 0.903 0.6 Laboratory 0.097 0.7 Weighted-average 1.000 0.6

After considering the elements describe d in Table 81, we estimate that the weighted-average increase in fees for physic ians' services in CY 2012 under the SGR was 0.6 percent. Our estimate of th is factor in the CY 2012 PFS fina l rule with comment period was 0.6 percent. (76 FR 73271). (b) Factor 2--The Percentage Change in the Average Number of Part B Enrollees from CY 2011
to CY 2012715 We estimate that the average number of Me dicare Part B fee-for-service enrollees (excluding beneficiaries enrolled in Medicare Advantage plans) increased by 1.6 percent in CY 2012. Table 82 illustrates how we determined this figure.
TABLE 82: AVERAGE NUMBER OF ME DICARE PART B FEE-FOR-SERVICE ENROLLEES FROM CY 2011 TO CY 2012 (EXCLUDING BENEFICIARIES ENROLLED IN MA PLANS)
2011 2012 Overall 44.879 million 46.560 million Medicare Advantage (MA) 12.382 million 13.545 million Net 32.498 million 33.016 million Percent Increase 1.6 percent

Our estimate of the 1.6 percent change in the number of fee-for-service enrollees, net of Medicare Advantage enrollment for CY 2012 co mpared to CY 2011, is different than our original estimate of an incr ease of 3.5 percent in the CY 2012 PFS final rule with comment period
. (76 FR 73271)
. While our current projection based on data from 8 months of CY 2012 differs from our original estimat e of 3.5 percent when we had no act ual data, it is still possible that our final estimate of this figure will be different once we have complete information on CY 2012 fee-for-service enrollment. (c) Factor 3--Estimated Real Gross Dome stic Product Per Capita Growth in CY 2012 We estimate that the growth in real GDP per capita will be 0.7 percent for CY 2012 (based on the annual growth in the 10-year movi ng average of real GDP per capita (2003 through 2012)). Our past experience indicates that th ere have also been differences between our estimates of real per capita GDP growth made prior to the year's end and the actual change in this factor. Thus, it is possible that this figure will change further as complete actual information on CY 2012 economic performance becomes available to us in CY 2013. (d) Factor 4--Percentage Change in Expend itures for Physicians' Services Resulting From Changes in Statute or Regulations in CY 2012 Compared With CY 2011716 The statutory and regulatory provisions that affected expenditures in CY 2012 relative to CY 2011 are estimated to have an impact on expend itures of 2.8 percent. This is primarily an effect of the statutory requirements surrounding the temporary physician fee schedule update in
CY 2012. (3) Detail on the CY 2011 SGR A more detailed discussion of our final revise d estimates of the four elements of the CY 2011 SGR follows. (a) Factor 1--Changes in Fees fo r Physicians' Services for CY 2011 This factor was calculated as a weighted av erage of the CY 2011 changes in fees that apply for the different types of services included in the definition of physicians' services for the SGR in CY 2011. We estimate that services paid under the PFS account for approximate ly 90.7 percent of total allowed charges included in the SGR in CY 2011. These se rvices were updated using the CY 2011 percent change in the MEI of 0.4 percent. We estimate that diagnostic laboratory tests represent approximately 9.3 percen t of total allowed charges in cluded in the SGR in CY 2011. For CY 2011, diagnostic laborat ory tests received an update of -1.8 percent. Table 83 shows the weighted-average of th e MEI and laboratory price changes for
CY 2011.
TABLE 83: WEIGHTED-AVERAGE OF THE MEI, LABORATORY, AND DRUG PRICE CHANGES FOR CY 2011 Weight Update Physician 0.907 0.4 Laboratory 0.093 -1.8Weightedaverage 1.00 0.2717 After considering the elements describe d in Table 83, we estimate that the weighted-average increase in fees for physicia ns' services in CY 2011 under the SGR (before applying any legislative adjustments) was 0.2 pe rcent. This figure is a final one based on complete data for CY 2011. (b) Factor 2--The Percentage Change in the Average Number of Part B Enrollees from CY 2010
to CY 2011 We estimate the change in the number of fee-for-service enrollees (excluding beneficiaries enrolled in MA pl ans) from CY 2010 to CY 2011 wa s 1.0 percent. Our calculation of this factor is based on complete data from CY 2011. Table 84 illustra tes the calculation of this factor.
TABLE 84: AVERAGE NUMBER OF MEDICARE PART B FROM CY 2010 TO CY 2011 (EXCLUDING BENEFICIARIES ENROLLED IN MA PLANS)
2010 2011 Overall 43.871 44.879 million Medicare Advantage (MA) 11.692 12.382 million Net 32.179 32.498 million Percent Change 1.0

(c) Factor 3--Estimated Real Gross Dome stic Product Per Capita Growth in CY 2011 We estimate that the growth in real per capita GDP was 0.6 percent in CY 2011 (based on the annual growth in the 10-y ear moving average of real GDP per capita (2002 through 2011)). This figure is a final one based on complete data for CY 2011. (4) Factor 4--Percentage Change in Expend itures for Physicians’ Services Resulting From Changes in Statute or Regulations in CY 2011 Compared With CY 2010 Our final estimate for the net impact on e xpenditures from the st atutory and regulatory provisions that affect expenditu res in CY 2011 relative to CY 2010 is 2.8 percent. This is718 primarily an effect of the statutory requirements surroundi ng the temporary physician fee schedule update in CY 2011. 2. The Update Adjustment Factor (UAF) Section 1848(d) of the Act pr ovides that the PFS update is equal to the product of the MEI and the UAF. The UAF is applied to make act ual and target expenditures (referred to in the statute as “allowed expenditures”) equal. As discussed previously, al lowed expenditures are equal to actual expenditures in a base period upda ted each year by the SGR. The SGR sets the annual rate of growth in allowed expenditures and is determined by a formula specified in section 1848(f) of the Act. a. Calculation under Current Law Under section 1848(d)(4)(B) of the Act, th e UAF for a year beginning with CY 2001 is equal to the sum of the following--

● Prior Year Adjustment Component . An amount determined by-- + Computing the difference (which may be positive or negative) between the amount of the allowed expenditures for physicians ’ services for the prior year (t he year prior to the year for which the update is being determined) and th e amount of the actual expenditures for those services for that year; + Dividing that difference by the amount of th e actual expenditures fo r those services for that year; and + Multiplying th at quotient by 0.75.

● Cumulative Adjustment Component . An amount determined by-- + Computing the difference (which may be positive or negative) between the amount of the allowed expenditures for physicians' services from April 1, 1996, through the end of the prior year and the amount of the act ual expenditures for those se rvices during that period;719 + Dividing that difference by act ual expenditures for those serv ices for the prior year as increased by the SGR for the year for wh ich the UAF is to be determined; and + Multiplying th at quotient by 0.33. Section 1848(d)(4)(E) of the Act requires the Secretary to recalculate allowed expenditures consistent with se ction 1848(f)(3) of the Act. As discussed previously, section 1848(f)(3) specifies that the SGR (and, in tur n, allowed expenditures) for the upcoming CY (CY 2013 in this case), the current CY (that is, CY 2012) and the preceding CY (that is, CY 2011) are to be determined on the basis of the best data available as of September 1 of the current year. Allowed expenditures for a year ge nerally are estimated initially and subsequently revised twice. The second revi sion occurs after the CY has e nded (that is, we are making the second revision to CY 2011 allowed expenditures in this final rule with comment). Table 85 shows the historical SGRs corre sponding to each period through CY 2013. Note that these figures have b een revised to reflect a correction to the historical clinical laboratory expenditure data.
TABLE 85: ANNUAL AND CUMUL ATIVE ALLOWED AND ACTUAL EXPENDITURES FOR PHYSICIANS' SERV ICES FROM APRIL 1, 1996 THROUGH THE END OF THE CURR ENT CALENDAR YEAR

Period Annual Allowed Expenditures ($ in billions) Annual Actual Expenditures ($ in billions) Cumulative Allowed Expenditures ($ in billions) Cumulative Actual Expenditures ($ in billions) FY/CY SGR

4/1/96-3/31/97 47.0 47.0 47.0 47.0 4/1/97-3/31/98 48.5 47.2 95.6 94.3 3.2% 4/1/98-3/31/99 50.6 48.1 146.2 142.4 4.2% 1/1/99-3/31/99 12.7 12.5 146.2 142.4 4/1/99-12/31/99 40.5 37.2 186.7 179.6 6.9% 1/1/99-12/31/99 53.2 49.7 186.7 179.6 1/1/00-12/31/00 57.1 54.4 243.7 234.0 7.3% 1/1/01-12/31/01 59.7 61.5 303.4 295.5 4.5% 1/1/02-12/31/02 64.6 64.8 368.0 360.3 8.3% 1/1/03-12/31/03 69.3 70.4 437.3 430.7 7.3% 1/1/04-12/31/04 73.9 78.5 511.2 509.1 6.6% 1/1/05-12/31/05 77.0 83.8 588.2 593.0 4.2% 1/1/06-12/31/06 78.2 85.1 666.4 678.1 1.5% 1/1/07-12/31/07 80.9 85.1 747.2 763.1 3.5% 1/1/08-12/31/08 84.5 87.3 831.8 850.4 4.5% 1/1/09-12/31/09 89.9 91.1 921.7 941.5 6.4%720

Period Annual Allowed Expenditures ($ in billions) Annual Actual Expenditures ($ in billions) Cumulative Allowed Expenditures ($ in billions) Cumulative Actual Expenditures ($ in billions) FY/CY SGR

1/1/10-12/31/10 97.9 96.0 1,019.6 1,037.4 8.9% 1/1/11-12/31/11 102.5 99.4 1,122.2 1,136.9 4.7% 1/1/12-12/31/12 107.8 102.0 1,230.0 1,238.9 5.1% (1) Allowed expenditures in the first year (April 1, 1996-March 31, 1997) are equal to actual expenditu res. All subsequent figure s are equal to quarterly allowed expenditure figures increas ed by the applicable SGR. Cumulative a llowed expenditures are equal to the sum of annual allowed expenditures. We provide more detailed quarterly allowed and actual expenditure data on our we bsite at the following address: http://www.cms.hhs.gov/Sust ainableGRatesConFact/ . We expect to update the website with th e most current information later this month. (2) Allowed expenditures for the first quart er of 1999 are based on the FY 1999 SGR. (3) Allowed expenditures for the last three quarters of 1999 are based on the FY 2000 SGR.
Consistent with section 1848(d )(4)(E) of the Act, Table 85 includes our second revision of allowed expenditures for CY 2011, a recalculation of allowed expenditures for CY 2012, and our initial estimate of allowed expenditures for CY 2013. To determine the UAF for CY 2013, the statute requires that we use allowed and actual expendit ures from April 1, 1996 through December 31, 2012 and the CY 2013 SGR. Consistent with section 1848(d)(4)(E) of the Act, we will be making further revisions to the CY 2012 and CY 2013 SGRs and CY 2012 and CY 2013 allowed expenditures. Because we have incomple te actual expenditure data for CY 2012, we are using an estimate for this period. Any difference between current estimates and final figures will be taken into account in determinin g the UAF for future years. We are using figures from Table 85 in the following statutory formula:



### 33

. 0 75

. 0

13 12 12 / 12 96 / 4 12 / 12 96 / 4

12 12 12 13 

### × × − + × −

− − = 

### SGR Actual Actual Target Actual Actual Target UAF

UAF 13 = Update Adjustment Factor for CY 2013 = 0.6 percent Target 12 = Allowed Expenditures for CY 2012 = $107.8 billion Actual 12 = Estimated Actual Expenditures for CY 2012 = $102.0 billion Target 4/96-12/12 = Allowed Expenditures from 4/ 1/1996 - 12/31/2012 = $1230.0 billion Actual 4/96-12/12 = Estimated Actual Expenditures fr om 4/1/1996 - 12/31/2012 = $1238.9 billion
SGR 13 = -19.7 percent (0.803)721

Section 1848(d)(4)(D) of the Act indicates that the UAF determined under section 1848(d)(4)(B) of the Act for a year may not be less than -0.07 or greater than 0.03. Since 0.006 (0.6 percent) is between -0.07 and 0.03, the UAF for CY 2013 will be 0.006. Section 1848(d)(4)(A)(ii ) of the Act indicates that 1.0 should be added to the UAF determined under section 1848(d)(4)(B) of th e Act. Thus, adding 1.0 to 0.006 yields 1.006. 3. The Percentage Change in th e Medicare Economic Index (MEI) The Medicare Economic Index (MEI) is re quired by section the fourth sentence of 1842(b)(3) of the Act, which stat es that prevailing charge le vels beginning after June 30, 1973 may not exceed the level from the previous year except to the extent that the Secretary finds, on the basis of appropriate economic index data, that the higher leve l is justified by year-to-year economic changes. The current form of the MEI was detailed in the CY 2011 PFS final rule with comment period (75 FR 73262) which updated the cost structure of the index from a base year of
2000 to 2006. The MEI measures the weighted-average annua l price change for various inputs needed to furnish physicians' services. The MEI is a fi xed-weight input price in dex, with an adjustment for the change in economy-wide multifactor productivity. This index, which has CY 2006 base year weights, is comprised of two broad categorie s: (1) physician's own time; and (2) physician's practice expense (PE). The physician's compensation (own time) comp onent represents the net income portion of business receipts and primarily reflects the input of the physician's own time into the production of physicians' services in physicians ' offices. This category consists of two subcomponents: (1) wages and salari es; and (2) fringe benefits. % 6

. 0 33

. 0 803

. 0 0

. 102 $ 9

. 1238 $ 0

. 1230 $ 75

. 0 0

. 102 $ 0

. 102 $ 8

. 107 $

= × × − + × −722 The physician's practice expense (PE) categor y represents nonphysician inputs used in the production of services in physicians' offices. This category consists of wages and salaries and fringe benefits for nonphys ician staff and other nonlabor inputs. The physician's PE component also includes the follo wing categories of nonlabor input s: office expenses; medical materials and supplies; professional liability in surance; medical equipment; medical materials and supplies; and other pr ofessional expenses. Table 86 presents a listing of the MEI cost ca tegories with associat ed weights and percent changes for price proxies for the 2013 update. The CY 2013 final MEI update is 1.8 percent and reflects a 1.9 percent in crease in physician’s own time and a 1.7 percent increase in physician’s PE. Within the physician’s PE, the largest incr ease occurred in chemicals, which increased 7.1 percent, and rubber and plastic produc ts, which increased 6.1 percent. For CY 2013, the increase in the MEI is 0.8 percent, which reflect s an increase in the non-productivity adjusted MEI of 1.8 percent and a productivity adjustment of 1.0 percent (which is based on the 10-year moving aver age of economy-wide private nonfarm business multifactor productivity). The Bureau of Labor Sta tistics (BLS) is the agency that publishes the official measure of private non-farm busine ss multi-factor productiv ity (MFP). Please see http://www.bls.gov/mfp/ , which is the link to the BLS hist orical published data on the measure of MFP.
TABLE 86: ANNUAL PERC ENT CHANGE IN THE REVI SED AND REBASED MEI CY 2013, ALL CATEGORIES Cost Categories 2006 Weight 2 CY 2013 Percent Changes MEI Total, productivity adjusted 100.000% 0.8 Productivity: 10-year mo ving average of MFP 1 N/A 5 1.0 MEI Total, without pro ductivity adjustment 100.000% 1.8

Physician Compensation (Own Time) 3 48.266% 1.9723
Cost Categories 2006 Weight 2 CY 2013 Percent Changes Wages and Salaries 43.880% 1.8 Benefits 4.386% 2.9 Practice Expenses 51.734% 1.7 Nonphysician Compensation 19.153% 1.9 Nonphysician Wages 13.\752% 1.7 P&T 6.006% 1.6 Management 1.446% 1.8 Clerical 4.466% 1.8 Services 1.834% 1.3 Nonphysician Benefits 5.401% 2.6 Other Practice Expenses 26.308% 1.6 Office Expenses 20.035% 2.0 Utilities 1.266% 1.5 Chemicals 0.723% 7.1 Paper 0.657% 1.9 Rubber & Plastics 0.598% 6.1 Telephone 1.501% -0.3 Postage 0.898% 3.6 All Other Services 3.582% 1.5 All Other Products 0.500% 2.1 Fixed Capital 8.957% 1.8 Moveable Capital 1.353% 1.5 PLI 4 4.295% 0.5 Medical Equipment 1.978% -0.6 Medical supplies 1.760% 0.5 Other Professional Expenses 4.513% 2.1

1 The forecasts are based upon the latest available Bureau of Labor Statistics data on the 10- year average of BLS private nonf arm business multifactor productivity published on June 26, 2012. (http://www.bls.gov/news.r elease/prod3.nr0.htm) 2 The weights shown for the MEI components are the 2006 base-year weights, which may not sum to subtotals or totals because of rounding. The MEI is a fixed-weight, Laspeyres-type input price index whose category weights indicate the distribution of expenditures am ong the inputs to physicians' services for CY 2006. To determine the MEI level for a given year, the price proxy level for each compon ent is multiplied by its 2006 weight. The sum of these products (wei ghts multiplied by the price index levels) overall cost categorie s yields the composite MEI level for a given year. The a nnual percent change in the MEI levels is an estimate of price change over time for a fixed market basket of inputs to physicians' services. 3 The measures of productivity, average hourly earnings, Employment Cost Indexes, as well as the various Producer and Consumer Price Indexes can be found on the Bureau of Labor Statistics Web site at http://stats.bls.gov

. 4 Derived from a CMS survey of several major commercial insurers. 5 Productivity is factored into the MEI categories as an adjust ment; therefore, no explicit weight exists for productivity in t he MEI. 4. Medicare Economic Index Technical Advisory Panel From May 2012 through September 2012, the ME I Technical Advisory Panel conducted a technical review of the MEI, including an alyses of the inputs, input weights, price-724 measurement proxies, and productivity adjustment . Details regarding the Panel’s work and documents such as transcripts, meeting summa ries, and presentations can be found at the following website: http://cms.gov/Regulations -and-Guidance/Guidance/FACA/MEITAP.html. The Panel concluded its public work on July 11, 2012 and submitted a final report complete with its recommendations to the Secret ary of Health and Human Services on August 27, 2012.
Comment : We received one comment requesting that CMS engage in dialogue with affected parties regarding the analyses and reco mmendations of the Technical Advisory Panel to the MEI prior to proposed rulemaking to implement any such findings. Response : The MEI Technical Advi sory Panel was chartered according to the Federal Advisory Committee Act. As a result, all of the Panel’s meetings were open to the public. In each meeting, including the final meeting where the Panel’s findings and recommendations were finalized, time was allotted to allow for any public comment. As we find appropriate, any recommended changes to the MEI will be proposed via the rulemaking process. Given the time made available for public comment during the ME I Technical Advisory Panel’s meetings, as well as the opportunity for public comment during rulemaking, we disagree with the commenter’s request that we e ngage in further dialogue prior to proposing possible changes. 5. Physician and Anesthesia Fee Schedule Conversion Factors for CY 2013 The CY 2013 PFS CF is $25.0008. The CY 2012 national average anesthesia CF is $15.93. a. Physician Fee Schedule U pdate and Conversion Factor (1) CY 2013 PFS Update The formula for calculating the PFS update is set forth in section 1848(d)(4)(A) of the Act. In general, the PFS update is determined by multiplying the CF for the previous year by the725 percentage increase in the MEI le ss productivity times the UAF, wh ich is calculated as specified under section 1848(d)(4)(B) of the Act. (2) CY 2013 PFS Conversion Factor Generally, the PFS CF for a year is calculat ed in accordance with section 1848(d)(1)(A) of the Act by multiplying the previous year’s CF by the PFS update. We note section 101 of the Medicare Improveme nts and Extension Act, Division B of the Tax Relief and Health Care Act of 2006 (MIEA- TRHCA) provided a 1-y ear increase in the CY 2007 CF and specified that the CF for CY 2008 must be computed as if the 1-year increase had never applied. Section 101 of the Medica re, Medicaid, and SCHI P Extension Act of 2007 (MMSEA) provided a 6-month increase in th e CY 2008 CF, from January 1, 2008, through June 30, 2008, and specified that the CF for the remain ing portion of CY 2008 and the CFs for CY 2009 and subsequent years must be computed as if the 6-month increase had never applied. Section 131 of the MIPPA extended the increase in the CY 2008 CF that applied during the first half of the year to the entir e year, provided for a 1.1 percent increase to the CY 2009 CF, and specified that the CFs for CY 2010 and subsequent years must be computed as if the increases for CYs 2007, 2008, and 2009 had never applied. Section 1011(a) of th e DODAA and section 5 of the TEA specified a zero percent update for CY 2010, effective January 1, 2010 through March 31, 2010. Section 4 of the Continuing Ex tension Act of 2010 (CEA) extended the zero percent update for CY 2010 through May 31, 2010. Subsequently, section 101(a)(2) of the PACMBPRA provided for a 2.2 percent update to the CF, effective from June 1, 2010 to November 30, 2010. Section 2 of the Physicia n Payment and Therapy Relief Act of 2010 (Pub. L. No. 111-286) extended the 2.2 percent thr ough the end of CY 2010. Section 101 of the MMEA provided a zero percen t update for CY 2011, effec tive January 1, 2011 through December 31, 2011, and specified that the CFs for CY 2012 and subsequent years must be726 computed as if the increases in previous year s had never applied. Section 301 of the Temporary Payroll Tax Cut Continuation Act of 2011 (TPTCC A) provided a zero per cent update effective January 1, 2012 through February 29, 2012, and speci fied that the CFs for subsequent time periods must be computed as if the increases in previous years had never applied. Section 3003 of the Middle Class Tax Relief and Job Creation Act of 2012 (Job Creation Act) provided a zero percent update for effective March 1, 2012 through December 31, 2012, and specified that the CFs for subsequent time periods must be comput ed as if the increases in previous years had never applied. Therefore, under cu rrent law, the CF that would be in effect in CY 2012 had the prior increases specified a bove not applied is $24.6712. In addition, when calculating the PFS CF for a year, section 1848(c)(2 )(B)(ii)(II) of the Act requires that increases or decreases in R VUs may not cause the amount of expenditures for the year to differ by more than $20 million from what it would have been in the absence of these changes. If this threshold is exceeded, we must make adjustment s to preserve budget neutrality. We estimate that CY 2012 RVU changes would resu lt in an increase in Medicare physician expenditures of more than $20 million. Accord ingly, we are decreasing the CF by -0.1% to offset the estimated increase in Medicare physician expenditures due to the CY 2012 RVU changes. We calculate the CY 2013 PFS CF to be $25.0008. This final rule with comment period announces a reduction to payment rates for physicians' services in CY 2013 under the SGR formula. These payment ra tes are currently scheduled to be reduced under the SGR system on January 1, 2013. The total reduction in the conversion factor betw een CY 2012 and CY 2013 under the SGR system will be -26.5 percent. By law, we are required to make these reductions in accordance with section 1848(d) and (f) of th e Act, and these reductions can only be averted by an Act of Congress. While Congress has prov ided temporary relief from these reductions every year since 2003, a long-term solution is critical . We will continue to work with Congress727

to fix this untenable situation so doctors and beneficiaries no longer have to worry about the stability and adequacy of their payments fr om Medicare under the Physician Fee Schedule. We illustrate the calculation of the CY 2013 PFS CF in Table 87.
TABLE 87: CALCULATION OF THE CY 2013 PFS CF Conversion Factor in e ffect in CY 2012 $34.0376 CY 2012 Conversion Factor had statutory increases not applied $24.6712 CY 2013 Medicare Economic Index 0.8 percent (1.008) CY 2013 Update Adjustment Factor 0.6 percent (1.006) CY 2013 RVU Budget Neutrality Ad justment -0.1 percent (0.99932) CY 2013 Conversion Factor $25.0008 Percent Change from Conversion Factor in

effect in CY 2012 to CY 2013 Conversion Factor -26.5%

We note payment for services under the PFS will be calculated as follows: Payment = [(RVU work x GPCI work) + (R VU PE x GPCI PE) + (RVU malpractice x GPCI malpractice)] x CF. b. Anesthesia Conversion Factor We calculate the anesthesia CF as indicated in Table 88. Anesthesia services do not have RVUs like other PFS services. Therefore, we account for any necessary RVU adjustments through an adjustment to the anesthesia CF to si mulate changes to RVUs. More specifically, if there is an adjustment to the work, PE, or malp ractice RVUs, these adjust ments are applied to the respective shares of the anesthesia CF as th ese shares are proxies for the work, PE, and malpractice RVUs for anesthesia services. Info rmation regarding the an esthesia work, PE, and malpractice shares can be found at the follo wing: https://www.cms.gov/center/anesth.asp.

The anesthesia CF in effect in CY 2012 is $21.52. As explained previously, in order to calculate the CY 2013 PFS CF, the st atute requires us to calculate the CFs for all previous years as if the various legislative changes to the CF s for those years had not occurred. Accordingly,728
under current law, the anes thesia CF in effect in CY 2012 had statutory increases not applied is $15.60. The percent change from the anesthesia CF in effect in CY 2012 to the CF for CY 2013 is –26.0 percent. We illustrate the calculati on of the CY 2013 anesthesia CF in Table 88.
TABLE 88: CALCULATION OF THE CY 2013 ANESTHESIA CF

2012 National Average Anesthesia Conversion Factor in effect in CY 2011 $21.52
2012 National Anesthesia Convers ion Factor had Statutory Increases Not Applied $15.60 CY 2013 Medicare Economic Index 0.8 percent (1.008) CY 2013 Update Adjustment Factor 0.6 percent (1.006) CY 2013 Budget Neutrality Work and Malpractice Adjustment -0.1 percent (0.99932) CY 2013 Anesthesia Fee Schedul e change due to Practice Expense 0.8 percent (1.008) CY 2013 Anesthesia Conversion Factor $15.93 Percent Change from 2012 to 2013 -26.0%

III. Other Provisions of the Fi nal Rule with Comment Period A. Ambulance Fee Schedule 1. Amendment to section 1834(l) (13) of the Act Section 146(a) of the Medicare Improvement s for Patients and Providers Act of 2008 (Pub. L. 110-275) (MIPPA) amended s ection 1834(l)(13)(A) of the Act to specify that, effective for ground ambulance services furnished on or af ter July 1, 2008 and before January 1, 2010, the ambulance fee schedule amounts for ground ambulan ce services shall be increased as follows:

● For covered ground ambulance transports that originate in a rura l area or in a rural census tract of a metropolitan st atistical area, the f ee schedule amounts shall be increased by 3 percent.

● For covered ground ambulance transports that do not originate in a rural area or in a rural census tract of a metropolitan statistical ar ea, the fee schedule amounts shall be increased729 by 2 percent. Sections 3105(a) and 10311(a) of the Affordable Care Act further amended section 1834(l)(13)(A) of the Act to extend the payment a dd-ons described above for an additional year, such that these add-ons also applied to c overed ground ambulance transports furnished on or after January 1, 2010 and before January 1, 2011 . In the CY 2011 PFS final rule (75 FR 73385 and 73386, 73625), we revised §414.610(c)(1)(ii) to c onform the regulations to this statutory requirement. Section 106(a) of the MMEA again amended section 1834(l)(13)(A) of the Act to extend the payment add-ons described above for an additi onal year, such that these add-ons also applied to covered ground ambulance transports furnis hed on or after January 1, 2011 and before January 1, 2012. In the CY 2012 End-Stage Rena l Disease Prospective Payment System (ESRD PPS) final rule (76 FR 70228, 70284 through 70285, 70315), we revised §414.610(c) (1) (ii) to conform the regulations to this statutory requirement. Howeve r, in doing so, paragraphs (c)(1)(ii)(A) and (B) were inadvertently deleted fro m the Code of Federal Regulations. Thus, in the proposed rule, we proposed to reinstate para graphs (c)(1)(ii)(A) and (B) as further revised below. We did not receive any comments on th is proposal. Therefore, we are finalizing our proposal to reinstate paragraphs (c)(1)(ii)(A) and (B), as further revised below to conform to subsequent legislation. Subsequently, section 306 (a ) of the Temporary Payroll Tax Cut Continuation Act of 2011 (Pub. L. 112-78) (TPTCCA) amended secti on 1834(l)(13)(A) of th e Act to extend the payment add-ons described above through Februa ry 29, 2012; and section 3007(a) of the Middle Class Tax Relief and Job Creation Act of 2012 (Pub. L. 112-96) (MCTRJCA) further amended section 1834(l)(13)(A) to extend these paym ent add-ons through December 31, 2012. Thus, these payment add-ons also apply to covered gr ound ambulance transports furnished on or after730 January 1, 2012 and before January 1, 2013. In the proposed rule, we proposed to revise §414.610(c)(1)(ii) to conform the regulations to thes e statutory requirements. We did not receive any comments on this proposal. Accordingly, we are finalizing our proposal to revise §414.610(c)(1)(ii) to conform to the statutory requ irements described above. These statutory requirements are self-implementing. A plain read ing of the statute requires only a ministerial application of the mandated rate increase, and does not require any substantive exercise of discretion on the part of the Secretary. 2. Amendment to sectio n 146(b) (1) of MIPPA Section 146(b) (1) of the MIPPA amended the designation of rural areas for payment of air ambulance services. This section originally specified that any area that was designated as a rural area for purposes of making payments unde r the ambulance fee schedule for air ambulance services furnished on December 31, 2006, must continue to be treated as a rural area for purposes of making payments under the ambulance fee sc hedule for air ambulance services furnished during the period July 1, 2008 through December 31, 2009. Sections 3105(b) and 10311(b) of the Affordable Care Ac t amended section 146(b)(1) of MIPPA to extend this provision for an additional year, through December 31, 2010. In the CY 2011 PFS final rule (75 FR 73385 through 86, 73625 through 26), we revised §414.610(h) to conform the regulations to th is statutory requirement. Section 106(b) of the MMEA amended s ection 146(b)(1) of MI PPA to extend this provision again through December 31, 2011. In the CY 2012 ESRD PPS final rule (76 FR 70284 through 70285, 70315), we revised §414.610(h) to conform the regulations to this statutory requirement. Subsequently, section 306 (b) of the TP TCCA amended section 146(b)(1) of MIPPA to extend this provision through February 29, 2012; and section 3007(b) of the MCTRJCA further731 amended section 146(b)(1) of MIPPA to extend this provision through December 31, 2012. Thus, we proposed to revise §414.610(h) to c onform the regulations to these statutory requirements. We did not receive any comments on this proposal. Therefore, we are finalizing our proposal to revise §414.610(h) to conform to the statutory requireme nts described above. These statutory requirements are self-implementing. A plain reading of th e statute requires only a ministerial application of a ru ral indicator, and does not requir e any substantive exercise of discretion on the part of the Secretary. Accord ingly, for areas that were designated as rural on December 31, 2006, and were subsequently re-desi gnated as urban, we have re-established the “rural” indicator on the ZIP Code file for ai r ambulance services through December 31, 2012. 3. Amendment to section 1834( l) (12) of the Act Section 414 of the Medicare Prescription Dr ug, Improvement and Modernization Act of 2003 (MMA) added paragraph (12) to section 1834(l) of the Act, whic h specified that in the case of ground ambulance services furn ished on or after July 1, 2004, and before January 1, 2010, for which transportation originates in a qualified rural area (as described in the statute), the Secretary shall provide for a percent increase in the base ra te of the fee schedule fo r such transports. The statute requires this percent incr ease to be based on the Secretary’ s estimate of the average cost per trip for such services (not taking into account mileage) in th e lowest quartile of all rural county populations as compared to the average cost per trip for such servic es (not taking into account mileage) in the highest quartile of rural county popu lations. Using the methodology specified in the July 1, 2004 interim final rule (69 FR 40288), we determin ed that this percent increase was equal to 22.6 percent. As require d by the MMA, this payment increase was applied to ground ambulance transports that or iginated in a “qualified rural area”; that is, to transports that originated in a rural area included in those areas comprising the lowest 25th percentile of all rural populations arrayed by populati on density. For this purpose, rural areas included Goldsmith732 areas (a type of rural census tract). Sections 3105(c) and 10311(c) of the Affordable Care Act amended section 1834(l)(12)(A) of the Act to extend this rural bonus for an additional year through December 31, 2010. In the CY 2011 PFS final rule (75 FR 73385 through 73386 and 73625), we revised §414.610(c)(5)(ii) to conf orm the regulations to this statutory requirement. Section 106(c) of the MMEA again amended section 1834(l)(12)(A) of the Act to extend the rural bonus described above for an additi onal year, through December 31, 2011. Therefore, in the CY 2012 ESRD PPS final rule (76 FR 70284 through 70285, 70315), we revised §414.610(c)(5)(ii) to conform the regulations to this statutor y requirement. Subsequently, section 306 (c ) of the TPTCCA amended sec tion 1834(l)(12)(A) of the Act to extend this rural bonus through February 29, 2012; and section 3007( c) of the MCTRJCA further amended section 1834(l)(12)(A) of the Ac t to extend this rural bonus through December 31, 2012. Therefore, we are continuing to apply the 22.6 percent rural bonus described above (in the same manner as in previous years), to ground ambulance services with dates of service on or after January 1, 2012 and before January 1, 2013 wh ere transportation orig inates in a qualified rural area. This rural bonus is sometimes referred to as the “Super Rural B onus” and the qualified rural areas (also known as “super rural” areas) are identified during the claims adjudicative process via the use of a data field in cluded on the CMS-supplied ZIP Code File. In the proposed rule, we proposed to revise §414.610(c)(5)(ii) to c onform the regulations to the statutory requirements set forth at sec tion 306(c) of the TPTCCA and section 3007(c) of the MCTRJCA. We did not receive any comm ents on this proposal. Accordingly, we are finalizing our proposal to revise §414.610(c)(5)(ii) to conform the regulations to these statutory requirements. These statutory requirements are self-implementi ng. Together, these provisions733 require a one-year extension of the rural bonus (which was previously established by the Secretary) through December 31, 2012, and do not requ ire any substantive exercise of discretion on the part of the Secretary. B. Part B Drug Payment: Average Sales Price (ASP) Issues Section 1847A of the Act requires use of the average sales price (ASP) payment methodology for payment for drugs and biologicals described in section 1842( o)(1)(C) of the Act furnished on or after January 1, 2005. The A SP methodology applies to most drugs furnished incident to a physician's service, many drugs fu rnished under the DME benefit, certain oral anticancer drugs, and oral imm unosuppressive drugs. 1. Widely Available Market Price (WAMP) /Average Manufacturer Price (AMP) price substitution If the ASP payment limit for a drug or bi ological exceeds the WAMP or AMP by a threshold percentage, section 1847A(d)(3)(C) of the Act authorizes the Secretary to substitute the lesser of the widely available market price fo r the drug or biological, or 103 percent of the average manufacturer price as determin ed under section 1927(k)(1) of the Act. The applicable threshold percentage is spec ified in section 1847A(d )(3)(B)(i) of the Act as 5 percent for CY 2005. For CY 2006 and subse quent years, section 1847A(d)(3)(B)(ii) of the Act authorizes the Secretary to specify the thre shold percentage for the WAMP or the AMP, or both. In the CY 2006 (70 FR 70222), CY 2007 (71 FR69680), CY 2008 (72 FR 66258), CY 2009 (73 FR 69752), and CY 2010 (74 FR 61904) PFS final rules with comment period, we specified an applicable threshold percentage of 5 percent for both the WAMP and AMP. We based this decision on the fact that data was too limited to support an adjustment to the 5 percent threshold. Beginning in CY 2011, we treated th e WAMP and AMP based adjustments to the applicable threshold percentages separately.734

a. WAMP Threshold and Price Substitution After soliciting and reviewing comments, we finalized proposals to continue the 5 percent WAMP threshold for CY 2011 (75 FR 73469), and CY 2012 (76 FR 73287). For CY 2013, we again had no additional information from OI G studies or other sources that led us to consider an alternative threshold. When maki ng comparisons to the WAMP, we proposed that the applicable threshold percentage remain at 5 percent until such time that a change in the threshold amount is warranted, and we proposed to update §414.904(d)(3)(iv) accordingly. As mentioned above, the threshold has remained at 5 percent since 2005. Our proposal will eliminate the need for annual rule making until a change is warranted. For CY 2013, we did not propose any WAMP ba sed price substitutions. As we noted in the CY 2011 PFS final rule with comment period (75 FR 73470) and reiterated in CY 2012 PFS final rule with comment period (76 FR 73287), we understand that there are complicated operational issues associated w ith the WAMP based substituti on policy, and we continue to proceed cautiously in this area. We rema in committed to providing stakeholders, including providers and manufacturers of dr ugs impacted by potential price substitutions with adequate notice of our intentions, including the opportunity to provide input with regard to the processes for substituting the WAMP for the ASP.
Comment : Several commenters agreed with co ntinuing a cautious approach regarding WAMP-based price substitutions and agreed with maintaining a 5 percent threshold. One commenter agreed with the elimination of annual rulemaking provided that access to drugs is not impacted and that the value can be modified with advance notice to stakeholders. One commenter suggested a higher threshold for th e WAMP substitution due to concern about drug shortages and suggested that CMS study the threshold valu e issue further. Response : The majority of commenters agreed with maintaining a 5 percent WAMP735 threshold. Because, as noted in the proposed ru le and above, available data are limited, and we continue to have no information th at would lead us to believe a different threshold is necessary, we disagree with implementing a hi gher threshold at this time. We also decline to actively study the matter further until such time as future study is warranted, for example, if better information were available for such study. The threshold can be reviewed as warranted and as WAMP-based price substitution policies develop and it can be modified as needed at a later time through rulemaking. Therefore, we are fina lizing §414.904(d)(3)(iv) as proposed. b. AMP Threshold The AMP threshold has remained at 5 percen t since 2005. As with the WAMP threshold, we had no information that led us to believe th at the 5 percent threshold percentage for AMPbased price substitution is inappropriate or shou ld be changed for CY 2013. We proposed that the applicable threshold percentage remain at 5 percent until such time that a change in the threshold amount is warranted, and we proposed to update §414.904(d)(3)(iii) accordingly. Our proposal eliminates the need for annual rulemaking until a change is warranted.
Comment : Two commenters agreed with maintaining the 5 percent AMP price substitution threshold. One commenter suggest ed a higher threshold for the AMP substitution due to concern that a low threshold would trigge r price substitution which would then affect the manufacture of drugs. The commenter suggest ed that CMS study the threshold value issue further. Response : We disagree with increasing the th reshold or studying the threshold value further. Although we acknowledge that the defi nition of AMP is continuing to evolve, this threshold has been in place since 2005 and we ha ve no specific information that persuades us to believe that a change in the AMP threshold is necessary at this time. Also, as with the WAMP threshold discussed in the sect ion above, the AMP threshold can be reviewed as warranted, as736 price substitution policies evolve, and the threshold can be modified as needed at a later time through rulemaking. Therefore, we are finalizing §414.904(d)(3)( iii) as proposed. c. AMP Price Substitution-Additional Conditions ` In the CY 2012 PFS rule, we specified that th e substitution of AMP for ASP will be made only when the ASP exceeds the AMP by 5 percent in 2 consecutive quarters immediately prior to the current pricing quarter, or three of the previo us four quarters immediately prior to the current quarter, and that matching sets of NDCs had to be used in the comparison (76FR 73289 through 73295). The value of the AMP based price substitu tion must also be less than the ASP payment limit that is calculated for the quarter in which the substitution is applied. Also, the price substitution remains in effect for one quarter. We did not apply the price substitution polic y in April 2012 because access concerns led us to reconsider whether it was prudent to pr oceed with price substi tution during a developing situation that was related to a drug shortage that had not met the definition of a public health emergency under section 1847A(e) of th e Act. In light of recent c oncerns about drug shortages, the resulting impact on patient care, beneficiary and provider access, as well as the potential for shortages to suddenly affect drug prices for the provider, under the authority in section 1847A(d)(3)(C) of the Act, we proposed adding §414.904(d)(3)(ii)(C), whic h would prevent the AMP price substitution policy from taking effect if the drug and dosage form represented by the HCPCS code are reported by the FDA on their Current Drug Shortage list (or other FDA reporting tool that identifies shor tages of critical or medically necessary drugs) to be in short supply at the time that ASP payment limits are bei ng finalized for the next quarter. Further, we also clarified that this proposal to add to the safeguards fina lized in CY 2012 only applied to calculations under the AMP-based price substitu tion policy. Our proposal intended to continue the cautious approach described in previous rules and to stri ke a balance between operational737 requirements associated with receiving manufact urers' ASP reports, calculating the payment limits, and posting stable payment limits that will be used to pay claims. We believe that this approach also addresses concerns about access to care, known program issues identified by the OIG, and provides an opportunity for some m odest program savings. However, we did not propose any other changes to the safeguards, timing, or notification that id entifies the codes that will be substituted each quarter. We asked for comments on our approach as well as comments regarding additional specific safeguards for the AMP price substitution policy.
Comment : In general, commenters supported im plementation of a safeguard that would prevent AMP-based substitution of drugs that are known to be in short supply. Several commenters supported our proposal that prevents an AMP-based price substitution from taking effect for drugs that are reporte d to be in short supply. Two co mments supported the use of the FDA’s drug shortage list while another commenter suggested th at the American Society of Health-System Pharmacists (ASHP) shortage li st be used because it might better identify impending shortages. One commenter suggested th at the provision be ex panded to include drugs that are potentially in short supply, but did not provide additional detail. One commenter supported the proposed shortage safeguard if CM S does not further delay the implementation of the AMP substitution policy. Response : We understand the commenters’ reas oning for suggesting that we use the ASHP list, which includes information about sh ortages that may not af fect overall supply-for example the unavailability of a certain vial si ze from one manufacturer. We believe that such detailed information is very useful to c linicians and those who must procure drugs. Nevertheless, we believe that using the FDA lis t, which is compiled from information that is required to be reported by statute and represen ts shortages where overall demand is not being met, will provide us with a consistent standard that reflects national drug supply. Thus, we738

decline to include the ASHP list in our standard. Also, after consultation with the FDA, we are also deleting the phrase “critical or medically necessary” from the proposed regulation text in order to make clear that CMS will not further inte rpret FDA’s drug shortage list. In other words, we are clarifying that a drug’s presence on the list will be sufficient to meet the standard in our final rule, and we will not be taking a position as to whether the drug is “critical or medically necessary” for this purpose. We believe that this modification will also help maintain a consistent standard on which we base our decisi ons. After reviewing the public comments, we are finalizing our proposal and corresponding re gulation text at §414.904(d)(3)(ii)(C) with the modification described in this paragraph.
Comment : Although we did not receive any detaile d suggestions for new safeguards, two commenters also suggested creating safeguards that address AMP data errors and calculations be implemented. Response : We are acknowledging these comments, but since no specific recommendations were made, we will not be addressing them at this time.
Comment : Several commenters stated that im plementation of the AMP-based price substitution should be delayed until the AMP regulat ion is finalized and/or additional experience with calculating AMPs has been gained. Commente rs expressed concerns about the differences in the calculation methodology for ASP and AMP a nd the uncertainty about how “5i” drugs will be affected. Response : We appreciate these comments; however, delaying the AMP-based substitution process is outside the scope of our proposals and we will not further delay implementation of the AMP-based price substitution policy at this time. In the proposed rule (77 FR 44793), we stated that we ar e not proposing any other changes to the safeguards, timing or notification procedures for the AM P-based price substitution. We have explained our reasons for739 proceeding with the AMP-based substitution in the CY 2012 PFS final rule (76 FR 73294-95), where we also discussed the evolving defin ition of AMP and “5i” drugs. In the CY 2012 PFS final rule we stated that we “understand that the updated definition of AMP encompasses sales of injected, infused, instilled, inha led, and implanted drugs that ar e not generally dispensed through a retail community pharmacy, including a wider ra nge of customers and discounted sales to nonpharmacy entities, and commenters' concerns that implementation of the most recent definition could decrease AMP for certain drugs. However, we do not have any specific information from commenters that persuades us to believe that the AMP-based price substitution policy will be applied frequently or to high cost/high volume items, despite the changes to the definition of AMP.” We also continue to believe that the sa feguards finalized in the CY 2012 PFS rule and the additional safeguard finalized in this rule prov ide assurance that the price substitution policy will be applied only when appropriate. In summar y, we appreciate the commenters’ concerns, but our assessment of the overal l situation has not changed. Additional Part B drug-related comments that ar e outside the scope of this rule are listed in section 3 below. 2. Billing for Part B Drugs Administered Incident to a Physician’s Services. This section discusses paym ent policies regarding billing for certain drugs under Medicare Part B. In 2010 and 2011, we issued two change requests (CRs 7109 and 7397) that summarized a number of longstanding drug paym ent policy and billing requirements. We considered these CRs to be merely clarifying, rather than changing, our policy. However, one item in the CRs, which stated that pharmacies ma y not bill for drugs that are used incident to physician’s service, has caused some concer n. Specifically, we understood that some nonphysician suppliers—operating in pa rt on the basis of erroneous guidance from a Medicare contractor--have been submitting claims for drugs that they have shippe d to physicians’ offices740 for use in refilling implanted intrathecal pumps. In light of concern over its potential effect on suppliers, we delayed implementation of the most recently updated CR (CR 7397 Transmittal 2437, April 4, 2012) until January 1, 2013 so that we could undertake rulemaking, evaluate public comments on this issue, and determin e whether CR 7397 should be implemented as planned, revised, or rescinded. Implanted pumps may qualify as Durable Me dical Equipment (DME); however, unlike external pumps used to administer drugs, implanted pumps are typically refilled in a physician’s office. The implanted intrathecal pump is refill ed by injecting the drug in to a pump’s reservoir, which lies below the patient’s skin. The reservoi r is connected to the pump, which delivers the drug to the intrathecal space through a tunneled catheter. The procedure of refilling an intrathecal pain pump is a service that is typica lly performed by the physician because of risk and complexity. To be covered by Medicare Part A or Part B, an item or service must fall within one or more benefit categories within such Parts, and must not be otherwise excluded from coverage. Drugs and biologicals paid under Medicare Part B drugs fall into thr ee basic categories as follows:

● Drugs furnished “incident to” a physician’s services . These are typically injectable drugs that are bought by the physician, administered in the physician’s offi ce, and then billed by the physician to the Medicare Administrative Cont ractor (MAC). By definition, “incident to a physician’s professional service” requires the item or servi ce to be billed by the physician.

● Drugs administered through a covered item of DME . These drugs are supplies necessary for the effective use of DME and are typi cally furnished to the beneficiary by suppliers that are pharmacies (or general DME supplie rs that utilize licensed pharmacists) for administration in a setting other than the physician’ s office. Most DME dr ugs are billed to the741

DME MAC.

● Drugs specified by the statute. These include a variety of drugs, such as oral immunosuppressives and certain vaccines. Depending on the circumstances, drugs used to refill an implanted intrathecal pump can be paid under either the ``incident to'' or th e DME benefit category or Medicare Part D. The CMS Benefit Policy Manual (100-02 Chapter 15 S ection 50.3) states that drugs paid under the “incident to” provision are of a fo rm that is not usually self-a dministered; are furnished by a physician; and are administered by the physicia n, or by auxiliary personnel employed by the physician and under the physician’s personal superv ision. Section 60.1 A requires that “to be covered, supplies, including drugs and biologicals, must represent an expense to the physician or legal entity billing.” In what we believe is a typical situation, when physicia ns’ services are used to refill an intrathecal pump, the “incident to” requirements can be met because, consistent with our guidance and longstanding policy, the physician or other professional employed by his or her office performs a procedure to in ject the drug into the implante d pump’s reservoir (that is, the drug is not self-administered), and the drug repres ents a cost to the physician because he or she has purchased it. Conversely, we believe that in the typical situation, paym ent to a pharmacy or other nonphysician supplier under the DME benefit for a drug dispensed for use in the physician’s office is both inappropriate and inconsistent with existing guidance. For example, DME prosthetics, orthotics, and supplies (POS) policy does not permit payment for prosthetics dispensed prior to the procedure that makes necessary the use of the device. Moreover, in the case of prescription drugs used in conjunction with DME, our guida nce is clear that the entity that dispenses the drug needs to furnish it direct ly to the patient for whom a prescription is written. An arrangement whereby a pharmacy (o r supplier) ships a drug to a physician’s office742 for administration to a patient does not constitu te furnishing the drug directly to the patient. We note that payment to pharmacies (or supplie rs) for drugs used to refill an implanted pump can be made under the DME benefit categorywhere the drug is directly dispensed to a patient and the implanted pump is refilled with out a physician’s service. However, it is our understanding that implanted pumps are rarely refilled without utiliz ing the service of a physician. In the proposed rule, we stated our concer n about stakeholders’ reports that, due to incorrect guidance from a contractor, Medicare pa yment policy on this issu e has been applied in an inconsistent manner. We stated that we cons ider the contractor’s gui dance to be erroneous. This inconsistency has permitted supplier claims for drugs dispensed by pharmacies to physicians’ offices to be paid in some jurisdictio ns and denied in others . We understand that the inconsistent application of our payment policy has influenced the business and professional practices of pharmacies/DME supplie rs that prepare drugs for implan ted pumps. We stated that we do not believe that payment for drugs used to refill implanted DME should continue to be made because such action is not supported under l ong standing policy and, as discussed above, is not appropriate. We proposed to clarify that we consider drugs used by a physician to refill an implanted item of DME to be within the “incident to” be nefit category and not the DME benefit category. Therefore, for the drug to be paid under Part B, the physician must buy and bill for the drug, and a non-physician supplier that has shipped the drug to the physician’s office may not do so. We asked for comments on this proposal and its pote ntial impact on beneficiaries and providers.
Comment: One commenter questioned CMS’s assumptions in proposing the policy clarification and contends that contrary to these assumptions, pharmacy billing for drugs used by a physician to refill an implanted pump under the DME benefit is appropriate. Specifically, the743 commenter questioned CMS’s assertion that th e physician refilling the implanted pump is “administering” the drug, contending instead th at the pump administers the drug and that the physician does not exclusively administer th e drug. Second, the commenter disagrees with CMS’s statement that pharmacies’ shipping drugs to physician offices are not furnishing drugs directly to the patient and contends that thes e medications are dispensed specifically to the patient at the physician’s office. Response : We disagree with these comments. With respect to whether the physician is administering these drugs, we understand that the implanted pump serves to release the drug into a specific region of the patient’s body over a pr olonged time period. However, the process of refilling the implanted pump, de termining the correct pump setti ngs, and making adjustments to those settings as needed is us ually carried out by a licensed he althcare provider, typically a physician. In our view, the pump’s role is analogous to a drug with a sustained release rate (for example, leuprolide depot injection) that is injected or implanted into the body, which is similarly furnished incident to a physician’s profe ssional service. Further, the relevant inquiry is not whether a drug is “exclusive ly” administered by a physician, but rather whether the drug is “not usually self-administered by the patient ” and furnished incident to a physician’s professional service. Thus, even if the physic ian did not “exclusively” administer the drug because of the action of the pump, it does not follow that a more appropriate benefit category for such a drug would be the DME benefit category. Under the incident to provision, we associ ate payment for the drug with the physician’s professional service, and the drug is a key compon ent of the billable procedure that is paid incident to a physician’s professi onal service. As we have desc ribed earlier, when an implanted article of DME is refilled in the physician’s o ffice, the drug required for the service must meet the three conditions of the incident to benef it described in the Claims Processing manual,744 Chapter 15, Section 50.1, where the dr ug or biological must be of a fo rm that is not usually selfadministered; must be furnished by the physician; and must be administered by the physician, or by auxiliary personnel employed by the physic ian and under the physician’s personal supervision. Based on discussion with stakeholders , it is our understanding that most refills of implanted DME that are done in the physician’s o ffice meet these conditions. In contrast, under the DME benefit category, a pharmacist dispen ses the drug as a supply necessary for the effective use an item of DME (including, an im planted pump) and a physician’s service is not utilized for the drug administration process. In addition, we disagree with the commenter’s assertion that by sending a drug to the physician’s office for a specific patient, it is furnis hing the drug directly to the patient, because such delivery would not be made without the physician’s being at th e delivery location to administer the drug in his or her office. It is notable that the commenter neglected to describe what happens to the drug that it asserts is deli vered “directly” to the pa tient at the physician’s office if the patient cannot receive a pump refill at the time of such delivery. Presumably the physician’s office or the pharmacy, rather than the patient, would be resp onsible for the storage of the drug until it could be safely used or for di sposal or return of an unused and unopened dose, which would indicate that at no tim e did the patient take “delivery” of the drug. In any event, in light of the physician’s integral role in receipt and administra tion of the drug, the DME benefit category does not appropriately apply to this situation. Moreover, th e incident to benefit category does not permit pharmacy billing for th e incident to drug. Pharmacy/DME supplier dispensed drugs that are to be us ed incident to a physician’s serv ice do not meet the “incident to” conditions because the pharmacist does not refill the implanted pump. However, we believe that it is important to preserve the potential for paying a pharmacy for a drug that is used to refill implanted pumps in certain limited instances where a physician’s745 service is not used. Although pa tients and caregivers do not typical ly refill implanted pumps, it is our understanding that in rare situations pers ons other than a physician (as defined by section 1861(r) of the Act) could refill the pump, for example, when a patient cannot be transported to a physician’s office, but a suitably trai ned individual is available at th e home. We believe that this situation is very uncommon, but we also believe that in certain s ituations, for example in remote locations, it may facilitate the administration of refills of implanted durable medical equipment in situations where a beneficiary cannot be trans ported to the office, but a qualified individual is available to fill the pump and the drug is dispense d directly to the patient at home. In these situations, the drug is not being administered by the physician, and therefore the drug cannot be billed incident to a physician’s se rvice. As there is no service incident to a physician’s service and the drug is being dispensed directly to the beneficiary in the home for use in an implanted item of DME, the pharmacy may bill and be paid for the drug.
Comment: Several commenters note that the proposed rule describes the error as being associated with only one contractor , but that several others since ha ve allowed for and paid direct pharmacy claims for drugs used by physicians to refill implanted pumps. A comment from a group of pharmacies that compounds drugs for us e in implanted pumps states that four contractors across 13 States have paid pharmacies directly in these instances. Commenters located in other states supported adoption of th e erroneous approach in their states. One commenter stated that the majority of pharmacies in the country are in compliance with the buy and bill approach. Response: Although the proposed rule (77 FR 44793) stated that erroneous guidance came from “one contractor,” in the same para graph we acknowledged that payments were made in some jurisdictions and denied in others. Th us, the proposed rule indi cated that we understood that several contractors had paid pharmacies under the erro neous approach. Although we746 understand that the use of the erroneous approach has expanded, this does not persuade us to make a national policy decision that incorporates a payment policy that is based on contractor error simply because it has become utilized in some areas. Moreover, the commenters recommending adoption of the erroneous approach notably did not assert that the physician “buy and bill” method has been problematic in their states, and these comments, in our view, support our belief that the erroneous approach is not a widespread problem.
Comment: Several comments mentioned that regulation text at §424.57 permits pharmacy suppliers to be paid for drugs us ed with DME. One comment stated that administrative law judge (ALJ) decisions favorable to pharmacies that furnished drugs under the erroneous guidance were based on this regulation text. Response: We agree that pharmacy suppliers can be paid for drugs used as supplies for DME. This provision applies most frequently to situations like drugs us ed with nebulizers or external pumps where multiple doses of drugs are dispensed and delivered to a patient for use over a given time period. However, instances in which direct billing by a pharmacy or DME supplier for these drugs, which are self-administe red via an item of DM E, are distinguishable from the situation here, where a li censed healthcare provider’s prof essional service is required to ensure that the drug may be used with the item of DME. Physicians who refill these pumps in the office are generally not acting as DME suppliers. With respect to the assertion about ALJ decisions , we are persuaded only that they are evidence that our payment policy has been applied inc onsistently, and do not consider them to be indicators of what the correct payment policy is or should be.
Comment : Several commenters believe that our pr oposed clarification is in conflict with state and federal laws regarding the dispensing an d/or distribution of controlled substances and Food and Drug Administration (FDA) guidance. Specifically, commenters asserted that our747 proposed clarification is incons istent with Drug Enforcement Ad ministration (DEA) rules that apply to dispensing of controlled substances and that operating under a distribution model would require them to register with the DEA as manufacturers, which would raise concerns under applicable state law. Further, two commenter s suggested that our Pa rt B drug billing policy instructs pharmacies to sell compounded products to physicians for resale to the patient in contravention of FDA guidance regarding pha rmacy compounding compliance. Commenters noted that FDA’s policy guidance delineates “act s of drug manufacturing” that would apply to pharmacies complying with our proposed clarifi cation because it would require them to sell compounded products to third parties who resell to individual patients, and it would cause them to fail to operate in conformance with applicable state law regulating the practice of pharmacy. Commenters, including one state board of pharm acy, also contended that with respect to compounded controlled substances used to refill imp lanted pumps, the proc edures that would be required under our proposed clarification would not be allowable under state law. Response : We understand that the laws and regu lations pertaining to how compounded doses of drugs used to refill implanted DME are obtained by the office are complex and may include requirements from a va riety of sources, including the DE A, the FDA, and the states. This rule does not seek to inte rpret applicable laws, regulations, or guidance from these and other relevant sources, nor does it seek to disti nguish among the varying uses of terms by these agencies, including terms such as compound, manufacture, distribute, or resell, which may have context-dependent, specific definitions that are impor tant, but also can conf use issues related to Medicare part B payment policy. This rule pertai ns solely to Part B payment policy, and we take no position on any issue other than which party mu st bill for a drug used by a physician to refill an implanted item of DME. Thus, this rule doe s not address whether a pharmacy, for example, should be dispensing or distribut ing a drug used to refill impl anted DME. Indeed, we do not748 have authority to interpret or apply F DA, DEA or state laws or regulations. That being said, we wish to respond to these co mments as fully as we can, in the interest of transparency. We do not agree with the suggestions that the buy and bill approach for obtaining drugs used by physician for refilling implanted pumps in the office is strictly prohibited, because if it were, our payment policy for drugs used to refill implanted DME, with which the majority of physician offices and pha rmacies already comply, would have raised concerns from stakeholders across the country long before we issued the two CRs last year. Further, we disagree that our policy is in conflict with laws pertaining to controlled substances. First, we note that our policy is not specific to controlled substances, and the comments do not persuade us to adopt a differe nt policy for controlled substances used by a physician to refill an implante d item of DME from the Part B payment policy for all other controlled substances administered incident to a physician’s prof essional service. It has long been our policy that drugs furnished incident to a physician’s professional service must be purchased and billed by the physician, and in general physicians buy and bill for controlled substances furnished under the incident to benefit without being in violation of DEA requirements. We have consulted with DEA about the issue of controlled substances used in implanted DME, and they have confirmed our unde rstanding of DEA rules as discussed below. It is our understanding from discussions with th e DEA that it is a criminal violation of the law when a DEA-registered pharmacy dispen ses a controlled substa nce and knowingly or intentionally delivers that substance to any pers on other than the patien t or a member of the patient’s household. We understand that the DE A provides for registration of entities, including pharmacies, as DEA registered manufacturer/dis tributors that may di stribute controlled substances to providers under conditions outlined by the DEA. We understand that the DEA’s “5 percent rule” may apply to pharmacies that are not manufacturers and that wish to provide749 these drugs to the office; however, we also unders tand that the 5 percent rule may not apply to situations where a drug must be compounded from bulk chemicals. In any event, we have confirmed with the DEA that pharmacies can regist er with the DEA as a distributor/manufacturer and under such a registration, can sell these drugs to a physician’s office. The office would order the drugs using DEA Form 222 (http: //www.deadiversion.usdoj.gov/faq/dea222.htm ) which facilitates purchasing and tr acking of controlled substan ces between registrants and accountability at the pharmacy and the office. We also note that the DEA provides its own specific definition of a manufacturer. Additional information is at http://www.deadiversion.usdoj.gov/drugr eg/reg_apps/225/225_instruct.htm

. Thus, we believe pharmacies can be in comp liance with the DEA regul ations in providing controlled substances to physicians who can then bill Medicare under the “incident to” benefit category. Indeed, we are concerned that curr ent practices described by some commenters are inconsistent with DEA regulati ons. Some commenters describe d dispensing activities that appear to deliver the drugs to the office on beha lf of the patient (that is, “dispensing for a patient”) in a manner that may not be consiste nt with DEA regulations, which require that controlled substances be dispense d directly to the patient, and not to an agent, person, or other entity that is acting on the patient’s behalf. We also have concerns about the ad hoc record keeping methods (like delivery logs) for controlle d substance prescription delivery that were described in some comments. Such an approach does not appear to comply with practices that are required by the DEA for transfers or sales of drug between registrants. This process involves the use of DEA Form 222 and related record ke eping that is describe d in DEA regulation. We also note that not all of the drugs used in implanted pumps are drugs are controlled substances. Some of the anal gesics (for example, ziconitid e and clonidine) often used in implanted pumps are not opiates, an d are not always used in conj unction with opiates. Agents750 used to treat spasiticy (baclofen) are also not opiates. These medica tions are not controlled substances, and the DEA provision s discussed above do not apply. With respect to comments about conflic ts with FDA guidance, we cannot make statements about when the FDA may require that compounding pharmacies be considered manufacturers; as noted above, th is is outside of CMS’s scope of authority and expertise. Nevertheless, we disagree that our proposed cl arification would, in itself, require that compounding pharmacies be considered manufactu rers. The FDA Compliance Policy Guidance on pharmacy compounding ( http://www.fda.gov/ICECI/ComplianceManuals /CompliancePolicyGuidanceManual/ucm07439 8.htm ) states that the guidance “doe s not create or confer any ri ghts for or on any person and does not operate to bind FDA or the public.” The policy states that in determining whether to take enforcement action the FDA “will consider whether the pharmacy engages in ... [certain] acts.” Points 7 and 9 in the list of acts referred to by one commenter includ e the act of reselling a drug and State law. The use of an individuali zed dose of a drug that has been prepared by a pharmacy for use upon a physician’s order for a sp ecific patient and is administered by a physician in an office incident to a procedur e in the office is not reselling a drug. Finally, many of the comments pert aining to State law involve d dispensing activities. However, our proposal did not ad dress, and we do not take a pos ition now, with respect to whether a pharmacy should dispense or distri bute a drug used by a physician to refill an implanted item of DME in the physician office. We understand that State laws pertaining to dispensing of prescriptions may be problematic because they are not uniform across States and the interpretation of all require ments may vary. However, the comments did not foreclose the possibility that an appropriately registered and licensed pharmacy could sell the drug to the physician’s office, for example when the pharmacy does not act as a dispen ser of a prescription,751 but acts as a distributor of a drug. In response to the state board of pharmacy’s comment, we note that the comment appears to indicate that pr escriptions in the state must be dispensed in accordance with DEA requirements. As stated above , we believe it is possible to comply with DEA requirements under the buy-and-bill method. Our approach also minimizes program integr ity concerns and avoids a situation where billing for a procedure and an ite m necessary for the procedure is done by two different entities that may submit claims with two dates of servi ce. Such corresponding services are difficult to match during claims processing and the presump tion that a drug that ha s been dispensed in advance of the pump refill will always be admini stered to the benefici ary may not always be correct. In other words, our approach minimi zes the opportunity for fraud and abuse caused by splitting up payment for related components of a se rvice between providers that bill separately. Further, as noted above and as borne out by our experience admini stering and overseeing the Medicare program, the buy and bill approach does not appear to be problematic in a majority of the country. Therefore, in considering these comments, we c ontinue to believe that it is appropriate for Medicare payment policy to be unif orm, in spite of the fact that suppliers in certain states may need to adjust their regulatory standing with the state in order to comply with our payment rules. As stated above, inconsiste nt application of the policy has influenced the business and professional practices of pharmaci es/DME suppliers that prepare drugs for implanted pumps. Specifically, pha rmacies that have been allowed to bill directly to Medicare have marketed this approach to physicians at the expense of pharmacie s that have not been allowed to direct bill. Inconsistent applica tion of the policy has given a distinct economic advantage to some pharmacies relative to others th at we do not believe is equitable. A uniform policy is more fair and predictable for beneficiar ies and health care provide rs, and is easier to administer and oversee and, as stated above, is consistent with longsta nding Medicare law and752 regulations and minimizes the pote ntial for fraud and abuse. Nevertheless, if a physician doe s not have a cost for these drugs, the physician does not meet the requirements to bill for these drugs under Medicare Part B as an “incident to” drug. As explained above, these drugs are also not bill able under Part B as DME supplies because the drugs are not being furnished directly to the be neficiary. However, thes e drugs may be payable to the pharmacy under Part D if the ingredients that are bein g compounded independently meet the definition of a Part D drugs—generally a commercial FDA approved drug product. We have considered the implications of th e proposed clarification on patient care and Medicare providers (including physicians and ph armacies). Review of the comments also indicated that the issue is not national, but does affect the sout h central region of the contiguous United States more than other regions and theref ore we believe that providers in most states follow the proposed approach and most states’ laws do not create insurmountable barriers for physician offices that administer refills of im planted DME equipment to obtain drugs. We do not believe that major revisions to policy should be based on err oneous guidance that originated from a single contractor, nor do we believe that we should permit an inconsistent practice to continue indefinitely, because the delay is affecting both thos e who are in compliance with national payment policy, as well as those who are not.
Comment : We received several comments on the pot ential impact of our proposal. Most commenters expressed concern abou t the financial impact of our proposal on physician practices, especially small practices. Three major concerns stated were the financial impact of having to buy potentially expensive drugs, the labor invol ved in submitting claims, and the time that elapses between the administration of the drug and when the drug claim is paid. Physicians and office staff that currently are obtaining the dr ugs through pharmacies that also bill for the drug were concerned that obtaining these drugs us ing a buy and bill approach is not financially753 sustainable and would lead practices to disconti nue providing pump refills. Several commenters stated that practices relied on the pharmacy-d ispensed and pharmacy-billed approach. Two groups of pharmacies asserted that this clarifica tion will affect their abi lity to be paid under Medicare Part B for providing intrathecal pain medications, especially medications that contain Schedule II controlled substances. Comments about the potential impact to be neficiaries included suggestions that some practices would charge benefici aries up front, that some physic ians might convert medication regimens to the oral route -- which may not be as well tolerated or as e fficacious, or that access could be impaired. Response : We acknowledge that our policy clarif ication will affect physicians, suppliers and beneficiaries in cases wh ere the pharmacies have been billing for drugs used by the physician to refill implanted DME. Based on the comments on our proposal, we do not believe that these pharmacies represent all or the majo rity of pharmacies or the providers who obtain pharmacy prepared drugs in their offices. As we have discussed elsewhere, we believe that the drug distribution pathway is available for phys ician offices to purchase these drugs from appropriately licensed and registered pharmacies in cases where the drugs cannot be dispensed.

We do not believe we should incorporate a change or permit continued inconsistent application of our policies based on erroneous guid ance. As we have stated above and in the proposed rule, the erroneous guidance significantly conflicts with longsta nding national policies for drugs provided incident to physicians’ services and items furnished under the DME benefit. Based on the comments, we understand that ma ny pharmacies that prepare drugs used to refill implanted pumps and the providers with whom they have a relationship are unaffected by the policy clarification in the CRs and this ru le. Based on publicly available information, we754 understand that some pharmacies that prepare dose s of intrathecally administered medications for Medicare beneficiaries (including some of the commenters who opposed our clarification) are already registered with the DEA as drug distri butors. We understand that these entities can receive orders for controlled s ubstances via the DEA 222 form a nd can sell (that is, distribute) the individually prepared doses to the physician provider, who in turn administers the drug and bills Medicare part B. As discussed above, our approach also minimizes program risk that arises from billing for a procedure and an item necessary for the pro cedure by two different entities that may submit claims with two dates of service. We believe fraud and abuse risk is minimized by requiring the same entity to bill for the drug and its administration. We are concerned by comments that suggested that some practices may charge Medicare patients up front. We would like to remind phys icians that Medicare providers who accept assignment may not charge up front, and note th at section 1842(o)(3)(A ) of the Act requires these drugs to be paid on an assignment-rela ted basis. Also, the routine use of advance beneficiary notices (ABNs) is not allowed ( See the Medicare Claims Processing Manual, chapter 30, Section 40.3.6 at http://www.cms.gov/Regulations-andGuidance/Guidance/Manua ls/downloads/clm104c30.pdf ).
Comment: Several comments stated that CMS’ proposed approach will cause physicians to discontinue the use of intrat hecal pain managements and to switch to oral analgesics, thereby increasing the risk of diversion. Response : We do not believe this policy clarif ication will increase the risk of drug diversion. We acknowledge that di version can occur, perhaps particularly in instances where an individual receives high doses of analgesics, but we do not belie ve that either the oral or injectable approach is entirely risk free. Th e risk of drug diversion and pump tampering also755 exists with implanted pumps and ha s been reported in literature.
Comment : One commenter stated that CMS policy, as reflected in the Benefit Policy Manual, allows a physician to be paid for admini stering a drug that has not been bought by the office. The commenter suggests that CMS policy would permit the physician to bill for administration of a drug used to refill an implan ted pump even if the physician did not incur the cost for it, and for this reason, the drug should be payable under the DME benefit. Response : We disagree with the commenter’s c onclusion. The Benefit Policy Manual the commenter cites (Chapter 15, sec tion 60.1A) uses the example of dr ug administration in the case where the patient has purchased the drug, stating that the drug administration service would be covered, even though drug would not be. We do not believe it follows from this example that drugs used by a physician to refill an implan ted item of DME should be included in the DME benefit category. In fact, we believe the manual provision cited by the commenter actually supports our position – namely, that the drug in question is not covered under Part B if the physician administering it incident to a professional se rvice has not incurred the cost for it.
Comment : Two commenters expressed support fo r our clarification. One commenter described the policy as longstandi ng and believed that most pharmacies are in compliance with this standard. Another commenter stressed th e importance of consistent payment policy and expressed concern that pharmacies that billed under the incident to provision not be subject to audits or recoupment if they were acting on good faith based on contractor guidance. Response : We agree with the comments that su pported our policy clarification. We thank those who commented on a dditional issues for their thoughts. As we have stated previously, we believe Medicare ’s policy on this issue has been longstanding. However, we acknowledge that there ar e pharmacies that were relying on in correct contractor guidance to bill Medicare directly for these drugs . For these reasons, we do not pl an to take enforcement action756 for incorrect billing of drugs used to refill an implanted item of DME furnished in a physician’s office by pharmacies prior to January 1, 2013 if th at incorrect billing st emmed directly from guidance from a Medicare contractor.
Comment : Some commenters expressed concerns th at the clarification is a change in policy. Another commenter believes that the f act that we delayed the CR amounts to a tacit approval of pharmacy billing for drugs used by physicians to refill implanted pumps. Response : We disagree that this is a change in our policy. As we stated in the proposed rule, we consider the contractor guidance on pharmacy billing of drugs used to refill implanted items of DME to be erroneous. We believe it was erroneous for other contractors to adopt similar processes. Nevertheless, in light of stakeholder concer ns, we delayed the implementation of two CRs and undertook th is rulemaking process to ensure that even if our clarification were considered a change in policy, potentially affect ed parties would have notice and a meaningful opportunity to comment. Thus, our decision to delay the CRs’ implementation was not because we approved of, or even condoned, pharmacy billing for these drugs. Rather, we delayed the CRs’ implementation to permit further consideration of this issue and ultimately, this rulemaking process. As we undertake rulemaking with respec t to payment for Part B drugs generally on an annual basis, we proposed this clarificati on at the earliest avai lable opportunity. Moreover, in addition to th e other indications discussed el sewhere, our claims processing structure indicates that these drugs generall y are billed by physician s incident to their professional service. CMS Change Request 222 7 dated July 22, 2002 required that “bills for implanted DME ... accessories and supplies for th e implanted DME must be billed to local carriers.” This instruction removed claims processing for drugs used to refill implanted DME from the DME MAC environment (where pharmacy-based part B claims are typically submitted) and assigned the responsibility to the local carrier, now referred to as a Medicare Administrative757 Contractor (MAC) (where physicians’ claims are typically submitted). This instruction, now 10 years old, indicates that we have long intended that payment for drugs used to refill implanted pumps in the physician’s office be received primar ily by the physician’s office rather than nonphysician providers/DME suppliers. Finally, we wish to clarify one other point. In the proposed rule, we stated that in the case of drugs used to refill an implantable item of DME, “the physician must buy and bill for the drug, and a nonphysician supplier that has shipped the drug to the physician’s office may not do so (except as may be permitted pursuant to a vali d reassignment).” Our reference to a “valid reassignment” was intended to refer only to the f act that in certain limited cases, as specified in section 1842(b)(6) of the Act and its implementi ng regulations, a physician may reassign a claim for Medicare payment. To the extent that our reference to a “valid reassignment” in the proposed rule implied that a physician could permi ssibly reassign a claim for a drug used to refill an implanted item of DME to a pharm acy supplier, it was in error. Conclusion : After considering the comments and the potential impact on beneficiaries, health care providers and Medicare payment po licy for DME and drugs used incident to a physician’s service, we are fi nalizing the provision as pr oposed. We are finalizing the clarification that we consider drugs used by a phy sician to refill any implanted item of DME to be within the “incident to” benefit category and not the DME benefit category, and we are adding regulation text at §410.26 to codify our policy. Therefore, to bill under the “incident to” benefit, the physician must buy and bill for th e drug, and a non-physician supplier that has shipped the drug to the physician’ s office may not do so. In cert ain circumstances, for example if the physician does not incur an expense for the drug, Medicare Part D may be able provide payment to the pharmacy for these drugs. We be lieve that our position is straightforward, is consistent with how national part B drug paym ent policy is applied in the physician office758 setting, and is already adhered to across most of the country. Cons istent with this final rule, CR 7397 will go into effect on January 1, 2013. We maintain that CR 7397 (and its predece ssor CR 7109) does not change longstanding Part B drug payment policy for drugs paid under s ection 1847A of the Act, in particular, that a drug provided incident to a physic ian’s service must represent an expense to the physician. Neither laws nor regulations that authorize such payment have b een changed since the erroneous guidance was brought to CMS’ attention. Corre sponding instructions in the Benefit Policy Manual (Publication 100-02, Chapter 15, sections 50.3 and 60.1) also have not changed. The instructions in the CRs that clar ified that payment for drugs furnis hed incident to the filling or refilling of an implanted pump or reservoir ar e determined under section 1847A of the Act and pharmacies (including DME suppliers that utiliz e pharmacists to dispense medications) may not bill Medicare Part B for drugs provided to a physician for administration to a Medicare beneficiary also have not cha nged. We believe that these facts confirm that our policy clarification is consistent with longstanding statute, regulation, and manual instructions that pertain to Medicare national policy and that our policy remains the appropriate one. 3. Out of Scope Comments. In addition to comments requesting us to de lay AMP-based price substitution that were discussed at the end of Section 1.c., we recei ved comments pertaining to the creation of unique HCPCS codes for new branded drugs and biologi cals, the payment amount for part B drugs, supply and dispensing fees, concerns about the timeliness of claims processing and claims denials, payment incentives that would decrease th e impact of drug shortages, the duration of the quarterly AMP-based price substitution, notice of price substitution for manufacturers, and safeguards for WAMP-based price substitution. In the proposed rule, we stated that we are not proposing any other changes to the759 safeguards, timing or notification procedures for the AMP-based price substitution. Comments on these and other issues listed in the paragraph above are outside the sc ope of this rule, and therefore, are not addressed in th is final rule with comment period. C. Durable Medical Equipment (DME) Face-to-F ace Encounters and Written Orders Prior to Delivery 1. Background Sections 1832, 1834, and 1861 of the Act establis h that the provision of durable medical equipment, prosthetic, orthotics, and supplies (DMEPOS) is a covered benefit under Part B of the Medicare program. Section 1834(a)(11)(B)(i) of th e Act, as redesignated by the Affordable Care Act, authorizes us to require, for Specified Cove red Items, that payment may only be made under section 1834(a) of the Act if a physician has communicated to the supplier a written order for the item, before delivery of the item. Section 1834(h )(3) of the Act states th at section 1834(a)(11) applies to prosthetic devices, orthotics, and pros thetics in the same manner as it applies to items of durable medical equipment (DME). In a December 7, 1992 final rule (57 FR 57675), we implemented this provision in §410.38(g), for DM E items and §410.36(b) for prosthetic devices, orthotics, and prosthetics. Toge ther these sections state that as a requirement for payment, CMS, a carrier, or, more recently, a Medicare Administ rative Contractor (MAC) may determine that an item of durable medical equipment, and prosthet ic and orthotic supplie s (DMEPOS) requires a written physician order before delivery. In addi tion to the regulations listed at §410.38(g) and §410.36(b), we have stated in Chapter 5, Secti on 5.2.3.1 of the Program Integrity Manual, that the following items require a written order prior to delivery: (1) pressure reducing pads, mattress overlays, mattresses, and beds; (2) seatlift m echanisms; (3) transcutaneous electrical nerve stimulation (TENS) units; (4) power operate d vehicles (POVs) and power wheelchairs.760 Section 6407(b) of the Affordable Care Act amended section 1834(a)(1 1)(B) of the Act. The Affordable Care Act added language to the Ac t that requires for certain items of DME, a physician documenting that a physician, a physician assistant (PA), a nurse practitioner (NP), or a clinical nurse specialist (CNS ) has had a face-to-face encounter with the beneficiary pursuant to the written order. Under sec tion 1834(h)(3) of the Act, the ite ms that require a written order verifying a face to face encounter may also include prosthetic devices, orthotics, and prosthetics. The encounter must occur during the 6 months pr ior to the written order for each item or during such other reasonable timeframe as specified by the Secretary. 2. Provisions of the Proposed Regulations and Summary of the Public Comments We have made a series of modifications to the rule based on response to comments. As a result of comments, we are implementing several changes and clarifications to limit burden and still protect the Medicare Trust Funds. We have clarified that this re quirement will begin only for new orders written after the effective date . We believe it is important to apply this requirement prospectively and not retroactivel y. To allow sufficient time for implementation, the effective date of this provi sion is July 1, 2013. Therefore, covered items ordered on or after July 1, 2013 will require a face-to -face encounter. Additionally, we have modified the timeline to require that a face-to-face encounter occur within 6 months before the written order. We have also added an additional criteri on to remove items from the list of covered items. This is discussed in further detail below.
Comment : Several commenters questioned if thes e requirements adequately address the central drivers of fraud in the home health care and DME supply industries. If the goal is to eliminate the situation where a physician signs a DME order for a patient they know little about, having a physician sign off on a PA not e does little to meet the goal. Response : We believe that increasing physician involvement will help limit waste, fraud,761 and abuse while encouraging beneficiaries to ma intain access to the necessary services. We believe physician involvement will not only assist in reducing waste, fraud and abuse but it will also help to ensure that benefi ciaries receive high quality DME to meet their specific needs. Further, because a face-to-face encounter documen ted by a physician is a statutory requirement, CMS is required to implement this provision.
Comment : One commenter noted that the proposed rule does not address the role of the Certificate of Medical Necessity (CMN ) under the DME face-to-face policy. Response : The commenter is correct that the fa ce-to-face requirement addressed in this regulation does not change exis ting policy related to CMNs. Th e face-to-face requirement does not change the CMN process for those items th at require a face-to-face. The face-to-face encounter can be completed at the same time as the CMN.
Comment : A commenter noted that, the rule requiring face-to-face encounters and written orders prior to DME delivery uses the terms “physician” and “practitioner” inconsistently. Specifically, physicia n is the only term used to desc ribe those authorized to order DME, which seems to imply that physicians are the only practitioners who may order DME. The proposal then goes on to state that PAs, NPs a nd physicians may perform the face-to-face visit for DME. Response: We would like to clar ify that under sec tion 1834(a)(11)(B)(ii) of the Act, physicians, physician assistants, clin ical nurse specialists and nurse practitioners are authorized to conduct the face-to-face encounter . We collectively refer to physicians, NPs, PAs and CNSs as “practitioners.” Howeve r, according to the statute, the physician must document that the faceto-face encounter occurred when performed by th e PA, NP, or CNS. Items of DME can be ordered as outlined in the scope of practice for th e respective practitioners subject to applicable Medicare rules. However, the face-to-face must be performed by the physician, PA, NP or CNS762 and documented by a physician.
Comment: Several commenters requested that CMS clarify whether the hospitalist ordering the DME for the inpatient and who has th e face-to-face encounter w ith the patient prior to discharge must meet the f ace-to-face encounter requirement. Response : Medicare beneficiaries discharged from a hospital do not need to receive a separate face-to-face encounter, as long as the physician or treating practitioner who performed the face-to-face encounter in the hos pital issues the DME order within 6 months after the date of discharge.
Comment : Several commenters requested clarification that this requirement is for new DME orders and not for existing orders. Commente rs were concerned that if the proposed faceto-face encounter requirements were to apply retro actively to orders alrea dy written (that is, each new shipment after the effective date of the final rule would need to comply with the requirements), suppliers may be required to obtain new physician or ders for all of the Medicare beneficiaries whom they serve. Response : We clarify that this requirement is for new DME orders only. That is, items that have been ordered on or after th e effective date of this final rule.
Comment : Several commenters requested that the effective date of the rule be delayed until July 1, 2013, or such later date as found re asonable to provide adequate education to patients and suppliers about the new require ments. Commenters recommended that CMS provide extensive education on the documentation requirements, and alert beneficiaries to the new co-payment possibility associated with the face-to-face encounter while emphasizing the improved quality of care aspect of this rule. Response : We agree, and are, therefore, dela ying the implementation date until July 1, 2013. We believe that provides sufficient time to prepare for implementation.763

Comment : A few commenters stated that to ensure the integrity of the competitive bidding program’s single payment amounts, CMS must e ither (1) ensure that the final rule adopts provisions that are wholly cons istent with the current documen tation requirements dictated by the LCDs; (2) exempt items subject to competitive bidding from the proposed documentation requirements during the bid program; or (3) permit s uppliers to resubmit bids for these items that take these additional costs into account. Response : This requirement is a condition of payment that applies uniformly to these items regardless of whether they are paid fo r under the fee schedule or the competitive bidding program. There are no exceptions for items that are furnished in a competitive bidding area. Moreover, as noted in the impact analysis, we believe that this requirement will not result in significant costs for suppliers.
a. DME Face-to-Face Encounters (1) General Requirements We had proposed to revise §410.38(g) to requir e, as a condition of payment for certain covered items of DME, that a physician must have documented and communicated to the DME supplier that the physician or a PA, an NP, or a CNS has had a face-to-face encounter with the beneficiary no more than 90 days before the order is written or within 30 days after the order is written. As described in the CY 2013 PFS proposed rule (77 FR 44794), we outlined the rationale for the 90 days before or 30 days after the order was written. During the face-to-face encounter, the physician, a PA, NP, or CNS must have evaluated the beneficiary, conducted a needs assessment for th e beneficiary or treated the beneficiary for the medical condition that supports the need fo r each covered item of DM E. As a matter of practice, this information would be part of th e beneficiary’s medical record and include the identity of the practitioner who provided the face-to-face assessmen t. We believe that requiring764

a face-to-face encounter to document the medical condition that supports the need for the covered item of DME reduces the ri sk of fraud, waste, and abuse since these visits help ensure that a beneficiary’s condition warra nts the covered item of DME. Section 1834(a)(11)(B)(ii) of the Act, as amended by section 6407(b) of the Affordable Care Act, states that a physician must documen t that the physician, a PA , NP, or CNS has had a face-to-face encounter (other than with respect to encounters in wh ich “incident to” services are involved) with the benefici ary. “Incident to” services are defined in section 1861(s)(2) (A) of the Act. Likewise, for the purpose of this regula tion, a face-to-face encount er must be documented by a physician and any encounter that is covered as an “incident to” service does not satisfy the requirements of this regulation. The following is a summary of the comments we received regarding the documentation of a face-to-face encounter and the ti meframe in which it must occur.
Comment : Many commenters suggested that CMS revi se the rule to require that face-toface encounters occur only before the date of the written order, and not after the written order is issued. Response : After consideration of these commen ts we have removed the option for the face-to-face encounter to occur 30 days after the written order. We believe it is critical that the face-to-face be conducted before the item is delivered to the beneficiary’s home. Allowing faceto-face encounters to occur 30 days after the orde r could result in medically unnecessary items being delivered to beneficiaries. Further, supplie rs could deliver the item but then be unable to bill Medicare if the face-to-face encounter does not occur.
Comment : Many commenters believed the timeframe should be revised to allow the face-to-face encounter to occur in the 6-month pe riod preceding the order, as authorized by the

statute.765
Response : In response to comments, CMS is modi fying the encounter timeframe so that the face-to-face encounter must now occur 6 months prior to the written order, as opposed to the 3 months we previously had proposed. We belie ve this modified timeframe best balances the need to protect the Medicare Trust Funds by limiting waste, fraud and abuse while limiting burden.
Comment : Many commenters stated th at the 30 days after the wr itten order specifically puts the suppliers at financial risk. Many comment ers expressed concern that it is not reasonable to expect suppliers to furnish the item without documentation th at the in-person encounter took place. Once a beneficiary has received the Specifie d Covered Item of DME, he or she has little incentive to see a doctor. The supplier, meanwh ile, will not be paid for the item unless it has obtained a signed Advance Beneficiary Notice of Noncoverage (ABN) from the beneficiary. Therefore, many commenters suggested that the face-to-face encounter should not be allowed to occur after the written order and delivery of the Specified Covere d Item. They believed neither the beneficiary, nor the physician will have much impetus to follow through with the encounter once the equipment is delivered, and the supplier will then be unable to bill Medicare. A few commenters suggested that if th e timeframe is not revised, CMS should compensate suppliers for the first 30 days if the physicia n does not present documentation. Response : We concur that it is critical that the face-to-face encounter be conducted before the item is furnished to the beneficiar y’s home. We are revising the timeframe for the face-to-face encounter to occur and removing the 30 days after the written order. The face-toface encounter must occur in the 6 months before the order is written. We will not offer any compensation or liability waivers because th e supplier should be able to obtain the documentation before supplying the item.
Comment : A few commenters suggested that if the timeframe is not revised, CMS must766 make clear that suppliers would be entitled to pa yment under the waiver of liability provisions in section 1879(a)(1) of the Act in the event that the benefici ary does not follow through with the face-to-face visit, as the DME s upplier would have no way to know that the visit would not take place. According to the commenters, section 1879(a )(1) clearly states that if a contractor denies payment because of a determination that the services was medically unnecessary, which would include a denial for a lack of a face-to-face encounter, the supplie r should nonetheless be paid if the supplier did not know and had no reason to know that the payment would be denied. Response : As noted previously, we are revising the encounter timeframe to be in the 6 months before the DME order is written. We belie ve it is critical that the face-to-face encounter be conducted before the item is delivered to the beneficiary’s home. Sin ce we have removed the 30 days after the order requirement, the waiver of liability provisions do not need to be addressed.
Comment: Several practitioner organizations sup ported the proposed 90 days before or 30 days after the order is writt en timeframe for the face-to-face encounter. These commenters believed it was a reasonable timeframe for the face-to-face to occur. Response : The vast majority of commenters expressed concerns about the proposed timeframe. The supplier industry specifically expressed serious concerns regarding the provision in the proposed rule that allowed the face-to-face or der to occur 30 days after the written order. Therefore, with this final rule with comment period, we are elim inating the option for the faceto-face encounter to occur 30 days after the writt en order and revising the timeframe for a faceto-face encounter to occur 6 months preceding the written order. We will monitor the implementation of this rule to ensure there are no unintended consequences that negatively impact the practitio ner, supplier, and beneficiary communities. In addition, we do not believe the new timeframe will have a significant impact on beneficiaries’767 access to medically necessary, quality DME, sin ce we believe that many beneficiaries already see their practitioner during a 6-month period of time. We believe the new timeframe will make it easier for beneficiaries to access DME then the previously proposed timeframe.
Comment : A few commenters cautioned that this proposal will cause a certain amount of confusion since certain DME items, such as po wer mobility devices (PMDs) as outlined in §410.38(c), have a 45 day face-to-fac e encounter requirement as opposed to the proposed 90 day requirement for other DME items. Commenters believe greater consis tency among face-to-face requirements for DME will reduce confusion and improve compliance by healthcare professionals. Several commenters expressed a desire to have th is regulation supersede the PMD face-to-face regulation. Response: This regulation implements section 18 34(a)(11)(B) of the Act. It does not supersede the PMD regulation as specified in §410.38(c), which we issued under different authority. We believe that a longer timeframe is necessary for these DME items than the 45-day timeframe for PMDs because of the wide variet y of DME items covered by this rule. This regulation does not apply to PMDs and does not supersede other regulations specific to PMDs. We look forward to engaging in extensive educa tion to help to clarif y the requirements.
Comment : Several commenters suggested that CMS should consider a risk-based approach where specified conditions would be excluded from the face-to-face encounter requirement within the proposed timeframe. Pr ior to finalizing the proposed rule, most commenters suggested that CM S should work more closely with physicians and supplier stakeholders to determine the best approach in establishing a timeframe for the face-to-face

encounter. Response : In response to comments, we have removed the requirement allowing the face-to-face encounter to occur 30 da ys after the written order and instead are requiring the face-768 to-face to be conducted in the 6 months preceding th e written order. However, we are not using a risk based approach to determine the me thodology and timeframe for the DME face-to-face requirement. We believe that a risk based appr oach would be difficult to implement and would create undue confusion. We further believe that it is unnecessary particularly in light of the longer timeframe.
Comment : Several commenters expressed conc erns that the longstanding Medicare policy allows beneficiaries to receive items they urgently need by allowing verbal communication between practitioners and suppliers; then a written order is required before billing. Commenters caution that the coverage po licy should not prevent Medicare beneficiaries from receiving statutorily-covere d, medically necessary items. Response : We do not believe this provision will prevent Medicare beneficiaries from receiving medically necessary DME. Regarding the longstanding policy, outlined in the Program Integrity Manual, Chapter 5, for items that do not require a written order before delivery, suppliers are allowed to dispense DME to the beneficiary based upon a verbal order, however a supplier must have a written order before submitting a claim for payment. For items that do require a written order befo re delivery, a supplier must have a written order (with the face-to-face documentation) prior to delivery when submitting a claim for payment. This provision will ensure that beneficiaries are on ly receiving medically necessary DME. We encourage open communication between the prac titioners and suppliers to ensure that beneficiaries receive medically necessary items in a timely fashion. In addition, we will monitor the implementation of this rule to ensure ther e are no unintended consequences that negatively impact the beneficiary, practitioner and supplier communities.
Comment : Several commenters believe that the ag ency is implementing a flawed statute, and urge the Secretary to carefully consider the impact on patients, particularly in rural and urban769 underserved areas. These commenters were especi ally concerned that NPs and Clinical Nurse Midwives (CNMs) are not able to fulfill the face-to-face requirement for DME. Commenters cautioned that ordering DME is clea rly an activity that is within the scope of practice of nurse practitioners. They believed th at a statutory barrier preven ting nurse practitioners from independently documenting face-to-face encounters limits the agency and, most importantly, the patient’s ability to receive timely and important care. Response : We recognize the concerns commenters have expressed regarding the impact that this statute might have on beneficiaries, pa rticularly in rural and urban underserved areas if NPs are not allowed to fulfill the face-to-face requirement. NPs, PAs, and CNSs can still conduct the face-to-face encounter a nd order DME within their scope of practice. However, in this final rule, we are implementing the statutory requirement in section 18 34(a)(11)(B)(ii) of the Act, that a physician must document that the face-to-f ace encounter occurred when performed by a PA, NP, or CNS. CNMs are not listed in th e statute as a practiti oner that may conduct the face-to-face encounter. Moreover, we belie ve that CNMs are di stinct from CNSs.
Comment : A few commenters expressed concerns that NPs have no control over how quickly physicians will actually document the f ace-to-face encounters that they conduct. The commenters were concerned that there may be inst ances in which it will be difficult to ensure documentation is submitted by the physician to the supplier within 30 days after an order is written, potentially delaying patient access to th e equipment they need while documentation is being completed. Response : We have removed the ability for the face-to-face encounter to occur up to 30 days after the order. We are implementing a statutory requirement th at the physician must document the face-to-face encounter even when pe rformed by a PA, NP or CNS within the 6 months preceding the written orde r. We urge physicians, PAs, NP s and CNSs to work together770

to ensure that all beneficiaries receive needed DME. Additionally, we believe that 6 months prior to the written order provi des sufficient time for coordination between the NP, PA, or CNS and the physician to document the face-to-face en counter. In addition, we will monitor the implementation of this rule to ensure there are no unintended conse quences that negatively impact the practitioner, supplie r, and beneficiary communities.
Comment : Several commenters stated that CMS should assume that practitioners’ medical judgment determined that the face-to-face encounter is valid. Response : We appreciate the commenters’ r ecommendation that physicians/treating practitioners should be given the presumption th at their medical judgment determined that the face-to-face encounter is valid or medically necessary. However, we must ensure that all CMS requirements are met, and cannot accept this re commendation. Therefore, just because a face-toface encounter is performed does not mean that all CMS requirements are met, including medical necessity.
Comment : Several commenters expressed concern that there is no evidence that requirements for physician oversight or supervisi on increases quality or reduces fraud. The commenter further stated that duri ng the past 15 years, th ere is little evidence that NPs and CNSs engaged in fraudulent or abusive ordering of DME and there is little efficiency or true accountability in relying on documentation by a physician who has not evaluated the patient rather than the NP or CNS who has performed that examination. Response : This rule does not address the orde ring practices of NPs and CNSs. Rather, the statute requires that physicians document the face-to-face encounters of NPs, CNSs and PAs with beneficiaries for certain covered items of DME. Section 1834(a)(1 1)(B)(ii) of the Act requires that a physic ian must document that the face-to-face encounter occurred when performed by a PA, NP, or CNS. The degree to which NPs and CNSs ar e engaged in fraudulent771 or abusive ordering of DME is not specifically ad dressed by this Affordable Care Act provision; however, as we stated earlier and also in the pr oposed rule, we believe that requiring a face-toface encounter that supports the need for the c overed item of DME will re duce the risk of fraud, waste, and abuse since these visits help ensu re that a beneficiary’ s condition warrants the covered item of DME.
Comment : Several commenters stated that for some beneficiaries needing items such as transcutaneous electrical ne rve stimulation (TENS), it is common for physical therapists, occupational therapists, chiropracto rs, and other participating Medica re health care professionals to conduct the face-to-face encounter while physicia ns continue to be responsible for producing the written order and documenting that the face-to-face encounter has occurred. A few commenters stated that it should be sufficient for a speech pathol ogist to conduct the face-to-face encounter for items such as a speech generating device. A few commente rs stated that sleep physicians should also be allowed to provide DME. Response : We appreciate these commenters’ sugge stions regarding including additional types of practitioners that could potentially prov ide DME face-to-face encounters. It is important to keep in mind that chiropractors are not al lowed to bill Medicare for DME items. Other practitioners must be working with in their scope of prac tice. The statute specifies that while the physician must document his or her own face-to-face encounter, only a physician, NP, PA, or CNS may conduct the face to face encounter, howe ver it must be documented by a physician. Moreover, a sleep physician who meets the Medicar e definition of physician can be considered a physician for purposes of this face-to-face encounter.
Comment : Several commenters stated that if this rule is to prevent fraud on the physician/non-physician side, then having a strong rationale for the DME equipment in their encounter note should provide sufficient documen tation to determine the medical need for the772 DME. The commenters believe this documentation establishes the trail of the request and justification for each piece of DME. No additional paperw ork should be transmitted and no interpretation of the encounter note (by non-clinician DME supp liers) would need to be done. The process could create a clear a uditing trail for investigators. Response : We appreciate these comments; however, we must implement the regulation based on the provisions of secti on 1834(a)(11)(B)(ii) of the Act, which requires a physician to document the occurrence of a face-to-face encoun ter for covered items of DME. Throughout the development of the proposed rule and base d on comments, we attempted to balance the implementation of the statute while limiting burde n on providers, suppliers and beneficiaries, and while ensuring that beneficiaries continued to have access to medically necessary DME. In response to comments, we removed language that allowed the face-to-face encounter to occur 30 days after the writ ten order and modified the time frame to now be within the 6 months preceding the written orde r. We believe that this wi ll allow suppliers to deliver medically necessary DME while trying to eliminate the possibility that th e face-to-face encounter will never be conducted. In the proposed rule, we noted that a face- to-face encounter may be accomplished via a telehealth encounter if all Medi care telehealth requirements as defined under section 1834(m) of the Act and the implementing regulations in §410.78 and §414.65 are met as described in more detail in the CY 2013 PFS proposed rule (77 FR 44794). Further, a single face-to-face encounter, including those facilita ted through the appropriate use of telehealth, can support the need for multiple covered items of DME as l ong as it is clearly docum ented in the pertinent medical record that the benefici ary was evaluated or treated fo r a condition that supports the need for each covered item, dur ing the specified timeframe.773

As described in more detail in the CY 2013 PFS proposed rule (77 FR 44795), we proposed requirements for a written order as a co ndition of payment. For purposes of this final rule with comment period, which is focused on implementing section 1834(a)(11)(B) of the Act and reducing fraud, waste, and abuse, an order without minimum elements would be considered incomplete and would not support a claim for payment. The following is a summary of the comments we received regardi ng the written order proposal.
Comment : Many commenters expressed a belief that instructions and requirements related to the order need to be clear and less burdensome. Co mmenters expressed the need for clarity and/or requested removal of the need fo r physicians to describe “necessary and proper usage instructions”, diagnosis codes, and the Na tional Provider Identifier (NPI) in the written order. Response : We appreciate the commenters’ recomme ndation. We agree that instructions that limit burden are important. We have re moved the proposed requirement for orders to include: “necessary and proper usage instructions” and the dia gnosis. Due to the large number of covered DME items and the fact that there could be many dia gnoses and usage instructions for each, we agree that these proposed requirement s may be overly burdensome. While this information will not be required on the DME order under this regulation, we will still expect to see related diagnoses included in the beneficiary’s medical reco rd. We would also expect “necessary and proper usage instructions” to be provided to the beneficiary or care giver for proper usage of the item. The remaining five el ements listed: (1) the beneficiary name; (2) the item of DME ordered; (3) prescribing practitione r NPI; (4) the signature of the prescribing practitioner; and (5) the date of the order are the minimum needed for CMS to consider the order valid. This does not supers ede other requirements.774

Comment : Several commenters stated that for some DME items, the proposed face-toface encounter requirements represent a significant change for Medicare be neficiaries, providers and DME suppliers. Commenters noted that even though some of the proposals are relatively minor, such as requiring the prescr ibing practitioner’s NPI to be included on the written orders, they require providers and supplie rs to change their standard practices. Such “minor” changes are significant since non-com pliance may adversely affect the payment for DME. Response : We appreciate these comments. Ou r goal is to limit provider and supplier burden while still preventing waste, fraud and abus e. To that end, in response to comments, we have removed the requirement that instructions for necessary and proper usage, and the diagnosis be included on the order. Howeve r, we are retaining the other requirements as a way to limit waste, fraud and abuse. As a result of the comments, we are requiring at a minimum, the written order contains: (1) the beneficiary name; (2) the item of DME ordered; (3) the signature of the prescribing practitioner; (4) prescribing practi tioner NPI; (5)the date of the or der. Orders should still comply with standards of practice and therefore may be more detailed. As noted previously, section 1834(h)(3) of the Act incorporates by cross reference prosthetic devices, orthotics, and prosthetics to the items encompasse d by section 1834(a)(11)(B) of the Act. At this time, we are not impleme nting the proposed changes to §410.36(b) to require documentation of a face-to-face encounter for prosthet ic devices, orthotics, and prosthetics that, according to §410.36(b), require a written order before delivery in this final rule. We intend to use future rulemaking to determine which prosthe tic devices, orthotics, an d prosthetics, require, as a condition of payment, a written order before delivery supported by do cumentation of a faceto-face encounter with the beneficiary consistent with section 1834(a)(11) (B)(ii) of the Act. The following is a summary of comments we received regarding prosthetic devices,775 orthotics, and prosthetics.
Comment : In many cases, the acute condition (f or example, amputation, stroke, polio, etc.) that caused the initial medi cal need for the prosthesis or or thotics no longer requires specific medical treatment by a physician. In this scenar io, Medicare beneficiar ies often look to their orthotist or prosthetist to conti nue to provide the pros thetics or orthotics (P & O) necessary to restore and maintain functional abilities. Commen ters were concerned that if applied to P & O patients, the face-to-face requirement for P & O care would result in extensive administrative burdens for P & O clinicians and the physicians who prescribe thes e services, as well as pose a significant impediment for their patients. Response : We appreciate this comment and will c onsider it as we contemplate future rule making for P & O.
Comment : For prosthetic devices, orthotics, an d prosthetics, comme nters urged CMS to conduct an evaluation of the impact of the requi rements for selected DME items before deciding whether there should be any expansion to other product categories. Second, commenters believed that CMS should limit any such requireme nt to items for which there is sufficient evidence of fraud and abuse, and not based so lely on the reimbursement amount of the item. Commenters continued to have c oncerns about what data CMS used to establish and verify the level of fraud among Medicare physicians, specifi cally as related to that data comparing physician suppliers vs. commercial suppliers, an d by specialty area within physician suppliers.Several commenters noted that when CMS considers whether to apply the new face-toface encounter requirements to enteral nutri tion, CMS should be mindful of the existing requirements and not impose redundant requirem ents or request duplicative information. Response : We appreciate these comments, and will consider them, including physician vs. commercial suppliers, as we consid er future rule making for P & O.776 We also stated in the proposed rule that none of our proposals supe rseded any regulatory requirements that more specifically address a face -to-face encounter requir ement for a particular item of DME. (2) Physician Documentation The statute requires that a physician document th at the physician or a PA, NP or CNS has had a face-to-face encounter with the beneficiary. As described in the CY 2013 PFS proposed rule (77 FR 44795), we proposed two options for how this could be done. The following is a summary of the comment s we received regarding the physician documentation proposal.
Comment : Several commenters believed a st andardized form that documents the elements CMS and its contractors require for coverage of a DME item should be recognized by CMS as part of the beneficiary’ s medical record and should esta blish the beneficiary’s medical need for the item. Response : The amount of necessary clinical informati on needed to demonstrate that all coverage and coding requirements are met will vary depending on the item/service. For example, we have National and Local Coverage Determinations which address many of these items/services. The commenters appear to be describing a template. However, we do not prohibit the use of templates to facilitate recordkeeping. We also do not endorse or approve any part icular templates. A physician or practitioner may choose any template to assist in documenting medical information. We do caution, however, that some templates provide limited options and/or space for the collection of information such as by using “check box es,” predefined answers, and limited space to enter information. We discourage the use of such templa tes. Our experience with claim review shows that ‘limited space’ templates often fail to capture sufficien t detailed clinical information to demonstrate that all coverage and coding requirements are met. Furthermore, physicia ns or practitioners should be aware that templates designed to gather selected inform ation primarily for reimbursement purposes are often777
insufficient to demonstrate that all coverage and coding requirements are met. These ‘limited space’ documents often do not provide sufficient comprehens ive information to adequately show that the medical necessity criteria for the item/service have been met. Comment: A few commenters expressed a belie f that the documentation requirements should be the same for physicians as they ar e for nurse practitioners and other non-physician providers. Response : We agree that the documentation requi rements for the face-to-face encounter should be the same. However, it is duplicative to have the phys ician document that the face-toface occurred when they themselves conducted th e face-to-face encounter. Therefore, we are not requiring additional documentation requirements for the physician in addition to what they are required to document during the actual face-to-face encounter. As a result of the comments, the submission of the pertinent portion of the medical record documented by the physician is sufficient to doc ument that the face-t o-face encounter has occurred, when the physician conduc ts the face-to-face encounter. Documentation of the faceto-face encounter must include an evaluation of the beneficiary, needs assessment for the beneficiary, or treatment of the beneficiary for the medical condition that supports the need for each covered item of DME. A written order is s till required for these covered items of DME. (3) Physician Documentation of Face-to-Face En counters Performed by a Physician Assistant, Nurse Practitioner, or Clinical Nurse Specialist As described in the CY 2013 PFS proposed rule (77 FR 44795), we had considered four options for the physician documentation of a f ace-to-face encounter perf ormed by a PA, NP, or
CNS. The following is a summary of the comments we received regarding how physician documentation requirements should be handled when the face-to-face encounter with the beneficiary is conducted by a PA, NP, or CNS.778

Comment : Many commenters believed that CMS should allow each of the outlined options so that practices may choose which optio n will best meet their needs and those of the patient. Response : We believe there needs to be a stan dard accepted practice for documenting the face-to-face encounter when performed by a PA, NP or CNS. We believe th at this will promote consistency and ensure that there is clear guidance on the requirements.
Comment : Some commenters believe that if an ordering physician certif ies the date of a face-to-face encounter on the signed written orde r that should be sufficient documentation for the supplier to establish medical necessity for th e DME items. This method of documentation is most efficient for physicians, and it is easily ve rified by DME suppliers when establishing that medical necessity requirements are met. Response : While we appreciate this comment, a ve rification of a date added to a written order does not prove that an adequate face- to-face occurred. De tailed face-to-face documentation is required to ensure the item of DME is medically necessary and appropriate for the individual beneficiary.
Comment : Commenters believe there is no justification for requiring less information on the beneficiary’s medical need for DME if a physic ian personally conducts the evaluation than if a nurse practitioner assesses the patient. Typically, the physician communicates the order directly to the supplier who, in turn, initiates intake and assessment based on a written confirmation of the physician’s verbal order, wh ich is later ratified by the physician’s signature and date. Response : We are not requiring less informati on on the need for DME if a physician conducts the evaluation than would be deemed a ppropriate if a nurse pr actitioner assesses the patient. We are not requiring additional documentation requirements for the physician above779 what they are required to perform in documenting the ac tual face-to-face encounter.
Comment : Many commenters expressed a desire to limit their burden. Commenters expressed that overly unnecessa ry copying, drafting, and distri bution of records from the MD/DO to the physician supplier is burdensome at th e very least, interferes with the physicianpatient relationship, and is genera lly not in the best interests of the Medicare beneficiary. Response : We have worked to develop a rule th at weighs our responsibility to implement the statutory provision, while minimizing provider and supplie r burden. As a result of comments, we are allowing flexibility on how the supplier is notified of the face-to-face encounter. We have tried to limit the burden by requiring that the physi cian sign/cosign the pertinent portion of the medical record to document when a face-to-face encounter was performed by a NP, PA or CNS. This step is not needed when the physician personally conducts the face-to-face encounter. As a result of the comments, we are requiri ng the physician documenting the face-to-face encounter performed by a NP, PA or CNS, must sign or cosign the pertinent portion of the medical record indicating the occurrence of a f ace-to-face encounter for the beneficiary for the date of the face-to-face encounter, thereby docum enting that the beneficiary was evaluated or treated for a condition relevant to an item of DME on that date of service. Other signature requirements described in the manual, such as thos e for determining a legible signature remain in force. This option provides evidence that the physician reviewed the relevant documentation to support that a face-to-face encounter occurred for that date of service. A signed order (in contrast to a signed medical reco rd) would not satisfy the requir ement described in this option that the physician “sign/cosign the pertin ent portion of the medical record.” (4) Supplier Notification Since the supplier submits the claims for th e covered items of DME, the supplier must780

have access to the documentation of the face-to-face encounter. All documentation to support the appropriateness of the item of DME ordered, including documentation of the face-to-face encounter, must be available to the supplier. As with certain other items and services submitted for Medicare payment, we require the entity submitting the claim to maintain access to the written order and supporting documentation relating to written orders for covered items of DME and provide them to us upon our request or at the request of our contractors. As described in CY 2013 PFS proposed rule (77 FR 44795), we had considered four options for the supplier notificati on of the face-to-face encounter. The following is a summary of the comment s we received rega rding the supplier notification proposal.
Comment : Several commenters expressed conc erns that physicians have reported deceptive practices by DME suppliers who have sent letters to physicians on letterhead appearing to be co-branded with CMS but withou t CMS authorization. The letters have indicated that because the DME supplier is undergoing a CM S audit, the physician must produce extensive and costly medical record documentati on and submit it to the DME supplier. Response : Suppliers are required to have the documentation available upon request by CMS. CMS has worked to limit the burden associat ed with this regulation. However, the CMS seal and logo are for the official use of CMS and its au thorized contractors only and must not be used by suppliers or others within the private s ector. Under section 1140 of the Act, individuals or organizations may be subject to a civil money penalty for the misuse of words, symbols, or emblems or names in reference to Social Securi ty or Medicare. If physicians have information about suppliers or others who are misusing CM S words, symbols, or emblems, they should contact the HHS Office of Inspector General. Organizations or indivi duals concerned about suppliers who may be misreprese nting themselves or CMS should contact the contractor that781 processes their claims. CMS requires that supplie rs have access to the documentation to support their claims. Suppliers may request supporti ng documentation, including documentation of a face-to-face encounter, from the physician, but supp liers must not misuse CMS words, symbols, or emblems when making those requests. S uppliers may, of course, share unaltered CMS educational material.
Comment : Commenters suggested that CMS cl arify in its regulation that after a physician or beneficiary has submitted a medical record and documentation of the face-to-face visit to the DME supplier, the DME supplier must retain a copy of that already-submitted record, and the physician is not required to supply subsequent medical re cords or documentation to the DME supplier. Response : The face-to-face encounter is a condi tion of payment for the supplier. Suppliers must make this information available to CMS upon request.
Comment : Commenters urged CMS to give physi cians and other practitioners maximum flexibility by allowing them to choose among th e options CMS has proposed. To avoid creating new burdens for physicians, commenters recomme nd that the new proces s for communicating documentation to suppliers resemble, as closel y as possible, current processes used by physicians. Commenters believe that this may be similar to the second option discussed in the proposed rule, and, if this is the case, they recommended using that option. Response : In response to comments, we are not requiring a part icular method of transmission for supplier notification that the f ace-to-face encounter has occurred in order to limit burden and not create a hindrance to access to care. Practitione rs and suppliers can communicate the information and requirement s through existing business processes for transmitting this information. CMS will monitor th e effects of this provi sion on beneficiaries’ access to medically necessary DME. We also note that this documentation must be made782 available to suppliers to allow them to ensure a ll requirements are met. Suppliers must make this documentation available to CMS upon request.
Comment : Many commenters believe that the adopted rules should give adequate protection to downstream DME su ppliers who act in good faith in response to information communicated by physician practices. Commenters believe that whatever documentation and communication policies CMS adopts for face-to-face encounters should give suppliers absolute peace of mind that their subsequent dispersing of DME items will not later be second-guessed by CMS or its contractors. Response : We believe that by removing the abil ity for the face-to-face encounter to occur 30 days after the written order suppliers will be afforded more protection as all documentation will be available at the time of order. Completion of the face-to-face requirement is a condition of payment and could be subject to audit. Therefore, this documentation must be available to CMS on request. CMS will monitor th e effects of this provision on beneficiaries’ access to medically necessary DME.
Comment : A few commenters strongly opposed the fourth option of requiring the physician to provide a copy of th e face-to-face documentation to the beneficiary and disagreed with the reasoning that this opti on would, “ensure that the supplie r receives the documentation of face-to-face encounter directly and limits the supp lier’s need to rely on the PA, NP, or CNS to receive this documentation co mpleted by the physician.” Response : We appreciate this concern, and therefore, will not require this particular method for transmission of this communication.
Comment : Several commenters expressed a con cern that the orderi ng practitioner has little interest or incentive to ensure the necessary paperwork is provided to the supplier since the practitioner/physician still gets re imbursed for their services rega rdless of whether they have783 inadequate documentation and fail to provide such documentation to the suppliers. A few commenters stated that the DME supplier should not be responsible for scheduling the face-toface visits to ensure the requirement is met. Commenters also believed physicians who are continually noncompliant with the rule should be subject to corrective action. Response : We encourage suppliers and practitione rs to work together to ensure that beneficiaries receive necessary a nd appropriate care. Completion of the face-to-face requirement is a condition of payment. Therefore, this documentation must be available to CMS upon request. We believe that by removing the 30 days after the order is written timeframe for the face-to-face encounter, the supplier w ill be able to know before delivery if all requirements have been meet. CMS does provide education on docum entation requirements to physicians and other practitioners including through MLN articles. As a result of the comments received, we ar e not requiring a particul ar method of supplier notification. Instead, since this is a condition of payment, we onl y require that the supplier must have all documentation to support the claim upon re quest. We believe this will limit the burden on practitioners and suppliers while helping to ensure beneficiary access to DME. b. Covered Items Section 1834(a)(11)(B)(i) of the Act (as re designated by the Affordable Care Act authorizes us to specify covered items that require a written order prior to delivery of the item. Under section 1834(a)(11)(B)( ii) of the Act, these orders must be written pursuant to a physician documenting that a face-to-face en counter has occurred. Accord ingly, to reduce the risk of fraud, waste, and abuse, we proposed a list of Specified Covered Items that would require a written order prior to delivery. Ou r final list of Specified Covered It ems is in Table 89. In future years, updates to this list will appear annually in the Federal Register and the full updated list will be available on the CMS website.784 As highlighted in the January 2007 Govern ment Accountability Office (GAO) report entitled, “Improvements Needed to Address Improper Payments for Medical Equipment and Supplies,” it is estimated that there were $700 million in improper payments across the spectrum of DMEPOS from April 1, 2005, through March 31, 2006. GAO did not specifically recommend the use of DME face-to-face encounters as a reme dial action in its repo rt. However, the GAO did recommend making improvements to address im proper payments in the DMEPOS arena. This final rule with comment period is one way in which we are working to prevent DME improper payments. Though we initially considered making all items encompassed by section 1834(a)(11)(B) of the Act (including prosthetic and orthotic it ems described in section 1834(h)(3) of the Act) subject to a face-to-face encounterrequirement, we have first proposed a more limited criteriadriven list to balance a comprehensive face-t o-face requirement to prevent fraud, waste, and abuse while mitigating any undue negative effect on practitioners and suppliers by including all items. We welcomed comments on limiting the a ssociated burden of this proposed rule by refining the number of items subject to a f ace-to-face encounter, while still protecting the Medicare Trust Funds. The following is a summary of the comments we received regarding the covered items proposal.
Comment : Commenters appreciated CMS’s effo rts to reduce fraud, waste, and abuse. Commenters expressed that “ as CMS implicitly acknowledges” in the preamble to the proposed rule that the statute does not compel the Secretary to require a written orde r prior to delivery for all DME. Rather, the Secretary “is authorized” to require a written order prior to delivery for DME items that are “specified covered items”. However, for any DME items that are Specified Covered Items, the Secretary is obligated to require documentation by a physician that the order785

is based on a face-to-face encounter between the beneficiary and an authorized practitioner. Commenters stated that CMS should apply the new encounter and documentation requirements initially to a smaller number of HCPCS codes and first evaluate the impact of the requirements on beneficiary access to DME and costs to provide rs before expanding the list in the future. Commenters suggested the new face-to-face en counter requirements should not apply to instances where a physician is orde ring an item of DME that is substantially similar to the item already being used by the beneficiary. Response : We believe that this is an important provision aimed at reducing fraud, waste, and abuse. We used a criterion driven appro ach to select these items, and did not receive sufficiently detailed alternative criteria to those proposed. We be lieve limiting new face-to-face encounter requirements only to instances where a physician is ordering an item of DME that is substantially similar to the item already being us ed by the beneficiary is insufficiently broad to make significant inroads into reducing fraud, wast e and abuse. It would also be difficult to determine and what qualifies as “substantially similar.”
Comment : Commenters stated that requiri ng that a physician sign-off on commonly prescribed items, such as blood glucose monitors and standard wheelchai rs that are currently ordered by NP, PA, and Advance Practice Nurses including CNSs may create a barrier for consumers, many of whom routinely receiv e this needed equipment from nonphysician practitioners , and runs contra ry to current Medicare reim bursement practice. Several commenters raised concerns that the agency’s broad list of proposed covered items includes several items that NPs and CNSs order routinely for frequent conditions and diagnoses, such as glucose monitors. Commenters stated that re quiring physician documentation before these items may be supplied is likely to delay patient care and potentially lead to serious complications and more severe conditions.786
Response : We are implementing the statutory requi rements of this provision to require a physician has to document the occurrence of a face -to-face encounter for certain covered items of DME. Face-to-face encounters conducted by NP s, PAs, and CNS are allowed, but as the statute states these encounters must be docum ented by a physician. CMS does not believe that this regulation will create a barrier to beneficiar ies including those who are prescribed orders from PAs, NPs and Advance Practice Re gistered Nurses including CNSs . We use a criterion driven approach to se lect these items and are implementing this provision in accordance with the st atute. We do not believe that this requirement will delay a beneficiary from getting necessary care particular ly with the longer timeframe. In addition, we will monitor the implementation of this rule to ensure there are no unintended consequences that negatively impact the practitioner, supplier, and beneficiary communities.
Comment : Commenters recommended that CMS exercise its discretion and create a smaller list. Commenters suggested excluding from the list of Specified Covered Items any DME covered under an NCD or LCD that requires a physician to see the beneficiary before ordering the item. These include oxyge n and oxygen equipment (E0441, E0442, E0443, and E0444) and all ventilators in cluding CPAPs and RADs. Additionally, commenters recommended any item s necessary to ensure a safe discharge from an inpatient stay and preserve continuity of care, including wheel chairs, infusion pumps, hospital beds and accessories, negative pressure wound therapy (NPWT), and ambulatory items, be excluded from the list of Specified Covered Items. Commenters stated that the need for glucometers and nebulizers (E0570, E0575, E0580) for this population is obvious; if translated to office or clinic visits needed to monitor then in the absence of the availability of this equipment, or even the extra time it will take physicians and nurse practitioners to obtain th e extra documentation to order these items. This represents a787 significant amount of unnecessary time and cost with poorer patient outcomes. Many commenters expressed the view that a face-to-face encounter for speech generating device (SGD) should be excluded sin ce it will adversely affect an aphasia patient’s ability to obtain the equipment required for function co mmunication. They believe the face-to-face encounter requirement is an undue hardship fo r people needing a speech generating device. A SGD already requires a Certificate of Medical Necessity before ordering. Commenters noted the current proposed lis t of Specified Covered Items includes equipment that have a fee schedule amount well below $1000, including accessories to the primary equipment. To require a separate face-to-face encounter to document need for an accessory for primary equipment already vetted in a previous face-to-face encounter and currently in the possession of the benefici ary seems unduly burdensome. To that point, commenters stated, that wheelchai r accessories should not be incl uded on the Specified Covered Item list. Section 410.38 (c)(3)( ii) states that accessories fo r PMDs may be ordered by the physician/treating practitioner without conducting a face-to-face encounter with the beneficiary. Response : In areas where a face-to-face is required by the NCD or LCD the documentation requirements of this regulation are in addition to those documents for the NCD or LCD. The face-to-face should comply with the requirements of the applicable NCD/ LCD and its occurrence must be documented by a physicia n. CMS reminds providers and suppliers that multiple items can be supported by a single face-to- face encounter. For a beneficiary who is disc harged from the hospital, th e face-to-face encounter may occur in that setting. This mitigates the con cern of items needed to safely discharge the beneficiary. We are removing items from the covered list of items where regulations explicitly state that a face-to-face encounter is not necessary such as power wheel chair accessories. We used a788 criteria-driven approach in order to create this list, and speech generating devices specifically are items meet one of our criteria. There are it ems below $1,000 on the list because these items still have an aggregate effect on the Medicare Tr ust Funds. While commenters recommended we remove individual items, we are not convinced that any of our crit eria are inappropriate.
Comment : Some commenters supported the inclusion of ventilat ors, respiratory assist device CPAP/ BiPAP, and chest wall oscillators on the list of items that require a face-to-face

encounter. Response : We agree and have included these items on the Specified Covered Item list.
Comment : Commenters questioned if aggregat e rental cost was included in the $1000 threshold. Response : The threshold criterion does not incl ude aggregate rental costs of DME.
Comment : Many commenters believe the overwhelm ing majority of orders for DME are already made in an appropriate medical context. That is, DME is typically ordered as part of a beneficiary’s routine medical care consistent w ith coverage determinations issued by CMS and its contractors. Consequently, they believe it is unnecessary for CMS to require additional inperson evaluations or documentation for many cat egories of DME. Moreover, when DME is ordered on discharge from an i npatient stay, they believe it is likewise unnecessary for CMS to impose an additional face-to-face physician visit or documentation requirement because the beneficiary’s need for equipment would have been evaluated during the stay. Other similar comments are that the face-to-face encounter requir ements will generate c onsiderable additional administrative burden for physicians, patients and suppliers, and overall he althcare costs due to increases patient morbidities as a result of expired prescriptions or inability to obtain documentation that will delay getting DME. Fina lly, commenters believed there is no hard evidence that this provision w ill have a positive impact.789
Response : We are implementing the statutory requirement using a criteria-driven approach in order to create this list. We have taken into account many of the comments received in revising the rule to addre ss the potential burden c oncerns, extending the proposed timeline to 6 months, removing the 30 days post written order option, and allowing face to face encounters to occur at the hospital prior to discharge. While commenters re commended removal of individual items, there was no mention of removing any of the specific criteria, nor was a detailed alternative methodology provided. While comm enters recommended individual items to remove, we must maintain a crite ria-driven approach our criteria were outlined in 77 FR 44797.
Comment : Commenters were very concerned that the proposed rule does not make clear that the burden to obtain documentation of face -to-face encounters will not be placed on pharmacies. Response : We worked to implement this statute in a way that limits burden to providers and suppliers while ensuring beneficiary access to care. All entities b illing Medicare for a covered item of DME are subject to this provision. CMS does not be lieve that it is appropriate to carve out an exception for pharmacies. If a pharmacy bills Medicare for one of these covered items then this documentation must be available upon request.
Comment : Commenters encouraged the Agency to (1) assess regularly how additional documentation requirements could limit patient access to DME items and increase the documentation burden on providers, (2) describe what types of educational programs it will develop to help providers understand the DME documentation requirements necessary for Medicare coverage, and (3) evalua te what incentives could be offe red to encourage providers to focus on reducing documentation error rates. Response : We do not believe that this requirement will limit patient access to necessary DME particularly in light of the longer timefr ame. We balanced the need to protect the790 Medicare Trust Funds while limiting burden. We ar e not being prescriptive on how the face-toface encounter must be communicated to the supp lier and believe this will help limit provider burden. CMS will issue an MLN article regarding this requirement. Incentives for document error rate are outside the sc ope of this regulation. As a result of the comments, we are maintaini ng our criteria- driven list, however, we are removing items from the covered lis t of items where regulations e xplicitly state that a face-toface encounter is not necessary. As described in the CY 2013 PFS proposed rule (77 FR 44796), we described our proposed criteria, as well as the reasons we sele cted these criteria. We first noted that our proposed list of Specified Covered Items contai ns DME items only. We intended to use future rulemaking to apply section 1834(a)(11)(B)(ii) of th e Act to add prosthetics and orthotics. We believe that our proposed current focus on DME ite ms is an appropriate way of balancing our goals of reducing fraud, waste, and abuse and li miting burden on beneficiaries and the supplier community. We also proposed to focus init ially on DME items for several reasons. We welcomed comments on limiting the associated burden of this proposed regulation by refining the number of items subject to a face-to-face encounter, while still meeting the requirements of the statute. The proposed list of Specified Covered Items cont ains items that meet at least one of the following four criteria: (1) items that currently require a written order prior to delivery per instructions in our Program Inte grity Manual; (2) items that cost more than $1,000; (3) items that we, based on our experience and recommendati ons from the Durable Medical Equipment Medicare Administrative Contractor s, believe are particularly susceptible to fraud, waste, and abuse; (4) items determined by CMS as vulnerabl e to fraud, waste and abuse based on reports of the HHS Office of Inspector General, Governme nt Accountability Office or other oversight791 entities. We are adding a criterion to remove any items where regulations explicitly state that a face-to-face encounter is not necessary. As desc ribed in the CY 2013 PFS proposed rule (77 FR 44796), we outlined each of these criteria. Our final list of Specified Covered Items is in Table 89 of this final rule with comment period. We further proposed to update this list of Specified Covered Items annually to add any new items that are described by a HCPC S code for the following types of DME :

● TENS unit

● Rollabout chair

● Manual Wheelchair accessories

● Oxygen and respiratory equipment

● Hospital beds and accessories

● Traction-cervical Note that the list does not include power mobility devices (PMDs), which are subject to already existing face-to-face requirements, as prev iously discussed. In addition, we proposed to add to the list any item of DME that in the fu ture appears on the DMEPOS Fee Schedule with a price ceiling at or greater than $1,000. Items not included in one of the proposed automatic pathways would be added to the list of Specified Covered Items through notice and comment rulemaking. Through updates in the Federal Register , we propose removing HCPCS codes from the list that are no longer covered by Medicare or that are discontinued HCPCS codes.

The DME list of Specified Covered Items are as follows, the original list was at 77 FR 44798: TABLE 89: DME List of Specified Covered Items HCPCS Code Description E0185 Gel or gel-like pressure mattress pad792

HCPCS Code Description E0188 Synthetic sheepskin pad E0189 Lamb's wool sheepskin pad E0194 Air fluidized bed E0197 Air pressure pad for mattr ess standard length and width E0198 Water pressure pad for mattr ess standard length and width E0199 Dry pressure pad for mattre ss standard length and width E0250 Hospital bed fixed height with any type of side rails, mattress E0251 Hospital bed fixed height with a ny type side rails without mattress E0255 Hospital bed variable height with any type side rails with mattress E0256 Hospital bed variable height with any type side rails without mattress
E0260 Hospital bed semi-electric (Head and foot adjustment) with any type side rails with mattress
E0261 Hospital bed semi-electric (head and foot adjustment) with any type side rails without mattress
E0265 Hospital bed total electric (head, f oot and height adjustments) with any type side rails with mattress
E0266 Hospital bed total electric (head, foot and height adjustments) with any type side rails without mattress E0290 Hospital bed fixed height without rails with mattress E0291 Hospital bed fixed height without rail without mattress E0292 Hospital bed variable height without rail without mattress E0293 Hospital bed variable height without rail with mattress
E0294 Hospital bed semi-electric (head a nd foot adjustment) without rail with mattress
E0295 Hospital bed semi-electric (head a nd foot adjustment) without rail without mattress
E0296 Hospital bed total electric (head, foot and height adjustments) without rail with mattress
E0297 Hospital bed total electric (head, foot and height adjustments) without rail without mattress E0300 Pediatric crib, hospital grade, fully enclosed
E0301 Hospital bed Heavy Duty extra wi de, with weight capacity 350-600 lbs with any type of rail, without mattress
E0302 Hospital bed Heavy Duty extra wide , with weight capacity greater than 600 lbs with any type of rail, without mattress
E0303 Hospital bed Heavy Duty extra wi de, with weight capacity 350-600 lbs with any type of rail, with mattress
E0304 Hospital bed Heavy Duty extra wide , with weight capacity greater than 600 lbs with any type of rail, with mattress
E0424 Stationary compressed gas Oxygen Sy stem rental; includes contents, regulator, nebulizer, cannula or mask and tubing
E0431 Portable gaseous oxygen system rent al includes portable container, regulator, flowmeter, humidifier, cannula or mask, and tubing E0433 Portable liquid oxygen system793

HCPCS Code Description

E0434 Portable liquid oxygen system, renta l; includes portable container, supply reservoir, humidifier, flowme ter, refill adaptor, content gauge, cannula or mask, and tubing

E0439 Stationary liquid oxygen system rent al, includes container, contents, regulator, flowmeter, humidifier, nebulizer, cannula or mask, and tubing E0441 Oxygen contents, gaseous (1 month supply) E0442 Oxygen contents, liq uid (1 month supply) E0443 Portable Oxygen contents, gas (1 month supply) E0444 Portable oxygen contents , liquid (1 month supply)
E0450 Volume control ventilator without pressure support used with invasive interface E0457 Chest shell E0459 Chest wrap E0460 Negative pressure ventilato r portable or stationary
E0461 Volume control ventilator wit hout pressure support node for a noninvasive interface E0462 Rocking bed with or without side rail
E0463 Pressure support ven tilator with volume control mode used for invasive surfaces
E0464 Pressure support vent with volume control mode used for noninvasive surfaces
E0470 Respiratory Assist Device, bi-lev el pressure capability, without backup rate used non- invasive interface
E0471 Respiratory Assist Device , bi-level pressure capability, with backup rate for a non-invasive interface
E0472 Respiratory Assist Device, bi-level pressure capability, with backup rate for invasi ve interface E0480 Percussor electric/ pneumatic home model
E0482 Cough stimulating device, alternat ing positive and negative airway pressure E0483 High Frequency chest wall oscill ation air pulse generator system E0484 Oscillatory positive expiratory device, non-electric E0570 Nebulizer with compressor E0575 Nebulizer, ultrasonic, large volume
E0580 Nebulizer, durable, glass or autoclav able plastic, bottle type for use with regulator or flowmeter E0585 Nebulizer with compressor & heater E0601 Continuous airway pressure device E0607 Home blood glucose monitor E0627 Seat lift mechanism incorporated lift-chair E0628 Separate Seat lift mechanism fo r patient owned furniture electric E0629 Separate seat lift mechanism fo r patient owned furniture non-electric794

HCPCS Code Description
E0636 Multi positional patient support system , with integrated lift, patient accessible controls E0650 Pneumatic compressor non-segmental home model
E0651 Pneumatic compressor segmental home model without calibrated gradient pressure
E0652 Pneumatic compressor segmental home model with calibrated gradient pressure
E0655 Non- segmental pneumatic appliance for use with pneumatic compressor on half arm
E0656 Non- segmental pneumatic appliance for use with pneumatic compressor on trunk
E0657 Non- segmental pneumatic appliance for use with pneumatic compressor chest
E0660 Non- segmental pneumatic appliance for use with pneumatic compressor on full leg
E0665 Non- segmental pneumatic appliance for use with pneumatic compressor on full arm
E0666 Non- segmental pneumatic appliance for use with pneumatic compressor on half leg
E0667 Segmental pneumatic appliance for use with pneumatic compressor on full-leg
E0668 Segmental pneumatic appliance for use with pneumatic compressor on full arm
E0669 Segmental pneumatic appliance for use with pneumatic compressor on half leg E0671 Segmental gradient pressure pneumatic appliance full leg E0672 Segmental gradient pressure pneumatic appliance full arm E0673 Segmental gradient pressure pneumatic appliance half leg
E0675 Pneumatic compression device, high pressure, rapid inflation/deflation cycle, for arterial insufficiency E0692 Ultraviolet light th erapy system panel treatment 4 foot panel E0693 Ultraviolet light th erapy system panel treatment 6 foot panel E0694 Ultraviolet multidirectional light therapy system in 6 foot cabinet
E0720 Transcutaneous electrical nerv e stimulation, two lead, local stimulation
E0730 Transcutaneous electrical nerve stim ulation, four or more leads, for multiple nerve stimulation E0731 Form fitting conductive garment for delivery of TENS or NMES
E0740 Incontinence treatment system, Pelvic floor stimulator, monitor, sensor, and/or trainer E0744 Neuromuscular stimulator for scoliosis E0745 Neuromuscular stimulator electric shock unit
E0747 Osteogenesis stimulator, electrical , non-invasive, other than spine application.795

HCPCS Code Description E0748 Osteogenesis stimulator, electrical , non-invasive, sp inal application E0749 Osteogenesis stimulator, elec trical, surgically implanted E0760 Osteogenesis stimulator, low in tensity ultrasound, non-invasive
E0762 Transcutaneous electrical joint stimulation system including all accessories
E0764 Functional neuromuscular stimulator, transcutaneous stimulations of muscles of ambulation with computer controls E0765 FDA approved nerve stimulator for treatment of nausea & vomiting E0782 Infusion pumps, implantable, Non-programmable E0783 Infusion pump, implantable, Programmable E0784 External ambulatory infusion pump E0786 Implantable programmable infusion pump, replacement E0840 Tract frame attach to he adboard, cervical traction
E0849 Traction equipment cervical, free-standing stand/frame, pneumatic, applying traction force to other than mandible E0850 Traction stand, free st anding, cervical traction E0855 Cervical traction equipment not requiring additional stand or frame E0856 Cervical traction device, cervical collar with inflatable air bladder E0958 Manual wheelchair accessor y, one-arm drive attachment E0959 Manual wheelchair accessory-adapter for Amputee E0960 Manual wheelchair accesso ry, shoulder harness/strap E0961 Manual wheelchair accessory wh eel lock brake extension handle E0966 Manual wheelchair acce ssory, headrest extension E0967 Manual wheelchair accessor y, hand rim with projections E0968 Commode seat, wheelchair E0969 Narrowing device wheelchair E0971 Manual wheelchair accessory anti-tipping device E0973 Manual wheelchair accessory, adju stable height, detachable armrest E0974 Manual wheelchair accessory anti-rollback device E0978 Manual wheelchair accessory positio ning belt/safety belt/ pelvic strap E0980 Manual wheelchair accessory safety vest E0981 Manual wheelchair accessory Seat upholstery, replacement only E0982 Manual wheelchair accessor y, back upholstery, replacement only
E0983 Manual wheelchair accessory pow er add on to convert manual wheelchair to motorized wheel chair, joystick control
E0984 Manual wheelchair accessory pow er add on to convert manual wheelchair to motorized wh eelchair, Tiller control E0985 Wheelchair accessory, seat lift mechanism E0986 Manual wheelchair accessory, push activated power assist E0990 Manual wheelchair acce ssory, elevating leg rest E0992 Manual wheelchair accessory, elev ating leg rest solid seat insert E0994 Arm rest796

HCPCS Code Description E1014 Reclining back, addition to pediatric size wheelchair E1015 Shock absorber for manual wheelchair E1020 Residual limb support system for wheelchair

E1028 Wheelchair accessory, manual swing aw ay, retractable or removable mounting hardware for joystick, other control interface or positioning accessory E1029 Wheelchair accessory, ventilator tray E1030 Wheelchair accessory, ventilator tray, gimbaled E1031 Rollabout chair, any and all type s with castors 5" or greater
E1035 Multi-positional patient transfer system with integrated seat operated by care giver E1036 Patient transfer system E1037 Transport chair, pediatric size E1038 Transport chair, adult size up to 300lb E1039 Transport chair, adult size heavy duty >300lb E1161 Manual Adult size wheelchai r includes tilt in space E1227 Special height arm for wheelchair E1228 Special back height for wheelchair
E1232 Wheelchair, pediatric size, tilt-in -space, folding, adjustable with seating system
E1233 Wheelchair, pediatric size, tilt-in-s pace, folding, adjustable without seating system
E1234 Wheelchair, pediatric size, tilt-in-s pace, folding, adjustable without seating system E1235 Wheelchair, pediatric size, rigi d, adjustable, with seating system E1236 Wheelchair, pediatric size, foldi ng, adjustable, with seating system E1237 Wheelchair, pediatric size, rigid, adjustable, without seating system
E1238 Wheelchair, pediatric size, fold ing, adjustable, without seating system E1296 Special sized wheelchair seat height E1297 Special sized wheelchai r seat depth by upholstery E1298 Special sized wheelchair seat depth and/or widt h by construction E1310 Whirlpool non-portable
E2502 Speech Generating Devices prerecord messages between 8 and 20 Minutes E2506 Speech Generating Devices prerecord messages over 40 minutes E2508 Speech Generating Devices message through spelling, manual type
E2510 Speech Generating Devices synthesized with multiple message methods E2227 Rigid pediatric wh eelchair ad justable K0001 Standard wheelchair K0002 Standard hemi (low seat) wheelchair K0003 Lightweight wheelchair797

HCPCS Code Description K0004 High strength ltwt wheelchair K0005 Ultra Lightweight wheelchair K0006 Heavy duty wheelchair K0007 Extra heavy duty wheelchair K0009 Other manual wheelchair/base K0606 AED garment with electronic analysis K0730 Controlled dose inhalation drug delivery system

c. Physician Payment We understand that there is a burde n associated with the requirem ent placed on the physician to document that a face-to-face encounter has occurr ed between a PA, a NP or a CNS, and the beneficiary. As discussed in section III.M.3 of this final ru le with comment period, we are establishing work and malpractice RVUs for HCPCS codes for G0454 by crosswalking to the work and malpractice RVUs for CPT code 99211 ((Level 1 office or other outpatient visit, established patient)

. With regard to practice expense R VUs, we are not in cluding any direct practice expense inputs for clinical labor, disposab le medical supplies, or equipment in the direct PE input database for this code; practice expens e RVUs will reflect resources for overhead costs only. The work, malpractice, and practice expe nse RVUs for HCPCS code G0454 are reflected in Addendum B of this CY 2013 PFS final rule with comment period www.cms.gov/physicianfeesched/ . A complete list of the interim final times assigned to HCPCS code G0454 is available on the CMS website at www.cms.gov/physicianfeesched/

. This code is to compensate a physician who documented that a PA, a NP, or a CNS practitioner has performed a face- to-face encounter for the list of Specified Covered Items. This G-code becomes effective when this provision of the regulation becomes effective. We believe that the existing Evaluation and Management (E&M) codes are sufficient for practitioners furnishing face-to-face encounters. This new G- code will be specifically designed and mapped798 only for a physician who completes the documentati on of the face-to-face encounter furnished by a PA, NP, or CNS. Only a physician who does not bill an associated E&M code for the beneficiary in question would be eligible for this G-code. If multiple written orders for covered items of DME originate from one visit, the phys ician can receive the G-code payment only once for documenting that the face-to-face encounter ha s occurred. The G-code would be mapped so that only eligible DME items would be covered. Upon request, we will need to see documentation of the face-to-face en counter in order to verify the appropriateness of the G-code payment. The following is a summary of the comment s we received regarding the physician payment proposal.
Comments : One commenter recommended against adoption of the new G-code, seeing little or no difference in the proposed documen tation requirement for face-to-face encounters conducted by a physician practice’s nonphysicians than other documentation requirements already imposed upon physicians. A few commenters stated that if CMS believes that physicians should be reimbursed for documenting f ace-to-face patient encounters conducted by nonphysicians in their employ, then the agency should more systematically determine all instances in which CMS-imposed administra tive burdens on physicians warrant Medicare reimbursement and seek Congressi onal (statutory) authority for such reimbursement policies. Response : In this final rule, we were only a ddressing additional work involved with documenting face-to-face encounters furnished by a PA, NP, or CNS for certain DME items. Other areas of CMS-imposed ad ministrative burden on physicians are beyond the scope of our regulation. The work, malpractice, and practic e expense RVUs for this code (HCPCS code G0454) are reflected in Addendu m B of this CY 2013 PFS final ru le with comment period at www.cms.gov/physicianfeesched/

.799

Comment : Several commenters supported the creation of a G-code, with a proposed payment of $15 to reimburse physicians for th e work involved in doc umenting face-to-face encounters with Physician Assistants or Nurse Pr actitioners. Commenters believed that it is important to properly reimburse physicians for ti me and effort. Some commenters request more information on how the dollar figure was arrived at and whether it is truly budget neutral. Response : The work, malpractice, and practice expense RVUs for this code (HCPCS code G0454) are reflected in A ddendum B of this CY 2013 PFS final rule with comment period

at www.cms.gov/physicianfeesched/ . This code is subject to budget neutrality under the physician fee schedule and has been accommodated fo r in the final rule. This code is cross walked to 99211.
Comment : Many commenters raised concerns ab out the statement that according to CMS, “only a physician who does not bill an E & M code for the beneficiary in question would be eligible for this G-code.” Commenters believed appropriate policy should allow for the billing of an E & M service that is clearly unrelated to the patient’s need fo r, and documentation of, DME authorization. Response : We will clarify in the final rule that this code is only for use when a physician documents the face-to-face encount er performed by a PA, NP, or CNS for certain DME items.
Comment : Several commenters believed that ther e should be an additional payment for the suppliers in addition to the additional paym ent for the practitioners conducting the face-toface encounter. Response : The only area available for additi onal payment is the physician documenting that a face-to-face encounter oc curred by a PA, NP, or CNS. We believe that the other documentation of the face-to-face en counter is within the normal sc ope of practice. The supplier receives the payment for the item and this face-to-face encounter is a condition of payment.800

Comment : This proposal fails to acknowledge the additional burden imposed on nurse practitioners and other providers who are required to coordinate with physicians to ensure the additional documentation of patie nt encounters in which the physic ian was not involved. If this unnecessary and burdensome documentation requir ement cannot be eliminated, then nurse practitioners and other nonphysician providers who are required to attempt to ensure that it is complied with should also be able to b ill for the proposed additional payment. Response : We must follow the statute which stat es that a physician must document that the face-to-face encounter occurred. In this instance, we are r ecognizing the additional physician work that may be involved thr ough the addition of a new G-code to compensate providers for this documentation requirement. We believe any necessary coordi nation with a physician following a face-to-face encounter with a bene ficiary is covered appropriately under the corresponding E/M code that would be billed by the PA, NP, or CNS for documenting the

occurrence. D. Elimination of the Requirement for Te rmination of Non-random Prepayment Complex Medical Review (§421.500 through §421.505) Medical review is the process performed by Medicare contractors to ensure that billed items or services are covered and are reason able and necessary as specified under section 1862(a)(1)(A) of the Act. We enter into contra ctual agreements with contractors to perform medical review functions. On December 8, 2003, the Congress enacted the MMA. Section 934 of the MMA amended section 1874A of the Act by adding a new subsection (h) – regarding random prepayment reviews and non-random pr epayment complex medical reviews and requiring us to establish termination dates for non-random prepayment complex medical reviews. Although section 934 of the MMA se t forth requirements for random prepayment review, our contractors do not perform random prepayment re view. However, our contractors do perform801 non-random prepayment complex medical review. On September 26, 2008, we published a final rule in the Federal Register (73 FR 55753) entitled, “Medicare Program; Termination of Non-Random Prepayment Complex Medical Review” that specified the criteria contractors would use for the termination of providers and suppliers from non-random prepayment complex medical review as required under the MMA. The final rule required contractors to termin ate the non-random prepayment complex medical review of a provider or supplie r no later than 1 year following the initiation of the complex medical review or when calcula tion of the error rate indicate s the provider or supplier has reduced its initial error rate by 70 percent or more. (For mo re detailed information, see the September 26, 2008 final rule (73 FR 55753)). On March 23, 2010, the Congress enacted the Patient Protecti on and Affordable Care Act (Pub. L. 111-148) and the Health Care and E ducation Reconciliati on Act of 2010 (HCERA) (Pub. L. 111-152) (together known as the Affordab le Care Act). Section 1302 of the HCERA, repealed section 1874A(h) of the Act. Section 1302 of the HCERA repealed secti on 1874A (h) of the Act, and therefore, removed the statutory basis for our regulation. Thus, we proposed to remove the regulatory provisions in 42 CFR part 421, subpart F, that re quire contractors to te rminate a provider or supplier from non-random prepayment complex me dical review no later than 1 year following the initiation of the medical review or when the provider or supplier has re duced its initial error rate by 70 percent or more. As a result of this proposal, contractors woul d not be required to terminate non-random prepayment medical revi ew by a prescribed time but would instead terminate each medical review when the provid er or supplier has met all Medicare billing requirements as evidenced by an acceptable erro r rate as determined by the contractor. The following is a summary of the public comments received and our responses:802

Comment : Commenters stated that the lack of st atutory authority is not a valid reason for withdrawing the regulation establishing requireme nts for termination of non-random prepayment complex review. CMS continues to possess the ge neral regulatory authority to maintain the regulation. Response : We believe that the repeal of section 1874A(h) of the Act reflects Congressional intent to require CMS to repeal the regulation CM S issued under that authority. Regardless of whether or not CMS could promul gate a different regulation establishing termination dates for non-random prepayment re view based on it general rulemaking authority, we nonetheless believe that the existing regulation must be removed. We also believe that sections 1815(a), 1833(e), 1862(a)(1)(A), and 1893 of the Act provide the st atutory authority to conduct non-random prepayment complex medical re view and we do not need to have another regulation in place for oversight of this work. We strive to balance our need to protect the integrity of the Medicare Trust Fund and our need to reduce improper payments against our interest in limiting provi der and supplier burden.
Comment : Some commenters expr essed concerns about the Agency’s proposal to remove all protections for pr actitioners undergoing non-random prepayment review and the discretion of each contractor to determine an acceptable error rate for eliminating non-random prepayment review. Other commenters expresse d concern that Medicare contractors will have too much power and authority. They suggested th at contractors do not or cannot articulate the thresholds that must be met to be taken off prepayment review. They recommended that CMS have a uniform, rational, and predictable process that permits providers/suppliers to be removed from non-random prepayment complex medical review. Response : We provide guidance to our contractors on the medical review process. The guidance is provided in Chapter 3 of th e Program Integrity Manual (Pub. 100-08). This guidance803 requires contractors to minimize potential futu re losses to the Medicare Trust Fund through targeted claims review and through progressive corre ctive actions that are ta ilored to the types of errors contractors identify rela ted to provider and supplier specif ic behavior. This requirement reflects CMS’ goal to limit the burden on provi ders and suppliers while aiming to achieve efficiencies in the Medicare Program.
Comment : Commenters stated that the prepay ment review process is burdensome and that reviews are often inconsistent and result in costly, unorganized compliance efforts for suppliers. Response : We believe that sections 1815(a), 1833(e) and 1862(A)(1)(a) of the Act provide authority for th e collection of documentation as may be necessary to determine the amounts due to a provider or supplier and to determine medical necessity of the services rendered. We strive to balance our need to protect the integrity of the Medicare Trust Fund and our need to reduce improper payments agai nst our interest in limiting provider burden.
Comment : Commenters suggested that CMS cons ider broader contractor reforms to assess contractors’ activities and evaluate the appr opriateness of their use of prepayment review. Commenters also suggested that CMS publish gu idelines on contractor requirements, public reports of contractor initia tives, have a public complaint and resolution process (or an independent entity to review and appeal by the provider or supplier for lifting the non-random prepayment complex medical review), and increa se methods of communications with suppliers and beneficiaries. Response : CMS has many activities underway that can be found at www.cms.hhs.gov website to monitor contractor oversight and compliance with na tional guidelines. We welcome all suggestions on how to improve the Medicare prepayment complex medical review process.
Comment : Commenters are concerned that th e entire prepayment medical review804 process will now be subject to agency guideline s set forth in manuals rather than formal regulation. Response : Section 1893 of the Act provides that contractors will perform medical review of claims to promote the integrity of the Medicare program. We do not believe another regulation is necessary a nd that the guidance to contractors on the medical review process is set forth in statute and manuals is adequate. The guidance is provided primarily in Chapter 1 and Chapter 3 of the Program Integrity manual (Pub. 100-08).
Comment : Commenters encouraged CMS to em ploy greater physician education and outreach to solve the issue of improper billi ng before placing physicians under prepayment review. Response : We provide physician education and outreach through various avenues including educational articles and Open Door Foru ms. Contractors are also instructed to provide education to physicians that are placed on prep ayment review and more details can be found on the contractor’s individual websites. After reviewing the public comments, we ar e finalizing these provi sions as proposed. We believe we need to do so in order to balan ce protection of the integrity of the Medicare Trust Fund and reduction of improper payments against limiting provider burden. E. Ambulance Coverage - Physic ian Certification Statement We proposed to revise §410.40(d)(2) by incor porating nearly the same provision found at §410.40(d)(3)(v) to clarify that a physician certification statemen t (PCS) does not, in and of itself, demonstrate that a non-emergency, schedul ed, repetitive ambulance service is medically necessary for Medicare coverage. The Medicare ambulance benefit at section 1861(s)(7) of the Act allows for coverage of an “ambulance service where the use of other methods of transportation is contraindicated by the individual’s condition, but. . . only to the extent provided805 in regulations.” In other words, the definition of the benefit its elf embodies the clinical medical necessity requirement that other forms of transportation must be contraindicated by a beneficiary’s condition. Secti on 410.40(d) interprets the medi cal necessity requirement. Notably, even aside from the requirements of section 1861(s)(7), secti on 1862(a)(1)(A) of the Act dictates that any service that is not medica lly necessary under the Ac t and regulations is not a covered benefit. Despite these statutory provisions and th e language of the pr esent regulation at §410.40(d)(2) that we believe already requires both medical necessity and a PCS, some courts have recently concluded that §410.40(d)(2) establis hes that a sufficiently detailed and timely order from a beneficiary’s physician, to the exclusion of any other medical necessity requirements, conclusively demonstrates medi cal necessity with re spect to nonemergency, scheduled, repetitive ambulance services. Absent explicit statutorily-based exceptions, we have consistently maintained that the Secretary is the final arbiter of whether a service is reasonable and necessary and qualifies for Medicare coverage. For example, in HCFA Ruling 93-1, we said “[i]t is HCFA’s ruling that no presumptive weight should be assigned to the treating physician’ s medical opinion in determining the medical necessity of inpatient hospital or SNF services under section 1862(a)(1) of the Act. A physician’s opinion will be eval uated in the context of the evidence in the complete administrative record. Even though a phys ician’s certification is required for payment, coverage decisions are not made based solely on this certification; they are made based on objective medical information about the patient’s condition and the services received. This information is available from the claims form and, when necessary, the medical record which includes the physician’s certification.” Medical necessity is not just an integral re quirement of Medicare’s ambulance benefit in806 particular, but, as noted above, section 1862(a)(1)(A) of the Act dict ates that services must be reasonable and necessary to qualify for any Medi care coverage. Numerous U.S. Circuit Courts of Appeal have held that PCSs or certificates of medical necessity do not, in and of themselves, conclusively demonstrate medical necessity. Th e same applies in the context of non-emergency, scheduled, repetitive ambulance services—the PCS is not, in and of itself, the sole determinant of medical necessity, and, as we discuss be low, we believe the existing regulation at §410.40(d)(2) already demonstrates that. To er ase any doubt, however, we proposed a revision to §410.40(d)(2) to explicitly clarify this principle. Since being finalized in the February 27, 2002 Federal Register (67 FR 9100, 9132), §410.40(d)(2) has stated that “Medicare covers medically necessary non-emergency, scheduled, repetitive ambulance services if the ambulance provi der or supplier, before furnishing the service to the beneficiary, obtains a written order from the beneficiary’s atte nding physician certifying that the medical necessity requirements of paragr aph (d)(1) of this sect ion are met.” Although a physician certifies with respect to medical necessity, the Secretary is the final arbiter of whether a service is medically necessary for Medicare cove rage. As demonstrated by the inclusion of the phrase “medically necessary,” and by various other clarifying points, we ma de clear that a PCS, while necessary, does not on its own conclusive ly demonstrate the medical necessity of nonemergency, scheduled, repetitive ambulance services. The preamble to the February 27, 2002 final rule (Medicare Program; Fee Schedule for Payment of Ambulance Services and Revisions to the Physician Certific ation Requirements for Coverage of Nonemergency Ambulance Services (67 FR 9100)) and the 1999 final rule with comment (FRC) (Medicare Program; Coverage of Ambulance Services and Vehicle and Staff Requirements (64 FR 3637)) support this interpretation. For example, in describing comments rega rding medical necessity and physician807
certification in the 1999 FRC, we said: “[t]wo ambulance suppliers commented that physicians are unaware of the coverage requirements for ambulance services and that their decisions to request ambulance services may be based on ‘f amily preference or the inability to safely transport the beneficiary by other means rather than on the medical necessity requirement imposed by Medicare.’” We responded that sec tion 1861(s)(7) of the Act allows coverage only under certain limited circumstances, and suggested that “[t]o facilitate awar eness of the Medicare rules as they relate to the ambulance service be nefit, ambulance suppliers may need to educate the physician (or the physician’s staff members) when making arrangements for the ambulance transportation of a beneficiary. ” We continued that “[s]upplie rs may wish to furnish an explanation of applicable medical necessity re quirements, as well as requirements for physician certification, and to explain th at the certification statement s hould indicate that the ambulance services being requested by th e attending physician are medically necessary.” (76 FR 3637, 3641) Since we recognize the significant progra m vulnerability – that the physicians writing PCSs might not be fully cognizant of the Me dicare ambulance benefit’s medical necessity requirements (and encourage suppliers to help re medy that by educating physicians), it would not be reasonable to vest exclusively in the PCS the authority to demonstrate an ambulance transport’s medical necessity. We made a similar point in response to a separate comment: “It is always the responsibility of the ambulance s upplier to furnish complete and accurate documentation to demonstrate that the ambulan ce service being furnished meets the medical necessity criteria.” (76 FR 3637, 3639). In the section of the February 27, 2002 final rule preamble describing the PCS requirements, we said: “[i]n all cases, the appr opriate documentation must be kept on file and, upon request, presented to the carrier or intermediary. It is important to not e that the presence of the signed physician certification statement does not necessarily demonstrate that the transport808 was medically necessary. The ambulance supplier must meet all coverage criteria for payment to be made.” (67 FR 9100, 9111) Although we incorporat ed that passage into the final rule only at §410.40(d)(3)(v), we intended, and we believe our inte nt was clear from the preamble narrative, that the principle apply equally to all nonemergency ambulance transports. The OIG report entitled “Medicare Paymen ts for Ambulance Transports” (OEI-05-02- 00590) (January 2006) also supports our position. Based on its anal ysis of a sample of calendar year 2002 claims, the OIG reported that “27 percent of ambulance transports to or from dialysis facilities did not meet Medicare’s coverage criteria.” The OIG added “the ongoing and repetitive nature of dialysis treatment makes transports to and from such treatmen t vulnerable to abuse. Although the condition of some patie nts warrants repetitive, sche duled ambulance transports for dialysis treatment, many dial ysis transports do not meet coverage criteria.” The OIG recommended that we instruct our contractors to implement prep ayment edits with respect to dialysis transports and have them re quest wide-ranging documents when conducting postpayment medical review. The fact that we agreed with the OIG’s recommendations demonstrated our belief that the PCS was not the sole determinant of medical necessity. Likewise, the fact that the OIG mentioned our ambulance coverage regul ations, including the PCS requirement, but did not recommend altering or clarifying the regulations with respect to medical necessity demonstrated that we were of like mind; that, while a physician certifies with respect to medical necessity, the Secretary is the final arbiter of whether a service is medically
necessary. Accordingly, we proposed to revise §410.40( d)(2) to add nearly the same provision presently found at §410.40(d)(3)(v), except for the reference to a “s igned return receipt” that does not pertain to non-emergenc y, scheduled, repetitive ambulance services. We proposed to accomplish this by redesignating the current la nguage as §410.40(d)(2)(i), and adding the809 clarifying language to a new §410.40(d)(2)(ii). The proposed §410.40( d)(2)(ii) clarifies that a signed physician certification statem ent does not, in and of itself, demonstrate that an ambulance transport was reasonable and necessary. Rather, for all ambulance services, providers, and suppliers must retain on file all appropriate documentation a nd present such documentation upon request to a Medicare contract or. A CMS contractor may use such documentation to assess, among other things, whether the service satisfied Medicare’s medical necessity, eligibility, coverage, benefit category, or a ny other criteria necessary for Me dicare payment to be made. For example, the patient’s condition must be such that other means of transportation would be contraindicated, and the services provided must be reasonable and necessary for the diagnosis or treatment of illness or injury. We also proposed to fix the typographical error “fro,” which should be “from”, in the existing § 410.40(c)(3)(ii). The following is a summary of the comme nts received on the physician certification statement proposal and our responses:
Comment : Several commenters stated that it appears that CMS believes that the provider, not the physician signing the PCS, is re sponsible for the content of the PCS and that CMS does not intend to hold the physician signin g the PCS responsible for the content of the PCS. Commenters also questioned whether the proposed rule would mean that the ambulance provider/supplier cannot rely on a properly physic ian-signed PCS as a tool in the process of proving medical necessity. The commenters disagreed with CMS’ statement that ‘no presumptive weight’ should be assigned to the treating physician ’s medical opinion in determining medical necessity, recommending inst ead that CMS adopt a presumption that a repetitive transport is medically necessary when the ambulance provider/supplier has a valid physician-signed PCS. The commenters stated that CMS is not only requiring ambulance810 providers/suppliers to police themse lves, but physicians as well. As a result, it is the ambulance provider/supplier who must bear the sole risk of not being reimbursed for a claim that CMS deems does not meet medical necessity. Response : Ambulance providers are not respon sible for the content of a properly prepared PCS, but, to the extent ambulance provi ders wish to be reimbursed by Medicare, they are responsible for ensuring they provide ambulance tr ansports to eligible be neficiaries that meet Medicare’s ambulance coverage and medical nece ssity criteria. We be lieve the PCS is one safeguard to help ensure that the medical neces sity criteria of Medicare’s ambulance transport benefit is met, but it is not the only safeguard. Indeed, especially since a PCS may be written as much as 2 months before the service is provi ded, we must be mindful of other safeguards including the totality of the medical record and the physical pr esentation of the beneficiary when the service is rendered. Furthermore, the ambulan ce provider/supplier is not obligated to provide a service in the absence of a properly signed PCS. There is no expectation by CMS that ambulance providers/suppliers police physician practice.
Comment : Several commenters stated that while the proposed rule focuses on revisions to the PCS regulations in the case of repetitive transports, they strongly urged CMS to modify the requirements for non-repetitive, non-emergenc y transports and to address the burden of the PCS in that context by eliminating it. Curre nt PCS requirements, they asserted, impose unreasonable burdens on providers/suppliers that far outweigh any benefit of the PCS to the Medicare Program. Response : We disagree because, as we note repeat edly in these responses, we believe the PCS is a valuable safeguard and an important tool that helps ensure that we pay only for claims that meet all Medicare coverage and payment crit eria, and will not be making any changes in this final rule to the requirements for non- repetitive, non-emergency transports.811

Comment : Several commenters stated that CM S gives ambulance providers/suppliers no assurance that Medicare w ill cover the service, even if they have an attending physician’s order for the ambulance service. They are concer ned that ambulance providers/suppliers have to decide whether they are going to disregard an order from a beneficiar y’s attending physician simply because the patient’s insurer might not give any weight to that order. Response : By statute and regula tion, Medicare may only pay for medically necessary ambulance transports and as with any service, we have the discretion to review a claim to ensure it satisfies all Medicare coverage and payment criteria. To sati sfy coverage criteria, medical necessity must be supported by adeq uate medical record documentation.
Comment : Several commenters stated that the DOJ strategy for pursuing ambulance providers/suppliers should not ha ve any bearing on CMS policy for coverage of claims, that the requirement for ambulance provide rs/suppliers to obtain a PCS s hould be based on the need for medical judgment on the level of care requ ired by the patient, and that ambulance providers/suppliers should be ab le to rely on the PCS for such. These commenters noted that if the PCS requirement is for some other non-medical purpose such as DOJ policy, or is simply a CMS requirement for an exercise in futility, the PCS requirement s hould be struck in its entirety. Response : As noted in the responses above and by virtue of its statute and regulations, Medicare only pays for medically necessary ambulance transports. The PCS is an important tool that we use as a safeguard to help ensure medi cal necessity, but as we mention above, it is not the only tool, nor, in and of itsel f, is it a conclusive determin ant of medical necessity.
Comment : Several commenters stated that CMS should also exempt from PCS requirements the two following types of transpor ts: ground intercepts with air ambulance; and hospital-to-hospital transports. These commente rs noted that these modifications to the PCS812 requirement would apply for non-emergency, no n-repetitive transports, thus limiting its application. Response : Not only do we disagree since we believe the PCS is a valuable safeguard, but we note that we did not propose to relax or exempt PCS require ments in any situation.
Comment : Several commenters stated that the pr oposed rule ignores th e fact that when ambulance providers/suppliers are contacted to tran sport a patient for a non-emergency transport, they are often given little information about the patient’s condition. Ambulance providers/suppliers must rely on information from the attending phys ician who has intimate knowledge about the patient’s ambulatory state. Response : While we appreciate that obtai ning information may sometimes be challenging, this does not alter ou r responsibility to only pay Medi care claims that satisfy all Medicare coverage and payment criteria. As we noted in the preamble to the proposed rule and in an earlier response, it may be incumbent upon ambulance providers/suppliers to help educate physicians or their staff members regarding the rules pertaining to Medicare’s ambulance service benefit and to request additional information at the time ambulance transport is requested to gauge whether the transport meets Medica re’s coverage and payment criteria.
Comment : Several commenters believed that a PCS from an attending physician obtained before the ambulance service should carry the same weight as physician orders that prescribe other Medicare-covered services. When a physician signs the PCS, these commenters noted, he or she is providing the same support that auditors rely upon to determine medical necessity. Response : Although we do not disagree that a physician PCS carri es the same weight as physician orders that prescribe ot her Medicare-covered services, we note that we similarly audit813 physician orders for medical necessity based on supporting medical record documentation as those orders, like the PCS in the ambulance context, in and of themselves are not determinative.
Comment : Several commenters stated that since CMS alread y requires ambulance providers/suppliers to maintain documentation that demonstrates medical necessity for all ambulance transports, they believe that CM S should likewise rely on documentation from ambulance providers/suppliers for the types of non-emergency transports for which a PCS is currently required, and therefore, requested that CMS eliminate the PCS requirement for all nonemergency ambulance transports and all schedule d, repetitive ambulance transports completely. Response : We do rely on the medical documenta tion for ambulance transports, but, as described both in the preamble and in other resp onses, believe the PCS is an additional important safeguard that helps ensure medical necessity.
Comment : Several commenters expressed that obtaining a PCS remains challenging for ambulance providers/suppliers because, among othe r reasons, physicians may refuse to sign a PCS or because facilities and physicians sometim es confuse the PCS requirements for repetitive and non-repetitive transport patients, requiri ng the ambulance provider/supplier to spend substantial time justifying why they are seeking the PCS and what is required. Response : While we understand the challenges provi ders/suppliers may face in obtaining a PCS, as noted above our primary responsibil ity is ensuring we pa y only properly payable Medicare claims and we believe that the PCS is a necessary tool in help ing to determine medical necessity.
Comment : Several commenters believed that CMS does not intend to hold physicians accountable for their signed certific ations about medical necessity. Despite the fact that a signed PCS must be obtained from a physician, these commenters noted that ambulance814 providers/suppliers bear the sole burden of de termining whether Medicare’s medical necessity criteria have been met. Response : The fact that ambulance provi ders/suppliers, just like other providers/suppliers, may face some risk of non-payment when submitting claims for Medicare payment cannot alter our primary responsibility to only play clai ms that meet all Medicare coverage and payment criteria. Although, as we have explained, we cannot rely exclusively upon the PCS as a determinant of medical necessity, the PCS is an important tool to help establish medical necessity for the ambulance transport of a Medicare beneficiary.
Comment : Several commenters recommended that CMS allow additional facility personnel, such as LPNs, social workers, or case managers to be author ized signatories for the PCS requirement. Response : We are limiting the changes in this fi nal rule to those out lined in the proposed rule. We did not propose to revise our policy re garding who may sign a PCS. As a result, we take no position at this time on whether LPNs or other additi onal facility personnel should be authorized signatories. After reviewing the public comments, we are finalizing the revisions to §410.40(c)(3)(ii) and §410.40(d)(2) as proposed. F. Physician Compare Website 1. Background and Statutory Authority Section 10331(a)(1) of the Affordable Care Act requires th at, by no later than January 1, 2011, we develop a Physician Compare Internet website with information on physicians enrolled in the Medicare program un der section 1866(j) of the Act, as well as information on other eligible professionals who participate in the Physician Quality Reporting System (PQRS) under section 1848 of the Act.815 CMS launched the first phase of Physician Compare ( http://www.medicare.gov/find-adoctor/provider-search.aspx ) on December 30, 2010. The initia l phase included the posting of the names of eligible professionals that satisfactorily submitted quality data for the 2009 PQRS, consistent with section 1848(m)(5)(G) of the Act. Since the initial la unch of the website, we have continued to build and improve Physicia n Compare. Currently users can search by selecting a location and specialty for physicians or other healthcare professionals. Search results provide basic information about approved Medicare providers, such as primary and secondary specialties, practice locations, group practice affiliations, hos pital affiliations, Medicare Assignment, education, languages spoken, and gende r. As required by section 1848(m)(5)(G) of the Act, we have added the names of those elig ible professionals who ar e successful electronic prescribers under the Medicare Electronic Pres cribing (eRx) Incentive Program. As such, physician and other healthcare professional profile pages indicate if prof essionals satisfactorily participated in the PQRS and/or are successful electronic prescribers under the eRx Incentive Program based on the most recent data ava ilable for these two quality initiatives. 2. Public Reporting of Physician Performance Section 10331(a)(2) of the Affordable Care Act also requires that, no later than January 1, 2013, and for reporting periods th at begin no earlier than January 1, 2012, we implement a plan for making publicly availabl e through Physician Compare, information on physician performance that provides comparable qua lity and patient experience measures. This plan is outlined below.
Comment: We received several comments requesting that CMS clarify its plans with respect to making PQRS data publicly availa ble through Physician Compare no later than January 1, 2013. Response: We appreciate the commenters’ intere st in public reporting on Physician816 Compare. Please note that CMS has met the Af fordable Care Act requirements to implement a plan prior to January 1, 2013 for making phys ician performance information available on Physician Compare, and intends to continue to outline elements of that plan through rulemaking. To the extent that scientifically sound meas ures are developed and are available, we are required to include, to the ex tent practicable, the following types of measures for public reporting:

● Measures collected under the PQRS.

● An assessment of patient health outc omes and functional status of patients.

● An assessment of the c ontinuity and coordination of care and care transitions, including episodes of care and risk-adjusted resource use.

● An assessment of efficiency.

● An assessment of patient experience and patient, caregiver, and family engagement.

● An assessment of the safety, e ffectiveness, and timeliness of care.

● Other information as determined appropriate by the Secretary. As required under section 10331(b) of the Affordable Care Act, in developing and implementing the plan, we must include, to th e extent practicable, the following:

● Processes to ensure that data made public are statistically valid, reliable, and accurate, including risk adjustment mech anisms used by the Secretary.

● Processes for physicians and eligible professionals whose information is being publicly reported to have a reasonable opportunit y, as determined by the Secretary, to review their results before posti ng to Physician Compare.

● Processes to ensure th e data published on Physician Compare provides a robust and accurate portrayal of a physician’s performance.

● Data that reflects the care provided to all patients seen by p hysicians, under both the817 Medicare program and, to the extent applicable, other payers, to the extent such information would provide a more accurate portrayal of physician performance.

● Processes to ensure appropriate attribut ion of care when multiple physicians and other providers are involved in th e care of the patient.

● Processes to ensure timely statistical pe rformance feedback is provided to physicians concerning the data published on Physician Compare.

● Implementation of computer and data infr astructure and systems used to support valid, reliable, and accurate re porting activities. Section 10331(d) of the Affordable Care Act requires us to consider input from multi-stakeholder groups in selecting quality measur es for Physician Compare, which we seek to accomplish through rulemaking and focus groups . In developing the plan for making information on physician performance publicly av ailable through Physician Compare, section 10331(e) of the Affordable Care Act requires the Secretary, as the Secretary deems appropriate, to consider the plan to transition to value-base d purchasing for physicians and other practitioners that was developed under section 131(d) of the Medicare Improvements for Patients and Providers Act of 2008. We are required, under section 10331(f) of the Affordable Care Act, to submit a report to the Congress by January 1, 2015, on Physician Comp are development, and include information on the efforts and plans to collect and publish data on physician quality and efficiency and on patient experience of care in support of value-based purchasing and consumer choice. Section 10331(g) of the Affordable Care Act provides that a ny time before that date, we may continue to expand the information made available on Physician Compare. We believe section 10331 of the Affordable Care Act supports our overarching goals of providing consumers with quality of care information to make in formed decisions about their818 healthcare, while encouraging clinicians to impr ove on the quality of care they provide to their patients. In accordance with se ction 10331 of the Affordable Care Act, we intend to utilize Physician Compare to publicly report physician performance results. In implementing our plan to publicly repor t physician performan ce, we will use data reported under the existing PQRS as an initial step for maki ng physician “measure performance” information public on Physician Compare. By “measure performance” in relation to the PQRS, we mean the percent of times that a particular clinical quality acti on was reported as being performed, or a particular outcome was attained, for the applicable persons to whom a measure applies as described in the denom inator for the measure. For m easures requiring risk adjustment, “measure performance” refers to the risk adjusted percentage of times a particular outcome was attained. We previously finalized a decision to make public on Physician Compare the performance rates on the quality measures th at group practices submit under the 2012 PQRS group practice reporting option (G PRO) (76 FR 73417). Therefore, we are targeting to post performance information collected through th e GPRO web interface for group practices participating in the 2012 PQRS GPRO on Physician Compare in 2013 or early 2014. Specifically, we will make public performance information for measures included in the 2012 PQRS GPRO that meet the minimum sample size, and that prove to be statistically valid and reliable. As we previously established, if th e minimum threshold is not met for a particular measure, or the measure is otherwise deemed not to be suitable for public reporting, the group’s performance rate for that measure will be suppr essed and not publicly reported. We previously established a minimum threshold of 25 patie nts for reporting performance information on Physician Compare (76 FR 73418). Although we c onsidered keeping the threshold for reporting performance data on Physician Compare at 25 pa tients, we proposed to change the minimum819 patient sample size, from 25 patients to 20 patien ts, beginning with data collected for services furnished in 2013 (77 FR 44803). The following is summary of the comments we received regarding the new minimum patient sample size proposal:
Comment : We received comments related to the reduction in patient threshold for public reporting. Most commenters oppose d the reduction, stating that th e lower threshold may be less accurate and statistically valid. One commenter pointed to literature supporting the previous threshold of 25, and suggested that CMS mainta in this threshold, though the commenter did not expressly state which literature th ey were referencing, and one s uggested a patient size of 30. We received comments stating that this reduced sample size was insufficient to apply across all measures, and that the sample size should be de termined based on the measure to which it is applied. One commenter requested further detail on what it would mean for a measure to be suitable for public reporting. Seve ral comments were supportive of the proposal stating that this may increase participation. Response : We appreciate the commenters’ feed back regarding reducing the patient sample size for public reporting from 25 patients to 20 patients. We are committed to reporting quality of care data that is statistically valid, re liable, and accurate, and will only post data that meet this standard of reliability regardless of threshold, and regardless of measure type. Should we find a measure meeting the minimum threshold to be invalid or unreliable for any reason, the measure will not be reported. We appreciate the comment that this reducti on may increase participation; however we note that this proposal only relates to Physic ian Compare. While the decreased threshold may increase participation for other quality reporti ng programs, we do not believe it will have an impact on Physician Compare.820 We believe this threshold of 20 patients to be sufficient to protect patient privacy for reporting on the site, and should thus be appl ied to every measure reported on Physician Compare. Currently, this is the reliability th reshold being finalized for both the Value-Based Modifier (VBM) and the proposed PQRS criteria fo r reporting measure groups. As we work to align quality initiatives and minimize reporting burden on physicians and other healthcare professionals, we will finalize our proposal to reduce the reporting threshold from 25 to 20 patients. In the Shared Savings Program final rule (76 FR 67948), we finali zed Accountable Care Organization (ACO) public reporting provisions in th e interest of promoti ng greater transparency regarding the ACOs participati ng in the program. We finalized requirements for ACOs to publicly report certain data, as well as data that we would publicly report. Because ACO providers/suppliers that are e ligible professionals are consid ered to be group practices for purposes of qualifying for a PQRS incentive under the Shared Sa vings Program, we indicated that performance on quality measures reported by AC Os at the ACO TIN level, on behalf of their ACO providers/suppliers who are eligible professi onals, using the GPRO web interface would be reported on Physician Compare in the same way as for the groups that report under the PQRS. In April 2012, we added functionality to Phys ician Compare allowing users to search for group practices in preparation for the additi on of 2012 PQRS GPRO data. A full website redesign is slated for early 2013 to further prepare the site for the introducti on of quality data and ACO information. With each enhancement, we wo rk to improve the usability and functionality of the site, providing consumers with more t ools to help them make informed healthcare decisions. In CY 2012, we intend to enhance the accuracy of “administrative” information displayed on the eligible professional’s profile page, and to add additional data. By administrative data, we821 are referring to information about eligible pr ofessionals that is pulled from the Provider Enrollment, Chain, and Ownership System (PECOS ) and other readily ava ilable external data sources. Specifically, we intend to add whether a physician or other heal th care professional is accepting new Medicare patients, boa rd certification information, and to improve the foreign language and hospital affiliation data. We also intend to include the names of those eligible professionals who participated in the Medicare EHR Incentive Program, as authorized by section 1848(o)(3)(D) of the Act, and the names of t hose eligible professionals who satisfactorily participated under the PQRS GPRO for 2011. We will continue to update the names of those eligible professionals and group practices who satisfactorily participated under the PQRS, and those who are successful electr onic prescribers under the eRx Incentive Program based on the most recent program year data available.
Comment : We received one comment in support of the inclusion of eRx and PQRS Incentive Program Data or Administrative data on the site, and one comment requesting that participation information for PQRS be limited to those who satisfactorily report this information. Response : We appreciate the commenter's feedb ack and support for including eRx and PQRS Incentive Program participation data on Phys ician Compare. We intend to continue to post the names of those eligible professionals and group practices who satis factorily participated under the PQRS, and those who are successful el ectronic prescribers under the eRx Incentive Program on the website as we are required to re port this information publicly, and Physician Compare offers an excellent venue for making this information available to consumers.
Comment : We received comments regarding the posting of Medicare EHR Incentive Program participation and Meaningful Use part icipation information on Physician Compare. One commenter requested that CMS post the names of all those who participate in the Medicare EHR Incentive Program, not just those who did so successfully. One commenter requested that822 we add a note to distinguish what stage of Mean ingful Use the eligible professional is taking part. Response : We intend to post the names of those eligible professionals who successfully participated in the Medicare EHR Incentive Progr am on Physician Compare, when feasible. We will further evaluate the suggesti on regarding stages of Meaningful Use, but at this time CMS does not intend to distinguish betw een stages of participation. In support of the HHS-wide Mill ion Hearts Initiative, we pr oposed to post the names of the eligible professionals who report the PQRS Cardiovascular Preven tion measures group (77 FR 44803). This is consistent with the require ments under section 10331 of the Affordable Care Act to provide information about physicians and other eligible profession als who participate in the PQRS. The following is a summary of the comments r eceived regarding the proposal to post the names of eligible professionals who report the PQRS Cardiovascular Prevention measures group in support of the Milli on Hearts Initiative:
Comment: Commenters generally supported our proposal. Some commenters pointed out that the PQRS Cardiovascular Prevention measur es group may not apply to all professionals or all specialties, and were therefor e in support of the proposal only if those professionals who did not report on the measures group were not negatively represented for their lack of participation. One commenter requested that the mechanism of data submission also be reported on the site. Response: At this time, we are ta rgeting posting the names of eligible professionals who satisfactorily report PQRS Cardiovascular Prev ention measures group in support of the Million Hearts Initiative in 2014 for the 2013 reporting period. As with all participation data of this nature on Physician Compare, if a professional is participating in this program by satisfactorily reporting on the PQRS Cardiovasc ular Prevention measures group, an indicator will be noted on823 their profile page; if a professional is not sa tisfactorily reporting on th is measures group, no indicator will be included. We believe this approach se rves to acknowledge those who participate without negative reflection on those who do not. While we appreciate the comment that data submission mechanism also be reported on the site, it is not t echnically feasible to report that information at this time. 3. Future Development of Physician Compare Consistent with Affordable Care Act requir ements, it is our intent to phase in an expansion of Physician Compare over the next several years by incorporating quality measures from a variety of sources, as technically feasib le. For our next phase , we proposed to make public on Physician Compare, performance rates on the quality measures that group practices submit through the GPRO web interface under the 2013 PQRS GPRO and the Medicare Shared Savings Program (77 FR 44803). We indicated that we antici pated the 2013 PQRS GPRO web interface measures data would be posted no s ooner than 2014. These data would include measure performance rates for measures incl uded in the 2013 PQRS GP RO web interface that met the proposed minimum sample size of 20 patien ts, and that proved to be statistically valid and reliable. When technically feasible, and targeted fo r posting on the site in 2014, we proposed to publicly report composite measures that re flect group performance across several related measures (77 FR 44803). As an initial step we intend to develop diseas e module level composite scores for PQRS GPRO measures. Under the Medicare Shared Savings Program, ACOs are required to report on composite measures for Di abetes Mellitus (DM) and Coronary Artery Disease (CAD) (76 FR 67891). Accordingly, in an effort to align the PQRS GPRO measures with the GPRO measures under the Shared Sa vings Program, we proposed to add composite measures for DM and CAD into the PQRS starti ng in reporting year 2013. We also indicated we824 would consider future development of composites for the remaining disease level modules within the GPRO web interface. As more data are adde d to Physician Compare ove r time, we stated we would consider adding additional disease level composites across measure types as technically feasible and statistically valid. The following is a summary of the comments received regarding our proposal to post performance rates on the quality measures that group practices submit through the GPRO web interface under the 2013 PQRS GP RO and the Medicare Shared Savings Program, and to report composite measures at the diseas e module level for 2013 GPRO data:
Comment: One commenter supported our propo sal to post PQRS GPRO and ACO performance rates as it was limited to measures reported through the GP RO web interface, and suggested CMS not expand reporting to data coll ected via other reporting mechanisms at this time. Another commenter expressed support of our proposal to post composite measures at the disease module level, but requested that CMS postpone the posting of these composites until physicians and groups have time to review their perf ormance as it pertains to individual elements of the composite. Response: We are dedicated to providing quality of care data on Physician Compare as soon as feasible so that healthcare consumers have access to information to help them make informed healthcare decisions. We are finali zing our proposal to post performance rates on the quality measures that group practices s ubmit through the GPRO web interface under the 2013 PQRS GPRO and the Medicare Shared Savings Program. In an effort to align PQRS GPRO measures with the GPRO measures under the Sh ared Savings Program, we are finalizing our proposal to generate composite measures for DM and CAD based on measur es reported through the GPRO web interface for groups participating in program y ear 2013 PQRS GPRO and ACOs participating in the Shared Savings Program. This requirement regarding posting of ACO data is825 finalized at §425.308. We target posting these data in 2014 for the 2013 reporting period, as technically feasible, as we believe these data are valuable to consumers in evaluating group practices and ACOs. We will provide a 30-day prev iew period prior to publication of quality data on Physician Compare so that ACOs and group practices can view their data as it will appear on Physician Compare before it is publicly reported. Consistent with the requirement under section 10331(a)(2) of the Affordable Care Act to implement a plan to make comparable information on patient experience of care measures publicly available, we proposed to post patien t experience survey-based measures from the Clinician and Group Consumer As sessment of Healthcare Provide rs and Systems (CG-CAHPS) (77 FR 44804). As discussed in section G.6.c. of this final rule with comment period, we proposed to collect the following patient expe rience of care measures for group practices participating in the PQRS GPRO (77 FR 44964):

• CAHPS: Getting Timely Care, Appointments, and Information

• CAHPS: How Well Your Doctors Communicate

• CAHPS: Patients’ Rating of Doctor

• CAHPS: Access to Specialists

• CAHPS: Health Promotion and Education These measures capture patients’ experiences wi th clinicians and thei r staff, and patients’ perception of care. We proposed, no earli er than 2014, to publicly report 2013 patient experience data for all group practices particip ating in the 2013 PQRS GPRO, not limited to those groups participating via the GPRO web interface, on Physician Compare. At least for 2013, we noted that we intended to administer and collect patien t experience survey data on a sample of the group practices’ beneficiaries. As we intend to administer and collect the data for these surveys, we indicated that we did not anticipate any notabl e burden on the groups.826 For ACOs participating in the Shared Savi ngs Program, consistent with the PQRS proposal to publicly report pa tient experience measures on Physician Compare starting in 2013, we proposed to publicly report pa tient experience data in additi on to the measure data reported through the GPRO web interface ( 77 FR 44804). Specifically, the pa tient experience measures that would be reported for ACOs include th e CAHPS measures in the Patient/Caregiver Experience domain finalized in the Shared Savings Program final rule (76 FR 67889):

• CAHPS: Getting Timely Care, Appointments, and Information

• CAHPS: How Well Your Doctors Communicate

• CAHPS: Patients’ Rating of Doctor

• CAHPS: Access to Specialists

• CAHPS: Health Promotion and Education

• CAHPS: Shared Decision Making For patient experience data re ported under either the PQ RS GPRO or the Medicare Shared Savings Program, we also considered an alternative option of providing confidential feedback to group practices and ACOs using 2013 patient experience da ta before publicly reporting patient experience data on Physician Compare (77 FR 44804). In lieu of publicly reporting the patient experience da ta relating to 2013 PQRS GPRO and ACOs participating in the Shared Savings Program, we considered usin g the 2013 results as a baseline to be shared confidentially with the group practices and AC Os, during which time the group practices and ACOs would have the opportunity to review their data, and implement changes to improve patient experience scores. Under this altern ative option, program year 2014 patient experience data would be the first to be publicly reporte d on Physician Compare, and we would publicly report 2014 patient experience data for ACOs and group practices participating in the 2014 PQRS GPRO on Physician Compare no earlier th an 2015. We invited public comment on our827 proposal to begin publicly reporti ng patient experience data for program year 2013, and also the alternative option of delaying public reporting of patient experience of care data on Physician Compare until program year 2014 in order to give group practices and ACOs the opportunity to make changes to the processes used in their prac tices based on the review of their data from program year 2013 (77 FR 44804). The following is a summary of the comments we received regarding our proposal to publicly report patie nt experience data:
Comment : Many commenters supported the alternat e proposal to post 2014 data in 2015, and to use 2013 data as confid ential feedback for providers to review their results. Most commenters believed this would give groups a chan ce to improve their results before they are publically reported, and some commenters sugge sted that groups have the opportunity to resurvey patients prior to the posting of results. Response : We appreciate the commenters’ feed back regarding the posting of patient experience data for 2014 in 2015 and using the results of patient experience data collected for program year 2013 as a confidential reporting period so that physicians can review their data and improve on their performance before the start of public reporting. We are de dicated to providing patient experience data on Physician Compare as soon as feasible so th at healthcare consumers can have access to this important information to help them make informed decisions. After considering the public comments, our final decisi on is to provide all ACOs and group practices an opportunity to see their patient experience da ta in reports provided by the data collection vendor before it is published. A 30-day preview period prior to publication will allow ACOs and group practices to see their data as it will appear on P hysician Compare before it is reported. This 30-day period is in line with the preview period provided for other public reporting programs such as Hospital Compare.828 Understanding the strong desire from consumers for these data, and given our commitment to public reporting, we are finalizing our proposal to target the reporting of patient experience data, collected no earlier than 2013, on Physician Compare in 2014, if technically feasible, for groups of one hundred or more elig ible professionals reporting via the GPRO web interface, including ACOs partic ipating in the Shared Savings Program. The requirement regarding posting of ACO data is finalized at §425.308. We believe that by limiting this posting requirement to group practices and ACOs par ticipating via the GPRO web interface, and by allowing group practices and ACOs to preview th eir data during a 30-day preview period, we are able to address the concerns of the provider community while making this data available to healthcare consumers and meeting the mandates set forth by the Affordable Care Act. Due to patient privacy and confidentiality, we will not implement the suggestion that groups have the opportunity to resurvey patients prior to the pos ting of results.
Comment: Some commenters expre ssed concern over the cost of implementing a patient experience survey, and others questioned whether th e surveys were adequately tailored to certain types of groups and settings, such as emergency departments, stating that the survey used should be validated for a variety of settings. Some of these commen ters suggested that different surveys, such as S-CAHPS for surgical sett ings should be used based on setting. One commenter also suggested that the entire CAHP S survey should be used as opposed to only using certain domains. Response: We are dedicated to accurate, valid, a nd reliable public reporting on Physician Compare and are aware that each group practice is unique in size and scope. We have closely evaluated the available data co llection mechanisms, and are confident that CG-CAHPS is a welltested collection mechanism with strong support from the healthcare community, and that it provides the best opportunity to collect useful and accurate data for the largest number of group829 practices. We will use only those survey domains th at are applicable to group practices or ACOs respectively, and believe that th ese domains have been well teste d, and will therefore provide the best data for the larg est number of groups. We are dedicated to supporting group practices in the reporti ng of these important data. Thus, we are finalizing a policy under which CMS w ill administer the patient experience of care survey for calendar year 2013 and 2014 for all group practices of 100 or more eligible professionals that sign up for the PQRS GPRO web interface. Similarly, as discussed in the Shared Savings Program Final Rule, CMS will fund and administer the CAHPS survey for ACOs participating in the Shared Savings Program in 2013 (76 FR 67875). As we continue to improve administrative and provider level data , we proposed posting the names of those physicians who earned a PQRS Maintenance of Certification Program Incentive as data becomes available, and targeted for 2014 (77 FR 44804). The following is a summary of the comments we received related to posting the names of physicians who earned a PQRS Maintenan ce of Certification Program Incentive:
Comment: Many commenters were supportive so long as there were no negative reflections on those who did not receive the in centive; however, one commenter did not believe this information was relevant to Physician Compare. Response: We are finalizing our pr oposal to include the names of eligible professionals who earned an incentive in the PQRS Maintenance of Certification Program Incentive as data are available, and targeted for 2014. To address concer ns regarding negative impact, as with all data of this nature currently on Phys ician Compare, if an eligible professional is participating in the program, an indicator will be noted on their prof ile page; if a professiona l is not participating, no indicator or negative indication will be included. We believe this approach serves to acknowledge those who earned a PQRS Maintenance of Certification Program Incentive without830 reflecting negatively on those who did not. We also believe that this information will be helpful to healthcare consumers as they work to make in formed healthcare decisions and is thus relevant to Physician Compare.
Comment : We received one comment requesting that ABMS Maintenance of Certification status be postedon the site, and one suggesting that information about ABMS Maintenance of Certification also be posted. Response : We appreciate the commenter's f eedback regarding including ABMS Maintenance of Certification data on Physician Compare. At this time, we are targeting to post the names of eligible professionals who earned a PQRS Maintenance of Certification Program incentive as data are available, and targeted for 2014. We do not currently have plans to also include the ABMS MOC information, but w ill consider this for future rulemaking. We considered allowing measures that have been developed and collected by approved and vetted specialty societies to be reported on Physician Compar e, as deemed appropriate, and as they are found to be scientifically sound and statistically valid (77 FR 44804). We proposed including additional claims-based process, outcome and resource use measures on Physician Compare, and noted that we intend to align measure selection for P hysician Compare with measures selected for the Value Based Modifier (VBM) (section III.K). We received several comments related to re porting measures devel oped and collected by specialty societies. The following is a summary of the comments we received:
Comment: Many commenters believe this was a good way to identify measures that are most appropriate for certain specialties, and to reduce the reporting burden on those specialties as the measures are already being collected, and their data are already available. Several commenters offered to assist CMS in gatheri ng these data. A few commenters requested clarification on what measures would be posted, how CMS would vet these measures.831
Response: We appreciate the commenters’ feedb ack regarding reporting of measures developed by specialty societies on Physicia n Compare. We understand the importance of publicly reporting measures that are most appr opriate for all specialti es, and believe working with specialty societies to identify quality meas ure data that are alrea dy collected and available reduces the reporting burden on these specialties while providing accurate, reliable, and valid data on the site. This approach also provide s an opportunity to e xpand public reporting to specialties and types of physicians not currently represented. We intend to work with specialty societies to identify the most a ppropriate data sources and mechan ism for inclusion on Physician Compare. We will work to ensure that any specialty society data included on Physician Compare is approved, vetted, scientifically s ound, and statistically reliable. As with PQRS measures and other measures posted on Physician Compare, any measures under consideration will be subjected to the Measures Application Partnershi p (MAP) pre-rulemaking process prior to being considered for posting on the site. Please note that such measures will be addressed in future rulemaking. We received comments related to our proposed alignment of Physician Compare with the VBM. The following is a summary of the comments we received:
Comment : One commenter did not support our proposal to ali gn with PQRS or the VBM as they believed this data may be overwhelming to healthcare consumers. The commenter went on to say that Physician Compare should distinguis h itself as a site committed to communicating validated and meaningful information, and not try to align with these programs. Response : We appreciate the commenters’ feed back regarding the proposal to align public reporting on Physician Compare with elemen ts of PQRS and the VBM. We are committed to working toward reporting measures that are a ccurate and complete. Pl ease note that not all832 measures collected will be posted on the si te, and only those measures that are deemed appropriate for public reporting and useful to co nsumers will be posted. We believe alignment with PQRS and the VBM on Physician Compare provides significant oppor tunities as we move toward a payment model related to quality and cost efficiencies. Aligning quality initiatives also provides an opportunity for public ally reporting more quality data while also minimizing the reporting burden on eligible professionals. We w ill continue to align our public reporting goals with these programs.
Comment : One commenter questioned how CMS is able to report performance data on Physician Compare within one year, but points ou t the technical infeasibility of calculating performance-based payments within that same time frame. Response : We appreciate the commenter's fee dback regarding a timeline for public reporting on Physician Compare in relation to the timeline for calculating performance-based payments. We are working on a phased approa ch to public reporting across a number of data sources and are looking to do so in a way th at does not increase reporting burden, allows accurate reporting, and supports the agency’s mi ssion and goals. For these reasons, we are working to align the measures reported on Physician Compare with other CMS quality initiatives, such as PQRS and VBM as technicall y feasible. Please note that not all measures included in these other initiativ es will be publicly reported on th e site, and that the programs have distinct timelines. Performance-based paym ents require additional calculation beyond that which we proposed to publicly report. While Physician Co mpare has a plan to report performance data as soon as technically feasible , we will not report that data before it has been accurately calculated, and has proved to be statistically valid and reliable. We proposed to include group level ambul atory care sensitive condition admission measures of potentially preventable hospita lizations developed by the HHS Agency for833 Healthcare Research and Quality (AHRQ) that meet the proposed minimum sample size of 20 patients, and that prove to be statistically valid and reliable (measure details are available at http://www.qualitymeasures.a hrq.gov/content.aspx?id=27275 ) (77 FR 44804). We proposed reporting these measures on Physician Compare no earlier than 2015 for those group practices composed of 2 - 99 eligible professionals part icipating in the proposed 2014 PQRS GPRO, and for ACOs. We received comments related to our propos al to post group level ambulatory care sensitive condition admission measures of potenti ally preventable hospitalizations developed by AHRQ. The following is a summary of the comments we received:
Comment : Most commenters opposed the posting of these measures, and one commenter stated that they strongly oppos ed the addition of these measures. One commenter requested clarification as to what testing and validation had b een done around these measures. Response : We are committed to only including quality of care measures on Physician Compare that are properly vetted an d tested, as well as statistically valid and reliable. We have decided to allow other programs within CMS to wo rk with these measures, gather the data, and provide feedback to the groups prior to posting on Physician Compare. We will not finalize our proposal to post group level ambulatory care sensitive condition admission measures of potentially preventable hospitalizations at this time. Instead, we will consider the input we received as we further evaluate the inclusi on of such measures on Physician Compare, and address this issue in future rulemaking. We also proposed to publicly report performance rates on quality measures included in the 2015 PQRS and VBM for individual eligible professionals (77 FR 44804). We indicated, however, that further details on what measures would be included in the 2015 reporting period will be addressed in future rulemaking. We al so proposed that public reporting of 2015 PQRS834 and administrative claims-based quality measures for individuals would occur no earlier than
2016. We received several comments related to the posting of individual-level measures on Physician Compare. The following is a su mmary of the comments we received:
Comment : Some commenters support ed our proposal, and one requested that this information be made available as soon as t echnically feasible stating the information was valuable to consumer decision making. One comm enter requested that CMS consider including data that is reported through a va riety of reporting mechan isms such as claims and registries to ensure all reporting individuals would be re presented regardless of reporting mechanism. Response : We agree that individual-level m easure data is important in helping consumers make informed healthcare decisions, a nd agree that this information should be posted on the site as soon as technically feasible. We will move up this plan and target posting individual-level measure data in 2015 using 2014 data if technically feasible. Please note that further discussion of this topic, and the measures to be included will be addressed in future rulemaking.
Comment : One commenter opposed the posting of individual-level measure data stating this data may be overwhelming to consumers. The commenter went on to caution that measures posted on Physician Compare should be selected based on how well they resonate with consumers. Another commenter expressed concerns regarding the different reporting mechanisms available in PQRS , and how measures reported th rough the different mechanisms would be represented. Response : We appreciate the commenter’s c oncerns around the posting of these measures. We are committed to including only the most accurate, statistically reliable and valid quality of care measure data on Physician Compar e when the data are pub licly reported. Any835

data found to be invalid or inaccurate for a ny reason will not be publicly reported. We will ensure that these data are coll ected and presented appropriatel y, regardless of the mechanism through which they are collected, and that they accu rately reflect performance. Measures to be posted on the site will be selected based on a variet y of criteria including consumer interest, and will be subject to consumer testing. Please note that further discussion of this topic, and the measures to be included will be addressed in future rulemaking. For all measures publicly reported on Physicia n Compare, we proposed to post a standard of care, such as those endorse d by the National Quality Forum ( 77 FR 44804). Such information would serve as a standard for consumers to m easure individual provider, and group level data. We received comments related to our proposal to post a standard of care on Physician Compare. The following is a summary of the comments we received:
Comment : One commenter supported our proposa l to post a standard such as those endorsed by the NQF. Some comm enters sought clarification ar ound the standard to be used, and expressed concerns that an NQF standard ma y be limiting to certain specialties, stating that NQF standards are heavily focused on primary care. Commenters also suggested consumer testing if such as standard is to be posted to insure the information is understandable to

consumers. Response : We appreciate the commenters’ feedback regarding posting a standard of care on Physician Compare. We are currently cons idering including an NQF standard for those measures reported on Physician Compare where a standard of care is e ndorsed, available, and applicable. We are declining to finalize our proposal at this ti me and are only seeking additional comment. We will address this issue in future rulemaking. We received several comments not direct ly related to our proposals which are summarized below.836

Comment : The majority of commenters was co ncerned about the accuracy of data currently on Physician Compare, and urged CMS to c onsider this feedback in its plans for future development. Commenters stated that data on Physician Compare did not meet certain standards of accuracy, and one called for a cessation of the site until concerns could be addressed. Some commenters expressed frustration about the difficulty they e xperienced in getting their information updated or corrected, and some requ ested a way to update their information on the site. Some commenters requested that data be up dated in a timely fashion to ensure it is up-todate and accurate. One commenter expressed co ncerns related to data collection mechanisms and comparability on Physician Compare. Response : We are committed to including accurate and up-to-date information on Physician Compare and continue to work to ma ke improvements to the information presented. The current primary data source for Physician Compare is PECOS. In order for a physician, other healthcare professional, or group practice’s information to appear on Physician Compare, their enrollment record in PECO S must be current and in ‘‘a pproved’’ status, a valid physical location or address must be identified, and the profe ssional must have an NPI. It is critical that data in PECOS be accurate and up-to-date to ensure the data on Physician Compare are also accurate and up-to-date. CMS is evaluating other options for physician, healthcare professionals and group practices to update thei r information, and is looking at ot her available data sources to validate PECOS data to further improve accuracy as we continue to improve the data presented on Physician Compare. We are equally committed to including only th e most accurate, statistically reliable and valid quality of care measure da ta on Physician Compare when t hose data are publicly reported. We are committed to ensuring that these data are comparable and presented appropriately regardless of the mechanism through which they ar e collected, and that they accurately reflect837 performance. We will ensure these data are update d in a timely fashion as technically feasible, and will provide a 30-day preview period for physic ians and group practices to view their data prior to it being posted on the site.
Comment : We received comments requesting a disc laimer be placed on the site for the purpose of explaining why measures may not apply to certain gr oups, and that the absence of data on a particular measure does not imply poor performance or poor quality. Response : We agree with the commenters th at disclaimers and other forms of explanatory language are necessary to help inform healthcare consumers and other users of the site. Regarding the request fo r a disclaimer, or clarifica tion explaining the absence of participation or measure data, we are evalua ting disclaimer language for use on Physician Compare when data are published on the site, an d will take this feedback into consideration.
Comment : We received several comments cautioning that too much data on the site could cause confusion for consumer s and other users of the site. Response : We appreciate the commenters’ feedb ack, and understand their concerns. As required under section 10331(b) of the Affordable Care Act, in developing and implementing the plan to include performance data on Physician Compare, we must include, to the extent practicable, processes to ensure that the posted data are statisti cally valid, reliable, and accurate, including risk adjustment mechanisms used by the Secretary, as well as processes to ensure appropriate attribution of care when multiple prov iders are involved in the care of the patient. We understand that this information is co mplex, and are committed to providing data on Physician Compare that are useful to beneficiaries in assisting them to make informed healthcare decisions, while being accurate, valid, reliable, and complete. We will closely evaluate all quality measures under consideration for public reporting on the website to ensure they are presented in a way that is help ful to beneficiaries and, through consumer testing and stakeholder838
outreach, will work to ensure that the number of measures and da ta sources presented is done in such a way that the information is valuable to consumers.
Comment: We received several comments requesting that a section of Physician Compare be dedicated to hospita l-based physicians, or that Phys ician Compare link to Hospital Compare for certain hospital-based physicians so users may view data on hospital-based physician through a variet y of perspectives. Response : We appreciate the commenters’ feedback regarding customizing a section of Physician Compare for hospital-based physicians. Physician Compare is tasked with providing consumers with useful information about Medica re physicians and other healthcare professionals who provide services in a variety of specialties and care settings. At this time, it is not feasible to customize the website for specific physician groups , but we will consider this feedback as we continue to evaluate if such cu stomization is beneficial to cons umers and potentially feasible in future development. We will continue to ev aluate a link between Physician Compare and Hospital Compare as appropriate.
Comment : We received comments requesting that CMS include other healthcare professionals on Physician Compare and not limit the site to physicians. Response : We appreciate the commenter's feedb ack. Currently the site does feature information on physicians and other healthcare prof essionals as required by the Affordable Care
Act.
Comment: We received one comment stating that CMS should consider a distillation of quality data into a reporting system such as star ratings for physicians and group practices. Response: We appreciate the commenter’s sugges tion, and agree that a reporting system such as star ratings can be helpful to users in consuming these data. We will continue to evaluate star ratings and other methods of displaying m easure data based on the measures selected for839 posting on the site.
Comment : We received one comment requesting that additional education, residency and administrative information for physicians and ot her healthcare professionals be posted on the site. Response : We appreciate the feedback regarding the inclusion of education, and other administrative information on Physician Compare. At this time, Physician Compare includes some educational and residency information. We are working to include Board Certification information on the site as feasible, and will conti nue to evaluate additional information and data sources that can provide beneficial information for consumers as they are available in the future. All posting of this a dditional information will be a ddressed in future rulemaking. We are committed to making Physician Comp are a constructive tool for Medicare beneficiaries, successfully meeting the Affordab le Care Act mandate, a nd in doing so, providing consumers with information needed to make info rmed healthcare decisions. We have developed a plan, and started to implement that plan w ith a phased approach to adding physician quality data to Physician Compare. We believe this st aged approach to public reporting of physician quality information allows consumers access to in formation that is currently available while we continue to develop the infrastructure neces sary to support additional types of data and information on physicians’ quality measure performance. Implementation of subsequent phases of the plan will need to be de veloped and addressed in future notice and comment rulemaking, as needed.

G. Physician Payment, Efficiency, and Qua lity Improvements – Physician Quality Reporting System840

There are several healthcar e quality improvement program s that affect physician payments under the Medicare PFS. The National Quality Strategy establ ishes three aims for quality improvement across the nation: better hea lth, better healthcare, and lower costs. This strategy, the first of its kind, outlines a nationa l vision for quality improvement and creates an opportunity for programs to align quality measur ement and incentives ac ross the continuum of care. We believe that this alignment is especi ally critical for program s involving physicians. The proposals that follow facilitate the alignmen t of programs, reporting systems, and quality measures to make this vision a reality. We be lieve that alignment of CMS quality improvement programs will decrease the burden of participation on physicians and allow them to spend more time and resources caring for beneficiaries. Fu rthermore, as the leaders of care teams and the healthcare systems, physicians and other clinicia ns serve beneficiaries both as frontline and system-wide change agents to improve quality. However, we believe that to improve quality, quality measurement and reporting is an important component. It is our intent that the following requirements will improve alignment of physician-focused quality improvement programs, decrease the burden of successful participation on physicians, increase engagement of physicians in quality improvement, and ultimately lead to higher quality care for beneficiaries.

This section contains the requirements for the Physician Quality Reporting System (PQRS). The PQRS, as set forth in section 1848(a), (k), and (m) of the Act, is a quality reporting program that provides incentive payments and pa yment adjustments to eligible professionals based on whether or not they satisfactorily report data on quality measures for covered professional services furnished during a specified reporting period. We note that, in developing these requirements, it was our goal to align program requirements between these quality reporting programs, such as the eRx Incenti ve Program, EHR Incentive Program, Medicare Shared Savings Program, and value-based paymen t modifier, wherever possible. We believe841 that alignment of these quality reporting program s will lead to greater ov erall participation in these programs, as well as minimize the repo rting burden on eligible professionals. Please note that, during the comment period following the proposed rule, we received comments that were not related to our specifi c proposals for PQRS in the CY 2013 Medicare PFS proposed rule. While we appreciate the co mmenters' feedback and intend to use these comments to better develop PQRS, these comments wi ll not be specifically addressed in this CY 2013 Medicare PFS final rule, as they are beyond the scope of this rule. However, we will take these comments into consideration when deve loping policies and program requirements for future years. The regulation governing the PQRS is loca ted at §414.90. The program requirements for years 2007-2012 of the PQRS that were previously established, as well as information on the PQRS, including related laws and estab lished requirements, are available at https://www.cms.gov/Medicare/Qual ity-Initiatives-Patient-AssessmentInstruments/PQRS/index.html . Please also note that in this final rule with comment period, we are making technical changes to §414.90 to ai d in the readability of the regulation. 1. Methods of Participation There are two ways an eligible professional can participate in th e PQRS: (1) as an individual or (2) as part of a group practice participating in the PQRS group practice reporting option (GPRO). a. Participation as an Individual Eligible Professional – Traditional Reporting Mechanisms As defined at §414.90(b), the term ‘‘eligible professional’’ means any of the following: (1) a physician; (2) a practitione r described in section 1842(b)(18 )(C) of the Act; (3) a physical or occupational therapist or a qualified sp eech-language pathologist; or (4) a qualified audiologist. For more information on which prof essionals are eligible to participate in the842
PQRS, we refer readers to the ‘‘L ist of Eligible Professionals’’ download located in the ‘‘How to Get Started” section of the PQRS CMS website at http://www.cms.gov/Medicare/QualityInitiatives-Patient-Assessment-Instru ments/PQRS/How_To_Get_Started.html . There is no requirement to self-nominate to participate in the PQRS as an individual eligible professional for the incentive or to use claims, regist ry, or EHR reporting mechanisms. b. Participation as a Group Practice in the GPRO (1) Definition of Group Practice We proposed to modify §414.90(b) to defi ne group practice as “a single Tax Identification Number (TIN) with 2 or more eligible professionals, as identified by their individual National Provider (N PI), who have reassigned their Medicare billing rights to the TIN” (77 FR 44806). We proposed to change the number of eligible professionals comprising a PQRS group practice from 25 or more to 2 or more to allow all groups of smaller sizes to participate in the GPRO. We believe that expa nding the scope of group practices eligible to participate under the program will lead to greate r program participation. To participate in the GPRO, a group practice would be required to meet this proposed definition at all times during the reporting period for th e program year in which the group pract ice is selected to participate in the GPRO. We solicited public comments on the proposed definition of group practice. The following is a summary of the comments we received regarding this proposal.
Comment : Several commenters supported our propos al to change the definition of group practice to include groups of 2-24 eligible prof essionals because the commenters believed that the proposal would allow more group practi ces to participate in the GPRO. Response : We appreciate the commenters' feedb ack and are finalizi ng our proposal to modify §414.90(b) to define a grou p practice as "a single Tax Id entification Number (TIN) with843 2 or more eligible professionals, as identifie d by their individual Na tional Provider Identifier (NPI), who have reassigned thei r billing rights to the TIN." We hope that expanding the GPRO to allow small group practices of 2-24 eligible professionals to participate in the GPRO will encourage greater participation in PQRS.
Comment : Although some commenters supported our proposal to change the definition of group practice to include gr oups of 2-24 eligible professi onals, the commenters urged CMS not to make additional changes to this definition in the near fu ture. The commenters note that CMS has changed the group practice definition ev ery year since it was included as a PQRS reporting option in 2010, leading to confusion for many eligib le professionals and group practices participating in PQRS. Response : Each year, we have sought to improve the GPRO based on stakeholder feedback and data we receive from past partic ipation. The GPRO has also changed due to a desire to align this GPRO with other quality re porting programs, such as the Medicare Shared Savings Program. Nonetheless, we unders tand the complexity and confusion caused by changing this definition each year and will keep that in mind in the future when proposals are presented.
Comment : One commenter opposed our proposal to change the definition of group practice to include groups of 2-24 eligible professionals until the implications of such a change are more clearly understood. Furthermore, the commenter believes the proposal confuses the alignment of the PQRS program with the VBM that proposes to incorporate groups of 25 or more eligible professionals. Response : We understand the commenters’ concer n and acknowledge that our proposal to define a group practice as groups of 2 or more eligible professionals does not align perfectly with our proposal to apply the Value-based Paym ent Modifier to physician groups of 25 or more844 eligible professionals ( see section K). However, we note that, although our goal is overall alignment with the Value-based Payment Modifier , there may be instances, such as this one, where the two programs may not completely ali gn. For example, although we are expanding the definition of group practice to define a group pr actice as a group of 2 or more eligible professionals, the Value-based Payment Modifier, as described in section K, will only apply to physician group practices of 100 or more in 2013. Therefore, smaller groups of 2-99 eligible professionals will remain unaffected by the final policies we are finalizing under the Value-based Payment Modifier in 2013. When determining program requirements, we considered factors other than alignment with the Value-based Payment Modifier. For example, aside from alignment, we adopted policies that we believe will increase overall pa rticipation in PQRS, as well as increase the likelihood that eligible professi onals will meet the criteria fo r satisfactory reporting for the 2013 and 2014 PQRS incentives and 2015 and 2016 PQRS payment adjustments. We believe that expanding the definition of group practices to groups of 2 or more eligible professionals will help to achieve these goals, because we are pr oviding group practices with additional ways to participate in PQRS.
Comment : Some commenters disagreed with our pr oposal to define a gr oup practice as "a single Tax Identification Number (TIN) with 2 or more eligible professi onals, as identified by their individual National Provider Identifier (NPI), who have reassigned their billing rights to the TIN" rather than limiting the definition of group practice to physicians. The commenters believe this classification is misleading, as a solo physic ian with a nurse practitioner or other eligible professional working in the practice would be cl assified as a group prac tice under this definition. Response : We thank the commenter for expressing their concern regarding the definition of a group practice. We note that section 1848(m)(3)(c) of the Act, which governs group845 practice reporting under the PQ RS, explicitly identifies “elig ible professionals in a group practice” (and further affords us th e authority to define group pract ice). So we do not believe the definition of group practice under the PQRS is lim ited to physicians. We also note that the PQRS applies to “eligible prof essionals,” which is defined unde r section 1848(k)(3)(B) of the Act to include physicians and other types of practit ioners that are specifically identified. Also, from a policy perspective, we believe it is im portant to measure the care given by healthcare professionals other than physicians. Therefore, we are finalizing the PQRS definition of a group practice to include all elig ible professionals, not just physician group practices. (2) Election Requirement for Group Practices Selected to Partic ipate in the GPRO Please note that, for group practices part icipating in PQRS through other Medicare programs (such as but limited to those group pr actices participating as Accountable Care Organizations (ACOs) under the Medicare Shared Sa vings Program), certain provisions in this section may not apply. For information on how to participate in PQRS through other Medicare programs, please refer to the requirements for those respective programs. GPRO Self-Nomination Statement . We established the proce ss for group practices to be selected to participate in the GPRO in the CY 2012 PFS final rule with comment period (76 FR 73316). However, this section contains additional processe s for a group practice’s selfnomination statement that we proposed for group pr actices selected to pa rticipate in the GPRO for 2013 and beyond. For the requirement that gr oup practices wishing to participate in the GPRO submit a self-nomination statement (76 FR 73316), for 2012, we accepted these selfnomination statements via a letter accompanied by an electronic file submitted in a format specified by CMS because it was not operationally f easible to receive self -nomination statements via the web at that time. In the CY 2012 Medi care PFS final rule with comment period, we noted that we anticipated that CMS would have th e ability to collect self-nomination statements846 via the web for the 2013 PQRS Therefore, we proposed that, for 2013 and beyond, a group practice must submit its self-nomination statement via the web. We noted that this web-base d functionality is still being developed by CMS. Therefore, in the event this web-based functionality w ould not be available in time to accept selfnomination statements for the 2013 PQRS, we proposed that, in lieu of submitting selfnomination statements via the web, a group prac tice would be required to submit its selfnomination statement via a letter accompanied by an electronic file submitted in a format specified by CMS (such as a Microsoft excel file ) (77 FR 44807). We proposed that this selfnomination statement would be mailed to the following address: Cent ers for Medicare & Medicaid Services, Center of Clinical Standards and Quality, Quality Measurement and Health Assessment Group, 7500 Security Boulevard, Mail Stop S3-02-01, Baltimore, MD 21244-1850. If mailing the self-nomination statement, we w ould require that this self-nomination statement be received by no later than 5 PM Eastern Standa rd Time on January 31 of the year in which the group practice wishes to part icipate in the GPRO.We invited public comment on the proposed method for submitting a GPRO selfnomination statement. The following is a summ ary of the comments we received on this proposal.
Comment : One commenter was concerned about the use and efficiency of a web portal for accepting GPRO self-nomination statements due to a potentially incr eased number of selfnomination statements that will be accepted through the web and potential delays in the web portal. Response : We understand the commenter's concerns regarding the poten tial for delays in the web portal. However, we believe that accep ting self-nomination statements via the web will be the most efficient way for group practices to complete and CMS to accept and process GPRO847
self-nomination statements. Therefore, we ar e finalizing our proposal to accept GPRO selfnomination statements via the web for 2013 and be yond. We also anticipat e an increase in the number of GPRO self-nomination statements rece ived due to our expansion of the GPRO as well as use of the PQRS GPRO for the application of the Value-based Payment Modifier. Therefore we are working to further devel op the web portal to account for in creased traffic. Please note that group practices submitting self-nomination st atements via the web will be required to comply with CMS’ security and system require ments to submit a self-nomination statement via the web. However, should a group practice wishi ng to self-nominate encounter issues doing so, the group practice may contact the QualityNet He lp Desk for assistance with submitting a selfnomination statement. As for our proposed contingency plan for accepting self-nomination statements via mail in the event the web-based functionality was not be available in time to accept self-nomination statements for the 2013 PQRS, or in the even t we experience issues with accepting selfnomination statements via the web, we are also finalizing that pr oposal. While we expect that we will have the web system operational, we believe it is appropriate to have an alternative submission process available as a back-up. Th erefore, if the web-ba sed functionality is unavailable in time to accept se lf-nomination statements for the 2013 PQRS, or in the event we experience issues with accepting self-nomination statements via the web, in lieu of submitting self-nomination statements via the web, a group pract ice is required to su bmit its self-nomination statement via a letter accompanied by an electronic file submitted in a format specified by CMS (such as a Microsoft excel file), and a mailed to the following address: Centers for Medicare & Medicaid Services, Center of Clinical Standards and Quality, Quality Measurement and Health Assessment Group, 7500 Security Boulevard, Mail Stop S3-02-01, Baltimore, MD 21244-1850. Although we proposed to require that this se lf-nomination statement be received by no848

later than 5 PM Eastern Standard Time on Janua ry 31 of the year in which the group practice wishes to participate in the GPRO, we believe it is appropriate to prov ide group practices with additional time to submit this information a nd self-nominate under the PQRS. Additional time for submissions may also address concerns raised by commenters about the potential for increased number of self-nomination statements a nd efficiency of the web portal with regard to avoiding delays. As we discuss in greater deta il below in response to co mments we received, we also believe it would be helpful to afford group pr actices additional time with regard to selecting its reporting mechanism, which group practices must include in the self-nomination statement. Therefore, we are finalizing a deadline of October 15 of the year in which the group practice wishes to participate in the GPRO. We believe this is an appropriate amount of time for group practices under the PQRS. Moreover, we note that this deadline aligns with the final policies we are adopting for the value-based payment modifi er. For those group practices for whom the value-based payment modifier will apply, this extended deadline will provide groups with additional time to make decisions with rega rd to participation under the PQRS. GPRO Selection of Reporting Mechanisms. In the CY 2012 Medicare PFS final rule with comment period, we established what info rmation is required to be included in a group practice’s self-nomination statement (76 FR 73316). In 2012, the group practice only had one reporting mechanism available on which to repor t data on PQRS quality measures: the GPRO web interface. However, beginning 2013, we propos ed to allow group practic es to report data on quality measures using the claims, registry, a nd EHR-based reporting mechanisms for the PQRS incentive and payment adjustment (77 FR 44870) . Additionally, we proposed to allow group practices to use the proposed administrative claims reporting option. We proposed that a group practice wishing to participate in the GPRO for a program year would be re quired to indicate the reporting mechanism the group practice intends to use for the applicable reporting period in its849
self-nomination statement. Furthermore, once a group practice is selected to participate in the GPRO and indicates which reporting mechanism th e group practice would use, we proposed that the group practice would not be al lowed to change its selection. Therefore, under this proposal, the reporting mechanis m the group practice indicates it w ould use in its self-nomination statement for the applicable reporting period would be the only reporting mechanism under which CMS would analyze the group practice to determine whether the group practice has met the criteria for satisfactory repor ting for the PQRS incentive and/ or payment adjustment. We acknowledged that this proposal would depart from the way we an alyze an individual eligible professional, as CMS analyzes an individual eligible professional (who is permitted to use multiple reporting mechanisms during a repor ting period) under every reporting method the eligible professional uses. Unfortunately, due to the complexity of analyzing group practices under the GPRO, such as having to associate multiple NPIs under a single TIN, it is not technically feasible for us to allow group pract ices using the GPRO to use multiple reporting mechanisms or switch reporting mechan isms during the reporting period. We solicited public comment on our proposal to lock-in a group practice’s reporting mechanism choice at the time self-nomination. Th e following is summary of the comments we received regarding this proposal.
Comment : One commenter stated that group practi ces should be allowed to change the reporting mechanisms through the calendar year in case a more advantageous reporting option is available later in the year. For example, a group practice may want to change its reporting mechanism during a given reporting pe riod after the list of qualified registries becomes available. Response : We agree that group practices should be provided with some flexibility to change their reporting mechanisms. We it is onl y fair to provide group practices with a window to switch their initially chosen reporting mechanisms, as indivi dual eligible professionals are850 allowed to switch reporting mechanisms throughout the year. Therefore, we are allowing group practices to switch their chosen reporting mechan ism until October 15 of the applicable reporting period. We believe this window provides eligible professionals with ample time to make an informed decision on which report ing mechanism to use and still provides CMS with advance notification of the group pract ices' chosen reporting mechanism. Based on the comments received, we are finalizing a d eadline of October 15 of the appl icable reporting period (that is, October 15, 2013 for reporting periods occurring in 2013) for group practices to elect (via its self-nomination statement) the reporting mechan ism they will use to submit quality measures data for PQRS. Additionally, should a group pr actice wish to switch th e reporting mechanism it chose when self-nominating, the group practice will be allowed to do so as long as the group practice switches its reporting mechanism prior to the October 15 deadline. Please note that the ability to elect the ad ministrative claims-based reporting mechanism will not be available until the summer of the a pplicable reporting period. Therefore, should a group practice self-nominate earlier, if the group practice elects to use the administrative claimsbased reporting mechanism, the group practice woul d have to visit the we b-page to elect the administrative claims-based reporting mechanism. (3) Process to Participate in the GPRO Please note that, for group practices part icipating in PQRS through other Medicare programs (such as but limited to those group pr actices participating as Accountable Care Organizations (ACOs) under the Medicare Shared Sa vings Program), certain provisions in this section may not apply. For information on how to participate in PQRS through other Medicare programs, please refer to the requirements for those respective programs. Determining Group Practice Size . Please note that if a gr oup practice participates in PQRS as a group practice, the e ligible professionals in the selected group practice cannot851 participate in the PQRS indivi dually. When selecting group pr actices to participate in the GPRO, CMS bases its decision on the information the group pract ice provides in its selfnomination statement. We believe that changes in a group practice’s size or TIN constitute such a significant change in the group practice’s com position that it would cause CMS to reconsider its decision to allow the group practice to partic ipate in the GPRO for the applicable program year. Specifically, we unders tand that a group practice’s size may vary throughout the program year. For example, we understand that eligible professionals ente r into and leave group practices throughout the year. Similarly, we understa nd that group practices may undergo business reorganizations during the program year. We note that size fluctuations ma y affect the criteria under which a group practice would use to report after being selected to participate in the GPRO. We proposed that groups of varyi ng sizes be subject to different criteria for satisfactory reporting for the 2013 and 2014 incentives, as well as for the payment adjustments (77 FR 44822-44833). Therefore, we proposed that, for analysis pu rposes, the size of the group practice must be established at the time the group practice is selected to participate in the GPRO. We invited but received no public comment on this proposal (77 FR 44807). Therefore, we are finalizing this proposal Changes in GPRO TIN . We also understand that, for various reasons, a group practice may change TINs within a program year. For example, a group practi ce may undergo a mid-year reorganization that leads to the group practice changing its TIN mid- year. We proposed that, if a group practice changes its TIN after the group practice is selected to participate in the GPRO, the group practice cannot continue to participate in PQRS as a group practice. We considered the changing of a group practice’s TIN a significant change to the ma keup of the group practice, as the group practice is evaluated under the TIN th e group practice provided to CMS at the time the group is selected to participate in the GPRO for the applicable year (77 FR 44807). Therefore,852 we viewed a group practice that changes its TIN as an entirely new practice, associated with a new TIN. We noted that this proposal may pos e a disadvantage for t hose group practices who find it beneficial to report PQRS quality measures using the GPRO. However, we noted that eligible professionals in a gr oup practice that has changed its TIN within a year may instead participate as individuals. We invited public comment on this proposal. The following is summary of the comments we received regarding this proposal not to allow gro up practices who change their TINs to continue to participate in th e GPRO for the applicable program year.
Comment : Some commenters urged CMS to allo w group practices using the GPRO that subsequently change their TIN within a program year to continue partic ipating in PQRS as a group practice. One commenter noted that not a llowing a group practice to continue to use the GPRO should the group practice cha nge their TIN in a program year is a hindrance to practice mergers and reorganizations. Response : We appreciate the commenters' feedbac k. It is not our intention to hinder group practices from merging with another pr actice or reorganizing. However, it is not operationally feasible to allow a group practice selected to partic ipate in the GPRO that changes its TIN within a program year to continue to participate in PQ RS under the GPRO. Therefore, we are finalizing our proposal to require that a group practice maintain the same TIN throughout a given program year to continue to participate in the GPRO. We note that group practices will now be given until October 15 to self-nominate and select its reporting mechanism for the GPRO, allowing more time with in the program year for grou p practices to organize its composition and ultimately its reporting structur e. We note that, should a group practice change its TIN, eligible professionals within the group practice have the option to participate in PQRS individually.853 GPRO Opt-out Period . We understand that a group practi ce may decide not to participate in PQRS using the GPRO after being selected. Therefore, we proposed that group practices be provided with an opportunity to opt out of part icipation in the GPRO after selection (77 FR 44807). We noted that it is necessary for a group practice to indicate to CMS the group practice’s intent not to use the GPRO because, once a group practice is selected to participate in the GPRO for the applicable reporting peri od, CMS will not separate ly assess the NPIs associated with the group practice’s TIN to see if they meet the criteria for satisfactory reporting as individual eligible professi onals. Therefore, we must be notified of the group practice’s decision not to participate in the GPRO so the eligible professionals within the group practice could be assessed at the individu al TIN/NPI level. We proposed that group practices would have until April 1 of the year of the applicable reporting period (for example, by April 1, 2013 for reporting periods occurring in 2013) to opt out of participating in the GPRO. We invited public comment on the proposed selection process for group practices wishing to participate in the GPRO. The following is summary of the comments we received regarding this proposed opt-out period for group practices that ha ve elected to participate in PQRS under the GPRO.
Comment : One commenter supported our proposal to provide an opt-out period for those group practices who self-nominated to participate in the GPRO but later deci de to participate at the individual level. Response : We appreciate the commenter's feedbac k. We have historically provided an opt-out period, because the deadline for a group pract ice to submit a self-nomination statement to participate in the GPRO has normally been on or about January 31 of the applicable program year. We believed it was necessary to provide an opt-out period for group practices, as we required group practices to submit a self-nomin ation statement indicating their intent to854 participate in the GPRO early in the year. Howe ver, since, as we discussed above, beginning in 2013, group practices will have unt il October 15 of the applicable program year to submit its self-nomination statement, we believe that this opt-out period is no longer necessary. Therefore, we are not finalizing an opt-out period for group practices that are selected to participate in the GPRO for the applicable program year. Once a group practice is selected and approved to participate in the GPRO, past th e opt-out period, the group practice wi ll be required to participate in the GPRO for the applicable program year. c. Requirement for Eligible Professiona ls and Group Practices Electing to Use the Administrative Claims-based Reporting M echanism for the 2015 Payment Adjustment

Unlike using the traditional PQRS reporting m echanisms (that is, claims, registry, EHRs, GPRO web interface) to satis fy the reporting requirements for the 2015 and 2016 payment adjustments, we proposed that eligible profe ssionals and group practices wishing to use the proposed administrative claims reporting mech anism, available for the 2015 and/or 2016 payment adjustments, must elect to use the ad ministrative claims reporting mechanism (77 FR 44805). We believed this election requirement is important because it is necessary for eligible professionals to actively engage in quality reporting. By requiring registration, eligible professionals and group practices are making an active choice in how they would like their quality performance measured. For eligible prof essionals, we proposed that this election process would consist of a registration statement that included: the eligible professional’s name and practice name, the eligible professional’s TIN and NPI for analytical purposes, and the eligible professional’s contact informa tion (77 FR 44806). For group pract ices, we proposed that this election process would also consist of a registra tion statement that include d: the group practice’s business name and contact information, the group practice’s TIN, and contact information of the855 group practice’s contact(s) who will be contacted for program, clinical, and/or technical purposes. For the method of submitting this regi stration statement, we proposed any of the following options:

● If technically feasible, submission of this statement via the web; and

● If technically feasible, submission of an eligible professional’s or group practice’s intent to register to use the administrative claims-based reporting mechanism by placing a Gcode on at least 1 Medi care Part B claim. In the event the two proposed options are not technically f easible, we also considered allowing for submission of the registration statem ent by submitting a mailed letter to CMS at Centers for Medicare & Medicaid Services, Cent er of Clinical Standards and Quality, Quality Measurement and Health Assessment Group, 7500 Security Boulevard, Mail Stop S3-02-01, Baltimore, MD 21244-1850. However, we noted that using this mailing option would be a more burdensome and time-intensive process for CMS. The eligible professional would be required to complete this elect ion process by January 31 of the applicable payment adjustment repor ting period (for example, by January 31, 2013 for the 2015 payment adjustment). However, we noted that we proposed that we may extend this deadline based on the submission method that we finalized. For example, because processing mailed letters would take the longest to process (out of the 3 methods ), we anticipated that if we were to include the option of mailed letters, the deadline for submitting a mailed registration letter would be January 31 of the applicable payment adjustment re porting period. Since it would be more efficient to pro cess registration statements receiv ed via the web or via a G-code on a claim, we anticipated that we would be able to extend the registration deadline to as late as December 31 of the applicable payment adju stment reporting period. Once an eligible professional makes an election to participate in PQRS using th e administrative claims-based856 reporting mechanism for the PQRS payment adjust ments, the eligible professional would be assessed under the administrative claims-based reporting mechanism. For group practices participating in the GP RO, we proposed that these group practices would use the 3 methods described above (mailed letter, web, or G-code submission) and have the same deadline as eligible professionals wish ing to elect to use the administrative claimsbased reporting mechanism for an applicable pa yment adjustment. In the alternative, we proposed that a group practice partic ipating in the GPRO would be required to elect to use the administrative claims-based reporting mechanism in its self-nomination statement. We proposed to provide less time for group practices to elect to use the administrative claims-based reporting mechanism because it is necessary for CMS to recei ve this information in the beginning of the applicable reporting period to indicate to CMS how these group practices should be analyzed throughout the reporting period. This early notification is especially important for large group practices, which may have hundreds or thousands of eligible professionals to track as a group practice. Therefore, we felt it was appropriate to request that a group practice elect to use the administrative claims-based reporting mechanis m when the group practice self-nominates. We further proposed that an eligible prof essional or group practice would be required to make this election for each payment adjustment y ear the eligible profe ssional or group practice seeks to be analyzed under this mechanism. Fo r example, if the eligible professional seeks to report under the administrative claims mechanism for the 2015 and 2016 payment adjustments, the eligible professional would be required to make this election by the applicable deadline, for the 2015 payment adjustment and again by the applicable deadline, for the 2016 payment adjustment. We invited public comment on th e proposed election requirement for eligible professionals and group practi ces electing to participat e in the 2015 and 2016 payment adjustments using the administrative claims-based reporting mechanism.857 We invited public comment on the process fo r electing the administrative claims-based reporting option for eligible professionals and group practices. The following is a summary of the comments received on this proposed pr ocess and on the proposed election requirement.
Comment : Some commenters requested that the deadline for electing the administrative claims-based reporting option be extended. The co mmenters believed eligible professionals and group practices needed more time to understand the different reporting options and determine whether the administrative claims-based repor ting option would be appropriate for their respective practices. Response : We agree with the commenters a nd would like to provide eligible professionals and group practices with sufficient time to make an informed decision as to whether to elect the administrative claims-based reporting option. Therefore, we are extending the timeframe that eligible professionals and gr oup practices have for el ecting the administrative claims-based reporting mechanism. However, as we explain in greater deta il below, we are not finalizing the administrative claims-based reporting option for the 2016 PQRS payment adjustment. For the 2015 payment adjustment, eligible professionals and group practices may begin to make an election in the summer of th e applicable reporting period. The deadline for electing the administrative claims-based reporting mechanism will be October 15 of the applicable reporting period for bot h eligible professiona ls and group practices. For example, for the 2015 payment adjustment, eligible professionals and group practices will be able to elect the administrative claims-based reporting mechanism until October 15, 2013. Therefore, based on the comments received, we are finalizing the following election process for eligible professiona ls and group practices wishing to use the admini strative claimsbased reporting option for the 2015 PQRS payment adjustment. We note that we are changing the name of this process from a registration to an election process. We believe using the term858 election process is more appropria te, as individuals and group prac tices would be electing to be analyzed under a reporting mechanism, not register ing to participate in PQRS (as registration is not a requirement to participate in PQRS). Th is election process is th e same process as the registration process proposed, with the following exceptions:

● We proposed three methods of accepting this election: via the web, a G-code on claims, or, if neither were technically feasible, via U.S. mail. We are finalizing submission of the administrative claims election statement via th e web, because we believe that this is the most efficient method of accepting these elections. Howe ver, in the event that we experience issues with accepting election statements via the web, we are finalizing a back-up method of accepting elections via U.S. mail. In the event the we experience issues with accepting election statements via the web, eligible professi onals and group practices may el ect to be analyzed under the administrative claims-based reporting mechanism by submitting a mailed letter to CMS at Centers for Medicare & Medicaid Services, Cent er of Clinical Standards and Quality, Quality Measurement and Health Assessment Group, 7500 Security Boulevard, Mail Stop S3-02-01, Baltimore, MD 21244-1850.

● The final deadline for submitting the admi nistrative claims election statement to participate using the administrative claims reporting mechanism for the 2015 PQRS payment adjustment for both individual e ligible professionals, and gr oup practices is October 15, 2013. Group practices will be able to make this elec tion under its self-nominatio n statement. As we discussed above, we are finalizi ng a later deadline so that el igible professionals and group practices have more time to determine which re porting mechanism would be more advantageous for their respective practices. We note that, sh ould we encounter issues with accepting election statements via the web, we may extend the deadli ne for submitting these administrative claims election statements to account for any time the web may not be properly functioning.859 We are modifying newly created §414.90(h) to indicate this election requirement for individual eligible professionals and group practices who wish to use the administrative claimsbased reporting option for the 2015 PQRS payment adjustment. Please note that, for group practices part icipating in PQRS through other Medicare programs, the administrative claims-based repo rting mechanism may not be a reporting option for reporting PQRS measures. For example, under the Medicare Shared Savings Program, eligible professionals within Accountable Care Organizations (ACOs) mu st report for purposes of the PQRS using the GPRO web interface (77 FR 67870). Therefore, group practices participating within ACOs participating in the PQRS under the Medicare Shared Savings Program cannot participate in the traditional PQ RS or report using the administrative claimsbased reporting mechanism. 2. Reporting Periods for the PQRS Payment Adjustments For the PQRS incentives, we previously es tablished 12 and 6-mont h reporting periods for satisfactorily reporting PQRS quality meas ures at §414.90(f)(1). Under section 1848(a)(8)(C)(iii) of the Act, we are authorized to specify the quality reporting period (reporting period) for a payment adjustment year. We propo sed to modify the regulation to establish the reporting periods for the PQRS payment ad justments for 2015 and beyond (77 FR 44808). Please note that we are re-d esignating §414.90(f) as §414.90(g) a nd making technical changes to change the structure of the regulation and to im prove the readability of the regulation. Newly designated §414.90(g)(1) indicates the reporting periods availabl e for the PQRS incentives. Additional Reporting Periods for the 2015 and 2016 PQRS Payment Adjustments. For the 2015 payment adjustment, in the CY 2012 Medi care PFS final rule, we established CY 2013 (that is, January 1, 2013 through December 31, 2 013) as the reporting period for the 2015 payment adjustment (76 FR 73392). We esta blished a 12-month reporting period occurring 2860 years prior to the application of the payment adjustments for group practices and for individual eligible professionals to allow time to perfor m all reporting analysis pr ior to applying payment adjustments on eligible professiona ls’ Medicare Part B PFS claims. However, we noted that we might specify additional reporting periods for th e 2015 payment adjustment. To coincide with the 6-month reporting period associated with the 2013 incentive for the reporting of measures groups via registry, we proposed to modify the regulation at ne wly designated §414.90(h) to add a 6-month reporting period occurring July 1, 2013—December 31, 2013, for the 2015 payment adjustment for the reporting of measures groups via registry (77 FR 44808). For the 2016 payment adjustment, to coinci de with the reporting periods for the 2014 incentive, we proposed to modify the regulati on at newly designated §414.90(h) to specify a 12-month (January 1, 2014 – December 31, 2014) a nd, for individual eligible professionals reporting measures groups via registry only, a 6-month (July 1, 2014—December 31, 2014) reporting period for the 2016 payment adjustments. We invited public comment on our proposed reporting periods for the 2015 and 2016 payment adjustments. The following is a summary of the comments we received on our proposals.
Comment : Some commenters supported our prop osal to establish a 6-month payment adjustment reporting period for the 2015 and 2016 PQRS payment adjustments to coincide with the 6-month reporting period for the 2013 and 2014 PQRS incentives. Some commenters also supported our proposal to establish a 12-month payment adjustment reporting period for the 2016 PQRS payment adjustment. One commente r believes that a 12-month reporting period provides a more accurate assessment of actions performed in a clinical setting than data collected based on a 6-month reporting period. Other co mmenters supported continuing to allow a 6- month and 12-month reporting period.861
Response : Based on the comments received and to parallel the reporting periods for the 2013 and 2014 PQRS incentives, we are finalizing the addition of a 6-mo nth reporting period for the 2015 and 2016 PQRS payment adjustments as proposed. We are al so finalizing the 12- month reporting period for the 2016 PQRS payment adjustment. We are therefore finalizing newly created §414.90(h) to specify 6- and 12-mont h reporting periods occurr ing 2 years prior to the 2015 and 2016 PQRS payment adjustments. With respect to the commenter’s concern that a 6-month reporting period may not provide as accurate of a pict ure of the quality of care provided than the 12-month period, we generally agree with the commenter. However, our desire to align the reporting periods of the 2013 and 2014 PQRS incentive and 2015 and 2016 PQRS payment adjustments, and afford additional reporting options, outweig hs this interest. We also note that the 6-month reporting period will only be available for individual eligible professional s reporting measures groups via registry. Reporting Periods for the 2017 PQRS Payment Adjustment and Beyond. We believe that data on quality measures collected based on 12 m onths provide a more accurate assessment of actions performed in a clinical setting than da ta collected based on a 6-month reporting period, as eligible professionals would report on a larger set of patie nts. We stated that it was our intention to move towards using solely a 12-month re porting period once the reporting periods for the 2013 and 2014 incentives conclude. Therefore, fo r payment adjustments occurring in 2017 and beyond, we proposed to modify the regulation at newly designated §414.90(h) to specify only a 12-month reporting period occurring January 1—D ecember 31, that falls 2 years prior to the applicability of the respective payment adju stment (for example, January 1, 2015 through December 31, 2015, for the 2017 payment adjustment) (77 FR 44808).862 We invited public comment on our proposal to establish a 12-month reporting period for payment adjustments occurring in 2017 and beyond. The following is a summary of the comments we received on this proposal.
Comment : One commenter supported our proposa l to eliminate the 6-month reporting period for 2015 and beyond, because the commenter believes that data collected based on 12 months provides a more accurate assessment of acti ons performed in a clinical setting than data collected based on a 6- month reporting period. Response : We agree with the point raised by the commenter and are therefore not finalizing a 6-month period for payment adjust ments occurring in 2017 and beyond. However, we note that we did not propose to eliminate the 6-month reporting period for 2015 and beyond. Rather, we simply did not propose a 6-mont h reporting period for payment adjustments occurring in 2017 and beyond (77 FR 44808).
Comment : Several commenters opposed our proposal to base the PQRS payment adjustment year on a reporting period occurring 2 years prior to the payment adjustment year. The commenters believe that the re porting period should occur clos er to the payment adjustment year. Some commenters urged that the implemen tation of the PQRS payment adjustment should be delayed until the PQRS participation rate increases. Response : We understand the commenters' concer ns on establishing a reporting period 2 years prior to the payment adjustment year. Howe ver, it is not operationally feasible to create a full calendar year reporting period for the PQRS pa yment adjustment any later than 2 years prior to the adjustment year and still avoid retroactive payments or the reprocessing of claims. Section 1848(a)(8) of the Act requires that a payment ad justment be applied to covered professional services furnished by an eligible professional in the particular payment adjustment year. Therefore, using 2017 as an example, we belie ve it is necessary to reduce the PFS amount863 concurrently for PFS allowed charges for covered pr ofessional services furnished in 2017. If we do not reduce the PFS amount concurrently with cl aims submissions in 2017, we would need to potentially recoup or provide added payments afte r the determination is made about whether the payment adjustment applies, or alternatively, hold claims until such a determination is made. In addition, we note that if such retroactive adjust ments were made it may require a reconciliation of beneficiary copayments. As a result, we need to determine whether eligible professionals have satisfactorily reported under the PQRS based on a reporting peri od that occurs prior to 2017. For the reasons stated above, for the PQRS payment adju stments occurring in 2017 and beyond, we are finalizing 12-month reporting periods that fall 2 years prior to th e application of the respective payment adjustment year. For example, th e reporting period for the 2017 PQRS payment adjustment will be CY 2015 (that is, January 1, 2015 – December 31, 2015). We are finalizing newly created §414.90(e) to specify a 12-mont h reporting period for the 2017 PQRS payment adjustments and beyond.
Comment : One commenter supported our propo sal to move towards a 12-month reporting period, provided that we continue to offer the admini strative claims-based reporting option to eligible profe ssionals and group practices. Response : We appreciate the commenter's feedb ack but reiterate that we view the administrative claims-based reporting option as a temporary option under PQRS. Therefore, as we discuss in section III.G.3, we are only fina lizing use of the administrative claims-based reporting mechanism for the 2015 PQRS pa yment adjustment at this time.
Comment : One commenter opposed our proposal to eliminate the 6-month reporting period beginning with the 2017 PQRS payment adju stment, at least until such time as the PQRS achieves greater alignment with other CMS qualit y reporting programs. The commenter believes864 that this alternative reporting pe riod should be maintained to offer greater flexibility in reporting. The commenter also noted that the late start of this 6-month reporting period has traditionally served as an alternative reporting option for eligible professionals who are new to PQRS. Response : We appreciate the commenter's feedback. However, in an effort to streamline the satisfactory reporting requirements under PQRS and to align with programs such as the Value-based Payment Modifier which utilize a performance period of 12 months, we are not adding a 6-month reporting period for paymen t adjustments occurring in 2017 and beyond. 3. Requirements for the PQRS Reporting Mechanisms This section addresses th e following reporting mechanisms: claims, registry, EHR (including direct EHR products and EHR data submission vendor), GPRO web interface, and administrative claims. We prev iously established at §414.90(f)(2) that eligible professionals reporting individually may use the claims, regist ry, and EHR-based reporting mechanisms. We proposed to modify §414.90 to allo w group practices comprised of 2- 99 eligible professionals to use the claims, registry, and EHR-based reporti ng mechanisms as well, because we recognized the need to provide varied repor ting criteria for smaller group pr actices, particularly since we proposed to expand the definition of group practi ce (77 FR 44808). For example, we noted that a smaller group practice may not have a sufficiently varied practice to be able to meet the proposed satisfactory reporting cr iteria for the GPRO web interface that would require a smaller group practice to report on all of the PQRS quality measures we proposed. We proposed changes to §414.90, which we proposed to re-designate §414.90(g) and §414.90(h). We invited public comment on this proposal to make the claims, registry, and EHR-based reporting options applicable to group practices of 2-99 eligible professionals. The following is summary of the comments we rece ived regarding this proposal.
Comment : Several commenters supported our pr oposal to expand the claims, registry,865
direct EHR, and EHR data submission vendor re porting mechanisms to group practices or 2-99 eligible professionals using the GPRO. Commenter s were pleased that gr oups that are not able to use the GPRO web interface (such as speci alty provider group practices for which GPRO measures typically do not apply) would still be able to participate in PQRS as a group practice in the GPRO. Most of these commenters suggested that we extend use of the claims, registry, direct EHR, and EHR data submission vendor re porting mechanisms to group practices of 100 or more eligible professionals to allow greater flexibility in reporting for these larger group practices. These commenters noted that extendi ng the claims, registry, and EHR-based reporting options would be especially beneficial to larg e specialty groups for which the GPRO measures do not apply. Response : We appreciate the commenters’ positive feedback regarding these proposals. Although we proposed to expand the claims-based reporting mechanism to group practices of 2- 99 eligible professionals, we have discovered that it will not be technically feasible to accept group practice reporting data via the claims-based reporting mech anism at this time. Therefore, we are not finalizing that part of our proposal. However, we w ill work to provide group practice reporting via the claims-based reporting mechanism in the future. As for the registry-based reporting mechanism, we are finalizing our proposal to extend the registry-based reporting mechanism to groups practices comprised of 2-99 eligible professionals participating in PQRS via the GPRO for 2013 and beyond. For groups practices of 2-99 eligible prof essionals using direct EHR and EHR data submission vendor products, we are delaying ava ilability of this option until 2014 to coincide with when the EHR Incentive Program introdu ces its group practice re porting option for meeting the clinical quality measures (CQM) objective for achieving m eaningful use (77 FR 54076 through 54078). Therefore, in this final rule, we are adopting the EHR-based reporting866 options for groups of 2-99 eligible professionals participating in PQRS via the GPRO for 2014 and beyond. As for extending use of the registry a nd EHR-based reporting mechanisms for GPRO group practices of 100 of more eligible professionals, we ag ree with the commenters that extending the registry and EHR- based reporting mechanisms woul d provide more opportunities for large specialty group practices to participate in PQRS. Th erefore, based on the comments received, we are finalizing the registry-based reporting mechanism for 2013 and beyond and the EHR-based reporting mechanisms for 2014 and beyond for groups of 100 or more eligible professionals under the GPRO as well as those gr oup practices with 2-99 eligible professionals under the GPRO. Therefore, we are finalizi ng §414.90(g) and §414.90(h) to indi cate that the registry-based reporting mechanism will be available for use by eligible professionals and group practices beginning in 2013 and the EHR-ba sed reporting mechanisms (direct EHR product and EHR data submission vendor) will be available for use by eligible professiona l and group practices beginning in 2014 to report for the PQRS incentives and payment adjustments. a. Claims-based Reporting: Requirements for Using Claims-based Reporting for 2013 and Beyond Eligible professionals that wish to report data on PQRS quality measures via claims for the incentives and for the payment adjustments mu st submit quality data codes (QDCs) on claims to CMS for analysis. QDCs for the eligible professional’s selected PQRS (individual or measures groups) quality measures that are reported on claims may be submitted to CMS at any time during the reporting period for the respective program year . However, as required by section 1848(m)(1)(A) of the Act, all claims for services furn ished during the reporting period, would need to be processed by no later than the la st Friday occurring 2 m onths after the end of867 the reporting period, to be included in the program year’s PQRS analysis. For example, all claims for services furnished during a reporti ng period that occur during calendar year 2013 would need to be processed by no later than the la st Friday of the second month after the end of the reporting period, that is, pr ocessed by February 28, 2014 for th e reporting periods that end December 31, 2013. In addition, after a claim has been submitted and processed, we proposed at re-designated §414.90(g)(2)(i)(A) and newly added §414.90(h)(2)(i)(A ) to indicate that EPs cannot submit QDCs on claims that were previously submitted and processed (for example, for the sole purpose of adding a QDC for the PQRS). We invited public comment on our proposed requirements for using the claims-based reporting mechanism for the incentives and fo r the payment adjustments for 2013 and beyond. The following is a summary of the comment s we received rega rding these proposals.
Comment : Some commenters disagreed with our proposal not to allow the resubmission of claims for the sole purpose of a ttaching a reporting code on a claim. Response : We understand that there are instances where Medicare Part B claims are resubmitted and reprocessed. However, to avoid unn ecessary reprocessing of claims for the sole purpose of reporting PQRS quality data, and because it is overly burdensome and costly to analyze claims that are resubmitted to identify the submission of additional codes for the PQRS, we are finalizing our proposal. We note that this has been a program policy since the inception of PQRS in 2007. Therefore, we are finaliz ing §414.90(g)(2)(i)(A) a nd §414.90(hg)(2)(i)(A), with some technical changes to th e language we are making in this fi nal rule, to indi cate that if an eligible professional re-subm its a Medicare Part B claim for reprocessing, the eligible professional may not attach a G-code at that time for reporting on individual Physician Quality Reporting System measures or measures groups. b. Registry-based Reporting868 (1) Proposed Qualification Requirements for Registries for 2013 and Beyond For 2013 and beyond, we proposed that regist ries wishing to submit data on PQRS quality measures for a particular reporting pe riod would be required to be qualified for each reporting period the registries wish to submit quality measures data (77 FR 44808). This qualification process is necessary to verify that registries are able to submit data on PQRS quality measures on behalf of elig ible professionals and group pract ices to CMS. Registries who wish to become qualified to report PQRS quality measures for a reporting period undergo (1) a self-nomination process and (2) a qualification process regardle ss of whether the registry was qualified the previous program year. Registry Self-nomination Process . For the self-nomination process, we proposed that the self-nomination process would consist of th e submission of a self-nomination statement submitted via the web by January 31 of each year in which the registry seeks to submit data on PQRS quality measures on behalf of eligible professionals and group practices (77 FR 44809). For example, registries that wish to become qualified to report data in 2013 under the program, that is, to report during all of the reporting periods for the 20 13 incentive and the 2015 payment adjustment, would be required to submit its self-nomination statement by January 31, 2013. We proposed that the self -nomination statement contain a ll of the following information:

● The name of the registry.

● The reporting period start da te the registry will cover.

● The measure numbers for the PQRS quality measures on which the registry is reporting. We noted that CMS is currently developing the functionality to accept registry selfnomination statements via the web and anticipat e development of this functionality to be complete for registries to submit their self-nom ination statements via the web in 2013. However,869

in the event that it is not techni cally feasible to collect this self-nomination statement via the web, we proposed that registry vendors would su bmit its self-nomination statement via a mailed letter to CMS (77 FR 44809). The self-nomina tion statement would be mailed to the following address: Centers for Medicare & Medicaid Services , Center for Clinical Standards and Quality, Quality Measurement and Health Assessmen t Group, 7500 Security Boulevard, Mail Stop S3- 02-01, Baltimore, MD 21244-1850. We proposed that th ese self-nomination statements must be received by CMS by 5:00 p.m. East ern Standard Time on January 31 of the applicable year. We invited public comment on our proposals re lated to the regist ry self-nomination process. The following is a summary of these comments.
Comment : One commenter suggested that we extend the proposed self-nomination deadline of January 31 for registries who wish to become qualified to submit PQRS measures data should we finalize the option to submit th is self-nomination statement via U.S. mail. Response : Based on our desire to streamline th e self-nomination process, we are finalizing our proposal to accept the registry self -nomination statements via the web. However, we understand that issues may arise with respec t to the web-based self-nomination process. Therefore, we are finalizing the proposed back -up submission method. Specifically, only in the event that we encounter issues accepting registry self-nomination statements via the web, we are finalizing our proposal to accept self-nomination st atements from registries who wish to become qualified to submit PQRS measures data to CMS via U.S. mail. The self-nomination statement will be mailed to the following address: Centers for Medicare & Medicaid Services, Center for Clinical Standards and Quality, Quality M easurement and Health Assessment Group, 7500 Security Boulevard, Mail Stop S3-02-01, Baltimore, MD 21244-1850. We are also finalizing the deadline of Ja nuary 31. Although we agree that submitting a self-nomination statement via U.S. mail would re quire more time to complete than submitting870
the self-nomination statement via the web, we do not believe an extended submission deadline is warranted since registries (such as those part icipating in PQRS in 2012) are familiar with submitting self-nomination statements by January 31 via U.S. mail. Beginning 2013, registries wishing to indicate their intent to submit PQRS measure data on be half of eligible professionals are required to submit a self-nomination statement for each year in which the registry seeks to participate in PQRS. Please note that when su bmitting self-nomination statements via the web, registries are required to meet CMS’ security and system requirements. Should a registry wishing to self-nominate encounter issues using the web, the registry may contact the QualityNet Help Desk for assistance in submitting a self-nomination statement.

Comment : One commenter suggested that we extend the proposed self-nomination deadline of January 31 for registries who wish to become qualified to submit PQRS measures data to CMS. The commenter believes that, sinc e we are proposing new criteria for registries, the registries should be provided with more time to make any needed changes prior to submitting its self-nomination statement. Response : We understand that registries need ti me to decide whether to undergo the qualification process to submit PQRS measures data to CMS. However, extending the selfnomination deadline would delay our ability to make the list of qualified registries available to eligible professionals and group pr actices for a particular repor ting period. We note that the deadline for registries to submit a self-nominati on statement has historically been January 31 of the year in which the registry seeks to become qualified. The January 31 deadline has provided registries with sufficient time to submit self-nom ination statements in the past, even when new requirements were established for registries, so we do not believe it is necessary to extend the self-nomination deadline for regist ries past January 31 of the year in which the registry seeks to871 become qualified. In addition, as previously stated, beginning 2013, we are accepting registry self-nomination statements via the web. We belie ve this will provide regi stries with more time to submit their self-nomination statements, as re gistries will not have to account for the time ittakes for CMS to receive its self-nomination statement via U.S. mail. Please note that the selfnomination statement simply indicates to CMS a re gistry’s intent to participate in PQRS. The process to become a qualified registry, which fo llows this discussion, oc curs after the deadline for registries to submit its se lf-nomination statement. Registry Qualification Process . For the qualification pro cess, we proposed that all registries, regardless of whether or not they have been qualified to report PQRS quality measures in a prior program year, undergo a qu alification process to verify that the registry is prepared to submit data on PQRS quality measures for the repor ting period in which the registry seeks to be qualified (77 FR 44809-44810). To become qualifie d for a particular reporting period, we proposed that a registry would be required to:

● Be in existence as of January 1 the year pr ior to the program year in which the registry seeks qualification (for example, January 1, 2012 , to be qualified to submit data in 2013).

● Have at least 25 participants by January 1 the year prior to the program year in which the registry seeks qualification (for example, January 1, 2012, to be qualified for the reporting periods occurring in 2013).

● Provide at least 1 feedback report to participating eligible professionals and group practices for each program year in which the re gistry submits data on PQRS quality measures on behalf of eligible professionals and group practices. This feedb ack reporting would be based on the data submitted by the registry to CMS fo r the applicable reporting period or periods occurring during the program year. For example, if a registry was qualified for the reporting periods occurring in 2013, the regi stry would be required to provi de a feedback report to all872 participating eligible professionals and group practices based on all 12 and 6-month reporting periods for the 2013 incentive and the 12-month reporting period for 2015 payment adjustment. Although we proposed to require that qualified regist ries provide at least 1 feedback report to all participating eligible professionals and group prac tices, we encouraged regi stries to provide an additional, interim feedback repo rt, if feasible, so that an e ligible professional may determine what steps, if any, are needed to m eet the criteria for satisfactory reporting.

● For purposes of distributing feedback reports to its participating eligible professionals and group practices, the registry must collect ea ch participatin g eligible professional’s e-mail address and have documentation from each partic ipating eligible professional authorizing the release of his or her e-mail address.

● Not be owned or managed by an individu al, locally-owned, singl e-specialty group (for example, single-specialty practices with only 1 practice location or solo practitioner practices would be precluded from becomi ng a qualified PQRS registry).

● Participate in all ongoi ng PQRS mandatory support conf erence calls and meetings hosted by CMS for the program year in which the re gistry seeks to be qualified. For example, a registry wishing to be qualified for reporting in 2013 would be required to participate in all mandatory support conference calls hosted by CMS related to reporting in 2013 under the PQRS.

● Be able to collect all needed data el ements and transmit to CMS the data at the TIN/NPI level for at least 3 measures.

● Be able to calculate a nd submit measure-level reporting rates and/or, upon request, the data elements needed to calcula te the reporting rates by TIN/NPI.

● Be able to calculate and submit, by TI N/NPI, a performance rate (that is, the percentage of a defined population who receive a particular process of care or achieve a particular outcome based on a calculation of the measure’s numerator and denominator873 specifications) for each measure on which the eligible professional (as identified by the TIN/NPI) or group practice reports and/or, upon request, the Medicare beneficiary data elements needed to calculate the reporting rates.

● Be able to separate out and repo rt on Medicare Part B FFS patients.

● Report the number of eligible instances (reporting denominator).

● Report the number of instan ces a quality service is perf ormed (reporting/performance numerator).

● Report the number of perf ormance exclusions, meaning the quality action was not performed for a valid reason as defined by the measure specification.

● Report the number of reported instances, performance not met, meaning the quality action was not performed for any valid reason as defined by the measure specification. Please note that an eligible professional receives credit for reporting, not performance.

● Be able to transmit data on PQRS quality measures in a CMS-approved XML format.

● Comply with a CMS-specified secure method for data submission, such as submitting the registry’s data in an XML file through an identity management system specified by CMS or another CMS-approved method, such as use of appropriate Nationwide Health Information Network specifications, if technically feasible.

● Submit an acceptable “validation strategy” to CMS by March 31 of the reporting year the registry seeks qualification (for example, if a registry wishes to become qualified for reporting in 2013, this validation strategy woul d be required to be submitted to CMS by March 31, 2013). A validation strategy details how the registry will determine whether eligible professionals and group practices have submitted accurately and on at least the minimum number (80 percent) of their eligible patients, visits, procedures, or episodes for a given measure. Acceptable validation strategies often include such provisions as the registry being able to874 conduct random sampling of their participant’s da ta, but may also be based on other credible means of verifying the accuracy of data content and completeness of reporting or adherence to a required sampling method.

● Perform the validation outlined in the strategy and send the results to CMS by June 30 of the year following the reporting period (for ex ample, June 30, 2014, for data collected in the reporting periods occurring in 2013).

● Enter into and maintain with its partic ipating professionals an appropriate Business Associate agreement that provides for the registry ’s receipt of patient-specific data from the eligible professionals and group prac tices, as well as the registry’s disclosure of quality measure results and numerator and denominator data a nd/or patient-specific data on Medicare beneficiaries on behalf of eligible professionals and group practices who wish to participate in the PQRS.

● Obtain and keep on file signed documentati on that each holder of an NPI whose data are submitted to the registry has authorized th e registry to submit quality measure results and numerator and denominator data and/or patient-specific data on Medicare beneficiaries to CMS for the purpose of PQRS participation. This doc umentation would be requi red to be obtained at the time the eligible professional signs up with the registry to submit PQRS quality measures data to the registry and woul d be required to meet any app licable laws, regulations, and contractual business associate agreements.

● Upon request and for oversight purposes, provide CMS access to review the Medicare beneficiary data on which PQRS registry-based submissions are founded or provide to CMS a copy of the actual data.

● Provide CMS a signed, written attestation statement via mail or e-mail which states that the quality measure results and any and all data including numerator and denominator data875 provided to CMS are ac curate and complete.

● Use PQRS measure specifications a nd the CMS provided measure calculation algorithm, or logic, to calculate reporting rates or performance rates unless otherwise stated. We will provide registries a standard set of logic to calculate each measure and/or measures group they intend to report for each reporting period.

● Provide a calculated result using the CM S-supplied measure calculation logic and XML file format for each measure that the registry intends to calculate. The registries may be required to show that they can calculate the proper measure results (that is, reporting and performance rates) using the CMS-supplied logic and send the calculated data back to CMS in the specified format. The registries will be required to send in test files with fictitious data in the designated file format.

● Describe to CMS the cost for eligible professionals and group practices that the registry charges to submit PQRS and/or eRx Incentive Program data to CMS.

● Agree to verify the info rmation and qualifications for the registry prior to posting (includes names, contact, measures, cost, etc.) an d furnish/support all of th e services listed for the registry on the CMS Website.

● Agree that the registry’s data for Medica re beneficiaries may be inspected or a copy requested by CMS and provided to CMS under our oversight authority.

● Be able to report consistent with the sati sfactory reporting criteria requirements for the PQRS incentives and payment adjustments. In addition to meeting all the requirements specified prev iously for the reporting of individual quality measures via registry, for registries that in tend to report on PQRS measures groups, we proposed that these registries, regardless of whether or not registries were qualified in previous years, would be required to:876

● Indicate the reporting peri od chosen for each eligible professional who chooses to submit data on measures groups.

● Base reported information on measures gr oups only on patients to whom services were furnished during the rele vant reporting period.

● If the registry is report ing using the measures group optio n for 20 patients, the registry on behalf of the eligible pr ofessional may include non-identi fiable data for non-Medicare beneficiaries as long as these pa tients meet the denominator of the measure and the eligible professional includes a majority of Medicare Part B patients in thei r cohort of 20 patients for the
measures group. We intend to post the final list of regist ries qualified for eac h reporting period by the summer of each year in which the reporti ng periods occur on the CMS website at http://http://www.cms.gov/Medicare/Qual ity-Initiatives- Patient-AssessmentInstruments/PQRS/index.html . For example, we intend to post the list of registries qualified for 2013 reporting periods by summer 2013. For ea ch reporting period, th e list of qualified registries would contain the following inform ation: the registry name, registry contact information, the measures and/or measures gr oup(s) for which the regi stry is qualified and intends to report for the respective reporting period. The registry qualification process we pr oposed was largely the same process we established to qualify registries for the reporting periods occu rring in 2012. We proposed a similar process to the 2012 qualification process b ecause, registries are already familiar with this qualification process, so we felt there would be a greater likelihood that regi stries wishing to be qualified to report quality measures data for a particular reporti ng period would be able to pass the qualification process. We fe lt this would provide eligible pr ofessionals with more qualified registry products from which to choose.877 We invited public comment on our proposals related to the qualification process for registries. The following is a summary of the comments we received regarding these proposals.
Comment : One commenter asked for clarificati on on our proposal to have a validation strategy. Response : Please note that we do not provide requ irements or guidelines for a validation strategy. Registries must adopt a strategy in the manner the regist ry chooses. Therefore, the specifics of the validation strate gy are dependent on the registry. However, we are finalizing the requirement that a registry seeking to be qualif ied to submit PQRS quality measures data have a validation strategy. As we discuss in further detail in the following response, although we strongly encourage registries to test their validation st rategies with CMS, we are not finalizing this testing requirement.
Comment : One commenter requested that the requireme nt for registries to provide data to CMS should contain the stipulat ion that it be de-identified at the patient level. Response : We have historically reserved the righ t to request patient identifiable data if we so choose. We understand the security con cerns around patient-identified data and will work with the registry to receive th e data in a secure manner.
Comment : One commenter recommended that the fina l list of qualified PQRS registries be available earlier than the summ er of each reporting period. Response : We realize that it may be challenging for eligible prof essionals to choose among the numerous registries. Due to the commenter ’s concerns as well as concerns we have heard from other stakeholders re garding the timing of the availabi lity of the qualified registry list, we are not finalizing the following proposed registry qualification requirement: perform the validation outlined in the strategy and send the results to CMS by June 30 of the year following the reporting period (for exam ple, June 30, 2014, for data coll ected in the reporting periods878 occurring in 2013). We note that the delay in pos ting the list of qualified registries was mainly due to our desire to test a regi stry’s validation strategy prior to qualifying the registry to report PQRS quality measures data for the applicable year. Since we are not requiring that this validation strategy be tested, we will be able to post the list of qualified registries sooner. We anticipate that we will post the list of qualified regi stries in the Spring of the applicable year the registries are qualified submit qual ity measures data on behalf of eligible professionals (for example, Spring 2013 for reporting periods occurring in 2013). We note that, although we are not requiring that a registry’s validati on strategy be tested to become qualified to submit PQRS quality measures data on behalf of its eligible professionals, this testing process will still be available for registries to test their respective validation strategies. It is important for registries to unde rgo this testing process to check whether they will be able to submit quality measures data accurately to CMS after the applicable reporting period.
Comment : One commenter sought clar ification on our proposal to, "upon request and for oversight purposes, provide CMS access to revi ew the Medicare beneficiary data on which PQRS registry-based submissions are founded or provide to CMS a copy of the actual data." Specifically, the commenter sought clarification as to whether th is requirement would require that CMS have access to more data than is already required for PQRS. Response : This requirement would not require th at CMS have access to more data than is already required for PQRS. Ra ther, this requirement is necessary in order for CMS to verify the accuracy of the data submitted by the respectiv e registry. As stated previously, CMS will work with registries to accep t data in a secure manner. Based on the comments received and for the re asons stated previously, we are finalizing the registry qualification process for 2014 and be yond, as proposed, with the exception that we are not finalizing the requirement that a registry perform the validation outlined in its strategy879 and send the results to CMS by June 30 of th e year following the reporting period. Registry Audit and Di squalification Process . Lastly, in the CY 2012 Medicare PFS proposed rule, we raised the issue of disqualifying registries that submit inaccurate data (76 FR 42845). We did not adopt a disqualification proce ss but noted the importance of such a process, as well as our intention to provide detailed in formation regarding a disqualification process in future rulemaking (76 FR 73322). In an effort to en sure that registries pr ovide accurate reporting of quality measures data, we proposed to modi fy §414.90(b) to indicate that we would audit qualified registries (77 FR 45044-45045) . If, during the audit process, we find that a qualified registry has submitted grossly inaccurate data , we proposed, under §414.90(b), to indicate that we would disqualify such a registry from the s ubsequent year under the program, meaning that a registry would not be allowed to submit PQRS quality measures data on behalf of eligible professionals and group practices fo r the next year. Under this pr oposal, a disquali fied registry would not be included in the list of qualified registries that is posted for the applicable reporting periods under which the registry attempted to qualify (77 FR 44810). We further proposed to post a registry’s disqualificati on status on the CMS website at https://www.cms.gov/Medicare/Qual ity-Initiatives-Patient-AssessmentInstruments/PQRS/index.html . For example, if a qualified re gistry submits quality measures data for the reporting periods o ccurring in 2013 but is then audited and la ter disqualified, the registry would not be allowed to submit PQRS qu ality measures data on behalf of participating eligible professionals and group practices to CMS for the reporting periods occurring in 2014 or later. One example of submitting grossly inaccurate data that CMS has encountered in the past is if a registry reports inaccurate TIN/NPIs on 5 per cent or more of the registry’s submissions. As CMS calculates data on a TIN/NPI le vel, it is important for regist ries to provide correct TIN/NPI information.880 In proposing registry disqualification, we cons idered other alternatives, such as placing registries in a probationary status . However, we believed it is im portant for registries to submit correct data once it is qualified to submit data on behalf of its elig ible professionals and therefore, find that immediate disqualification to be appropriate. This becomes especially important particularly as the program moves from the use of incentives to payment adjustments (77 FR 44811). We invited public comment as to the threshol d of grossly inaccurate data for the purpose of disqualifying a registry. The following is a summary of the comments we received regarding this proposal.
Comment : One commenter generally supported the establishment of a process to audit qualified registries, but advised CM S to exercise caution when using their authority to disqualify registries, thereby preventing these registries from submitting data on PQRS measures. Response : We understand the consequences of disqualifying a previously qualified registry and will therefore use this authority with caution. It is our intention that disqualification be used only for those registries submitting grossly inaccurate data. However, we stress the importance of having registries provide correct da ta to ensure that eligible professionals and group practices are correctly provided with in centive payments or payment adjustments.
Comment : Should CMS discover that a registry has submitted inaccurate data, one commenter requested that the regi stry be allowed an opportunity to correct their mistakes and rectify any processes leading to data submission errors. Response : We appreciate the commenter's feedback. However, due to the time it takes to perform data analysis for payment determination, it is not technically feasible to allow registries to another opportunity resubmit data that is found to be inaccurate . We note that the registries have until the last Friday of February followi ng the applicable reporting period (for example,881 February 28, 2014 for reporting periods occurring in 2013). After this data submission period, CMS must perform its analysis to determine whethe r eligible professionals have met the criteria for satisfactory reporting for the PQRS incentives or payment adjustments. In order to perform this analysis in time to issue payment adjustme nts beginning January 1 of the applicable payment adjustment year (for example, January 1, 2015 for the 2015 PQRS payment adjustment), CMS cannot provide for an additional opportunity to re submit data that is found to be inaccurate. We note that, although no longer required, regi stries have an opport unity during the year to test its validation and submission strategy wi th CMS prior to submitting the data that CMS will use to determine whether its eligible professi onals or group practices have met the criteria for satisfactory reporting for the PQRS incentives and/or paymen t adjustments. We strongly encourage registries to undergo this testing process, as it will he lp to alleviate issues that may occur when submitting PQRS quality measures data to CMS.
Comment : Some commenters oppose disqualifying re gistries because of inaccuracies in TIN/NPI information provided to CMS by the registri es. One commenter states that registries do not gather TIN/NPI information; rather, outside reporting sites provide TIN/NPI information. Since the registries do not have access to this information pr ovided by these outside sites, registries have no way of verifying the accuracy of TIN/NPI information. Another commenter stated that submission of inaccurate data should be shared by those generating the data, that is, the responsibility of submitting in accurate data should be shared with the registry, its eligible professionals and group practices, as well as ot her entities involved in submitting quality measures data to CMS via a qualified registry. Response : We recognize that registri es are limited to the data they receive from their eligible professionals. It is not our intention to seek to disqua lify registries who, through no fault of their own, submit inaccurate data. However, we believe it is necessary to eliminate or, at a882 minimum, drastically reduce instances where mismatches in TIN/NPI information would result in nonpayment of an incentive or conversely the application of the paym ent adjustment when it appears that the eligible profe ssional or group practice would otherw ise be eligible to receive an incentive. While we understand that registries are reliant on the data they receive from their eligible professionals or group practices, CMS discovered numerous instances where registries have failed to correct data inaccuracies within the purview of a registry's calculations. We understand that registry vendors undergo costs as sociated with qualifying their products to submit data on PQRS measures. We also unde rstand that it would place an added burden on registries who were previously qualified to repeat the qualification process should CMS disqualify the registry. Theref ore, as proposed, it is our inte ntion to limit disqualification of registries to those who submit grossly inaccurate data to CMS.
Comment : One commenter suggested that regist ries in their first year of PQRS participation be provided with lenien cy with regard to disqualification. Response : We note that CMS typically works with registries during the data submission period following a PQRS reporting period to help avoid the reporting of inaccurate data. One example of this is providing the testing process whereby registries may test its validation and submission strategy. In addition, during the subm ission process occurring immediately after the PQRS reporting periods, CMS provides help and guidance to those registries who encounter issues submitting PQRS quality measures data to CMS. Therefore, we do not believe that registries participating in PQRS for the first time are disadvantaged to the point that they should be provided greater leniency. The need for CM S to receive accurate data to determine PQRS incentive and/or payment adjustment applicabilit y outweighs the need to afford newly qualified registries leniency should these regi stries submit grossly inaccurate data.
Comment : One commenter sought cl arification on the followi ng questions: (1) What883 happens to the registry participan ts’ respective data? Ar e their submissions al so “disqualified”? (2) Does a finding of a submission with “grossly in accurate data” by a registry mean that all data collected and submitted by that registry is to be considered “grossly inaccurate”? Response : We appreciate the commenter’s questions . With respect to the first question, if we find that a registry has submitted grossly inaccurate data, the data submitted by its registry participants those reporting periods will be disr egarded. For example, if a registry submits grossly inaccurate data to CMS in 2014 for reporting periods occurring in 2013, the data submitted by the registry on behalf of its eligible professionals and group practices for reporting periods occurring in 2013 will not be accepted by CMS. With respect to the second question, should we find that a registry has submitted gros sly inaccurate data, th e data submitted will be considered inaccurate, and CMS will not accept the data provided. Based on the comments received and for th e reasons stated, we are modifying §414.90(b) to indicate that we are finalizing the proposed disqualification process for registries. Should CMS decide to disqualify a registry, please note that our decision to disqualify a registry is final. Collection of Registry Data via the NwHIN . The Nationwide Health Information Network (NwHIN) is an initiative developed by the Department of Health and Human Services that provides for the exchange of healthcare information. Traditionally, CMS has not collected data received via a registry thr ough NwHIN. However, we strive to encourage th e collection of data via the NwHIN and intend to do so when it is technically feasible to do so (as early as 2014). Therefore, we solicited public comment on colle cting data via registry for PQRS via NwHIN. We received no comments on this prop osal. However, since we believe the NwHIN must be further developed in order to be able to collect registry data via the NwHIN, we are not finalizing any policy to collect da ta via the NwHIN at this time. c. EHR-based Reporting884 (1) Requirements for a Vendor’s Di rect EHR Products for 2014 and Beyond Definition of Direct EHR Product

. We proposed to modify §414.90( b) to define a direct electronic health r ecord (EHR) product as “an electronic health record vendor’s product and version that submits data on Physician Quality Re porting System measures directly to CMS” (77 FR 45053). Please note that the self-nominati on and qualification requi rements for a vendor’s direct EHR products for 2012 and 2013 were establis hed in the CY 2012 Medi care PFS final rule (76 FR 73323). We did not receive public comment on our propos al to modify the definition of a direct electronic health record (EHR ) product (77 FR 44811). Therefor e, we are modifying §414.90(b) to define a direct electronic health record (EHR ) product as “an electronic health record vendor’s product and version that submits data on Physicia n Quality Reporting System measures directly to CMS,” as proposed. Discontinuation of the Qualificati on Process for Direct EHR Products . In the CY 2012 PFS final rule, we established the requirement that direct EHR products that submit PQRS quality measures data to CMS for reporting periods occurring in 2013 be qualified (77 FR 77323). We proposed to no longer require qualifi cation of direct EHR products beginning in 2014 (77 FR 44811). Although we would still allo w EHR vendors to submit test files to the PQRS and continue to provide support calls, we would no longer require vendors to undergo this testing process. Although ve ndors and their products would no longer be required to undergo this testing or qualification pro cess, we proposed that CMS would only accept the data if the data

are:

• Transmitted in a CMS-approved XML format u tilizing a Clinical Document Architecture (CDA) standard such as Quality Reporti ng Data Architecture (QRDA) level 1 and885

• In compliance with a CMS-specified secure method for data submission, such as submitting the direct EHR vendor’s data (for testing) thro ugh an identity management system specified by CMS or another approved method. CMS would therefore no longer post a list of qualified EH R vendors and their products on the CMS website. Therefore, eligible professi onals would need to work with their respective EHR vendor to determine whether their specific EHR product has undergone any testing with the PQRS and/or whether their EHR product can produce and transmit the data in the CMS-specified form and manner. While we no longer believe that this process is necessary, we invited public comment as to whether CMS shoul d continue to require that di rect EHR products undergo selfnomination and qualification processes prior to be ing authorized to submit quality measures data to CMS for PQRS reporting purposes. We proposed to not continue the qualificati on requirement (that is , no longer propose this process for future years of the program) because we believe adequate checks are in place to ensure that a direct EHR product is able to s ubmit quality measures data for the PQRS. For example, to the extent possible, we intend to align with the Medicare EHR Incentive Program for our criteria for satisfactory reporting and meas ures available for reporting under the EHR-based reporting mechanism. The Medicare EHR Ince ntive Program requires that an eligible professional submit clinical quality measures using EHR technology certified under the program established by the Office of the National Coordinator for Health Information Technology (ONC). We anticipated that ONC’s certification process c ould include testing related to the reporting of the proposed PQRS EHR measures indicated in Ta bles 32 and 33, since we proposed to align the PQRS EHR-based measures with the measures available for reporting under the EHR Incentive Program. We invited public comment as to whethe r, in lieu of qualific ation, CMS should require that direct EHR products that would be used to submit data on PQRS quality measures for a886 respective reporting period be classified as certified under the program established by ONC. The following is summary of the comments we received regarding our proposal to discontinue the qualification pro cess for direct EHR products as well as our proposal to require CEHRT in lieu of PQRS qualification.
Comment : Several commenters supported our propos al to discontinue qualification of direct EHR products. The commenters believe th at this proposal moves towards our goal of aligning PQRS and the EHR Incentive Program. The commenters also believe discontinuing qualification of direct EHR vendor products help s to encourage use of the EHR-based reporting mechanism for reporting under PQRS. Response : We appreciate the commenters’ f eedback and, based on the support we received for this proposal and th e reasons we discussed above, we are finalizing our proposal to discontinue qualifying direct EH R products beginning in 2014.
Comment : Should CMS discontinue th e qualification process, one commenter requested that CMS continue to allow EHR vendors the op portunity to submit test files when needed. Response : Although CMS is discontinuing qualifying EHR products, vendors will be able to continue to submit test files. We believe that allowing submission of test files is an important tool for providers and provides an adequate ch eck to determine whethe r the vendor products are able to successfully submit data to CMS.
Comment : Some commenters opposed our proposal to discontinue qualifi cation of direct EHR products. The commenters believed that discontinuing qualificati on will increase burden on providers, who will have no guide to determine whether a direct EHR product is qualified to report PQRS measures. One comm enter therefore urged CMS to c ontinue to qualify direct EHR products until the ONC’s certification process ca n be used for PQRS in addition to the EHR Incentive Program. Another commenter expres sed concern that, shoul d CMS discontinue the887 qualification process for direct EHR products, el igible professionals a nd group practices would simply assume that their CEHRT are able to submit data on measures under PQRS. Response : We understand that our decision to di scontinue the qualification process for direct EHR products puts the onus on eligible professionals and group practices to determine whether a direct EHR product meets the requiremen ts for reporting PQRS measures. However, we have received much stakeholder feedback reque sted that we discontinue the requirement that an eligible professional select a "qualified" direct EHR product; th e stakeholders be lieve that the qualified designation is confusing, because ther e is already certifi cation process in place administered by ONC that tests EHR products. Th erefore, we are finaliz ing our proposal to discontinue the qualification pr ocess for direct EHR products under the PQRS beginning in
2014. Nonetheless, we share the commenter's c oncern to provide guidance to eligible professionals on choosing EHR products. Theref ore, based on the comments received, we are also finalizing to the requirement that a dir ect EHR product be certified by ONC as Certified EHR Technology (CEHRT), and therefore meet th e definition of CEHRT in ONC’s regulations (see 45 CFR 170.102), to submit PQRS measures. (For the 2014 Edition EHR certification criteria, please refer to 77 FR 54163). While th e process for certifying EHR technology may not be distinctly tailored for reporting PQRS quality measures, we note that we are making efforts to align, to the maximum extent possible, the m easures and reporting criteria with the EHR Incentive Program, which requires eligible professi onals to use CEHRT. For example, it is our intention to further align the EHR measures avai lable for reporting by elig ible professionals and group practices under PQRS and the EHR Incentive Pr ogram, so that the specifications of these measures will be the same. Therefore, begi nning in 2014, ONC’s certification process would test the submission of data on CQMs availabl e for reporting under the EHR Incentive Program888 and, consequently, since the measures would be the same, data on PQRS quality measures that are reportable via an EHR. We understand that CEHRT may provide more capabilities than needed to report PQRS quality measures. However, we note that most of these capabilities are intertwined with the direct EHR product’s ability to capture data on quality measures and therefore necessary. The certified health information technology product list (CHPL) includes all EHR technology that has been certified, a nd it can be found at http://oncchpl.force.com/ehrcert?q=CHPL

. Comment : While one commenter generally suppor ted requiring direct EHR products to be ONC certified as CEHRT to report PQRS me asures, the commenter stated that the ONC certification process should onl y be used for the PQRS and EHR Incentive Programs if the measures are identical, particularly in specifications and reporting format. Response : We note the commenter's concern rega rding use of the ONC certification process and the alignment of EHR-based measur es in PQRS and the EHR Incentive Program. As we noted in the previous response, it is our intention to align, to the maximum extent possible, the measures and reporti ng criteria for eligible professionals to meet the criteria for satisfactory reporting under PQRS and the cr iteria for meeting th e CQM component of meaningful use under the EHR Incen tive Program. By 2014, we expect that the measures and reporting criteria available under both programs w ill be sufficiently aligned to justify requiring that an EHR product used to report PQRS quality measures data undergo the ONC certification process. Therefore, we believe that requiring a direct EHR product to be CEHRT in order to be eligible to report measures under PQ RS beginning in 2014 is appropriate.
Comment : One commenter recommended that a certified quality reporting module be considered as a direct EHR product for purpos es of submitting PQRS measures to CMS. Response : We are discontinuing th e qualification process and requiring that a direct889 EHR product be CEHRT beginning in 2014. A certified quality reporting module may be part of CEHRT, but CEHRT as a whole is more comprehe nsive. Please refer to ONC’s standards and certification criteria final rule for additiona l information on requirements for CEHRT (77 FR 54163). The Certified HIT Product Li st CHPL, which is the listing of all certified products, is available at http://oncchpl.force. com/ehrcert?q=CHPL

. Other Requirements for Direct EHR Products. Although we proposed that direct EHR products would no longer be required to undergo this testing or quali fication process, we proposed that CMS would only accept the data if the data are:

● Transmitted in a CMS-approved XML fo rmat utilizing a Clinical Document Architecture (CDA) standard such as Quality Re porting Data Architecture (QRDA) level 1 and

● In compliance with a CMS-specified s ecure method for data submission, such as submitting the direct EHR vendor's data (for testi ng) utilizing an identity management system specified by CMS or another approved method (77 FR 44811). In addition, upon request and for oversight purp oses, we proposed that the vendor would still be expected to provide CMS access to review the Medicare beneficiary data on which PQRS direct EHR-based submissions are founded or pr ovide to CMS a copy of the actual data. We invited public comment on these additi onal proposed requirements for direct EHR products. The following is a summary of comments we received on this proposal.
Comment : One commenter opposed our proposed re quirement that direct EHR vendors would be expected to provide CMS access to re view to Medicare beneficiary data on which PQRS direct EHR-based submissions are founded or provide to CMS a copy of the actual data. Under the direct EHR submission method, healthcar e organizations are submitting data directly to CMS. The vendor does not come into possession of the data being submitted during this process and does not have a copy of the data to provide to CMS. Responsibility for providing890

access to such data must remain with the health care organization. Another commenter expressed HIPAA concerns regarding our proposed require ment that EHR vendors would be expected to provide CMS access to review to Medicare benefi ciary data on which PQRS direct EHR-based submissions are founded or provide to CMS a copy of the actual data. Response : We agree with the concerns the comment ers have raised. Therefore, we are not finalizing the requirement that direct EHR products provide CMS access to review the Medicare beneficiary data upon which the direct vendor's submissions are founded or a copy of the actual data. In summary, we are finalizing the requiremen ts for submitting quality measures data via a direct EHR product, as proposed, with the fo llowing exception: we are not finalizing our proposal to allow CMS access to review the Medi care beneficiary data on which PQRS direct EHR-based submissions are founded or provide to CMS a copy of the actual data. In addition, we note that the EHR Incentive Program has provided an additional format for transmitting quality measures data to CMS from CEHRT. In addition to finalizing the submission of quality measures data using the QRDA Category I format , the EHR Incentive Program also finalized the QRDA Category III transmission format (77 FR 54075). In our proposal, we proposed to require that eligible professionals and group practices using CEHRT transm it quality measures data in a CMS-approved XML format utilizing a Clinical Document Architecture (CDA) standard, and used QRDA Category I as an example. Since it was our intent to align with the EHR Incentive Program, who finalized transmission of quality measures data using the QRDA Category I and QRDA Category III formats, we are requiring th at quality measures data submitted via CEHRT for purposes of reporting for PQRS beginning in 2014 be transmitted using the QRDA Category I and QRDA Category III formats. We note that, although we are requiring th at products be able to transmit data using the QRDA Category I a nd III formats, for purposes of reporting PQRS891 quality measures data to CMS, eligible professi onals need only submit da ta via their EHR using 1 (either QRDA Category I or III) of these formats. For those eligible professionals who wish to participate in both PQRS and the EHR Incentive Program using an EHR product that is CEHRT beginning in 2014, we refer readers to Option 2 for the submission of CQMs under the EHR Incentive Program (77 FR 54058). Collection of EHR data via the NwHIN
. The Nationwide Health Information Network (NwHIN) is an initiative developed by the Depa rtment of Health and Human Services that provides for the exchange of healthcare informa tion. Traditionally, CMS has not collected data received via a direct EHR pr oduct through NwHIN, but we would like to encourage this method with EHR-based reporting. However, we strive to encourage the collection of data via the NwHIN and intend to do so when it is technically f easible to do so (as earl y as 2014). Therefore, we solicited public comment on collecting data via an EHR for PQRS via NwHIN. The following is a summary of the comments we received.
Comment : One commenter opposed collection of da ta received via a direct EHR product through the Nationwide Health Information Ne twork (NwHIN). The commenter believes collecting data through NwHIN is premature and believes that development of the NwHIN is necessary prior to collect ing data through the NwHIN. Response : We appreciate the commenter's feedb ack and agree with the commenter. Therefore, we are not finalizi ng any policy to collect data r eceived via a direct EHR product through the NwHIN at this time. (2) Requirements for a Vendor’s EHR Data Submission Vendor Products for 2013 and Beyond Definition of EHR Data Submission Vendors
. The EHR data submission vendor product was a reporting mechanism that was newly establ ished in the CY 2012 Medicare PFS final rule (76 FR 73324). EHR products from an EHR data submission vendor were products that are able892 to receive and transmit clinical quality data ex tracted from an EHR to CMS. We proposed to modify §414.90(b) to define an electronic health record (EHR ) data submission vendor product as “an electronic health record vendor’s product and version that acts as an intermediary to submit data on Physician Quality Reporting System measures on behalf of an eligible professional or group practice” (77 FR 45053). We invited public comment but received no comments on this proposed definition of EHR data submission vendor product. However, we are modifying this definition to indicate that a data submission vendor is not necessarily an EHR product. Rather, ac cording to stakeholder feedback, an EHR data submission vendor is any en tity that is able to receive and transmit to CMS quality measures data ex tracted from an EHR product on behalf of the eligible professional. Therefore, we are modifying§414.90( b) to define an “electronic health record (EHR) data submission vendor” as “an entity th at receives and transmits data on Physician Quality Reporting System measures from an EHR product to CMS.” Qualification process for EHR Data Submission Vendors for 2013 . Please note that the qualification requirements for a vendor’s EHR data submission vendor products for 2013 were established in the CY 2012 Medica re PFS final rule (76 FR 73327). Specifically, we established that a qualification a nd testing process would occur in 2012 to qualify EHR data submission vendor products to submit PQRS quality measures data for reporting periods occurring in CY 2013. Operationally, we were unable to establis h a qualification and testing process in 2012 to qualify EHR data submission vendor products fo r reporting periods o ccurring in CY 2013. Therefore, we proposed to perform, in 2013, the qualification and testing process established in the CY 2012 Medicare PFS final rule (76 FR 73327) that was supposed to occur in 2012 (77 FR 44812). We invited but received no public comme nt on this proposal. Therefore, we are finalizing our proposal to perfor m this qualification and testing process for EHR data submission893 vendor products in 2013. Discontinuation of Qualification Pro cess for EHR Data Submission Vendors . For 2014 and beyond, we proposed to no longer qualify EHR data submission vendor products to use such products under the PQRS for the same reasons we have articulated in our proposal not to continue qualifying direct EHR products (77 FR 44812). Although we w ould still allow EHR data submission vendors to submit test files to th e PQRS and continue to provide support calls, we would no longer require vendors to undergo th is testing process. CMS, however, would no longer post a list of qualified EHR data subm ission vendors on the CMS website. Therefore, eligible professionals would need to work with their respectiv e EHR data submission vendor to determine whether the vendor has undergone any testing with the PQRS and/or whether EHR data submission vendor can produce and transmit the data in the CMS-specified form and

manner. We invited public comment on our proposal to, beginning 2014, not require qualification of EHR data submission vendor products. We al so invited public comment as to whether CMS should continue to require that EHR data s ubmission vendors undergo these self-nomination and qualification processes prior to being authorized to submit quality measure data to CMS on an eligible professional’s behalf for PQRS reporting purposes. We proposed to not continue the qualificati on requirement (that is , no longer propose this process for 2014 and future years of the program) because we felt adequate checks were in place to ensure that an EHR data submission vendor is able to submit quality measures data for the PQRS. For example, to the extent possible, we intend to align with the Medicare EHR Incentive Program for our criteria for sa tisfactory reporting and measures available for reporting under the EHR-based reporting mechanism. The Medicare EHR Incentive Program requires that an eligible professional submit clin ical quality measures using EH R technology certified under the894 program established by the Office of the Na tional Coordinator for Health Information Technology (ONC). We anticipated that the ONC ’s certification process could include testing related to the reporting of the proposed PQRS EHR measures i ndicated in Table 95, since we proposed to align the PQRS EHR-based measures with the measures available for reporting under the EHR Incentive Program. We invited pub lic comment as to whether, in lieu of qualification, CMS should require that direct EHR products that would be used to submit data on PQRS quality measures for a respective reporti ng period be classified as CEHRT under the program established by the ONC. The following is a summary of comments we received regarding our proposals to discontinue the qualification pro cess for EHR data submission ve ndors and/or requiring that a vendor’s EHR product be CEHRT.
Comment : Several commenters supported our propos al to discontinue qualification of EHR data submission vendors. The commenters be lieved that this proposal moves towards our goal of aligning PQRS and the EHR Incentive Program. The commenters also believed discontinuing qualification of EHR data submi ssion vendors helps to encourage use of the EHRbased reporting mechanis m for reporting under PQRS. Response : Based on the comments received and for th e reasons stated previously, we are finalizing our proposal to disc ontinue qualifying EHR data s ubmission vendors beginning in
2014.
Comment : Some commenters opposed our proposal to discontinue qualification of EHR data submission vendors. The commenters believ e that discontinuing qual ification will increase burden on providers, who will have no guide to determine whether an EHR data submission vendor is qualified to report PQ RS measures. One commenter therefore urged CMS to continue to qualify EHR data submission vendors until th e Office of the National Coordinator (ONC) for895 Health Information Technology certification proce ss can be used for PQRS to certify its EHR products in addition to the EHR Incentive Program . Another commenter expressed concern that, should CMS discontinue the quali fication process for EHR data submission vendors, eligible professionals and group practices would simply assu me that their CEHRT are able to submit data on measures under PQRS. Response : We understand that our deci sion to discontinue the qualification process for an EHR data submission vendor’s EHR products puts the onus on eligible professionals and group practices to determine whether a product meets the requirements for reporting PQRS measures. However, we have received much stakeholder feedback requested that we discontinue the requirement that an eligible professional select a "qualified" EHR product; the stakeholders believe that the qualified designation is confus ing, because there is already a certification program in place established by ONC that tests and certifies certain EHR products. Therefore, we are finalizing our decision to discontinue the qualification pr ocess for EHR data submission vendor’s EHR products under the PQRS beginning in 2014. Nonetheless, we share the commenter's c oncern that discontinuing the qualification process would place additional burden on providers when trying to determine which EHR data submission vendor to enter into an agreement wit h. Therefore, based on the comments received and for the reasons we are requiring that dir ect EHR products be CEHRT beginning in 2014, we are also finalizing a requirement that a ve ndors EHR product be certified under the program established by ONC as Certified EHR Technology (C EHRT), and therefore meet the definition of CEHRT in ONC’s regulations (see 45 CF R 170.102), to submit PQRS measures. We understand that CEHRT may provide more capabili ties than needed to report PQRS quality measures. However, we note that most of th ese capabilities are inte rtwined with the EHR product’s ability to capture data on qual ity measures and therefore necessary.896

Comment : While one commenter generally su pported requiring that EHR data submission vendor products be ONC certified as CEHRT to report PQRS measures, the commenter stated that the ONC certification proc ess should only be used for the PQRS and EHR Incentive Programs if the measures are identical, particularly in specifications and reporting format. Response : We note the commenter's concern rega rding use of the ONC certification process and the alignment of EHR-based measur es in PQRS and the EHR Incentive Program. As we noted in the response to this comm ent regarding requiring CEHRT and direct EHR products, it is our intention to align, to the maxi mum extent possible, th e measures and reporting criteria for eligible professionals to meet the criteria for satisfactory re porting under PQRS and the criteria for meeting the CQM component of meaningful use under the EHR Incentive Program. By 2014, we expect that the measures and reporting criteria available under both programs will be sufficiently aligned to justify requiring that an EHR product undergo the ONC certification process. Therefore, we believe that re quiring a direct EHR pr oduct to be CEHRT in order to be eligible to report measures under PQRS beginning in 2014 is appropriate. Other Requirements for Data Submission Vendors’ EHR Products . Although EHR data submission vendor products are no longer be requ ired beginning in 2013 to undergo this testing or qualification process, we pr oposed that CMS would only accept the data if the data are:

● Transmitted in a CMS-approved XML fo rmat utilizing a Clinical Document Architecture (CDA) standard such as Quality Re porting Data Architecture (QRDA) level 1 and for EHR data submission vendor products that intend to report for purpos es of the proposedPQRS-Medicare EHR Incentive Program Pilot, if the aggregate data are transmitted in a CMSapproved XML format

● In compliance with a CMS-specified s ecure method for data submission (77 FR897 44812). In addition, upon request and for oversight pu rposes, we proposed that the vendor would still be expected to provide CMS access to review the Medicare beneficiary data on which PQRS direct EHR-based submissions are founded or pr ovide to CMS a copy of the actual data. We invited public comment on these proposed requirements for EHR data submission vendors. The following is a summary of the comments we received on this proposal.
Comment : One commenter generally supported our proposal to require that data submitted follow the proposed format, regardless of whether the qualification process is discontinued. The commenter also specifically su pported use of a standard reporting structure in XML. The commenter further believes that QR DA Level 1 should adequately capture measure information for patients and types of measures wh ere the analysis is something other than the patient. Response : We appreciate the commenter's supp ort and are finalizing these proposed requirements, as proposed. In addition, we note that in addition to fina lizing the submission of quality measures data using the QRDA Category I format, the EHR Incentive Program also finalized the QRDA Category III transmission format (77 FR 54075). In our proposal, we proposed to require that eligible professionals and group practices usi ng CEHRT transmit quality measures data in a CMS-approved XML format utilizing a Clinical Document Architecture (CDA) standard, and used QRDA Category I as an example. Since it was our intent to align with the EHR Incentive Program, who finalized transmission of quality measures data using the QRDA Category I and QRDA Category III formats, we are also requir ing that quality measures data submitted via CEHRT for purposes of reporting for PQRS be ginning in 2014 be transmitted using the QRDA Category I and QRDA Category II I formats. We note that, although we are requiring that898 products be able to transmit data using the QRDA Category I and III formats, for purposes of reporting PQRS quality measures data to CMS, eligible professionals need only submit data via their EHR using 1 (either QRDA Category I or II I) of these formats. For those eligible professionals who wish to participate in both PQRS and the EHR Incentive Program using an EHR product that is CEHRT beginning in 2014, we refer readers to Option 2 for the submission of CQMs under the EHR Incentive Program (77 FR 54058). Collection of EHR Data via the NwHIN . The Nationwide Health Information Network (NwHIN) is an initiative developed by the Depa rtment of Health and Human Services that provides for the exchange of healthcare informa tion. Traditionally, CMS has not collected data received via an EHR data submission vendor through NwHIN, but we would like to encourage this method with EHR-based reporting. However, we strive to encourage the collection of data via the NwHIN and intend to do so when it is tech nically feasible to do so (as early as 2014). Therefore, we solicited public comment on collec ting data via an EHR for PQRS via NwHIN. The following is a summary of comments we received.
Comment : One commenter opposed collection data received via a direct EHR product through the Nationwide Health Information Ne twork (NwHIN). The commenter believes collecting data through NwHIN is premature and believes that development of the NwHIN is necessary prior to collect ing data through the NwHIN. Response : We appreciate the commenter's feedb ack and agree with the commenter. Therefore, we are not finalizing any plan to co llect data received via an EHR data submission vendor through the NwHIN at this time. d. GPRO Web interface: Requirements for Gr oup Practices Using the GPRO Web interface for 2013 and Beyond899

The GPRO web interface is a reporting mechanism establishe d by CMS that is used by group practices that are selected to particip ate in the GPRO. For 2013 and beyond, we proposed to modify newly designated §414.90(g) and §414.90(h) to identify the GPRO web interface as a reporting mechanism available for reporting under the PQRS by group practices comprised of 25 or more eligible professionals (77 FR 45055). Consistent with the GP RO satisfactory reporting criteria we established for the 2012 PQRS ( 76 FR 73338), as well as the GPRO satisfactory reporting criteria we proposed for 2013 and beyond, we proposed to limit reporting via the GPRO web interface during a respec tive reporting period to group pract ices composed of at least 25 eligible professionals (that is , this reporting option would not be available to group practices that contain 2-24 eligible professionals) and sel ected to participate in the GPRO for the year under which the reporting period occurs (77 FR 44812). For example, a group practice wishing to submit quality measure data via the GPRO web interface for 2013 must be a group practice selected to participate in the GP RO for the 2013 program year. We believe it is necessary to limit use of the GPRO web interface to group practices comprised of at least 25 eligible professionals selected to participate in the GPRO because the 18 measures (including 2 composite measures, for a total of 22 measures) that are proposed to be reportable via the GPRO web interface (as specified in Table 33 of the propos ed rule) reflect a variety of di sease modules: patient/ caregiver experience, care coordination/pati ent safety, preventive health, di abetes, hypertension, ischemic vascular disease, heart failure, a nd coronary artery disease.
We believe that the reporting of the 18 proposed measures spanning across various settings would lend this reporting mechanism to larg er group practices that are more likely to be multi-specialty practices (which ar e typically group practices consisting of more than 24 eligible professionals). The GPRO web interface was modeled after the CMS Physician Group Practice (PGP) demonstration, and this de monstration was originally inte nded for large group practices.900 From our experience with the PGP demonstration, we believe a group practice comprised of 25 eligible professionals is the sm allest group practice that could be nefit from use of the GPRO web interface as a reporting mechanis m. We also do not believe that excluding group practices comprised of 2-24 eligible professionals from using the GPRO web interface as a reporting mechanism would harm these smaller group prac tices because we proposed to expand the reporting options for small group practices by pr oposing to allow groups composed of 2-99 eligible professionals to report using the clai ms, qualified registry, EHR, and administrative claims-based reporting mechanisms. We proposed to provide group practices that are selected to participate in the GPRO using GPRO web interface reporting option with access to the GPRO we b interface by no later than the first quarter of the year following th e end of the reporting period under which the group practice intends to report (77 FR 44813). For example, for group practices selected for the GPRO for the 2013 incentive using the GPRO web interface tool, we proposed to provide group practices selected to particip ate in the GPRO with access to the GPRO web in terface by no later than the first quarter of 2014 for purposes of re porting for the applicab le 2013 reporting period for the incentive. In addition, we noted that if CMS encountered operational issues with the use of the GPRO web interface, we re served the right to use a simila r tool for group practices to use in lieu of reporting via th e GPRO web interface. We invited public comment on our proposed requirements for group practices using the GPRO web interface for 2013 and beyond. We received the following comment on these proposals:
Comment : One commenter supported our proposal to limit availability of the GPRO web interface to group practices of 25 or more eligible professi onals and agreed with our reasoning.901
Response : We appreciate with the commenter's fee dback and, therefore, we are finalizing our proposal to limit the availabil ity of the GPRO web interface to group practices comprised of 25 or more eligible professionals. In the futu re, CMS will try to develop ways by which smaller group practices could be able to use the GPRO web interface. Based on the comments received, we are fina lizing, as proposed, requirements for group practices using the GPRO web interface fo r 2013 and beyond. We are also modifying §414.90(g)(3) and §414.90(h)(3) to indicate that th e GPRO web interface will be a reporting mechanism available for use by group practi ces for the PQRS incentives and payment adjustments. Collection of GPRO Web in terface Data via the NwHIN . The Nationwide Health Information Network (NwHIN) is an initiative developed by the Department of Health and Human Services that provides for the exchange of healthcare information. Traditionally, CMS has not collected data received via the GP RO web interface through NwHIN. However, we strive to encourage the collec tion of data via the NwHIN and intend to do so when it is technically feasible to do so (as early as 2014). Therefore, we solicited public comment on collecting data via the GPRO web interface fo r PQRS via NwHIN. We received no public comment on this proposal. However, since we believe collecting data via the NwHIN would be premature, we are not finalizing any policy to co llect data received via the GPRO web interface in the NwHIN. e. Administrative Claims For purposes of reporting for the 2015 and 2016 PQRS payment adjustments only, we proposed to modify §414.90(h) to allow eligible professionals and group practices to use an administrative claims reporting mechanism (77 FR 45056). The administrative claims reporting mechanism builds off of the traditional PQRS claims-based reporting mechanism. Under the902 traditional PQRS claims-based reporting mechanism, eligible professionals and group practices wishing to report data on PQRS quality measures via claims for the incentives and for the payment adjustments must submit quality data co des (QDCs) on claims to CMS for analysis. Under the proposed administrative claims repor ting mechanism, unlike th e traditional claimsbased reporting option, an eligible professional or group practice would not be required to submit QDCs on claims to CMS for analysis (77 FR 44813) . Rather, CMS would analyze every eligible professional’s or group practice’s patient’s Medicare claims to de termine whether the eligible professional or group practice has pe rformed any of the clinical qua lity actions indicated in the proposed PQRS quality measures in Table 63 of the CY 2013 PFS proposed rule. We proposed that, for purposes of assessing claims for quali ty measures under this option, all claims for services furnished that occur during the 2015 and/or 2016 PQRS payment adjustment reporting period would need to be processed by no later than 60 days after the end of the respective 2015 and 2016 payment adjustment reporting periods (that is, December 31, 2013 and December 31, 2014). We invited public comment on our proposed requirements for using the administrative claims-based reporting mechanism for the 2015 and 2016 payment adjustments. The following is summary of the comments we re ceived regarding these proposals.
Comment : Several commenters supported the additi on of the administrative claims-based reporting mechanism for the 2015 and 2016 PQRS payment adjustments. The commenters noted that this addition of the administrative clai ms-based reporting mechanism would relieve the reporting burden on eligible professionals. Response : We appreciate the commenters' feedback and are finalizing the administrative claims-based reporting mechanism for the 2015 paym ent adjustment. Since it is our intention that this reporting option be temporary, we will consider having the administrative claims-based903 reporting mechanism available for the 2016 PQRS pa yment adjustment in the future, but we are not finalizing our proposal to have the administ rative claims-based reporting option for eligible professionals and group practices for the 2016 PQRS payment adjustment at this time. As participation in PQRS increases and eligible professionals an d group practices become more familiar with the traditional claims, registry, di rect EHR, EHR data submission vendor-based, or GPRO web interface reporting mechanisms, it is our intention to move away from use of the administrative claims-based reporting mechanis m to allow for more proactive reporting by eligible professionals and group practices.
Comment : One commenter suggested that eligible professionals be allowed to choose the administrative claims-based reporting option to meet the criteria for satisfactory reporting for the 2013 and 2014 PQRS incentives. Response : We respectfully disagree. We believe that eligible prof essionals and group practices should be required to use the traditional re porting mechanisms (claims, registry, EHR, or GPRO web interface) to repor t for the PQRS incentive as we believe that reporting via these traditional reporting mechanisms produce more meani ngful data. As noted previously, while the administrative claims-based reporting mechanism still satisfies PQRS requirements by submitting quality measures data to CMS, we agree with other commenters that the administrative claims-based reporting option may not provide data that is as meaningful as data collected through other mechanisms . We are finalizing the additi on of the administrative claimsbased reporting option only as a means to repo rt for the 2015 PQRS payment adjustments to ease eligible professionals into re porting PQRS measures. Since we see this option as temporary, only a limited set of measures were proposed for use under the administrative claims-based reporting option. We believe that more meaningful data will be collected using the traditional claims, registry, EHR, or GPRO web inte rface reporting mechanisms, where eligible904 professionals or group practices may choose meas ures from a broad set that may be more relevant to their practice. Therefore, eligible professionals will not be able to use the administrative claims-based reporting mech anism for the 2013 and 2014 PQRS incentives. Based on the comments received, we are fi nalizing, as proposed, the administrative claims-based reporting mechanism for reporting for the 2015 payment adjustment only. We are not finalizing the administrative claims-based reporting mechanism for the 2016 PQRS payment adjustment, as we will revisit the necessity of having this reporting option available for the 2016 PQRS payment adjustment next year. We are modifying §414.90(h)(2) and §414.90(h)(3) to indicate that the administrative claims-based repo rting mechanism is available for use by eligible professionals and group practices fo r the 2015 PQRS payment adjustment. 4. Criteria for Satisfactory Reporting for the 2013 and 2014 Incentives For 2013 and 2014, in accordance with §414.90(c )(3), eligible pr ofessionals that satisfactorily report data on PQRS quality measures are eligible to receive an incentive equal to 0.5 percent of the total estimated Medicare Part B allowed charge s for all covered professional services furnished by the eligib le professional or group practice during the applicable reporting period. This section contai ns the criteria for satisfact ory reporting for the 2013 and 2014 incentives, which are the last two incen tives authorized under the PQRS. a. Criteria for Satisfactory Reporting for Individual Eligible Professionals (1) Criteria for Satisfactory Reporting on I ndividual PQRS Quality Measures via Claims According to the “2010 Physician Qual ity Reporting System and eRx Reporting Experience and Trends,” availabl e for viewing in the “downloads” section of the main page the PQRS website ( http://www.cms.gov/Medicare/Qualit y-Initiatives-Patient-AssessmentInstruments/PQRS/index.html ), reporting via the claims-based reporting mechanism was the most commonly used reporting method. We believe that this trend w ould continue, so we905 anticipated that, for the 2013 and 2014 incentives, the criteria for satisfa ctory reporting for the claims-based reporting mechanism would be the me thod most widely used by individual eligible professionals. So as not to ch ange reporting criteria that a la rge number of individual eligible professionals are familiar with using, we establ ished the same reporting criteria for the 2011 and 2012 incentives (76 FR 73330). Therefore, for th e respective 12-month reporting periods for the 2013 and 2014 incentives, based on our authorit y under section 1848(m)(3)(D) of the Act to revise the reporting criteria for satisfactory reporting specified under the statute and our desire to maintain the same reporting criteria we establishe d for individual eligible professionals for the 2012 PQRS incentive (76 FR 73330), we proposed the following criteria for satisfactory reporting of PQRS individual measures for indivi dual eligible professiona ls using the claimsbased reporting mechanism: Report at least 3 meas ures, OR, if less than 3 measures apply to the eligible professional, report 1—2 measures, AND re port each measure for at least 50 percent of the eligible professional’s Me dicare Part B FFS patients seen during the reporting period to which the measure applies (77 FR 44813). Measur es with a 0 percent pe rformance rate would not be counted. For an eligible professional w ho reports fewer than 3 measures via the claimsbased reporting mechanism, we proposed that the eligible professiona l be subject to the Measures Applicability Validation (MAV) process, which would allow us to determine whether an eligible professional should ha ve reported quality data codes fo r additional measures. We felt the MAV process was necessary to review whether there are other closely related measures (such as those that share a common diagnosis or those that are representative of services typically provided by a particular type of e ligible professional). Under the MAV process, if an eligible professional who reports on fewer than 3 measures reports on a measure that is part of an identified cluster of closely related measures, then the eligible professional would not qualify as a satisfactory reporter for the 2013 and/or 2014 in centives. We proposed this MAV process for906 the claims-based reporting mechanism only becaus e it is more likely for EPs to report on more than 3 measures under the registry and EHR-base d reporting mechanisms, as a registry or EHR product will typically automatical ly report on all measures th at apply to the eligible professional’s practice. We note that, consistent with section 1848(m)(3)(A )(i) of the Act, this proposed claims-based reporting crit eria would be the only proposed criteria where an eligible professional could report on fewer than 3 measures. We invited public comment on the proposed criteria for satisfactory reporting of individual measures by individual eligible professionals via claims for the 2013 and 2014 incentives. The following is a summary of the comment we received regarding these proposed criteria:
Comment : One commenter supported our proposed cr iteria for satisfactory reporting for individual eligible professionals via claims. The commenter stated that the 3-measure threshold allows small practices that participate individually treating multi-morbid patients to participate in PQRS. Response : Based on the comments received and for th e reasons stated previously, we are finalizing, as proposed, the criteria for satisfactory reporting for i ndividual eligible professionals via claims for the 2013 and 2014 PQRS incentives. These criteria are specified in Tables 25 and 26 below. (2) Criteria for Satisfactory Reporting on Indi vidual PQRS Quality Measures via Registry We note that section 1848(m)(3)(A )(ii) of the Act provides that , to meet the criteria for satisfactory reporting under PQRS, an eligible professional would be required to report on at least 3 measures for at least 80 percent of the cas es in which the respective measure is reportable under the system. Although we have the author ity under section 1848(m)(3)(D) of the Act to revise the criteria for satisfactory reporting, for registry -based reporting, we have largely907 followed these reporting criteria for the PQRS incentives. According to the “2010 Physician Quality Reporting System and eRx Reporting Experience and Trends,” eligible professionals are more likely to meet the requirements for a PQ RS incentive using th e satisfactory reporting criteria for the registry-based reporting mechanism than claims. In fact, in 2010, approximately 87 percent of the eligible professionals reporti ng individual PQRS quality measures via registry were eligible and met the criteria for satisfact ory reporting for the 2010 incentive. Since eligible professionals have had success with using these satisfactory reporting criteria, we believe such criteria are appropriate and see no reason to change the criteria for satisfactory reporting via registry that has been in pl ace since 2010. Therefore, for those reasons and our desire to maintain the same reporting criteria we establishe d for individual eligible professionals for the 2012 PQRS incentive (76 FR 73331), we proposed the following criteria for satisfactory reporting of PQRS individual measures for indivi dual eligible profession als using the registrybased reporting mechanism for the 12-month re porting periods for the 2013 and 2014 incentives, respectively: report at least 3 measures AND repor t each measure for at least 80 percent of the eligible professional’s Medicare Part B FFS patients seen during the reporting period to which the measure applies (77 FR 44814). Measures with a zero percent perfor mance rate will not be counted. We invited but received no public comment on the proposed criteria for satisfactory reporting of individual measures by individual eligible professi onals via a registry for the 2013 and 2014 incentives. Therefore, we are finalizing these criteria as proposed. These criteria are specified in Tables 25 and 26 below. (3) Criteria for Satisfactory Reporting on Individual PQRS Quality Measures via EHR Satisfactory Reporting Criteria of Individua l PQRS Quality Measures via EHR for the 2013 PQRS Incentive . As stated previously, section 1848(m)(7) of the Act requires us to908 develop a plan to integrate re porting requirements for PQRS and the EHR Incentive Program. Therefore, for EHR-based reporti ng, it is our main goal to ali gn our EHR reporting requirements with the reporting requirements an eligible profes sional must meet to satisfy the clinical quality measure (CQM) component of meaningful use (MU) under the EHR Incentive Program. To align with the EHR Incentive Program, we base d our proposals on the EHR Incentive Program – Stage 2 NPRM (77 FR 13698). Also to align with the EHR Incentive Program, for the EHR reporting periods in CY 2013, we proposed ( 77 FR 13745) to continue the CQM reporting requirements that were established for eligib le professionals for CYs 2011 and 2012 in the EHR Incentive Program – Stage 1 final rule (75 FR 44398-44411). Therefore, to align with the reporting requirements for meeting the CQM com ponent of meaningful use, and based on our authority under section 1848(m)(3)(D ) of the Act to revise the re porting criteria for satisfactory reporting identified under the statute, we pr oposed the following criteria for the 12-month reporting period for the 2013 incentive (77 FR 44814):

● As required by the Stage 1 final rule, el igible professionals must report on three Medicare EHR Incentive Program core or alternate core measures, plus three additional measures. The EHR Incentive Program’s core, alte rnate core, and additional measures can be found in Table 6 of the EHR Incentive Program’s Stage 1 final rule (75 FR 44398) or in Tables 32 and 33 of the CY 2013 PFS proposed rule. We refe rred readers to the discussion in the Stage 1 final rule for further explanation of the re quirements for reporti ng those CQMs (75 FR 44398 through 44411). Under this proposal, eligible professionals using these reporting criteria would be required to report on 6 measures. For the proposed PQRS EHR measures th at are also Medicare EHR Incentive Program core, alternate core, or a dditional measures that the eligible professional reports (75 FR 44398 through 44411), an eligible pr ofessional would be re quired to report the909 applicable measure for 100 percent of the eligible professionals Me dicare Part B FFS patients. In addition, we noted that section 1848(m)(3)(A )(ii) of the Act provide s that, to meet the criteria for satisfactory reporti ng under PQRS, an eligible prof essional would be required to report on at least 3 measures for at least 80 percent of the cases in which the respective measure is reportable under the system. Although we ha ve the authority under section 1848(m)(3)(D) of the Act to revise the criteria for satisfactory reporting, for EHR-based reporting, we noted that we have largely kept these re porting criteria for the 2010—2012 incen tives. As some eligible professionals succeeded with thes e criteria, we proposed the follo wing similar criteria for the 12-month reporting period for the 2013 incentive: re port at least 3 measures AND report each measure for at least 80 percent of the eligible professional’s Medicare Part B FFS patients seen during the reporting period to which the measure applies (77 FR 44814). Measures with a zero percent performance rate will not be counted. We received no public comment on the satisf actory reporting criterion we proposed for individual PQRS measures using a direct EH R or EHR data submission vendor product for the 2013 PQRS incentive: Report at least 3 measures for at least 80 percent of the cases in which the respective measure is reportable under the system. Therefore, for the reasons previously stated, we are finalizing the criterion. We invited public comment on the proposed cr iteria for the satisfactory reporting of individual PQRS measures using a direct EH R or EHR data submission vendor product for the 2013 PQRS incentive. The following is a summary of those comments.
Comment : Several commenters generally support ed our proposals to align the EHR reporting criteria with the criteria establis hed for meeting the CQM component of achieving meaningful use under the EHR Incentive Program. Response : We appreciate the commenters’ positive feedback.910

Comment : Several commenters supported our proposed criteria for the satisfactory reporting of PQRS measures vi a direct EHR or EHR data s ubmission vendor products for the 2013 PQRS incentive, as the proposed criteria ali gns with the CQM criteria of meaningful use for the EHR Incentive Program. Response : We appreciate the commenters' feedbac k. Based on the support received for this proposed criterion and for the reasons we discussed above, we are finalizing the following criterion for the satisfactory repor ting of individual PQRS measur es using a direct EHR or EHR data submission vendor product for the 2013 PQRS incentive: As required by the Stage 1 final rule, eligible professionals must report on three Medicare EHR Incentive Program core or alternate core measures, plus three additional measures. The EHR Incentive Program’s core, alternate core, and additional measures can be found in Tables 6 and 7 of the EHR Incentive Program’s Stage 1 final rule (75 FR 44398 throug h 44411) or in Table 95 of this section. We refer readers to the discussion in the Stage 1 fina l rule for further explanation of the requirements for reporting those CQMs (75 FR 44398 through 44411).
Comment : Several commenters encouraged us to accept the reporting of measures with a zero percent performance rate using the EHR-based satisfactory reporting criter ia that aligns with the EHR Incentive Program. Under Stage 1, many of the core and alternate core measures are not applicable to specialties. The commenter be lieves that allowing the reporting of measures with a zero percent performance rate will achieve our goal of having eligible professionals report one set of data for PQRS and the EHR Incentive Program. Response : We understand the commenter's concerns. We have stressed the importance of collecting data that is applicable to the eligible professional’s practice. Therefore, or PQRS, we are only concerned with the reportin g of measures that are relevant to an eligible professional’s practice. An eligible professi onal may still report on the same number of measures he/she is911 reporting for the EHR Incentive Program. Howeve r, for purposes of PQRS, we will only analyze the measures that are applicable to the eligible professional’s practice. If using this reporting criterion, an eligible professional should be able to report on at least one applicable measure. Satisfactory Reporting Criteria of Individua l PQRS Quality Measures via EHR for the 2014 PQRS Incentive . At the time of the CY 2013 PFS pr oposed rule, we noted that we had proposed under the Medicare EH R Incentive Program options fo r meeting the CQM component of achieving meaningful us e beginning with CY 2014 ( 77 FR 13746—13748). To align our EHR-based reporting requirements with those proposed under the Medicare EHR Incentive Program, we proposed the following criteria fo r satisfactory reporting using the EHR-based reporting mechanism for the 12-month re porting period for the 2014 incentive:

● Option 1a: Select and submit 12 clinical quality measures avai lable for EHR-based reporting from Tables 32 and 33 of the proposed ru le, including at least 1 measure from each of the following 6 domains – (1) patient and fam ily engagement, (2) patient safety, (3) care coordination, (4) population and public health, (5) efficient use of healthcare resources, and (6) clinical process/effectiveness.

● Option 1b: Submit 12 clinical quality meas ures composed of all 11 of the proposed Medicare EHR Incentive Program core clinical qua lity measures specified in Table 95 plus 1 menu clinical quality measure from Tables 32 an d 33 of the proposed rule. We noted it was our intention to finalize the reporting cr iteria that aligns with the crit eria that would be established for meeting the CQM component of meaningful use beginning with CY 2014 for the Medicare EHR Incentive Program. Furthermore, to the exte nt that the final criteria for meeting the CQM component of achieving meaningful use differ from what was proposed, we noted that our intention was to align with the reporting criteria the EHR Incentive Program ultimately established (77 FR 44814). Theref ore, eligible professionals who participate in both PQRS and912 the EHR Incentive Program would be able to use one reporting criter ion, during overlapping reporting periods, to satisfy the satisfactor y reporting criteria unde r PQRS and the CQM component of meaningful use under th e Medicare EHR Incentive Program. In addition to this proposed criterio n, we had proposed under the Medicare EHR Incentive Program that, beginning with CY 2014, e ligible professionals who participate in both the Physician Quality Reporting System and the Medicare EHR Incentive Program may satisfy the CQM component of meaningful use if they submit and satisf actorily report PQRS clinical quality measures under the PQRS EHR reportin g option using Certified EHR Technology (77 FR 13748). Since this language s uggested that the Medicare EH R Incentive Program may defer to the satisfactory reporting criteria for the EHR-based reporting mechanism that we will establish for 2014, we proposed the following re porting criteria for the 12-month reporting period for the 2014 incentive that largely conform to the criter ia set forth under section 1848(m)(3)(A)(ii) of the Act that we established for the 2012 incentive and that we proposed for the 2013 incentive: report at least 3 measures AND report each measure for at least 80 percent of the eligible professional’s Me dicare Part B FFS patients seen during the reporting period to which the measure applies. Measures with a zero percent performance rate will not be counted. We received no comments regarding the followi ng proposed criteria using a direct EHR or EHR data submission vendor product for the 2014 incentive: Report at least 3 measures AND report each measure for at least 80 percent of the eligible prof essional’s Medicare Part B FFS patients seen during the reporting pe riod to which the measure applies. However, in an effort to streamline reporting requirements for the 2014 PQRS incentives, we only wish to finalize one reporting criterion to meet the criteria for satisfactory report ing for the 2014 PQRS incentive using an EHR-based reporting mechanism. Ther efore, since the EHR Incentive Program did not finalize this proposed reporting cr iterion, we are not finalizing this proposed criterion. We913 understand that not finalizing th is criterion would eliminate a reporting option previously available to eligible professi onals. We note however, that th is EHR-based reporting criterion was not widely used by eligible professionals. In fact, according to the 2010 PQRS and eRx Experience Report, less than 1% of eligible professionals particip ating in PQRS did so using the EHR-based reporting mechanism. Therefore, we do not believe eligible professionals will be harmed by our decision not to fina lize this criterion. Furthermor e, we believe that eligible professionals that have used the EHR-based re porting mechanism in the past will gravitate towards using reporting criteri on that aligns with the EHR Incentive Program, as eligible professionals using aligned criterion will have th e ability to submit one set of quality measures data to achieve the requirements under bot h PQRS and the EHR Incentive Program. Nonetheless, we are streamlining the criteria in 2014, and not 2013, in order to give eligible professionals an additional year to adjust their practice workflows to account for this change. We invited public comment on the proposed cr iteria for satisfactory reporting on PQRS measures via EHR for the 2014 PQRS incentive th at were proposed under the EHR Incentive Program for 2014. The following is summary of the comments we received regarding these proposals.
Comment : Several commenters generally support ed our proposals to align the EHR reporting criteria with the criteria establis hed for meeting the CQM component of achieving meaningful use under the EHR Incentive Program. Response : We appreciate the commenters’ positive feedback.
Comment : Some commenters suggested an alternative criterion for the satisfactory reporting of individual PQRS measures via EHR: For the 2014 PQRS incentive, report six measures, covering at least two domains. If no individual measures available for EHR-based914 reporting are relevant to the elig ible professional, the eligible professional may submit measures with a zero percent performance rate. Response : We appreciate the commenter's suggesti on. However, as previously stated, it is our intention to adopt satisfa ctory reporting criteria that closely aligns with the criteria established for achieving meani ngful use for the EHR Incentive Program. Since the alternative criterion proposed by the commenter does not a lign with the criteria established for the EHR Incentive Program, we respectfully decline to establish this alternative criterion for the satisfactory reporting of indi vidual measures via EHR for the 2014 PQRS incentive.
Comment : For the proposed option 1a for EH R-based reporting for the 2014 PQRS incentive, one commenter believed that the re quirement to report 12 CQMs is too high. The commenter believed that because many measures are focused towards primary care and preventive medicine, it may be difficult for s ub-specialists to meet the 12 CQM threshold, leading these eligible professionals to potentially report a zero percent pe rformance rate on most measures. Commenters were also concerned that the proposal to report atleast 1 measure from each of the six proposed domains would add to di fficulty in reporting, as some of the domains have limited measure sets. Response : We understand and agree with the comme nter's arguments against option 1a. Indeed, the EHR Incentive Program did not finali ze these criteria for reporting CQMs to achieve meaningful use under the EHR Incen tive Program. Therefore, we are not finalizing this proposal for the PQRS.
Comment : For the proposed option 1b for EH R-based reporting for the 2014 PQRS incentive, one commenter believed that the requi rement to report 12 CQMs is too high. Because many measures are focused towards primary care and preventive medicine, the commenter was concerned that it may be difficult for sub-specia lists to meet the 12 CQM threshold, leading these915 eligible professionals to potentially report a zer o percent performance rate on most measures. Commenters also believed that the additional proposed requirement to reporting on 11 core CQM measures may have the nega tive consequence of forcing elig ible professionals to report on measures that are not fully relevant to their respective practice, as there may not be 12 CQMs relevant to their practice. Response : We understand and agree with the comme nter's arguments against option 1b. Indeed, the EHR Incentive Program did not finali ze these criteria for reporting CQMs to achieve meaningful use under the EHR Incen tive Program. Therefore, we are not finalizing this proposal for the PQRS.
Comment : Several commenters encouraged us to accept the reporting of measures with a zero percent performance rate using the EHR-based satisfactory reporting criter ia that aligns with the EHR Incentive Program. The commenter believ es that allowing the reporting of measures with a zero percent performance rate will achieve our goal of having eligible professionals report one set of data for PQRS and the EHR Incentive Program. Response : We understand the commenter's concerns . For PQRS, we are only concerned with the reporting of measures that are relevant to an eligible pr ofessional’s practice. Therefore, we will only analyze the measures for which there is Medicare patient data. We note that, despite this distinction in the way the eligible professional’s submitted data is analyzed, we are still achieving our goal of a ligning the criteria for sati sfactory reporting under PQRS with the criteria for m eeting the CQM component of achi eving meaningful use under the EHR Incentive Program. Eligible professionals will st ill be able to report the same set of data in the same form and manner to sa tisfy the requirements for both programs. The only distinction lies in the analysis performed by the two programs. For example, let’s pretend an eligible professional, in 2014, uses CEHRT to report 9 m easures covering 3 domai ns, and only 1 measure916 applies to the eligible professional’s practice (tha t is, the eligible professional has patients that are eligible for inclusion in only 1 measure’s denominator). The eligible professional will have met the criteria for meeting the CQM component of achieving meaningf ul use in 2014, because the eligible professional would have reported 9 measures covering at least 3 domains and reported the measures (1 measure, in this exam ple) for which there is patient data and the remaining required measures as "zero denominator s" as displayed by the eligible professional's CEHRT. The eligible professional will have also met the criteria for satisfactory reporting under PQRS for the 2014 PQRS incentive, because we w ill assume that by receiving data for only 1 measure with a denominator greater than zero th at the eligible professional did not have any other applicable measures on which to report.. We understand that there may be instances where no measures apply to an eligible professional. For those eligible professionals for which no measur es available for reporting used the EHR-based reporting mechanisms apply, fo r 2014, we strongly encour age those eligible professionals to meet the criteria for satisfact ory reporting using an al ternative reporting option.

Based on the comments received and for the reasons we stated above, we are finalizing the following criteria for satisfa ctory reporting of indi vidual PQRS measures using direct EHR or EHR data submission vendor products fo r the 2014 PQRS incentive: Report 9 measures covering at least 3 domains, as specified in Tabl e 95. If an eligible professional's CEHRT does not contain patient data for at least 9 measures covering at least 3 domains, then the eligible professional must report the measures for which there is patient data. We note that the EHR Incentive Program established the requirements, should an eligible professional’s CEHRT not contain patient data for at least 9 measures covering at least 3 domains, the eligible professional must report the measures for which there is patient data and917 report the remaining required measures as "zer o denominators" as displayed by the eligible professional's CEHRT. If there are no measures a pplicable to the eligible professional's scope of practice and patient population, eligib le professionals must still repor t 9 measures even if zero is the result in either the numerator or denominator of the measure. If all applicable measures have a value of zero from their CEHRT, then eligible professional must report any 9 measures (77 FR 54058). For PQRS, we are only concerned with the re porting of measures that are relevant to an eligible professional’s practice. Therefore, we are not accepting th e reporting of “zero denominators.” Therefore, to meet the crit eria for satisfactory re porting for the 2014 PQRS incentive using this criterion, an eligible pr ofessional must report on at least 1 applicable measure (that is, at least 1 of the 9 measures th at the eligible professi onal reports using an EHRbased reporting mechanism must not have a “zero denominator”) . (4) Criteria for Satisfactory Reporti ng on PQRS Measures Groups via Claims In the CY 2012 Medicare PFS final rule, we established the following criteria for satisfactorily reporting PQRS measures groups for the 12-month reporting period for the 2012 incentive (76 FR 73335):

● Report at least 1 PQRS measures group, AND report each measures group for at least 30 Medicare Part B FFS patients. Measures gr oups containing a measure with a 0 percent performance rate will not be counted; OR

● Report at least 1 PQRS measures group, AND report each measures group for at least 50 percent of the eligible prof essional’s Medicare Part B FFS pa tients seen during the reporting period to whom the measures group applies; BUT report each measures group on no less than 15 Medicare Part B FFS patients seen during the re porting period to which the measures group applies. Measures groups containing a measure with a 0 percent performance rate will not be counted.918

We received stakeholder feedback that it is difficult for some specialties to meet the 30 Medicare Part B FFS patient threshold. Ther efore, based on our authority under section 1848(m)(3)(D) of the Act to revise the reporting criteria for sa tisfactory reporting, we proposed the following criteria for the satisfactorily re porting PQRS measures groups for individual eligible professionals using the claims-based reporting mechanism for the 12-month reporting periods for the 2013 and 2014 incentives: Report at least 1 measures group AND report each measures group for at least 20 Medicare Part B FFS patients. Measur es groups containing a measure with a zero percent performance ra te will not be counted (77 FR 44815). We invited public comment on the proposed criterion for satisfactory reporting of measures groups via claims for the 2013 and 2014 in centives. The following is summary of the comments we received regarding this proposal.
Comment : Several commenters supported our pr oposal to lower the minimum patient count for reporting measures groups from 30 to 20. Commenters noted that lowering the reporting threshold would ease th e reporting burden of reporting measures groups for eligible professionals. Response : We appreciate the commenters' fee dback and are finalizing our proposed criteria for individual eligible professionals reporting measures groups via claims for the 2013 and 2014 PQRS incentives. The criteria are specified in Tables 25 and 26 below. (5) Criteria for Satisfactory Reporting on PQRS Measures Groups via Registry In the CY 2012 Medicare PFS final rule, we established the following criteria for satisfactorily reporting PQRS measures groups for the 12-month reporting period for the 2012 incentive (76 FR 73337):

● Report at least 1 PQRS measures group AND report each measures group for at least 30 Medicare Part B FFS patients. Measures gr oups containing a measure with a 0 percent919 performance rate will not be counted; OR

● Report at least 1 PQRS measures group, AND report each measures group for at least 80 percent of the eligible prof essional’s Medicare Part B FFS pa tients seen during the reporting period to whom the measures group applies; BUT report each measures group on no less than 15 Medicare Part B FFS patients seen during the re porting period to which the measures group applies. Measures groups containing a measure with a 0 percent performance rate will not be counted. In addition, we established the following cr iteria for satisfact orily reporting PQRS measures groups for the 6-month reporting peri od for the 2012 incentive (76 FR 73337): Report at least 1 PQRS measures group, AND report each measures group for at l east 80 percent of the eligible professional’s Medicare Part B FFS patients seen during the reporting period to whom the measures group applies; BUT report each m easures group on no less than 8 Medicare Part B FFS patients seen during the report ing period to which the measures group applies. Measures groups containing a measure with a 0 percent performance rate will not be counted. We received stakeholder feedback that it is difficult for some specialties to meet the 30 Medicare Part B FFS patient threshold. Ther efore, based on our authority under section 1848(m)(3)(D) of the Act to revise the reporting criteria for sa tisfactory reporting, we proposed the following criteria for satisfa ctory reporting of PQRS measures groups for individual eligible professionals using the registry-based re porting mechanism for the 2013 and 2014 incentives: (1) For the 12-month reporting periods fo r the respective 2013 and 2014 incentives, report at least 1 measures gr oup, AND report each measures group for at least 20 patients, a majority of which must be Medicare Part B FFS pa tients. Measures groups containing a measure with a 0 percent performance rate would not be counted. (2) For the 6-month reporting period for the respective 2013 a nd 2014 incentives, report920 at least 1 measures group, AND report each measures group for at least 20 patients, a majority of which must be Medicare Part B FFS patients. Measures group cont aining a measure with a zero percent performance rate will not be counted. We noted that this is the same criterion established for the 12-month reporting period. We proposed the same criterion for both reporting periods in an effort to simplify the re porting criteria for satis factory reporting (77 FR 44815). We noted that, while we still pr oposed to require that an eligible profe ssional report on at least 20 patients, we understood that a patient’s personal iden tification information may be stripped when data is collected via a qualified registry. Theref ore, we understood that it may be difficult to distinguish Medicare and non-Medicare patien ts. Given this difficulty and that the eligible professionals generally would be attempting to report data on Medicare patients, we felt the reporting of some non-Medica re patients could serve as a pr oxy for the reporting of Medicare patients whose data is not easily distinguishable as data on Medicare patients under this reporting mechanism. Finally, we noted that ou r proposals would satisfy the requirement under section 1848(m)(5)(F) of the Act that we provide for al ternative reporting peri ods and criteria for satisfactory reporting with regard to measur es groups and registry-based reporting. We invited public comment on the proposed criteria for satisfactory reporting of measures groups by individual eligible prof essionals via registry for the 2013 and 2014 incentives. The following is summary of the co mments we received regarding these proposals.
Comment : One commenter opposed our proposed satisfactory reporting criteria for reporting measures groups via registry for th e 6-month reporting period for the 2013 and/or 2014 PQRS incentives because the commenter was con cerned that eligible professionals who are satisfactory reporters using this criteria would only receive ha lf the allowed amount for the 2013921
and/or 2014 PQRS incentives. Response : We appreciate the commenter's feedb ack. Please note that all eligible professionals who satisfactorily report PQRS measures under the cr iteria for satisfactory reporting via registry for the 6-month reporti ng period for the 2013 and/ or 2014 PQRS incentives will receive the 2013 and/or 2014 incentive of 0.5% of our estimate of the group practice’s PFS allowed charges furnished during the applicable reporting period. Therefore, an eligible professional would earn the same incentive amou nt regardless of which reporting period the eligible professional chooses to use. In an e ffort to streamline our cr iteria for satisfactory reporting, this satisfactory reporting criterion is identical to the satisfactory reporting criterion for the 12-month reporting period.
Comment : Several commenters supported our pr oposal to lower the minimum patient count for reporting measures groups from 30 to 20. Commenters noted that lowering the reporting threshold would ease th e reporting burden of reporting measures groups for eligible professionals. Several commenters also supported our proposal to a llow for the reporting of data on non-Medicare patients. Response : We appreciate the commenters' feedb ack and are finalizing, as proposed, the criteria for satisfactory reporting of measures groups by individual eligib le professionals via registry for the 2013 and 2014 incentives. We note that, with respect to th e requirement that an eligible professional report on at least a majority (11) of the 20 patients on which the eligible professionals report, to the extent that an eligib le professional reports on more than 20 patients, for purposes of the 2013 and 2014 PQRS incentives, an eligible professional need only ensure that he/she has reported on 11 Medicare patients. Tables 90 and 91 provide a summary of the fina l criteria for the sa tisfactory reporting of PQRS quality measures for the 2013 and 2014 incentives.922
Table 90: Summary of Criteria for Satisf actory Reporting by Individual Eligible Professionals of Data on PQRS Qu ality Measures for the 2013 Incentive Reporting Period Measure Type Reporting Mechanism Proposed Reporting Criteria Jan 1, 2013— Dec 31, 2013* Individual Measures Claims Report at least 3 measures, OR, If less than 3 measures apply to th e eligible professional, report 1—2 measures*; AND Report each measure for at least 50 pe rcent of the eligible professional’s Medicare Part B FFS patients seen duri ng the reporting period to which the measure applies. Measures with a 0 percent perfor mance rate will not be counted. Jan 1, 2013— Dec 31, 2013 Individual Measures Qualified Registry Report at least 3 measures, AND Report each measure for at least 80 pe rcent of the eligible professional’s Medicare Part B FFS patients seen duri ng the reporting period to which the measure applies. Measures with a 0 percent perfor mance rate will not be counted. Jan 1, 2013— Dec 31, 2013 Individual Measures Qualified Direct EHR Product Option 1: Report on ALL three PQ RS EHR measures that are also Medicare EHR Incentive Program core measures. If the denominator for one or mo re of the Medicare EHR Incentive Program core measures is 0, report on up to three PQRS EHR measures that are also Medicare EHR Incentive Program alte rnate core measures; AND Report on three additional PQRS EHR measures that are also measures available for the Medicare EHR Incentive Program Option 2: Report at least 3 measures, AND Report each measure for at least 80 pe rcent of the eligible professional’s Medicare Part B FFS patients seen duri ng the reporting period to which the measure applies. Measures with a 0 percent perfor mance rate will not be counted. Jan 1, 2013— Dec 31, 2013 Individual Measures Qualified EHR Data Submission Vendor Option 1: Report on ALL three PQ RS EHR measures that are also Medicare EHR Incentive Program core measures. If the denominator for one or mo re of the Medicare EHR Incentive Program core measures is 0, report on up to three PQRS EHR measures that are also Medicare EHR Incentive Program alte rnate core measures; AND Report on three additional PQRS EHR measures that are also measures available for the Medicare EHR Incentive Program Option 2: Report at least 3 measures, AND Report each measure for at least 80 pe rcent of the eligible professional’s Medicare Part B FFS patients seen duri ng the reporting period to which the measure applies. Measures with a 0 percent perfor mance rate will not be counted. Jan 1, 2013— Dec 31, 2013 Measures Groups Claims Report at least 1 measures group, AND Report each measures group for at least 20 Medicare Part B FFS patients. Measures groups containing a measure with a 0 percent performance rate will not be counted. Jan 1, 2013— Dec 31, 2013 Measures Groups Qualified Registry Report at least 1 measures group, AND Report each measures grou p for at least 20 patients, a majority of which must be Medicare Part B FFS patients. Measures groups containing a meas ure with a 0 percent performance rate will not be counted Jul 1, 2013— Dec 31, 2013 Measures Groups Qualified Registry Report at least 1 measures group, AND Report each measures grou p for at least 20 patients, a majority of which must be Medicare Part B FFS patients. Measures groups containing a meas ure with a 0 percent performance923

Reporting Period Measure Type Reporting Mechanism Proposed Reporting Criteria rate will not be counted * Subject to the measure applicability validation (MAV) process. Table 91: Summary of Criteria for Satisfac tory Reporting by Individual Eligible Professionals of Data on PQRS qu ality measures for the 2014 Incentive Reporting Period Measure Type Reporting Mechanism Proposed Reporting Criteria Jan 1, 2014— Dec 31, 2014* Individual Measures Claims Report at least 3 measures, OR, If less than 3 measures apply to th e eligible professional, report 1—2 measures*; AND Report each measure for at least 50 pe rcent of the eligible professional’s Medicare Part B FFS patients seen duri ng the reporting period to which the measure applies. Measures with a 0 percent perfor mance rate will not be counted. Jan 1, 2014— Dec 31, 2014 Individual Measures Qualified Registry Report at least 3 measures, AND Report each measure for at least 80 pe rcent of the eligible professional’s Medicare Part B FFS patients seen duri ng the reporting period to which the measure applies. Measures with a 0 percent perfor mance rate will not be counted. Jan 1, 2014— Dec 31, 2014 Individual Measures Direct EHR product that is CEHRT Report 9 measures covering at least 3 domains. If an eligible professional's CEHRT does not contain patient data for at least 9 measures covering at least 3 domai ns, then the eligible professional must report the measures for which there is patient data.

Jan 1, 2014— Dec 31, 2014 Individual Measures EHR data submission vendor’s product that is CEHRT Report 9 measures covering at least 3 domains. If an eligible professional's CEHRT does not contain patient data for at least 9 measures covering at least 3 domai ns, then the eligible professional must report the measures for which there is patient data.

Jan 1, 2014— Dec 31, 2014 Measures Groups Claims Report at least 1 measures group, AND Report each measures group for at least 20 Medicare Part B FFS patients. Measures groups containing a meas ure with a 0 percent performance rate will not be counted. Jan 1, 2014— Dec 31, 2014 Measures Groups Qualified Registry Report at least 1 measures group, AND Report each measures grou p for at least 20 patients, a majority of which must be Medicare Part B FFS patients. Measures groups containing a meas ure with a 0 percent performance rate will not be counted. Jul 1, 2014— Dec 31, 2014 Measures Groups Qualified Registry Report at least 1 measures group, AND Report each measures grou p for at least 20 patients, a majority of which must be Medicare Part B FFS patients. Measures groups containing a meas ure with a 0 percent performance rate will not be counted. * Subject to the measure applicability validation (MAV) process. b. Criteria for Satisfactory Reporting for Group Practices Particip ating in the GPRO This section addresses the criteria for satisfactory reporting for group practices participating in the GPRO for the 2013 and 2014 in centives, which are th e last two incentives924 authorized under the Physician Quality Reporti ng System. Please note that, in addition to offering the GPRO web interf ace that we’ve previously included under the program, we proposed new criteria for group prac tices under the GPRO that allo w group practices to use the claims, registry, and EHR-based reporting mechan isms (77 FR 44819). In prior program years, large group practices have been su ccessful in reporting quality me asures data via the GPRO web interface. We proposed new criteria under th e claims, qualified registry, and EHR-based reporting mechanisms because we felt that smal ler groups may benefit from different reporting criteria and also other reporting mechanisms. Si nce the introduction of smaller group practices composed of 25-99 eligible professionals under th e GPRO was fairly recent, and given that we proposed to modify the definition for group prac tice such that the PQRS GPRO would include, beginning in 2013, group practices composed of 2-24 eligible professionals, we proposed additional criteria for reporting because we felt it might be more practicable for smaller group practices to report on PQRS quality measures via claims, qualified registry, or direct EHR or EHR data submission vendor versus the GPRO web interface, which was designed for use by larger group practices. (1) Beneficiary Assignment Methodology and Cr iteria for Satisfactory Reporting on PQRS Quality Measures via the GPRO Web interface GPRO Beneficiary A ssignment Methodology . To populate the GPRO web interface, we must first assign beneficiaries to each group practice and then fr om those assigned beneficiaries draw a sample of beneficiaries for the diseas e and patient care modul es in the GPRO web interface. In the proposed rule we discussed how we are assigning beneficiaries in 2012 to group practices for purposes of reporting on the PQRS quality measures via th e GPRO web interface. We proposed to continue using this same assignment methodology for 2013 and subsequent925 years because it is already in place operationally. However, as an alternative way to assign beneficiaries to groups for the GPRO web interface, in the proposed rule we also discu ssed and invited comments on using the assignment and sampling methodology utilized under the mo re recently implemented Medicare Shared Savings Program (76 FR 6700). The Medicare Shared Savings Program uses an approach that is generally similar to and is based on the appr oach previously used by the PGP Transition demonstration, but that was revi sed to reflect both our experien ces under the demonstration and specific statutory requirements for the Medicare Shared Savings Program. In particular, the attribution method used by the Medicare Shar ed Savings Program emphasizes primary care services furnished by physicians. More inform ation regarding the assi gnment methodology that is used in the Shared Savings Program can be found on the program website at https://www.cms.gov/Medicare/M edicare-Fee-for-ServicePayment/sharedsavingsprogram/index.html ?redirect=/sharedsavingsprogram/ . To more closely align with the Medicare Shared Savings Program , we invited comments on whether it would be preferable to modify the assignment method PQ RS uses to assign beneficiaries to a group practice to be more consistent with the two-step assignment me thod specified in §425.402 that is used under the Medicare Shared Savings Program to assign beneficiaries to an ACO. Consistent with that two-step methodology, in order for a beneficiary to be eligible for assignment to a group practice, the beneficiary mu st have received at least one primary care service from a physician within the group practice during the re porting period. Accordingly, we would identify beneficiaries who received at least one primary care service from any group practice physician (regardless of specialty) participating in the group practice during the reporting period. Under the first assignment step, we would assi gn the beneficiary to the group practice if the beneficiary had at least one primary care service furnished by a primary care926 physician at the participating group practice, and more primary care services (measured by Medicare allowed charges) furnished by prim ary care physicians in the participating group practice than furnished by primary care physicians at any other group or solo practice. The second step applies only for those bene ficiaries who do not receive any primary care services from a primary care physician during the reporting period. We would assign the beneficiary to the participating group practice in this step if the beneficiary had at least one primary care service furnished by a group practice physician regardless of specialty, and more primary care services were furnished by group practice eligible prof essionals (measured by Medicare allowed charges) at th e participating group practice than at any other group or solo practice We would then pull samples of benefi ciaries for the relevant measures/modules from this population of assigned beneficiaries to populat e the GPRO web interface. In other words, the GPRO web interface would be populated base d on a sample of the group practice assigned beneficiary population. Gr oup practices would need to complete the tool for the first 411 or 218 consecutively ranked and assigned be neficiaries in the order in wh ich they appear in the group’s sample for each domain, measures set, or indivi dual measure if a separate denominator is required such as in the case of preventive care m easures which may be specific to one sex. If the pool of eligible assigned beneficiaries is le ss than 411 or 218, the group practice would report on 100 percent of assigned beneficiar ies for the domain, measure set, or individual measure. The GPRO web interface would need to be completed for all domains, measure sets, and measures described in Table 96. We considered making this change to th e assignment method beginning with the 2013 PQRS GPRO web interface so that the rules us ed to assign beneficiaries to group practices participating in PQRS and ACOs participating in the Medicare Shared Savings Program would be more consistent. Since both group practices that are participating in the PQRS GPRO and927 ACOs participating in the Medicare Shared Sa vings Program would be using the same GPRO web interface to report the same set of quality measures to CMS, we believe that applying consistent assignment methods across the tw o programs would allow us to streamline our processes and could potentially reduce conf usion among group practices considering participation in the PQRS GPRO or ACOs cons idering participation in the Medicare Shared Savings Program. We invited public comment whether to continue to use the PQRS-established methodology for assigning beneficiaries, or, in the alternative, to use the assignment and sampling methodology utilized under the Medicare Shared Savings Program. The following is summary of the comments we rece ived regarding these proposals.
Comment : One commenter supported our proposa l to continue the assignment and sampling methodology currently being used to p opulate the GPRO web interface. However, another commenter urged CMS to adopt an assi gnment and sampling me thodology that is more focused on primary care, as the commenter believ es that medical colleges participating in the GPRO will experience more success in reporting via the GPRO web interface with this change. Response : We appreciate the commenters’ feedb ack. We appreciate the commenters’ feedback. In an effort to align with the Me dicare Shared Savings Program, we are adopting the beneficiary assignment and sa mpling methodology used under the Medicare Shared Savings Program, which, unlike the current methodology to populate the GPRO web interface, requires that the beneficiary being assi gned had at least one primary ca re service furnished by a group practice physician. We understand th at as a result of this requirem ent, there could be some group practices (such as groups consisting only of non- physician practitioners) th at would not be able to report PQRS quality measures using the GPRO web interface because no beneficiaries would be assigned to them. However, we do not e xpect this would aff ect many group practices928 reporting PQRS quality measures using the GPRO web interface. We offer a number of other options for participating in PQRS. We note that the assignment and sampling methodology does not depart drastically from the assignment and sampling methodology currently used to populate the GPRO web interface as both methods were based off of the assignment and sampling methodology used under the PGP demonstration. Therefore, we are modifying 414.1240 to reflect the final decision to a pply the same assignment and samp ling methodology as is currently used under the Medicare Shared Savings Program. Criteria for Satisfactory Reporting on PQ RS Quality Measures via the GPRO Web interface. Consistent with the group practi ce reporting requirements under section 1848(m)(3)(C) of the Act, we proposed the followi ng criteria for the satisfactory reporting of PQRS quality measures for group practices par ticipating- in the GPRO for the 12-month reporting periods for the 2013 and 2014 incentives, respectively, using th e GPRO web interface for groups practices of 25-99 eligible professiona ls: Report on all measures included in the web interface; AND populate data fields for the first 218 consecutively ranked and assigned beneficiaries in the order in which they appear in the group's sample for each disease module or preventive care measure (77 FR 44820). If the pool of eligible assigned be neficiaries is less than 218, then report on 100 percent of assigned beneficiar ies. In other words, we understand that, in some instances, the sampling methodology CMS provide s will not be able to assign at least 218 patients on which a group practice may report, pa rticularly those group practices on the smaller end of the range of 25-99 eligible professionals . If the group practice is assigned less than 218 Medicare beneficiaries, then the group practice would repor t on 100 percent of its assigned beneficiaries. In addition, we proposed the fo llowing criteria for the satisfactory reporting of PQRS quality measures for group practices pa rticipating in the GPRO for the 2013 and 2014 incentives, respectively, using gr oup practices of 100 or more elig ible professionals: Report on929

all measures included in th e web interface; AND populate data fields for the first 411 consecutively ranked and assigned be neficiaries in the order in wh ich they appear in the group's sample for each disease module or preventive care measure. If the pool of eligible assigned beneficiaries is less than 411, then report on 100 percent of assigned beneficiaries. The satisfactory reporting criter ia we proposed for the GPRO web interface for groups of 25-99 eligible professionals and for large group practices for the 2013 and 2014 incentives were consistent with the reporting cr iteria we established for the 20 12 PQRS incentive (76 FR 73339). We proposed these same criteria because the thres holds proposed for these criteria were based on analysis performed on group reporting based on the Medicare Care Management Performance (MCMP) and PGP demonstrations used to dete rmine reasonable threshol ds for group practice reporting. We also note that ther e are the same criteria used for ACOs participating in the Medicare Shared Savings Program. Therefore, we believed the satis factory reporting criteria that for the GPRO web interface for the 2013 and 2014 incentives were appropriate criteria and reasonable for groups to meet. Furthermore, we proposed using Medicare Part B claims data for dates of service on or after January 1 and submitted and processed by approximately the last Friday in October of the applicable 12-month reporting period under which th e group practice particip ates in the GPRO to assign Medicare beneficiaries to each group practice. For example, for a group practice participating under the GPRO for the reporti ng periods occurring in 2013, for the sampling model, we proposed that we would assign bene ficiaries on which to re port based on Medicare Part B claims with dates of service begi nning January 1, 2013 and processed by October 25, 2013 (77 FR 44820). We invited but received no public comm ent on the proposed satisfactory reporting criteria on PQRS quality measures via the GPRO web interface. Therefore, we are finalizing930 these proposals as proposed. These crit eria are specified in Tables 27 and 28. (2) Criteria for Satisfactory Reporting on I ndividual PQRS Quality Measures for Group Practices Participating in the GP RO via Claims, Re gistry, and EHR We proposed to have the claims, registr y, and EHR reporting mechanisms available for group practices of 2-99 eligible professionals to use to report PQRS quality measures (77 FR 44820). For these group practices, we proposed alte rnative criteria to t hose proposed under the GPRO web interface for satisfact ory reporting for the 2013 and 2014 in centives using the claims, registry, and EHR-based reporting mechanisms that mirror the criteria we proposed for individual reporting for the cl aims, registry, and EHR-based reporting mechanisms from the 2013 and 2014 incentives. We noted that the criteria we proposed for the 2013 and 2014 incentives using the claims, regi stry, and EHR-based reporting m echanisms are similar to the criteria for individual reporting, because we belie ve smaller group practices are more akin to individuals for practice scope. We believed that the larger the group pr actice, the more likely that the group practice would be nefit using the reporti ng options under the GP RO web interface. Therefore, based on our authority under se ction 1848(m)(3)(C) of the Act, we proposed the following satisfactory reporting criteria via claims for group practi ces comprised of 2-99 eligible professionals under the GPRO for the 2013 and 2014 incentives via claims: Report at least 3 measures AND report each measure for at least 50 percent of the group practice’s Medicare Part B FFS patients seen during the repo rting period to which the measure applies. Measures with a zero percent perf ormance rate will not be counted. For those group practices that chose to repor t using a qualified registry, we proposed the following satisfactory reporting crit eria via qualified registry fo r group practices comprised of 2- 99 eligible professionals under the GPRO for the 2013 and 2014 incentives: Report at least 3 measures AND report each measure for at least 80 percent of the group practice's Medicare Part931 B FFS patients seen during the repo rting period to which the measur e applies. Measures with a zero percent performance rate will not be counted. For group practices comprised of 2-99 eligible professionals that chose to report PQRS quality measures via EHR, we proposed the fo llowing 2 options for th e satisfactory reporting criteria via a direct EHR produc t or EHR data submission vendor for group practices comprised of 2-99 eligible professionals unde r the GPRO for the 2013 incentive: Option 1 : Eligible professionals in a group prac tice must report on three Medicare EHR Incentive Program core or alternate core measur es, plus three additional measures. We noted that the EHR Incentive Program’s core, alternate core, and additio nal measures could be found in Table 6 of the EHR Incentive Program’s Stage 1 fina l rule (75 FR 44398) or in Tables 32 and 33 of the proposed rule (77 FR 44821). We also re ferred readers to the di scussion in the Stage 1 final rule for further explanation of the require ments for eligible profe ssionals reporting those CQMs (75 FR 44398 through 44411). Option 2 : Report at least 3 measures AND report each measure for at least 80 percent of the eligible professional’s Me dicare Part B FFS patients seen during the reporting period to which the measure applies. Measures with a zero percent performance rate will not be counted. We noted that at the time of the CY 2013 PFS proposed rule, that we had proposed under the Medicare EHR Incentive Program 2 options fo r meeting the CQM com ponent of achieving meaningful use beginning w ith CY 2014 (see 77 FR 13746—13748). To align our EHR-based reporting requirements with those proposed under the Medicare EHR Incentive Program at the time, we proposed the following criteria for sa tisfactory reporting using the EHR-based reporting mechanism for the 12-month repor ting period for the 2014 incentive:

● Option 1a : Select and submit 12 clinical quality measures available for EHR-based reporting from Tables 32 and 33, including at l east 1 measure from each of the following 6932 domains – (1) patient and family engagement, (2) patient safety, (3) care coordination, (4) population and public health, (5) efficient use of healthcare resources , and (6) clinical process/effectiveness (77 FR 44821).

● Option 1b : Submit 12 clinical quality measures composed of all 11 of the proposed Medicare EHR Incentive Program core clinical quali ty measures specified in Tables 32 and 33 of the proposed rule plus 1 menu clinical quality measure from Tables 32 and 33 of the proposed rule. We proposed to adopt the group reporting criter ia that aligns with the criteria that would be established for meeting the CQM component under CY 2014 for the Medicare EHR Incentive Program. Furthermore, to the extent that the final group reporting criter ia for meeting the CQM component of achieving meaningful use differ from what was proposed, our intention was to align with the group reporting criteria the EH R Incentive Program ultimately established. We invited public comment on this proposal. We also considered proposing the followi ng satisfactory reporti ng criteria for the 2014 PQRS incentive for groups of 2-99 that was simila r to the satisfactory re porting criteria being proposed for the 2013 PQRS incentive via EHR: report at least 3 measures, AND report each measure for at least 80 percent of the group prac tice’s Medicare Part B FFS patients seen during the reporting period to wh ich the measure applies. Measures with a zero percent performance rate will not be counted (77 FR 44821). We invited public comment on this alternative considered. We invited public comment on the proposed criteria for satisfactory reporting of individual measures by group practices via claims, registry, or EHR for the 2013 and 2014 incentives. The following is a summar y of general comments we received.
Comment : Several commenters supported our proposal to expand the reporting mechanisms and satisfactory repo rting criteria for group practice s participating in the GPRO.933 The commenters believe that establishing these pr oposals would lead to gr eater overall program participation. Response : We appreciate the commenters' positiv e feedback. We are finalizing all proposed criteria for the satisfa ctory reporting of PQRS quality m easures via the GPRO using the registry-based reporting mechanisms for groups of 2-99 eligible professionals for the 2013 and 2014 PQRS incentives, as proposed. In additi on, to align with the EHR Incentive Program, which will introduce a group prac tice reporting option in 2014, we are delaying implementing criteria for satisfactory reporting for group practi ces of 2-99 eligible professionals to 2014. The details of the EHR reporting criterion for group pract ices are discussed in greater detail below. However, since we have determined that it is not technically feasible to accept group reporting via the claims-based reporting mechanism at th is time, we are not finalizing our proposed reporting criteria for group pr actices using the claims-based reporting mechanism for the 2013 and 2014 PQRS incentives at this time.
Comment : One commenter opposes offering vary ing reporting criteria, depending on group size and reporting method. The commenter believes that these varying methods of reporting unnecessarily complicates the progr am and provide a strong disincentive for participation. Response : We understand the commenter’s con cern regarding the complexity of reporting under PQRS. Therefore, we have made an effort to streamline reporting criteria wherever possible. For example, the criteria we are establishing for satisfactory reporting using the registry and EHR-based reportin g mechanisms are similar whether an eligible professional is reporting PQRS measures as part of a group in a GPRO or as an individual. However, we believe it is necessary to offer different repor ting options and varying criteria to provide flexibility in reporting as well as ensure that the reporting threshold we are establishing is934 appropriate given a partic ular group practice's size and resour ces. We also note that it is not necessary for eligible professionals and group pr actices to meet the cr iteria for satisfactory reporting for the PQRS incentives or payment ad justments using multiple criteria and reporting mechanisms. Eligible professionals and group practices need only chose one criterion under which to report.
Comment : One commenter sought cl arification on how many eligible professionals within the group practice would be required to report PQRS meas ures using the proposed GPRO satisfactory reporting crit eria for the claims, registry, and EHR-based reporting mechanisms for the 2013 and 2014 PQRS incentives. The commente r suggests that CMS not focus on requiring a certain amount of eligible professionals with in the group practice to report but, instead, focus on a group practice's aggregate patients. Response : We clarify that the criteria we esta blish for reporting usi ng the registry and EHR-based reporting mechanisms does not requir e every eligible professional in the group practice to report PQRS measures. Rather, we note that the criteria we establish focuses on the group reporting on a certain percenta ge of its applicable patients, regardless of how many of the group practice's eligible professiona ls participate in reporting the PQRS measures. For example, if a group practice comprised of 10 eligible professionals particip ating in the GPRO chooses to report PQRS measures using th e registry-based re porting mechanism, the group practice must report on at least 3 measures for 80 percent of the group practice's a ggregate applicable patients. A measure is applicable to a patient if the servic e provided to the patient and billed to Medicare under the Physician Fee Schedule is contained in the denominator of a measure. For more information on the PQRS measures, including wh at types of services are contained in the denominator of certain measures, pl ease visit the PQRS website at http://www.cms.gov/Medicare/Quality -Initiatives-Patient-Assessment-935
Instruments/PQRS/index.html to view the PQRS Measures List and Implementation Guide for the relevant year. It is irrele vant whether 5 or all 10 of the gr oup practice's eligible professionals report. We would imagine, however, that a group practice would have to report on a larger set of patients the larger the group size.
Comment : One commenter urged CMS to expand the proposed satisfactory reporting criteria of individual PQRS measures under the GPRO using the claims, registry, and EHR based reporting mechanisms to groups of 100 or more eligible professionals. The commenter notes that the measures available for reporting using the GPRO web interface are limited, so expanding the proposed claims, registry, and EHR-based reporting options under th e GPRO would allow greater flexibility for large specialty practices to report on PQRS measures. Response : We agree with the commenter's feedbac k. Our desire to encourage specialties to submit meaningful measure data outweighs our desire to restrict the GPRO registry and EHRbased reporting options to smaller groups of 2-99 eligible professiona ls. We provided our reasons for limiting our proposal to restrict the registry and EH R-based reporting mechanisms to groups of 2-99 eligible professionals in the CY 2012 PFS proposed rule (76 FR 44821). Specifically, we stated that th e reporting behavior of these sm aller group practices would be more akin to individual reporting. However, we have received stakeholder feedback, such as the commenter’s, that large groups (mai nly large single specialty groups ) find it more beneficial to report via registry or EHR as the measures ava ilable under these reporti ng mechanisms are more applicable to the group’s practice. Stakeholders have also expressed con cern that it is difficult for their billing departments to keep track of th e reporting activities of eac h individual eligible professional. Providing a group practice reporting option for th ese groups would reduce the administrative burden these large single specialty pr actices incur from having to keep track of the group practice’s reporting activity by each individua l TIN/NPI combination. Therefore, we will936 expand the GPRO qualified regist ry and EHR-based reporting opti ons to groups of 100 or more eligible professionals.
Comment : One commenter stressed the importance of allowing eligible professionals to still report as individuals desp ite these newly proposed group reporting options under the GPRO. The commenter noted that requiri ng eligible professionals to pa rticipate in PQRS under their respective group practices would have a negative impact on registries. The commenter noted that, historically, eligible prof essionals choosing to participate in PQRS independent of their group practice have used the regist ry-based reporting mechanism. The commenter believed that the registries have been particul arly successful in collecting data relevant for measuring quality of care furnished to patients. Response : CMS understands the need to establ ish reporting criteria for eligible professionals who wish to participate in PQRS i ndependent of the other eligible professionals in their group practice. We note that the proposal to establish satis factory reporting criteria using the claims, registry, and EHR-based reporting m echanisms for group practices using the GPRO was not intended to eliminate repor ting options for eligible professi onals who wish to participate in PQRS as individuals. These options are sti ll available for individual reporting. Please note, however, that should an eligible professional fall under a TIN that el ects to participate in PQRS using the GPRO, the eligible professional must part icipate in PQRS as part of the group practice. The eligible professional can no longer participate as an individual.
Comment : With regard to the satisfactory reporti ng criteria we proposed for groups in the GPRO using direct EHR products or EHR data submission vendor, one commenter noted that, should we finalize these proposed re porting criteria, the PQRS would be out of sync with Stage 1 of the Medicare EHR Incentive Program, whic h did not establish a group practice reporting option. The commenter did note, however, that the EHR Incentive Program established an EHR-937 based reporting option for group practic es under Stage 2, which begins in 2014. Response : We agree with the commenter that our proposed Options 1 and 2 for the satisfactory reporting of measures using the EHR-based reporting mechanism under the GPRO for the 2013 PQRS Incentive do not align with the requirements for meeting the CQM component of meaningful use in 2013 of the EHR Incentive Program, as there is no group reporting option for CQMs for the Medicare EH R Incentive Program until 2014. Therefore, we are not finalizing the following proposed sati sfactory reporting criteria for the 2013 PQRS Incentive: (1) Option 1: Eligible professionals in a group practi ce must report on three Medicare EHR Incentive Program core or alternate core me asures, plus three additional measures and (2) Option 2: Report at least 3 m easures, AND report each measure fo r at least 80 pe rcent of the group practice's Medicare Part B FFS patients se en during the reporting period to which the measure applies. Measures with a zero perc ent performance rate wi ll not be counted. However, we finalized for the EHR Incentive Program two group reporting options beginning in 2014 for the CQM com ponent of achieving meaningful use, one of which is the following: Medicare EPs who satisfactorily re port PQRS CQMs using CEHRT under the PQRS GPRO would be considered to have satisfied their CQM reporting requirement as a group for the Medicare EHR Incentive Program (77 FR 54076 through 54078). In the proposed rule, we proposed 3 GPRO options for the satisfactory reporting of PQRS individual measures. However, we also indicated that it was our intent to fina lize reporting criterion that aligns with the CQM requirements for achieving meaningful use in th e EHR Incentive Program. Following the criteria we finalized for the satisfactory reporting of individual PQRS quality measures using a direct EHR product or EHR data submission vendor for individual eligible professionals, we are finalizing the following criteria for the satisfact ory reporting of data on PQRS quality measures via the GPRO for the 2014 Incentive: Report 9 measur es covering at least 3 domains specified in938 Table 95. If the group practice’s CEHRT does not c ontain Medicare patient data for at least 9 measures covering at least 3 domains, then the group practice must report the measures for which there is Medicare patient data. A group practi ce must report on at least 1 measure for which there is Medicare patient data. Although we proposed three reporting criteria for the satisfactory reporting of PQRS measures via an EHR-based reporting mechanis m under the GPRO for the 2014 PQRS incentive, we are only finalizing one GPRO EHR reporting criterion. Simila r to the reasoning we provided to streamline the reporting criteria for reporti ng measures groups via registry for the 2013 and 2014 PQRS incentives, it is our desire to prov ide one streamlined repor ting option via EHR for group practices participa ting in the GPRO. We note that we believe these proposed criter ia meet the requiremen ts for group practice reporting specified in section 1848 (m)(3)(C) of the Act. Section 1848(m)(3)(C) requires that the criterion for group reporting use a statistical sampli ng model, such as the model used in the PGP demonstration. We note that, although these crite ria depart from the model used in the PGP demonstration, we believe that these criteria stil l meet the statistical sampling model requirement in that the group practices would still be require d to report the measures on a sample of their patients. Rather than CMS choosing which samp le of patients the group practice must report, with these criteria, the group practice decides to submit quality measures data on a sample of 100 percent of its patients. We note that although reporting on 100 percent of patients is not a sample, for data collection purposes, CMS w ould only collect data on the group practice’s patients to which the EHR measures apply. Therefore, even though a group practice would report on 100 percent of patients to which the m easure applies, not all of the EHR measures would necessarily apply to all of the group practice’s patients. Si nce the group practice is then only providing information on its patients to whom the measure is applicable, we believe the939 proposed EHR reporting criteria would still meet the statistical sampling model requirement. A summary of the final criteria for satisfact ory reporting for group practices selected to participate in the GPRO for the 2013 and 2014 in centives is specified in Tables 92 and 93: TABLE 92: Criteria for Satisfactory Reportin g of Data on PQRS Quality Measures via the GPRO for the 2013 Incentive Reporting Period Reporting Mechanism Group Practice Size Proposed Reporting Criterion 12-month (Jan 1 — Dec 31) GPRO Web interface 25-99 eligible professionals Report on all measures included in the web interface in Table 96; AND Populate data fields for the firs t 218 consecutively ranked and assigned beneficiaries in the order in which they appear in the group’s sample for each module or preventive care measure. If the pool of eligible assigned beneficiaries is less than 218, then report on 100 percent of assigned beneficiaries. 12-month (Jan 1 — Dec 31) GPRO Web interface 100+ eligible professionals Report on all measures included in the web interface in Table 96; AND Populate data fields for the firs t 411 consecutively ranked and assigned beneficiaries in the order in which they appear in the group’s sample for each module or preventive care measure. If the pool of eligible assigned beneficiaries is less than 411, then report on 100 percent of assigned beneficiaries. 12-month (Jan 1 — Dec 31) Qualified Registry 2+ eligible professionals Report at least 3 measures, AND Report each measure for at least 80 percent of the group practice’s Medicare Part B FF S patients seen during the reporting period to which the measure applies. Measures with a 0 percent perfor mance rate will not be counted. * Subject to the measure applicab ility validation (MAV) process. Table 93: Criteria for Satisfactory Reportin g of Data on PQRS Quality Measures via the GPRO for the 2014 Incentive Reporting Period Reporting Mechanism Group Practice Size Proposed Reporting Criterion 12-month (Jan 1 — Dec 31) GPRO Web interface 25-99 eligible professionals Report on all measures included in the web interface in Table 96; AND Populate data fields for the firs t 218 consecutively ranked and assigned beneficiaries in the order in which they appear in the group’s sample for each module or preventive care measure. If the pool of eligible assigned beneficiaries is less than 218, then report on 100 percent of assigned beneficiaries. 12-month (Jan 1 — Dec 31) GPRO Web interface 100+ eligible professionals Report on all measures included in the web interface in Table 96; AND Populate data fields for the firs t 411 consecutively ranked and assigned beneficiaries in the order in which they appear in the group’s sample for each module or preventive care measure. If the pool of eligible assigned beneficiaries is less than 411, then report on 100 percent of assigned beneficiaries. 12-month (Jan 1 — Dec 31) Qualified Registry 2+ eligible professionals Report at least 3 measures, AND Report each measure for at least 80 percent of the group practice’s Medicare Part B FFS patients seen during the reporting period to which the measure applies. Measures with a 0 percent perfor mance rate will not be counted. 12-month Direct EHR 2+ eligible Report 9 measures covering at least 3 domains. If the group940

Reporting Period Reporting Mechanism Group Practice Size Proposed Reporting Criterion (Jan 1 — Dec 31) product that is CEHRT or EHR Data Submission Vendor’s Product that is CEHRT professionals practice’s CEHRT does not contain patient data for at least 9 measures covering at least 3 domai ns, then the group practice must report the measures for which there is patient data.

* Subject to the measure applicab ility validation (MAV) process. c. Analysis of the Criteria for Satisf actory Reporting for the 2013 and 2014 Incentives For the proposed criteria for satisfact ory reporting for the 2013 and 2014 incentives described in this section, we pr oposed that eligible professionals and group practices may not combine different satisfactory reporting criteria under different reporting mechanisms to meet the requirements of satisfactory reporting fo r the 2013 and 2014 incentives (77 FR 44824). For example, an eligible professional may not meet the requirements for the 2013 incentive by reporting on 2 applicable PQRS quality measures via EHR and 1 applicable PQRS quality measure via qualified registry, because the eligib le professional did not meet the criteria for satisfactory reporting under at l east one reporting mechanism. Similarly, a group practice would be required to select a single reporting mechanis m for the entire group practice. For example, for a group practice consisting of 4 e ligible professionals, the group pr actice would not be able to meet the requirements for the 2014 incentive by reporting 2 individual measures via qualified registry and 1 measure via the direct EHR submission method. For individual eligible prof essionals and group practices re porting on individual measures and/or measures groups, we noted that, although an eligible prof essional or group practice could meet more than one criterion fo r satisfactory reporting, only one incentive payment will be made to the eligible professional or group practice. For example, if an eligible professional meets the criteria for satisfactory reporti ng of individual measures via cl aims and measures groups via claims for the 2013 incentive, the eligible professional would nonetheless only be entitled to one941 incentive payment. CMS would consider the elig ible professional to be incentive eligible under whichever reporting criterion yi elds the greatest bonus. We invited but received no public comment on our proposed analysis of the criteria for satisfactory reporting for the 2013 and 2014 incentives. Therefore, we are finalizing this analysis rule. 5. Criteria for Satisfactory Reporting for the Payment Adjustments Section 1848(a)(8) of the So cial Security Act, as a dded by section 3002(b) of the Affordable Care Act, provides that for covered professional services fu rnished by an eligible professional during 2015 or any subsequent ye ar, if the eligible professional does not satisfactorily report data on quality measures fo r covered professional services for the quality reporting period for the year, the fee schedule amount for services furnished by such professional during the year shall be equal to the applicable percent of th e fee schedule amount that would otherwise apply to such servic es. The applicable percent fo r 2015 is 98.5 percent. For 2016 and subsequent years, th e applicable percent is 98.0 percent. This section contains the fi nal criteria for satisfactory re porting for purposes of the 2015 and 2016 payment adjustments for eligible profes sionals and group practices , as well as some discussion of what we are considering for the payment adjustments for 2017 and beyond. As stated previously, the majority of eligib le professionals currently are not participating in the PQRS. Yet, the payment adjustment will apply to all eligible professionals who are not satisfactory reporters during the reporting period for the year. Therefore, we noted that in implementing the PQRS payment adjustment, we seek to achieve two overarching policy goals. First, and foremost, we sought to increase part icipation in the PQRS and to implement the payment adjustment in a manner that will allow eligible professionals who have never participated in the program to familiarize them selves with the program. Second, we sought to942 align the reporting requirements under the PQRS with the quality reporting requirements of various CMS programs, such as the physician valu e-based payment modifier discussed in section III.K of this final rule with comment period. a. Criteria for Satisfactory Reporting for th e 2015 and 2016 Payment Adjustments for Eligible Professionals and Group Practices using the Cl aims, Registry, EHR, and GPRO web interface Reporting Mechanisms This section addresses th e criteria for satisfactor y reporting for the 2015 and 2016 payment adjustments using the claims, regist ry, EHR-based, and GPRO web interface reporting mechanisms. First, we proposed that for purposes of the 2015 and 2016 payment adjustments (which would be based on data reported during 12 and 6-month reporting pe riods that fall within 2013 and 2014, respectively), an e ligible professional or grou p practice would meet the requirement to satisfactorily report data on quality measures for covered professional services for the 2015 and 2016 payment adjustments by meeting the requirement for satisfactory reporting for the 2013 and 2014 incentives re spectively (77 FR 44824). That is, we proposed the exact same criteria for satisfactory reporting for the 2015 and 2016 payment adjustments that we proposed for the 2013 and 2014 incentives, described in Tables 25 and 26 of the proposed rule, with the exception of two addi tional alternative criteria. Since we had already proposed satisfactory reporting criteria for the 2013 and 2014 incentives and the reporting periods for the respective 2013 and 2014 incentives and 2015 and 2016 payment adjustments coincide, we felt it was appropriate that the proposed criteria for the 2013 and 2014 in centives apply to satisfy the satisfactory reporting requirements for the 2015 and 2016 payment adjustments, respectively. We noted that these proposed criteria fo r the 2013 and 2014 PQRS incentives were the only criteria we proposed to establish for the respective 2015 and 2016 PQRS payment adjustments for group practices using th e GPRO web interface.943 For individual eligible prof essionals also participating in the EHR Incentive Program, we noted that it is our intention to align our pr oposed criteria for satisfa ctory reporting for the 2015 and 2016 PQRS payment adjustments with the cr iteria for meeting the CQM component of meaningful use applicable during the 2015 and 2016 PQRS payment adjustment reporting periods. For eligible professionals participa ting in PQRS and the EH R Incentive Program using a direct EHR product or EHR data submission vendor that is CEHRT, we noted that since we proposed to align our proposed EHR criteria for satisfactory reporting for the 2013 and 2014 PQRS incentives with the proposed criteria for meeting the CQM component of meaningful use for CYs 2013 and 2014if these proposals were esta blished and we meet our goal of aligning the two programs, an eligible professional that me t the CQM component of meaningful use during the PQRS 2015 and 2016 payment adjustment re porting periods occurring in CYs 2013 and 2014 respectively using a direct EHR product or EHR data submission vendor that is CEHRT would meet the requirements for satisfactory reporting for the 2015 and 2016 PQRS payment adjustments by submitting a single set of data. We invited public comment on our proposal s related to applyi ng the satisfactory reporting criteria established for the 2013 and 2014 PQRS incentives for eligible professionals and group practices using the GPRO to the respective 2015 and 2016 PQRS payment adjustments. The following is a summary of th e comments we received on these proposals.
Comment : Several commenters supported applyi ng the satisfactory reporting criteria established for the 2013 and 2014 PQRS incentives fo r eligible professionals and group practices using the GPRO to the respective 20 15 and 2016 PQRS payment adjustments. Response : We appreciate the commenters’ support for these proposals an d are, therefore, finalizing these proposals, as proposed. In addition, as a result of the overarchi ng goals we have articulated above about944 encouraging participation and c oncern about eligible professiona ls’ familiarity and experience with the program, we proposed the following altern ative criteria for sati sfactory reporting during the 12-month reporting periods for the 2015 a nd 2016 payment adjustments for eligible professionals and group practices: report 1 (app licable) measure or measures group using the claims, registry or EHR-based reporting mechanis ms. We noted that th is particular proposed alternative criterion for satisfactory reporting was significantly less stringent that the satisfactory reporting criteria we have proposed for the 2013 a nd 2014 incentives. However, we stressed that we were proposing less stringent criteria only to ease eligible professi onals and group practices who have not previously partic ipated in PQRS into reporting into the mechanics of reporting quality measures under PQRS. As indicated in the proposed rule, for the 2017 PQRS payment adjustment and beyond, we anticipate eliminatin g these alternative proposed criteria and establishing criteria that more closely resemble the proposed satis factory reporting criteria for the 2013 and 2014 incentives (77 FR 44826). For group practices, section 1848(m)(3)(C) requ ires that the criterion for group reporting use a statistical sampling model, such as the mode l used in the PGP demonstration, we noted that we believed that the proposed reporting criteria met this stan dard, as the group practice would decide on which sample of patients to report (77 FR 44825). Under the proposed criteria, the group practice would select the sample number, meaning the group could choose to report on all applicable patients or a certain number of patient s to which the particular measure applied. We noted that, although the group practi ce could choose the sample, we expected that the sample the group practice selects would represent a sufficient picture of the benefici aries the group practice

sees. We invited public comments on these proposed criteria for satisfactory reporting for the 2015 and 2016 payment adjustments for eligible professionals and group practices using the945 claims, registry, EHR-based reporting mechan isms. The following is a summary of the comments we received regard ing these proposed criteria.
Comment : Realizing the need to increase part icipation in PQRS, several commenters generally supported our proposed ph ased approach of introduci ng more lenient satisfactory reporting criteria for the 2015 and 2016 PQRS paymen t adjustments with the intention of moving towards more stringent satisfactor y reporting criteria, such as th e satisfactory re porting criteria established for the 2013 and 2014 PQRS incenti ves, for future payment adjustments. Response : We appreciate the commenters' posi tive feedback on our proposals for satisfactory reporting for the 2015 and 2016 PQRS payment adjustments.
Comment : Several commenters supported our proposed criteria for satisfactory reporting for the 2015 and 2016 PQRS payment adjustments: Reporting 1 measure or measures group. These commenters believed that these proposed cr iteria would help ensure that an eligible professional who makes a good faith effort to re port PQRS measures would avoid the 2015 and 2016 PQRS payment adjustments. In fact, some commenters suggested that we establish these criteria for the 2017 PQRS payment adjustment and beyond. Response : We are not finalizing these reporti ng criteria for the 2017 PQRS payment adjustment and beyond. We note that we proposed th ese criteria to help eligible professionals and group practices who are particip ating in PQRS for the first time to become familiar with the PQRS reporting requirements. We believe th at, by the reporting period for the 2017 PQRS payment adjustment, eligible professionals and group practices should be held to satisfactory reporting criteria that are iden tical or similar to the satisf actory reporting criteria we are establishing for the 2013 and 2014 PQRS incentives. Based on the comments received and for the re asons previously state d, we are finalizing the proposed criteria for satis factory reporting for the 2015 PQRS payment adjustment -- Report946 1 measure or measures group during the appli cable payment adjustment reporting period. Therefore, an individual eligible professional will meet the criter ia for satisfactory reporting for the 2015 payment adjustment if the eligible pr ofessional reports 1 measure or, for eligible professionals only, measures group using a clai ms, qualified registry, or EHR-based reporting mechanism during the applicable payment adjustment reporting pe riod. Unlike the criteria for satisfactory reporting for the 2013 and 2014 PQRS incentives, which re quires an eligible professional to report on measures based on a percentage of applic able patients or patient count, this criterion only requires that an eligible pr ofessional or group practi ce report on 1 measure or, for individual eligible professionals only, 1 measures group fo r at least 1 applicable patient. However, we strongly encourage eligible prof essionals and group practices to report on as many applicable patients as possible. For group practices, please note that since we are not finalizing the claims-based reporting option for group prac tices, we are not finalizing this reporting criterion for satisfactory reporting for the claims-based reporting mechanism for group practices. Although we did not propose using the GPRO web interface as a repo rting mechanism to report 1 measure to meet the criteria for sa tisfactory reporting for the 2015 PQRS payment adjustment, we did propose this criterion for th e other three traditiona l reporting mechanisms (claims, registry, and EHR). We anticipated that it would be sufficient to establish this criterion for these three other reporting mechanisms (c laims, registry, and EHR) for the 2015 PQRS payment adjustment. However, as we previously stated, we are not fina lizing the claims-based reporting mechanism for group practices participati ng in the GPRO. We ar e also not finalizing the EHR-based reporting mechanism for group pract ices participating in the GPRO until 2014. Therefore, since the registry-based reporting mechanism will be the only reporting mechanism under which group practices would be able to use this criterion, we are expanding this criterion for use under the GPRO web interface. Therefor e, a group practice will not be subject to the947 2015 payment adjustment if the group practice m eets the criteria for satisfactory reporting by reporting 1 applicable measure using a qualified registry or the GPRO web interface reporting mechanism during the CY 2013 payment adjustment reporting period. We are not finalizing these proposed criteria for the 2016 payment adjustment at this time, as we intend to revisit whether we shoul d establish more stringe nt satisfactory reporting criteria beginning with the 2016 payment adjustment . We believe that, rather than maintaining this criterion for the 2016 PQRS payment adjust ment, it may be more preferable to adopt a phased approach to moving towards reporting criteria th at is identical to or similar to the criteria for satisfactory reporting for the 2013 and 2014 PQRS incentives. However, as we explained above, we are finalizing one criterion for sa tisfactory reporting for the 2016 PQRS payment adjustment: meet the criteria for satisfact ory reporting for the 2014 PQRS incentive.
Comment : Some commenters sought clarification on how the PQ RS payment adjustment will be applied to specialties for which little to no relevant measures exist in the PQRS measures set, such as audiologists and endocrinologists. One commenter is concerned that endocrinologists who specialize in thyroid conditions will be unable to meet the proposed criteria for satisfactory reporting, as the commenter be lieves there are no pr oposed PQRS measures specific to the treatment of thyroid disease. Response : Although the proposed PQRS measures se t contains a broad set of measures, we understand that, in rare cases, there remains ce rtain sub-specialties that may not be able to find relevant PQRS measures on which to report. However, pl ease note that the PQRS measure set contains a broad set of measures that may in fact be applicable to these sub-specialties and relevant to their specific practice area. Many measures have broad denominator codes and code sets that apply to the majority of eligible pr ofessionals. Therefore, we urge these eligible professionals and group practices to contact our QualityNet Help Desk for advice on reporting948 and determining whether applicable measures can be found in the PQRS measure set. Meanwhile, to the extent possible, we will continue to work with stakeholders to ensure that the PQRS measure set addresses gaps for future program years. b. Criteria for Satisfactory Reporting for the 2015 Payment Adjustment for Eligible Professionals and Group Practices using the Ad ministrative Claims-based Reporting Mechanism (1) Criteria for Satisfactory Reporting for the 2015 Payment Adjustment for Eligible Professionals and Group Practices using the Ad ministrative Claims-based Reporting Mechanism Unlike the traditional PQRS claims-based reporting mechanism, the administrative claims-based reporting mechanism we proposed doe s not require an elig ible professional to submit quality data codes (QDCs) on Medicare Pa rt B claims (77 FR 44825). Rather, using the administrative claims-based reporting mechanism onl y requires that an eligible professional or group practice submit Medicare claims to CMS. Since CMS, rather than the eligible professional or group practice, is performing the analysis a nd collecting the data pr ovided in an eligible professional’s or group practice’ s Medicare claims for an el igible professional’s or group practice’s Medicare beneficiaries, we believe it is appropriate to pr opose a reporting threshold that is more stringent than that proposed fo r the 2013 and 2014 incentives that use traditional PQRS reporting mechanisms. Therefore, we pr oposed the following criteria for satisfactory reporting for the 12-month repor ting periods for the 2015 and 2016 payment adjustments (that occur in 2013 and 2014 respectively) for eligible professionals and gr oup practices using the administrative claims-based reporting mechanism: Report ALL measures in Table 63 of the proposed rule for 100 percent of the cas es in which the measures apply. Section 1848(m)(3)(C) requires that the cr iterion for group reporti ng use a statistical sampling model, such as the model used in the PGP demonstration. We noted that, although these criteria depart from the model used in th e PGP demonstration, simila r to our arguments for949 the satisfactory reporting criteria we proposed for group practic es using the claims, registry, and EHR-based reporting mechanisms, we believe that th ese criteria would still meet the statistical sampling model requirement in that the group pract ices would still be re quired to report the measures on a sample of their patients. We not ed that, with these proposed criteria, the group practice would provide claims da ta to CMS on 100 percent of its patients for which the measure applies. We note that although reporting on 100 pe rcent of patients is not a sample, for data collection purposes, CMS would only collect data on the group practice’s pa tients to which the administrative claims measures apply. Therefor e, the applicable measures will determine the sample size for which the group would report. Since the group practice is then only providing information on its applicable patients, we believe these reporting criteria would still meet the statistical sampling model requirement. We invited public comment on these proposed criteria for eligible professionals and group practices using the administ rative claims-based reporting m echanism. The following is a summary of comments received on these proposed criteria.
Comment : Several commenters supported our propos ed criteria for the administrative claims-based reporting option for the 2015 and 2016 PQRS payment adjustments. Response : We thank the commenters for their feedback. For the reasons we stated for not finalizing availability of the administrative claims-based reporting mechanism for the 2016 PQRS payment adjustment, we are finalizing the satisfactory reporting criteria for the administrative claims-based reporting option for the 2015 PQRS payment adjustment only.
Comment : One commenter sought clar ification on the reporting threshold for eligible professionals and group practices using the ad ministrative claims-based reporting option. Specifically, the commenter sought clarificat ion on how eligible professionals and group practices would be assessed under the proposed re quirement to report on all measures available950

under the administrative claims-bas ed reporting option, particularly for those patients for whom not all of the administrative claims measures apply. Response : Unlike the traditional claims, registry, EHR, or GPRO web interface reporting mechanisms, where an eligible professional or gr oup practice is not required to submit reporting G-codes to submit data on quality measures, CMS will calculate the administrative claims measures on behalf of the eligible professional or group practice, therefore reducing the chance that a reporting error would occur. For those e ligible professionals and group practices for which not all of the administrative claims measures apply to the patients of the e ligible professionals or group practices, CMS would report zero percent performance rates for these measures, meaning that a certain clinical quality action was not performed because it did not apply to a certain patient. Please note that this ad ministrative claims reporting option will be analyzed in the same manner as it will be analyzed under the Value-based Payment Modifier.
Comment : One commenter recommended that eligible professionals be allowed to choose the administrative claims-based reporting option to meet the crit eria for satisfactory reporting for the 2013 and 2014 PQRS incentives. Response : We respectfully disagree. We believe that eligible professionals and group practices should be held to a higher standard of reporting for the PQRS incentive vs. the PQRS payment adjustment. As noted previously, we agree with other commenters that the administrative claims-based reporting option may not al ways provide data that is as relevant to a practice as the data that woul d otherwise be provided from reporting measures using the traditional reporting mechanisms. We proposed th e administrative claims-based reporting option primarily as a means to report for the 2015 and 2016 PQRS payment adjustments to ease eligible professionals into reporting PQRS measures. In fact, we are not finalizing the administration claims-based reporting option for the 2016 PQRS paym ent adjustment at this time. Since we see951 this option as temporary, only a limited set of measures were proposed for use under the administrative claims-based reporting option. We believe that more meaningful data will be collected using the traditional claims, regist ry, EHR, or GPRO web interface reporting mechanisms, where eligible professionals or gr oup practices may choose measures from a broad set that may be more relevant to their practice and where we are ab le to collect richer data than what is routinely submitted for billing purposes . Therefore, eligible professionals and group practices will not be able to use the admini strative claims-based reporting mechanism for the 2013 and 2014 PQRS incentives. However, should an eligible professional or group practice elect to use the administrative claims-based reporting mechanism for the 2015 PQRS payment adjustment, please note the eligible professi onal or group practice may use the traditional reporting mechanisms for the 2013 PQRS incentive.
Comment : One commenter stated that the admini strative claims-based reporting option may not produce meaningful data. However, the commenter understands the need to balance our goal of increasing participation with our goal to collect meaningful data. Response : We agree with the commenter that da ta collected using our traditional PQRS reporting options (using the claims, registr y, EHR, and GPRO web interface reporting mechanisms) would provide more meaningful da ta. As such, we believe the administrative claims-based reporting option should be tempor ary, and we intend to move away from the administrative claims-based reporting option. Th erefore, we are only finalizing it for the 2015 PQRS payment adjustment. We believe that pr oviding this option for e ligible professionals during the first year of the implementation of th e PQRS payment adjustment will provide eligible professionals with enough time to transition into using a traditional PQRS reporting mechanism. In addition, when developing proposals fo r reporting criteria for the 2015 and 2016 PQRS payment adjustments, we considered sati sfactory reporting options that would encourage952 eligible professionals and group practices to report for the 2013 and/or 2014 incentives but, should eligible professionals or group practi ces come up shy of meeting the 2013 and/or 2014 incentive reporting criteria, would still allow an eligible professional to meet the criteria for satisfactory reporting for the 2015 and/or 2016 paym ent adjustments (77 FR 44825). In lieu of more lenient satisfactory re porting criteria we proposed for the 2015 and 2016 payment adjustment, for example, to report at least 1 measure or measures group or to elect the administrative claims-based reporting option, we considered the option of defaulting those eligible professionals who report but fail to meet the criteria for satisf actory reporting using the proposed criteria for the 2013 and/or 2014 incen tives to the administ rative claims-based reporting option. We would therefore analyze the cl aims of all eligible professionals who report at least 1 measure under a tr aditional reporting method dur ing the respective 2015 and 2016 payment adjustment reporting periods under the administrative claims-based reporting option. We considered this proposal because it is our in tention to encourage elig ible professionals to report PQRS measures using the proposed re porting criteria for the 2013 and 2014 PQRS incentives. However, given our concern abou t new eligible professionals’ familiarity and experience with the program, we stated that we felt it was necessary to propose an alternative, less stringent reporting option. We invite public comment on this alternat ive, and the following is a summary of the comments we received.
Comment : One commenter opposed defaulting eligib le professionals who do not meet the criteria for satisfactory reporting for the 2013 an d/or 2014 PQRS incentives to the administrative claims-based reporting option. The commenter notes that the proposed measures under the administrative claims-based reporting option are not broadly applicable to all medical specialties and do not encourage the reporting of PQRS measur es that are applicable to their patients.953
Response : We understand the limitations of the proposed administrative claims-based reporting option, particularly as it applies to certain spec ialties. Based on the comments received and our desire to encourage eligib le professionals to report measur es applicable to the eligible professionals' practice, we are not finalizing a policy to default e ligible professionals who do not meet the criteria for satisfactory reporting for the 2013 and/or 2014 PQRS incentives to the administrative claims-based reporting option.
Comment : One commenter supported defaulting eligible professionals who do not meet the criteria for satisfactory reporting for the 2013 and/or 2014 PQRS incentives to the administrative claims-based reporting option. The commenter noted that should CMS default eligible professionals to the administrative clai ms-based reporting option, registration would not be necessary. Response : Although we disagree, we a ppreciate the commenter’s feedback. As eligible professionals and group practices choose the tr aditional reporting mechanisms under which they report PQRS quality measures, we are requiring e ligible professionals to affirmatively choose whether or not to elect the administrative clai ms reporting option. We emphasize our preference towards the traditional claims, registry, EH R, and GPRO web in terface PQRS reporting mechanisms. In summary, eligible professionals and gr oup practices have 3 options for meeting the criteria for satisfactory reporting for the 2015 PQRS payment adjustment:

• Meet the criteria for the 2013 PQRS incentive;;

• Report 1 applicable measure or , for eligible professionals only, measures group; or

• Elect to be analyzed under the administ rative claims-based reporting mechanism. Eligible professionals and group practices have 1 option for meeting the criteria for satisfactory reporting for the 2016 PQRS payment ad justment: meet the criteria for satisfactory954 reporting for the 2016 PQRS payment adjustment. c. Analysis of Eligible Professionals a nd Group Practices who will be Assessed a PQRS Payment Adjustment As noted in §414.90(b), an eligible professiona l is assessed at the TIN/NPI level and a group practice selected to participate in the GPRO is assessed at the TIN level. As there is a 1- year lapse in time between the end of a proposed respective payment adjustment reporting period and when an eligible professional is expected to receive a PQRS payment adjustment for not meeting the requirements for satisfactory report ing for the respective payment adjustment, we understand that an eligible professional may cha nge his or her TIN/NPIs during this lapse of time. Likewise, a group practice selected to par ticipate in the GPRO may change its TIN during this lapse in time. In the proposed rule (77 FR 44825-44826). We noted that we believed this could raise issues with regard to the subseque nt application of the payment adjustment and concerns about the potential for abuse (f or example, “gaming the system”). Accordingly, we invited public comment this issue, including what parameters, if any, CMS should impose regarding the changes in TIN/NPIs and compositions of group practices with regard to the payment adjustment. We received the following comment regarding this issue.
Comment : One commenter disagreed with our c oncern for potential abuse for allowing changes in an eligible professional's TIN/ NPI composition for applying the PQRS payment adjustment. The commenter stated that actu al reporting of PQRS m easures is typically documented by the practice's administrative staff, not the eligible professional. Therefore, should an eligible professional decide to enter a new practice, the eligible professional should not be held accountable for errors that occurred in his or her prev ious practice. The commenter stated that having a PQRS payment follow the elig ible professional into a potential new practice955 could affect the eligible professiona l's ability to seek new employment. Response : It is not CMS' intention to affect the employment opport unities of eligible professionals by establishing parameters concer ning changes in an elig ible professional's TIN/NPI composition for applying the PQRS pa yment adjustment. Rather, CMS' concern regarding changes in an eligible professionals TIN/NPI combination lie in the potential that an eligible professional may change his/her TIN/NPI composition solely for the purpose of avoiding application of the PQRS payment adjustment. After taking into cons ideration the comment received, at this point, we are not placing any parameters aro und the changing of an eligible professional's TIN/NPI composition for purposes of the payment adjustment. However, we may place such parameters in the future should the need arise. 6. PQRS Quality Measures for 2013 and Beyond This section focuses on the PQRS quality meas ures we are making available for reporting under PQRS using the claims, registry, EHR (direct EHR or EHR data submission vendor product), GPRO web interface, and/or administ rative claims-based reporting mechanisms. Below, we address the comments we received re garding these measures. We note, however, that many commenters provided comments related to measure specifications and suggestions for additional measures. For the measure specifica tions for these proposed PQRS measures, please note that we do not use the rulemaking process to change measure specifications. Measure specifications are determined by the measure deve lopers and owners. Therefore, suggestions on changes to measure specifications should be ad dressed to the respective measure developer and/or owner. In addition, we note that we received some comments in which commenters suggested additional measures. However, as we have noted in prior program years, we do not generally adopt measures in the final measure set that we re not proposed in the pr oposed rule (though we956 do taken them in consideration for possible use in future years of the program). In addition, we note that we undergo a pre-rulemaking process – in cluding the requirement that measure owners and developers submit these measures for incl usion in the PQRS meas ure set in our annual PQRS Call for Measures and have these measures subsequently reviewed by the MAP – prior to proposing measures in rulemaking. Since thes e proposed measures have not gone through our various vetting channels, we cannot include these newly suggested measures that arise from the comments provided. We also received comments asking whethe r PQRS measures applied to certain specialties. Please note that th ese questions are not typically a ddressed in rulemaking. We urge the commenters to contact the QualityNet Help Desk for assistance with finding applicable

measures. a. Statutory Requirements for the Selecti on of PQRS Quality Measures for 2013 and Beyond Under section 1848(k)(2)(C)(i) of the Act, the PQRS quality measures shall be such measures selected by the Secret ary from measures that have b een endorsed by the entity with a contract with the Secretary under subsection 1890(a) of the Act (currently, th at is the National Quality Forum, or NQF). However, in the case of a specified area or medical topic determined appropriate by the Secretary for which a feasible and practical measure has not been endorsed by the NQF, section 1848(k)(2)(C)(ii) of the Act authorizes the Secret ary to specify a measure that is not so endorsed as long as due consideration is given to measures that have been endorsed or adopted by a consensus organization identified by the Secretary, such as the AQA alliance. In light of these statut ory requirements, we believe that, except in the circum stances specified in the statute, each PQRS quality measure must be endorsed by the NQF. Additionally, section 1848(k)(2)(D) of the Act requires that for each PQRS quality measure, "the Secretary shall957 ensure that eligible pr ofessionals have the opportunity to pr ovide input during the development, endorsement, or selection of measures applicable to services they furnish." The statutory requirements under section 1848 (k)(2)(C) of the Act, subject to the exception noted previously, require only that the measures be sele cted from measures that have been endorsed by the entity with a contract with the Secretary under section 1890(a) (that is, the NQF) and are silent for how the measures that are submitted to the NQF for endorsement were developed. The basic steps for developing measures applicable to physicians and other eligible professionals prior to submission of the meas ures for endorsement may be carried out by a variety of different organizations. We do not believe there needs to be any special restrictions on the type or make-up of the organizations carry ing out this basic proc ess of development of physician measures, such as restricting the initial development to physician-controlled organizations. Any such restriction would unduly limit the basic development of quality measures and the scope and utility of measures that may be considered for endorsement as voluntary consensus standards fo r purposes of the PQRS. In addition to section 1848(k )(2)(C) of the Act, section 1890A of the Act, which was added by section 3014(b) of the Afford able Care Act, requires that th e entity with a contract with the Secretary under subsection 1890(a) of the Act (currently that, is the NQF) convene multistakeholder groups to provide input to the Secr etary on the selection of certain categories of quality and efficiency measures. These categories are described in section 1890(b)(7)(B) of the Act, and include such measures as the quality measures selected for reporting under the PQRS. Pursuant to section 3014 of Affordable Care Act, the NQF convened multi-stakeholder groups by creating the Measure App lications Partnership (MAP). Sect ion 1890(A)(a) of the Act requires that the Secretary establish a pr e-rulemaking process in which th e Secretary must make publicly available by December 1 st of each year a list of the quality and efficiency measures that the958 Secretary is considering for selection through ru lemaking for use in the Medicare program. Once we have made this list available to the pub lic, the NQF must provide CMS with the MAP’s input on selecting measures by February 1 st of each year. The lis t of measures the under consideration for 2012 is available at http://www.qualityforum.org/Sett ing_Priorities/Partnership/Meas ure_Applications_Partnership.a
spx
. We received the following comments regarding these statutory requirements for the selection of PQRS quality measures:
Comment : One commenter was concerned with the requirement that all measures included in PQRS be NQF-endorsed. Response : As we discussed above, section 1848(k)(2 )(C)(i) of the Act generally requires that the PQRS quality measures be NQF e ndorsed. However, we note that section 1848(k)(2)(C)(ii) of the Act aut horizes CMS to include measures in PQRS that are not NQFendorsed. PQRS gives preference to measures that have been endorsed byNQF. However, there are cases where no NQF measures exist which addr ess an identified quality area. Additionally, PQRS measures undergo yearly revisions based on NQF and meas ure owner direction, which incorporate new evidence a nd clinical recommendations.
Comment : Some commenters believed that only measures that are NQF-endorsed should be available for reporting in PQRS. Response : We understand the importance of NQF e ndorsement. While we appreciate the commenters' feedback, we believe there are circ umstances (such as when a measure addresses a gap in the PQRS measure set) where we may beli eve that it is important to include a non-NQF endorsed measure to be available for reporting under PQRS. Section 184 8(k)(2)(C)(ii) of the Act authorizes the Secretary to include measures available for reporting under PQRS that are not959
NQF endorsed. We believe that the measures we finalize under PQRS undergo a vetting process. For example, prior to rule making, CM S reviews input from the Measure Applications Partnership (MAP). Among other factors, utility , feasibility, and analy tics are assessed during this process. The Secretary has contracted with the National Quality Forum (NQF), as the consensus-based entity for a number of reasons, as described in section 1890 of the Act, including for the specific purpose of convening multi-stakeholder groups to provide input to CMS on the identification of the best available pe rformance measures and the selection of these measures for PQRS (amongst other purposes).
Comment : One commenter stressed its concern with prioritizing measures that are NQFendorsed. The commenter notes that NQF endorse ment is not achievable for all measures as staff and financial resources are limited for many measure developers, both of which are needed to deploy large testing projects to support reliability and vali dity. Moreover, the commenter believed the method of measure development for primary care differs vastly from that of specialty care due to dissimilariti es in patient populations and targ et diseases which may be more amenable to qualitative vs. quantitative research. Response : We understand the commenter's concer ns regarding the limitations of NQFendorsement and have historically included meas ures that are not NQF-e ndorsed for inclusion in the PQRS measure set based on our exception aut hority under section 184 8(k)(2)(C)(ii) of the Act. We continue to include measures that are not NQF-endorsed to address gaps in the PQRS measure set when appropriate.
Comment : One commenter requested that, in the future, CMS include more information regarding measure recommendations from the Meas ure Applications Partnership (MAP) to allow the public to more meaningfully comment on proposed PQRS measures.960
Response : We understand the need to provide the public with adequate information to meaningfully comment on our proposals. Therefore, in the future, we will seek to provide more information regarding measure r ecommendations from the MAP. b. Other Considerations for the Selection of Proposed PQRS Quality Measures for 2013 and Beyond As we noted above, section 1848(k)(2)(C)(ii) of the Act provides an exception to the requirement that the Secretary se lect measures that have been endorsed by the entity with a contract under section 1890(a) of the Act (that is, the NQF). We may select measures under this exception if there is a specified area or medical topic for which a feasible and practical measure has not been endorsed by the en tity. Under this exception, as ide from NQF endorsement, we requested that stakeholders apply the following considerations when submitting measures for possible inclusion in the PQRS measure set:

● High impact on healthcare.

● Measures that are high impact and support CMS and HHS priorities for improved quality and efficiency of care for Medicare beneficiaries.

● Measures that address gaps in the quality of care delive red to Medicare beneficiaries.

● Address Gaps in th e PQRS measure set.

● Measures impacting chronic conditions (chronic kidney disease, diabetes mellitus, heart failure, hypertension and musculoskeletal).

● Measures applicable across care setti ngs (such as, outpatient , nursing facilities, domiciliary, etc.).

● Broadly applicable measures that could be used to crea te a core measure set required of all participating eligible professionals.961

● Measures groups that reflect the services furnished to beneficiaries by a particular specialty. On October 7, 2011, we ended a Call for Meas ures that solicited new measures for possible inclusion in the PQRS for 2013 and beyond. During the Call for Measures, we solicited measures that were either NQF-endorsed or fe ll under the exception specified in section 1848(k)(2)(C)(ii) of the Act. Although the deadline to submit measures fo r consideration for the 2013 PQRS program year has ended, we invited public comment on future considerations related to the selection of new PQRS quality measures. The following is a summary of the comments received.
Comment : One commenter emphasized the need that measures selected for reporting under PQRS be vetted by multi-stakeholder en tities from development to endorsement, particularly by physicians who are ultimately the end-users of the measures. Another commenter stressed the importance of providing a better review and vetting process of measures. Response : We appreciate the commenter's feedb ack and understand the importance of ensuring that stakeholders review measures prior to being include d in PQRS, particularly during our annual PQRS Call for Measures and subseque ntly through use of the MAP’s input.
Comment : One commenter strongly supports the c ontinued development of risk-adjusted measures versus process measures as true measures of physician quality. Response : CMS agrees and will strive to in clude and implement robust outcomes measures in the PQRS measure set as appropriate measures.
Comment : One commenter urges CMS to bolster the current PQRS requirements, which rely too heavily on measures of basic competenci es and other processes th at are not necessarily close to or related to an outcome. The commente r believes that many measure gaps (particularly in the area of outcomes) must be filled for PQRS to effectively and accurately assess physician962 performance. Therefore, the commenter urges CM S to fill these gaps at the earliest opportunity by working with medical societies and other measure developers. Response : We agree with the commenter's fee dback and are actively working with stakeholders to address measure gaps in the PQRS measure set.
Comment : One commenter urged CMS to continue to develop risk adjustment methodologies as there is not a clear method to adjust many quality measures. The commenter asked CMS to support the development of measur es that better address multi-morbidity and patient centeredness. Response : We appreciate the commenter's feedback and encourage the submission of risk adjusted measures for consideration for inclusion in the PQRS measures set. c. PQRS Quality Measures This section focuses on the proposed PQRS i ndividual Measures available for reporting via claims, registry, and/or EHR-based re porting for 2013 and beyond. To align with the proposed measure domains provided in the EHR Incentive Program (77 FR 13743), we classify all proposed measures against six domains based on the National Quality Strategy’s six priorities, as follows (77 FR 44827): (1) Patient and Family Engagement

. These are measures that reflect the potential to improve patient-centered care and the quality of care delivered to patients. They emphasize the importance of collecting patient-reported data and the ability to impact care at the individual patient level as well as the population level thro ugh greater involvement of patients and families in decision making, self-care, activation, and un derstanding of their he alth condition and its effective management. (2) Patient Safety

. These are measures that reflect the sa fe delivery of clin ical services in both hospital and ambulatory settings and include processes that would reduce harm to patients963

and reduce burden of illness. These measur es should enable longitudinal assessment of condition-specific, patient-focused episodes of care. (3) Care Coordination

. These are measures that dem onstrate appropriate and timely sharing of information and coordination of c linical and preventive services among health professionals in the care team and with patients , caregivers, and families to improve appropriate and timely patient and care team communication.

 (4) Population and Public Health

. These are measures that refl ect the use of clinical and preventive services and achieve improvements in the health of the population served and are especially focused on the leading causes of mort ality. These are outcome-focused and have the ability to achieve longitudinal measurement th at will demonstrate improvement or lack of improvement in the health of the US population. (5) Efficient Use of Healthcare Resources

. These are measures that reflect efforts to significantly improve outcomes and reduce errors. These measures also impact and benefit a large number of patients and emphasize the use of evidence to best manage high priority conditions and determine appropriate use of healthcare resources. (6) Clinical Processes/Effectiveness

. These are measures that reflect clinical care processes closely linked to outcomes ba sed on evidence and practice guidelines. We invited but received no public comment on these domains. Please note that the PQRS quality measure specifications for any given proposed PQRS individual quality measure may di ffer from specifications for the same quality measure used in prior years. For example, for the proposed PQ RS quality measures that were selected for reporting in 2012, please note that detailed measur e specifications, includi ng the measure’s title, for the proposed individual PQRS quality m easures for 2013 and beyond may have been updated or modified during the NQF endorsement process or for other reasons. In addition, due to our964 desire to align measure titl es with the measure titles th at were proposed for 2013, 2014, 2015, and potentially subsequent years of the EHR In centive Program, we note that the measure titles for measures available for reporting via EHR may change. To the extent that the EHR Incentive Program updates its measure titl es to include version numbers (77 FR 13744), we intend to use these version numbers to describe the PQRS EH R measures that will also be available for reporting for the EHR Incentive Program. We will continue to work toward complete alignment of measure specifications across programs whenever possible. Through NQF’s measure maintenance process, NQF endorsed measures are sometimes updated to incorporate changes that we believe do not substantia lly change the nature of the measure. Examples of such changes could be updated diagnosis or procedure codes or changes to exclusions to the patient population or definitions. We believe these types of maintenance changes are distinct from more substantive ch anges to measures that result in what are considered new or different measures, and that they do not trigger the same agency obligations under the Administrative Procedure Act. We proposed that if the NQF updates an endorsed measure that we have adopted for the PQRS in a manner that we consider to not substantially change the nature of the measure, we would us e a subregulatory process to incorporate those updates to the measure specifications that a pply to the program (77 FR 44822). Specifically, we would revise the Specifications Manual so that it clearly identifies the updates and provide links to where additional inform ation on the updates can be found. We would also post the updates on the CM S QualityNet Website at https://www.QualityNet.org . We would provide sufficient lead time for implementing the changes where changes to the data collection systems would be necessary. We would continue to use the rulemaking proc ess to adopt changes to measures that we consider to substantially change the nature of the measure. We believe that this proposal965 adequately balances our need to incorporate NQF updates to NQF – endorsed measures in the most expeditious manner possible, while pres erving the public's ability to comment on updates that so fundamentally change an endorsed measure that it is no longer the same measure that we originally adopted.
We invite public comment on this proposal. The following is a summary of comments we received on this proposal to allow for alte ring of a measure that has been finalized in rulemaking, provided that the updates do not substa ntially change the natu re of the measure.
Comment : Some commenters opposed our proposal to handle changes to a measure through a subregulatory process. Response : We understand the need for transparen cy when effectuating changes to a measure. However, we note that the measure changes we envision making outside of rulemaking are relatively minor, such as minor changes to the measure specifications. Other examples of minor changes include: adding the NQF endorsement number to a measure, correcting faulty logic, adding or deleting codes as well as pr oviding additional implementation guidance for a measure. These changes do not substantively ch ange the measures we finalize in rulemaking. We believe it is necessary to be able to make non-substantive changes to PQRS measures, so that we may quickly address issues that arise with the reporting of measures. Therefore, we are finalizing our proposal to make non-substant ive measure changes outside of rulemaking. We note that CMS does not usually make unila teral changes to measures. These minor changes are usually addressed in collaboration with stakeholder feedback – measure developers, measure owners, eligible professi onals reporting the respective measures, etc. Therefore, to the extent that we received comments related to mi nor changes to the proposed PQRS measures, we did not address these comments in this final rule . Commenters are encouraged to contact the respective measures owners regarding these issues.966 To receive more information on the proposed measures containe d in this section, including the measure specificati ons for these proposed measures , please contact the respective measure owners. Contact information for the m easure owners of these proposed PQRS measures is available at the PQRS Website at http://www.cms.gov/Medicare/Quality-Initiatives-PatientAssessment-Instruments/PQRS/index.html

. (1) HHS Million Hearts Individual Measures Available for Claims, Qualified Registry, and EHR-based Reporting for 2013 and Beyond In 2011, the Department of Health and Human Services (HHS) starte d the Million Hearts Initiative, which is an initiative to prevent 1 milli on heart attacks and strokes in 5 years. We are dedicated to this initiative and s eek to encourage eligible professiona ls to join in this endeavor. Therefore, based on our desire to support the Million Hearts initi ative and maintain our focus on cardiovascular disease prevention, we proposed individual PQRS Core Measures that were specified in Table 94 of the CY 2013 MPFS pr oposed rule for 2013 and beyond (77 FR 44827). These measures were the same measures we finalized under the 2012 PQRS in the CY 2012 Medicare PFS final rule (76 FR 73345). Pleas e note that, although we proposed that certain measures serve as core PQRS quality measures, we did not propose to require that eligible professionals report on these proposed PQRS core measures. We invited public comment on the proposed PQRS core measures for 2013 and be yond. We did not receive public comment on the majority of measures we proposed to classify as PQRS core measures. The following is a summary of the comments we received on the proposed PQRS core measures for 2013 and beyond and our propos al regarding the “core” designation.
Comment : One commenter recommended that we avoid classifying the proposed PQRS core measures as "core measures," because th e EHR Incentive Program uses the term "core measures" differently. Therefore, the commenter st ated that classifying these PQRS measures as967 "core measures" may cause confusion. Response : We agree with the commenter that the te rm "core measures" is used differently under PQRS and the EHR Incentive Program. Theref ore, we will refer to these measures as HHS Million Hearts Measures.
Comment : One commenter supports CMS' dedi cation to view the treatment of cardiovascular conditions as a top priority. Response : We appreciate the commenter's feedbac k. Indeed, aside from finalizing our measures related to cardiovascul ar conditions, we are finalizing this proposed measure set. However, rather than referring to this measure se t as PQRS core measures, we will refer to this measure set as the measure set contai ning the HHS Million Hearts Measures.
Comment : One commenter opposed classifying the following measure as a PQRS core

measure:

• Preventive Care and Screening: Cholesterol – Fasting Low Density Lipoprotein (LDL) Test Performed AND Risk- Stra tified Fasting LDL The commenter does not believe that this measure should be a core measure because it is only available for reporting using the EHR-based reporting mechanism. Response : While this measure is only availa ble for reporting using the EHR-based reporting mechanism, the measure addresses impor tant quality actions related to the Million Hearts Initiative. Therefore, we are finalizi ng these proposed measures as part of the HHS Million Hearts measure set available fo r reporting under PQRS for 2013 and beyond. Table 94 provides a summary of the HHS Million Hearts measures we are finalizing for 2013 and beyond. Please note that, although we strongl y encourage that elig ible professionals report these measures, eligible professionals are no t required to report these specific measures for the purposes of meeting the criteria for sati sfactory reporting for the PQRS incentives or968 payment adjustments.
Table 94: HHS Million Hearts Measures for 2013 and Beyond*969

Reporting MechanismNQF/PQRSNew Measure National Quality Strategy Domain Measure Title and Description ¥Measure StewardPQRS ClaimsPQRS Qualified RegistryPQRS Qualified EHRCMS-Selected GPRO(web interface)*Measures GroupsOther Quality ReportingPrograms

0064/ 2 Clinical Process/ Effectiven ess Diabetes Mellitus: Low Density Lipoprotein (LDL-C) Control: Percentage of patients aged 18 through 75 years with diabetesmellitus who had most recent LDLC level in contro l (less than 100 mg/dL) NCQA X X X X HITECH Million Hearts

0068/ 204 Clinical Process/ Effectiven ess Ischemic Vascular Disease (IVD): Use of Aspirin or Another Antithrombotic: Percentage of patients aged 18 years and older with Ischemic Vascular Disease (IVD) with documented use of aspirin or another antithrombotic NCQA X X X X X HITECH ACO Million Hearts

0028/ 226 Population /Public Health Preventive Care and Screening: Tobacco Use: Screening and Cessation Intervention: Percentage of patients 18 years and older who were screened for tobacco use one or more times within 24 months AND who received cessation counseling intervention if identified as a tobacco user AMAPCPI X X X X X HITECH ACO Million Hearts

0018/ 236 Clinical Process/ Effectiven ess Hypertension (HTN): Controlling High Blood Pressure: Percentage of patients aged 18 through 85 years of age who had a diagnosis of hypertension (HTN) and whose BP was adequately controlled (< 140/90 mmHg) NCQA X X X X X HITECH ACO Million Hearts

0075/ 241 Clinical Process/ Effectiven ess Ischemic Vascular Disease (IVD): Complete Lipid Panel and Low Density Lipoprotein (LDL-C) Control: Percentage of patients NCQA X X X X X HITECH ACO Million Hearts970

(2) PQRS quality measures Available for Repor ting via the Claims, Qualified Registry, EHR, and GPRO Web interface Reporti ng Mechanisms for 2013 and Beyond This section contains individual PQRS quality measures we proposed for 2013 and beyond (77 FR 44830) and the final m easure set we are adopting in th is final rule with comment period. Please note that, in larg e part, we proposed to retain most of the quality measures we finalized for reporting for the 2012 PQRS (76 FR 42865 through 42872). However, in 2013 and aged 18 years and older with Ischemic Vascular Disease (IVD) who received at least one lipid profile within 12 months and whose most recent LDL-C level was in control (less than 100 mg/dL) N/A/ 316 Clinical Process/ Effectiven ess Preventive Care and Screening: Cholesterol – Fasting Low Density Lipoprotein (LDL) Test Performed AND Risk-Stratified Fasting LDL: Percentage of patients aged 20 through 79 years whose risk factors* have been assessed and a fasting LDL test has been performed *There are three criteria for this measure based on the patient’s risk category. 1. Highest Level of Risk: Coronary Heart Disease (CHD) or CHD Risk Equivalent 2. Moderate Level of Risk: Multiple (2+) Risk Factors 3. Lowest Level of Risk: 0 or 1 Risk Factor CMS/ QIP X HITECH Million Hearts

N/A/ 317 Population /Public Health Preventive Care and Screening: Screening for High Blood Pressure and Follow-Up Documented: Percentage of patients aged 18 years and older seen during the reporting period who were screened for high blood pressure (BP) AND a recommended follow-up plan is documented based on the current blood pressure reading as indicated CMS/ QIP X X X X X HITECH ACO Million Hearts971 2014, we proposed to include new measures, as well as remove measures that were available for reporting under the 2012 PQRS (not re-propose certain measures for 2013 and beyond). Table 97 of the CY 2013 PFS proposed rule contains the list of measures we proposed to be available for reporting under the PQRS for 2013 and beyond th at were available under the 2012 PQRS (77 FR 44841). Tables 30 and 33 of the CY 2013 PFS proposed rule contains the list of new measures we proposed to be available for reporting under the PQRS beginning in 2013 and 2014 respective that were not available under th e 2012 PQRS (77 FR 44831 and 77 FR 44942). Tables 31 and 34 of the CY 2013 PFS proposed rule contains the list of measures we did not propose for reporting under PQRS beginning in 2013 and 2014 respectiv ely that are available for reporting under the 2012 PQRS ( 77 FR 44837 and 77 FR 44953). General Comments on Proposed Indivi dual Measures for Reporting for 2013/2014 and Beyond . We received the following general commen ts related to the individual measures we proposed for reporting under PQRS beginning in 2013 or 2014:
Comment : Several commenters appreciate CMS' efforts to align the PQRS measures available for reporting under the EHR-based repor ting mechanisms with the measures available for reporting under the EHR Incentive Program. The commenters believe this alignment will reduce the administrative burden on eligible professionals while harmonizing the two programs. Response : We appreciate the commenter's feedb ack and note that we are working to completely align the measures available fo r reporting via EHR under PQRS and the EHR Incentive Program. For the 2012 PQRS, we have attempted to align the PQRS measures available for EHR-based reporting with the EHR measures available for reporting under the EHR Incentive Program (76 FR 73364) and we are re taining those measures for 2013 and beyond. In fact, we are adding or removing measures available for EHR-base d reporting that align with what has been finalized for reporting under th e EHR Incentive Program for beginning in CY972 2014 (77 FR 54060).
Comment : Some commenters were pleased that the proposed PQRS measure set provided a variety of measures for which certain specia lties may report, such as vascular surgeons. Response : We appreciate the commenters’ feedbac k. It is our goal to ensure that specialties are able to report under PQRS. Therefor e, as our final set of measures specified in Table 95 indicates, we allow for a broad variet y of measures in th e PQRS measure set. We note that we received several comments re lated to the addition of measures we did not propose for inclusion in PQRS. We note the need to be transparen t and provide the public with an opportunity to provide comment on the m easures we include in PQRS prior to finalizing these measures in the PQRS measure set. Sin ce we did not propose including these measures for reporting under PQRS, we are not addressing these comments in th is final rule. However, we will use the comments we have received when sel ecting measures to be included in PQRS for future program years. Prior Measures Not Proposed for Reporting under PQRS. We did not propose to retain 14 measures in 2013 that were previous ly established for repor ting under the 2012 PQRS (see Table 96 of the CY 2013 PFS proposed rule, 77 FR 44837). We did not propose to retain 9 measures in 2014 that were previously establ ished for reporting under the 2012 PQRS (see Table 34 of the CY 2013 proposed rule, 77 FR 44953). The public comments we received did not address the majority of the measures identified from prior PQRS program years that we did not propose to include from reporting under PQRS in 2013 and 2014. The following is a summary of the comments we did receive regarding prior program measures we did not propose to include under PQRS in 2013 or 2014:
Comment : Some commenters opposed our deci sion not to propose for the 2013 PQRS and beyond:973

• Chronic Wound Care: Use of Compression System in Patients with Venous Ulcers. One commenter states that the MAP recommen ded that the measure be submitted for NQF endorsement. Response : We are not retaining this measure for reporting under PQRS beginning in 2013. Indeed, as the commenter stated, the MAP recommended that this measure be submitted for NQF endorsement. Currentl y, this measure is not-NQF endor sed. We interpret the MAPs recommendation that this measure be submitted for NQF endorsement as the MAP not recommending this measure until the measure is NQF endorsed. As such, according to the MAP recommendation, we are not retaining this m easure for reporting under PQRS. However, we may consider including this measure for reporti ng under PQRS in future years should this measure later receive NQF endorsement. We note th at it is the responsib ility of the respective measure owners and developers to submit measures for NQF endorsement.
Comment : Some commenters opposed our proposal not to retain the following measure for reporting under PQRS:

• Health Information Technology (HIT): Adoptio n/Use of Electronic He alth Records (EHR) One commenter suggested that this measure be retained until a majority of eligible professionals have adopted EHR systems. Anot her commenter disagreed with CMS’ contention that this measure is redundant to have an elig ible professional report on whether or not s/he has adopted an EHR. The commenter believed that the measure is only redu ndant in the instances where the eligible professional is using direct EHR reporting. The commenter suggested that CMS follow the same protocol as other PQRS measures by designating measure #124 available only to those eligible professional who re port using claims or registry reporting. Response : We appreciate the commenter's feedb ack, but we are not retaining this measure for reporting under PQRS. It is our inte ntion to align the measures available for EHR-974 based reporting under PQRS with the measures available for reporting under the Medicare EHR Incentive Program. Since this measure is not available for reporting und er the EHR Incentive Program, we do not believe it is appropriate to include in the final PQ RS measure set. With respect to the commenter’s request that th is measure be retained until a majority of eligible professionals have adopt ed EHR systems, we do not believe we need to retain this measure for reporting for this purpose as we are encouraging eligible prof essionals to adopt EHR systems in other ways. For example, we are al igning our EHR reporting crit eria with the criteria for meeting the CQM component of meaningful use such that el igible professionals reporting quality measures data via an EHR may satisfy the requirements for satis factory reporting under PQRS and achieving meaningful use under the EHR Incentive Program by submitting one set of data. With respect to the commenter who disagr eed that the measure is redundant, we respectfully disagree with the commenter. Measur es in PQRS generally pr ovide that the eligible professional perform some sort of clinical quality action. For example, with respect to the HHS Million Hearts measure set that we are finalizi ng, the measure set indicates that an eligible professional asks certain questions of benefici aries and perform certai n procedures that we believe would help prevent heart disease. Th is measure does not do th is; rather, the measure merely asks the eligible profe ssional in indicate to CMS whether or not the eligib le professional has adopted an EHR system. We do not believe this measure provides meaningful information to CMS anymore, as there are other PQRS requirements and CMS programs that more appropriately address the adoption and use of EHR systems. For these reasons, we will not extend the reporting of this measure for claims or registry-based reporting as the commenter requested.
Comment : One commenter opposed our decision not to include the following measure for975 reporting under PQRS:

• Stroke and Stroke Rehabilitation: Comput ed Tomography (CT) and Magnetic Resonance Imaging (MRI) Response : We respectfully disagree with the comm enter. This measure was reviewed by the MAP and not recommended for inclusion in the PQRS measure set beginning 2013. Therefore, we are following the MAP’s recomm endation and excluding this measure from reporting in PQRS beginning in 2013.
Comment : One commenter opposed our decision not to retain the following measure from reporting under PQRS:

• Coronary Artery Disease (CAD): Symptom and Activity Assessment The commenter is concerned that this meas ure is paired with PQRS Measure #242 (CAD: Symptom Management), and therefore should be re main in PQRS for reporting to coincide with the reporting of measure #242. Response : This measure was part of a two-part measure paired with Measure #242 for the 2012 PQRS. The two measures were intended to re flect the quality of services provided for the primary management of patient s with CAD who are seen in the ambulatory setting. For 2012, the PQRS measure specifications (a vailable on the PQRS website at http://www.cms.gov/apps/ama/license.asp?file=/ PQRS/downloads/2012_PhysQualRptg_Individ ualClaimsRegistry_Specs_SupportingDocs_01162012.zip ) note that, should an eligible professional assess angina symptoms and patient activity under this meas ure, then Measure #242 should also be reported. As such, this m easure triggered the reporting of Measure #242. We prioritize the recommendation the MAP provi des for the inclusion of measures in the PQRS measure set over our desi re to retain the manner we ha ve suggested that eligible professionals reporting these CAD measures in 2012. Since this measure was reviewed by the976

MAP and not recommended for inclusion in th e PQRS measure set beginning 2013, we are not retaining this measure for reporting in PQRS. Measure #242 will therefore be reportable as a standalone measure. The description on how to report Measure #242 will be found in the Measures Specifications Manual that will be pub lished for 2013 that will be available on the PQRS website at http://www.cms.gov/Medi care/Quality-Initiatives-Patient-AssessmentInstruments/PQRS/index.html.
Comment : One commenter opposed our proposal to remove the following measure from reporting under PQRS:

• Emergency Medicine: Community-Acquired Pneumonia (CAP): Assessment of Oxygen Saturation Response : The MAP recommended that this measure be “removed” from the PQRS measure set. Although we are not bound by th e recommendations of the MAP, we find no reason to oppose the MAP’s recommendation and re tain this measure fo r reporting in PQRS. Therefore, we are not retaining this meas ure for reporting in PQRS beginning in 2013.
Comment : One commenter opposed our proposal to remove the following measure from the PQRS measure set:

● Referral for Otologic Evaluation for Pa tients with Acute or Chronic Dizziness. The commenter urged CMS to consider re tiring Measure 188: Referral for Otologic Evaluation for Patients with Conge nital or Traumatic Deformity of the Ear in lieu of retiring Measure 190: Referral for Otologic Evaluation fo r Patients with Acute or Chronic Dizziness, because Measure 100 relates to a relatively unc ommon condition seen in audiology practices. Response : Although we are not bound by the MAP’ s recommendation, we note that the MAP recommended that this measure be “removed” from reporting under PQRS. We agree with the MAP’s recommendation. We believe that this measure is too low bar as it is not a high977 impact measure that provides analysis on the pa tient or provider level. Rather, the measure simply asks whether a beneficiary has been refe rred for an evaluation. Therefore, we are not retaining this measure for repor ting in PQRS. However, we encourage the development of a similar, more robust measure related to Otologic services.
Comment : Commenters supported our decision not to retain the following measure from reporting under PQRS:

• Emergency Medicine: Community-Acquired Pn eumonia (CAP): Assessment of Mental
Status

• Heart Failure: Patient Education

• Hypertension (HTN): Plan of Care

• Hypertension (HTN): Blood Pressure Measurement

• Prostate Cancer: Three Dimensional (3D) Radiotherapy

• Heart Failure: Warfarin Therapy fo r Patients with Atrial Fibrillation

• Preventive Care and Screening: U nhealthy Alcohol Use – Screening Response : We appreciate the commenter’s feedback. These measures will not be included in the PQRS measure set for 2013 or 2014 and beyond. Individual Measures Available for Reporting under PQRS . Table 97 of the CY 2013 PFS proposed rule contains the list of measures we proposed to be available for reporting under the PQRS for 2013 and beyond that were availa ble under the 2012 PQRS (77 FR 44841). Tables 30 and 33 of the CY 2013 PFS proposed rule contains the list of new measur es we proposed to be available for reporting under the PQRS be ginning in 2013 and 2014 resp ective that were not available under the 2012 PQRS (77 FR 44831 a nd 77 FR 44942). We proposed a total of 212 measures for available for reporting beginni ng in 2013. Beginning 2014, we proposed that 210 measures be available for reporting under PQRS . As indicated previ ously, these proposed978 measures are classified under 6 domains: (1) pati ent safety, (2) patient and family engagement, (3) care coordination, (4) clinical process/eff ectiveness, (5) population/public health, and (6) efficiency. With respect to the individual measures we proposed to include for reporting in PQRS beginning in 2013 or 2014, we did not receive public comments on a majority of the measures we proposed for inclusion in PQRS (specifi c measures we did receive comments on are addressed below). Therefore, based on the reasons previously stated in the CY 2013 PFS proposed rule, we are finalizing these measures, as proposed. Th ese measures either meet the requirement that the measures available in the PQRS measure set be NQF endorsed or address an exception to NQF endorsement, such as filling a ga p in the PQRS measure set. The following is a summary of the comments we did receiv e on certain proposed i ndividual measures:
Comment : Commenters provided general support for the following measures that are available for reporting in PQRS in 2012:

• Melanoma: Coordination of Care -- The inclus ion of this measure would expand the number of measures relevant to dermatologists

• Melanoma: Continuity of Care – Recall Syst em -- The inclusion of this measure would expand the number of measures relevant to dermatologists

• Melanoma: Overutilization of Imaging Studies in Melanoma -- The inclusion of this measure would expand the number of measures relevant to dermatologists For the following measures, one commenter supported the following proposed measures for inclusion in PQRS as they ar e relevant to ophthalmologists:

• Age-Related Macular Degeneration (A MD): Dilated Macu lar Examination.

• Diabetic Retinopathy: Documentation of Pres ence or Absence of Macular Edema and Level of Severity of Retinopathy979

• Diabetic Retinopathy: Communi cation with the Physician Managing On-going Diabetes
Care. One commenter applauds the decision to incorporate the following measures for reporting in PQRS:

• Cardiac Stress Imaging Not Meeting Appropriate Use Criteria: Preoperative Evaluative in Low-Risk Surgery Patients.

• Cardiac Stress Imaging Not Meeting Appropriate Use Criteria: Routine Testing After Percutaneous Coronary Intervention (PCI).

• Cardiac Stress Imaging Not Meeting Appropriate Use Criteria: Testing in Asymptomatic, Low-Risk Patients. The commenter believes these measures co llect data on three most common areas on inappropriate imaging, allowing CMS to more accurately capture information on the overall value of cardiac diagnostic imagi ng for beneficiaries. Another commenter specifically supported the measure titled “Cardiac Stress Imaging Not Meeting Appropriate Use Criteria: Testing in Asymptomatic, Low-Risk Patients.” Response : We agree with the commenters’ feedb ack and are therefore finalizing these individual measures for reporti ng in PQRS beginning in 2013 or 2014. Since these measures were available for reporting in 2012, we are re taining these measures so that eligible professionals may continue to report on these measures.
Comment : Commenters provided support for the following measures that we proposed to add to the PQRS measure set beginning in 2013:

• Participation by a Hospital, Physician or Other Clinician in a Systematic Clinical Database Registry that Includes Consensus Endorsed Quality980

• Atrial Fibrillation and Atrial Flutter: Chronic Anticoagula tion Therapy -- The commenter also requested that the measure owner info rmation on this measure should be updated to indicate that AMA-PCPI/ACCF/AHA is the current measure owner.

• Pediatric Kidney Disease: Adequacy of Vo lume Management -- The commenter also requested that the measure owner information on this measure should be updated to indicate that AMA-PCPI is the current measure owner. Response : We appreciate the commenters’ support for adding these measure and, for the reasons stated in the CY 2012 PFS proposed rule (76 FR 44956), are finalizing these measures for reporting under PQRS for 2013 and beyond. For the measure “Atrial Fi brillation and Atrial Flutter: Chronic Anticoagulation Therapy,” we will reflect that the measure owner for this measure is currently AMA-PCPI/ACCF/AHA. Fo r the measure “Pediatric Kidney Disease: Adequacy of Volume Management,” we will reflect that the measure owner for this measure is currently AMA-PCPI.
Comment : One commenter supported our proposa l to include the following measure:

• Adult Major Depressive Disord er (MDD): Coordination of Care of Patients with Co-morbid Conditions However, the commenter opposed our proposal that this measure be pair ed, since the measure owner did not support the followi ng second part of the measure: “who have a follow-up attempt within 60 days of original communication by th e physician treating MDD to elicit a response from the other physician.” Response : We appreciate the commenter’s feed back. However, this measure was submitted for consideration for inclusion in the PQRS measure set as a paired measure. Since we usually defer to the respective measures owne rs and developers on how a particular measure should be reported, we are finalizi ng this measure, as proposed.981

Comment : One commenter urged CMS to consider retiring the following measure:

• Referral for Otologic Evaluation for Patients with Congenital or Traumatic Deformity of the
Ear. The commenter requests retiring this measur e in lieu of retiring Measure 190: Referral for Otologic Evaluation for Patie nts with Acute or Chronic Dizziness, because Measure 100 relates to a relatively uncommon co ndition seen in audiology practices. Response : We appreciate the commenter’s feedb ack. According to the 2012 PQRS and eRx Experience Report, we note that no eligible professionals satisf actorily reported this measure. Since eligible professionals attemp ting to report this measure have had difficulty historically with reporting this m easure, we are finalizing our deci sion not to retain this measure for reporting under PQRS.
Comment : Some commenters requested that the following measure be reclassified from the NCQA domain "Clinical Process/Effectivenes s" to the "Care Coordination" domain:

• Diabetic Retinopathy: Communication with the Physician Managing On-going Diabetes Care Since the activity addressed in the measure re lates to communication and coordination with diabetes patients, the measure is more appropriate ly classified in the Care Coordination domain. Response : We appreciate the commenters' feedback. We agree with the commenters that the actions indicated in this measure involve coordination between patients and physicians. We understand that measures may pertain to multiple domains. However, as the EHR Incentive Program has also classified this as a clinical process/effectiveness measure (77 FR 54071), we are retaining the classifying this measure as a c linical process/effectiveness measure. We will, however, consider changing the classification of this measure in the future.
Comment : One commenter supported our proposal to include an Osteoporosis composite measure but suggested that a sub-measure ("Os teoporosis: Management Following Fracture of982 Hip, Spine or Distal Radius for Men and Wome n Aged 50 Years and Older") be added to the Osteoporosis composite measure owned by ABIM. Response : We appreciate the commenter's feedb ack and are finalizing the Osteoporosis composite measure for inclusion in the PQRS measur es set. However, we are not finalizing this measure under the individual measures set. Rather , this composite measure is being finalized as a measures group as specified in Table 119 because we believe that composite measures are reported more similarly to measures groups under which an eligible prof essional must report on a group of interrelated measures. Please note that the addition of sub-measures is determined by the measure owner, ABIM. The sub-measure suggested for inclusion under the Osteoporosis measure ("Osteoporosis: Management Following Fr acture of Hip, Spine or Distal Radius for Men and Women Aged 50 Years and Older") is owned by AMA. While we agree that postfracture care is an important com ponent of quality related to Oste oporosis care, we are unable to add components to composite measur es owned by outside entities.
Comment : One commenter opposed our proposal to include the following measures for reporting in PQRS, as the measure owners will no longer support these measures:

• Stroke and Stroke Rehabilitation: Tissue Pl asminogen Activator (t-PA) Considered (Paired Measure)

• Stroke and Stroke Rehabilitation: Tissue Plasminogen Activator (t -PA) Administered Initiated (Paired Measure)

• Coordination of Care of Patients with Co-M orbid Conditions – Timely Follow-Up (Paired Measure) Response : We agree with the commenter and are therefore not finalizing these measures for reporting under PQRS. Please note that we are making the following changes to certain proposed measures for983 the following reasons:

• Chronic Obstructive Pulmonary Disease (COP D): Bronchodilator Therapy – The measure owner updated the threshold of an FEV1/FVC less than 70 percent to 60 percent based on scientific evidence/clinical trials

• Colon Cancer: Chemotherapy for AJCC Stage III Colon Cancer Patients – The measure owner updated the age criteria fo r this measure to 18 to 80

• Adult Major Depressive Disord er (MDD): Comprehensive Depr ession Evaluation: Diagnosis and Severity – The measure owner has added an assessment of depression severity to this

measure

• Oncology: Cancer Stage Documented – The me asure owner has broadened the denominator for this measure

• Melanoma: Overutilization of Imaging Studi es in Melanoma – The measure owner has incorporated cancer staging into this measure

• Radiation Dose Optimization – The measure owner has updated this measure title to “Optimizing Patient Exposur e to Ionizing Radiation” A list of the measures we are finalizing fo r PQRS beginning in 2013 or 2014 is contained in Table 95. Please note that th e titles of the measures may ch ange slightly from CMS program and/or CMS program year based on specifications updates. We intend to continue to work toward complete alignment of measure specif ications across programs whenever possible. Table 95: Individual Quality Measures for the Physician Quality Reporting System Proposed to be Available for Reporting via Claims, Registry, EHR, or GRPO Web Interface Beginning in 2013 or 2014*NQF/PQRSbe National Quality Measure Title and Description ¥asureStewar Reporting MechanismalityReporting984PQRS ClaimsPQRS Qualified RegistryPQRS Qualified EHRCMS-Selected GPRO (webinterface)*Measures Groups

0059/ 1 Clinical Process/ Effective ness Diabetes Mellitus: Hemoglobin A1c Poor Control: Percentage of patients aged 18 through 75 years with diabetes mellitus who had most recent hemoglobin A1c greater than 9.0% NCQ A X X X X X MU1/ MU2 ACO

0064/ 2 Clinical Process/ Effective ness Diabetes Mellitus: Low Density Lipoprotein (LDL-C) Control: Percentage of patients aged 18 through 75 years with diabetes mellitus who had most recent LDL-C level in control (less than 100 mg/dL) NCQ A X X X X MU1/ MU2 Million Hearts

0061/ 3 Clinical Process/ Effective ness Diabetes Mellitus: High Blood Pressure Control: Percentage of patients aged 18 through 75 years with diabetes mellitus who had most recent blood pressure in control (less than 140/90 mmHg) NCQ A X X X X MU1

0081/ 5 Clinical Process/ Effective ness Heart Failure: AngiotensinConverting Enzyme (ACE) Inhibitor or Angiotensin Receptor Blocker (ARB) Therapy for Left Ventricular Systolic Dysfunction (LVSD): Percentage of patients aged 18 years and older with a diagnosis of heart failure (HF) with a current or prior left ventricular ejection fraction (LVEF) < 40% who were prescribed ACE inhibitor or ARB therapy either within a 12 month period when seen in the outpatient setting OR at each hospital discharge AMA

- PCPI/ ACC F/AH A X X X MU1/ MU2

0067/ 6 Clinical Process/ Effective ness Coronary Artery Disease (CAD): Antiplatelet Therapy: Percentage of patients aged 18 years and older with a diagnosis of coronary artery disease seen within a 12 month period who were prescribed aspirin or clopidogrel AMA

- PCPI/ ACC F/AH A X X X X MU1

0070/ 7 Clinical Process/ Effective ness Coronary Artery Disease (CAD): Beta-Blocker Therapy – Prior Myocardial Infarction (MI) or Left Ventricular Systolic Dysfunction (LVEF < 40%) : Percentage of patients AMA

- PCPI/ ACC F/AH X X MU1/ MU2985
aged 18 years and older with a diagnosis of coronary artery disease seen within a 12 month period who also have prior MI OR a current or prior left ventricular ejection fraction (LVEF) < 40% who were prescribed beta-blocker therapy A

0083/ 8 Clinical Process/ Effective ness Heart Failure: Beta-Blocker Therapy for Left Ventricular Systolic Dysfunction (LVSD): Percentage of patients aged 18 years and older with a diagnosis of heart failure (HF) with a current or prior left ventricular ejection fraction (LVEF) < 40% who were prescribed beta-blocker therapy either within a 12 month period when seen in the outpatient setting OR at each hospital discharge AMA

- PCPI/ ACC F/AH A X X X X MU1/ MU2 ACO

0105/ 9 Clinical Process/ Effective ness Major Depressive Disorder (MDD): Antidepressant Medication During Acute Phase for Patients with MDD: Percentage of patients aged 18 years and older diagnosed with a new episode of MDD and documented as treated with antidepressant medication during the entire 84-day (12-week) acute treatment phase NCQ A X X X MU1/ MU2

0086/ 12 Clinical Process/ Effective ness Primary Open Angle Glaucoma (POAG): Optic Nerve Evaluation: Percentage of patients aged 18 years andolder with a diagnosis of primary openangle glaucoma who have an optic nerve head evaluation during one or more office visits within 12 months AMA

- PCPI/ NCQ A X X X MU1/ MU2

0087/ 14 Clinical Process/ Effective ness Age-Related Macular Degeneration (AMD): Dilated Macular Examination: Percentage of patients aged 50 years and older with a diagnosis of AMD who had a dilated macular examination performed which included documentation of the presence or absence of macular thickening or hemorrhage AND the level of macular degeneration severity during one or more office visits within 12 months AMA

- PCPI/ NCQ A X X

0088/ 18 Clinical Process/ Effective ness Diabetic Retinopathy: Documentation of Presence or Absence of Macular Edema and Level of Severity of Retinopathy: Percentage of patients aged 18 years and older with a diagnosis of diabetic retinopathy who had a dilated macular or fundus exam performed which included documentation of the AMA

- PCPI/ NCQ A X X X MU1/ MU2986
level of severity of retinopathy and the presence or absence of macular edema during one or more office visits within 12 months 0089/ 19 Care Coordinat ion Diabetic Retinopathy: Communication with the Physician Managing Ongoing Diabetes Care: Percentage of patients aged 18 years and older with a diagnosis of diabetic retinopathy who had a dilated macular or fundus exam performed with documented communication to the physician who manages the ongoing care of the patient with diabetes mellitus regarding the findings of the macular or fundus exam at least once within 12 months AMA

- PCPI/ NCQ A X X X MU1/ MU2

0270/ 20 Patient Safety Perioperative Care: Timing of Prophylactic Parenteral Antibiotic – Ordering Physician: Percentage of surgical patients aged 18 years and older undergoing procedures with the indications for prophylactic parenteral antibiotics, who have an order for prophylactic parenteral antibiotic to be given within one hour (if fluoroquinolone or vancomycin, 2 hours), prior to the surgical incision (or start of procedure when no incision is required) AMA

- PCPI/ NCQ A X X X

0268/ 21 Patient Safety Perioperative Care: Selection of Prophylactic Antibiotic – First OR Second Generation Cephalosporin: Percentage of surgical patients aged 18 years and older undergoing procedures with the indications for a first OR second generation cephalosporin prophylactic antibiotic, who had an order for cefazolin OR cefuroxime for antimicrobial prophylaxis AMA

- PCPI/ NCQ A X X X

0271/ 22 Patient Safety Perioperative Care: Discontinuation of Prophylactic Parenteral Antibiotics (Non-Cardiac Procedures): Percentage of non-cardiac surgical patients aged 18 years and older undergoing procedures with the indications for prophylactic parenteral antibiotics AND who received a prophylactic parenteral antibiotic, who have an order for discontinuation of prophylactic parenteral antibiotics within 24 hours of surgical end time AMA

- PCPI/ NCQ A X X X

0239/ Patient Perioperative Care: Venous AMA X X X987
23 Safety Thromboembolism (VTE) Prophylaxis (When Indicated in ALL Patients): Percentage of surgical patients aged 18 years and older undergoing procedures for which VTE prophylaxis is indicated in all patients, who had an order for Low Molecular Weight Heparin (LMWH), Low-Dose Unfractionated Heparin (LDUH), adjusted-dose warfarin, fondaparinux or mechanical prophylaxis to be given within 24 hours prior to incision time or within 24 hours after surgery end time - PCPI/ NCQ A

0045/ 24 Care Coordinat ion Osteoporosis: Communication with the Physician Managing On-going Care Post-Fracture of Hip, Spine or Distal Radius for Men and Women Aged 50 Years and Older: Percentage of patients aged 50 years and older treated for a hip, spine or distal radial fracture with documentation of communication with the physician managing the patient’s on-going care that a fracture occurred and that the patient was or should be tested or treated for osteoporosis AMA

- PCPI/ NCQ A X X

0092/ 28 Clinical Process/ Effective ness Aspirin at Arrival for Acute Myocardial Infarction (AMI): Percentage of patients, regardless of age, with an emergency department discharge diagnosis of AMI who had documentation of receiving aspirin within 24 hours before emergency department arrival or during emergency department stay AMA

- PCPI/ NCQ A X X

0269/ 30 Patient Safety Perioperative Care: Timely Administration of Prophylactic Parenteral Antibiotics: Percentage of surgical patients aged 18 years and older who receive an anesthetic when undergoing procedures with the indications for prophylactic parenteral antibiotics for whom administration of the prophylactic parenteral antibiotic ordered has been initiated within one hour (if fluoroquinolone or vancomycin, 2 hours) prior to the surgical incision (or start of procedure when no incision is required) AMA

- PCPI/ NCQ A X X

0240/ 31 Clinical Process/ Effective Stroke and Stroke Rehabilitation: Deep Vein Thrombosis (DVT) Prophylaxis for Ischemic Stroke or AMA

- PCPI/ X X988

ness Intracranial Hemorrhage: Percentage of patients aged 18 years and older with a diagnosis of ischemic stroke or intracranial hemorrhage who were administered DVT prophylaxis by end of hospital day 2 NCQ A

0325/ 32 Clinical Process/ Effective ness Stroke and Stroke Rehabilitation: Discharged on Antithrombotic Therapy: Percentage of patients aged 18 years and older with a diagnosis of ischemic stroke or transient ischemic attack (TIA) who were prescribed antithrombotic therapy at discharge AMA

- PCPI/ NCQ A X X

0241/ 33 Clinical Process/ Effective ness Stroke and Stroke Rehabilitation: Anticoagulant Therapy Prescribed for Atrial Fibrillation (AF) at Discharge: Percentage of patients aged 18 years and older with a diagnosis of ischemic stroke or transient ischemic attack (TIA) with documented permanent, persistent, or paroxysmal atrial fibrillation who were prescribed an anticoagulant at discharge AMA

- PCPI/ NCQ A X

0243/ 35 Clinical Process/ Effective ness Stroke and Stroke Rehabilitation: Screening for Dysphagia: Percentage of patients aged 18 years and older with a diagnosis of ischemic stroke or intracranial hemorrhage who receive any food, fluids or medication by mouth (PO) for whom a dysphagia screening was performed prior to PO intake in accordance with a dysphagia screening tool approved by the institution in which the patient is receiving care AMA

- PCPI/ NCQ A X X

0244/ 36 Clinical Process/ Effective ness Stroke and Stroke Rehabilitation: Rehabilitation Services Ordered: Percentage of patients aged 18 years and older with a diagnosis of ischemic stroke or intracranial hemorrhage for whom occupational, physical, or speech rehabilitation services were ordered at or prior to inpatient discharge OR documentation that no rehabilitation services are indicated at or prior to inpatient discharge AMA

- PCPI/ NCQ A X X

0046/ 39 Clinical Process/ Effective ness Screening or Therapy for Osteoporosis for Women Aged 65 Years and Older: Percentage of female patients aged 65 years and older who have a central dual-energy X- ray absorptiometry (DXA) measurement ordered or performed at least once since age 60 or pharmacologic therapy AMA

- PCPI/ NCQ A X X X X989
prescribed within 12 months 0048/ 40 Clinical Process/ Effective ness Osteoporosis: Management Following Fracture of Hip, Spine or Distal Radius for Men and Women Aged 50 Years and Older: Percentage of patients aged 50 years and older with fracture of the hip, spine, or distal radius who had a central dual-energy X-ray absorptiometry (DXA) measurement ordered or performed or pharmacologic therapy prescribed AMA

- PCPI/ NCQ A X X

0049/ 41 Clinical Process/ Effective ness Osteoporosis: Pharmacologic Therapy for Men and Women Aged 50 Years and Older: Percentage of patients aged 50 years and older with a diagnosis of osteoporosis who were prescribed pharmacologic therapy within 12 months AMA

- PCPI/ NCQ A X X

0134/ 43 Clinical Process/ Effective ness Coronary Artery Bypass Graft (CABG): Use of Internal Mammary Artery (IMA) in Patients with Isolated CABG Surgery: Percentage of patients aged 18 years and older undergoing isolated CABG surgery who received an IMA graft STS X X X

0236/ 44 Clinical Process/ Effective ness Coronary Artery Bypass Graft (CABG): Preoperative Beta-Blocker in Patients with Isolated CABG Surgery: Percentage of isolated Coronary Artery Bypass Graft (CABG) surgeries for patients aged 18 years and older who received a beta-blocker within 24 hours prior to surgical incision CMS/ QIP X X X

0637/ 45 Patient Safety Perioperative Care: Discontinuation of Prophylactic Parenteral Antibiotics (Cardiac Procedures): Percentage of cardiac surgical patients aged 18 years and older undergoing procedures with the indications for prophylactic parenteral antibiotics AND who received a prophylactic parenteral antibiotic, who have an order for discontinuation of prophylactic parenteral antibiotics within 48 hours of surgical end time AMA

- PCPI/ NCQ A X X

0097/ 46 Patient Safety Medication Reconciliation: Percentage of patients aged 65 years and older discharged from any inpatient facility (e.g., hospital, skilled nursing facility, or rehabilitation facility) and seen within 30 days following discharge in the office by the physician providing on-going care who had a reconciliation of the discharge AMA

- PCPI/ NCQ A X X X ACO990

medications with the current medication list in the outpatient medical record documented 0326/ 47 Care Coordinat ion Advance Care Plan: Percentage of patients aged 65 years and older who have an advance care plan or surrogate decision maker documented in the medical record or documentation in the medical record that an advance care plan was discussed but the patient did not wish or was not able to name a surrogate decision maker or provide an advance care plan AMA

- PCPI/ NCQ A X X X

0098/ 48 Clinical Process/ Effective ness Urinary Incontinence: Assessment of Presence or Absence of Urinary Incontinence in Women Aged 65 Years and Older: Percentage of female patients aged 65 years and older who were assessed for the presence or absence of urinary incontinence within 12 months AMA

- PCPI/ NCQ A X X X X

0099/ 49 Clinical Process/ Effective ness Urinary Incontinence: Characterization of Urinary Incontinence in Women Aged 65 Years and Older: Percentage of female patients aged 65 years and older with a diagnosis of urinary incontinence whose urinary incontinence was characterized at least once within 12 months AMA

- PCPI/ NCQ A X X

0100/ 50 Patient and Family Engagem ent Urinary Incontinence: Plan of Care for Urinary Incontinence in Women Aged 65 Years and Older: Percentage of female patients aged 65 years and older with a diagnosis of urinary incontinence with a documented plan of care for urinary incontinence at least once within 12 months AMA

- PCPI/ NCQ A X X

0091/ 51 Clinical Process/ Effective ness Chronic Obstructive Pulmonary Disease (COPD): Spirometry Evaluation: Percentage of patients aged 18 years and older with a diagnosis of COPD who had spirometry evaluation results documented AMA -PCPI X X X

0102/ 52 Clinical Process/ Effective ness Chronic Obstructive Pulmonary Disease (COPD): Bronchodilator Therapy: Percentage of patients aged 18 years and older with a diagnosis of COPD and who have an FEV 1 /FVC less than 60% and have symptoms who were prescribed an inhaled bronchodilator AMA -PCPI X X X

0047/ Clinical Asthma: Pharmacologic Therapy for AMA X X X X MU1991

53 Process/ Effective ness Persistent Asthma - Ambulatory Care Setting: Percentage of patients aged 5 through 50 years with a diagnosis of persistent asthma and at least one medical encounter for asthma during the measurement year who were prescribed long-term control medication - PCPI/ NCQ A

0090/ 54 Clinical Process/ Effective ness Emergency Medicine: 12-Lead Electrocardiogram (ECG) Performed for Non- Traumatic Chest Pain: Percentage of patients aged 40 years and older with an emergency department discharge diagnosis of non-traumatic chest pain who had a 12-lead ECG performed AMA

- PCPI/ NCQ A X X

0093/ 55 Clinical Process/ Effective ness Emergency Medicine: 12-Lead Electrocardiogram (ECG) Performed for Syncope: Percentage of patients aged 60 years and older with an emergency department discharge diagnosis of syncope who had a 12-lead ECG performed AMA

- PCPI/ NCQ A X X

0232/ 56 Clinical Process/ Effective ness Emergency Medicine: CommunityAcquired Pneumonia (CAP): Vital Signs: Percentage of patients aged 18 years and older with a diagnosis of community-acquired bacterial pneumonia with vital signs documented and reviewed AMA

- PCPI/ NCQ A X X

0096/ 59 Clinical Process/ Effective ness Emergency Medicine: CommunityAcquired Pneumonia (CAP): Empiric Antibiotic: Percentage of patients aged 18 years and older with a diagnosis of community-acquired bacterial pneumonia with an appropriate empiric antibiotic prescribed AMA

- PCPI/ NCQ A X X

0001/ 64 Clinical Process/ Effective ness Asthma: Assessment of Asthma Control – Ambulatory Care Setting: Percentage of patients aged 5 through 50 years with a diagnosis of asthma who were evaluated at least once for asthma control (comprising asthma impairment and asthma risk) AMA

- PCPI/ NCQ A X X X X MU1

0069/ 65 Efficient Use of Healthcar e Resource s Appropriate Treatment for Children with Upper Respiratory Infection (URI): Percentage of children aged 3 months through 18 years with a diagnosis of URI who were not prescribed or dispensed an antibiotic prescription on or within 3 days of the initial date of service NCQ A X X MU2

0002/ Efficient Appropriate Testing for Children NCQ X X X MU1/992

66 Use of Healthcar e Resource s with Pharyngitis: Percentage of children aged 2 through 18 years with a diagnosis of pharyngitis, who were prescribed an antibiotic and who received a group A streptococcus (strep) test for the episode. A higher rate represents better performance (i.e. appropriate testing). A MU2

0377/ 67 Clinical Process/ Effective ness Hematology: Myelodysplastic Syndrome (MDS) and Acute Leukemias: Baseline Cytogenetic Testing Performed on Bone Marrow: Percentage of patients aged 18 years and older with a diagnosis of MDS or an acute leukemia who had baseline cytogenetic testing performed on bone marrow AMA

- PCPI/ ASH X X

0378/ 68 Clinical Process/ Effective ness Hematology: Myelodysplastic Syndrome (MDS): Documentation of Iron Stores in Patients Receiving Erythropoietin Therapy: Percentage of patients aged 18 years and older with a diagnosis of MDS who are receiving erythropoietin therapy with documentation of iron stores within 60 days prior to initiating erythropoietin therapy AMA

- PCPI/ ASH X X

0380/ 69 Clinical Process/ Effective ness Hematology: Multiple Myeloma: Treatment with Bisphosphonates: Percentage of patients aged 18 years and older with a diagnosis of multiple myeloma, not in remission, who were prescribed or received intravenous bisphosphonate therapy within the 12- month reporting period AMA

- PCPI/ ASH X X

0379/ 70 Clinical Process/ Effective ness Hematology: Chronic Lymphocytic Leukemia (CLL): Baseline Flow Cytometry: Percentage of patients aged 18 years and older seen within a 12 month reporting period with a diagnosis of chronic lymphocytic leukemia (CLL) made at any time during or prior to the reporting period who had baseline flow cytometry studies performed and documented in the chart AMA

- PCPI/ ASH X X

0387/ 71 Clinical Process/ Effective ness Breast Cancer: Hormonal Therapy for Stage IC - IIIC Estrogen Receptor/Progesterone Receptor (ER/PR) Positive Breast Cancer: Percentage of female patients aged 18 years and older with Stage IC through IIIC, ER or PR positive breast cancer AMA

- PCPI/ ASC O/NC CN X X X X MU1/ MU2993
who were prescribed tamoxifen or aromatase inhibitor (AI) during the 12- month reporting period 0385/ 72 Clinical Process/ Effective ness Colon Cancer: Chemotherapy for AJCC Stage III Colon Cancer Patients: Percentage of patients aged 18 through 80 years with AJCC Stage III colon cancer who are referred for adjuvant chemotherapy, prescribed adjuvant chemotherapy, or have previously received adjuvant chemotherapy within the 12-month reporting period AMA

- PCPI/ ASC O/NC CN X X X X MU1/ MU2

0464/ 76 Patient Safety Prevention of Catheter-Related Bloodstream Infections (CRBSI): Central Venous Catheter (CVC) Insertion Protocol: Percentage of patients, regardless of age, who undergo CVC insertion for whom CVC was inserted with all elements of maximal sterile barrier technique [cap AND mask AND sterile gown AND sterile gloves AND a large sterile sheet AND hand hygiene AND 2% chlorhexidine for cutaneous antisepsis (or acceptable alternative antiseptics per current guideline)] followed AMA -PCPI X X

0323/ 81 Care Coordinat ion Adult Kidney Disease: Hemodialysis Adequacy: Solute: Percentage of calendar months within a 12-month period during which patients aged 18 years and older with a diagnosis of ESRD receiving hemodialysis three times a week for ≥ 90 days who have a spKt/V ≥ 1.2 AMA -PCPI X

0321/ 82 Care Coordinat ion Adult Kidney Disease: Peritoneal Dialysis Adequacy: Solute: Percentage of patients aged 18 years and older with a diagnosis of ESRD receiving peritoneal dialysis who have a total Kt/V ≥ 1.7 per week measured once every 4 months AMA -PCPI X

0393/ 83 Clinical Process/ Effective ness Hepatitis C: Testing for Chronic Hepatitis C – Confirmation of Hepatitis C Viremia: Percentage of patients aged 18 years and older with a diagnosis of hepatitis C seen for an initial evaluation who had HCV RNA testing ordered or previously performed AMA -PCPI X

0395/ 84 Clinical Process/ Effective Hepatitis C: Ribonucleic Acid (RNA) Testing Before Initiating Treatment: Percentage of patients aged 18 years and AMA -PCPI X X X994
ness older with a diagnosis of chronic hepatitis C who are receiving antiviral treatment for whom quantitative HCV RNA testing was performed within 6 months prior to initiation of antiviral treatment 0396/ 85 Clinical Process/ Effective ness Hepatitis C: HCV Genotype Testing Prior to Treatment: Percentage of patients aged 18 years and older with a diagnosis of chronic hepatitis C who are receiving antiviral treatment for whom HCV genotype testing was performed prior to initiation of antiviral treatment AMA -PCPI X X X

0397/ 86 Clinical Process/ Effective ness Hepatitis C: Antiviral Treatment Prescribed: Percentage of patients aged 18 years and older with a diagnosis of chronic hepatitis C who were prescribed at a minimum peginterferon and ribavirin therapy within the 12-month reporting period AMA -PCPI X X X

0398/ 87 Clinical Process/ Effective ness Hepatitis C: HCV Ribonucleic Acid (RNA) Testing at Week 12 of Treatment: Percentage of patients aged 18 years and older with a diagnosis of chronic hepatitis C who are receiving antiviral treatment for whom quantitative HCV RNA testing was performed at no greater than 12 weeks from the initiation of antiviral treatment AMA -PCPI X X X

0401/ 89 Clinical Process/ Effective ness Hepatitis C: Counseling Regarding Risk of Alcohol Consumption: Percentage of patients aged 18 years and older with a diagnosis of hepatitis C who were counseled about the risks of alcohol use at least once within 12- months AMA -PCPI X X X

0394/ 90 Clinical Process/ Effective ness Hepatitis C: Counseling Regarding Use of Contraception Prior to Antiviral Therapy: Percentage of female patients aged 18 through 44 years and all men aged 18 years and older with a diagnosis of chronic hepatitis C who are receiving antiviral treatment who were counseled regarding contraception prior to the initiation of treatment AMA -PCPI X X X

0653/ 91 Clinical Process/ Effective ness Acute Otitis Externa (AOE): Topical Therapy: Percentage of patients aged 2 years and older with a diagnosis of AOE who were prescribed topical preparations AMA -PCPI X X

0654/ 93 Care Coordinat Acute Otitis Externa (AOE): Systemic Antimicrobial Therapy – Avoidance AMA -PCPI X X995

ion of Inappropriate Use: Percentage of patients aged 2 years and older with a diagnosis of AOE who were not prescribed systemic antimicrobial therapy 0391/ 99 Clinical Process/ Effective ness Breast Cancer Resection Pathology Reporting: pT Category (Primary Tumor) and pN Category (Regional Lymph Nodes) with Histologic Grade: Percentage of breast cancer resection pathology reports that include the pT category (primary tumor), the pN category (regional lymph nodes), and the histologic grade AMA

- PCPI/ CAP X X

0392/ 100 Clinical Process/ Effective ness Colorectal Cancer Resection Pathology Reporting: pT Category (Primary Tumor) and pN Category (Regional Lymph Nodes) with Histologic Grade: Percentage of colon and rectum cancer resection pathology reports that include the pT category (primary tumor), the pN category (regional lymph nodes) and the histologic grade AMA

- PCPI/ CAP X X

0389/ 102 Efficient Use of Healthcar e Resource s Prostate Cancer: Avoidance of Overuse of Bone Scan for Staging Low-Risk Prostate Cancer Patients: Percentage of patients, regardless of age, with a diagnosis of prostate cancer at low risk of recurrence receiving interstitial prostate brachytherapy, OR external beam radiotherapy to the prostate, OR radical prostatectomy, OR cryotherapy who did not have a bone scan performed at any time since diagnosis of prostate cancer AMA -PCPI X X X MU1/ MU2

0390/ 104 Clinical Process/ Effective ness Prostate Cancer: Adjuvant Hormonal Therapy for High Risk Prostate Cancer Patients: Percentage of patients, regardless of age, with a diagnosis of prostate cancer at high risk of recurrence receiving external beam radiotherapy to the prostate who were prescribed adjuvant hormonal therapy (GnRH agonist or antagonist) AMA -PCPI X X

0103/ 106 Clinical Process/ Effective ness Adult Major Depressive Disorder (MDD): Comprehensive Depression Evaluation: Diagnosis and Severity: Percentage of patients aged 18 years and older with a diagnosis of major depressive disorder (MDD) with AMA -PCPI X X996
evidence that they met the DSM-IV-TR criteria for MDD AND for whom there is an assessment of depression severity during the visit in which a new diagnosis or recurrent episode was identified 0104/ 107 Clinical Process/ Effective ness Adult Major Depressive Disorder (MDD): Suicide Risk Assessment: Percentage of patients aged 18 years and older with a diagnosis of major depressive disorder (MDD) with a suicide risk assessment completed during the visit in which a new diagnosis or recurrent episode was identified AMA -PCPI X X MU2

0054/ 108 Clinical Process/ Effective ness Rheumatoid Arthritis (RA): Disease Modifying Anti-Rheumatic Drug (DMARD) Therapy: Percentage of patients aged 18 years and older who were diagnosed with RA and were prescribed, dispensed, or administered at least one ambulatory prescription for a DMARD NCQ A X X X

0050/ 109 Patient and Family Engagem ent Osteoarthritis (OA): Function and Pain Assessment: Percentage of patient visits for patients aged 21 years and older with a diagnosis of OA with assessment for function and pain AMA -PCPI X X

0041/ 110 Populatio n/Public Health Preventive Care and Screening: Influenza Immunization: Percentage of patients aged 6 months and older seen for a visit between October 1 and March 31 who received an influenza immunization OR who reported previous receipt of an influenza immunization AMA -PCPI X X X X X MU1/ MU2 ACO

0043/ 111 Clinical Process/ Effective ness Preventive Care and Screening: Pneumococcal Vaccination for Patients 65 Years and Older: Percentage of patients aged 65 years and older who have ever received a pneumococcal vaccine NCQ A X X X X X MU1/ MU2 ACO

0031/ 112 Clinical Process/ Effective ness Preventive Care and Screening: Breast Cancer Screening: Percentage of women aged 40 through 69 years who had a mammogram to screen for breast cancer within 24 months NCQ A X X X X X MU1/ MU2 ACO

0034/ 113 Clinical Process/ Effective ness Preventive Care and Screening: Colorectal Cancer Screening: Percentage of patients aged 50 through 75 years who received the appropriate colorectal cancer screening NCQ A X X X X X MU1/ MU2 ACO

0058/ 116 Efficient Use of Antibiotic Treatment for Adults with Acute Bronchitis: Avoidance of NCQ A X X997

Healthcar e Resource s Inappropriate Use: Percentage of adults aged 18 through 64 years with a diagnosis of acute bronchitis who were not prescribed or dispensed an antibiotic prescription on or within 3 days of the initial date of service 0055/ 117 Clinical Process/ Effective ness Diabetes Mellitus: Dilated Eye Exam: Percentage of patients aged 18 through 75 years with a diagnosis of diabetes mellitus who had a dilated eye exam NCQ A X X X X MU1/ MU2

0066/ 118 Clinical Process/ Effective ness Coronary Artery Disease (CAD): Angiotensin-Converting Enzyme (ACE) Inhibitor or Angiotensin Receptor Blocker (ARB) Therapy - Diabetes or Left Ventricular Systolic Dysfunction (LVEF < 40%): Percentage of patients aged 18 years and older with a diagnosis of coronary artery disease seen within a 12 month period who also have diabetes OR a current or prior Left Ventricular Ejection Fraction (LVEF) < 40% who were prescribed ACE inhibitor or ARB therapy AMA

- PCPI/ ACC F/AH A X X ACO

0062/ 119 Clinical Process/ Effective ness Diabetes: Medical Attention for Nephropathy: Percentage of patients aged 18 through 75 years with diabetes mellitus who received urine protein screening or medical attention for nephropathy during at least one office visit within 12 months NCQ A X X X X MU1/ MU2

AQA adopt ed/ 121 Clinical Process/ Effective ness Adult Kidney: Disease Laboratory Testing (Lipid Profile): Percentage of patients aged 18 years and older with a diagnosis of CKD (stage 3, 4, or 5, not receiving Renal Replacement Therapy [RRT]) who had a fasting lipid profile performed at least once within a 12- month period AMA -PCPI X X X

AQA adopt ed/ 122 Clinical Process/ Effective ness Adult Kidney Disease: Blood Pressure Management: Percentage of patient visits for those patients aged 18 years and older with a diagnosis of CKD (stage 3, 4, or 5, not receiving Renal Replacement Therapy [RRT]) and documented proteinuria with a blood pressure < 130/80 mmHg OR ≥ 130/80 mmHg with a documented plan of care AMA -PCPI X X X

AQA adopt ed/ 123 Clinical Process/ Effective ness Adult Kidney Disease: Patients On Erythropoiesis-Stimulating Agent (ESA) - Hemoglobin Level > 12.0 g/dL: Percentage of calendar months within a 12-month period during which a AMA -PCPI X X X998
Hemoglobin level is measured for patients aged 18 years and older with a diagnosis of advanced Chronic Kidney Disease (CKD) (stage 4 or 5, not receiving RRT [Renal Replacement Therapy]) or End Stage Renal Disease (ESRD) (who are on hemodialysis or peritoneal dialysis) who are also receiving ESA therapy AND have a Hemoglobin level > 12.0 g/dL 0417/ 126 Clinical Process/ Effective ness Diabetes Mellitus: Diabetic Foot and Ankle Care, Peripheral Neuropathy – Neurological Evaluation: Percentage of patients aged 18 years and older with a diagnosis of diabetes mellitus who had a neurological examination of their lower extremities within 12 months APM A X X

0416/ 127 Clinical Process/ Effective ness Diabetes Mellitus: Diabetic Foot and Ankle Care, Ulcer Prevention – Evaluation of Footwear: Percentage of patients aged 18 years and older with a diagnosis of diabetes mellitus who were evaluated for proper footwear and sizing APM A X X

0421/ 128 Populatio n/Public Health Preventive Care and Screening: Body Mass Index (BMI) Screening and Follow-Up: Percentage of patients aged 18 years and older with a calculated BMI in the past 6 months or during the current visit documented in the medical record AND if the most recent BMI is outside of normal parameters , a follow-up plan is documented within the past 6 months or during the current visit Normal Parameters: Age 65 years and older BMI ≥ 23 and < 30; Age 18 – 64 years BMI ≥ 18.5 and < 25 CMS/ QIP X X X X X MU1/ MU2 ACO

0419/ 130 Patient Safety Documentation of Current Medications in the Medical Record: Percentage of specified visits for patients aged 18 years and older for which the eligible professional attests to documenting a list of current medications to the best of his/her knowledge and ability. This list mustinclude ALL prescriptions, over-thecounters, herbals, and vitamin/mineral/dietary (nutritional) supplements AND must contain the medications’ name, dosage, frequency and route of administration CMS/ QIP X X X MU2

0420/ 131 Populatio n/Public Pain Assessment and Follow-Up: Percentage of visits for patients aged 18 CMS/ QIP X X999
Health years and older with documentation of a pain assessment through discussion with the patient including the use of a standardized tool(s) on each visit AND documentation of a follow-up plan when pain is present 0418/ 134 Populatio n/Public Health Preventive Care and Screening: Screening for Clinical Depression and Follow-Up Plan: Percentage of patients aged 12 years and older screened for clinical depression on the date of encounter using an age appropriate standardized depression screening tool AND, if positive, a follow-up plan is documented on the date of the positive screen CMS/ QIP X X X MU2 ACO

0650/ 137 Clinical Process/ Effective ness Melanoma: Continuity of Care – Recall System: Percentage of patients, regardless of age, with a current diagnosis of melanoma or a history of melanoma whose information was entered, at least once within a 12 month period, into a recall system that includes: • A target date for the next complete physical skin exam, AND • A process to follow up with patients who either did not make an appointment within the specified timeframe or who missed a scheduled appointment AMA

- PCPI/ NCQ A X

0561/ 138 Care Coordinat ion Melanoma: Coordination of Care: Percentage of patient visits, regardless of age, with a new occurrence of melanoma who have a treatment plan documented in the chart that was communicated to the physician(s) providing continuing care within one month of diagnosis AMA

- PCPI/ NCQ A X

0566/ 140 Clinical Process/ Effective ness Age-Related Macular Degeneration (AMD): Counseling on Antioxidant Supplement: Percentage of patients aged 50 years and older with a diagnosis of age-related macular degeneration or their caregiver(s) who were counseled within 12 months on the benefits and/or risks of the Age-Related Eye Disease Study (AREDS) formulation for preventing progression of AMD AMA

- PCPI/ NCQ A X X

0563/ 141 Care Coordinat ion Primary Open-Angle Glaucoma (POAG): Reduction of Intraocular Pressure (IOP) by 15% OR Documentation of a Plan of Care: Percentage of patients aged 18 years andolder with a diagnosis of primary openAMA

- PCPI/ NCQ A X X1000
angle glaucoma whose glaucoma treatment has not failed (the most recent IOP was reduced by at least 15% from the pre- intervention level) OR if the most recent IOP was not reduced by at least 15% from the pre- intervention level, a plan of care was documented within 12 months 0051/ 142 Clinical Process/ Effective ness Osteoarthritis (OA): Assessment for Use of Anti-Inflammatory or Analgesic Over-the-Counter (OTC) Medications: Percentage of patient visits for patients aged 21 years and older with a diagnosis of OA with an assessment for use of anti-inflammatory or analgesic OTC medications AMA -PCPI X X

0384/ 143 Patient and Family Engagem ent Oncology: Medical and Radiation – Pain Intensity Quantified: Percentage of patient visits, regardless of patient age, with a diagnosis of cancer currently receiving chemotherapy or radiation therapy in which pain intensity is quantified AMA -PCPI X X MU2

0383/ 144 Patient and Family Engagem ent Oncology: Medical and Radiation – Plan of Care for Pain: Percentage of visits for patients, regardless of age, with a diagnosis of cancer currently receiving chemotherapy or radiation therapy who report having pain with a documented plan of care to address pain AMA -PCPI X X

0510/ 145 Patient Safety Radiology: Exposure Time Reported for Procedures Using Fluoroscopy: Percentage of final reports for procedures using fluoroscopy that include documentation of radiation exposure or exposure time AMA

- PCPI/ NCQ A X X

0508/ 146 Efficient Use of Healthcar e Resource s Radiology: Inappropriate Use of “Probably Benign” Assessment Category in Mammography Screening: Percentage of final reports for screening mammograms that are classified as “probably benign” AMA

- PCPI/ NCQ A X X

0511/ 147 Care Coordinat ion Nuclear Medicine: Correlation with Existing Imaging Studies for All Patients Undergoing Bone Scintigraphy: Percentage of final reports for all patients, regardless of age, undergoing bone scintigraphy that include physician documentation of correlation with existing relevant imaging studies (e.g., x-ray, MRI, CT, etc.) that were performed AMA -PCPI X X1001

0322/ 148 Efficient Use of Healthcar e Resource s Back Pain: Initial Visit: The percentage of patients aged 18 through 79 years with a diagnosis of back pain or undergoing back surgery who had back pain and function assessed during the initial visit to the clinician for the episode of back pain NCQ A X

0319/ 149 Clinical Process/ Effective ness Back Pain: Physical Exam: Percentage of patients aged 18 through 79 years with a diagnosis of back pain or undergoing back surgery who received a physical examination at the initial visit to the clinician for the episode of back pain NCQ A X

0314/ 150 Clinical Process/ Effective ness Back Pain: Advice for Normal Activities: The percentage of patients aged 18 through 79 years with a diagnosis of back pain or undergoing back surgery who received advice for normal activities at the initial visit to the clinician for the episode of back pain NCQ A X

0313/ 151 Clinical Process/ Effective ness Back Pain: Advice Against Bed Rest: The percentage of patients aged 18 through 79 years with a diagnosis of back pain or undergoing back surgery who received advice against bed rest lasting 4 days or longer at the initial visit to the clinician for the episode of back pain NCQ A X

0101/ 154 Patient Safety Falls: Risk Assessment: Percentage of patients aged 65 years and older with a history of falls who had a risk assessment for falls completed within 12 months AMA

- PCPI/ NCQ A X X

0101/ 155 Care Coordinat ion Falls: Plan of Care: Percentage of patients aged 65 years and older with a history of falls who had a plan of care for falls documented within 12 months AMA

- PCPI/ NCQ A X X

0382/ 156 Patient Safety Oncology: Radiation Dose Limits to Normal Tissues: Percentage of patients, regardless of age, with a diagnosis of pancreatic or lung cancer receiving 3D conformal radiation therapy with documentation in medical record that radiation dose limits to normal tissues were established prior to the initiation of a course of 3D conformal radiation for a minimum of two tissues AMA -PCPI X X

0455/ 157 Patient Safety Thoracic Surgery: Recording of Clinical Stage Prior to Lung Cancer or Esophageal Cancer Resection: STS X X1002
Percentage of surgical patients aged 18 years and older undergoing resection for lung or esophageal cancer who had clinical staging provided prior to surgery 0404/ 159 Clinical Process/ Effective ness HIV/AIDS: CD4+ Cell Count or CD4+ Percentage: Percentage of patients aged 6 months and older with a diagnosis of HIV/AIDS for whom a CD4+ cell count or CD4+ cell percentage was performed at least once every 6 months AMA

- PCPI/ NCQ A X X

0405/ 160 Clinical Process/ Effective ness HIV/AIDS: Pneumocystis Jiroveci Pneumonia (PCP) Prophylaxis: Percentage of patients aged 6 years and older with a diagnosis of HIV/AIDS and CD4+ cell count < 200 cells/mm 3 who were prescribed PCP prophylaxis within 3 months of low CD4+ cell count AMA

- PCPI/ NCQ A X X MU2

0406/ 161 Clinical Process/ Effective ness HIV/AIDS: Adolescent and Adult Patients with HIV/AIDS Who Are Prescribed Potent Antiretroviral Therapy: Percentage of patients with a diagnosis of HIV/AIDS aged 13 years and older: who have a history of a nadir CD4+ cell count below 350/mm 3 or who have a history of an AIDS-defining condition, regardless of CD4+ cell count; or who are pregnant, regardless of CD4+ cell count or age, who were prescribed potent antiretroviral therapy AMA

- PCPI/ NCQ A X X

N/A/ 162 Clinical Process/ Effective ness HIV/AIDS: HIV RNA Control After Six Months of Potent Antiretroviral Therapy: Percentage of patients aged 13 years and older with a diagnosis of HIV/AIDS who are receiving potent antiretroviral therapy, who have a viral load below limits of quantification after at least 6 months of potent antiretroviral therapy or patients whose viral load is not below limits of quantification after at least 6 months of potent antiretroviral therapy and have documentation of a plan of care AMA

- PCPI/ NCQ A X X MU2

0056/ 163 Clinical Process/ Effective ness Diabetes Mellitus: Foot Exam: The percentage of patients aged 18 through 75 years with diabetes who had a foot examination NCQ A X X X X MU1/ MU2

0129/ 164 Clinical Process/ Effective ness Coronary Artery Bypass Graft (CABG): Prolonged Intubation: Percentage of patients aged 18 years and older undergoing isolated CABG surgery who require intubation > 24 STS X X1003

hours 0130/ 165 Clinical Process/ Effective ness Coronary Artery Bypass Graft (CABG): Deep Sternal Wound Infection Rate: Percentage of patients aged 18 years and older undergoing isolated CABG surgery who, within 30 days postoperatively, develop deep sternal wound infection involving muscle, bone, and/or mediastinum requiring operative intervention STS X X

0131/ 166 Clinical Process/ Effective ness Coronary Artery Bypass Graft (CABG): Stroke: Percentage of patients aged 18 years and older undergoing isolated CABG surgery who have a postoperative stroke (i.e., any confirmed neurological deficit of abrupt onset caused by a disturbance in blood supply to the brain) that did not resolve within 24 hours STS X X

0114/ 167 Clinical Process/ Effective ness Coronary Artery Bypass Graft (CABG): Postoperative Renal Failure: Percentage of patients aged 18 years and older undergoing isolated CABG surgery (without pre-existing renal failure) who develop postoperative renal failure or require dialysis STS X X

0115/ 168 Clinical Process/ Effective ness Coronary Artery Bypass Graft (CABG): Surgical Re-Exploration: Percentage of patients aged 18 years and older undergoing isolated CABG surgery who require a return to the operating room (OR) during the current hospitalization for mediastinal bleeding with or without tamponade, graft occlusion, valve dysfunction, or other cardiac reason STS X X

0116/ 169 Clinical Process/ Effective ness Coronary Artery Bypass Graft (CABG): Antiplatelet Medications at Discharge: Percentage of patients aged 18 years and older undergoing isolated CABG surgery who were discharged on antiplatelet medication STS X X

0117/ 170 Clinical Process/ Effective ness Coronary Artery Bypass Graft (CABG): Beta-Blockers Administered at Discharge: Percentage of patients aged 18 years and older undergoing isolated CABG surgery who were discharged on beta-blockers STS X X

0118/ 171 Clinical Process/ Effective Coronary Artery Bypass Graft (CABG): Anti-Lipid Treatment at Discharge: Percentage of patients aged STS X X1004
ness 18 years and older undergoing isolated CABG surgery who were discharged on a statin or other lipid-lowering regimen 0259/ 172 Clinical Process/ Effective ness Hemodialysis Vascular Access Decision-Making by Surgeon to Maximize Placement of Autogenous Arterial Venous (AV) Fistula: Percentage of patients aged 18 years and older with a diagnosis of advanced Chronic Kidney Disease (CKD) (stage 4 or 5) or End Stage Renal Disease (ESRD) requiring hemodialysis vascular access documented by surgeon to have received autogenous AV fistula SVS X X

AQA adopt ed/ 173 

### ◊ Populatio n/Public Health Preventive Care and Screening: Unhealthy Alcohol Use – Screening: Percentage of patients aged 18 years and older who were screened for unhealthy alcohol use using a systematic screening method within 24 months AMA -PCPI X X X X

AQA adopt ed/ 176 Clinical Process/ Effective ness Rheumatoid Arthritis (RA): Tuberculosis Screening: Percentage of patients aged 18 years and older with a diagnosis of RA who have documentation of a tuberculosis (TB) screening performed and results interpreted within 6 months prior to receiving a first course of therapy usinga biologic disease-modifying antirheumatic drug (DMARD) AMA

- PCPI/ NCQ A X X X

AQA adopt ed/ 177 Clinical Process/ Effective ness Rheumatoid Arthritis (RA): Periodic Assessment of Disease Activity: Percentage of patients aged 18 years and older with a diagnosis of RA who have an assessment and classification of disease activity within 12 months AMA

- PCPI/ NCQ A X X X

AQA adopt ed/ 178 Clinical Process/ Effective ness Rheumatoid Arthritis (RA): Functional Status Assessment: Percentage of patients aged 18 years and older with a diagnosis of RA for whom a functional status assessment was performed at least once within 12 months AMA

- PCPI/ NCQ A X X X

AQA adopt ed/ 179 Clinical Process/ Effective ness Rheumatoid Arthritis (RA): Assessment and Classification of Disease Prognosis: Percentage of patients aged 18 years and older with a diagnosis of RA who have an assessment and classification of disease prognosis at least once within 12 months AMA

- PCPI/ NCQ A X X X

AQA adopt Care Coordinat Rheumatoid Arthritis (RA): Glucocorticoid Management: AMA

- X X X1005

ed/ 180 ion Percentage of patients aged 18 years and older with a diagnosis of RA who have been assessed for glucocorticoid use and, for those on prolonged doses of prednisone ≥ 10 mg daily (or equivalent) with improvement or no change in disease activity, documentation of glucocorticoid management plan within 12 months PCPI/ NCQ A

AQA adopt ed/ 181 Patient Safety Elder Maltreatment Screen and Follow-Up Plan: Percentage of patients aged 65 years and older with a documented elder maltreatment screen on the date of encounter AND a documented follow-up plan on the date of the positive screen CMS/ QIP X X

AQA adopt ed/ 182 Care Coordinat ion Functional Outcome Assessment: Percentage of visits for patients aged 18 years and older with documentation of a current functional outcome assessment using a standardized functional outcome assessment tool on the date of encounter AND documentation of a care plan based on identified functional outcome deficiencies on the date of the identified deficiencies CMS/ QIP X X

0399/ 183 Populatio n/Public Health Hepatitis C: Hepatitis A Vaccination in Patients with HCV: Percentage of patients aged 18 years and older with a diagnosis of hepatitis C who received at least one injection of hepatitis A vaccine, or who have documented immunity to hepatitis A AMA -PCPI X X X

0400/ 184 Populatio n/Public Health Hepatitis C: Hepatitis B Vaccination in Patients with HCV: Percentage of patients aged 18 years and older with a diagnosis of hepatitis C who received at least one injection of hepatitis B vaccine, or who have documented immunity to hepatitis B AMA -PCPI X X X

0659/ 185 Care Coordinat ion Endoscopy & Polyp Surveillance: Colonoscopy Interval for Patients with a History of Adenomatous Polyps – Avoidance of Inappropriate Use: Percentage of patients aged 18 years and older receiving a surveillance colonoscopy, with a history of a prior colonic polyp(s) in previous colonoscopy findings, who had an interval of 3 or more years since their last colonoscopy AMA

- PCPI/ NCQ A X X

0437/ Clinical Stroke and Stroke Rehabilitation: AHA/ X1006

187 Process/ Effective ness Thrombolytic Therapy: Percentage of patients aged 18 years and older with a diagnosis of acute ischemic stroke who arrive at the hospital within 2 hours oftime last known well and for whom IV tPA was initiated within 3 hours of time last known well ASA/ TJC

N/A/ 188 Care Coordinat ion Referral for Otologic Evaluation for Patients with Congenital or Traumatic Deformity of the Ear: Percentage of patients aged birth and older referred to a physician (preferably a physician with training in disorders of the ear) for an otologic evaluation subsequent to an audiologic evaluation after presenting with a congenital or traumatic deformity of the ear (internal or external) AQC X X

N/A/ 189 Care Coordinat ion Referral for Otologic Evaluation for Patients with History of Active Drainage from the Ear Within the Previous 90 Days: Percentage of patients aged birth and older who have disease of the ear and mastoid processes referred to a physician (preferably a physician with training in disorders of the ear) for an otologic evaluation subsequent to an audiologic evaluation after presenting with a history of active drainage from the ear within the previous 90 days AQC X X

N/A/ 190 Care Coordinat ion Referral for Otologic Evaluation for Patients with a History of Sudden or Rapidly Progressive Hearing Loss: Percentage of patients aged birth and older referred to a physician (preferably a physician with training in disorders of the ear) for an otologic evaluation immediately following an audiologic evaluation that verifies and documents sudden or rapidly progressive hearing loss AQC X X

0565/ 191 Clinical Process/ Effective ness Cataracts: 20/40 or Better Visual Acuity within 90 Days Following Cataract Surgery: Percentage of patients aged 18 years and older with a diagnosis of uncomplicated cataract who had cataract surgery and no significant ocular conditions impacting the visualoutcome of surgery and had bestcorrected visual acuity of 20/40 or better (distance or near) achieved within 90 AMA

- PCPI/ NCQ A X X MU21007
days following the cataract surgery 0564/ 192 Patient Safety Cataracts: Complications within 30 Days Following Cataract Surgery Requiring Additional Surgical Procedures: Percentage of patients aged 18 years and older with a diagnosis of uncomplicated cataract who had cataract surgery and had any of a specified list of surgical procedures in the 30 days following cataract surgery which would indicate the occurrence of any of the following major complications: retained nuclear fragments, endophthalmitis, dislocated or wrong power IOL, retinal detachment, or wound dehiscence AMA

- PCPI/ NCQ A X X MU2

0454/ 193 Patient Safety Perioperative Temperature Management: Percentage of patients, regardless of age, undergoing surgical or therapeutic procedures under general or neuraxial anesthesia of 60 minutes duration or longer, except patients undergoing cardiopulmonary bypass, for whom either active warming was used intraoperatively for the purpose of maintaining normothermia, OR at least one body temperature equal to or greater than 36 degrees Centigrade (or 96.8 degrees Fahrenheit) was recorded within the 30 minutes immediately before or the 15 minutes immediately after anesthesia end time AMA -PCPI X X

0386/ 194 Clinical Process/ Effective ness Oncology: Cancer Stage Documented: Percentage of patients, regardless of age, with a diagnosis of cancer who are seen in the ambulatory setting who have a baseline AJCC cancer stage or documentation that the cancer is metastatic in the medical record at least once within 12 months AMA

- PCPI/ ASC O X X X

0507/ 195 Clinical Process/ Effective ness Radiology: Stenosis Measurement in Carotid Imaging Reports: Percentage of final reports for carotid imaging studies (neck magnetic resonance angiography [MRA], neck computed tomography angiography [CTA], neck duplex ultrasound, carotid angiogram) performed that include direct or indirect reference to measurements of distal internal carotid diameter as the denominator for stenosis measurement AMA

- PCPI/ NCQ A X X

0074/ 197 Clinical Process/ Coronary Artery Disease (CAD): Lipid Control: Percentage of patients AMA

- X X X X MU1 ACO1008

Effective ness aged 18 years and older with a diagnosis of coronary artery disease seen within a 12 month period who have a LDL-C result < 100 mg/dL OR patients who have a LDL-C result ≥ 100 mg/dL and have a documented plan of care to achieve LDL-C < 100 mg/dL, including at a minimum the prescription of a statin PCPI/ ACC F/AH A

0079/ 198 Clinical Process/ Effective ness Heart Failure: Left Ventricular Ejection Fraction (LVEF) Assessment: Percentage of patients aged 18 years and older with a diagnosis of heart failure for whom the quantitative or qualitative results of a recent or prior [any time in the past] LVEF assessment is documented within a 12 month period AMA

- PCPI/ ACC F/AH A X X

0084/ 200 

### ◊ Clinical Process/ Effective ness Heart Failure: Warfarin Therapy for Patients with Atrial Fibrillation: Percentage of all patients aged 18 and older with a diagnosis of heart failure and paroxysmal or chronic atrial fibrillation who were prescribed warfarin therapy AMA

- PCPI/ ACC F/A HA X MU1

0073/ 201 Clinical Process/ Effective ness Ischemic Vascular Disease (IVD): Blood Pressure Management: Percentage of patients aged 18 to 75 years with Ischemic Vascular Disease (IVD) who had most recent blood pressure in control (less than 140/90 mmHg) NCQ A X X X X MU1

0068/ 204 Clinical Process/ Effective ness Ischemic Vascular Disease (IVD): Use of Aspirin or Another Antithrombotic: Percentage of patients aged 18 years and older with Ischemic Vascular Disease (IVD) with documented use of aspirin or another antithrombotic NCQ A X X X X X MU1/ MU2 ACO Million Hearts

0409/ 205 Clinical Process/ Effective ness HIV/AIDS: Sexually Transmitted Disease Screening for Chlamydia and Gonorrhea: Percentage of patients aged 13 years and older with a diagnosis of HIV/AIDS for whom chlamydia and gonorrhea screenings were performed at least once since the diagnosis of HIV infection AMA

- PCPI/ NCQ A X X

0410/ 208 Clinical Process/ Effective ness HIV/AIDS: Sexually Transmitted Disease Screening for Syphilis: Percentage of patients aged 13 years and older with a diagnosis of HIV/AIDS who were screened for syphilis at least once within 12 months AMA

- PCPI/ NCQ A X X

0445/ Clinical Functional Communication Measure - ASH X1009

209 Process/ Effective ness Spoken Language Comprehension: Percentage of patients aged 16 years and older with a diagnosis of late effects of cerebrovascular disease (CVD) that make progress on the Spoken Language Comprehension Functional Communication Measure A

0449/ 210 Clinical Process/ Effective ness Functional Communication Measure – Attention: Percentage of patients aged 16 years and older with a diagnosis of late effects of cerebrovascular disease (CVD) that make progress on the Attention Functional Communication Measure ASH A X

0448/ 211 Clinical Process/ Effective ness Functional Communication Measure – Memory: Percentage of patients aged 16 years and older with a diagnosis of late effects of cerebrovascular disease (CVD) that make progress on the Memory Functional Communication Measure ASH A X

0447/ 212 Clinical Process/ Effective ness Functional Communication Measure - Motor Speech: Percentage of patients aged 16 years and older with a diagnosis of late effects of cerebrovascular disease (CVD) that make progress on the Motor Speech Functional Communication Measure ASH A X

0446/ 213 Clinical Process/ Effective ness Functional Communication Measure – Reading: Percentage of patients aged 16 years and older with a diagnosis of late effects of cerebrovascular disease (CVD) that make progress on the Reading Functional Communication Measure ASH A X

0444/ 214 Clinical Process/ Effective ness Functional Communication Measure - Spoken Language Expression: Percentage of patients aged 16 years and older with a diagnosis of late effects of cerebrovascular disease (CVD) that make progress on the Spoken Language Expression Functional Communication Measure ASH A X

0442/ 215 Clinical Process/ Effective ness Functional Communication Measure – Writing: Percentage of patients aged 16 years and older with a diagnosis of late effects of cerebrovascular disease (CVD) that make progress on the Writing Functional Communication Measure ASH A X

0443/ 216 Clinical Process/ Functional Communication Measure – Swallowing: Percentage of patients aged ASH A X1010

Effective ness 16 years and older with a diagnosis of late effects of cerebrovascular disease (CVD) that make progress on the Swallowing Functional Communication Measure 0422/ 217 Care Coordinat ion Functional Deficit: Change in RiskAdjusted Functional Status for Patients with Knee Impairments: Percentage of patients aged 18 or older that receive treatment for a functional deficit secondary to a diagnosis that affects the knee in which the change in their Risk-Adjusted Functional Status is measured FOT O X

0423/ 218 Care Coordinat ion Functional Deficit: Change in RiskAdjusted Functional Status for Patients with Hip Impairments: Percentage of patients aged 18 or older that receive treatment for a functional deficit secondary to a diagnosis that affects the hip in which the change in their Risk-Adjusted Functional Status is measured FOT O X

0424/ 219 Care Coordinat ion Functional Deficit: Change in RiskAdjusted Functional Status for Patients with Lower Leg, Foot or Ankle Impairments: Percentage of patients aged 18 or older that receive treatment for a functional deficit secondary to a diagnosis that affects the lower leg, foot or ankle in which the change in their Risk-Adjusted Functional Status is measured FOT O X

0425/ 220 Care Coordinat ion Functional Deficit: Change in RiskAdjusted Functional Status for Patients with Lumbar Spine Impairments: Percentage of patients aged 18 or older that receive treatment for a functional deficit secondary to a diagnosis that affects the lumbar spine in which the change in their Risk-Adjusted Functional Status is measured FOT O X

0426/ 221 Care Coordinat ion Functional Deficit: Change in RiskAdjusted Functional Status for Patients with Shoulder Impairments: Percentage of patients aged 18 or older that receive treatment for a functional deficit secondary to a diagnosis that affects the shoulder in which the change in their Risk-Adjusted Functional Status is measured FOT O X

0427/ Care Functional Deficit: Change in Risk- FOT X1011

222 Coordinat ion Adjusted Functional Status for Patients with Elbow, Wrist or Hand Impairments: Percentage of patients aged 18 or older that receive treatment for a functional deficit secondary to a diagnosis that affects the elbow, wrist orhand in which the change in their RiskAdjusted Functional Status is measured O

0428/ 223 Care Coordinat ion Functional Deficit: Change in RiskAdjusted Functional Status for Patients with Neck, Cranium, Mandible, Thoracic Spine, Ribs, or Other General Orthopedic Impairments: Percentage of patients aged 18 or older that receive treatment for a functional deficit secondary to a diagnosis that affects the neck, cranium, mandible, thoracic spine, ribs, or other general orthopedic impairment in which the change in their Risk-Adjusted Functional Status is measured FOT O X

0562/ 224 Efficient Use of Healthcar e Resource s Melanoma: Overutilization of Imaging Studies in Melanoma: Percentage of patients, regardless of age, with a current diagnosis of stage 0 through IIC melanoma or a history of melanoma of any stage, without signs or symptoms suggesting systemic spread,seen for an office visit during the oneyear measurement period, for whom no diagnostic imaging studies were ordered AMA

- PCPI/ NCQ A X

0509/ 225 Care Coordinat ion Radiology: Reminder System for Mammograms: Percentage of patients aged 40 years and older undergoing a screening mammogram whose information is entered into a reminder system with a target due date for the next mammogram AMA

- PCPI/ NCQ A X X

0028/ 226 Populatio n/Public Health Preventive Care and Screening: Tobacco Use: Screening and Cessation Intervention: Percentage of patients 18 years and older who were screened for tobacco use one or more times within 24 months AND who received cessation counseling intervention if identified as a tobacco user AMA -PCPI X X X X X MU1/ MU2 ACO Million Hearts

N/A/ 228 Clinical Process/ Effective ness Heart Failure (HF): Left Ventricular Function (LVF) Testing: Percentage of patients 18 years and older with Left Ventricular Function (LVF) testing performed within the previous 12 months for patients who are hospitalized CMS/ QIP X1012
with a principal diagnosis of Heart Failure (HF) during the reporting period N/A/ 231 Clinical Process/ Effective ness Asthma: Tobacco Use: Screening - Ambulatory Care Setting: Percentage of patients (or their primary caregiver) aged 5 through 50 years with a diagnosis of asthma who were queried about tobacco use and exposure to second hand smoke within their home environment at least once during the one-year measurement period AMA

- PCPI/ NCQ A X X X

N/A/ 232 Clinical Process/ Effective ness Asthma: Tobacco Use: Intervention - Ambulatory Care Setting: Percentage of patients (or their primary caregiver) aged 5 through 50 years with a diagnosis of asthma who were identified as tobacco users (patients who currently use tobacco AND patients who do not currently use tobacco, but are exposed to second hand smoke in their home environment) who received tobacco cessation intervention at least once during the one-year measurement period AMA

- PCPI/ NCQ A X X X

0457/ 233 Clinical Process/ Effective ness Thoracic Surgery: Recording of Performance Status Prior to Lung or Esophageal Cancer Resection: Percentage of patients aged 18 years and older undergoing resection for lung or esophageal cancer who had performance status documented and reviewed within 2 weeks prior to surgery STS X

0458/ 234 Patient Safety Thoracic Surgery: Pulmonary Function Tests Before Major Anatomic Lung Resection (Pneumonectomy, Lobectomy, or Formal Segmentectomy): Percentage of thoracic surgical patients aged 18 years and older undergoing at least one pulmonary function test within 12 months prior to a major lung resection (pneumonectomy, lobectomy, or formal segmentectomy) STS X

0018/ 236 Clinical Process/ Effective ness Hypertension (HTN): Controlling High Blood Pressure: Percentage of patients aged 18 through 85 years of age who had a diagnosis of hypertension (HTN) and whose BP was adequately controlled (< 140/90 mmHg) NCQ A X X X X X MU1/ MU2 ACO Million Hearts 0013/ 237 

### ◊ Clinical Process/ Effective ness Hypertension (HTN): Blood Pressure Measurement: Percentage of patient visits for patients aged 18 years and older with a diagnosis of hypertension AMA -PCPI X MU11013
with blood pressure (BP) recorded 0022/ 238 Patient Safety Drugs to be Avoided in the Elderly: Percentage of patients ages 65 years and older who received at least one drug to be avoided in the elderly and/or two different drugs to be avoided in the elderly in the measurement period NCQ A X MU2

0024/ 239 Populatio n/Public Health Weight Assessment and Counseling for Children and Adolescents: Percentage of children 2 through 17 years of age who had an outpatient visit with a PCP or OB/GYN and who had evidence of BMI percentile documentation, counseling for nutrition and counseling for physical activity during the measurement period NCQ A X MU1/ MU2

0038/ 240 Populatio n/Public Health Childhood Immunization Status: The percentage of children 2 years of age who had four diphtheria, tetanus and acellular pertussis (DTaP); three polio (IPV); one measles, mumps, rubella (MMR); three H influenza type B (HiB); three hepatitis B (Hep B); one chicken pox (VZV); four pneumococcal conjugate (PCV); two hepatitis A (Hep A); two or three rotavirus (RV); and two influenza (flu) vaccines by their second birthday NCQ A X MU1/ MU2

0075/ 241 Clinical Process/ Effective ness Ischemic Vascular Disease (IVD): Complete Lipid Panel and Low Density Lipoprotein (LDL-C) Control: Percentage of patients aged 18 years and older with Ischemic Vascular Disease (IVD) who received at least one lipid profile within 12 months and whose most recent LDL-C level was in control (less than 100 mg/dL) NCQ A X X X X X MU1/ MU2 ACO Million Hearts

N/A/ 242 Clinical Process/ Effective ness Coronary Artery Disease (CAD): Symptom Management: Percentage of patients aged 18 years and older with a diagnosis of coronary artery disease seen within a 12 month period with an evaluation of level of activity and an assessment of whether anginal symptoms are present or absent with appropriate management of anginal symptoms within a 12 month period AMA

- PCPI/ ACC F/AH A X X

0643/ 243 Clinical Process/ Effective ness Cardiac Rehabilitation Patient Referral from an Outpatient Setting: Percentage of patients evaluated in an outpatient setting who within the previous 12 months have experienced an ACCFAHA X1014
acute myocardial infarction (MI), coronary artery bypass graft (CABG) surgery, a percutaneous coronary intervention (PCI), cardiac valve surgery, or cardiac transplantation, or who have chronic stable angina (CSA) and have not already participated in an early outpatient cardiac rehabilitation/secondary prevention (CR) program for the qualifying event/diagnosis who were referred to a CR program N/A/ 244 Clinical Process/ Effective ness Hypertension: Blood Pressure Management: Percentage of patients aged 18 years and older with a diagnosis of hypertension seen within a 12 month period with a blood pressure < 140/90 mmHg OR patients with a blood pressure ≥ 140/90 mmHg and prescribed two or more anti-hypertensive medications during the most recent office visit AMA

- PCPI/ ACC F/AH A X

AQA adopt ed/ 245 Clinical Process/ Effective ness Chronic Wound Care: Use of Wound Surface Culture Technique in Patients with Chronic Skin Ulcers (Overuse Measure): Percentage of patient visits for those patients aged 18 years and older with a diagnosis of chronic skin ulcer without the use of a wound surface culture technique AMA

- PCPI/ NCQ A X X

AQA adopt ed/ 246 Clinical Process/ Effective ness Chronic Wound Care: Use of Wet to Dry Dressings in Patients with Chronic Skin Ulcers (Overuse Measure): Percentage of patient visits for those patients aged 18 years and older with a diagnosis of chronic skin ulcer without a prescription or recommendation to use wet to dry dressings AMA

- PCPI/ NCQ A X X

AQA adopt ed/ 247 Clinical Process/ Effective ness Substance Use Disorders: Counseling Regarding Psychosocial and Pharmacologic Treatment Options for Alcohol Dependence: Percentage of patients aged 18 years and older with a diagnosis of current alcohol dependence who were counseled regarding psychosocial AND pharmacologic treatment options for alcohol dependence within the 12-month reporting period AMA

- PCPI/ NCQ A X X

AQA adopt Clinical Process/ Substance Use Disorders: Screening for Depression Among Patients with AMA

- X X1015

ed/ 248 Effective ness Substance Abuse or Dependence: Percentage of patients aged 18 years and older with a diagnosis of current substance abuse or dependence who were screened for depression within the 12-month reporting period PCPI/ NCQ A

N/A/ 249 Clinical Process/ Effective ness Barrett's Esophagus: Percentage of esophageal biopsy reports that document the presence of Barrett’s mucosa that also include a statement about dysplasia CAP X X

N/A/ 250 Clinical Process/ Effective ness Radical Prostatectomy Pathology Reporting: Percentage of radical prostatectomy pathology reports that include the pT category, the pN category, the Gleason score and a statement about margin status CAP X X

N/A/ 251 Clinical Process/ Effective ness Immunohistochemical (IHC) Evaluation of Human Epidermal Growth Factor Receptor 2 Testing (HER2) for Breast Cancer Patients: This is a measure based on whether quantitative evaluation of Human Epidermal Growth Factor Receptor 2 Testing (HER2) by immunohistochemistry (IHC) uses the system recommended in the ASCO/CAP Guidelines for Human Epidermal Growth Factor Receptor 2 Testing in breast cancer CAP X X

0503/ 252 Clinical Process/ Effective ness Anticoagulation for Acute Pulmonary Embolus Patients: Anticoagulation ordered for patients who have been discharged from the emergency department (ED) with a diagnosis of acute pulmonary embolus ACEP X X

0651/ 254 Clinical Process/ Effective ness Ultrasound Determination of Pregnancy Location for Pregnant Patients with Abdominal Pain: Percentage of pregnant female patients aged 14 to 50 who present to the emergency department (ED) with a chief complaint of abdominal pain or vaginal bleedingwho receive a trans-abdominal or transvaginal ultrasound to determine pregnancy location ACEP X X

0652/ 255 Clinical Process/ Effective ness Rh Immunoglobulin (Rhogam) for Rh-Negative Pregnant Women at Risk of Fetal Blood Exposure: Percentage of Rh-negative pregnant women aged 14- 50 years at risk of fetal blood exposure who receive Rh-Immunoglobulin ACEP X X1016
(Rhogam) in the emergency department (ED) N/A/ 256 Care Coordinat ion Surveillance after Endovascular Abdominal Aortic Aneurysm Repair (EVAR): Percentage of patients 18 years of age or older undergoing endovascular abdominal aortic aneurysm repair (EVAR) who have at least one follow-up imaging study after 3 months and within 15 months of EVAR placement that documents aneurysm sac diameter and endoleak status SVS X

N/A/ 257 Clinical Process/ Effective ness Statin Therapy at Discharge after Lower Extremity Bypass (LEB): Percentage of patients aged 18 years and older undergoing infra-inguinal lower extremity bypass who are prescribed a statin medication at discharge SVS X

N/A/ 258 Care Coordinat ion Rate of Open Repair of Small or Moderate Non-Ruptured Abdominal Aortic Aneurysms (AAA) without Major Complications (Discharged to Home by Post-Operative Day #7): Percent of patients undergoing openrepair of small or moderate sized nonruptured abdominal aortic aneurysms who do not experience a major complication (discharge to home no later than post-operative day #7) SVS X

N/A/ 259 Care Coordinat ion Rate of Endovascular Aneurysm Repair (EVAR) of Small or Moderate Non-Ruptured Abdominal Aortic Aneurysms (AAA) without Major Complications (Discharged to Home by Post-Operative Day #2): Percent of patients undergoing endovascular repair of small or moderate non-ruptured abdominal aortic aneurysms (AAA) that do not experience a major complication(discharged to home no later than postoperative day #2) SVS X

N/A/ 260 Care Coordinat ion Rate of Carotid Endarterectomy (CEA) for Asymptomatic Patients, without Major Complications(Discharged to Home by PostOperative Day #2): Percent of asymptomatic patients undergoing CEA who are discharged to home no later than post-operative day #2 SVS X

N/A/ 261 Care Coordinat ion Referral for Otologic Evaluation for Patients with Acute or Chronic Dizziness: Percentage of patients aged AQC X X1017
birth and older referred to a physician (preferably a physician specially trained in disorders of the ear) for an otologic evaluation subsequent to an audiologic evaluation after presenting with acute or chronic dizziness N/A/ 262 Patient Safety Image Confirmation of Successful Excision of Image–Localized Breast Lesion: Image confirmation of lesion(s) targeted for image guided excisional biopsy or image guided partial mastectomy in patients with nonpalpable, image-detected breast lesion(s). Lesions may include: microcalcifications, mammographic or sonographic mass or architectural distortion, focal suspicious abnormalities on magnetic resonance imaging ( MRI) or other breast imaging amenable to localization such as positron emission tomography (PET) mammography, or a biopsy marker demarcating site of confirmed pathology as established by previous core biopsy. ASBS X X

N/A/ 263 Clinical Process/ Effective ness Preoperative Diagnosis of Breast Cancer: The percent of patients undergoing breast cancer operations who obtained the diagnosis of breast cancer preoperatively by a minimally invasive biopsy method ASBS X X

N/A/ 264 Clinical Process/ Effective ness Sentinel Lymph Node Biopsy for Invasive Breast Cancer: The percentage of clinically node negative (clinical stage T1N0M0 or T2N0M0) breast cancer patients who undergo a sentinel lymph node (SLN) procedure ASBS X

0645/ 265 Care Coordinat ion Biopsy Follow-Up: Percentage of new patients whose biopsy results have been reviewed and communicated to the primary care/referring physician and patient by the performing physician AAD X

N/A/ 266 Clinical Process/ Effective ness Epilepsy: Seizure Type(s) and Current Seizure Frequency(ies): Percentage of patient visits with a diagnosis of epilepsy who had the type(s) of seizure(s) and current seizure frequency(ies) for each seizure type documented in the medical record AAN X X

N/A/ 267 Clinical Process/ Effective ness Epilepsy: Documentation of Etiology of Epilepsy or Epilepsy Syndrome: All visits for patients with a diagnosis of epilepsy who had their etiology of AAN X X1018
epilepsy or with epilepsy syndrome(s) reviewed and documented if known, or documented as unknown or cryptogenic N/A/ 268 Clinical Process/ Effective ness Epilepsy: Counseling for Women of Childbearing Potential with Epilepsy: All female patients of childbearing potential (12-44 years old) diagnosed with epilepsy who were counseled about epilepsy and how its treatment may affect contraception and pregnancy at least once a year AAN X X

N/A/ 269 Clinical Process/ Effective ness Inflammatory Bowel Disease (IBD): Type, Anatomic Location and Activity All Documented: Percentage of patients aged 18 years and older with a diagnosis of inflammatory bowel disease who have documented the disease type, anatomic location and activity, at least once during the reporting period AGA X

N/A/ 270 Clinical Process/ Effective ness Inflammatory Bowel Disease (IBD): Preventive Care: Corticosteroid Sparing Therapy: Percentage of patients aged 18 years and older with a diagnosis of inflammatory bowel disease who have been managed by corticosteroids greater than or equal to 10 mg/day for 60 or greater consecutive days that have been prescribed corticosteroid sparing therapy in the last reporting year AGA X

N/A/ 271 Clinical Process/ Effective ness Inflammatory Bowel Disease (IBD): Preventive Care: Corticosteroid Related Iatrogenic Injury – Bone Loss Assessment: Percentage of patients aged 18 years and older with a diagnosis of inflammatory bowel disease who have received dose of corticosteroids greater than or equal to 10 mg/day for 60 or greater consecutive days and were assessed for risk of bone loss once per the reporting year AGA X

N/A/ 272 Clinical Process/ Effective ness Inflammatory Bowel Disease (IBD): Preventive Care: Influenza Immunization: Percentage of patients aged 18 years and older with a diagnosis of inflammatory bowel disease for whom influenza immunization was recommended, administered or previously received during the reporting year AGA X

N/A/ Clinical Inflammatory Bowel Disease (IBD): AGA X1019

273 Process/ Effective ness Preventive Care: Pneumococcal Immunization: Percentage of patients aged 18 years and older with a diagnosis of inflammatory bowel disease that had pneumococcal vaccination administered or previously received N/A/ 274 Clinical Process/ Effective ness Inflammatory Bowel Disease (IBD): Testing for Latent Tuberculosis (TB) Before Initiating Anti-TNF (Tumor Necrosis Factor) Therapy: Percentage of patients aged 18 years and older with a diagnosis of inflammatory bowel disease for whom a tuberculosis (TB) screening was performed and results interpreted within 6 months prior to receiving a first course of anti-TNF (tumor necrosis factor) therapy AGA X

N/A/ 275 Clinical Process/ Effective ness Inflammatory Bowel Disease (IBD): Assessment of Hepatitis B Virus(HBV) Status Before Initiating AntiTNF (Tumor Necrosis Factor) Therapy: Percentage of patients aged 18 years and older with a diagnosis of inflammatory bowel disease who had Hepatitis B Virus (HBV) status assessed and results interpreted within one yearprior to receiving a first course of antiTNF (tumor necrosis factor) therapy AGA X

N/A/ 276 Clinical Process/ Effective ness Sleep Apnea: Assessment of Sleep Symptoms: Percentage of visits for patients aged 18 years and older with a diagnosis of obstructive sleep apnea that includes documentation of an assessment of symptoms, including presence or absence of snoring and daytime sleepiness AMA

- PCPI/ NCQ A X

N/A/ 277 Clinical Process/ Effective ness Sleep Apnea: Severity Assessment at Initial Diagnosis: Percentage of patients aged 18 years and older with a diagnosis of obstructive sleep apnea who had an apnea hypopnea index (AHI) or a respiratory disturbance index (RDI) measured at the time of initial diagnosis AMA

- PCPI/ NCQ A X

N/A/ 278 Clinical Process/ Effective ness Sleep Apnea: Positive Airway Pressure Therapy Prescribed: Percentage of patients aged 18 years and older with a diagnosis of moderate or severe obstructive sleep apnea who were prescribed positive airway pressure therapy AMA

- PCPI/ NCQ A X

N/A/ 279 Clinical Process/ Sleep Apnea: Assessment of Adherence to Positive Airway AMA

- X1020

Effective ness Pressure Therapy: Percentage of visits for patients aged 18 years and older with a diagnosis of obstructive sleep apnea who were prescribed positive airway pressure therapy who had documentation that adherence to positive airway pressure therapy was objectively measured PCPI/ NCQ A

N/A/ 280 Care Coordinat ion Dementia: Staging of Dementia: Percentage of patients, regardless of age, with a diagnosis of dementia whose severity of dementia was classified as mild, moderate or severe at least once within a 12 month period AMA -PCPI X

N/A/ 281 Clinical Process/ Effective ness Dementia: Cognitive Assessment: Percentage of patients, regardless of age, with a diagnosis of dementia for whom an assessment of cognition is performed and the results reviewed at least once within a 12 month period AMA -PCPI X MU2

N/A/ 282 Clinical Process/ Effective ness Dementia: Functional Status Assessment: Percentage of patients, regardless of age, with a diagnosis of dementia for whom an assessment of patient’s functional status is performed and the results reviewed at least once within a 12 month period AMA -PCPI X

N/A/ 283 Clinical Process/ Effective ness Dementia: Neuropsychiatric Symptom Assessment: Percentage of patients, regardless of age, with a diagnosis of dementia and for whom an assessment of patient’s neuropsychiatric symptoms is performed and results reviewed at least once in a 12 month period AMA -PCPI X

N/A/ 284 Clinical Process/ Effective ness Dementia: Management of Neuropsychiatric Symptoms: Percentage of patients, regardless of age, with a diagnosis of dementia who have one or more neuropsychiatric symptoms who received or were recommended to receive an intervention for neuropsychiatric symptoms within a 12 month period AMA -PCPI X

N/A/ 285 Clinical Process/ Effective ness Dementia: Screening for Depressive Symptoms: Percentage of patients, regardless of age, with a diagnosis of dementia who were screened for depressive symptoms within a 12 month period AMA -PCPI X

N/A/ 286 Patient Safety Dementia: Counseling Regarding Safety Concerns: Percentage of patients, regardless of age, with a AMA -PCPI X1021
diagnosis of dementia or their caregiver(s) who were counseled or referred for counseling regarding safety concerns within a 12 month period N/A/ 287 Clinical Process/ Effective ness Dementia: Counseling Regarding Risks of Driving: Percentage of patients, regardless of age, with a diagnosis of dementia or their caregiver(s) who were counseled regarding the risks of driving and the alternatives to driving at least once within a 12 month period AMA -PCPI X

N/A/ 288 Clinical Process/ Effective ness Dementia: Caregiver Education and Support: Percentage of patients, regardless of age, with a diagnosis of dementia whose caregiver(s) were provided with education on dementia disease management and health behavior changes AND referred to additional sources for support within a 12 month period AMA -PCPI X

N/A/ 289 Clinical Process/ Effective ness Parkinson’s Disease: Annual Parkinson’s Disease Diagnosis Review: All patients with a diagnosis of Parkinson’s disease who had an annual assessment including a review of current medications (e.g., medications than can produce Parkinson-like signs or symptoms) and a review for the presence of atypical features (e.g., falls at presentation and early in the disease course, poor response to levodopa, symmetry at onset, rapid progression [to Hoehn and Yahr stage 3 in 3 years], lack of tremor or dysautonomia) at least annually AAN X

N/A/ 290 Clinical Process/ Effective ness Parkinson’s Disease: Psychiatric Disorders or Disturbances Assessment: All patients with a diagnosis of Parkinson’s disease who were assessed for psychiatric disorders or disturbances (e.g., psychosis, depression, anxiety disorder, apathy, or impulse control disorder) at least annually AAN X

N/A/ 291 Clinical Process/ Effective ness Parkinson’s Disease: Cognitive Impairment or Dysfunction Assessment: All patients with a diagnosis of Parkinson’s disease who were assessed for cognitive impairment or dysfunction at least annually AAN X

N/A/ Clinical Parkinson’s Disease: Querying about AAN X1022

292 Process/ Effective ness Sleep Disturbances: All patients with a diagnosis of Parkinson’s disease (or caregivers, as appropriate) who were queried about sleep disturbances at least annually N/A/ 293 Clinical Process/ Effective ness Parkinson’s Disease: Rehabilitative Therapy Options: All patients with a diagnosis of Parkinson’s disease (or caregiver(s), as appropriate) who had rehabilitative therapy options (e.g., physical, occupational, or speech therapy) discussed at least annually AAN X

N/A/ 294 Clinical Process/ Effective ness Parkinson’s Disease: Parkinson’s Disease Medical and Surgical Treatment Options Reviewed: All patients with a diagnosis of Parkinson’s disease (or caregiver(s), as appropriate who had the Parkinson’s diseasetreatment options (e.g., nonpharmacological treatment, pharmacological treatment, or surgical treatment) reviewed at least once annually AAN X

N/A/ 295 Clinical Process/ Effective ness Hypertension: Appropriate Use of Aspirin or Other Antithrombotic Therapy: Percentage of patients aged 30 through 90 years old with a diagnosis of hypertension and are eligible for asprin or other antithrombotic therapy who were prescribed aspirin or other antithrombotic therapy ABI M X

N/A/ 296 Clinical Process/ Effective ness Hypertension: Complete Lipid Profile: Percentage of patients aged 18 through 90 years old with a diagnosis of hypertension who received a complete lipid profile within 60 months ABI M X

N/A/ 297 Clinical Process/ Effective ness Hypertension: Urine Protein Test: Percentage of patients aged 18 through 90 years old with a diagnosis of hypertension who either have chronic kidney disease diagnosis documented or had a urine protein test done within 36 months ABI M X

N/A/ 298 Clinical Process/ Effective ness Hypertension: Annual Serum Creatinine Test: Percentage of patients aged 18 through 90 years old with a diagnosis of hypertension who had a serum creatinine test done within 12 months ABI M X

N/A/ 299 Clinical Process/ Effective Hypertension: Diabetes Mellitus Screening Test: Percentage of patients aged 18 through 90 years old with a ABI M X1023
ness diagnosis of hypertension who had a diabetes screening test within 36 months N/A/ 300 Clinical Process/ Effective ness Hypertension: Blood Pressure Control: Percentage of patients aged 18 through 90 years old with a diagnosis of hypertension who had most recent blood pressure level under control (at goal) ABI M X

N/A/ 301 Clinical Process/ Effective ness Hypertension: Low Density Lipoprotein (LDL-C) Control: Percentage of patients aged 18 through 90 years old with a diagnosis of hypertension who had most recent LDL cholesterol level under control (at goal) ABI M X

N/A/ 302 Clinical Process/ Effective ness Hypertension: Dietary and Physical Activity Modifications Appropriately Prescribed: Percentage of patients aged 18 through 90 years old with a diagnosis of hypertension who received dietary and physical activity counseling at least once within 12 months ABI M X

N/A/ 303 Clinical Process/ Effective ness Cataracts: Improvement in Patient’s Visual Function within 90 Days Following Cataract Surgery: Percentage of patients aged 18 years and older in sample who had cataract surgery and had improvement in visual function achieved within 90 days following the cataract surgery, based on completing a pre-operative and post-operative visual function survey AAO X X

N/A/ 304 Patient and Family Engagem ent Cataracts: Patient Satisfaction within 90 Days Following Cataract Surgery: Percentage of patients aged 18 years and older in sample who had cataract surgery and were satisfied with their care within 90 days following the cataract surgery, based on completion of the Consumer Assessment of Healthcare Providers and Systems Surgical Care Survey AAO X X

0004/ 305 Clinical Process/ Effective ness Initiation and Engagement of Alcohol and Other Drug Dependence Treatment: (a) Initiation, (b) Engagement: Percentage of adolescent and adult patients with a new episode of alcohol or other drug (AOD) dependence who initiate treatment through an inpatient AOD admission, outpatient visit, intensive outpatient encounter or partial hospitalization within 14 days of the diagnosis and who initiated treatment AND who had two or more additional services with an AOD diagnosis within NCQ A X MU1/ MU21024
30 days of the initial visit 0012/ 306 

### ◊ Populatio n/Public Health Prenatal Care: Screening for Human Immunodeficiency Virus (HIV): Percentage of patients, regardless of age, who gave birth during a 12-month period who were screened for HIV infection during the first or second prenatal visit AMA -PCPI X MU1

0014/ 307 

### ◊ Patient Safety Prenatal Care: Anti-D Immune Globulin: Percentage of D (Rh) negative, unsensitized patients, regardless of age, who gave birth during a 12-month period who received anti-D immune globulin at 26-30 weeks gestation AMA -PCPI X MU1

0027/ 308 

### ◊ Populatio n/Public Health Smoking and Tobacco Use Cessation, Medical Assistance: a. Advising Smokers and Tobacco Users to Quit, b. Discussing Smoking and Tobacco Use Cessation Medications, c. Discussing Smoking and Tobacco Use Cessation Strategies: Percentage of patients aged 18 years and older who were current smokers or tobacco users, who were seen by a practitioner during the measurement year and who received advice to quit smoking or tobacco use or whose practitioner recommended or discussed smoking or tobacco use cessation medications, methods or strategies NCQ A X MU1

0032/ 309 Clinical Process/ Effective ness Cervical Cancer Screening: Percentage of women aged 21 through 63 years who received one or more Pap tests to screen for cervical cancer NCQ A X MU1/ MU2

0033/ 310 Populatio n/Public Health Chlamydia Screening for Women: Percentage of women aged 15 through 24 years who were identified as sexually active and who had at least one test for chlamydia during the measurement year NCQ A X MU1/ MU2

0036/ 311 Clinical Process/ Effective ness Use of Appropriate Medications for Asthma: Percentage of patients aged 5 through 50 years of age who were identified as having persistent asthma and were appropriately prescribed medication during the measurement year NCQ A X MU1/ MU2

0052/ 312 Efficient Use of Healthcar e Resource s Low Back Pain: Use of Imaging Studies: Percentage of patients with a primary diagnosis of low back pain whodid not have an imaging study (plain Xray, MRI, CT scan) within 28 days of diagnosis NCQ A X MU1/ MU21025

0575/ 313 

### ◊ Clinical Process/ Effective ness Diabetes Mellitus: Hemoglobin A1c Control (< 8%): The percentage of patients 18 through 75 years of age with a diagnosis of diabetes (type 1 or type 2) who had HbA1c < 8% NCQ A X MU1

N/A/ 316 Clinical Process/ Effective ness Preventive Care and Screening: Cholesterol – Fasting Low Density Lipoprotein (LDL) Test Performed AND Risk-Stratified Fasting LDL: Percentage of patients aged 20 through 79 years whose risk factors* have been assessed and a fasting LDL test has been performed *There are three criteria for this measure based on the patient’s risk category. 1. Highest Level of Risk: Coronary Heart Disease (CHD) or CHD Risk Equivalent 2. Moderate Level of Risk: Multiple (2+) Risk Factors 3. Lowest Level of Risk: 0 or 1 Risk Factor CMS/ QIP X MU2 Million Hearts

N/A/ 317 Populatio n/Public Health Preventive Care and Screening: Screening for High Blood Pressure and Follow-Up Documented: Percentage of patients aged 18 years and older seen during the reporting period who were screened for high blood pressure (BP) AND a recommended follow-up plan is documented based on the current blood pressure reading as indicated CMS/ QIP X X X X X MU2 ACO Million Hearts

0101/ 318 Patient Safety Falls: Screening for Future Fall Risk: Percentage of patients aged 65 years and older who were screened for future fall risk at least once within the reporting period AMA

- PCPI/ NCQ A X MU2 ACO

0729/ TBD 

### ‡ Clinical Process/ Effective ness Diabetes Composite: Optimal Diabetes Care: Patients ages 18 through 75 with a diagnosis of diabetes, who meet all the numerator targets of this composite measure:

• A1c < 8.0%,

• LDL < 100 mg/dL,

• blood pressure < 140/90 mmHg,

• tobacco non-user and

• for patients with a diagnosis of ischemic vascular disease daily aspirin use unless contraindicated MNC M X ACO

0658/ TBD 

### ‡ Care Coordinat Endoscopy/Polyp Surveillance: Appropriate Follow-Up Interval for AMA -PCPI X X1026

ion Normal Colonoscopy in Average Risk Patients: Percentage of patients aged 50 years and older receiving a screening colonoscopy without biopsy or polypectomy who had a recommended follow-up interval of at least 10 years for repeat colonoscopy documented in their colonoscopy report 0493/ TBD 

### ‡ Care Coordinat ion Participation by a Hospital, Physician or Other Clinician in a Systematic Clinical Database Registry that Includes Consensus Endorsed Quality: Participation in a systematic qualified clinical database registry involves: a. Physician or other clinician submits standardized data elements to registry. b. Data elements are applicable to consensus endorsed quality measures. c. Registry measures shall include at least two (2) representative NQF consensus endorsed measures for registry's clinical topic(s) and report on all patients eligible for the selected measures. d. Registry provides calculated measures results, benchmarking, and quality improvement information to individual physicians and clinicians. e. Registry must receive data from more than 5 separate practices and may not be located (warehoused) at an individual group’s practice. Participation in a national or state-wide registry is encouraged for this measure. f. Registry may provide feedback directly to the provider’s local registry if one exists. OFM Q X X

0005 & 0006/ TBD 

### ‡ Care Coordinat ion CG-CAHPS Clinician/Group Survey

• Getting timely care, appointments and information

• How well your doctors communicate

• Patients rating of doctor

• Access to specialists

• Health promotion and education

• Shared decision making

• Health status/Functional status ASPE X ACO

0670/ TBD 

### ‡ Efficient Use of Healthcar e Cardiac Stress Imaging Not Meeting Appropriate Use Criteria: Preoperative Evaluation in Low-Risk Surgery Patients: Percentage of stress ACC X1027

Resource s single-photon emission computed tomography (SPECT) myocardial perfusion imaging (MPI), stress echocardiogram (ECHO), cardiac computed tomography angiography (CCTA), or cardiac magnetic resonance (CMR) performed in low risk surgery patients 18 years or older for preoperative evaluation during the 12- month reporting period 0671/ TBD 

### ‡ Efficient Use of Healthcar e Resource s Cardiac Stress Imaging Not Meeting Appropriate Use Criteria: Routine Testing After Percutaneous Coronary Intervention (PCI): Percentage of all stress single-photon emission computed tomography (SPECT) myocardial perfusion imaging (MPI), stress echocardiogram (ECHO), cardiac computed tomography angiography (CCTA), and cardiovascular magnetic resonance (CMR) performed in patients aged 18 years and older routinely after percutaneous coronary intervention (PCI), with reference to timing of test after PCI and symptom status ACC X

0672/ TBD 

### ‡ Efficient Use of Healthcar e Resource s Cardiac Stress Imaging Not Meeting Appropriate Use Criteria: Testing in Asymptomatic, Low-Risk Patients: Percentage of all stress single-photon emission computed tomography (SPECT) myocardial perfusion imaging (MPI), stress echocardiogram (ECHO), cardiac computed tomography angiography (CCTA), and cardiovascular magnetic resonance (CMR) performed in asymptomatic, low coronary heart disease (CHD) risk patients 18 years and older for initial detection and risk assessment ACC X

TBD/ TBD 

### ‡ Clinical Process/ Effective ness Adult Major Depressive Disorder (MDD): Coordination of Care of Patients with Specific Comorbid Conditions: Percentage of medical records of patients aged 18 years and older with a diagnosis of major depressive disorder (MDD) and a specific diagnosed comorbid condition (diabetes, coronary artery disease, ischemic stroke, intracranial hemorrhage, chronic kidney disease [stages 4 or 5], ESRD or congestive heart failure) being treated by another AMA -PCPI X1028

clinician with communication to the other clinician treating the comorbid condition 1525/ TBD 

### ‡ Patient Safety Atrial Fibrillation and Atrial Flutter: Chronic Anticoagulation Therapy: Patients aged 18 and older with a diagnosis of nonvalvular AF or atrial flutter whose assessment of specified thromboembolic risk factors indicate one or more high-risk factors or more than one moderate risk factor, as determined by CHADS2 risk stratification, who are prescribed warfarin OR another oral anticoagulant drug that is FDA approved for the prevention of thromboembolism AMA

- PCPI/ ACC F/AH A X X

TBD/ TBD 

### ‡ Clinical Process/ Effective ness Pediatric Kidney Disease: Adequacy of Volume Management: Percentage of calendar months within a 12-month period during which patients aged 17 years and younger with a diagnosis of End Stage Renal Disease (ESRD) undergoing maintenance hemodialysis in an outpatient dialysis facility have an assessment of the adequacy of volume management from a nephrologist AMA X X

1667/ TBD 

### ‡ Clinical Process/ Effective ness Pediatric Kidney Disease: ESRD Patients Receiving Dialysis: Hemoglobin Level < 10 g/dL: Percentage of calendar months within a 12-month period during which patients aged 17 years and younger with a diagnosis of End Stage Renal Disease (ESRD) receiving hemodialysis or peritoneal dialysis have a hemoglobin level < 10 g/dL AMA -PCPI X X

N/A/ TBD 

### ○ Care Coordinat ion Total Knee Replacement: Coordination of Post Discharge Care: Percentage of patients undergoing total knee replacement who received written instructions for post discharge care including all the following: post discharge physical therapy, home health care, post discharge deep vein thrombosis (DVT) prophylaxis and follow-up physician visits AAH KS/AMAPCPI X

N/A/ TBD 

### ○ Patient Safety Total Knee Replacement: Venous Thromboembolic and Cardiovascular Risk Evaluation: Percentage of patients undergoing a total knee replacement who are evaluated for the presence or absence of venous thromboembolic and cardiovascular risk factors within 30 AAH KS/AMAPCPI X1029
days prior to the procedure including history of deep vein thrombosis (DVT), pulmonary embolism (PE), myocardial infarction (MI), arrhythmia and stroke N/A/ TBD 

### ○ Patient Safety Total Knee Replacement: Preoperative Antibiotic Infusion with Proximal Tourniquet: Percentage of patients undergoing a total knee replacement who had the prophylactic antibiotic completely infused prior to the inflation of the proximal tourniquet AAH KS/AMAPCPI) X

N/A/ TBD 

### ○ Patient Safety Total Knee Replacement: Identification of Implanted Prosthesis in Operative Report: Percentage of patients undergoing total knee replacement whose operative report identifies the prosthetic implant specifications including the prosthetic implant manufacturer, the brand name of prosthetic implant and the size of prosthetic implant AAH KS/AMAPCPI X

TBD/ TBD 

### ○ Care Coordinat ion Optimizing Patient Exposure to Ionizing Radiation: Utilization of a Standardized Nomenclature for CT Imaging Description: Percentage of computed tomography (CT) imaging reports for all patients, regardless of age, with the imaging study named according to a standardized nomenclature (e.g., RadLex®) and the standardized nomenclature is used in institutions computer systems AMA -PCPI X

TBD/ TBD 

### ○ Patient Safety Optimizing Patient Exposure to Ionizing Radiation : Count of Potential High Dose Radiation Imaging Studies: Computed Tomography (CT) Scans and Cardiac Nuclear Medicine Scans: Percentage of CT and cardiac nuclear medicine (myocardial perfusion studies) imaging reports for all patients, regardless of age, that document a count of known previous CT studies (any type of CT) and cardiac nuclear medicine (myocardial perfusion studies) studies that the patient has received in the 12- month period prior to the current study AMA -PCPI X

TBD/ TBD 

### ○ Patient Safety Optimizing Patient Exposure to Ionizing Radiation: Reporting to a Radiation Dose Index Registry: Percentage of total computed tomography (CT) studies performed for AMA -PCPI X1030
all patients, regardless of age, that are reported to a radiation dose index registry AND that include at a minimum selected data elements TBD/ TBD 

### ○ Care Coordinat ion Optimizing Patient Exposure to Ionizing Radiation: CT Images Available for Patient Follow-up and Comparison Purposes: Percentage of final reports for computed tomography (CT) studies performed for all patients, regardless of age, which document that Digital Imaging and Communications in Medicine (DICOM) format image data are available to non-affiliated external entities on a secure, media free, reciprocally searchable basis with patient authorization for at least a 12- month period after the study AMA -PCPI X

TBD/ TBD 

### ○ Care Coordinat ion Optimizing Patient Exposure to Ionizing Radiation: Search for Prior Imaging Studies Through a Secure, Authorized, Media-Free, Shared Archive: Percentage of final reports of computed tomography (CT) studies performed for all patients, regardless of age, which document that a search for Digital Imaging and Communications in Medicine (DICOM) format images was conducted for prior patient imaging studies completed at non-affiliated external entities within the past 12- months and are available through a secure, authorized, media free, shared archive prior to an imaging study being performed AMA -PCPI X

N/A/ TBD 

### ○ Clinical Process/ Effective ness Osteoporosis: Status of Participation in Weight-Bearing Exercise and Weight-bearing Exercise Advice: Percentage of patients aged 18 and older with a diagnosis of osteoporosis, osteopenia, or prior low impact fracture; women age 65 and older; or men age 70 and older whose status regarding participation in weight-bearing exercise was documented and for those not participating regularly who received advice within 12 months to participate in weight-bearing exercise ABI M X

N/A/ TBD 

### ○ Clinical Process/ Effective ness Osteoporosis: Current Level of Alcohol Use and Advice on Potentially Hazardous Drinking Prevention: Percentage of patients aged 18 and older ABI M X1031
with a diagnosis of osteoporosis, osteopenia, or prior low impact fracture; women age 65 and older; or men age 70 and older whose current level of alcohol use was documented and for those engaging in potentially hazardous drinking who received counseling within 12 months N/A/ TBD 

### ○ Patient Safety Osteoporosis: Screen for Falls Risk Evaluation and Complete Falls Risk Assessment and Plan of Care: Percentage of patients aged 18 and older with a diagnosis of osteoporosis, osteopenia, or prior low impact fracture; women age 65 and older; or men age 70 and older who had a screen for falls risk evaluation within the past 12 months and for those reported as having a history of two or more falls, or fall-related injury who had a complete risk assessment for falls and a falls plan of care within the past 12 months ABI M X

N/A/ TBD 

### ○ Care Coordinat ion Osteoporosis: Dual-Emission X-ray Absorptiometry (DXA) Scan: Percentage of patients aged 18 and older with a diagnosis of osteoporosis, osteopenia, or prior low impact fracture; women age 65 and older; or men age 70 and older who had a DXA scan and result documented ABI M X

N/A/ TBD 

### ○ Clinical Process/ Effective ness Osteoporosis: Calcium Intake Assessment and Counseling: Percentage of patients aged 18 and older with a diagnosis of osteoporosis, osteopenia, or prior low impact fracture; women age 65 and older; or men age 70 and older who had calcium intake assessment and counseling at least once within 12 months ABI M X

N/A/ TBD 

### ○ Clinical Process/ Effective ness Osteoporosis: Vitamin D Intake Assessment and Counseling: Percentage of patients aged 18 and older with a diagnosis of osteoporosis, osteopenia, or prior low impact fracture; women age 65 and older; or men age 70 and older who had vitamin D intake assessment and counseling at least once within 12 months ABI M X

N/A/ TBD 

### ○ Clinical Process/ Effective ness Osteoporosis: Pharmacologic Therapy: Percentage of patients aged 18 and older with a diagnosis of osteoporosis, osteopenia, or prior low ABI M X1032
impact fracture; women age 65 and older; or men age 70 and older who were prescribed pharmacologic therapy approved by the Food and Drug Administration N/A/ TBD 

### ○ Clinical Process/ Effective ness Preventive Cardiology Composite: Blood Pressure at Goal: Percentage of patients in the sample whose most recent blood pressure reading was at goal ABI M X

N/A/ TBD 

### ○ Clinical Process/ Effective ness Preventive Cardiology Composite: Low Density Lipids (LDL) Cholesterol at Goal: Percentage of patients in the sample whose LDL cholesterol is considered to be at goal, based upon their coronary heart disease (CHD) risk factors ABI M X

N/A/ TBD 

### ○ Clinical Process/ Effective ness Preventive Cardiology Composite: Timing of Lipid Testing Complies with Guidelines: Percentage of patients in the sample whose timing of lipid testing complies with guidelines (lipid testing performed in the preceding 12- month period (with a 3-month grace period) for patients with known coronary heart disease (CHD) or CHD risk equivalent (prior myocardial infarction (MI), other clinical CHD, symptomatic carotid artery disease, peripheral artery disease, abdominal aortic aneurysm, diabetes mellitus); or in the preceding 24-month period (with a 3-month grace period) for patients with > 2 risk factors for CHD (smoking, hypertension, low high density lipid (HDL), men > 45 years, women > 55 years, family history of premature CHD; HDL > 60 mg/dL acts as a negative risk factor); or in the preceding 60-month period (with a 3-month grace period) for patients with < 1 risk factor for CHD) ABI M X

N/A/ TBD 

### ○ Clinical Process/ Effective ness Preventive Cardiology Composite: Diabetes Documentation or Screen Test: Percentage of patients in the sample who had a screening test for type 2 diabetes or had a diagnosis of diabetes ABI M X

N/A/ TBD 

### ○ Clinical Process/ Effective ness Preventive Cardiology Composite: Correct Determination of Ten-Year Risk for Coronary Death or Myocardial Infarction (MI): Number of patients in the sample whose ten-year risk of coronary death or MI is correctly assessed and documented ABI M X1033

N/A/ TBD 

### ○ Clinical Process/ Effective ness Preventive Cardiology Composite: Counseling for Diet and Physical Activity: Percentage of patients in the sample who received dietary and physical activity counseling ABI M X

N/A/ TBD 

### ○ Clinical Process/ Effective ness Preventive Cardiology Composite: Appropriate Use of Aspirin or Other Antiplatelet/Anticoagulant Therapy: Percentage of patients in the sample who are: 1) taking aspirin or other anticoagulant/antiplatelet therapy, or 2) under age 30, or 3) age 30 or older and who are documented to be at low risk. Low-risk patients include those who are documented with no prior coronary heart disease (CHD) or CHD risk equivalent (prior myocardial infarction (MI), other clinical CHD, symptomatic carotid artery disease, peripheral artery disease, abdominal aortic aneurysm, diabetes mellitus) and whose ten-year risk of developing CHD is < 10% ABI M X

N/A/ TBD 

### ○ Clinical Process/ Effective ness Preventive Cardiology Composite: Smoking Status and Cessation Support: Percentage of patients in the sample whose current smoking status is documented in the chart, and if they were smokers, were documented to have received smoking cessation counseling during the reporting period ABI M X

0060/ TBD 

### ○ Clinical Process/ Effective ness Hemoglobin A1c Test for Pediatric Patients: Percentage of pediatric patients 5-17 years of age with diabetes with a HbA1c test during the measurement period NCQ A X MU2

0108/ TBD 

### ○ Clinical Process/ Effective ness ADHD: Follow-Up Care for ChildrenPrescribed AttentionDeficit/Hyperactivity Disorder (ADHD) Medication: Percentage of children 6-12 years of age and newlydispensed a medication for attentiondeficit/hyperactivity disorder (ADHD) who had appropriate follow-up care. Two rates are reported. A. Percentage of children who had one follow-up visit with a practitioner with prescribing authority during the 30-Day Initiation Phase. B. Percentage of children who remained on ADHD medication for at least 210 days and who, in addition to the visit in the Initiation Phase, had at least two NCQ A X MU21034
additional follow-up visits with a practitioner within 270 days (9 months) after the Initiation Phase ended. 0110/ TBD 

### ○ Clinical Process/ Effective ness Bipolar Disorder and Major Depression: Appraisal for alcohol or chemical substance use: Percentage of patients with depression or bipolar disorder with evidence of an initial assessment that includes an appraisal for alcohol or chemical substance use Cente r for Qualit y Asses sment and Impro veme nt in Menta l Healt h X MU2

0403/ TBD 

### ○ Efficient Use of Healthcar e Resource s HIV/AIDS: Medical Visit: Percentage of patients, regardless of age, with a diagnosis of HIV/AIDS with at least two medical visits during the measurement year with a minimum of 60 days between each visit AMA /NCQ A X MU2

0608/ TBD 

### ○ Clinical Process/ Effective ness Pregnant women that had HBsAg testing: This measure identifies pregnant women who had a HBsAg (hepatitis B) test during their pregnancy Ingeni x X MU2

0710/ TBD 

### ○ Clinical Process/ Effective ness Depression Remission at Twelve Months: Adult patients age 18 and older with major depression or dysthymia and an initial PHQ-9 score > 9 who demonstrate remission at 12 months defined as PHQ-9 score less than 5. This measure applies to both patients with newly diagnosed and existing depression whose current PHQ-9 score indicates a need for treatment MNC M X MU2

0712/ TBD 

### ○ Clinical Process/ Effective ness Depression Utilization of the PHQ-9 Tool: Adult patients age 18 and older with the diagnosis of major depression or dysthymia who have a PHQ-9 tool administered at least once during a 4 month period in which there was a qualifying visit MNC M X MU2

1401/ TBD 

### ○ Populati on/Public Health Maternal depression screening: The percentage of children who turned 6 months of age during the measurement year, who had a face-to-face visit between the clinician and the child during child’s first 6 months, and who had a maternal depression screening for the mother at least once between 0 and 6 NCQ A X MU21035

months of life Not yet endor sed/ TBD 

### ○ Clinical Process/E ffectivene ss Hypertension: Improvement in blood pressure: Percentage of patients aged 18-85 years of age with a diagnosis of hypertension whose blood pressure improved during the measurement period CMS X MU2

Not yet endor sed/ TBD 

### ○ Care Coordinat ion Closing the referral loop: receipt of specialist report: Percentage of patients with referrals, regardless of age, for which the referring provider receives a report from the provider to whom the patient was referred CMS X MU2

Not yet endor sed/ TBD 

### ○ Patient and Family Engagem ent Functional status assessment for knee replacement: Percentage of patients aged 18 years and older with primary total knee arthroplasty (TKA) who completed baseline and follow-up (patient-reported) functional status assessments CMS X MU2

Not yet endor sed/ TBD 

### ○ Patient and Family Engagem ent Functional status assessment for hip replacement: Percentage of patients aged 18 years and older with primary total hip arthroplasty (THA) who completed baseline and follow-up (patient-reported) functional status assessments CMS X MU2

Not yet endor sed/ TBD 

### ○ Patient and Family Engagem ent Functional status assessment for complex chronic conditions: Percentage of patients aged 65 years and older with heart failure who completed initial and follow-up patient-reported functional status assessments CMS X MU2

TBD/ TBD 

### ○ Clinical Process/ Effective ness Children who have dental decay or cavities: Percentage of children ages 0- 20, who have had tooth decay or cavities during the measurement period Mater nal and Child Healt h Burea u, Healt h Resou rces and Servic es X MU2

TBD/ TBD 

### ○ Clinical Process/ Effective ness Primary Caries Prevention Intervention as Offered by Primary Care Providers, including Dentists: Percentage of children, age 0-20 years, Unive rsity of Minn X MU21036

who received a fluoride varnish application during the measurement period esota

TBD/ TBD 

### ○ Patient Safety ADE Prevention and Monitoring: Warfarin Time in Therapeutic Range: Average percentage of time in which individuals with atrial fibrillation who are on chronic anticoagulation have International Normalized Ratio (INR) test results within the therapeutic range during the measurement period CMS X MU2

* MU1 refers to CQMs included in the EHR Incentive Program – Stage 1 Final Rule for reporting in 2011-2013. MU2 refers to CQMs included in the EHR Incentive Program – Stage 2 Final Rule for reporting beginning in 2014
(3) PQRS Quality Measures Available for Gr oup Practices Using the GPRO Web interface We have previously discussed our measure proposals for group practices using the GPRO web interface in the proposed rule (77 FR 44954). A summary of these proposed measures for group practices using the GPRO web interface can be found in Table 35 of the CY 2013 PFS proposed rule (77 FR 44960). We proposed (77 FR 44959) 18 measures – including 2 composite measures for diabetes (5 component measures) a nd CAD (2 component meas ures), for a total of 22 measures – for reporting under the PQRS using the GPRO web interface for 2013 and beyond to align with the quality measures ava ilable for reporting under the Medicare Shared Savings Program (76 FR 67890). Because of our de sire to align with measures available for reporting under the Medicare Shared Savings Pr ogram, we did not propose to retain the 13 measures specified in Table 36 of the CY 2013 PFS proposed rule for purpose of reporting via the GPRO web interface beginning in 2013 (77 FR 44963). We invited public comment on the proposed PQRS quality measures available for reporting under the GPRO web interface for 2013 and beyond. We did not receive public comment on a majority of the measures we proposed for reporting in the GPRO web interface. The fo llowing is a summary of the comments we did receive regarding the proposed meas ures for the GPRO web interface:
Comment : Several commenters supported our over all proposal to align the measures1037 available for reporting in the GPRO web interfac e with the measures that are available for reporting under the Medicare Shared Savings Program. Response : We appreciate the commenters’ supp ort and are moving forward with our proposals to align the measures available for reporting in the GPRO web interface with the measures that are available for reporting under the Medi care Shared Savings Program. Therefore, mainly due to our desire to align measures available under PQRS and the Medicare Shared Savings Program, as indicated in Table 96 of this final rule, we are fina lizing the 18 measures – which includes 2 composites, for a total of 22 measures --- we proposed to be available for reporting via the GPRO web interface and not re taining 13 measures th at were previously available for reporting under the GPRO web interface in 2012. We also proposed to have the following measure available for reporting occurring in 2013 and beyond: CG-CAHPS Clinician/Group Survey: Getting timely care, appointments and information; How well your doctors communicat e; Patients rating of doctor; Access to specialists; Health promotion and education; Shared decision making; Courteous and helpful office staff; Care coordination; Between vi sit communication; Educating patients about medication adherences; and Stewardship of patient resources (77 FR 44964).
Comment : One commenter noted that the propo sed CAHPS measures do not apply to hospital-based physicians and encouraged PQRS to incorporate measures that reflect care provided by all types of physicians. Response : We believe that PQRS m easures should be broadly applicable to eligible professionals of varying practices. Therefore, we are not excluding hos pital-based physicians from reporting the CAHPS measures, as we believ e these CAHPS measures may be relevant to the practice of hospital-based physicians.
Comment : One commenter requested that our pr oposal to report the CG-CAHPS survey1038 measure under the GPRO web interface be made voluntary as the survey is expensive to administer. Response : We understand the commenter's co ncern regarding the expense of administering the CG-CAHPS survey. However, we require group prac tices using the GPRO web interface to report on all measures available under the GPRO web interface. As this CGCAHPS survey is part of the GPRO web interfac e, it will be mandatory for group practices using the GPRO web interface to also be held accountable for the survey results. We are developing a process, however, to standardize the administra tion of the survey, which should help lower the cost. We note that this survey measure requires a different form of data collection and analysis than the other proposed measures in the PQRS . Therefore, for these measures only, CMS intends to administer the survey on behalf of the group practices participating in the 2013 and 2014 PQRS GPRO. In other words, CMS initially intends to fund data collection for this measure on group practices’ behalf fo r the CYs 2013 and 2014 reporting periods. The final measures available for reporti ng using the GPRO web interface beginning in 2013 and listed in Table 96:

Table 96: PQRS Quality Measures Available fo r Reporting for Group Practices Using the GPRO Web Interface for 2013 and BeyondNQF/PQRS GPRO Disease Module National Quality Strategy Domain Measure and Title Description ¥Measure StewardOther QualityReportingPrograms

0059/ 1 Diabetes Mellitus Clinical Process/ Effectiven ess Diabetes: Hemoglobin A1c Poor Control: Percentage of patients aged 18 through75 years of age with diabetes mellitus who had most recent hemoglobin A1c greater than 9.0% NCQA HITECH ACO

0083/ 8 Heart Failure Clinical Process/ Effectiven Heart Failure (HF): Beta-Blocker Therapy for Left Ventricular Systolic Dysfunction (LVSD): Percentage of patients aged 18 years AMAPCPI/ ACCF HITECH ACO1039
ess and older with a diagnosis of heart failure (HF) with a current or prior left ventricular ejection fraction (LVEF) < 40% who were prescribed beta-blocker therapy either within a 12 month period when seen in the outpatient setting OR at each hospital discharge /AHA

0097/ 46 Care Coordin ation/ Patient Safety Patient Safety Medication Reconciliation: Percentage of patients aged 65 years and older discharged from any inpatient facility (e.g. hospital, skilled nursing facilit y, or rehabilitation facility) and seen within 60 days following discharge in the office by the physician providing on-going care who had a reconciliation of the discharge medications with the current medication list in the outpatient medical record documented AMAPCPI/ NCQA ACO

0041/ 110 Preventi ve Care Population /Public Health Preventive Care and Screening: Influenza Immunization: Percentage of patients aged 6 months and older seen for a visit between October 1 and March 31 who received an influenza immunization OR who reported previous receipt of an influenza immunization AMAPCPI HITECH ACO

0043/ 111 Preventi ve Care Clinical Process/ Effectiven ess Pneumococcal Vaccination Status for Older Adults: Percentage of patients aged 65 years and older who have ever received a pneumococcal vaccine NCQA HITECH ACO

0031/ 112 Preventi ve Care Clinical Process/ Effectiven ess Preventive Care and Screening: Breast Cancer Screening: Percentage of women aged 40 through69 years who had a mammogram to screen for breast cancer within 24 months NCQA HITECH ACO

0034/ 113 Preventi ve Care Clinical Process/ Effectiven ess Colorectal Cancer Screening: Percentage of patients aged 50 through75 years who received the appropriate colorectal cancer screening NCQA HITECH ACO

0066/ 118 Coronar y Artery Disease Clinical Process/ Effectiven ess Coronary Artery Disease (CAD): Angiotensin-converting Enzyme (ACE) Inhibitor or Angiotensin Receptor Blocker (ARB) Therapy -- Diabetes or Left Ventricular Systolic Dysfunction (LVEF < 40%): Percentage of patients aged 18 years and older with a diagnosis of coronary artery disease seen within a 12 month period who also have diabetes OR a current or prior Left Ventricular Ejection Fr action (LVEF) < 40% who were prescribed ACE inhibitor or ARB therapy AMAPCPI/ ACCF /AHA ACO

0421/ 128 Preventi ve Care Population /Public Adult Weight Screening and Follow-Up: Percentage of patients aged 18 years and older CMS/ QIP HITECH ACO1040

Health with a calculated body mass index (BMI) in the past 6 months or during the current visit documented in the medical record AND if the most recent BMI is outside of normal parameters , a follow-up plan is documented within the past 6 months or during the current visit Normal Parameters : Age 65 years and older BMI ≥ 23 and < 30; Age 18-64 years BMI ≥ 18.5 and < 25 0418/ 134 Preventi ve Care Population /Public Health Preventive Care and Screening: Screening for Clinical Depression: Percentage of patients aged 12 years and older screened for clinical depression on th e date of encounter using an age appropr iate standardized depression screening tool AND, if positive, a follow-up plan documented on the date of the positive screen CMS/ QIP HITECH ACO

0074/ 197 Coronar y Artery Disease Clinical Process/ Effectiven ess Coronary Artery Disease (CAD): Lipid Control: Percentage of patients aged 18 years and older with a diagnosis of coronary artery disease seen within a 12 month period who have a LDL-C result < 100 mg/dL OR patients who have a LDL-C result ≥ 100 mg/dL and have a documented plan of care to achieve LDL-C < 100mg/dL, including at a minimum the prescription of a statin AMAPCPI/ ACCF /AHA ACO

0068/ 204 Ischemi c Vascular Disease Clinical Process/ Effectiven ess Ischemic Vascular Disease (IVD): Use of Aspirin or Another Antithrombotic: Percentage of patients 18 years of age and older with Ischemic Vascular Disease (IVD) with documented use of aspirin or another antithrombotic NCQA HITECH ACO Million Hearts

0028/ 226 Preventi ve Care Population /Public Health Preventive Care and Screening: Tobacco Use: Screening and Cessation Intervention: Percentage of patients 18 years and older who were screened for tobacco use one or more times within 24 months AND who received cessation counseling intervention if identified as a tobacco user AMAPCPI HITECH ACO Million Hearts

0018/ 236 Hyperte nsion Clinical Process/ Effectiven ess Hypertension (HTN): Controlling High Blood Pressure: Percentage of patients aged18 through85 years of age who had a diagnosis of hypertension (HTN) and whose blood pressure was adequately controlled (< 140/90 mmHg) NCQA HITECH ACO Million Hearts

0075/ 241 Ischemi c Clinical Process/ Ischemic Vascular Disease (IVD): Complete Lipid Panel and LDL Control: Percentage of NCQA HITECH ACO1041

Vascular Disease Effectiven ess patients aged 18 years and older with Ischemic Vascular Disease (IVD) who received at least one lipid profile within 12 months and whose most recent LDL-C level was in control (less than 100 mg/dL) Million Hearts

N/A/ 317 Preventi ve Care Population /Public Health Preventive Care and Screening: Screening for High Blood Pressure and Follow-Up Documented: Percentage of patients aged 18 years and older seen during the measurement period who were screened for high blood pressure (BP) AND a recommended follow-up plan is documented based on the current blood pressure reading as indicated CMS/ QIP HITECH ACO Million Hearts

0101/ 318 Care Coordin ation/ Patient Safety Patient Safety Falls: Screening for Fall Risk: Percentage of patients aged 65 years and older who were screened for future fall risk at least once within the reporting period AMAPCPI/ NCQA HITECH ACO

0729/ TBD Diabetes Mellitus Clinical Process/ Effectiven ess Diabetes Composite: Optimal Diabetes Care: Patients ages 18 through 75 with a diagnosis of diabetes , who meet all the numerator targets of this composite measure:

• A1c < 8.0%

• LDL < 100 mg/dL

• blood pressure < 140/90 mmHg

• tobacco non-user

• (for patients with a diagnosis of ischemic vascular disease) daily aspirin use unless contraindicated MN Comm unity Measu rement ACO

(4) PQRS Measures Groups Available for Reporting for 2013 and Beyond We proposed the following 20 measures groups for reporting in the PQRS beginning with reporting periods occurring in 2013: Diabetes Mellitus; Chronic Kidney Disease (CKD); Preventive Care; Coronary Artery Bypass Graft (CABG); Rheumato id Arthritis (RA); Perioperative Care; Back Pain; Hepatitis C; Hear t Failure (HF); Coronary Artery Disease (CAD); Ischemic Vascular Disease (IVD); HIV/AIDS; As thma; Chronic Obstructive Pulmonary Disease (COPD); Inflammatory Bowel Disease (IBD); Sl eep Apnea; Dementia; Parkinson’s Disease; Hypertension; Cardiovascular Prevention; and Cataracts (77 FR 44964). These 20 proposed measures groups are also available fo r reporting under the PQRS in 2012.1042 Beginning in 2013, we proposed the oncology measures group for reporting under the PQRS that provides measures available for repor ting related to breast can cer and colon cancer. We believe it is important to measure cancer care (77 FR 44964). We proposed the following 4 measures groups for inclusion in the PQRS beginning with reporting periods occurring in 2014: Osteoporos is; Total Knee Replacement; Radiation Dose; and Preventive Cardiology. These measures groups address conditions that the measures groups established in 2012 do not address. Therefore, we proposed to finalize a total of 26 measures groups for inclusion in PQRS. We invited public comment on these proposed PQRS measures groups. The following is a summary of the comments we received regarding these proposed measures groups:
Comment : One commenter supported inclusion of the Cataracts measures group for 2013 and beyond, as the measures included in the measur es group are relevant to an ophthalmologist’s practice. Response : Based on the comment we received and for the reasons stated previously, we are finalizing the Cataracts measures group for 2013 and beyond.
Comment : One commenter generally supported the proposed osteoporosis measures group. However, the commenter suggests a change in the composition of the measures group. Specifically, the commenter suggested that CMS remove the proposed ABIM-sourced osteoporosis measures from the proposed osteop orosis measures group and, instead, include all six individual osteoporosis measures (P QRS measure numbers 24, 39, 40, 41, 154, and 155) currently available for reporting under PQRS. The commenter beli eves these six measures more closely reflect the desired outcomes to im prove osteoporosis disease prevention and management. Response : We appreciate the commenters’ feed back. However, we note that the1043 measures within the osteoporosis measures group ha ve been examined to determine the ability to report and analyze the measures contained within the measures group as a whole, whereas the suggested PQRS measures have not been analyzed to determine the feasibili ty of reporting these measures together within a measures group. Th erefore, we are finali zing the osteoporosis measures group as proposed.
Comment : One commenter supported the addition of a new Oncology measures group for 2013 and beyond. Response : Based on the comments received, we ar e finalizing the Oncology measures group for 2013 and beyond as proposed.
Comment : One commenter opposed the measures c ontained within the proposed Diabetes Mellitus measures group because the measures ar e not reflective of the highly-skilled, labor intensive cognitive care provided by an endocrinol ogist over a long period of time to treat patients with uncontrolled diabetes. The comment er also believed that use of the measures contained in the Diabetes Mellitus measures group provides an incentive for primary care physicians to cherry pick diabetes patients who have well-controlled di abetes and to request endocrinologic care for difficu lt and complicated patients. Response : We appreciate the commenter's feedb ack regarding the measures contained within the Diabetes Mellitus measures group. Wh ile we understand that the measures contained within the Diabetes Mellitus measures group do not address every aspect of care to those patients with diabetes, we believe that the measures co llect appropriate data a nd address an important issue. Therefore, we are finalizing the Diab etes Mellitus measures group with all of the proposed component measures for 2013 and be yond. However, we welcome other suggested measures addressing care of diabetes patients in the future. In addition, in 2012, the PQRS included a community-acquired pneumonia (CAP)1044 measures group among others. We did not propose to include this measur es group again in the PQRS measure set for th e 2013 PQRS or subsequent years because measures contained within this measures group were not recommended for retention by the Measure Applications Partnership. We received no comme nts regarding our decision not to continue inclusion this measures group for reporting in PQRS beginning in 2013. We also proposed, as identified in Table 47 of the CY 2013 PFS propos ed rule, to change the composition of the Coronary Artery Disease (CAD) measures group from what was finalized for 2012 (77 FR 44970). Specifically, we proposed to remove PQRS measure #196: Coronary Artery Disease (CAD): Symptom and Activity Asse ssment and replace this measure with PQRS measure #242: Coronary Artery Disease (CAD): Symptom Management in the CAD measures group, because the measure #196 was not recommended for retention by the Measure Applications Partnership (77 FR 44964). On the other hand, measure #242 was recommended for retention by the Measure Applications Partne rship. We received no comments regarding our proposal to change the compositi on of the CAD measures group. Therefore, we are finalizing the CAD measures group, as proposed. Based on the comments received and for the re asons previously state d, we are finalizing the following 26 measures groups indicated in Tables 97 through 122. Descriptions of the measures within each measures group are provid ed in Tables 97 through 122. Please note that some of the proposed measures included within a final PQRS quality measures group may also be available for reporting as an individual measure. In addition, please note that the Osteoporosis and Preventive Cardiology measures groups contain composite measures. Since composite measures must be reported as a group, similar to reporti ng measures within a measures group, we felt it was appropriate to classi fy these two composite measures as measures
groups.1045
TABLE 97: Diabetes Mellitus Measures Group* NQF/ PQRS Measure Title and Description Measure Developer 0059/ 1 Diabetes Mellitus: Hemoglobin A1c Po or Control in Diabetes Mellitus: Percentage of patients aged 18 through 75 years with diab etes mellitus who had most recent hemoglobin A1c greater than 9.0 percent NCQA

0064/ 2 Diabetes Mellitus: Low Density Lipoprotei n (LDL-C) Control in Diabetes Mellitus: Percentage of patients aged 18 through 75 y ears with diabetes melli tus who had most recent LDL-C level in control (less than 100 mg/dL) NCQA

0061/ 3 Diabetes Mellitus: High Blood Pressu re Control in Diabetes Mellitus: Percentage of patients aged 18 through 75 y ears with diabetes mellitus who had most recent blood pressure in control (less than 140/90 mmHg) NCQA

0055/ 117 Diabetes Mellitus: Dilated Eye Exam in Diabetic Patient: Percentage of patients aged 18 through 75 years with a diagnosis of diabetes mellitus who had a dilated eye exam NCQA 0062/ 119 Diabetes Mellitus: Urine Screening: Percentage of patients aged 18 through 75 years with diabetes (type 1 or type 2) who had a nephropathy screening test or evidence of nephropathy NCQA 0056/ 163 Diabetes Mellitus: Foot Exam: The percentage of patients aged 18 through 75 years with diabetes who had a foot examination NCQA *This measures group is reportable through both claims and registry-based reporting.. This measures group is available for reporting beginning in 2013. TABLE 98: Chronic Kidney Disease (CKD) Measures Group* NQF/ PQRS Measure Title and Description Measure Developer 0041/ 110 Preventive Care and Screening: Influenza Immunization: Percentage of patients aged 6 months and older who received an infl uenza immunization dur ing the flu season (October 1 through March 31) AMAPCPI AQA adopted/1 21 Adult Kidney Disease: Labora tory Testing (Lipid Profile): Percentage of patients aged 18 years and older with a diagnosis of CKD (stage 3, 4, or 5, not receiving Renal Replacement Therapy [RRT]) who had a fasti ng lipid profile performed at least once within a 12-month period AMAPCPI

AQA adopted/1 22 Adult Kidney Disease: Bl ood Pressure Management: Percentage of patient visits for those patients aged 18 years and older with a diagnosis of CKD (stage 3, 4, or 5, not receiving Renal Replacement Th erapy [RRT]) and documented proteinuria with a blood pressure < 130/80 mmHg OR ≥ 130/80 mmHg with a documented plan of care AMAPCPI

AQA adopted/1 23 Adult Kidney Disease: Patients On Er ythropoiesis-Stimulating Agent (ESA) - Hemoglobin Level > 12.0 g/dL: Percentage of calendar months within a 12-month period during which a Hemoglobin level is measured for patients aged 18 years and older with a diagnosis of advanced Chronic Kidney Disease (CKD) (stage 4 or 5, not receiving Renal Replacement Therapy [RRT]) or End Stage Renal Disease (ESRD) (who are on hemodialysis or peritoneal dialysis) who are also receiving ESA therapy AND have a Hemoglobin level > 12.0 g/dL AMAPCPI

*This measures group is reportable through both claims and registry-based reporting This measures group is available for reporting beginning in 2013. TABLE 99: Preventive Care Measures Group* NQF/ PQRS Measure Title and Description Measure Developer 0046/ 39 Screening or Therapy for Osteoporosis for Women Aged 65 Years and Older:Percentage of female patients aged 65 years and older who have a central dual-energy Xray absorptiometry (DXA) measur ement ordered or performed at least once since age 60 or pharmacologic therapy prescribed within 12 months AMAPCPI/ NCQA 0098/ 48 Urinary Incontinence: Assessment of Presence or Absence of Urinary Incontinence in Women Aged 65 Years and Older: Percentage of female patients aged 65 years and older who were assessed for the presence or absence of urinary incontinence within 12 AMAPCPI/ NCQA1046

NQF/ PQRS Measure Title and Description Measure Developer months 0041/ 110 Preventive Care and Screening: Influenza Immunization: Percentage of patients aged 6 months and older who received an infl uenza immunization dur ing the flu season (October 1 through March 31) AMAPCPI 0043/ 111 Preventive Care and Screening : Pneumonia Vaccination fo r Patients 65 Years and Older: Percentage of patients aged 65 years and older who have ever received a pneumococcal vaccine NCQA

0031/ 112 Preventive Care and Screeni ng: Screening Mammography: Percentage of women aged 40 through 69 years who had a ma mmogram to screen for breast cancer NCQA 0034/ 113 Preventive Care and Screening: Colorectal Cancer Screening: Percentage of patients aged 50 through 75 years who received th e appropriate colorectal cancer screening NCQA 0421/ 128 Preventive Care and Screening: Body Ma ss Index (BMI) Screening and Follow-Up: Percentage of patients aged 18 years and older with a calculated BMI in the past 6 months or during the current visit documented in th e medical record AND if the most recent BMI is outside of normal parameters, a follow-up plan is documented. Normal Parameters: Age 65 years and older BMI > 23and < 30; Age 18 – 64 years BMI > 18.5 and < 25. CMS/ QIP

AQA adopted/1 73 Preventive Care and Screening: Un healthy Alcohol Use – Screening: Percentage of patients aged 18 years and older who were screened for unhealthy alcohol use using a systematic screening method within 24 months AMAPCPI 0028/ 226 Preventive Care and Screening: Tobacco Us e: Screening and Cessation Intervention: Percentage of patients aged 18 years and older who were screened for tobacco use one or more times within 24 months AND who received cessation counseling intervention if identified as a tobacco user AMAPCPI

*This measures group is reportable through both claims and registry-based reporting This measures group is available for reporting beginning in 2013. TABLE 100: Coronary Artery Bypass Graft (CABG) Measures Group* NQF/ PQRS Measure Title and Description Measure Developer 0134/ 43 Coronary Artery Bypass Graft (CABG): Use of Internal Mammary Artery (IMA) in Patients with Isolated CABG: Surgery Percentage of patients aged 18 years and older undergoing isolated CABG surgery using an IMA graft STS

0236/ 44 Coronary Artery Bypass Graft (CABG): Preoperative Beta-Blocker in Patients with Isolated CABG Surgery: Percentage of patients aged 18 years and older undergoing isolated CABG surgery who received a beta-blo cker within 24 hours prior to surgical incision CMS/ QIP

0129/ 164 Coronary Artery Bypass Graft (CABG): Prolonged Intubation: Percentage of patients aged 18 years and older undergoing isolated CABG surgery who require intubation > 24 hours STS

0130/ 165 Coronary Artery Bypass Graft (CABG): Deep Sternal Wound Infection Rate: Percentage of patients aged 18 years and older undergoing isolated CABG surgery who, within 30 days postoperatively, develop deep sternal wound infection (involving muscle, bone, and/or mediastinum requiring operative intervention) STS

0131/ 166 Coronary Artery Bypass Graft (CABG): Stroke: Percentage of patients aged 18 years and older undergoing isolated CABG surgery who have a postoperative stroke (i.e., any confirmed neurological deficit of abrupt onset caused by a disturbance in blood supply to the brain) that did not resolve within 24 hours STS

0114/ 167 Coronary Artery Bypass Graft (CABG): Postoperative Renal Failure: Percentage of patients aged 18 years and older undergoing isolated CABG surgery (without pre-existing renal failure) who develop postoperativ e renal failure or require dialysis STS

0115/ 168 Coronary Artery Bypass Graft (CABG): Surgical Re-Exploration: Percentage of patients aged 18 years and older undergoing isolated CABG surgery who require a return to the operating room (OR) during the current hospitalization for mediastinal bleeding with or without tamponade, graft occlusion, valve dysfunction, or other cardiac reason STS1047

NQF/ PQRS Measure Title and Description Measure Developer 0116/ 169 Coronary Artery Bypass Graft (CABG): An tiplatelet Medications at Discharge: Percentage of patients aged 18 years and older undergoing isolated CABG surgery who were discharged on antiplatelet medication STS

0117/ 170 Coronary Artery Bypass Graft (CABG): Be ta-Blockers Administered at Discharge: Percentage of patients aged 18 years and older undergoing isolated CABG surgery who were discharged on beta-blockers STS

0118/ 171 Coronary Artery Bypass Graft (CABG): Anti-Lipid Treatment at Discharge: Percentage of patients aged 18 years and older undergoing isolated CABG surgery who were discharged on a statin or other lipid-lowering regimen STS

*This measures group is reportable through registry-based reporting only This measures group is available for reporting beginning in 2013. TABLE 101: Rheumatoid Arthritis (RA) Measures Group* NQF/ PQRS Measure Title and Description Measure Developer 0054/ 108 Rheumatoid Arthritis (RA): Disease Modifying Anti-Rheumatic Drug (DMARD) Therapy: Percentage of patients aged 18 years and older who were diagnosed with RA and were prescribed, dispensed, or administer ed at least one ambulatory prescription for a DMARD NCQA

AQA adopted/1 76 Rheumatoid Arthritis (RA) : Tuberculosis Screening: Percentage of patients aged 18 years and older with a diagnosis of RA who have documentation of a tuberculosis (TB) screening performed and results interpreted w ithin 6 months prior to receiving a first course of therapy using a biologic disease-modifying anti- rheumatic drug (DMARD) AMAPCPI/ NCQA AQA adopted/1 77 Rheumatoid Arthritis (RA): Periodic Assessment of Disease Activity: Percentage of patients aged 18 years and older with a diagnosis of RA who have an assessment and classification of disease activity within 12 months AMAPCPI/ NCQA AQA adopted /178 Rheumatoid Arthritis (RA): Functional Status Assessment: Percentage of patients aged 18 years and older with a diagnosis of RA for whom a functional status assessment was performed at least once within 12 months AMAPCPI/ NCQA AQA adopted/1 79 Rheumatoid Arthritis (RA): Assessment and Classification of Disease Prognosis: Percentage of patients aged 18 years and older with a diagnosis of RA who have an assessment and classification of disease pr ognosis at least once within 12 months AMAPCPI/ NCQA AQA adopted/1 80 Rheumatoid Arthritis (RA): Glucocorticoid Management: Percentage of patients aged 18 years and older with a diagnosis of RA who have been assessed for glucocorticoid use and, for those on prolonged doses of prednisone ≥ 10 mg daily (or equivalent) with improvement or no change in disease activity, documentation of glucocorticoid management plan within 12 months AMAPCPI/ NCQA

*This measures group is reportable through both claims and registry-based reporting TABLE 102: Perioperat ive Care Measures Group* NQF/ PQRS Measure Title and Description Measure Developer 0270/ 20 Perioperative Care: Timing of Antibiot ic Prophylaxis – Ordering Physician: Percentage of surgical patients aged 18 years and older undergoing procedures with the indications for prophylactic parenteral antibiotics, who have an order for prophylactic parenteral antibiotic to be given within one hour (if fluoroquinolone or vancomycin, 2 hours), prior to the surgical incision (or st art of procedure when no incision is required) AMAPCPI/ NCQA

0268/ 21 Perioperative Care: Selection of Prophylactic Antibiotic – First OR Second Generation Cephalosporin: Percentage of surgical patients aged 18 years and older undergoing procedures with the indications for a first OR second generation cephalosporin prophylactic antibiotic, who had an order for cefazolin OR cefuroxime for antimicrobial prophylaxis AMAPCPI/ NCQA 0271/ 22 Perioperative Care: Discontinuation of Prophylactic Antibiotics (Non-Cardiac Procedures): Percentage of non-cardiac surgical patients aged 18 years and older AMAPCPI/1048

NQF/ PQRS Measure Title and Description Measure Developer undergoing procedures with the indications for prophylactic parenteral antibiotics AND who received a prophylactic parenteral antibiotic , who have an order for discontinuation of prophylactic parenteral antibiotics within 24 hours of surgical end time NCQA

0239/ 23 Perioperative Care: Venous Thromboembolis m (VTE) Prophylaxis (When Indicated in ALL Patients): Percentage of patients aged 18 years and older undergoing procedures for which VTE prophylaxis is indicated in all patients, who had an order for Low Molecular Weight Heparin (LMWH), Low-Dose Unfractionated Heparin (LDUH), adjusted-dose warfarin, fondaparinux or mechanical prophylaxis to be given within 24 hours prior to incision time or within 24 hours after surgery end time AMAPCPI/ NCQA

*This measures group is reportable through both claims and registry-based reporting This measures group is available for reporting beginning in 2013. TABLE 103: Back Pain Measures Group* NQF/ PQRS Measure Title and Description Measure Developer 0322/ 148 Back Pain: Initial Visit: The percentage of patients aged 18 through 79 years with a diagnosis of back pain or undergoing back surgery who had back pain and function assessed during the initial visit to the clinician for the episode of back pain NCQA

0319/ 149/ Back Pain: Physical Exam: Percentage of patients aged 18 through 79 years with a diagnosis of back pain or undergoing back surgery who received a physical examination at the initial visit to the clinician for the episode of back pain NCQA

0314/ 150 Back Pain: Advice for Normal Activities: The percentage of patients aged 18 through 79 years with a diagnosis of back pain or undergoing back surgery who received advice for normal activities at the initial visit to the clinician for the episode of back pain NCQA

0313/ 151 Back Pain: Advice Against Bed Rest: The percentage of patients aged 18 through 79 years with a diagnosis of back pain or undergoing back surgery who received advice against bed rest lasting 4 days or longer at the initial visit to the clinician for the episode of back pain NCQA

*This measures group is reportable through both claims and registry-based reporting This measures group is available for reporting beginning in 2013. TABLE 104: Hepatitis C Measures Group* NQF/ PQRS Measure Title and Description Measure Developer 0395/ 84 Hepatitis C: Ribonucleic Acid (RNA) Testing Before Initia ting Treatment: Percentage of patients aged 18 years and older with a di agnosis of chronic hepatitis C who are receiving antiviral treatment for whom quantitative HCV RNA testing was performed within 6 months prior to initiation of antiviral treatment AMAPCPI

0396/ 85 Hepatitis C: HCV Genotype Testing Prior to Treatment: Percentage of patients aged 18 years and older with a diagnosi s of chronic hepatitis C who are receiving antiviral treatment for whom HCV genotype testing was performed prior to initiation of antiviral treatment AMAPCPI 0397/ 86 Hepatitis C: Antiviral Treatment Prescribed: Percentage of patients aged 18 years and older with a diagnosis of chronic hepatitis C who were prescribed at a minimum peginterferon and ribavirin therapy within the 12-month reporting period AMAPCPI 0398/ 87 Hepatitis C: HCV Ribonucleic Acid (RNA) Testing at Week 12 of Treatment: Percentage of patients aged 18 years and older with a diagnosis of chronic hepatitis C who are receiving antiviral treatme nt for whom quantitative HCV RN A testing was performed at no greater than 12 weeks from th e initiation of antiviral treatment AMAPCPI

0401/ 89 Hepatitis C: Counseling Regarding Risk of Alcohol Consumption: Percentage of patients aged 18 years and older with a diagnosis of hepatitis C who were counseled about the risks of alcohol use at least once within 12-months AMAPCPI 0394/ 90 Hepatitis C: Counseling Regar ding Use of Contraception Prior to Antiviral Therapy: Percentage of female patients aged 18 through 44 years and all men aged 18 years and older with a diagnosis of chronic hepatitis C who are receiving antiviral treatment who were AMAPCPI1049

NQF/ PQRS Measure Title and Description Measure Developer counseled regarding contraception prior to the initiation of treatment 0399/ 183 Hepatitis C: Hepatitis A Vaccina tion in Patients with HCV: Percentage of patients aged 18 years and older with a diag nosis of hepatitis C who received at least one injection of hepatitis A vaccine, or who have documented immunity to hepatitis A AMAPCPI 0400/ 184 Hepatitis C: Hepatitis B Vaccina tion in Patients with HCV: Percentage of patients aged 18 years and older with a diag nosis of hepatitis C who received at least one injection of hepatitis B vaccine, or who have documented immunity to hepatitis B AMAPCPI *This measures group is reportable through both claims and registry-based reporting This measures group is available for reporting beginning in 2013. TABLE 105: Heart Failu re (HF) Measures Group* NQF/ PQRS Measure Title and Description Measure Developer 0081/ 5 Heart Failure: Angiotensin-Converting Enzyme (ACE) Inhibitor or Angiotensin Receptor Blocker (ARB) Therapy for Left Ventricular Syst olic Dysfunction (LVSD): Percentage of patients aged 18 years and older with a diagnosis of heart failure and LVSD (LVEF < 40%) who were prescribed ACE inhibitor or ARB therapy AMAPCPI/ ACCF/AH A 0083/ 8 Heart Failure: Beta-Blocker Therapy for Left Ventricular Systolic Dysfunction (LVSD): Percentage of patients aged 18 years and older with a diagnosis of heart failure who also have LVSD (LVEF < 40%) and wh o were prescribed beta-blocker therapy AMAPCPI/ ACCF/AH A 0079/ 198 Heart Failure: Left Ventricular Ejection Fraction (LVEF) Assessment: Percentage of patients aged 18 years and older with a diagnosis of heart failure for whom the quantitative or qualitative result (of a recent or prior [any time in the past] LVEF assessment) is documented within a 12 month period AMAPCPI/ ACCF/AH A 0028/ 226 Preventive Care and Screening: Tobacco Us e: Screening and Cessation Intervention: Percentage of patients aged 18 years and older who were screened for tobacco use one or more times within 24 months AND who received cessation counseling intervention if identified as a tobacco user AMAPCPI

*This measures group is reportable through registry-based reporting only This measures group is available for reporting beginning in 2013. TABLE 106: Coronary Artery Disease (CAD) Measures Group* NQF/ PQRS Measure Title and Description Measure Developer 0067/ 6 Coronary Artery Disease (C AD): Antiplatelet Therapy: Percentage of patients aged 18 years and older with a diagnosis of coronary artery disease seen within a 12 month period who were prescribed aspirin or clopidogrel AMAPCPI/ ACCF/AH A 0074/ 197 Coronary Artery Disease (CAD): Lipid Control: Percentage of patients aged 18 years and older with a diagnosis of coronary artery disease seen within a 12 month period who have a LDL-C result < 100 mg/dL OR pa tients who have a LDL-C result ≥ 100 mg/dL and have a documented plan of care to achieve LDL-C <100 mg/dL, including at a minimum the prescription of a statin AMAPCPI/ ACCF/AH A 0028/ 226 Preventive Care and Screening: Tobacco Us e: Screening and Cessation Intervention: Percentage of patients aged 18 years and older who were screened for tobacco use one or more times within 24 months AND who received cessation counseling intervention if identified as a tobacco user AMAPCPI

N/A/ 242 Coronary Artery Disease (C AD): Symptom Management: Percentage of patients aged 18 years and older with a diagnosis of coronary artery disease seen within a 12-month period and with results of an evaluation of level of activity AND an assessment for the presence or absence of anginal symptoms, with a plan of care to manage anginal symptoms, if present AMAPCPI/ ACCF/ AHA *This measures group is reportable through registry-based reporting only1050

This measures group is available for reporting beginning in 2013. TABLE 107: Ischemic Vascular Disease (IVD) Measures Group* NQF/ PQRS Measure Title and Description Measure Developer 0073/ 201 Ischemic Vascular Disease (IVD): Blood Pressure Management Control: Percentage of patients aged 18 years and older with ischemic vascular disease (IVD) who had most recent blood pressure in control (less than 140/90 mmHg) NCQA

0068/ 204 Ischemic Vascular Disease (IVD): Use of Aspirin or Anoth er Antithrombotic: Percentage of patients aged 18 years and older with ischemic vascular disease (IVD) with documented use of aspirin or other antithrombotic NCQA

0028/ 226 Preventive Care and Screening: Tobacco Us e: Screening and Cessation Intervention: Percentage of patients aged 18 years and older who were screened for tobacco use one or more times within 24 months AND who received cessation counseling intervention if identified as a tobacco user AMAPCPI

0075/ 241 Ischemic Vascular Disease (IVD): Complete Lipid Panel and Low Density Lipoprotein (LDL-C) Control: Percentage of patients aged 18 years and older with Ischemic Vascular Disease (IVD) who received at least one lipid profile within 12 months and whose most recent LDL-C level was in cont rol (less than 100 mg/dL) NCQA

*This measures group is reportable through both claims and registry-based reporting This measures group is available for reporting beginning in 2013. TABLE 108: HIV/AIDS Measures Group* NQF/ PQRS Measure Title and Description Measure Developer 0404/ 159 HIV/AIDS: CD4+ Cell Count or CD4+ Percentage: Percentage of patients aged 6 months and older with a diagnosis of HIV/AIDS for whom a CD4+ cell count or CD4+ cell percentage was performed at least once every 6 months AMAPCPI/ NCQA 0405/ 160 HIV/AIDS: Pneumocystis Jiroveci Pneumonia (PCP) Prophylaxis: Percentage of patients aged 6 years and older with a diagnosis of HIV/AIDS and CD4+ cell count < 200 cells/mm3 who were prescribed PCP prophylaxi s within 3 months of low CD4+ cell count AMAPCPI/ NCQA 0406/ 161 HIV/AIDS: Adolescent and Adult Patients wi th HIV/AIDS Who Are Prescribed Potent Antiretroviral Therapy: Percentage of patients with a diagnosis of HIV/AIDS aged 13 years and older: who have a history of a nadir CD4+ cell count below 350/mm3 or who have a history of an AIDS- defining condition, regardless of CD4+ cell count; or who are pregnant, regardless of CD4+ cell count or age, who were prescribed potent antiretroviral therapy AMAPCPI/ NCQA

0407/ 162 HIV/AIDS: HIV RNA Control After Six Months of Potent Antiretroviral Therapy: Percentage of patients aged 13 years and older with a diagnosis of HIV/AIDS who are receiving potent antiretroviral therapy, who have a viral load below limits of quantification after at least 6 months of potent antiretroviral therapy or patients whose viral load is not below limits of quantification after at least 6 months of potent antiretroviral therapy and have documentation of a plan of care AMAPCPI/ NCQA

0409/ 205 HIV/AIDS: Sexually Transmitted Diseas e Screening for Chlamydia and Gonorrhea: Percentage of patients aged 13 years and older with a diagnosis of HIV/AIDS for whom chlamydia and gonorrhea screenings were performed at least once since the diagnosis of HIV infection AMAPCPI/ NCQA 0413/ 206 HIV/AIDS: Screening for High Risk Sexual Behaviors: Percentage of patients aged 13 years and older with a diagnosis of HIV/AIDS who were screened for high risk sexual behaviors at least once within 12 months AMAPCPI/ NCQA 0415/ 207 HIV/AIDS: Screening for Injection Drug Use: Percentage of patients aged 13 years and older with a diagnosis of HIV/AIDS who were sc reened for injection dr ug use at least once within 12 months AMAPCPI/ NCQA 0410/ 208 HIV/AIDS: Sexually Transmitte d Disease Screening for Syphilis: Percentage of patients aged 13 years and older with a diagnosis of HIV/AIDS who were screened for syphilis at AMAPCPI/1051

NQF/ PQRS Measure Title and Description Measure Developer least once within 12 months NCQA *This measures group is reportable through registry-based reporting only This measures group is available for reporting beginning in 2013. TABLE 109: Asthma Measures Group* NQF/ PQRS Measure Title and Description Measure Developer 0047/ 53 Asthma: Pharmacologic Therapy for Persistent Asthma: Percentage of patients aged 5 through 50 years with a diagnosis of mild, moderate, or severe persistent asthma who were prescribed either the preferred long-term cont rol medication (inhaled corticosteroid) or an acceptable alternative treatment AMAPCPI/ NCQA 0001/ 64 Asthma: Assessment of Asthma Control: Percentage of patients aged 5 through 50 years with a diagnosis of asthma who were evaluate d during at least one office visit within 12 months for the frequency (numeric) of daytime and nocturnal asthma symptoms AMAPCPI/ NCQA N/A/ 231 Asthma: Tobacco Use: Screening - Ambulatory Care Setting: Percentage of patients (or their primary caregiver) aged 5 through 50 years with a diagnosis of asthma who were queried about tobacco use and exposure to second hand smoke within their home environment at least once during the one-year measurement period AMAPCPI/ NCQA N/A/ 232 Asthma: Tobacco Use: Intervention - Ambulatory Care Setting: Percentage of patients (or their primary caregiver) aged 5 through 50 years with a diagnosis of asthma who were identified as tobacco users (p atients who currently use tobacco AND patients who do not currently use tobacco, but are exposed to second hand smoke in their home environment) who received tobacco cessation intervention at least once during the one-year measurement period AMAPCPI/ NCQA

*This measures group is reportable through both claims and registry-based reporting This measures group is available for reporting beginning in 2013. TABLE 110: Chronic Obstructive Pulmon ary Disease (COPD) Measures Group* NQF/ PQRS Measure Title and Description Measure Developer 0091/ 51 Chronic Obstructive Pulmonary Diseas e (COPD): Spirometry Evaluation: Percentage of patients aged 18 years and older with a diagnosis of COPD who had spirometry evaluation results documented AMAPCPI 0102/ 52 Chronic Obstructive Pulmonary Dise ase (COPD): Bronchodilator Therapy: Percentage of patients aged 18 years and older with a diagnosis of COPD and who have an FEV1/FVC less than 70 percent and have symptoms who were prescribed an inhaled bronchodilator AMAPCPI 0041/ 110 Preventive Care and Screening: Influenza Immunization: Percentage of patients aged 6 months and older who received an influenza immuniza tion during the flu season (October 1 through March 31) AMAPCPI 0043/ 111 Preventive Care and Screening : Pneumonia Vaccination fo r Patients 65 Years and Older: Percentage of patients aged 65 years and older who have ever received a pneumococcal vaccine NCQA

0028/ 226 Preventive Care and Screening: Tobacco Us e: Screening and Cessation Intervention: Percentage of patients aged 18 years and older who were screened for tobacco use one or more times within 24 months AND who received cessation counseling intervention if identified as a tobacco user AMAPCPI *This measures group is reportable through both claims and regist ry-based reporting This measures group is available for reporting beginning in 2013. TABLE 111: Inflammatory Bowe l Disease (IBD) Measures Group* NQF/ PQRS Measure Title and Description Measure Developer1052

NQF/ PQRS Measure Title and Description Measure Developer 0028/ 226 Preventive Care and Screening: Tobacco Us e: Screening and Cessation Intervention: Percentage of patients aged 18 years and older who were screened for tobacco use one or more times within 24 months AND who received cessation counseling intervention if identified as a tobacco user AMAPCPI

N/A/ 269 Inflammatory Bowel Disease (IBD): Type, Anatomic Location and Activity All Documented: Percentage of patients aged 18 years and older with a diagnosis of inflammatory bowel disease who have documented the disease type, anatomic location and activity, at least once during the reporting period AGA

N/A/ 270 Inflammatory Bowel Disease (IBD): Preventive Care: Corticosteroid Sparing Therapy: Percentage of patients aged 18 years and older with a diagnosis of inflammatory bowel disease who have been managed by corticosteroids greater than or equal to 10mg/day for 60 or greater consecutive days that have been prescribed corticos teroid sparing therapy in the last reporting year AGA

N/A/ 271 Inflammatory Bowel Disease (IBD): Preventive Care: Corticosteroid Related Iatrogenic Injury – Bone Loss Assessment: Percentage of patients aged 18 years and older with a diagnosis of inflammatory bowel diseas e who have received dose of corticosteroids greater than or equal to 10 mg/day for 60 or greater consecutive days and were assessed for risk of bone loss once per the reporting year AGA

N/A/ 272 Inflammatory Bowel Disease (IBD): Prev entive Care: Influenza Immunization: Percentage of patients aged 18 years and older with a diagnosis of inflammatory bowel disease for whom influenza immunization was recommended, administered or previously received during the reporting year AGA

N/A/ 273 Inflammatory Bowel Disease (IBD): Preven tive Care: Pneumococcal Immunization: Percentage of patients aged 18 years and older with a diagnosis of inflammatory bowel disease that had pneumococcal vaccination administered or previously received AGA

N/A/ 274 Inflammatory Bowel Disease (IBD): Test ing for Latent Tuberculosis (TB) Before Initiating Anti-TNF (Tumor Necrosis Factor) Therapy: Percentage of patients aged 18 years and older with a diagnosis of inflammatory bowel disease for whom a tuberculosis (TB) screening was performed and results interp reted within 6 months prior to receiving a first course of anti-TNF (tumor necrosis factor) therapy AGA

N/A/ 275 Inflammatory Bowel Disease (IBD): Assessment of Hepatitis B Virus (HBV) Status Before Initiating Anti-TNF (Tumor Necrosis Factor) Therapy: Percentage of patients aged 18 years and older with a diagnosis of inflammatory bowel disease who had Hepatitis B Virus (HBV) status assessed and results interp reted within one year prior to receiving a first course of anti-TNF (tumor necrosis factor) therapy AGA

*This measures group is reportable through registry-based reporting only This measures group is available for reporting beginning in 2013. TABLE 112: Sleep Apnea Measures Group* NQF/ PQRS Measure Title and Description Measure Developer N/A/ 276 Sleep Apnea: Assessment of Sleep Symptoms: Percentage of visits for patients aged 18 years and older with a diagnosis of obstructiv e sleep apnea that includes documentation of an assessment of symptoms, including pres ence or absence of snoring and daytime sleepiness AMAPCPI/ NCQA N/A/ 277 Sleep Apnea: Severity Assess ment at Initial Diagnosis: Percentage of patients aged 18 years and older with a diagnosis of obstru ctive sleep apnea who had an apnea hypopnea index (AHI) or a respiratory disturbance index (RDI) measured at the time of initial diagnosis AMAPCPI/ NCQA N/A/ 278 Sleep Apnea: Positive Airway Pressure Therapy Prescribed: Percentage of patients aged 18 years and older with a diagnosis of moderate or severe obstructive sleep apnea who were prescribed positive airway pressure therapy AMAPCPI/ NCQA N/A/ 279 Sleep Apnea: Assessment of Adherence to Positive Airway Pressure Therapy: Percentage of visits for patients aged 18 years and older with a diagnosis of obstructive AMAPCPI/1053

NQF/ PQRS Measure Title and Description Measure Developer sleep apnea who were prescribed pos itive airway pressure therapy who had documentation that adherence to positive ai rway pressure therapy was objectively measured NCQA

*This measures group is reportable through registry-based reporting only This measures group is available for reporting beginning in 2013. TABLE 113: Dementia Measures Group* NQF/ PQRS Measure Title and Description Measure Developer N/A / 280 Dementia: Stagin g of Dementia: Percentage of patients, regardless of age, with a diagnosis of dementia whose severity of dementia was classified as mild, moderate or severe at least once within a 12 month period AMA-PCPI

N/A / 281 Dementia: Cognitive Assessment: Percentage of patients, regardless of age, with a diagnosis of dementia for whom an assessment of cognition is performed and the results reviewed at least once within a 12 month period AMA-PCPI

N/A / 282 Dementia: Functional Status Assessment: Percentage of patients, regardless of age, with a diagnosis of dementia for whom an assessment of patient’s functional status is performed and the results reviewed at least once within a 12 month period AMA-PCPI

N/A / 283 Dementia: Neuropsychiatr ic Symptom Assessment: Percentage of patients, regardless of age, with a diagnosis of dementia and for whom an assessment of patient’s neuropsychiatric symptoms is performed and results reviewed at least once in a 12 month period AMA-PCPI

N/A / 284 Dementia: Management of Ne uropsychiatric Symptoms: Percentage of patients, regardless of age, with a diagnosis of dementia who have one or more neuropsychiatric symptoms who received or were recomm ended to receive an intervention for neuropsychiatric symptoms within a 12 month period AMA-PCPI

N/A / 285 Dementia: Screening for Depressive Symptoms: Percentage of patients, regardless of age, with a diagnosis of dementia who were screened for depressive symptoms within a 12 month period AMA-PCPI

N/A / 286 Dementia: Counseling Regarding Safety Concerns: Percentage of patients, regardless of age, with a diagnosis of dementia or th eir caregiver(s) who were counseled or referred for counseling regarding safety concerns within a 12 month period AMA-PCPI

N/A / 287 Dementia: Counseling Regardi ng Risks of Driving: Percentage of patients, regardless of age, with a diagnosis of dementia or th eir caregiver(s) who were counseled regarding the risks of driving and driving alternatives within a 12 month period AMA-PCPI

N/A / 288 Dementia: Caregiver Educ ation and Support: Percentage of patients, regardless of age, with a diagnosis of dementia whose caregiver(s) were provided with education on dementia disease management and health behavior changes AND referred to additional sources for support within a 12 month period AMA-PCPI

*This measures group is reportable thr ough claims and registry-based reporting This measures group is available for reporting beginning in 2013. TABLE 114: Parkinson’s Disease Measures Group* NQF/ PQRS Measure Title and Description Measure Developer N/A / 289 Parkinson’s Disease: Annual Park inson’s Disease Diagnosis Review: All patients with a diagnosis of Parkinson’s disease who had an annual assessment including a review of current medications (e.g., medications than can produce Parkinson- like signs or symptoms) and a review for the pr esence of atypical features (e .g., falls at presentation and early in the disease course, poor response to levodopa, symmetry at onset, rapid progression [to Hoehn and Yahr stage 3 in 3 years], lack of tremor or dysautonomia) at least annually AAN

N/A / Parkinson’s Disease: Psychiatric Diso rders or Disturbances Assessment: All patients AAN1054

NQF/ PQRS Measure Title and Description Measure Developer 290 with a diagnosis of Parkinson’s disease who were assessed for psychiatric disorders or disturbances (e.g., psychosis, depression, anxiety disorder, apathy, or impulse control disorder) at least annually N/A / 291 Parkinson’s Disease: Cognitive Impa irment or Dysfunction Assessment: All patients with a diagnosis of Parkinson’s disease wh o were assessed for cognitive impairment or dysfunction at least annually AAN

N/A / 292 Parkinson’s Disease: Querying about Sleep Disturbances: All patients with a diagnosis of Parkinson’s disease (or caregivers, as appropriate) who were queried about sleep disturbances at least annually AAN

N/A / 293 Parkinson’s Disease: Rehab ilitative Therapy Options: All patients with a diagnosis of Parkinson’s disease (or caregiver(s), as appr opriate) who had rehabilitative therapy options (e.g., physical, occupational, or speech therapy) discussed at least annually AAN

N/A / 294 Parkinson’s Disease: Parkinson’s Disease Medical and Surgical Treatment Options Reviewed: All patients with a diagnosis of Park inson’s disease (or caregiver(s), as appropriate who had the Parkinson’s disease treatment options (e.g., non-pharmacological treatment, pharmacological tr eatment, or surgical treatment) reviewed at least once annually AAN

*This measures group is reportable through registry-based reporting only This measures group is available for reporting beginning in 2013. TABLE 115: Hypertension Measures Group* NQF/ PQRS Measure Title and Description Measure Developer N/A/ 295 Hypertension: Appropriate Us e of Aspirin or Other Anti platelet or Anticoagulant Therapy: Percentage of patients aged 15 through 90 years old with a diagnosis of hypertension who were prescribed aspirin or other anticoagulant/antiplatelet therapy ABIM

N/A/ 296 Hypertension: Complete Lipid Profile: Percentage of patients aged 15 through 90 years old with a diagnosis of hypertension who re ceived a complete lipid profile within 24 months ABIM

N/A/ 297 Hypertension: Urine Protein Test: Percentage of patients aged 15 through 90 years old with a diagnosis of hypertension who either have chronic kidney disease diagnosis documented or had a urine protein test done within 36 months ABIM

N/A/ 298 Hypertension: Annual Serum Creatinine Test: Percentage of patients aged 15 through 90 years old with a diagnosis of hypertension who had a serum creatinine test done within 12 months ABIM

N/A/ 299 Hypertension: Diabetes Mellitus Screening Test: Percentage of patients aged 15 through 90 years old with a diagnosis of hypertension who had a diabetes screening test within 36 months ABIM

N/A/ 300 Hypertension: Blood Pressure Control: Percentage of patients aged 15 through 90 years old with a diagnosis of hypertension who had most recent blood pressure level under control (at goal) ABIM

N/A/ 301 Hypertension: Low Density Li poprotein (LDL-C) Control: Percentage of patients aged 15 through 90 years old with a diagnosis of hypertension who had most recent LDL cholesterol level under control (at goal) ABIM

N/A/ 302 Hypertension: Dietary and Physical Activity Modifications Appropriately Prescribed: Percentage of patients aged 15 through 90 years old with a diagnosis of hypertension who received dietary and physical activity counseling at least once within 12 months ABIM

*This measures group is reportable through registry-based reporting only This measures group is available for reporting beginning in 2013. TABLE 116: Cardiovascular Prevention Measures Group* NQF/ PQRS Measure Title and Description Measure Developer1055

NQF/ PQRS Measure Title and Description Measure Developer 0064/ 2 Diabetes Mellitus: Low Density Lipoprotei n (LDL-C) Control in Diabetes Mellitus: Percentage of patients aged 18 through 75 years with diabetes mellitus who had most recent LDL-C level in contro l (less than 100 mg/dL) NCQA

0068/ 204 Ischemic Vascular Disease (IVD): Use of Aspirin or Anoth er Antithrombotic: Percentage of patients aged 18 years and older with ischemic vascular disease (IVD) with documented use of aspirin or other antithrombotic NCQA

0028/ 226 Preventive Care and Screening: Tobacco Us e: Screening and Cessation Intervention: Percentage of patients aged 18 years and older who were screened for tobacco use one or more times within 24 months AND who received cessation counseling intervention if identified as a tobacco user AMAPCPI

0018/ 236 Hypertension (HTN): Controlling High Blood Pressure: Percentage of patients aged 18 through 85 years of age who had a diagnosis of hypertension (HTN) and whose BP was adequately controlled (< 140/90 mmHg) NCQA

0075/ 241 Ischemic Vascular Disease (IVD): Co mplete Lipid Panel and Low Density Lipoprotein (LDL-C) Control: Percentage of patients aged 18 years and older with Ischemic Vascular Disease (IVD) who received at least one lipid profile within 12 months and whose most recent LDL-C level was in control (less than 100 mg/dL) NCQA

N/A/ 317 Preventive Care and Screening: S creening for High Blood Pressure: Percentage of patients aged 18 and older who are screened for high blood pressure CMS/ QIP *This measures group is reportable through both claims and registry-based reporting This measures group is available for reporting beginning in 2013. TABLE 117: Cataracts Measures Group* NQF/ PQRS Measure Title and Description Measure Developer 0565/ 191 Cataracts: 20/40 or Better Visual Acuity within 90 Days Following Cataract Surgery: Percentage of patients aged 18 years and olde r with a diagnosis of uncomplicated cataract who had cataract surgery and no significant ocular conditions impacting the visual outcome of surgery and had best-corrected visual acuity of 20/40 or better (distance or near) achieved within 90 days following the cataract surgery AMAPCPI/ NCQA

0564/ 192 Cataracts: Complications within 30 Days Following Cataract Surgery Requiring Additional Surgic al Procedures: Percentage of patients aged 18 years and older with a diagnosis of uncomplicated cataract who had cataract surgery and had any of a specified list of surgical procedures in the 30 days following cataract surger y which would indicate the occurrence of any of the following major complications: retained nuclear fragments, endophthalmitis, dislocated or wrong power IOL, retinal detachment, or wound dehiscence AMAPCPI/ NCQA

N/A/ 303 Cataracts: Improvement in Pa tient’s Visual Fu nction within 90 Days Following Cataract Surgery: Percentage of patients aged 18 years and older in sample who had cataract surgery and had improvement in visual function achieved within 90 days following the cataract surgery, based on completing a pre-operative and post-operative visual function survey AAO

N/A/ 304 Cataracts: Patient Satisfaction within 90 Days Following Cataract Surgery: Percentage of patients aged 18 years and older in sample who had cataract surgery and were satisfied with their care within 90 days following the cataract surgery, based on completion of the Consumer Assessment of Healthcare Providers an d Systems Surgical Care Survey AAO

*This measures group is reportable through registry-based reporting only This measures group is available for reporting beginning in 2013. TABLE 118: Oncology Measures Group*1056NQF/PQRS Measure Title and DescriptionMeasureDeveloper

0387/ 71 Breast Cancer: Hormonal Thera py for Stage IC-IIIC Estrogen Receptor/Progesterone Receptor (ER/ PR) Positive Breast Cancer: Percentage of female patients aged 18 years and older with Stage IC through IIIC, ER or PR positive br east cancer who were prescribed tamoxifen or aromatase inhibitor (A I) during the 12-month reporting period AMAPCPI/ ASCO/ NCCN 0385/ 72 Colon Cancer: Chemotherapy for Stage III Colon Cancer Patients: Percentage of patients aged 18 years a nd older with Stage IIIA through IIIC colon cancer who are referred for adjuvant chemotherapy, prescribed adjuvant chemotherapy, or have previ ously received adjuvant chemotherapy within the 12-month reporting period AMAPCPI/ ASCO/ NCCN 0041/ 110 Preventive Care and Screening: Influenza Immunization: Percentage of patients aged 6 months and older who received an influenza immunization during the flu season (October 1 through March 31) AMAPCPI 0419/ 130 Documentation of Current Medicat ions in the Medical Record: Percentage of specified vi sits for patients aged 18 years and older for which the eligible professional attests to do cumenting a list of current medications to the best of his/her knowl edge and ability. This list must include ALL prescriptions, over-the-counters, herbals, vitamin/mineral/dietary (nutritional) supplements AND must contain the medications’ name, dosage, frequency and route CMS/ QIP

0384/ 143 Oncology: Medical and Radiation – Pain Intensity Quantified: Percentage of patient vis its, regardless of patient ag e, with a diagnosis of cancer currently receiving chemotherapy or radiation therapy in which pain intensity is quantified AMAPCPI

0383/ 144 Oncology: Medical and Radiation – Plan of Care for Pain: Percentage of patient visits, regardless of patient age, with a dia gnosis of cancer currently receiving chemotherapy or radiation therapy who repor t having pain with a documented plan of care to address pain AMAPCPI

0386/ 194 Oncology: Cancer Stage Documented: Percentage of patients, regardless of age, with a diagnosis of breast, colon, or rectal cancer who are seen in the ambulatory setting who have a baseline AJCC cancer stage or documentation that the cancer is metast atic in the medical record at least once within 12 months AMAPCPI/ ASCO

0028/ 226 Preventive Care and Screening: Toba cco Use: Screening and Cessation Intervention: Percentage of patients aged 18 years and older who were screened for tobacco use one or more times within 24 months AND who received cessation counseli ng intervention if identif ied as a tobacco user AMAPCPI

*This measures group is reportable through registry-based reporting only This measures group is available for reporting beginning in 2013. TABLE 119: Osteoporosis Measures Group* NQF/ PQRS Measure Title Measure Developer 0046/ Osteoporosis: Screening or Therapy for Osteoporosis for Women Aged 65 Years AMA1057

NQF/ PQRS Measure Title Measure Developer 39 and Older: Percentage of female patients aged 65 years and older who have a central dual-energy X-ray absorptiometry (DXA) meas urement ordered or performed at least once since age 60 or pharmacologic therapy prescribed within 12 months 0049/ 41 Osteoporosis: Pharmacologic Therapy for Men and Women Aged 50 Years and Older: Percentage of patients aged 50 years and older with a diagnosis of osteoporosis who were prescribed pharmacologic therapy within 12 months AMA

AQA Selected /154 Falls: Risk Assessment for Falls: Percentage of patients aged 65 years and older with a history of falls who had a risk assessment for falls completed within 12 months NCQA

AQA Selected /155 Falls: Plan of Care for Falls: Percentage of patients aged 65 years and older with a history of falls who had a plan of care for falls documented within 12 months NCQA

N/A / TBD Osteoporosis: Status of Participation in Weight-Bearing Exercise and Weightbearing Exercise Advice: Percentage of patients aged 18 and older with a diagnosis of osteoporosis, osteopenia, or prior low impact fracture; women age 65 and older; or men age 70 and older whose status regarding participation in weight-bearing exercise was documented and for those not participating regularly who received advice within 12 months to participate in weight-bearing exercise ABIM

N/A / TBD Osteoporosis: Current Level of Alcohol Us e and Advice on Pote ntially Hazardous Drinking Prevention: Percentage of patients aged 18 and older with a diagnosis of osteoporosis, osteopenia, or prior low impact fracture; women age 65 and older; or men age 70 and older whose current level of alcohol use was documented and for those engaging in potentially hazardous drinking who received counseling within 12 months ABIM

N/A / TBD Osteoporosis: Screen for Falls Risk Evalua tion and Complete Fa lls Risk Assessment and Plan of Care: Percentage of patients aged 18 and older with a diagnosis of osteoporosis, osteopenia, or prior low impact fracture; women age 65 and older; or men age 70 and older who had a screen for falls risk evaluation within the past 12 months and for those reported as having a history of two or more falls, or fall-related injury who had a complete risk assessment for falls and a falls plan of care within the past 12 months ABIM

N/A / TBD Osteoporosis: Dual-Emission X-ray Absorptiometry (DXA) Scan: Percentage of patients aged 18 and older with a diagnosis of osteoporosis, osteopenia, or prior low impact fracture; women age 65 and older; or men age 70 and older who had a DXA scan and result documented ABIM

N/A / TBD Osteoporosis: Calcium Intake Assessment and Counseling: Percentage of patients aged 18 and older with a diagnosis of osteoporosis, osteopenia, or prior low impact fracture; women age 65 and older; or men age 70 and older who had calcium intake assessment and counseling at least once within 12 months ABIM

N/A / TBD Osteoporosis: Vitamin D Intake Assessment and Counseling: Percentage of patients aged 18 and older with a diagnosis of osteoporosis, osteopenia, or prior low impact fracture; women age 65 and older; or men age 70 and older who had vitamin D intake assessment and counseling at least once within 12 months ABIM

N/A / TBD Osteoporosis: Pharmacologic Therapy: Percentage of patients aged 18 and older with a diagnosis of osteoporosis, osteopenia, or prior low impact fracture; women age 65 and older; or men age 70 and older who were prescribed pharmacologic therapy approved by the Food and Drug Administration ABIM

*This measures group is reportable through claims and registry-based reporting This measures group is available for reporting beginning in 2014. TABLE 120: Total Knee Replacement Measures Group* NQF/ PQRS Measure Title Measure Developer1058

NQF/ PQRS Measure Title Measure Developer N/A / TBD Total Knee Replacement: Coordina tion of Post Discharge Care: Percentage of patients undergoing total knee replacement who received written instructions for post discharge care including all the following: post discharge p hysical therapy, home health care, post discharge deep vein thrombosis (DVT) prophylaxis and follow-up physician visits AAHKS/A MA-PCPI

N/A / TBD Total Knee Replacement: Venous Thromb oembolic and Cardiovascular Risk Evaluation: Percentage of patients undergoing a total knee replacement who are evaluated for the presence or absence of venous thromboembolic and cardiovascular risk factors within 30 days prior to the procedure including history of deep vein thrombosis (DVT), pulmonary embolism (PE), myocardial infarction (MI), arrhythmia and stroke AAHKS/A MA-PCPI

N/A / TBD Total Knee Replacement: Preoperative Antibi otic Infusion with Proximal Tourniquet: Percentage of patients undergoing a tota l knee replacement who had the prophylactic antibiotic completely infused prior to the inflation of the proximal tourniquet AAHKS/A MA-PCPI

N/A / TBD Total Knee Replacement: Identification of Implanted Prosthesis in Operative Report: Percentage of patients undergoing total knee replacement whose operative report identifies the prosthetic implant specifications includ ing the prosthetic implant manufacturer, the brand name of prosthetic implant and the size of prosthetic implant AAHKS/A MA-PCPI

*This measures group is reportable through and registry-based only This measures group is available for reporting beginning in 2014. TABLE 121: Radiation Dose Optimization Measures Group* NQF/ PQRS Measure Title Measure Developer TBD/ TBD Radiation Dose Optimization: Utilization of a Standardized Nomenclature for CT Imaging Description: Percentage of computed tomography (CT) imaging reports for all patients, regardless of age, with the imaging study named according to a standardized nomenclature (e.g., RadLex®) and the standardized nomenclature is used in institutions computer systems AMAPCPI

TBD/ TBD Radiation Dose Optimization: Cumulative Count of Potential High Dose Radiation Imaging Studies: Computed Tomography (C T) Scans and Cardiac Nuclear Medicine Scans: Percentage of CT and cardiac nuclear medicine (myocardial perfusion) imaging reports for all patients, regardless of age, that document a count of known previous CT studies (any type of CT) and cardiac nuclear medicine (myocardial perfusion studies) studies that the patient has received in the 12-m onth period prior to the current study AMAPCPI

TBD/ TBD Radiation Dose Optimization: Reporting to a Radiation Dose Index Registry: Percentage of total computed tomography (CT) studies performed for all patients, regardless of age, that are reported to a radiation dose index registry AND that include at a minimum selected data elements AMAPCPI

TBD/ TBD Radiation Dose Optimization: Images Available for Patient Follow-up and Comparison Purposes: Percentage of final reports for imaging studies performed for all patients, regardless of age, which document that Digital Imaging and Communications in Medicine (DICOM) format image data are available reciprocally to non-affiliated external entities on a secure, media free, searchable basis with patient authorization for at least a 12- month period after the study AMAPCPI

TBD/ TBD Radiation Dose Optimization: Search for Prior Imaging Studie s Through a Secure, Authorized, Media-Free, Shared Archive: Percentage of final reports of imaging studies performed for all patients, regardless of ag e, which document that a search for Digital Imaging and Communications in Medicine (D ICOM) format images was conducted for prior patient imaging studies completed at non-affiliated external entities within the past 12- months and are available through a secure, auth orized, media free, shared archive prior to an imaging study being performed AMAPCPI

*This measures group is reportable through both claims and registry-based reporting This measures group is available for reporting beginning in 2014.1059

TABLE 122: Preventive Cardiology Measures Group* NQF/ PQRS Measure Title Measure Developer N/A/ TBD Preventive Cardiology Compos ite: Blood Pressure at Goal: Percentage of patients in the sample whose most recent blood pressure reading was at goal ABIM N/A/ TBD Preventive Cardiology Composite: Low De nsity Lipids (LDL) Cholesterol at Goal: Percentage of patients in the sample whose LD L cholesterol is considered to be at goal, based upon their coronary heart disease (CHD) risk factors ABIM

N/A/ TBD Preventive Cardiology Compos ite: Timing of Lipid Testin g Complies with Guidelines: Percentage of patients in the sample whose ti ming of lipid testing complies with guidelines (lipid testing performed in th e preceding 12-month period (with a 3-month grace period) for patients with known coronary heart disease (CHD) or CHD risk equivalent (prior myocardial infarction (MI), other clinical CHD, symptomatic carotid artery disease, peripheral artery disease, abdominal aortic aneu rysm, diabetes mellitus); or in the preceding 24-month period (with a 3-month grace period) for patients with > 2 risk factors for CHD (smoking, hypertension, low high density lipid (HDL), men > 45 years, women > 55 years, family history of premature CHD; HDL > 60 mg/dL acts as a negative risk factor); or in the preceding 60-month period (with a 3-m onth grace period) for patients with < 1 risk factor for CHD) ABIM

N/A/ TBD Preventive Cardiology Composite: Di abetes Documentation or Screen Test: Percentage of patients in the sample who had a screening test for type 2 diabetes or had a diagnosis of diabetes ABIM

N/A/ TBD Preventive Cardiology Composite: Correc t Determination of Ten-Year Risk for Coronary Death or Myocardial Infarction (MI): Number of patients in the sample whose ten-year risk of coronary death or MI is correctly assessed and documented ABIM

N/A/ TBD Preventive Cardiology Composite: Counseling for Diet and Physical Activity: Percentage of patients in the sample who received dietary and physical activity counseling ABIM N/A/ TBD Preventive Cardiology Composite: A ppropriate Use of Aspirin or Other Antiplatelet/Anticoagulant Therapy: Percentage of patients in the sample who are: 1) taking aspirin or other anticoagulant/antiplatelet therapy, or 2) under age 30, or 3) age 30 or older and who are documented to be at low risk. Low-risk patients include those who are documented with no prior coronary heart disease (CHD) or CHD risk equivalent (prior myocardial infarction (MI), other clinical CHD, symptomatic carotid artery disease, peripheral artery disease, abdominal aortic an eurysm, diabetes mellitus) and whose ten-year risk of developing CHD is < 10% ABIM

N/A/ TBD Preventive Cardiology Composite: Smoking Status and Cessation Support: Percentage of patients in the sample whose current smoking status is documented in the chart, and if they were smokers, were documented to have received smoking cessation counseling during the reporting period ABIM

*This measures group is reportable through both claims and registry-based reporting This measures group is available for reporting beginning in 2014. (5) Physician Quality Reporting System Measures for Eligible Professionals and Group Practices that Report Using Administrative Claims for the 2015 Payment Adjustment We proposed 19 measures – including 15 pro cess and 4 outcome measures derived from administrative claims – for eligible profe ssionals and group practi ces that report using administrative claims for the 2015 and 2016 payment adjustments (see Table 63 of the CY 2013 PFS proposed rule, 77 FR 44981). Our proposals on how to attribute benefi ciaries to groups of1060 physicians that elect the administ rative claims option were discu ssed in the value-based payment modifier in section III.K. of the proposed rule. We considered all of the 28 process measures included in the program year 2010 individual Physic ian Feedback reports th at can be calculated using administrative claims but pr oposed only a subset of the meas ures that were included in the program year 2010 individual Physician Feedback re ports. We proposed this subset of measures for both the PQRS payment adjustment and the va lue-based modifier beca use we believe these measures are clinically meani ngful, focus on highly prevalent conditions among beneficiaries, have the potential to differentiate physicians, and be statistically reli able (77 FR 44980). We also sought comment on whether to include any of the remaini ng 13 measures included in the program year 2010 individual Physician Feedback Reports (77 FR 44998) (see Table 65 of the CY 2013 PFS proposed rule, 77 FR 45000). The utilization of the ad ministrative claims measures will allow PQRS to implement differen t reporting options which capture a wider venue of participants without using the traditional methods of reporting. We invited public comment on these proposed measures. The following is a summary of the comments we received regarding the proposed measures for eligible professionals and group practices that report using th e administrative claims-based reporting mechanism for the 2015 and/or 2016 PQRS payment adjustments. Pleas e note that, since we are not finalizing an administrative claims-based reporting option for the 2016 PQRS payment adjustment, they will only be available for the purpose of repor ting for the 2015 PQRS payment adjustment.
Comment : Most commenters agreed with assess ing performance rates for the measures in the PQRS administrative claims-based reporting option at the TIN level. Response : We thank commenters for their support for this proposal and we are finalizing our proposal to calculate the Administrative Clai ms based measures at the single TIN level and applying the TIN’s performance to the TIN or to an individual NPI that elects the Administrative1061 Claims option at the individual level.
Comment : One commenter opposed assessing opht halmologists against the proposed administrative claims-based measures. The comm enter notes that only 1 proposed administrative claims-based measure is applicable to ophtha lmology. Although an ophthalmologist would be able to elect the administrati ve claims option and meet the measure targets based on the care their patients received from other physicians, th e commenter does not believe it is appropriate for CMS to attribute care of non-eye conditions by other physicians to the ophthalmologist. Response : We appreciate the commenter's fee dback and realize that the proposed administrative claims-based measures may not adequately assess the specific scope of care furnished by ophthalmologists or other specialists to their patients. However, we believe this reporting option promotes shared accountability and care coordination for the quality of care furnished to beneficiaries and therefore provides important a nd actionable information for physicians about their
beneficiaries. We also expect physicians and groups of physicians to report data on quality measures that reflect the care they furnish. We are therefore allowing ophthalmologists and other specialists to elect to be assessed against the administrative claims-based measures for purposes of the 2015 PQRS payment adjustment , both to provide ophthalmologists and other specialists with multiple options to meet the cr iteria for satisfactory reporting for the 2015 PQRS payment adjustment and to provide them with actionable information about shared accountability and care coordination important to their bene ficiaries. We note that establishing the administrative claims-based reporting option for eligible professionals does not preclude ophthalmologists and other specialists to particip ate in PQRS using other reporting mechanisms and reporting other PQRS measures. Process Quality Measures . Of the 19 measures we proposed for reporting under the administrative claims-based reporting mechanism, 15 of these proposed measures were process1062 measures. The following is a summary of the comments we received on these proposed process

measures. Comment : Most commenters supported the Admini strative Claims option and proposed process measures and saw it as a “low burde n method to avoid the PQRS and value-based payment modifier adjustment,” although ma ny expressed their dissatisfaction with administrative-claims-based measures in general, since these measures are derived from billing data and, as a result, lack the nuances of clinical data. Other commenters noted that the proposed measures were most applicable to the care of chronic conditions and preventive care and would not apply to the practice of ma ny specialists and subspecialists . Commenters recommended that CMS include only measures that are NQF endorsed and that they be endorsed at the physician and/or group practice level. Response : We thank the commenters for their sugge stions. As commenters stated, while administrative claims-based measures have shor tcomings for clinical process measurement due to their lack of clinical data, we have chosen to preferentially use claims-based process measures that have NQF endorsement and were found to have high reliability in the program year 2010 physician feedback reports. As we have stated above, by providing physicians with information about their beneficiaries outside of their specialty, we are prom oting shared accountability and care coordination for beneficiaries, which we believe are important domains promoted by the National Quality Strategy. We are finalizing 13 of the proposed 15 process measures and are adding NQF 0022, “Use of High Risk Medicines in the Elderly,” which we had used in the 2010 physician feedback reports. We agree with the comments that we should, where possible, use NQF-endorsed measures for this reporting option, but we do not believe that CMS should change or update measures that have b een endorsed. We believe updating measure specifications is the responsibility of the measure st eward. With that being sai d, we do plan to monitor NQF1063 endorsement activity and will adjust the measures in the Administrative Claims option in future years accordingly. We are not finalizing NQF 0021 measure titled “Annual Mon itoring for Beneficiaries on Persistent Medications,” for th e Administrative Claims option. The measure steward, NCQA, has withdrawn this measure from considerati on during NQF Steering Committee review and will update and resubmit the measure at a later date. Instead, we will substitute NQF 0022 “Use of High Risk Medicines in the Elderly,” which was included in Table 65 of the CY 2013 PFS proposed rule (77 FR 45000) and on which we had sought comment for including in the administrative claims option. Like NQF 0021, this process measure is a patient safety measure for medication management in the elderly. Additio nally, the measure was suggested for inclusion by several commenters due to its importance in beneficiary care and broad applicability to physicians. Additionally, based on our 2010 analys is of its use in the physician feedback program, it has a high level of reliability. Unlike NQF 0021, NQF 0022 remains endorsed by NQF.
Comment : Some commenters identified attribu tion of patients to physicians and risk adjustment as challenges with admi nistrative claims-based measures in general. Others noted that the current administrative claims-based measure set is primary care oriented and lacks measures appropriate for specialists. Response : We appreciate these comments and ha ve acknowledged above the challenges commenters associated with administrated claims-b ased measures that ma ke them an imperfect data source for measuring certain aspects of qualit y. Administrative claims-based measures will likely continue to comprise part of the measure se t for the value-based modifier, such as the cost measures and measures that extend across the continuum of care . CMS developed the administrative claims option to create an opportunity for physicia n practices that have not yet1064

invested in the infrastructure and capabilities otherwise require d to participate in PQRS to engage meaningfully in quality measurement a nd quality improvement. Ultimately, we believe that physician practices s hould actively gather and report quality data, such as through EHRs or registries. Thus, we do not anticipate that an option to participate in PQRS and the value-based payment modifier exclusively using administrative claims will continue beyond the first few years of the program.
Comment : Commenters also suggested removing NQF 0549 measure titled “Pharmacotherapy Management of COPD Exacerba tion,” because not all COPD patients should receive a corticoste roid and the measure does not take into account if a patient has possession of the medication at home. Response : We are not finalizing NQF 0549 “Pha rmacotherapy Management of COPD Exacerbation.” This measure was submitted and reviewed by NQF this year and was not recommended for continued endorsement due to que stions raised about th e measure’s validity.
Comment : Commenters suggested removing th e proposed NQF 0576 measure titled “Follow-up After Hospitalization for Mental Il lness” from the administrative claims-based measure set, because the measure would have mi nimal potential to distinguish physicians who are not mental health specialists from thos e who are thus making attribution a concern. Response : We appreciate this comment and concur that psychiatrists treating patients who have been hospitalized for mental illn ess should be held accountable for ensuring appropriate follow up after discharge. However, we believe that our obje ctive of effective care coordination and safe care transitions for patients with mental illness are best served when all physicians and providers involved in the care of a patient withmental illness who has been discharged from an inpatient care setting shar e accountability for effec tive care coordination. We are therefore finalizing this measure in the claims-based option as supported by many other1065

commenters. Comment : Commenters suggested removing th e proposed NQF 0543 measure titled “Statin Therapy for Beneficiaries with Coronary Artery Disease” from the administrative claimsbased measure set, because there are multiple influences on why patients may not obtain the medication. Response : We recognize that physicians play a critical role in influencing patient medical adherence, and the point made would obvi ate the use of all medication measures. We are therefore finalizing this measure in the cl aims-based option as supported by many other

commenters. Outcome Measures . Of the 19 measures we pr oposed for reporting using the administrative claims-based reporting mechanism, 4 of these proposed measures were outcome measures – All Cause Readmission, 30 day Post Discharge Visit, and the Acute and Chronic Preventive Quality Indicator (PQI) Composites. The following is a summary of the comments received on the proposed outcome measures av ailable for the administrative claims-based reporting mechanism.
Comment : Many commenters were opposed to the four outcome measures due to lack of NQF endorsement at the group or physician level, in adequate risk adjustment , lack of ability for verification by the physician group us ing their own data, or the lack of actionability by the physician groups. The PQIs were cited as population level measures, unlikely to be valid at the provider or smaller group level. Other commen ters stated that planned hospital readmissions may constitute appropriate care. And for the 30-day post-discharge follow-up visit measures, commenters pointed out that surgeons are subj ect to the 90-day global payment period and cannot generate a claim for a 30-day post-discharge follow-up visit, thus questioning the accuracy of the measure. Commenters also indi cated that there may be other ways to ensure1066

sufficient care coordination after a hospitalization that doe s not involve a visit within 30 days of discharge. Many commenters sugge sted four recently NQF endorse d care coordination measures to replace these four care coordination outcome measures. A substantial number of commenters from the consumer advocacy and physician value community supported all four of the outcome me asures as moving quality measurement in the forward direction and in partic ular singled out the use of co mposite scores as a method to increase reliability. Response : We appreciate the commenters’ suggestions. We are finalizing the all cause readmission measure and the Acute and Chronic Pr eventive Quality Indicator composites for use in the PQRS Administrative Claims option and fo r all groups of physicians subject to the valuebased payment modifier (see discussion below in Section III.K.2). The all cause readmission measure is NQF endorsed at the hospital level, ha s been respecified for groups of physicians, and we are using the all-cause readmission meas ure in the Medicare Shared Savings Program. Likewise, the individual PQI meas ures, while currently endorsed at the population level, have been respecified for medical groups and used in the physician feedback reports. Furthermore, we are collaborating with AHRQ, th e measure steward for the PQIs, about our use of PQI composite measures. We will be seeking NQF endorsement of the respecified all cause readmission measure and PQI composite measures. Both the all-cause readmission measure and the PQI measures have been respecified usi ng rigorous risk adjustment methods. We are redesigning our physician feedback reports to allow groups of physicians to verify who the patients included in these measures are, so that they can take appropr iate actions. We are persuaded by the comments about the 30-day pos t-discharge visit measure and we will not finalize that measure. We believe an effective Admi nistrative Claims option a nd a meaningful value-based1067 payment modifier in the long -run will place greater emphasis on outcome measures and we believe it is important to include outcome measures that highlight key areas for achieving better care for beneficiaries.

With regard to the suggestions to replace these outcome measures for four recently endorsed AMA-PCPI care coordination measures th at were recently NQF endorsed, we note that these suggested care coordination measures are all process measures, and they will be considered for the claims option of the PQRS program in 2014 in future rulemaking. Therefore, based on the comments received, as specified in Tables 123 and 124, we are finalizing 17 measures, comprised of 14 process and 3 outcome measures (2 of which are PQI composite measures), for inclusion in the PQRS administrative claims-based measure set for reporting for the 2015 PQRS payment adjustment only. TABLE 123: Process Measures for Eligible Professionals and Group Practices Who Report Using Administrative Claims fo r the 2015 PQRS Payment Adjustment Measures for the Administrative Claims Options for 2015 NQF
Number Measure Title Measure
Steward Domain of
Care
0576 Follow-Up After Hospitalization for Mental Illness Percentage of discharges for patients who were hospitalized for treatment of selected mental health disorders and who had an outpatient visit, an intensive outpatient encounter, or partial hospitalization with a mental health practitioner NCQA Care Coordination

0022 Use of High-Risk Medications in the Elderly: (a) Patients Who Receive At Least One Drug To Be Avoided Percentage of patients ages 65 years and older who received at least one high-risk medication in the measurement year (b) Patients Who Receive At Least Two Different Drugs To Be Avoided Percentage of patients 65 years of age and older who received at least two different high-risk medications in the measurement year NCQA Patient Safety

0555 Lack of Monthly INR Monitoring for Beneficiaries on Warfarin Average percentage of 40-day intervals in wh ich Part D beneficiaries with claims for warfarin do not receive an INR test during the measurement period. CMS Patient Safety 0577 Use of Spirometry Testing to Diagnose COPD Percentage of patients at least 40 years old w ho have a new diagnosis or newly active chronic obstructive pulmonary disease (COPD) who r eceived appropriate spirometry testing to confirm the diagnosis. NCQA Clinical Care

0543 Statin Therapy for Beneficiaries with Coronary Artery Disease Medication Possession Ratio (MPR) for statin th erapy for individuals over 18 years of age with coronary artery disease. CMS Clinical Care1068

0583 Lipid Profile for Beneficiarie s Who Started Lipid-Lowering Medications Percentage of patients age 18 or older st arting lipid-lowering medication during the measurement year who had a lipid panel checked within 3 months after starting drug therapy Resolution Health Clinical Care

0053 Osteoporosis Management in Women ≥ 67 Who Had a Fracture Percentage of women 67 years and older who suffered a fracture and who had either a bone mineral density (BMD) test or prescription for a drug to treat or prevent osteoporosis in the 6 months after the date of fracture. NCQA Clinical Care

0055 Dilated Eye Exam for Beneficiaries ≤ 75 with Diabetes Percentage of adult patients with diabetes ag ed 18-75 years who received a dilated eye exam by an ophthalmologist or optometrist during th e measurement year, or had a negative retinal exam (no evidence of retinopathy) by an eye care professional in th e year prior to the measurement year. NCQA Clinical Care

0057 HbA1c Testing for Beneficiaries ≤ 75 with Diabetes Percentage of adult patients with diabetes ag ed 18-75 years receiving one or more A1c test(s) per year. NCQA Clinical Care

0062 Urine Protein Screening for Beneficiaries ≤ 75 with Diabetes Percentage of adult diabetes patients aged 18-75 years with at least one test nephropathy screening test during the measurement year or who had evidence existing nephropathy (diagnosis of nephropathy or documentati on of microalbuminuria or albuminuria). NCQA Clinical Care

0063 Lipid Profile for Beneficiaries ≤ 75 with Diabetes Percentage of adult patients with diabetes aged 18-75 who had an LDL-C test performed during the measurement year
. NCQA Clinical Care

0075 Lipid Profile for Beneficiaries with Ischemic Vascular Disease Percentage of patients 18 years of age and older who were discharged alive for acute myocardial infarction (AMI), co ronary artery bypass graft (CAB G) or percutaneous coronary interventions (PCI) from January 1–November 1 of the year prior to the measurement year, or who had a diagnosis of ischemic vascular disease (IVD) during the measurement year and the year prior to measurement year, who had a complete lipid profile during the measurement year. NCQA Clinical Care

0105 Antidepressant Treatment for Depression Percentage of patients who were diagnosed with a new episode of depression and treated with antidepressant medication and who remained on an antidepressant medication treatment for: (a) at least 84 days (12 weeks) and (b) 180 days (6 months). NCQA Clinical Care

0031 Breast Cancer Screening for Women ≤ 69 Percentage of eligible women 40-69 who recei ve a mammogram in during the measurement year or in the year prio r to the measurement year. NCQA Clinical Care

Table 124: Outcome Measures for Eligible Pr ofessionals and Group Practices Who Report Using Administrative Claims for the 2015 PQRS Payment Adjustment NQF Number Measure Title Measure Steward Domain of Care N/A 1. Composite of Acute Prevention Quality Indicators (PQIs) N/A Care Coordinatio n 0279 Bacterial Pneumonia The number of admissions for bacterial pneumonia per 100,000 population. AHRQ

0281 UTI The number of discharges for urinary tract infection per 100,000 population Age 18 Years and Older in a one year time period AHRQ

0280 Dehydration The number of admissions for de hydration per 100,000 population. AHRQ N/A 2. Composite of Chronic Prevention Quality Indicators (PQIs) N/A Care Coordinatio n Diabetes Composite1069

0638 Uncontrolled diabetes The number of discharges for uncontrolled diabetes per 100,000 population Age 18 Years and Older in a one year time period. AHRQ

0272 Short Term Diabetes complications The number of discharges for diabetes short-term complications per 100,000 Age 18 Years and Older population in a one year period. AHRQ

0274 Long term diabetes complications The number of discharges for long-term diabetes complications per 100,000 population Age 18 Years and in a one year time period. AHRQ

0285 Lower extremity amputation for diabetes The number of discharges for lower-extremity amputation among patients with diabetes per 100,000 population Age 18 Years in a one year time period. AHRQ

0275 COPD The number of admissions for chronic obstructive pulmonary disease (COPD) per 100,000 population. AHRQ

0277 Heart Failure Percent of the population with admissions for CHF. AHRQ N/A 3. All Cause Readmission The rate of provider visits within 30 days of discharge from an acute care hospital per 1,000 discharges among eligible beneficiaries assigned. CMS Care Coordinatio n

7. Maintenance of Certificati on Program Incentive: Self-Nomin ation and Qualification Process for Entities Wishing to be Qualified for the 2013 and 2014 Maintenance of Certification Program Incentives We proposed that new and previously qualifie d entities wishing to become qualified to provide their members with an opportunity to earn the 2013 and/or 2014 Maintenance of Certification Program incentives undergo a self -nomination and qualific ation process (77 FR 44982). Once qualified, we proposed that the entity w ould be able to submit data on behalf of its eligible professionals. Maintenance of Certification Program Incentive: Self-Nomination Process . For the selfnomination process, we proposed that an entity wishing to be qualified for the 2013 and/or 2014 Maintenance of Certification Program incentive would be required to su bmit a self-nomination statement containing all of the fo llowing information via the web:

● Provide detailed information regarding th e Maintenance of Certification Program with1070 reference to the statutory re quirements for such program.

● Indicate the organization sponsoring the Maintenance of Certification Program, and whether the Maintenance of Ce rtification Program is sponsor ed by an American Board of Medical Specialties (ABMS) boa rd. If not an ABMS board, indicate whether and how the program is substantially equivalent to the ABMS Maintenance of Certific ation Program process.

● Indicate that the program is in existence as of January 1 the year prior to the year in which the entity seeks to be qualified for the Ma intenance of Certification Program incentive. For example, to be qualified for the 2013 Main tenance of Certification Program incentive, the entity would be required to be in existence by January 1, 2012.

● Indicate that the program has at least one (1) active participant.

● The frequency of a cycle of Maintenance of Certification for the specific Maintenance of Certification Program of the sponsoring organization, including what constitutes "more frequently" for both the Maintena nce of Certification Program itself and the practice assessment for the specific Maintenance of Certificat ion Program of the sponsoring organization.

● Confirmation from the board that the pr actice assessment will occur and be completed in the year the physician is par ticipating in the Maintenance of Certification Program Incentive.

● What was, is, or will be the first ye ar of availability of the Maintenance of Certification Program practice assessment fo r completion by an eligible professional.

● What data is collected under the patient experience of care survey and how this information would be provided to CMS.

● Describe how the Maintenance of Certific ation program monitors that an eligible professional has implemented a quality improvement process for their practice.

● Describe the methods, and data used under th e Maintenance of Cer tification Program, and provide a list of all measures used in the Maintenance of Ce rtification Program for the year1071 prior to which the entity seeks to be qualified for the Maintenance of Certification Program incentive (for example, measures used in 2012 for the 2013 Maintenance of Certification Program incentive), including the title and descri ptions of each measure, the owner of the measure, whether the measure is NQF endorsed, and a link to a website containing the detailed specifications of the measures, or an electronic file containing the detailed specifications of the

measures. We invited but received no public comment on our proposed self-nomination process for entities who wish to be qualified for the 2013 and 2014 Maintenance of Certification Program incentive. Therefore, we are finalizing the self-nomination process for boards wishing to participate in the Maintenance of Certif ication Program incentive, as proposed. Maintenance of Certification Program Incentive: Qualification Process . For the qualification process, we proposed that an entity must meet all of the following requirements to be considered for qualification for purposes of the 2013 and 2014 Maintenance of Certification Program incentives (77 FR 44983):

● The name, NPI and applicable TINs of eligible professionals who would like to participate for the 2013 and/or 2014 Maintena nce of Certificati on Program incentives.

● Attestation from the board that the in formation provided to CMS is accurate and complete.

● The board has signed documentation from e ligible professional(s) that the eligible professional wishes to have the information released to us.

● Information from the patient experience of care survey.

● Information certifying the el igible professional has participated in a Maintenance of Certification Program for a year, “more frequently ” than is required to qu alify for or maintain board certification status, in cluding the year the physicia n met the board certification1072 requirements for the Maintenance of Certification Program, and the year the eligible professional participated in the Maintenance of Certificati on Program “more frequently ” than is required to maintain or qualify fo r board certification.

● Information certifying the eligible profe ssional has completed the Maintenance of Certification Program practice assessment at l east one time each year the eligible professional participates in the Maintenance of Certification Program Incentive. We proposed this self-nomination and qualif ication process because the process is identical to the self-nomination and qualif ication process finalized for the 2011 and 2012 Maintenance of Certification Program incentiv es and we felt such requirements remain appropriate. Because the incentives only run th rough 2014, we felt it was important to keep the requirements consistent with what has been required for the 2011 and 2012 Maintenance of Certification Program incentives. We invited public comment on the proposed qua lification process for entitles entities who wish to be qualified for the 2013 and 2014 Maintena nce of Certification Program incentive. The following is summary of the comments we received regarding these proposals.
Comment : One commenter suggested that those en tities that have pr eviously undergone the qualification process and were previously qualified to participate in this Maintenance of Certification Program incentive be automatically qualified for the following year. Response : We agree with the commenter’s sugges tion to allow boards that were fully qualified in a prior program year and successfully submitted data to be fully qualified after CMS review of their ap plication. Since the qualification process is the same from year to year, CMS believes that requiring boards to undergo this pro cess every year is redunda nt. CMS agrees that this will allow more time for returning boards to encourage participation with their diplomats.
Comment : One commenter suggested that newly participating boards be allowed to1073 bypass the qualification process if they administer a qua lified registry. Response : We agree with the commenter’s sugges tion. The data submission process for Maintenance of Certification entities is simila r to the registry data submission process. Therefore, it would seem redundant for a specia lty board that already possesses a qualified registry to have to undergo another separate qualification process to participate in the Maintenance of Certification Prog ram incentive, as the entity’s products and characteristics have already been vetted when it submitted its registry for qualification under PQRS. Therefore, we do not believe it is necessary for specialty boards that administer PQRS qualified registries to undergo a separate qualification process for pur poses of the Maintena nce of Certification Program incentive. Therefore, we are not requ iring boards who wish to participate in the Maintenance of Certification Pr ogram incentive for the first time to undergo the Maintenance of Certification Program incentive qualification proce ss if they also maintain a PQRS qualified registry. However, we note that these specialty bo ards must still self-nominate for each year the specialty board wishes to participate in Maintenance of Certification Program incentive.
Comment : One commenter believed that the requirements for receiving a Maintenance of Certification incentive payment are too onerous for both physicians and participating boards. Response : We appreciate the commenter's feedb ack. We understand that physicians already participating in Maintena nce of Certification programs ar e already taking proactive steps to maintain their clinical skill s and education. In fact, we de fer to the boards for what is necessary to demonstrate a physic ian's ability to maintain certif ication. However, given the requirement that a physician participate in a Maintenance of Certif ication program "more frequently" than is required to maintain board certification, we believe that earning an additional Maintenance of Certification incentive under PQ RS involves extra effort by the physician. Please note that we work with the participat ing boards to determine what extra steps are1074 necessary to earn this incentive.
Comment : One commenter seeks clarification on how physicians are to participate in a Maintenance of Certification Prog ram "more frequently" than is re quired to maintain or qualify for board certification. Response : Please note that more information and guidance about how to participate in a Maintenance of Certification Program incentiv e "more frequently" for purposes of the Maintenance of Certification Program incentive is available on the PQRS website at http://www.cms.gov/Medicare/Quality -Initiatives-Patient-AssessmentInstruments/PQRS/index.html

. Comment : One commenter requested that CMS e xplore opportunities to leverage the Maintenance of Certification structure that exis ts within the specialty boards to reduce redundant reporting requirements and enhance the value of PQRS for physicians and their patients. Response : We appreciate the commenter's feedbac k. CMS has worked closely with the specialty boards to establish requirements for earning the additional Maintenance of Certification Program incentive under PQRS. In fact, the boards provide the guidelines for determining what is necessary to demonstrate a physician' s ability to maintain certification. Based on the comments received and for the reasons discussed above, we are finalizing the qualification process for boards wishing to become qualified to participate in the Maintenance of Certification Program incentive. However, , boards that were previously qualified as a Maintenance of Certification Progr am entity or newly participating boards that utilize a previously qualified registry for their Maintenance of Certification Program data will not need to undergo the qualification process annua lly. Rather, these entiti es will be qualified after these entities complete their self-nomina tion statements. However, please note that previously qualified boards or boards that use a previously qualified regi stry must still self-1075 nominate to participate in the Maintenance of Certification Program incentive for each year the boards wish to participate. Fo r boards wishing to newly become qualified, we note that, due to a delay in the availability of the testing tool to qualify the boards, this qualification process will occur later in time for 2013. Please note that we are also making technical changes in §414.90(d) due to changes in the composition of §414.90(c) to specify the incentive amounts for the 2013 and 2014 PQRS incentives. We ar e also making a technical change at §414.90(d)(1)(iii)(B)(2)(i), as this se ction incorrectly references (d )(2)(11); the correct reference is (d)(1)(iii). 8. Informal Review We established an informal review process for 2012 and beyond in the CY 2012 Medicare PFS final rule (76 FR 73390). In this final rule with comment period, we addressed the additional parameters we proposed for eligible professionals and group practices subject to a PQRS payment adjustment reques ting an informal review. For eligible professionals and group practices that are subject to the payment adjustments that wish to request an informal review, in addition to the requirements we previously established, we proposed the following:

● An eligible professional el ecting to utilize the informal re view process must request an informal review by February 28 of the year in which the payment adjustment is being applied. For example, if an eligible prof essional requests an informal re view related to the 2015 payment adjustment, the eligible professional would be re quired to submit his/her request for an informal review by February 28, 2015. We felt this de adline provided ampl e time for eligible professionals and group practices af ter their respective claims begi n to be adjusted due to the payment adjustment.

● Where we find that the elig ible professional or group prac tice did satisfactorily report for the payment adjustment, we would to cease application of the payment adjustment and1076 reprocess all claims that have been er roneously adjusted to date (77 FR 44983). We invited public comment on our proposals for the PQRS informal review process. The following is a summary of the comments we received regarding the proposed additional parameters for the PQRS informal review process.
Comment : Several commenters supported our proposal to establish an informal review process for the PQRS payment adjustment. Response : We appreciate the commenters' feedback and are finalizing an informal review process for the PQRS payment adjustments that is similar to the informal review process established for the PQRS incentives.
Comment : One commenter supported our propose d deadline of February 28 of the payment adjustment year for eligible professiona ls and group practices to request an informal review of the PQRS payment adjustment. Response : Based on the comments received, we are fi nalizing a deadline of February 28 of the payment adjustment year for eligible professionals a nd group practices to request an informal review of the PQRS payment adjustment.
Comment : One commenter supported CMS' propos al to provide written responses to those eligible professionals and group practices seeking an informal review request. Response : We appreciate the commenter's feedback and we are finalizi ng our proposal to provide a timely, written response to eligible professionals and group practices seeking an informal review of the applicability of the PQRS payment adjustment.
Comment : One commenter supported our proposal to make eligible professionals and group practices whole should CMS find error. Response : We believe it is important to rectify error should CMS find that an error has occurred in application of the PQRS payment adjustment during the informal review process.1077
Therefore, where we find that th e eligible professional or group pr actice did satisfactorily report for the payment adjustment, we will cease application of the payment adjustment and reprocess all claims that have been e rroneously adjusted to date. Based on the comments received and for the re asons stated previously, we are finalizing these additional parameters for the PQRS inform al review process as it relates to the PQRS payment adjustments. We are finalizing changes to §414.90 to reflect the PQRS informal review process for the PQRS incentives and payment adjustments. H1. The Electronic Prescribing (eRx) Incentive Program We established the requirements for the 2013 and 2014 eRx Incentive Program in the CY 2012 Medicare PFS final rule (76 FR 73393). This section addresses additional final requirements for the 2013 and 2014 eRx Incentive Program. Please note that, during the comment period following the proposed rule, we received comments that were not related to our specific proposals for the eRx Ince ntive Program in the CY 2013 Medicare PFS proposed rule. While we appreciate the commenters' feedback and intend to use these comments to better devel op the eRx Incentive Program, these comments will not be specifically addressed in this CY 2013 Medicare PFS final rule. 1. Definition of Group Practice Under §414.92(b) a group practice is one that, defined at §414.90(b), that is participating in the Physician Quality Reporting System; or in a Medicare-approved dem onstration project or other Medicare program, under which Physicia n Quality Reporting System requirements and incentives have been incorporated; and has indicate d its desire to participate in the electronic prescribing group practice option. Please note that the definition of group practice for the eRx Incentive Program is therefore tied to the defi nition of group practice under PQRS. Since we are changing the definition of group pr actice in PQRS to allow groups of 2-24 eligible professionals1078 to participate in PQRS as a group practice, accordingly, grou p practices of 2-24 eligible professionals will be able to pa rticipate in the eRx Incentive Program as a group practice in 2013 (that is, for the 2013 incentive and 2014 payment adjustment). In addition, we would like to clarify the requirement under §414.92(b) that a group practice under the eRx Incentive Program must be “participating in the Physician Quality Reporting System”. We developed this definitio n in light of our goals for group practices to report under both programs, as well as operationa l considerations for administering the group practice reporting option under the PQRS and ERx Incentive Program. In particular, we expect that group practices participating in the eRx In centive Program as a group practice will also be participating in PQRS as a group practice. With regard to “participation,” we note that we have never required nor indicated that group practices under the eRx GPRO must report PQRS quality measures to demonstrate participation in the PQRS for purposes of this de finition. In the past, we have required that group pr actices wishing to participate in the eRx Incentive Program under the group practice reporting opti on (eRx GPRO) must complete a self-nomination statement stating the group practice’s intent to participate in PQRS as a gr oup practice. We have viewed that as an example of “participation.” Howe ver, because we believe submission of a selfnomination statement for PQRS as an extra administrative step we have required in order for group practices to participate in the eRx GPRO, in 2013, we no longe r view completion of a selfnomination statement to participate in PQRS under the PQRS group prac tice reporting option (PQRS GPRO) as necessary to demonstration “participation” by group practices under the eRx Incentive Program. Therefore, the statement to be “participating in the Physician Quality Reporting System” is merely an indication but not a requirement that we expect that group practices participating in the eRx Incentive Program as a group practice will also be participating in PQRS as a group practice.1079

2. Alternative Self-Nomination Process for Certain Group Practices Under the eRx GPRO In the CY 2012 Medicare PFS final rule (76 FR 73394), we established that a group practice wishing to participate in the eRx In centive Program under the eRx GPRO must selfnominate via the web. However, we proposed an alternative submission mechanism for selfnomination by groups participating in the Medicare Shared Savi ngs Program, Pioneer ACO, PGP Demonstration, or other Medicare -approved demonstration project or other Medicare program (77 FR 44983). Specifically, we proposed that th e participating TINs w ithin these groups that wish to participate in the eRx Incentive Program using the eRx GPRO wo uld be required to submit a self-nomination statement by sending a lette r indicating its intent to participate in the eRx Incentive Program under the eRx GPRO. We also proposed that th e group practice would be required to submit an XML file describing th e eligible professionals included in the group practice. We proposed this alternative subm ission mechanism for group practices that are participating as groups in the Medicare Shar ed Savings Program, Pi oneer ACO, or PGP Demonstration because it is not technically feasible for CMS to receive this information from these group practices via the web. We invited public comment on this proposed alternative mechanism for submitting self-nomination statemen ts for groups participating in the Medicare Shared Savings Program, Pioneer ACO, and PGP demonstration and the pr oposed requirement to provide an XML file to CMS for the types of gr oup practices identified above that want to participate in the eRx Incentive Program usi ng the eRx GPRO. We received no comments regarding these proposed alternat ive methods related to the self-nomination process for group practices participating in th e Medicare Shared Savings Pr ogram, Pioneer ACO, and PGP demonstration that wish to participate in th e eRx Incentive Program using the eRx GPRO. Therefore, we are finalizing an alternative se lf-nomination process for these aforementioned groups. However, as we believe that it would be more efficient to accept self-nomination1080 statements electronically, we will not accept thes e self-nomination statements via U.S. mail. Rather, we will accept these self-nomination statemen ts via email. We are also not finalizing the requirement that these group practices provide an XML file to CMS. The XML file typically provides CMS with a list of the eligible prof essionals (defined by th eir individual rendering National Provider Identification numbers or NPIs ) within the group practice. Since we do not need NPI-level information to analyze group pr actice reporting, we no longer need this XML file. In addition, in the CY 2012 PFS final rule with comment period, we stated we would accept self-nomination statements for group practices that want to participate in the GPROs for PQRS and the eRx Incentive Program via th e web (76 FR 73315 and 76 FR 73394). We note that this web page is only available for t hose group practices who wish to submit a selfnomination statement to participate in both th e PQRS and eRx Incentive Program under the respective GPROs. Therefore, it will not be technically feasible to accept self-nomination statements via this web page from group practices who wish to submit a self-nomination statement to participate in the eRx GPRO only. Group practices wishing to submit a separate GPRO self-nomination statement to participate in the eRx In centive Program only must follow the alternative self-nomination pr ocess that group practices partic ipating in the Medicare Shared Savings Program using the eRx GPRO follow (76 FR 73395). We also note that, in the CY 2012 Medicare PFS final rule, we established a deadline of January 31 of the applicable program year (f or example, January 31, 2013 for the 2013 program year) for group practices to submit a self-nomina tion statement to partic ipate in the eRx GPRO (76 FR 73316). Although, as discussed in sectio n III.G, we have extended the deadline for group practices wishing to participate in the GPRO in PQRS to the Fall of the applicable program year (for example, Fall 2013 for the 2013 program yea r), for operational reasons, group practices1081 wishing to participate in the eRx Incentive Program under the eRx GPRO for 2013 must submit its self-nomination statement by January 31, 201 3 as finalized in the CY 2012 Medicare PFS final rule. We understand that having two se parate deadlines for submitting GPRO selfnomination statements for PQRS and the eRx Incentive Program may ca use confusion for group practices who have submitted self-nomination st atements for PQRS and eRx simultaneously in previous years. However, because the 2014 6- month payment adjustment reporting period (that is, January 1, 2013 – June 30, 2013) occurs prior to Fall 2013, we must ma intain a deadline of January 31, 2013 for those group practices wishing to participate in th e eRx Incentive Program as a group practice using the eRx GPRO for reporting periods occurring 2013. We realize that having two separate self -nomination dates of January 31, 2013 and Fall 2013 for self-nominating to participate in the GPRO for the eRx Incentive Program and PQRS respectively may cause additional administrative concerns, such as situations where a group practice may change its TIN between June 30, 2013 (after the 6-month 2014 payment adjustment reporting period) and Fall 2013. We will try to work with group practices so that they are aware of the applicable deadlin es and procedure. 2. The 2013 Incentive: Criterion for Being a Su ccessful Electronic Prescriber for Groups Comprised of 2-24 Eligible Professionals Se lected to Participat e under the eRx GPRO We proposed to add another criterion for becoming a successful electronic prescriber under the program for the 2013 Incentive for groups of 2-24 eligible profe ssionals that may now participate in the eRx Incen tive Program using the eRx GPRO in 2013 (77 FR 44983-44984). (For the other criteria we previously adopt ed for the eRx GPRO, please see 76 FR 73407). Specifically, we proposed the following criterion fo r being a successful electronic prescriber for group practices participating in the eRx GPRO comprised of 2- 24 eligible professionals for purposes of the 2013 eRx incentive: report the elect ronic prescribing measure’s numerator code1082 during a denominator-eligible encounter fo r at least 225 times during the 12-month 2013 incentive reporting period (January 1, 2013—December 31, 2013). We proposed a lower criterion for group practices par ticipating under the eRx GPRO with 2-24 eligible professionals because we understand that their smaller sizes necessitate a lower reporting threshold. We proposed this reporting threshold because this re porting threshold is familiar to group practices, as this was the threshold established for group practices comprised of 11-25 eligible professionals that participated in the GPRO II in 2011 (75 FR 73509). We invited public comment on our proposed crit erion for being a succ essful electronic prescriber for the 2013 incentive for groups comp rised of 2-24 eligible professionals. The following is a summary of the commen ts we received on this proposal.
Comment : Several commenters generally supported our proposal to establish criteria for being a successful electronic prescriber for group practices compri sed of 2-24 eligible professionals. However, some commenters stated that our pr oposed reporting threshold for a group practice of 2-24 eligible prof essionals to become a successful electronic prescriber is too high, particularly for a group comprised of 2 elig ible professionals. One commenter suggested applying a percentage threshold, similar to the electronic prescr ibing criteria established under the EHR Incentive Program. Other commenters s uggested a tiered approach similar to the criteria for becoming a successful electronic pres criber previously established under eRx GPRO II (75 FR 73509). One of these commenters also suggested that, in the al ternative, the proposed threshold be lowered. Commenters stated that group practices of 2-24 eligible professionals should be required report the electronic prescr ibing measure at least 75 times to become a successful electronic prescriber for the 2013 incentive. Response : We believe it is important to establish an electronic prescribing threshold that group practices of 2-24 eligible professionals can reasonably attain to become successful1083 electronic prescribers. As we explain in grea ter detail further below, we agree with the commenters’ suggestion and theref ore, we are finalizing a repor ting threshold of 75 times. For the suggestion to adopt a percentage threshold, we prefer to establish a reporting count as the established criteria for becoming a successful electronic prescriber for larger groups utilize a reporting count rather th an a percentage. Therefore, we would like to remain consistent in the reporting criteria that were previously es tablished for larger group practices participating in the eRx GPRO. For the tiered approach, we believe that adding several tiers for reporting for smaller group practices would add to the complexity of the eRx Incentiv e Program. To streamline the requirements for becoming a successful electronic prescriber for the eRx Incentive Program, we prefer one criterion for all group practices of 2- 24 eligible professionals using the eRx GPRO. We believe that the proposed threshold of 75 o ffered by commenters is reasonable, particularly because the eRx Incentive Program previously required group practices of 2-10 eligible professionals participating in the eRx GPRO II to report the electronic prescribing measure at least 75 times (75 FR 73509). We note that our proposed threshold of reporting the electronic prescribing measure was also cons istent with criteria we esta blished under GPRO II in 2011, but we understand the desire to lower the threshold to 75. We believe that th e reporting threshold of 75 also achieves the program goal of ensuring that eligible profe ssionals are generating prescriptions electronic ally. Therefore, based on the comm ents received, we are finalizing a lower threshold for reporting the electronic prescribing measure of 75 rather than 225. To be a successful electronic prescriber for the 2013 in centive, group practices comprised of 2-24 eligible professionals that are participating in the eRx GPRO must report the electronic prescribing measure at least 75 times during the applicable 12-m onth reporting period (that is, January 1, 2013 – December 31, 2013) for the 2013 incentives.1084 3. The 2014 Payment Adjustment: Criterion for Be ing a Successful Electronic Prescriber for Group Practices Comprised of 2-24 Eligible Profe ssionals Selected to Participate under the eRx
GPRO We proposed to change the minimum group prac tice size from 25 to 2 accordingly with PQRS and proposed to add another criterion for be ing a successful electr onic reporter under the program for the 2014 payment adjustment (77 FR 44984) . (For the other criteria we previously adopted for the eRx GPRO Reporting Option, pl ease see 76 FR 73412-73414). Specifically, we proposed the following criterion for being a successf ul electronic prescriber for purposes of the 2014 payment adjustment for group practices co mprised of 2-24 eligible professionals participating under the eRx GPRO : Report the electronic prescrib ing measure's numerator code at least 225 times for the 6-month 2014 paymen t adjustment reporting period (January 1, 2013— June 30, 2013). We proposed this lower criterio n for group practices par ticipating under the eRx GPRO with 2-24 eligible professi onals because we understand that their smaller sizes necessitate a lower reporting threshold. In addition, we noted that this reporting th reshold is familiar to group practices, as this was the threshold esta blished for group practices comprised of 11-25 eligible professionals that participated in the GPRO II in 2011 (75 FR 73509). We invited public comment on the proposed crit erion for being a succ essful electronic prescriber for the 2014 eRx payment adjustment for the 6-month payment adjustment reporting period for group practices composed of 2-24 eligib le professionals. The following is a summary of comments we received regarding this proposal.
Comment : Commenters generally provided the sa me comments regarding this proposed criterion for becoming a successful electronic pr escriber for the 2014 payment adjustment as provided for the proposed criterion for becoming a successful electronic prescriber for the 2013 incentive. Specifically, several commenters generall y supported our proposal to establish criteria1085 for becoming a successful electronic prescriber for group practices comprised of 2-24 eligible professionals. However, some commenters stated that our pr oposed reporting threshold for a group practice of 2-24 eligible prof essionals to become a successful electronic prescriber is too high. One commenter suggested applying a per centage threshold, similar to the electronic prescribing criteria establishe d under the EHR Incentive Program. Other commenters suggested a tiered approach similar to the criteria for becoming a successful el ectronic prescriber previously established under eRx GPRO II ( 75 FR 73509). One of these commenters also suggested that, in the alternative, the proposed threshold be lowered. Group practices of 2-24 eligible professionals should be required report the electronic prescribing measure at least 75 times to become a successful electronic pres criber for the 2014 pa yment adjustment. In addition to these comments, some comme nters supported our proposed criteria to report the electronic prescribing measure at leas t 225 times to become a successful electronic prescriber for the 2013 incentive but believed that this 225 thre shold is too high for the 2014 payment adjustment, as group practices will onl y have 6 months as opposed to 12 months to meet this threshold. The commenters added that the threshold is especially high for dermatologists who may not see this many Me dicare Part B patients during the 6-month 2014 payment adjustment reporting period. Response : For the same reasons we discussed above with regard to the threshold for the 2013 incentive, we agree with the points raised by commenters. In addition, for reporting under the eRx GPRO, it is our desire to keep with the trend of establishing similar criteria for the incentives as payment adjustments. It is our desire to finalize the same criterion for the 2014 payment adjustment as finalized for the 2013 in centive. Therefore, based on the comments received and for the reasons we stated for establishing a lower threshold of 75 for the 2013 incentive, we are finalizing a lower threshold for reporting the electronic prescribing measure for1086 the 2014 payment adjustment of 75 instead of 225. To be a successful electronic prescriber for the 2014 payment adjustment, group practices compri sed of 2-24 eligible pr ofessionals that are participating in the eRx GPRO must report the electronic prescr ibing measure at least 75 times during the applicable 20 14 6-month payment adjustment reporting period. 4. Analysis for the Claims-based Reporting Mechanism We understand that, in certain instances, it is permissible for an eligible professional to have their Medicare Part B clai ms reprocessed. However, we ra ised concerns about eligible professionals resubmitting claims for the sole reason of attaching a G-code for purposes of reporting under the ERx Incentive Program (rather than reporting such data at the time the claim was initially submitted). Therefore, we proposed to modify §414.92 to indicate that under the eRx Incentive Program, if an eligible professi onal re-submits a claims for reprocessing, the eligible professional may not att ach a G-code at that time. The following is a summary of comments we received on this proposal.
Comment : Some commenters disagreed with our proposal to modify § 414.92 to indicate that G-codes cannot be attached to claims that are re-submitted for reprocessing for purposes of the eRx Incentive Program. Commenters urged us to allow the reopening or resubmission of claims for the sole purpose of a ttaching a reporting code on a claim. Response : To avoid the reprocessing of claims so lely to report quality measure for the eRx Incentive Program, we believe such a policy is needed and therefore, we are finalizing our change to the regulation at §414.92. In addition, we note that even though professionals may prefer this practice, it is not practically feasible to allow eligible professionals and group practices to resubmit a claim for the sole pur pose of attaching a reporting code on a claim for purposes of the eRx Incentive Prog ram. Allowing eligible profe ssionals to resubmit claims for reporting purposes opens the potential for the repr ocessing of millions of claims, which would be1087 overly burdensome and costly for CMS. Theref ore, we are finalizi ng our proposal to add §414.92(f)(2)(i)(A) to indicate if an eligible professional re-submits a Medicare Part B claim for reprocessing, the eligible professional may not attach a G-code at that time for reporting on the electronic prescribing measure. We note that has been CMS’ policy not to accept quality data from claims that were resubmitted since the incep tion of PQRS (where the electronic prescribing measure was first availabl e for reporting) in 2007. 5. Proposed Significant Hardship Exemptions Section 1848(a)(5)(B) of the Act provides that the Secretary may, on a case-by-case basis, exempt an eligible professional from th e application of the payment adjustment, if the Secretary determines, subject to annual renewal, that compliance with th e requirement for being a successful electronic pr escriber would result in a significant hardshi p. In the CY 2012 final rule with comment period, we finalized, as set forth at §414.92(c)(2)(ii)(B), four circumstances under which an eligible professional or eRx GP RO can request consideration for a significant hardship exemption for the 2013 and 2014 eRx payment adjustments (76 FR 73413):

• The eligible professional or gr oup practice practices in a rura l area with limited high speed internet access.

• The eligible professional or group practice practices in an area with limited available pharmacies for electronic prescribing.

• The eligible professional or group practice is un able to electronically prescribe due to local, state, or Federal law or regulation.

• The eligible professional or group practice has limited prescribing activity, as defined by an eligible professional generating fewer than 100 prescriptions during a 6-month reporting period.1088

We have received feedback from stakeholde rs requesting significant hardship exemptions from application of the payment adjustment based on participation in the EHR Incentive Program, a program which requires a certain level of electronic prescribing activity. Under the EHR Incentive Program, eligible professionals 4 may receive incentive payments beginning in CY 2011 for successfully demonstrating “mean ingful use” of Certified EHR Technology (CEHRT) and will be subject to payment adjustments beginning in CY 2015 for failure to demonstrate meaningful use. For further explan ation of the statutory au thority and regulations for the EHR Incentive Program, we refer readers to the EHR Incentive Program—Stage 1 final rule (75 FR 44314) and the EHR Incentive Program —Stage 2 final rule (77 FR 53968). As a result of such feedback, we believe that in cert ain circumstances it may be a significant hardship for eligible professionals and gr oup practices who are participants of the EHR Incentive Program to comply with the successful electronic prescr iber requirements of the eRx Incentive Program. Therefore, we proposed to revi se the regulation at §414.92(c)(2)(ii )(B) (77 FR 44984) to add the following two additional significant hardship exemption categories for the 2013 and 2014 payment adjustments:

• Eligible professionals or group practices who achieve me aningful use during certain eRx payment adjustment reporting periods.

• Eligible professionals or gr oup practices who demonstrate in tent to participate in the EHR Incentive Program and adop tion of Certified EHR Technology. The following is a summary of general commen ts we received regarding our proposal to add these two additional significant hardsh ip exemption categories for the 2013 and 2014 payment adjustments:

4 “Eligible professional” is defined for the EHR Incentive Program at 42 CFR 495.4, 495.100, and 495.304.1089

Comment : One commenter opposed our proposal to add two new add itional significant hardship exemption categories re lated to participation in the EHR Incentive Program. The commenter notes that CMS implemented the eRx Incentive Program in 2009 and eligible professionals have had sufficient time in which to make arrangements to implement the program. The commenter is concerned these two new ha rdship exemptions may have the unintended consequence of discouraging eligib le providers’ rapid participati on in the electr onic prescribing
program. Response : We appreciate the commenter's concern a nd note that it is not our intention to discourage participation in th e eRx Incentive Program through the establishment of these significant hardship exemption categories. We note that incentives under the eRx Incentive Program are available until 2013 and hope that th e potential to earn an incentive under the eRx Incentive Program will encourage eligible profe ssionals who are not also receiving incentives under the Medicare EHR Incentive Program to participate in the eR x Incentive Program. With respect to the argument that eligible professionals have had adequate time to acquire systems capable for electronic prescrib ing, we note that although the eRx Incentive Program was established in 2009, and has tran sitioned from bonus incentives to payment adjustments beginning in 2012, we believe that with the establishment of the EHR Incentive Program, which also includes an electronic pres cribing objective, eligib le professionals and group practices choosing to par ticipate in the eRx Incentive Program and the EHR Incentive Program may have had difficulties with regard to searching for products that had the capabilities to meet requirements for both programs. As we noted in the proposed rule (77 FR 44984), we received stakeholder feedback regarding the di fficulties of choosing, purchasing, and setting up an EHR system that is capable for use for both programs. Therefore, we believe that these1090 significant hardship exemption categories are ap propriate for eligible professionals and group practices such as these.
Comment : Several commenters supported our proposed two additional significant hardship exemption categories re lated to participation in the EHR Incentive Program for the 2013 and 2014 payment adjustments. Response : We agree with the commenters’ gene ral support of these two additional significant hardship exemptions. Therefore, ba sed on the comments receiv ed and for the reasons stated previously, we are finalizing, as discussed in greater detail, these two additional significant hardship exemptions related to participation in the EHR Incentive Program for the 2013 and 2014 payment adjustments. a. Eligible professionals or group practices who achieve meaningful use during the 2013 and 2014 payment adjustment reporting periods. Under Stage 1 of meaningful use for the EH R Incentive Program, an eligible professional is required to meet certain objec tives and associated measures to achieve meaningful use. One of these objectives is for the eligible professional to generate and transmit permissible prescriptions electronically, and the measure of whether the eligible professi onal has met this objective is more than 40 percent of all permissible prescr iptions written by the elig ible professional are transmitted electronically using Certified EH R Technology (§495.6(d)(4)). We note that the EHR Incentive Program and the eRx Incentive Program share a common goal of encouraging electronic prescribing an d the adoption of technology that en ables eligible professionals to electronically prescribe. This goal is advan ced under each program via the respective program requirements – the electronic prescribing objec tive under the EHR Incentive Program and the requirement that an EP be a “successful elect ronic prescriber” under th e eRx Incentive Program. Indeed, both programs require that the eligible professionals indicate their electronic prescribing1091 activity. Under the EHR Incentive Program, an eligible professional must attest to the percentage of his or her permissible prescr iptions that were generated and transmitted electronically using Certified EHR Technology during the applicable EHR reporting period, which must exceed 40 percent. Under the eRx Incentive Program, to avoid the payment adjustment, an eligible professional must be a successful electronic prescriber, which is achieved by the reporting of the eRx quality measure a certa in number of instances during the applicable reporting period (each instance of reporting of the eRx quality measure, which includes reporting of specific quality data codes, signifies that the professional ge nerated an electronic prescription for a specified service or encounter). In mo st cases, we believe the electronic prescribing objective of meaningful use would be a more rigorous standard for eligible professionals to meet than the standard adopted under the eRx Incentive Program (as dem onstrated via the reporting of the eRx quality measure). In addition, there seems to be no added be nefit with regard to reporting (presumably lower) elect ronic prescribing ac tivity under the eRx Incentive Program given that the identical goals (encouraging elect ronic prescribing) of both programs would have been fulfilled through the eligible professional’s achievement of meaningful use. For those reasons, we believe it may pose a significant ha rdship for eligible professionals who are meaningful EHR users to additionally comply with the requirements of being a successful electronic prescriber under the eRx Incentive program. For the reasons stated, under this proposed significant ha rdship category, we proposed that individual eligible professionals (and every eligible prof essional member of a group practice using the eRx GPRO for the 2014 pa yment adjustment only) would need to achieve meaningful use of Certified EHR Technology for a continuo us 90-day EHR reporting period (as defined for the EHR Incentive Program) that falls within the 6-month reporting period (January 1 - June 30, 2012) for the 2013 eRx payment adjustment or the 12- or 6-month reporting periods (January 1-1092 December 31, 2012 or January 1 – June 30, 2013, respectively) for the 2014 eRx payment adjustment to be eligible for this signifi cant hardship exemption (77 FR 44985). We also proposed that for purposes of the 2013 and 2014 eRx payment adjustments this hardship exemption category would apply to individual EPs and group practices (tha t is, every member of the group) who instead achieve meaningful use of Certified EHR Technology for an EHR reporting period that is the full CY 2012. We invited public comment on this proposed significant hardship exemption category. The following is a summary of the comments received related to the proposed significant hardship exemption category: e ligible professionals or group pr actices who achieve meaningful use during the 2013 and 2014 payment adjustment reporting periods.
Comment : One commenter specifically supported this proposed significant hardship exemption category. The commenter noted that es tablishing this significa nt hardship exemption category will help alleviate concerns from elig ible professionals and gr oup practices that are transitioning their EHR systems. Response : We appreciate the commenter's positiv e feedback and are finalizing this significant hardship exemption category.
Comment : One commenter took exception that th is significant hardship exemption category would only apply to those eligible pr ofessionals participati ng in the EHR Incentive Program for the first time. The commenter request ed that CMS expand the applicability of this significant hardship exemption cate gory to all eligible professiona ls who achieve meaningful use regardless of when an eligible professional first participated in the EHR Incentive Program. Response : We appreciate the commenter's feedbac k. This significant hardship exemption category was intended to be applicable to elig ible professionals and gr oup practices who achieve meaningful use during certain 2013 and 2014 eR x payment adjustment reporting periods,1093 regardless of whether it is the fi rst time the EP (or EPs in a gr oup practice) achie ves meaningful use under the EHR Incentive Program. Therefore, we clarify that this significant hardship exemption category will apply regardless of whethe r an EP has previously achieved meaningful use under the EHR Incentive Program.
Comment : Some commenters suggested that this significant hardship exemption category include EPs who have achieved meaningful use in 2011, 2012, and 2013. Response : We appreciate the commente rs’ feedback. We proposed that individual EPs or EPs within a group practice would be eligible for this significant hardship exemption category if the eligible professionals achieve meaningful use for an EHR re porting period that falls within (1) the 6-month 2013 payment adjustment reporting period (January 1 - June 30, 2012) for the 2013 payment adjustment and/or (2) the 12-month (January 1 - December 31, 2012) or 6-month (January 1 - June 30, 2013) 2014 payment adju stment reporting period for the 2014 payment adjustment. We also proposed that for th e 2013 and 2014 payment adjustments, individual EPs or EPs within a group practice would be eligible fo r this significant hardsh ip exemption category if they achieve meaningful use for an EHR re porting period that is the full CY 2012. As such, our proposal covers those EPs who achieved m eaningful use under the EHR Incentive Program in 2012 and the first 6 months of 2013. For e xpanding this significant hardship exemption category to cover EPs who have achieved meani ngful use in 2011, we understand the desire for EPs who achieved meaningful use in 2011 to be exempt from the 2013 payment adjustment. Since 2011 was the 12-month payment adjust ment reporting period for the 2013 payment adjustment, and as proposed this significant ha rdship exemption category would cover EPs who achieve meaningful use during the 12 and 6-mont h payment adjustment reporting periods for the 2014 payment adjustment, for the reasons previo usly stated for proposing this significant hardship category, we will extend this category to include individual EPs and EPs within a group1094 practice who achieve meaningful use under the EHR Incentive Program for an EHR reporting period that fell within 2011 (that is, during the 12-month 2013 payment adjustment reporting period). We cannot expand this significant hardsh ip exemption category for the 2014 payment adjustment to include eligible professionals who achieve meaningful use during the last 6 months of 2013 (July 1, 2013 - December 31, 2013) because the last 6 months of 2013 do not coincide with the 2014 payment adjustment reporting period. Based on the comments received and for the re asons previously state d, we are finalizing this significant hardship exemption category– eligible professionals or group practices who achieve meaningful use during the 2013 and 2014 payment adjustment reporting periods – as follows: To qualify for a significant hardship exemption under this category for the 2013 payment adjustment, an eligible professional (or every eligible profession al in a group practice participating in the eRx GPRO for the 2013 payment adjustment) must have achieved meaningful use of Certified EHR Technology under the EHR Incentive Program for a continuous 90-day EHR reporting period that fell within the 12-month (January 1, 2011 – December 31, 2011) or 6-month (January 1, 2012 – June 30, 2012) payment adjustment reporting period or for an EHR reporting period that is the full CY 2012. To qualify for a significant hardship exemption under this category for the 2014 paymen t adjustment, an eligible professional (or every eligible professional in a group practice par ticipating in the eRx GPRO) must achieve meaningful use of Certified EHR Technology under the EHR Incentive Program for a continuous 90-day EHR reporting period that falls within the 12-month (January 1, 2012 – December 31, 2012) or 6-month (January 1, 2013 – June 30, 2013) payment adjustment reporting period or for an EHR reporting period th at is the full CY 2012.1095 b. Eligible professionals or group practices who demonstrate intent to participate in the EHR Incentive Program and adoption of Certified EHR Technology We note that we fina lized at §414.92(c)(2)(ii)(A)( 3 ) a significant hardship exemption category for the 2012 eRx payment adjustment, under which eligible pr ofessionals and group practices seeking consideration for an exemption were required to register to participate in the EHR Incentive Program and adopt CEHRT (76 FR 54958). That significant hardship category addressed significant hardships relating to the selection, pu rchase and adoption of eRx technology (for example, potential significant financial hardship of purchasing two sets of eRx equipment for both programs) that may have occurre d as a result of the ti ming of the release of the standards and requirements for CEHRT and the Certified Health IT Product List, the establishment of the respective program require ments for the eRx and EHR Incentive Programs, and the 2012 eRx payment adjustme nt reporting periods. Given that eligible professionals have had adequate time to identify EHR products that have been certified and that the requirements for these programs have been implemented and, various stages of reporting are underway, we do not believe this significant hard ship exemption category would cont inue to be applicable for the 2013 and 2014 eRx payment adjustments. We unde rstand, however, that although an eligible professional may now have the requisite info rmation about requirements for CEHRT and each respective program, there may nevertheless exis t a significant hardship with regard to compliance with the requirements for being a successful electronic pr escriber under the eRx Incentive Program, given the nature of CEHR T and how it is used/implemented in one’s practice. When an eligible professional or eligible professional in a group practice first adopts CEHRT, we understand significant changes may be required with regard to how the eligible professional’s practice operates. Further, nece ssary steps are involved in fully implementing1096 CEHRT once it has been adopted, including: installation, configur ation, customization, training, workflow redesign and the establishment of connec tivity with entities that facilitate electronic health information exchange (such as for electronic prescriptions). Thus, we believe it would be difficult for an eligible professi onal or eligible professional in a group practice who has adopted CEHRT to be able to begin electronically prescr ibing on day one. Rather, we expect a natural lag time would likely occur betw een an eligible professional’s adoption of CEHRT and the point at which CEHRT has been fully implemented such that an eligible pr ofessional could begin electronically prescribing. We believe this implementation timeline may pose a significant hardship for an eligible professional or group practice who seeks to comply with the requirements for being a successful electronic prescriber under the eR x Incentive Program and also participate for the first time in the EH R Incentive Program. Under the EHR Incentive Program, an eligible professional who is demons trating meaningful use of CEHRT for the first time must do so for any continuous 90-day period within the calendar year (the “EHR reporting period”). In the absence of this significant ha rdship exemption category, eligible professionals or group practices who choose a 90-day EHR reporti ng period that falls later in the year may potentially have to adopt two systems (for exampl e, a stand-alone electron ic prescribing system for purposes of participati ng in the eRx Incentive Program , and CEHRT for purposes of participating in the EHR Incentive Program), which could be financially burdensome. Alternatively, such eligible professionals who wi sh to use CEHRT for purposes of participating in both programs may potentially have to adopt and implement CEHRT well in advance of their 90-day EHR reporting period to meet an earlier reporting period for the eRx Incentive Program. Therefore, for the 2013 and 2014 payment adjustments, we proposed a significant hardship exemption category to address this si tuation (77 FR 44985). We believe, however, that for this category it is necessary for eligible professionals and gr oup practices to show they intend1097 to participate in the EHR Incentive Program fo r the first time and have adopted CEHRT. Therefore, to be eligible for consideration for an exemption under this proposed significant hardship exemption category for the 2013 and 2014 payment adjustments, we proposed that eligible professionals or group prac tices must register to participat e in the Medicare or Medicaid EHR Incentive Programs and adopt CEHRT by a date specified by CMS. We further note that, given the nature of the significant hardship at issue under this category, this proposal would be limited to eligible professionals and group pr actices (that is, ever y individual eligible professional of the group practice): (1) who have not previously adopted CEHRT or received an incentive payment under the Medicare or Me dicaid EHR Incentive Programs; and (2) who attempt to participate in the Medicare or Me dicaid EHR Incentive Prog rams from January 2, 2012 through October 15, 2012, or the effective date of the final rule (w hich includes the 6- month 2013 eRx payment adjustment reporting pe riod of January 1, 2012-June 30, 2012) for the 2013 eRx payment adjustment, or during the 6-m onth payment adjustment reporting period for the 2014 eRx payment adjustment (January 1, 2013 through June 30, 2013). For eligible professionals or group practices who intend to adopt EHR technology in the future or have not yet taken th e steps required to apply for this significant hardship exemption, we believe that mere intent to adopt CEHRT or attest at a la ter date does not sufficiently demonstrate that an eligible pr ofessional will adopt CEHRT to pa rticipate in the Medicare or Medicaid EHR Incentive Programs. Unlike thos e eligible professionals who would have registered for the Medicare or Medicaid EH R Incentive Programs and have adopted CEHRT available for immediate use, we would have to monitor and provide oversi ght over those eligible professionals who have not yet taken these steps to participate in the Medicare or Medicaid EHR Incentive Programs. We also do not believe that such eligible professionals or group practices would necessarily be facing a significant hardship as contemplated in this proposed exemption1098 category. Accordingly, all of the proposed requir ements to qualify for an exemption under this significant hardship exemption category would need to be met by the time the eligible professional requests an exemption. In sect ion III.H1.5.b. below, we discuss the proposed deadlines and procedures for requesting consid eration of an exemption under this proposed significant hardship exemption category. We invited public comment on this proposed significant hardship exemption category for the 2013 and 2014 payment adjustments. The follo wing is a summary of the comments received specific to this proposed significan t hardship exemption category: eligible professionals or group practices who demonstrate intent to participate in the EHR In centive Program and adoption of Certified EHR Technology.
Comment : One commenter suggested that this si gnificant hardship ex emption category apply to eligible professiona ls who register for the EHR Incentive Program in 2011, 2012, and
2013. Response : This significant hardship exemption category does not a pply to eligible professionals who in 2011 demonstrated intent to participate in the EHR Incentive Program and adopted Certified EHR Technology. We note that this significant hardship exemption category was intended to apply to eligible professionals and group practic es dealing with i ssues related to fully implementing CEHRT once it has been adopt ed, including: instal lation, configuration, customization, training, workflow redesign and the establishment of connectivity with entities that facilitate electronic health information exch ange (such as for electronic prescriptions). We believe these eligible professi onals and group practices who a dopted CEHRT and demonstrated intent to participate in the EHR Incentive Program in 2011 would have had ample time to fully implement their CEHRT in time for the payment adjustment reporting periods for the 2013 and 2014 payment adjustments. Therefore, this si gnificant hardship exemption category does not1099 apply to eligible professionals or group practices that adopted CEHRT and demonstrated intent to participate in the EH R Incentive Program in 2011. For the 2013 payment adjustment, it was our in tent to apply this significant hardship exemption category to eligible professionals or group practices that a dopt CEHRT as well as demonstrate intent to participate in the EHR Incentive Program during a certain timeframe in 2012. We proposed that, for the 2013 payment adju stment, an eligible professional would be required to meet the qualifications for this sign ificant hardship exemption category by October 15, 2012 or the effective date of this final rule, whichever is later. For the 2014 payment adjustment, it was our in tent to apply this significant hardship exemption category to eligible professionals or group practices that a dopt CEHRT, as well as demonstrate intent to participate in the EHR Incentive Program during a certain timeframe in 2013. We proposed that an eligible professional w ould be required to meet the qualifications for this significant hardship exemption category by the end of the 6-month 2014 payment adjustment reporting period (January 1, 2013 – June 30, 2013). We established this deadline as it coincides with the deadline for requesting exemptions under the four previously established significant hardship exemption categories. Therefore, we decline to extend this significant hardship exemption category beyond June 30, 2013. Based on the comments received and for the reasons stated above, we are finalizing this significant hardship exemption category – eligible profession als or group practices who demonstrate intent to participate in the EHR Incentive Program and adoption of Certified EHR Technology. However, to provide CMS with additional time to gather information on who qualifies for a significant hardship exemption unde r this category, we ar e extending the proposed deadline. For the 2013 payment adjustment, this significant hardship ex emption category would apply to eligible professionals (or every eligible professional in a group pr actice participating in1100 the eRx GPRO) who demonstrate intent to participate in the EHR Incentive Program by registering for the program between January 2, 2012 and January 31, 2013 and adopt Certified EHR Technology. We note that eligible professi onals who achieved meaningful use of Certified EHR Technology under the EHR Incentive Program for an EHR reporting period that ended on or before June 30, 2012, or for an EHR reporting pe riod that is the full CY 2012, are not eligible for this significant hardship exemption category ( nor is a group practice pa rticipating in the eRx GPRO eligible if any of its member eligible pr ofessionals achieved meaningful use during those timeframes). For the 2014 payment adjustment, this signifi cant hardship exemption category applies to eligible professionals (or every eligible professi onal in a group practice participating in the eRx GPRO) who demonstrate intent to participate in the EHR Incentive Program by registering for the program between January 1, 2013 and June 30, 2013 and adopting Certified EHR Technology. Eligible professi onals who achieve meaningful use of Certified EHR Technology under the EHR Incentive Program for an EHR reporting period that ends on or before June 30, 2013, or for an EHR reporting period that is the full CY 2013, are not eligible for this significant hardship exemption category (nor is a group practice participating in the eRx GPRO eligible if any of its member eligible professionals achie ve meaningful use duri ng those timeframes). Please note that, should the deadline for submitti ng requests for the four previously established significant hardship exemption cat egories be extended for any reas on, it is our intent that the deadline for this significant hardship exemption category would be extended accordingly with all other significant hardship exemption cat egories to the 2014 payment adjustment. c. Deadlines and Procedures for Reque sting Significant Hardship Exemptions In the CY 2012 final rule with comment period, we established a process whereby eligible professionals would s ubmit significant hardship exempti ons for the existing significant1101 hardship exemption categories for the eRx payment adjustment s (76 FR 54963). Unfortunately, for submitting these proposed significant hardship exemptions for the 2013 payment adjustment, it would not be operationally feas ible to accept significant hardsh ip exemption requests in the manner we previously established. Therefore, we proposed that, to request a significant hardship under the two proposed significant hardship exem ption categories for the 2013 eRx payment adjustment, CMS would analyze the informa tion provided to us in the Registration and Attestation System under the EHR Incentive Pr ogram to determine whether the eligible professional or group practice (tha t is, every EP member of the group practice) has either (1) achieved meaningful use under the EHR Incentiv e Program during the applicable reporting periods we noted previously, or (2) registered to participate in the EHR Incentive Program via the Registration and Attestation system fo r the EHR Incentive Program (located at https://ehrincentives.c ms.gov/hitech/login.action ) and adopted CEHRT, or both, if applicable. We understand that providing an eligible profe ssional’s CEHRT product number is an optional field in the Registration Page. We noted that if requesting a signifi cant hardship exemption under proposed category 2, the eligible professi onal must provide its CEHRT product number when registering for the EHR Incentive Program. In the event that it is not operationally feasible to accept this information via the Registration and Attestation system for the EHR Incentive Program, we proposed that we would accept requests for significant hardship exemptions under these two proposed categories via a mailed letter to CMS to the following address: Centers for Medicare & Medicaid Services, Office of Clin ical Standards and Quality, Quality Measurement and Health Assessment Group, 7500 Security Boul evard, Mail Stop S3-02-01, Baltimore, MD
21244-1850. We also proposed that eligible professionals would be required to submit this significant hardship request by October 15, 2012 or the effective date of the final rule for this provision,1102

whichever is later. For those el igible professionals who request a significant hardship exemption based on achieving meaningful use under the EH R Incentive Program during the 12- or 6-month reporting periods for the 2013 payment adjustme nt, we also proposed that the eligible professional would be required to have attest ed under the EHR Incentive Program by October
15 th of 2012 (or if later, the effectiv e date of the final rule), to qualify for a significant hardship exemption for the 2013 payment adjustment. Fo r those eligible prof essionals requesting a significant hardship exemption for the 2013 eRx payment adjustment under the second proposed significant hardship exemption category (that is, intent to participate in the EHR Incentive Program and adoption of CEHRT), we proposed that these eligible professionals who intend to participate in the EHR Incentive Program from January 1, 2011 through October 15, 2012 or the effective date of the final rule would be require d to register for the EHR Incentive Program and adopt CEHRT by the same deadline noted above, to qualify for a significan t hardship exemption for the 2013 payment adjustment. We note that we proposed a later deadline of October 15, 2012 (or the effective date of the final rule, if later) for the submission of these requests because the deadline for submitting request s under other previously establ ished significant hardship exemption categories to the 2013 eRx payment ad justment (June 30, 2012) has passed and other similar dates we might choose would likely have pa ssed by the time the final rule is effective. For submitting exemption requests for the two significant hardship exemption categories for the 2014 payment adjustment, we proposed the following method for submitting a request for a significant hardship exemption: Via the Co mmunication Support Page (which is the method established for submitting the established significant hardship exemption categories). In addition, we considered accepting significan t hardship exemption requests for the two proposed significant hardship exemption cate gories for the 2014 payment adjustment by CMS receiving eligible professionals' information th rough the Registration and Attestation System for1103 the EHR Incentive Program (similar to our pr oposed submission process for the 2013 payment adjustment) and via a mailed letter to CMS using the following a ddress: Centers for Medicare & Medicaid Services, Office of Clinical Standards and Quality, Quality Measurement and Health Assessment Group, 7500 Security Boulevard, Mail Stop S3-02-01, Baltimore, MD 21244-1850. We invited public comment on these considered submission options. We proposed that the deadline for subm itting these significant hardship exemption requests for the 2014 payment adjustment would be June 30, 2013, which is the same deadline established for submitting a significant hardship exemption request for the existing significant hardship exemption categories. Additionally, and consistent with our proposal for the 2013 payment adjustment, we proposed that an eligib le professional or gr oup practice (that is, all members of the practice) that achieves mean ingful use under the EHR Incentive Program during the 6- or 12-month reporting periods for the 2014 payment adjustment would be required to attest by June 30, 2013. Similarly, for eligible professionals requesting a significant hardship exemption for the 2014 payment adjustment unde r the second proposed significant hardship exemption category (that is, intent to participate in the EHR In centive Program and adoption of CEHRT), we proposed that eligible professionals who intend to participate in the EHR Incentive Program during the last 6 months of 2013 would be required to register for the EHR Incentive Program and adopt CEHRT by June 30, 2013, to qualif y for a significant hardship exemption for the 2014 payment adjustment. We noted that we understood that these deadlines may exclude some eligible professionals who attested or registered for th e EHR Incentive Program at later dates, but these deadlines were necessary to avoid the reprocessing of claims. We note, however, that these proposed deadlines would not extend any deadlines applicable under the EHR Incentive Program. That is, for purposes of the EHR Incentive Program, an eligible professional would still be requi red to attest to being a mean ingful user by the deadline1104 established under the EHR Incentive Program, even if such deadline fell prior to the proposed eRx Incentive program significant ha rdship exemption deadline. We noted that we only proposed submi ssion of requests for significant hardship exemptions under these two categories under an individual eligible pr ofessional level only because it is not technically feasible for us to operationally analyze information on the EHR Incentive Program’s Registration and Attestation pa ge using the TIN, as the information stored in this system is stored by NPI. However, we stated we would not preclude eligible professionals in an eRx GPRO for 2012 from submitting requests for significant hardship exemptions under these two categories. Theref ore, to allow the submission of significant hardship requests for the 2013 eRx payment adju stment under these two proposed categories, we proposed that eligible professionals within an eRx GPRO must each request a significant hardship exemption under th ese two categories. We invited public comment on this proposed process for submitting significant hardship exemption requests under these two proposed categories. The following is a summary of the comments received related to these proposals.
Comment : Several commenters requested that CM S utilize information contained in the EHR Incentive Program's Registration and Attest ation page to determine who would qualify for the two additional significan t hardship exemption categories for the 2013 and 2014 payment adjustment. Another commenter recommended th at the process for requesting a significant hardship exemption under these tw o categories be streamlined. One commenter requested that CMS provide as many options as possible for el igible professionals to submit requests for significant hardship exemptions under the two proposed categories. One commenter suggested that requests be submitted electronically, not via U. S. mail. Overall, most commenters believe that using information already collected by CM S from the EHR Incentive Program's Registration1105 and Attestation page to exempt eligible professionals from the 2013 and 2014 payment adjustment would reduce burden on eligible professionals and group practices as they would not be required to actively request a signi ficant hardship exemption via the web. Response : We agree that basing applicability of these two significant hardship exemption categories on information collected from the EHR Incentive Program 's Registration and Attestation page for the 2013 and 2014 payment ad justments would reliev e burden on eligible professionals as they would not be required to actively request a significant hardship exemption via the web. Based on the comments received, we are finalizing our proposal to use information collected from the EHR Incentive Program's registra tion and attestation page to exempt eligible professionals from the 2013 payment adjustment unde r these two additional significant hardship exemption categories. In addition, based on the comments received, we will use this same method to exempt eligible professionals from the 2014 payment adjustment under these two additional significant hardship exemption categorie s rather than requiring eligible professionals to request exemptions under these two significan t hardship exemption categories via the web. We are not finalizing any other options for reque sting an exemption under these two categories, because we believe that this method is the most efficient way to exempt eligible professionals. We note that we are able to internally analyze th is data for the two additional significant hardship exemption categories, and not the other previ ously established four significant hardship exemption categories, because, unl ike the previous four categories, CMS already has access to the information needed under the EHR Incentive Pr ogram's Registration and Attestation page to make our determination on whether an eligible professional should be exempt from the 2013 and/or 2014 payment adjustments under these two significant hardship exemption categories.
Comment : Some commenters requested that CMS extend the proposed deadline to submit requests for significant hardship exempti ons under these two additi onal categories. One1106 commenter requested that eligible professionals and group practices be allowed at least 90 days to submit such a request. Other commenters suggested a deadline of October 31, 2012 to apply exemptions under these two proposed significan t hardship exemptions for the 2013 payment adjustment. In addition, since the proposed d eadlines for qualifying for these two additional significant hardship exemption categories are late r than the established deadline for the four previously established significant hardship exem ption categories, the commenter requested that the deadline for requesting exemptions under the four previously established significant hardship exemption categories be extended to coincide with the established deadline for these two additional significant hardship categories. Response : For applying these two proposed signifi cant hardship exemptions for the 2013 payment adjustment, we proposed a deadline of October 15, 2012 or the ef fective date of the rule, whichever is later. Since our proposed deadline date of Octobe r 15, 2012 as well as the commenter's proposed deadline date of Octobe r 31, 2012 has passed, we considered finalizing our proposed deadline of the effective date of the CY 2013 Medicare PFS final rule. However, it is our understanding that certain eligible professionals that ac hieve meaningful use may have until February 28 of the following year to attest that they me t the CQM component of achieving meaningful use. Although it is not practically feasible to extend the deadline for qualifying for the first significant hardship exemption categor y (related to achieving meaningful use under the EHR Incentive Program) due to the need to minimi ze the reprocessing of claims, it is feasible to extend the deadline for qualifying for this significa nt hardship exemption category to January 31, 2013. To afford eligible professionals with mo re time to qualify for this exemption, we are therefore finalizing a deadline of January 31, 201 3 to qualify for this significant hardship exemption category related to achieving meaningf ul use under the EHR Incentive Program. So that the deadlines for qualifying for these two additional significant hardship exemptions1107 coincide, we are also finalizing a deadline of January 31, 2013 to qualify for the second significant hardship exemption cate gory related to demonstrating inte nt to participate in the EHR Incentive Program. Therefore, for the 2013 paym ent adjustment, eligible professionals must qualify for consideration under thes e two additional sign ificant hardship exemption categories by January 31, 2013. We received no public comment regarding th e proposed deadline for qualifying for an exemption under these two additional significant hardship exemption categories for the 2014 payment adjustment. Based on the reasons stated previously, we are fina lizing this proposal. We note, however, that in the event that the deadlines for requesting a significant hardship exemption under the four previously established exemption categories are extended, we intend to extend this deadline to coincide with the deadline for re questing exemptions under these other four categories. Additionally, we may exte nd this deadline should we run into operational concerns, such as receiving data from the EHR Incentive Program’s Registration and Attestation
page. With respect to extending the deadline to submit exemption requests under the four previously established significant hardship exemption categories for the 2013 payment adjustment, we will allow the extension of the deadline to request exemptions under these four previously established exemption categories to January 31, 2013. We finalized a deadline of June 30, 2012 to submit requests for exemptions unde r these four significant hardship categories primarily to avoid having to reprocess claims. Since we are extending th is deadline to January 31, 2013, we anticipate that, in some cases, particul arly in instances where eligible professionals submit significant hardship exemption requests clos er towards the deadline, we may not be able to complete our review of the requests before the claims processing systems updates are made to begin reducing eligible professionals’ and gr oup practices’ PFS amounts in 2013. In such cases,1108 if we ultimately approve the el igible professional or group pract ice’s request for a significant hardship exemption after January 1, 2013, we woul d need to reprocess all claims for services furnished up to that point in 2013 that were paid at the reduced PFS amount, which we anticipate may take several months. To avoid the repr ocessing of claims, we encourage eligible professionals who would be submitting a significant hardship exemption request under these four significant hardship exemption cate gories to do so as soon as possibl e, rather than waiting until the deadline to submit such a request. We note that we would like to be able to process all such requests before we begin making the claims processing systems changes to adjust eligible pr ofessionals’ or group practices’ payments starting on January 1, 2013 or 2014. However, we anticipate that, in some cases, particularly in instances where eligib le professionals submit significant hardship exemption requests closer towards the deadline, we may not be able to complete our review of the requests before the claims processing syst ems updates are made to begin reducing eligible professionals’ and group practices’ PFS amounts in 2013. In such cases, if we ultimately approve the eligible professional or gr oup practice’s request for a signif icant hardship exemption after January 1, 2013 or 2014, we would need to reprocess all claims for services furnished up to that point in 2013 that were paid at the reduced PFS amount, which we anticipate may take several months. To avoid the reprocessing of claims, we encourage eligible prof essionals who would be submitting a significant hardship exemption reques t under these two categories to do so as soon as possible, rather than waiting until the deadline to submit such a request. Tables 125 and 126 provide a summary of the significant hardship exemption categories that are available to eligible professionals and group practices for the 2013 and 2014 payment adjustments. Table 125: Summary of Significant Hardsh ip Exemption Categories for the 2013 eRx Payment Adjustment1109

Significant Hardship Exemption Category Method of Submission Deadline for Submitting Exemption Request The eligible professional or group practice practices in a rural area with limited high speed internet access Web-based Communication Support Page Extended to January 31, 2013 The eligible professional or group practice practices in an area with limited available pharmacies for electronic prescribing Web-based Communication Support Page Extended to January 31, 2013

The eligible professional or group practice is unable to electronically prescribe due to local, state, or Federal law or regulation Web-based Communication Support Page Extended to January 31, 2013

The eligible professional or group practice has limited prescribing activity, as defined by an eligible professional generating fewer than 100 prescriptions during a 6-month reporting period Web-based Communication Support Page Extended to January 31, 2013

* Eligible professionals or group practices who achieve meaningful use during the 2013 12- and 6- month eRx payment adjustment reporting periods (that is, January 1, 2011 – June 30, 2012) EHR Incentive Program’s Registration and Attestation Page January 31, 2013

* Eligible professionals or group practices who demonstrate intent to participate in the EHR Incentive Program and adoption of Certified EHR Technology EHR Incentive Program’s Registration and Attestation Page January 31, 2013

* Eligible professionals participating in the eRx Incen tive Program under the eRx GP RO are eligible for these significant hardship exemption categories. However, each eligible professional in the eRx GPRO wishing to have this exemption applied must individually have provided the requisite information on the EHR Incentive Program’s Registration and Attestation page. Table 126: Summary of Significant Hardsh ip Exemption Categories for the 2014 eRx Payment Adjustment Significant Hardship Exemption Category Method of Submission Deadline for Submitting Exemption Request The eligible professional or group practice practices in a rural area with limited high speed internet access Web-based Communication Support Page June 30, 2013

The eligible professional or group practice practices in an area with limited available pharmacies for electronic prescribing Web-based Communication Support Page June 30, 20131110
Significant Hardship Exemption Category Method of Submission Deadline for Submitting Exemption Request The eligible professional or group practice is unable to electronically prescribe due to local, state, or Federal law or regulation Web-based Communication Support Page June 30, 2013

The eligible professional or group practice has limited prescribing activity, as defined by an eligible professional generating fewer than 100 prescriptions during a 6-month reporting period Web-based Communication Support Page June 30, 2013

* Eligible professionals or group practices who achieve meaningful use during the 2014 12- and 6- month eRx payment adjustment reporting periods (that is, January 1, 2012 – June 30, 2013) EHR Incentive Program’s Registration and Attestation Page June 30, 2013

* Eligible professionals or group practices who demonstrate intent to participate in the EHR Incentive Program and adoption of Certified EHR Technology EHR Incentive Program’s Registration and Attestation Page June 30, 2013

* Eligible professionals participating in the eRx Incen tive Program under the eRx GP RO are eligible for these significant hardship exemption categories. However, each eligible professional in the eRx GPRO wishing to have this exemption applied must individually have provided the requisite information on the EHR Incentive Program’s Registration and Attestation page.

6. Informal Review To better facilitate issu es surrounding the issuance of incentives and payment adjustments, we proposed to establish an inform al review process for the eRx Incentive Program (77 FR 44987). We proposed an informal review process similar to the informal review process established for the PQRS (76 FR 73390), because eligible professionals and group practices are already familiar with this process. We proposed the informal review process would only be available for the 2013 incentive payments and the 2014 payment adjustment. For an informal review regarding the 2013 incentive, we proposed that an eligible professional or group practice must request an informal review with in 90 days of the release of his or her feedback report, i rrespective of when an eligible professional or group practice1111 actually accesses his/her feedback report. For an informal review regarding the 2014 payment adjustment, we proposed that an eligible professional or group pr actice must request an informal review by January 31, 2013 (77 FR 44988). We believed this deadline would prov ide ample time for eligible professionals and group practices to discover that their respectiv e claims are being adjusted due to the 2014 payment adjustment and seek informal review. We proposed that the request be submitted in writing and summarize the concern(s) and reasons for requesting an informal review. In his or her request for an informal review, an eligible professional may also submit other informa tion to assist in the re view. We proposed that an eligible professional may request an informal review through the web. We believe use of the web would provide a more efficient way for CMS to record informal review requests, as the web would guide the eligible professional through the creation of an informal review requests. For example, the web-based tool would prompt an e ligible professional of a ny necessary information he or she must provide. Should it be technically not feasible to receiv e requests for informal reviews via the web, we proposed that an eligible professional would be able to request an informal review via email (77 FR 44988). We further proposed that we would make our determination and provide the eligible professional or group practice with a written response to his or her request for an informal review within 90 days of receiving the request. Based on our informal review and once we ha ve made a determination, we proposed that we would provide the eligible pr ofessional or group practice a written response. Where we find that the eligible professional or group practice did successfully report for the 2013 incentive, we would provide the eligible professi onal or group practice with the applicable incentive payment. Where we find that the eligible professional or group practice did successf ully report (that is,1112 meet criteria for being a successful electroni c prescriber) for purpos es of the 2014 payment adjustment, we would cease application of the 2014 payment adjustment and reprocess all claims that have been adjusted. We further proposed th at decisions based on the informal review would be final, and there would be no further review or appeal. We invited public comment on our proposal s for the eRx Incentiv e Program informal review process for the 2013 incentive and the 2014 payment adjustment. The following is a summary of comments we received on these proposals:
Comment : Several commenters supported our proposal to establish an informal review process for the 2013 incentive and 2014 payment adjustment. Response : We appreciate the commenters' feedb ack and are finalizi ng our proposal to establish an informal review process for the 2013 incentive and 2014 payment adjustment.
Comment : One commenter urged CMS to create a more formal appeals process that provides eligible professionals with concurrent feedback on reporting. Response : We appreciate the commenter's feedbac k. We note that the informal review process we have proposed has deadlines and a pro cess similar to formal review processes. We believe the informal review process we are estab lishing is appropriate for this program and is an adequate venue for eligible professionals and group practices to seek a review of their eRx incentive or payment adjustment applicability. W ith respect to providing concurrent feedback on reporting, for the 2012 and 2013 incentives, feedback reports will be available to eligible professionals and group pract ices prior to the start of the informal review process. With respect to the 2013 and 2014 payment adjustments, with respect to reporting during the 12-month 2013 and 2014 payment adjustment reporting periods (that is, January 1, 2011 – December 31, 2011 and January 1, 2012 – December 31, 2012 respectively) , we note that these feedback reports, which are the same feedback reports given fo r the 2011 and 2012 incentives respectively, will be1113 provided prior to the start of the informal revi ew process. While it may not be technically feasible to have feedback reports for the 6-month 2013 and 2014 payment adjustment reporting periods (that is, January 1, 2012—June 30, 2012 and January 1, 2013—June 30, 2013 respectively), we note that we anticipate that payment adjustment status notifications to eligible professionals who report the electronic prescribin g measure will be made available prior to the start of the informal review process.
Comment : One commenter urged that we align the PQRS and eRx informal review
processes. Response : To the extent possible, it is our in tention to align the informal review processes for the eRx Incentive Program and PQ RS. We established the same deadline for requesting an informal review under the eRx Incentive Program and PQRS. However, we stress that these two programs are separa te and require separate methods of review. For example, the eRx Incentive Program involves the reporting of one measure, whereas PQRS involves the reporting of hundreds of measures. Therefore, th e PQRS informal review process would require more intensive resources than the eRx Incen tive Program's informal review process.
Comment : In addition to supporting our proposal to establish an informal review process for the 2013 eRx incentive and 2014 eRx payment adjustment, some commenters urged us to establish a similar informal review process for the 2012 eRx incentive and 2012 and 2013 eRx payment adjustments. The commenters believed that extending this informal review process would allow eligible professionals or group practi ces who have had administrative, operational, or technological issues to present their case to CMS. Response : We understand the desire to establish a similar informal review process for the 2012 eRx incentive and 2012 and 2013 eRx payment ad justments. As for establishing an informal review process for the 2012 eRx paymen t adjustment, we note that we have already1114 reviewed cases where an eligible professional or group practice has sough t a review of their 2012 eRx payment adjustment applicabil ity. We also note that it is not operationally feasible to establish an informal review process for the 2012 eRx payment adjustment until 2013, after the cessation of the application of the 2012 eRx paymen t adjustment for eligible professionals who were not successful electronic prescribers. Howe ver, we believe it will be operationally feasible to establish an informal review process fo r the 2012 eRx incentiv e and 2013 eRx payment adjustment. Therefore, we are finalizing an informal review process for the 2012 and 2013 eRx incentives and 2013 and 2014 eRx payment adjustme nts. The process and deadlines for the informal review process for the 2012 eRx in centive and 2013 eRx payment adjustment will mirror our established process and deadlines for the 2013 eRx incentive and 2014 eRx payment adjustment.
Comment : Some commenters recommended that e ligible professionals be given until March 31, 2014 to request an informal review relating to issues surrounding the 2012 and 2013 eRx incentives and 2012, 2013 and 2014 eRx payment adjustments. The commenters noted that eligible professionals and group practices need ample time to keep up with informal review deadlines that vary from program to program. Response : We understand the need to provide elig ible professionals with ample time to learn about the informal review process. However, it is not operationally f easible to establish an informal review request deadline of March 31, 2014 for the 2012 and 2013 eRx incentives and 2012, 2013, and 2014 eRx payment adjustments. This would be overly burdensome and costly for CMS, as CMS would then have to potenti ally process claims from 2012—2014 for those who receive a favorable decision. To minimize the reprocessing of claims, the informal review process (which includes the time for submitting a request as well as the processing time to review these requests) would need to occur with in the year the eligible professional or group1115 practice’s payments are being adjusted (for ex ample, in 2013 for the 2013 payment adjustment). However, we believe it is feasible to extend th e deadline for requesting an informal review past January 31. Therefore, we are fi nalizing a deadline of February 28, 2013 to request an informal review related to issues surrounding the 2012 eR x incentive and 2013 eRx payment adjustment. We are finalizing a deadline of February 28, 2014 to request an informal review related to issues surrounding the 2013 eRx incentive and 2014 eRx pa yment adjustment. Please note that February 28 is the same deadline we establishe d for the PQRS payment adjustment informal review process, thereby alleviating the issue of eligible professiona ls and group practices needing to keep up with different in formal review request deadlines.
Comment : Some commenters supported our proposal to receive informal review requests via the web. Response : We appreciate the commenter's feedbac k. Unfortunately, it is not technically feasible for us to accept informal review requests via an online t ool. However, we believe that accepting informal review requests electronically will be the most efficient way to facilitate the informal review process as opposed to receivi ng mailed requests. Therefore, we will accept informal review requests via an email to CMS. To summarize what we have finalized, we are establishing an informal review process for the 2012 and 2013 eRx incentives and 2013 and 2014 eRx payment adjustments. As such, we are also finalizing our proposed modifications to §414.92 that address the informal review process we are establishing. Eligible professiona ls and group practices wishing to request an informal review must do so via email. Fo r the 2012 eRx incentive and 2013 eRx incentives, eligible professionals and group pr actices must submit a request for an informal review 90 days after the receipt of the resp ective feedback reports. Fo r the 2013 and 2014 eRx payment adjustments, eligible professionals and group pr actices must submit a request for an informal1116 review by February 28, 2013 and February 28, 2014, respectively. CMS will provide a written response to each informal review request. More information regarding this informal review process will be available on the eR x Incentive Program’s website at http://www.cms.gov/Medicare/Quality -Initiatives-Patient-AssessmentInstruments/ERxIncentive/inde x.html?redirect=/ERXincentive

. H2. The PQRS-Medicare EHR Incentive Pilot The Medicare EHR Incentive Program pr ovides incentive payments to eligible professionals (EPs) who demonstrate meaningful use of certified EHR technology (CEHRT). EPs who fail to demonstrate meaningful use will be subject to payment adjustments beginning in 2015. We established a phased approach to meaningf ul use, which we exp ect will include three stages (77 FR 53973), and all EPs are currently in Stage 1. In the CY 2012 Medicare PFS final rule, we established the PQRS-Med icare EHR Incentive Pilot in an effort to pilot the electronic submission of CQMs for the Medicare EHR Incen tive Program and move towards the alignment of quality reporting requirements between Stage 1 of the Medicare EHR Incentive Program and the PQRS (76 FR 73422). We refer readers to th e final rule for further explanation of the requirements of the Pilot (76 FR 73422 – 73425). Specifically, we established that an EP participating in the PQRS-Medicare EHR Incentive Pilot would be able to report clinical quality measures (CQMs) data extracted from Certifie d EHR Technology via use of a PQRS qualified direct EHR product or PQRS qualified EHR data submission vendor (76 FR 73422). We proposed to modify §495.8 to extend this Pilo t for CY 2013 as it was finalized for CY 2012. We also proposed to remove from §495.8(a)(2)(v) the cr oss-reference to §495.6(d)(10) to conform to the proposed changes to §495.6(d) that were incl uded in the EHR Incentive Program – Stage 2 NPRM (77 FR 53976). This proposal includes the following:

● For 2013 only, EPs intending to particip ate in the PQRS-Medicare EHR Incentive1117 Pilot may use a PQRS qualified EHR data s ubmission vendor that would submit CQM data extracted from the EP’s CEHRT to CMS. Under this option, identical to the submission process used for the Pilot in 2012, the PQRS qualified EHR data submi ssion vendor would calculate the CQMs from the EP’s CEHRT and then submit the calculated results to CMS on the EP’s behalf via a secure portal for purposes of this Pilot.

● For 2013 only, identical to the submissi on process used for the Pilot in 2012, EPs intending to participate in the PQRS-Medicar e EHR Incentive Pilot may use a PQRS qualified direct EHR product to submit CQM data directly from his or he r CEHRT to CMS via a secure portal using the infrastructure of the PQRS EHR-based reporting mechanism. In addition, for 2013, we proposed to extend th e use of attestation as a reporting method for the CQM component of meaningful use for the EHR Incentive Program. For 2013, EPs would be able to continue to report by attes ting CQM results as calcula ted by CEHRT, as they did for 2011 and 2012. For further explanation of the CQM reporting criteria for EPs and reporting by attestation, we refe r readers to the EHR Incentive Program – Stage 2 final rule (77 FR 54049 through 54089) and the EHR Incentive Progr am – Stage 1 final rule (75 FR 44386 – 44411, 44430 – 44434). We invited public comment on our proposal to extend to 2013 the PQRS-Medicare EHR Incentive Pilot as it was established for 2012 as well as reporting CQ Ms by attestation. The following is a summary of the comments we received regarding our proposals.
Comment : Several commenters supported our proposal to extend the PQRS-Medicare EHR Incentive Pilot to 2013. The commenter s do not believe that there was sufficient participation in 2012 to move be yond the Pilot stage in 2013. Th e commenters noted that the extension of the Pilot will con tinue to encourage the adoption of health information technology (HIT).1118
Response : We appreciate the commenters’ feedb ack and agree with the commenters. Based on the comments received and for the reas ons previously stated, we are finalizing our proposal to extend the PQRS-Medicare EHR Ince ntive Pilot to CY 2013 as proposed. We are also finalizing our proposal to extend the use of attestation to CY 2013 as a reporting method for the CQM component of meaningful use for the EHR Incentive Program. We are also finalizing our proposed revisions to § 495.8 as proposed. Pl ease note we are only extending the Pilot for 2013 because in the EHR Incentive Program – Stage 2 final rule (77 FR 53968), we established a policy that will require all EPs participating in the Medicare EHR Incentive Program that are beyond their first year of meaningful use to electronically submit CQM data. I. Medicare Shared Savings Program 1. Medicare Shared Savings Program and Physician Quality Reporting System Payment Adjustment Under section 1899 of the Act, CMS has esta blished a Medicare Shared Savings Program (Shared Savings Program) to facilitate coordina tion and cooperation among providers to improve the quality of care for Medicare Fee-For-Servi ce (FFS) beneficiaries a nd reduce the rate of growth in healthcare costs. Eligible groups of providers a nd suppliers, including physicians, hospitals, and other healthcare providers, may pa rticipate in the Shar ed Savings Program by forming or participating in an Accountable Care Organization (ACO). The final rule implementing the Shared Savings Program appeared in the Federal Register on November 2, 2011 (Medicare Shared Savings Program: Accountab le Care Organizations Final Rule (76 FR 67802)). Section 1899(b)(3)(D) of the Act affords the Secretary discretion to “* * * incorporate reporting requirements and incentive payments related to the physician quality reporting initiative (PQRI), under section 1848 of the Act, including such requirements and such payments1119 related to electronic prescribing, electronic health records, a nd other similar initiatives under section 1848 * * *” and permits the Secretary to “use alternative criteri a than would otherwise apply [under section 1848 of the Act] for determin ing whether to make such payments.” Under this authority, we incorporated certain Physic ian Quality Reporting System (PQRS) reporting requirements and incentive payments into the Shared Savings Program (76 FR 67902). In the Shared Savings Program final rule, we finalized the following requirements with regard to PQRS incentive payments under the Shared Savings Pr ogram: (1) the 22 GPRO quality measures identified in Table 1 of the final rule (76 FR 67889-67890); (2) reporting via the GPRO web interface (76 FR 67893); (3) criteria for satisf actory reporting (76 FR 67900); and (4) January 1 through December 31 as the reporting period. The regulation governing the incorporation of PQRS incentives and reporting requirements under the Shared Savings Program is set forth at §425.504. Under §425.504(a)(1), ACOs, on behalf of their ACO provider/suppliers who are eligible professionals, must submit the measures determined under §425.500 using the GPRO web interface established by CMS, to qualify on behalf of their eligible professionals for the PQRS incentive under the Shared Savings Program. ACO providers/suppliers that are eligible professionals constitute a group practice for purp oses of qualifying for a PQRS incentive under the Shared Savings Program. Under §425.504(a) (2)(ii), an ACO, on behalf of its ACO providers/suppliers who are elig ible professionals, must satisf actorily report the measures determined under the Shared Savings Program during the reporting period according to the method of submission established by CMS to receive a PQRS incentive under the Shared Savings Program. For the years in which a PQRS incentive is available, if eligible professionals that participate in an ACO as ACO providers/s uppliers qualify for a PQRS incentive payment under the Medicare Shared Savings Program, th e ACO participant TIN(s) under which those1120 ACO providers/suppliers bill, will receive an ince ntive payment based on the allowed charges of those ACO providers/suppliers. Under §425.504(a )(4), ACO participant TINs and individual ACO providers/suppliers who are eligible profe ssionals cannot earn a PQRS incentive outside of the Medicare Shared Savings Program. The PQRS incentive under the Medi care Shared Savings Program is equal to 0.5 percent of the Secretary’ s estimate of the ACO’s eligible professionals’ total Medicare Part B PFS allowed charges for covered professional serv ices furnished during the calendar year reporting period from January 1 through December 31, for years 2012 through
2014. As discussed in section III.G of this fina l rule with comment period, as required by section 1848(a)(8) of the Act, a payment adju stment will apply under the PQRS beginning in 2015. For eligible professionals who are not sa tisfactory reporters, the PFS amount for covered professional services furnished by the eligible professional during 2015 shall be equal to 98.5 percent (and 98 percent for 2016 and each subsequent year) of the fee schedule amount that would otherwise apply to such services. Therefor e, consistent with our authority under section 1899(b)(3)(D) of the Act, we proposed to am end §425.504 to incorporate reporting requirements for the PQRS payment adjustment under the Shared Savings Program for eligible professionals that are ACO providers/suppliers (77 FR 44989). We proposed to incorporate requirements fo r the PQRS payment adjustment that are consistent with requirements for PQRS incentives that we previously adopted in the Shared Savings Program final rule. Specifically, for pu rposes of the PQRS payment adjustment, we proposed to incorporate the same PQRS GPRO under the Shared Savings Program that is currently used for purposes of the PQRS incen tive under the Shared Savings Program. Under this proposal, eligible profe ssionals that are ACO providers/s uppliers would constitute a group practice that would repor t quality measures via the GPRO da ta collection tool for purposes of1121
both the PQRS incentive under the Shared Savings Program and the PQRS payment adjustment under the Shared Savings Program (77 FR 44989). For purposes of the payment adjustment, we proposed to use the final GPRO quality measures adopted under the Shared Shavings Prog ram that appear in Table 1 of the Shared Savings Program final rule ( 76 FR 67899-67890). We further proposed to incorporate the same criteria for satisfactory reporti ng that were finalized for the PQRS incentive under the Shared Savings Program, which are described in the Sh ared Savings Program final rule (76 FR 67900). Specifically:

● An ACO on behalf of its eligible professi onals must report on all measures included in the GPRO data collection tool under the Shared Savings Program final rule.

● Beneficiaries would be assigned to the ACO using the methodology described in §425.400. As a result, the GPRO tool would be populated based on a sample of the ACOassigned beneficiary population. ACOs must complete the tool for the first 411 consecutively ranked and assigned beneficiaries in the order in which they appear in the group’s sample for each domain, measures set, or individual measure if a separate denominator is required such as in the case of preventive care measures which may be specific to one sex. If the pool of eligible assigned beneficiaries is less than 411, the ACO must repor t on 100 percent of assigned beneficiaries for the domain, measur es set, or individual measure.

● The GPRO data collection tool must be completed for all domains, measure sets and measures described in Table 1 of the of the Shared Savings Program final rule (76 FR 67889- 67890). Under this proposal, ACOs would need to satisfactorily report the 22 GPRO quality measures identified in Table 1 of the Shared Savings Program final rule (76 FR 67889-67890) and would not need to report the other 11 Shared Savings Program quality performance measures1122 for purposes of satisfactory reporting for the PQ RS payment adjustment. However, under this proposal, the ACO would still be required to satisfy the ACO quality performance standards for purposes of determining elig ibility for shared savings, as described in §425.502. We note that the proposal that ACOs repor t the same quality measures for purposes of satisfactory reporting for both the PQRS paymen t adjustment and incentive payments under the Shared Savings Program was consistent with the proposal under the tr aditional PQRS GPRO Web Interface reporting option that the criteria for satisfactory reporting for the payment adjustments align with the sati sfactory reporting requirements for the incentive payments (77 FR 44824).
Comment: We received a number of comments suppor ting the proposal to incorporate the same PQRS GPRO measures us ed for the PQRS incentive payment under the Shared Savings Program and Shared Savings Program quality perfor mance standards. We also received support for accepting quality data at the ACO level rath er than requiring each ACO provider and supplier who is an eligible professional to submit meas ure data separately to PQRS outside of the Medicare Shared Savings Program. We did not receive any comments opposing our proposal or suggesting alternatives. Response: We appreciate commenters’ support and are finalizing our proposal to use the final GPRO quality measures adopt ed under the Shared Shavings Pr ogram that appear in Table 1 of the Shared Savings Program final rule (76 FR 67899-67890) for purposes of the PQRS payment adjustment satisfactory re porting criteria with the follo wing modifications. Instead of requiring ACOs to report on all of the ACO GPRO quality measures for purposes of satisfactory reporting for the 2015 PQRS payment adjustment under the Shared Savings Program, ACOs must only report one of the ACO GPRO measures that were finalized for the PQRS incentive under the Shared Savings Program, as described a bove and in the Shared Savings Program final1123 rule (76 FR 67900). As the intent of our proposal was to align with the traditional PQRS GPRO Web Interface reporting option pol icy regarding the PQRS payment adjustment, this policy for ACOs participating in PQRS under the Shared Savings Program, as finalized under §425.504(b), is consistent with the criteria for satisfactory re porting that we are fina lizing for group practices that select the PQRS GPRO Web Interface repo rting option, for the 2015 payment adjustment, as discussed in section III.G. of this final rule. We believe that aligning the satisfactory reporting requirements for the 2015 PQRS payment adju stment under the Medicare Shared Savings Program with the satisfactory reporting require ments for the payment adjustment under the traditional PQRS GPRO Web Interface repor ting option is important for encouraging participation in the Medicare Shared Savings Pr ogram. That is, we do not wish to create a disincentive for eligible professionals to join an ACO or participate in the Medicare Shared Savings Program by setting the satisfactory re porting criteria for the 2015 PQRS payment adjustment at a higher level under the Medica re Shared Savings Program than under the traditional PQRS. We believe it is appropriate to set the satisfactory reporting criteria higher for purposes of the PQRS incentive than for the PQRS payment adjustment, under the Shared Savings Program, for the same reasons discus sed in section III.G. of this final rule. While satisfactorily reporti ng one measure would be requi red for purposes of avoiding the 2015 PQRS payment adjustment under the Medi care Shared Savings Program, we note that ACOs are still required to repor t all 22 GPRO measures for pu rposes of the PQRS incentive under the Shared Savings Program and for purpos es of assessing ACOs’ quality performance under the Shared Savings Program and determining the percentage of shared savings that ACOs are eligible to receive. In addition, under the Shared Sa vings Program regulations at §425.500(e)(3), ACOs are required to report on all of the quality measures established by CMS, and the failure to report on those quality measures accurately, completely, and timely may1124 subject the ACO to termination or other sancti ons. Therefore, we expect PQRS eligible professionals who are ACO provide rs/suppliers to meet the satisfa ctory reporting criteria for the 2015 PQRS payment adjustment, since they would need to continue to report beyond the one measure for purposes of the PQRS incentive pa yment and Shared Savings Program shared savings. Satisfactory reporting criteria for the PQRS payment adjustment under the Shared Savings Program for 2016 and beyond will be discussed in future rulemaking. Although we proposed to use the same timeframe of January 1 through December 31 that we adopted for the PQRS incentive under the Shar ed Savings Program as the reporting period for the PQRS payment adjustment, we proposed that the timing of the reporting period would differ for purposes of the PQRS payment adjustment (77 FR 44990). Specifically, we proposed that the reporting period for the paym ent adjustment would fall 2 year s prior to when the payment adjustment would be assessed. For example, under the Shared Savings Program, the reporting period for the 2015 payment adjustment would be from January 1, 2013 through December 31,
2013. We also noted that this policy results in overlapping reporting peri ods for both the PQRS incentive and payment adjustment. For exampl e, the measure data collected for the 2013 calendar year reporting period (January 1, 2013-D ecember 31, 2013) would be used for purposes of both the Physician Quality Reporting Syst em 2013 incentive and 2015 payment adjustment under the Shared Savings Program. We believed that using the same reporting period for purposes of both the incentive and payment adjust ment would result in less reporting burden and that ACOs would perceive this as more effici ent than requiring one se t of measures reported during one timeframe for purposes of the PQ RS incentive and another set during another timeframe for purposes of the payment adjustment.
Comments: We received several comments in support of the reporting period proposed1125 for assessing the PQRS payment adjustment under the Shared Savings Program. Some of these commenters supported the proposal, because it ali gned with the same reporting period proposed for group practices participating in the PQRS GPRO. We did not receive any comments opposing this proposal or sugge sting alternatives. Response: We appreciate the commenters’ suppor t and are finalizing our proposal that the reporting period for the pa yment adjustment fall 2 years prior to when the payment adjustment is assessed. For example, under the Shared Savings Program, the reporting period for the 2015 payment adjustment is from January 1, 2013 through December 31, 2013. It is necessary for us to use a reporting period that precedes the year in which the payment adjustment is applicable to avoid retroactive payments and the reprocessing of claims. In addition, it is not opera tionally feasible for us to use a fu ll calendar year reporting period that falls closer to the year in which the payment adju stment is applicable because we need sufficient time to determine if the requirements for satisfact ory reporting have been met and to adjust our claims systems prior to the start of the applicable year. We note that th e length and timing of the reporting period that we are fi nalizing for the PQRS payment adjustment under the Shared Savings Program is consistent with the one fina lized for the traditional PQRS (76 FR 73392). Since the publication of the Shared Savi ngs Program final rule, we have received a number of inquiries regarding whether ACO particip ant TINs need to self-nominate or register to participate in PQRS GPRO under the Shared Savi ngs Program, since there are such registration and self-nomination requirements under the traditiona l PQRS GPRO. We wish to clarify that no registration or self-nomination is required for ACO providers/suppliers that are eligible professionals to earn a PQRS incentive or a void the payment adjustment under the Shared Savings Program. Finally, just as ACO providers /suppliers that are eligible professionals in an ACO may1126 only participate under th eir ACO participant TIN as a gr oup practice under the PQRS GPRO under the Shared Savings Program for purposes of receiving an incentive under that TIN (76 FR 67903), we proposed that ACO providers/suppliers that are eligible professi onals within an ACO must participate under the ACO participant TIN as a group practice under the PQRS GPRO under the Shared Savings Program for purposes of the PQRS payment adjustment (77 FR 44990). Thus, ACO providers/suppliers who are elig ible professionals may not seek to avoid the payment adjustment by reporting either as an i ndividual under the traditional PQRS or under the traditional PQRS GPRO. We recognize that some eligible professi onals may move across programs and reporting options from year to year. For instance, an elig ible professional that is an ACO provider/supplier and participates in the PQRS under the Shar ed Savings Program in 2013 may later exit the Shared Savings Program and participate in PQRS individual reporting in 2014. Alternatively, a group practice participating in the traditional PQRS GPRO in 2013 may be an ACO participant in 2014. In instances in which eligible professionals change their PQRS reporting option from year to year, we believe that as long as the eligible profe ssional satisfactorily reported for purposes of the payment adjustment during the applicable reporting peri od, then the eligible professional should not be subject to the payment adjustment even if th e eligible professional was reporting under a different reporting method th an at the time the payment adjustment would be assessed.
Comment: We received one comment applauding our recognition that providers may shift across programs and reporti ng options from year to year . Several commenters supported our proposal that as long as an eligible profe ssional satisfactorily repor ted for purposes of the payment adjustment during the applicable reporti ng period, then the eligib le professional would not be subject to the payment adjustment even if the eligible professional was reporting under a1127 different reporting method than at the time the pa yment adjustment would be assessed. We did not receive any comments against our proposal or suggesting alternatives. Response : We appreciate commenters’ support a nd are finalizing our proposal that ACO providers/suppliers that are elig ible professionals must partic ipate under the ACO participant TIN as a group practice under the PQRS GPRO under the Shared Savings Program for purposes of the PQRS payment adjustment and that su ch ACO providers/suppliers who are eligible professionals may not seek to avoid the payment ad justment by reporting eith er as an individual under the traditional PQRS or under the traditiona l PQRS GPRO. For group practices and ACOs that may reorganize and individu al providers and groups of provide rs that may move in and out of ACOs from year to year, as long as the eligible professional sa tisfactorily reported for purposes of the payment adjustment during the applicable reporting peri od, then the eligible professional will not be subject to the payment adjustment even if the eligible professional was reporting under a different reporting method than at the time the payment adjustment is assessed, as long as that eligible professional is still bi lling under the same TIN at the time the payment adjustment is assessed as they were during the applicable reporting peri od. We believe this approach offers maximum flexibility for eligible professionals and groups of providers to make appropriate decisions regarding th eir participation in an ACO and allows ACOs to recruit new participants, by eliminating any risk that eligible professionals will be assessed with the payment adjustment as a result of such ch anges. We also believe it woul d be unfair to assess the payment adjustment on an eligible professional on the basis of the decision to either join or leave an ACO, if the eligible professional ha d satisfactorily reported during the applicable reporting period. Accordingly, we are finalizing the proposed amendment to the regulations at §425.504(b) with two modifications. We have revised §425.504(b)(2)(ii) to provide that an ACO, on behalf of its ACO providers/suppliers w ho are eligible professionals, must satisfactorily report one of1128 the GPRO measures during the reporting period according to the method of submission established by CMS under the Shared Savings Program for purposes of the 2015 Physician Quality Reporting System payment adjustment. Satisfactory reporting criteria for the PQRS payment adjustment under the Shared Savings Program for 2016 and beyond will be discussed in future rulemaking. Please note that, in this fina l rule with comment period, we also address final policies for ACO data to be publicly reported on Physician Comp are in section III.G. of this final rule with comment period and under Medicare Shared Sa vings Program regulati ons at §425.308. ACOs and the Value-Based Modifier are discussed in section III.I of this final rule with comment period. J. Discussion of Budget Neutrality for the Chiropractic Services Demonstration Section 651 of MMA requires the Secretary to conduct a demonstration for up to 2 years to evaluate the feasibility and advisability of expanding coverage for chiropractic services under Medicare. Current Medicare coverage for chiropr actic services is limited to treatment by means of manual manipulation of the sp ine to correct a subluxation desc ribed in section 1861(r)(5) of the Act provided such treatment is legal in the state or jurisdiction where performed. The demonstration expanded Medicare coverage to include: “(A) care for neuromusculoskeletal conditions typical among eligible beneficiaries; and (B) diagnos tic and other services that a chiropractor is legally authorized to perform by the State or juri sdiction in which such treatment is provided.” The demonstration was conducted in four geographically diverse sites, two rural and two urban regions, with each type including a Health Professional Shortage Area (HPSA). The two urban sites were 26 counties in Illin ois and Scott County, Iowa, and 17 counties in Virginia. The two rural sites were the States of Maine and New Mexico. The demonstration, which ended on March 31, 2007, was required to be budget neutral as sect ion 651(f)(1)(B) of1129 MMA mandates the Secretary to ensure that “t he aggregate payments made by the Secretary under the medicare program do not exceed the am ount which the Secretary would have paid under the medicare program if the demonstrat ion projects under th is section were not implemented.” In the CY 2006, 2007, and 2008 PFS final rules with comment period (70 FR 70266, 71 FR 69707, 72 FR 66325, respectively), we include d a discussion of the st rategy that would be used to assess budget neutrality (BN) and the method for adjusting chiropractor fees in the event the demonstration resulted in costs higher than those that would occur in the absence of the demonstration
. We stated that BN would be assessed by determining the change in costs based on a pre-post comparison of total Medicare costs fo r beneficiaries in the demonstration and their counterparts in the control groups and the rate of change for specific diagnoses that are treated by chiropractors and physicians in the de monstration sites and control site s. We also stated that our analysis would not be limited to only review of chiropractor claims because the costs of the expanded chiropractor services may have an imp act on other Medicare co sts for other services. In the CY 2010 PFS final rule with comment period (74 FR 61926), we discussed the evaluation of this demonstration conducted by Bra ndeis University and the two sets of analyses used to evaluate BN. In the “All Neuromusculo skeletal Analysis,” which compared the total Medicare costs of all beneficiaries who received services for a neuromuscu loskeletal condition in the demonstration areas with those of benefici aries with similar characteristics from similar geographic areas that did not participate in the demonstration, the total effect of the demonstration on Medicare spending was $114 milli on higher costs for benefi ciaries in areas that participated in the demonstrati on. In the “Chiropractic User Analysis,” which compared the Medicare costs of beneficiar ies who used expanded chirop ractic services to treat a neuromusculoskeletal condition in the demonstration areas, with those of beneficiaries with1130 similar characteristics who used chiropractic serv ices as was currently covered by Medicare to treat a neuromusculoskeletal condition from sim ilar geographic areas that did not participate in the demonstration, the total effect of the dem onstration on Medicare spending was a $50 million increase in costs. As explained in the CY 2010 PFS final rule, we based the BN estimate on the “Chiropractic User Analysis” because of its focus on users of chiropractic se rvices rather than all Medicare beneficiaries with neuromusculoskelet al conditions, as the latter included those who did not use chiropractic services and who may not have become users of chiropractic services even with expanded coverage for them (74 FR 61926 through 61927). Users of chiropractic services are most likely to have been aff ected by the expanded coverage provided by this demonstration. Cost increases and offsets, such as reductions in hospitalizations or other types of ambulatory care, are more likely to be observed in this group. As explained in the CY 2010 PFS final rule (74 FR 61927), because the costs of this demonstration were higher than expected and we did not anticipate a reduction to the PFS of greater than 2 percent per year, we finalized a policy to recoup $50 million in expenditures from this demonstration over a 5-year period, from CYs 2010 through 2014 (74 FR 61927). Specifically, we are recouping $10 million for each such year through adjustments to the chiropractic CPT codes. Payment under th e PFS for these codes will be reduced by approximately 2 percent. We be lieve that spreading th is adjustment over a longer period of time will minimize its potential negative impact on chiropractic practices. For the CY 2012 PFS, our Office of the Ac tuary (OACT) estimated chiropractic expenditures to be approximately $470 million, which reflected the statutory 29.4 percent reduction to physician payments scheduled to take effect that year. As noted above, the statute was subsequently amended to impose a zero percent update for CY 2012 instead of the 29.41131 percent reduction. OACT now estimates CY 2012 ch iropractic expenditures to be approximately $630 million. We are currently recouping $10 milli on through adjustments to the chiropractic CPT codes in CY 2012, and the percent of this reduction is approxima tely 1.5 percent. We are continuing the implem entation of the required BN adjustment by recouping $10 million in CY 2013. Our Office of the Actuary estimates chiropractic expenditures in CY 2013 will be approximately $470 million based on Medicare spending for chiropractic services for the most recent available year and reflecting an approximate 30.9 percent reduction to physician payments scheduled to take effect under curr ent law. To recoup $10 million in CY 2013, the payment amount under the PFS for the chiropractic CPT codes (CPT codes 98940, 98941, and 98942) will be reduced by approximately 2 percent. We are reflecting this reduction only in the payment files used by the Medicare contractors to process Medica re claims rather than through adjusting the relative value units (RVUs). Avoiding an adjustment to the RVUs would preserve the integrity of the PFS, particul arly since many private payers al so base payment on the RVUs. Therefore, as finalized in the CY 2010 PFS regulation and reite rated in the CYs 2011- 2012 PFS regulations, we are implementing th is methodology and recouping from the chiropractor fee schedule codes set forth above. Our methodology meets the statutory requirement for BN and appropriately impacts the ch iropractic profession that is directly affected by the demonstration. The following is a summary of the comments we received and our responses.
Comment : One commenter, representing chiropractor s, indicated that they continue to oppose our methodology for assuring budget neutrality under the demonstration. Instead of the application of an adjustment to the national chiropractor fee sc hedule, the commenter believes the Congressional intent was for CMS to make an adjustment to the totality of services payable under the Part B Trust Fund because of the langu age in Section 651(f)(A) of the MMA, which1132 directs the Secretary to "provide for the transfer from the Federal Supplementary Insurance Trust Fund...of such funds as are necessary for the cost s of carrying out the de monstration projects under this section." Response : Section 651(f)(1)(B) of the MMA requires that the Secretary "shall ensure that the aggregate payments made by the Secr etary under the medicare program do not exceed the amount which the Secretary would have paid under the medicare program if the demonstration projects under this section were not implemented." The statute does not specify a particular methodology for ensuring budget neutrality, but leaves that decision to the Secretary. In the CY 2010 Payment Policies un der the Physician Fee Schedule and other Revisions to Part B for CY 2010 final rule with comment pe riod (74 FR 61738, 61926-61928), we discussed our strategy for assessing budget ne utrality and finalized the met hodology for reducing the payment amount of the chiropractic CPT codes under the P hysician Fee Schedule in order to ensure the demonstration is budget neutral. See also the CY 2006, 2007, and 2008 Physician Fee Schedule final rules with comment period (70 FR 70266-70267, 71 FR 69707-69708, 72 FR 66325- 66326, respectively). Our methodology for reducing the payment of the chiropractic CPT codes (98940, 98941, and 98942) ensures budget neutrality, meets the statutory requirements in §651(f)(1) of the MMA, and appropriately impacts the chiropractic profession that is directly affected by the demonstration. The final evalua tion report, which describes, among other things, our methodology for calculating budget neutrality for this demonstration, is located on our website at http://www.cms.gov/reports/downloads /Stason_ChiroDemoEvalFinalRpt_2010.pdf

. Comment : The commenter referenced in the previous comment also noted that the increase in costs from the demons tration was completely due to the Illinois site, and not the other four sites. The commenter "has concerns that th e Chicago area did not m eet the criteria for an appropriate demonstration site fo r this project." The commenter believes it is "premature to use1133 demonstration findings to estimate the cost of a national roll out of the expansion of chiropractic services without further analysis of the demonstration project data." Response : Section 651(c)(1) of th e Act required the demonstration be conducted in 4 geographically diverse sites, sp ecifically two rura l and two urban regions, with each type including a Health Professiona l Shortage Area (HPSA). We discussed the design of this demonstration with the chiropractic industry and others prior to implementation. Based on these discussions, we included additional criteria for site selec tion in the design of this demonstration. The Chicago area met the site sel ection criteria for this demonstra tion. We refer readers to the January 28, 2005 Notice (70 FR 4130) for a discussion of our site selection criteria and the sites selected for participation based on these criteria. Regardless of the differences in the costs as sociated with the demonstration areas, the evaluation conducted by Brandeis University fo und that expanding coverage for chiropractic services under the demonstration resulted in incr eased Medicare expenditures, and the Secretary must recoup these costs in order to meet the budget neutrality requirement of the law. In response to the comment suggesting that th e data from this demonstration should not be used to estimate the cost of a national rollout of the expansion of chiropractic services, we note the following. At the time of the final Repo rt to Congress on the Chiropractic Services Demonstration, we estimated the costs of a natio nal rollout of the expa nsion of chiropractic services. We based our estimate on the best avai lable data at the time which was data from the demonstration. Further, data from the demons tration was the only information CMS had at the time of the Report to Congress for estima ting the costs of a national rollout. After consideration of th e public comments received, we are continuing the implementation of the required budget neutra lity adjustment by recouping $10 million in CY 2013 by reducing the payment amount under th e PFS for chiropractic codes (that is, CPT1134 codes 98940, 98941, and 98942) by approximately 2 percent. K. Physician Value-Based Payment Modifier and the Physician Feedback Reporting Program 1. Overview Section 1848(p) of the Act requires that we establish a value-based payment modifier and apply it to specific physicians and groups of phys icians the Secretary determines appropriate starting January 1, 2015 and to all physicians and groups of physicians by January 1, 2017. On or after January 1, 2017, the secti on 1848(p)(7) of the Act provides the Secretary discretion to apply the value-based payment modifier to e ligible professionals as defined in section 1848(k)(3)(B) of the Act. Base d on our initial experience with the program, we will consider whether to expand the application of the value- based payment modifier to additional eligible professionals as permitted by the Act. We proposed to apply the value-based payment modifier (a) to groups of physicians of 25 or more eligible professionals, (b) to align quality measurement for purposes of the value-based payment modifier with the reporting requireme nts for data on quality measures under the Physician Quality Reporting System (PQRS), a nd (c) to implement the value-based payment modifier so that it does not affect payment for those groups that satisfact orily report information on quality measures under the PQRS unless th e group of physicians expressly elect further assessment using a quality-tiering option. The stat ute requires the value-based payment modifier to be budget neutral. We are finalizing our overall approach to th e value-based payment modifier in which the value-based payment modifier adjustment is ba sed on participation in the PQRS. Although we are refining many of the proposed value-based payment modifier policies in response to comments received, the major change from our pr oposals is that we will apply the value-based payment modifier to groups of physicians of 100 or more eligible professionals rather than to1135 groups of physicians of 25 or more eligible profes sionals. We believe this change in policy is necessary in order for us to ga in additional experience with, and to be able to produce data to enhance physician acceptance of, our methodologies and approach. We emphasize that even with this change we are committed to applyi ng the value-based payment modifier to all physicians and groups of physicians by 2017 as requi red by Section 1848(p) of the Act. We urge solo practitioners and physicians in smaller gr oups to participate in the PQRS now, because when we propose in future rulemaking to apply the value-based payment modifier to smaller groups and solo practitioners, we anticipate basi ng the quality composite on PQRS quality data reported by such physicians. We al so anticipate that we would pr opose to increase the amount of payment at risk under the value-based payment m odifier as we gain additional experience with the methodologies used to assess th e quality of care furnished, and the cost of care, by physicians and groups of physicians. 2. Value-Based Payment Modifier Overview In the CY 2013 PFS proposed rule, we stated th at the value-based payment modifier has the potential to help transform Medicare from a passive payer to an active purchaser of higher quality, more efficient and e ffective healthcare by providing upward payment adjustments under the PFS to high performing physicians (and groups of physicians) and downward adjustments for low performing physicians (and groups of physic ians) (77 FR 44993). We recognize, however, that physicians are at the forefront of care de livery and that changes in payment policy can directly affect the medical care that physicians furnish to Medicare beneficiaries. Consistent with the National Quality Strategy, our aim is to promote preventive care and improve, rather than impede, the care that beneficiaries currentl y receive, especially for the chronically ill and those with the most complicated cases. We explained in the CY 2013 PFS proposed rule (77 FR 42908) that Medicare is1136 beginning to implement value-based payment adju stments for other types of services, including inpatient hospital services. We ha ve also outlined in reports to Congress strategies to implement value-based purchasing for skilled nursing faci lities, home health services, and ambulatory surgical center services. In im plementing value-based purchasing initiatives generally, we would meet the following goals:

● Recognize and reward high quali ty care and quality improvements. ++ Value-based payment systems and public re porting should rely on a mix of standards, processes, outcomes, and patient experience measur es, including measures of care transitions and changes in patient functional status. Across all programs, we would move as quickly as possible to the use of outcome and patient experience measures. To the extent practicable and appropriate, we believe these out come and patient experience measures should be adjusted for risk or other appropriate patient population or prov ider characteristics. ++ To the extent possible, and recognizing differences in payment system readiness and statutory requirements and authorities, meas ures should be aligned across Medicare and Medicaid’s public reporting and payment systems. We would seek to evolve a focused core set of measures appropriate to each sp ecific provider category that refl ects the level of care and the most important areas of service a nd measures for that provider. ++ The collection of information should mini mize the burden on providers to the extent possible. As part of that effort, we will c ontinuously seek to align our measures with the adoption of meaningful use sta ndards for health information t echnology (HIT), so the collection of performance information is part of care delivery. ++ To the extent practicable, the measur es we use should be nationally endorsed by a multi-stakeholder organization. Measures should be aligned with best practices among other payers and the needs of the end users of the measures.1137

● Promote more efficient and effective care through the use of ev idence based measures, less rework and duplication, a nd less fragmented care. ++ Providers should be accountable for th e costs of care, being both rewarded for reducing unnecessary expe nditures and responsible for excess expenditures. ++ In reducing excess expend itures, providers should contin ually improve and maintain the quality of care they deliver. ++ To the extent possible, and recognizing differences in payers’ value-based purchasing initiatives, providers should redesign care proces ses to deliver higher quality and more efficient care to their entire patient population. Because of the centrality of physicians to high-quality, efficient, patient-centered care furnished in multiple settings, we believe that in the long run the value-based payment modifier should rely on measuring physician performance (both quality of care and cost) at four levels (to the extent practicable) – the indi vidual physician level, the group pr actice level, the facility level (for example, hospital), and the community leve l. Physicians make decisions on a patient-bypatient basis as to what services are indicat ed and furnished. These decisions are made independently by physicians within multiple setti ngs (that is, individual office practice, group practice, and hospital) and are dependent, in part, on how care is organized in a community. Consequently, physicians have the potential to driv e both quality of care and costs at all levels of the health system and these decisions have an impact on patient outcomes and costs for populations of patients. We envi sion a physician value-based paymen t modifier in the future that blends performance at each of these levels (a s applicable) and reinfo rces our objectives to encourage and reward physicians for furnishing high-quality, efficient, patient-centered clinical

care. Given this long range objective, we proposed that the following spec ific principles should1138 govern the implementation of the value-based payment modifier.

● A focus on measurement and alignment. It is difficult to maintain high quality care and improve quality and performance without measurement. Therefore, the value-based payment modifier should incorpor ate performance on more quality measures than those that we finalized in the CY 2012 PFS final rule (76 FR 73429 through 73432). These additional measures for the value-based payment modifier should consistently reflect differences in performance among physicians and physician gro ups and reflect the di versity of services furnished. These measures should be consistent with the National Qual ity Strategy and other CMS quality initiatives, including the PQRS, th e Medicare Shared Savings Program, and the Medicare EHR Incentive Program.

● A focus on physician choice . Physicians should be able to choose the level at which their performance will be assessed reflecting physicians’ choice over their practice configurations. The choice of level should align with the requirements of other physician quality reporting programs, such as the PQRS and th e Medicare EHR Incentive program to reduce administrative burden and encourage greater program participation.

● A focus on shared accountability . CMS has a role in fostering high value care for individual beneficiaries, but also focusing on how that benefi ciary interacts with the healthcare system generally. We believe that the value- based payment modifier can facilitate shared accountability by assessing performance at the gr oup practice level and by focusing on the total costs of care, not just the costs of car e furnished by an individual physician.

● A focus on actionable information . In conjunction with adjusting payment based on performance, CMS should provide meaningful an d actionable information to help physicians identify clinical areas where they are doing well as well as areas in which performance could be improved. The Physician Feedback reports can serv e this purpose and we plan to continue to1139 provide groups of physicians with feedback reports on the quality a nd cost of care they furnish to their patients.

● A focus on a gradual implementation . We believe that the value-based payment modifier should focus initially on outliers (t hat is, those groups of physicians that are demonstrably high or low performers as compared to their peers that treat like beneficiaries). We also believe that groups of physicians should be able to elect how the value-based payment modifier would apply to their payment under th e PFS starting in 2015 as we phase-in the valuebased payment modifier. As we gain more e xperience with physician measurement tools and methodologies, we can broaden the scope of meas ures assessed to orga nize them around medical condition, refine physician peer groups to focus on how like beneficiaries ar e treated, create finer payment distinctions that focus on increasing va lue, and provide greater payment incentives for high performance. We solicited comments on these principles as guides to our implem entation of the valuebased payment modifier. The following is a su mmary of the comments we received and our
response. Comment : Commenters generally supported the fi ve principles that we proposed would govern the implementation of the value-based pa yment modifier. However, some commenters expressed concerns that the proposed implementa tion of the value-based payment modifier did not support all of the principles. One commenter stated that the proposed va lue-based modifier program was designed for large multispecialty group practices, not sma ll single specialty groups. Another commenter indicated that long term care physicia ns currently lack the infrastructu re to be able to achieve the proposed principles within the timeline proposed. Other commenters were concerned about the lag between the performance year (2013) and the application of the paym ent adjustment (2015)1140 and urged CMS to further explore ways to real istically achieve the goal cited under “Focus on actionable information.” One of the commenters also raised several co ncerns related to group reporting of the quality data. Some of the commenters’ r ecommendations included providi ng the Physician Feedback reports to all physicians sooner so they have information before impl ementation of the valuebased payment modifier; making group reporting optional; expanding the reporting options for large groups; and evaluating the implementati on proposals on small single specialty group practices and settings such as long term care settings. Response : We appreciate the commenters’ support of the five principles that we believe should govern the implementation of the value-based payment modifier. We address the narrower concerns raised by commenters later in this final rule with comment period, but continue to believe that the five principles we have iden tified here should guide the implementation of the value-based payment modifier. 3. Proposals for the Value-Based Payment Modifier In the proposed rule, we described our proposals for each component of the value-based payment modifier (77 FR 44995). In this fina l rule with comment period, we discuss our proposed policies for each component of the va lue-based payment modifier, the comments received, our responses to the comments, and a brief statement of our final policy. a. Application of the Value-Based Payment Modifier Section 1848(p)(4)(B)( iii) of the Act requires the Secr etary to apply the value-based payment modifier to items and services furn ished under the Medicare Physician Fee Schedule beginning on January 1, 2015, for specific physicians and groups of physicians the Secretary determines appropriate, and beginning not late r than January 1, 2017 for all physicians and groups of physicians. For purposes of the value- based payment modifier we are finalizing in1141 this final rule with comment period, physicians are defined in section 1861(r) of the Act to include doctors of medicine or osteopathy, doctors of dental surg ery or dental medicine, doctors of podiatric medicine, doctors of optometry, and chiropractors. (1) Definition of a Group, Group Size, and Appli cation of the Value-Based Payment Modifier to the Paid Amount We proposed to apply the value-based paym ent modifier beginning in calendar year 2015 to all groups of physicians with 25 or more e ligible professionals (77 FR 44995). For purposes of establishing group size, we proposed to use th e definition of an eligible professional as specified in section 1848(k )(3)(B) of the Act. This section defi nes an eligible professional as any of the following: (1) a physician; (2) a practi tioner described in sec tion 1842(b)(18)(C) of the Act; (3) a physical or occupational therapist or a qualified speech-language pathologist; or (4) a qualified audiologist. We pr oposed to define a group of physicians as “a single Tax Identification Number (TIN).” We chose this definition in order to align with the reporting requirements for group practices and the definitions used in the PQRS. We also proposed to assess whether a group of physicians has 25 or more eligible professional s at the time the group of physicians is selected to par ticipate under the PQ RS GPRO. In addition, we proposed to apply the valu e-based payment modifi er to the Medicare paid amounts for the items and services billed unde r the PFS at the TIN level so that beneficiary cost-sharing would not be affecte d. We also proposed to apply it to the items and services billed by physicians under the TIN, not to other eligible professionals that also may bill under the TIN. Application of the value-based payment modifier at the TIN level means that we would not “track” or “carry” an individual phys ician’s performance from one TI N to another TIN. In other words, if a physician changes groups from TIN A in the performance peri od (calendar year 2013) to TIN B in the payment adjustment period (cal endar year 2015), we would apply TIN B’s value-1142 based payment modifier to the physician’s paymen ts for items and services billed under TIN B during 2015. We made this proposal for two reas ons (77 FR 44995). First, payment at the group practice (TIN level) promotes shared accountability for the quality of care furnished at the group practice level. Second, we believe d it will be more straightforward for groups of physicians to understand how the value-based payment modifier affects their TIN’s payment in the payment adjustment period if all physicia ns billing under the TIN received the same value-based payment modifier.
Comment : Some commenters supported CMS’ proposal to apply the value-based payment modifier to only groups of 25 or more eligible professionals. They typically based their support on their agreement with the points CM S made in the proposed rule, stating that it would be premature to extend the value modifier to groups smaller than 25. However, many other commenters recommended that CMS apply the value-based payment modifier only to larger, multi-specialty groups, such as those with 100 or more physicians (MDs/DOs). Some of these commenters suggested that if single specialty or smaller groups were to be included, they should be limited to those groups that specifically request to be included. They reasoned that it would be important for CMS to devote resources to ensuring the program is successful with large groups before including smaller grou ps and solo practitioners. They stated that several issues are still untested and thus in need of further develo pment (for example, attribution for cost purposes, new quality reporting methods, cost measure co mparisons, and physician awareness). These commenters expressed concern, ba sed on prior experience with CMS’ confidential feedback reports, about the ability of CM S to notify and sign up a large number of groups by the proposed deadline. They stated that applying the value- based payment modifier initially only to larger groups would reduce the number of physicians a nd groups that would need to be notified and would focus on practices that ar e most likely to follow the fede ral regulatory process and have1143 staff devoted to value-based performance initiatives. Further, those commenters opined that tying the group size determination to the numbe r of MDs and DOs rather than to all PQRSeligible professionals would also eliminate potential misunderstand ing about the groups that are subject to the value-based paym ent modifier. Commenters also suggested that removing single specialty groups could mitigate a number of problem s such as a lack of relevant quality measures available for many specialties unde r the group reporting options. On the other hand, a few commenters suggest ed we apply the value-based payment modifier to additional physicians , such as those in groups of 10 or more. This suggestion was based on a view that increasing pa rticipation in the value-based pa yment modifier for the first 2 years of the program could faci litate a smoother transition to all physicians in 2017 (as required by law) and gain physician participation in the first few years. Another commenter recommended that CMS allow smaller practices to participate in the modifier in 2015 if they meet certain criteria, such as being Meaningf ul Users (MU) of certified Electronic Health Records (EHRs), or practicing in a rural state or other area where there are relatively few groups with 25 or more eligible professi onals (for example, Health Profe ssional Shortage Areas). These commenters reasoned that incorpor ating smaller practices into th e value-based payment modifier would encourage all physicians, not only larger groups, to focus on high-quality, affordable care, reinforcing current private and other payers’ payment incentives. Commenters stated a belief that a broader definition of physician group is imper ative if the value-base d payment modifier is to promote value on a wide scale, given that mo st physicians practice in groups of less than 10 physicians. Further, they argued that it would be feasible to in clude smaller practices in the value-based payment modifier because many of th ese smaller practices are participating in the EHR Incentive Program and they are currently reporting many of the same measures that are available to eligible professiona ls under the PQRS. In additi on, it was also noted that some1144 states with a high proportion of rural and other under-served areas may have comparatively few groups of 25 or more eligible professionals a nd thus be under-represented in the value-based payment modifier unless smaller groups are included. Response : We are persuaded by the commenters that recommended we apply the valuebased payment modifier only to larger groups. We agree with commenters that suggested the minimum group size be defined as groups of physicians with 100 or more eligible professionals as a first step. We believe it would be reasonable to focus on groups with 100 or more eligible professionals before expanding the application of the value-based payment modifier to more groups. We believe that increa sing the group size from 25 to 100, we would be addressing the concerns raised by commenters regarding attr ibution, new group reporting mechanisms, and cost comparisons. We also agree with commenters th at we will be more successful in notifying and informing these large groups about the requirement s of the value-based paym ent modifier than if we were to include groups of less than 100 elig ible professionals. We do not agree, however, that the group size should be determined only by the number of physicians (MDs, DOs), because we still seek to align with the quality measure reporting criteria in the PQRS; that is, under the PQRS, group practices ar e defined by the number of eligib le professionals as defined under section 1848(k)(3)(B), not ju st physicians. We believe it woul d be confusing to have the same group size (for example, 100) be calculated different ways (one way for the PQRS and another way for the value-based payment modifier), b ecause the group’s partic ipation in the PQRS informs how they are treated for th e value-based payment modifier.
Comment : Some commenters believed it was e ssential for CMS to provide additional flexibility to allow groups to define themselves rather than using our proposed definition of a group of physicians as “a single Tax Identifi cation Number (TIN).” For example, some commenters urged us to allow groups to aggregat e TINs for the value modifier, indicating that1145 due to a variety of business reasons unrelated to quality reporting, some practices have multiple TINs. In these practices, such as some facu lty practice plans, the departments share common services and are perceived by the public as being part of the same practice. Other commenters suggested that CMS allow certain practices, such as large prac tices that operate under a single TIN, an option to disaggregate the TIN into separate component sub-groups in a way that represents how the grou ps functionally operate. Response : We are finalizing our pr oposal to identify the gro up by its Medicare-enrolled TIN. Using TINs makes it possible for us to ta ke advantage of infrastructure and methodologies already developed for PQRS gr oup-level reporting and evaluation. We believe this approach affords us flexibility and statis tical stability for monitoring an d evaluating quality and outcomes for beneficiaries assigned to the group for quality reporting purposes. In contrast, adopting approaches suggested by some commenters to a llow the disaggregation of a TIN (or aggregation of a collection of TINs) would create much gr eater operational complexity by requiring us to establish and maintain additional organizati onal IDs under each TIN (for disaggregation purposes) or among TINs (for aggr egation purposes). It would be difficult operationally to maintain such an approach to accommodate future organizational changes among physicians and their practices. TINs are relatively stable ove r time, but still allow for some flexibility as individual physicians make choi ces about what TINs they establ ish. Despite these challenges and our decision to define a group of physicians as a “single TIN,” we intend to examine whether it is possible in future years to allow for the a ggregation or disaggregati on of TINs in order to better reflect physician group organizati on as suggested by the commenters.
Comment : Some commenters disagreed with th e proposal to apply the value-based payment modifier to the items and services bill ed by eligible professiona ls who are physicians under the TIN and not to other eligible professionals that also may bill under the TIN. They1146

reasoned it is inconsistent to apply the value-based payment modifier only to items or services billed by eligible professionals who are physic ians, given that under the proposal CMS would count all eligible professionals for purposes of determining group size. These commenters generally requested consistency between the as sessment of group size an d application of the value-based payment modifier. By contrast, we also received suggestions that we ought to exclude non-physicians in the gr oup size determination but apply th e modifier to all eligible professionals within a medical group practice. These commenters argued that this approach would be more consistent with the view that hi gh quality and coordinate d care is a team effort. Response : Section 1848(p)(7) of th e Act requires us to appl y the value-based payment modifier beginning in 2015 only to physicians as defined in section 1861(r) of the Act. On or after January 1, 2017, the Act provides the Secretar y discretion to apply th e value-based payment modifier to a broader set of e ligible professionals (as defined in section 1848( k)(3)(B) of the Act). Thus, we are unable at this time to appl y the value-based payment modifier to Medicare FFS payments paid to eligible professionals who are not physicians as suggested by the commenters. Based on our initial experience with the value-based payment modifier, we plan to consider whether to expand its application to additio nal eligible professionals in future years. As discussed previously, we believe it is important to use the same definition of group size (that is, eligible professionals) as the PQRS both to align the two programs (the PQRS and the valuebased payment modifier) and to help avoid physic ians’ confusion as they determine the method by which they will participate in the PQRS.
Comment : We received few comments on our proposals to apply the value-based payment modifier to the Medicare paid amounts for the items and services billed under the PFS so that beneficiary cost-shari ng or coinsurance would not be affected. These commenters generally agreed with th e proposal to apply the value-based payment modifier to the Medicare1147 paid amounts for the items and services billed unde r the PFS at the TIN level so that beneficiary cost-sharing would not be affected. Response : We agree with these comments. We c ontinue to believe it is important that beneficiary cost-sharing notbe affected by the value-based payment modifier.
Comment : Several commenters requested clar ification of when and how we would determine group size if the group of physicians did not participate in the PQRS. This determination is important, they reasoned, because these groups would be subject to the -1.0 percent value-based payment downward adjustment under the value-based payment modifier if they were a group of physicians meeting the va lue-based payment modifier size requirement and they had not participated in the PQRS. Response : We had proposed to assess the size of a group of physicians at the time the group of physicians is selected to participate under the PQRS GPRO. As discussed above with respect to the PQRS GPRO self-nomination pro cess (section III.G.1) and below with respect to the election of the quality-tie ring approach, we have extend ed to October 15, 2013, the time period for groups of physicians to submit their se lf-nomination statement to select their PQRS reporting method and to elect the quality-ti ering methodology. As such, we will query Medicare’s Provider Enrollment, Chain, and Own ership System (PECOS) as of October 15, 2013, to identify the groups of physicians with 100 or more eligible professionals. This query will produce a list of the groups of physicians that are subject to the value-based payment modifier. To ensure that the groups of physic ians on this list have 100 or more eligible professionals during the performance period, we will analyze the gr oup’s (TIN’s) claims submitted for services furnished during the performance year, including at least a 60-day claims runout (that is, we will analyze claims submitte d through at least February 28, 2014 for services furnished during the calendar year 2013 perfor mance year). We w ill remove a group of1148 physicians from this list if the group does not have at least 100 eligible pr ofessionals that billed under the group’s TIN during the performance period. We note that we will not add groups to the October 15 list based on this claims analysis, rather we will only remove groups that, based on claims, do not have 100 or more eligible prof essionals. We also will engage in education and outreach during the pe rformance year to encourage all gr oups of physicians, not just those to which the value-based payment modifier ap plies during 2015, to participate in the PQRS. In response to the comments, we are finaliz ing that beginning in calendar year 2015 we will apply the value-based payment modifier to groups of physicians of 100 or more eligible professionals. We also are finalizing the followi ng proposed policies relate d to the definition of a group and group size:

● For purposes of establishing group size on ly, we use the definition of an eligible professional as specified in se ction 1848(k)(3)(B ) of the Act;

● We apply the value-based payment modifier to the Medicare paid amounts for the items and services billed under the PFS at the TI N level so that benefici ary cost-sharing is not be affected; and

● We apply the value-based payment modifi er to the items and services billed by physicians under the TIN, not to other eligible professionals that also may bill under the TIN.

● We identify the groups of physicians s ubject to the value-based payment modifier (groups of 100 or more eligible professiona ls) based on a query of PECOS on October 15, 2013, and we remove any groups from this October 15 list if, based on a claims analysis, the group of physicians did not have 100 or more eligible professionals that submitted claims during the performance period. (2) Approach to Setting the Value-Based Pa yment Modifier Adjustment Based on PQRS Participation and the Quality-Tiering Option1149 We explained in the proposed rule that our proposals would allow groups of 25 or more eligible professionals to decide how the value-ba sed payment modifier would be applied to their PFS payments (77 FR 44995). We proposed that in light of our desire to align CMS quality improvement programs, the value-based paymen t modifier methodology relies, in part, on the data submitted on quality measures by groups of physicians through the PQRS. We explained that quality measurement is ne cessary, but not sufficient, for quality improvement and a focus on value. Thus, we proposed to categorize grou ps of physicians eligible for the value-based payment modifier into two categories depending upon whether they had met the criteria for satisfactory reporting of data on the PQRS GRPO quality measures for the 2013 and 2014 incentive payments under the PQRS or the cr iteria for satisfactory reporting using the administrative claims-based reporting mechan ism, which was proposed for the 2015 and 2016 PQRS payment adjustment. For those groups of physicians that met either of these PQRS satisfactory reporting criteria and requested that their valu e-based payment modifier be calculated using a quality-tieri ng approach, we proposed to us e the performance rates on the quality measures reported through any of these PQ RS reporting mechanisms available to them. We proposed that the second category incl ude those groups of physicians with 25 or more eligible professionals that have not met the PQRS satisfact ory reporting criteria identified above (77 FR 44996). Because we would not have quality measure performance rates on which to assess the quality of care furnished by th ese groups, we proposed to apply a value-based payment modifier of -1.0 percent, meaning th ey would receive 99.0 perc ent of the paid amounts for the items and services billed under the PFS in CY 2015. We explained that we were concerned, how ever, that some groups of physicians may attempt to submit data on PQRS quality measures and fail to meet the criteria for satisfactory reporting for the PQRS incentive and thus be pl aced into the second category of groups of1150 physicians and, therefore, be subject to th e -1.0 percent value-based payment modifier downward adjustment. To address this issu e, we solicited comment s on whether to assess performance on the measures included in the PQ RS administrative claims-based reporting option as a default if a group of physicians attemp ts to participate in one of the PQRS GPRO reporting mechanisms and does not meet the PQRS criteria for satisfactory reporting.
Comments : The majority of commenters supported CMS’ use of the PQRS system as the foundation for the measurement of performance rates for physician groups for the value-based payment modifier. Many commenters stated this approach was a way to better align reporting requirements across physician programs and d ecrease burden. They also believed it was reasonable to phase-in the value-based payment modi fier using this two-category structure. By contrast, some commenters sugges ted that applying the -1.0 per cent downward adjustment to groups of physicians in the second category wa s penalizing these groups twice (once by the PQRS payment adjustment and once by the value-based payment modifier) for the same action, namely failure to report satisfactorily under th e PQRS. Other commenters opposed allowing the use of performance rates on the quality measur es reported through PQRS reporting mechanisms. They expressed concern that PQRS reporting methods are “overwhelming given the multiple methods of reporting, varying reporting periods , differing reporting requirements for each reporting mechanism.” One commenter stated that while it supported streamlining CMS quality programs, it had longstanding concerns with th e PQRS program and as a result, opposed the concept of tying particip ation in the value-based payment modifi er to participation in the PQRS. One commenter requested a value-based modi fier of 0.0 percent be applied in 2015 for pathologists as there would be no applicable PQRS measures. Response : We continue to believe that the two- category approach is a reasonable way to phase-in the value-based payment modifier in 2015. It is difficult to maintain high-quality care1151 and improve quality and performance without m easurement. We agree with commenters who stated that we should seek to align quality reporting mechanisms across physician programs. CMS has one physician quality repo rting system and we intend to use it as the foundation for the value-based payment modifier. Although not satisfactorily reporting data under the PQRS will subject physicians and groups of physicians to a PQRS payment adjustment, the lack of quality data also prevents us from fully assessi ng the quality of care furnished compared to cost. At the same time, we also believe we shoul d not affect the payment of those groups of physicians that have taken steps to participate in the PQRS and have developed systems within their practices to report data fo r quality measurement. Thus, in response to comments, we have decided to modify the two categories that we pr oposed and instead, we ar e finalizing a policy to apply the -1.0 percent downward value-based pa yment modifier adjustment only to those groups of physicians that do not participate in the PQRS in CY 2013 as described below
Comment : Many commenters urged CMS to hold groups harmless from the -1.0 percent value-based payment modifier downward adjustment if the group of physicians attempts, but is not a satisfactory reporter for the PQRS incenti ve payment. Commenters felt this was a good way to transition physician groups with little experien ce with PQRS reporti ng to do so without the threat of being subject to the value-based payment modifier and PQRS payment adjustments. Also, commenters stated that given the comp lexity of the PQRS, medical groups would be deterred from reporting data if th ey did not have a safety net to avoid being subject to both the value-based payment modifier and PQRS payment adjustments. Response : We agree with commenters that we should encourage groups of physicians to participate in the PQRS GPRO. Accordingly, we are expanding the first category of groups of physicians to which we would apply a value-base d payment modifier adjustment of 0.0 percent to include those groups that self -nominate for the PQRS GPRO and report at least one measure.1152 Further, if such group of physicians had electe d the quality-tiering opti on and did not meet the satisfactory reporting crit eria for the PQRS payment incen tive using the reporting method they selected in their self-nomination statement under the PQRS GPRO (such that we would not have performance information to create a quality composite), we will develop and use the group’s performance on the administrative claims-based reporting option as the basis for determining the group’s quality composite for purposes of the valu e-based payment modifier. We believe this policy will encourage groups to put systems in pl ace in their practices to become satisfactory PQRS reporters. Based upon the comments received, we ar e adopting our proposed policy, with one modification, to categorize groups of physicians eligible for the value-based payment modifier into two categories. Specificall y, the first category of groups of physicians includes those that (a) have self-nominated for the PQRS as a group and reported at least one measure or (b) have elected the PQRS administrative claims option for CY 2013 We note that groups in category (a) also include those groups that have self- nominated and have met the satisfactory reporting criteria for the PQRS incentive payment. The value-based payment modifier for the groups of physicians in this first category (both (a) a nd (b)) will be 0.0 percent, meaning no payment adjustment will be applied to physicians in these groups for CY2015. For those groups of physicians within this first catego ry that have requested that th eir value-based payment modifier be based on quality-tiering and have either met the satisfactory reporting criteria for the PQRS incentive or have chosen the administrative cl aims-based option, we will use the performance rates on the quality measures reported through thes e reporting mechanis ms (that is, GPRO registries, web-interface, or administrative cl aims) to calculate their value-based payment modifier. Otherwise, we w ill use the group’s performance on the administrative claims measures for quality-tiering, b ecause although the group self-nomin ated and reported at least1153 one measure, we would not have sufficient quality information to construct a quality composite under the quality-tiering approach. The second category includes those groups of physicians with 100 or more eligible professionals that do not fall within either of the two subcategories of category 1 described above. The value-based payment modifier for th ese groups of physicians will be -1.0 percent in
CY 2015.
Comment : Commenters requested that we clarif y whether physicians that are reporting PQRS measures at the individua l level and are members of groups subject to the value-based payment modifier would be able to continue to report as i ndividuals using their currently preferred PQRS option at the indivi dual level. They explained that they already have systems in place and staff that understands how to report under the PQRS at the individual level. They also opined that such flexibility allowed physicians in the group to choose PQRS measures that were most applicable to their practice and patients. Response : We appreciate commenters’ support for the use of the PQRS as the foundation for quality reporting for the value-ba sed payment modifier. We agree with the commenters that we should continue to encour age physicians in groups subject to the valuebased modifier and who are alr eady satisfactorily reporting PQRS measures as individuals to have the option to remain indivi dual PQRS reporters. We wish to clarify that in our proposals we did not intend to preclude individual partic ipation in the PQRS. We specifically proposed that groups of physicians subjec t to the value-based payment m odifier could elect the PQRS administrative-claims based option. Therefore, we are adopting a polic y that physicians in groups of 100 or more eligible prof essionals that wish to report da ta for quality measures in the PQRS as individuals rather th an as a group for the PQRS paym ent incentive must, as a group, elect the administrativ e claims-based reporting method und er the PQRS by October 15, 2013.1154 By doing so, the group of physicians would fall w ith category 1(b) and avoid the -1.0 percent downward value-based payment modifier. In future rulemaking, we anticipate proposing whether and how to combine quality measures reported at the individual level into a group quality score for the value-based payment modifier.
Comment : We received a substantial number of comments in support of the optional nature of having us evaluate performance based on the quality of care performance. One commenter recommended that quality-tiering re main voluntary until CMS has more confidence in its measures and composites. But we also received several comme nts that quality-tiering should not be optional. Response : We agree with commenters that application of the quality-tiering methodology for calculating the value-based payment modifier should be optional. There will be many groups of physicians participating in the PQRS for the first time in 2013, many of them using the new group reporting mechanisms under the PQRS that are described in Table 92 above. We believe it is reasonable for them to gain experience in reporting data for quality measurement under the PQRS. In addition, we will be establishing national benchmarks for the first time for the quality measures in the PQRS and we will be using these benchmarks in the quality-tiering calculation. We believe groups of physicians should have time to understand how their performance compares to these benchmarks, and to have time to adjust their performance based on these comparisons, before their payment is ad justed. Although we recognize the need to improve the quality of care furnished compar ed to cost, we believe it is unreasonable to make quality-tiering mandatory in the first year of the phase-in for the valuebased payment modifier. We anticipate for futu re years, as we collectively learn from our experiences with quality measur ement and the value-based payment modifier, we will consider making quality-tiering mandatory.1155 (3) Individual Physicians We proposed that, starting in 2017, we woul d apply the value-based payment modifier to all physicians and groups of physicians as required by the statute (77 FR 44996). We also solicited comments on whether we should offer individual physic ians and groups of physicians with fewer than 25 eligible professionals an op tion that their value-based payment modifier be calculated using a quality-tiering approach starting in 2015 (77 FR 44996). If we did so, we indicated that we could calculate a value-based payment modifier for groups of physicians with as few as two eligible professionals and appl y the value-based payment modifier at the TIN level in the manner described in these proposals for groups of 25 or more eligible professionals. Likewise, we solicited comments on how to ad apt our proposals to cal culate a value-based payment modifier at the TIN level for physicians in solo practices (TINs comprised of one NPI).
Comment : There were a few comme nters that supported applic ation of the value-based payment modifier to individual phys icians or EPs. For example, a commenter indicated that we should allow individuals that m eet PQRS reporting requirements th e option to participate in the quality-tiering option as early as possible as all physicians wi ll be subject to the payment adjustment in 2017. However, most commenters agreed with the proposal to only apply the value-based payment modifier to groups at this time for the reas ons outlined in the proposed rule (77 FR 44996). Response : We appreciate the comments that were provided on this issue and will consider them further as we de velop future plans to apply the value-based payment modifier to individual physicians. As discussed above, we are adopting a policy to apply the value-based payment modifier to groups of physicians of 100 or more eligible professionals. We will not offer smaller groups of physicians and individual physicians the abil ity to elect quality-tiering for the 2015 value-1156 based payment modifier as suggested by some commenters. Although we recognize that we must apply the value-based payment modifier to all physicians and groups of physicians starting January 1, 2017, we believe it is important to phase-in the value-based payment modifier to larger groups of physicians as we gain experi ence with the methodologi es used in the valuebased payment modifier. We want to emphasi ze, however, that in future rulemaking we anticipate proposing for smaller groups and fo r individual physicians a value-based payment modifier structure similar to th e policies we are adopting for groups of physicians of 100 or more eligible professionals. Importan tly, we expect the value-based payment modifier structure for smaller groups and individuals would also be aligned with the PQRS. Thus, we strongly encourage smaller groups of physicians and indivi dual physicians to partic ipate in the PQRS so that they can prepare themselves and their prac tices for the application of value-based payment modifier in later years. (4) Hospital-Based Physicians We also solicited comments on whether we should develop a value-based payment modifier option for hospital-based physicians to elect to be assessed base d on the performance of the hospital at which they are based (77 FR 44996) . In particular, hospital performance could be assessed using the measure rates for the quality measures in the Inpatient Quality Reporting (IQR) and the Outpatient Quality Reporting (OQR ) programs. We solicited comments on which IQR and OQR measures (and applic able reporting period) would be appropriate to include in such an option and a way to identify and veri fy whether physicians are hospital-based. The following is a summary of the comments we received regarding whether we should develop a value-based payment modifier option for hospital-based physicians.
Comment : A few commenters, including some that represent or employ physicians that practice in hospital settings, submitted comments on this issue. These commenters generally1157 agreed that CMS should devel op a value-based payment modifi er option for hospital-based physicians, some noting that this option should be voluntary and based on self-nomination. They believed this hospital-based option could crea te a shared incentive between hospital-based physician groups and their institutions to augmen t physician involvement in quality improvement initiatives relating to inpatient care. This alignm ent, particularly for hospitalists who are directly involved in the quality improvement efforts of th e hospital, could enhance and refine the safety and quality of hospital care. Some commenters urged CMS to be judicious when selecti ng measures from the IQR and OQR programs to ensure that hospitalist care is m easured in a valid way. Some potential areas for performance measures were identified, such as to include transitions of care/discharges and common diagnoses like congestive heart failure (CHF), acute m yocardial infarction (AMI), pneumonia and stroke. A number of these co mmenters requested that physicians and group practices should be able to identify themselves as “hospitalists” ensuring that they are compared to like-groups within the value- based payment modifier. Some co mmenters were concerned that our proposed beneficiary attributio n approach and our total per cap ita cost measures could result in hospitalists being inaccurately measured, as they could be at tributed the total cost of the patients’ stay at a hospital, when the hospitalist may have only been responsible for discharging the patient. Therefore, a commenter recommen ded that an attribution methodology be developed to accurately capture the role of hospitalists in patient care. Response : We appreciate the comments received and will consider them as we develop future proposals for the value-based payment modifier as they relate to hospital-based physicians. (5) Quality-Tiering Election Process We solicited comments on how best to ascer tain whether a group of physicians subject1158 to the value-based payment modifier request s the option that their value-based payment modifier be calculated using a quality-tiering approach (77 FR 44996). We are seeking to establish a system that is as simple as possi ble to reduce administrati ve burden on physicians and enable these groups of physicians to indi cate how they plan to submit data on quality measures through the PQRS for purposes of the value-based payment modifier. We described three possible approaches to accomplish these objec tives: (a) build off of the self-nomination process that we have proposed for groups of phys icians to participate in the PQRS GPRO and which requires groups to submit a self-nomina tion application by January 31, 2013 for the 2013 performance period, (b) create a separate web-based registration system that permits groups of physicians to, throughout calendar year 2013, reques t that their value-ba sed payment modifier be calculated using the quality-t iering approach, or (c) require that groups of physicians submit a letter (in a prescribed format) to CMS in a timely manner.
Comment : Commenters indicated that they appr eciated that CMS is seeking to reduce administrative burden when identifying the way groups of physicians would indicate that they request their value-based paymen t modifier to be calculated us ing a quality-tiering approach. These commenters generally support using a we b-based registration system or other simple online approach to opt into the quality-tieri ng that allows for ongoing registration by groups throughout the relevant calendar year. Response : We thank commenters for their comment s. To ease administrative burden and to align the quality-tiering election process with the self- nomination processes under the PQRS (as described in section III.G.1.b.(2) and III.G.1.c above), we are finalizing a web-based system for groups of physicians to request th e quality-tiering methodology. Under this policy, groups of physicians would access the same web- based system to request the quality-tiering approach that they use either to submit their PQ RS GPRO self-nomination statement or to elect1159 administrative claims option. We also are fina lizing a contingency plan to accept groups of physicians’ statements indicati ng their quality-tieri ng election via mail inthe event the webbased functionality is not available in time to accept these statements, or in the event we experience issues with accepting self-nomination statements via the web. For the same reasons we discussed above with regard to other de adlines we are adopting under the PQRS, such quality-tiering elections must be received by October 15, 2013. We believe utilizing the same processes and deadlines finalized by the PQRS will ease administrative burden and facilitate the election of the quality-tiering option. We want to emphasize that if a group of physicians with 100 or more eligible professionals does not self-nominate to par ticipate in the PQRS GPRO or elect the administrative claims option for groups for CY 2013, its value-based payment modifier in CY 2015 will be -1.0 percent. (6) Participants in the Medicare Shared Savings Program and Center for Medicare and Medicaid Innovation initiatives We proposed that groups of physicians that are participating in the Medicare Shared Savings Program or the testing of the Pioneer ACO model, assuming they meet the PQRS satisfactory reporting criteria, would not have the option that their value-based payment modifier be calculated using the quality-tiering a pproach (77 FR 44996-44997). We made this proposal because we were mindful that the physicians and groups of physicians that are, or will be, participating in the Shared Savings Program and the testing of the Pioneer ACO model have made sizable investments to redesign care proces ses based on the incentives created by these programs and did not wish to unintentionally distur b these investments. Therefore, we solicited comments on ways to structure th e value-based payment modifier starting in 2017 so it does not create incentives that conflict with the goals of the Shared Savings Program and the Pioneer1160

ACO model. We also solicited comments on whethe r groups of physicians th at are participating in these two initiatives should have the option that their valu e-based payment modifier be calculated using a quality-tiering approach and applied to their payments under the PFS starting in 2015.
Comment : Many commenters supported the propos al. A few commenters, especially those that supported broader opportu nities for participation in th e value-based payment modifier, likewise recommended that ACOs of both type s (Shared Savings Program and Pioneer ACO model) should be permitted, but not required, to participate in th e value-based payment modifier. Some recommended that ACOs be permitted to pa rticipate in the value-based payment modifier starting January 1, 2015. Such commenters believedthat to the extent these groups furnish highquality, low-cost care, they s hould have the opportunity to be rewarded for the value they furnish. They also believed that having a broader array of participants in the early years of the value-based payment modifier w ould facilitate the full-scale implementation in later years. Some commenters also noted that providing ACOs this option would also promote alignment with the Hospital Value-Based Purchasing Program in which hospitals participating in ACOs are permitted to participate. Another commenter enc ouraged CMS to further explore how to apply a value modifier to ACO-participating groups’ PFS payments prior to 2017; for example, perhaps CMS could apply a value modifier to PFS payments for all patients who are not attributed to the ACO. A commenter noted that they were awar e of several commercial plans with ACO-type contracts that simultaneously maintain ACO and pay-for-performance initiatives. In one case, the type of incentive follows the patient: provi ders receive the ACO program’s incentives for patients attributed to that a rrangement, and pay-for-performance incentives are based on care furnished to other patients the practice treats, bu t who do not meet the ACO’ s attribution criteria. The commenter believed this approach woul d avoid CMS’s concern about unintentionally1161 disturbing providers’ ACO invest ments while encouraging a singl e standard of high-quality, affordable care for all patients seen by the practi ce. Several commenters that are participating in the Innovation Center’s Comprehensive Primary Care Initiative also sugges ted that we not apply the value-based payment modifier to them and/or not offer the quality-tiering approach, because they are collecting quality information, are eligib le for shared savings, and are being held to a different programmatic struct ure with different incentives. Response : We are finalizing and clarifying our proposal not to apply the value-based payment modifier for 2015 and 2016 to groups of phys icians that are participating in the Shared Savings Program or the testing of the Pioneer AC O model. This policy means that such groups of physicians also will not have the option to elect quality-tiering because we will not apply the value-based payment modifier to them. At this early stage of the Medicare Shared Savings Program and the Innovation Center initiatives, we do not wish to unintentionally disturb their investments in implementing these programs. In addition, we also will no t apply the value-based payment modifier in 2015 and 2016 to groups of physicians that are participating in other Innovation Center initiativ es, such as the Comprehensive Prim ary Care initiative, or other CMS programs which also involve shared savings and participants making substantial investments to report quality measures and to fu rnish higher quality, more efficien t and effective healthcare. In sum, we will not apply the value-base d payment modifier for 2015 and 2016 to groups of physicians that are participating in the Medi care Shared Savings Program, the testing of the Pioneer ACO model, or other similar Innovation Center or CMS initiatives. b. Performance Period We previously finalized CY 2013 as the initi al performance period for the value-based payment modifier that will be applied in CY 2015 (76 FR 73436). This means that we will use performance on quality and cost measures during CY 2013 to calcula te the value-based1162 payment modifier that we would apply to item s and services for which payment is made under the PFS during CY 2015. Likewise, we proposed that performance on quality and cost measures in CY 2014 be used to calculate the va lue-based payment modifier that is applied to items and services for which payment is made under the PFS during CY 2016 (77 FR 44997). As we explained in the CY 2012 PFS final rule with comment period (76 FR 73435), we explored different options to close the gap be tween the performance period (that is, 2013) and the payment adjustment period (that is, 2015) , but found that none of them would have permitted sufficient time for physicians and groups of physicians to report measures or have their financial performance measured over a mean ingful period, or for us to calculate a valuebased payment modifier and notify physicians an d groups of physicians of their quality and cost performance and value-based payment modifier prior to the payment adjustment period. We also explained that a system that adjusted payments to take into account the value-based payment modifier after claims have been paid would be onerous on physicians and beneficiaries. We continued to explore ways to provide more timely feedback to physicians and to narrow the gap between the performance pe riod and the payment adjustment period and solicited comments on practical alternatives that we could implement to do so. We solicited comments on our proposal to use CY 2014 as th e performance period for the 2016 value-based payment modifier (77 FR 44997).
Comment : Although we did not seek comment on the use of 2013 as the performance period for the value-based payment modifier starting in 2015, a number of commenters expressed concern that it was premature to us e 2013 as the initial pe rformance period for the 2015 value-based modifier. These commenters s uggested that under the pr oposal, CMS in effect advanced the statutory implementa tion date by 2 years. They e xpressed concern that there will be insufficient time for CMS to communicate to a ll of the affected physic ians and groups that1163 they must sign-up to participate in the PQRS GP RO in the 3-month span between the publication of this final rule and the propos ed self-nomination dead line for participating in the PQRS GPRO. In addition, some commenters stat ed that additional testing and analysis is required to further refine the methodology and ensure that the modifier is fair and reliable. They suggested that CMS could and should use the time between now and 2015 to do further te sting and refinement of the modifier’s components rather than esta blish 2013 as the initial performance period. In addition, commenters objected to the lag between the performance period (2013 or 2014) and the payment adjustment period (2015 or 2016, respectively). Response : As previously noted, we already fi nalized our proposal to use 2013 as the performance period for the value-based payment modifier in 2015. For the reasons noted above and below, we are finalizing calendar year 2014 as the performance period for the value-based payment modifier in 2016. We have taken steps to phase-in the value-based payment modifier in a very gradual and cautious manner, as further ev idenced by the fact that we are adjusting our policy to apply the value-based payment modifier to groups of physicians of 100 or more eligible professionals (rather than to gr oups of physicians of 25 or more eligible professionals) and the policy to allow such groups to select whether the quality-tiering appro ach would apply to the calculation of the value-based pa yment modifier. As we discu ssed above, our first principle guiding implementation of the value-based payment modifier is a focus on measurement. Thus, we believe it is essential to en courage greater reporting and we be lieve this activity should not be delayed. Although we agree with commenters sugges tions to analyze differe nt ways to structure and implement the value-based payment modifier, we need data on quality to do so. Thus, we believe it is imperative to begin phasing in the value-based payment modifier with an emphasis on encouraging all physicians and groups of physicia ns to participate in the PQRS. Moreover, given that all physicians will have to report data on quality meas ures under the PQRS or else be1164 subject to the PQRS payment adjustment, we belie ve it is reasonable to align the programs to encourage greater reporting participation. Finall y as discussed above in section III.G.1.b above, we have extended to October 15, 2013 the time pe riod during which groups of physicians subject to the value-based payment modifier can indicat e their preferred PQRS reporting mechanism and whether they choose the quality-tiering approach. Therefore, we are finalizing our proposal to use CY 2014 as the performance period for the 2016 value-based payment modifier. c. PQRS Quality Reporting Methods and Quality MeasuresIn this section we discuss our policies to align quality measure reporting for the valuebased payment modifier with the PQRS reportin g methods, and to expand the range of quality measures that we will use for the value-based payment modifier. (1) Alignment of Quality Reporting Options with the PQRS In the proposed rule we proposed to categ orize groups of physicians eligible for the value-based payment modifier into two categor ies depending upon their participation in the PQRS (77 FR 44997). We further elaborated on these proposals and proposed that groups of physicians subject to the value-ba sed payment modifier would be able to submit data on quality measures using one of the following proposed PQ RS reporting mechanisms : PQRS GPRO using the web-interface, claims, registries, or EHRs; or PQRS administrative claims-based option. We also sought comment on which PQRS reporting mechanisms we should offer to individual physicians if we were to apply the value-base d payment modifier to their payments under the PFS starting in 2015 and 2016.
Comment : As discussed previously, the majority of commenters supported CMS’ use of the PQRS as the foundation for measurement of the performance rates for groups of physicians subject to the value-based paym ent modifier. Several commen ters, however, suggested using one PQRS reporting mechanism (rather than multiple mechanisms with varying criteria for1165 becoming a satisfactory reporter for the PQRS incentive payment. They cited “significant problems when comparing data submitted via claims-based CPT II codes and data gathered from an EHR data submission vendor or a registry” du e to the difference in reporting requirements. Response : We appreciate the commenters’ suggesti ons. We agree with commenters who stated that we should seek to align quality re porting mechanisms across physician programs. We intend to use the PQRS as the foundation for the va lue-based payment modifier. We also believe that if a group of physicians s ubject to the value-based payment modifier reports data for quality measurement using one of the available report ing mechanisms under the PQRS, then we should use performance on those quality measures for the value-based payment modifier. Thus, the PQRS reporting mechanisms available to groups of physicians subjec t to the value-based modifier will be available for these groups to report measures for purposes of the value-based payment modifier. Although we proposed to incl ude four methods for groups of physicians to participate in the PQRS GPRO (w eb-interface, claims, registries, and EHRs), as discussed in section III.G (Table 92), we are finalizing for the PQRS the web-interface and registries methods for CY2013. Thus, to align with the PQRS, we will finalize the same reporting methods for the value-based payment modifier. We recognize co mmenters’ concern about the comparability of performance rates on measures reported through di fferent reporting mechanisms. We intend to examine this issue more fully, especially as more physicians and groups of physicians utilize EHRs, to determine whether we should ad just our policies in future rulemaking. In summary, we are finalizi ng and clarifying our proposal th at the groups of physicians subject to the value-based payment may utilize the PQRS GPRO reporting mechanisms available to them in Tables 92, as well as the PQRS ad ministrative claims option as a group, for purposes of the value-based payment modifier. In addition, if physicians in a group of physicians subject to the value-based payment modifier wish to repo rt data for quality measures in the PQRS as1166 individuals for the PQRS payment incentive rather than as a group practice, th e group must elect the PQRS administrative claims-based reporti ng method as a group by October 15, 2013 in order for the group to avoid the -1.0 percent downward value-based paym ent modifier adjustment. (2) Quality Measure Alignment with the PQRS We proposed to include all i ndividual measures in the PQRS GPRO web-interface, claims, registries, and EHR reporting mechan isms for 2013 and beyond for the value-based payment modifier. We proposed to include the measures in the PQRS administrative claimsbased reporting option as well (77 FR 44998). We also proposed that four of the quality measures in the PQRS administrative claims-bas ed reporting option (the four outcome measures) be used in the value-based payment modifier fo r all groups of physicians subject to the valuebased payment modifier (77 FR 45001-02). Fina lly, we solicited comments on the quality measures that we should propose for individual physicians if we were to provide individual physicians the ability to elect to have the value-based payment modifier apply to their payments under the PFS starting in 2015 or 2016 (77 FR 44998). In addition, we sought comment on the inclusion of community level measures in th e value-based payment modifier (77 FR 45002).
Comment : The majority of commenters apprecia ted the flexibility of choice in reporting individual measures. The clin ical community cited that allo wing physician groups to report on the entire spectrum of PQRS measures “recogni zes the diversity of services provided among physicians and physician groups and allows for more appropriate assessments of quality.” Other commenters objected to the PQRS system becau se groups can “cherry pick” measures and consequently felt that PQRS did not provi de a strong enough incentive for improving performance. A couple of commenters did no t support including all measures from the 2013 GPRO interface in the value-base d payment modifier and suggested we exclude both measures new to the GPRO web interface and measures wh ich were not NQF-endorsed for physicians or1167 group practices. One of these commenters also expressed concern about measures in the web interface with absolute thresholds and measures that do not allow a clinician to indicate that a patient has declined the service. Other commenters cited a lack of measures for many specialties and sub-specialties within PQRS as a cause fo r concern in using performance rates from PQRS quality measures in 2015. Response : We agree with the majority of comment ers that physician groups should have flexibility in which measures to report for the value-based payment modifier. We are finalizing all of the individual measures under the PQRS for 2013 and beyond for the value-based payment modifier. These measures are discussed in Tables 94, 95, 123, and 124 in section III.G above. We disagree with the commenters’ suggestion to exclude measures new to the GPRO web interface, measures which were not NQF-endorse d, measures with absolute thresholds, and measures that do not allow a clinician to indicat e the patient has declined the service in the value-based payment modifier. We believe we have provided groups of physicians with sufficient flexibility to choose the quality reporting method as well as the measures on which to report information. Moreover, we reiterate that the quality-tiering electi on we are finalizing is optional, thus ensuring no payment consequen ces for potentially poor performance on such quality measures. In addition as we described above in secti on III.G.6, we plan on expanding the specialty measures available in the PQRS in order to mo re accurately measure th e performance on quality of care furnished by specialists. The expansion of the GPRO to registries in 2013 and to EHRs in 2014 means that sub-specialists may participate in the PQRS as members of a group practice, such that the group can report data on measur es of broad applicabil ity. We believe group reporting can ameliorate the commenters’ concerns that the current set of PQRS measures does not capture all of the clinical care that some sp ecialists and sub-specialists furnish. We also1168 recognize that the rules governing the PQRS are flexible in te rms of the quality measures physicians and groups of physicians report a nd the methods by which they report them. Although some commenters stated th is flexibility would lead to “cherry-picking” measures, we believe these two features of the PQRS are beneficial given that the first principle governing the value-based payment modifier is to encourage greater reporting of information for quality purposes by physicians and groups of physicians.
Comment : CMS received many comments about how to phase-in the value-based payment modifier at the individual level (for example, a solo pract itioner) to allow them to report measures within any of the PQRS mechanisms for individual reporting (claims, registry, EHR) or by the method they had systems in place to report. Commenters supported the idea of flexibility of choice in reporti ng measures as stated above. Response : The vast majority of commenters have agreed with the application of the value-based payment modifier at the group level for the initial implementation of the program. We are not finalizing an option for solo practitio ners to participate in the value-based payment modifier for 2015. We plan to make proposals fo r how the value-based payment modifier would apply to individual physicians and to sm aller groups in future rulemaking. d. Cost Measures Section 1848(p)(3) of the Act requires us to evaluate cost s, to the extent practicable, based on a composite of appropriate measures of costs. In the CY 2012 PFS final rule with comment period (76 FR 73434), we fina lized use of total per capita cost measures and per capita cost measures for beneficiaries with four specific chronic conditions (chronic obstructive pulmonary disease, heart failure, coronary arte ry disease, and diabetes) for the value-based payment modifier. Total per capita costs include payments under both Part A and Part B. Total per capita costs do not include Medicare paym ents under Part D for drug expenses. We1169 proposed to use at least a 60-day claims run out with a completion factor from our Office of the Actuary (for example, claims paid through March 1 of the year following December 31, the close of the performance period) to calculate the total pe r capita cost measures (77 FR 45002). As described more fully in the composite scoring methodology disc ussion below, we proposed to make cost compar isons among groups of physicians using a similar beneficiary attribution methodology such that we make “apples to apples” compar isons. We believe that this would be an appropriate approach to using the total per capita cost measure in the value-based payment modifier. We sought comment on these proposals. The following is a summary of the comments we received regard ing these proposals.
Comment : A number of commenters expressed support for CMS’ proposal to implement the total per capita cost measure and per capita co st measures for the four chronic conditions. One commenter noted that the four chronic conditions align with the proposed quality measures. Some commenters who expressed support for the proposed cost measures encouraged CMS to refine and improve its cost measures in a transparent manner, including by working with specialty societies and other intere sted parties to fine tune the existing meas ures and potentially add other chronic conditions. One commenter encouraged CMS to continue looking into how to incorporate Medicare Part D data into physician cost measures. One commenter expressed concerns that the value-based payment m odifier was based on “crude” per capita measures, while a number of specialists expressed concern that the cost measures are inappropriate for some specialties , particularly single sp ecialty practices. A number of specialists objected to basing phys ician cost measures on total amount billed per patient, since the specialist is assumed to be he ld responsible for care a nd treatment decisions of the patient for which they have little control a nd for which they have lim ited ability to modify their practice to reduce costs. Co mmenters indicated that attributi on of no costs or little costs to1170 specialists is possible under any attribution method since the major ity of specialists do not treat one of the four chronic conditi ons, so measuring costs using per capita measures would not create incentives to change be havior. Some commenters stat ed that Medicare Part A costs should be excluded from cost comparisons, b ecause physicians cannot control Part A (for example, hospital) costs. A number of sp ecialists supported CMS working closely with physicians to refine the cost measures prior to implementation of the value-based payment modifier. Response : In the CY 2012 PFS final rule, we estab lished a policy to use total per capita cost measures and per capita cost measures for beneficiaries with four specific chronic conditions (COPD, coronary artery disease, di abetes, and heart failure) in the value-based payment modifier to be implemented in 2015. We continue to believe that these measures are useful measures of the total volu me of healthcare services furn ished to Medicare beneficiaries attributed to a group of physicians . Moreover, use of total per capita cost measures reinforces one of the five principles governing implementa tion of the value-based payment modifier to encourage shared accountability for beneficiary care. We agree with specialty societies and other interested parties that suggested we con tinue to look for ways to refine the current measures and potentially add other chronic c onditions. We will continue to explore the feasibility of including Part D data in the cost measures.
Comment : Many commenters suggested that CMS focus on episode-based cost measures in the value-based payment modifier, and some explicitly mentioned the importance of CMS’ work related to development of the Medicare Episode Grouper. A number of commenters agreed with CMS’ recommendation to first incor porate episode costs from the Medicare Episode Grouper in the Physician Feedback program prior to applying the measures to the value-based payment modifier. Some commenters recommende d that CMS focus on chronic or high priority1171 episode types during the initial states of th e value-based payment modifier. Commenters suggested that CMS meet with specialty groups a nd other stakeholders to obtain feedback on the development and application of the Medicare Episode Grouper data and urged transparency through means other than just rulemaking. Response : We agree with commenters about the potential value of episode-based cost measures in the value modifier, and we also ag ree with those that suppo rt our recommendation to first incorporate episode costs from the Medicare Episode Grouper in the Physician Feedback program before applying these measures to th e value-based payment modifier. CMS plans to engage stakeholders through even ts that will provide details of the episode grouper methodology and to obtain feedback on episode based costs an d utilization.
Comment : Several commenters noted that it wo uld be useful to look at costs over a sufficiently long time period (for example, several y ears) to ensure that the full benefits of using the technology, diagnostic testing, or drug were ca ptured. Some commenters also noted that per capita cost measures do not reflect savings in Medi care Part A that are due to the physician’s or groups’ care. Other commenters suggested th at cost measures should be aligned with appropriate outcomes or quality measures. Response : We agree that it would be useful to incorporate benefits of technology and drugs that might be realized in future years, and we may examine ways to measure costs, and changes in cost, over multiple years in the future for the value-based payment modifier. We believe that Part A savings during the performance year will be reflected in lower total per capita costs, and thus we disagree with the comments that suggest we s hould not include Part A costs in the total per capita cost measures.
Comment : A number of commenters recommen ded that all value-based payment modifier cost measures be submitted to NQF fo r endorsement. Some commenters stated that1172 CMS should include only NQF-endorsed cost measur es in the value-base d payment modifier. They also suggested that CMS delay implementa tion of the value-based payment modifier until measure testing and the NQF process was complete. Response : We plan to submit the total per capita cost measures and the four chronic condition-focused per capita measures for NQF endorsement. Although we generally agree that NQF-endorsed measures are preferable, we do not agree that we should only use NQF-endorsed measures for the value-based payment modifier. The development of cost measures is in its infancy and we believe that conditioning use of cost measures for the value-based payment modifier on NQF-endorsement would unduly delay implementation of the value-based payment modifier.
Comment : We received no comments specifically on using at least a 60-day claims run out, but one supporter of the five per capita cost measures noted th at the run out period should be established such that an extension of the time period would only minimally improve accuracy. Response : We are finalizing our proposal to us e at least a 60-day run out with a completion factor from CMS’ Office of the Actuary to calculate the total per capita cost measures, because we believe it will provide an accurate calculation of these measures. As a result of the comments and for the r easons we articulated previously, we are finalizing the total per capita cost measures and per capita cost measures for beneficiaries with four specific chronic conditions (C OPD, coronary artery disease, diabetes, and heart failure) in the 2015 value-based payment modifier and to use at least a 60-day claims run out. (1) Proposed Payment Standardization Methodology for Cost Measures
Section 1848(p)(3) of the Act requires that “...costs shall be evaluated, to the extent practicable, based on a composite of appropriate measures of co sts established by the Secretary (such as the composite measure under th e methodology established under section1173 1848(n)(9)(C)(iii)) that eliminat e the effect of geographic adjustments in payment rates (as described in subsection (e))...” We have interprete d this directive to require us to standardize Medicare payments to ensu re fair comparisons of co sts across geographic areas. Payment standardization removes local or regi onal price differences that may cause cost variation a physician cannot influence through pr acticing efficient care. In Medicare, an effective payment standardization methodology w ould exclude Medicare geographic adjustment factors such as the geographic practice cost inde x (GPCI) and the hospital wage index so that, for example, per capita costs for beneficiaries in Atlanta, Georgia can be compared to those of beneficiaries in Lincoln, Nebraska. Payment standardization, th erefore, allows fair comparisons of resource use costs for physicians to those of peers who may practice in locations or facilities where Medicare payments are higher or lower. With industry input, we developed a Medica re payment standardization methodology that excludes such geographic payment rate differenc es. We update this methodology annually to reflect any change in CMS payment systems. We proposed to use the same standardization methodology as in the 2011 Physician Feedb ack reports and the Medicare Spending per Beneficiary (MSPB) measure that is used in CMS’ feedback re ports to hospitals (77 FR 45003). The following is a summary of the comment s we received regarding the payment standardization proposal.
Comment : Commenters expressed support for removing geographic and other adjustments when calculating cost measures. Seve ral commenters agreed that cost measures in the value-based payment modifier must be standa rdized and explicitly supported the removal of indirect medical education (IME) and disproportionate share hosp ital (DSH) payments from the inpatient resource calculations. Multiple commenters expressed concern about the Geographic Price Cost Indices1174 (GPCIs). They stated that the GPCI results in downward adjustments that do not reflect the actual cost of physician practice. Some commenters referred to concerns about CMS cost measurement methodology issues that were rais ed in the May 2011 and July 2012 Institute of Medicine reports that questioned CMS po licies regarding geographic adjustment. 5 These commenters claimed that, although the standardiza tion method reverses the effects of the GPCI, it results in the perpetuation of some of the inacc uracies of the GPCI inputs that reduce payments for some regions. Some commenters stated that payment standardization does not account for regional differences in spending, so CMS should establish cost m easures at the regional and national level. One commenter described con cerns about efforts of poor physician supply on local cost measures. Several commenters noted that some areas might have high costs but lower rates of spending growth than nationally. Response : We agree that standardization is important to ensure that groups of physicians’ cost measures are not higher or lo wer due to geographic differences and other adjustments (IME, DSH, etc.) that affect actual Medicare Part A and Part B payments. We note that the effects of the GPCIs are rem oved from payments under the CMS payment standardization methodology, 6 so services that would be subject to the GPCIs under Medicare payment rules are priced at the same level across all physicians within the same setting, regardless of geographic area in which they practice. Commenters’ concerns about the effectiveness of our geographic adjustment policies in general are outside the scope of this rulemaking. Commenters’ concern about the pr oposed standardization methodology not taking account of regional differences in spending a ppears to misinterpret our approach to

5 See http://iom.edu/Reports/2011/Geographic-Adjustment-in- Medicare-Payment-Phase-I- Improving-Accuracy.aspx (May 2011; revised September 2011) and http://iom.edu/Reports/2012/Geographic-Adjustment-in-MedicarePayment-Phase-II.aspx (July 2012). 6 See Quality Net, Measure Methodology Reports, available at: http://www.qualitynet.org/dcs/ContentServer?c=Page&p agename=QnetPublic%2FPage%2FQnetTier4&cid=122877 2057350

.1175 standardization. The per capita cost measures themselves will show regional differences in Medicare spending, but the standard ization process ensures that differences in cost measures do not reflect differences in Medicare ’s price indices such as the GP CI. Finally, standardization is not meant to measure growth in spending. As a result of the comments and for the reas ons specified above, we are finalizing our proposal to apply the CMS paym ent standardization methodology, a nd any annual updates to the methodology, to the cost measures used for the value-based payment modifier. (2) Risk Adjustment Methodology for Cost Measures Section 1848(p)(3) of the Act re quires that costs be adjusted to “...take into account risk factors[,] such as socioeconomic and demographic characteristics, ethnicity, and health status of individuals (such as to recogni ze that less healthy individual s may require more intensive interventions) and other factors determined appropriate by the Secretary.” Risk adjustment accounts for differences in patie nt characteristics not directly related to patient care, but that may increase or decrease the costs of care. In the Physician Feedback reports, after standardizing per cap ita costs for geographic factors, we also adjusted them based on the unique mix of patients attr ibuted to the physician or group of physicians. Costs for beneficiaries with high risk factor s (such as a history of chronic di seases, disability, or increased age) are adjusted downward, and costs for benefi ciaries with low risk factors are adjusted upward. Thus, for individual physicians or phys ician groups who have a higher than average proportion of patients with serious medical conditi ons or other higher-cost risk factors, risk adjusted per capita costs are lo wer than the unadjusted costs, because costs of higher-risk patients are adjusted downward. Similarly, for individual physicians or physician groups who treated comparatively lower-risk patients, risk adjusted per capita costs were higher than unadjusted costs, because costs for lower-risk patients were adjusted upwards.1176 We proposed to use the HCC model, which a ssigns prior year ICD-9-CM diagnosis codes to 70 high-cost clinical conditions (each with similar dise ase characteristics and costs) to capture medical condition risk (77 FR 4500 3-45004). The HCC risk scores al so incorporate patient age, gender, reason for Medicare eligibil ity (age or disability), and Me dicaid eligibility status, which is in part a proxy for socioeconomic status and reflects the greater resources typically used by beneficiaries eligible for both Me dicare and Medicaid. The risk adjustment model also includes the beneficiary’s end stage renal disease (ESRD) status. More information about the risk adjustment model is on the CMS website at http://www.cms.gov/Medicare/Medicare-Fee-forService-Payment/PhysicianFeedbackProgram /Downloads/122111_Slide_Presentation.pdf

. We proposed to use the same risk adjustment model for risk adjusting total per capita costs and the total per capita costs for beneficiar ies with four chronic diseases (coronary artery disease, COPD, diabetes, and heart failure) as we have used for the group and individual 2010 Physician Feedback reports. The following is a summary of the comments we received regarding the risk adjustment proposal.
Comment : A number of commenters supported the HCC risk adjustment methodology, with one commenter stating that the risk adjustment approach that was used for the 2010 physician feedback reports is the best currently available approach to risk adjustment of the value-based payment modifier with the best proxies for health st atus and socioeconomic status being used. Other commenters no ted the need for or importance of risk adjustment of cost measures without explicitly stating support of the CMS met hod, with one commenter urging CMS to proceed with caution so that risk adju stment does not penalize physicians that treat sicker, more costly patients. Many commenters expressed concerns about th e proposed risk adjustment method. Some1177 commenters indicated that they had long-standing concerns with the HCC risk adjuster that should be addressed before the value-based paymen t modifiers is applied to small and mid-sized practices, and they urged CMS to consider ne w approaches that have been suggested by MedPAC and by the Medicare Episode Grouper c ontractor. Some con cerns about the HCC model that commenters expressed in clude that it does not fare as well with acute costs associated with surgeries that are not predictable. Some commenters argued that so cioeconomic factors and compliance are not adequately captured in the mode l, and that the Medicaid dual eligible status alone does not capture these differences in ri sk. Commenters suggest ed including different factors to capture socioeconom ic status, including poverty st atus, education, literacy, race, ethnicity, English proficiency, homelessness, and religion. A number of commenters urged that CMS do further analysis in testi ng and refining risk adjusters that address comorbid conditions or new disease onset, and suggested that CMS work with physician groups. Response : We continue to believe that the cu rrent risk adjustment methodology, which is based on the HCC model 7 and supported by a number of commenters, should be used in the value-based payment modifier. The HCC model is calibrated on Medicare fee for service beneficiaries and is accurate in predicting these co sts. Moreover, one of the benefits of the HCC model is that CMS updates it regularly to reflect changes in treatment patterns and costs. In addition, CMS is exploring how to incorporate additional asp ects of coding completeness and quality. The result of these efforts would inform how to weigh the future model design to predict costs and to capture conditions that are present in clinical conditions. 8 Commenters did not present evidence that the risk adjustment model systematically

7 See RTI, ``Evaluation of the CMS-HCC Risk Adjustment Methodology,'' (March 2011), available at: https://www.cms.gov/MedicareAdvtgSpecRateStats/downloads/Evaluation_Risk_Adj_ Model_2011.pdf

. 8 See “Advance Notice of Methodological Changes for Ca lendar Year (CY) 2013 for Medicare Advantage (MA) Capitation Rates, Part C and Part D Payment Policies and 2013 Call Letter.”1178 disadvantages physicians or groups that see certain patient types, nor did they present reliable data sources we could use in our risk adjustme nt model to account for recommended factors such as socioeconomic status, education, literacy, E nglish proficiency, homelessness, and religion. We agree with commenters that patient complia nce could be a relevant issue, but commenters did not present a method about how to incorporat e such compliance into the risk adjustment model using existing beneficiary data. After consideration of the comments and for the reasons discussed above, we are finalizing our proposed approach to risk adjustment of the cost measures included in the valuebased payment modifier. e. Attribution of Quality and Cost Measures Calculation of administrative claims-based quality and cost measure performance rates requires us to attribute Medicare beneficiaries to groups of phys icians. We proposed to use a plurality of care method to attrib ute beneficiaries to a group of phys icians (77 FR 45005). In this method, we attributed Medicare FFS beneficiaries to the group practi ce that billed a larger share of office and other outpatient Evaluation and Mana gement (E/M) services (based on dollars) than any other group of physician practice (that is, the plurality). In addition, beneficiaries had to have at least two E/M services fu rnished by the group of physicians.
We sought comments on two possible alterna tive attribution approaches for the valuebased payment modifier (77 FR 45005). First, we sought comment on whet her we should use an attribution approach based on th e methodology used in the Medicare Shared Savings Program to assign a beneficiary to an Acc ountable Care Organization (ACO). As discussed in the CY 2013 proposed FFS rule (77 FR 44819), this attribution approach would involve a two-step process that emphasizes primary care services furnishe d by a physician or group of physicians. Second, we sought comment on whether we instead should apply the “degr ee of involvement” attribution1179 method. We used the “degree of involvement” method to attribute beneficiaries for cost purposes to individual physicians in the CY 2010 Physician Feedback reports. Under this attribution method, we classified the patients for which a physician submitted at least one Medicare FFS Part B claim into three categorie s (directed, influenced, and contributed) based on the amount of physician involvement with the patient. 9 For directed and influenced patients, the physician billed for 35 percent or more of the patie nt’s office or other ou tpatient evaluation and management (E/M) visits or for 20 percent or mo re of the patient’s total professional costs, whereas for contributed patients, the physician billed for fewer th an 35 percent of the patient’s outpatient E&M visits and for less than 20 percen t of the patient’s total professional costs.
The following is a summary of the comments we received regarding the attribution proposal.
Comment : We received several comments on attribution. Of the many commenters who expressed a preference for one of the attribution methods, the majo rity expressed support for the plurality of care method or the pl urality of primary care services method used in the Medicare Shared Savings Program (Shared Savings Program). Arguments in favor of a plurality of care attribution method include consistency with 2010 group feedback repo rts, administrative simplicity, transparency, credibil ity, understandability, and its emphasis on role of treatment of chronic conditions. One commenter supported usi ng a plurality of care method, but stated that CMS should encourage beneficiaries to choose a primary care physician and adopt an attribution method that includes greater consideration of annual wellness visits. Another commenter suggested that CMS adopt either a plurality of care or pluralit y of primary care services as included in the Shared Savings Program, as it w ould provide a better tr ansition to episodes of

9 CMS, “Detailed Methodology for Individual Physician Reports” (2012), available at http://www.cms.gov/Medicare/ Medicare-Fee-for-ServicePayment/PhysicianFeedbackProgram/Download s/QRURs_for_Individual_Physicians.pdf1180 care than the degree of involvement method. Although commenters were more favorable of the plurality of care or plurality of primary care method than the degree of involvement a ttribution method, some commenters expressed concerns about using an attribut ion method based on plurality of car e. Some commenters agreed with CMS that the plurality of care method, which depends on E/M frequency, would not work for certain specialists, with one commenter stati ng that plurality unfairly attributes costs to certain specialties over others and other commenters agreeing with CMS that plurality will not be applicable to single specialty groups. One co mmenter expressed concern that the plurality method may be too restrictive for some practices . Another commenter noted that plurality of care attribution in the performance year is a probl em when used with risk adjustment that is based on claims that are submitted in years prior to the performance year, and noted that multiple attribution or degree of involvement may alle viate some, but not all, of the issues. One commenter asked how the plural ity of care method accommodates specialists who do not furnish the plurality of a patient’s care. CMS asked for comment on the plurality of pr imary care attribution approach that is similar to what is used in the Shared Savings Program. Although fewer commenters discussed this method than the plurality of care method, most who did discuss this method expressed general support for this approach, either as their preferred attri bution method or one that was at least at the same level of acceptability as the plurality of care method. Some commenters stated that, while the plurality of care method would be consistent with the attribution method proposed for the PQRS GPRO web-interface, the plural ity of primary care attribution method is comparable to that used in the Shared Savi ngs Program and would cr eate consistency across these programs. One specialist group indicated that a patient that sees a specialist for management of chronic conditions and receives a plurality of primary care services from the1181 specialist would be appropriately attributed under this method. One medical center supported the Shared Savings Program-like approach over th e plurality of care method because most group reporting measures are primary car e based, so attribution under this method would be to the primary care physician whereas, under plurality of care attribution, the beneficiaries could be assigned incorrectly to higher cost specialists. Response : We are persuaded by the comments that we should not finalize the plurality of care method, but should instead align the attri bution methodology with the methodology used for the Shared Savings Program. Given that we ar e applying the value-based payment modifier to groups of physicians of 100 or more eligible prof essionals, we believe it is important to align attribution methods with the one being used fo r the Shared Savings Program and the PQRS. Because the cost measures we are using for the value-based payment modifier focus on total per capita costs, we believe it is reasonable to attr ibute beneficiaries to those groups of physicians that are most responsible for the delivery of primar y care services and have the ability to furnish it in a cost-effective manner. We recognize that certain large single sp ecialty groups – such as those limited to emergency medicine, diagnostic radiology, pathology, and anesthesiology – will not be attributed beneficiaries under this attributi on methodology. Indeed, neither the plurality of ca re attribution methodology nor the Shared Savings Program me thodology would attribut e beneficiaries to certain single specialty groups. However, after we have had the opportunity to examine the issue further and gain more experience with the value-based payment modifier we anticipate addressing this issue in future rulemaking. We belie ve that as we continue to phase in the valuebased payment modifier, we will refine our attrib ution methods to assign beneficiaries to these physicians and groups of physicia ns within these specialties.
Comment : Support for the degree of involvement method was mixed, with a high1182 percentage of commenters of this method suggest ing that it needed to be studied further and explained to physicians. Some commenters argued that the de gree of involvement method was more comprehensive and a better alternative in th e long run; allows physicians who contribute to the care of a patient to be recognized for thei r services; and is preferable for attribution for individual physicians (rather th an groups). One commenter suppor ted the degree of involvement method, but disagreed with the idea of combining the directed and influenced categories because of the differences in accountabi lity between the two categories. Similarly, another commenter indicated that if CMS selected the degree of involvement met hod over its preferred method of plurality of care, only the directed category should be used, since influenced patients are not sufficiently under the physicians’ care. Anot her commenter suggested that CMS study the effects of the degree of involvement method and c onsider whether to excl ude certain specialists from attribution because they should not be treating patients with certain conditions. A number of commenters expr essed either concern or c onfusion about the degree of involvement attribution method. Several commenters suggested that CMS use data from the Physician Feedback reports to examine the im pact of different methods on groups’ cost and quality scores. Some commenters questioned ho w the degree of involvement classification would translate into how much would be attributed to a physic ian or a group. One commenter indicated that the degree of involvement met hod would be problematic in many cases and would need to evolve over time, with considerati on for physicians who see patients at multiple facilities. Emergency physicians expressed concer n about their ability to influence overall costs through coordination, although they might be attributed the costs under this method. Response : We thank commenters for their views on the degree of involvement attribution methodology, but as di scussed above, we are finaliz ing the attribution methodology used in the Medicare Shared Savings Program. We will continue to study this methodology for1183 it may continue to have applicab ility when we make proposals to apply the value-based payment modifier to individual physicians.
Comment : Some commenters expresse d concerns about attribution methods in general, stating that the current models do not address attribution appropriately when a patient sees multiple physicians, with some costs within a phy sician’s control and other costs not within the physician’s control. Another commenter sugges ted that CMS explore the option of a set of billing codes to make explicit the scope and na ture of responsibility between the physician and patient. Another commenter indi cated that attribution methods for specialists must account for care furnished because the original physician did not take sufficient preventive steps or because the patient was referred to a specialist. One commenter stated that attribution of the entire cost of surgeries should be attributed to the performing surgeon. Response : We thank commenters for their vi ews and will consider them when developing future proposals to design an attr ibution methodology for t hose groups of physicians that will not have beneficiaries attributed to them under the finalized attribution methodology discussed above for the 2 013 performance period.
Comment : Many commenters indicated that CMS should study the impact of different attribution methods on physicians /physician groups’ costs and sh are the results to solicit stakeholder feedback, possibly through future ru lemaking. A number of commenters expressed a willingness to work with CMS on attribution. Co mmenters wanted to understand how the results change when the attribution methodology change s, and some suggested that CMS delay the value-based payment modifier unt il CMS has tested and implemented a meaningful system for attribution to specialists. Some commenters di scussed the RAND study to prove their point that the attribution methodology can affect how physicians and groups of physicians are characterized for cost and quality purposes. Th is study, which used clai ms on adults age 18-651184 that were continuously enrolled in four Massach usetts commercial plans in the years 2004 and 2005, created 12 attribution rules and found that about 22 percent of physicians would be assigned to the wrong cost category gi ven a change in attribution rules. 10 Response : We agree with commenters that it w ould be informative to study the results of different attribution methods using the same data and share the results with physicians. We do not agree with the commenters’ suggestion to de lay implementation of the value-based payment modifier. We believe it is critical for physicia ns and groups of physicians to report data for quality measures through the PQRS. A delay of the value- based payment modifier would undermine this objective. Moreover, because the quality-tiering calculation methodology is optional, we believe we have provided a reasona ble way to implement the value-based payment modifier so that groups of physicians can obt ain information on how their payment could be modified in the future and take appropriate action. As a result of the comments, we are not finalizing the proposed plurality of care method, but instead, as described above, we will apply the same attribution rule as that used for the Medicare Shared Savings Program and the PQ RS GPRO web interface. This methodology is described at http://www.gpo.gov/fdsys/pkg/FR-2011-11-02/pdf/2011-27461.pdf . See also 45 CFR 425.400 through 425.402. f. Composite Scores for the Value-Based Payment Modifier Section 1848(p)(2) of the Act requires that quality of care be evaluated, to the extent practicable, based on a composite of measures of the quality of car e furnished. Likewise, section 1848(p)(3) of the Act requires that costs in the value-based paymen t modifier be evaluated, to the extent practicable, based on a composite of appropriate measures of costs. (1) Quality of Care and Cost Domains

10 See RAND, Is Physician Cost Profiling Ready for Prime Time? Available at: http://www.rand.org/pubs/researc h_briefs/RB9523-1/index1.html1185 We proposed to align the quality measures used in the value-based payment modifier with the national priori ties established in the National Quality Strategy (77 FR 45006). The National Quality Strategy outlined six priorities including:

● Make care safer by reducing harm caused in the delivery of care (patient safety).

● Ensure that care engages each person and family as partners (patient experience).

● Promote effective comm unication and coordination of care (care coordination).

● Promote the most effective prevention a nd treatment practices for leading causes of mortality (clinical care).

● Work with communities to promote wide us e of best practice to enable healthy living (population/community health).

● Make quality care more affordable for individuals, families, employers, and governments by developing and spreading new health care delivery models (efficiency). 11 We proposed to classify each of the quality measures that we proposed for the valuebased payment modifier into one of these six domains. We proposed to weight each domain equally to form a quality of care composite. We be lieve this is a straightforward approach that recognizes the importance of each domain. Within each domain, we proposed to weight each measure equally so that groups of physicians have equal incentiv es to improve care delivery on all measures. To the extent that a domain does not contain quality measures, the remaining domains would be equally weighted to form the quality of care composite. For example, if only three domains contain quality information, each domain would be weighted at 33.3 percent to form the quality composite while the remaining three domains would not be included. In terms of the cost composite, we finaliz ed in the CY 2012 PFS final rule (76 FR 73434) five per capita cost measures: total per capita co sts (Parts A and B) and total per capita costs for

11 National Quality Strategy, http://www.healthcare.gov/law/resources/rep orts/nationalqualitystrategy032011.pdf

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beneficiaries with four chronic diseases (diabetes, CAD, COPD, heart failure). We proposed to group these five per capita cost measures into tw o separate domains: total overall costs (one measure) and total costs for beneficiaries with sp ecific conditions (four me asures). A separate domain for costs for beneficiaries with specific conditions highlights our desire to incentivize efficient care for benefici aries with these conditions. Similar to the quality of care composite, we proposed to weight each cost domain equally to form the cost composite and within the cost domains we proposed to weight each measure equally. In those instances in which we cannot ca lculate a particular cost measure, for example, due to too few cases, we proposed to weight the remaining cost meas ures in the domain equally.
Comment : We received comments both in support of and in opposition to our proposed composite score methodology. Some commenters e xpressed support for quality of care and cost composites, with one noting their view that comp osite scores are more meaningful for purchasers than are other measures. Some commenters e xpressed concerns with the proposed composite measures. For example, one commenter observed that quality of care and cost composites might mask significant variation in pe rformance across disease categorie s. That is, a physician could demonstrate high quality and low costs for one disease category, but lower quality and higher costs for others; however, this would not be de tected within a composite measure. This commenter also recommended that the internal validity of measures should be demonstrated before multiple measures are combined into a single composite. Another commenter expressed concern that few measures within the composites were applicable to their particular specialty. Comments on our proposed domains and we ighting methodology were also mixed. One commenter expressed support for our proposal to equally weight domains, but recommended that attention be given to the number of measures in each domain so that they were weighted to support our policy goals. Another commenter e xpressed concern about establishing separate1187

domains when some of these had no measures in place (for example, population/community health) while others had only a handful of measures, which coul d cause differential weighting
among measures. We also received varying views on how to weight various measures. One commenter suggested that quality outcome m easures should receive more wei ght than other measure types; another comment suggested that outcome measures be weighted lower than the PQRS measures as the latter are likely to be more direct indicators of a physicia n’s performance, particularly for specialty physicians. Alternatively, one commen ter suggested that CMS weight existing PQRS measures within the efficiency domain for thos e who successfully report or assess costs on a measure-by-measure basis. Response : We appreciate the comments in supp ort of, and suggestions to improve upon, our proposals. We believe that forming each gr oup of physicians’ quality and cost composites by equally weighting quality meas ures in equally weighted domains makes the most sense when groups of physicians have flexibility to choose wh ich measures they will report. It also is a transparent method and easily understood by physic ians. We recognize that some groups may not report measures in certain proposed dom ains, such as community/population health, efficiency, and patient experience. We wish to clarify that our proposal intended to establish an overall framework for how we would weight measur es, and that as more measures are included in this and the PQRS programs, they would be inco rporated into our framew ork. As we stated in the proposed rule (77 FR 45006), in cases where a group does not report measures in one or two of the domains the remaining domains will be weighted equally. If the group only reports measures in a single domain, the domain would be weighted 100 per cent. Moreover, all measures in a domain would be equally weighted. We agree with the commenters’ recommenda tion that we continue to monitor and1188 examine our policy to form the quality and cost co mposites. We believe this monitoring will be facilitated with the data reporte d by those participating in value- based payment modifier and the PQRS programs. As part of this monitoring, we will be able to examine whether the quality and cost composites are masking performance va riation within a group as suggested by the

commenters. Accordingly, we are finalizing our proposal to construct the quality composite by classifying each group’s quality measures into on e of the six National Qual ity Strategy domains, to weight each measure equally within each domain, and to weight the domains equally to form the quality composite. Likewise, we are finalizing our proposals to construct the cost composite by classifying each group’s per capita cost meas ures into two domains – all patients and all patients with four specific chronic conditions, to weight each measure equally within each domain, and to weight the domains e qually to form the cost composite. (2) Value-Based Payment M odifier Scoring Methods We proposed a scoring approach that focuses on how the group of physicians’ performance differs from the benchmark on a measure-by-measure basis because we proposed to provide flexibility to groups of physicians as to the quality m easures they report (77 FR 45007). We explained that the scoring methodology needs to be able to compare “apples to apples.” For each quality and cost measure, we proposed to divide the difference between a group of physicians’ performance rate and the benchmark by the measure’s standard deviation. The benchmarks, as further described below, are the na tional means of the quality or cost measure. This step produces a score for each measure th at is expressed in standardized units.
Comment : The comments we received on this i ssue supported our proposal to establish standardized scores for performance measures to ensure fair compar isons among groups of physicians.1189
Response : After consideration of the comments, we are finalizing our proposal to establish standardized scores for the value-based modifier pe rformance measures. We believe that this approach achieves our policy objective to distinguis h clearly between high and low performance and to allow us to create composite s of quality of care for groups of physicians that report different quality measures. We will be considering the effects of our methodology over the next several years as we implement this program and may consider changes to the policy through future rulemaking. (3) Benchmarks and Peer Groups for Quality Measures We proposed that the benchmark for each qual ity measure be the national mean of each measure’s performance rate during the performa nce period (77 FR 45008). We proposed to unify the calculation of the benchmark by weighti ng the performance rate of each physician and group of physicians submitting data on the quality measure by the number of beneficiaries used to calculate the performance rate so that gr oup performance is weight ed appropriately. In addition, we proposed that the benchmar ks for quality measures in the PQRS administrative claims-based reporting option be the national mean of each quality measure’s performance rate calculated at the TIN level. We proposed to calculate the national mean by including all TINs of groups of physicians with 25 or more eligible professionals. We proposed to weight the TIN’s performance rate by the number of beneficiaries used to calculate the quality

measure. To help groups of physicians understand how their quality measure performance affects their quality of care composite score, we proposed to publish th e previous years’ performance rates (and standardized scores) on each quality measure.
Comment : We received several comments suppor ting our proposed national benchmark. Some commenters highlighted thei r view that national benchmarks were a fair way to both (1)1190 reward high-quality, low-cost groups of physicia ns while (2) providing targets for improvement to underperforming groups of physicians. A lthough generally suppor ting our proposal, one commenter expressed the concern that benchmar ks might be skewed and inconsistent across years because physicians could choose the measures on which they reported rather than requiring that they report on the full distribution of performance. Accordingly, this commenter recommended that all groups of physicians should report on a common set of measures. Other commenters reported con cerns about the proposed nati onal benchmark and, as an alternative, suggested that comparisons should be within regions, physician or to some other appropriate peer group, for exampl e, considering patient risk. One commenter encouraged CMS to set performance standards higher in subsequent years. Some commenters suggested th at CMS explore and conduct analyses on a variety of benchmarking options. For example, one sugge sted that CMS examine the advantages of initially using a regional or bl ended benchmark that gradually moves to a national benchmark. In their view, this could be a means to enc ourage physician buy-in while not disadvantaging certain regions based on their hist orical performance levels. One commenter suggested that for a pay-for-per formance system to be effective, it must have clarity and credibility w ith front-line practitioners. Th is commenter observed that under our proposals, physicians receiving a payment ad justment are unlikely to understand why their payments are getting adjusted and what they need to do to improve their value modifier. Response : We appreciate the comments we receiv ed in support of our proposed national benchmarks as well as suggested alternatives. Given that Medicare is a national program, we concur with comments that a national benchmark is most appropriate. Medicare beneficiaries should receive high quality and low cost care re gardless of their location. Moreover, we use national benchmarks for other Me dicare programs aimed at impr oving the quality and cost of1191 care, for example, the Medicare Shared Savings program. Because we are allowing flexibility on the qua lity measures that groups of physicians can report, we believe the most appropriate peer group consists of othe r physicians and physician groups reporting the same measure regardless of specialty. Under this approach, we expect physicians and physician groups will report data on th e quality measures that best reflect the care they furnish. We also believe that the optional nature of the quality-tiering appr oach to calculating the value-based payment modifier wi ll encourage physician buy-in wh ile not disadvantaging certain regions based on their historical performance levels, thus we will not develop regional benchmarks for each quality measure. Further, we believe transparency is a ke y component to establish credibility among physicians, namely, physicians need to understand why their paym ents are being adjusted in order to improve their performance. Thus, we are modifying our proposal to establish benchmarks based on the year prior to the perfor mance year so that groups of physicians have information on national benchmarks prior to the e nd of the performance year. For example, the benchmark for the 2013 performance year will be based on 2012. We intend that these benchmarks would be available publicly to in form a group of physicians’ choice of PQRS reporting method for the applicable performance year. Accordingly, we are finalizing our proposal for national benchmarks and we will unify the calculation of the benchmark by weighting th e performance rate of each physician and group of physicians submitting data (through any PQRS reporting method) on the quality measure by the number of beneficiaries used to calculate th e performance rate. In addition, the benchmarks for quality measures in the PQRS administrativ e claims-based reporting option are the national mean of each quality measure’s performance rate cal culated at the TIN level. We will weight the1192 TIN’s performance rate by the number of beneficiar ies used to calculate the quality measure. We also will use the year pr ior to the performance year as the year for calculating the benchmark. If a measure is new to the PQRS, we will be unable to calculate a benchmark, and hence, performance on that measure will not be included in the quality composite. We will be considering the effects of our policies over the ne xt several years as we implement this program and may consider changes and refinements through future rulemaking. (4) Benchmarks and Peer Groups for Cost Measures To ensure fair cost comparisons that identif y groups of physicians that are outliers (both high and low), we proposed that the methodology used to attribut e beneficiaries to a group of physicians be the same as the methodology used to attribute beneficiarie s in the peer group (77 FR 45008). We explained that we seek to compar e like groups of physicians that use the same cost attribution methodology to ensure we ar e making “apples to apples” comparisons among groups of physicians. As discussed above, we ar e finalizing a cost attr ibution methodology that we use in the Medicare Shared Savings Program and that relies on a tw o-step process. We sought comment, however, on whether the cost measure peer groups should change if we adopted the “degree of involvement” methodology fo r groups of physicians other than groups of physicians using the PQRS GPRO web-interface to submit data on quality measures. We also solicited comments on establishing cost benchm arks on a quality measure-by-quality measure basis.
Comment : As discussed above, we received comments in support of our proposal for a national benchmark. We also r eceived several suggestions that we implement regional cost benchmarks rather than national ones to acc ount for regional variations in spending. Response : Consistent with our di scussion above regarding the national basis of this program, we are finalizing our proposal to esta blish national benchmarks for the five cost1193 measures based on data from the current perfor mance year. Given that we are standardizing Medicare payments to eliminate regional pa yment differences to ensure fair national comparisons, we do not believe it is appropriate to establish re gional benchmarks for the valuebased payment modifier. We will be considering the effects of this policy over the next several years as we implement this program and may cons ider changes to these policies through future rulemaking. (5) Reliability Standard We believe it is crucial that the value-based payment modifier be based on quality of care and cost composites that reliably measure performance. Statistical reliability is defined as the extent to which variation in the measure’s performa nce rate is due to variation in the quality (or cost) furnished by the physicians (or group of physic ians) rather than random variation due to the sample of cases observed. Potential reliability values range from zero to one, where one (highest possible reliability) signifies that all variation in the measure’s rate s is the result of variation in differences in performance across physicians (or gr oups of physicians). Generally, reliabilities in the 0.40-0.70 range are often considered m oderate and values greater than 0.70 high. Therefore, we proposed to establish a minimu m number of cases in order for a quality or cost measure to be included in the quality of care or cost composite (77 FR 45009). To the extent that a group of physicians fails to meet the minimum number of cases for a particular measure, the measure would not be counted and the remaining measures in the domain would be given equal weight. To the extent that we ca nnot develop either a reli able quality of care composite or cost composite because we do not have reliable domain information, we proposed that we would not calculate a value-based payment modifier and payment woul d not be affected. Based on an analysis of the individual CY 2010 Physician Feedback reports and on recent literature, we proposed a minimum case size of 20 for both quality and cost measures to ensure1194 high statistical reliability. We explained that the average reliability of the total per capita cost measure assessed at the individual le vel for physicians in all specialties was high (greater than 0.70) when the minimum case size was 20 or more. We also stated that reliability was high for nine of the 15 administrative claims based qual ity measures that we are proposing for purposes of the value-based payment modifier for the PQ RS administrative claims-based reporting option when the minimum case size was 20 or greater. We anticipate that statisti cal reliability of the quality and cost measures will increase when we assess physicians at the TIN level rather than NPI level, because, on average, a TIN will be attributed more beneficiaries than an NPI.
Comment : We received a few comments on this proposal expressing support for strong reliability standards or a minimum case size threshold. We received a couple of comments recommending a higher minimum case size, for ex ample, 30 rather than 20. One commenter sought clarification of our analys is of the reliability of the ad ministrative claims based quality measures from the 2010 Individual Physician Feedback reports. Response : We appreciate the comments we received in support of strong reliability standards. Based upon our statisti cal analysis that we discusse d in the proposed rule (77 FR 45009), we believe a minimum case size of 20 is suffici ent for this purpose. As we stated in our proposal, nine of the 15 administrative claims qu ality measures were highly reliable at the individual level. The other six were either mode rately reliable at the individual level or assessed clinical care in high priority areas. We anticipate that reliability will not be an issue given that our analysis was at the individua l level and not for groups of 100 or more eligible professionals. Accordingly, we are finalizing our proposal for 20 cases as the minimum case size; however, we will monitor and examine this issue as we implem ent this program and may consider changes to this policy through future rulemaking as we broa den the value-based payment modifier to reach all physicians and groups of physicians in 2017.1195 g. Payment Adjustment Amount Section 1848(p) of the Act does not specify the amount of physician payment that should be subject to the adjustment for the valu e-based payment modifier; however, section 1848(p)(4)(C) of the Act requir es the payment modifier be implemented in a budget neutral manner. Budget neutrality means that payments will increase for some groups of physicians based on high performance and decrease for othe rs based on low performa nce, but the aggregate amount of Medicare spending in any given year for physicians’ services will not change as a result of application of the value-based payment modifier. In making proposals about the amount of Medicare payment made under the PFS at risk for the value-based payment modifier, we c onsidered that there are two other payment adjustments affecting physicians’ Medicare payment in 2015 that could further decrease physician payments in 2016. Specifically, und er the PQRS, a physician who does not submit data on quality measures to meet the satisfa ctory reporting criteria for the PQRS payment adjustment during the applicable reporting pe riod in 2013 will have his or her fee schedule amount reduced by 1.5 percent for services furn ished in 2015. This PQRS downward payment adjustment to the fee schedule will increase to 2 percent in 2016 (and thereafter) based on reporting periods that fall in CY 2014 (and therea fter, reporting period or periods that fall two years prior to the year in which the PQRS paym ent adjustment is assessed). The second payment adjustment is for physicians who do not achieve meaningful EHR use under the EHR Incentive program. Section 1848(a)(7) of the Act provide s for a downward payment adjustment of 1 percent in 2015 , 2 percent in 2016, and 3 percent in 2017 . We not e that the adjustment in 2015 for not achieving meaningful use is increased by 1 percentage point (to -2 percent) if the physician was subject to the eRx Incentive Program payment adjustment for 2014. As discussed above, we have finalized our pol icy to allow groups of physicians of 100 or1196 more eligible professionals to elect whether to have their value-based payment modifier based on the quality-tiering methodology. For those groups that elect quality-tiering, we proposed that the maximum payment adjustment be -1.0 percent for poor performance (75 FR 45010). We stated that due to the budget neutrality requirement, we did not propose the exact amount of the upward payment adjustments for high performance unde r the quality-tiering approach because the upward payment adjustments (in the aggregate) will have to balan ce the downward payment adjustments in order to achieve budget neutrality. Thus, we proposed to determine the projected aggregate amount of downward payment adjust ments and then calculate the upward payment adjustment factor based on the amount of the pr ojected aggregate upward payment adjustments. For groups of physicians subject to the value- based payment modifier that have not met the PQRS criteria for satisfactory reporting as described above (i ncluding those groups that have not participated in any of the PQRS reporting me chanisms), we proposed to set their value-based payment modifier at -1.0 percen t (77 FR 45010). We arrived at our proposal for a -1.0 percent downward adjustment using the following rationale: Section 1848(p)(1) of th e Act requires us to differentiate payment based on a comparison of qua lity of care furnished compared to cost. Because we do not have performance rates on whic h to assess the quality of care furnished by these groups, we can differentiate payment based on costs only rather than quality and cost as required by statute. Due to the fact that the va lue-based payment modifier is just starting in 2015, we do not wish to apply a greater downw ard payment adjustment for non-satisfactory reporters than we are proposing for the low quality/high cost groups that request that their valuebased payment modifier be calculated using a quality-tiering approach.
Comment : Commenters expressed general support for our proposal to limit the downside risk to -1.0 percent for groups not participating in the PQRS and to ensure that those groups that elected quality-tiering would not be penalized more than those who did not participate in the1197 PQRS. For example, one commenter noted that absent a specified maximum penalty, practices would be unwilling to risk having their paymen ts significantly cut under a voluntary program. Another commenter expressed appreciation for our proposal to limit payment reductions to 1 percent, but also noted that w ith the potential for additional reductions for PQRS, e-Rx, and a 2 percent sequester-related reduction, the proposed 1 percent reduction still poses some risk. Similarly, some commenters requested a higher floor on downward payment adjustments, for example, -0.5 percent rather than -1.0 percent or even no negative adjustment for practices that opt into quality-tiering. One comm enter raised a question as to wh ether participants in qualitytiering should be penalized at all given they had taken the minimum step of reporting PQRS data. As an alternative, this commenter recomme nded that CMS consider upward adjustments for groups that perform well with no adjustment for the remainder. Another commenter offered the view that with the possibility of a downward payment adjustment, only high quality/low cost physicians will participate in the program, which would result in a narrow range of comparisons that could be made and high performers being classi fied as being low. In their view, this would limit the ability to learn from the program. In contrast, however, we received many comme nts suggesting that the proposed payment adjustments were insufficient to motivate change at the physician level. Hence, one commenter recommended that quality-tiered scoring be manda tory for groups that report PQRS measures in 2013 as not doing so effectively crea tes a one-year opt out. Furthe r, they recommended that the maximum downward adjustment be increased to -3.0 percent as it would both motivate change among lower performing physicians while better making available a sufficiently meaningful reward for good performance. Some commenter s recommended that CMS apply higher payment differentials, some as high as +/- 10 percent or more either in 2015 or subsequent years. Related to this, some commenters expresse d concern that since the upward payment1198 adjustment was yet unspecified, there was little in centive or clarity in terms of the advantages and risks for participating in the program. One commenter sought clarity on whether budget neutrality meant that gr oups that elect quality -tiering would be “vying to receive an upward modifier adjustment from a pool of funds deri ved from groups that r eceived the -1.0 percent adjustment or would be competing against one another. Response : While we appreciate comments sugges ting larger payment adjustments to more strongly encourage quality improvements, we are finalizing our proposed adjustments as we believe they better align with our goal to gradually phase in th e value-based payment modifier. We anticipate that as we gain more experience with our value-based payment modifier methodologies, we will consider ways to increase the amount of payment at risk. We also appreciate concerns expressed about the uncertain of the amount of the upward payment adjustment; however, given statutory re quirements for budget neutrality, we have not identified a way to specify an upward amount until all downward adjustments have been determined. We are open to comments on how we might be able to provide an upward payment amount for future rulemaking. We also wish to clarify that the total amount of upward payment adjustments is a fixed amount that is equa l the amount made avai lable through downward payment adjustments. In summary, we are finalizing our proposal to establish a -1.0 value-based payment modifier adjustment for those gr oups of physicians of 100 or more eligible professionals that fall into category 2, which are those th at neither (a) self-nominate for the PQRS as a group and report at least one measure nor (b) elect the PQRS administra tive claims option for CY 2013. We also are finalizing our proposal to limit the downsid e payment adjustment for groups of physicians that elect the quality-tieri ng option at -1.0 percent. h. Value-Based Payment Modifier Scoring Methodology1199 Section 1848(p)(1) of the Act requires the Secretary to esta blish a payment modifier that provides for differential payment to a physician or group of physicians under the fee schedule based upon the quality of care furnished compared to cost during a performance period. As noted previously, the statute requir es that quality of care furnished and cost shall be evaluated, to the extent practicable, based on composites of quality of care furnished and cost. In making our proposals, we developed two models that compare the quality of care furnished to costs: a quality-t iering model and a total performa nce score model. We proposed the quality-tiering model for the value-based pa yment modifier, and solicited comments on the total performance score model (77 FR 44010-12). (1) Quality-Tiering Model The quality-tiering model compares the quality of care composite with the cost composite to determine the value-based payment modifier. To make this comparison, we proposed to classify the quality of care composites scores into high, average, and low quality of care categories based on whether they are statistically above, not different fr om, or below the mean quality composite score. We seek to ensure that thos e groups of physicians classified as high or low performers have performance that is meaningf ully different from average performance (to be sure that no group of physicians is disadvantaged for performan ce only slightly different from the benchmark) and is precisely measured (to ensure that no group of physicians is disadvantaged by an inaccurate performance asse ssment). We proposed to assess meaningful differences as those performance scores that are at least one standard deviation from the mean. We proposed to assess precision by requiring a gr oup of physicians’ score to be statistically different from the mean at the 5.0 percent level of significance (that is, a 95 percent confidence interval). Likewise, we proposed to identify those groups of physicians that have cost composite1200

scores that are statisti cally different from the mean cost composite score of all groups of physicians. We proposed to classi fy these groups of physicians into high, average, and low cost categories based on whether they are significantly above, not differe nt from, or below the mean cost composite score as described above with re ference to quality composite. We proposed to assess meaningful differences as those performa nce scores that are at least one standard deviation from the mean and we proposed to assess precision at th e 5.0 percent level of significance. We proposed to compare quality of care compos ite classification with the cost composite classification to determine the value-based payment modifier adjustment according to the amounts in Table 126.

TABLE 126: Value-Based Payment Modifier Amounts for the Quality-Tiering Approach Quality/cost Low cost Average cost High cost High quality +2.0x* +1.0x* +0.0% Average quality +1.0x* +0.0% -0.5% Low quality +0.0% -0.5% -1.0% * Groups of physicians eligible for an additional +1.0x if reporting measures and average beneficiary risk score in the top 25 percent of all risk scores.
We proposed to establish the upward paym ent adjustment factor (“x”) after the performance period has ended based on th e aggregate amount of downward payment adjustments. We also proposed to aggregate the downward pa yment adjustments in Table 126 with the downward adjustment for groups of physicians subject to the value-based payment modifier that are not satisfact ory PQRS reporters and then to solve for the upward payment adjustment factor (“x”). For example, after determining the aggregate projected amount of the downward payment adjustments, CMS could calculate that the payment adjustment factor (“x”) would be 0.75 percent such that high quality/low cost groups of physicians would receive a 1.5 percent (2 x 0.75) upward payment adjustment during the payment adjustment period.1201 We also proposed that the scoring me thodology provide a greater upward payment adjustment (+1.0x) for groups of physicians that care for high-risk patients (as evidenced by the average HCC risk score of the attributed be neficiary population) and submit data on PQRS quality measures through PQRS via the GPRO us ing the web-interface, claims, registries, or EHRs. We proposed to increase the upward payment adjustment to +3x (rather than +2x) for groups of physicians classified as high quality/lo w cost and to +2x (rather than +1x) for groups of physicians that are either hi gh quality/average cost or average quality/low cost if the group of physicians’ attributed patient populat ion has an average risk score th at is in the top 25 percent of all beneficiary risk scores. In other words, we did not propose this additional upward payment adjustment (+1.0x) for groups of physicians that select the PQRS administrative claims-based reporting option. A second approach to scoring the value-base d payment modifier is a total performance score approach. We sought comment on this appro ach. This approach allows us to develop a unique value-based payment modifier for each group of physicians. This approach results in a range of continuous payment adjustments rather than the thresholds proposed in the quality tier approach. This method would be similar to th e approach we use in the Hospital Value-Based Purchasing program where we use a linear excha nge function to develop a unique payment for each hospital. This approach results in a c ontinuous array of unique value-based payment modifiers such that there are no longer cut-off points between high and low performing groups of physicians.
Comment : We received several comments in support of the quality-tiering model. In some cases, commenters noted their support for quality-tiering as it was readily understandable or could provide an incentive to care for difficu lt-to-treat beneficiarie s. MedPAC indicated support for CMS’ proposal to a pply the value modifier bonus or penalty only when a physician1202 group’s performance is significan tly different from the nationa l mean. Further, MedPAC indicated that it has supported an “outlier” approach for cost measures as a reasonable way to identify physicians or groups with extraordinarily higher or lower costs than average. In some cases, commenters suggested that we apply the quality-tiering model in itially, but consider moving to the total performance score model over time. One commenter noted they had general concerns with quality-tiering, but would take a wait-and-see appr oach as long as it was voluntary rather than mandatory. We also received many comments supporti ng the total performance score methodology. Several commenters expressed their view that this methodology better aligned with the hospital value-based purchasing methodology th an did quality-tiering or that it would be most appropriate for hospital-based physicians. Many of these commenters suggested that the total performance score methodology: (1) offered greater incentives for groups to partic ipate in the program or to improve their performance because they could be rewarded fo r either achievement or improvement; and (2) avoided “cut off problems” where groups are plac ed in high and low performing categories that occur under the qual ity-tiering approach. One commenter offered their view that applying a cutoff such as one standard deviation is crude in that a physician pe rforming at 0.99 standard deviations below the mean would be consid ered average while another performing at 1.01 standard deviations below the mean would be c onsidered low. Another commenter observed that since quality-tiering applies to on ly physician groups above or be low one standard deviation, the methodology effectively removes two-thirds of practi ces from its effects. Another suggested that a focus on outliers does little to improve care as variation in performance within groups is hidden. Commenters also noted that CMS might not have sufficient historical data on all1203 physicians to implement this methodology, and s uggested that it could evolve from qualitytiering over time. Response : We appreciate the comments in suppor t of the quality-tiering model, and are finalizing our proposal to adopt this model. We agree with the comm enters that this approach is a reasonable way to phase in the value-based pa yment modifier, especially as more groups of physicians report quality data and we can fine tune our methodology to identify high and low performers. Although we recognize the beneficial aspects of the total performance score model mentioned by the commenters (for example, in centives for continuous improvement and no cutoff issues), we believe that model may be in appropriate when groups of physicians have the ability to select the quality measures on which they report such that there is not a uniform yardstick by which to assess performance improveme nt. Moreover, at this initial stage of the value-based payment modifier, we believe a more reasonable approach is to focus on outliers rather than trying to adjust the payment of ever y group of physicians, despite the fact that a focus on outliers may mask performance vari ation within a group of physicians.
Comment : Also, assuming adoption of the qua lity-tiering model, some commenters suggested a more stringent criterion than one stan dard deviation from the mean to differential outliers. For example, some comm enters suggested that two or thre e standard deviations be used as a threshold for distinguishing groups. In particular, one commenter noted that a more stringent threshold should be used if and when th e risk for downward adjustments increases. In other cases, commenters suggested altern atives to distinguishi ng groups by statistical comparison. For example, one commenter s uggested that CMS explore a concept of “meaningful clinical difference” that is used in the domain of patient self-reported health status. Response : We thank this commenter for their sugge stions on how to distinguish outliers, that is high and low performers, but are finalizing our proposal to use one standard deviation1204 with a 5 percent level of confid ence. We believe distinguishi ng outliers in this way provides substantial confidence to physicians that we will not misclassify groups as high or low performers when they actually are not. A llowing groups of physicians the option to elect quality-tiering also addresses the issues that we are being too stringent in identifying high and low performers. We will be considering the effect s of this policy over the next several years as we implement this program and may consider changes to these policies through future rulemaking.
Comment : Commenters were generally supportiv e of our proposal to offer additional incentives for groups caring for high-risk benefici aries. Some commenters suggested that the high-risk incentives be expanded to include ad ditional physician groups, for example, to those groups with average or high costs who also have average or above average quality scores. Another commenter recommended th at we apply the high-risk bene ficiary upward adjustment to all practices participating in qua lity-tiering—not just those categor ized as high quality/low-cost, high quality/average cost, or aver age quality/low cost tiers—particul arly, if a penalty is assessed for the lowest performing tier. Another commen t suggested that in a budget neutrality system, however, it was impossible to provide an upward bump-up in the payment adjustment for all groups caring for high-risk beneficiaries, because there would be fewer funds to distribute to high performing groups. Response : We thank commenters for their suppo rt and, for the reasons noted above, are finalizing our proposal to provide an upward payment adjustment for groups electing qualitytiering that are high performers and car e for high-risk beneficiaries. i. Proposed Informal Review and Inquiry Process Section 1848(p)(10) of the Act provides that there shall be no administrative or judicial review under section 1869 of the Ac t, section 1878 of the Act, or otherwise of the following:1205

● The establishment of the value-based payment modifier;

● The evaluation of the quality of care composite, including th e establishment of appropriate measure of the quality of care;

● The evaluation of costs composite, includi ng establishment of appr opriate measures of costs;

● The dates of implementation of the value-based payment modifier;

● The specification of the initial performan ce period and any other performance period;

● The application of the valu e-based payment modifier; and

● The determination of costs. Despite the preclusion of admini strative and judicial review, we believe it is useful for groups of physicians to understand how their payment under the PFS could be changed by the value-based payment modifier. We also believ e that an informal mechanism is needed for groups of physicians to review and to identify any possible errors prior to application of the value-based payment modifier. Therefore, we intend to disseminate Physic ian Feedback reports containing calendar year 2013 data in the fall of 2014 to groups of physicians s ubject to these polic ies; these reports would be the basis of the value- based payment modifier in 2015. We proposed that these reports would contain, among other things, the quality a nd cost measures and measure performance and benchmarks used to score the composites, and qu ality of care and cost composite scores, and the value-based payment modifier amount (77 FR 45012). After the dissemination of the Physician Feedback reports in the fall of 2014, we proposed that physicians would be able to e-mail or call a technical help desk to inquire about their report and the calc ulation of the value-based payment modi fier. We envisioned this process to help educate and inform physicians about th e value-based payment modifier, especially for1206 those groups of physicians that have elected that their value-based payment modifier be calculated using a quality- tiering approach. In anticipation of the reports that we w ould produce in 2014, in the fall of 2013 we plan to produce and disseminate Physician Feedback reports at the TIN le vel to all groups of physicians with 25 or more eligible professi onals based on 2012 data. These reports will include a “first look” at the me thodologies we proposed in this rule for the value-based payment modifier. We view these reports as a way to help educate groups of physicians about how the value-based payment modifier could a ffect their payment under the PFS.
Comment : We received comments in support of making feedback available to participating physician groups and the opportunity to discuss this feedback with CMS. One commenter noted that the dissemination of physician feedback reports should be the first step in a large scale educational campaign on the implemen tation of the value-based modifier. Further, in their view, the success of the program depends on physician practices believing in the data and acting on it to improve their performance. Some commenters recommended that data be shared with all satisfactory PQRS reporte rs. One commenter asked that CMS share or post sample data so that physician groups could model what the value-based modifier might mean for them financially as they decide whether or not to participate. Another commenter requested that patient-specific information should be available to assist practices in verifying the data. In contrast, another commenter offered the view th at while these reports could be relevant to primary care physicians or large multi-specialty practices, they might be less so to single specialty practices such as podiatrists. A number of commenters noted the importance of making feedback reports available in a timely manner, and expressed concer ns about the usefulness of data that are not current. For example, commenters reported that untimely data are not actionable and assessing payments on1207 such data offer little incentive for change. One commenter suggested that data need to be timely or penalties should otherwise be waived. We also received comments expressing s upport for the availab ility of technical assistance, for example, through a technical help desk as well as an appeals or review process. One commenter suggested that CMS establish corre ctive action plans or some means to assist poorer performers before applying a payment ad justment. One commenter disagreed with the “limited distribution of physician feedback report s prior to implementatio n of the value based modifier” and suggested we provide feedback reports to all phys icians in advance of payment adjustments.” In addition, some commenters urged CMS to consider adopting a Corrective Action Plan, or similar program, for outliers/poor performers prio r to applying the value-based payment modifier. Response : We thank commenters for their support . We will provide physician feedback reports during the fall of 2014 for all groups of physicians affected by the value-based payment modifier in 2015 and, as discussed below, we will make a help desk available to address questions related to the reports. We also ar e planning on many enhancements and features suggested by the commenters so that the feedba ck reports provide meaningful and actionable information to physicians to improve the quality of care they furnish to Medicare beneficiaries. (4) Physician Feedback Program Section 1848(n) of the Act requires us to pr ovide confidential repo rts to physicians that measure the resources involved in furnishing care to Medicare FFS beneficiaries. Section 1848(n)(1)(A)(iii) of the Act also authorizes us to include in formation on the quality of care furnished to Medicare FFS beneficiaries. In September 2011, we produced and disseminated confidential feedback re ports to physician groups that part icipated in the PQRS Group Practice Reporting Option (GPRO) in 2010, and in March 2012 we produced and disseminated reports to1208 physicians practicing in the following states: Iowa, Kansas, Missour i, and Nebraska. In the CY 2013 PFS proposed rule, we discu ssed that, in the fall of 2012, we plan to disseminate Physician Feedback reports to physician s in nine states (Calif ornia, Iowa, Illinois, Kansas, Michigan, Minnesota, Missouri, Nebr aska, and Wisconsin) based on 2011 data. These reports will contain the PQRS m easures that physicians in these states submitted via any of the PQRS reporting methods, as well as information on 28 administrative claims measures included in the 2010 reports. We also will produce and disseminate Physician Feedback reports to the groups of physicians that reported measures through the PQRS GPRO web interface in 2011. We adjusted and improved the content and organi zation of the Physician Feedback reports that we plan to produce later this year based on th e comments we received from the Program Year 2010 report recipients. We plan to increase our outreach effort s to encourage physicians to view their reports, to begin to understand the met hodologies we have adopted in this final rule for the value-based payment modifier and that are included in the 2011 re ports, and to provide suggestions on how we can make these reports mo re meaningful and actionable in the future. In the fall of 2013, we plan to produce and disseminate Physician Feedback reports at the TIN level to all groups of physicians with 25 or more eligible profe ssionals. These reports will include a “first look” at the methodologies that we have adopted in this final rule for the value-based payment modifier. In addition, section 1848(n) of the Act requires that we us e the episode-based costs in the Physician Feedback reports beginning in 2013 for the reports based on 2012 data. As discussed above in relation to the value-based payment modifier, we plan to include episodebased cost measures for several ep isode types in future Physician Feedback reports. In addition, we plan to consider adjusting the format a nd organization of the reports, to the extent practicable, to address the best practices outlined in the Am erican Medical Association’s1209 Guidelines for Reporting Physician Data. We be lieve that this dissemination plan satisfies our obligations under the section 1848 (p)(4)(B)(ii)(II) of the Act to provide information to physicians and groups of physicians about the quality of care furnished to Medicare FFS beneficiaries. In the fall of 2014, we plan to dissemin ate Physician Feedback reports based on 2013 data that show the amount of the value-ba sed payment modifier and the basis for its determination. We plan to provi de these reports to all groups of physicians (at the TIN level) with 25 or more eligible profe ssionals even though groups of phys icians with 25 to 99 eligible professionals will not be subject to the va lue-based payment modifier in 2015. We are examining whether we can provide reports to groups of physicians with fewer than 25 eligible professionals and individual level reports as well. These reports will contain, among other things, performance on the quality and cost measur es used to score the composites and the valuebased payment modifier amount. As discussed above , we anticipate providing an opportunity for review and correction as outlined in our value-based payment modifier proposals above. We received many comments on our future plans for the Physician Feedback reports. A summary of the comments and our responses to those comments are provided below.
Comment: We received many suggestions from commenters on ways to improve the content, format, and distribution of the Physician Feedback reports (also termed the “Quality and Resource Use Reports” (QRURs)), with a focus on making the content more actionable for quality improvement. Response: We appreciate all of the suggestio ns on how to improve the Physician Feedback reports. We are working with the American Medical Association, state medical societies, specialty societies, a nd other stakeholders to address th ese issues in future feedback reports.1210

Comment: A commenter stated that it was unc lear whether the physician feedback reports will replace the PQRS re ports that are released when incentive payments are distributed and would support the integra tion of the two reports. Response : We are looking at ways to streamline the reports supporting the PQRS and the physician value-based payment modifier programs in order to create one unified format for quality assessment.
Comment : Commenters appreciated CMS’ plan ned physician outreac h activities to garner physician reaction to the information cont ained in the Physician Feedback reports and elicit physician input on ways to increase their ut ility in future years. Additionally, they suggested that CMS should:

● Work with national and st ate medical specialty societie s to ensure that physicians understand these reports.

● Work with medical specialty societies to improve the Physician Feedback reports.

● Further increase physician awareness of and education for the value-based payment modifier and Physician Feedback Program.

● Provide a mechanism for interpretation of feedback reports and meaningful dialogue between physicians, specialty society staff, and CMS. Response : We appreciate the commenters’ suppor t of our outreach activities and are already undertaking the activities recommended by commenters.
Comment : Several commenters stated that ma ny practices did not receive reports for individual physicians within th eir practice or they received re ports for physicians who are no longer in the practice due to inaccuracies. In ad dition, the commenters stated that some practices had a difficult time obtaining the reports. Th e commenters recommended that CMS should work to ensure that it is not difficult for physicians to obtain these reports – particularly if the1211 information on the report is tied to penalties. Response : We are already aware of the conc erns raised by these commenters. Accordingly, we have adjusted our procedur es for disseminating the 2011 physician feedback reports later in 2012, in order to minimize the di fficulties physicians may have in obtaining their reports and to ensure reports go to their intended recipients.
Comment : A commenter expressed concern about possible unintended consequences that physician feedback reports may have for clinical practice. The commenter stated a belief that aspects of the program will lead physicians to avoid sicker, more complicated patients and expressed concern about the po tential of the program to mo ve physician attention toward program compliance and away from evaluating a nd addressing the concerns of patients during visits. The commenter states that this has th e potential to reduce qual ity of care and patient satisfaction. Response : We do not agree that the Physician Feedback reports will have negative consequences on clinical practi ce. We believe that the Phys ician Feedback reports provide useful information to physicians about the quality of care furnished to Medicare beneficiaries and should be used by physicians to determine th e areas where they need to make improvements in their clinical practice. Moreover, the cost measures in th e Physician Feedback reports are risk adjusted so that we are controlling for preexis ting health conditions a nd other patient factors when making comparisons in the reports.
Comment : A number of commenters were concer ned that the Physician Feedback reports would not be provided in time to inform physic ians about their 2015 util ization, which is the basis for the 2017 payment adjustment period. Response : As we stated above, in the fall of 2013, we plan to produce and disseminate Physician Feedback reports at the TIN level to a ll groups of physicians with 25 or more eligible1212 professionals These reports will provide a “first look” at the methodologies that will be used to develop the value-based payment modifier. We view these repor ts as a way to help educate physicians about how the value-based payment m odifier could affect their payment under the PFS. Even though we are applying the value-base d payment modifier to groups of physicians of 100 or more eligible professionals, we belie ve it is important to provide the Physician Feedback reports to a wider audience in anti cipation of making proposals in future rulemaking on applying the value-based payment modifier to all physicians and groups of physicians starting January 1, 2017.
Comment : Several commenters stated that CMS should make the Physician Feedback reports available to all physicians in 2014. Response : We will take the commenters’ reco mmendation under consideration as we develop the policy for disseminating the 2014 Phys ician Feedback reports. However, we believe it is important to priori tize our efforts on groups of physicia ns that would be subject to the value-based payment modifier in the near future first.
Comment : A number of commenters stated th at CMS should provide a mechanism for physicians to request the list of patients for whic h cost and quality measures are attributed in their Physician Feedback reports. Response : We agree that it would be useful for physicians to have a list of the patients who were attributed in the calculation of thei r cost and quality measures and are working to include this information as part of future Phys ician Feedback reports, re cognizing that we seek to ensure that the data provided is used for qua lity improvement purposes and is consistent with privacy regulations.
Comment : A commenter recommended that future Physician Feedback reports focus on the cost of the care provided by the physician recei ving the report instead of the total cost of all1213 care received by the beneficiary. The commente r indicated that this would be both more informative and more actionable for individual physicians than the cu rrent per capita cost

measures. Response : As we stated earlier, one of the principles governing the implementation of the value-based payment modifier is a “focus on sh ared accountability.” Under this principle, we believe that the value-based payment modifier ca n facilitate shared accountability by assessing performance at the practice group level and by focu sing on the total costs of care, not just the costs of care furnished by an individual physic ian. Physicians reporti ng measures at the group level are encouraged to seek innovative ways to furnish high -quality, patient-centered, and efficient care to the Medicare FFS beneficiaries they treat. L. Medicare Coverage of Hepatitis B Vaccine 1. Modification of high risk groups eligible for Medicare Part B coverage of Hepatitis B vaccine. a. Background and Statutory Authority – Medi care Part B Coverage of Hepatitis B Vaccine Section 1861(s)(10)(B) of the Act authorizes Medicare Pa rt B coverage of hepatitis B vaccine and its administration if fu rnished to an individual who is at high or intermediate risk of contracting hepatitis B. High and intermediate ri sk groups are defined in regulations at §410.63. On December 23, 2011, the United States Cent ers for Disease Cont rol and Prevention (CDC) published a Morbidity and Mortality Week ly Report (MMWR), which included an article entitled “Use of Hepatitis B Vaccination for Adu lts with Diabetes Mellitus: Recommendations of the Advisory Committee on Immunization Practices (ACIP).” The article stated that “In the United States, since 1996, a total of 29 outbreaks of HBV [Hepatitis B virus] infection in one or multiple long-term care (LTC) facilities, includi ng nursing homes and assisted-living facilities, were reported to CDC; of these, 25 involved ad ults with diabetes r eceiving assisted blood1214 glucose monitoring. These outbreaks prompted the Hepatitis Vaccines Work Group of the Advisory Committee on Immunizati on Practices (ACIP) to evaluate the risk for HBV infection among all adults with diagnosed diabetes.” “HBV is highly infectious and environmen tally stable; HBV can be transmitted by medical equipment that is contaminated with bl ood that is not visible to the unaided eye. Percutaneous exposures to HBV occur as a resu lt of assisted monitori ng of blood glucose and other procedures involvi ng instruments or parenteral treatmen ts shared between persons. Lapses in infection control during assi sted blood glucose monitoring that have led to HBV transmission include multipatient use of fi nger stick devices designed for si ngle-patient use and inadequate disinfection and cleaning of blood glucose monito rs between patients. Breaches have been documented in various settings, including LTC faci lities, hospitals, community health centers, ambulatory surgical centers, private offices, homes, and health fairs.” Additionally, in analyses of persons without hepatitis B-rela ted risk behaviors (that is, inject ion-drug use, male sex with a male, and sex with multiple partners), persons aged 23 through 59 years with diabetes had 2.1 times the odds of developing acute hepatitis B as those without diab etes; and the odds for hepatitis B infection were 1.5 times as likel y for persons aged 60 and older. (MMWR, December 23, 2011). Based on the Hepatitis Vaccines Work Gr oup findings, ACIP recommended that:

● Hepatitis B vaccination should be administ ered to unvaccinated adults with diabetes mellitus who are aged 19 through 59 years.

● Hepatitis B vaccination may be administered at the discretion of the treating clinician to unvaccinated adults with diabetes mellitu s who are aged 60 years and older. b. Implementation1215 Based on the ACIP recommendations, we proposed to modify §410.63(a)(1), High Risk Groups, by adding new paragraph “(viii) Persons diagnosed with diabetes mellitus.” Since HBV can be transmitted by medical equipment (that is, finger stick devices and blood glucose monitors) that is contaminated with blood that is not visible to the unaided eye, we believe that persons diagnosed with diabetes mellitus should be added to the high risk group. Since lapses in infection control have been repo rted in both community and facil ity settings, the increased risk of contracting HBV is not limited to the facility setting. We belie ve that expanding coverage of Hepatitis B vaccinations and administration to those diagnosed with diabetes mellitus is supported by the findings and evidence reviewed by the Hepatitis Vaccines Work Group and the ACIP recommendations. Hepatitis B vaccination is a preventive measure that needs to occur before exposure. It is difficult to predict wh ich diabetics will eventua lly be exposed in the circumstances that we discussed above. Therefor e, we proposed to expand coverage for hepatitis B vaccine and its administration to all individua ls diagnosed with diabetes mellitus, not just those individuals with diabetes that are receiving glucose monitoring in facilities, for example, in nursing homes. c. Summary of Public Comments We received 15 public comments that supported the proposed rule to expand coverage of hepatitis B vaccination and its administration to individuals diagnosed with diabetes mellitus. We did not receive any public comments that opp osed our proposed expansion. In addition to their support of our proposal, below is a summar y of additional commen ts received and our
responses. Comment : One commenter suggested that coverage should be limited to individuals with diabetes when the treating physician recommends to the individual that he or she receive a hepatitis B vaccination, rather than having the vaccination be mandatory for all individuals1216 diagnosed with diabetes mellitus. Response : We believe that our proposal prov ides the physician with flexibility to determine whether provision of hepatitis B vaccin ation to a patient is appropriate based on the individual patient’s risk factors. Nothing in the proposed rule or this final rule mandates vaccination for individuals diagnosed with diab etes mellitus. Accordingly, we are not making the suggested changes in this final rule.
Comment : Some commenters requested that we provide covera ge under Medicare Part B for all ACIP-recommended immunizations, the he rpes zoster vaccine, and hepatitis C virus screening, as Medicare prev entive benefits. Response : These comments are outside the scop e of this rulemaking, as our proposed rule specifically addressed Medicare coverage of Hepatitis B vaccine and its administration under a specific statute, §1861(s)(1 0)(B) of the Act. The comme nters’ requested expansions would not be based on this statute. Based on the overwhelming support of the public comments received, we are implementing this rule as proposed. M. Updating Existing Standards for E-prescrib ing under Medicare Part D and Lifting the LTC exemption. 1. Background a. Legislative History Section 101 of the Medicare Prescription Dr ug, Improvement, and Modernization Act of 2003 (MMA) (Pub. L. 108-173) amended title XV III of the Act to establish a voluntary prescription drug benefit program at section 1860D-4(e) of the Ac t. Among other things, these provisions required the adoption of Part D e-prescribing standard s. Prescription Drug Plan (PDP) sponsors and Medicare Advantage (MA) organizations offering Medicare Advantage-1217 Prescription Drug Plans (MA-PD) ar e required to establish electron ic prescription drug programs that comply with the e-prescribing standards that are adopted under this authority. There is no requirement that prescribers or dispensers impl ement e-prescribing. However, prescribers and dispensers who electronically tr ansmit prescription and certain other information for covered drugs prescribed for Medicare Part D eligible beneficiaries, dire ctly or through an intermediary, are required to comply with any applicable standa rds that are in effect. The Medicare Part –D eprescribing Program adopts standards that allow Eligible Professionals (EP) to participate in the eRx Incentive Payment program and Other CMS programs that require the reporting of electronic prescribing transactions.

For a further discussion of the statutory ba sis for this final rule and the statutory requirements at section 1860D-4(e) of the Act, pl ease refer to section I. (Background) of the EPrescribing and the Prescription Drug Program proposed rule, published February 4, 2005 (70 FR 6256). b. Regulatory History (1) Foundation and Final Standards (a) Adopting and updating: CMS utilized several rounds of rulemaking to adopt standards for the Part D eprescribing program. Its first rule, whic h was published on November 7, 2005 (70 FR 67568), adopted three standards that were collectively referred to as the “foundation” standards. One of these standards, the National Council for Prescription Drug Programs (NCPDP) SCRIPT Standard, Implementation Guide, Version 5, Release 0 (Version 5.0), May 12, 2004 (excluding the Prescription Fill Status Notif ication Transaction and its three business cases; Prescription Fill Status Notification Transaction--Filled, Prescrip tion Fill Status Notification Transaction--Not1218 Filled, and Prescription Fill Status Notification Trans action--Partial Fill), hereafter referred to as the NCPDP SCRIPT 5.0, is the subject of severa l of the changes effect uated by this and prior final rules. We issued a s ubsequent rule on April 7, 2008 (73 FR 18918) that adopted additional standards which are referred to as “final” standard s. One of these standards, Version 1.0 of the NCPDP Formulary and Benefit standard, Implemen tation Guide, Version 1, Release 0, hereafter referred to as the NCPDP Formul ary and Benefit 1.0) is also the subject of another of the changes effectuated by this final rule. Please se e the “Initial Standards Versus Final Standards” discussion at 70 FR 67568 in the November 7, 2005 rule for a more detailed discussion about “foundation” and “final” standards. (b) Exemption from the NCPDP SCRIPT st andard in long term care settings (LTC) While prescribers and dispensers who electr onically transmit prescription and certain other information for covered drugs prescribed for Medicare Part D eligible beneficiaries, directly or through an intermediary, are generally required to comply with any applicable Part D e-prescribing standards that are in effect at the time of thei r transmission, the early versions of the NCPDP SCRIPT standard did not support the complexities of the prescribing process for patients in long term care faciliti es where the prescribing proce ss involves not only a prescriber and a pharmacy, but also a facility and its staff. As such, we exempted such entities from use of the NCPDP SCRIPT standard. That exempti on, currently found at §423. 160(a)(3)(iv), provides an exemption for entities transmitting prescriptions or prescription-related information where the prescriber is required by law to issue a prescription for a patie nt to a non-prescribing provider (such as a nursing facility) that in turn forwards the prescription to a dispenser. For a more detailed discussion, see the November 7, 2005 final rule (70 FR 67583). (2) Updating e-Pres cribing Standards Transaction standards are periodically updated to take new knowledge, technology and1219

other considerations into account. As CMS adopted specific versions of the standards when it adopted the foundation and final e-pr escribing standards, there was a need to establish a process by which the standards could be updated or replaced over time to ensure that the standards did not hold back progress in the industry. CMS di scussed these processes in its November 7, 2005 final rule (70 FR 67579). The discussion noted that the rulemaking proce ss will generally be used to retire, replace or adopt a new e-prescribing st andard, but it also provided for a simplified “updating process” when a standard could be updated with a newe r “backward-compatible” ve rsion of the adopted standard. In instances in which the user of th e later version can accommodate users of the earlier version of the adopted standard without m odification, it noted that notice and comment rulemaking could be waived, in which case the us e of either the new or old version of the adopted standard would be considered compliant upon the effective date of the newer version’s incorporation by re ference in the Federal Register . We utilized this streamlined updating process when we published an interim final ru le with comment on June 23, 2006 (71 FR 36020). That rule recognized NCPDP SCRIPT 8.1 as a backward compatible update to the NCPDP SCRIPT 5.0, thereby allowing for us e of either of the two versions in the Part D program. Then, on April 7, 2008, CMS used notice and comment rulemaking (73 FR 18918) to finalize the identification of the NCPDP SCRIPT 8.1 as a backward compatible update of the NCPDP SCRIPT 5.0, and, effective April 1, 2009, retire NCPDP SCRIPT 5.0 and adopt NCPDP SCRIPT 8.1 as the official Part D e-prescribing sta ndard. Finally, on July 1, 2010, CMS utilized the streamlined process to recognize NCPDP SCRIPT 10.6 as a backward compatible update of NCPDP SCRIPT 8.1 in an interim final rule (75 FR 38026). In contrast to the extensive updating that was done to the NCPDP SCRIPT standard in the Part D e-prescribing program, the original NCPDP Formulary and Benefit 1.0 is still in place1220 as the official Part D e-prescribing standard. 2. Proposals for Calendar Year 2013 a. Proposed Finalization of NCPDP SCRIPT 10.6 as a Back ward Compatible Version of NCPDP SCRIPT 8.1, Retiremen t of NCPDP SCRIPT 8.1 and Adoption of NCPDP SCRIPT 10.6 as the official Part D E-Prescribing Standard As described in the CY 2013 Physicia n Fee Schedule proposed rule (77 FR 45022- 45023) we proposed to finalize our recogniti on of NCPDP SCRIPT 10.6 as a backward compatible version of the official Part D e- prescribing standard NC PDP SCRIPT 8.1, effective from the effective date of the final rule through October 31, 2013, but, in response to the comments that were received to the interim final rule with comme nt, we also proposed to retire NCPDP SCRIPT 8.1 effective October 31, 2013, a nd we proposed to adopt NCPDP SCRIPT 10.6 as the official Part D e- prescribing standard effectiv e November 1, 2013. For further discussion on our NCPDP SCRI PT updating proposals pleas e see CY 2013 Physician Fee Schedule proposed rule (77 FR 45022 through 45025). As such, we proposed to revise §423.160(b)(2)(i i) so as to limit its application to transactions on or before October 31, 2013 and add a new §423.160(b)(2)(iii) to require that, as of November 1, 2013, providers and dispense rs would use NCPDP SCRIPT 10.6 for the following electronic transactions that convey pres cription or prescription related information:

• Get message transaction.

• Status response transaction.

• Error response transaction.

• New prescription transaction.

• Prescription change request transaction.

• Prescription change response transaction.1221

• Refill prescription request transaction.

• Refill prescription response transaction.

• Verification transaction.

• Password change transaction.

• Cancel prescription request transaction.

• Cancel prescription response transaction

• Fill status notification. Furthermore, we proposed to amend §423.160(b)(1) by adding a new 423.160(b)(1)(iii) to amend the information about which subsequent requirements in the sec tion are applicable to which timeframes and amend §423.160(b)(1)(ii) to lim it its application to transactions on or before October 31, 2013. The following is a summary of the comments we received regarding the finalization of NCPDP SCRIPT 10.6 as a backward compatible version of NCPDP SCRIPT 8.1, the proposed retirement of NCPDP SCRIPT 8.1, and the proposed adoption of NCPDP SCRIPT 10.6 as the official Part D E-Prescribing standard. We received comments on all three proposals.
Comment : All commenters agreed with our pr oposals to finalize NCPDP SCRIPT 10.6 as a backward compatible version of NCPD P SCRIPT 8.1 and to retire NCPDP SCRIPT 8.1. They also agreed that CMS should move forw ard with the adoption of NCPDP SCRIPT 10.6 as the official Part D e-prescribing standard. Response : We appreciate the favorable feedback that we received on this proposal and are in agreement with the commenters who responded.
Comment : Most commenters agreed on our time line to retire NCPDP SCRIPT Version 8.1 on October 31, 2013 and adopt NCPDP SCRIPT Version 10.6 as the official Part D eprescribing standard on November 1, 2013.1222
Response : We appreciate the feedback we rece ived on the proposed timeline to retire NCPDP SCRIPT 8.1 on October 31, 2013 and fina lize the adoption of NCPDP SCRIPT 10.6 on November 1, 2013 as the official Part D e-prescrib ing standard. We are in agreement with those commenters that responde d to finalize NCPDP SCRIPT 10.6 as proposed.
Comment : One commenter suggested that CM S finalize the adoption of the NCPDP SCRIPT Version 10.6 Part D e-prescribing st andard effective Janua ry 1, 2014, which would coincide with the Office of the National Coordina tor for Health IT (ONC) requirement for use of NCPDP SCRIPT 10.6 for certification of electro nic health record (EHR) technology. The commenter did not, however, note any harm that w ould result if we were to stick with the proposed effective date of November 1, 2013. Response : We appreciate the comment, but we do not believe that there is a compelling reason to change the proposed (November 1, 2013) effective date. As proposed, Part D eprescribers will be free to us e either version 8.1 or versi on 10.6 through October 31, 2013, after which time they will need to use version 10.6 when e-prescribing Part D covered drugs for Part D eligible individuals. As such, ONC’s 2011 Ed ition EHR certification criteria (which permit the certification of EHR technology to versions 8.1 or 10.6 and subsequently enab le an eligible professional (EP)/eligible hospital (EH) to us e either standard through the calendar year (CY)/fiscal year (FY) 2013 meaningful use re porting period) and 2014 Edition EHR certification criteria (which requires EHR technology to be ce rtified to only version 10.6 and subsequently enables EPs/EHs to use EHR technology certified to such standard when th ey start their CY/FY 2014 meaningful use reporting) will never require use of a version of NCPDP SCRIPT that is not also an option under the Part D e-prescribing standards. Fu rthermore, NCPDP SCRIPT 10.6 is backwards compatible with version 8.1, so ve rsion 10.6 EHR users will always be able to communicate with version 8.1 users, and vice versa.1223 In light of the overwhelmingly positive comm ents that we received in response to our proposals to finalize the NCPDP SCRIPT 10.6 as a Backward Co mpatible Version of NCPDP SCRIPT 8.1 as of the effective date of this final rule, and retire NC PDP SCRIPT 8.1 and adopt NCPDP SCRIPT 10.6 as the official Part D e-Pr escribing Standard effective November 1, 2013, we are finalizing our proposals. To effectua te this, we revised §423.160(b)(1)(ii) to limit its applicability to transactions taking place be tween April 1, 2009 and October 31, 2013, added a new §423.160(b)(1)(iii) to cover tr ansactions on or after Nove mber 1, 2013, and added a new §423.160(b)(2)(iii) to cover the communication of a prescripti on or prescription-related information between prescribers and disp ensers on or after November 1, 2013. b. Proposed Recognition of NCPDP Formulary and Benefit Standard 3.0 as a Backward Compatible Version of the NCPDP Formulary a nd Benefit Standard 1.0, Proposed Retirement of NCPDP Formulary and Benefit Standard 1.0 an d Proposed Adoption of NCPDP Formulary and Benefit Standard 3.0 Formulary and Benefits standards provide a uniform means for pharmacy benefit payers (including health plans and PBMs) to communicate a range of form ulary and benefit information to prescribers via point-of-care (POC) systems. These include:

• General formulary data (for example, therapeutic classes and subclasses);

• Formulary status of individual drugs (that is, which drugs are covered);

• Preferred alternatives (incl uding any coverage restrictions , such as quantity limits and need for prior authorization); and

• Copayment (the copayments for one drug option versus another). The NCPDP Formulary and Benefits Standard 1. 0 enables the prescriber to consider this information during the prescribing process, and make the most appropri ate drug choice without extensive back-and-forth administrative activit ies with the pharmacy or the health plan.1224
As discussed above, the November 7, 2005 final rule (70 FR 67579) established the process of updating an official Part D e-prescribing standard w ith the recognition of ‘‘backwardcompatible’’ versions of the offi cial standard in instances in which the user of the later version can accommodate users of the earlier version of the adopted standard without modification. In these instances, notice and comment rulemaking coul d be waived, and use of either the new or old version of the adopted standa rd would be considered complia nt with the adopted standard upon the effective date of the newer vers ion’s incorporation by reference in the Federal Register . This backward compatible version updating process allows for the standards’ updating/maintenance to correct t echnical errors, eliminate techni cal inconsistencies, and add optional functions that provide op tional enhancements to the speci fied e-prescribing transaction standard. Since the adoption of the NCPDP Formul ary and Benefits 1.0 sta ndard in the Part D eprescribing program, NCPDP has updated its Form ulary and Benefits standard. Changes were based upon industry feedback and business needs a nd ranged in complexity from creating whole new fields or lists within the standard to si mply changing a particular field designation from mandatory to optional. Each time a change is ma de to a standard it is given a new version number. The current version of the Formul ary and Benefits standard is Version 3.0. One of the major improvements between Ve rsion 1.0 and 3.0 involved the addition of Text message support for “Coverage and Copay Information,” the addition of the “Text Message Type (A46-1S)” field and the addi tion of “Optional Prior Authorization Lists.” Theses list were added for use in conveying prior authorization requirements. Other improvements included conversion of certa in elements from optional to mandatory. Version 3.0 also provides for “Formulary Status List Headers,” which are fields that allow the sender to specify a default formulary status for non-listed drugs. Subsequent versions also allowed for the omission of “Formulary Status Detail” records when the non-listed formulary1225 policies are used exclusively to convey the status of a drug on a formulary. Changes to a standard may also involve removing fields that ar e not widely used in industry. The removed fields are often replaced by new fields that better serve th e business needs of the industry. For example, the following items have been removed through the various updates that led up to Version 3.0: “Classifi cation List” and references to it (such as Drug Classification Information), “Coverage Information Detail – Me dical Necessity (MN),” “Coverage Information Detail–Resource Link–Summary Level (RS),” and th e Classification ID in the Cross Reference Detail. In place of these deleted fields, the following fields were added or amended to ultimately result in Version 3.0: The “Formulary Status existing value 2” field was changed to “On Formulary/Non-Preferred,” and “The file load also enables payers to speci fy a single coveragerelated text message for each drug” field was changed to “A payer may send multiple quantity limits, step medications, text messages and resource links for the same drug.” We reviewed Version 3.0, and based on our findings, we have determined that NCPDP Formulary and Benefits 3.0 maintains full functio nality of the official adopted Part D eprescribing standard NCPDP Formulary and Be nefits 1.0, and would permit the successful communication of the applicable transaction with entities that continue to use Version 1.0. While we would usually use the “backward compatible” waiver of notice and comment procedures that are described above to recognize Version 3.0 as a backward compatible version of the officially adopted Version 1.0, this would ha ve to be done in an interim final rule with comment. As we cannot combine proposals and elemen ts of a final rule in one rule, we elected this one time to formally propose recognizing a s ubsequent standard as a backward compatible version of an adopted standard through full no tice and comment rulemaking to avoid having to publish two rules contemporaneously. We therefor e proposed to recognize the use of either1226 Version 1.0 or 3.0 as compliant with the adopted Version 1.0 effective 60 days after the publication of a final rule. As noted above, according to the November 7, 2005 final rule (70 FR 67580), entities that voluntarily adopt later vers ions of standards that are recognized as backward compatible versions of the official Part D e-prescribing st andard must still accommodate the earlier official Part D e-prescribing standard without modification. Therefore, as we used full notice and comment in place of the backward compatible methodology in this one instance, we also proposed to require users of 3.0 to support user s who are still using Version 1.0 until such time as Version 1.0 is officially reti red as a Part D e-prescribing st andard and Version 3.0 is adopted as the official Part D e-prescribing standard. To effectuate these proposals, we pr oposed to revise §423.16 0(b)(5) by placing the existing material in a new subsection (b)(5)(i), and creating a second new subsection (b)(5)(ii) to reflect the use of Version 3.0. as a backward co mpatible version of the official Part D eprescribing standard, effective 60 days after the public ation of the final ru le through October 31, 2013. We further proposed revising §423.160(b)(5 ) by adding a new section §423.160(b)(5)(iii) to cover Formulary and Benefit tr ansactions on or after November 1, 2013 We also needed to add an end date of [OFR—Insert da te 60 days after publication in the Federal Register ] to §423.160(b)(5)(i). We solicited comments on our proposals, the timing for these proposals, and when we ought to retire Version 1.0 as the offici al Part D e-prescribing standard, and adopt the NCPDP Formulary and Benefit Version 3.0. as the o fficial Part D e-prescr ibing standard. The following is a summary of the comments we received regarding our proposal to recognize NCPDP Formulary and Benefit Standard 3.0 as a backward compatible version of the NCPDP Formulary and Benefit Standard 1.0, the proposed retirement of NCPDP Formulary and Benefit Standard 1.0 and the proposed adoption of NCPDP Formulary and Benefit Standard 3.0.1227

Comment : Commenters generally supported our proposals for effec tive dates for the use of NCPDP Formulary and Benefit Standard 3.0 as a backward compatible version of the adopted NCPDP Formulary and Benefit 1.0 (60 days after the publication of the final rule), and the retirement of Version 1.0 as an official Part D e-prescribing standard as of November 1, 2013. However, one commenter suggested a Version 1.0 sunset date of July 1, 2014 to coordinate the Part D e-prescribing standards with the date upon which NCPDP will cease to support Version
1.0 . Response : We appreciate the overwhelming support from the commenters who agreed witt us in recognizing Version 3.0 as a backwa rd compatible version of Version 1.0 and the retirement of Version 1.0 and the adoption of Ve rsion 3.0 as the official Part D e-prescribing standard effective November 1, 2013.We also a ppreciate the suggestion to alter the proposed retirement date for Version 1.0 to coincide with the date upon which NCPDP will cease to support that version of the sta ndard. While maintaining Versi on 1.0 as a Part D e-prescribing standard would delay the indus try’s fully benefiting from th e improvements found in Version 3.0, as Version 3.0 is a backward compatible ve rsion of Version 1.0, we would not anticipate significant added burden on the industry if we we re to allow the continued use of Version 1.0 until it is no longer supported by NCPDP. As we aim to ensure that our regulations impose the minimum burden possible on the industry, we ther efore believe that it wo uld be appropriate to not finalize the adoption of Version 3.0 at this time. Although the comm ententer have shown support for our proposal we believe that there is ample time to finalize NCPDP Formulary and Benefits Version 3.0 at a later da te in future rulemaking. We believe that allowing the use of Version 3.0 as a backward compatible verion of Version 1.0 would cr eate some confusion because of the extended timeframe to adopt Ve rsion 3.0 and the retirement of Version 1.0 as proposed by the commenters.1228
As a result of the comments, It is our intention to keep NCPD P Formulary and Benefits Version 1.0 as the official standard for the Medicare Part D eprescribing program and hold off on finalizing Verison 3.0 until future rulemaking. c. Proposed Elimination of the Exemption fo r Non-Prescribing Providers (Long Term Care) In our November 16, 2007 proposed rule (72 FR 64902 - 64906), we discussed the inability of NCPDP SCRIPT versions 5.0 a nd 8.1 to support the workflows and legal responsibilities in the long-term care setting, th at is, entities transmitting prescriptions or prescription-related information where the prescr iber is required by law to issue a prescription for a patient to a non-prescribing provider (such as a nursing facili ty) that in turn forwards the prescription to a dispenser (‘‘three-way pr escribing communications’’ between facility, physician, and pharmacy). As such, such entiti es were provided with an exemption from the requirement to use the NCPDP SCRIPT standa rd in transmitting such prescriptions or prescription-related information. On July 1, 2010 we published an IFC (75 FR 38029) in which we conveyed that we would consider removing the LTC exemption when there was an NCPDP SCRIPT standard that could addr ess the unique needs of long-term care settings. We noted that NCPDP SCRIPT Version 10.6 was available, and that we believed that it addressed the concerns of the LTC industry regarding th eir ability to suc cessfully support thei r workflows when eprescribing. We solicited comments on the imp act and timing of adopting version 10.6 as the official Part D e-prescr ibing standard and the removal of th e long-term care facility exemption from the NCPDP SCIPT standard. For further background discussion on our proposal to lift the LTC exemption please refer to the proposed rule (77 FR 45024-45025). We proposed to eliminate the current ex emption at §423.160(a)(3)( iv) upon adoption of NCPDP SCRIPT 10.6 as the official Part D e-pr escribing standard, which, as described above, was proposed to take place on November 1, 2013.1229 We solicited comments on lifting the Long Term Care exemption, effective November 1, 2013 in conjunction with the effective date of NCPDP SCRIPT 10.6. We also solicited comments regarding the impact of these proposed e ffective dates on industry and other interested stakeholders, and whether an earlier or later effective date should be adopted. The following is summary of the comment s we received regarding the proposal.
Comment : The commenters agreed with our pro posal to lift the current exemption for entities transmitting prescriptions or prescripti on-related information in the LTL setting. The commenters, however, did not agree with our pr oposed timeline for the lifting the current exemption. They suggested that CMS push the e ffective date until November 1, 2014 instead of the proposed November 1, 2013 proposal. They stated that while they are suppo rtive of moving to NCPDP SCRIPT 10.6 and encourage LTC providers to move toward a single st andard, they fully expect that those entities currently using HL7or propriety messaging will need additional time to make the transition. They also recommend an extended transition peri od to ensure that both vendors and providers are ready for the new requirements. Response : Upon review, we believe the commen ters have made valid arguments in regards to moving the effectiv e to November 1, 2014. We realize that many in the LTC community may need extra time to transition th eir IT systems to accommodate and support the current Part D e-prescribing standards. Based on industry comments we will lift the LTC exemption based on November 1, 2014 date as sugge sted by the commenters to give them more time to make the transition to a single standard for e-prescribing. Therefore, we will amend §423.160(a)(3)(iv) to insert November 1, 2014 as th e expiration of the exemption. We would note, however, that if a member of the LTC indus try and their trading pa rtner are ready to use this standard to prescribe elec tronically before the exemption is lifted on November 1, 2014, they1230 are certainly free to use the sta ndard, but they will not be requ ired to do so under the Part D eprescribing program.
Comment : One commenter called on CMS to encourage state Boards of Pharmacy to reexamine the medication management process in the LTPAC settings and develop and allow more effective and efficient mechanisms for e- prescribing in LTPAC. The commenter stated that if the e-prescribing system could be suitably, sufficiently and appropriately modified, such that the various state Boards of Pharmacy were to consider a physicians’ order from a facility as a valid prescription, the conditions would be in place for electronic medication management and e-prescribing to be more widely adopted in LTPAC settings. They also asked CMS to facilitate, encourage and work with regulator s, industry and other stakeholde rs to resolve these issues. Response : We have prescribed legislative authority under the MMA to adopt Part D eprescribing standards. The MMA outlines out th e process through which we can adopt Part D eprescribing standards to facilita te e-prescribing. We do not have the authority to facilitate, encourage, or work with the various state Boards of Pharmacy to change how they define the transaction from the LTC facility to the dispensi ng pharmacy. As a result of these comments, we are eliminating the exemption at §42 3.160(a)(3)(iv) effective November 1, 2014.

IV. Additional Provisions A. Waiver of Deductible for Surgical Servi ces Furnished on the Same Date as a Planned Screening Colorectal Cancer Test and Colorect al Cancer Screening Te st Definition—Technical Correction. Section 4104(c) of the Affordable Care Act amended section 1833(b) of the Act to waive the Part B deductible for colorectal cancer screeni ng tests that become dia gnostic in the course of the procedure or visit. Speci fically, section 1833(b) of the Act waives the deductible for1231 “colorectal screening tests regardless of the code that is billed for the establishment of a diagnosis as a result of the test, or the removal of tissue or other matter or other procedure that is furnished in connection with, as a result of, and in the same clin ical encounter as a screening test.” We note that in the proposed rule, we re ferred in this discussi on to section 1833(b)(1) of the Act; however, the relevant amendment was a new sentence added at the end of section 1833(b). We have corrected the reference in this final rule with comment period. To implement this statutory provision, we proposed in the PFS proposed rule for CY 2011 that “all surgical services furnished on the same date as a pl anned screening colonos copy, planned flexible sigmoidoscopy, or barium enema be considered to be furnished in connection with, as a result of, and in the same clinical encounter as the screen ing test.” After receiving public comment, this proposal was finalized in the CY 2011 final ru le with comment period (75 FR 73431) and the policy was implemented, effective January 1, 201 1. However, we neglected to amend our regulations to reflect this policy. When a screening test becomes a diagnostic serv ice, we instruct the practitioner to bill the procedure that is actually furnished and to append th e PT modifier to the diagnostic procedure code that is reported. By use of th is modifier, the practit ioner signals that the procedure meets the cr iteria for the deductible to be waived. In the CY 2013 PFS proposed rule, we propos ed to amend our re gulations at §410.160, Part B annual deductible, to include colorectal sc reening tests that become diagnostic services in the list of services for which the deductible does not apply. Specificall y, we proposed to add a new §410.160(b)(8) to read, “Beginning January 1, 2011, a surgical service furnished on the same date as a planned colorectal cancer screening test as described in §410.37.” The following is summary of the comments we received regarding the proposal to amend our regulations to the policy we adopted for CY 2011 to implement the statutory amendment that1232

waives the Part B deductible for a colorectal can cer screening test that becomes diagnostic.
Comment : We received two comments on this proposal. One commenter was appreciative and supportive of the proposal. The other commenter stated that we had “violated the intent of the Affordable Care Act” and not implemented this provision consistent with the statute at section 1833(b) of the Act. The comment er stated that by using “surgical service” in the proposed regulation when the st atute referred to “other proce dure,” we were inappropriately applying the deductible to pat hology and anesthesia services when they are furnished in connection with a colorectal scr eening test that becomes a diagnos tic procedure. The commenter also expressed concern with our covering proced ures “on the same date” when the Act covers procedures “in the same c linical encounter.” Response: We thank the commenter who supported our proposal. We note that we did not propose to modify the policy we adopted as final in the CY 2011 PFS final rule with comment period, and which we have been applying in accordance with section 1833(b) of the statute since January 1, 2011. Rather, we pr oposed to codify our current policy in our regulations. Our current policy, as stated in th e CY 2011 PFS final rule with comment period, is to waive the deductible for all surgical servic es furnished on the same date as a planned screening colonoscopy, planned flexible sigm oidoscopy, or barium enema (because these services are considered to be “furnished in connection with, as a resu lt of, and in the same clinical encounter as th e screening test.”) We received and responded to comments similar to the second one noted above in the course of ru lemaking for CY 2011. However, because the commenter questioned the language we used in th e proposed text of the regulation, we discuss the issue in this final rule. After evaluating the comment regarding whether the deductible is appropriately applied to payments for anesthesia and biopsy services , we conclude that it is. We believe that the intent of sect ion 1833(b) of the statute, as amended by section 4104(c) of the1233
Affordable Care Act, is to waive the deductib le for tests that are scheduled and begin as colorectal screening tests, but that become diagnostic in the course of the treatment, so that even though the test is no longer considered and bi lled as a screening te st, the deductible is nonetheless waived as it would have been if the test had remained a screening test. Thus, we believe Congress intended to insu re that we apply the deductibl e for these “screening turned diagnostic” tests consistently with the way it is applied to color ectal screening tests. When a colorectal screening test is fu rnished, the payment for moderate sedation is included in the payment for the procedure, and there would be no associated pathology service. The deductible is waived for these tests under se ction 1833(b) of the Act. As a result, the deductible would be waived for the typical sedation furnished in conne ction with a colorectal screening test (since it is included within the code); a nd there would be no need to waiv e any deductible for a pathology service. The proposed regulati on applies the same policy to co lorectal screening tests that become diagnostic. To the extent that moderate se dation is included in a pr ocedure that is billed with the PT modifier, the beneficiary pays no de ductible. When a beneficiary receives anesthesia other than moderate sedation with a colorectal screening test, a separate charge is incurred to which the deductible applies. The proposed re gulation would specify that same policy for screening tests that become diagnostic. We also believe that the language of the Act is consistent with a pplying the deductible to pathology services. By the use of the term a “color ectal screening test regardless of the code that is billed,” the statute waives th e deductible for procedures that, in and of themselves, begin as colorectal screening tests. As noted above, pathology services woul d not be part of a colorectal screening test. In regard to the commenter’s concern about using “same day,” instead of “same clinical encounter,” this too is the po licy we established through notice and comment rulemaking for CY1234 2011. We believe it would be exceedingly rare fo r a beneficiary to have additional procedures on the same date as a screening colorectal can cer test or a “screening turned diagnostic” colorectal procedure that are not in the same clinical encounter. Therefore, we believe “same day” is the practical equivalent of “same clinical encounter.” To the exte nt there is a difference between these two terms, the language we propos ed would provide broader rather than more limited waiver of the deductible as the commenter asserted. Given the practical equivalence between the language in the statut e and in the proposed regulation, and the fact that our claims processing system can easily distinguish “same day” but not “same clinical encounter,” we will not modify our policy or the proposed regula tion language as the commenter suggests. Based upon the comments we received, and furthe r review of the policy we established to implement the statute, we are finalizing the pr oposed amendment to the regulation as initially proposed. Specifically, we will amend the regu lation at §410.160, Part B annual deductible, to include colorectal screeni ng tests that become diagnostic services in the list of services for which the Part B deductible does not apply and will add a new §410.160(b)(8), which will read, “Beginning January 1, 2011, a surg ical service furnished on th e same date as a planned colorectal cancer screening te st as described in §410.37.” Section 103 of the BIPA amended section 1861(p p)(1)(C) of the Act to permit coverage of screening colonoscopies for indi viduals not at high risk for colo rectal cancer who meet certain requirements. To conform our regulations to section 1861(pp)(1)(C) of the Act, we proposed to modify §410.37(a)(1)(iii) of our regulations to define “Screening colonoscopies” by removing the phrase “In the case of an individual at high risk for colorectal cancer” from this paragraph. We also proposed to delete paragraph (g)(1 ) from this section since Medicare no longer receives claims for dates of service betw een January 1, 1998 and June 30, 2001, making this paragraph obsolete. We also proposed to redesi gnate paragraphs (g)(2) through (g)(4) and make1235 technical changes to newly redesignated paragra ph (g)(1) by replacing the reference to paragraph (g)(4) with a reference to newly redesignated paragraph (g)(3).
Comment : We received no comments addressing the proposed modifications to §410.37. Response: We are finalizing the proposed re gulation as initially proposed for §410.37. Specifically, Section 103 of the BIPA amended section 1861(pp)(1)(C) of the Act to permit coverage of screening colonoscopi es for individuals not at high ri sk for colorectal cancer who meet certain requirements. To conform our regul ations to section 1861(pp)(1)(C) of the Act, we will modify §410.37(a)(1)(iii) to define “Screen ing colonoscopies” by removing the phrase “In the case of an individual at high risk for colorectal can cer” from this paragraph. Finally, we will delete paragraph (g)(1) fr om this section since Medicare no longer receives claims for dates of service betw een January 1, 1998 and June 30, 2001, making this paragraph obsolete, will rede signate paragraphs (g)(2) thr ough (g)(4) and make technical changes to newly redesignated paragraph (g)(1) by replacing the reference to paragraph (g)(4) with a reference to newly redesi gnated paragraph (g)(3). B. Physician Self-Referral Pr ohibition: Annual Update to the List of CPT/HCPCS Codes 1. General Section 1877 of the Act prohibits a physicia n from referring a Medi care beneficiary for certain designated health services (DHS) to an entity with which the physician (or a member of the physician's immediate family) has a financial relationship, unless an exception applies. Section 1877 of the Act also prohibits the DHS entity from submitting claims to Medicare or billing the beneficiary or any other entity for Me dicare DHS that are furnished as a result of a prohibited referral. Section 1877(h)(6) of the Act and §411.351 of our regulations specify that the following services are DHS:1236

● Clinical laboratory services.

● Physical therapy services.

● Occupational therapy services.

● Outpatient speech-language pathology services.

● Radiology services.

● Radiation therapy services and supplies.

● Durable medical equipment and supplies.

● Parenteral and ente ral nutrients, equipment, and supplies.

● Prosthetics, orthotics, and pr osthetic devices and supplies.

● Home health services.

● Outpatient prescription drugs.

● Inpatient and outpati ent hospital services. 2. Annual Update to the Code List a. Background In §411.351, we specify that the entire scope of f our DHS categories is defined in a list of CPT/HCPCS codes (the Code List), which is updated annually to account for changes in the most recent CPT and HCPCS Level II publications . The DHS categories defined and updated in this manner are:

● Clinical laboratory services.

● Physical therapy, occupa tional therapy, and outpatient speech-language pathology services.

● Radiology and certain other imaging services.

● Radiation therapy services and supplies.1237

The Code List also identifies those items a nd services that may qualify for either of the following two exceptions to the phys ician self-referral prohibition:

● Dialysis-related drugs furnished in or by an ESRD facility (§ 411.355(g)).

● Preventive screening tests, immuni zations, or vaccines (§ 411.355(h)). The definition of DHS at § 411.351 excludes serv ices that are reimbursed by Medicare as part of a composite rate (unl ess the services are specifically identified as DHS and are themselves payable through a composite rate, such as home health and inpatient and outpatient hospital services). EPO and other dialysis-related drugs furnis hed by an ESRD facil ity (except drugs for which there are no injectable equivalents or othe r forms of administratio n) are currently being paid under the ESRD PPS (effectiv e January 1, 2011) promulgated in the final rule published on August 12, 2010 in the Federal Register (75 FR 49030). Drugs for which there are no injectable equivalents or other forms of ad ministration will be payable under the ESRD PPS beginning January 1, 2014. The Code List was last updated in Addendum J of the CY 2012 PFS final rule with comment period. b. Response to Comments We received no public comments relating to the Code List that became effective January 1, 2012.1238

c. Revisions Effective for 2013 The updated, comprehensive Code List eff ective January 1, 2013, appears on our website

at http://www.cms.gov/Medicare/Fraud-and-Abuse/ PhysicianSelfReferra l/List_of_Codes.html

. Additions and deletions to the Code List c onform it to the most recent publications of CPT and HCPCS Level II and to changes in Me dicare coverage policy and payment status. Tables 127 and 128 identify the additi ons and deletions, respectively, to the comprehensive Code List that become effec tive January 1, 2013. Tables 127 and 128 also identify the additions and deletions to the list of codes used to iden tify the items and services that may qualify for the exception in § 411.355(g) (reg arding dialysis–related outpatient prescription drugs furnished in or by an ES RD facility) and in § 411.355(h) (regarding pr eventive screening tests, immunizations, and vaccines). In Table 127, we specify additions that re flect new CPT and HCPCS codes that become effective January 1, 2013, or that became ef fective since our last update, including those additions that reflect changes in Medicare covera ge policy or payment status. Table 128 reflects the deletions necessary to conform the Code List to the most recent publications of the CPT and HCPCS, and to changes in Medicare c overage policy and payment status. We will consider comments regarding the codes listed in Tables 127 and 128. Comments will be considered if we receive them by the date specified in the "DATES" section of this final rule with comment period. We will not consider any comment that advocates a substantive change to any of the DHS defined in § 411.351.
TABLE 127: Additions to the Ph ysician Self-Referral List of CPT 1/ HCPCS Codes

CLINICAL LABORATORY SERVICES 86152 Cell enumeration & id 86153 Cell enumeration phys interp PHYSICAL THERAPY, O CCUPATIONAL THERAPY, AND OUTPATIENT SPEECH-LANGUAGE PATHOLOGY SERVICES1239
{No additions} RADIOLOGY AND CERTAIN OTHER IMAGING SERVICES 78012 Thyroid uptake measurement 78013 Thyroid imaging w/blood flow 78014 Thyroid imaging w/blood flow 78071 Parathyrd planar w/wo subtrj 78072 Parathyrd planar w/spect&ct RADIATION THERAPY SERVICES AND SUPPLIES 32701 Thorax stereo rad targetw/tx DRUGS USED BY PATIENTS UNDERGOING DIALYSIS {No additions} PREVENTIVE SCREENING TE STS, IMMUNIZATIONS AND VACCINES G0106 Colon CA screen;barium enema G0120 Colon ca scrn; barium enema G0118 Glaucoma scrn hgh risk direc Q2034 Agriflu vaccine 90672 Flu vaccine 4 valent nasal 1 CPT codes and descriptions only are copyright 2012 AMA. All rights are reserved and applicable FARS/DFARS clauses apply. TABLE 128: Deletions from the Physician Sel f-Referral List of CPT 1/ HCPCS Codes

CLINICAL LABORATORY SERVICES 0030T Antiprothrombin antibody 0279T Ctc test 0280T Ctc test w/i&r PHYSICAL THERAPY, O CCUPATIONAL THERAPY, AND OUTPATIENT SPEECH-LANGUAGE PATHOLOGY SERVICES {No deletions} RADIOLOGY AND CERTAIN OTHER IMAGING SERVICES 78006 Thyroid imaging with uptake 78007 Thyroid image mult uptakes 78010 Thyroid imaging 78011 Thyroid imaging with flow RADIATION THERAPY SERVICES AND SUPPLIES {No deletions}1240

DRUGS USED BY PATIENTS UNDERGOING DIALYSIS {No deletions} PREVENTIVE SCREENING TE STS, IMMUNIZATIONS AND VACCINES {No deletions} 1 CPT codes and descriptions only are copyright 2012 AMA. All rights are reserved and applicable FARS/DFARS clauses apply.

V. Collection of Information Requirements Under the Paperwork Reduction Act of 1995, we are required to provi de 60-day notice in the Federal Register and solicit public comment before a coll ection of information requirement is submitted to the Office of Management and Budget (OMB) for review and approval. In order to fairly evaluate whether an information co llection should be approved by OMB, section 3506(c)(2)(A) of the Paperwork Reduction Act of 1995 requires that we solicit comment on the following issues:

● The need for the information collection and its usefulness in carrying out the proper functions of our agency.

● The accuracy of our estimate of the information collection burden.

● The quality, utility, and clarity of the information to be collected.

● Recommendations to minimize the inform ation collection burden on the affected public, including automate d collection techniques. In the CY 2013 PFS proposed rule, we solicite d public comment on each of the section 3506(c)(2)(A)-required issues for the following in formation collection requirements (ICRs). No PRA-related comments were received. A. ICRs Regarding Durable Medical Equipment Scope and Conditions (§410.38(g))1241 As a condition of payment for certain cove red items of DME, §410.38(g) specifies that a physician must have documented and communicated to the DME supplier that the physician or physician assistant (PA), nurse pr actitioner (NP), or clinical nu rse specialist (CNS) has had a face-to-face encounter with the beneficiary no more than 6 months before the order is written. In the proposed rule, we proposed that when the face-to-face encounter is performed by a physician, the submission of the pert inent portion(s) of the benefici ary’s medical record (portions containing sufficient information to document that the face-to-face encounter meets our requirements) would be considered sufficien t and valid documentation of the face-to-face encounter when submitted to the supplier and made available to CMS or its agents upon request. While we believe that many of the practitioners a ddressed in this final rule with comment period are already conducting a needs a ssessment and evaluating or treating the beneficiary for conditions relevant to the covere d item of DME, this final rule with comment period may require some changes in their procedures to ensure that their documentation fulfills Medicare's regulatory requirements. S uppliers should already be r eceiving written orders and documentation to support the appropriate ness of certain items of DME. To promote the authenticity a nd comprehensiveness of the wr itten order and as part of our efforts to reduce the risk of waste, fraud, and abuse, as a condition of payment, a written order must include the following: (1) the benefi ciaries’ name; (2) the item of DME ordered; (3) the signature of the prescribing practitioner; (4) the prescribing practitioner NPI; and (5) the date of the order. To determine costs, we utilized the Bureau of Labor Statistics mean hourly rates for the professional, analyzed for the year that the orig inal data was received. The hourly rate for a physician, including fringe benefits and overhead is estimated at $118 per hour. The hourly rate, including fringe benefits and ove rhead, for a NP, PA, or CNS is estimated at $55 per hour. The1242 hourly rate for administrative assistant, including fringe benefits and overhead, is estimated at $23 per hour. Physicians are now required to document the face-to-face encounter if it was performed by a PA, NP, or CNS. To allow payment for this documentation, a G code is established for this service. Since the effective date for this regulation is July 1, 2013, only 6 months of year 1 are included in calendar year 2013. Likewise, it was assumed that about 500,000 of these documentation services would be billed in year 1. We estimate the time for a physician to review each one of these encounters that results in an or der is 10 minutes. Therefore, we estimate that the physician documentation burden to review a nd document when a PA, NP or CNS performed the face-to-face encounter in year 1 would be nearly 83,333 hours and a total of 483,333 hours over 5 years. The associated cost in year 1 is nearly $9.8 million and over 5 years has associated costs of nearly $57.03 million based on the growth rate of the Medicare population. The increase is slightly more than five-fold because the numbe r of Medicare beneficiaries would increase over time. The average annual burden over 5- years for 580,000 claims (2,900,000/5) is 96,667 hours at a cost of $11,406,667.
TABLE 129: PHYSICIAN TIME TO DOCUMENT OCCURRENCE OF A FACE-TO-FACE ENCOUNTER Year 1 5 Years Number of claims affected 500,000 2,900,000 Time for physician review of each claim 10 min 10 min Total Time 83,333 hours 483,333 hours Estimated Total Cost (Hours times $118) $ 9,833,333 $57,033,333

We assume it will take 3 minutes for a PA, NP , or CNS to prepare the medical record for the review of the face-to-face encounter. For the 500,000 orders used in the previous estimate, this creates a total of 25,000 hour s at a cost of about $1.4 million in year 1 and nearly 145,000 hours over 5 years at a cost of nearly $8 milli on based on the growth rate of the Medicare population. Though consistent with previous estimates, we believe that using a PA, NP, or CNS1243 hourly rate creates a high burden impact estimat e since most of these tasks would more than likely be completed by administrative personnel. We invited but received no public comments on our estimates related to the appropriateness of these estimates. The average annual burden over 5-years for 580,000 claims (2,900,000/5) is 29,000 hours at a cost of $1,595,000. TABLE 130: Physician Assistant, Nurse Prac titioner or Clinical Nurse Specialist Time
Year 1 5 Years Number of claims affected 500,000 2,900,000 Time for PAs, NPs, or CNSs to gather and provide each claim 3 min 3 min Total Time 25,000 hours 145,000 hours Estimated Total Cost (Hours times $55) $ 1,375,000 $ 7,975,000

This final rule with comment period creates only a minimal change in the normal course of business activities in regard s to recordkeeping. Although we believe the documentation of a needs assessment, evaluation, and/or treatment of a beneficiary for a condition relevant to an item of DME is a common practice, it is possi ble that some practitioners may not be documenting the results of all encounters so there may be additional impact for some practitioners. This regulation requires that the supplier have access to the document ation of the face-toface encounter (required when CMS conducts an audit), CMS already accounts for the audit burden associated with the excha nge of documentation for claims subject to prepayment review (approved under OCN 0938-0969). As a business practice we recognize that some suppliers may receive the documentation of the face-to-f ace for all applicable claims, voluntarily. We believe that the requirements that are set out in this final rule with comment period meet the utility and clarity st andards. We invited but rece ived no public comments on this assumption and on ways to minimize the burden on affected parties. The recordkeeping requirement in §410.38(g)(5) and the requirement to maintain and make the supplier’s order/additional documentation av ailable to CMS upon request is subject to the PRA, but we1244 believe that these requirements are usual and cu stomary business practices as defined in 5 CFR 1320.3(b)(2) and, therefore, the associated burden is exempt from the PRA. B. ICRs Regarding the Physicia n Quality Reporting System (§414.90) We are making several program revisions to the Physician Quality Reporting System for reporting periods that occur in 2013 and 2014, and, th erefore, we are making several revisions to §414.90. All of the requirements and burden es timates are currently approved by OMB under OCN 0938-1059, and are not subject to additiona l OMB review under the authority of the Paperwork Reduction Act of 1995 (44 U.S.C. 3501 et seq. ). First, we are revising §414.90(e) – Use of C onsensus-based Quality Measures. We are redesignating §414.90(e) as §414.90(f) and then re vising newly designate d §414.90(f) to broadly define our use of consensus-based quality meas ures. The current regulation at §414.90(e) (now redesignated as §414.90(f)) states that we will pu blish a final list of measures every year. However, we finalized measures for 2013 and beyond this year. While §414.90(e) (now redesignated as §414.90(f)) contains informati on collection requirements regarding the input process and the endorsement of co nsensus-based quality measures, th is rule would not revise any of the information collection re quirements or burden estimates th at are associated with those provisions. Second, we are revising §414.90(b) – Definitio ns under the Physician Quality Reporting System. Specifically, we are revi sing the definition of “group pr actice” to include groups of 2- 24 eligible professionals in the definition. We are revising the definition of “qualified registry” to indicate CMS’ authority to disqualify registri es. We are also elimin ating the definition of “qualified electronic health r ecord product” to more specif ically address the EHR-based reporting mechanisms available under PQRS as “d irect electronic health record (EHR) product” and “electronic health record (EHR) data submi ssion vendor.” We are also adding the definition1245
of “administrative claims,” wh ich is a newly-established repo rting mechanism available under PQRS for the purpose of reporting quality m easures for the 2015 and 2016 PQRS payment adjustments. In addition, we are adding th e definition of “group practice reporting option (GPRO) web-interface.” While the GPRO web-interface was available as a reporting mechanism in CY 2012, we had not previously included a definition for the GPRO webinterface. While §414.90(b) contains informati on collection requirements regarding the input process and the endorsement of co nsensus-based quality measures, th is rule would not revise any of the information collection requirements or burden estimate s that are associated with §414.90(b). Third, we are revising §414.90(g) (formerly designated as 414.90(f)) – Requirements for the Incentive Payments. In this final rule , we are redesignatin g 414.90(f) as 414.90(g) and making changes to newly designated §414.90(g) to indicate the applicable incentive amounts and requirements for the 2013 and 2014 PQRS incentiv es. While §414.90(e) (newly designated in this final rule as §414.90(f)) cont ains information collection re quirements regarding the input process and the endorsement of co nsensus-based quality measures, th is rule would not revise any of the information collection re quirements or burden estimates th at are associated with those provisions. Fourth, we are adding §414.90(e) – Requirement s for the Payment Adjustments. We are adding §414.90(e) to indicate the applicable adjustment amount s and requirements for the 2015 and 2016 PQRS payment adjustments. While §414.90(e) contains information collection requirements regarding the input process and the endorsement of c onsensus-based quality measures, this rule would not revise any of th e information collection requirements or burden estimates that are associated with those provision s. The impact of this revision to the current information collection requirements or burden estimat es that are associated with those provisions1246

are described here: The preamble of this final rule with comm ent period discusses the background of the PQRS, provides information about the measures a nd reporting mechanisms that will be available to eligible professionals a nd group practices who choose to participate in the 2013 and 2014 PQRS, and provides the criter ia for satisfactory reporting in CYs 2013 and 2014 (for the 2013 and 2014 PQRS incentives and the 2015 and 2016 PQRS payment adjustments). a. Participation in the 2013 and 2014 PQRS According to the 2010 Reporting Experien ce Report, a total of $391,635,495 in PQRS incentives was paid by CMS for the 2010 program year, which encompassed 168,843 individual eligible professionals. In 2010, eligible professionals earned a 2.0 percent incen tive (that is, a bonus payment equal to 2.0 percent of the total allowed part B ch arges for covered professional services under the PFS furnished by the eligib le professional in th e reporting period) for satisfactory reporting under PQRS. For 2013 a nd 2014, eligible professionals can earn a 0.5 percent incentive for sa tisfactory reporting, a reduction of 1.5 percent from 2010. Therefore, based on 2010, we would expect that appr oximately $97 million (approximately 1⁄4 of $391,635,495) in incentive payments would be dist ributed to eligible professionals who satisfactorily report. However, we estimate that, due to the implementation of payment adjustments beginning in 2015, pa rticipation in PQRS would rise to approximately 300,000 eligible professionals and 400,000 eligible professionals in 2013 and 2014 respectively. The average incentive distributed to each eligible professional in 2010 was $2,157. Taking into account the 1.5 percent incentive redu ction from 2.0 percent in 2010 to 0.5 percent in 2013 and 2014, we estimate that the average amount per eligible pr ofessional earning an incentive in 2013 and 2014 would be $539. Therefore, we estimated that we would distribute approximately $162 million ($539 x 300,000 eligible professionals) and $216 million ($539 x1247 400,000 eligible professionals) in incentive pa yments in 2013 and 2014, respectively. We believe these incentive payments will help offset the cost to eligible professionals participating in PQRS for the applicable year. Please not e that, beginning 2015, incentive payments for satisfactory reporting in PQRS will cease and payment adjustments for not satisfactorily reporting will commence. We noted that the total burden associated with participating in PQRS is the time and effort associated with indicating intent to pa rticipate in PQRS, if applicable, and submitting PQRS quality measures data. When establis hing these burden estimates, we assumed the following:

● The requirements for reporting for the PQRS 2013 and 2014 incentives and payment adjustments for 2015 and beyond would be establis hed as proposed in this 2013 Medicare PFS final rule with comment period.

● For an eligible professional using th e claims, registry, or EHR-based reporting mechanisms and group practices using the registry or EHR-based reporting mechanisms, that the eligible professional or group prac tice would report on 3 measures.

● With respect to labor costs, we belie ve that a billing cl erk would handle the administrative duties associated with participa ting, while a computer an alyst would handle duties related to reporting PQRS quality measures. Acco rding to the Bureau of Labor Statistics, the mean hourly wage for a billing clerk is approx imately $16/hour whereas the mean hourly wage for a computer analyst is approximately $40/hour. b. Burden Estimate on Participation in 2013 and 2014 – New Individual E ligible Professionals: Preparation For an eligible professional who wishes to participate in PQRS as an individual using the traditional reporting mechanisms, the eligible professional need not indicate his/her intent to1248 participate. Instead, the eligible professional ma y simply begin reporting qua lity measures data. Therefore, these burden estimates for individual e ligible professionals part icipating in PQRS are based on the reporting mechanism the individual e ligible professional chooses. However, we believe a new eligible professional or group practice would spend 5 hours—which includes 2 hours to review the PQRS measures list, revi ew the various reporting options, and select a reporting option and measures on which to report and 3 hours to review the measure specifications and develop a mechanism for incorpor ating reporting of the selected measures into their office work flows. Therefore, we believe that the initial administ rative costs associated with participating in PQ RS would be approximately $80 ($16/hour x 5 hours). c. Burden Estimate on Participation in 2013 and 2014 via the Claims Reporting Mechanism – Individual Eligible Professionals (1) The Traditional Claims-based Reporting Mechanism In 2010, approximately 200,000 of the roughl y 245,000 eligible pr ofessionals (or 84 percent) of eligible pr ofessionals used the claims-based re porting mechanism. We believe that although the number of eligible professionals or group practices using the claims-based reporting mechanism will increase in 2013 and 2014, we antic ipated that the percentage of eligible professionals or group practices using the claims-based reporting mechanism will decrease slightly as eligible professi onals and group practices transitio n towards using the EHR-based reporting mechanism. Therefore, we estimated that the percentage of PQ RS participants using the claims-based reporting mechanism will decr ease as we anticipate that more eligible professionals would use the regi stry and EHR-based reporting mech anisms. For these reasons, we estimated that approximately 320,000 eligible pr ofessionals would participate in PQRS using the traditional claims-bas ed reporting mechanism by 2014.1249 With respect to an eligible pr ofessional who participated in PQRS via claims, the eligible professional must gather the re quired information, select the appropriate quality data codes (QDCs), and include the appropr iate QDCs on the claims they submitted for payment. PQRS will collect QDCs as additional (optional) lin e items on the existing HIPAA transaction 837-P and/or CMS Form 1500 (OCN 0938-0999). Base d on our experience w ith the Physician Voluntary Reporting Program (PVRP) , we continue to estimate that the time needed to perform all the steps necessary to repor t each measure via claims woul d range from 0.25 minutes to 12 minutes, depending on the complexity of the meas ure. Therefore, the time spent reporting 3 measures would range from 0.75 minutes to 36 minutes. Using an average labor cost of $40/hour, we estimated that the time cost of repor ting for an eligible professional via claims would range from $0.50 (0.75 minutes x $40/ hour) to $24.00 (36 minutes x $40/hour) per reported case. With respect to how many cases an eligible professional would report when using the claims-based reporting mechanism, we establ ished that an eligible professional would need to report on 50 percent of the e ligible professional’s applicable cases. The actual number of cases on which an eligible professional repo rts would vary depending on the number of the eligible professional’s applicable cases. Howeve r, in prior years, when the reporting threshold was 80 percent, we found that the median numbe r of reporting cases for each measure was 9. Since we reduced the reporting thre shold to 50 percent, we estimated that the average number of reporting cases for each measure would be reduced to 6. Based on these estimates, we estimated that the total cost of reporting for an eligib le professional choosing the claims-based reporting mechanism would range from ($0.50/per re ported case x 6 reported cases) $3.00 to ($24.00/reported case x 6 reported cases) $144. (2) The Administrative Claims Reporting Mechanism.1250 We note that, for the 2015 PQRS payment adjustments, we are finalizing an administrative claims reporting option for eligible professionals and gro up practices. The burden associated with reporting using the administrativ e claims reporting option is the time and effort associated with using this option. To submit quality measures data for PQRS using the administrative claims reporting option, an eligible professional or group practice would need to (1) register as an administrative claims reporte r for the applicable payment adjustment and (2) report quality measures data. With respect to registration, we believe it would take approximately 2 hours to register to participate in PQRS as an administrative claims reporter. Therefore, we estimated that th e cost of undergoing the administ rative claims selection process would be ($16/hour x 2 hours) $32. With respect to reporting, we noted that any burden associated with reporting would be negligible, as an eligible professional or group pr actice would not be requir ed to attach reporting G-codes on the claims they submitted. Rather, CMS would bear the burden of calculating the measures rates from claims data submitted by the eligible professional or group practice. We note that there would be no addi tional burden on the eligible pr ofessional or group practice to submit these claims, as the eligible professiona l or group practice would have already submitted these claims for reimbursement purposes. d. Burden Estimate on Participation in the CY s 2013 and 2014 PQRS via the Registry-based or EHR-based Reporting Mechanism In 2010, approximately 40,000 of the roughl y 245,000 eligible professionals (or 16 percent) of eligible pr ofessionals used the registry-based re porting mechanism. We believe the number of eligible professi onals and group practices using the registry based reporting mechanism would remain the same, as we believe the decision for an eligible professional or group practice to purchase a registry would not likely be solely to report PQRS quality measures1251 data to CMS. Rather, we believe that eligible pr ofessionals use registries for functions other than PQRS and therefore would obtain a registry solely for PQRS reporting by CY 2014. In 2010, only 14 of the roughly 245,000 eligible prof essionals (or <1 percent) of eligible professionals used the EHR-based reporting mechan ism. We believe the number of eligible professionals and group practices using the EHR- based reporting mechanism would increase as eligible professionals become more familiar w ith EHR products. In pa rticular, we believe eligible professionals and group practices would transition from using the claims-based to the EHR-based reporting mechanisms. We estimated that approximately 40,000 eligible professionals (4 percent), whether participating as an individual or part of a group practice, would use the EHR-based reporting mechanism in CY 2014. With respect to an eligible professional or group practice wh o participated in PQRS via a qualified registry, direct EHR product, or EHR data submission vendor product, we believe there would be little to no burden associated for an eligible professional to report PQRS quality measures data to CMS, because the selected reporting mechanism would submit the quality measures data for the eligible professional. Wh ile we noted that there may be start-up costs associated with purchasing a qualified registr y, direct EHR product, or EHR data submission vendor, we believe that an eligible professiona l or group practice would not purchase a qualified registry, direct EHR product, or EHR data subm ission vendor product solely for the purpose of reporting PQRS quality measures. Therefore, we have not included the cost of purchasing a qualified registry, direct EHR, or EHR data submission vendor product in our burden estimates. e. Burden Estimate on Participation in the CYs 2013 and 2014 PQRS – Group Practices Unlike eligible professionals who choose to report individually, we noted that we proposed that eligible professiona ls choosing to participate as pa rt of a group practice under the GPRO would need to indicate thei r intent to participate in PQRS as a group practice. The total1252 burden for group practices who submit PQRS qualit y measures data via the GPRO web-interface would be the time and effort associated with su bmitting this data. To submit quality measures data for PQRS, a group practice would need to (1) be selected to particip ate in the PQRS GPRO and (2) report quality measures data. With respect to the administrative duties for being selected to participate in PQRS as a GP RO, we believe it would take a pproximately 6 hours – including 2 hours to decide to participate in PQRS as a GPRO; 2 hours to self-nominate, and 2 hours to undergo the vetting process with CM S officials – for a group practice to be selected to participate in PQRS GPRO for the applicable year. Therefor e, we estimated that the cost of undergoing the GPRO selection process woul d be ($16/hour x 6 hours) $96. With respect to reporting PQRS quality m easures using the GPRO web-interface, the total reporting burden is the time and effort associated with the group practice submitting the quality measures data (that is, completing th e data collection interf ace). Based on burden estimates for the PGP demonstration, which uses the same data submission methods, we estimated the burden associated with a group pr actice completing the data collection interface would be approximately 79 hours. Therefore, we estimated that the report cost for a group practice to submit PQRS quality measures data fo r an applicable year would be ($40/hour x 79 hours) $3,160. f. Maintenance of Cer tification Program Incentive Eligible professionals who wi sh to qualify for an additiona l 0.5 percent Maintenance of Certification Program incentive would need to “m ore frequently” than is required to qualify for or maintain board certification status participate in a qualifie d Maintenance of Certification Program for the year in which the eligible prof essionals seek to quali fy for this additional incentive and successfully complete a qualified Maintenance of Certific ation Program practice assessment for the applicable year. Although we unde rstand that there is a cost associated with1253 participating in a Maintenance of Certification Board, we believe that most of the eligible professionals attempting to ear n this additional incentive woul d already be enrolled in a Maintenance of Certification Board for reasons ot her than earning the additional Maintenance of Certification Program incentive. Therefore, th e burden to earn this additional incentive would depend on what a certification boa rd establishes as “more frequently” and the time needed to complete the practice assessment component. We expect that the amount of time needed to complete a qualified Maintenance of Certificatio n Program practice assessment would be spread out over time since a quality impr ovement component is often required. With respect to the practice assessment component, acco rding to an informal poll conducted by ABMS in 2012, the time an individual spent to complete the practi ce assessment component of the Maintenance of Certification ranged from 8-12 hours. g. Burden Estimate on Vendor Participation in the 2013 and 2014 Aside from the burden of eligible professi onals and group practices participating in PQRS, we believe that registry and EHR ve ndor products incur cost s associated with participating in PQRS. Based on the number of registries that have self-nominated to become a qualified PQRS registry in prior program years, we estimated that approximately 50 addi tional registries would self-nominate to be considered a qualified re gistry for PQRS. With respect to qualified registries, the total burden for qualified registri es who submitted PQRS quality measures data would be the time and effort associated with su bmitting this data. To submit quality measures data for the proposed PQRS program years, a regi stry would need to (1) become qualified for the applicable year and (2) report quali ty measures data on behalf of its eligible professionals. With respect to administrative duties related to the qua lification process, we estimated that it would take a total of 10 hours – including 1 hour to complete the se lf-nomination statement, 2 hours to1254
interview with CMS, 2 hours to calculate numer ators, denominators, and measure results for each measure the registry wished to report usi ng a CMS-provided measure flow, and 5 hours to complete an XML submission – to become qualified to report PQRS quality measures data. Therefore, we estimated that it would cost a registry approximatel y ($16.00/hour x 10 hours) $160 to become qualified to submit PQRS quality measures data on behalf of its eligible professionals. With respect to the reporting of quality measures data, the burden associated with reporting is the time and effort associated with th e registry calculating qu ality measures results from the data submitted to the registry by its eligible professionals, submitting numerator and denominator data on quality measures, and calculating these measure results. We believe, however, that registries already pe rform these functions for its elig ible professionals irrespective of participating in PQRS. Theref ore, we believe there is little to no additional burden associated with reporting PQRS quality measures data. Wh ether there is any addi tional reporting burden would vary with each registr y, depending on the registry’s level of knowledge with submitting quality measures data for PQRS. With respect to EHR products, the total bu rden for direct EHR products and EHR data submission vendors who submit PQRS quality measur es data would be the time and effort associated with submitting this data. To submit quality measures data for PQRS, a direct EHR product or EHR data submission vendor would need to report quality measures data on behalf of its eligible professionals. Please note that si nce we are not continuing to require direct EHR products and EHR data submission vendors to become qualified to submit PQRS quality measures data, there is no burden associated w ith a qualification process for direct EHR products and EHR data submission vendor products. With respect to reporting qual ity measures data, we believe the burden associated with the EHR ve ndor programming its EHR product(s) to extract1255 the clinical data that the eligible professiona l would need to submit to CMS will depend on the vendor’s familiarity with PQRS and the vendor’s system and programming capabilities. Since we believe that an EHR vendor would be subm itting data for reasons other than reporting under PQRS, we believe there would be no additional burden for an EHR vendor to submit quality measures data for PQRS reporting. g. Summary of Burden Estimates on Participation in the 2013 and 2014 PQRS - Eligible Professionals and Vendors

TABLE 131: ESTIMATED COSTS FOR REPORTING PQRS QUALITY MEASURES DATA FOR ELIGIBLE PROFESSIONALS Estimated Hours Estimated Cases Number of Measures Hourly Rate Total Cost Individual Eligible Professional (EP): Preparation 5.0 1 N/A $16 $80 Individual EP: Claims 0.2 6 3 $40 $144 Individual EP: Administrative Claims 2 1 N/A $16 $32 Individual EP: Registry N/A 1 N/A N/A Minimal Individual EP: HER N/ A 1 N/A N/A Minimal Group Practice: Self-Nomination 6.0 1 N/A $16 $96 Group Practice: Reporting 79 1 N/A $40 $3,160

TABLE 132: ESTIMATED COSTS TO VENDORS TO PARTICIPATE IN PQRS Estimated Hours Hourly Rate Total Cost Registry: Self-Nomination 10 $160 $160 EHR: Programming 0 $0 0

We invited but received no public comments on our estimates related to the impact of the collection of information requirements related to PQRS. However, we belie ve that the estimated changes from the requirements and burden es timates currently approved by OMB under OCN 0938-1059 are due to a combination of all revisions being made at §414.90(b), newly designated §414.90(f), and newly created§414.90(e), rather than just one outstanding provision. Therefore, please note that we have combined all impact s of the collection of information requirements1256
related to PQRS in this section, in lieu of separating these impacts as it was proposed. Otherwise, our burden estimates remain unchanged. C. ICRs Regarding Physician Quality Repor ting System – Requirements for the Payment Adjustments (§414.90) While §414.90 contains information collec tion requirements regarding the PQRS payment adjustments, this rule will not revise any of the information co llection requirements or burden estimates that are associated with those provisions, except for th e provisions that would allow the administrative claims reporting option. Otherwise, all of the requirements and burden estimates are currently approved by OMB under OCN 0938-1083 and are not subject to additional OMB review under the authority of the Paperwork Re duction Act of 1995 (44 U.S.C. 3501 et seq. ). Specifically, although we are finalizing the crite ria to report 1 measure or measures group for the 2015 PQRS payment adjustment, we do not expect eligible professional and group practices to stop reportin g when they have met this threshol d. Rather, since the reporting period for the 2013 PQRS incentive and 2015 PQRS payment adjustment coincide, we expect that all eligible professionals and group practices who use the traditiona l PQRS reporting mechanisms – claims, registry, EHR, and GPRO web interface – will attempt to report PQRS quality measures to meet the criteria for the 2013 PQRS Incentive. Therefore, the burden estimates for the 2013 PQRS incentive apply to the 2015 PQRS payment adjustment. With respect to the 2016 PQRS payment adjustment, we did not finalize the criteria to report 1 measure or measures group. Therefore, at this time, eligible professionals and group practices using the traditional PQRS reporting me chanisms – claims, registry, EHR, and GPRO web interface must meet the criteria for the 2014 PQRS incen tive for the 2016 PQRS payment adjustment. Therefore, the burden estimates for the 2014 PQRS incentive apply to the 20161257 PQRS payment adjustment. (2) The Administrative Claims Reporting Mechanism. We note that, for the 2015 PQRS payment adjust ment, we are finalizing an administrative claims reporting option for eligible professiona ls and group practices. The burden associated with reporting using the administrative claims re porting option is the time and effort associated with using this option. To submit quality m easures data for PQRS using the administrative claims reporting option, an eligible professional or group practice w ould need to (1) elect to use the administrative claims-based reporting mechan ism for the applicable payment adjustment and (2) be analyzed under th e administrative claims-based report ing mechanism. With respect to election, we believe it would take approximately 2 hours to register to participate in PQRS as an administrative claims reporter. Therefore, we estimated that the cost of undergoing the administrative claims selection proce ss would be ($16/hour x 2 hours) $32. With respect to reporting, we noted that any burden associated with reporting would be negligible, as an eligible professional or group pr actice would not be requir ed to attach reporting G-codes on the claims they submitted. Rather, CMS would calculate the administrative claims measures rates from claims submitted by group pr actices and eligible professionals. We note that there would be no additional burden on the eligible professional or group practice to submit these claims, as the eligible professional or group practice would have already submitted these claims for reimbursement purposes. D. Summary of Annual Burden Estimates for Codified Requirements The requirements for the eRx Incentive Pr ogram for 2012—2014 were established in the CY 2012 Medicare PFS final rule. Although we ma de proposals related to the eRx Incentive Program in the CY 2013 Medicare PFS, these pr oposals have no additional burden or impact on the public. Therefore, this rule does not revise the requirements or burden estimates approved by1258

OMB under OCN 0938-1059. We invited but recei ved no public comment on our proposed impact analysis and are therefore finalizing th e analysis for the collection of information requirements associated with the Electronic Prescribing (eRx) Incentive Program.
TABLE 133: Summary of Annual Burden Estimates Regulation section(s) OCN Respondents Responses Burden per response (hr) Total burden (hr) §410.38(g) re: Physician 10 min 96,667 §410.38(g) re: PA, NP, or CNS 0938-New 580,000 580,000 3 min 29,000

§414.90 0938-1059 400,000 400,000 (400,000 responses x 3 measures) 0.5 (31.5 minutes – the median) 200,000

E. Additional Information Collection Requirements While this final rule with comment period will impose collection of information requirements that are set out in th e regulatory text (see above), this rule also sets out information collection requirements that are se t out only in the preamble. Following is a discussion of the preamble-specific information collections, all of which have already received OMB approval. 1. Part B Drug Payment The discussion of average sales price (ASP) issues in section III.B.1 of this final rule with comment period rule does not contain any new info rmation collection requirements with respect to payment for Medicare Part B drugs a nd biologicals under th e ASP methodology. Drug manufacturers are required to submit ASP data to us on a quarterly basis. The ASP reporting requirements are set forth in section 1927(b) of the Act. The burden associated with this requirement is the time and effort required by manufacturers of Medi care Part B drugs and biologicals to calculate, record, a nd submit the required data to CMS. All of the requirements and burden estimates are currently a pproved by OMB under OCN 0938-0921, and are not1259 subject to additional OMB review under the au thority of the Paperwork Reduction Act of 1995 (44 U.S.C. 3501 et seq. ). 2. CAHPS Survey for the Physician Quality Reporting System and Physician Compare As explained previously, the burden estim ates related to PQRS are under OCN 0938- 1083. However, we note that, to meet the crit eria for the 2013 and 2014 PQRS incentives, we are requiring that group practices using the GP RO web interface complete a CAHPS survey. This would require the collection of information to obtain the patient experien ce data that will be included in the quality information reported by elig ible professionals. The data collected in the survey will be scored and reported via Physician Compare on the cms.gov website. The information collection – a survey – will be targeted to Fee-for-service Medicare beneficiaries who have received care in the prior 12 months from the physician group practices participating in Physician Quality Reporting. The survey will be administered in English and Spanish, and beneficiaries may have assistan ce to complete the survey or designate a proxy respond on their behalf. Administering the CAHPS survey is different from the estimates provided from reporting measures, as beneficiaries must actively particip ate in the reporting of data by completing these surveys. According to estimates we have perfor med with respect to administering this survey, we anticipate that it will take approximately 39.53 hours to admini ster the CAHPS survey. We estimate that the cost per response will be $7,673. 50. We understand the estimated cost is high. However, as we indicate in Section G in th is final rule, CMS will assume the expense of administering the CAHPS survey. A summary of the burden estimates for administering the CAHPS survey is provided below:

Time Per Response Hour Per Response Annual Hour Burden Cost Per Response Annual Cost Burden Reporting 20.24 minutes 0.337 39,530 $7.6735 $900,1001260

Record Keeping 0 0 0 0 0 Third Party Disclosure 0 0 0 0 0

Total 20.24 minutes 0.337 39,530 $7.6735 $900,100

F. Submission of PRA-Related Comments If you comment on these information collecti on and recordkeeping requirements, please submit your comments to the Office of Inform ation and Regulatory Affairs, Office of Management and Budget, Attention: CMS Desk Officer, [CMS-1590-FC] Fax: (202) 395-6974; or Email: OIRA_submission@omb.eop.gov

. VI. Waiver of Proposed Rulemaking We ordinarily publish a notice of proposed rulemaking in the Federal Register and invite public comment on the proposed rule. The notice of proposed rulemaking includes a reference to the legal authority under which the rule is proposed, and the terms and substance of the proposed rule or a description of the subject s and issues involved. This procedure can be waived, however, if an agency finds good cause that a notice-and-comment procedure is impracticable, unnecessary, or contrary to the public interest and incorporat es a statement of the finding and its reasons in the rule issued. We utilize HCPCS codes for Medicare payment purposes. The HCPCS is a national drug coding system comprised of Level I (CPT) codes and Level II (HCPCS National Codes) that are intended to provide uniformity to coding proced ures, services, and supplies across all types of medical providers and suppliers. Level I (CPT) codes are copyrighted by the AMA and consist of several categories, including Category I codes which are 5-digit numeric codes, and Category III codes which are temporary codes to track em erging technology, services, and procedures.1261 The AMA issues an annual update of the CPT code set each Fall, with January 1 as the effective date for implementing the updated CPT codes. Th e HCPCS, including both Level I and Level II codes, is similarly updated annually on a CY basi s. Annual coding changes are not available to the public until the Fall immediately preceding th e annual January update of the PFS. Because of the timing of the release of these new codes, it is impracticable for us to provide prior notice and solicit comment on these codes and the RVUs assigned to them in a dvance of publication of the final rule that implements the PFS. Yet, it is imperative that these coding changes be accounted for and recognized timely under the P FS for payment because services represented by these codes will be provided to Medicare beneficiaries by physicians during the CY in which they become effective. Moreover, regulat ions implementing HIPAA (42 CFR parts 160 and 162) require that the HCPCS be us ed to report health care servi ces, including services paid under the PFS. We assign interim RVUs to any ne w codes based on a review of the AMA RUC recommendations for valuing these services. We also assign interim RVUs to certain codes for which we did not receive specific AMA RUC re commendations, but that are components of new combined codes. We set interim RVUs for the component codes in order to conform them to the value of the combined code. Finally, we assi gn interim RVUs to certain codes for which we received AMA RUC recommendations for only one component (work or PE) but not both. By reviewing these AMA RUC recommendations for the ne w codes, we are able to assign RVUs to services based on input from the medical commun ity and to establish payment for them, on an interim basis, that corresponds to the relative resources associated with furnishing the services. We are also able to determine, on an interim fi nal basis, whether the codes will be subject other payment policies. If we did not assign RVUs to new codes on an interim basis, the alternative would be to either not pay for these services during the initial CY or have each Medicare contractor establish a payment rate for these new codes. We believe both of these alternatives1262 are contrary to the public interest, particularly since the AMA RUC process allows for an assessment of the valuation of th ese services by the medical comm unity prior to our establishing payment for these codes on an interim basis. Ther efore, we believe it would be contrary to the public interest to delay esta blishment of fee schedule payment amounts for these codes. For the reasons previously outlined in this section, we find good cause to waive the notice of proposed rulemaking for the interim RVUs fo r selected procedure codes identified in Addendum C and to establish RVUs for these codes on an interim final basis. We are providing a 60-day public comment period. Section II.C. of this final rule with comme nt period discusses the identification and review of potentially misvalued codes by the AM A RUC, as well as our review and decisions regarding the AMA RUC recommendations. Si milar to the AMA RUC recommendations for new and revised codes previously discu ssed, due to the timing of the AMA RUC recommendations for the potentially misvalued codes, it was impracticable for CMS to solicit public comment regarding specific proposals for revi sion prior to this final rule with comment period. We believe it is in the public interest to implement the revised RVUs for the codes that were identified as misvalued, and that have b een reviewed and re-evaluated by the AMA RUC, on an interim final basis for CY 2013. The revi sions of RVUs for these codes will establish a more appropriate payment that better correspond s to the relative res ources associated with furnishing these services. A delay in implemen ting revised values for these misvalued codes would not only perpetuate the known misvaluation fo r these services, it would also perpetuate a distortion in the payment for other services under the PFS. Implementing the changes now allows for a more equitable distribution of paym ents across all PFS services. We believe a delay in implementation of these revisions would be cont rary to the public interest, particularly since the AMA RUC process allows for an assessment of the valuation of these services by the1263 medical community prior to the AMA RUC’s recommendation to CMS. For the reasons previously described, we find good cause to waiv e notice and comment procedures with respect to the misvalued codes and to revise RVUs for th ese codes on an interim final basis. We are providing a 60-day public comment period. We ordinarily provide a 60-day de lay in the effective date of the provisions of a rule in accordance with the Administrative Procedure Ac t (APA) (5 U.S.C. 553(d)), which requires a 30-day delayed effective date, and the Congressi onal Review Act (5 U.S.C. 801(a)(3)), which requires a 60-day delayed effective date for major rules. However, we can waive the delay in the effective date if the Secretary finds, for good cau se, that the delay is impracticable, unnecessary, or contrary to the public intere st, and incorporates a statement of the finding and the reasons in the rule issued (5 U.S.C. 553(d)(3); 5 U.S.C. 808(2)). VII. Response to Comments Because of the large number of public comments we normally receive on Federal Register documents, we are not able to acknowledge or respond to them individually. We considered all comments we received by the date and time specified in the “DATES” section of this preamble, and, when we proceeded with a subsequent document, we responded to the comments in the preamble to that document.

VIII. Regulatory Impact Analysis A. Statement of Need This final rule with comment period is n ecessary in order to ma ke payment and policy changes under the Medicare PFS and to make re quired statutory changes under the Middle Class Tax Relief and Job Creation Act of 2012 (MCTRJCA ), the Affordable Care Act, and other statutory changes. This final rule with comment period also is nece ssary to make changes to Part1264 B drug payment policy and other rela ted Part B related policies. B. Overall Impact We have examined the impact of this rule as required by Executive Order 12866 on Regulatory Planning and Review (Septemb er 30, 1993), Executive Order 13563 on Improving Regulation and Regulatory Review (February 2, 2012), the Regulatory Flexibility Act (RFA) (September 19, 1980, Pub. L. 96-354), section 1102(b) of the Social Security Act, section 202 of the Unfunded Mandates Reform Act of 1995 (Mar ch 22, 1995; Pub. L. 104-4), Executive Order 13132 on Federalism (August 4, 1999) and the Congre ssional Review Act (5 U.S.C. 804(2)). Executive Orders 12866 and 13563 direct agencies to assess all costs and benefits of available regulatory alternatives and, if regulation is necessary, to select regulatory approaches that maximize net benefits (including potential economic, environmental, public health and safety effects, distributive imp acts, and equity). A regulatory impact analysis (RIA) must be prepared for major rules with economically si gnificant effects ($100 million or more in any 1 year). We estimate, as discussed below in this section, that the PFS provi sions included in this proposed rule will redistribute more than $100 million in 1 year. Therefore, we estimate that this rulemaking is “economically significant” as m easured by the $100 million threshold, and hence also a major rule under the Congressional Review Act. Accordingly, we have prepared a RIA that, to the best of our ability, presents the costs and benefits of the rulemaking. The RFA requires agencies to analyze options for regulatory relief of small entities. For purposes of the RFA, small entities include small businesses, nonprofit organizations, and small governmental jurisdictions. Most hospitals a nd most other providers and supplie rs are small entities, either by nonprofit status or by having revenu es of $7.0 million to $34.5 milli on in any 1 year (for details see the SBA’s website at www.sba.gov/content/table-sma ll-business-size-standards (refer to the 620000 series)). Individuals and states are not in cluded in the definition of a small entity.1265 The RFA requires that we analyze regulator y options for small businesses and other entities. We prepare a regulatory flexibility analys is unless we certify that a rule would not have a significant economic impact on a substantial nu mber of small entities. The analysis must include a justification concerning the reason actio n is being taken, the kinds and number of small entities that the rule affects, and an explanation of any meani ngful options that achieve the objectives with less significant adverse ec onomic impact on the small entities. For purposes of the RFA, physicians, N PPs, and suppliers including IDTFs are considered small businesses if they generate revenues of $10 million or less based on SBA size standards. Approximately 95 percent of physicians are considered to be sm all entities. There are over 1 million physicians, other practitioners, an d medical suppliers that receive Medicare payment under the PFS. Because we acknowledge that many of the affect ed entities are small en tities, the analysis discussed throughout the preamble of this proposed rule constitute s our regulatory flexibility analysis for the remaining provisions and addresses comments received on these issues. In addition, section 1102(b) of th e Act requires us to prepare a regulatory impact analysis if a rule may have a significant impact on the ope rations of a substantial number of small rural hospitals. This analysis must conform to the pr ovisions of section 604 of the RFA. For purposes of section 1102(b) of the Act, we define a small rural hospital as a hospital that is located outside of a Metropolitan Statistical Area for Medica re payment regulations and has fewer than 100 beds. We are not preparing an analysis fo r section 1102(b) of the Act because we have determined, and the Secretary cer tifies, that this proposed rule would not have a significant impact on the operations of a substant ial number of small rural hospitals. Section 202 of the Unfunded Mandates Reform Act of 1995 also requires that agencies assess anticipated costs and benefits on State, local, or tribal governments or on the private sector1266 before issuing any rule whose mandates require spending in any 1 year of $100 million in 1995 dollars, updated annually for inflation. In 2012, that threshold is approximately $139 million. This final rule with comment period would have no consequential spending effect on state, local, or tribal governments or on the private sector. Executive Order 13132 establishes certain requirem ents that an agency must meet when it promulgates a proposed rule (and subsequent fi nal rule) that imposes substantial direct requirement costs on state and local governme nts, preempts state law, or otherwise has federalism implications. Since this regulati on does not impose any costs on state or local governments, the requirements of Ex ecutive Order 13132 are not applicable. We have prepared the following analysis, whic h together with the information provided in the rest of this preamble, meets all assessm ent requirements. The analysis explains the rationale for and purposes of this final rule with comment period; details the costs and benefits of the rule; analyzes alternatives; and presents th e measures we would use to minimize the burden on small entities. As indicated elsewhere in this final rule with comment period, we proposed to implement a variety of changes to our regulations , payments, or payment policies to ensure that our payment systems reflect changes in medical pr actice and the relative value of services, and to implement statutory provisions. We provided information for each of the policy changes in the relevant sections of this final rule with comment period. We are unaware of any relevant federal rules that duplicate, overlap, or conflict with this final rule wi th comment period. The relevant sections of this final rule with comment period c ontain a description of si gnificant alternatives if applicable. C. Relative Value Unit (RVU) Impacts 1. Resource-Based Work, PE , and Malpractice RVUs Section 1848(c)(2)(B)(ii)(II) of the Act requires that increase s or decreases in RVUs may1267 not cause the amount of expenditures for the year to differ by more than $20 million from what expenditures would have been in the absence of th ese changes. If this threshold is exceeded, we make adjustments to preserve BN. Our estimates of changes in Medicare revenue s for PFS services compare payment rates for CY 2012 with final payment rates for CY 2013 using CY 2011 Medicare utilization as the basis for the comparison. To the extent that th ere are year-to-year ch anges in the volume and mix of services furnished by physicians, the actu al impact on total Medicare revenues would be different from those shown in Tables 134 (CY 2013 PFS Final Rule with Comment Period Estimated Impact on Total Allowed Charges by Specialty ) and 135 (CY 2013 PFS Final Rule with Comment Period Estimated Impact on Tota l Allowed Charges by Specialty by Selected Policy). The payment impacts reflect averages fo r each specialty based on Medicare utilization. The payment impact for an individual physician w ould be different from the average and would depend on the mix of services the physician furn ishes. The average ch ange in total revenues would be less than the impact displayed here because physicians furnish services to both Medicare and non-Medicare patients and specialti es may receive substantial Medicare revenues for services that are not paid under the PFS. For instance, independent laboratories receive approximately 85 percent of their Medicare revenues from clinical laboratory services that are not paid under the PFS. Tables 134 and 135 show the payment impact on PFS services. We note that these impacts do not include the effect of the Janua ry 2013 conversion factor changes under current law. The annual update to the PFS conversion factor is calculated based on a statutory formula that measures actual versus allowed or “target” expenditures, and applie s a sustainable growth rate (SGR) calculation intended to control grow th in aggregate Medi care expenditures for physicians’ services. This update methodology is typically referred to as the “SGR”1268 methodology, although the SGR is only one component of the formula. Medicare PFS payments for services are not withheld if the percentage in crease in actual expenditures exceeds the SGR. Rather, the PFS update, as specified in section 1848(d)(4) of the Act, is adjusted to eventually bring actual expenditures back in line with targets. If act ual expenditures exceed allowed expenditures, the update is reduc ed. If actual expenditures are less than allowed expenditures, the update is increased. By law, we are re quired to apply these updates in accordance with section 1848(d) and (f) of the Act, and any nega tive updates can only be averted by an Act of the Congress. While the Congress has provided tem porary relief from ne gative updates for every year since 2003, a long-term solution is criti cal. We are committed to working with the Congress to permanently reform the SGR metho dology for Medicare PFS updates. We provide our most recent estimate of the SGR and physician update for CY 2013 in section III.N. of this final rule with comment period. The following is an explanation of the in formation represented in Table 134:

● Column A (Specialty) : The Medicare specialty code as reflected in our physician/supplier enro llment files.

● Column B (Allowed Charges) : The aggregate estimated PFS allowed charges for the specialty based on CY 2011 utilization and CY 2012 rates. That is, allowed charges are the PFS amounts for covered services and include coinsura nce and deductibles (which are the financial responsibility of the beneficiary). These amounts have been summed across all services furnished by physicians, practitione rs, and suppliers within a speci alty to arrive at the total allowed charges for the specialty.

● Column C (Impact of Work and Malpractice (MP) RVU Changes) : This column shows the estimated CY 2013 impact on total allowed charges of the changes in the work and malpractice RVUs, including the impact of chan ges due to potentially misvalued codes.1269

● Column D (Impact of PE RVU Changes) : This column shows the estimated CY 2013 impact on total allowed charges of the changes in the PE RVUs.

● Column E (Combined Impact) : This column shows the estimated CY 2013 combined impact on total allowed charges of all the changes in the previous columns.
TABLE 134: CY 2013 PFS Final Rule with Comment Period

Estimated Impact on Total Allowed Charges by Specialty* (A) (B) (C) (D) (E) Specialty Allowed Charges (mil) Impact of Work and MP RVU Changes Impact of PE RVU Changes Combined Impact

TOTAL $ 86,588 0% 0% 0% 01-ALLERGY/ IMMUNOLOGY $ 200 0% 3% 3% 02-ANESTHESIOLOGY ** $ 1,923 0% 1% 1% 03-CARDIAC SURGERY $ 369 0% -1% -1% 04-CARDIOLOGY $ 6,733 -1% -2% -2% 05-COLON AND RECTAL SURGERY $ 153 0% 2% 2% 06-CRITICAL CARE $ 263 0% 1% 1% 07-DERMATOLOGY $ 3,024 0% 0% 0% 08-EMERGENCY MEDICINE $ 2,839 0% 0% 0% 09-ENDOCRINOLOGY $ 437 0% 1% 1% 10-FAMILY PRACTICE $ 5,943 2% 4% 7% 11-GASTROENTEROLOGY $ 1,896 0% 0% 0% 12-GENERAL PRACTICE $ 587 0% 1% 1% 13-GENERAL SURGERY $ 2,283 0% 1% 0% 14-GERIATRICS $ 220 1% 3% 5% 15-HAND SURGERY $ 135 0% 1% 1% 16-HEMATOLOGY/ ONCOLOGY $ 1,909 0% 2% 2% 17-INFECTIOUS DISEASE $ 629 0% 1% 1% 18-INTERNAL MEDICINE $ 11,163 2% 3% 4% 19-INTERVENTIONAL PAIN MGMT $ 539 0% 1% 1% 20-INTERVENTIONAL RADIOLOGY $ 204 0% -2% -3% 21-MULTISPECIALTY CLINIC/OTHER PHY $ 81 0% 0% -1% 22-NEPHROLOGY $ 2,080 0% 0% 0% 23-NEUROLOGY $ 1,604 -2% -5% -7% 24-NEUROSURGERY $ 687 0% 0% 0% 25-NUCLEAR MEDICINE $ 49 0% -2% -3% 27-OBSTETRICS/ GYNECOLOGY $ 704 0% 0% 0% 28-OPHTHALMOLOGY $ 5,645 -3% 0% -3% 29-ORTHOPEDIC SURGERY $ 3,643 0% 0% 0% 30-OTOLARNGOLOGY $ 1,076 0% 2% 2% 31-PATHOLOGY $ 1,210 0% -6% -6%1270

(A) (B) (C) (D) (E) Specialty Allowed Charges (mil) Impact of Work and MP RVU Changes Impact of PE RVU Changes Combined Impact

32-PEDIATRICS $ 65 1% 3% 3% 33-PHYSICAL MEDICINE $ 999 -1% -3% -4% 34-PLASTIC SURGERY $ 356 -1% 1% 1% 35-PSYCHIATRY $ 1,170 -1% 3% 2% 36-PULMONARY DISEASE $ 1,703 0% 1% 1% 37-RADIATION ONCOLOGY $ 1,988 0% -7% -7% 38-RADIOLOGY $ 4,818 0% -3% -3% 39-RHEUMATOLOGY $ 548 0% 0% 0% 40-THORACIC SURGERY $ 343 0% -1% -1% 41-UROLOGY $ 1,918 0% -1% -1% 42-VASCULAR SURGERY $ 888 0% -2% -2% 43-AUDIOLOGIST $ 57 0% -4% -4% 44-CHIROPRACTOR $ 746 0% 1% 1% 45-CLINICAL PSYCHOLOGIST $ 575 1% -3% -2% 46-CLINICAL SOCIAL WORKER $ 406 1% -3% -2% 47-DIAGNOSTIC TESTING FACILITY $ 888 0% -7% -7% 48-INDEPENDENT LABORATORY $ 1,073 0% -14% -14% 49-NURSE ANES / ANES ASST ** $ 1,104 0% 1% 1% 50-NURSE PRACTITIONER $ 1,623 1% 3% 4% 51-OPTOMETRY $ 1,061 -1% 1% 1% 52-ORAL/MAXILLOFACIAL SURGERY $ 45 0% 1% 1% 53-PHYSICAL/OCCUPATIONAL THERAPY $ 2,636 0% 4% 4% 54-PHYSICIAN ASSISTANT $ 1,229 1% 2% 3% 55-PODIATRY $ 1,925 0% 2% 2% 56-PORTABLE X-RAY SUPPLIER $ 106 0% 5% 5% 57-RADIATION THERAPY CENTERS $ 72 0% -9% -9% 98-OTHER $ 19 0% 1% 1% * Table 83 shows only the proposed payment policy impact on PFS services. We note that these impacts do not include the effects of the nega tive January 2013 conversion factor change under current law. ** These figures have been revised to correct errors in the calculations presented in the CY 2013 PFS proposed rule. Table 135 shows the estimated impact of selected policies in this fina l rule with comment period on total allowed charges, by specialty. The following is an explanation of the information represented in Table 135:

● Column A (Specialty) : The Medicare specialty code as reflected in our physician/supplier enro llment files.

● Column B (Allowed Charges) : The aggregate estimated PFS allowed charges for the1271 specialty based on CY 2011 utilization and CY 2012 rates. That is, allowed charges are the PFS amounts for covered services and include coinsura nce and deductibles (which are the financial responsibility of the beneficiary). These amounts have been summed across all services furnished by physicians, practitione rs, and suppliers within a speci alty to arrive at the total allowed charges for the specialty.

● Column (C) (Impact of End of PPIS Transiti on): This column shows the estimated CY 2013 impact on total allowed charge s of the changes in the RVUs due to the final year of the PPIS transition. Column D (Impact of New and Revised Code s, Updated Claims Data, MPPR on the TC of ophthalmology and cardiovascular di agnostic tests, and Other Factors) : This column shows the estimated CY 2013 impact on total allowed char ges of the changes in the RVUs, due to new and revised codes, proposed multiple procedure payment reduction for the TC of cardiovascular and ophthalmology diagnostic tests fu rnished on the same day (section III.B.4. of this final rule with comment period), and other final policies that resulted in minimal redistribution of payments under the PFS, the use of CY 2011 claims data to model payment rates, and other factors.

● Column E (Impact of Updated Equipment Interest Rate Assumption) : This column shows the estimated CY 2013 imp act on total allowed charges of the changes in the RVUs resulting from our update to the equipment inte rest rate assumption as discussed in section III.A.2.f. of this final rule with comment period.

● Column F (Impact of Discharge Tr ansitional Care Management Services): This column shows the estimated CY 2013 combined im pact on total allowed charges of the changes in the RVUs resulting from our policy to recogn ize new CPT codes that pay for post-discharge transitional care management services in the 30 da ys following an inpati ent hospital, outpatient1272 observation or partial hosp italization, skilled nursing facility (S NF), or community mental health center (CMHC) discharge as discussed in section III.H.1. of this final rule with comment period.

● Column G (Impact of Input and Pri ce Changes for Certain Radiation Therapy Procedures): This column shows the estimated CY 2013 combined impact on total allowed charges of the changes in the RVUs resulting from our policy to adjust inputs on certain radiation therapy procedures.

● Column H (Cumulative Impact): This column shows the estimated CY 2013 combined impact on total allowed charges of all changes from the policies in this final rule with comment period in the previous columns.

TABLE 135: CY 2013 PFS Final Rule with Co mment Period Estimated Impact on Total Allowed Charges by Specialty by Selected Policy* (A) (B) (C) (D) (E) (F) (G) (H) Specialty Allowed Charges

(mil)Impact of End ofPPIS TransitionNew and RevisedCodes, MPPR, NewUtilization andOther FactorsUpdated EquipmentInterest RateAssumptionTransitional CareManagementInput Changes forCertain RadiationTherapy ProceduresTotal (CumulativeImpact)

TOTAL $ 86,588 0% 0% 0% 0% 0% 0% 01-ALLERGY/ IMMUNOLOGY $ 200 0% 1% 2% 0% 0% 3% 02-ANESTHESIOLOGY ** $ 1,923 1% -1% 0% 0% 0% 1% 03-CARDIAC SURGERY $ 369 -1% 0% 0% 0% 0% -1% 04-CARDIOLOGY $ 6,733 -2% 0% 0% -1% 0% -2% 05-COLON AND RECTAL SURGERY $ 153 1% 0% 0% 0% 0% 2% 06-CRITICAL CARE $ 263 0% 0% 0% 0% 0% 1% 07-DERMATOLOGY $ 3,024 0% 0% 1% -1% 0% 0% 08-EMERGENCY MEDICINE $ 2,839 0% 0% 0% 0% 0% 0% 09-ENDOCRINOLOGY $ 437 1% 1% 0% -1% 0% 1% 10-FAMILY PRACTICE $ 5,943 1% 1% 0% 4% 0% 7% 11- GASTROENTEROLOGY $ 1,896 0% 0% 0% 0% 0% 0% 12-GENERAL PRACTICE $ 587 1% 0% 0% -1% 0% 1% 13-GENERAL SURGERY $ 2,283 1% 0% 0% 0% 0% 0% 14-GERIATRICS $ 220 1% 1% 0% 2% 0% 5%1273

15-HAND SURGERY $ 135 1% 0% 0% -1% 0% 1% 16-HEMATOLOGY/ ONCOLOGY $ 1,909 -1% 3% 1% -1% 0% 2% 17-INFECTIOUS DISEASE $ 629 1% 1% 0% 0% 0% 1% 18-INTERNAL MEDICINE $ 11,163 1% 1% 0% 3% 0% 4% 19-INTERVENTIONAL PAIN MGMT $ 539 1% 0% 0% -1% 0% 1% 20-INTERVENTIONAL RADIOLOGY $ 204 -2% 0% 0% 0% 0% -3% 21-MULTISPECIALTY CLINIC/OTHER PHY $ 81 0% 0% 0% -1% 0% -1% 22-NEPHROLOGY $ 2,080 0% 0% 0% 0% 0% 0% 23-NEUROLOGY $ 1,604 1% -8% 0% 0% 0% -7% 24-NEUROSURGERY $ 687 0% 0% 0% 0% 0% 0% 25-NUCLEAR MEDICINE $ 49 -2% 0% -1% 0% 0% -3% 27-OBSTETRICS/ GYNECOLOGY $ 704 0% 0% 0% -1% 0% 0% 28-OPHTHALMOLOGY $ 5,645 2% -4% 0% 0% 0% -3% 29-ORTHOPEDIC SURGERY $ 3,643 1% 0% 0% 0% 0% 0% 30-OTOLARNGOLOGY $ 1,076 1% 1% 1% -1% 0% 2% 31-PATHOLOGY $ 1,210 -1% -5% 0% 0% 0% -6% 32-PEDIATRICS $ 65 1% 0% 0% 3% 0% 3% 33-PHYSICAL MEDICINE $ 999 1% -5% 0% -1% 0% -4% 34-PLASTIC SURGERY $ 356 1% 0% 0% 0% 0% 1% 35-PSYCHIATRY $ 1,170 0% 2% 0% -1% 0% 2% 36-PULMONARY DISEASE $ 1,703 0% 1% 0% -1% 0% 1% 37-RADIATION ONCOLOGY $ 1,988 -4% 2% -3% -1% -1% -7% 38-RADIOLOGY $ 4,818 -2% 0% -1% 0% 0% -3% 39-RHEUMATOLOGY $ 548 0% 1% 0% -1% 0% 0% 40-THORACIC SURGERY $ 343 -1% 0% 0% 0% 0% -1% 41-UROLOGY $ 1,918 -2% 1% 0% -1% 0% -1% 42-VASCULAR SURGERY $ 888 -1% -1% 0% 0% 0% -2% 43-AUDIOLOGIST $ 57 -3% 0% 0% 0% 0% -4% 44-CHIROPRACTOR $ 746 1% 0% 0% 0% 0% 1% 45-CLINICAL PSYCHOLOGIST $ 575 -2% 1% 0% 0% 0% -2% 46-CLINICAL SOCIAL WORKER $ 406 -2% 0% 0% 0% 0% -2% 47-DIAGNOSTIC TESTING FACILITY $ 888 -5% 0% -2% -1% 0% -7%1274

48-INDEPENDENT LABORATORY $ 1,073 -2% -12% 1% -1% 0% -14% 49-NURSE ANES / ANES ASST ** $ 1,104 2% -1% 0% 0% 0% 1% 50-NURSE PRACTITIONER $ 1,623 1% 1% 0% 2% 0% 4% 51-OPTOMETRY $ 1,061 2% -1% 0% 0% 0% 1% 52- ORAL/MAXILLOFACIAL SURGERY $ 45 1% 0% 1% -1% 0% 1%
53- PHYSICAL/OCCUPATION AL THERAPY $ 2,636 2% 2% 0% 0% 0% 4%

54-PHYSICIAN ASSISTANT $ 1,229 1% 0% 0% 2% 0% 3% 55-PODIATRY $ 1,925 2% 0% 1% -1% 0% 2% 56-POR X-RAY SUPPLIER $ 106 1% 4% 1% -1% 0% 5% 57-RADIATION THERAPY CENTERS $ 72 -5% 4% -5% -1% -1% -9% 98-OTHER $ 19 1% 0% 0% 0% 0% 1% * Table 135 shows only the proposed payment policy impact on PFS services. We note that these impacts do not include the effects of the nega tive January 2013 conversion factor change under current law. ** These figures have been revised to correct errors in the calculations presented in the CY 2013 PFS proposed rule.
2. CY 2013 PFS Impact Discussion a. Changes in RVUs The most widespread specialty impacts of the RVU changes are generally related to several factors. First, as disc ussed in section III.A.2. of this final rule with comment period, we are currently implementing the final year of th e 4-year transition to new PE RVUs using the PPIS data that were adopted in the CY 2010 PFS final rule with comment period. This impact appears in column C of Table 135. The impacts of the final year of the transition are generally consistent with the impacts that would be e xpected based on the impacts displayed in the CY 2012 final rule with comment period. The se cond factor is the post-discharge transitional care management policy, under which we will pay for care coordination in the 30 days following an inpatient hospital, outpatient hospital observation services or pa rtial hospitalization, SNF, or1275 CMHC discharge from the treating physician in the hospital to the beneficiary’s primary physician in the community. We estimate that CPT codes 99495 and 99496 for TCM will redistribute approximately $0.6 bill ion in allowed charges to pr imary care specialties under the physician fee schedule (estimated using the CY 2012 CF), with approximately 20 percent of that representing redistributed benefi ciary coinsurance. The redistri butive effect of this policy appears on column F of Table 135. Column E in Table 135 also reflects updates to the proposed interest rate assumption used in the medical equipment calculation in the PE RVU methodology. Other final rule policies, including the multiple procedure payment reduc tion policy for the technical component of diagnostic cardiovascular and opht halmological procedures, as well as new values for new and revised codes are included in Column D. Column G in Table 135 isolates th e impact of revisions to equipment inputs and prices fo r certain radiation therapy serv ices. Table 135 shows the same information as provided in Table 134, but rather than isolating the policy impact on physician work, PE, and malpractice separa tely, Table 135 shows the impact of varied final policies on total RVUs. b. Combined Impact Column E of Table 134 and column H of Table 135 display the estimated CY 2013 combined impact on total allowed charges by sp ecialty of all the RVU and MPPR changes. These impacts range from an increase of 7 percent for family practice to a decrease of 14 percent for independent laborator y. We have received numerous new codes with new values and revised codes with new values for CY 2013 as a result of our ongoing misvalued codes initiative. Many of the new and revised codes that we valued on an interim basis for CY 2013 originated with the potentially misvalued codes initiative. Reduc tions for pathology, neurology, and independent laboratories are a result of the pot entially misvalued code initiativ e. In the case of independent1276 laboratories, we note that indepe ndent laboratories receive the majority of the Medicare revenue from the Clinical Lab Fee Schedule, which is unaffected by the potenti ally misvalued code initiative. Again, these impacts are estimated prio r to the application of the negative CY 2013 Conversion Factor (CF) update appli cable under the current statute. Table136 (Impact of Final Rule with Comm ent Period on CY 2013 Payment for Selected Procedures) shows the estimated impact on total payments for selected high volume procedures of all of the changes discussed previously. We have included CY 2013 payment rates with and without the effect of the CY 2013 negative PFS CF update for comparison purposes. We selected these procedures because they are th e most commonly furnished by a broad spectrum of physician specialties. There are separate columns th at show the change in the facility rates and the nonfacility rates. For an explanation of f acility and nonfacility PE, we refer readers to Addendum A of this final ru le with comment period.1277TABLE 136: Impact ofFinal Rule with Comment Period on CY2013 Payment for Selected Procedures*Facility Nonfacility

CPT/ HCPCS 1 MODShort Descriptor CY 2012 2

CY 2013 3 (pre update) % Change (pre update) CY 2013 4 (post update) % Change (post update) CY 2012 2 CY 2013 3 (pre update) % Change (pre update) CY 2013 4 (post update) % Change (post update)11721 Debride nail 6 or more $25.19 $24.48-3% $18.00 -29% $43.57 $44.89 3% $33.00 -24%17000 Destruct premalg lesion $56.16 $57.132% $42.00 -25% $81.01 $83.32 3% $61.25 -24%27130 Total hip arthroplasty $1,445.58$1,452.08 0% $1,067.53 -26% NA NA NA NA NA27244 Treat thigh fracture $1,231.48$1,240.22 1% $911.78 -26% NA NA NA NA NA27447 Total knee arthroplasty $1,544.29$1,550.36 0% $1,139.79 -26% NA NA NA NA NA33533 Cabg arterial single $1,950.35 $1,904.37 -2% $1,400.04 -28% NA NA NA NA NA35301 Rechanneling of artery $1,112.35 $1,095.35 -2% $805.28 -28% NA NA NA NA NA43239 Upper gi endoscopy biopsy $174.61 $174.450% $128.25 -27% $351.61 $359.45 2% $264.26 -25%66821 After cataract laser surgery $307.70 $324.76 6% $238.76 -22% $326.08 $344.15 6% $253.01 -22%66984 Cataract surg w/iol 1 stage $760.74 $666.53 -12% $490.02 -36% NA NA NA NA NA67210 Treatment of retinal lesion $504.10 $519.28 3% $381.76 -24% $523.84 $537.64 3% $395.26 -25%71010 Chest x-ray 1 view frontal NA NA NA NA NA $23.83 $23.80 0% $17.50 -27%71010 26 Chest x-ray 1 view frontal $8.85 $8.840% $6.50 -27% $8.85 $8.84 0% $6.50 -27%77056 Mammogram both breasts NANA NA NA NA $112.32 $115.28 3% $84.75 -25%77056 26 Mammogram both breasts $42.55 $42.17 -1% $31.00 -27% $42.55 $42.17 -1% $31.00 -27%77057 Mammogram screening NA NA NA NA NA $81.35 $82.30 1% $60.50 -26%77057 26 Mammogram screening $34.38 $34.01 -1%$25.00 -27% $34.38 $34.01 -1% $25.00 -27%77427 Radiation tx management x5 $177.00 $178.19 1% $131.00 -26% $177.00 $178.19 1% $131.00 -26%88305 26 Tissue exam by pathologist $36.08 $36.732% $27.00 -25% $36.08 $36.73 2% $27.00 -25%90935 Hemodialysis one evaluation $72.84 $71.07 -2% $52.25 -28% NA NA NA NA NA92012 Eye exam establish patient $51.40 $53.05 3% $39.00 -24% $82.71 $87.40 6% $64.25 -22%92014 Eye exam&tx estab pt 1/>vst $78.29 $80.26 3% $59.00 -25% $119.81 $126.16 5% $92.75 -23%93000 Electrocardiogram completeNA NA NA NA NA $19.06 $18.36 -4% $13.50 -29%93010 Electrocardiogram report $8.51 $8.16-4% $6.00 -29% $8.51 $8.16 -4% $6.00 -29%127893307 26 Tte w/o doppler complete $45.95 $44.21-4% 32.5 -29% $45.95 $44.21 -4% $32.50 -29%93458 26 L hrt artery/ventricle angio $315.87 $315.24 0% $231.76 -27% $315.87 $315.24 0% $231.76 -27%98941 Chiropract manj 3-4 regions $30.63 $30.27 -1% $22.25 -27% $36.08 $36.39 1% $26.75 -26%99203 Office/outpatient visit new $74.88 $74.81 0% $55.00 -27% $105.18 $107.80 2% $79.25 -25%99213 Office/outpatient visit est $49.69 $49.65 0% $36.50 -27% $70.46 $72.43 3% $53.25 -24%99214 Office/outpatient visit est $76.24 $76.51 0% $56.25 -26% $104.16 $106.44 2% $78.25 -25%99222 Initial hospital care $133.09$134.33 1% $98.75 -26% NA NA NA NA NA99223 Initial hospital care $195.38$197.58 1% $145.25 -26% NA NA NA NA NA99231 Subsequent hospital care $38.12 $38.09 0% $28.00 -27% NA NA NA NA NA99232 Subsequent hospital care $69.78 $70.05 0% $51.50 -26% NA NA NA NA NA99233 Subsequent hospital care $100.07 $101.00 1% $74.25 -26% NA NA NA NA NA99236 Observ/hosp same date $212.05 $212.20 0% $156.00 -26% NA NA NA NA NA99239 Hospital discharge day $103.13$104.40 1% $76.75 -26% NA NA NA NA NA99283 Emergency dept visit $60.25$59.85 -1% $44.00 -27% NA NA NA NA NA99284 Emergency dept visit $114.71$114.26 0% $84.00 -27% NA NA NA NA NA99291 Critical care first hour $217.16 $217.64 0%$160.01 -26% $267.20 $271.71 2% $199.76 -25%99292 Critical care addl 30 min $108.92 $109.50 1%$80.50 -26% $119.47 $120.72 1% $88.75 -26%99348 Home visit est patient NA NA NA NA NA $ 82.03 $ 82.30 0% $60.50 -26%99350 Home visit est patient NA NA NA NA NA $ 171.21 $ 173.43 1% $127.50 -26%G0008 Immunization admin NA NA NA NA NA $24.17 $ 25.85 7% $19.00 -21%1 CPT codes and descriptions are copyright 2012American Medical Association. All Rights Reserved. Applicable FARS/DFARS apply.2 Payments based on the 2012 conversion factor of 34.03763 Payments based on the 2012 conversion factor of 34.0376, adjusted to 34.0066to include the budget neutrality adjustment.4 Payments based on the 2013 conversion factor of 25.0008, which includes the budget neutrality adjustment.1279 D. Effect of Proposed Changes to Medi care Telehealth Se rvices Under the PFS As discussed in section III.E.3 of this fina l rule with comment period, we are finalizing our proposal to add several new codes to the lis t of Medicare telehealth services. While we expect these changes to increase access to care in rural areas, based on recent utilization of similar services already on the telehealth list, we estimate no significant impact on PFS expenditures from the additions. E. Effect of Proposed Definition of Certified Registered Nurse Anesthetists’ (CRNA) Services As discussed in section III.K.1. of this final rule with comment period, we clarified that “anesthesia and related care”, with respect to the statutory benefit category for CRNAs under Section 1861(bb)(2) of the Social Security Act, means those servic es that a certified registered nurse anesthetist is legally authorized to perform in the state in which the service is furnished. .Our final rule clarification recognizes local variation in st ate scope of practice, which does not diverge significantly from current pr actice. Therefore, we estimate no significant budgetary impact from this proposed change. F. Effects of Proposed Change to Ordering Requir ements for Portable X-Ray Services Under the
PFS As discussed in section III.K.2. of this fina l rule with comment pe riod, we are finalizing our proposal to revise our current regulation that limits ordering of portable x-ray services to only a doctor of medicine or a doctor of oste opathy to allow other physicians and nonphysician practitioners (acting within the sc ope of state law and their Medicar e benefit) to order portable xray services. We estimated no significant imp act on PFS expenditures from the additions. G. Geographic Practice Cost Indices (GPCIs) As discussed in section III.E. of this final rule with comment period, we are required to1280

review and revise the GPCIs at least every 3 years and phase in the adjustment over 2 years (if there has not been an adjustment in the past year). For CY 2013, we did not propose any revisions related to the data or methodologies used to calculate the GPCIs. However, since the 1.0 work GPCI floor provided in section 1848 (e)(1 )(E) of the Act is set to expire prior to the implementation of the CY 2013 PFS, the CY 2013 physician work GPCIs and summarized geographic adjustment factors (GAFs) published in addendums D and E of this CY 2013 PFS final rule with comment period do not reflect th e 1.0 work GPCI floor for CY 2013. As required by section 1848 (e)(1)(G) and sec tion1848 (e)(1)(I) of the Act, the 1.5 work GPCI floor for Alaska and the 1.0 PE GPCI floor for fron tier states are applicable in CY 2013. H. Other Provisions of the Final Regulation1. Ambulance Fee ScheduleAs discussed in section III.A. of this fina l rule with comment period, section 306 of the TPTCCA and section 3007 of th e MCTRJCA required the extensi on of certain add-on payments for ground ambulance services, and the extension of certain rural area designations for purposes of air ambulance payment, through CY 2012. As furt her discussed in section III.A. of this final rule with comment period, this legislation is self-implementing, and we proposed to amend the regulation text at §414.610 only to conform the regulations to these self-implementing statutory requirements. As a result, we did not make any policy proposals associated with these legislative provisions and there is no a ssociated regulatory impact. 2. Part B Drug Payment: ASP Issues As discussed in section III of this final rule with comment period, we proposed to update the AMP-based price substitution policy that would allow Medicare to pay based off lower market prices for those drugs and biologicals th at consistently exceed the applicable threshold1281 percentage. Our impact analysis is unchanged from last year (76 FR 73462): based on estimates published in various OIG reports cited in the CY 2012 PFS final rule with comment period (76 FR 73290-1), we believe that this proposal will generate minor savings for the Medicare program and its beneficiaries since any substituted prices would be for amounts less than the calculated 106 percent of the ASP. Our policy clarification regarding Pharmacy Billing for Part B Drugs Administered Incident to a Physician’s Services, which is di scussed in section III of this final rule with comment period states that only physicians and not pharmacies (or DME suppliers) are allowed to bill Medicare under Part B for drugs administered to beneficiaries in physicians’ offices. We do not believe that this clarifi cation will significantly impact the quantity or payment amount for Part B drugs that are administered through implan ted DME and or the procedures used to refill such pumps because it is a clarification of current policy. 3. Medicare Program; Durable Medical Equipm ent (DME) Face-to-Face Encounters and Written Orders Prior to Delivery a. Overall Impact The majority of changes regarding the imp act between the proposed and the final result from the change in timeframe, from 90 days befo re the written order or 30 days after to six months before the written order. Moreover, the effective date fo r this regulation is July 1, 2013; therefore, only 6 months of year 1 (calendar y ear 2013) are included in th is analysis. . We estimated the overall economic impact of this provis ion on the health care sect or to be a cost of $30.2 million in the first year approximately half of which would be in CY 2013. The 5 year impact is $172.3 million. This overall impact is composed of additional administrative paperwork costs to private sector providers; a slight increase in Medicare spending, consisting of1282 additional costs and some offsetting savings; a nd additional opportunity and out-of-pocket costs to Medicare beneficiaries. We believe there are li kely to be other benefits and cost savings that result from the DME face-to-face requirement; however, many of those benefits cannot be quantified. For instance, we expect to see savi ngs in the form of reduced fraud, waste, and abuse, including a reduction in improper Medica re fee-for-service payments (note that not all improper payments are fraudulent). Our detailed co st and benefit analysis is explained below. We specifically solicited comments on the potential increased costs and benefits associated with this provision. The following is a summary of the comments we r eceived regarding the potential increased costs and benefits associated with this provision.
Comment: Several commenters stated that if the belief is that fraud is on the physician/non-physician provider si de, then having a strong rationale for the DME equipment in their encounter note should provide the paper tr ail to determine the medical need for the DME and establish the trail of the request and just ification for each piece of DME. No additional paperwork would need to be transmitted and no interpretation of the encounter note (by nonclinician DME suppliers) would need to be done. The process could create a clear auditing trail for investigators. Response : CMS appreciates these comments; however, CMS must implement the regulation based on the statutory requirement, which is to requi re a physician to document the occurrence of a face-to-face enc ounter for covered items of DME. Through the implementation of the statutory requirements and based on commen ts, CMS tried to balan ce the need to protect the trust fund and limit burden through many ways including the list of covered items and the documentation requirements.1283

Comment: Commenters appreciated CMS’s effort s to reduce waste, fraud and abuse. Commenters stated that CMS should apply the new encounter and documentation requirements initially to a smaller number of HCPCS codes and first evaluate the impact of the requirements on beneficiary access to DME and costs to provide rs before expanding the list in the future. Response: CMS believes that this is an im portant requirement aimed at reducing waste, fraud and abuse. CMS utilized a criterion driven approach to select these items and did not receive sufficiently detailed alternative criteria to those proposed to be implementable. CMS will monitor the effects of this requirement on reducing waste, fraud and abuse and monitor beneficiary access to care. TABLE 137: Overall Economic Impact to Health Sector (in millions) Year 1 5 Years Private Sector (Paperwork Cost) $11.2 $ 64.8 Net Medicare impact of additional visits and G code billings $5 $30 Beneficiaries $14.4 $77.5 Total Economic Impact to Health Sector $ 30.6 $172.3 Note: CY 2013 only includes the first 6 months of Year 1. The definition of small entity in the RF A includes non-profit organizations. Most suppliers and providers are small en tities as that term is used in the RFA. Likewise, the vast majority of physician and NP practices are cons idered small businesses according to the Small Business Administration’s size standards with tota l revenues of $10 million or less in any 1 year. While the economic costs and benefits of this rule are substantial in the aggregate, the economic impacts on individual entities will be relatively small. We estimate that 90 to 95 percent of DME suppliers and practitioners who order DME are small entities under the RFA definition. Physicians and other professionals would receive extra payments for some of the costs imposed, and other costs (for example, for additional prac titioner visits) would be reimbursed by Medicare under regular payment rules. The rationale behind requiring a face-to-face encounter is to reduce1284 inappropriate claims from those DME suppliers who have been abusing or defrauding the program. The impact on these suppliers could be significant; however, since we believe that the purpose of the statute and this regulation is to reduce abusive and fraudulent DME sales, we do not view the burden placed on those providers and suppliers in the form of lost revenues as a condition that we must mitigate. We believe that the effect on legitimate suppliers and practitioners would be minimal. Anticipated Effects b. Costs (1) Private Sector Paperwork Costs We believe that most practitioners are al ready seeing the beneficiary no more than 6 months prior to the written order. However, this regulation potentially requires increased documentation. Although we have no quantitative data for a specific dollar figure for the additional DME that may now be authorized in accordance with §410.38(g), nor can we determine if there would be cost avoidance and a reduction of unnecessary DME, we acknowledge the potential for this provision to surpass the economically significant threshold. We do not believe that this final rule with comment period would significantly affect the number of legitimat e written orders for DME. However, we would expect a decline in fraudulent, wasteful and abusive orders, thereby causing a decrease in the amount paid for DME overall. The covered items of DME as outlined in III. C , including the list of specified covered items, contains items that meet at least one of the following four criteria: (1) items that currently require a written order prior to delivery per inst ructions in our Program Integrity Manual; (2) items that cost more than $1,000; (3) ite ms that we, based on our experience and1285 recommendations from the DME MACs, believe are pa rticularly susceptible to fraud, waste, and abuse; (4) items determined by CMS as vulnerabl e to fraud, waste and abuse based on reports of the HHS Office of Inspector General, the Govern ment Accountability Office or other oversight entities. CMS will not include items on the cove red list of items that are cited in statute explicitly as not having a f ace-to-face encounter requirement . A summary of comments regarding the criteria is available in III.C. We also have estimated the number of differe nt covered Medicare items subject to this final rule with comment period at approximately 155 HCPCS codes for items of DME. As new products enter the market this number could in crease, which could increase the impact. In addition, we propose a G-code to pay physicians for documenting the encounter conducted by a PA, a NP, or a CNS. We anticipated there would be an impact as a result of additional office visits for the face-to-face encounter and the a dditional time spent by physicians to document the face-to-face encounters with a beneficiary when it is furnished by a PA, a NP, or a CNS. In our estimate of overall cost we included the estimates from section III, of this final rule with comment period (Collection of Information Requirements section). These are estimated at $11.2 million in year 1 and $ 64.8 million over 5 years. These are driven by the physician documenting face-to-face encounters with a benefici ary when it is furnished by a PA, a NP, or a CNS, including the time to communicate the practit ioners’ findings to physicians so they can complete the necessary documentation.
TABLE 138: Private S ector Paperwork Costs Year 1 (in millions) 5 Years (in millions) Physician time to document occurrence of a face-to-face encounter cost $9.8 $57 PA, NP, or CNS costs $1.4 $7.81286

Year 1 (in millions) 5 Years (in millions) Total Cost $11.2 $64.8 Note: CY 2013 only includes the first 6 months of Year 1. (2) Medicare Costs Medicare would incur additional costs associated with this final rule with comment period related to additional face- to-face encounters in the form of office visits, and additional payment for time spent documenting the face-to-f ace encounter if furnished by the PA, NP or CNS and not by the physician directly. Subseq uently, a G-Code is being created to allow Medicare payment to physicians for documenting the face-to-face encounters that are furnished by a PA, NP, and CNS, and is included in this final rule with comment period. From a programmatic standpoint we believe that there would be 375,000 additional office visits billed and 500,000 G code claims for the doc umentation in year 1. It is difficult to determine how many PAs, NPs or CNSs wrote or ders for covered items of DME and while we lack exact empirical data, in order to provide an estimate, we assumed that 5 percent of the orders for covered items of DME were written by a PA, NP or CNS. For the purpose of this estimate, we assumed that each order requires a separate face-to-face encounter, recognizing fully that the estimate might be inflated. While we believe that currently the majority of practitioners evaluate beneficiaries before ordering DME, some may not, and therefore, a certa in number of beneficiaries would be required to have a new visit in order to fulfill the face-to -face encounter requirement. Actuarial estimates indicated approximately 2.5 percen t of those obtaining covered items of DME in a given year did not see a practitioner in the 6 months preceding the order. This percentage changed due to the modified timeframe from the proposed rule. We estimated that 250,000 be neficiaries would not see their practitioners in the 6 months prior to the written order. We assumed that 1.5 visits per1287 year per affected beneficiary would be required to cover the DME services that currently fail to meet the face- to- face requirement. The range would be about one to three; possibly less than one if many beneficiaries choose not to meet the requirement or reschedule services. DME claims for beneficiaries who failed to meet th e physician contact requirements averaged 3 line items per beneficiary. However, about 40 percent of these line items occur on the same date and so probably refer to the same event and could be authorized during a single visit. Some additional coordination is probabl e for DME purchases within a narrow time frame. To estimate the impact of the additional office visits, we assumed 375,000 additional offi ce visits (1.5 visits * 250,000 beneficiaries). We also assu med that the average cost fo r these office visits is around $65, which is consistent with a mid-level office vi sit under the PFS. This represents the total amount that the practitioners would receive, eith er from Medicare or the beneficiary, who is responsible for the 20 percent coinsurance. Physicians are now required to document the face-to-face encounter if it was furnished by a PA, NP, or CNS. In order to allow payment fo r this documentation, a G code is established for this service. There are appr oximately 10 million DME users and it we assumed that roughly 5 percent of face-to-face encounter s are actually furnished by thes e other practitioner types, thereby requiring documentation of the encounter. Therefore, we assumed that about 500,000 of these documentation services would be billed. As discussed in section III.M.3 of this final rule with comment period, we are establishing work and malpractice RVUs for HCPCS codes for G0454 by crosswalking to the work and malprac tice RVUs for CPT code 99211 ((Level 1 office or other outpatient vis it, established patient)

. With regard to practice expense RVUs, we are not including any direct practice expe nse inputs for clinical labor, di sposable medical supplies, or equipment in the direct PE input database fo r this code; practice expense RVUs will reflect1288 resources for overhead costs only. The work, ma lpractice, and practice expense RVUs for HCPCS code G0454 are reflected in Addendum B of this CY 2013 PFS final rule with comment period www.cms.gov/physicianfeesched/ . A complete list of the interim final times assigned to HCPCS code G0454 is availa ble on the CMS website at www.cms.gov/physicianfeesched/ .” This represents the total amount that the physicia n would receive, either from Medicare or the beneficiary, who is responsible for the 20 percent coinsurance. Therefore the estimated gross cost is estimated to be $10 million in CY 2013 and $115 million over 5 years; note that there are also savi ngs to Medicare that must be netted against the cost of additional practitioner office visits, whic h are described later in the Benefits section. There is a high degree of uncertainty surrounding th is estimate because it was difficult to predict how physicians and beneficiaries would respond to the new requirement. This provision would assist in providing better documenta tion which may help to lower the error rate and thus reduce improper payments , including those stemming from waste, fraud and abuse. Since there is a large amount of poten tial variation in the amount of time that a faceto-face encounter may take for an item of DME, as a proxy our estimate is based on the amount of time needed for a mid-level visit to evaluate a benefici ary (E&M code 99213). The time allotted for this visit to furnish the face-to -face evaluation under a 99213 is 15 minutes. We solicited comments as to the appropriateness of E&M Code 99213 as a proxy measure of time required for a face-to-face encounter but did not receive any public comments. Based on actual data, projecting these historical patterns in light of the draft regulation was not straight-forward. Some line items may be bundled (perhaps because they were used together). Beneficiaries may also change thei r behavior in response to the regulation. For example, beneficiaries who would be required to visit a physician in order for Medicare to pay1289 for a new piece of equipment may substitute this vis it for a later visit that would have been for a routine service. In th is situation, the overall number of vi sits would not increase. Moreover, some beneficiaries may choose not to pursue the DME item at that time. On the other hand, the final rule with comment period points out th at some of the encounters reported on the practitioner claim now may not su pport the need for the item of DME. We assume that beneficiaries would decide not to schedule 10 per cent of the additional visits required as a result of not needing the DME item and that some wo uld substitute a require d service for a later planned visit.
TABLE 139: Medicare 5-Year Costs for A dditional Face-to-Face Visits and G Code Billings 2013 2014 2015 2016 2017 $10 $25 $25 $25 $30 Note: These costs represent 80 percent of the allowed charges for the additional visits and the new G codes.
The requirement for a face-to-face encounter w ith a beneficiary in a certain time period as a condition of payment for DME is a new stat utory requirement. It is not subject to the physician fee schedule budget neut rality requirement under secti on 1848(c)(2)(B)(ii)(II) of the Act. However, by regulation, we are making an additional payment through a new G-code for physician work documenting the face-to-face enc ounters that are performed by a PA, NP, and CNS. This additional regulatory spending is subject to the physician fee schedule budget neutrality requirement under secti on 1848(c)(2)(B)(ii)(I I) of the Act. (c) Beneficiary Cost Impact From a programmatic standpoint, approximate ly 2.5 percent of those obtaining covered items of DME in that year did not see a practit ioner in the 6 months preceding the order. We estimated that 250,000 beneficiaries would not see thei r practitioners in the 6 months prior to the written order for the covered item. As mentioned above, we assumed that 1.5 visits per year per1290 affected beneficiary would be requ ired to cover the DME services that currently fail to meet the face-to-face requirement. The range would be about one to three; possibly less than one if many beneficiaries chose not to meet the requirement or reschedule services. DME claims for beneficiaries who failed to meet the physician contact requirements aver aged 3 line items per beneficiary. However, about 40 percent of th ese line items occur on the same date and so probably refer to the same event and could be au thorized during a single visit. Some additional coordination is probable for DME purc hases within a narrow time frame
. There are effects on travel time and cost for these beneficiaries. We estimate that there will be an additional 375,000 office visits as a number of beneficiaries would no t have seen their practitioner in the six months prior to the written order for the covered item. If it takes a beneficiary 1.25 hours to go to a practitioner, the total estimate is approximately 468,750 hours of tim e for this final rule with comment period. We assumed that an averag e trip requires one hour and 15 minutes (1.25 hours) (45 minutes of round trip travel time and 30 minutes in the doctor's office—half for waiting and half for time with the staff). As a proxy we use $20 to estimate the cost per hour including loss of leisure time and travel cost for a beneficiary to see a practitioner. This is consistent with previous estimates of benefi ciary leisure time as proposed in the May 4, 2011 proposed rule entitled “Medicare & Medicaid Programs; Influenza Vaccination Standard for Certain Medicare & Medicaid Participating Pr oviders and Suppliers” (76 FR 25469). This creates an economic cost of nearly $9,375,000 in year 1 and $52.5 million over 5 years. There will be additional out of pocket expenses at the 20 percent Medicare Part B coinsurance. We estimated this cost to be $5 million in year 1 and $25 million over 5 years. TABLE 140: Beneficiary Co st Impact Resulting from Additional Face-to-Face Visits to Obtain DME Services Beneficiary Cost: Out of Po cket Expense (in millions)1291

2013 2014 2015 2016 2017 $5 $5 $5 $5 $5
Year 1 5 Years Total beneficiaries visits impacted 375,000 2,100,000 Time per beneficiary 1.25 hours 1.25 hours Total Time 468,750 2,625,000 Beneficiary Time Cost ($20) $9.4 million $52,500,000 Out of Pocket Expense $5million $25,000,000 Estimated Total Beneficiary Cost Impact $ 14.4 million $ 77.5million

Note: These costs represent 20 percent of the allowed char ges for the additional visits and the new G codes. b. Benefits There would be quantifiable benefits from an expected reduction in Medicare DME services provided. In addition, we anticipated add itional, qualitative benefits from a decrease in waste, fraud, and abuse, which would decrease the number of serv ices. Further, requiring that there be a face-to-face evaluation of the beneficiar y helps ensure appropriate orders are based on the individual’s medical conditi on, which increases the quality of care that the beneficiary receives. It is difficult to m easure how much waste, fraud, and abuse will be prevented as a result of this final rule with comment period si nce it is impossible to determine what would have happened in the absence of the fi nal rule with comment period. This provision is expected to improve physician’s documentation of DME, and th erefore, will help reduce improper payments and move the agency towards its strategic goal to reduce the Medicare fee-for-service error rate for DME items, which has a higher error rate than other Medicare services. Fraud is an improper payment, but not all improper payments are fraud. Therefore, creating a measure of how much this final rule with comment period would save in terms of a reduction in waste, fraud and abuse is not possible. With that stated, in 2009 Medicare paid $1.7 billion for DME items covered by this proposed rule, and we estimated that1292 $1.9 billion would be paid for covered items in 2012, and $9.9 billion over 5 years. Preventing waste, fraud and abuse by changi ng behavior that results in just a small percentage reduction in inappropriate or unnecessary ordering of DME servic es will generate Medicare savings. This is an area where savings can be found through increased oversight We believe that the cost of the visits will be offset by the savi ngs produced by this provision. We project Medicare savings from reduced DME services; these savings partially offset the costs of additional physician office visits and documentation payments described earlier in the impact analysis. The year-to-year Medica re savings from reduced DME services is as follows: TABLE 141: Year-to-Year Medicare Savings fr om Reduced DME Services in millions
2013 2014 2015 2016 2017 DME savings -$5 -$20 -$20 -$20 -$20

Based on an analysis of 2007 DME claims, approximately 1 percent of total DME spending was for those beneficiaries who had littl e contact with their physician during the year. The gross savings to Medicare has been reduced from the estimated savings in the proposed rule due to the change in timeframe from 90 days to 6 months. We believe th at some beneficiaries who would not order a DME servic e because they did not have face-to-face visit within 90 days prior to the written order, woul d likely have a face-to-face vis it within the 6-month timeframe. For this subset of spending we assumed that there would be a 20 percent reduction in spending due to the face-to- face requirement. We f ound similar reductions in DME expenditures among managed care enrollees compared to fee-for service (FFS) benefici aries in the Medical Expenditure Panel Survey. This assumption is fairly speculative but we think it is modest compared to the estimates of improper payments across Medicare services including DME. The1293 savings would occur because some beneficiarie s would not choose to go to the physician to authorize the DME item, some physicians would not order the items that would otherwise have been provided in the absence of the regulation, a nd some suppliers would not be able to achieve a payment that might have occurred through an unnecessary sale or outright fraud. The overall net impact to Medicare of the DME face-to-face encounter policy is $5 million in the first year and $30 million over the first 5 years. This regulation produced an extr a benefit that is difficult to quantify, but is an extremely positive one in terms of greater pr actitioner involvement. By incr easing practitioner interactions with beneficiaries before ordering DME, benefi ciaries would receive more appropriate DME and benefit from higher quality care. Beneficiaries would also benefit from reduced out-of-pocket costs by not having to pay for unnecessary DME. This accomplished the objective of achieving greater practitioner accountability noted in th e provisions of and the amendments made by section 6407 and other sections of the Affordable Care Act. Alternatives Considered In this final rule with comment period, we considered a variety of options and sought comments on these options in other sections of this final rule with comment period. We expected public comment on how to limit the burd en associated with th e supplier being notified that a face-to-face encounter has occurred. We proposed several options for the physician documentation of a face-to-face encounter furn ished by that physician. We believe just submitting the medical record for the applicable date of service would create the least cost while still producing the desired bene fits. We had also proposed different options for how the physician must document the face-to-face encounter if performed by a NP, PA, or CNS. In this final rule with comment period we establish that physicians must document a face-to-face1294 encounter furnished by a PA, NP or CNS by signi ng or cosigning the pert inent portion of the medical record thereby documenting that the bene ficiary was evaluated or treated for a condition relevant to an item of DME on that date of service. Finally, there are other possible periods of tim e that could be set as the window within which face-to-face encounters must occur. We believe the 6 month timeframe for the face-toface to occur helps to best limit burden. 4. Non-Random Prepayment Review We estimated no significant budgetary impact. We believe that the overall costs for most providers and suppliers would remain the same unless they are subject to non-random prepayment complex medical review for an extended period of time. 5. Ambulance Coverage-Physicia n Certification Statement We estimated no significant budgetary impact. 6. Physician Compare Website Section IV.N.2. of this final rule with comment period addresses the background of the Physician Compare website. As described in section IV.N.2. of this final rule with comment period , we are developing aspects of the Physician Compare website using a phased approach. In the first phase, which was completed in 2011, we posted the names of those eligible professionals who satisfactorily participated in the 2009 Physician Quality Reporting System. The second phase of the plan, which was co mpleted in 2012, included posting the names of eligible professionals who were successful electronic prescr ibers under the 2009 eRx Incentive Program, as well as eligible professionals (EPs ) who participated in the EHR Incentive Program. The next phase of the plan incl uded posting of performance info rmation with respect to the 2012 Physician Quality Reporting System GPRO measures which is targeted to be completed in 2013.1295 We are finalizing proposals to include performance information for the 2013 Physician Quality Reporting System GPRO web interface meas ures data, and targeted posting this data in 2014, in addition to 2013 patient experience data for group practices participating in the 2013 Physician Quality Reporting System GPRO. As reporting of physician performance rates and patient experience data on the Physician Comp are website would be performed directly by us using the data that we collect under the 2012 Physician Quality Reporting System GPRO and other data collection methods, we did not anticipa te any notable impact on eligible professionals with respect to the posting of informa tion on the Physician Compare website. We invited but received no public comment on the Regulatory Impact Analysis related to Physician Compare and are theref ore finalizing this analysis. 7. Physician Payment, Efficiency, and Qua lity Improvements – Physician Quality Reporting System According to the 2010 Reporting Experience Report, a total of $391,635,495 in Physician Quality Reporting System (PQRS) incentives was paid by CMS for the 2010 program year, which encompassed 168,843 individual eligible professionals. In 2010, eligible professionals earned a 2.0 percent incentive (tha t is, a bonus payment equal to 2.0 percent of the total allowed part B charges for covered professional serv ices under the PFS furnished by the eligible professional during the reporting period) for sa tisfactory reporting under the PQRS. For 2013 and 2014, eligible professionals can earn a 0.5 percent incentive for sa tisfactory reporting, a reduction of 1.5 percent from 2010. Therefore, base d on 2010, which is the latest year in which PQRS has full participation data, we w ould expect that approximately $97 million (approximately 1⁄4 of $391,635,495) in incentive paym ents would be distributed to eligible professionals who satisfactorily re port. However, we expect that due to the implementation of1296 payment adjustments beginning in 2015, participati on in the PQRS would rise incrementally to approximately 300,000 eligible professionals a nd 400,000 eligible profe ssionals in 2013 and 2014, respectively. The average incentive distributed to each eligible professional in 2010 was $2,157. Taking into account the 1.5 percent incentive redu ction from 2.0 percent in 2010 to 0.5 percent in 2013 and 2014, we estimated that the average amount per eligible pr ofessional earning an incentive in 2013 and 2014 would be $539. Theref ore, we estimate that the PQRS would distribute approximately $162 million ($539 x 300,000 eligible professionals) and $216 million ($539 x 400,000 eligible professionals) in incen tive payments in 2013 and 2014, respectively. We believe these incentive payments will help offset the cost to eligible professionals for participating in the PQRS for the applicable year. Please note that, beginning 2015, incentive payments for satisfactory reporting in the PQRS will cease and payment adjustments for not satisfactorily reporting will commence. We note that the total burden associated with participating in the PQRS is the time and effort associated with indicating intent to part icipate in the PQRS, if applicable, and submitting PQRS quality measures data. When establis hing these burden estimates, we assumed the following:

• The requirements for reporting for the PQ RS 2013 and 2014 incentives and payment adjustments for 2015 and beyond would be establ ished as proposed in this 2013 Medicare
PFS final rule with comment period

.

• For an eligible professional or group pract ice using the claims, registry, or EHR-based reporting mechanisms, we assume that the e ligible professional or group practice would report on 3 measures.1297

• With respect to labor costs, we believe that a billing clerk will handle the administrative duties associated with participating, while a computer analyst will handle duties related to reporting PQRS quality measures. According to the Bureau of Labor Statistics, the mean hourly wage for a billing clerk is approxima tely $16/hour whereas the mean hourly wage for a computer analyst is approximately $40/hour. For an eligible professional who wished to participate in the PQRS as an individual, the eligible professional need not indicate his/her in tent to participate, if using the traditional reporting mechanisms. The eligible professional may simply begin reporting quality measures data. Therefore, these burden estimates for indi vidual eligible professionals participating in the PQRS are based on the traditi onal reporting mechanism the individual eligible professional chooses. However, we believe a new eligible professional or group practice would spend 5 hours—which includes 2 hours to review the PQRS measures list, review the various reporting options, and select a reporting option and measur es on which to report and 3 hours to review the measure specifications and develop a mechanism for incorporating reporting of the selected measures into their office work flows. Therefore, we believe that the initial administrative costs associated with participating in the PQRS would be approximately $80 ($16/hour x 5 hours). Traditional Claims-based Reporting Mechanism . With respect to an eligible professional who participates in the PQRS via claims, the eligible professional must gather the required information, select the appropriate quality data codes (QDC s), and include the appropriate QDCs on the claims they submit for payment. The PQRS collects QDCs as additional (optional) line items on the existi ng HIPAA transaction 837-P and/or CMS Form 1500 (OCN: 0938-0999). Based on our experience with Physician Voluntary Reporting Program (PVRP), we continued to estimate that the time needed to perform all the steps necessary to1298 report each measure via claims would range fr om 0.25 minutes to 12 minutes, depending on the complexity of the measure. Therefore, the ti me spent reporting 3 measures would range from 0.75 minutes to 36 minutes. Using an average labor cost of $40/hour, we estimated that time cost of reporting for an eligib le professional via claims woul d range from $0.50 (0.75 minutes x $40/hour) to $24.00 (36 minutes x $40/hour) per reporte d case. With respect to how many cases an eligible professional would report when using the claims-based reporting mechanism, we established that an eligible pr ofessional would need to repor t on 50 percent of the eligible professional’s applicable cases. The actual number of cases on which an eligible professional would report would vary depending on the number of the eligible professional’s applicable cases. However, in prior years, when the reporting thre shold was 80 percent, we found that the median number of reporting cases for each measure was 9. Since we reduced the reporting threshold to 50 percent, we estimated that the average numbe r of reporting cases for each measure would be reduced to 6. Based on these estimates, we es timated that the total cost of reporting for an eligible professional choosing the claims-b ased reporting mechanism would range from ($0.50/per reported case x 6 repor ted cases) $3.00 to ($24.00/reported case x 6 reported cases) $144.
Administrative Claims-bas ed Reporting Mechanism . We note that, for the 2015 PQRS payment adjustments, we are finalizing an administrative claims reporting option for eligible professionals and group practices. The burden associ ated with reporting using the administrative claims reporting option is the time a nd effort associated with using this option. To submit quality measures data for PQRS usin g the administrative claims reporting option, an eligible professional or group prac tice would need to (1) register as an administrative claims reporter for the applicable payment adjustment and (2) report quality measures data. With1299 respect to registration, we believ e it would take approximately 2 hours to register for and to participate in PQRS as an administrative claims re porter. Therefore, we estimated that the cost of undergoing the GPRO selection process would be ($16/hour x 2 hours) $32. With respect to reporting, we noted that any burden associated with reporting would be negligible, as an eligible professional or group practice woul d not be required to attach reporting G-codes on the claims they submitted. Rather, CMS would bear the bur den with respect to calculating the measure rates for claims. We noted th at there would be no additional bur den on the eligible professional or group practice to submit these claims, as the eligible professional or group practice would have already submitted these claims for reimbursement purposes. Registry-based and EHR-based Reporting Mechanisms . With respect to an eligible professional or group practice who participates in the PQRS via a qualified registry, direct EHR product, or EHR data submission vendor product, we believe there would be little to no burden associated for an eligible professional to repor t PQRS quality measures data to CMS, because the selected reporting mechanism submits the quality measures data for the eligible professional. While we note that there may be start-up costs associated with purchas ing a qualified registry, direct EHR product, or EHR data submission vendor, we believe that an eligible professional or group practice would not purchas e a qualified registry, direct EHR product, or EHR data submission vendor product solely for the purpose of reporting PQRS quality measures. Therefore, we did not include th e cost of purchasing a qualified registry, direct EHR, or EHR data submission vendor produc t in our burden estimates. The Group Practice Reporting Option . Unlike eligible prof essionals who choose to report individually, we noted that eligible professionals choosing to participate as part of a group practice under the GPRO must i ndicate their intent to participate in the PQRS as a group1300 practice. The total burden for group practices who submitted PQRS quality measures data via the proposed GPRO web-interface would be the tim e and effort associated with submitting this data. To submit quality measures data for th e PQRS, a group practice would need to (1) be selected to participate in the PQ RS GPRO and (2) report quality measures data. With respect to the administrative duties for being selected to participate in th e PQRS as a group practice, we believe it would take approximately 6 hours – incl uding 2 hours to decide whether to participate in the PQRS GPRO as a group practice, 2 hours to self-nominate, and 2 hours to undergo the vetting process with CMS officials – for a group pr actice to be selected to participate in the PQRS GPRO for the applicable year. Therefore, we estimated that the cost of undergoing the GPRO selection process would be ($16/hour x 6 hours) $96. With re spect to reporting, the total reporting burden was the time and effort associated with the group practice submitting the quality measures data (that is, completed th e data collection interf ace). Based on burden estimates for the PGP demonstration, which uses the same data submission methods, we estimated the burden associated with a group pr actice completing the data collection interface would be approximately 79 hours. Therefore, we estimated that the report cost for a group practice to submit PQRS quality measures data fo r the final reporting opti ons in an applicable year would be ($40/hour x 79 hours) $3,160. Maintenance of Certification Program Incentive . Eligible professionals who wish to quality for an additional 0.5 per cent Maintenance of Ce rtification Program incentive must “more frequently” than is required to qualify for or ma intain board certification status participate in a qualified Maintenance of Certification Program for 2013 and/or 2014 and successfully complete a qualified Maintenance of Certification Program practice assessment for the applicable year. Although we understand that there is a cost associated with part icipating in a Maintenance of1301 Certification Board, we believe that most of the eligible professionals attempting to earn this additional incentive would already be enrolled in a Mainte nance of Certification Board for reasons other than earning the additional Mainte nance of Certification Program incentive. Therefore, the burden to earn this additional incentive would depend on what a certification board establishes as “more frequently” and the ti me needed to complete the practice assessment component. We expect that the amount of time needed to complete a qualified Maintenance of Certification Program practice assessment w ould be spread out over time since a quality improvement component is often required. With respect to the practi ce assessment component, according to an informal poll conducted by ABMS in 2012, the time an individual spent to complete the practice assessment component of the Maintenance of Certification ranged from 8- 12 hours. Registry and EHR Vendors . Aside from the burden of eligible professionals and group practices participating in the PQRS, we believe that registry, direct EHR, and EHR data submission vendor products incur costs asso ciated with participating in the PQRS. Registry Vendors . With respect to qualified registri es, the total burden for qualified registries who submit PQRS quality measures data would be the time and effort associated with submitting this data. To submit quality measures data for the program years we are finalizing for PQRS, a registry would need to (1) become qualified for the a pplicable year and (2) report quality measures data on behalf of its eligible professionals. With respect to administrative duties related to the qualification process, we estimated that it will take a total of 10 hours – including 1 hour to complete th e self-nomination statement, 2 hours to interview with CMS, 2 hours to calculate numerators, denominators, and measure results for each measure the registry wishes to report using a CMS-provided meas ure flow, and 5 hours to complete an XML1302 submission – to become qualified to report PQ RS quality measures data. Therefore, we estimated that it would cost a registry a pproximately ($16.00/hour x 10 hours) $160 to become qualified to submit PQRS quality measures data on behalf of its eligible professionals. With respect to the reporting of quality measures data, we believe the burden associated with reporting was the time and effort associated with the registry calcul ating quality measures results from the data submitted to the registry by its eligible professionals, submitting numerator and denominator data on quality measures, and cal culating these measure results. We believe, however, that registries already pe rform these functions for its elig ible professionals irrespective of participating in the PQRS. Th erefore, we believe there would be little to no additional burden associated with reporting PQRS quality measures data. Whether there is any additional reporting burden will vary with each regi stry, depending on the registry’s level of savvy with submitting quality measures data for the PQRS.
EHR Vendors . With respect to EHR products, the total burden for direct EHR products and EHR data submission vendors who submit PQRS quality measures data would be the time and effort associated with submitting this data. To submit quality measures data for the proposed program years under the PQRS, a direct EHR product or EHR data submission vendor would need to report quality measures data on behalf of its eligible professionals. Please note that we are not continuing to require di rect EHR products and EHR data submission vendors to become qualified to submit PQRS quality measures data. With respect to reporting quality measures data, we believe the burden associated with the EHR vendor programming its EHR product(s) to extract the clinical data that the eligible pr ofessional must submit to CMS would depend on the vendor’s familiarity with the PQRS and the vend or’s system and programming capabilities. We believe it would take a vendor approximately 40 hours (for experienced vendors) to 200 hours1303 (for first-time vendor participan ts) to submit PQRS quality meas ures data. Therefore, we estimated that it would cost an EHR vendor ($40/hour x 40 hours) $1,600 to $8,000 to submit PQRS quality measures data for its eligible professionals.
TABLE 142: ESTIMATED COSTS FOR REPORTIN G PHYSICIAN QUALITY REPORTING SYSTEM QUALITY MEASURES DATA FOR ELIGIBLE PROFESSIONALS Estimated Hours Estimated Cases Number of Measures Hourly Rate Total Cost Individual Eligible Professional (EP): Preparation 5.0 1 N/A $16 $80 Individual EP: Claims 0.2 6 3 $40 $144 Individual EP: Administrative Claims 2 1 N/A $16 $32 Individual EP: Registry N/A 1 N/A N/A Minimal Individual EP: EHR N/ A 1 N/A N/A Minimal Group Practice: Self-Nomination 6.0 1 N/A $16 $96 Group Practice: Reporting 79 1 N/A $40 $3,160

TABLE 143: Estimated Costs to Vendors to Pa rticipate in the Physician Quality Reporting System Estimated Hours Hourly Rate Total Cost Registry: Self-Nomination 10 $40 $400 EHR: Programming 40-200 $40 $1,600 - $1,800 We invited but received no public comment on the Regulatory Impact Analysis related to PQRS and are therefore fi nalizing this analysis. 8. Electronic Prescribing (eRx) Incentive Program Please note that the requirements for becomi ng a successful electronic prescriber for the 2013 incentive and 2014 payment adjustment were established in the CY 2012 MPFS final rule with comment period. The final provisions co ntained in this CY 2013 MPFS final rule with comment period would make additional changes to the requirements for the 2013 incentive and 2014 payment adjustment for group practices. Speci fically, CMS is finalizi ng a new criterion for1304 being a successful electronic prescriber for th e 2013 incentive and 2014 payment adjustments for group practices of 2-24 eligible professionals given that CMS is modifying the definition of group practice. However, we note that any add itional impact as a result of this additional requirement would be minimal, as it is our unde rstanding the eligible pr ofessionals who would use this new reporting option are already par ticipating in the eRx Incentive Program as individual eligible professionals. For the reasons stated, the final changes w ould have no additional impact other than the impact of the 2013 and 2014 payment adjustments described in the CY 2012 MPFS final rule with comment period. We invited but receiv ed no public comment on the Regulatory Impact Analysis related to the eRx Incentive Program and are therefore finalizing this analysis. 9. Medicare Shared Savings Program Please note that the requirements for pa rticipating in the Medicare Shared Saving Program and the impacts of these requirements were established in the final rule for the Medicare Shared Savings Program that appeared in the Federal Register on November 2, 2011 (76 FR 67962). The requirements for the Medicare Shared Savings Program set forth in the CY 2013 MPFS final rule with comment period imposed requirements that eligib le professionals in group practices within acc ountable care organizations would n eed to satisfy for purposes of the PQRS payment adjustment under th e Medicare Shared Savings Pr ogram as the proposals related to the ACOs for the PQRS payment adjustment mi rror the requirements that were established for earning the PQRS incentives. We invited but received no public comment on the Regulatory Impact Analysis related to the Medicare Shared Savings Program and are therefore finalizing this analysis. 10. Medicare EHR Incentive Program1305 Please note that the requirements for repor ting clinical quality measures (CQMs) to achieve meaningful use under the EHR Incentive Progr am were established in a standalone final rule published on July 28, 2010 (75 FR 44544) and September 4, 2012 (77 FR 53968). The requirements contained in this CY 2013 MPFS fi nal rule with comment period merely propose methods to report CQMs for purposes of achie ving meaningful use under the EHR Incentive Program. Therefore, the impacts of the extens ion of the use of attestation and the PQRSMedicare EHR Incentive Pilot to report CQMs were absorbed in the impacts discussion published in the EHR Incentive Program final rules published on July 28, 2010 and September 4,
2012. We invited but received no public comment on the Regulatory Impact Analysis related to The Medicare EHR Incentive Program and are therefore finalizing this analysis. 11. Chiropractic Services Demonstration As discussed in section III of this final rule with comment period, we continue the recoupment of the $50 million in expenditures from this demonstration in order to satisfy the BN requirement in section 651(f)(1)(B) of the MMA. We initiated this recoupment in CY 2010 and this will be the fourth year. As discussed in the CY 2010 PFS final rule with comment period, we finalized a policy to recoup $10 million each year through adjustments to the PFS for all chiropractors in CY s 2010 through 2014. To impl ement this required BN adjustment, we are recouping $10 million in CY 2013 by reducing the payment amount under the PFS for the chiropractic CPT codes (that is, CPT codes 98940, 98941, and 98942) by approximately 2 percent. 12. Physician Value-Based Payment Modifier an d the Physician Feedback Reporting Program The Physician Value-Based Payment Modifier and the Physician Feedback Program final1306 policies discussed in section IV .I. of this final rule with comment period would not impact CY 2013 physician payments under the PFS. Howeve r, we expect that our proposals to use the PQRS quality measures in the Physician Feedback reports and in the value-based payment modifier to be implemented in CY 2015 may resu lt in increased particip ation in the PQRS in CY 2013. We anticipate that as we approach implementation of the value-based payment modifier, physicians would increasingly particip ate in the PQRS to determine and understand how the value-based payment modifi er could affect their payments. 13. Medicare Coverage of Hepatitis B Vaccine: Modification of high risk groups eligible for Medicare Part B coverage of Hepatitis B vaccine. As discussed in section III of this final ru le with comment period, section 1861(s)(10)(B) of the Act authorizes Medicare coverage of hepa titis B vaccine and its ad ministration if furnished to an individual who is at high or intermediate risk of contracting hepatitis B, as determined by the Secretary under regulations. Our current re gulations are established at 42 CFR §410.63. We proposed to modify §410.63(a)(1) by adding persons diagnosed with diabetes mellitus to the high risk group. While it is estimated that approxim ately 23 percent of non-in stitutionalized Medicare beneficiaries are diagnosed with diabetes mellitus, it is unclear how many of these beneficiaries would obtain these services. Therefore, the estim ated impact of adding persons diagnosed with diabetes mellitus to the high risk group eligible for coverage of hepatitis B vaccine and its administration is unknown for CY 2013. 14. Existing Standards for E-pres cribing under Medicare Part D a nd Identification and Lifting the LTC Exemption The e-prescribing standard updates that are adopted in this fina l rule with comment period impose no new requirements as the burden of using the updated standards is anticipated to1307 be the same as using the old standards. We belie ve that prescribers and dispensers that are now e-prescribing largely invested in the hardwa re, software, and connect ivity necessary to eprescribe. We do not anticipate that the reti rement of NCPDP SCRIPT 8.1 in favor of NCPDP SCRIPT 10.6 will result in significant costs. Nor do we believe that the eventual retirement of the NCPDP Formulary and Benefit 1.0 and the adoption of the updates for NCPDP Formulary and Benefits 3.0 as the official Part D sta ndard will result in significant costs. The removal of the LTC exception to the NCPDP SCRIPT standard would impose a small burden on the LTC industry. LTC entities w ho use and developed proprietary solutions may need to invest in software programming updat es if they had not al ready incorporated the Part D e-prescribing standards in their solutions. It is reasonable to assume that a small number of proprietary solutions would have to be m odified to enable adhe rence to the adopted eprescribing standards. Other co sts may be incurred through sta ff training on the use of the eprescribing standards and the use of any e-pr escribing solution adopted by a LTC facility. Additional training cost may invol ve prescribers and dispensers learning the new workflows that an electronic prescription may or may not require. I. Alternatives Considered This final rule with comment period cont ains a range of policies, including some provisions related to specific statutory pr ovisions. The preceding preamble provided descriptions of the statutory provisions that are addressed, identified those policies when discretion has been exercised, presented rationa le for our final policies and, where relevant, alternatives that were considered. J. Impact on Beneficiaries There are a number of changes in this final rule with comment period that would have an1308 effect on beneficiaries. In genera l, we believe that many of the ch anges adopted in this final rule with comment period, including the refinements of the PQRS with its focus on measuring, submitting, and analyzing quality data; establishing the value-based payment modifier to adjust physician payment beginning in CY 2015; creating a separate payment for post-discharge transitional care management services in the 30 days after a beneficiary has been discharged from an inpatient hospital admission, from outpatient observation services and partial hospitalization program, from a SNF, or from a CMHC; improved accuracy in payment through revisions to the inputs used to calculate paym ents under the PFS for cer tain radia tion therapy services; capital interest rate assumptions; multiple procedure payment reduction for ophthalmology and cardiovascular diagnostic tests; revised values for many services identified through the misvalued codes initiative, and revisi ons to payment for Part B drugs would have a positive impact and improve the quality and value of care furnished to Medicare beneficiaries. Most of the aforementioned policy changes could result in a change in beneficiary liability as it rela tes to coinsurance (which is 20 percent of the fee sche dule amount if applicable for the particular provision after the beneficiary has met the deductible). To illustrate this point, as shown in Table 136, the CY 2012 national paym ent amount in the nonfaci lity setting for CPT code 99203 (Office/outpatient visit, new) is $105.18 which means th at in CY 2012 a beneficiary would be responsible for 20 per cent of this amount, or $21.04. Ba sed on this final rule with comment period, using the current (CY 2012) CF of 34.0376, the CY 2013 national payment amount in the nonfacility sett ing for CPT code 99203, as shown in Table 136, is $107.80, which means that, in CY 2013, the proposed beneficiar y coinsurance for this service would be $21.56. Payment amounts and associated coinsurance woul d be lower using the current law CY 2013 CF with the negative SGR adjustment.1309 The transitional care management policy would also have an impact on beneficiary coinsurance for those beneficiarie s who have a hospital visit in CY 2013 and require moderate to high complexity decision-making by their commun ity physician in the 30 days post discharge. Prior to the new TCM policy discussed in section III.H. of this final rule with comment period such a recently discharged beneficiary may have ha d an established patient follow-up visit with their community physician. The CY 2013 national pa yment amount in the nonfacility setting for CPT code 99215 (Office/outpatient vis it, established), the highest le vel of an established patient office visit, is $142.96, which means that a benefi ciary would be responsible for 20 percent of this amount, or $28.59. Under the new transitional care management policy, if a beneficiary received the highest level tr ansitional care management vis it, 99496, which has a national payment amount of $231.11, the beneficiary would be responsible for 20 percent of this amount, or $46.22 K. Accounting Statement As required by OMB Circul ar A-4 (available at http://www.whitehouse.gov/om b/circulars/a004/a-4.pdf ), in Tables 144 and 145 (Accounting Statement), we have prepared an accounting statement showing the estimated expenditures associated with this final rule with comment period. This estimate includes the estimated FY 2012 cash benefit impact associated with certain Affordable Care Act and MCTRJCA provisions, and the CY 2013 incurr ed benefit impact associated with the estimated CY 2013 PFS conversion factor update based on the Mid-Sessi on Review of the FY 2013 President's Budget baseline.1310
TABLE 144: Accounting Statement: Cla ssification of Estimated Expenditures

CATEGORY TRANSFERS

CY 2013 Annualized Monetized Tran sfers Estimated decrease in expenditures of $24.8 billion for PFS conversion factor update From Whom To Whom? Federal Government to physicians, other p ractitioners and providers and suppliers who receive p ayment under Medicare. CY 2013 Annualized Monetized Transfers Estim ated increase in payment of 162 millions From Whom To Whom? Federal Govern ment to eligible professionals p articipated in (Physician Quality Reporting System (PQRS)

TABLE 145: Accounting Statement: Classification of Estimate d Costs, Transfer, and Savings in CY 2013($ In Millions)
CATEGORY BENEFIT

Qualitative (unquantified) benefits of fraud, waste, and abuse prevented, and of improved quality of services to patients improved quality of services to patients N o precise estimate available

CATEGORY COST

Costs associated with DME face-to-face encounters and written orders prior to delivery $30.6 million* Qualitative costs of reporting PQRS quality measures data for eligible professionals and for vendors to participate in the PQRS N o precise estimate available

* It includes the monetized costs of beneficiary travel time ($9.4 million), out of pocket expenses ($5 million), private sector paperwork costs ($11.2 m illion), and the increased Medicare payment to the providers associated with the additional visits and G code billings ($5 million). L. Conclusion The analysis in the previous sections, toge ther with the remainder of this preamble, provides an initial “Regulator y Flexibility Analysis.” In accordance with the provisions of Executive Order 12866, this regulation was reviewed by the Office of Management and Budget.1311
List of Subjects
42 CFR Part 410 Health facilities, Health pr ofessions, Kidney diseases, Labor atories, Medicare, Reporting and recordkeeping requirements, Rural areas, X-rays.
42 CFR Part 414 Administrative practice and pr ocedure, Health facilities, Health professions, Kidney diseases, Medicare, Reporting and recordkeeping requirements.
42 CFR Part 415 Health facilities, Health professions , Medicare, Reporting and recordkeeping requirements.
42 CFR Part 421 Administrative practice and pro cedure, Health facilities, H ealth professions, Medicare, Reporting and recordkeeping requirements.
42 CFR Part 423 Administrative practice and pr ocedure, Emergency medical se rvices, Health facilities, Health maintenance organizations (HMO). Hea lth professionals, Incor poration by reference, Medicare, Penalties, Privacy, Reporti ng and recordkeeping requirements.
42 CFR Part 425 Administrative practice and pro cedure, Health facilities, H ealth professions, Medicare, Reporting and recordkeeping requirements.
42 CFR Part 486 Grant programs-health, Health facilities, Medicare, Reporting and recordkeeping requirements, X-rays.1312

42 CFR Part 495 Administrative practice and pro cedure, Electronic health record s, Health facilities, Health professions, Health maintenance organizations (H MO), Medicaid, Medicare, Penalties, Privacy, Reporting and recordkeeping requirements.1313

For the reasons set forth in the preamble, the Centers for Medicar e & Medicaid Services amend 42 CFR chapters IV as set forth below: PART 410--SUPPLEMENTARY MEDICAL INSURANCE (SMI) BENEFITS 1. The authority citation for part 41 0 continues to read as follows: Authority : Secs. 1102, 1834, 1871, 1881, and 1893 of the Social Security Act (42 U.S.C. 1302. 1395m, 1395hh, and 1395ddd. 2. Section 410.26 is amended by adding new paragraph (b)(8) to read as follows: §410.26 Services and supplies incident to a physi cian's professional services: Conditions. * * * * * (b) * * * (8) Claims for drugs payable administered by a physician as defined in section 1861(r) of the Social Security Act to refill an implanted it em of DME may only be paid under Part B to the physician as a drug incident to a physician’s service under section 1861(s)(2)(A). These drugs are not payable to a pharmacy/supplier as DM E under section 1861(s)(6 ) of the Act.
* * * * *
3. Section 410.32 is amended by-- A. Revising paragraphs (b)(2)(iii) in troductory text, (d)(2)(i), and (e). B. Redesignating paragraphs (c)(2) and (c )(3) as paragraphs (c)(3) and (c)(4), respectively. C. Adding new paragraph (c)(2) The revisions and addition read as follows: § 410.32 Diagnostic x-ray tests, diagnostic labo ratory tests, and other diagnostic tests:
Conditions.1314

* * * * * (b) * * * (2) * * * (iii) Diagnostic psycholog ical and neuropsychological testing services when—
* * * * * (c) * * * (2) These services are ordered by a physic ian as provided in pa ragraph (a) or by a nonphysician practitioner as provided in paragraph (a)(2) of this section.
* * * * * (d) * * * (2) * * * (i) Ordering the service

. The physician or (qualified nonphysi can practitioner, as defined in paragraph (a)(2) of this section), who orde rs the service must maintain documentation of medical necessity in the be neficiary's medical record.
* * * * * (e) Diagnostic laboratory te sts furnished in hospitals and CAHs. The provisions of paragraphs (a) and (d)(2) through (d )(4) of this section, inclusive, of this section apply to all diagnostic laboratory test furnished by hospitals and CAHs to outpatients. §410.37 [Amended.] 4. Amend §410.37 by-- A. Amending paragraph (a)(1)( iii) by removing the phrase “In the case of an individual at high risk for colorectal cancer,” and by rem oving “screening” and adding “Screening” in its place.1315 B. Removing paragraph (g)(1). C. Redesignating paragraphs (g)(2) through (g)(4) as paragraph (g)(1) through (g)(3), respectively. D. In newly redesignated paragraph (g)(1), removing the reference “(g)(4)” and adding in its place the reference “(g)(3)”. 5. Section 410.38 is amended by revising paragraph (g) to read as follows: §410.38 Durable medical equipment: Scope and conditions. * * * * * (g)(1) Items requiri ng a written order . As a condition of payment, Specified Covered Items (as described in paragraph (g)(2) of this section) require a written order that meets the requirements in paragraphs (g)(3) and (4) of th is section before delivery of the item. (2) Specified covered items . (i) Specified Covered Items are items of durable medical equipment that CMS has specified in accordance with section 1834(a)(11)(B)(i) of the Act. A list of these items is updated annually in the Federal Register

. (ii) The list of Specified C overed Items includes the following: (A) Any item described by a Healthcare Common Procedure Coding System ( HCPCS ) code for the following types of durable medical equipment: (1 ) Transcutaneous electrical ne rve stimulation (TENS) unit. (2 ) Rollabout chair. (3 ) Oxygen and respiratory equipment. (4 ) Hospital beds and accessories. (5 ) Traction-cervical. (B) Any item of durable medical equipm ent that appears on the Durable Medical1316 Equipment, Prosthetics, Orthotics, and Supplies Fee Schedule with a pric e ceiling at or greater than $1,000. (C) Any other item of durable medical equipm ent that CMS adds to the list of Specified Covered Items through the notice and comment rulema king process in order to reduce the risk of fraud, waste, and abuse. (iii) The list of specific cove red items excludes the following: (A) Any item that is no longer covered by Medicare. (B) Any HCPCS code that is discontinued. (3) Face-to-face encounter requirements . (i) For orders issued in accordance with paragraphs (g)(1) and (2) of this section, as a condition of payment for the Specified Covered Item, all of the following must occur: (A) The physician must document and co mmunicate to the DME supplier that the physician or a physician assistant, a nurse practiti oner, or a clinical nurse specialist has had a face-to-face encounter with the beneficiary on the da te of the written order up to 6 months before the date of the written order. (B) During the face-to-face encounter the physician, a physician as sistant, a nurse practitioner, or a clinical nurse specialist must conduct a needs asse ssment, evaluate, and/ or treat the beneficiary for the medical condition that supports the need for each covered item of DME ordered. (C) The face-to-face encounter must be doc umented in the pertinent portion of the medical record (for example, history, physical examination, diagnostic tests, summary of findings, diagnoses, treatment plans or other info rmation as it may be appropriate). Physician must sign or cosign the pertinen t portion of the medical record indicating the occurrence of a1317 face-to-face encounter for the beneficiary for the date of the face- to-face encounter when performed by a physician assistant, a nurse practitioner, or a c linical nurse specialist. For purposes of this paragraph (g), a face-to-fa ce encounter does not include DME items and services furnished from an "incident to" service. (ii) For purposes of this paragraph (g), a face-to-face encounter may occur via telehealth in accordance with all of the following: (A) Section 1834(m) of the Act. (B)(1 ) Medicare telehealth re gulations in §410.78 and §414.65 of this chapter; and (2 ) Subject to the list of payable Medicare telehealth services established by the applicable PFS. (4) Written order issuance requirements . Written orders issued in accordance with paragraphs (g)(1) and (2) of this sect ion must include a ll of the following: (i) Beneficiary's name. (ii) Item of DME ordered. (iii) Signature of the prescribing practitioner. (iv) Prescribing practitioner NPI (v) The date of the order. (5) Supplier's order and documentation requirements . (i) A supplier must maintain the written order and the supporting documentation provided by the physician, physician assistant, nurse practitioner, or c linical nurse specialist and make th em available to CMS upon request for 7 years from the date of service consis tent with §424.516(f) of this chapter. (ii) Upon request by CMS or its agents, a supplier must submit additional documentation to CMS or its agents to suppor t and substantiate that a face- to-face encounter has occurred.1318 6. Section 410.40 is amended by-- A. In paragraph (c)(3)(ii), the word “fro” is revised to read “from.” B. Redesignating paragraph (d)(2) as (d)(2)(i). C. Adding paragraph (d)(2)(ii). The addition reads as follows: §410.40 Coverage of ambulance services. * * * * * (d) * * * (2) * * * (ii) In all cases, the provider or supplier must keep appropriate documentation on file and, upon request, present it to the contractor. Th e presence of the signed physician certification statement does not alone demonstrate that the ambulance transport was me dically necessary. All other program criteria must be met in order for payment to be made.
* * * * * 7. Section 410.59 is amended by adding paragraph (a)(4) to read as follows: §410.59 Outpatient occupational therapy services: Conditions. (a) * * * (4) Claims submitted for furnished services contain prescribed information on patient functional limitations.
* * * * * 8. Section 410.60 is amended by adding paragraph (a)(4) to read as follows: § 410.60 Outpatient physical therapy services: Conditions. (a) * * *1319 (4) Claims submitted for furnished services contain prescribed information on patient functional limitations.
* * * * * 9. Section 410.61 is amended by revising paragraph (c) to read as follows: §410.61 Plan of treatment requirements fo r outpatient rehabilitation services. * * * * * (c) Content of the plan

. The plan prescribes the type, amount, frequency, and duration of the physical therapy, occupational therapy, or speech-language pathology services to be furnished to the individual, and indicates the diagnosis and anticipated goals that are consistent with the patient function reporti ng on claims for services.
* * * * * 10. Section 410.62 is amended by adding para graph (a)(4) to read as follows: § 410.62 Outpatient speech-language-pathol ogy services: Conditions and exclusions. (a) * * * (4) Claims submitted for furnished services contain prescribed information on patient functional limitations.
* * * * * 11. Section 410.63 is amended by-- A. Removing “and” from the end of paragraph (a)(1)(vi). B. Removing the period from the end of pa ragraph (a)(1)(vii) and a dding “; and” in its place. C. Adding paragraph (a)(1)(viii). The addition reads as follows:1320
§410.63 Hepatitis B vaccine and blood clotting factors: Conditions. * * * (a) * * * (1) * * * (viii) Persons diagnosed with diabetes mellitus.

* * * * * 12. Section 410.69 is amended in paragraph (b ) by adding the definition of “Anesthesia and related care” in alphabetical order to read as follows: §410.69 Services of a certified regist ered nurse anesthetist or an anesthesiologist's assistant: Basic rule and definitions.
* * * * * (b) * * * Anesthesia and related care means those services that a certified registered nurse anesthetist is legally authorized to perform in the state in which the services are furnished. .* * * * * 13. Section 410.78 is amended by revising the intr oductory text of paragraph (b) to read as follows: §410.78 Telehealth services. * * * * * (b) General rule . Medicare Part B pays for office or other outpatient visits, subsequent hospital care services (with the limitation of one telehealth visi t every 3 days by the patient’s admitting physician or practitioner), subsequent nurs ing facility care services (not including the Federally-mandated periodic visits under §483.40(c) of this chap ter and with the limitation of one telehealth visit every 30 days by the patient’s admitting physician or nonphysician1321 practitioner), professional consultations, ps ychiatric diagnostic interview examination, neurobehavioral status exam, individual psyc hotherapy, pharmacologic management, end-stage renal disease-related services included in the monthly capitation payment (except for one “hands on” visit per month to examine the access site), individual and group medical nutrition therapy services, individual and group kidne y disease education services, i ndividual and group diabetes self-management training services (except for one hour of “hands on” services to be furnished in the initial year training period to ensure effective injection training), individual and group health and behavior assessment and intervention serv ices, smoking cessation services, alcohol and/or substance abuse and brief in tervention services, screeni ng and behavioral counseling interventions in primary care to reduce alcoho l misuse, screening for depression in adults, screening for sexually transmitted infections (S TIs) and high intensity behavioral counseling (HIBC) to prevent STIs, intensive behavioral th erapy for cardiovascular disease, and behavioral counseling for obesity furnished by an interact ive telecommunications system if the following conditions are met:
* * * * * 14. Section 410.105 is amended by-- A. Revising paragraph (c)(1)(ii). B. Adding new paragraph (d). The revision and addition read as follows: §410.105 Requirement for coverage of CORF services. * * * * * (c) * * * (1) * * *1322 (ii) Prescribes the type, amount , frequency, and duration of th e services to be furnished, and indicates the diagnosis and antic ipated rehabilitation goals that are consistent with the patient function reporting on the claims for services.
* * * * *(d) Claims submitted for physical therapy, occupational therapy or speech-languagepathology services, contain pres cribed information on patient functional limitations. 15. Section 410.160 is amended by revising pa ragraph (b)(8) to read as follows: §410.160 Part B annual deductible. * * * * * (b) * * * (8) Beginning January 1, 2011, a su rgical service furnished in connection with, as a result of, and in the same clinical enc ounter as a planned colorectal can cer screening test. A surgical service furnished in connection wi th, as a result of, and in the same clinical encounter as a colorectal cancer screening test means—a surg ical service furnished on the same date as a planned colorectal cancer screen ing test as described in §410.37.
* * * * *
PART 414--PAYMENT FOR PART B MEDI CAL AND OTHER HEALTH SERVICES 16. The authority citation for part 414 continues to read as follows: Authority : Secs. 1102, 1871, and 1881(b)(l) of the So cial Security Act (42 U.S.C. 1302, 1395hh, and 1395rr(b)(l)). 17. Section 414.65 is amended by revising pa ragraph (a)(1) to read as follows: §414.65 Payment for telehealth services. (a) * * *1323 (1) The Medicare payment amount for office or other outpatient visits, subsequent hospital care services (with the limitation of one telehealth visi t every 3 days by the patient’s admitting physician or practitioner), subsequent nu rsing facility care serv ices (with the limitation of one telehealth visit every 30 days by the patient’s admitting physician or nonphysician practitioner), professional consultations, ps ychiatric diagnostic interview examination, neurobehavioral status exam, individual psyc hotherapy, pharmacologic management, end-stage renal disease-related services included in the monthly capitation payment (except for one “hands on” visit per month to examine the access site), individual and group medical nutrition therapy services, individual and group kidne y disease education services, i ndividual and group diabetes self-management training services (except for one hour of “hands on” services to be furnished in the initial year training period to ensure effective injection training), individual and group health and behavior assessment and intervention, smoking cessation services, alcohol and/or substance abuse and brief intervention services, screeni ng and behavioral counseling interventions in primary care to reduce alcohol misuse, screening for depression in adults, screening for sexually transmitted infections (STIs) and high intensity behavioral counseling (HIBC) to prevent STIs, intensive behavioral therapy for cardiovascular disease, and behavioral counseling for obesity furnished via an interactive telecommunications system is equal to the current fee schedule amount applicable for the service of the physician or practitioner. (i) Emergency department or initia l inpatient telehealth consultations

. The Medicare payment amount for emergency department or initia l inpatient telehealth consultations furnished via an interactive tel ecommunications system is equal to the current fee schedule amount applicable to initial ho spital care provided by a phys ician or practitioner.1324 (ii) Follow-up inpatient telehealth consultations

. The Medicare payment amount for follow-up inpatient telehealth consultations furnished via an interactive telecommunications system is equal to the current fee schedule amount applicable to subsequent hospital care provided by a physician or practitioner.
* * * * * 18. Section 414.90 is amended by-- A. In paragraph (b), revising the definiti ons “Group practice” and “Qualified registry.” B. In paragraph (b), removing the term “Qualified electronic h ealth record product”. C. In paragraph (b), adding the definitions “Administrative claims ,” “Direct electronic health record (EHR) product,” “Electronic h ealth record (EHR) data submission vendor product,” and “Group practice reporting option (G PRO) web interface” in alphabetical order. D. Revising paragraphs (c) and (d). E. Redesignating paragraphs (e), (f ), (g), (h), (i), and (j) as para graphs (f), (g), (i), (j), (k), and (l), respectively. F. Adding new paragraphs (e) and (h). G. Revising newly designated para graphs (f), (g), (i), and (j). The revisions and additions read as follows: §414.90 Physician Quality Reporting System. * * * * * (b) * * * Administrative claims means a reporting mechanism under which an eligible professional or group practice uses claims to report data on the proposed PQRS quality measures. Under this reporting mechanism, CMS analyzes claims data to determine which measures an eligible1325 professional or group practice reports. Direct electronic health record (EHR) product means an electronic health record vendor's product and version that submits data on Physicia n Quality Reporting System measures directly
to CMS. Electronic health record (EHR) data submission vendor product means an entity that receives and transmits data on Physician Qual ity Reporting System m easures from an EHR product to CMS.
* * * * * Group practice means a physician group practice that is defined by a TIN, with 2 or more individual eligible professionals (or, as identified by NPIs) that has reassigned thei r billing rights to the TIN. Group practice reporting op tion (GPRO) web interface means a web product developed by CMS that is used by group practices that are selected to participate in the group practice reporting option (GPRO) to submit data on Physician Quality Reporting System quality

measures. * * * * * Qualified registry means a medical registry or a ma intenance of certification program operated by a specialty body of the American Board of Medical Specialties that, with respect to a particular program year, has self-nominated a nd successfully completed a vetting process (as specified by CMS) to demonstrate its complian ce with the Physician Quality Reporting System qualification requirements specified by CMS for th at program year. The registry may act as a data submission vendor, which has the requisite legal authority to provide Physician Quality Reporting System data (as specified by CMS) on beha lf of an eligible professional to CMS. If1326 CMS finds that a qualified registry submits gr ossly inaccurate data for reporting periods occurring in a particular year, CMS reserves the right to disqualify a registry for reporting periods occurring in th e subsequent year.
* * * * * (c) Incentive payments

. For 2007 to 2014, with respect to covered professi onal services furnished during a reporting period by an eligible pr ofessional, an eligible professional (or in the case of a group practice under para graph (i) of this section, a group practice) may receive an incentive if -- (1) There are any quality measures that have been established under the Physician Quality Reporting System that are applicable to any such services furnished by such professional (or in the case of a group practi ce under paragraph (i) of this section, such group practice) for such reporting period; and (2) If the eligible professi onal (or in the case of a group practice under paragraph (j) of this section, the group practice) sa tisfactorily submits (as determin ed under paragraph (g) of this section for the eligible professiona l and paragraph (i) of this section for the group practice) to the Secretary data on such quality measures in a ccordance with the Physician Quality Reporting System for such reporting period, in addition to the amount othe rwise paid under section 1848 of the Act, there also must be paid to the eligible professional (or to an employer or facility in the cases described in section 1842(b)(6)(A) of th e Act or, in the case of a group practice under paragraph (i) of this section, to the group practice) from the Federal Supplementary Medical Insurance Trust Fund established under secti on 1841 of the Act an amount equal to the applicable quality percent (as specified in paragr aph (c)(3) of this sect ion) of the eligible professional's (or, in the case of a group practice under paragra ph (i) of this section, the group1327 practice's) total estimated allowed charges for al l covered professional se rvices furnished by the eligible professional (or, in th e case of a group practice under para graph (i) of this section, by the group practice) during the reporting period. (3) The applicable quality percent is as follows: (i) For 2007 and 2008, 1.5 percent. (ii) For 2009 and 2010, 2.0 percent. (iii) For 2011, 1.0 percent. (iv) For 2012, 2013, and 2014, 0.5 percent. (4) For purposes of this paragraph (c) -- (i) The eligible professional's (or, in the case of a group pr actice under para graph (i) of this section, the group practice' s) total estimated allowed charges for covered professional services furnished during a reporting period are determined based on claims processed in the National Claims History (NCH) no later than 2 m onths after the end of the applicable reporting period; (ii) In the case of the eligible professional who furnishes covered professional services in more than one practice, incentive payments are separately determined for each practice based on claims submitted for the eligible professional for each practice; (iii) Incentive payments to a group practice unde r this paragraph must be in lieu of the payments that would otherwise be made under the Physician Quality Reporting System to eligible professionals in the gr oup practice for meeting the criteria for satisfactory reporting for individual eligible professionals . For any program year in whic h the group practice (as identified by the TIN) is selected to participate in th e Physician Quality Reporting System group practice reporting option, the eligible pr ofessional cannot individually qualify for a Physician Quality1328 Reporting System incentive payment by meeting the requirements specified in paragraph (g) of this section. (iv) Incentive payments earne d by the eligible professiona l (or in the case of a group practice under paragraph (i) of th is section, by the group practice) for a particular program year will be paid as a single consolidated payment to the TIN holder of record. (d) Additional incentive payment

. Through 2014, if an eligible professional meets the requirements described in paragraph (d)(2) of this section, the applicable percent for such year, as described in paragraphs (c)(3) (iii) and (iv) of this section, mu st be increased by 0.5 percentage points. (1) In order to qualify for the additional in centive payment described in paragraph (d) of this section, an eligible pr ofessional must meet all of the following requirements: (i) Satisfactorily submits data on quality meas ures for purposes of this section for the applicable incentive year. (ii) Have such data submitted on their beha lf through a Maintenan ce of Certification program (as defined in paragraph (b ) of this section) that meets: (A) The criteria for a regist ry (as specified by CMS); or (B) An alternative form and manner determined appropriate by the Secretary. (iii) The eligible professional, more frequently than is required to qualify for or maintain board certification status— (A) Participates in a maintenance of certificat ion program (as defined in paragraph (b) of this section) for a year; and (B) Successfully completes a qualified main tenance of certification program practice assessment (as defined in paragraph (b) of this section) for such year.1329 (2) In order for an eligible professional to receive the additional incentive payment, a Maintenance of Certification Pr ogram must submit to the Secret ary, on behalf of the eligible professional, information— (i) In a form and manner specified by the S ecretary, that the eligible professional has successfully met the requirements of paragraph (d)(1)(iii) of this section, which may be in the form of a structural measure. (ii) If requested by the Secretary, on the survey of patient experience with care. (iii) As the Secretary may require, on the methods, measures, and data used under the Maintenance of Certification Pr ogram and the qualified Maintena nce of Certification Program practice assessment. (e) Payment adjustments . For 2015 and subsequent years, with respect to covered professional services furnished by an eligible pr ofessional, if the eligib le professional does not satisfactorily submit data on quality measures fo r covered professional services for the quality reporting period for the year (as determined unde r section 1848(m)(3)(A) of the Act), the fee schedule amount for such services furnished by su ch professional during th e year (including the fee schedule amount for purposes for determinin g a payment based on such amount) shall be equal to the applicable percent of the fee schedule amount that would otherwise apply to such services under this subsection. (1) The applicable percent is as follows: (i) For 2015, 98.5 percent; and (ii) For 2016 and each subsequent year, 98 percent. (2) [Reserved.] (f) Use of consensus-based quality measures

. For measures selected for inclusion in the1330 Physician Quality Reporting System quality measure set, CMS will use consensus-based quality measures that meet one of the following criteria: (1) Be such measures selected by the Secret ary from measures that have been endorsed by the entity with a contract with the Secretary under se ction 1890(a) of the Act. (2) In the case of a specified area or medi cal topic determined appropriate by the Secretary for which a feasible and practical m easure has not been endorsed by the entity with a contract under section 1890(a) of the Act, the Secretary may specify a measure that is not so endorsed as long as due considerat ion is given to meas ures that have been endorsed or adopted by a consensus organization identified by the Secretary. (3) For each quality measure adopted by the Secretary under this paragraph, the Secretary ensures that eligible professiona ls have the opportunity to provid e input during the development, endorsement, or selection of quality measures applicable to services they furnish. (g) Requirements for the incentive payments . In order to qualify to earn a Physician Quality Reporting System incentive payment for a pa rticular program year, an individual eligible professional, as identified by a unique TIN/NPI combination, (or in the case of a group practice under paragraph (i) of this section, by the group pr actice) must meet the criteria for satisfactory reporting specified by CMS for such year by repo rting on either individual Physician Quality Reporting System quality measures or Physicia n Quality Reporting System measures groups identified by CMS during a reporting period specif ied in paragraph (g)(1) of this section and using one of the reportin g mechanisms specified in paragrap h (g)(2) or (g)(3) of this section. (1) Reporting periods

. For purposes of this paragra ph, the reporting period is— (i) The 12-month period from January 1 th rough December 31 of such program year. (ii) A 6-month period from July 1 through December 31 of such program year.1331 (A) For 2011, such 6-month re porting period is not available for EHR-based reporting of individual Physician Quality Re porting System quality measures. (B) For 2012 and subsequent program years, such 6-month reporting period from July 1 through December 31 of such program year is on ly available for regist ry-based reporting of Physician Quality Reporting System measures groups by eligible professionals

. (2) Reporting mechanisms for i ndividual eligible professionals . An individual eligible professional who wishes to participate in the Physician Quality Reporting System must report information on Physician Quality Reporting System quality measures identified by CMS in one of the following manners: (i) Claims . Reporting Physician Quality Reporting Sy stem quality measures or Physician Quality Reporting System measures groups to CM S, by no later than 2 months after the end of the applicable reporting period, on the eligible prof essional's Medicare Part B claims for covered professional services furnished durin g the applicable reporting period. (A) If an eligible professional re-submits a Medicare Part B claim for reprocessing, the eligible professional may not att ach a G-code at that time for re porting on individual Physician Quality Reporting System measures or measures groups. (B) [Reserved] (ii) Registry . Reporting Physician Quality Reporti ng System quality measures or Physician Quality Reporting System measures groups to a qualified regist ry (as specified in paragraph (b) of this section) in the form and manner and by the d eadline specified by the qualified registry selected by the eligible prof essional. The selected registry must submit information, as required by CMS, for covered pr ofessional services furn ished by the eligible professional during the applicable reporting period to CMS on the el igible professional's behalf.1332 (iii) Direct EHR product. Reporting Physician Quality Reporting System quality measures to CMS by extracting clinical data us ing a secure data submission method, as required by CMS, from a direct EHR product (as defined in paragraph (b) of this section) by the deadline specified by CMS for covered prof essional services furnished by th e eligible professional during the applicable re porting period. (iv) EHR data submission vendor

. Reporting Physician Quality Reporting System quality measures to CMS by extracting clinical data us ing a secure data submission method, as required by CMS, from an EHR data submission vendor pr oduct (as defined in paragraph (b) of this section) by the deadline specified by CMS for covered professional serv ices furnished by the eligible professional during the applicable reporting period. (v) Although an eligible pr ofessional may attempt to qualif y for the Physician Quality Reporting System incentive payment by repor ting on both individual Physician Quality Reporting System quality measures and measur es groups, using more than one reporting mechanism (as specified in paragraph (g)(2) of this section), or reporting for more than one reporting period, he or she will receive only one Physician Quality Reporting System incentive payment per TIN/NPI combination for a program year. (3) Reporting mechanisms for group practices . A group practice (as de fined in paragraph (b) of this section) who wishes to participate in the Physician Quality Reporting System must report information on Physician Quality Reporting System quality measures identified by CMS in one of the following manners: (i) Web interface . For 2013 and subsequent year s, reporting Physician Quality Reporting System quality measures to CMS usi ng a CMS web interface in the form and manner and by the deadline specified by CMS.1333 (ii) Registry . For 2013 and subsequent years, repo rting on Physician Quality Reporting System quality measures to a qualified registry (as specified in paragraph (b) of this section) in the form and manner and by the deadline specified by the qualified registry selected by the eligible professional. The sele cted registry must submit info rmation, as required by CMS, for covered professional services furnished by the eligible professional during the applicable reporting period to CMS on the eligible professional's behalf. (iii) Direct EHR product. For 2014 and subsequent years, reporting Physician Quality Reporting System quality measures to CMS by extr acting clinical data using a secure data submission method, as required by CMS, from a di rect EHR product (as defi ned in paragraph (b) of this section) by the deadlin e specified by CMS for covered pr ofessional services furnished by the eligible professional during th e applicable reporting period. (iv) EHR data submission vendor . For 2014 and subsequent years, reporting Physician Quality Reporting System quality measures to CMS by extracting clinical data using a secure data submission method, as required by CMS, fr om an EHR data submission vendor product (as defined in paragraph (b) of this section) by the deadline specif ied by CMS for covered professional services furnished by the eligible professional during the applicable reporting period. (v) Although a group practice may attempt to qualify for the Physician Quality Reporting System incentive payment by using more than one reporting mechanism (as specified in paragraph (g)(3) of this section), or reporti ng for more than one reporting period, the group practice will receive only one Physician Quality Reporting System incentive payment for a
program year. (h) Requirements for the payment adjustments . In order to satisfy the requirements for1334 the Physician Quality Reporting System payment adjustment for a particular program year, an individual eligible professional, as identified by a unique TIN/NPI combination (or in the case of a group practice under paragraph (i) of this section, by the group pract ice) must meet the criteria for satisfactory reporting specified by CMS for such year by reporting on either individual Physician Quality Reporting System measures or Physician Quality Reporting System measures groups identified by CMS during a reporting period sp ecified in paragraph (h )(1) of this section and using one of the reporting mechanisms specified in paragraph (h)(2) or (h )(3) of this section. (1) For purposes of this paragraph (h), th e reporting period for the payment adjustment, with respect to a payment adjustment year, is the 12-month period from January 1 through December 31 that falls 2 years prior to the year in which the payment adjustment is applied. (i) For the 2015 and 2016 PQRS payment ad justments only, an alternative 6-month reporting period, from July 1—December 31 that fa ll 2 years prior to th e year in which the payment adjustment is applied, is also available. (ii) [Reserved] (2) Reporting mechanisms for i ndividual eligible professionals . An individual eligible professional participating in the Physician Qual ity Reporting System must report information on Physician Quality Reporting System quality meas ures identified by CMS in one of the following

manners: (i) Claims . Reporting Physician Quality Reporting Sy stem quality measures or Physician Quality Reporting System measures groups to CM S, by no later than 2 months after the end of the applicable reporting period, on the eligible prof essional's Medicare Part B claims for covered professional services furnished during the applicable re porting period. (A) If an eligible professional re-submits a Medicare Part B claim for reprocessing, the1335 eligible professional may not att ach a G-code at that time for re porting on individual Physician Quality Reporting System measures or measures groups. (B) [Reserved] (ii) Registry . Reporting Physician Quality Reporti ng System quality measures or Physician Quality Reporting System measures groups to a qualified regist ry (as specified in paragraph (b) of this section) in the form and manner and by the d eadline specified by the qualified registry selected by the eligible prof essional. The selected registry must submit information, as required by CMS, for covered pr ofessional services furn ished by the eligible professional during the applicable reporting period to CMS on the el igible professional's behalf. (iii) Direct EHR product. Reporting Physician Quality Reporting System quality measures to CMS by extracting clinical data us ing a secure data submission method, as required by CMS, from a direct EHR product (as defined in paragraph (b) of this section) by the deadline specified by CMS for covered prof essional services furnished by th e eligible professional during the applicable re porting period. (iv) EHR data submission vendor . Reporting Physician Quality Reporting System quality measures to CMS by extracting clinical data us ing a secure data submission method, as required by CMS, from an EHR data submission vendor pr oduct (as defined in paragraph (b) of this section) by the deadline specified by CMS for covered professional serv ices furnished by the eligible professional during the applicable reporting period. (v) Administrative claims . For 2015, reporting data on Physician Quality Reporting System quality measures via administrative cl aims during the applic able reporting period. Eligible professionals that are administrativ e claims reporters must meet the following requirement for the payment adjustment:1336 (A) Elect to participate in the Physic ian Quality Reporting System using the administrative claims reporting option. (B) Reporting Medicare Part B claims data for CMS to determine whether the eligible professional has performed services applicable to certain individual P hysician Quality Reporting System quality measures. (3) Reporting mechanisms for group practices . A group practice (as de fined in paragraph (b) of this section) participating in the Physician Quality Reporting System must report information on Physician Quality Reporting System quality measures identified by CMS in one of the following manners: (i) Web interface . For the 2015 payment adjustment and subsequent payment adjustments, reporting Physician Quality Reporti ng System quality measures to CMS using a CMS web interface in the form and manner and by the deadline specified by CMS. (ii) Registry . For the 2015 subsequent adjustment and subsequent payment adjustments, reporting on Physician Quality Reporting System qua lity measures to a qualified registry (as specified in paragraph (b) of th is section) in the form and ma nner and by the deadline specified by the qualified registry selected by the eligible professional. The selected registry will submit information, as required by CMS, for covered pr ofessional services furn ished by the eligible professional during the applicable reporting period to CMS on the el igible professional's behalf. (iii) Direct EHR product. For the 2016 subsequent adjustment and subsequent payment adjustments, reporting Physician Quality Re porting System quality measures to CMS by extracting clinical data using a secure data submission method, as required by CMS, from a direct EHR product (as defined in paragraph (b) of this secti on) by the deadline specified by1337 CMS for covered professional services furnis hed by the eligible pr ofessional during the applicable reporting period. (iv) EHR data submission vendor . For the 2016 subsequent adjustment and subsequent payment adjustments , r eporting Physician Quality Reporting System quality measures to CMS by extracting clinical data using a secure data submission method, as required by CMS, from an EHR data submission vendor product (as defined in pa ragraph (b) of this section) by the deadline specified by CMS for covered professional servic es furnished by the group practice during the applicable reporting period. (v) Administrative claims . For 2015, reporting data on Physician Quality Reporting System quality measures via administrative clai ms during the applicable reporting period. Group practices that are administrative claims reporters must meet th e following requirement for the payment adjustment: (A) Elect to participate in the Physic ian Quality Reporting System using the administrative claims reporting option. (B) Reporting Medicare Part B claims data for CMS to determine whether the group practice has performed services applicable to certain individual Physician Quality Reporting System quality measures. (i) Requirements for group practices

. Under the Physician Quality Reporting System, a group practice (as defined in paragraph (b) of th is section) must meet all of the following requirements: (1) Meet the participation requirements specified by CMS for the Physician Quality Reporting System group practice reporting option. (2) Report measures in the form and manner specified by CMS.1338 (3) Meet other requirements for sa tisfactory reporting specified by CMS. (4) Meet other requirements for sa tisfactory reporting specified by CMS. (5) Meet participation requirements. (i) If an eligible professional, as identif ied by an individual NPI, has reassigned his or her Medicare billing rights to a gr oup practice (as identified by the TI N) selected to participate in the Physician Quality Reporting System group pract ice reporting option for a program year, then for that program year the eligible professional must participate in the Physician Quality Reporting System via the group practice reporting option. (ii) If, for the program year, the eligible prof essional participates in the Physician Quality Reporting System as part of a group practice (as id entified by the TIN) that is not selected to participate in the Physician Quality Reporting System group practice reporting option for that program year, then the eligible professional may individually participate and qualify for a Physician Quality Reporting System incentive by meeting the requirements specified in paragraph (g) of this section under that TIN. (j) Informal review
. Eligible professionals (or in the case of reporting under paragraph (g) of this section, group practices) may seek an informal review of the determination that an eligible professional (or in the case of reporting under para graph (g) of this section, group practices) did not satisfactorily submit data on quality measur es under the Physician Quality Reporting System. (1) To request an informal review for the PQRS incentives, an eligible professional (or in the case of reporting under paragraph (g) of this section, group practices ) must submit a request to CMS via the Web within 90 days of the release of the feedback reports. The request must be submitted in writing or via e-mail and summarize the concern(s) and reasons for requesting an informal review and may also include information to assist in the review.1339 (i) CMS will provide a written response within 90 days of the rece ipt of the original request. (ii) All decisions based on the informal review will be final. (iii) There will be no further review or appeal. (2) To request an informal review for the PQRS payment adjustments, an eligible professional or group practices must submit a reque st to CMS via the Web by February 28 of the year in which the eligible prof essional is receiving the applic able payment adjustment. The request must be submitted in writing and summari ze the concern(s) and reasons for requesting an informal review and may also include information to assist in the review. (i) CMS will provide a timely, written response after the receipt of the original request. (ii) All decisions based on the informal review will be final. (iii) There will be no further review or appeal.
* * * * * 19. Section 414.92 is amended by -- A. Revising paragr aphs (c)(2)(ii)(A)(5 ) and (c)(2)(ii)(A)(6 ). B. Adding paragraph (f)(2)(i)(A) and addi ng and reserving para graph (f)(2)(i)(B). C. Redesignating paragraph (g) as paragr aph (h), and adding new paragraph (g). The revision and addition reads as follows: § 414.92 Electronic Prescribing Incentive Program. * * * * * (c) * * * (2) * * * (ii) * * *1340 (A) * * * (5 ) Eligible professionals who achieve mean ingful use during the respective 6 or 12- month payment adjustment reporting periods. (6 ) Eligible professionals who have regist ered to participate in the EHR Incentive Program and adopted Certified EHR Technology prio r to application of the respective payment adjustment.
* * * * * (f) * * * (2) * * * (i) * * * (A) If an eligible professional re-submits a Medicare Part B claim for reprocessing, the eligible professional may not attach a G-code at that time for reporting on the electronic prescribing measure. (B) [Reserved]
* * * * * (g) Informal review

. Eligible professionals (or in th e case of reporting under paragraph (e) of this section, group practices ) may seek an informal review of the determination that an eligible professional (or in th e case of reporting under paragr aph (e) of this section, group practices) did not meet the requirements fo r the 2012 and 2013 incentives or the 2013 and 2014 payment adjustments. (1) To request an informal review fo r the 2012 and 2013 incentives, an eligible professional or group practice must submit a request to CMS via email within 90 days of the release of the feedback reports. The request mu st be submitted in writing and summarize the1341 concern(s) and reasons for requesting an informal review and may also include information to assist in the review. (2) To request an informal review for the 2013 and 2014 payment adjustments, an eligible professional or group pr actices must submit a request to CMS via email by February 28 of the year in which the eligible professional is receiving the applicable payment adjustment. The request must be submitted in writing a nd summarize the concern(s) and reasons for requesting an informal review and may also in clude information to assist in the review. (3) CMS will provide a written response of CMS’ determination. (i) All decisions based on the informal review will be final. (ii) There will be no further review or appeal.
* * * * * 20. Section 414.610 is amended by revising paragr aphs (c)(1)(ii), (c)( 5)(ii), and (h) to read as follows: §414.610 Basis of payment. * * * * * (c) * * * (1) * * * (ii) For services furnished during the period July 1, 2008 through December 31, 2012, ambulance services originating in--- (A) Urban areas (both base rate and mileage) are paid based on a rate that is 2 percent higher than otherwise is applic able under this section; and (B) Rural areas (both base rate and mileage) are paid based on a rate that is 3 percent higher than otherwise is app licable under this section.1342

* * * * * (5) * * * (ii) For services furnished during the period July 1, 2004 through December 31, 2012, the payment amount for the ground ambulance base rate is increased by 22.6 percent where the point of pickup is in a rural area determined to be in the lowest 25 per cent of rura l population arrayed by population density. The amount of this increase is based on CMS's estimate of the ratio of the average cost per trip for the rural areas in the lowe st quartile of population compared to the average cost per trip for the rural areas in the highest qu artile of population. In making this estimate, CMS may use data provided by the GAO.
* * * * * (h) Treatment of certain areas fo r payment for air ambulance services

. Any area that was designated as a rural area for purposes of ma king payments under the ambulance fee schedule for air ambulance services furnished on December 3 1, 2006, must be treated as a rural area for purposes of making payments under the ambulan ce fee schedule for ai r ambulance services furnished during the period July 1, 2008 through December 31, 2012. 21. Section 414.904 is amended by revising pa ragraphs (d)(3)(ii) , (d)(3)(iii), and (d)(3)(iv) to read as follows: §414.904 Average sales price as the basis for payment. * * * * * (d) * * * (3) * * * (ii) Payment at 103 percent of the average ma nufacturer price for a billing code will be applied at such times when all of the following criteria are met:1343 (A) The threshold for making price substitutions , as defined in paragraph (d)(3)(iii) of this section is met. (B) 103 percent of the average manufacturer price is less than the 106 percent of the average sales price for the quarter in which the substitution would be applied. (C) Beginning in 2013, the drug and dosage form described by the HCPCS code is not identified by the FDA to be in short supply at the time that ASP calcu lations are finalized. (iii) The applicable percentage threshold for average manufact urer price comparisons is 5 percent and is reached when-- (A) The average sales price for the billing c ode has exceeded the average manufacturer price for the billing code by 5 percent or more in 2 consecutive quarters, or 3 of the previous 4 quarters immediately preceding the qua rter to which the price substitution would be applied; and (B) The average manufacturer price for the bill ing code is calculated using the same set of National Drug Codes used for the aver age sales price for the billing code. (iv) The applicable percentage threshold for widely availabl e market price comparisons is 5 percent. * * * * * 22. Subpart N is added to Pa rt 414 to read as follows: Subpart N--Value-Based Payment Modifi er under the Physician Fee Schedule
Sec. 414.1200 Basis and scope. 414.1205 Definitions. 414.1210 Application of the value-based payment modifier. 414.1215 Performance and payment adjustment peri ods for the value-based payment modifier.1344 414.1220 Reporting mechanisms for the value-based payment modifier. 414.1225 Alignment of Physician Quality Repor ting System (PQRS) quality measures and quality measures for the value-based payment modifier. 414.1230 Additional measures for groups of physicians.
414.1235 Cost measures. 414.1240 Attribution for quality of care and cost measures. 414.1245 Scoring methods for the value-based payment modifier using the quality-tiering approach. 414.1250 Benchmarks for quality of care measures. 414.1255 Benchmarks for cost measures. 414.1260 Composite scores. 414.1265 Reliability of measures. 414.1270 Determination and calculation of Value- Based Payment Modifier adjustments. 414.1275 Value-based payment modifier quality-tiering sc oring methodology. 414.1280 Limitation on review. 414.1285 Informal inquiry process. Subpart N--Value-Based Payment Modifi er under the Physician Fee Schedule § 414.1200 Basis and scope. (a) Basis

. This subpart implements section 1848(p) of the Act by establishing a payment modifier that provides for diffe rential payment starting in 201 5 to a group of physicians under the Medicare physician fee schedule based on the quality of care furnished compared to cost during a performance period. (b) Scope

. This subpart sets forth the following:1345 (1) The application of the va lue-based payment modifier. (2) Performance and payment adjustment periods. (3) Reporting mechanisms for the value-based payment modifier. (4) Alignment of PQRS quality of care m easures with the quality measures for the value-based payment modifier. (5) Additional measures for groups of physicians. (6) Cost measures. (7) Attribution for quality of care and cost measures. (8) Scoring methods for the va lue-based payment modifier. (9) Benchmarks for quality of care measures. (10) Benchmarks for cost measures. (11) Composite scores. (12) Reliability of measures. (13) Payment adjustments. (14) Value-based payment modifier quality-tiering scoring methodology. (15) Limitation of review. (16) Inquiry process. § 414.1205 Definitions. As used in this subpart, unless otherwise indicated— Accountable care organization (ACO) has the same mean ing given this term under §425.20 of this chapter. Critical access hospital has the same meaning given this term under §400.202 of this chapter.1346

Electronic health record (EHR) has the same meaning given this term under §414.92 of this chapter. Eligible professional has the same meaning given this term under section 1848(k)(3)(B) of the Act. Federally Qualified Health Center has the same meaning given this term under §405.2401(b) of this chapter. Group of physicians means a single Tax Identification Number (TIN) with 2 or more eligible professionals, as identified by their individual National Provider Identifier (NPI), who have reassigned their Medicar e billing rights to the TIN. Performance period means the calendar year that will be used to assess the quality of care furnished compared to cost. Performance rate mean the calculated rate for each quality or cost measure such as the percent of times that a part icular clinical quality action wa s reported as being performed, or a particular outcome was attained, for the app licable persons to whom a measure applies as described in the denominator for the measure. Physician has the same meaning given this term under section 1861(r) of the Act. Physician Fee Schedule has the same meaning given th is term under part 410 of this chapter. Physician Quality Reporting System means the system established under section 1848(k) of the Act. Risk score means the beneficiary risk score derived from the CMS Hierarchical Condition Categories (HCC) model.1347 Taxpayer Identification Number (TIN) has the same meaning given this term under §425.20 of this chapter. Value-based payment modifier means the percentage as determined under §414.1270 by which amounts paid to a physician or group of physicians under the Medicare physician fee schedule established under secti on 1848 of the Act are adjusted based upon a comparison of the quality of care furnished to cost as determined by this subpart. § 414.1210 Application of the value-based payment modifier. (a) The value-based payment modifier is applicable to physicians: (1) For CY 2015, in groups with 100 or mo re eligible professionals based on the performance period described at § 414.1215(a). (2) [Reserved] (b) Exceptions . (1) Groups of physicians that are participating in the Medicare Shared Savings Program, the testing of the Pioneer AC O model, or other sim ilar Innovation Center or CMS initiatives shall not be subject to any ad justments under the value-based payment modifier for CY 2015 and CY 2016. (2) [Reserved] (c) Group size determination. Identification of the groups of physicians subject to the value-based payment modifier is based on a query of PECOS on October 15, 2013. Groups of physicians are removed from this October 15 list if, based on a claims analysis, the group of physicians did not have 100 or more eligible professionals that submitted claims during the performance period. § 414.1215 Performance and payment adjustment periods for the value-based payment
modifier.1348 (a) The performance period is calendar ye ar 2013 for value-based payment modifier adjustments made in the calendar ye ar 2015 payment adjustment period. (b) The performance period is calendar ye ar 2014 for value-based payment modifier adjustments made in the calendar year 2016 payment adjustment period. § 414.1220 Reporting mechanisms for the value-based payment modifier. Groups of physicians subject to the value-based payment modifier may submit data on quality measures as specified under the Physic ian Quality Reporting System and in § 414.90(g) for which they are eligible and §414.90( h)(3)(vi) administrative claims. § 414.1225 Alignment of Physician Quality Re porting System quality measures and quality measures for the value-based payment modifier. All of the quality measures for which groups of physicians are elig ible to report under the Physician Quality Reporting System starting in CY 2013 are used to calculate the valuebased payment modifier program to the extent the group of physicians submits data on such

measures. § 414.1230 Additional measures fo r groups of physicians. The value-based payment modifier includes the following additional quality measures for all groups of physicians subject to the value-based payment modifier: (a) A composite of rates of potentially preventable hospital admissions for heart failure, chronic obstructive pulmonary disease, and di abetes. The rate of potentially preventable hospital admissions for diabetes is a composite measure of uncontrolled diabetes, short term diabetes complications, long term diabetes co mplications and lower extremity amputation for diabetes. (b) A composite of rates of potentially preventable hospital admissions for dehydration,1349 urinary tract infections, and bacterial pneumonia. (c) Rates of an all-cause hos pital readmissions measure. § 414.1235 Cost measures. Costs for groups of physicians subject to th e value-based payment modifier are assessed based on the following 6 cost measures: (a) Total per capita costs for all attributed beneficiaries; and (b) Total per capita costs for all attributed be neficiaries with diabetes, coronary artery disease, chronic obstructive pulmon ary disease, or heart failure. (c) Total per capita costs include all fee-for-s ervice payments made under Medicare Part A and Part B. (1) Payments under Medicare Part A and Part B will be adjusted using CMS’ payment standardization methodology to ensure fair comparisons across geographic areas. (2) The CMS-HCC model (and adjustments fo r ESRD status) is used to adjust standardized payments for each cost measure; that is-- (i) Total per capita costs; and (ii) Total per capita costs for beneficiaries with the following conditions: coronary artery disease, COPD, diabetes, and heart failure. § 414.1240 Attribution for quality of care and cost measures. Beneficiaries are attributed to groups of phys icians subject to the value-based payment modifier using a method generally consistent with the method of assignment of beneficiaries under § 425.402 of this chapter. § 414.1245 Scoring methods for the value-bas ed payment modifier using the qualitytiering approach.1350 For each quality of care and cost measure, a standardized score is calculated for each group of physicians subject to the valu e-based payment modifier by dividing-- (a) The difference between their performance rate and the benchmark, by (b) The measure’s standard deviation. § 414.1250 Benchmarks for quality of care measures. (a) The benchmark for quality of care meas ures reported through the PQRS using the claims, registries, EHR, or web interface is th e national mean for that measure’s performance rate (regardless of the reporting mechanism) during the year prior to the performance period. In calculating the national benchmar k, individuals’ and groups of physicians’ performance rates are weighted by the number of beneficiaries us ed to calculate the i ndividuals’ or group of physician’s performance rate. (b) The benchmark for each quality of car e measure reported through the PQRS using the administrative claims option is the national mean for that measure’s performance rate during the year prior to the performance period. § 414.1255 Benchmarks for cost measures. The benchmark for each cost measure is the national mean of the performance rates calculated among all groups of physicians for which beneficiar ies are attributed to the group of physicians and are subject to the value-based pa yment modifier. In calculating the national benchmark, groups of physicians’ performance rates are weighted by the number of beneficiaries used to calculate the gr oup of physician’s performance rate. § 414.1260 Composite scores. (a)(1) The standardized score for each quality of care measure is classified into one of the following equally weighted domains to determine the quality composite:1351 (i) Patient safety. (ii) Patient experience. (iii) Care coordination. (iv) Clinical care. (v) Population/community health. (vi) Efficiency. (2) If a domain includes no measure or does not reach the minimum case size in § 414.1265, the remaining domains are equally weighted to form the quality of care composite. (b)(1) The standardized score for each cost measure is grouped into two separate and equally weighted domains to determine the cost composite: (i) Total per capita costs for all attribut ed beneficiaries (one measures); and (ii) Total per capita costs for all attribut ed beneficiaries with specific conditions: diabetes, coronary artery diseas e, chronic obstructive pulmonary di sease, or heart failure (four measures). (2) Measures within each domain are equally weighted. § 414.1265 Reliability of measures. To calculate a composite score for a quality or cost measure based on claims, a group of physicians subject to the value- based payment modifier must ha ve 20 or more cases for that

measure. (a) In a performance period, if a group of physicians has fewer than 20 cases for a measure, that measure is excluded from its dom ain and the remaining measures in the domain are given equal weight. (b) In a performance period, if a reliable qua lity of care composite or cost composite1352 cannot be calculated, payments shall not be adjust ed under the value-based payment modifier. § 414.1270 Determination and calculation of Va lue-Based Payment Modifier adjustments. (a) Downward payment adjustments . A downward payment adjustment will be applied to a group of physicians subject to th e value-based payment modifier if: (1) Such group does neither self-nominates fo r the PQRS GPRO and reports at least one measure nor elects the PQRS administrativ e claims option for CY 2013 as defined in §414.90(h); (i) Such adjustment will be -1.0 percent. (ii) [Reserved] (2) Such group elects that its value-base d payment modifier be calculated using a quality-tiering approach, and is determined to have poor performance (low quality and high costs), (i) Such adjustment will not exceed -1.0 percent as specified in § 414.1275. (ii) [Reserved] (b) No payment adjustments . There will be no value-based payment modifier adjustment applied to a group of physicians subjec t to the value-based payment modifier if such group either (1) Self-nominates for the PQRS GPRO and reports at least one measure; or (2) Elects the PQRS admini strative claims option for CY 2013 as defined in §414.90(h). (c) Upward payment adjustments . If a group of physicians subject to the value-based payment modifier elects that the value-based pa yment modifier be calc ulated using a qualitytiering approach, upward payment adjustments are determined based on the projected aggregate amount of downward payment adjustments determined under paragraph (a) of this section and1353 applied as specified in §414.1275. § 414.1275 Value-based payment modifier quality-tiering scoring methodology. (a) The value-based payment modifier amount for a group of physicians subject to the value-based payment modifier that elects the quality-tiering approach is based upon a comparison of the composite of quality of care m easures and a composite of cost measures. (b) Quality composite and cost composite ar e classified into hi gh, average, and low categories based on whether the composites are stat istically above, not different from, or below the mean composite scores. (1) Quality composites that are one or more standard deviations above the mean are classified into the high category. Quality compos ites that are one or more standard deviations below the mean are classified into the low category. (2) Cost composites that are one or more standard devi ations below the mean are classified into the low category. Cost composite s that are one or more standard deviations above the mean are classifi ed into the high category. (c) The following value-based paymen t modifier percents apply: Value-Based Payment Modifier Amounts for Groups of Physicians Requesting the Quality-Tiering Approach Quality/cost Low cost Average cost High cost High quality +2.0x 1 +1.0x 1 +0.0% Average quality +1.0x 1 +0.0% -0.5% Low quality +0.0% -0.5% -1.0% 1 Groups of physicians eligible for an additiona l +1.0x if reporting Physician Quality Reporting System quality measures through the GPRO using th e web interface, claims, registries, or EHRs, and average beneficiary risk score in the top 25 percent of all beneficiary risk scores. (d) Groups of physicians subject to the valu e-based payment modifier that have an attributed beneficiary population with an average risk score in the top 25 percent of the risk scores of beneficiaries nationw ide and elect the quality-tieri ng approach, receive a greater upward payment adjustment as follows:1354 (1) Classified as high quality/low cost receiv e an upward adjustment of +3x (rather than +2x); and (2) Classified as either high quality/average cost or average quality/low cost receive an upward adjustment of +2 x (rather than +1x). § 414.1280 Limitation on review. (a) There shall be no administ rative or judicial review under section 1869 of the Act, section 1878 of the Act, or otherwise of all of the following: (1) The establishment of the value-based payment modifier. (2) The evaluation of the quality of care composite, including th e establishment of appropriate measure of the quality of care. (3) The evaluation of costs composite, includ ing establishment of appropriate measures of costs. (4) The dates of implementation of the value-based payment modifier. (5) The specification of the initial perform ance period and any other performance period. (6) The application of the va lue-based payment modifier. (7) The determination of costs. (b) [Reserved.] § 414.1285 Informal inquiry process.1355 After the dissemination of the annual Physic ian Feedback reports, a group of physicians may contact CMS to inquire about its report a nd the calculation of th e value-based payment modifier.
PART 415--SERVICES FURNISHED BY PHYSICIANS IN PROVIDERS,
SUPERVISING PHYSICIANS IN TEACH ING SETTINGS, AND RESIDENTS IN
CERTAIN SETTINGS 23. The authority citation for part 415 continues to read as follows: Authority : Secs. 1102 and 1871 of the Social Security Act (42 U.S.C. 1302 and 1395hh). §415.130 [Amended] 24. In §415.130(d)(1) and (d)(2), remove th e reference to “December 31, 2011” and add in its place the reference to “June 30, 2012.”
PART 421--MEDICARE CONTRACTING 25. The authority citation for part 421 continues to read as follows: Authority : Sec. 1102 and 1871 of the Social Se curity Act (42 U.S.C. 1302 and 1395hh). Subpart F--[REMOVED AND RESERVED] 26. Subpart F is removed and reserved.
PART 423--VOLUNTARY MEDICARE PRESCRIPTION DRUG BENEFIT 27. The authority citation for part 42 3 continues to read as follows: Authority : Sections 1102, 1106, 1860D-1 throu gh 1860D-42, and 1871 of the Social Security Act (42 U.S.C. 1302, 1306, 1395w-101 through 1395w-152, and 1395hh). 28. Section 423.160 is amended by-- A. Revising paragraphs (a)(3)( iv), (b)(1)(i), and (b)(1)(ii).1356 B. Adding paragraphs (b )(1)(iii) and (b)(2)(iii). The revisions and additions read as follows: §423.160 Standards for electronic prescribing. (a) * * * (3) * * * (iv) Until November 1, 2014, entities transmitt ing prescriptions or prescription-related information where the prescriber is required by law to issue a pr escription for a patient to a nonprescribing provider (such as a nursing facility) that in turn forwards the prescription to a dispenser are exempt from the requirement to use the NCPDP SCRIPT Standard adopted by this section in transmitting such prescriptions or pres cription-related information. As of November 1, 2014, such entities will be required to use th e adopted NCPCP SCRIPT standard(s).
* * * * * (b) * * * (1) * * * (i) Before April 1, 2009 the standards specifi ed in paragraphs (b)(2)(i), (b)(3), (b)(4), (b)(5), and (b)(6) of this section. (ii) From April 1, 2009 until January 14, 2013, th e standards specified in paragraphs (b)(2)(ii), (b)(3)-(b)(4), (b)(5) and (b)(6) of this section. (iii) From January 15, 2013 until October 31, 2013 the standards specified in paragraphs (b)(2)(ii), (b)(3)-(b)(4), (b)(5) and (b)(6) of this section.
* * * * * (2) * * * (iii) The National Council for Prescrip tion Drug Programs SCRIPT standard,1357 Implementation Guide Version 10.6 approved Nove mber 12, 2008 (incorporated by reference in paragraph (c)(1)(v) of this secti on), to provide for the communicat ion of a prescription or related prescription related information between pres cribers and dispensers for the following: (A) Get message transaction. (B) Status response transaction. (C) Error res ponse transaction. (D) New prescription transaction. (E) Prescription change request transaction. (F) Prescription change response transaction. (G) Refill prescription request transaction. (H) Refill prescription response transaction. (I) Verification transaction. (J) Password change transaction. (K) Cancel prescripti on request transaction. (L) Cancel prescription response transaction. (M) Fill status notification.
* * * * *
PART 425--MEDICARE SHARED SAVINGS PROGRAM 29. The authority citation for part 425 continues to read as follows: Authority : Secs. 1102, 1106, 1871, and 1899 of the Social Security Act (42 U.S.C. 1302 and 1395hh). 30. Section 425.308 is amended by revising pa ragraph (e) to read as follows: §425.308 Public reporting and transparency

. * * * * *1358 (e) Results of claims based measures . Quality measures reported using the GPRO web interface and patient experience of care survey measures will be reported on Physician Compare in the same way as for the group practices th at report under the Physician Quality Reporting System. 31. Section 425.504 is amended by adding paragraph (b) to read as follows: §425.504 Incorporating reporting requirements rel ated to the Physician Quality Reporting System. * * * * * (b) Physician Quality Reporting System payment adjustment . (1) ACOs, on behalf of their ACO provider/suppliers who are eligible professionals, must submit one of the measures determined under §425.500 using the GPRO web inte rface established by CMS, to satisfactorily report on behalf of their elig ible professionals for purposes of the 2015 Physician Quality Reporting System payment adjustment under the Shared Savings Program. (2)(i) ACO providers/suppliers that are elig ible professionals with in an ACO may only participate under their ACO participant TIN as a group practice under the Physician Quality Reporting System Group Practice Reporting Option of the Shared Savings Program for purposes of the 2015 Physician Quality Reporting System payment adjustment under the Shared Savings Program. (ii) Under the Shared Savings Progr am, an ACO, on behalf of its ACO providers/suppliers who are eligib le professionals, must satisfactor ily report one of the measures determined under Subpart F of this part during the reporting period for a year, as defined in paragraph (b)(6) of this section, according to the method of submission established by CMS under the Shared Savings Program for purposes of the 2015 Physician Quality Reporting System1359 payment adjustment. (3) If an ACO, on behalf of its ACO provide rs/suppliers who are e ligible professionals, does not satisfactorily report for purposes of a 2015 Physician Quality Reporting System payment adjustment, each ACO supplier/provider w ho is an eligible prof essional, will receive a payment adjustment, as described in paragraph (b)(5) of this section. (4) ACO participant TINs and individual AC O providers/suppliers who are eligible professionals cannot satisfactorily report for purposes of a 2015 Physician Quality Reporting System payment adjustment outside of the Medicare Shared Savings Program. (5) For eligible professionals subject to the 2015 Physic ian Quality Reporting System payment adjustment under the Medicare Shared Savings Program, the Medicare Part B Physician Fee Schedule amount for covered professional serv ices furnished during the program year is equal to the applicable percen t of the Medicare Part B Physician Fee Schedule amount that would otherwise apply to such serv ices under section 1848 of the Act. (i) The applicable percen t for 2015 is 98.5 percent. (ii) The applicable percent for 2016 and subsequent years is 98.0 percent. (6) The reporting period for a year is the calendar year from January 1 through December 31 that occurs 2 years prior to the pr ogram year in which the payment adjustment is applied.
PART 486--CONDITIONS FOR COVERAGE OF SPECIALIZED SERVICES
FURNISHED BY SUPPLIERS 32. The authority citation for part 486 continues to read as follows: Authority: Secs. 1102, 1138, and 1871 of the Social Security Act (42 U.S.C. 1302, 1320b-8, and 1395hh) and section 371 of the Public Health Se rvice Act (42 U.S.C 273).1360 33. Section 486.106 is amended by revising the in troductory text and paragraphs (a) and (b) to read as follows: §486.106 Condition for coverage: Referral for service and preservation of records. All portable X-ray services performed for Medicare bene ficiaries are ordered by a physician or a nonphysician practitioner as provid ed in §410.32(a) of this chapter or by a nonphysician practitioner as provided in §410.32( a)(2) and records are properly preserved. (a) Standard—referral by a physicia n or nonphysician practitioners. Portable X-ray examinations are performed only on the order of a physician licensed to pr actice in the State or by a nonphysician practitioner acting within th e scope of State law. Such nonphysician practitioners may be trea ted the same as physicians treating be neficiaries for the purpose of this paragraph. The supplier’ s records show that: (1) The portable X-ray test was ordere d by a licensed physician or a nonphysician practitioner acting within th e State scope of law; and (2) Such physician or nonphysician practit ioner’s written, signed order specifies the reason a portable X-ray test is required, the area of the body to be exposed, the number of radiographs to be obtained, and the views need ed; it also includes a statement concerning the condition of the patient which indicates w hy portable X-ray serv ices are necessary. (b) Standard—records of examinations performed. The supplier makes for each patient a record of the date of the portable X-ray examination, the name of the patient, a description of the procedures ordered and performed, the referring physician or nonphysician practitioner, the operator(s) of the portable X-ray equipment who performed th e examination, the physician to whom the radiograph was sent, and the date it was sent.
* * * * *1361

PART 495--STANDARDS FOR THE ELECTRONIC HEALTH RECORD
TECHNOLOGY INCENTIVE PROGRAM 34. The authority citation for part 495 continues to read as follows: Authority : Secs. 1102 and 1871 of the Social Security Act (42 U.S.C. 1302 and 1395hh). 35. Section 495.8 is amended by revising pa ragraph (a)(2)(v) to read as follows: § 495.8 Demonstration of meaningful use criteria. (a) * * * (2) * * * (v) Exception for Medicare EPs for 2012 and 2013—Participation in the Physician Quality Reporting System-Medicare EHR Incentive Pilot

. To satisfy the clinical quality measure reporting requirements of meaningful use, aside from attestation, an EP participating in the Physician Quality Reporting System may also pa rticipate in the Physician Quality Reporting System-Medicare EHR Incentive Pilot through one of the following methods: (A) Submission of data extracted from th e EP’s certified EHR technology through a Physician Quality Reporting System qualified EHR data submission vendor; or (B) Submission of data extracted from the EP’s certified EHR technology, which must also be through a Physician Qualit y Reporting System qualified EHR.
* * * * *CMS-1590-P
Authority: (Catalog of Federal Domestic Assi stance Program No. 93.773, Medicare-- Hospital Insurance; and Program No. 93.774, Me dicare--Supplementary Medical Insurance Program)

Dated: October 24, 2012.

______________________ Marilyn Tavenner, Acting Administrator, Centers for Medicare & Medicaid Services

Approved: October 25, 2012.

_____________________ Kathleen Sebelius, Secretary.

BILLING CODE 4120-01-P

[FR Doc. 2012-26900 Filed 11/01/2012 at 4:15 pm; Publication Date: 11/16/2012]