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-P]

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: Proposed rule.

SUMMARY: This major proposed rule addresses ch anges to the physician fee schedule, payments for Part B drugs, and other Medicare Part B payment policie s to ensure that our payment systems are updated to reflect changes in medical practice and the relative value of services. It would also impleme nt provisions of the Affordable Care Act by establishing a faceto-face encounter as a condition of payment for cer tain durable medical equipment (DME) items. In addition, it would implement statutory chan ges regarding the termination of non-random prepayment review under the Medicare Prescr iption Drug, Improvement, and Modernization Act of 2003. Finally, this proposed rule also incl udes a discussion regarding the Chiropractic Services Demonstration program.

DATES : Comment date : To be assured consideration, commen ts must be received at one of the addresses provided below, no later than 5 p.m. on [ O F R

— i n s e r t d a t e 6 0 d a y s a f t e r t h e d a t e o f

f i l i n g f o r p u b l i c i n s p e c t i o n a t O F R

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ADDRESSES: In commenting, please refer to file code CMS-1590-P. Because of staff and resource limitations, we ca nnot accept comments by facsimile (FAX) transmission.CMS-1590-P 2

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 http://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-P, 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-P, Mail Stop C4-26-05, 7500 Security Boulevard, Baltimore, MD 21244-1850. 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--CMS-1590-P 3

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: Corinne Axelrod, (410) 786-5620, for any physician payment issue not id entified below. Ryan Howe, (410) 786-3355, for issues re lated to practice expense methodology and direct practice expense inputs, telehealth servi ces, and issues related to primary care and care

coordination.CMS-1590-P 4

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. Ken Marsalek, (410) 786-4502, for issues re lated to the multiple procedure payment reduction and payment for the technical component of pathology services. Michael Moore, (410) 786-6830, fo r issues related to geographi c practice cost indices and the sustainable growth rate. Pam West, (410) 786-2302, for issues related to therapy services. Chava Sheffield, (410) 786-2298, for issues related to certified registered nurse

anesthetists. 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. 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 rela ted to the Physician Feedback Reporting Program and Value-Based Payment Modifier.CMS-1590-P 5

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: 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: http://www.regulations.gov . Follow the search instructions on that Website to view public comments. 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 I. Executive Summary and Background II. Provisions of the Proposed Rule 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 ScheduleCMS-1590-P 6

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 Anesthetis ts and Chronic Pain Management Services L. Ordering of Portable X-Ray Services III. Other Provisions of the Proposed Regulation

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 H. Electronic Prescribing (eRx) Incentive Program 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 VaccineCMS-1590-P 7

M. Updating Existing Standards for E-prescr ibing under Medicare Part D and Lifting the LTC Exemption

IV. Technical Corrections A. Waiver of Deductible for Surgical Servi ces Furnished on the Same Date as a Planned Screening Colorectal Cancer Test and Colo rectal Cancer Screening Test Definition V. Collection of Information Requirements VI. Response to Comments VII. Regulatory Impact Analysis Acronyms Because of the many organizations and term s to which we refer by acronym in this proposed rule, we are listing these acronyms and their 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 hospital

CBSA Core-Based Statistical AreaCMS-1590-P 8

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 2011 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 EMTALA Emergency Medical Treatment and Ac tive Labor Act (part of the Consolidated Omnibus Budget Reconciliati on Act of 1985 (Pub. L. 99-272) eRx Electronic prescribing

FFS Fee-for-service

FR Federal Register GAF Geographic adjustment factor GAO [U.S.] Government Accountability OfficeCMS-1590-P 9

GPRO Group Practice Reporting Option 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 (MCAC)) 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)CMS-1590-P 10

MIPPA Medicare Improvements for Patients and Providers Act of 2008 (Pub. L. 110-275) 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) MP Malpractice 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. 111-286CMS-1590-P 11

PVBP Physician and Other Health Prof essional Value-Based Purchasing Workgroup RAC [Medicare] Recovery Audit Contractor 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 proposed rule, 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 through the In ternet. The PFS Addenda along with other supporting documents and tables referenced in this proposed rule with comment period are available through the Intern et on the CMS Website at http://www.cms.gov/PhysicianFeeSched/

. Click on the link on the left side of the screen titled, ‘‘PFS Federal Regu lations Notices’’ for a chronological list of PFS Federal Register and other related documents. For the CY 2013 PFS proposed rule with comment period, refer to item CMS–1590–P. Readers who experience any problems accessing any of the Addenda or other docum ents referenced in this proposed rule withCMS-1590-P 12

comment period and posted on the CMS Website identified above should contact Corinne Axelrod at (410) 786–5620. CPT (Current Procedural Terminology) Copyright Notice Throughout this proposed rule, we use CPT codes and descriptions to re fer to a variety of

services. We note that CPT codes and desc riptions are copyright 2011 American Medical Association. All Rights Reserv ed. CPT is a registered trademark of the American Medical Association (AMA). A pplicable Federal Acquisition Regul ations (FAR) and Defense Federal Acquisition Regulatio ns (DFAR) apply. I. Executive Summary and Background A. Executive Summary 1. Purpose This major proposed rule would revise payment polices under the Medicare Physician Fee Schedule (PFS) and make other policy changes related to Medicare Part B payment. These changes would be applicable to services fu rnished in CY 2013. It also would implement provisions of the Affordable Care Act by estab lishing a face-to-face encounter as a condition of payment for certain durable medical equipment (DME) items. In addition, it would implement 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 (MP) expense. In this major proposed rule, we propose payment rates for CY 2013 for the PFS, payments for Part B drugs, and other Medicare Part B payment policies to ensure that our payment systems ar e updated to reflect changes in medical practice

and the relative value of services . It also proposes to implemen t provisions of the AffordableCMS-1590-P 13

Care Act by establishing a face-to-face encounter as a condition of payment for certain durable medical equipment (DME) items, and by removing cer tain regulations regarding the termination of non-random prepayment review . It also proposes new cl aims-based data reporting requirements for therapy services to implement a provision in the Middle Class Tax Relief and Jobs Creation Act (MCTRCA). In addition, this rule proposes:

● Potentially Misvalued Codes to be Evaluated.

● Additional Multiple Procedure Payment Reductions (MPPR).

● Expanding Medicare Telehealth Services.

● Regulatory Changes regarding Payment for Technical Component of Certain Physician Pathology Services to Conform to Statute.

● Primary Care and Care Coordination Service.

● Payment rates for Newly Covered Preventive Services.

● Definition of Anesthesia and Related Ca re in the Certified Registered Nurse

Anesthetists Benefit.

● Ordering Requirements for Portable X-ray Services.

● Updates to the Ambulance Fee Schedule.

● Part B Drug Payment Rates.

● Ambulance Coverage-Physician Certification Statement.

● Updating the-- ++ Physician Compare Website. ++ Physician Quality Reporting System. ++ Electronic Prescribing (eRx) Incentive Program. ++ Medicare Shared Savings Program.

● Providing Budget Neutrality Discu ssion on the Chiropractic Demonstration.CMS-1590-P 14

● Physician Value-Based Payment Modifi er and the Physician Feedback Reporting Program.

● Medicare Coverage of Hepatitis B Vaccine.

● Updating 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 PFS 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 proposed changes would affect the specialty distribution of Medicare expenditures. This proposed ru le reflects the Administration’s priority on improving payment for primary care services. Overall, payments for primary care specia lties would increase and payments to select other special ties would decrease due to seve ral changes in how we propose to calculate payments for CY 2013. Primary care payments would increase because of a proposed 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 a community mental health center. Primary care payments also would increase due to redistributions from proposed reductions in paym ents for other specialties. Because of the budget-neutral nature of this system, proposed de creases in payments in one service result in proposed increases in payments in others. Payments to primary care specialties are also impacted by the completion of the 4-yearCMS-1590-P 15

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). Proposed changes in how we calculate paym ent when certain services are furnished together would result in reductions in tota l payments projected to cardiologists and ophthalmologists. Capital-intensive specialties are projected to d ecrease due to proposed changes in how the interest rate used in th e PE calculation is estimated. Also, under our potentially misvalued codes initiative, , we propos e to adjust the payment rates for two common radiation oncology treatment delivery methods, in tensity-modulated radia tion treatment (IMRT), and stereotactic body radiation th erapy (SBRT) to reflect more realistic time projections based upon publicly available data. The combined effe ct of the PPIS transition and the latter two proposals would be a reduction in payments to ra diation therapy centers and radiation oncology. B. Background 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 rela tive value units (RVUs) based on the relative resources used in furnishing a service. Section 1848(c) of th e Act requires that nationa l RVUs be established for physician work, PE, and MP expense. Befo re the establishment of the resource-based relative value system, Medicare payment for ph ysicians’ services was based on reasonable charges. We note that throughout this propos ed rule, unless otherw ise noted, the term “practitioner” is used to describe both phys icians and nonphysician practitioners (such as physician assistants, nurse practi tioners, clinical nurse specialis ts, certified nurse-midwives, psychologists, or clinical social workers) who are permitted to bill Medicare under the PFS for

their services.CMS-1590-P 16

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. Initially, only the physician work RVUs were resource-based, and the PE and MP RVUs were based on average allowable charges. 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 services

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)CMS-1590-P 17

Section 121 of the Social Security Act Amendments of 1994 (Pub. L. 103-432), enacted on October 31, 1994, amended section 1848(c)(2)(C)(ii) of the Act and required us to develop resource-based PE RVUs for each physicians’ service beginning in 1998. We were to consider general categories of expenses (such as offi ce rent and wages of personnel, but excluding malpractice expenses) comprising PEs. 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 to delay implementation of the resource-based PE RVU system until January 1, 1999. In addition, sectio n 4505(b) of the BBA provided for a 4-year transition period from charge -based PE RVUs to resource-based PE RVUs.

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. Based on the requirement to transition to a resource-based system for PE over a 4-year period,

resource-based PE RVUs did not become fully effective until 2002. This resource-based system was based on two significant sources of actual PE data: the Clinical Practice Expert Panel (CPEP) data a nd the AMA’s Socioeconomic Monitoring System (SMS) data. The CPEP data were collected from panels of phys icians, practice administrators, and nonphysician health professionals (for exam ple, registered nurses (RNs)) nominated by physician specialty societies and other groups. The CPEP panels identified the direct inputs required for each physicians’ service. (We have since refined and revise d these inputs based on recommendations from the AMA RUC.) The SMS data provided aggregate specialty-specific

information on hours worked and PEs. Separate PE RVUs are established for pro cedures that can be furnished in both a nonfacility setting, such as a phys ician's office, and a facility setting, such as a hospital outpatient department (HOPD). The differen ce between the facility and nonfacility RVUs reflects the fact that a facility typically receives separate paymen t from Medicare for its costs ofCMS-1590-P 18

furnishing the service, apart from payment under the PFS. The nonfacility RVUs reflect all of

the direct and indirect PEs of fu rnishing a particular service. Section 212 of the Balanced Budget Refine ment Act of 1999 (BBRA) (Pub. L. 106-113) directed the Secretary of Health and Human Services (the Se cretary) to establish a process under which we accept and use, to the maximum extent practicable and consistent with sound data practices, data collected or deve loped by entities and organizations to supplement the data we normally collect in determining the PE com ponent. On May 3, 2000, we published the interim final rule (65 FR 25664) that set forth the crite ria for the submission of these supplemental PE survey data. The criteria were modified in re sponse to comments received, and published in the Federal Register (65 FR 65376) as part of a November 1, 2000 final rule. The PFS final rules published in 2001 and 2003, respectively, (66 FR 55246 and 68 FR 63196) extended the period during which we would accept these supplem ental 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) 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 of the SMS and th e supplemental surveys used prior to CY 2010. We note that in CY 2010, for oncology, clinical labor atories, and independen t diagnostic testing facilities (IDTFs), we continued to use the supplemental survey da ta to determine PE/HR valuesCMS-1590-P 19

(74 FR 61752). Beginning in CY 2010, we provide d for a 4-year transition for the new PE RVUs using the updated PE/HR data. In CY 2013, th e final year of the transition, PE RVUs are

calculated based on the new data. c. Resource-Based Malpractice RVUs Section 4505(f) of the BBA amended secti on 1848(c) of the Act requires that we implement resource-based MP RVUs for se rvices furnished on or after CY 2000. The resource-based MP RVUs were implemented in the PFS final rule with comment period published November 2, 1999 (64 FR 59380). Th e MP RVUs were based on malpractice insurance premium data collected from commercial and physician- owned insurers from all the States, the District of Colu mbia, and Puerto Rico.

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 pe riodic reviews of work RVUs and PE RVUs independently.

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). 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 theCMS-1590-P 20

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 MP 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 amendmen ts to Section 1848 of the Act, as enacted 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 recentlyCMS-1590-P 21

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-called '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 MP RVUs) are adjusted by geographic practice cost indices (GPCIs).

The GPCIs reflect the relative cost s of physician work, PE, and MP 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). 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 MP x GPCI MP)] x CF.CMS-1590-P 22

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. The CY 2012 PFS final ru le with comment period also addressed other policies including certain statutor y provisions including provisions of the Affordable Care Act and the Medicare Improvements for Patie nts and Providers Act (MIPPA) of 2008. In the CY 2012 PFS final rule with comment period, we announced the following for CY 2012: the total PFS update of -27.4 percent; the initial estimate for th e sustainable growth rate (SGR) of -16.9 percent; and the conversi on factor (CF) of $24.6712. These figures were

calculated based on the statutor y provisions in effect on N ovember 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 claims from January 1, 2012 through February 29, 2012. As a result,

the CY 2012 PFS conversion factor was revised to $34.0376 for claims with dates of service on or after January 1, 2012 through February 29, 201 2. In addition, 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;

● Section 305 - the payment to independe nt laboratories for the TC of physicianCMS-1590-P 23

pathology services furnished to certain hospital patients, and

● Section 307 - the five pe rcent increase in payments for mental health services. On February 22, 2012, the MCTRJCA was signed into law. Section 3003 extended the zero percent PFS update to the remainder 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 rela ted to therapy claims and caps. On March 1, 2012, as required by Section 1848(d)(1)(E) of the Act, we submitted to the Medicare Payment Advisory Committee (MedPA C) an estimate of the SGR and conversion factor applicable to Medicare payments for physic ians’ services for CY 2013. The actual values used to compute physician payments for CY 2013 will be based on later data and are scheduled to be published by November 1, 2012 as part of the CY 2013 PFS final rule.CMS-1590-P 24II. Provisions of the Proposed RuleA. Resource-Based Practice Expense (PE) Relative Value Units (RVUs)1. OverviewPractice expense (PE) is the portion of the resources used infurnishing the service that reflects the general categories ofphysician and practitioner expenses, such asoffice rent and personnel wages but excluding malpractice expenses, as specified insection 1848(c)(1)(B) ofthe Act. Section 121 of the Social Security Amendments of 1994 (Pub. L. 103-432), enacted onOctober 31, 1994, required us to develop a methodology for a resource-based system for determining PE RVUs for each physician’sservice. We develop PE RVUs by looking atthe direct and indirect physician practice resources involved in furnishing each service.Direct expense categories include clinical labor, medical supplies, and medical equipment. Indirectexpenses include administrativelabor, office expense, and all other expenses. The sections that follow provide moredetailed information about the methodology fortranslating the resources involved in furnishing each service into service-specific PERVUs. In addition, we note that section1848(c)(2)(B)(ii)(II) ofthe Act provides that adjustments inRVUs for a year may not cause total PFS payments to differ by morethan $20 million from what they would have otherwise been if theadjustments were not made. Therefore, if revisions to the RVUscause expenditures to change by more than $20 million, we make adjustments to ensure that expenditures do not increase or decreaseby more than $20 million. We refer readers to the CY 2010 PFS final rule with comment period (74 FR 61743 through 61748) for amore detailed explanation of the PE methodology.CMS-1590-P 252. Practice Expense Methodologya. Direct Practice ExpenseWe use a “bottom-up” approach to determine the direct PE by adding the costs of the resources (that is, the clinical staff, equipment,and supplies) typically involved with furnishing each service. The costs of the resources are calculated using the refined direct PE inputsassigned to each CPT code in our PE database, which are based onour review of recommendations received from the AMA RUC. Foradetailed explanation of the bottom-up direct PE methodology, including examples, we refer readersto the Five-Year Review of WorkRelative Value Units Under the PFS and Proposed Changes to thePractice Expense Methodology proposed notice (71 FR 37242) and theCY 2007 PFS final rule with comment period (71 FR 69629).b. Indirect Practice Expense per Hour DataWe use survey data on indirect PEs incurred per hour worked in developing the indirectportion 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 MonitoringSurveys (SMS). The AMA administered a new survey in CY2007 and CY 2008, the Physician Practice Expense Information Survey(PPIS), which was expanded (relative to the SMS) to include nonphysician practitioners(NPPs) paid under the PFS.The PPIS is a multispecialty, nationally representative, PE surveyof both physicians and NPPs using a consistent survey instrumentand methods highly consistent with those used for the SMS and the supplemental surveys. The PPIS gathered information from 3,656respondents across 51 physician specialty andhealthcare professional groups. We believe the PPIS is the most comprehensive source of PECMS-1590-P 26survey information available to date. Therefore, we used the PPIS datato update the PE/HR data for almost all of the Medicare-recognizedspecialties that participated inthe survey for the CY 2010 PFS.When we began using the PPIS data beginning in CY 2010, we did not change thePE RVU methodology itself or the manner inwhich the PE/HR data are used in that methodology. We only updated the PE/HR data based on the new survey. Furthermore, as weexplained in the CY 2010 PFS final rule with comment period (74FR 61751), because of the magnitude of payment reductions for somespecialties resulting from the use of the PPIS data, we finalized a 4-year transition (75 percent old/25 percent new for CY 2010, 50 percentold /50 percent new for CY 2011, 25 percent old /75 percent new for CY 2012, and 100 percent new for CY 2013) from the previousPERVUs to the PE RVUs developed using the new PPIS data.Section 1848(c)(2)(H)(i) of the Act requires us to use themedical oncology supplemental survey data submitted in 2003 foroncology drug administration services. Therefore, the PE/HRfor medical oncology, hematology, and hematology/oncology reflectsthecontinued use of these supplemental survey data.We do not use the PPIS data for reproductive endocrinology and spine surgery since these specialties currently are not separatelyrecognized by Medicare, nor do we have a method to blend these data with Medicare-recognized specialty data. Similarly, we donot usethe PPIS data for sleep medicine since there is not a full year of Medicare utilization data for that specialty.Supplemental survey data on independent labs, from the Collegeof American Pathologists, were implemented for payments inCY 2005. Supplemental survey data from the National Coalitionof Quality Diagnostic Imaging Services (NCQDIS), representingindependent diagnostic testing facilities (IDTFs), were blended with supplementarysurvey data from the American College of RadiologyCMS-1590-P 27(ACR) and implemented for payments in CY 2007.Neither IDTFs nor independentlabs participated in thePPIS. Therefore, we continue touse the PE/HR that was developed from their supplemental survey data.Consistent with our past practice, the previous indirectPE/HR values from the supplemental surveys for medical oncology,independent laboratories, and IDTFs were updated to CY 2006 using the MEI to put themon a comparable basis with the PPIS data.Previously, we have established PE/HR values for various specialties without SMS orsupplemental survey data by crosswalkingthem to other similar specialties to estimate a proxy PE/HR. For specialties that were part ofthe PPIS for which we previously used acrosswalked PE/HR, we instead use the PPIS-based PE/HR. We continue previous crosswalks for specialties that did not participate in thePPIS. However, beginning in CY 2010 we changed the PE/HR crosswalk for portable x-ray suppliersfrom radiology to IDTF, a moreappropriate crosswalk because these specialties are more similar to each other for physician time.For registered dietician services, the resource-based PE RVUs have been calculatedin accordance with the final policy thatcrosswalks the specialty to the “All Physicians” PE/HR data, as adopted in the CY2010 PFS final rule with comment period (74 FR 61752)and discussed in more detail in the CY 2011 PFS final rule with comment period (75 FR 73183).There were five specialties whose utilization data were newly incorporated intoratesetting for CY 2012. In accordance with the finalpolicies adopted in the CY 2012 final rule with comment period (76 FR 73036), weuse proxy PE/HR values for these specialties bycrosswalking values from other, similar specialties as follows: Speech Language Pathology from Physical Therapy; Hospice and PalliativeCare from All Physicians; Geriatric Psychiatry from Psychiatry; Intensive CardiacRehabilitation from Cardiology, and CertifiedNurseMidwife from Obstetrics/gynecology.CMS-1590-P 28For CY 2013, there are two specialties whose utilization data will be newly incorporated into ratesetting. We are proposing to useproxy PE/HR values for these specialties by crosswalking values from other specialties that furnish similar services as follows: CardiacElectrophysiology from Cardiology; and SportsMedicine from Family Practice. These proposed changes are reflected in the “PE HR” fileavailable on the CMS Website under the supporting data files for the CY 2013 PFS proposed rule athttp://www.cms.gov/PhysicianFeeSched/.As provided in the CY 2010 PFS final rule with comment period(74 FR 61751), CY 2013 is the finalyear of the 4-year transition tothe PE RVUs calculated using the PPIS data. Therefore, the CY2013 proposed PE RVUs were developed based entirely on the PPISdata,with the exceptions described in this section.c. Allocation of PE to ServicesTo establish PE RVUs for specific services,it is necessary to establish the direct and indirect PE associated with each service.(1) Direct CostsThe relative relationship between the directcost portions of the PE RVUs for any two services is determined by the relativerelationship between the sum of the directcost resources (that is, the clinical staff, equipment, and supplies) typically involved withfurnishing the services. The costs of theseresources are calculated from the refined direct PE inputs in our PE database. Forexample, if one service has a direct cost sum of $400 from our PE database andanother service has a direct cost sum of $200, thedirect portion of the PE RVUs of the firstservice would be twice as much as the direct portion of the PE RVUs for the secondservice.CMS-1590-P 29(2) Indirect CostsSection II.A.2.b. of this proposed rule describes the current data sources for specialty-specific indirect costs used in our PEcalculations. We allocated the indirect costs to the code levelon the basis of the direct costs specifically associated witha code andthe greater of either the clinical labor costs or the physician work RVUs. We also incorporatedthe survey data described earlier inthe PE/HR discussion. The general approachto developing the indirectportion of the PE RVUs is described as follows:•For a given service, we use the direct portion of the PE RVUs calculated as previously described and theaverage percentage that direct costs represent of total costs (basedon survey data) across the specialties that furnish the service todetermine an initial indirect allocator.For example, if the directportion of the PE RVUs fora given service was 2.00 and directcosts, on average, represented 25 percent oftotal costs for the specialties that furnished the service, the initial indirect allocatorwould be 6.00 since 2.00 is 25 percentof 8.00 and 6.00 is 75 percent of 8.00.•We then add the greater of the work RVUs or clinical labor portion of the direct portion of the PE RVUs to this initialindirect allocator. In our example, if this service had workRVUs of 4.00 and the clinical labor portion of the direct PE RVUswas1.50, we would add 6.00 plus 4.00 (since the 4.00work RVUs are greater than the 1.50 clinical labor portion) to get an indirectallocator of 10.00. In the absence of any further use of the survey data, the relative relationshipbetween the indirect costportions ofthe PE RVUs for any two services would be determined by the relative relationship between these indirect cost allocators. Forexample, if one service had anindirect cost allocatorof 10.00 and another service had anindirect cost allocator of 5.00, theindirectportion of the PE RVUs of the first service would be twice as great as the indirect portion of the PE RVUs for the second service.CMS-1590-P 30•We next incorporate the specialty-specific indirect PE/HR data into the calculation. As a relatively extreme example forthe sake of simplicity, assume in our previous example that, based on the survey data, the average indirect cost of the specialtiesfurnishing the first service with an allocator of 10.00 was half ofthe average indirect cost ofthe specialties furnishing thesecondservice with an indirect allocator of 5.00. In this case, theindirect portion of the PE RVUsof the first service would be equal to thatof the second service.d. Facility and Nonfacility CostsFor procedures that can be furnished ina physician's office, as well as in a hospital or facility setting, we establish two PERVUs: facility and nonfacility. The methodology for calculating PERVUs is the same for both the facility and nonfacility RVUs,but is applied independently to yield two separate PE RVUs. Because Medicare makes aseparate payment to the facility for itscostsof furnishing a service, the facility PE RVUs are generally lower than the nonfacility PE RVUs.e. Services with Technical Components(TCs) and Professional Components (PCs)Diagnostic services are generally comprised of two components: a professional component (PC) and a technical component(TC), each of which may be furnished independently or by differentproviders, or they may be furnished together as a “global’service. When services have PC and TCcomponents that can be billed separately,the payment for the global component equals thesum of the payment for the TC and PC. This is a result of using a weighted average of the ratioof indirect to direct costs across allthe specialties that furnish the global components, TCs, and PCs;that is, we apply the same weighted average indirect percentageCMS-1590-P 31factor to allocate indirect expenses to the global components, PCs, and TCs for a service. (The direct PE RVUs for the TC andPCsum to the global under the bottom-up methodology.)f. PE RVU MethodologyFor a more detailed description of the PE RVU methodology, we refer readers tothe CY 2010 PFS final rule with commentperiod (74 FR 61745 through 61746).(1) Setup FileFirst, we create a setup file for the PE methodology. The setup file contains the direct costinputs, the utilization for eachprocedure code at the specialty and facility/nonfacility place of servicelevel, and the specialty-specific PE/HR data from thesurveys.(2) Calculate the Direct Cost PE RVUsSum the costs of each direct input.Step 1: Sum the direct costs of the inputs for each service.Apply a scaling adjustmentto the direct inputs.Step 2: Calculate the current aggregate pool ofdirect PE costs. This is the product of the current aggregate PE (aggregatedirect and indirect) RVUs, the CF, and the averagedirect PE percentage from the survey data.Step 3: Calculate the aggregate pool of direct costs. This is the sum of the product of the direct costs for each service fromStep 1 and the utilization data for that service.CMS-1590-P 32Step 4:Using the results of Step 2 and Step 3calculate a direct PE scaling adjustmentso that the aggregate direct cost pooldoes not exceed the current aggregate direct cost pool and apply it to the direct costs from Step 1 for each service.Step 5: Convert the results of Step 4 to anRVU scale for each service. To do this,divide the results of Step 4 by the CF.Note that the actual valueof the CF used in this calculation does not influence the final directcost PE RVUs, as long as thesame CFis used in Step 2 and Step 5. Different CFs will result in different direct PE scaling factors, but this has no effect on thefinal directcost PE RVUs since changes in the CFsand changes in the associated direct scaling factors offset one another.(3) Create the Indirect Cost PE RVUsCreate indirect allocators.Step 6: Based on the survey data, calculate direct and indirect PE percentages foreach physician specialty.Step 7: Calculate direct and indirect PE percentages at the service level by taking a weighted average of the results of Step 6for the specialties that furnish the service. Note that for services with TCs and PCs, the direct and indirect percentages fora givenservice do not vary by the PC,TC, and global components.Step 8: Calculate the service level allocatorsfor the indirect PEs based on the percentages calculated in Step 7. The indirectPEs are allocated based on thethree components: the direct PE RVUs, theclinical PE RVUs, and the work RVUs.For most services the indirect allocator is: indirect percentage * (direct PERVUs/direct percentage) + work RVUs.There are two situations where this formula is modified:CMS-1590-P 33•If the service is a global service (that is, a service with global, professional,and technical components), then the indirectallocator is: indirect percentage (direct PE RVUs/direct percentage) + clinical PE RVUs + work RVUs.•If the clinical labor PE RVUs exceed the work RVUs (and theservice is not a global service), then the indirect allocator is:indirect percentage (direct PE RVUs/direct percentage) + clinical PE RVUs.(Note: For global services, the indirect allocatoris based on both the work RVUs and the clinical labor PE RVUs. We do this torecognize that, for the PC service, indirectPEs will be allocated using the work RVUs, and for the TC service, indirect PEs will beallocated using the direct PE RVUs and theclinical labor PE RVUs. This also allowsthe global component RVUs to equal the sumof the PC and TC RVUs.)For presentation purposes in theexamples in Table 1, the formulas were divided into two parts for each service.•The first part does not varyby service and is the indirectpercentage (direct PE RVUs/direct percentage).•The second part is either the work RVUs, clinical PERVUs, or both depending on whetherthe service is a global serviceand whether the clinical PE RVUs exceed the workRVUs (as described earlier in this step).Apply a scaling adjustment tothe indirect allocators.Step 9: Calculate the current aggregate poolof indirect PE RVUs by multiplying the current aggregate pool of PE RVUs bythe average indirect PE percentage from the survey data.CMS-1590-P 34Step 10: Calculate an aggregate pool of indirect PE RVUs for all PFS services by adding the product of the indirect PEallocators for a service from Step 8 and the utilization data for that service.Step 11: Using the results of Step 9 and Step10, calculate an indirect PE adjustmentso that the aggregate indirect allocationdoes 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, calculateaggregate pools of specialty-specific adjusted indirect PE allocators for allPFS services for a specialty by adding the product of the adjustedindirect PE allocator for eachservice and the utilization data forthat service.Step 13: Using the specialty-specific indirectPE/HR data, calculate specialty-specific aggregate pools of indirect PE for allPFS services for that specialty by adding the product of the indirect PE/HR for thespecialty, the physician time for the service, andthe specialty's utilization for the service across all services furnished by the specialty.Step 14: Using the results of Step 12 and Step 13, calculate the specialty-specific indirect PE scaling factors.Step 15: Using the results of Step 14, calculate an indirect practice cost index atthe specialty level by dividing eachspecialty-specific indirectscaling factor by the average indirectscaling factor for the entire PFS.Step 16: Calculate the indirect practice cost index at the service level to ensure the capture of all indirect costs. Calculate aweighted average of the practice cost index values for the specialties that furnish the service. (Note: For services with TCsand PCs,CMS-1590-P 35we calculate the indirect practice cost index across the global components, PCs, andTCs. Under this method, the indirect practicecost 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 practice cost index calculated in Step 16 to the service level adjusted indirectallocators calculated in Step 11to get the indirect PE RVUs.(4) Calculate the Final PE RVUsStep 18: Add the direct PE RVUs from Step 6 to the indirect PE RVUs from Step 17and apply the final PE budgetneutrality (BN) adjustment.The final PE BN adjustment is calculatedby comparing the results of Step 18 to thecurrent pool of PE RVUs. This final BNadjustment is required in order to redistribute RVUs from step 18 to all PE RVUs in the PFS and because certain specialties areexcluded from the PE RVU calculation for ratesetting purposes, butall specialties are includedfor purposes of calculating thefinalBN adjustment. (See "Specialtiesexcluded from ratesetting calculation" later in this section.)CMS-1590-P 36(5) Setup File Information•Specialties excluded from ratesetting calculation: For the purposes of calculatingthe PE RVUs, we exclude certainspecialties, such as certain nonphysician practitioners paid at a percentage of the PFS and low-volume specialties, from thecalculation. These specialties are includedfor the purposes of calculating the BN adjustment. They are displayed in Table 1.TABLE 1: SpecialtiesExcluded From Ratesetting CalculationSpecialty CodeSpecialty Description49Ambulatory surgical center50Nurse practitioner51Medical supply company with certified orthotist52Medical supply company with certified prosthetist53Medical supply company with certified prosthetist-orthotist54Medical supply company not included in 51, 52, or 53.55Individual certified orthotist56Individual certified prosthestist57Individual certified prosthetist-orthotist58Individuals not included in 55, 56, or 5759Ambulance service supplier, e.g., privateambulance companies, funeral homes, etc.60Public health or welfare agencies61Voluntary health or charitable agencies73Mass immunization roster biller74Radiation therapy centers87All other suppliers (e.g., drug and department stores)88Unknown supplier/provider specialty89Certified clinical nurse specialist95Competitive Acquisition Program (CAP) Vendor96Optician97Physician assistantA0HospitalA1SNFCMS-1590-P 37Specialty CodeSpecialty DescriptionA2Intermediate care nursing facilityA3Nursing facility, otherA4HHAA5PharmacyA6Medical supply company with respiratory therapistA7Department store1Supplier of oxygen and/or oxygen related equipment2Pedorthic personnel3Medical supply company with pedorthic personnelWe are proposing to calculate the specialtymix for low volume services (fewer than 100 billed services in the previous year)using the same methodology we use for non-low volume services. Wepreviously have used the survey data from the dominantspecialty for these low volume services. However, because theseservices have such low utilization, the dominant specialty tends tochange from year to year. Weare proposing to calculate a specialty mix for these services rather than use the dominant specialty inorder to smooth year-to-year fluctuations in PE RVUs due tochanges in the dominant specialty.●Crosswalk certain lowvolume physician specialties: Crosswalk the utilization of certain specialties with relatively lowPFS utilization to the associated specialties.•Physical therapy utilization: Crosswalk the utilization associated with all physical therapyservices to the specialty ofphysical therapy.CMS-1590-P 38•Identify professional and technical services not identified under the usual TC and 26 modifiers: Flag the services that arePC and TC services, but do not use TC and 26modifiers (for example, electrocardiograms).This flag associates the PC and TC withthe associated global code for use in creating the indirect PE RVUs. For example, the professional service, CPT code 93010(Electrocardiogram, routine ECG with at least 12 leads; interpretation and report only), is associated with the global service,CPTcode 93000 (Electrocardiogram, routine ECG with at least 12 leads; with interpretation and report).•Payment modifiers: Payment modifiers are accounted for in the creation ofthe file consistent withcurrent payment policy asimplemented in claims processing. For example, services billedwith the assistant at surgery modifier are paid 16 percent of the PFS amountfor that service; therefore, the utilization file is modified to only account for16 percent of any service that contains the assistant at surgerymodifier. Similarly, for those services to which volume adjustments are made to account for the payment modifiers, time adjustments areapplied as well. For time adjustments tosurgical services, the intraoperative portion in the physician time file is used; where it is notpresent, the intraoperative percentage fromthe payment files used by Medicare contractors to process Medicare claims is used instead.Where neither is available, we use the payment adjustment ratioto adjust the time accordingly. Table 2 details the manner inwhich themodifiers are applied.TABLE 2: Application of Payment Modifiers to Utilization FilesModifier Description Volume Adjustment Time Adjustment80,81,82 Assistant at Surgery 16% IntraoperativeportionAS Assistant at Surgery –Physician Assistant14% (85% * 16%) IntraoperativeportionCMS-1590-P 3950 orLT and RTBilateral Surgery 150% 150% of physiciantime51 Multiple Procedure 50% Intraoperativeportion52 Reduced Services 50% 50%53 Discontinued Procedure 50% 50%54 Intraoperative Care only Preoperative +IntraoperativePercentages on thepayment files used byMedicare contractorsto process MedicareclaimsPreoperative +Intraoperativeportion55 Postoperative Care only PostoperativePercentage on thepayment files used byMedicare contractorsto process MedicareclaimsPostoperativeportion62 Co-surgeons 62.5% 50%66 Team Surgeons 33% 33%We also make adjustments to volume and time that correspond toother payment rules, including special multiple procedure endoscopy rulesand multiple procedure payment reductions (MPPR) including theproposed ophthalmology and cardiovascular diagnostic services MPPRdiscussed in section II.B.4. of this proposed rule. We note thatsection 1848(c)(2)(B)(v) of the Act exempts certain reduced payments formultiple imaging procedures and multiple therapy services from the budget-neutrality calculation under section 1848(c)(2)(B)(ii)(II) of theAct. These multiple procedure payment reductions are notincluded in the development of the relative value units.CMS-1590-P 40For anesthesia services, we do not applyadjustments to volume since the average allowed charge is used when simulatingRVUs and therefore includes all discounts. A time adjustment of 33 percent is made only for medical direction of two to four casessince that it is the only occasionwhere time units are duplicative.●Work RVUs: The setup file contains the workRVUs from this proposed rule.(6) Equipment Cost Per MinuteThe 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 year if usage werecontinuous (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 (see74 FR 61753 through 61755 and section II.A.3. of the CY2011 PFS final rule with comment period).price = price of the particular piece of equipment.interest rate = sliding scale (see proposal below)life of equipment = useful life of the particular piece of equipment.maintenance = factor for maintenance; 0.05.The interest rate we have previouslyused was proposed and finalized during rulemaking for CY 1998 PFS (62 FR 33164). In theCY 2012 proposed rule (76 FR 42783), we solicited comment regarding reliable data on current prevailing loan rates for smallCMS-1590-P 41businesses. In response to that request, the AMA RUC recommended that rather than applying the same interest rate across allequipment, CMS should consider a “sliding scale” approach which varies the interest rate based on the equipment cost, useful life,and SBA (Small Business Administration) maximum interest ratesfor different categories of loansize and maturity. Themaximum interest rates for SBA loans are as follows:●Fixed rate loans of $50,000 or more must not exceed Prime plus2.25 percent if the maturity is less than 7 years, and Primeplus 2.75 percent if the maturity is 7 years or more.●For loans between $25,000 and $50,000, maximum rates must not exceed Prime plus3.25 percent if the maturity is lessthan 7 years, and Prime plus 3.75 percentif the maturity is 7 years or more.●For loans of $25,000 or less, the maximum interest rate must not exceed Prime plus4.25 percent if the maturity is less than7 years, and Prime plus 4.75 percent, ifthe maturity is 7 years or more.The current Prime rate is 3.25 percent.Based on that recommendation, for CY2013, we are proposing to use a “sliding scale” approach based on the current SBAmaximum interest rates for different categories of loan size (price of the equipment) and maturity (useful life of the equipment).Additionally, we are proposing toupdate this assumption through annual PFS rulemaking to account for fluctuations in the Primerate and/or changes to the SBA’s formula to determine maximum allowed interest rates.The effects of this proposal on direct equipment inputs arereflected in the CY 2013 proposeddirect PE input database,available on the CMS Website under the downloads for the CY 2013 PFS proposed rule athttp://www.cms.gov/PhysicianFeeSched/.CMS-1590-P 42Additionally, we note that the proposed PE RVUs included in Addendum B tothis proposed rule reflect the RVUs that result fromapplication of this proposal.CMS-1590-P 43TABLE 3: CALCULATION OF PE RVUS UNDER METHODOLOGY FOR SELECTED CODESStep Source Formula99213Office visit,est nonfacility33533CABG,arterial, singlefacility71020Chest x-raynonfacility71020-TCChest xraynonfacility71020-26Chest xraynonfacility93000ECG, completenonfacility93005ECG, tracingnonfacility93010ECG, reportnonfacility(1) Laborcost (Lab)Step 1 AMA 13.32 77.52 5.74 5.74 0.00 6.12 6.12 0.00(2) Supplycost (Sup)Step 1 AMA 2.98 7.34 3.39 3.39 0.00 1.19 1.19 0.00(3)Equipmentcost (Eqp.)Step 1 AMA 0.17 0.58 7.24 7.24 0.00 0.11 0.11 0.00(4) Directcost (Dir)Step 1 =(1)+(2)+(3) 16.48 85.45 16.38 16.38 0.00 7.42 7.42 0.00(5) Directadjustment(Dir. Adj).Steps 2-4 See footnote* 0.58 0.58 0.58 0.58 0.58 0.58 0.58 0.58(6) AdjustedLaborSteps 2-4 =Lab * Dir Adj =(1)*(5) 7.68 44.68 3.31 3.31 0.00 3.53 3.53 0.00(7) AdjustedSuppliesSteps 2-4 = Sup * Dir Adj =(2)*(5) 1.72 4.23 1.95 1.95 0.00 0.69 0.69 0.00(8) AdjustedEquipmentSteps 2-4 = Eqp * Dir Adj =(3)*(5) 0.10 0.34 4.17 4.17 0.00 0.06 0.06 0.00(9) AdjusteddirectSteps 2-4 =(6)+(7)+(8) 9.50 49.25 9.44 9.44 0.00 4.28 4.28 0.00(10)ConversionFactor (CF)Step 5 PFS 34.0376 34.0376 34.0376 34.0376 34.0376 34.0376 34.0376 34.0376(11) Adj.labor costconvertedStep 5 =(Lab * DirAdj)/CF=(6)/(10) 0.23 1.31 0.10 0.10 0.00 0.10 0.10 0.00(12) Adj.supply costconvertedStep 5 =(Sup * DirAdj)/CF=(7)/(10) 0.05 0.12 0.06 0.06 0.00 0.02 0.02 0.00CMS-1590-P 44Step Source Formula99213Office visit,est nonfacility33533CABG,arterial, singlefacility71020Chest x-raynonfacility71020-TCChest xraynonfacility71020-26Chest xraynonfacility93000ECG, completenonfacility93005ECG, tracingnonfacility93010ECG, reportnonfacility(13) Adj.equipmentcostconvertedStep 5 =(Eqp * DirAdj)/CF=(8)/(10) 0.00 0.01 0.12 0.12 0.00 0.00 0.00 0.00(14) Adj.direct costconvertedStep 5 =(11)+(12)+(13) 0.28 1.45 0.28 0.28 0.00 0.13 0.13 0.00(15) WorkRVUSetup File PFS 0.97 33.75 0.22 0.00 0.22 0.17 0.00 0.17(16) Dir_pctSteps 6,7 Surveys 0.31 0.18 0.31 0.31 0.31 0.31 0.31 0.31(17) Ind_pctSteps 6,7 Surveys 0.69 0.82 0.69 0.69 0.69 0.69 0.69 0.69(18) Ind.Alloc.Formula (1stpart).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 (18) 0.82 6.76 0.68 0.68 0.00 0.31 0.31 0.00(20) Ind.Alloc.Formulas(2nd part).Step 8 See Step 8 (15) (15) (15+11) (11) (15) (15+11) (11) (15)(21) Ind.Alloc. (2ndpart).Step 8 See (20) 0.97 33.75 0.32 0.10 0.22 0.27 0.10 0.17(22) IndirectAllocator(1st + 2nd)Step 8 =(19)+(21) 1.79 40.51 1.00 0.78 0.22 0.59 0.42 0.17(23) IndirectAdjustment(Ind. Adj.)Steps 9-11 See footnote** 0.40 0.40 0.40 0.40 0.40 0.40 0.40 0.40(24)AdjustedindirectallocatorSteps 9-11 =Ind Alloc * IndAdj0.72 16.25 0.40 0.31 0.09 0.23 0.17 0.07(25) Ind.PracticeCost Index(IPCI)Steps 12-16 See Steps 12 -161.12 0.79 0.92 0.92 0.92 0.94 0.94 0.94(26)AdjustedIndirectStep 17 = Adj.Ind Alloc* PCI=(24) * (25) 0.80 12.76 0.37 0.29 0.08 0.22 0.16 0.06CMS-1590-P 45Step Source Formula99213Office visit,est nonfacility33533CABG,arterial, singlefacility71020Chest x-raynonfacility71020-TCChest xraynonfacility71020-26Chest xraynonfacility93000ECG, completenonfacility93005ECG, tracingnonfacility93010ECG, reportnonfacility(28) PE RVUStep 18 =(Adj Dir + AdjInd) * budn=((14)+(26)) *budn1.08 14.19 0.64 0.56 0.08 0.34 0.28 0.06Note: 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.CMS-1590-P 46

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. We note that we will address comments on the interim direct PE inputs established in the CY 2012 PFS final rule with comment period in the CY 2013 PFS final

rule. 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 believe 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, dua l, or multiple lead implantable cardioverterdefibrillator system with interim physician analysis, review(s) and report(s)). Therefore, we are proposing to modify the direct PE input database to allocate 10 minutes to the pacemaker followup system for CPT codes 93294 and 93295. The proposed CY 2013 direct PE input database reflects these change s and is available on the CMS Website under the supporting data f iles for the CY 2013 PFS proposed rule with comment period at http://www.cms.gov/PhysicianFeeSched/ . We also note that the proposed PE RVUs included in Addendum B to this proposed rule reflect the RVUs that result from application of this proposal.

b. Clinical Labor for Pulmonary Rehabi litation Services (HCPCS Code G0424)CMS-1590-P 47

It has come to our attention that the dire ct PE input database includes 15 minutes of

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 believe that these 15 minut es should be added to the 15 minutes currently allocated to the Respiratory Ther apist (L042B) associated with this service. Therefore, we are proposing to modify the direct PE input data base to allocate 15 addi tional minutes to the Respiratory Therapist (L042B) (f or a total of 30 minutes) and delete the CORF social worker/psychologist (L045C) asso ciated with HCPCS code G0424. The proposed CY 2013 direct PE input database reflects these change s and is available on the CMS Website under the supporting data f iles for the CY 2013 PFS proposed rule with comment period at http://www.cms.gov/PhysicianFeeSched/ . We also note that the proposed PE RVUs included in Addendum B to this proposed rule reflect the RVUs that result from application of this proposal. 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.)CMS-1590-P 48

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 proposed rule with comment perio d, for a given service,

we use the direct costs associated with a service (clinical staff, equipmen t, 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 of

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 the 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 psyc hiatrists results in anom alous 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, andCMS-1590-P 49

is not on par with other services that require similar investments in capital equipment and highcost, disposable supplies. Historically, we have contractor-priced serv ices with resource costs that cannot be appropriately valued within the generally appl icable PE methodology used to price services

across the PFS. Because there is no mechanism to develop appropriate payment rates for these services within our current methodology, we are proposing to contractor price these codes 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 believe that CPT code 63650 should be reviewed to establish appropriate nonfacility inputs. We propos e to review CPT code 63650 and request 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 PECMS-1590-P 50

inputs to PE RVUs. We seek comment on es tablishing nonfacililty PE RVUs for CPT code

63650.CMS-1590-P 51

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 I.B.1.b. and I.B.1.c. of th is proposed rule, the statute also defines the PE and malpractice com ponents and provides specific guidance in the calculation of the RVUs for each of these compon ents. 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 categories of expenses (such as offi ce rent and wages of personnel, but excluding malpractice expenses) comprising practice expenses.” Section 1848(c)(1)(C) of the Act defines the malpractice component as “the portion of th e resources used in furnishing the service that reflects malpractice expenses in furnishing the se rvice.” Sections 1848 (c)(2 )(C)(ii) and (iii) of the Act specify that PE and malpractice expense RVUs shall be determined based on the relative PE/malpractice expense resources invol ved 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 andCMS-1590-P 52

review potentially misvalued codes and make appr opriate adjustments to the relative values of

those services identified as bei ng potentially misvalued. Section 3134(a) of the Affordable Care Act added a new section 1848(c)(2)( K) to the Act, which requires the Secretary to periodically identify potentially misvalued services using cert ain criteria and to review and make appropriate adjustments to the relative values for those services. Section 3134( a) of the Affordable Care Act also added a new section 1848(c)(2)(L) to the Ac t which requires the Secretary to develop a process to validate the RVUs of certain poten tially misvalued codes under the PFS, identified using the same criteria used to identify potentia lly misvalued codes, a nd to make appropriate adjustments. As discussed in section I.B.1.a. of this propos ed rule, each year we develop and propose appropriate adjustments to the RVUs, taking in to account the recommendations provided by the American Medical Association Specialty Soci ety 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 reco mmendations on the appropriate relative values for new, revised, and potentially misvalued PFS se rvices. We review these recommendations on a code-by-code basis and consider these recomme ndations in conjunction 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 other 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 RVUsCMS-1590-P 53

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 physicians' services as well as for other 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 work 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, or 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 potentiallyCMS-1590-P 54

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 the review process.'' Most recently, section 1848(c)(2)(K)(ii) of the Act (as added by section 3134(a) of the A ffordable Care Act) directed the Secretary to specifically ex amine, as determined appropriate , potentially misvalued services 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 re view 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 facilitateCMS-1590-P 55

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, secti on 3003 (b)(1) of the Middl e Class Tax Cut and Job Creation Act of 2012 (Pub. L. 112-96), requires that the Secretary conduct a study that examines options for bundled or episode-based payment to cover 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 procedur es. In conducting the st udy, the Secretary shall consult with medical professional societies and other relevant stakeholders. Additionally, the study shall include an examination of related private payer payment initiatives. This section also requires that not later 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 structuring paymen t that can improve payment accuracy and efficiency, assuming the bundling proposal has c onsidered the payment system, context, and included services. Current work on bundling to da te has targeted specif ic codes and sets of codes. Specifically, our ongoing work identify ing, reviewing, and validating the RVUs ofCMS-1590-P 56

potentially misvalued services on the PFS will s upport the development of this report. As detailed above, through the potentially misvalued codes initiative we are currently identifying for review codes that are frequently billed together 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. Additionally, in section II.B.2.d. of this CY 2013 PFS proposed rule, we discuss improving the value of the global surgical package and request public comment on methods of obtaining accurate a nd current data on E/M services furnished as part of global surgical procedures. This info rmation on measuring post-operative work in our current payment bundles also will inform our report to the Congress. We will continue to examine options for bundled or episode-based payments and will include our recommendations and implementation options in our report to the Congress submitted no later than January 1,

2013. 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, otherCMS-1590-P 57

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 process, we have reviewed over 1,000 pote ntially misvalued codes to refine work RVUs and direct PE inputs. We have adopted appropr iate 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 last year’s PFS proposed rule (CY 2012), we identified potentially misvalued codes in the category of “Other codes determined to be appropriate by the Secret ary,'' referring a list of the highest PFS expenditure servi ces, by specialty, that had not been recently reviewed (76 FR 73059 through73068). In the CY 2012 final rule w ith comment period we finalized policy to consolidate the review of physician work and PE at the same time (76 FR 73055 through 73958), and established a process for the annual public nomination of potentially misvalued services to replace the Five-Year revi ew process (76 FR 73058 through 73059). Below we discuss proposals that support our continuing efforts to appropriately identi fy, review, and adjust values for potentially misvalued codes. c. Validating RVUs of Potentially Misvalued Codes In addition to identifying and reviewing pot entially misvalued codes, section 3134(a) of the Affordable Care Act added section 1848(c)(2 )(L) of the Act, which specifies that the Secretary shall establish a form al process to validate RVUs under the PFS. The validationCMS-1590-P 58

process may include validation of work elements (such as time, mental effort and professional judgment, technical skill and physical effort, a nd stress due to risk) i nvolved with furnishing a service and may include validation of the pre-, po st-, and intra-service co mponents of work. The Secretary is directed, as part of the validation, to validate a samp ling 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 Act. Furthermore, the Secretary may conduct the validation using methods similar to those used to review pot entially misvalued codes, including conducting surveys, other data collection activ ities, studies, or other analyses as the Secretary determines to be appropriate to facilitate the 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 comment period (73054 through 73055). In CY

2012 we intend to enter into a contract to assist us in validating RVUs of potentially misvalued codes that will explore a model for the valida tion of physician work under the PFS, both for new and existing services. We plan to discuss this model 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 onCMS-1590-P 59

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 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 physician 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 with a wide range of E/ M services included with in the post-operative period. This is especially true among those with 90-day global periods. Mo re recently reviewed

codes tend to have fewer E/M services in the global period, and the work RVUs of those E/M

services are often accounted for in the value for the global surgical package. The value of lessCMS-1590-P 60

recently reviewed global surgeries frequently do not appear to include the full work RVUs of each E/M service in the global surgical package, and the numbers of E/M services included in the post-operative period can be inconsistent with in a family of procedures. For example, there is significant variation in the number and level of E/M services included in two transplantation procedures in Table 4. Pre-, intra-, and pos t-operative times, includ ing the number of postoperative visits, for each global surgical package can be found in the physician time file on the

CMS Website at http://www.cms.gov/PhysicianFeeSched/PFSFRN/ite mdetail.asp?filterTy pe=none&filterByDID =-99&sortByDID=4&sortOrder=desce nding&itemID=CMS1253669&intNumPerPage=10

. TABLE 4: Transplantation Procedures Sho wing a Significant Range in the Number of Included E/M Services E/M services included in global period CPT Code Short Descriptor Work RVU 99213 99231 99238 99291 Total E/M Work RVU 50360 Transplantation of kidney 40.90 9 12 1 10 64.13 47135 Transplantation of liver 83.64 7 0 0 0 6.79

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 notCMS-1590-P 61

able to review the level of E/M services th at 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. 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 report 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 and code of the E/M services actually furnished during the global period, there is very limited documentation on th e frequency or level of post- operative services. Without sufficient documentation, a review of the medical record cannot accurately determine the number

or level of E/M services furnishe d in the post-operative period.CMS-1590-P 62

As noted above, section 1848(c )(2)(K) of the Act (as adde d by section 3134 of the Affordable Care Act), which essentially codifi ed the potentially misvalued codes initiative, requires that the Secretary identify and review potentially misvalued serv ices 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 codes support better valuation of global surgi cal package codes. We have made e fforts to prioritize the review of

RVUs for services on the PFS that have not been re viewed recently or for se rvices where there is a potential for misuse. One of the priority catego ries for review of potentially misvalued codes is

services that have not been s ubject to review since the implem entation of the PFS (the so-called “Harvard-valued codes”). In the CY 2009 PFS pr oposed rule, we requested that the AMA RUC engage in an ongoing effort to re view the remaining Harvard-valu ed codes, focusing first on the high-volume, low intensity codes (73 FR 38589). For the Fourth Five-Year Review (76 FR 32410), we requested that the AMA RUC review serv ices that have not b een reviewed since the original implementation of the PFS with ut ilization greater than 30,000 (Harvard-valued— Utilization > 30,000). In section II.B.3 of this proposed rule, we propose to review Harvardvalued services with annual allowed char ges that total at l east $10,000,000 (Harvard-valued— Allowed charges ≥ $10,000,000), and request recommendations from the AMA RUC and other public commenters on appropriate va lues for these services. 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. These efforts are important, but we believe the usual review process does not go far enough to assess whether the valuati on of global surgical packages reflects the number and level of post-oper ative services that are typically furnished. ToCMS-1590-P 63

support our statutory obligation to identify and review potentially misvalued services and to respond to the OIG’s concern that global surgical package paymen ts are misvalued, we believe that we should begin gathering more information on the E/M services that are typically furnished with surgical procedures. Information rega rding the typical work involved in surgical procedures with a global period is necessary to evaluate whether certain surgical procedures are appropriately valued. While the AMA RUC revi ews and recommends RVUs for services on the PFS, we complete our own assessment of thos e recommendations, and may adopt different RVUs. However, for procedures with a global pe riod, the lack of claims data and documentation restrict our ability to review and a ssess the appropriateness of their RVUs. We are seeking comments on methods of obtaining accurate and current data on E/M services furnished as part of a gl obal surgical package. We are esp ecially interested in and invite comments on a claims-based data collection appro ach that would include reporting E/M services furnished as part of a global su rgical package, as well as other valid, reliable, generalizable, and robust data to help us identify the number and le vel of E/M services typically furnished in the global surgical period for specific procedures. We will carefully weigh all comments received as we consider ways to appropriately review values for global surgical packages.

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, the public nominated potentially misvalued codes for review. To allo w for public input and to preserve the public’s ability to identify and nominate potentially mi svalued codes for review under our annual potentially misvalued codes initiative, we esta blished a process by whic h the public can submitCMS-1590-P 64

codes, along with documentati on supporting the need for re view, on an annual basis. Stakeholders may nominate potentially misvalue d codes for review by submitting the code with supporting documentation during the 60-day public comment period following the release of the annual PFS final rule with comment period. Sup porting documentation for codes nominated for the annual review of potentially misvalue d 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.

● An anomalous relationship between the code being proposed for review and other

codes.

● 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).CMS-1590-P 65

● 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 would evaluate the supporting documentati on and assess whether they appear to be potentially misvalued codes appr opriate for review under the annua l process. In the following year’s PFS proposed rule, we would publish the list of nominated codes, and indicate whether each nominated code will be reviewed as potentially misvalued. This year is the first year we are considering codes we received through this public nomination process for potentially misvalued codes. In the 60 days following the release of the CY 2012 PFS final rule with comment peri od, we received nominations and supporting

documentation for review of the codes listed in Tables 5 and 6. A total of 36 CPT codes were nominated. The majority of the nominated codes were 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 Four th Five-Year Review of Work or the CY 2012 PFS proposed rule and finalized for CY 2012. Under this annual pub lic nomination process, we note that it would be highly unlikely that we would determine that a nominated code is appropriate for review under the potentially misvalued code s initiative if it had been reviewed in the years immediately preceding its nomination since we believe that the best information on the level of physician work and PE inputs already would have been availa ble through that recent review. Nonetheless, we evaluated the supporting documentation for each nominated code to ascertain whether the

submitted information demonstrated that the code is potentially misvalued.

TABLE 5: CPT Codes Nominated as Potent ially Misvalued in CY 2012 Final Rule Comment Period: Proposed ActionCMS-1590-P 66

CPT Code Short Descriptor Last Reviewed For: CMS Proposed Action Regulations.gov comment search

33282 Implant pat-active ht record CY 2000 Review and add nonfacility inputs. Not considered potentially misvalued. CMS-2011-0131-1422

33284 Remove pat-active ht record CY 2000 Review and add nonfacility inputs. Not considered potentially misvalued. CMS-2011-0131-1422

77336 Radiation physics consult CY 2003 (PE Only) Review as a potentially misvalued code. CMS-2011-0131-1617

94762 Measure blood oxygen level CY 2010 (PE Only) Propose revisions in the CY 2013 PFS proposed rule. CMS-2011-0131- 1615; CMS-2011-0131-1412; CMS2011-0131-1632 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 commenter asserted 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 phys icians perform these services in the office setting. The commenter requested that we esta blish appropriate payment for the services when furnished in a physician office. Specifically, they requested th at CMS establish nonfacility PE RVUs for these services. We do not consider the lack of prici ng in a particular setti ng as an indicator of a potentially misvalued code. However, given th at these services are now furnished in the nonfacility setting, we believe that CPT code s 33282 and 33284 should be re viewed to establish appropriate nonfacility inputs. We note, as did the commenter, that the valuation of a service under the PFS in a particular se tting does not address whether t hose services and the setting in which they are furnished are medically reasonabl e and necessary for a patient’s medical needs and condition. We propose to revi ew CPT codes 33282 and 33284 and request recommendations from the AMA RUC and other public commenters on the appropriateCMS-1590-P 67

physician work RVUs (as measured by time and inte nsity), and facility a nd nonfacility direct PE inputs for these services. Like CPT codes 33282 and 33284, stakeholders have requested that we establish appropriate payment for CPT code 63650 (Percu taneous implantation of neurostimulator electrode array, epidural) when furnished in an office setting. This request was not submitted as a potentially misvalued code nomination. However, given that these serv ices are now furnished in the nonfacility setting, we believe CPT code 63650 should be reviewed to establish appropriate nonfacility inputs. Please see section II.A.3 (Changes to Direct Inputs for Specific Services) for a discussion of spinal code stimul ation trial procedures in the nonfacility setting. CPT code 77336 (Continuing medical physics consultation, includ ing assessment of treatment parameters, quality assurance of dose delivery, and review of patient treatment documentation in support of the radiation oncol ogist, reported per w eek of therapy) was nominated for review as a potentially misvalued code. The commenter asserted that CPT code 77336 is misvalued because changes in the tec hnique for rendering continuing medical physics consultations have resulted in changes to the knowledge required, time, and effort expended, and complexity of technology associated with the tasks performed by the physicist other staff. Additionally the commenter believes 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. After eval uating the detailed s upporting information that the commenter provided, we believe there may have been chan ges in technology and other PE inputs since we last reviewed the service, and that further revi ew is warranted. As such, we propose to review CPT code 77336 as potentially misvalued and re quest recommendations from the AMA RUCCMS-1590-P 68

and other public commenters on the direct PE in puts for this service, and physician work RVUs and direct PE inputs for the other services 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. Commenters asserted that CPT code 94762 is misvalued because the time currently allocated to the various direct PE input s does not accurately reflect current practice.

Commenters also asserted that independent diagnostic testing facilities are not appropriately

accounted for in the current indi rect PE methodology. In response to these stakeholder concerns, we reviewed the PE inputs for CPT code 94762, which was last reviewed for CY 2010. We believe CPT code 94762 is misvalued, and we ar e proposing changes to the PE inputs for CY 2013. Following clinical review, we believe that th e current time allocated to clinical labor and supplies appropriately refl ects current practice. However, we believe that 480 minutes (8 hours) of equipment time for the pulse ox imetry recording slot and pulse oximeter with printer are more appropriate for this overnight monitoring proc edure code. As such, we are proposing this refinement to the direct PE inputs fo r CPT code 94762 for CY 2013. These proposed adjustments are 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 http://www.cms.gov/PhysicianFeeSched/

. 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 and is currently inte rim for CY 2012 and open to public comment. We will consider the content of the potentially misvalued code nomination and supportingCMS-1590-P 69

documentation for CPT code 53445 as comments on th e interim final value, and will address the

comments in the CY 2013 PFS final rule with comme nt period when we address the final value

of the CPT code. For purposes of CY 2013 rulemaking, we do not consider the other nominated codes, listed in Table 6 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 reviewed as potentially misvalued for CY 2013 or CY 2014. The supporting documentation for these serv ices generally mirrored the public comments previously submitted, to which CMS has already responded.

TABLE 6: CPT Codes Nominated as Potent ially Misvalued in CY 2012 Final Rule Comment Period: No Further Action Proposed CPT Code Short Descriptor 28820 Amputation of toe 28825 Partial amputation of toe 35188 Repair blood vessel lesion 35612 Artery bypass graft 35800 Explore neck vessels 35840 Explore abdominal vessels 35860 Explore limb vessels 36819 Av fuse uppr arm basilic 36825 Artery-vein autograft 43283 Lap esoph lengthening 43327 Esoph fundoplasty lap 43328 Esoph fundoplasty thor 43332 Transab esoph hiat hern rpr 43333 Transab esoph hiat hern rpr 43334 Transthor diaphrag hern rpr 43335 Transthor diaphrag hern rpr 43336 Thorabd diaphr hern repair 43337 Thorabd diaphr hern repair 43338 Esoph lengthening 47563 Laparo cholecystectomy/graph 49507 Prp i/hern init block >5 yr 49521 Rerepair ing hernia blockedCMS-1590-P 70

CPT Code Short Descriptor 49587 Rpr umbil hern block > 5 yr 49652 Lap vent/abd hernia repair 49653 Lap vent/abd hern proc comp 49654 Lap inc hernia repair 49655 Lap inc hern repair comp 53445* Insert uro/ves nck sphincter 60220 Partial removal of thyroid 60240 Removal of thyroid 60500 Explore parathyroid glands 95800 Slp stdy unattended *CPT code 53445 is currently interim and open for public comment. We are accepting as public comment the nomination information submitted and will address these comments in the CY 2013 PFS final rule with comment period. b. Potentially Misvalued Code Lists 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 allowedCMS-1590-P 71

services per year have been reviewed. Moving forward, we propose to review Harvard-valued services with Medicare allowed charges of $10 million or greater per year. The CPT codes meeting these criteria have relatively low Medicare utilization (as we have reviewed the services with utilization over 30,000), but account for significant Medicar e spending annually and have never been reviewed. We recognize that severa l of the CPT codes meeting these criteria have already been identified as pot entially misvalued through other screens and may currently be

scheduled for review for CY 2013. We also rec ognize that other codes m eeting these criteria have been referred by the AMA RUC to the CPT Ed itorial Panel. In these cases, we are not proposing re-review of these already identified se rvices, but for the sake of completeness, we include them as a part of this category of potenti ally misvalued services. We recognize that the relatively low Medicare utilization for these se rvices may make gathering information on the appropriate physician work and di rect PE inputs difficult. We request recommendations from the AMA RUC and other public commenters, and appreciate efforts expended to provide RVU and input recommendations to CMS for these lowe r volume services. Because survey sample

sizes could be small for these lower volume servi ces, we encourage the use of valid and reliable

alternative data sources and me thodologies when developing recomm ended values. In sum, we propose to review Harvard-valued CPT codes with annual allowed charges of $10 million or more as a part of the potentially misvalued codes initiative. Ta ble 7 lists the codes that meet these criteria using CY 2011 Medicare claims data.CMS-1590-P 72

TABLE 7: Harvard-valued CPT Co des 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 1 st 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 (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 Medicare beneficiaries, and procedure time assumptions are an important component in the development

of work and PE RVUs. Discussions in the acad emic community have in dicated that procedure times used for PFS ratesetting are overstated (McC all, N., J. Cromwell, et al. (2006). “Validation of physician survey estimates 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 management (E/M) services.” Med Care Res Rev 63(2): 236- 255. Cromwell, J., N. McCall, et al. (2010). “Missing productivity gains in the MedicareCMS-1590-P 73

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 equi pment resources in order to account for the time 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, theCMS-1590-P 74

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 codes 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 RVUsCMS-1590-P 75

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 the final rule, the AMA RUC and other stakeholders informed CMS that the direct PE input reco mmendation forwarded to CMS for IMRT treatment delivery (CPT code 77418) inadvertently omitted seven equipment items typically used in furnishing the service. These items had been used as direct PE inputs for the code prior to CY 2012. There is broad agreement among stakehol ders that these seven equipment items are typically used in furnishing the services described by CPT code 77418. We were unable to reincorporate the items for CY 2012. These omitted items are listed in Table 8. In consideration

of the comments from the AMA RUC and other st akeholders, we are pro posing to include the seven equipment items omitted from the RUC recommendation for CPT code 77418. These proposed adjustments are also reflected in the CY 2013 proposed direct PE input database,

available on the CMS Website under the downloa ds for the CY 2013 PFS proposed rule at http://www.cms.gov/PhysicianFeeSched/

. We note that the proposed PE RVUs included inCMS-1590-P 76

Addendum B to this proposed ru le reflect the RVUs that result from application of these proposals.

TABLE 8: 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 are wide 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 publicly available to Medicare be neficiaries and the general public clearly indicates that IMRT sessions typically last between 10 and 30 minutes. For example, the American Society for Radiation Oncology (ASTRO) publishes a patient fact sheet that explains that for all external beam radiation therapy, incl uding IMRT, “treatment is delivered in a series of daily sessions, each about 15 minutes long.” [“Radiation Therapy for Prostate Cancer: FactsCMS-1590-P 77

to Help Patients Make an Informed Decision” available for purchase at www.astro.org/MyASTRO/Products/Product.aspx?AstroID=6901 .] This fact sheet is intended 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 minut es were first assigned to the code for CY

2007 based on a recommendation from the AMA RU C. The most recent RUC recommendation that CMS received for CY 2012 rulemaking su pported continuing that procedure time assumption. In 2012, information publicly available to Medi care beneficiaries and the general public states that SBRT treatment typically lasts no long er than 60 minutes. For example, the American College of Radiology (ACR) and the Radiological Soci ety 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 have no reason to be lieve that information medical societies and practitioners offer to their cancer patients regard ing the IMRT or SBRT treatment experience is inaccurate or atypical. Therefore, we believe th at the typical procedure time for IMRT delivery is between 10 and 30 minutes and that the typi cal procedure time for SBRT delivery is under 60 minutes. The services are currently valued using procedure time assumptions of 60 and 90 minutes, respectively. We believe these procedur e time assumptions, distinct from necessaryCMS-1590-P 78

preparatory or follow-up tasks by the clinical labor, are clearly outdated and need to be updated using the 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 the case of these services, we believe that the need to reconcile the vast 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 are proposing to adjust the procedure time assumption for IMRT deliver y (CPT code 77418) to 30 minutes. We are proposing to adjust the procedure time assump tion for SBRT delivery (CPT code 77373) to 60 minutes. These procedure time assumptions reflect the maximum number of minutes reported as typical in publicly av ailable information. We note that in the case of CPT code 77418, the ‘accelerator, 6-18 MV’ (ER010) and the ‘collimato r, multileaf system w-autocrane’ (ER017) are used throughout the procedure and currently have no minutes allocated for preparing the equipment, positioning the patient, or cleaning th e room. Since these clinical labor tasks are associated with related codes typically reporte d at the same time, we are also proposing to allocate minutes to these equipment items to account for their use immediately before and following the procedure. All of these proposed adjustments are reflected in the CY 2013 proposed direct PE input database, available on the CMS Website under the downloads for the CY 2013 PFS proposed rule at http://www.cms.gov/ PhysicianFeeSched/ . We also note that the proposed PE RVUs included in Addendum B to this proposed rule reflect the RVUs that result from the application of this proposal. We request recommendations from the AMA RUC and other public commenters on the direct PE inputs for these servicesCMS-1590-P 79

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 to 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 Prosp ective Payment System (OPPS). We believe that such high-volume services th at are widely furnished in both nonfacility and facility settings are highly un likely to be more resource-inten sive in freestanding radiation therapy centers or physicians’ offices than when furnished in facilities 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 serv ices to higher acuity patients than the patients who receive services in physician offices or free -standing clinics. Given that the OPPS payment

rates are based on auditable data on hospital costs, we believe the seemingly counterintuitive relationship between the OPPS and nonfacility PFS payment ra tes reflects inappropriateCMS-1590-P 80

assumptions within the current direct PE inputs for CPT code 77418. The AMA RUC’s most recent direct PE input recommendations reflect the same procedure time assumptions used in developing the recommendations for CY 2002. As we explained above, we do not understand how the AMA RUC can recommend these assumptions in the context of the procedure time information available to the general public. We believe that using proc edure time assumptions that reflect the maximum times reported as typi cal to Medicare benefi ciaries will improve the accuracy of those inputs and the resu lting nonfacility payment rates. These two treatment delivery codes are PE onl y codes and are fairly unique in that the resulting 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 PFS established through the same methodology. As we previous ly stated, we believe that the procedure time assumptions for these kinds of services have not been subject to all of the same mechanisms recently used by CMS in the valuation of the physician work compone nt of PFS payment. In light of observations about publicly available proce dure times for CPT codes 77418 (IM RT treatment delivery) and 77373 (SBRT treatment delivery) and public awaren ess of potential advers e financial incentives associated with IMRT treatment delivery in particular, we believe that similar codes are 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 are proposing to review and make adjustments to CPT codes with sta nd alone procedure time assumptions used in developing nonfacility PE RVUs. These procedure time assump tions are not based on physician time assumptions. We are prioritizing for review CPT codes that have annual Medicare allowed charges of $100,000 or more, include direct equi pment inputs that amount to $100 or more, andCMS-1590-P 81

have PE procedure times of greater than 5 minutes . At this time, we are not including in this category services with payment rates subject to the OPPS cap (as specified in the statute under section 1848(b)(4) of the Act and li sted in Addendum G to this pr oposed 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 9. We recognize 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 9, we request r ecommendations from the AMA RUC and other public commenters on the appropriate direct PE i nputs for these services. We encourage the use

of valid and reliable alternative data sources when developing recommended values, including

electronic medical records and ot her independent data sources. We note that many of the CPT codes in Table 9 have been identified through ot her potentially misvalued code screens and have been recently reviewed. Given our observed con cerns with the inputs for the recently reviewed IMRT and SBRT direct PE inputs discussed above, we believe it is necessa ry to re-review other recently reviewed services with st and alone PE procedure time.

TABLE 9: 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 deliveryCMS-1590-P 82

CPT Code Short Descriptor 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

c. Services with Anomalous Time 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 this PFS proposed rule is availa ble on the CMS Website under the downloads for the CY 2013 PFS proposed rule at http://www.cms.gov/PhysicianFeeSched/

. In our review of potentially misvalued c odes and their inputs, we became aware of

several HCPCS codes that have anomalous times in our physician time file. Physician work is a measure of physician time and intensity, so th ere should be no services that have payable physician work RVUs but no physician time in the time file, and there should be no payable services with physician time in the time file and no physician work RVUs. For CY 2013 we are proposing to make the physician time file changes detailed belo w to address these anomalous

time file entries.CMS-1590-P 83

(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 is currently listed with 0 physician time. CPT code 94014 is a global service that includes CPT code 94015 (Patient-in itiated spirometric recording per 30-day period of time; recording (includes hook-up, reinforced e ducation, data transmissi on, data capture, trend analysis, and periodic recalibration)) (the technical component), and CPT code 94016 (Patientinitiated spirometric recording per 30-day period of time; physi cian review and interpretation only) (the professional component). 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, we are proposing to assign 2 minutes of pre-service evaluation time, and 20 minutes of intra-service time, which matches the times associated with CPT code 94016. These proposed adjustments are reflected in the physician

time file associated with this proposed rule, available on the CMS Website under the downloads for the CY 2013 PFS proposed rule at http://www.cms.gov/PhysicianFeeSched/. 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 is included in the physician time file. HCPCS codes G0117 and G0118 have a PFS procedure st atus indicator of T indicating that these services are only paid if there are no other se rvices payable under the PFS billed on the same date by the same provider.CMS-1590-P 84

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 propose to assign HCPC S code G0117 physician times matching CPT code 99212, and HCPCS code G0118 physician times matching CPT code 99211. Specifically, we are proposing 2 minutes of pre-se rvice time, 10 minutes of intra-serv ice 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-service time for HCPCS code G0118. These proposed adjustments are reflected in the physician time file associated with this proposed rule, available on the CMS Website under the downloads for the CY 2013 PFS proposed rule at http://www.cms.gov/PhysicianFeeSched/. 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 is not listed in the physician time file. After review of this HC PCS code, we do not beli eve that HCPCS code

G0128 describes a service that incl udes physician work. Time for a registered nurse to furnish

the service is included in the PE for the code. As such, for CY 2013, we propose to remove the physician work RVU for HCPCS code G0128. HC PCS code G0128 will continue 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 consistsCMS-1590-P 85

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 are not listed in the physician time file. HCPCS codes G0245, G0246, and G0247 have a procedure st atus 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, and 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 propose to assign HCPCS code G0245 physician times matching CPT code 99202, HCPCS codeCMS-1590-P 86

G0246 physician times matching CPT code 99212, and HCPCS code G0247 physician times matching CPT code 11040. Specifically, for HCPC S code G0245 we are pr oposing 2 minutes of pre-service time, 15 minutes of in tra-service time, and 5 minutes of immediate post-service time. For HCPCS code G0246 we are proposing 2 minutes of pre-service time, 10 minutes of intraservice time, and 4 minutes of immediate post -service time. For HCPCS code G0247 we are proposing 7 minutes of pre-service time, 10 minu tes of intra-service time, and 7 minutes of immediate post-service time. These proposed adju stments are reflected in the physician time file associated with this proposed rule, available on the CMS Webs ite under the downloads for the CY 2013 PFS proposed rule at http://www.cms.gov/ PhysicianFeeSched/. 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 is not list ed in the 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 final 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 cro sswalk in the CY 2003 final rule, af ter clinical review we believe that HCPCS code G0250 continues to require si milar work as CPT code 99211, and should have the same amount of physician time as CPT code 99211. As such, we are proposing to assign HCPCS code G0250 the same physician time as CPT code 99211. Specifically, for HCPCS code G0250 we are proposing 5 minutes of intra-servi ce time and 2 minutes of immediate post-service time. These proposed adjustments are reflected in the physician time file associated with thisCMS-1590-P 87

proposed rule, available on the CMS Website under the downloads for the CY 2013 PFS proposed rule at http://www.cms.gov/PhysicianFeeSched/

. 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 u tilization 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. (2) Review of Services with Stand Alone PE Procedure Time

There are a number of services that have no physician work RVUs, yet include physician time in the physician time file. Many of thes e services are not payable under the PFS or are contractor priced services where the physician time is not used to nationally price the services on the PFS. We are not proposing to remove the physician time from th e time file for these services

as the time has no effect on the calculation of RVUs for the PFS. However, there are severalCMS-1590-P 88

CPT codes, listed in Table 10, that are payable under the PFS and have no physician work RVUs yet include time in the physician time file. We are proposing to remove the physician time from

the time file for these seven CPT codes. Th ese proposed adjustments are reflected in the physician time file associated with this proposed rule, availa ble on the CMS Website under the downloads for the CY 2013 PFS proposed rule at http://www.cms.gov/PhysicianFeeSched/. TABLE 10: 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 secti on II.A.2. of this proposed rule, to create the IPCI used in the PE methodology, we calculate sp ecialty-specific aggregat e pools of indirect PE for all PFS services for that specialty by addi ng the product of the indirect PE/HR for the specialty, the physician time for th e service, and the specialty’s u tilization for th e service across all services performed by the specialty. The pr oposed removal of physician time from the CPT codes discussed above will affect the aggregate p ools of indirect PE at the specialty level.

However because the services discussed above ha ve low utilization and/or 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 RVUs at the individual code level.CMS-1590-P 89

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 reduced resources involved with furnishing the service for certain sets of services frequently fu rnished together. Under these policies, we reduce payment for the second and subseque nt services within the same MPPR categor y furnished in the same session or same day. These payment reductions reflect efficiencies th at typically occur in either the practice expense (PE) or professiona l work or both when services are furnished together. With the exception of a few codes that are always reported al ong with another code,

the Medicare PFS values services independently to rec ognize relative resour ces involved when the service is the only one furnished in a sessi on. While our general policy for MPPRs precedes the Affordable Care Act, this payment polic y approach addresses th e fourth category of potentially misvalued codes identified in section 1848(c)(2)(K) of the Act, as added by section 3134(a) of the Affordable Care Act, which is “m ultiple codes that are frequently billed in conjunction with furnishing a sing le service” (see 75 FR 73216). For CY 2013, we are proposing to continue ou r work to recognize resource efficiencies when certain services are furnished together. We are proposing to apply an MPPR to the technical component (TC) of certain diagnostic te sts. As discussed in the CY 2012 final rule with comment period (76 FR 73079), we are also proceeding with applying the current MPPR policy for imaging services to services furnishe d 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 th e same patient by a single physician or physiciansCMS-1590-P 90

in the same group practice on the same day, largely based on the presence of efficiencies in the PE and pre- and post-surgical physician work. Effective Janu ary 1, 1995, the MPPR policy, with this same percentage reduction, 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 th at we would 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 recognizes th at for the second and subsequent imaging procedures furnished in the same session, there are some efficiencies in clinical labor, supplies, and equipment time. In particular, certain clinic al labor activities and supplies are not 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, and 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,CMS-1590-P 91

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 the new OPPS payment cap added by the DRA, we decided in the PFS fi nal rule with comment period for 2006 that it would be prudent to retain the imaging MPPR at 25 percent while we continued to examine the appropriate payment levels (71 FR 69659). The DRA also exempted reduced expenditures attributable to the imaging MPPR policy from the PFS BN provision. Effective July 1, 2010, section 1848(b)(4)(C) of the Act, as added by section 3135(b)(1) of the Affordable Care Act increased the MPPR on the TC of imaging serv ices under the policy esta blished in the CY 2006 PFS final rule with comment period from 25 to 50 percent. Section 1848(c )(2)(B)(v)(IV) of the Act, as added by section 3135(b)(2) of the Af fordable Care Act exempted the reduced expenditures attributable to this furthe r change from the PFS BN provision. In the July 2009 U.S. Government A ccountability Office (GAO) report entitled, "Medicare Physician Payments: Fees Could Better Reflect Efficiencies Achieved when Services are Provided Together," the GAO reco mmended that we take further st eps 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 furnishedCMS-1590-P 92

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. 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 ultr asound procedures furnished to the same patient in the same session, regardless of the imaging modality and is not limited to contiguous body

areas.CMS-1590-P 93

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 code families (non-continguous body areas) that are subject to BN under the PFS. The complete list of codes subjec t 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 "always th erapy" services furnished to a single patient in a single day. It applies to serv ices 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 subsequent therapy services for multiple "always therapy" services furnished to a single patient in a single day.CMS-1590-P 94

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 secti on 1848 (which are services furnished in office settings, or non-institutional serv ices). The payment reduction percentage remains at 25 percent for therapy services furnished in institutional se ttings. Section 4 of the PPTRA exempted the reduced expenditures attributable to the ther apy 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 procedures or additiona l units of the same service is reduced by 25 percent. For non-institutional services, full paym ent is made for the se rvice or unit with the highest PE and payment for the PE component for the second and subsequent procedures or

additional units of the same serv ice 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 patient on the same day. It applies to services furnished by an individual or group pract ice or "incident to" a physician's service. The MPPR applies when mul tiple therapy services are billed on the same date of service for one patient by the same practitioner or facility under the same National Provider Identifier (NPI), regard less of whether the services are furnished in one therapy discipline or multiple disciplines, including physical therapy, occupational therapy, or speech-language pathology. 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 theCMS-1590-P 95

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, a llows physicians to refer Medicare patients 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 pr ovisions of section 1848(c)(2)(K ) of the Act, in the CY 2012 final rule (76 FR 73071), we expanded the MPPR to the PC of Advanced Imaging Services (CT, MRI, and Ultrasound), that is, the same list of codes to whic h the MPPR on the TC of advanced imaging already applied (see Addendum F). Thus , this MPPR policy now applies to the PC and the TC of certain diagnostic imaging codes. Specifically, we expanded the payment reduction currently applied to the TC to apply also to the PC of the second and subsequent advanced imaging services furnished by the same physician (or by two or more physicians in the same group practice) to the same patient in the same session on the same day. However, in response to public 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.CMS-1590-P 96

Under this policy, full payment is made for th e PC of the highest paid procedure, and payment is reduced by 25 percent for the PC for each additional procedure furnished to the same patient in the same session. This policy was ba sed on the expected efficiencies in furnishing multiple services in the same session due to duplic ation of physician work, primarily in the preand post-service periods, with smaller effi ciencies 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, but excluding diagnostic and screening mammography). Add-on codes that are always furnishedCMS-1590-P 97

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 theCMS-1590-P 98

approximately 560 HCPCS codes that are curren tly subject to the OPPS cap. The savings

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 patient on the same day. Due to a technical erro r, the MPPR is not bei ng applied to CPT codes 78306 (Bone imaging; whole body when followed by CPT code 78320 (Bone imaging; SPECT). We will apply the MPPR to these pr ocedures effective January 1, 2013. (2) Apply the MPPR to the PC and TC of Adva nced Imaging Procedures to Physicians in the Same Group Practice

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 patient in the same session by a single physician or by multiple physicians in the same group practice. Due to operational li mitations, we were not able to apply this MPPR to multiple physicians in the same group practi ce during CY 2012. In addition, after we issued the CY 2012 final rule with comment period, some stakeholders asserted 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. We have resolv ed the operational problem s 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 (sameCMS-1590-P 99

group NPI). Under this policy, th e MPPR will apply when one or more physicians in the same group practice furnish services to the same patient, in the same session, on the same day. This policy is consistent with other PFS MPPR policie s for surgical and therapy procedures. We continue to believe that the typi cal efficiencies achieved when the same physician is furnishing multiple procedures also accrue when different physicians in the same group furnish multiple procedures involving the same patient in the same session. It is our gene ral intention to apply this and future MPPRs to services furnished by one or more physicians in the same group unless special circumstances warrant a more limited appli cation. In such circumstances, we will note in our proposal that an MPPR does not apply to one or more physicians in the same group as other MPPR policies do. We continue to welcome pub lic comment on this provision as it applies to advanced diagnostic imaging and to the MPPR policy generally. 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 other diagnostic services. For CY 2013, we ex amined other diagnostic services to determine whether there typically are efficiencies in th e technical component when multiple diagnostic services are furnished together on the same day. We have conducted an analysis of the most frequently furnished code combinations for all diagnostic services usi ng CY 2011 claims data. Of the several areas of diagnostic tests that we examined, we found that billing patterns and PE inputs indicated that cardiova scular and ophthalmology diagnostic procedures, respectively, are frequently furnished together and that there is so me duplication in PE inputs when this occurs. For cardiovascular diagnostic services, we review ed the code pair/combinations with the highest utilization in code ranges 75600 th rough 75893, 78414 through 78496, and 93000 throughCMS-1590-P 100

93990. For ophthalmology diagnostic services, we revi ewed the code pair/c ombinations with the highest utilization in code ranges 76 510 through 76529 and 92002 through 92371. The most frequently billed cardiovascula r and ophthalmology diagnostic code combinations 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 patient on the same da y, 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.

● 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.

● QA documentation.CMS-1590-P 101

● Making phone calls.

● Reviewing prior X-rays, lab and echos. We analyzed the CY 2011 claims data for the most frequently billed cardiovascular and ophthalmology diagnostic code combinations in order to determine the level of duplication present when multiple services are furnished to the same patient 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 minut es were associated. 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 reduction by code pair, we belie ve 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. We propose to apply an MPPR to TC-onl y services and to the TC portion of global services for the procedures listed in Tables 12 and 13. The MPPR wouldCMS-1590-P 102

apply independently to second and subsequent cardiovascular servi ces and to second and subsequent ophthalmology services. We propose to make full payment for the TC of the highest priced procedure and to make payment at 75 perc ent (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 gr oup practice NPI) to the same patie nt on the same day. We are not proposing to apply an MPPR to the PC for car diovascular and ophthalmology services at this time. In Table 11, we provide examples illust rating the current and proposed payment amounts: TABLE 11: Illustration of Current and Proposed Payments Sample Cardiovascular Payment Reduction *

Code Code Total Current Total Proposed 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 Proposed Payment 92235 92250 Payment Payment Calculation PC $46.00 $23.00 $69.00 $69.00 no reduction TC $92.00 $53.00 $145.00 $131.75 $92 + (.75 x $53) Global $138.00 $76.00 $214.00 $200.75 $69 + $92 + (.75 x $53) *Dollar amounts are for illustrative purposes and may not reflect actual payment amounts.

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. 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 policy on surgical and nuclear medicine diagnostic proced ures and advanced imaging procedures which applies a 50 percent reduction to second and subs equent procedures, and our more recent policyCMS-1590-P 103

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 ge neral statutory PFS BN provisio n. In summary, for services furnished on or after January 1, 2013, we pl an to apply the MPPR to nuclear medicine procedures to CPT codes 78306 (Bone imaging; whole body when followed by CPT code 78320 (Bone imaging; SPECT). We plan to apply th e MPPR to the PC and the TC of advanced imaging procedures to multiple physicians in the same group practice (same group NPI). Therefore, the MPPR will apply when one or more physicians in the same group practice furnish services to the same patient, in the same sessi on, on the same day. Finally, we propose to apply an MPPR to TC-only services and to the TC portion of global services for diagnostic cardiovascular and ophthalmology procedures. The reduction would apply independently to cardiovascular and ophthalmology services. We pr opose to make full payment for the TC of the highest priced procedure and payment at 75 percent 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 patient on the same day. TABLE 12: Diagnostic Cardiovascular Serv ices Subject to the Multiple Procedure Payment ReductionCMS-1590-P 104

Code 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 75650 Artery x-rays head & neck 75658 Artery x-rays arm 75660 Artery x-rays head & neck 75662 Artery x-rays head & neck 75665 Artery x-rays head & neck 75671 Artery x-rays head & neck 75676 Artery x-rays neck 75680 Artery x-rays neck 75685 Artery x-rays spine 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 75774 Artery x-ray each vessel 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 Code Descriptor 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 imaging 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 78496 Heart first pass add-on 93005 Electrocardiogram tracing 93017 Cardiovascular stress test 93318 Echo transesophageal intraop 93024 Cardiac drug stress test 93025 Microvolt t-wave assess 93041 Rhythm ecg tracing 93225 Ecg monit/reprt up to 48 hrs 93226 Ecg monit/reprt up to 48 hrs 93229 Remote 30 day ecg tech supp 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 personCMS-1590-P 105

Code Descriptor 93289 Icd device interrogate 93290 Icm device eval 93291 Ilr device interrogate 93292 Wcd device interrogate 93293 Pm phone r-strip device eval 93296 Pm/icd remote tech serv 93303 Echo transthoracic 93304 Echo transthoracic 93306 Tte w/doppler complete 93307 Tte w/o doppler complete 93308 Tte f-up or lmtd 93312 Echo transesophageal 93314 Echo transesophageal 93318 Echo transesophageal intraop 93320 Doppler echo exam heart 93321 Doppler echo exam heart 93325 Doppler color flow add-on 93350 Stress tte only 93351 Stress tte complete 93701 Bioimpedance cv analysis 93724 Analyze pacemaker system 93786 Ambulatory BP recording 93788 Ambulatory BP analysis 93880 Extracranial study Code Descriptor 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 eye 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 Code Descriptor 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 photographyCMS-1590-P 106

TABLE 14: Frequently Billed Diagno stic Cardiovascular Combinations Code Range 75600-75893 Code Descriptor Code Descriptor Code Descriptor Code Descriptor 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 Vein x-ray chest 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 78414-78496 Code Descriptor Code Descriptor Code Descriptor Code Descriptor 78452 Ht muscle image spect mult 93306 Tte w/doppler complete 78452 Ht muscle image spect mult 93017 Cardiovascular stre ss test 78452 Ht muscle image spect mult 93306 Tte w/doppler complete 93880 Extracranial study 78452TC Ht muscle image spect mult 93017 Cardiovascular stre ss 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 Vascular study 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 studyCMS-1590-P 107

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 nerve 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 photos 76512 Ophth us b w/non-quant a 92134 Cptr ophth dx img post segmt 76512 Ophth us b w/non-quant 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 segmt 76512 Ophth us b w/non-quant 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 photographyCMS-1590-P 108

C. 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 malpracti ce. 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 the 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 RVUCMS-1590-P 109

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. For CY 2013, we will continue our current approach for determining malpractice RVUs for new/revised codes. We will publish a lis t of new/revised codes and the malpractice crosswalk(s) used for determining their malpractic e RVUs in the final rule with comment period. The CY 2013 malpractice RVUs fo r new/revised codes will be implemented as interim final

values in the CY 2013 PFS final rule with comme nt period, where they will be subject to public comment. They will then be finalized in the CY 2014 PFS final rule with comment period.CMS-1590-P 110

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 (MP)). While requiring 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 to extend the 1.0 floor for the work GPCIs through February 29, 2012 by section 303 of the Temporary Payroll Tax Cut Continuation Act of 2011 (TPTCCA) (Pub. L. 112-78). The statute was again amended by

section 3004 of the Middle Class Tax Relief and Job Creation Act of 2012 (MCTRJCA) (P.L. 112-399) to extend the 1.0 work floor for GPCIs throughout the remainder of CY 2012 (that is,

for services furnished no later than Decembe r 31, 2012). During the development of the CY 2012 PFS final rule with comment period, neither TPTCCA nor MCTRJCA had been enacted and, because the work GPCI floor was set to ex pire at the end of 2011, the GPCIs published in

Addendum E of the CY 2012 PFS fina l rule with comment period di d not reflect the 1.0 work floor. Appropriate changes to the CY 2012 GPCI s were made to reflect the 1.0 work floor required by section 303 of the TPTCCA a nd section 3004 of the MCTRJCA. Since the 1.0 work GPCI floor provided in section 1848 (e)(1)(E) of the Act is set toCMS-1590-P 111

expire prior to the implementation of the CY 2013 PFS, the proposed CY 2013 work GPCIs and summarized geographic adjustment 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 frontier States are applicable in CY 2013.

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 updated from 52.466 percent to 48.266 pe rcent, 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 updated 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 geographic cost differences. Lastly, the cost share weight for the MP GPCI was revised from 3.865 percent to 4.295 percen t. Table 16 displays the cost share weights

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.CMS-1590-P 112

TABLE 16: Cost Share Weights finalized in CY 2012 GPCI Update Expense Category Cost Share Weights % Physician 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 po licies including the use of 2006 through 2008 American Community Survey (ACS) two-bedroom re ntal data as a proxy for the relative cost difference in physician office rent. In addition, we created a purch ased services index 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 utilize Bureau of Labor Statistics (BLS) Occupationa l Employment Statistics (OES) data to capture the “full range” of occupations included in the offices of physician industr y to calculate the nonphysician employee wage component (also referred to as th e employee wage index) of the PE GPCI, we finalized a policy of using 100 percent of the to tal wage share of nonphysician occupations in the offices of physicians' industry to calculate the nonphysician em ployee wage component of the

PE GPCI.

2. Recommendations from the Institute of Medicine Concurrent with our CY 2012 rulemaking cycle, the Institute of Me dicine released the final version of its first of two anticipated repor ts entitled “Geographic Ad justment in Medicare Payment: Phase I: Improving Accuracy, Sec ond Edition” on September 28, 2011. This report included an evaluation of the accuracy of geogra phic adjustment factors for the hospital wage index and the GPCIs, as well as the methodology and data used to calculate them. Several of the policies that we finalized in CY 2012 rulemaking addressed se veral of the recommendationsCMS-1590-P 113

contained in the Institute of Medicine’s first re port. Because we did not have adequate time to completely address the Institute of Medicine’s Phase I report recommendations during CY 2012 rulemaking, we have included a discussion in this proposed rule about the recommendations that were not implemented or discussed in the CY 2012 final rule with comment period. We look forward to receiving comments on these recommendations.

The Institute of Medicine’s second report, expected in summ er 2012, will evaluate the effects of geographic adjustment factors (hospital wage index and GPCIs) on the distribution of the healthcare workforce, quality of care, population health, and the abil ity to provide efficient, high

value care. We did not receive the Institute of Medicine’s Phase II report in time for consideration for this CY 2013 proposed rule. We intend to addr ess the Institute of Medicine’s recommendations in the Phase II report once we have had an opportunity to fully eval uate the report and its

recommendations.

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 are not including any proposals related to the GPCI s in this proposed rule. In response to public inquiries abou t exceptions to the calculated GP CIs, we are providing 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 discuss recommendations from the

first Institute of Medicine re port that were not addressed du ring CY 2012 rulemaking in this proposed rule.

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 willCMS-1590-P 114

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 St ates determined to be frontier States. There are no proposed changes to those States identified as “Frontier States” for the CY 2013 proposed rule. The following States are considered to be “Frontier States” for CY 2013: Montana, North Dakota, Nevada, South Dakota, and Wyoming. b. GPCI Assignments for the Puerto Rico Payment Locality Recently, we have received inquiries from representatives of the Puerto Rico medical community regarding our policies for determin ing the GPCIs for the Puerto Rico payment locality. While we are not making any proposals related to the GPCIs for Puerto Rico, in response to those inquiries, we are providing the following discussion regarding the GPCIs assigned to the Puerto Rico payment locality. We anticipate recalculating all the GPCI’s in the seventh GPCI update currently anticipated in 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 of

PE GPCI. We use 2006-2008 ACS data to calculate the office rent component of the PE GPCI. Finally, we use 2006-2007 malprac tice premium data to calcula te the MP 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,CMS-1590-P 115

we do not use data on the price of equipment, supplies, and expenses across localities in calculating PE GPCIs. With the exception of the MP 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 re ntal values derived from the 2006-2008 ACS indicate that the costs associated with opera ting a physician practice in Puerto Rico are the lowest among all payment localities.

In order to calculate the MP 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 pg. 41), for the fourth, fifth, and sixth GPCI update s we were not able to collect this data for the Puerto Rico payment locality. Therefore, we carried over th e MP GPCI value of 0.249 from previous GPCI updates when malpractice premium data were last available. It is impor tant that we have a source for more current malpractice premium da ta for Puerto Rico for use in the upcoming seventh GPCI update. We are working with the rele vant officials in Puerto Rico to acquire these data for use in future rulemaking. We would encourage comments from stakeholders regarding potential data sources that may be available for calculating the Puerto Rico malpractice GPCI. For a detailed discussion regard ing the methodology used to calcul ate the various components of the Puerto Rico GPCIs, we refer readers to our contractor’s report from November of 2010 entitled “Final Report on the Sixth Update of the Geographic Practice Cost Index for the Medicare Physician Fee Schedul e” available on our Website at http://www.cms.gov/PhysicianFeeSched/downloads/GPCI_Report.pdf

. c. Expiration of GPCI Work Floor The work GPCIs are designed to capture the re lative costs of physician labor by MedicareCMS-1590-P 116

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 which 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 GPCI reflects 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 are not proposing 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. As noted above, 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 until it was temporarily extended through February 29, 2012 by section 303 of the TPTCCA. The GPCI work floor was extended throughout the remainder of CY 2012 by section 3004 of the MCTRJCA. 4. Institute of Medicine Phase I Report a. Background At our request, the Institute of Medicine is conducting a study of the geographic adjustment factors in Medicare payment. It is a comprehensive empirical study of the geographic adjustment factors established unde r sections 1848(e) (G PCI) and 1886(d)(3)(E) of the Act (hospital wage index). These adjustments are designed to ensure Medicare payment fees and rates reflect differences in input costs acro ss geographic areas. The factors the Institute of Medicine is evaluating include the following:CMS-1590-P 117

● 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 ma rketplace, the Institute of Medicine is also evaluating and considering 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.

The Institute of Medicine’s first report entitled “Geogra phic Adjustment in Medicare Payment, Phase I: Improving Accu racy” evaluated the accuracy of geographic 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.CMS-1590-P 118

● 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 with 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 Statistics to analyze confidential data for the Centers for

Medicare & and Medicaid Services.

● 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 http://www.iom.edu/Reports/2011/Geographic-Adju stment-in-Medicare-Payment-Phase-I-Improvin g-Accuracy.aspx

. As previously noted, the Institute of Medi cine will consider the role of MedicareCMS-1590-P 119

payments on matters such as the distribution of the healthcare workfor ce, population health, and the ability of providers to produce high-value, high-quality health ca re in its final report anticipated in summer 2012. We were not able to evaluate the recommenda tions contained in the Institute of Medicine’s Phase II report, in tim e for discussion in this proposed rule.

b. Institute of Medicine Recomme ndations Implemented in CY 2012 In the CY 2012 final rule with comment period, we addressed three of the recommendations offered by the Institute of Medici ne in their Phase I report. Specifically, the final CY 2012 GPCIs utilized the full range of non-physician 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 non- clinical 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 regardi ng the Institute of Medicine’s remaining recommendations, we are providing a summary an alysis of these recommendations in this proposed rule below. We will provide our tec hnical analyses of the remaining Institute of Medicine Phase I recommendations in a report that will be released on the PFS Website at http://www.cms.gov/PhysicianFeeSched

. Since we have not yet had an opportunity to review

the recommendations in the Institute of Medici ne’s Phase II report, these analyses focus exclusively on the recommendations as presented in the Institute of Medicine’s Phase I release. c. Discussion of Remaining Inst itute of Medicine 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.CMS-1590-P 120

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 local ities; 34 localities are Statewide areas (that is , only one locality for the entire State). There are 52 localities in the other 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, Mary land, and Virginia suburbs, 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 fina l 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 physician specialties. Recognizing this, the Congress repl aced the reasonable char ge system with the Medicare PFS in the Omnibus Budget Reconciliat ion Act (OBRA) of 1989, effective January 1, 1992. Payments under the fee schedule are based on the relative resource s required to provide services and vary among areas as resource 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. As a result, a study was begun in 1994 which resulted in a comprehensive locality revision, which was impl emented in 1997 (61 FR 59494).CMS-1590-P 121

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 currently require that changes to the PFS locality structure 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 options ( http://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 orCMS-1590-P 122

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 not 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 co mments on the contract or's 2008 draft report detailing four different local ity configurations, we refer readers 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 thisCMS-1590-P 123

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 A lternative GPCI Payment Locality Structures – Final Report,” is accessible from the CMS PFS Web page under the heading “Review of Alternative GPCI Payment Locality Structures – Fina l Report.” The report may also be accessed directly from the following link: http://www.cms.gov/PhysicianFeeSched/downloa ds/Alt_GPCI_Payment_L ocality_Structures_R eview.pdf (ii) Institute of Medici ne Recommendation 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- tiered system for defining fee sc hedule 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 states 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.CMS-1590-P 124

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 office in each MSA. The third step sets each physician’s employee index wage equal to the estimated area index wage (calculated in Step 2) of the county in which the physician office is located. Because the out-commuting adjustment envisioned by the Institute of Medicine in the second step vari es by county, the employee wage index value—and

thus the PE GPCI as a whole— would also 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, the purchased services i ndex, and the MP GPCI. An MSA is made up of one or more counties, including the counties that contain the core urban ar ea with a population of 50,000 or more, as well as surrounding counties that exhibit a high degree of social and economic integration (as measured by commuting patterns) with the urban core. MSAs are designed to be socially and economically integr ated units based on the share of workers whoCMS-1590-P 125

commute to work within the urban core of each MSA. Implementing an MSA-based locality structure would expand the number of fee sche dule areas from 89 to upwards of 400 plus additional MSAs for U.S. territories (for exam ple, 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, Virginia 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 paymentCMS-1590-P 126

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, Second Edition” on September 28, 2011 pg 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 Me dicine’s three tiered locality recommendation, or any other potential locality revi sion, we need to assess, and prep are to inform the public of, the impact of any change for all Medicare stakeholde rs. The Institute of Medicine’s Phase II report,

scheduled for release this summe r 2012, should contain an evaluati on of many of these important factors including:CMS-1590-P 127

● 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 prematur e to propose any change to the P FS localities at this time. In conjunction with a specifi c proposal for changing the lo cality configuration during future rulemaking, we would provide detailed 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 are making no proposal in this proposed rule to change the current locality configuration, we are seeking public comment regarding Instit ute of Medicine’s recommended three-tiered PFS payment locality definition. In addition, we will make our technical analyses of

the Institute of Medicine local ity recommendations, specific to th e Phase I report, available on

the PFS Website at http://www.cms.gov/PhysicianFeeSched/

.CMS-1590-P 128

(B) Institute of Medicine Recommendation 2-2 : The data used to construct the hospital wage index and the physician geographic adjustment factor should come from all hea lthcare employers (Geographic Adjustment in Medicare Payment, Phase I: Improving Accuracy pages 2-1 thru 2- 29) and; Recommendation 5-5 CMS and the Bure au of Labor Statisti cs should develop an agreement allowing the Bureau of Labor Statistics to analyze confidential data for the Centers for

Medicare and Medicaid Services . (Geographic Adjustment in Medicare Payment, Phase I: Improving Accuracy pg 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 requires the use of confidential BLS OES da ta, to which CMS does not have access at this time. Although the Institute of Medicine recomm ends 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. We s eek comment on the use of confidential employee wage index data rather than the publicly availa ble all-industry wage data. 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 employee 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 forCMS-1590-P 129

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: Proxies should continue to be used to measure geographic variation in the physician work adjustment, but CMS should determine whether the seven proxies curren tly in use should be modified (Geographic Adjustment in Medicare Payment, Phase I: Improving Accur acy pg 5-36) and; Reco mmendation 5-3: CMS should consider 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 occupati ons and calculating an occ upation-specific index for each proxy; (2) Assigning weights to each proxy-occupati on index based on the each occupation’s share of total national wages to create an aggregate proxy-occ upation index; and (3) Adjusting the aggregate proxy-occupation i ndex by a physician inclusion factor to

calculate 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 proxyCMS-1590-P 130

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 work 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 theCMS-1590-P 131

wage information of proxy occupations to accura tely measure regional variation in physician

wages. We seek comment on the Institute of Medi cine recommendations to revise the work GPCI methodology. In addition, we look forwar d to the MedPAC study on this issue required under section 3004 of the MCTRJCA. This study will assess whether any geographic adjustment to physician work is appropriate and, if so, what the level should be and where it should be applied. (D) Institute of Medicine Recommendation 5-6 : A new source of information should be developed to determine the variation in the pri ce of commercial office re nt per square foot. (Geographic Adjustment in Medicare Payment, Phase I: Improving Accuracy pages 5-38 thru 5- 39)

The Institute of Medicine recommends the 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 Serv ice, Medical Group Management Association (MGMA), and REIS, Inc. The Institute of Medici ne concluded that these sources had substantial limitations, including lack of representativeness of the market in which physicians rent space, small sample size, low response rates, and samp le biases. Although we agree that a suitableCMS-1590-P 132

source for commercial office rent da ta would be preferable to the us e of residential rent data in our PE office rent methodology, we have still been unable to identify an adequate commercial rent source that sufficiently covers rural and urban areas. We will continue to evaluate possible commercial rent data sources for potential use in the office rent calculation. We also encourage public commenters to notify us of any publicly av ailable commercial rent data sources, with adequate data representation of urban and rural areas that could potentially be used in the calculation of the office rent component of PE.CMS-1590-P 133

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 incl ude consultations, office visits, office 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 ruleCMS-1590-P 134

with comment period (66 FR 55246). Section 1834(m)(4)(F)(ii) of th e Act required the Secretary to establish a process th at provides for annual updates to th e list of Medicare 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 originating sites included the office of a practitioner, a crit ical access hospital (CAH), a rural health clinicCMS-1590-P 135

(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 designated 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);CMS-1590-P 136

● 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 under State law to furnish the service via a telecommunications system:

● Physician;

● Physician assistant (PA);

● Nurse practitioner (NP);CMS-1590-P 137

● 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, theCMS-1590-P 138

originating site certifie s that it is located in either a ru ral HPSA or non-MSA county or is an 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 telehealth services as defined under section 1834(m) of the Act. Ra ther, 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 ServicesCMS-1590-P 139

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 submit 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 articlesCMS-1590-P 140

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:

● 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 ofCMS-1590-P 141

1 hour of in-person instruction to ensure eff ective injection training) , 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 next 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 interventionCMS-1590-P 142

(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 services 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 are not proposing to add these CPT codes to the list of Medicare 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 believe 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 betweenCMS-1590-P 143

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 and

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 are proposing to add HC PCS codes G0396 and G0397 to the list of telehealth services for CY 2013 on a category 1 basis. Consistent with this proposal, we are also proposing to revise our regulations at §410.78( b) and §414.65(a)(1) to include alcohol and

substance abuse assessment and intervention se rvices 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 availableCMS-1590-P 144

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:

● 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 HCPCS code G0447 (Face-toface behavioral counseling for obesity, 15 minutes). We believe that the interactions between practitioners and beneficiaries receiving these se rvices are similar to individual KDE services reported by HCPCS code G0420 (Face-to-face educationa l services related to the care of chronic kidney disease; individual, per session, per one hour), individual MNT reported by HCPCS code G0270 (Medical nutrition therapy; reassessment and subsequent intervention(s) following secondCMS-1590-P 145

referral in the same year for change in di agnosis, medical condition or treatment regimen (including additional hours needed for renal dise ase), individual, face-to-face with the patient, each 15 minutes); CPT code 97802 (Medical nutrition therapy; initial assessment and intervention, individual, face- to-face with the pati ent, each 15 minutes); and CPT code 97803 (Medical nutrition ther apy; re-assessment and intervention, in dividual, face-to-face with the patient, each 15 minutes), and HBAI reporte d by CPT code 96150 (Health and behavior assessment (for example, health-focused clin ical interview, behavioral observations, psychophysiological monitoring, health-oriented questionnaires), each 15 minutes face-to-face with the patient; initial assessment); CPT code 96151 (Health and behavior assessment (for example, health-focused clin ical interview, behavioral observations, psychophysiological monitoring, health-oriented questionnaires), each 15 minutes face-to-face with the patient reassessment); CPT code 96152 (Health and behavior intervention, each 15 minutes, face-to-face; Individual); CPT code 96153 (Health and behavi or intervention, each 15 minutes, face-to-face; Group (2 or more patients)); CPT code 96154 (Health and behavior intervention, each 15 minutes, face-to-face; family (with the patient present)), all serv ices that are currently on the

telehealth list. Therefore, we are proposing to add HCPCS codes G0442, G0443, G0444, G0445, G0446, and G0447 to the list of tele health services for CY 2013 on a category 1 basis. We note that all coverage guidelines specific to the servic es would continue to ap ply when these services are furnished via telehealth. For example, wh en the national coverage determination requires

that the service be furnished to beneficiaries in a primary care setting, the 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 detailedCMS-1590-P 146

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 are also proposing to revise our regulations at §410.78(b) and §414.65(a)(1) to include these preventive services as Medicare 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 are proposing to make a technical revision to our regulati on at §414.65(a)(1)(i) to reflect telehealth consultations furnished to emergency departme nt patients in additi on to hospital and SNF inpatients.CMS-1590-P 147

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 services to fee-for-service

Medicare beneficiaries who are in patients or outpatients of a cove red hospital for a 2-year period beginning on January 1, 2000. This section has been amended by section 732 of the Medicare Prescription Drug, Improvement, and Mode rnization 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 Medicare, 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), s ection 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 pathologistCMS-1590-P 148

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 Medicare 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 andCMS-1590-P 149

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 the 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 payment through CY 2011. Subsequent to publication of the CY 2012 PFS final rule with comment pe riod, section 305 of the Temporary Payroll Tax Cut Continuation Act of 2011 extended the pa yment through February 29, 2012 and section 3006

of the Middle Class Tax Relief and Job Crea tion 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 is 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 is superseded by statute fo r six months. To be consistent with the statutory changes andCMS-1590-P 150

our current policy, we are proposing conformi ng changes to §415.130(d) such that we will continue payment under the PFS to independent laboratories furnishing the TC of physician pathology services to fee- for-service Medicare beneficiaries w ho are inpatients or outpatients of a covered hospital on or before June 30, 2012. 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. G. Therapy Services 1. Outpatient Therapy Caps for CY 2013 Section 1833(g) of the Act applies annual, per beneficiary, limita tions (therapy caps) on expenses incurred for outpatient therapy services under Medicare Part B. There is one therapy cap for physical therapy (PT) and speech-langua ge pathology (SLP) services combined and a second separate therapy cap for outpatient occupa tional therapy (OT) services. Although therapy services furnished in an outpatient hospital setting have been exempt from the application of the therapy caps, section 3005(b) of the MCTRJCA amended section 1833(g) of the Act to require therapy services furnished in an outpatient hos pital setting during 2012 be subject to the therapy caps beginning not later than October 1, 2012. The therapy caps amount for CY 2013 will be announced in the CY 2013 PFS final rule with comment period. The annual change in each therapy cap is computed by multiplying the cap amount for CY 2012, which is $1,880, by the MEI for CY 2013, then rounding to the nearest $10. This amount is added to the CY 2012 therapy cap amount to obtain the CY 2013 therapy cap amount. An exceptions process to the therapy caps has been in effect since January 1, 2006 -- originally authorized by section 5107 of the DRA, which amended section 1833(g)(5) of the Act. Since that time, the exceptions process for the therapy caps has been extended throughCMS-1590-P 151

subsequent legislation (MIEA-TRHCA, MMSEA , MIPPA, the Affordable Care Act, MMEA, and TPTCCA). Last amended by section 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, th erapy suppliers and providers us e the KX modifier on claims for services that are over the cap amount. Use of th e KX modifier indicates that the services are reasonable and necessary and that there is documentation of medi cal necessity in the beneficiary’s medical record. Section 3005 of the MCTRJCA also requi res two additional changes to Medicare policies for outpatient therapy services. Section 3005(a)(5) adds a new subparagraph (C) to section 1833(g)(5) of the Act, effective Oc tober 1 through December 31, 2012, that requires application of a manual medical review process (similar to the process used in 2006 for certain therapy cap exceptions) for exceptions to the th erapy caps after expenses incurred for the beneficiary’s therapy services (i ncluding services furnished in a hospital outpatient department) exceed the threshold of $3,700 for the year. As w ith the therapy caps, there are two separate thresholds for the manual medical review process – one threshold of $3,700 for PT and SLP services combined and one threshold of $3,700 for OT services. Requests for exceptions to the therapy caps for services above the thresholds ar e subject to a manual medi cal review process. The applicable amount of expenses incurred for therapy services counted towards these thresholds for the year begins on January 1, 2012. Since the exceptions pro cess is set to expire on December 31, 2012, the requirement for a manual medical review process will also expire

then. Section 3005(c) adds a ne w section 1842(t)(2) to the Act, effective beginning on October 1, 2012, that requires th e National Provider Id entifier (NPI) of the physician (or NPP, where applicable), who periodically reviews the therapy plan of car e, to be reported on the claimCMS-1590-P 152

for therapy services. This reporting requirement applies to all claims for outpatient therapy

services.

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/Background In 2010, more than 7.6 million Medicare bene ficiaries received outpatient therapy services, including physical therapy (PT), o ccupational therapy (OT), and speech-languagepathology (SLP). Medicare payments for thes e services exceeded $5.6 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 beneficiar ies receiving therapy serv ices only increased by 2.9 percent per year. Although a significant num ber of Medicare beneficiaries benefit from therapy services, the rapid growth in Medicare expenditures for th ese services has long been of concern to the Congress and the Agency. To addr ess 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 efforts is useful in understandi ng our proposal for CY

2013. (1) Therapy CapsCMS-1590-P 153

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 outpatient hospitals. Since that time, the Congress has amended the statute se veral times to impose a moratorium on the application of the caps or has re quired us to implement an excep tions process for the caps. The therapy caps have only been in effect without an exceptions process for less than two years. (See the discussion about the therapy cap exceptions pr ocess above.) Almost from the inception of the therapy caps, the Congress and the Agency have been exploring potential alternatives to the therapy caps. (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 when more than on e of these services is furnished in a single session. This reduction applies to nearly 40 therapy services. (For a list of therapy services to which this policy applies, see Addenda H.) Th e Physician Payment and Therapy Relief Act of 2010 (PPTRA) subsequently revised the reduction to 20 percent fo r services furnished in an office setting, leaving the 25 percent reduction in place for services furnished in institutional settings. We adopted this MPPR as part of our directive under sec tion 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 taking into consid eration the expected effi ciencies in direct PE

resources that occur when services are furnished together, this policy resu lts in more appropriateCMS-1590-P 154

payment for therapy services. Although we did not adopt this MPPR policy specifically as an alternative to the therapy caps, paying more appropriately for comb inations of therapy services that are commonly furnished in a single session reduces the number of beneficiaries impacted by the therapy caps in a given year. For more deta ils on the MPPR policy, see section II.C.4. of this proposed rule. (3) Studies Performed A uniform dollar value therapy cap sets a limit on the volume of services furnished unrelated to the specific services furnished or the beneficiary’s condition or needs. One uniform cap does not deter unnecessary care or enc ourage 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 dollar value cap, we have been studying therapy practice patterns and exploring ways to refine payment

for these services as an alternat ive 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." That report incl uded two utilization 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 http://www.cms.gov/TherapyServices/

. Since 2004, we have periodically updated th e utilization analyses and posted other reports on the CMS Website to respond to th e additional BBRA requirements. Subsequent reports highlighted the expected effects of limiting services in various ways and presented plansCMS-1590-P 155

to collect data about beneficiary condition, includi ng functional limitations, using available tools. Through these efforts, we have made progress in identifying the outpatient therapy services that are billed to Medicare, the demographics of the beneficiaries who utilize these services, the types of therapy services furnished, the HCPCS codes us ed to bill the services, the allowed and paid amounts of the services, the provid ers of these services, the stat es in which the services are furnished and the type of practit ioner 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 need ed 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 for collecting such data does not exis t. Diagnosis information is av ailable from Medicare claims. However, we believe that the primary diagnosis on the claim is a poor predictor for the type and duration of therapy services required. Much add itional work is needed to develop an appropriate system for classifying clinical cohorts. A 5-year CMS project titled "Development of Outpatient Therapy Payment Alternatives" (DOTPA) is expected to provide some of this info rmation. The project is now in its final stages of data collection. The purpose of the DOTPA proj ect is to identify a set of measures that we could routinely and reliably collect in support of payment alternatives to the therapy caps. Specifically, the measures being collected are to be assessed in terms of their administrative feasibility and their usefulness in identifying beneficiary need for outpatient therapy services and

the outcomes of those services. A final report is expected duri ng the second half of CY 2013. InCMS-1590-P 156

addition to developing alternatives to the therapy caps, the DOTPA project reflects our interest in value-based purchasing by identifying components of value, namely, beneficiary need and the effectiveness of therapy servic es. Although we expect DOTPA to provide meaningful data and practical information to assist in developing im proved methods of paying for appropriate therapy services, DOTPA will not deliver a standardized measurement instrument for use in outpatient therapy services. Further, it is unlikely that this one project alone will provide adequate information to implement a new payment system for therapy. This study combined with data from a wider group of Medicare beneficiaries w ould enhance our ability to develop alternative payment policy for outpatient therapy services. c. Proposal (1) Overview As required by section 3005(g) of MCTRJCA, we are proposing to implement a claimsbased data collection strategy on January 1, 2013. This claims-based data collection system is designed to gather information on beneficiary function and conditi on, therapy services furnished, and outcomes achieved. This information will assist in reforming the Medicare payment system for outpatient therapy services. By collecting da ta on beneficiary function over an episode of therapy services, we hope to better understand the Medicare beneficiar y population that uses therapy services, how their functi onal limitations change as a result of therapy services, and the relationship between beneficiary functional limitations and furnis hed therapy services over an episode of care. The term “functional limitation” generally encompasses both the terms “activity limitations” and “participation restrictions” as de scribed by the International Classification of Functioning, Disability and Health (IC F). (For information on ICF, see http://www.who.int/classifications/icf/en/ and for specific ICF nomenc lature (including activity limitations and participation restrictions), see http://apps.who.in t/classificati ons/icfbrowser/ .)CMS-1590-P 157

We are proposing to encompass, under this proposal, the Medicare Part B outpatient therapy benefit and PT, OT, and SLP under th e Comprehensive Outpatient Rehabilitation Facilities (CORF) benefit. “Incident to” therapy services furnished by physicians or nonphysician practitioners (NPPs) would also be included. This broad applicability would

include services furnished in hos pitals, critical access hospitals (CAHs), skilled nursing facilities (SNFs), CORFs, rehabilitation agen cies, and home health agencies (when the beneficiary is not under a home health plan of care) and private offices. When used in this section “therapists” m eans all practitioners who furnish outpatient therapy services, including physical therapists , occupational therapists, and speech-language pathologists in private practice and those therap ists who furnish services in the institutional settings, physicians and NPPs (inc luding, physician assistants (PAs), nurse practitioners (NPs), clinical nurse specialists (C NSs), as applicable.) This proposal is based upon an option for clai ms-based data collection that was discussed during the CY 2011 rulemaking (75 FR 40096 through 40100 and 73284 through 73293). This option was developed under a contract with CMS as part of the Short Term Alternatives for Therapy Services (STATS) project. The STATS project provided three options for alternative payment to the therapy caps that could be consid ered in the short-term before completion of the DOTPA project. In developing options, the STATS project drew upon the analytical expertise of

CMS contractors and the clinical expertise of various 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;CMS-1590-P 158

● Introducing additional claims edits regard ing medical necessity, in order to reduce overutilization; and

● Adopting a per-session bundled payment that would vary based on beneficiary characteristics and the complexity of evaluation and treatment services furnished in a session. While we did not propose to adopt any of thes e alternatives at that time, we discussed these three options during the CY 2011 rulemaking and solicited public comments on all aspects of these alternatives, including the potential associ ated benefits or problems, clinical concerns, practitioner administrative burden, consistency w ith other Medicare and private payer payment policies, and claims processing considerations. In general, public commenters on the data collection effort questioned the ability to collect the needed informati on using this type of system. Commenters raised specif ic concerns about the training a nd education of therapists that would be needed prior to implementation. A lthough concerns were e xpressed about claimsbased data reporting, no one questioned the need for data on beneficiary condition and functional limitations. The Congress has now included in section 3005(g) of the MCTRJCA a requirement to implement a claims-based data collection effo rt. While the proposed system is based upon the

data collection alternative di scussed in the CY 2011 PFS rulemaking, it has been modified in response to the comments received on the CY 2011 proposed rule. 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 who have good potential to benefit from the serv ices furnished. Importantly, such a system would not encourage the furnishing of medically unnecessary or excessi ve services. At this time,

the data on Medicare beneficiarie s’ use and benefit from therapy services from which to develop an improved system does not exist. This proposed data collection effort would be the first stepCMS-1590-P 159

towards collecting the data needed for this type of payment reform. Once the initial data have been collected and analyzed, we expect to be ab le to identify gaps in information and determine

what additional data are needed to deve lop a new payment policy. Without a better understanding of the diversity of beneficiaries receiving therapy se rvices and the 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 pol icy. While this claims-based data collection proposal is only the first step in a long -term effort, it is an essential step. We are proposing to require th at claims for therapy servic es include nonpayable G-codes and modifiers. Through the use of these code s and modifiers, we w ould capture data on the beneficiary’s functional limitations (a) at the outset of the therapy episode, (b) at specified points during treatment and (c) at discharge from the out patient therapy episode of care. In addition, the therapist’s projected goal for functional status at the end of treatme nt would be reported on the first claim for services and period ically throughout an episode of care. Specifically, G-codes would be used to identi fy what is being repor ted – current status, goal status or discharge status. Modifiers would indicate the extent of th e severity/complexity of the functional limitation being tracked. The diffe rence between the reported functional status at the start of therapy and projected functional status at the end of th e course of therapy represents the progress the therapist anticipates the be neficiary would make during the course of treatment/episode of care. As the beneficiary progresses through the cour se of treatment, one would expect progress toward the goal established by the therapist. By tracking changes in functional limitati ons throughout the therapy episode and at discharge, we would have information about the furnished therapy services and the outcomes of such services. The ICD-9 diagnosis codes report ed on the claim form wo uld provide information on beneficiary condition.CMS-1590-P 160

Since 2006, we have paid claims for thera py services that exc eed the annual per beneficiary caps when the claims include the KX modifier. The presence of the KX modifier on a therapy claim indicates that th e therapist attests that the serv ices on the claim are medically necessary and that the justification for medical necessity is documented in the beneficiary’s medical record. We propose to apply the addi tional G-code and modifi er reporting requirements to all claims, including claims with the KX m odifier and those subject to any manual medical review process, if such manua l medical review or the KX modi fier were applicable, after December 31, 2012. (See the discussion about therapy caps above.) (2) Proposed Nonpayable G-Codes on Beneficiary Functional Status For the proposed reporting, therapists would report G-codes and modifiers on Medicare claims for outpatient therapy services. Ta ble 17 shows the proposed G-codes and their definitions. (An appropriate status indicator wi ll be assigned to these codes if finalized.) TABLE 17: Proposed Nonpayable G-Codes for Reporting Functi onal Limitations. Functional limitation for primary functional limitation GXXX1 Primary Functional limitati on Current status at initial treatment/episode outset and at reporting intervals GXXX2 Primary Functional limita tion Projected goal status GXXX3 Primary Functional limitation Status at therapy discharge or end of reporting Functional limitation for a secondary functional limitation if one exists GXXX4 Secondary Functional limitation Current status at initial treatment/outset of therapy and at reporting intervals GXXX5 Secondary Functional limitation Projected goal status GXXX6 Secondary Functional limitation Status at therapy discharge or end of reporting Provider attestation that functional reporting not required

GXXX7 Provider confirms functional reporting not required

The proposed claims-based data collection sy stem using G-codes and severity modifiers builds upon current Medicare requirements for th erapy services. Sect ion 410.61 requires that aCMS-1590-P 161

therapy plan of care (POC) be established before treatment begins. This POC must include: the type, amount, frequency, and duration of the PT , OT, SLP services to be furnished to each beneficiary, the diagnosis and the anticipated goals. Sect ion 410.105(c) contains similar requirements for services furnished in the CORF setting. We have long encouraged therapists, through our manual provisions, to express the POC -required goals for each beneficiary in terms

that are measureable and relate to identified functional impairments. See Pub 100-02, Chapter 15, Section 220.1.2. The evaluation and the goals de veloped as part of the POC would be the foundation for the initial reporting under the proposed system. Using the first set of G-codes (GXXX 1, GXXX2, and GXXX3) with appropriate modifiers, the therapist would re port the beneficiary’s primary f unctional limitation or the most clinically relevant functional limitation at the time of the initial therapy evaluation and the

establishment of the POC. In combination wi th appropriate modifier s, these G-codes would describe the current functional limitation ( GXXX1) and the projected goal (GXXX2) for the

functional limitation and the status at the end of a course of therapy (GXXX3). At specified intervals during treatment, claims would also incl ude GXXX1 to show the status at that time and GXXX2 to show the goal, which would not change during therapy, except as described below. At the time the beneficiary is discharged from therapy, the final claim for this episode of care would use GXXX2 to show the goal and GXXX3 to de note status at the end of reporting for this

functional limitation. Therapists frequently use measurement tool s to quantify beneficiary function. The Patient Inquiry by Focus on Therapeutic Outcom es, Inc (FOTO) and the National Outcomes Measurement System (NOMS) by the American Speech-Language-Hearing Association (ASHA) are two such assessment tools in the public domain that can be used to determine a composite or overall score for an assessment of beneficiary fu nction. Therapists could use the score producedCMS-1590-P 162

by such measurement tools, provided they are va lid and reliable, to se lect the appropriate modifier for reporting the beneficiary’s functio nal status. While we support the use of consistent, objective tools to determine benefi ciary functional limitation, for several reasons, at this time we are not endorsing, nor are we proposing to require, use of a particular tool to determine the severity modifier discussed in th e next section. Some t ools are proprietary, and others in the public domain cannot be modified to e xplicitly address this data collection project. Further, this data collection effort spans seve ral therapy disciplines. Requiring a specific

instrument could create burdens fo r therapists that would have to be considered in light of any potential improvement in data accuracy, consiste ncy and appropriateness that such an instrument would generate. We may reconsider this decisi on once we have more experience with claimsbased data collection on beneficiar y function associated with furnis hed therapy services. We are seeking public comment on the use of assessment t ools. In particular, we are interested in feedback regarding the benefits and burdens asso ciated with use of a specific tool to assess beneficiary functional limitations. We request that those favoring a requirement to use a specific tool provide information on the preferred tool and describe why the tool is preferred. 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 experience 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 relevant to a successful outcome for the beneficiary, the one that would yield th e quickest and greatest mobility, or the one that is the greatest priority for the beneficiary. In all cases, this primaryCMS-1590-P 163

functional limitation should reflect the predominan t limitation that the furnished therapy services

are intended to address. To allow for more complete reporting, the second set of G-codes in Table 17 could be used to describe a secondary functional limitatio n, when one exists. Two examples demonstrate the applicability of the s econd set of G-codes. (1) A beneficiary under a PT plan of care is being treated simultaneously for mobility restriction, for example, “walki ng and moving” (including, for example, climbing stairs) due to complications following a total knee replacement and for a “self-care” restriction due to a stabilized and immobilized upper extr emity after a shoulder dislocation. (2) A beneficiary under a SLP plan of car e may be treated simultaneously for both a swallowing dysfunction and a communication im pairment resulting from a stroke. This secondary G-code set is used to report the functional limitation that the therapist considers secondary to the primary one at the outset of a course of therapy. For example, in the first scenario above, the therapist determines the “self-care” to be secondary to the beneficiary’s primary one (“walking and moving”). The th erapist would report th e secondary functional limitation using a current status (GXXX4) al ong with the associated goal ( GXXX5). In some cases, a secondary functional limita tion may not develop or be identified until

after the course of treatment ha s begun. In such situations, th e therapist would begin reporting this secondary set at th e time the functional limita tion is identified. Just as in the example above, the therapist would report GXXX4 and GXXX5. For beneficiaries having more than two f unctional limitations, once the goal for the primary functional limitation has been reached or the beneficiary’s potential to reach the goal has been maximized, the reporting on that functiona l limitation ends and reporting can begin on a new functional limitation. The therapist would use the set of G-codes (and associated modifiers)CMS-1590-P 164

for the primary functional limitation, that is, GXXX1 - GXXX3, to report f unctional status of the beneficiary’s third functional restriction. This process of adding a new functional limitation, for example, for the fourth and the fifth, can continue until therapy ends. Following this process, the set of G-codes that the therapist uses origin ally to report each func tional limitation does not change throughout the episode of care, even though the originally reported secondary functional limitation (reported with GXXX4 through GXXX6 ) may have become the primary one, for clinical purposes, once the goal for the originally reported pr imary functional limitation was reached. The therapist is not expected to change the G-code set used originally to report a particular functional limitation; we believe requiring therapists to do so would be too

burdensome and would confuse the data we ar e collecting for programmatic purposes. We are seeking comment on specific issues regarding reporting data on a secondary limitation. Specifically, we request comment s regarding whether reporting on secondary functional limitations should be requ ired or optional. We would also be interested in information regarding what percentage of Medicare therapy bene ficiaries has more than one functional limitation at the outset of therapy, and for those with multiple functional limitations, what is the average number. We would also be interested in information on the percentage of these functional limitations for which therapists go on to measure, document, and develop related therapy goals. 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 are reflect specific ICF terminology:

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

● Activity Limitations and Pa rticipation Restrictions; and

● Environmental Factors Barriers.CMS-1590-P 165

Each pair contained a G-code to represent the beneficiary’s curre nt functional status and another G-code to represent the benefici ary’s projected goal status. Li ke the G-codes in this proposal,

these G-codes would have been used with modifi ers to reflect the severity/complexity of each

element. This set of G-codes appeared to us to be potentially redundant and confusing since we are using the term functional limitations to be synonymous with the ICF terminology “activity limitations and participation rest rictions.” Requiring separate reporting on three elements would have imposed a burden on therapists without prov iding a meaningful benef it in the value of the data provided. Further, because environmental barriers as discussed in CY 2011 are contextual, we do not believe collecting information on them would contribute to developing an improved payment system or assist with medical review. Since our goal is to develop a system that imposes the minimal additional burden while providing adequate data to accomplish the statutory directive (to assist in reforming the Medicare payment system for outpatient therapy services), we are proposing to require th at just one set of G-codes be used for reporting the primary

functional limitation. We added a second set of G-codes for a secondary functional limitation,

which are identical to those used for the primary functiona l limitation. We are interested in public comment on the whether these propos ed G-codes allow adequate reporting on beneficiary’s functional limitati ons. We would particularly appreciate receiving specific suggestions for any missing elements. (3) Severity/Complexity Modifiers For each functional G-code used on a claim, a modifier would be required to report the severity/complexity for that functional limitation. We propose to adopt a 12- point scale to report the severity or complexity of the functional limitation involve d. The proposed modifiers are

listed in Table 18.CMS-1590-P 166

TABLE 18: Proposed Modifiers 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%

An example of how a therapist would translate data from another assessment tool to this scale may be helpful. In our example, the physic al therapist used the Berg Balance Scale (the long original version) to docum ent the beneficiary’s functional balance restriction and the beneficiary’s test score is 33. (The scores on this test ra nge from 0 – 56. A score below 41 is considered to be at moderate risk of falling.) Once the test is complete d, the therapist maps the beneficiary’s score to our severity modifier scale. To do so, the beneficiary’s score must first be converted to a percentage. A score of 33 on a s cale of 56 would equal 59 percent. To map the percentage from the Berg Balance Scale to the m odifier scale, it must be subtracted from 100, since zero on the Berg Balance Scale reflects 100 percent limitation/disa bility. When 59 percent is subtracted from 100 percent, th e result is 41 percent. This number falling between 40 percent and 49 percent is mapped to the severity modifier of “XF.” As already noted, there are many other vali d and reliable measurement tools that therapists use to quantify func tional limitations. Among these are four assessment tools we discussed in CY 2011 PFS rulemaking – namely, the Activity Measure – Post Acute Care (AMPAC) tool, the FOTO Patient Inquiry, OPTI MAL, and NOMS. We list these tools asCMS-1590-P 167

recommended for use by therapists, though not requi red, in the outpatient therapy IOM provision of the Benefits Policy Manual, Chapter 15, Section 220.3C “Documentation Requirements for Therapy Services.” The scores from these and other measurement tools already in use by therapy disciplines produce numeri cal or percentage scores that can be mapped or crosswalked to the proposed severity modifier scale. The advant age of using an assessmen t tool that yields a composite score, such as NOMS, would be th at only the G-codes for the primary functional limitation would need to be reported even if we required reporting of secondary limitations. In assessing the ability of therapists to provide the required severity information regardless of what assessment tool they use, if any, we considered the comments received on the CY 2011 PFS proposed rule discussion and our prel iminary experience from the DOTPA project. Both indicated that we needed gr eater granularity in our severity scale to more accurately assess changes in functional limitation over the course of therapy. Specifically, most commenters favored the 7-point scale over the 5-point ICF-based scale. They preferred a scale with more severity levels since it would allow the therap ist to document smaller changes that many therapy beneficiaries make towards their goals. For ex ample, the “severe” level of the 5-point scale includes a 45-point spread (fro m 50 - 95 percent) making it difficu lt to document a change or improvement in a beneficiary’s condition whose lim itation being rated falls into this category. Commenters also liked the equal in crements of the 7-point scale.

We believe that neither the five- or seven- point scales are adequa te for this reporting system, and developed a new scal e. The 12-point scale we are proposing is an enhancement of the 7-point scale. It achieves the ability to more accurately capture changes in functional

limitations over the course of tr eatment and is easier to use a nd understand. It addresses the concern of a major association, which supported th e 7-point scale, but su ggested that an even more sensitive rating scale (one with more incr ements) might be necessary to show progress ofCMS-1590-P 168

certain beneficiaries toward their projected goals, particularly thos e beneficiaries with neurological conditions, such as strokes. In additi on, the proposed scale’ s 10-percentage point increments make it easier for therapists to conve rt composite and overall scores from assessment

instruments or other measurement tools to this scale. (4) Adaptation for G-Codes by Select Categories of Functional Limitations The ultimate goal of gathering information on beneficiary function is to have adequate information to develop an alternative paymen t system for therapy services. Although the information that would be collected pursuant to the proposal discussed above would greatly increase our understanding of the therapy services furnished and any progress made as a result of these services, it would leave us far short of the data needed for developing a new payment system. A significant limitation of this proposal is that it would not provide data by type of

functional limitation involved. We have been unable to identify an existing system that categorizes the variety of functional limitations addressed by therapists. Without an existing system that could be used to collect data on specific functional limitations, we could not develop and implement a complete system categorizing all functional limitations within the time period allowed by the statute. However, we could begin to collect data on select categories of functional limitations by adapting the reporting system described above to include some category specific-reporting in addition to the generic reporting. Should we d ecide to use a system with category-specific reporting, we would expect to develop specific nonpayable G-codes for select categories of

functional limitations in the final rule. Under this adap tation, if one of the se lect categories of

functional limitations created de scribes the functional limitation be ing reported, that G-code set would be used to report the cu rrent, projected goal, and discharg e status of the beneficiary. Any functional limitation not identified in this limited G-code set would be reported using theCMS-1590-P 169

generic G-codes previously described. To demonstrate this approach, we have cr eated G-codes that describe the two most frequently reported functional limitations by each of the three therapy disciplines in the DOTPA project. (See Table 19.) When appropriate, thes e G-codes would be used exactly as the generic

ones. TABLE 19: Select Categories of G-Codes 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)CMS-1590-P 170

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

The benefit of having these sel ect G-code sets in addition to the general G-codes is that the data collected could be analyzed by sp ecific diagnoses/conditions and categories of

functional limitations. We believe that in or der to develop an improved payment system for therapy services this type of information is n eeded. Moreover, expansion of these categorical Gcodes to encompass many more cat egories of functional limitations is essential. However, implementing specific G-codes for a select set of functional limitations coul d be a starting point.

An initial data set could allow us to begin collecting the necessary da ta. It would also help us to evaluate how such a system works and make im provements before imposing requirements across

the board. We seek input from therapists on categorie s of functional limitations, such as those

described in this section. We specifically request comments re garding the following questions. 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? (5) Reporting FrequencyCMS-1590-P 171

We propose to require this claims-based repor ting in conjunction with the initial service at the outset of a therapy episode , at established intervals during tr eatment and at discharge. The number of G-codes required on a particular clai m would vary from one to four, depending on the circumstances. Table 20 shows a graphic ex ample of which codes are used for specified reporting. We would note that the example repr esents a therapy episode of care occurring over an extended time period. This example might be typical for a beneficiary receiving therapy for

the late effects of a stroke. We chose to use an example with a much higher than average number of treatment days in order to show a greater variety of reporting scenarios. TABLE 20: ExampleEvaluation/Treatment Day 1Begin Reporting Period #1End Reporting Period #1Begin Reporting Period #2Claim for treatment days5 and 6 in Period #2End Reporting Period #2Begin Reporting Period #3Discharge /End of reporting onPrimary Functional 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 . Under this proposal, the first report ing of G-codes and modifiers would occur when the outpatient therapy episode of care begins. This would typically be the date of service when the therapist furnishes the evaluation a nd develops the required plan of care for the beneficiary. At the outset, the therapist would use the G-codes a nd modifiers to report a currentCMS-1590-P 172

status and a projected goal fo r the primary functional limitati on. If a secondary functional limitation needs to be reported at this time, the same information would be reported using Gcodes and associated modifiers for th e secondary functional limitation.

● Every 10 Treatment Days or 30 Calendar Days, Whichever Is Less . We propose to require that the reporting frequency for G-code s and associated modi fiers be once every 10 treatment days or at least once during each 30 cale ndar days, whichever time period is shorter. 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, typi cally at the evaluation, even when the therapist does not furnish a separately billable procedure in addition to the evaluation for this day, would be considered treatment day one, effectively be ginning the count of treatment days or calendar days for the first reporting period. In calculating the 10 treatment days, a treatment day is defined as a calendar day in which treatment occurs resulting in a billable service. Often a treatment day and a therapy “session” or “visit” may be the same, but the two terms are no t interchangeable. Infrequently, for example, a beneficiary might receive certain se rvices twice a day – these two di fferent sessions (or visits) in the same day are counted as one treatment day).

On the claim for service on the 10 th treatment day or the 30 th calendar day after treatment day one, the therapist would only report GXXX1 and the appropriate modifier to show the beneficiary’s functional status at the end of this reporting pe riod. If also reporting on a secondary functional limitation, GXXX4 and the appropr iate modifier would be included as well. The next reporting period begins on the ne xt treatment day, that is, the time period between the end of one reporting period and the next treatment day does not count towards the 30 calendar day period. On the claim for services furnished on this date, the therapist would report both the G-code and modifier showing the cu rrent functional status at this time along withCMS-1590-P 173

the G-code and modifier reflecti ng the projected goal that was iden tified at the outset of the therapy episode. This process would continue until the beneficiary concludes the course of therapy treatment. On a claim for a service that does not require sp ecific reporting of a G-code with modifier (that is, a claim for services betw een the first and the tenth day of service and that is less than 30 days from the initial assessment), GXXX7 would be used. By using this code, the therapist would be confirming that the claim does not re quire specific functional limitation reporting. This is the only G-code that is reported without a severity modifier. The count of days, both treatment and calenda r, for the second reporting period and any others thereafter, would begin on the first treatment day after th e end of the previous reporting period. We selected the 10/30 frequency of repor ting to be consistent with our 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 these reporting timeframe s consistent with Medicare’s other requirements, therapists, who are already furnishing therapy services to Medicare outpatients, would have a familiar framework for successfully adopting our new repo rting requirement. This should minimize the additional burden. In addition to reflecting th e Medicare required documentation for progress reports, we believe that this simplifies the proc ess and minimizes the new burden on practitioners since many therapy episodes would be completed by the 10 th treatment day. In 2008, the average number of days in a therapy episode was nine tr eatment days for SLP, 11 treatment days for PT, and 12 treatment days for OT. When reporting on two functional limitations, the therapist would report the G-codes and modifiers for the second condition in the manner described above. In other words, at the end of th e reporting period, two G-codes woul d be reported to show currentCMS-1590-P 174

functional status – one for the primary (GXXX1) and one for the secondary (GXXX4) limitation. Similarly, at the beginning of the reporting peri od four G-codes would be reported. GXXX1 and GXXX4 would be used to repor t current status for the prim ary and secondary functional limitations, respectively; and, GXXX 2 and GXXX5 would be used to report the goal status for the primary and secondary functi onal limitations, respectively. The reporting periods must be the same for both the prim ary and secondary functional limitation. 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 reporting period must be re-started by reporting GXXX1 and GXXX2 at the same time the new secondary functional limita tion 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 propose 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 days, whichever time period is less. We believe it is important that the requirem ents for this reporting system be consistent with the requirements for documenting any progre ss in the medical record as specified in our manual. Given the current proposal for claims -based data collection, we believe it is an appropriate time to reassess the manual requir ements. Toward this vein, we are seeking

comment on whether it would be appropriate to modify the progr ess note requirement in the IOM to one based solely on the number of treatment days, such as six or ten. Should this modification be made, a corresponding change would be made in the reporting periods. We seek comments regarding clinical im pact of such a change.

● Discharge. In addition, we are proposing to re quire reporting of the G-code/modifierCMS-1590-P 175

functional data at the conclusion of treatment so that we have a complete set of data for the therapy episode of care. Requi ring the reporting at discharge mi rrors the IOM requirement of a discharge note or summary. This set of data would reve al any functional progress or improvement the beneficiary made toward the pr ojected therapy goal during the entire therapy episode. Specifically, having information on the be neficiary’s functional status at the time of discharge shows whether or to what degr ee the projected therapy goal was met. To report the current status of the functional limitation at the time of discharge, the therapist would use GXXX3 and the appropriate m odifier. Where there is a secondary functional limitation, GXXX6, along with its appropriate modi fier, would also be reported. In addition, GXXX2, along with the modifier es tablished at the outset of ther apy, is used to report the projected goal status of the primary func tional limitation. And, GXX X4 and its corresponding modifier is reported to show th e projected goal status for the s econdary functional limitation that was established at the outset of therapy. The imposition of this reporting requirement does not justify scheduling an additional, 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 lik ely to be incomplete for some beneficiaries receiving outpatie nt therapy 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 an d modifiers at the time therapy e nds. Sometimes, beneficiaries may discontinue therapy without alerti ng their therapist of their inte ntion to do so, simply because they feel better, they can no longe r fit therapy into their work sche dules, or their transportation is

unavailable. Whatever the reas on, there would be situations wh ere the therapy ends without a discharge visit. In these situa tions, we would not require the re porting at discharge. However,CMS-1590-P 176

we encourage therapists to include discharge re porting whenever possible on the final claims. For example, since the therapist is typically reassessing the benefici ary during the therapy sessions, the data critical to the severity/compl exity of the functional measure may be available even when the final therapy session does not oc cur. In these instances, the G-codes and modifiers appropriate to disc harge should be reported. We are particularly interested in how often the therapy community finds that

beneficiaries discontinue therapy without the therapist knowin g in advance that it is the last

treatment session and other situations in which the discharge data would not be available for reporting.

● Significant Change in Beneficiary Condition. We are proposing 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 tr eatment described in the POC. This reporting affords the therapist the opportuni ty to explain a beneficiary’s failure to progress toward the initially established goal(s) and permits either th e revision of the severity status of the existing goal or the establishment of a new goal or goals. The therapist would be required to begin a new reporting period when submitting a claim containi ng a CPT code for an evaluation or a reevaluation. These G-codes, along with the associ ated modifiers, could be used to show an increase in the severity of one or two functional limitations; or, they could be used to reflect the severity of newly identified functional limitations as delineated in the revised plan of care. (6) Documentation We propose to require that documentation of the information used for reporting under this system must be included in the beneficiary’ s medical record. The th erapist would need toCMS-1590-P 177

track in the medical record the G-codes and the corresponding severity modi fiers that were used to report the status of the functional limitations at the outset of the therapy episode, at the beginning and end of each reporting period, and at the time of discha rge (or to report that the projected goal has been achieved and reporting on the particular func tional limitation has ended). It is important to include this information in the record in order to create an auditable record and so that this record would also serve to improve the quality of data CMS collects as it will help the therapist keep track of assessment and treatment information for particular beneficiaries. For example, the therapist selects the func tional limitation of “walking and moving” as the primary limitation and determines that at therapy outset the benefi ciary has a 60 percent limitation and sets the go al to reduce the limitation to 5 pe rcent. The therapist uses GXXX1-XH to report the current status of the functional impairment; and GXXX2-XB to report the goal. The therapist should note in the beneficiary’s me dical record that the functional limitation is “walking and moving” and document the G-codes a nd severity modifiers used to report this functional limitation on the claim for therapy services. (7) Claims Requirements Except for the addition of the proposed G-code s and modifiers, nothing in this proposal would modify other existing requirements for subm ission of therapy claims. For example, the therapy modifiers – GO, GP, and GN – are still re quired to indicate that the therapy services, for

which the G-codes and modifiers are used to re port function on, are furnished under a OT, PT, or SLP plan of care, respectively. Claims from institutional provi ders, which are submitted to the fiscal intermediaries (FIs) and A/B MACs, would require that a charge be included on the service line for each one of these G-codes in the series, GXXX1 - GXXX7. This charge would not be used for payment purposes and would not affect processing. Claims for professional services submitted to carriers and A/BCMS-1590-P 178

MACs do not require that a char ge be included for these nonpa yable G-codes but reporting a charge for the nonpayable G-codes would not affect claims processing. Medicare does not process claims that do not include a billable service. As a result, reporting under this system would need to be included on the same claim as a furnished service

that Medicare covers. (8) Implementation Date In accordance with section 3005(g) of the MCTRJCA, we propose to implement these data reporting requirements on January 1, 2013. We recognize that with electronic health

records and electronic claims su bmission, therapists may encounter 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 are proposing a testing period from January 1, 2013 until July 1, 2013. We would expect that all those billing for outpatient therapy services would take advantage of this testin g period and begin attempting to report the new G-codes and modifiers as quickly as possible on or after January 1, 2013, in preparation for required reporti ng beginning on July 1, 2013. Taking advantage of this testing period would help to minimize potential problem s after July 1, 2013, when claims without the appropriate G-codes and modifi ers would be returned unpaid. (9) Compliance Required as a Condition for Payment and Regulatory Changes To implement the reporting system require d by MCTRJCA and described above we are proposing to amend the regulations establishi ng the conditions for payment governing PT, OT, SLP, and CORFs to add a requirement that th e claims include information on beneficiary functional limitations. In addition, we propose to amend the plan of care 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 cons istent with the benefi ciary function reporting onCMS-1590-P 179

claims for services. Specifically, we propose to amend the regul ations 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 furnished services contai n the information on beneficiary functional

limitations as described in this rule. We also propose to amend the plan of care re quirements 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 requ irement is in addition to those already existing

conditions for the POC To achieve consistency in the provision of PT, OT, and SLP services across settings, we propose to amend §410.105 to include the same requirements for these services furnished in CORFs. These proposed revisions would require that the goal s in the treatment plan be consistent with the beneficiary function reported on claims for services and that claims submitted for furnished services contain specified in formation on beneficiary functional limitations, respectively. Respiratory therapy services furn ished in CORFs are not subject to the reporting requirements, and therefore, these re quirements would not apply to them. (10) 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. We are meeting this requirement through the publication of this proposal, and specifically soli cit public comment on the various aspects of our proposals. In addition, we plan to meet with key stakeholders and will discuss this issue in Open

Door Forums over the course of the summer.CMS-1590-P 180

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 ensure accurate payment for, and encourage long-term investment in, primary care and care manageme nt services. These initiatives include the following programs and demonstrations:

● The Medicare Shared Savings Program (d escribed in ‘‘Medicare Program; Medicare Shared Savings Program: Accountable Care Organi zations; 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 http://innovations.cms.gov/initi atives/ACO/Pioneer/index.html ). ++ The testing of the Advance Payment AC O model, designed to support organizations participating in the Medicare Shared Savings Pr ogram (described on Innovation Center’s website

at http://innovations.cms.gov/initiatives/ACO/Advance-Payment/index.html ).

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

at http://www.cms.gov/Medicare/M edicare-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 pr imary care practices more broadly available. (described on the CMS Website at http://www.cms.gov/Medicare/DemonstrationProjects/DemoProjectsEvalRpts/downloads/mapcpdemo_Factsheet.pdf ). The goal of theCMS-1590-P 181

MAPCP demonstration is to take a multi-payer approach to creating more advanced primary care

services or “medical homes” that utilize a team approach to care, while emphasizing prevention, health information technology, care coordinatio n, and shared decision making. CMS will pay a monthly care management fee for Medicare fee-fo r-service beneficiaries receiving primary care from advanced primary care practices participa ting in the demonstration. The following states are participating in the MAPC P demonstration: Maine, Vermont, Rhode Island, New York, Pennsylvania, North Carolina, Michigan, and Minnesota. 1

● The Federally Qualified Health Center (FQHC) Advanced Primary Care Practice demonstration (described on the CMS Website at http://www.cms.gov/Medicare/DemonstrationProjects/DemoProjectsEvalRpts/downloads/mapcpdemo_Factsheet.pdf and Innovation Center’s

website at http://innovations.cms.gov/in itiatives/FQHCs/index.html ). Participating FQHCs in the demonstration are expected to achieve Nati onal Committee for Quality Assurance (NCQA) Level 3 Patient-Centered Medical Home recogniti on by the end of the dem onstration as well as help patients manage chronic conditions and ac tively coordinate care for patients. To help participating FQHCs make the needed investment s in patient care and infrastructure, CMS is paying a monthly care management fee for each eligible Medicare fee-for-service beneficiary receiving primary care services . In addition, both CMS and th e Health Resources Services Administration (HRSA) are prov iding technical assistance to FQHCs participating in the

demonstration.

● The Comprehensive Primary Care (CPC ) initiative (described on the Innovation

Center’s website at http://innovations.cms.gov/initiativ es/Comprehensive-Primary-CareInitiative/index.html ). The CPC initiative is a multi-payer initiative fostering collaboration between public and private health care payers to strengthen primary care in the following

1 More information about the MAPCP demonstration is available at http://www.cms.gov/Medicare/DemonstrationProjects/DemoProjectsEvalRpts/Medicare-De monstrations-Items/CMS1230016.html.CMS-1590-P 182

markets: Arkansas, Colorado, New Jersey, New York in the Capital-District-Hudson Valley Region, Ohio and Kentucky in the Cincinnati-D ayton Region, Oklahoma in the Greater Tulsa Region, and Oregon. CMS pays a monthly care management f ee to selected primary care practices on behalf of their f ee-for-service Medicare beneficiar ies and in years 2-4 of the initiative, each practice has the potential to share in savings to the Medicare program. 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. The annual PFS notice and comment rulemaking process provides an important avenue for interested parties to provi de input on discrete proposals in tended to achieve these goals. Should any of these discrete proposals become fina l policy, we would expect many of them to be short-term payment strategies that would be modi fied and/or revised to be consistent with broader primary care and care management and coor dination services if th e agency decides to pursue payment for a broader set of management and coordination services in future rulemaking. 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 disease. We also proposed to review evaluation andCMS-1590-P 183

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 disease management and care coordination as key reason for undertaking this

review. In the CY 2012 PFS final rule with comm ent period, we did not fi nalize our proposal to

review E/M codes due to consensus from an overw helming majority of co mmenters that a review of E/M services using our current processes coul d not appropriately valu e the evolving practice of chronic care coordination, and therefore, would not accomplish the agency’s goal of paying appropriately for primary care services. We stat ed that we would continue to consider ongoing research projects, demonstrations, and th e numerous policy alternatives suggested by commenters. In addition, in the CY 2012 PFS proposed rule (76 FR 42917 through 42920), we initiated a public discussion rega rding payments for post-discharge care management services. We sought broad public comment on how to further improve care management for a beneficiary’s transition from the hospital to the community setting within the existing statutory structure for physician payment and quality re porting. We specifically discussed how post discharge care management services are c oded and valued under the current E/M coding structure, and we reque sted public comment. The physician community responded that comp rehensive care coordination services are not adequately represented in the descriptions of, or paymen ts for, office/outpatient E/M

services. The American Medical Association (AMA) and the American Academy of Family Physicians (AAFP) created workgroups to cons ider new options for coding and payment for primary care services. The AAFP Task Force re commended that CMS create new primary care E/M codes and pay separately for non-face-to-f ace E/M Current Procedural Terminology (CPT) codes. (A summary of these re commendations is available at http://www.aafp.org/online/en/home/publ ications/news/news-now/inside-CMS-1590-P 184

aafp/20120314cmsrecommendations.html .) The AMA workgroup, Chr onic Care Coordination Workgroup (C3W), is developing codes to desc ribe care transition and care coordination activities. (Several workgroup meeting minutes and other related items are available at http://www.ama-assn.org/ama/pub/physicia n-resources/solutions-managing-yourpractice/coding-billing-insuranc e/medicare/care-coordination.page ) We are continuing to monitor the progress of this workgroup and look forward to receiving its final recommendations. For this CY 2013 PFS proposed rule, we have decide d to proceed with a proposal to refine PFS payment for post discharge care management servi ces. We also include a discussion of how we could incorporate the idea of advanced primary care through pr actices certified as medical homes in the FFS setting. In developing the proposal and discussion described below, we have thoroughly considered documented concerns re garding Medicare payment for non-face-to-face

elements of E/M services that are crucial to ca re coordination. We will continue to consider other enhancements to payment for primary care services and complex chronic care coordination services, and we may make further proposals to improve payment mechanisms and foster quality

care for these and similar serv ices in future rulemaking. 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 providing 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 hospitalCMS-1590-P 185

discharge day management (CPT codes 99238 and 99239), which include providing care coordination, communication, and other necessary management related to the hospitalization in the post-service work. As we have indicated many times in prior rulemaking, the payment for non-face-to-face care management services is bundled into the pa yment for face-to-face E/ M visits. Moreover, Medicare does not pay for servi ces that are furnished to partie s other than the beneficiary and which Medicare does not cover, for example, co mmunication with caregiver s. Accordingly, we do not pay separately for CPT codes for tele phone calls, medical team conferences, prolonged services without patient contact, or anticoagulation management services. However, we continue to hear concerns from the physician community that the care coordination included in many of the E/M services , such as office visits, does not adequately describe the non-face-to-face care management work involved in primary care. Because the current E/M office/outpatient visi t CPT codes were designed to support all office visits and

reflect an overall orientation to ward episodic treatment, we agr ee that these E/M codes may not reflect all the services and resources required to furnish comprehensive, coordinated care management for certain categories of benefici aries such as those who are returning to a community setting following discharge from a hospital or SNF stay. We are therefore considering new options to recognize the additio nal resources typically involved in furnishing coordinated care to particular types of beneficiaries. As described below, we are proposing to a ddress the significant non-face-to-face work involved in coordinating services for a beneficiary after discha rge from a hospital or skilled nursing facility (SNF). Specifically, we propose to create a HCPCS G-code to describe care management involving the transiti on of a beneficiary from care furnished by a treating physician during a hospital stay (inpatie nt, outpatient observation serv ices, or outpatient partialCMS-1590-P 186

hospitalization), SNF stay, or community mental health center (CMHC) partial hospitalization program to care furnished by the beneficiary’ s primary physician in the community. We consider this proposal to be part of a multip le year strategy exploring the best means to encourage care coordination se rvices. Furthermore, in th e interest of encouraging comprehensive primary care services furnished in advanced primary care practices, we have included a discussion regarding how care furnished in these settings might be incorporated into

the current fee-for-service structure of the PFS We look forward to continued development of these ideas through current research and demons tration projects, experience with ACOs and other programs, and furthe r discourse on these issues with stakeholders. 1. Hospital, SNF, or CMHC Post -Discharge Care Management a. Background Care management involving the transition of a beneficiary from care furnished by a treating physician during a hospita l, SNF, or CMHC stay to th e beneficiary’s primary physician in the community can avoid adverse events such as readmissions or subsequent illnesses, improve beneficiary outcomes, and avoid a fi nancial burden on the health care system. Successful efforts to improve hospital discharg e care management and care transitions could improve the quality of care while si multaneously decreasing costs. Currently, there are several agency initiativ es aimed at hospital and community-based organizations. In April 2011, HHS launched the Partnership for Patients, a national publicprivate patient safety initiative for which more than 6,000 organizations—including physician and nurses’ organizations, cons umer groups, employers and over 3,000 hospitals—have pledged to help achieve the Partnership’s goals of re ducing hospital complicati ons and improving care transitions. (More information on this initiative is available at http://innovations.cms.gov/initiatives/p artnership-for-patients/index.html .) The Partnership forCMS-1590-P 187

Patients includes the Community-based Care Tran sitions Program, created by section 3026 of the Affordable Care Act, which provides funding to community-based organizations partnering with eligible hospitals to coordinate a continuum of post-acute care to test models for improving care transitions for high risk Me dicare beneficiaries. Section 1886(q) of the Act (as added by sect ion 3025 of the Affordable Care Act) directs the Secretary to establish a Hospital Readmissions Reductio n Program, beginning in FY 2013, for certain potentially preventable Medicare inpatient hospital readmissions covering three conditions: heart attack; pneumoni a; and congestive heart failure. Beginning in FY 2015, the number of applicable conditions can be expanded beyond the initia l three conditions. Under this program, a portion of Medicare’s payment amounts for inpatient services to certain hospitals will be reduced by an adjustment factor based the hospital’s excess Medicare readmissions. In the FY 2012 IPPS final rule (76 FR 51662-51676), we provided an overview of the Hospital Readmission Reduction program and finalized po licies regarding selection of applicable conditions, definition of “readmissions,” measures of the applicable conditions chosen for readmissions, methodology for calculating the ex cess readmissions ratio, public reporting of readmission data, and definition of applicable period. In the FY 2013 IPPS proposed rule (77 FR 27955-27968), we made proposals regarding the base operating DRG payment amount, the adjustment factor, aggregate payments for excess readmissions, and the ho spitals that would be included in the program. In its 2007 Report to Congress: Promoting Gr eater Efficiency in Medicare, MedPAC found that, in 2005, 17.6 percent of admissions re sulted in readmissions within 30 days of discharge, accounting for $15 billion in spending . MedPAC estimated th at 76 percent of the 30 day readmissions were potentially preventable, re sulting in $12 billion in spending. In the same report, MedPAC also found that the rate of potentially avoi dable rehospitalizations afterCMS-1590-P 188

discharges from skilled nursing facilities was 17. 5 percent in 2004 (an increase of 2.8 percentage points from 2000.) MedPAC noted: “We focus on th e hospital’s role but recognize that other types of providers, including physicians and various post-acute care providers, can be instrumental in avoiding read missions...[C]ommunity physicians and post-acute care providers receiving the patient may not be sufficiently informed about the patient’s care needs and history

to enable effective care.” We agree with MedPAC that primary care physicians and practitioners play a key role in post-acute care and reducing hospital readmissions. In the CY 2012 PFS proposed rule (76 FR 42917 through 42920), we initiated a public discussion regarding payments for post-discharge care coordination services . We sought broad public comment on how to further improve physic ian care coordination w ithin the statutory structure for physician payment and quality repor ting, particularly for a beneficiary’s transition from the hospital to the community. As noted ab ove, we also proposed to review E/M services as potentially misvalued and s uggested that the AMA RUC might consider chronic disease management and care coordination in its review (76 FR 42793). While the commenters agreed

that care coordination would lead to better care for beneficiarie s, they believed this care would be better described by new codes, and not the current E/M codes. b. Hospital and SNF Discharge Services

We believe that the successful transition of a beneficiary from care furnished by a hospitalist physician to care furnished by the beneficiary’s primary physician or qualified nonphysician practitioner could avoi d adverse events such as readmissions or subsequent illnesses, improve beneficiary outcomes, and avoid a financial burden on the health care system. We also believe that the current hospital discharge management codes (CPT codes 99238 and 99239) and nursing facility discharge services (CPT c odes 99315 and 99316) adequately capture the care coordination services required to discharge a beneficiary fr om hospital or skilledCMS-1590-P 189

nursing facility care. The work relative values for those discharge management services include a number of pre-, post-, and intr a-care coordination activities. For example, the hospital discharge management codes include the followi ng pre-, intra-, and post- service activities relating to care coordination:

Pre-service care coordination activities include:

● Communicate with other professionals a nd with patient or patient's family.

Intra-service care coordination activities include:

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

● Provide care coordination for the transi tion including instructions for aftercare to caregivers;

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

● Inform the primary care or referring physician or qualified nonphysician 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.

Because these activities are critical to successfully avoiding readmissions, we seek comment about the best ways to ensure that al l the activities of the di scharge day management codes for hospital and nursing f acility discharge, including the care coordination activities, are understood and furnished by the physicians or qu alified nonphysician practitioners who bill for these services. Potential ways could include physician education or MEDLEARN articles.CMS-1590-P 190

c. Defining Post-Discharge Transi tional Care Management Services

While we believe that current hospital and nursing facility discharge management service codes adequately capture the care management ac tivities involved with discharging a beneficiary from a hospital or skilled nursing facility, we do not believe that current E/M office or other outpatient visit CPT codes appropriately descri be comparable care management work of the community physician or qualified nonphysician pract itioner coordinating car e for the beneficiary post-discharge. This is because the E/M codes represent the typical outpatient office visit and do not capture or reflect the significant care coordinati on activities that need to occur when a patient transitions from institutional to community-based care. We believe that the work of the discharging physician or qualif ied nonphysician practitioner should be complemented by corresponding work of a receiving physician or qualified nonphysician practitioner in the community in order to ensure better continuity of care through establishing or revising a plan of care for the beneficiary after di scharge. We acknowledge that many, if not most, physicians or qualified nonphysician practitioners caring for be neficiaries following a hospital or nursing facility discharge have been furnishing coordi nated care and reporting o ffice or other outpatient CPT codes. However, we agree with commenter s to the CY 2012 proposed and final rules that the services described by cu rrent E/M office or other outpatient CPT codes 99201 through 99215 may not appropriately capture th e significant coordination servi ces involved in post-discharge

care. We are proposing to create a HCPCS G-code that specifica lly describes post-discharge transitional care management services. The c ode would describe all non-face-to-face services

related to the transitional car e management 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 hos pital, long-term care hos pital, skilled nursingCMS-1590-P 191

facility, and inpatient rehabilitation facility; hosp ital outpatient for observa tion services or partial hospitalization services; and a partial hospitaliz ation program at a CMHC to community-based care. The post-discharge transitional care mana gement service includes non-face-to-face care management services furnished by clinical st aff member(s) or office-based case manager(s) under the supervision of the community physician or qualified nonphysician practitioner. We use the term community physician and pr actitioner in this discussion to refer to the community-based physician managing and coordinatin g a beneficiary’s care in th e post-discharge period. We anticipate that most community physicians will be primary care physicians and practitioners. We have based the concept of this proposal, in part , on our policy for care plan oversight services. We currently pay physicians for the non face-to-f ace care plan oversight services furnished for patients under care of home health agencies or hospices. These patients require complex and multidisciplinary care modalities that involve: re gular physician development and/or revision of care plans, subsequent reports of patient stat us, review of laborator y and other studies, communication with other health professionals not employed in the same practice who are involved in the patient’s care, integration of new information into the care plan, and/or adjustment of medical therapy. Physicians providing these services bill HCPCS codes G0181 (Physician supervision of a patient receiving Medicare-cove red services provided by a participating home health agency (patient not present) requiring complex and multidisciplinary care modalities involving regular ph ysician development and/or revi sion of care plans, review of subsequent reports of patient status, review of laboratory and other studies, communication (including telephone calls) with other health care professionals involved in the patient’s care, integration of new information into the medical treatment plan and/or adjustment of medical therapy, within a calendar month, 30 minutes or more), or G0182 (Physician supervision of a patient under a Medicare-approved hospice (pat ient not present) requiring complex andCMS-1590-P 192

multidisciplinary care modalities involving regul ar physician development and/or revision of care plans, review of subsequent reports of pati ent status, review of la boratory and other studies, communication (including telephone calls) with other he alth care professionals involved in the patient’s care, integration of new information into the medical treatment plan and/or adjustment of medical therapy, within a ca lendar month, 30 minutes or more). (See the Medicare benefit manual, 100-02, Chapter 15,Section 30 for de tailed description of these services.) For CY 2013, we are proposing to create a new code to describe post-discharge transitional care management. Th is service would 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 diagnostic test results, including each of the following tasks: ++ An assessment of the patient’s or car egiver’s understandi ng of the medicationCMS-1590-P 193

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 would

also 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 post-discharge transitional care services HCPCS G-code we are proposing would be used by the community physician or qualified no nphysician practitioner to report 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 qualifiedCMS-1590-P 194

nonphysician practitioner and complement the E/ M office/outpatient visit CPT codes. The post-discharge transitional care servic e would support the patient’s physical and psychosocial health. In our recent Decisi on Memorandum for Screening for Depression in Adults, CAG-00425N, we noted that depression in ol der adults occurs in a complex psychosocial and medical context and that, currently, we belie ve opportunities are missed to improve mental health and general medical outcomes when mental illness is under-recogni zed and undertreated in primary care settings. We wish to emphasi ze the equal importance of the patient’s mental health to the patient’s physical condition to successful re-entry into the community. We propose that the post-discharge transiti onal care service HCPCS G-code would be used to report physician or qualifying nonphysicia n practitioner services for a patient who’s medical and/or psychosocial problems require mo derate or high complexity medical decision making during transitions in care from hospital (i npatient stay, outpatient observation, and partial hospitalization), SNF stay, or CMHC settings to community-based care. Moderate and high complexity medical decision making are defined in the Evaluation and Management Guidelines. In general, moderate complexity medical d ecision-making includes multiple diagnoses or management options, moderate complexity and am ount of data to be review, a moderate amount and/or complexity of data to be reviewed; a nd a moderate risk of si gnificant complications, morbidity, and/or mortality. High complexity de cision-making includes an extensive number of diagnoses or management options, an extensiv e amount and/or complexity of data to be reviewed, and high risk of significant complicatio ns, morbidity, and/or mortality (See Evaluation and Management Services Guide, Centers for Medicare & Medicaid Services, December 2010.) We propose that the post-discharge transitional care HCPCS code (GXXX 1) would be payable only once in the 30 days following a discharge, per patient per discharge, to a single community physician or qualified nonphysician practitioner (or group practice) who assumes responsibilityCMS-1590-P 195

for the patient’s post-discharge transitional care management. The serv ice would be billable only at 30 days post discharge or thereafter. Th e post-discharge transitional care management

service would be distinct from services furnished by the disc harging physician or qualified nonphysician practitioner reporti ng CPT codes 99238 (Hospital discharge day management, 30 minutes or less); 99239 (Hospital discharge da y management, more than 30 minutes) ; 99217 (Observation care discharge day management); or Observation or Inpatient Care services, CPT codes 99234 -99236; as appropriate. We propose to pay the first claim that we r eceive for the beneficiary at 30 days after discharge. Given the elements of the service and the short wi ndow of time following a discharge during which a physician or qualifying nonphysician practitioner will need to perform several tasks on behalf of a beneficiary, we believe it is unlikely that 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 transitional care manage ment services listed above. Ther efore, we do not believe it is necessary to take further steps to identify a beneficiary’s community physician or qualified nonphysician practitioner who furn ishes the post-discharge tran sitional care management services. We propose to pay only one claim fo r the post-discharge transitional care GXXX1 billed per beneficiary at the conclusion of th e 30 day post-discharge pe riod. Post-discharge transitional care management relating to any subse quent discharges for a beneficiary in the same 30-day period would be included in the single paym ent. Practitioners billing this post-discharge transitional care code accept responsibility for ma naging and coordinating th e beneficiary’s care over the first 30 days after disc harge. Although we currently e nvision billing happening as it does for most services, after th e conclusion of the service, we welcome comment on whether in this case there would be merit to allowing billi ng for the code to occur at the time the plan ofCMS-1590-P 196

care is established. We have explicitly constructed this propos al as a payment for non face-to-face postdischarge transitional care manage ment services separate from pa yment for E/M or other medical visits. However, we believe that it is impor tant to ensure that the community physician or qualified nonphysician practitioner fu rnishing post-discharge transi tional care management either

have or establish a relationshi p with the patient. As such, we propose that the community physician or qualified nonphysician practitioner reporting post-discharge transitional care management GXXX1 should already have a relati onship with the beneficiary, or establish one soon after discharge, prior to furnishing transitio nal care management and billing this code. Therefore, we propose that the community phys ician or qualified nonphysician practitioner reporting a transitional care manage ment HCPCS G-code must have billed an E/M visit for that patient within 30 days prior to th e hospital discharge (the start of post-discharge transitional care management period), or must conduct an E/M offi ce/outpatient visit (992 01 to 99215) within the first 14 days of the 30-day post-di scharge period of transitional ca re management services. The E/M visit would be separately billed. While we are proposing that the post-discharg e transitional care management code would not include a face-to-face visit, and that physicia ns or qualified nonphysician practitioners would bill and be paid for this care management service separately from a medical visit, we are seeking comments about whether we should require a fa ce-to-face visit when billing for the postdischarge transitional care mana gement service. We are also seeking comments regarding how we might incorporate such a re quired visit on the same day into the payment for the proposed code. We considered several reasons for requi ring a face-to-face visit on the same day. We wondered whether, with a face-to -face visit immediately after disc harge, the plan of care would be more accurate given that the patient’s medi cal or psychosocial condition may have changedCMS-1590-P 197

from the time the practitioner last met with the pa tient and the practitioner could better develop a plan of care through an in-pers on visit and discussion. We also wondered whether beneficiaries would understand their coinsurance liability for th e post-discharge transitional care service when they did not visit the physician’s or qualified nonphysician practitioner’s office. On the other hand, we have contemplated several scenarios where it is not possible for a beneficiary to get to the physician’s or qualified nonphysic ian practitioner’s office a nd welcome comment on whether an exception process would be appropriate if we were to finalize a same day face-to-face visit as a requirement for billing the post-discharg e transitional care management code. The proposed post-discharge transitional care HCPCS G-code woul d be described as

follows: GXXX1 Post-discharge transitional care management with the following required elements:

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

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

• To be eligible to bill the service, physic ians or qualified n onphysician 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. We contemplated establishing a requirement that post-discharge transitional care management be furnished by a physician or qualified nonphysician practitioner or other cl inical staff in the practice who are qualified to as sist beneficiaries in managi ng post-transition changes in conditions and treatments. We welcome pub lic comment on whether this would be an appropriate requirement for GXXX1. We propose that a physician or qualifie d nonphysician practitioner who bills forCMS-1590-P 198

discharge management during the time period covered by the transitional care management services code may not also bill for HCPCS code GXXX1. The CPT discharge management codes are 99217, 99234-99236, 99238-99239, 99281-99285, or 99315-99316, home health care plan oversight services (HCPCS code G0181), or hospice care plan oversight services (HCPCS code G0182) . We believe 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 transitional care mana gement service. Further, we propose that a physician or qualified nonphysician practitioner billing for a pro cedure with a 10- or 90-day global period would not also bill HCPCS code GXXX1 in conjunction with that procedure because any follow-up care management would be included in the post-operative portion of the global period. Many of the globa l surgical packages include di scharge management codes. We believe that any physician or qualified nonphysic ian practitioner billing separately for the discharge management code that also is th e community physician or nonphysician practitioner for the beneficiary would be paid for post-disc harge transitional care management through the discharge management code. We are making this proposal to provide a separate reporting mechanism to the community physician for these services in the context of the broader HHS and CMS multi-year strategy to recognize and suppor t primary care and care management. Should any of these discrete proposals, like this one , become final policy, they may be short-term payment strategies

that would be modified and/or revised to be consistent with broade r primary care and care management and coordination services if the agen cy decides to pursue payment for a broader set of management and coordination services in futu re rulemaking. We would also note that this proposal dovetails with our disc ussion under section III. J. of this proposed rule on the Valuebased Payment Modifier and Physician Feedb ack Reporting Program which discusses hospitalCMS-1590-P 199

admission measures and a readmission measure as outcome measures for the proposed valuebased payment modifier adjustment beginning in CY 2105. c. Proposed Payment for Post-Discharge Transitional Care Management Service To establish a physician work relative value unit (RVU) for the proposed post-discharge transitional care management, HCPCS code GXXX1, we compared GXXX1 with CPT code 99238 (Hospital discharge day management; 30 minutes or less) (work RVU = 1.28). We recognize that, unlike CPT code 99238, HCPCS code GXXX1 is not a face-to-face visit. However, we believe that the physician time and intensity involved in post-discharge community care management is most equivalent to CP T code 99238 which, like the proposed new G-code, involves a significant number of care management services. Ther efore, we are proposing a work

RVU of 1.28 for HCPCS code GXXX1 for CY 2013. We also are proposing the following physician times: 8 minutes pre-evaluation; 20 mi nutes intra-service; an d 10 minutes immediate post-service. The physician time file associated with this PFS pr oposed rule is available on the

CMS Website in the Downloads section for the CY 2013 PFS proposed rule at http://www.cms.gov/PhysicianFeeSched/

. In addition, we are proposing to crosswalk the clinical labor i nputs from CPT code 99214 (Level 4 established pati ent office or other outpatient visit) to the post-discharge transitional care code. The propos ed CY 2013 direct PE input data base reflects these inputs and is available on the CMS Website under the suppo rting data files for the CY 2013 PFS proposed rule with comment period at http://www.cms.gov/PhysicianFeeSched/ . The proposed PE RVUs included in Addendum B to this pr oposed rule reflect the RVUs th at result from application of this proposal. For malpractice expense, we are proposi ng a malpractice crosswalk of CPT code 99214

for HCPCS code GXXX1 for CY 2013. We believe the malpractice risk factor for CPT codeCMS-1590-P 200

99214 appropriately reflects the rela tive malpractice risk associated with furnishing HCPCS code GXXX1. The malpractice RVUs included in Ad dendum B to this proposed rule reflect the RVUs that result from the appl ication of this proposal. We note that as with other services pa id under the PFS the 20 percent beneficiary coinsurance would apply to the pos t-discharge transitional care ma nagement service as would the

Part B deductible. For BN calculations, we estimated that physic ians or qualified nonphysician practitioners would provide post-discharge transitional care management services for 10 million discharges in CY 2013. This number roughly considers the to tal number of hospital inpatient and SNF discharges, hospital outpatient obs ervation services and partial hos pitalization patients that may require with moderate to high complexity decision-making. For purposes of the Primary Care Incentive Payment Program (PCIP), we are proposing to exclude the post discharge transitional care management services from the total allowed charges used in the denominator calculation to determine whether a physician is a primary care practitioner. Under section 1833( x) of the statute the PCIP pr ovides a 10 percent incentive payment for primary care services within a specif ic range of E/M services when furnished by a primary care practitioner. Specific physician sp ecialties and qualified nonphysician practitioners can qualify as primary care practitioners if 60 percent 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, in order to avoid in advertently disqualifying community primary care physicians who follow their patients into the hosp ital setting, we finaliz ed 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 pr imary care percentage calculation.CMS-1590-P 201

We believe that the proposed transitional care management c ode should be treated in the same manner as those services for the purposes of PCIP because post-discharge transitional care management services are a complement in the co mmunity setting to the hospital-based discharge day management services already excluded from the PCIP denominator. Similar to the codes already excluded from the PCIP denominator, we are concerned that inclus ion of the transitional care management code in the denominator of the primary care percen tage calculation could produce unwarranted bias agains t “true primary care practiti oners” who are involved in furnishing post-discharge care to their patient s. Therefore, while physicians and qualified nonphysician practitioners who furn ish transitional care manage ment would not receive an additional incentive payment under the PCIP for the service itself (because it is not considered a “primary care service” for purposes of the PCIP ), the allowed charges for transitional care management would not be included 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. 2. Primary Care Services Furnished in Advanced Primary Care Practices a. Background As we have discussed above, we are committed to considering new options and developing future proposals for payment of prim ary care services under th e MPFS. Such options would promote comprehensive and continuous as sessment, care management, and attention to preventive services that constitute effective primary care by establis hing appropriate payment when physicians furnish such services. One me thod for ensuring that any targeted payment for primary care services would constitute a mini mum level of care coordination and continuous assessment under the MPFS would be to pay physicia ns for services furnished in an “advanced primary care practice” that has implemented a medical home model supporting patient-specificCMS-1590-P 202

care. The medical home model has been the subj ect of extensive study in medical literature. Since 2007, the AMA, American Academy of Family Physicians (AAFP), the American Academy of Pediatrics (AAP), the American Co llege of Physicians (ACP), and the American Osteopathic Association (AOA), and many other physician organi zations have also endorsed “Joint Principles of the Patient-Centered Medi cal Home.” In February 2011, the AAFP, the AAP, the ACP, and AOA also published formal “Guidelines for Patie nt-Centered Medical Home (PCMH) Recognition and A ccreditation Programs” to deve lop and promote the concept and practice of the PCMH. (The se guidelines are available at http://www.aafp.org/online/etc/me dialib/aafp_org/documents/membership/pcmh/pcmhtools/pcm hguidelines.Par.0001.File.dat/GuidelinesP CMHRecognitionAccreditationPrograms.pdf .) As we have discussed above, the Innovation Center ha s been conducting a severa l initiatives based on the medical home concept. The medical home concept emphasizes establ ishing an extensive in frastructure 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 prac tice transformation under the CPC initiative. We believe these five “comprehensive primary care functions” provid e an appropriate starting point for discussing the incorporation of the comprehe nsive primary care services deliv ered in advanced primary care practices (practices implementing a medical home model) into the MPFS: 1. Risk-stratified Care ManagementCMS-1590-P 203

One of the hallmarks of comprehensive prim ary care is the provision of intensive care management for high-risk, high-need, high-cost patients. Providers must provide routine, systematic assessment of all patients to identif y and predict which patients need additional

interventions. In consultation with their patients, they should create a plan of care to assure care that is provided is congruent with patient c hoices and values. Once patient needs, including social needs and functional deficits, have b een identified, they shoul d be systematically addressed. Markers of success include policie s and procedures describing routine risk assessment and the presence of appropriate ca re plans informed by the risk assessment. 2. Access and Continuity Health providers who know the patient shoul d be accessible when a patient needs care. Providers must have access to patie nt data even when the office is closed so they can continue to participate in care decisions with their patients. Patients need access to the patient care team 24/7. Every patient is assigned to a designated provider or care team with whom they are able to get successive appointments. Markers of success include care continuity and availability of the

EHR when the office is closed.

3. Planned Care for Chronic Conditions and Preventive Care Primary care must be proactive. Practitioners must systematically assess all patients to determine his or her needs (one way w ould be through the an nual wellness visit 2 ) and provide proactive, appropriate care based on that a ssessment. Pharmaceutical management, including

medication reconciliation and revi ew of adherence and potential in teractions, and oversight of patient self-management of medi cations for diabetes, anti-coagul ation management or warfarin therapy, and other chronic conditi ons, should be a routine part of all patient assessments. Markers of success include completion of th e Annual Wellness Visit and documentation of

2 The Affordable Care Act (ACA) covered an annual wellness visit for Medicare beneficiaries through which they are to receive a personalized prevention plan. The ACA al so ensured preventive services would be covered without cost if they are recommended by the US Preventive Se rvices Taskforce and meet certain other conditions.CMS-1590-P 204

medication reconciliation. 4. Patient and Caregiver Engagement Truly patient-centered care assumes the ma ntra “nothing about me without me.” Providers should establish system s of care that include the pati ent in goal setting and decision making, creating opportunities for patient engage ment throughout the care delivery process. Markers of success include policie s and procedures designed to en sure that patient preferences are sought and incorporated in to treatment decisions.

5. Coordination of Care acr oss the Medical Neighborhood The “medical neighborhood” is the totality of providers, re lated non-health services and patients in an area, and the ways in which they work together. 3 Primary care can be seen as the hub of the neighborhood and must take the lead in coordinating care. In particular, primary care providers must move towards leadership of heal th teams both within and outside their practice’s walls. Providers must have the ability to acce ss a single medical record shared by the whole team; the content of this record can be leve raged to manage communication and information flow in support of referrals to other clinicians, and to support safe and e ffective transitions from the hospital and skilled nursing facilities back to the community. The primary care practice must also include personnel who are qua lified to assist patients to ma nage post transition changes in conditions and treatments required to support patients’ health and reduce their need for

readmission. Markers of success include the presence of standard processes and documents for communicating key information dur ing care transitions or upon re ferral to other providers. b. Advanced Primary Care Practices Accreditation and Infrastructure 1. Accreditation Utilizing Nationa lly Recognized Organizations

In the event that we were to establish an enhanced payment for primary care services

3 “Coordinating Care in the Medical Neighborhood” White Paper. Agency for Healthcare Research and Quality, June 2011.CMS-1590-P 205

furnished to Medicare beneficiaries in an adva nced primary care practice environment, we would need to establish a set of parameters to determ ine whether or not a clin ical practice could be considered an advanced primary care pract ice (medical home). The foundation for our assessment could be whether the practice has the capacity to deliver comprehensive primary care

services that mirror the five func tions of the CPC initiative. Howe ver, we would need to identify explicit criteria in the form of documented proces ses and quantifiable practi ce attributes, such as the availability and capacity of electronic health records, to assess the presence of these five

functions. We could make our determination that a pr actice has implemented all identified functions and is, therefore, an advanced primary care practice, by recognizing one or more of the nationally available accreditation programs currently in use by major orga nizations that provide accreditation for advanced primary care practices, frequently credentialed as “PCMHs”. Having established recognition of accreditation by one of several national accreditation organizations, we might require that a provide r document through the enrollme nt process (PECOS) that the practice meets the definition of an Advanced Pr imary Care Practice to furnish comprehensive primary care services. We have identified four national models that provide accreditation for organizations wishing to become an advan ced primary care practice; the Accreditation Association for Ambulatory Health, The Join t Commission, the NCQA, and the Utilization

Review Accreditation Commission (URAC). While there are similarities between all four of the national models for PCMH accreditation, each model has different standards and areas of emphasis in its review and approval of organi zational capacity and function as a PCMH. For instance, according to a report prepared for CMS by the Urban Institute entitled, “PatientCentered Medical Home Recognition Tools: A Comparison of Ten Surveys’ Content and Operational Details” released in March of 2012, the NCQA places a heavier emphasis on HealthCMS-1590-P 206

IT than the other accred iting bodies in their measurement standa rds. This report can be viewed at the following link: http://www.urban.org/uploadedpdf/ 412338-patient-centered-medicalhome-rec-tools.pdf

. We believe that basing our determinati on on accreditation as a PCMH by a national accreditation organization would offer a number of benefits, including that their accreditation tools, which review specific as pects of practice including inform ation systems and organizational processes already are well known, widely used, and well respected. Level 3 NCQA accreditation, URAC, the Accreditation Associ ation for Ambulatory Health and Joint Commission accreditation standards are, despite their differences, very similar to the concepts of the comprehensive primary care services, and CM S could consider accepting accreditation from any of these as documentation that a group practi ce is an advanced primary care practice. Other payers currently recognize PCMH accreditation by these organizations for payment. A publication from the Medical Group Management Association (MGMA) “The Patient Centered Medical Home Guidelines: A Tool to Compare National Programs” found that all four of the national accreditation programs me t the guidelines set forth by the AAFP, the AAP, the ACP, and AOA in their 2011 guidelines. The MGMA report can be downloaded from the following

Website: http://www.mgma.com/Books/Patient-C entered-Medical-Home-Guidelines/

. However, we recognize that the cost to a prac tice to acquire accreditat ion from one of these accrediting organizations could be significant. In addition, the pr ocesses to receive accreditation as an advanced primary care practice under thes e guidelines can be lengthy. We also are concerned that some parts of the accreditati on processes for these accrediting organizations would be considered proprietary. We believe that Medicare payment should rely whenever feasible on criteria and tools that are in the public domain. We also reco gnize that it could be challenging for us to address how we could rely on a set of standards from a private accreditingCMS-1590-P 207

body while still retaining responsibi lity for accreditation outcomes. It is unclear at this time how we would balance the proprietary interests of these private orga nizations in their accreditation models with our responsibility to establish and maintain appr opriate transparency in our decision-making processes. If we were to move forward with a pro cess that would use the accreditation standards from a private sector organiza tion to make determinations as to whether a practice is an advanced primary care practice, we would need to determine whether to recognize one, some, or

all of the available and established accreditati on models. As we stated above, because each accreditation tool has different standards and emphasi zes different criteria, we are concerned that there could be consistency issu es if we were to recognize accreditation from all four organizations as evidence of certification to provide advanced primary care. It would be important to ensure that any of the accreditation tool(s) we sel ected met the goals of our policy. We specifically invite co mments regarding the processes that we should consider for application, confirmation that recognized accreditation standard s are met, and notifica tion of recognition as a PCMH if we were to recognize practices as advanced primary care practices based on accreditation as a PCMH by one or more of th e national accreditation organizations. 2. CMS-Developed Advanced Prim ary Care Accreditation Criteria Alternatively, we could devel op our own criteria using, for exam ple, the five functions of comprehensive primary care used in the CPC initi ative 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 speci fic physician practices m eet the criteria for advanced primary care. This could include creati ng our own criteria and processes for review or could include using existing accre diting bodies to meas ure compliance agains t advanced primary care criteria determined by CMS. This would cr eate more consistent standards for identifyingCMS-1590-P 208

advanced primary care practices and provide greater transparency in the certification process. If CMS was able to determine the validity of an orga nization’s application to be recognized to be an advanced primary care practice, this coul d reduce the cost to th e physician practice for accreditation. However, practices would still ne ed to invest in organizational process and infrastructure to meet advanced primary care criteria. Implementing an internal process to accredit practices as advanced primary care for purposes of Medicare payment could involve significant administrative cost. The amount of cost likely would depe nd on the rigor of the required criteria, and the amount of documentation and review required prior to approval as an advanced primary care practice.

If we established our own criteria in order to resolve the lack of standardization between the standards adopted by the various national accreditation or ganizations for PCMH, it is possible that the accrediting bodies would then be able to assist us in determining compliance with the CMS criteria. Depending on the nature of the criteria, the CMS criteria may cost less to implement but would likely require a practice to incur the cost for an accrediting body to review the practice’s compliance. We invite public comme nt on the potential approaches we could use to identify advanced primary care practices for purposes of Medicare payment, including the possible use of one or more national accrediting organizations (and whether meaningful use of certified electronic health record technology should be required for such accreditation)as part of a Medicare approval process, as well as any othe r potential approaches to accrediting advanced primary care practices that we have not discussed here. c. Beneficiary Attribution for Purposes of Payment One potential issue surrounding comprehensiv e primary care services delivered in an advanced primary care practice is attribution of a beneficiary to an advanced primary care practice. We would not expect that there would be more than one practice functioning as anCMS-1590-P 209

advanced primary care practice for a beneficiary at any given time. However, in a fee-forservice environment we would n eed to determine which practice is currently serving as the advanced primary care practice for the beneficiary in order to ensure appropriate payment. One

method of attribution could be that each benefi ciary prospectively chooses an advanced primary care practice. We seek comment on how such a choice might be documented and incorporated

into the fee-for-service environment. Othe r attribution methodologies might examine the quantity and type of E/M or ot her designated services furnishe d to that beneficiary by the practice. We welcome input on the most approp riate approach to the issue of how to best determine the practice that is functioning as the advanced primary care practice for each beneficiary. We are not consider ing proposals that would restrict a beneficiary’s free choice of practitioners. In summary, we believe that targeting pr imary care management payments to advanced primary care practices would 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 the 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 invite broad public comment on the

accreditation and attribution issues discussed abov e and any other aspect, including payment, of integrating an advanced primar y care model in to the PFS.CMS-1590-P 210CMS-1590-P 211

I. Payment for Molecular Pathology Services For CY 2012, the AMA CPT Editorial Panel began creating new CP T codes to replace the current codes used to bill for molecular path ology services. The new codes describe distinct molecular pathology tests and te st methods. CPT divided these new molecular pathology codes

into Tiers. Tier 1 codes desc ribe common gene-specific and genom ic procedures. Tier 2 codes capture reporting for less common tests and each Tier 2 code re presents a group of tests that involve similar technical resources and interp retive work. For CY 2012, CPT created 101 new molecular pathology codes; 92 new Tier 1 codes for individual te sts and nine Tier 2 codes for common groups of tests. These codes appear in Table 21. We anticipat e that CPT will create additional molecular pathology codes for CY 2013.

We stated in our notice for the Clinical Laboratory Fee Schedule (CLFS) Annual Public Meeting (to be held July 16-17, 2012 at CMS headquarters in Baltimore, Maryland, more

information at https://www.cms.gov//Medicare-Fee-for-ServicePayment/ClinicalLabFeeSched/Public_Meetings.html ) that we are following our process to determine the appropriate basis and payment am ounts for new clinical diagnostic laboratory tests, including the molecular pathology tests, un der the CLFS for CY 2013. However, we also

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 believe 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 said that we in tend to solicit comment on this issue in this proposed rule, as well as public comment on pric ing policies for these tests under the CLFS atCMS-1590-P 212

the Annual Public Meeting. This section first discusses and re quests comment on whether these molecular pathology CPT codes describe services that ordinarily requi re physician work, and then discusses our proposal to address paymen t for these CPT codes on the PFS, pending public comment on the first question. This proposal is parallel to the invitation to discuss at the CLFS Annual Public Meeting, the appropriate basi s for establishing a payment amount for the molecular pathology CPT codes as clinical di agnostic laboratory tests under the CLFS. As detailed in section II.B.1. of this propos ed rule, Medicare establishes payment under the PFS by setting RVUs for physician work, practi ce expense (PE), and malpractice expense for services that ordinarily requi re physician work. To establis h RVUs for physician work, we

conduct a clinical review of th e relative physician work (time by intensity) required for each PFS

service. This clinical review includes th e review of RVUs reco mmended by the American

Medical Association Relative Va lue Scale Update Committee (A MA RUC) and others. The AMA RUC-recommended physician work RVUs typi cally are based in part on results of a survey conducted by the relevant specialty societ y for a service. CMS establishes RVUs for PE under a resource-based PE methodology that consider s the cost of direct inputs, as well as

indirect PE costs. The AM A RUC, through the Practice Expe nse Subcommittee, recommends direct PE inputs to CMS, and the relevant spec ialty societies provide pricing information for those direct inputs to CMS. After we determ ine the appropriate direct PE inputs, the PE methodology is used to develop proposed 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 furnished in greater than 50 pe rcent of Medicare cases. CMS establishes resource-based malpractice expense RVUs using weighted speci alty-specific malpractice insurance premium

data collected from commerci al and physician-owned insurers in CY 2010 (74 FR 61758). For most services paid under the PFS, beneficiary co st-sharing is 20 percent of the payment amount.CMS-1590-P 213

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, carrier-s pecific amounts are established for the new test code using the following sources of information: charges for the test and routine discounts to charges; resources required to perform the test; payment amounts determined by other payers; and charges, payment amounts, and resources require d for other tests that may be comparable or

otherwise relevant. For the s econd year, the NLA is calculated, which is the median of the carrier-specific amounts. See §414.508. Servic es paid under the CLFS do not include any physician work, although tests paid under the CL FS can involve interpretation by a laboratory technician, a chemist, or a gene ticist – none of which are occupa tions that meet the statutory definition of a physician. While payments can va ry geographically due to contractor discretion across locality areas (which are the same loca lities used for the GPCIs under the PFS), payments cannot exceed a NLA nor can they be adjusted once rates are determined. In the CY 2008 PFS final rule with comment period, we adopted a pr ospective reconsideration process for new tests paid under the CLFS, allowing a single year for Me dicare and stakeholders to review pricing for new tests after the payment is initiall y established (72 FR 66275 through 66279, 66401 through 66402). Finally, the statute waives beneficiary cost-sharing for clinical laboratory diagnostic 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 theCMS-1590-P 214

requirements for clinical consultation service as defined in §415.130. The PFS pays for services that ordinarily require the work of a physician and, with regard to pathology serv ices, explicitly pays for both the professional and technical component of the services of a pathologist as defined in §415.130 including surgical pathology, cyt opathology, hematology, certain blood banking services, clinical consultations, and inte rpretive clinical laboratory 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 pa id through the CLFS. One stacking code, CPT code 83912 (molecular diagnos tics; interpretation a nd report) is paid on both the CLFS and the PFS. Payment for the inte rpretation and report of a molecular pathology test when furnished and billed by a physicia n is made under the PFS using the professional component (PC, or 26) of CPT code 83912 ( 83912-26). Payment for the interpretation and report of a molecular pathology test when furn ished by non-physician laboratory staff is made under the CLFS using CPT code 83912. Since the creation of new molecular pathol ogy CPT codes, there has been significant debate in the stakeholder community regardi ng whether these new molecular pathology codes describe physicians’ serv ices that ordinarily require physicia n work and would be paid under the PFS, or whether they describe c linical diagnostic laboratory test s that would be paid on the

CLFS. The AMA RUC reviewed the 101 new mo lecular pathology CPT codes and concluded

that 79 of 101 new molecular pathology codes include work furnished by a physician. The American Clinical Laboratory Association (ACLA) has indi cated that 32 of the 101 new molecular pathology codes are interpreted by a phys ician and that a physician may perform the technical component associated with of 2 of the 101 CPT codes. Only 15 of the 101 new codesCMS-1590-P 215

appear on both the AMA RUC and ACLA list of c odes that each believe include work furnished by a physician. Additionally, some stakeholders have suggested that all molecular pathology tests require physician interpreta tion and report. Other stakehol ders have suggested that the interpretation and report of a mo lecular pathology test is not or dinarily required because the majority of the molecular pathology tests are cl early negative so interp retation and reporting generally are not necessary. In addition, some stakeholders have argued that molecular pathology tests are becoming more and more automated, and ther efore generally do not require interpretation by a physician. In the CY 2012 PFS final rule (76 FR 73190), we stated that for CY 2012, Medicare

would continue to use the ex isting stacking codes for the re porting and payment of these molecular pathology services, and that the 101 ne w CPT codes would not be valid for payment

for CY 2012. We did this because we were concerned that we did not have sufficient

information to know whether these new molecu lar pathology CPT codes describe clinical diagnostic laboratory tests or serv ices that ordinarily require physician work. For CY 2013, we continue to have many of the same concerns that led us not to r ecognize the 101 molecular pathology CPT codes for payment for CY 2012. Specifically, we acknowledge that we are lacking definitive answers to the following questions:

● 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 report?

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

● Who furnishes interpretation se rvices and how frequently? We are seeking public comment on these questio ns and the broader issue of whether theCMS-1590-P 216

new molecular pathology codes desc ribe physicians’ services that should be paid under the PFS, or if they describe clinical diagnostic laboratory te sts that should be paid under the CLFS. As we continue to consider public comm ent on whether these molecular pathology CPT

codes describe services that ordi narily require physician work, we want to ensure that there is a payment mechanism in place to pay for these CP T codes for CY 2013. We propose to price all of the 101 new molecular pathology codes through a single fee schedule, either the CLFS or the PFS. After meeting with stakeholders and revi ewing each CPT code, we believe that there is little variation in the laboratory methodologi es, as all of them employ gene sequencing processes. However, there are very different processes for es tablishing payment rates under the PFS and the CLFS. As discussed above, Medi care sets payment under the CLFS by either crosswalking or gap-filling and, after the prospe ctive reconsideration process, currently cannot adjust the payment amount further. In contra st, Medicare sets payment under the PFS through a set of resource-based methodologies for physicia n work, PE, and malpractice expense, and payment can be reviewed and adjusted as the resources required to furnish a service change. We are concerned that establishing different prices for comparable laboratory services across two different payment systems would create a financ ial incentive to choose one test over another simply because of its fee schedule placement. We are also concerned that the differences in prices would become more pronoun ced over time as the PFS continue s to review the values for physician work and PE inputs relative to establ ished CLFS prices. Ther efore, because of the homogeneity of the laboratory me thodologies behind these procedure test codes, we believe that it is appropriate for al l 101 new molecular pathology CPT co des to be priced on the same fee schedule using the same methodology. We invite public comment on this proposal. In our effort to determine the appropriat e Medicare payment for these new molecular pathology codes, stakeholders will have the oppo rtunity to discuss the CLFS payment basis forCMS-1590-P 217

establishing payment amounts for the molecular pathology codes discusse d above at the CLFS Annual Public Meeting in July 2012. Section 1833(h)(8)(A) of the Act, which discusses the CLFS, requires the Secretary to “establish by regula tion procedures for determining the basis for, and amount of, payment [under the CL FS] for any clinical diagnostic laboratory test with respect to which a new or substantially revised HCPCS code is assigned on or after January 1, 2005.” Clauses (i) and (ii) of section 1833(h)(8)(B) of the Act requires the Secretary to: 1) make “available to the public (through an Internet website and other a ppropriate mechanisms) a list that includes any such test fo r which establishment of a paym ent amount... is being considered for a year;” and, “on the same day such list is made available, causes to have published in the Federal Register notice of a meeting to receive comme nts and recommendations (and data on which recommendations are based) from the public on the appropriate ba sis... for establishing payment amounts for the tests on such list.” Beca use we believe that these molecular pathology codes may be clinical diagnostic laborato ry tests payable on th e CLFS, comments and recommendations from the public on the approp riate basis for establishing payment amounts on

the CLFS will be discussed at the CY 2013 CLFS Annual Public Meeting. More information on

the CLFS Annual Public Meet ing is available in the Federal Register at 77 FR 31620 through

31622 and on the CMS Website at http://www.cms.hhs.gov/ClinicalLabFeeSched

. As a parallel to our invitation to discuss these molecular pathology codes as clinical diagnostic laboratory tests at the CLFS Annual Public Meeting in July 2012, we also propose payment amounts for these codes under the PFS for CY 2013. The AMA RUC provided CMS with recommendations for physician work RVUs and PE inputs for the 79 CPT codes it believes include physician work. At our request, CAP provided CMS with direct PE input recommendations for 15 of the remaining 22 CPT c odes to the best of their ability. We do not have recommendations on physician work RVUs or direct PE inputs for 7 of 101 codes whichCMS-1590-P 218

represent tests that are patent ed, and therefore the methodology us ed to furnish the service is proprietary and has been unavailable to th e AMA RUC or CMS to support developing appropriate direct PE inputs. For the 79 CPT codes, the AMA RUC-recommended physician work RVUs 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 in tra-service time of 18 minutes. We would note that the physician work RVU fo r CPT code 83912-26 and all but one of the ot her clinical diagnostic laboratory services fo r which CMS recognizes payment for clinical interpretation is

0.37. Table 21 lists AMA RUC -recommended physician work RVUs and times for these

services. Molecular pathology tests can be furnished in laboratories of diffe rent types and sizes (for example a large commercial laboratory or a pa thologist’s office), and tests may be furnished in small or large batches. The methodologies used and resources involved in furnishing a specific test can vary from la boratory to laboratory. 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 fu rnished by private laboratories, providing recommendations on the typical inputs was chal lenging for many services, and not possible for

other services. The AMA RUC and CAP-recomm ended direct PE inputs are available on the CMS Website in the files supporting this CY 2013 PFS proposed rule at http://www.cms.gov/Medicare/Medicare-Fee-fo r-Service-Payment/PhysicianFeeSched/PFSFederal-Regulation-Notices.html . We appreciate all of the e ffort CAP has made to develop national pricing inputs. However, we agree wi th its view that, in many cases, there is no established protocol for executing many of these tests and that the potential means to executeCMS-1590-P 219

these tests can vary considerably. In addition to recommendations on physician work and direct PE inputs, the AMA RUC provided CMS with recommended u tilization crosswalks for the 79 molecular pathology services it believes are typically furnishe d by a physician. 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 Medicare claims data. We use utilization crosswalk assumptions to ensure PFS BN and to create PE RVUs through the PE methodology. Currently, payment for the interpretation and report of a molecular pathology te st when furnished and billed by a physician is made under the PFS using CPT code 83912-26. Because CPT created the new molecular pathology codes to replace the current stacking codes, when recommending utilization crosswalks, the AMA RUC started with the tota l utilization for CPT code 83912-26, and divided that utilization among the 79 CPT codes. CAP ha s indicated that it dist ributed the utilization based, in part, on ICD-9 diagnosis data. Tabl e 22 lists the AMA RUC-recommended utilization

crosswalks for these services.

We are concerned that the RUC-recommended utilization is too low because it is based on the utilization of CPT code 83912-26 only. In stead, we believe that the utilization assumptions for the technical component of th e 101 new CPT codes should be based on the utilization of the corresponding CP T codes currently billed on the CLFS. Several laboratories provided us with a list of the molecular pathology tests that they perform, and identified the stacking codes that are currently used to bill fo r each test and the new CPT code that would be billed for each test. However, because the sa me molecular pathology test may be billed using different stacks, and the same stack may be bille d for different tests, it is not possible to

determine which stacks match which new CPT codes for all Medicare claims. Additionally, if a beneficiary has more than one test on the same date of service and both stacks are billed on theCMS-1590-P 220

same Medicare claim, it is not possible to dete rmine which stacking codes on the claim make up each stack. 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 molecular pathol ogy tests described by the new CPT codes. Given these factors,

it is difficult to estimate th e utilization of the 101 new molecular pathology codes based on the Medicare billing of the current stacking and NOC codes. If we were to finalize payment for molecula r pathology services unde r the PFS, we do not believe that we could propose national payment ra tes at this time. Many outstanding questions remain including:

● 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? Given these major areas of un certainty, if CMS determined that new molecular pathology CPT codes should be paid under the PFS for CY 2013, we are proposing to allow the Medicare contractors to price these codes because we do not believe we have sufficient information to engage in accurate national pricing and because the price of tests can vary locally. As previously discussed, this proposal is a parallel to the in vitation to discuss at the CLFS Annual Public Meeting the appropriate basis fo r establishing a payment amount for these molecular pathology tests as clinical diagnostic labor atory tests under the CLFS. If we decide to finalize payment for these new codes under the PFS, we would c onsider modifying §415.130 as appropriate to provide for payment to a pathologis t for molecular pathology services.CMS-1590-P 221

After reviewing comments received on the proposals contained with in this CY 2013 PFS proposed rule, and after hearing the discussi on at the CLFS Annual Public Meeting, we will determine the appropriate basis for establis hing payment amounts for the new molecular pathology codes. We intend to publish our fina l decision in the CY 2013 PFS final rule with comment period and, at the same time that rule is published, as stated in the CLFS Public Meeting Notice, to post final payment determinat ions, if any, for the molecular pathology tests that will be paid under the CLFS.

TABLE 21: AMA RUC-Recommended Phys ician Work RVUs and Times for New Molecular Pathology CPT Codes

CPT Code Short Descriptor AMA RUCRecommended Physician Work RVU AMA RUCRecommended Physician Intra-service Time (Minutes) 81206 Bcr/abl1 gene major bp 0.37 15 81207 Bcr/abl1 gene minor bp 0.15 11 81208 Bcr/abl1 gene other bp 0.46 18 81210 Braf gene 0.37 15 81220 Cftr gene com variants 0.15 10 81221 Cftr gene known fam variants 0.40 20 81222 Cftr gene dup/delet variants 0.22 13 81223 Cftr gene full sequence 0.40 20 81224 Cftr gene intron poly t 0.15 10 81225 Cyp2c19 gene com variants 0.37 13 81226 Cyp2d6 gene com variants 0.43 15 81227 Cyp2c9 gene com variants 0.38 14 81240 F2 gene 0.13 7 81241 F5 gene 0.13 8 81243 Fmr1 gene detection 0.37 15 81244 Fmr1 gene characterization 0.51 20 81245 Flt3 gene 0.37 15 81256 Hfe gene 0.13 7 81257 Hba1/hba2 gene 0.50 20 81261 Igh gene rearrange amp meth 0.52 21 81262 Igh gene rearrang dir probe 0.61 20 81263 Igh vari regional mutation 0.52 23 81264 Igk rearrangeabn clonal pop 0.58 22 81265 Str markers specimen anal 0.40 17 81266 Str markers spec anal addl 0.41 15 81267 Chimerism anal no cell selec 0.45 18 81268 Chimerism anal w/cell select 0.51 20 81270 Jak2 gene 0.15 10 81275 Kras gene 0.50 20 81291 Mthfr gene 0.15 10 81292 Mlh1 gene full seq 1.40 60 81293 Mlh1 gene known variants 0.52 28CMS-1590-P 222

CPT Code Short Descriptor AMA RUCRecommended Physician Work RVU AMA RUCRecommended Physician Intra-service Time (Minutes) 81294 Mlh1 gene dup/delete variant 0.80 30 81295 Msh2 gene full seq 1.40 60 81296 Msh2 gene known variants 0.52 28 81297 Msh2 gene dup/delete variant 0.80 30 81298 Msh6 gene full seq 0.80 30 81299 Msh6 gene known variants 0.52 28 81300 Msh6 gene dup/delete variant 0.65 30 81301 Microsatellite instability 0.50 20 81302 Mecp2 gene full seq 0.65 30 81303 Mecp2 gene known variant 0.52 28 81304 Mecp2 gene dup/delet variant 0.52 28 81310 Npm1 gene 0.39 19 81315 Pml/raralpha com breakpoints 0.37 15 81316 Pml/raralpha 1 breakpoint 0.22 12 81317 Pms2 gene full seq analysis 1.40 60 81318 Pms2 known familial variants 0.52 28 81319 Pms2 gene dup/delet variants 0.80 30 81331 Snrpn/ube3a gene 0.39 15 81332 Serpina1 gene 0.40 15 81340 Trb@ gene rearrange amplify 0.63 25 81341 Trb@ gene rearrange dirprobe 0.45 19 81342 Trg gene rearrangement anal 0.57 25 81350 Ugt1a1 gene 0.37 15 81355 Vkorc1 gene 0.38 15 81370 Hla i & ii typing lr 0.54 15 81371 Hla i & ii type verify lr 0.60 30 81372 Hla i typing complete lr 0.52 15 81373 Hla i typing 1 locus lr 0.37 15 81374 Hla i typing 1 antigen lr 0.34 13 81375 Hla ii typing ag equiv lr 0.60 15 81376 Hla ii typing 1 locus lr 0.50 15 81377 Hla ii type 1 ag equiv lr 0.43 15 81378 Hla i & ii typing hr 0.45 20 81379 Hla i typing complete hr 0.45 15 81380 Hla i typing 1 locus hr 0.45 15 81381 Hla i typing 1 allele hr 0.45 12 81382 Hla ii typing 1 loc hr 0.45 15 81383 Hla ii typing 1 allele hr 0.45 15 81400 Mopath procedure level 1 0.32 10 81401 Mopath procedure level 2 0.40 15 81402 Mopath procedure level 3 0.50 20 81403 Mopath procedure level 4 0.52 28 81404 Mopath procedure level 5 0.65 30 81405 Mopath procedure level 6 0.80 30 81406 Mopath procedure level 7 1.40 60 81407 Mopath procedure level 8 1.85 60 81408 Mopath procedure level 9 2.35 80CMS-1590-P 223

TABLE 22: AMA RUC-Recommended Utiliza tion Crosswalks for New Molecular Pathology CPT Codes Source Destination Analytic Ratio* 83912 26 81206 0.116 83912 26 81207 0.003 83912 26 81208 0.003 83912 26 81210 0.020 83912 26 81220 0.017 83912 26 81221 0.003 83912 26 81222 0.003 83912 26 81223 0.003 83912 26 81224 0.003 83912 26 81225 0.006 83912 26 81226 0.006 83912 26 81227 0.011 83912 26 81240 0.073 83912 26 81241 0.110 83912 26 81243 0.003 83912 26 81244 0.000 83912 26 81245 0.014 83912 26 81256 0.050 83912 26 81257 0.014 83912 26 81261 0.014 83912 26 81262 0.002 83912 26 81263 0.001 83912 26 81264 0.011 83912 26 81265 0.043 83912 26 81266 0.001 83912 26 81267 0.006 83912 26 81268 0.001 83912 26 81270 0.050 83912 26 81275 0.050 83912 26 81291 0.017 83912 26 81292 0.003 83912 26 81293 0.001 83912 26 81294 0.002 83912 26 81295 0.003 83912 26 81296 0.001 83912 26 81297 0.002 83912 26 81298 0.001 83912 26 81299 0.002 83912 26 81300 0.001 83912 26 81301 0.003 83912 26 81302 0.001 83912 26 81303 0.000 83912 26 81304 0.000 83912 26 81310 0.014 83912 26 81315 0.017 83912 26 81316 0.003 83912 26 81317 0.002 83912 26 81318 0.001 83912 26 81319 0.001 83912 26 81331 0.001 83912 26 81332 0.003 83912 26 81340 0.011 83912 26 81341 0.003 83912 26 81342 0.017 83912 26 81350 0.002 83912 26 81355 0.011 83912 26 81370 0.043 83912 26 81371 0.029 83912 26 81372 0.011 83912 26 81373 0.011 83912 26 81374 0.029 83912 26 81375 0.006 83912 26 81376 0.006 83912 26 81377 0.006 83912 26 81378 0.006 83912 26 81379 0.003 83912 26 81380 0.003 83912 26 81381 0.003 83912 26 81382 0.003 83912 26 81383 0.003 83912 26 81400 0.007 83912 26 81401 0.007 83912 26 81402 0.007 83912 26 81403 0.007 83912 26 81404 0.007 83912 26 81405 0.007 83912 26 81406 0.003 83912 26 81407 0.003 83912 26 81408 0.003 *Percentage of source code utilization transferred to the destination codeCMS-1590-P 224

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 23.

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;

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

● Intensive Behavioral Therapy for Obesity, effective November 29, 2011.

Table 23 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 in early November, so we could not indicate interim RVUs for theseCMS-1590-P 225

preventive services in our final rule addenda. However, we were able to include HCPCS Gcodes and national payment amounts for these services in the CY 2012 PFS national relative value files, which became available at the end of the year and were effective January 1, 2012. From the effective date of each service to December 31, 2011, the payment amount for these codes was established by the Medicare Administrative Contractors.

TABLE 23: 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 sexually transmitted infections, face-to-face, individual, includes: education, skills training, and guidance on how to change sexual behavior; performed semi-annually, 30 minutes Screening for Sexually Transmitted infections(STIs) and High- Intensity Behavioral Counseling (HIBC) to p revent STIs (NCD 210.10) CR7610

G0446 Annual, face-to-face intensive behavioral therapy for cardiovascular disease, individual, 15 minutes Intensive Behavioral Therapy for Cardiovascular Disease (NCD 210.11) CR7636

G0447 Face-to-face beha vioral 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. We believe that the screening service desc ribed by HCPCS code G0442 requires similar physician work as CPT code 99211 (Level 1 office or other outpatient visit, established patient), that may not require the presence of a physic ian. CPT code 99211 has a work RVU of 0.18 and

we believe HCPCS code G0442 shoul d be valued similarly. As such, we are proposing a work

RVU of 0.18 for HCPCS code G0442 for CY 2 013. For physician time, we are proposing 15CMS-1590-P 226

minutes, which is the amount of time specified in the HCPCS code descriptor. For malpractice expense, we are proposing a malpractice expe nse crosswalk to CPT code 99211. The proposed direct PE inputs are 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 http://www.cms.gov/PhysicianFeeSched/ . We request public comment on these CY 2013 proposed values for HCPCS code G0442, which ar e the same as the current (CY 2012) values

for this service.

We believe that the behavioral counseli ng service described by HCPCS code G0443 requires similar physician work to CPT code 97803 (Medical nutrition th erapy; re-assessment and intervention, individual, face-to-face with th e patient, each 15 minutes) (work RVU = 0.45) and should be valued similarly. As such, we are proposing a work RVU of 0.45 for HCPCS code G0443 for CY 2013. For physician time, we are proposing 15 minutes, which is the amount of time specified in the HCPCS code de scriptor. For malpractice expense, we are proposing a malpractice expense crosswalk to CPT code 97803. The proposed direct PE inputs are reflected in the CY 2013 proposed direct PE input database, available on the CMS Website under the downloads for the CY 2013 PFS proposed rule at http://www.cms.gov/PhysicianFeeSched/ . We request public comment on these CY 2013 proposed values for HCPCS code G0443, which ar e the same as the current (CY 2012) values

for this service.

HCPCS code G0444 (Annual Depression Screening, 15 minutes) was created for the reporting and payment of screening for depression in adults. We believe that the screening service desc ribed by HCPCS code G0444 requires similar physician work as CPT code 99211 (work RVU = 0.18) and should be valued similarly. As such, we are proposing a work RVU of 0.18 for HCPCS code G0444 for CY 2013. ForCMS-1590-P 227

physician time, we are proposing 15 minutes, whic h is the amount of tim e specified in the HCPCS code descriptor. For malpractice expe nse, we are proposing a malpractice expense crosswalk to CPT code 99211. The proposed dire ct PE inputs are reflected in the CY 2013 proposed direct PE input database, available on the CMS Website under the downloads for the CY 2013 PFS proposed rule at http://www.cms.gov/ PhysicianFeeSched/ . We request public comment on these CY 2013 proposed values for HC PCS code G0444, which are the same as the current (CY 2012) values for this service. HCPCS code G0445 (high-intensity behavi oral counseling to prevent sexually transmitted infections, face-to-face, individual, includes: educati on, skills training, and guidance on how to change sexual behavior, performed semi-annually, 30 minutes) was created for the reporting and payment of HIBC to prevent STIs.

We believe that the behavioral counseli ng service described by HCPCS code G0445 requires similar physician work to CPT code 97803 (work RVU = 0.45) and should be valued similarly. As such, we are proposing a work RVU of 0.45 for HCPCS code G0445 for CY 2013. For physician time, we are proposing 30 minutes, wh ich is the amount of time specified in the HCPCS code descriptor. For malpractice expe nse, we are proposing a malpractice expense crosswalk to CPT code 97803. The proposed dire ct PE inputs are reflected in the CY 2013 proposed direct PE input database, available on the CMS Website under the downloads for the CY 2013 PFS proposed rule at http://www.cms.gov/ PhysicianFeeSched/ . We request public comment on these CY 2013 proposed values for HC PCS code G0445, which are the same as the current (CY 2012) values for this service. HCPCS code G0446 (Annual, face-to-face intensive behavioral therapy for cardiovascular disease, individua l, 15 minutes) was created for the reporting and payment of intensive behavioral therapy for cardiovascular disease.CMS-1590-P 228

We believe that the behavioral therapy se rvice described by HCPC S code G0446 requires similar physician work to CPT code 97803 (work R VU = 0.45) and should be valued similarly. As such, we are proposing a work RVU of 0.45 for HCPCS code G0446 for CY 2013. For physician time, we are proposing 15 minutes, whic h is the amount of tim e specified in the HCPCS code descriptor. For malpractice expe nse, we are proposing a malpractice expense crosswalk to CPT code 97803. The proposed dire ct PE inputs are reflected in the CY 2013 proposed direct PE input database, available on the CMS Website under the downloads for the CY 2013 PFS proposed rule at http://www.cms.gov/ PhysicianFeeSched/ . We request public comment on these CY 2013 proposed values for HC PCS code G0446, which are the same as the current (CY 2012) values for this service. HCPCS G0447 (Face-to-face behavioral counsel ing for obesity, 15 minutes) was created for the reporting and payment of intens ive behavioral therapy for obesity.

We believe that the behavioral counseli ng service described by HCPCS code G0447 requires similar physician work to CPT code 97803 (work RVU = 0.45) and should be valued similarly. As such, we are proposing a work RVU of 0.45 for HCPCS code G0447 for CY 2013. For physician time, we are proposing 15 minutes, wh ich is the amount of time specified in the HCPCS code descriptor. For malpractice expe nse, we are proposing a malpractice expense crosswalk to CPT code 97803. The proposed dire ct PE inputs are reflected in the CY 2013 proposed direct PE input database, available on the CMS Website under the downloads for the CY 2013 PFS proposed rule at http://www.cms.gov/ PhysicianFeeSched/ . We request public comment on these CY 2013 proposed values for HC PCS code G0447, which are the same as the current (CY 2012) values for this service. K. Certified Registered Nurse Anesthetis ts and Chronic Pain Management ServicesCMS-1590-P 229

The benefit category for services furnished by a certified registered nurse anesthetist (CRNA) was added to Medicare by section 9320 of the Omnibus B udget Reconciliation Act (OBRA) 1986. Since this benefit was impl emented on January 1, 1989, CRNAs have been eligible to bill Medicare direc tly for the specified services. Section 1861(bb )(2) of the Act defines a CRNA as “a certified registered nurse an esthetist licensed by the State who meets such education, training, and other requirements relating to anesthesia services and related care as the Secretary may prescribe. In prescribing such requirements the Secretary may use the same requirements as those established by a national organization for the ce rtification of nurse

anesthetists.” 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 suchCMS-1590-P 230

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 esta blished, CRNA practice largely occurred in the surgical setting and services other than an esthesia (medical and surgical) were furnished in the immediate pre- and post- surgery timeframe. The scope of “anesthesia

services and related care” as delineated in se ction 1861(bb)(1) of the Act reflected that practice standard. As CRNAs have moved into other prac tice settings, questions have arisen regarding what services are encompassed under the “relat ed care” aspect of the benefit category. Specifically, some CRNAs now offer chronic pain management services that are separate and distinct from a surgical procedure. 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. Medicare Administrative Contractors (MAC s) have reached different c onclusions as to whether the statutory description of “anest hesia services and related care” encompasses the chronic pain management services delivered by CRNAs. As a re sult, we have been asked to address whether or not chronic pain management is included with in the scope of the statutory benefit for CRNA

services. To determine whether chronic pain management is included in the statutory benefit for CRNA services, we reviewed our current regulations and subregul atory guidance. We found that the existing guidance does not spec ifically address chronic pain management. In the Internet Only Manual (Pub 100-04, Ch 12, Sec 140.4.3), we discu ss the medical or surgical services that fall under the “related care” langua ge stating, “These may include the insertion of Swan Ganz catheters, central venous pressure lines, pain management, emergency intubation, and the preanesthetic examination and eval uation of a patient who does not undergo surgery.” Some haveCMS-1590-P 231

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 fu rnished in the perioper ative setting and refer only to acute pain management associated with the surgical procedure. Since existing guidance was not determinative, we assessed the issue of CRNA practice of chronic pain management more broadly. We found that chronic pain management is an emerging field. The Institute of Medicine (IOM ) issued a report entit led “Relieving Pain in America: A Blueprint for Transforming Preventi on, Care, Education and Research” on June 29, 2011, discussing the importance of pain manage ment and focusing on the many challenges in delivering effective chronic pain management. Th e available interventions to treat chronic pain have been expanding. In addition to the use of medications and a variet y of diagnostic tests, techniques include neural bloc ks, neuromodulatory techniques, and implanted pain management devices. The healthcare community continues to examine the appropriateness and effectiveness of these many and varied treatment techniques and modalities. As part of this evolution, Medicare established a physician specialty code for interventional pain management in 2003. The healthcare community continues to deba te whether CRNAs are qualified to provide chronic pain management. Some have stated that interventional pain management for beneficiaries with chronic pain is the practi ce of medicine, that CRNAs do not receive the sufficient education on chronic pain manageme nt, and that CRNAs do not have the skills required to furnish chronic pain management servi ces. Others have stated that both acute and chronic pain management and treatment are within the CRNA professional scope and are comparable services, and that CRNAs receive th e clinical training and experience necessary to furnish both acute and chronic pain management services. Recently, several State legislaturesCMS-1590-P 232

have debated the scope of CRNA pr actice, including those in the St ates of California, Colorado, Missouri, South Carolina, Nevada, and Virginia. In the context of Medicare, some have poi nted to Medicare po licies allowing other advanced practice nurses such as nurse practitioners or clinical nurse specialists to furnish and bill for physicians’ services as support for recogn izing a broader interpretation of the scope of CRNA practice. We would note that the stat utory benefit category definition for CRNAs substantively differs from that for other advan ced practice nurses. Section 1861(s)(2)(K) of the Act authorizes certain nonphysicia n practitioners (NPPs) to bill Medicare directly for services they are legally authorized to perform under Stat e law, and “which would be physicians’ services if furnished by a physician.” With certain conditions (such as physician supervision or collaboration), the statute allows these NPPs to bill Medicare for physicians’ services that fall within their State scope of practice. Since State governments regulate the licensure and practice of specific types of health care professionals, we have looked to the State sc ope of practice laws to determine if chronic pain management was within the scope of practic e for CRNAs. State scope of practice laws vary with regard to the range of se rvices that CRNAs may perform, and some include chronic pain management. As discussed earlier, several States are debating whether to include chronic pain management services within the CRNA scope of practice. After assessing the information available to us, we have concluded that chronic pain management is an evolving field, and we recognize that certain States have determined that the scope of practice for a CRNA should include chroni c pain management in order to meet health

care needs of their residents and en sure their health and safety. Therefore, we propose to revise our regulations at §410.69(b) to define the statut ory description of CRNA services. Specifically, we propose to add the following language: “A nesthesia and related care includes medical andCMS-1590-P 233

surgical services that are related to anesthesia and that a CRNA is legally authorized to perform by the State in which the services are furnished.” This proposed definition would set a Medicare

standard for the services that can be furnishe d and billed by CRNAs while allowing appropriate flexibility to meet the unique needs of each Stat e. The proposal also dovetails with the language in section 1861(bb)(1) of the Ac t requiring the State’s legal authorization to perform CRNA services as a key component of the CRNA benef it category. Finally, the proposed definition is also consistent with our policy to recognize State scope of practice as one parameter defining the

services that can be furnishe d and billed by other NPPs. Simply because the State allows a certain t ype of health care professional to furnish

certain services does not mean th at all members of that profe ssion are adequately trained to provide the service. In the case of chronic pa in management, the IOM re port specifically noted that many practitioners lack the skills needed to help patients with the day-to-day selfmanagement that is required to properly serv e individuals with chronic pain. As with all practitioners who furnish services to Medicare beneficiaries, CRN As practicing in States that allow them to furnish chronic pain manageme nt services are responsible for obtaining the necessary training for any and all services furnished to Medicare beneficiaries. L. Ordering of Portable X-Ray Services Portable x-ray suppliers provi de diagnostic imaging services at a patient’s location.

These services are most often furnished in re sidences, including private homes and group living facilities (for example, nursing homes ) rather than in a traditional cl inical setting (for example, a doctor’s office or hospital). The supplier transports mobile dia gnostic imaging equipment to the patient’s location, sets up the equipment, and administers the test onsite. The supplier may interpret the results itse lf or it may provide the results to an outside physician fo r interpretation.CMS-1590-P 234

Portable x-ray services may avoid the need for expensive ambulance transport of frail patients to a radiology facility or hospital. In the Medicare Conditions for Coverage regulations estab lished in 1969, §486.106(a), requires that “portable x-ray examinations ar e performed only on the order of a doctor of medicine (MD) or doctor of osteopathy (DO) li censed to practice in the State...” With the exception of portable x-ray services, Medicare payment regulations at §410.32 allow physicians, including limited-license practit ioners such as doctors of po diatry and optometry, and most nonphysician practitioners who furnish physicians’ services to order di agnostic x-ray tests, diagnostic laboratory tests, and other diagnostic tests so long as those nonphysician practitioners are operating within the scope of their authority under State law and within the scope of their Medicare statutory benefit. Nonphysician practitioners have become an increasingly importa nt component of clinical care, and we believe that delivery systems s hould take full advantage of all members of a healthcare team, including nonphysician practitioners. Although current Medicare regula tions limit ordering of portabl e x-ray services to a MD or a DO, the Office of the Inspector Gene ral (OIG) in its Decem ber 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. SinceCMS-1590-P 235

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 propose to revise our current regula tions, 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 thei r Medicare benefit and State law to order portable x-ray services. Specifically, we propose revisions to the Conditions for Coverage 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 diagnostic services under §410.32(a). This proposed change would allow a MD or DO, as well as an 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,

and clinical social worker to or der portable x-ra y services within their State scope of practice and the scope of their Medicare benefit. Although all of these physicians and nonphysician practitioners are authorized to order diagnostic services in accordance with §410.32(a), their

Medicare benefit delimits the serv ices that they can provide. We also propose to revise the language in cluded in §410.32(c) to recognize the same authority for physicians and nonphysician practitioners to order diagnostic te sts as is prescribed for other diagnostic services in §410.32(a). Finally, we are propos ing two technical corrections. One is to §410.32(d)(2), where we currently c ite to subsection (a)(3) for the definition ofCMS-1590-P 236

qualified nonphysician practitioner. The defin ition of qualified nonphysicia n practitioner is in paragraph (a)(2) and paragraph (a)(3) does not exis t; therefore, we are changing the citation to

the correct citation. The sec ond technical correcti on is §410.32(b)(2)(iii) to better reflect statutory authority to provide neuropsychological testing in a ddition to psychological testing. Although we believe that this proposal is appr opriate given overall changes in practice patterns since the beginning of the Medicare program, we rema in concerned about the OIG’s recent findings. The OIG observed questionable b illing patterns for porta ble x-ray services in addition to ordering by nonphysician practitioners . Of specific note was the observation that some portable x-ray suppliers are delivering serv ices on the same day that the patient also

receives services in a clinical setting, such as the physician offi ce or hospital. Under our current regulation at §486.106(a)(2), the order for portabl e x-ray services must include a statement concerning the condition of the patient whic h indicates why portable x-ray services are necessary. If the patient was able, on the same da y that a portable x-ray service was furnished, to travel safely to a clinical se tting, the statement of need for portable x-ray services could be questionable. We also are concerned that the OIG observed some portable x-ray suppliers billing for multiple trips to a facility. Medicare make s a single payment for each trip the portable x-ray supplier makes to a particular location. We make available mu ltiple modifiers to allow the portable x-ray supplier to indicate the number of patie nts served on a single tr ip to a facility. We expect portable x-ray suppliers to use those modi fiers and not to bill multiple trips to the same facility when only one trip was made. Add itionally, we strongly encourage portable x-ray suppliers to make efficient use of resources a nd consolidate trips rather than making multiple trips on the same day as c linically appropriate. 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, monitoringCMS-1590-P 237

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

this service and to allow for the collection of any potential overpayments. We encourage providers, as with any diagnostic test, to pr oactively determine and document the medical necessity for this testing. We are also considering whethe r to make other revisions to the current regulations at 42 CFR, Part 486, Subpart C—Conditions for Coverage : Portable X-Ray Services through future rulemaking, as we are aware stakeholders have suggested regulatory cha nges to consider since the last update of this regulation. The last time this regulation was updated was in 2008, but many of the sections in Part 486, Subpart C ha ve not been updated si nce 1995. Since we are proposing to update part of Part 486, Subpart C in this proposed rule , we are using this opportunity to seek public commen t on suggestions for updating in the future the rest of the regulations at Part 486, S ubpart C. We are open to all sugges tions for updates; therefore we did not pose specific questions for response by the public. We are specifically seeking public comm ent on suggestions for updating Subpart C— Conditions for Coverage: Portable X-Ray Servic es; noting that any regulatory changes would be addressed through separate not ice-and-comment rulemaking.CMS-1590-P 238

III. Other Provisions of the Proposed Regulation

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 increased 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) toCMS-1590-P 239

conform the regulations to this statutory requirement. Howeve r, in doing so, paragraphs (c)(1)(ii)(A) and (B) were inadvertently dele ted from the Code of Federal Regulations. Therefore, we propose 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 after January 1, 2012 and before January 1, 2013. Accordingly, we are proposing to revise §414.610(c)(1)(ii) to conform the regulations to these statutory requirements. 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 under the ambulance fee sc hedule 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 theCMS-1590-P 240

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 further amended section 146(b)(1) of MIPPA to extend this provision through December 31, 2012. Therefore, we are proposing to revise §414.610(h) to conform the regulations to these statutory requirements. These statutory requirements ar e self-implementing. A plain reading of the statute requires only a ministerial application of a rural indicator, a nd does not require any

substantive exercise of discretion on the part of the Secretary. Accordingly, for areas that were designated as rural on December 31, 2006, and were subsequently re-designated as urban, we

have re-established the “rural” indicator on the ZIP Code file for air 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 ruralCMS-1590-P 241

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 Goldsmith 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 qualifiedCMS-1590-P 242

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. Accordingly, we are proposing to revise §414.610(c)(5)(ii) to conform the regulations to the statutory requirements set forth at section 306(c) of the TPTCCA and section 3007(c) of the MCTRJCA. These statutory re quirements are self-implementi ng. Together, these provisions require a one-year extension of the rural bonus (which was previously established by the Secretary) through December 31, 2012, and does not require 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 furnished under the DME benefit, certain oral anti-cancer drugs, and oral immunosuppressive drugs. 1. Widely Available Market Price (WAMP) /Average Manufacturer Price (AMP) price

substitution For a drug or biological that is found to have exceeded the WAMP of AMP by a threshold percentage, section 1847A(d)(3)(C) of th e Act authorizes the Secretary to substitute,

the lesser of --

● The widely available market pric e for the drug or biological, or

● 103 percent of the average manufacturer price as determined 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 theCMS-1590-P 243

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.

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 have no additional info rmation from OIG studies or ot her sources that leads us to

consider an alternative threshold. When maki ng comparisons to the WAMP, we propose that the applicable threshold percentage remain at 5 perc ent until such time that a change in the threshold amount is warranted, and we propose to update §414.904(d)(3)(iv) accordingly. As mentioned above, the threshold has remained at 5 percent since 2005. Our proposal w ill eliminate the need for annual rulemaking until a change is warranted. We are not proposing to make any WAMP base d price substitutions at this time. As we

noted in the CY 2011 PFS final rule with comm ent period (75 FR 73470) and reiterated in CY 2012 (76 FR 73287), we understand that there are comp licated operational issues associated with the WAMP based substitution policy, and we conti nue to proceed cautiously in this area. We remain committed to providing stakeholders, in cluding providers and manufacturers of drugs 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.CMS-1590-P 244

b. AMP Threshold Like the WAMP threshold, for CY 2013, we have no information that leads us to believe that the 5 percent thre shold percentage for AMP-based pri ce substitution is inappropriate or should be changed. We propose that the applicab le threshold percentage remain at 5 percent until such time that a change in the threshold amount is warranted, and we propose to update §414.904(d)(3)(iii) accordingly. Th e AMP threshold has remained at 5 percent since 2005. Our proposal will eliminate the need for annua l rulemaking until a change is warranted.

c. AMP Price Substitution-Additional condition 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 two consecutive quarters immediately prior to the current pricing quarter, or three of the previous four quarters immediately prior to the current quarter, and that matchi ng sets of NDCs had to be used in the comparison (76FR 73289 through 73295). The value of the AMP based price substation must also be less than the ASP payment limit that is calculated for the qua rter in which the substitution is applied. 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 propose addi ng §414.904(d)(3)(ii)(C) that 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 shortCMS-1590-P 245

supply at the time that ASP payment limits are bei ng finalized for the next quarter. Further, we also would like to clarify that this proposal to add to the safeguards finalized in CY 2012 only applies to calculations under th e AMP-based price substitution policy. Our proposal is intended to continue the cautious approach described in previous rules and to st rike a balance between operational requirements associated with receiving manufacturers’ ASP reports, calculating the payment limits, and posting stable payment limits th at will be used to pay claims. We believe that this proposal also addresses concerns a bout access to care, known program issues identified by the OIG, and provides an opportunity for some m odest program savings. At this time, we are not proposing any other changes to the safeguards, timing, or notification that identifies the codes that will be substituted each quarter. We welcome comments on our approach as well as comments regarding additional specific safeguards for the AMP price substitution policy. 2. Billing for Part B Drugs Administered Incident to Physicians’ Services. In this section, we propose to clarify paymen t policies regarding billing for certain drugs under Medicare Part B. In 2010 and 2011, we is sued two change requests (CRs 7109 and 7397) that summarized a number of longstanding drug pa yment 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 physicians’ service, has caused some concer n. Specifically, we understand that some nonphysician suppliers – operating in part on the basis of guidance fr om a Medicare contractor – have been submitting claims for drugs that they have shipped to physicians’ offices for use in refilling implanted intrathecal pumps. In light of concern over its poten tial 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 u ndertake rulemaking, evaluate public commentsCMS-1590-P 246

on this issue, and determine whether CR 7397 sh ould 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, an item or serv ice must fall within one or more benefit categories within Part A or Part B, and must not be otherwise excluded from coverage. Drugs and biologicals paid under Medi care part B drugs fall into three 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 office and then billed by the physician to the Medicare Admi nistrative Contractor (MAC).

● 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 either pharmacies (or general DME s uppliers that utilize licensed pharmacists) for administration in a setting other than the physician’ s office. Most DME dr ugs are billed to the

DME MAC.

● Drugs specified by the statute : Include a variety of drugs, such as oral immunosuppressives and certain vaccines. Drugs used to refill an implanted intrathecal pu mp can be considered to be within either the “incident to” or the DME benefit categor y. The CMS Benefit Policy Manual (100-02CMS-1590-P 247

Chapter 15 Section 50.3) states th at drugs paid under the “incid ent to” provision are of a form that is not usually self-administered; are furn ished by a physician; and are administered by the physician, or by auxiliary personnel employed by the physician and under the physician’s personal supervision. In what we believe is a typical situation, when physicians’ services are used to refill an intrathecal pump, the “incident to” requirements can be met because, consistent with our guidance and longstanding policy, the p hysician or other professional employed by his or her office performs a procedur e to inject the drug into the implanted pump’s reservoir (that is, the drug is not self-administered) and the drug represents 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 a procedure. Moreover, in the case of prescription drugs used in conjunction with DME, our guidance is clear that the entity th at dispenses the drug need s to furnish it directly to the patient for whom a prescription is writ ten. We do not believe that an arrangement whereby a pharmacy (or supplier) ships a drug to a physician’s office for administration to a patient constitutes 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 dispensed to a patient and the implanted pump is refilled without a physicia n’s service. However, it is our understanding that implanted pumps are rarely refilled w ithout utilizing the se rvice of a physician.

We are concerned about stakeh olders’ reports that, due to guidance from a contractor, Medicare payment policy on this issue has been app lied in an inconsistent manner. We considerCMS-1590-P 248

the contractor’s guidance to be erroneous. This inconsistency has permitted supplier claims for drugs dispensed by pharmacies to physicians’ offices to be paid in some jurisdictions and has denied such payment in others. We understand th at the inconsistent appl ication of our payment policy has influenced the business and profession al practices of pharmacies/DME suppliers that prepare drugs for implanted pumps. However, we do not believe that payment for drugs used to refill implanted DME should continue to be ma de because such action is not supported under long standing policy and, as discussed above, is not appropriate. We therefore propose to clarify that we consider drugs used by a physician to refill an implantable item of DME to be within the “i ncident to” benefit cat egory and not the DME benefit category. Therefore, th e physician must buy and bill fo r the drug, and a non-physician supplier that has shipped the drug to the physic ian’s office may not do so (except as may be permitted pursuant to a valid reassignment). We welcome comments on this proposal and its potential impact on benefi ciaries and providers.CMS-1590-P 249

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 DME items and §410.36(b) for prosthetic devices, orthotics, and prosthetics. Both of these sections state that as a requirement for payment, CMS, a carrier, or, more recently, a Medi care Administrative Contractor (MAC) may determine that an item of DME requires a written physician order before delivery. In addition to our regulations at §410.38(g) and §410.36(b), we have stated in Chap ter 5, Section 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 mechanisms; (3) transcutaneous electrical nerve stimulation (TENS) units; (4) power operated vehicles (POVs) and power

wheelchairs. Section 6407(b) of the Affordable Care Act amended section 1834(a)(1 1)(B) of the Act. It added language that require s a written order for certain items of DME, which under section 1834(h)(3) of the Act also could include prosthetic devices, orthotics, and prosthetics, to beCMS-1590-P 250

issued per 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. The encounter must occur during th e 6 months prior to th e written order for each item or during such other reasonable tim eframe as specified by the Secretary. 2. Provisions of the Proposed Regulations

a. DME Face-to-Face Encounters (1) General Requirements We are proposing to first revise §410.38(g) to require, as a co ndition 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 f ace-to-face encounter with the beneficiary no more than 90 days before the or der is written or within 30 days after the order

is written. We make this proposal because we believe that a face-to-face encounter that occurs within 90 days prior to the wr itten order for DME should be re levant to the reason for the beneficiary's need for the item of DME, and th erefore, this face-to-face encounter should substantiate that the beneficiary's condition wa rrants the covered item of DME and be sufficient to meet the goals of this statutory requirement . However, we recognize that there may be circumstances when it may not be possible to meet this general requirem ent of "prior to the written order," and that in such cases, beneficiar y access to needed items mu st be protected. If a face-to-face encounter occurs within 90 days of the written order, but is not related to the condition warranting the need for the item of DM E, or if the beneficiary has not seen the physician or PA, NP, or CNS within the 90 days pr ior to the written order, we propose to allow a face-to-face encounter up to and including 30 days af ter the order is written in order to ensure

access to needed items.CMS-1590-P 251

During the face-to-face encount er the physician, a PA, a, NP, or a CNS must have evaluated the beneficiary, conducted a needs as sessment for the beneficiary or treated the beneficiary for the medical condition that supports the need for each covered item of DME. As a matter of practice, this information would be pa rt of the beneficiary's medical record, which identifies the practitioner who pr ovided the face-to-face assessment. We believe that requiring a face-to-face encounter that supports the need for th e covered item of DME would reduce the risk of fraud, waste, and abuse since these visits w ould help ensure that a beneficiary's condition

warrants 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 document that the physician, a PA, a NP, or a CNS has had a face-to-face encounter (other than with respect to encounters th at are incident to services 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.

We note that a face-to-face enc ounter may be accomplished via a telehealth encounter if all Medicare telehealth requirements as defi ned under section 1834(m) of the Act and the implementing regulations in §410.78 and §414.65 are met. Specifically, Medicare telehealth services can only be furnished to an eligible telehealth beneficiary in an originating site. The requirements in this proposed rule do not supers ede the requirements of telehealth and merely apply to the telehealth benefit where applicable. In general, originating site s must be located in a rural health professional shortage area (HPSA) or in a county outside of a metropolitan statistical area (MSA). The practitioner at the distant site may be a phys ician, PA, NP, or CNS, and the encounter must be reported with a healthcare procedure common coding system (HCPCS) codeCMS-1590-P 252

for a service on the list of approved Medicare teleh ealth services for the applicable year. In the May 5, 2010 Federal Register (76 FR 25550), we published a fi nal rule that revised the conditions of participation (CoPs) for hospitals and critical access hos pitals (CAHs). These revisions implement a new credentialing and privileging process for physicians and other practitioners providing telemedici ne services. We refer readers to the CMS Website for more information regarding te lehealth services at http://www.cms.gov/Telehealth/

. A single face-to-face encounter , including those facilitated th rough the appropriate use of telehealth, can support the need for multiple co vered items of DME as long as it is clearly documented in the pertinent medical record that the beneficiary was evaluated or treated for a condition that supports the need for each covere d item of DME, during the specified period of

time. To promote the authenticity a nd comprehensiveness of the wr itten order and as part of our efforts to reduce the risk of waste, fra ud, and abuse, we propose that as a condition of payment a written order must incl ude: (1) the beneficiary name; (2) the item of DME ordered; (3) prescribing practitioner NPI; (4) the signature of the prescribing practit ioner; (5) the date of the order; (6) the diagnosis; and (7) necessary proper usage instruc tions, as applicable. Examples of necessary proper usage instruction could incl ude duration of use, me thod of utilization, and correct positioning. We recognize that standards of pr actice may require that orders contain

additional information. Howeve r, for purposes of this proposed rule, which is focused on implementing section 1834(a)(11)(B) of the Act a nd reducing fraud, waste, and abuse, an order

without these minimum elements would be considered incomplete and would not support a claim for payment. We believe includ ing this information on the writt en order would be a safeguard against waste, fraud, and abuse by promoting auth enticity and comprehensiv eness of the order by the practitioner.CMS-1590-P 253

Based on our commitment to the general principles of the President's Executive Order entitled "Improving Regulation a nd Regulatory Review” (released January 18, 2011) and to be consistent with other provisions in the amendm ents made by section 6407(a) of the Affordable Care Act and the provisions of section 6407 (d) of the Affordable Care Act as discussed above, we are proposing to require that the face-to-face encounter occur no earlier than 90 days prior to

each written order for a covered ite m of DME or within 30 days afte r the order is written. This proposal is consistent with the Medicare a nd Medicaid home health face-to-face requirement which increases physician accountability and specifi es a timeframe within the discretion of the Secretary. (For more information on the Me dicare and Medicaid home health face-to-face requirements see the November 17, 2010 final rule (75 FR 70372) and the July 12, 2011 proposed rule (76 FR 41032) for Medicare and Medi caid respectivel y.) We have exercised our

discretion to set a timeframe other than 6 months because we believe that our proposal strikes an appropriate balance among several factors: (1) the potential for fraud, waste, abuse associated with certain DME items; (2) the potential in convenience and cost to practitioners and beneficiaries; and (3) potential health benefits to beneficiar ies from increased practitioner involvement and more periodic review s of their status and progress. We perform ongoing education on many topics including the requirements of the other face-to-face provisions. This education include s, but is not limited to, various Medicare Learning Network® products such as MLN Matter s® articles, brochures, fact sheets, Web-based training courses, and podcasts; Open Door fo rums; and national provider conference calls. Medicare is already working pr oactively with home health agencies, physicians, and other providers to educate them on implementing the face-to-face requirement. We plan to conduct similar provider education and outreach in im plementing the DME face-to-face requirement.

As noted previously, section 1834(h)(3) of the Ac t adds prosthetic devices, orthotics, andCMS-1590-P 254

prosthetics to the items encompassed by section 1834( a)(11)(B) of the Act. At this time, we are not proposing changes to §410.36(b) to require documentation of a face-to-face encounter for prosthetic devices, orthotics, and prosthetic s that, according to §410.36(b), require a written order before delivery in this proposed rule. We intend to use future rulemaking to determine which prosthetic devices, orthotic s, and prosthetics, require, as a condition of payment, a written order before delivery supported by documenta tion of a face-to-face encounter with the beneficiary consistent with se ction 1834(a)(11)(B)(ii) of the Act. We welcome comments on including prosthetic devices, orthotics, and pr osthetics in future ru lemaking, including any

criteria that should be used fo r determining what items should require a written order before delivery supported by documentation of a face-to-face encounter. This proposed requirement does not supersed e any regulatory requirements that more specifically address a face-to-face encounter requirement for a pa rticular item of DME. For example, §410.38(c), which implemented section 1834( a)(1)(E)(iv) of the Act, specifically addresses prescription and face-to-face encounter requirements for power mobility devices (PMDs) and uses a 45-day period between the date of the face-to-face enc ounter and the date of the written order. That requirement is speci fic to the unique factor s, including equipment expense and complex medical necessity determinations that affect PMDs. (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 benefici ary. We propose that when the face-to-face encounter is performed by a physician, the subm ission of the pertinen t portion(s) of the beneficiary’s medical record, containing sufficient information to document that the face-to-face encounter meets our requirements, would be c onsidered sufficient and valid documentation of

the face-to-face encounter when submitted to the supplier and made available to CMS or itsCMS-1590-P 255

agents upon request. Some examples of pertinent parts of the beneficiary's medical record that

can demonstrate that a face-to-face encounter ha s occurred can include: history; physical examination; diagnostic tests; summary of fi ndings; diagnoses; treatment plans; or other information as appropriate. As an alternativ e, we are requesting comments on a second option for physicians to document the face-to-face encount er when it is performed by the physician, by requiring this physician documentation to be identic al to what is required for a PA, a NP, or a

CNS as discussed later in this se ction. We strive to find the opti on that strikes a balance between minimizing the effect on physicians, while still meeting the statutory obj ective to limit fraud, waste, and abuse. (3) Physician Documentation of Face-to-Face En counters Performed by a Physician Assistant, Nurse Practitioner, or Clinical Nurse Specialist We are considering the following proposed options for physician documentation of a face-to-face encounter performed by a PA, NP, or CNS. We are reserving judgment as to which of these proposed options best accomplishes our goals until the final regulation and have not provided language reflecting these options in the proposed regulati ons text. The options are as

follows:

● Option 1 : Attestation stating: "I , Doctor (Name) (NPI nu mber) have reviewed the medical record and attest that (PA, NP or CNS) has performed a face-to-face encounter with (beneficiary) on (date) and evaluated the need fo r (the item of DME)." (Sign)(Date). This option would provide all the needed information to document that a face -to-face encounter has occurred between the PA, NP or CNS and the bene ficiary in a standardi zed manner. However,

this attestation would not eliminate the need for the medical record to support the medical necessity of the ordered item. The attestati on serves only as physic ian documentation of the

face-to-face encounter.CMS-1590-P 256

● Option 2 : The physician signs or cosigns the pe rtinent portion of the medical record, for the beneficiary for the date of the face- to-face encounter, thereby documenting that the beneficiary was evaluated or treat ed for a condition relevant to an item of DME on that date of service. This option would provide evidence that the physician has reviewed the relevant documentation to support that a face-to-face encounter occurred for that date of service. A signed order by the physician alone would not satisfy the requirem ent described in this option that the physician "sign/cosign the pertin ent portion of the medical record."

● Option 3 : The physician specifically initials the history an d physical examination for the beneficiary for the date of the face-to -face encounter, thereby documenting that the beneficiary was evaluated or treat ed for a condition relevant to an item of DME on that date of service. This option would provide evidence that the physician has reviewed the relevant documentation to support that a face-to-face encounter occurred for that date of service. A signed order would not satisfy the requirement described in this op tion that the physician "initial the history and physical examination for the be neficiary for the date of the face-to-face

encounter". We welcome comment on how physician docume ntation requirements should be handled

when the face-to-face encounter with the benefici ary is conducted by a PA, a NP, or a CNS. We are looking for the alternative that best accomplis hes the objective of reducing waste, fraud, and abuse by having a physician document the face-to-f ace encounter if it is pe rformed by a PA, NP, or CNS without creating undue impact. (4) Supplier Notification Since the supplier submits the claims for th e covered items of DME, the supplier must

have access to the documentation of the face-to-face encounter. We welcome comment on the type of communication that s hould occur between the physician or PA, NP, or CNS, and theCMS-1590-P 257

supplier. All documentation to support the appropriateness of the item of DME ordered including documentation of the face-to-face encount er, must be available to the supplier. As

with all items and servic es, we require both the ordering practit ioner and the supplier to maintain access to the written order and supporting documenta tion relating to written orders for covered items of DME and provide them to us upon our reque st or at the request of our contractors. We are considering adding one of the fo llowing proposed options on how documentation

of the face-to-face encounter must be delivered to the supplier. We are reserving judgment on these proposed options until the final regul ation. The options are as follows:

● Option 1 : Require the practitioner who wrot e the order to provide the physician

documentation of the face-to-face encounter dire ctly to the DME supplier. This option may increase practitioner accountabi lity, since it requires practitioners to submit the required documentation to the supplier.

● Option 2 : Require the physician who completes the documentation of the face-to-face encounter to provide that documen tation directly to the DME supplier. This option is consistent with current policies where th e entity who submits the cl aims collects the necessary documentation even if it comes from multiple so urces. For example, the supplier must have access to all documentation necessary to support the claim upon request.

● Option 3 : Require that the documentation, no ma tter who completes it, be provided to the DME supplier through the same process as the written order for the covered item of DME.The option ensures that the same pathway followed for the order is also followed for the face-toface documentation. In most circumstances, we would expect the order and the face-to-face documentation to travel together, the exception be ing those circumstances where the face-to-face

encounter was conducted after the order.CMS-1590-P 258

● Option 4 : Require a physician to provide a co py of the face-to-face documentation to the beneficiary for the beneficiary to deliver to the DME supplier of his or her choice. This would ensure that the supplier receives the docum entation of the face-to -face encounter directly and limits the supplier’s need to rely on the PA, NP, or CNS to receive this documentation completed by the physician. We welcome comment on these options in or der to facilitate open communication and

enhanced coordination of documentation of a face-to-face encounter between the supplier, physician or when applicable, the PA, NP or CNS.

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 are proposing a list of Specified C overed Items that would require a written order prior to delivery. Our proposed list of Specified Covered Items is below. In future years, updates to this list would appear annually in the Federal Register and the full updated list

would be available on the CMS Website. As highlighted in the January 2007 Govern ment Accountability Office (GAO) report entitled, "Improvements Needed to Address Im proper Payments for Medical Equipment and Supplies" it is estimated that there were $700 m illion 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 proposed rule is one way in which we are working to prevent improper payments.CMS-1590-P 259

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 encounter requirement, we have first pr oposed a more limited criteria

driven list to balance what we believe to be br oad statutory intent to establish a face-to-face requirement to prevent waste, fraud, and abuse with concerns that including all items could have an undue negative effect on practitioners and suppliers. We welcome comment on limiting the associated burden of this proposed rule by refini ng the number of items s ubject to a face-to-face encounter, while still protecti ng the Medicare Trust Funds. In this section of the proposed rule, we describe our propos ed criteria, as well as the

reasons we selected these criter ia. We first note that our pr oposed list of Specified Covered Items contains DME items only. We intend to use future rulemaking to apply section 1834(a)(11)(B)(ii) of the Act to prosthetics and or thotics. We believe th at our proposed current focus on DME items is an appropriate way of ba lancing our goals of reducing waste, fraud, and abuse and limiting burden on beneficiar ies and the supplier community. We propose to focus initially on DME items for several reasons. First, these items are often marketed directly to beneficiaries and requ iring a face-to-face encount er would help ensure that a practitioner has met with the beneficiary and considered whether th e item is appropriate. Additionally, requiring a face-to-face encounter would help ensure that practitioners who order DME items are familiar with the beneficiary' s medical condition, that this condition is documented, and that the item is reasonable a nd necessary. Although we are also concerned about fraud, waste, and abuse asso ciated with prosthetics and pros thetic devices, these items are,

as stated in the Medicare Cl aims Processing Manual Chapter 20 (Section 10.1.2) "devices that replace all or part of an internal body organ or replace all or part of the function of a permanently inoperative or malfunctioning internal body organ." The body member that is being replaced byCMS-1590-P 260

the prosthetic device can often be identified based on previous claims history. We will consider this separately as there may be different burden issues and othe r considerations that apply. Therefore we are not pursuing a face-to-face require ment on these items at this time. Further,

since orthotics are treated in a manner similar to prosthetics for billing and coverage purposes, in order to apply consistent criteria these items will be considered together for future rulemaking. We welcome comment on limiting the associat ed burden of this proposed regulation by refining the number of items subject to a f ace-to-face encounter, while still protecting the Medicare Trust Funds and also 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 recommenda tions from the DME MACs, believe are particularly susceptible to fra ud, waste, and abuse; (4) items determined by CMS as vulnerable to fraud, waste and abuse based on reports of the HHS Office of Inspector General, Government Accountability Office or ot her oversight entities. We are proposing to include items already li sted in the Program Integrity Manual (PIM), Chapter 5, section 5.2.3.1. These items were added to the PIM originally sin ce they were seen as posing vulnerabilities to the Medicare program that could be mitigated through requiring a written order prior to delivery. We believe that requiring a face-to-face encounter is consistent with our previous initiatives and strengthens our efforts to address this vulnerability. We are also proposing to incl ude any items of DME with a price ceiling greater than or equal to $1,000 in the price ceiling column on the DMEPOS Fee Schedule, which is updated annually and lists Medicare allowabl e pricing for DME. We believe that improper claims related to these high dollar items have a greater eff ect on the Medicare Trust Funds based on amountsCMS-1590-P 261

paid by Medicare for these items. Therefore, any items that are $1,000 or greater would be added annually to the list of Specified Covered It ems on a prospective basis. For administrative simplicity we would not annually adjust this valu e for inflation, any changes to this threshold will go through rulemaking. We see this price point as striking a balance between our responsibility to protect the Me dicare Trust Funds and ensuring these requirements do not place

an additional burden on beneficiar ies, practitioners, and suppliers . Our objective is to minimize inappropriate use of high dollar DME items to he lp protect and preserve the Medicare Trust

Funds.

The third criterion added items that we believe, based on our experience and

recommendations from our DME Medicare MACs ar e particularly susceptible to fraud, waste, and abuse. Based on their experience, the DME MACs suggested items that warrant increased practitioner involvement because these items are of ten marketed directly to beneficiaries, thus highlighting the important role of the practitioner in conducting a needs assessment, evaluating, or treating the beneficiary to en sure that his/her condition warra nts the item. The evaluations may assist in ensuring that the DME items ar e medically necessary for the beneficiary. Increasing the practitioner's role in evaluating the beneficiary's n eed for such items, would help ensure proper ordering of DME items, thereby mini mizing the risk of waste, fraud, and abuse. The items recommended by the DME contractors were pressure reducing pads, mattress overlays, mattress, beds, seat lift mechanisms , TENS units, AEDs, external infusion pumps, glucose monitors, wheelchairs and wheelchair ac cessories, nebulizers, negative pressure wound therapy pumps, oxygen and oxygen equipment, pneumatic compression devices, positive airway pressure devices, respiratory assists de vices, and cervical tr action devices.

This criterion was also influenced by our experience with the Health Care Fraud and Prevention and Enforcement Action Teams (HEAT) . These teams were established by HHS andCMS-1590-P 262

the Department of Justice (DOJ) to investigat e, among other things, fraudulent DME suppliers

and have recovered millions of dollars in DME fr aud. The HEAT strike force teams, which are now in nine cities nationwide, have assisted in investigating and pros ecuting DME suppliers who were fraudulently seeking payment for DME items and services. HEAT investigations have resulted in indictments against DME suppliers re lating to the following items: pressure reducing mattresses, oxygen equipment, manual wheelch airs, hospital beds, infusion supplies, and

nebulizers. Further information about DME fraud by State is available at www.stopmedicarefraud.gov

. We are also proposing the inclusion of certa in items of DME on the list of Specified Covered Items because OIG has expressed concer ns (as expressed in DHHS-OIG reports since 1999) that these items are vulnerable to fraud, waste and abuse. These reports detailed

vulnerabilities and called for CMS to address th ese issues. For example, in an OIG Report entitled "Inappropriate Medicare Payments for Pressure Re ducing Support Surfaces" (OEI-02- 07-00420), the OIG noted as a vulnerability the fact that the vast majority of pressure reducing pads that were billed failed to meet the covera ge criteria. Home oxygen therapy was highlighted as a vulnerability in the OIG Report entitle d "Usage and Document ation of Home Oxygen Therapy" (OEI-03-96-00090). Documentation and communication problems associated with negative pressure wound therapy pumps were highlighted in a report titled "Comparison of Prices for Negative Pressure Wound Thera py Pumps" (OEI-02-07-00660). As the OIG explained in that report, " [s] uppliers are required to communicate with the beneficiary's treating clinician to assess wound healing progress and to determine whethe r the beneficiary continues to qualify for Medicare coverage of the pump . . . [S]uppliers re ported not having contact with clinicians for almost one-quart er of the beneficiaries. " Our proposed list of Specified Covered Items is in Table 24 of this proposed rule. WeCMS-1590-P 263

further propose to update this lis t of Specified Covered Items a nnually in order to add any new items that are described by a HCPCS 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 proposed list does not include power mobility devices, which are subject to already existing face-to-face requirements, as prev iously discussed. In addition, we propose 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 disc ontinued HCPCS codes. TABLE 24: DME List of Specified Covered Items HCPCS Code Description E0185 Gel or gel-like pressure mattress pad 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 a nd foot adjustment) with any typeCMS-1590-P 264

HCPCS Code Description 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 system

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 months supply) E0442 Oxygen contents, liquid (1 months supply) E0443 Portable Oxygen contents, gas (1 months supply) E0444 Portable oxygen contents , liquid (1 months supply) E0450 Volume control ventilator wit hout pressure support used withCMS-1590-P 265

HCPCS Code Description 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-electric

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 trunkCMS-1590-P 266

HCPCS Code Description

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. 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 pumpCMS-1590-P 267

HCPCS Code Description 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 rest E0995 Wheelchair accessory calf rest E1002 Wheelchair accessory Power seating system, tilt only

E1003 Wheelchair accessory Power seatin g system, recline only without shear

E1004 Wheelchair accessory Power seating system, recline only with mechanical shear

E1005 Wheelchair accessory Power seating system, recline only with power shear

E1006 Wheelchair accessory Power seating system, tilt and recline without shear

E1007 Wheelchair accessory Power seatin g system, tilt and recline with mechanical shearCMS-1590-P 268

HCPCS Code Description

E1008 Wheelchair accessory Power seatin g system, tilt and recline with power shear

E1010 Wheelchair accessory, addition to po wer seating system, power leg elevation system, including leg rest pair 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 methodsCMS-1590-P 269

HCPCS Code Description E2227 Rigid pediatric wh eelchair ad justable K0001 Standard wheelchair K0002 Standard hemi (low seat) wheelchair K0003 Lightweight wheelchair 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 systemCMS-1590-P 270

c. Physician Payment

We understand that there is a burden associ ated with the requirement placed on the physician to document that a face-to-face encounter has occurred between a PA, a NP or a CNS, and the beneficiary. Accordingly, we are proposi ng the introduction of a G-code, estimated at $15, 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 above. This G-code would become effective when this provision beco mes effective. We believe that the existing Evaluation and Management (E&M) codes are su fficient for practitioners performing face-toface encounters. This new G-code would be specifically designed and mapped only for a physician who completes the documentation of th e face-to-face encounter performed by a PA, a NP, or a CNS. Only a physician who does not b ill an 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 physician can receive the G- code payment only once for documenting that the

face-to-face encounter has occurred. The G-code would be mapped so that only eligible DME items would be covered. Upon request, we will n eed to see documentation of the face-to-face encounter in order to verify the approp riateness of the G-code payment. 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 andCMS-1590-P 271

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 perform 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 propose 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 insteadCMS-1590-P 272

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. E. Ambulance Coverage-Physicia n Certification Statement We propose to revise §410.40(d)(2) by incorpor ating 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 nonemergency, 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 “ambulance service where the us e of other methods of transportation is contraindicated by the individual’s condition, but. . . only to the exte nt provided in regulations.” In other words, the definition of the benefit itself embodies the clinical medical necessity requirement that other forms of transportation must be contraindicated by a beneficiary’s condition. Section 410.40(d) interp rets the medical necessity requirement. Notably, even aside from the requirements of section 1861(s)(7), se ction 1862(a)(1)(A) of the Act dictates that any service that is not medically necessary under the Ac t and regulations is not a covered benefit. Despite these statutory provisi ons and the language of the pr esent regulation at section 410.40(d)(2) that we believe alr eady requires both medical necessi ty 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 inCMS-1590-P 273

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 in particular, but as we mentioned, section 1862(a)(1)(A ) of the Act dictates th at 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 nonemergency, 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 propose 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 “Medic are covers medically necessary nonemergency, 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 secti on are met.” (emphasis added). Although a physician certifie s with respect to medical n ecessity, the Secretary is the final arbiter of whether a service is medically necessary for Medicare coverage. Indeed, the phrase “medically necessary” would have been su rplus had we intended the PCS to be the soleCMS-1590-P 274

determinant of medical necessity. Rather, as dem onstrated by the fact th at we did include that phrase, and by various other clarifying points, we made clear that a PCS, while necessary, does not on its own conclusively 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 physician 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) In light of our acknowledgi ng a significant program vulner ability – that the physicians writing PCSs might not be fully cognizant of the Medicare ambulance benefit’s medicalCMS-1590-P 275

necessity requirements – and encouraging supplier s themselves to help remedy that by educating physicians, it would have been irrational of us to (and we did not) abrogate the Secretary’s judgment and vest exclusively in the PCS the au thority to demonstrate an ambulance transport’s medical necessity. We made a similar point in re sponse to a separate comme nt: “It is always the responsibility of the ambulance supplier to furnish complete and accurate documentation to demonstrate that the ambulance service being furn ished 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 demonstr ate that the transport was medically necessary. The ambulance supplier must meet all coverage criteria for payment to be made.” (67 FR 9100, 9111). Although we incorpor ated that passage into the final rule only at §410.40(d)(3)(v), we intended, and we believe our in tent is clear from the preamble narrative, that the principle apply equally to all nonemergency ambulance transports. The OIG report titled “Medicare Payments 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 conductingCMS-1590-P 276

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 propose to revise §410.40( d)(2) to add nearly the same provision presently found at §410.40(d)(3)(v), except without reference to a “signed return receipt” that does not pertain to nonemergency, scheduled, re petitive ambulance services. We propose to accomplish this by redesignating the current la nguage as §410.40(d)(2)(i), and adding the 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. Rath er, 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 expenses incurred must be reasonable and necessary for the diagnosis or treatment of illness or injury. We also propose to fix the typographical error “fro,” whic h should be “from” in the existing § 410.40(c)(3)(ii).CMS-1590-P 277

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 under section 1848 of the Act. We launched the first phase of the Physician Compare Internet website ( http://www.medicare.gov/find- a-doctor/provi der-search.aspx ) on December 30, 2010. This initial phase included the posting of the names of eligible prof essionals that satisfactorily submitted quality data for the 2009 Physician Qual ity Reporting System, consistent with section 1848(m)(5)(G) of the Act. Since the initial launch of the website , we have continued to build and improve Physician Compare. Currently users can search by selecting a location and specialty for physicians or other healthcare pr ofessionals. Search results provide basic information about approved Medicare providers , such as primary and secondary specialties, practice locations, group practice affiliations, hospital affilia tions, Medicare Assignment, education, languages spoken, and gender. As re quired by section 1848(m)(5)(G) of the Act, we

have added the names of those e ligible professionals who are successful elec tronic prescribers under the Medicare Electronic Prescribing (eRx ) Incentive Program. As such, physician and other healthcare professional profil e pages indicate if professionals satisfactorily participated in the Physician Quality Reporting System and/or are successful electronic prescribers under the eRx Incentive Program based on the most recent data available 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 thanCMS-1590-P 278

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. To the extent that sc ientifically sound measur es 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 Physician Quality Reporting System.

● 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 theCMS-1590-P 279

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 theirCMS-1590-P 280

health care, while encouraging clinicians to impr ove on the quality of care they provide to their patients. In accordance with sec tion 10331 of the Affordable Care Act, we intend to utilize the Physician Compare website 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 Physician Quality Re porting System as an initial step for making physician “measure performance” information public on Physician Compare. By “measure performance” in relation to the Physician Qual ity Reporting System, we mean the percent of times that a particular clinical quality action was reported as being perf ormed, or a particular outcome was attained, for the applicable persons to whom a measure applies as described in the

denominator for the measure. For measures re quiring 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 of th e quality measures that group pr actices submit under the 2012 Physician Quality Reporting System group practice report ing option (GPRO) (76 FR 73417). Therefore, we anticipate, no earlier than 2013, posting performance inform ation collected through the GPRO web interface for group practi ces participating in the Phys ician Quality Reporting System GPRO CY 2012 on Physician Compare. Speci fically, we will make public performance

information for measures included in the 2012 P hysician Quality Reporting System that meet the minimum sample size, and that prove to be statis tically valid and reliable. As we previously established, if the 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 suppressed and not publicly reported. We previously established a minimum threshold of 25 patients for reporting perfor mance information on the Physician Compare website (76 FR 73418). Although we consider ed keeping the threshold for reportingCMS-1590-P 281

performance data on Physician Compare at 25 patients, we propose to change the minimum patient sample size, from 25 patients to 20 patien ts, beginning with data collected for services furnished in 2013, to align with the proposed mini mum patient reporting thresholds for Physician Quality Reporting System measures group reporting for the 2013 and 2014 incentives, and the proposed reliability thresholds for the physicia n value-based payment modifier. We invite comment on the proposed new mini mum patient sample size for Physician Compare, including

whether or not we should retain the existing threshold of 25 patients. Furthermore, in the Shared Savings Program final rule (76 FR 67948) as codified at §425.308, we finalized ACO public reporting provisions in the interest of promoting greater transparency regarding the ACOs participating 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 Physician Quality Reporting System incentive under the Shared Savings Program, we indicated that performance on quality meas ures reported by ACOs at the ACO TIN level, on behalf of their ACO providers /suppliers who are eligib le professionals, using

the GPRO web interface would be reported on Physician Compare in the same way as for the groups that report under the Physician Quality Reporting System. 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 Physician Quality Reporting System

GPRO data. A full website redesi gn is slated for early 2013 to fu rther prepare the site for the introduction of quality data. With each enhancem ent, we work to improve the usability and functionality of the site, provi ding consumers with more tools to help them make informed

healthcare decisions. In CY 2012, we intend to enhance the accuracy of “administrative” information displayedCMS-1590-P 282

on the eligible professional’s prof ile page, and to add additional data. By “administrative” data, we are referring to information about eligible professionals 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 whethe r a physician/other health 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 and the names of those eligible professionals who sa tisfactorily participated under the Physician Quality Reporting System GPRO. We will continue to update the names of those eligible professionals and group practices who satisfactorily participated unde r the Physician Quality Reporting System, and

those who are successful electr onic prescribers under the eRx Incentive Program based on the most recent program year data available. In support of the HHS-wide Milli on Hearts Initiative, we pro pose to post the names of the eligible professionals who re port the Physician Quality Repor ting System Cardiovascular Prevention measures group. This is consistent w ith the requirements unde r section 10331 of the Affordable Care Act to provide information about physicians a nd other eligible professionals who participate in the Physicia n Quality Reporting System. 3. Future Development of Physician Compare Consistent with Affordable Care Act requiremen ts, we intend to phase in an expansion of Physician Compare over the next several years by incorporating quality measures from a variety of sources, if technically feasible. For our ne xt phase, we propose to make public on Physician Compare, performance rates on the quality meas ures that group practi ces submit through the GPRO web interface under the 2013 Physician Quality Reporting System GPRO and the Medicare Shared Savings Program. We anticipate that the 2013 Physician Quality ReportingCMS-1590-P 283

System GPRO web interface measures data w ould be posted no sooner than 2014. This data would include measure performance rates for measures included in the 2013 Physician Quality Reporting System GPRO web interface that meet the proposed minimum sample size of 20 patients, and that prove to be st atistically valid and reliable. When technically feasible, but no earlie r than 2014, we propose to publicly report composite measures that reflect group performance across several related measures. As an initial step we intend to develop disease module level composite scores for Physician Quality Reporting System GPRO measures. Under the Medicare Shared Savings Program, ACOs are required to report on composite measures for Diabetes Mellit us (DM) and Coronary Artery Disease (CAD) (76 FR 67891). Accordingly, in an effort to a lign the PQRS GPRO meas ures with the GPRO measures under the Shared Savings Program, we ha ve proposed in Table 35 of this proposed rule to add composite measures for DM and CAD into the Physician Quality Reporting System starting in 2013. We will also consider future development of composites for the remaining

disease level modules within the GPRO web inte rface. As more data are added to Physician Compare over time, we will consider adding additional disease level composites across measure types as technically feasible and statistically valid. Consistent with the requirement under secti on 10331(a)(2) under the Affordable Care Act to implement a plan to make publically availabl e comparable information on patient experience of care measures, we propose to add patient expe rience survey-based measures such as, but not limited to, the Clinician and Group Consumer Asse ssment of Healthcare Providers and Systems (CG-CAHPS). As discussed in section G.6.c. of this proposed rule, we propose to collect the following patient experience of car e measures for group practices pa rticipating in the Physician Quality Reporting System GPRO;

• CAHPS: Getting Timely Care, Appointments, and InformationCMS-1590-P 284

• 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 propose, no earlier than 2014, to publicly report 2013 patient experience data for all group practices part icipating in the 2013 Physician Quality Reporting System GPRO, not limited to those groups participating via the GPRO web interface, on Physician Compare. At least for 2013, we intend to administer and collect patient experience survey data on a sample of the group practices’ beneficiaries. As we intend to administer and collect the data for these surveys, we do not anticipate any notable burden on the groups. For ACOs participating in th e Shared Savings Program, consistent with the Physician Quality Reporting System proposal to publicly report patient experience measures on Physician Compare starting in 2013, we propose to publicly re port patient experience data in addition to the measure data reported through the GPRO web inte rface. Specifically, the patient experience measures that would be reported for AC Os include the 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 MakingCMS-1590-P 285

For patient experience data reported under either the Physician Quality Reporting System

GPRO or the Medicare Shared Savings Program, we also consid ered an alternative option of providing confidential fee dback to group practices and ACOs using 2013 patient experience data before publicly reporting patient experience data on Physician Co mpare. In lieu of publicly reporting the patient experience data relating to 2013 Physician Quality Reporting System GPRO and ACOs participating in the Shared Savings Pr ogram, we considered using the 2013 results as a baseline to be shared confidentially with th e group practices and ACOs, during which time the group practices and ACOs would have the opport unity to review their data, and implement changes to improve patient expe rience scores. Under this alte rnative option, program year 2014 patient experience data would be the first to be publicly report ed on Physician Compare, and we would publicly report 2014 patient experience data for ACOs and group practices participating in the 2014 Physician Quality Reporting System GP RO on Physician Compare no earlier than 2015. We invite public comment on our proposal to begin publicly reporti ng patient experience data for program year 2013, and also the alternativ e option of delaying pub lic 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 cha nges to the processes used in their practices

based on the review of their da ta from program year 2013. As we continue to improve administrative a nd provider level data, we propose posting the names of those physicians who earned a Physic ian Quality Reporting System Maintenance of Certification Program incentive as data becomes available, but no sooner than 2014. Additionally, we are considering allowing measures that have b een developed and collected by approved and vetted specialty societies to be reported on Physician Compare, as deemed appropriate, and as they are found to be scientifically sound and statistically valid. We propose including additional claims-based process, outcome and resource use measures on PhysicianCMS-1590-P 286

Compare, and intend to align measure selection for Physician Compare with measures selected for the Value Based Modifier (section III.K). As an initial step, we propose to includ e group level ambulatory care sensitive condition admission measures of potentially preventable hospitalizations developed by the HHS Agency for Healthcare Research and Quality (AHRQ) th at 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.ahr q.gov/content.aspx?id=27275). We propose reporting these measures on Physician Compare no earlier than 2015 for those group practices comprised of 2 - 99 eligible professionals participating in th e proposed 2014 physician Quality Reporting System GPRO, and for ACOs. As our ne xt step, we propose to public ly report performance rates on quality measures included in the 2015 Physician Quality Reporting System and value-based payment modifier for individual eligible professi onals. Further details on what measures would be included in the 2015 reporting period will be a ddressed in future rule making. Public reporting of 2015 PQRS and administrative claims-based qua lity measures for individuals would occur no earlier than 2016. For all measures publicly re ported on the Physician Compare website, we propose to post a standard of care, such as t hose endorsed by the National Quality Forum. Such

information will serve as a standard for consum ers to measure individual provider, and group

level data. 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 in formed healthcare decisions. CMS has developed a plan, and started to implement a phased approach to adding quality data to Physician Compare. We believe a staged approach to public reporting of physician info rmation allows for the use of information currently available while we develop the infrastructure necessary to support theCMS-1590-P 287

collection of additional types of measures and pu blic reporting of indivi dual physicians’ quality measure performance results. Implementation of s ubsequent phases of the plan will need to be developed and addressed in future noti ce and comment rulemaking, as needed. We invite comments regarding our proposal s to: (1) reduce the minimum reporting threshold from 25 patients to 20 patients for re porting on Physician Compare; (2) post the names of the eligible professionals w ho report the Physician Quality Reporting System Cardiovascular Prevention measures group for purposes of reco gnition and in support of the Million Hearts Initiative; (3) develop composite measures at the disease module level, initially with CY 2013 GPRO data, and incorporating additional m easures; (4) to publicly report 2013 patient experience data for group practices participati ng in the 2013 Physician Quality Reporting System GPRO, or who are part of an ACO under the Medicare Shared Savings Program, on the Physician Compare website no earlier than 2014 ; (5) the alternativ e option of providing confidential feedback to group practices and ACOs on 2013 patient experience data to allow them to make necessary changes to their proces ses prior to publicly reporting of 2014 patient experience data on Physician Compare; (6) re port names of participants who earn a 2013 Physician Quality Reporting System Maintenance of Certification Prog ram Incentive no earlier than 2014; (7) allow measures that have been developed and collected by specialty societies to be reported on the Physician Compare website as deemed appropriate; (8 ) to report 2014 group level ambulatory care sensitive condition measures of potentially preventable hospitalizations developed by the AHRQ no earlier than 2015 fo r groups participating in the 2014 Physician Quality Reporting System and ACOs, (measure details are available at http://www.qualitymeasures.a hrq.gov/content.aspx?id=27275 ); (9) publicly report performance on 2015 Physician Quality Reporting System a nd value-based payment modifier quality measures for individuals. Public reporting of 2015 Physician Quality Reporting System andCMS-1590-P 288

claims derived quality measures for individuals would occur no earlier th an 2016; and (10) post a standard of care for measures posted on Physicia n Compare. For the above proposals, we note that we would only post data on Physician Compar e if it is technically feasible; the data is available; the system is set up/adjusted to post information and the data is useful, sufficiently reliable, and accurate.CMS-1590-P 289

G. Physician Payment, Efficiency, and Qua lity Improvements – Physician Quality Reporting System

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. CMS believes that this alignment is especi ally critical for programs 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. CMS believes, however, that in order to improve quality, physicians must first engage in quality measurement and reporting. It is CMS's intent that the following proposals will improve alignm ent of physician-focused quality improvement programs, decrease the burden of successful participation on physic ians, increase engagement of physicians in quality improvement, and ultimately lead to higher quality care for beneficiaries. This section contains our proposals related to 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 who satisfactorily report data on quality measur es for covered professional services furnished during a specified reporting period. We note that, in developing these proposals, it was our goal to align program requirements between these quality reporting programs, such as the eRxCMS-1590-P 290

Incentive Program, EHR Incentive Program, Medicar e Shared Savings Program, and value-based payment modifier, wherever possible. We belie ve that alignment of these quality reporting programs will lead to greater overall participatio n in these programs, as well as minimize the reporting burden on eligible professionals. For example, we have aligned the defini tion of group practice under the eRx Incentive Program with PQRS’ definition of group practice. Our proposals with respect to reporting as a group practice for the eRx Incentive Program ar e intended to conform to our proposals for reporting as a group practice for PQRS. With respect to integration with the EH R Incentive Program, section 1848(m)(7) of the Act requires us to develop a plan to integrate reporting on quality measur es under the PQRS with reporting requirements under the EHR Incentive Progr am. We began integrating requirements for these two programs in 2012 with the alignmen t of reporting requirements via the Physician Quality Reporting System-Medicare EHR Incentive Pilot (76 FR 73422) and the alignment of reportable EHR measures (76 FR 73364). Our proposal s in this section are intended to move the PQRS and EHR Incentive Program towards grea ter alignment, benefiting those eligible professionals who wish to participate in both pr ograms. The vision is to report once for multiple programs on a set of measures aligned across pr ograms and with the National Quality Strategy. With respect to integration with the valu e-based payment modifier, we note that we began our efforts to integrate our program requi rements with the value-based payment modifier in the CY 2012 Medicare PFS final rule, when CY 2013 was established as the reporting period for the 2015 PQRS payment adjustment (76 FR 73391) and the initial perf ormance period for the application of the value modifier (76 FR 73435). Our proposals in this section, pa rticularly as they relate to the proposed requirements for satisfactory reporting for the PQRS payment adjustments, are intended to ali gn with the proposals for the app lication of the value modifier.CMS-1590-P 291

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 proposed rule, we are proposing to make technical changes to §414.90 to aid 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 in individual or (2) as part of a group practice participating in the PQRS group practice reporting option (GPRO). a. Participation as an In dividual Eligible Professional (1) Participation for th e 2013 and 2014 Incentives As defined at §414.90(b) the term ‘‘eligible professional’’ means a ny 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 the Physician Quality Reporting System, we refer read ers to the ‘‘List of Eligible Professionals’’

download located in the ‘‘How to Get Started” section of the PQRS CMS Website at http://www.cms.gov/Medicare/Quality -Initiatives-Patient-AssessmentInstruments/PQRS/How _To_Get_Started.html . There is no requirement to self-nominate to participate in PQRS as an indivi dual eligible professional for the incentive or to use the claims, registry, or EHR reporting mechanisms. (2) Proposed Requirement for Eligible Professi onals and Group Practices Electing to Use the Administrative Claims-based Reporting Mech anism for the 2015 and 2016 Payment AdjustmentsCMS-1590-P 292

Unlike using the traditional PQRS reporting mechanisms (claims, registry, EHRs) to satisfy the reporting requiremen ts for the 2015 and 2016 payment adjustments, we propose that eligible professionals and group practices wishing to use the administrative claims reporting mechanism, which is discussed in section K, and available for the 2015 and/or 2016 payment adjustments, must elect to use the administra tive claims reporting mechanism (please note that since the same proposed requirements would apply to both individual eligib le professionals and group practices, we address both in this discussion). We believe this election requirement is necessary because CMS must be notified that CMS must analyze and calculate data from an eligible professional or group prac tice’s claims. This election requirement is not necessary for eligible professionals and group practices using traditional PQRS reporting mechanisms because, for these traditional reporting mechanisms, CMS is not involved with analyzing claims data to determine whether a clinical quality action related to a quality measure was performed. For eligible professionals, we propose that this election proce ss would consist of a registration statement that includes: the eligib le professional’s name and practice name, the eligible professional’s TIN and NPI for analytic al purposes, and the eligible professional’s contact information. For group practices, we pr opose that this electi on process would also consist of a registration statement that include s: the group practice’s business name and contact information, the group practice’s TIN, and contact information of the group practice’s contact(s) who will be contacted for program, clinical, and/ or technical purposes. With respect to the method of submitting this registration statement, we propose the following options:

- If technically feasible, submission of this statement via the web and

- If technically feasible, submission of an eligib le professional’s or gr oup practice’s intent to register to use the administrative claims-b ased reporting mechanism by placing a G-code on

at least 1 Medicare Part B claim.CMS-1590-P 293

In the event the two proposed op tions are not technically feasible , we also considered allowing for submission of the registration statement by submitting a mailed letter to CMS at 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 21244-1850a. However, we note that using this mailing option would be a more burdensome and time-intensive process for CMS. We inv ite public comment on this considered option. 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, 2015 for the 2015 payment adjustment). However, we note that we propose that we may extend this

deadline based on the submission method that is finalized. For example, because processing mailed letters would take the longest to process (out of the 3 met hods), we anticipate 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 anticipate 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-based 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 propose that th ese group practices would use the 2 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 paym ent adjustment. In the alternative, we propose that a group practice participa ting in the GPRO would be re quired to elect to use theCMS-1590-P 294

administrative claims-based reporting mechanism in its self-nomination statement. We are proposing to provide less time for group practices to elect to use the administrative claims-based reporting mechanism because it is necessary for CMS to receive this information in the beginning of the applicable re porting 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 ma y have hundreds or thousands of eligible professionals to track as a group practice. Therefor e, we feel it is approp riate to request that a group practice elect to use the administrative claims-based reporting mechanism when the group practice self-nominates. We further propose that an eligible profe ssional 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 invite 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. b. Participation as a Group Practice in the GPRO (1) Proposed Definition of Group Practice We propose to modify §414.90(b) to define gr oup practice as “a sing le Tax Identification Number (TIN) with 2 or more e ligible professionals, as identif ied by their individual National Provider (NPI), who have reassigned their Me dicare billing rights to the TIN.” We are proposing to change the number of eligible professionals comprisi ng a PQRS group practiceCMS-1590-P 295

from 25 or more to 2 or more to allow all groups of smaller sizes to participate in the GPRO. We believe that expanding the scope of group practices eligible to participate under the program will lead to greater program participation. To pa rticipate in the GPRO, a group practice would be required to meet this proposed definition at all times during the reporting period for the program year in which the group practice is selected to participate in the GPRO. We invite public comment on the proposed definition of group practice. (2) Proposed Election Requirement for Group Practi ces Selected to Participate in the GPRO We established the process for group practices to be selected to participate in the GPRO in the CY 2012 PFS final rule with comment pe riod (76 FR 73316). However, this section contains additional processes with respect to a group practice’s self-nomination statement that we are proposing for group practices selected to participate in the GPRO for 2013 and beyond. With respect to the requirement that group practices wishing to pa rticipate in the GPRO submit a self-nomination statement (76 FR 73316), for 2012, we accepted these self-nomination statements via a letter accompanied by an electronic file submitted in a format specified by CMS because it was not operationally feasible to receive self-nomination statements via the web at that time. In the CY 2012 Medicare PFS final rule with comment period, we noted that we anticipated that CMS would have the ability to co llect self-nomination statements via the web for the 2013 Physician Quality Reporting System. We are therefore proposing that, for 2013 and beyond, a group practice must submit its self -nomination statement via the web. We note that this web-based functionality is still being developed by CMS. Therefore, in the event this web-based functionality would not be available in time to accept self-nomination statements for the 2013 Physician Quality Repor ting System, we propose that, in lieu of submitting self-nomination statements via the we b, a group practice would be required to submit its self-nomination statement via a letter accompan ied by an electronic file submitted in a formatCMS-1590-P 296

specified by CMS (such as a Microsoft excel f ile). We propose that this self-nomination statement would be mailed to the following addre ss: Centers for Medicare & Medicaid Services, Office of Clinical Standards and Quality, Qual ity Measurement and Health Assessment Group, 7500 Security Boulevard, Mail Stop S3-02-01, Ba ltimore, MD 21244-1850. Ifmailing the selfnomination statement, we would require that this self-nomina tion statement be received by no

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.

In the CY 2012 Medicare PFS final rule with comment period, we al so established what information is required to be included in a group practice’s self-nomin ation statement (76 FR 73316). In previous years, the group practice only had one reporting mechanism available on which to report data on PQRS quality measures : the GPRO web-interface. However, beginning 2013, we are proposing to allow gr oup practices to report data on quality measures using the claims, registry, and EHR-based reporting m echanisms for the PQRS incentive and payment adjustment. Additionally, we are proposing to allow group practices to use the proposed administrative claims reporting option. We propos e 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 th e applicable reporting period in it s self-nomination statement. Furthermore, once a group practice is selected to participate in the GPRO and indicates which reporting mechanism the group practice would use, we propose that the group practice would not be allowed to change its selection. Therefore, under this proposal, the reporting mechanism the group practice indicates it will us e in its self-nominat ion statement for the applicable reporting period would be the only reporting mechanism under which CMS will analyze the group practice to determine whether the group practice has met the criteria for satisfactory reporting for the PQRS incentive and/or payment adjustment. We acknowledge that this proposal would departCMS-1590-P 297

from the way we analyze an individual eligible professional, as CMS analyzes an individual eligible professional (who is permitted to use multiple reporting mechanisms during a reporting period) under every reporting met hod the eligible professional us es. 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 practices using the GPRO to use multiple reporting mechanisms or switch reporting mechanisms during the reporting period. We invite public comment on the proposed election requirement and the proposed restriction noted above for group practices under the GP RO for 2013 and beyond. (3) Proposed GPRO Selection Process Group practices must be selected by CMS to participate in the PQRS GPRO for a program year. Please note that if a group practice is selected to participate in the PQRS as a GPRO, the eligible professionals in the selected group practice cannot participate in the PQRS individually. When selecting gr oup practices to participate in the GPRO, CMS bases its decision on the information the group practice provides in its self-nomination statement. We believe that changes in a group practice’s size or TIN constitute such a si gnificant change in the group practice’s composition that it would cause CMS to reconsider its deci sion to allow the group practice to participate in the GP RO for the applicable program year. Specifically, we understand that a group practice’s size may vary throughout th e program year. For example, we understand that eligible professionals ente r into and leave group practices th roughout the year. Similarly, we understand that group practices may undergo busine ss reorganizations during the program year. We note that size fluctuations may affect the criteria under which a group practice would use to report after being selected to pa rticipate in the GPRO. As indi cated in section III.G.4., we are proposing that groups of varying si zes be subject to different crit eria for satisfactory reporting for the 2013 and 2014 incentives, as well as for the paym ent adjustments. Therefore, we proposeCMS-1590-P 298

that, for analysis purposes, the size of the group practice must be established at the time the group practice is selected to pa rticipate in the GPRO. We invite public comment on this proposal. We also understand that, for va rious reasons, a group practice may change TINs within a program year. For example, a group practice ma y undergo a mid-year reor ganization that leads to the group practice changing its TIN mid-year. We propose that, if a group practice changes its TIN after the group practice is se lected to participate in th e GPRO, the group practice cannot continue participate in PQRS as a GPRO. We consider the changing of a group practice’s TIN a significant change to the makeup of the group pr actice, as the group prac tice is evaluated under the TIN the group practice provided to CMS at the tim e the group is selected to participate in the GPRO for the applicable year. Therefore, we view a group practice that changes its TIN as an entirely new practice, associated with a new TI N. We understand that this proposal may pose a disadvantage for those group practices who find it beneficial to report PQRS quality measures using the GPRO. However, we note that eligib le professionals in a group practice that has changed its TIN within a year may still participat e as individuals. We invite public comment on this proposal. We understand that a group practice may decide not to participate in PQRS using the GPRO after being selected. Therefore, we propo se that group practices be provided with an opportunity to opt out of participa tion in the GPRO after selection. We note that it is necessary for a group practice to indicate to CMS the group practices’ intent not to use the GPRO because, once a group practice is selected to participate in the GPRO for the applicable reporting period, CMS will not separately assess the NPIs associated with the group practice’s TIN to see if they meet the criteria for satisfactory reporting for individual eligible professional s. Therefore, CMS must be notified of the group prac tice’s decision not to participate in the GPRO so the eligibleCMS-1590-P 299

professionals within the group practice could be assessed at the individual TIN/NPI level. We propose that group practices have un til April 1 of the year of the applicable reporting period (for example, by April 1, 2013 for reporting periods occurr ing in 2013) to opt out of participating in the GPRO. We invite public comment on the proposed selection pro cess for group practices wishing to participate in the GPRO. (4) Proposed Requirement for Gr oup Practices Electing to Use th e Administrative Claims-based Reporting Mechanism for 2015 and 2016 Payment Adjustments We propose an election requirement for group pr actices that elect to participate in the PQRS for the 2015 and 2016 payment adjustment using administrative claims-based reporting mechanism, which is discussed in full in se ction III.G.5. (which al so addresses election requirements for eligible professionals). We seek comment on our proposal on election requirements for group practices that intend to report using the proposed administrative claims reporting option for the 2015 and 2016 payment adjustment. 2. Proposed Reporting Periods for the PQRS Payment Adjustments for 2016 and Beyond 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) with respect to a paymen t adjustment year. We propose to modify the regulation to establish the reporting periods for the PQRS payment adjustments for 2015 and beyond. For the 2015 payment adjustment, in th e CY 2012 Medicare PFS final rule, we established CY 2013 (that is, January 1, 2013 through December 31, 2013) as the reporting period for the 2015 payment adjustment (76 FR 73392). We established a 12-month reporting period occurring 2 years prior to the application of the payment adjustments for group practices and for individual eligible professionals to allow time to perf orm all reporting analysis prior toCMS-1590-P 300

applying payment adjustments on eligible profes sionals’ Medicare Part B PFS claims. However, we note that we might specify additional repor ting periods for the 2015 payment adjustment. To coincide with the 6-month reporting period asso ciated with the 2013 incentive for the reporting of measures groups via registry, we propose to modify the regulation at newly designated §414.90(h) to add a 6-month reporting peri od occurring July 1, 2013—December 31, 2013, for the 2015 payment adjustment for the reporti ng of measures groups via registry. For 2016 payment adjustments, to coincide with the reporting periods for the 2014 incentive, we propose to modify the regulation at newly designated §414.90(h) to specify a 12- month (January 1, 2014 – December 31, 2014) and, for individual eligible professionals reporting measures groups via registry only, a 6-month (July 1, 2014—December 31, 2014) reporting periods for the 2016 payment adjustments. We believe that data on quality measures collected based on 12-months provides a more accurate assessment of actions performed in a clin ical setting than data collected based on a 6- month reporting period. Therefore, it is our intention to move towards using solely a 12-month reporting period once the reporting periods for the 2013 and 2014 incentives conclude. Therefore, for payment adjustments occurri ng in 2017 and beyond, we propose to modify the regulation at newly designated §414.90(h) to sp ecify only a 12-month reporting period occurring January 1—December 31, that falls 2 years prior to the applicability of the respective payment adjustment (for example, January 1, 2015 through December 31, 2015, for the 2017 payment adjustment). We invite public comment on the proposed reporting periods for the PQRS payment adjustments for 2015 and beyond. 3. Proposed Requirements for the PQRS Reporting Mechanisms 3. Proposed Requirements for the PQRS Reporting Mechanisms This section contains our proposals for the following reporting mechanisms: claims,CMS-1590-P 301

registry, EHR (including dire ct EHR products and EHR data submission vendor products), GPRO web-interface, and administ rative claims. We previously established at §414.90(f)(2) that eligible professionals reporti ng individually may use the clai ms, registry, and EHR-based reporting mechanisms. We propose to modify §414.90 to allow group practices comprised of 2- 99 eligible professionals to us e the claims, registry, and EHR- based reporting mechanisms as well, because we recognize the need to provide varied reporting criteria for smaller group practices, particularly since we are proposing to expand the definition of group practice. For example, we understand that a smaller group practi ce may not have a sufficiently varied practice to be able to meet the proposed satisfactory repo rting criteria for the GPRO web-interface that would require a smaller group practice to report on all of the proposed PQRS quality measures specified in Table 35. These proposals are refl ected in our proposed changes to §414.90, which we are proposing to re-designate §414.90(g) a nd §414.90(h). We invite p ublic comment on this proposal to make the claims, re gistry, and EHR-based reporti ng options applicable to group practices. a. Claims-based Reporting: Proposed Require ments for Using Claims-based Reporting for 2013 and Beyond 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 codes (QDCs) on claims to CMS for analysis. QDCs for the eligible professional's or group practice’s selected PQRS (individual or measur es 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 1 848(m)(1)(A) of the Act, al l claims for services furnished during the reporting peri od, would need to be processed by no later than the last Friday occurring two months after the e nd of the reporting peri od, to be included in the program year'sCMS-1590-P 302

PQRS analysis. For example, all claims for services furnished during a reporting period that occurs during calendar year 2013 woul d need to be processed by no la ter than the last Friday of

the second month after the end of the reporting period, that is , processed by February 28, 2014 for the reporting periods that end December 31, 2013. In addition, after a claim has been submitted and processed, we propose at re-des ignated §414.90(g)(2)(i)(A) and newly added §414.90(h)(2)(i)(A) to indicate that EPs cannot su bmit QDCs on claims that were previously submitted and processed (for example, for the sole purpose of adding a QDC for the PQRS). We invite public comment on our proposed require ments for using the claims-based reporting mechanism for the incentives and for the payment adjustments for 2013 and beyond. b. Registry-based Reporting (1) Proposed Qualification Requirements for Registries for 2013 and Beyond For 2013 and beyond, we propose that registries wishing to submit data on PQRS quality measures for a particular reporting period would be required to be qualified for each reporting period the registries wish to submit quality m easures data. This qua lification process is necessary to verify that registries are able to submit data on PQRS quality measures on behalf of eligible professionals and group pr actices to CMS. Registries w ho wish to become qualified to report PQRS quality measures for a reporting pe riod undergo (1) a self-nomination process and (2) a qualification process regard less of whether the registry wa s qualified the previous program

year. For the self-nomination process, we propos e that the self-nomination process would consist of the submission of a self-nomination statement submitted via the web by January 31 of each year in which the registry seeks to subm it data on PQRS quality measures on behalf of eligible professionals and group pr actices. 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 forCMS-1590-P 303

the 2013 incentive and the 2015 payment adjustme nt, would be required to submit its selfnomination statement by January 31, 2013. We pr opose that the self-nomination statement contain all 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 note 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,

in the event that it is not techni cally feasible to collect this self-nomination statement via the web, we propose that registry vendors would subm it its self-nomination statement via a mailed

letter to CMS. The self-nomination statement would be mailed to the following address: 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 propose that these se lf-nomination statements must be received by CMS by 5:00 Eastern Standard Time on January 31 of the applicable year. For the qualification process, we propose that all registries, regardless of whether or not they have been qualified to re port PQRS quality measures in a prior program year, undergo a qualification process to verify that the registry is prepared to submit data on PQRS quality measures for the reporting period in which the re gistry seeks to be qualified. To become qualified for a particular reporting period, we pr opose 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).CMS-1590-P 304

● 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 all 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 propose to require that qualified registries provide at least 1 feedback report to all participating eligible professionals and group prac tices, we encourage 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, aCMS-1590-P 305

registry wishing to be qualified for reporting in 2013 would be required to participate in all mandatory support conference calls hosted by CMS related 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 denominator specifications) for each measure on which the el igible professional or group practice (as identified by the TIN/NPI) repo rts and/or, upon request, the Medica re 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 id entity management system specified by CMS orCMS-1590-P 306

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 would be required to be submitted to CMS by March 31, 2013). A validation strategy details how the registry will determin e 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 to 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 CMSCMS-1590-P 307

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 data 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 forCMS-1590-P 308

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 propose that these registries, regardless of whether or not registries were qualified in previous years, would be required to:

● 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 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 the year in which the re porting 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 the Summer 2013. Fo r each reporting period, the list of qualified registries would contain the following inform ation: the registry name, registry contactCMS-1590-P 309

information, the measures and/or measures group(s) the registry is qualified and intends to report for the respective reporting period. This proposed registry qualific ation process is largely the sa me process we established to qualify registries for the reporti ng periods occurring in 2012. We are proposing a similar process to the 2012 qualification process because, registri es are already familiar with this qualification process, so we believe there w ould be a greater likeli hood that registries wishing to be qualified to report quality measures data for a particular reporting period would be able to pass the qualification process. We believe this will provide eligible professional with more qualified registry products from which to choose. 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 process but noted the importance of such a process, as well as our intention to provide detailed information regarding a disqualification proces s in future rulemaking (76 FR 73322). In an effort to ensure that registries provide accurate reporting of quality meas ures data, we propose to modify §414.90 to indicate that we would audit qualified registries. If, during the audit process, we find that a qualified registry has submitted grossly inaccurate data, we propose, under §414.90, to indicate that we would disqualify such a registry from the subsequent 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 for the next year. Under this proposal, a disqualified registry woul d not be included in the list of qualified registries that is posted for the applicable reporting periods under which the registry attempted to qualify. For example, if a qualified registry submits quality measures data for the reporting periods occurring in 2013 but is then audited and later disqualified, the registry would not be allowed to submit PQRS quality measures data on behalf of par ticipating eligible professionals and group practices to CMS forCMS-1590-P 310

the reporting periods occurring in 2014 or later. One example of subm itting grossly inaccurate data that CMS has encountered in the past is if a registry reports inaccurate TIN/NPIs on 5 percent or more of the registry’s submission. As CMS calculates data on a TIN/NPI level, it is important for registries to provi de correct TIN/NPI information. We invite public comment as to the threshold of grossly inaccurate data for the purpose of disqualifying a registry. Under our proposal, our decision to disqualify would be final. We further propose to post a registry’s disqualification st atus on the CMS Website at https://www.cms.gov/Medicare/Qual ity-Initiatives-Patient-AssessmentInstruments/PQRS/index.html

. In proposing registry disqualification, we cons idered other alternatives, such as placing registries in a probationary status . However, we believe 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. We invite public comment on our proposal s regarding registry qualification and disqualification for 2013 and beyond. In addition, the Nationwide Health Informa tion Network (NwHIN) is an initiative developed by the Department of Health and Huma n Services that provides for the exchange of healthcare information. Traditionally, CMS has not collected data received via a registry through NwHIN. However, we strive to encourage the collecti on of data via the NwHI N and intend to do so when it is technically feasible to do so (as early as 2014). Th erefore, we seek public comment on collecting data via registry for PQRS via NwHIN. c. EHR-based Reporting (1) Proposed Requirements for a Vendor’s Direct EHR Products for 2014 and BeyondCMS-1590-P 311

We are proposing to modify §414.90(b) to define a direct electronic health record (EHR) product as “an electronic heal th record vendor’s product and version that submits data on Physician Quality Reporting System measures dir ectly to CMS.” Please note that the selfnomination and qualification requi rements for a vendor’s direct EHR products for 2012 and 2013

were established in the CY 2012 Medi care PFS final rule (76 FR 73323). In lieu of continuing this pr ocess in future years of the program, we propose to no longer require qualification of EHR products in orde r to be used for reporting under the PQRS. Although we would still allow EHR vendors to subm it test files to the PQRS and continue to provide support calls, we woul d no longer require vendors to unde rgo this testing process. Although vendors and their products would no longer be required to undergo this testing or qualification process, we propose that CMS w ould 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 testing) through an identity management system specified by CMS or another approved method. In addition, upon request and for oversight pu rposes, we propose that the vendor would still be expected to provide CMS access to review the Medicare beneficiary data on which PQRS

direct EHR-based submissions ar e founded or provide to CMS a copy of the actual data. CMS, however, would no longer be posting a list of qualified EHR vendors and their products on the CMS website. Therefore, eligible professionals would need to work w ith their respective EHR vendor to determine whether their specific EH R product has undergone any testing with the PQRS and/or whether their EHR product can produce and transmit the data in the CMS-specified format and manner. While we no longer believe th at this process is necessary, we invite publicCMS-1590-P 312

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 are proposing to not to continue the qualification requiremen t (that is, no longer propose this process for future years of the progr am) because we believe adequate checks are in place to ensure that a direct EHR product is able to submit quality measures data for the PQRS. For example, to the extent possible, we in tend to align with the Medicare EHR Incentive Program with respect to our criteria for sa tisfactory reporting and measures available for reporting under the EHR-based reporting mechan ism. The Medicare EHR Incentive Program requires that a vendor’s EHR syst em be certified under the program established by the Office of

the National Coordinator for Health Informati on Technology (ONC). In future years, we anticipate that the ONC certificati on process could include testing re lated to the reporting of the proposed PQRS EHR measures indicated in Tabl es 32 and 33, since we are proposing to align the PQRS EHR-based measures with the m easures available for reporting under the EHR Incentive Program. We invite public 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 reporting period be classified as certified under the program established by ONC. Please note that, regardless of whether the qualification process is in place and not withstanding any CEHRT requirements that may a pply, we note that eligible professionals bear the burden of determining choosing a direct EHR pr oduct that is able to adequately submit PQRS quality measures data to CMS. We also invite public comment on the a bove proposals related to the proposed requirements for direct EHR products.CMS-1590-P 313

In addition, the Nationwide Health Informa tion Network (NwHIN) is an initiative developed by the Department of Health and Huma n Services that provides for the exchange of healthcare information. Traditionally, CMS has not collected data received via a direct EHR product through NwHIN, but we would like to encour age this method with EHR-based reporting. However, we strive to encourag e the collection of da ta via the NwHIN and intend to do so when it is technically feasible to do so (as early as 2014). Therefore, we seek public comment on collecting data via an EHR for PQRS via NwHIN. (2) Proposed Requirements for a Vendor’s EHR Data Submission Vendor Products for 2013 and Beyond The EHR data submission vendor reporting mechanism was a mechanism that was newly

established in the CY 2012 Medi care PFS final rule (76 FR 73324). We indicated that these EHR data submission vendors, some of which include d previous registries, we re entities that are able to receive and transmit clinical quality data extracted from an EHR to CMS. We propose to modify §414.90(b) to define an electronic health record (EHR) data submission vendor as “an electronic health record vendor’s pr oduct 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.” Please note that the qualification requir ements for a vendor’s EHR data submission vendor products for 2013 were established in the CY 2012 Medicare PFS final rule (76 FR 73327). Specifically, we establishe d that a qualificati on and testing proces s would occur in 2012 to qualify EHR data submission vendor products to submit PQRS quality measures data for reporting periods occurring in CY 2013. Oper ationally, we were una ble to establish a qualification and testing process in 2012 to qualify EHR data submission vendor products for reporting periods occurring in CY 2013. Theref ore, we propose to perform, in 2013, theCMS-1590-P 314

qualification and testing process established in the CY 2012 Medi care PFS final rule (76 FR 73327) that was supposed to occur in 2012. We invite public comment on this proposal. As for 2014 and beyond, we propose to no l onger qualify EHR data submission vendor products in order to use such pr oducts under the PQRS for the same reasons we have articulated in our proposal not to continue qualifying direct EHR products. Although we would still allow

EHR data submission vendors to submit test files to the PQRS and contin ue to provide support calls, we would no longer require vendors to unde rgo this testing proce ss. Although EHR data submission vendor products would no longer be required to undergo this testing or qualification process, we propose that CMS would onl y 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 vendors who intend to report for purposes of the proposed PQRS Medicare EHR Incentive Program pilot, if the ag gregate data are transmitted in a CMS-approved

XML format

● In compliance with a CMS-specified secure method for data submission. In addition, upon request and for oversight pu rposes, we propose that the vendor would still be expected to provide CMS access to review the Medicare beneficiary data on which PQRS

direct EHR-based submissions ar e founded or provide to CMS a copy of the actual data. CMS, however, would no longer be posting a list of qualified EHR data submission vendors on the CMS website. Therefore, eligible professionals would need to work w ith their respective 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 format and manner. We invite public comment on our proposal to, beginning 2014, not require qualificationCMS-1590-P 315

of EHR data submission vendor products. We al so invite public comment as to whether CMS should continue to require that EHR data submission vendor products undergo these selfnomination and qualification processes prior to be ing authorized to submit quality measure data to CMS on an eligible professional’s behalf for PQRS reporting purposes. We are proposing to not to continue the qualification requiremen t (that is, no longer propose this process for 2014 and future years of the program) because we believe adequate checks are in place to ensure that a direct EHR product is able to submit quality measures data for the PQRS. For example, to the extent possi ble, we intend to align with the Medicare EHR Incentive Program with respect to our criteria for satisfactory reporting and measures available for reporting under the EHR-based reporting mechan ism. The Medicare EHR Incentive Program requires that a vendor’s EHR syst em be certified under the program established by the Office of

the National Coordinator for Health Informati on Technology (ONC). In future years, we anticipate that the ONC certificati on process could include testing re lated to the reporting of the proposed PQRS EHR measures indicated in Tabl es 32 and 33, since we are proposing to align the PQRS EHR-based measures with the m easures available for reporting under the EHR Incentive Program. We invite public comment as to whether, in lieu of qualification, CMS should require that EHR data submission vendor products wishing to submit data on PQRS quality measures for a respective reporting peri od be certified under the program established by

ONC. Please note that, if the qualif ication process is no longer re quired or we do not require that an EHR data submission vendor product be certified under ONC’s program, we note that eligible professionals bear th e burden of determining choosing an EHR data submission vendor product that is able to adequately subm it PQRS quality measures data to CMS. In addition, the Nationwide Health Informa tion Network (NwHIN) is an initiativeCMS-1590-P 316

developed by the Department of Health and Huma n Services that provides for the exchange of healthcare information. Traditionally, CMS has not collected data received via an EHR data submission vendor through NwHIN, but we would like to encourage this method with EHRbased reporting. However, we strive to enc ourage the collection of data via the NwHIN and

intend to do so when it is technical ly feasible to do so (as earl y as 2014). Therefore, we seek public comment on collecting data via an EHR for PQRS via NwHIN. d. GPRO Web-Interface: Proposed Requirement s for Group Practices Using the GPRO WebInterface for 2013 and Beyond

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 propose 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. Consistent w ith the GPRO satisfactor y reporting criteria we established for the 2012 PQRS (76 FR 73338), as well as the GPRO satisfactory reporting criteria we are proposing for 2013 and beyond, we propose to limit reporting via the GPRO webinterface during a respective report ing period to group practices comp rised 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 selected to part icipate in the GPRO for the year under which the reporting period occurs. For example, a group pr actice wishing to submit quality measure data via the GPRO web-interface for 2013 must be a gr oup practice selected to participate in the GPRO for the 2013 program year. We believe itis necessary to limit use of the GPRO webinterface to group practices comprised of at least 25 eligible pr ofessionals selected to participate

in the GPRO because the 17 measures that ar e proposed to be reportable via the GPRO webinterface (as specified in Table 35) reflect a variety of disease modules: patient/ caregiverCMS-1590-P 317

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 these 18 proposed measures spanning across various settings lends this reporting mech anism more ideal for larger group practices that are more likely to be multi-specialty practices (which are typica lly group practices consisting of larger than 25 eligible professionals). The GPRO web-interface was modele d after the CMS Physician Group Practice (PGP) demonstration, and this demonstr ation was originally intended for large group practices. From our experience with the PG P demonstration, we believe a group practice comprised of 25 eligible professionals is the sm allest group practice that could benefit from use of the GPRO web-interface as a reporting mechan ism. We also do not believe that excluding group practices comprised of 2-24 eligible profes sionals from using the GPRO web-interface as a reporting mechanism would harm these smaller group practices as we are proposing to allow groups comprised of 2-99 eligible professionals to report using the cl aims, qualified registry, EHR, and administrative claims-based reporting mechanisms. We propose to provide group practices that are selected to participate in the GPRO using GPRO web-interface reporting op tion with access to the GPRO web-interface by no later than the first quarter of the year following the end of the reporting period under which the group practice intends to report . For example, for group practices selected for the GPRO for the 2013 incentive using the GPRO web-interface tool, we propose to provide group practices selected to participate in the GPRO with access to the GPRO web-interface by no later than the first quarter of 2014 for purposes of reporting for the applicable 2013 reporting period for the incentive. In addition, should CMS encounter op erational issues with using the GPRO web-interface, we reserve the right to use a similar tool for group practices to use in lieu of reporting via the GPROCMS-1590-P 318

web-interface. We invite public comment on our proposed requirements for group practices using the GPRO web-interface for 2013 and beyond. In addition, the Nationwide Health Informa tion Network (NwHIN) is an initiative developed by the Department of Health and Huma n Services that provides for the exchange of healthcare information. Traditionally, CMS has notcollected data received via the GPRO webinterface through NwHIN. 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 seek public comment on collecting data via the GPRO web-interface for PQRS via NwHIN.

e. Administrative Claims For purposes of reporting for the 2015 and 2016 PQRS payment adjustments only, we propose to modify §414.90(h) to allow eligible professionals and group practices to use an administrative claims reporting mechanism. The administrative claims reporting mechanism builds off of the traditional PQRS claims-based reporting mechanism. Under the traditional PQRS claims-based reporting mechanism, eligible professionals and grou p practices wishing to report data on PQRS quality measures via claims for the incentives and for the payment adjustments must submit quality data codes (QDCs) on claims to CMS for analysis. Under the proposed administrative claims reporting mechan ism, unlike the traditional claims-based reporting option, an eligible pr ofessional or group practice w ould not be required to submit QDCs on claims to CMS for analysis. Rather, CMS would analyze every eligible professional’s or group practice’s patient’s Medicare claims to determine whether the eligible professional or group practice has performed any of the clinical quality actions indicated in the proposed PQRS quality measures in Table 63. We propose that , for purposes of assessing claims for quality measures under this option, all claims for servi ces furnished that occurs during the 2015 and/or 2016 PQRS reporting period would need to be processed by no later than 60 days after the end ofCMS-1590-P 319

the respective 2015 and 2016 payment adjustment reporting periods (that is, December 31, 2013 and December 31, 2014). We invite public comment on our proposed requirements for using the administrative claims-based reporting mechan ism for the 2015 and 2016 payment adjustments. 4. Proposed 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 contains our proposed cr iteria for satisfactory reporting for the 2013 and 2014 incentives, which are the last two in centives authorized under the PQRS. a. Proposed Criteria for Satisfactory Repor ting for Individual Eligible Professionals Please note that, in large part , we are proposing many of the same criteria for satisfactory reporting for individual elig ible professionals for the 2013 and 2014 incentives that we established for the 2012 incentive, as eligible professionals are already familiar with these reporting criteria. (1) Proposed Criteria for Satisfactory Reporti ng on Individual 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 tre nd continues, so we anticipate that, with respect to the 2013 a nd 2014 incentives, the criteria fo r satisfactory reporting for the claims-based reporting mechanism will be the met hod most widely used by individual eligibleCMS-1590-P 320

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 propose the following criteria fo r satisfactory reporting of PQRS individual measures for individual e ligible professionals us ing the claims-based reporting mechanism: Report at least 3 measures , 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. Measures with a 0 percent performance rate would not be counted. For an eligible professional who reports fewer than 3 measures via the claims-based reporting mechanism, we propose that the eligible professi onal be subject to the Measures Applicability Validation (MAV) process, which would allow us to determine whether an eligible professional should have reported quality data codes for additional measures. We believe the MAV process is necessary to review whether ther e are other closely related measur es (such as those that share a common diagnosis or those that ar e representative of services t ypically provided by a particular type of eligible 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 incentives. We are proposi ng this MAV process for the claims-based reporting mechanism only because it is more likely for EPs to report on more than 3 measures under the registry and EHR-based reporting mech anisms, as a registry or EHR product willCMS-1590-P 321

typically automatically report on all measures that apply to the eligible pr ofessional’s practice. We note that, consistent with section 1848(m)(3)(A )(i) of the Act, this proposed claims-based reporting criteria is the only pr oposed criteria where an eligible professional may report on fewer than 3 measures. We invite public comment on th e proposed criteria for satisfactory reporting of individual measures by individual eligible professionals via claims for the 2013 and 2014

incentives. (2) Proposed Criteria for Satisfactory Reporti ng on Individual PQRS Quality Measures via Registry In addition, we note that sect ion 1848(m)(3)(A)(ii) of the Ac t provides 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 cr iteria for satisfactory reporting, with respect to registry-based reporting, we have largely 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 PQRS incentive using the satisfactory reporting criteria for the registry-based reporting mechan ism than claims. In fact, in 2010, approximately 87 percent of the eligible professionals reporting individual PQRS quality measures via registry were eligible and met the criteria for satisfactory reporting for the 2010 incentive. Since eligible prof essionals have had success with using these satisfactory reporting criteria, we believe such criter ia are appropriate and see no reas on to change the criteria for satisfactory reporting via registry that has been in place since 2010. Therefore, for those reasons and our desire to maintain the same reporting cr iteria we established for individual eligible professionals for the 2012 PQRS incentive (76 FR 73331), we propose the following criteria forCMS-1590-P 322

satisfactory reporting of PQRS individual measures for individua l eligible professionals using the registry-based reporting mechanism for the 12-month reporting periods for the 2013 and 2014 incentives, respectively: report at least 3 m easures AND report each measure for at least 80 percent of the eligible prof essional’s Medicare Part B FFS pa tients seen during the reporting period to which the measure applies. Measures wi th a zero percent performance rate will not be

counted. Measures with a zero percent performance rate will not be counted. We invite public comment on the proposed criteria for satisfactory reporting of individual measures by individual eligible professionals via a regi stry for the 2013 and 2014 incentives. (3) Proposed Criteria for Satisfactory Reporting on Individual PQRS Quality Measures via EHR As stated previously, section 1848(m)(7) of the Act requires us to develop a plan to integrate reporting requirements for PQRS and the EHR Incentive Program. Therefore, with respect to EHR-based reporting, it is our main goa l to align our EHR repor ting requirements with the reporting requirements an elig ible professional must meet in order to satisfy the clinical quality measure (CQM) component of meaningful use (MU) under the EHR Incentive Program. In the EHR Incentive Program – Stage 2 NPRM (77 FR 13698), we proposed the CQM reporting requirements for the EHR Incentive Program for 2013, 2014, 2015, and potentially subsequent years. For the EHR reporting periods in CY 2013, we proposed (77 FR 13745) to continue the CQM reporting requirements that were establis hed for eligible professionals for CYs 2011 and 2012 in the EHR Incentive Program – Stage 1 fi nal rule (75 FR 44398-44411). Therefore, to align with the reporting requirements for meetin g the CQM component of meaningful use, and based on our authority under secti on 1848(m)(3)(D) of the Act to re vise the reporting criteria for satisfactory reporting identified und er the statute, we propose the following criteria for the 12- month reporting period for the 2013 incentive:CMS-1590-P 323

● 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’ core, altern ate 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 this section. We re fer readers to the discussion in th e Stage 1 final rule for further explanation of the requirements for repor ting 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 the applicable measure for 100 percent of the eligible professionals Medica re Part B FFS patients. In addition, we note 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 cr iteria for satisfactory reporting, for EH R-based reporting, we have largely kept these reporting criteria for the 2010—2012 incen tives. As we have seen some eligible professionals succeed with these criteria, we ar e proposing the following 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. Measures with a zero percent performance rate will not be counted.

We note that the Medicare EHR Incentive Pr ogram has proposed options for meeting the CQM component of achieving meaningful use be ginning with CY 2014 (for more informationCMS-1590-P 324

on these options, please see 77 FR 13746—13748). To align our EHR-based reporting requirements with those proposed under the Me dicare EHR Incentive Prog ram, we are proposing the following criteria for satis factory reporting using the EHR-ba sed reporting mechanism for the 12-month reporting 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 6 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.

● 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 Tables 32 and 33 plus 1 menu clinical quality measure from Tables 32 and 33. It is our intention to finalize the reporting criteria that aligns with the criteria that will be established for meeting the CQM component of meaningful use beginning w ith CY 2014 for the Medicare EHR Incentive Program. Furthermore, to the extent that the final criteria for meeti ng the CQM component of achieving meaningful use differ from what was proposed, our intention is to align with the reporting criteria the EHR Incentive Program ultimately establishes. Therefore, eligible professionals who participate in both PQRS a nd the EHR Incentive Program would be able to use one reporting criterion, dur ing overlapping reporting periods , to satisfy the satisfactory reporting criteria under PQRS and the CQM comp onent of meaningful use under the Medicare EHR Incentive Program. We invite public comment on this considered proposal. In addition to this proposed criterion, the Medicare EHR Incentive Program proposed that, beginning with CY 2014, eligible profession als who participate in both the Physician Quality Reporting System and the Medicare EHR Incentive Program may satisfy the CQMCMS-1590-P 325

component of meaningful use if they subm it and satisfactorily report Physician Quality Reporting System clinical quality measures und er the Physician Quality Reporting System’s EHR reporting option using Certified EHR Tech nology (77 FR 13748). Since this language suggests that the Medicare EHR Incentive Pr ogram may defer to th e satisfactory reporting criteria for the EHR-based reporting mechan ism that we will establish for 2014, we are proposing the following reporti ng criteria for the 12-month reporting period for the 2014 incentive that largely co nform to the criteria set forth unde r section 1848(m)(3)(A )(ii) of the Act

that we established for the 2012 incentive and that we are proposing for the 2013 incentive: report at least 3 measures AND report each meas ure for at least 80 perc ent of the eligible professional’s Medicare Part B FFS patients s een during the reporting period to which the measure applies. Measures with a zero percent performance rate will not be counted. We invite public comment on the proposed criteria for satisf actory reporting on PQRS measures via EHR. (4) Proposed Criteria for Satisfactory Repor ting 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 beCMS-1590-P 326

counted.

We received stakeholder feedback that it is difficult for some specialties to meet the 30 Medicare Part B FF patient threshold. Ther efore, based on our au thority under section 1848(m)(3)(D) of the Act to revi se the reporting criteria for satisfactory reporting, we propose the following criteria for the satisfactory 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 performa nce rate will not be counted. We note that, in an effort to simplify th e satisfactory reporting cr iteria, we are only proposing 1 option for meeting the criteria for satisfactory reporting using PQRS measures groups via claims. We invite public comment on the proposed criterion for satisfactory reporting of measures groups via claims for the 2013 and 2014 incentives. (5) Proposed Criteria for Satisfactory Reporti ng 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 percent 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 groupCMS-1590-P 327

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 FF patient threshold. Ther efore, based on our au thority under section 1848(m)(3)(D) of the Act to revi se the reporting criteria for satisfactory reporting, we propose 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 will not be counted. (2) For the 6-month reporting period for the respective 2013 a nd 2014 incentives, report 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. Please note that this is the same criterion established for the 12-month reporting period. We are proposing the same criterion for both reporting periods in an effort to simplify the reporting criterion for satisfactory reporting.CMS-1590-P 328

We note that, while we still are proposing to re quire that an eligible professional report on at least 20 patients, we understand that a pa tient’s personal identificat ion information may be stripped when data is collected via a qualified registry. As su ch, we understand that it may be difficult to distinguish Medicare and non-Medicare patien ts. Given this difficulty and that the eligible professionals generall y would be attempting to report data on Medicare patients, we believe the reporting of some non-Medicare patients could serve a proxy for the reporting of Medicare patients whose data is not easily di stinguishable as data on Medicare patients under this reporting mechanism. Finally, we note that thes e 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 measures groups and registry-based reporting. We invite public comment on the proposed criteria for sa tisfactory reporting of measures groups by individual eligible professionals via registry for the 2013 and 2014 incentives. Tables 25 and 26 provide a summary of our proposals for the satisfactory reporting of PQRS quality measures for the 2013 and 2014 incentives. Table 25: Proposed Criteria for Satisfactory Re porting by Individual Eligible Professionals of Data on PQRS Quality 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 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;CMS-1590-P 329

Reporting

Period Measure Type Reporting Mechanism Proposed Reporting Criteria

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 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 performance rate will not be counted * Subject to the measure applicability validation (MAV) process. Table 26: Proposed Criteria for Satisfactory Re porting by Individual Eligible Professionals of Data on PQRS quality 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.CMS-1590-P 330

Reporting

Period Measure Type Reporting Mechanism Proposed Reporting Criteria Jan 1, 2014— Dec 31, 2014 Individual Measures Direct EHR product Option 1a: Select and submit 12 clinical quality measures available for EHR-based reporting from Tables 32 and 33, including at least 1 measure from each of the following 6 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. Option 1b: Submit 12 clinical quality measures composed of all 11 of the proposed Medicare EHR Incentive Program core clinical quality measures specified in Tables 32 and 33plus 1 menu clinical quality measure from Tables 32 and 33. Option 2: Report 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. Measures with a zero percent performa nce rate will not be counted. Jan 1, 2014— Dec 31, 2014 Individual Measures EHR data submission vendor Option 1a: Select and submit 12 clinical quality measures available for EHR-based reporting from Tables 32 and 33, including at least 1 measure from each of the following 6 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. Option 1b: Submit 12 clinical quality measures composed of all 11 of the proposed Medicare EHR Incentive Program core clinical quality measures specified in Tables 32 and 33plus 1 menu clinical quality measure from Tables 32 and 33. Option 2: Report 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. Measures with a zero percent performa nce rate will not be counted. 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. Proposed Criteria for Satisfact ory Reporting for Group Practices Se lected to Participate in the

GPRO This section contains our proposed criteria for satisfactory reporting for group practicesCMS-1590-P 331

selected to participate in the GPRO for th e 2013 and 2014 incentives, wh ich are the last two incentives authorized under the Physician Qu ality Reporting System. Please note that, in addition to offering the GPRO web-interface tool that we’ve previously included under the program, we are proposing new criteria for group practices under the GPRO that allow group practices to use the claims, registry, and EHR- based reporting mechanisms. In prior program years, large group practices have been successful in reporting quality measures data via the GPRO web-interface. We are proposing new cr iteria under the claims, qu alified registry, and EHR-based reporting mechanisms because we belie ve that smaller groups may benefit from different reporting criteria a nd also other reporting mechanis ms. Since the introduction of smaller group practices comprised of 25-99 elig ible professionals under the GPRO is fairly recent, and given that we are proposing to modify the definition for group practice such that the PQRS GPRO would include be ginning in 2013 group practices comprised of 2-24 eligible professionals, we are proposing additional criteria for reporting because we believe it may be more practicable that smaller group practices report on PQRS quality measures via claims, qualified registry, or direct EHR or EHR data submission vendor versus the GPRO webinterface, which was designed for use by larger group practices. (1) Proposed Criteria for Beneficiary Assignm ent Methodology and Satisfactory Reporting on PQRS Quality Measures vi a the GPRO Web-Interface In order to populate the GPRO web-interface, we must first assign beneficiaries to each group practice and then from those assigned benefici aries draw a sample of beneficiaries for the

disease modules in the GPRO web interface. This assignment and sampling methodology is

based on what we learned from the PGP dem onstration. The PGP demonstration aims to encourage coordination of the car e furnished to individuals u nder Medicare parts A and B by institutional and other providers, practitioners, and suppliers of h ealth care items and services;CMS-1590-P 332

encourage investment in administrative structur es and processes to ensure efficient service delivery; and reward physicians for improving hea lth outcomes and reducing the rate of growth in health care expenditures. In the PGP Tr ansition demonstration, the goal of beneficiary assignment criteria is to identify Medicare benefi ciaries that have a plurality of their allowed charges for office evaluation and management (E & M) services furnished at a participating PGP during the year. If they do not have any prim ary care physician visits, then they are assigned using plurality of allowed charges for all office E & M physician visits regard less of specialty. In 2012, the beneficiaries that we assigned to group practices, for purposes of reporting on the PQRS quality measures via the GPRO web- interface, were limited to those Medicare Part

B FFS beneficiaries with Medicare Parts A and B claims for whom Medicare is the primary payer. Assigned beneficiaries did not include Medicare Advantage enrollees. We assigned a beneficiary to the group practice if the practice provided the plurality of a beneficiary’s office or other outpatient office evaluation and management allowed charges. Beneficiaries with only one office visit to the group practice were eliminat ed from the group practice’s assigned patient population. Please note that, for the GPRO web- interface, similar to the PGP demonstration, also takes eligible professional services othe r than physician services when evaluating a group practice’s office E & M services. We are pr oposing to continue us ing this assignment methodology for 2013 and subsequent years because it is already in place operationally. We believe the assignment methodology we are currently using adequately captures sufficient data to reflect the quality of care furn ished by group practices reporting under the GPRO web-interface. We invite public comment on our proposal to continue to use this methodology for assigning

beneficiaries. We note that the Medicare Shared Savings Program uses a somewhat different assignment methodology. More information regard ing the assignment methodology that is usedCMS-1590-P 333

in the Shared Savings Program be found on the program website at https://www.cms.gov/Medicare/M edicare-Fee-for-ServicePayment/sharedsavingsprogram/index.html ?redirect=/sharedsavingsprogram/ . However, we note that consistent with the requirements of section 1899(c) of the Act, the assignment methodology used in the Shared Savings Program (whi ch involves a 2-step process) has a greater focus on physician-provided primary care services. In order to more closely align with the Me dicare Shared Savings Program, we considered proposing to modify the assignment method PQRS uses to assign beneficiaries to a group practice to be similar to the two-step assignment method specifi ed in §425.402 that is used under the Medicare Shared Savings Program to assign bene ficiaries 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 must have received at least one pr imary care service from a physician (as defined in §425.20) within the group practice during the reporting 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 care 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 physic ians at any other group practice or non-group practice physician. The second st ep applies only for those benefi ciaries who do not receive any primary care services from a primary care phys ician during the reporting period. We would assign the beneficiary to the partic ipating group practice in this step if the beneficiary had at least one primary care service furnished by a group pr actice physician, regardless of specialty, andCMS-1590-P 334

more primary care services were furnished by group practice profe ssionals (including nonprimary care physicians, nurse prac titioners, physician assistants or clinical nurse specialists) (measured by Medicare allowed charges) at the participating group practice than at any other group practice or non-group practice physician. We would then pull samples of beneficiaries for the relevant measures/modules from this popula tion of assigned beneficiaries to populate the GPRO web interface. We considered making th is change to the assignment method beginning with the 2013 PQRS GPRO web-interface so that the rules used to assign beneficiaries to group practices participating in PQRS and ACOs participating in the Medicare Shared Savings Program would be consistent. Since both group practices that ar e participating in the PQRS GPRO and ACOs participating in the Medicare Shared Savings 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 th e two programs would allow us to streamline our processes and could potentially reduce confusion among group pr actices considering participation in the PQRS GPRO or ACOs cons idering participation in the Medicare Shared Savings Program. We invite public comment on this alternative option of adopting a methodology similar to the one the Medicare Shared Savings Program uses to assign beneficiaries to ACOs to assign beneficiaries to group practices that report on PQRS quality

measures via the GPRO web- interface beginning in 2013. Consistent with the group practice reporting requirements under section 1848(m)(3)(C) of the Act, we propose the following criteria fo r the satisfactory reporting of PQRS quality measures for group practices selected to par ticipate in the GPRO fo r the 12-month reporting periods for the 2013 and 2014 incentives, respec tively, using the 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 assignedCMS-1590-P 335

beneficiaries in the order in which they appear in the group's sample for each disease module or preventive care measure. If the pool of eligib le assigned beneficiaries is less than 218, then report on 100 percent of assigned beneficiaries. In other word s, we understand that, in some instances, the sampling methodology CMS provides 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 propose the follo wing criteria for the satisfactory reporting of PQRS quality measures for group pr actices selected to participat e in the GPRO for the 2013 and 2014 incentives, respectively, using groups practices of 100 or more eligible professionals: Report on all measures included in the web inte rface; AND populate data fi elds 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 criteria we proposed fo r the GPRO web-interface for large group practices for the 2013 and 2014 incentives is consiste nt with the reporting cr iteria we established for the 2012 PQRS incentive (76 FR 73339). The sati sfactory criteria we proposed for groups of 25-99 eligible professionals are consistent with the reporting criteria we established for the 2012 PQRS incentive (76 FR 73339). We are proposing these same criteria because the thresholds proposed in these criteria are based on analysis performed on group reporting based on the PGP

demonstration to determine reasonable thresholds for group practice reporting. Therefore, we believe the satisfactory reporting cr iteria that we have proposed for the GPRO web-interface for the 2013 and 2014 incentives are ap propriate criteria and reas onable for groups to meet. Furthermore, we propose using Medicare Part B claims data for dates of service on orCMS-1590-P 336

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 propose that we woul d assign beneficiaries on which to report based on Medicare Part B claims with dates of service beginning Ja nuary 1, 2013 and processed by October 25, 2013. We invite public comment on our proposal to continue to use this methodology for assigning

beneficiaries. (2) Proposed Criteria for Satisfactory Reporti ng on Individual PQRS Quality Measures for Group Practices Selected to Participate in the GPRO via Claims, Registry, and EHR We are proposing to have the claims, regi stry, and EHR reporting mechanisms available for group practices of 2-99 eligible professionals to use to report PQRS quality measures. We note that we are not proposing to make the claims, registry, and EHR reporting mechanisms available to larger groups of 100 or more eligible professionals, because we believe that these larger group practices do not face the potential limitations that smaller group practices may face when using the GPRO web-interface. Alt hough group practices of 100-249 were also only introduced to the GPRO web-interface in 2012, we note that we believe these practices are sufficiently large enough to account for the vari ed measures required for reporting under the GPRO web-interface. For example, the proposed cr iteria for satisfactory reporting on individual PQRS quality measures for group practices usi ng the GPRO web-interf ace would require a group practice to report on all 18 measur es that are indicated in Tabl e 35. Larger group practices tend to have more varied practices, so it would be easier for larger groups to report on a measure set that covers multiple domains, such as the one proposed in Table 35, than smaller group practices that tend to be focused on a limited set of specialties . We certainly think this is the case for theCMS-1590-P 337

smallest group practices comprised of 2-24 eligib le professionals, which is the reason why we are not proposing that the GPRO web-interface be available for use for these smaller group practices. With respect to group practices compri sed of 25-99 eligible professionals, we believe it is possible for these group practices to have a pract ice that is sufficiently varied to be able to report on measures that cut across multiple domains . However, we note that use of the GPRO web-interface as a reporting mechanism was onl y introduced to groups of 2-99 in 2012, so no data is available to determine the feasibility of groups of 25-99 using th e GPRO web-interface. Therefore, in the event these groups feel that reporting using the GPRO web-interface would be difficult, we are proposing criteria alternative to that proposed under the GPRO web-interface for satisfactory reporting for the 2013 and 2014 incen tives using the claims , registry, and EHRbased reporting mechanisms that mirror the criteria we are propos ing for individual reporting for the claims, registry, and EHR-based reporting mechanisms from the 2013 and 2014 incentives.

We note that the criteria we are proposing for the 2013 and 2014 incentives using the claims, registry, and EHR-based reporting mechanisms are similar to the criteria for individual reporting, because we believe smaller group practices are more akin to individuals w ith respect to practice scope. The larger the group practice, the more likely the group practice would benefit using the reporting options under the GPRO web-interface. Therefore, based on our authority under se ction 1848(m)(3)(C) of the Act, we propose 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 choose to repo rt using a qualified registry, we propose theCMS-1590-P 338

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 Part 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 counte d. Please note that we are only proposing these satisfactory reporting crit eria for group practices comprise d of 2-99 eligible professionals because we believe that larger group practices should have the technical capacity and resources to report on the more expansive measure set that is collected via the GPRO web-interface. For group practices choosing to report PQRS quality measures via EHR, we propose the following 2 options for the satisfactory reporting cr iteria via a direct EH R product or EHR data submission vendor for group practices comprised of 2-99 eligible professionals under 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 meas ures, plus three additional measures. The EHR Incentive Program’ core, alternate core, and addi tional 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 this section. We refer readers to the discussion in the Stag e 1 final rule for furt her explanation of the requirements for eligible professionals repo rting 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 note that the Medicare EHR Incentive Pr ogram has proposed 2 options for meeting the CQM component of achieving meaningful use beginning with CY 2014 (for more information on these options, please see 77 FR 13746—13748). To align our EHR-basedCMS-1590-P 339

reporting requirements with those proposed under the Medicare EHR Incentive Program, we are proposing the following criteria for satisfact ory 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 least 1 measure from each of the following 6 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.

● Option 1b : Submit 12 clinical quality measures composed of all 11 of the proposed Medicare EHR Incentive Program core clinical qua lity measures specified in Tables 32 and 33 plus 1 menu clinical quality measure from Tables 32 and 33. We propose to adopt the group reporting criteria that aligns with the criteria that will be established for meeting the CQM component under CY 2014 for the Medicare EHR Incen tive Program. Furtherm ore, to the extent that the final group reporting crit eria for meeting the CQM com ponent of achieving meaningful use differ from what was proposed, our intention is to align with the group reporting criteria the EHR Incentive Program ultimately establishes. We invite 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: report at least 3 measures, AND report each measure for at least 80 percent of the group practice’s Medica re Part B FFS patients seen during the reporting period to which the measure applies. Measures wi th a zero percent performance rate will not be counted. We invite public commen t on this considered proposal. We note that we believe these proposed criter ia meets the requiremen ts for group practice reporting specified in section 1848 (m)(3)(C) of the Act. Section 1848(m)(3)(C) requires that theCMS-1590-P 340

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 proposed criteria, the group practice decides on which sa mple of patients to report for either 50 percent, 80 percent, or 100 percen t of its patients depending on the reporting mechanism the group practice chooses. For exampl e, if a group practice who sees 100 patients during the 2013 incentive reporting period chooses to report PQRS quality measures using the claims-based reporting mechanism, for the 2013 incentive, the group practice would have to report at least 3 measures for 50 percent of the practice’s patients. The group practice may pick which patients on which to report, as long as the group practice reports on at least 50 of the patients the practice sees in 2013. If the same group practice decides to report on PQRS quality measures using the Option 1 criteria for EHR- based reporting for the 2013 incentive, the group practice would report on all 100 patients. We note that although reporting on 100 percent of patients is not a sample, for data collection pu rposes, CMS would 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 whic h the measure applies, not all of the EHR measures would necessarily apply to all of the group practice’s patients. Since the group practice is then only providing information on its app licable patients, we be lieve the proposed EHR reporting criteria would still meet the statistical sampling model requirement. We invite public comment on the proposed criteria for satisfact ory reporting of indivi dual measures by group practices via claims, registry, or EHR for the 2013 and 2014 incentives. A summary of the proposed crit eria for satisfactory reporting for group practices selectedCMS-1590-P 341

to participate in the GPRO for the 2013 and 2014 incentives is specified in Tables 27 and 28: TABLE 27: Proposed Criteria for Satisfacto ry Reporting 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 WebInterface 25-99 eligible professionals Report on all measures included in the web interface in Table 35; 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 WebInterface 100+ eligible professionals Report on all measures included in the web interface in Table 35; 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)* Claims 2-99 eligible professionals Report at least 3 measures, AND Report each measure for at least 50 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. 12-month (Jan 1 — Dec 31) Qualified Registry 2-99 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. 12-month (Jan 1 — Dec 31) Direct EHR product 2-99 eligible professionals Option 1: Eligible professionals in a group practice must report on three Medicare EHR Incentive Program core or alternate core measures, plus three additiona l measures. The EHR Incentive Program’ core, alternate core, and additional measures can be found in Table 6 of the EHR In centive Program’s Stage 1 final rule (75 FR 44398) or in Tables 32 and 33 of this section. We refer readers to the discussion in the Stage 1 final rule for further explanation of the requirements for eligible professionals for 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 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. 12-month (Jan 1 — Dec 31) EHR data submission vendor 2-99 eligible professionals Option 1: Eligible professionals in a group practice must report on three Medicare EHR Incentive Program core or alternate core measures, plus three additiona l measures. The EHR Incentive Program’ core, alternate core, and additional measures can be found in Table 6 of the EHR In centive Program’s Stage 1 final rule (75 FR 44398) or in Tables 32 and 33 of this section. We refer readers to the discussion in the Stage 1 final rule for further explanation of the requirements for eligible professionals for 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 group practice’s Medicare Part B FF S patients seen during theCMS-1590-P 342

Reporting

Period Reporting Mechanism Group Practice Size Proposed Reporting Criterion 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 28: Proposed Criteria for Satisfacto ry Reporting 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) GPROWebInterface 25-99 eligible professionals Report on all measures included in the web interface in Table 35; 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) GPROWebInterface 100+ eligible professionals Report on all measures included in the web interface in Table 35; 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)* Claims 2-99 eligible professionals 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 reporting period to which the measure applies. Measures with a 0 percent perfor mance rate will not be counted. 12-month (Jan 1 — Dec 31) Qualified Registry 2-99 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 (Jan 1 — Dec 31) Direct EHR product 2-99 eligible professionals Option 1a: Select and submit 12 clinical quality measures available for EHR-based reporting from Tables 32 and 33, including at least 1 measure from each of the followi ng 6 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. Option 1b: Submit 12 clinical quality measures composed of all 11 of the proposed Medicare EHR In centive Program core clinical quality measures specified in Tables 32 and 33 plus 1 menu clinical quality measure from Tables 32 and 33. Option 2: 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 (Jan 1 — Dec 31) EHR data submission vendor 2-99 eligible professionals Option 1a: Select and submit 12 clinical quality measures available for EHR-based reporting from Tables 32 and 33, including at least 1 measure from each of the followi ng 6 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.CMS-1590-P 343

Reporting

Period Reporting Mechanism Group Practice Size Proposed Reporting Criterion

Option 1b: Submit 12 clinical quality measures composed of all 11 of the proposed Medicare EHR In centive Program core clinical quality measures specified in Tables 32 and 33 plus 1 menu clinical quality measure from Tables 32 and 33. Option 2: 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. * Subject to the measure applicab ility validation (MAV) process. c. Proposed Analysis of the Criteria for Sa tisfactory 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 propose that elig ible professionals and group practices may not combine different satisfactory reporting criteria under different reporting mechanisms to meet the requirements of satisfact ory reporting for the 2013 and 2014 in centives. For example, an eligible professional may not meet the re quirements for the 2013 incentive by reporting on 2 applicable PQRS quality measures via claims and 1 applicable PQRS quality measure via qualified registry, because the eligible profession al did not meet the criteria for satisfactory reporting under at least one repor ting mechanism. Similarly, a group practice would be required to select a single reporting m echanism for the entire group practi ce. For example, for a group practice consisting of 4 eligible professionals, th e group practice would not be able to meet the requirements for the 2013 incentive by reporting 2 individual measures vi a claims 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, please note that, alt hough an eligible profe ssional or group practice could meet more than one criterion for satisfactory reporting, only one incentive payment will be made to the eligible professional or group practic e. For example, if an eligible professional meets the criteria for satisfactory reporting of individual measures via claims and measuresCMS-1590-P 344

groups via claims for the 2013 incentive, the e ligible professional w ould nonetheless only be entitled to one incentive payment. CMS would consider the eligible professional to be incentive eligible under whichever reporting criterion yields the greatest bonus. We invite public comment on our proposed analysis of the criteria for satisfactory reporting for the 2013 and 2014

incentives. 5. Proposed 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 propos ed criteria for satisfactory re porting for purposes of the 2015 and 2016 payment adjustments for eligible pr ofessionals 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, in implementing the PQRS payment adjustment, we seek to achieve two overarching policy goals. First, and foremost, we seek to increase participation in the PQRS and to implement the payment adjustment in a manner that will allow eligible professionals who have ne ver participated in the program to familiarize themselves with the program. Second, we seek to align the reportingCMS-1590-P 345

requirements under the PQRS with the quality reporting requirements being proposed for the physician value-based payment modifier discusse d in section III.K of this proposed rule. a. Proposed Criteria for Satis factory Reporting for the 2015 and 2016 Payment Adjustments for Eligible Professionals and Gr oup Practices using the Claims, Registry, EHR, and GPRO webinterface Reporting Mechanisms This section contains our proposals for the criteria for satisfactory reporting for the 2015 and 2016 payment adjustments using the claims, registry, EHR-based, and GPRO web-interface reporting mechanisms. First, we propose that for purposes of the 2015 and 2016 payment adjustments (which would be based on data reported during 12 and 6- month reporting periods that fall within 2013 and 2014, respectively), an eligible professional or group practice would meet the requirement to satisfactorily report da ta on quality measures for covered professional services for the 2015 and 2016 payment adjustment s by meeting the requirement for satisfactory reporting for the 2013 and 2014 incentives respectiv ely. That is, we are proposing the exact same criteria for satisfactory reporting for th e 2015 and 2016 payment adjustments that we are proposing for the 2013 and2014 incentives, described in Tables 25 and 26, with the exception of

one additional alternat ive criterion. Since we have alr eady 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 adjustment s coincide, we believe it is appropriate that the proposed criteria for the 2013 and 2014 respective incentives apply to satisfy the satisfactory reporting requirements for the 2015 and 2016 payment adjustments, respectively. Please note that these proposed criteria fo r the 2013 and 2014 PQRS incentives are the only criteria we are proposing to establish for the respective 2015 and 2016 PQRS payment adjustments for group practices using the GPRO web-interface. With respect to individual eligible professi onals also participating in the EHR IncentiveCMS-1590-P 346

Program, it is our intention to align our proposed criteria for satisfact ory 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, please note that since we are proposing to align our proposed EHR criteri a 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 2014,if these proposals are estab lished and we meet our goal of aligning the two programs, we note that an eligible profe ssional meeting the CQM component of meaningful use during the PQRS 2015 and 2016 payment adjust ment reporting periods using a direct EHR product or EHR data submission vendor that is CE HRT would be able to meet the requirements for satisfactory reporting for the 2015 and 2016 PQRS payment adjustments by submitting a single set of data. As a result of the overarching goals we have articulated above about encouraging participation and concern about eligible profe ssionals’ familiarity and experience with the program, we propose the following alternative cr iteria for satisfactory reporting during the 12- month reporting periods for the 2015 and 2016 paymen t adjustments for eligible professionals and group practices: report 1 measure or measur es group using the claims, registry, or EHRbased reporting mechanisms. We understand that this particular proposed alternative criterion for satisfactory reporting are significantly less stri ngent that the satisfactor y reporting criteria we have proposed for the 2013 and 2014 incentives. Ho wever, we stress that we are proposing less stringent criteria only to ease eligible professiona ls and group practices who have not previously participated in PQRS into reporting. We note th at we are only proposing these criteria for the 2015 and 2016 payment adjustments. As indica ted in section III.G.5.c., for 2017 and beyond, weCMS-1590-P 347

anticipate eliminating th ese alternative proposed criteria a nd establishing criteria that more closely resembles the proposed satisfactory repo rting criteria for the 2013 and 2014 incentives. With respect to group practices, section 1848(m)(3)(C) requires that the criterion for group reporting use a statistical sampling mode l, such as the model used in the PGP demonstration, we note that this proposed repor ting criteria meets this standard, as the group practice would decide on which sample of patient s to report. In these 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 patie nts to which the partic ular measure applied. Please note that, although the group practice may choose the samp le, we anticipate that the sample the group practice selects would represent a sufficient pict ure of the beneficiaries the group practice sees. We invite public comment on the proposed criteria for satisfactory reporting for the 2015 and 2016 payment adjustments for elig ible professionals and group practices using the claims, registry, EHR-based reporting mechanisms. b. Proposed Criteria for Satisf actory Reporting for the 2015 and 2016 Payment Adjustments for Eligible Professionals and Gr oup Practices using the Administ rative Claims-based Reporting

Mechanism (1) Proposed Criteria for Satisfactory Reporti ng for the 2015 and 2016 Payment Adjustments for Eligible Professionals and Gr oup Practices using the Administ rative Claims-based Reporting

Mechanism Unlike the traditional PQRS claims-bas ed reporting mechan ism, the proposed administrative claims-based reporting mechanism does not require an eligible professional to submit quality data codes (QDCs) on Medicare Part B claims. Rather, using the administrative claims-based reporting mechanism only requires th at an eligible profe ssional or group practice submit Medicare claims to CMS. Since CMS, ra ther than the eligible professional or groupCMS-1590-P 348

practice, is performing the analysis and collecting the data provided in an eligible professional’s or group practice’s Medicare claims for an eligible professional’s or group practice’s Medicare beneficiaries, we believe it is a ppropriate to propose a reporting threshold that is more stringent than that proposed for the 2013 and 2014 incentives that use traditional PQRS reporting mechanisms. Therefore, we propose the following criteria for satisfact ory reporting for the 12- month reporting periods for the 2015 and 2016 paymen t adjustments for eligible professionals and group practices using the ad ministrative claims-based reporting mechanism: Report ALL measures in Table 63 for 100 percent of the cases 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 th e PGP demonstration. We note that, although these criteria depart from the model used in the PG P demonstration, similar to our arguments for the satisfactory reporting criteria we are proposing for group practices using the claims, registry, and EHR-based reporting mechanisms, we believe that these criteria 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 unde rstand that, with these proposed criteria, the group practice provides claims data to CMS on 100 pe rcent 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. Theref ore, even though a group practice who sees 100 patients during the applicable PQRS payment ad justment reporting period would report on 100 percent of patients to which the measure applies, not all of the proposed administrative claims measures would necessarily apply to all of the group practice’s patients. Since the group practice is then only providing informati on on its applicable patients, we believe these reporting criteria

would still meet the statistical sampling model requirement. We invite public comment on theseCMS-1590-P 349

proposed criteria. When considering proposals for reporting criteria for the 2015 and 2016 PQRS payment adjustments, we considered satisfactory repor ting options that woul d encourage eligible professionals and group practices to report for the 2013 and/or2014 incentives but, should eligible professionals or group practices come up shy of meeti ng the 2013 and/or 2014 incentive reporting criteria, would still allow an eligible pr ofessional to meet the criteria for satisfactory reporting for the 2015 and/or 2016 payment adjustments. In lieu or more lenient satisfactory reporting criteria we proposed for the 2015 and 2016 payment adjustment, e.g. to report at least 1 measure or measures group or to elect the ad ministrative claims-based reporting option, we considered the option of defaulti ng those eligible professionals who report but fail to meet the criteria for satisfactory reporting using the propo sed criteria for the 2013 and/or 2014 incentives to the administrative claims-based reporting opti on. We would therefore analyze the claims of all eligible professionals who report at le ast 1 measure under a traditional reporting method during the respective 2015 and 2016 payment adjustment reporting periods under the administrative claims-based reporting option. We considered this propo sal because it is our intention to encourage eligible professionals to report PQRS measures using the proposed reporting criteria for the 2013 and 2014 PQRS incen tives. However, given our concern about new eligible professionals’ familiarity and experience with the program, we believe it is necessary to propose an alternat ive, less stringent reporting opti on. We invite public comment on this considered proposal. c. Proposed Analysis of Eligible Professi onals and 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-CMS-1590-P 350

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. We believe this raises issues with regard to the subsequent application of the payment adjustment and concerns about the po tential for abuse (e.g., “gaming the system”). Accordingly, we invite public comment this is sue, including what pa rameters, if any, CMS should impose regarding the changes in TIN/NP Is and compositions of group practices with regard to the payment adjustment. d. Criteria for Satisfactory Reporting for th e Payment Adjustments for 2017 and Beyond for Eligible Professionals and Group Practices We have stressed the importance of allowi ng eligible professiona ls and group practices who are new to the program to gain familiarity with PQRS’s reporting requirements. However, we note that, as we move towards the sole impl ementation of payment adjustments (which would serve as the reporting period for the 2017 payment adju stment), it is our in tention that eligible professionals would be expected to meet reporting criteria th at more closely align to the reporting criteria that we have proposed for the 20 14 incentives above. It is our expectation that in two years' time, eligible professionals w ho are new to PQRS would have enough familiarity with the program that CMS could reasonably ex pect a majority of participating eligible professionals to meet the requireme nts that are identical or very si milar to those that have been required for incentive payment purposes. We in vite public comment on goals for future criteria for satisfactory reporting we ma y require under the program for the 2017 payment adjustment

that are identical or similar to the criteria we have proposed for the 2014 incentive payments.CMS-1590-P 351

We also invite commenters to provide alternative criteria for us to consider in future rulemaking for the payment adjustments for 2017 and beyond. 6. PQRS Quality Measures for 2013 and Beyond a. Statutory Requirements for the Selection of Proposed 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 statutory requirement s, we believe that, except in the circumstances 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 shall 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 aCMS-1590-P 352

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 1890 A of the Act, as amended by adding section 3014 of the Patient Protection and Affordable Care Act (PPACA), requires that the entity with a contract with the Secretary under subsection 1890(a) of the Act (currently that, is the NQF) establish a multi-stakeholder group that would provide for a transparent process for selecting quality measures, such as the quality m easures selected for repo rting under the PQRS.

Pursuant to section 3014 of A ffordable Care Act, the NQF cr eated the Measure Applications Partnership. Section 1890(b)(7 )(B) requires that the Secretar y establish a pre-rulemaking process whereby the multi-stakeholder group will pr ovide input to the Secretary on the selection of quality measures. To receive input from the Measures Applications Partnership, we submitted all the measures we are proposing in this section with the exception of the administrative claims measures that we are incorporating to align with the Value-Based Modifier and the measures that we are incorporating to align w ith the Medicare Shared Savings Program specified in Tables 29 through 62. The list of measures the Measures A pplication Partnership ha ve considered for 2012

are available at http://www.qualityforum.org/Sett ing_Priorities/Partnership/Meas ure_Applications_Partnership.a

spx

. b. Other Considerations for the Selection of Proposed PQRS quality measures for 2013 and BeyondCMS-1590-P 353

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.

● 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 consistent with section 1848(k)(2)(C) of the Act or fell under the exception specified in secti on 1848(k)(2)(C)(ii) of the Act. Although th e deadline to submitCMS-1590-P 354

measures for consideration for the 2013 PQRS program year has ended, we invite public

comment on future considerations related to the selection of new PQRS quality measures. c. Proposed 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: (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 und erstanding of their health 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 patients

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 in order 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 areCMS-1590-P 355

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. 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 our 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 theCMS-1590-P 356

measure. Examples of such changes could be updated diagnosis or procedure codes, changes to exclusions to the patient population, definitions, or extension of the measure endorsement to apply to other settings. We believe these types of maintenance changes are distinct from more substantive changes 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. In this proposed rule, we are proposing th at if the NQF updates an endorsed measure that we have adopted for the PQRS in a manner that we consider to not s ubstantially change the nature of the measure, we would use a subregul atory process to incorpor ate those updates to the measure specifications that apply to the program. Specifically, we would revise the Specifications Manual so that it clearly identifies the updates and provide links to where additional information on the updates can be found. We would also post the updates on the CMS QualityNet Website at https://www.QualityNet.org . We would provide sufficient lead time for [insert applicable party; i.e. hospitals, LTCHs, etc.] to implement 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 proposal adequately balances our need to incorporate NQF updates to NQF – endorsed [insert name of applicable program] measures in the most expeditious manner possible, while preserving the public's ability to comment on updates that so fundamentally change an endorsed measure that it is no longer the same measur e that we originally adopted. We invite public comment on this proposal. 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 measuresCMS-1590-P 357

is available at the PQRS Website at http://www.cms.gov/Medicare/Quality-Initiatives-PatientAssessment-Instruments/PQRS/index.html

. (1) Proposed PQRS Individual Core Measures Available for Claims, Qualified Registry, and EHR-based Reporting for 2013 and Beyond In 2011, the Department of Health and Human Services (HHS) started the Million Hearts Initiative, which is an initiative to prevent 1 milli on heart attacks and strokes in five years. We

are dedicated to this initiative and seek to enco urage eligible professionals to join in this endeavor. Therefore, based on our desire to s upport the Million Hearts initiative and maintain our focus on cardiovascular disease preven tion, we are proposing the following proposed individual PQRS Core Measures specified in Table 29 for 2013 and beyond. Please note that

these measures are the same measures we finalized under the 2012 PQRS in the CY 2012 Medicare PFS final rule (76 FR 73345). TABLE 29: Proposed PQRS Individual Core Measures for 2013 and Beyond 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 in Diabetes Mellitus: 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) 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 NCQA X X X X X HITECH ACO Million HeartsCMS-1590-P 358

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

with ischemic vascular disease (IVD) with documented use of aspirin or other antithrombotic 0028/ 226 Population /Public Health Preventive Care and Screening: Tobacco 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 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 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 X X X X X HITECH ACO Million Hearts

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 CMS/ QIP X HITECH Million HeartsCMS-1590-P 359

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

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 N/A/ 317 Population /Public Health Preventive Care and Screening: Screening for High Blood Pressure: Percentage of patients aged 18 and older who are screened for high blood pressure CMS/ QIP X X X X X HITECH ACO Million Hearts *Measures that can be reported using the GPRO web interface. ¥ Titles and descriptions in this table are aligned with the proposed 2013 Physician Quality Reporting System Electronic Health Records (EHR) measure titles, and may di ffer from existing measures in other programs. Please reference the National Quality Forum (NQF) and Physician Quality Reporting System numbers for clarification.

Please note that, although we are proposing th at the measures in Table 29 serve as core PQRS quality measures, we are not proposing to re quire that eligible professionals report on these proposed PQRS core measures. We inv ite public comment on the proposed PQRS core measures for 2013 and beyond. (2) Proposed PQRS quality measures Available for Reporting via the Claims, Qualified Registry, EHR, and GPRO Web-Interface Repor ting Mechanisms for 2013 and BeyondCMS-1590-P 360

This section contains our proposals for i ndividual PQRS quality measures for 2013 and beyond. Please note that, in large part, we are pro posing to retain most of the quality measures we finalized for reporting for the 2012 PQRS (76 FR 42865 through 42872). However, in 2013 and 2014, we are proposing 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 30 specifies the measures we ar e proposing to be available for reporting under the PQRS for 2013 and beyond. TABLE 30: Proposed PQRS Individual Qua lity Measures Available for Reporting via Claims, Registry, EHR and/or the GPRO We b-Interface for 2013 and Beyond That Were NOT Available for Reporting under the 2012 PQRS Reporting MechanismNQF/PQRS National Quality Strategy Domain Measure Title and Description ¥Measure StewardPQRS ClaimsPQRS Qualified RegistryPQRS Qualified EHRCMS-Selected GPRO(web interface)*Measures GroupsOther Quality ReportingPrograms

TBD / TBD Clinical Process/ Effective ness Stroke and Stroke Rehabilitation:Tissue Plasminogen Activator (tPA) Considered (Paired Measure): Percentage of patients aged 18 years and older with a diagnosis of ischemic stroke who arrive at the hospital within 4.5 hours of time last known well who were considered for t-PA administration AMAPCPI X X

TBD / TBD Clinical Process/ Effective ness Stroke and Stroke Rehabilitation:Tissue Plasminogen Activator (tPA) Administered Initiated (Paired Measure): Percentage of all patients aged 18 years and older with a diagnosis of ischemic stroke who present within two hours of time last known well and who are eligible for t-PA, for whom t-PA was initiated within three hours of time last known AMAPCPI X XCMS-1590-P 361

Reporting MechanismNQF/PQRS National Quality Strategy Domain Measure Title and Description ¥Measure StewardPQRS ClaimsPQRS Qualified RegistryPQRS Qualified EHRCMS-Selected GPRO(web interface)*Measures GroupsOther Quality ReportingPrograms

well 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 Coordina tion Endoscopy and Polyp Surveillance: Appropriate Follow-Up Interval for 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 AMAPCPI X X

0493 / TBD Care Coordina tion Participation by a 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 CMS/ QIP X XCMS-1590-P 362

Reporting MechanismNQF/PQRS National Quality Strategy Domain Measure Title and Description ¥Measure StewardPQRS ClaimsPQRS Qualified RegistryPQRS Qualified EHRCMS-Selected GPRO(web interface)*Measures GroupsOther Quality ReportingPrograms

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 statewide registry is encouraged for this measure. f. Registry may provide feedback directly to the provider’s local registry if one exists 0670 / TBD Efficient Use of Healthca re Resource s Cardiac Stress Imaging Not Meeting Appropriate Use Criteria:Preoperative Evaluative in LowRisk Surgery Patients: Percentage of stress single-photon emission computed tomography (SPECT) myocardial perfusion imaging (MPI), stress echo, cardiac computed tomography angiography (CCTA), or cardiovascular magnetic resonance (CMR) performed in low risk surgery patients for preoperative evaluation ACC X

0671 / TBD Efficient Use of Healthca re Cardiac Stress Imaging Not Meeting Appropriate Use Criteria: Routine Testing After Percutaneous Coronary ACC XCMS-1590-P 363

Reporting MechanismNQF/PQRS National Quality Strategy Domain Measure Title and Description ¥Measure StewardPQRS ClaimsPQRS Qualified RegistryPQRS Qualified EHRCMS-Selected GPRO(web interface)*Measures GroupsOther Quality ReportingPrograms

Resource s Intervention (PCI): Percentage of all stress single-photon emission computed tomography (SPECT) myocardial perfusion imaging (MPI) and stress echo performed routinely after percutaneous cardiology intervention (PCI), with reference to timing of test after PCI and symptom status 0672 / TBD Efficient Use of Healthca re Resource s Cardiac Stress Imaging Not Meeting Appropriate Use Criteria: Testing in Asyptomatic, Low-Risk Patients: Percentage of all stress single-photon emission computed tomography (SPECT) myocardial perfusion imaging (MPI), stress echo, cardiac computed tomography angiography (CCTA), and cardiovascular magnetic resonance (CMR) performed in asymptomatic, low coronary heart disease (CHD) risk patients for intial detection and risk assessment ACC X

TBD / TBD Clinical Process/ Effective ness Adult Major Depressive Disorder: Coordination of Care of Patients with Co-Morbid Conditions - Timely Follow-Up: Percentage of medical records of patients aged 18 years and older with a diagnosis of MDD and a diagnosed co-morbid condition being treated by another physician with communication to theother physician treating the comorbid condition AMAPCPI X

TBD / Care Coordina Coordination of Care of Patients with Co-Morbid Conditions - AMAPCPI XCMS-1590-P 364

Reporting MechanismNQF/PQRS National Quality Strategy Domain Measure Title and Description ¥Measure StewardPQRS ClaimsPQRS Qualified RegistryPQRS Qualified EHRCMS-Selected GPRO(web interface)*Measures GroupsOther Quality ReportingPrograms

TBD tion Timely Follow-Up (Paired Measure): Percentage of medical records of patients aged 18 years and older with a diagnosis of major depressive disorder (MDD) and a diagnosed co-morbid condition with communication to another physician treating the co-morbid condition who have a response from the other physician within 45 days of original communication OR who have a follow-up attempt within 60 days of original communication by the physician treating MDD to elicit a response from the other physician

1525 / TBD Patient Safety Atrial Fibrillation and Atrial Flutter: Chronic Anticoagulation Therapy: Percentage of patients aged 18 and older with nonvalvular AF or atrial flutte r at high risk for thromboembolism, according to CHADS2 risk stratification, who were presecribed warfarin or another oral anticoagulant drug that is FDA approved for the prevention of thromboembolism during the 12- month reporting period AMA X X HITEC H

TBD / TBD Clinical Process/ Effective ness Pediatric End-Stage Renal Disease Measure (AMA/ASPN): 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-st age renal disease AMA/ ASPN X XCMS-1590-P 365

Reporting MechanismNQF/PQRS National Quality Strategy Domain Measure Title and Description ¥Measure StewardPQRS ClaimsPQRS Qualified RegistryPQRS Qualified EHRCMS-Selected GPRO(web interface)*Measures GroupsOther Quality ReportingPrograms

(ESRD) undergoing maintenance hemodialysis in an outpatient dialysis facility have an assessment of the adequacy of volume management from a nephrologist 1667 / TBD Clinical Process/ Effective ness Pediatric Kidney Disease: ESRD Patients Receiving Dialysis: Hemoglobin Level <10g/dL: Percentage of calendar months within a 12-month period during which patients aged 17 years and younger with a diagnosis of ESRD receiving hemodialysis or peritoneal dialysis have a Hemoglobin level <10 g/dL AMA X X

*Measures that can be reported using the GPRO web interface. † These measures can only be reported by participants using the GPRO. They are not available for reporting for individual Eligible Professionals using this reporting method. ¥ Titles and descriptions in this table may differ from existing measures in other programs. Please reference the National Quality Forum (NQF) and PQ RS numbers for clarification. Although we are proposing to add measures th at were not availabl e for reporting under the 2012 PQRS, we note that we are not proposin g to retain certain measures from the 2012 PQRS. For reference, in Table 31 we list 14 measures from the 2012 PQRS that we are not proposing for the 2013 PQRS.CMS-1590-P 366

TABLE 31: Measures Included in the 2012 PQRSs Measure Set that are Not Proposed to be Included in the Physician Quality Repo rting Program Measure Set for 2013 and Beyond Reporting MechanismNQF/PQRS National Quality Strategy Domain Measure Title and Description ¥Measure StewardPQRS ClaimsPQRS Qualified RegistryCMS-Selected EHRCMS-Selected GPRO(web interface)*Measures GroupsOther Quality ReportingPrograms

0246/ 10 Clinical Process/ Effective ness Stroke and Stroke Rehabilitation: Computed Tomography (CT) or Magnetic Resonance Imaging (MRI) Reports: Percentage of final reports for CT or MRI studies of the brain performed either: • In the hospita l within 24 hours of arrival, OR • In an outpatient imaging center to confirm initial diagnosis of stroke, transient ischemic attack (TIA) or intracranial hemorrhage For patients aged 18 years and older with either a diagnosis of ischemic stroke, TIA or intracranial hemorrhage OR at least one documented symptom consistent with ischemic stroke, TIA or intracranial hemorrhage that includes documentation of the presence or absence of each of the following: hemorrhage, mass lesion and acute infarction AMAPCPI/ NCQA X X HITECH

0094/ 57 Clinical Process/ Effective ness Emergency Medicine: Community-Acquired Pneumonia (CAP): Assessment of Oxygen Saturation: Percentage of patients aged 18 years and older with a diagnosis of community-acquired bacterial pneumonia with oxygen saturation documented and reviewed AMAPCPI/ NCQA X X X

0095/ 58 Clinical Process/ Effective Emergency Medicine: Community-Acquired Pneumonia (CAP): Assessment of Mental AMAPCPI/ NCQA X X XCMS-1590-P 367

Reporting MechanismNQF/PQRS National Quality Strategy Domain Measure Title and Description ¥Measure StewardPQRS ClaimsPQRS Qualified RegistryCMS-Selected EHRCMS-Selected GPRO(web interface)*Measures GroupsOther Quality ReportingPrograms

ness Status: Percentage of patients aged 18 years and older with a diagnosis of community-acquired bacterial pneumonia with mental status assessed AQA adopt ed/ 92 Clinical Process/ Effective ness Acute Otitis Externa (AOE): Pain Assessment: Percentage of patient visits for those patients aged 2 years and older with a diagnosis of AOE with assessment for auricular or periauricular pain AMAPCPI X X

0488/ 124 Care Coordina tion Health Information Technology (HIT): Adoption/Use of Electronic Health Records (EHR): Documents whether provider has adopted and is using health information technology. To report this measure, the eligible professional must have adopted and be using a certified, Physician Quality Reporting System qualified or other acceptable EHR system CMS/ QIP X X

0466/ 158 Clinical Process/ Effective ness Carotid Endarterectomy: Use of Patch During Conventional Carotid Endarterectomy: Percentage of patients aged 18 years and older undergoing conventional (non-eversion) carotid endarterectomy (CEA) who undergo patch closure of the arteriotomy SVS X X

AQA adopt ed/ 186 Clinical Process/ Effective ness Chronic Wound Care: Use of Compression System in Patients with Venous Ulcers: Percentage of patients aged 18 years and older with a diagnosis of venous ulcer who were prescribed compression AMAPCPI/ NCQA X XCMS-1590-P 368

Reporting MechanismNQF/PQRS National Quality Strategy Domain Measure Title and Description ¥Measure StewardPQRS ClaimsPQRS Qualified RegistryCMS-Selected EHRCMS-Selected GPRO(web interface)*Measures GroupsOther Quality ReportingPrograms

therapy within the 12-month reporting period N/A/ 189 Care Coordina tion 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 Coordina tion 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

0065/ 196 Clinical Process/ Effective ness Coronary Artery Disease (CAD): Symptom and Activity Assessment: Percentage of patients aged 18 years and older with a diagnosis of coronary artery disease seen within a 12 month period for whom there are documented results of an evaluation of level of activity AMAPCPI/ ACCF /AHA X XCMS-1590-P 369

Reporting MechanismNQF/PQRS National Quality Strategy Domain Measure Title and Description ¥Measure StewardPQRS ClaimsPQRS Qualified RegistryCMS-Selected EHRCMS-Selected GPRO(web interface)*Measures GroupsOther Quality ReportingPrograms

AND an evaluation of presence or absence of anginal symptoms in the medical record 0082/ 199 Clinical Process/ Effective ness Heart Failure: Patient Education: Percentage of patients aged 18 years and older with a diagnosis of heart failure who were provided with patient education on disease management and health behavior changes during one or more visit(s) within 12 months CMS/ QIP X

0447/ 212 Care Coordina tion 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 ASHA X

0017/ 235 Clinical Process/ Effective ness Hypertension (HTN): Plan of Care: Percentage of patient visits for patients aged 18 years and older with a diagnosis of HTN during which either systolic blood pressure ≥ 140 mmHg OR diastolic blood pressure ≥ 90mm Hg, with documented plan of care for hypertension CMS/ QIP X X

0502/ 253 Clinical Process/ Effective ness Pregnancy Test for Female Abdominal Pain Patients: Percentage of female patients aged 14 to 50 who present to the emergency department (ED) with a chief complaint of abdominal pain for whom a pregnancy test ordered ACEP X X

*Measures that can be reported using the GPRO web interface.CMS-1590-P 370

¥ Titles and descriptions in this table are aligned with the proposed 2013 PQRS Electronic Health Records (EHR) measure titles, and may differ from existing measures in other programs. Please reference the National Quality Forum (NQF) and PQRS numb ers for clarification. A summary of the measures we are proposi ng for 2013 and beyond are specified in Table 32. Table 32 specifies our proposals to propose all measures that were available for reporting in PQRS in 2012, with the exception of the measur es listed in Table 31, as well as propose new measures specified in Table 30 not availabl e for reporting under PQ RS in prior years.

TABLE 32: Proposed PQRS Individual Qua lity Measures Available for Reporting via Claims, Registry, EHR, or GRPO Web-Interface for 2013 and Beyond Reporting MechanismNQF/PQRSNew Measure National Quality Strategy Domain Measure Title and Description ¥Measure StewardPQRS ClaimsPQRS Qualified RegistryPQRS Qualified EHRCMS-SelectedGPRO(web interface)*Measures GroupsOther Quality ReportingPrograms

0059/ 1 Clinical Process/ Effectivenes s Diabetes Mellitus: Hemoglobin A1c Poor Control in Diabetes Mellitus: Percentage of patients aged 18 through 75 years with diabetes mellitus who had most recent hemoglobin A1c greater than 9.0% N CQA X X X X X HITE CH ACO

0064/ 2 Clinical Process/ Effectivenes s Diabetes Mellitus: Low Density Lipoprotein (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 control (less than 100 mg/dL) N CQA X X X X HITE CH Millio n Hearts

0061/ 3 Clinical Process/ Effectivenes Diabetes Mellitus: High Blood Pressure Control in Diabetes Mellitus: N CQA X X X X HITE CHCMS-1590-P 371

Reporting MechanismNQF/PQRSNew Measure National Quality Strategy Domain Measure Title and Description ¥Measure StewardPQRS ClaimsPQRS Qualified RegistryPQRS Qualified EHRCMS-SelectedGPRO(web interface)*Measures GroupsOther Quality ReportingPrograms

s Percentage of patients aged 18 through 75 years with diabetes mellitus who had most recent blood pressure in control (less than 140/90 mmHg) 0081/ 5 Clinical Process/ Effectivenes s Heart Failure: Angiotensin-Converting 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 and LVSD (LVEF < 40%) who were prescribed ACE inhibitor or ARB therapy A MAP CPI/ A CCF/A H A X X X HITE CH

0067/ 6 Clinical Process/ Effectivenes s 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 A MAP CPI/ A CCF/A H A X X X X

0070/ 7 Clinical Process/ Effectivenes s Coronary Artery Disease (CAD): Beta-Blocker Therapy for CAD Patients with Prior Myocardial Infarction (MI): Percentage of A MAP CPI/ A CCF/A H A X X HITE CHCMS-1590-P 372

Reporting MechanismNQF/PQRSNew Measure National Quality Strategy Domain Measure Title and Description ¥Measure StewardPQRS ClaimsPQRS Qualified RegistryPQRS Qualified EHRCMS-SelectedGPRO(web interface)*Measures GroupsOther Quality ReportingPrograms

patients aged 18 years and older with a diagnosis of CAD and prior MI whowere prescribed betablocker therapy 0083/ 8 Clinical Process/ Effectivenes s Heart Failure: BetaBlocker 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%) andwho were prescribed betablocker therapy A MAP CPI/ A CCF/A H A X X X X HITE CH ACO

0105/ 9 Clinical Process/ Effectivenes s Anti-depressant medication management: (a) Effective Acute Phase Treatment, (b) Effective Continuation Phase Treatment: The percentage of patients 18 years of age and older who were diagnosed with a new episode of major depression, treated with antidepressant medication, and who remained on an antidepressant medication treatment N CQA X X X HITE CH

0086/ 12 Clinical Process/ Effectivenes s Primary Open Angle Glaucoma (POAG): Optic Nerve Evaluation: Percentage of patients A MAP CPI/ N CQA X X X HITE CHCMS-1590-P 373

Reporting MechanismNQF/PQRSNew Measure National Quality Strategy Domain Measure Title and Description ¥Measure StewardPQRS ClaimsPQRS Qualified RegistryPQRS Qualified EHRCMS-SelectedGPRO(web interface)*Measures GroupsOther Quality ReportingPrograms

aged 18 years and older with a diagnosis of POAG who have an optic nerve head evaluation during one or more office visits within 12 months 0087/ 14 Clinical Process/ Effectivenes s 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 A MAP CPI/ N CQA X X

0088/ 18 Clinical Process/ Effectivenes s 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 A MAP CPI/ N CQA X X X HITE CHCMS-1590-P 374

Reporting MechanismNQF/PQRSNew Measure National Quality Strategy Domain Measure Title and Description ¥Measure StewardPQRS ClaimsPQRS Qualified RegistryPQRS Qualified EHRCMS-SelectedGPRO(web interface)*Measures GroupsOther Quality ReportingPrograms

documentation of the level of severity of retinopathy and the presence or absence of macular edema during one or more office visits within 12 months 0089/ 19 Clinical Process/ Effectivenes s Diabetic Retinopathy: Communication with thePhysician 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 on-going care of the patient with diabetes mellitus regarding the findings of the macular or fundus exam at least once within 12 months A MAP CPI/ N CQA X X X HITE CH

0270/ 20 Patient Safety Perioperative Care: Timing of Antibiotic 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 A MAP CPI/ N CQA X X XCMS-1590-P 375

Reporting MechanismNQF/PQRSNew Measure National Quality Strategy Domain Measure Title and Description ¥Measure StewardPQRS ClaimsPQRS Qualified RegistryPQRS Qualified EHRCMS-SelectedGPRO(web interface)*Measures GroupsOther Quality ReportingPrograms

parenteral antibiotic to be given within one hour (if fluoroquinolone or vancomycin, two hours), prior to the surgical incision (or start of procedure when no incision is required) 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 A MAP CPI/ N CQA X X X

0271/ 22 Patient Safety Perioperative Care: Discontinuation of Prophylactic Antibiotics (Non-Cardiac Procedures): Percentage of non-cardiac surgical patients aged 18 years and older undergoing procedures with the indications for prophylactic parenteral A MAP CPI/ N CQA X X XCMS-1590-P 376

Reporting MechanismNQF/PQRSNew Measure National Quality Strategy Domain Measure Title and Description ¥Measure StewardPQRS ClaimsPQRS Qualified RegistryPQRS Qualified EHRCMS-SelectedGPRO(web interface)*Measures GroupsOther Quality ReportingPrograms

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 0239/ 23 Patient Safety Perioperative Care: Venous Thromboembolism (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 A MAP CPI/ N CQA X X X

0045/ 24 Care Coordinatio n Osteoporosis: Communication with thePhysician Managing Ongoing Care PostFracture of Hip, Spine or Distal Radius for Men A MAP CPI/ N CQA X XCMS-1590-P 377

Reporting MechanismNQF/PQRSNew Measure National Quality Strategy Domain Measure Title and Description ¥Measure StewardPQRS ClaimsPQRS Qualified RegistryPQRS Qualified EHRCMS-SelectedGPRO(web interface)*Measures GroupsOther Quality ReportingPrograms

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 0092/ 28 Clinical Process/ Effectivenes s 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 A MAP CPI/ N CQA 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 A MAP CPI/ N CQA X XCMS-1590-P 378

Reporting MechanismNQF/PQRSNew Measure National Quality Strategy Domain Measure Title and Description ¥Measure StewardPQRS ClaimsPQRS Qualified RegistryPQRS Qualified EHRCMS-SelectedGPRO(web interface)*Measures GroupsOther Quality ReportingPrograms

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, two hours) prior to the surgical incision (or start of procedure when no incision is required) 0240/ 31 Clinical Process/ Effectivenes s Stroke and Stroke Rehabilitation: Deep Vein Thrombosis (DVT) Prophylaxis for Ischemic Stroke or 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 two A MAP CPI/ N CQA X X

0325/ 32 Clinical Process/ Effectivenes s Stroke and Stroke Rehabilitation: Discharged on Antithrombotic Therapy: Percentage of patients aged 18 years and older with a diagnosis of ischemic stroke or A MAP CPI/ N CQA X XCMS-1590-P 379

Reporting MechanismNQF/PQRSNew Measure National Quality Strategy Domain Measure Title and Description ¥Measure StewardPQRS ClaimsPQRS Qualified RegistryPQRS Qualified EHRCMS-SelectedGPRO(web interface)*Measures GroupsOther Quality ReportingPrograms

transient ischemic attack (TIA) who were prescribed antithrombotic therapy at discharge 0241/ 33 Clinical Process/ Effectivenes s 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 A MAP CPI/ N CQA X

0243/ 35 Clinical Process/ Effectivenes s 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 A MAP CPI/ N CQA X XCMS-1590-P 380

Reporting MechanismNQF/PQRSNew Measure National Quality Strategy Domain Measure Title and Description ¥Measure StewardPQRS ClaimsPQRS Qualified RegistryPQRS Qualified EHRCMS-SelectedGPRO(web interface)*Measures GroupsOther Quality ReportingPrograms

institution in which the patient is receiving care 0244/ 36 Clinical Process/ Effectivenes s 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 A MAP CPI/ N CQA X X

0046/ 39 Clinical Process/ Effectivenes s Screening or Therapy for Osteoporosis for Women Aged 65 Years and Older: Percentage of female patients aged 65 years and older who havea central dual-energy Xray absorptiometry (DXA) measurement ordered or performed at least once since age 60 or pharmacologic therapy prescribed within 12 months A MAP CPI/ N CQA X X X X

0048/ 40 Clinical Process/ Effectivenes Osteoporosis: Management Following Fracture of Hip, Spine A MAP CPI/ N CQA X XCMS-1590-P 381

Reporting MechanismNQF/PQRSNew Measure National Quality Strategy Domain Measure Title and Description ¥Measure StewardPQRS ClaimsPQRS Qualified RegistryPQRS Qualified EHRCMS-SelectedGPRO(web interface)*Measures GroupsOther Quality ReportingPrograms

s 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 0049/ 41 Clinical Process/ Effectivenes s 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 A MAP CPI/ N CQA X X

0134/ 43 Clinical Process/ Effectivenes s 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 X X X

0236/ 44 Clinical Process/ Coronary Artery Bypass Graft (CABG): CMS/ QIP X X XCMS-1590-P 382

Reporting MechanismNQF/PQRSNew Measure National Quality Strategy Domain Measure Title and Description ¥Measure StewardPQRS ClaimsPQRS Qualified RegistryPQRS Qualified EHRCMS-SelectedGPRO(web interface)*Measures GroupsOther Quality ReportingPrograms

Effectivenes s Preoperative BetaBlocker in Patients with Isolated CABG Surgery: Percentage of patients aged 18 years and older undergoing isolated CABG surgery who received a beta-blocker within 24 hours prior to surgical incision 0637/ 45 Patient Safety Perioperative Care: Discontinuation of Prophylactic Antibiotics (Cardiac Procedures): Percentage of cardiac surgical patients aged 18 years and older undergoing procedures with the indications for prophylactic antibiotics AND who received a prophylactic antibiotic, who have an order for discontinuation of prophylactic antibiotics within 48 hours of surgical end time A MAP CPI/ N CQA X X

0097/ 46 Patient Safety Medication Reconciliation: Reconciliation After Discharge from an Inpatient Facility: Percentage of patients aged 65 years and older discharged from any inpat ient facility (e.g., hospital, A MAP CPI/ N CQA X X X ACOCMS-1590-P 383

Reporting MechanismNQF/PQRSNew Measure National Quality Strategy Domain Measure Title and Description ¥Measure StewardPQRS ClaimsPQRS Qualified RegistryPQRS Qualified EHRCMS-SelectedGPRO(web interface)*Measures GroupsOther Quality ReportingPrograms

skilled nursing facility, or rehabilitation facility) and seen within 60 days follo wing 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 medical record documented 0326/ 47 Care Coordinatio n Advanced Care Plan: Percentage of patients aged 65 years and older who have an advanced care plan or surrogate decision maker documented in the medical record or documentation in the medical record that an advanced care plan was discussed but the patient did not wish or was not able to name a surrogate decision maker or provide an advanced care plan A MAP CPI/NC QA X X X

0098/ 48 Clinical Process/ Effectivenes s 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 A MAP CPI/ N CQA X X X XCMS-1590-P 384

Reporting MechanismNQF/PQRSNew Measure National Quality Strategy Domain Measure Title and Description ¥Measure StewardPQRS ClaimsPQRS Qualified RegistryPQRS Qualified EHRCMS-SelectedGPRO(web interface)*Measures GroupsOther Quality ReportingPrograms

assessed for the presence or absence of urinary incontinence within 12 months 0099/ 49 Clinical Process/ Effectivenes s 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 A MAP CPI/ N CQA X X

0100/ 50 Patient and Family Engagement 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 A MAP CPI/ N CQA X X

0091/ 51 Clinical Process/ Effectivenes s Chronic Obstructive Pulmonary Disease (COPD): Spirometry Evaluation: Percentage of patients aged 18 years and older with a diagnosis of COPD who had A MAP CPI X X XCMS-1590-P 385

Reporting MechanismNQF/PQRSNew Measure National Quality Strategy Domain Measure Title and Description ¥Measure StewardPQRS ClaimsPQRS Qualified RegistryPQRS Qualified EHRCMS-SelectedGPRO(web interface)*Measures GroupsOther Quality ReportingPrograms

spirometry evaluation results documented 0102/ 52 Clinical Process/ Effectivenes s Chronic Obstructive Pulmonary Disease (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% and have symptoms who were prescribed an inhaled bronchodilator A MAP CPI X X X

0047/ 53 Clinical Process/ Effectivenes s 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 control medication (inhaled corticosteroid) or an acceptable alternative treatment A MAP CPI/ N CQA X X X X

0090/ 54 Clinical Process/ Effectivenes s 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 A MAP CPI/ N CQA X XCMS-1590-P 386

Reporting MechanismNQF/PQRSNew Measure National Quality Strategy Domain Measure Title and Description ¥Measure StewardPQRS ClaimsPQRS Qualified RegistryPQRS Qualified EHRCMS-SelectedGPRO(web interface)*Measures GroupsOther Quality ReportingPrograms

diagnosis of non-traumatic chest pain who had a 12- lead ECG performed 0093/ 55 Clinical Process/ Effectivenes s 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 A MAP CPI/ N CQA X X

0232/ 56 Clinical Process/ Effectivenes s Emergency Medicine: Community-Acquired 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 A MAP CPI/ N CQA X X

0096/ 59 Clinical Process/ Effectivenes s Emergency Medicine: Community-Acquired 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 A MAP CPI/ N CQA X X

0001/ Clinical Asthma: Assessment of A MA- X X X XCMS-1590-P 387

Reporting MechanismNQF/PQRSNew Measure National Quality Strategy Domain Measure Title and Description ¥Measure StewardPQRS ClaimsPQRS Qualified RegistryPQRS Qualified EHRCMS-SelectedGPRO(web interface)*Measures GroupsOther Quality ReportingPrograms

64 Process/ Effectivenes s Asthma Control: Percentage of patients aged 5 through 50 years with a diagnosis of asthma who were evaluated during at least one office visit within 12 months for the frequency (numeric) of daytime and nocturnal asthma symptoms P CPI/ N CQA

0069/ 65 Efficient Use of Healthcare Resources Treatment for Children with Upper Respiratory Infection (URI): Avoidance of Inappropriate Use: Percentage of children aged 3 months through 18 years with a diagnosis of URI who were not prescribed or dispense d

an antibiotic prescription on or within 3 days of the initial date of service N CQA X X HITE CH

0002/ 66 Efficient Use of Healthcare Resources Appropriate Testing for Children 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 N CQA X X X HITE CH

0377/ 67 Clinical Process/ Hematology: Myelodysplastic A MAP CPI/ X XCMS-1590-P 388

Reporting MechanismNQF/PQRSNew Measure National Quality Strategy Domain Measure Title and Description ¥Measure StewardPQRS ClaimsPQRS Qualified RegistryPQRS Qualified EHRCMS-SelectedGPRO(web interface)*Measures GroupsOther Quality ReportingPrograms

Effectivenes

s 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 A SH

0378/ 68 Clinical Process/ Effectivenes s 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 prior to initiating erythropoietin therapy A MAP CPI/ A SH X X

0380/ 69 Clinical Process/ Effectivenes s Hematology: Multiple Myeloma: Treatment with Bisphosphonates: Percentage of patients aged 18 years and older with a diagnosis of multiple myeloma, not in A MAP CPI/ A SH X XCMS-1590-P 389

Reporting MechanismNQF/PQRSNew Measure National Quality Strategy Domain Measure Title and Description ¥Measure StewardPQRS ClaimsPQRS Qualified RegistryPQRS Qualified EHRCMS-SelectedGPRO(web interface)*Measures GroupsOther Quality ReportingPrograms

remission, who were prescribed or received intravenous bisphosphonate therapy within the 12-month reporting period 0379/ 70 Clinical Process/ Effectivenes s Hematology: Chronic Lymphocytic Leukemia (CLL): Baseline Flow Cytometry: Percentage of patients aged 18 years and older with a diagnosis of CLL who had baseline flow cytometry studies performed A MAP CPI/ A SH X X

0387/ 71 Clinical Process/ Effectivenes s 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 who were prescribed tamoxifen or aromatase inhibitor (AI) during the 12-month reporting period A MAP CPI/ A SCO/N CCN X X X X HITE CH

0385/ 72 Clinical Process/ Effectivenes s Colon Cancer: Chemotherapy for Stage III Colon Cancer Patients: Percentage of patients aged 18 years and older with Stage IIIA A MAP CPI/ A SCO/N CCN X X X X HITE CHCMS-1590-P 390

Reporting MechanismNQF/PQRSNew Measure National Quality Strategy Domain Measure Title and Description ¥Measure StewardPQRS ClaimsPQRS Qualified RegistryPQRS Qualified EHRCMS-SelectedGPRO(web interface)*Measures GroupsOther Quality ReportingPrograms

through IIIC colon cancer who are referred for adjuvant chemotherapy, prescribed adjuvant chemotherapy, or have previously received adjuvant chemotherapy within the 12-month reporting period 0464/ 76 Patient Safety Prevention of CatheterRelated 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 A MAP CPI X X

0323/ 81 Care Coordinatio n Adult Kidney Disease: Hemodialysis Adequacy: Solute: Percentage of calendar months within a 12-month period during which patients aged 18 A MAP CPI XCMS-1590-P 391

Reporting MechanismNQF/PQRSNew Measure National Quality Strategy Domain Measure Title and Description ¥Measure StewardPQRS ClaimsPQRS Qualified RegistryPQRS Qualified EHRCMS-SelectedGPRO(web interface)*Measures GroupsOther Quality ReportingPrograms

years and older with a diagnosis of ESRD receiving hemodialysis three times a week who have a spKt/V ≥ 1.2 0321/ 82 Care Coordinatio n 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 A MAP CPI X

0393/ 83 Clinical Process/ Effectivenes s 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 A MAP CPI X

0395/ 84 Clinical Process/ Effectivenes s Hepatitis C: Ribonucleic Acid (RNA) Testing Before Initiating Treatment: Percentage of patients aged 18 years and older with a diagnosis of chronic hepatitis C who are receiving antiviral treatment for whom A MAP CPI X X XCMS-1590-P 392

Reporting MechanismNQF/PQRSNew Measure National Quality Strategy Domain Measure Title and Description ¥Measure StewardPQRS ClaimsPQRS Qualified RegistryPQRS Qualified EHRCMS-SelectedGPRO(web interface)*Measures GroupsOther Quality ReportingPrograms

quantitative HCV RNA testing was performed within 6 months prior to initiation of antiviral treatment 0396/ 85 Clinical Process/ Effectivenes s 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 A MAP CPI X X X

0397/ 86 Clinical Process/ Effectivenes s 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 A MAP CPI X X X

0398/ 87 Clinical Process/ Effectivenes s 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 A MAP CPI X X XCMS-1590-P 393

Reporting MechanismNQF/PQRSNew Measure National Quality Strategy Domain Measure Title and Description ¥Measure StewardPQRS ClaimsPQRS Qualified RegistryPQRS Qualified EHRCMS-SelectedGPRO(web interface)*Measures GroupsOther Quality ReportingPrograms

treatment for whom quantitative HCV RNA testing was performed at no greater than 12 weeks from the initiation of antiviral treatment 0401/ 89 Clinical Process/ Effectivenes s 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 A MAP CPI X X X

0394/ 90 Clinical Process/ Effectivenes s 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 A MAP CPI X X X

0653/ 91 Clinical Process/ Effectivenes s Acute Otitis Externa (AOE): Topical Therapy: Percentage of patients aged 2 years and older with a diagnosis of A MAP CPI X XCMS-1590-P 394

Reporting MechanismNQF/PQRSNew Measure National Quality Strategy Domain Measure Title and Description ¥Measure StewardPQRS ClaimsPQRS Qualified RegistryPQRS Qualified EHRCMS-SelectedGPRO(web interface)*Measures GroupsOther Quality ReportingPrograms

AOE who were prescribed topical preparations 0654/ 93 Care Coordinatio n Acute Otitis Externa (AOE): Systemic Antimicrobial Therapy – Avoidance of Inappropriate Use: Percentage of patients aged 2 years and older with a diagnosis of AOE who were not prescribed systemic antimicrobial therapy A MAP CPI X X

0391/ 99 Clinical Process/ Effectivenes s 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 A MAP CPI/ CAP X X

0392/ 100 Clinical Process/ Effectivenes s 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 A MAP CPI/ CAP X XCMS-1590-P 395

Reporting MechanismNQF/PQRSNew Measure National Quality Strategy Domain Measure Title and Description ¥Measure StewardPQRS ClaimsPQRS Qualified RegistryPQRS Qualified EHRCMS-SelectedGPRO(web interface)*Measures GroupsOther Quality ReportingPrograms

pathology reports that include the pT category (primary tumor), the pN category (regional lymph nodes) and the histologic grade 0389/ 102 Efficient Use of Healthcare Resources 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 A MAP CPI X X X HITE CH

0390/ 104 Clinical Process/ Effectivenes s 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 A MAP CPI X XCMS-1590-P 396

Reporting MechanismNQF/PQRSNew Measure National Quality Strategy Domain Measure Title and Description ¥Measure StewardPQRS ClaimsPQRS Qualified RegistryPQRS Qualified EHRCMS-SelectedGPRO(web interface)*Measures GroupsOther Quality ReportingPrograms

receiving external beam radiotherapy to the prostate who were prescribed adjuvant hormonal therapy (GnRH agonist or antagonist) 0388/ 105 Patient Safety Prostate Cancer: Three Dimensional (3D) Radiotherapy: Percentage of patients, regardless of age, with a diagnosis of clinically localized prostate cancer receiving external beam radiotherapy as a primary therapy to the prostate with or without nodal irradiation (no metastases; no salvage therapy) who receive three-dimensional conformal radiotherapy (3D-CRT) or intensity modulated radiation therapy (IMRT) A MAP CPI X X

0103/ 106 Clinical Process/ Effectivenes s Major Depressive Disorder (MDD): Diagnostic Evaluation: Percentage of patients aged 18 years and older with a new diagnosis or recurrent episode of MDD who met the DSM-IV criteria during the visit in which the new diagnosis or recurrent episode was identified during the A MAP CPI X XCMS-1590-P 397

Reporting MechanismNQF/PQRSNew Measure National Quality Strategy Domain Measure Title and Description ¥Measure StewardPQRS ClaimsPQRS Qualified RegistryPQRS Qualified EHRCMS-SelectedGPRO(web interface)*Measures GroupsOther Quality ReportingPrograms

measurement period 0104/ 107 Clinical Process/ Effectivenes s Major Depressive Disorder (MDD): Suicide Risk Assessment: Percentage of patients aged 18 years and older with a new diagnosis or recurrent episode of MDD who had a suicide risk assessment completed at each visit during the measurement period A MAP CPI X X

0054/ 108 Clinical Process/ Effectivenes s 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 N CQA X X X

0050/ 109 Patient and Family Engagement 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 A MAP CPI X X

0041/ 110 Population/ Public Health Preventive Care and Screening: Influenza Immunization: A MAP CPI X X X X X HITE CH ACOCMS-1590-P 398

Reporting MechanismNQF/PQRSNew Measure National Quality Strategy Domain Measure Title and Description ¥Measure StewardPQRS ClaimsPQRS Qualified RegistryPQRS Qualified EHRCMS-SelectedGPRO(web interface)*Measures GroupsOther Quality ReportingPrograms

Percentage of patients aged 6 months and older who received an influenza immunization during the flu season (October 1 through March 31) 0043/ 111 Clinical Process/ Effectivenes s Preventive Care and Screening: Pneumonia Vaccination for Patients 65 Years and Older: Percentage of patients aged 65 years and older who have ever received a pneumococcal vaccine N CQA X X X X X HITE CH ACO

0031/ 112 Clinical Process/ Effectivenes s Preventive Care and Screening: Screening Mammography: Percentage of women aged 40 through 69 years who had a mammogram to screen for breast cancer N CQA X X X X X HITE CH ACO

0034/ 113 Clinical Process/ Effectivenes s Preventive Care and Screening: Colorectal Cancer Screening: Percentage of patients aged 50 through 75 years who received the appropriate colorectal cancer screening N CQA X X X X X HITE CH ACO

0058/ 116 Efficient Use of Healthcare Resources Antibiotic Treatment for Adults with Acute Bronchitis: Avoidance of Inappropriate Use: Percentage of adults aged 18 through 64 years with a diagnosis of acute N CQA X XCMS-1590-P 399

Reporting MechanismNQF/PQRSNew Measure National Quality Strategy Domain Measure Title and Description ¥Measure StewardPQRS ClaimsPQRS Qualified RegistryPQRS Qualified EHRCMS-SelectedGPRO(web interface)*Measures GroupsOther Quality ReportingPrograms

bronchitis who were not prescribed or dispense d

an antibiotic prescription on or within 3 days of the initial date of service 0055/ 117 Clinical Process/ Effectivenes s 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 N CQA X X X X HITE CH

0066/ 118 Clinical Process/ Effectivenes s Coronary Artery Disease(CAD): AngiotensinConverting Enzyme (ACE) Inhibitor or Angiotensin Receptor Blocker (ARB) Therapy for Patients with CAD and Diabetes and/or Left Ventricular Systolic Dysfunction (LVSD): 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 LVEF < 40% who were prescribed ACE inhibitor or ARB therapy A MAP CPI/ A CCF/A H A X X ACO

0062/ 119 Clinical Process/ Diabetes: Urine Screening: Percentage of N CQA X X X X HITE CHCMS-1590-P 400

Reporting MechanismNQF/PQRSNew Measure National Quality Strategy Domain Measure Title and Description ¥Measure StewardPQRS ClaimsPQRS Qualified RegistryPQRS Qualified EHRCMS-SelectedGPRO(web interface)*Measures GroupsOther Quality ReportingPrograms

Effectivenes s patients aged 18 through 75 years with diabetes (type 1 or type 2) who had a nephropathy screening test or evidence of nephropathy AQA adopt ed/ 121 Clinical Process/ Effectivenes s 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 A MAP CPI X X X

AQA adopt ed/ 122 Clinical Process/ Effectivenes s 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 A MAP CPI X X X

AQA adopt ed/ Clinical Process/ Effectivenes Adult Kidney Disease: Patients OnErythropoiesisA MAP CPI X X XCMS-1590-P 401

Reporting MechanismNQF/PQRSNew Measure National Quality Strategy Domain Measure Title and Description ¥Measure StewardPQRS ClaimsPQRS Qualified RegistryPQRS Qualified EHRCMS-SelectedGPRO(web interface)*Measures GroupsOther Quality ReportingPrograms

123 s 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 0417/ 126 Clinical Process/ Effectivenes s 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 A PMA X X

0416/ 127 Clinical Process/ Diabetes Mellitus: Diabetic Foot and Ankle A PMA X XCMS-1590-P 402

Reporting MechanismNQF/PQRSNew Measure National Quality Strategy Domain Measure Title and Description ¥Measure StewardPQRS ClaimsPQRS Qualified RegistryPQRS Qualified EHRCMS-SelectedGPRO(web interface)*Measures GroupsOther Quality ReportingPrograms

Effectivenes s 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 0421/ 128 Population/ 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 six 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. 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 HITE CH 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 CMS/ QIP X X X HITE CHCMS-1590-P 403

Reporting MechanismNQF/PQRSNew Measure National Quality Strategy Domain Measure Title and Description ¥Measure StewardPQRS ClaimsPQRS Qualified RegistryPQRS Qualified EHRCMS-SelectedGPRO(web interface)*Measures GroupsOther Quality ReportingPrograms

list of current medications to the best of his/her knowledge and ability. This list must includeALL prescriptions, overthe-counters, herbals, vitamin/mineral/dietary (nutritional) supplements AND must contain the medications’ name, dosage, frequency and route 0420/ 131 Population/ Public Health Pain Assessment and Follow-Up: Percentage of patients aged 18 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 CMS/ QIP X X

0418/ 134 Population/ 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 using an age appropriate standardized tool AND follow-up plan documented CMS/ QIP X X X HITE CH ACO

0650/ Clinical Melanoma: Continuity A MA- XCMS-1590-P 404

Reporting MechanismNQF/PQRSNew Measure National Quality Strategy Domain Measure Title and Description ¥Measure StewardPQRS ClaimsPQRS Qualified RegistryPQRS Qualified EHRCMS-SelectedGPRO(web interface)*Measures GroupsOther Quality ReportingPrograms

137 Process/ Effectivenes s 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 P CPI/ N CQA

0561/ 138 Care Coordinatio n Melanoma: Coordination of Care: Percentage of patient visits, regardless of patient 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 A MAP CPI/ N CQA X

0566/ 140 Clinical Process/ Effectivenes s Age-Related Macular Degeneration (AMD): Counseling on Antioxidant A MAP CPI/ N CQA X XCMS-1590-P 405

Reporting MechanismNQF/PQRSNew Measure National Quality Strategy Domain Measure Title and Description ¥Measure StewardPQRS ClaimsPQRS Qualified RegistryPQRS Qualified EHRCMS-SelectedGPRO(web interface)*Measures GroupsOther Quality ReportingPrograms

Supplement: Percentage of patients aged 50 years and older with a diagnosis of AMD and/or their caregiver(s) who were counseled within 12 months on the benefitsand/or risks of the AgeRelated Eye Disease Study (AREDS) formulation for preventing progression of AMD 0563/ 141 Care Coordinatio n 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 and older with a diagnosis of POAG whose glaucoma treatment has not failed (the most recent IOP was reduced by atleast 15% from the preintervention level) OR if the most recent IOP was not reduced by at least15% from the preintervention level, a plan of care was documented within 12 months A MAP CPI/ N CQA X X

0051/ 142 Clinical Process/ Effectivenes s Osteoarthritis (OA): Assessment for Use of Anti-Inflammatory orAnalgesic Over-theA MAP CPI X XCMS-1590-P 406

Reporting MechanismNQF/PQRSNew Measure National Quality Strategy Domain Measure Title and Description ¥Measure StewardPQRS ClaimsPQRS Qualified RegistryPQRS Qualified EHRCMS-SelectedGPRO(web interface)*Measures GroupsOther Quality ReportingPrograms

Counter (OTC) Medications: Percentage of patient visits for patients aged 21 years and older with a diagnosis of OA with an assessmentfor use of antiinflammatory or analgesic OTC medications 0384/ 143 Patient and Family Engagement 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 A MAP CPI X X HITE CH

0383/ 144 Patient and Family Engagement Oncology: Medical and Radiation – Plan of Care for Pain: Percentage of patient visits, regardless of patient 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 A MAP CPI X X

0510/ 145 Patient Safety Radiology: Exposure Time Reported for Procedures Using Fluoroscopy: Percentage of final reports for A MAP CPI/ N CQA X XCMS-1590-P 407

Reporting MechanismNQF/PQRSNew Measure National Quality Strategy Domain Measure Title and Description ¥Measure StewardPQRS ClaimsPQRS Qualified RegistryPQRS Qualified EHRCMS-SelectedGPRO(web interface)*Measures GroupsOther Quality ReportingPrograms

procedures using fluoroscopy that include documentation of radiation exposure or exposure time 0508/ 146 Efficient Use of Healthcare Resources Radiology: Inappropriate Use of “Probably Benign” Assessment Category in Mammography Screening: Percentage of final reports for screening mammograms that are classified as “probably benign” A MAP CPI/ N CQA X X

0511/ 147 Care Coordinatio n 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 A MAP CPI X X

0322/ 148 Efficient Use of Healthcare Resources Back Pain: Initial Visit: The percentage of patients aged 18 through 79 years with a diagnosis of back pain or undergoing back N CQA XCMS-1590-P 408

Reporting MechanismNQF/PQRSNew Measure National Quality Strategy Domain Measure Title and Description ¥Measure StewardPQRS ClaimsPQRS Qualified RegistryPQRS Qualified EHRCMS-SelectedGPRO(web interface)*Measures GroupsOther Quality ReportingPrograms

surgery who had back pain and function assessed during the initial visit to the clinician for the episode of back pain 0319/ 149 Clinical Process/ Effectivenes s 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 N CQA X

0314/ 150 Clinical Process/ Effectivenes s 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 N CQA X

0313/ 151 Clinical Process/ Effectivenes s 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 four days or longer at the initial visit to the N CQA XCMS-1590-P 409

Reporting MechanismNQF/PQRSNew Measure National Quality Strategy Domain Measure Title and Description ¥Measure StewardPQRS ClaimsPQRS Qualified RegistryPQRS Qualified EHRCMS-SelectedGPRO(web interface)*Measures GroupsOther Quality ReportingPrograms

clinician for the episode of back pain AQA adopt ed/ 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 A MAP CPI/ N CQA X X

AQA adopt ed/ 155 Care Coordinatio n 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 A MAP CPI/ N CQA 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 A MAP CPI X X

0455/ 157 Patient Safety Thoracic Surgery: Recording of Clinical Stage Prior to Lung Cancer or Esophageal STS X XCMS-1590-P 410

Reporting MechanismNQF/PQRSNew Measure National Quality Strategy Domain Measure Title and Description ¥Measure StewardPQRS ClaimsPQRS Qualified RegistryPQRS Qualified EHRCMS-SelectedGPRO(web interface)*Measures GroupsOther Quality ReportingPrograms

Cancer Resection: 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/ Effectivenes s 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 A MAP CPI/ N CQA X X

0405/ 160 Clinical Process/ Effectivenes s 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 prophylaxis within 3 months of low CD4+ cell count A MAP CPI/ N CQA X X HITE CH

0406/ 161 Clinical Process/ Effectivenes s HIV/AIDS: Adolescent and Adult Patients with HIV/AIDS Who Are Prescribed Potent Antiretroviral Therapy: A MAP CPI/ N CQA X XCMS-1590-P 411

Reporting MechanismNQF/PQRSNew Measure National Quality Strategy Domain Measure Title and Description ¥Measure StewardPQRS ClaimsPQRS Qualified RegistryPQRS Qualified EHRCMS-SelectedGPRO(web interface)*Measures GroupsOther Quality ReportingPrograms

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 0407/ 162 Clinical Process/ Effectivenes s 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 A MAP CPI/ N CQA X X HITE CHCMS-1590-P 412

Reporting MechanismNQF/PQRSNew Measure National Quality Strategy Domain Measure Title and Description ¥Measure StewardPQRS ClaimsPQRS Qualified RegistryPQRS Qualified EHRCMS-SelectedGPRO(web interface)*Measures GroupsOther Quality ReportingPrograms

of care 0056/ 163 Clinical Process/ Effectivenes s Diabetes Mellitus: Foot Exam: The percentage of patients aged 18 through 75 years with diabetes who had a foot examination N CQA X X X X HITE CH

0129/ 164 Clinical Process/ Effectivenes s 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 X X

0130/ 165 Clinical Process/ Effectivenes s 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/ Effectivenes s Coronary Artery Bypass Graft (CABG): Stroke: Percentage of patients aged 18 years and older undergoing isolated CABG surgery who have STS X XCMS-1590-P 413

Reporting MechanismNQF/PQRSNew Measure National Quality Strategy Domain Measure Title and Description ¥Measure StewardPQRS ClaimsPQRS Qualified RegistryPQRS Qualified EHRCMS-SelectedGPRO(web interface)*Measures GroupsOther Quality ReportingPrograms

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 0114/ 167 Clinical Process/ Effectivenes s 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/ Effectivenes s 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/ Clinical Coronary Artery Bypass STS X XCMS-1590-P 414

Reporting MechanismNQF/PQRSNew Measure National Quality Strategy Domain Measure Title and Description ¥Measure StewardPQRS ClaimsPQRS Qualified RegistryPQRS Qualified EHRCMS-SelectedGPRO(web interface)*Measures GroupsOther Quality ReportingPrograms

169 Process/ Effectivenes s Graft (CABG): Antiplatelet Medications at Discharge: Percentage of patients aged 18 years and older undergoing isolated CABG surgery who were discharged on antiplatelet medication 0117/ 170 Clinical Process/ Effectivenes s Coronary Artery BypassGraft (CABG): BetaBlockers 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/ Effectivenes s Coronary Artery BypassGraft (CABG): AntiLipid 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 X X

0259/ 172 Clinical Process/ Effectivenes s Hemodialysis Vascular Access Decision-Making by Surgeon to Maximize Placement of Autogenous Arterial Venous (AV) Fistula: Percentage of patients aged 18 years and older SVS X XCMS-1590-P 415

Reporting MechanismNQF/PQRSNew Measure National Quality Strategy Domain Measure Title and Description ¥Measure StewardPQRS ClaimsPQRS Qualified RegistryPQRS Qualified EHRCMS-SelectedGPRO(web interface)*Measures GroupsOther Quality ReportingPrograms

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 AQA adopt ed/ 173 Population/ 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 A MAP CPI X X X X

AQA adopt ed/ 176 Clinical Process/ Effectivenes s 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 using a biologicdisease-modifying antirheumatic drug (DMARD) A MAP CPI/ N CQA X X X

AQA adopt Clinical Process/ Rheumatoid Arthritis (RA): Periodic A MAP CPI/ X X XCMS-1590-P 416

Reporting MechanismNQF/PQRSNew Measure National Quality Strategy Domain Measure Title and Description ¥Measure StewardPQRS ClaimsPQRS Qualified RegistryPQRS Qualified EHRCMS-SelectedGPRO(web interface)*Measures GroupsOther Quality ReportingPrograms

ed/ 177 Effectivenes s 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 N CQA

AQA adopt ed/ 178 Clinical Process/ Effectivenes s 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 A MAP CPI/ N CQA X X X

AQA adopt ed/ 179 Clinical Process/ Effectivenes s 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 A MAP CPI/ N CQA X X X

AQA adopt ed/ 180 Care Coordinatio n Rheumatoid Arthritis (RA): Glucocorticoid Management: Percentage of patients aged 18 years and older with a diagnosis of RA who have been assessed for A MAP CPI/ N CQA X X XCMS-1590-P 417

Reporting MechanismNQF/PQRSNew Measure National Quality Strategy Domain Measure Title and Description ¥Measure StewardPQRS ClaimsPQRS Qualified RegistryPQRS Qualified EHRCMS-SelectedGPRO(web interface)*Measures GroupsOther Quality ReportingPrograms

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 AQA adopt ed/ 181 Patient Safety Elder Maltreatment Screen and Follow-Up Plan: Percentage of patients aged 65 years and older with documentation of a screen for elder maltreatment AND documented follow-up plan CMS/ QIP X X

AQA adopt ed/ 182 Care Coordinatio n Functional Outcome Assessment: Percentage of patients aged 18 years and older with documentation of a current functional outcome assessment using a standardized functional outcome assessment tool AND documentation of a care plan based on identified functional outcome deficiencies CMS/ QIP X X

0399/ 183 Population/ Public Health Hepatitis C: Hepatitis A Vaccination in Patients with HCV: Percentage of patients aged 18 years and A MAP CPI X X XCMS-1590-P 418

Reporting MechanismNQF/PQRSNew Measure National Quality Strategy Domain Measure Title and Description ¥Measure StewardPQRS ClaimsPQRS Qualified RegistryPQRS Qualified EHRCMS-SelectedGPRO(web interface)*Measures GroupsOther Quality ReportingPrograms

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 0400/ 184 Population/ 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 A MAP CPI X X X

0659/ 185 Care Coordinatio n 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 colonic polyp(s) in a previous colonoscopy, who had a follow-up interval of 3 or more years since their last colonoscopy documented in the colonoscopy report A MAP CPI/ N CQA X X

0437/ 187 Clinical Process/ Stroke and Stroke Rehabilitation: A HA/ A SA/ TJC XCMS-1590-P 419

Reporting MechanismNQF/PQRSNew Measure National Quality Strategy Domain Measure Title and Description ¥Measure StewardPQRS ClaimsPQRS Qualified RegistryPQRS Qualified EHRCMS-SelectedGPRO(web interface)*Measures GroupsOther Quality ReportingPrograms

Effectivenes s Thrombolytic Therapy: Percentage of patients aged 18 years and older with a diagnosis of acute ischemic stroke who arrive at the hospital within two hours of time last known well and for whom IV t-PA was initiated within three hours of time last known well N/A/ 188 Care Coordinatio n 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) A QC X X

0565/ 191 Clinical Process/ Effectivenes s 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 A MAP CPI/ N CQA X X HITE CHCMS-1590-P 420

Reporting MechanismNQF/PQRSNew Measure National Quality Strategy Domain Measure Title and Description ¥Measure StewardPQRS ClaimsPQRS Qualified RegistryPQRS Qualified EHRCMS-SelectedGPRO(web interface)*Measures GroupsOther Quality ReportingPrograms

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 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 A MAP CPI/ N CQA X X HITE CH

0454/ 193 Patient Safety Perioperative Temperature A MAP CPI X XCMS-1590-P 421

Reporting MechanismNQF/PQRSNew Measure National Quality Strategy Domain Measure Title and Description ¥Measure StewardPQRS ClaimsPQRS Qualified RegistryPQRS Qualified EHRCMS-SelectedGPRO(web interface)*Measures GroupsOther Quality ReportingPrograms

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 0386/ 194 Clinical Process/ Effectivenes s 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 metastatic in the medical record at least once within 12 months A MAP CPI/ A SCO X X XCMS-1590-P 422

Reporting MechanismNQF/PQRSNew Measure National Quality Strategy Domain Measure Title and Description ¥Measure StewardPQRS ClaimsPQRS Qualified RegistryPQRS Qualified EHRCMS-SelectedGPRO(web interface)*Measures GroupsOther Quality ReportingPrograms

0507/ 195 Clinical Process/ Effectivenes s Radiology: Stenosis Measurement in Carotid Imaging Reports: Percentage of final reports for all patients, regardless of age, 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 A MAP CPI/ N CQA X X

0074/ 197 Clinical Process/ Effectivenes s 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 ORpatients who have a LDLC 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 A MAP CPI/ A CCF/A H A X X X X ACO

0079/ Clinical Heart Failure: Left A MA- X XCMS-1590-P 423

Reporting MechanismNQF/PQRSNew Measure National Quality Strategy Domain Measure Title and Description ¥Measure StewardPQRS ClaimsPQRS Qualified RegistryPQRS Qualified EHRCMS-SelectedGPRO(web interface)*Measures GroupsOther Quality ReportingPrograms

198 Process/ Effectivenes s 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 P CPI/ A CCF/A H A

0084/ 200 Clinical Process/ Effectivenes s 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 A MAP CPI/ A CCF/A H A X

0073/ 201 Clinical Process/ Effectivenes s 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) N CQA X X X X HITE CH

0068/ 204 Clinical Process/ Effectivenes Ischemic Vascular Disease (IVD): Use of Aspirin or Another N CQA X X X X X HITE CH ACOCMS-1590-P 424

Reporting MechanismNQF/PQRSNew Measure National Quality Strategy Domain Measure Title and Description ¥Measure StewardPQRS ClaimsPQRS Qualified RegistryPQRS Qualified EHRCMS-SelectedGPRO(web interface)*Measures GroupsOther Quality ReportingPrograms

s Antithrombotic: Percentage of patients aged 18 years and older with ischemic vascular disease (IVD) with documented use of aspirin or other antithrombotic Millio n Hearts

0409/ 205 Clinical Process/ Effectivenes s 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 A MAP CPI/ N CQA X X

0413/ 206 Clinical Process/ Effectivenes s 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 A MAP CPI/ N CQA X X

0415/ 207 Clinical Process/ Effectivenes s HIV/AIDS: Screening for Injection Drug Use: Percentage of patients aged 13 years and older with a diagnosis of HIV/AIDS who were screened for injection A MAP CPI/ N CQA X XCMS-1590-P 425

Reporting MechanismNQF/PQRSNew Measure National Quality Strategy Domain Measure Title and Description ¥Measure StewardPQRS ClaimsPQRS Qualified RegistryPQRS Qualified EHRCMS-SelectedGPRO(web interface)*Measures GroupsOther Quality ReportingPrograms

drug use at least once within 12 months 0410/ 208 Clinical Process/ Effectivenes s 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 A MAP CPI/ N CQA X X

0445/ 209 Care Coordinatio n Functional Communication Measure - 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 SHA X

0449/ 210 Care Coordinatio n 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 A SHA XCMS-1590-P 426

Reporting MechanismNQF/PQRSNew Measure National Quality Strategy Domain Measure Title and Description ¥Measure StewardPQRS ClaimsPQRS Qualified RegistryPQRS Qualified EHRCMS-SelectedGPRO(web interface)*Measures GroupsOther Quality ReportingPrograms

Communication Measure 0448/ 211 Care Coordinatio n 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 A SHA X

0446/ 213 Care Coordinatio n 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 A SHA X

0444/ 214 Care Coordinatio n 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 A SHA XCMS-1590-P 427

Reporting MechanismNQF/PQRSNew Measure National Quality Strategy Domain Measure Title and Description ¥Measure StewardPQRS ClaimsPQRS Qualified RegistryPQRS Qualified EHRCMS-SelectedGPRO(web interface)*Measures GroupsOther Quality ReportingPrograms

0442/ 215 Care Coordinatio n 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 A SHA X

0443/ 216 Care Coordinatio n Functional Communication Measure – Swallowing: Percentage of patients aged 16 years and older with a diagnosis of late effects of cerebrovascular disease (CVD) that make progress on the Swallowing Functional Communication Measure A SHA X

0422/ 217 Care Coordinatio n 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 F OTO XCMS-1590-P 428

Reporting MechanismNQF/PQRSNew Measure National Quality Strategy Domain Measure Title and Description ¥Measure StewardPQRS ClaimsPQRS Qualified RegistryPQRS Qualified EHRCMS-SelectedGPRO(web interface)*Measures GroupsOther Quality ReportingPrograms

0423/ 218 Care Coordinatio n 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 F OTO X

0424/ 219 Care Coordinatio n 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 thechange in their RiskAdjusted Functional Status is measured F OTO X

0425/ 220 Care Coordinatio n Functional Deficit:Change in RiskAdjusted Functional Status for Patients with Lumbar Spine Impairments: Percentage F OTO XCMS-1590-P 429

Reporting MechanismNQF/PQRSNew Measure National Quality Strategy Domain Measure Title and Description ¥Measure StewardPQRS ClaimsPQRS Qualified RegistryPQRS Qualified EHRCMS-SelectedGPRO(web interface)*Measures GroupsOther Quality ReportingPrograms

of patients aged 18 or older that receive treatment for a functional deficit secondary to a diagnosis that affects the lumbar spine in which thechange in their RiskAdjusted Functional Status is measured 0426/ 221 Care Coordinatio n 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 F OTO X

0427/ 222 Care Coordinatio n Functional Deficit:Change in RiskAdjusted 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 or hand in which the change in their F OTO XCMS-1590-P 430

Reporting MechanismNQF/PQRSNew Measure National Quality Strategy Domain Measure Title and Description ¥Measure StewardPQRS ClaimsPQRS Qualified RegistryPQRS Qualified EHRCMS-SelectedGPRO(web interface)*Measures GroupsOther Quality ReportingPrograms

Risk-Adjusted Functional Status is measured 0428/ 223 Care Coordinatio n 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 thechange in their RiskAdjusted Functional Status is measured F OTO X

0562/ 224 Efficient Use of Healthcare Resources Melanoma: Overutilization of Imaging Studies in Melanoma: Percentage of patients, regardless of age, with a current diagnosis of melanoma or a history of melanoma, without signs or symptoms, seen for anoffice visit during the oneyear measurement period, for whom no diagnostic A MAP CPI/ N CQA XCMS-1590-P 431

Reporting MechanismNQF/PQRSNew Measure National Quality Strategy Domain Measure Title and Description ¥Measure StewardPQRS ClaimsPQRS Qualified RegistryPQRS Qualified EHRCMS-SelectedGPRO(web interface)*Measures GroupsOther Quality ReportingPrograms

imaging studies were ordered 0509/ 225 Care Coordinatio n 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 A MAP CPI/ N CQA X X

0028/ 226 Population/ Public Health Preventive Care and Screening: Tobacco 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 counseling intervention if identified as a tobacco user A MAP CPI X X X X X HITE CH ACO Millio n Hearts

N/A/ 228 Clinical Process/ Effectivenes s Heart Failure (HF): Left Ventricular Function (LVF) Testing: Percentage of patients 18 years and older with LVF testing performed during the measurement period for patients hospitalized with a principal diagnosis of HF during the reporting CMS/ QIP XCMS-1590-P 432

Reporting MechanismNQF/PQRSNew Measure National Quality Strategy Domain Measure Title and Description ¥Measure StewardPQRS ClaimsPQRS Qualified RegistryPQRS Qualified EHRCMS-SelectedGPRO(web interface)*Measures GroupsOther Quality ReportingPrograms

period N/A/ 231 Clinical Process/ Effectivenes s 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 A MAP CPI/ N CQA X X X

N/A/ 232 Clinical Process/ Effectivenes s 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 atleast once during the oneyear measurement period A MAP CPI/ N CQA X X X

0457/ 233 Clinical Process/ Thoracic Surgery: Recording of STS XCMS-1590-P 433

Reporting MechanismNQF/PQRSNew Measure National Quality Strategy Domain Measure Title and Description ¥Measure StewardPQRS ClaimsPQRS Qualified RegistryPQRS Qualified EHRCMS-SelectedGPRO(web interface)*Measures GroupsOther Quality ReportingPrograms

Effectivenes s 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 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/ Effectivenes s Hypertension (HTN): Controlling High Blood Pressure: Percentage of patients aged 18 through 85 years of age who had a diagnosis of hypertension N CQA X X X X X HITE CH ACO Millio n HeartsCMS-1590-P 434

Reporting MechanismNQF/PQRSNew Measure National Quality Strategy Domain Measure Title and Description ¥Measure StewardPQRS ClaimsPQRS Qualified RegistryPQRS Qualified EHRCMS-SelectedGPRO(web interface)*Measures GroupsOther Quality ReportingPrograms

(HTN) and whose BP was adequately controlled (< 140/90 mmHg) 0013/ 237 Clinical Process/ Effectivenes s Hypertension (HTN): Blood Pressure Measurement: Percentage of patient visits for patients aged 18 years and older with a diagnosis of HTN with blood pressure (BP) recorded A MAP CPI X

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 N CQA X HITE CH

0024/ 239 Population/ 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 N CQA X HITE CHCMS-1590-P 435

Reporting MechanismNQF/PQRSNew Measure National Quality Strategy Domain Measure Title and Description ¥Measure StewardPQRS ClaimsPQRS Qualified RegistryPQRS Qualified EHRCMS-SelectedGPRO(web interface)*Measures GroupsOther Quality ReportingPrograms

0038/ 240 Population/ Public Health Childhood Immunization Status: The percentage of children two 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 N CQA X HITE CH

0075/ 241 Clinical Process/ Effectivenes s 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) N CQA X X X X X HITE CH ACO Millio n Hearts

N/A/ 242 Clinical Process/ Coronary Artery Disease (CAD): Symptom A MAP CPI/ X XCMS-1590-P 436

Reporting MechanismNQF/PQRSNew Measure National Quality Strategy Domain Measure Title and Description ¥Measure StewardPQRS ClaimsPQRS Qualified RegistryPQRS Qualified EHRCMS-SelectedGPRO(web interface)*Measures GroupsOther Quality ReportingPrograms

Effectivenes s 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 A CCF/A H A

0643/ 243 Clinical Process/ Effectivenes s Cardiac Rehabilitation Patient Referral from an Outpatient Setting: Percentage of patients evaluated in an outpatient setting who within the past 12 months have experienced an 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 A CCFA HA XCMS-1590-P 437

Reporting MechanismNQF/PQRSNew Measure National Quality Strategy Domain Measure Title and Description ¥Measure StewardPQRS ClaimsPQRS Qualified RegistryPQRS Qualified EHRCMS-SelectedGPRO(web interface)*Measures GroupsOther Quality ReportingPrograms

for the qualifying event/diagnosis who were referred to a CR program N/A/ 244 Clinical Process/ Effectivenes s 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 A MAP CPI/ A CCF/A H A X

AQA adopt ed/ 245 Clinical Process/ Effectivenes s Chronic Wound Care: Use of Wound Surface Culture Technique in Patients with Chronic Skin Ulcers: 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 A MAP CPI/ N CQA X X

AQA adopt ed/ 246 Clinical Process/ Effectivenes s Chronic Wound Care: Use of Wet to Dry Dressings in Patients with Chronic Skin Ulcers: Percentage of patient visits for those patients aged 18 years and older with a diagnosis of A MAP CPI/ N CQA X XCMS-1590-P 438

Reporting MechanismNQF/PQRSNew Measure National Quality Strategy Domain Measure Title and Description ¥Measure StewardPQRS ClaimsPQRS Qualified RegistryPQRS Qualified EHRCMS-SelectedGPRO(web interface)*Measures GroupsOther Quality ReportingPrograms

chronic skin ulcer without a prescription or recommendation to use wet to dry dressings AQA adopt ed/ 247 Clinical Process/ Effectivenes s 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 A MAP CPI/ N CQA X X

AQA adopt ed/ 248 Clinical Process/ Effectivenes s Substance Use Disorders: Screening for Depression Among Patients with 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 A MAP CPI/ N CQA X X

N/A/ 249 Clinical Process/ Effectivenes Barrett's Esophagus: Percentage of esophageal biopsy reports that CAP X XCMS-1590-P 439

Reporting MechanismNQF/PQRSNew Measure National Quality Strategy Domain Measure Title and Description ¥Measure StewardPQRS ClaimsPQRS Qualified RegistryPQRS Qualified EHRCMS-SelectedGPRO(web interface)*Measures GroupsOther Quality ReportingPrograms

s document the presence of Barrett’s mucosa that also include a statement about dysplasia N/A/ 250 Clinical Process/ Effectivenes s 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/ Effectivenes s 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/ Effectivenes s Anticoagulation for Acute Pulmonary Embolus Patients: Anticoagulation ordered A CEP X XCMS-1590-P 440

Reporting MechanismNQF/PQRSNew Measure National Quality Strategy Domain Measure Title and Description ¥Measure StewardPQRS ClaimsPQRS Qualified RegistryPQRS Qualified EHRCMS-SelectedGPRO(web interface)*Measures GroupsOther Quality ReportingPrograms

for patients who have been discharged from the emergency department (ED) with a diagnosis of acute pulmonary embolus 0651/ 254 Clinical Process/ Effectivenes s 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 transabdominal or transvaginal ultrasound to determine pregnancy location A CEP X X

0652/ 255 Clinical Process/ Effectivenes s Rh Immunoglobulin(Rhogam) for RhNegative Pregnant Women at Risk of Fetal Blood Exposure: Percentage of Rh-negative pregnant women aged 14- 50 years at risk of fetal blood exposure whoreceive RhImmunoglobulin (Rhogam) in the emergency department (ED) A CEP X XCMS-1590-P 441

Reporting MechanismNQF/PQRSNew Measure National Quality Strategy Domain Measure Title and Description ¥Measure StewardPQRS ClaimsPQRS Qualified RegistryPQRS Qualified EHRCMS-SelectedGPRO(web interface)*Measures GroupsOther Quality ReportingPrograms

N/A/ 256 Care Coordinatio n 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/ Effectivenes s Statin Therapy at Discharge after Lower Extremity Bypass (LEB): Percentage of patients aged 18 years andolder undergoing infrainguinal lower extremity bypass who are prescribed a statin medication at discharge SVS X

N/A/ 258 Care Coordinatio n Rate of Open Elective Repair of Small or Moderate Abdominal Aortic Aneurysms (AAA) without Major Complications (Discharged to Home by Post-Operative Day #7): Percent of patients SVS XCMS-1590-P 442

Reporting MechanismNQF/PQRSNew Measure National Quality Strategy Domain Measure Title and Description ¥Measure StewardPQRS ClaimsPQRS Qualified RegistryPQRS Qualified EHRCMS-SelectedGPRO(web interface)*Measures GroupsOther Quality ReportingPrograms

undergoing open repair of small or moderate sized abdominal aortic aneurysms who do not experience a major complication (discharge tohome no later than postoperative day #7) N/A/ 259 Care Coordinatio n Rate of Elective Endovascular Aortic Repair (EVAR) of Small or Moderate 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 abdominal aortic aneurysms (AAA) that do not experience a major complication (discharged to home no later than post-operative day #2) SVS X

N/A/ 260 Care Coordinatio n Rate of Carotid Endarterectomy (CEA) for Asymptomatic Patients, without Major Complications (Discharged to Home Post-Operative Day #2): Percent of asymptomatic patients undergoing CEA who are discharged to SVS XCMS-1590-P 443

Reporting MechanismNQF/PQRSNew Measure National Quality Strategy Domain Measure Title and Description ¥Measure StewardPQRS ClaimsPQRS Qualified RegistryPQRS Qualified EHRCMS-SelectedGPRO(web interface)*Measures GroupsOther Quality ReportingPrograms

home no later than postoperative day #2 N/A/ 261 Care Coordinatio n Referral for Otologic Evaluation for Patients with Acute or Chronic Dizziness: Percentage of patients aged 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 A QC X X

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 patientswith nonpalpable, imagedetected 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 A SBS X XCMS-1590-P 444

Reporting MechanismNQF/PQRSNew Measure National Quality Strategy Domain Measure Title and Description ¥Measure StewardPQRS ClaimsPQRS Qualified RegistryPQRS Qualified EHRCMS-SelectedGPRO(web interface)*Measures GroupsOther Quality ReportingPrograms

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. N/A/ 263 Clinical Process/ Effectivenes s 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 (excludes open/incisional biopsies) A SBS X X

N/A/ 264 Clinical Process/ Effectivenes s 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 A SBS X

0645/ 265 Care Coordinatio n Biopsy Follow-Up: Percentage of patients whose biopsy results have been reviewed and communicated to the primary care/referring physician and patient by A AD XCMS-1590-P 445

Reporting MechanismNQF/PQRSNew Measure National Quality Strategy Domain Measure Title and Description ¥Measure StewardPQRS ClaimsPQRS Qualified RegistryPQRS Qualified EHRCMS-SelectedGPRO(web interface)*Measures GroupsOther Quality ReportingPrograms

the performing physician N/A/ 266 Clinical Process/ Effectivenes s 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 A AN X X

N/A/ 267 Clinical Process/ Effectivenes s Epilepsy: Documentation of Etiology of Epilepsy or Epilepsy Syndrome: All visits for patients with a diagnosis of epilepsy who had their etiology of epilepsy or with epilepsy syndrome(s) reviewed and documented if known, or documented as unknown or cryptogenic A AN X X

N/A/ 268 Clinical Process/ Effectivenes s 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 A AN X XCMS-1590-P 446

Reporting MechanismNQF/PQRSNew Measure National Quality Strategy Domain Measure Title and Description ¥Measure StewardPQRS ClaimsPQRS Qualified RegistryPQRS Qualified EHRCMS-SelectedGPRO(web interface)*Measures GroupsOther Quality ReportingPrograms

N/A/ 269 Clinical Process/ Effectivenes s 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 A GA X

N/A/ 270 Clinical Process/ Effectivenes s 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 corticosteroid sparing therapy in the last reporting year A GA X

N/A/ 271 Clinical Process/ Effectivenes s Inflammatory Bowel Disease (IBD): Preventive Care: Corticosteroid Related A GA XCMS-1590-P 447

Reporting MechanismNQF/PQRSNew Measure National Quality Strategy Domain Measure Title and Description ¥Measure StewardPQRS ClaimsPQRS Qualified RegistryPQRS Qualified EHRCMS-SelectedGPRO(web interface)*Measures GroupsOther Quality ReportingPrograms

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 N/A/ 272 Clinical Process/ Effectivenes s 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 A GA X

N/A/ 273 Clinical Process/ Effectivenes s Inflammatory Bowel Disease (IBD): Preventive Care: Pneumococcal Immunization: Percentage of patients aged 18 years and older with a diagnosis of A GA XCMS-1590-P 448

Reporting MechanismNQF/PQRSNew Measure National Quality Strategy Domain Measure Title and Description ¥Measure StewardPQRS ClaimsPQRS Qualified RegistryPQRS Qualified EHRCMS-SelectedGPRO(web interface)*Measures GroupsOther Quality ReportingPrograms

inflammatory bowel disease that had pneumococcal vaccination administered or previously received N/A/ 274 Clinical Process/ Effectivenes s 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 A GA X

N/A/ 275 Clinical Process/ Effectivenes s Inflammatory Bowel Disease (IBD): Assessment of Hepatitis B Virus (HBV) StatusBefore 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 A GA XCMS-1590-P 449

Reporting MechanismNQF/PQRSNew Measure National Quality Strategy Domain Measure Title and Description ¥Measure StewardPQRS ClaimsPQRS Qualified RegistryPQRS Qualified EHRCMS-SelectedGPRO(web interface)*Measures GroupsOther Quality ReportingPrograms

assessed and results interpreted within one year prior to receiving a first course of anti-TNF (tumor necrosis factor) therapy N/A/ 276 Clinical Process/ Effectivenes s 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 A MAP CPI/ N CQA X

N/A/ 277 Clinical Process/ Effectivenes s 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 A MAP CPI/ N CQA X

N/A/ 278 Clinical Process/ Effectivenes s Sleep Apnea: Positive Airway Pressure Therapy Prescribed: Percentage of patients aged 18 years and older with a diagnosis of A MAP CPI/ N CQA XCMS-1590-P 450

Reporting MechanismNQF/PQRSNew Measure National Quality Strategy Domain Measure Title and Description ¥Measure StewardPQRS ClaimsPQRS Qualified RegistryPQRS Qualified EHRCMS-SelectedGPRO(web interface)*Measures GroupsOther Quality ReportingPrograms

moderate or severe obstructive sleep apnea who were prescribed positive airway pressure therapy N/A/ 279 Clinical Process/ Effectivenes s 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 sleep apnea who were prescribed positive airway pressure therapy who had documentation that adherence to positive airway pressure therapy was objectively measured A MAP CPI/ N CQA X

N/A/ 280 Care Coordinatio n 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 A MAP CPI X

N/A/ 281 Clinical Process/ Effectivenes s 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 A MAP CPI X HITE CHCMS-1590-P 451

Reporting MechanismNQF/PQRSNew Measure National Quality Strategy Domain Measure Title and Description ¥Measure StewardPQRS ClaimsPQRS Qualified RegistryPQRS Qualified EHRCMS-SelectedGPRO(web interface)*Measures GroupsOther Quality ReportingPrograms

reviewed at least once within a 12 month period N/A/ 282 Clinical Process/ Effectivenes s 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 A MAP CPI X

N/A/ 283 Clinical Process/ Effectivenes s 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 A MAP CPI X

N/A/ 284 Clinical Process/ Effectivenes s 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 A MAP CPI XCMS-1590-P 452

Reporting MechanismNQF/PQRSNew Measure National Quality Strategy Domain Measure Title and Description ¥Measure StewardPQRS ClaimsPQRS Qualified RegistryPQRS Qualified EHRCMS-SelectedGPRO(web interface)*Measures GroupsOther Quality ReportingPrograms

neuropsychiatric symptoms within a 12 month period N/A/ 285 Clinical Process/ Effectivenes s 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 A MAP CPI X

N/A/ 286 Patient Safety Dementia: Counseling Regarding Safety Concerns: Percentage of patients, regardless of age, with a diagnosis of dementia or their caregiver(s) who were counseled or referred for counseling regarding safety concerns within a 12 month period A MAP CPI X

N/A/ 287 Clinical Process/ Effectivenes s 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 driving alternatives within a 12 month period A MAP CPI X

N/A/ 288 Clinical Process/ Effectivenes Dementia: Caregiver Education and Support: Percentage of patients, A MAP CPI XCMS-1590-P 453

Reporting MechanismNQF/PQRSNew Measure National Quality Strategy Domain Measure Title and Description ¥Measure StewardPQRS ClaimsPQRS Qualified RegistryPQRS Qualified EHRCMS-SelectedGPRO(web interface)*Measures GroupsOther Quality ReportingPrograms

s 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 N/A/ 289 Clinical Process/ Effectivenes s 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 A AN X

N/A/ 290 Clinical Process/ Effectivenes Parkinson’s Disease: Psychiatric Disorders or Disturbances A AN XCMS-1590-P 454

Reporting MechanismNQF/PQRSNew Measure National Quality Strategy Domain Measure Title and Description ¥Measure StewardPQRS ClaimsPQRS Qualified RegistryPQRS Qualified EHRCMS-SelectedGPRO(web interface)*Measures GroupsOther Quality ReportingPrograms

s 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 N/A/ 291 Clinical Process/ Effectivenes s 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 A AN X

N/A/ 292 Clinical Process/ Effectivenes s 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 A AN X

N/A/ 293 Clinical Process/ Effectivenes s 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, A AN XCMS-1590-P 455

Reporting MechanismNQF/PQRSNew Measure National Quality Strategy Domain Measure Title and Description ¥Measure StewardPQRS ClaimsPQRS Qualified RegistryPQRS Qualified EHRCMS-SelectedGPRO(web interface)*Measures GroupsOther Quality ReportingPrograms

occupational, or speech therapy) discussed at least annually N/A/ 294 Clinical Process/ Effectivenes s 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 disease treatment options (e.g., non-pharmacological treatment, pharmacological treatment, or surgical treatment) reviewed at least once annually A AN X

N/A/ 295 Clinical Process/ Effectivenes s Hypertension: Appropriate Use of Aspirin or Other Antiplatelet 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 A BIM X

N/A/ 296 Clinical Process/ Effectivenes s Hypertension: Complete Lipid Profile: Percentage of patients aged 15 through 90 years old with A BIM XCMS-1590-P 456

Reporting MechanismNQF/PQRSNew Measure National Quality Strategy Domain Measure Title and Description ¥Measure StewardPQRS ClaimsPQRS Qualified RegistryPQRS Qualified EHRCMS-SelectedGPRO(web interface)*Measures GroupsOther Quality ReportingPrograms

a diagnosis of hypertension who received a complete lipid profile within 24 months N/A/ 297 Clinical Process/ Effectivenes s 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 A BIM X

N/A/ 298 Clinical Process/ Effectivenes s 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 A BIM X

N/A/ 299 Clinical Process/ Effectivenes s 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 A BIM X

N/A/ 300 Clinical Process/ Effectivenes s Hypertension: Blood Pressure Control: Percentage of patients aged 15 through 90 years old with a diagnosis of A BIM XCMS-1590-P 457

Reporting MechanismNQF/PQRSNew Measure National Quality Strategy Domain Measure Title and Description ¥Measure StewardPQRS ClaimsPQRS Qualified RegistryPQRS Qualified EHRCMS-SelectedGPRO(web interface)*Measures GroupsOther Quality ReportingPrograms

hypertension who had most recent blood pressure level under control (at goal) N/A/ 301 Clinical Process/ Effectivenes s Hypertension: Low Density Lipoprotein (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) A BIM X

N/A/ 302 Clinical Process/ Effectivenes s 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 A BIM X

N/A/ 303 Clinical Process/ Effectivenes s 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 achie ved within A AO X XCMS-1590-P 458

Reporting MechanismNQF/PQRSNew Measure National Quality Strategy Domain Measure Title and Description ¥Measure StewardPQRS ClaimsPQRS Qualified RegistryPQRS Qualified EHRCMS-SelectedGPRO(web interface)*Measures GroupsOther Quality ReportingPrograms

90 days following the cataract surgery, based oncompleting a preoperative and postoperative visual function survey N/A/ 304 Patient and Family Engagement 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 A AO X X

0004/ 305 Clinical Process/ Effectivenes s 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 N CQA X HITE CHCMS-1590-P 459

Reporting MechanismNQF/PQRSNew Measure National Quality Strategy Domain Measure Title and Description ¥Measure StewardPQRS ClaimsPQRS Qualified RegistryPQRS Qualified EHRCMS-SelectedGPRO(web interface)*Measures GroupsOther Quality ReportingPrograms

hospitalization within 14 days of the diagnosis and who initiated treatment AND who had two or more additional services with an AOD diagnosis within 30 days of the initial visit 0012/ 306 Population/ 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 A MAP CPI X

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 A MAP CPI X

0027/ 308 Population/ 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. N CQA XCMS-1590-P 460

Reporting MechanismNQF/PQRSNew Measure National Quality Strategy Domain Measure Title and Description ¥Measure StewardPQRS ClaimsPQRS Qualified RegistryPQRS Qualified EHRCMS-SelectedGPRO(web interface)*Measures GroupsOther Quality ReportingPrograms

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 0032/ 309 Clinical Process/ Effectivenes s Cervical Cancer Screening: Percentage of women aged 21 through 63 years who received one or more Pap tests to screen for cervical cancer N CQA X HITE CH

0033/ 310 Population/ 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 N CQA X HITE CH

0036/ 311 Clinical Process/ Effectivenes s Use of Appropriate Medications for Asthma: Percentage of patients aged 5 through 50 years of N CQA X HITE CHCMS-1590-P 461

Reporting MechanismNQF/PQRSNew Measure National Quality Strategy Domain Measure Title and Description ¥Measure StewardPQRS ClaimsPQRS Qualified RegistryPQRS Qualified EHRCMS-SelectedGPRO(web interface)*Measures GroupsOther Quality ReportingPrograms

age who were identified as having persistent asthma and were appropriately prescribed medication during the measurement year 0052/ 312 Efficient Use of Healthcare Resources Low Back Pain: Use of Imaging Studies: Percentage of patients with a primary diagnosis of low back pain who did not have an imaging study (plain X-ray, MRI, CT scan) within 28 days of diagnosis N CQA X HITE CH

0575/ 313 Clinical Process/ Effectivenes s 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% N CQA X

N/A/ 316 Clinical Process/ Effectivenes s Preventive Care and Screening: Cholesterol – Fasting Low Density Lipoprotein (LDL) TestPerformed AND RiskStratified 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 CMS/ QIP X HITE CH Millio n HeartsCMS-1590-P 462

Reporting MechanismNQF/PQRSNew Measure National Quality Strategy Domain Measure Title and Description ¥Measure StewardPQRS ClaimsPQRS Qualified RegistryPQRS Qualified EHRCMS-SelectedGPRO(web interface)*Measures GroupsOther Quality ReportingPrograms

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 N/A/ 317 Population/ Public Health Preventive Care and Screening: Screening for High Blood Pressure: Percentage of patients aged 18 and older who are screened for high blood pressure CMS/ QIP X X X X X HITE CH ACO Millio n 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 12 months A MAP CPI/ N CQA X HITE CH ACO

TBD/ TBD X Clinical Process/ Effectivenes s Stroke and Stroke Rehabilitation: Tissue Plasminogen Activator (t-PA) Considered (Paired Measure): Percentage of patients aged 18 years and older with a diagnosis of ischemic stroke who arrive at the hospital within 4.5 hours of time A MAP CPI X XCMS-1590-P 463

Reporting MechanismNQF/PQRSNew Measure National Quality Strategy Domain Measure Title and Description ¥Measure StewardPQRS ClaimsPQRS Qualified RegistryPQRS Qualified EHRCMS-SelectedGPRO(web interface)*Measures GroupsOther Quality ReportingPrograms

last known well who were considered for t-PA administration TBD/ TBD X Clinical Process/ Effectivenes s Stroke and Stroke Rehabilitation: Tissue Plasminogen Activator (t-PA) Administered Initiated (Paired Measure): Percentage of all patients aged 18 years and older with a diagnosis of ischemic stroke who present within two hours of time last known welland who are eligible for tPA, for whom t-PA was initiated within three hours of time last known well A MAP CPI X X

0729/ TBD X Clinical Process/ Effectivenes s 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 M NCM X ACO

0658/ TBD X Care Coordinatio Endoscopy and Polyp Surveillance: A MAP CPI X XCMS-1590-P 464

Reporting MechanismNQF/PQRSNew Measure National Quality Strategy Domain Measure Title and Description ¥Measure StewardPQRS ClaimsPQRS Qualified RegistryPQRS Qualified EHRCMS-SelectedGPRO(web interface)*Measures GroupsOther Quality ReportingPrograms

n Appropriate Follow-Up Interval for 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 X Care Coordinatio n Participation by a 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 CMS/ QIP X XCMS-1590-P 465

Reporting MechanismNQF/PQRSNew Measure National Quality Strategy Domain Measure Title and Description ¥Measure StewardPQRS ClaimsPQRS Qualified RegistryPQRS Qualified EHRCMS-SelectedGPRO(web interface)*Measures GroupsOther Quality ReportingPrograms

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. Partic ipation 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 0670/ TBD X Efficient Use of Healthcare Resources Cardiac Stress Imaging Not Meeting Appropriate Use Criteria: Preoperative Evaluative in Low-Risk Surgery Patients: Percentage of stress single-photon emission computed tomography (SPECT) myocardial perfusion imaging (MPI), stress echo, cardiac A CC XCMS-1590-P 466

Reporting MechanismNQF/PQRSNew Measure National Quality Strategy Domain Measure Title and Description ¥Measure StewardPQRS ClaimsPQRS Qualified RegistryPQRS Qualified EHRCMS-SelectedGPRO(web interface)*Measures GroupsOther Quality ReportingPrograms

computed tomography angiography (CCTA), or cardiovascular magnetic resonance (CMR) performed in low risk surgery patients for preoperative evaluation 0671/ TBD X Efficient Use of Healthcare Resources 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) and stress echo performed routinely after percutaneous cardiology intervention (PCI), with reference to timing of test after PCI and symptom status A CC X

0672/ TBD X Efficient Use of Healthcare Resources Cardiac Stress Imaging Not Meeting Appropriate Use Criteria: Testing in Asyptomatic, Low-Risk Patients: Percentage of all stress single-photon emission computed tomography (SPECT) myocardial perfusion A CC XCMS-1590-P 467

Reporting MechanismNQF/PQRSNew Measure National Quality Strategy Domain Measure Title and Description ¥Measure StewardPQRS ClaimsPQRS Qualified RegistryPQRS Qualified EHRCMS-SelectedGPRO(web interface)*Measures GroupsOther Quality ReportingPrograms

imaging (MPI), stress echo, cardiac computed tomography angiography (CCTA), and cardiovascular magnetic resonance (CMR) performed in asymptomatic, low coronary heart disease (CHD) risk patients for intial detection and risk assessment TBD/ TBD X Clinical Process/ Effectivenes s Adult Major Depressive Disorder: Coordination of Care of Patients with Co-Morbid Conditions - Timely Follow-Up: Percentage of medical records of patients aged 18 years and older with a diagnosis of MDD and a diagnosed co-morbid condition being treated by another physician with communication to the other physician treating the co-morbid condition A MAP CPI X

TBD/ TBD X Care Coordinatio n Coordination of Care of Patients with Co-Morbid Conditions - Timely Follow-Up (Paired Measure): Percentage of medical records of patients aged 18 years and older with a diagnosis of major depressive disorder A MAP CPI XCMS-1590-P 468

Reporting MechanismNQF/PQRSNew Measure National Quality Strategy Domain Measure Title and Description ¥Measure StewardPQRS ClaimsPQRS Qualified RegistryPQRS Qualified EHRCMS-SelectedGPRO(web interface)*Measures GroupsOther Quality ReportingPrograms

(MDD) and a diagnosed co-morbid condition with communication to anotherphysician treating the comorbid condition who have a response from the other physician within 45 days of original communication OR who have a follow-up attempt within 60 days of original communication by the physician treating MDD to elicit a response from the other physician 1525/ TBD X Patient Safety Atrial Fibrillation and Atrial Flutter: Chronic Anticoagulation Therapy: Percentage of patients aged 18 and older with nonvalvular AF or atrial flutter at high risk for thromboembolism, according to CHADS2 risk stratification, who were presecribed warfarin or another oral anticoagulant drug that is FDA approved for the prevention of thromboembolism during the 12-month reporting period A MA X X HITE CH

TBD/ TBD X Clinical Process/ Effectivenes Pediatric End-Stage Renal Disease Measure (AMA/ASPN): Pediatric A MA/AS P N X XCMS-1590-P 469

Reporting MechanismNQF/PQRSNew Measure National Quality Strategy Domain Measure Title and Description ¥Measure StewardPQRS ClaimsPQRS Qualified RegistryPQRS Qualified EHRCMS-SelectedGPRO(web interface)*Measures GroupsOther Quality ReportingPrograms

s 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 1667/ TBD X Clinical Process/ Effectivenes s Pediatric Kidney Disease: ESRD Patients Receiving Dialysis: Hemoglobin Level <10g/dL: Percentage of calendar months within a 12-month period during which patients aged 17 years and younger with a diagnosis of ESRD receiving hemodialysis or peritoneal dialysis have a Hemoglobin level <10 g/dL A MA X X

*Measures that can be reported using the GPRO web interface. † These measures can only be reported by participants using the GPRO. They are not available for reporting for individual Eligible Professionals using this reporting method. ¥ Titles and descriptions in this table are aligned with proposed 2013 PQRS Electronic Health Records (EHR) measure titles, and may differ from existing measures in other programs. Please reference the National Quality Forum (NQF) and PQRS numb ers for clarification.CMS-1590-P 470

Beginning with reporting peri ods occurring in 2014, we are proposing the following 45 individual quality measures specified in Ta ble 33 available for reporting under the PQRS: TABLE 33: Proposed PQRS Individual Qua lity Measures Available for Reporting via Claims, Registry, EHR and/or the GPRO We b-Interface for 2014 and Beyond That Were NOT Available for Reporting under the 2012 PQRS Reporting MechanismNQF/PQRS National Quality Strategy Domain Measure Title and Description ¥Measure StewardPQRS ClaimsPQRS Qualified RegistryPQRS Qualified EHRCMS-Selected GPRO* (webinterface)*Measures GroupsOther Quality Reporting Programs

N/A/ TBD Clinical Process/ Effectivene ss Preventive Cardiology Composite:

• Blood Pressure at Goal: Percentage of patients in the sample whose most recent blood pressure reading was at goal

• 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

• 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 three-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 three-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 three-month grace period) for patients with < 1 risk ABIM XCMS-1590-P 471

Reporting MechanismNQF/PQRS National Quality Strategy Domain Measure Title and Description ¥Measure StewardPQRS ClaimsPQRS Qualified RegistryPQRS Qualified EHRCMS-Selected GPRO* (webinterface)*Measures GroupsOther Quality Reporting Programs

factor for CHD)

• 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

• 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 deat h or MI is correctly assessed and documented

• Counseling for Diet and Physical Activity: Percentage of patients in the sample who received dietary and physical activity counseling

• 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%

• 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 N/A/ TBD Care Coordinati on Total Knee Replacement: Coordination of Post Discharge Care: Percentage of patients undergoing total knee replacement who received written instructions for post AAHKS/AMAPCPI XCMS-1590-P 472

Reporting MechanismNQF/PQRS National Quality Strategy Domain Measure Title and Description ¥Measure StewardPQRS ClaimsPQRS Qualified RegistryPQRS Qualified EHRCMS-Selected GPRO* (webinterface)*Measures GroupsOther Quality Reporting Programs

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 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 days prior to the procedure including history of deep vein thrombosis (DVT), pulmonary embolism (PE), myocardial infarction (MI), arrhythmia and stroke AAHKS/AMAPCPI X

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 AAHKS/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 AAHKS/AMAPCPI X

TBD/ TBD Care Coordinati on 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 nome nclature is used in institutions computer systems AMAPCPI X

TBD/ TBD Patient Safety Radiation Dose Optimization: Cumulative Count of Potential High Dose Radiation Imaging Studies: Computed Tomography AMAPCPI XCMS-1590-P 473

Reporting MechanismNQF/PQRS National Quality Strategy Domain Measure Title and Description ¥Measure StewardPQRS ClaimsPQRS Qualified RegistryPQRS Qualified EHRCMS-Selected GPRO* (webinterface)*Measures GroupsOther Quality Reporting Programs

(CT) 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- month period prior to the current study TBD/ TBD Patient Safety 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 X

TBD/ TBD Care Coordinati on 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) form at 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 X

TBD/ TBD Care Coordinati on 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 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 AMAPCPI X

N/A/ TBD Clinical Process/ Osteoporosis Composite:

• Status of Participation in WeightABIM XCMS-1590-P 474

Reporting MechanismNQF/PQRS National Quality Strategy Domain Measure Title and Description ¥Measure StewardPQRS ClaimsPQRS Qualified RegistryPQRS Qualified EHRCMS-Selected GPRO* (webinterface)*Measures GroupsOther Quality Reporting Programs

Effectivene ss 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

• Current Level of Alcohol Use and Advice on Potentially 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 h azardous drinking who received counseling within 12 months

• 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

• Dual-Emission X-ra y 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 hadCMS-1590-P 475

Reporting MechanismNQF/PQRS National Quality Strategy Domain Measure Title and Description ¥Measure StewardPQRS ClaimsPQRS Qualified RegistryPQRS Qualified EHRCMS-Selected GPRO* (webinterface)*Measures GroupsOther Quality Reporting Programs

a DXA scan and result documented

• 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 leas t once within 12 months

• 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

• 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 N/A/ TBD Clinical Process/ Effectivene ss Osteoporosis: Status of Participation inWeight-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 X

N/A/ TBD Clinical Process/ Effectivene ss Osteoporosis: Current Level of Alcohol Use and Advice on Potentially Hazardous Drinking Prevention: Percentage of patients aged 18 and older with a diagnosis of ABIM XCMS-1590-P 476

Reporting MechanismNQF/PQRS National Quality Strategy Domain Measure Title and Description ¥Measure StewardPQRS ClaimsPQRS Qualified RegistryPQRS Qualified EHRCMS-Selected GPRO* (webinterface)*Measures GroupsOther Quality Reporting Programs

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 docume nted 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 ABIM X

N/A/ TBD Care Coordinati on 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 X

N/A/ TBD Clinical Process/ Effectivene ss Osteoporosis: Calciu m 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 X

N/A/ TBD Clinical Process/ Effectivene ss 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 X

N/A/ Clinical Osteoporosis: Pharmacologic Therapy: ABIM XCMS-1590-P 477

Reporting MechanismNQF/PQRS National Quality Strategy Domain Measure Title and Description ¥Measure StewardPQRS ClaimsPQRS Qualified RegistryPQRS Qualified EHRCMS-Selected GPRO* (webinterface)*Measures GroupsOther Quality Reporting Programs

TBD Process/ Effectivene ss 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 0060/ TBD Clinical Process/ Effectivene ss Hemoglobin A1c Test for Pediatric Patients: Percentage of pediatric patients with diabetes with a HbA1c test during the measurement period NCQA X HITECH

0108/ TBD Clinical Process/ Effectivene ss ADHD: Follow-Up Care for Children Prescribed Attention-De ficit/Hyperactivity Disorder (ADHD) Medication: The percentage of children 6 to 12 years of ageand newly prescribed attentiondeficit/hyperactivity disorder (ADHA) medication who had at least three follow-up care visits within a 10-month period, one of which was within 30 days of when the first ADHD medication was dispensed. Two rates are reported. A. Percentage of children with a prescription dispensed for ADHD medication and who had one follow-up visit with a practitioner with prescribing authority during the 30-Day Initiation Phase B. Percentage of children with a prescription dispensed for ADHD medication who remained on the medication for at least 210 days and who, in addition to the visit in the Initiation Phase, had at least two additional follow-up visits with a practitioner within 270 days (9 months) after the Initiation Phase ended NCQA X HITECH

0110/ TBD Clinical Process/ Effectivene ss 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 CQAIM H X HITECH

0403/ TBD Efficient Use of HIV/AIDS: Medical Visits: Percentage of patients, regardless of age, with a diagnosis AMA/N CQA X HITECHCMS-1590-P 478

Reporting MechanismNQF/PQRS National Quality Strategy Domain Measure Title and Description ¥Measure StewardPQRS ClaimsPQRS Qualified RegistryPQRS Qualified EHRCMS-Selected GPRO* (webinterface)*Measures GroupsOther Quality Reporting Programs

Healthcare Resources of HIV/AIDS with at least two medical visits during the measurement year with a minimum of 60 days between each visit 0608/ TBD Clinical Process/ Effectivene ss Pregnant women that had HBsAg testing: This measure identifies pregnant women who had a HBsAg (hepatitis B) test during their pregnancy Ingenix X HITECH

0710/ TBD Clinical Process/ Effectivene ss Depression Remission at Twelve Months: Adult patients age 18 and older with majordepression or dysthymia and an initial PHQ9 score > 9 who demonstrate remission at twelve 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 MNCM X HITECH

0712/ TBD Clinical Process/ Effectivene ss 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 MNCM X HITECH

1401/ TBD Population /Public Health Maternal depre ssion 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 months of life NCQA X HITECH

Not yet endors ed/ TBD Clinical Process/Eff ectiveness Hypertension: Improvement in blood pressure: Percentage of patients aged 18-85 years of age with a diag nosis of hypertension whose blood pressure improved during the measurement period CMS X HITECH

Not yet endors ed/ TBD Care Coordinati on 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 HITECH

Not yet Patient and Family Functional status assessment for knee replacement: Percentage of patients aged 18 CMS X HITECHCMS-1590-P 479

Reporting MechanismNQF/PQRS National Quality Strategy Domain Measure Title and Description ¥Measure StewardPQRS ClaimsPQRS Qualified RegistryPQRS Qualified EHRCMS-Selected GPRO* (webinterface)*Measures GroupsOther Quality Reporting Programs

endors ed/ TBD Engageme nt years and older with primary total knee arthroplasty (TKA) who completed baseline and follow-up (patient-reported) functional status assessments Not yet endors ed/ TBD Patient and Family Engageme nt 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 HITECH

Not yet endors ed/ TBD Patient and Family Engageme nt Functional status assessment for complex chronic conditions: Percentage of patients aged 65 years and olde r with heart failurewho completed initial and follow-up patientreported functional status assessments CMS X HITECH

TBD/ TBD Clinical Process/ Effectivene ss Children who have dental decay or cavities: Percentage of children ages 1-17, who have had tooth decay or cavities during the measurement period MCHB, HRSA X HITECH

TBD/ TBD Clinical Process/ Effectivene ss Primary Caries Prevention Intervention as Offered by Primary Care Providers, including Dentists: Percentage of children, age 0-20 years, who received a fluoride varnish application during the measurement period Universi ty of Minnes ota X HITECH

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 HITECH

*Measures that can be reported using the GPRO web interface. ¥ Titles and descriptions in this table are aligned with proposed 2014 Health Information Technology for Economic and Clinical Health (HITECH) measure titles, and may differ from existing measures in other programs. Please reference the National Quality Forum (NQF ) and PQRS numbers for clarification. We also note that we are not proposing to in clude the following 9 measures specified in

Table 34 for 2014.CMS-1590-P 480

TABLE 34: Measures that are Not Proposed to be Included in the PQRS Measure Set for 2014 and Beyond Reporting MechanismNQF/PQRS National Quality Strategy Domain Measure Title and Description ¥Measure StewardPQRS ClaimsPQRS Qualified RegistryPQRS Qualified EHRCMS-Selected GPRO (webinterface)*Measures GroupsOther Quality Reporting Programs

0388/ 105 Patient Safety Prostate Cancer: Three Dimensional (3D) Radiotherapy: Percentage of patients, regardless of age, with a diagnosis of clinically localized prostate cancer receiving external beam radiotherapy as a primary therapy to the prostate with or without nodal irradiation (no metastases; no salvage therapy) who receive three-dimensional conformal radiotherapy (3D-CRT) or intensity modulated radiation therapy (IMRT) AMAPCPI X X

AQA adopte d/ 173 Population/ 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 AMAPCPI X X X X

0084/ 200 Clinical Process/ Effectivene ss 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 AMAPCPI/A CCF/A HA X

0013/ 237 Clinical Process/ Effectivene ss Hypertension (HTN): Blood Pressure Measurement: Percentage of patient visits for patients aged 18 years and older with a diagnosis of HTN with blood pressure (BP) recorded AMAPCPI X

0012/ 306 Population/ 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 AMAPCPI X

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 im mune globulin at 26-30 weeks gestation AMAPCPI X

0027/ Population/ Smoking and Tobacco Use Cessation, NCQA XCMS-1590-P 481

Reporting MechanismNQF/PQRS National Quality Strategy Domain Measure Title and Description ¥Measure StewardPQRS ClaimsPQRS Qualified RegistryPQRS Qualified EHRCMS-Selected GPRO (webinterface)*Measures GroupsOther Quality Reporting Programs

308 Public Health 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 0326/4 7 Care Coordinati on Advanced Care Plan: Percentage of patients aged 65 years and older who have an advanced care plan or surrogate decision maker documented in the medical record or documentation in the medical record that an advanced care plan was discussed but the patient did not wish or was not able to name a surrogate decision maker or provide an advanced care plan AMAPCPI/ NCQA X

0575/ 313 Clinical Process/ Effectivene ss 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% NCQA X

*Measures that can be reported using the GPRO web interface. ¥ Titles and descriptions in this table are aligned with the proposed 2013 EHR Pilot measure titles, and may differ from existing measures in other programs. Please refe rence the National Quality Forum (NQF) and PQRS numbers for clarification.For the 2012 PQRS, the PQRS aligned the measures the program had available for EHRbased reporting with the EHR measures available for reporting under the EHR Incentive Program (76 FR 73364) and CMS proposes to reta in those measures for 2013 and beyond. In fact, we are proposing to add or remove measures available for EHR-base d reporting that align with what has been proposed for reporting under the EHR Incentive Program for CY 2014 (77CMS-1590-P 482

FR 13746). We also intend to align the PQRS m easure set with other CMS programs such as the

Value-based Modifier and Medica re Shared Savings Program. As indicated in Tables 29 through 34, we ar e proposing a total of 264 measures in 2013. Of these proposed measures, we note that 250 of these measures were measures previously established for reporting under th e 2012 PQRS. 14 of these proposed measures are newly proposed in 2013. In 2013, we are also proposing to retire 14 measures that were previously established for reporting under the 2012 PQRS. In 2014, we are proposing 34 additional new measures that were not previously establishe d for reporting under the 2012 PQRS and proposing

to retire 8 measures that were previously established for re porting under the 2012 PQRS. For Table 31, which specifies the tables we are not proposing to retain in the PQRS measure set for 2013 and beyond, we are not propos ing the following measures for the following

reasons: (1) Stroke and Stroke Rehabilitation: Computed Tomography (CT) or Magnetic Resonance Imaging (MRI) Reports : We are not proposing that th is measure be because the measure is no longer endorsed by NQF and therefor e does not satisfy the requirement for PQRS to provide consensus-based quality measures under section 1848(k)(2 )(C)(i) of the Act. Although section 1848(k)(2)( C)(ii) of the Act provides an exception to proposing PQRS measures endorsed by the NQF, we are not exerci sing our authority to use this exception. The measure was not recommended for reporting by th e Measure Application Partnership and we agree with the Measure Applications Partnershi p’s (MAP) assessment. More information on the

MAP’s assessment can be found in the “ MAP Pre-Rulemaking Report: Input on Measures Under Consideration by HHS for 2012 Rulemaking ” available at http://www.qualityforum.org/Setting_Priorit ies/Partnership/MAP_Final_Reports.aspx. (2) Emergency Medicine: Community-Acquired Pn eumonia (CAP): Assessment of OxygenCMS-1590-P 483

Saturation : The measure was not recommended for repor ting by the MAP and we agree with the

MAP’s assessment. More information on th e MAP’s assessment can be found in the “ MAP PreRulemaking Report: Input on Measures Unde r Consideration by HHS for 2012 Rulemaking ”

available at http://www.qualityforum.org/Setting_Priorit ies/Partnership/MAP_Final_Reports.aspx. (3) Emergency Medicine: Community-Acqui red Pneumonia (CAP): Assessment of Mental Status; Acute Otitis Externa (AOE): Pain Assessment : The measure was not recommended for reporting by the MAP and we agree with the MAP’s assessment. More

information on the MAP’s assessment can be found in the “ MAP Pre-Rulemaking Report: Input

on Measures Under Considera tion by HHS for 2012 Rulemaking ” available at http://www.qualityforum.org/Setting_Priorit ies/Partnership/MAP_Final_Reports.aspx. (4) Carotid Endarterectomy: Use of Patch During Conventional Carotid Endarterectom : The measure was not recommended for reporting by the MAP and we agree with the MAP’s

assessment. More information on the MAP’s assessment can be found in the “ MAP PreRulemaking Report: Input on Measures Unde r Consideration by HHS for 2012 Rulemaking ”

available at http://www.qualityforum.org/Setting_Priorit ies/Partnership/MAP_Final_Reports.aspx. (5) Chronic Wound Care: Use of Compression System in Patients with Venous Ulcers : The measure was not recommended for reporting by the MAP and we agree with the MAP’s

assessment. More information on the MAP’s assessment can be found in the “ MAP PreRulemaking Report: Input on Measures Unde r Consideration by HHS for 2012 Rulemaking ”

available at http://www.qualityforum.org/Setting_Priorit ies/Partnership/MAP_Final_Reports.aspx. (6) Referral for Otologic Evalua tion for Patients with Histor y of Active Drainage fromCMS-1590-P 484

the Ear Within the Previous 90 Days : The measure was not recommended for reporting by the MAP and we agree with the MAP’s assessment. More information on the MAP’s assessment

can be found in the “ MAP Pre-Rulemaking Report: Input on Measures Under Consideration by HHS for 2012 Rulemaking ” available at http://www.qualityforum.org/Setting_Priorit ies/Partnership/MAP_Final_Reports.aspx. (7) Referral for Otologic Evaluation for Patie nts with a History of Sudden or Rapidly Progressive Hearing Loss : The measure was not recommended for reporting by the MAP and we agree with the MAP’s assessment. More information on the MAP’s assessment can be found in

the “ MAP Pre-Rulemaking Report: Input on Measur es Under Consider ation by HHS for 2012 Rulemaking ” available at http://www.qualityforum.org/Setting_Priorit ies/Partnership/MAP_Final_Reports.aspx.

. (8) Heart Failure: Patient Education; Func tional Communication Me asure - Motor Speech (9) Coronary Artery Disease (CAD) : Symptom and Activity Assessment : The measure was not recommended for reporting by the MAP a nd we agree with the MAP’s assessment.

More information on the MAP’s assessment can be found in the “ MAP Pre-Rulemaking Report: Input on Measures Under Consid eration by HHS for 2012 Rulemaking ” available at http://www.qualityforum.org/Setting_Priorit ies/Partnership/MAP_Final_Reports.aspx. (10) Pregnancy Test for Fema le Abdominal Pain Patients : The measure was not recommended for reporting by the MAP and we agree with the MAP’s assessment. More

information on the MAP’s assessment can be found in the “ MAP Pre-Rulemaking Report: Input

on Measures Under Considera tion by HHS for 2012 Rulemaking ” available at http://www.qualityforum.org/Setting_Priorit ies/Partnership/MAP_Final_Reports.aspx. (11) We also decline to propose the m easure titled “Health Information Technology (HIT): Adoption/Use of Electroni c Health Records (EHR)” again for the 2013 PQRS because ofCMS-1590-P 485

our desire to align with the EHR Incentive Progr am. In addition, we believe that, since we anticipate that most eligible professionals repo rting via EHR will also participate in the EHR Incentive Program, we believe it is redundant to ha ve an eligible professional report on whether or not s/he has adopted an EHR. (12) We are not proposing the measure titled “Hypertension (HTN): Plan of Care” again for 2013 because this measure is being retired by its measure owner. For the measures we are not proposing to include in PQRS beginning in 2014 in Table 34, we did not propose the Prostate Cancer : Three Dimensional (3D) Radiotherapy; Hypertension (HTN): Blood Pressure Measur ement; and Prenatal Care: Anti-D Immune Globulin measures (which are described in detail above in Table 34) for 2014 and beyond because the measures will be retired by its meas ure owners. We are proposing to retire the measure titled “Preventive Care and Screening: Unhealthy Alcohol Use – Screening” because

this measure was recommended for removal from reporting by the M easure Applications Partnership. We are proposing to retire the measure titled “Hear t Failure: Warfarin Therapy for

Patients with Atrial Fibrillation” because eviden ce suggests that treatment s other than Warfarin have proven more effective to treat Heart Failure . Lastly, we did not propose to retain the measures titled “Smoking and Tobacco Use Cessa tion, 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 St rategies” and “Advanced Care Plan” for reporting via the EHR-based reporting mechanis ms beginning in 2014 to align with the EHR Incentive Program. As indicated in Tables 30 and 32, we are pr oposing a total of 212 measures for available for reporting beginning in 2013. Beginning 2014, we are propos ing that 210 measures be available for reporting under PQRS . As indicated previously, these proposed measures areCMS-1590-P 486

classified under 6 domains. (1) Patient safety . We are proposing 21 measures under the patient safety domain available for reporting in PQRS beginning in 201 3 or 2014. Of these measures, the following 18 measures are NQF-endorsed, and therefore satis fy the requirement that PQRS provide consensus-based measures for reporting unde r section 1848(k)(2)(C )(i) of the Act.

● Perioperative Care: Timing of Antibiot ic Prophylaxis – Ordering Physician.

● Perioperative Care: Selection of Prophylac tic Antibiotic – First OR Second Generation Cephalosporin.

● Perioperative Care: Discontinuation of Prophylactic Antibiotics (Non-Cardiac).

● Perioperative Care: Venous Thromboembo lism (VTE) Prophylaxis (When Indicated in ALL Patients) Perioperative Care.

● Perioperative Care: Discontinuation of Pr ophylactic Antibiotics (C ardiac Procedures).

● Medication Reconciliation: Reconciliation Af ter Discharge from an Inpatient Facility.

● Prevention of Catheter-Related Bloods tream Infections (CRBSI): Central Venous Catheter (CVC) Insertion Protocol.

● Prostate Cancer: Three Di mensional (3D) Radiotherapy.

● Documentation of Current Medi cations in the Medical Record.

● Prevention of Catheter-Related Bloods tream Infections (CRBSI): Central Venous Catheter (CVC) Insertion Protocol.

● Medication Reconciliation: Reconciliation Af ter Discharge from an Inpatient Facility.

● Perioperative Care: Discontinuation of Prophyl actic Antibiotics (Car diac Procedures).

● Perioperative Care: Timely Administrati on of Prophylactic Pare nteral Antibiotics.

● Perioperative Care: Venous Thromboembo lism (VTE) Prophylaxis (When Indicated in ALL Patients).CMS-1590-P 487

● Perioperative Care: Discontinuation of Prophylactic Antibiotics (Non-Cardiac).

● Cataracts: Complications within 30 Days Following Cataract Surgery Requiring Additional Surgical Procedures.

● Perioperative Temperature Management.

● Thoracic Surgery: Pulmonary Function Te sts Before Major Anatomic Lung Resection (Pneumonectomy, Lobectomy, or Formal Segmentectomy) The following 3 measures that are classified under the patient safety domain are not NQF-endorsed. For these measures, we are exer cising our exception auth ority under section 1848(k)(2)(C)(ii) of the Act to propose these measures for reporting under PQRS for the following reasons:

● Falls: Risk Assessment. We are proposing to include this measur e under our authority under section 1848(k)(2)(C)(ii) to adopt a measure endorsed by the AQA alliance.

● Elder Maltreatment Screen and Follow-Up Plan. We are proposi ng to include this measure under our authority under section 1848(k)(2)(C )(ii) to adopt a m easure endorsed by the AQA alliance.

● Image Confirmation of Successful Exci sion of Image–Localized Breast Lesion. (2) Patient and Family Engagement . We are proposing 5 measur es available for reporting in PQRS under the patient and family engage ment domain beginning in 2013 or 2014. Of these measures, the following 4 measures are NQF-endorse d, and therefore satisfy the requirement that PQRS provide consensus-based measures for reporti ng under section 184 8(k)(2)(C)(i) of the Act.

● Oncology: Medical and Radia tion – Plan of Care for Pain.

● Oncology: Medical and Radiati on – Pain Intensity Quantified.

● Osteoarthritis (OA): F unction and Pain Assessment.

● Urinary Incontinence: Plan of Care for Urinary Incontinence in Women Aged 65CMS-1590-P 488

Years and Older. The following measure that is classified under the patient and family engagement domain is not NQF-endorsed: Cataracts: Patient Satisfacti on within 90 Days Following Cataract Surgery. We are exercising our exception au thority under section 1848(k)(2 )(C)(ii) of the Act to propose this measures for reporting under PQRS because this measure fills a measure satisfaction gap in the proposed PQRS measure set. (3) Care Coordination . We are proposing 38 measures available for reporting in PQRS under the care coordination domain beginni ng in 2013 or 2014. Of these measures, the following 26 measures are NQF-endorsed, and ther efore satisfy the requ irement that PQRS provide consensus-based measures for reporting under section 1848(k)(2)(C )(i) of the Act.

● Osteoporosis: Communication with the Physician Managing On-going Care PostFracture of Hip, Spine or Distal Radius fo r Men and Women Aged 50 Years and Older.

● Advanced Care Plan.

● Adult Kidney Disease: Hemodialysis Adequacy: Solute.

● Adult Kidney Disease: Peritone al Dialysis Adequacy: Solute.

● Acute Otitis Externa (AOE): Systemic Antimicrobial Therapy – Avoidance of.

● Melanoma: Coordination of Care.

● Primary Open-Angle Glaucoma (POAG): Re duction of Intraocular Pressure (IOP) by 15 percent OR Documentati on of a Plan of Care.

● Nuclear Medicine: Correlation with Ex isting Imaging Studies for All Patients Undergoing Bone Scintigraphy.

● Endoscopy & Polyp Surveillance: Colonoscopy Interval for Patients with a History of Adenomatous Polyps – Avoidance of Inappropriate Use.

● Functional Communication Measur e - Spoken Language Comprehension.CMS-1590-P 489

● Functional Communicati on Measure – Attention.

● Functional Communication Measure – Memory.

● Functional Communication Measure – Reading.

● Functional Communication Meas ure - Spoken Language Expression.

● Functional Communication Measure – Writing.

● Functional Communicati on Measure – Swallowing.

● Functional Deficit: Change in Risk-Adjus ted Functional Status for Patients with Knee Impairments.

● Functional Deficit: Change in Risk-Adjus ted Functional Status for Patients with Hip Impairments.

● Functional Deficit: Change in Risk-Adjus ted Functional Status for Patients with Lower Leg, Foot or Ankle Impairments.

● Functional Deficit: Change in Risk-Adj usted Functional Status for Patients with Lumbar Spine Impairments.

● Functional Deficit: Change in Risk-Adj usted Functional Status for Patients with Shoulder Impairments.

● Functional Deficit: Change in Risk-Adj usted Functional Status for Patients with Elbow, Wrist or Hand Impairments.

● Functional Deficit: Change in Risk-Adjus ted Functional Status for Patients with Neck, Cranium, Mandible, Thoracic Spine, Ribs, or Other General Ort hopedic Impairments.

● Radiology: Reminder System for Mammograms.

● Biopsy Follow-Up.

● Endoscopy and Polyp Surveillance: Appr opriate Follow-Up Interval for Normal Colonoscopy in Average Risk Patients.CMS-1590-P 490

● Participation by a Physician or Other Clin ician in a Systematic Clinical Database Registry that Includes Consensus Endorsed Quality. Although the following 3 measures classified under the care coordination domain are not NQF-endorsed, we are exercising our exception aut hority under section 1 848(k)(2)(C)(ii) of the Act to propose these measures for reporting in PQRS because these measures have been reviewed by the AQA:

● Functional Outcome Assessment.

● Rheumatoid Arthritis (RA) : Glucocorticoid Management.

● Falls: Plan of Care. The following 8 measures that are classified under the care coordina tion domain are also not NQF-endorsed. We are exercising our excep tion authority under section 1848(k)(2)(C)(ii) of the Act to propose this measures for reporting under PQRS because these measures fills gaps in assessing care coordination in th e proposed PQRS measure set.

● Referral for Otologic Evaluation for Patien ts with Congenital or Traumatic Deformity

of the Ear.

● Surveillance after Endova scular Abdominal Aortic Aneurysm Repair (EVAR).

● Rate of Open Elective Repair of Small or Moderate Abdominal Aortic Aneurysms (AAA) without Major Complications (Disch arged to Home by Post-Operative Day #7)

● Rate of Elective Endovascular Aortic Repair (EVAR) of Small or Moderate Abdominal Aortic Aneurysms (A AA) without Major Complicati ons (Discharged to Home by Post- Operative Day #2).

● Rate of Carotid Endarterectomy (CEA) for Asymptomatic Patients, without Major Complications (Discharged to Home Post-Operative Day #2).

● Referral for Otologic Evaluation for Pa tients with Acute or Chronic Dizziness.CMS-1590-P 491

● CG-CAHPS Clinician/Group Survey.

● Coordination of Care of Patients with Co-Morbid Conditions - Timely Follow-Up (Paired Measure). (4) Clinical Process/Effectiveness . We are proposing 127 measures available for reporting under the clinical pro cess/effectiveness domain in PQRS beginning in 2013 or 2014. Of these measures, the following 97 measures are NQF-endorsed, and therefore satisfy the requirement that PQRS provide consensus- based measures for reporting under section 1848(k)(2)(C)(i) of the Act.

● Diabetes Mellitus: Hemoglobin A1c Poor Control in Di abetes Mellitus.

● Diabetes Mellitus: Low De nsity Lipoprotein (LDL-C) Cont rol in Diabet es Mellitus.

● Diabetes Mellitus: High Blood Pressu re Control in Diabetes Mellitus.

● Heart Failure: Angioten sin-Converting Enzyme (ACE) Inhibitor or Angiotensin Receptor Blocker (ARB) Therapy for Left Ventricular Systolic Dysfunction (LVSD).

● Coronary Artery Diseas e (CAD): Antiplatelet Therapy.

● Coronary Artery Disease (CAD): Beta-Blocker Therapy for CAD Patients with Prior Myocardial Infarction (MI).

● Heart Failure: Beta-Blocker Therapy for Left Ventricular Systolic Dysfunction (LVSD).

● Anti-depressant medication management: (a) Effective Acute Phase Treatment, (b)

Effective Continuation Phase Treatment.

● Primary Open Angle Glaucoma (POAG): Optic Nerve Evaluation.

● Age-Related Macular Degeneration (AMD): Dilated Macular Examination.

● Diabetic Retinopathy: Documentation of Presence or Absence of Macular Edema and Level of Severity of RetinopathyCMS-1590-P 492

● Diabetic Retinopathy: Communication with the P hysician Managing On-going

Diabetes Care.

● Aspirin at Arrival for Acut e Myocardial Infarction (AMI).

● Stroke and Stroke Reha bilitation: Deep Vein Thrombosis (DVT) Prophylaxis for Ischemic Stroke or Intracranial Hemorrhage.

● Stroke and Stroke Rehabilitation: Discharged on Antithrombotic Therapy.

● Stroke and Stroke Reha bilitation: Anticoagulant Therapy Prescribed for Atrial Fibrillation (AF) at Discharge.

● Stroke and Stroke Rehabilita tion: Screening for Dysphagia.

● Stroke and Stroke Rehabilitatio n: Rehabilitation Services Ordered.

● Screening or Therapy for Osteoporosis for Women Aged 65 Years and Older.

● Osteoporosis: Management Following Fracture of Hip, Spine or Distal Radius for Men and Women Aged 50 Years and Older.

● Osteoporosis: Pharmacologic Therapy for Men and Women Aged 50 Years and Older.

● Coronary Artery Bypass Graft (CABG): Use of Internal Mammary Artery (IMA) in Patients with Isolated CABG: Surgery.

● Coronary Artery Bypass Graft (CABG): Pr eoperative Beta-Blocker in Patients with Isolated CABG Surgery.

● Urinary Incontinence: Assessment of Presen ce or Absence of Urinary Incontinence in Women Aged 65 Years and Older.

● Urinary Incontinence: Characterization of Urinary Incontinence in Women Aged 65

Years and Older.

● Chronic Obstructive Pulmonary Di sease (COPD): Spirometry Evaluation.

● Chronic Obstructive Pulmonary Di sease (COPD): Bronchodilator Therapy.CMS-1590-P 493

● Asthma: Pharmacologic Therapy for Persistent Asthma.

● Emergency Medicine: 12-Lead Electro cardiogram (ECG) Performed for NonTraumatic Chest Pain.

● Emergency Medicine: 12-Lead Electro cardiogram (ECG) Performed for Syncope.

● Emergency Medicine: Community-Ac quired Pneumonia (CAP): Vital Signs.

● Emergency Medicine: Community-Acquire d Pneumonia (CAP): Empiric Antibiotic.

● Asthma: Assessment of Asthma Control.

● Hematology: Myelodysplastic Syndrom e (MDS) and Acute Leukemias: Baseline.

● Hematology: Myelodysplastic Syndrome (M DS): Documentation of Iron Stores in Patients Receiving Erythropoietin Therapy.

● Hematology: Multiple Myeloma: Treatment with Bisphosphonates.

● Hematology: Chronic Lymphocytic Leuke mia (CLL): Baseline Flow CytometryBreast Cancer: Hormonal Therapy for Stage IC-IIIC Es trogen Receptor/Progesterone Receptor (ER/PR)

Positive Breast Cancer.

● Colon Cancer: Chemotherapy for Stage III Colon Cancer Patients.

● Hepatitis C: Testing for Chronic Hepatit is C – Confirmation of Hepatitis C Viremia.

● Hepatitis C: Ribonucleic Acid (RNA) Testing Befo re Initiating Treatment.

● Hepatitis C: HCV Genotype Testing Prior to Treatment.

● Hepatitis C: Antiviral Treatment Prescribed.

● Hepatitis C: HCV Ribonucleic Acid (R NA) Testing at Week 12 of Treatment.

● Hepatitis C: Counseling Regard ing Risk of Alcohol Consumption.

● Hepatitis C: Counseling Re garding Use of Contraception Prior to Antiviral Therapy.

● Acute Otitis Externa (AOE): Topical Therapy.

● Breast Cancer Resection Pathology Repor ting: pT Category (Primary Tumor) and pNCMS-1590-P 494

Category (Regional Lymph Nodes) with Histologic Grade.

● Colorectal Cancer Resection Pathology Reporting: pT Category (Primary Tumor) and pN Category (Regional Lymph No des) with Histologic Grade.

● Prostate Cancer: Adjuvant Hormonal Therap y for High-Risk Prostate Cancer Patients.

● Major Depressive Disorder (MDD): Diagnostic Evaluation.

● Major Depressive Disorder (MDD): Suicide Risk Assessment.

● Rheumatoid Arthritis (RA): Disease Modifying Anti-Rheumatic Drug (DMARD) Therapy.

● Preventive Care and Screening: Pneu monia Vaccination for Patients 65 Years and

Older.

● Preventive Care and Scr eening: Screening Mammography .

● Preventive Care and Screeni ng: Colorectal Cancer Screening.

● Coronary Artery Disease (CAD): Angiotensin-Converting Enzyme (ACE) Inhibitor or Angiotensin Receptor Blocker (ARB) Therapy for Pa tients with CAD and Diabetes and/or Left Ventricular Systolic Dysfunction (LVSD.

● Diabetes: Urine Screening.

● Diabetes Mellitus: Diabetic Foot and Ankle Care, Peripheral Neuropathy .

● Diabetes Mellitus: Diabet ic Foot and Ankle Care, Ulce r Prevention – Evaluation of

Footwear.

● Melanoma: Continuity of Care – Recall System:.

● Age-Related Macular Degeneration (AMD ): Counseling on Antioxidant Supplement.

● Osteoarthritis (OA): Assessment for Use ofAnti-Inflammatory or Analgesic Over-theCounter (OTC) Medications.

● HIV/AIDS: CD4+ Cell C ount or CD4+ Percentage.CMS-1590-P 495

● HIV/AIDS: Pneumocystis Jiroveci Pneumonia (PCP) Prophylaxis.

● HIV/AIDS: Adolescent and Adult Patie nts with HIV/AIDS Who Are Prescribed Potent Antiretroviral Therapy.

● HIV/AIDS: HIV RNA Control After Six Mo nths of Potent Antiretroviral Therapy.

● Diabetes Mellitus: Foot Exam.

● Coronary Artery Bypass Graft (CABG): Prolonged Intubation.

● Coronary Artery Bypass Graft (CAB G): Deep Sternal Wound Infection Rate.

● Coronary Artery Bypass Graft (CABG): Stroke.

● Coronary Artery Bypass Graft (C ABG): Postoperative Renal Failure.

● Coronary Artery Bypass Graft (CABG): Surgical Re-Exploration.

● Coronary Artery Bypass Graft (CABG): Antiplatelet Medications at Discharge.

● Coronary Artery Bypass Graft (CABG): Be ta-Blockers Administered at Discharge.

● Coronary Artery Bypass Graft (CABG) : Anti-Lipid Treatment at Discharge.

● Hemodialysis Vascular Access Decision -Making by Surgeon to Maximize Placement of Autogenous Arterial Venous (AV) Fistula.

● Stroke and Stroke Rehabil itation: Thrombolytic Therapy.

● Cataracts: 20/40 or Better Visual Acuity within 90 Days Following Cataract Surgery.

● Oncology: Cancer Stage Documented.

● Radiology: Stenosis Measurem ent in Carotid Imaging Reports.

● Coronary Artery Dise ase (CAD): Lipid Control.

● Heart Failure: Left Ventricular Ejection Fraction (LVEF) Assessment.

● Ischemic Vascular Disease (IVD): Blood Pressure Management Control.

● Ischemic Vascular Disease (IVD): Use of Aspirin or Another Antithrombotic.

● HIV/AIDS: Sexually Transmitted Disease Screening for Chlamydia and Gonorrhea.CMS-1590-P 496

● HIV/AIDS: Screening for High Risk Sexual Behaviors.

● HIV/AIDS: Screening for Injection Drug Use.

● HIV/AIDS: Sexually Transmitted Disease Screening for Syphilis.

● Heart Failure (HF): Left Ve ntricular Function (LVF) Testing.

● Thoracic Surgery: Record ing of Performance Status Prior to Lung or Esophageal

Cancer Resection.

● Hypertension (HTN): Cont rolling High Blood Pressure.

● Ischemic Vascular Disease (IVD): Comple te Lipid Panel and Low Density Lipoprotein (LDL-C) Control.

● Cardiac Rehabilitation Patient Re ferral from an Outpatient Setting.

● Anticoagulation for Acute Pulmonary Embolus Patients.

● Ultrasound Determination of Pregnancy Location for Pregnant Patients withRh Immunoglobulin (Rhogam) for Rh-Neg ative Pregnant Women at Risk of Fetal Blood Exposure.

● Pediatric Kidney Disease: ESRD Patie nts Receiving Dialysis: Hemoglobin Level <10g/dL. We are proposing 29 measures for inclusion in the PQRS measure set under the clinical process domain in 2013/2014 that are not NQF -endorsed. Although the following 11 measures

classified under the clinical domain are not NQF-endorsed, we are exercising our exception authority under section 1848(k)(2 )(C)(ii) of the Act to propose th ese measures for reporting in PQRS because these measures have been reviewed by the AQA:

● Adult Kidney: Disease Laborat ory Testing (Lipid Profile).

● Adult Kidney Disease: Blood Pressure Management.

● Adult Kidney Disease: Patients On Erythropoiesis-Stimulating Agent (ESA) - Hemoglobin Level > 12.0 g/dL.CMS-1590-P 497

● Rheumatoid Arthritis (RA): Tuberculosis Screening.

● Rheumatoid Arthritis (RA): Periodic Assessment of Disease Activity.

● Rheumatoid Arthritis (RA): Functional Status Assessment.

● Rheumatoid Arthritis (RA): Assessmen t and Classification of Disease Prognosis.

● Chronic Wound Care: Use of Wound Surf ace Culture Technique in Patients with

Chronic Skin Ulcers.

● Chronic Wound Care: Use of Wet to Dry Dr essings in Patients with Chronic Skin

Ulcers.

● Substance Use Disorders: Counseling Re garding Psychosocial and Pharmacologic Treatment Options for Alcohol Dependence.

● Substance Use Disorders: Screening fo r Depression Among Patients with Substance Abuse or Dependence. The following 18 measures that are classified under the care coordina tion domain are also not NQF-endorsed. We are exercising our excep tion authority under section 1848(k)(2)(C)(ii) of the Act to propose this measures for reporting und er PQRS because these measures fill gaps in measuring clinical process in th e proposed PQRS measure set.

● Asthma: Tobacco Use: Screening - Ambulatory Care Setting.

● Asthma: Tobacco Use: Intervention - Ambulatory Care Setting.

● Coronary Artery Diseas e (CAD): Symptom Management.

● Hypertension: Blood Pressure Management.

● Barrett's Esophagus.

● Radical Prostatect omy Pathology Reporting.

● Immunohistochemical (IHC) Evaluation of Human Epiderma l Growth Factor Receptor 2 Testing (HER2) for Br east Cancer Patients.CMS-1590-P 498

● Statin Therapy at Discharge af ter Lower Extremity Bypass (LEB).

● Preoperative Diagnosis of Breast Cancer.

● Sentinel Lymph Node Biops y for Invasive Breast Cancer.

● Epilepsy: Seizure Type(s) and Current Seizure Frequency(ies).

● Epilepsy: Documentation of Etiology of Epilepsy or Epilepsy Syndrome.

● Epilepsy: Counseling for Women of Childbearing Potential with Epilepsy.

● Cataracts: Improvement in Patient’s Visual Function within 90 Days Following Cataract Surgery.

● Stroke and Stroke Rehabi litation: Tissue Plasminogen Ac tivator (t-PA) Considered (Paired Measure).

● Stroke and Stroke Rehabi litation: Tissue Plasminogen Activ ator (t-PA) Administered Initiated (Paired Measure) .

● Adult Major Depressive Di sorder: Coordination of Care of Patients with Co-Morbid Conditions - Timely Follow-Up.

● Pediatric End-Stage Renal Disease Meas ure (AMA/ASPN): Pediat ric Kidney Disease: Adequacy of Volume Management. (5) Population/Public Health . We are proposing 9 measur es classified under the population/public health availa ble for reporting in PQRS beginning in 2013 or 2014. Of these measures, the following 7 measures are NQF-endor sed, and therefore, satisfy the requirement that PQRS provide consensus-based measures fo r reporting under section 1848(k)(2)(C)(i) of the

Act.

● Preventive Care and Scr eening: Influenza Immunization.

● Preventive Care and Screening: Body Mass Index (BMI) Scr eening and Follow-Up.

● Pain Assessment and Follow-Up.CMS-1590-P 499

● Preventive Care and Screening: Screen ing for Clinical Depression and Follow-Up

Plan.

● Hepatitis C: Hepatitis A Vacci nation in Patients with HCV.

● Hepatitis C: Hepatitis B Vacci nation in Patients with HCV.

● Preventive Care and Screening: Tobacco Use: Screening and Cessation Intervention. Two proposed PQRS measures in the populat ion/public health domain are not NQFendorsed. Although the measure “Preventive Care and Screening: Unh ealthy Alcohol Use – Screening” classified under the population/public health domai n is not NQF-endorsed, we are exercising our exception authority under section 1848(k)(2)(C)(ii) of th e Act to propose this measure for reporting in PQRS because the meas ure have been reviewed by the AQA. The measure “Preventive Care and Screening: Scr eening for High Blood Pressure” classified under the population/public health domain is also not NQF-endorsed. However, we are exercising our exception authority under section 1848(k)(2)(C)(ii) of the Act to propose this measure for reporting under PQRS because the measures fill ga ps in assessing population/public health safety in the proposed PQRS measure set. (6) Efficiency . We are proposing 9 measures ava ilable for reporting in PQRS beginning in 2013 or 2014. Of these measures, all measur es are NQF-endorsed, and therefore satisfy the requirement that PQRS provide consensus- based measures for reporting under section 1848(k)(2)(C)(i) of the Act.

● Treatment for Children with Upper Resp iratory Infection (U RI): Avoidance of Inappropriate Use.

● Appropriate Testing for Children with Pharyngitis.

● Prostate Cancer: Avoidance of Overuse of Bone Scan for Staging Low-Risk Prostate

Cancer Patients.CMS-1590-P 500

● Antibiotic Treatment for Adults with Ac ute Bronchitis: Avoidance of Inappropriate

Use.

● Radiology: Inappropriate Use of “P robably Benign” Assessment Category in Mammography Screening.

● Melanoma: Overutilization of Imaging Studies in Melanoma.

● Cardiac Stress Imaging Not Meeting A ppropriate Use Criteria: Preoperative Evaluative in Low-Risk Surgery Patients.

● Cardiac Stress Imaging Not Meeting Appropr iate Use Criteria: Routine Testing After Percutaneous Coronary Intervention (PCI).

● Cardiac Stress Imaging Not Meeting Appropriate Use Criteria: Testing in Asyptomatic, Low-Risk Patients.

Please note that the titles of the measures ma y change slightly from CMS program and/or CMS program year based on specifications updates . We intend to continue to work toward complete alignment of measure specifica tions across programs whenever possible. (3) Proposed PQRS quality measures Available for Reporting for Group Practices Using the

GPRO Web-Interface We have previously discussed our measure proposals for group practices using the GPRO web-interface. However, in order to empha size the measures we are proposing for group practices using the GPRO web-interface, we have provided a summary of these proposed measures in the following Table 32. As indicate d in Table 35, we are proposing 18 measures for reporting under the PQRS using the GPRO web- interface for 2013 and beyond to align with the quality measures available for reporting under th e Medicare Shared Savings Program (76 FR 67890). Please note that the Medicare Shared Savi ngs Program indicates th at it established 22 measures. There is a discrepancy because th e Medicare Shared Savings Program lists theCMS-1590-P 501

Diabetes Composite measure as separate measur es, whereas we are referring to the Diabetes Composite measure as one measure in Table 35. TABLE 35: Measures Proposed to be Included in the Group Practice Reporting Option (GPRO) Web-Based Interface for 2013 and Beyond ¥NQF/PQRS GPRO Disease Module National Quality Strategy Domain Measure and Title DescriptionMeasure StewardOther QualityReporting Programs

0059/ 1 Diabetes Mellitus Clinical Process/ Effectivene ss Diabetes: Hemoglobin A1c Poor Control: Percentage of patients 18-75 years of ag e with diabetes (type 1 or type 2) who had hemoglobin A1c > 9.0% NCQA HITECH ACO

0083/ 8 Heart Failure Clinical Process/ Effectivene ss Heart Failure (HF): 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 AMAPCPI/ ACCF/A HA HITECH ACO

0097/ 46 Care Coordinati on/ Patient Safety 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 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 medical record documented AMAPCPI/ NCQA HITECH ACO

0041/ 110 Preventive 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 influe nza immunization OR who reported previous receipt of an influenza immunization AMAPCPI HITECH ACO

0043/ 111 Preventive Care Clinical Process/ Effectivene ss Pneumonia Vaccination Status for Older Adults: Percentage of patients 65 years of age and older who have ever received a pneumococcal vaccine NCQA HITECH ACO

0031/ 112 Preventive Care Clinical Process/ Effectivene ss Breast Cancer Screening: Percentage of women 40-69 years of age who had a mammogram to screen for breast cancer NCQA HITECH ACO

0034/ 113 Preventive Care Clinical Process/ Effectivene ss Colorectal Cancer Screening: Percentage of adults 50- 75 years of age who had appropriate screening for colorectal cancer NCQA HITECH ACO

0066/ 118 Coronary Artery Disease Clinical Process/ Effectivene Coronary Artery Disease (CAD): Angiotensinconverting Enzyme (ACE) I nhibitor or Angiotensin Receptor Blocker (ARB) Therapy -- Diabetes or Left AMAPCPI/ ACCF/ HITECH ACOCMS-1590-P 502NQF/PQRS GPRO Disease Module National Quality Strategy Domain Measure and Title DescriptionMeasure StewardOther QualityReporting Programs

ss Ventricular Systolic Dy sfunction (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 AHA

0421/ 128 Preventive Care Population/ Public Health Adult Weight Screening and Follow-Up: Percentage of patients aged 18 years and older with a calculated body mass index (BMI) in the past six 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 Normal Parameters: Age 65 years and older BMI ≥ 23 and < 30 Age 18-64 years BMI ≥ 18.5 and < 25 CMS/ QIP HITECH ACO

0418/ 134 Preventive Care Population/ Public Health Screening for Clinical Depression: Percentage of patients aged 12 years and older screened for clinical depression using an age appr opriate standardized tool and follow up plan documented CMS/ QIP HITECH ACO

0074/ 197 Coronary Artery Disease Clinical Process/ Effectivene ss 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 HITECH ACO

0068/ 204 Ischemic Vascular Disease Clinical Process/ Effectivene ss Ischemic Vascular Disease (IVD): Use of Aspirin or Another Antithrombotic: Percentage of patients 18 years of age and older who were discharged alive for acute myocardial infarction (AMI), coronary artery bypass graft (CABG) or percutaneous transluminal coronary angioplasty (PTCA) 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 the measurement year and who had documentation of use of aspirin or another antithrombotic during the measurement year NCQA HITECH ACO Million Hearts

0028/ 226 Preventive Care Population/ Public Health Preventive Care and Screening: Tobacco 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 counseling intervention if identified as a tobacco user AMAPCPI HITECH ACO Million Hearts

0018/ 236 Hypertens ion Clinical Process/ Controlling High Blood Pressure: Percentage of patients 18-85 years of age who had a diagnosis of NCQA HITECH ACOCMS-1590-P 503NQF/PQRS GPRO Disease Module National Quality Strategy Domain Measure and Title DescriptionMeasure StewardOther QualityReporting Programs

Effectivene ss hypertension and whose blood pressure was adequately controlled during the measurement year Million Hearts 0075/ 241 Ischemic Vascular Disease Clinical Process/ Effectivene ss Ischemic Vascular Disease (IVD): Complete Lipid Panel and LDL Control: Percentage of patients 18 years of age and older who were discharged alive for acute myocardial infarction (AMI), coronary artery bypass graft (CABG) or percutaneous transluminal angioplasty (PTCA) from January 1-November 1 of the year prior to the measur ement year, or who had a diagnosis of ischemic vascul ar disease (IVD) during the measurement year and the year prior to the measurement year and who had a complete lipid profile performed during the measurement y ear and whose LDL-C<100 mg/dL NCQA HITECH ACO Million Hearts

N/A/ 317 Preventive Care Population/ Public Health Preventive Care and Screening: Screening for High Blood Pressure: Percentage of patients aged 18 years and older who are screened for high blood pressure CMS/ QIP HITECH ACO Million Hearts 0101/ 318 Care Coordinati on/ Patient Safety Patient Safety Falls: Screening for Fall Risk: Percentage of patients aged 65 years and older who were screened for future fall risk (patients are considered at risk for future falls if they have had 2 or more falls in the past year or any fall with injury in the past year) at least once within 12 months AMAPCPI/ NCQA HITECH ACO

0729/ TBD Diabetes Mellitus Clinical Process/ Effectivene ss 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 MNCM ACO

¥ Titles and descriptions in this table are aligned with the proposed 2013 PQRS Electronic Health Records (EHR) measure titles, and may differ from existing measures in other programs. Please reference the National Quality Forum (NQF) and PQRS numb ers for clarification.

We note that, due to our desi re to align with the measures available for reporting under the Medicare Shared Savings Program, we are propos ing not to retain the 13 measures specified in Table 36 for purposes of reporting via the GPRO-web interface beginning in 2013.CMS-1590-P 504

TABLE 36: Measures Included in the 2012 PQRS Group Practice Reporting Option WebBased Interface that are Not Proposed for In clusion in the Web-Based Interface Beginning in 2013 ¥NQF/PQRS GPRO Disease Module National Quality Strategy Domain Measure Title and DescriptionMeasure StewardOther QualityReporting Programs

0064/ 2 Diabetes Mellitus Clinical Process/ Effectivene ss Diabetes Mellitus: Low Density Lipoprotein (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 control (less than 100 mg/dL) NCQA Million Hearts

0061/ 3 Diabetes Mellitus Clinical Process/ Effectivene ss Diabetes Mellitus: High Blood Pressure Control in Diabetes Mellitus: Percentage of patients aged 18 through 75 years with diabetes mellitus who had most recent blood pressure in cont rol (less than 140/90 mmHg) NCQA

0081/ 5 Heart Failure Clinical Process/ Effectivene ss Heart Failure: Angiotensin-Converting Enzyme (ACE) Inhibitor or Angiot ensin Receptor Blocker (ARB) Therapy for Left Ventricular Systolic 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/A HA

0067/ 6 Coronary Artery Disease Clinical Process/ Effectivene ss 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 AMAPCPI/ ACCF/A HA

0102/ 52 Chronic Obstructiv e Pulmonar y Disease Clinical Process/ Effectivene ss Chronic Obstructive Pulmonary Disease (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% and have symptoms who were prescribed an inhaled bronchodilator AMAPCPI

0055/ 117 Diabetes Mellitus Clinical Process/ Effectivene ss 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

0056/ 163 Diabetes Mellitus Clinical Process/ Effectivene ss Diabetes Mellitus: Foot Exam: The percentage of patients aged 18 through 75 years with diabetes who had a foot examination NCQA HITECH

0079/ 198 Heart Failure Clinical Process/ Effectivene ss 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/A HA

0082/ 199 Heart Failure Clinical Process/ Effectivene ss Heart Failure: Patient Education: Percentage of patients aged 18 years and older with a diagnosis of heart failure who were provided with patient education on disease management and health behavior changes during one or more visit(s) within 12 months CMS/ QIPCMS-1590-P 505NQF/PQRS GPRO Disease Module National Quality Strategy Domain Measure Title and DescriptionMeasure StewardOther QualityReporting Programs

0079/ 228 Heart Failure Clinical Process/ Effectivene ss Heart Failure (HF): Left Ventricular Function (LVF) Testing: Percentage of patients 18 years and older with LVF testing performed during the measurement period for patients hospitalized with a principal diagnosis of HF during the reporting period CMS/ QIP

0575/ 313 Diabetes Mellitus Clinical Process/ Effectivene ss 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% NCQA HITECH

0729/ 314 Diabetes Mellitus Clinical Process/ Effectivene ss Diabetes Mellitus: Daily Aspirin Use for Patients with Diabetes and Ischemic Vascular Disease Percentage of patients aged 18 to 75 years of age with diabetes mellitus and ischemic vascular dis ease with documented daily aspirin use during the measurement year unless contraindicated MNCM

0729/ 315 Diabetes Mellitus Clinical Process/ Effectivene ss Diabetes Mellitus: Tobacco Non Use Percentage of patients with a diagnosis of diabetes who indicated they were tobacco non- users MNCM

¥ Titles and descriptions in this table are aligned with the proposed 2013 PQRS Electronic Health Records (EHR) measure titles, and may differ from existing measures in other programs. Please reference the National Quality Forum (NQF) and PQRS numbers for clarification In addition to the measures we are proposing in Table 36, we are also proposing to have the following measure available for repor ting occurring in 2013 and beyond: 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 maki ng; Courteous and helpful offi ce staff; Care coordination; Between visit communication; Educating patients about medication adherences; and Stewardship of patient resources. We note that this surv ey measure requires a different form of data collection and analysis than th e other proposed measures in the PQRS. Therefore, for this measure only, CMS intends to administer th e survey on behalf of the group practices participating in the 2013 PQRS GPRO . In other words, CMS intends to collect the data for this measure on group practices’ behalf for CY 2013 reporting periods.CMS-1590-P 506

(4) Proposed PQRS measures groups Available for Reporting for 2013 and Beyond We propose 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 Pr evention; and Cataracts. Th ese 20 proposed measures groups were available for reporting under the PQRS in 2012. Beginning in 2013, we are proposing the oncol ogy measures groups for reporting under the PQRS that provides measures available fo r reporting related to br east cancer and colon cancer. We believe it is important to measure cancer care. We propose 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. In 2012, the PQRS included a community-ac quired pneumonia (CAP) measures group among others. We are not proposing to include th is measures group again in the PQRS measure set for the 2013 PQRS or subsequent years becau se measures contained within this measures group were not recommended for re tention by the Measure Applica tions Partnership. We are also proposing, as identified in Table 47, to change the composition of the Coronary Artery Disease (CAD) measures group from what wa s finalized for 2012. Specifically, we are proposing to remove PQRS measure #196: Cor onary Artery Disease (CAD): Symptom and Activity Assessment and replace this measure with PQRS measure #242: Coronary ArteryCMS-1590-P 507

Disease (CAD): Symptom Management in th e CAD measures group, because the measure #196 was not recommended for retention by the meas ure applications partnership. On the hand,

measure #242 was recommended for retention by the Measure Applications Partnership. Descriptions of the measures we are propos ing within each proposed measures group are provided in Tables 37 through 62. Please note that some of the proposed measures included within a proposed PQRS quality measures gr oup may also be available for reporting as an

individual measure. TABLE 37: 2013 and Beyond Proposed Measures – 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 dialated 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. TABLE 38: 2013 and Beyond Proposed Measu res – 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 AMAPCPICMS-1590-P 508

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 *This measures group is reportable through both claims and registry-based reporting TABLE 39: 2013 and Beyond Proposed Measures – 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 months AMAPCPI/ NCQA

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 six 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. 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 TABLE 40: 2013 and Beyond Proposed Measures – 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 STSCMS-1590-P 509

NQF/ PQRS Measure Title and Description Measure Developer hours 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 STS

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

TABLE 41: 2013 and Beyond Proposed Measures – 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 reportingCMS-1590-P 510

TABLE 42: 2013 and Beyond Proposed Measures – Perioperative 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, two 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 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 AMAPCPI/ 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 TABLE 43: 2013 and Beyond Proposed Measures – 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 four days or longer at the initial vi sit to the clinician for the episode of back pain NCQA

*This measures group is reportable through both claims and registry-based reporting TABLE 44: 2013 and Beyond Proposed Measures – 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/ Hepatitis C: Antiviral Treatment Prescribed: Percentage of patients aged 18 years and AMA-CMS-1590-P 511

NQF/ PQRS Measure Title and Description Measure Developer 86 older with a diagnosis of chronic hepatitis C who were prescribed at a minimum peginterferon and ribavirin therapy within the 12-month reporting period PCPI

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 counseled regarding contraception prior to the initiation of treatment AMAPCPI

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

TABLE 45: 2013 and Beyond Proposed Measures – Heart Failure (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 TABLE 46: 2013 and Beyond Proposed Measures – 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 AMAPCPI/ ACCF/AHCMS-1590-P 512

NQF/ PQRS Measure Title and Description Measure Developer documented plan of care to achieve LDL-C <100 mg/dL, including at a minimum the prescription of a statin 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 only TABLE 47: 2013 and Beyond Proposed Measures – 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 TABLE 48: 2013 and Beyond Proposed Measures – 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 AMAPCPI/ NCQACMS-1590-P 513

NQF/ PQRS Measure Title and Description Measure Developer have documentation of a plan of care 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 least once within 12 months AMAPCPI/ NCQA *This measures group is reportable through registry-based reporting only TABLE 49: 2013 and Beyond Proposed Measures – 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 TABLE 50: 2013 and Beyond Proposed Measures – Chronic Obstructive Pulmonary 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 NCQACMS-1590-P 514

NQF/ PQRS Measure Title and Description Measure Developer pneumococcal vaccine 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 TABLE 51: 2013 and Beyond Proposed Measures – Inflammatory Bowel Disease (IBD) Measures Group* 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 TABLE 52: 2013 and Beyond Proposed Measures – 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 AMAPCPI/CMS-1590-P 515

NQF/ PQRS Measure Title and Description Measure Developer an assessment of symptoms, including pres ence or absence of snoring and daytime sleepiness 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 sleep apnea who were prescribed pos itive airway pressure therapy who had documentation that adherence to positive ai rway pressure therapy was objectively measured AMAPCPI/ NCQA

*This measures group is reportable through registry-based reporting only TABLE 53: 2013 and Beyond Proposed Measures – 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 TABLE 54: 2013 and Beyond Proposed Measures – Parkinson’s Disease Measures Group*CMS-1590-P 516

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 / 290 Parkinson’s Disease: Psychiatric Diso rders 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

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 TABLE 55: 2013 and Beyond Proposed Measures – 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 ABIMCMS-1590-P 517

NQF/ PQRS Measure Title and Description Measure Developer months *This measures group is reportable through registry-based reporting only

TABLE 56: 2013 and Beyond Proposed Measures – Cardiovascular Prevention Measures Group* 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 TABLE 57: 2013 and Beyond Proposed Measures – 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 onlyCMS-1590-P 518

TABLE 58: 2013 and Beyond Proposed Measures – Oncology Measures Group*NQF/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 TABLE 59: 2014 and Beyond Proposed Measures – Osteoporosis Measures Group*

NQF/ PQRS Measure Title Measure DeveloperCMS-1590-P 519

NQF/ PQRS Measure Title Measure Developer 0046/ 39 Osteoporosis: 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) meas urement ordered or performed at least once since age 60 or pharmacologic therapy prescribed within 12 months AMA

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 TABLE 60: 2014 and Beyond Proposed Measures – Total Knee Repl acement Measures Group* NQF/ PQRS Measure Title Measure DeveloperCMS-1590-P 520

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 TABLE 61: 2014 and Beyond Proposed Measures – 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 reportingCMS-1590-P 521

TABLE 62: 2014 and Beyond Proposed Measures – 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 the preceding 12-month period (w ith a three-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 three-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 thr ee-month 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 We invite public comment on the propos ed Physician Quality Reporting System

measures groups. (5) Proposed Physician Quality Reporting Syst em Measures for Eligible Professionals and Group Practices that Report Us ing Administrative Claims for the 2015 and 2016 Payment Adjustments We are proposing the following measures in Table 63 for eligible professionals and groupCMS-1590-P 522

practices that report using ad ministrative claims for the 2015 and 2016 payment adjustments. Our proposals on how to attribute beneficiarie s to groups of physicians that elect the administrative claims option are discussed in th e value-based payment modifier in section K.

below. We considered all of the measures included in the program year 2010 individual Physician Feedback reports that can be calcula ted using administrative claims but are proposing only a subset of the measures that were include d in the program year 2010 individual Physician Feedback reports. We are proposing this subs et of measures for both the PQRS payment adjustment and the value-based modifier because we believe these measures are clinically meaningful, focus on highly prevalent conditions among beneficiaries, have the potential to differentiate physicians, and be sta tistically reliable. To the exte nt that the value-based payment

modifier finalizes other measures from the 2010 i ndividual Physician Fee dback reports that are listed in Table 65, it would be our intent to finalize those additional measures as well for purposes of the 2015 and 2016 PQRS payment adju stments so that the two programs can be aligned. As specified in Table 63, we are proposing 19 measures. Of these 19 proposed measures, 17 of these measures are NQF-endorsed and theref ore satisfying section 1848(k)(2)(C)(i) if the Act. With respect to the 2 measures that are not NQF-endorsed, “P otentially Harmful DrugDisease Interactions in the Elderly” and “Diabe tes: LDL-C Screening ,” we are exercising our exception authority under section 1848(k)(2)(C)(ii) of the Act to propose these measures for inclusion in the PQRS administrative claims measure set. Both of these measures are relevant as they address care coordination by measuring the amount of time a patient has been readmitted

and/or where their status is in the healthcare continuum followi ng hospitalization. The utilization

of the administrative claims m easures will allow PQRS to impl ement different reporting optionsCMS-1590-P 523

which capture a wider venue of participants w ithout using the traditional methods of reporting and eliminate the potential payment adjustment for non-participators. TABLE 63: Proposed Measures for Eligible Professionals and Group Practices Who Report Using Administrative Claims for the 2015 and 2016 PQRS Payment Adjustment NQF Number Measure Title Measure Steward Domain of Care 0279 Bacterial Pneumonia The number of admissions for bacterial pneumonia per 100,000 population. AHRQ Care Coordination 0281 UTI The number of discharges for urinary tract infection per 100,000 population Age 18 Years and Ol der in a one year time period AHRQ Care Coordination

0280 Dehydration The number of admissions for dehydration per 100,000 population. AHRQ Care Coordination Composite of Chronic Prev ention Quality Indicators N/A

Diabetes Composite 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 Care Coordination

0272 Short Term Diabetes complications The number of discharges for diab etes short-term complications per 100,000 Age 18 Years and Older population in a one year period. AHRQ Care Coordination

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 Care Coordination

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 Care Coordination

0275 COPD The number of admissions for chro nic obstructive pulmonary disease (COPD) per 100,000 population. AHRQ Care Coordination

0277 Heart Failure Percent of the population with admissions for CHF. AHRQ Care Coordination N/A 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 Coordination

N/A 30 Day Post Discharge Visit 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 Coordination

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

0021 Annual Monitoring for Beneficiar ies on Persistent Medications Percentage of patients 18 years of age and olde r who received at least 180 treatment days of ambulatory medication therapy for a select ther apeutic agent during the measurement year and at least one therapeutic monito ring event for the therapeutic ag ent in the measurement year. NCQA Patient Safety

0555 Lack of Monthly INR Monitoring for Beneficiaries on Warfarin Average percentage of 40-day inte rvals in which 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

0549 Pharmacotherapy Management of COPD Exacerbation Percentage of chronic obstructive pulmonary disease (COPD) exacerbations for patients 40 NCQA Clinical CareCMS-1590-P 524

NQF Number Measure Title Measure Steward Domain of Care years of age and older who had an acute inpatie nt discharge or ED encounter between January 1–November 30 of the measurement year a nd were dispensed a ppropriate medications 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 Care

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 six 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 ey e care professional in the year prior to themeasurement 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 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 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

We invite public comment on the proposed me asures for eligible professionals and group practices that report using admi nistrative claims. We seek co mment on whether these are these proposed measures. 7. Proposed Maintenance of Certification Pr ogram Incentive: Propos ed Self-Nomination Process for Entities Wishing to be Qualified for the 2013 and 2014 Maintenance of Certification Program Incentives We propose that new and previously qualified entities wishing to become qualified toCMS-1590-P 525

provide their members with an opportunity to earn the 2013 and/or 2014 Maintenance of Certification Program incentives undergo a self-n omination and qualification process. Once qualified, the entity would be ab le to submit data on behalf of its eligible professionals. For the self-nomination process, we propose that an entity wishing to be qualified for the

2013 and/or 2014 Maintenance of Certification Pr ogram incentive would be required to submit a self-nomination statement containing all of the following information via the web:

● Provide detailed information regarding th e Maintenance of Certification Program with 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 ofCMS-1590-P 526

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 year 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. For the qualification process, we propose that an entity must meet all of the following requirements to be considered for qualifica tion for purposes of the 2013 and 2014 Maintenance of Certification Program incentives:

● 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 ofCMS-1590-P 527

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 certification 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 are proposing this self-nomination and qualification process because the process is identical to the self-nomination and qualif ication process finalized for the 2011 and 2012 Maintenance of Certification Program incentives and we believe such requirements remain appropriate. As the incentives only run thr ough 2014, we believe it is important to keep the requirements consistent with what has been required for the 2011 and 2012 Maintenance of Certification Program incentives. We invite public comment on our proposed self-nomination and qualification process for entities who wish to be qualified for the 2013 and 2014 Maintenance of Certification Program incentive.

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 proposed rule, we address the additional parameters of eligible professi onals and group practices subject to a PQRS payment adjustment requesting an informal review. For eligible prof essionals 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 propose the following:

● For eligible professionals and group practices wishing to submit an informal reviewCMS-1590-P 528

related to the payment adjustment, we propose that an eligible professional electing to utilize the informal review process must request an informal review by February 28 of the year in which the payment adjustment is being applied. For exam ple, if an eligible professional requests an informal review related to the 2015 payment ad justment, the eligible professional would be required to submit his/her request for an inform al review by February 28, 2015. We believe this deadline provides ample time for eligible professi onals and group practices to discover that their respective claims are being 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 propose to ceas e application of the payment adjustment and reprocess all claims that have b een erroneously adjusted to date. We invite public comment on our proposals for the PQRS informal review process.

H. The Electronic Prescrib ing (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 contains additi onal proposals for the 2013 and 2014 eRx Incentive Program. 1. Proposed Alternative Self-N omination 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 propose an alternative submissi on mechanism for selfnomination by groups participating in the M SSP, Pioneer ACO, or PGP Demonstration. Specifically, we propose that the pa rticipating TINs within these gr oups that wish to participate in the eRx Incentive Program using the eRx GPRO must submit a self-nomination statement by sending a letter indicating its in tent to participate in the eRx Incentive Program under the eRxCMS-1590-P 529

GPRO. We also propose that the group practice must submit an XM L file describing the eligible professionals included in the group practice. We are proposing this alternative submission mechanism for group practices that are participating as groups in the MSSP, Pioneer ACO, or

PGP Demonstration because it is not technically feasible for CMS to receive this information from these group practices via the web. We invi te public comment on this proposed alternative mechanism for submitting self-nomination statemen ts and the XML file for the types of group practices identified above that want to partic ipate in the eRx Incentive Program using the eRx

GPRO. 2. The 2013 Incentive: Proposed Criterion for Be ing a Successful Electro nic Prescriber for Groups Comprised of 2-24 Eligible Professionals Selected to Participate under the eRx GPRO As stated in section III.G, we are proposing to modify §414.90(b) to define a group practice as “a single Tax Identification Number (T IN) with 2 or more elig ible professionals, as identified by their individual National Provide r (NPI), who have rea ssigned their Medicare billing rights to the TIN.” Under §414.92(b), we define a group practice as a practice that indicates its desire to partic ipate in the eRx group practice op tion and meets the definition of group practice according to the PQRS at §414.90(b), or a group practice participating in certain other Medicare programs (for example, PG P demonstration, Shared Savings Program). Therefore, since we are proposing to change th e minimum group practice size from 25 to 2, we are proposing to add another criterion for bei ng a successful electroni c reporter under the program for the 2013 Incentive (for the other crite ria we previously adopted for the ERx GPRO Reporting Option, please see 76 FR 73407). Spec ifically, we are proposing the following criterion for being a successful el ectronic prescriber for group pract ices participating in the eRx GPRO comprised of 2-24 eligible professionals for purposes of the 2013 eRx incentive: report the electronic prescribin g measure’s numerator code during a denominator-eligible encounter forCMS-1590-P 530

at least 225 times during the 12-month 2013 in centive reporting peri od (January 1, 2013— December 31, 2013). We are proposing lower crit erion for group practices participating under the eRx GPRO with 2-24 eligible professionals because we understand that their smaller sizes necessitate a lower reporting thre shold. We chose this reporting threshold because this reporting 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 2010 (75 FR 73509). We invite public comment on our proposed criterion for being a successful electronic prescriber for the 2013 incentive for groups co mprised of 2-24 elig ible professionals. 3. The 2014 Payment Adjustment: Proposed Criterion for Being a Successful Electronic Prescriber for Groups Comprised of 2-24 Eligible Professionals Selected to Participate under the

eRx GPRO As stated in section III.G, we are proposing to modify §414.90(b) to define a 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.” Under §414.92(b), we define a group practice fo r the purposes of being able to participate under the eRx GPRO as a pr actice that indicates its desire to participate in the eRx group practice option and either meets the definition of group practice according to the PQRS at §414.90(b) or is a group practice participating in certain other Medicare program s (for example, PGP demonstration, Shared Savings Program). Ther efore, since we are proposing to change the minimum group practice size from 25 to 2, we ar e proposing to add another criterion for being a successful electronic reporter und er the program for the 2014 payment adjustment (for the other criteria we previously adopted for the ER x GPRO Reporting Option, please see 76 FR 73412- 73414). Specifically, we are proposing the followi ng criterion for being a successful electronic prescriber for purposes of the 2014 payment adju stment for group practices comprised of 2-24CMS-1590-P 531

eligible professionals particip ating under the eRx GPRO: Report the electronic prescribing

measure's numerator code at least 225 times for the 6-month 2014 payment adjustment reporting period (January 1, 2013—June 30, 2013). We ar e proposing this lower criterion for group practices participating under the eRx GPRO with 2-24 eligib le professionals because we

understand that their smaller sizes necessitate a lo wer reporting threshold. In addition, we note that this reporting threshold is familiar to group practices, as this was the threshold established for group practices comprised of 11-25 eligible prof essionals that participat ed in the GPRO II in 2010 (75 FR 73509). We invite public comment on the proposed criterion for being a successful electronic prescriber for the 2014 eRx payment ad justment for the 6-month payment adjustment reporting period for group pr actices composed of 2-24 eligible professionals. 4. Proposed 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. Please note that, if a Medicare Part B claim is reopened for reprocessing, the reprocessing of cl aim does not allow an eligible professional to attach a G-code on a claim for purposes of repor ting quality measures, such as the electronic prescribing measure. Therefore, we are proposi ng to modify §414.92 to indicate that claims may not be reprocessed for the sole purpose of attaching a reporting G-code on a claim. 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 significantCMS-1590-P 532

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.

We have received feedback from stakeholde rs requesting significant hardship exemptions from application of the eRx payment adjustme nt 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 July 28, 2010 final rule titled “Medicare and Medicaid Programs; Electronic Health Reco rd Incentive Program; Final Rule,” (75 FR 44314). As a result of such feedback, we believe that in certain circumstances it may be a significant hardship for eligible professionals and group practices who are partic ipants of the EHR Incentive Program to comply with the successf ul electronic prescriber requirements of the eRx Incentive Program. Therefore, we are proposing to revise the regulation at

4 “Eligible professional” is defined for the EHR Incentive Program at 42 C.F.R. §§ 495.4, 495.100, and 495.304.CMS-1590-P 533

§414.92(c)(2)(ii)(B) to add the following two a dditional significant hardship exemption categories for the 2013 and 2014 eRx payment adjustments:

• Eligible professionals or gr oup practices who achieve meani ngful use during certain eRx payment adjustment reporting periods.

• Eligible professionals or group practices who demonstr ate intent to par ticipate in the EHR Incentive Program and adoption of Certified EHR Technology.

A. Eligible professionals or gr oup practices who achieve meani ngful use during certain 2013 and 2014 eRx payment adjustment reporting periods. Under Stage 1 of meaningful use for the EH R Incentive Program, an eligible professional is required to meet certain objectives and associ ated measures in order to achieve meaningful use. One of these objectives is for the eligible professional to generate and transmit permissible prescriptions electronica lly, and the measure of whether the eligible professional has met this objective is more than 40 per cent of all permissible prescriptions written by the eligible professional are transmitted electronically usi ng Certified EHR Technology (§495.6(d)(4)). We note that the EHR Incentive Program and the eR x Incentive Program share a common goal of encouraging electronic prescrib ing and the adoption of techno logy that enables eligible professionals to electronically prescribe. This goal is advanced under each program via the respective program requirements – the electron ic prescribing objectiv e under the EHR Incentive Program and the requirement that an EP be a “successful electronic prescriber” under the eRx Incentive Program. Indeed, both programs require that the eligible professionals indicate their electronic prescribing activity. Under the EHR Incentive Program, an eligible professional must attest to the percentage of his or her permissible prescrip tions that were generated and transmitted electronically using Certified EHR Technology during the applicable EHR reporting period, which must exceed 40 per cent. Under the eRx Incentive Program, to avoid the paymentCMS-1590-P 534

adjustment, eligible professional must be a succe ssful electronic prescrib er, which is achieved by the reporting of the eR x quality measure a certain number of instances during the applicable reporting period (each instance of reporting of the eRx quality, which includes reporting of specific quality data codes, signi fies that the professional genera ted an electronic prescription for a specified service or encounter). In most 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 In centive Program (as demonstrated via the report ing of the eRx quality measure). In addition, there seems to be no added benefit with regard to reporting (presumably lower) electronic prescribing activ ity under the eRx Incentive Program given that the identical goals (encouraging electronic pres cribing) of both programs would have been fulfilled through the eligible professional’s achiev ement of meaningful use. For those reasons, we believe it may pose a significant hardship for eligible professionals who are meaningful EHR users to additionally comply with the requireme nts of being a successful electronic prescriber under the eRx Incentive program. For the reasons stated, under this proposed significant hard ship category, we propose that individual eligible professionals (and every eligible professional member of a group practice group practice practices for the 2014 payment adjustment only) would need to achieve meaningful use of Certified EHR Technology for a continuous 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- December 31, 2012 or January1 – June 30, 2013, respectively) for the 2014 eRx payment adjustment to be eligible to request a significan t hardship exemption. We also propose that for purposes of the 2013 and 2014 eRx payment adjustments this hardship exemption category would apply to individual EPs and group practices (that is, every memb er of the group) whoCMS-1590-P 535

instead achieve meaningful use of Certified EH R Technology for an EHR reporting period that is the full CY 2012. In section III.H.5.b. below, we discuss the proposed deadlines and procedures for requesting consideration of an exemption unde r this proposed significa nt hardship exemption category. 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 finalized 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 eRxCMS-1590-P 536

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 implementing 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 participatingCMS-1590-P 537

in both programs may potentially have to adopt and implement CEHRT well in advance of their 90-day EHR reporting period in order to meet an earlier reporting peri od for the eRx Incentive Program. Therefore, for the 2013 and 2014 eRx payment adjustments, we are proposing a significant hardship exemption cat egory to address this situati on. We believe, however, that for this category it is necessary for eligible profe ssionals and group practices to show they intend to participate in the EHR Incentive Program for 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 eRx payment adjustments, we propose that eligible professionals or group practices must register to participate 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 practices (that is, every individual EP member of the group practice): (1) who have not previously adopted CEHRT or r eceived an incentive payment

under the Medicare or Medicaid EHR Incentive Programs; and (2) w ho attempt to participate in the Medicare or Medicaid EHR Incentive Progra ms from January 2, 2012 through October 15, 2012, or the effective date of the final rule (which includes the 6- month 2013 eRx payment adjustment reporting period of January 1, 2012-June 30, 2012) for the 2013 eRx payment adjustment, or during the 6 month payment adjustment reporting period for the 2014 eRx payment adjustment (January 1, 2013 through June 30, 2013). With respect to eligible professionals or group practiceswho intend to adopt EHR technology in the future or have not yet taken the steps require d in order to apply for this significant hardship exemption, we believe that mere intent to adopt CEHRT or attest at a later date does not sufficiently demonstrate that an eligible professional will adopt CEHRT toCMS-1590-P 538

participate in the Medicare or Medicaid EHR Incentive Programs. Unlike those eligible professionals who would have registered for th e Medicare or Medicaid EHR Incentive Programs and have adopted CEHRT available for immediate use, we would have to monitor and provide oversight over those eligible prof essionals who have not yet taken th ese steps to participate in the Medicare or Medicaid EHR Incentive Programs. We also do not believe that such eligible professionals or group practices would necessa rily be facing a significant hardship as contemplated in this proposed exemption category. Accordingl y, all of the proposed requirements to qualify for an exemption under this significant hardsh ip exemption category would need to be met by the time the eligible professional requests an exemption. In section III.H.5.b. below, we discuss the proposed deadline s and procedures for requesting consideration of an exemption under this propos ed significant hardship exempti on category. We invite public comment on these two proposed si gnificant hardship exemption categories for the 2013 and 2014 payment adjustments. C. Proposed Deadlines and Procedures for Requesting 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 significant hardship exemption categories for the eRx payment adjustment s (76 FR 54963). Unfortunately, with respect to submitting these proposed significant hardship exemptions for the 2013 eRx payment adjustment, it would not be operationa lly feasible to accept significant hardship exemption requests in the manner we previously established. Therefore, we propose that, in order to request a significant hardship under th e two proposed significant hardship exemption categories for the 2013 eRx payment adjustment, CMS would analyze the information provided to us in the Registration and Attestation Syst em under the EHR Incentive Program to determine whether the eligible professi onal or group practice (that is, every EP member of the groupCMS-1590-P 539

practice) has either (1) achieved meaningful use under the EHR Incentive Program during the applicable reporting periods we not ed previously, or (2) register ed to participate in the EHR Incentive Program via the Registration and Atte station system for the EHR Incentive Program (located at https://ehrincentives.cms .gov/hitech/login.action ) and adopted CEHRT, or both, if applicable. We understand that providing an elig ible professionals CEHRT product number is an optional field in the Registration Page. Please no te that if requesting a significant hardship exemption under proposed category 2, the eligible professional 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 inform ation via the Registration and Attestation system for the EHR Incentive Program, we propose that we woul d 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 Servi ces, Office of Clinical Standards and Quality, Quality Measurement and Health Assessmen t Group, 7500 Security Boulevard, Mail Stop S3- 02-01, Baltimore, MD 21244-1850. Regardless of which method is finalized for the 2013 eRx payment adjustment, we propose that eligible professionals would be requ ired to submit this signi ficant hardship requests by October 15, 2012 or the effective date of the final rule for this provision, whichever is later. For those eligible professionals who request a significant hardsh ip exemption based on achieving meaningful use under the EHR In centive Program during the 12- or 6-month reporting periods for the 2013 payment adjustment, we also propos e that the eligible professional would be required to have attested under the EHR Incentive Program by October 15 th of 2012 (or if later, the effective date of the final rule), in order to qualify for a significant hardship exemption for the 2013 payment adjustment. For those eligible professionals requesting a significant hardship exemption for the 2013 eRx payment adjustment under the second proposed significant hardshipCMS-1590-P 540

exemption category (that is, intent to particip ate in the EHR Incentive Program and adoption of CEHRT), we propose that these eligible profe ssionals who intend to pa rticipate in the EHR Incentive Program from January 1, 2011 through October 15, 2012 or the effective date of the final rule would be required to register fo r the EHR Incentive Program and adopt CEHRT by the same deadline noted above, in order to qualify for a significant hardship exemption for the 2013 eRx payment adjustment. We note that we are proposing a later dead line of October 15, 2012 (o r the effective date of the final rule, if later) for the submission of these requests because the deadline for submitting requests under other previously es tablished significant hardship exemption categories to the 2013 eRx payment adjustment (June 30, 2012) has pass ed and other similar dates we might choose would likely have passed by the time the final rule is effective. We not e that this October 15,

2012 deadline is consistent with our intent to finalize our pr oposals related to these two additional significant hardship exemptions in ear ly Fall 2012, prior to the publication of the CY 2013 Medicare PFS final rule. However, to the exte nt we are not able to finalize these proposals in the Fall 2012, please note that we may finalize the provisions related to the two proposed significant hardship exemption cate gories in the CY 2013 Medicare PFS final rule. If such is the case, we propose to extend the October 15, 20 12 deadline to the effect ive date of the CY

2013 Medicare PFS final rule. In addition, we would like to be able to process all such requests before we begin making the claims processing systems changes later this year to adjust eligible professionals’ or group practices’ payments starting on January 1, 2013. Howe ver, we anticipate that, in some cases, particularly in instances wher e eligible 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 systems updates are made to begin reducing eligible professionals’CMS-1590-P 541

and group practices’ PFS amounts in 2013. In such cas es, if we ultimately approve the eligible professional or group practice’s re quest for a significant hardsh ip exemption after January 1, 2013, we would need to reprocess all claims for se rvices furnished up to that point in 2013 that were paid at the reduced PFS amount, which we an ticipate may take several months. In order to avoid the reprocessing of claims, we encourage eligible professionals who would be submitting a significant hardship exemption re quest under these two cat egories to do so as soon as possible, rather than waiting until the deadline to submit such a request. We note that we are only proposing submi ssion of requests for significant hardship exemptions under these 2 categories under an indivi dual eligible professional level only because it is not technically feasible for us to opera tionally analyze information on the EHR Incentive Program’s Registration and Attestat ion page using the TIN, as the information stored in this system is stored by NPI. However, we seek not to preclude eligible profe ssionals currently in an eRx GPRO for 2012 from submitting requests for si gnificant hardship exemptions under these 2 proposed categories. Therefore, to allow the su bmission of significant hardship requests for the 2013 eRx payment adjustment under these 2 propos ed categories, we propose that eligible professionals within an eRx GPRO may, as indivi duals, request a signific ant hardship exemption under these 2 proposed categories. Please note, howe ver, that if an entire eRx GPRO wishes to request a significant hardship exemption under these 2 proposed cat egories, then each eligible professional in the group practice must submit a request. With respect to submitting exemption requests for the 2 proposed significant hardship exemption categories for the 2014 eRx payment adjustment, we propose the following method for submitting a request for a significant hard ship exemption: Via the Communication Support Page (which is the method established for submitting the established significant hardship exemption categories).CMS-1590-P 542

In addition, we considered accepting significan t hardship exemption requests for the 2 proposed significant hardship exemption cate gories for the 2014 eRx payment adjustment by CMS receiving eligible professional’s informa tion through the Registration and Attestation System for the EHR Incentive Program (similar to our proposed submission process for the 2013 eRx payment adjustment) and via a mailed letter to CMS using the following address: 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 invite public comme nt on these considered submission options. We propose that the deadline for submitting these significant hardship exemption requests for the 2014 eRx 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. Additio nally, and consistent with our proposal for the 2013 eRx payment adjustment, we propose that an e ligible professional or group practice (that is, all members of the practice) that achieves m eaningful use under the EHR Incentive Program during the 6- or 12-month repor ting periods for the 2014 eRx payment adjustment would be required to attest by June 30, 2013. Similarly, for eligible professionals requesting a significant hardship exemption for the 2014 eRx payment ad justment under the second proposed significant hardship exemption category (i.e ., intent to participate in the EHR Incentive Program and adoption of CEHRT), we propose that these eligib le professionals who in tend to participate in the EHR Incentive Program during the last six mont hs of 2013 would be required to register for the EHR Incentive Program and adopt CEHRT by June 30, 2013, in order to qualify for a significant hardship exemption for the 2014 eRx pa yment adjustment. We understand that these deadlines may exclude some eligib le professionals who attest or register for the EHR Incentive Program at later dates, but these deadlines are necessary in order to av oid the reprocessing ofCMS-1590-P 543

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 must still atte st to being a meaningful user by the deadline established under the EHR Incentive Program, even if such deadline falls prior to the proposed eRx Incentive program significant hardship exemp tion deadline. We invite public comment on this proposed process for submitting requests sign ificant hardship exemptions under these two proposed categories.

6. Informal Review

To better facilitate issu es surrounding the issuance of incentives and payment adjustments, we propose to establish an informal review process for the eRx Incentive Program. We are proposing an informal review process sim ilar to the informal review process established for the PQRS (76 FR 73390), because eligible professionals and group practices are already familiar with this process. The proposed informal review process, which is described below, would only be available for the 2013 eRx in centive payments and the 2014 eRx payment adjustment. For an informal review regarding the 2013 incentive, we propose 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 practice actually accesses his/her feedback report. For an informal review regarding the 2014 payment adjustment, we propose that an eligible professional or group pr actice must request an informal review by January 31, 2013. We believe this deadline provides ample time for eligible professionals and group practices to discover that their respective cl aims are being adjusted due to the 2014 payment adjustment and

seek informal review.CMS-1590-P 544

We propose that the request must be subm itted in writing and summarize the concern(s) and reasons for requesting an informal review. In its request for an informal review, eligible professional may also submit other info rmation to assist in the review. We propose that an eligible professional may re quest an informal review through the web. We believe use of the web would provide a more effi cient way for CMS to record informal review requests, as the web would guide the eligible profe ssional through th e creation of an informal review requests. For example, the web-based tool would prompt an eligib le professional of any necessary information he or she must provide. Should it be technically not feasible to receive requests for informal reviews via the web, we propos e that as eligible professional would be able to request an informal review via email. We further propose that we would make our determination and pr ovide 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 have made a determination, we propose 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, 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 propose that decisions based on the informal review would be final, and there would be no further review or appeal. We invite public comment on our proposal s for the eRx Incentive Program informal review process for the 2013 incentive and the 2014 payment adjustment.CMS-1590-P 545

a. Proposed Criteria for the PQ RS-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 (75 FR 44321), 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 product (76 FR 73422). We propose to modify §495.8 to extend this Pilot fo r the 2013 payment year as it was finalized for the 2012 payment year. We are also proposi ng to remove from §495.8(a)(2)(v) the crossreference to §495.6(d)(10) in orde r to conform with the proposed changes to §495.6(d) that were included in the EHR Incentive Program – Stag e 2 NPRM (77 FR 13698, 13702). This proposal includes the following:

● For the 2013 payment year only, EPs intending to partic ipate in the PQRS-Medicare EHR Incentive Pilot may use a PQRS qualified EHR data submission vendor product 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 for the 2012 payment year , the PQRS qualified

EHR data submission vendor would calculate th e CQMs from the EP’s CEHRT and then submitCMS-1590-P 546

the calculated results to CMS on the EP’s behalf via a secure portal for purposes of this Pilot.

● For the 2013 payment year on ly, identical to the submission process used for the Pilot in 2012 for the 2012 payment year, EPs intending to participate in the PQRS-Medicare EHR Incentive Pilot may use a PQRS qualified direct EHR product to submit CQM data directly from his or her CEHRT to CMS via a secure portal us ing the infrastructure of the PQRS EHR-based reporting mechanism. In addition, for the 2013 payment year, we are proposing to extend the use of attestation as a reporting method for th e CQM component of meaningf ul use for the EHR Incentive Program. For 2013, EPs would be able to contin ue to report by attest ation CQM results as calculated by CEHRT, as they did for 2011 and 2012. We refer reader s to the EHR Incentive Program – Stage 1 final rule for further explana tion of the CQM reporting criteria for EPs and attestation (75 FR 44386 – 44411, 44430 – 44434). We invite public comment on our proposal to extend the PQRS-Medicare EHR Incentive

Pilot and attestation as it was established for the 2012 payment year to the 2013 payment year. Please note that we are only proposing the exte nsion of the PQRS-Medicare EHR Incentive Pilot to the 2013 payment year, because Stage 2 of the EH R Incentive Program is expected to begin in 2014. The proposals for Stage 2 of the EHR Incen tive Program were provided in a standalone proposed rule published on March 7, 2012 (77 FR 13698). 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 ofCMS-1590-P 547

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 payments 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 meas ures determined under § 425.500 using the GPRO web interface established by CMS, to qualify on behalf of their eligible professionals for theCMS-1590-P 548

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 in order to receive a PQ RS incentive under the Shared Savings Program. For the years in whic h a PQRS incentive is available, if eligible professionals that participate in an ACO as ACO providers/supplie rs qualify for a PQRS incentive payment under the Medicare Shared Sa vings Program, the ACO participant TIN(s) under which those ACO providers/suppliers bill, will receive an incentive payment based on the allowed charges of those ACO providers/suppli ers. Under §425.504(a)(4) , ACO participant TINs and individual ACO providers /suppliers who are eligible prof essionals cannot earn a PQRS

incentive outside of the Medicare Shared Sa vings Program. The PQ RS incentive under the Medicare 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 services furnished during the calend ar year reporting period from January 1 through December 31, for years 2012 through 2014. As discussed in section III.G of this proposed rule, as required by section 1848(a)(8) of the Act , a payment adjustment will apply unde r the PQRS beginning in 2015. For eligible professionals who are not satisfactory reporte rs, the PFS amount for covered professional services furnished by the eligib le professional during 2015 shall be equal to 98.5 percent (and 98 percent for 2016 and each subsequent year) of th e fee schedule amount that would otherwise apply to such services. Therefore, consistent with our authority under section 1899(b)(3)(D) of the Act, we propose to amend §425.504 to inco rporate reporting requirements for the PQRSCMS-1590-P 549

payment adjustment under the Shared Savings Progr am for eligible profes sionals that are ACO providers/suppliers. We are proposing to incorporate requirements for 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 propose 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 of both the PQRS incentive under the Shared Savings Program and the PQRS payment adjustment under the Shared Savings Program. For purposes of the payment adjustment, we propose 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 propos e 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 profe ssionals must report on all measures

included in the GPRO data collection tool under the Shared Savings Program final

rule.

• Beneficiaries would be assigned to th e ACO using the methodology described in § 425.400. As a result, the GPRO tool w ould be populated based on a sample of the ACO-assigned beneficiary population. AC Os must to complete the tool for the first 411 consecutively ranked and assigne d beneficiaries in the order in whichCMS-1590-P 550

they appear in the group’s sample for each domain, measures set, or individual measure if a separate denominator is requi red 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 AC O must report 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). Consistent with the reporting requirements fo r the PQRS incentive unde r the Shared Savings Program, ACOs would only need to satisfact orily 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 Savi ngs Program quality performance measures for purposes of satisfactory reporting for the PQRS payment adjustment. However, the ACO would still be required to satisfy th e ACO quality performance standards for purposes of determining eligibility for shared savings , as described in §425.502. We believe that using the same quality measur es and the same criteria for satisfactory reporting, including the same assignment and sampling methodology, under the Shared Savings program for both the PQRS incentive and paymen t adjustment is appropriate. Aligning the satisfactory reporting requirements for the PQRS payment adjustment under the Shared Savings Program with the reporting requirements for pur poses of the PQRS incentive under the Shared Savings Program would enable eligible profe ssionals that participate in ACOs as ACO providers/suppliers to comply with these reporting requirements, without imposing any additional reporting burden. In addition, as noted above, the 22 GPRO measures that are reported for purposes of the PQ RS incentive under the Shared Sa vings Program must also beCMS-1590-P 551

reported for purposes of assessing ACOs’ qua lity performance under the Shared Savings Program and determining the percentage of shared savings that ACOs are eligible to receive. Under the Shared Savings Program regulations at §425.500(e)(3), ACOs are required to report on all of the quality measures established by CMS, and the fail ure to report on those quality measures accurately, completely, and timely ma y subject the ACO to termination or other sanctions. Thus, ACOs already have significant incentives to report the 22 GPRO measures completely and accurately. Furthermore, aligning the reporting requirements could help to encourage greater participation in the Shar ed Savings Program, by minimizing the reporting burden imposed upon ACOs and their participants. Although we propose to use the same timefra me 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 propose that the timing of the reporting period would differ for purposes of the PQRS payment adjustment. Specifically, we propos e that the reporting period for the payment adjustment would fall 2 years prior to when th e payment adjustment would be assessed. For example, under the Shar ed Savings Program, the reporting period for the 2015 payment adjustment would be from January 1, 2013 through December 31, 2013. It is necessary for us to use a reporti ng period that precedes the year in which the payment adjustment is applicable to avoid retroactiv e payments and the reprocessing of claims. In addition, it is not operationally feasible for us to use a full calenda r year reporting period that falls closer to the year in which the payment adjustment is applicable because we need sufficient time to determine if the requirements for satisfactory reporting have been met and to adjust our claims systems prior to the start of the applicable year. We note that the length and timing of the reporting period that we are proposing for the PQRS payment adjustment under the Shared Savings Program is consistent with the one used for the traditional PQRS (76 FR 73392).CMS-1590-P 552

We also note that this proposal results in overlapping reporting periods for both the PQRS incentive and payment adjustment. For example, 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 believe us ing the same reporting period for purposes of both the incentive and payment adjustment would result in less reporting burden, since one set of measures from one reporting period would be us ed for purposes of both the PQRS incentive and payment adjustment. We believe ACOs will perceive this as more efficient than requiring one set of measures reported during one timeframe for purposes of the PQRS in centive and another set during another timeframe for purposes of the payment adjustment. Therefore, we propose that, if an ACO satisfactorily reports the ACO GPRO web interface measures during the applicable repo rting period, its partic ipant TINs with ACO providers/suppliers who are elig ible professionals, would not be subject to the PQRS payment adjustment. If an ACO does not satisfactoril y report the ACO GPRO web interface measures during the applicable reporting pe riod, its participant TINs with ACO providers/suppliers who are eligible professionals, would be subject to the PQRS paymen t adjustment starting in 2015. 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 participate in PQRS under the Shared Savings Program. Finally, just as ACO providers/s uppliers that are eligible pr ofessionals with an ACO may only participate under th eir ACO participant TIN as a gr oup practice under the PQRS GPROCMS-1590-P 553

under the Shared Savings Program for purposes of receiving an incentive as both a group and as

an individual under the same TI N (76 FR 67903), we propose that ACO providers/suppliers that are eligible professionals within an ACO must participate under the ACO participant TIN as a group practice under the PQRS GP RO under the Shared Savings Program for purposes of the PQRS payment adjustment. Thus, ACO providers /suppliers who are eligib le professionals may not seek to avoid the payment adjustment by reporting either as an individual under the traditional PQRS or under th e 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. Using the earlier example, if an eligible profe ssional is an ACO provider/supplier and satisfactorily reports under the PQRS unde r the Shared Savings Program in 2013 but subsequently exits the Shared Savings Program a nd participates in PQRS individual reporting in 2014, the eligible professional would not be su bject to the payment adjustment in 2015. Similarly, a group practice that satisfactorily reports under the traditional PQRS GPRO in 2013 and becomes an ACO participant in 2014 would not be subject to the payment adjustment in 2015. We recognize that group practi ces and ACOs may reorganize a nd that individual providersCMS-1590-P 554

and groups of providers ma y move in and out of ACOs from y ear to year, so 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 changes. We believe it would be unfai r to assess the payment adjustment on an eligible professional on the basi s of switching reporting op tions, if the eligible professional had satisfactorily re ported during the appl icable reporting period. We invite public comment on our proposals for Shared Savings Program ACOs and the PQRS payment adjustment and on the alternative considered. Please note that, in this proposed rule, we also discuss a proposal amending requirements for ACO data to be publicly reported on Physicia n Compare in section III.G. of this proposed

rule.CMS-1590-P 555

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) of 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 theirCMS-1590-P 556

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 beneficiaries who used expanded chiropractic services to treat a

neuromusculoskeletal condition in the demonstration areas, with those of beneficiaries with 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 thisCMS-1590-P 557

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 29.4 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 theCMS-1590-P 558

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.CMS-1590-P 559

K. Physician Value-Based Payment Modifier and the Physician Feedback Reporting Program 1. Value-based Payment Modifier and Physic ian Feedback Reporting Program Overview of Proposals Section 1848(p) of the Act requires the Secr etary to "establish a payment modifier that provides for differential payment to a physicia n or a group of physicia ns" under the PFS "based upon the quality of care furnished compared to cost ... during a performance period." In addition, section 1848(p)(4)(B)(iii) of the Act re quires the Secretary to apply the payment modifier beginning January 1, 2015 to specific physicians and groups of physicians the Secretary determines appropriate. This section also requires the Secr etary to apply the value-based payment modifier for all physicians and groups of physicians (and allows the Secretary to apply the value-based payment modifier for eligible pr ofessionals as defined in section 1848(k)(3)(B) of the Act as the Secretary determines appropr iate) beginning not later than January 1, 2017. Section 1848(p)(4)(C) of the Act requires the value-based paymen t modifier to be implemented in a budget neutral (BN) manner. Section 1848(n) of the Act requires the S ecretary to provide c onfidential Physician Feedback reports to physicians that measure the resources involved in furnishing care to

Medicare beneficiaries. Secti on 1848(n)(1)(A)(iii) of the Act also authorizes us to include information on the quality of care furnished to Medicare beneficiaries by a physician or group of physicians in those reports. In developing our proposals for the value-base d payment modifier, we have reviewed our experience over the past 3 years in providing Phys ician Feedback reports to certain physicians and groups of physicians. The Physician Fee dback reports allow us to test different methodologies and to obtain stakeholder feedback th at can be used to further refine the reports and inform our policy proposals and recommenda tions. We have also linked the PhysicianCMS-1590-P 560

Feedback reports with the Physician Quality Re porting System (PQRS), by including the quality measures physicians and groups of physicians reported in the PQRS program in the 2010 Physician Feedback reports that we produced and disseminated in 2011 (to groups of physicians) and early 2012 (to individual physicians). In this proposed rule, we discuss our propos als to implement the value-based payment modifier (which will affect payments starti ng in 2015). These proposal s focus on creating value for Medicare fee-for-service (FFS) beneficiaries by focusing on prev ention and effective chronic disease care and by encouraging hi gh quality care for the most difficult cases. The proposals recognize that physician quality measurement is still evolving and that our methodologies are still developing. We designed our proposals to (1) provide groups of physicians with 25 or more eligible professionals an option that their value-based payment modifier be calculated using a quality-tiering approach; (2) focus our paymen t adjustment (both upward and downward) on those groups of physicians that are outliers, that is on those that are significantly different from the mean; and (3) align the value-based payment modifier with the PQRS and utilize Medicare

claims data in order to reduce administrative bu rden on groups of physicia ns. We believe that our proposals are adaptable to sma ller groups of physicians and physicians in solo practices that will be subject to the value-based payment m odifier starting in 2017 a nd we seek comment on the potential for our current proposals to be appl ied to all physicians and groups of physicians. We also encourage physicians and other stakehol ders to work with us to include additional quality measures (including additional outcome measures) that meaningfully measure the care they provide to Medicare beneficiaries. Our proposed scoring methodology for the va lue-based payment modifier would assess quality of care furnished compared to cost duri ng the performance period (which is 2013 for the first year) to calculate an adjustment to payments under the PFS during the payment adjustmentCMS-1590-P 561

period (which is 2015 for the first year). In light of our desire to align CMS quality improvement programs, this methodology relies, in part, on the data submitted on quality measures by groups of physicians through the PQRS . Quality measurement is necessary, but not sufficient, for quality improvement and a focus on value. 5 To balance our goals of beginning the implementation of the value-based payment modifier consistent with the legislative requirements and to give us and the physician community expe rience in its operation, we propose to separate all groups of physicians with 25 or more eligible professionals into tw o categories based on how they have chosen to participate in the PQRS. The first category includes those groups of physicians that have met the criteria for satisfactory reporting of data on PQRS quality m easures for the 2013 and 2014 incentives or the criteria for satisfactory reporting using the admi nistrative claims-based reporting mechanism, which is applicable to th e 2015 and 2016 PQRS payment adjustment. These groups of physicians will have fulfilled a key condition for qua lity improvement and a focus on value, that is, to measure quality by reporting data on quality measures that can be used to assess quality of care furnished. Thus, we propose initially to set the value-based payment modifier at 0.0 percent for these groups of physicians, meaning that the value-based payment modi fier would not affect their payments under the PFS. Within this category of satisfactory PQRS re porters, we propose to offer an option that their value-based payment modifier be calculated using a quality-tiering approach. This option would allow these groups of physicians to ear n an upward payment adjustment for high performance (high-quality tier and low-cost tier) performance, and to be at risk for a downward payment adjustment for poor performance (low-quali ty tier and high-cost tier). Because of the BN requirement and proposed limit on the downwar d adjustment noted below, we cannot specify

5 Mark R. Chassin, et al. “Accountability Measures – Using Measurement to Promote Quality Improvement,” N Eng. J. of Med. 2010; 363:683-688 (Aug. 2010), available at http://www.nejm.org/doi/full/10.1056/NEJMsb1002320.CMS-1590-P 562

the exact amount of the upward payment adjust ment for groups of physicians achieving high performance. We propose, however, that the maximum downward payment adjustment for these groups would be -1.0 percent for poor performance because we recognize that 2015 is the initial year for the value-based modifier and we wish to provide for a very modest adjustment for the initial years. We be lieve this methodology would encourage future improvement in terms of

better value for Medicare benefi ciaries without being overly burdensome to groups of physicians that requested to have their value-based paymen t modifier be calculated using the quality-tiering approach. The second category includes those groups of physicians with 25 or more eligible professionals that have not met the PQRS sa tisfactory reporting criteria identified above, including those groups of physicians that have de cided not to participat e in any PQRS reporting mechanism. Because we would not have quality measure performance rates on which to assess the quality of care furnished by these groups of physicians, we propose to set their value-based payment modifier at -1.0 percent as described in more detail in our proposal below. We note that this downward payment adjustment for the 2015 value-based payment modifier would be in addition to the -1.5 percent payment adjustment that is assessed under section 1848(a)(8) of the Act for failing to meet the satisfactory reporting criteria under PQRS. Th erefore, groups of physicians with 25 or more elig ible professionals that fail to meet the PQRS satisfactory reporting criteria would be s ubject to a downward adjustment s during 2015 of 1.5 percent for eligible professionals who fail to be satisfactor y reporters under the PQRS and 1.0 percent for the value-based payment modifier. Because the value-based payment m odifier provides upward payment adjustments for groups of physicians on the high-quality and lost-cost tiers, we encourage groups of physicians with 25 or more e ligible professionals to elect that their valuebased payment modifier be calculate d using the quality-tiering approach.CMS-1590-P 563

In this proposed rule, we (1) expand upon our vision of how we see the value-based payment modifier helping transf orm Medicare from a passive paye r to an active purchaser of higher quality, more efficient heal thcare; (2) propose to whom th e value-based payment modifier would apply starting in CY 2015 in ways that emphasize the va lue-based payment modifier’s focus on increasing quality measurement such that all physicians and groups of physicians would be subject to value-based paymen t modifier starting in CY 2017; (3) propose ways to align the value-based payment modifier with the quality measures and reporting re quirements established under the PQRS; (4) propose how we would score the value-based paymen t modifier and apply the BN requirement in ways that encourage qua lity reporting through the PQRS; and (5) describe how we have used and plan to continue to use the Physician Feedback reports to further inform physicians and groups of physicians about th eir quality of care and resource use. 2. Value-Based Payment Modifier Overview The value-based payment modifier is an important component in revamping how care and services are paid for under the PFS that has the potential to help tr ansform Medicare from a passive payer to an active purchas er of higher quality, more effici ent and effective healthcare. We recognize that although the qua lity of care furnished is high in many regards, this fact ignores “[h]ealth care today harm s too frequently and routinely fails to deliver its potential benefits” to patients. 6 Indeed, the Institute of Medicine has stated that the “health care system as currently structured does not, as a whol e, make the best use of its resources.” 7 Findings from the 2010 Physician Feedback reports confirm this stat ement: high value (high quality and low cost)

6 Institute of Medicine, “Crossing the Quality Chasm,” (2001 ) at 1; Elizabeth A. McGlynn, “The Case for Keeping Quality on the Health Reform Agenda,” prepared testimony before the Senate Committee on Finance (June 3, 2008), available at http://www.rand.org/content/dam/rand/ pubs/testimonies/2008/RAND_CT306.pdf 7 “Crossing the Quality Chasm” at 3.CMS-1590-P 564

can be achieved and there is substantial room for quality improvement and better value. 8 We believe that the value-based payment modifier can be used to incent ivize and reward high quality, efficiently furnished care by providing upward paymen t adjustments under the PFS to high performing physicians (and groups of physicians) and downward adjustments for low performing physicians (and groups of physicians). We recognize, however, that physicians are th e forefront of care delivery and that changes in payment policy can directly affect me dical care that physicians furnish to Medicare beneficiaries. Consistent with the National Qu ality Strategy, our aim is to promote preventive care and improve rather than impede the care that beneficiaries cu rrently receive, especially for the chronically ill and those with the most complicated cases. Thus, we seek to implement payment policies that complement and support “t he courage, hard work, and commitment of doctors, nurses, and others in he alth care” to improve the health care systems in which they

work. 9 We explained in the CY 2012 PFS proposed ru le that Medicare is beginning to implement value-based payment adjustments for other types of services, including inpatient hospital services (76 FR 42908). We have also developed plans to implement value-based purchasing for skilled nursing f acilities, home health services and ambulatory surgical center services. In implementing value-based purchasin g initiatives generally, we seek to 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

8 CMS, “Analysis of 2010 Quality and Resource Use Re ports for Medical Practice Groups” (2012), available at http://www.cms.gov/Medicare/ Medicare-Fee-for-ServicePayment/PhysicianFeedbackProgram/Download s/QRURs_for_Medical_P ractice_Groups.pdf 9 “Crossing the Quality Chasm” at 4.CMS-1590-P 565

changes in patient functional status. Across all pr ograms, we seek to 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 seek to evolve a focused core set of measures appropriate to each spec ific 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.

● 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 proc esses to deliver higher qu ality and more efficientCMS-1590-P 566

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, 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. To start to implement this long-term vision of the value-based paym ent modifier, we have

undertaken numerous activi ties in the past year to inform our proposals in this rule. We have obtained stakeholder input about the content (including the complete ness of the quality measures) and methodologies we have used in the Physician Feedb ack reports, as well as input on how the private sector has used physician pa y-for-performance programs. In particular, we conducted five national provider calls about me thodologies we have used in the Physician Feedback reports and similar private sector initiatives. 10 We also held (and continue to hold)

10 See CMS, Physician Feedback Program Te leconferences and Ev ents, available at http://www.cms.gov/Medicare/Medi care-Fee-for-Service-Payment/P hysicianFeedbackProgram/CMSTeleconferences- and-Events.htmlCMS-1590-P 567

numerous sessions with Physician Feedback repo rt recipients (both at the individual and group practice level) to obtain additional feedback to improve the methodologies used in the reports. These recent activities complement the wo rk we have undertaken to implement the statutory objectives to improve quality of care furnished by physicians and groups of physicians to Medicare beneficiaries. For example, th e Congress required the Physician Group Practice (PGP) Demonstration, which we implemented in 2005. The PGP Demonstration was the first pay-for-performance initiative under the Medicar e program that involved a shared savings

model. The demonstration created incentives for physician groups to coordi nate the overall care

furnished to Medicare beneficiaries and rewa rded them for improving the quality and cost efficiency of health care services. By the fi fth year of the demons tration, all 10 of the participating physician groups achieved quality be nchmark performance on at least 30 of the 32 measures, and seven of the groups achieved benchmark performance on all 32 performance measures. The PGP quality reporting tool a nd its methodology also became the basis for the Group Practice Reporting Option (GPRO) under the PQRS. In 2003, we implemented the Medicare Care Management Performance (MCMP) demonstration project. The demonstration showed that small and solo physician practices are willing to participate in quality measurement and reporting. Almost 700 physician practices of various sizes used a GPRO-like reporting tool to report data on 23 quality measures. In 2006, Congress established what is now known as the Physician Quality Reporting System (PQRS), which is a voluntary quality repo rting program that, as subsequently amended, provides a combination of incentive payments and payment adjustments to eligible professionals (including group practices) based on whether they satisfactorily re port data on quality measures for covered professional services furnished to Medicare Part B FFS be neficiaries. In 2010,CMS-1590-P 568

268,968 eligible professionals 11 participated in PQRS in addition to those physicians participating in quality reporting through the PQRS GPRO option. Recently, we provided physicians and groups of physicians with c onfidential Physician Feedback reports that provide them with compar ative performance data on quality of care they furnish compared to costs. Results from the most recent group practi ce reports show little correlation between quality of care furnished and co st for the 35 participating group practices to whom we provided reports--high quality can be as sociated with high or lo w cost (and vice versa) (see Physician Feedback Program discussion be low). Moreover, overall results from the individual Physician Feedback reports based on 2 010 data show that clinical care is highly fragmented and there is substantial room for im provement in the quality of care furnished to

Medicare fee for service beneficiaries.

Based on what we have learned from the aforementioned demonstration projects, the results from the PQRS and the confidential Phys ician Feedback reports, and our outreach on the national provider calls on private sector progra ms, we believe the value-based payment modifier and the Physician Feedback re ports can be used to incenti vize and reward high quality, efficiently furnished care by providing upwar d payment adjustments under the PFS to high performing physicians and downward adjustments fo r low performing physicians. To do so, we believe the following specific principles should 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

11 Eligible professionals include physicians and non-physicia ns such as physician assistants and nurse practitioners.CMS-1590-P 569

measures for the value-based payment modifier should consistently re flect 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. In the proposals described later in this section, we propose to expand the quality measures for the value-base d payment modifier. We also encourage physicians to work with us to include additional quality measures (including outcome measures) that meaningfully measure the care they furnish to Medicare beneficiaries.

● A focus on physician choice . Physicians should be able to choose the level at which their performance will be assessed reflect ing 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 prog ram participation. In the proposals described later in this section, we propose to rely on the quality measure data collected through the PQRS Group Practice Reporting Option (GPRO) and Medi care EHR Incentive Program to obtain most of the performance data for the value-based payment modifier.

● A focus on shared accountability . CMS has a role in fostering high value care for individual patients, but also focusing on how that patient inte racts with the health care system generally. We believe that the value-based paym ent modifier can facilita te shared accountability by assessing performance at the practice group le vel and by focusing on the total costs of care, not just the costs of care furnishe d by an individual physician. In the proposals desc ribed later in this section, we propose to use performance on seve ral outcome measures th at we will calculate for physicians reporting measures at the group level that encourage them to seek innovative waysCMS-1590-P 570

to furnish high-quality, patient-centered, and effi cient care to the Medicare FFS patients they

treat. We also seek to start a discussion on how best to incorporate i ndividual, hospital-based, and community-based quality and cost measures as a component of the value-based payment modifier so that we align quality measurement st rategies across providers and settings of care.

● 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 se rve this purpose. In the proposals described later in this section, we propose ways to provide additi onal feedback to physicians and groups of physicians through the Physician Feedback reports.

● 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. In the proposals described late r in this section, we pr opose to allow groups of physicians with 25 or more eligib le professionals to elect how th e value-based payment modifier would be applied to them under the PFS star ting in 2015. We also propose a scoring methodology that can identify outliers (both high and low performers) and is flexible to accommodate these future goals.CMS-1590-P 571

We seek comment on these principles as guides to our implementation of the valuebased payment modifier. 3. Proposals for the Value-Based Payment Modifier In the following sections, we describe our proposals for each co mponent of the valuebased payment modifier. These components in clude: the quality measure reporting methods; the quality and cost measures; the attributi on methodology; the payment adjustment amount; the scoring methodology; and the review and inquiry process. Following the discussion of these components, we summarize how the components w ould work together for a group of physicians with 25 or more eligible profe ssionals that submits data on qua lity measures using the PQRS GPRO web-interface and requests th at their value-based payment modifier be calculated using the quality-tiering approach. a. Proposed 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 fu rnished beginning on January 1, 2015, for specific physicians and groups of physicians the Secret ary determines appropr iate, and beginning not later than January 1, 2017 for a ll physicians and groups of physicians. For purposes of this proposed rule, physicians are defined in section 1861(r) of the Act to include doctors of medicine or osteopathy, doctors of dental surgery or dental medicine, doctors of podiatric medicine, doctors of optometry, and chiropractors. We propose to initially include all groups of physicians with 25 or more eligible professionals in the value-based payment modifier . For purposes of establishing group size, we propose to use the definition of an eligible prof essional as specified in section 1848(k)(3)(B) of the Act. This section defines an eligible prof essional as any of the following: (1) a physician; (2) a practitioner described in section 1842(b)(18) (C) of the Act; (3) a phy sical or occupationalCMS-1590-P 572

therapist or a quality speech-language pathologist; or (4) a qualified audiologist. In addition, we propose to define a group of physicians as “a sing le Tax Identification Nu mber (TIN) with 25 or more eligible professionals, as identified by their individual Nati onal Provider Identifier (NPI), who have reassigned their Medica re billing rights to the TIN. ” We chose these groups of physicians in order to align with the repor ting requirements for group practices and the definitions used in the PQRS. We also propose to assess whether a group of physicians has 25 or more eligible professionals at th e time the group of physicians is selected to participate under the PQRS GPRO. We propose to apply the value-based payment modifier to the Medicare paid amounts for

the items and services billed under the PFS at the TIN level so that bene ficiary cost-sharing or coinsurance would not be affected. We also pr opose to apply the value-based payment modifier to the items and services billed by eligible pr ofessionals who are physicians under the TIN, not to other eligible professionals that also may bill under the TIN. In addition, application of th e value-based payment modifier at the TIN level means that we would not “track” or “carry” a physician’s pe rformance from one TIN to another TIN. In other words, if a physician changes groups from TIN A in the performance period (2013) to TIN B in the payment adjustment period (2015), we would apply TIN B’s value-based payment modifier to the physician’s payments for items and services billed under TIN B during 2015. We are making this proposal for two reasons. Firs t, payment at the group practice (TIN level) reflects the view that the group in which a physician practices matters. Second, we believe 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 physician billing under the TIN receive th e same value-based payment modifier. We seek comment on these proposals.CMS-1590-P 573

It is critical to note that ou r proposals would allow groups of physicians with 25 or more eligible professionals to decide how the value-ba sed payment modifier would be applied to their PFS payments. In light of our desire to a lign CMS quality improvement programs, this methodology relies, in part, on the data submitte d on quality measures by groups of physicians through the PQRS. Quality measurement is necessary, but not sufficient, for quality improvement and a focus on value. We propose to separate all groups of physicians with 25 or more eligible professionals into two categories ba sed on how they have chos en to participate in the PQRS. The first category includes those groups of physicians with 25 or more eligible professionals that have met th e proposed criteria for satisfact ory reporting of data on PQRS quality measures for the 2013 and 2014 incentive or the proposed criteria for satisfactory reporting using the administrative claims-based re porting mechanism, which is applicable to the 2015 and 2016 PQRS payment adjustment. These gr oups of physicians will have fulfilled a key condition for quality improvement and a focus on value, that is, to measure quality by submitting and/or having data on quality meas ures that can then be used to assess quality of care furnished. We propose initially to set the value-based paym ent modifier at 0.0 percent for these groups of physicians, meaning that the value-based paymen t modifier would not affect their payments under the PFS. We point out that in order fo r a group of physicians to meet the satisfactory reporting criteria, the group of physicians must fi rst self-nominate as a group as described above in Section III.G.1.b.2 of this pr oposed rule regarding the PQRS. Within this category of satisfactory PQRS re porters, we propose to offer an option that their value-based payment modifier be calculate d using the quality-tiering approach described below in subsection (h) Proposed Value-Based Payment Modifier Scoring Methodology. Under these proposals, groups of physicians could ea rn an upward payment adjustment for highCMS-1590-P 574

performance (high-quality tier compared to low-co st tier) performance, and be at risk for a downward payment adjustment for poor performan ce (low-quality tier co mpared to high-cost tier). We seek comment, however, on whether to calculate the value-base d payment modifier for all groups of physicians that are satisfactory PQ RS reporters using the quality-tiering approach described in subsection (h) below, rather than providing an option for such groups of physicians to request that we do so. The second category includes those groups of physicians with 25 or more eligible professionals that have not met the PQRS satisf actory reporting criteria id entified above. Under our proposal, a group of physicians could fail to meet the PQRS satisfact ory reporting criteria because the group of physician decided not to pa rticipate in any PQRS reporting mechanism or because the group attempted to submit data, but failed to meet the criteria to become a satisfactory reporter (e.g., did not report data appropriately on the requisite number of beneficiaries or measures). Because we woul d not have quality measure performance rates on which to assess the quality of care furnished by these groups, we propose to set their value-based payment modifier at -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. We believe this approach is a reasonabl e way to phase in the value-based payment modifier because groups of physicians have demons trated their ability to submit data on quality measures at the group level using the PQRS GPRO since 2011. And for 2012, we revised the eligibility criteria fo r the PQRS GPRO to include groups with at least 25 eligible professionals. Thus, we believe that these gr oups of physicians have had sufficient opportunity to make an informed decision about submitting data on quality measures that also could be used in the value-based payment modifier starting in 2015. Moreover, section 1848(p)(5) of the Act requires us to, as appropriate, ap ply the value-CMS-1590-P 575

based payment modifier “in a manner that promot es systems-based care.” In this context, systems-based care is the processes and workflow s that (1) make effective use of information technologies, (2) develop effective teams, (3) c oordinate care across pati ent conditions, services, and settings over time, and (4) incorporate performance and outcome measurements for improvement and accountability. 12 We believe that groups of physicians have the ability and the resources to redesign such processes and wo rkflows to achieve these objectives and furnish high-quality and cost-effective clinical care. Starting in 2017, we would a pply the value-based payment modifier to all physicians and groups of physicians as requ ired by the statute. We seek comment on whether we should offer individual physicians and gr oups of physicians with fewer than 25 eligible professionals an option that their value-based payment modifier be calculated using a quality-tiering approach starting in 2015. If we did so, we could calculate a value-based payment modifier for groups of physicians with as few as two eligible prof essionals and apply the value-based payment

modifier at the TIN level in the manner describe d in these proposals fo r groups of 25 or more eligible professionals. Likewise, we seek comm ent on how to adapt our proposals to calculate a value-based payment modifier at the TIN level for physicians in solo practices (TINs comprised of one NPI).

We also seek comment on whether we shoul d develop a value-based payment modifier option for hospital-based physicians to elect to be assessed based on the performance of the hospital at which they are based. In particular, hospital performance could be assessed using the measure rates the hospitals report on the quality measures in the Inpatient Quality Reporting (IQR) and the Outpatient Quality Reporting (OQR ) programs. If so, we seek comment on which

12 Johnson JK, Miller SH, Horowitz SD. Systems-based practice: Improving the safety and quality of patient care by recognizing and improving the systems in which we work. In: Henriksen K, Battles JB, Keyes MA, Grady ML, editors. Advances in Patient Safety: New Directions an d Alternative Approaches, Vol 2: Culture and Redesign. AHRQ Publication No. 08-0034-2. Rockville, MD: Agency for Healthcare Research and Quality; August 2008. p. 321-330.CMS-1590-P 576

IQR and OQR measures (and the applicable reporti ng period) would be appr opriate to include in such an option and a way to identify and verify whether physicians are hospital-based. The IQR

measures can be found at http://qualitynet.org/dcs/C ontentServer?c=Page&pagename=QnetPublic%2FPage%2FQnetTier2

&cid=1141662756099 and the OQR measures can be found at http://qualitynet.org/dcs/C ontentServer?c=Page&pagename=QnetPublic%2FPage%2FQnetTier2

&cid=1196289981244

. In addition, we seek comment on how best to ascertain whether a group of physicians with 25 or more eligible prof essionals requests the option th at their value-based payment modifier be calculated using a qua lity-tiering approach. We seek to establish a system that reduces administrative burden on physicians, enab les these groups of physicians to indicate how they plan to submit data on quality measures th rough the PQRS, and is easy to administer. We could, for example, build off of the self-nomina tion process that we have proposed for groups of physicians to participate in the PQRS GPRO. As discussed in Section III.G.1.b.2 of this proposed rule regarding the PQRS, we anticipate that we will have the ab ility to collect selfnomination statements via the web in 2013. As proposed above, these self-nomination statements would be submitted by January 31, 2013 for the 2013 performance period. In the event that the web-based functionality is una ble to accept self-nomination statements for 2013, we have proposed that groups of physicians subm it a self-nomination statement via a letter (in a prescribed format) to CMS in a timely manner. We also could establish a separate web-base d registration system that permits groups of physicians to , throughout calendar year 2013, reque st that their value-ba sed payment modifier be calculated using the quality-t iering approach (rather than submit a self-nomination statement by January 31, 2013 as proposed in the PQRS se lf-nomination process). Another approachCMS-1590-P 577

would be to require that groups of physicians submit a letter (in a prescribed format) to CMS in a timely manner. We seek comment on these approaches. We propose not to offer groups of physicians wi th 25 or more eligible professionals that are participating in the Medicare Shared Savings Program or ar e associated with the Pioneer ACO program, assuming they meet the PQRS satisf actory reporting criteria , the option that their value-based payment modifier be calculated using the quality-t iering approach. As of April 2012, 27 ACOs are participating in the Shared Sa vings Program, and 32 ACOs are participating in the Pioneer ACO program. We anticipate more ACOs will enter the Medicare Shared Savings Program beginning July 1, 2012, and on January 1 st annually thereafter. Shared Savings Program ACOs will be in a “pay for re porting” mode in 2013, while Pioneer ACOs will be in a “pay for performance” mode in 2013. We make this proposal because we are mi ndful that the physicians and groups of physicians that are, or will be, participating in the Shared Savings Program and the Pioneer ACO program have made sizable investments to redesign care processes based on the incentives created by these programs. Indeed, these organizations have committed to reporting on a broader set of quality measures than we are prop osing for the value-based payment modifier to demonstrate the quality of care their benefi ciaries are receiving. We do not wish to unintentionally disturb these invest ments. Therefore, we seek co mment on ways to structure the value-based payment modifier starting in 2017 so it does not create incenti ves that conflict with the goals of the Shared Savings Program and th e Pioneer ACO program. Alternatively, we seek comment on whether we should permit groups of phys icians that are participating in these two programs the option that their value-based paym ent modifier be calculated using a qualitytiering approach and applied to their payments under the PFS starting in 2015. We note that the value-based payment modi fier is applicable only to payment forCMS-1590-P 578

physicians’ services under the PFS. The valu e-based payment modifier does not apply to services that physicians furnish in Rural Hea lth Clinics (RHCs), Fede rally Qualified Health Centers (FQHCs), and Critical Access Hosp itals (CAHs) billing under method II (but not method I or the standard method), because they ar e not considered as being paid under the PFS. b. Proposed 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-based payment modifier that we would apply to item s and services for which payment is made under the PFS during CY 2015. Likewise, we propose that performance in CY 2014 be used to calculate the value-based payment modifier that is applied to items and services for which payment is made under the PFS during CY 2016. As we explained previously in the CY 2012 PFS final rule with comment period (76 FR 73435), we explored different options to close th e gap between the performance period (that is, 2013) and the payment adjustment period (that is, 2015), but 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 continue to explore ways to provide more timely feedback to physicians and to narrow the gap between the performance period and the payment adjustment period and seek comment on practical alternatives that we could implement to do so. We seek comment on ourCMS-1590-P 579

proposal to use CY 2014 as the performance peri od for the 2016 value-based payment modifier. c. Proposed Quality Measures In this section we discuss our proposals to align quality measure reporting for the valuebased payment modifier with PQRS reporting me thods, to expand the range of quality measures that we will use for the value-based payment methodology, and to start a discussion on how to assess community based quality of care. (1) Alignment of Quality Reporting Options with PQRS Satisfactory Reporting Criteria As discussed above, we propose to categori ze groups of physicians with 25 or more eligible professionals into two categories depending upon whether they have met the PQRS satisfactory reporting criteria es tablished above for the value-ba sed payment modifier. We note that under those proposed criteria for satisfact ory reporting, groups of 25 or more eligible professionals would be able to submit data on quality measures using one of following proposed PQRS reporting mechanisms: PQRS GPRO using th e web-interface, claims, registries, or EHRs; or PQRS administrative claims-based option. Th ese reporting mechanisms are discussed above in Section III.G of this proposed rule (Physicia n Payment, Efficiency, and Quality Improvement – Physician Quality Reporting System). The satis factory reporting criteria for the PQRS GPRO reporting mechanisms are described in Tables 27 and 28. The satisfactory reporting criteria for the PQRS administrative claims-based reporting op tion is described in Section III.G. (“Proposed Criteria for Satisfactory Repor ting for the 2015 and 2016 Payment Adjustments for Eligible Professionals and Group Practices using th e Administrative Claims-based Reporting Mechanism.”) We propose to rely on these propos ed criteria for satisfact ory reporting in order to categorize groups of physicians for purposes of the value-based payment modifier. For those groups of physicians that have me t the PQRS satisfactory reporting criteria and request that their value-based pa yment modifier be calculated us ing a quality-tiering approach,CMS-1590-P 580

we propose to use the performance rates on the qu ality measures reported through any of these reporting mechanisms. We seek comment on this proposal. We are c oncerned, however, that some groups of physicians may attempt to subm it data on PQRS quality measures using one of the GPRO reporting mechanisms (web-interface, clai ms, registries, or EHRs) and fail to meet the criteria for satisfactory reporting and thus be categorized as non- PQRS reporters (and be subject to the -1.0 percent downward adjustment). To a ddress this issue, we seek comment on whether to assess performance on the measures included in the PQRS administrative claims-based reporting option as a default if a group of physicians attempts to participate in on e of the PQRS GPRO reporting mechanisms and does not meet the PQRS criteria for satisfactory reporting. In addition, we seek comment on which PQRS reporting mechanisms we should offer to individual physicians if we were to apply the value-based payment modifier applied to their payments under the PFS starting in 2015 or 2016. Tables 25 and 26 describe the proposed PQRS reporting options available to individual physicians for the 2013 and 2014 PQRS incentives. (2) Quality Measure Alignment with the Physician Quality Reporting System

In the CY 2012 PFS final rule with comme nt period (76 FR 73432) , we finalized, for physicians practicing in groups, all measures in the GPRO of PQRS for 2012. We also stated that we expected to update these measures fo r the initial performance year (CY 2013) of the value-based payment modifier based on the meas ures finalized in subsequent rulemaking under PQRS. (76 FR 73427 through 73432). We propose to include all individu al measures in the PQRS GPRO web-interface, claims, registries , and EHR reporting mechanisms for 2013 and beyond for the value-based payment modifier. Thes e quality measures are included in Tables 30 and 32. We seek comment on this proposal. We also seek comment on the quality meas ures that we should propose for individual physicians if we were to provide individual physicia ns the ability to elect to have the value-basedCMS-1590-P 581

payment modifier apply to their payments under the PFS starting in 2015 or 2016. In the CY 2012 PFS final rule with comment period, we finaliz ed for individual physici ans, the PQRS core

set of measures for CY 2012 and the core set of measures, alternate core, and additional measures in the Medicare EHR Incentive Progra m for 2012. We seek comment on which PQRS measures for 2013 and beyond to include in calculat ing the value-based payment modifier at the individual level. Table 32 lists the PQRS measures we are proposing for reporting through PQRS for 2013 and beyond. We belie ve incorporating all the PQRS measures provides a broad set of quality measures from which physicians ca n choose how best to assess their performance. We seek comment on these issues and the above proposals. (3) Administrative Claims Option under PQRS Under the PQRS, we propose to provide an option for physicians and groups of physicians to select an administrative claims-b ased reporting option for purposes of the PQRS payment adjustment for 2015 and 2016 only. We discuss two issues surrounding this proposed administrative claims-based reporting option as it relates to the value-based payment modifier: (1) the level at which to assess the administrative claims-based measures (individual or group), and (2) the scope of quality measures that will be assessed using administrative claims. (a.) Level of Performance Assessment We can either assess performance at the indivi dual physician level, as we did in the 2010 individual Physician Feedback reports, or at the group practice level a nd apply the performance rate to the physicians that are part of that group. Measurement a nd assessment at the individual level (as identified by a National Provider Id entification number (NPI )) provides actionable information for improvement for physicians and can incentivize physician accountability for quality of care and cost. Despite these benef its, assessments of individual physicians using administrative claims-based measures may resu lt in insufficient numbers of cases at theCMS-1590-P 582

individual level to develop stat istically reliable performance rate s for each measure. Moreover, because physician performance would affect paym ent, we believe performance rates should be statistically reliable. Assessment of physician performance at the gr oup practice level (as identified by a single Taxpayer Identification Number (TIN)) reflects the view that the group in which a physician practices matters. 13 Group practice assessments will allow fo r a larger number of cases to assess performance scores and a larger number of outcome measures th an assessments solely at the individual level. The larger number of cases also means the performance scores will be more statistically reliable on which to modify payment. It also allows us to calculate more quality measures in more domains of the National Qual ity Strategy. For these reasons, for purposes of the value-based payment modifier, we propose to assess performance rates for the measures in the PQRS administrative claims-based reporting op tion at the TIN level and apply the calculated performance score and the resulting value-based payment modifier to all physicians that bill under that TIN during the payment adjustment period. We seek comment on this proposal. (b.) Quality Measures In the CY 2010 individual Physician Feedb ack reports, which we distributed to over 23,000 physicians in Iowa, Kansas, Missouri, and Nebraska in March 2012, we provided performance rates on 28 administrative claims-b ased measures. These measures focused on clinical care of prevalent and chronic diseases among Medicare beneficiaries and medication management measures and were assessed at th e individual physician le vel (that is, NPI). Twenty-seven of the 28 measures were endo rsed by the National Quality Forum and the remaining measure was developed and is maintained by the National Committee for Quality

13 See e.g., Johnson JK, Miller SH, Horowitz SD. Systems- based practice: Improving the safety and quality of patient care by recognizing and improving the systems in which we work. In: Henriksen K, Battles JB, Keyes MA, Grady ML, editors. Advances in Patient Safety: New Directions and Alternative Approaches, Vol 2: Culture and Redesign. AHRQ Publication No. 08-0034-2. Rockville, MD: Agency for Healthcare Research and Quality; August 2008. p. 321-330.CMS-1590-P 583

Assurance (NCQA). Specifications for all 28 ad ministrative claims-based measures can be

found at https://www.cms.gov/physicianfeedbackprogram

. We propose to include, for purposes of assessing performance for the PQRS administrative claims-based reporting option, 15 of these measures, which are indicated in Table

64. We have selected these 15 measures because they are clinically meaningful, focus on highly prevalent conditions among beneficiaries, have th e potential to different iate physicians, and are reliable. Most of the proposed measures do not re ly on the use of Part D drug data that we do not

have for all Medicare FFS beneficiaries. We al so note that these proposed measures are similar to the measures adopted in several private sector programs. 14 We also seek comment, however, on whether to include any of the remaining 13 m easures that we have not proposed, but included in the Physician Feedback Reports. Thes e measures are listed in Table 65. TABLE 64: Proposed Measures for the Admi nistrative Claims Option for 2015 and 2016 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

0021 Annual Monitoring for Beneficiar ies on Persistent Medications Percentage of patients 18 years of age and olde r who received at least 180 treatment days of ambulatory medication therapy for a select ther apeutic agent during the measurement year and at least one therapeutic monito ring event for the therapeutic ag ent in the measurement year. NCQA Patient Safety

0555 Lack of Monthly INR Monitoring for Beneficiaries on Warfarin Average percentage of 40-day inte rvals in which 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

0549 Pharmacotherapy Management of COPD Exacerbation Percentage of chronic obstructive pulmonary disease (COPD) exacerbations for patients 40 years of age and older who had an acute inpatie nt discharge or ED encounter between January 1–November 30 of the measurement year a nd were dispensed a ppropriate medications 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 Care

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 six NCQA Clinical Care

14 Zirui Song, et al, “Health Care Spending and Quality in Year 1 of the Alternative Quality Contract,” New England Journal of Medicine, 365:10 (Sept. 2011).CMS-1590-P 584

NQF Number Measure Title Measure Steward Domain of Care months after the date of fracture. 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 ey e care professional in the year prior to themeasurement 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 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 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 65: Remaining Measures Not Proposed for the Administrative Claims Option

NQF Number Measure Title Measure Steward Domain of Care

Not NQF Endorsed Potentially Harmful Drug-Disease Interactions in the Elderly The percentage of Medicare members 65 years of age and older who have evidence of an underlying disease, condition or health con cern and who were dispensed an ambulatory prescription for a contraindicated medication, concurrent with or after the diagnosis

. NCQA Patient Safety

0071 Acute Myocardial Infarction (AMI ): Persistence of Beta-Blocker Treatment After a Heart Attack Percentage of patients age 18 years and ol der during the measurement year who were hospitalized and discharged alive with a diagnos is of acute myocardial infarction (AMI) and who received persistent beta-blocker tr eatment for six months after discharge NCQA Clinical Care

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 w ho 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

0556 INR for Beneficiaries Taking Warfar in and Interacting Anti-Infective Medications Percentage of episodes with an INR test performe d 3 to 7 days after a ne wly-started interacting anti-infective medication for Part D beneficiaries receiving warfarin CMS Patient Safety

0568 Appropriate Follow-Up for Patients with HIV Percentage of patients diagnosed with HIV w ho received a CD4 count and an HIV RNA level laboratory test in the 6 months following diagnosis Health Benchmarks Clinical Care

0623 Breast Cancer – Cancer Surveillance Percentage of female patient s 18 and older with breast ca ncer who had breast cancer surveillance in the past 12 months Active Health Management Clinical CareCMS-1590-P 585

NQF Number Measure Title Measure Steward Domain of Care

0625 Prostate Cancer – Cancer Surveillance Percentage of males with prostate cancer that have had their PSA monitored in the past 12 months Active Health Management Clinical Care

0054 Arthritis: Disease Modifying Antirh eumatic Drug (DMARD) Therapy in Rheumatoid Arthritis Percentage of patients 18 years a nd older, diagnosed with rheumato id arthritis who have had at least one ambulatory prescription dispensed for a DMARD NCQA Clinical Care

0581 Deep Vein Thrombosis Antico agulation At Least 3 Months Percentage of patients diagnosed with a lower ex tremity DVT more than 3 months prior to the end of the measurement year (who do not have c ontraindications to warfarin therapy and who do not have an IVC filter in the 90 days after th e onset of PE) who had at least 3 months of anticoagulation after the event or patients showing compliance with anticoagulation therapy as indicated by a Home PT Monitoring device or mu ltiple instances of prothrombin time testing over the 3-month period Resolution Health Clinical Care

0593 Pulmonary Embolism Anticoagulation At Least 3 Months Percentage of patients diagnosed with a PE mo re than 3 months prior to the end of the measurement year (who do not have contraindicati ons to warfarin therapy and who do not have an IVC filter in the 90 days afte r the onset of PE) who had at least 3 months of anticoagulation after the event or patients showing compliance w ith anticoagulation therapy as indicated by a Home PT Monitoring device or multiple instances of prothrombin time testing over the 3-month period Resolution Health Clinical Care

0614 Steroid Use – Osteoporosis Screening Percentage of patients, 18 and ol der, who have been on chronic st eroids for at least 180 days in the past 9 months and who had a bone dens ity evaluation or osteoporosis treatment Active Health Management Clinical Care

0567 Appropriate Work-Up Prior To En dometrial Ablation Procedure Percentage of women who had an endometrial ablation procedure during the measurement year who received endometrial sampling or hysteros copy with biopsy during the previous year Active Health Management Clinical Care

0584 Hepatitis C: Viral Load Test Percentage of patients 18 years or older w ith Hepatitis C (HCV) who began HCV antiviral therapy during the measurement year and had HC V Viral Load testing prior to initiation of antiviral therapy Resolution Health Clinical Care

(4) Outcome Measures for Groups of Physicians

We finalized in the CY 2012 PFS final rule (76 FR 73432) for physicians practicing in groups to include the rates of potentially preventable hospital admissions for two ambulatory care sensitive conditions (ACSCs) at the group pr actice level: heart failure; and chronic obstructive pulmonary disease. We also noted that several commenters to the CY 2012 proposed PFS rule expressed support for using outcome measures that assess the rate of potentially preventable hospital admissions including the Consumer-Purchaser Disclosure Project, a group of large purchasers of health care services. We believe it is appropriate to focus on potentially preventable hospital admissions because, as ou r 2010 Physician Feedback reports have shown, hospital inpatient, outpatient, and emergency de partment costs account for over 50 percent of total per capita costs. Thus, we propose to include four outcome measures in the value-basedCMS-1590-P 586

payment modifier for all groups of physicians wi th 25 or more eligible professionals. These

outcome measures are discussed below. It is im portant to note that we propose to calculate these measures for groups of physicians with 25 or more eligible prof essionals regardless of which reporting mechanisms the groups of physicians choose to report quality data: PQRS GPRO using the web-interface, claims, registries, or EHRs; or the PQRS administrative claims-based reporting option. Currently the Physician Fee dback reports that we provide to group practices include potentially preventable hospital admission measures for three chronic conditions: heart disease, chronic pulmonary obstructive disease, and diabetes (a composite measure including uncontrolled diabetes, short term diabetes compli cations, long term diabetes complications and lower extremity amputation for diabetes). In addition, the Physician Fe edback reports provide potentially preventable hospital admission measur es for three acute cond itions: dehydration; urinary tract infection; and bacter ial pneumonia. Specifi cations for all six of these measures can

be found at http://www.qualityindicators.ahr q.gov/Modules/PQI_TechSpec.aspx

. However, given the potential that any gr oup of physicians may have relatively few potentially preventable hospital admissions for a given condition, we propose to create for the value-based payment modifier two composites from these measures: an acute condition composite; and a chronic care composite. Compos iting measures is a well -established technique in quality measurement to increase reliability when the number of cases is small because it combines individual measures into one compos ite measure. Additionally, presenters on the National Provider Calls CMS held on February 29 and March 14 entitled “Physician ValueBased Payment Modifier Program: Experien ce from Private SectorPhysician Pay-forPerformance Programs” specifically recommended this approach for the value-based payment modifier. (Transcripts and slides from these presentations are available atCMS-1590-P 587

http://www.cms.gov/physicianfeedbackprogram .) We propose that the acute condition com posite combine the rates of potentially preventable hospital admission for dehydration, urinary tr act infection, and b acterial pneumonia. We propose that the chronic care composite combine the rates of potentially preventable hospital admissions for diabetes, heart failure, and chr onic obstructive pulmonary disease. We believe group practices will be incentivi zed to prevent these types of hospital admissions, which will improve patient care and re duce per capita costs. We also propose to use two other quality measures to assess care coordination at the group level that we currently use in other CM S physician quality programs: the all-cause hospital readmission measure used in the Medicare Shared Savings Program (described on the CMS Website at http://www.cms.gov/Medicare/ Medicare-Fee-for-ServicePayment/sharedsavingsprogram/D ownloads/ACO_QualityMeasures.pdf) and the 30-day postdischarge visit measure used in the PGP Transition Dem onstration (described athttps://www.cms.gov/Medicare/DemonstrationProjects/DemoProjectsEvalRpts/downloads// PGP_Transition_Quality_Specs_Report.pdf ). We believe that the all-cause hosp ital readmission measure provides a strong incentive for groups to focus on reducing hospital readmissions. In a ddition, the 30-day post-discharge visit measure helps incentivize physicians to engage in more ef fective care coordinatio n. Recent literature cites a study in which there was no visit to a physician's office between the time of discharge and rehospitalization for 50 percent of patients w ho were rehospitalized within 30 days after a medical discharge to the community. 15 Based on input and comments from stakeholders, including other payers, we believe that su ch follow up visits can reduce unnecessary rehospitalizations. These four m easures are summarized in Table 66.

TABLE 66: Four Outcome Measures for the Va lue-Based Payment Modifier for Groups of Physicians NQF Numbe r Measure Title Measur e Steward Domain of Care

N/A 1. Composite of Acute Prev ention Quality Indicators N/A Care Coordination 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 dehydration per 100,000 population. AHRQ N/A 2. Composite of Chronic Prevention Quality Indicators N/A Care Coordination Diabetes Composite 0638 Uncontrolled diabetes The number of discharges for uncont rolled diabetes per 100,000 population AHRQ

15 N Engl J Med 2009; 360:1418-1428CMS-1590-P 588

Age 18 Years and Older in a one year time period

. 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-te rm 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 lowe r-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 Coordination N/A 4. 30 Day Post Discharge Visit 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 Coordination

We also note that we are making plans to seek National Quality Forum endorsement for these four measures as required by section 1848(p)(2)(B)(ii) of the Act. We seek comment on our proposals to use these four measures in the va lue-based payment modifier for all groups of physicians with 25 or more eligible professionals. At this time we are not making proposal s regarding how to assess community-level performance and how such assessments could be included in the value-based payment modifier for groups of physicians. We seek comment, how ever, on whether measurement and adjustment at the community level would further our object ives to encourage and reward physicians and groups of physicians for furnishing high-quality, efficient, patient-centered clinical care. d. Proposed 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 fi nalized use of total per capita cost measures and per capita

costs measures for beneficiaries with four specific chronic conditi ons (chronic obstructive pulmonary disease, heart failure, coronary arte ry disease, and diabetes) for the value-basedCMS-1590-P 589

payment modifier. Total per capita costs include payments under both Part A and Part B. Total per capita costs do not include Medicare paymen ts under Part D for drug expenses. We propose to use at least a 60-day run out with a completi on factor from our Office of the Actuary (for example, claims paid through March 1 of th e year following December 31, the close of the performance period) to calculate the total per capita cost measures. We seek comment on this proposal.

We used these five measures in the 2010 Physician Feedback reports for individual physicians and physician groups; they also will be included in the 2011 Physician Feedback reports that we expect to disseminate later in 2012. We propose to contin ue to use these five measures to calculate the cost composite for th e value-based payment modifier. We also are developing plans to submit these per capita cost measures for National Quality Forum

endorsement. Several recipients of the 2010 Physician F eedback reports objected to being “held responsible” for total per capita costs of the bene ficiaries that they treat ed, because they could not affect the other costs incurred by the patient. In our view, the total pe r capita cost measure is just one metric used to assess the costs of car e. It has no impact until we use it to make comparisons among physicians and groups of physicians. In other words, it is not the measure itself (because it reflects the tota l cost of care beneficiaries recei ved), but how we use it to assess performance that matters. As described more fully in the composite scoring methodology proposals below, we propose to make cost co mparisons among groups of physicians using a similar beneficiary attribution methodology such that we make “a pples to apples” comparisons. We believe that this would be an appropriate ap proach to using the tota l per capita cost measure in the value-based payment modifier. We seek comment on these proposals. (1) Proposed Payment Standardization Methodology for Cost MeasuresCMS-1590-P 590

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 section 1848(n)(9)(C)(iii)) that eliminat e the effect of geographic adjustments in payment rates (as described in subsection (e))...” In layman’s term s, this directive requires us to standardize Medicare payments to ensure fair comparisons acro ss 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 Bo ston, Massachusetts 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. We have developed a detailed Medicare payment standardization methodology that excludes such geographic payment rate diffe rences. We developed the methodology with substantial stakeholder input, and we update it annually to incorporat e any payment system changes. More details of the CMS payment standardization methodology that we are proposing

can be found at http://www.qualitynet.org/dcs/ContentServe r?c=Page&pagename=Qn etPublic%2FPage%2FQne

tTier4&cid=1228772057350

. We have used this standardization approach, for example, in feedback reports we provide to hospitals related to the Me dicare Spending per Beneficiar y measure. The CMS payment standardization methodology includes a number of payment adjustments ac ross the spectrum ofCMS-1590-P 591

fee-for-service Medicare. For example, the methodology eliminates adjustments made to national payment amounts that reflect PE and re gional labor cost differences (measured by the GPCI and hospital wage index); substitutes a na tional amount when services are paid using a state fee schedule; eliminates s upplemental payments to hospitals that treat a high share of poor and uninsured patients (that is, Medicare dispro portionate share hospita l (DSH) payments) or that receive indirect graduate medical education (IME) payments; removes incremental payments for community hospitals and Me dicare-dependent hospitals above their base payments; and eliminates certain rural add-on payments for inpatient psychiatric hospitals and inpatient rehabilitation facilities. Outlier payments are tr eated as they would be if payments were not standardized, but they are adjusted to reflect wage differences. The CMS payment standardization methodology al so eliminates the effect of incentive payments under the PFS for physicians that furnish services in rural areas and other underserved communities such that they are not disadvantaged in the value-based payment modifier. For example, section 1833(m) of the Act provides in centive payments for physicians who furnish medical care services in geographic areas that are designated as primary medical care Health Professional Shortage Areas (HPSAs) under secti on 332 (a)(1)(A) of the P ublic Health Service (PHS) Act. The CMS standardi zation methodology does not include these incentive payments in standardized Part B costs so that physicians that furnish services in these areas are not disadvantaged in the value-based payment modi fier. We believe that by doing so we are complying with the requirement in Section 1848(p)(6) to “take in to account the special circumstances of physicians or groups of phys icians in rural areas and other underserved communities when applying the value-based payment modifier.”

We standardized the cost meas ures in the 2010 Physician Feed back reports to allow fair comparisons of costs across physicians. Howeve r, we note that the methodology used in theCMS-1590-P 592

2010 Physician Feedback reports differs from the methodology that we are proposing for the value-based payment modifier. Although that methodology achieved the same goal of ensuring fair comparisons, the standardization techniques used for the 2010 reports were performed at the regional level (because the reports focused on prov iders in four states) and used an averaging approach. Thus many of the national adjustments that we have proposed in this rule were not applicable to the 2010 Physician Fe edback reports. In the 2011 P hysician Feedback reports that we expect to disseminate later in 2012, we will use the national payment standardization methodology currently used to standardize paym ents in hospital feedback reports for the Medicare Spending per Beneficiary measure. We propose to use that same methodology to standardize cost measures for pur poses of the value-based paymen t modifier. We believe that this approach to payment standardization allows us to standardize payments nationally and to use a consistent approach across multiple programs and CMS initiatives. We seek comments on this proposal. (2) Proposed 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 pa tient 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 adjustedCMS-1590-P 593

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. In the Physician Feedback program, we a pplied a risk adjustment methodology to account for patient differences in per capita costs that were due to patient demographics such as age and gender, socioeconomic factors such as Me dicaid dual eligible st atus, and prior health

conditions that can affect a benefi ciary’s costs, regardless of the efficiency of the care provided. This risk adjustment methodology uses the CM S’ Hierarchical Condition Categories (HCC) model, which incorporates beneficiary characteris tics and prior year diagnoses to predict relative Medicare Part A and Part B payments. This mo del was originally developed under contract to CMS by researchers at Boston University and Res earch Triangle Institute (RTI) with clinical input from Harvard Medical School physicians based on an analysis of Medicare FFS beneficiaries diagnoses and expenditures. The m odel is updated every year to incorporate new diagnosis codes and is recalibra ted regularly to reflect more recent diagnosis and expenditure

data. The HCC model assigns prior ye ar ICD-9-CM diagnosis codes (each with similar disease characteristics and costs) to 70 generally high- cost clinical conditions to capture medical condition risk. The HCC risk scores also incorp orate patient age, gender, reason for Medicare eligibility (age or disability), and Medicaid eligibili ty status, which is in part a proxy for

socioeconomic status and reflects the greater resources typically us ed by beneficiaries eligible

for both Medicare and Medicaid. The risk adjustment model also includes the beneficiary’s endCMS-1590-P 594

stage renal disease (ESRD) status . More information about the ri sk adjustment model is on the

CMS Website at http://www.cms.gov/Medicare/ Medicare-Fee-for-ServicePayment/PhysicianFeedbackProgram/D ownloads/122111_Slide_Presentation.pdf

. We have examined the impacts of applyi ng the above risk adjustment methodology for physicians included at the group an d individual level in the 2010 P hysician Feedback reports and believe the approach provides a reasonable method to adjust per capita costs based on beneficiary characteristics. The results show that the risk adjustment methodology, in the aggregate, compresses the range of per capita co sts substantially and that a group of physicians’ total per capita cost measures can experience substant ial adjustment based upon the risk profile of the beneficiary population. For groups of physicians, the risk adjustment methodology had the effect of reducing the absolute difference be tween the groups with the lowest per capita cost and the highest total per capita cost by 55.7 percent. In partic ular, the lowest third of the groups were increased by an average of 6.2 percent a nd the most expensive third were lowered by 10.4 percent. The middle third, on average, were lo wered by 0.1 percent. The range of adjustments was between -10.3 percent and +8.2 percent. We found similar results at the individual level. We propose to use the same risk adjustment mo del for risk adjusting total per capita costs and the total per capita costs for beneficiaries with four chronic diseases (c oronary artery disease, COPD, diabetes, and heart failur e) as we have used for the group and individual 2010 Physician Feedback reports. We seek public comment on a pplying the same risk adjustment approach to the value-based payment modifier as w ith the Physician Feedback reports. (3) Episode-based Cost Measures Section 1848(n)(9)(A)( ii) of the Act as added by secti on 3003 of the Affordable Care Act, required CMS to develop a Medicare episod e grouper by January 1, 2012. Four contractors submitted prototype episode groupers to CMS in September 2011, and, after evaluating theCMS-1590-P 595

prototypes, we selected one to develop its prototype episode grouper into a comprehensive Medicare episode grouper. This process will entail additional technical and analytical development, as well as testing of the more fu lly developed episode grouping product. Initially the episode grouper will focus on selected chronic conditions and acute events. As development of the selected episode grouper continues, we e xpect to see the number of conditions increase. We plan to use the episode grouper in future Physician Feedback repo rts in order to test and gain stakeholder input into the developm ent of the episodes of care. Although the statute does not require the use of the episode-based cost measures for the value-based payment modifier, it requires that we use such cost measures in the Physician Feedback reports. We plan to include episode-based cost measures for several conditions in the Physician Feedback reports beginning in 2013 (bas ed on 2012 data). Interested parties that

commented on the CY 2012 PFS final rule with comment period (76 FR 73434) recommended that we use episode-based cost measures in the value-based payment modifier, rather than total per capita costs, because episode-based cost s are used in many private sector pay-forperformance programs and directly reflect care provided by physicians. We anticipate providing episode-based cost measures in the Physician Fe edback reports before proposing them for the value-based payment modifier in future rulemaking. 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. For example, for the PQRS administrative claims-based reporting option, we must attrib ute beneficiaries to groups of physicians (as identified by a single TIN) so that we are able to calculat e the relevant quality measure and cost measure performance rates. Likewise, we must attr ibute beneficiaries to groups of physicians that submit data on quality measures under the PQRS GPRO in order toCMS-1590-P 596

calculate the cost measure performance rates. In the 2010 Physician Feedback reports, we used two different attribution methodologies: one method for individual physicians (“degree of involvement method”) and another method for groups of physicians (“ plurality of care method”). This section discusses our proposal s for using these attribution me thods to calculate the quality and cost measures for the value-based payment m odifier. We note that the attribution methods do not impact beneficiaries’ choice of providers. We used the plurality of care method to at tribute beneficiaries in the 2010 Physician Feedback reports provided to th e group practices using the PQRS GPRO web-interface. 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 at the group of physicians. We used this attributed population to identify a sample of beneficiaries eligible for the quality measures reported via the PQRS GPRO

web-interface. We also calcu lated the per capita cost measur es based on this attributed population. In the discussion above regarding benefici ary attribution for groups of physicians choosing to report quality measures through the PQRS GPRO web-interf ace, we are seeking comment on the continued use of the “plurality of care” attribution me thodology or to use the Medicare Shared Savings Program attribu tion methodology for 2013 and beyond. The Medicare Shared Savings Program attribut ion methodology is described athttp://www.cms.gov/Medicare/Medicare-Fee-for-ServicePayment/sharedsavingsprogram/Statutes_Regulations_Guidance.html . For purposes of program alignment, we propose to use the same attri bution methodology that we finalize for the PQRS

GPRO web-interface to attribute beneficiaries to groups of physicians for purposes of the value-CMS-1590-P 597

based payment modifier. This proposal means that we would calculate the per capita cost

measures based on the same attributed benefi ciary population as we use for determining the quality measures for the group of physicians th at report PQRS quality data through: PQRS GPRO using the web-interface, claims, registri es, or EHRs; or PQRS administrative claimsbased option. We are concerned, however, that such an at tribution methodology may be too restrictive because it relies solely on office (E/M) visit code s and it could fail to attribute beneficiaries whom the group practices would iden tify as their beneficiaries. This situation may occur, for example, with single specialty groups such as ra diologists or anesthesiolo gists that do not submit claims that use E/M codes. For these reasons, we seek comment on whether to use an alternative approach (such as the “degree of involvement” method that is di scussed next) for all groups of physicians except those reporting quality measur es using the PQRS GP RO web-interface. We used the “degree of involvement” method to attribute beneficiaries for cost purposes to individual physicians in the CY 2010 Physic ian Feedback reports, which we produced for physicians (23,730 physicians in total) in four st ates: Iowa; Kansas; Missouri; and Nebraska. Under this attribution method, we classified the patients for wh ich a physician submitted at least one Medicare FFS Part B claim into three categ ories (directed, influe nced, and contributed) based on the amount of physician involvement with the patient: 16

● For directed patients, the physician billed for 35 per cent or more of the patient’s office or other outpatient evaluation and management (E&M) visits.

● For influenced patients, the physician billed for fewe r than 35 percent of the patient’s outpatient E&M visits but for 20 percent or more of the patient’s tota l professional costs.

● For contributed patients, the physician billed for fewe r than 35 percent of the patient’s

16 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.pdfCMS-1590-P 598

outpatient E&M visits and for less than 20 percen t of the patient’s total professional costs. The result of this methodology is that all of the beneficiaries for which a physician

submitted Medicare Part B claims are attribut ed to the physician, but the beneficiaries are classified according to the de gree of physician involvement with the beneficiary. We then calculated per capita cost measures for the benefici aries within each of thes e three classifications. In addition, a beneficiary can be attributed to more than one physician (and in different categories) if the beneficiary received services from more than one physician. Based on the CY 2010 reports, physicians that “directed” care billed, on average, approximately three E/M visits with the patien t, which represented ove r 64 percent of all E/M services furnished by the physicia ns treating the beneficiary. A lthough the directed attribution rule permits two physicians to be attributed to the same benefi ciary (because only two physicians could each have greater than 35 percent of the bene ficiaries E/M visits), in practice that rarely happened as a physician that direct ed care of a beneficiary had th e substantial majority of E/M visits, that accounted for 31 percent of costs am ong all physicians treating the beneficiary. These observations indicate the physician had substantial control over the patient’s care. In addition to primary care specialties, the other specialties with the greatest percentage of physicians directing care were rheumatology and oncology. Physicians that “influenced” ca re had, on average, one E/M vi sit with the beneficiary, but also had slightly over on e-third of the beneficiaries’ total Part B costs. Although the average number of E/M visits was low, the physician, on average, billed for one procedure during the year and this procedure was the most expensive one for the patient . This share of Part B costs was greater than physicians that directed or co ntributed to a beneficiar y’s care. Although the influenced attribution rule permits up to five physicians to influence care (because five physicians could each bill 20 percent of total Part B costs), this rarely happened as a physicianCMS-1590-P 599

that influenced care of a benefi ciary had, on average, approximat ely 84 percent of total Part B costs compared to other physicians that could ha ve influenced care. Medical specialists and surgeons, including ophthalmology, orthopedic surg ery, plastic and reconstructive surgery had the greatest percent of beneficiaries for which they influenced care. Physicians that “contributed” to care had, on average, less than one E/M visit per year with the beneficiary and billed for less than, on average, 20 percent of average beneficiaries’ total professional costs, thus i ndicating that the beneficiary recei ved care from many providers. On average, at least five physicia ns contributed to a beneficiary’ s care (not including those that directed or influenced that care). We calculated average total per capita cost measures for physician s by attribution rule

and these costs are shown in Tabl e 67. Not surprisingly, total pe r capita costs for directed and

influenced beneficiaries were a bout 50 percent of the total per capita costs of physicians with

contributed beneficiaries. The co sts in Table 67 show that benefi ciaries that receive care from multiple physicians, have substantially higher pe r capita costs. In addition, approximately 20 percent of Medicare benefi ciaries covered by the 2010 Phys ician Feedback reports had contributed care in which physicians only contributed to it. In other words, the care furnished

was neither “directed” nor “influenced” by a physician.

TABLE 67 : Average Per Capita Costs by Attribution Rule for Physicians in Iowa, Kansas, Nebraska, and Missouri Attribution Rule Average Total Per Capita Cost All physicians $18,831 Physicians with Directed Beneficiaries $10,719 Physicians with Influenced Beneficiaries $9,407 Physicians with Contributed Beneficiaries $20,243

We believe the value-based payment modi fier should address not only the care forCMS-1590-P 600

beneficiaries that a physician may “direct” or “i nfluence,” but also play a role in encouraging more efficient, not just more, care for beneficiarie s. We believe that any attribution rule should

consider the “contributed” benefici aries, especially those benefici aries that are neither directed nor influenced by other physicians, because the care of these beneficiaries is where the greatest potential for improved care and coordination reside. As explained more below, we seek commen t on whether to attri bute two populations of beneficiaries to groups of physicia ns using (1) a combination of th e directed and influenced rules and (2) the contributed rule. If we were to finalize this attribu tion methodology, we would calculate a separate per capita co st measures for each patient population. For example, we would calculate one total pe r capita cost measure for the gr oups of physicians’ “directed and influenced” beneficiaries and a second total per capita cost measure for the groups’ “contributed” beneficiaries. (In the value-based payment m odifier scoring methodol ogy section below, we explain our proposals for how to score and weight these measures to ensure fair comparisons among groups of physicians). First, we would attribute be neficiaries to a group of physicia ns that billed for 35 percent or more of the patient’s office or other outpatient (E/M) visits or at least 20 percent or more of the beneficiary’s total professional costs. This proposal combines the “directed” and

“influenced” methods discussed above. Combin ing “directed” and “influenced” beneficiaries into one attributed patient population is reasona ble because groups of physicians that care for these beneficiaries treat them, on average, more than any other physician or are responsible for a large percentage of professional costs. Co mbining the “directed” and “influenced” rules

attributes beneficiaries to the group of physicians over which they have substant ial control of

resource utilization.CMS-1590-P 601

Second, we would attribute a second and se parate patient population to the group of physicians which would consist of the remainin g beneficiaries to whom a group of physicians provided service but who were not attributed in the first patient popul ation (for example, beneficiaries for which the group of physicians did not bill for 35 percent of more of E/M visits and for less than 20 percent of professional costs). This rule corresponds to the “contributed” category discussed above. We believe that attr ibuting a second patient population to groups of physicians ensures accountability for all benefici aries to whom a group of physicians furnishes

services. We seek comment on whether to use the “degree of involveme nt” attribution method for all groups of physicians that submit data on PQRS quality measures through PQRS GPRO using claims, registries, and EHRs, and through the PQRS administrativ e claims-based option. f. Proposed 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 cost measures used in the va lue-based payment modifier be evaluated, to the extent practicable, based on a com posite of appropriate measures of costs. This section discusses our proposals for constructi ng the quality of care and cost composites. (1) Proposed Quality of Care and Cost Domains In many of our value-based purchasing programs such as Hospital Value-Based Purchasing and the Medicare Shared Savings Program, we selected and classified measures into quality domains that reflect important nati onal objectives for quality assessment and improvement. We believe it is important to ali gn the quality measures used in the value-based payment modifier with the national priorities es tablished in the National Quality Strategy. The National Quality Strategy outlined six priorities including:

● Make care safer by reducing harm caused in the delivery of care (patient safety).CMS-1590-P 602

● 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). 17 We propose to classify each of the quality m easures that we proposed for the value-based payment modifier into one of these six domains. We propose to weight each domain equally to form a quality of care composite. We believe this is a straight forward approach that recognizes the importance of each domain. Within each domain, we propose to weight each measure equally so that groups of phys icians have equal incentives 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 three domains contain quality information, each domain would be weighted at 33.3 percent to form the quality composite. In terms of the cost composite, we finaliz ed in the CY 2012 PFS final rule (76 FR 73434) total per capita costs (Parts A and B) and total pe r capita costs for beneficiaries with four chronic diseases (diabetes, CAD, COPD, heart failure). We propose to group these five per capita cost measures into two separate domains: total ove rall cost (one measure) and total costs for beneficiaries with specific c onditions (four measures). A separate domain for costs for beneficiaries with specific c onditions highlights our desire to incentivize efficient care for

17 National Quality Strategy, http://www.healthcare.gov/law/resources/rep orts/nationalqualitystrategy032011.pdf

.CMS-1590-P 603

beneficiaries with these conditions. Similar to the quality of care composite, we propose to weight each cost domain equally to form the cost composite and within the cost domains we propose 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 propose to weight the remaining cost m easures in the domain equally. If we were to attribute two patient populat ions to each group of physicians as discussed above regarding the “degree of involvement” a ttribution methodology, we propose to weight the measures in each population based on the group of physicians’ allowed charges for beneficiaries attributed to each population so that the cost co mposite accurately reflects the cost of care furnished. We seek comment on these proposals. Table 68 graphically depicts these proposals for the quality of care and cost composites and how they relate to the value-based payment

modifier.CMS-1590-P 604

TABLE 68: Relationship between Quality of Care and Cost Composites and the ValueBased Payment Modifier

(2) Proposed Value-Based Paymen t Modifier Scoring Methods We adopted different methods to score quali ty and cost measures in our value-based purchasing programs with each scoring methodology ta ilored to further the program’s purpose. For example, in the Medicare Shared Savings Pr ogram, we finalized a point system scoring methodology that assesses performance against es tablished Medicare program benchmarks for each quality measure. In the hospital-value ba sed purchasing program, we used a point system methodology that considered both a hospital’s ac hievement and improvement from a baseline performance period. We then translated these poi nts using a linear exchan ge function to develop a unique payment modifier for each hospital. For the value-based payment modifier, we believe the composite scoring methodology Quality of Care Composite Clinical care

Patient experience

VALUE MODIFIER

SCORE

Cost Composite

Total costs for beneficiaries with specific conditions Population/Community Health

Patient safety

Efficiency

Total overall costs Care coordinationCMS-1590-P 605

should keep intact the underlying distribution of performance rates so that the composite scores distinguish clearly between high a nd low performance. Groups of physicians also should easily be able to understand how performance on a qualit y or cost measure can affect their composite score, and hence their payment. We also belie ve that the composite scoring methodology should be used at all performance assessment leve ls (individual physician, group of physicians, hospital). Thus, because we are proposing to prov ide flexibility to groups of physicians as to the quality measures they report, the scoring met hodology needs to be able to compare “apples to apples.” Therefore, we propose a scoring approach th at focuses on how the group of physicians’ performance differs from the benchmark on a m easure-by-measure basis. For each quality and cost measure, we propose to divide the diffe rence between a group of physicians’ performance rate and the benchmark by the measure’s standa rd deviation. The benchmarks, as further described below, are the national means of the quality or cost measure. This step produces a score for each measure that is expressed in st andardized units. As discussed above, we propose to weight each measure’s standardized score equa lly with other measures in the domain to obtain the domain standardized score. We propose to weight the domain scores equally to form the quality of care and cost composites. We seek comment on this proposal. We believe that this proposal achieves our policy objective to disti nguish clearly between high and low performance and to allow us to creat e composites of quality of care for groups of physicians that report different quality measures. We also note that this approach is used in several private sector ph ysician profiling efforts. 18

Table 69 illustrates how we w ould score three hypothetical qu ality measures in the same quality domain under our proposal. A standardized score of zero means that performance is at

18 See e.g., Tufts Health Plan, “How Does Tufts Health Plan Tier Its Do ctors” available at http://www.tuftshealthplan.com/members/members.php?s ec=how_your_plan_works&content=your_choice&rightna v=your_choice_nav&WT.mc_id=members_leftnav_hypw_yourchoice&WT.mc_ev=clickCMS-1590-P 606

the national mean. Higher standardized scores (for example, 2.98) mean that performance is better than the national mean. Likewise, a large negative score means that performance is much lower than the national mean. In the exampl e shown in Table 69, the quality domain score would be 0.79 (the average of the three quality m easures’ standardized units) meaning the group of physicians scored slightly bette r than average in this quality domain. We would use the same method for the quality measures in the other domains that a group of physicians reported. TABLE 69: Example of Standardized Scores in one Quality Domain Group of Physicians’ Performance Rate Benchmark (National

Mean) Standard Deviation Standardized Unit Quality Measures Measure 1 95.0 93.5 3.3 0.47 Measure 2 71.4 86.3 13.9 -1.07 Measure 3 100.0 60.6 13.2 2.98 Quality Domain Score 0.79

(3) Proposed Benchmarks and Peer Groups for Quality Measures We propose that the benchmark for each quali ty measure be the national mean of each measure’s performance rate during the performa nce period. We propose to unify the calculation of the benchmark by weighting the performance rate of each physician and group of physicians submitting data on the quality measure by the number of cases used to calculate the performance rate. Alternatively, we could weight each qual ity measure reported by groups of physicians by the number of physicians in the group. We seek not to bias how physicians choose to report quality measures (that is, at the group or indi vidual level) by establishing different benchmarks for the same quality measures. Moreover, we be lieve beneficiaries are entitled to high quality care, regardless of whether a group of physicians or an individual physician furnishes it. In addition, we propose that the benchmar ks for quality measures in the PQRSCMS-1590-P 607

administrative claims-based reporting option be the national mean of each quality measure’s performance rate calculated at the TIN level. We propose to calculate the national mean by including the all TINs of groups of physicians with 25 or more eligib le professionals. We propose to weight the TIN’s performance rate by the number of cases 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 propose to publish the previous years’ performance rates (and standardized scores) on each quality measure. By doing so, groups of physicians will be better informed on how their performance may affect their payment in the coming year. We note, for example, that “topped out” quality measur es are unlikely to have significantly higher or

lower standardized scores for each measure b ecause performance is clustered around the mean, and this scoring method seeks to differentiate performance from the mean. We seek comment on these proposals. (4) Proposed 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 believe the same methodology shoul d be used to attribut e beneficiaries to the groups of physicians and to the groups of physicians in the peer group. We seek to compare like groups of physicians that use the same cost attribution methodology to ensure we are making “apples to apples” comparisons among groups of physicians. As discussed above, there are two ways to attribute beneficiaries to groups of physicians (“plurality of care” and “degree of involvement”). We have proposed to use th e “plurality of care” method for groups of physicians, regardless of whether they report da ta on PQRS quality measures using the GPRO web-interface, claims, registries, or EHRs; or the PQRS administrative claims-based option.CMS-1590-P 608

Thus, we propose that the peer group for the cost measures include all ot her groups of physicians for which we use the “plurality of ca re” to attribute beneficiaries. We seek comment on how the cost measure p eer groups would change if we adopt the “degree of involvement” methodology for groups of physicians other than groups of physicians using the PQRS GPRO we b-interface to submit da ta on quality measures. Alternatively, we seek comment on establis hing cost benchmarks on a quality measureby-quality measure basis. Under this alternative approach, we would set the benchmark as the mean per capita cost of the physicians or groups of physicians that reported the quality measure – whether it was reported by a group of physicians or at the individual physician level. This approach encourages groups of physicians to select to report quality measur es that reflect their practice patterns and patient populations more accurately. We seek comment on whether we should adopt this approach. We also note that although we are not proposing in this rule to use episode-based costs, the scoring methodology that we have proposed can readily be used to identify high and low performers relative to a national benchmark for ep isodes of care. For example, we could develop an episode cost profile for a ty pical beneficiary with macular de generation. We could then use the proposed scoring methodology to identify gr oups of physicians that have high and low episode costs relative to the benc hmark. In addition, if we were to use such episode-based cost measures, we could use attribution methods that seek to stratify bene ficiaries by relevant condition-specific characteristics to ensure fair and accurate peer group comparisons among physicians. We seek comment on our plans to use this approach in the future. (5) Proposed Reliability Standard

We believe it is crucial that the value-based payment modifier be based on quality of care and cost composites that reliabl y measure performance. Sta tistical reliability depends onCMS-1590-P 609

performance variation for a measure across physic ians (“signal”), the random variation in performance for a measure within a physician’s payment of attr ibuted beneficiaries (“noise”), and the number of beneficiaries attributed to the p hysician. In other words, reliability is defined

as the extent to which variation in the measure’ s performance rate is due to variation in the quality (or cost) furnished by the physicians (or group of physicians) rather than random variation due to the sample of cas es observed. Reliability is importa nt so that we can confidently distinguish the performance of one physic ian (or group of physicians) from another. 19 Potential reliability values range from zero to one, where on e (highest possible reliab ility) signifies that all

variation in the measure’s rates is the result of variation in differences in performance across physicians (or groups of physicians). Generall y, reliabilities in the 0.40-0.70 range are often

considered moderate and va lues greater than 0.70 high. Therefore, we propose to establish a minimu m number of cases in order for a quality or cost measure to be included in the quality of car e or cost composite. 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 cannot develop either a reli able quality of care composite or cost composite

because we do not have reliable domain inform ation, we would not calculate a value-based payment modifier and payment would not be aff ected. We recognize that a trade-off exists between developing a program that will eventually cover all physicians and groups of physicians and providing statistically reliable performance re sults. In this instance, as we increase the reliability threshold by requiring a higher minimu m case size threshold, the number of physicians and groups of physicians for which we can devel op a reliable quality of care or cost composite decreases. Based on an analysis of the indi vidual CY 2010 Physician Feedback reports and on

19 John L. Adams, “The Reliability of Provider Profiling, A Tutorial,” Rand Corporation (2009).CMS-1590-P 610

recent literature, we propose a minimum case size of 20 for both quality and cost measures to ensure high statistical reliability. 20 This proposal means that if a group of physicians does not have 20 or more beneficiaries elig ible for a particular measure, that particular measure would not

be included in the calculation of the value-based payment modifier. Our reliability analysis of the quality and cost measures in the 2010 individual Physician Feedback reports informs our minimum case size proposal. The average reliability of the total per capita cost measure assessed at the indi vidual level for physicians in all specialties was high (greater than .70) when the minimum case size was 20 or more. There was a slight increase in average reliability by increasing minimum case si ze to 30 cases. Increasing the minimum case size from 20 to 30, however, decreases the number of physicians for which we can calculate a reliable cost measure for physicia ns. The decrease in the number of physicians is small for some specialties (for example, internal medicine, fa mily practice) but is much greater for other specialties (for example, thorac ic surgery, allergy/immunology). Reliability was high for nine of the 15 admini strative claims based quality measures that we are proposing for purposes of the value-base d payment modifier for the PQRS administrative claims-based reporting option when the mini mum case size was 20 or greater. Average reliability increases slightly by increasing case size to 30, but the number of physicians decreases, on average, by 30 percent of eligib le physicians. We anticipate that statistical reliability of the quality and cost measures wi ll 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. We seek comment on these proposals. g. Proposed Payment Adjustment Amount

20 Robert L. Houchens, “The Reliability of Physician Cost Profiling in Medicare,” (Aug. 2010) (Describing how for most physician specialties, Medicare physician cost profile scores are substantially more reliability than those derived from commercial settings,)CMS-1590-P 611

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 due to high performance and decrease for others du e to low performance, but the aggregate amount of Medicare spending in any given year for physic ians’ 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, under PQRS, a physician who does not satisfactorily submit data on quality measures during the app licable reporting period in 2013 have their fee schedule amount reduced by 1.5 percent for serv ice furnished 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 thereaf ter, reporting period or periods that fall two years prior to the year in which the PQRS paymen t adjustment is assessed). However, as noted previously in this preamble, individual physicia ns and groups of physicians that satisfactorily submit data on PQRS quality measures via any of the reporting methods proposed for the 2015 and 2016 PQRS payment adjustment would avoi d the PQRS downward payment adjustment. The second payment adjustment is for physicians that are not meaningful EHR users. Section 1848(a)(7) of the Act provides for a downward pa yment adjustment of 1 percent in 2015 (based on performance in 2013), 2 percent in 2016 (p erformance in 2014), and 3 percent in 2017 (performance in 2015). We note that the adjust ment in 2015 for not being a meaningful EHRCMS-1590-P 612

user is increased by 1 percentage point (to -2 percent) if the physician was subject to the eRx Incentive Program payment adjustment for 2014. To balance our goals of beginning the implem entation of the value modifier consistent with the legislative requirements and to give us and the physician community experience in its operation, we propose to separate groups of physicia ns with 25 or more eligible professionals into two categories. For those groups of physicians that have met the criteria for satisfactory reporting established for the value-based payment modifier and request that their value-based payment modifier be calculated using a quality-tiering approach, we pr opose that the maximum payment adjustment be -1.0 percent for poor performan ce (Table 70 displays the different downward payment adjustments depending upon a group of physicians’ quality and cost tiers). We recognize that 2015 is the in itial year for the value-based modi fier and, thus, we are providing for a very modest adjustment for the program’s initial years. A payment adjustment of -1.0 percent means that groups of physicians would receive 99.0 percent of the PFS payment amount for the service involved. Due to the BN requirement , we are not proposing the exact amount of the upward payment adjustments for high performa nce under the value-based payment modifier because the upward payment adjustments (in the aggregate) will have to balance the downward payment adjustments in order to achieve BN. Thus, we propose 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. Our proposals regarding the payment modifier scor ing models in the next section explain how we proposed to calculate upward ad justments for high performance. For groups of physicians with 25 or more elig ible professional that have not met the criteria for satisfactory reporti ng established for the value-base d payment modifier (includingCMS-1590-P 613

those groups that have not participated in a ny of the PQRS reporting mechanisms), we propose to set their value-based payment modifier at -1.0 percent. We arrived at our proposal for a -1.0 percent downward adjustment using the following rationale. Section 1848( p) of the Act requires us to differentiate payment based on a comparison of quality 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 ba sed on costs only. A cost-only comparison would set a lower downward adjustment for low-cost gro ups than for high-cost groups. Due to the fact that the value-based payment modi fier is just starting in 2015, we do not wish to apply a greater downward payment adjustment for non-satisfactory reporters than we are proposing for the low quality/high cost groups that requ est that their value-based paymen t modifier be calculated using a quality-tiering approach. Thus, we propose to equalize the downward payment adjustment across these groups of physicians, despite the fact th at they may have differe nt costs. We seek comment on this approach. h. Proposed Value-Based Payment Modifier Scoring Methodology Section 1848(p)(1) of the Act requires the Secretary to establish 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. This section discusses our proposals for comparing the quality of care furnished to cost for those groups of physicians that request their value-based payment modifier be calculated using a quality-tiering approach. In making our proposals, we developed two models that compare the quality of care furnished to costs: a quality tier model and a total performan ce score model. We propose theCMS-1590-P 614

quality-tiering model for the value-based paymen t modifier, but we seek comment on the total performance score model. We also note that the literature on physic ian pay-for-performance includes other models, such as one based on an efficient frontier, that we are not proposing

here. 21 We seek comment on these proposals. (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 propose 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 a ssessment). We propose to assess meaningful differences as those performance scores that are at least one standard deviation from the mean. We propose to assess precisi on by requiring a group of physicians ’ score to be statistically different from the mean at the 5.0 percent leve l of significance. We seek comment on these proposals and on whether we should only examine mean ingful differences that are at least two or three standard deviations away from the mean. We also seek comment on whether to define the high and low categories of the quality compos ites as a fixed percentage (for example, 2.5 percent) of the number of groups of physicians or of the amount of payments under the PFS. Such an approach would minimize the number of group of physicians subject to payment adjustments.

21 David Knutson, et al, “Alternative Approaches to M easuring Physician Resource Use,” Second Interim Report (Dec. 2010), available at http://www.cms.gov/Research -Statistics-Data-and-Systems/Statistics-Trends-andReports/Reports/downloads/Knutson_MN_2nd_InterimReport_AltApproaches_2010.pdfCMS-1590-P 615

Likewise, we propose to identify those groups of physicians that have cost composite

scores that are statisti cally different from the mean cost composite score of all groups of physicians. We propose to classify 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 reference to quality composite. We propose to assess meaningful differences as those performa nce scores that are at least one standard deviation from the mean and we propose to as sess precision at the 5.0 percent level of significance. We seek comment on these propos als and on whether we should only examine meaningful differences that are at least two or three standard deviations away from the mean.

We also seek comment on whether to define th e high and low categories of the cost composites as a fixed percentage (for example, 2.5 percent) of the number of groups of physicians or of the amount of payments under the PFS. We propose 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 70.

TABLE 70: 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 addi tional +1.0x if reporting measures and average beneficiary risk score in the t op 25 percent of all risk scores.

We propose to establish the upward paymen t adjustment factor (“x”) after the performance period has ended based on th e aggregate amount of downward payment adjustments. We also propose to aggregate the downward payment adjustments in Table 70 with the downward adjustment for groups of physicians with 25 or more eligible professionals firstCMS-1590-P 616

and then to solve for the upward payment adju stment 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 pe rcent such that high quality/low cost groups of physicians would r eceive a 1.5 percent (2 x 0.75) upward payment adjustment during the payment adjustment period. We also propose an additional incentive for gr oups of physicians to furnish care to highrisk Medicare beneficiaries. We seek to ensu re that the value-based payment modifier does not cause unintended consequences in which groups of physicians decline to treat the most difficult cases. In particular, we propose that the sc oring methodology 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 propose to increase th e 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 are not proposing this additional upward payment adjustment (+1.0x) for groups of physicians that select the PQRS administrative claims-based reporting option. We propose this quality-tiering scoring methodol ogy because it compares the quality of care furnished to cost as required by the statute. It also allows physicia ns to understand clearly how their payment is affected by their scores on the quality of care and cost composites. We

also believe it is a re asonable way to start to modify physician payment because it clearly distinguishes the outliers (for example, high quality/low cost compared to low quality/high cost)CMS-1590-P 617

from mean performance. The framework also allo ws us to fine tune payment adjustments as we gain greater experience with the proposed methodologies. We seek comment on this proposal and on th e proposed scoring methodologies. We seek comment in particular on whether it is appropria te to apply the same upward payment adjustment in Table 70 to groups of physicians classifi ed as high quality/medium cost and medium quality/low cost. In addition, we seek comment on whether we should not provide as great an upward payment adjustment for those groups of phys icians that select to report under the PQRS via the administrative claims-based reporting option, so that we encourage greater PQRS participation. (2) Total Performance Score A second approach to scoring the value-base d payment modifier is a total performance score approach. This approach allows us to develop a unique value-base d 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. Under this approach, we could calculate a total performance score (TPS) by e qually weighting the quality of care and cost composites. A negative score for the quality composite (Physician Group 2 in Table 71) means the group of physicians performed below the nationa l average on the relevant quality measures. Likewise, a negative score for the cost composite means the group of physicians had higher costs than the national average. A score of zero mean s that the group of physic ians performed at the national average. The example in Table 71 illust rates how we could calc ulate the TPS for three groups of physicians. In this example, P hysician Groups 1 and 3 are above average and Physician Group 2 is below average. TABLE 71: Example of Total Performance Score Quality Composite (50%) Cost Composite (50%) TPSCMS-1590-P 618

Physician Group 1 .9 .2 .55 Physician Group 2 -.9 -1.2 -1.05 Physician Group 3 2.2 1.2 1.70

We could develop an exchange function in which we translated the TPS into a unique value-based payment modifier for each group of physicians. This method would be similar to the approach we use in the Hospital Value-Ba sed Purchasing program where we use a linear exchange function to develop a unique payment fo r each hospital. This approach results in a continuous array of unique value-based payment m odifiers such that ther e are no longer cut-off points between high and low perf orming groups of physicians. Ra ther, each group of physicians’ payment would be modified under this approach. We believe the quality-tiering approach may better compare the quality of care furnished to costs. We also believe that the quality-tier ing approach is more tran sparent because groups of physicians may be more aware of the level at wh ich quality and cost performance is likely to result in payment adjustment. However, we se ek comment on these observations and whether to use the total performance scor e methodology rather than the qu ality-tiering methodology for the value-based payment modifier. If we were to use a total performance score methodology, we

also seek comment on the we ights to be given to quali ty and cost composites. 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:

● 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 ofCMS-1590-P 619

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 prohibition of admi nistrative 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 a mechanism is needed for groups of physicians to review and to identify any possible errors prior to applicat ion 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 that encompass a ll physicians (individually or in groups of physicians, as applicable); these reports would be the basis of the value-based payment modifier in 2015. We propose that these reports would co ntain, among other things, the quality and cost measures and measure performance and benchmarks used to score the com posites, and quality of care and cost composite scores, and the value-based payment modifier amount. After the dissemination of the Physician F eedback reports in the fall of 2014, we propose that physicians would be able to e-mail or call a technical help desk to inquire about their report

and the calculation of the value- based payment modifier. We e nvision this process to help educate and inform physicians about the value- based payment modifier, especially for those groups of physicians that have elected that thei r value-based payment modifier be calculated using a quality-tiering approach. We note that because we have proposed to align our proposals with the PQRS satisfactory re porting criteria, groups of physic ians will be able to avail themselves of the informal review process regard ing the PQRS payment adjustment as well. WeCMS-1590-P 620

do not envision providing opportun ities for review of a value-based payment modifier. 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 methodologies we are proposing 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 affect their payment under the PFS. j. Physician Scenario and the Valu e-Based Payment Modifier Proposals The following example summarizes and pulls together our proposals for the payment modifier based on a group of physicians that sa tisfactorily reports quality measures through the PQRS GPRO web-interface and elects to have the value-based payment modifier calculated using the proposed quality-tiering methodology.

● Quality measures : A large medical practice group with more than 100 physicians each billing under the same TIN could choose to submit data on a common set of quality measures via the PQRS web-interface. This group of physicia ns would need to meet the applicable and proposed self-nomination requireme nts under the PQRS to report da ta under this option. After approval to participate, CMS would provide the group of physic ians in early 2014 a list of patients pre-loaded into the GP RO web-interface on which they w ould be required to report the measures to CMS. They would complete the web-interface during the fi rst calendar quarter of

2014.

● Composite quality score : To arrive at the quality com posite score, we would create a standardized score for each quality measure included in the GPRO web-interface and then combine these scores into the quality composite. Specifically, for each measure we would divide the difference between the group’ s performance rate and the benchmark (the national meanCMS-1590-P 621

computed across all groups of physicians and in dividual physicians submit ting data on the quality measure) by the measure’s standard deviation to create a standardized unit. Standardized units representing each measure are then combined into quality domains with each measure weighted equally. We would then equally weight the domai ns to form the quality composite score.

● Composite cost score : CMS will calculate five cost measures for the attributed

beneficiaries. The standardized cost score com posite is comprised of two cost domains: total per capita cost and condition-specific per capita costs. Each domain is weighted equally. For each cost measure, the difference between the group’s performance and the national mean is divided by the standard deviation computed across all groups of physicians.

● Payment modifier : Using the quality composite, we would identify groups of physicians that have quality composite scores th at are significantly different from the mean quality composite score of all gr oups of physicians. We would cl assify the groups of physicians into high, average, and low quality based on whethe r they are statistically above, not different from, or below the mean. We would also identify groups of physicians that have cost compos ite scores that are significantly different from the mean cost compos ite score and classify groups of physicians into high, average, and low cost. We would then comp are the quality of care composite classification with the cost composite classification to de termine the payment modifier according to the

amounts in Table 70. Assuming the group of physicians had high quality and average cost, it would be eligible for an upward payment adjustment of +1x on eac h of its claims submitted for payment under the PFS during 2015. If the beneficiaries attributed to the group of physicians had an average risk score that was in the top 25 per cent of all beneficiary risk scor es, the upward payment adjustmentCMS-1590-P 622

would be increased to +2x. We would indicate the exact am ount of the upward payment adjustment in the Physician Feedback repor t that we produced in the fall of 2014. (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 to physicians practicing in the following States: Iowa, Kansas, Missouri, and Nebraska. (a.) CY 2010 Physician Group Feedback Reports based on 2010 data and disseminated in 2011 In September 2011, we produced and distri buted confidential Physician Feedback reports to each of the 35 medical group practices that participated in the 2010 GPRO of the PQRS. Each report provided information on the quality of care and res ource use for Medicare FFS beneficiaries treated by the medical gr oups in 2010. More information about the methodologies used in these report s and the aggregate findings from these reports is available at http://www.cms.gov/physicianfeedbackprogram

. To participate in the 2010 PQRS GPRO, a group practice had to be a single provider entity, identified by its TIN, with at least 200 eligible prof essionals. Thirty-five groups, encompassing 24,823 eligible professionals, part icipated in the 2010 PQRS GPRO reporting option. On average, each group pr actice contained the following t ype of medical professionals: primary care (27 percent), medical specialties (20 percent), surge ons (13 percent), other medical professionals (36 percent) and ER physicians represented less than 1 percent. Despite the average group practice profile, five group practices were com posed of substantially moreCMS-1590-P 623

medical specialists and surgeons than primary care professionals. A professional’s medical specialty was determined based on the CMS medical specialty code listed most often on their

2010 Part B claims. For each of the 35 participating group practices, we attributed Medicare FFS beneficiaries to the group practi ce if eligible professionals in the group practice billed for at least two office visits or other outpatient E&M services and the group practice had the plurality of E&M charges for that benefi ciary. The average beneficiary population attributed to a group practice was 12,550 beneficiaries with the smalle st group practice attributed 2,424 beneficiaries and the largest with 31,006 beneficiaries. In 2010, each beneficiary that was attributed to a group practice ha d an average of 10 total E&M visits in 2010 (both to physicians in and outside the group practice), ranging from a low of nine visits per group practice to a high of 14 visits per group practice. Seven of these E&M visits, on average, were with physicians in the group practice, rangi ng from a low of five E&M visits to a high of nine E&M visits with physicians in the group practice. Thus, the GPRO groups provided not only th e plurality, but the large majority, of E&M visits to the beneficiaries attributed to that group practice. On average, the group practices accounted for 78 percent of attributed beneficiaries’ E&M visits. Primary care physicians, on average among all 35 groups, furnished over half (53 percent) of the plurality of E&M visits within the group practice, followed by medical specialists at 27 percent. Surgeons provided 11 pe rcent of the plurality of E&M visits and other physicians furnished 9 percent. We note that fo r five group practices medi cal specialists, rather than primary care providers, furnished the plurality of care for the attributed beneficiaries. Table 72 shows the mean performance rate and the performance rates for the 10th, 50 th

, and 90 th percentiles for each of the 26 quality measures that were included in the PQRS GPROCMS-1590-P 624

measure set for 2010. We calculated the performa nce rates based on the data submitted by each of the group practices. Table 72 also shows the mean performance rate for those 19 measures that were included in the PQRS GPRO that eligib le professionals also re ported at an individual level through the PQRS. The m ean group practice perfor mance rate was equal to or higher than the individual performance rate for 16 of the 19 measures. TABLE 72: Performance Rates on 26 Quality Mea sures for Individual Eligible Physicians and Groups

Performance Rate for All 2010 GPROs Percentile Measure Number Measure Title 2010 Average Individual Performance Rate/Eligible Professional Mean 10 th 50 th 90 th

DIABETES GPRO DM-1 Diabetes Mellitus: Hemoglobin A1C Testing NA 93% 88% 94% 98%

GPRO DM-2* Diabetes Mellitus: Hem oglobin A1C Poor Control in Diabetes Mellitus 22% 22% 11% 21% 39%

GPRO DM-3 Diabetes Mellitus: High Blood Pressure Control in Diabetes Mellitus 59% 58% 49% 57% 67%

GPRO DM-5 Diabetes Mellitus: Low Density Lipoprotein ( LDL-C) Control in Diabetes Mellitus 57% 54% 41% 55% 66%

GPRO DM-6 Diabetes Mellitus: Urine Screening for Microalbumin or Medical Attention for Nephropathy in Diabetic Patients 74% 89% 82% 89% 96%

GPRO DM-8 Diabetes Mellitus: Foot Exam 72% 61% 16% 69% 86%

GPRO DM-9 Diabetes Mellitus: Lipid Profile NA 84% 75% 84% 93%

HEART FAILUREGPRO HF1 Heart Failure: Left Ventricular ( LV F) Assessment 46% 86% 68% 93% 97%

GPRO HF2 Heart Failure: Left Ventricular ( LVF) Testing NA 86% 68% 90% 98%

GPRO HF3 Heart Failure: Weight Measurement NA 86% 79% 88% 96%

GPRO HF5 Heart Failure: Patient Education 43% 77% 54% 83% 97%

GPRO HF6 Heart Failure: Beta Blocker Therapy for Left Ventricular Systolic Dysfunction ( LVSD) 83% 92% 86% 95% 99%

GPRO HF7 Heart Failure: Angiotenson-Converting Enzyme (ACE) Inhibitor or Angiotensin Receptor Blocker ( ARB) Therapy for Left Ventricular Systolic Dysfunction ( LVSD) 86% 90% 82% 91% 97%

GPRO HF8 Heart Failure: Warfarin Therapy For Patients With Atrial Fibrillation 72% 79% 62% 82% 94%

CORONARY ARTERY DISEASECMS-1590-P 625

Performance Rate for All 2010 GPROs Percentile Measure Number Measure Title 2010 Average Individual Performance Rate/Eligible Professional Mean 10 th 50 th 90 th

GPRO CAD-1 Coronary Artery Disease ( CAD): Oral Antiplatelet Therapy Prescribed for patients with CAD 85% 85% 50% 93% 97%

GPRO CAD-2 Coronary Artery Disease ( CAD): Drug Therapy for Lowering LDL- Cholesterol 75% 90% 85% 92% 97%

GPRO CAD-3 Coronary Artery Diseas e ( CAD): Beta Blocker Therapy for CAD Patients with Prior Myocardial Infarction 71% 87% 76% 88% 95%

GPRO CAD-7 Coronary Artery Disease ( CAD): AngiotensinConverting Enzyme ( ACE) Inhibitor or Angiotensin Receptor Blocker ( ARB) Therapy for Patients with CAD and Diabetes and /or Left Ventricular Systolic Dysfunction ( LVSD) 67% 83% 75% 84% 91%

HYPERTENSION GPRO HTN-1 Hypertension ( HTN): Blood Pressure Measurement NA 92% 72% 98% 100%

GPRO HTN-2 Hypertension ( HTN): Blood Pressure Control NA 68% 58% 68% 76%

GPRO HTN-3 Hypertension ( HTN): Plan of Care NA 56% 21% 61% 79%

PREVENTIVE CARE AND SCREENING GPRO PREV-5 Preventive Care and Screening: Screening Mammography 54% 74% 63% 76% 85%

GPRO PREV-6 Preventive Care and Screening: Colorectal Cancer Screening 52% 60% 37% 64% 76%

GPRO PREV-7 Preventive Care and Screening: Influenza Immunization for Patients > 50 Years Old 51% 67% 50% 67% 79%

GPRO PREV-8 Preventive Care and Screening: Pneumonia Vaccination for Patients 55% 62% 40% 62% 86%

• DM-2 is a measure of poorly controlled blood sugar: Higher scores (and percentile rank ings) on this m easure reflect worse performance. The group practice performance rates were sta tistically reliable at a high level across the vast majority of the measures. We examine relia bility because the clini cal measures are derived from samples of the group practice’ s attributed beneficiaries. In this context, reliability means the group practices’ performance rates would be similar or the same if a different sample population of the group practice were used for qua lity measurement. The average reliability score for the group practices’ quali ty measures related to corona ry artery disease ranged from 0.86 to 0.99, for diabetes from 0.87 to 0.99, for h eart failure from 0.79 to 0.99, for hypertension from 0.89 to 1.00, and for the preventive measures from 0.94 to 0.98. All groups’ quality

measures achieved at least a 0.50 score with most group practices well above that level.CMS-1590-P 626

The percentage of primary care physicians in a group practice did not correlate with higher performance on the clinical care measures , even though the 26 quality measures focused on effective primary care. As noted above, in five group practices, medi cal specialists rather than primary care providers furnished care to the ma jority of attributed be neficiaries. Two of these five group practices were among the top five group practices ove rall across all quality

measures. In addition to the 26 quality measures includ ed in the GPRO, the reports also contained each group practice’s performance on measures of avoidable hosp italizations for six ambulatory care sensitive conditions (ACSCs). These ar e conditions for which outpatient care can potentially prevent a hospital admission. The me asures were based on measures developed by the Agency for Healthcare Research and Quality (AHRQ) and more information can be found at http://www.qualityindicators.a hrq.gov/modules/pqi_overview.aspx

. The six ambulatory care sensitive conditi ons include: (1) bacterial pneumonia; (2) urinary tract infection (UTI); (3) dehydration; (4) heart fail ure (HF); (5) chronic obstructive pulmonary disease (COPD); and (6) diabetes – a composite measure based on short-term diabetes complications, uncontro lled diabetes, long-term diabet es complications, and lower extremity amputation for diabetes. Table 73 shows the mean, as well as minimum, and maximum performance rate (as expressed in even ts per 1,000 beneficiaries) for each of the six ACSC measures of potentially pr eventable hospitalizations.

TABLE 73: Performance Rates for the ACSCs (ACSC) Mean Minimum Maximum Diabetes 25 7 39

COPD 95 53 142

CHF 122 66 200 Bacterial Pneumonia 12 7 20 UTI 8 4 13 Dehydration 3 0 11CMS-1590-P 627

We also examined five measures of cos t: total per capita costs for beneficiaries attributed to the group practice a nd total per capita for beneficiar ies that had the following four chronic conditions: diabetes, he art failure, chronic obstructive pul monary disease, and coronary artery disease. In calculating these measures, we first standardized the Medicare payments to ensure fair comparisons. Geographic variations in Medi care payments to providers can reflect factors unrelated to the care provided to beneficiaries. All Medicare payments have been standardized such that a given service is priced at the same level across all providers within the same facility type or setting, regardless of geographic location or differences in Medicare payment rates among facilities. More information about how CM S standardized payments can be found in the September 2011 document describing the methodologies used in the 2010 QRURs, which can

be accessed at http://www.cms.gov/PhysicianFeedbackProgr am/Downloads/2010_GPRO_QRUR_Detailed_M ethodology.pdf

. The standardized total pe r capita costs for the 35 group practices for attributed beneficiaries was on average, $13,135. Thus on average, Medicare paid providers $13,135 per beneficiary attributed to each group practice. The range of to tal per capita costs was $9,124 to $24,480 and an absolute difference of $15,536 per beneficiary. We applied a risk adjustment methodology to adjust these tota l per capita costs for patient demographics, socioeconomic factors, and prior health conditions, recognizing that physiologic differences among benefici aries can affect their medical co sts, regardless of the care provided. This risk adjustment methodology is based on the CMS’ Hierarchical Condition Categories (HCC) model that assigns ICD-9 di agnosis codes (each with similar disease characteristics and costs) to 70 clinical conditions to capture medical condition risk. The HCCCMS-1590-P 628

risk scores also incorporate patient age, ge neral reason for Medicare eligibility (aged or disabled), and Medicaid eligibility. The risk adjustment mo del also included the beneficiary’s end stage renal disease (ESRD) status. More information about how CMS risk adjusted per capita costs can be found in the September 2011 document describing the methodologies used in the 2010 QRURs, whic h can be accessed at http://www.cms.gov/PhysicianFeedbackProgr am/Downloads/2010_GPRO_QRUR_Detailed_M ethodology.pdf After risk adjustment, the adjusted aver age total per capita co sts was $12,652 with a range of $9,932 to $16,736 and an absolute differe nce of $6,804. Thus the risk adjustment methodology had the effect of reducing the abso lute difference between the groups with the lowest and highest total per capita range 55.7 percent. In partic ular, the lowest third of the groups were adjusted upward by an average of 6.2 percent and the most expensive third were lowered by 10.4 percent. The middle third, on average, were adjusted downward by 0.1 percent, but the range of adjust ments was -10.3 to +8.2 percent. Moreover, three of the five group practices for which medical sp ecialists provided the plurality of care to attributed beneficiaries ha d their costs risk adjusted downward. Two of these five groups had their unadjuste d per capita costs adjusted upward. The physician feedback reports also showed the percentage of prof essionals who did not bill under the group practice’s TIN who treated the be neficiaries attributed to the group practice. On average, 42 percent of the professionals that cared for attributed pati ents were outside the group practice. The range was from 18 to 84 pe rcent. We also found a weak association between the percent of professi onals who did not bill under th e group practice’s TIN and total per capita costs for the attributed be neficiaries. The correlation was 0.12. All 35 group practices achiev ed statistical reliability scor es greater than 0.70 for theCMS-1590-P 629

overall per capita cost measures and the four subgroup-specific cost measures. In particular, the group practices achieved an average reliability score of 0.99 for the overall per capita cost measure. In addition, all 35 group practices achie ved a reliability of greater than 0.70 across all sub cost categories. The aver age reliabilities were 0.93 for h eart failure, 0.91 for COPD, 0.95 for diabetes, and 0.96 for CAD. Although the sample of group practices was small (35), we found almost no association between quality of care furnished and the tota l risk-adjusted per capita cost for each group practice. We constructed a simple quality sc ore by taking the average of the 32 performance rates (26 clinical quality measur es and six ACSC rates). We translated the ACSC rates into percentages with the lowest AC SC rate equal to 100.0 percent (because lower rates are better) and the highest ACSC rate equal to 0.0 percen t. Table 74 shows a scatter diagram of the relationship between the quality of care furnished by each gro up practice and the total riskadjusted per capita cost. The correlation between the tw o variables is 2.0 percent. TABLE 74: Quality of Care Compared To Cost

(b.) Individual Physician Feedback reports based on 2010 data and disseminated in 2012.CMS-1590-P 630

In March 2012, we produced and made avai lable for download confidential individual Physician Feedback reports for 23,730 physicians en rolled in Medicare a nd practicing in Iowa, Kansas, Missouri, and Nebraska. Each report provided information on the quality of care and

resource use for Medicare FFS be neficiaries treated by the physician in 2010. Each report contained two sets of quality measures for Medicare beneficiaries: measures physicians reported in the PQRS via the claims-based reporting methodology, and quality measures calculated by CMS that relied solely on Medicare administrative claims data. Approximately 25 percent (5,891) of th e 23,730 physicians reported on one or more PQRS measure in 2010. The five sp ecialties with the highest partic ipation rates, as a percentage of the total number of physicians in that specialty, were Ophthalmology, Anesthesiology, Gynecology/Oncology, Pathology, and Geriatric Medicine. Physicians reported 3.7 PQRS measures on average. The maximum number of measures reported was 30, by a family practitioner. The PQRS performance rates were str ongly skewed upward and compressed for the physicians in the four states. For approxima tely three quarters of the measures, the 50 th percentile was 100 percent. For approximately one-third of the measures, the 25 th percentile was 100 percent. The most frequently repor ted PQRS measure was “Health Information Technology: Adoption/Use of El ectronic Health Records”, re ported by 1,494 physicians (6.3 percent). The 2010 Reporting Experience report has more information on PQRS performance

rates nationwide and it is available at http://www.cms.gov/Medicare/Q uality-Initiatives-PatientAssessment-Instruments/PQRS/index.html?redirect=/PQRI

. The reports also contained information on up to 28 administrative claims-based quality measures (and 13 sub-measures for a total of 41 measures) depending upon whether the physician treated at least one beneficiary that was eligible for the measure, that assessedCMS-1590-P 631

whether Medicare FFS beneficiaries received r ecommended primary care and preventive care services. We calculated these measure perfor mance rates solely from Medicare FFS claims data. The measurement year used for calcula ting performance was January 1 - December 31, 2010; claims were available for a one-year l ook-back period to January 1, 2009, for measures requiring a look-back period. Specifications for these m easures are available at http://www.cms.gov/PhysicianFeedbackProgram /Downloads/claims_based_measures_with_des criptions_num_denom_excl.pdf

. On average, a physician’s report containe d information on 30 of 41 measures. The reports provided this information for any benefi ciary to whom the physic ian furnished at least one service, even if the physician did not pr ovide the treatment indicated by the quality measure. We provided this information because we believe it is critical to inform physicians about the quality of care that their benefici aries received for primary care and preventive services from any Medicare FFS physician. More over, physicians may be unaware of the care

that that their beneficiaries receive. Table 75 shows the percentage of Medicare FFS patients who received the treatment indicated by the quality measure. There is room for improvement for physicians to provide basic recommended servi ces in many clinical ar eas, especially those where the percentage of beneficiaries receiving the indicated treatment is less than 50 percent. TABLE 75: Physician Performance on Medicare Claims–Based Quality Measures for 2010 QRUR Physicians (Iowa, Kansas, Missouri, Nebraska)

Mean Performance Rate Clinical Condition and Measure Physicians in Iowa, Kansas, Missouri, and Nebraska Specifications for these clinical measures are posted at http://www.cms.gov/PhysicianFeedbackProgram/Downloads /claims_based_measures_with_descriptions_num_denom_excl.pdf

. Number of Physicians Included Percentage of Medicare Patients Who

Received the Service Chronic Obstructive Pulmonary Disease (COPD) Pharmacotherapy Management of COPD Exacerbation

1. Dispensed Systemic Corticosteroid Within 14 Days of Event 18,472 66% 2. Dispensed Bronchodilator Within 30 Days of Event 18,472 66%CMS-1590-P 632

Mean Performance Rate Clinical Condition and Measure Physicians in Iowa, Kansas, Missouri, and Nebraska Specifications for these clinical measures are posted at http://www.cms.gov/PhysicianFeedbackProgram/Downloads /claims_based_measures_with_descriptions_num_denom_excl.pdf

. Number of Physicians Included Percentage of Medicare Patients Who

Received the Service Use of Spirometry Testing to Diagnose COPD 22,290 33% Bone, Joint, and Muscle Disorders Osteoporosis Screening for Chronic Steroid Use 17,046 58% Osteoporosis Management in Women ≥ 67 Who Had a Fracture 19,678 14% Disease-Modifying Antirh eumatic Drug Therapy fo r Rheumatoid Arthritis 18,094 77% Cancer Breast Cancer Surveillance for Women with a History of Breast Cancer 15,550 78% PSA Monitoring for Men with Prostate Cancer 17,598 89% Diabetes Dilated Eye Exam for Beneficiaries ≤ 75 with Diabetes 23,012 71% HbA1c Testing for Beneficiaries ≤ 75 with Diabetes 23,012 87% Urine Protein Screening for Beneficiaries ≤ 75 with Diabetes 23,012 74% Lipid Profile for Beneficiaries ≤ 75 with Diabetes 23,012 77% Gynecology Endometrial Sampling or Hysteroscopy with Biopsy Before Endometrial Ablation Procedure 3,704 53% Heart Conditions Statin Therapy for Beneficiaries with Coronary Artery Disease

1. Percentage Prescribed Statin Therapy 20,909 71% 2. Average Medication Possession Ratio* 20,172 80% 3. Percentage with Medication Possession Ratio ≥ 0.80* 20,172 64% Persistence of Beta Blocker Treatment After Heart Attack 10,381 57% Lipid Profile for Beneficiaries with Ischemic Vascular Disease 22,130 44% Human Immunodeficiency Virus (HIV) Monitoring for Disease Activity for Beneficiaries with HIV 13,345 39% Mental Health Antidepressant Treatment for Depression

1. Acute Phase Treatment (at least 12 weeks) 16,224 54% 2. Continuation Phase Treatment (at least 6 months) 16,224 39% Follow-Up After Hospitalization for Mental Illness

1. Percentage of Patients Receiving Follow-Up Within 30 Days 18,562 63% 2. Percentage of Patients Receiving Follow-Up Within 7 Days 18,562 33% Prevention Breast Cancer Screening for Women ≤ 69 23,021 64% Medication Management Viral Load Testing for Beneficiaries with Antiviral Therapy for Hepatitis C 1,212 93% Lipid Profile for Beneficiaries Who Started Lipid-Lowering Medications 22,632 41% Annual Monitoring for Beneficiaries on Persistent Medications

1. Angiotensin Converting Enzyme (ACE) Inhibitors or Angiotensin Receptor Blockers (ARB) 22,010 93% 2. Digoxin 15,167 93%CMS-1590-P 633

Mean Performance Rate Clinical Condition and Measure Physicians in Iowa, Kansas, Missouri, and Nebraska Specifications for these clinical measures are posted at http://www.cms.gov/PhysicianFeedbackProgram/Downloads /claims_based_measures_with_descriptions_num_denom_excl.pdf

. Number of Physicians Included Percentage of Medicare Patients Who

Received the Service 3. Diuretics 21,905 93% 4. Anticonvulsants 1,712 39% 5. Total Rate (sum of 4 previous numerators divided by sum of 4 previous denominators) 22,385 92% Anticoagulation Treatment ≥ 3 Months After D eep Vein Thrombosis 14,787 43% Anticoagulation Treatment ≥ 3 Months After Pulmonary Embolism 10,298 44% International Normalized Ratio (INR) Testing for Beneficiaries Taking Warfarin and Interacting Anti-Infective Medications 14,006 14% NOTE: For the measures shown below, lower percentages reflect better performance Drugs to Be Avoided for Beneficiaries ≥ 65

1. Patients Who Receive at L east One Drug to Be Avoided 23,085 27% 2. Patients Who Receive at Least Two Different Drugs to Be Avoided 23,085 16% Potentially Harmful Drug-Disease Interactions for Beneficiaries ≥ 65

1. Prescription for Tricyclic Antidepressa nts, Antipsychotics, or Sleep Agents for Patients with a History of Falls 21,132 18% 2. Prescription for Tricyclic Antidep ressants or Anticholinergic Agents for Patients with Dementia 21,443 29% 3. Prescription for Nonaspirin NSAIDs or Cox-2 Selective NSAIDs for Patients with Chronic Renal Failure 16,902 8% 4. Total Rate (sum of 3 previous numerators divided by sum of 3 previous denominators) 22,232 22% Lack of Monthly INR Monitoring for Beneficiaries on Warfarin 21,967 48% *Unlike the other measures in this table, these values represent a ratio, not a per centage of patients receiving the service. The reports also provided information on five measures of per capita cost. Total per capita costs for beneficiaries attributed to the physician and total per capita costs for

beneficiaries that had the follo wing four chronic conditions: di abetes; heart failure; chronic obstructive pulmonary disease (COPD); and coro nary artery disease (CAD). As discussed earlier, we standardized and risk adjusted the total per capita cost measures. To assess per capita cost measures, we attr ibuted beneficiaries to physicians. To attribute beneficiaries, the repor ts classified each physician’s Me dicare FFS beneficiaries into three groups based upon the degree of the phys ician’s involvement with the patient:

● Directed : The physician billed for 35 percent or more of the patient’s office or other outpatient Evaluation and Ma nagement (E&M) visits.CMS-1590-P 634

● Influenced : The physician billed for fewer than 35 percent of the patient’s outpatient E&M visits, but for 20 percent or more of the patient’s total professional costs.

● Contributed : The physician billed for fewer than 35 percent of the patient’s outpatient E&M visits, and for less than 20 percen t of the patient’s total professional costs.

As discussed with referen ce to the value-based payment modifier, this attribution methodology assigns the same patient to all physicians who treated the patien t, but classifies the patient based on how involved the physician was with the care provided to the patient.

Table 76 shows the number of beneficiaries attributed, on average, to physicians under each of these rules. We wish to highlight two obs ervations. First, that primary care physicians generally furnished services to fewer patients than surgeons/specialis ts and other types of physicians (which included radiologists, anesthes iologists, and patholog ists) and that primary care physicians directed care more often than ot her types of physicians. Second, there were several physicians in all categories who only c ontributed to care, meaning that care can frequently be fragmented. This finding highl ights the importance of coordinating care among physicians. TABLE 76: Beneficiaries in Iowa, Kansas , Missouri, and Nebraska Attributed by Physician Type: Average Number of Beneficiaries

Type of Physician Average Number of Attributed Beneficiaries Average Number of Directed Beneficiaries Average Number of Influenced Beneficiaries Average Number of Contributed Beneficiaries Primary care 279 105 13 181 Medical specialist 471 59 51 381 Surgeons 309 36 64 217 Emergency medicine 367 35 14 350

Other 860 18 34 840

We calculated total per capita co sts for each type of attributi on of patients. As discussedCMS-1590-P 635

above and shown in Table 77, the beneficiarie s who receive care under the “contributed only” attribution have substantially higher per capita cost s and accounted for 20 percent of those beneficiaries covered by th e 2010 individual reports. TABLE 77: Mean Total Per Capita Costs in the QRURs Type of Physician Overall Directed Influenced Contributed Primary care $16,580 $9,733 $6,780 $19,019 Medical specialist 19,765 11,256 9,219 21,276 Surgeons 17,535 11,482 15,182 18,313 Emergency medicine 20,729 10,389 3,675 21,217 Other 23,704 11,442 8,987 23,980 (c.) Physician Feedback Pr ogram Dissemination Strategy Based on our previous dissemination of indivi dual Physician Feedback reports, we have learned that the overwhelming f actor that prevents physicians from accessing their reports is lack of knowledge of their avai lability. We undertook several st eps this year to increase awareness of the Physician Feedback reports. Fi rst, we increased the information we provided to physicians about the feedback reports, performance reporting, the value-based payment modifier, and our methodology via www.cms.gov/physicianfeedbackprogram , fact sheets, FAQs, video, slides, national provider calls, targ eted conference calls w ith report recipients, meetings with national and local medical associations and specialties, and multiple physician

fee for service list serve announcements. We also partnered with the J5 Medicare Administrative Contractor (MAC), WPS, for Io wa, Kansas, Nebraska, and Missouri, to develop a secure internet portal where physician could ea sily obtain their reports . As of June 10, 2012, 7,484 of approximately 24,000 (31 percent) indivi dual Physician Feedback reports have been accessed electronically. This is a substantial increase from earlier phases of the Physician Feedback program in which only 1 percent of physicians obtained their reports.CMS-1590-P 636

We also have aggressively solicited f eedback from physicians and physician groups, including the American Medical As sociation, on how to increase th e usefulness of the reports so that physicians and groups of physicians would actively seek this type of information from CMS. We invited report recipients (via seve ral conference calls dire cted first to medical practice groups and then indivi dual physicians) to provide us input on the usefulness and credibility of the performance m easures, and other information cont ained in the reports so that we can improve the reports for future years. Following the September 26, 2011 distribution of reports to physician groups, we hosted two conference calls for the 35 large medical pr actice groups. In additi on to “walking through” a sample template of the group performance re port, we responded to questions and followed up with an aggregation of ques tions/issues raised by groups and corresponding answers and explanations from CMS. These reports represen t the first time performance on a wide-range of quality and cost measures can be viewed in the same report for Medicare beneficiaries in large group practices across the country.

After the March 2012 dissemination of i ndividual reports, we conducted National Provider Calls on April 3, 2012 and April 5, 201 2 at which time we reported some initial observations, reviewed a report template page by page, and answered que stions from the call participants. On May 8, 2012 and June 4, 2012, we held another call in conjunction with the MAC, WPS, to obtain targeted feedback on the feedback re ports and how they could be improved and made more useful. We view the physician feedback repo rts as a way to test various methods of analyzing and displayi ng comparative performance information and previewing methods that will be further developed for use in the value-based payment modifier. In addition, we have responded to over 50 reques ts for more information from the Help Desk we established for the program.CMS-1590-P 637

(d.) Future Plans for the Physician Feedback Reports In the fall of 2012, we plan to disseminate Physician Feedback reports to all physicians in nine states (California, Iowa, Illinois, Ka nsas, Michigan, Minnesota, Missouri, Nebraska, and Wisconsin) based on 2011 data. These reports w ill contain the PQRS measures that physicians in these states submitted via enhanced claims, 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 th at reported measures through the PQRS GPRO web interface in 2011. We have adjusted and improved the content and organization of the Physician Feedback reports that we plan to pr oduce later this year ba sed on the comments we received from the Program Year 2010 report reci pients. We plan to increase our outreach efforts to encourage physicians to view their reports, to begin to understand the methodologies we have proposed for the value-based paymen t modifier and that are included in the 2011 reports, and to provide suggesti ons on how we can make these reports more 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 phys icians with 25 or more eligible professionals and to individual physicians that satisfactorily reported measures through PQRS in 2012 using any of the PQRS reporting mechanisms. These reports will include a “first look” at the methodologies that we are proposing in this 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 episode types in these Physician Feedback reports. In addition, we plan to consider adjusting the format a nd organization of the reports, to the extentCMS-1590-P 638

practicable, to address the be st practices outlined in the AMA’s Guidelines for Reporting Physician Data. We believe that this dissemi nation plan satisfies our obligations under the section 1848(p)(4)(B)( ii)(II) of the Act to provide info rmation to physicians and groups of physicians about the quality of care furn ished 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. We are examining whet her we can provide reports to groups of physicians with fewer than 25 eligible professionals and to individual level reports as well. These reports will c ontain, among other things, perfor mance on the quality and cost measures used to score the composites and th e value-based payment modifier amount. As discussed above, we anticipate providing an opport unity for review and correction as outlined in our value-based payment modifier proposals above. 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 Weekly Report, which included an article entitled “Use of Hepatitis B Vaccination for Adults w ith Diabetes Mellitus: Recommendations of the Advisory Committee on Immunizati on Practices (ACIP).” The arti cle stated that “In the UnitedCMS-1590-P 639

States, since 1996, a total of 29 outbreaks of HBV [H epatitis B virus] infection in one or multiple long-term care (LTC) facilities, including nursing homes and assisted-liv ing facilities, were reported to CDC; of these, 25 involved adults with diabetes receivi ng assisted blood glucose monitoring. These outbreaks prompted the Hepa titis Vaccines Work Gr oup of the Advisory

Committee on Immunization 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 clinicianCMS-1590-P 640

to unvaccinated adults with diabetes mellitu s who are aged 60 years and older. b. Implementation Based on the ACIP recommendations, we pr opose 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 w ith blood that is not visible to th e unaided eye, we believe that persons diagnosed with diabetes mellitus should be added 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. Ther efore, we are proposing to expand coverage for hepatitis B vaccine and its admini stration to all individuals diagnos ed with diabetes mellitus, not just those individuals with diabetes that are receiving glucose monito ring in facilities, for example, in nursing homes. 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 XVIII of the Social Security Act (the Act) to establish a voluntary prescripti on drug benefit program at section 1860D-4(e) of the SocialCMS-1590-P 641

Security Act. Among other things, these provisions required the adoption of Part D e-prescribing standards. Prescription Drug Plan (PDP) spons ors and Medicare Advantage (MA) organizations offering Medicare Advantage-Prescription Drug Plans (MA-PD) are required to establish electronic prescription drug program s that comply with the e-prescribing standards that are adopted under this authority. There is no require ment that prescribers or dispensers implement e-prescribing. However, prescribers and dispen sers who electronically transmit prescription and certain other information for covered drugs prescrib ed for Medicare Part D eligible beneficiaries, directly or through an intermediar y, are required to comply with a ny applicable standards that are

in effect. For a further discussion of the statutory basi s for this proposed 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 e-prescribing program. Its first rule, which was published on November 7, 2005 (70 FR 67568), adopted three

standards that were collectivel y referred to as the “foundation” standards. One of these standards, the National Counc il for Prescription Drug Program s (NCPDP) SCRIPT Standard, Implementation Guide, Version 5, Release 0 (Version 5.0), May 12, 2004 (excluding the Prescription Fill Status Notification Transaction and its three business cases; Prescription Fill Status Notification Transaction--Filled, Prescrip tion Fill Status Notification Transaction--Not Filled, and Prescription Fill Status Notification Trans action--Partial Fill), hereafter referred to asCMS-1590-P 642

the NCPDP SCRIPT 5.0, is the subject of several of the proposals in this rule. CMS issued a subsequent rule on April 7, 2008 (73 FR 18918) th at adopted additional standards which are

referred to as “final” standards. One of thes e standards, version 1.0 of the NCPDP Formulary and Benefit standard, Implementa tion Guide, Version 1, Release 0, hereafter referred to as the NCPDP Formulary and Benefit 1.0) is also one of the subjects of this proposed rule. Please see

the “Initial Standards Versus Final Standards” discussion at 70 FR 67568 in the November 7,

2005 rule for a more detailed discussion a bout “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 intermed iary, are generally required to comply with any applicable

standards that are in effect at the time of their transmission, the early versions of the NCPDP SCRIPT standard did not support the complexities of the prescribing process for patients in long

term care facilities where the prescribing process involves not only a prescriber and a pharmacy, but also a facility and its sta ff. As such, we exempted such entities from use of the NCPDP SCRIPT standard. That exemption, curren tly 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-Prescribing Standards

Transaction standards are periodically updated to take new knowledge, technology and

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 processCMS-1590-P 643

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 modifi cation, however, 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 reference in the Federal Register. CMS utili zed this streamlined process when it 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 use of either of the two versions in the Pa rt 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 compa tible 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 standard. Finally, on July 1, 2010, CMS utili zed the streamlined process to recognize NCPDP SCRIPT 10.6 as a backward comp atible 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 place as the official Part D e-prescribing standard. 2. Proposals for Calendar Year 2013CMS-1590-P 644

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 greater detail below, we propose to finalize our recognition of NCPDP SCRIPT 10.6 as a backward compatible version of the official Part D e-prescribing standard NCPDP SCRIPT 8.1, effective from the effective date of the final rule through October 31, 2013, but, in response to the comments that were receiv ed to the interim final rule with comment, we also propose to retire NCPDP SCRIPT 8.1 eff ective October 31, 2013, and we propose to adopt NCPDP SCRIPT 10.6 as the official Part D e-pr escribing standard effective November 1, 2013. On July 1, 2010, we published an interim final rule with comment (75 FR 38026)

which named NCPDP SCRIPT 10.6 as a backward compatible update to NCPDP SCRIPT 8.1. We received 7 timely public comments on this in terim final rule with comment. The comments came from a standards setting orga nization, two national industry associations, two healthcare organizations and, two health information in termediaries. All commenters supported the voluntary use of NCPDP SCRIPT version 10.6 as a backward compatible version of the adopted

NCPDP SCRIPT 8.1 standard. Fi ve of the commenters reco mmended that Version 10.6 be adopted as the official standard for the Medi care Part D E-Prescribing Program with a time frame of full implementation of January 1, 2013. One commenter recommended that CMS adopt version 10.6 as the official Part D e-prescrib ing standard, and retire version 8.1, but did not suggest a date by which that should happen. Another commenter recommended that CMS adopt version 10.6 as early as January 1, 2012. All co mmenters agreed that version 8.1 should be retired when version 10.6 was adopted. As we discussed in the July 1, 2010 inte rim final rule with comment (75 FR 38026)

NCPDP SCRIPT 10.6 has a number of new functional ities that, if users el ect to use them willCMS-1590-P 645

mesh with their use of the adopted NCPDP SC RIPT 8.1, which was adopted in the April 7, 2008 e-prescribing final rule (73 FR 18918). These new functions would allow users drug NDC source information, pharmacy prescription fill numbers and da te of sale information that could then be used in a medication history response. These a dded functionalities would therefore be expected

to facilitate bette r record matching, the identification and elimination of duplicate records, and the provision of richer information to the pr escriber between willing trading partners. We therefore agree with commenters that NCPDP SCRIPT 10.6 would be appropriate as an official standard for the Medicare Part D e-Prescribing Program. At the time of this rule’s drafting, however, the suggested dates for the adoption of SCRIPT Version 10.6 as th e official Part D eprescribing standard and the reti rement of NCPDP SCRIPT 8.1 have either passed or are too near in the future to be a reasonable implementation date. Furthermore, since the time of these comments, industry stakeholders have work ed with NCPDP, a standards development organization, and reached out to CMS with additional suggestions for appropriate implementation dates in light of the current state of the standards development process. Stakeholders working though NCPDP currently recommend retiring NCPDP SCRIPT 8.1 on October 31, 2013 and adoption of NCPDP Script 10.6 as the official Pa rt D e-prescribing standard on November 1, 2013. We believe that th is is a realistic timetable to retire NCPDP SCRIPT 8.1 and the adopt NCPDP SCRIPT 10.6 as th e official Part D e-prescribing standard on

the dates described. As such, we propose 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 dispensers use NCPDP SCRIPT 10.6 for the following electronic transactions that convey prescr iption or prescription related information:

• Get message transaction.CMS-1590-P 646

• Status response transaction.

• Error response transaction.

• New prescription transaction.

• Prescription change request transaction.

• Prescription change response transaction.

• 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 propose to amend §423.160( b)(1) by adding a ne w 423.160(b)(1)(iii) to amend the information about which subsequent re quirements in the section are applicable to which timeframes and amend §423.160(b)(1)(ii) to limit its application to transactions on or before October 31, 2013. As considerable time has passed since we solicited comments on the retirement of NCPDP SCRIPT 8.1, we are soliciting additional co mments regarding the retirement of version 8.1 on October 31, 2013. We also are soliciting comments on the adoption of Version 10.6 as the official Part D e-prescribing standard for the e-prescribing functions that will be outlined in §423.160(b)(1)(iii) and (b)(2)(iii) , effective 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 ofCMS-1590-P 647

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. 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 upda ting 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 e-CMS-1590-P 648

prescribing 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 formulary 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: “Classifica tion 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 the 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,” The following has been clarified from “ The file load also enablesCMS-1590-P 649

payers to specify a single coverage-related 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 have reviewed Version 3.0, and based on our findings, we have determined that Formulary and Benefits 3.0 maintains full functio nality of the official adopted Part D eprescribing standard Formulary and Bene fits 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 elem ents of a final rule in one rule, we are electing this one time to formally propose recogn izing a subsequent standard as a backward compatible version of an adopted standard th rough full notice and comment rulemaking in order to avoid having to publish two rules contemporan eously. We therefore propose to recognize the use of either 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 w ithout modification. Therefore, as we are using full notice and comment in place of the backward compatible me thodology in this one instance, we also propose to require users of 3.0 to support users who are still using Versi on 1.0 until such time as Version 1.0 is officially retired as a Part D e-prescrib ing standard and Version 3.0 is adopted as the official Part D e-pres cribing standard.CMS-1590-P 650

To effectuate these proposals, we also propose to revise §423 .160(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 compatible version of the official Part D eprescribing standard [i from 60 days from th e publishing of the final rule through October 31, 2013 We seek comment on this proposal as well. . We also seek comment on timing and when to retire Version 1.0 as the official Part D eprescribing standard, and the proposal to adopt Formulary a nd Benefit Version 3.0. as the official Part D e-pres cribing standard. 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 theCMS-1590-P 651

official Part D e-prescr ibing standard and the removal of th e long-term care facility exemption

from the NCPDP SCIPT standard.

LTC enhancements were first made to the NCPDP SCRIPT version 10.2, and were subsequently further enhanced in subseque nt versions of the SCRIPT Standard. In a July 1, 2009 recommendation letter to the Secretary, ( http://www.ncvhs.hhs.gov/090701lt.pdf ) NCVHS recommended the adoption of Version 10.6,

the retirement of Version 8.1 a nd the lifting of the current ex emption at §423.160(a)(3)(iv) from the requirement to use the NCPDP SCRIPT standard for providers in long-term care settings. During the NCVHS testimony that preceded the r ecommendation letter, members of the industry testified that the changes that were presen t in NCPDP SCRIPT 10.6 cr eated an environment where long-term care (LTC) facilities could ca rry out e-prescribing using NCPDP SCRIPT 10.6 if it were to be adopted as the official Part D e-prescribing st andard. More information on the testimony given to, and the recommendations given by NCVHS, can be found at the NCVHS

Website http://www.ncvhs.hhs.gov/

. We considered the recommendations of the industry and NCVHS and concluded that it would be appropriate to retire Version 8.1, adopt Version 10.6 a nd eliminate the LTC exemption

from the NCPDP SCRIPT standard. Since the LTC industry currently is exempt from the requirement to use the NCPDP SCRIPT Version 8.1 standard, Medicare Part D e-prescribing operators, providers, and vendors have been utili zing proprietary e-prescribing solutions and

interfaces in the form of electronic medication administ ration records and internet communications, which are likely not interoperable. As the use of Part D e-prescribing standards would promote our administrative priorities of promoting interoperability and harmonization among IT systems, we therefore propose to reti re Version 8.1, adopt Version 10.6 and eliminate the current exemption at §423.160(a)(3)(iv) for entit ies transmitting prescriptions or prescription-CMS-1590-P 652

related information where the prescriber is require d by law to issue a prescription for a patient to a non-prescribing provider (such as a nursing facility ) that in turn forwards the prescription to a dispenser. We are soliciting comments on lifting th e Long Term Care exemption, effective November 1, 2013 in conjunction with the eff ective date of NCPDP SCRIPT 10.6. We solicit 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.CMS-1590-P 653

IV. Technical Corrections A. Waiver of Deductible for Surgical Servi ces Furnished on the Same Date as a Planned Screening Colorectal Cancer Test and Colo rectal Cancer Screening Test Definition. Section 4104(c) of the Affordable Care Ac t amended section 1833(b)(1) of the Act to

waive the Part B deductible for colorectal cancer screening tests that b ecome diagnostic in the course of the procedure or visit. Specifi cally, section 1833(b)(1) of the Act waives the deductible for colorectal screening tests regardless of the code that is billed for the establishment of a diagnosis as a result of the test, or the re moval of tissue or other matter or other procedure that is furnished in connection with, as a resu lt of, and in the same clinical encounter as a screening test. To implement this statutory pr ovision, we proposed that “all surgical services furnished on the same date as a planned scre ening colonoscopy, planned flexible sigmoidoscopy,

or barium enema be considered to be furnished in connection with, as a re sult of, and in the same clinical encounter as the screening test.” After receiving public comm ent, this proposal was

finalized in the CY 2011 final rule with commen t period (75 FR 73431). However, we neglected to amend our regulations to reflect this policy. When a screening test becomes a diagnostic service, practitione rs are to append a modifier to the diagnostic procedure code that is reported instead of the HCPCS code for screening colonoscopy or screening flexible sigmoi doscopy or as a result of the barium enema. By use of this modifier, practitioners signal that the procedure meets the criteria for the

deductible to be waived. To reflect this policy in our regulations, we propose to amend §410.160 Part B annual

deductible to include colorectal screening tests that become dia gnostic services in the list of

services for which the deductib le does not apply. Specifical ly, we propose to add a new §410.160(b)(8) to read, “Beginning January 1, 2011, a surgical service furnished on the sameCMS-1590-P 654

date as a planned colorectal cancer sc reening test 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. In order to conform our regulat ions to section 1861(pp)(1)(C) of the Act, we propose to modify §410.37(a)(1)( iii) to define “Screening colonoscopies” by removing the phrase “In the case of an individu al at high risk for colorectal cancer” from this paragraph. We also propose 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 propose to redesi gnate paragraphs (g)(2) through (g)(4) and make technical changes to newly redesignated paragra ph (g)(1) by replacing the reference to paragraph (g)(4) with a reference to newly re designated paragraph (g)(3).CMS-1590-P 655

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 co llection 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 collection 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. We are soliciting public comment on each of th ese issues for the following sections of this document that contain information collection requirements (ICRs): A. ICRs Regarding Diagnostic X-ray Tests, Di agnostic Laboratory Tests, and Other Diagnostic Tests: Conditions (§410.32) Proposed §410.32(d)(2)(i) woul d require that the physicia n or qualified nonphysician practitioner (as defined in §410.32(a)(2)) who orde rs the service mainta in documentation of medical necessity in the beneficiary’s medical re cord. In addition, both the medical record and the laboratory requisition (or or der) would be required to be signed by the physician or qualified nonphysician practitioner who orders the service. The burden associ ated with these requirements would be the time and effort necessary for a phys ician or qualified nonphysician practitioner to sign the medical record or laborat ory requisition (or order). There would also be a recordkeepingCMS-1590-P 656

requirement associated with maintaining th e documentation of medical necessity in the beneficiary medical record. While these requirements are subject to the PRA, we believe the associated burden is exempt from the PRA in accordance with 5 CFR 1320.3(b)(2). We believe that the time, effort, and fina ncial resources necessary to co mply with the aforementioned information collection requirement s would be incurred by persons in the normal course of their

activities and therefore cons idered to be usual and cu stomary business practices. B. ICRs Regarding Durable Medical Equipment Scope and Conditions (§410.38(g)) In §410.38(g), we would require (as a condition of payment for certain covered items of DME) that a physician must have documented an d communicated to the DME supplier that the physician or a physician assistant (PA), a nurse practitioner (NP), or a clinical nurse specialist (CNS) has had a face-to-face encount er with the beneficiary no more than 90 days before the order is written or within 30 days after the order is written. We propose that when the face-to-face en counter is performed by a physician, the submission of the pertinent porti on(s) of the beneficiary’s medi cal record (portions containing

sufficient information to document that the f ace-to-face encounter meets our requirements)

would be considered sufficient and valid doc umentation 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 addressed in this proposed rule are already conducting a needs assessment and evaluating or treating the beneficiary for condi tions relevant to the covered item of DME, this proposed rule may require some changes in their procedures to ensure that

their documentation fulfills Medi care's regulatory requirements. Suppliers should already be receiving written orders and documentation to su pport the appropriateness of certain items of

DME. To promote the authenticity a nd comprehensiveness of the wr itten order and as part ofCMS-1590-P 657

our efforts to reduce the risk of waste, fra ud, and abuse, we propose that as a condition of payment a written order must incl ude: (1) the beneficiaries’ na me; (2) the item of DME ordered; (3) prescribing practitioner NPI; (4) the signature of the prescribing practit ioner; (5) the date of the order; (6) the diagnosis; and (7) necessary proper usage instructions, as applicable.

In order to determine costs associated with the impact we utilized the Bureau of Labor Statistics mean hourly rates for the professional, an alyzed for the year that the original 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 overhead, for a NP, PA, CNS is estimated at $55 per hour. The hourly rate for admi nistrative assistant, in cluding 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. In order to allow paymen t for this documentation, a G code is established for this service. There are approximately 10 million DME users and it was assumed that roughly 5 percent of face-to-face encount ers are actually performed by these other provider types, thereby requiring documentation of the encounter. Therefore, it was assumed that about 500,000

of these documentation services w ould be billed. 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 700,000 million hours over 5 years. The associated cost in ye ar 1 is nearly $9.8 million and over 5 years has associated costs of nearly $82.6 million based on the growth rate of th e Medicare population. The increase is slightly more than five-fold because the number of Medicare beneficiaries would

increase over time.CMS-1590-P 658

TABLE 78: Physician Time to Document Occurrence of a Face-to-Face Encounter

Year 1 5 Years Number of claims affected 500,000 4,200,000 Time for physician review of each claim 10 min 10 min Total Time 83,333 hours 700,000 hours Estimated Total Cost (Hours times $118) $ 9,833,333 $ 82,600,000 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 210,000 hours over 5 years at a cost of nearly $11.6 milli on based on the growth rate of the Medicare population. Though consistent with previous estimates, we believe that using a PA, NP, or CNS hourly rate creates a high burden impact estimat e since most of these tasks would more than likely be completed by administrative personnel. We welcome comments on the appropriateness

of these estimates. TABLE 79: Physician Assistant, Nurse Prac titioner or Clinical Nurse Specialist Time

Year 1 5 Years Number of claims affected 500,000 4,200,000 Time for PAs, NPs, or CNSs to gather and provide each claim 3 min 3 min Total Time 25,000 hours 210,000 hours Estimated Total Cost (Hours times $55) $ 1,375,000.00 11,550,000

This proposed rule would create only a minima l change in the normal course of business activities in regards to reco rdkeeping. Although we believe the documentation of a needs assessment, evaluation, and or treatment of a bene ficiary for a condition relevant to an item of DME is a common practice, it is possible that some practitioners may not be documenting the results of all encounters; and therefore, there ma y be additional impact for some practitioners. This regulation requires that the supplier have access to the documentation of the face-toface encounter, which is required when CMS conduc ts an audit. CMS already accounts for theCMS-1590-P 659

audit burden associated with the exchange of documentation for claims subject to prepayment review (approved under OCN 0938-0969). As a bus iness practice we recognize that some suppliers may receive the documentation of the f ace-to-face for all applicable claims, voluntarily. We believe that the requirements expressed in this proposed rule meet the utility and clarity standards. We welcome comment on this assumption and on ways to minimize the burden on affected parties. The proposed r ecordkeeping requirement in §410.38(g)(5) and the requirement to maintain and make the supplie r’s order/additional docum entation available to CMS upon request is subject to the PRA, but we believe that these requirements are usual and customary business practices as defined in 5 CFR 1320.3(b)(2) and, therefore, the associated burden is exempt from the PRA. C. ICRs Regarding Physician Quality Reporting System – Definitions (§414.90(b)) While §414.90(b) contains information collectio n requirements regarding the input process

and the endorsement of consensus- based quality measures, this rule would not revise any of the information collection requirements or burden estimates that are associated with those provisions. All of the requi rements and burden estimates ar e currently approved by OMB under OCN 0938-1083, 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. ). D. ICRs Regarding Physician Quality Reporti ng System – Use of Consensus-based Quality Measures (§ 414.90(e)) We are proposing to revise §414.90(e), redesigna ted as to broadly define our use of consensus-based quality measures. The curren t regulation at §414.90(e) states that we will publish a final list of measures every year. However, we are proposing measures for 2013 and beyond this year . While §414.90(e) contains information collectio n requirements regarding the input processCMS-1590-P 660

and the endorsement of consensus- based quality measures, this rule would not revise any of the information collection requirements or burden estimates that are associated with those provisions. All of the requi rements and burden estimates ar e currently approved by OMB under OCN 0938-1083, 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.). E. ICRs Regarding Physician Quality Repor ting System – Requirements for the Incentive Payments (§ 414.90(g)) While §414.90(g) contains information colle ction requirements regarding the PQRS incentive payments, this rule would not revise any of the information co llection requirements or

burden estimates that are associated with those provisions. 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. ). F. 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 would not revise any of the information collection requirements

or burden estimates that are associated with thos e provisions, except for the proposed criteria for reporting via claims for the 2015 and 2016 PQRS pa yment adjustments and the provisions that would allow the administrative claims reporting op tion. 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. ). With respect to the proposed reporting criteria for the 2015 and 2016 PQRS paymentCMS-1590-P 661

adjustments using the claims-based reporting mechan ism, we note below that we anticipate that approximately 320,000 eligible professionals woul d use the claims-based reporting mechanism

for CYs 2013 and 2014. This is a difference of 120,000 from the 200,000 that participated in PQRS using the claims-based reporting mech anism in 2010. We believe that these 120,000 eligible professional would us e the 2015 and 2016 PQRS payment adjustment claims-based payment adjustment criteria to meet the cr iteria for satisfactory reporting for the 2015 and 2016 payment adjustments. We estimate the cost for an eligible professi onal and group practices to review the list of PQRS quality measures or measures group, identify the applicable measures or measures group for which they can report the necessary inform ation, incorporate reporting of the selected measures or measures group into the office work flows, and select a PQRS reporting option to be approximately $200 per eligible professional ($40 per hour x 5 hours). Based on our experience with the Physician Voluntary Reporting Program PVRP, we continue to estimate that the time needed to perform all the steps necessary to re port each measure (that is, reporting the relevant quality data code(s) for a measure) on claims will ranges from 15 seconds (0.25 minutes) to over 12 minutes for complicated cases and/or measures , with the median time being 1.75 minutes. At an average labor cost of $40/hour per practice, the cost associated with this burden would range from $0.17 in labor to about $8.00 in labor time fo r more complicated cases and/or measures,

with the cost for the medi an practice being $1.67.

The total estimated annual burden for this re quirement will also vary along with the volume of claims on which quality data is report ed. In previous years, when we required reporting on 80 percent of eligible cases for cl aims-based reporting, we found that on average, the median number of reporting instances for each of the PQRS measures was 9. Since we are proposing to reduce the required repo rting rate by over one-third to 50 percent, then for purposesCMS-1590-P 662

of this burden analysis we will assume that an e ligible professional or eligible professional in a group practice will need to report each selected measure for 6 reporting instances. The actual number of cases on which an eligible professiona l or group practice is required to report quality measures data will vary, however, with the elig ible professional's or group practice’s patient population and the types of meas ures on which the eligible professional or group practice chooses to report (each measure's specifications includes a required reporting frequency). Based on the assumptions discussed previously, we estimate the total annual reporting burden per individual eligible professional or eligible professional in a group pr actice associated with claims-based reporting would range from 4.5 minut es (0.25 minutes per measure x 3 measures x 6 cases per measure) to 180 minutes (12 minut es per measure x 3 measures x 6 cases per measure), with the burden to the median prac tice being 31.5 minutes (1.75 minutes per measure x 3 measures x 6 cases). We es timate the total annual re porting cost per elig ible professional or eligible professional in a group practice associat ed with claims-based reporting would range from $3.06 ($0.17 per measure x 3 measures x 6 cases per measure) to $144.00 ($8.00 per measure x 3 measures x 6 cases per measure), w ith the cost to the median practice being $30.06 per eligible professional ($1.67 per measure x 3 measures x 6 cases per measure). With respect to reporting using the admini strative claims reporting option, we estimate that the burden associated with reporting using th e administrative claims option is the time and effort associated with reporting. We note that the burden for eligible professionals and group practices using the administrative claims-based reporting mechanism G. Summary of Annual Burden Estimate s for Codified Requirements (Proposed) TABLE 80: Summary of Annual Burden Estimates Regulation

section(s) OCN Respondents Responses Burden per response (hr) Total burden (hr) 410.38(g) re: Physician 0938-New 500,000 500,000 10 min 83,333CMS-1590-P 663

410.38(g) re: PA, NP, or CNS 0938-New 500,000 500,000 3 min 25,000

414.90(h) 0938-1083 120,000 120,000 (120,000 responses x 1 measure) 0.5 (31.5 minutes – the median) 60,000

H. Additional Information Collection Requirements While this proposed rule would impose coll ection of information requirements that are set out in the regulatory text (see above), this rule also sets out information collection requirements that are set out onl y in the preamble. Following is a discussion of the preamblespecific information collections, some of wh ich have already received OMB approval. 1. Part B Drug Payment The discussion of average sales price (ASP) i ssues in section XXX of this proposed rule does not contain any new information collecti on requirements with respect to payment for Medicare Part B drugs and biologicals unde r the ASP methodology. Drug manufacturers are required to submit ASP data to us on a quarterly basis. The ASP repor ting requirements are set forth in section 1927(b) of the Ac t. The burden associated with this requirement is the time and effort required by manufacturers of Medicare Part B drugs and biol ogicals to calculate, record, and submit the required data to CMS. All of th e requirements and burden estimates are currently approved by OMB under OCN 0938-0921, and are not subject to additional OMB review under the authority of the Paperwork Reduction Act of 1995 (44 U.S.C. 3501 et seq. ). 2. Physician Quality Reporting System (PQRS) The preamble of this proposed rule disc usses the background of the PQRS, provides information about the proposed measures and repor ting mechanisms that would be available to eligible professionals and gr oup practices who choose to participate in the 2013 and 2014 PQRS, and provides the proposed criteria for satisf actory reporting in CYs 2013 and 2014 (for the 2013CMS-1590-P 664

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 incentive (i.e., 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 expect 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. Therefor e, we estimate that we would distribute approximately $162 million ($539 x 300,000 eligible professionals) and $216 million ($539 x 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.CMS-1590-P 665

We note that the total burden associated with participating in PQRS is the time and effort associated with indicating intent to particip ate in PQRS, if applicable, and submitting PQRS quality measures data. When establishing thes e burden estimates, we assume the following:

● The requirements for reporting for PQRS 2013 and 2014 incentives and 2015 and 2016 payment adjustments would be establishe d as proposed in this 2013 Medicare PFS proposed rule.

● For an eligible professional or group pract ice using the claims, re gistry, or EHR-based reporting mechanisms, that the eligible prof essional or group practice 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 the CY s 2013 and 2014 PQRS – New Individual Eligible Professionals: Preparation For an eligible professional who wishes to participate in PQRS as an individual, the eligible professional need not indicate his/her in tent to participate. Instead, the eligible professional may simply begin re porting quality measures data . Therefore, these burden estimates for individual eligible professionals participating in PQRS are based on the reporting mechanism the individual eligible professional ch ooses. However, we believe a new eligible professional or group practice would spend 5 hour s—which includes 2 hours to review PQRS measures list, review the various reporting optio ns, and select a reporting option and measures on which to report and 3 hours to review the meas ure specifications and develop a mechanism forCMS-1590-P 666

incorporating reporting of the sele cted measures into their office work flows. Therefore, we

believe that the initial administrative costs asso ciated with participa ting in PQRS would be approximately $80 ($16/hour x 5 hours). c. Burden Estimate on Participation in the 2013 and 2014 PQRS via the Claims-based Reporting Mechanism – Individual Eligible Professionals 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 CYs 2013 and 2014, we an ticipate that the per centage 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, although we estim ate that the participa tion rate for PQRS will double from participation rates in 2010, we note that, although we believe the claims-based reporting mechanism will be the most widely used, the percentage of PQRS 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 estimate that approximately 320,000 eligible pr ofessionals, whether part icipating individually or in a group practice, will pa rticipate in PQRS in CY 2014. With respect to an eligible pr ofessional who participates in PQRS via claims, the eligible professional must gather the re quired information, select the appropriate quality data codes (QDCs), and include the appropria te QDCs on the claims they submit for payment. PQRS will collect QDCs as additional (optional) line items on the existing HIPAA transaction 837-P and/or CMS Form 1500 (OCN 0938-0999). Based on our experience with Physician Voluntary Reporting Program PVRP, we continue to estimate that the time needed to perform all the stepsCMS-1590-P 667

necessary to report each measure via claims would range from 0.25 minutes to 12 minutes, depending on the complexity of the measure. 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 estimate that time cost of reporting for an elig ible professional via claims will range from $0.50 (0.75 minutes x $40/hour) to $24.00 (36 minutes x $40/hou r) per reported case. With respect to how many cases an eligible pr ofessional would report when us ing the claims-based reporting mechanism, we proposed that an eligible professional would need to report on 50 percent of the eligible professional’s applicable cases. Th e actual number of cases on which an eligible professional will report will vary depending on the number of the eligible professional’s applicable cases. However, in prior years, when the reporting thresh old was 80 percent, we found that the median number of reporting cases for each measure was 9. Since we are proposing to reduce the reporting threshold to 50 pe rcent, we estimate that the average number of reporting cases for each measure would be reduced to 6. Based on these estimates, we estimate 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. We note that, for the 2015 and 2016 PQRS payment adjustments, we are proposing 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 fo r to participate in PQRS as an administrative claims reporter.CMS-1590-P 668

Therefore, we estimate that the cost of under going the GPRO selection process will be ($16/hour x 2 hours) $32. With respect to reporting, we note that any bu rden associated with reporting would be negligible, as an eligib le professional or group practice w ould not be required to attach reporting G-codes on the claims they submit. Rather, CMS would bear the burden of reporting with respect to selecting which measures to report. We note that there would be no additional burden on the eligible professional or group prac tice to submit these claims, as the eligible professional or group practice would have alr eady 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 will remain the same, as eligible profe ssionals 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 professionals (or >1 percent) of e ligible professionals used the EHR-based reporting mechanism. We be lieve the number of elig ible professionals and group practices using the EHR-based reporting mechan ism will increase as el igible professionals become more familiar with EHR products. In part icular, we believe eligible professionals and group practices will transition from using th e claims-based to the EHR-based reporting mechanisms. We estimate that approximately 40,000 eligible professionals (4 percent), whether participating as an individual or part of a group practice, will use the EHR-based reporting

mechanism in CY 2014.CMS-1590-P 669

With respect to an eligible professional or group practice wh o participates 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 submits the quality measures data for the eligible professional. While we note that there may be start-up costs associated with purchasing a qualified registry, di rect 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 pro duct solely for the purpose of reporting PQRS quality measures. Therefore, we have not incl uded the cost of purchas ing a qualified registry, direct EHR, or EHR data submission ve ndor 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 note that we are proposing that eligible professiona ls choosing to participate as part of a group practice under the

GPRO would need to indicate thei r intent to participate in PQRS as a GPRO. The total burden for group practices who submit PQRS quality measur es data via the GPRO web-interface would be the time and effort associated with submitting 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. W ith respect to the administrative duties for being selected to participate in PQRS as a GPRO, we believe it would take approximate ly 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. Theref ore, we estimate that the cost of undergoing the GPRO selection process w ill be ($16/hour x 6 hours) $96.CMS-1590-P 670

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, completed th e data collection interf ace). Based on burden estimates for the PGP demonstration, which uses the same data submission methods, we estimate the burden associated with a group practice comp leting the data collectio n interface would be approximately 79 hours. Therefore, we estimate that the report cost for a group practice to submit PQRS quality measures data for an appl icable year would be ($40/hour x 79 hours) $3,160. Eligible professionals who wi sh to qualify for an additiona l 0.5 percent Maintenance of Certification Program incentive will need to “more frequently” than is required to qualify for or maintain board certification status participate in a qualified Maintenance of Certification Program for 2012 and successfully complete a qua lified Maintenance of Certification Program practice assessment for the applicable year. Although we understand that there is a cost associated with participating in a Maintenance of Certification Board, we believe that most of the eligible professionals attempting to earn this a dditional incentive would al ready 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 will 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 spends to complete the pract ice assessment component of the Maintenance of Certification ranges from 8-12 hours.CMS-1590-P 671

f. Burden Estimate on Vendor Partic ipation in the CYs 2013 and 2014 PQRS Aside from the burden of eligible profe ssionals and group practic es 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 estimate th at approximately 50 additi onal 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 submit PQRS quality measures data would be the time and effort associated with submitting this data. To submit quality measures data for the proposed PQRS program years, a registry 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 quali fication process, we estimate that it would take a total of 10 hours – including 1 hour to complete the self-nomination statement, 2 hours to interview with CMS, 2 hours to calculate numer ators, denominators, and measure results for each measure the registry wishes 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 estimate that it would cost a registry approximately ($16.00/hour x 10 hours) $160 to become qualified to submit PQRS quality measures data on behalf of its el igible 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 associatedCMS-1590-P 672

with reporting PQRS quality measures data. Wh ether there is any addi tional reporting burden will vary with each registry, depending on the re gistry’s level of savvy 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 meas ures data will be the time and effort associated with submitting this data. To subm it quality measures data for the proposed PQRS program years, 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 since we are proposing not to continue to require direct EHR products and EHR data submission vendors to become qualified to submit PQRS quality measures data, there is no burden associated with qualification of direct EHR products and EHR data submission vendor products. With respect to reporting quality measures data , we believe the burden asso ciated with the EHR vendor programming its EHR product(s) to extract the clini cal data that the eligib le professional would need to submit to CMS will depend on the vendo r’s familiarity with PQRS and the vendor’s system and programming capabilities. Since we believe that an EHR vendor would be submitting data for reasons other than reporti ng 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 81: 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 MinimalCMS-1590-P 673

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 82: Estimated Costs to Ve ndors to Participate in PQRS Estimated Hours Hourly Rate Total Cost Registry: Self-Nomination 10 $160 $160 EHR: Programming 0 $0 0

3. Electronic Prescribing (eRx) Incentive Program The requirements for the eRx Incentive Program for 2012—2014 were established in the CY 2012 Medicare PFS final rule. Although we are making proposals related to the eRx Incentive Program in the CY 2013 Medicare PFS, th ese proposals have no additional burden or impact on the public. Therefore, this rule would not revise the requirements or burden estimates approved by OMB under OCN: 0938-1083. 4. Physician Quality Reporting System-Medicare EHR Incentive Pilot The Physician Quality Reporting System-Medic are EHR Incentive Pilo t is a Pilot that provides a method whereby an eligible professi onal participating in bot h PQRS and Medicare EHR Incentive Program may submit one set of da ta and satisfy the reporting requirements for both programs. We believe any burden or impact a ssociated with the Pilot would be absorbed in the burden and impact estimates provided fo r PQRS (OCN: 0938-1083) and the EHR Incentive Program.

I. Submission of PRA-Related Comments If you comment on these information collecti on and recordkeeping requirements, please do either of the following: 1. Submit your comments electronically as sp ecified in the ADDRESSES section of this proposed rule; orCMS-1590-P 674

2. Submit your comments to the Office of Info rmation and Regulatory Affairs, Office of Management and Budget,

Attention: CMS Desk Officer, [CMS-1590-P] Fax: (202) 395-6974; or Email: OIRA_submission@omb.eop.gov

. VI. 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 will consider all comments we receive by the date and time specified in the “DATES” section of this preamble, and, when we proceed with a subse quent document, we will respond to the comments in the preamble to that document.CMS-1590-P 675

VII. Regulatory Impact Analysis

A. Statement of Need This proposed rule is necessary in order to make payment and policy changes under the Medicare PFS and to make required statutor y changes under the Middle Class Tax Relief and Job Creation Act of 2012 (MCTRJCA), the Affordab le Care Act, and othe r statutory changes. This proposed rule also is neces sary to make changes to Part B drug payment policy and other related 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 measured 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 RFACMS-1590-P 676

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 http://www.sba.gov/content/table- small-business-size-standards (refer to the 620000 series)). Individuals and States are not included in the definition of a small entity. 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 the rule affects, and an explanation of any meaningful op tions that achieve the objectives with less significant adverse economic 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 603 of the RFA. For purposes of section 1102(b) of the Act, we define a small rural hospital as a hospital that is located outsideCMS-1590-P 677

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 sector 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 proposed rule would have no consequentia l spending effect on Stat e, 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 proposed rule ; details the costs and benefits of the rule; analyzes alternatives; and presents the measur es we would use to minimize the burden on small

entities. As indicated elsewher e in this proposed rule, we are proposing to implement a variety of changes to our regulations, payments, or paym ent policies to ensure that our payment systems reflect changes in medical practice and the relativ e value of services, and to implement statutory provisions. We provide information for each of the policy changes in the relevant sections of this proposed rule. We are unaware of any rele vant Federal rules that duplicate, overlap, orCMS-1590-P 678

conflict with this proposed rule. The relevant sections of this proposed rule cont ain a description of significant 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 may 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 reve nues for PFS services compare payment rates for CY 2012 with proposed payment rates for CY 2013 using CY 2011 Medi care utilization as the basis for the comparison. To the extent that there are year-to-year ch anges in the volume and mix of services furnished by physicians, the actu al impact on total Medicare revenues will be

different from those shown in Tables 83 (CY 2013 PFS Proposed Rule Estimated Impact on Total Allowed Charges by Specialty ) and 84 (CY 2013 PFS Proposed Rule Estimated Impact on Total Allowed Charges by Special ty by Selected Proposal). The payment impacts reflect averages for each specialty based on Medicare uti lization. The payment impact for an individual physician would be different from the average and would depend on the mix of services the physician furnishes. The average change in total revenues would be less than the impact displayed here because physicians furnish serv ices to both Medicare and non-Medicare patients and specialties may receive substantial Medicare re venues for services that are not paid under the PFS. For instance, independent la boratories receive approximately 85 percent of their Medicare revenues from clinical laboratory services that are not paid under the PFS. Tables 83 and 84 show the payment impact on PFS services. We note that these impacts do not include the effect of the January 2013 conv ersion factor changes under current law. TheCMS-1590-P 679

annual update to the PFS conversion factor is ca lculated based on a statutory formula that measures actual versus allowed or “target” expe nditures, and applies a sustainable growth rate (SGR) calculation intended to control growth inaggregate Medicare expenditures for physicians’ services. This update methodology is typically referred to as the “SGR” 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 expend itures 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 a llowed expenditures, the update is reduced. If actual expenditures are less than allowed expe nditures, the update is increased. By law, we are required to appl y these updates in accordan ce with section 1848(d) and (f) of the Act, and any ne gative updates can only be averted by an Act of the Congress. While the Congress has provided temporary relief from negativ e updates for every year since 2003, a long-term solution is critical. We ar e committed to working with the Congress to permanently reform the SGR methodology for Me dicare PFS updates. We provide our most recent estimate of the SGR and physician update for CY 2013 on our website athttp://www.cms.gov/Medicare/Medicare-Fee-for-ServicePayment/SustainableGRatesConFact/index.htm l?redirect=/SustainableGRatesConFact/

. The following is an explanation of the in formation represented in Table 83:

● 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 servicesCMS-1590-P 680

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.

● 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 83: CY 2013 PFS Proposed Rule 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 $ 86,000 0% 0% 0% 01-ALLERGY/ IMMUNOLOGY $ 198 -1% 1% 0% 02-ANESTHESIOLOGY $ 1,970 -1% -3% -3% 03-CARDIAC SURGERY $ 366 -1% -2% -2% 04-CARDIOLOGY $ 6,568 -1% -2% -3% 05-COLON AND RECTAL SURGERY $ 153 -1% 1% 1% 06-CRITICAL CARE $ 261 -1% 0% 0% 07-DERMATOLOGY $ 3,008 -1% 0% 0% 08-EMERGENCY MEDICINE $ 2,819 -1% 0% -1% 09-ENDOCRINOLOGY $ 434 -1% 1% 1% 10-FAMILY PRACTICE $ 5,879 3% 4% 7% 11-GASTROENTEROLOGY $ 1,885 -1% 0% 0% 12-GENERAL PRACTICE $ 579 -1% 1% 0% 13-GENERAL SURGERY $ 2,261 -1% 0% 0% 14-GERIATRICS $ 217 1% 3% 4% 15-HAND SURGERY $ 134 -1% 0% 0% 16-HEMATOLOGY/ ONCOLOGY $ 1,900 -1% 0% -1% 17-INFECTIOUS DISEASE $ 623 -1% 1% 0% 18-INTERNAL MEDICINE $ 11,058 2% 3% 5% 19-INTERVENTIONAL PAIN MGMT $ 534 -1% 0% -1% 20-INTERVENTIONAL RADIOLOGY $ 203 -1% -2% -3% 21-MULTISPECIALTY CLINIC/OTHER PHY $ 202 -1% -1% -1% 22-NEPHROLOGY $ 2,065 -1% 0% -1%CMS-1590-P 681

(A) (B) (C) (D) (E) Specialty Allowed Charges

(mil) Impact of Work and MP RVU Changes Impact of PE RVU Changes Combined Impact

23-NEUROLOGY $ 1,601 -1% 2% 1% 24-NEUROSURGERY $ 681 -1% 0% -1% 25-NUCLEAR MEDICINE $ 49 -1% -3% -3% 27-OBSTETRICS/ GYNECOLOGY $ 698 -1% 0% 1% 28-OPHTHALMOLOGY $ 5,621 -1% 1% 1% 29-ORTHOPEDIC SURGERY $ 3,622 -1% 0% -1% 30-OTOLARNGOLOGY $ 1,070 -1% 1% 0% 31-PATHOLOGY $ 1,185 -1% -1% -2% 32-PEDIATRICS $ 64 2% 3% 5% 33-PHYSICAL MEDICINE $ 990 -1% 1% 1% 34-PLASTIC SURGERY $ 351 -1% 0% 0% 35-PSYCHIATRY $ 1,149 -1% 0% 0% 36-PULMONARY DISEASE $ 1,691 -1% 1% 0% 37-RADIATION ONCOLOGY $ 1,983 -1% -14% -14% 38-RADIOLOGY $ 4,791 -1% -3% -4% 39-RHEUMATOLOGY $ 545 -1% 0% 0% 40-THORACIC SURGERY $ 340 -1% -1% -2% 41-UROLOGY $ 1,909 -1% -1% -2% 42-VASCULAR SURGERY $ 882 -1% -2% -3% 43-AUDIOLOGIST $ 57 -1% -4% -5% 44-CHIROPRACTOR $ 738 -1% 1% 1% 45-CLINICAL PSYCHOLOGIST $ 567 -1% -2% -3% 46-CLINICAL SOCIAL WORKER $ 400 -1% -2% -3% 47-DIAGNOSTIC TESTING FACILITY $ 875 -1% -7% -8% 48-INDEPENDENT LABORATORY $ 1,064 -1% -1% -1% 49-NURSE ANES / ANES ASST $ 1,142 -1% -3% -4% 50-NURSE PRACTITIONER $ 1,606 1% 3% 5% 51-OPTOMETRY $ 1,048 -1% 2% 1% 52-ORAL/MAXILLOFACIAL SURGERY $ 44 -1% 1% 0% 53-PHYSICAL/OCCUPATIONAL THERAPY $ 2,613 -1% 3% 3% 54-PHYSICIAN ASSISTANT $ 1,219 1% 2% 3% 55-PODIATRY $ 1,898 -1% 2% 1% 56-PORTABLE X-RAY SUPPLIER $ 104 -1% 2% 2% 57-RADIATION THERAPY CENTERS $ 71 -1% -18% -19% 98-OTHER $ 19 -1% 1% 0% * 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. Table 84 shows the estimated impact of se lected policy proposals on total allowed charges, by specialty. The following is an ex planation of the information represented in

Table 84:

● Column A (Specialty) : The Medicare specialty code as reflected in ourCMS-1590-P 682

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 Baseline (PPIS tran sition, Updated Claims Data, and All Other Factors)) : This column shows the estimated CY 2 013 impact on total allowed charges of the changes in the RVUs due to the final year of the PPIS transition, proposed multiple procedure payment reduction for the TC of cardiovascular and ophthalmology diagnostic tests furnished on the same day (section II.B.4. of this proposed ru le), all other proposals that result in minimal redistribution of payments under the PFS, the us e of CY 2011 claims data to model payment rates, and other factors.

● Column D (Updated Equipment Interest Rate Assumption) : This column shows the estimated CY 2013 impact on total allowed charge s of the changes in the RVUs resulting from our proposed update to the equipment interest rate assumption as discussed in section II.A.2.f. of this proposed rule.

● Column E (Primary Care and Care Coordi nation: Post - Discharge Transitional Care Management Services): This column shows the estimated CY 2013 combined impact on total allowed charges of the changes in the RVUs re sulting from our proposed policy to pay for postdischarge transitional care manage ment services in the 30 days following an inpatient hospital, outpatient observation or partia l hospitalization, skilled nursing facility (SNF), or community mental health center (CMHC) discharge as discusse d in section II.H.1. of this proposed rule. WeCMS-1590-P 683

would expect a negative impact on all non-primary care specialties due to the application of a BN adjustment to reflect the discha rge transitional care management policy.

● Column F (Input Changes for Cert ain 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 proposal to revise the procedure times for certain radiation therapy procedures discussed in secti on II.B.3.b. of this proposed rule.

● Column G (Cumulative Impact): This column shows the estimated CY 2013 combined impact on total allowed charges of all the proposed changes in the previous columns.

TABLE 84: CY 2013 PFS Proposed Rule Estimated Impact on Total Allowed Charges by Specialty by Selected Proposal* (A) (B) (C) (D) (E) (F) (G)

Specialty Allowed Charges

(mil) Baseline (PPIS transition, new utilization and other

factors) Updated Equipment

Interest

Rate Assumption Discharge Transition CareManagement Input Changes for Certain Radiation Therapy Procedures Total (Cumulative

Impact)

TOTAL $ 85,485 0% 0% 0% 0% 0% 01-ALLERGY/ IMMUNOLOGY $ 198 0% 1% -2% 1% 0% 02-ANESTHESIOLOGY $ 1,969 -2% 0% -1% 0% -3% 03-CARDIAC SURGERY $ 366 -1% 0% -1% 0% -2% 04-CARDIOLOGY $ 6,565 -1% 0% -1% 0% -3% 05-COLON AND RECTAL SURGERY $ 153 1% 0% -1% 0% 1%

06-CRITICAL CARE $ 261 1% 0% -1% 0% 0% 07-DERMATOLOGY $ 3,008 0% 1% -2% 0% -1% 08-EMERGENCY MEDICINE $ 2,819 0% 0% -1% 0% -1% 09-ENDOCRINOLOGY $ 434 1% 0% -1% 0% 0% 10-FAMILY PRACTICE $ 5,872 2% 0% 5% 0% 7% 11-GASTROENTEROLOGY $ 1,885 1% 0% -1% 0% 0% 12-GENERAL PRACTICE $ 577 1% 0% -1% 0% 0% 13-GENERAL SURGERY $ 2,261 1% 0% -1% 0% 0% 14-GERIATRICS $ 217 2% 0% 2% 0% 4% 15-HAND SURGERY $ 134 1% 0% -1% 0% 0% 16-HEMATOLOGY/ ONCOLOGY $ 1,891 0% 1% -2% 0% -1% 17-INFECTIOUS DISEASE $ 623 2% 0% -1% 0% 1% 18-INTERNAL MEDICINE $ 11,049 1% 0% 3% 0% 5% 19-INTERVENTIONAL PAIN MGMT $ 533 0% 0% -1% 0% -1%CMS-1590-P 684

(A) (B) (C) (D) (E) (F) (G)

Specialty Allowed Charges

(mil) Baseline (PPIS transition, new utilization and other

factors) Updated Equipment

Interest

Rate Assumption Discharge Transition CareManagement Input Changes for Certain Radiation Therapy Procedures Total (Cumulative

Impact)

20-INTERVENTIONAL RADIOLOGY $ 202 -2% 0% -1% 0% -3%

21-MULTISPECIALTY CLINIC/OTHER PHY $ 201 -1% 0% -1% 0% -2% 22-NEPHROLOGY $ 2,064 0% 0% -1% 0% -1% 23-NEUROLOGY $ 1,596 2% 0% -1% 0% 1% 24-NEUROSURGERY $ 680 0% 0% -1% 0% -1% 25-NUCLEAR MEDICINE $ 48 -2% -1% -1% 0% -4% 27-OBSTETRICS/ GYNECOLOGY $ 698 1% 0% -1% 0% 0% 28-OPHTHALMOLOGY $ 5,621 2% 0% -1% 0% 1% 29-ORTHOPEDIC SURGERY $ 3,609 0% 0% -1% 0% -1% 30-OTOLARNGOLOGY $ 1,069 1% 1% -1% 0% 0% 31-PATHOLOGY $ 1,185 -1% 0% -1% 0% -2% 32-PEDIATRICS $ 64 1% 0% 3% 0% 5% 33-PHYSICAL MEDICINE $ 980 2% 0% -1% 0% 1% 34-PLASTIC SURGERY $ 351 1% 0% -1% 0% 0% 35-PSYCHIATRY $ 1,149 1% 0% -1% 0% 0% 36-PULMONARY DISEASE $ 1,691 1% 0% -1% 0% 0% 37-RADIATION ONCOLOGY $ 1,982 -3% -3% -2% -7% -15% 38-RADIOLOGY $ 4,724 -2% -1% -1% 0% -4% 39-RHEUMATOLOGY $ 544 0% 1% -2% 0% 0% 40-THORACIC SURGERY $ 340 -1% 0% -1% 0% -2% 41-UROLOGY $ 1,905 -1% 0% -1% 0% -2% 42-VASCULAR SURGERY $ 881 -2% 0% -1% 0% -3% 43-AUDIOLOGIST $ 57 -3% 0% -1% 0% -5% 44-CHIROPRACTOR $ 738 2% 0% -1% 0% 0% 45-CLINICAL PSYCHOLOGIST $ 567 -2% 0% -1% 0% -3% 46-CLINICAL SOCIAL WORKER $ 400 -2% 0% -1% 0% -3% 47-DIAGNOSTIC TESTING FACILITY $ 848 -5% -2% -2% 1% -8%

48-INDEPENDENT LABORATORY $ 1,064 -2% 1% -2% 1% -2% 49-NURSE ANES / ANES ASST $ 1,142 -3% 0% -1% 0% -4% 50-NURSE PRACTITIONER $ 1,606 2% 0% 3% 0% 5% 51-OPTOMETRY $ 1,048 2% 0% -1% 0% 1% 52-ORAL/MAXILLOFACIAL SURGERY $ 44 1% 1% -1% 0% 0%

53-PHYSICAL/OCCUPATIONAL THERAPY $ 2,263 3% 0% -1% 0% 3% 54-PHYSICIAN ASSISTANT $ 1,219 1% 0% 2% 0% 3% 55-PODIATRY $ 1,897 2% 1% -2% 0% 1% 56-PORTABLE X-RAY $ 104 2% 1% -2% 1% 2%CMS-1590-P 685

(A) (B) (C) (D) (E) (F) (G)

Specialty Allowed Charges

(mil) Baseline (PPIS transition, new utilization and other

factors) Updated Equipment

Interest

Rate Assumption Discharge Transition CareManagement Input Changes for Certain Radiation Therapy Procedures Total (Cumulative

Impact)

SUPPLIER 57-RADIATION THERAPY CENTERS $ 71 -4% -5% -2% -8% -19%

98-OTHER $ 19 1% 0% -1% 0% 0%

* Table 84 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 2. CY 2012 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 II.A.2. of this proposed rule, we are currently implementing the final year of the 4-year trans ition to new PE RVUs using the PPIS data that were adopted in the CY 2010 PFS final rule with comment period. The impacts of the final year of the transition are generally consistent with the impacts that would be expected based on the impacts displayed in the CY 2012 final rule with comment period. The second factor is the postdischarge transitional care mana gement proposal, under which we would pay separately for care coordination in the 30 days following an inpati ent hospital, outpatie nt hospital observation services or partial hospitalization, SNF, or CMHC discharge from the tr eating physician in the hospital to the beneficiary’s primary physician in the community. Table 83 also reflects updates to the proposed interest rate assumption used in the medical equipment calculation in the PE R VU methodology, the proposed multiple procedure payment reduction policy for the technical co mponent of diagnostic cardiovascular and ophthalmological procedures, and proposed changes to the inputs for certain radiation therapy procedures. Table 84 shows the same information as provide d in Table 83, but ra ther than isolatingCMS-1590-P 686

the policy impact on physician work, PE, and malpr actice separately, Tabl e 84 shows the impact of varied proposed pol icies on total RVUs. b. Combined Impact

Column E of Table 83 and column G of Table 84 display the estimated CY 2013 combined impact on total allowed charges by specialty of all the proposed RVU and MPPR changes. These impacts range from an increase of 7 percent for family practice to a decrease of 19 percent for radiation thera py centers. Again, these impacts are estimated prior to the application of the negative CY 2013 Conversion Factor (CF) update applicable under the current

statute. Table 85 (Impact of Proposed Rule on CY 2013 Payment for Selected Procedures (Based on the March 2012 Preliminary Physician Update)) 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 the most commonly furnished by a broad spectrum of physicia n specialties. There are separate columns that show the change in the facility rates and the nonfacility rates. For an explanation of facility and nonfacility PE, we refer readers to Addendum A of this proposed rule.CMS-1590-P 687TABLE 85: Impact of Proposed Ruleon CY 2013 Payment for Selected Procedures (Based on the March 2012 PreliminaryPhysician Update)*Facility NonfacilityCPT/HCPCS1MOD Short DescriptorCY 20122CY 20133(preupdate)%Change(preupdate)CY 20134(postupdate)%Change(postupdate)CY20122CY20133(preupdate)%Change(preupdate)CY20134(postupdate)%Change(postupdate)11721 Debride nail 6 or more $25.19 $24.37 -3% $17.79 -29% $43.57 $44.00 1% $32.12 -26%17000 Destruct premalg lesion $56.16 $56.19 0% $41.01 -27% $81.01 $81.23 0% $59.29 -27%27130 Total hip arthroplasty $1,445.58 $1,433.42 -1% $1,046.26 -28% NA NA NA NA NA27244 Treat thigh fracture $1,231.48 $1,223.23 -1% $892.84 -27% NA NA NA NA NA27447 Total knee arthroplasty $1,544.29 $1,530.22 -1% $1,116.91 -28% NA NA NA NA NA33533 Cabg arterial single $1,950.35 $1,897.80 -3% $1,385.21 -29% NA NA NA NA NA35301 Rechanneling of artery $1,112.35 $1,085.81 -2% $792.54 -29% NA NA NA NA NA43239 Upper gi endoscopybiopsy$174.61 $172.62 -1% $126.00 -28% $351.61 $348.96 -1% $254.71 -28%66821 After cataract lasersurgery$307.70 $315.79 3% $230.50 -25% $326.08 $334.07 2% $243.84 -25%66984 Cataract surg w/iol 1stage$760.74 $775.43 2% $565.99 -26% NA NA NA NA NA67210 Treatment of retinallesion$504.10 $507.37 1% $370.33 -27% $523.84 $524.63 0% $382.93 -27%71010 Chest x-ray NA NA NA NA NA $23.83 $23.02 -3% $16.80 -29%71010 26 Chest x-ray $8.85 $8.80 -1% $6.42 -27% $8.85 $8.80 -1% $6.42 -27%77056 Mammogram bothbreastsNA NA NA NA NA $112.32 $110.68 -1% $80.79 -28%77056 26 Mammogram bothbreasts$42.55 $41.63 -2% $30.39 -29% $42.55 $41.63 -2% $30.39 -29%77057 Mammogram screening NA NA NA NA NA $81.35 $78.86 -3% $57.56 -29%CMS-1590-P 688Facility NonfacilityCPT/HCPCS1MOD Short DescriptorCY 20122CY 20133(preupdate)%Change(preupdate)CY 20134(postupdate)%Change(postupdate)CY20122CY20133(preupdate)%Change(preupdate)CY20134(postupdate)%Change(postupdate)77057 26 Mammogram screening $34.38 $33.51 -3% $24.46 -29% $34.38 $33.51 -3% $24.46 -29%77427 Radiation txmanagement x5$177.00 $182.77 3% $133.41 -25% $177.00 $182.77 3% $133.41 -25%88305 26 Tissue exam bypathologist$36.08 $35.20 -2% $25.69 -29% $36.08 $35.20 -2% $25.69 -29%90801 Psy dx interview $119.81 $116.10 -3% $84.74 -29% $152.49 $150.62 -1% $109.94 -28%90862 Medicationmanagement$44.25 $43.66 -1% $31.87 -28% $58.54 $58.89 1% $42.99 -27%90935 Hemodialysis oneevaluation$72.84 $70.74 -3% $51.63 -29% NA NA NA NA NA92012 Eye exam establishedpat$51.40 $52.46 2% $38.29 -25% $82.71 $84.62 2% $61.76 -25%92014 Eye exam & treatment $78.29 $79.20 1% $57.81 -26% $119.81 $122.53 2% $89.43 -25%92980 Insert intracoronarystent$837.67 $804.20 -4% $586.99 -30% NA NA NA NA NA93000 ElectrocardiogramcompleteNA NA NA NA NA $19.06 $17.94 -6% $13.09 -31%93010 Electrocardiogramreport$8.51 $8.12 -5% $5.93 -30% $8.51 $8.12 -5% $5.93 -30%93015 Cardiovascular stresstestNA NA NA NA NA $88.50 $83.94 -5% $61.27 -31%93307 26 Tte w/o dopplercomplete$45.95 $44.34 -4% $32.36 -30% $45.95 $44.34 -4% $32.36 -30%93458 26 L hrt artery/ventricleangio$315.87 $315.12 0% $230.00 -27% $315.87 $315.12 0% $230.00 -27%98941 Chiropracticmanipulation$30.63 $30.46 -1% $22.23 -27% $36.08 $36.22 0% $26.43 -27%99203 Office/outpatient visit $74.88 $74.46 -1% $54.35 -27% $105.18 $106.28 1% $77.57 -26%CMS-1590-P 689Facility NonfacilityCPT/HCPCS1MOD Short DescriptorCY 20122CY 20133(preupdate)%Change(preupdate)CY 20134(postupdate)%Change(postupdate)CY20122CY20133(preupdate)%Change(preupdate)CY20134(postupdate)%Change(postupdate)new99213 Office/outpatient visitest$49.69 $49.76 0% $36.32 -27% $70.46 $71.76 2% $52.37 -26%99214 Office/outpatient visitest$76.24 $76.49 0% $55.83 -27% $104.16 $105.26 1% $76.83 -26%99222 Initial hospital care $133.09 $133.70 0% $97.58 -27% NA NA NA NA NA99223 Initial hospital care $195.38 $196.99 1% $143.78 -26% NA NA NA NA NA99231 Subsequent hospitalcare$38.12 $37.91 -1% $27.67 -27% NA NA NA NA NA99232 Subsequent hospitalcare$69.78 $70.06 0% $51.14 -27% NA NA NA NA NA99233 Subsequent hospitalcare$100.07 $100.53 0% $73.37 -27% NA NA NA NA NA99236 Observ/hosp same date $212.05 $211.88 0% $154.65 -27% NA NA NA NA NA99239 Hospital discharge day $103.13 $103.91 1% $75.84 -26% NA NA NA NA NA99283 Emergency dept visit $60.25 $59.57 -1% $43.48 -28% NA NA NA NA NA99284 Emergency dept visit $114.71 $113.73 -1% $83.01 -28% NA NA NA NA NA99291 Critical care first hour $217.16 $216.62 0% $158.11 -27% $267.20 $268.75 1% $196.16 -27%99292 Critical care addl 30min$108.92 $108.65 0% $79.30 -27% $119.47 $119.82 0% $87.46 -27%99348 Home visit est patient NA NA NA NA NA $82.03 $81.57 -1% $59.54 -27%99350 Home visit est patient NA NA NA NA NA $171.21 $172.96 1% $126.24 -26%G0008 Immunization admin NA NA NA NA NA $24.17 $25.05 4% $18.28 -24%*The CY 2013 payment rates are likely to differ from those shown in 85, as the CY 2013 CF is not yet final.CMS-1590-P 6901 CPT codes and descriptions are copyright 2012American Medical Association. All Rights Reserved. Applicable FARS/DFARS apply.2 Payments based on the 2012conversion factor of 34.03763 Payments based on the 2012 conversion factor of 34.0376, adjusted to 33.8572 to include the BN adjustment.4 Payments based on the 2013conversion factor of 24.7124, which includes the BN adjustment.CMS-1590-P 691

D. Effect of Proposed Changes to Medi care Telehealth Se rvices Under the PFS

As discussed in section II.E.3 of this proposed rule, we ar e proposing to add several new

codes to the list of Medicare telehealth servic es. While we expect these changes to increase access to care in rural areas, based on recent ut ilization of similar se rvices already on the telehealth list, we estimate no significant impact on PFS expenditures from the proposed

additions. E. Effect of Proposed Definition of Certified Registered Nurse Anesthetists’ (CRNA) Services As discussed in section II.K.1. of this propos ed rule, we propose to define “anesthesia and related care” as used in the statutory be nefit category for CRNAs under section 1861(bb)(2)

of the Act to include those services that are re lated to anesthesia and included within the state scope of practice for CRNAs in the state in wh ich the services are furnished. CMS has been requested to clarify the definition with regard to chronic pain management services. Contractors

have reached different conclusions as to whether the statutory de finition of “anesthesia services and related care” encompasses the chronic pain management services delivered by CRNAs. Given variations in state scopes of practice, we expect that differences on whether CRNAs can bill Medicare directly for these services will cont inue to exist. In addition, current Medicare policies do not prohibit CRNAs from furnishing th ese services in states where the scope of practice allows them to do so, but only prohibit them from billing Me dicare directly. As a result of these two factors, we do not expect a significant change in how many services are billed to Medicare and therefore, we estimate no significa nt 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 pr oposed rule, we are proposing to revise our current regulation that limits orderi ng of portable x-ray services to only a doctor of medicine or aCMS-1590-P 692

doctor of osteopathy to allow other physicians and nonphysician practitioners (acting within the scope of State law and their Medi care benefit) to order portable x-ray services. We estimate no significant impact on PFS expenditures from the proposed additions. G. Geographic Practice Cost Indices (GPCIs) As discussed in section II.E. of this proposed rule, we are required to review and revise the GPCIs at least every 3 years and phase in th e adjustment over 2 years (if there has not been an adjustment in the past year). For CY 2013, we are not proposing any re visions related to the data or methodologies used to calculate the GPCI s. 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 proposed CY 2013 physician work GPCIs and summarized geographic adjustment factors (GAFs) publis hed 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, th e 1.5 work GPCI floor for Alas ka and the 1.0 PE GPCI floor for frontier States are ap plicable in CY 2013. H. Other Provisions of the Proposed Regulation

1. Ambulance Fee ScheduleAs discussed in section III.A. of this pr oposed rule, section 306 of the TPTCCA and

section 3007 of the MCTRJCA re quire the extension 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 further di scussed in section III.A. of this proposed rule, this legislation is self-i mplementing, and we are proposing to amend the regulation text at §414.610 only to conform the regulations to these se lf-implementing statutory requirements. As a result, we are not making any po licy proposals associated with th ese legislative provisions and there is no associated regulatory impact.CMS-1590-P 693

2. Part B Drug Payment: ASP Issues As discussed in section III of this proposedrule, we are proposing to update the AMPbased price substitution policy that would allow Me dicare to pay based o ff lower market prices for those drugs and biologicals that consistently exceed the applicable threshold percentage. Our impact analysis is unchanged from last y ear (76 FR 73462): based on estimates published in various OIG reports cited in the CY 2012 PFS fi nal rule with comment period (76 FR 73290-1), we believe that this proposal will generate minor savings fo r 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 disc ussed in section III of this proposed rule states that only physicians and not pharmacies (or DM E suppliers) are allowed to bill Medicare under Part B for drugs administered in physicians’ offi ces. We do not believe th at this clarification will significantly impact the quant ity or payment amount for part B drugs that are administered through implanted DME and or the procedures used to refill such pumps. 3. Medicare Program; Durable Medical Equi pment (DME) Face-to-Face Encounters and Written Orders Prior to Delivery a. Overall Impact We estimate the overall economic impact of th is provision on the health care sector to be a cost of $49.95 million in the first year and $285.2 million over 5 years. This overall impact is comprised of additional administrative paperwork costs to private sector providers; a slight increase in Medicare spending, consisting of ad ditional costs and some offsetting savings; and additional opportunity and out-of-po cket costs to Medicare benefici aries. We believe there are likely to be other benefits and cost savings result from the DME face-to-face requirement,CMS-1590-P 694

however, many of those benefits can not be quantified. For instance, we expect to see savings in the form of reduced fraud, waste, and abuse, in cluding a reduction in improper Medicare fee-forservice payments (note that not all improper paym ents are fraudulent). Our detailed cost and benefit analysis is explained below. We are specifically soliciting comment on the potential

increased costs and benefits a ssociated with this provision. TABLE 86: Overall Economic Impact to Health Sector (in millions) Year 1 5 Years Private Sector (Paperwork Cost) $11.2 $94.2 Net Medicare impact of additional visits and G code billings $5 $30

Beneficiaries $29. 75 $161 Total Economic Impact to Health Sector $ 49.95 $ 285.2 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 total 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 reduce inappropriate claims from those DME suppliers who have been abusing or defrauding the program. The impact on these suppliers could be significant, however si nce the purpose of the statute and this regulation is to reduce abusiv e and fraudulent DME sale s, we do not view the burden placed on those providers in the form of lost revenues as a condition that we mustCMS-1590-P 695

mitigate. We believe that the effect on legitim ate suppliers and practitioners would be minimal. Anticipated Effects

b. Costs (1) Private Sector Paperwork Costs We believe that most practitioners are alr eady seeing the beneficiary no more than 90 days prior to the written orde r or within 30 days after the order is written in certain circumstances. However this regulation poten tially requires increas ed 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 economica lly significant threshold. We do not believe that this proposed rule would significantly affect th e number of legitimate written or ders for DME. However, we would expect a decline in fraudul ent, wasteful and abusive orders , thereby causing a decrease in the amount paid for DME overall.

The covered items of DME as outlined in th e M Pages, including the proposed list of Specified Covered Items, contains items that meet at least one of the criteria. The four criteria are as follows: (1) items that currently require a written order prior to deli very per instructions in our Program Integrity Manual; (2) items that cost more than $1,000; (3) items that we, based on our experience and recommendations from the DM E MACs, believe are particularly susceptible to fraud, waste, and abuse; (4) items determined by CMS as vulnerable to fraud, waste and abuse based on reports of the HHS Office of Inspector General, the Government Accountability Office or other oversight entities. We are requesting comments on our criteria.

We also have estimated the number of diffe rent covered Medicare itemssubject to this proposed rule at approximately 164 HCPCS codes fo r items of DME. As new products enter theCMS-1590-P 696

market this number could increa se, which could increase the im pact. In addition, we propose a G-code to pay physicians' for documenting the en counter conducted by a PA, a NP, or a CNS. We anticipate there would be an impact as a result of additional office visits for the faceto-face encounter and the additional 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 include the estimates from section III, of this proposed rule (Collection of Information Requirements section). These are estimated at $11.2 million in year 1 and $ 94.2 million over 5 years. These are driven by the physician documenting face-toface encounters with a beneficiary when it is fu rnished by a PA, a NP, or a CNS, including the time to communicate the practitioners findings to physicians so they can complete the necessary

documentation. TABLE 87: Private Sector Paperwork Costs Year 1 (in millions) 5 Years (in millions) Physician time to document occurrence of a face-to-face encounter cost $9.8 $82.6 PA, NP, or CNS costs $1.4 $11.6 Total Cost $11.2 $94.2 (2) Medicare Costs

Medicare would incur additional costs associ ated with this proposed rule related to

additional face-to-face encounters in the form of office visits, and additional payment for time spent documenting the face-to-face encounter if fu rnished by the PA, NP or CNS and not by the physician directly. Subsequentl y, a G-Code is being created to allow Medicare payment to physicians for documenting the face-to-face enco unters that are furnis hed by a PA, NP, and CNS, and is included in this proposed rule. From a programmatic standpoint we believe that there would be 750,000 additional office visits billed and 500,000 G code claims for the doc umentation. It is difficult to determine howCMS-1590-P 697

many PAs, NPs or CNSs wrote orders for cove red 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 orCNS. For the purpose of this estimate we assume that each order requires a separate f ace-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 indicate approximately 5 percent of those obtai ning covered items of DME in a given year did not see a practitioner in the 90 days preceding the order or in the 30 days after the order was written. We estimate that 500,000 beneficiaries woul d not see their practiti oners in the 90 days prior to the written order for the covered item or in the 30 days after th e order is written. We assume that 1.5 visits per year per affected beneficiary would be re quired to cover the DME services that currently fail to m eet 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 benefici aries who failed to meet the physician contact requirements averaged 3 line items per benefici ary. However, about 40 percent of these line items occur on the same date and so probably refe r to the same event and could be authorized during a single visit. Some additional coordi nation is probable for DME purchases within a narrow time frame. To estimate the impact of the additional office visits we assumed 750,000 additional office visits (1.5 visits * 500,000 benefi ciaries). We also assumed that the average cost for these office visits is around $65, which is consistent with a mid-level office visit under the PFS. This represents the total amount that the practitioners would receive, either from Medicare or the beneficiary, who is res ponsible for the 20 percent coinsurance.CMS-1590-P 698

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 was 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, it was assumed that about 500,000

of these documentation services w ould be billed. We cannot predic t with any certainty the cost of this new service, but believe that $15 is a reasonable estimate. This represents the total amount that the physician 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 $45 million in year 1 and $250 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 is 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 pot ential 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 welcome comments as to the appropriateness of E&M Code 99213 as a proxy measure of time required for a face-to-face encounter. Based on actual data, projecting these historical patterns in light of the draft regulation is not straight-forward. Some line items may be bundled (perhaps because they are used together).CMS-1590-P 699

Beneficiaries may also change their behavior in response to the regulation. For example, beneficiaries would be required to visit a physician in order for Medicare to pay for a new piece of equipment may substitute this visit for a later vi sit that would have been for a routine service. In this situation, the overall number of visits w ould not increase. Moreover, some beneficiaries may choose not to pursue the DME item at that time. On the other hand, the proposed rule points out that some of the encounters reported on the practitioner claim now may not qualify to support the need for the item of DME. We assume that beneficiaries would decide not to schedule 10 percent of the additiona l visits required as a result of not needing the DME item and that some would substitute a required service for a later planned visit.

TABLE 88: Medicare 5-Year Co sts for Additional Face-to-Face Visits and G Code Billings 2013 2014 2015 2016 2017

$45 $45 $50 $50 $60 *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 proposing to make an additional payment through a new G-code for physician work documenting the face-t o-face encounters that are performed by a PA, NP, and CNS. This additional regulatory spen ding is subject to the physician fee schedule budget neutrality requirement under sect ion 1848(c)(2)(B)(ii) (II) of the Act.

(c) Beneficiary Cost Impact From a programmatic standpoint, approximate ly 5 percent of those obtaining covered items of DME in that year did not see a practitio ner in the 90 days preced ing the order or in the 30 days after the order was written. We estimat e that 500,000 beneficiaries would not see their practitioners in the 90 days prior to the written order for the covere d item or in the 30 days afterCMS-1590-P 700

the order is written. As mentioned above, we as sume that 1.5 visits per year per affected beneficiary would be required to cover the DME se rvices 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 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. If it takes a beneficiary 1.25 hours to go to a practitioner, the total estimate is approximately 937,500 hours of time for this proposed rule. We assume that an average trip requires one hour and 15 minutes (45 minutes of round trip travel

time and 30 minutes in the doctor's office—half for wa iting and half for time with the staff). As a proxy we use $20 to estimate the cost per hour incl uding loss of leisure time and travel cost for a beneficiary to see a practitioner. This is consistent with previous estimates of beneficiary leisure time as proposed in the May 4, 2011 proposed rule entitled "Medicare & Medicaid Programs;

Influenza Vaccination Standard for Certain Me dicare & Medicaid Participating Providers and Suppliers" 76 FR 25469. This creates an economic cost of nearly $18.75 million in year 1. Over 5 years this cost could reach $105 million. There w ill be additional out of pocket expenses at the 20 percent Medicare Part B coinsurance. We estim ated this cost to be $10 million in year 1 and $56 million over 5 years. TABLE 89: Beneficiary Cost Impact Result ing from Additional Face-to-Face Visits to Obtain DME Services Year 1 5 Years Total beneficiaries visits impacted 750,000 4.2 million Time per beneficiary 1.25 hours 1.25 hours Total Time 937,500 5.25 million Beneficiary Time Cost ($20) $18. 75 million $105 millionCMS-1590-P 701

Year 1 5 Years Out of Pocket Expense $10 million $56 million Estimated Total Beneficiary Cost Impact $29. 75 million $161 million * 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 anticipate 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 based on the individual’s medical condition, whic h increases the quality of care th at the beneficiary receives. It is difficult to measure how much waste, fraud, and abuse will be prevented as a result of this proposed rule since it is impossibl e to determine what would have happened in the absence of the proposed rule. This provision is expected to improve physician’s documentation of DME, and therefore, will help reduce improper payments and move the agency towards its strategic goal to

reduce the Medicare fee-for-service error rate fo r DME items which has a higher error rate than other Medicare services. The Comprehensive Erro r Rate Testing (CERT) program error rate for DME is high. Fraud is an improper payment, but not all improper payments are fraud. Therefore, creating a measure of how much th is proposed rule would save in terms of a reduction in waste, fraud and abus e is not possible. With that stated, in 2009 Medicare paid $1.7 billion for DME items covered by this proposed ru le, and we estimate that $1.9 billion will be paid for covered items in 2012, and $9.9 billion over 5 years. Preventing waste, fraud and abuse by changing behavior that resu lts in just a small percentage reduction in inappropriate or unnecessary ordering of DME services will generate Medicare savings. This is an area where savings can be found through increased oversight, su ch as this regulation proposes. We believe

that the cost of the visits will be offset by the savings produced by this provision.CMS-1590-P 702

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 90: Year-to-Year Medicare Savings from Reduced DME Services

2013 2014 2015 2016 2017 DME savings -$40 -$40 -$45 -$45 -$50

Based on an analysis of 2007 DME claims, approximately 2 percent of total DME spending was for those beneficiaries who had littl e contact with their physician during the year. 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 fraud and abuse reported elsewhere. The savings occurs because some beneficiaries will not choose to go to th e physician to authorize the DME item, some physicians will not order the items that would otherwise have been provided in the absence of the regulation, and some suppliers will 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 produces an extra 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 benefiting from higher quality care. Beneficiaries would also benefit from reduced out-of-CMS-1590-P 703

pockets costs by not having to pay for unnecessary DME. This accomplishes the objective of achieving greater practitioner accountability noted in the provisions of and the amendments made by section 6407 and other sections of the Affordable Care Act. We welcome public

comment on the benefits of the DME face-to-face requirement, including any data that could help quantify the expected reduction in fra ud, improper payments, or improved beneficiary quality of care.

Alternatives Considered In this proposed rule, we consider a vari ety of options and have sought comments on these options in other sections of this proposed rule. We expect public comment on the way in which the supplier should be notified that a f ace-to-face has occurred wanting to limit the potential burden. We proposed several options for the physician documentation of a face-to-face encounter furnished 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 benefits. In this proposed rule we have also set forth di fferent options of what physician documentation of a face-to-face encounter furnished by a PA, NP or CNS could look like, in the hope of receiving comments on determining the method that will create the least potential burden. There are also options to change the list of covered DME, either by expanding it to cover more items or by minimizing it to cover fewer it ems with low unit costs. We welcome comment

on our selection criteria. 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 belie ve that the consistency with the home health rule benefits providers of serv ices and suppliers, and beneficiar ies but welcome comment on this proposal. 4. Non-Random Prepayment ReviewCMS-1590-P 704

We estimate 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 estimate no significant budgetary impact. 6. Physician Compare Website Section IV.N.2. of this proposed rule discus ses the background of the Physician Compare

Website. As described in section IV.N.2. of this proposed rule, we propose to develop aspects of the Physician Compare Website in stages. In the first stage, which was completed in 2011, we posted the names of those eligib le professionals who satisfact orily participated in the 2009 Physician Quality Reporting System. The second phase of the plan, which was completed in 2012, included posting the names of eligible pr ofessionals who were successful electronic prescribers under the 2009 eRx Ince ntive Program, as well as elig ible professionals (EPs) who participate in the EHR Incentive Program. The next phase of the plan includes posting of performance information with respect to th e 2012 Physician Quality Reporting System GPRO measures which will be completed no sooner than 2013. We are proposing to include performance information for the 2013 Physician Quality Reporting System GPRO web interface measures data no sooner than 2014, in addition to 2013 patient experience data for group practices par ticipating in the 2013 Physician Quality Reporting System GPRO. As reporting of physician performa nce rates and patient experience data on the Physician Compare Website will be performed direc tly by us using the data that we collect under the 2012 Physician Quality Reporting System GPRO and other data collection methods, we do not anticipate any notable impact on eligible professionals with resp ect to the posting of information on the Physician Compare Website.CMS-1590-P 705

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 incentives was paid by CMS for the 2010 program year, which encompassed 168,843 individual eligible professiona ls. In 2010, eligible professionals earned a 2.0 percent incentive (i.e., a bonus payment equal to 2.0 percent of the total allowed part B charges for covered professional services under the PFS furnished by the eligible professional during the reporting period) for satisfactory re porting under the Physician Quality Reporting System. For 2013 and 2014, eligible professiona ls can earn a 0.5 percent incentive for satisfactory reporting, a reduction of 1.5 percent from 2010. Theref ore, based on 2010,which is the latest year in which PQRS has full particip ation data, we would expe ct that approximately $97 million (approximately 1⁄4 of $391,635,495) in incenti ve payments would be distributed to eligible professionals who satisfactorily repor t. However, we expect that, due to the implementation of payment adjustments beginn ing in 2015, participati on in the Physician Quality Reporting System would rise incrementally to approximately 300,000 eligible professionals and 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 estimate that the average amount per eligible pr ofessional earning an incentive in 2013 and 2014 would be $539. Therefore, we estimate that the Physician Quality Reporting System would distribute appr oximately $162 million ($539 x 300,000 eligible professionals) and $216 million ($539 x 400,000 eligible professionals) in in centive payments in 2013 and 2014, respectively. We believe these incentive payments will help offset the cost to eligible professionals for participating in the Physician Quality Reporting System for theCMS-1590-P 706

applicable year. Please note that, beginning 2015, incentive paym ents for satisfactory reporting in the Physician Quality Reporting System will cease and payment adjustments for not satisfactory reporting will commence.

We note that the total burden associated with participating in the Physician Quality Reporting System is the time and effort associated with indicating intent to participate in the Physician Quality Reporting System, if appli cable, and submitting Physician Quality Reporting System quality measures data. When establishing these burden estimates, we assume the following:

• The requirements for reporting for the Physician Quality Reporting System 2013 and 2014 incentives and payment adjustments for 2015 and beyond would be established as proposed in this 2013 Medicare PFS proposed rule.

• 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.

• 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 Physician Quality Reporting System quality measures. According to the Bureau of Labor Statistics, the mean hourly wage for a billing clerk is approximately $16/hour whereas the mean hourly wage for a computer analyst is approximately $40/hour. For an eligible professional who wishes to participate in the Physician Quality Reporting System as an individual, the elig ible professional need not indicate his/her intent to participate. The eligible professional may si mply begin reporting quality m easures data. Therefore, these burden estimates for individual eligible professi onals participating in the Physician QualityCMS-1590-P 707

Reporting System are based on the reporting mech anism 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 Phys ician Quality Reporting Sy stem measures list, review the various reporting op tions, and select a reporting op tion and measures on which to report and 3 hours to review the measure sp ecifications and develop a mechanism for incorporating reporting of the sele cted measures into their office work flows. Therefore, we

believe that the initial administrative costs associ ated with participating in the Physician Quality Reporting System would be approximately $80 ($16/hour x 5 hours). With respect to an eligible professional who participates in the Physician Quality Reporting System via claims, the eligible prof essional must gather the required information, select the appropriate qualit y data codes (QDCs), and incl ude the appropriate QDCs on the claims they submit for payment. The Physic ian Quality Reporting System 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 continue to estimate that the time need ed to perform all the steps necessary to report each measure via claims will range from 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 estimate that time cost of reporting for an eligible pr ofessional via claims would 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 proposed that an eligible prof essional would need to report 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.CMS-1590-P 708

However, in prior years, when the reporting thre shold was 80 percent, we found that the median number of reporting cases for each measure wa s 9. Since we are proposing to reduce the reporting threshold to 50 percent, we estimate that the average number of reporting cases for

each measure would be reduced to 6. Based on these estimates, we estimate that the total cost of reporting for an eligible prof essional choosing the claims-based reporting mechanism would range from ($0.50/per reported case x 6 re ported cases) $3.00 to ($24.00/reported case x 6 reported cases) $144. We note that, for the 2015 and 2016 PQRS payment adjustments, we are proposing 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 fo r to participate in PQRS as an administrative claims reporter. Therefore, we estimate that the cost of under going the GPRO selection process will be ($16/hour x 2 hours) $32. With respect to reporting, we note that any bu rden associated with reporting would be negligible, as an eligib le professional or group practice w ould not be required to attach reporting G-codes on the claims they submit. Rather, CMS would bear the burden of reporting with respect to selecting which measures to report. We note that there would be no additional burden on the eligible professional or group prac tice to submit these claims, as the eligible professional or group practice would have alr eady submitted these claims for reimbursement

purposes.CMS-1590-P 709

With respect to an eligib le professional or group pract ice who participates in the Physician Quality Reporting System via a qualifie d registry, direct EHR product, or EHR data submission vendor product, we believe there woul d be little to no burden associated for an eligible professional to report Physician Qual ity Reporting System 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 purchasing a qualified registry, direct EHR product, or EH R data submission vendor, we believe that an eligible professional or group practice would not purchase a qu alified registry, direct EHR product, or EHR data submission vendor product solely for the purpose of reporting Physician Quality Reporting System quality measures. Th erefore, we have not included the cost of purchasing a qualified registry, direct EHR, or EHR data s ubmission vendor product in our

burden estimates. Unlike eligible professionals who choose to report individually, we note that eligible professionals choosing to participate as part of a group practice under th e GPRO must indicate their intent to participate in the Physician Qu ality Reporting System as a group practice. The total burden for group practices who submit Physician Qua lity Reporting System quality measures data via the proposed GPRO web-interf ace would be the time and effort associated with submitting this data. To submit quality measures data for the Physician Quality Reporting System, a group practice would need to (1) be sel ected to participate in the Physician Quality Reporting System GPRO and (2) report quality measures data. With respect to the administrative duties for being selected to partic ipate in the Physician Quality Reporting System as a GPRO, we believe it woul d take approximately 6 hours – in cluding 2 hours to decode to participate in the Physician Quality Reporting Syst em as a GPRO, 2 hours to self-nominate, and 2 hours to undergo the vetting process with CMS o fficials – for a group practi ce to be selected toCMS-1590-P 710

participate in the Physician Quality Reporting Syst em GPRO for the applicable year. Therefore, we estimate that the cost of undergoing the GP RO selection process wo uld be ($16/hour x 6 hours) $96. With respect to reportin g, the total reporting burden is the time and effort associated with the group practice submitting the quality me asures data (that is, completed the data collection interface). Based on burden estimates for the PGP demonstration, which uses the same data submission methods, we estimate th e burden associated with a group practice completing the data collection interface would be approximately 79 hours. Therefore, we estimate that the report cost for a group pract ice to submit Physician Quality Reporting System quality measures data for the proposed reporti ng options in an applic able year would be ($40/hour x 79 hours) $3,160. Eligible professionals who wish to quality for an additional 0.5% Maintenance of Certification Program incentive must “more freq uently” than is required to qualify for or maintain 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 th e applicable year. A lthough we understand that there is a cost associated with participating in a Maintenance of Certific ation Board, we believe that most of the eligible prof essionals attempting to earn this additional incentiv e would already

be enrolled in a Maintenance of Certification board for reasons other th an earning the additional Maintenance 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 time needed to complete the practice assessment co mponent. We expect that the amount of time needed to complete a qualified Maintenance of Certification Pr ogram practice assessment would be spread out over time since a quality improveme nt component is often required. With respect to the practice assessment component, according to an informal poll conducted by ABMS inCMS-1590-P 711

2012, the time an individual spends to complete the practice assessment component of the

Maintenance of Certifica tion ranges from 8-12 hours. Aside from the burden of eligible professi onals and group practices participating in the Physician Quality Reporting System, we believe that registry, direct EHR, and EHR data submission vendor products incur costs associated with participating in the Physician Quality Reporting System. With respect to qualified registries, the total burden for qualified registries who submit Physician Quality Reporting System Quality Measures Data would be the time and effort associated with submitting this data. To submit quality measures data for the proposed program years for Physician Quality Repor ting System, a registry would n eed to (1) become qualified for the applicable year and (2) report quality measures data on behalf of its eligible professionals. With respect to administrative duties related to th e qualification process, we estimate that it will

take a total of 10 hours – including 1 hour to complete the se lf-nomination statement, 2 hours to interview with CMS, 2 hours to calculate numer ators, denominators, and measure results for each measure the registry wishes to report usi ng a CMS-provided measure flow, and 5 hours to complete an XML submission – to become qua lified to report Physician Quality Reporting System quality measures data. Therefore, we estimate that it would cost a registry approximately ($16.00/hour x 10 hours) $160 to become qualified to submit Physician Quality Reporting System 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 is the time and effort associated with the registry calculating 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 irrespectiveCMS-1590-P 712

of participating in the Physicia n Quality Reporting System. Ther efore, we believe there would

be little to no additional burden associated w ith reporting Physician Quality Reporting System quality measures data. Whether there is a ny additional reporting burden will vary with each registry, depending on the registry’s level of savv y with submitting quality measures data for the Physician Quality Reporting System. With respect to EHR products, the total bu rden for direct EHR products and EHR data submission vendors who submit Physician Quality Reporting System Quality Measures Data

would be the time and effort associated with su bmitting this data. To submit quality measures data for the proposed program years under the Physician Quality Reporting System, a direct EHR product or EHR data submission vendor woul d need to report quality measures data on behalf of its eligible professiona ls. Please note that we are not proposing to continue to require direct EHR products and EHR data submission ve ndors to become qualified to submit Physician Quality Reporting System 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 Physician Qualit y Reporting System and the vendor’s system and programming capabilitie s. We believe it would take a vendor approximately 40 hours (for experienced vendors) to 200 hours (for first-time vendor participants) to submit Physician Quality Reporting System quality measures data. Therefore, we estimate that it would cost an EHR vendor ($40/hour x 40 hours) $1,600 to $8,000 to submit Physician Quality Reporting System quality measures data for its eligible professionals.

TABLE 91: Estimated Costs for Reporting Ph ysician Quality Reporting System Quality Measures Data for Eligible Professionals

Estimated Hours Estimated Cases Number of Measures Hourly Rate Total Cost Individual Eligible Professional 5.0 1 N/A $16 $80CMS-1590-P 713

Estimated Hours Estimated Cases Number of Measures Hourly Rate Total Cost (EP): Preparation 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 92: Estimated Costs to Vendors to Part icipate 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 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 proposed provisions contained in this CY 2013 MPFS proposed rule would make additional changes to the require ments for the 2013 incentive and 2014 payment adjustment for group practices. Specifically, CM S is proposing to add a new criterion for being a successful electronic prescrib er for the 2013 incentive and 2014 payment adjustments for group practices of 2-24 eligible profe ssionals given that CMS is propos ing to modify the definition of group practice. However, we note that any additi onal impact a result of this proposal would be minimal, as it is our understanding the eligible professionals who woul d use this new reporting option are already participating in the eRx Incentiv e Program as individual eligible professionals. For the reasons stated, the proposals would 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. 9. Medicare Shared Savings ProgramCMS-1590-P 714

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 proposals for the Medicare Shared Savings Program set forth in the CY 2013 MPFS proposed rule impose requirements that eligible professionals in group practices within accountable care organiza tions would need to satisfy for purposes of the PQRS payment adjustment under the Medicare Shared Savings Pr ogram as the proposals related to the ACOs for the PQRS payment adjustment mirror the require ments that were established for earning the PQRS incentives. 10. Medicare EHR Incentive Program Please note that the requirements for repor ting clinical quality measures (CQMs) to achieve meaningful use under Stage 1 for the EHR Incentive Program were established in a standalone final rule published on July 28, 2010 (75 FR 44544). The proposal s contained in this CY 2013 MPFS proposed rule merely propose methods to report CQMs to meet the CQM objective for achieving meaningful use under Stage 1 for the EHR Incentive Program. Therefore, the impacts to the proposal we are making to extend the use of attestation and the Physician Quality Reporting System-Medicare EHR Incentive Pilot to report CQMs were absorbed in the impacts discussion published in the EHR Incentive Program final rule published on July 28, 2010. 11. Chiropractic Services Demonstration

As discussed in section III of this rule with comment period, we are continuing 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,CMS-1590-P 715

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 th e payment amount under the PFS for the chiropractic CPT codes (that is, CPT codes 98940, 98941, and 98942) by approximately 2 percent. 11. Physician Value-Based Payment Modifier an d the Physician Feedback Reporting Program The proposed changes to the Physician Fee dback Program in section IV.I. of this proposed rule would not impact CY 201 3 physician payments under the PFS. However, we expect that our proposals to use the Physic ian Quality Reporting System (PQRS) quality measures in the Physician Feedback reports and in the value modifier to be implemented in CY 2015 may result in increased part icipation in the PQRS in CY 201 3 . We anticipate that as we approach implementation of the value modifier , physicians will increasi ngly participate in the PQRS to determine and understand how the valu e modifier could affect their payments. 12. 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 proposed rule, section 1861(s)(10)(B) of the Act authorizes Medicare coverage of hepatitis B vaccine and its admi nistration if furnished to an individual who is at high or in termediate risk of contracting he patitis B, as determined by the Secretary under regulations. Our current regu lations are established at 42 CFR §410.63. We are proposing to modify §410.63(a)(1) by adding persons diagnosed with diabetes mellitus to the high risk group. While it is estimated that approximately 23 percent of non-institutionalized Medicare beneficiaries are diagnosed with diab etes mellitus, it is unclear how many of these beneficiaries will obtain these services. Therefore, the estimated impact of adding personsCMS-1590-P 716

diagnosed with diabetes mellitus to the high risk group eligible for coverage of hepatitis B

vaccine and its administration is unknown for CY 2013. 13. 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 prop osed in this section of the proposed rule imposes no new requirements as the burden in usi ng the updated standards is anticipated to be the same as using the old standards. We believe that prescribers and dispensers that are now eprescribing largely invested in the hardware, software, and connec tivity necessary to e-prescribe. We do not anticipate that the retirement of NCPDP SCRIPT 8.1 in fa vor of NCPDP SCRIPT 10.6 will result in significant costs. We also believ e the same holds true for the standard updates for NCPDP Formulary and Benefits 3.0. The back ward compatible Formulary and Benefits 3.0 imposes no new requirements on entities that are already e-prescribing. Entities that choose to use Formulary and Benefits 3.0 would be doing so voluntarily. The proposed removal of the LTC exception to the NCPDP SCRIPT standard would impose a small burden on the LTC industry. LTC entities who use and developed proprietary solutions may need to invest in software programming updates if they had not already incorporated the Part D e-prescribing standards in their solutions. It is re asonable to assume that a small number of proprietary solutions would have to modify their software in order to adhere to the adopted e-prescribing standard s. Other cost may be incurre d though staff training on the use of the e-prescribing standards and the use of an e-prescribi ng solution if adopted by a LTC facility. Additional training cost may involve prescribers and dispensers learning the new workflows that an electronic prescr iption may or may not require.

I. Alternatives ConsideredCMS-1590-P 717

This proposed rule contains a range of po licies, including some provisions related to specific statutory provisions. The preceding prea mble provides descriptions of the statutory provisions that are addressed, id entifies those policies when discretion has been exercised, presents rationale for our final policies and, where relevant, alternatives that were considered. J. Impact on Beneficiaries There are a number of changes in this pr oposed rule that would have an effect on beneficiaries. In general, we believe that many of the proposed changes, including the refinements of the PQRS with its focus on m easuring, submitting, and analyzing quality data; establishing the basis for the value-based paym ent modifier to adjust physician payment beginning in CY 2015; creating a separate pa yment for post-discharge transitional care management services in the 30 days after a bene ficiary has been discharged from an inpatient hospital admission, from outpatient observation services and pa rtial hospitalization program,, from a SNF, or from a CMHC; improved accuracy in payment through revisions to the inputs used to calculate payments under the PFS for certain radiation ther apy services; capital interest rate assumptions; multiple procedure payment reduction for ophthalmology and cardiovascular diagnostic tests; and revisions to payment fo r Part B drugs will have a positive impact and improve the quality and value of care furn ished to Medicare beneficiaries. Most of the aforementioned proposed polic y changes could result in a change in beneficiary liability as it relates to coinsurance (which is 20 percent of the fee schedule amount if applicable for the particular provision after the beneficiary has met the deductible). To illustrate this point, as shown in Table 85, the CY 2012 na tional payment amount in the nonfacility setting for CPT code 99203 (Office/outpatient visit, ne w) is $105.18 which means that in CY 2012 a beneficiary would be responsible for 20 per cent of this amount, or $21.04. Based on this proposed rule, using the current (CY 2012) CF of 34.0376, the CY 2013 national paymentCMS-1590-P 718

amount in the nonfacility sett ing for CPT code 99203, as shown in Table 85, is $106.31, which means that, in CY 2013, the proposed beneficiary coinsurance for this service would be $21.26 K. Accounting Statement As required by OMB Circul ar A-4 (available at http://www.whitehouse.gov/omb/circulars/a004/a- 4.pdf), in Table 93 (Accounting Statement), we have prepared an accounting statement showi ng the estimated expenditures associated with this proposed rule. This estimate includes the es timated FY 2012 cash benefit impact associated

with certain Affordable Care Act and MCTRJCA provisions, and the CY 2013 incurred benefit impact associated with the estimated CY 2013 P FS conversion factor update based on the MidSession Review of the FY 2013 President's Budget baseline. TABLE 93: Accounting Statement: Cla ssification of Estimated Expenditures

CATEGORY TRANSFERS CY 2013 Annualized Monetized Tran sfers Estimated decrease in expenditures of $23.5 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 94: Accounting Statement: Classification of Estima ted Costs, Transfer, and Savings ($ In Millions)CMS-1590-P 719

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

CY 2013 Annualized monetized costs of beneficiary travel time $9.37 millions

CATEGORY TRANSFER

CY 2013 Annualized Monetized Transfers of beneficiary cost coinsurance $10 millions

From Whom To Whom? Beneficiaries to Federal Government CATEGORY TRANSFERCY 2013 Medicare face-to-face visit and Gcode payments $16.2 millions

From Whom To Whom? Federal Government to DME providers

L. Conclusion The analysis in the previous sections, toge ther with the remainder of this preamble, provides an initial "Regulatory Fl exibility Analysis." The previous analysis, together with the remainder of this preamble, provides a Regulatory Impact Analysis. In accordance with the provisions of Executive Order 12866, this regulation was reviewed by the Office of Management and Budget.CMS-1590-P 720

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). Health professionals, Medicare, Penalties, Privacy, Reporting 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.

42 CFR Part 495CMS-1590-P 721

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.CMS-1590-P 722

For the reasons set forth in the preamble, the Centers for Medicar e & Medicaid Services propose to 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 410.32 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.

* * * * * (b) * * * (2) * * * (iii) Diagnostic psycholog ical and neuropsychological testing services when—

* * * * * (c) * * * (2) These services are ordered by a physic ian as provided in (a ) or by a nonphysician practitioner as provided in (a)(2) of this section. (d) * * * (2) * * *CMS-1590-P 723

(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] 3. Amend §410.37 by-- A. Revising paragraph (a)(1)(ii i) by removing the phrase “In th e case of an individual at high risk for colorectal cancer,”. 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)”. 4. 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. ACMS-1590-P 724

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 Health care 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 ) Wheelchair accessories. (4 ) Oxygen and respiratory equipment. (5 ) Hospital beds and accessories. (6 ) Traction-cervical. (B) Any item of durable medical equipm ent that appears on the Durable Medical 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 aCMS-1590-P 725

face-to-face encounter with the beneficiary on the date of the written order or during either of the following: (1 ) Up to 90 days before the date of the written order. (2 ) Within 30 days after the da te that the order is written. (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 assessment, evaluate, 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 information as it may be appropriate). (i) For purposes of paragra ph (g), a face-to-face encounter does not include DME items

and services furnished from an "incident to" service. (ii) For purposes of paragraph (g), a face -to-face beneficiary en counter may occur via

telehealth in accordance w ith 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) Prescribing practitioner NPI.CMS-1590-P 726

(iv) Signature of the prescribing practitioner. (v) The date of the order. (vi) The beneficiary's diagnosis. (vii) Necessary proper usage instructions, as applicable (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. 5. 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.

* * * * *CMS-1590-P 727

6. Section 410.59 is amended by adding pa ragraph (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.

* * * * * 7. Section 410.60 is amended by adding pa ragraph (a)(4) to read as follows: § 410.60 Outpatient physical therapy services: Conditions. (a) * * * (4) Claims submitted for furnished services contain prescribed information on patient

functional limitations.

* * * * * 8. 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.

* * * * * 9. Section 410.62 is amended by adding pa ragraph (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 patientCMS-1590-P 728

functional limitations.

* * * * * 10. Section 410.63 is amended by adding paragr aph (a)(1)(viii) to read as follows: §410.63 Hepatitis B vaccine and blood clotting factors: Conditions.

* * * (a) * * * (1) * * * (viii) Persons diagnosed with diabetes mellitus.

* * * * * 11. Section 410.69 is amended by adding the defi nition “Anesthesia and related care” to paragraph (b) in alphabetical order to read as follows: §410.69 Services of a certified regis tered nurse anesthetist or an anesthesiologist’s assistant:

Basic rule and definitions.

* * * * * (b) * * *

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 which the services

are furnished.

* * * * * 12. Section 410.78 is amending by revising the intr oductory text of paragraph (b) to read

as follows: §410.78 Telehealth services.

* * * * *CMS-1590-P 729

(b) General rule . Medicare Part B pays for office or other outpatient visits, subsequent hospital care services (with the limitation of one telehealth visit every three 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) and with the limitation of one telehealth visit every 30 days by the patient’s adm itting physician or nonphysician practitioner), professional consultations, psychi atric diagnostic interview exam ination, neurobehavioral status exam, individual psychotherapy, pharmacologic ma nagement, end-stage renal disease-related

services included in the monthl y capitation payment (except for one “hands on” visit per month to examine the access site), individual and group medical nutrition therap y services, individual and group kidney disease education services, in dividual 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 effectiv e injection training), individual and group health and behavior

assessment and intervention servic es, smoking cessation services, al cohol and/or substance abuse and brief intervention services, screening and be havioral 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 by an interactive telecommunications system if the following conditions are met:

* * * * * 13. 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.CMS-1590-P 730

* * * * * (c) * * * (1) * * * (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. 14. Section 410.160 is amended by-- A. Redesignating paragraphs (b)(8) through (b )(13) as paragraphs (b)(9) through (b)(14). B. Adding new paragraph (b)(8).

The addition reads as follows: §410.160 Part B annual deductible.

* * * * * (b) * * * (8) Beginning January 1, 2011, a surgical se rvice furnished in connection with, as a result of, and in the same clinic al encounter as a pla nned colorectal screening test. A surgical

service furnished in connection wi th, as a result of, and in the same clinical encounter as a colorectal screening test means —a surgical se rvice furnished on the same date as a planned

colorectal cancer screen ing test as described in §410.37 of this part.

* * * * *

PART 414--PAYMENT FOR PART B MEDI CAL AND OTHER HEALTH SERVICES 15. The authority citation for part 414 continues to read as follows:CMS-1590-P 731

Authority : Secs. 1102, 1871, and 1881(b)(l) of the So cial Security Act (42 U.S.C. 1302, 1395hh, and 1395rr(b)(l)). 16. Section 414.65 is amended by revising pa ragraph (a)(1) to read as follows: §414.65 Payment for telehealth services. (a) * * * (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.CMS-1590-P 732

(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. (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.

* * * * * 17. Section 414.90 is amended by-- A. In paragraph (b), revising the definiti ons “Group practice” and “Qualified registry.” B. Removing the term “Qualified electronic health record product”. C. Adding the definitions “Administrative claims,” “Direct electronic health record (EHR) product,” “Electronic hea lth record (EHR) data submi ssion vendor product,” and “Group practice reporting option (GPRO) 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 paragraphs (f), (g), and (k).

The revisions and additions read as follows: §414.90 Physician Quality Reporting System.

* * * * * (b) * * *CMS-1590-P 733

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 determines which m easures an eligible 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 electronic health record vendor’s product or version that acts as an intermediary to submit data on Physician Quality Reporting System measures on behalf of an eligible professional or group practice.

* * * * * 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 SystemCMS-1590-P 734

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. If 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 the following 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 sec tion 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 theCMS-1590-P 735

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 group 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-- (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 practiceCMS-1590-P 736

reporting option, the eligible pr ofessional cannot individually qualify for a Physician Quality 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) (i) and (ii) 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)(1) of this section, an eligible professional 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.CMS-1590-P 737

(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)(2)(ii) 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 the Physician Quality Reporting System quality measure set, CMS will use consensus-based qualityCMS-1590-P 738

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 qualif y 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 reporting m echanisms specified in paragr aph (g)(2) of th is 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.CMS-1590-P 739

(A) For 2011, such 6-month repor ting 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 program year 2011 and subsequent program years, an eligible professional who wishes to participate in the Physician Quality Reporting System must report information on the individual Physician Qu ality Reporting System quality measures or Physician Quality Reporting System measures gr oups identified by CMS in one of the following

manners: (i) Claims . Reporting the individual Physician Quality Reporting System quality measures or Physician Quality Reporting System measures groups to CMS, by no later than 2 months after the end of the applicable reporti ng period, on the eligible professional's Medicare Part B claims for covered profe ssional services furnished duri ng the applicable reporting period. (A) If an eligible prof essional re-submits a Medicare Part B claim for reprocessing, the eligib le professional may not attach a G- code at that time for reporting on individual Physician Quality Reporting System measures or measures groups. (B) [Reserved] (ii) Registry . Reporting the individual Physician Quality Reporting System quality measures or Physician Quality Reporting System measures groups 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 submitCMS-1590-P 740

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 the individual Phys ician Quality Reporting System quality measures to CMS by extracting clinical data using a secure da ta submission method, as required by CMS, from a direct EHR product (as defi ned in paragraph (b) of this section) by the deadline specified by CMS for covered profe ssional services furnished by the eligible professional during the app licable reporting period. (iv) EHR data submission vendor

. Reporting the individual P hysician 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 paragraph (b) of this section) by the deadline specified by CMS for covered professional services furnished by the eligible professional during the applicable reporting period. (v) Web-interface . For a group practices defined in paragraph (b) of this section, reporting individual Physician Quality Reporting System quality measures to CMS using a CMS

web-interface in the form and manner and by the deadline specified by CMS. (3) 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. (h) Requirements for the payment adjustments . In order to satisfy the requirements for 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 ofCMS-1590-P 741

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 specifi ed in paragraph (h)(2) of this section. (1) For purposes of this paragraph, the repor ting 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 two 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 fall two years prior to the year in which the payment adjustment is applied, is also available. (ii) [Reserved] (2) An eligible professional (or in the case of a group practice under paragraph (i) of this section, by the group practice) who wishes to pa rticipate in the Physician Quality Reporting System must report information on the individua l Physician Quality Reporting System measures or Physician Quality Reporting System measur es groups identified by CMS using one of the following reporting mechanisms: (i) Claims . Reporting the individual Physicia n Quality Reporting System quality measures or Physician Quality Reporting System measures groups to CMS, by no later than 2 months after the end of the applicable reporti ng period, on the eligible professional's Medicare Part B claims for covered profe ssional services furnished duri ng the applicable reporting period. (A) Medicare Part B claims may not be repr ocessed or reopened for the sole purpose or reporting on individual Physic ian Quality Reporting System m easures or measures groups. (B) [Reserved]CMS-1590-P 742

(ii) Qualified registry . Reporting the individual Phys ician Quality Reporting System quality measures or Physician Qu ality Reporting System measures groups to a qualified registry (as specified in paragraph (b) of this secti on) in the form and manner and by the deadline specified by the qualified registry selected by the eligible professional. The sele cted registry will submit information, as required by CMS, for c overed professional serv ices furnished by the eligible professional during the applicable reporting period to CM S on the eligible professional's

behalf. (iii) Direct EHR product . Reporting the individual Physic ian Quality Reporting System quality measures to CMS by extracting clinical data using a secure da ta submission method, as required by CMS, from a direct EHR product (as defi ned in paragraph (b) of this section) by the deadline specified by CMS for covered profe ssional services furnished by the eligible professional during the a pplicable reporting period. (iv) EHR data submission vendor . Reporting the individual 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 paragraph (b) of this section) by the deadline specified by CMS for covered professional services furnished by the eligible professional during the a pplicable reporting period. (v) GPRO web-interface . For a group practices defined in paragraph (b) of this section that are comprised of 25 or more eligible prof essionals, reporting individual 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. (vi) Administrative claims . For the 2015 and 2016 payment adjustments, reporting certain administrative claims individual Physician Quality Reporting System quality measures during the applicable reporting pe riod. Eligible professionals and (or in the case of a groupCMS-1590-P 743

practice under paragraph (i) of this section) that are administrative claims reporters must meet the following requirement for the payment adjustment: (A) Register to participate in the Phys ician Quality Reporting System using the administrative claims reporting option. (B) Reporting Medicare Part B claims data for CMS to determine whether the eligible professional or group practice has performed servi ces applicable to certa in individual Physician Quality Reporting System quality measures. (3) Although an eligible prof essional or group practice may a ttempt to meet the criteria for satisfactory reporting for the Physician Qu ality Reporting System payment adjustment by reporting on individual Physic ian Quality Reporting System quality measures or measures groups using more than one re porting mechanism (as specified in paragraph (h)(2) of this section), the eligible professi onal or group practice must satisfy the criteria for satisfactory reporting for the Physician Quality Reporting Sy stem payment adjustment under one reporting mechanism per TIN/NPI combination for a program year. (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) Be selected by CMS to participate in the Physician Quality Reporting System group practice reporting option. (3) Report measures in the form and manner specified by CMS. (4) Meet other requirements for sa tisfactory reporting specified by CMS. (5) Meet participation requirements.CMS-1590-P 744

(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. 18. 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) an d reserving paragraph (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) * * * (A) * * * (5 ) Eligible professionals who achieve mean ingful use during the respective 6 or 12- month payment adjustment reporting period.CMS-1590-P 745

(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]

Informal review

. Eligible professionals (or in the case of reporting under paragraph (e) of this section, group practices) may s eek an informal review of the determination that an eligible professional (or in the case of reporting under para graph (e) of this section, group practices) did not meet the requirements for the 2013 incenti ve or the 2013 and 2014 payment adjustments. (1) To request an informal review for th e 2013 incentive, an elig ible professional or group practice must submit a request to CMS with in 90 days of the release of the feedback reports. The request must be submitted in writi ng and summarize the concern(s) and reasons for requesting an informal review and may also in clude 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 by January 31 of the year in which the eligible professional is receiving th e applicable payment adjustment. The request must be submitted in writing and summarize the concern(s) and reasons for requesting an informal review and may also include information to assist in the review.CMS-1590-P 746

(3) CMS will provide a written response of CMS’ determination within 90 days of the receipt of the request. (i) All decisions based on the informal review are final. (ii) There is no furthe r review or appeal.

* * * * * 19. 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.

* * * * * (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 comparedCMS-1590-P 747

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. 20. Section 414.904 is amended by revising paragraphs (d)(3)(i i), (d)(3)(iii) and (d)(3)(iv).

B. The revisions 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: (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 a critical or medically necessary drug identified by the FDA to be in short supply at the time that

ASP calculations are finalized.CMS-1590-P 748

(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.

* * * * * 21. 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.

414.1220 Reporting mechanisms for the value -based payment modifier under the physician fee schedule. 414.1225 Alignment of Physician Quality Report ing System 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.CMS-1590-P 749

414.1245 Scoring methods for the va lue-based payment modifier. 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 Payment adjustments. 414.1275 Payment modifier scoring methodology.

414.1280 Limitation of review. 414.1285 Inquiry process. Subpart N--Value-Based Payment Modifi er under the Physician Fee Schedule § 414.1200 Basis and scope. (a) Basis

. This part/section implements section 1848(p) of the Act by establishing a payment modifier that provides for differe ntial payment starting in 2015 to a group of physicians under the Medicare physician fee sche dule based on the quality of care furnished compared to cost during a performance period. (b) Scope

. This subpart sets forth the following: (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 composite of the value-based payment modifier. (5) Additional measures for groups of physicians. (6) Cost measures. (7) Attribution for quality of care and cost measures.CMS-1590-P 750

(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) Payment modifier scoring methodology. (15) Limitation of review. (16) Inquiry process. § 414.1205 Definitions. As used in this section, 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.

Electronic health record (EHR) has the same meaning given this term under §414.92 of this chapter. Eligible professional has the same meaning given th is term under section1848(k)(5)(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), whoCMS-1590-P 751

have reassigned their Medicare bi lling rights to the TI N, as determined at the time the group of physicians is selected to participate under th e Physician Quality Reporting System GPRO.

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 sc ore derived from the CMS Hierarchical Condition Categories (HCC) model. Taxpayer Identification Number (TIN) has the same meaning given this term under §425.20 of this chapter. Value-based payment modifier means the percentage by which amounts paid to a physician or group of physicians under th e physician fee schedule are adjusted. Value-based payment modifier satisfactory reporting criteria means the criteria for satisfactory reporting of data on Physician Qua lity Reporting System quality measures for the

2013 and 2014 incentive or the criteria for satisf actory reporting using the Physician Quality Reporting System administrative claims-based re porting mechanism, which is applicable to the 2015 and 2016 PQRS payment adjustment. § 414.1210 Application of the value-based payment modifier. (a) The value-based payment modifier is appl icable to the items and services furnishedCMS-1590-P 752

under the Medicare Part B physic ian fee schedule by physicians in groups of physicians with 25 or more eligible professiona ls starting on January 1, 2015. (b) Exceptions : (1) Groups of physicians with 25 or more eligib le professionals that are participating in the Medicare Shared Savings Program or the Pioneer ACO program. (2) [Reserved] § 414.1215 Performance and payment adjustment periods for the value-based payment

modifier. (a) The performance period is calendar year 2013 for payment adjustments to be made in the calendar year 2015 payment adjustment period. (b) The performance period is calendar year 2014 for payment adjustments to be made in the calendar year 2016 payment adjustment period. § 414.1220 Reporting mechanisms for the value-based payment modifier under the physician fee schedule. Groups of physicians may submit data on quality of care measures as specified under the Physician Quality Reporting System and in § 414.90(g). § 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 2013 are used to calculate the value-based 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:CMS-1590-P 753

(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 rates of potentially prev entable hospital admissions for dehydration, urinary tract infections, and bacterial pneumonia. (c) Rates of an all-cause hos pital readmissions measure. (d) A 30-day post-discharge visit measure. § 414.1235 Cost measures. Costs for groups of physicians are assessed based on the following five 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 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.CMS-1590-P 754

Beneficiaries are attributed to groups of physicians using the method specified under the Physician Quality Reporting System. § 414.1245 Scoring methods for the value-based payment modifier. For each quality of care and cost measure, a standardized score is calculated for each group of physicians by dividing-- (1) The difference between their performance rate and the benchmark, by (2) The measure’s standard deviation. § 414.1250 Benchmarks for quality of care measures. The benchmark for each quality of care measur e is the national mean for that measure’s performance rate during the perf ormance period. In calculating the national benchmark, groups of physicians’ performance rates are weighted by the number of cases used to calculate the group of physician’s performance rate. § 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. In calculating the na tional benchmark, groups of phys icians’ performance rates are weighted by the number of cases used to calcu late the group 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: (i) Patient safety. (ii) Patient experience. (iii) Care coordination. (iv) Clinical care.CMS-1590-P 755

(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 must have 20 or more cases for that measure. (a) Where a group of physicians has fewer than 20 cases for a measure, that measure is excluded from its domain and the remaining measur es in the domain are given equal weight. (b) Where a reliable quality of care composite or cost composite cannot be calculated, payments are not adjusted. § 414.1270 Payment adjustments. (a) Downward payment adjustments . For a group of physicians with 25 or more eligible professionals that: (1) Does not meet the value-based paymen t modifier satisfactory reporting criteria, payments for items and services under the physicia n fee schedule will be adjusted downward by 1.0 percent.CMS-1590-P 756

(2) Does meet the value-based payment modi fier satisfactory repor ting criteria, elects that their value-based payment modifier be calc ulated using a quality-tiering approach, and is determined to have poor performance (low qua lity and high costs), pa yments for items and services under the physician fee schedule are adjusted dow nward by up to 1.0 percent as specified in § 414.1275. (b) Upward payment adjustments . If a group of physicians with 25 or more eligible professionals does meet the value-based payment modifier satisfactory re porting criteria and elects that the value-based pa yment modifier be calculated us ing a quality-tiering approach, upward payment adjustments are determined based on the projected aggregate amount of downward payment adjustments determined under s ubsection (a) above and applied as specified in § 414.1275. § 414.1275 Payment modifier scoring methodology.

. (a) The value-based payment modifier amount for a group of physicians that elects the quality-tiering approach is based upon a comp arison of the composite of quality of care measures and a composite of cost measures. (b) Groups of physicians’ quality composite and cost composite are classified into high, average, and low categories based on whethe r the composites are statistically above, not different from, or below the mean composite scores. (c) The following value-based payment modifier amounts 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* +1.0x* +0.0% Average quality +1.0x* +0.0% -0.5% Low quality +0.0% -0.5% -1.0% * Groups of physicians eligible for an additi onal +1.0x if reporting Ph ysician Quality Reporting System quality measures through the GPRO using th e web-interface, claims, re gistries, or EHRs, and average beneficiary risk score in the top 25 percent of all beneficiary risk scores. (d) Groups of physicians that ha ve an attributed beneficiar y population with an averageCMS-1590-P 757

risk score in the top 25 percent of the risk scores of beneficiarie s nationwide and that satisfactorily report data on quality measures through the Physician Quality Reporting System GPRO using the web-interface, claims, registri es, or EHRs reporting mechanisms, receive a greater upward payment adjustment as follows: (1) Groups of physicians classified as high quality/low cost receive an upward adjustment of +3x (rather than +2x) and (2) Groups of physicians classified as eith er high quality/average cost or average quality/low cost receive an upward adju stment of +2x (rather than +1x). § 414.1280 Limitation of 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. § 414.1285 Inquiry process. After the dissemination of the annual Physicia n Feedback reports, a group of physicians may contact CMS to inquire about its report and the calculation of th e value-based payment modifier.

PART 415--SERVICES FURNISHED BY PHYSICIANS IN PROVIDERS,CMS-1590-P 758

SUPERVISING PHYSICIANS IN TEACH ING SETTINGS, AND RESIDENTS IN

CERTAIN SETTINGS 22. 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] 23. In §415.130(d)(1) and (d)(2), remove the reference to “December 31, 2011” and add in its place the reference to “June 30, 2012.”

PART 421--MEDICARE CONTRACTING 24. 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] 25. Subpart F is removed and reserved.

PART 423--VOLUNTARY MEDICARE PRESCRIPTION DRUG BENEFIT 26. 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). 27. Section 423.160 is amended by-- A. Revising paragraphs (a )(3)(iv), (b)(1)(ii ), and (b)(2)(ii) introductory text B. Adding paragraphs (b)(1)(iii), (b )(2)(iii), (b)(5)(i), and (b)(5)(ii).

The revisions and additions read as follows: §423.160 Standards for electronic prescribing. (a) * * * (3) * * *CMS-1590-P 759

(iv) Until November 1, 2013, 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 pr escription-related information. After January 1, 2012, entities transmitting prescripti ons or prescription-related info rmation where the prescriber is required by law to issue a prescription for a patient to a non-prescri bing provider (such as a nursing facility) that in turn forwards the pres cription to a dispenser must utilize the NCPCP

SCRIPT

* * * * * (b) * * * (1) * * * (ii) Before November 1, 2013 the standards spec ified in paragraphs (b)(2)(ii) and (b)(3)

of this section. (iii) On or after November 1, 2013, the standa rds specified in para graphs (b)(2)(ii) and (b)(3) through (b)(6) of this section. (2) * * *

(ii) The National Council for Prescripti on Drug Programs SCRIPT standard, Implementation Guide Version 10.6, approved Nove mber 12, 2008 (incorporated by reference in paragraph (c)(1)(v) of this section), or th e National Council for Prescription Drug Programs

Prescriber/Pharmacist Interface SCRIPT Standar d, Implementation Guide, Version 8, Release 1 (Version 8.1), October 2005 (incorpo rated by reference in paragraph (c)(1)(i) of this section), to provide for the communication of a prescription or prescription-related information between prescribers and dispensers, for the following:CMS-1590-P 760

* * * * * (iii) The National Council for Prescription Programs SCRIPT standard, Implementation Guide Version 10 release 6 approved Novemb er 12, 2008 (incorporated by reference in paragraph (c)(1)(i) of this secti on), to provide for the communicat ion of a prescription or related prescription related information be tween prescribers and dispensers.

* * * * * (5) * * * (i)Formulary and benefits . The National Council for Prescription Drug Programs Formulary and Benefits Standard, Implementa tion Guide, Version 1, Release 0 (Version 3.0), January 2011(incorporated by reference in paragraph (c)(1)(ii) of this section) for transmitting formulary and benefits information between prescribers and Medicare Part D sponsors. (ii) Formulary and benefits . The National Council for Prescription Drug Programs Formulary and Benefits Standard, Implementati on Guide, Version 1, Release 0 (Version 1.0), October 2005 (incorporated by reference in paragraph (c)(1)(ii) of this section) for transmitting formulary and benefits information between pres cribers and Medicare Part D sponsors; or The National Council for Prescription Drug Progr ams Formulary and Benefits Standard, Implementation Guide, Version 1, Release 0 (Version 3.0), January 2011(incorporated by reference in paragraph (c)(1)(ii) of this s ection) for transmitting formulary and benefits information between prescribers and Medicare Part D sponsors.

* * * * * 28. Subpart F, consisting of §421.500 through §421.505 is removed and reserved.

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. 1302CMS-1590-P 761

and 1395hh). 30. Section 425.308 is amended by revising pa ragraph (e) to read as follows: §425.308 Public reporting and transparency

. * * * * * (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/suppl iers who are eligible professionals, must submit the measures determined under §425.500 us ing the GPRO web interface established by CMS, to satisfactorily report on behalf of their eligible professionals for purposes of the Physician Quality Reporting System payment ad justment 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 Physician Quality Reporting System pa yment adjustment under the Shared Savings Program. (ii) Under the Shared Savings Progr am, an ACO, on behalf of its ACO providers/suppliers who are elig ible professionals, must satisf actorily report the measures determined under Subpart F of this part during the reporting period for a year, as defined inCMS-1590-P 762

paragraph (b)(6) of this section, according to the method of submission established by CMS under the Shared Savings Program for purposes of the Physician Quality Reporting System 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 Physician Quality Reporting System payment adjustment, each ACO supplier/provider who is an eligible professional, 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 pur poses of a Physician Quality Reporting System payment adjustment outside of the Medicare Shared Savings Program. (5) For eligible professionals subject to the Physician Qu ality Reporting System payment adjustment under the Medicare Shared Savings Program, the Medicare Part B Physician Fee Schedule amount for covered profe ssional services furnished during the program year is equal to the applicable percent of the Medicare Part B Physician Fee Schedule amount that would otherwise apply to such services 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:CMS-1590-P 763

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). 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.CMS-1590-P 764

* * * * *

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 PY 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: June 27, 2012

______________________ Marilyn Tavenner, Acting Administrator,

Centers for Medicare &

Medicaid Services

Approved: June 28, 2012

_____________________ Kathleen Sebelius, Secretary.

BILLING CODE 4120-01-P

[FR Doc. 2012-16814 Filed 07/06/2012 at 4:15 pm; Publication Date: 07/30/2012]