DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Medicare & Medicaid Services 42 CFR Parts 403, 405, 410, 411, 412, 413, 414, 425, 489, 495, and 498 [CMS-1612-FC]

RIN 0938-AS12 Medicare Program; Revisions to Payment Policies under the Physician Fee Schedule, Clinical Laboratory Fee Schedule, Access to Identifiable Data for the Center for Medicare

and Medicaid Innovation Models & Other Revisions to Part B for CY 2015

AGENCY: Centers for Medicare & Medicaid Services (CMS), HHS.

ACTION: Final rule with comment period.

SUMMARY: This major final rule with comment peri od addresses changes to the physician fee schedule, and other Medicare Part B payment polic ies to ensure that our payment systems are updated to reflect changes in medical prac tice and the relative value of services, as well as changes in the statute. See the Table of Contents for a listing of the specific issues addressed in

this rule.

DATES: Effective date: The provisions of this fina l rule are effective on January 1, 2015, with the exception of amendments to pa rts 412, 413, and 495 which are effective October 31, 2014

. Comment date: To be assured c onsideration, comments must be re ceived at one of the addresses provided below, no later than 5 p.m. on December 30, 2014. Compliance date: The compliance date for new data collection requireme nts in §403.904(c)(8) is January 1, 2016.

ADDRESSES: In commenting, please refer to file co de CMS-1612-FC. Because of staff and resource limitations, we ca nnot accept comments by facsimile (FAX) transmission. You may submit comments in one of four ways (please choose only one of the ways listed):CMS-1612-FC 2

1. Electronically. You may submit elec tronic comments on this regulation to www.regulations.gov . Follow the instructions for "submitting a comment." 2. By regular mail. You may mail written comments to the following address ONLY:

Centers for Medicare & Medicaid Services, Department of Health and Human Services, Attention: CMS-1612-FC, P.O. Box 8013, Baltimore, MD 21244-8013.

Please allow sufficient time for mailed comments to be received before the close of the comment period. 3. By express or overnight mail. You may send written comments to the following

address ONLY:

Centers for Medicare & Medicaid Services, Department of Health and Human Services, Attention: CMS-1612-FC, Mail Stop C4-26-05, 7500 Security Boulevard, Baltimore, MD 21244-1850. 4. By hand or courier. If you prefer, y ou may deliver (by hand or courier) your

written comments before the close of the comment period to either of the following addresses: a. For delivery in Washington, DC--

Centers for Medicare & Medicaid Services, Department of Health and Human Services, Room 445-G, Hubert H. Humphrey Building,CMS-1612-FC 3

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: Donta Henson, (410) 786-1947 for any physician payment issues not identified below. Gail Addis, (410) 786-4522, for issues related to the refinement panel. Chava Sheffield, (410) 786–2298, for issues related to practice expense methodology, impacts, the sustainable growth rate, c onscious sedation, or conversion factors. Kathy Kersell, (410) 786–2033, for issues rela ted to direct prac tice expense inputs. Jessica Bruton, (410) 786-5991, for issues rela ted to potentially misv alued services or

work RVUs.CMS-1612-FC 4

Craig Dobyski, (410) 786–4584, for issues relate d to geographic practice cost indices or malpractice RVUs. Ken Marsalek, (410) 786–4502, for issues related to telehealth services. Pam West, (410) 786-2302, for issues related to conditions for therapists in private practice or therapy caps. Ann Marshall, (410) 786-3059, for issues related to chronic care management. Marianne Myers, (410) 786-5962, for issues related to ambulance ex tender provisions. Amy Gruber, (410) 786-1542, for issues re lated to changes in geographic area designations for ambulance payment. Anne Tayloe-Hauswald, (410) 786–4546, for issues related to clinical lab fee schedule. Corinne Axelrod, (410) 786–5620, for issues relate d to Rural Health Clinics or Federally Qualified Health Centers. Renee Mentnech, (410) 786-6692, for issues rela ted to access to identifiable data for the

Centers for Medicare & Medicaid models. Marie Casey, (410) 786-7861 or Karen Reinha rdt (410) 786-0189 for issues related to local coverage determination process fo r clinical diagnostic laboratory tests. Frederick Grabau, (410) 786-0206, for issues related to private contracting/opt-out. David Walczak, (410) 786-4475, for issues re lated to payment policy for substitute physician billing arrangements (locum tenens). Melissa Heesters, (410) 786-0618, for issues re lated to reports of payments or other transfers of value to covered recipients. Alesia Hovatter, (410) 786-6861, for i ssues related to physician compare. Christine Estella, (410) 786-0485, for issues related to the physician quality reporting system. Alexandra Mugge (410) 786-4457, for issues related to EHR incentive program.CMS-1612-FC 5

Patrice Holtz, (410)786–5663, for issues related to comprehensive primary care initiative. Terri Postma, (410) 786-4169, for issues rela ted to Medicare Shared Savings Program. Kimberly Spalding Bush, (410) 786-3232, for issu es related to value-based modifier and improvements to physician feedback. Elizabeth Holland, (410) 786-1309, Medicare EHR Incentive Program (Medicare payment adjustments and hardship exceptions). Elisabeth Myers (CMS), (410) 786-4751, Medi care EHR Incentive Program (Medicare payment adjustments and hardship exceptions).

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 inst ructions 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 A. Executive Summary B. Background C. Health Information TechnologyCMS-1612-FC 6

II. Provisions of the Final Rule with Comment Period for PFS A. Resource-Based Practice Expense (PE) Relative Value Units (RVUs) B. Potentially Misvalued Services Under the Physician Fee Schedule C. Malpractice Relative Value Units (RVUs) D. Geographic Practice Cost Indices (GPCIs)

E. Medicare Telehealth Services F. Valuing New, Revised and Potentially Misvalued Codes G. Establishing RVUs for CY 2015 H. Chronic Care Management (CCM) I. Therapy Caps for CY 2015 J. Definition of Colorectal Cancer Screening Tests K. Payment of Secondary Interpretation of Images L. Conditions Regarding Permissible Practice Types for Therapists in Private Practice M. Payments for Practitioners Ma naging Patients on Home Dialysis

N. Sustainable Growth Rate III. Other Provisions of the Final Rule with Comment Period Regulation

A. Ambulance Extender Provisions B. Changes in Geographic Area Delineations for Ambulance Payment C. Clinical Laboratory Fee Schedule D. Removal of Employment Requirements fo r Services Furnished “Incident to” Rural Health Clinic (RHC) and Federally Qualified Health Center (FQHC) Visits

E. Access to Identifiable Data for the Center for Medicare and Medicaid Innovation

Models F. Local Coverage Determination Process for Clinical Diagnostic Laboratory Tests G. Private Contracting/Opt-outCMS-1612-FC 7

H. Solicitation of Comments on the Payment Policy for S ubstitute Physician Billing Arrangements I. Reports of Payments or Other Transf ers of Value to Covered Recipients J. Physician Compare Website K. Physician Payment, Efficiency, and Quality Improvements – Physician Quality Reporting System

L. Electronic Health Record (EHR) Incentive Program M. Medicare Shared Savings Program N. Value-Based Payment Modifier and Physician Feedback Program O. Establishment of the Federally Qualified Health Center Prospective Payment System (FQHC PPS) P. Physician Self-Referral Prohibition: Annual Update to the List of CPT/HCPCS

Codes Q. Interim Final Revisions to the Electro nic Health Record (EHR) Incentive Program IV. Collection of Information Requirements V. Response to Comments VI. Waiver of Proposed Rulemaking a nd Waiver of Delay in Effective Date VII. Regulatory Impact Analysis Regulations Text Acronyms In addition, because of the many organizati ons and terms to which we refer by acronym in this final rule with comment period, we are listing these acronyms and their corresponding terms in alphabetical order below: AAA Abdominal aortic aneurysms ACO Accountable care organizationCMS-1612-FC 8

AMA American Medical Association ASC Ambulatory surgical center

ATA American Telehealth Association ATRA American Taxpayer Relief Act (Pub. L. 112-240) 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) CAD Coronary artery disease CAH Critical access hospital

CBSA Core-Based Statistical Area CCM Chronic care management CEHRT Certified EHR technology

CF Conversion factor CG-CAHPS Clinician and Group Consumer Asse ssment of Healthcare Providers and Systems CLFS Clinical Laboratory Fee Schedule

CNM Certified nurse-midwife CP Clinical psychologist CPC Comprehensive Primary Care CPEP Clinical Practice Expert Panel CPT [Physicians] Current Procedural Terminology ( CPT codes, descriptions and other data only are copyright 2014 American Me dical Association. All rights

reserved. ) CQM Clinical quality measure

CSW Clinical social worker CT Computed tomographyCMS-1612-FC 9

CY Calendar year DFAR Defense Federal Acquisition Regulations DHS Designated health services

DM Diabetes mellitus DSMT Diabetes self-management training eCQM Electronic clinical quality measures

EHR Electronic health record E/M Evaluation and management EP Eligible professional eRx Electronic prescribing ESRD End-stage renal disease FAR Federal Acquisition Regulations

FFS Fee-for-service FQHC Federally qualified health center

FR Federal Register GAF Geographic adjustment factor

GAO Government Accountability Office GPCI Geographic practice cost index GPO Group purchasing organization GPRO Group practice reporting option GTR Genetic Testing Registry

HCPCS Healthcare Common Procedure Coding System HHS [Department of] Health and Human Services HOPD Hospital outpatient department HPSA Health professional shortage areaCMS-1612-FC 10

IDTF Independent diagnostic testing facility IPPS Inpatient Prospective Payment System IQR Inpatient Quality Reporting

ISO Insurance service office IWPUT Intensity of wo rk per unit of time LCD Local coverage determination MA Medicare Advantage

MAC Medicare Administrative Contractor MAP Measure Applications Partnership MAPCP Multi-payer Advanced Primary Care Practice MAV Measure application validity [process] MCP Monthly capitation payment MedPAC Medicare Payment Advisory Commission

MEI Medicare Economic Index MFP Multi-Factor Productivity MIPPA Medicare Improvements for Patient s and Providers Act (Pub. L. 110-275) MMA Medicare Prescription Drug, Improve ment and Modernization Act of 2003 (Pub. L. 108-173, enacted on December 8, 2003) MP Malpractice MPPR Multiple procedure payment reduction MRA Magnetic resonance angiography MRI Magnetic resonance imaging MSA Metropolitan Statistical Areas MSPB Medicare Spe nding per Beneficiary MSSP Medicare Shared Savings ProgramCMS-1612-FC 11

MU Meaningful use NCD National coverage determination NCQDIS National Coalition of Qual ity Diagnostic Imaging Services NP Nurse practitioner

NPI National Provider Identifier NPP Nonphysician practitioner NQS National Quality Strategy OACT CMS’s Office of the Actuary OBRA ‘89 Omnibus Budget Reconcili ation Act of 1989 (Pub. L. 101-239) OBRA ’90 Omnibus Budget Reconcilia tion Act of 1990 (Pub. L. 101- 508) OES Occupational Employment Statistics OMB Office of Management and Budget OPPS Outpatient prospective payment system OT Occupational therapy PA Physician assistant PAMA Protecting Access to Me dicare Act of 2014 (Pub. L. 113-93) PC Professional component PCIP Primary Care Incentive Payment PE Practice expense PE/HR Practice expense per hour PEAC Practice Expense Advisory Committee PECOS Provider Enrollment, Chain, and Ownership System PFS Physician Fee Schedule PLI Professional Liability Insurance PMA Premarket approvalCMS-1612-FC 12

PQRS Physician Quality Reporting System PPIS Physician Practice Expense Information Survey PT Physical therapy PY Performance year QCDR Qualified clinical data registry QRUR Quality and Resources Use Report

RBRVS Resource-based re lative value scale RFA Regulatory Flexibility Act

RHC Rural health clinic RIA Regulatory impact analysis RUC American Medical Association/Spec ialty Society Relative (Value) Update

Committee RUCA Rural Urban Commuting Area

RVU Relative value unit

SBA Small Business Administration SGR Sustainable growth rate

SIM State Innovation Model SLP Speech-language pathology SMS Socioeconomic Monitoring System SNF Skilled nursing facility TAP Technical Advisory Panel TC Technical component

TIN Tax identification number UAF Update adjustment factor UPIN Unique Physician Identification NumberCMS-1612-FC 13

USPSTF United States Preventive Services Task Force VBP Value-based purchasing VM Value-Based Payment Modifier Addenda Available Only Through th e Internet on the CMS Website The PFS Addenda along with other supporting docu ments and tables referenced in this final rule with comment period are availabl e through the Internet on the CMS website at http://www.cms.gov/Medicare/Medicare-Fee-fo r-Service-Payment/PhysicianFeeSched/PFSFederal-Regulation-Notices.html . Click on the link on the left si de of the screen titled, ‘‘PFS Federal Regulations Notices’’ for a chronological list of PFS Federal Register and other related documents. For the CY 2015 PFS final rule with comment period, refer to item CMS–1612–FC. Readers who experience any problems accessing any of the Addenda or other documents referenced in this rule and posted on the CMS website identified above should contact donta.henson1@cms.hhs.gov. CPT (Current Procedural T erminology) Copyright Notice Throughout this final rule with comment pe riod, we use CPT codes and descriptions to refer to a variety of services. We note that CPT codes and descrip tions are copyright 2013

American Medical Association. All Rights Reserved. CPT is a registered trademark of the American Medical Association (AMA). Applic able Federal Acquisition Regulations (FAR) and Defense Federal Acquisition Regulations (DFAR) apply. I. Executive Summary and Background A. Executive Summary 1. Purpose This major final rule with comment peri od revises payment polices under the Medicare Physician Fee Schedule (PFS) and makes other policy changes related to Medicare Part B payment. These changes are applicable to services furnished in CY 2015.CMS-1612-FC 14

2. Summary of the Major Provisions The Social Security Act (the Act) requires us to establish payments under the PFS based

on national uniform relative value units (RVUs) that account for th e relative resources used in furnishing a service. The Act requires that RVUs be established for three categories of resources: work, practice expens e (PE); and malpractice (MP) expe nse; and, that we establish by regulation each year’s payment amounts for all physicians’ services, in corporating geographic adjustments to reflect the variations in the cost s of furnishing services in different geographic areas. In this major final rule with comment period, we establish RVUs for CY 2015 for the PFS, and other Medicare Part B payment policies, to ensure that our payment systems are updated to reflect changes in medical practice an d the relative value of services, as well as changes in the statute. In a ddition, this final rule with comme nt period includes discussions and proposals regarding:

● Misvalued PFS Codes.

● Telehealth Services.

● Chronic Care Management Services.

● Establishing Values for New, Revised, and Misvalued Codes.

● Updating the Ambulance Fee Schedule regulations.

● Changes in Geographic Area Delineations for Ambulance Payment.

● Updating the- ++ Physician Compare Website. ++ Physician Quality Reporting System. ++ Medicare Shared Savings Program.

++ Electronic Health Reco rd (EHR) Incentive Program.

● Value-Based Payment Modifier an d the Physician Feedback Program. 3. Summary of Costs and BenefitsCMS-1612-FC 15

The Act requires that annua l adjustments to PFS RVUs ma y not cause annual estimated expenditures to differ by more than $20 million from what they would have been had the adjustments not been made. If adjustments to RVUs would cause expenditures to change by more than $20 million, we must make adjust ments to preserve budget neutrality. These adjustments can affect the distri bution of Medicare e xpenditures across specia lties. In addition, several proposed changes would affect the specialty distributi on of Medicare expenditures. When considering the combined impact of wo rk, PE, and MP RVU changes, the projected payment impacts are small for most specialties; however, the impact would be larger for a few specialties.

We have determined that this final rule w ith comment period is economically significant. For a detailed discussion of the economic impacts, see section VII. of this final rule with comment period. B. Background Since January 1, 1992, Medicare has paid for physicians’ services under section 1848 of the Act, “Payment for Physicians' Services.” Th e system relies on national relative values that are established for work, PE, and MP, which are ad justed for geographic cost variations. These values are multiplied by a conversion factor (CF) to convert the RVUs into payment rates. The concepts and methodology underlying the PFS were enacted as part of the Omnibus Budget Reconciliation Act of 1989 (Pub. L. 101-239, en acted on December 19, 1989) (OBRA ’89), and the Omnibus Budget Reconciliation Act of 1990 (Pub. L. 101-508, enacted on November 5, 1990) (OBRA ’90). The final rule published on November 25, 1991 (56 FR 59502) set forth the first fee schedule used for paym ent for physicians’ services. We note that throughout this final rule w ith comment period, unless otherwise noted, the term “practitioner” is used to describe both physicians and nonphysician practitioners (NPPs)CMS-1612-FC 16

who are permitted to bill Medicare under the PFS for services furnished to Medicare

beneficiaries. 1. Development of the Relative Values

a. Work RVUs The work RVUs established for the initial fee schedule, which was implemented on January 1, 1992, were developed with extens ive input from the physician community. A

research team at the Harvard School of Public Health developed the original work RVUs for most codes under a cooperative ag reement with the Department of Health and Human Services (HHS). In constructing the code-specific vignett es used in determining the original physician work RVUs, Harvard worked with panels of experts, both inside and outside the federal government, and obtained input from nume rous physician specialty groups. As specified in section 1 848(c)(1)(A) of the Act, the wo rk component of physicians’ services means the portion of the resources used in furnishing th e service that reflects physician time and intensity. We establish work RVUs fo r new, revised and potentially misvalued codes based on our review of information that ge nerally includes, but is not limited to,

recommendations received from the American Medical Association/Specialty Society Relative Value Update Committee (RUC), the Health Care Professionals Adviso ry Committee (HCPAC), the Medicare Payment Advisory Commission (Med PAC), and other public commenters; medical literature and comparative databases; as well as a comparison of the work for other codes within the Medicare PFS, and consultation with other physicians and hea lth care professionals within CMS and the federal government. We also asse ss the methodology and data used to develop the recommendations submitted to us by the RUC and other public commenters, and the rationale for

their recommendations. b. Practice Expense RVUsCMS-1612-FC 17

Initially, only the work RVUs were resour ce-based, and the PE and MP RVUs were based on average allowable charges. 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 required to consider general categories of expenses (such as office rent and wages of personnel, but excluding ma lpractice expenses) comprising PEs. The PE RVUs continue to represent the portion of these resources involved in furnishing PFS services. Originally, the resource-based method was to be used beginning in 1998, but section 4505(a) of the Balanced Budget Act of 1997 (Pub. L. 105-33, enacted on August 5, 1997) (BBA) delayed implementation of the resource-base d PE RVU system until January 1, 1999. In addition, section 4505(b) of the BBA provided for a 4-year transition period from the charge-based PE RVUs to the resource-based PE RVUs.

We established the resource-based PE RVUs for each physicians’ service in a final rule, published on November 2, 1998 (63 FR 58814), effective for services furnished in CY 1999. Based on the requirement to transition to a reso urce-based system for PE over a 4-year period, payment rates were not fully based upon re source-based PE RVUs until CY 2002. This resource-based system was based on two significa nt sources of actual PE data: the Clinical Practice Expert Panel (CPEP) data and the AMA’s Socioeconomic Monitoring System (SMS) data. (These data sources are described in grea ter detail in the CY 2012 final rule with comment period (76 FR 73033).) Separate PE RVUs are established for services furnished in facility settings, such as a hospital outpatient department (HOPD) or an ambulatory surgical center (ASC), and in nonfacility settings, such as a physician’s office. The nonfacility RVUs refl ect all of the direct and indirect PEs involved in furnishing a servi ce described by a partic ular HCPCS code. The difference, if any, in these PE RVUs generally results in a higher payment in the nonfacilityCMS-1612-FC 18

setting because in the facility settings some cost s are borne by the facility. Medicare’s payment to the facility (such as the out patient prospective payment system (OPPS) payment to the HOPD) would reflect costs typically in curred by the facility. Thus, payment associated with those facility resources is not made under the PFS. Section 212 of the Balanced Budget Refi nement Act of 1999 (Pub. L. 106-113, enacted on November 29, 1999) (BBRA) direct ed the Secretary of Health and Human Services (the Secretary) to establish a process under whic h we accept and use, to the maximum extent practicable and consistent with sound data practices, data collected or developed by entities and organizations to supplement the data we normally collect in determining the PE component. On May 3, 2000, we published the interim final rule ( 65 FR 25664) that set fort h the criteria for the submission of these supplemental PE survey data . The criteria were modified in response to comments received, and published in the Federal Register (65 FR 65376) as part of a November 1, 2000 final rule. The PFS fina l rules published in 2001 and 2003, respectively, (66 FR 55246 and 68 FR 63196) extended the period during which we would accept these supplemental data through March 1, 2005.

In the CY 2007 PFS final rule with comme nt period (71 FR 69624) , we revised the methodology for calculating direct PE RVUs fr om the top-down to the bottom-up methodology beginning in CY 2007. We adopted a 4-year trans ition to the new PE RVUs. This transition was completed for CY 2010. In the CY 2010 PFS final rule with comment pe riod, we updated the practice expense per hour (PE/HR) da ta that are used in the calc ulation of PE RVUs for most specialties (74 FR 61749). In CY 2010, we began a 4-year transition to the new PE RVUs using the updated PE/HR data, which was completed for CY 2013. c. Malpractice RVUs Section 4505(f) of the BBA amended section 1848(c) of the Act to require that we implement resource-based MP RVUs for se rvices furnished on or after CY 2000. TheCMS-1612-FC 19

resource-based MP RVUs were implemented in the PFS final rule with comment period published November 2, 1999 (64 FR 59380). The MP RVUs are based on commercial and physician-owned insurers’ malpractice insurance prem ium data from all the states, the District of Columbia, and Puerto Rico. For more information on MP RVUs, see section II.C. of this final rule with comment period.

d. Refinements to the RVUs Section 1848(c)(2)(B)(i) of th e Act requires that we revi ew RVUs no less often than every 5 years. Prior to CY 2013, we conducted pe riodic reviews of work RVUs and PE RVUs independently. We completed five -year reviews of work RVUs that were effective for calendar years 1997, 2002, 2007, and 2012. Although refinements to the direct PE inputs initially relied heavily on input from the RUC Practice Expense Advisory Committee (P EAC), the shifts to the bottom-up PE methodology in CY 2007 and to the use of the updated PE/HR data in CY 2010 have resulted in significant refinements to the PE RVUs in recent years.

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. With regard to MP RVUs, we completed five-year reviews of MP that were effective in

CY 2005 and CY 2010. This final rule with comment period establishes a five-year review for

CY 2015. In addition to the five-year reviews, be ginning for CY 2009, CMS, and the RUC have

identified and reviewed a numb er of potentially misvalued c odes on an annual basis based on

various identification sc reens. 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 byCMS-1612-FC 20

section 3134 of the Affordable Care Act, whic h requires the agency to periodically identify, review and adjust values for potentially misvalued codes. e. Application of Budget Neutra lity to Adjustments of RVUs

As described in section VI.C. of this final rule with comment period, in accordance with section 1848(c)(2)(B)(ii )(II) of the Act, if revisions to th e RVUs caused expenditures for the year to change by more than $20 million, we make adjustments to ensure that expenditures did not increase or decrease by more than $20 million. 2. Calculation of Payments Based on RVUs 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) to

reflect the variations in the cost s of furnishing the services. Th e GPCIs reflect the relative costs of physician work, PE, and MP in an area comp ared to the national average costs for each component. (See section II.D. of this final rule with comment period for more information about GPCIs.)

RVUs are converted to dollar amounts th rough the application of a CF, which is calculated based on a statutory formula by CMS’s Office of the Actuary (OACT). The CF for a given year is calculated using (a) the productivity-adj usted increase in th e Medicare Economic Index (MEI) and (b) the Update Adjustment Fact or (UAF), which is calculated by taking into

account the Medicare Sustainable Gr owth Rate (SGR), an annual grow th rate intended to control growth in aggregate Medicare expenditures for physicians’ services, and the allowed and actual expenditures for physicians’ services. The fo rmula for calculating th e 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. 3. Separate Fee Schedule Methodo logy for Anesthesia ServicesCMS-1612-FC 21

Section 1848(b)(2)(B) of the Ac t specifies that the fee sche dule amounts for anesthesia

services are to be based on a uniform relative value guide, with appropri ate adjustment of an anesthesia conversion factor, in a manner to as sure that fee schedule amounts for anesthesia

services are consistent with thos e for other services of comparable value. Therefore, there is a separate fee schedule methodology for anesthesia serv ices. Specifically, we establish a separate

conversion factor for anesthesia services and we u tilize the uniform relative value guide, or base units, as well as time units, to calculate the f ee schedule amounts for anesthesia services. Since anesthesia services are not valued using RVUs , a separate methodology for locality adjustments is also necessary. This involves an adjustment to the national anesthesia CF for each payment locality. 4. Most Recent Changes to the Fee Schedule The CY 2014 PFS final rule with comment period (78 FR 74230) implemented changes to the PFS and other Medicare Part B payment polic ies. It also finalized many of the CY 2013

interim final RVUs and establis hed interim final RVUs for ne w and revised codes for CY 2014 to ensure that our payment system is updated to reflect changes in medical practice, coding changes, and the relative values of services. It also implemented section 635 of the American Taxpayer Relief Act of 2012 (Pub. L. 112-240, en acted on January 2, 2013) (ATRA), which revised the equipment utilization rate assumption for advanced imaging services furnished on or after January 1, 2014. Also, in the CY 2014 PFS final rule with comment period, we announced the following for CY 2014: the total PFS update of -20.1 per cent; the initial estimate for the SGR of - 16.7 percent; and a CF of $27.2006. These figures were calculated based on the statutory provisions in effect on November 27, 2013, when the CY 2014 PFS final rule with comment period was issued.CMS-1612-FC 22

The Pathway for SGR Reform Act of 2013 (Pub. L. 113-67, enacted on December 26,

2013 ) established a 0.5 percent update to the PFS CF through March 31, 2014 and the Protecting Access to Medicare Act of 2014 (Pub. L. 113-93, enacted on April 1, 2014) (PAMA) extended this 0.5 percent update through December 31, 2014. As a result, the CF for CY 2014 that was published in the CY 2014 final rule with co mment period (78 FR 74230) was revised to $35.8228 for services furnished on or after Janua ry 1, 2014 and on or before December 31, 2014. The PAMA provides for a 0.0 percent update to the PFS for services furnished on or after January 1, 2015 and on or before March 31, 2015. The Pathway for SGR Reform Act extended through March 31, 2014 se veral provisions

of Medicare law that would have otherw ise expired on December 31, 2013. The PAMA extended these same provisions further through March 31, 2015. A list of these provisions

follows.

● The 1.0 floor on the work ge ographic practice cost index

● The exceptions process for outpatient therapy caps

● The manual medical review pr ocess for therapy services

● The application of the th erapy caps and related provision s to services furnished in

HOPDs In addition, section 220 of th e PAMA included several provisi ons affecting the valuation process for services under the PFS. Section 220(a ) of the PAMA amended section 1848(c)(2) of the Act to add a new subparagraph (M). The ne w subparagraph (M) provides that the Secretary may collect or obtain information from any eligib le professional or any other source on the resources directly or indirectly related to furnishing services for which payment is made under the PFS, and that such information may be used in the determination of relative values for services under the PFS. Such information may in clude the time involved in furnishing services; the amounts, types and prices of practice expens e inputs; overhead and accounting informationCMS-1612-FC 23

for practices of physicians and other suppliers, and any other elements that would improve the

valuation of services under the PFS. This in formation may be collected or obtained through surveys of physicians or other suppliers, prov iders of services, manuf acturers, and vendors; surgical logs, billing systems, or other prac tice or facility record s; EHRs; and any other mechanism determined appropriate by the Secretary. If we use this information, we are required

to disclose the source and us e of the information in rulemaking, and to make available aggregated information that does not disclose in dividual eligible profe ssionals, group practices, or information obtained pursuant to a nondisclosure agreement. Beginning with fiscal year 2014, the Secretary may compensate eligible pr ofessionals for submission of data. Section 220(c) of the PAMA amended section 1848(c)(2)(K)(ii) of th e Act to expand the categories of services that the Secretary is di rected to examine for th e purpose of identifying potentially misvalued codes. The nine new categories are as follows:

• Codes that account for the majority of spending under the PFS.

• Codes for services that have experienced a substantial change in the hospital length of stay or procedure time.

• Codes for which there may be a change in th e typical site of service since the code was

last valued.

• Codes for which there is a significant difference in payment for the same service

between different sites of service.

• Codes for which there may be anomalies in relative values within a family of codes.

• Codes for services where there may be efficiencies when a service is furnished at the

same time as other services.

• Codes with high intra-serv ice work per unit of time.

• Codes with high PE RVUs.CMS-1612-FC 24

• Codes with high cost supplies. (See section II.B. of this final rule with comm ent period for more information about misvalued codes.). Section 220(i) of the PAMA also requires the Secretary to make publicly available the information we considered when establishing the multiple procedure payment reduction (MPPR) policy for the professional component of advanc ed imaging procedures. The policy reduces the amount paid for the professional component wh en two advanced imaging procedures are furnished in the same session. The policy was ef fective for individual physicians on January 1, 2012 and for physicians in the same group practice on January 1, 2013. In addition, section 220 of the PAMA includes other provisio ns regarding valuation of

services under the PFS that take effect in future years. Section 220(d) of the PAMA establishes an annual target from CY 2017 through CY 2020 for reductions in PFS expenditures resulting from adjustments to relative values of misvalued services. The target is calculated as 0.5 percent of the estimated amount of expenditures under the f ee schedule for the year. If the net reduction in expenditures for the year is e qual to or greater than the target for the ye ar, the funds shall be redistributed in a budget-neutra l manner within the PFS. The amount by which such reduced expenditures exceed the target for the year shall be treated as a reduction in expenditures for the subsequent year, for purposes of determining whet her the target has or has not been met. The legislation includes an exemption from budget neutra lity of reduced expenditu res if the target is not met. Other provisions of section 220 of the PAMA include a 2-year phase-in for reductions in RVUs of at least 20 percen t for potentially misvalued codes that do not involve coding changes, and certain adjustments to the fee schedu le areas in California. These provisions will be addressed as we implement them in future rulemaking. On March 5, 2014, we submitted to MedPAC an estimate of the SGR and CF applicable to Medicare payments for physic ians’ services for CY 2015, as required by section 1848(d)(1)(E)CMS-1612-FC 25

of the Act. The actual values used to comput e physician payments for CY 2015 will be based on later data and are scheduled to be publishe d by November 1, 2014, as part of the CY 2015 PFS final rule with comment period. C. Health Information Technology The Department of Health and Human Serv ices (HHS) believes all patients, their families, and their health care providers should have consistent and timely access to patient

health information in a standardized format that can be securely exchanged between the patient, providers, and others involved in the patient’s care. (HHS A ugust 2013 Statement, “Principles and Strategies for Accelerating H ealth Information Exchange,” see http://www.healthit.gov/sites/default/file s/acceleratinghieprinciples_strategy.pdf ) HHS is committed to accelerating health information exchange (HIE) through the use of safe, interoperable health informati on technology (health IT), includi ng electronic health records (EHRs), across the broader care continuum through a number of in itiatives: (1) alignment of incentives and payment adjustments to encourag e provider adoption and optimization of health IT and HIE services through Medicare and Medi caid payment policies; (2) adoption of common standards and certification requirements for inte roperable HIT; (3) s upport for privacy and security of patient information across all HIE- focused initiatives; and (4) governance of health information. These initiatives are designed to encourage HIE among health care providers, including professionals and hos pitals eligible for the Medicare and Medicaid EHR Incentive Programs and those who are not eligible for th e EHR Incentive Programs, and are designed to improve care delivery and coordi nation across the enti re care continuum. For example, the Transition of Care Measure #2 in Stage 2 of the Medicare and Medicaid EHR Incentive Programs requires HIE to share summary records for more than 10 percent of care transitions. In addition, to increase flexibility in the Office of the National Coordinator for Health Information Technology’s (ONC) regulatory certification st ructure, ONC expressed in the 2014 EditionCMS-1612-FC 26

Release 2 final rule (79 FR 54472-73) an intent to propose fu ture changes to the ONC HIT Certification Program that would permit more effici ent certification of health IT for other health care settings, such as long-term and post-acute care and behavioral health settings. We believe that health IT that incorporates usability features and has been certified to interoperable standards can effectively and effici ently help all providers improve internal care delivery practices, support management of patie nt care across the con tinuum, and support the reporting of electronically specified clinical quality measures (eCQMs).CMS-1612-FC 27

II. Provisions of the Proposed Rule for PFS A. Resource-Based Practice Expense (PE) Relative Value Units (RVUs)

1. Overview Practice expense (PE) is the portion of th e resources used in furnishing a service that reflects the general cate gories of physician and practiti oner expenses, such as office rent and personnel wages, but excluding malp ractice expenses, as specified in section 1848(c)(1)(B) of the Act. As required by sect ion 1848(c)(2)(C)(ii) of the Act, we use a resource-based system for determining PE RVUs for each physician’s service. We develop PE RVUs by consideri ng the direct and indirect pr actice resources involved in furnishing each service. Direct expense categories include clinical labor, medical supplies, and medical equipment. Indirect expenses include administrative labor, office expense, and all other expenses. The sect ions that follow provide more detailed information about the methodology for translatin g the resources involved in furnishing each service into service-specific PE RVUs. We refer readers to the CY 2010 PFS final rule with comment period (74 FR 61743 th rough 61748) for a more detailed explanation of the PE methodology. 2. Practice Expense Methodology a. Direct Practice Expense We determine the direct PE for a specifi c service by adding the costs of the direct resources (that is, the clinical st aff, medical supplies, and medica l equipment) typically involved with furnishing that service. The costs of the re sources are calculated using the refined direct PE inputs assigned to each CPT code in our PE data base, which are generally based on our review of

recommendations received from the RUC and those provided in response to public comment periods. For a detailed explanation of the di rect PE methodology, including examples, we referCMS-1612-FC 28

readers to the Five-Year Revi ew of Work Relative Value Units under the PFS and Proposed Changes to the Practice Expense Methodology proposed notice (71 FR 37242) and the CY 2007 PFS final rule with comment period (71 FR 69629).

b. Indirect Practice Ex pense per Hour Data We use survey data on indirect PEs incurre d per hour worked in developing the indirect portion of the PE RVUs. Prior to CY 2010, we primarily used the practice expense per hour (PE/HR) by specialty that was obtained from the AMA’s Socioeconomic Monitoring Surveys (SMS). The AMA administered a new survey in CY 2007 and CY 2008, the Physician Practice Expense Information Survey (PPIS). The PPIS is a multispecialty, nationally representative, PE survey of both physicians and nonphysician pract itioners (NPPs) paid under the PFS using a survey instrument and methods highly consis tent with those used for the SMS and the supplemental surveys. The PPIS gathered information from 3,656 respondents across 51 physician specialty and health care professional groups. We believe the PPIS is the most comprehensive source of PE survey information av ailable. We used the PPIS data to update the

PE/HR data for the CY 2010 PFS for almost all of the Medicare-recognized specialties that participated in the survey. When we began using the PPIS data in CY 2010, we did not change the PE RVU methodology itself or the manner in which the PE /HR data are used in that methodology. We only updated the PE/HR data based on the new surv ey. Furthermore, as we explained in the CY 2010 PFS final rule with comment period (74 FR 61751), because of the magnitude of payment reductions for some specialties resulting from the use of the PPIS data, we transitioned its use over a 4-year period from the previous PE RVUs to the PE RVUs developed using the new PPIS data. As provided in the CY 2010 PFS final rule with comment period (74 FR 61751), the transition to the PPIS data was complete for CY 2013. Therefore, PE RVUs from CY 2013CMS-1612-FC 29

forward are developed based entirely on the PPIS data, except as noted in this section. Section 1848(c)(2)(H)(i) of th e Act requires us to use the medical oncology supplemental survey data submitted in 2003 for oncology drug admi nistration services. Therefore, the PE/HR for medical oncology, hematology, and hematology/onc ology reflects the continued use of these supplemental survey data. Supplemental survey data on independent labs from the College of American Pathologists were implemented for payments be ginning in CY 2005. Supplemental survey data from the National Coalition of Quality Diagnos tic Imaging Services (NCQDIS), representing independent diagnostic testing fac ilities (IDTFs), were blended with supplementary survey data from the American College of Radiology (ACR) and implemented for payments beginning in CY 2007. Neither IDTFs, nor independent labs, participated in the PPIS. Therefore, we continue to use the PE/HR that was develope d from their supplemental survey data. Consistent with our past pr actice, the previous indire ct PE/HR values from the supplemental surveys for these specialties were updated to CY 2006 using the MEI to put them on a comparable basis with the PPIS data. We also do not use the PPIS data for repr oductive endocrinology and spine surgery since these specialties currently are not separately recognized by Medicare, nor do we have a method

to blend the PPIS data with Medica re-recognized speci alty data. Previously, we established PE/HR values for various specialties without SMS or supplemental survey data by crosswalking them to other similar specialties to estimate a proxy PE/HR. For specialties that were part of the PPIS for which we previously used a crosswalked PE/HR, we instead used the PPIS-based PE/HR. We continue previous crosswalks for specialties that did not particip ate in the PPIS. However, be ginning in CY 2010 we changed the PE/HR crosswalk for portable x-ray suppliers from radiology to IDTF, a more appropriateCMS-1612-FC 30

crosswalk because these specialties are more similar to each other for work time. For registered dietician services, the resour ce-based PE RVUs have been calculated in accordance with the final policy th at crosswalks the specialty to the “All Physicians” PE/HR data, as adopted in the CY 2010 PFS final rule with comment period (74 FR 61752) and

discussed in more detail in th e CY 2011 PFS final rule with comment period (75 FR 73183).

c. Allocation of PE to Services To establish PE RVUs for specific services , it is necessary to establish the direct

and indirect PE associated with each service. (1) Direct Costs The relative relationship between the direct cost portions of the PE RVUs for any two services is determined by the relative rela tionship between the sum of the direct cost resources (that is, the clinical staff, medical supplies, and medical equipment) typically involved with furnishing each of the services. The costs of these resources are calculated from the refined direct PE inputs in our PE database. For example, if one service has a direct cost sum of $400 from our PE database and another serv ice has a direct cost sum of $200, the direct portion of the PE RVUs of the first service would be twice as much as the direct portion of the PE RV Us for the second service. (2) Indirect Costs

Section II.A.2.b. of this final rule with comment period describes the current data sources for specialty-specific indirect costs us ed in our PE calculations. We allocated the

indirect costs to the c ode level on the basis of the direct costs specifically associated with a code and the greater of either the clinical labor costs or the phys ician work RVUs. We also incorporated the survey data describe d earlier in the PE/HR di scussion. The general approach to developing the indirect portion of the PE RVUs is as follows:CMS-1612-FC 31

• For a given service, we use the dir ect portion of the PE RVUs calculated as previously described and the average percentage that direct costs represent of total costs (based on survey data) across the specialties that furnish the service to determine an

initial indirect allocator. In other words, the initial indirect allocator is calculated so that the direct costs equal the average percentage of direct costs of those specialties furnishing the service. For example, if the direct portion of the PE R VUs for a given service is 2.00 and direct costs, on average, represented 25 pe rcent of total costs for the specialties that furnished the service, the initial indirect allo cator would be calculated so that it equals 75 percent of the total PE RVUs. Thus, in this example, the initial indirect allocator would equal 6.00, resulting in a total PE RVUs of 8.00 (2.00 is 25 percent of 8.00 and 6.00 is 75 percent of 8.00).

• Next, we add the greater of the work RVUs or clinical labor portion of the direct portion of the PE RVUs to this initial indirect allocator. In our example, if this

service had work RVUs of 4.00 and the clinical labor portion of the direct PE RVUs was 1.50, we would add 4.00 (since the 4.00 work RV Us are greater than the 1.50 clinical labor portion) to the initial indi rect allocator of 6 .00 to get an indirect allocator of 10.00. In the absence of any further use of the surv ey data, the relative relationship between the indirect cost portions of the PE RVUs for any two services would be determined by the relative relationship between thes e indirect cost allocators. For example, if one service

had an indirect cost allocator of 10.00 and another service ha d an indirect cost allocator of 5.00, the indirect portion of the PE RVUs of the first service would be twice as great as the indirect portion of the PE R VUs for the second service.

• Next, we incorporate the specialty-s pecific indirect PE/HR data into the calculation. In our example, if, based on the su rvey data, the average indirect cost of theCMS-1612-FC 32

specialties furnishing the first service with an allocator of 10.00 was half of the average indirect cost of the specialties furnishing the second service w ith an indirect allocator of 5.00, the indirect portion of the PE RVUs of the first service would be equal to that of the

second service. d. Facility and Nonfacility Costs For procedures that can be furnished in a physician’s office, as well as in a hospital or other facility sett ing, we establish two PE RVUs: facility and nonfacility. The methodology for calculating PE RVUs is the sa me for both the facility and nonfacility RVUs, but is applied independently to yi eld two separate PE RVUs. Because in calculating the PE RVUs for services furnishe d in a facility, we do not include resources that would generally not be provided by physicians when furnishing the service in a facility, the facility PE RVUs are genera lly lower than the nonfacility PE RVUs. Medicare makes a separate payment to the faci lity for its costs of furnishing a service. e. Services with Technical Components (TCs) and Professional Components (PCs) Diagnostic services are generally compri sed of two components: a professional component (PC); and a technical component (TC). The PC and TC may be furnished independently or by different pr oviders, or they may be furnis hed together as a “global” service. When services have separately bi llable PC and TC components, the payment for the global service equals the su m of the payment for the TC and PC. To achieve this we use a weighted average of the ratio of indirect to direct costs across all the specialties that furnish the global service, TCs, and PCs; th at is, we apply the same weighted average indirect percentage factor to allocate indirect expenses to the global service, PCs, and TCs for a service. (The direct PE RVUs for the TC and PC sum to the global.) f. PE RVU MethodologyCMS-1612-FC 33

For a more detailed description of th e PE RVU methodology, we refer readers to the CY 2010 PFS final rule with comment period (74 FR 61745 through 61746). (1) Setup File First, we create a setup file for the PE methodology. The setu p file contains the direct cost inputs, the utilization for each procedure code at the specialty and facility/nonfacility place of service level, and the specialty-specific PE/HR data calculated from the surveys. (2) Calculate the Direct Cost PE RVUs Sum the costs of each direct input. Step 1: Sum the direct costs of the i nputs for each service. Apply a scaling adjustment to the direct inputs. Step 2: Calculate the aggregate pool of di rect PE costs for the current year. This is the product of the current aggregate PE (direct and indirect) RVUs, the CF, and the average direct PE percentage from the surv ey data used for calculating the PE/HR by specialty. Step 3: Calculate the aggregate pool of dir ect PE costs for use in ratesetting. This is the product of the aggregated direct costs for all services from Step 1 and the utilization

data for that service. Step 4: Using the results of Step 2 a nd Step 3, calculate a direct PE scaling adjustment to ensure that the aggregate pool of direct PE costs calcu lated in Step 3 does not vary from the aggregate pool of direct PE costs for the current year. Apply the scaling factor to the direct costs for eac h service (as calculated in Step 1). Step 5: Convert the results of Step 4 to an RVU scal e for each service. To do this, divide the results of Step 4 by the CF. No te that the actual value of the CF used inCMS-1612-FC 34

this calculation does not influence the final di rect cost PE RVUs, as long as the same CF is used in Step 2 and Step 5. Different CFs will result in different direct PE scaling factors, but this has no effect on the final di rect cost PE RVUs since changes in the CFs and changes in the associated direct s caling factors offset one another. (3) Create the Indirect Cost PE RVUs

Create indirect allocators. Step 6: Based on the survey data, calculat e direct and indirect PE percentages for each physician specialty. Step 7: Calculate direct and indirect PE percentages at the se rvice level by taking a weighted average of the results of Step 6 fo r the specialties that furnish the service. Note that for services with TCs and PCs, th e direct and indirect percentages for a given service do not vary by the PC, TC, and global service. Step 8: Calculate the service level a llocators for the indirect PEs based on the percentages calculated in Step 7. The indirect PEs are allocated based on the three components: the direct PE RVUs; the c linical PE RVUs; and the work RVUs.

For most services the indirect allocator is : indirect PE per centage * (direct PE RVUs/direct percentage) + work RVUs.

There are two situations where this formula is modified:

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

• If the clinical labor PE RVUs exceed the work RVUs (and the service is not a global service), then the indi rect allocator is: indire ct PE percentage (direct PE RVUs/direct percentage) + clinical labor PE RVUs.CMS-1612-FC 35

(Note: For global services, the indirect PE allocator is based on both the work RVUs and

the clinical labor PE RVUs. We do this to r ecognize that, for the PC service, indirect PEs will be allocated using the work RVUs, and for the TC service, indirect PEs will be allocated using the direct PE RVUs and the clin ical labor PE RVUs. This also allows the global component RVUs to equal the sum of the PC and TC RVUs.) For presentation purposes in the examples in Table 1, th e formulas were divided into two parts for each service.

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

• The second part is either the work RVU, clinical labor PE RVU, or both depending on whether the service is a global service and whether the clinical PE RVUs exceed the work RVUs (as describe d earlier in this step). Apply a scaling adjustment to the indirect allocators. Step 9: Calculate the current aggregate pool of indirect PE RVUs by multiplying the current aggregate pool of PE RVUs by the average indire ct PE percentage from the survey data. Step 10: Calculate an aggregate pool of indirect PE RVUs fo r all PFS services by adding the product of the indirect PE allo cators for a service from Step 8 and the

utilization data for that service. Step 11: Using the results of Step 9 and Step 10, calculate an indirect PE adjustment so that the aggregate indir ect allocation does not exceed the available aggregate indirect PE RVUs and apply it to indirect allocators calculated in Step 8. Calculate the indirect practice cost index. Step 12: Using the results of St ep 11, calculate a ggregate pools ofCMS-1612-FC 36

specialty-specific adjust ed indirect PE allocators for a ll PFS services for a specialty by adding the product of the adjusted indirect PE allocator for each service and the

utilization data for that service. Step 13: Using the specialty-speci fic indirect PE/HR data, calculate specialty-specific aggregate pools of indirect PE for all PFS services for that specialty by adding the product of the indirect PE/HR for th e specialty, the work time for the service, and the specialty’s utilization for the service ac ross all services furnis hed by the specialty. Step 14: Using the results of Step 12 a nd Step 13, calculate the specialty-specific indirect PE scaling factors. Step 15: Using the results of Step 14, calcu late an indirect practice cost index at the specialty level by dividing each specialty -specific indirect scaling factor by the average indirect scaling fact or for the entire PFS. Step 16: Calculate the indirect practice co st index at the service level to ensure the capture of all indirect cost s. Calculate a weighted aver age of the practice cost index values for the specialties that furnish the servi ce. (Note: For services with TCs and PCs, we calculate the indirect practice cost index across the global serv ice, PCs, and TCs. Under this method, the indirect practice cost index for a given service (for example, echocardiogram) does not vary by th e PC, TC, and global service.) Step 17: Apply the service level indirect practice cost index ca lculated in Step 16 to the service level adjusted indirect allocators calculated in Step 11 to get the indirect PE

RVUs. (4) Calculate the Final PE RVUs Step 18: Add the direct PE RVUs from Step 6 to the indirect PE RVUs from Step 17 and apply the final PE budget neutrali ty (BN) adjustment. The final PE BNCMS-1612-FC 37

adjustment is calculated by comparing the resu lts of Step 18 to the current pool of PE RVUs. This final BN adjustment is required to redistribute RVUs from step 18 to all PE RVUs in the PFS, and because certain specialties are excluded from the PE RVU calculation for ratesetting purposes, but we not e that all specialties are included for purposes of calculating the final BN adjust ment. (See “Specialties excluded from ratesetting calculation” later in this section.) (5) Setup File Information

• Specialties excluded from ratesetti ng calculation: For the purposes of calculating the PE RVUs, we exclude certain specialties, such as certain nonphysician practitioners paid at a pe rcentage of the PFS and low- volume specialties, from the calculation. These specialties are include d for the purposes of calculating the BN adjustment. They are displayed in Table 1.CMS-1612-FC 38

TABLE 1: Specialties Excluded From Rate setting Calculation Specialty Code Specialty Description 49 Ambulatory surgical center 50 Nurse practitioner 51 Medical supply company with certified orthotist 52 Medical supply company with certified prosthetist 53 Medical supply company with certified prosthetist-orthotist 54 Medical supply company not included in 51, 52, or 53. 55 Individual certified orthotist 56 Individual certified prosthetist 57 Individual certified prosthetist-orthotist 58 Medical supply company with registered pharmacist 59 Ambulance service supplier, e.g., private am bulance companies, funeral homes, etc. 60 Public health or welfare agencies 61 Voluntary health or charitable agencies 73 Mass immunization roster biller 74 Radiation therapy centers 87 All other suppliers (e.g., drug and department stores) 88 Unknown supplier/provider specialty 89 Certified clinical nurse specialist 96 Optician 97 Physician assistant A0 Hospital A1 SNF A2 Intermediate care nursing facility A3 Nursing facility, other A4 HHA A5 Pharmacy A6 Medical supply company with respiratory therapist A7 Department store B2 Pedorthic personnel B3 Medical supply company with pedorthic personnel

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

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

• Identify professional and technical serv ices not identified under the usual TC and 26 modifiers: Flag the services that ar e PC and TC services, but do not use TC andCMS-1612-FC 39

26 modifiers (for example, elec trocardiograms). This flag associates the PC and TC with the associated global code for use in creati ng the indirect PE RVUs . For example, the professional service, CPT code 93010 (Electro cardiogram, routine EC G with at least 12 leads; interpretation and report only), is associated with the global service, CPT code 93000 (Electrocardiogram, routine ECG with at least 12 leads; with interpretation and report).

• Payment modifiers: Payment modifiers ar e accounted for in the creation of the file consistent with current payment policy as implemented in claims processing. For example,

services billed with the assist ant at surgery modifier are paid 16 percent of the PFS amount for that service; therefore, the uti lization file is modified to only account for 16 percent of any service that contains the assistant at surgery m odifier. Similarly, for t hose services to which volume adjustments are made to account for the pa yment modifiers, time adjustments are applied as well. For time adjustments to surgical services, the intraoperative portion in the work time file is used; where it is not present, the intraope rative percentage from the payment files used by contractors to process Medicare claims is used instead. Where neither is available, we use the payment adjustment ratio to adjust the time accord ingly. Table 2 details the manner in which the modifiers are applied.CMS-1612-FC 40

TABLE 2: Application of Paymen t Modifiers to Utilization Files Modifier Description Volume Adjustment Time Adjustment 80,81,82 Assistant at Surgery 16% Intraoperative portion AS Assistant at Surgery – Physician Assistant 14% (85% * 16%) Intraoperative portion 50 or LT and RT Bilateral Surgery 150% 150% of work time 51 Multiple Procedure 50% Intraoperative portion 52 Reduced Services 50% 50% 53 Discontinued Procedure 50% 50% 54 Intraoperative Care only Preoperative + Intraoperative Percentages on the payment files used by Medicare contractors to process Medicare claims Preoperative + Intraoperative portion

55 Postoperative Care only Postoperative Percentage on the payment files used by Medicare contractors to process Medicare claims Postoperative portion

62 Co-surgeons 62.5% 50% 66 Team Surgeons 33% 33%

We also make adjustments to volume and time that correspond to other payment rules, including special multiple procedure endoscopy ru les and multiple procedure payment reductions (MPPR). We note that section 1848(c)(2)(B)(v) of the Act exem pts certain reduced payments for multiple imaging procedures and multiple th erapy services from the BN calculation under section 1848(c)(2)(B)(ii)(II ) of the Act. These MPPRs are not included in the development of

the RVUs. For anesthesia services, we do not apply adjustments to volume since the average allowed charge is used when simulating RVUs, and therefore, includes all adjustments. A time adjustment of 33 percent is made only for medical direction of two to four casesCMS-1612-FC 41

since that is the only situation where time units are duplicative.

● Work RVUs: The setup file contains th e work RVUs from this final rule with comment period. (6) Equipment Cost Per Minute The equipment cost per minute is calculated as: (1/(minutes per year * usage)) * price * ((interest rate/(1-(1/((1 + interest rate)^ life of equipment)))) + maintenance)

Where: minutes per year = maximum minutes per ye ar if usage were continuous (that is, usage = 1); generally 150,000 minutes. usage = variable, see discussion below. price = price of the particular piece of equipment. life of equipment = useful life of th e particular piece of equipment. maintenance = factor for maintenance; 0.05. interest rate = variable, see discussion below. Usage: We currently use an equipment utilization rate assu mption of 50 percent for most equipment, with th e exception of expensive diagnos tic imaging equipment, for which we use a 90 percent assumption as requi red by Section 1848(b)(4)(C) of the Act.

Maintenance: This factor for mainte nance was proposed and finalized during rulemaking for CY 1998 PFS (62 FR 33164). Seve ral stakeholders ha ve suggested that this maintenance factor assumption should be variable. We solicited comments regarding reliable data on maintenance costs that vary for particular equipment items. We received several comments about variable maintenance costs, which we will consider in future rulemaking. We note, however, that we do not believe that high-level summary dataCMS-1612-FC 42

from informal surveys constitutes reliable data. Rather than assertions that a particular maintenance rate is typical, multiple invoi ces containing equipment prices that are accompanied by maintenance contracts would provide support for a maintenance cost other than our currently assumed 5 percent. We continue to seek reliable data about variable maintenance costs, as we consider adjustme nts to our methodology to

accommodate variable maintenance costs. Per-use Equipment Costs: Several stakehol ders have also suggested that our PE methodology should incorporate usage fees and other per-use equipment costs as direct costs. We also solicited comment on adjust ing our cost formula to include equipment costs that do not vary based on the equipment time. We received a comment that addressed how to incorporate usage fees a nd other per-use equipm ent costs into our methodology, and received several comments th at addressed how we should reclassify the anomalous supply inputs removed from the direct PE database. We will consider these comments in future rulemaking, includ ing the way these anomalous supply inputs fit in to any future proposals related to per-use costs.

Interest Rate : In the CY 2013 final rule with comment period (77 FR 68902), we updated the interest rates used in developing an equipment cost per minute calculation.

The interest rate was based on the Sma ll Business Administration (SBA) maximum interest rates for different categories of lo an size (equipment cost) and maturity (useful life). The interest rates are listed in Ta ble 3. (See 77 FR 68902 for a thorough discussion of this issue.)CMS-1612-FC 43

TABLE 3: SBA Maximum Interest Rates

Price Useful Life Interest Rate <$25K <7 Years 7.50% $25K to $50K <7 Years 6.50% >$50K <7 Years 5.50% <$25K 7+ Years 8.00% $25K to $50K 7+ Years 7.00% >$50K 7+ Years 6.00%CMS-1612-FC 44TABLE 4: CALCULATION OFPE RVUS UNDER METHODOLOGY FOR SELECTED CODESStep Source Formula 99213Officevisit, estNonfacility33533CABG,arterial,singleFacility71020Chest xrayNonfacility71020-TCChest xray,Nonfacility71020-26Chest xray,Nonfacility93000ECG,complete,Nonfacility93005ECG,tracingNonfacility93010ECG,reportNonfacility(1) Laborcost (Lab)Step 1 AMA13.3277.525.745.74-5.105.10-(2) Supplycost (Sup)Step 1 AMA2.987.340.530.53-1.191.19-(3)Equipmentcost (Eqp)Step 1 AMA0.170.586.926.92-0.090.09-(4) Directcost (Dir)Step 1 =(1)+(2)+(3)16.4885.4513.1913.19-6.386.38-(5) Directadjustment(Dir. Adj.)Steps 2-4 Seefootnote*0.58980.58980.58980.58980.58980.58980.58980.5898(6)AdjustedLaborSteps 2-4 =Labor *Dir Adj=(1)*(5)7.8645.723.393.39-3.013.01-(7)AdjustedSuppliesSteps 2-4 =Eqp * DirAdj=(2)*(5)1.764.330.310.31-0.700.70-(8)AdjustedEquipmentSteps 2-4 =Sup * DirAdj=(3)*(5)0.100.344.084.08-0.050.05-(9)AdjustedDirectSteps 2-4 =(6)+(7)+(8)9.7250.407.787.78-3.773.77-(10)ConversionStep 5 PFS35.8235.8235.8235.8235.8235.8235.8235.82CMS-1612-FC 45Step Source Formula 99213Officevisit, estNonfacility33533CABG,arterial,singleFacility71020Chest xrayNonfacility71020-TCChest xray,Nonfacility71020-26Chest xray,Nonfacility93000ECG,complete,Nonfacility93005ECG,tracingNonfacility93010ECG,reportNonfacilityFactor (CF)(11) Adj.labor costconvertedStep 5 =(Lab * DirAdj)/CF=(6)/(10)0.221.280.090.09-0.080.08-(12) Adj.supply costconvertedStep 5 =(Sup * DirAdj)/CF=(7)/(10)0.050.120.010.01-0.020.02-(13) Adj.equipmentcostconvertedStep 5 =(Eqp * DirAdj)/CF=(8)/(10) -0.010.110.11-- - -(14) Adj.direct costconvertedStep 5 =(11)+(12)+(13)0.271.410.220.22-0.110.11-(15) WorkRVUSetupFilePFS0.9733.750.22-0.220.17-0.17(16)Dir_pctSteps 6,7 Surveys0.250.170.290.290.290.290.290.29(17)Ind_pctSteps 6,7 Surveys0.750.830.710.710.710.710.710.71(18) Ind.Alloc.Formula(1st part)Step 8 See Step 8 ((14)/(16)*(17)((14)/(16)*(17)((14)/(16)*(17)((14)/(16)*(17)((14)/(16)*(17)((14)/(16)*(17)((14)/(16)*(17)((14)/(16)*(17)(19) Ind.Alloc.(1stpart)Step 8 See 180.826.670.530.53-0.260.26-(20) Ind.Alloc.FormulaStep 8 See Step 8 (15) (15) (15+11) (11) (15) (15+11) (11) (15)CMS-1612-FC 46Step Source Formula 99213Officevisit, estNonfacility33533CABG,arterial,singleFacility71020Chest xrayNonfacility71020-TCChest xray,Nonfacility71020-26Chest xray,Nonfacility93000ECG,complete,Nonfacility93005ECG,tracingNonfacility93010ECG,reportNonfacility(2nd part)(21) Ind.Alloc.(2ndpart)Step 8 See 200.9733.750.310.090.220.250.080.17(22)IndirectAllocator(1st + 2nd)Step 8 =(19)+(21)1.7940.420.840.620.220.510.340.17(23)IndirectAdjustment (Ind. Adj.)Steps 9-11SeeFootnote**0.38130.38130.38130.38130.38130.38130.38130.3813(24)AdjustedIndirectAllocatorSteps 9-11=Ind Alloc* Ind Adj0.6815.410.320.240.080.200.130.06(25) Ind.PracticeCost Index(IPCI)Steps 12-161.070.750.990.990.990.910.910.91(26)AdjustedIndirectStep 17 = Adj.IndAlloc * PCI=(24)*(25)0.7311.590.320.240.080.180.120.06(27) FinalPE RVUStep 18 =(Adj Dir +Adj Ind) *Other Adj=((14)+(26))* Other Adj)1.0113.040.540.460.080.290.230.06Note: PE RVUs in Table 5, row 27, may not match Addendum B due to rounding.*The direct adj = [current pe rvus * CF * avg dir pct]/[sum direct inputs] =[step2]/[step3]**The indirect adj = [current pe rvus * avg ind pct]/[sum of ind allocators] =CMS-1612-FC 47Step Source Formula 99213Officevisit, estNonfacility33533CABG,arterial,singleFacility71020Chest xrayNonfacility71020-TCChest xray,Nonfacility71020-26Chest xray,Nonfacility93000ECG,complete,Nonfacility93005ECG,tracingNonfacility93010ECG,reportNonfacility[step9]/[step10]Note: The use of any particular conversion factor (CF) in Table5 to illustrate the PE Calculation has no effect on the resulting RVUs.Note: The Other Adjustment includes an adjustment for the equipment utilization change.CMS-1612-FC 48

3. Changes to Direct PE I nputs for Specific Services In this section, we discuss other CY 2015 revisi ons related to direct PE inputs for specific services. The final direct PE inputs are incl uded in the final rule CY 2015 direct PE input database, which is availabl e on the CMS website under downloads for the CY 2015 PFS final rule with comment period at http://www.cms.gov/Medicare/Medicare-Fee-for-ServicePayment/PhysicianFeeSched/PFS-Fe deral-Regulation-Notices.html

. a. RUC Recommendation for Monitori ng Time following Moderate Sedation

We received a recommendation from the RU C regarding appropriate clinical labor minutes for post-procedure moderate sedation monitoring and post-procedure monitoring. The

RUC recommended 15 minutes of RN time fo r one hour of monitoring following moderate sedation and 15 minutes of RN time per hour for post-procedure mon itoring (unrelated to moderate sedation). For 17 procedures listed in Table 5, the recommended clinical labor minutes

differed from the clinical labor minutes in the direct PE database. We proposed to accept, without refinement, the RUC recommendation to adju st these clinical labor minutes as indicated in Table 5 as “Change to Clinical Labor Time.”CMS-1612-FC 49

TABLE 5: Codes with Changes to Post-Pro cedure Clinical Labor Monitoring Time

CPT Code Current Monitoring Time (Min) RUC Recommended Total Post-Procedure Monitoring Time (Min) Change to Clinical Labor Time (Min) 32553 30 60 30 35471 21 60 39 35475 60 30 -30 35476 60 30 -30 36147 18 30 12 37191 60 30 -30 47525 6 15 9 49411 30 60 30 50593 30 60 30 50200 15 60 45 31625 20 15 -5 31626 25 15 -10 31628 25 15 -10 31629 25 15 -10 31634 25 15 -10 31645 10 15 5 31646 10 15 5

Comment: We received two comments s upporting our proposal to accept the RUC recommendation, without re finement, to adjust the c linical labor minutes as

indicated in Table 5. One commenter noted that the RUC recommendation was a more accurate reflection of the monitoring time, particularly for codes 50593 (Ablation, renal tumor(s), unilateral, percutaneous, cryothe rapy) and 50200 (Renal bi opsy; percutaneous, by trocar or needle), than the current time. Response: We appreciate commenters ’ support for our proposal. After consideration of comments received, we ar e finalizing our proposal to accept, without refinement, the RUC recommendation to adjust the clinical labor minutes as indicated in Table 5 as “Change to Clinical Labor Time.”

b. RUC Recommendation for Standa rd Moderate Sedation PackageCMS-1612-FC 50

We received a RUC recommendation to modify PE inputs included in the standard moderate sedation package. Specifically, the RUC indicated that several sp ecialty societies have pointed to the need for a stretc her during procedures for which m oderate sedation is inherent in the procedure. Although the RUC did not reco mmend that we make changes to PE inputs for codes at this time, the RUC indicated that its fu ture recommendations would include the stretcher as a direct input for procedures including moderate sedation.

The RUC recommended three scenarios that it would use in the future to allocate the equipment time for the stretcher based on the pr ocedure time and whether the stretcher would be available for other patients to use during a portion of the procedure. Although we appreciate the

RUC’s attention to the differences in the time re quired for the stretcher ba sed on the time for the procedure, we believe that one of the purposes of standard PE input packages is to reduce the complexity associated with assigning appropriate PE inputs to individual procedures while, at the same time, maintaining relativity between procedur es. Since we generally allocate inexpensive equipment items to the entire service period when they are likely to be unavailable for another use during the full service period, we believe it is preferable to treat the stretcher consistently across services. Therefore, we proposed to modi fy the standard moderate sedation input package to include a stretcher for the same length of tim e as the other equipment items in the moderate sedation package. The revised moderate sedation input package will be app lied to relevant codes as we review them through future notice and comment rulemaking. In seeking comments on the proposal, we stated that it would be useful to hear stakeholders’ views and the reasoning behind them on this issue, especially from those who th ink that the stretcher, as expressed through the allocation of equipment minutes, should be alloca ted with more granularity than the equipment

costs that are allocated to other similar items.CMS-1612-FC 51

Comment: We received comments supporting ou r proposal to add the stretcher to the moderate sedation package, includ ing support to include the stretc her for the same length of time as the other equipment items included in the m oderate sedation package since it is used by the patient for the duration of their recovery and not available to other patients during that time.

Response: We appreciate the commente rs’ support for our proposal. After consideration of comments received, we are fi nalizing our proposal to add the stretcher to the moderate sedation package for the same length of time as the other equipment items in the moderate sedation package. We note that we will not apply this change retroactively, but will make the change to the moderate sedation package for codes being finalized for 2015, as well as interim final c odes for 2015. For a detailed discussion of the specific codes impacted by this change, we refer readers to sections II.F. of this final rule with comment period. c. RUC Recommendation for Migration from Film to Digital Practice Expense Inputs The RUC provided a recommendation regard ing the PE inputs for digital imaging services. Specifically, the RUC recommended that we remove a list of supply and equipment items associated with film technology since thes e items are no longer a typical resource input;

these items are detailed in Table 6. The RUC al so recommended that the Picture Archiving and Communication System (PACS) equipment be incl uded for these imaging services since these items are now typically used in furnishing imag ing services. We received a description of the PACS system as part of the recommendation, whic h included both items that appear to be direct

PE items and items for which indirect PE RVUs are allocated in the PE methodology. As we have previously indicated, items which are not clinical labor, medical supplies, or medical equipment, or are not individually allocable to a particular patient for a particular procedure, are not categorized as direct costs in the PE methodology. Since we did not receive any invoices forCMS-1612-FC 52

the PACS system prior to the proposed rule, we were unable to determine the appropriate pricing to use for the inputs. We proposed to accept the RUC recommendation to remove the film supply and equipment items, and to allocate minut es for a desktop computer (ED021) as a proxy for the PACS workstation as a direct expense. Specifically, for the 31 services that already contain ED021 (computer, desktop, w-monitor), we proposed to retain the time that is currently included in the direct PE input database. For the remaining services that are valued in the nonfacility setting, we proposed to allocate the full clinical labor intraservice time to ED021, except for codes without clinical labor, in whic h case we proposed to a llocate the intraservice work time to ED021. For services valued only in the facility setting, we proposed to allocate the post-service clinical la bor time to ED021, since th e film supply and/or equipment inputs were previously associated with the post-service period.CMS-1612-FC 53

TABLE 6: RUC-Recommended Supply a nd Equipment Items Removed for Digital Imaging Services CMS Code Description SK013 computer media, dvd SK014 computer media, floppy disk 1.44mb SK015 computer media, optical disk 128mb SK016 computer media, optical disk 2.6gb SK022 film, 8inx10in (ultrasound, MRI) SK025 film, dry, radi ographic, 8in x 10in SK028 film, fluoroscopic 14 x 17 SK033 film, x-ray 10in x 12in SK034 film, x-ray 14in x 17in SK035 film, x-ray 14in x 36in SK037 film, x-ray 8in x 10in SK038 film, x-ray 8in x 10in (X-omat, Radiomat) SK086 video tape, VHS SK089 x-ray developer solution SK090 x-ray digitalization separator sheet SK091 x-ray envelope SK092 x-ray fixer solution SK093 x-ray ID card (flashcard) SK094 x-ray marking pencil SK098 film, x-ray, laser print SM009 cleaner, x-ray cassette-screen ED014 computer workstati on, 3D reconstruction CT-MR ED016 computer worksta tion, MRA post processing ED023 film processor, PET imaging ED024 film processor, dry, laser ED025 film processor, wet ED027 film processor, x-omat (M6B) ER018 densitometer, film ER029 film alternator (motorized film viewbox) ER067 x-ray view box, 4 panel

We note that the RUC exempted certain proc edures from its recommendation because (a) the dominant specialty indicated th at digital technology is not ye t typical or (b) the procedure only contained a single input associated with film technology, and it was determined that the sharing of images, but not actual imaging, may be involved in the service. However, we do not believe that the most appropriate approach in establishing relative values for services thatCMS-1612-FC 54

involve imaging is to exempt services from the tr ansition from film to digital PE inputs based on information reported by individua l specialties. Although we unders tand that the migration from film technology to digital technol ogy may progress at different p aces for particular specialties, we do not have information to suggest that the mi gration is not occurring for all procedures that require the storage of images. Just as it was ap propriate to use film inputs as a proxy for some services for which digital input s were typical pending these ch anges in the direct PE input database, we believe it is appropr iate to use digital inputs as a proxy for the services that may still use film, pending their mi gration to digital technology. In addition, since the RUC

conducted its collection of informa tion from the specialties over several years, we believe the migration process from film to digital inputs has likely continued ove r the time period during which the information was gathered, and that th e digital PE inputs will reflect typical use of technology for most if not all of these services before the change to digital inputs would take effect beginning January 1, 2015. We noted that we believed that, for the sake of relativity, we should remove the equipment and supply inputs noted below from a ll procedures in the direct PE database, including those listed in Tabl e 7. We sought comment on whet her the computer workstation, which we proposed to use as a proxy for the PACS workstation, is the appropriate input for the services listed in Table 7, or whether an alternative input is a more appropriate reflection of

direct PE costs.CMS-1612-FC 55

TABLE 7: Codes Containing Film Inputs But Excluded From the RUC Recommendation HCPCS Short Descriptor

21077 Prepare face/oral prosthesis 28293 Correction of bunion 61580 Craniofacial approach skull 61581 Craniofacial approach skull 61582 Craniofacial approach skull 61583 Craniofacial approach skull 61584 Orbitocranial approach/skull 61585 Orbitocranial approach/skull 61586 Resect nasopharynx skull 64517 N block inj hypogas plxs 64681 Injection treatment of nerve 70310 X-ray exam of teeth 77326 Brachytx isodose calc simp 77327 Brachytx isodose calc interm 77328 Brachytx isodose plan compl 91010 Esophagus motility study 91020 Gastric motility studies 91034 Gastroesophageal reflux test 91035 G-esoph reflx tst w/electrod 91037 Esoph imped function test 91038 Esoph imped funct test > 1hr 91040 Esoph balloon distension tst 91120 Rectal sensation test 91122 Anal pressure record 91132 Electrogastrography 91133 Electrogastrography w/test 92521 Evaluation of speech fluency 92523 Speech sound lang comprehend HCPCS Short Descriptor 92524 Behavioral qualit analys voice 92601 Cochlear implt f/up exam <7 92603 Cochlear implt f/up exam 7/> 92611 Motion fluoroscopy/swallow 92612 Endoscopy swallow tst (fees) 92614 Laryngoscopic sensory test 92616 Fees w/laryngeal sense test 95800 Slp stdy unattended 95801 Slp stdy unatnd w/anal 95803 Actigraphy testing 95805 Multiple sleep latency test 95806 Sleep study unatt&resp efft 95807 Sleep study attended 95808 Polysom any age 1-3> param 95810 Polysom 6/> yrs 4/> param 95811 Polysom 6/>yrs cpap 4/> parm 95812 Eeg 41-60 minutes 95813 Eeg over 1 hour 95829 Surgery electrocorticogram 95950 Ambulatory eeg monitoring 95953 Eeg monitoring/computer 95954 Eeg monitoring/giving drugs 95955 Eeg during surgery 95956 Eeg monitor technol attended 95957 Eeg digital analysis 96904 Whole body photography G0270 Mnt subs tx for change dx G0271 Group mnt 2 or more 30 minsCMS-1612-FC 56

Finally, we noted that the RUC recommenda tion also indicated that, given the laborintensive nature of reviewing a ll clinical labor tasks associated with film technology, these times

would be addressed as these code s are reviewed. We agreed w ith the RUC that reviewing and adjusting the times for each code would be difficu lt and labor-intensive sin ce the direct PE input database does not allow for a comprehensive ad justment of the clinical labor time based on changes in particular clinical la bor tasks. To make broad adjust ments such as this across codes,

the PE database would need to contain the time associated with individual clinical labor tasks rather than reflecting only the sum of times for the pre-service period, service period, and postservice period, as it does now. We recognized this situation pres ents a challenge in implementing RUC recommendations such as this one, and makes it difficult to understand the

basis of both the RUC’s recommended clinical labor times and our refinements of those recommendations. Therefore, we stated that we were considering revising the direct PE input

database to include task-level clinical labor time information for every code in the database. As an example, we referred readers to the supporting data files for the direct PE inputs, which include public use files that displa y clinical labor times as allocat ed to each individual clinical labor task for a sample of procedures. We displa yed this information as we attempt to increase the transparency of the direct PE database. We stated that we hoped that this modification would enable us to more accurately a llocate equipment minutes to c linical labor tasks in a more

consistent and efficient manner. Given the numbe r of procedures and th e volume of information involved, we sought comments on the feasibility of this approach. We note that we did not propose to make any changes to PE inputs for CY 2015 based on th is modification to the design of the direct PE input database.

As discussed in section II.G. of this fina l rule with comment period, some of the RUC

recommendations for 2015 included film items as practice expense inputs. For existing codes,CMS-1612-FC 57

the database from the proposed rule already in cluded the PACS workstation proxy. However, for new services, as with the current items in the da tabase, we have replaced the film items with the PACS workstation proxy. The codes affected by this change are listed in Table 8.

TABLE 8: 2015 Codes Affected by Removal of Film Inputs

HCPCS Short Descriptor HCPCS Short Descriptor

22510 Perq cervicothoracic inject 93314 Echo transesophageal 22511 Perq lumbosacral injection 93320 Doppler echo exam heart 22513 Perq vertebral augmentation 93321 Doppler echo exam heart 22514 Perq vertebral augmentation 93325 Doppler color flow add-on 62302 Myelography lumbar injection 93880 Extracranial bilat study 62303 Myelography lumbar injection 93882 Extracranial uni/ltd study 62304 Myelography lumbar injection 93886 Intracranial complete study 62305 Myelography lumbar injection 93888 Intracranial limited study 71275 Ct angiography chest 93895 Carotid intima atheroma eval 72191 Ct angiograph pelv w/o&w/dye 93925 Lower extremity study 72240 Myelography neck spine 93926 Lower extremity study 72255 Myelography thoracic spine 93930 Upper extremity study 72265 Myelography l-s spine 93931 Upper extremity study 72270 Myelogphy 2/> spine regions 93970 Extremity study 74174 Ct angio abd&pelv w/o&w/dye 93971 Extremity study 74175 Ct angio abdom w/o & w/dye 93975 Vascular study 74230 Cine/vid x-ray throat/esoph 93976 Vascular study 76942 Echo guide for biopsy 93978 Vascular study 93312 Echo transesophageal 93979 Vascular study

Comment: We received many comments on our proposal to remove the equipment and supply inputs associated w ith film technology from the direct PE database. In general, commenters supported our proposal to remove the film inputs from

the direct PE database. Some commenters supported our use of the desktop computer as a proxy for the PACS workstation, but other commenters opposed using this item as a proxy. Commenters opposed to using the deskto p computer as the proxy item stated that the PACS workstation was significantly more expensive and included greater functionality than a deskt op computer. Some commenters opposed our proposal toCMS-1612-FC 58

maintain the current equipment time allocated to the computer desktop for the 31 services that already included this equipment item, sugge sting that it was inco rrect to eliminate the film inputs without proportionately incr easing the proxy time for ED021. Some commenters requested a delay in implementa tion until stakeholders provide invoices or otherwise work with CMS to identify pri ces for the PACS items. Some commenters suggested CMS should develop a means to allo cate digital technology costs to individual services, even if it is difficult to do so. A nother commenter explaine d that it is difficult for stakeholders to obtain invoices that disp lay prices for individual items, such as the PACS workstation, since the pr ice of the particular items is often bundled with other related equipment and services. Many commenters urged CMS to work with stakeholders to obtain invoices, while othe r commenters requested that CMS accept the RUC recommendation regardi ng the PACS workstation. Response: We appreciate commenters’ s upport for our proposal to incorporate

the transition from film to di gital imaging technology into th e direct PE input database. With regard to the pricing of the PACS work station, as with all i nputs, we would prefer to use actual paid invoices to establish th e input price. However, in the absence of invoices demonstrating the actual cost, we believe th at use of a proxy to price the appropriate inputs, in this case the PACS work station, is preferable to continuing to use inputs that we know are no longe r typical. We made the prop osal to use the computer, desktop, w-monitor (ED021), priced at $2,501, as a proxy based on our assessment of

similar resource costs between the item and the PACS workstation. Although some

commenters stated that the item was not an appropriate proxy, these commenters did not provide any evidence to indicate that the reso urce costs are not similar or to suggest a more appropriate proxy. Nor were any pa id invoices submitted. Absent suchCMS-1612-FC 59

information, we continue to believe that us ing the proxy item is the best approach to incorporate the direct PE cost of the digital imaging technology. With regard to the 31 services that al ready included the desktop computer as an equipment input, we will include the de sktop computer as a proxy for the PACS workstation using the same methodology as fo r the services that did not previously contain the desktop computer. To clearly differentiate the desktop computer proxy from the desktop computer currently included in these services , and to facilitate accurate replacement of this input when we do receiv e pricing information, we will create a new equipment item called “desktop computer (pr oxy for PACS workstation),” which will be allocated to each procedure usi ng the methodology described above. Comment: Some commenters opposed our removal of the film inputs from

services that were not in cluded in the RUC recommenda tion, but did not provide a rationale for their opposition. Response: For the reasons we explaine d in making the proposal and reiterate above, we continue to believe th at it is appropriate to remove these items from the direct

PE database. Comment: Some commenters provided speci fic suggestions regarding the use of digital inputs should CMS d ecide to move forward with the proposal. Commenters requested that for portable x-ray services , CMS include a flat plate receptor/image capture plate to capture the image, specia lized software to process the image, and multiple high definition monitors used by the interpreting radiologist. Commenters provided an invoice for the image capture plat e at a price of $25,600 i ndicating that this item replaces the film as the media to record the image. Response: We appreciate that commente rs provided us with an invoice for theCMS-1612-FC 60

image capture plate. However, services furnished by portable x-ray providers are reported using the same procedure codes as services provided using fixed machines. Since the typical x-ray servic e is furnished using fixed equipment, we are not including the image capture plate that is associated w ith portable equipment as an input for the imaging procedure codes. We also do not be lieve that high definition monitors used by the interpreting radiologist are appropriatel y included in the tec hnical component of imaging procedures; rather, these are indir ect costs associated with the professional component of the service. Therefore, we ar e not including the high definition monitors as an input for these services. Finally, to dete rmine whether the software is appropriately categorized as a direct PE i nput, we need more information about the functionality of the software, and whether it is used in furnishi ng the typical x-ray serv ice (including services furnished using fixed machinery). Until we have information that supports the inclusion of this item as a direct cost, we will not include the software for x-ray services. Comment: Commenters were supportive of the increased transparency with regard to the direct PE inputs, but several co mmenters suggested that there ma y be more feasible approaches

to break out the individual clin ical labor tasks associ ated with each portion of the service (preservice period, service period, and post-service pe riod). The RUC suggested that we post all PE worksheets and supporting materials in code-ord er on our website. Other commenters did not suggest a specific alternativ e approach to providing detail for th e individual clinic al labor tasks. Response: We appreciate the RUC’s sugge stion regarding the posting of the PE worksheets, but we do not believe that this would enable us to accomplish a comprehensive cross-code analysis and refinement to clinical labor times within the direct PE input database to increase consistency for identical clinical labor tasks between codes. Since we did not receive other suggestions from commenters on an appro ach to break out the i ndividual clin ical laborCMS-1612-FC 61

tasks associated with each servi ce period to enable us to conduct the necessary analysis, we will pursue the approach described in the proposed rule. We will consider the comments submitted

and continue to work with interested stakeholders regarding the best approaches to displaying the supporting files. We note that public use files continue to be availa ble in the same format as in previous years, but that additional public use f iles now display the clinical labor tasks for each service period, providing greater transparency and enabling compar isons across codes. We note

that we have refined the file structure based on comments, and we continue to seek input on whether there are additional or alternative ways to display this information to enhance its clarity, and note that there are challenges inherent in the display of this information in a two-dimensional format. We refer readers to the public use f iles available on the CMS website under downloads for the CY 2015 PFS final rule with comment period at http://www.cms.gov/Medicare/MedicareFee-for-Service-Payment/PhysicianFeeSched /PFS-Federal-Regulation-Notices.html d. Inputs for Digital Mammography Services Mammography services are currently repor ted and paid using both CPT codes and Gcodes. To meet the requirements of the Medi care, Medicaid, and SCHI P Benefits Improvement and Protection Act of 2000 (BIPA), we establishe d G-codes for use beginning in CY 2002 to pay for mammography services using new digita l technologies (G0202 screening mammography digital; G0204 diagnostic mammography digital; G0206 diagnostic mammography digital). We continued to use the CPT codes for mammograp hy services furnished using film technology (77055 (Mammography; unilate ral); 77056 (Mammography; b ilateral); 7 7057 (Screening mammography, bilateral (2-vie w film study of each breast)). As we discussed previously in this section, the RUC has recommended that all im aging codes, including mammography, be valued using digital rather than film i nputs because the use of film is no longer typical. A review of

Medicare claims data shows that the ma mmography CPT codes are billed extremelyCMS-1612-FC 62

infrequently, and that the G-c odes are billed for the vast majority of mammography claims, confirming the RUC’s conclusion th at the typical service uses di gital technology. As such, we

stated that we do not believe there is a reason to continue the separate CPT codes and G-codes for mammography services since bot h sets of codes would have the same values when priced based upon the typical digital technology. Accordingly, we proposed to delete the mammography G-codes beginning for CY 2015 and to pay all mammography using the CPT

codes. We indicated that, although we believed that the CPT codes should now be used to report all mammography services, we had concerns about whether the current values for the CPT codes accurately reflect the resource inputs associated with furnishing the services. Because the CPT codes have not been recently re viewed and significant technologi cal changes have occurred since the current values were established, we did not believe it would be appropriate to retain the current values for the CPT codes. Therefore, we proposed to value the CPT codes using the RVUs previously established for the G-codes. We believed these values would be most appropriate since they were esta blished to reflect the use of digital technology, which is now typical.

As discussed in section II.B of this fina l rule with comment period, we proposed these CPT codes as potentially misvalued and reque sted that the RUC a nd other interested

stakeholders review these services in terms of appropriate work RVUs, work time assumptions, and direct PE inputs. However, as discussed in section II.B. of this fi nal rule with comment period, we will continue to maintain separate payment rates for film and digital mammography while we consider revaluation of all mammogr aphy services. For CY 2015, we will therefore maintain both the G-codes and CPT codes; we w ill continue using the 2014 RVUs from each of the following codes to price them for 2015: G0202, G0204, G0206, 77055, 77056, and 77057.CMS-1612-FC 63

2015. We also note that we will continue to pay for film mammography services at the 2014

rates until we revalue the mammography services.

We refer readers to section II.B. of this fi nal rule with comment period, where we address comments received on this proposal.

e. Radiation Treatment Vault In previous rulemaking (77 FR 68922, 78 FR 74 346), we indicated that we included the radiation treatment vault as a direct PE input fo r several recently review ed radiation treatment codes for the sake of consistency with its previous incl usion as a direct PE input for some other radiation treatment services, but that we intende d to review the radiati on treatment vault input

and address whether or not it should be included in the direct PE i nput database for all services in future rulemaking. Specifically, we questioned wh ether it was consistent with the principles underlying the PE methodology to include the radiation treatment vault as a direct cost given that it appears to be more similar to building infrastructure costs than to medical equipment costs. In response to this discussion, we received comments and invoices from stak eholders who indicated

that the vault should be classifi ed as a direct cost. However, upon review of the information received, we believed that the specific struct ural components require d to house the linear accelerator are similar in concep t to components required to hous e other medical equipment such as expensive imaging equipment. In genera l, the electrical, plum bing, and other building specifications are often unique to the intended functionality of a given building, including costs that are attributable to the sp ecific medical equipment housed in the building, but those building characteristics do not represent direct medi cal equipment costs in our established PE methodology. Therefore, we believed that the sp ecial building requirements indicated for the

radiation treatment vault to house a linear accelerator do not represent a dir ect cost in our PE methodology, and that the vault construction is instead accounted for in the indirect PECMS-1612-FC 64

methodology, just as the building an d infrastructure costs are treated for other PFS services including those with specialized infrastructure costs to accommodate specific equipment. Therefore, we proposed to remove the radiation treatment vault as a direct PE input from the radiation treatment procedures listed in Table 9, because we believed that the vault is not, itself, medical equipment; and therefore, it is acc ounted for in the indirect PE methodology.

TABLE 9: HCPCS Codes Affect ed by Proposed Removal of Radiation Treatment Vault HCPCS Short Descriptor 77373 Sbrt delivery 77402 Radiation treatment delivery 77403 Radiation treatment delivery 77404 Radiation treatment delivery 77406 Radiation treatment delivery 77407 Radiation treatment delivery 77408 Radiation treatment delivery 77409 Radiation treatment delivery 77411 Radiation treatment delivery 77412 Radiation treatment delivery 77413 Radiation treatment delivery 77414 Radiation treatment delivery 77416 Radiation treatment delivery 77418 Radiation tx delivery imrt

Comment: We received many comments regardi ng our proposal to remove the radiation

treatment vault as a direct cost from the ra diation treatment deliver y codes. Although one commenter supported the proposal , most commenters opposed the proposal. In general,

commenters reiterated their rationa le for inclusion of the vault as a direct practice expense input, asserting that the vault is necessary for the f unctioning of the equipment, serves a unique medical need, cannot be separated from the trea tment delivered by the linear accelerator, and cannot be repurposed for another us e. Commenters also stated th at the Internal Revenue Code treats the vault as medical equipment that is sepa rately depreciable from the building itself. For the most part, commenters objected to the remova l of the vault given th e context of decliningCMS-1612-FC 65

Medicare payment for radiation onc ology services over the past few y ears, or in conjunction with

the revised radiation treatment code set. Specifically, several comme nters suggested that stakeholders cannot provide meaningful comment about the impact of the vault proposal in the context of other pending changes. Some comment ers requested a phase-in of any decrease in payment so that providers of ra diation therapy services have an opportunity to adjust their practice costs. Several commenters also suggest ed that the change in payment could exacerbate problems in access to oncology services for Medicare patients. Response: We appreciate commenters’ concer ns regarding the proposal to remove the vault as a direct practice expense input. We unde rstand the essential nature of the vault in the provision of radiation therapy services and its uniqueness to a particular piece of medical equipment but are not convinced that either of these factors leads to the conclusion that the vault should be considered medical equipment for purposes of the PE methodology under the PFS. We appreciate the information commenters provided regarding th e IRS treatment of the vault under tax laws, but the purposes and goals of the tax code and the PFS PE methodology are different, and, as such, attempts to draw parallel s between the two are not necessarily instructive

or relevant. We are not finalizi ng our proposal at this time, but intend to further study the issues raised by the vault and how it relates to our PE methodology. Comment: A commenter noted that removing the vault as a direct cost also reduces the amount of indirect PE allocated for these proce dures, and that this proposal does not shift the vault from direct PE to indirect PE, but rather drops the cost of the vault entirely. Another commenter stated that since the pool of indirect PE RVUs associated with radiation oncology services is fixed, the issue in question is how the indirect cost s involved in furnishing treatment services compare to the indirect costs in providing other radiation oncology services.CMS-1612-FC 66

Response: We understand the concerns of commenters regarding the importance of ensuring that the costs related to the vault are included in the PE methodology. We want to point out, however, that within the established PE methodology, the allocation of indirect PE to individual codes has significan t impact on the PE RVUs that determine Medicare payment for

individual services. In other wo rds, we believe it is important for stakeholders to recognize that practice expense costs not included in the direct PE input database contribute to the development of PE RVUs through the data used to allocate indirect PE RVUs. We also want to point out that the pool of indirect PE RVUs is not fixed at the specialty level. Rather, the pool of indirect costs under the entire PFS is maintained from year to year, as delineated in step 11 of the PE methodology above. Therefore, changes in the a llocation of indirect PE for particular PFS services based on changes in either direct PE in puts, work RVUs, work time, or utilization data, impacts the amount of indirect PE allocated to a ll other PFS services , not just those furnished by specialties that furnish that service.

After continued review of the issues pertaining to the vault in the context of the comments, we believe that these issues require fu rther study. Therefore, at this time, we will

continue to include the vault as a direct PE input for the services listed in Table 9. f. Clinical Labor Input Errors Subsequent to the publicati on of the CY 2014 PFS final rule with comment period, it came to our attention that, due to a clerical error, the clinical labor type for CPT code 77293 (Respiratory Motion Management Simulation (list separately in addition to code for primary procedure)) was entered as L052A (Audiologist) instead of L152A (Medical Physicist), which has a higher cost per minute. We proposed a correcti on to the clinical labor t ype for this service. Comment: Commenters appreciated our proposal to corr ect this error.CMS-1612-FC 67

Response: We appreciate commenters’ support for our proposal, a nd are finalizing the assignment of clinical labor type L152A to code 77293 as proposed. The CY 2015 Direct Practice Expense Input database reflects this correction. In conducting a routine data review of the database, we also discovered that, due to a clerical error, the RN time allocated to CPT codes 33620 (Apply r&l pulm art bands), 33621 (Transthor cath for stent), and 33622 (Redo compl cardiac anomaly) was entered in the nonfacility setting, rather than in the facility setting where the code is valued. When a service is not valued in a particular setting, any inputs in cluded in that setting are not included in the

calculation of the PE RVUs for that service. Therefore, we proposed to move the RN time allocated to these procedures to the facility setting. The PE RVUs listed in Addendum B reflect

these technical corrections. We did not receive any comments on this proposal; therefore, we are finalizing our proposal to move the RN time allocated to these procedures to the facility setting. The CY 2015 Direct Practice Expense Input data base reflects this correction. g. Work Time Subsequent to the publicati on of the CY PFS 2014 final rule with comment period,

several inconsistencies in the work time file came to our attention. First, for some services, the total work time, which is used in our PE methodology, did not e qual the sum of the component parts (pre-service, intra-service, post-service, a nd times associated with global period visits).

The times in the CY 2015 work time file reflect ou r corrected values for total work time. Second, for a subset of services, the values in the pre-positioning time, pre-ev aluation time, and prescrub-dress-wait time, were inadve rtently transposed. We note th at this error had no impact on calculation of the total times, but has been corr ected in the CY 2015 work time file. Third, minor discrepancies for a series of interim final code s were identified between the work time file andCMS-1612-FC 68

the way we addressed these codes in the preamble text. Therefore, we have made adjustments to

the work time file to reflect the decisions indicat ed in the preamble text. The work time file is available on the CMS website under the supporti ng data files for the CY 2015 PFS final rule with comment period at http://www.cms.gov/PhysicianFeeSched/ . Note that for comparison purposes, the CY 2014 work tim e file is located at http://www.cms.gov/Medicare/Medicare-Feefor-Service-Payment/PhysicianFeeSched/PFS- Federal-Regulation-No tices-Items/CMS-1600-

FC.html

. Comment: A commenter supported our proposal to correct the work times associated with the procedures a ffected by this proposal. Response: We appreciate the commenter’s support for our proposal. After consideration of the comment received, we are finalizing our proposal to adjust the work time file as proposed.

The work time file is availa ble on the CMS website under the s upporting data files for the CY 2015 PFS final rule with comment period at http://www.cms.gov/PhysicianFeeSched/ h. Updates to Price for Existing Direct Inputs.

In the CY 2011 PFS final rule with comme nt period (75 FR 73205), we finalized a process to act on public requests to update equipm ent and supply price and equipment useful life inputs through annual rulemaking beginning w ith the CY 2012 PFS proposed rule. During 2013, we received a request to update the price of SD216 (catheter, balloon, esophageal or rectal (graded distention test)) from $217 to $237.50. We also received a request to update the price of SL196 (kit, HER-2/neu DNA Probe) from $105 to $144.50. We received invoices that documented updated pricing for each of these suppl y items. We proposed to increase the price associated with these supply items. We continue to believe it is important to ma intain a periodic and transparent process to update the price of items to reflect typical ma rket prices in our ratesetting methodology, and weCMS-1612-FC 69

continue to study the best way to improve our curre nt process. We remind stakeholders that we have difficulty obtaining accurate pricing information. The goal of the current transparent process is to offer the opportunity for the comm unity to both request supply price updates by providing us copies of paid invoices, and to object to proposed change s in price inputs for particular items by providing additional informati on about prices available to the practitioner community. We remind stakeholders that PFS payment rates are deve loped within a budget neutral, relative value system, and any increases in price inputs for particular supply items result in corresponding decreases to the relative va lues of all other di rect PE inputs.

We also received a RUC recommendation to u pdate the prices associ ated with two supply items. Specifically, the RUC recommended that we increase the price of SA042 (pack, cleaning and disinfecting, endoscope) from $15.52 to $17.06 to reflect the addition of supply item SJ009 (basin, irrigation) to the pack, and increase the price of SA019 (k it, IV starter) from $1.37 to $1.60 to reflect the addition of supply item SA044 ( underpad 2 ft. x 3 ft. (Chux)) to the kit. We proposed to update the prices for both of th ese items based on these recommendations. Comment: We received several comments regarding our concern about obtaining accurate pricing information for equipment and suppl y items included in the direct PE database.

The RUC indicated that it would continue to work with specialty societies to obtain paid invoices. A commenter suggested that a sample of paid invoices be obtained from practices and submitted with the PE materials to the RUC, or directly to CMS. Another commenter expressed concern regarding CMS’s assertion that invoices are difficult to obtai n, given that the RUC process collects lists of resources required to furnish serv ices in the physician office using a standardized process that is t ypically accompanied by invoices. Another commenter stated that CMS used only the lowest-cost invoice for a part icular equipment item since the other invoicesCMS-1612-FC 70

included “soft costs,” and that CM S should establish an approach th at would allow invoices to be used even if they contain “soft costs.” Response: We appreciate th e RUC’s assistance in obtaini ng paid invoices from the specialty societies. These invoi ces are helpful in pricing inputs . We disagree that we use the

lowest-cost invoice because it had the lowest cos t; rather, we often use the lowest-cost invoice

because we do not have a method to use invoices that include costs that are not included as part of the equipment costs, so called “soft costs,” within the PE methodology. We do not believe it would serve accuracy or relativity to include as part of the pric ing inputs “soft costs” that increase the price of particular supply or equipment items. We would welcome further input on potential approaches for “backing out” these costs. Comment: One commenter disagreed w ith CMS’s position that the RUC PE

Subcommittee’s review results in biased or inaccu rate resource input costs because the prices are largely maintained in the direct PE input database by CMS. Response: Although we did not raise this point in the CY 2015 PFS proposed rule, we refer readers to our discussion in previous rule making (for example, the CY 2011 PFS final rule with comment period at 75 FR 73250 and the CY 2014 PFS final rule with comment period at 78 FR 74246) regarding issues associated with obtai ning appropriate prices for medical equipment and supply items included in the direct PE database. We note that the RUC provides recommendations regarding the use of particular items in furnishing a service, but does not provide CMS with recommendations regarding the pr ices of direct PE item. Without assigning a price, the input cannot be fact ored in to our PE RVU method ology. Our price information is almost exclusively anecdotal, and generall y updated only through voluntary submission of a small number of invoices from the same practitione rs that furnish and are paid for the servicesCMS-1612-FC 71

that use the particular inputs. Therefore, we cont inue to believe there is potential for bias in the

information we receive. Comment: In its comment, the RUC suggest ed that an annual CM S review of paid invoices for high-cost supplies would be appropr iate. A commenter referenced comments made on the CY 2014 PFS final rule with comment pe riod, and expressed agreement with those commenters that the provision of pricing inform ation is sensitive because of issues involving proprietary pricing informati on and price negotiations for in dividual practitioners. This commenter also agreed with CMS that such info rmation would be less sens itive if it confirmed inputs contained in the direct PE database. However, the comm enter noted that requiring paid invoices from this point forwar d only partially addresses the c oncern since many existing inputs are not based on paid invoices; sp ecifically, societie s working on inputs for new, revised, or potentially misvalued services are disadvantaged in comparison to many existing inputs due to fee schedule relativity. The commenter sugge sted that CMS may need to undertake a comprehensive review of all direct PE inputs an d obtain paid invoices to systematically address

its concerns. Response: We share commenters’ concerns th at codes that are being reviewed may be disadvantaged relative to codes th at contain input prices that may not be based on paid invoices; and note that we rely on the public process to en sure continued relativity within the direct PE inputs. We encourage interested stakeholders to review updates to prices, as well as prices for new items, to ensure that they appear reasonabl e and current, and to pr ovide us with updated pricing information, particularly regarding high cost supplies that have a greater impact on relativity. We refer readers to se ction II.F. of this final rule with comment period, in which we detail price updates, as well as establish new prices, for inputs included in new, revised, and potentially misvalued codes.CMS-1612-FC 72

Comment: We received some comments in s upport of our proposal to update the price for SL196 (kit, HER-2/neu DNA Probe). Response: We appreciate the commenters’ s upport for our proposal to update the price for SL196. After publication of our proposal, we obtained new information suggesting that further study of the price of this item is necessa ry before proceeding to update the input price. Therefore, we are not finalizi ng our proposal to update the pri ce for SL196, and will consider this matter in future rulemaking.

Comment: We did not receive any comments regarding our proposal to update the price for of SD216 (catheter, ball oon, esophageal or rectal (g raded distention test)). Response: We are finalizi ng the price updates for SD216. Comment: We received comments in support of the price update to SA019 (kit, IV starter) and SA042 (pack, cleaning and disinfecting, endoscope). Response: We appreciate the commenters’ s upport for our proposal to update the price

for SA019 and SA042. After consid eration of comments received, we are finalizing the price updates for SA019 and SA042. i. New Standard Supply P ackage for Contrast Imaging The RUC recommended creating a new dire ct PE input standard supply package “Imaging w/contrast, standard package” for cont rast enhanced imaging, with a price of $6.82. This price reflects the combined prices of the medical supplies in cluded in the package; these items are listed in Table 10. We proposed to accept this recommenda tion, but sought comment

on whether all of the items included in th e package are used in the typical case. The CY 2015 direct PE database reflects this change and is available on the CMS website under the supporting data files for the CY 2015 PFS proposed rule at http://www.cms.gov/PhysicianFeeSched/

.CMS-1612-FC 73

TABLE 10: Standard Cont rast Imaging Supply Package Medical Supply Description CMS Supply

Code Unit Quantity Price

Kit, IV starter SA019 Kit 1 $1.60 Gloves, non-sterile SB022 Pair 1 0.084 Angiocatheter 14g-24g SC001 Item 1 1.505 Heparin lock SC012 Item 1 0.917 IV tubing (extension) SC019 Foot 3* 1.590 Needle, 18-27g SC029 Item 1 0.089 Syringe 20ml SC053 Item 1 0.558 Sodium chloride 0.9% inj. bacterio static (30ml uou) SH068 Item 1 0.700 Swab-pad, alcohol SJ053 Item 1 0.013 TOTAL $7.06 * The price for SC019 (IV tubing, (extension)) is $0.53 per foot.

Comment: Commenters supported our proposal to create the standard supply package for contrast imaging. Some commenters expressed concern that the proposed supply package did not include the full range of supplies typically used when performing contrast imaging. One commenter stated that, for echocardiography la bs that utilize contrast-enhanced ultrasound, additional items are typically part of the contrast imaging suppl y package, including 2x2 gauze pads, a stopcock, and tape. Another commenter s uggested that a power inj ector should also be included in the standard contrast imaging suppl y package. Commenters also noted that CMS provided limited information regarding how the prices were assigned to the supply items, and pointed to discrepancies between th e direct PE database files and th e prices quoted in the table. Response: We appreciate comm enters’ support for our propos al. We note that the RUC recommendation for the standard contrast imagi ng supply package also noted that the inputs for

CTA and MRA studies would include the standard contrast imaging supply pack in addition to a stop cock (SC050) and additional tubing. While we acknowledge a commenter’s suggestion that additional items may be used when echocardi ography labs conduct cont rast-enhanced ultrasound studies, we do not have informa tion to suggest that these item s are used for other imaging studies, such as CT and MRI c ontrast-enhanced studies. We would welcome more informationCMS-1612-FC 74

on whether these items should be included in the ne wly created standard cont rast imaging kit, as well as whether the power injector is used when ever the other inputs in the standard contrast imaging supply package are used, or whether they are used only in certain instances. We note that the reason for the discrepancy in the price for the IV starter ki t is that we proposed to update the price at the same time that we proposed to cr eate a new contrast imaging kit. Since we are finalizing the price update for SA019 (kit, IV starter), we are also finalizing a revised price for the new standard contrast imaging package of $7.06. Finally, we disagree with the commenter’s suggestion that CMS provided limited information about the pricing for the items included in the kit, as these items are existing inputs in the di rect PE database, and the codes associated with these items were listed in the table in the pr oposed rule. After consideration of comments received, we are finalizing our pr oposal to create a standard cont rast imaging supply pack, with a revised price of $7.06. j. Direct PE Inputs for Stereotactic Radios urgery (SRS) Services (CPT Codes 77372 and 77373)

In the CY 2014 PFS final rule with comme nt period (78 FR 74245), we summarized

comments received about whether CPT code s 77372 and 77373 would accurately reflect the resources used in furnishing the typical SRS deliv ery if there were no coding distinction between robotic and non-robotic delivery methods. Until now, SRS services furnished using robotic methods were billed using contractor-priced G-codes G0339 (Image-guided robotic linear accelerator based stereotactic radiosurgery, comple te course of therapy in one session or first session of fractionated treatment), and G0340 (Im age-guided robotic linear accelerator-based stereotactic radiosurgery, delivery including collimator changes and custom plugging, fractionated treatment, all lesions, per sessi on, second through fifth sessions, maximum five sessions per course of treatment). We indicated that we would consider deleting these codes in future rulemaking.CMS-1612-FC 75

Most commenters responded that the CPT c odes accurately described both services, and the RUC stated that the direct PE inputs for the CPT codes accurately accounted for the resource

costs of the described services. One commenter objected to the deletion of the G-codes but did not include any information to su ggest that the CPT code s did not describe the services or that the direct PE inputs for the CPT codes were in accurate. Based on a review of the comments received, we had no indication th at the direct PE inputs includ ed in the CPT codes would not reflect the typical resource inputs involved in furnishing an SRS service. Therefore, in the CY 2014 proposed rule we proposed to recognize only th e CPT codes for SRS services, and to delete the G-codes used to report robotic delivery of SRS. Comment: We received several comments rega rding our proposal to delete the SRS Gcodes. Some commenters supported our propos al, but most opposed our proposal on the grounds that the direct PE inputs include d in the CPT codes do not reflect the typical resource inputs used in furnishing robotic SRS services. Some co mmenters urged CMS to delay this policy change and continue to contractor price the G-codes until a more appropriate solution can be found. Response: After consideration of the comments rega rding the appropriate inputs to use in pricing the SRS services, we have concluded that at this time, we lack sufficient information to make a determination about the appropriatene ss of deleting the G-codes and paying for all SRS/SBRT services using the CPT codes. Theref ore, we will not delete the G-codes for 2015,

but will instead work with stakehol ders to identify an alternate approach and reconsider this issue in future rulemaking. k. Inclusion of Capnograph for Pedi atric Polysomnography Services We proposed to include equipment it em EQ358, Sleep capnograph, polysomnography (pediatric), for CPT codes 95782 (Polysomnography; younger than 6 years, sleep staging with 4 or more additional parameters of slee p, attended by a tec hnologist) and 95783CMS-1612-FC 76

(Polysomnography; younger than 6 years, sleep stag ing with 4 or more additional parameters of sleep, with initiation of continuous positive airw ay pressure therapy or bi-level ventilation, attended by a technologist). Based upon our understanding that capnography is a required element of sleep studies for patients younger than 6 years, we proposed to allocate this equipment item to 95782 for 602 minutes, and 95783 for 647 minutes. Based on the invoice we received for this equipment item, we proposed to price EQ358 at $4,534.23.

Comment: We received two comments in s upport of our proposal to include the capnograph in CPT codes 95782 and 95783.

Response: We appreciate comm enters’ support for our propos al. After cons ideration of comments received, we are finali zing our proposal to include the capnograph in CPT codes

95782 and 95783.

4. Using OPPS and ASC Rates in Developing PE RVUs Accurate and reliable pricing information fo r both individual items and indirect PEs is

critical to establish accurate PE RVUs for PFS services. As we have addressed in previous rulemaking, we have serious concerns regarding th e accuracy of some of the information we use in developing PE RVUs. In particular, as disc ussed in the CY 2014 PFS final rule with comment period, we have several longstandi ng concerns regarding the accu racy of direct PE inputs, including both items and proce dure time assumptions, and pri ces of individual supplies and equipment (78 FR 74248– 74250). In addition to th e concerns regarding the inputs used in valuing particular procedures, we also noted th at the allocation of i ndirect PE is based on information collected several years ago (as desc ribed above) and will likely need to be updated in the coming years. To mitigate the impact of some of these poten tially problematic data used in developing values for individual services, in rulemaki ng for the CY 2014 PFS, we proposed to limit theCMS-1612-FC 77

nonfacility PE RVUs for indivi dual codes so that the total nonfacility PFS payment amount would not exceed the total combined amount that Medicare would pay for the same code in the facility setting. In developing the proposal, we sought a reliable means for Medicare to set upper payment limits for office-based procedures and believed OPPS and ASC payment rates would provide an appropriate comparis on because these rates are based on relatively more reliable cost information in settings with cost structures that generally would be expected to be higher than in the office setting. We received many comments regarding our propos al, the vast majority of which urged us to withdraw the proposal. Some commenters questioned the validity of our assumption that facilities’ costs for providing al l services are necessarily high er than the costs of physician offices or other nonfacility setti ngs. Other commenters expresse d serious concerns with the asymmetrical comparisons between PFS paym ent amounts and OPPS/ASC payment amounts. Finally, many commenters suggested revisions to technical aspects of our proposed policy. In considering all the comments, however, we were persuaded that the comparison of OPPS (or ASC) payment amounts to PFS payment am ounts for particular procedures is not the most appropriate or effective approach to ensu ring that PFS payment rates are based on accurate cost assumptions. Commenters noted several flaws with the approach. First, unlike PFS payments, OPPS and ASC payments for individual se rvices are grouped into rates that reflect the costs of a range of services. Second, commenter s suggested that since the ASC rates reflect the OPPS relative weights to determine payment ra tes under the ASC payment system, and are not

based on cost information collected from ASCs , the ASC rates should not be used in the proposed policy. For these and ot her reasons raised by commenters , we did not propose a similar policy for the CY 2015 PFS. If we consider us ing OPPS or ASC payment rates in developingCMS-1612-FC 78

PFS PE RVUs in future rulemaking, we would cons ider all of the comments received regarding the technical application of the previous proposal. After thorough consideration of the comm ents regarding the CY 2014 proposal, we

continue to believe that there ar e various possibilities for levera ging the use of available hospital cost data in the PE RVU methodology to ensure that the relative costs for PFS services are developed using data that is auditable and comprehensively and regularly updated. Although some commenters questioned the premise that the hospital cost data are more accurate than the information used to establish PE RVUs, we c ontinue to believe that the routinely updated, auditable resource cost information submitted contemporaneously by a wide array of providers across the country is a valid refl ection of ‘‘relative’’ resources and could be useful to supplement the resource cost information developed unde r our current methodology based upon a typical case that are developed with information from a small number of representative practitioners for a small percentage of codes in any particular year. Section 220(a)(1) of the PA MA added a new subparagraph (M) under section 1848(c)(2) of the Act that gives us authority to collect in formation on resources used to furnish services from eligible professionals (including physicia ns, non-physician practitioners, PTs, OTs, SLPs and qualified audiologists), and othe r sources. It also authorizes us to pay eligible professionals for submitting solicited information. We will be exploring ways of collecting better and updated resource data from physician practices, includ ing those that are provi der-based, and other nonfacility entities paid through the PFS. We believe such efforts will be challenging given the wide variety of practices, and that a ny effort will likely impose some burden on eligible professionals paid through the PFS regardless of the scope a nd manner of data collec tion. Currently, through

one of the validation contracts di scussed in section II.B. of this final rule with comment period, we have been gathering time data directly fr om physician practices. Through this project, weCMS-1612-FC 79

have learned much about the challenges for both CMS and the eligible prof essionals of collecting data directly from practices. Our own experience has shown that is difficult to obtain invoices for supply and equipment items that we can use in pricing direct PE inputs. Many specialty societies also have noted the challenges in obtaining recent invoices for medical supplies and equipment (78 FR 74249). Further, PE calculations rely heavily on information from the Physician Practice Expense Information Survey (PPIS) survey, which, as discussed earlier, was conducted in 2007 and 2008. When we implemented the results of the survey, many in the community expressed serious c oncerns over the accuracy of this or other PE surveys as a way of gathering data on PE input s from the diversity of providers paid under the

PFS. In addition to data collection, section 1848( c)(2)(M) of the Act as added by section 220(a) of the PAMA provides author ity to develop and us e alternative approach es to establish PE relative values, including the use of data from ot her suppliers and providers of services. We are exploring the best approaches for exercising th is authority, including wi th respect to use of hospital outpatient cost data. We understand that many stakeholders will have concerns regarding the possibility of using hospital outpatient cost da ta in developing PE RVUs under the PFS, and we want to be sure we are aware of th ese prior to considering or developing any future proposal relying on those data. Therefore, in the CY 2015 PFS proposed rule (79 FR 40333), we sought comment on the possible uses of the Medicare hospital outpatient cost data (not the APC payment amount) in potential revisions of the PFS PE methodology. This could be as a means to validate or, perhaps, in setting the relative resource cost assumptions within th e PFS PE methodology. We noted that the resulting PFS payment amounts would not n ecessarily conform to OPPS payment amounts since OPPS payments are grouped into APCs, while PFS payments would continue to be valuedCMS-1612-FC 80

individually and would remain s ubject to the relativit y inherent in establishing PE RVUs, budget neutrality adjustments, and PFS updates. We expr essed particular intere st in comments that compare such possibilities to other broad-base d, auditable, mechanisms for data collection, including any we might consid er under the authority provide d under section 220(a) of the PAMA. We urged commenters to consider a wide range of options for gathering and using the data, including using the data to validate or se t resource assumptions for only a subset of PFS services, or as a base amount to be adju sted by code or spec ialty-level recommended adjustments, or other potential uses. We appreciate the many thoughtful comments that we

received on whether and how to use the OPPS cost data in establishing PE relative values. We will consider these as we continue to think about mechanisms to improve the accuracy of PE

values. In addition to soliciting comments as noted above, in the CY 2015 proposed rule we

stated that we continue to seek a better understanding regarding th e growing trend toward hospital acquisition of physicians’ o ffices and how the subsequent treatment of those locations as off-campus provider-based outpa tient departments affects paym ents under PFS and beneficiary cost-sharing. MedPAC continue s to question the appropriateness of increased Medicare payment and beneficiary cost-sharing when physicians’ o ffices become hospital outpatient departments, and to recommend that Medicare pay selected ho spital outpatient services at PFS rates (MedPAC

March 2012 and June 2013 Report to Congress ). We noted that we al so remain concerned about the validity of the resource data as more physic ian practices become provider-based. Our survey data reflects the PE costs for particular PFS speci alties, including a propor tion of practices that may have become provider-based since the survey was conducted. Additionally, as the proportion of provider-based offi ces varies among physician sp ecialties, so do the relative accuracy of the PE survey data. Our current PE methodology primarily distinguishes betweenCMS-1612-FC 81

the resources involved in furnishi ng services in two sites of serv ice: The non-facility setting and the facility setting. In principle, when services are furnished in the non-facility setting, the costs associated with furnishing services include all di rect and indirect PEs a ssociated with the work and the PE of the service. In contrast, when se rvices are furnished in the facility setting, some costs that would be PEs in the office setting are incurred by the facili ty. Medicare makes a separate payment to the facility to account for some portion of these costs, and we adjust PEs accordingly under the PFS. As more physician practices become hospital-based, it is difficult to know which PE costs typically are actually incu rred by the physician, which are incurred by the hospital, and whether our bifurcated site-of service differential adequately accounts for the typical resource costs given these relationships. We al so have discussed this issue as it relates to accurate valuation of visits within the postope rative period of 10- and 90-day global codes in

section II.B.4 of this fina l rule with comment period. To understand how this trend is affecting Me dicare, including the accuracy of payments made through the PFS, we need to develop data to assess the extent to wh ich this shift toward hospital-based physician practices is occurring. To that e nd, during CY 2014 rulemaking we sought comment regarding the best method for co llecting information that would allow us to analyze the frequency, type, and payment for se rvices furnished in off-campus provider-based hospital departments (78 FR 74427). We recei ved many thoughtful comments. However, the commenters did not present a consen sus opinion regarding the options we presented in last year’s rule. Based on our analysis of the comments, we stated that we believed the most efficient and equitable means of gathering this important in formation across two different payment systems

would be to create a HCPCS modi fier to be reported with ever y code for physicians’ and hospital services furnished in an off-campus pr ovider-based department of a hospital.CMS-1612-FC 82

We proposed that the modifier would be reported on both the CMS–1500 claim form for physicians’ services and the UB–04 (CMS form 1450) for hospital outpatient claims. (We note that the requirements for a determination that a facility or an organi zation has provider-based status are specified in §413.65, and we define a hospital campus to be the physical area immediately adjacent to the provider’s main build ings, other areas and st ructures that are not strictly contiguous to the main buildings but ar e located within 250 yards of the main buildings, and any other areas determined on an individual case basis, by the CMS regional office.) Therefore, we proposed to coll ect this information on the type and frequency of services furnished in off-campus provide r-based departments in accord ance with our authority under section 1848(c)(2)(M) of the Act (as added by section 220(a) of the PAMA) beginning January 1, 2015. The collection of this information would a llow us to begin to assess the accuracy of the PE data, including both the service-level direct PE inputs and the specialty-level indirect PE information that we currently use to value PFS serv ices. Furthermore, this information would be critical in order to develop proposed improveme nts to our PE data or methodology that would appropriately account for the different resource co sts among traditional office, facility, and offcampus provider-based settings. We also sough t additional comment on whether a code modifier is the best mechanism for collecting this service-level information.

Comment: Many commenters agreed on the need to collect information on the frequency, type, and payment of services furnished in o ff-campus provider-based departments of hospitals, however, several commenters expressed concern that the HCPCS modifier would create

additional administrative burden fo r providers. Many of these comm enters stated that the new modifier would require significan t changes to hospitals’ billing systems, including a separate charge master for outpatient off-campus PBDs and training for staff on how to use the new modifier. Several commenters thought that ed ucation and training wo uld be required forCMS-1612-FC 83

physician offices to attach a modifier to servi ces furnished in an off-campus provider-based department. These same commenters suggested th at a new place of service (POS) code would be more appropriate for physician billing. Several commenters suggested that CMS should repropose a detailed data collection methodology, test it with providers, make adjustments, and allow additional time for implementation. Response: While we understand comment ers’ concerns about the additional administrative burden of reporting a new HCPCS modifier, we have weighed the burden of reporting the modifier for each service against the benefit of having data that will allow us to

obtain and assess accurate inform ation on the type and frequency of outpatient hospital services furnished in off-campus provider- based departments, and we do not believe that the modifier is excessively burdensome for providers to report. When billing for hospital services, providers

must know where services are furnished in order to accurately complete value code 78 of an outpatient claim or item 32 for service location on the practitioner claim. However, as discussed later in this section, we agree th at a POS code on the professional claim allows for the same type

of data collection as a modifier and would be less burdensome than the modifier for practitioners. We discuss the timeframe for implem entation later in this section.

Comment: Some commenters w ho were concerned about the administrative burden of the new HCPCS modifier suggested several alte rnative methods for CMS to collect data on services furnished in off-campus provider-based departments. Several of these commenters recommended that CMS consider establishing of a new POS code for professional claims, or for both professional and hospital claims, because th ey believed this approach would be less administratively burdensome than attaching a modifi er to each service re ported on the claim that was furnished in an off-campus provider-based department. Some commenters preferred identifying services furnished in provider-based departments on the Medicare cost report (CMS-CMS-1612-FC 84

2552-10). Some commenters suggested using pr ovider numbers and addresses to identify offcampus PBDs, or changing the provider enrollment pr ocess to be able to track this data. Yet other commenters suggested creating a new bill t ype to track off-campus PBD services. Commenters generally recommended that CMS choose the least administratively burdensome approach that would ensure accurate data collection, but did not necessarily agree on what approach would optimally achieve that result. Some commenters believed that a

HCPCS modifier would more clea rly identify specific services furnished at off-campus PBDs, and would provide better information about th e type and level of care furnished. Some

commenters believed that a HCPCS modifier would be the least administratively burdensome approach because hospitals and physicians already report a number of clai ms-based modifiers. However, other commenters stated that addi tional modifiers would increase administrative burden because this approach would increase the modifiers that would need to be considered when billing. Response: With respect to creating a new PO S code to obtain data on services furnished in off-campus PBDs of a hospital, we note th at POS codes are only reported on professional

claims and are not included on in stitutional claims. Therefore, a POS code could not be easily implemented for hospital claims. However, POS codes are already required to be reported on every professional claim, and POS 22 is currently used when physicians’ services are furnished in an outpatient hospital depart ment. (More information on exis ting POS codes is available on the CMS Website at http://www.cms. gov/Medicare/Coding/place-of-servicecodes/Place_of_Service_Code_Set.html). Though we considered proposing a new POS code for professional claims to collect data on services furnished in the off-campus hospita l setting, we note that previous GAO and OIG reports (October 2004 A-05-04-0025, January 2005 A-06-04-00046, July 2010 A-01-09-00503 ,CMS-1612-FC 85

September 2011 A-01-10-00516 ) have noted frequent inaccuracies in the reporting of POS codes. Additionally, at the time the proposed rule was developed, we had concerns that using a POS code to report this information might not give us the reliable data we are looking to collect, especially if such data were to be cross-walked with hospital claims for the same service, since the hospital claim would have a mo difier, not a POS code. Howeve r, we have been persuaded by public comments suggesting that use of a POS code on professional claims would be less administratively burdensome than use of a modifier, and would be more familiar to those involved in practitioner billing. Specifically, since a POS code is already required on every professional claim, we believe that creating a new POS code to distinguish outpatient hospital services that are furnished on the hospital cam pus versus in an off-campus provider-based department would require less st aff training and education than would the use of a modifier on the professional claim. Additi onally, professional claims only ha ve space for four modifiers; while a very small percentage of professional cl aims have four modifier s, required use of an additional modifier for every pr ofessional claim could lead to more occurrences where there would not be space for all applicable payment modifiers for a specific service. Unlike institutional claims, we note th at a new professional claim is required whenever the place of service changes. That is, even if the same prac titioner treats the same patient on the same day in the office and the hospital, the services furnished in the office setting must be submitted on one claim with POS 11 (Office), while those furnishe d in the outpatient hospital department would be submitted on a separate claim with POS 22 (O utpatient Hospital). Likewise, if a new POS code were to be created for off-campus outpatien t provider-based hospital department, a separate claim for services furnished in that setting w ould be required relative to a claim for outpatient services furnished on the hospital’s main campus by the same practitioner to the same patient on the same day. Based on public comments and afte r further consultation with Medicare billingCMS-1612-FC 86

experts, we believe that use of the POS code on professional claims would be no less accurate than use of a modifier on professional claims in identifying services furnished in off-campus PBDs. In addition, we believe that the POS code would be less administratively burdensome for practitioners billing using the pr ofessional claim since a POS code is already required for every professional claim. With respect to adding new fields to existi ng claim forms or creating a new bill type, we

do not believe that this data co llection warrants these measures. We believe that those changes would create greater administra tive burden than the proposed HC PCS modifier and POS codes, especially since providers are already accustomed to using modifiers and POS codes. Revisions

to the claim form to add new fields or an additional bill type woul d create significant

administrative burden to revise claims processing systems and educate providers that is not necessary given the availability of a modifier and POS codes. Though providers may not be

familiar with this new modifier or any new POS code; since thes e types of codes already exist generally for hospital and profe ssional claims, providers and s uppliers should already have an understanding of these types of codes and how to apply them. Finally, we do not believe that expansions to the claim form or use of a new bill type would provide us with detailed information on exactly which services were fu rnished in an off-campus PBD versus those furnished on the main campus when those services are furnished on the same day. We also do not believe that we could accurately determine which services are furnished at off-campus provider-base departments (PBDs) using currently availa ble NPI and facility address data. Hospitals are requi red to report the nine-digit ZIP code indicating where a service was furnished for purposes of paying properly for physician and anesthesia services paid off the

PFS when that ZIP code differs fr om the master address for the hos pital on file in CMS claims systems in value code 78 (pub 100-04, transmittal 1681, February 13, 2009). However, theCMS-1612-FC 87

billing ZIP code for the hospital main campus co uld be broad enough to incorporate on and offcampus provider-based departments. Further, a ZIP code reported in value code 78 does not allow CMS to distinguish between services furnis hed in different locations on the same date. Therefore, we do not believe that a comparison of the ZIP code captured in value code 78 and the main campus ZIP code is sufficiently precise. Finally, while we considered the suggesti on that CMS use currently reported Medicare hospital cost report (CMS-2552-10) da ta to identify services furn ished at off-campus PBDs, we note that though aggregate data on services furn ished in different settings must be reported through the appropriate cost center, we would not be able to obtai n the service-specific level of

detail that we would be able to obtain from claims data. We will take under consideration the suggesti on that CMS create a way for hospitals to report their acquisition of physicia n offices as off-campus PBDs through the enrollment process, although this information, as currently reported, would not allow us to know exactly which services are furnished in off-campus provide r based departments and which services are furnished on the hospital’s main campus when a hospital provides both on the same day. Comment: Commenters noted that the propos ed modifier would not allow CMS to know the precise location of the off-campus provider-b ased department for billed services or when services are furnished at different off-campus provider-based locations in the same day. Response: We agree that ne ither the proposed modifier nor a POS code provides details on the specific provider-based location for each furnished service. However, we believe that collecting information on the t ype and frequency of services furnished at all off-campus

locations will assist CMS in bett er understanding the distribution of services be tween on and offcampus locations.CMS-1612-FC 88

Comment: MedPAC believed there may be so me value in collecti ng data on services furnished in off-campus provide r-based departments to validate the accuracy of site-of-service reporting when the physician’s office is off-campus but bills as an outpatient department. MedPAC indicated that any data collection effort should not prev ent the development of policies to align payment rates across settings. MedPAC en couraged CMS to seek legislative authority to set equal payment rates across settings for eval uation and management office visits and other

select services. Response: We thank MedPAC for its support of our data collection e fforts to learn more about the frequency and types of services that are being furnished in off-campus PBDs.

Comment: Many commenters suggested that provider s would not be able to accurately apply the new modifier by the January 1, 2015 implementation timeline and recommended a one-year delay before providers would be required to apply the modifier to services furnished at off-campus PBDs. Some commenters request ed only a six-month delay in implementation. Commenters indicated that significant revisions to internal billing processes would require additional time to implement. Response: Though we belie ve that the January 1 st effective date that applies to most policies adopted in the final rules with comme nt period for both the PFS and the OPPS would provide sufficient lead time, we understand comment ers’ concerns with the proposed timeline for implementation given that the new reporting re quirements may require changes to billing systems as well as education and training for staff. With respect to the POS code for professional claims, we will request two new POS codes to replace POS code 22 (Hospital Outpatient) through the POS Workgroup and expect that it will take some time for these new

codes to be established. Once th e revised POS codes are ready a nd integrated into CMS claims systems, practitioners would be required to use them, as applicable. More information on theCMS-1612-FC 89

availability of the new POS codes will be forthc oming in subregulatory guidance, but we do not expect the new codes to be available prior to July 1, 2015. There will be no voluntary reporting period of the POS codes for applicable professi onal claims because each professional claim requires a POS code in order to be accepted by Me dicare. However, we do not view this to be problematic because we intend to give prior notice on the POS coding changes and, as many public commenters noted, because practitioners ar e already accustomed to using a POS on every claim they submit. We also are finalizing our proposal to crea te a HCPCs modifier for hospital services furnished in an off-campus PBD setting; but we are adopting a voluntary reporting period for the new HCPCS modifier for one year. That is, reporting the new HCPCS mo difier for services furnished at an off-campus PBD will not be ma ndatory until January 1, 2016, in order to allow providers time to make systems changes, test th ese changes, and train staff on use of the new modifier before reporting is requ ired. We welcome early reporti ng of the modifier and believe a full year of preparation should pr ovide hospitals with sufficient tim e to modify their systems for accurate reporting.

Comment: Many commenters expressed concern th at this data collection would eventually lead to equalizing payment for simila r services furnished in the non-facility setting and the off-campus PBD setting. Several commente rs noted that the trend of hospitals acquiring physician practices is due to efforts to better integrate care delivery, a nd suggested that CMS weigh the benefits of care integration when deciding payment changes. Some commenters suggested that CMS should use th e data to equalize payment for similar services between these two settings. These commenters suggest that ther e is little difference in costs and care between the two settings that would warrant the differen ce in payment. Several of these commenters highlighted beneficiary cost shari ng as one reason for site-neutral payment, noting that the totalCMS-1612-FC 90

payment amount for hospital outpatient services is generally higher than the total payment amount for those same services when furnished in a physician’s office. Response: We appreciate the co mments received. At this ti me, we are only finalizing a

data collection in this final rule with comment period. We did not propose, and therefore, are not finalizing any adjustment to payments fu rnished in the off-campus PBD setting.

Comment: Several commenters noted th at the CMS proposal would not provide additional information on how a physician practice billed prior to becoming an off-campus PBD, which would be important for anal yzing the impact of this trend. Response: We agree that, in analyzing the impact of this tre nd, it is important to understand physician billing patterns that were in place prior to becoming an off-campus PBD,

and we will continue to evaluate ways to analyze claims data to gather this information. We believe that collecting data using the additional modifier and POS c ode as finalized in this rule will be an important tool in furthering this analysis.

Comment: Some commenters s uggested that the term “off- campus” needs to be better defined. Commenters asked how billing would occu r for hospitals with multiple campuses since the CMS definition of campus references main bu ildings and does not include remote locations.

One commenter also asked whether the modifier is intended to cover services furnished in freestanding emergency departments. Response: For purposes of the modifier and th e POS codes we are finalizing in this final rule with comment period, we define a “campus ” using the definition at §413.65(a)(2) to be the physical area immediately adjacent to the provider’s main buildings, other areas and structures that are not strictly contiguous to the main build ings but are located within 250 yards of the main buildings, and any other areas determined on an individual case basis, by the CMS regional office, to be part of the provider’s campus. We agree with commenters that our intent is toCMS-1612-FC 91

capture data on outpatient services furnished off of the hospital’s main campus and off of any of the hospital’s other campuses. The term “remot e location of a hospital” is defined in our regulations at section 413.65(a)(2 ). Under the regulation, a “rem ote location” includes a hospital campus other than the main hospital campus. Specifi cally, a remote location is “a facility or an organization that is either crea ted by, or acquired by, a hospital that is a main provider for the purposes of furnishing inpatient hospital services under the name , ownership, and financial and administrative control of the main provider....” Therefore, we agree with the commenters that

the new HCPCS modifier and the POS code for off-campus PBDs should not be reported for

services furnished in remote locat ions of a hospital. The term “remote location” does not include “satellite” locations of a hospital. However, since a satellite facil ity is one that provides inpatient services in a building also used by another hospital, or in one or more entire buildings located on the same campus as buildings used by another hospital, the new HCPCS modifier and the POS code for off-campus hospital PBDs should not be reported for services furnished in satellite

facilities. Satellite f acilities are described in our re gulations at §412.22(h). Accordingly, reporting of the modifier and the POS code that identifies an off-campus hospital PBD would be required for outpatient services furnished in PBDs that are located beyond 250 yards from the main campus of the hospital, excl uding services furnished in a remo te location or satellite facility of the hospital. We also appreciate the comment on emerge ncy departments. We do not intend for hospitals to report the new modifi er for services furnished in em ergency departments. We note that there is already a POS code for the em ergency department, POS 23 (emergency roomhospital), and this would continue to be used on professional claims for services furnished in emergency departments. That is, the new POS c ode for off-campus hospital PBDs that will be created for purposes of this data collection woul d not apply to emergency department services.CMS-1612-FC 92

Hospitals and practitioners that have questions about which depa rtments are considered to be “off-campus PBDs” should review additional gui dance that CMS releases on this policy and work with the appropriate CMS regional offi ce if individual, specific questions remain.

Comment: Several commenters asked for clarif ication on when to report the modifier for services furnished both on and off-campus on th e same day. Commenters provided several scenarios of visits and diagnostic se rvices furnished on the same day. Response: The location where the service is actually furnished would dictate the use of the modifier and the POS codes, regardless of where the order for services is initiated. We expect the modifier and the POS code for off-campus PBDs to be reported in locations in which the hospital expends resources to furnish th e service in an off-campus PBD setting. For example, hospitals would not report the modifier for a diagnostic test that is ordered by a practitioner who is located in an off-campus PBD when the service is actually furnished on the main campus of the hospital. This issue does not impact use of the POS codes since practitioners submit a different claim for each POS where they furnish services for a specific beneficiary.

Comment: A few commenters asked for clarifi cation on whether their entity constitutes a provider-based department. Response: Provider-based departments are de partments of the hospital that meet the criteria in §413.65.

Comment: A commenter recommended that CMS publish the data it acquires through adoption of this modifier. Response: Data collected through the new HCPCS modifier would be part of the

Medicare Limited Data Set and would be availabl e to the public for purch ase along with the rest of the Limited Data Set. Similarly, professiona l claims data with revised POS coding would be available as a standard analytic file for purchase.CMS-1612-FC 93

In summary, after considerati on of the comments received, we are finalizing our proposal with modifications. For professional claims, inst ead of finalizing a HCPCS modifier, in response to comments, we will be deleting current POS code 22 (outpatient hospital department) and establishing two new POS codes— one to identif y outpatient services furnished in on-campus,

remote or satellite locations of a hospital, and another to identify services furnished in an offcampus hospital PBD setting that is not a remote lo cation of a hospital, a satellite location of a hospital or a hospital emergency department. We will maintain the separate POS code 23 (emergency room-hospital) to identify services furnished in an emergency department of the hospital. These new POS codes will be required to be reported as soon as they become available, however advance notice of the availability of th ese codes will be shared publicly as soon as practicable. For hospital claims, we are creating a HCPCS modi fier that is to be reported with every code for outpatient hospital servi ces furnished in an off-campus PBD of a hospital. This code will not be required to be reported for remote lo cations of a hospital defined at §412.65, satellite facilities of a hospital define d at §412.22(h) or for services furnished in an emergency department. This 2-digit modifier will be adde d to the HCPCS annual file as of January 1, 2015, with the label “PO,” the short descriptor “Ser v/proc off-campus pbd,” an d the long descriptor “Services, procedures and/or surgeries furn ished at off-campus provider-based outpatient departments.” Reporting of this new modifier will be voluntary for 1 year (CY 2015), with reporting required beginning on January 1, 2016. A dditional instruction a nd provider education will be forthcoming in subregulatory guidance.CMS-1612-FC 94

B. Potentially Misvalued Services Under the Physician Fee Schedule 1. Valuing Services Under the PFS Section 1848(c) of the Act requires the S ecretary to determine relative values for physicians' services based on three components: work, PE, and malpractice. Section 1848(c)(1)(A) of the Act defines the work component to mean, “the portion of the resources used in furnishing the service that reflects physician ti me and intensity in furn ishing the service.” In addition, section 1848(c)(2)(C)(i) of the Act spec ifies that “the Secret ary shall determine a number of work relative value units (RVUs) fo r the service based on the relative resources incorporating physician time and intensity required in furnishing the service.” Section 1848(c)(1)(B) of the Act defines th e PE component as “the portion of the resources used in furnishing the service that refl ects the general categories of expenses (such as office rent and wages of personnel, but exclud ing malpractice expens es) comprising practice expenses.” Section 1848(c)(2)(C )(ii) of the Act requires that PE RVUs be determined based upon the relative PE resources involved in furnishing the service. (See section II.A. of this final rule with comment period for more detail on the PE component.) Section 1848(c)(1)(C) of the Act defines th e MP component as “the portion of the resources used in furnishing the service that re flects malpractice expenses in furnishing the service.” Section 1848(c)(2)(C)(i ii) of the Act specifies that MP expense RVUs shall be determined based on the relative MP expense resour ces involved in furnishing the service. (See

section II.C. of this final rule with comment period for more detail on the MP component.) 2. Identifying, Reviewing, and Validating the RVUs of Potentially Misvalued Services a. Background 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 th e PFS. Section 1848(c)(2)(K) ofCMS-1612-FC 95

the Act requires the Secretary to periodically identify potentially misvalued services using certain criteria and to review and make appropria te adjustments to the relative values for those services. Section 1848(c)(2)(L) of the Act also requires the Secr etary to develop a process to validate the RVUs of certain potentially misval ued codes under the PFS, using the same criteria used to identify potentially misvalued codes, and to make appropriate adjustments.

As discussed in section I.B. of this final rule with comment period, each year we develop appropriate adjustments to the RVUs taking into account recommendati ons provided by the American Medical Association/Specialty Soci ety Relative Value Scale Update Committee (RUC), the Medicare Payment Advisory Commi ssion (MedPAC), and others. For many years, the RUC has provided us with recommendations on the appropriate relative values for new, revised, and potentially misvalued PFS services. We review these recommendations on a codeby-code basis and consider thes e recommendations in conjunction with analyses of other data, such as claims data, to inform the decision-mak ing process as authorized by the law. We may also consider analyses of work time, work RVUs , or direct PE inputs using other data sources, such as Department of Veteran 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 consid ering the most recently available data, we also assess the results of physician surveys and speci alty recommendations submitted to us by the RUC. We also consider information provided by other stakeholders. We conduct a review to assess the appropriate RVUs in the context of contemporary medi cal practice. We note that section 1848(c)(2)(A)(ii) of the Ac t authorizes the use of extra polation and other techniques to determine the RVUs for physicians’ services for which specific data are not available, in addition to taking into account the results of consultations with organizati ons representing physicians. InCMS-1612-FC 96

accordance with section 1848(c) of the Act, we de termine and make appropriate adjustments to

the RVUs. In its March 2006 Report to the Congress, MedPAC discussed the importance of appropriately valuing physicians’ services, noting that “misvalued services can distort the price signals for physicians' services as well as for ot her health care services that physicians order, such as hospital services.” In that same re port MedPAC postulated that physicians' services

under the PFS can become misvalued over time. MedPAC stated, “When a new service is added to the physician fee schedule, itmay be assigned a relatively hi gh value because of the time, technical skill, and psychological st ress 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.” We believe services can also become overvalued when PE declines. This can happen when 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. Likewi se, services can become undervalued when physician work increases or PE rises. As MedPAC noted in its March 2009 Report to Congress, in the in tervening years since

MedPAC made its initial reco mmendations, “CMS and the RUC have taken several steps to improve the review process.” Also, since that time the Congress added section 1848(c)(2)(K)(ii) to the Act, which augments our efforts. It di rects the Secretary to sp ecifically examine, as determined appropriate, potentially misvalued services in the following seven categories:

● 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;CMS-1612-FC 97

● 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 RBRVS (the so-called ‘Harvard -valued codes’); and

● Other codes determined to be appropriate by the Secretary. Section 220(c) of the Protecting Access to Medicare Act of 2014 (PAMA) further expanded the categories of codes that the Secr etary is directed to examine by adding nine additional categories. These are:

● Codes that account for the majo rity of spending under the PFS;

● Codes for services that have experienced a substantial change in the hospital length of stay or procedure time;

● Codes for which there may be a change in th e typical site of service since the code was last valued;

● Codes for which there is a significant difference in payment for the same service between different sites of service;

● Codes for which there may be anomalies in relative values within a family of codes;

● Codes for services where there may be effi ciencies when a service is furnished at the same time as other services;

● Codes with high intra-serv ice work per unit of time;

● Codes with high PE RVUs; and

● Codes with high cost supplies.CMS-1612-FC 98

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 facilitate the review and appropriate adjustme nt of potentially misvalued serv ices. This section of the Act also authorizes the use of analytic contractor s to identify and analy ze potentially misvalued codes, conduct surveys or collect data, a nd make recommendations on the review and appropriate adjustment of potentially misvalued se rvices. Additionally, this section provides that the Secretary may coordinate the review and ad justment of any RVU w ith the periodic review described in section 1848(c)(2)(B) of the Act. Section 1848(c)(2)(K )(iii)(V) of the Act specifies that the Secretary may make appropriate coding revisions (including usin g existing processes for consideration of coding changes) that may incl ude consolidation of individual services into bundled codes for payment under the physician fee schedule. b. Progress in Identifying and Revi ewing Potentially Misvalued Codes To fulfill our statutory mandate, we have identified and reviewed numerous potentially misvalued codes as specified in section 1848(c)(2)(K)( ii) of the Act, and we plan to continue our work examining potentially misvalued codes as au thorized by statute over the coming years. As part of our current process, we identify poten tially misvalued codes fo r review, and request recommendations from the RUC and other public commenters on revised work RVUs and direct PE inputs for those codes. The RUC, through it s own processes, also identifies potentially misvalued codes for review. Through our public nomination process for potentially misvalued

codes established in the CY 2012 PFS final rule with comment period, other individuals and stakeholder groups submit nominations for review of potentially misvalued codes as well.CMS-1612-FC 99

Since CY 2009, as a part of the annual potentia lly misvalued code review and Five-Year Review process, we have reviewed over 1,250 pote ntially misvalued codes to refine work RVUs and direct PE inputs. We have assigned appropr iate work RVUs and direct PE inputs for these

services as a result of these reviews. A more detailed discussion of th e extensive prior reviews of potentially misvalued codes is included in the CY 2012 PFS fi nal rule with comment period (76 FR 73052 through 73055). In the CY 2012 final rule with comment period, we finalized our 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. In the CY 2013 final rule with comment period, we built upon the work we began in CY 2009 to review potentially misvalued codes that have not been reviewed since the implementation of the PFS (so-called “Harvard-v alued codes”). In CY 2009, we requested

recommendations from the RUC to aid in our revi ew of Harvard-valued codes that had not yet been reviewed, focusing first on high-volume, lo w intensity codes (73 FR 38589). In the fourth Five-Year Review, we requested recommendations from the RUC to aid in our review of

Harvard-valued codes with annua l utilization of great er than 30,000 (76 FR 32410). In the CY 2013 final rule with comment period, we identified Harvard-valued services with annual allowed charges that total at least $10,000,000 as potentially misv alued. In addition to the Harvardvalued codes, in the CY 2013 final rule with co mment period we finalized for review a list of potentially misvalued codes that have stand-al one PE (codes with physician work and no listed work time, and codes with no physician work that have listed work time). In the CY 2014 final rule with comment period, we finalized for review a list of potentially misvalued services. We included on the list for review ultrasound guidance codes that had longer procedure times than the typical procedure with which the code is billed toCMS-1612-FC 100

Medicare. We also finalized our proposal to replace missing post-operative hospital E/M visit information and work time for approximately 100 global surgery codes. For CY 2014, we also considered a proposal to limit PFS payments for se rvices furnished in a nonfacility setting when the nonfacility PFS payment for a given service ex ceeds the combined Medicare Part B payment

for the same service when it is furnished in a facility (separate payments being made to the practitioner under the PFS and to the facility under the OPPS) . Based upon extensive public comment, we did not finalize this proposal. We address our current consideration of the potential use of OPPS data in establishing RVUs for PFS services, as well as comments received,

in section II.B. of this fina l rule with comment period. c. Validating RVUs of Po tentially Misvalued Codes Section 1848(c)(2)(L) of the Act requires the Secretary to establish a formal process to validate RVUs under the PFS. The Act specifies that the validation process may include validation of work elements (such as time, ment al effort and professi onal judgment, technical skill and physical effort, and stress due to ri sk) involved with furnishing a service and may include validation of the pre-, post-, and intra- service components of work. The Secretary is directed, as part of the valida tion, to validate a sampling of the work RVUs of codes identified through any of the 16 categories of potentia lly misvalued codes specified in section 1848(c)(2)(K)(ii)of the Act. Furthermore, the Secretary ma y conduct the validation using methods similar to those used to review pot entially misvalued codes, including conducting surveys, other data collection activities, studies, or other analyses as the Secretary determines appropriate to facilitate the va lidation 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 validation process. We provided a summary of theCMS-1612-FC 101

comments along with our responses in the CY 2011 PFS final rule with comment period (75 FR 73217) and the CY 2012 PFS final rule with co mment period (76 FR 73054 through 73055).

We contracted with two outside entities to develop valida tion models for RVUs. Given the central role of time in establishing work RVUs and the concerns that have been raised about the current time values used in rate setting, we c ontracted with the Urban In stitute to collect time data from several practices for services selected by the contractor in consultation with CMS. These data will be used to develop time estima tes. The Urban Institute will use a variety of approaches to develop objective time estimates, depending on the type of service. Objective time estimates will be compared to the current time values used in the fee schedule. The project team will then convene groups of physicians from a range of specialties to review the new time data and their potential implications for work and the ratio of work to time. The Urban Institute has prepared an interim report, Development of a Model for the Valuation of Work Relative Value Units, which discusses the challenges enco untered in collecting objective time data and offers some thoughts on how these can be overcome. This interim report is available on the

CMS website at http://www.cms.gov/Medicare/ Medicare-Fee-for-ServicePayment/PhysicianFeeSched/Downloads/RVUs -Validation-Urban Interim Report.pdf

. Collection of time data under this project has ju st begun. A final report will be available once the project is complete.

The second contract is with the RAND Corporation, which is using available data to build a validation model to predict work RVUs and the individual components of work RVUs, time, and intensity. The model design was informed by the statistical methodologies and approach used to develop the in itial work RVUs and to identify potentially misvalued procedures under current CMS and RUC processes. RAND w ill use a representative set of CMS-provided

codes to test the model. RAND consulted with a technical expert panel on model design issuesCMS-1612-FC 102

and the test results. We anticipate a report from this project by the end of the year and will make the report available on the CMS website. Descriptions of both projects are available on the CMS website athttp://www.cms.gov/Medicare/Medicare-Fee-for-ServicePayment/PhysicianFeeSched/Downl oads/RVUs-Validation-Model.pdf

. We acknowledge comments received regardi ng the Urban Institute and RAND projects,

but note that we did not solicit comments on th ese projects because we made no proposals related to them. Any changes to payment po licies under the PFS that we might make after considering these reports would be issued in a proposed rule and subjected to public comment before they would be fina lized and implemented.

3. CY 2015 Identification and Review of Potentially Misvalued Services

a. Public Nomination of Po tentially Misvalued Codes In the CY 2012 PFS final rule with comment pe riod, we finalized a process for the public to nominate potentially misvalued codes (76 FR 73058). The public and stakeholders may nominate potentially misvalued 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. Supporting do cumentation for codes nominated for the annual review of potentially misvalued codes may include the following:

● Documentation in the peer reviewed medical literature or other reli able data that there have been changes in physician work due to one or more of the following: technique; knowledge and technology; patient population; site-of-service; length of hospital stay; and work 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.CMS-1612-FC 103

● Analysis of other data on time and effort measures, such as operating room logs or national and other repres entative 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 work time, work RVU, or di rect PE inputs using ot her data sources (for example, VA NSQIP, STS National Da tabase, and the PQRS databases).

● National surveys of work time and inte nsity from professional and management societies and organizations, su ch as hospital associations.

After we receive the nominated codes duri ng the 60-day comment period following the

release of the annual PFS fina l rule with comment period, we evaluate the supporting

documentation and assess whether the nominated c odes appear to be potentially misvalued codes appropriate for review under the annual process. In the follo wing year’s PFS proposed rule, we publish the list of nominated c odes and indicate whether we ar e proposing each nominated code as a potentially misvalued code. During the comment period to the CY 2014 final rule with comment period, we received nominations and supporting documentation for four codes to be considered as potentially misvalued codes. Although we evaluated the supporting documenta tion for two of the

nominated codes to ascertain whether the submitt ed information demonstrated that the code should be proposed as potentially misvalued, we did not identify the other two codes until after the publication of the proposed rule. We apol ogize for this oversight and will address the nomination of CPT codes 92227 and 92228 in the proposed rule for CY 2016.CMS-1612-FC 104

We proposed CPT code 41530 (submucosal abla tion of the tongue base, radiofrequency, 1 or more sites, per session) as potentially misvalued based on public nomination due to a significant decrease in two of the direct PE inputs.

Comment: The commenter that nominated th is code as potentially misvalued thanked CMS for proposing this code as potentially misv alued, but indicated th at the RUC had made

recommendations for this code for CY 2015 a nd further review was no longer necessary. Another commenter suggested that this code should be remove d from the list of potentially misvalued codes since it saves Medicare millions of dollars per year. Response: The RUC only provi ded us with recommendations for PE inputs for CPT code 41530. Under our usual process, we value work a nd PE at the same time and would expect to

receive RUC recommendations on bot h before we revalue this serv ice. We disagree with the commenter’s statement that codes that may save money for the Medicare program should not be considered as potentially misvalue d. Our aim, consistent with our statutory directive, is to value all services appropriately under the PFS to reflect the relative resources involved in furnishing them. After consideration of public comments, we are finalizing CPT code 41530 as potentially

misvalued. We did not propose CPT code 99174 (instrument- based ocular screening (for example, photoscreening, automated-refraction), bilateral) as potentially misvalue d, because it is a noncovered service, and we only cons ider nominations of active codes that are covered by Medicare

at the time of the nomin ation (see 76 FR 73059). Comment: Commenters did not disagree w ith CMS not proposing this code as potentially misvalued, but did rais e a variety of comments about the code that were unrelated to our proposal.CMS-1612-FC 105

Response: We continue to believe that our policy to limit the de signation of potentially misvalued to those codes that are covered by Me dicare is appropriate, so that we focus our

limited resources on those services that have an impact on the Medicare program and its beneficiaries. Therefore, we are not including CPT code 99174 on our final list of potentially

misvalued codes for CY 2015. b. Potentially Misvalued Codes (1) Review of High Expenditure Services across Specialties with Medicare Allowed Charges of $10,000,000 or More We proposed 68 codes listed in Table 11 as potentially misvalued codes under the newly established statutory category, “codes that account for the ma jority of spending under the physician fee schedule.” To develop this list, we identified the top 20 codes by specialty (using the specialties used in Table 11) in terms of a llowed charges. We excluded those codes that we have reviewed since CY 2009, those codes with fe wer than $10 million in allowed charges, and

E/M services. E/M services were excluded for the same reason that we excluded them in a similar review for CY 2012. The reason was expl ained in the CY 2012 final rule with comment period (76 FR 73062 through 73065).

We stated that we believed that a review of the codes in Table 11 is warranted to assess changes in physician work and to update dire ct PE inputs since these codes have not been reviewed since CY 2009 or earlier. Furthermore, since these codes have significant impact on PFS payment at the specialty level, a review of the relativ ity of the codes is essential to ensure that the work and PE RVUs are appropriately rela tive within the specialty and across specialties, as discussed previously. Fo r these reasons, we proposed th e codes listed in Table 11 as potentially misvalued.CMS-1612-FC 106

TABLE 11: Potentially Misvalued Codes Identified Through the High Expenditure by Specialty Screen HCPCS Short Descriptor

11100 Biopsy skin lesion 11101 Biopsy skin add-on 11730 Removal of nail plate 11750 Removal of nail bed 14060 Tis trnfr e/n/e/l 10 sq cm/ 17110 Destruct b9 lesion 1–14 31575 Diagnostic laryngoscopy 31579 Diagnostic laryngoscopy 36215 Place catheter in artery 36475 Endovenous rf 1st vein 36478 Endovenous laser 1st vein 36870 Percut thrombect av fistula 51720 Treatment of bladder lesion 51728 Cystometrogram w/vp 51798 Us urine capacity measure 52000 Cystoscopy 55700 Biopsy of prostate 65855 Laser surgery of eye 66821 After cataract laser surgery 67228 Treatment of retinal lesion 68761 Close tear duct opening 71010 Chest x-ray 1 view frontal 71020 Chest x-ray 2vw frontal&latl 71260 Ct thorax w/dye 73560 X-ray exam of knee 1 or 2 73562 X-ray exam of knee 3 73564 X-ray exam knee 4 or more 74183 Mri abdomen w/o & w/dye 75978 Repair venous blockage 76536 Us exam of head and neck 76700 Us exam abdom complete 76770 Us exam abdo back wall comp 76775 Us exam abdo back wall lim HCPCS Short Descriptor 77263 Radiation therapy planning 77334 Radiation treatment aid(s) 78452 Ht muscle image spect mult 88185 Flowcytometry/tc add-on 91110 Gi tract capsule endoscopy 92136 Ophthalmic biometry 92250 Eye exam with photos 92557 Comprehensive hearing test 93280 Pm device progr eval dual 93306 Tte w/doppler complete 93351 Stress tte complete 93978 Vascular study 94010 Breathing capacity test 95004 Percut allergy skin tests 95165 Antigen therapy services 95957 Eeg digital analysis 96101 Psycho testing by psych/phys 96118 Neuropsych tst by psych/phys 96372 Ther/proph/diag inj sc/im 96375 Tx/pro/dx inj new drug addon 96401 Chemo anti-neopl sq/im 96409 Chemo iv push sngl drug 97032 Electrical stimulation 97035 Ultrasound therapy 97110 Therapeutic exercises 97112 Neuromuscular reeducation 97113 Aquatic therapy/exercises 97116 Gait training therapy 97140 Manual therapy 1/> regions 97530 Therapeutic activities G0283 Elec stim other than woundCMS-1612-FC 107

Comment: Many commenters disagreed with th e high expenditure screen in principle, stating that the frequency with which a service is furnished (and therefore the total expenditures)

is not an indication that the service is misval ued. Specifically, comment ers explained that many of the services are highly utilized because of th e nature of the Medicare beneficiary population,

and not because there is abuse or overutilization. Commenters asserted that the current misvalued code screens can produce a redundant list of potentially misvalued codes while failing to identify codes that are being incorrectly re ported. Another commenter urged CMS to work

with the RUC to ensure that the code lists iden tified by the misvalued code screens are accurate. A commenter asked CMS to provide justification for including codes with charges greater than $10 million on the potentially misvalued codes list. Some commenters urged us to reconsider including particular families of codes that were reviewed prior to 2009; others asked that CMS

exclude all codes that have been reviewed in the last 10 years; and still others requested that we

exclude codes that were bundled several years ago. A commenter stated that the emphasis on codes with spending of more than $10 million demonstrates an agenda to cut spending rather than to ensure appropriate payment, and expr essed concern that CMS was simply nominating high value services. Commenters recommended that CMS not finalize its proposed list of potentially misvalued codes, and instead develop a more targeted list of codes that are likely to be misvalued (not just potentially misvalued). Commenters wanted CMS to exempt codes when there have not been fundamental changes in the way the services are furnished or there is no

indication that their valu es are inaccurate, so that specialt y societies do not have to go through the work of reviewing them. Several commenters questioned the statut ory authority for CMS’s proposal. One commenter questioned CMS’s authority under the re levant statute to sele ct potentially misvaluedCMS-1612-FC 108

codes by specialty. The commenter stated that identifying the top 20 code s by specialty in terms of allowed charges does not appear to align with a direct reading of the relevant statutory authority, which allows CMS to identify codes that account for the majo rity of spending under the PFS, but does not provide for the identificatio n of codes by specialty. The commenter said that a more direct interpretation of the statut ory authority would be to select codes based on allowed charges irrespective of specialty, and then to narrow the universe of codes based upon the top codes in terms of allowed charges. A nother commenter believed the proposed screen did not comport with the statutory selection criteria because the majority or near majority of spending under the PFS is for evaluation and ma nagement (E/M) codes, which CMS excluded

from review. The commenter said that if CMS believes that E/M se rvices should not be reviewed - a position the commenter said they would certainly unders tand- then such a

determination is sufficient to meet the statut ory mandate to review codes accounting for the majority of PFS spending, and it would then be appropriate for CMS and the RUC to focus efforts on other categories of potentially misval ued codes. The commenter urged CMS at the very least to develop a more ta rgeted list of potentially misvalue d services in the category of codes accounting for the majority of PFS spending, and to include codes that are likely to be misvalued, not just potentially misvalued. Response: Potentially misvalued code scre ens are intended to id entify codes that are possibly misvalued. By definition, these screens do not assert that codes are certainly or even likely misvalued. As we discussed in the CY 2012 PFS final rule with comment period (76 FR 73056), the screens serve to focus our li mited resources on categories of codes where there is a high risk of significan t payment distortions. One goal is to avoid perpetuating payment

for the services at a rate that does not appropriately reflect th e relative resources involved in furnishing the service. In implementing this st atutory provision, we cons ider whether the codesCMS-1612-FC 109

meeting the screening criteria have a significan t impact on payment for all PFS services due to the budget neutral nature of the PFS. That is, if codes meeting th e screening criteria are indeed misvalued, they would be inappropriately impac ting the relative values of all PFS services. Addressing included codes theref ore indirectly addresses othe r codes that do not meet the screening criteria but are themselves misvalued because high expenditure codes are misvalued. We agree with the commenters that high program expenditures and high util ization have varying causes and do not necessarily reflect misvalued code s. However, we continue to believe that the high expenditure screen is neve rtheless an appropriate means of focusing our reviews, ensuring appropriate relativity among PFS services, and id entifying services that are either over or undervalued. The high expenditure screen is like ly to identify misvalue d codes, both directly and indirectly. Regarding screening for codes by specialty, as we discussed above , the included codes have significant impact on PFS payment at the specia lty level, therefore a re view of the relativity

of the codes is essential to ensure that the work and PE RVUs are appropr iately relative within the specialty and across specialties. We men tioned in the CY 2012 final rule with comment period how stakeholders have not ed that many of the services previously identified under the potentially misvalued codes initia tive were concentrated in certain specialties. To develop a robust and representative list of codes for re view, we examine the highest PFS expenditure services by specialty and we iden tify those codes that have not b een recently reviewed (76 FR 73060). Although we understand commenters’ concerns that the screens can produce redundant results, we note that we exempted codes that have been reviewed since 2009 for this very reason. We believe that the practice of medicine can change significantly over a 10-year period, andCMS-1612-FC 110

disagree with commenters’ suggestions that no changes would occur over a 10-year period that would significantly affect a procedure’s valuation. Regarding the exclusion of E/M services, we refer the commenters to the extensive

discussion in the CY 2012 PFS final rule with comment period (76 FR 73060 through 73065). It

is true that E/M services acc ount for significant volume under th e PFS, but there are significant issues with reviewing these c odes as discussed in the CY 2012 final rule with comment period, and as a result we did not propose to incl ude these codes as potentially misvalued.

Comment: Some commenters s uggested other screens that co uld be used to identify misvalued codes. In addition, even though our pr oposal only relates to identifying potentially misvalued codes, some commenters commented on our mechanisms for re-valuing misvalued

codes. Response: The only screen for which we made a proposal and sought comments was the high expenditure screen. However, we will cons ider the suggestions for other screens as we develop proposals in future years. Similarly, our proposal only related to identifying potentially

misvalued codes and not how to re-v alue them if they were finaliz ed as potentially misvalued. Comment: Several commenters requested th at CMS postpone the review of potentially misvalued codes until the revised process we proposed for reviewing new, revised, and potentially misvalued codes is in place. Response: Although we believe that the revi sed process for review ing new, revised, and potentially misvalued codes will improve the tran sparency of the PFS code review process, we do not believe it is appropriate to postpone the review of all pote ntially misvalued codes until the new process is implemented. We note that th e codes identified in this rule as potentially misvalued would be revalued under the new proce ss, which will be phased in starting for CY 2016 and will apply for all codes revalued for CY 2017.CMS-1612-FC 111

Comment: Commenters raised several codes that they believ ed should not be included in the high expenditure screen for a variety of reason s, for example if the co de is related to other codes that were recently reviewed and the utilizat ion for the identified service is expected to change significantly as a result of coding changes in the family. Commenters also suggested that

codes that have been referred to the CPT Editorial Panel should be excluded from the potentially

misvalued codes list. Response: We acknowledge commenters’ sugge stion that we exclude particular codes from the screen, but since we are not finalizing a particul ar list of codes for this screen in this

final rule we are not addressi ng these at this time. We not e that we do not agree with

commenters that codes that have been referred to CPT by the RUC should be excluded from the potentially misvalued list; rather, we believe th at only when these codes are either deleted or revised, and/or we receive new RUC recommenda tions for re-valuing these codes, would it be appropriate to remove these services from the list. Comment: A commenter suggested that CMS’ s high expenditure screen may not account for the fact that many radiology codes have al ready gone through numerous five-year reviews; have well-established RVUs that are included on the RUC’s multispecialty point of comparison (MPC) list; have been included in new, bundled codes; or have PE RVUs that were affected by changes in clinical labor times or equipment utilization assumption changes. The commenter also suggested that the screens do not account for the value that patients receive in terms of better, timelier diagnoses and avoi dance of invasive procedures. Response: We acknowledge that certain t ypes of procedures have been identified through multiple screens; however, we continue to be lieve that it is appropriate to include most

codes that are identified via these screens and not to exclude codes simply because many other procedures furnished by that specialty have alre ady been reviewed. We further note that theCMS-1612-FC 112

presence of codes on the MPC list makes the case for their review more compelling, given their importance in ensuring overall relativity througho ut the PFS. With respect to changes in PE RVUs, we note that cross-cutti ng policies that affect large numbers of codes are aimed at ensuring overall relativity but do not address the inputs associated with each procedure affected by the change. Finally, a code’s status as poten tially misvalued does not imply that the service itself is not of inherent value; rather, that its valuation may be inaccurate in either direction. After considering the comment s received, as well as the ot her proposals we are finalizing, we believe it is appropriate to finalize the high expenditure screen as a tool to identify potentially misvalued codes. However, given the resources required over the next se veral years to revalue the services with global periods , we believe it is best to c oncentrate our efforts on these valuations. Therefore, we are not finalizing the codes identifi ed through the high expenditure screen as potentially misvalued at this time. Also, we are not respondi ng to comments at this time regarding whether particular codes should or should not be included in the high expenditure code screen and identified as potentially misvalued codes. We will re-run the high expenditure screen at a future date, and will propose at that ti me the specific set of codes to be reviewed that meet the high expenditure criteria. (2) Epidural Injection an d Fluoroscopic Guidance

− CPT Codes 62310, 62311, 62318, 62319, 77001, 77002 and 77003 For CY 2014, we established interim final rate s for four epidural injection procedures, CPT codes 62310 (Injection(s), of diagnostic or th erapeutic substance(s) (including anesthetic, antispasmodic, opioid, steroid, ot her solution), not including neur olytic substances, including needle or catheter placement, includes contrast for localization when performed, epidural or subarachnoid; cervical or thoracic ), 62311 (Injection(s), of diagnosti c or therapeutic substance(s) (including anesthetic, antispasm odic, opioid, steroid, other solution), not including neurolyticCMS-1612-FC 113

substances, including needle or catheter placemen t, includes contrast for localization when performed, epidural or subarachnoid; lumbar or sacral (caudal)), 62318 (Injection(s), including indwelling catheter placement, continuous infusi on or intermittent bolus, of diagnostic or therapeutic substance(s) (incl uding anesthetic, antispasmodic, opi oid, steroid, other solution), not including neurolytic substances, includes contrast for localizati on when performed, epidural or subarachnoid; cervical or thoracic) and 62319 (Injection(s), including indwelling catheter placement, continuous infusion or intermittent bolus, of diagnostic or therapeutic substance(s) (including anesthetic, antispasm odic, opioid, steroid, other solution), not including neurolytic substances, includes contrast for localization whenperformed, epidural or subarachnoid; lumbar or sacral (caudal)). These interim final values resulted in CY 2014 payment reductions from the CY 2013 rates for all four procedures. In the CY 2014 final rule with comment period (78 FR 74340), we described in detail our

interim valuation of these codes. We indicated we established interim final work RVUs for these codes that were less than those recommended by the RUC because we did not believe that the

RUC-recommended work RVUs accounted for the s ubstantial decrease in time it takes to furnish these services as reflected in the RUC survey da ta for these four codes. Since the RUC provided no indication that the intensity of the procedures had changed, we indicated that we believed the

work RVUs should reflect the reduction in time. We also established interim final direct PE inputs for these four codes based on the RUC -recommended inputs without any refinement.

These recommendations included the removal of the radiographic-fluoroscopy room for CPT codes 62310, 62311, and 62318 and a portable C-arm for CPT code 62319. In response to the comments we received obj ecting to the CY 2014 interim final values for these codes, we looked at other injection pr ocedures. Other injectio n procedures, including

some that commenters recommended we use to valu e these epidural injection codes, include theCMS-1612-FC 114

work and practice expenses of image guidance in the injection code. In the proposed rule, we detailed many of these procedures, which include the image guidance in th e injection CPT code. Since our analysis of the Medicare data and comments received on the CY 2014 final rule with comment period indicated that thes e services are typically furnis hed with imaging guidance, we believe it would be appropriate for the codes to be bundled and the inputs for image guidance to

be included in the valuation of the epidural injection codes as it is for transforaminal and paravertebral codes. We stated that we did not believe the ep idural injection codes can be appropriately valued without considering the im age guidance, and that bundling image guidance will help assure relativity with other injection codes that include the image guidance. To determine how to appropriately value resources fo r the combined codes, we indicated that we

believed more information is needed. Acco rdingly, we proposed to include CPT codes 62310, 62311, 62318, and 62319 on the potentially misvalued code list so that we can obtain information to value them with the image guidance included. In the meantime, we proposed to use the CY 2013 input values for CPT codes 62310, 62311, 62318 and 62319 to value these codes for CY 2015. Specifically, we proposed to use the CY 2013 work RVUs and work times. Because it was clear that inputs that are spec ifically related to im age guidance, such as the radiographic fluoroscopic room , are included in these propos ed direct PE inputs for the epidural injection codes, we believed allowing separate report ing of the image guidance codes

would overestimate the resources used in furnishi ng the overall service. To avoid this situation, we also proposed to prohibit th e billing of image guidance codes in conjunction with these four epidural injection codes. We stated that we believed our tw o-tiered proposal to utilize CY 2013 input values for this family while prohibiting se parate billing of imaging guidance best ensures that appropriate reimbursements continue to be made for these services, while we gather additional data and input on the best way to value them through codes that include both theCMS-1612-FC 115

injection and the image guidance. Comment: The commenters did not object to identifying these c odes as potentially misvalued and generally agreed with our propos al to revert to the 2013 inputs for CY 2015. Response: We appreciate support for our proposal. Comment: Several commenters agreed that it would be appropriate to bundle the image guidance with the epidural procedures. Othe r commenters suggested that we create both a

bundled code and a stand-alone epidural injection code. Response: We appreciate commenters’ s upport for our propos al to bundle image guidance with the epidural procedures. As part of the review process, co nsideration can be given to how to best implement bundled codes. Comment: Other commenters expressed c oncern that the bundling approach CMS proposed to use until these codes are reviewed did not incorporate th e work or time for fluoroscopy. Some requested that we add the pa yment for fluoroscopic guidance to the epidural injection codes, as we have done in the past for facet joint injections and other services. Commenters requested that we continue to al low the image guidance codes to be separately

billed until these services are revalued. Anothe r commenter suggested that it may be premature to prohibit separate billing for image guidance, as there is considerable variation on the use of fluoroscopic guidance between codes within this family. Response: We understand comment ers’ concerns about our pr oposal to prohibit separate billing for image guidance, and note that these c oncerns are part of the reason we are referring these codes to the RUC as potentially misvalued. However, given that si gnificant resources are allocated to fluoroscopic guidance within the cu rrent injection codes, we do not believe it is appropriate to continue to allo w the image guidance to be separa tely billed while we evaluate these epidural injection codes as potentially misvalued services.CMS-1612-FC 116

After considering comments received, we are finalizing CPT codes 62310, 62311, 62318, and 62319 as potentially misvalued, finalizing the proposed RVUs for these services, and prohibiting separate billing of image guida nce in conjunction with these services. (3) Neurostimulator Implantation (CPT codes 64553 and 64555) We proposed CPT codes 64553 (Percutaneous im plantation of neurostimulator electrode array; cranial nerve) and 64555 (Percutaneous impl antation of neurostimulator electrode array; peripheral nerve (excludes sacral nerve)) as pote ntially misvalued after stakeholders questioned whether the codes included the appropriate dir ect PE inputs when furnished in the nonfacility setting. Comment: A commenter encouraged CMS to include these codes on the potentially misvalued code list to ensure that they are adeq uately reimbursed in the nonfacility setting, while another commenter disagreed that the work for CPT codes 64553 and 64555 needed to be

reviewed. Response: In general, when a code is proposed as potentially misvalued, unless we receive information that clearly demonstrates it is not potentially misvalued, we finalize the code as potentially misvalued. When we finalize a code as potentia lly misvalued, we then review the inputs for the code. As a result of such re view, inputs can be adjusted either upward or

downward. We appreciate the support for our proposal expressed by some commenters. Since the commenter opposing the addition of these codes to the potentially misvalued code list did not provide justification for its assertion that the work RVUs for CPT codes 64553 and 64555 did not need to be reviewed, after consideration of comments receiv ed, we are finalizing CPT codes 64553 and 64555 as potentially misvalued. (4) Mammography (CPT codes 77055, 77056, and 77057, and HCPCS codes G0202, G0204, andCMS-1612-FC 117

G0206) Medicare currently pays for mammogra phy services through both CPT codes, (77055 (mammography; unilateral), 77056 (mammogr aphy; bilateral) and 77057 (screening mammography, bilateral (2-view film study of each breast)) and HCPCS G-codes, (G0202 (screening mammography, producing direct digital image, bilateral, all views), G0204 (diagnostic mammography, producing direct digital image, bilateral, all views), and G0206 (diagnostic mammography, producing di rect digital image, unilatera l, all views)). The CPT codes were designed to be used for mammograp hy regardless of whether film or digital technology is used. However, for Medicare pu rposes, the HCPCS G-codes were created to describe mammograms using digita l technology in response to speci al payment rules for digital mammography included in the Medicare Benef it Improvements and Protection Act of 2000 (BIPA). The RUC recommended that CMS update the di rect PE inputs for all imaging codes to reflect the migration from film -to-digital storage technologies since digital storage is now typically used in imaging services. Review of th e Medicare data with regard to the application of this policy to mammography confirmed that vi rtually all mammography is now digital. As a result, we proposed that CPT codes 77055, 77056, and 77057 be used to report mammography regardless of whether film or digital technology is used, and to delete the HCPCS G-codes G0202, G0204, and G0206. We proposed to establis h values for the CPT codes by crosswalking

the values established for the digital mammography G-codes for CY 2015. (See section II.B. of this final rule with comment period for more disc ussion of this policy.) In addition, since the Gcode values have not been eval uated since they were created in CY 2002 we proposed to include CPT codes 77055, 77056, and 77057 on the list of potentially misvalued codes. Comment: With regard to whether the mammography codes should be included on theCMS-1612-FC 118

potentially misvalued codes list, commenters had differing opinions. One commenter stated that the work RVUs for digital mammography are th e same as those for analog mammography, and maintained that the BIPA-directed payment for digital mammography of 1.5 times the TC of the analog mammography codes appropri ately captures the practice e xpense resources required for digital mammography. Another commenter stated that digital mammography rates resulted from a statutory construct and do not reflect the actual costs of the digital resources necessary to

furnish the services. One commenter noted that moving from the non-res ource-based values to resource-based values will result in a significant reduction to the valuation of these services, and

that this reduction will result from the re source-based PE methodology, not from the RUC

review. Another commenter indica ted that the RUC should not surv ey these codes, but requested that if the RUC does survey these codes, they should not do so until after CMS finalizes the new breast tomosynthesis codes (3D mammography) and film-to-digital transition. Another

commenter indicated that CMS needed to cons ider that three-dimensional (3D) mammography

codes involve additional resour ces over the two-dimensiona l (2D) mammography codes. A commenter suggested that this proposal fails to take into account the increasing use of tomography. Response: The commenters’ disagreement about whether these codes are misvalued would suggest that a review is warranted. Given that more than a decade has passed since these services were reviewed, we continue to believe th at it is appropriate to review the work RVUs for these services. By including these codes on th e potentially misvalued code list, we will have

information to determine whether the current valu es are still appropriate. Finally, we anticipate that the survey results for the mammography code s will reflect the equipm ent that is typically

used. We note that until thes e services are reviewed, we do not have adequate information to respond to the suggestion that th e valuation for these services will be significantly reduced.CMS-1612-FC 119

However, we do acknowledge that the PE met hodology is not intended to account for the actual costs in furnishing a service; rather, it is required to account for the relative resources in furnishing that service. We also note that there are new CPT codes for reporting mammography using tomosynthesis and we have RUC recommendations for these c odes. We believe it is most appropriate to value the ma mmography code family toge ther, and receipt of RUC recommendations on the other mammography codes w ill assist us in our review. Accordingly, we are including all mammography codes except those newly created for tomosynthesis on the potentially misvalued code list. Comment: Although commenters agreed with our assessment that digital technology has replaced analog mammography as typical, not all agreed that it was appr opriate to delete Gcodes and use the CPT codes. One commenter supported the deletion of the G-codes. Other commenters suggested that deleti on of the G-codes was unnecessar y. Another commenter stated that the coding system frequently reflects differences in appro ach and technique, and that the equipment for analog and digital mammography are different enough to warrant separate reporting so we should not delete the G-codes. Some who suppor ted continuation of the G-codes asked us to delay implementation as they were c oncerned that other payers would not have time to update their requirements by January 1, 2015. Another comment er applauded CMS’s decision

to delete the G-codes. Response: In further consideration this pr oposal, we discovered that while the CPT codes for diagnostic mammography apply to mammogra phy, whether film or digital technology is used, the descriptor for the screening mammogra phy CPT code specifically refers to film. In light of this and that fact that we anticipate revaluing these c odes when we have the benefit of RUC recommendations for all codes in the family, we believe it is appropriate to continue to recognize both the CPT codes and the G-codes for mammography for CY 2015, as we considerCMS-1612-FC 120

appropriate valuations now that digital mammography is typical. Therefore, we are not finalizing our proposal to delete the G-codes. We are, however, making a change in the descriptors to make clear that the G0202, G 0204, and G0206 are specific to 2-D mammography. These codes are to be reported with either G0279 or CPT code 77063 when mammography is furnished using 3-D mammography. Comment: A commenter requested that CMS ensure reimbursement rates remain adequate to protect access for Me dicare beneficiaries. Another commenter suggested that these changes could result in barriers to access for Medicare beneficiaries. Response: We are strongly supportive of access to mammography for Medicare

beneficiaries. As stated else where in this final rule with comment period, we believe that accurate valuation incentivizes appr opriate utilization of services. After consideration of public comments, we are modifying our propos al as follows: we will include CPT codes 77055, 77056, and 77057 on the potentially misvalued codes list; we will continue to recognize G0202, G0204 and G0206 but will modify the descriptors so that they are specific to 2-D digital mammography, and instead of using the digital values we will continue to

use the CY 2014 work and PE RVUs to value the mammography CPT codes. We expect that the

CPT Editorial Panel will consider the desc riptor for screening mammography, CPT code 77057, in light of the prevailing use of digital mammography. (5) Abdominal Aortic Aneurysm Ultrasound Screening (G0389) When Medicare began paying for abdomi nal aortic aneurysm (AAA) ultrasound screening, HCPCS code G0389 (Ultr asound, B-scan and/or real time with image documentation; for abdominal aortic aneurysm (A AA) screening) in CY 2007, we se t the RVUs at the same level as CPT code 76775 (Ultrasound, retroperitoneal (e.g., renal, aorta, nodes), B-scan and/or real time with image documentation; limited). We noted in the CY 2007 final rule with commentCMS-1612-FC 121

period that CPT code 76775 was used to report the service when furnished as a diagnostic test and that we believed the service reflected by G0389 used equivalent resources and work intensity

to those contained in CPT c ode 76775 (71 FR 69664 through 69665). In the CY 2014 proposed rule, we proposed to replace the ultrasound room included as a direct PE input for CPT code 76775 with a portable ultrasound unit based upon a RUC

recommendation. Since the RVUs for G0389 were crosswalked from CPT code 76775, the proposed PE RVUs for G0389 in the CY 2014 proposed rule were reduced as a result of this change. However, we did not discuss the applic ability of this change to G0389 in the preamble to the proposed rule, and did not receive any comments on G0389 in response to the proposed rule. We finalized the change to CPT code 76775 in the CY 2014 final rule with comment period and as a result, the PE R VUs for G0389 were also reduced. We proposed G0389 as potentially misvalued in response to a stakeholder suggestion that

the reduction in the RVUs for G0389 did not ac curately reflect the resources involved in furnishing the service. We sought recommenda tions from the public an d other stakeholders, including the RUC, regarding the appropriate work RVU, time, di rect PE input, and malpractice risk factors that reflect the typical resour ces involved in furnishing the service. Until we receive the information needed to re-value this service, we proposed to value this code using the same work and PE RVUs we used for CY 2013. We proposed MP RVUs based on the five-year review update process as described in secti on II.C of this final rule with comment period. We stated that we believe this valuation would am eliorate the effect of the CY

2014 reduction that resulted from the RVUs for G 0389 being tied to those for another code while we assess appropriate valuation through our usual methodologies. Accordingly, we proposed a work RVU of 0.58 for G0389 and proposed to assi gn the 2013 PE RVUs until this procedure is

reviewed.CMS-1612-FC 122

Comment: Many commenters supported our pr oposal to include this service on the potentially misvalued codes list. Some commenter s agreed that the crosswalk used to set rates for this service does not appear to be appropriate at this time, wh ether due to changes in the way the service is provided, or because the specialty mix has shifted, and suggested that it would be appropriate to establish a Cate gory I CPT code for this servic e. Another commenter suggested that CMS consider crosswalking G0389 to CPT code 93979 (Duplex scan of aorta, inferior vena cava, iliac vasculature, or bypass grafts; unilate ral or limited study). One commenter believed it was unnecessary to survey this code, but reco mmended that we instead maintain the general ultrasound room as a direct PE input and 2013 PE RVUs. Response: We appreciate commenters’ support for our proposal to include G0389 on the potentially misvalued codes list and are finalizing this proposal. We are finalizing this code as potentially misvalued in large part because we ar e unsure of the correct va luation. Therefore, we believe it is most appropriate to retain th e 2013 inputs until we receive new recommendations, rather than making another change or retaini ng these inputs indefinitely as commenters suggested. After consideration of comments received, we are finalizing our proposal to add G0389 to the potentially misvalued codes list, and to maintain the 2013 work and PE RVUs while we complete our review of the code. The MP RVUs will be calculated as discussion in section II.C.

of this rule. (6) Prostate Biopsy Codes – (HCPCS codes G0416, G0417, G0418, and G0419) For CY 2014, we modified the code descri ptors of G0416 through G0419 so that these codes could be used for any method of prostate needle biopsy services, rather than only for prostate saturation biopsies. Th e CY 2014 descriptions are:CMS-1612-FC 123

● G0416 (Surgical pathology, gross and micros copic examination for prostate needle biopsies, any method; 10–20 specimens).

● G0417 (Surgical pathology, gross and micros copic examination for prostate needle biopsies, any method; 21–40 specimens).

● G0418 (Surgical pathology, gross and micros copic examination for prostate needle biopsies, any method; 41–60 specimens).

● G0419 (Surgical pathology, gross and micros copic examination for prostate needle biopsies, any method; greater than 60 specimens). Subsequently, we have discussed prostate biopsies with stakehol ders, and reviewed

medical literature and Medicare cl aims data in considering how be st to code and value prostate biopsy pathology services. After considering these di scussions and information, we believed it would be appropriate to use onl y one code to report prosta te biopsy pathology services. Therefore, we proposed to revise the descriptor for G0416 to defi ne the service regardless of the number of specimens, and to delete codes G0417, G0418, and G0419. We believe that using G0416 to report all prostate biopsy pathology serv ices, regardless of the number of specimens, would simplify the coding and mitigate overutilization incentives. Given the infrequency with which G0417, G0418, and G0419 are used, we did not be lieve that this was a significant change.

Based on our review of medical literature and examination of Medicare claims data, we

indicated that we believe that the typical number of specimens ev aluated for prostate biopsies is between 10 and 12. Since G0416 currently is used for between 10 and 12 specimens, we proposed to use the existing values for G0416 for CY 2015, since the RVUs for this service were established based on similar assumptions. In addition, we proposed G0416 as a potential ly misvalued code for CY 2015 and sought public comment on the appropriate work RVUs , work time, and direct PE inputs.CMS-1612-FC 124

Comment: One commenter supported the e limination of the G-codes as a means of simplifying coding requirements, but other comme nters opposed our proposa l to consolidate the coding into G0416, disagreeing that this would help establish “straightforward coding and maintain accurate payment” as suggested in the proposed rule. Some comm enters suggested that we retain the current codes so that biopsy proc edures requiring more than 10 specimens can be reimbursed accurately, and indicated that cons olidating the coding would further confuse physicians and their staff who have not yet adap ted to the CY 2014 coding changes for these Gcodes. Other commenters asserted that thes e changes threaten to undermine access to high quality pathology services. Commenters also stat ed that the decision to furnish more extensive pathological analysis is not at the discretion of the pathologist, and the pathologist should not be penalized when he or she receives more cores to analyze. With respect to our proposing G0416 as pot entially misvalued, comme nters stated that the recent change to thes e codes has already been confusing a nd suggests that there is not a clear understanding of what these code s represent, thus making an assessment of their valuation

difficult. Commenters further stated that it is unreasonable to consider this a misvalued code when the payment is already 30 percent below wh at they think it should be, and that CMS has failed to provide justification for why it is potentially misvalued. The RUC and others suggested that it woul d be most accurate to utilize CPT code 88305 (Level IV - surgical pathology, gr oss and microscopic examination) for the reporting of prostate biopsies and to allow the reporting of multiple units. Given the additional granularity and scrutiny given to CPT code 88305 in the CY 2014 fina l rule, the commenters indicated that they believe that the agency’s intent to establish straightforward coding and accurate payment for

these services would be real ized with this approach.CMS-1612-FC 125

Response: Given that the typical analysis of prosta te biopsy specimens differs significantly from the typical an alyses reported using CPT code 88305, as regards the number of blocks used to process the specimen and thus th e amount of work involved, we believe that by distinguishing prostate biopsies from other types of biopsies results in more accurate pricing for prostate biopsies. Since CPT code 88305 was re valued with the understanding that prostate biopsies are billed separatel y, we believe that allowing CP T code 88305 to be reported in multiple units for prostate biopsies would accoun t for significantly more resources than is appropriate. With respect to the concern about higher numbers of specimens, we note that our

claims data on the G-codes shows that the vast majority of the claims used G0416, rather than any of the G-codes for greater numbers of specimens. After consideration of comments received, we are finalizing our proposal to include G0416 on the potentially misvalued c odes list, to modify the descri ptor to reflect all prostate biopisies, and to maintain the current value until we receive and review information and

recommendations from the RUC. We are also finalizing our proposal to delete codes G0417, G0418, and G0419. (7) Obesity Behavioral Group Counseling – GXXX2 and GXXX3 Pursuant to section 1861(ddd) of the Act, we added coverage for a new preventive benefit, Intensive Behavioral Therapy for Obesity, effective November 29, 2011, and created HCPCS code G0447 (Face-to-face behavioral couns eling for obesity, 15 minutes) for reporting and payment of individual behavi oral counseling for obesity. Cove rage requirements specific to

this service are delinea ted in the Medicare National Covera ge Determinations Manual, Pub. 100– 03, Chapter 1, Section 210, available at http://www.cms.gov/manuals/downloads/ncd103c1_Part4.pdf

.CMS-1612-FC 126

It was brought to our atten tion that behavioral counseling for obesity is sometimes furnished in group sessions, and questions were raised about whether gr oup sessions could be billed using HCPCS code G0447. To improve pa yment accuracy, we proposed to create two new HCPCS codes for the reporting and payment of group behavioral counseling for obesity. Specifically, we proposed to create GXXX2 (F ace-to-face behavioral counseling for obesity, group (2-4), 30 minutes) and GXXX3 (Face-to-face behavioral c ounseling for obesity, group (5- 10), 30 minutes). We indicated that the coverage requirements for these services would remain in place, as described in the National Coverage Determination for Intensive Behavioral Therapy for Obesity cited above. The practitioner furnis hing these services woul d report the relevant group code for each beneficiary partic ipating in a group therapy session.

Since we believed that the face-to-face be havioral counseling for obesity services described by GXXX2 and GXXX3 would require similar per minute work and intensity as HCPCS code G0447, we proposed work RVUs of 0.23 and 0.10 for HCPCS codes GXXX2 and GXXX3, with work times of 8 minutes and 3 minutes respectively. Since the services described by GXXX2 and GXXX3 would be billed per benefici ary receiving the serv ice, the work RVUs and work time that we proposed for these code s were based upon the assumed typical number of beneficiaries per session, 4 and 9, respectively. Accordingly, we proposed a work RVU of 0.23

with a work time of 8 minutes for GXXX2 and a work RVU of 0.10 with a work time of 3 minutes for GXXX3. We proposed to use th e direct PE inputs for GXXX2 and GXXX3 currently included for G0447 prorated to accoun t for the differences in time and number of beneficiaries, and to crosswalk the malpracti ce risk factor from HCPCS code G0447 to both HCPCS codes GXXX2 and GXXX3, as we believe the same specialty mix will furnish these services. We requested public comment on th e proposed values for HCPCS codes GXXX2 and

GXXX3.CMS-1612-FC 127

Comment: Commenters generally supported our proposal to establish a separate payment mechanism for obesity behavioral group counse ling services, but rais ed several concerns regarding the coding structure and valuation of these services. Commenters stated that the work times were inaccurate, requested that the service be valued based on a smaller number of typical group participants, and questioned the need fo r two G-codes when group counseling services under the PFS are generally billed with a single G-c ode. A commenter also stated that the lower payment for larger groups will create disincentives for furnishing this service except when there is a full 10-person group, which could limit acces s. Commenters suggested that CMS only finalize a single G-code for group counseling for intensive behavioral therapy for obesity, and

crosswalk the work RVU and work time for this service from the Medical Nutrition Therapy (MNT) group code. Response: We appreciate comm enters’ support for our propos al to provide new codes for group obesity counseling services. After reviewing the comments, we agree that it is reasonable to create a single code for gr oup obesity counseling and crosswalk the work RVU and work time from the MNT group code. The individual code fo r intensive obesity behavioral therapy and the individual MNT code are valued the same, so in the absence of evidence that group composition is different, we believe it makes sense to use th e same values. Therefore, we will crosswalk the

work RVU of 0.25 and the work time of 10 minutes to a single new G-code for group obesity counseling, G0473 (Face-to-f ace behavioral counseling for obesity, group (2-10), 30 minutes). 4. Improving the Valuation and Coding of the Global Package

a. Overview Since the inception of the PFS, we have valued and paid for certain services, such as surgery, as part of global packages that include the procedure and the services typically furnished in the periods immediately befo re and after the procedure (56 FR 59502). For each of theseCMS-1612-FC 128

codes (usually referred to as global surgery codes), we establish a single PFS payment that includes payment for particular services that we assume to be typically furnished during the established global period. There are three primary categories of globa l packages that are labeled based on the number of post-operative days included in th e global period: 0-day; 10-day; and 90-day. The 0-day global codes include the surgical proc edure and the pre-operative and post-operative physicians’ services on the day of the procedure, including visits related to the service. The 10-day global codes include these services and, in addi tion, visits related to the procedure during the 10 days following the procedure. The 90-day global codes include the same services as the 0-day global codes plus the pre-op erative services furnished one day prior to the procedure and post-operative services during the 90 days imme diately following the day of the procedure.

Section 40.1 of the Claims Pro cessing Manual (Pub. 100–04, Chapter 12 Physician/Nonphysician Practitioners) defines th e global surgical package to include the following services when furnishe d during the global period:

● Preoperative Visits

− Preoperative visits after the decision is made to operate beginning with the day before the day of surgery for major procedures and the day of surgery for minor procedures;

● Intra-operative Services

− Intra-operative services th at are normally a usual and necessary part of a surgical procedure;

● Complications Following Surgery

− All additional medical or surgical services required of the surgeon during th e postoperative period of the surgery because of complications that do not require additional trips to the operating room;

● Postoperative Visits

− Follow-up visits during the postope rative period of the surgery that are related to recovery from the surgery;CMS-1612-FC 129

● Postsurgical Pain Management

− By the surgeon;

● Supplies

− Except for those identified as exclusions; and

● Miscellaneous Services

− Items such as dressing changes; local incisional care; removal of operative pack; removal of cutaneous su tures and staples, lines, wires, tubes, drains, casts, and splints; insert ion, irrigation and removal of urin ary catheters, routine peripheral intravenous lines, nasogastric and rectal tubes; and changes and re moval of tracheostomy tubes. b. Concerns with the 10- and 90-Day Global Packages CMS supports bundled payments as a mechan ism to incentivize hi gh-quality, efficient care. Although on the surface, the PFS global codes appear to function as bundled payments similar to those Medicare uses to make single payments for multiple serv ices to hospitals under the inpatient and outpatient prospective payment syst ems, the practical reality is that these global codes function significantly differe ntly than other bundled payments. First, the global surgical codes were established several decades ago when surgical follow-up care was far more homogenous than today. Today, there is more di versity in the kind of procedures covered by global periods, the settings in which the procedures and the follow-up care are furnished, the health care delivery system and business arrange ments used by Medicare practitioners, and the care needs of Medicare beneficiaries. Despite th ese changes, the basic st ructures of the global surgery packages are the same as the packages th at existed prior to the creation of the resourcebased relative value system in 1992. Another significant difference between this and other typical models of bundled payments is that the pa yment rates for the global surgery packages are not updated regularly based on any reporting of the act ual costs of patient car e. For example, the hospital inpatient and outpatient prospective pa yment systems (the IPPS and OPPS, respectively) derive payment rates from hospital cost and charge data reported through annual MedicareCMS-1612-FC 130

hospital cost reports and the most recent year of claims data available for an inpatient stay or primary outpatient service. Because payment rates are based on consiste ntly updated data, over time, payment rates adjust to reflect the average resource costs of current practi ce. Similarly, many of the new

demonstration and innovation models track costs and make adjustments to payments. Another significant difference is that payment for the PFS gl obal packages relies on valuing the combined services together. This means that there are no separate PFS values established for the procedures or the follow-up care, making it difficult to estimate the costs of the individual global code component services. In the following paragraphs, we address a seri es of concerns regarding the accuracy of payment for 10- and 90- day global codes, including: the fundamen tal difficulties in establishing appropriate relative values for these packages , the potential inaccuracies in the current information used to price global codes, the lim itations on appropriate pricing in the future, the potential for global packages to create unwarra nted payment differentials among specialties, the possibility that the current codes are incompa tible with current medical practice, and the potential for these codes to present obstacle s to the adoption of new payment models. Concerns such as these commonly arise when developing payment mechanisms, for example fee-for-service payment rates, single pa yments for multiple services, or payment for episodes of care over a period of ti me. However, in the case of the post-operative portion of the 10- and 90-day global codes, we believe that toge ther with certain unique aspects of PFS rate setting methodology, these concerns create substantial barriers to accurate valuation of these

services relative to other PFS services. (1) Fundamental Limitations in the Appropriate Valuation of the Global Packages with Postoperative days.CMS-1612-FC 131

In general, we face many challenges in valui ng PFS services as accurately as possible. However, the unique nature of global surger y packages with 10- and 90-day post-operative periods presents additional challenges distin ct from those presented in valuing other PFS services. Our valuation methodology for PFS services generally relies on assumptions regarding the resources involved in furnishing the “typical case” for each individua l service unlike other payment systems that rely on actual data on the cost s of furnishing services. Consistent with this valuation methodology, the RVUs for a global code should reflect the typical number and level

of E/M services furnished in connection with th e procedure. However, it is much easier to maintain relativity among services that are valued on this basis when each of the services is described by codes of similar unit sizes. In othe r words, because codes with long post-operative periods include such a large number of services , any variations between the “typical” resource

costs used to value the service and the actual resource costs associ ated with particular services are multiplied. The effects of this problem can be two-fold, skewing the accuracy of both the RVUs for individual global codes and the Medica re payment made to individual practitioners. The RVUs of the individual globa l service codes are skewed whenev er there is any inaccuracy in the assumption of the typical number or kind of services in the post-operative periods. This inaccuracy has a greater impact than inaccuracies in assumptions for non-global codes because it affects a greater number of service units over a period of time than for individually priced services. Furthermore, in contrast to prospect ive payment systems, such inaccuracies under the PFS are not corrected over time through a rate setting process that makes year-to-year adjustments based on data on actual costs. For exam ple, if a 90-day global code is valued based on an assumption or survey response that ten post- operative visits is typi cal, but practitioners reporting the code in fact typically only furnis h six visits, then the resource assumptions are overestimated by the value of the four visits mu ltiplied by the number of the times the procedureCMS-1612-FC 132

code is reported. In contrast, when our assu mptions are incorrect about the typical resources involved in furnishing a PFS code th at describes a single service, any inaccur acy in the RVUs is

limited to the difference between the resource costs assumed for the typical service and the actual resource costs in furnishing one individua l service. Such a variation between the assumptions used in calculating payment rates and the actual resource cost s could be corrected if the payments for packaged services were upda ted regularly using data on actual services furnished. Medicare’s prospective payment syst ems have more mechanisms in place than the PFS does to adjust over time for such variation To make adjustments to the RVUs to account for inaccurate assumptions under th e current PFS methodology, the globa l surgery code would need to be identified as potentially misvalued, survey data would have to reflect an accurate account of the number and level of typical post-operative visi ts, and we (with or without a corresponding recommendation from the RUC or others) would have to implement a change in RVUs based on the change in the number and level of vis its to reflect the typical service. These amplified inaccuracies may also occur whenever Medicare pays an individual practitioner reporting a 10- or 90-day global code. Practitioners may furnish a wide range of post-operative services to indivi dual Medicare beneficiaries, depending on indi vidual patient needs, changes in medical practice, and dynamic business models. Due to the way the 10- and 90-day global codes are constructed, the number a nd level of services in cluded for purposes of calculating the payment for these services may vary greatly from the number and level of services that are actually furnished in any partic ular case. In contrast, the variation between the “typical” and the actual resource cost for the practitioner reporting an individually valued PFS

service is constrained because the practitioner is onl y reporting and being paid for a specific service furnished on a particular date.CMS-1612-FC 133

For most PFS services, any difference betw een the “typical” case on which RVUs are based and the actual case for a particular service is limited to the variation between the resources assumed to be involved in furnishing the typi cal case and the actual re sources involved in furnishing the single specific service. When th e global surgical package includes more or a higher level of E/M services than are actually furnished in the typical post-operative period, the Medicare payment is based on an overestimate of the quantity or kind of services furnished, not merely an overestimation of the resources involv ed in furnishing an individual service. The converse is true if the RVUs for the global surgi cal package are based on fewer or a lower level of services than are typically furn ished for a particular code. (2) Questions Regarding Accur acy of Current Assumptions In previous rulemaking (77 FR 68911 through 68913), we acknowledged evidence suggesting that the values included in the post- operative period for globa l codes may not reflect the typical number and level of post-opera tive E/M visits actually furnished. In 2005, the OIG examined whether global surgi cal packages are appropriately valued. In its report on eye and ocular surgeries, “N ational Review of Evaluation and Management Services Included in Eye and Oc ular Adnexa Global Surgery F ees for Calendar Year 2005” (A05-07-00077), the OIG reviewed a sample of 300 eye and ocular surgeries, and counted the

actual number of face-to-face services recorded in the patients’ medical records to establish whether and, if so, how many post-operative E/M services were furnished by the surgeons. For about two-thirds of the claims sampled by the OIG, surgeons furnished fewer E/M services in the post-operative period than were included in th e global surgical package payment for each procedure. A small percentage of the surgeons furnished more E/ M services than were included in the global surgical package payment. The OI G identified the number of face-to-face services recorded in the medical record, but did not review the medical necessity of the surgeries or theCMS-1612-FC 134

related E/M services. The OIG c oncluded that the RVUs for thes e global surgical packages are too high because they include a higher number of E/M services than typically are furnished within the global period for th e reviewed procedures. Following that report, the OIG continued to investigate E/M services furnished during global surgical periods. In May 2012, the OIG published a repor t entitled “Musculoskeletal Global Surgery Fees Often Did Not Reflect the Nu mber of Evaluation and Management Services Provided” (A-05-09-00053). For this investigation, the OIG sa mpled 300 musculoskeletal global surgeries and again found that, for the majority of sampled surgeries, physicians furnished fewer E/M services than were included as part of th e global period payment for that service. Once again, a small percentage of surgeons furnished more E/M services than were included in the global surgical package payment. The OIG concluded that the RVUs for these global surgical packages are too high because they include a hi gher number of E/M services than typically are 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 studied global surgical paymen ts to reflect the number of E/M services that are actually being furnished. Ho wever, since it is not necessary under our current global surgery payment policy for a surgeon to report the indi vidual E/M services actua lly furnished during the global surgical period, we do not have objective data upon which to assess whether the RVUs for global period surgical services reflect the typical number or le vel of E/M services that are furnished. In the CY 2013 PFS proposed rule (77 FR 44738), we previously sought public comments on collecting these data. As summar ized in the CY 2013 PFS final rule (77 FR 68913) we did not discover a consensus among stakeholders regarding either the most appropriate means to gather the data, or the need for, or the appropriateness of using such data in valuing these services. In response to our co mment solicitation, some commenters urged us toCMS-1612-FC 135

accept the RUC survey data as accurate in spite of the OIG reports and other concerns that have been expressed regarding whether the visits included in the globa l periods reflected the typical case. Others suggested that we should conduct ne w surveys using the RUC approach or that we should mine hospital data to identify the typical number of visits furnis hed. Some comments suggested eliminating the 10- a nd 90-day global codes. (3) Limitations on Appropriate Future Valu ations of 10- and 90-day Global Codes Historically, our attempts to adjust RVUs for global services based on changes in the typical resource costs (especially with regard to site of servic e assumptions or changes to the number of post-surgery visits) ha ve been difficult and controversia l. At least in part, this is because the relationship between the work RVUs for the 10- and 90-day global codes (which includes the work RVU associated with the pr ocedure itself) and the number of included postoperative visits in the existing va lues is not always clear. So me services with global periods have been valued by adding the work RVU of th e surgical procedure and all pre- and postoperative E/M services included in the globa l period. However, in other cases, as many stakeholders have noted, the total work RVUs for surgical procedures and post-operative visits in global periods are estimated as a single value without any explicit corre lation to the time and intensity values for the indi vidual service components. A lthough we would welcome more objective information to improve our determination of the “typical” case, we believe that even if we engaged in the collection of better data on the number and le vel of E/M services typically furnished during the global periods for global surgery services, the valuation of individual codes with post-operative periods would not be straight forward. Furthermore, we believe it would be important to frequently update the data on the number and level of visi ts furnished during the post-operative periods in order to account for any changes in the patient population, medical practice, or business arrangements. Practitioners paid through the PFS do not report such data.CMS-1612-FC 136

(4) Unwarranted Payment Disparities Subsequent to our last comm ent solicitation regarding the valuation of the post-operative periods (77 FR 68911 through 68913), some stakehol ders have raised concerns that global surgery packages contribute to unwarranted pa yment disparities between practitioners who do

and do not furnish these services. These stakeholders have addressed severa l ways the 10- and 90-day global packages may contribute to unwarranted payment disparities. The stakeholders noted that, through the global surgery packages, Medicare pays practitioners who furnish E/M services during post-surgery periods rega rdless of whether the services are actually furnished, while practitioners who do not fu rnish global procedures with post-operative visits are only paid fo r E/M services that are actually furnished. In some cases, it is possible that the practitioner furnishing the global surgery procedure may not furnish any postoperative visits. Although we have policies to address the situation when post-operative care is transferred from one practitioner to another, the beneficiary mi ght simply choose to seek care from another practitioner without a formal transfer of care. Th e other practitioner would then bill Medicare separately for E/M services for which payment was included in the global payment to the original practitioner. Those services woul d not have been separately billable if furnished by the original practitioner. These circumstances can lead to unwarranted payment differences, allowing some practitioners to receive payment for fewer servic es than reflected in the Medicare payment. Practitioners who do not furnish global surgery serv ices bill and are paid only for each individual service furnished. When global surgery values are based on inaccurate assumptions about the typical services furnished in the post-operative periods, these pa yment disparities can contribute to differences in aggregate RVUs across special ties. Since the RVUs are intended to reflect

differences in the relative resource costs involved in furnishing a service, any disparity betweenCMS-1612-FC 137

assumed and actual costs results not only in paying some practitioners for some services that are not furnished, it also skews rela tivity between specialties. Stakeholders have also pointed out that payment disparities can arise because E/M services reflected in global peri ods generally include hi gher PE values than the same services when billed separately. The difference in PE valu es between separately billed visits and those included in global packages resu lt primarily from two factors th at are both inherent in the PFS pricing methodology. First, there is a different mix of PE inputs (clinical labor/s upplies/ equipment) included in the direct PE inputs for a global period E/M servi ce and a separately bill ed E/M service. For example, the clinical labor inputs for separate ly reportable E/M codes includes a staff blend listed as “RN/LPN/MTA” (L037D) and priced at $0.37 per minute. Instead of this input, some codes with post-operative visits include the sta ff type “RN” (L051A) priced at a higher rate of $0.51 per minute. For these codes, the higher re source cost may accurately reflect the typical

resource costs associated with t hose particular visits. However, the different direct PE inputs may drive unwarranted payment disparities amo ng specialties who report global surgery codes with post-operative periods and those that do no t. The only way to correct these potential discrepancies under the current system, which re sult from the specialty-based differences in resource costs, would be to include standard di rect PE inputs for these services regardless of whether or not the standard inputs are typical for the specialties furnishing the services. Second, the indirect PE allocated to the E/M visits included in global surgery codes is higher than that allocated to separately furnishe d E/M visits. This occu rs because the range of specialties furnishing a particul ar global service is generally not as broad as the range of specialties that report separate individual E/M services. Since the specialty mix for a service is a key factor in determining the allo cation of indirect PE to each c ode, a higher amount of indirectCMS-1612-FC 138

PE can be allocated to the E/M services that are va lued as part of the globa l surgery codes than to

the individual E/M codes. Practitioners who use E/M codes to report visits separately are paid

based on PE RVUs that reflect the amount of i ndirect PE allocated across a wide range of specialties, which has the tendency to lower the am ount of indirect PE. For practitioners who are paid for visits primarily through post-operative pe riods, indirect PE is generally allocated with greater specificity. Two significant steps would be required to alleviate the impact of this disparity. First, we would have to identify the exact mathematical relationship between the work RVU and the number and level of post-operative visits for each global code; and second, we would have to propose a significant alteration of th e PE methodology in order to allocate indirect

PE that does not correlate to the specialties reporting the code in the Medicare claims data. Furthermore, stakeholders have pointed out that the PE RVUs for codes with 10- or 90-day post-operative periods reflect the assumption that all outpatie nt visits occur in the higherpaid non-facility office setting, when many of thes e visits are likely to be furnished in providerbased departments, which would be paid at the lo wer, PFS facility rate if they were billable separately. As we note elsewher e in this final rule with comment period, we do not have data on the volume of physicians’ services furnished in provider-based depa rtments, but public information suggests that it is not insignificant and that it is grow ing. When these services are paid as part of a global packag e, there is no adjustment made based on the site of service. Therefore, even though the PFS payment for servi ces furnished in post-operative global periods might include clinical labor, disposable s upply, and medical equipment costs (and additional indirect PE allocation) that are incurred by th e facility and not the pr actitioner reporting the service, the RVUs for global code s reflect all of these costs as sociated with the visits. (5) Incompatibility of Current Packages with Curr ent Practice and Unreliability of RVUs for Use

in New Payment ModelsCMS-1612-FC 139

In addition to these issues, the 10- and 90-da y global periods reflect a long-established but no longer exclusive model of post-operative care that assumes the same practitioner who furnishes the procedure typically furnishes the fo llow-up visits related to that procedure. In many cases, we believe that models of post-ope rative care are increa singly heterogeneous, particularly given the overal l shift of patient care to larger prac tices or team-based environments.

We believe that RVUs used to establish PFS payments are likely to serve as critical building blocks to developing, testing, and im plementing a number of new payment models, including those that focus on bundled payments to pr actitioners or payments for episodes of care. Therefore, we believe it is crit ical for us to ensure that th e PFS RVUs accurately reflect the

resource costs for individual PFS services instead of reflecting potentially skewed assumptions regarding the number of se rvices furnished over a long period of time in the “typical” case. To the extent that the 10- and 90-day global pe riods reflect inaccurate assumptions regarding

resource costs associated with i ndividual PFS services, we believe they are likely to be obstacles to a wide range of potential improvements to PFS payments, including the potential incorporation of payment bundling designed to foster efficiency and quality care for Medicare

beneficiaries. c. Proposed Transformation of 10- and 90-day Global Packages into 0-day Global Packages Although we have marginally addressed some of the concerns noted above with global packages in previous rulemaki ng, we do not believe that we have made significant progress in addressing the fundamental issues with the 10- and 90-day post-operative global packages. In

the context of the misvalued code initiative, we believe it is critic al for the RVUs used to develop PFS payment rates reflect the most accurate reso urce costs associated with PFS services. Based on the issues discussed above, we do not believe we can effectively address the issues inherent in establishing values for the 10- and 90-day global packages unde r our existing methodologies andCMS-1612-FC 140

with available data. As such, we do not beli eve that maintaining the post-operative 10-and 90- day global periods is compatible with our continue d interest in using more objective data in the valuation of PFS services and accurately valuing services relative to each other. Because the typical number and level of post- operative visits duri ng global periods may vary greatly across Medicare practitioners and beneficiaries, we be lieve that continued valuation and payment of these face-to-face services as a multi-day packag e may skew relativity and create unwarranted payment disparities within PFS fee-for-service paym ent. We also believe that the resource based valuation of individual physicia ns’ services will continue to serve as a critical foundation for Medicare payment to physicians, whether thr ough the current PFS or in any number of new payment models. Therefore, we believe it is cr itical that the RVUs under the PFS be based as closely and accurately as possibl e on the actual resources invol ved in furnishing the typical occurrence of specific services. To address the issues discussed above, we proposed to retain globa l bundles for surgical services, but to refine bundles by transforming over several years all 10 - and 90-day global codes to 0-day global codes. Medica lly reasonable and necessary visits would be billed separately during the pre- and post-operative periods outside of the day of the surgical procedure. We propose to make this transition for current 10- day global codes in CY 2017 and for the current 90-day global codes in CY 2018, pending the availability of da ta on which to base updated values for the global codes. We believe that transforming all 10- and 90-day global codes to 0-day global codes

would:

• Increase the accuracy of PFS payment by se tting payment rates for individual services based more closely upon the typical resour ces used in furnishing the procedures;CMS-1612-FC 141

• Avoid potentially duplicativ e or unwarranted payments when a beneficiary receives post-operative care from a different pr actitioner during th e global period;

• Eliminate disparities between the payment for E/M services in global periods and those furnished individually;

• Maintain the same-day packaging of pre- and post-operative physic ians’ services in the 0-day global; and

• Facilitate availability of more accurate data for new payment models and quality

research. As we transition these codes, we would need to establish RVUs that reflect the change in the global period for all the codes currently valued as 10- and 90- day global surgery services. We sought assistance from stakeholders on various aspects of this task. Prior to implementing these changes, we intend to gather objectiv e data on the number of E/M and other services furnished during the current post-operative peri ods and use those data to inform both the valuation of particular servi ces and the overall bu dget neutrality adjustments required to implement this proposal. We sought comment on th e most efficient means of acquiring accurate data regarding the number of visi ts and other services actually being furnished by the practitioner during the current post-operative pe riods. For all the reasons stated above, we do not believe that survey data reflecting assumptions of the “typical case” meets the standards required to measure the resource costs of the wide range of services furnished during the post-operative periods. We acknowledge that collecting inform ation on these servic es through claims submission may be the best approach, and we would propose such a coll ection through future rulemaking. However, we

are also interested in alternatives. For example, we sought information on the extent to which individual practitioners or prac tices may currently maintain their own data on services furnished during the post-operative period, and how we might collect and obj ectively evaluate that data.CMS-1612-FC 142

We also sought comment on the best means to ensure that allowing separate payment of E/M visits during post-operative periods does not in centivize otherwise unne cessary office visits during post-operative periods. If we adopt this proposal, we intend to monitor any changes in the utilization of E/M visits following its implementa tion but we also solic ited comment on potential payment policies that will mitigate such a change in behavior. In developing this proposal, we considered several alternatives to the transformation of all global codes to 0-day global codes. First, we again considered the pos sibility of gathering data and using the data to revalue the 10- and 90- day global codes. While this option would have maintained the status quo in terms of repor ting services, it would have required much of the same effort as this proposal without alleviating many of the problems associated with the 10- and 90-day global periods. For example, collecting accurate data would allo w for more accurate

estimates of the number and kind of visits included in the post-operative periods at the time of the survey. However, this alternative appro ach would only mitigate part of the potential for unwarranted payment disparities. For example, the values for the visits in the global codes

would continue to include differe nt amounts of PE RVUs than se parately reportable visits and would continue to provide incentives to some practitioners to mini mize patient visits. Additionally, it would not address the changes in practice patt erns that we believe have been occurring whereby the physician furnishing the pr ocedure is not necessar ily the same physician providing the post-procedure follow up. This alternative option would also rest exte nsively on the effectiveness of using the new

data to revalue the codes accurate ly. Given the unclear relations hip between the assigned work RVUs and the post-operative visits across all of these services, incorporating objective data on the number of visits to adjust work RVUs would still necessitate extensiv e review of individual codes or families of codes by CMS and stakeholders, including the RUC. We believe theCMS-1612-FC 143

investment of resources for such an effort woul d be better made to so lve a broader range of problems. We also considered other possibilities, such as altering our PE methodology to ensure that the PE inputs and indirect PE for visits in the global period were valued the same as separately reportable E/M codes or requiring reporting of the visi ts for all 10- and 90-day global services while maintaining the 10- and 90-day global period payment rates. However, we believe this option would require all of the same effort by practitioners, CMS, and other stakeholders without alleviating most of the problems addressed in the preceding paragraphs. We also considered maintaining the status quo and identifying each of the 10- and 90-day global codes as potentially misval ued through our potentially misval ued code process for review as 10- and 90-day globals. Inappropriate valuatio ns of these services has a major effect on the fee schedule due to the percentage of PFS dollars paid through 10- and 90-day global codes (3 percent and 11 percent, respectiv ely), and thus, valuing them a ppropriately is critical to appropriate valuation and re lativity throughout the PFS. Through the individual review approach, we could review the appropriateness of the global period and the accurate number of visits for each service. Yet revaluing all 3,000 global surgery codes through the potentially misvalued codes approach would not address many of the problems identified above. Unless such an effort was combined with change s in the PE methodology, it would only partially address the valuation and accuracy issues and would leave all the other issues unresolved. Moreover, the valuation and accuracy issues th at could be addressed through this approach would rapidly be out of date as medical practi ce continues to change. Therefore, such an approach would be only partially effective a nd would impede our ability to address other potentially misvalued codes.CMS-1612-FC 144

We sought stakeholder input on an accurate a nd efficient means to revalue or adjust the work RVUs for the current 10- and 90-day global codes to reflect the typical resources involved in furnishing the services including both the pre- and post-operative care on the day of the procedure. We believe that collecting data on the number and level of post-operative visits furnished by the practitioner reporting current 10-and 90-day global codes will be important to ensuring work RVU relativity across these services. We also believe that these data will be important to determine the relationship between current work RVUs and current number of postoperative visits, within categories of codes and c ode families. However, we believe that once we collect those data, there is a wide range of possi ble approaches to the re valuation of the large number of individual global services, some of which may deviate from current processes like those undertaken by the RUC. To date, the pote ntially misvalued code initiative has focused on several hundred, generally high-volume codes per year . This proposal requir es revaluing a larger number of codes over a shorter period of time and includes many services with relatively low volume in the Medicare population. Given these circumstances, it does not seem practical to survey time and intensity information on each of these procedures. Absent any new survey data regarding the procedures themselves, we believe that data regarding th e number and level of post-service office visits can be used in conjunc tion with other methods of valuation, such as:

• Using the current potentially misvalued code process to identify and value the relatively small number of codes that represent th e majority of the volume of services that are currently reported with codes w ith post-operative periods, and then adjusting the aggregate

RVUs to account for the number of visits and us ing magnitude estimation to value the remaining services in the family.

• Valuing one code within a family through the current valuation process and then using magnitude estimation to value the remaining services in the family.CMS-1612-FC 145

• Surveying a sample of codes across all pro cedures to create an inde x that could be used to value the remaining codes. Although we believe these are plausible options for the revaluation of these services, we believed there may be others. Therefore, we soug ht input on the best approach to achieve this proposed transition from 10- and 90-day, to 0-da y global periods, including the timing of the changes, the means for revaluation, and the most effective and least burde nsome means to collect objective, representative data re garding the actual numb er of visits currently furnished in the post-operative global periods. We also solicited comment on whether the effective date for the transition to 0-day global periods should be staggered across families of codes or other categories. For example, while we proposed to transition 10-day globa l periods in 2017 and 90-day global periods in 2018, we solicited comment on whether we should consider implementing the transition more or less quickly and over one or several years. We also solicited comment regarding the ap propriate valuation of new, re vised, or potentially misvalued 10- or 90-day global codes before im plementation of this proposal. We received many comments regarding the propos ed transition to 0-day global packages. Many commenters expressed support or opposition to the proposal. Some commenters offered direct responses to the topics for which we spec ifically sought comment, while others raised questions regarding how the transition would be implemented. In the following paragraphs, we summarize and respond to these comments. Comment: Several commenters supporte d the proposal, including commenters representing several medical specialty societie s and several health sy stems. Many of these commenters agreed with the reasons presented in the proposal. These commenters agreed that the current structure of the global surgery co des prevents CMS from accurately valuing and paying for these services, even if CMS had nece ssary visit data available. Many commentersCMS-1612-FC 146

agreed that the current arrangement may lead to unwarranted payment di sparities and that the current packages have not evolved with changes in practice and because of this, likely provide unreliable building blocks fo r new payment methodologies. In agreeing with the proposal, MedPAC stated that it “is essential that the individual services that make up a bundle have accurate values and that there is a mechanism to ensure that the services that are part of the bundle are not paid separate ly (unbundling). Otherwise, the payment rate for the entire bundle will be inaccura te.” MedPAC urged CMS to finalize this proposal and plan to use the more accurate valu ations to create more accurate bundles in the

future. Response: We appreciate the commenters’ s upport for the proposal, and agree that there are many reasons why the current construction of the global surgery packages is difficult to

reconcile with accurate valuation of individual services within th e current payment construct of the PFS. We agree that achieving the agency’s goal of greater bund ling requires accurate valuation of component services in a surgical procedure. Comment: Some commenters, in cluding several of those repr esenting specialty societies, urged CMS to postpone finalizati on of the proposal pending the re port of stakeholder efforts to conduct a comprehensive analysis of the effect it would have on the provision of surgical care, surgical patients, and the surgeons who care for them. Response: We share stakeholders’ concerns regarding the potential im pact of the change

on Medicare beneficiaries and practitioners. However, ba sed upon our analysis and the information that stakeholders have provided, we believe delaying the proposal to further study the problems is not warranted given the signific ant concerns that have been raised with the current construction of the global surgery packages . Instead, as we articulated in making the proposal, we anticipate that furthe r analysis by stakeholders will contribute to implementing theCMS-1612-FC 147

transition in a manner that accurately values and pays for PFS services. We believe that accurate

valuation of services furnished to Medicare bene ficiaries is overwhelmingly in the best interest

of both beneficiaries and those who care for them.

Comment: We received several comments from commenters who opposed our proposal, and in general these commenters shared the concer ns of those who urged a delay in finalizing or implementing the proposal. In addition, some commenters who opposed th e proposal disputed our contention that the global peri ods contribute to unwarranted pa yment disparities, saying that

the increased direct and indir ect PE and MP RVUs for E/M se rvices furnished in the global surgical post-operative periods accurately acc ount for the increased PE and MP costs of practitioners who furnish these serv ices relative to practitioners who typically furnish separately reportable E/M services. Response: Just as we do not agree that we should delay addressing significant problems with valuations while we further study the issues , we do not believe these same issues raised by commenters opposing the proposal ar e impediments to implementation. The issues relating to valuation of global period E/M services usi ng our PE methodology are just one of several important considerations that led us to propose transforming 10- and 90-da y global services to 0- day global packages. We continue to believe the proposed transformation to 0-day global packages is a simple and immediate step to improve the valuation of the various services included in surgical care. However, Medica re remains committed to bundled payment as a mechanism for delivery system reform and we w ill continue to explore the best way to bundle surgical services, includi ng alternatives to the 0-da y global surgical bundle. Comment: Many commenters who opposed th e proposal addressed valuation problems that would exist if the proposal were implemented. Some stated that, were CMS to finalize the proposal to pay for post-surgical E/Ms using th e same codes, the PE and MP RVUs for theCMS-1612-FC 148

services would be artificially reduced because the data from other specialties would be incorporated. These commenters suggested CMS should consider how to maintain the current differences in payment for these services even if the proposal were finali zed. Some commenters suggested that CMS would need to account for the additional practice expense and malpractice costs for post-operative surgical visits. Response: We develop and establish work, PE, and MP RVUs for specific services to

reflect the relative resource cost s involved in furnishing the typical PFS service. In developing the proposal, we noted that by including a signif icant number of E/Ms in the global periods for surgical services, the PFS ratese tting methodology disti nguishes these services from other E/Ms for purposes of developing PE and MP RVUs, pot entially to the advantage of particular specialties with higher PE and MP RVUs. In contrast, the work RVUs for individual, separately billed E/M services furnished, for example, by primary care practitione rs are valued more generally as individual services , and values are not maintained separately from the work RVUs for E/Ms furnished by other practitioners. Ther efore, we do not agree with commenters that Medicare should establish higher PE and MP valu es for E/M services furnished in the postsurgical period than for other E/M services. Comment: Several commenters suggested th at CMS should not use the OIG reports to generalize its concerns about the provision of surgical care, b ecause the OIG reports represent only a small sample of observations of specific procedures and specialties. Other commenters suggested that the OIG methodology might be flawed because, since CMS does not require documentation of post-operative visits, many practi tioners may not document such visits in the

medical record. Response: We do not have any reason to believe that the OIG findings on the global surgical service packages furnis hed by particular specialties that the OIG reviewed are notCMS-1612-FC 149

generalizable to other global su rgery services. Nor did the co mmenters provide any evidence that the OIG conclusions are likely to be less accurate than the survey estimates that CMS uses to value the services. Finally, having an incorrect nu mber of postoperative visi ts is only one of the many valuation problems that have been identified for global surgical packages. Additionally, we find the suggestion that physicians do not docu ment medical visits th at are occurring in the post-surgical period to be concerning. As a general matter, Medica re does not require documentation to support a billed service beyond in formation that the physician would normally maintain in the patient’s medical record. Even in the absence of billing Medicare or another insurer, we believe that physicians and other pr actitioners following st andard medical practice would document what occurred during a patient encounter in order to ensure the patient’s medical history is accurate and up- to-date, and to facilitate con tinuity in the patient’s medical

care. Comment: One commenter asserted that the 90-day global period was created to prevent two behaviors referred to as “fee-splitting” and “itinerant surgery.” According to the commenter, these terms refer to the practice wher e a surgeon would provide only the surgery and leave postoperative care to ot her practitioners. The commenter believes these practices are inconsistent with professional standards, and that it is medically necessary and expected by patients that surgeons will evaluate their patient s on a daily basis in the hospital and as needed on an outpatient basis during the recovery period. Response: We do not believe th at the global surgical package was designed to ensure or allocate appropriate post-operative care among practitioners. Under Me dicare’s current global surgery policy, practitio ners can agree on the transfer of care during the global period and, in such cases, modifiers are used in order to spli t the payment between the procedure and the postoperative care. We do not agree that global surg ical packages obligate the surgeon to furnishCMS-1612-FC 150

some or all of the post-operative care. Global su rgical packages are valued based on the typical service, and we would not expect every surgery to require the same number of follow-up visits. However, we would expect that over a large number of services, the central tendency would reflect the number of visits we included as ty pical for purposes of valuing the global package; and as discussed above, we have not found that this is ne cessarily the case. . Even if Medicare maintains the 10- and 90-day gl obal surgery packages, there w ould be no assurance that the surgeon, and not another practiti oner, would furnish all or a certain amount of post-operative care (whether by the patient’s choi ce of practitioner or otherwis e). The global payment includes payment for post-operative care with the payment for the surgery, which makes it difficult to know whether or by whom the post-operative care was actually furnished unless there is an

official transfer of care. We are confident that the surgical community will continue to furnish appropriate care for Medicare bene ficiaries irrespective of change s in the structure of payment for surgical services.

Comment: Several commenters stated that ifMedicare adopts a policy to pay for postoperative care using E/M codes rather than thro ugh a global package, Medicare will likely pay a higher level of E/M visits when they are separately billed than it does currently, as the existing global packages tend to include more lower leve l E/M services than t hose that are generally reported. Response: We acknowledge that the visits assumed in the global packages are generally

valued as lower-level visits than are most commonly furnished, as reflected in Medicare utilization data for separately reportable E/Ms. However, this disparity is only pertinent to the proposal if the global packages are inaccurate ly valued or, if, under the proposed policy, practitioners who furnish these serv ices are likely to inaccurately report the level of E/M service that is actually being furnished. If the former is true, then we believe this supports the proposal toCMS-1612-FC 151

revalue these services. As with every service, we expect physician s to bill the most appropriate

E/M codes that reflect the care that is furnished, including for post-operative care. Comment: One commenter expressed concern that the proposal to require separate billing for postoperative surgical care provides a basis for the even tual denial of payment to one or more of the postoperative care providers, ba sed on the notion that care furnished by other specialties is duplicative of or replaces care furnished by the surgeon. This commenter stated that multiple providers with differing expertise and training are essential to achieve optimal patient outcomes and expressed concern that this proposal will provide disincentives to optimal patient care. Response: As we stated in the proposal, we believe that there ar e various models for postoperative care that can often include multiple providers, and this is another important reason why we believe the services with longer global pe riods should be transformed to 0-day packages to accommodate heterogeneous models of car e that optimize patient outcomes.

Comment: One commenter recommended that CM S establish G-codes for three levels of post-operative visits furnished by the original su rgeon or another surgeon with the same board certification, as well as a second set of three level G-codes for postoperative visits furnished by another provider. The commenter also suggested that CMS should develop methods to fairly measure the duration of E/M times through which a large sample of surgeons might report the number and intensity of post-operative visits . The commenter also recommended that CMS

track E/M services furnished to surgical patients w ithin the global period by a physician other than the operating surgeon, for the same or sim ilar diagnosis, in order to begin to understand what portion of postoperative visits are being billed outside of the global period.

The RUC informed CMS that it has identi fied several large ho spital-based physician group practices that internally use CPT code 99024 to report each bundled post-operative visit,CMS-1612-FC 152

and therefore data is already being captured for some Medi care providers. The RUC also suggested that CMS may have denied-claim s data available for CPT code 99024 via the Medicare claims processing system. The RUC r ecommends that CMS work with it to explore the availability, usefulness, a nd appropriateness of these data from group practices and the CMS denied-claims dataset, in order to gather existi ng, objective data to valid ate the actual number of post-operative visits for 10-day and 90-day proc edures. The RUC also suggested that CMS should consider reviewing Medica re Part A claims data to de termine the length of stay for surgical services furnished in the i npatient acute care hospital setting.

MedPAC stated that data co llection could take several y ears, would be burdensome for CMS and providers, and may be inaccurate since pr oviders would have little incentive to report each visit. Furthermore, MedPAC suggested th at such data collection would be unnecessary since the current ratesetting methodology already assumes partic ular numbers of visits. MedPAC suggested that CMS should reduce the R VUs for the 10- and 90 -day global services based on the same assumptions currently used to pay for these services. Several other commenters agreed with the approach advocated by MedPAC (often referred to as “reverse-building block”) to revalu ing the services. These commenters stated that

since CMS has increased RVUs for these services proportionate to the number of E/M services assumed to be included in the pos toperative period, for the sake of relativity, the RVUs attributed to the visits can be fairly removed in order to value the new 0-day global codes. Many of these commenters acknowledged that this approach would result in nega tive or other anomalous values for many of these codes, but a sserted that codes with anomalous values might then be individually reviewed. MedPAC suggested that if specialty so cieties or the RUC believe that the new values for specific global codes are inac curate, they could present evidence that the codes are misvalued to CMS, presumably th rough the potentially misvalued code publicCMS-1612-FC 153

nomination process. MedPAC fu rther states that for codes without accurate post-operative assumptions, CMS could calculate interim RVUs for these codes based on the average percent reduction for other global codes in the same family. Many other commenters were agai nst the reverse-building block approach to revaluation. These commenters stated that backing out the bundled E/M servic es would be highly inappropriate and methodologically unsound since the services were not nece ssarily valued using a building-block methodology. Many of these comme nters, including the RU C, stated that the amount of post-operative work included in the codes can only be appropria tely surveyed, vetted, and valued by the RUC. Response: We appreciate the concerns of commenters regarding the difficulty of revaluing the global surgery code s as 0-day global packages. As we stated in making the proposal, we believe that such stakeholder input and participation in any revaluation will be critical to the accuracy of the re sulting values. We will consider all of these comments as we

consider mechanisms for revaluations and as we propose new values for specific services. We believe that the challenges involved in revalu ation, such as those articulated by commenters, reinforce our understanding that the current construction of the 10- and 90-day global packages are not a sustainable, long-term approach to the a ccurate valuation of surg ical care. . As noted above, we will continue to explore appropriate ways of bundling global surgical services. Comment: In general, commenters s upporting the proposal al so supported CMS’s proposed timeframe to transition 10-day global codes and 90-day global codes to 0-day global surgical packages by 2017 and 2018, respectively. In contrast, most commen ters objecting to, or articulating reservations about, the proposal urged CMS to slow its implementation. Some of these commenters suggested that th e process used to establish th e current values for these CPTCMS-1612-FC 154

codes is ideal and stated that it would take many years to va lue the many individual services using the same methodologies.

The RUC stated that there ar e over 4,200 services within th e PFS with a 10-day or 90-day global period, so the scope of the proposal is very large and the transi tion should be staggered over many years. However, the RUC also pointed out that most of these services have relatively low utilization, as only 268 of them (or 6 percen t of 10- or 90-day global surgery services) were performed more than 10,000 times annually based on 2013 Medicare claims data. Response: We appreciate the concerns of the commenters. We agree with those commenters who urged us to move quickly to valu e services as accurately as possible. We note that most comments suggesting a delay in reva luation were based on a common underlying view

that code-level review of the full set of servi ces by the RUC based on pr actitioner surveys is the only appropriate way to value the services. As we stated in making the proposal, we do not believe that surveying practitioners who furnish each of these services is a practical or necessarily advisable a pproach to appropriate valuation. Regardless of when the proposal is implemented, it seems likely that the number of codes to be revalued is much larger than the number of codes that should or can be surveyed. Through its normal process, the RUC routinel y makes annual recomm endations regarding several hundred codes, and we ac knowledge that thousands of serv ices cannot be valued using the typical RUC process in one year. On the ot her hand we believe that there are other options for revaluing some of the global surgery codes as 0-day global p ackages, particularly those of low volume, and we have indicated a willingness to work with the RUC to determine appropriate mechanisms for revaluations. Therefore, although we agree that revaluing such a high number of codes is a significant undertaking, we do not believe that that the required revaluations would represent an undue burden between the present and the pr oposed implementation dates. We alsoCMS-1612-FC 155

note that in order to focus efforts on revaluing the global surgery packages, we are not asking the RUC to review the nearly 100 services we propo sed as potentially misval ued this year under the high expenditure screen. We continue to remain interested in other pote ntial data sources for accurately valuing PFS services, especially the va st majority of 10- and 90-day global codes for which there is not significant volume. We also urge stakeholders to engage with us to help us understand why alternative approach es to the revaluation of the 10- and 90-day global services would require the kind of delay that was urge d based on the assumption that the RUC survey approach would be used for all those services. Additionally, we request stakeh olders, including the CPT Editorial Panel and the RUC, to consider the utility of establishing and mainta ining separate coding a nd national Medicare RVUs for the many procedures that have little to no utilization in the Me dicare population. For example, there are over 1,000 10- and 90-day glob al codes with fewer than 100 annual services in the Medicare database. Although we recognize that some portion of these services may be utilized more extensively by non-Me dicare payers, it is also likely that many of these codes may reasonably be consolidated. We request that appropriate coding for surgical services be considered as part of revaluing global surgery. Comment: Many commenters expr essed concerns that requiri ng beneficiary coinsurance for each follow-up visit could dissuade beneficiar ies from returning for necessary follow-up care and, therefore, adversely affect surgical outcomes. Many of these commenters acknowledged that overall patient liability for the total amount of care could be reduced, depending on revaluation, but stated that payi ng separate coinsurance for follo w-up care can cause patients to perceive the net payments as larger, give n the frequency of payment required. These commenters stated that the magnitude of these problems might be directly proportionate to how sick the patient is.CMS-1612-FC 156

Response: We understand the concerns of the commenters, but do not agree that

Medicare beneficiaries are unlik ely to appreciate the differenc e between frequency of payment and overall financial liability. We also note that the significant majority of patient encounters with Medicare practitioners generate some degr ee of beneficiary liabilit y. While liability could prompt the proportion of benefi ciaries without secondary in surance to forgo medically reasonable and necessary care for the treatment of illness or injury, we have no reason to

conclude that this would be the case specifically for post-op erative care. We do acknowledge that surgeons may need to explain the importan ce of follow-up care so that patients understand and appreciate how compliance with follow-up care can improve the overall quality of care and outcomes. As noted above, while our proposal is to move to 0-day global packages as a simple, immediate adjustment, the agency remains committed to bundling as a key component of payment system delivery reform, and we will consider beneficiary impact as we further consider the appropriate size and constr uction of a surgical bundle. Comment: Several commenters expressed co ncerns that the proposal would result in disjointed or inadequate care an d/or disrupt surgical registry data. Thes e commenters suggested that neither patients nor alternate providers ar e as qualified to determine whether or not a postoperative visit by the surgeon is necessary. Response: As discussed above, we do not agree that patients who require the postoperative care of a surgeon are likely to for go such care if Medicare changes how we pay the surgeon for furnishing that care. Although several commenters expressed these and similar kinds of concerns, none explained how the proposed ch ange in payment would change post operative care. We continue to believe that surgeons will continue to furnish appropriate post operative care to Medicare beneficiaries, and we do not agree that concerns about increased patient liability or disjointed care are warranted.CMS-1612-FC 157

Comment: Several commenters expresse d concerns over other Medicare payment policies related to surgical procedures. Some commenters stated that the current multiple procedure payment reduction policie s that apply to all 0-, 10-, and 90-day global codes are only appropriate for 10-day and 90-day globals due to the overlap in resource costs during the postoperative period. Othe r commenters noted that potential reductions in payment to surgeons to account for the reduced post-operative period would negatively impact practi tioners who assist at surgery despite the fact that their professional work and responsibilities have not changed. Response: We appreciate the issues raised by these commenters. Again, we seek continued input from the stakeholder community rega rding these and other issues that need to be considered in order to implement the transition. In the case of the MPPR, we note there are several hundred 0-day global code s where these payment policies currently apply. We are especially interested in understanding why stak eholders do not believe the policies effective for the current 0-day global codes would not similarl y be appropriate for the current 10-and 90-day codes that will be revalued as 0-day global codes. Comment: Many of the commenters who oppos ed or expressed concern about the proposal urged CMS to consider the extent to which this proposal would increase the administrative burden on CMS, MACs, and pr oviders. Other commenters urged CMS to consider that post-operative vis its would be subject to the same documentation requirements and other scrutiny as other separa tely-reportable PFS services. One commenter representing other payers opposed the proposal due to concerns about predicting the usage of post-operative

services. Response: We considered the administrati ve burden on both CMS and practitioners who

furnish these services in maki ng the proposal. In both cases, we note the administrative burden would be no greater than the burde n associated with the vast majo rity of other services paidCMS-1612-FC 158

through the Medicare PFS. We do not believe th at the burden of sepa rately reporting postoperative follow-up visits is part icularly or unduly burdensome, give n that most office visits paid through the PFS are separately repor ted under current Medicare polic ies. In comparison to the number of separately reported visi ts and other PFS services, the number of visits that likely occur in post-operative periods is relatively small. We do not agree that there ar e inherent reasons that medically necessary post-operative visits shoul d be exempt from the same documentation and other requirements applicable to other PFS services . We appreciate that changes in Medicare policy may affect other insurers who choose to ba se their payments on the PFS; however, it is our obligation to set our policies based upon the needs of Medicare and its beneficiaries. Comment: A few commenters urged CMS to cons ider the possibility that there could be confusion among practitioners and payers if some pa yers continue to base payment on the 10- or 90-day post-operative periods. Response: We believe that payment policie s that are appropriate for Medicare may not always be optimal for all payers. However, we seek continued input and analysis from other payers as we engage stakeholde rs in developing our implementati on strategy for the transition of 10- and 90-day global services to 0-day global services. Comment: Several commenters urged CMS to c onsult with stakeholders as we develop appropriate plans for the global period tran sition. These commenters cautioned that the structural reorganization of these services is chal lenging due to the large set of services that will be impacted and could potentially disrupt well -established payment for certain providers. Response: We appreciate thes e recommendations and agree that we should continue to consult with stakeholders regarding the implementation of this proposal.

After consideration of all the comments received regarding this proposal, we are finalizing the proposal to transiti on and revalue all 10- and 90-day global surgery services withCMS-1612-FC 159

0-day global periods, beginning w ith the 10-day global services in CY 2017 and following with the 90-day global services in CY 2018. We note that as we develop implementation details, including revaluations, we will take into consider ation all of the comments we received to our global surgery proposal. We will provide additio nal details during the CY 2016 rulemaking. We are finalizing a transformation to 0-day global codes because we believe this is the most straightforward way to improve the accuracy of valuation for the various components of global surgical packages, including pre- and post-opera tive visits and performance of the surgical procedure. However, we remain committed to delivery system reform and ensuring Medicare makes appropriate payment for bundles of services whether our payment covers a period of 0, 10 or 90 days. As we begin revalu ation of services as 0-day gl obals, we will actively assess

whether there is a be tter construction of a bundled paym ent for surgical services. We also actively seek the analysis and perspe ctive of all affected stakeholders regarding

the best means to revalue these services as 0-da y global codes. We urge all stakeholders to engage with us regarding potential means of ma king the transition as seamless as possible, both for patient care and provider impact. We are considering a wide range of approaches to all details of implementation from revaluation to communication and transition, and we are hopeful that sufficient agreement can be reached among stakeholders on important issues such as revaluation of the global servic es and appropriate coding for post-operative care. We remain committed to collecting objective data regarding th e number of visits typically furnished during post-operative periods and will explore the extant source options presented by commenters as we consider other options as well. 5. Valuing Services That Include Moderate Sedation as an Inhe rent Part of Furnishing the

ProcedureCMS-1612-FC 160

The CPT manual includes more than 300 diagnostic and therapeutic procedures, listed in Appendix G, for which CPT has determined that moderate sedation is an inherent part of furnishing the procedure and, therefore, only the single procedure code is appropriately reported when furnishing the service and the moderate seda tion. The work of moderate sedation has been included in the work RVUs for these diagnosti c and therapeutic proce dures based upon their inclusion in Appendix G. Simila rly, the direct PE inputs for thes e services include those inputs associated with furnishing a typical moderate sedation service. To the extent that moderate sedation is typically furnished as part of the di agnostic or therapeutic se rvice, the inclusion of

moderate sedation in the valuation of the procedure is appropriate. In the CY 2014 PFS proposed rule (79 FR 40349), we noted that it appe ared that practice patterns for endoscopic procedures were changing, with anesthesia increasingly being separately reported for these procedures. Fo r example, one study showed that while the use of a separate anesthesia professional for colonoscopies and upper endoscopies was just 13.5 percent in 2003, the rate more than doubled to 30.2 percent in 2009. An analysis of Medicare claims data showed that a similar pattern is occurr ing in the Medicare program. We found that, for certain types of procedures such as digestive su rgical procedures, a separate anesthesia service is furnished 53 percent of the time. For some of these digestive surgical procedur es, the claims analysis showed that this rate was as high as 80 percent. Our data clearly indicated that moderate sedation was no longer typical for all of the procedures listed in CPT’s Appendi x G, and, in fact, the data sugge sted that the percent of cases in which it is used is declining. For many of these procedures in Appendix G, moderate sedation continued to be furnished. The trend away from the use of modera te sedation toward a separately billed anesthesia serv ice was not universal. We found that it differed by the class of procedures, sometimes at the procedure code leve l, and continued to evolve over time. Due toCMS-1612-FC 161

the changing nature of medical practice in th is area, we noted that we were considering establishing a uniform approach to valuation fo r all Appendix G services for which moderate sedation is no longer inherent, rather than addressing this i ssue at the procedure level as individual procedures are revalued. We sought public comment on approaches to ad dress the appropriate valuation of these services. Specifically, we were interested in a pproaches to valuing Appendix G codes that would allow Medicare to pay accurately for moderate sedation when it is furnished while avoiding potential duplicative payments when separate anesthesia is furnis hed and billed. To the extent that Appendix G procedure valu es are adjusted to no longer in clude moderate sedation, we requested suggestions as to how moderate seda tion should be reported and valued, and how to remove from existing valuations the RVUs and inputs related to moderate sedation.

We noted that in the CY 2014 PFS final rule with comment period, we established values for many upper gastrointestinal procedures, 58 of which were included in Appendix G. For those interim final values, we included the inputs related to moderate sedation. We stated that we did not expect to change ex isting policies for valuing moderate sedation as inherent in these procedures until we have the oppor tunity to assess and respond to the comments on the proposed

rule on the overall valuati on of Appendix G codes. We received many helpful suggestions in response to our comment solicitation. At this time, we are not making any changes to how we value Appendix G codes for which moderate sedation is an inherent pa rt of the procedure. We intend to address this topic in future notice and comment rulemaking, taking into account the comments we received. In section II.G.

of this CY 2015 PFS final rule with comment period, we address inte rim final values and establish CY 2015 inputs for the lowe r gastrointestinal procedures, many of which are also listed in Appendix G.CMS-1612-FC 162

C. Malpractice Relative Value Units (RVUs)

1. Overview Section 1848(c) of the Act requires that e ach service paid under the PFS be comprised of three components: work; PE; and malprac tice (MP) expense. As required by section 1848(c) of the Act, beginning in CY 2000, MP R VUs are resource based. Malpractice RVUs for new codes after 1991 were extrapolated from si milar existing codes or as a percentage of the corresponding work RVU. Secti on 1848(c)(2)(B)(i) of th e Act also requires that we review, and if necessary adjust, RVUs no less often than every 5 years. For CY 2015, we are proposing to implement the third comprehensive review a nd update of MP RVUs. For details about prior updates, see the CY 2010 final rule with comment period (74 FR 33537). 2. Methodology for the Proposed Revision of Resource-Based Malpractice RVUs The proposed MP RVUs were calculated by a CMS contractor based on updated MP premium data obtained from state insurance rate filings. The methodology used in calculating the proposed CY 2015 review and update of res ource-based MP RVUs largely paralleled the process used in the CY 2010 update. The calcu lation required using information on specialtyspecific MP premiums linked to a specific servic e based upon the relative risk factors of the various specialties that furnish a particular service. Because MP premiums vary by state and specialty, the MP premium information were weighted geographically and by specialty. Accordingly, the proposed MP RVUs were ba sed upon three data sources: CY 2011 and CY 2012 MP premium data; CY 2013 Medicare pa yment and utilization data; and CY 2015 proposed work RVUs and geographic practice cost indices (GPCIs). Similar to the previous update, we ca lculated the proposed MP RVUs using specialty-specific MP premium data because th ey represent the actual expense incurred by practitioners to obtain MP insu rance. We obtained and used MP premium data from stateCMS-1612-FC 163

departments of insurance rate filings, primarily for physicians and surgeons. When the state insurance departments did not provide data, we used state rate filing data from the Perr and Knight database, which derives it s data from state insurance departments. We used information obtained from MP insurance rate filings with effective dates in 2011 a nd 2012. These were the most current data available during our data collecti on process. We collected MP insurance premium data from all 50 States, the District of Columbia, and Puerto Rico. Rate filings were not available in American Samoa, Guam, or the Virgin Islands. Premiums were for $1 million/$3 m illion, mature, claims-made policies (policies covering claims made, rather than those covering services furnis hed, during the policy term). A $1 million/$3 million liability limit policy means th at the most that would be paid on any claim is $1 million and the most that the policy would pay for claims over the timeframe of the policy is $3 million. We made adjustments to the prem ium data to reflect mandatory surcharges for patient compensation funds (funds to pay for any claim beyond the statutory amount, thereby limiting an individual physicia n’s liability in cases of a large suit) in states where participation in such funds is mandatory. We attempted to collect premium data representi ng at least 50 percent of the medical MP premiums paid. We included premium information for all phys ician and NPP specialties, and all risk

classifications available in the collected rate filings. Most insurance companies provided crosswalks from insurance service office (ISO) c odes to named specialties. We matched these crosswalks to Medicare primary specialty desi gnations (specialty co des). We also used information we obtained regarding surgical and nonsurgical classes. Some companies provided additional surgical subclasses; for example, distinguishing family practice physicians who

furnish obstetric services from those who do not.CMS-1612-FC 164

Although we collected premium data from all st ates and the District of Columbia, not all specialties had premium data in the rate fi lings from all states. Additionally, for some specialties, MP premiums were not available from the rate filings in any state. Therefore, for specialties for which there was not premium data for at least 35 states, and specialties for which there was not distinct premium data in the rate filings, we crosswalked the specialty to a similar specialty, conceptually or by available premiu m data, for which we did have sufficient and reliable data. Additionally, we crosswalked three specialties

− physician assistant, registered dietitian and optometry

− for which we had data from at least 35 states to a similar specialty type

because the available data contained such extr eme variations in premium amounts that we found it to be unreliable. The range in premium am ounts for registered dietitians is $85 to $20,813 (24,259 percent), for physician assistants is $614 to $35,404 (5,665 percent), and for optometry is $189 to $10,798 (5,614 percent). We crossw alked these specialties to allergy and immunology, the specialty with th e lowest premiums for which we had sufficient and reliable

data. Our proposed methodology for updating the MP RVUs conceptually followed the specialty-weighted approach, us ed in the CY 2010 update. The specialty-weighted approach bases the MP RVUs for a given service upon a we ighted average of the risk factors of all specialties furnishing the service. This approach ensures that all specialties furnishing a given

service are accounted for in the calculation of th e MP RVUs. We also continued to use the risk factor of the dominant specialty for rarely bi lled services (that is, when CY 2013 claims data reflected allowed services of less than 100). We proposed minor refinements for updating th e CY 2015 MP RVUs as compared to the previous update. These refinements included cal culating a combined national average surgical premium and risk factor for neurosurgery and neurology and updating the list of invasiveCMS-1612-FC 165

cardiology service HCPCS codes (for example, car diac catheterization a nd angioplasty) to be classified as surgery for purpos es of assigning service level ri sk factors. Additionally, we proposed to classify injection procedures used in conjunction with cardi ac catheterization as surgery (for purposes of assigning a service specific risk factor). To calculate the risk factor for TC services we proposed to use the mean um brella non-physician MP premiums obtained from Radiology Business Management Association (RBMA) survey data, used for the previous MP RVU update in 2010, and adjusted the premium da ta to reflect the change in non-surgical premiums for all specialties si nce the previous MP RVU update. As discussed in the CY 2015 proposed ru le (79 FR 40354 through 40355), we did not include an adjustment under the anesthesia fee schedule to reflect updated MP premium information and stated that we intend to propos e an anesthesia adjustment for MP in the CY 2016 PFS proposed rule. We also requested co mments on how to reflect updated MP premium amounts under the anesthesiology fee schedule. We posted our contractors report, “Report on the CY 2105 Update of Malpractice RVUs” on the CMS website. The report on MP RVUs fo r the CY 2015 proposed rule and the proposed MP premium amounts and specialty risk factors are accessible from the CMS website under the supporting documents section of th e CY 2015 PFS proposed rule at http://www.cms.gov/PhysicianFeeSched/ . A more detailed explan ation of our proposed MP RVU update can be found in the CY 2015 PFS proposed rule (79 FR 40349 through 40355). 3. Response to Public Comments We received over 70 industry comments on the CY 2015 proposed MP RVU update. A summary of the comments we received on the proposed MP RVU update and our responses are

discussed below.CMS-1612-FC 166

Comment: Two commenters supported our pr oposal to combine the surgical premium data for neurosurgery and neurology for establishi ng the surgical risk factor for neurosurgery. Response: We agree with the commenters a nd will finalize our appr oach for determining the surgical premium for neurosurgery as propos ed. We will combine su rgical premiums for neurology and neurosurgery to calc ulate a national average surgical premium and risk factor for

neurosurgery. Comment: Three commenters requested that we phase in the reduction for ophthalmology and optometry services over 2 years. The commenters stated that the reduction is due in part to an error we made in calcula ting the MP RVUs for ophthalmology and optometry codes under the previous MP RVU update in CY 2010. The commenters stated that an immediate implementation of the correction woul d result in significant payment reductions for ophthalmologists. Response: We note that for the CY 2015 MP RVU update we did not correct the mistake

that was made in CY 2010. For the CY 2015 MP update we recalculated the MP RVUs based upon the most recently available data for a ll services, including ophthalmic services. Accordingly, the proposed MP RVU update reflec ts the use of updated MP premium data and risk factors by specialty and is not affected in any way by th e CY 2010 MP RVUs. In doing so, even though the proposed CY 2015 ophthalmology non-surgical risk factor was 14 percent greater than the CY 2010 non-surgical risk factor and the proposed surgical risk factor was 17 percent greater, the proposed MP RVUs for most services with significant ophthalmology

volume decreased because the CY 2010 error resulte d in MP RVUs that were higher than they should have been. That is, the reduction in MP RVUs for ophthalmology and optometry are solely due to overpayments made due to a mist ake during the previous MP RVU update rather than a proposed change in methodology or the us e of updated premium data. We do not believeCMS-1612-FC 167

that a previous error is sufficient justificat ion for not fully implementing updated MP RVUs based on more recent premium data. Therefore, we will implement the updated MP RVUs for ophthalmology and optometry services as proposed. Comment: We received comments regarding th e application of our specialty weighted approach for calculating service level risk factors for surgical services. For instance, the same commenters that requested a 2-ye ar phase in of the reduction to ophthalmology services also requested that we exclude optometry from calcula ting the risk factor fo r ophthalmic surgery.

One commenter stated that “MP RVUs for cataract and other ophthalmic surgeries are deflated because CMS assumes that optometry is providing the surgical portion of the procedure.” The commenter also stated that opt ometrists are involved only duri ng the pre- or post-procedure periods of ophthalmic surgery. Another specialt y society stated that it appears that CMS’s methodology for calculating service le vel risk factors for surgical services “may include the allowed services for surgical assistance possibly discounted to reflect the assistant role under payment policy.” The commenter also stated that “specialties that assist at the procedure do not perform it, and the assistant’s associated MP risk factor has no bearing on the MP cost for the surgeon.” Response: The commenter is co rrect to say that we calculated service level risk factors based on the mix of all practitioners billing for a given service and that the specialty weighted approach is applied to both su rgical and non-surgical services . That is, we apply the risk factor(s) of all specialties involved with furnishi ng the surgical procedure to calculate service

level risk factors and MP RVUs. For assistants at surgery, we di scount the utilization to reflect his or her role in furnishing th e surgical procedure. Although we agree that MP cost for the surgeon may not be affected by the surgical as sistant’s MP cost, we do not agree with the suggestion that assistants at su rgery should be excluded from our specialty weighted approachCMS-1612-FC 168

for determining service level MP risk factors and MP RVUs for su rgical services. We believe it is appropriate to apply the speci alty risk factor(s) of all practitioners participating in and receiving a payment for the surgic al procedure for purposes of determining a service level risk factor and thus the payment for that service. If we were to exclude the risk factors of some specialties that bill a specific code from the cal culation of the service level risk factor, the resulting MP RVU would not refl ect all utilization. Similarly, we also disagree with the suggestion that pre- and post- utilization should be removed from determining MP RVUs for ophthalmic surgical services. Th e resources associated with pre- and post- operative periods for ophthalmic surgery are included in the total RVUs for the global surgical package. Accordingly, if we did not include the portion of utilization attributed to pre- and post-operative visits in the

calculation of service level risk factors, the MP RVUs for global surgery would overstate the MP

costs. We note that in both of these cases by using the discounted utilizati on file the weighted average that we use reflects onl y the proportion of the utilizati on by these practitioners and only at the payment rate made. Including specialty utilization for all practitioners involved in furnishing the global service reflects the MP risk for the enti re global service. Comment: We received two comments regard ing how risk factors are assigned to existing services without Medicare utilization. The commenters st ated that we crosswalk to the risk factor of an analogous source code with Medicare utilization for new codes but assign the average risk factor for all physicians to exis ting services without Me dicare utilization. The

commenters contend that “it is in appropriate for a service to have fluctuating MP risk factors simply due to whether it is repo rted in Medicare claims data fo r a given year.” The commenters requested that we crosswalk ex isting services without Medicar e utilization to a recommended

source code.CMS-1612-FC 169

Response: We used the most recently availabl e Medicare claims data (that is, from CY 2013) to determine the service level risk factors, either based on th e risk factors of the actual mix of practitioners furnishing the service, or in the case of low volume services, the risk factor of the dominant specialty. We disagree with the commenters’ suggestion to assign the risk factor of a recommended specialty to an existing service wi thout Medicare utilizatio n as indicated by our most recently available claims data. In the ab sence of Medicare utilization we continue to believe that the most appropriate risk factor is the weighted aver age risk factor for all service codes. The proposed weighted average risk fa ctor for all service codes was 2.11. Using the weighted average risk factor fo r all services effectively neutra lizes the impact of updated MP premiums and risk factors for any speci fic specialty (or mix of specialties).

Comment: The AMA and the RUC and other co mmenters agreed with the majority of our proposed claims based dominant specialty desi gnations for codes with less than 100 allowed services; however, the commenters disagreed with our proposed dominant specialty for some

services. The commenters believe that some cl aims have been miscoded, resulting in erroneous specialty designations. One commenter stated that using the dominant speci alty from the claims data resulted in unjustifiably low MP RVUs for congenital heart surgery. The commenter stated that congenital heart surgery can only be done by a heart surgeon and requested that we override the dominant specialty in our claims data and use the RUCs recommended specialty. Response: As discussed in the previous response, we proposed to use CY 2013 claims

data to determine the service level MP risk f actors, either based on the mix of practitioners furnishing the service, or in the case of low vol ume services, assigning th e risk factor of the dominant specialty. We continue to believe that use of actual claims data to determine the dominant specialty is preferable to using a “recommended” specialty. However, we recognize that anomalies in the claims data can occur that would affect the dominant specialty for lowCMS-1612-FC 170

volume services, and therefore resu lting in the need for a subjectiv e review of some services in place of a complete reliance on claims data. To that end, we reviewed the commenter’s recommendations for overriding the dominant specialty from our claims data with a recommended specialty. After careful consideration of the comments, we will override the dominant specialty from Medicare claims data when the dominant specialty from our claims data is inconsistent with a specialty that could be reasonably expected to furnish the service. For example, our claims data indicates that pulmona ry disease is the dominant specialty for HCPCS code 33622 (Reconstruction of complex cardi ac anomaly), however as the commenter mentioned, this service is furnished by heart surgeons. A complete listing of low volume services for which we will override the claims based dominant specialty with the recommended specialty to assign a service level risk factor is illust rated in Table 12.CMS-1612-FC 171

TABLE 12: Low Volume Service Codes Where Assigned Specialty Used Rather than Claims Based Dominant Specialty HCPCS

Code Short Descriptor Claims Based Dominant Specialty Assigned Specialty 25490 Reinforce radius Otolaryngology Orthopedic Surgery 26556 Toe joint transfer Pulmona ry Disease Orthopedic Surgery 31320 Diagnostic incision larynx Cardiology Otolaryngology 33620 Apply r&l pulm art bands Anesthesiology Cardiac Surgery 33621 Transthor cath for stent Cardiology Cardiac Surgery 33622 Redo compl cardiac anomaly Pu lmonary Disease Cardiac Surgery 33697 Repair of heart defects Cardiology Cardiac Surgery 33766 Major vessel shunt General Surgery Cardiac Surgery 36261 Revision of infusion pump General Practice General Surgery 43341 Fuse esophagus & intestine Gastroenterology Thoracic Surgery 43350 Surgical opening esophagus General Practice General Surgery 49491 Rpr hern preemie reduc General Practice General Surgery 50686 Measure ureter pressure Internal Medicine Urology 54352 Reconstruct urethra/penis Pediatric Medicine Urology 54380 Repair penis Gastroenterology Urology 61000 Remove cranial cavity fluid Family Practice Neurosurgery 61558 Excision of skull/sutures Family Practice Neurosurgery 61567 Incision of brain tissue Cardiology Neurosurgery 74710 X-ray measurement of pelvis Thoracic Surgery Diagnostic Radiology 96003 Dynamic fine wire emg Cardiology Physical Therapist/Independent Practice 96420 Chemo ia push technique Urology Hematology Oncology 99170 Anogenital exam child w imag Ophthalmology Pediatric Medicine 99461 Init nb em per day non-fac Cardi ac Electrophysiology Pediatric Medicine

Comment: Some commenters re quested that we crosswal k gynecological oncology to general surgery, instead of crosswalking to obstetrics/ gynecology because gynecological oncology is more akin to general surgery proced ures than obstetrics/gynecology. One specialty society stated that gynecological oncologists are predominantly cancer surgeons with MP risk similar to general surgery. Response: We agree with the commenters and will crosswalk gynecological oncology to the general surgery premium data and risk factor.CMS-1612-FC 172

Comment: One commenter requested that we crosswalk clinical la boratory to pathology

instead of the risk factor used for TC services because clinical laboratories and pathologists render essentially identical medical procedur es that are paid on the Medicare PFS. Response: We believe that the MP risk for cl inical laboratories is more akin to the MP risk of radiation therapy centers, mammography screening centers and IDTFs, for which we assigned the TC risk factor, th an to the MP risks for pathol ogists. The commenters did not provide sufficient rationale to suppo rt that MP risk for clinical la boratories is si milar to the MP risk of pathologists. Therefore, we will crosswal k clinical laboratory to the TC risk factor as proposed. Comment: One commenter encouraged us to crosswalk the interventional pain management specialty to a specia lty that more closely reflects th e risks and services associated with interventional pain management, such as in terventional radiology or a comparable surgical subspecialty. Response: We believe that the MP risk asso ciated with interventional pain management is conceptually similar to the MP risk for anesthesiology mo re so than to the MP risk for interventional radiology. Given that the comm enters did not provide sufficient rationale to support that MP risk for interven tional pain management is sim ilar to interventional radiology or to a comparable surgical specialty, we will crosswalk interventional pain management to anesthesiology as proposed.

Comment: We received contra sting comments on our proposal to crosswalk NPPs to the premium and risk factor calculated for alle rgy/immunology. For instance, one commenter acknowledged the difficulty in identifying compre hensive, accurate premium data across the majority of states, especially for NPPs. To that end, the commenter supported our decision to crosswalk the MP premiums of NPPs to the lowest physician ri sk factor, allergy/immunology.CMS-1612-FC 173

Another commenter, specifically su pported crosswalking registered di eticians to the risk factor calculated for allergy/immunology. In contrast, the AMA and other commenters did not support crosswalking NPPs with insufficient or unreliable premium data to th e premium amounts and ri sk factor used for allergy/immunology. The commenters stated th at allergy/immunology premiums overstate NPP premiums and requested that we use the genera lly lower MP survey data from the Physician Practice Information Survey (PPIS) for NPPs instead of crosswalking NPPs to the lowest physician specialty (allergy/immunology) or use some other measure of central tendency within the existing collected premium data to determin e accurate MP premium risk factors for NPPs. Another commenter suggested that we work with the AMA to obtain the necessary data to ensure the process for reviewing and updating MP rates is accurate for all providers. Response: As discussed previously in th is section, the resource-based MP RVUs are based on verifiable MP premium data. We do not believe it would be appropriate to base the MP RVUs for nonphysician specialties on survey data a nd use premium data for all other specialties. Therefore, we do not agree with the commenters that suggested using survey data for NPPs and will finalize the specialty cro sswalks for NPPs as proposed. However, in light of the commenter’s suggestions, we will explore ways to enhance our MP premium data collection efforts to obtain better premium data for NPPs fo r future updates. We will also explore other potential measures of central tendency for determ ining the “indexed” specia lty as an alternative to using the premium values of the lowest specialty.

Comment: We received two comments regard ing the data and or methodology used to

calculate the TC and PC of dia gnostic services. One specialty group noted that the proposed MP

RVUs for the TC of some di agnostic services increased wh ile the MP RVUs for the PC decreased. Specifically, the commenter questione d why the MP RVUs for the PC of diagnosticCMS-1612-FC 174

cardiac catheterization as de scribed by HCPCS codes 93451 th rough 93461 decreased by 6 to 12 percent while the TC portion for these codes in creased by 20 to 33 percent. The commenter encouraged us to review the reasons for this shift to TC MP RVUs. Additionally, the RBMA submitted updated MP premium information collected from IDTFs in 2014. The RBMA requested that we use the recently obtained data reflecting the median “50 th percentile” premium data for “umbrella non-physician MP liabili ty” for calculating CY 2015 MP RVUs for TC

services. Response: To calculate the risk factor for TC services we used the mean umbrella nonphysician MP premiums obtained from the RBMA survey data (used for the previous MP RVU update in 2010) and adjusted the data to reflect the change in non-surgical premiums for all specialties since the previous MP RVU update, for example, $9,374 deflated by -20.41 percent = $7,455. However, given that the premiums of the lowest physician specialty (allergy/immunology) decreased by more than 20 percent, the proposed CY 2015 risk factor for TC services increased from the previous update in CY 2010 from 0.86 to 0.91, resulting in minor

increases in MP RVUs for TC se rvices. However, given that th e MP RVUs for TC services are generally low, any increase to the MP RVUs co uld result in a significant percentage increase. For example, the proposed CY 2015 MP RVU for HCPCS code 93455 increased from 0.04 to 0.05 yielding a 25 percent increase. Therefore, a minor increase in MP RVUs for a TC service could result in a signific ant percentage change. We believe that using the updated RBMA premium data without further study is problematic because the updated data reflects only the median umbrella non-physician MP premium, rather than the mean as was used for the 2010 MP RVU update and the proposed 2015 MP RVU update.CMS-1612-FC 175

We believe further study is necessary to reconcile comments on the use of updated RBMA premium data for TC services (which would result in an increase MP RVU for TC services) and our curren t methodology for calculating the risk f actor for PC services relative to the global service and TC service. Therefore, we will finalize the TC premium data as proposed and maintain our current methodology for calculating the PC risk factor. We will consider the request to use the updated premium information from RBMA and alternat ives to our current methodology for calculating the PC risk factor as part of our furthe r study and would propose any changes through future rulemaking. Comment: Several commenters supported our pr oposal to classify car diac catheterization and angioplasty services as surgi cal procedures for the purpose of establishing service level risk factors. The commenters also agreed with our proposal to apply the surg ical risk factor to injection procedures used in conjunction with cardiac catheterization. The same commenters

identified additional cardiac catheterization and angioplasty services that were not included on the proposed list of invasive card iology services. Specifically, th e commenters requested that we consider adding HCPCS codes 92961, 92986, 92987, 92990, 92992, 92993, 92997, and 92998 to the list of invasive cardiology procedures classi fied as surgery for purposes of assigning service level risk factors because the MP risk for these services is similar to surgery. Response: We agree that the MP risk asso ciated with the cardiac catheterization and angioplasty services mentioned by the commenters are more akin to surgical procedures than most non-surgical services. Therefore, we will add cardiac catheteriz ation and angioplasty services as described by HCPCS c odes 92961, 92986, 92987, 92990, 92997, and 92998 to the list of services outside of the surgical HCPCS code range to be considered surgery for purposes of assigning service level MP ri sk factors. We note that HCPCS codes 92992 and 92993 are contractor-priced codes, wherein the Medicare cl aims processing contract ors establish RVUs andCMS-1612-FC 176

payment amounts for these services. Theref ore, we are not adding HCPCS codes 92992 and

92993.

Comment: One commenter stated that severa l injection codes were not included in the

list of services outside of the surgical HCPCS code range considered surgery. The commenter requested that we add inj ection services as described by HCPCS codes 93565, 93566, 93567, and 93568 to the services considered as surgery. Response: The commenter is mistaken. As discussed in the CY 2015 proposed rule (79 FR 40353 through 40354), we included the inje ction procedure codes mentioned by the

commenter on the list of services outside of th e surgical HCPCS code range to be considered surgery for purposes of assigning se rvice level MP risk factors. Comment: One commenter questioned w hy the MP RVUs decrease for cardiac catheterization services as described by HCPCS codes 93530, 93531 and 93580. The commenter stated that our proposal to assign the surgical risk fact or to invasive cardio logy services outside of the surgical HCPCS code range shoul d result in an increase in MP RVUs. Response: Cardiac catheterizations as described by HCPCS codes 93530, 93531 and 93580 are currently on the list of invasive cardiol ogy services classified as surgery for purposes of assigning service level risk factors. Therefore, the MP RVUs for HCPCS codes 93530, 93531, 93580 were calculated in the last update using the surgical risk factor applicable to the specialty(s) furnishing thes e services. As discussed previously in this section, the service level risk factors reflect the average risk factor (w eighted by allowed services) of the specialties furnishing a given service. Cha nges in the specialty mix since the previous MP RVU update in 2010 resulted in a decrease in MP RVUs for HCPCS codes 93530, 93531, and 93580. That is, the percentage of allowed servic es attributed to cardiology de creased for these service codesCMS-1612-FC 177

while the percentage of allowed services furnis hed by other specialties with risk factors lower than cardiology, such as internal medi cine and pediatric medicine, increased. Comment: Many commenters requested an explanation as to why the MP RVUs decreased for 4 out of the 6 newly bundled im age guided breast biopsy procedures. The commenters stated that given that the MP R VUs assigned to breast biopsy codes are being reduced, CMS is not appropriately capturing th e risk a physician assumes when performing a procedure to diagnose cancer. Several commenters also explained that th e misdiagnosis of breast cancer is a leading source of MP litigation and that reduction in payment for breast biopsies will have an impact on patient care. Response: For the image guided breast biops y procedures as desc ribed by HCPCS codes 19081 through 19086, we used the risk factors from source codes as recommended by the RUC. The source codes for breast biopsy codes 19081, 19082, 19083, 19084, 19085 and 19086 are HCPCS codes 32553, 64480, 32551, 64480, 36565, and 76812, respectively. Given that the proposed risk factors for HCPCS codes 32553, 64480, and 32551 decreased from 2014 to 2015, the corresponding “destination” service codes, that is HCPCS codes 19081, 19082, 19083, and

19084 also decreased.

Comment: Several commenters recommende d that we implement an annual collection and review of MP premium data and rescale th e MP RVUs each year, as we do with the PE

RVUs. The commenters also stated that an a nnual update would provide additional transparency and allow stakeholders to identify potential problems and or improvements to MP RVUs more frequently. Response: We appreciate the comments from stakeholders regarding the frequency that we currently review changes in MP premium data. As discussed in the CY 2015 PFS proposed rule (79 FR 40349 through 40355), there are two main aspects to the update of MP RVUs,CMS-1612-FC 178

recalculation of specialty risk factors based upon updated premiu m data and recalculation of service level RVUs based upon the mix of practitione rs providing the service. We will consider

the recommendation from stakeholders to conduct annual MP RVU updates to reflect corrections and changes in the mix of practitioners providing se rvices. We will also consider the appropriate frequency for collecting new MP premium data. After reviewing these issues, we would address potential changes regarding the frequency of MP RVU updates in a future proposed rule. Comment: One commenter urged us to calculat e risk factors for all specialties approved by the American Board Medical Specialties (ABM S) since 2010. The commenter stated that by using the approved ABMS specialties, all specia lties and subspecialties will be represented, including the recently approved sub-specialty of Female Pelvic Medicine and Reconstructive Surgery. Response: We calculate service level risk factors based on the mix of specialties that furnish a given service as indicated by our claims data. Medicare claims data reflects the service volume by Medicare primary specialty designations. Therefore, we can only use MP risk factors by Medicare primary specialty codes. Comment: We received two comments regard ing our discussion of how to reflect updated MP premium data under th e anesthesiology fee schedule. One commenter supported our decision to delay the anesthesia MP update and requested to work with us on developing an appropriate method for updating the MP componen t associated with anesthesia fee schedule services. Another commenter suggested using m ean anesthesia MP premiums per provider over a 4- or 5-year period prorated by Medicare utilization to yield the MP expense for anesthesia

services. The commenter stated that the calculation of premiu ms over a longer period of time renders the average more accurate and less volatil e than a calculation over a 1-year period.CMS-1612-FC 179

Response: We appreciate the comments on our potential ap proach for updating the MP

resource costs for anesthesia fee schedule services. We will consider the commenter’s suggestions to use multi-year average premiu ms as we develop a method for updating MP payments for services paid on the anesthesia fee schedule.

4. Result of Evaluation of Comments

After consideration of th e public comments received on the CY 2015 MP RVU update, we are finalizing the CY 2015 MP RVU update as proposed with minor modifications. We are crosswalking gynecological oncology to the risk f actor for general surgery (instead of the risk factor for obstetrics gynecology). We are also adding HCPCS codes 92961, 92986, 92987, 92990, 92997, and 92998 to the list of services outs ide of the surgical HCPCS code range considered as surgery for purposes of assigning service level risk fact ors. Additionally, for determining the risk factor for low volume se rvices, we are overriding the dominant specialty from our claims data with the recommended spec ialty for the low volume service codes listed in Table 12. For all other low volume services, we are finalizing our proposal to use the risk factor of the dominant specialty from our Medicare cl aims data. The MP premium amounts, specialty risk factors, and a complete list of servi ce codes outside the surg ical HCPCS code range considered surgery for the purpose of assigning se rvice level risk factor s, may be found on the CMS website under the supporting documents sec tion of the CY 2015 PFS final rule with comment period. Additional information on the CY 2015 update may be found in our contractor’s report, “Final Report on the CY 2105 Update of Malpractice RVUs,” which is available on the

CMS website. It is also located under the s upporting documents section of the CY 2015 PFS final rule with comment period located at http://www.cms.gov/PhysicianFeeSched/.CMS-1612-FC 180

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 relative cost differences among localities compared to the national average for each of the three fee schedule components (t hat is, work, PE, and MP). Although the statute requires that the PE and MP GPCIs reflect the full relative cost differences, section 1848(e)(1)(A)(iii) of the Ac t requires that the work GPCIs reflect only one-quarter of the relative cost differences compared to the nationa l 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 perm anent 1.0 PE GPCI floor for services furnished in frontier states (as define d in section 1848(e)(1)( I) of the Act) beginning January 1, 2011. Additionally, section 1848(e)(1)(E ) of the Act provided for a 1.0 floor for the work GPCIs, which was set to expire on Marc h 31, 2014. However, section 102 of the PAMA extended application of the 1.0 floor to the work GPCI through March 31, 2015. Section 1848(e)(1)(C) of the Act requires us to review and, if necessary, adjust the GPCIs at least every 3 years. Section 1848(e)(1)(C) of the Act requires that “if more than 1 year has elapsed since the date of the last previous adjust ment, the adjustment to be applied in the first year of the next adjustment shall be 1/2 of the adjustment that otherwise would be made.” We completed a review and finalized updated GPCI s in the CY 2014 PFS final rule with comment period (78 FR 74390). Since the last GPCI update had been implemented over 2 years prior, CY 2011 and CY 2012, we phased in 1/2 of the latest GP CI adjustment in CY 2014. We also revised the cost share weights that co rrespond to all three GPCIs in the CY 2014 PFS final rule with comment period. We calculated a corresponding ge ographic adjustment factor (GAF) for each PFS locality. The GAFs are a weighted composite of each area’s work, PE and MP GPCIs usingCMS-1612-FC 181

the national GPCI cost share weights. Alt hough the GAFs are not used in computing the fee schedule payment for a specific service, we provid e them because they are useful in comparing overall areas costs and payments. The actual effect on payment for any actual service will

deviate from the GAF to the extent that the proportions of work, PE and MP RVUs for the

service differ from those of the GAF. As previously noted, section 102 of the PAMA extended the 1.0 work GPCI floor through March 31, 2015. Therefore, the CY 2015 work GPCIs and summarized GAFs were

revised to reflect the 1.0 work floor. Additi onally, as required by sections 1848(e)(1)(G) and 1848(e)(1)(I) of the Act, the 1.5 work GPCI fl oor for Alaska and the 1.0 PE GPCI floor for frontier states are permanent, and th erefore, applicable in CY 2015. Comment: A few commenters requested that we extend the 1.0 work GPCI floor beyond March 31, 2015. Response: As discussed in section II.D.1, the 1.0 work GPCI floor is established by statute and expires on March 31, 2015. We do not have authority to extend the 1.0 work GPCI floor beyond March 31, 2015. As discussed in the CY 2014 PFS final rule with comment period (78 FR 74380) the updated GPCIs were calculated by a contractor to CMS. We us ed updated Bureau of Labor and Statistics Occupational Employment Statisti cs (BLS OES) data (2009 through 2011) as a replacement for 2006 through 2008 data for purpose s of calculating the work GPCI and the employee compensation component and purchased services component of the PE GPCI. We also used updated U.S. Census Bureau Ameri can Community Survey (ACS) data (2008 through 2010) as a replacement for 2006 through 2008 data for calculating the office rent component of

the PE GPCI. To calculate the MP GPCI we used updated malpractice premium data (2011 and 2012) from state departments of insuran ce as a replacement for 2006 through 2007 premiumCMS-1612-FC 182

data. We also noted that we do not adjust the medical equipment, supplies and other miscellaneous expenses component of the PE GPCI because we continue to believe there is a

national market for these items such that there is not a significant geographi c variation in relative costs. Additionally, we updated the GPCI cost sh are weights consistent with the modifications made to the 2006-based MEI cost share weights in the CY 2014 final rule with comment period.

As discussed in the CY 2014 final rule with comme nt period, use of the revised GPCI cost share weights changed the weighting of the subcompon ents within the PE GPCI (employee wages, office rent, purchased services, and medical equipm ent and supplies). For a detailed explanation of how the GPCI update was developed, see the CY 2014 final rule with comment period (78 FR 74380 through 74391). 2. Proposed Changes to the GPCI Values for the Virgin Islands Payment Locality As discussed in the CY 2015 proposed ru le (79 FR 40355 through 40356) the current methodology for calculating locality level GPCIs re lies on the acquisition of county level data (when available). Where data for a specific county are not available, we assign the data from a similar county within the same payment loca lity. The Virgin Islands have county level equivalents identified as districts. Specifically, the Virg in Islands are divided into 3 districts: Saint Croix; Saint Thomas; and Saint John. These districts are, in turn, subdivided into 20 subdistricts. Although the Virgin Is lands are divided into these c ounty equivalents, county level data for the Virgin Islands are not represente d in the BLS OES wage data. Additionally, the ACS, which is used to calculate the rent com ponent of the PE GPCI, is not conducted in the Virgin Islands, and we have not been able to obtain malpractice insurance premium data for the Virgin Islands payment locality. Given the absen ce of county level wage and rent data and the insufficient malpractice premium data by specialty type, we have historically set the three GPCI values for the Virgin Islands payment locality at 1.0.CMS-1612-FC 183

For CY 2015, we explored using the availabl e data from the Virgin Islands to more accurately reflect the geographic cost differences for the Virgin Islands payment locality as compared to other PFS localities. Although county level data for the Virgin Islands are not represented in the BLS OES wage data, aggreg ate territory level BL S OES wage data are available. We believe that using aggregate territory level data is a better reflection of the relative cost differences of operating a medical practice in the Virgin Islands payment locality as compared to other PFS localities than the curren t approach of assigning a value of 1.0. At our request, our contractor calcul ated the work GPCI, and the employee wage component and purchased services component of the PE GPCI, for the Virgin Islands payment locality using aggregated 2009 through 2011 BLS OES data. As discussed in this section, the ACS is not conducted in the Virgin Islands and we have not been able to obtain malpr actice premium data for the Virgin Islands payment locality. Therefore, we assigned a value of 1.0 for the rent index of the PE GPCI and to the MP GPCI. Using aggregate territory-level BLS OES wage data resulted in a -2.3 percent decrease in the work GPCI, a -4.48 percent decrease in the PE GPCI and a -3.2 percent decrease to the GAF for the Virgin Islands payment locality. Howeve r, with the application of the 1.0 work GPCI floor, there is no change to the work GPCI and the overall impact of using actual BLS OES wage data on the Virgin Islands payment locality is only reflected by the change in PE GPCI (-4.48 percent) resulting in a - 2.00 per cent decrease to the GAF. As mentioned previously in this section, since we have not been able to obtain malpractice premium data for the Virgin Islands payment locality we maintained the MP GPCI at 1.0. As such, we did not propose any changes

to the MP GPCI. We requested comments on our proposal to use aggregate territory-level BLS OES wage data to calculate the work GPCI and the employee wage co mponent and purchased servicesCMS-1612-FC 184

component of the PE GPCI for the Virgin Is lands payment locality beginning for CY 2015, and for future GPCI updates. However, we did not receive any specific comments on this proposal. As discussed above, we believe that using aggregate territory level BLS OES wage data is a

better reflection of the relative cost differences of operating a medical practice in the Virgin Islands payment locality as compared to other PFS localities than the current approach of assigning a value of 1.0. Therefor e, we will finalize the changes to the GPCI values for the Virgin Islands payment locality as proposed. See Addenda D and E for the CY 2015 GPCIs and summarized GAFs. Additional information on the changes to GPCI values for the Virgin Islands payment locality may be found in our contractor ’s report, “Revised Fi nal Report on the CY 2014 Update of the Geographic Practice Cost Index for the Medicare Physician Fee Schedule,” which

is available on the CMS website. It is locate d under the supporting do cuments section of the CY 2015 PFS final rule with comment period located at http://www.cms.gov/PhysicianFeeSched/

. 3. Additional Comments We received several comments on topics that are not within the scope of proposals in the CY 2015 PFS proposed rule. These comments are briefly discussed below. Comment: Many commenters continued to reques t an increase in the GPCI values for the Puerto Rico payment locality. The commenters st ated that the cost of practicing medicine in

Puerto Rico continues to rise. The commenters believe that commercial rent and utility costs, and the cost of obtaining medical equipment and supplies are highe r in Puerto Rico than many

states and territories. Commenters contend th at the data used to calculate GPCIs do not accurately reflect the cost of operati ng a medical practice in Puerto Rico. Response: Aside from proposing to use territ ory-wide wage data for the Virgin Islands payment locality, we finalized the methodology and values for the 7 th GPCI update in the CYCMS-1612-FC 185

2014 PFS final rule with comment period. We did not propose any changes to the GPCIs for the Puerto Rico payment locality, and the commente rs on the CY 2015 PFS proposed rule raised the same issues they raised in response to the pr oposed GPCI update that we finalized in CY 2014.

In the CY 2014 PFS final rule with comme nt period (78 FR 74380 through 74391), we

summarized these comments and re sponded to these issues.

Comment: A few commenters stated that GP CIs for rural areas are too low which leads to reduced numbers of rural practitioners and reduced access to care. Two commenters stated

that the PE GPCI does not account for differences in practice costs for x-rays and imaging

studies. The same commenters and another commenter also re quested that we replace the current method for calculating the work GPCIs w ith one that reflects the labor market for physicians and other health professionals as recommended by MedPAC . Another commenter raised questions about state patient compensatio n fund surcharges for malpractice insurance and the implications of those for the MP GPCI valu es. Additionally, we received a comment about the physician fee schedule payment localities. Response: As noted in th is section, we finalized the 7th GPCI update in the CY 2014 PFS final rule with comment period and, other than the proposal relating to the use of territorywide wage data for the Virgin Islands paymen t locality, we did not propose any further changes in the CY 2015 PFS proposed rule. We will consid er these points raised by commenters when we develop a proposal for the 8 th GPCI update.CMS-1612-FC 186

E. Medicare Telehealth Services 1. Billing and Payment for Telehealth Services

Several conditions must be met in order for Me dicare payments to be made for telehealth services under the PFS. Specifi cally, the service must be on th e list of Medicar e telehealth services and meet all of the following additional requirements for coverage:

● The service must be furnished via an interactive telecommunications system.

● The practitioner furnishing the service must meet the telehealth requirements, as well as the usual Medicare requirements.

● The service must be furnished to an eligible telehealth individual.

● The individual receiving the services must be in an eligible originating site. When all of these conditions are met, Medi care pays an origina ting site fee to the originating site and provides separate payment to the distant site pr actitioner furnishing the

service. Section 1834(m)(4)(F)(i) of th e Act defines Medicare telehealth services to include consultations, office visits, office psychiatry serv ices, and any additional service specified by the Secretary, when furnished via a telecommunications system. We first implemented this statutory provision, which was effective October 1, 2001, in the CY 2002 PFS final rule with comment period (66 FR 55246). We established a proces s for annual updates to the list of Medicare telehealth services as requir ed by section 1834(m)(4)(F)(ii) of the Act in the CY 2003 PFS final rule with comment period (67 FR 79988). As specified at §410.78(b), we generally require that a telehealth service be furnished via

an interactive telecommuni cations system. Under §410.78( a)(3), an interactive telecommunications system is defined as multimed ia communications equipment that includes,CMS-1612-FC 187

at a minimum, audio and video equipmen t permitting two-way, r eal-time interactive communication between the patient and dist ant site physician or practitioner. Telephones, facsimile machines, and electroni c mail systems do not meet the definition

of an interactive telecommunica tions system. An interactive telecommunications system is generally required as a condition of payment; however, section 1834( m)(1) of the Act allows the use of asynchronous ‘‘store-and-forward’’ technol ogy when the originating site is part of a federal telemedicine demonstration program in Alas ka or Hawaii. As speci fied in regulations at §410.78(a)(1), store-and-forward means the asynch ronous transmission of medical information from an originating site to be reviewed 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 practitioner furnishing the telehea lth service is not at the same location as the beneficiary. An eligible telehe alth individual means an individual enrolled under

Part B who receives a telehealth servi ce furnished at an originating site. Practitioners furnishing Medicare telehealth se rvices are reminded that these services are subject to the same non-discrimination laws as other services, including the effective communication requirements for persons with di sabilities of section 504 of the Rehabilitation Act and language access for persons with limited E nglish proficiency, as required under Title VI of the Civil Rights Act of 1964. For more information, see http://www.hhs.gov/ocr/civilrights/resources /specialtopics/hos pitalcommunication

. Practitioners furnishing Medicare telehealth serv ices submit claims for telehealth services

to the Medicare Administrative Contractors that process claims for the service area where their

distant site is located. Sec tion 1834(m)(2)(A) of the Act requ ires that a practitioner who furnishes a telehealth service to an eligible tele health individual be paid an amount equal to theCMS-1612-FC 188

amount that the practitioner would have been paid if the service had been furnished without the use of a telecommunications system. Originating sites, which can be one of several types of sites specified in the statute where an eligible telehealth individual is located at the time the service is being furnished via a telecommunications system, are pa id a fee under the PFS for each Medi care telehealth service. The statute specifies both the types of entities that can serve as originating sites and the geographic qualifications for orig inating sites. With regard to geographic qualifications, §410.78(b)(4) limits originating sites to those located in rural heal th professional shortage areas (HPSAs) or in a county that is not included in a metropolitan statis tical areas (MSAs). Historically, we have defined rural HPSAs to be those located outside of MSAs. Effective January 1, 2014, we modifi ed the regulations regarding orig inating sites to define rural

HPSAs as those located in rural census tracts as determined by the Office of Rural Health Policy (ORHP) of the Health Resources and Services Administration (HRSA) ( 78 FR 74811). Defining ‘‘rural’’ to include geographic areas located in rural census tracts within MSAs allows for

broader inclusion of sites within HPSAs as telehealth originating sites. Adopting the more precise definition of ‘‘rural’’ for this purpose expa nds access to health care services for Medicare

beneficiaries located in rural areas. HRSA has de veloped a website tool to provide assistance to potential originating sites to determine their ge ographic status. To access this tool, see the CMS

website at www.cms.gov/teleheath/

. An entity participating in a federal telemedi cine demonstration project that has been approved by, or received funding from, the Secret ary as of December 31, 2000 is eligible to be an originating site regardless of its geographic location. Effective January 1, 2014, we also changed our policy so that geographic eligibility for an originating site would be esta blished and maintained on an annua l basis, consistent with otherCMS-1612-FC 189

telehealth payment policies (78 FR 74400). Ge ographic eligibility fo r Medicare telehealth originating sites for each calenda r year is now based upon the status of the area as of December 31 of the prior calendar year. For a detailed history of telehealth paymen t policy, see 78 FR 74399. 2. Adding Services to the List of Medicare Telehealth Services As noted previously, in the December 31, 2002 Federal Register (67 FR 79988), we established a process for adding services to or deleting services from the list of Medicare

telehealth services. This process provides the public with an ongoing opportunity to submit requests for adding services. Under this proc ess, we assign any qualif ying request to make

additions to the list of telehealth services to one of two categories. Revisions to criteria that we use to review requests in the second categ ory were finalized in the November 28, 2011 Federal Register (76 FR 73102). The two categories are:

● Category 1: Services that are similar to professional c onsultations, 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, a practitioner with the beneficiary in the originating site. We also look for similarities in the telecommunications system used to deliver the proposed service; for example, the use of interactive audio and video equipment.

● Category 2: Services that ar e not similar to the current 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 furnished 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 aCMS-1612-FC 190

telecommunications system in furnishing the ca ndidate telehealth service produces clinical benefit to the patient. Submitte d evidence should include both a de scription of relevant clinical

studies that demonstrate the serv ice furnished by telehealth to a Medicare beneficiary improves the diagnosis or treatment of an illness or injury or improves the functioning of a malformed body part, including dates and findings, and a list and copies of pub lished peer reviewed articles

relevant to the service when furnished via telehea lth. Our evidentiary standa rd of clinical benefit

does not include minor or incidental benefits. Some examples of clinical be nefit include the following:

● 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 wi thout 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 hospi talizations or physician visits.

● More rapid beneficial resolution of the disease process treatment.

● Decreased pain, bleeding, or ot her quantifiable symptom.

● Reduced recovery time.

For the list of covered telehealth services, see the CMS website at www.cms.gov/teleheath/ . Requests to add servic es to the list of Medicare telehealth services

must be submitted and received no later than December 31 of each calendar year to be considered for the next rulemaking cycle. For example, qualifying requests submitted before the

end of CY 2014 will be considered for the CY 2016 proposed rule. Each request to add a serviceCMS-1612-FC 191

to the list of Medicare telehealth services must include any suppor ting documentation the requester wishes us to consider as we revi ew the request. Because we use the annual PFS rulemaking process as a vehicle for making changes to the list of Medicare telehealth services, requestors should be advised that any informati on 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, see the CMS website at www.cms.gov/telehealth/

. 3. Submitted Requests to the List of Telehealth Services for CY 2015 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 stated in the CY 2012 final rule with comment period (76 FR 73098), we believe that the category 1 cr iteria not only streamline our review process for publicly reques ted services that fall into th is category, th e criteria also expedite our ability to identify codes for the tele health list that resemble those services already

on this list. a. Submitted Requests We received several requests in CY 2013 to a dd various services as Medicare telehealth services effective for CY 2015. The following pres ents a discussion of these requests, and our proposals for additions to the CY 2015 telehealth list. Of the requests received, we find that the following services are sufficiently similar to psychiatric diagnostic procedures or office/outpatient visits currently on the teleheal th list to qualify on a category one basis. Therefore, we propose to add the following services to the telehealth list on a category 1 basis for

CY 2015:CMS-1612-FC 192

● CPT codes 90845 (Psychoanalysis); 90846 (fam ily psychotherapy (without the patient present); and 90847 (family psychot herapy (conjoint psychotherapy) (with patient present);

● CPT codes 99354 (prolonged service in the offi ce or other outpatient setting requiring direct patient contact beyond the usual service; fi rst hour (list separately in addition to code for office or other outpatient evaluation and manage ment service); and, 99355 (prolonged service in the office or other outpatient setting requiring di rect patient contact be yond the usual service; each additional 30 minutes (list separately in a ddition to code for prol onged service); and,

● HCPCS codes G0438 (annual wellness visit; includes a personalized prevention plan of service (pps), initial visit; and, G0439 (a nnual wellness visit, includes a personalized prevention plan of service (pps), subsequent visit). We also received requests to add services to the telehealth list that do not meet our criteria for being on the Medicare telehealth list. We did not propose to add the following procedures for the reasons noted:

● CPT codes 92250 (fundus photography with interpretation and report); 93010 (electrocardiogram, routine ECG with at least 12 leads; inte rpretation and re port only), 93307 (echocardiography, transthoracic, real-time with image documen tation (2d), includes m-mode recording, when performed, complete, without spectral or color Doppl er echocardiography; 93308 (echocardiography, transthor acic, real-time with image documentation (2d), includes mmode recording, when performed, fo llow-up or limited study); 93320 (Doppler echocardiography, pulsed wave and/or continuous wave with spectral display (list separately in addition to codes for echocardiographic imag ing); complete); 93321 (Doppler echocardiography, pulsed wave and/or continuous wave with spectral display (list separately in addition to codes for echocardiographic imaging); follow-up or limited st udy (list separately in addition to codes for echocardiographic imaging); and 93325 (Doppler echocardiography color flow velocity mappingCMS-1612-FC 193

(list separately in addition to codes for echoc ardiography). These services include a technical component (TC) and a professional component (P C). By definition, the TC portion of these

services needs to be furnished in the same loca tion as the patient and th us cannot be furnished via telehealth. The PC portion of these servi ces could be (and typically would be) furnished without the patient being pr esent in the same location. (Note: For services that have a TC and a PC, there is sometimes an entirely different code that is used when onl y the PC portion of the service is being furnished, and other times the sa me CPT code is used with a –26 modifier to indicate that only the PC is being billed.) For example, the interpretati on by a physician of an actual electrocardiogram or electroencepha logram tracing that has been transmitted electronically, can be furnished without the patient being present in the same location as the physician. Given the nature of these services, it is not necessary to consider including the PC of

these services for addition to the telehealth list. When these PC services are furnished remotely, they do not meet the definition of Medicare telehealth services under section 1834(m) of the Act. Rather, these remote services are considered phys icians’ 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), and should be reported in the same way as other physicians’ services (that is, without the –GT or –GQ modifiers).

● CPT codes 96103 (psychological testing (i ncludes psychodiagnostic assessment of emotionality, intellectual abiliti es, personality and psychopathology, eg, MMPI), administered by a computer, with qualified health care prof essional interpretation and report); and, 96120 (neuropsychological testing (eg, Wisconsin Card So rting Test), administered by a computer, with qualified health care professional interpretation and report). These serv ices involve testing by computer, can be furnished remotely without the patient being present, and are payable in theCMS-1612-FC 194

same way as other physicians’ services. These remote services are not Medicare telehealth services as defined under the Act; therefore, we need not consider them for addition to the telehealth list, and the restrictions that apply to telehealth services do not apply to these services.

● CPT codes 90887 (interpretation or explanation of results of psychiatric, other medical examinations and procedures, or other accumulated data to family or other responsible persons, or advising them how to assist patient); 99090 (analysis of clinical data stored in computers (eg, ECGs, blood pressures, hematol ogic data); 99091 (collection a nd interpretation of physiologic data (eg, ECG, blood pressure, glucose monitori ng) digitally stored and/or transmitted by the patient and/or caregiver to the physician or othe r qualified health care pr ofessional, qualified by education, training, licensure/regul ation (when applicable) requiri ng a minimum of 30 minutes of time); 99358 (prolonged evaluation and management se rvice before and/or after direct patient care; first hour); and 99359 (pro longed evaluation and management service before and/or after direct patient care; each additi onal 30 minutes (list separately in addition to code for prolonged service). These services are not separately payable by Medicare. It would be inappropriate to

include services as telehealth services when Medicare does not otherwise make a separate payment for them.

● CPT codes 96101 (psychological testing (i ncludes psychodiagnostic assessment of emotionality, intellectual abilities, personal ity and psychopathology, eg, MMPI, Rorschach, WAIS), per hour of the psychologist’s or physicia n’s time, both face-to-face time administering tests to the patient and time interpreting thes e test results and prep aring the report); 96102 (psychological testing (includes psychodiagnosti c assessment of emotionality, intellectual abilities, personality and psychopathology, eg, MM PI and WAIS), with qualified health care professional interpretation and repor t, administered by technician, per hour of technician time, face-to-face); 96118 (neuropsychol ogical testing (eg, Halstead-Reitan NeuropsychologicalCMS-1612-FC 195

Battery, Wechsler Memory Scales and Wiscons in Card Sorting Test), per hour of the psychologist’s or physician’s time, both face-to-f ace time administering tests to the patient and time interpreting these test results and prepar ing the report); and, 96119 (neuropsychological testing (eg, Halstead-Reitan Neuropsychological Battery, W echsler Memory Scales and Wisconsin Card Sorting Test), wi th qualified health care profe ssional interpretation and report, administered by technician, per hour of technici an time, face-to-face). These services are not similar to other services on the telehealth list, as they require close observation of how a patient responds. The requestor did not submit evidence supporting the clinical benefit of furnishing these services on a category 2 basis. As such, we did not propose to add these services to the list

of telehealth services.

● CPT codes 57452 (colposcopy of the cervix including upper/adjacent vagina; 57454 colposcopy of the cervix including upper/adjacen t vagina; with biopsy(s) of the cervix and endocervical curettage); and, 57460 (colposcopy of the cervix incl uding upper/ad jacent vagina; with loop electrode biopsy(s) of the cervix). These services are not similar to other services on

the telehealth service list. Th erefore, it would not be appropria te to add them on a category 1 basis. The requestor did not submit evidence su pporting the clinical bene fit of furnishing these services on a category 2 basis. As such, we did not propose to add these se rvices to the list of

telehealth services.

● HCPCS code M0064 (brief office visit for th e sole purpose of monitoring or changing drug prescriptions used in the treatment of ment al psychoneurotic and personality disorders) is being deleted for CY 2015. This code was created specifically to describe a service that is not subject to the statutory outpatient mental hea lth limitation, which limited payment amounts for

certain mental health services. Section 102 of the Medicare Improvements for Patients and Providers Act (Pub. L. 110– 275, enacted on July 15, 2008) (MIPPA) required that the limitationCMS-1612-FC 196

on payment for outpatient mental health treatment to 62.5 percent of incurred expenses, in effect since the inception of the Medicare program, be reduced over four years. This limitation on payment for mental health treatment created a hi gher share of beneficiary coinsurance for these

services than for most other Medicare serv ices paid under the PFS. Effective January 1, 2014, 100 percent of expenses incurred fo r mental health treatment servic es are considered as incurred for purposes of Medicare, resulting in the same beneficiary cost sharing for these services as for

other PFS services. Since the statute was amende d to phase out the limitation, and the phase-out was complete effective January 1, 2014, Medicare no longer has a need to distinguish services subject to the mental health limitation from thos e that are not. Accordingly, the appropriate CPT code can now be used to bill Medicare for the services that would have otherwise been reported using M0064 and M0064 will be eliminated as a telehealth service, effective January 1, 2015.

● Urgent Dermatologic Problems and Wound Care—The American Telemedicine Association (ATA) cited several st udies to support adding dermatol ogy services to the telehealth list. However, the request did not include specific codes. Since we did not have specific codes to consider for this request, we cannot evaluate whether the serv ices are appropriate for addition to the Medicare telehealth services list. We note that some of the services that the requester had in mind may be billed under the telehealth o ffice visit codes or the telehealth consultation

G-codes. In summary, we proposed to add the following co des to the telehealth list on a category 1

basis:

● Psychotherapy services CPT codes 90845, 90846 and 90847.

● Prolonged service office CPT codes 99354 and 99355.

● Annual wellness visit HCPC S codes G0438 and G0439. 3. Modifying §410.78 Regarding List of Telehealth ServicesCMS-1612-FC 197

As discussed in section II.E.2. of this final rule with comment period, under the statute, we created an annual process for considering the a ddition of services to th e Medicare telehealth list. Under this process, we propose services to be added to the list in the proposed rule in response to public nominations or our own initia tive and seek public comments on our proposals. After consideration of public comments, we finali ze additions to the list in the final rule. We have also revised §410.78(b) each year to include the description of the added services. Because

the list of Medicare telehealth services has grown quite length y, and given the other mechanisms by which we can make the public aware of the list of Medicare telehealth se rvices for each year, we proposed to revise §410.78(b) by deleting the description of th e individual services for which Medicare payment can be made when furnished via telehealth. Under this proposal, we would continue our current policy to address requests to a dd to the list of teleh ealth services through the PFS rulemaking process so that the public would have the opportunity to comment on additions to the list. We also proposed to revise §410.78(f) to indicate that a list of Medicare telehealth codes and descriptors is av ailable on the CMS website. The following is a summary of the comment s we received regarding the proposed

addition of services to the list of Medicare telehealth services. Comment: All commenters supported one or more of our proposals to add psychotherapy services (CPT codes 90845, 90846 and 90847); prolonged service office (CPT codes 99354 and 99355); and annual wellness visit (HCPCS code s G0438 and G0439) to the list of Medicare

telehealth services for CY 2015. Response: We appreciate the commenters’ s upport for the proposed additions to the list

of Medicare telehealth services. After consideration of the public comments received, we are finalizing our CY 2015 proposal to a dd these services to the list of telehealth services for CY 2015 on a category 1 basis.CMS-1612-FC 198

Comment: Commenters also agreed with our rationale for rejec ting other requested additions to the telehealth list. However, one commenter disagreed with our decision not to propose adding dermatology services, including those furnished using store-and-forward technology, to the list of te lehealth services. Another commente r objected to our proposal not to add psychological testing se rvices to the telehealth services list. Response: As we noted in the proposed rule , the request to add dermatology services did not include specific codes. Wit hout specific codes to consider, we cannot evaluate whether the services are appropriate for additi on to the Medicare telehealth services list. We note that some of the services that the requester had in mind may be billed under the telehealth office visit codes

or the telehealth consultation G–codes. Concerning payment for services furnished using store-and-forward technology, we note

that the statute at section 1861(m) of the Act includes st ore-and-forward technology as a telecommunication system for telehealth services only in the case of federal telemedicine demonstration programs in Al aska and Hawaii (see §410.78(d)). Concerning psychological testing services, we noted that remote services (CPT codes 96103 and 96120) are not Medicare telehealth services as defined under the Act and thus can be furnished when beneficiary is not in the same place as the practitioner. It would also be counterproductive to add these codes to the telehealth li st because, if we did, the telehealth originating site, geographic, and other restrictions would apply to these services. CPT codes 90887, 90991, 93358 and 99359 are not sepa rately payable by Medicare. It would be inappropriate to incl ude services as telehealth se rvices when Medicare does not otherwise make a separate payment for them. Finally, CPT codes 96101, 96102, 96118 and 96119 are not similar to other services on the telehealth list, as they require close observa tion of how a patient resp onds. The requestor didCMS-1612-FC 199

not submit evidence supporting the clinical benef it of furnishing these services on a category 2 basis. As such, we did not propose to add these services to the list of telehealth services. We received other public comments on matters related to Medicare telehealth services that were not the subject of proposals in th e CY 2015 PFS proposed rule. Because we did not make any proposals regarding these matters, we ge nerally do not summarize or respond to such comments in the final rule. However, we are summarizing and responding to the following comments to acknowledge the interests and concer ns of the commenters, and a mechanism to

address some of those concerns. Many commenters supported the overa ll expansion of telehealth by:

● Removing geographic restrictions to include both rural and urban areas.

● Revising permissible originating sites to in clude a patient’s home, domiciliary care and first responder vehicles.

● Adopting a broader definition of telehealth technologies to include services provide via mobile technology, including emails, phone calls , and store-and-forward technologies.

● Adding physical and occupationa l therapists as practitioners who can remotely furnish

telehealth services.

● Adding more services to the telehealth list, including servic es under category 2.

● Prioritizing coverage of se rvices that include care c oordination with the patient’s medical home and/or existing treating physicians.

● Considering the use of tele health technology for the purpo se of furnishing direct supervision of services furnished by on-site practitioners.

● Using demonstration projec ts under CMS’s Center fo r Medicare and Medicaid Innovation (CMMI) to collect clinical evidence on the effect of expandi ng telehealth and to address how telemedicine can be integrated into new payment and delivery models.CMS-1612-FC 200

Response: We appreciate the commenters’ sugg estions. As some commenters noted, we do not have authority to implement many of thes e revisions under the curre nt statute. The CMS Innovation Center is responsible for developing and testing ne w payment and service delivery models to lower costs and improve quality for Me dicare, Medicaid, and CHIP beneficiaries. As part of that authority, the CMS Innovation Ce nter can consider pot ential new payment and service delivery models to test changes to Me dicare’s telehealth payment policies. In summary, after consideration of the co mments we received, we are finalizing our proposal to add psychotherapy services CP T codes 90845, 90846 and 90847; prolonged service office CPT codes 99354 and 99355; and annual we llness visit HCPCS codes G0438 and G0439

to the list of Medicare telehealth services. In addition, we are finalizing our proposal to change our regulation at §410.78(b) by deleting the description of the individual services for which Medicare payment can be made

when furnished via telehealth. We will continue our current policy to address requests to add

services to the list of Medicare telehealth se rvices through the PFS rulemaking process so that the public has the opportunity to comment on additi ons to the list. We are also finalizing our proposal to revise §410.78(f) to indi cate that a list of Medicare tele health codes and descriptors is

available on the CMS website.

We remind all interested stakeholders that we are currently soliciting public requests to

add services to the list of Medicare telehealth services. To be consid ered during PFS rulemaking for CY 2016, these requests must be submitte d and received by December 31, 2014. Each request to add a service to the li st of Medicare telehealth serv ices must include any supporting documentation the requester wishes us to cons ider as we review the request. For more information on submitting a request for an addition to the list of Medicare telehealth services,CMS-1612-FC 201

including where to mail these requests, we refer readers to the CMS website at www.cms.gov/telehealth/

. 5. Telehealth Originating Site Fa cility Fee Payment Amount Update Section 1834(m)(2)(B) of the Ac t establishes the Medicare telehealth originating site facility fee for telehealth se rvices furnished from October 1, 2001, through December 31 2002, at $20.00. For telehealth services furnished on or af ter January 1 of each subsequent calendar year, the telehealth originating site facility fee is increased by the percentage increase in the MEI as defined in section 1842(i)(3) of the Act. The ME I increase for 2015 is 0.8 percent. Therefore, for CY 2015, the payment amount for HCPCS code Q3014 (Telehealth originating site facility fee) is 80 percent of the le sser of the actual charge or $24.83. The Medicare telehealth originating site facility fee a nd MEI increase by the applicable time period is shown in Table 13.

TABLE 13: The Medicare Telehealth Originat ing Site Facility Fee and MEI Increase by the Applicable Time Period Facility Fee MEI Increase Period

$20.00 N/A 10/01/2001 – 12/31/2002 $20.60 3.0% 01/01/2003 – 12/31/2003 $21.20 2.9% 01/01/2004 – 12/31/2004 $21.86 3.1% 01/01/2005 – 12/31/2005 $22.47 2.8% 01/01/2006 – 12/31/2006 $22.94 2.1% 01/01/2007 – 12/31/2007 $23.35 1.8% 01/01/2008 – 12/31/2008 $23.72 1.6% 01/01/2009 – 12/31/2009 $24.00 1.2% 01/01/2010 – 12/31/2010 $24.10 0.4% 01/01/2011 – 12/31/2011 $24.24 0.6% 01/01/2012 – 12/31/2012 $24.43 0.8% 01/01/2013 – 12/31/2013 $24.63 0.8% 01/01/2014 – 12/31/2014 $24.83 0.8% 01/01/2015 – 12/31/2015CMS-1612-FC 202

F. Valuing New, Revised and Potentially Misvalued Codes Establishing valuations for newly created a nd revised CPT codes is a routine part of maintaining the PFS. Since inceptio n of the PFS, it has also been a priority to revalue services regularly to assure that the payment rates reflect the changing trends in the practice of medicine and current prices for inputs used in the PE calculations. Initially, this was accomplished primarily through the five-year review process, which resulted in revised RVUs for CY 1997, CY 2002, CY 2007, and CY 2012. Under the five-year review process, revisions in RVUs were proposed in a proposed rule and finalized in a final rule. In addition to the five-year reviews, in each year beginning with CY 2009, CMS and the RU C have identified a number of potentially misvalued codes using various identification scre ens, such as codes with high growth rates, codes that are frequently bill ed together, and high expenditure codes. Section 3134 of the

Affordable Care Act codified the misvalued code initiative in section 1848( c)(2)(K) of the Act. In the CY 2012 rulemaking process, we proposedand finalized consolidation of the fiveyear review and the potentially misvalued code activities into an annua l review of potentially

misvalued codes to avoid redundancies in thes e efforts and better accomplish our goal of assuring regular assessment of code values. Unde r the consolidated proc ess, we issue interim

final RVUs for all revaluations and new codes in the PFS final rule with comment period, and make payment based upon those values during th e calendar year covered by the final rule. (Changes in the PFS methodology that may affect valu ations of a variety of codes are issued as proposals in the proposed rule.) We consider and respond to any public comments on the interim final values in the final rule with comment peri od for the subsequent year. When consolidating these processes, we indicated that it was appropria te to establish interim values for new, revised, and potentially misvalued codes because of th e incongruity between the PFS rulemaking cycle and the release of codes by the AMA CPT Editori al Panel and the RUC review process. WeCMS-1612-FC 203

stated that if we did not estab lish interim final values for revalu ed codes in the final rule with comment period, “a delay in implementing revised va lues for codes that ha ve been identified as misvalued would perpetuate payment for the services at a rate that does not appropriately reflect

the relative resources involved in furnishi ng the service and would continue unwarranted distortion in the payment for other services across the PFS.” We also reiterated that if we did not

establish interim final values for new and revised c odes, we would either have to delay the use of new and revised codes for one year, or permit ea ch Medicare contractor to establish its own payment rate for these codes. We stated, “We belie ve it would be contrary to the public interest to delay adopting values for new and revised codes for the initial year, especially since we have an opportunity to receive significant input fr om the medical community [through the RUC] before adopting the values, and the alternatives coul d produce undesirable levels of uncertainty and inconsistency in payment for a year.” 1. Current Process for Valuing New, Re vised, and Potentially Misvalued Codes Under the process finalized in the CY 2012 PFS final rule with comment period, in each year’s proposed rule, we propose sp ecific codes and/or groups of codes that we believe may be appropriate to consider under our potentially misval ued code initiative. As part of our process for developing the list of proposed potentially mi svalued codes, we consider public nominations for potentially misvalued codes under a process also established in the CY 2012 PFS final rule with comment period. If appropriate, we incl ude such codes in our proposed potentially misvalued code list. In the proposed rule, we solicit comments on the proposed potentially misvalued codes. We then respond to comment s and establish a fina l list of potentially

misvalued codes in the final rule for that year. These potentia lly misvalued codes are reviewed and revalued, if appropriate, in subsequent years. In addition, the RUC regularly identifiesCMS-1612-FC 204

potentially misvalued codes using screens that have previously b een identified by CMS, such as codes performed together more than 75 percent of the time. Generally, the first step in revaluing codes that have been identified as potentially

misvalued is for the RUC to review these code s through its standard process, which includes active involvement of national specia lty societies for the sp ecialties that ordinar ily use the codes. Frequently, the RUC’s discussion of potentially misvalued codes will lead the CPT Editorial Panel to make adjustments to the codes involved, such as bundling of codes, creation of new

codes or revisions of code desc riptors. The AMA has estimated that 75 percent of all annual CPT coding changes result from the poten tially misvalued code initiative. The RUC provides CMS with recommendations fo r the work values and direct PE inputs for the codes we have identified as potentiall y misvalued codes or, in the case of a coding revision, for the new or revised codes that will re place these potentially misvalued codes. (This process is also applied to codes that the RU C identifies using code screens that we have identified, and to new or revised codes that are issued for reasons unrelated to the potentially misvalued code process.) Generally, we receive the RUC recommendations concurrently for all codes in the same family as the potentially misv alued code(s). We belie ve it is important to evaluate and establish appropriate work and MP RVUs and direct PE inputs for an entire code family at the same time to avoid rank order anomalies and to maintain appropriate relativity among codes. We generally receive the RUC r ecommendations for the code or replacement code(s) within a year or two following the identif ication of the code as potentially misvalued. We consider the RUC recommendations along with other information that we have, including information submitted by other stakeholders, and establish interim final RVUs for the potentially misvalued codes, new codes, and an y other codes for which there are coding changes in the final rule with comment pe riod for a year. There is a 60

− day period for the public toCMS-1612-FC 205

comment on those interim final values after we issu e the final rule. For services furnished during the calendar year following the pub lication of interim final rates, we pay for services based upon

the interim final values established in the final ru le. In the final rule with comment period for the subsequent year, we consider and respond to publ ic comments received on the interim final values, and make any appropriate adjustments to values based on those comments. We then typically finalize the values for the codes.

As we discussed in the CY 2012 PFS final ru le with comment period, we adopted this consolidated review process to combine all coding revaluations into one annual process allowing for appropriate consideration of relativity in a nd across code families. In addition, this process

assures that we have the bene fit of the RUC recommendations for all codes being valued.

2. Concerns with Current Process.

Some stakeholders who have e xperienced reductions in paymen ts as the result of interim final valuations have objected to the process by which we revise or establish values for new, revised, and potentially misvalued codes. Some ha ve stated that they di d not receive notice of the possible reductions before they occurred. Generally, stakeholders are aware that we are considering changes in the payment rates for part icular services either because CPT has made changes to codes or because we have identified the codes as potentially misvalued. As the RUC considers the appropriate value for a service, repr esentatives of the specialties that use the codes are involved in the process. The RUC usually surveys physicians or other practitioners who furnish the services described by the codes regard ing the time it takes to furnish the services, and representatives of the speci alty(ies) also participate in the RUC meetings where

recommendations for work RVUs and direct PE inputs are considered. Through this process, representatives of the affected specialties are generally aware of the RUC recommendations.CMS-1612-FC 206

Some stakeholders have stated that even when they are aware that the RUC has made recommendations, they have no opportunity to respond to the RUC recommendations before we consider them in adopting interim final valu es because the RUC actions and recommendations are not public. Some stakeholders have also said that the individuals w ho participate in the RUC review process are not able to share the recommendations because they have signed a confidentiality agreement. We not e, however, that at l east one specialty soci ety has raised funds via its website to fight a “pe nding cut” based upon its knowledge of RUC recommendations for specific codes prior to CMS action on the recommendation. Additionally, some stakeholders have pointed out that some types of suppliers that are paid under the PFS are not permitted to participate in the RUC process at all. We recognize that some stakeholders, in cluding those practiti oners represented by societies that are not participants in the RUC pr ocess, may not be aware of the specifics of the

RUC recommendations before we consider them in establishing interim final values for new, revised, and potentially misvalued codes. We note that, as described above, before we review a service as a potentially misvalued code, we go through notice and comment rulemaking to identify it as a potentially misvalued code. Thus, the public has notice and an opportunity to

comment on whether we should review the values for a code before we finalize the code as potentially misvalued and begin the valuation pro cess. As a result, all stakeholders should be aware that a particular code is being considered as potential ly misvalued and that we may

establish revised interim final va lues in a subsequent final rule with comment period. As noted above, there may be some codes for which we receive RUC recommendations based upon their identification by the RUC through code screens that we establish. These codes are not specifically identified by CMS through notice an d comment rulemaking as potentially misvalued codes. We recognize that if stakeholders are not monitoring RUC activities or evaluatingCMS-1612-FC 207

Medicare claims data, they may be unaware that these codes are being reviewed and could be

revalued on an interim final basis in a fi nal rule with comment period for a year. In recent years, we have increased our sc rutiny of the RUC recommendations and have increasingly found cause to modify the values recommended by the RUC in establishing interim

final values under the PFS. Sometimes we also fi nd it appropriate, on an interim final basis, to

refine how the CPT codes are to be used for Medi care services or to crea te G-codes for reporting

certain services to Medicare. Some stakeholders have objected to such interim final decisions because they do not learn of the CMS action until the final rule with comment period is issued. Stakeholders said that they do not have an opportunity to meaningfully comment and for CMS to address their comments before the coding or valuation decision takes effect.

We received comments on the CY 2014 PFS final rule with comment period suggesting that the existing process for revi ew and adoption of interim final values for new, revised, and misvalued codes violates section 1871(a)(2) of the Act, which prescribes the rulemaking requirements for the agency in establishing paymen t rates. In response to those commenters, we note that the process we use to establish interim final rates is in full acco rdance with the statute and we do not find this a persuasive reason to co nsider modifying the process that we use to

establish PFS rates. Our recent revaluation of the four epidural injection codes provides an example of the concerns that have been expressed with the exis ting process. In the CY 2014 PFS final rule with comment period, we established interim final valu es for four epidural injection codes, which resulted in payment reductions for the services when furnished in the office setting of between 35 percent and 56 percent. (In th e facility setting, the reducti ons ranged from 17 percent to 33 percent.) One of these codes had been identified as a potentially misvalued code 2 years earlier. The affected specialties had been involved in th e RUC process and were generally aware that theCMS-1612-FC 208

family of codes would be revalued on an inte rim basis in an upcoming rule. They were also aware that the RUC had made significant changes to the direct PE inputs, including removal of the radiographic-fluoroscopy room, wh ich explains, in large part, th e reduction to values in the office setting. The societies representing the affect ed specialty were also aware of significant reductions in the RUC-recommended “time” to furnish the procedures based on the most recent survey of practitioners who furn ish the services, which resulted in reductions in both the work and PE portion of the values. Although the specia lties were aware of th e changes that the RUC was recommending to direct PE inputs, they were not specifically awar e of how those changes would affect the values and paym ent rate. In addition, we decreased the work RVUs for these procedures because we found the RUC-recommende d work RVUs did not adequately reflect the

RUC-recommended decreases in ti me. This decision is consistent with our general practice

when the best available information shows that the time involved in furnishing the service has decreased, and in the absence of information sugge sting an increase in work intensity. Since the

interim final values for these codes were issu ed in the CY 2014 PFS final rule with comment period, we have received numerous comments that will be useful to us as we consider finalizing values for these codes. If we had followed a pr ocess that involved proposing values for these codes in a proposed rule, we would have been able to consider the additional information contained in these comments prior to making payments for the services based upon revised values. (See section II.B.3.b.(2) of this final rule with comment period for a discussion of proposed valuation of these epidur al injection codes for CY 2015.)

3. Alternatives to the Current Process In the proposed rule, we noted that gi ven our heightened review of the RUC recommendations and the increased concerns expr essed by some stakeholders, we believed that an assessment of our process for valuing these codes was warranted. To that end, we consideredCMS-1612-FC 209

potential alternatives to addre ss the timing and rulemaking issues associated with establishing values for new, revised and potentially misvalue d codes (as well as for codes within the same families as these codes). Specifically, we explor ed three alternatives to our current approach:

● Propose work and MP RVUs and direct PE inputs for all new, revised and potentially misvalued codes in a proposed rule.

● Propose changes in work and MP RVUs and direct PE inputs in the proposed rule for new, revised, and potentially misvalued codes for which we receive RUC recommendations in time; continue to establish interim final values in the final rule for other new, revised, and potentially misvalued codes.

● Increase our efforts to make available more information a bout the specific issues being considered in the course of developing values for new, revised and potentially misvalued codes to increase transparency, but without making ch anges to the existing process for establishing

values. In the proposed rule we discussed each of these alternatives as follows. (a) Propose work and MP RVUs and direct PE inputs for new, re vised, and potentially misvalued codes in the proposed rule: Under this approach, we stated that we w ould evaluate the RUC recommendations for all new, revised, and potentially misvalued codes, and include proposed work and MP RVUs and direct PE inputs for the codes in the first av ailable PFS proposed rule. We would receive and consider public comments on those proposals and es tablish final values in the final rule. The primary obstacle to this approach relates to the current timing of the CPT coding changes and

RUC activities. Under the current calenda r, all CPT coding changes and most RUC

recommendations are not available to us in time to include proposed values for all codes in the proposed rule for that year.CMS-1612-FC 210

Therefore, we stated that if we were to adopt this propos al, which would require us to propose changes in inputs before we revalue co des based upon those values, we would need a mechanism to pay for services for which the exis ting codes would no longer be available, or for which there would be changes for a given year.

As we noted in the CY 2012 PFS final rule with comment period, the RUC

recommendations are an essential element that we consider when valuing codes. Likewise, we recognize the significant contribu tion that the CPT Editorial Pane l makes to the success of the potentially misvalued code initia tive through its consideration and adoption of coding changes. Although we have increased our scrutiny of th e RUC recommendations in recent years and accepted fewer of the recommendations without making our own refinements, the CPT codes

and the RUC recommendations conti nue to play a major role in our valuations. For many codes, the surveys conducted by specialty societies as part of the RUC process are the best data that we have regarding the time and intensity of wor k. The RUC determines the criteria and the methodology for those surveys. It also reviews the survey results. This process allows for development of survey data that are more reliab le and comparable across specialties and services than would be possible without ha ving the RUC at the center of the survey vetting process. In addition, the debate and discussi on of the services at the RUC meetings in which CMS staff participate provides a good understanding of what the service entails an d how it compares to other services in the family, and to services fu rnished by other specialties. The debate among the specialties is also an important part of this pr ocess. Although we increa singly consider data and information from many other sources, and we in tend to expand the scope of those data and sources, the RUC recommendations remain a vital part of our valuation process. Thus, if we were to adopt this approach, we would need to address how to make payment

for the services for which new or revised codes ta ke effect for the following year but for whichCMS-1612-FC 211

we did not receive RUC recommendations in ti me to include proposed work values and PE inputs in the proposed rule. Because the a nnual coding changes are effective on January 1 st of each year, we would need a mechanism for pract itioners to report se rvices and be paid appropriately during the interval between the date the code takes effect and the time that we receive RUC recommendations and complete rule making to establish values for the new and revised codes. One option would be to estab lish G-codes with identi cal descriptors to the predecessors of the new and revised codes and, to the fullest extent po ssible, carry over the existing values for those codes. This would e ffectively preserve the status quo for one year. The primary advantage of this approach woul d be that the RVUs for all services under the PFS would be established using a full notice and comment procedure, including consideration of the RUC recommendations, before they take effect. In addition to having the benefit of the RUC recommendations, this would provide the public the o pportunity to comment on a specific proposal prior to it being implemen ted. This would be a far more transparent process, and would assure that we have th e full benefit of stakeholder comments before establishing values. One drawback to such a process is that the use of G-codes for a significant number of codes may create an administrative burden fo r CMS and for practitioners. Presumably, practitioners would need to use the G-codes to report certain services fo r purposes of Medicare, but would use the new or revised CPT codes to repor t the same services to private insurers. The number of G-codes needed each year would de pend on the number of CPT code changes for

which we do not receive the RUC recommendati ons in time to formulate a proposal to be included in the proposed rule for the year. To the extent that we receive the RUC

recommendations for all new and revised codes in time to develop proposed values for inclusion in the proposed rule, there would be no n eed to use G-codes for this purpose.CMS-1612-FC 212

Another drawback is that we would need to delay for at least one year the revision of values for any misvalued codes for which we do not receive RUC recommendations in time to include a proposal in the proposed rule. For a sel ect set of codes, we would be continuing to use the RVUs for the codes for an additional year even though we know they do not reflect the most accurate resources. Since the PFS is a budget ne utral system, misvalued services affect payments for all services across the fee schedule. On the other hand, if we were to take this approach, we would have the full benefit of pub lic comments received on the proposed values for potentially misvalued services before implementing any revisions. (b) Propose changes in work and MP RVUs and PE inputs in the proposed rule for new, revised, and potentially misval ued codes for which we receive RUC recommendations in time;

continue to establish interim final values in the final rule for other new, revised, and potentially

misvalued codes: This alternative approach would allow fo r notice and comment rulemaking before we adopt values for some new, revised and potentia lly misvalued codes (those for which we receive RUC recommendations in time to include a proposal in the proposed rule), while others would be

valued on an interim final basi s (those for which we do not recei ve the RUC recommendations in time). Under this approach, we would establis h values in a year for all new, revised, and potentially misvalued codes, and there would be no need to provide for a mechanism to continue payment for outdated codes pendi ng receipt of the RUC recomme ndations and completion of a rulemaking cycle. For codes for which we do not receive the RUC recommendations in time to include a proposal in the proposed rule for a ye ar, there would be no change from the existing valuation process. This would be a balanced approach that rec ognizes the benefits of a full opportunity for notice and comment rulemaking before establ ishing rates when timing allows, and theCMS-1612-FC 213

importance of establishing appropriate values for the current version of CPT codes and for potentially misvalued codes when the timing of the RUC recommendations does not allow for a full notice and comment procedure. However, this alternative would go only part of the way toward addressing concerns expressed by some stakeholders. For those codes for which the RUC recommendations are not received in time for us to include a proposal in the proposed rule, Medicare payment for one year would still be based on inputs established withou t the benefit of full public notice and comment. Another concern with this approach is that it could lead to the va luation of codes within the same family at different times depe nding on when we receive RUC recommendations for each code within a family. As discussed previously, we be lieve it is important to value an entire code family together to make adjustments to account a ppropriately for relativity within the family and between the family and other families. If we receive RUC recommendations in time to propose values for some, but not for all, codes within a family, we would respond to comments in the final rule to establish final values for some of the codes while adopting interim final values for other codes within the same family. The differen ces in the treatment of codes within the same family could limit our ability to value codes within the same family with appropriate relativity. Moreover, under this alternative, the main determinant of how a code would be handled would be the timing of our receipt of the RUC reco mmendation for the code. Although this approach would offer stakeholders the oppor tunity to comment on specific proposals in the proposed rule, the adoption of changes for a separate group of c odes in the final rule could significantly change the proposed values simply due to the budget ne utrality adjustments due to additional codes being valued in the final rule. (c) Increase our efforts to make available more information about the specific issues being considered in the course of developing values for new, revised and potentially misvaluedCMS-1612-FC 214

codes in order to increase transparency, but without a change to th e existing process for establishing values:

The main concern with conti nuing our current approach is that stakeholders have expressed the desire to have adequate and timel y information to permit the provision of relevant feedback to CMS for our consideration prior to establishing a payment rate for new, revised, and potentially misvalued codes. We could addre ss some aspects of this issue by increasing the transparency of the current process. Specifical ly, we could make more information available on

the CMS website before interim final values ar e established for codes. Examples of such information include an up-to-date list of all c odes that have been id entified as potentially misvalued, a list of all codes for which RUC r ecommendations have been received, and the RUC

recommendations for all codes for which we have received them. Although the posting of this information would significantly increase transparency for all stakeholders, it still would not allow for full not ice and comment rulemaking procedures before values are established for payment purposes. Nor would it provide the public with advance

information about whether or how we will make refinements to the RUC recommendations or coding decisions in the final rule with comment period. Thus, stakeholde rs would not have an opportunity to provide input on our potential m odifications before interim final values are adopted. 4. Proposal to Modify the Pro cess for Establishing Values for New, Revised, and Potentially

Misvalued Codes. After considering the current process, incl uding its strengths a nd weaknesses, and the alternatives to the current process described pr eviously, we proposed to modify our process to make all changes in the work and MP RVUs an d the direct PE inputs for new, revised and potentially misvalued services under the PFS by proposing the changes in the proposed rule,CMS-1612-FC 215

beginning with the PFS proposed rule for CY 2016. We proposed to include proposed values for all new, revised and potentially misvalued codes for which we have complete RUC recommendations by January 15 th of the preceding year. We also proposed to delay revaluing the code for one year (or until we receive RU C recommendations for the code before January

15 th of a year) and include proposed values in the following year’s rule if the RUC

recommendation was not received in time for incl usion in the proposed rule. Thus, we would include proposed values prior to using the new co de (in the case of new or revised codes) or revising the value (in the case of potentially misv alued codes). Due to the complexities involved in code changes and rate sett ing, there could be some circumstances where, even when we receive the RUC recommendations by January 15 th of a year, we are not able to propose values in that year’s proposed rule. For example, we might not have recommendations for the whole family or we might need additiona l information to appropriately valu e these codes. In situations where it would not be appropriate or possible to propose values for certain new, revised, or potentially misvalued codes, we would treat them in the same way as those for which we did not receive recommendations before January 15 th

. For new, revised, and potentially misvalued codes for which we do not receive RUC recommendations before January 15 th of a year, we proposed to adopt coding policies and payment rates that conform, to the extent possi ble, to the policies and rates in place for the previous year. We would adopt these conformi ng policies on an interim basis pending our

consideration of the RUC recommendations and the completion of notice and comment rulemaking to establish values for the codes. Fo r codes for which there is no change in the CPT code, it is a simple matter to co ntinue the current valuation. Fo r services for which there are CPT coding changes, it is more complicated to maintain the current payment rates until the codes can be valued through the notice and comment ru lemaking process. Since the changes in CPTCMS-1612-FC 216

codes are effective on January 1 st of a year, and we would not ha ve established values for the new or revised codes (or other codes within th e code family), it woul d not be practical for

Medicare to use those CPT codes. For codes that were revised or delete d as part of the annual CPT coding changes, when the changes could affect the value of a code and we have not had an opportunity to consider the re levant RUC recomme ndations prior to the proposed rule, we propose to create G-codes to describe the predece ssor codes to these codes. If CPT codes are

revised in a manner that would not affect the re source inputs used to value the service (for example, a grammatical changes to CPT code desc riptors), we could use these revised codes and continue to pay at the rate de veloped through the use of the same resource inputs. For example, if a single CPT code was separated into two codes and we did not receive RUC

recommendations for the tw o codes before January 15 th of the year, we would assign each of

those new codes an “I” status indi cator (which denotes that the c odes are “not valid for Medicare purposes”), and those codes could not be used fo r Medicare payment during the year. Instead,

we would create a G-code with the same descri ption as the single predecessor CPT code and continue to use the same inputs as the predecessor CPT code fo r that G-code during the year. For new codes that describe wholly new servic es, as opposed to new or revised codes that are created as part of a coding revision of a fami ly or that describe se rvices are already on the PFS, we would make every effort to work with the RUC to ensure that we receive

recommendations in time to incl ude proposed values in the propos ed rule. However, if we do not receive timely recommendations from the RUC fo r such a code and we determine that it is in the public interest for Medicare to use a new code during the code’s initial year, we would

establish values for the code’s in itial year. As we do under our cu rrent policy, if we receive the

RUC recommendations in time to consider them for the final rule, we propos e to establish values for the initial year on an interim final basis subjec t to comment in the final rule. In the event weCMS-1612-FC 217

do not receive RUC recommendations in time to c onsider them for the fi nal rule, or in other situations where it would not be appropriate to establish interim final values (for example, because of a lack of necessary information a bout the work or the price of the PE inputs involved), we would contractor pri ce the code for the initial year. We specifically sought comments on the following topics:

● Is this proposal preferable to the present process? Is another one of the alternatives

better?

● If we were to implement th is proposal, is it better to m ove forward with the changes,

or is more time needed to make the transi tion such that implementation should be delayed beyond CY 2016? What factors should we cons ider in selecting an implementation date?

● Are there alternatives other than the use of G-codes that would allow us to address the annual CPT changes through notice and comment rather than interim final rulemaking? Comment: The vast majority of commenter s support a process, such as the one we proposed, that would result in having an opportunity for public comment on specific CMS proposals to change rates prior to payments being made based upon those rates. Commenters supporting a more transparent pr ocess include most medical or ganizations. MedPAC supported including proposals for rate changes in the propose d rule, but disagreed with preserving existing

rates when RUC recommendations we re not received in time to valu e in the proposed rule stating that this perpetuates paying at rates that we know are misvalued. As an alternative, MedPAC suggested that for codes for which we received RUC recommendations after the deadline for the proposed rule, we establish interim final values using the existing pro cess. MedPAC also encouraged us to work with the CPT Editori al Panel and the RUC to better disseminate information about coding and payment recommendati ons that might be used for interim values as far in advance as possible. Several commente rs who do not currently participate in theCMS-1612-FC 218

development of RUC recommendations suggested that we require the RUC to make its operations more transparent. Mo st of the commenters that suppor ted the proposal also suggested making at least some modifications to the pr oposal. Some commenters indicated there was no need for a change from the current process. Another commenter stated “CMS’s proposal is overly complex, potentially burdensome, and goe s well beyond the principal request of the medical specialty societies and Congress – that is, for CMS to publish reimbursement changes for misvalued codes in the proposed rule, as opposed to waiting until the final rule.” Response: We appreciate the many comments in support of our proposal to be more transparent in our ratesetting pr ocess by including proposed change s in inputs for new, revised, and potentially misvalued codes in the PFS proposed rules each year. We received only minimal comments on the other alternatives we presen ted, and only one comment suggesting that the current process was ideal and should be maintaine d. Thus, we are finalizing the proposal, with the modifications discussed below, to change our process for establishing values for new, revised, and potentially misvalued codes each year by proposing values for them in the proposed

rule. We note that the CPT Editorial Panel and th e RUC have made significant efforts in recent years to make their processes more transparent, such as making minutes of meetings publicly available. We encourage them to continue thes e efforts and also to consider ways that all physicians, practitioners and other suppliers paid under the PFS are aw are of issues that are being considered by the RUC, and have an opportunity to provide input. With regard to comments suggesting that we propose values for some codes in the proposed rule a nd establish values for

others as interim final in the final rule with comment period, as we discussed in making the proposal, we believe this type of system has several flaws. Most significantly, since the PFS is a budget neutral system, proposals are more meaningful when they can be cons idered in relation to all codes being revalued in a year in order to allow public comment on the entire fee schedule atCMS-1612-FC 219

one time. Additionally, we believe it is difficu lt to justify the presence or absence of an opportunity for public comment in advance of our adopting and using new values and inputs for services when the outcome essentially depends upon when we receive RUC recommendations. Comment: Commenters expressed mixed opinions on when the new process should begin. The AMA, the RUC, and most medi cal specialties opposed the proposed CY 2016 implementation and asked that it be delaye d until CY 2017. Commenters supporting a delay suggested that much work had already been done for the CY 2016 coding cycle in anticipation that these codes could be used for CY 2016, and stated it seems unfair to now delay valuing these codes because the process is being change d. These commenters also suggested that by delaying until CY 2017, the CPT Ed itorial Panel and the RUC would have time to adjust their agendas and workload so as to provide more recommendations in time for the proposed rule. By contrast, several commenters, in cluding those with major code revisions for CY 2015, such as codes for radiation therapy and upper gastrointe stinal procedures, suggested that we should implement the new process immediately, and thus , delay implementation of the new code sets and values so that they could be issued as proposals in the CY 2016 proposed rule. Although each of the commenters took some unique positio ns in supporting a delay, they emphasized the importance of the opportunity to comment on our specific proposals for valuation as a major consideration for the delay. A few other commen ters also suggested that the benefit of the opportunity for public comment prior to changing values warrants immediate implementation. Some commenters supported a CY 2016 implementation date as we proposed. A small group of commenters suggested an interim approach under which, for CY 2016, we would publish “some, but not all, values” in the proposed rule and use the interim final a pproach for others. Response: After reviewing the comments, we understand that the implementation of a new process such as this one will affect stakeholders in differing ways. As we consider the mostCMS-1612-FC 220

appropriate time frame for implementation, we belie ve that flexibility in implementation offers the optimal solution. Accordingly, we are delayi ng the adoption of two new codes sets (radiation therapy and lower gastrointestinal endoscopies) until CY 2016 as requested by affected stakeholders so that those most affected by these significant changes have the opportunity to comment on our proposals for valuing these code s sets before they are implemented. (See section II.G.3 of this final rule.) Similarly, as requested by the AMA and most other medical specialty societies, we are delaying the complete implementation of this pr ocess so that those who have requested new

codes and modifications in existi ng codes with the exp ectation that they would be valued under the PFS for CY 2016 will not be negatively affected by timing of this change. We note that the AMA has been working to develop timeframes th at would allow a much higher percentage of codes to be addressed in the pr oposed rule, and has shared with us some plans to achieve this goal. We appreciate AMA’s efforts and are confiden t that with the finaliza tion of this process,

the CPT Editorial Panel and the RUC will be able to adjust their timelines and processes so that most, if not all, of the annual coding changes and valuation recommendations can be addressed in the proposed rule prior to the effective da te of the coding changes. This delay in implementation will provide additional time for these bodies to adjust their agendas and the timing of their recommendations to CMS to more appropriately align with the new process. As suggested by some commenters, we will use CY 2016 as a transition year. In the PFS proposed rule for CY 2016, we will propose values for the new, revised and potentially misvalued codes

for which we receive the RUC recommendations in time for inclusion in the CY 2016 proposed rule. We will also include proposals for the two code sets delayed from CY 2015 in the CY 2016 proposed rule, as discussed above. For those ne w, revised, and potential ly misvalued codes for

which we do not receive RUC reco mmendations in time for inclusion in the proposed rule, weCMS-1612-FC 221

anticipate establishing in terim final values for them for CY 2016, consistent with the current process. Beginning with valuations for CY 2017, the new process will be app licable to all codes. In other words, beginning with rulemaking fo r CY 2017, we will propose values for the vast majority of new, revised, and potentially misval ued codes and consider public comments before establishing final values for the c odes; use G-codes as necessary in order to facilitate continued payment for certain services for which we do not receive RUC recommendations in time to propose values; and adopt interim final values in the case of wholly new se rvices for which there are no predecessor codes or values and for wh ich we do not receive RUC recommendations in time to propose values. Consistent with this policy, we are finalizing our proposed regulatory change to §414.24 with the addition of the phras e “For valuations for calendar year 2017 and beyond,” to paragraph (b) to reflect the im plementation for all CY 2017 valuations.” Comment: Commenters also addressed the January 15 th deadline for valuations to be considered for the proposed rule. The AMA recommended a deadline of 30 days after the RUC’s January meeting to allow time to submit complete recommendations for the proposed rule. Many others supported this, with some co mmenters suggesting a variety of dates between January 31 st and April. Commenters sugge sted using an April deadline so that we could include the recommendations from the April RUC meeting in the proposed rule. Response: In proposing a deadline for incl usion in the proposed rule, we attempted to strike a balance that allows CMS adequate time for CMS to do a thorough job in vetting recommendations and formulating proposals, and allows the RUC as much time as possible to complete its activities. Review of RUC recommendations and application of the PFS methodology to particular codes re quires significant time to complete. With new statutory requirements being implemented in CY 2017, such as those requiring multi-year transitions of certain changes in values and modification to PFS payments if specified targets are not met, weCMS-1612-FC 222

believe we will need more time to complete th e process of formulating proposals. We believe

that we need to establish a consistent deadlin e for receipt of RUC recommendations in order to allow all stakeholders and CMS to plan appropria tely. To balance competing priorities, we are finalizing a deadline of February 10 th . Our ability to complete our work in this more limited time will depend in large part on the volume of reco mmendations handled at the last RUC meeting

and when we receive those recommendations. We are seeking the RUC’s assistance in minimizing the recommendations that we re ceive after the beginni ng of the year. Comment: The majority of commenters opposed the use of G-codes, primarily citing the administrative burden of having to use a separa te set of codes for Medicare claims. One commenter called the G-code proposal “unworka ble.” In addition, MedPAC objected to the principal of attempting to maintain rates that are known to be misval ued. Those supporting the use of G-codes generally recognized the administ rative burden, but believ ed the importance of the opportunity for public comment on proposed valu es before they take effect outweighed the administrative inconvenience. Commenters urged us to minimize the use of G-codes. Response: We recognize the commenters’ conc erns with the use of G-codes. We agree that it is preferable to use CPT codes whenever po ssible. Under our finalized process, the use of G-codes for the purpose of holding over current coding and payment policies should not be necessary, generally, as long as we receive RU C recommendations for all new, revised and potentially misvalued c odes before February 10 th of the prior year. However, we need to preserve our ability to establis h a proxy for current coding and va lues in situations where we

receive the RUC recommendations too late or , for some other reason, encounter serious difficulty developing proposed values for revise d code sets. In the proposed rule, we sought input as to ways to achieve this without using G-codes. The only suggestion offered by

commenters was to value such codes on an interim final basis. As we discuss above, we believeCMS-1612-FC 223

the program and its stakeholders are better served by delaying reva luations for one year while we used the notice and comment process to obtain public comments in advance. The comments on this proposal were overa ll overwhelming supportive of this point of view. Accordingly, we are not foreclosing the possibility of using G-codes for this purpose when warranted by the circumstances. However, we are cognizant of th e difficulties created by the use of G-codes and

will seek to minimize their use. We also note th at the RUC and stakeholders can assist us in minimizing the use of G-codes by taking steps to insure that we receive RUC recommendations as early as possible.

5. Refinement Panel.

As discussed in the 1993 PFS final rule with comment period (57 FR 55938), we adopted a refinement panel process to assist us in reviewing the public comments on CPT codes with interim final work RVUs for a year and in develo ping final work values for the subsequent year. We decided the panel would be comprised of a multispecialty group of physicians who would

review and discuss the work involved in each procedure under review, and then each panel member would individually rate the work of the procedure. We believed establishing the panel with a multispecialty group would balance the interests of the specialty societies who commented on the work RVUs with the budgetary a nd redistributive effects that could occur if we accepted extensive increases in work RVUs across a broad range of services. Following enactment of secti on 1848(c)(2)(K) of the Act, wh ich required the Secretary periodically to review potentially misvalued codes and make appropriate adjustments to the RVUs, we reassessed the refineme nt panel process. As detailed in the CY 2011 PFS final rule with comment period (75 FR 73306), we continue d using the established refinement panel process with some modifications. As we considered making changes to the pr ocess for valuing code s, we reassessed theCMS-1612-FC 224

role that the refinement panel pr ocess plays in the code valuati on process. We noted that the current refinement panel process is tied to interi m final values. It provides an opportunity for stakeholders to provide new clin ical information that was not av ailable at the time of the RUC valuation that might affect work RVU values that are adopted in the interi m final value process. We noted that if our proposal to modify the va luation process for new, revised, and potentially misvalued codes is adopted, there would no longer be interim final values except for very few codes that describe totally new services. Thus , we proposed eliminating the refinement panel

process. We also noted that by using the proposed process for new, revised, and potentially misvalued codes, we believed the consideration of additional clinical information and any other issues associated with the CMS proposed valu es could be addressed through the notice and comment process. Similarly, prior to CY 2012 wh en we consolidated the five-year valuation, changes made as part of the five-year review process were addressed in the proposed rule and those codes were generally not subject to the refinement process. The notice and comment process would provide stakeholders with complete information on the basis and rationale for our proposed inputs and any relating coding policies. We also noted that an increasing number of requests for refinement do not include new clinical information that would justify a change in the

work RVUs and that was not available at the time of the RUC meeting, in accordance with the current criteria for refinement. Thus, we did not believe the elimination of the refinement panel process would negatively affect the code valuation process. We believe the proposed process, which includes a full notice and comment proce dure before values are used for purposes of payment, offers stakeholders a better mechan ism for providing any additional data for our consideration and discussing any co ncerns with our proposed values than the current refinement

processCMS-1612-FC 225

Comment: We received many comments on ou r proposal to eliminate the refinement panel, but most addressed problems with th e existing refinement process and suggested improvements and alternatives rather than reas ons not to eliminate the refinement panel. Concerns with the refinement panel process in cluded that CMS imposed too high a standard for referring codes to refinement and that CM S decreasingly changed values based upon the refinement panel results. Some noted that organizations with limited resources are disadvantaged compared to those with signific ant resources to overturn any CMS interim final values without a refinement process. In addition, some commenters stated that elimination of the refinement panel runs contrary to the transparency that CMS is trying to achieve. Many discussed their previous understa nding that the refinement pane l was essentially an appeals process for interim final values. Commenters supported “a fair, objective, and consistently applied appeals process that would be open to any commenting organization. ” Commenters expressed concern that the elimination of the refinement panel without a replacement mechanism “indicates that CMS will no longer seek the independent advice of contra ctor medical officers and practicing physicians and will solely rely on Agency staff to determine if the comment is persuasive in modifying a proposed value. The lack of any perceived orga nized appeal process will likely lead to a fragmented lobbying effort, rather than an objective review process.” MedPAC suggested that we use a panel w ith membership limited to those without a financial stake in the process, such as contract or medical directors, ex perts in medical economics and technology diffusion, private payer representati ves, and a mix of physi cians and other health professionals not directly affected by the RVUs in question. It also suggested user fees to provide the resources needed or such a refinement panel. Response: We acknowledge the commenters’ concer ns and believe that some of theCMS-1612-FC 226

dissatisfaction with the current refinement pane l mechanism stems from the expectation that it constitutes an appeals process. We do not ag ree. We believe the pur pose of the refinement panel is to give us additional information to cons ider in exercising our re sponsibility to establish appropriate RVUs for Medicare services. Like many of the commenters, we believe the refinement panel is not achiev ing its purpose. Rather than providing us with additional information to assist us in establishing work RVUs, most often the refi nement panel discussion

reiterates the issues raised and information disc ussed at the RUC. Since we had access to this

information at the time interim final values we re established, it seems unlikely that a repeat

discussion of the same issues would lead us to change valuations based upon information that already had been carefully cons idered. We remain concerned about the amount of resources devoted to refinement panel activities as compared to the benefit received. However, in light of the significant concerns raised by commenters, we are not fina lizing our proposal to eliminate the refinement panel. We will use the refinement panel for consideration of interim final rates for CY 2015 under the existing rules. We will al so explore ways to address the many concerns

that we and stakeholders have about the refinement panel pro cess and whether the change in process eliminates the need for a refinement panel. We are also finalizing our proposed ch ange to the regulation at §414.24 with the addition of the phrase “For valuations for cal endar year 2017 and beyond,” to paragraph (b) to reflect implementation of the revised process fo r all valuations beginni ng with those for CY

2017.CMS-1612-FC 227 G. Establishing RVUs for CY 2015 1. Methodology

We conducted a review of each code identified in this section and reviewed the current work RVU, if one exists, the RUC-recommended work RVUs, intensity, and time to furnish the preservice, intraservice, and posts ervice activities, as well as othe r components of the service that

contribute to the value. Our review generally incl udes, but is not limited to, a review of information provided by the RUC, Health Care Professionals Advisory Committee (HCPAC), and other public commenters, medical literature , and comparative databases, as well as a comparison with other codes within the Medicar e PFS, consultation with other physicians and health care professionals within CMS and the federal government. We also assessed the methodology and data used to develop the recommendations submitted to us by the RUC and other public commenters and the rationale for the recommendations. In the CY 2011 PFS final rule with comment period (75 FR 73328 th rough 73329), we discusse d a variety of methodologies and approaches used to devel op work RVUs, including survey data, building blocks, crosswalk to key reference or sim ilar codes, and magnitude estimation. More

information on these issues is available in that rule. When referring to a survey, unless otherwise noted, we mean the surveys conducte d by specialty societies as part of the formal RUC process. The building block methodology is used to construc t, or deconstruct, the work RVU for a CPT code based on component pieces of the code. Components used in the building block approach may include preservice, intraservice, or posts ervice time and post-pro cedure visits. When referring to a bundled CPT code, the component s could be the CPT codes that make up the bundled code. Magnitude estimation refers to a methodology for valuing physician work that determines the appropriate work RVU for a se rvice by gauging the total amount of physicianCMS-1612-FC 228

work for that service relative to the physician work for similar service across the PFS without explicitly valuing the com ponents of that work. The PFS incorporates cross-specialty and cross- organ system relativity. Valuing services requires an assessment of relative value and takes into account the clinical intensity and time required to furnish a service. In selecting which methodological approach will best determine the appropriate value for a service, we consider the current and recommended work and time values, as well as the intensity of the se rvice, all relative to other services. Several years ago, to aid in the development of preservice time r ecommendations for new and revised CPT codes, the RUC created standardized preservice time packages. The packages include preservice evaluation time, preservice positioning time, and preservice scrub, dress and wait time. Currently there are six preservice time packages for services typically furnished in the facility setting, reflecting the di fferent combinations of straight forward or difficult procedure, straightforward or difficult patient , and without or with sedation/an esthesia. Currently, there are three preservice time packages for services typically furnished in the nonfacility setting, reflecting procedures without and wi th sedation/anesthesia care. We have developed several standard building block methodologies to appropriately value services when they have common billing patterns. In cases where a service is typically furnished to a beneficiary on the same day as an evalua tion and management (E/M) service, we believe that there is overlap between th e two services in some of the activities furnished during the preservice evaluation and postservice time. We believe that at le ast one-third of the physician time in both the preservice evaluation and postser vice period is duplicative of work furnished during the E/M visit. Accordingly, in cases wher e we believe that the RUC has not adequately accounted for the overlapping activities in the reco mmended work RVU and/or times, we adjust

the work RVU and/or times to account for the overlap. The work RVU for a service is theCMS-1612-FC 229 product of the time involved in furnishing the servi ce times the intensity of the work. Preservice evaluation time and postservice time both have a long-established intensit y of work per unit of time (IWPUT) of 0.0224, which means that 1 minute of preservice evaluation or postservice time equates to 0.0224 of a work RVU. Therefore, in many cases when we remove 2 minutes of preservice time and 2 minutes of postservice time from a procedure to account for the overlap with the same day E/M service, we also remove a work RVU of 0.09 (4 minutes × 0.0224 IWPUT) if we do not believe th e overlap in time has already been accounted for in the work RVU. The RUC has recognized this valuation policy and, in many cases, addresses the overlap in time and work when a service is typically provided on the same day as an E/M service. The RVUs and other payment information for all CY 2015 payable code s are available in Addendum B. The RVUs and other payment in formation for all codes subject to public

comment are available in Addendum C. Both addenda are available on the CMS website under

downloads for the CY 2015 PFS final rule with comment period at http://www.cms.gov/physicianfeesched/downloads/. The time values for all CY 2015 codes are listed in a file called “CY 2015 PFS Physician Time,” available on the CMS website under

downloads for the CY 2015 PFS final rule with comment period at http://www.cms.gov/physicianfeesched/downloads/. 2. Addressing CY 2014 Interim Final RVUs In this section, we are responding to the pub lic comments received on specific interim

final values established in the CY 2014 PFS final rule with comment period and discussing the final values that we are establishing for CY 2015. The final CY 2015 work, PE, and MP RVUs

are in Addendum B of a file called “CY 2015 PF S Addenda,” available on the CMS website

under downloads for the CY 2015 PFS fi nal rule with comment period at http://www.cms.gov/physicianfeesched/ PFS-Federal-Regulation-Notices.html/ . The direct PECMS-1612-FC 230 inputs are listed in a file cal led “CY 2015 PFS Direct PE Inputs,” available on the CMS website

under downloads for the CY 2015 PFS fi nal rule with comment period at http://www.cms.gov/physicianfeesched/ PFS-Federal-Regulation-Notices.html/

. a. Finalizing CY 2014 Interim Final Work RVUs for CY 2015 (i) Refinement Panel (1) Refinement Panel Process

As discussed in the 1993 PFS final rule with comment period (57 FR 55938), we adopted a refinement panel process soon after implementing the fee schedule to assist us in reviewing the public comments on CPT codes with interim fina l work RVUs and in developing final work values for the subsequent year. We decided the panel would be comprised of a multispecialty group of physicians who would review and disc uss the work involved in each procedure under review, and then each panel member would indivi dually rate the work of the procedure. We believed a multispecialty group would balance th e interests of the sp ecialty societies who commented on the work RVUs with the budgetary a nd redistributive effects that could occur if we accepted extensive increases in work RVUs across a broad range of services. Depending on the number and range of codes that are subject to refinement in a given year, we establish refinement panels with representatives from f our groups: Clinicians representing the specialty identified with the procedures in question; phy sicians with practices in related specialties; primary care physicians; and contractor medical directors (CMDs). Typical panels have included 8 to 10 physicians across the four groups. Following the addition of section 1848(c)(2)(K) to the Act, which requires the Secretary periodically to review potentially misvalued codes and make appropriate adjustments to the RVUs, we reassessed the refineme nt panel process. As detailed in the CY 2011 PFS final rule with comment period (75 FR 73306), we believed that the refinement panel process mightCMS-1612-FC 231 provide an opportunity to review and discuss the proposed and in terim final work RVUs with a clinically diverse group of expe rts, who could provide informed recommendations following the discussion. Therefore, we indicated that we would continue the refinement process, but with

administrative modification and clarification. We also noted that we w ould continue using the established panel composition that includes repr esentatives from the four groups—clinicians representing the specialty identified with the pr ocedures in question, physi cians with practices in related specialties, primar y care physicians, and CMDs. At that time, we made a change in how we calculated refinement panel results. The basis of the refinement panel process is that, followi ng discussion of the information but without an attempt to reach a consensus, each member of th e panel submits an independent rating to CMS. Historically, the refinement pane l’s recommendation to change a work value or to retain the interim final value had hinged solely on the outcome of a statistical test on the ratings (an F-test of panel ratings among the groups of participants). Over time, we found the statistical test used to evaluate the RVU ratings of individual pane l members became less reliable as the physicians in each group tended to select a previously disc ussed value, rather than developing a unique value, thereby reducing the observe d variability needed to conduc t a robust statis tical test. In addition, reliance on values developed using the F- test also occasionally resulted in rank order anomalies among services (that is, a more comple x procedure is assigned lower RVUs than a less complex procedure). As a result, we eliminated the use of the statistical F-test and replaced it with the median work value of the individual pa nel members’ ratings. We stated that this approach would simplify the refinement process administratively, while pr oviding a result that reflects the summary opinion of the panel me mbers based on a commonly used measure of central tendency that is not significantly affected by outlier values. We also clarified that we have the final authority to set the work RVUs , including making adjustments to the work RVUsCMS-1612-FC 232 resulting from the refinement process, and that we will make such adjustments if warranted by policy concerns (75 FR 73307). We remind readers that the refinement panels are not intended to review the work RVUs for every code for which we did not accept the RUC-recommended work RVUs. Rather, refinement panels are designed for situations wh ere there is new clinical information available that might provide a reason for a change in wo rk values and where a multispecialty panel of physicians might provide input that would assist us in establishing work RVUs. To facilitate the

selection of services for the refinement panels, commenters seek ing consideration by a refinement panel should specifically state in their public comments that they are requesting refinement panel review. Furthermore, we have asked commenters requesting refinement panel review to submit any new clinical information c oncerning the work require d to furnish a service

so that we can consider whether the new inform ation warrants referral to the refinement panel (57 FR 55917). We note that most of the information presen ted during the last several refinement panel discussions has been duplicative of the inform ation provided to the RUC during its development of recommendations and considered by CMS in es tablishing values. As detailed above, we

consider information and recommendations from the RUC when assignin g proposed and interim final RVUs to services. Thus, if the only in formation that a commenter has to present is information already considered by the RUC, referral to a refineme nt panel is not appropriate. We request that commenters s eeking refinement panel review of work RVUs submit supporting information that has not already been considered by the RUC in developing recommendations or by CMS in assigning proposed and interim final work RVUs. We can make best use of our resources, as well as those of the specialties and physicia n volunteers involved, by avoiding duplicative consideration of inform ation by the RUC, CMS, and a re finement panel. To achieveCMS-1612-FC 233 this goal, CMS will continue to critically evaluate the need to refer codes to refinement panels in future years, specifically considering a ny new information provided by commenters. (2) CY 2014 Interim Final Work RVUs Considered by the Refinement Panel We referred to the CY 2014 refinement pane l 19 CPT codes with CY 2014 interim final work values for which we received a request fo r refinement that met the requirements described above. For these 19 CPT codes, all commenters requested increased work RVUs. For ease of discussion, we will be referring to these services as “refinement codes.” Consistent with the process described above, we convened a multi-specia lty panel of physicians to assist us in the review of the information submitted to support in creased work RVUs. The panel was moderated by our physician advisors, and consiste d of the following voting members:

● One to two clinicians represen ting the commenting organization.

● One to two primary care clinicians nomi nated by the American Academy of Family Physicians and the American College of Physicians.

● Four Contractor Me dical Directors (CMDs).

● One to two clinicians with practices in re lated specialties, who we re expected to have knowledge of the services under review. The panel process was designed to capture each participant’s independent judgment and his or her clinical experience which informed a nd drove the discussion of the refinement code during the refinement panel proceedings. Follo wing the discussion, each voting participant rated the work of the refinement code(s) and submitted those ratings to CMS directly and confidentially. We note th at not all voting participants voted for every CPT code. There was no attempt to achieve consensus among the panel me mbers. As finalized in the CY 2011 PFS final rule with comment period (75 FR 73307), we calcu lated the median value for each service based upon the individual ratings that were s ubmitted to CMS by panel participants.CMS-1612-FC 234 Table 14 presents information on the work RVUs for the refinement codes, including the refinement panel ratings and the final CY 2015 wo rk RVUs. In section II.G.2.a.ii., we discuss the CY 2015 work RVUs assigned each of the individual refinement codes.CMS-1612-FC 235 TABLE 14: Codes Reviewed by the 2014 Multi-Specialty Refinement Panel

HCPCS

Code Descriptor CY 2014 Interim

Final Work RVU RUC Recommended

Work RVU Refinement Panel Median Rating CY 2015 Work RVU

19081 Biopsy of breast accessed through the skin with stereotactic guidance 3.29 3.29 3.40 3.29

19082 Biopsy of breast accessed through the skin with stereotactic guidance 1.65 1.65 1.78 1.65

19083 Biopsy of breast accessed through the skin with ultrasound guidance 3.10 3.10 3.10 3.10

19084 Biopsy of breast accessed through the skin with ultrasound guidance 1.55 1.55 1.55 1.55

19085 Biopsy of breast accessed through the skin with MRI guidance 3.64 3.64 3.64 3.64

19086 Biopsy of breast accessed through the skin with MRI guidance 1.82 1.82 1.82 1.82

19281 Placement of breast localization devices accessed through the skin with mammographic guidance 2.00 2.00 2.00 2.00

19282 Placement of breast localization devices accessed through the skin with mammographic guidance 1.00 1.00 1.00 1.00

19283 Placement of breast localization devices accessed through the skin with stereotactic guidance 2.00 2.00 2.00 2.00

19284 Placement of breast localization devices accessed through the skin with stereotactic guidance 1.00 1.00 1.00 1.00

19285 Placement of breast localization devices accessed through the sk in with ultrasound guidance 1.70 1.70 1.70 1.70

19286 Placement of breast localization devices accessed through the sk in with ultrasound guidance 0.85 0.85 0.85 0.85

19287 Placement of breast localization devices accessed through the skin with MRI guidance 2.55 3.02 3.02 2.55

19288 Placement of breast localization devices accessed through the skin with MRI guidance 1.28 1.51 1.51 1.28

43204 Injection of dilated esophageal veins using an endoscope 2.40 2.89 2.77 2.40

43205 Tying of esophageal veins using an endoscope 2.51 3.00 2.88 2.51 43213 Dilation of esophagus using an endoscope 4.73 5.00 5.00 4.73CMS-1612-FC 236

HCPCS

Code Descriptor CY 2014 Interim

Final Work RVU RUC Recommended

Work RVU Refinement Panel Median Rating CY 2015 Work RVU

43233 Balloon dilation of esophagus, stomach, and/or upper small bowel using an endoscope 4.05 4.45 4.26 4.26

43255 Control of bleeding of esophagus, stomach, and/or upper small bowel using an endoscope 3.66 4.20 4.20 3.66

(ii) Code-Specific Issues

For each code with an interim final work va lue, Table 15 lists the CY 2014 interim final

work RVU and the CY 2015 work RVU and indi cates whether we are finalizing the CY 2015 work RVU. For codes without a work RVU, the ta ble includes a PFS procedure status indicator. A list of the PFS procedure stat us indicators can be found in Addendum A. If the CY 2015

Action column indicates that the CY 2015 valu es are interim final, we will accept public comments on these values during th e public comment period for this final rule with comment period. A comprehensive list of all values fo r which public comments are being solicited is

contained in Addendum C to the CY 2015 PFS final rule with comment period. A comprehensive list of all CY 2015 RVUs is in Addendum B to this final rule with comment period. All Addenda to PFS final rule are av ailable on the CMS website under downloads at http://www.cms.gov/physician feesched /PFS Federal Regulation Notices.html/ . The time values

for all codes are listed in a file called “CY 2015 PFS Work Time,” available on the CMS website

under downloads for the CY 2015 PFS fi nal rule with comment period at http://www.cms.gov/physicianfeesched/downloads/

.CMS-1612-FC 237

TABLE 15: CY 2015 Actions on Code s with CY 2014 Interim Final RVUs

HCPCS

Code Long Descriptor CY 2014 Interim

Final Work RVU CY 2015 Work RVU CY 2015 Action

10030 Image-guided fluid collection drainage by catheter (eg, abscess, hematoma, seroma, lymphocele, cyst), soft tissue (eg, extremity, abdominal wall, neck), percutaneous 3.00 3.00 Finalize

17000 Destruction (eg, laser surgery, electrosurgery, cryosurgery, chemosurgery, surgical curett ement), premalignant lesions (eg, actinic keratoses); first lesion 0.61 0.61 Finalize

17003 Destruction (eg, laser surgery, electrosurgery, cryosurgery, chemosurgery, surgical curett ement), premalignant lesions (eg, actinic keratoses); second through 14 lesions, each (list separately in addition to code for first lesion) 0.04 0.04 Finalize

17004 Destruction (eg, laser surgery, electrosurgery, cryosurgery, chemosurgery, surgical curett ement), premalignant lesions (eg, actinic keratoses), 15 or more lesions 1.37 1.37 Finalize

17311 Mohs micrographic technique, including removal of all gross tumor, surgical excision of tissue specimens, mapping, color coding of specimens, microscopic examination of specimens by the surgeon, and histopathologic preparation incl uding routine stain(s) (eg, hematoxylin and eosin, toluidine blue), head, neck, hands, feet, genitalia, or any location with surgery directly involving muscle, cartilage, bone, tendon, major nerves, or vessels; first stage, up to 5 tissue blocks 6.20 6.20 Finalize

17312 Mohs micrographic technique, including removal of all gross tumor, surgical excision of tissue specimens, mapping, color coding of specimens, microscopic examination of specimens by the surgeon, and histopathologic preparation incl uding routine stain(s) (eg, hematoxylin and eosin, toluidine blue), head, neck, hands, feet, genitalia, or any location with surgery directly involving muscle, cartilage, bone, tendon, major nerves, or vessels; each additional stage after the first stage, up to 5 tissue blocks (list separately in addition to code for primary procedure) 3.30 3.30 Finalize

17313 Mohs micrographic technique, including removal of all gross tumor, surgical excision of tissue specimens, mapping, color coding of specimens, microscopic examination of specimens by the surgeon, and histopathologic preparation incl uding routine stain(s) (eg, hematoxylin and eosin, toluidine blue), of the trunk, arms, or legs; first stage, up to 5 tissue blocks 5.56 5.56 FinalizeCMS-1612-FC 238

HCPCS

Code Long Descriptor CY 2014 Interim

Final Work RVU CY 2015 Work RVU CY 2015 Action

17314 Mohs micrographic technique, including removal of all gross tumor, surgical excision of tissue specimens, mapping, color coding of specimens, microscopic examination of specimens by the surgeon, and histopathologic preparation incl uding routine stain(s) (eg, hematoxylin and eosin, toluidine blue), of the trunk, arms, or legs; each additional stage after the first stage, up to 5 tissue blocks (list separately in addition to code for primary procedure) 3.06 3.06 Finalize

17315 Mohs micrographic technique, including removal of all gross tumor, surgical excision of tissue specimens, mapping, color coding of specimens, microscopic examination of specimens by the surgeon, and histopathologic preparation incl uding routine stain(s) (eg, hematoxylin and eosin, toluidine blue), each additional block after the first 5 tissue blocks, any stage (list separately in addition to code for primary procedure) 0.87 0.87 Finalize

19081 Biopsy, breast, with placem ent of breast localization device(s) (eg, clip, metallic pellet), when performed, and imaging of the biopsy specimen, when performed, percutaneous; first lesion, including stereotactic guidance 3.29 3.29 Finalize

19082 Biopsy, breast, with placem ent of breast localization device(s) (eg, clip, metallic pellet), when performed, and imaging of the biopsy specimen, when performed, percutaneous; each additional le sion, including stereotactic guidance (list separately in addition to code for primary procedure) 1.65 1.65 Finalize

19083 Biopsy, breast, with placem ent of breast localization device(s) (eg, clip, metallic pellet), when performed, and imaging of the biopsy specimen, when performed, percutaneous; first lesion, including ultrasound guidance 3.10 3.10 Finalize

19084 Biopsy, breast, with placem ent of breast localization device(s) (eg, clip, metallic pellet), when performed, and imaging of the biopsy specimen, when performed, percutaneous; each additional le sion, including ultrasound guidance (list separately in addition to code for primary procedure) 1.55 1.55 Finalize

19085 Biopsy, breast, with placem ent of breast localization device(s) (eg, clip, metallic pellet), when performed, and imaging of the biopsy specimen, when performed, percutaneous; first lesion, including magnetic resonance guidance 3.64 3.64 Finalize

19086 Biopsy, breast, with placem ent of breast localization device(s) (eg, clip, metallic pellet), when performed, and imaging of the biopsy specimen, when performed, percutaneous; each additional lesion, including magnetic resonance guidance (list separately in addition to code for primary procedure) 1.82 1.82 FinalizeCMS-1612-FC 239

HCPCS

Code Long Descriptor CY 2014 Interim

Final Work RVU CY 2015 Work RVU CY 2015 Action

19281 Placement of breast localization device(s) (eg, clip, metallic pellet, wire/needle, radioactive seeds), percutaneous; first lesion, including mammographic guidance 2.00 2.00 Finalize

19282 Placement of breast localization device(s) (eg, clip, metallic pellet, wire/needle, radioactive seeds), percutaneous; each additional lesion, including mammographic guidance (list separately in addition to code for primary procedure) 1.00 1.00 Finalize

19283 Placement of breast localization device(s) (eg, clip, metallic pellet, wire/needle, radioactive seeds), percutaneous; first lesion, including stereotactic guidance 2.00 2.00 Finalize

19284 Placement of breast localization device(s) (eg, clip, metallic pellet, wire/needle, radioactive seeds), percutaneous; each additional le sion, including stereotactic guidance (list separately in addition to code for primary procedure) 1.00 1.00 Finalize

19285 Placement of breast localization device(s) (eg, clip, metallic pellet, wire/needle, radioactive seeds), percutaneous; first lesion, including ultrasound guidance 1.70 1.70 Finalize

19286 Placement of breast localization device(s) (eg, clip, metallic pellet, wire/needle, radioactive seeds), percutaneous; each additional le sion, including ultrasound guidance (list separately in addition to code for primary procedure) 0.85 0.85 Finalize

19287 Placement of breast localization device(s) (eg clip, metallic pellet, wire/needle, radioactive seeds), percutaneous; first lesion, including magnetic resonance guidance 2.55 2.55 Finalize

19288 Placement of breast localization device(s) (eg clip, metallic pellet, wire/needle, radioactive seeds), percutaneous; each additional lesion, including magnetic resonance guidance (list separately in addition to code for primary procedure) 1.28 1.28 Finalize

23333 Removal of foreign body, shoulder; deep (subfascial or intramuscular) 6.00 6.00 Finalize

23334 Removal of prosthesis, includes debridement and synovectomy when performed; humeral or glenoid component 15.50 15.50 Finalize

23335 Removal of prosthesis, includes debridement and synovectomy when performed; humeral and glenoid components (eg, total shoulder) 19.00 19.00 Finalize

23600 Closed treatment of proximal humeral (surgical or anatomical neck) fractur e; without manipulation 3.00 3.00 FinalizeCMS-1612-FC 240

HCPCS

Code Long Descriptor CY 2014 Interim

Final Work RVU CY 2015 Work RVU CY 2015 Action

24160 Removal of prosthesis, includes debridement and synovectomy when performed; humeral and ulnar components 18.63 18.63 Finalize

24164 Removal of prosthesis, includes debridement and synovectomy when performed; radial head 10.00 10.00 Finalize

27130 Arthroplasty, aceta bular and proximal femoral prosthetic replacement (total hip arthro plasty), with or without autograft or allograft 20.72 20.72 Finalize

27236 Open treatment of femoral fracture, proximal end, neck, internal fixation or prosthetic replacement 17.61 17.61 Finalize

27446 Arthroplasty, knee, condyle an d plateau; medial or lateral compartment 17.48 17.48 Finalize

27447 Arthroplasty, knee, condyle an d plateau; medial and lateral compartments with or without patella resurfacing (total knee arthroplasty) 20.72 20.72 Finalize

28470 Closed treatment of metatarsal fracture; without manipulation, each 2.03 2.03 Finalize 29075 Application, cast; elbow to finger (short arm) 0.77 0.77 Finalize

29581 Application of multi-layer compression system; leg (below knee), including ankle and foot 0.25 0.25 Finalize

29582 Application of multi-layer compression system; thigh and leg, including ankle and foot, when performed 0.35 0.35 Finalize

29583 Application of multi-layer compression system; upper arm and forearm 0.25 0.25 Finalize

29584 Application of multi-layer compression system; upper arm, forearm, hand, and fingers 0.35 0.35 Finalize

29824 Arthroscopy, shoulder, surgi cal; distal claviculectomy including distal articular surface (mumford procedure) 8.98 8.98 Finalize

29826 Arthroscopy, shoulder, surgical; decompression of subacromial space with par tial acromioplasty, with coracoacromial ligament (ie, arch) release, when performed (list separately in addition to code for primary procedure) 3.00 3.00 Finalize

31237 Nasal/sinus endoscopy, surgical; with biopsy, polypectomy or debridement (separate procedure) 2.60 2.60 Finalize

31238 Nasal/sinus endoscopy, surgical; with control of nasal hemorrhage 2.74 2.74 Finalize

31239 Nasal/sinus endoscopy, surgical; with dacryocystorhinostomy 9.04 9.04 Finalize

31240 Nasal/sinus endoscopy, surgical; with concha bullosa resection 2.61 2.61 Finalize 33282 Implantation of patient-activated cardiac event recorder 3.50 3.50 FinalizeCMS-1612-FC 241

HCPCS

Code Long Descriptor CY 2014 Interim

Final Work RVU CY 2015 Work RVU CY 2015 Action

33284 Removal of an implantable, pa tient-activated cardiac event recorder 3.00 3.00 Finalize

33366 Transcatheter aortic valve replacement (tavr/tavi) with prosthetic valve; transapical exposure (eg, left thoracotomy) 35.88 35.88 Finalize

34841 Endovascular repair of visceral aorta (eg, aneurysm, pseudoaneurysm, dissection, penetrating ulcer, intramural hematoma, or traumatic disruption) by deployment of a fenestrated visceral aortic endograft and all associated radiological supervision and interpretation, including target zone angioplasty, when performed; including one visceral artery endoprosthesi s (superior mesenteric, celiac or renal artery) C C Finalize

34842 Endovascular repair of visceral aorta (eg, aneurysm, pseudoaneurysm, dissection, penetrating ulcer, intramural hematoma, or traumatic disruption) by deployment of a fenestrated visceral aortic endograft and all associated radiological supervision and interpretation, including target zone angioplasty, when performed; including two visceral artery endoprosthese s (superior mesenteric, celiac and/or renal artery[s]) C C Finalize

34843 Endovascular repair of visceral aorta (eg, aneurysm, pseudoaneurysm, dissection, penetrating ulcer, intramural hematoma, or traumatic disruption) by deployment of a fenestrated visceral aortic endograft and all associated radiological supervision and interpretation, including target zone angioplasty, when performed; including three visceral artery endoprosthese s (superior mesenteric, celiac and/or renal artery[s]) C C Finalize

34844 Endovascular repair of visceral aorta (eg, aneurysm, pseudoaneurysm, dissection, penetrating ulcer, intramural hematoma, or traumatic disruption) by deployment of a fenestrated visceral aortic endograft and all associated radiological supervision and interpretation, including target zone angioplasty, when performed; including four or more visceral artery endopros theses (superior mesenteric, celiac and/or renal artery[s]) C C Finalize

34845 Endovascular repair of visceral aorta and infrarenal abdominal aorta (eg, aneurysm, pseudoaneurysm, dissection, penetrating ulcer, intramural hematoma, or traumatic disruption) with a fenestrated visceral aortic endograft and concomitant unibody or modular infrarenal aortic endograft and all associ ated radiological supervision and interpretation, including target zone angioplasty, when performed; including one visc eral artery endoprosthesis (superior mesenteric, celiac or renal artery) C C FinalizeCMS-1612-FC 242

HCPCS

Code Long Descriptor CY 2014 Interim

Final Work RVU CY 2015 Work RVU CY 2015 Action

34846 Endovascular repair of visceral aorta and infrarenal abdominal aorta (eg, aneurysm, pseudoaneurysm, dissection, penetrating ulcer, intramural hematoma, or traumatic disruption) with a fenestrated visceral aortic endograft and concomitant unibody or modular infrarenal aortic endograft and all associ ated radiological supervision and interpretation, including target zone angioplasty, when performed; including two vis ceral artery endoprostheses (superior mesenteric, celiac and/or renal artery[s]) C C Finalize

34847 Endovascular repair of visceral aorta and infrarenal abdominal aorta (eg, aneurysm, pseudoaneurysm, dissection, penetrating ulcer, intramural hematoma, or traumatic disruption) with a fenestrated visceral aortic endograft and concomitant unibody or modular infrarenal aortic endograft and all associ ated radiological supervision and interpretation, including target zone angioplasty, when performed; including three visceral artery endoprostheses (superior mesenteric, celiac and/or renal artery[s]) C C Finalize

34848 Endovascular repair of visceral aorta and infrarenal abdominal aorta (eg, aneurysm, pseudoaneurysm, dissection, penetrating ulcer, intramural hematoma, or traumatic disruption) with a fenestrated visceral aortic endograft and concomitant unibody or modular infrarenal aortic endograft and all associ ated radiological supervision and interpretation, including target zone angioplasty, when performed; including four or more visceral artery endoprostheses (superior mesenteric, celiac and/or renal artery[s]) C C Finalize

35301 Thromboendarterectomy, including patch graft, if performed; carotid, vertebral, subclavian, by neck incision 21.16 21.16 Finalize

36245 Selective catheter placement, arterial system; each first order abdominal, pelvic, or lower extremity artery branch, within a vascular family 4.90 4.90 Finalize

37217 Transcatheter placement of intravascular stent(s), intrathoracic common carotid ar tery or innominate artery by retrograde treatment, open ipsilateral cervical carotid artery exposure, including angioplasty, when performed, and radiological supervision and interpretation 20.38 20.38 Finalize

37236 Transcatheter placement of an intravascular stent(s) (except lower extremity artery(s) for occlusive disease, cervical carotid, extracranial vertebral or intrathoracic carotid, intracranial, or corona ry), open or percutaneous, including radiological supervision and interpretation and including all angioplasty within the same vessel, when performed; initial artery 9.00 9.00 FinalizeCMS-1612-FC 243

HCPCS

Code Long Descriptor CY 2014 Interim

Final Work RVU CY 2015 Work RVU CY 2015 Action

37237 Transcatheter placement of an intravascular stent(s) (except lower extremity artery(s) for occlusive disease, cervical carotid, extracranial vertebral or intrathoracic carotid, intracranial, or corona ry), open or percutaneous, including radiological supervision and interpretation and including all angioplasty within the same vessel, when performed; each additional artery (list separately in addition to code for primary procedure) 4.25 4.25 Finalize

37238 Transcatheter placement of an intravascular stent(s), open or percutaneous, including radiological supervision and interpretation and including angioplasty within the same vessel, when performed; initial vein 6.29 6.29 Finalize

37239 Transcatheter placement of an intravascular stent(s), open or percutaneous, including radiological supervision and interpretation and including angioplasty within the same vessel, when performed; each additional vein (list separately in addition to code for primary procedure) 2.97 2.97 Finalize

37241 Vascular embolization or occlusion, inclusive of all radiological supervision and interpretation, intraprocedural roadmapping, and imaging guidance necessary to complete the intervention; venous, other than hemorrhage (eg, congenital or acquired venous malformations, venous and capillary hemangiomas, varices, varicoceles) 9.00 9.00 Finalize

37242 Vascular embolization or occlusion, inclusive of all radiological supervision and interpretation, intraprocedural roadmapping, and imaging guidance necessary to complete the intervention; arterial, other than hemorrhage or tumor (eg, congenital or acquired arterial malformations, arteriovenous malformations, arteriovenous fistulas, aneurysms, pseudoaneurysms) 10.05 10.05 Finalize

37243 Vascular embolization or occlusion, inclusive of all radiological supervision and interpretation, intraprocedural roadmapping, and imaging guidance necessary to complete the intervention; for tumors, organ ischemia, or infarction 11.99 11.99 Finalize

37244 Vascular embolization or occlusion, inclusive of all radiological supervision and interpretation, intraprocedural roadmapping, and imaging guidance necessary to complete the intervention; for arterial or venous hemorrhage or lymphatic extravasation 14.00 14.00 Finalize

43191 Esophagoscopy, rigid, transoral; diagnostic, including collection of specimen(s) by brushing or washing when performed (separate procedure) 2.00 2.49 Finalize

43192 Esophagoscopy, rigid, transoral; with directed submucosal injection(s), any substance 2.45 2.79 FinalizeCMS-1612-FC 244

HCPCS

Code Long Descriptor CY 2014 Interim

Final Work RVU CY 2015 Work RVU CY 2015 Action

43193 Esophagoscopy, rigid, transoral; with biopsy, single or multiple 3.00 2.79 Finalize

43194 Esophagoscopy, rigid, transoral; with removal of foreign body(s) 3.00 3.51 Finalize

43195 Esophagoscopy, rigid, transoral; with balloon dilation (less than 30 mm diameter) 3.00 3.07 Finalize

43196 Esophagoscopy, rigid, transoral; with insertion of guide wire followed by dilation over guide wire 3.30 3.31 Finalize

43197 Esophagoscopy, flexible, transnasal; diagnostic, including collection of specimen(s) by brushing or washing, when performed (separate procedure) 1.48 1.52 Finalize

43198 Esophagoscopy, flexible, transnasal; with biopsy, single or multiple 1.78 1.82 Finalize

43200 Esophagoscopy, flexible, transoral; diagnostic, including collection of specimen(s) by brushing or washing, when performed (separate procedure) 1.50 1.52 Finalize

43201 Esophagoscopy, flexible, transoral; with directed submucosal injection(s), any substance 1.80 1.82 Finalize

43202 Esophagoscopy, flexible, transoral; with biopsy, single or multiple 1.80 1.82 Finalize

43204 Esophagoscopy, flexible, transoral; with injection sclerosis of esophageal varices 2.40 2.43 Finalize

43205 Esophagoscopy, flexible, transoral; with band ligation of esophageal varices 2.51 2.54 Finalize

43206 Esophagoscopy, flexible, transoral; with optical endomicroscopy 2.39 2.39 Finalize

43211 Esophagoscopy, flexible, transoral; with endoscopic mucosal resection 4.21 4.30 Finalize

43212 Esophagoscopy, flexible, transoral; with placement of endoscopic stent (includes pre- and post-dilation and guide wire passage, when performed) 3.38 3.50 Finalize

43213 Esophagoscopy, flexible, transoral; with dilation of esophagus, by balloon or dilator, retrograde (includes fluoroscopic guidance, when performed) 4.73 4.73 Finalize

43214 Esophagoscopy, flexible, transoral; with dilation of esophagus with balloon (30 mm diameter or larger) (includes fluoroscopic guidance, when performed) 3.38 3.50 Finalize

43215 Esophagoscopy, flexible, transoral; with removal of foreign body(s) 2.51 2.54 Finalize

43216 Esophagoscopy, flexible, transoral; with removal of tumor(s), polyp(s), or other lesion(s) by hot biopsy forceps 2.40 2.40 Finalize

43217 Esophagoscopy, flexible, transoral; with removal of tumor(s), polyp(s), or other lesion(s) by snare technique 2.90 2.90 FinalizeCMS-1612-FC 245

HCPCS

Code Long Descriptor CY 2014 Interim

Final Work RVU CY 2015 Work RVU CY 2015 Action

43220 Esophagoscopy, flexible, transoral; with transendoscopic balloon dilation (less than 30 mm diameter) 2.10 2.10 Finalize

43226 Esophagoscopy, flexible, transo ral; with insertion of guide wire followed by passage of dilator(s) over guide wire 2.34 2.34 Finalize

43227 Esophagoscopy, flexible, transoral; with control of bleeding, any method 2.99 2.99 Finalize

43229 Esophagoscopy, flexible, transoral; with ablation of tumor(s), polyp(s), or other lesion(s) (includes pre- and post-dilation and guide wire passage, when performed) 3.54 3.59 Finalize

43231 Esophagoscopy, flexible, transoral; with endoscopic ultrasound examination 2.90 2.90 Finalize

43232 Esophagoscopy, flexible, transoral; with transendoscopic ultrasound-guided intramural or transmural fine needle aspiration/biopsy(s) 3.54 3.59 Finalize

43233 Esophagogastroduodenoscopy, flexible, transoral; with dilation of esophagus with balloon (30 mm diameter or larger) (includes fluoroscopic guidance, when performed) 4.05 4.17 Finalize

43235 Esophagogastroduodenoscopy, flexible, transoral; diagnostic, including collection of specimen(s) by brushing or washing, when performed (separate procedure) 2.17 2.19 Finalize

43236 Esophagogastroduodenoscopy, flexible, transoral; with directed submucosal inj ection(s), any substance 2.47 2.49 Finalize

43237 Esophagogastroduodenoscopy, flexible, transoral; with endoscopic ultrasound examination limited to the esophagus, stomach or duodenum, and adjacent structures 3.57 3.57 Finalize

43238 Esophagogastroduodenoscopy, flexible, transoral; with transendoscopic ultrasound-guided intramural or transmural fine needle aspiration/biopsy(s), (includes endoscopic ultrasound examination limited to the esophagus, stomach or duodenum, and adjacent structures) 4.11 4.26 Finalize

43239 Esophagogastroduodenoscopy, flexible, transoral; with biopsy, single or multiple 2.47 2.49 Finalize

43240 Esophagogastroduodenoscopy, flexible, transoral; with transmural drainage of pseudocyst (includes placement of transmural drainage catheter[s]/stent[s], when performed, and endoscopic ultrasound, when performed) 7.25 7.25 Finalize

43241 Esophagogastroduodenoscopy, flexible, transoral; with insertion of intraluminal tube or catheter 2.59 2.59 FinalizeCMS-1612-FC 246

HCPCS

Code Long Descriptor CY 2014 Interim

Final Work RVU CY 2015 Work RVU CY 2015 Action

43242 Esophagogastroduodenoscopy, flexible, transoral; with transendoscopic ultrasound-guided intramural or transmural fine needle aspiration/biopsy(s) (includes endoscopic ultrasound examination of the esophagus, stomach, and either the duodenum or a surgically altered stomach where the jejunum is examined distal to the anastomosis) 4.68 4.83 Finalize

43243 Esophagogastroduodenoscopy, flexible, transoral; with injection sclerosis of esophageal/gastric varices 4.37 4.37 Finalize

43244 Esophagogastroduodenoscopy, flexible, transoral; with band ligation of esophageal/gastric varices 4.50 4.50 Finalize

43245 Esophagogastroduodenoscopy, flexible, transoral; with dilation of gastric/duodenal stricture(s) (eg, balloon, bougie) 3.18 3.18 Finalize

43246 Esophagogastroduodenoscopy, flexible, transoral; with directed placement of percutaneous gastrostomy tube 3.66 3.66 Finalize

43247 Esophagogastroduodenoscopy, flexible, transoral; with removal of foreign body(s) 3.18 3.21 Finalize

43248 Esophagogastroduodenoscopy, flexible, transoral; with insertion of guide wire followed by passage of dilator(s) through esophagus over guide wire 3.01 3.01 Finalize

43249 Esophagogastroduodenoscopy, flexible, transoral; with transendoscopic balloon dilation of esophagus (less than 30 mm diameter) 2.77 2.77 Finalize

43250 Esophagogastroduodenoscopy, flexible, transoral; with removal of tumor(s), polyp(s), or other lesion(s) by hot biopsy forceps 3.07 3.07 Finalize

43251 Esophagogastroduodenoscopy, flexible, transoral; with removal of tumor(s), polyp(s), or other lesion(s) by snare technique 3.57 3.57 Finalize

43252 Esophagogastroduodenoscopy, flexible, transoral; with optical endomicroscopy 3.06 3.06 Finalize

43253 Esophagogastroduodenoscopy, flexible, transoral; with transendoscopic ultrasound-guided transmural injection of diagnostic or therapeutic s ubstance(s) (eg, anesthetic, neurolytic agent) or fiducial marker(s) (includes endoscopic ultrasound examination of the esophagus, stomach, and either the duodenum or a surgically altered stomach where the jejunum is examined distal to the anastomosis) 4.68 4.83 Finalize

43254 Esophagogastroduodenoscopy, flexible, transoral; with endoscopic mucosal resection 4.88 4.97 Finalize

43255 Esophagogastroduodenoscopy, flexible, transoral; with control of bleeding, any method 3.66 3.66 FinalizeCMS-1612-FC 247

HCPCS

Code Long Descriptor CY 2014 Interim

Final Work RVU CY 2015 Work RVU CY 2015 Action

43257 Esophagogastroduodenoscopy, flexible, transoral; with delivery of thermal energy to the muscle of lower esophageal sphincter and/or gastric cardia, for treatment of gastroesophageal reflux disease 4.11 4.25 Finalize

43259 Esophagogastroduodenoscopy, flexible, transoral; with endoscopic ultrasound examination, including the esophagus, stomach, and either the duodenum or a surgically altered stomach wh ere the jejunum is examined distal to the anastomosis 4.14 4.14 Finalize

43260 Endoscopic retrograde cholangiopancreatography (ercp); diagnostic, including collection of specimen(s) by brushing or washing, when performed (separate procedure) 5.95 5.95 Finalize

43261 Endoscopic retrograde cholangiopancreatography (ercp); with biopsy, single or multiple 6.25 6.25 Finalize

43262 Endoscopic retrograde cholangiopancreatography (ercp); with sphincterotomy/papillotomy 6.60 6.60 Finalize

43263 Endoscopic retrograde cholangiopancreatography (ercp); with pressure measurement of sphincter of oddi 6.60 6.60 Finalize

43264 Endoscopic retrograde cholangiopancreatography (ercp); with removal of calculi/debris from biliary/pancreatic duct(s) 6.73 6.73 Finalize

43265 Endoscopic retrograde cholangiopancreatography (ercp); with destruction of calculi, any method (eg, mechanical, electrohydraulic, lithotripsy) 8.03 8.03 Finalize

43266 Esophagogastroduodenoscopy, flexible, transoral; with placement of endoscopic sten t (includes pre- and postdilation and guide wire passage, when performed) 4.05 4.17 Finalize

43270 Esophagogastroduodenoscopy, flexible, transoral; with ablation of tumor(s), polyp(s), or other lesion(s) (includes pre- and post-dilation and guide wire passage, when performed) 4.21 4.26 Finalize

43273 Endoscopic cannulation of papilla with direct visualization of pancreatic/common bile duct(s) (list separately in addition to code(s) for primary procedure) 2.24 2.24 Finalize

43274 Endoscopic retrograde cholangiopancreatography (ercp); with placement of endoscopi c stent into biliary or pancreatic duct, including pre- and post-dilation and guide wire passage, when performed, including sphincterotomy, when performed, each stent 8.48 8.58 Finalize

43275 Endoscopic retrograde cholangiopancreatography (ercp); with removal of foreign body(s) or stent(s) from biliary/pancreatic duct(s) 6.96 6.96 FinalizeCMS-1612-FC 248

HCPCS

Code Long Descriptor CY 2014 Interim

Final Work RVU CY 2015 Work RVU CY 2015 Action

43276 Endoscopic retrograde cholangiopancreatography (ercp); with removal and exchange of stent(s), biliary or pancreatic duct, including pre- and post-dilation and guide wire passage, when performed, including sphincterotomy, when performed, each stent exchanged 8.84 8.94 Finalize

43277 Endoscopic retrograde cholangiopancreatography (ercp); with trans-endoscopic balloon dilation of biliary/pancreatic duct(s) or of ampulla (sphincteroplasty), including sphincterotomy, wh en performed, each duct 7.00 7.00 Finalize

43278 Endoscopic retrograde cholangiopancreatography (ercp); with ablation of tumor(s), polyp(s), or other lesion(s), including pre- and post-dilation and guide wire passage, when performed 7.99 8.02 Finalize

43450 Dilation of esophagus, by unguided sound or bougie, single or multiple passes 1.38 1.38 Finalize 43453 Dilation of esophagus, over guide wire 1.51 1.51 Finalize

49405 Image-guided fluid collection drainage by catheter (eg, abscess, hematoma, seroma, lymphocele, cyst); visceral (eg, kidney, liver, spleen, lung/mediastinum), percutaneous 4.25 4.25 Finalize

49406 Image-guided fluid collection drainage by catheter (eg, abscess, hematoma, seroma, ly mphocele, cyst); peritoneal or retroperitoneal, percutaneous 4.25 4.25 Finalize

49407 Image-guided fluid collection drainage by catheter (eg, abscess, hematoma, seroma, ly mphocele, cyst); peritoneal or retroperitoneal, transv aginal or transrectal 4.50 4.50 Finalize

50360 Renal allotransplantation, im plantation of graft; without recipient nephrectomy 39.88 39.88 Finalize

52332 Cystourethroscopy, with insertion of indwelling ureteral stent (eg, gibbons or double-j type) 2.82 2.82 Finalize

52356 Cystourethroscopy, with ureteroscopy and/or pyeloscopy; with lithotripsy including insertion of indwelling ureteral stent (eg, gibbons or double-j type) 8.00 8.00 Finalize

62310 Injection(s), of diagnostic or therapeutic substance(s) (including anesthetic, antispasmodic, opioid, steroid, other solution), not including neurolytic substances, including needle or catheter placement, includes contrast for localization when performed, epidural or subarachnoid; cervical or thoracic 1.18 See II.G.3.a

62311 Injection(s), of diagnostic or therapeutic substance(s) (including anesthetic, antispasmodic, opioid, steroid, other solution), not including neurolytic substances, including needle or catheter placement, includes contrast for localization when performed, epidural or subarachnoid; lumbar or sacral (caudal) 1.17 See II.G.3.aCMS-1612-FC 249

HCPCS

Code Long Descriptor CY 2014 Interim

Final Work RVU CY 2015 Work RVU CY 2015 Action

62318 Injection(s), including in dwelling catheter placement, continuous infusion or intermittent bolus, of diagnostic or therapeutic substance(s) (including anesthetic, antispasmodic, opioid, steroid, other solution), not including neurolytic substances, includes contrast for localization when performed, epidural or subarachnoid; cervical or thoracic 1.54 See II.G.3.a

62319 Injection(s), including in dwelling catheter placement, continuous infusion or intermittent bolus, of diagnostic or therapeutic substance(s) (including anesthetic, antispasmodic, opioid, steroid, other solution), not including neurolytic substances, includes contrast for localization when performed, epidural or subarachnoid; lumbar or sacral (caudal) 1.50 See II.G.3.a

63047 Laminectomy, facetectomy a nd foraminotomy (unilateral or bilateral with decompression of spinal cord, cauda equina and/or nerve root[s], [eg, spinal or lateral recess stenosis]), single vertebral segment; lumbar 15.37 15.37 Finalize

63048 Laminectomy, facetectomy a nd foraminotomy (unilateral or bilateral with decompression of spinal cord, cauda equina and/or nerve root[s], [eg, spinal or lateral recess stenosis]), single vertebral segment; each additional segment, cervical, thoracic, or lumbar (list separately in addition to code for primary procedure) 3.47 3.47 Finalize

64616 Chemodenervation of muscle(s); neck muscle(s), excluding muscles of the larynx, unilateral (eg, for cervical dystonia, spasmodic torticollis) 1.53 1.53 Finalize

64617 Chemodenervation of muscle(s); larynx, unilateral, percutaneous (eg, for spasmodic dysphonia), includes guidance by needle electromyography, when performed 1.90 1.90 Finalize

64642 Chemodenervation of one extremity; 1-4 muscle(s) 1.65 1.65 Finalize

64643 Chemodenervation of one extremity; each additional extremity, 1-4 muscle(s) (list separately in addition to code for primary procedure) 1.22 1.22 Finalize

64644 Chemodenervation of one extremity; 5 or more muscles 1.82 1.82 Finalize

64645 Chemodenervation of one extremity; each additional extremity, 5 or more muscles (list separately in addition to code for primary procedure) 1.39 1.39 Finalize 64646 Chemodenervation of trunk muscle(s); 1-5 muscle(s) 1.80 1.80 Finalize 64647 Chemodenervation of trunk muscle(s); 6 or more muscles 2.11 2.11 Finalize

66183 Insertion of anterior segment aqueous drainage device, without extraocular reservoir, external approach 13.20 13.20 Finalize 67914 Repair of ectropion; suture 3.75 3.75 Finalize 67915 Repair of ectropion; thermocauterization 2.03 2.03 FinalizeCMS-1612-FC 250

HCPCS

Code Long Descriptor CY 2014 Interim

Final Work RVU CY 2015 Work RVU CY 2015 Action

67916 Repair of ectropion; excision tarsal wedge 5.48 5.48 Finalize 67917 Repair of ectropion; extensive (eg, tarsal strip operations) 5.93 5.93 Finalize 67921 Repair of entropion; suture 3.47 3.47 Finalize 67922 Repair of entropion; thermocauterization 2.03 2.03 Finalize 67923 Repair of entropion; excision tarsal wedge 5.48 5.48 Finalize

67924 Repair of entropion; extensive (eg, tarsal strip or capsulopalpebral fascia repairs operation) 5.93 5.93 Finalize

69210 Removal impacted cerumen requiring instrumentation, unilateral 0.61 0.61 Finalize

70450 Computed tomography, head or brain; without contrast material 0.85 0.85 Finalize

70460 Computed tomography, head or brain; with contrast material(s) 1.13 1.13 Finalize

70551 Magnetic resonance (eg, proton) imaging, brain (including brain stem); without contrast material 1.48 1.48 Finalize

70552 Magnetic resonance (eg, proton) imaging, brain (including brain stem); with contrast material(s) 1.78 1.78 Finalize

70553 Magnetic resonance (eg, proton) imaging, brain (including brain stem); without contrast material, followed by contrast material(s) and further sequences 2.29 2.29 Finalize

72141 Magnetic resonance (eg, proton) imaging, spinal canal and contents, cervical; without contrast material 1.48 1.48 Finalize

72142 Magnetic resonance (eg, proton) imaging, spinal canal and contents, cervical; with contrast material(s) 1.78 1.78 Finalize

72146 Magnetic resonance (eg, proton) imaging, spinal canal and contents, thoracic; without contrast material 1.48 1.48 Finalize

72147 Magnetic resonance (eg, proton) imaging, spinal canal and contents, thoracic; with contrast material(s) 1.78 1.78 Finalize

72148 Magnetic resonance (eg, proton) imaging, spinal canal and contents, lumbar; without contrast material 1.48 1.48 Finalize

72149 Magnetic resonance (eg, proton) imaging, spinal canal and contents, lumbar; with contrast material(s) 1.78 1.78 Finalize

72156 Magnetic resonance (eg, proton) imaging, spinal canal and contents, without contrast material, followed by contrast material(s) and further sequences; cervical 2.29 2.29 Finalize

72157 Magnetic resonance (eg, proton) imaging, spinal canal and contents, without contrast material, followed by contrast material(s) and further sequences; thoracic 2.29 2.29 Finalize

72158 Magnetic resonance (eg, proton) imaging, spinal canal and contents, without contrast material, followed by contrast material(s) and further sequences; lumbar 2.29 2.29 FinalizeCMS-1612-FC 251

HCPCS

Code Long Descriptor CY 2014 Interim

Final Work RVU CY 2015 Work RVU CY 2015 Action

72191 Computed tomographic angiography, pelvis, with contrast material(s), including noncon trast images, if performed, and image postprocessing 1.81 1.81 Finalize

75896- 26 Transcatheter therapy, infusion, other than for thrombolysis, radiological supervision and interpretation 1.31 1.31 Finalize

75896- TC Transcatheter therapy, infusion, other than for thrombolysis, radiological supervision and interpretation C C Finalize

75898- 26 Angiography through existing catheter for follow-up study for transcatheter therapy, embolization or infusion, other than for thrombolysis 1.65 1.65 Finalize

75898- TC Angiography through existing catheter for follow-up study for transcatheter therapy, embolization or infusion, other than for thrombolysis C C Finalize

77001 Fluoroscopic guidance for central venous access device placement, replacement (catheter only or complete), or removal (includes fluoroscopic guidance for vascular access and catheter manipulation, any necessary contrast injections through access site or catheter with related venography radiologic supervision and interpretation, and radiographic documentation of final catheter position) (list separately in addition to code for primary procedure) 0.38 0.38 Finalize

77002 Fluoroscopic guidance for ne edle placement (eg, biopsy, aspiration, injection, localization device) 0.54 0.54 Finalize

77003 Fluoroscopic guidance and localization of needle or catheter tip for spine or paraspinous diagnostic or therapeutic injection procedures (epidural or subarachnoid) 0.60 0.60 Finalize

77280 Therapeutic radiology simulation-aided field setting; simple 0.70 0.70 Finalize

77285 Therapeutic radiology simulation-aided field setting; intermediate 1.05 1.05 Finalize

77290 Therapeutic radiology simulation-aided field setting; complex 1.56 1.56 Finalize

77293 Respiratory motion management simulation (list separately in addition to code for primary procedure) 2.00 2.00 Finalize

77295 3-dimensional radiotherapy plan, including dose-volume histograms 4.29 4.29 Finalize

81161 Dmd (dystrophin) (eg, duchenne/becker muscular dystrophy) deletion analysis, and duplication analysis, if performed X X Finalize

88112 Cytopathology, selective ce llular enhancement technique with interpretation (eg, liquid based slide preparation method), except cervical or vaginal 0.56 0.56 Finalize

88120 Cytopathology, in situ hybridization (eg, fish), urinary tract specimen with morphometric analysis, 3-5 molecular probes, each specimen; manual 1.20 1.20 FinalizeCMS-1612-FC 252

HCPCS

Code Long Descriptor CY 2014 Interim

Final Work RVU CY 2015 Work RVU CY 2015 Action

88121 Cytopathology, in situ hybridization (eg, fish), urinary tract specimen with morphometric analysis, 3-5 molecular probes, each specimen; using computer-assisted technology 1.00 1.00 Finalize

88342 Immunohistochemistry or immunocytochemistry, per specimen; initial single antibody stain procedure I See II.G.3.b

88343 Immunohistochemistry or immunocytochemistry, each separately identifiable antibody per block, cytologic preparation, or hematologic smear; each additional separately identifiable antibody per slide (list separately in addition to code for primary procedure) I See II.G.3.b

88365 In situ hybridization (eg, fish), per specimen; initial single probe stain procedure 1.20 See II.G.3.b

88367 Morphometric analysis, in situ hybridization (quantitative or semi-quantitative), using computer-assisted technology, per specimen; initial single probe stain procedure 1.30 See II. G.3.b

88368 Morphometric analysis, in situ hybridization (quantitative or semi-quantitative), manual, per specimen; initial single probe stain procedure 1.40 See II.G3.b

88375 Optical endomicroscopic im age(s), interpretation and report, real-time or referred, each endoscopic session I 0.91 Finalize

90785 Interactive complexity (list separately in addition to the code for primary procedure) 0.33 0.33 Finalize 90791 Psychiatric diagnostic evaluation 3.00 3.00 Finalize 90792 Psychiatric diagnostic evaluation with medical services 3.25 3.25 Finalize 90832 Psychotherapy, 30 minutes with patient and/or family member 1.50 1.50 Finalize

90833 Psychotherapy, 30 minutes with patient and/or family member when performed with an evaluation and management service (list separately in addition to the code for primary procedure) 1.50 1.50 Finalize

90834 Psychotherapy, 45 minutes with patient and/or family member 2.00 2.00 Finalize

90836 Psychotherapy, 45 minutes with patient and/or family member when performed with an evaluation and management service (list separately in addition to the code for primary procedure) 1.90 1.90 Finalize

90837 Psychotherapy, 60 minutes with patient and/or family member 3.00 3.00 Finalize

90838 Psychotherapy, 60 minutes with patient and/or family member when performed with an evaluation and management service (list separately in addition to the code for primary procedure) 2.50 2.50 Finalize

90839 Psychotherapy for crisis; first 60 minutes 3.13 3.13 FinalizeCMS-1612-FC 253

HCPCS

Code Long Descriptor CY 2014 Interim

Final Work RVU CY 2015 Work RVU CY 2015 Action

90840 Psychotherapy for crisis; each additional 30 minutes (list separately in addition to code for primary service) 1.50 1.50 Finalize 90845 Psychoanalysis 2.10 2.10 Finalize 90846 Family psychotherapy (without the patient present) 2.40 2.40 Finalize 90847 Family psychotherapy (conjo int psychotherapy) (with patient present) 2.50 2.50 Finalize

90853 Group psychotherapy (other than of a multiple-family group) 0.59 0.59 Finalize

90863 Pharmacologic management, including prescription and review of medication, when performed with psychotherapy services (list separately in addition to the code for primary procedure) I I Finalize

92521 Evaluation of speech fluency (eg, st uttering, cluttering) 1.75 1.75 Finalize

92522 Evaluation of speech sound pr oduction (eg, articulation, phonological process, apraxia, dysarthria); 1.50 1.50 Finalize

92523 Evaluation of speech sound pr oduction (eg, articulation, phonological process, apraxia, dysarthria); with evaluation of language comprehension and expression (eg, receptive and expressive language) 3.00 3.00 Finalize

92524 Behavioral and qualitative analysis of voice and resonance 1.50 1.50 Finalize

93000 Electrocardiogram, routine ecg with at least 12 leads; with interpretation and report 0.17 0.17 Finalize

93010 Electrocardiogram, routine ecg with at least 12 leads; interpretation and report only 0.17 0.17 Finalize

93582 Percutaneous transcatheter closure of patent ductus arteriosus 12.56 12.56 Finalize

93583 Percutaneous transcatheter septal reduction therapy (eg, alcohol septal ablation) in cluding temporary pacemaker insertion when performed 14.00 14.00 Finalize

93880 Duplex scan of extracranial arteries; complete bilateral study 0.60 See II.G.3.b

93882 Duplex scan of extracranial arteries; unilateral or limited study 0.40 See II.G.3.b

95816 Electroencephalogram (eeg); including recording awake and drowsy 1.08 1.08 Finalize

95819 Electroencephalogram (eeg); including recording awake and asleep 1.08 1.08 Finalize

95822 Electroencephalogram (eeg); r ecording in coma or sleep only 1.08 1.08 Finalize

95928 Central motor evoked potential study (transcranial motor stimulation); upper limbs 1.50 1.50 Finalize

95929 Central motor evoked potential study (transcranial motor stimulation); lower limbs 1.50 1.50 FinalizeCMS-1612-FC 254

HCPCS

Code Long Descriptor CY 2014 Interim

Final Work RVU CY 2015 Work RVU CY 2015 Action

96365 Intravenous infusion, for therapy, prophylaxis, or diagnosis (specify substance or drug); initial, up to 1 hour 0.21 0.21 Finalize

96366 Intravenous infusion, for therapy, prophylaxis, or diagnosis (specify substance or drug); each additional hour (list separately in addition to code for primary procedure) 0.18 0.18 Finalize

96367 Intravenous infusion, for therapy, prophylaxis, or diagnosis (specify substance or drug); additional sequential infusion of a new drug/substance, up to 1 hour (list separately in addition to code for primary procedure) 0.19 0.19 Finalize

96368 Intravenous infusion, for therapy, prophylaxis, or diagnosis (specify substance or drug); concurrent infusion (list separately in addition to code for primary procedure) 0.17 0.17 Finalize

96413 Chemotherapy administration, intravenous infusion technique; up to 1 hour, single or initial substance/drug 0.28 0.28 Finalize

96415 Chemotherapy administration, intravenous infusion technique; each additional hour (list separately in addition to code for primary procedure) 0.19 0.19 Finalize

96417 Chemotherapy administration, intravenous infusion technique; each additional seque ntial infusion (different substance/drug), up to 1 hour (list separately in addition to code for primary procedure) 0.21 0.21 Finalize

97610 Low frequency, non-contact, non-thermal ultrasound, including topical application(s), when performed, wound assessment, and instruction(s) for ongoing care, per day C C Finalize

98940 Chiropractic manipulative treatment (cmt); spinal, 1-2 regions 0.46 0.46 Finalize

98941 Chiropractic manipulative treatment (cmt); spinal, 3-4 regions 0.71 0.71 Finalize

98942 Chiropractic manipulative treatment (cmt); spinal, 5 regions 0.96 0.96 Finalize

99446 Interprofessional telephone/internet assessment and management service provided by a consultative physician including a verbal and written report to the patient's treating/requesting physician or other qualified health care professional; 5-10 minutes of medical consultative discussion and review B B Finalize

99447 Interprofessional telephone/internet assessment and management service provided by a consultative physician including a verbal and written report to the patient's treating/requesting physician or other qualified health care professional; 11-20 minutes of medical consultative discussion and review B B Finalize

99448 Interprofessional telephone/internet assessment and management service provided by a consultative physician including a verbal and written report to the patient's treating/requesting physician or other qualified health care professional; 21-30 minutes of medical consultative discussion and review B B FinalizeCMS-1612-FC 255

HCPCS

Code Long Descriptor CY 2014 Interim

Final Work RVU CY 2015 Work RVU CY 2015 Action

99449 Interprofessional telephone/internet assessment and management service provided by a consultative physician including a verbal and written report to the patient's treating/requesting physician or other qualified health care professional; 31 minutes or more of medical consultative discussion and review B B Finalize

99481 Reduce temperature of total body in a critically ill neonate, per day C Deleted

99482 Reduce temperature of head in a critically ill neonate, per day C Deleted

G0461 Immunohistochemistry or immunocytochemistry, per specimen; first single or multiplex antibody stain 0.60 Deleted

G0462 Immunohistochemistry or immunocytochemistry, per specimen; each additional si ngle or multiplex antibody stain (list separately in addition to code for primary procedure) 0.24 Deleted

In the following section, we discuss each code for which we received a comment on the

CY 2014 interim final work value or work time during the comment period for the CY 2014 final rule with comment period or for which we ar e modifying the CY 2014 interim final work RVU, work time or procedure status indicator for CY 2015. If a code in Table 15 is not discussed in this section, we did not receive any comments on that code and are finalizing the interim final

work RVU and time without modification for CY 2015. (1) Mohs Surgery (CPT codes 17311 and 17313)

As detailed in the CY 2014 PFS final rule wi th comment period, we maintained the CY 2013 work RVUs for CPT codes 17311 and 17313 codes, based upon the RUC-recommended

work RVUs. Comment: We received a comment that was sup portive of the interim final work RVU. Response: We thank the commenter for their support and are finalizing the CY 2014

interim final values for CY 2015.CMS-1612-FC 256 (2) Breast Biopsy (CPT codes 19081, 19082, 19083, 19084, 19085, 19086, 19281, 19282, 19283, 19284, 19285, 19286, 19287, and 19288) For CY 2014, the CPT Editorial Panel created 14 new codes, CPT codes 19081 through 19288, to describe breast biopsy and placement of breast localization devices, and the RUC recommended work RVUs for each of these codes. In the 2014 final rule with comment period,

we established interim final values for all of these codes as recommended by the RUC except for CPT code 19287 and its add-on CPT code, 19288, whic h are used for magnetic resonance (MR) guidance. We expressed concern that for CPT code 19287 the RUC-recommended work RVUs were too high in relation to those of other ma rker placement codes, and refined it to a lower value. Since we had adopted the RUC recommenda tion that all the add-on codes in this family have work RVUs equal to 50 percent of the base code’s work RVU, our refinement of CPT code

19287 resulted in a refinement of CPT code 19288 al so. We also change d the intraservice time of CPT code 19286, an add-on code, from 19 mi nutes to 15 minutes since we believed the

intraservice time of an add-on code should not be higher than its ba se code and the base code for CPT code 19286, has an intraser vice time of 15 minutes. Comment: Several commenters disagreed w ith the new CPT coding structure for breast biopsy and placement of breast localization devices because, unlike the predec essor structure, it fails to distinguish between the two types of biop sy devices - standard core needle and vacuum assisted. One commenter suggested that the payment should be higher when services are vacuum assisted, and suggested that CMS create a modifier to report when these services are furnished using a vacuum assisted biopsy or create a series of G-codes th at distinguish between standard core needle biopsy and vacuum assisted biopsy. Response: We prefer to use the CPT c oding structure unless a programmatic need suggests that an alternative coding structure is pr eferable. In this case, we believe that we canCMS-1612-FC 257 pay appropriately for these services using the new CPT coding structure. To the extent that the commenters think the CPT coding system is not ideal for these services, we believe the CPT Editorial Panel is the appropriate forum for this concern. The commenters are mistaken regarding how the inputs for these codes were determined as they are based upon the typical service being vacuum assisted. Comment: Several commenters disagreed with the interim final work RVUs we established for CPT codes 19287 and 19288, stati ng that the higher RUC-recommended RVUs were more appropriate and would maintain relativity within the family. The commenters stated that these services have longe r intraservice time than other codes in the marker placement family, are of high intensity, produce high pa tient and family anxiety, and have higher malpractice costs. One commenter requested th at the entire breast biopsy code family be

referred to refinement. Other co mmenters requested refinement pa nel review of selected codes within this family. Response: Based upon this re quest, we referred this fam ily of codes to the CY 2014 multi-specialty refinement panel for further review. Prior to CY 2014, breast biopsies and marker placements were billed using a single co de. In addition, the appropriate image guidance code was separately billed. Prior to CY 2014, there were individual guidance codes for the different types of guidance including MR and stereotactic guidance. For CY 2013, the MR guidance code, CPT code 77032, had a lower work RVU than the stereotactic guidance code, CPT code 77031. Combin ing the values for the marker placement or biopsy codes with the guidance codes should not, in our view, result in a ch ange in the rank order of the guidance. Accordingly, we do not beli eve the bundled code that includes MR guidance should now be valued significantly higher than one th at includes the stereot actic guidance. Also, the refinement panel discussions did not provide new clinical information. Therefore, weCMS-1612-FC 258

continue to believe the CY 2014 interim final values are appropriate for CPT codes 19287 and 19288, and are finalizing them for CY 2015.

Comment: Commenters stated that the RUC-recommended intraservice time of 19 minutes for CPT code 19286, which is an add-on code, was incorrect and that the code should

have the same intraservice time as its base code (15 minutes) rather than the 14 minutes assigned by CMS. The commenter said that this was consistent with the ot her base code/add-on relationships across the family. Response: We agree and are finalizing th e intraservice time for CPT code 19286 at 15

minutes. Comment: In response to our request for confirmation that a post procedure mammogram is typically furnished with a brea st marker placement procedure, commenters agreed that it was. However, th ey disagreed with our assertion th at if it was typical it should be bundled with the appropriate brea st marker procedures. Commente rs said that it should be a separately reportable service because it requires additional work not captured by the codes in this family. Response: We thank commenters for their f eedback. We are not bundling post procedure mammograms with the appropriate breast marker code s at this time, but will consider whether as a services that typically occur together they should be bundled. (3) Hip and Knee Replacement (CPT Codes 27130, 27446 and 27447) In the CY 2014 final rule with comment period we established interim final values for three CPT codes for hip and knee replacements that had previously been identified as potentially misvalued codes under the CMS high expenditure procedural code screen. For CY 2014, we

established the RUC-recommended work value of 17.48 as interim final work RVUs for CPT code 27446. As we explained in the CY 2014 fina l rule with comment period, we establishedCMS-1612-FC 259

interim final work RVUs for CPT codes 27130 and 27447 that varied from those recommended by the RUC based upon information that we received from the relevant specialty societies. We noted that the information presented by the spec ialty societies and the RUC raised concerns regarding the appropriate valuation of these services, especially rela ted to the use of the best data source for determining the intraservice time invol ved in furnishing PFS services. Specifically, there was significant variation between the time va lues estimated through a survey versus those collected through specialty databa ses. We characterized our c oncerns saying, “The divergent recommendations from the specialty societie s and the RUC regarding the accuracy of the estimates of time for these services, including both the source of time estimates for the procedure itself as well as the inpatient a nd outpatient visits incl uded in the global periods for these codes, lead us to take a cautious approach in valuing these services.” With regard to the specific valuations, we agreed with the RUC’s recommendation to value CPT codes 27130 and 27447 equally. We explained that we modified the RUCrecommended work RVUs for these two codes to reflect the visits in the global period as recommended by the specialty societies, resu lting in a 1.12 work RVU increase from the RUCrecommended value for each code. Accordi ngly, we assigned CPT codes 27130 and 27447 an interim final work RVU of 20.72. We sought public comment regarding, not only the appropriate work RVUs for these services, but al so the most appropriate reconciliation for the conflicting information regarding time values fo r these services as presented to us by the physician community. We also sought public co mment on the use of specialty databases as compared to surveys for determining time values , potential sources of objective data regarding procedure times, and levels of visits furnis hed during the global periods for the services described by these codes.CMS-1612-FC 260

Comment: The RUC submitted comment s explaining how it reached its

recommendations for these codes and that it follow ed its process consistently in developing its

recommendations on these codes. All those w ho commented specifically on the interim final work RVUs for these codes objected to the inte rim final work RVUs - some citing potential access problems. Commenters suggested that we use more reliable time data. Commenters suggested that valuation should be based on actual time data, whic h demonstrates that the time for this code has not changed since the last valuation; and thus the work RVUs should not decrease from the CY 2013 values. Among the co mmenters’ suggestions were using data from the Function and Outcomes Research for Compar ative Effectiveness in Total Joint Replacement (FORCE-TJR), which includes data on more than 15,000 total lower extremity joint arthroplasty procedures, including time in/time out data for at least half of the procedures, and working with the specialty societies to expl ore the best data collection me thods. A commenter suggested restoring the CY 2013 work RVUs until additional time data are available. Another commenter suggested valuing these services utilizing a reverse building block me thodology resulting in

work RVU of 21.18 for CPT codes 27130 and 22.11 for CPT code 27447. A commenter stated that the hip and knee replacement codes should be valued differently since they are clinically different procedures. Two commen ters expressed concern regardi ng the use of a final rule to

establish interim values for establ ished hip and knee procedures due to the lack of opportunity it provides stakeholders to anal yze and comment on reductions prior to implementation. Response: In the CY 2014 final rule with comment period, we noted concerns about the time data used in valuing thes e services and requested additi onal input from stakeholders regarding using other sour ces of data beyond the surveys typically used by the RUC. We do not

believe that we received the kind of information and the level of detail about the other types of data suggested by commenters that we would ne ed to be able to us e routinely in valuingCMS-1612-FC 261 procedures. We will continue to explore the use of other data on time. As we discuss in section II.B. we have engaged contractors to assist us in exploring alte rnative data sources to use in determining the times associated with particular se rvices. At this time, we are not convinced that

data from another source would result in an improved value for these services. Nor did we find the reasons given for modifying the interim fi nal work values established in CY 2014. The interim final values are based upon the best data we have available a nd preserve appropriate relativity with other codes. Accordingly, we are finalizing the interim final values for these procedures. (4) Transcatheter Placement Intravas cular Stent (CPT Code 37236, 37237, 37238, and 37239) For CY 2014, we established the RUC-reco mmended work RVUs for newly created CPT codes 37236, 37237, and 37238 as the interim final values. We disagreed with the RUCrecommended work RVU for CPT code 37239, which is the add-on code to CPT code 37238, for the placement of an intravascular stent in each additional vein. As we described in the CY 2014 final rule with comment period we believe that th e work for placement of an additional stent in a vein should bear the same relationship to the work of placing an initial st ent in the vein as the placement of an additional stent in an artery to the placement of the initial stent in an artery.

Comment: Many commenters indicated th at our valuation of CPT code 37239 was inappropriate. They indicated that instead we should use th e RUC’s recommended work RVU of 3.34 for this code since the procedure is more intense and requires more physician work than would result from the comparison made by CMS. One commenter requested that CPT code 37239 be referred to the refinement panel. Response: After re-review, we continue to believe that the ratio of the work of the placement of the initial stent to the placement of additional stents is the same whether the stentsCMS-1612-FC 262 are placed in an artery or a vein, and accord ingly the appropriate ratio is found in the RUCrecommended work RVUs of CPT codes 37236 and 37237, the comparable codes for the arteries. For that reason, we ar e finalizing our CY 2014 interim final values. Additionally, we did not refer these codes for refinement panel re view because the criteria for refinement panel

review were not met. (5) Embolization and Occlusion Pr ocedures (CPT codes 37242 and 37243) For CY 2014, we established interim fina l work RVUs for these two codes based upon the survey’s 25 th percentile. As we discussed in the CY 2014 interim final rule with comment period, we believed that th e RUC-recommended work R VU for CPT code 37242 did not adequately take into account the su bstantial decrease in intraservice time. We indicated that we believed that the survey’s 25th percentile work RVU of 10.05 was more consistent with the

decreases in intraservice time sin ce its last valuation and more appropriately reflected the work of the procedure. Similarly, we did not believ e that the RUC-recommended work RVU for CPT code 37243 adequately considered th e substantial decrease in intr aservice time for the procedure; and we also use the survey’s 25 th percentile for CPT code 37243. Comment: Many commenters disagreed w ith our interim final valuation of 37242, including one who recommended a work RVU of 11.98. One commenter also believed the work RVU assigned to CPT code 37243 was inappropri ate and recommended instead a work RVU of 14.00. Commenters requested that the family of codes be referred for refinement. Response: After considerati on of the comments, we continue to believe that work RVUs

should reflect the decreases in intraservice time th at have occurred since the last valuation. As a result, we continue to believe that our CY 2014 interim final valu es are most appropriate and are finalizing them for CY 2015. A dditionally, we did not refer these codes for refinement panel

review because the criteria for refine ment panel review were not met.CMS-1612-FC 263 (6) Rigid Transoral Esophagoscopy (CPT Codes 43191, 43192, 43193, 43194, 43195 and 43196)

We established CY 2014 interim final work RVUs for the rigid transoral esophagoscopy codes using a ratio of 1 RVU per 10 minutes of intraservice time, resulting in a RVU of 2.00 for CPT code 43191, 3.00 for CPT code 43193, 3.00 for CPT code 43194, 3.00 for CPT code 43195,

and 3.30 for CPT code 43196. As we detailed in the CY 2014 final rule with comment period, the surveys showed that this ratio was refl ected for about half of the rigid transoral esophagoscopy codes. Additionally, we noted th at this ratio was further supported by the relationship between the CY 2013 work value of 1.59 RVUs for CPT code 43200 (Esophagoscopy, rigid or flexible; diagnostic, w ith or without collection of specimen(s) by brushing or washing (separate proc edure)) and its intraservice time of 15 minutes. For CPT code 43192, the 1 work RVU per 10 minutes ratio resulted in a value that was less than the survey low, and thus did not appear to be appropriate fo r this procedure. Therefore, we established a

CY 2014 interim final work RVU for CPT code 43192 of 2.45 based upon the survey low. Comment: Multiple commenters objected to the interim final work RVUs assigned to CPT codes 43191-43196, and expressed dissatisfac tion with CMS’s explanation for the valuations. The commenters specifically noted that CMS did not account for the difference in intensity between flexible and rigid scopes now that there are separate codes for these procedures. The commenters also suggested that the reduction in time in the RUC recommendations for codes 43191, 43193, 43195, and 43196 was also based on data from procedures with flexible scopes. The commenters also stated that our valu ation of services based upon 1 work RVU per 10 minutes of intraservice time was inappropriate and was based on the survey low, which is an anomalous outlier. The commenters suggested the following work RVUs based upon the RUC recommended values: 2.78 for CPT code 43191, 3.21 for CPT codeCMS-1612-FC 264 43192, 3.36 for CPT code 43193, 3.99 for CPT code 43194, 3.21 for CPT code 43195 and 3.36 or CPT code 43196. Finally, the commenters aske d that all these codes be referred to a refinement panel for reconsideration. Response: After considerati on of the comments, we agree that modification of the CY 2014 interim final values is appropriate. Base d upon the information provided in comments and further investigation, we believe th at greater intensity is involved in furnishing rigid than flexible transoral esophagoscopy. Accordingly, rather than assigning 1 work RVU per 10 minutes of

intraservice time as we did for the CY 2014 interim final, we are assigning a final work RVU to the base code, CPT code 41391, of 2.49. This wo rk RVU is based on increasing the work RVU of the previous comparable code (1.59) to refl ect the percentage increas e in time for the CY 2014 code. For the remaining rigid esophagoscopy code s, we developed RVUs by starting with the RVUs for the corresponding flexible esophagosc opy codes, and increasing those values by adding the difference between the base flexible esophagoscopy and the base rigid esophagoscopy

codes to arrive at final RVUs. We are estab lishing a final work RVU of 2.79 to CPT code 43192, 2.79 to CPT code 43193, 3.51 to CPT code 43194, 3.07 to CPT code 43195, and 3.31 to

CPT code 43196. These codes were not referred to refinement because the request did not meet

the criteria for referral. (7) Flexible Transnasal Eso phagoscopy (CPT codes 43197 and 43198)

We established CY 2014 interim final wo rk RVUs of 1.48 for CPT code 43197 and 1.78

for CPT code 43198. As detailed in the CY 2014 fi nal rule with comment period, we removed 2 minutes of the pre-scrub, dress and wait preservi ce time from the calculation of the work RVUs

that we established for CY 2014 for CPT codes 43200 and 43202 because we believed that unlike the transoral codes, which they correspond to, the transnas al services are not typically

furnished with moderate sedation.CMS-1612-FC 265 Comment: Multiple commenters objected to the work RVUs for these codes and in particular to CMS basing its valuation on the f act that these codes typically do not involve moderate sedation. Although the commenters agreed that these codes typically do not involve moderate sedation, they said that procedures involvi ng local/topical anesthes ia often take more work than those involving general sedation due to the difficulties of furn ishing services to a conscious and often anxious patient. Some also not ed that it ignores the time necessary to apply local/topical anesthesia and wait for it to take effect. A commenter urged CMS to establish values based upon the RUC reco mmendations. Commenters reque sted that these codes be

referred for refinement. Response: After consideration of the comments, we agree th at the work RVUs for these

codes should not be reduced because moderate se dation is not typically used. Accordingly, we agree with the RUC recommendation to assign the same work RVUs to these codes as to CPT code 43200 (Esophagoscopy, flexible, transoral; di agnostic, including collection of specimen(s) by brushing or washing when pe rformed) and 43202 (Esophagoscopy, flexible, transoral; with biopsy, single or multiple) the comparable transoral codes. We are finalizing work RVUs of 1.52 and 1.82 for CPT codes 43197 and 43198, respectiv ely. We did not refer these codes to refinement because the request did not meet th e criteria for refinement panel review. (8) Flexible Transoral Esophagoscopy, (CPT Codes 43200, 43202, 43204, 43205, 43211, 43212, 43213, 43214, 43215, 43227, 43229, 43231, and 43232)

We established CY 2014 interim final work RVUs for the flexible transoral esophagoscopy family, which are detailed in Tabl e 15. As we described in the CY 2014 final rule with comment period, to establish work values for these codes we used a variety of methodologies as did the RUC. The methodologi es used by CMS And the RUC include basing values on the surveys (either medians or 25th per centiles), crosswalking values to other codes,CMS-1612-FC 266 using the building block methodology, and valuing a family of codes based on the incremental

differences in the work RVUs between the codes be ing valued and another family of codes. As we did for the rigid transoral esophagoscopy codes, in addition to the methodologies used by the RUC, we also reduced the work RVUs for partic ular codes in direct pr oportion to the reductionin times that were recommended by the RUC. Using these methodologies, we assigned the RUCrecommended work RVUs for five codes in this family; for the other eight codes we used these same methodologies but because of different values for a base code or variation in the crosswalk

selected we obtaine d different values. Comment: Commenters objected to the inte rim final RVUs we assigned for CPT code 43200, the base code for flexible transoral esopha goscopy, because they did not believe the work RVU for the code should be less than they were as of CY 2013 when there was a single code to report both flexible and rigid es ophagoscopy services. Commenters also disagreed with the way we used standard methodologies to value many of these codes, includi ng using the ratio of 1 work RVU per 10 minutes of intraservice time to CPT code 43200. Commenters requested that we accept the RUC values for all the flexible transoral esophagoscopy codes and asked that we

refer all these codes to the refinement panel. Response: Although refinement was requested for all of the flexible transoral esophagoscopy codes, we found that the c odes (CPT codes 43204, 43205 and 43233) met the refinement criteria, and those were referred to th e refinement panel. After consideration of the comments and the refinement panel results, we are revising the work RVUs for many of the codes in this family. For CPT code 43200, which is the base code for flexible transoral esophagoscopy, we agree with commenters that a nother methodology is preferable to applying the work RVU ratio of 1 RVU per 10 minutes of intraservice time. In revaluing this service, we subtracted 0.07 toCMS-1612-FC 267 account for the 3 minute decrease in postservice ti me since the last valuation from the CY 2013 work RVU for the predecessor base code, whic h resulted in a work RVU of 1.52. We are finalizing this work RVU. The CY 2014 interim final work RVUs for CPT codes 43201, 43202, 43204, 43205 and 43215 were all based upon methodologies using the work RVU of the base code, 43200. As we are establishing a final value for CPT code 43200 th at is higher than the CY 2014 interim final value, we are also adjusting the work RVUs for the other codes based upon the new work RVU for CPT code 43200. We are finalizing a work RVU of 1.82 for 43201, 1.82 for 43202, 2.43 for 43204, 2.54 for 43205, and 2.54 for 43215. CPT codes 43204 and 43205 were considered by th e refinement panel. The refinement panel median for each of these codes was 2.77 and 2.88, respectively. The refinement panel discussion reiterated the information presented to the RUC and in the comments in response to the CY 2014 final rule with comment period, such as that the typical patient for these codes are

sicker and thus the work is more intense. B ecause we do not agree with commenters’ contention that higher work RVUs are warran ted since these codes involve th e sicker patients or that our methodology for calculating the interim final RVUs was inappropriate, we are establishing final values determined using these methodologies. Ho wever, due to the change in the base code, CPT code 43200, as discussed in the previous pa ragraph the final values for these codes are higher than the interim final values. In the CY 2014 final rule with comment period, we assigned an interim final work RVU of 4.21 to CPT code 43211 by using a compar able esophagogastroduodenoscopy (EGD) code and subtracting the difference in work between the base esophagoscopy and base EGD codes.

After consideration of the comments that indica ted the interim final work RVU of 4.21 was too low, we believe this code should instead be crosswalked to CPT code 31636 (BronchoscopyCMS-1612-FC 268 bronch stents), which we believe is a comparable service with comparable intensity. It has the same intraservice time and slightly higher total ti me. As a result we are finalizing a work RVU

of 4.30.

As we noted in the CY 2014 final rule with comment period, we crosswalked the interim

final work RVU for CPT 43212 to that of CPT code 43214. Since we are increasing the work RVU for CPT code 43214, we are also increasi ng the work RVU for CPT code 43212, which is consistent with comments that we had undervalued this procedure. As we detailed in the CY 2014 final rule with comment period, we based the work RVU

of 4.73 for CPT code 43213 on the value of CPT c ode 43220, increased proporti onately to reflect the longer intraservice time of CPT code 43213. Th e refinement panel median was 5.00 for this code. No new information was presented at the re finement panel. We continue to believe that 4.73 is the appropriate work R VU and are finalizing it. Based upon the information presented by comme nters about the typical patient and the advanced skills required for the procedure, we are changing our method of valuing CPT code

43214. We believe it should be crosswalked to CPT 52214 (cystoscopy), which we believe is similar in intensity. This result s in a final work RVU of 3.50 as co mpared to an interim final of 3.38. This refinement also supports the belief ma de by commenters that the work of CPT code 43214 is greater than the interim final work RVU. Therefore, we are finalizing a work RVU of

3.50 for CPT code 43214. For CPT code 43227, we modified the CY 2013 work RVU to reflect the percentage

decrease in intraservice time of 36 minutes to 30 minutes in the RUC recommendation to

establish a CY 2014 interim final value of 2.99. The commenters stated that the survey validates

the RUC recommendation of 3.26 and that the drop in intraservice time that upon which we based our change in the work RVU was inapprop riate since the intraservice time had not reallyCMS-1612-FC 269 changed. They contend that the change was fr om moving the time for mo derate sedation from intraservice to preservice. We disagree. We ha ve no information from the RUC that leads us to believe that when the pre-service packages we re developed several years ago and moderate sedation was explicitly recognized as a pre-serv ice item that the RUC also intended CMS to

assume that the intraservice times were no l onger correct. We believe that our proposed valuation methodology is correct and thus are finalizing a work RUV of 2.99. Commenters, disagreeing with our cro sswalk of CPT code 43229 to CPT code 43232,

stated that the two codes were not comparable. We disagree. We continue to believe this crosswalk is appropriate as the tim es and intensities are quite similar. We note that the RUC also bases crosswalks on the comparability of time a nd intensity of codes and not on the clinical similarity of work. Thus, we will continue this crosswalk. However, as discussed below, we are refining the interim final value of CPT code 43232 to 3.59 and thus are finalizing the work RVU

of 3.59 for CPT code 43229. For CPT code 43231, we added the work of an endobronchial ultrasound (EBUS) to the work of the base esophagoscopy code to arrive at our interim final value. The commenters disagreed with our approach, sta ting that the EBUS code is an add-on code and as such does not have pre- and postservice work. We agree that pre- and postservice work is not included in the

EBUS code nor should it be for the ul trasound portion of the examination of esophagus. Therefore, we are fi nalizing a work RVU of 2.90. For CPT code 43232, the commenters stated our interim final value is too low and that the work involved in this code is appropria tely reflected in the RUC recommendation. They objected to our basing the work RVU fo r 43232 on the difference between the RUCrecommended values for this code and CPT code 43231. We learned from the comments that the typical patient for this service has advanced cance r and agree that our interim final value may notCMS-1612-FC 270 represent the full extent of the wo rk involved in this procedure. Therefore, we are crosswalking this code to CPT code 36595 (Mechanical removal of pericatheter obstructiv e material (eg, fibrin sheath) from central venous device via separate venous access), which has identical intraservice time, slightly less total time, and a slightly hi gher intensity and are fi nalizing a work RVU of

3.59. (10) Esophagogastroduodenoscopy (E GD) (CPT codes 43233, 43235, 43236, 43237, 43238, 43239, 43242, 43244, 43246, 43247, 43249, 43253, 43254, 43255, 43257, 43259, 43266, and

43270.

We established interim final work RVUs for various EGD codes in the CY 2014 final rule with comment period. In this section, we discuss the 18 EGD codes on which we received comments disagreeing with or making recommendati ons for changes in our interim final values.

As we detailed in the CY 2014 final rule with comment period, we valu ed many of these codes by adding the additional work of an EGD to the comparable esophagoscopy (ESO) code. We determined the additional work of an EGD by subtracting the work RVU of CPT code 43200, the base ESO code, from the work of CPT code 43235, the base EGD code. For example, CPT code

43233 is an identical procedure to CPT code 43214 except that it uses EGD rather than ESO. We valued it by adding the additional work of EGD to the work RVU of CPT code 43214, resulting in an interim final wo rk RVU of 4.05. We valued the a dditional work the same way the RUC did in its recommendations. The following EGD codes were valued in the same way using the code in parentheses as the corre sponding ESO code: 43233 (43214), 43236 (43201), 43237 (43231), 43238 (43232), 43247 (43215), 43254 (43211), 43255 (43227), 43266 (43212), and 43270 (43229). In valuing CPT codes 43235, we agreed with the RUC recommended work

RVU difference between this EGD base code and the esophagoscopy base code, CPT 43200 but applied the difference to our CY 2014 RVU values . In a similar fashion, in valuing CPT codeCMS-1612-FC 271 43242 we agreed with the RUC recommended methodology of which took the increment between CPT code 43238 and CPT code 43237 but we applied the difference to our CY 2014 values. In order to value other EGD codes, we crosswalked the services to similar procedures; specifically for CY 2014 we crosswal ked CPT codes 43239 to 43236, 43246 to 43255, 43253 to

43242 and 43257 to 43238. We valued CPT code s 43244 and 43249 through acceptance of the

RUC work RVU recommendation. Lastly, we valued CPT code 43259 by adjusting the CY 2013

work RVU to account for the CY 2014 RUC recommended reduction in total time. Comment: For all codes, commenters objecte d to our work RVUs and said that our

reductions from the RUC recommendations were ba sed on a decrease in intraservice time that did not reflect a change in the time required to fu rnish the procedures but rather only a change in which part of the procedure the RUC includes th e moderate sedation time. Commenters disagree with our valuing CPT code 43233 based on the va lue of CPT code 43214, saying that CPT code

43233 is more intense due to the ri sk of perforation, and that th e achalasia patients are at high risk and poor candidates for surgery. Commente rs disagreed with our methodology for valuing CPT code 43235, and suggested that we use th e RUC crosswalk to CPT code 31579, contending that the slight reductions in pre- and post-service times are consistent with the slight drop in the RUC-recommended RVU. For CPT code 43237, co mmenters also noted a rank order anomaly

because the interim final work RVU for this code is the same as for CPT code 43251. Commenters said that the robust survey data on CPT code 43238 should override CMS decisions. With regard to CPT code 43239, comm enters suggest that th e survey is wrong and further point to the fact that our valuation results in the same value for CPT code 43239 as the base EGD code, which they state is not appropr iate due to the additional work in CPT code 43239. Commenters disagreed with our valu e for CPT code 43242 stating that we inappropriately valued CPT code 43259, which we used in calculating the work RVUs for CPTCMS-1612-FC 272 code 43242. Commenters objected to our value of CPT code 43246 because they disagree with

the work RVU for the code that it is crosswal ked to, CPT code 43255. Commenters urged us to modify our work RVU for CPT code 43247 to equal the RUC recommendation. For CPT code 43253, commenters did not disagree with the va luation approach, but disagreed with the valuation we had assigned to the base code, CPT code 43259, which affected the valuation of CPT code 43253. Comments indicated that they did not understand how th e value of CPT code 43254 was derived. Commenters indicated that they disagreed with the reduction in the work in

CPT code 43255 due to a decrease in time. Th ey also cited that this was an emergency procedure in unstable patients and that it was mo re difficult to control bleeding in the stomach than in the esophagus. For CPT code 43257, commenters disagreed with our crosswalk to CPT code 43238 indicating that CPT code 43257 wa s more intense than CPT code 43238. Commenters acknowledged that reduced times shoul d result in reduced work, but disagreed with our proportional reduction approach. Commenters agreed with our appr oach to valuing CPT code 43266, but disagreed with the valuation of th e CPT code 43212, that we used as the base. With regard to CPT code 43270, commenters disagr eed with using CPT code 43229 as the base. Response: For each of these codes, commenter s were concerned that we did not accept

the RUC-recommended values. Their comm on reasoning for urging us to accept the RUCrecommended values was that moderate sedation time had been removed from intraservice time and that these intraservice time changes should not result in a change in the RUC-recommended RVU. However, for CPT codes 43233, 43236, 43237, 43238, 43247, 43254, 43255, 43266, and 43270, we used the standard methodology describe d above for valuing EGD codes and did not base our values on the time change. Thus, a ny refinements to the RUC recommendations for the EGD codes are solely due to refinements in the ES O codes. We discussed our valuations of these codes in the previous section. Si nce we have finalized most of the ESO codes at higher levelsCMS-1612-FC 273 than the CY 2014 interim final values, we are ma king corresponding increases in the EGD codes. Therefore, we are finalizing these codes at the following work RVUs: 43233 at 4.17, 43235 at 2.19, 43236 at 2.49, 43237 at 3.57, 43238 at 4.26 , 43247 at 3.21, 43254 at 4.97, 43255 at 3.66, 43266 at 4.17, and 43270 at 4.26.

CPT code 43233 was referred to the refinement panel and received a median work RVU of 4.26. As outlined above, we are finalizi ng a work RVU of 4.17 for CPT code 43233 at 4.17, which is higher than our interim value of 4.05, but consistent with our valuation of the other

EGD codes. We do not believe that the commen ts provided at the refinement panel justify adoption of the higher median value.

The interim final work value of CPT code 43239 was crosswalked to the work RVU of

CPT code 43236. Since we increased the final work RVU from the interim final for this code,

the final work RUV of CPT code 43239 increases to 2.49. (11) Endoscopic Retrograde Cholangi opancreatography (ERCP) (CPT codes 43263, 43274, 43276, 43277 and 43278) In the CY 2014 final rule with comment period we established interim final work RVUs for several ERCP codes due to coding revisions . For all those codes not discussed in this section, we are finalizing the interim final wo rk RVUs. For CPT code 43263, we established an interim final work RVU based upon a crosswalk to CPT code 43262. As we detailed in the CY 2014 final rule with comment period, we valued CPT codes 43274, 43276, and 43278 using the

same formula that the RUC used in determin ing its recommendations , but substituting our

interim final work RVUs for codes used in the formula for the RUC-recommended values. CPT code 43277 was valued using the survey 25 th percentile. Comment: Commenters objected to our valu ation of CPT 43263 based upon a crosswalk to CPT code 43262, saying that CPT 43263 is more in tense and has greater risks than CPT codeCMS-1612-FC 274

43262. Commenters also indicated that we unde restimated the intensity of CPT code 43276 indicating that CPT code 43276 t ypically involves replacing sten ts that are overgrown with cancerous tissues. They also sa id that we underestimated the intensity of CPT coded 43274 and

43277. Commenters further took issue with our valuing CPT code 43277 based upon the survey when most codes in this family were valued based upon the incremental formula. Commenters stated that CPT code 43278 is valued incorrectly because we did not correctly value CPT code 43229, which is used in the formula we used to value CPT code 43278. Response: After consideration of the comments, we continue to believe that CPT code 43263 is the appropriate crosswalk for CPT code 43262 and we are finalizing a work RVU of 6.60 for that code. With regard to CPT code 43274, we continue to believe the formula

described in the CY 2014 final rule with comm ent period is the appropriate methodology. We are finalizing a work RVU of 8.58 for CPT code 43274 using the final values for the codes used in the formula and thus increasing the work RVU from the interim final value of 8.48. Similarly, we are finalizing a work RVU of 8.94 for CP T code 43276 based upon the formula described in the CY 2014 final rule with comment period adjust ed for changes in the final work RVUs for values used in the formula. For CPT code 43277, we continue to believe the survey 25 th percentile is appropriate. This va luation is supported by a drop in the intraservice time from the code it replaces. Thus, we are finalizing the interim final work RVU of 7.00. For CPT code 43278, we continue to believe use of the RUC formul a for this code is most appropriate, and we are adjusting the work RVU to reflect final work RVUs for values used in the formula. The final

work RVU for CPT code 43278 is 8. (12) Spinal Injections (CPT codes 62310, 62311, 62318 and 62319)CMS-1612-FC 275 We proposed new work RVUs for these codes in the PFS proposed rule. (79 FR 40338- 40339). See section II.B.3 for a discussion of the valuation of these codes, and a summary of public comments and our responses. (13) Laminectomy (CPT Codes 63045, 63046, 63047 and 63048)

We established interim final work R VUs for CPT codes 63047 and 63048 for CY 2014.

As we indicated in the CY 2014 final rule with comment period, we had identified CPT code 63047 as potentially misvalued thro ugh the high expenditure proce dure code screen and the RUC

included a recommendation for CPT code 63048. We noted that, to appropriately value these codes, we need to consider the other two codes in this family: CPT codes 63045 (Laminectomy, facetectomy and foraminotomy (unilateral or bila teral with decompression of spinal cord, cauda equina and/or nerve root[s], [e g, spinal or lateral recess stenosis]), single vertebral segment; cervical) and 63046 (Laminectomy, facetectomy and foraminotomy (unilateral or bilateral with decompression of spinal cord, cauda equina and/or nerve root[s], [eg, spinal or lateral recess stenosis]), single vertebral segment; thoracic). Although we did not receive recommendations for CPT codes 63045 and 63046, we established CY 2014 interim final work RVUs for CPT codes 63047 and 63048 of 15.37 and 3.47, respectively, ba sed upon the RUC recommendations. We noted that we expected to review these valu es in concert with the RUC recommendations for

CPT codes 63045 and 63046 when we received them. Comment: Commenters questioned our determination that CPT codes 63047, 63048, 63045 and 63046 constituted a family, noting that CPT codes 63045 and 63046 require different work. Commenters questioned the value of resurv eying this set of codes as a family since CPT

codes 63045 and 63046 constitute a sm all percentage of the total volume of these codes. The survey of CPT codes 63047 and 63048 did not reveal significant change in the values of theCMS-1612-FC 276 codes, and the work involved in resurveying would be burdensome for those involved. One commenter urged us to withdraw our request to survey these codes. Response: We continue to believe that it is appropriate to value a family of codes together in order to maintain relativity. We also continue to believe that CPT codes 63045 and 63046 are indeed in the same family as CPT code s 63047 and 63048 due to similarity of service.

We have received new RUC recommendatio ns for CPT code 63045 and 63046, but did not receive them in time to include in this rule. As a result, we will finalize the interim work values

for CPT codes 63047 and 63048 for CY 2015. (14) Chemodenervation of Muscles (CPT codes 64616, 64617, 64642, 64643, 64644, and 64645) We assigned refined interim final work RVU values of 1.53 to CPT code 64616 and 1.90

to CPT code 64617. As detailed in the CY 2014 fi nal rule with comment period, we refined the

RUC-recommended work RVUs of 1.79 for CPT code 64616 and 2.06 for CPT code 64617 to reflect the deletion of an outpati ent visit that was included in the predecessor code, CPT code 64613 (chemodenervation of muscle(s); neck muscle (s) (eg, for spasmodic torticollis, spasmodic dysphonia)). We also explaine d that since CPT code 64617, ch emodenervation of the larynx, includes EMG guidance when furnished we dete rmined the interim final work RVU by adding the work RVU for CPT code 95874 (Needle electromyography for guidance in conjunction with chemodenervation (List separately in addition to code for primary pro cedure)) to the CY 2013

work RVU for CPT 64616. For CY 2014, we assigned interim final work RVUs for CPT code 64643 and CPT code 64645 of 1.22 and 1.39, respectively. As we explai ned in the CY 2014 final rule with comment period, we refined the RUC-recommended work R VUs for these add-on codes by subtracting the RVUs to account for 19 minutes of pre-service tim e and the decrease in time for furnishing theCMS-1612-FC 277 add-on service. Additionally, we based the global period for these codes on the predecessor code, CPT code 64614 (chemodenervation of muscle(s); extremity and/ or trunk muscle(s) (eg, for dystonia, cerebral palsy, multiple sclerosis)), wh ich was deleted for CY 2014. Therefore, we assigned 10-day global periods to the services. Comment: Most commenters disagreed with the CY 2014 interim final work RVU valuations for CPT codes 64616, 64643, and 64645. On e commenter stated that the work RVU for the predecessor code, CPT code 64614, did not ta ke into account the full level of intensity, time, and work that it takes to perform the serv ice. This commenter also disagreed with the

times for this service. Several commenters disagreed with the valuation of CPT code 64616 saying that we ignored the RU C recommendation which was based on survey data and RUC

deliberations and asked that we value the code based upon the RUC recommendation. Several commenters disagreed with the valuations for CPT codes 64643 and 64645 saying that CMS did not explain our valuation, ignored the fact that the RUC disc ounted the add-on codes based on the pre- and post-service time and did not articulate any basis for our valuation decision. Several commenters requested refinement of the codes in the chemodenervation family. Response: After consideration of the comme nts we are finalizing the interim final work

RVUs and time for these codes. We continue to be lieve that our valuations for this family take

into account the full level of inte nsity, time, and work that are requi red to furnish these services. Additionally, we disagree with commenters that we did not explain our valuation of CPT codes

64643 and 64645. In the CY 2014 final rule with comment period, we detail and thoroughly explain the methodology utilized to valu e CPT codes 64643 and 64645. Additionally, the request for refinement panel review was not granted as the criteria for refinement were not met. (15) Impacted Cerumen (CPT code 69210)CMS-1612-FC 278 After it was identified as a potentiall y misvalued code pursuant to the CMS high expenditure screen, CPT code 69210, which de scribes removal of impacted cerumen, was revised from being applicable to ‘‘1 or both ears’’ to a unilateral code ef fective January 1, 2014. For Medicare purposes we limited the code to b illing once whether it wa s furnished unilaterally or bilaterally because we believed the procedur e would typically be furnished in both ears as the physiologic processes th at create cerumen impaction likely would affect both ears. Similarly,

we continued the CY 2013 value as our interim final CY 2014 value since for Medicare purposes the service was unchanged. Comment: Commenters requested that we allow CPT code 69210 to be billed twice when it is furnished bilaterally, consistent with code descriptor . Commenters stated that our assumption regarding the physiologic processes th at create cerumen was flawed and requested we provide a clinical rationale and/or literature to support our claim. Lastly, the commenters requested guidance from the agency as to how best deal with this CPT code; specifically, if it

should be sent to CPT for clarific ation or if not, that we provide further guidance as to how this procedure should be bill ed using the new code. Response: We continue to believe that the procedure will be furnis hed in both ears as the physiologic processes that create cer umen impaction likely would affect both ears. As a result, we will continue to allow only one unit of CPT 69210 to be billed when furnished bilaterally and are finalizing our CY 2014 interim final work RVU for this service. (16) Magnetic Resonance Imaging (M RI) Brain (CPT codes 77001, 77002, and 77003)

As detailed in the CY 2014 final rule w ith comment period, we agreed with the RUCrecommended values for CPT codes 77001, 77002 and 77003 but were concerned that the

recommended intraservice times for all three co des was generally higher than the procedure codes with which they were typically billed. We sought additional public comment and inputCMS-1612-FC 279 from the RUC and other stakeholders regard ing the appropriate relationship between the intraservice time associated with fluoroscopi c guidance and the intraservice time of the procedure codes with which they are typically billed. Comment: Some commenters disagreed w ith the concern expressed by CMS that the intraservice time for codes 77001, 77002 and 77003 is higher than the codes alongside which they are typically billed, as the commenters believ ed that the combinations being used to support this concern were not appropriate, and they requ ested additional examples to support its concern.

The commenters believed that the concerns CMS expressed are unfounded and that we should assign work RVUs of 0.38, 0.54, and 0.60 fo r CPT code 77001, 77002, and 77003, respectively. Response: We continue to have concerns regarding the appropriate relationship between

the intraservice time associated with fluorosc opic guidance and the intr aservice time of the procedure codes with which they ar e typically billed and will cont inue to study this issue. We are finalizing the CY 2014 interim final values for CY 2015. (17) Immunohistochemistry (CPT codes 88342 and 88343 and HCPCS codes G0461 and G0462)

These codes were revised for CY 2015. Fo r discussion of valuation for CY 2015, see

section II.G.3.b. (18) Optical Endomicroscopy (Code 88375)

As detailed in the CY 2014 final rule with comment period, we belie ved that the typical optical endomicroscopy case would involve only the endoscopist, and CPT codes 43206 and 43253 were valued to reflect this. Accordingly, we believed a separate payment for CPT code 88375 would result in double payment for a por tion of the overall optical endomicroscopy service. Therefore, we assigned a PFS procedure status of I (Not valid for Medicare purposes. Medicare uses another code for the reporting of and the payment for these services) to CPT code

88375.CMS-1612-FC 280 Comment: Multiple commenters objected to CMS’s decision to assign a PFS status indicator of “I” to code 88375, st ating that the code already in cludes distinctions that would prevent a physician from billi ng the code when it would double count work. The commenters urge CMS to assign CPT code 88375 a Medicare st atus of A (Active Code), and to immediately publish RVUs associated with the service. Response: In our re-review of this pr ocedure and consideratio n of the information provided by commenters, we belie ve the coding is adequate to avoid double payment for a portion of the service. Accordingly, we assigned a Medicare status indica tor of A (Active). To value this service, we based the RVUs on t hose assigned to CPT code 88329, adjusted for the

difference in intraservice time between the two codes. We are assigning a final work RVU of

0.91 for CPT code 88375 for CY 2015. (19) Speech Language (CPT codes 92521, 92522, 92523 and 92524) In CY 2014, we assigned CY 2014 interim final work RVUs of 1.75 and 1.50 for CPT codes 92521 and 92522, respectively, as the HCPAC recommended. For CPT code 92523, we disagreed with the HCPAC-recommended work R VU of 3.36. We believed that the appropriate value for 60 minutes of work for the speech evaluation codes was reflected in CPT code 92522,

for which the HCPAC recommended 1.50 RVUs. Because the intraservice time for CPT code 92523 was twice that for CPT code 92522, we assigned a work RVU of 3.0 to CPT code 92523. Similarly, since CPT codes 92524 and 92522 had id entical intraservice time recommendations and similar descriptions of work we believed that the work RVU for CPT code 92524 should be the same as the work RVU for CPT code 95922. Therefore, we assigned a work RVU of 1.50 to

CPT code 92524. Comment: Commenters disagreed with th e interim final work RVUs assigned to CPT codes 92523 and 92524, saying they based on inaccura te assumptions. Commenters stated thatCMS-1612-FC 281 survey respondents appropriately took time and effort into account when valuing CPT code 92523 but had difficulty using a time -based reference code to valu e the RVU of an untimed code

like CPT code 92523. Commenters noted that th e HCPAC acknowledged that the work of the

second hour involved in CPT c ode 92523 is indeed more intense than the first hour. Additionally, commenters stated that the work RVU reduction of CPT code 92524 was arbitrary because it was based solely on intraservice time a nd failed to recognize the more difficult aspects of performing the service compared to th at of CPT code 92522. Commenters requested

reconsideration of CPT codes 92523 a nd 92524 through refinement panel review. Response: We believe that our interim final work RVU is most appropriate for these

services. In the HCPAC recommendation for CPT code 92523 the affected specialty society stated that its survey results were faulty fo r this CPT code because those surveyed did not consider all the work necessary to perform th e service. The commenters did not provide any

information that demonstrates that our valuations fail to fully account for the intensity, work, and time required to perform these services. Theref ore, we are finalizing our CY 2014 interim final

values for CY 2015. We did not refer these codes to refinement because the request did not meet

the criteria for refinement. (20) Percutaneous Transcathe ter Closure (CPT code 93582)

As detailed in the CY 2014 final rule w ith comment period, we reviewed new CPT code 93582. Although the RUC compared this code to CPT code 92941 (percutaneous transluminal

revascularization of acute tota l/subtotal occlusion dur ing acute myocardial infarction, coronary artery or coronary), which ha s a work RVU of 12.56 and 70 mi nutes of intraservice time, it recommended a work RVU of 14.00, the survey’s 25t h percentile. We agreed with the RUC that CPT code 92941 is an appropriate comparison code and believed that due to the similarity inCMS-1612-FC 282 intensity and time that the codes should be valu ed with the same work RVU. Therefore, we assigned an interim final work RVU of 12.56 to CPT code 93582. Comment: One commenter disagreed with the work RVU valuation of CPT code 93582 because they believed it did not accurately reflect the intensity of the procedure, particularly in treating infants. The commenter stated that the RUC concl uded that a 55 percent work differential exists between performing this service on a child versus an adult - a fact that they stated supports the higher work RVU recommended by the RUC. As a result, the commenter suggests we assign the RUC-recommended wo rk RVU to CPT code 93582. A commenter requested referral to the refinement panel. Response: We continue to believe that CPT code 92941 is an appropriate comparison code to CPT code 93582 due to similarity in inte nsity and time and, as a result, the codes should

be valued with the same work RVU. Theref ore, we are finalizing our CY 2014 interim final

work RVU of 12.56 to CPT code 93582 for CY 2015. We did not refer this code to refinement because the request did not meet the criteria for refinement. (21) Duplex Scans (CPT Codes 93925, 93926, 93880 and 93882)

For CY 2014 we maintained the CY 2013 RVUs for CPT codes 93880 and 93882. We

were concerned that the RUC -recommended values for CPT codes 93880 and 93882, as well as our final values for CPT codes 93925 (Duplex scan of lower extremity arteries or arterial bypass grafts; complete bilateral study) and 93926 (Duplex scan of lower ex tremity arteries or arterial bypass grafts; unilateral or limited study), did not maintain the appr opriate relativity within the family and referred the entire family to the RU C to assess relativity among the codes and then recommend appropriate work RVUs. We also re quested that the RUC consider CPT codes 93886 (Transcranial Doppler study of th e intracranial arteries; comple te study) and 93888 (TranscranialCMS-1612-FC 283 Doppler study of the intracrania l arteries; limited study) in c onjunction with the duplex scan codes to assess the relativity between and among the codes. Comment: One commenter questioned why we did not include all duplex scan codes we determined to be part of the family in our or iginal request to the RU C. Another commenter opposed our valuation approach and stated that we should not redefine the codes in this family and that we should reject the RUC recommendations. Response: The valuations for CPT codes 93880, 93882, 93925, 93926, 93886 and 93888 are included in this year’s valuations in section II.G.3.b (22) Interprofessional Telephone/Internet C onsultative Services (CPT Codes 99446, 99447, 99448 and 99449) In CY 2014 we assigned CPT codes 99446, 99447, 99448, and 99449 a PFS procedure status indicator of B (Bundled code. Payments for covered serv ices are always bundled into payment for other services, which are not specified. If RVUs ar e shown, they are not used for Medicare payment). If these services are covered, payment for them is subsumed by the payment for the services to which they are bundled (for example, a telephone call from a hospital nurse regarding care of a patient) because Medica re pays for telephone consultations regarding beneficiary services as a part of other services fu rnished to the beneficiary. Comment: A commenter expressed concern that the services covered by codes 99446- 99449 were bundled together, and that no RVUs were published for these codes. The commenter observed that CMS compares the servi ces to contact between nurses and patients in justifying its decision to bundle the services in with other work, a nd stated that this comparison is inappropriate to use regarding consultation between physicians. The commenter also stated

that these services are vital in providing specific specialty expert ise in areas where timely faceto-face service is not a viable opt ion. The commenter urged that th e status of these services beCMS-1612-FC 284 changed to “Active,” or at least “Non-covered,” and that the RUC-recommended values for these services be published. Response: Medicare pays for telephone cons ultations regarding bene ficiary services as part of other services furnished to a beneficiary. As a result, we continue to believe that CPT codes 99446- 99449 are bundled; and we are finalizing the PFS procedure status indicator of B

for these codes for CY 2015. b. Finalizing CY 2014 Inte rim Direct PE Inputs i. Background and Methodology In this section, we address in terim final direct PE inputs as presented in the CY 2014 PFS final rule with comment period and displayed in the final CY 2014 direct PE database available

on the CMS website under the downloads at http://www.cms.gov/PhysicianFeeSched/PFSFRN/list.asp#TopOfPage

. On an annual basis, the RUC provides CMS w ith recommendations regarding PE inputs for new, revised, and potentially misvalued codes. We review the RUC-recommended direct PE inputs on a code-by-code basis. When we determine that the RUC recommendations appropriately estimate the direct PE inputs (clinical labor, disposable supplies, and medical equipment) required for the typical service and reflect our payment policies, we use those direct PE inputs to value a service. If not, we refine the PE inputs to better re flect our estimate of the PE resources required for the service. We also confirm whether CPT code s should have facility and/or nonfacility direct PE inputs and refine the inputs accordingly.

In the CY 2014 PFS final rule with comment period (78 FR 74242), we addressed the general nature of some of our common refineme nts to the RUC-recommended direct PE inputs, as well as the reasons for refinements to particul ar inputs. In the following sections, we respond to the comments we received regarding comm on refinements we made based on establishedCMS-1612-FC 285 principles or policies. Following those disc ussions, we summarize and respond to comments received regarding other refine ments to particular codes.

We note that the interim final direct PE i nputs for CY 2014 that are being finalized for CY 2015 are displayed in the final CY 2015 dire ct PE input database, available on the CMS

website under the downloads for the CY 2015 PFS final rule at www.cms.gov/PhysicianFeeSched / . The inputs displayed there have also been used in developing the CY 2015 PE RVUs as displayed in Addendum B of th is final rule with comment period.

Comment : Commenters indicated that it would be helpful to have additional information about the specific rationale used in developing refinements, and specifically requested that CMS provide more information regarding how CMS ma kes the determination of whether an item is typical. Response : We continually seek ways to increase opportunity for public comment. In response to comments received, we have provided more detailed explanations about refinements

made for the CY 2015 interim final direct PE in puts. We recognize that we make assumptions about what is typical, and note that we welcome objective data th at provides information about the typical case. We prefer that this info rmation be submitted through the notice and comment rulemaking process. We also refer interested stake holders to section II.F. of this final rule with comment period, in which we provide extensive disc ussion of the changes to the process that we are finalizing for valuing new, revi sed, and potentially misvalued codes.

ii. Common Refinements (1) Equipment Time Prior to CY 2010, the RUC did not genera lly provide CMS with recommendations regarding equipment time inputs. In CY 2010, in the interest of ensuring the greatest possibleCMS-1612-FC 286 degree of accuracy in alloca ting equipment minutes, we reque sted that the RUC provide equipment times along with the other direct PE recommendations, and we provided the RUC with general guidelines regarding appropriate equipment time inputs. We continue to appreciate the RUC’s willingness to provide us with these additional inputs as part of its PE

recommendations. In general, the equipment time inputs corres pond to the service period portion of the clinical labor times. We have clarified this prin ciple, indicating that we consider equipment time as the times within the intra-service period when a clinician is using the piece of equipment plus any additional time that the piece of equipment is not available for use for another patient due to its use during the designated pr ocedure. For services in whic h we allocate cleaning time to portable equipment items, because the equipment doe s not need to be cleaned in the room that contains the remaining equipment items, we do not include that time for the remaining equipment items as they are available for use fo r other patients during that time. In addition, when a piece of equipment is typically used dur ing any additional visits included in the global period for a service, the equipment ti me would also re flect that use. We believe that certain highly technical pi eces of equipment and equipment rooms are less likely to be used during all of the pre-se rvice or post-service task s performed by clinical labor staff on the day of the procedure (the c linical labor service period) and are typically available for other patients even when one member of clinical staff may be occupied with a preservice or post-service task rela ted to the procedure. Some commenters have repeatedly objected to our rationale for refinement of equipment minutes on this basis. We acknowledge the comme nts we received reiterating those objections

to this rationale and refer readers to our extens ive discussion in response to those objections inCMS-1612-FC 287 the CY 2012 PFS final rule with comment period (76 FR 73182). In the following paragraphs,

we address new commen ts on this policy.

Comment : A commenter indicated that CMS rem oved minutes assigned to vascular

ultrasound rooms for activities that CMS does not believe take place in the room, but CMS did not provide factual support for th is assumption. The commenter fu rther stated that CMS did not

articulate the connection between the relevant data that the Administrative Procedures Act (APA) requires CMS to consider and the c onclusion that CMS reached. The commenter indicated that they conducted a survey of a significant number of providers, in which most providers indicated that they performe d these pre-service tasks in the room. Response : We note that we would welcome comments that include vetted survey results, especially where the data are in cluded. Statements regarding th e existence of data to support commenters’ assertions do not pr ovide us with information to support conclusions based on the data. We acknowledge that we make assumptions a bout we believe to be typical. If there are data that support or refute these assumptions, we would be interested in reviewing that

information. We would be most interested in revi ewing survey data that address multiple points of our assumptions regarding high-cost equipment, including how many pr ocedures are furnished in a day, how often the equipment is bei ng used, and other such information.

Comment : A commenter stated that CMS shoul d publish, on a quarterly basis, refinements to the equipment times, rather th an waiting until the fina l rule to publish these changes. Response : We appreciate the commenter’s concer n about our making available timely information about refinements to practice expense inputs. We note that since we do not review and make refinements to practice expense i nputs on a quarterly ba sis, we do not have information to publish on a quarterly basis. Ra ther, we have reviewed and refined practiceCMS-1612-FC 288 expense recommendations from the RUC on an a nnual basis for the subset of codes for which recommendations have been provided to us. Be cause we have received many requests from stakeholders to publish our refinements as proposals in the proposed rule rather than in the final rule, we are finalizing a change in the process in which changes to RVUs and direct PE inputs will be included in the proposed rule rather than first appearing in the final rule with comment period. We refer readers to section II.F. of th is final rule with comment period for further information about this change. We believe that this process will address commenters’ concerns about having an opportunity to review these ch anges prior to the publis hing of the final rule.

Comment : Several commenters asked that CMS identify what constitutes a highly technical piece of equipment. Response : As we have previously indicated, during our review of all recommended direct PE inputs, we consider such items as th e degree of specificity of a piece of equipment, which may influence whether the equipment item is likely to be stored in the same room in which the clinical staff greets and gowns, obtains vitals, or provides educa tion to a patient prior to the procedure itself. We would expect that items that are highly specific to particular procedures would be moved between rooms for thos e procedures. We also consider the level of portability (including the leve l of difficulty involved in cleaning the equipment item) to determine whether an item could be easily tran sferred between rooms before or after a given procedure. Items that are portable would also be expected to be moved between rooms. We also examine the prices for the particular equipmen t items to determine whether the equipment is likely to be located in the same room used for all the tasks undertaken by clinical staff prior to and following the procedure. We believe that high ly expensive equipment would not be kept in a

location that does not allow for its maximum utilization. For each service, on a case-by-case basis, we look at the description provided in the RUC recommendation a nd consider the overlapCMS-1612-FC 289 of the equipment item’s level of specificity, portability, and cost; and, consistent with the review of other recommended direct PE inputs, we make the determination of whether the recommended equipment items are highly technical. We note that it is not practical to ensure that all of the existing equipment time in the database is allocated accordingly, but as we review any

recommendations received from th e RUC, we make this determination. To provide stakeholders with examples of the types of equipment items th at are and are not consid ered highly technical,

we have listed several items below and indi cated whether they ar e highly technical.

TABLE 16: Classification of Highly Technical Equipment Highly Technical Not Highly Technical Item CMS Code Price Item CMS Code Price room, CT EL007 $1,284,000.00 Light, exam EQ168 $1,630.12 accelerator, 6-18 MV ER010 $1,832,941.00 Table, exam EF023 $1,338.17 gamma camera system, single-dual head SPECT CT ER097 $600,272.00 Chair, medical recliner EF009 $829.03

(2) Standard Tasks and Minutes for Clinical Labor Tasks In general, the pre-service, service peri od, and post-service c linical labor minutes associated with clinical labor inpu ts in the direct PE input databa se reflect the sum of particular tasks described in the information that accompanies the recommended direct PE inputs, commonly called the “PE worksheets.” For most of these described tasks, there are a

standardized number of minutes , depending on the type of proce dure, its typical setting, its global period, and the other proce dures with which it is typically reported. The RUC sometimes recommends a number of minutes either greater than or less than the time typically allotted for certain tasks. In those cases, CMS staff reviews the deviations from the standards to determine their appropriateness. When we do not accept the RUC-recommended exceptions , we refine the interim final direct PE inputs to match the standa rd times for those tasks. In addition, in casesCMS-1612-FC 290 when a service is typically billed with an E/M, we remove the pr e-service clinical labor tasks to avoid duplicative inputs and to re flect the resource costs of fu rnishing the typical service. In general, clinical labor tasks fall into one of the categories on the PE worksheets. In

cases where tasks cannot be attributed to an existing category, the tasks are labeled “other clinical activity.” In these instances, CMS sta ff reviews these tasks to determine whether they

are similar to tasks delineated for other services under the PFS. For those tasks that do not meet this criterion, we do not accept those c linical labor tasks as direct inputs. (3) Equipment Minutes for Film Equipment Inputs

In section II.A. of this final rule with co mment period, we finalize our proposal to accept the RUC recommendation to remove inputs associat ed with film technology that are associated with imaging services. We acknowledge comments received regarding the minutes allocated to equipment items associated with film technology ; we will not address those comments below, because subsequent to the publication of the CY 2014 final rule with comment period, as

discussed in section II.A. of th is final rule with comment peri od, we finalized our proposal to remove these inputs from the Direct PE database, and thus the comments are no longer relevant. (4) Standard Inputs for Moderate Sedation In establishing interim final direct PE input s for services that contain the standard moderate sedation input package, we refi ned the RUC’s recommendation by removing the stretcher (EF018) and adjusting the standard m oderate sedation equipment inputs to conform to the standard moderate sedation equipment times. These procedures are listed in Table 17.

Comment : Commenters objected to our refinement of the standard moderate sedation equipment input times to conform to the modera te sedation equipment standard times, since it

decreased the time allocated to these equipment items. Response : We note that for moderate sedation pro cedures, the equipment time is tied toCMS-1612-FC 291 the RN time rather than to the entire service pe riod. Specifically, this time includes 2 minutes for sedate/apply anesthesia, 100 per cent of physician intraservice time, and 60 minutes of postprocedure time for every 15 mi nutes of RN monitoring time. The times included in Table 17

reflect this standard. We note that for all procedures in Table 17 the times allocated to the equipment items that were interim final for 2014 were already consistent with the moderate sedation standard equipment times, with the exception of CPT code 37238, which was mistakenly allocated 257 minutes, when the correct time is actually 242 minutes.

Comment : Commenters indicated that for office e ndoscopic procedures, the stretcher is typically used throughout the en tire procedure, as well as during post-procedure monitoring.

Other commenters indicated that the stretcher is requi red during the moderate sedation recovery time. The commenters requested that we include the stretcher for those procedures, and that we reduce the increased time allocated to the power table. Response : In section II.A. of this final rule with comment period, we finalized our proposal to modify the standard moderate sedatio n input package to include a stretcher for the same length of time as the other equipment items in the moderate sedation package. We

indicated that the revise d package would be applied to releva nt codes as we review them through future notice and comment rulemaking. We have therefore refined those inputs to incorporate

the stretcher for these codes listed in Table 17. Since we are incor porating the stretcher, we have removed the power table for procedures in whic h a power table was previously included. We will hold these procedures as interim final for CY 2015 due to the insertion of the stretcher and removal of the power table. We are therefore finalizing the PE inputs for the procedures c ontaining the standard moderate sedation inputs, with th e additional refinements of incl uding the stretcher for all of these procedures, removing the power table for the codes noted in Table 17 as containing aCMS-1612-FC 292 power table, and adjusting the equipment time for CPT code 37238. We note that these changes are displayed in the final CY 2015 direct PE i nput database, available on the CMS website under

the downloads for the CY 2015 PFS final rule at www.cms.gov/PhysicianFeeSched /

.CMS-1612-FC 293

TABLE 17: CPT Codes with Stretcher Added

CPT Code Short Descriptor Moderate Sedation Contained Power Table? 10030 Guide cathet fluid drainage 152 36245 Ins cath abd/l-ext art 1st 167 37236 Open/perq place stent 1st 332 37238 Open/perq place stent same 242 37241 Vasc embolize/occlude venous 272 37242 Vasc embolize/occlude artery 342 37243 Vasc embolize/occlude organ 362 37244 Vasc embolize/occlude bleed 332 43200 Esophagoscopy flexible brush 77 Yes 43201 Esoph scope w/submucous inj 80 Yes 43202 Esophagoscopy flex biopsy 82 Yes 43206 Esoph optical endomicroscopy 92 Yes 43213 Esophagoscopy retro balloon 107 Yes 43215 Esophagoscopy flex remove fb 82 Yes 43216 Esophagoscopy lesion removal 84 Yes 43217 Esophagoscopy snare les remv 92 Yes 43220 Esophagoscopy balloon <30mm 82 Yes 43226 Esoph endoscopy dilation 87 Yes 43227 Esophagoscopy control bleed 92 Yes 43229 Esophagoscopy lesion ablate 107 Yes 43231 Esophagoscop ultrasound exam 107 Yes 43232 Esophagoscopy w/us needle bx 122 Yes 43235 Egd diagnostic brush wash 77 Yes 43236 Uppr gi scope w/submuc inj 82 Yes 43239 Egd biopsy single/multiple 77 Yes 43245 Egd dilate stricture 85 Yes 43247 Egd remove foreign body 92 Yes 43248 Egd guide wire insertion 82 Yes 43249 Esoph egd dilation <30 mm 82 Yes 43250 Egd cautery tumor polyp 82 Yes 43251 Egd remove lesion snare 82 Yes 43252 Egd optical endomicroscopy 92 Yes 43255 Egd control bleeding any 92 Yes 43270 Egd lesion ablation 107 Yes 43450 Dilate esophagus 1/mult pass 77 Yes 43453 Dilate esophagus 87 Yes 49405 Image cath fluid colxn visc 162 49406 Image cath fluid peri/retro 162 49407 Image cath fluid trns/vgnl 167CMS-1612-FC 294 (5) Recommended PE Inputs Not Used in the Calc ulation of Practice Expense Relative Value

Units In preparing the Direct Practice Expense I nput database for CY 2014, we noted that in some cases, there were recommended inputs in the da tabase that were not us ed in the calculation of the PE RVUs. In cases where inputs are incl uded for a particular service in a particular setting, but that service is not pr iced in that setting, the inputs are not used . In the documentation files for the CY 2014 final rule, we stated, “In previous years, we ha ve displayed recommended inputs even when these inputs are not used in the calculation of the pr actice expense relative value units. We note that we are no longer displa ying such inputs in these public use files since they are not used in the calculation of the practi ce expense relative value units that appear in the

final rule.”

Comment : Some commenters objected to our removing practice expense inputs for

services that were not reviewed for CY 2014. Response : As indicated in the documentation files, the inputs removed were not used in the calculation of the PE RVUs. Therefore, their removal has no impact on the PE RVUs for these services or the payment for services. We remind readers that, from our perspective, the sole purpose of the Direct PE database is to establish PE RVUs. We believe it is more transparent for these inputs to not appear in the Direct Practice Expense Input database when they do not contribute to the PE RVU calculation for the relevant services. iii. Code-Specific Direct PE Inputs We note that we received many comments obj ecting to refinements made based on “CMS clinical review” (including our determination that certain recommended PE inputs were duplicative of others already incl uded with the service), statutor y requirements, or established principles and policies under the PFS. We note that for many of our refinements, the specialtyCMS-1612-FC 295 societies that represent the practitioners who furnish the service objec ted to most of these refinements for the general reasons described ab ove or for the reasons we respond to in the “background and methodology” portion of this sec tion, or stated that they supported the RUC recommended PE inputs. Below, we res pond to comments in which commenters address specific CPT/HCPCS codes and expl ain their objections to our re finements by providing us with new information supporting the inclusion of the it ems and/or times requested. When discussing these refinements, rather than listing all refine ments made for each service, we discuss only the specific refinements for which commenters provi ded supporting information. We indicate the presence of other refinements by noting “among othe r refinements” after de lineating the specific refinements for a particular service or group of serv ices. For those comments that stated that an item was “necessary for the service” and provide d no additional rationale or information, we

conducted further review to determine whether the inputs as refined were appropriate and concluded that the inputs as refi ned were indeed appropriate. We also note that in many cases, commenters objected to our indicatio n that items were duplicative, stating that they did not know where the duplication existed. In future rulemaking, we do not intend to respond to comments where the commenters dispute th e duplicative nature of inputs unless commenters specifically explain why the relevant items are not duplicativ e with the identical it ems included in a room, kit, pack, or tray. We expect that commenters will review the components of the room, kit, pack, or tray included for that procedure prior to co mmenting that the item is not duplicative. Finally, we note that in some cases we made proposals re lated to comments received in response to the CY 2014 final rule with comment period. In case s where we have addressed the concerns of commenters in the proposed rule, we do not respond to comments here as well. (1) Cross-Family Comments

Comment : We received comments regarding refi nements to equipment times for manyCMS-1612-FC 296 procedures for which commenters indicated that the equipment time for the procedure should include the time that the equipment is unavailab le for other patients, including while preparing equipment, positioning the patient, assisting th e physician, and cleaning the room. Commenters also requested that we indicate which clinical labor tasks should be incl uded in calculating the equipment time for highly technical equipment. Response : As stated above, we agree with comm enters that the equipment time should include the times within the intra-service period when a clinician is using the piece of equipment plus any additional time the piece of equipment is not available for use for another patient due to its use during the designated procedure. We believe that some of these commenters are suggesting that we should allocate the full numbe r of clinical labor mi nutes included in the service period to the equipment items . However, as we have explai ned, the clinical labor service period includes minutes based on so me clinical labor tasks associat ed with pre- and post-service activities that we do not believe typically pr eclude equipment items from being used in furnishing services to other patients because th ese activities typically oc cur in other rooms. The equipment times allocated to the CPT codes in Table 18 already include the full intraservice time the equipment is typically used in furnishing the service, plus additional minutes to reflect time that the equipment is unavailable for use in furnishing services to ot her patients. In response to commenters request for clarification, Table 19 lists the standard clinic al labor tasks to be

included in the calculation of time allocated to hi ghly technical equipment. We note that in some cases, some specialized intraservi ce clinical labor tasks are also included in the equipment time calculations; we have not detailed ev ery possible case in this table.CMS-1612-FC 297 TABLE 18: Equipment Inputs that Include Appropriate Clinical Labor Tasks About Which Comments Were Received CPT Code Equipment Items 70551 EL008 70552 EL008 70553 EL008 93880 EL016 93882 EL016

TABLE 19: Clinical Labor Tasks Included in Calculation of Equipment Time for Highly Technical Equipment.

Clinical Labor Task Prepare room, equipment, supplies Prepare and position patient Assist physician in performing pr ocedure and/or Acquire images Clean room/equipment by physician staff Technologist QC's images in PACS, checking for all images, reformats, and dose page

Comment : We received comments regarding refine ments to clinical labor times for several procedures, in which commenters indicate d that CMS reduced the clinical labor minutes inappropriately for tasks related to film input s, since the recommended minutes were based on the PEAC surveyed times. Tasks included “Process images, complete data sheet, present images and data to the interpreting physician” and “R etrieve prior appropria te imaging exams.” Response : The surveyed times referenced by the commenters refer to the clinical labor tasks associated with film technolog y. In reviewing the times associ ated with these clinical labor tasks, we noted that it would be consistent with our policy finalized in this rule to adjust the

times associated with clinical la bor tasks for all interim final code s to be consistent with the RUC recommendations regarding clinical labor ta sks for digital technology. We are making the associated changes and holding these direct PE inputs interim final for 2015. These clinical labor tasks associated with film and digital i nputs are presented side-by-side, along with the range of typical times, in Table 20. The specifi c interim final codes and their time changes areCMS-1612-FC 298

listed in Table 21.

TABLE 20: Clinical Labor Tasks A ssociated with Digital Technology

Service Period Clinical Labor Task: Film Inputs Typical Minutes Clinical Labor Task: Digital Inputs Typical Minutes

PreService Retrieve prior appropriate imaging exams and hang for MD review, verify orders, review the chart to incorporate relevant clinical information and

confirm contrast protocol with interpreting MD / Retrieve Prior Image for Comparison 4 to 7 Availability of prior images confirmed 2

Patient clinical information and questionnaire reviewed by technologist, order from physician confirmed and exam protocoled by radiologist 2

Service Period:

PostService Process Images, complete data sheet, present images and data to the interpreting physician / Process films, hang films and review study with interpreting MD prior to patient discharge 4 to 20 Technologist QC's images in PACS, checking for all images, reformats, and dose page 2

Review examination with interpreting MD 2 Exam documents scanned into PACS. Exam completed in RIS system to generate billing process and to populate images into Radiologist work queue 1CMS-1612-FC 299 TABLE 21: Interim Final Codes with Adjust ed Clinical Labor Times Due to Filmto-Digital Migration

CPT Code CMS Code Total Film Task Time (2014) Total Digital

Task Time Time Change

19081 L043A 8 9 1 19082 L043A 5 5 0 19083 L051B 8 9 1 19084 L051B 5 5* 0 19085 L047A 8 9 1 19086 L047A 5 5* 0 19281 L043A 8 9 1 19282 L043A 5 5* 0 19283 L043A 8 9 1 19284 L043A 5 5* 0 19285 L051B 8 9 1 19286 L051B 5 5* 0 19287 L047A 8 9 1 19288 L047A 5 5* 0 19281 L043A 5 5 0 19282 L043A 5 5 0 70450 L046A 10 9 -1 70460 L046A 11 9 -2 70470 L046A 13 9 -4 70551 L047A 6 9 2 70552 L047A 8 9 0 70553 L047A 8 9 0 72141 L047A 14 9 -5 72142 L047A 16 9 -7 72156 L047A 18 9 -9 72146 L047A 14 9 -5 72147 L047A 16 9 -7 72157 L047A 18 9 -9 72148 L047A 14 9 -5 72149 L047A 16 9 -7 72158 L047A 18 9 -9 74174 L046A 27 9 -22 *Add-on codes are allocated fewer minutes for these activities. (2) Code-Specific Comments (a) Destruction of Premalignant Lesions (CPT Codes 17000, 17003, 17004) In establishing interim final direct PE inputs for CY 2014, CMS accepted the RUC’sCMS-1612-FC 300 recommendations for supply item LMX 4% anesthetic cream (SH092).

Comment : Commenters indicated that the quan tity of cream units in CPT code 17003 created a rank order anomaly with CPT c odes 17000 and 17004, and that the inclusion of 3 grams was incorrect. Instead, 1 gram should have been included in CPT code 17003. Response : We agree with the commenters that the quantity of SH092 in 17003 should be 1 gram. However, we also note that CPT code 17000 should also co ntain a quantity of 1 gram in order to avoid the rank order anomaly. After c onsideration of the comments received, we are finalizing the CY 2014 interim final dire ct PE inputs for CPT codes 17000, 17003, and 17004, with the additional refinement of changing the quantity of SH092 to 1 for CPT codes 17000 and

17003. (b) Breast Biopsy (CPT Codes 19081, 19082, 19083, 19084, 19085, 19086, 19281, 19282, 19283, 19284, 19285, 19286, 19287, and 19288) In establishing interim final direct PE inputs for CY 2014, CMS refined the RUC’s recommendations for CPT codes 19085, 19086, 19287, and 19288 by removing several new PE inputs, including items called “20MM handpiece—MR,’’ ‘‘vacuum line assembly,’’ ‘‘introducer localization set (trocar),’’ and ‘‘tissue filter,’’ since we concluded that these items served redundant clinical purposes with ot her biopsy supplies already include d in the PE inputs for these codes. We also removed three new equipment items, described as ‘‘breast biopsy software,’’ ‘‘breast biopsy device (coil),’’ and “lateral grid,” because we dete rmined that these items served

clinical functions to items alre ady included in the MR room.

Comment : Commenters indicated that the vacuum assisted breast biopsy requires an assisted biopsy needle system, and tubing must be run from the biopsy device to the biopsy control unit. Commenters also discussed supply items “introducer locali zation set (trocar)” and “tissue filter,” stating that the trocar is used to target the biopsy on the correct lesion, and theCMS-1612-FC 301 tissue filter is necessary to remove the collected core samples from the collection chamber. Commenters described the importance of the “bre ast biopsy device (coil) ,” which is used to move one breast out of the way and the “breast bi opsy software,” which is required to make the necessary calculations to target and biopsy the lesions. Finally, commenters stated that the lateral grid is necessary to place the trocar correctly. Response : The equipment item “breast biopsy device w-system (Mammotome)” (EQ074) is described as “an all-in-one platform designe d for use under ultrasound, MRI, stereotactic and 3D image guidance” and is used with supply item “Mammotome probe” (SD094). Therefore, the supply items “20 MM ha ndpiece, ” “vacuum line assembly,” “tissue filter,” and “trocar,” are duplicativ e of items already included in this procedure. We do note that we have used the invoice to create a price fo r equipment item “Breast biopsy device (coil)” (EQ371) at a price of $12,238. Afte r consideration of the comments received, we are finalizing the CY 2014 interim final direct PE inputs for CPT codes 19085, 19086, 19287, and 19288 as

established with the additional refinement of incorporating the equipment item “Breast biopsy device (coil)” (EQ371).

Comment : A commenter noted that the new brea st biopsy codes do not distinguish between the type of biopsy device used for the procedure, and that the cost of using the vacuumassisted biopsy device (incl uding a Mammotome probe, a Mammo tome probe guide, and tubing and vacuum for the Mammotome device) is nearly eight times the cost of the equipment and supplies required to perform a standard (mechan ical) core needle biops y. The commenter noted that vacuum-assisted biopsy devices are predom inantly used in stereotactic and MRI-guided breast biopsy procedures and 50 percent of the time in ultrasound-guided breast biopsy procedures. Response : For a discussion about the change in coding, we refer readers to section II.F.CMS-1612-FC 302

of this final rule with comment period, where we finalize the work RVUs for interim final 2014 codes. With regard to the direct PE inputs for these services, we note that we include direct PE inputs based on the typical case, and since, as the commenter points out , the vacuum-assisted biopsy devices are typically used, we incl ude these items as direct PE inputs. In reviewing the breast biopsy codes, we not ed that we inadverten tly included supply and equipment items related to breast biopsies in CPT codes 19283, 19284, 19285, 19286, 19087, and 19088, which are procedures that describe the placement of a localization device, not a biopsy. We will therefore remove the items listed in Table 22, which are currently included as direct PE inputs for these procedures. After c onsideration of the comments received, we are finalizing the CY 2014 interim final di rect PE inputs for CPT codes 19081, 19082, 19083, 19084, 19085, 19086, 19281, 19282, 19283, 19284, 19285, 19286, 19287, and 19288 as established, with the additional refinements noted above.

TABLE 22: Supply and Equipment Items Inadvert ently Included in Localization Device Placement Breast Biopsy Codes CPT SD034 SC022 EQ074 19283 X X 19284 X X 19285 X 19286 X 19087 X X X 19088 X X X

(c) Nasal/Sinus Endoscopy (CPT Codes 31237, 31238) In establishing interim final direct PE inputs for CY 2014, CMS refined the RUC’s recommendations for CPT codes 31237 and 31238 by re fining the nurse ble nd (L037D) clinical labor time associated with task “Monitor pt. fo llowing service/check tubes, monitors, drains”

from 15 minutes to 5 minutes.

Comment : Commenters stated that CMS should main tain consistency in the direct PECMS-1612-FC 303 inputs across services by allocating the standa rd 15 minutes for every hour of post-procedure monitoring time. Commenters indi cated that monitoring after these procedures is critical, since the risk of recurrent bleeding is high and patients may become lightheaded. Response : There are two types of post-procedure monitoring time; a standard 15 minutes per hour of post-procedure monito ring time for moderate sedation, a nd a standard 15 minutes per hour of post-procedure monitoring time unrelat ed to moderate sedation. We understand the commenter’s position to mean that there is 60 minutes of post-procedur e monitoring required for these services (in accordance w ith the 15 minutes of RN time per 60 minutes of monitoring). Because these procedures previously included 5 minutes of post-procedure monitoring time, we

do not have a reason to believe that the mon itoring time would have increased by 55 minutes. Should commenters believe this is the case, we invite commenters to provide information to justify this change. In cases where the sp ecialty society is reco mmending post-procedure monitoring unrelated to modera te sedation, it is important th at the recommendation clearly indicates the reason for the monitoring and the re lationship between the clinical staff time and the monitoring time. After consideration of th e comments received, we are finalizing the CY 2014 interim final direct PE inputs for CPT codes 31237 and 31238 as established. (d) Implantation and Removal of Patient Acti vated Cardiac Event Recorder (CPT Codes 33282 and 33284) In the CY 2013 final rule with comment pe riod, in response to nomination of CPT codes 33282 and 33284 as potentially misvalued codes, we indicated that we did not consider the absence of pricing in a particular setting as an indicator of potentially misvalued codes. However, we requested that the RUC review these codes, including the work RVUs, for appropriate nonfacility and facility inputs.CMS-1612-FC 304

Comment : A commenter expressed disappointment that CMS did not price these services in the nonfacility setting but did not pr ovide further informati on about this decision. Response : We received recommendations from the RUC for CPT codes 33282 and

33284 that did not include nonfacili ty inputs. Stakeholders w ho are interested in providing information about the direct PE inputs used in furnishing these services are welcome to submit this information to us; informa tion about the level of informa tion we seek is available to stakeholders in the sample PE worksheet av ailable on the CMS website under downloads at http://www.cms.gov/PhysicianFeeSched/PFSFRN/list.asp#TopOfPage . We encourage

commenters to submit the best data available on the appropriate inputs for these services. (e) Transcatheter Placement of Intr avascular Stent (CPT Codes 37236, 37237) In establishing interim final direct PE inputs for CY 2014, CMS refined the RUC’s recommendations for CPT codes 37236 and 37237 by including supply item “catheter, balloon, PTA” (SD152) as a proxy for “balloon expandable” because we believed that was an appropriate proxy. The invoices provided with the recomme ndation did not indicate the items on the PE worksheet with which they were associated.

Comment : The specialty society representing pract itioners who furnish these services

indicated that the item “balloon expandable” actually referred to a “balloon implantable stent,” and that the invoices provided were associated with that item. Response : We acknowledge the specialty so ciety’s clarification of the RUC recommendation. We will add item “balloon impl antable stent” at a price of $1,500, and remove the proxy item SD152. We note that when line ite ms on the invoices provided are not clearly labeled, it is often difficult for us to determine how to relate the items on the PE spreadsheet with the items on the invoices. For specialty societies to ensure that the requested items are considered for inclusion in the relevant procedure codes, it is important that invoices accompany the RUCCMS-1612-FC 305

recommendations and the line items associated with items on the PE spreadsheet are clearly

labeled.

After consideration of the comments received, we are finalizing the CY 2014 interim final direct PE inputs for CPT codes 37236 a nd 37237 as established with the additional refinement of including “balloon implantable stent” and removing “catheter, balloon, PTA” (SD152). (f) Esophagoscopy (CPT Codes 43197 and 43198) In establishing interim final direct PE inputs for CY 2014, CMS refined the RUC’s

recommendations for CPT codes 43197 and 43198 to remove the Medical/Technical Assistant (L026A) time associated with clinic al labor task “Clean Surgical Instrument Package,” since no surgical instrument package is included in the service, and to remove the endoscopic biopsy forceps (SD066) from CPT code 43198, among other refinements.

Comment : Commenters acknowledged that the pr ocedure did not contain a surgical instrument package, but stated that the time was still necessary for cleaning equipment, such as the nasal speculum, bayonette forceps, and biopsy forceps. Response : In general, as a matte r of relativity th roughout the PFS, the time allocated for

the standard clinical labor task “Clean room /equipment following procedure” encompasses time for cleaning all equipment items. The only excepti ons to this rule are for equipment items that are tied to specific clinical labor tasks, such as cleaning the surgical inst rument pack or cleaning a scope. We do not believe it would serve relativity to separately break out time to clean various different types of equipment. For the biopsy forceps, we indicated in th e final rule with comment period that the

information included with the RUC recommenda tion suggested that the biopsy forceps was reusable (as suggested by the cleaning time men tioned in this comment). As such, we haveCMS-1612-FC 306 created a new equipment item based on the i nvoice provided with th e recommendation and assigned 46 minutes to this equipment item. Howe ver, since we did not receive a paid invoice with this item, we will price it at $0 until we rece ive a paid invoice.

After consideration of the comments received, we are finalizing the CY 2014 interim final direct PE inputs for CPT codes 43197 a nd 43198 as established, with the additional refinement of including 46 minutes for the reusable biopsy forceps. (g) Esophagoscopy/Esophagoscopy Gastrosc opy Duodenoscopy (EGD) (CPT Codes 43200, 43201. 43202, 43206, 43215, 43216, 43217, 43220, 43226, 43227, 43231, 43232, 43235, 43236, 43239, 43245, 43247, 43248, 43248, 43250, 43251, 43252, 43255, 43270) In establishing interim final direct PE inputs for CY 2014, CMS refined the RUC’s recommendations for CPT codes 43200, 43201. 43202, 43206, 43215, 43216, 43217, 43220, 43226, 43227, 43231, 43232, 43235, 43236, 43239, 43245, 43247, 43248, 43248, 43250, 43251, 43252, 43255, and 43270 by refining the quantity of item “canister, suction” (SD009) from 2 to

1.

Comment : Commenters indicated that, for patient safety reasons, one suction canister is needed for the mouth, and another for the scope fo r patient safety reasons. Other stakeholders, specifically, several specialty so cieties with whom we met during the comment period, informed

us that one suction canister is suffi cient and typical for these services. Response : We are persuaded by the information provided by the medical specialty societies during the comment period who indicated that one suction cani ster is typical. In establishing interim final direct PE inputs for CY 2014, CMS refined the RUC’s recommendations for CPT codes 43201 by remo ving needle, micropigmentation (tattoo) (SC079), as the needle require d for this procedure needs to go through an endoscope, and no invoice was provided for this item.CMS-1612-FC 307

Comment : Commenters indicated that the tattoo need le was required to mark the site for injection. Response : We did not receive an invoice for the ta ttoo needle and have no information

about this item. We are also unable to include this item in the PE calculations without a method to price it. We do not believe that we have a reasonable proxy at this time. If we receive invoices for this item, we will be able to include it in the direct PE input database. In establishing interim final direct PE inputs for CY 2014, CMS refined the RUC’s recommendations for CPT codes 43201, 43220, 43226, and 43231 by removing supply item “cup, biopsy-specimen non-sterile 4oz” (SL035).

Comment : Commenters indicated that the endos copy base code, 43200, is included in all of these procedures. Since the biopsy cup is included in the endoscopy base code, it should be

included for these codes as well. Response : We agree with commenters that it is a ppropriate to include this supply item for these procedures. We will incl ude the supply item “cup, biopsy-sp ecimen non-sterile 4oz” in the direct PE inputs for these procedures. In establishing interim final direct PE inputs for CY 2014, CMS refined the RUC’s recommendations for CPT code 43220 by substituting supply item “SD019” as a proxy for

“SD025.”

Comment : Commenters requested that we in clude “endoscopic balloon, dilation” (SD287) rather than a proxy, as this supply item is now included in the database. Response : After receiving cl arification regarding this reque st, we agree with commenters that SD287 is an appropriate supply input for this procedure. Therefor e, we will include SD287

for CPT code 43220. In establishing interim final direct PE inputs for CY 2014, CMS refined the RUC’sCMS-1612-FC 308 recommendations for CPT codes 43220, 43249, and 43270 by removing supply item “guidewire, STIFF” (SD090), among other refinements.

Comment : Commenters indicated that the guidewire is required to safely straddle tumors for which there is impaired visibility and an inability to pass the scope through. Response : We agree with commenters that it w ould be appropriate to include supply item “guidewire – STIFF” in these procedures. We will include the supply item “guidewire – STIFF” in the direct PE inputs for these procedures.

After consideration of the comments received, we are finalizing the CY 2014 interim final direct PE inputs for codes 43200, 43201. 43202, 43206, 43215, 43216, 43217, 43220, 43226, 43227, 43231, 43232, 43235, 43236, 43239, 43245, 43247, 43248, 43248, 43250, 43251, 43252, 43255, and 43270 as established, with the addi tional refinements of including the supply

items noted above. (h) Dilation of Esophagus (CPT Codes 43450, 43453) In establishing interim final direct PE inputs for CY 2014, CMS refined the RUC’s recommendations for CPT codes 43450 and 43453 by removing equipment item “endoscope disinfector, rigid or fiberoptic , w-cart” (ES005), and not creating a new item “mobile stand, vital signs monitor,” and other refinements.

Comment : Commenters stated that the endoscope di sinfector is a necessary part of all endoscopic procedures for sanitary and safety re asons, and that it should be restored for all gastrointestinal endoscopy codes. Commenters also noted that the mobile stand is the standard method of monitoring that must be moved along with the patient. Response : Since these are non-endoscopic dilation codes, there is no scope to clean, and thus the endoscope disinfector is unnecessary. The standard inputs for moderate sedation as recommended by the RUC were included in this pr ocedure; the mobile stand overlaps with theCMS-1612-FC 309 standard moderate sedation input items. After consideration of the comments received, we are finalizing the CY 2014 interim final direct PE inputs for codes CPT codes 43450 and 43453 as

established. (i) Spinal Injections (CPT Codes 62310, 62311, 62318, 62319) In establishing interim final direct PE inputs for CY 2014, CMS accepted the RUC recommendations for CPT codes 62310, 62311, 62318, and 62319. Based on comments received, we made a proposal to maintain the CY 2014 direct PE inputs for CY 2015 while the codes are reexamined for bundling. We are fina lizing this proposal, so while we acknowledge comments received on these codes, we will not respond to these comments as the interim final inputs to which the comments relate will not be used for 2015. (j) Percutaneous Implantation of Neurostimulator (CPT Code 63650) In establishing interim final direct PE inputs for CY 2014, CMS refined the RUC’s recommendations for CPT code time by removing the time associated with clinical labor task “Clean Surgical Instrument Package” and removing supply item “pack, cleaning, surgical instruments” (SA043) since no surgical instru ment package is included in the service.

Comment : Commenters indicated that clinical staff time is critical for the safety and efficiency of the procedure, and that the surgic al instrument cleaning package is necessary to ensure proper adherence of the electrodes. Response : In general, as a matter of relativity thr oughout the PFS, the time allocated for

the standard clinical labor task “Clean room /equipment following procedure” encompasses time for cleaning all equipment items. The only excepti ons to this rule are for equipment items which are tied to specific clinical labor tasks, such as cleaning the surgical inst rument pack or cleaning a scope. We do not believe it would serve relativity to separately break out time to clean various different types of equipment. After considerat ion of the comments received, we are finalizingCMS-1612-FC 310 the CY 2014 interim final direct PE inputs for CPT code 63650 as established. (k) Chemodenervation (CPT Codes 64616, 64642, 64644, 64646, 64647) In establishing interim final direct PE inputs for CY 2014, CMS refined the RUC’s recommendations for CPT codes 64616, 64642, 64644, 64646, and 64647 by reducing the minutes allocated to “table, exam” (EF023) and re moving the time associated with clinical labor task “Complete botox log,” as well as reducing the L037D time for c linical labor “assist physician performing procedure” for CPT code 64616, among other refinements.

Comment : One commenter opposed our adjusting th e minutes allocated to the exam

table. Commenters stated that the reference code, 64615, included three minut es of clinical labor time for “complete botox log,” and requested that th ey be included since they are in the reference code. One commenter asked whether CMS planne d to remove the minutes from the reference

code as well. Other commenters indicated that as with most injections, it is necessary to document various elements of information for safety purposes. Response : Upon reviewing the time allocated to the exam table, we noted that our standard equipment policy is to allocate the entire service period for equipment that is not highly technical. Therefore, we will allocate minutes for the entire service period for the exam table, as follows: 28 minutes for 64616, 44 minutes for 64642, 49 minutes for 64644, 44 minutes for 64646, and 49 minutes for 64647. We appreciate comm enters pointing out the three minutes of time inadvertently allocated for “complete bo tox log” in the reference code, 64615, and will consider this issue in future rulemaking. We not e that one of the benefits of having information

stored in the direct PE database at the clinical labor task level is that it allows us to make comparisons of codes under review to existing codes in the PE database. This will help us ensure greater consistency in our refinements. As commenters point out, various injections are documented in logs, rather than medical reco rds. The use of a different location forCMS-1612-FC 311

documentation is not a reason to allocate additional clinical labor time for a particular service.

Comment : One commenter supported our adjustment of “assist physician” time from 7 minutes to 5 minutes. Another commenter disagr eed with the refinement and requested that CMS explain how physician time was calculated, while a different commenter stated that the “assist physician” time should be 28 minutes. Response : Upon reviewing the work time and the tim e allocated for assist physician, we determined that 7 minutes is actually a ppropriate for the assist physician task.

After consideration of the co mments received, we are finalizing the CY 2014 interim final direct PE inputs for CPT codes 64616, 64642, 64644, 64646, and 64647 as established, with the additional refinement of adjusting the minut es for the exam table as indicated above and adding 2 minutes of clinical labor fo r the “assist physician” task for 64616. (l) MRI Brain (CPT Codes 70551, 70552, 70553) In establishing interim final direct PE inputs for CY 2014, CMS refined the RUC’s recommendations for CPT codes 70551, 70552, and 70553 by adjusting the time for clinical labor task “assist physician in performing procedure/acquire images,” removing 2 minutes of

clinical labor time for clinical labor task “esco rt patient from exam room due to magnetic sensitivity,” removing supply items “gauze,sterile 2in x 2in” (SG053), “tape, phix strips (for nasal catheter)” (SG089), “povidone swabsticks (3 pack uou” (SJ043), and “swab-pad, alcohol” (SJ 053) from CPT codes 70552 and 70553, among other refinements.

Comment : Commenters indicated that the times a ssociated with clinical labor task “assist physician in performing procedure/acquire images” reflected the PEAC surveyed times, and they had no reason to believe that the time had decreased since the PEAC review. Response : As indicated in the PFS CY 2014 final rule with comment period (78 FR 74345), the procedure time for these services wa s last reviewed in 2002. We noted that weCMS-1612-FC 312 believe there should be no signifi cant difference between the time to acquire images for an MRI of the brain and an MRI of the sp ine, and that, rather than rely on very old survey data, it would be appropriate to crosswalk the time associated with the MRI of the sp ine to the MRI of the

brain. We continue to believe that this time is more accurate than that of the survey data.

Comment : Commenters noted that the clinical labor task “escort patient from exam room due to magnetic sensitivity” is a n ecessary activity for patient safety. Response : Upon review of this clinical labor task, we noted that this task was included in the PE worksheets from when these codes were pr eviously reviewed in 2002. Therefore, since this activity does not reflect a newl y added clinical labor task, we agree with commenters that it would be appropriate to include 2 mi nutes for this clinical labor task.

Comment : Commenters stated that the s upplies removed from CPT codes 70552 and 70553 were necessary supplies for the service, and that the specialty society incorrectly included supply item “tape, phix strips (for nasal catheter)” (SG089), wh en the correct s upply item was “tape, surgical paper 1in (Micropore)” (SG079). Response : We note that these supplies were removed because they were already contained in the supply item “kit, IV starter” (SA019). Table 23 shows the items contained in

the IV starter kit and th e corresponding supply items removed due to redundancy.CMS-1612-FC 313 TABLE 23: Items Removed for Redundancy and Pa rallel Items Included in IV Starter Kit Items in IV starter kit Corresponding Items Removed for Redundancy 1 tourniquet - 1 PVP ointment povidone swabsticks (3 pack uou) 1 PVP prep pad swab-pad, alcohol 2 gauze sponges gauze, sterile 2in x 2in 1 bandage (1"x3") - 1 sm roll surgical tape tape, surgical paper 1in 1 pr gloves - 1 underpad 2ft x 3ft (Chux) -

After consideration of the comments received, we are finalizing the CY 2014 interim final direct PE inputs for CPT codes 70551, 70552, and 70553, with the additional refinement of including 2 minutes of clini cal labor time as noted above. (m) MRI Spine (CPT Codes 72141, 72142, 72146, 72147, 72149, 72156, 72157, 72158) In establishing interim final direct PE inputs for CY 2014, CMS refined the RUC’s recommendations for CPT codes 72141, 72142, 72146, 72147, 72149, 72156, 72157, and 72158 by removing 2 minutes of clinical labor time for c linical labor task “escort patient from exam room due to magnetic sensitivity,” and other refinements.

Comment : Commenters noted that the clinical labor task “escort patient from exam room due to magnetic sensitivity” is a n ecessary activity for patient safety. Response : Upon review of this clinical labor task, we noted that this task was included in the PE worksheets from when these codes were pr eviously reviewed in 2002. Therefore, since this activity does not reflect a newl y added clinical labor task, we agree with commenters that it would be appropriate to include 2 mi nutes for this clinical labor task.

Comment : A commenter noted that CMS did not in clude a contrast imaging pack, which includes supplies necessary for contrast enhanced studies.CMS-1612-FC 314 Response: In section II.B. of this final ru le with comment period, we finalized our policy to add a contrast imaging pack to be used for im aging services with contrast. Therefore, we will include the contrast supply pack (C MS code SA114) for CPT codes 72142, 74147, 72149, 72156, 72157, and 72158.

After consideration of the comments received, we are finalizing the CY 2014 interim final direct PE inputs for CPT codes 72141, 72142, 72146, 72147, 72149, 72156, 72157, and 72158, with the additional refinement of including 2 minutes of clinical labor time and including the supply pack for the services noted above. (n) Selective Catheter Placement (CPT Code 75726) In establishing interim final direct PE inputs for CY 2014, when reviewing CPT code 36245, which was identified through a misvalued code screen of codes reported together more than 75 percent of the time, we noted that it was frequently billed with 75726. We then noted that

these two services had identical time for “assistphysician in performing procedure,” and since

the time for 36245 was reduced from 73 to 45 mi nutes, refined the clinical labor time for 75726 to correspond to this change.

Comment : Commenters indicated that the 73 minutes reflected the PEAC surveyed times, and that these activities are imaging-re lated, and in addition to the time and activities inherent in the accompanying surgical base code. Response : As indicated elsewhere in this section, we note that the PEAC survey data are very old, and that refinements based on more upda ted information are appropriate. We continue to believe that it is appropriate for the in traservice times for 36245 and 75726 to continue to correspond to one another, as they are frequently furnished together. Afte r consideration of the comments received, we are finalizing the CY 2014 interim final direct PE inputs for CPT code

75726 as established.CMS-1612-FC 315 (o) Radiation Treatment De livery (CPT Codes 77373, 77422, 77423) In establishing interim final direct PE inputs for CY 2014, CMS refined the RUC’s recommendations for CPT code 77373 by refining th e equipment time for “pulse oximeter wprinter” (EQ211) and “SRS system, SBRT, si x systems, average” (ER083) to conform to established equipment policies.

Comment : Commenters stated that the times should be maintained at 104 minutes, rather than being reduced to 86 minutes , and indicated the clinical labor task lines that should be

included in the calculations. Response : Upon reviewing the equipment times associ ated with this procedure, we agree

with commenters that the time allocated for the equipment should include the time associated

with the indicated clinical labor tasks for th ese equipment items. Afte r consideration of the comments received, we are finalizing the CY 2014 interim final direct PE inputs for CPT code 77373 as established, with the additional refinement of adjusting the equipment times to 104

minutes as noted above. For CY 2014, we also eliminated several a nomalous supply inputs included in the direct PE database, which affected 77422 and 77423, among other services.

Comment : Commenters indicated that upon review ing the inputs for these services, they noted that the Record and Verify System and th e laser targeting system were missing in both of these services, despite being in the original 2005 recommendation. Response : We appreciate the commenters’ attenti on to detail. However, as indicated elsewhere, we do not believe that the record an d verify system is medical equipment used in furnishing the technical component of the service. We refer readers to our discussion of this

issue in the PFS 2014 Final rule with Comment period (78 FR 74317). Further, since these codes have not been reviewed in many years, we do not know if the la ser targeting systemCMS-1612-FC 316 continues to be an appropriate input for these services. Therefore, we request that the RUC examine the inputs for these servic es to ensure their accuracy. (p) Hyperthermia (CPT Code 77600) In establishing interim final direct PE inputs for CY 2014, CMS refined the RUC’s recommendations for CPT code 77600 by refining the time allocated to equipment item “hyperthermia system, ultrasound, external” (ER0 35) and removing the time associated with

clinical labor task “clean scope,” among other refinements.

Comment : Commenters indicated that the appropri ate lines were not used to calculate the recommended equipment times, includi ng cleaning the scope and check dressing. Response : Upon reviewing the comments, we re-examined the equipment time

calculation and continue to believe that the time a llocated to this equipment item is appropriate. We note that there is no scope used in this proced ure, so time to clean the scope is unnecessary.

After consideration of the commen ts received, we are finalizing the CY 2014 interim final direct PE inputs for CPT code 77600 as established. (q) High Dose Rate Brachytherapy (CPT Codes 77785, 77586, 77787) In establishing interim final direct PE inputs for CY 2014, CMS refined the RUC’s recommendations for CPT codes 77785, 77786, and 77787 to remove “Emergency service container – safety kit,” as we consider it an indirect PE.

Comment : Commenters noted that the emergency c ontainer is a safety device used when a source must be retrieved manually. Commenters in dicated that it is a mob ile item and that the service cannot be provided unless it is in the room, and thus it is a direct PE, since it is directly assumed by a physician in the course of providing the service. Commen ters asked that we reclassify this item as a direct input.CMS-1612-FC 317 Response : In our clinical review, we reviewed the work vignettes for these procedures, which did not include the use of the “emergency serv ice container - safety kit” as a part of the procedure. Although we acknowledge that the emer gency service container safety kit needs to be readily available during the procedure, we not e that “standby” equipment, or items that are not used in the typical case, are considered indirect costs. For further discussion of this issue, we refer readers to our discussion of “standby” equi pment in the CY 2001 PFS proposed rule (65 FR 44187). When reviewing the interim final direct PE inputs for these servic es, we noted that the specialty societies conducted a survey of the te chnicians, which revealed higher procedure times than the current procedure times. However, si nce the RUC indicated th at they did not have “compelling evidence,” the specialty society did not request the higher procedure times. We believe that if the specialty society believes that the code is undervalued relative to the expert panel value, and there is no indi cation that the survey was flaw ed, the specialty society should recommend the use of the surveyed procedure tim es. In doing so, the specialty society would give CMS the opportunity to consider th e information provided alongside the RUC recommended times. We believe that surveys of technicians have the potential to be more accurate, rather than less accura te, than those of physicians, as the technicians do not have incentives to increase the surveyed time. We sugg est that rather than attempting to insert items

that are not standard in the PE methodology, that specialty soci eties make a strong, data-driven case, for why the survey times are correct.

Comment: A commenter noted that there have been significant re ductions to these CPT codes over the last several years, and urged CMS to phase in the reductions over time should the reductions be deemed appropriate afte r review of the methodology and data.CMS-1612-FC 318 Response : We note that reductions to CPT codes are made on the basis that they are potentially misvalued. We do not typically tran sition such reductions. However, the Protecting Access to Medicare Act (PAMA) requires that beginning in 2017, CMS transition code-level reductions of greater than or equal to 20 percent in a given year; therefore, beginning in 2017,

such reductions will be transitioned.

After consideration of the comments received, we are finalizing the CY 2014 interim final direct PE inputs for CPT c odes 77785, 77786, and 77787 as established. (r) Cytopathology (CPT Code 88112) In establishing interim final direct PE inputs for CY 2014, CMS refined the RUC’s recommendations for CPT code 88112 by removing th e clinical labor time associated with several clinical labor tasks, in cluding “Order, restock, and distri bute specimen containers with requisition forms,” “Perform screening function (where applicable),” “Confirm patient ID, organize work, verify and revi ew history,” and “Enter screen ing diagnosis in laboratory information system, complete workload record ing logs, manage any relevant utilization review/quality assurance activities and regulat ory compliance documentation and assemble and deliver slides with pape rwork to pathologist.”

Comment : Commenters pointed out that CPT co de 88112 was inadvertently listed in

Table 28 in the CY 2014 final rule with co mment period as being unrefined by CMS. Commenters also opposed the reductions in cl inical labor time, and noted that the PE subcommittee thoroughly reviewed these inputs. Response : We apologize for the inadvertent inclus ion of CPT code 88112 in Table 28 of the CY 2014 final rule with comment period. We re -examined the clinical la bor tasks in light of

the comments received and noted that the clin ical labor task “Order , restock, and distribute specimen containers with requisition forms” is not a clinical labor task associated with furnishingCMS-1612-FC 319 a service to a particular patient , and is therefore allocated in the indirect practice expense. Clinical labor task “Perform screening function (w here applicable)” is not a task completed in the typical service, and is therefore not included. Further, clinical labor task “Confirm patient ID, organize work, verify and review history” is subsumed within clinical labor task “Remove slide from coverslipper; confirm patient ID, organize work, send slides to cytotech for screening”; including both would therefore be duplicative. Clinical labor task “Enter screening diagnosis in laboratory information system, complete work load recording logs, manage any relevant utilization review/quality assurance activities and regulatory compliance documentation and assemble and deliver slides with paperwork to pathologist” involves quality assurance activities.

We refer readers to the CY 2014 PFS final ru le with comment period (78 FR 74308) for a discussion regarding quality assura nce activities. After considerat ion of the comments received, we are finalizing the CY 2014 interim fi nal direct PE inputs for CPT code 88112.

Comment : One commenter noted that the refineme nts to the PE inputs for CPT code 88112 resulted in a rank-order anomaly, as CPT code 88108 has higher PE RVUs than CPT code 88112, while CPT code 88108 is a less complex se rvice than CPT code 88112. Specifically, commenters stated that it is illogical for a cy tology specimen processing technique that involves an additional step that requires ma terially more resources to have an RVU that is less than an associated technique that require s fewer resources, and expresse d concerns about the potential for misreporting. Response : We appreciate this commenter bringi ng this rank order anomaly to our

attention. As indicated in secti on II.B. of this final rule with comment period, we are referring this code to the RUC as potentially misval ued based on the information received from the

commenter. (s) Duplex Scans (CPT Codes 93880 and 93882)CMS-1612-FC 320 In establishing interim final direct PE inputs for CY 2014, CMS refined the RUC’s recommendations for CPT codes 93880 and 93882 by removing the equipment time allocated for equipment items “video SVHS VCR (medical gr ade)” (ED034) and “video printer, color (Sony medical grade)” (ED036), and refining the equipment time for “computer desktop, w-monitor” (ED021) from 68 to 51 minutes, among other refinements.

Comment : Commenters indicated that these items are not redundant and asked that CMS explain which items encompass ED034 and ED036. Commenters also stated that the desktop computer is used for the entire intraservice peri od. Commenters also stated that the refinements were expressed as a final d ecision effective January 1, 2014. Response : The equipment item “room, vascular ultrasound” (EL016) contains “room, ultrasound general” (EL015), which contains bot h “video SVHS VCR (medical grade)” and “digital printer (Sony UPD21).” We also note that the RUC has reviewed these codes again for 2015; we refer readers to secti on II.F. of this rule for furt her discussion, including the new interim final inputs established for 2015. We further note that contrary to the commenters’ assertion, the refinements made were indeed effective January 1, 2014, but were not final decisions; rather, they were interim fina l for 2014 and subject to public comment. (t) Electroencephalogram (CPT Codes 95816, 95819, 95822) In establishing interim final direct PE inputs for CY 2014, CMS refined the RUC’s recommendations for CPT codes 95816, 95819, and 95822 by refining the equipment time allocated to equipment item “EEG, digital, te sting system (computer hardware, software & camera)” (EQ330), among other refinements.

Comment : Commenters indicated that various staff activities are performed on the computer and requested that we re store the time previously removed.CMS-1612-FC 321 Response : Upon reviewing comments regarding the equipment time, we agree with

commenters that we should allocate the entire service period for EQ330, since it is not highly technical equipment. After consideration of the comments received, we are finalizing the CY 2014 interim final direct PE inputs for CP T codes 95816, 95819, and 95822 as established, with the additional refinement of assigni ng the intraservice time to EQ330. (u) Anogenital Examination With Colposcopi c Magnification in Childhood for Suspected Trauma (CPT Code 99170) In establishing interim final direct PE inputs for CY 2014, CMS refined the RUC’s recommendations for CPT codes, we accepted the RUC’s recommendation to include a new clinical labor type called “child life specialist.”

Comment: One commenter supported the inclusion of clinical labor staff time for the child life specialist. Response: We appreciate the commenter’s support for this decision. After consideration of the comments received, we are finalizing the CY 2014 interim final direct PE inputs for CPT

code 99170 as established. (v) Immunohistochemistry (H CPCS Codes G0461 and G0462) In establishing interim final direct PE inputs for CY 2014, CMS refined the RUC’s recommendations for CPT codes 88342 and 88343 by creating G-codes G0461 and G0462 and refining the inputs for these se rvices. We acknowledge comments regarding the refinements CMS made to these inputs, as well as comments i ndicating that the direct practice expense inputs for these procedures implied th at the reporting would be differe nt than the reporting implied by the code descriptors. We note that the RU C has subsequently reviewed CPT codes 88342 and 88343 again and we present the interim final valu es for 2015 in this final rule with commentCMS-1612-FC 322 period. Therefore, we will not address specifi c comments regarding G0461 and G0462 except, as discussed below, as they pertain to errors id entified with regard to the pricing of supplies.

Comment : Commenters alerted us to an error in the calculation of the supply price for SL483 and SL486. Commenters pointed out that the price for SL483 is $22.56/ml, rather than the .00256/ml that was listed in the database, and based on the unit of meas ure established in the direct PE inputs database for SL486, which co sts $65.63 for 250 tests, the per test quantity should be 1, rather than 0.004. Response : We agree with commenters that these pr ices were calculat ed incorrectly and have made the adjustments to the direct PE database. c. Finalizing CY 2014 Interim Ma lpractice Crosswalks for CY 2015 In accordance with our malpractice methodology, we adjusted the malpractice RVUs for the CY 2014 new/revised/potentially misvalued code s for the difference in work RVUs (or, if greater, the clinical labo r portion of the PE RVUs) between th e source codes and the new/revised codes to reflect the specific risk-of-service for the new/revised codes. The interim final malpractice crosswalks were listed in Table 30 of the CY 2014 PFS final rule with comment period. We received only one comment on our CY 2014 inte rim final cross walks. As detailed in the CY 2014 final rule with comment period, we assigned malpractice cr osswalk of CPT code 31575 (Laryngoscopy, flexible fiberoptic; diagno stic) to CPT codes 43191-43195 and CPT code 31638 (Bronchoscopy, rigid or flexible, including fl uoroscopic guidance, when performed; with

revision of tracheal or bronchial stent inserted at prev ious session (include s tracheal/bronchial dilation as required)) to CPT code 43196.

Comment: A commenter said that the es tablished PLI crosswalk, CPT code 31575, for CPT code 43191-43196 is not appropriate because the la tter services have a life-threatening riskCMS-1612-FC 323 to patients and the same is not true for CP T code 31575. The commenter recommends instead

that we utilize the RUC recommended crosswalk of bronchoscopy, rigid or flexible codes (CPT codes 31622 (Bronchoscopy, rigid or flexible, incl uding fluoroscopic guidance, when performed; diagnostic, with cell washing, when performe d (separate procedure)) for CPT code 43191, 31625 (Bronchoscopy, rigid or flexible, including fluor oscopic guidance, when performed; with

bronchial or endobronchial bi opsy(s), single or multiple sites) for CPT code 43192, 43193, and 43195, and 31638 (Bronchoscopy, rigid or flexible, including fluoroscopic guidance, when performed; with revision of tracheal or bronchi al stent inserted at pr evious session (includes

tracheal/bronchial dilation as required)) for CPT codes 43194 and 43196. Response: We continue to believe that our as signed CY 2014 malpract ice crosswalks best define the malpractice risk associated with CPT codes 43191-43196. Therefore, we are finalizing

our CY 2014 interim final crosswalks.

We received no comments on the CY 2014 inter im final malpractice crosswalks and are finalizing them without m odification for CY 2015. The malpractice RVUs for these services ar e reflected in Addendum B of this CY 2014 PFS final rule with comment period. Since we are finalizing a five-year review of MP RVUs in this final rule with comment period, the MP RVUs assigned to this codes will also be affected by the updates due to this review. For de tails on the review, see section II.C. d. Other New, Revised or Potentially Misval ued Codes with CY 2014 Interim Final RVUs Not Specifically Discussed in the CY 2015 Final Rule with Comment Period For all other new, revised, or potentially misvalued codes with CY 2014 interim final RVUs that are not specifically discussed in this CY 2015 PFS final rule with comment period, we are finalizing for CY 2015, without modifi cation, the CY 2014 interim final or CY 2014 proposed work RVUs, malpractice crosswalks, and direct PE inputs. Unless otherwise indicated,CMS-1612-FC 324 we agreed with the time values recommended by the RUC or HCPAC for all codes addressed in

this section. The time values fo r all codes are listed in a file called “CY 2014 PFS Work Time,”

available on the CMS website under downloads for the CY 2015 PFS final rule with comment period at http://www.cms.gov/Medicare/M edicare-Fee-for-ServicePayment/PhysicianFeeSched/PFS-Fe deral-Regulation-Notices.html

. 3. Establishing CY 2015 RVUs a. Finalizing CY 2015 Proposed RVUs In the CY 2015 proposed rule, we proposed CY 2015 work values for several codes.

Table 24 contains a list of these codes and the final CY 2015 work RVUs. For more information

on these codes and the establishment of the valu es, see section II.Bof this final rule with comment period.CMS-1612-FC 325 TABLE 24: CY 2015 Final Work RVUS for Codes with Proposed Work RVUs

HCPCS

Code Long Descriptor CY 2014 WRVU Proposed CY 2015

Work RVU CY 2015 Work RVU G0389 Ultrasound, B-scan and/or real time with image documentation; for abdominal aortic aneurysm (AAA) screening 0.58 0.58 0.58

G0416 Surgical pathology, gross and microscopic examination for prostate needle biopsies, any method; 3.09 3.09 3.09

G0473 Face-to-face behavioral counseli ng for obesity, gr oup (2-10), 30 minutes New N/A 0.25

62310 Injection(s), of diagnostic or th erapeutic substance(s) (including anesthetic, antispasmodic, opioid, steroid, other solution), not including neurolytic substances, including needle or catheter placement, includes contrast for localization when performed, epidural or subarachnoid ; cervical or thoracic 1.18 1.91 1.91

62311 Injection(s), of diagnostic or th erapeutic substance(s) (including anesthetic, antispasmodic, opioid, steroid, other solution), not including neurolytic substances, including needle or catheter placement, includes contrast for localization when performed, epidural or subarachnoid; lu mbar or sacral (caudal) 1.17 1.54 1.54

62318 Injection(s), including indwelli ng catheter placement, continuous infusion or intermittent bolus, of diagnostic or therapeutic substance(s) (including anesthetic, antispasmodic, opioid, steroid, other solution), not including neurolytic substances, includes contrast for localization when performed, epidural or subarachnoid; cervical or thoracic) 1.54 2.04 2.04

62319 Injection(s), including indwelli ng catheter placement, continuous infusion or intermittent bolus, of diagnostic or therapeutic substance(s) (including anesthetic, antispasmodic, opioid, steroid, other solution), not including neurolytic substances, includes contrast for localization when performed, epidural or subarachnoid; lumbar or sacral (caudal) 1.50 1.87 1.87

77055 mammography; unilateral, .70 .70 .70 77056 mammography; bilateral .87 .87 .87 77057 screening mammography, bilateral (2-view film study of each breast) .70 .70 .70

99490 Chronic care management services, at least 20 minutes of clinical staff time directed by a physician or other qualified health care professional, per calendar month, with the following required elements: multiple (two or more) chronic conditions expected to last at least 12 months, or until the death of the patient; chronic conditions place the patient at significant risk of death, acute exacerbation/decompen sation, or functional decline; comprehensive care plan established, implemented, revised, or monitored. New .61 .61

b. Establishing CY 2015 Interim Final Work RVUs Table 25 contains the CY 2015 interim final work RVUs for all codes for which we

received RUC recommendations for CY 2015 and G-codes with interim final values for CYCMS-1612-FC 326 2015. These values are subject to public co mment. The column labeled “CMS Time

Refinement” indicates whether CMS refined the time values recommended by the RUC or

HCPAC.

This section discusses codes for which the interim final work RVU or time values assigned for CY 2015 vary from those recommen ded by the RUC or for which we do not have

RUC recommendations.CMS-1612-FC 327

TABLE 25: CY 2015 Interim Final Work RVUS fo r New/Revised or Po tentially Misvalued Codes

HCPCS

Code Long Descriptor CY 2014 WRVU RUC/HCPAC Recommended

Work RVU CY 2015 Work RVU CMS Time Refinement

11980 Subcutaneous hormone pellet implantation (implantation of estradiol and/or testosterone pellets beneath the skin) 1.48 1.10 1.10 No

20604 Arthrocentesis, aspiration and/or injection, small joint or bursa (eg, fingers, toes); with ultrasound guidance, with permanent recording and reporting New 0.89 0.89 No

20606 Arthrocentesis, aspiration and/or injection, intermediate joint or bursa (eg, temporomandibular, acromioclavicular, wrist, el bow or ankle, olecranon bursa); with ultrasound guidance, with permanent recording and reporting New 1.00 1.00 No

20611 Arthrocentesis, aspiration and/or injection, major joint or bursa (eg, shoulder, hip, knee, subacromial bursa); with ultrasound guidance, with permanent recording and reporting New 1.10 1.10 No

20983 Ablation therapy for reduction or eradication of 1 or more bone tumors (eg, metastasis) including adjacent soft tissue wh en involved by tumor extension, percutaneous, including imaging guidance when performed; cryoablation New 7.13 7.13 No

21811 Open treatment of rib fracture(s) with internal fixation, includes thoracoscopic visualization when performed, unilateral; 1-3 ribs New 19.55 10.79 Yes

21812 Open treatment of rib fracture(s) with internal fixation, includes thoracoscopic visualization when performed, unilateral; 4-6 ribs New 25.00 13.00 Yes

21813 Open treatment of rib fracture(s) with internal fixation, includes thoracoscopic visualization when performed, unilateral; 7 or more ribs New 35.00 17.61 Yes

22510 Percutaneous vertebroplasty (bone biopsy included when performed), 1 vertebral body, unilateral or bilateral injection, inclusive of all imaging guidance; cervicothoracic New 8.15 8.15 No

22511 Percutaneous vertebroplasty (bone biopsy included when performed), 1 vertebral body, unilateral or bilateral injection, inclusive of all imaging guidance; lumbosacral New 8.05 7.58 NoCMS-1612-FC 328

HCPCS

Code Long Descriptor CY 2014 WRVU RUC/HCPAC Recommended

Work RVU CY 2015 Work RVU CMS Time Refinement

22512 Percutaneous vertebroplasty (bone biopsy included when performed), 1 vertebral body, unilateral or bilateral injection, inclusive of all imaging guidance; each additional cervicothoracic or lumbosacral vertebral body (list separately in addition to code for primary procedure) New 4.00 4.00 No

22513 Percutaneous vertebral augmentation, including cavity creation (fracture reduction and bone biopsy included when performed) using mechanical device (eg, kyphoplasty), 1 vertebral body, unilateral or bilateral cannulation, inclusive of all imaging guidance; thoracic New 8.90 8.90 No

22514 Percutaneous vertebral augmentation, including cavity creation (fracture reduction and bone biopsy included when performed) using mechanical device (eg, kyphoplasty), 1 vertebral body, unilateral or bilateral cannulation, inclusive of all imaging guidance; lumbar New 8.24 8.24 No

22515 Percutaneous vertebral augmentation, including cavity creation (fracture reduction and bone biopsy included when performed) using mechanical device (eg, kyphoplasty), 1 vertebral body, unilateral or bilateral cannulation, inclusive of all imaging guidance; each additional thoracic or lumbar vertebral body (list separately in addition to code for primary procedure) New 4.00 4.00 No

22856 Total disc arthroplasty (a rtificial disc), anterior approach, including dis cectomy with end plate preparation (includes osteophytectomy for nerve root or spinal cord decompression and microdissection); single interspace, cervical 24.05 24.05 24.05 No

22858 Total disc arthroplasty (a rtificial disc), anterior approach, including dis cectomy with end plate preparation (includes osteophytectomy for nerve root or spinal cord decompression and microdissection); second level, cervical (list separately in addition to code for primary procedure) New 8.40 8.40 No

27279 Arthrodesis, sacroiliac joint, percutaneous or minimally invasive (indirect visualization), with image guidance, includes obtaining bone graft when performed, and placement of transfixing device New 9.03 9.03 No

29200 Strapping; thorax 0.65 0.39 0.39 No 29240 Strapping; shoulder (eg, velpeau) 0.71 0.39 0.39 No 29260 Strapping; elbow or wrist 0.55 0.39 0.39 NoCMS-1612-FC 329

HCPCS

Code Long Descriptor CY 2014 WRVU RUC/HCPAC Recommended

Work RVU CY 2015 Work RVU CMS Time Refinement

29280 Strapping; hand or finger 0.51 0.39 0.39 No 29520 Strapping; hip 0.54 0.39 0.39 No 29530 Strapping; knee 0.57 0.39 0.39 No

31620 Endobronchial ultrasound (ebus) during bronchoscopic diagnostic or therapeutic intervention(s) (list separately in addition to code for primary procedure[s]) 1.40 1.50 1.40 No

33215 Repositioning of previously implanted transvenous pacemaker or implantable defibrillator (right atrial or right ventricular) electrode 4.92 4.92 4.92 No

33216 Insertion of a single transvenous electrode, permanent pacemaker or implantable defibrillator 5.87 5.87 5.87 No

33217 Insertion of 2 transvenous electrodes, permanent pacemaker or implan table defibrillator 5.84 5.84 5.84 No

33218 Repair of single transv enous electrode, permanent pacemaker or implan table defibrillator 6.07 6.07 6.07 No

33220 Repair of 2 transvenous electrodes for permanent pacemaker or implan table defibrillator 6.15 6.15 6.15 No

33223 Relocation of skin po cket for implantable defibrillator 6.55 6.55 6.55 No

33224 Insertion of pacing electrode, cardiac venous system, for left ventricular pacing, with attachment to previously placed pa cemaker or implantable defibrillator pulse generator (including revision of pocket, removal, insertion, and/or replacement of existing generator) 9.04 9.04 9.04 No

33225 Insertion of pacing electrode, cardiac venous system, for left ventricular pacing, at time of insertion of implantable defibrillator or pacemaker pulse generator (eg, for upgrade to dual chamber system) (list separately in addition to code for primary procedure) 8.33 8.33 8.33 No

33240 Insertion of implantable defibrillator pulse generator only; with existing single lead 6.05 6.05 6.05 No

33241 Removal of implantable defibrillator pulse generator only 3.29 3.29 3.29 No

33243 Removal of single or dual chamber implantable defibrillator electrode(s); by thoracotomy 23.57 23.57 23.57 No

33244 Removal of single or dual chamber implantable defibrillator electrode(s); by transvenous extraction 13.99 13.99 13.99 No

33249 Insertion or replacement of permanent implantable defibrillator system, with transvenous lead(s), single or dual chamber 15.17 15.17 15.17 NoCMS-1612-FC 330

HCPCS

Code Long Descriptor CY 2014 WRVU RUC/HCPAC Recommended

Work RVU CY 2015 Work RVU CMS Time Refinement

33262 Removal of implantable defibrillator pulse generator with replacement of implantable defibrillator pulse generator; single lead system 6.06 6.06 6.06 No

33263 Removal of implantable defibrillator pulse generator with replacement of implantable defibrillator pulse generator; dual lead system 6.33 6.33 6.33 No

33270 Insertion or replacement of permanent subcutaneous implantable defibrillator system, with subcutaneous electrode, including defibrillation threshold evaluation, induction of arrhythmia, evaluation of sensing for arrhythmia termination, and programming or reprogramming of sensing or therapeutic parameters, when performed New 9.10 9.10 No

33271 Insertion of subcutaneous implantable defibrillator electrode New 7.50 7.50 No

33272 Removal of subcutaneous implantable defibrillator electrode New 5.42 5.42 No

33273 Repositioning of previously implanted subcutaneous implantable defibrillator electrode New 6.50 6.50 No

33418 Transcatheter mitral valve repair, percutaneous approach, including transseptal puncture when performed; initial prosthesis New 32.25 32.25 No

33419 Transcatheter mitral valve repair, percutaneous approach, including transseptal puncture when performed; additional prosthesis(es) during same session (list separately in addition to code for primary procedure) New 7.93 7.93 No

33946 Extracorporeal membrane oxygenation (ecmo)/extracorporeal life support (ecls) provided by physician; initiation, veno-venous New 6.00 6.00 No

33947 Extracorporeal membrane oxygenation (ecmo)/extracorporeal life support (ecls) provided by physician; initiation, veno-arterial New 6.63 6.63 No

33949 Extracorporeal membrane oxygenation (ecmo)/extracorporeal life support (ecls) providedby physician; daily management, each day, venoarterial New 4.60 4.60 No

33951 Extracorporeal membrane oxygenation (ecmo)/extracorporeal life support (ecls) provided by physician; insertion of peripheral (arterial and/or venous) cannula(e), percutaneous, birth through 5 years of age (includes fluoroscopic guidance, when performed) New 8.15 8.15 NoCMS-1612-FC 331

HCPCS

Code Long Descriptor CY 2014 WRVU RUC/HCPAC Recommended

Work RVU CY 2015 Work RVU CMS Time Refinement

33952 Extracorporeal membrane oxygenation (ecmo)/extracorporeal life support (ecls) provided by physician; insertion of peripheral (arterial and/or venous) cannula(e), percutaneous, 6 years and older (includes fluoroscopic guidance, when performed) New 8.43 8.15 No

33953 Extracorporeal membrane oxygenation (ecmo)/extracorporeal life support (ecls) provided by physician; insertion of peripheral (arterial and/or venous) cannula(e), open, birth through 5 years of age New 9.83 9.11 No

33954 Extracorporeal membrane oxygenation (ecmo)/extracorporeal life support (ecls) provided by physician; insertion of peripheral (arterial and/or venous) cannula(e), open, 6 years and older New 9.43 9.11 No

33955 Extracorporeal membrane oxygenation (ecmo)/extracorporeal life support (ecls) provided by physician; insertion of central cannula(e) by sternotomy or thoracotomy, birth through 5 years of age New 16.00 16.00 No

33956 Extracorporeal membrane oxygenation (ecmo)/extracorporeal life support (ecls) provided by physician; insertion of central cannula(e) by sternotomy or thoracotomy, 6 years and older New 16.00 16.00 No

33957 Extracorporeal membrane oxygenation (ecmo)/extracorporeal life support (ecls) provided by physician; reposition peripheral (arterial and/or venous) cannula(e), percutaneous, birth through 5 years of age (includes fluoroscopic guidance, when performed) New 4.00 3.51 No

33958 Extracorporeal membrane oxygenation (ecmo)/extracorporeal life support (ecls) provided by physician; reposition peripheral (arterial and/or venous) cannula(e), percutaneous, 6 years and older (includes fluoroscopic guidance, when performed) New 4.05 3.51 No

33959 Extracorporeal membrane oxygenation (ecmo)/extracorporeal life support (ecls) provided by physician; reposition peripheral (arterial and/or venous) cannula(e), open, birth through 5 years of age (includes fluoroscopic guidance, when performed) New 4.69 4.47 No

33962 Extracorporeal membrane oxygenation (ecmo)/extracorporeal life support (ecls) provided by physician; reposition peripheral (arterial and/or venous) cannula(e), open, 6 years and older (includes fluoroscopic guidance, when performed) New 4.73 4.47 NoCMS-1612-FC 332

HCPCS

Code Long Descriptor CY 2014 WRVU RUC/HCPAC Recommended

Work RVU CY 2015 Work RVU CMS Time Refinement

33963 Extracorporeal membrane oxygenation (ecmo)/extracorporeal life support (ecls) provided by physician; reposition of central cannula(e) by sternotomy or thoracotomy, birth through 5 years of age (includes fluoroscopic guidance, when performed) New 9.00 9.00 No

33964 Extracorporeal membrane oxygenation (ecmo)/extracorporeal life support (ecls) provided by physician; reposition central cannula(e) by sternotomy or thoracotomy, 6 years and older (includes fluoroscopic guidance, when performed) New 9.50 9.50 No

33965 Extracorporeal membrane oxygenation (ecmo)/extracorporeal life support (ecls) provided by physician; removal of peripheral (arterial and/or venous) cannula(e), percutaneous, birth through 5 years of age New 3.51 3.51 No

33966 Extracorporeal membrane oxygenation (ecmo)/extracorporeal life support (ecls) provided by physician; removal of peripheral (arterial and/or venous) cannula(e), percutaneous, 6 years and older New 4.50 4.50 No

33969 Extracorporeal membrane oxygenation (ecmo)/extracorporeal life support (ecls) provided by physician; removal of peripheral (arterial and/or venous) cannula(e), open, birth through 5 years of age New 6.00 5.22 No

33984 Extracorporeal membrane oxygenation (ecmo)/extracorporeal life support (ecls) provided by physician; removal of peripheral (arterial and/or venous) cannula(e), open, 6 years and older New 6.38 5.46 No

33985 Extracorporeal membrane oxygenation (ecmo)/extracorporeal life support (ecls) provided by physician; removal of central cannula(e) by sternotomy or thoracotomy, birth through 5 years of age New 9.89 9.89 No

33986 Extracorporeal membrane oxygenation (ecmo)/extracorporeal life support (ecls) provided by physician; removal of central cannula(e) by sternotomy or thoracotomy, 6 years and older New 10.00 10.00 No

33987 Arterial exposure with creat ion of graft conduit (eg, chimney graft) to facilitate arterial perfusion for ecmo/ecls (list separately in addition to code for primary procedure) New 4.04 4.04 No

33988 Insertion of left heart vent by thoracic incision (eg, sternotomy, thoracotomy) for ecmo/ecls New 15.00 15.00 NoCMS-1612-FC 333

HCPCS

Code Long Descriptor CY 2014 WRVU RUC/HCPAC Recommended

Work RVU CY 2015 Work RVU CMS Time Refinement

33989 Removal of left heart vent by thoracic incision (eg, sternotomy, thoracotomy) for ecmo/ecls New 9.50 9.50 No

34839 Physician planning of a patient-specific fenestrated visceral aortic endograft requiring a minimum of 90 minutes of physician time New C B N/A

34841 Endovascular repair of visceral aorta (eg, aneurysm, pseudoaneurysm, dissection, penetrating ulcer, intramural hematoma, or traumatic disruption) by deployment of a fenestrated visceral aortic endograft and all associated radiological supervision and interpretation, including target zone angioplasty, when performed; including one visceral artery endoprosthesis (sup erior mesenteric, celiac or renal artery) C C C N/A

34842 Endovascular repair of visceral aorta (eg, aneurysm, pseudoaneurysm, dissection, penetrating ulcer, intramural hematoma, or traumatic disruption) by deployment of a fenestrated visceral aortic endograft and all associated radiological supervision and interpretation, including target zone angioplasty, when performed; including two visceral artery endoprostheses (superior mesenteric, celiac and/or renal artery[s]) C C C N/A

34843 Endovascular repair of visceral aorta (eg, aneurysm, pseudoaneurysm, dissection, penetrating ulcer, intramural hematoma, or traumatic disruption) by deployment of a fenestrated visceral aortic endograft and all associated radiological supervision and interpretation, including target zone angioplasty, when performed; including three visceral artery endoprostheses (superior mesenteric, celiac and/or renal artery[s]) C C C N/A

34844 Endovascular repair of visceral aorta (eg, aneurysm, pseudoaneurysm, dissection, penetrating ulcer, intramural hematoma, or traumatic disruption) by deployment of a fenestrated visceral aortic endograft and all associated radiological supervision and interpretation, including target zone angioplasty, when performed; including four or more visceral artery endoprostheses (superior mesenteric, celiac and/or renal artery[s]) C C C N/ACMS-1612-FC 334

HCPCS

Code Long Descriptor CY 2014 WRVU RUC/HCPAC Recommended

Work RVU CY 2015 Work RVU CMS Time Refinement

34845 Endovascular repair of visceral aorta and infrarenal abdominal aorta (eg, aneurysm, pseudoaneurysm, dissection, penetrating ulcer, intramural hematoma, or traumatic disruption) with a fenestrated visceral aortic endograft and concomitant unibody or modular infrarenal aortic endograft and all associated radiological supervision and interpretation, including target zone angioplasty, when performed; including one visceral artery endoprosthesis (superior mesenteric, celiac or renal artery) C C C N/A

34846 Endovascular repair of visceral aorta and infrarenal abdominal aorta (eg, aneurysm, pseudoaneurysm, dissection, penetrating ulcer, intramural hematoma, or traumatic disruption) with a fenestrated visceral aortic endograft and concomitant unibody or modular infrarenal aortic endograft and all associated radiological supervision and interpretation, including target zone angioplasty, when performed; including two visceral artery endoprostheses (superior mesenteric, celiac and/or renal artery[s]) C C C N/A

34847 Endovascular repair of visceral aorta and infrarenal abdominal aorta (eg, aneurysm, pseudoaneurysm, dissection, penetrating ulcer, intramural hematoma, or traumatic disruption) with a fenestrated visceral aortic endograft and concomitant unibody or modular infrarenal aortic endograft and all associated radiological supervision and interpretation, including target zone angioplasty, when performed; includi ng three visceral artery endoprostheses (superior mesenteric, celiac and/or renal artery[s]) C C C N/A

34848 Endovascular repair of visceral aorta and infrarenal abdominal aorta (eg, aneurysm, pseudoaneurysm, dissection, penetrating ulcer, intramural hematoma, or traumatic disruption) with a fenestrated visceral aortic endograft and concomitant unibody or modular infrarenal aortic endograft and all associated radiological supervision and interpretation, including target zone angioplasty, when performed; including four or more visceral artery endoprostheses (s uperior mesenteric, celiac and/or renal artery[s]) C C C N/A

36475 Endovenous ablation therapy of incompetent vein, extremity, inclusive of all imaging guidance and monitoring, percutaneous, radiofrequency; first vein treated 6.72 5.30 5.30 NoCMS-1612-FC 335

HCPCS

Code Long Descriptor CY 2014 WRVU RUC/HCPAC Recommended

Work RVU CY 2015 Work RVU CMS Time Refinement

36476 Endovenous ablation therapy of incompetent vein, extremity, inclusive of all imaging guidance and monitoring, percutaneous, radiofrequency; second and subsequent veins treated in a single extremity, each through separate access sites (list separately in addition to code for primary procedure) 3.38 2.65 2.65 No

36478 Endovenous ablation therapy of incompetent vein, extremity, inclusive of all imaging guidance and monitoring, percutaneous, laser; first vein treated 6.72 5.30 5.30 No

36479 Endovenous ablation therapy of incompetent vein, extremity, inclusive of all imaging guidance and monitoring, percutaneous, laser; second and subsequent veins treated in a single extremity, each through separate access sites (list separately in addition to code for primary procedure) 3.38 2.65 2.65 No

36818 Arteriovenous anastomosis, open; by upper arm cephalic vein transposition 11.89 13.00 12.39 No

36819 Arteriovenous anastomosis, open; by upper arm basilic vein transposition 13.29 15.00 13.29 No

36820 Arteriovenous anastomosis, open; by forearm vein transposition 14.47 13.99 13.07 No

36821 Arteriovenous anastomosis, open; direct, any site (eg, cimino type) (separate procedure) 12.11 11.90 11.90 No

36825 Creation of arteriovenous fistula by other than direct arteriovenous anastomosi s (separate procedure); autogenous graft 14.17 15.93 14.17 No

36830 Creation of arteriovenous fistula by other than direct arteriovenous anastomosi s (separate procedure); nonautogenous graft (eg, biological collagen, thermoplastic graft) 12.03 11.90 12.03 No

36831 Thrombectomy, open, arteriovenous fistula without revision, autogenous or nonautogenous dialysis graft (separate procedure) 8.04 11.00 11.00 Yes

36832 Revision, open, arteriovenous fistula; without thrombectomy, autogenous or nonautogenous dialysis graft (separate procedure) 10.53 13.50 13.50 Yes

36833 Revision, open, arteriovenous fistula; with thrombectomy, autogenous or nonautogenous dialysis graft (separate procedure) 11.98 14.50 14.50 YesCMS-1612-FC 336

HCPCS

Code Long Descriptor CY 2014 WRVU RUC/HCPAC Recommended

Work RVU CY 2015 Work RVU CMS Time Refinement

37218 Transcatheter placement of intravascular stent(s), intrathoracic common carotid artery or innominate artery, open or percutaneous antegrade approach, including angioplasty, when performed, and radiological supervision and interpretation New 15.00 15.00 No

43180 Esophagoscopy, rigid, transoral with diverticulectomy of hypopharynx or cervical esophagus (eg, zenker's diverticulum), with cricopharyngeal myotomy, includes use of telescope or operating microscope and repair, when performed New 9.03 9.03 No

44381 Ileoscopy, through stoma; with transendoscopic balloon dilation New 1.48 I N/A

44384 Ileoscopy, through stom a; with placement of endoscopic stent (includes pre- and post-dilation and guide wire passage, when performed) New 3.11 I N/A

44401 Colonoscopy through stoma; with ablation oftumor(s), polyp(s), or other lesion(s) (includes preand post-dilation and guid e wire passage, when performed) New 4.44 I N/A

44402 Colonoscopy through stoma; with endoscopic stent placement (including pre- and post-dilation and guide wire passage, when performed) New 4.96 I N/A

44403 Colonoscopy through stoma; with endoscopic mucosal resection New 5.81 I N/A

44404 Colonoscopy through stoma; with directed submucosal injection(s), any substance New 3.13 I N/A

44405 Colonoscopy through stoma; with transendoscopic balloon dilation New 3.33 I N/A

44406 Colonoscopy through stoma; with endoscopic ultrasound examination, limited to the sigmoid, descending, transverse, or ascending colon and cecum and adjacent structures New 4.41 I N/A

44407 Colonoscopy through stoma; with transendoscopic ultrasound guided intramur al or transmural fine needle aspiration/biopsy(s), includes endoscopic ultrasound examination limited to the sigmoid, descending, transverse, or ascending colon and cecum and adjacent structures New 5.06 I N/A

44408 Colonoscopy through stoma; with decompression (for pathologic distention) (eg, volvulus, megacolon), including pl acement of decompression tube, when performed New 4.24 I N/ACMS-1612-FC 337

HCPCS

Code Long Descriptor CY 2014 WRVU RUC/HCPAC Recommended

Work RVU CY 2015 Work RVU CMS Time Refinement

45346 Sigmoidoscopy, flexible; with ablation of tumor(s),polyp(s), or other lesion(s) (includes pre- and postdilation and guide wire passage, when performed) New 2.97 I N/A

45347 Sigmoidoscopy, flexible; with placement of endoscopic stent (includes pre- and post-dilation and guide wire passage, when performed) New 2.98 I N/A

45349 Sigmoidoscopy, flexible; with endoscopic mucosal resection New 3.83 I N/A

45350 Sigmoidoscopy, flexible; with band ligation(s) (eg, hemorrhoids) New 1.78 I N/A

45388 Colonoscopy, flexible; with ablation of tumor(s),polyp(s), or other lesion(s) (includes pre- and postdilation and guide wire passage, when performed) New 4.98 I N/A

45389 Colonoscopy, flexible; with endoscopic stent placement (includes pre- and post-dilation and guide wire passage, when performed) New 5.50 I N/A

45390 Colonoscopy, flexible; with endoscopic mucosal resection New 6.35 I N/A

45393 Colonoscopy, flexible; with decompression (for pathologic distention) (eg, volvulus, megacolon), including placement of decompression tube, when performed New 4.78 I N/A

45398 Colonoscopy, flexible; with band ligation(s) (eg, hemorrhoids) New 4.30 N/A 45399 Unlisted procedure, colon New None I N/A

46601 Anoscopy; diagnostic, with high-resolution magnification (hra) (eg, colposcope, operating microscope) and chemical agent enhancement, including collection of specimen(s) by brushing or washing, when performed New 1.60 I N/A

46607 Anoscopy; with high-resolution magnification (hra) (eg, colposcope, operating microscope) and chemical agent enhancement, with biopsy, single or multiple New 2.20 I N/A

47383 Ablation, 1 or more liver tumor(s), percutaneous, cryoablation New 9.13 9.13 No

52441 Cystourethroscopy, with insertion of permanent adjustable transprostatic implant; single implant New 4.50 4.50 No

52442 Cystourethroscopy, with insertion of permanent adjustable transprostatic implant; each additional permanent adjustable transprostatic implant (list separately in addition to code for primary procedure) New 1.20 1.20 NoCMS-1612-FC 338

HCPCS

Code Long Descriptor CY 2014 WRVU RUC/HCPAC Recommended

Work RVU CY 2015 Work RVU CMS Time Refinement

55840 Prostatectomy, retropubic radical, with or without nerve sparing; 24.63 21.36 21.36 No

55842 Prostatectomy, retropubic radical, with or without nerve sparing; with lymph node biopsy(s) (limited pelvic lymphadenectomy) 26.49 24.16 21.36 No

55845 Prostatectomy, retropubic radical, with or without nerve sparing; with bilateral pelvic lymphadenectomy, including external iliac, hypogastric, and obturator nodes 30.67 29.07 25.18 No

58541 Laparoscopy, surgical, su pracervical hysterectomy, for uterus 250 g or less; 14.70 12.29 12.29 No

58542 Laparoscopy, surgical, su pracervical hysterectomy, for uterus 250 g or less; with removal of tube(s) and/or ovary(s) 16.56 14.16 14.16 No

58543 Laparoscopy, surgical, su pracervical hysterectomy, for uterus greater than 250 g; 16.87 14.39 14.39 No

58544 Laparoscopy, surgical, su pracervical hysterectomy, for uterus greater than 250 g; with removal of tube(s) and/or ovary(s) 18.37 15.60 15.60 No

58570 Laparoscopy, surgical, with total hysterectomy, for uterus 250 g or less; 15.88 13.36 13.36 No

58571 Laparoscopy, surgical, with total hysterectomy, for uterus 250 g or less; with removal of tube(s) and/or ovary(s) 17.69 15.00 15.00 No

58572 Laparoscopy, surgical, with total hysterectomy, for uterus greater than 250 g; 20.09 17.71 17.71 No

58573 Laparoscopy, surgical, with total hysterectomy, for uterus greater than 250 g; with removal of tube(s) and/or ovary(s) 23.11 20.79 20.79 No

62284 Injection procedure for myelography and/or computed tomography, lumbar (other than c1-c2 and posterior fossa) 1.54 1.54 1.54 No

62302 Myelography via lumbar injection, including radiological supervision and interpretation; cervical New 2.29 2.29 No

62303 Myelography via lumbar injection, including radiological supervision and interpretation; thoracic New 2.29 2.29 No

62304 Myelography via lumbar injection, including radiological supervision and interpretation; lumbosacral New 2.25 2.25 NoCMS-1612-FC 339

HCPCS

Code Long Descriptor CY 2014 WRVU RUC/HCPAC Recommended

Work RVU CY 2015 Work RVU CMS Time Refinement

62305 Myelography via lumbar injection, including radiological supervision and interpretation; 2 or more regions (eg, lumbar/thoracic, cervical/thoracic, lumbar/cervical, lumb ar/thoracic/cervical) New 2.35 2.35 No

64486 Transversus abdominis plane (tap) block (abdominal plane block, rectus sheath block) unilateral; by injection(s) (includes imaging guidance, when performed) New 1.27 1.27 No

64487 Transversus abdominis plane (tap) block (abdominal plane block, rectus sheath block) unilateral; by continuous infusion(s) (includes imaging guidance, when performed) New 1.48 1.48 No

64488 Transversus abdominis plane (tap) block (abdominal plane block, rectus sheath block) bilateral; by injections (includes imaging guidance, when performed) New 1.60 1.60 No

64489 Transversus abdominis plane (tap) block (abdominal plane block, rectus sheath block) bilateral; by continuous infusions (includes imaging guidance, when performed) New 1.80 1.80 No

64561 Percutaneous implantation of neurostimulator electrode array; sacral nerve (transforaminal placement) including image guidance, if performed 7.15 5.44 5.44 No

66179 Aqueous shunt to extraocular equatorial plate reservoir, external a pproach; without graft New 14.00 14.00 No

66180 Aqueous shunt to extraocular equatorial plate reservoir, external approach; with graft 16.30 15.00 15.00 No

66184 Revision of aqueous shunt to extraocular equatorial plate reservoir; without graft New 9.58 9.58 No

66185 Revision of aqueous shunt to extraocular equatorial plate reservoir; with graft 9.58 10.58 10.58 No 67036 Vitrectomy, mechanical, pars plana approach; 13.32 12.13 12.13 No

67039 Vitrectomy, mechanical, pa rs plana approach; with focal endolaser photocoagulation 16.74 13.20 13.20 No

67040 Vitrectomy, mechanical, pa rs plana approach; with endolaser panretinal photocoagulation 19.61 14.50 14.50 No

67041 Vitrectomy, mechanical, pa rs plana approach; with removal of preretinal cellular membrane (eg, macular pucker) 19.25 16.33 16.33 NoCMS-1612-FC 340

HCPCS

Code Long Descriptor CY 2014 WRVU RUC/HCPAC Recommended

Work RVU CY 2015 Work RVU CMS Time Refinement

67042 Vitrectomy, mechanical, pa rs plana approach; with removal of internal limiting membrane of retina (eg, for repair of macular hole, diabetic macular edema), includes, if performed, intraocular tamponade (ie, air, gas or silicone oil) 22.38 16.33 16.33 No

67043 Vitrectomy, mechanical, pa rs plana approach; with removal of subretinal membrane (eg, choroidal neovascularization), includes, if performed, intraocular tamponade (ie, air, gas or silicone oil) and laser photocoagulation 23.24 17.40 17.40 No

67255 Scleral reinforcement (separate procedure); with graft 10.17 10.17 8.38 No

70486 Computed tomography, maxi llofacial area; without contrast material 1.14 0.85 0.85 No

70487 Computed tomography, ma xillofacial area; with contrast material(s) 1.30 1.17 1.13 No

70488 Computed tomography, maxi llofacial area; without contrast material, followed by contrast material(s) and further sections 1.42 1.30 1.27 No

70496 Computed tomographic angiography, head, with contrast material(s), including noncontrast images, if performed, and image postprocessing 1.75 1.75 1.75 No

70498 Computed tomographic angiography, neck, with contrast material(s), including noncontrast images, if performed, and image postprocessing 1.75 1.75 1.75 No

71275 Computed tomographic angiography, chest (noncoronary), with contrast material(s), including noncontrast images, if performed, and image postprocessing 1.92 1.82 1.82 No

72191 Computed tomographic angiography, pelvis, with contrast material(s), including noncontrast images, if performed, and image postprocessing 1.81 1.81 1.81 No

72240 Myelography, cervical, radiological supervision and interpretation 0.91 0.91 0.91 No

72255 Myelography, thoracic, radiological supervision and interpretation 0.91 0.91 0.91 No

72265 Myelography, lumbosacral, radiological supervision and interpretation 0.83 0.83 0.83 No

72270 Myelography, 2 or more regions (eg, lumbar/thoracic, cervical/thoracic, lumbar/cervical, lumbar/thoracic/cervical), radiological supervision and interpretation 1.33 1.33 1.33 NoCMS-1612-FC 341

HCPCS

Code Long Descriptor CY 2014 WRVU RUC/HCPAC Recommended

Work RVU CY 2015 Work RVU CMS Time Refinement

74174 Computed tomographic angiography, abdomen and pelvis, with contrast material(s), including noncontrast images, if performed, and image postprocessing 2.20 2.20 2.20 No

74175 Computed tomographic angiography, abdomen, with contrast material(s), including noncontrast images, if performed, and image postprocessing 1.90 1.82 1.82 No

74230 Swallowing function, with cineradiography/videoradiography 0.53 0.53 0.53 No

76641 Ultrasound, breast, unilatera l, real time with image documentation, including axilla when performed; complete New 0.73 0.73 No

76642 Ultrasound, breast, unilatera l, real time with image documentation, including axilla when performed; limited New 0.68 0.68 No

76700 Ultrasound, abdominal, real time with image documentation; complete 0.81 0.81 0.81 No

76705 Ultrasound, abdominal, real time with image documentation; limited (eg, single organ, quadrant, follow-up) 0.59 0.59 0.59 No

76770 Ultrasound, retroperitoneal (e g, renal, aorta, nodes), real time with image documentation; complete 0.74 0.74 0.74 No

76775 Ultrasound, retroperitoneal (e g, renal, aorta, nodes), real time with image documentation; limited 0.58 0.58 0.58 No

76856 Ultrasound, pelvic (nonobs tetric), real time with image documentation; complete 0.69 0.69 0.69 No

76857 Ultrasound, pelvic (nonobs tetric), real time with image documentation; limited or follow-up (eg, for follicles) 0.38 0.50 0.50 No

76930 Ultrasonic guidance for pericardiocentesis, imaging supervision and interpretation 0.67 0.67 0.67 No

76932 Ultrasonic guidance for endomyocardial biopsy, imaging supervision and interpretation C 0.85 0.85 No

76942 Ultrasonic guidance for needle placement (eg, biopsy, aspiration, injection, localization device), imaging supervision and interpretation 0.67 0.67 0.67 No

76948 Ultrasonic guidance for aspiration of ova, imaging supervision and interpretation 0.38 0.92 0.92 No 77061 Digital breast tomosynthesis; unilateral New 0.70 I N/A 77062 Digital breast tomosynthesis; bilateral New 0.90 I N/A

77063 Screening digital breast tomosynthesis, bilateral (list separately in addition to code for primary procedure) New 0.60 0.60 NoCMS-1612-FC 342

HCPCS

Code Long Descriptor CY 2014 WRVU RUC/HCPAC Recommended

Work RVU CY 2015 Work RVU CMS Time Refinement

77080 Dual-energy x-ray absorptiometry (dxa), bone density study, 1 or more sites; axial skeleton (eg, hips, pelvis, spine) 0.20 0.20 0.20 No

77085 Dual-energy x-ray absorptiometry (dxa), bone density study, 1 or more sites; axial skeleton (eg, hips, pelvis, spine), including vertebral fracture assessment New 0.30 0.30 No

77086 Vertebral fracture assessment via dual-energy x-ray absorptiometry (dxa) New 0.17 0.17 No

77300 Basic radiation dosimetry calculation, central axis depth dose calculation, tdf, nsd, gap calculation, off axis factor, tissue inhomogeneity factors, calculation of non-ionizing radiation surface and depth dose, as required during course of treatment, only when prescribed by the treating physician 0.62 0.62 0.62 No

77306 Teletherapy isodose plan; simple (1 or 2 unmodified ports directed to a single area of interest), includes basic dosimetry calculation(s) New 1.40 1.40 No

77307 Teletherapy isodose plan; complex (multiple treatment areas, tangential po rts, the use of wedges, blocking, rotational beam, or special beam considerations), incl udes basic dosimetry calculation(s) New 2.90 2.90 No

77316 Brachytherapy isodose plan ; simple (calculation[s] made from 1 to 4 sources, or remote afterloading brachytherapy, 1 channel), includes basic dosimetry calculation(s) New 1.50 1.40 No

77317 Brachytherapy isodose plan; intermediate (calculation[s] made from 5 to 10 sources, or remote afterloading brachytherapy, 2-12 channels), includes basic dosimetry calculation(s) New 1.83 1.83 No

77318 Brachytherapy isodose plan; complex (calculation[s] made from over 10 sources, or remote afterloading brachytherapy, over 12 channels), includes basic dosimetry calculation(s) New 2.90 2.90 No

77385 Intensity modulated radiation treatment delivery (imrt), includes guidance and tracking, when performed; simple New I N/A

77386 Intensity modulated radiation treatment delivery (imrt), includes guidance and tracking, when performed; complex New I N/A

77387 Guidance for localization of target volume for delivery of radiation treatment delivery, includes intrafraction tracking, when performed New 0.58 I N/ACMS-1612-FC 343

HCPCS

Code Long Descriptor CY 2014 WRVU RUC/HCPAC Recommended

Work RVU CY 2015 Work RVU CMS Time Refinement

77402 Radiation treatment delivery, >1 mev; simple 0.00 I N/A 77407 Radiation treatment delivery, >1 mev; intermediate 0.00 I N/A 77412 Radiation treatment delivery, >1 mev; complex 0.00 I N/A

88341 Immunohistochemistry or immunocytochemistry, per specimen; each additional single antibody stain procedure (list separately in addition to code for primary procedure) New 0.65 0.42 No

88342 Immunohistochemistry or immunocytochemistry, per specimen; initial single antibody stain procedure I 0.70 0.70 No

88344 Immunohistochemistry or immunocytochemistry, per specimen; each multiplex antibody stain procedure New 0.77 0.77 No 88356 Morphometric analysis; nerve 3.02 2.80 2.80 No

88364 In situ hybridization (eg, fish), per specimen; each additional single probe stain procedure (list separately in addition to code for primary procedure) New 0.88 0.53 No

88365 In situ hybridization (eg, fish), per specimen; initial single probe stain procedure 1.20 0.88 0.88 No

88366 In situ hybridization (eg, fish), per specimen; each multiplex probe stain procedure New 1.24 1.24 No

88367 Morphometric analysis, in situ hybridization(quantitative or semi-quantitative), using computerassisted technology, per specimen; initial single probe stain procedure 1.30 0.86 0.73 No

88368 Morphometric analysis, in situ hybridization (quantitative or semi-quantitative), manual, per specimen; initial single probe stain procedure 1.40 0.88 0.88 No

88369 Morphometric analysis, in situ hybridization (quantitative or semi-quantitative), manual, per specimen; each additiona l single probe stain procedure (list separately in addition to code for primary procedure) New 0.88 0.53 No

88373 Morphometric analysis, in situ hybridization(quantitative or semi-quantitative), using computerassisted technology, per specimen; each additional single probe stain procedure (list separately in addition to code for primary procedure) New 0.86 0.43 No

88374 Morphometric analysis, in situ hybridization(quantitative or semi-quantitative), using computerassisted technology, per specimen; each multiplex probe stain procedure New 1.04 0.93 NoCMS-1612-FC 344

HCPCS

Code Long Descriptor CY 2014 WRVU RUC/HCPAC Recommended

Work RVU CY 2015 Work RVU CMS Time Refinement

88377 Morphometric analysis, in situ hybridization (quantitative or semi-quantitative), manual, per specimen; each multiplex probe stain procedure New 1.40 1.40 No

88380 Microdissection (ie, sample preparation of microscopically identified target); laser capture 1.56 1.14 1.14 No

88381 Microdissection (ie, sample preparation of microscopically identified target); manual 1.18 0.53 0.53 No

91200 Liver elastography, mechanically induced shear wave (eg, vibration), without imaging, with interpretation and report New 0.30 0.30 No

92145 Corneal hysteresis determination, by air impulse stimulation, unilateral or bilateral, with interpretation and report New 0.17 0.17 No

92540 Basic vestibular evaluation, includes spontaneous nystagmus test with eccentric gaze fixation nystagmus, with recording, positional nystagmus test, minimum of 4 positions, with recording, optokinetic nystagmus test, bidirectional foveal and peripheral stimulation, with recording, and oscillating tracking test, with recording 1.50 1.50 1.50 No

92541 Spontaneous nystagmus te st, including gaze and fixation nystagmus, with recording 0.40 0.40 0.40 No

92542 Positional nystagmus test, minimum of 4 positions, with recording 0.33 0.48 0.48 No

92543 Caloric vestibular test, each irrigation (binaural, bithermal stimulation constitutes 4 tests), with recording 0.10 0.35 0.10 No

92544 Optokinetic nystagmus test, bidirectional, foveal or peripheral stimulation, with recording 0.26 0.27 0.27 No 92545 Oscillating tracking test, with recording 0.23 0.27 0.27 No

93260 Programming device evaluation (in person) with iterative adjustment of the implantable device to test the function of the device and select optimal permanent programmed values with analysis, review and report by a physician or other qualified health care professional; implantable subcutaneous lead defibrillator system New 0.85 0.85 No

93261 Interrogation device evaluation (in person) with analysis, review and report by a physician or other qualified health care professional, includes connection, recording and disconnection per patient encounter; implantable subcutaneous lead defibrillator system New 0.74 0.74 NoCMS-1612-FC 345

HCPCS

Code Long Descriptor CY 2014 WRVU RUC/HCPAC Recommended

Work RVU CY 2015 Work RVU CMS Time Refinement

93282 Programming device evaluation (in person) with iterative adjustment of the implantable device to test the function of the device and select optimal permanent programmed values with analysis, review and report by a physician or other qualified health care professional; single lead transvenous implantable defibrillator system 0.85 0.85 0.85 No

93283 Programming device evaluation (in person) with iterative adjustment of the implantable device to test the function of the device and select optimal permanent programmed values with analysis, review and report by a physician or other qualified health care professiona l; dual lead transvenous implantable defibrillator system 1.15 1.15 1.15 No

93284 Programming device evaluation (in person) with iterative adjustment of the implantable device to test the function of the device and select optimal permanent programmed values with analysis, review and report by a physician or other qualified health care professional; multiple lead transvenous implantable defibrillator system 1.25 1.25 1.25 No

93287 Peri-procedural device evaluation (in person) and programming of device system parameters before or after a surgery, procedure, or test with analysis, review and report by a physician or other qualified health care professional; single, dual, or multiple lead implantable defibrillator system 0.45 0.45 0.45 No

93289 Interrogation device evaluation (in person) with analysis, review and report by a physician or other qualified health care professional, includes connection, recording and disconnection per patient encounter; single, dual, or multiple lead transvenous implantable defibrillator system, including analysis of heart rhythm derived data elements 0.92 0.92 0.92 No

93312 Echocardiography, transeso phageal, real -time with image documentation (2d) (with or without m-mode recording); including probe placement, image acquisition, interpretation and report 2.20 3.18 2.55 No

93313 Echocardiography, transeso phageal, real -time with image documentation (2d) (with or without m-mode recording); placement of transesophageal probe only 0.95 1.00 0.51 NoCMS-1612-FC 346

HCPCS

Code Long Descriptor CY 2014 WRVU RUC/HCPAC Recommended

Work RVU CY 2015 Work RVU CMS Time Refinement

93314 Echocardiography, transeso phageal, real -time with image documentation (2d) (with or without m-mode recording); image acquisition, interpretation and report only 1.25 2.80 2.10 Yes

93315 Transesophageal echocardiography for congenital cardiac anomalies; including probe placement, image acquisition, interpretation and report C 3.29 2.94 No

93316 Transesophageal echocardiography for congenital cardiac anomalies; placement of transesophageal probe only 0.95 1.50 0.85 No

93317 Transesophageal echocardiography for congenital cardiac anomalies; image acq uisition, interpretation and report only C 3.00 2.09 Yes

93318 Echocardiography, transe sophageal (tee) for monitoring purposes, in cluding probe placement, real time 2-dimensional image acquisition and interpretation leading to ongoing (continuous) assessment of (dynamically changing) cardiac pumping function and to therapeutic measures on an immediate time basis C 2.40 2.40 No

93320 Doppler echocardiography, pulsed wave and/or continuous wave with spectral display (list separately in addition to codes for echocardiographic imaging); complete 0.38 0.38 0.38 No

93321 Doppler echocardiography, pulsed wave and/or continuous wave with spectral display (list separately in addition to codes for echocardiographic imaging); follow-up or limited study (list separately in addition to codes for echocardiographic imaging) 0.15 0.15 0.15 No

93325 Doppler echocardiography color flow velocity mapping (list separately in addition to codes for echocardiography) 0.07 0.07 0.07 NoCMS-1612-FC 347

HCPCS

Code Long Descriptor CY 2014 WRVU RUC/HCPAC Recommended

Work RVU CY 2015 Work RVU CMS Time Refinement

93355 Echocardiography, transe sophageal (tee) for guidance of a transcatheter intracardiac or great vessel(s) structural intervention(s) (eg,tavr, transcathether pulmonary valve replacement, mitral valve repair, paravalvular regurgitation repair, left atrial appendage occlusio n/closure, ventricular septal defect closure) (p eri-and intra-procedural), real-time image acquisiti on and documentation, guidance with quantitative measurements, probe manipulation, interpretation, and report, including diagnostic transesophageal echocardiography and, when performed, administration of ultrasound contrast, doppler, color flow, and 3d New 4.66 4.66 No

93644 Electrophysiologic evaluation of subcutaneous implantable defibrillator (includes defibrillation threshold evaluation, induction of arrhythmia, evaluation of sensing for arrhythmia termination, and programming or reprogramming of sensing or therapeutic parameters) New 3.65 3.29 No

93880 Duplex scan of extracranial arteries; complete bilateral study 0.60 0.80 0.80 No

93882 Duplex scan of extracranial arteries; unilateral or limited study 0.40 0.50 0.50 No

93886 Transcranial doppler study of the intracranial arteries; complete study 0.94 1.00 0.91 No

93888 Transcranial doppler study of the intracranial arteries; limited study 0.62 0.70 0.50 No

93895 Quantitative carotid intima media thickness and carotid atheroma evaluation, bilateral New 0.55 N No

93925 Duplex scan of lower extremity arteries or arterial bypass grafts; complete bilateral study 0.80 0.80 0.80 No

93926 Duplex scan of lower extremity arteries or arterial bypass grafts; unilateral or limited study 0.50 0.60 0.50 No

93930 Duplex scan of upper extrem ity arteries or arterial bypass grafts; complete bilateral study 0.46 0.80 0.80 No

93931 Duplex scan of upper extrem ity arteries or arterial bypass grafts; unilateral or limited study 0.31 0.50 0.50 No

93970 Duplex scan of extremity veins including responses to compression and other maneuvers; complete bilateral study 0.70 0.70 0.70 No

93971 Duplex scan of extremity veins including responses to compression and other maneuvers; unilateral or limited study 0.45 0.45 0.45 NoCMS-1612-FC 348

HCPCS

Code Long Descriptor CY 2014 WRVU RUC/HCPAC Recommended

Work RVU CY 2015 Work RVU CMS Time Refinement

93975 Duplex scan of arterial inflow and venous outflow of abdominal, pelvic, scrotal contents and/or retroperitoneal organs; complete study 1.80 1.30 1.16 No

93976 Duplex scan of arterial inflow and venous outflow of abdominal, pelvic, scrotal contents and/or retroperitoneal organs; limited study 1.21 1.00 0.80 No

93978 Duplex scan of aorta, inferior vena cava, iliac vasculature, or bypass grafts; complete study 0.65 0.97 0.80 No

93979 Duplex scan of aorta, inferior vena cava, iliac vasculature, or bypass grafts; unilateral or limited study 0.44 0.70 0.50 No

93990 Duplex scan of hemodi alysis access (including arterial inflow, body of access and venous outflow) 0.25 0.60 0.50 No

95971 Electronic analysis of implanted neurostimulator pulse generator system (eg, rate, pulse amplitude, pulse duration, configuration of wave form, battery status, electrode selectability, output modulation, cycling, impedance and patient compliance measurements); simple spin al cord, or peripheral (ie, peripheral nerve, sacr al nerve, neuromuscular) neurostimulator pulse generator/transmitter, with intraoperative or subsequent programming 0.78 0.78 0.78 No

95972 Electronic analysis of implanted neurostimulator pulse generator system (eg, rate, pulse amplitude, pulse duration, configuration of wave form, battery status, electrode selectability, output modulation, cycling, impedance and patient compliance measurements); complex spinal cord, or peripheral (ie, peripheral nerve, sacr al nerve, neuromuscular) (except cranial nerve) neurostimulator pulse generator/transmitter, with intraoperative or subsequent programming, up to 1 hour 1.50 0.90 0.80 No

95973 Electronic analysis of implanted neurostimulator pulse generator system (eg, rate, pulse amplitude, pulse duration, configuration of wave form, battery status, electrode selectability, output modulation, cycling, impedance and patient compliance measurements); complex spinal cord, or peripheral (ie, peripheral nerve, sacr al nerve, neuromuscular) (except cranial nerve) neurostimulator pulse generator/transmitter, with intraoperative or subsequent programming, each additional 30 minutes after first hour (list separately in addition to code for primary procedure) 0.92 NA 0.49 NoCMS-1612-FC 349

HCPCS

Code Long Descriptor CY 2014 WRVU RUC/HCPAC Recommended

Work RVU CY 2015 Work RVU CMS Time Refinement

97605 Negative pressure wound therapy (eg, vacuum assisted drainage collection), utilizing durable medical equipment (dme), including topical application(s), wound assessment, and instruction(s) for ongoing care, per session; total wound(s) surface area less than or equal to 50 square centimeters 0.55 0.55 0.55 No

97606 Negative pressure wound therapy (eg, vacuum assisted drainage collection), utilizing durable medical equipment (dme), including topical application(s), wound assessment, and instruction(s) for ongoing care, per session; total wound(s) surface area greater than 50 square centimeters 0.60 0.60 0.60 No

97607 Negative pressure wound therapy, (eg, vacuum assisted drainage collection), utilizing disposable, non-durable medical equipment including provision of exudate management collection system, topical application(s), wound assessment, and instructions for ongoing care, per session; total wound(s) surface area less than or equal to 50 square centimeters New 0.41 C

97608 Negative pressure wound therapy, (eg, vacuum assisted drainage collection), utilizing disposable, non-durable medical equipment including provision of exudate management collection system, topical application(s), wound assessment, and instructions for ongoing care, per session; total wound(s) surface area greater than 50 square centimeters New 0.46 C Yes

97610 Low frequency, non-contact, non-thermal ultrasound, including topical application(s), when performed, wound assessment, and instruction(s) for ongoing care, per day C 0.35 0.35 No

99183 Physician or other qualified health care professional attendance and supervision of hyperbaric oxygen therapy, per session 2.34 2.11 2.11 No

99184 Initiation of selective head or total body hypothermia in the critically ill neonate, includes appropriate patient selecti on by review of clinical, imaging and laboratory data, confirmation of esophageal temperature probe location, evaluation of amplitude eeg, supervision of controlled hypothermia, and assessment of patient tolerance of cooling New 4.50 4.50 No

99188 Application of topical fluoride varnish by a physician or other qualified health care professional New 0.20 N N/ACMS-1612-FC 350

HCPCS

Code Long Descriptor CY 2014 WRVU RUC/HCPAC Recommended

Work RVU CY 2015 Work RVU CMS Time Refinement

99487 Complex chronic care management services, with the following required elements: multiple (two or more) chronic conditions expected to last at least 12 months, or until the death of the patient; chronic conditions place the patient at significant risk of death, acute exacerbatio n/decompensation, or functional decline; establishment or substantial revision of a comprehensive care plan; moderate or high complexity medical decision making; 60 minutes of clinical staff tim e directed by a physician or other qualified health care professional, per calendar month.; 1.00 1.00 B N/A

99497 Advance care planning in cluding the explanation and discussion of advance directives such as standard forms (with completion of such forms, when performed), by the physician or other qualified health care professional; first 30 minutes, face-to-face with the patient, family member(s), and/or surrogate New 1.50 I N/A

99498 Advance care planning in cluding the explanation and discussion of advance directives such as standard forms (with completion of such forms, when performed), by the physician or other qualified health care professional; each additional 30 minutes (list separately in addition to code for primary procedure) New 1.40 I N/A

G0279 Diagnostic digital breast tomosynthesis, unilateral or bilateral (list separately in addition to G0204 or G0206) New N/A 0.60 N/A

i. Code Specific Issues (1) Internal Fixation of Rib Fract ure (CPT Codes 21811, 21812 and 21813) For CY 2015, the CPT Editorial Panel delete d CPT code 21810 (Treatment of rib fracture requiring external fixation (flail chest)) and replaced it with three CPT codes 21811, 21812 and 21813, to report internal fixation of rib fractur e. The RUC recommended valuing these three codes as 90-day global services. For the reasons we articulate in section II. B.4 of this final rule with comment period about the difficulties in accu rately valuing codes as 90-day global services,

we believe that the valuation of these codes shoul d be as 0-day global services. In addition, weCMS-1612-FC 351 believe this is particularly appropriate for these codes because the number of RUC-recommended inpatient and outpatient visits included in th e postservice time seems higher than would likely occur. The vignette for CPT code 21811 describes an elderly patient who falls and experiences three rib fractures that require in ternal fixation. The seven visits included in the postservice time for this code seem high since the vignette does no t describe a very ill patient. The vignettes for CPT codes 21812 and 21813 describe patients expe riencing significant ri b fractures in car accidents that require internal fixation. We belie ve that in these scenarios, injuries beyond rib fractures are likely, and as a result, we believe it is likely that multiple practitioners would be involved in providing post- operative care. If othe r practitioners would furnish care in the postsurgery period, we believe the te n and thirteen postservice vi sits included in CPT codes 21812 and 21813 would likely not occur. By valuing thes e codes as 0-day globals, we do not need to address these issues because the surgeon will be able to bill separately for the postoperative

services that are furnished afte r the day of the procedure. To value these services as 0-day global code s, we subtracted the work RVUs related to the postoperative services from the total work RVU. We are establishing CY 2015 interim work RVUs of 10.79 for CPT code 21811, of 13.00 fo r CPT code 21812, and of 17.61 for CPT code

21813. We also refined the RUC recommended time by subtracting the time associated with the postoperative visits. By removing the work and time associated with visits in the postoperative period, the remaining work and time reflect the work and time of services furnished on the day of

surgery. (2) Percutaneous Vertebroplasty an d Augmentation (CPT Codes 22510, 22511, 22512, 22513, 22514 and 22515) For CY 2015, the CPT Editorial Panel re placed the eight existing percutaneous vertebroplasty with six new codes, CPT codes 22510-22515, which include the percutaneousCMS-1612-FC 352 vertebroplasty and the image guidance togeth er. We are establishing the RUC-recommended work values as interim final for CY 2015 for all of the codes in this family except CPT code

22511. Unlike other codes in this family for which the RUC-recommended work RVU was based on the 25th percentile in th e survey, the RUC established its recommended work value for CPT code 22511 by crosswalking th is service to CPT code 39400 (Mediastinoscopy, includes biopsy(ies), when performed), which has a work RVU of 8.05. Because the level of work performed by a physician in the two services differs, we do not agree that this crosswalk is appropriate. Instead, we believe a more appropriate analogy is found in the difference between the work values for the predecessor codes for CPT codes 22510 and 22511, CPT codes 22520 (Percutaneous vertebroplasty (bone biopsy in cluded when performed), 1 vertebral body,

unilateral or bilate ral injection; thor acic) and 22521 (Percutaneous vertebroplasty (bone biopsy included when performed), 1 vertebral body, unilateral or bilateral in jection; thoracic; lumbar). Accordingly, we are applying the difference in the current work RVUs for CPT codes 22520 and 22521 to the work RVU that we are establishing for CPT code 22510. We believe this increment establishes the appropriate rank order in this fam ily and thus are assigning an interim final work RVU of 7.58 for CPT code 22511, which is 0.57 work RVUs lower than the CY 2015 work

RVU for CPT code 22510. (3) Endobronchial Ultrasound (EBUS) (CPT Code 31620) For CY 2015, the RUC reviewed CPT code 31620 because it was identified through the High Volume Growth Services, which are thos e services for which Medicare utilization increased by at least 100 per cent from 2006 to 2011. CPT code 31620 is an add-on code to CPT code 31629 (Bronchoscopy, rigid or flexible, incl uding fluoroscopic guidance, when performed; with transbronchial needle aspi ration biopsy(s), trachea, main st em and/or lobar bronchus(i)).CMS-1612-FC 353 Medicare data show that 82 percen t of the time when EBUS is billed it is billed with CPT code 31629. Given this relationship, we believe th at CPT code 31620 should be bundled with CPT code 31629. The specialty societies maintain that EBUS is distinct from bronchoscopy with biopsy because the intraservice work of EBUS occurs between the two components of the base code, bronchoscopy and biopsy. However, base d upon the discussion at the RUC meeting, we believe that the biopsy actually occurs during the EBUS and the biopsy is actually performed through the EBUS scope. Thus, we do not beli eve the EBUS code descriptor accurately describes the service nor is it possible to accurate ly value this service when the descriptor is inaccurate. Therefore, for CY 2015 we are main taining the CY 2014 work RVU for CPT code

31620. We understand that the RUC will review this code for CY 2016. (4) Extracorporeal Membrane Oxygenation (ECMO) /Extracorporeal Life Support (ECLS) (CPT Codes 33946, 33947, 33948, 33949, 33951- 33959, 33962-33966, 33969, 33984 -33989) In the CY 2014 PFS final rule with comment period, CPT codes 33960 (Prolonged extracorporeal circulation for cardiopulmonary insufficiency; initial day) and 33961 (Prolonged extracorporeal circulation for cardiopulmonary insufficiency; each subsequent day) were identified as potentially misvalued codes. Specifi cally, the services were originally valued when they were primarily provided to premature neonate s; but the services are now typically used in treating adults with severe influenza, pneumoni a, and respiratory distress syndrome. For CY 2015, CPT codes 33960 and 33961 were deleted and repl aced with 25 new codes to describe this treatment. We are assigning the RUC-recomme nded work values as interim final for CY 2015 for all of the codes in this family except CPT codes 33952, 33953, 33954, 33957, 33958 and 33959, 33962, 33969, and 33984. We accepted the RUC-recommended work RVU of 8.15 for CPT code 33951, which describes an ECMO peripheral cannula(e) inserti on for individuals up to 5 years of age. TheCMS-1612-FC 354

RUC recommended a work RVU of 8.43 for CPT code 33952, which describes the same procedure for individuals 6 years and older. We do not believe this difference in the age of the patient increases the work of the service fr om the younger patient. The fact that the RUCrecommended intraservice time is identical for bo th codes supports our vi ew that the work RVU should be the same for both codes. Therefore, for CY 2015, we are establishing an interim final work RVUs of 8.15 for CPT code 33952, the same as we established for CPT 33951 based upon the RUC-recommendation for the younger patient. The RUC recommended work RVUs of 9.83 and 9.43 for CPT codes 33953 and 33954, respectively. For the same reas ons discussed above, we are esta blishing the same work values for the code for treatment of patients from birth through 5 years of age and the code for treatment of patients 6 years and older. To determine the value for these codes, we adjusted the work RVU of the equivalent percutaneous codes, CP T code 33951 (Extracorporeal membrane oxygenation (ECMO)/extracorporeal life support (ECLS) pr ovided by physician; insertion of peripheral (arterial and/or venous) cannula( e), percutaneous, birth thro ugh 5 years of age (includes fluoroscopic guidance, when performed)) a nd CPT code 33952 (Extracorporeal membrane oxygenation (ECMO)/extracorporeal life support (E CLS) provided by physician; insertion of peripheral (arterial and/or ve nous) cannula(e), percutaneous, 6 years and older (includes fluoroscopic guidance, when performed)), to re flect the greater work of the open procedure codes, CPT codes 33953 (Extracorporeal memb rane oxygenation (ECMO)/extracorporeal life support (ECLS) provided by physician; insertio n of peripheral (arterial and/or venous) cannula(e), open birth, through 5 years of age) and 33954 (Extracorporeal membrane oxygenation (ECMO)/extracorporeal life support (E CLS) provided by physician; insertion of peripheral (arterial and/or ve nous) cannula(e), open, 6 years a nd older). To measure the

difference in work between these two sets of codes we applied the 0.96 RVU differentialCMS-1612-FC 355 between the percutaneous arterial CPT code 33620 (Application of right and left pulmonary artery bands (for example, hybrid approach stage 1)) and the open arterial CPT code 36625 (Arterial catheterizati on or cannulation for sampling, mon itoring or transfusion (separate procedure); cutdown) codes. This measure allows us to establis h the difference in work between the sets of codes based upon the difference in in tensity. Accordingly, we are assigning an interim

final work RVU to CPT codes 33953 and 33954 of 9.11. Unlike other codes in this family for which the RUC-recommended work value was based upon the 25th percentile of the su rvey, for CPT codes 33957 and 33958 the RUC recommended a work RVU of 4.00 and 4.05, respectively, based upon the survey median. We believe that, like other services in this famil y, these codes should be valued based upon the 25th percentile values of the survey because those va lues best describe the work involved in these procedures and results in the a ppropriate relativity amongst the codes in the family. Therefore, for CY 2015 we are assigning an interim fi nal work RVU of 3.51 for CPT codes 33957 and

33958.

We believe the RUC-recommended work RVUs of 4.69 and 4.73 for CPT codes 33959 and 33962 respectively, overstate the work involved in the services. As we discussed above for CPT codes 33953 and 33954, we believe the differentia l between the percutaneous arterial and open arterial CPT codes more appropriately re flects the work involved in these services. Accordingly we are establishing a CY 2015 inte rim final work RVU of 4.47 for CPT codes

33959 and 33962. After researching comparable codes, we be lieve the RUC-recommended work RVUs of 6.00 and 6.38 for CPT codes 33969 and 33984, respectivel y, overstates the work involved in the procedures. For the same reasons and followi ng the same valuation methodology utilized above,

we added the differential between the percutaneous arterial a nd arterial cutdown codes, 0.96CMS-1612-FC 356 RVU, to the CY 2015 interim final work RVU of 4.50 for CPT code 33966, which is the percutaneous counterpart of CPT code 33984. This results in a work RVU of 5.46 for CPT code

33984. Because CPT code 33969 has 2 minutes less intraservice time than CPT code 33984 (Extracorporeal membrane oxygenation (ECMO)/ext racorporeal life supp ort (ECLS) provided by physician; removal of peripheral (arterial and/ or venous) cannula(e), ope n, 6 years and older), we adjusted the work RVU of CPT code 33984 for the decrease in time to get a work RVU of 5.22 for CPT code 33969 (Extracorporeal membra ne oxygenation (ECMO)/extracorporeal life support (ECLS) provided by physician; remova l of peripheral (art erial and/or venous) cannula(e), open, birth through 5 year s of age). Therefore, for CY 2015 we are establishing an

interim final work RVU of 5.46 to CPT code 33984 and 5.22 to CPT code 33969. (5) Fenestrated Endovascular Repair (F EVAR) Endograft Planni ng (CPT Code 34839) For CY 2015, CPT code 34839 was created to repor t the planning that oc curs prior to the work included in the global period for a FEVAR . The RUC recommended that we contractor price this service as the RUC survey response rate was too low to provide the basis for an appropriate valuation. In general, we pref er that planning be bundl ed with the underlying service, and we have no reason to believe bundling is not appropriate in this case. Accordingly, we are assigning a PFS procedure status indi cator of B (Bundled C ode) to CPT code 34839. (6) AV Anastomosis (CPT Codes 36818, 36819, 36820, 36821, 36825, 36830, 36831, 36832, and 36833)

In the CY 2013 PFS final rule with comment period, the AV anastomosis family of services were determined to be potentially mi svalued due to rank orde r anomalies, including

CPT codes 36818-36821 and CPT codes 36825-36830. The RUC recommendations that we received in response also included CPT codes 36831-36833. We are assigning the RUCrecommended work RVUs as CY 2015 interim final values for CPT codes 36821, 36831, 36832CMS-1612-FC 357 and 36833. For CPT code 36831, 36832, and 36833, we are refining to remove the additional 10 minutes of preservice evaluation time. The RUC added 10 minutes of additional pre-service time to these codes for determining the best source of access,. These three codes are revision/repair codes and as such do not need the additional time to determine the access source. For CPT code 36818, the RUC recommended an appr oximately 12 percent increase in work RVU but a total time increase of approximately 4.2 percent. We are assigning a CY 2015 interim final work RVU of 12.39, wh ich reflects a 4.2 percent incr ease from the current value based upon the increase in total time. For CPT code 36819, the RUC-recommended in traservice and total times are only minimally different than the current times. Even though the intraservice and total times decreased minimally, the RUC increased the work R VU. We believe that the small decrease in total time, 2 percent, suggest that the current work RUV is appropriate. Therefore, we are assigning a CY 2015 interim final work RVU of 13.29, which is the current work value.

The RUC recommended a work value of 13.99 for CPT code 36820. The RUC recommended that the postserv ice time of CPT code 36820 be reduced by removing visits. Specifically, a CPT code 99231 and one-half of a CPT code 99238 were removed from the service, which would equal 1.40 RVU. We do not believe that this redu ction was accounted for

in the RUC-recommended work RVU. To acc ount for this reduction in visits, we are establishing a CY 2015 interim final work RVU of 13.07 for CPT 36820 which reflects a 1.40

work RVU reduction in the current work RVU. For CPT code 36825, the RUC-recommended in traservice and total times are only minimally different than the current times. Ho wever, the RUC increased the work RVU. We do

not believe the work RVU should be increased without corresponding time changes. Therefore, we believe the appropriate CY 2015 interim final work RVU is the current work value of 14.17.CMS-1612-FC 358 For CPT code 36830, the RUC-recommended intras ervice and total times are only minimally different than the current times. However, the RUC decreased the work RVU. We do not

believe the work RVU should be decreased with out corresponding time changes. Therefore, we are establishing a CY 2015 interim final work RVU of 12.03, which is equal to the current work

RVU. Furthermore, we refined the total time va lues as follows: 238 minutes for CPT code 36831, 266 minutes for CPT code 36832, and 296 minutes for CPT code 36833. (7) Illeoscopy, Pouchoscopy, Colonoscopy thro ugh Stoma, Flexible Sigmoidoscopy and Colonoscopy (CPT Codes 44380, 44381, 44382, 44383, 44384, 44385, 44386, 44388, 44389, 44390, 44391, 44392, 44393, 44394, 44397, 44401, 44402, 44403, 44404, 44405, 44406, 44407, 44408, 44799, 45330, 45331, 45332, 45333, 45334, 45335, 45337, 45338, 45346, 45340, 45341, 45342, 45345, 45347, 45349, 45350, 45378, 45379, 45380, 45381, 45382, 45383, 45388, 45384, 45385, 45386, 45387, 45389, 45390, 45391, 45392, 45393, 45398, 45399, 0226T, 46601, 0227T, and 46607 and HCPCS Codes G6018, G 6019, G6020, G6021, G6022, G6023, G6024, G6025, G6027, G6028) CPT revised the lower gastrointestinal endoscopy code set for CY 2015 following

identification of some of the c odes as potentially misvalued and the affected specialty society’s

contention that this code set did not allow fo r accurate reporting of se rvices based upon the current practice. The RUC subsequently provid ed recommendations to CMS for valuing these services. In comments on the proposed rule, stak eholders noted our propo sal to begin including proposed values for new, revised and potential ly misvalued codes in the proposed rule. Commenters suggested that, rather than impl ementing this new process in CY 2016, we should implement it immediately and thus defer the va luation of the new GI code set until CY 2016. They indicated that the opportunity to comment prior to implementation of the new values wasCMS-1612-FC 359 important for these codes, many of which have high utilization. In additi on, in this final rule with comment period we discuss the need to mo dify how moderate seda tion is reported and

valued. Since the valuation of most codes in this code set includes moderate sedation, stakeholders suggested that we revalue these codes in conjunc tion with any changes in reporting

and valuation of moderate sedation. We agree with the commenters. In light of th e substantial nature of this code revision and its relationship to the polic ies on moderate sedation, we ar e delaying revaluation of these

codes until CY 2016 when we will be able to in clude proposals in the proposed rule for their valuation, along with considerati on of policies for moderate sedation. Accordingly for CY 2015, we are maintaining the inputs for the lower ga strointestinal endosc opy codes at the CY 2014 levels. (Note: Due to budget neutrality adjustme nts and other system-wide changes, the payment rates may change.) Since the code set is cha nging for CY 2015, includin g the deletion of some of the CY 2014 codes, we are creating G-codes as necessary to allow practitioners to report services to CMS in the same way in CY 2015 that they did in CY 2014 and to maintain payment under the PFS based on the same inputs. All payment policies applicable to the CY 2014 CPT codes will apply to the replacement G-codes. The new and revised CY 2015 CPT codes for lower gastrointestinal endoscopy that will not be recognized by Medicare for CY 2015 are denoted with an “I” (Not valid for Medicare purposes) in Table 26. The chart below lists the Gcodes that we are creating and the CY 2014 CPT codes that they are replacing.CMS-1612-FC 360

TABLE 26: Lower Gastrointestinal Endo scopy G-Codes Replacing CY 2015 CPT Codes

CY 2014 CPT Code 1 CY 2015 HCPCS

Code Long Descriptor

44383 G6018 Ileoscopy,through stoma;with transendoscopic stent placement (includes predilation )

44393 G6019 Colonoscopy through stoma;with ablation of tumor(s),polp(s),or other lesion(s)not amenable to removal by hot biopsy forceps, bipolar cautery or snare technique 44397 G6020 Colonoscopy through stoma;with transendoscopic stent placement (includes predilation) 44799 G6021 Unlisted procedure,intestine

45339 G6022 Sigmoidoscopy, flexible; with ablation of tumor(s),polyp(s),or other lesions(s)not amenable to removal by hot biopsy forceps, bipolar cautery or snare technique 45345 G6023 Sigmoidoscopy, flexib le; with transenoscopic stent placement (includes predilation)

45383 G6024 Colonoscopy, flexible, proximal to splenic flex ure; with ablation of tumor(s), polyp(s), or other lesion(s) not amenable to removal by hot biopsy forceps, bipolar cautery or snare technique

45387 G6025 Colonoscopy, flexible, proximal to splenic flexure; with transendoscopic stent placement (includes predilation)

0226T G6027 Anoscopy, high resolution (HRA) (with magni fication and chemical agent enhancement); diagnostic, including collection of specimen(s) by brushing or washing when performed

0227T G6028 Anoscopy, high resolution (HRA) (with magni fication and chemical agent enhancement); with biopsy(ies)

(8) Prostatectomy (CPT Codes 55842 and 55845)

In the CY 2014 PFS final rule with comment period, we finalized CPT codes 55842 and 55845 as potentially misvalued codes. For CY 2015, the RUC provided recommendations for these services of 29.07 and 24.16, respectively. We disagreed with the RUC-recommended

crosswalk for CPT code 55842. To value CPT c ode 55842, we are crosswalking it to CPT code 55840 (Prostatectomy, retropubic radical, with or w ithout nerve sparing) due to their identical times. Therefore, we are establishing an interim final work RVU of 21.36. For CPT code 55845, we are establishing a work RVU of 25.18 based upon the 25th percentile of the survey. This work RVU results in an 18 percent decrease from the current work RVU, which we believe reflects the changes si nce the last valuati on, based upon a 20 percent

decrease in intraservice time and the 29 percent decrease in total time.

1 This chart only contains CY 2014 codes for which a HCPCS code is being used for CY 2015. Addendum B contains a complete list of CPT and HCPCS codes being recognized by Medicare under the PFS for CY 20115.CMS-1612-FC 361 (9) Aqueous Shunt (CPT Code 66179, 66180, 66184, 66185, and 67255) After identifying CPT code 66180 through the Harvard-Valued Annual Allowed Charges Greater than $10 million screen, the RUC reco mmended work RVUs for the aqueous shunt family for CY 2015. We are establishing the RU C-recommended work RVUs as interim final for all codes in this family except CPT code 67255. The RUC recommended maintaining the

CY 2014 work RVU of 10.17 for CPT 67255. Howeve r, we believe maintaining this value

would be inconsistent with the RUC-recommended d ecreases in total time for the service. As a result, we reduced the work RVU by the same percentage that the RUC recommended a reduction in total time, which results in a CY 2015 interim final work RVU of 8.38 for CPT code

67255. (10) Computed Tomography (CT) – Maxillofacial (CPT Codes 70486, 70487 and 70488) The RUC’s Relativity Assessment Workgroup identified CPT code 70486 for review through the CMS/Other Source – Utilization over 250,000 screen. The involved specialty societies expanded the survey to include CPT codes 70487 and 70488, all of which involve maxillofacial CTs. We are establishing the RUC-recommended work RVU of 0.85 as the CY 2015 interim final value for CPT code 70486, which is without contrast material. The RUC established this recommendation by cr osswalking this code to the e quivalent code in the CT for the head or brain, CPT code 70450 (Computed tomogr aphy, head or brain without contrast). We agree with that method and in order to maintain rank order within and across CT families, we crosswalked CPT code 70487, which is with contra st material(s), to the CPT code 70460, which is the equivalent code in the head or brain family and CPT c ode 70488, which is without contrast materials followed by contrast material(s) and further sections to CPT code 70470, which is the equivalent code in the head or brain family. Therefore, for CY 2015 we are establishing interim

final work RVUs of 1.13 for CPT code 70487 and 1.27 for CPT code 70488.CMS-1612-FC 362 (11) Breast Ultrasound (C PT Codes 76641 and 76642) For CY 2015, the CPT Editorial Panel re placed CPT code 76645 (Ultrasound, breast(s) (unilateral or bilateral), real time with im age documentation) with two codes, CPT codes 76641 (Ultrasound, breast, unilateral, real time with image documen tation, including axilla when performed; complete) and 76642 (Ultrasound, breas t, unilateral, real time with image documentation, including axilla when performe d; limited). The difference between the new codes is that one is for complete breast ultrasound procedures and the other is for limited. We are assigning the RUC-recommended work RVUs of 0.73 and 0.68 to CPT codes 76641 and 76642, respectively, as interim final. One differe nce between the predecessor code and the new ones is that while the predecessor code was used to report unilateral or bilateral breast ultrasounds, the new codes are unila teral ones. To appropriately adjust payment when bilateral procedures are furnished under the PFS, payments are adjusted to 150 pe rcent of th e unilateral payment when a service has a bila teral payment indicator assigned. We are assigning a bilateral payment indicator to these codes. (12) Radiation Therapy Codes (CPT Codes 76950, 77014, 77421, 77387, 77401, 77402, 77403, 77404, 77406, 77407, 77408, 77409, 77411, 77412, 77413, 77414, 77416, 77418, 77385, 77386, 0073T, and 0197T and HCPCS Codes G6001, G6002, G6003, G6004, G6005, G6006, G6007, G6008, G6009, G6010, G6011, G6012, G6013, G6014, G6015, G6016 and G6017) CPT revised the radiation therapy code set for CY 2015 following identification of some of the codes as potentia lly misvalued and the affected spec ialty society’s contention that the provision of radiation therapy c ould not be accurately reported under the existing code set. The RUC subsequently provided recommendations to CMS for valuing these services. Some stakeholders approached CMS with concerns about these codes being revalued as interim final in the final rule with comment period, noting that these codes account for the vast majority ofCMS-1612-FC 363 Medicare payment for radiation therapy centers. They noted our proposal to begin including proposals to value new, revised and potentially misvalued code s in the proposed rule, and suggested that these code valu ations should be delayed to CY 2016 so that they could be addressed under this new process. This would provide affected stakeholders the opportunity to comment prior to the valuations being effectiv e. They also noted that since they do not participate in the RUC, they did not have the opportunity to provide input to the recommendations nor will they have information about the RUC recommendations until CMS

makes this information available in the final rule with comment period. In response to comments and in light of the s ubstantial nature of th is code revision, we are delaying revaluati on of these codes until CY 2016. The coding changes for CY 2015 involve significant changes in how radiation therapy services and associated image guidance are reported. There is substantial wo rk to be done to assure the new valuations for these codes accurately reflect the coding changes. Accord ingly we are delaying the use of the revised radiation therapy code set until CY 2016 when we will be able to include proposals in the proposed rule for their valuation. We are mainta ining the inputs for radiation therapy codes at the CY 2014 levels. (Note: Due to budget ne utrality adjustments and other system-wide changes, the payment rates may change.) Since the code set has changed and some of the CY 2014 codes are being deleted, we ar e creating G-codes as necessary to allow practitioners to continue to report services to CMS in CY 2015 as they did in CY 2014 and for payments to be made in the same way. All payment policies ap plicable to the CY 2014 CPT codes will apply to the replacement G-codes. The new and revise d CY 2015 CPT codes that will not be recognized by Medicare for CY 2015 are deno ted with an “I” (Not valid for Medicare purposes) on Table

27. The chart below lists the G-codes that we are creating and the CY 2014 CPT codes that they are replacing.CMS-1612-FC 364 Additionally, we would like to no te that changes to the prefat ory text modify the services that are appropriately billed with CPT code 77401, which is used to report superficial radiation therapy. This change effectively means that CPT code 77401 is now bundled with many other procedures supporting superficia l radiation therapy. However, the RUC did not review superficial radiation therapy procedures, and ther efore, did not assess whether changes in its valuation were appropriate in light of this bundling. Stakeholders have suggested to us that the change to the prefatory text proh ibits them from billing for codes that were previously frequently

billed in addition to this code and as a result there will be a signifi cant reduction in their payments.” We are interested in informati on on whether the new code set combined with modifications in prefatory text allows for appropr iate reporting of the services associated with superficial radiation and whether the payment con tinues to reflect the re lative resources required to furnish superficial radiation therapy services.CMS-1612-FC 365 TABLE 27: Radiation Therapy G-Codes Replacing CY 2015 CPT Codes

CY 2014 CPT Code 2 CY 2015 HCPCS

Code Long Descriptor 76950 G6001 Ultrasonic guidance for placement of radiation therapy fields

77421 G6002 Stereoscopic X-ray guidance for localization of target volume for the delivery of radiation therapy

77402 G6003 Radiation treatment delivery, single treatment area, single port or parallel opposed ports, simple blocks or no blocks: up to 5MeV

77403 G6004 Radiation treatment delivery, single treatment area, single port or parallel opposed ports, simple blocks or no blocks: 6-10MeV

77404 G6005 Radiation treatment delivery, single treatment area, single port or parallel opposed ports, simple blocks or no blocks: 11-19MeV

77406 G6006 Radiation treatment delivery, single treatment area, single port or parallel opposed ports, simple blocks or no blocks: 20 MeV or greater

77407 G6007 Radiation treatment delivery, 2 separate treatment areas, 3 or more ports on a single treatment area, use of multiple blocks; up to 5MeV

77408 G6008 Radiation treatment delivery, 2 separate treatment areas, 3 or more ports on a single treatment area, use of multiple blocks; 6-10MeV

77409 G6009 Radiation treatment delivery, 2 separate treatment areas, 3 or more ports on a single treatment area, use of multiple blocks; 11-19MeV

77411 G6010 Radiation treatment delivery, 2 separate treatment areas, 3 or more ports on a single treatment area, use of multiple blocks; 20 MeV or greater

77412 G6011 Radiation treatment delivery,3 or more separate treatment areas, custom blocking, tangential ports, wedges, rotational beam, compensators, electron beam; up to 5MeV

77413 G6012 Radiation treatment delivery,3 or more separate treatment areas, custom blocking, tangential ports, wedges, rotational beam, compensators, electron beam; 6-10MeV

77414 G6013 Radiation treatment delivery,3 or more separate treatment areas, custom blocking, tangential ports, wedges, rotational beam, compensators, electron beam; 11-19MeV

77416 G6014 Radiation treatment delivery,3 or more separate treatment areas, custom blocking, tangential ports, wedges, rotational beam , compensators, electron beam; 20MeV or greater

77418 G6015 Intensity modulated treatment delivery, single or multiple fields/arcs,via narrow spatially and temporally modulated beams, binary, dynamic MLC, per treatment session

0073T G6016 Compensator-based beam modulation treatment delivery of inverse planned treatment using 3 or more high resolution (milled or cast) compensator, convergent beam modulated fields, per treatment session

0197T G6017 Intra-fraction localization and tracking of target or patient motion during delivery of radiation therapy(eg,3D positi onal tracking, gating, 3D su rface tracking), each fraction of treatment

(13) Breast Tomosynthesis (C PT codes 77061, 77062, and 77063) For CY 2015, the CPT Editorial Panel created three codes to describe digital breast tomosynthesis services: 77061 (Dig ital breast tomosynthesis; uni lateral), 77062 (Digital breast

2 This chart only contains CY 2014 codes for which a HCPCS code is being used for CY 2015. Addendum B contains a complete list of CPT and HCPCS codes being recognized by Medicare under the PFS for CY 2015.CMS-1612-FC 366 tomosynthesis; bilateral) and 77063 (Screening digital breast to mosynthesis, bilateral (List separately in addition to code for primary procedure) and we received RUC recommendations for these codes. Currently, th ese services are reported to Medicare using G0202, G0204, and G0206, which describe the equivalent procedures us ing any digital technology (2-D or 3-D). In addition, film mammography is reported to Medicare using CPT codes 77055, 77056 and 77057). In the proposed rule, based upon our belief that digital mammography is now typical, we proposed to replace the G-codes that currently describe all di gital mammography services under Medicare with the CPT codes, to value the CPT codes for CY 2015 based upon the current Gcode values, and to include the CPT codes on the potentially misvalued code list since the resources involved in furnishing these services ha d not been evaluated in more than a decade. Having reassessed the proposal in light of the new codes and RUC recommendations for tomosynthesis and the comments received upon our proposal, we are fi nalizing a modified proposal. For a discussion of our proposal, a su mmary of the comments we received, and our policy for CY 2015, see section II.B.4. With regard to screening mammography, the CPT coding system now has an add-on CPT code for tomosynthesis. This coding scheme is consistent with the FDA requiring a 2-D mammography when tomosynthesis is used for screening purposes. Accordingly, we will recognize CPT code 77063 to be reported, when tomosynthesis is used in addition to 2-D mammography. Since CPT code 77063 is an add-on code, and does not have an equivalent CY 2014 code, we believe it is appropriate to valu e it on an interim final basis in advance of receiving the RUC recommendations for other mammography services. We are assigning it a

CY 2015 interim final work RVU of 0.60 as recommended by the RUC.CMS-1612-FC 367 Whenever feasible, it is our strong preference to value entire families together in order to

avoid rank order anomalies. In this final rule with comment period, we are including the codes for digital mammography on the potentially misv alued code list, which currently include tomosynthesis as well as 2-D mammography. Accordingly, we will wait to value the new diagnostic mammography tomosynt hesis codes until we have received recommendations from the RUC for all mammography services, In the in terim, we are assigning a PFS indicator of “I” to 77061 and 77062. Those furnishing diagnostic mammography using tomosynthesis will continue to report G0204 and G 0206 as appropriate. In addition, we are creating a new code, G2079 (Diagnostic digital breast tomos ynthesis, unilateral or bilatera l (List separately in addition to G0204 or G0206)) as an add-on code that should be reported in additio n to the relevant 2-D diagnostic mammography G-code to recognize the additional reso urces involved in furnishing diagnostic breast tomosynthesis. We will assi gn it the same inputs as CPT code 77063 because

we believe it describes a similar service. (14) Isodose Calculati on with Isodose Planning Bundle (CPT Code 77316) For CY 2015, the CPT Editorial Panel replaced six CPT codes (77305, 77310, 77315, 77326, 77327, and 77328) with five new CPT codes to bundle basic dosimetry calculation(s) with teletherapy and brac hytherapy isodose planning. We are establishing the RUCrecommended work RVUs for CY 2015 for all of the codes in this family except CPT code 77316. We disagree with the RUC-recommended cr osswalk for this service because we do not believe it is an appropriate match in work. The RUC crosswalked CPT code 77318 to CPT code 77307, both of which are complex isodose planning c odes in the same family. We believe that the RUC should have crosswalked CPT code 77316, a simple isodose planning code, to the corresponding simple isodose planning code in the same family, CPT code 77306. Therefore, for CY 2015 we are establishing an interim final work R VU of 1.40 for CPT code 77316.CMS-1612-FC 368 (15) Immunohistochemistry (CPT co des 88341, 88342, and 88344; HCPCS codes G0461 and G0462)

In the CY 2014 PFS final rule with comment period (78 FR 74341), we assigned a status indicator of I (Not vali d for Medicare purposes) to CPT codes 88341, 88342, and 88343 and instead created two G-codes, G0461 and G0462, to report immunohistochemistry services. We did this in part to avoid cr eating incentives for overutilizat ion. For CY 2015, the CPT coding

was revised with the creation of two new CP T codes, 88341 and 88344, the revision of CPT code

88342 and the deletion of CPT code 88343. We be lieve that the revised coding structure

addresses the concerns that we had with the CY 2014 coding regarding the creation of incentives and overutilization. Accordingly, we are deleting the G-codes and assigning interim final values

for these CPT code codes for CY 2015. We ar e establishing the RUC-recommended work RVUs

as interim final for CY 2015 for CPT codes 88342 and 88344. In the past for similar procedures in this family, the RUC recommended a work RVU for the add-on code that was 60 per cent of the base code. For example, the RUC-recommended work RVU for CPT code 88334 (Pathology consulta tion during surgery; cytologic examination (for example, touch prep, squash prep), each add itional site (List separately in addition to code for primary procedure)) is 60 percent of the work RVU of the base CPT code 88333 (Pathology consultation during surgery; cytologic examination (f or example, touch prep, squash prep), initial site). Similarly, the RUC-recommended work RVU for CPT code 88177 (Cytopathology, evaluation of fine needle aspi rate; immediate cytohi stologic study to determine adequacy for diagnosis, each separate additional evaluation epis ode, same site (List separately in addition to code for primary procedure)) is 60 percent of the recommended value for the base CPT code 88172 (Cytopathology, evaluation of fine needle as pirate; immediate cyto histologic study to determine adequacy for diagnosis, first evaluatio n episode, each site). We believe that theCMS-1612-FC 369

relative resources involved in fu rnishing an add-on service in this family would be reflected appropriately using the same 60 percent metr ic. To value CPT code 88341, we calculated 60 percent of the work RVU of the base CPT code 88342, which has a work RVU of 0.70; resulting

in a work RVU of 0.42 for CPT code 88341. (16) Morphometric Analysis In Situ Hybridization for Gene Rearrangement(s) (CPT Codes 88364, 88365, 88366, 88368, 88369, 88373, and 88374 and 88377) For CY 2014, the in situ hybridizatio n procedures, CPT codes 88365, 88367 and 88368, were revised to specify “each separately identif iable probe per block;” three new add-on codes (CPT codes 88364, 88373, 88369) were created to specify “each additional separately identifiable probe per slide;” and three new code s were created to specify “each multiplex probe stain procedure.” We are establishing the RU C-recommended work RVUs as interim final for CY 2015 for CPT codes 88365, 88366, 88368, and 88377. CPT code 88367 is the computer assisted vers ion of morphometric analysis, analogous to

88368 which is the manual version. We have accepted the RUC recommended work RVU of

0.88 for 88368 which has 30 minutes of intraservi ce time. CPT code 88367 only has 25 minutes

of intraservice time and we do not believe that the RUC recomme nded work RVU of 0.86 adequately reflects that change in time. We be lieve that the ratio of the intraservice times (25/30) applied to the work RVU (0.88) adequately reflects the difference in work. Therefore, we are assigning an interim final work RVU to CPT code 88367 of 0.73. Similarly, CPT code 88374 is the computer as sisted version of CPT code 88377 but with a drop in intraservice time from 45 minutes to 30 minutes. We believe appl ying this ratio to the work RUV of 88377 more accurately reflects the wor k. Therefore, we are assigning an interim

final work RVU to CPT code 88374 of 0.93.CMS-1612-FC 370 As discussed in the previous section, some of the add-on codes in this family had RUCrecommended work RVUs that were 60 percent of the work RVU of the base procedure and we applied that reduction to 88341. We believe this accurately reflects th e resources used in furnishing these add-on codes. Accordingly, we used this methodology to establish interim final work RVUs of 0.53 for code 88364 (60 percent of the work RVU of CPT code 88365); 0.53 for CPT code 88369 (60 percent of the work R VU of CPT code 88368); and 0.43 for CPT code 88373 (60 percent of the work RVU of CPT code 88367). (17) Electro-oculography (EOG VNG) CPT Codes 92270, 92540, 92541, 92542, 92544, 92543, and 92545)

After the RUC identified CPT code 92543 as potentially misvalued through the CMSOther Source – Utilization over 250,000 screen, CPT revised the pare ntheticals for this code for

CY 2015. We received RUC recomme ndations for CY 2015 for this code and other codes in the family. We are assigning the RUC-reco mmended work values for CPT codes 92270, 92540, 92541, 92542, 92544, and 92545. For CPT code 92543, however, we have been informed by the RUC that survey respondents may not have unde rstood the revised code description for CPT code 92543, and thus the survey data may be unre liable. As a result, we believe the most accurate information upon which to base work RVUs for CPT code 92543 is its existing work RVU. Therefore, we are establishing a work RVU of 0.10 for CPT code 92543 as interim final

for CY 2015. (18) Interventional Transe sophageal Echocardiography (TEE) (CPT Codes 93312, 93313, 93314, 93315, 93316, 93317, 93318, 93355, and 93644) For CY 2015, CPT code 93355 was create d to describe transesophageal echocardiography during interventional ca rdiac procedures. The RUC provided recommendations for CPT code 93355, and for CP T codes 93312-93318 in order to ensure intra-CMS-1612-FC 371 family relativity. We are establishing the RU C-recommended work RVU of 2.40 as interim final

for CY 2015 for CPT code 93318 and 4.66 for CPT code 93355.

The RUC based the work RVU for CPT code 93312 upon a crosswalk to CPT code 43247 (Esophagogastroduodenoscopy, flexible, transo ral; with removal of foreign body). This code has significant differences from CPT code 93312. We have been unable to identify a CPT

code with 30 minutes of intraservice time and 60 minutes of total time with a work RVU higher

than 2.55. We believe this service is more similar to CPT code 75573 (Computed tomography, heart, with contrast material, for evaluation of cardiac structure and morpho logy in the setting of congenital heart disease (incl uding 3D image postprocessing, asse ssment of LV cardiac function,

RV structure and function and evaluation of venous structures, if performed) since it has similar work, time and the same global period. Based upon this crosswalk, we are assigning CPT code

93312 a CY 2015 interim final work RVU of 2.55. Due to CPT descriptor for CPT code 93315, we be lieve that the appropriate work for this

service is reflected in the combined work of CPT codes 93316 and 93317, resulting in a CY 2015

interim final work RVU of 2.94. For CPT codes 93313, 93314, 93316 and 93317, we are assigning CY 2015 interim final work RVUs based upon the 25th percentile va lues from the survey: 0.51 for CPT code 93313, 2.10 for CPT code 93314, 2.94 for CPT code 93315, 0.85 for CPT code 93316, 2.09 for CPT code 93317, and 4.66 for CPT code 93355. Each of these codes had a significant drop in

intraservice time since the last valuation and RU C recommendations for higher work RVUs. As

we have stated in the absence of informati on showing a change in intensity, we believe meaningful changes in time should be reflected in the work RVUs. For these codes, we believe the 25th percentile survey values better describe the work and time involved in these procedures than the RUC recommendations and also help ma intain appropriate relativity in the family.CMS-1612-FC 372 Additionally, we are refining the preservice and intraservice times for CPT codes 93314 and 93317 to 10 and 20 minutes, respectively, to main tain relativity among th e interim final work

RVUs and times. (19) Subcutaneous Implantable Defibr illator Procedures (CPT Codes 33270, 33271, 33272, 33272, 93260, 93261 and 93644) For CY 2015, the CPT Editorial Panel added th e word “implantable” to the descriptors for several codes in this family and cr eated several new codes, CPT codes 33270, 33271, 33272, 33272, 93260, 93261 and 93644. We received RUC reco mmendations for the new and revised codes. We are establishing the RUC-recommende d work RVUs for all of the codes in this family except CPT code 93644. This code has an intraservice time of 20 minutes and a total

time of 84 minutes. We disa gree with the RUC-recommended crosswalk for CPT code 93644

which has an intraservice time of 29 minutes and a total time of 115 minu tes and believe that a

crosswalk to CPT code 32551 would be better as that code’s intraservice time is 20 minutes and the total time is 83 minutes. Therefore, we ar e establishing a CY 2015 in terim final work RVU

of 3.29 for CPT code 93644. (20) Duplex Scans (CPT Codes 93886, 93888, 93926, 93975, 93976, 93977, 93978, and 93979)

In the CY 2013 PFS final rule with comment period, we requested that the RUC assess the relativity among the entire family of duplex scans codes and recommend appropriate work RVUs. CMS also requested th at the RUC consider CPT c odes 93886, Transcranial Doppler study of the intracranial arteries; complete study, and 93888, Tr anscranial Doppler study of the intracranial arteries; limited study, in conjunction with the duplex scan codes in order to assess the relativity between and among those codes. The RUC reviewed this entire family of codes and provided recommendations for CY 2015. For CY 2015, we are es tablishing the RUC-CMS-1612-FC 373 recommended work RVUs as interim final for all of the codes in the family except CPT codes 93886, 93888, 93926, 93975, 93976, 93977, 93978, and 93979. For several codes in this family with 10 minutes of intraservice time, the RUC

recommended 0.50 work RVUs. We believe that th is relationship between intraservice time and work RVU accurately reflects the time and intensity involved, and should be used for the majority of the codes in the family. As a result, for CPT codes 93926, 93979, and 93888, which all have 10 minutes of intraservice time, we ar e assigning an interim fi nal work RVU of 0.50. For several codes in this family with 15 minute of intraservice time, the RUC recommended work RVUs based upon the survey 25th percentile. We find th is to appropriately reflect the work involved. Accordingly, for CPT codes 93975, 93976, and 93978, which all have 15 minutes of intraservice time, we are disagr eeing with the RUC work RVU recommendations and assigning the 25th percentile of the survey as CY 2015 interim final values. Therefore, for CY 2015 we are establishing the following inte rim final work RVUs: 1.16 for CPT code 93975, 0.80 for CPT code 93976, 0.80 for CPT code 93978 and 0.50 for CPT code 93979. Lastly, we believe that the RUC recomme ndation for CPT code 93886 overvalues the work involved. We accepted the RUC recommendation for CPT code 93880 of 0.80 with an

intraservice time of 15 minutes. CPT code 93886 has an intraservice time of 17 minutes. Applying the work RVU to time ratio of CPT co de 93880 to the intraservice time of CPT code 93886 (results in our interim final value of 0.91 for CPT code 93886. (21) Carotid Intima-Media Thic kness Ultrasound (C PT Code 93895) For CY 2015, a new code, CPT code 93895, de scribes the work of using carotid ultrasound to measure atherosclerosis and quantify the intima-media thickness. After review of this code, we determined that it is used only fo r screening and therefore, we are assigning a PFS procedure status indicator of N (Non covered service) to CPT code 93895.CMS-1612-FC 374 (22) Doppler Flow Testing (CPT Code 93990) For CY 2015, the RUC provided a recomme ndation for CPT code 93990 which had been identified through the High Volume Growth Servi ces where Medicare uti lization increased by at least 100 percent from 2006 to 2011. The RU C recommended a work RVU of 0.60 for this service. Due to the similarity of this service to duplex scans, we are establishing RVUs for CPT code 93990 that are consistent with duplex scans with 10 minutes of intraservice time; which we

discussed above in section E .4.18. We assigned it an interim final work RVU of 0.50. (23) Electronic analysis of implante d neurostimulator (CPT Codes 95971 and 95972) For CY 2015, the RUC reviewed CPT codes 95971 and 95972 because they were identified by the High Volume Growth Services screen which identifies services in which Medicare utilization increased by at least 100 percent from 2006 to 2011 screen. It is unclear to us why CPT code 95973, the add-on code to CPT code 95972, was not also surveyed. We are valuing CPT code 95971 based upon the RU C recommended wo rk RVU of 0.78. For CPT code 95972, we do not believe that the RUC recommended change in work RVU from 1.50 to 0.90 reflects the much more signi ficant change in intraservice time from 60 minutes to 23 minutes. Therefore, we used a building block methodology to develop a work

RUV of 0.80. Even though the RUC did not survey 95973, we believe we should review it as part of this family. Not having a survey or RUC recommendations, we belie ve that the percent decrease

in the work RVU from the base code 95972 shoul d apply to this code. Therefore, we are establishing an interim final work RVU of 0.49 for CPT code 95973. We note that the descriptor for CPT code 95972 was changed from “...first hour” to “...up to one hour.” We note that for Medicare pu rposes this code shoul d only be billed when aCMS-1612-FC 375 majority of an hour is completed. We would also note that the add- on code should only be reported after a full 60 minutes of service is furnished. The lack of a survey for CPT code 95973 al ong with the confusing descriptor language and intraservice time suggest the need for this fam ily to be returned to CPT for clarification of the descriptor and then to the RUC for resurvey. (24) Negative Pressure Wound Therapy (CPT Codes 97607, and 97608, and HCPCS codes G0456 and G0457) Prior to CY 2013, the codes used to report negative pressure wound therapy were CPT codes 97605 and 97606, both of which were typica lly reported in conjunction with durable medical equipment that was paid separately. In the CY 2013 final rule with comment period, we created two HCPCS codes to pr ovide a payment mechanism for negative pressure wound therapy services furnished to beneficiaries using equipm ent that is not paid for as durable medical equipment: G0456 (Negative pressure wound therapy, (for example, vacuum assisted drainage collection) using a mechanically-powered devi ce, not durable medical equipment, including provision of cartridge and dressing(s), topical ap plication(s), wound assessment, and instructions for ongoing care, per session; total wound(s) su rface area less than or equal to 50 square centimeters) and G0457 (Negative pressure wound therapy,(for example, vacuum assisted drainage collection) using a mechanically-pow ered device, not durable medical equipment, including provision of cartridge and dressing(s), topical appli cation(s), wound assessment, and instructions for ongoing care, per session; total wound(s) surface area greate r than 50 sq cm). For CY 2015, two new codes, CPT codes 97607 and 97608, were created to describe negative pressure wound therapy with the use of a disposable system. In addition, CPT codes 97605 and 97606 were revised to specify the use of durable medical equipment. Based upon these the revised coding scheme for negative pr essure wound therapy, we are deleting theCMS-1612-FC 376 G-codes. We are contractor pricing thes e codes for CY 2015. CPT codes 97607 and 97608 will be designated “Sometimes Thera py” on our Therapy Code List, wh ich is consistent with the Gcodes. The Therapy Code List is available at http://www.cms.gov/Medicare/Billing/TherapySer vices/index.html?redir ect=/therapyservices .” (25) Application of Topical Fl uoride Varnish (CPT Code 99188)

CPT Code 99188 is a new code for CY 2015 th at describes the application of topical

fluoride varnish to teeth. Since this code describes a service that involves th e care of teeth, it is excluded from coverage under Medicare by sec tion 1862(a)(12) of the Act, which provides

“items and services in connection with the ca re, treatment, filling, removal, or replacement of teeth, or structures directly supporting the teet h are excluded from coverage.” Accordingly, we are assigning a PFS procedure status indicator of N (Noncovered service) to CPT code 99188. (26) Advance Care Planning (CPT codes 99497 and 99498) For CY 2015, the CPT Editorial Panel created two new codes descri bing advance care planning services: CPT code 99497 (Advance car e planning including th e explanation and

discussion of advance directives such as standa rd forms (with completion of such forms, when performed), by the physician or other qualified hea lth professional; first 30 minutes, face-to-face with the patient, family member(s) and/or su rrogate); and an add-CP T code 99498 (Advance care planning including the explanation a nd discussion of advance directives such as standard forms (with completion of such forms, when performe d), by the physician or other qualified health professional; each additional 30 minutes (List se parately in addition to code for primary procedure)). For CY 2015, we are assigning a PFS st atus indicator of “I” (N ot valid for Medicare purposes. Medicare uses another co de for the reporting and paymen t of these services.) to CPT codes 99497 and 99498 for CY 2015. However, we will consider whether to pay for CPT codesCMS-1612-FC 377 99497 and 99498 after we have had the opportu nity to go through notice and comment rulemaking. c. Establishing Interim Final Direct PE RVUs for CY 2015 i. Background and Methodology The RUC provides CMS with recommendations regarding direct PE inputs, including clinical labor, dispos able supplies, and medi cal equipment, for new, revised, and potentially

misvalued codes. We review the RUC-recommende d direct PE inputs on a code-by-code basis, including the recommended facility PE inputs an d/or nonfacility PE inputs. This review is informed by both our clinical a ssessment of the typical resour ce requirements for furnishing the service and our intention to maintain the principl es of accuracy and relativity in the database. We determine whether we agree with the RUC's recommended direct PE inputs for a service or, if we disagree, we refine the PE inputs to repres ent inputs that better re flect our estimate of the PE resources required to furnish the service in the fac ility and/or nonfacility settings. We also confirm that CPT codes should have facility and/or nonfacility direct PE inputs and make changes based on our clinical judgment and any PFS payment policies that would apply to the

code. We have accepted for CY 2015, as interim fina l and without refinement, the direct PE inputs based on the recommendations submitted by the RUC for the codes listed in Table 28.

For the remainder of the RUC's direct PE recommendations, we have accepted the PE recommendations submitted by the RUC as interim fi nal, but with refinements. These codes and

the refinements to their direct PE inputs are listed in Table 31.

We note that the final CY 2015 PFS direct PE input database reflects the refined direct PE inputs that we are adopting on an interim final basis for CY 2015. That database is available

under downloads for the CY 2015 PFS final rule with comment period on the CMS website atCMS-1612-FC 378 http://www.cms.gov/Medicare/Medicare-Fee-fo r-Service-Payment/PhysicianFeeSched/PFSFederal-Regulation-Notices.html . We also note that the PE RVUs displayed in Addenda B and C reflect the interim final values and policies desc ribed in this section. All PE RVUs adopted on an interim final basis for CY 2015 are included in Addendum C and are open for comment in this final rule with comment period.CMS-1612-FC 379

TABLE 28: CY 2015 INTERI M FINAL CODES WITH DIRECT PE INPUT RECOMMENDATIONS ACCEPTED WITHOUT REFINEMENT

HCPCS Short Descriptor 11980 Implant hormone pellet(s) 22512 Vertebroplasty addl inject 22515 Perq vertebral augmentation 22856 Cerv artific diskectomy 27280 Fusion of sacroiliac joint 31620 Endobronchial us add-on 33270 Ins/rep subq defibrillator 33271 Insj subq impltbl dfb elctrd 33272 Rmvl of subq defibrillator 33273 Repos prev impltbl subq dfb 33951 Ecmo/ecls insj prph cannula 33952 Ecmo/ecls insj prph cannula 33953 Ecmo/ecls insj prph cannula 33954 Ecmo/ecls insj prph cannula 33955 Ecmo/ecls insj ctr cannula 33956 Ecmo/ecls insj ctr cannula 33957 Ecmo/ecls repos perph cnula 33958 Ecmo/ecls repos perph cnula 33959 Ecmo/ecls repos perph cnula 33962 Ecmo/ecls repos perph cnula 33963 Ecmo/ecls repos perph cnula 33964 Ecmo/ecls repos perph cnula 33969 Ecmo/ecls rmvl perph cannula 33984 Ecmo/ecls rmvl prph cannula 33985 Ecmo/ecls rmvl ctr cannula 33986 Ecmo/ecls rmvl ctr cannula 33988 Insertion of left heart vent 33989 Removal of left heart vent 36818 Av fuse uppr arm cephalic 36819 Av fuse uppr arm basilic 36820 Av fusion/forearm vein 36821 Av fusion direct any site 36825 Artery-vein autograft 36830 Artery-vein nonautograft 36831 Open thrombect av fistula 36832 Av fistula revision open 36833 Av fistula revision 37218 Stent placemt ante carotid 43180 Esophagoscopy rigid trnso 52441 Cystourethro w/implant 55840 Extensive prostate surgery 55842 Extensive prostate surgery 55845 Extensive prostate surgery 58541 Lsh uterus 250 g or less 58542 Lsh w/t/o ut 250 g or less 58543 Lsh uterus above 250 g HCPCS Short Descriptor 58544 Lsh w/t/o uterus above 250 g 58570 Tlh uterus 250 g or less 58571 Tlh w/t/o 250 g or less 58572 Tlh uterus over 250 g 58573 Tlh w/t/o uterus over 250 g 64486 Tap block unil by injection 64487 Tap block uni by infusion 64488 Tap block bi injection 64489 Tap block bi by infusion 66179 Aqueous shunt eye w/o graft 66180 Aqueous shunt eye w/graft 66184 Revision of aqueous shunt 66185 Revise aqueous shunt eye 67036 Removal of inner eye fluid 67039 Laser treatment of retina 67040 Laser treatment of retina 67041 Vit for macular pucker 67042 Vit for macular hole 67043 Vit for membrane dissect 67255 Reinforce/graft eye wall 70496 Ct angiography head 70498 Ct angiography neck 76770 Us exam abdo back wall comp 76775 Us exam abdo back wall lim 76856 Us exam pelvic complete 76857 Us exam pelvic limited 77080 Dxa bone density axial 77316 Brachytx isodose plan simple 77317 Brachytx isodose intermed 77318 Brachytx isodose complex 88348 Electron microscopy 88356 Analysis nerve 91200 Liver elastography 92145 Corneal hysteresis deter 92541 Spontaneous nystagmus test 92542 Positional nystagmus test 92544 Optokinetic nystagmus test 92545 Oscillating tracking test 93260 Prgrmg dev eval impltbl sys 93261 Interrogate subq defib 93644 Electrophysiology evaluation 97610 Low frequency non-thermal usCMS-1612-FC 380

ii. Common Refinements

Table 31 details our refinements of the RUC' s direct PE recommendations at the code-specific level. In this section, we discu ss the general nature of some common refinements and the reasons for particular refinements. (a) Changes in Physician Time Some direct PE inputs are dire ctly affected by revisions in work time described in section II.E.3.a. of this final rule with comment period. We note that for many codes, changes in the intraservice portions of the work time and changes in the number or level of postoperative visits included in the global periods result in correspondi ng changes to direct PE inputs. We also note that, for a significant number of services, es pecially diagnostic tests, the procedure time assumptions used in determining direct PE input s are distinct from, and therefore not dependent on, work intraservice time assumptions. For thes e services, we do not make refinements to the direct PE inputs based on changes to estimated work intraservice times. Changes in Intraservice Work Time in the Nonf acility Setting. For mo st codes valued in the nonfacility setting, a portion of the clinical labor time alloca ted to the intraservice period reflects minutes assigned for assistin g the practitioner with the proced ure. To the extent that we are refining the times associated with the intr aservice portion of such procedures, we have adjusted the corresponding intr aservice clinical labor minutes in the nonfacility setting. For equipment associated with the intras ervice period in the n onfacility setting, we generally allocate time based on the typical numbe r of minutes a piece of equipment is being used, and therefore, not available for use with an other patient during that period. In general, we allocate these minutes based on the description of t ypical clinical labor activities. To the extent that we are making changes in the clinical labor times associated with the intraservice portion of procedures, we have adjusted the corresponding e quipment minutes associated with the codes.CMS-1612-FC 381 Changes in the Number or Level of Post operative Office Visits in the Global Period

. For codes valued with postservice office visits during a global period, most of the clinical labor time allocated to the postservice period reflects a stan dard number of minutes allocated for each of

those visits. To the extent that we are refini ng the number or level of postoperative visits, we

have modified the clinical sta ff time in the postservice period to reflect the change. We note that until the global periods are transitioned, consistent with other policies finalized in this rule, we

will make these refinements. For codes valu ed with postservice office visits during a global period, we allocate standard equipment for each of those visits. To the extent that we are making a change in the number or level of postoperative visits associated with a code, we have adjusted the corresponding equipment minutes. For codes va lued with postservice office visits during a global period, a certain number of supply items are allocated for each of those office visits. To the extent that we are making a change in the num ber of postoperative visi ts, we have adjusted the corresponding supply item quantities associated with the codes. We note that many supply items associated with postservice office visits ar e allocated for each office visit (for example, a minimum multi-specialty visit pack (SA048) in th e CY 2015 direct PE input database). For these supply items, the quantities in the direct PE i nput database should reflect the number of office

visits associated with the code 's global period. However, some supply items are associated with postservice office visits but are only allocate d once during the global period because they are typically used during only one of the postservi ce office visits (for example, pack, post-op incision care (suture) (SA054) in the direct PE input database). For these supply items, the quantities in the direct PE input data base reflect that single quantity.

These refinements are reflected in the fi nal CY 2015 PFS direct PE input database and

detailed in Table 31. (b) Equipment MinutesCMS-1612-FC 382 In general, the equipment time inputs reflect the sum of the times w ithin the intraservice period when a clinician is using the piece of equi pment, plus any additional time the piece of equipment is not available for use for anothe r patient due to its us e during the designated procedure. In cases where equipment times included time for clinical labor activities in the preservice period, we have refined these times to remove th e minutes associated with these tasks, since the pre-service period ends “when patient enters office/facility for surgery/procedure.” Although some services include equi pment that is typically unavaila ble during the entire clinical labor service period, certain highl y technical pieces of equipment and equipment rooms are less likely to be used by a clinician for all tasks associ ated with a service, and therefore, are typically available for other patients dur ing the preservice and postservi ce components of the service period. We adjust those equipment times accordingl y. We refer interested stakeholders to our extensive discussion of these policies in the CY 2012 PFS final rule with comment period (76 FR 73182-73183) and in section II.G.2.b. of this final rule with comment period. We are refining

the CY 2015 RUC direct PE recommendations to conform to these equipment time policies.

These refinements are reflected in the final CY 2015 PFS direct PE input database and detailed

in Table 31. (c) Moderate Sedation Inputs In the CY 2012 PFS final rule (76 FR 73043-73049) , we finalized a standard package of direct PE inputs for services wher e moderate sedation is considered inherent in the procedure. In

section II.A. of this final rule with comment period, we finalized a refinement to the standard package to include a stretcher for the same lengt h of time as the other equipment items in the standard package. We are refining the CY 2015 RU C direct PE recommenda tions to conform to these policies. This includes the removal of a power table where it was included during theCMS-1612-FC 383 intraservice period, as the stretche r takes the place of the table. These refinements are reflected in the final CY 2015 PFS direct PE input database and detailed in Table 31. (d) Standard Minutes fo r Clinical Labor Tasks In general, the preservice, intraservice pe riod, and postservice clinical labor minutes associated with clinical labor inpu ts in the direct PE input databa se reflect the sum of particular tasks described in the information that accompanies the recommended direct PE inputs on “PE worksheets.” For most of these described tasks, there are a standardized number of minutes, depending on the type of procedure, its typical se tting, its global period, an d the other procedures with which it is typically reported. At times, the RUC recommends a numb er of minutes either greater than or less than the time typically allotted for certa in tasks. In those cases, CMS r eviews

the deviations from the standard s to assess whether they are clin ically appropriate. Where the RUC-recommended exceptions are not accepted, we re fine the interim final direct PE inputs to

match the standard times for those tasks. In add ition, in cases when a serv ice is typically billed with an E/M or other evaluation service, we remove the preservice clinical labor tasks so that the inputs are not duplicative and reflect the resource costs of furnishing th e typical service.

In some cases the RUC recommendations include additional minutes described by a category called “other clinical activity,” or throu gh the addition of clinical labor tasks that are different from those previously included as stan dard. In these instances, CMS reviews the tasks

as described in the recommendation to determine wh ether they are already incorporated into the

total number of minutes based on the standard ta sks. Additionally, CMS reviews these tasks in

the context of the kinds of tasks delineated for ot her services under the PFS. For those tasks that are duplicative or not separately incorporated for other services, we do not accept those additional clinical labor tasks as direct inputs. For example, as we have previously discussed (78 FR 74308), we believe that quality assurance docu mentation tasks for services across the PFS areCMS-1612-FC 384 already accounted for in the overall estimate of c linical labor time. We do not believe that it would serve the relativity of the direct PE input database were additional minut es added for each clinical task that could be discretely described for every code. These refinements are reflected in the final CY 2015 PFS direct PE input da tabase and detailed in Table 31. (e) New Supply and Equipment Items The RUC generally recommends the use of suppl y and equipment items that already exist in the direct PE input database for new, re vised, and potentially misvalued codes. Some recommendations include supply or equipment items that are not currently in the direct PE input database. In these cases, the RUC has historic ally recommended a new item be created and has facilitated CMS's pricing of that item by working with the specialty societies to provide sales

invoices to us. We received invoices for several new suppl y and equipment items for CY 2015. We have accepted the majority of these items and added them to the direct PE input database. Tables

29 and 30 detail the invoices received for new and existing items in the direct PE database. As

discussed in section II.A. of this final rule with comment perio d, we encourage stakeholders to review the prices associated with these new and existing items to determine whether these prices appear reasonable. Where prices appear unreas onable, we encourage st akeholders to provide invoices that provide more accurate pricing for thes e items in the direct PE database. We remind stakeholders that due to the budge t neutral nature of the PFS, increased prices for any items in

the direct PE database decrease the pool of PE RVUs available to all other PFS services. Tables

29 and 30 also include the number of invoices received as well as the number of nonfacility allowed services for procedures that use these equipment items. In cases where large numbers of allowed services exist, we question pricing the item based upon a single invoice. We areCMS-1612-FC 385 concerned that the single invoice may not be re flective of typical costs for these items and encourage stakeholders to provide additional invoices. In some cases we cannot adequately price a newly recommended item due to inadequate information. In some cases, no supporting inform ation regarding the price of the item has been

included in the recommendation to create a new it em. In other cases, th e supporting information

does not demonstrate that the ite m has been purchased at the lis ted price (for example, price quotes instead of paid invoices). In cases where the information provided allowed us to identify clinically appropriate proxy items, we have used existing items as proxies for the newly recommended items. In other cases, we have in cluded the item in the dire ct PE input database without an associated price. Although including the item without an associated price means that

the item does not contribute to th e calculation of the PE RVU for pa rticular services, it facilitates our ability to incorporate a pri ce once we are able to do so.CMS-1612-FC 386TABLE 29: INVOICES RECEIVED FOR NEW DIRECT PE INPUTSCPT/HCPCSCodesItem Name CMS code Average PriceNumber ofInvoicesNon-Facility Allowed Services forHCPCS Codes Using This Item (orProjected Services for New CPTCodes*)20604,20606, 20611ultrasound transmission gel, sterile(single use)SJ089 $1.71 1 748248*22512 10g IVAS drill SD292 $139.33 1 99*22512 10g cannulae SD293 $86.11 1 99*29200,29240,29260,29280,29520,29530,29540, 29550foam underwrap SG097 $0.0043 per inch 1 41551329200,29240,29260,29280,29520,29530,29540, 29550rigid strapping tape (15 yards) SG098 $0.018 per inch 1 41551329200,29240,29260,29280,29520,29530,29540, 29550skin prep barrier wipes SM029 $0.20 1 41551331620Flexible dual-channeled EBUSbronchoscope, with radial probeEQ361 $160,260.06 6 107CMS-1612-FC 387CPT/HCPCSCodesItem Name CMS code Average PriceNumber ofInvoicesNon-Facility Allowed Services forHCPCS Codes Using This Item (orProjected Services for New CPTCodes*)31620Video system, Ultrasound(processor, digital capture,monitor, printer, cart)ER099 $13,379.57 6 10731620EBUS, single use aspirationneedle, 21 gSC102 $145.82 5 10731620Balloon for BronchosopyFiberscopeSD294 $28.68 4 10752441, 52442Urolift Implant and implantationdeviceSD291 $775.00 10 12*64486, 64488 ultrasound needle SC101 $12.81 4 46851*64487, 64489continuous peripehral nerve blocktraySA116 $23.69 1 802*77063 multimodality software ED051 $11,570.00 12 297529*88341 Anti CD45 Monoclonal Antibody SL495 $3.61 per test 1 917673*88344 34 Beta E12 SL496 $4.27 per test 1 51591*88348 Digital Printer ED048 $774.89 1 64188348 Carbon Coater EQ366 $22,540.08 1 64188348 Diamond Milling ToolEQ365 $1,714.00 1 64188356, 88348Electron Microscopy TissueprocessorEP115 $13,119.00 2 1913488356, 88348 Block face milling machine EQ363 $18,139.00 1 1913488356, 88348 Glass Knife Breaker EQ364 $9,585.14 1 1913488364 CMV DNA Probe Cocktail SL500 $0.10 per ul 1 3376*CMS-1612-FC 388CPT/HCPCSCodesItem Name CMS code Average PriceNumber ofInvoicesNon-Facility Allowed Services forHCPCS Codes Using This Item (orProjected Services for New CPTCodes*)88341,88342,88344,88364,88365,88367,88368,88369, 88373Universal Detection Kit SA117 $4.00 1 138059788365 EBER positive control slide SL507 $20.15 1 844088365 (EBER) DNA Probe Cocktail SL497 $8.57 per test 2 844088365,88366,88367,88368,88374, 88377VP-2000 Processor EP116 $30,800.00 1 22824388367, 88368 Kappa Probe Cocktails SL498 $0.10 per ul 1 3663488369, 88373 Lambda Probe Cocktail SL499 $0.10 per ul 1 24423*88380, 88381Surface Decontaminant (DNAAway)SL494 $0.07 per ml 1 664991200 Fibroscan ER101 $124,950.00 1 87*92145 Ocular Response Analyzer EQ360 $12,000.00 3 Unknown92541,92542,92544, 92545VNG Recording System EQ367 $29,607.50 2 10113993702BIS monitoring system(bioimpedance spectroscopy)EQ359 $3,316.93 1 UnknownCMS-1612-FC 389CPT/HCPCSCodesItem Name CMS code Average PriceNumber ofInvoicesNon-Facility Allowed Services forHCPCS Codes Using This Item (orProjected Services for New CPTCodes*)93702electrode, BIS (bioimpedancespectroscopy)SD290 $28.33 1 Unknown96127Beck Youth Inventory, SecondEdition (BYI-II); CombinationInventory BookletSK119 $1.96 per booklet 1 Unknown97610 MIST Therapy System EQ372 $28,000.00 2 2*97610 MIST Therapy Cart EQ368 $1,250.00 1 2*97610kit, low frequency ultrasoundwound therapy (MIST)SA119 $63.33 3 2*99188 CavityShield 5% Varnish .25mL SH106 $0.91 1 UnknownG0277HBOT air break breathingapparatus demand system (hoses,masks, penetrator and demandvalve)EQ362 $986.00 1 153044*CMS-1612-FC 390TABLE 30: INVOICES RECEIVED FOR EXISTING DIRECT PE INPUTSCPT/HCPCSCodesItem NameCMScodeCurrentPriceUpdatedPrice%ChangeNumberofInvoicesNon-facilityAllowedServices forHCPCScodes usingthis item20983, 47383 cryosurgery system (for tumor ablation) EQ302 missing $37,500.002 22*20983, 47383 gas, argon SD227$0.25 percubic foot$0.32 percubic foot28% 1 22*20983, 47383 gas, helium SD079$0.25 percubic foot$0.57 percubic foot128% 1 22*31627system, navigational bronchoscopy(superDimension)EQ326 $137,800.00 $189,327.6637% 4 3731627kit, locatable guide, ext. working channel,w-b-scope adapterSA097 $995.00 $1,063.677% 3 3764561 kit, percutaneous neuro teststimulation SA022 $305.00 $420.0038% 1 822988348camera, digital system, for electronmicroscopyED006 $41,000.00 $82,000.00100% 1 64188348, 88356 microtome, ultra ER043 $25,950.00 $34,379.0032% 1 19134G0277HBOT (hyperbaric oxygen therapy)monochamber, incl. gurney and integratedgrounding assemblyEQ131 $125,000.00 $127,017.982% 1 153044**New procedure - Projected volumeCMS-1612-FC 391

(f) Recommended Items that are not Direct PE Inputs In some cases, the recommended direct PE i nputs included items that are not clinical labor, disposable supplies, or medical equipment resources. We have a ddressed these kinds of recommendations in previous rulemaking and in s ections II.G.2.b. and II.B.4.a . of this final rule with comment period. Refinements to adjust for these recommended inputs are reflected in the final CY 2015 PFS direct PE input data base and detailed in Table 31. (g) Film-to-digital Migration

As discussed in section II.A.3 of this fina l rule with comment pe riod, we are finalizing our policy to remove equipment and supply input s associated with film technology from the

direct PE database. Since the recommendations we received for 2015 were prepared before the transition occurred, in some cases, the RUC r ecommendations included film inputs. Where recommendations included these inputs, we have removed these inputs and replaced them with “PACS workstation proxy” as described in secti on II.A.3 of this final rule with comment period. Since the film-to-digital transition results fr om our acceptance of a RUC recommendation, we do

not consider the removal of these items to be refinements of RU C recommendations, and

therefore do not include them in Table 31. (h) Pre-service and post-service tasks for Add-on codes In general, we believe that certain pre-service and post-serv ice tasks are not repeated for services reported using add-on codes. In some cases, we also believe that the time for certain equipment items are not duplicated for add-on co des. In these cases, we removed the time associated with those tasks and/or equipment ite ms from those codes. These refinements appear

in Table 31. iii. Code-Specific RefinementsCMS-1612-FC 392 (a) Rib Fractures (CPT codes 21811, 21812, and 21813) For the newly created rib fracture codes, wh ich are frequently furnished as emergency surgeries, the RUC did not include time for the standard pre-service act ivities “Provide preservice education/obtain consent” and “Follow-up phone calls & pr escriptions.” However, the

RUC recommendation included time for pre-service activities “C omplete pre-service diagnostic & referral forms,” “Coordinate pre-surgery serv ices”, and “Schedule space and equipment in facility.” Since these codes w ould typically be provided as em ergency surgeries, we question

whether these tasks would t ypically be performed. We reviewed other emergency procedures in the PFS to determine whether pre-service

clinical labor activ ities were typically included in th e PE worksheets. We found that the recommendations for these procedures were inconsistent. Therefore, we will not remove the time

allocated for these clinical labor activities at th is time. However, we believe that for emergency procedures, none of the pre-serv ice tasks listed above would t ypically be performed. We seek comment to clarify this issue, and plan to consider this issue in future rulemaking.

As discussed earlier in this section of this final rule with comment period, we have valued CPT codes 21811, 21812, and 21813 as 0-day globals. We have therefore removed direct PE inputs associated with th e postoperative visits. (b) Percutaneous Vertebroplasty an d Augmentation (CPT codes 22510, 22511, 22512, 22513, 22514, and 22515) The RUC recommendation regarding add-on CPT code 22512 (Percutaneous vertebroplasty (bone biopsy included when pe rformed), 1 vertebral body, unilateral or bilateral injection, inclusive of all imaging guidance, each addi tional cervicothoracic or lumbosacral vertebral body)) included new supply item “10g I VAS drill.” We note that the recommendations

for the base codes did not contai n this supply item, and the vertebroplasty kit does not appear toCMS-1612-FC 393

contain this drill either. We do not understa nd why the drill would be required for the add-on code when it is not required for the base code . Therefore, we will not include supply item “10g

IVAS drill” in CPT code 22512 at this time. (c) Endobronchial Ultrasound (EBUS) (CPT code 31620)

As indicated earlier in this section of this final rule with comment period, we are maintaining the CY 2014 work RVU for CPT code 31620 in light of our concerns regarding coding structure. As such, we are maintaining the CY 2014 direct PE inputs for 31620 as well. (d) Breast Tomosynthesis (CPT codes 77061, 77062, and 77063) For CY 2015, the CPT Editorial Panel created three codes to describe digital breast tomosynthesis services: 77061(Digi tal breast tomosynthesis; uni lateral), 77062 (Digital breast tomosynthesis; bilateral) and 77063 (Screening digital breast to mosynthesis, bilateral (List separately in addition to code for primary procedure)). For thes e newly created codes, the RUC recommended creating a new equipment item, “r oom, breast tomosynthesis”, at a price of $667,669, as well as a list of items c ontained in the room. We believe that several of the items included in the room are not appropr iately characterized as direct co sts. We also believe that the

creation of rooms sometimes causes confusion when items in the room are also included as stand-alone PE inputs, as specia lty societies do not consider the items included in the room when preparing the PE worksheets. Further, we believe that the prices for the rooms sometimes result in less transparency, as prices for items within the room tend to remain static over time. Therefore, we are not creating this new equipmen t item, but will instead include the individual equipment items that we believe are appropr iately characterized as direct costs. The price for the digital breast tomosynthesis unit indicated on the invoice received by the RUC was $498,412. We received many invoices fo r this equipment item with an average price of $381,380. Therefore, we w ill create a new equipment item “DBT unit”, at a price ofCMS-1612-FC 394 $381,380. The RUC also recommended including a new equipment item, “PACS cache”, for these procedures. We do not believe th at digital storage constitutes a direct cost, as it is not individually allocable to an individual patient for a particular service. . Therefore, we will not add this new equipment item to the direct PE database. (e) Radiation Treatment (CPT codes 77385, 77386, 77387, 77402, 77407, 77412) For CY 2015, the CPT Editorial Panel revised the set of codes that describe radiation treatment delivery services. These revisions incl uded the addition and deletion of several codes and the development of new guidelines and coding instructions. Due to the significant code restructuring and potential for changes in payment, some specialty societies representing providers of radiation treatment services have re quested that we delay implementation of the new code set. We believe that given the large scale of the changes in this code set restructuring, in the context of our upcoming revised process for va luing new, revised, and potentially misvalued codes, it is prudent to propose the values for the revised code set in the CY 2016 rule with opportunity for public comment prior to establishing payment rates. (f) Immunohistochemistry (CPT codes 88341, 88342, and 88344) The RUC recommended including supply it em “UltraView Universal DAB Detection Kit” (SL488) for CPT codes 88341, 88342, and 88344, which is priced at $10.49 per kit, and “UltraView Universal Alkaline Phosphatase Red Detection Kit”, which is priced at $20.64. We

noted that for other similar serv ices, CPT codes 88364, 88365, 88367, 88368, 88369, and 88373, the RUC recommended including supply item “Uni versal Detection Kit” (SA117), which is priced at $4.00 per kit. After reviewing information about thes e two kits, we believe that functions provided by SL488 and SL489 are also provided by SA117. The recommendations did not explain why the more expensive kit was necessary for 88341, 88342, and 88344 when theCMS-1612-FC 395 less expensive kit was sufficient for CPT codes 88364, 88365, 88367, 88368, 88369, and 88373. Absent any rationale for the use of the more expensive kit, we are including SA117 for 88341, 88342, and 88344 in place of SL488. (g) Electron Microscopy (CPT code 88348) The RUC recommended including a new suppl y item, “diamond milling tool”, for use with CPT code 88348. However, upon reviewing the invoice, we believe that “diamond milling tool” is more appropriately char acterized as equipment. We have therefore created an equipment item for this tool, as listed in Table 29. (h) Morphometric Analysis (CPT codes 88364, 88365, 88366, 88367, 88373, 88374, 88377, 88368, and 88369)

The CPT Editorial Panel revised the in situ hybrid ization codes (88365, 88367, and 88368) and created three new add-on codes for re porting each additional se parately identifiable probe per slide. The RUC reviewed CP T codes 88365, 88367, and 88368, among other services in this family, in October 2013 and recommended direct inputs for these procedures, including supply item “kit, FISH paraffin pretreatment” (S L195), with quantities of 1 unit for CPT code 88365, 0.75 units for CPT code 88367, and 1 unit for CPT code 88368.

After the CY 2014 PFS final rule with comment period was published, the specialty

societies determined that additional clarificat ion was necessary, and re quested that the CPT Editorial Panel review the entire family again. The CPT editorial pane l added three new codes for “each multiplex probe stain procedure.” The specialty societies then resurveyed these procedures. The RUC reviewed the entire fam ily at the April 2014 m eeting and recommended supply item SL195 with a quantity of 2 units for CPT code 88365, 1.4 units for CPT code 88367, and 2 units for CPT code 88368. These quantities are double what the RUC recommended to us in October 2013, which was 1 unit for CPT code 88365, 0.75 units for CPT code 88367, and oneCMS-1612-FC 396 unit for CPT code 88368. Without an explanation fo r this significant change, we are including SL195 with the following quantities: 1 unit for CPT code 88365, 0.75 units for CPT code 88367, and 1 unit for CPT code 88368. Similarly, for add-on services CPT codes 88364, 88366, 88369, 88373, 88374, and 88377, more than one unit of SL195 wa s included. We believe that the unit

of the kit should be consistent between the base code and the add-on code. We will therefore include 1 unit of SL195 for CPT codes 88364, 88366, 88369, and 88377, and 0.75 units for CPT

codes 88373 and 88374. We are also interested in learning more about why a partial kit would be used in furnishing the typical service. CPT codes 88374 and 88377, which are add-on codes, contain more than one unit of supply item “kit, HER-2/neu DNA Probe” (SL196). Because these codes desc ribe a service that includes a single specimen with one stain, we do not understand why more than one kit would be required. We have therefore included a unit of 1 for SL196 in CPT codes 88374 and 88377. We also believe that the units of positive co ntrol slides and negativ e control slides should be consistent throughout this entire fam ily. We note that CPT codes 88367, 88373, and 88374 included a recommended 0.2 units of positive and/ or negative control slide; supply items SL118 and SL119 for CPT code 88367, supply items SL120 and SL121 for CPT code 88373, and supply items SL184 and SL185 for CPT code 88374.) However, for CPT codes 88368, 88369, and 88377, the recommendation included 0.5 units of the positive and/or negative control slide (supply item SL112 for CPT codes 88368 and 88369, and supply items SL184 and SL185 for CPT code 88377). No rationale was provided for why a greater quantity of the control slide would be required. Therefore, we will include 0.2 units of positive and/or negative control slides, as appropriate, to ma intain consistency throughout th is family of codes. As with the positive and negative control slid es, we believe that the number of units of supply item SL498 (“Kappa probe cocktails”) an d SL499 (Lambda probe cocktails”) should beCMS-1612-FC 397 consistent across procedures. The recomme ndations for CPT codes 88367 and 88373 contain 28

ul of SL498 for 88367 and 27 ul of SL499 for 88373. Therefore, to maintain consistency, we

refined the units of SL498 for CPT code 88368 and SL499 for CPT code 88369 to 28 ul. The RUC recommended a quantity of 1.6 for SL497 “(EBER) DNA Probe Cocktail” for CPT code 88365. Since this procedure describes a single stain, and the stain needs to be added to the positive control slide and the specimen slide, we believe that a quantity of 2 is more appropriate. We have ther efore included 2 units of SL497 for CPT code 88365.

The RUC recommendation also included a new equipment item “VP-2000 processor” (EP116). Among the purposes of this equipment item is to reduce the amount of technician time needed to complete the clinical labor task. Howe ver, in the recommendati ons we received, rather

than the clinical labor time for these codes de creasing with the addition of this new equipment item, the RUC recommended increased clinical labor times associated with this task for CPT codes 88365, 88366, 88368, and 88377 increased. We are unable to reconcile as typical the new equipment item, which is intended to reduce technician time, with the increased technician timefor this same clinical labor task. Therefore, we will not allocate time for equipment item “VP2000 processor” (EP116) in CPT codes 88365, 88366, 88368, and 88377. (h) Microdissection (CPT codes 88380 and 88381) In reviewing the RUC recommendations for CPT code 88380, the work vignette

indicated that the microdissec tion is performed by the pathologi st. However, the PE worksheet

also included several subtasks of “Microdissect each stained slide sequentially while reviewing

H and E stained slide” that are performed by the cytotechnologist. Since we do not believe that both the pathologist and the cytot echnologist are completing these ta sks, we have refined out the lines associated with the specific tasks we be lieve are completed by the pathologist. Table 31

details our refinements to the clinical labor tasks.CMS-1612-FC 398 (j) Interventional Transesophageal Echo cardiography (TEE) (CPT codes 93312 and 93314)

CPT code 93314 describes a service in which th e acquisition and interpretation of images is furnished by a different practitioner than the placement of the probe. CPT code 93312 includes all services encompassed by CPT code 93314 and included a recommendation for 30 minutes of

assist physician time. We do not believe that CPT code 93314 should have more clinical labor than CPT code 93312, which is the more extensive c ode. We have therefore refined this time to 30 minutes, which is the same as the time a llocated to 93312. We also note that the time allocated to equipment item “room, ultras ound, vascular” (EL016) was affected by this

refinement. (k) Hyperbaric Oxygen Therapy (HBOT) (HCPCS code G0277)

We received a RUC recommendation for CP T code 99183 (Physician or other qualified health care professional attenda nce and supervision of hyperbaric oxygen therapy, per session), which included significant increases to the direct PE inputs, which assumes a treatment time of 120 minutes. Currently, CPT code 99183 is used for both the professional attendance and supervision and the actual treat ment delivery. Stakeholders ha ve pointed out that although we include the PE inputs for treatment delivery in this code, the descriptor describes only attendance and supervision. We note that under the OPPS, the treatment is reported using separate treatment code C1300 (Hyperbaric oxygen under pressure, full body chamber, per 30 minute interval). After consid ering this issue, we believe the OPPS approach would also be appropriate

for the PFS. We are therefore creating a G-code to report the treat ment delivery and to maintain consistency with the OPPS coding. We will use th e same descriptor as previously used for

OPPS code C1300 for a timed 30-minute code, which can then be used across settings. To value this G-code, we used the RUC recommended direct PE inputs for 99183 and adjusted them to align

with the 30 minute treatment interval.CMS-1612-FC 399 In reviewing the recommended direct PE i nputs, we observed that the quantity of oxygen increased significantly relative to the previous value. To better understand this change, we

reviewed the instruction manual for the most commonly used HBOT chamber, which provide guidance regarding the quantity of Oxygen use d. Based on our review, we determined that 12,000, rather than 47,000, was the typical number of units. Therefore, in aligning the direct PE inputs as described above, we first adjusted the units of oxygen to 12,000 for the recommended 120 minute time, and subsequently adjusted it to align with the 30 minute G-code. (l) EOG VNG (CPT code 92543)

As described earlier in this section of th is final rule with comment period, we are maintaining the CY 2014 work RVU for CPT code 92543 due to possible confusion among survey respondents. Similarly, we are also maintaining the CY 2014 direct PE inputs for 92543. These refinements, as well as other appli cable standard and common refinements for these codes, are reflected in the final CY 2015 PFS direct PE input database and detailed in

Table 31.CMS-1612-FC 400TABLE 31: CY 2015 INTERIM FINALCODES WITH DIRECT PE INPUT RECOMMENDATIONS ACCEPTEDWITH REFINEMENTSHCPCSCodeHCPCS CodeDescriptionInputCodeInput CodeDescriptionNF/F/ POLabor Activity(where applicable)RUCRecommendation orcurrent value(min or qty)CMSRefinement(min orqty)CommentDirectCostsChange20604Drain/injjoint/bursa w/usL037D RN/LPN/MTA F Conduct phonecalls/call inprescriptions3 0 Typically billed with an E/Mservice$-1.11L037D RN/LPN/MTA NF Conduct phonecalls/call inprescriptions3 0 Typically billed with an E/Mservice$-1.1120606Drain/injjoint/bursa w/usL037D RN/LPN/MTA F Conduct phonecalls/call inprescriptions3 0 Typically billed with an E/Mservice$-1.11L037D RN/LPN/MTA NF Conduct phonecalls/call inprescriptions3 0 Typically billed with an E/Mservice$-1.1120611Drain/injjoint/bursa w/usL037D RN/LPN/MTA F Conduct phonecalls/call inprescriptions3 0 Typically billed with an E/Mservice$-1.11L037D RN/LPN/MTA NF Conduct phonecalls/call inprescriptions3 0 Typically billed with an E/Mservice$-1.1120983Ablate bonetumor(s) perqEF018 stretcher NF 60 193 Standard equipment and timefor moderate sedation$0.68EF027 table, instrument,mobileNF 134 193 Standard equipment and timefor moderate sedation$0.08EL007 room, CT NF 134 133 Refined equipment time toconform to establishedpolicies for highly technicalequipment.$-4.87EQ011 ECG, 3-channel(with SpO2,NIBP, temp,resp)NF 194 193 Standard equipment and timefor moderate sedation$-0.01CMS-1612-FC 401HCPCSCodeHCPCS CodeDescriptionInputCodeInput CodeDescriptionNF/F/ POLabor Activity(where applicable)RUCRecommendation orcurrent value(min or qty)CMSRefinement(min orqty)CommentDirectCostsChangeEQ032 IV infusionpumpNF 194 193 Standard equipment and timefor moderate sedation$-0.01EQ168 light, exam NF 194 133 Refined equipment time toconform to establishedpolicies for non-highlytechnical equipment.$-0.26EQ302 cryosurgerysystem (fortumor ablation)NF 134 133 Refined equipment time toconform to establishedpolicies for highly technicalequipment.$-0.1021811Optx of rib fxw/fixj scopeL037D RN/LPN/MTA F Discharge daymanagement99238 --12minutes12 0 Post-operative visits removed;see preamble text.$-4.44EF014 light, surgical PO 72 0 Post-operative visits removed;see preamble text.$-0.72EF031 table, power PO 72 0 Post-operative visits removed;see preamble text.$-1.18SA048 pack, minimummulti-specialtyvisitPO 2 0 Post-operative visits removed;see preamble text.$-2.29SA052 pack, post-opincision care(staple)PO 1 0 Post-operative visits removed;see preamble text.$-5.0621812Treatment of ribfractureL037D RN/LPN/MTA F Discharge daymanagement99238 --12minutes12 0 Post-operative visits removed;see preamble text.$-4.44EF014 light, surgical PO 99 0 Post-operative visits removed;see preamble text.$-0.99EF031 table, power PO 99 0 Post-operative visits removed;see preamble text.$-1.62SA048 pack, minimummulti-specialtyvisitPO 3 0 Post-operative visits removed;see preamble text.$-3.43CMS-1612-FC 402HCPCSCodeHCPCS CodeDescriptionInputCodeInput CodeDescriptionNF/F/ POLabor Activity(where applicable)RUCRecommendation orcurrent value(min or qty)CMSRefinement(min orqty)CommentDirectCostsChangeSA052 pack, post-opincision care(staple)PO 1 0 Post-operative visits removed;see preamble text.$-5.0621813Treatment of ribfractureL037D RN/LPN/MTA F Discharge daymanagement99238 --12minutes12 0 Post-operative visits removed;see preamble text.$-4.44EF014 light, surgical PO 99 0 Post-operative visits removed;see preamble text.$-0.99EF031 table, power PO 99 0 Post-operative visits removed;see preamble text.$-1.62SA048 pack, minimummulti-specialtyvisitPO 3 0 Post-operative visits removed;see preamble text.$-3.43SA052 pack, post-opincision care(staple)PO 1 0 Post-operative visits removed;see preamble text.$-5.0622513Perq vertebralaugmentationSA053 pack, post-opincision care(suture & staple)NF 1 0 No justification provided foruse of staple and suture pack.Suture pack sufficient in thetypical procedure.$-6.11SA054 pack, post-opincision care(suture)NF 0 1 No justification provided foruse of staple and suture pack.Suture pack sufficient in thetypical procedure.$4.9122514Perq vertebralaugmentationSA053 pack, post-opincision care(suture & staple)NF 1 0 No justification provided foruse of staple and suture pack.Suture pack sufficient in thetypical procedure.$-6.11SA054 pack, post-opincision care(suture)NF 0 1 No justification provided foruse of staple and suture pack.Suture pack sufficient in thetypical procedure.$4.91CMS-1612-FC 403HCPCSCodeHCPCS CodeDescriptionInputCodeInput CodeDescriptionNF/F/ POLabor Activity(where applicable)RUCRecommendation orcurrent value(min or qty)CMSRefinement(min orqty)CommentDirectCostsChange27279Arthrodesissacroiliac jointL037D RN/LPN/MTA F Discharge daymanagement99238 --12minutes12 6 Aligned clinical labordischarge day managementtime with the work timedischarge day code.$-2.2229200Strapping ofchestL023A Physical TherapyAideNF Greet patient andprovide gowning3 0 Typically billed with an E/Mor other evaluation service$-0.6929240Strapping ofshoulderL023A Physical TherapyAideNF Greet patient andprovide gowning3 0 Typically billed with an E/Mor other evaluation service$-0.6929260Strapping ofelbow or wristL023A Physical TherapyAideNF Greet patient andprovide gowning3 0 Typically billed with an E/Mor other evaluation service$-0.6929280Strapping ofhand or fingerL023A Physical TherapyAideNF Greet patient andprovide gowning3 0 Typically billed with an E/Mor other evaluation service$-0.6929520 Strapping of hipL023A Physical TherapyAideNF Greet patient andprovide gowning3 0 Typically billed with an E/Mor other evaluation service$-0.6929530Strapping ofkneeL023A Physical TherapyAideNF Greet patient andprovide gowning3 0 Typically billed with an E/Mor other evaluation service$-0.6929540Strapping ofankle and/or ftL023A Physical TherapyAideNF Greet patient andprovide gowning3 0 Typically billed with an E/Mor other evaluation service$-0.6929550Strapping oftoesL023A Physical TherapyAideNF Greet patient andprovide gowning3 0 Typically billed with an E/Mor other evaluation service$-0.6931627NavigationalbronchoscopyEF027 table, instrument,mobileNF 45 30 Standard equipment and timefor moderate sedation$-0.02EQ011 ECG, 3-channel(with SpO2,NIBP, temp,resp)NF 45 30 Standard equipment and timefor moderate sedation$-0.21CMS-1612-FC 404HCPCSCodeHCPCS CodeDescriptionInputCodeInput CodeDescriptionNF/F/ POLabor Activity(where applicable)RUCRecommendation orcurrent value(min or qty)CMSRefinement(min orqty)CommentDirectCostsChangeEQ032 IV infusionpumpNF 45 30 Standard equipment and timefor moderate sedation$-0.09L047C RN/RespiratoryTherapistNF Prepare andposition pt/monitor pt/ set upIV2 0 Add-on code; no additionaltime required to prepare andposition patient$-0.9433418Repair tcatmitral valveL037D RN/LPN/MTA F Discharge daymanagement99238 --12minutes12 0 Aligned clinical labordischarge day managementtime with the work timedischarge day code.$-4.44L037D RN/LPN/MTA F Discharge daymanagement99239 -- 15minutes0 15 Aligned clinical labordischarge day managementtime with the work timedischarge day code.$5.5533965Ecmo/ecls rmvlperph cannulaL051A RN F Schedule spaceand equipment infacility0 5 Standard inputs for procedureswith 90 day global periods$2.5533966Ecmo/ecls rmvlprph cannulaL051A RN F Schedule spaceand equipment infacility0 5 Standard inputs for procedureswith 90 day global periods$2.5536475Endovenous rf1st veinEF019 stretcher chair NF 30 31 Refined equipment time toconform to clinical labor time.$0.0136476Endovenous rfvein add-onEL015 room,ultrasound,generalNF 32 30 Refined equipment time toconform to changes in clinicallabor time.$-2.80EQ215 radiofrequencygenerator(vascular)NF 32 30 Refined equipment time toconform to changes in clinicallabor time.$-0.19L054A VascularTechnologistNF Reviewexamination withinterpreting MD1 0 Add-on code; no additionaltime required for clinical labortasks associated with digitalimaging$-0.54CMS-1612-FC 405HCPCSCodeHCPCS CodeDescriptionInputCodeInput CodeDescriptionNF/F/ POLabor Activity(where applicable)RUCRecommendation orcurrent value(min or qty)CMSRefinement(min orqty)CommentDirectCostsChangeL054A VascularTechnologistNF Technologist QCsimages USmachine,checking for allimages, reformats,and dose page1 0 Add-on code; no additionaltime required for clinical labortasks associated with digitalimaging$-0.5436478Endovenouslaser 1st veinEF019 stretcher chair NF 30 31 Refined equipment time toconform to clinical labortime.$0.0136479Endovenouslaser vein addonEL015 room,ultrasound,generalNF 32 30 Refined equipment time toconform to changes in clinicallabor time.$-2.80EQ160 laser,endovascularablation (ELVS)NF 32 30 Refined equipment time toconform to changes in clinicallabor time.$-0.33L054A VascularTechnologistNF Reviewexamination withinterpreting MD1 0 Add-on code; no additionaltime required for clinical labortasks associated with digitalimaging$-0.54L054A VascularTechnologistNF Technologist QCsimages USmachine,checking for allimages, reformats,and dose page1 0 Add-on code; no additionaltime required for clinical labortasks associated with digitalimaging$-0.5447383Perq abltj lvrcryoablationEF018 stretcher NF 240 166 Standard equipment and timefor moderate sedation$-0.39EF027 table, instrument,mobileNF 104 166 Standard equipment and timefor moderate sedation$0.09EQ011 ECG, 3-channel(with SpO2,NIBP, temp,resp)NF 164 166 Standard equipment and timefor moderate sedation$0.03EQ032 IV infusion NF 164 166 Standard equipment and time $0.01CMS-1612-FC 406HCPCSCodeHCPCS CodeDescriptionInputCodeInput CodeDescriptionNF/F/ POLabor Activity(where applicable)RUCRecommendation orcurrent value(min or qty)CMSRefinement(min orqty)CommentDirectCostsChangepump for moderate sedationEQ168 light, exam NF 164 106 Refined equipment time toconform to establishedpolicies for non-highlytechnical equipment.$-0.2552442Cystourethrow/addl implantEF027 table, instrument,mobileNF 0 25 No equipment times wereincluded; aligned equipmenttime with assist physiciantime.$0.04EF031 table, power NF 0 25 No equipment times wereincluded; aligned equipmenttime with assist physiciantime.$0.41EQ170 light, fiberopticheadlight wsourceNF 0 25 No equipment times wereincluded; aligned equipmenttime with assist physiciantime.$0.20ES018 fiberscope,flexible,cystoscopyNF 0 25 No equipment times wereincluded; aligned equipmenttime with assist physiciantime.$1.07ES031 video system,endoscopy(processor,digital capture,monitor, printer,cart)NF 0 25 No equipment times wereincluded; aligned equipmenttime with assist physiciantime.$3.2262284Injection formyelogramEF018 stretcher NF 60 48 Refined equipment time toconform to establishedpolicies for non-highlytechnical equipment.$-0.06CMS-1612-FC 407HCPCSCodeHCPCS CodeDescriptionInputCodeInput CodeDescriptionNF/F/ POLabor Activity(where applicable)RUCRecommendation orcurrent value(min or qty)CMSRefinement(min orqty)CommentDirectCostsChange62302MyelographylumbarinjectionL037D RN/LPN/MTA NF Assist physicianin performingprocedure26 13 All clinical labor activitieswere assgined to L037D.Reassigned imaging tasks toL041B.$-4.81L041B RadiologicTechnologistNF Assist physicianin performingprocedure0 13 All clinical labor activitieswere assgined to L037D.Reassigned imaging tasks toL041B.$5.3362303MyelographylumbarinjectionEF018 stretcher NF 60 64 Refined equipment time toconform to establishedpolicies for non-highlytechnical equipment.$0.02L037D RN/LPN/MTA NF Assist physicianin performingprocedure25 13 All clinical labor activitieswere assgined to L037D.Reassigned imaging tasks toL041B.$-4.44L041B RadiologicTechnologistNF Assist physicianin performingprocedure0 12 All clinical labor activitieswere assgined to L037D.Reassigned imaging tasks toL041B.$4.9262304MyelographylumbarinjectionEF018 stretcher NF 60 59 Refined equipment time toconform to establishedpolicies for non-highlytechnical equipment.$-0.01L037D RN/LPN/MTA NF Assist physicianin performingprocedure25 13 All clinical labor activitieswere assgined to L037D.Reassigned imaging tasks toL041B.$-4.44L041B RadiologicTechnologistNF Assist physicianin performingprocedure0 12 All clinical labor activitieswere assgined to L037D.Reassigned imaging tasks toL041B.$4.9262305MyelographylumbarinjectionEF018 stretcher NF 60 64 Refined equipment time toconform to establishedpolicies for non-highly$0.02CMS-1612-FC 408HCPCSCodeHCPCS CodeDescriptionInputCodeInput CodeDescriptionNF/F/ POLabor Activity(where applicable)RUCRecommendation orcurrent value(min or qty)CMSRefinement(min orqty)CommentDirectCostsChangetechnical equipment.L037D RN/LPN/MTA NF Assist physicianin performingprocedure30 15 All clinical labor activitieswere assgined to L037D.Reassigned imaging tasks toL041B.$-5.55L041B RadiologicTechnologistNF Assist physicianin performingprocedure0 15 All clinical labor activitieswere assgined to L037D.Reassigned imaging tasks toL041B.$6.1564561ImplantneuroelectrodesEQ202 percutaneousneuro teststimulatorNF 0 65 Neuro test stimulator isrequired to completePercutaneous implanation ofneurostimulator$0.17SB012 drape, sterile, forMayo standNF 1 0 Duplicative; Item included inpercutaneous neuro teststimulation kit (SA022).$-1.69SG074 steri-strip (6 stripuou)NF 1 0 Duplicative; Item included inpercutaneous neuro teststimulation kit (SA022).$-1.12SJ043 povidoneswabsticks (3pack uou)NF 1 0 Duplicative; Item included inpercutaneous neuro teststimulation kit (SA022).$-0.4170486Ct maxillofacialw/o dyeL041B RadiologicTechnologistNF Patient clinicalinformation andquestionnairereviewed bytechnologist,order fromphysicianconfirmed andexam protocoledby radiologist3 2 Standard times for clinicallabor tasks associated withdigital imaging$-0.41CMS-1612-FC 409HCPCSCodeHCPCS CodeDescriptionInputCodeInput CodeDescriptionNF/F/ POLabor Activity(where applicable)RUCRecommendation orcurrent value(min or qty)CMSRefinement(min orqty)CommentDirectCostsChange70487Ct maxillofacialw/dyeL041B RadiologicTechnologistNF Patient clinicalinformation andquestionnairereviewed bytechnologist,order fromphysicianconfirmed andexam protocoledby radiologist3 2 Standard times for clinicallabor tasks associated withdigital imaging$-0.41L046A CT Technologist NF SVC Provide preserviceeducation/obtainconsent3 2 CT Angiography only requires2 minutes for this task;maintain consistency withinfamily$-0.4670488Ct maxillofacialw/o & w/dyeL041B RadiologicTechnologistNF Patient clinicalinformation andquestionnairereviewed bytechnologist,order fromphysicianconfirmed andexam protocoledby radiologist3 2 Standard times for clinicallabor tasks associated withdigital imaging$-0.41L046A CT Technologist NF SVC Provide preserviceeducation/obtainconsent3 2 CT Angiography only requires2 minutes for this task;maintain consistency withinfamily$-0.4674174Ct angioabd&pelvw/o&w/dyeL046A CT Technologist NF Availability ofprior imagesconfirmed3 2 Standard times for clinicallabor tasks associated withdigital imaging$-0.4676641Ultrasoundbreast completeEL015 room,ultrasound,generalNF 30 27 Refined equipment time toconform to establishedpolicies for highly technicalequipment.$-4.21CMS-1612-FC 410HCPCSCodeHCPCS CodeDescriptionInputCodeInput CodeDescriptionNF/F/ POLabor Activity(where applicable)RUCRecommendation orcurrent value(min or qty)CMSRefinement(min orqty)CommentDirectCostsChange76642Ultrasoundbreast limitedEL015 room,ultrasound,generalNF 28 20 Refined equipment time toconform to establishedpolicies for highly technicalequipment.$-11.21L046A CT Technologist NF Acquire images 15 10 Limited study takes less timeto complete than completestudy; used ratio of ultrasoundabdomen complete and limitedto adjust 15 to 10 minutes.$-2.3076942Echo guide forbiopsyL051B RN/DiagnosticMedicalSonographerNF Availability ofprior imagesconfirmed3 2 Standard times for clinicallabor tasks associated withdigital imaging$-0.5177061BreasttomosynthesisuniL043A MammographyTechnologistNF Availability ofprior imagesconfirmed3 2 Standard times for clinicallabor tasks associated withdigital imaging$-0.4377062BreasttomosynthesisbiL043A MammographyTechnologistNF Availability ofprior imagesconfirmed3 2 Standard times for clinicallabor tasks associated withdigital imaging$-0.4377063BreasttomosynthesisbiL043A MammographyTechnologistNF FederallyMandated MQSAActivitiesAllocated ToEachMammogram4 0 Add-on code; no additionaltime required for this task.$-1.7277085Dxa bonedensity studyER019 densitometryunit, fan beam,DXA (wcomputerhardward &software)NF 38 34 Refined equipment time toconform to changes in clinicallabor time.$-1.29L041B RadiologicTechnologistNF Technologist QCsimages in PACS,checking allimages, reformats,and dose page6 2 Standard times for clinicallabor tasks associated withdigital imaging$-1.64CMS-1612-FC 411HCPCSCodeHCPCS CodeDescriptionInputCodeInput CodeDescriptionNF/F/ POLabor Activity(where applicable)RUCRecommendation orcurrent value(min or qty)CMSRefinement(min orqty)CommentDirectCostsChange77086Fractureassessment viadxaER019 densitometryunit, fan beam,DXA (wcomputerhardward &software)NF 21 19 Refined equipment time toconform to changes in clinicallabor time.$-0.64L041B RadiologicTechnologistNF Technologist QCsimages in PACS,checking allimages, reformats,and dose page4 2 Standard times for clinicallabor tasks associated withdigital imaging$-0.8277300Radiationtherapy doseplanED011 computersystem, recordand verifyNF 5 0 Item was not previouslyincluded for this service;rationale for change notprovided. See 78 FR 74317 forfurther discussion.$-3.1077306Telethx isodoseplan simpleED011 computersystem, recordand verifyNF 5 0 Item was not previouslyincluded for this service;rationale for change notprovided. See 78 FR 74317 forfurther discussion.$-3.1077307Telethx isodoseplan cplxED011 computersystem, recordand verifyNF 5 0 Item was not previouslyincluded for this service;rationale for change notprovided. See 78 FR 74317 forfurther discussion.$-3.1088341Immunohistoantibody slideEP024 microscope,compoundNF 21 13 Decreasedphysician work for88341 to 60% of 88342; sameadjustment was made forequipment used by physician.$-0.30EP110 Freezer NF 1 0 Indirect Practice Expense. Notindividually allocable to aparticular patient for aparticular service$-0.02CMS-1612-FC 412HCPCSCodeHCPCS CodeDescriptionInputCodeInput CodeDescriptionNF/F/ POLabor Activity(where applicable)RUCRecommendation orcurrent value(min or qty)CMSRefinement(min orqty)CommentDirectCostsChangeSA117 UniversalDetection KitNF 0 2 Maintain consistency in thetype of universal detection kitwith remaining code-setswithin this family.$8.00SL488 UltraViewUniversal DABDetection KitNF 2 0 Maintain consistency in thetype of universal detection kitwith remaining code-setswithin this family.$-20.9788342Immunohistoantibody stainEP110 Freezer NF 1 0 Indirect Practice Expense. Notindividually allocable to aparticular patient for aparticular service$-0.02SA117 UniversalDetection KitNF 0 2 Maintain consistency in thetype of universal detection kitwith remaining code-setswithin this family.$8.00SL488 UltraViewUniversal DABDetection KitNF 2 0 Maintain consistency in thetype of universal detection kitwith remaining code-setswithin this family.$-20.9788344Immunohistoantibody slideEP110 Freezer NF 1 0 Indirect Practice Expense. Notindividually allocable to aparticular patient for aparticular service$-0.02EP112 BenchmarkULTRAautomated slidepreparationsystemNF 33 30 Multiplex service - 2 stains istypical; since single stainsrequires 15 minutes, 2 stainsrequires no more than 30minutes$-1.52SA117 UniversalDetection KitNF 0 4 Maintain consistency in thetype of universal detection kitwith remaining code-setswithin this family.$16.00CMS-1612-FC 413HCPCSCodeHCPCS CodeDescriptionInputCodeInput CodeDescriptionNF/F/ POLabor Activity(where applicable)RUCRecommendation orcurrent value(min or qty)CMSRefinement(min orqty)CommentDirectCostsChangeSL488 UltraViewUniversal DABDetection KitNF 2 0 Maintain consistency in thetype of universal detection kitwith remaining code-setswithin this family.$-20.97SL489 UtraViewUniversalAlkalinePhosphatase RedDetection KitNF 2 0 Maintain consistency in thetype of universal detection kitwith remaining code-setswithin this family.$-41.2888364Insituhybridization(fish)EP024 microscope,compoundNF 37 22 Decreasedphysician work for88341 to 60% of 88342; sameadjustment was made forequipment used by physician.$-0.56EP045 chamber,hybridizationNF 240 0 Add-on code. Base codeincludes the hybridizationchamber, which would be usedconcurrently for both stains$-5.51EP054 water bath, FISHprocedures (lab)NF 13 0 Add on code. Water bath isused concurrently for the basecode and add-on code$-0.09EP110 Freezer NF 1 0 Indirect Practice Expense. Notindividually allocable to aparticular patient for aparticular service$-0.02L037B HistotechnologistNF Cleanroom/equipmentfollowingprocedure(including anyequipmentmaintenance thatmust be done afterthe procedure)0.5 0 Add-on code. Additionalclinical labor time for postservice task not required. Seepreamble.$-0.19SB023 gloves, nonsterile, nitrileNF 0.25 0 Add-on code. Gloves are notchanged between base code$-0.05CMS-1612-FC 414HCPCSCodeHCPCS CodeDescriptionInputCodeInput CodeDescriptionNF/F/ POLabor Activity(where applicable)RUCRecommendation orcurrent value(min or qty)CMSRefinement(min orqty)CommentDirectCostsChangeand add-on codeSL189 ethanol, 100% NF 62.5 37.5 No rationale was provided forquantity change relative tocurrent value. Maintainingcurrent value.$-0.08SL195 kit, FISHparaffinpretreatmentNF 2 1 Maintain consistency in unitof the kit between base codeand add-on code. Seepreamble.$-20.85SL248 ethanol, 95% NF 62.5 37.5 No rationale was provided forquantity change relative tocurrent value. Maintainingcurrent value.$-0.0888365Insituhybridization(fish)EP110 Freezer NF 1 0 Indirect Practice Expense. Notindividually allocable to aparticular patient for aparticular service$-0.02EP116 VP-2000ProcessorNF 30 0 We are unable to reconcile thenew equipment item with theincreased technician time. Seepreamble.$-2.90SL189 ethanol, 100% NF 62.5 37.5 No rationale was provided forquantity change relative tocurrent value. Maintainingcurrent value.$-0.08SL195 kit, FISHparaffinpretreatmentNF 2 1 No rationale was provided forquantity change relative tocurrent value. Maintainingcurrent value.$-20.85SL248 ethanol, 95% NF 62.5 37.5 No rationale was provided forquantity change relative tocurrent value. Maintainingcurrent value.$-0.08CMS-1612-FC 415HCPCSCodeHCPCS CodeDescriptionInputCodeInput CodeDescriptionNF/F/ POLabor Activity(where applicable)RUCRecommendation orcurrent value(min or qty)CMSRefinement(min orqty)CommentDirectCostsChangeSL497 (EBER) DNAProbe CocktailNF 1.6 2 Stain needs to be added to thepositive control slide and thespecimen slide. See preamble.$3.4388366Insituhybridization(fish)EP088 ThermoBrite NF 2.5 0 This input is not containedwithin any other code in thisfamily. Maintainingconsistency with all othercodes within family.$-0.05EP110 Freezer NF 1 0 Indirect Practice Expense. Notindividually allocable to aparticular patient for aparticular service$-0.02EP116 VP-2000ProcessorNF 30 0 We are unable to reconcile thenew equipment item with theincreased technician time. Seepreamble.$-2.90L037B HistotechnologistNF Examine signalsin each cell andgenerate data forthe pathologist tointerpret20 15 Refined clinical labor time forthis multiplex procedure toreflect efficiencies inexamining two stains on asingle slide.$-1.85SL189 ethanol, 100% NF 62.5 37.5 No rationale was provided forquantity change relative tocurrent value. Maintainingcurrent value.$-0.08SL195 kit, FISHparaffinpretreatmentNF 2 1 Maintain consistency in unitof the kit between base codeand add-on code. Seepreamble.$-20.85SL248 ethanol, 95% NF 62.5 37.5 No rationale was provided forquantity change relative tocurrent value. Maintainingcurrent value.$-0.0888367InsituhybridizationEP110 Freezer NF 1 0 Indirect Practice Expense. Notindividually allocable to a$-0.02CMS-1612-FC 416HCPCSCodeHCPCS CodeDescriptionInputCodeInput CodeDescriptionNF/F/ POLabor Activity(where applicable)RUCRecommendation orcurrent value(min or qty)CMSRefinement(min orqty)CommentDirectCostsChangeautoparticular patient for aparticular serviceSL189 ethanol, 100% NF 31.25 18.75 No rationale was provided forquantity change relative tocurrent value. Maintainingcurrent value.$-0.04SL195 kit, FISHparaffinpretreatmentNF 1.4 0.75 No rationale provided forquantity change. Seepreamble.$-13.55SL248 ethanol, 95% NF 31.25 18.75 No rationale was provided forquantity change relative tocurrent value. Maintainingcurrent value.$-0.0488368InsituhybridizationmanualEP110 Freezer NF 1 0 Indirect Practice Expense. Notindividually allocable to aparticular patient for aparticular service$-0.02EP116 VP-2000ProcessorNF 30 0 We are unable to reconcile thenew equipment item with theincreased technician time. Seepreamble.$-2.90SL508 positive controlslide (proxy forKappa PositiveControl Slide)NF 0.5 0.2 Maintain consistency in unitof control slides within familyof codes. See preamble.$-3.54SL509 positive controlslide (proxy forKappa NegativeControl Slide)NF 0.5 0.2 Maintain consistency in unitof control slides within familyof codes. See preamble.$-3.54SL189 ethanol, 100% NF 37.5 18.75 No rationale was provided forquantity change relative tocurrent value. Maintainingcurrent value.$-0.06CMS-1612-FC 417HCPCSCodeHCPCS CodeDescriptionInputCodeInput CodeDescriptionNF/F/ POLabor Activity(where applicable)RUCRecommendation orcurrent value(min or qty)CMSRefinement(min orqty)CommentDirectCostsChangeSL190 ethanol, 70% NF 12.5 6.25 No rationale was provided forquantity change relative tocurrent value. Maintainingcurrent value.$-0.02SL191 ethanol, 85% NF 12.5 6.25 No rationale was provided forquantity change relative tocurrent value. Maintainingcurrent value.$-0.02SL195 kit, FISHparaffinpretreatmentNF 2 1 No rationale provided forquantity change. Seepreamble.$-20.85SL248 ethanol, 95% NF 37.5 18.75 No rationale was provided forquantity change relative tocurrent value. Maintainingcurrent value.$-0.06SL498 Kappa ProbeCocktailNF 40 28 Maintain consistency in unitof probe cocktails within thisfamily of codes. See preamble.$-1.1488369M/phmtrcalysishquant/semiqEP024 microscope,compoundNF 42 25 Refined equipment time forthis multiplex procedure toreflect efficiencies in timewhen examining two stains ona single slide.$-0.64EP045 chamber,hybridizationNF 240 0 Add-on code. Base codeincludes the hybridizationchamber, which would be usedconcurrently for both stains$-5.51EP054 water bath, FISHprocedures (lab)NF 13 0 Add on code. Water bath isused concurrently for the basecode and add-on code$-0.09EP110 Freezer NF 1 0 Indirect Practice Expense. Notindividually allocable to aparticular patient for aparticular service$-0.02CMS-1612-FC 418HCPCSCodeHCPCS CodeDescriptionInputCodeInput CodeDescriptionNF/F/ POLabor Activity(where applicable)RUCRecommendation orcurrent value(min or qty)CMSRefinement(min orqty)CommentDirectCostsChangeL037B HistotechnologistNF Cleanroom/equipmentfollowingprocedure(including anyequipmentmaintenance thatmust be done afterthe procedure)0.5 0 Add-on code. Additionalclinical labor time for postservice task not required. Seepreamble.$-0.19SB023 gloves, nonsterile, nitrileNF 0.25 0 Not necessary to changegloves between the slides inthe same procedure.$-0.05SL510 positive controlslide (proxy forLambda PositiveControl Slide)NF 0.5 0.2 Maintain consistency in unitof control slides within familyof codes. See preamble.$-3.54SL511 positive controlslide (proxy forLambdaNegative ControlSlide)NF 0.5 0.2 Maintain consistency in unitof control slides within familyof codes. See preamble.$-3.54SL189 ethanol, 100% NF 37.5 18.75 No rationale was provided forquantity change relative tocurrent value. Maintainingcurrent value.$-0.06SL195 kit, FISHparaffinpretreatmentNF 2 1 Maintain consistency in unitof the kit between base codeand add-on code. Seepreamble.$-20.85SL248 ethanol, 95% NF 37.5 18.75 No rationale was provided forquantity change relative tocurrent value. Maintainingcurrent value.$-0.06CMS-1612-FC 419HCPCSCodeHCPCS CodeDescriptionInputCodeInput CodeDescriptionNF/F/ POLabor Activity(where applicable)RUCRecommendation orcurrent value(min or qty)CMSRefinement(min orqty)CommentDirectCostsChangeSL499 Lambda ProbeCocktailNF 40 28 Maintain consistency in unitof probe cocktails within thisfamily of codes. See preamble.$-1.1488373M/phmtrc alysishquant/semiqEP024 microscope,compoundNF 42 25 Refined equipment time forthis multiplex procedure toreflect efficiencies in timewhen examining two stains ona single slide.$-0.64EP045 chamber,hybridizationNF 120 0 Add-on code. Base codeincludes the hybridizationchamber, which would be usedconcurrently for both stains$-2.75EP054 water bath, FISHprocedures (lab)NF 7 0 Add on code. Water bath isused concurrently for the basecode and add-on code$-0.05EP110 Freezer NF 1 0 Indirect Practice Expense. Notindividually allocable to aparticular patient for aparticular service$-0.02SB023 gloves, nonsterile, nitrileNF 0.125 0 Not necessary to changegloves between the slides inthe same procedure.$-0.02SL189 ethanol, 100% NF 31.25 18.75 No rationale was provided forquantity change relative tocurrent value. Maintainingcurrent value.$-0.04SL195 kit, FISHparaffinpretreatmentNF 1.4 0.75 Maintain consistency in unitof the kit between base codeand add-on code. Seepreamble.$-13.55SL248 ethanol, 95% NF 31.25 18.75 No rationale was provided forquantity change relative tocurrent value. Maintainingcurrent value.$-0.04CMS-1612-FC 420HCPCSCodeHCPCS CodeDescriptionInputCodeInput CodeDescriptionNF/F/ POLabor Activity(where applicable)RUCRecommendation orcurrent value(min or qty)CMSRefinement(min orqty)CommentDirectCostsChange88374M/phmtrc alysishquant/semiqEP110 Freezer NF 1 0 Indirect Practice Expense. Notindividually allocable to aparticular patient for aparticular service$-0.02SL030 cover slip, glass NF 2.8 1.4 Quantity of slides required forthis multiplex procedure doesnot differ from the singleprocedure (only number ofstains per slide differs).$-0.11SL189 ethanol, 100% NF 31.25 18.75 No rationale was provided forquantity change relative tocurrent value. Maintainingcurrent value.$-0.04SL195 kit, FISHparaffinpretreatmentNF 1.4 0.75 Maintain consistency in unitof the kit between base codeand add-on code. Seepreamble.$-13.55SL196 kit, HER-2/neuDNA ProbeNF 2.4 1 A single kit is required for thisprocedure which involves asingle specimen with onestain.$-147.00SL248 ethanol, 95% NF 31.25 18.75 No rationale was provided forquantity change relative tocurrent value. Maintainingcurrent value.$-0.0488377M/phmtrc alysishquant/semiqEP110 Freezer NF 1 0 Indirect Practice Expense. Notindividually allocable to aparticular patient for aparticular service$-0.02EP116 VP-2000ProcessorNF 30 0 We are unable to reconcile thenew equipment item with theincreased technician time. Seepreamble.$-2.90CMS-1612-FC 421HCPCSCodeHCPCS CodeDescriptionInputCodeInput CodeDescriptionNF/F/ POLabor Activity(where applicable)RUCRecommendation orcurrent value(min or qty)CMSRefinement(min orqty)CommentDirectCostsChangeL037B HistotechnologistNF SignalEnumeration:Count signals inmalignant cellsand generate datafor pathologist tointerpret24 18 Refined clinical labor time forthis multiplex procedure toreflect efficiencies inexamining two stains on asingle slide.$-2.22SL184 slide, negativecontrol, Her-2NF 0.5 0.2 Maintain consistency in unitof control slides within familyof codes. See preamble.$-8.82SL185 slide, positivecontrol, Her-2NF 0.5 0.2 Maintain consistency in unitof control slides within familyof codes. See preamble.$-8.82SL189 ethanol, 100% NF 37.5 18.75 No rationale was provided forquantity change relative tocurrent value. Maintainingcurrent value.$-0.06SL190 ethanol, 70% NF 12.5 6.25 No rationale was provided forquantity change relative tocurrent value. Maintainingcurrent value.$-0.02SL191 ethanol, 85% NF 12.5 6.25 No rationale was provided forquantity change relative tocurrent value. Maintainingcurrent value.$-0.02SL195 kit, FISHparaffinpretreatmentNF 2 1 Maintain consistency in unitof the kit between base codeand add-on code. Seepreamble.$-20.85SL196 kit, HER-2/neuDNA ProbeNF 3 1 A single kit is required for thisprocedure which involves asingle specimen with onestain.$-210.00SL248 ethanol, 95% NF 37.5 18.75 No rationale was provided forquantity change relative to$-0.06CMS-1612-FC 422HCPCSCodeHCPCS CodeDescriptionInputCodeInput CodeDescriptionNF/F/ POLabor Activity(where applicable)RUCRecommendation orcurrent value(min or qty)CMSRefinement(min orqty)CommentDirectCostsChangecurrent value. Maintainingcurrent value.88380MicrodissectionlaserEP087 instrument,microdissection(Veritas)NF 34 32 Since physician is doing thistask, equipment time wascalculated by summingphysician intraservice time,time to set up machine, andtime to clean machine.$-1.36L045A Cytotechnologist NF Dispose of razorblade, Cap tubeand vortexspecimens.Visually inspecttube to make suremicrodissectedmaterial are at thebottom of tube.3 0 Included in clinical labor task"clean room, equipment, andsupplies"$-1.35L045A Cytotechnologist NF Turn on dissectingmicroscope, placeslide on scope,remove razorblade from box.Microdissecttissue withinetched area, whileviewing slideunder dissectingscope, place tissueinto cap ofcollection tubewith blade.Repeat18 0 Work vignette indicates thatthe microdissection isperformed by the pathologist$-8.1088381MicrodissectionmanualSL085 label formicroscopeNF 4 9 9 slides is typical; 9 labels arerequired$+0.15CMS-1612-FC 423HCPCSCodeHCPCS CodeDescriptionInputCodeInput CodeDescriptionNF/F/ POLabor Activity(where applicable)RUCRecommendation orcurrent value(min or qty)CMSRefinement(min orqty)CommentDirectCostsChangeslides93312EchotransesophagealED021 computer,desktop, wmonitorNF 91 0 Duplicative; item is invascular ultrasound room(EL016)$-0.90ED034 video SVHSVCR (medicalgrade)NF 43 0 Duplicative; item is invascular ultrasound room(EL016)$-0.21ED036 video printer,color (Sonymedical grade)NF 57 0 Duplicative; item is invascular ultrasound room(EL016)$-0.61EF027 table, instrument,mobileNF 105 92 Standard equipment and timefor moderate sedation$-0.02EL016 room,ultrasound,vascularNF 57 43 Refined equipment time toconform to establishedpolicies for highly technicalequipment.$-24.75EQ011 ECG, 3-channel(with SpO2,NIBP, temp,resp)NF 105 92 Standard equipment and timefor moderate sedation$-0.18EQ032 IV infusionpumpNF 0 92 Standard equipment and timefor moderate sedation$0.58L037D RN/LPN/MTA NF Exam documentsscanned intoPACS. Examcompleted in RISsystem to generatebilling processand to populateimages intoRadiologist workqueue3 1 Standard times for clinicallabor tasks associated withdigital imaging$-0.74CMS-1612-FC 424HCPCSCodeHCPCS CodeDescriptionInputCodeInput CodeDescriptionNF/F/ POLabor Activity(where applicable)RUCRecommendation orcurrent value(min or qty)CMSRefinement(min orqty)CommentDirectCostsChangeL050A CardiacSonographerNF Clean scope 0 10 Time for cleaning probesmoved from activity “cleansurgical instrument package”to “clean scope”. 10 minutesunchanged$5.00L050A CardiacSonographerNF Clean surgicalinstrumentpackage10 0 Time for cleaning probesmoved from activity “cleansurgical instrument package”to “clean scope”. 10 minutesunchanged$-5.00L050A CardiacSonographerNF Process data:measure, record,preliminaryfindings8 0 Standard times for clinicallabor tasks associated withdigital imaging$-4.00L050A CardiacSonographerNF Review imageswith MD0 2 Standard times for clinicallabor tasks associated withdigital imaging$1.00L050A CardiacSonographerNF Technologist QCsimages in PACS,checking allimages, reformats,and dose page5 2 Standard times for clinicallabor tasks associated withdigital imaging$-1.50SB026 gown, patient NF 1 0 Duplicative; items areincluded in pack, minimummulti-specialty visit (SA048)$-0.53SB036 paper, examtableNF 7 0 Duplicative; items areincluded in pack, minimummulti-specialty visit (SA048)$-0.10SB037 pillow case NF 1 0 Duplicative; items areincluded in pack, minimummulti-specialty visit (SA048)$-0.3193314EchotransesophagealED021 computer,desktop, w-monitorNF 61 0 Duplicative; item is invascular ultrasound room(EL016)$-0.60CMS-1612-FC 425HCPCSCodeHCPCS CodeDescriptionInputCodeInput CodeDescriptionNF/F/ POLabor Activity(where applicable)RUCRecommendation orcurrent value(min or qty)CMSRefinement(min orqty)CommentDirectCostsChangeED034 video SVHSVCR (medicalgrade)NF 53 0 Duplicative; item is invascular ultrasound room(EL016)$-0.26ED036 video printer,color (Sonymedical grade)NF 67 0 Duplicative; item is invascular ultrasound room(EL016)$-0.71EF027 table, instrument,mobileNF 115 92 Standard equipment and timefor moderate sedation$-0.03EL016 room,ultrasound,vascularNF 67 43 Refined equipment time toconform to changes in clinicallabor time; See preamble.$-42.42EQ011 ECG, 3-channel(with SpO2,NIBP, temp,resp)NF 115 92 Standard equipment and timefor moderate sedation$-0.32EQ032 IV infusionpumpNF 0 92 Standard equipment and timefor moderate sedation$0.58L037D RN/LPN/MTA NF Exam documentsscanned intoPACS. Examcompleted in RISsystem to generatebilling processand to populateimages intoRadiologist workqueue3 1 Standard times for clinicallabor tasks associated withdigital imaging$-0.74L050A CardiacSonographerNF Assist physicianin performingprocedure(acquireultrasound data)40 30 CPT code 93314 is a lessinvolved service than CPTcode 93312, clinical labor timewould not be higher. Seepreamble.$-5.00CMS-1612-FC 426HCPCSCodeHCPCS CodeDescriptionInputCodeInput CodeDescriptionNF/F/ POLabor Activity(where applicable)RUCRecommendation orcurrent value(min or qty)CMSRefinement(min orqty)CommentDirectCostsChangeL050A CardiacSonographerNF Clean scope 0 10 Time for cleaning probesmoved from activity “cleansurgical instrument package”to “clean scope”. 10 minutesunchanged$5.00L050A CardiacSonographerNF Clean surgicalinstrumentpackage10 0 Time for cleaning probesmoved from activity “cleansurgical instrument package”to “clean scope”. 10 minutesunchanged$-5.00L050A CardiacSonographerNF Process data:measure, record,preliminaryfindings8 0 Standard times for clinicallabor tasks associated withdigital imaging$-4.00L050A CardiacSonographerNF Review imageswith MD0 2 Standard times for clinicallabor tasks associated withdigital imaging$1.00L050A CardiacSonographerNF Technologist QCsimages in PACS,checking allimages, reformats,and dose page5 2 Standard times for clinicallabor tasks associated withdigital imaging$-1.50L051A RN NF Assistphysician/moderate sedation (% ofphysician time)40 30 CPT code 93314 is a lessinvolved service than CPTcode 93312, clinical labor timewould not be higher. Seepreamble.$-5.10SB026 gown, patient NF 1 0 Duplicative; items areincluded in pack, minimummulti-specialty visit (SA048)$-0.53SB036 paper, examtableNF 7 0 Duplicative; items areincluded in pack, minimummulti-specialty visit (SA048)$-0.10CMS-1612-FC 427HCPCSCodeHCPCS CodeDescriptionInputCodeInput CodeDescriptionNF/F/ POLabor Activity(where applicable)RUCRecommendation orcurrent value(min or qty)CMSRefinement(min orqty)CommentDirectCostsChangeSB037 pillow case NF 1 0 Duplicative; items areincluded in pack, minimummulti-specialty visit (SA048)$-0.3193320Doppler echoexam heartED021 computer,desktop, w-monitorNF 5 0 Duplicative; item is invascular ultrasound room(EL016)$-0.0593321Doppler echoexam heartED021 computer,desktop, w-monitorNF 2 0 Duplicative; item is invascular ultrasound room(EL016)$-0.0293325Doppler colorflow add-onED021 computer,desktop, w-monitorNF 2 0 Duplicative; item is invascular ultrasound room(EL016)$-0.0293702Bis xtracellfluid analysisL037D RN/LPN/MTA NF Results areuploaded from thedevice into theanalysis softwareand a report isgenerated andprinted forphysician review.2 0 Included as an automaticprocess for the new device.$-0.7493880Extracranialbilat studyED036 video printer,color (Sonymedical grade)NF 10 0 Duplicative; item is invascular ultrasound room(EL016)$-0.11L054A VascularTechnologistNF QADocumentation4 0 Included in overall clinicallabor time; see preamble text$-2.16CMS-1612-FC 428HCPCSCodeHCPCS CodeDescriptionInputCodeInput CodeDescriptionNF/F/ POLabor Activity(where applicable)RUCRecommendation orcurrent value(min or qty)CMSRefinement(min orqty)CommentDirectCostsChangeL054A VascularTechnologistNF Technologistreviews &optimizes allduplex images;reviews &optimizesspectrum analysismeasuringvelocities &assuring properangle acquisition.Compiles findingswith sufficientdata for physicianreview &diagnosis.8 2 Standard times for clinicallabor tasks associated withdigital imaging$-3.2493882Extracranialuni/ltd studyED021 computer,desktop, wmonitorNF 4 0 Duplicative; item is invascular ultrasound room(EL016)$-0.04ED036 video printer,color (Sonymedical grade)NF 10 0 Duplicative; item is invascular ultrasound room(EL016)$-0.11L054A VascularTechnologistNF QADocumentation4 0 Included in overall clinicallabor time; see preamble text$-2.16L054A VascularTechnologistNF Technologist QCsimages in PACS,checking allimages, reformats,and dose page5 2 Standard times for clinicallabor tasks associated withdigital imaging$-1.6293886Intracranialcomplete studyED021 computer,desktop, w-monitorNF 7 0 Duplicative; item is invascular ultrasound room(EL016)$-0.07CMS-1612-FC 429HCPCSCodeHCPCS CodeDescriptionInputCodeInput CodeDescriptionNF/F/ POLabor Activity(where applicable)RUCRecommendation orcurrent value(min or qty)CMSRefinement(min orqty)CommentDirectCostsChangeED036 video printer,color (Sonymedical grade)NF 10 0 Duplicative; item is invascular ultrasound room(EL016)$-0.11L054A VascularTechnologistNF QADocumentation4 0 Included in overall clinicallabor time; see preamble text$-2.16L054A VascularTechnologistNF Technologist QCsimages in PACS,checking allimages, reformats,and dose page8 2 Standard times for clinicallabor tasks associated withdigital imaging$-3.2493888Intracraniallimited studyED021 computer,desktop, wmonitorNF 4 0 Duplicative; item is invascular ultrasound room(EL016)$-0.04ED036 video printer,color (Sonymedical grade)NF 10 0 Duplicative; item is invascular ultrasound room(EL016)$-0.11L054A VascularTechnologistNF QADocumentation4 0 Included in overall clinicallabor time; see preamble text$-2.16L054A VascularTechnologistNF Technologist QCsimages in PACS,checking allimages, reformats,and dose page4 2 Standard times for clinicallabor tasks associated withdigital imaging$-1.0893925Lowerextremity studyED021 computer,desktop, wmonitorNF 7 0 Duplicative; item is invascular ultrasound room(EL016)$-0.07ED036 video printer,color (Sonymedical grade)NF 10 0 Duplicative; item is invascular ultrasound room(EL016)$-0.11ED036 video printer,color (Sonymedical grade)NF 10 0 Duplicative; item is invascular ultrasound room(EL016)$-0.11CMS-1612-FC 430HCPCSCodeHCPCS CodeDescriptionInputCodeInput CodeDescriptionNF/F/ POLabor Activity(where applicable)RUCRecommendation orcurrent value(min or qty)CMSRefinement(min orqty)CommentDirectCostsChangeL054A VascularTechnologistNF QADocumentation4 0 Included in overall clinicallabor time; see preamble text$-2.16L054A VascularTechnologistNF Technologistreviews &optimizes allduplex images;reviews &optimizesspectrum analysismeasuringvelocities &assuring properangle acquisition.Compiles findingswith sufficientdata for physicianreview &diagnosis.8 2 Standard times for clinicallabor tasks associated withdigital imaging$-3.2493926Lowerextremity studyED021 computer,desktop, wmonitorNF 4 0 Duplicative; item is invascular ultrasound room(EL016)$-0.04ED036 video printer,color (Sonymedical grade)NF 10 0 Duplicative; item is invascular ultrasound room(EL016)$-0.11L054A VascularTechnologistNF QADocumentation4 0 Included in overall clinicallabor time; see preamble text$-2.16CMS-1612-FC 431HCPCSCodeHCPCS CodeDescriptionInputCodeInput CodeDescriptionNF/F/ POLabor Activity(where applicable)RUCRecommendation orcurrent value(min or qty)CMSRefinement(min orqty)CommentDirectCostsChangeL054A VascularTechnologistNF Technologistreviews &optimizes allduplex images;reviews &optimizesspectrum analysismeasuringvelocities &assuring properangle acquisition.Compiles findingswith sufficientdata for physicianreview &diagnosis.5 2 Standard times for clinicallabor tasks associated withdigital imaging$-1.6293930Upperextremity studyED021 computer,desktop, wmonitorNF 7 0 Duplicative; item is invascular ultrasound room(EL016)$-0.07ED036 video printer,color (Sonymedical grade)NF 10 0 Duplicative; item is invascular ultrasound room(EL016)$-0.11L054A VascularTechnologistNF QADocumentation4 0 Included in overall clinicallabor time; see preamble text$-2.1693931Upperextremity studyED021 computer,desktop, wmonitorNF 4 0 Duplicative; item is invascular ultrasound room(EL016)$-0.04ED036 video printer,color (Sonymedical grade)NF 10 0 Duplicative; item is invascular ultrasound room(EL016)$-0.11L054A VascularTechnologistNF QADocumentation4 0 Included in overall clinicallabor time; see preamble text$-2.16CMS-1612-FC 432HCPCSCodeHCPCS CodeDescriptionInputCodeInput CodeDescriptionNF/F/ POLabor Activity(where applicable)RUCRecommendation orcurrent value(min or qty)CMSRefinement(min orqty)CommentDirectCostsChange93970 Extremity studyED021 computer,desktop, wmonitorNF 7 0 Duplicative; item is invascular ultrasound room(EL016)$-0.07ED036 video printer,color (Sonymedical grade)NF 10 0 Duplicative; item is invascular ultrasound room(EL016)$-0.11L054A VascularTechnologistNF QADocumentation4 0 Included in overall clinicallabor time; see preamble text$-2.1693971 Extremity studyED021 computer,desktop, wmonitorNF 4 0 Duplicative; item is invascular ultrasound room(EL016)$-0.04ED036 video printer,color (Sonymedical grade)NF 10 0 Duplicative; item is invascular ultrasound room(EL016)$-0.11L054A VascularTechnologistNF QADocumentation4 0 Included in overall clinicallabor time; see preamble text$-2.1693975 Vascular studyED021 computer,desktop, wmonitorNF 7 0 Duplicative; item is invascular ultrasound room(EL016)$-0.07ED036 video printer,color (Sonymedical grade)NF 10 0 Duplicative; item is invascular ultrasound room(EL016)$-0.11L054A VascularTechnologistNF QADocumentation4 0 Included in overall clinicallabor time; see preamble text$-2.16CMS-1612-FC 433HCPCSCodeHCPCS CodeDescriptionInputCodeInput CodeDescriptionNF/F/ POLabor Activity(where applicable)RUCRecommendation orcurrent value(min or qty)CMSRefinement(min orqty)CommentDirectCostsChangeL054A VascularTechnologistNF Technologistreviews &optimizes allduplex images;reviews &optimizesspectrum analysismeasuringvelocities &assuring properangle acquisition.Compiles findingswith sufficientdata for physicianreview &diagnosis.8 2 Standard times for clinicallabor tasks associated withdigital imaging$-3.2493976 Vascular studyED021 computer,desktop, wmonitorNF 4 0 Duplicative; item is invascular ultrasound room(EL016)$-0.04ED036 video printer,color (Sonymedical grade)NF 10 0 Duplicative; item is invascular ultrasound room(EL016)$-0.11L054A VascularTechnologistNF QADocumentation4 0 Included in overall clinicallabor time; see preamble text$-2.16CMS-1612-FC 434HCPCSCodeHCPCS CodeDescriptionInputCodeInput CodeDescriptionNF/F/ POLabor Activity(where applicable)RUCRecommendation orcurrent value(min or qty)CMSRefinement(min orqty)CommentDirectCostsChangeL054A VascularTechnologistNF Technologistreviews &optimizes allduplex images;reviews &optimizesspectrum analysismeasuringvelocities &assuring properangle acquisition.Compiles findingswith sufficientdata for physicianreview &diagnosis.5 2 Standard times for clinicallabor tasks associated withdigital imaging$-1.6293978 Vascular studyED021 computer,desktop, wmonitorNF 7 0 Duplicative; item is invascular ultrasound room(EL016)$-0.07ED021 computer,desktop, wmonitorNF 7 0 Duplicative; item is invascular ultrasound room(EL016)$-0.07ED036 video printer,color (Sonymedical grade)NF 10 0 Duplicative; item is invascular ultrasound room(EL016)$-0.11L054A VascularTechnologistNF QADocumentation4 0 Included in overall clinicallabor time; see preamble text$-2.1693979 Vascular studyED021 computer,desktop, wmonitorNF 4 0 Duplicative; item is invascular ultrasound room(EL016)$-0.04ED036 video printer,color (Sonymedical grade)NF 10 0 Duplicative; item is invascular ultrasound room(EL016)$-0.11CMS-1612-FC 435HCPCSCodeHCPCS CodeDescriptionInputCodeInput CodeDescriptionNF/F/ POLabor Activity(where applicable)RUCRecommendation orcurrent value(min or qty)CMSRefinement(min orqty)CommentDirectCostsChangeL054A VascularTechnologistNF QADocumentation4 0 Included in overall clinicallabor time; see preamble text$-2.1693990Doppler flowtestingED021 computer,desktop, wmonitorNF 4 0 Duplicative; item is invascular ultrasound room(EL016)$-0.04ED036 video printer,color (Sonymedical grade)NF 4 0 Duplicative; item is invascular ultrasound room(EL016)$-0.04L054A VascularTechnologistNF QADocumentation4 0 Included in overall clinicallabor time; see preamble text$-2.1695971AnalyzeneurostimsimpleEF023 table, exam NF 27 33 Include 100% of intraservicetime for equipment even whenclinical labor assist time is66% of physician time.$0.02EQ209 programmer,neurostimulator(w-printer)NF 27 33 Include 100% of intraservicetime for equipment even whenclinical labor assist time is66% of physician time.$0.0495972AnalyzeneurostimcomplexEF023 table, exam NF 30 36 Include 100% of intraservicetime for equipment even whenclinical labor assist time is66% of physician time.$0.02EQ209 programmer,neurostimulator(w-printer)NF 30 36 Include 100% of intraservicetime for equipment even whenclinical labor time is 66% ofassist physician time.$0.0496127Briefemotional/behav assmtL026A Medical/Technical AssistantNF Scoringcompletedbehaviorassessment tool15 7 Instructions suggest that ittypically takes 7 minutes forscoring the tests included asstandardized tests for thisprocedure.$-2.0897605Neg presswound tx </=50EF014 light, surgical NF 28 25 Refined equipment time toconform to changes in clinical$-0.03CMS-1612-FC 436HCPCSCodeHCPCS CodeDescriptionInputCodeInput CodeDescriptionNF/F/ POLabor Activity(where applicable)RUCRecommendation orcurrent value(min or qty)CMSRefinement(min orqty)CommentDirectCostsChangecmlabor time.EF031 table, power NF 28 25 Refined equipment time toconform to changes in clinicallabor time.$-0.05L037D RN/LPN/MTA NF Check dressings& wound/ homecare instructions/coordinate officevisits/prescriptions5 2 Intraservice clinical labor timealso includes time for woundchecking$-1.1197606Neg presswound tx >50cmEF014 light, surgical NF 38 35 Refined equipment time toconform to changes in clinicallabor time.$-0.03EF031 table, power NF 38 35 Refined equipment time toconform to changes in clinicallabor time.$-0.05L037D RN/LPN/MTA NF Check dressings& wound/ homecare instructions/coordinate officevisits/prescriptions5 2 Intraservice clinical labor timealso includes time for woundchecking$-1.11EF031 table, power NF 38 35 Refined equipment time toconform to changes in clinicallabor time.$-0.05L037D RN/LPN/MTA NF Check dressings& wound/ homecare instructions/coordinate officevisits/prescriptions5 2 Intraservice clinical labor timealso includes time for woundchecking$-1.11CMS-1612-FC 437HCPCSCodeHCPCS CodeDescriptionInputCodeInput CodeDescriptionNF/F/ POLabor Activity(where applicable)RUCRecommendation orcurrent value(min or qty)CMSRefinement(min orqty)CommentDirectCostsChange99490Chron caremgmt srvc 20minChron caremgmt srvc 20minL051A RN NF Care managementactivitiesperformed byclinical staff60 0 20 minutes RN/LPN/MTAtime reflects the typicalservice; see CCM preamble.$-30.60L037D RN/LPN/MTA NF Care managementactivitiesperformed byclinical staff0 20 20 minutes RN/LPN/MTAtime reflects the typicalservice; see CCM preamble.$7.40CMS-1612-FC 438

iii. Procedures Subject to the Cap on Imaging Codes Defined by Section 5102(b) of the DRA We are proposing to add the new codes to the list of procedures s ubject to the DRA cap, effective January 1, 2015. The codes ar e: (76641 (Ultrasound breast complete), 76642 (Ultrasound breast limited), 77085 (Dxa bone dens ity study), 77086 (Fracture assessment via dxa), 77387 (Guidance for radiaj tx dlvr), G 6001 (Stereoscopic x-ra y guidance), and G6002 (Echo guidance radiotherapy). These codes, wh ich are new for CY 2015, replace codes deleted for CY 2015 that were subject to the cap, and meet the definition of imaging under section 5102(b) of the DRA. These code s are being added on an interim final basis and are open to public comment in this final rule with comment period. d. Establishing CY 2015 Interim Final Malpractice RVUs According to our malpractice methodology disc ussed in section II.C, we are assigning malpractice RVUs for CY 2015 new, revised, an d potentially misvalued codes by utilizing a

crosswalk to a source code with a similar ma lpractice risk. We have reviewed the RUC recommended malpractice source code crosswal ks for CY 2015 new, revised, and potentially misvalued codes, and we are accepting all of th em on an interim final basis for CY 2015. For Gcodes that we are creating, we are also assigning source code crosswalks to similar codes.

Table 32 lists the CY 2015 HCPCS codes and th eir respective source codes used to set

the interim final CY 2015 MP RVUs. The MP RVUs for these services are reflected in

Addendum B of this CY 2015 PFS fina l rule with comment period. TABLE 32: Crosswalk for Establishing CY 2015 New/Revised/Po tentially Misvalued Codes Malpractice RVUs CY 2015 New, Revised or Misvalued Code Malpractice Risk Factor Crosswalk Code 20604 Drain/inj joint/bursa w/us 20600 Drain/inject joint/bursa 20606 Drain/inj joint/bursa w/us 20605 Drain/inject joint/bursa 20611 Drain/inj joint/bursa w/us 20610 Drain/inject joint/bursa 20983 Ablate bone tumor(s) perq 20982 Ablate bone tumor(s) perq 21811 Optx of rib fx w/fixj scope 21805 Treatment of rib fractureCMS-1612-FC 439

CY 2015 New, Revised or Misvalued Code Malpractice Risk Factor Crosswalk Code 21812 Treatment of rib fracture 21805 Treatment of rib fracture 21813 Treatment of rib fracture 21805 Treatment of rib fracture 22510 Perq cervicothoracic inject 22520 Percut vertebroplasty thor 22511 Perq lumbosacral injection 22521 Percut vertebroplasty lumb 22512 Vertebroplasty addl inject 22522 Percut vertebroplasty addl 22513 Perq vertebral augmentation 22523 Percut kyphoplasty thor 22514 Perq vertebral augmentation 22524 Percut kyphoplasty lumbar 22515 Perq vertebral augmentation 22525 Percut kyphoplasty add-on 22858 Second level cer diskectomy 22856 Cerv artific diskectomy 27279 Arthrodesis sacroiliac joint 62287 Percutaneous diskectomy 33270 Ins/rep subq defibrillator 33249 Nsert pace-defib w/lead 33271 Insj subq impltbl dfb elctrd 33216 Insert 1 electrode pm-defib 33272 Rmvl of subq defibrillator 33244 Remove eltrd transven 33273 Repos prev impltbl subq dfb 33215 Reposition pacing-defib lead 33418 Repair tcat mitral valve 92987 Revision of mitral valve 33419 Repair tcat mitral valve 92987 Revision of mitral valve 33946 Ecmo/ecls initiation venous 33960 External circulation assist 33947 Ecmo/ecls initiation artery 33960 External circulation assist 33948 Ecmo/ecls daily mgmt-venous 33961 External circulation assist 33949 Ecmo/ecls daily mgmt artery 33961 External circulation assist 33951 Ecmo/ecls insj prph cannula 36822 Insertion of cannula(s) 33952 Ecmo/ecls insj prph cannula 36822 Insertion of cannula(s) 33953 Ecmo/ecls insj prph cannula 36822 Insertion of cannula(s) 33954 Ecmo/ecls insj prph cannula 36822 Insertion of cannula(s) 33955 Ecmo/ecls insj ctr cannula 33981 Replace vad pump ext 33956 Ecmo/ecls insj ctr cannula 33981 Replace vad pump ext 33957 Ecmo/ecls repos perph cnula 33981 Replace vad pump ext 33958 Ecmo/ecls repos perph cnula 33981 Replace vad pump ext 33959 Ecmo/ecls repos perph cnula 33981 Replace vad pump ext 33962 Ecmo/ecls repos perph cnula 33981 Replace vad pump ext 33963 Ecmo/ecls repos perph cnula 33981 Replace vad pump ext 33964 Ecmo/ecls repos perph cnula 33981 Replace vad pump ext 33965 Ecmo/ecls rmvl perph cannula 33981 Replace vad pump ext 33966 Ecmo/ecls rmvl prph cannula 33981 Replace vad pump ext 33969 Ecmo/ecls rmvl perph cannula 33971 Aortic circulation assist 33984 Ecmo/ecls rmvl prph cannula 33971 Aortic circulation assist 33985 Ecmo/ecls rmvl ctr cannula 33977 Remove ventricular device 33986 Ecmo/ecls rmvl ctr cannula 33977 Remove ventricular device 33987 Artery expos/graft artery 33530 Coronary artery bypass/reop 33988 Insertion of left heart vent 33530 Coronary artery bypass/reop 33989 Removal of left heart vent 33257 Ablate atria lmtd add-on 37218 Stent placemt ante carotid 37217 Stent placemt retro carotid 43180 Esophagoscopy rigid trnso 43130 Removal of esophagus pouch 44381 Small bowel endoscopy br/wa 45340 Sig w/balloon dilation 44384 Small bowel endoscopy 44383 Ileoscopy w/stent 45346 Sigmoidoscopy w/ablation 45339 Sigmoidoscopy w/ablate tumr 45347 Sigmoidoscopy w/plcmt stent 45345 Sigmoidoscopy w/stent 45349 Sigmoidoscopy w/resection 43236 Uppr gi scope w/submuc injCMS-1612-FC 440

CY 2015 New, Revised or Misvalued Code Malpractice Risk Factor Crosswalk Code 45350 Sgmdsc w/band ligation 45332 Sigmoidoscopy w/fb removal 45388 Colonoscopy w/ablation 45383 Lesion removal colonoscopy 45389 Colonoscopy w/stent plcmt 45387 Colonoscopy w/stent 45390 Colonoscopy w/resection 45385 Lesion removal colonoscopy 45393 Colonoscopy w/decompression 45379 Colonoscopy w/fb removal 45398 Colonoscopy w/band ligation 45379 Colonoscopy w/fb removal 47383 Perq abltj lvr cryoablation 47382 Percut ablate liver rf 52441 Cystourethro w/implant 52282 Cystoscopy implant stent 52442 Cystourethro w/addl implant 52282 Cystoscopy implant stent 62302 Myelography lumbar injection 62284 Injection for myelogram 62303 Myelography lumbar injection 62284 Injection for myelogram 62304 Myelography lumbar injection 62284 Injection for myelogram 62305 Myelography lumbar injection 62284 Injection for myelogram 64486 Tap block unil by injection 64447 N block inj fem single 64487 Tap block uni by infusion 64448 N block inj fem cont inf 64488 Tap block bi injection 64447 N block inj fem single 64489 Tap block bi by infusion 64448 N block inj fem cont inf 66179 Aqueous shunt eye w/o graft 66180 Implant eye shunt 66184 Revision of aqueous shunt 66185 Revise eye shunt 76641 Ultrasound breast complete 76645 Us exam breast(s) 76642 Ultrasound breast limited 76645 Us exam breast(s) 77063 Breast tomosynthesis bi 77057 Mammogram screening 77085 Dxa bone density study 77080 Dxa bone density axial 77086 Fracture assessment via dxa 77082 Dxa bone density vert fx 77306 Telethx isodose plan simple 77305 Teletx isodose plan simple 77307 Telethx isodose plan cplx 77315 Teletx isodose plan complex 77316 Brachytx isodose plan simple 77326 Brachytx isodose calc simp 77317 Brachytx isodose intermed 77327 Brachytx isodose calc interm 77318 Brachytx isodose complex 77328 Brachytx isodose plan compl 88341 Immunohisto antibody slide 88342 Immunohisto antibody slide 88344 Immunohisto antibody slide 88342 Immunohisto antibody slide 88364 Insitu hybridization (fish) 88365 Insitu hybridization (fish) 88366 Insitu hybridization (fish) 88365 Insitu hybridization (fish) 88369 M/phmtrc alysishquant/semiq 88368 Insitu hybridization manual 88373 M/phmtrc alys ishquant/semiq 88367 Insitu hybridization auto 88374 M/phmtrc alys ishquant/semiq 88367 Insitu hybridization auto 88377 M/phmtrc alys ishquant/semiq 88368 Insitu hybridization manual 91200 Liver elastography 91132 Electrogastrography 92145 Corneal hysteresis deter 76514 Echo exam of eye thickness 93260 Prgrmg dev eval impltbl sys 93282 Icd device progr eval 1 sngl 93261 Interrogate subq defib 93289 Icd device interrogate 93355 Echo transesophageal (tee) 93312 Echo transesophageal 93644 Electrophysiology evaluation 93642 Electrophysiology evaluation 93702 Bis xtracell fluid analysis 93701 Bioimpedance cv analysis 93895 Carotid intima atheroma eval 93882 Extracranial uni/ltd study 96127 Brief emotional/behav assmt 96110 Developmental screen 99184 Hypothermia ill neonate 99291 Critical care first hour 99490 Chron care mgmt srvc 20 min 99212 Office/outpatient visit estCMS-1612-FC 441

CY 2015 New, Revised or Misvalued Code Malpractice Risk Factor Crosswalk Code G0277 Hbot, full body chamber, 30m 99183 Hyperbaric oxygen therapy G0279 tomosynthesis, mamo scre 77055 Mammogram one breast G0473 Face-to-face behavioral counseling for obesity, group (2-10), 30 minutes G0477 Behavior counsel obesity 15mCMS-1612-FC 442

H. Chronic Care Management (CCM)

As we discussed in the CY 2013 PFS final rule with comment period, we are committed to supporting primary care and we have increasin gly recognized care management as one of the critical components of primary care that contribu tes to better health for individuals and reduced expenditure growth (77 FR 68978) . Accordingly, we have prioritized the development and implementation of a series of initiatives desi gned to improve payment for, and encourage longterm investment in, care management 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 Orga nizations; Final Rule,’’ which appeared in the November 2, 2011 Federal Register (76 FR 67802)).

● The testing of the Pion eer ACO model, designed fo r experienced health care organizations (described on the Centers for Medicare and Medicaid Innovation’s (Innovation Center’s) website at http://innovation.cms .gov/initiatives/Pioneer-ACO-Model/index.html).

● The testing of the Advance Payment AC O model, designed to support organizations participating in the Medicare Shared Savings Program (described on the Innovation Center’s website at http://innovation.cms.gov/initia tives/Advance-Paym ent-ACO-Model/).

● The Primary Care Incentive Payment (PCI P) Program (described on the CMS websiteat www.cms.gov/Medicare/Medicare-Fee-for-ServicePayment/PhysicianFeeSched/Downl oads/PCIP-2011-Payments.pdf).

● The patient-centered medical home model in the Multi-payer Advanced Primary Care Practice (MAPCP) Demonstration de signed to test whether the quali ty and coordination of health care services are improved by making advanced primary care practices more broadly availableCMS-1612-FC 443

(described on the CMS website at www.cms.gov/Medicare/DemonstrationProjects/DemoProjectsEvalRpts/dow nloads/mapcpdemo_Factsheet.pdf).

● The Federally Qualified Health Center (FQHC) Advanced Primary Care Practice demonstration (described on the CMS website at http://www.cms.gov/Medicare/DemonstrationProjects/DemoProjectsEvalRpts/Download s/FQHC_APCP_Demo_FAQsOct2011.pdf and the

Innovation Center’s website at www.innovatio ns.cms.gov/initiatives/FQHCs/index.html).

● The Comprehensive Primary Care (CPC ) initiative (described on the Innovation Center’s website at http://innovations.cms .gov/initiatives/Compreh ensive-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 certain markets across the country. In addition, HHS leads a broad initiative focused on optimizing health and quality of life for individuals with multiple chronic conditi ons. HHS’s Strategic Framework on Multiple Chronic Conditions outlines spec ific objectives and strategies for HHS and private sector partners centered on strengtheni ng the health care and public h ealth systems; empowering the

individual to use self -care management with the assistance of a heal thcare provider who can assess the patient’s health liter acy level; equipping care providers with tools, information, and other interventions; and supporting targeted res earch about individuals with multiple chronic

conditions and effective interventi ons. Further information on this initiative is available on the HHS website at http://www.hhs.gov/as h/initiatives/mcc/index.html. In coordination with all of these initiatives, we also have continued to explore potential refinements to the PFS that would appropriately value care management within Medicare’s statutory structure for fee-for-s ervice physician payment and quality reporting. For example, inCMS-1612-FC 444

the CY 2013 PFS final rule with comment period, we adopted a policy to pay separately for care management involving the transiti on of a beneficiary from care furnished by a treating physician during a hospital stay to care furnished by the be neficiary’s primary physic ian in the community (77 FR 68978 through 68993).

In the CY 2014 PFS final rule with comment period, we finalized a policy to pay separately for care management services furnishe d to Medicare beneficiaries with two or more chronic conditions beginning in CY 2015 (78 FR 74414).

1. Valuation of CCM Services

− GXXX1 CCM is a unique PFS service designed to pa y separately for n on-face-to-face care coordination services furnished to Medicare beneficiaries with multiple chronic conditions. (See 78 FR 74414 for a more thorough discussion of the beneficiaries for whom this service may be billed and the scope of service elements.) In the CY 2014 PFS final ru le with comment period, we indicated that, to recognize the additional resources required to furnish CCM services to patients with multiple chronic conditions, we were creating the following code to use for reporting this service (78 FR 74422):

● GXXX1 Chronic care management services fu rnished to patients with multiple (two or more) chronic conditions expected to last at least 12 months, or until the d eath of the patient, that place the patient at significant risk of death, acute exacerbatio n/decompensation, or functional decline; 20 minutes or more; per 30 days. Although this service is unique in that it was created to separately pay for care management services, other code s include care management co mponents. To value CCM, we compared it to other codes that involve care ma nagement. In doing so, we concluded that the CCM services were similar in work (time and in tensity) to that of the non-face-to-face portion ofCMS-1612-FC 445

the lower level code for transitional care management (TCM) services (CPT code 99495 (Transitional Care Management Services with the following required el ements: Communication (direct contact, telephone, electroni c) with the patient and/or care giver within 2 business days of discharge Medical decision making of at least moderate comple xity during the service period face-to-face visit, within 14 cale ndar days of discharge)). A ccordingly, we based the proposed inputs on the non-face-to-face por tion of CPT code 99495. Specifically, we proposed a work RVU for GX XX1 of 0.61, which is the portion of the

work RVU for CPT code 99495 that remains after s ubtracting the work attr ibutable to the faceto-face visit. (CPT code 99214 (Office/outpatient visit est) was used to value CPT code 99495, which has a work RVU of 1.50). Similarly, we proposed a work time of 15 minutes for HCPCS

code GXXX1 for CY 2015 based on the time attri butable to the non-face -to-face portion of CPT

99495. For direct PE inputs, we proposed 20 minutes of clinical labor time. As established in the

CY 2014 PFS final rule with commen t period, in order to bill for th is code, at least 20 minutes of CCM services must be furnished during the 30 -day billing interval (78 FR 74422). Based upon input from stakeholders and the nature of car e management services, we believed that many aspects of this service will be provided by clinical staff, and thus, clinical staff would be involved in the typical service for the full 20 minutes. CPT code 99495 has 45 minutes of nonface-to-face clinical labor time and we assume d the typical case for CCM would involve 20 minutes based upon the code descriptor and a br oad eligible populati on that would require limited monthly services. The proposed CY 2015 dire ct PE input database reflected the input of

20 minutes of clinical labor time and is availa ble on the CMS website under the supporting data files for the CY 2015 PFS proposed rule at http://www.cms.gov/Medi care/Medicare-Fee-for-CMS-1612-FC 446

Service-Payment/PhysicianFeeSched/PFS-Federal-Regulation-Notices.html. The resulting proposed PE RVUs were 0.57 for CCM furnishe d in non-facility locations and 0.26 for CCM furnished in a facility. The proposed MP RVU of 0.04 was calculated us ing the weighted risk factors for the specialties that we believed would furnish this service. We believed the proposed malpractice risk factor would appropriately reflect the relative malpractice risk associated with furnishing

CCM services. We received many public comments on our pr oposed valuation. In general, the commenters commended CMS for ongoing recogniti on of the value of non-face-to-face time expended by physicians and staff to improve outcomes for benefici aries with chronic conditions, and the proposal to pay separately for the non-fa ce-to-face services. However, the commenters generally believed the proposed valuation for CCM services u nderestimated the resources involved with complex beneficiaries, and reco mmended various alternatives for valuing the services. We summarize these comments in the following paragraphs.

Comment: Several commenters noted that th e CPT Editorial Panel created a new code for CY 2015 that is extremely similar to the G-co de we developed to report these services. These commenters suggested that we use th e new CPT code 99490 (Chronic care management services, at least 20 minutes of clinical staff tim e directed by a physician or other qualified health care professional, per calendar month, w ith the following required elements:

• Multiple (two or more) chronic conditions expect ed to last at least 12 months, or until the death of the patient;

• Chronic conditions place the patient at significant risk of death, acute exacerbation/decompensation, or functional decline;CMS-1612-FC 447

• Comprehensive care plan es tablished, implemented, revised, or monitored). Many of these commenters expressed a prefer ence for the “per calendar month” used in the CPT descriptor to the “per 30 days” used in the G-code. The co mmenters said a calendar month rather than 30 days would be less complex administratively. Response: It is our preference to use CP T codes unless Medicare has a programmatic need that is not met by the CPT coding structure. Accordingly, in the CY 2014 final rule with comment period we indicated that we would consid er using a CPT code if one was created that reflected the service we were describing with th e G-code. We believe that the new CPT code 99490 appropriately describes CCM servic es for Medicare beneficiaries. We had used 30 days rather than a calendar mo nth as the service period for the G-code so that the number of days in the service peri od would not vary based upon when CCM services were initiated for a given period. For example, if the services were ini tiated near the end of a calendar month, using the CPT code’s period of “p er calendar month” would make it harder for the practitioner to meet the required minimum tim e for the month and be able to bill CMM for

that month. However, after learning about the administra tive difficulties that the 30-day period would create, we believe that the calendar month creat es a reasonable period. Accordingly, we will adopt CPT code 99490 for Medicare CCM services , effective January 1, 2015 instead of the

G code. Comment: Several commenters suggested altern ative approaches to the use of codes that describe CCM services. For example, one commen ter said that the code should be for one year, with average of 20 minutes per month across the year. Another commenter was concerned about how the 20 minutes of care per month per patient will be calculated, because some patientsCMS-1612-FC 448

(those whose condition is less well controlled) w ill demand more attention and care than average patients, while those whose conditi on is well controlled might require very little attention. This commenter suggested that a reas onable solution would be for the care minutes per patient per month to be calculated as an average across a number of CCM patients. The commenter added that for patients entering and exit ing mid-month, the average minutes of care could be calculated on a pro rata basis which adjusts for the partia l months they are eligible for CCM services.

Several other commenters said that CMS s hould use a capitated payment methodology for CCM services in the long run, but supported CCM servi ces using the CPT codes as valued by the RUC as a short-term transitional strategy until CMS is able to expand the per beneficiary per month care management fee under CMS’s primary care de monstration initiatives to all physicians. Others commented similarly that the long-te rm goal is capitated payments like the demonstrations/models that better encourage pop ulation-based health management and reducing

utilization. Several commenters submitted recommendations for valuation based on their experience in CMS’s Patient-Centered Medical Home multipayer initiative. Assuming CCM services are furnished by a care manager receiving an annua l salary of $150,000, and taking into account a commonly accepted patient to care manager ratio of 1:150, these commenters believed that under the proposed payment rate, the average service time possible would be a ceiling of 23 minutes (not a floor of 20 minutes). Ba sed on one tracking study of care manager activity in minutes per patient per month, they believed complex care management would require 42 minutes of face-toface and non-face-to-face time per month. Assumi ng the same care manger salary and patient load, the commenters asserted that the monthl y payment amount necessary to provide this amount of care would be $83 pe r beneficiary per month.CMS-1612-FC 449

Response: Our proposal to pay separately for th ese services is part of a broader series of potential refinements to the PFS that appropriate ly value care management within Medicare’s statutory structure for fee-for-ser vice physician payment. We do not have statutory authority to base payment under the PFS on a recurring per benefi ciary per month basis. The PFS is limited to a fee-for-service model at present, and as su ch we do not use capitated payment for services that may or may not be furnished in a given mont h. We refer the commenter and other interested stakeholders to the preceding paragraphs that de scribe a broader set of initiatives that are designed to improve payment for, and encourag e long-term investment in, care management services, including a variety of CMS a nd HHS programs and demonstrations. Comment: Many commenters recommended a hi gher valuation for CCM services than was proposed, with some commenters providing speci fic suggestions as to changes in inputs and others simply asserting that a hi gher payment was appropriate or necessary to achieve access or

the desired benefit. One commenter recomm ended a payment of $75 but did not provide supporting information. Several other commen ters recommended that CMS adopt the RUCrecommended values for CPT code 99490 (work time of 30 minutes, work RVU of 1.0, and 60 minutes of clinical labor time). Several comm enters believed CMS should adopt the work, PE and MP RVUs for CPT code 99495, with one comme nter suggesting that CMS crosswalk the PE and MP RVU from the TCM code and not just the work RVU from the code in order to equalize payment for the CCM code with a per beneficiar y per month payment that is made for similar services through a state Medicaid program. Another commen ter pointed out that the proposed

combined MP and PE RVU of 0.61 for CCM is si gnificantly lower than for the following similar

services that cannot be b illed during same period with CCM: HCPCS code G0181 (Home Healthcare Oversight) which has a combined MP and PE RVU of 1.28; HCPCS code G0182CMS-1612-FC 450

(Hospice Care Plan Oversight) which has a co mbined MP and PE RVU of 1.30; CPT code 99339 (Care Plan Oversight Services) which has a co mbined MP and PE RVU of 0.94; and CPT code 99358 (Prolonged Services without Direct Patient Contact) which has a combined MP and PE

RVU of 0.98. Several commenters suggested that CMS’ s comparison with TCM, CPT code 99495, was not an appropriate comparison. One commenter asked what codes other than CPT code 99495 CMS considered as similar to CCM for purposes of CCM valuation. Th is commenter believed the time and intensity required for the non-f ace-to-face portion of CPT code 99495 is not the

same as for CCM services. Several commenters suggested that CMS shoul d develop PE RVUs for the service using alternative methodologies than for other PFS servi ces. For example, several commenters stated that CMS should adjust the PE RVUs to account fo r major infrastructure and other costs required for CCM, especially health information tec hnology, computer equipment, 24/7 beneficiary access, extensive documentation, nursing staff a nd other overhead costs. One commenter believed the proposed RVUs accounted for personnel costs but not the practice expense for health information technology, workfo rce retooling, and analytics. We received many public comments on the appr opriate work time and direct PE inputs for clinical staff time. Most suggested that the proposed inputs for time were too low and recommended using the RUC-recommended values (work time of 30 minutes and 60 minutes of clinical labor time). Regarding clinical labor time, some commenters believed the proposed 20

minutes of clinical labor was too low, being the 25 th percentile for work time in the RUC survey, and they noted the significantly higher time re ported in response to the RUC survey of 60

minutes of clinical labor time. Another comm enter said that assuming 20 minutes of serviceCMS-1612-FC 451

time per month as typical significantly undervalue s the service and questioned how CMS arrived at that number. Regarding the work time, several commenters addressed the work RVU, recommending that the proposed RVU be adjusted upwards but did not specify by how much.

Several commenters noted that the RUC r ecommendation of 1.0 work RVU for CPT codes 99490 and 99487 (Cmplx chron care w/o pt visit) is based on median survey work times of 30 minutes and 26 minutes, respectively, for these CCM codes. (The long descriptor for CPT code 99487 is, Complex chronic care management serv ices, with the following required elements:

• Multiple (two or more) chronic conditions expected to last at least 12 months, or until the death of the patient;

• Chronic conditions place the patient at significant risk of death, acute exacerbation/decompensation, or functional decline;

• Establishment or substantial revisi on of a comprehensive care plan;

• Moderate or high complexity medical decision making;

• 60 minutes of clinical staff time directed by a physician or other qualified health care professional, per calendar month). However several commenters did not objec t to the proposed valuation for GXXX1 and recommended that CMS monitor payment adequacy and appropriate valuation once the code is implemented. Response: After considerati on of the various comments on th e work RVUs, we continue to believe that the most appropriate mechanis m for determining the appropriate work RVU for this service is by using the non-face-to-face por tion of the lower level TCM code, CPT code

99495. We continue to believe th at the work and intensity for CCM services furnished to the eligible beneficiaries is comparable to the work and intensity involved in furnishing the non-CMS-1612-FC 452

face-to-face portion of the service described by CPT code 99495. Therefore, we believe that using CPT code 99495 as the comparison code assure s appropriate relativity with other similar services. The services suggested by the commenters as comparable to the CCM code require significantly more time. CPT code 99358 is for an hour of non-face-to-face time and has a work

time of 60 minutes. CPT code 99339 has a work time of 40 minutes and is furnished to a significantly different patient population (those in a domiciliary or rest home). HCPCS codes

G0181 and G0182 have work time of almost 60 minut es and also are furnished to significantly different patient populations. We appreciate commenters’ concerns regardi ng the various kinds of practice expense and malpractice liability costs that practices incu r as they manage beneficiaries requiring CCM services. However, we continue to believe th at our established PE a nd MP methodology used to value the wide ranges of services across the PFS assu res that we have the a ppropriate relativity in our payments. Although many commenters recommended that we use the time from the RUC survey of

60 minutes of clinical labor and 30 minutes of work time, we be lieve that since CCM is a new separately billable service, the survey data may be less reliable as the practitioners would have no experience with the code. Since at least 20 minutes of services ar e required to be furnished in order to report the service and our inform ation, including comments, suggests that many

beneficiaries who meet Medicare ’s criteria for CCM services would not need more than the minimum required minutes of service, we belie ve 60 minutes would overestimate the typical number of clinical labor minutes during one month for the typical e ligible beneficiary. Accordingly, we are finalizing our propos ed work and clinical labor times.

Comment: A number of commenters recommen ded that coinsurance should not apply toCMS-1612-FC 453

CCM services. These commenters were concerne d that the $8 estimated coinsurance amount in the proposed rule would hinder beneficiary access. Several commenters believed that CCM is a preventive service that should be exempt from be neficiary cost sharing. They noted that costsharing will make it challengi ng to reach the 20 minutes re quired for billing, because beneficiaries will delay care until face-to-face is necessary Response: CCM services do not fall into any of the statutor y preventive services benefit categories of the Act. The Secretary has the au thority to add “additional preventive services” that, among other things, have been assigned an “A” or “B” rating by the United States Preventive Services Task Force, but CCM ha s not earned such a rating. Since CCM does not meet the criteria, we cannot designate it as an additional preventiv e service under section 1861(s)(2)(BB) of the Act. Further, we do not have other statutory authority that would allow us to waive the applicable coinsurance for CCM se rvices. As discussed in the CY 2014 PFS final rule with comment period (78 FR 74424), in order to assure that benefici aries are aware of the

coinsurance for this non-face-to -face service, we are requiring that providers explain to beneficiaries the cost-sharing obligation involve d in receiving CCM services and obtain their consent prior to furnishing the se rvice. Practitioners should e xplain that a likely benefit of agreeing to receive CCM services is that although cost-sharing applies to these services, CCM services may help them avoid the need for more costly face to face servic es that entail greater cost-sharing.

Comment: Most of the commenters were c oncerned that the proposed payment would not be adequate for beneficiaries with comple x needs who would benefit the most from CCM

services. Most of the commenters recommended th at we adopt more than one code to provide differential payment for more and less complex beneficiaries, using CP T CCM codes, G-code(s)CMS-1612-FC 454

or some combination thereof. Many commenter s distinguished between beneficiaries that require significantly different clinical re sources--those needing “complex chronic care management” and those needing only “standard ch ronic care or disease management.” Some

commenters asserted that there is a disconnect between the code descriptor for GXXX1 and the Medicare CCM scope of service, such that ambi guity in the descriptor will result in use of GXXX1 to treat a very broad spec trum of beneficiaries inconsiste nt with the scope of service

that the commenters believed was consistent with beneficiaries with more complex needs. They believed the proposed payment amount is appropria te for beneficiaries on needing only standard chronic care management, but w ould significantly underpay for be neficiaries requiring complex chronic care management. Many commenters recommended that CMS adopt the three CPT codes describing chronic care management. In addition to the CPT code th at is similar to the G-code described above (CPT code 99490), there are two additional complex chronic care coordination codes (a base code and an add-on code). Since CY 2013 when the complex chronic care coordination codes became available, CMS has bundled these codes. The base code is CPT code 99487 (Cmplx chron care w/o pt visit), and the add-on is CP T code 99489 (Complex chronic care coordination services; each additional 30 minutes of clinical staff time directed by a physician or other qualified health care professional, per calendar m onth (list separately in addition to code for primary procedure). Other commenters recommended using two codes to describe CCM for different patient populations, or a base code and an add-on code to describe CCM for a single patient population. Some commenters recommended adoption of GXXX1 or CPT code 99490, plus CPT code 99487 along with the RUC-recommended va lues, to describe CCM for the two distinct populations thatCMS-1612-FC 455

require different services. These commenters st ated that there is no “typical” patient that characterizes both groups of patie nts, and that a large number of eligible beneficiaries (those having 2 or more chronic conditions) have seri ous mental health and/or substance abuse disorders and would benefit greatly from CCM services). Other commenters recommended using two G-codes, one being an add-on code fo r each additional 20 minutes or other time spent caring for a beneficiary with mo re complex needs. One commenter urged CMS to adopt an addon code for time increments over 60 minutes . Several commenters recommended a cap on additional minutes, particularly if CMS finalizes an applicable beneficiary coinsurance for CCM

services. One commenter recommended that we finalize the proposed valuation for GXXX1, also recognize CPT code 99490 (Chron care mgmt srvc 20 min) with a higher payment amount, and then collect data on the impact s of differential payment amounts.

Other commenters recommended that CMS adopt CPT code 99487 (Cmplx chron care w/o pt visit) with the scope of services for GXXX1. One commenter recommended that CMS redefine its requirements and the scope of serv ices for GXXX1 to be more consistent with chronic disease management, using CPT code 99487. The commenter believed we should adopt CPT code 99487 with the RUC-recommended valuation. One commenter more generally recommended that CMS adopt a higher intensit y code for patients requiring 45-60 minutes or more of clinical staff time for assessment, medication management, care planning, coordination, education and advocacy. Response: At this time, we believe that Medicare beneficiar ies with two or more chronic

conditions as defined under the CCM code can bene fit from care management and want to make

this service available to all su ch beneficiaries. Like all services, we recognize that some

beneficiaries will need more services and some less, and thus we pay based upon the typicalCMS-1612-FC 456

service. However all scope of service elements apply for delivery of CCM services to any eligible Medicare beneficiary. We will evaluate th e utilization of this service to evaluate what types of beneficiaries receive the service described by this CPT code , what types of practitioners are reporting it, and consider any changes in paym ent that may be warranted in the coming years. We are maintaining the status indicator “B” (Bundled) for CY 2015 for the complex care coordination codes, CPT codes 99487 and 99489. Comment: Several commenters requested th at CMS create codes specific to remote patient biometric monitoring (recording vital si gns and other physiological data and transmitting real-time data to physicians). Several commenter s requested codes specific to or inclusive of certain hematology, nephrology, endocrine and a llergy/immunology conditions, such as chronic kidney disease, end-stage renal disease, di abetes and severe asthma. One commenter recommended that CMS delay implementation of this service for CY 2015 and propose for CY 2016 specific complex chronic care codes for each of the major chronic diseases, especially

diabetes. Response: We are not convinced that the care management services are sufficiently unique based upon the beneficiary’ s specific chronic conditions to warrant separate codes, especially given the beneficiary must have at l east two chronic conditions. As noted above, we will be monitoring this service and will consid er making changes if they appear warranted.

After consideration of the co mments received on this proposal, we are finalizing the proposal with the following modification. Rather than creating a G-code we are adopting the new CPT code, 99490, to describe CCM services effective January 1, 2015. We intend to

evaluate this service cl osely to assess whether the service is targeted to the right population and whether the payment is appropriate for the services being furnishe d. As part of our evaluation,CMS-1612-FC 457

we will consider the whether this new service meets the care coordination needs of Medicare

beneficiaries and if not how best to address the unmet needs.

2. CCM and TCM Services Furnished Incident to a Physician’s Service under General Physician Supervision

In the CY 2014 PFS final rule with comme nt period (78 FR 74425 through 74427), we discussed how the policies relating to services fu rnished incident to a practitioner’s professional services apply to CCM services. (In this disc ussion, the term practiti oner means both physicians and NPPs who are permitted to bill for services furnished incident to their own professional services.) Specifically, we a ddressed the policy for counting clinical staff time for services furnished incident to the billing practitioner’s services toward the minimum amount of service time required to bill for CCM services. We established an exception to the usual rules that apply to se rvices furnished incident to the services of a billing practiti oner. Generally, under the “inciden t to” rules, practitioners may

bill for services furnished incident to their own services if the services meet the requirements specified in our regulations at §410.26. One of these requiremen ts is that the “incident to”

services must be furnished under direct s upervision, which means that the supervising practitioner must be present in the office suite and be immediatel y available to provide assistance and direction throughout the service (but does not mean that the supervising practitioner must be present in the room where the service is furnished) . We noted in last year’s PFS final rule with comment period that, because one of the required elements of the CCM service is beneficiary access to the practice 24-hours-a-day, 7-days-a-wee k, to address the beneficiary’s chronic care needs (78 FR 74426), we expect th e beneficiary to be provided with a means to make timely contact with health care providers in the practice whenever nece ssary to address chronic careCMS-1612-FC 458

needs regardless of the time of day or day of the week. In th ose cases when the need for contact

arises outside normal business hours , it is likely that the beneficiary’s initial contact would be with clinical staff employed by the practice (for example, a nurse) and not necessarily with a practitioner. Under these circumstances, it w ould be unlikely that a practitioner would be available to provide direct supervision of the service. Therefore, in the CY 2014 PFS final rule with comment period, we created an exception to the generally applicable requirement that “inc ident to” services must be furnished under direct supervision. Specifically, we finalized a policy to require only general, rather than direct, supervision when CCM services ar e furnished incident to a practit ioner’s services outside of the practice’s normal business hours by clinical staff who are direct employees of the practitioner or practice. We explained that, give n the potential risk to beneficiar ies that the exception to direct supervision could create, we be lieved that it was appropriate to design the exception as narrowly as possible (78 FR 74426). The direct employment requirement was intended to balance the less stringent general supervision requi rement by ensuring that there is a direct oversight relationship between the supervising practit ioner and the clinical staff personnel who provide after-hours

services. In the CY 2015 PFS proposed rule, we proposed to revise the policy that we adopted in the CY 2014 PFS final rule with comment period. We also proposed to amend our regulations to codify the requirements for CCM and TCM servic es furnished incident to a practitioner’s services. Specifically, we proposed to remove th e requirement that, in order to count the time spent by clinical staff providing aspects of CCM services toward the CCM time requirement, the clinical staff person must be a di rect employee of the practitioner or the practitioner’s practice. (We note that the existing requirement that th ese services be provide d by clinical staff,CMS-1612-FC 459

specifically, rather than by othe r auxiliary personnel is an elem ent of the service for both CCM and TCM services, rather than a requirement im posed by the “incident to” rules themselves.) We also proposed to remove the restriction that services provid ed by clinical staff under general (rather than direct) supervision ma y be counted only if they are provided outside of the practice’s normal business hours. Under our proposed revised policy, then, the time spent by clinical staff providing aspects of CCM services can be count ed toward the CCM time requirement at any time, provided that the clinical staff are under th e general supervision of a practitioner and all other requirements of the “incident to” regulations at §410.26 are met. We proposed to revise these aspects of the po licy for several reasons. First, one of the required elements of the CCM service is the availa bility of a means for the beneficiary to make

contact with health care practitioners in the practice to addr ess a beneficiary’s urgent chronic care needs (78 FR 74418 through 74419) . Other elements within th e scope of CCM services are similarly required to be furnished by practitioners or clinical staff. We believe that these elements of the CCM scope of se rvice require the presence of an organizational infrastructure sufficient to adequately support CCM services, ir respective of the nature of the employment or contractual relationship between th e clinical staff and the practi tioner or practice. We also believe that the elements of the CCM scope of se rvice, such as the requirement of a care plan, ensure a close relationship between a practiti oner furnishing ongoing care for a beneficiary and clinical staff providing as pects of CCM services under general supervision; and that this close working relationship is sufficient to render a requ irement of a direct employment relationship or direct supervision unnecessary. Under our proposa l, CCM services could be furnished “incident to” if the services are provided by clinical st aff under general supervis ion of a practitioner whether or not they are direct employees of the practitioner or practice th at is billing for theCMS-1612-FC 460

service; but the clinical staff must meet the other requirements for auxiliary personnel including those at §410.26(a)(1). Other than the exception to permit general supervision for clinical staff, the same requirements apply to CCM services furn ished incident to a pr actitioner’s professional services as apply to other “incident to” services. Furthermore, since last year’s final rule, we have had many consultations with physicians and others about the organizational structures and other factors that contribute to effective provisi on of CCM services. These consultations have convinced us that, for purposes of clinical staff provi ding aspects of CCM services, it does not matter whether the practitioner is directly avai lable to supervise because the nature of the services are such that they can be, and frequen tly are, provided outside of normal business hours or while the physician is away from the office during normal business hours. This is because, unlike most other services to which the “incident to” rules apply, the CCM services are intrinsically non-face- to-face care coordination services. In conjunction with this proposed revisi on to the requirements for CCM services provided by clinical staff in cident to the services of a practitio ner, we also proposed to adopt the same requirements for equivalent purposes in relation to TCM serv ices. As in the case of CCM, TCM explicitly includes separate payment for serv ices that are not necessarily furnished face-toface, such as coordination with other providers and follow-up with beneficiaries. It would also not be uncommon for auxiliary pe rsonnel to provide elements of the TCM services when the physician was not in the office. Generally, we believe that it is appropriate to treat separately

billable care coordination servic es similarly whether in the form of CCM or TCM. We also

believe that it would be appropriate to apply the same “incid ent to” rules that we are proposing

for CCM services to TCM services. We did not propose to extend this policy to the required face-to-face portion of TCM. Rather, the required face-to-face portion of the service must stillCMS-1612-FC 461

be furnished under direct supervision. Therefore, we proposed to revise our regul ation at §410.26, which sets out the applicable requirements for “incident to” services, to perm it TCM and CCM services provided by clinical

staff incident to the services of a practitioner to be furnished u nder the general supervision of a physician or other practitioner. As with other “incident to” services, the physician (or other practitioner) supervising the a uxiliary personnel need not be the same physician (or other practitioner) upon whose professional service the “incident to” service is based. We note that all other “incident to” requirements continue to appl y and that the usual documentation of services provided must be included in the medical record. Commenters uniformly supported our proposal to revise our regulation at §410.26, which sets out the applicable requireme nts for “incident to” services, to permit TCM and CCM services provided by clinical staff incident to the services of a pr actitioner to be furnished under the general supervision of a physician or other practitioner. Under the revised regulation, then, the time spent by clinical staff providing aspects of TCM and CCM services can be counted toward the TCM or CCM time requirement at any time, pr ovided that the clinical staff are under the general supervision of a practitioner and all require ments of the revised “incident to” regulations at §410.26 are met. Comment: One commenter requested guidance concerning whether (as has been the case with E/M codes) activities billed under “incident to ” will not be able to also be billed under the

CCM code. Response: The purpose of our proposal was to allow elements of CCM services that are furnished by clinical staff incide nt to a practitioner’s profession al services (under the “incident to” regulations) to be included and reported as CC M services. We are not entirely clear what theCMS-1612-FC 462

commenter is asking, but the time spent furnishi ng CCM services can only be counted once and for only one purpose, and each discrete service can be billed only once. Although we and our contractors provide many educati onal materials, practitioners who furnish Medicare covered items and services are responsible for lear ning how to appropriate ly bill each service. Comment: One commenter urged us to revise the terminology by which we define the

CCM and TCM services to reflec t non-hierarchical interdiscip linary team care, rather than relying on an incident-to structur e that obscures the actual provider of direct patient care. This commenter expressed concern about loss of benefits to clinicians under contract with a practice, rather than being employed by the practice. Another commenter similarly expressed concern that the expanded authorization for “general superv ision” rather than “direct supervision” would provide an even greater incentive for physicians to require that any E/M service provided by an Advanced Practice Registered Nurse (APRN) in their practice be billed as “incident to” a physician’s service. This could reduce transpar ency in billing data and diminish accountability

for services for Part B beneficiaries. Response: We do not entirely understand th e basis for these concerns. We have accommodated numerous requests to include contracted employees within the scope of the “incident to” rules for purposes of counting ti me toward the TCM and CCM requirements. We have not otherwise proposed to revise the “i ncident to” and other regulations within which practitioners operate as they make decisions about whether to contra ct or directly employ clinical staff, or about how to bill for services provide d. Although they are importa nt within the context of the new TCM and CCM services, we believe that the revisions to our “incident to” regulation that are adopted in this final rule, are periphe ral in the context of the overall employment and billing practices of physicians and group practices.CMS-1612-FC 463

After consideration of the comments, we are finalizing our proposal to revise our regulation at §410.26, which sets out the applicable requirements fo r “incident to” services, to permit the CCM and non-face-to-face portion of the TCM services provided by clinical staff

incident to the services of a practitioner to be furnished unde r the general supervision of a physician or other practitioner. 3. Scope of Services and Standards for CCM Services In the CY 2014 final rule with comment period (78 FR 74414 through 74428), we defined the elements of the scope of service fo r CCM that are required for a practitioner to bill Medicare for the CCM service. In addition, we i ndicated that we intended to develop standards for practices that furnish CCM services to ensure that the practitioners who bill for these services have the capability to fully furnish them (78 FR 74415, 74418). At that time, we anticipated that we would propose these standards in the CY 2015 PFS proposed rule. We actively sought input toward development of these standards by so liciting public comments on the CY 2014 PFS final rule with comment period, through outreach to stakeholders in meetings, by convening a Technical Expert Panel, and by co llaborating with federal partne rs such as the Office of the Assistant Secretary for Planning and Evaluation, the Office of the Assistant Secretary for Health,

the Office of the National Coordinator for H ealth Information Technology (ONC), and the

Health Resources and Services Administration. Our goal is to recognize the trend toward practice transformation and overall improved qua lity of care, while preventing unwanted and

unnecessary care. As we worked to develop appropriate practi ce standards that would meet this goal, we consistently found that many of the standard s we thought were important overlapped in significant ways with the scope of service or with the billing requirements for the CCM servicesCMS-1612-FC 464

that had been finalized in the CY 2014 final ru le with comment period. In cases where the standards we identified were not unique to CCM requirements, we found that the standards overlapped with other Medicare requirements or other federal re quirements that apply generally to health care practitioners. Based upon the feedback we received, we sought to avoid duplicating other requirements or, worse, imposing conflicting requirements on practitioners that

would furnish CCM services. Given the standard s and requirements that are already in place for health care practitioners and a pplicable to those who furnish and bill for CCM services, we decided not to propose an additional set of standa rds that would have to be met in order for practitioners to furnish and bill for CCM services . Instead of proposing a new set of standards applicable to only CCM services, we decided to emphasize that certain requirements are inherent in the elements of the existing sc ope of service for CCM services, and clarify that these must be

met in order to bill for CCM services. The CCM scope of service elements finalized in the CY 2014 PFS final rule (78 FR 74414 through 74428) are as follows.

● The provision of 24-hour-a-day, 7-day-a-week access to address the patient’s acute chronic care needs. To accomplish this, the pa tient must be provided with a means to make timely contact with health care providers in the practice to address the patient’s urgent chronic care needs regardless of the time of day or day of the week.

● Continuity of care with a designated prac titioner or member of the care team with whom the patient is able to ge t successive routin e appointments.

● Care management for chronic conditions including systematic assessment of the patient’s medical, functional, and psychosocial need s; system-based approaches to ensure timely receipt of all recommended preventive care servic es; medication reconcilia tion with review of adherence and potential interacti ons; and oversight of patient self -management of medications.CMS-1612-FC 465

• In consultation with the patie nt, any caregiver and other ke y practitioners treating the patient, the practitioner furnishing CCM services must create a patient- centered care plan document to assure that care is provided in a way that is congruent with patient choices and values. The care plan is based on a physical, me ntal, cognitive, psychos ocial, functional and environmental (re)assessment and an inventory of resources and supports. It is a comprehensive plan of care for all health i ssues, and typically includes, but is not limited to, the following elements: problem list, expect ed outcome and prognosis, measurable treatment goals, symptom management, planned interventions, medicati on management, community/social services ordered, how the services of agencies and specialis ts unconnected to the b illing practice will be directed/coordinated, identify the individuals re sponsible for each intervention, requirements for periodic review and, when applicable, revisi on of the care plan. A full list of problems, medications and medication allergies in the EHR must inform the care plan, care coordination and ongoing clinical care.

● Management of care transitions within health care, including referrals to other clinicians, follow-up after the patient’s visit to an emergency department, and follow-up after discharges from hospitals, skilled nursing facilities, or other health care facilities. The practice

must facilitate communication of relevant patient information through electronic exchange of a summary care record with other health care provi ders regarding these transitions. The practice must also have qualified personnel who are available to deliver tr ansitional care services to the patient in a timely way so as to reduce the need for repeat visits to emergency departments and readmissions to hospitals, skilled nursing f acilities or other h ealth care facilities.

● Coordination with home and community base d clinical service providers required to support the patient’s psychosocial needs and functional deficits. Communication to and fromCMS-1612-FC 466

home and community based providers regarding th ese patient needs must be documented in the patient’s medical record.

● Enhanced opportunities for the beneficiary and any releva nt caregiver to communicate with the practitioner regarding the beneficiary’ s care through, not only telephone access, but also through the use of secure messaging, intern et or other asynchronous non face-to-face

consultation methods. Similarly, we reminded stakeholders of th e following additional billing requirements

established in the CY 2014 final rule with co mment period (in the following list, we have changed the service period from the 2015 propos ed 30-day period to the final 2015 service period of one calendar month):

● Inform the beneficiary about the availability of the CCM services from the practitioner and obtain his or her written agreement to have the services provided, in cluding the beneficiary’s

authorization for the electronic communication of the patient’s medical information with other treating providers as part of care coordination.

● Document in the beneficiary’s medical r ecord that all elements of the CCM service were explained and offered to th e beneficiary, and note the benefi ciary’s decision to accept or

decline the service.

● Provide the beneficiary a wr itten or electronic copy of the care plan and document in

the electronic medical record that the car e plan was provided to the beneficiary.

● Inform the beneficiary of the right to st op the CCM services at any time (effective at the end of a calendar month) a nd the effect of a revocation of the agreement to receive CCM

services.CMS-1612-FC 467

● Inform the beneficiary that only one pr actitioner can furnish and be paid for these services during the calendar month service period. In one area, electronic health records (EHRs), we were concerned that the existing elements of the CCM service could leave some gaps in assuring that beneficiaries consistently receive care management services that offer the benefits of advanced pr imary care as it was

envisioned when this service was created. It is clear that effective care management can be accomplished only through regular monitoring of the patient’s health status, needs, and services, and through frequent communicatio n and exchange of informati on with the patient and among the various health care practitione rs and providers treating the pa tient. After gathering input from stakeholders through the CY 2014 rulemaki ng cycle, for 2015 we proposed a new scope of service element that would require use of a certifi ed EHR and electronic care planning to furnish CCM services. We believed that requiring thos e who furnish CCM services to utilize EHR technology that has been certifi ed by a certifying body authorized by the National Coordinator for Health Information Technology was necessary to ensure that key patient information is stored, shared and reconciled among the many pract itioners and providers involved in managing the patient’s chronic conditions, otherwise ca re could not be coor dinated and managed. Requiring a certified EHR would enable members of the interdisciplinary care team to have immediate access to the most updated informati on informing the care plan. Therefore we proposed that the billing practitioner must utilize EHR technology certified by a certifying body authorized by the National Coordinator for Health Information Technology to an edition of the

EHR certification criteria identi fied in the then-applicable ve rsion of 45 CFR part 170. We proposed that at a minimum, the practice must utilize EHR technology that meets the certification criteria adop ted at 45 CFR 170.314(a)(3), 170.314(a)(4), 170.314(a)(5),CMS-1612-FC 468

170.314(a)(6), 170.314(a)(7) and 170.314(e)(2) pertai ning to the capture of demographics, problem lists, medications, and other key elemen ts related to the ultimate creation of an electronic summary care record. These sections of the regulation comprise the certification criteria for specific core technology capabilit ies (structured recording of demographics, problems, medications, medication allergies, and the creation of a structured clinical summary) for the 2014 edition. Under the proposal, pract itioners furnishing CCM services beginning in CY 2015 would be required to utili ze an EHR certified to at least these 2014 editi on certification

criteria. Given these 2014 edit ion criteria, the EHR technology would be certified to capture data and ultimately produce summary records ac cording to the HL7 Consolidated Clinical

Document Architecture standard (see 45 CFR 170.205(a)(3)). In addition, when any of the CCM scope of serv ice elements refers to a health or medical record, we proposed to require use of an EHR cer tified to at least the 201 4 edition certification criteria to fulfill the scope of service element in relation to the health or medical record. As finalized in the CY 2014 PFS final rule, the scope of service elements that reference a health or

medical record are:

● A full list of problems, medications and medication allergies in the EHR must inform the care plan, care coordinati on and ongoing clinical care.

● Communication to and from home and community based providers regarding the patient’s psychosocial needs and functional deficits must be documented in the patient’s medical

record.

● Inform the beneficiary of the availability of CCM services and obtain his or her written agreement to have the services provide d, including authorizati on for the electronic

communication of his or her medical information with other treati ng providers. Document in theCMS-1612-FC 469

beneficiary’s medical record that all of the CCM services were explained and offered, and note the beneficiary’s decision to accept or decline these services.

● Provide the beneficiary a wr itten or electronic copy of the care plan and document in

the electronic medical record that the car e plan was provided to the beneficiary. Regarding the care plan in particular, we be lieved that requiring practitioners furnishing

CCM services to maintain and share an electronic care plan would alleviate the errors that can occur when care plans are not syst ematically reconciled. To ensu re that practices offering CCM services meet these needs, we proposed that CCM services must be furnis hed with the use of an

EHR or other health IT or health information exch ange platform that includes an electronic care plan that is accessible to all practitioners within the practice, including being accessible to those who are furnishing care outside of normal busine ss hours, and that is available to be shared electronically with care team memb ers outside of the practice. This was a more limited proposal compared to our CY 2014 proposal that we did no t finalize that would ha ve required members of

the chronic care team who are involv ed in the after-hours care of the patient to have access to the beneficiary’s full electronic medical record (78 FR 74416 through 74417). Regarding the clinical summary, we proposed to require technology ce rtified to the 2014

edition for the electronic creation of the clinic al summary, formatted acc ording to the standard adopted at 45 CFR 170.205(a)(3), but we did not sp ecify that this format must be used for the exchange of beneficiary information (79 FR 40367). For instance, we did not propose that practitioners billing for CCM serv ices must adopt certified technol ogy related to the exchange of a summary care record such as the transmission st andard related to Direct Project Transport in 45 CFR 170.314(b)(2)(ii).CMS-1612-FC 470

We indicated that we believed our proposed ne w scope of service element for a certified EHR and electronic care planning would ensure that practitioners billing for CCM could fully furnish the services, allow practitioners to innov ate around the systems that they use to furnish these services, and avoid overburdening small pract ices. We indicated that we believed that allowing flexibility as to how practitioners cap ture, update, and share care plan information was important at this stage given the maturity of cu rrent EHR standards and other electronic tools in use in the market today for care planning. In addition to seeking comment on this new proposed scope of service element, we sought comment on any changes to the scope of service or billing requirements for CCM services that may be necessary to ensure that th e practitioners who bill for these services have the capability to furnish them and that we can appropr iately monitor billing for these services. With

the addition of the electronic health information technology el ement that we proposed, we believed that the elements of the scope of serv ice for CCM services, when combined with other important federal health and safety regulations, would provi de sufficient assurance that practitioners billing for CCM could fully furnish the services, and that Medicare beneficiaries receiving CCM would receive appr opriate services. However we expressed special interest in receiving public feedback regard ing any meaningful elements of the CCM service or beneficiary protections that may be missing fr om the scope of service elements and billing requirements. The following paragraphs summarize the comments we received regarding these elements of the scope of service for CCM services and our responses.

Comment: Some commenters we re disappointed that CMS di d not propose an additional set of standards. The commenters expressed concern that there would not be sufficient accountability for high quality CCM services . Some commenters recommended furtherCMS-1612-FC 471

development of standards such as inclusi on of evidence-based self-management programs offered by community organizations, quality meas ures that engage pati ents and demonstrate improved outcomes, or a best practices guide to assist the physician community with implementation. However, many commenters opposed further standards, and agreed with CMS that additional standards would largely overlap with other Medicare re quirements or were already reflected in the scope of service elements. Response: We appreciate the commenters’ conc erns about ensuring quality of care. We

continue to believe that with the addition of the EHR element, the re quired scope of service elements are sufficient for ensuring high quality CCM services in 2015. We note that section III.K of this final rule with comment period addr esses quality measures for physicians’ services, and stakeholders may submit suggestions for quality measures related to CCM in response to this section of the regulation. Comment: Many commenters expressed br oad support for our EHR proposal. The commenters commended the strong emphasis on data sharing and requirements for a robust EHR

as vital to successful care coordination and c ontinuity of care. Several commenters did not believe the proposal would pose a significant admi nistrative burden. One commenter noted that use of an EHR would help practitioners to document the time spent furnishing CCM services. Although commenters supported adoption of certified EHR technology (CEHRT) generally, many were concerned that an insuffi cient number of physicians have adopted CEHRT with the functionalities we proposed for CCM, especi ally interoperability with other providers. The commenters were also concerned that phys icians practicing in rural or economically depressed areas would not have the resources to implement such technology and would be disqualified from furnishing separately billable CCM services. Many believed the proposal wasCMS-1612-FC 472

laudable but premature, recommending that CM S delay adoption of th e 2014 EHR certification criteria for CCM services by 3 to 4 years when th ey will be more widely adopted, or phase in the 2014 certification criteria over 2 years as a requirement for 2017. Several commenters recommended that we finalize our proposal but pr ovide hardship exceptions for certain smaller or rural practices to enable them to bill sepa rately for CCM services in the absence of an interoperable EHR in certain circumstances, pr ovide financial incentives, or allow other flexibility around the requirements for physicians who cannot meet them at this time. One commenter supported the proposal but suggested we allow aspects of CCM services to be furnished using fax and secure messaging techno logy if physicians encounter challenges with interoperability. Until EHR sy stems are interoperable, some commenters suggested allowing practitioners to attest that all requirements for billing CCM were met using CEHRT or an alternative technology, or to attest that all members of the care team have timely access (24/7

access in “real time” or “near real time”) to the most updated info rmation regarding the care plan through either electronic or non-electronic means, with ongoing efforts to implement interoperable EHRs. The commenters stated many practices are making patient information accessible in a timely manner to the entire care te am, but have not yet fully implemented an interoperable EHR with other pr oviders. Several commenters we re concerned about the ability of current EHR technologies to share informati on across different providers and EHR systems. Commenters requested that CMS ensure that no certified EHR contains technological or business impediments to data sharing across disparate technology platforms used by multiple providers trying to coordinate care. In addition, many commenters were concerned about access to CCM services, and recommended that CMS prioriti ze access over adoption of CEHRT. SeveralCMS-1612-FC 473

commenters stated that not all t ypes of physicians have access to an EHR that meets the needs of their specialty.

A number of commenters stated that CCM could be (and alre ady is) effectively provided without any EHR or a without a certified EHR, and recommended that CM S rescind the proposal or make the EHR requirement optional. These commenters disagreed with the requirement that

CCM services must be furnished with use of a certified EHR, information technology (IT) platform or exchange platform that includes a ca re plan, with some sta ting that certified EHR systems have not demonstrated improvements in the management of chronic conditions, especially complex cases, and suggested postpon ing the care plan and other EHR requirements until they are proven effective and adopted by most providers. Others stated that an EHR was necessary and that CMS should require an EH R that promotes communication among various professional on the care team, includes the patient as part of the team, and enables clinical monitoring and effective care planning. Commente rs indicated that many physicians accomplish this through generating or receiv ing electronic discharge summari es, clinical documentation, and patient-centered plans of care, but are not us ing certified technologies to carry out these functions and should not be penalized. One commenter stated that only about half of all physicians had an EHR system with advanced functionalities in 2013, many current system s were not designed with interoperability in mind and transition costs are high. The co mmenter believed the proposed payment amount would not sufficiently cover the cost of purchas ing or upgrading an EHR system, and requiring a

certified EHR would limit the numbe r of eligible physicians wit hout significantly adding value

to CCM services. Another commenter stated th at only 1,000 physicians and other eligible healthCMS-1612-FC 474

professionals have achieved St age 2 of Meaningful Use of certified EHR technology, compared with more than 300,000 physicians and eligible professionals who have achieved Stage 1. Response: We continue to believe that it is necessary to re quire the use of EHR technology that has been certified under the ONC Health IT Cert ification Program as requisite for receiving separate payment for CCM services, to ensure that practitioners have adequate capabilities to allow members of the interdisciplin ary care team to have timely access to the most updated information informing the care plan. We ag ree with commenters that health IT tools are most effective when there are no technological or business impediments to data sharing, or disparate technology platforms used by multiple providers trying to coordinate care, and that we

should ensure common functionalities as much as possible across providers. However, we also agree with commenters who expressed concern th at requiring the most recent edition of EHR certification criteria could be an impediment to the broad utilization of the CCM service. In response to comments, we are modifying our pr oposal regarding which edition of certified EHR technology will be required, in order to allow more flexibility as practitio ners transition to the use of certified EHR technology. Accordingly, we ar e modifying our proposal to specify that the CCM service must be furnished using, at a minimum, the edition(s) of certification criteria that is acceptable for purposes of the EHR In centive Programs as of December 31 st of the calendar year preceding each PFS payment year (hereinafter “ CCM certified technology”) to meet the final core technology capabilities (str uctured recording of demogra phics, problems, medications, medication allergies, and the creation of a structur ed clinical summary). Practitioners must also use this CCM certified technology to fulfill the CCM scope of service requirements whenever the requirements reference a health or medical record. This will ensure that requirements for CCM billing under the PFS are consistent throughout each PFS payment year and areCMS-1612-FC 475

automatically updated annually according to the certification criteria required for the EHR Incentive Programs. For CCM payment in CY 2015, this policy will allow practitioners to use EHR technology certified to either the 2011 or 2014 edition(s) of cer tification criteri a to meet the final core capabilities for CCM and to fulfill the CCM scope of service requirements whenever the requirements reference a health or medical record. We are finalizi ng the separate provision we proposed for the electronic care plan scope of service element w ithout modification as

discussed below. We remind stakeholders that for all electronic sharing of beneficiary information under our final CCM policies, HIP AA standards apply in the usual manner. Comment: Several commenters questioned th e relationship between the Meaningful Use criteria and the proposed EHR scope of service element for CCM. One commenter stated that none of the requirements for EHR capability for payment of CCM services should be tied to or related to Meaningful Use, b ecause many of the Meaningful Us e requirements do not apply to CCM. Another commenter supported what they unde rstood to be our propos al, to require billing physicians to adopt an EHR and utilize it to meet the most recent standard for Meaningful Use. However, the commenter noted (similar to the previous commenter) that the current functionalities and standards for EHR technology required for Meaningful Use are not entirely aligned with the functionalities required for CCM , for example the commenter believed that the electronic care plan need only be shared 10 percent of the time to meet Meaningful Use measures, but that CCM would require it to be available 24/7 and to all practitioners. The commenter expressed concern that practitioners might not be able to furnish CCM as envisioned by CMS due to discrepancies with the Meani ngful Use criteria, and urged CMS to adopt interoperability standards for M eaningful Use that would enable successful care coordination

models. Another commenter recommended that en forcement of the proposed EHR requirementCMS-1612-FC 476

be coterminous with the enforcement of Meaningf ul Use Stage 2 to ensure practices have the ability to comply. Response: Although we understand why some commenters would like for the requirements for the EHR Incentive Programs and th e EHR scope of service element for CCM to be identical, we do not believe that is entire ly possible because of the different nature and purpose of the respective EHR specifications. In many respects they are not comparable requirements. For example, the PFS sets paym ent requirements prospectively for a given calendar year, while the EHR Incentive Program may change requirements mid-year. In addition, many of the Meaningful Use measures are not relevant for th e provision of CCM and we believe we should only require practitioners to adopt the certifi ed technology that is relevant to the scope of CCM services. In their attempts to meet Meaningful Use cr iteria for a given year, practitioners are required to use technology certif ied to a specific edition(s) of certification criteria to meet the CEHRT definition, and as we discussed above we are aligning the edition required to bill CCM with the edition(s) required for Meaningful Use each year. However, it is conceivable that a practitioner could use CCM certified technology to provide and be paid for CCM in a given calendar year that will not be su fficient for achieving Meaningful Use in that same year because CCM must be furnished us ing at least the editi on(s) of certified EHR technology required for the EHR Incen tive Programs as of December 31 st of the prior calendar year. Also, it is possible that a practitioner could us e technology certified to an edition that qualifies for CCM payment that could also be used to achieve Meaningful Use for a given calendar year, but still not meet the objectives and associated meas ures of a particular stage of Meaningful Use that are require d to qualify for an EHR Incentive payment or avoid a downward adjustment to payments. As the commenters noted, the Meaningful Use measures are not allCMS-1612-FC 477

relevant to the provision of CCM services, and the pr actitioner may not have sufficient certified technology to support all the necessary or releva nt Meaningful Use objectives and measures under the EHR Incentive Programs. Certified technol ogy is used in different ways to meet the requirements of each program. We believe that th e policy we are finalizing here aligns the CCM scope of service element to the extent appropriate with the EHR Incentive Programs to achieve maximum consistency.

Comment: Several commenters asked us to cl arify the requirement for the electronic care plan in relationship to the overall requirement fo r a certified EHR and in relationship to the 24/7 access requirement. The commenters stated they were not sure whether these proposals were independent provisions or impacted one another. The commenters stated that if CMS intended these as independent provisions, the agency shou ld identify objective criteria to evaluate whether a particular health IT product ha s adequate capabilities to meet the separate requirement for the electronic care plan. The commenters stated they were not sure whether the electronic care plan would require a certified EHR, or whether there would be an ex ception to use of CEHRT for the care plan. The commenters recommended flexibility in how practitioners and providers capture, develop, update and share care plan inform ation. One commenter recommended that if practitioners must attest to use of a qualifying electronic care plan, CMS should only require a simple yes/no response to minimize billing impedi ments. One commenter asked us to clarify the required elements of the care plan in relation to different EHR systems. In addition, several commenters requested that we clarify whether the care plan must be electronically accessible 24/7 to all providers tr eating the patient’s chronic conditions, those within the billing practice, or those within th e billing practic e who are communicating with the patient after hours. The commenter s noted that providers other th an the billing practitioner mayCMS-1612-FC 478

not use the same certified EHR, so it would be unreasonable to expect the same care plan and

other relevant information to be accessible to all providers at all times. Other commenters believed we proposed flexibility around the ce rtified EHR requirement in relation to the electronic care plan, and suppor ted this proposed flexibility. Response: Regarding the care plan, we proposed that CCM se rvices must be furnished

with the use of an EHR or othe r health IT or health inform ation exchange platform (not necessarily a certified EHR) that includes an electron ic care plan that is accessible at all times to the practitioners within the practice, includi ng those who are furnishing CCM outside of normal business hours. By practitioners “within the practice,” we mean any practitioners furnishing

CCM services whose minutes count towards a given practice’s time requirement for reporting the CCM billing code. In addition, we proposed that the electronic care plan must be available to be shared electronically with care team members outside the practice (w ho are not billing for CCM). We sought to convey that practitioners could satisf y these requirements related to the care plan without using the certif ied EHR technology. We specified th at the certified EHR technology is only required to accomplish activities described in the scope of service elem ents that specifically

mention a medical record or EHR. We said that a full list of problems, medications and medication allergies in the certified EHR (which would follow structured recording formats)

must inform the care plan, not that the care plan itself must be created or transmitted among providers using certified EHR technology. We note that this was a limited proposal compared to our CY 2014 proposal that we did not finalize that would have required members of the chronic

care team who are involved in the after-hours care of the patient to have access to the patient’s

full electronic medical record instead of just the care plan (78 FR 74416 through 74417).CMS-1612-FC 479

Through separate requirements for the electr onic care plan and th e certified EHR, our intent was to require practitioners to use some form of electronic technol ogy tool or service in fulfilling the care plan element (other than facs imile transmission), rec ognizing that certified EHR technology is limited in its ability to support electronic care planning at this time, and that practitioners must have flexibility to use a wide range of tools and services beyond certified EHR technology now available in the market to support electronic care planning. We intended that all care team members furnishing CCM services that are billed by a given pr actice (contributing to the minimum time required for billing) must have access to the electronic care plan at all times when furnishing CCM services. However, the electronic care plan would not have to be available at all times to other non-billing practices , recognizing that other practices may not be using compatible electronic technology or partic ipating in a health in formation exchange. We are finalizing the electronic care plan and 24/7 access elements as proposed, clarifying that to satisfy the care plan scope of service element, practitioners must electronically capture care plan information and make this in formation available to all care team members furnishing CCM services that are billed by a given practice (counting towards the minimum monthly service time), even when furnishi ng CCM outside of normal business hours. In addition, practitioners must electr onically share care plan informa tion as appropriate with other providers and practitioners who ar e furnishing care to the patient . We are not requiring that practitioners use a specific el ectronic technology to meet the re quirement for 24/7 access to the care plan or its transmission, only that they us e an electronic technology other than facsimile. For instance, practices may sati sfy the 24/7 care plan access re quirement through remote access to an EHR, web-based access to a care manageme nt application, or web-based access to a health information exchange service that captures and maintains care plan information. Likewise, weCMS-1612-FC 480

are not requiring that prac titioners use a specific electronic technology to meet the requirement to share care plan information electronically with other practitioners and providers who are not billing for CCM. For instance, practitioners may meet this sharing requirement through the use of secure messaging or participation in a health information exchange with those practitioners and providers, although they may not use facsimile transmission. While we are not requiring that practitioners use a specific electronic technology at this time (other than not allowing facsimile), we ma y revisit this requirement as standards-based exchange of care plan information become s more widely available in the future. We remind stakeholders that for all electronic sharing of beneficiary information under our final CCM policies, HIPAA standards a pply in the usual manner.

Comment: Several commenters asked us to cl arify the relationship between the certified EHR proposal and the summary record exchange requirement. Commenters believed that CMS had cited specific regulatory prov isions around exchange in the pr oposed rule (identified by the commenter as a Summary Record Exchange (SRE) capability tag, referring to a designation used to identify those products on the Certified Health IT Product List maintained by ONC offering technology certified to criteria around the exch ange of summary care records) and should

consider alternatives. The commenters were not clear as to whether they objected to what they believed to be the proposed format or the transm ission method of the summary record exchange. Response: In the CY 2014 PFS final rule with comment period, as part of the care transitions management scope of service element, we indicated that the pr actice must be able to facilitate the communication of relevant patien t information through electronic exchange of a summary care record with other health care pr oviders (78 FR 74418). We did not specify a standard for the “summary care record” that provi ders must exchange electronically, nor did weCMS-1612-FC 481

specify a method by which providers must f acilitate the communication of beneficiary information, such as use of certified EHR tec hnology. In the CY 2015 PFS proposed rule (79 FR 40367), we proposed that the practitioner must utilize EHR technology certified by a certifying body authorized by the National Coor dinator for Health Informati on Technology to an edition of

the EHR certification criteria iden tified in the then-applicable ve rsion of 45 CFR part 170. Under one of the specific certification criteria cited, we pr oposed that practitioners must use technology that meets the criterion adopted at §170.314(e )(2), which would ensure that they produce summary records formatted according to the standard adopted at §170.205(a)(3). However, we did not propose that this formatting standard must be used for the exchange of patient information, only that in furnishing CCM services , practitioners must format their summaries according to this standard. We did not propose that providers billing for CCM services must adopt any certified technology for the excha nge of a summary care record, such as the

transmission standard related to Direct Project Transport in § 170.314(b)(2)(ii). We recognized that providers are currently exchanging patient in formation to support transitions of care in a variety of meaningful ways beyond the methods specified with 2014 edition certified technology, with the exception of faxing which would not meet the proposed scope of service requirement. The 2014 edition sets specific requirements for tran smission or exchange of the summary record that technology must meet for cer tification, and we expected that only some practitioners could adopt and use such technology in CY 2015. Theref ore we did not constrain practitioners to the exchange functionality in the 2014 edition if they utilized an alternat ive electronic tool. As discussed above, our final policy will a llow practitioners billing the PFS for CCM services to use the edition(s) of certification criteria that is accepta ble for the EHR Incentive Programs as of December 31 st of each calendar year preceding each PFS payment year to meetCMS-1612-FC 482

the final core technology capabilities (struc tured recording of demographics, problems, medications, medication allergies, and the creation of a structur ed clinical summary). (Also practitioners must use this CCM certified t echnology to fulfill the CCM scope of service requirements whenever the requirements reference a health or medical record). Under this final policy, practitioners must format their structured clinical summaries according to, at a minimum, the standard that is acceptable for the EHR Incentive Programs as of December 31 st of the calendar year preceding each PFS payment year. We are finalizing our proposal that practit ioners must communicate relevant patient information through electronic exchange of a summa ry care record to suppor t transitions of care,

with a clarification that practitioners do not have to use a ny specific content exchange standard in CY 2015. We did not propose and are not finali zing a requirement to use a specific tool or service to communicate beneficiary information, as long as providers do so electronically. We note however that faxing will not fulfill this re quirement for exchange of the summary care record. We did not propose to modify our vi ew, discussed in the CY 2014 PFS final rule with comment period, that practitioners furnishing and billing for CCM services must be able to support care transitions through th e electronic exchange of benefi ciary information in a summary care record (78 FR 74418). While certain 2014 edition certificati on criteria address a content standard and transmission method for exchange of a summary record, we con tinue to expect that only some practitioners could adopt and use su ch technology. Moreover, we recognize that providers are currently exchanging patient informa tion to support transitions of care in a variety of meaningful ways beyond the methods specifi ed in 2014 edition certifi cation criteria. We

continue to believe that at le ast for CY 2015, we should allow flex ibility in the selection of the

electronic tool or service that is used to transmit beneficiary information in support of careCMS-1612-FC 483

transitions, as long as practitioners electronica lly share beneficiary information to support transitions of care. Finally we re mind stakeholders that for all electronic sharing of beneficiary information under our final CCM policies, HIP AA standards apply in the usual manner. Comment: Several commenters expressed co ncern about requiring a certified EHR for billing CCM. The commenters were concerne d that CMS would not allow the use of noncertified technologies that may be more innovative and effective than certified technologies. Commenters requested that we clarify whether only the certified EHR (a nd no other electronic tool) could be used to conduct CCM services, for example the use of enhanced communication methods other than telephone. One commenter stat ed that many times the practice will be using the certified EHR system to car ry out such activities, and th ere are strong Meaningful Use incentives to employ the certified EHR for these activities. However, a practice may also have other capabilities and tools that would suppor t elements of the CCM services. These commenters asked us to clarify whether the requi rement to utilize certified EHR technology is a literal statement that only certified EHR technol ogy may be used in furnishing the scope of

service elements for CCM services. Response: We continue to believe that health IT tools are most effective when there are no technological or business impediments to data sharing, or disparate technology platforms used by multiple practitioners trying to coordinate care. For the separately billable CCM service, we believe it is necessary to establish as part of th e scope of the service a ce rtified EHR that allows for the data capture, accessibility and sharing cap abilities necessary to furnish the service. Therefore, we are finalizing our proposal to require use of CCM certified technology to meet the final core technology capabilities (structured recording of dem ographics, problems, medications, medication allergies, and the creat ion of a structured cl inical summary). In addition, whenever aCMS-1612-FC 484

scope of service element references a health or medical record, CCM cer tified technology must be used to fulfill that scope of service element in relation to the health or medical record. We have listed above the current scope of service el ements that include a reference to a health or

medical record. If both CCM certified techno logy and other methods are available to the practitioner to fulfill the final core technology capabilities for CCM (structured recording of demographics, problems, medications, medication allergies, and the crea tion of a structured clinical summary) or the CCM sc ope of service elements refere ncing a the health or medical record, practitioners may only use the certified capability. We remind stakeholders that for all electronic sharing of benefici ary information under our final CCM policies, HIPAA standards apply in the usual manner. Comment: One commenter recommended that we adopt the following additional 2014

EHR certification criteria:

• Patient List Creation (45 CFR 170.314(a)(14)), which would support the required element of service for preventive services and routine appointments, and could help provide registry types of functions for the practice to use in managing patients who have agreed to participate in the chronic care management service.

• Patient-Specific Education Resources (§170.314( a)(15)), which would help assure the ability to provide the patient with relevant e ducational materials about their chronic disease

conditions.

• Clinical Reconciliation (§170.314(b)(4)), wh ich would serve support the medication reconciliation requirement and th e requirement to revi ew patient adherence to their medication regime.

• View/Download/Transmit to a 3rd Party (§170.314(e)(1 )), which would enableCMS-1612-FC 485

patients to access their own elect ronic health record and have access to information related to

their care at thei r own convenience.

• Secure Messaging, Ambulatory Setting Only (§170.314(e)(3)). Response: Some of these 2014 certification criteria are not relevant (have no corollary) in the 2011 certification criteria, so we would not require them because practitioners are not required to use the 2014 edition in CY 2015. In addition, we are requiring that providers use certified EHR technology to fulfill a limited number of the scope of service elements (summarized in Table 33). We are requi ring the certified tec hnology only for certain foundational elements, and believe we should avoid making the EHR requirement for CCM unnecessarily complex at this time. While we agree that the other features of certified EHR products mentioned by the commenter would certai nly help many practitioners fulfill the other elements of the CCM service, practitioners ma y be using tools other than certified technology that are adequate for the required task(s), for ex ample, registry tools fo r patient list creation, educational resources, patient portals, third party reconciliati on services, and secure messaging systems. Comment: We received many comments on the sc ope of service elements other than the EHR, some requesting that we implement additi onal standards. A few commenters said CMS should consider adding a requirement for use of community based providers through a home visit at least once every 12 months to assess the home environment and the need for community based resources, or that CMS should include home and domiciliary care, group vi sits and community

based care. Several commenters wanted us to include “remote patient monitoring” or “patient generated health data” in the scope of services, such as daily remote monitoring of physiology

and biometrics. Several commenters recommende d additional tools for patient self-managementCMS-1612-FC 486

education and training, or “patie nt activation” tools. One co mmenter recommended we require a patient experience survey to assess the patien t’s perspective regarding the CCM services they

receive. Several commenters believed we should expand the medication management and

medication reconciliation element to include mo re comprehensive medication management and more clearly define “review of adhe rence” to the medication regimen. Response: Other than the scope of serv ice element for EHR a nd other electronic technology, we do not believe additional changes to the scope of service elements for CCM are warranted at this time. We are requiring certified EHR technology for certain foundational or “core” elements, including structured recording of medications and medication allergies. As finalized in the scope of servic e in the CY 2014 PFS final rule with comment period we are also requiring medication reconciliation with review of adherence a nd potential inte ractions, and oversight of patient self-management of me dications. We believe it would be overly burdensome, especially given the broad eligible beneficiary population a nd final RVU inputs, to include more specific requirements related to me dication management, especially when greater specificity is likely not necessary to ensure ad equate care. The CCM services are by definition non-face-to-face services; therefore we are not in cluding a requirement for home or domiciliary visits or community based care (although there is a requ irement related to coordinating home and community based care). Practitioners who engage in remote monitoring of patient physiological data of eligible beneficiaries may count the tim e they spend reviewing the reported data towards the monthly minimum time for billing the CCM c ode, but cannot include the entire time the beneficiary spends under monitoring or wearing a monitoring device. If we believe changes to the scope of service elements are warranted in the future, we will propose them through notice and comment rulemaking taking the comments we received to date in to consideration.CMS-1612-FC 487

Comment: We received many comments on the scope of service elements other than the EHR, requesting that CMS implement fewer stan dards. Some commenters believed that other than the “incident to” provisions , the scope of service elements are administratively burdensome and it will be difficult for physicians to adequa tely document that they have fulfilled the requirements. Several commenters did not believe it was necessary to require written beneficiary

consent. Others asked that CMS devel op model beneficiary consent forms. Response: We understand the commenters’ concerns about adequate documentation, although this issue is not unique to CCM services . We believe the additional scope of service element for the EHR and electronic sharing of th e care plan and clinical summary record will create an electronic “footprint” that will fac ilitate documentation, including documentation of the minimum monthly amount of time spent in providing CCM services. Regarding beneficiary consent, we belie ve written beneficiary consent and its documentation in the medical record is necessary because we are requiri ng practices to share beneficiaries’ protected health in formation both within and outside of the billing practice in the course of furnishing CCM services and because be neficiaries will be required to pay coinsurance

on non-face-to-face services. We do not believe the content or nature of the required consent is so complex that we should develop model formats. If we believe changes to the scope of service elements are warranted in the future, we will propose them through notice and comment rulemaking taking the comments we receiv ed to date into consideration. In summary, we are finalizing our proposal for the CCM scope of service element for EHR technology as proposed, with the following modification. We are including as an element of the separately billable CCM service the use of, at a minimum, technology certified to the edition(s) of certification criteria that is acceptable for the EHR Incentive Programs as ofCMS-1612-FC 488

December 31 st of the calendar year prior to the PFS pa yment year (CCM certified technology), to meet the final core EHR capabilities (struc tured recording of demographics, problems, medications, medication allergies and the creation of a structured clinical summary record) and to fulfill all activities within the final scope of se rvice elements that reference a health or medical record. For CCM payment in CY 2015, this po licy will allow practitioners to use EHR technology certified to either the 2011 or 2014 edition( s) of certifica tion criteria. The final scope of service elements that refer to a health or medical record, and that must be fulfilled using the CCM certified technology, are summarized in Table 33 and include the following:

● A full list of problems, medications and medication allergies in the EHR must inform the care plan, care coordinati on and ongoing clinical care.

● Communication to and from home and community based providers regarding the patient’s psychosocial needs and functional deficits must be documented in the patient’s medical

record.

● Inform the beneficiary of the availability of CCM services and obtain his or her written agreement to have the services provide d, including authorizati on for the electronic

communication of his or her medical information with other treati ng providers. Document in the beneficiary’s medical record that all of the CCM services were explained and offered, and note the beneficiary’s decision to accept or decline these services.

● Provide the beneficiary a wr itten or electronic copy of the care plan and document in

the electronic medical record that the car e plan was provided to the beneficiary. We are finalizing our proposal regarding the electronic care plan scope of service element without modification. To satisfy this element, pr actitioners must at leas t electronically capture care plan information; make this information avai lable on a 24/7 basis to all practitioners withinCMS-1612-FC 489

the practice who are furnishing CCM services whose time counts towards the time requirement for the practice to bill the CCM code; and share ca re plan information elec tronically (other than by facsimile) as appropriate with other practitione rs and providers who ar e furnishing care to the beneficiary. We are not requiring practitioners to use a specif ic electronic solution to furnish the care plan element of the CCM service, only th at the method must be electronic and cannot

include facsimile transmission. Similarly, we are not requiring practitioners to use a specific tool or service to communicate clinical summaries in managing care transitions, as long as practitioners transmit the clinical summaries electronically, with th e exception of faxing which will not fulfill the requirement for exchange of a summary care reco rd. However practitioners must format their clinical summaries according to, at a minimum, the standard that is acceptable for the EHR Incentive Programs as of December 31 st of the calendar year preceding each PFS payment year.

We remind stakeholders that for all electronic sharing of benefi ciary information under our final CCM policies, HIPAA standards apply in th e usual manner. We summarize the final requirements for the CCM scope of service elem ents and billing requirements for CY 2015 and their relationship to the fina l EHR requirements in Table 33.CMS-1612-FC 490TABLE 33: Summary of Final CCM Scope of Service Elements and BillingRequirements for CY 2015CCM Scope of Service Element/Billing Requirement Certified EHRor Other Electronic TechnologyRequirementStructured recording of demographics, problems, medications,medication allergies, and the creation of a structured clinicalsummary record. A full list of problems, medications andmedication allergies in the EHR must inform the care plan, carecoordination and ongoingclinical care.Structured recording of demographics, problems,medications, medication allergies,and creation of structuredclinical summary records using CCM certified technology.Access to care management services 24/7 (providing thebeneficiary with a means to maketimely contact with health careproviders in the practice to address his or her urgent chronic careneeds regardless of the time ofday or day of the week).NoneContinuity of care with a designated practitioner or member of thecare team with whom the beneficiary is able to get successiveroutine appointments.NoneCare management for chronic conditions including systematicassessment of the beneficiary’s medical, functional, andpsychosocial needs; system-based approaches to ensure timelyreceipt of all recommended preventive care services; medicationreconciliation with review of adherence and potential interactions;and oversight of beneficiary self-management of medications.NoneCreation of a patient-centeredcare plan based on a physical,mental, cognitive, psychosocial, functional and environmental(re)assessment and an inventory of resources and supports; acomprehensive care plan for all health issues. Share the care planas appropriate with other practitioners and providers.Must at least electronically capture care plan information;make this information available on a 24/7 basis to allpractitioners within the practice whose time counts towardsthe time requirement for the practice to bill the CCM code;and share care plan information electronically (other than byfax) as appropriate with otherpractitioners and providers.Provide the beneficiary with a written or electronic copy of the careplan and document its provision inthe electronic medical record.Document provision of the care plan as required to thebeneficiary in the EHR using CCM certified technology.CMS-1612-FC 491CCM Scope of Service Element/Billing Requirement Certified EHRor Other Electronic TechnologyRequirementManagement of care transitions between and among health careproviders and settings, includingreferrals to other clinicians;follow-up after an emergency department visit; and follow-up afterdischarges from hospitals, skilled nursing facilitiesor other healthcare facilities.•Format clinical summaries according to CCMcertified technology.•Not required to use a specific tool or service toexchange/transmit clinical summaries, as long asthey are transmitted electronically (other than byfax).Coordination with home and community based clinical serviceproviders.Communication to and fromhome and community basedproviders regarding the patient’s psychosocial needs andfunctional deficits must bedocumented in the patient’smedical record using CCM certified technology.Enhanced opportunities for the beneficiary and any caregiver tocommunicate with the practitionerregarding the beneficiary’s carethrough not only telephone access,but also through the use ofsecure messaging, internet or other asynchronous non face-to-faceconsultation methods.NoneBeneficiary consent - Inform the beneficiary of the availability ofCCM services and obtain his or her written agreement to have theservices provided, including authorization for the electroniccommunication of his or her medical information with othertreating providers. Document inthe beneficiary’s medical recordthat all of the CCM services were explained and offered, and notethe beneficiary’s decision to accept or decline these services.Document the beneficiary’s written consent andauthorization in the EHR using CCM certified technology.Beneficiary consent - Inform the beneficiary of the right to stop theCCM services at any time (effective at the end of the calendarmonth) and the effect of a revocation of the agreement on CCMservices.NoneCMS-1612-FC 492CCM Scope of Service Element/Billing Requirement Certified EHRor Other Electronic TechnologyRequirementBeneficiary consent - Informthe beneficiary that only onepractitioner can furnish and be paid for these services during acalendar month.NoneCMS-1612-FC 493

4. Payment of CCM Services in CMS Models and Demonstrations As discussed in section II.G., several CMS models and demonstrations address payment for care management services. The Multi-pay er Advanced Primary Care Practice (MAPCP) Demonstration and the Comprehensive Primary Care (CPC) Initiative both include payments for care management services that closely overlap with the scope of service for the new chronic care management services code. In these two initiatives, primary care practices are receiving per beneficiary per month payments for care manageme nt services furnished to Medicare fee-forservice beneficiaries attri buted to their practices. We proposed that practitioners participating in one of these two models may not bill Medicare for CCM services furnished to any beneficiary attributed to the practice for purpos es of participating in one of th ese initiatives, as we believe the payment for CCM services would be a dupl icative payment for s ubstantially the same services for which payment is made through the per beneficiary per month payment. However, we proposed that these practitioners may bill Me dicare for CCM services furnished to eligible

beneficiaries who are not attributed to the practice for the purpose of the practice’s participation as part of one of these initi atives. As the Innovation Cent er implements new models or demonstrations that include payments for care ma nagement services, or as changes take place that affect existing models or demonstrations, we will address potential overlaps with the CCM service and seek to implement appropriate re imbursement policies. We solicited comments on this proposal. We also solicited comments on the extent to which these services may not actually be duplicative and, if so, how our reimbursement policy could be tailored to address those

situations.

We received several comments that either supported or did not oppose our proposed policy regarding the payment of CCM services in CMS models and demonstrations that also pay for care management services.CMS-1612-FC 494

The following is a summary of the other comme nts we received regarding our proposals on reimbursement policies. Comment: Two commenters requested that we reconsider our proposed policy to exclude demonstration practitioners from billing for CCM se rvices to ensure that these practitioners are not disadvantaged relative to t hose practitioners who do not part icipate in demonstrations or

models. Response: Our proposed policy does not ex clude practitioners participating in demonstrations or models from billing for CCM serv ices. To reiterate, practitioners participating in demonstrations or models may bill Medicare for CCM services for beneficiaries who are not attributed to the practices for purposes of par ticipating in either the MAPCP or CPC. For beneficiaries who are not attributed to the pr actice, no care management payment is made under the MAPCP or CPC models. If the beneficiary otherwise meets the criteria for CCM services, the practitioner may furnish and bill Medica re for CCM. However, Medicare will not pay practitioners participating in MAPCP or CPC for CCM services furnished to beneficiaries attributed to the practice for the purpose of the practice’s participation in either these models. We believe we have created a pathway to enable practitioners participatin g in CPC or MAPCP to bill Medicare for the CCM services, as not all benefi ciaries treated in a practice will be attributed to the practice. Comment: We received two comments expre ssing concern for confusion that might occur regarding the inte raction of CCM services and the CPC model. Response: We acknowledge that the Innovation Center will need to engage in extensive communications efforts with practi tioners participating in either CPC or MAPCP to inform them of our policies regarding billing for CCM services.

Comment: One individual commented that payment for CCM “should not beCMS-1612-FC 495

constrained” by the payment in a demonstration. The commenter also said, “The two payments are completely unrelated and are made for di fferent purposes to very different physician practices. Also, we do not believ e it is possible to know with cer tainty whether there is overlap

between a fee

‐ for

‐ service chronic care management payment and a payment for care

coordination in a demonstration.” Response: The proposed policy aims not to constrain practi tioners voluntarily participating in Innovation Center models and de monstrations, specificall y CPC and MAPCP, by allowing them to bill Medicare for CCM services furnished to beneficiaries for whom they are not receiving payments as part of these initiatives. We expect the practitioners participating in these initiatives will be eligible to bill the CCM service for some beneficiaries, as there is overlap between elements of the CCM service and the models. For example, the CPC model requires practitioners to use elec tronic health records that ha ve been certified by the National Coordinator for Health Information Technology, provide patients w ith 24/7 access to the practice, ensure continuity of care with a desi gnated practitioner or care team for each patient, provide care management that includes a system atic assessment of patient needs, use patientcentered care plans, and give enhanced opportuni ties for patient and caregiver communications. Similarly, the MAPCP demonstration is testing th e patient-centered medical home model, which focuses on care management, continuity of care, and care coordination. All practitioners, who are voluntarily participating in these initiativ es, receive quarterly re ports indicating which

beneficiaries have been attributed to their practices. After revi ewing and comparing the features

of the CPC and MAPCP models with the CCM service, we continue to be convinced that there is overlap. The CCM service pr ovides appropriate payment fo r care management and care

coordination furnished to beneficiaries with mu ltiple chronic conditions within the current feefor-service Medicare program, wh ile Innovation Center models and demonstrations testCMS-1612-FC 496

alternative payment methods that promote less reliance on a fee-for-service funding stream and support primary care delivery transformation at th e practice level to identify potential future alternative approaches to payment. In response to these comments, we will enga ge in extensive communications explaining to practices participating in CMMI models and demonstrations, specifically the CPC and MAPCP initiatives, the policies re lated to care management paymen ts under these initiatives and

the CCM service. We continue to believe the payment for CCM services would be a duplicative payment for substantially the same services incl uded in the per beneficiary per month payment under the CPC and MAPCP models. Therefore, we are finalizing our proposed policy that CMS will not pay practitioners participating in one of these two initiatives for CCM services furnished to any beneficiary attributed by the initiative to the practice. These practitioners may bill Medicare for CCM services furnished to eligible beneficiaries who are not attributed by the initiative to the practice. As the Innovation Center implements new models or demonstrations that include payments for care management services , or as changes take place that affect existing models or demonstrations, we will address poten tial overlaps with the CCM service and seek to implement appropriate payment policies.CMS-1612-FC 497

I. Outpatient Therapy Caps for CY 2015 Section 1833(g) of the Act requires application of annual, per beneficiary, limitations on the amount of expenses that can be considered as incurred expenses for outpatient therapy services under Medicare Part B, commonly referred to as “thera py caps.” There is one therapy cap for outpatient occupational therapy (OT) se rvices and another separate therapy cap for physical therapy (PT) and speech-language pathology (SLP) services combined. The therapy caps apply to outpa tient therapy services furnishe d in all settings, including the once-exempt outpatient hospital setting (e ffective October 1, 2012) and critical access hospitals (effective January 1, 2014). The therapy cap amounts under section 1833(g) of the Act are updated each year based on the Medicare Economic Index (MEI). Spec ifically, the annual cap s are calculated by updating the previous year’s cap by the MEI for the upcoming calendar year and rounding to the nearest $10.00. Increasing the CY 2014 ther apy cap of $1,920 by the CY 2015 MEI of 0.8 percent and rounding to the nearest $10.00 resu lts in a CY 2015 therapy cap amount of $1,940. An exceptions process for the therapy caps has been in effect since January 1, 2006. Originally required by section 5107 of the Deficit Reduction Act of 2005 (DRA), which amended section 1833(g)(5) of th e Act, the exceptions process for the therapy caps has been extended multiple times through subsequent le gislation (MIEA-TRHCA, MMSEA, MIPPA, the Affordable Care Act, MMEA, TPTCCA, MCTR JCA, ATRA and PAMA). The Agency’s current authority to provide an exceptions process for ther apy caps expires on March 31, 2015. After expenses incurred for the beneficiary’s ou tpatient therapy servic es for the year have exceeded one or both of the therapy caps, therap y suppliers and providers use the KX modifier on claims for subsequent services to request an exception to the therapy caps. By use of the KX modifier, the therapist is attesting that the services above the therapy caps are reasonable andCMS-1612-FC 498

necessary and that there is documentation of medical necessi ty for the services in the beneficiary’s medical record. Under section 1833(g)(5)(C) of the Act, we are required to apply a manual medical review process to therapy claims when a benefi ciary’s incurred expenses for outpatient therapy

services exceed a threshold am ount of $3,700. There are two sepa rate thresholds of $3,700, just as there are two separate therapy caps, one for OT services and one for PT and SLP services combined, and incurred expenses are counted towa rds the thresholds in the same manner as the caps. The statutorily required manual medical review expires March 31, 2015, consistent with the expiration of the Agency’s authority to provi de an exceptions process for the therapy caps. For information on the manual medical review process, go to www.cms.gov/Research-StatisticsData-and-Systems/Monitoring-Programs /Medical-Review/TherapyCap.html.CMS-1612-FC 499

J. Definition of Colorectal Cancer Screening Tests As discussed in the proposed rule (79 FR 40368), section 1861(pp) of the Act defines “colorectal cancer screening tests” and, under section 1861(pp)(1)(C), a “screening colonoscopy” is one of the recognized procedures. Among ot her things, section 1861(p p)(1)(D) of the Act authorizes the Secretary to modi fy the tests and procedures c overed under this subsection, “with such frequency and payment limits, as the Secr etary determines appropr iate,” in consultation with appropriate organizations. The current definition of “colorect al cancer screening tests” at §410.37(a)(1) includes “screening colonoscopies.” Until recently, the prevailing practice for screening colonoscopies has been moderate se dation provided intravenously by the endoscopist, without resort to separate ly provided anesthesia. 3 Based on this prevailing practice, payment for moderate sedation has accordingly been bundled into the payment for the colorectal cancer screening tests, (for example, G0104, G0105). Fo r these procedures, because moderate sedation is bundled into the payment, the same physic ian cannot also report a sedation code. An

anesthesia service can be bi lled by a second physician. However, a recent study in The Journal of the American Medical Association (JAMA) cited an increase in the percentage of colonos copies and upper endoscopy procedures furnished using an anesthesia professional, from 13.5 pe rcent in 2003 to 30.2 percent in 2009 within the Medicare population, with a similar increas e in the commercially-insured population. 4 A 2010 study projected that the percenta ge of this class of proce dures involving an anesthesia professional would grow to 53.4 percent by 2015. 5 These studies suggest that the prevailing practice for endoscopies in gene ral and screening colonoscopies in particular is undergoing a

3 Faulx, A. L. et al. (2005). The changing landscape of practice patter ns regarding unsedated colonoscopy and propofol use: A national web survey. Gastrointestinal Endoscopy, 62. 9-15. 4 Liu H, Waxman DA, Main R, Mattke S. U tilization of Anesthesia Se rvices during Outpatient E ndoscopies and Colonoscopies and Associated Spending in 2003-2009. (2012). JAMA , 307(11):1178-1184. 5 Inadomi, J. M. et al. (2010). Projected in creased growth rate of anes thesia professional–delivered sedation for colonoscopy and EGD in the United States: 2009 to 2015. Gastrointestinal Endoscopy, 72, 580-586.CMS-1612-FC 500

transition, and that anesthesia separately provide d by an anesthesia professional is becoming the prevalent practice. In preparation for the propose d rule, we reviewed these studies and analyzed

Medicare claims data. We saw the same tr end in screening colonoscopies for Medicare beneficiaries with 53 percent of the screening co lonoscopies for Medicare claims submitted in 2013 had a separate anesthesia claim reported. In light of these developments, we expresse d our concern in the proposed rule that the mere reference to “screening colonoscopies” in the definition of “colorectal cancer screening tests” has become inadequate. Indeed, we we re convinced that the growing prevalence of separately provided anesthesia se rvices in conjunction with sc reening colonoscopies reflects a change in practice patterns. Therefore, cons istent with the authority delegated by section 1861(pp)(1)(D) of the Act, we proposed to revise the definition of “colo rectal cancer screening tests” to adequately reflect these new patterns. Specifically, we proposed to revise the definition of “colorectal cancer screening test s” at §410.37(a)(1)(iii) to include anesthesia that is separately furnished in conjunction with scre ening colonoscopies (79 FR 40369). We also stated that our proposal to revise the definition of “colorectal cancer screening

tests” in this manner would further reduce our be neficiaries’ cost-sharing obligations under Part B. Screening colonoscopies have been recomm ended with a grade of A by the United States Preventive Services Task Force (USPSTF) and §410.152(l)(5) provides that Medicare Part B pays 100 percent of the Medica re payment amount established under the PFS for colorectal cancer screening tests except for barium en emas (which do not have a grade A or B recommendation from the USPSTF). This regula tion is based on section 1833(a)(1) of the Act, as amended by section 4104 of the Affordable Ca re Act, which requires 100 percent Medicare payment of the fee schedule amount for those “pre ventive services” that are appropriate for the individual and are recommended with a grade of A or B by the USPSTF. Section 4104 of theCMS-1612-FC 501

Affordable Care Act amended se ction 1833(a)(1) of the Act to effectively waive any Part B

coinsurance that would otherwis e apply for certain recommended preventive services, including screening colonoscopies For additional discussion of the impact of section 4104 of the Affordable Care Act, and our prior rulema king based on this provision see the CY 2011 PFS final rule with comment period (75 FR 73412 through 73431). We also noted that under §410.160(b)(7) colorectal cancer scre ening tests are not subject to the Part B annual deductible

and do not count toward m eeting that deductible. In implementing the amendments made by s ection 4104 of the Affordable Care Act, we did not provide at that time for waiving the Part B deductible and coinsurance for covered anesthesia services separately furnished in conjunction with sc reening colonoscopies. At that time, we believed that our payment for the sc reening colonoscopy, which included payment for moderate sedation services, reflected the typi cal screening colonoscopy. Under the current regulations, Medicare beneficiarie s who receive anesthesia from a di fferent professional than the one furnishing the screening colonoscopy would be incurring costs for the coinsurance and

deductible under Part B for those se parate services. With the cha nges in the standard of care and shifting practice patterns toward increased use of anesthesia in conjunction with screening colonoscopy, beneficiaries who rece ive covered anesthesia services from a different professional than the one furnishing the colonoscopy would in cur costs for any coin surance and any unmet part of the deductible for this component of the service. However, our proposed revision to the

definition of “colorectal cancer screening tests” would lead to Medicare paying 100 percent of the fee schedule amounts for screening colonosc opies, including any por tion attributable to anesthesia services furnished by a separate pr actitioner in conjunction with such tests, under §410.152(l)(5). Similarly, this revision would also mean that expenses incurred for a screening colonoscopy, and the anesthesia services furnishe d in conjunction with such tests, will not beCMS-1612-FC 502

subject to the Part B deductible and will not count toward meeting that deductible under §410.160(b)(7). We believe the proposal encourag es more beneficiaries to obtain a screening colonoscopy, which is consistent with the intent of the stat utory provision to waive Medicare cost-sharing for certain recommended preventive services, and is consiste nt with the authority delegated to the Secretary in sec tion 1861(pp)(1)(D) of the Act. In light of the changing practice patterns for screening colonoscopies, continuing to require Medicare beneficiaries to bear the deduc tible and coinsurance expenses for separately

billed anesthesia services fu rnished and covered by Medicare in conjunction with screening colonoscopies could become a signi ficant barrier to thes e essential preventive services. As we noted when we implemented the provisions of the Affordable Care Act waiving the Part B deductible and coinsurance for these preventive services, the goal of th ese provisions was to

eliminate financial barriers so that benefici aries would not be deterred from receiving them (75 FR 73412). Therefore, we proposed to exer cise our authority under section 1861(pp)(1)(D)

of the Act to revise the definition of colorectal cancer screening tests to encourage beneficiaries to seek these services by extending the waiver of coinsurance and deductib le to anesthesia or sedation services furnished in conjun ction with a screening colonoscopy. We noted in the proposed rule (79 FR 40370) that, in implementing these proposed revisions to the regulations, it would be necessary to establish a modifier for use when billing the

relevant anesthesia codes for services that are furnished in conjunction with a screening colonoscopy, and thus, qualify for the waiver of the Part B deductible and coinsurance. Therefore, we noted that we would provide appropriate and timely information on this new modifier and its proper use so that physicians will be able to bill correctly for these services when the revised regulations become effective. We also noted that the valuation of colonoscopy codes, which include moderate sedation, would be subject to the same proposed review as otherCMS-1612-FC 503

codes that include moderate sedation, as discus sed in section II.B.6 of this final rule with comment period. The following is a summary of the comments received on this proposal. Comment: The majority of commenters st rongly supported finaliz ing our proposal to

revise the definition of “colorectal cancer screening tests” at §410.37( a)(1)(iii) to include anesthesia that is furnished in conjunction with screening colonosc opies. However, one commenter expressed concern abou t the timing of the proposal, and specifically that it leaves little time for implementation in CY 2015. Ther efore, the commenter recommended that the proposal should be considered for implementation in CY 2016. Response: We appreciate th e support for our proposal and are finalizing it as proposed. Specifically, we are revising the definition of “colorectal cancer screening tests” at §410.37(a)(1)(iii) to include anesth esia that is furnished in conjunction with screening colonoscopies. We disagree with the recommen dation to delay implem entation until CY 2016. The proposed implementation on January 1 st following the finalization of the policy in the final rule follows the usual PFS schedule for implementation of payment changes. We are not aware of a reason for deviating from the usual sche dule for this policy. Therefore, we are implementing this final rule, effective January 1, 2015. Comment: Many commenters urged us to exte nd our proposed revision, by identifying a way under our existing authority to redefine colorectal cancer sc reening to include screening colonoscopy with removal of polyp, abnormal grow th, or tissue during the screening encounter. Commenters stated that there is already subs tantial confusion among beneficiaries about why colonoscopy with polyp removal requires payment of coinsurance, while colonoscopy without polyp removal does not. The commenters maintained that our proposal to in clude anesthesia that is separately furnished in conj unction with screening colonosc opies within th e definition ofCMS-1612-FC 504

screening colonoscopy would only cause additiona l confusion, unless screening colonoscopies with removal of polyp, along with any anesthesia separately furn ished in conjunction with such procedures, are also included with in the definition. Because our proposal rule did not seek to make changes to our policies with respect to diagnostic colonoscopies, the commenters were concerned that, beneficiaries may be liable for part B coinsurance for both diagnostic colonoscopy and any anesthesia furnished in conjunction with the colonoscopy when a polyp is

removed. Commenters also stated that exte nding our proposal in this manner would be good public policy, because it would redu ce the disincentives to this essential preventive service posed by possible liability for coinsurance if a polyp is discovered and removed during a screening colonoscopy. The commenters also emphasized th at further extending the definition in this way would remove an inconsistency between Medicar e policy and the new requirements for private health plans that prohibit the imposition of co st sharing when a polyp is removed under the

Affordable Care Act. Response: We understand the commenters ’ concerns, however, we do not have the authority to adopt the recomme nded revisions by regulation. Our authority is limited by the language of the Medicare Act. Specifically, section 1834(d)(3)(D) of the Act states that, “[i]f during the course of such a screening colonoscopy, a lesion or growth is detected which results in a biopsy or removal of the lesion or growth, payment under this part shall no t be made for the screening co lonoscopy but shall be made for the procedure classified as a colonoscopy with su ch biopsy or removal.” As a result of this statutory provision, when an anticipated scre ening colonoscopy ends up involving a biopsy or polyp removal, Medicare cannot pay for this proc edure as a screening colonoscopy. In these circumstances, Medicare pays 80 percent of the diagnostic colonoscopy procedure and the beneficiary is responsible for pa ying Part B coinsurance. Under the statute, when a polyp orCMS-1612-FC 505

other growth is removed, beneficiaries are respon sible for Part B coinsurance for the diagnostic colonoscopy, and similarly, any Part B coin surance for any covered anesthesia. Comment: Commenters stated that the pr oposal was not clear on how the deductible will

be treated in the case of anesthesia services when a polyp or other tissue is removed during a screening colonoscopy. Response: Section 1833(b)(1) of the Ac t, as amended by section 4104(c) of the Affordable Care Act, waives the Part B deductib le for “colorectal screen ing tests regardless of

the code billed for the establishm ent of a diagnosis as a result of the test, or the removal of tissue or other matter or other procedur e that is furnished in connection with, as a result of, and in the same clinical encounter as a screening test.” We explained this provision in the CY 2011 PFS final rule with comment period (75 FR 73431). We apply this policy to any surgical service furnished on the same date as a planned color ectal cancer screening test . Our regulations at §410.152(l)(5) already require Medicare Part B to pay 100 percent of th e Medicare payment

amount for colorectal cancer scr eening tests (excluding barium enema). The statutory waiver of deductible will apply to the anesthesia services fu rnished in conjunction with a colorectal cancer screening test even when a pol yp or other tissue is removed du ring a colonoscopy. As in the case of the physician furnishing the colonoscopy service, the anesthesia professional reporting the anesthesia in conjunction with the colonoscopy where a polyp is removed would also report

the PT modifier. Comment: Commenters urged CMS to provi de guidance as to whether CPT code 00810 (Anesthesia for lower intestinal endoscopic procedures, endoscope introduced distal to duodenum) would be billed with a modifier to in dicate whether the procedure was screening or

not.CMS-1612-FC 506

Response: Effective January 1, 2015, bene ficiary coinsurance and deductible do not apply to the following anesthesia claim lines bille d when furnished in conjunction with screening colonoscopy services and billed with the appropriate modifier (33): 00810 (Anesthesia for lower intestinal endoscopic procedur es, endoscope introduced distal to duodenum). Anesthesia professionals who furnish a separately payabl e anesthesia service in conjunction with a colorectal cancer screening test should incl ude the 33 modifier on the claim line with the

anesthesia service. As noted above in situations that begin as a colorect al cancer screening test,

but for which another service such as colonosco py with polyp removal is actually furnished, the anesthesia professional should repor t a PT modifier on the claim line rather than the 33 modifier.

Comment: Several commenters recommende d that we not only finalize the revised

definition of “colorectal cancer scr eening tests,” but also take step s to ensure that our Medicare Administrative Contractors (MACs) are not inappropriately taking ac tions that have the effect of nullifying some or much of the intended benef it of this policy change. Specifically, these commenters requested that we prevent the current efforts by one or more Medicare contractors to limit Medicare coverage for anesthesia services furnished during a screening colonoscopy by an anesthesia professional. Anot her commenter urged us to clar ify that this proposed expanded definition of colorectal cancer screening to includ e anesthesia services shou ld not be construed to override or preempt existing or planned coverage policies on the appropriate use of these services by MACs. Response: This final rule with comment period establishes na tional policy and takes precedence over any local coverage policy that limits Medicare coverage for anesthesia services furnished during a screening colonosc opy by an anesthesia professional.CMS-1612-FC 507

K. Payment of Secondary Interpretation of Images In general, Medicare makes one payment for the professional component of an imaging service for each technical component (TC) service that is furn ished. Under “unusual circumstances,” physicians can bill for a sec ondary interpretation using modifier -77, for instance, when an emergency room physician conducts an x-ray, provides an interpretation, identified a questionable findi ng, and subsequently requests a second interpretation from a radiologist to inform treatment decisions. In all cases, a “profe ssional component” (PC) interpretation service should only be billed for a full interpreta tion and report, rather than a “review,” which is paid for as part of an E/M payment. In recent years, technological advances such as the integration of picture and archiving communications systems across health systems, gr owth in image sharing networks and healthinformation exchange platforms through which providers can share images, and consumermediated exchange of images, have greatly in creased physicians’ access to existing diagnosticquality radiology images. Accessing and utilizin g these images to inform the diagnosis and record an interpretation in the medical record may allow physicians to avoid ordering duplicative

tests. We solicited comments on the appropriatene ss of more routine billing for secondary interpretations, although we did not propose to make any changes to th e treatment of these

services in 2015. We wanted to determine whether there were an expanded set of circumstances under which more routine Medicare payment for a second PC for radiology services would be appropriate, and whether such a policy would be likely to reduce the in cidence of duplicative advanced imaging studies. To achieve that goal, we solicited comments on the following: the circumstances under which physicians are currently conducting sec ondary interpretations and whether they areCMS-1612-FC 508

seeking payment for these interpretations; whether more routine payment for secondary interpretations should be restrict ed to certain high-cost advanc ed diagnostic imaging services; considerations for valuing seconda ry interpretation services; th e settings in which secondary interpretations chiefly occur; and considerations for operationalizing more routine payment of secondary interpretations in a manner that would minimize burden on providers and others. Comment: Many commenters responded to our secondary interpreta tion solicitation. In addition to comments on the merits of the pr oposals, commenters also provided helpful information about how to implement this polic y. Commenters offered diverse opinions on the time period for which an existing image woul d be pertinent in support of a secondary interpretation. Most commenters were in agreement that cost savings would be derived from the implementation of a secondary in terpretation policy but there was no consensus as to the amount of such savings. Moreover, many commenters poi nted out that they were already furnishing secondary interpretations and w ould appreciate adoption of a po licy that would allow them to receive payment for these services. Response: We thank all the commenters fo r their input. Any changes to our current policy on allowing physicians to more routinely bill for secondary interpretations of images will be addressed in future rulemaking.CMS-1612-FC 509

L. Conditions Regarding Permissible Practice Types for Therapists in Private Practice Section 1861(p) of the Act defines outpatient therapy services to in clude physical therapy (PT), occupational therapy (OT), and speech-lan guage pathology (SLP) services furnished by qualified occupational therapists, ph ysical therapists, and speech-l anguage pathologists in their

offices and in the homes of beneficiaries. The regulations at §§410.59(c), 410.60(c), and 410.62(c) set forth special provisions for services furnished by therapists in private practice, including basic qualifica tions necessary to qualify as a supplier of OT, PT, and SLP services, respectively. As part of these basic qualif ications, the current re gulatory language includes descriptions of the various pract ice types for therapists’ private practices. Based on our review of these three sections of our regulations, we b ecame concerned that the language is not as clear as it could be – especially with regard to the re levance of whether a practi ce is incorporated. The regulations appear to make dis tinctions between unincorporated and incorporated practices, and some practice types are listed twice. Accordi ngly, we proposed changes to the regulatory language to remove unnecessary distinctions and redundancies within the re gulations for OT, PT, and SLP. We noted that these changes are for cl arification only, and do not reflect any change in our current policy. To consistently specify the permissible prac tice types (a solo pract ice, partnership, or group practice; or as an employee of one of these) for suppliers of outpatient therapy services in private practice (specifically for occupational th erapists, physical therap ists and speech-language pathologists), we proposed to replace the regu latory text at §410.59(c )(1)(ii)(A) th rough (E), §410.60(c)(1)(ii)(A) through (E), and §410.62(c)(1)( ii)(A) through (E) and to replace it with language listing the permissibl e practice types without limitations for incorporated or unincorporated.CMS-1612-FC 510

Comment: We received comments from two therapist membership associations supporting our proposed changes to the regulations . Both commenters agree that the proposed language more consistently and accurately reflects the permissible practice types for therapists in private practice. Another commenter representing a membership association of rehabilitation physicians told us that, rather than clar ifying or simplifying the existing regulations, the proposed language is more ambiguous. The commenter urged us to clarify that our proposed language would continue to allow therapists in private practi ce to be employed by physician groups as specified in current provisions. Response: We appreciate the commenters’ supp ort for our proposal. With regard to the commenter that expressed concern about the clarit y of the proposed regulation text as to whether therapists in private practice can be empl oyed by a physician group, we acknowledge that the current regulation explicitly permits that practice arrangement. However, we believe that our proposed language describing the pr actice arrangements of privat e practice therapists–a solo practice, partnership, or group prac tice; or as an employee of one of these–clearly continues to permit therapists to practice as an employee of a physician group, whether or not incorporated. We believe the reference in the proposed regulati on to “group practice” is sufficiently broad to encompass a physician group, and thus permits ther apists in private practice to practice as employees of these groups, where permissible under state law. Therefore, we are finalizi ng our proposed changes to the regulations for permissible practice types for therapists in privat e practice at §410.59(c)(1 )(ii)(A) through (E), §410.60(c)(1)(ii)(A) through (E), an d §410.62(c)(1)(ii)(A) through(E).CMS-1612-FC 511

M. Payments for Practitioners Ma naging Patients on Home Dialysis

In the CY 2005 PFS final rule with comme nt period (69 FR 66357 through 66359), we

established criteria for furnishi ng outpatient per diem ESRD-rela ted services in partial month scenarios. We specified that use of per diem ESRD-related services is intended to accommodate unusual circumstances when the outpatient ESRD-re lated services would not be paid for under the monthly capitation payment (MCP), and that us e of the per diem services is limited to the

circumstances listed below.

• Transient patients – Patients traveling away from home (less than full month);

• Home dialysis patients (less than full month);

• Partial month where there were one or more face-to-face visits without the comprehensive visit and either the patient was hospitalized before a complete assessment was furnished, dialysis stopped due to death, or the patient received a kidney transplant.

• Patients who have a permanent change in their MCP physician during the month. Additionally, we provided billing guidelines fo r partial month scenarios in the Medicare claims processing manual, publication 100-04, chapter 8, section 140.2.1. For center-based patients, we specified that if the MCP practitioner furnishes a co mplete assessment of the ESRD beneficiary, the MCP practitioner sh ould bill for the full MCP service that reflects the number of visits furnished during the month. However, we di d not extend this policy to home dialysis (less than a full month) because the home dialysis MCP service did not include a specific frequency of required patient visits. In other words, unlike the ESRD MCP service for center-based patients, a visit was not required for the home dialysis MCP service as a condition of payment.

In the CY 2011 PFS final rule with comme nt period (75 FR 73295 through 73296), we changed our policy for the home dialysis MCP service to require the MCP practitioner to furnish at least one face-to-face patient visit per month as a condition of payment. However, weCMS-1612-FC 512

inadvertently did not modify our billing guidelines for home dialys is (less than a full month) to be consistent with partial month scenarios for center-based dialysis patients. As discussed in the CY 2015 proposed rule (79 FR 40371) stakeholders have recently brought this inconsistency to our attention. After reviewing this issue, we proposed to allow the MCP physician or practitioner to bill for the ag e appropriate home dialysis MCP service (as described by HCPCS codes 90963 through 90966) for the home dialysis (l ess than a full month) scenario if the MCP practitioner furnishes a complete monthly assessme nt of the ESRD beneficiary and at least one face-to-face patient visit. For example, if a home dialysis patient was hospitalized during the month and at least one face-to-face outpatient visit and complete monthly assessment was furnished, the MCP practitioner should bill for the full home dialysis MCP service. We explained that this proposed cha nge to home dialysis (less th an a full month) would provide consistency with our policy for partial month s cenarios pertaining to pa tients dialyzing in a dialysis center. We also stated that if this proposal is adopted, we w ould modify the Medicare Claims Processing Manual to refl ect the revised billing guidelines for home dialysis in the less

than a full month scenario. A summary of the comments on this proposal and our response is provided below.

Comment: Several stakeholders strongly supported our propos ed change for practitioners managing patients on home dialysis. Specifically , the commenters stated that the proposed change in policy for the home dialysis MCP service is nece ssary to appropriately align practitioner payment for managing home dialysis patients with center based patients, and encouraged us to finalize the change in polic y as proposed. One commen ter explained that the current policy for home dialysis less than a full month requires the nephrol ogist to “separate out the time their home dialysis patients spend in the hospital and bill for outpatient services at a daily rate instead of the full capitated payment. ” The same commenter stated that “properlyCMS-1612-FC 513

aligning physician payments for managing home di alysis patients (with managing center based dialysis patients) may enable more patients to co nsider dialyzing at home, when appropriate.” Response: We agree with the commenters and will finalize our proposed policy change for home dialysis. We will allo w the MCP practitioner to bill fo r the home dialysis MCP service for the home dialysis (less than a full month) scenario if the MCP practitioner furnishes a complete monthly assessment of the ESRD benefi ciary and at least one fa ce-to-face patient visit during the month.CMS-1612-FC 514

N. Allowed Expenditures for Physicians' Se rvices and the Sustainable Growth Rate 1. Medicare Sustainable Growth Rate (SGR) The SGR is an annual growth ra te that applies to physicians’ services paid by Medicare. The use of the SGR is intended to control gr owth in aggregate Medi care expenditures for physicians’ services. Payments for services are not withheld if the percentage increase in actual expenditures exceeds the SGR. Rather, the PFS upda te, as specified in section 1848(d)(4) of the Act, is adjusted based on a comparison of allo wed expenditures (determined using the SGR) and actual expenditures. If actual expenditures exc eed allowed expenditures, the update is reduced. If actual expenditures are le ss than allowed expenditures, the update is increased. Section 1848(f)(2) of the Act sp ecifies that the SGR for a year (beginning with CY 2001) is equal to the product of the following four factors: (1) The estimated change in fees for physicians’ services; (2) The estimated change in the av erage number of Medicare fee-for-service beneficiaries; (3) The estimated projected growth in re al Gross Domestic Product per capita; and (4) The estimated change in expenditures due to changes in st atute or regulations. In general, section 1848(f)(3) of the Act requires us to determine the SGRs for 3 different time periods, using the best data available as of September 1 of each year. Under section 1848(f)(3) of the Act, (beginning with the FY and CY 2000 SGRs) the SGR is estimated and subsequently revised twice based on later data. (The Act also provides for adjustments to be made to the SGRs for FY 1998 and FY 1999. See the February 28, 2003 Federal Register (68 FR 9567) for a discussion of these SGRs). U nder section 1848(f)(3)(C)(i i) of the Act, there

are no further revisions to the SGR once it has been estimated and subsequently revised in each of the 2 years following the preliminary estimate . In this final rule with comment, we areCMS-1612-FC 515

making our preliminary estimate of the CY 2015 SGR, a revision to the CY 2014 SGR, and our

final revision to the CY 2013 SGR. a. Physicians’ Services Section 1848(f)(4)(A) of the Ac t defines the scope of physicians’ services covered by the

SGR. The statute indicates that “the term ‘physicians’ services’ includes other items and services (such as clinical di agnostic laboratory tests and radi ology services), specified by the Secretary, that are commonly perf ormed or furnished by a physicia n or in a physician’s office,

but does not include services furnished to a Medicare+Choice plan enrollee.” We published a definition of physicians’ services for use in the SGR in the November 1, 2001 Federal Register (66 FR 55316). We defined physicians’ services to include many of the medical and other health services list ed in section 1861(s) of the Act. Since that time, the statute has been amended to add new Me dicare benefits. As the statute changed, we modified the definition of physicians’ services for the SGR to include the additional benefits

added to the statute that meet the crite ria specified in sec tion 1848(f)(4)(A). As discussed in the CY 2010 PFS final rule with comment period (74 FR 61961), the statute provides the Secretary with clear disc retion to decide whethe r physician-administered drugs should be included or excluded from the definition of “physicians’ services.” Exercising this discretion, we removed physician-administer ed drugs from the definition of physicians’ services in section 1848(f)(4)(A) of the Act for purposes of computing the SGR and the levels of allowed expenditures and actual expenditures beginning with CY 2010, and for all subsequent years. Furthermore, in order to effectuate fu lly the Secretary’s policy decision to remove drugs from the definition of physicians’ services, we removed physician-administered drugs from the

calculation of allowed a nd actual expenditures for all prior years.CMS-1612-FC 516

Thus, for purposes of determining allowed expe nditures, actual expend itures for all years, and SGRs beginning with CY 2010 and for all subse quent years, we specified that physicians’

services include the follo wing medical and other health services if bills for the items and services are processed and paid by Medi care carriers (and those paid through intermediaries where specified) or the equivalent services proce ssed by the Medicare Admini strative Contractors:

● Physicians’ services.

● Services and supplies furnished incident to physicians’ serv ices, except for the expenditures for “drugs and biologicals which ar e not usually self-admin istered by the patient.”

● Outpatient physical therapy services a nd outpatient occupational therapy services,

● Services of PAs, certifi ed registered nurse anesthet ists, certified nurse midwives, clinical psychologists, clinical so cial workers, nurse practitioners , and certified nurse specialists.

● Screening tests for prostate cancer, colorectal cancer, and glaucoma.

● Screening mammography, screening pap smears, and screening pelvic exams.

● Diabetes outpatient self-manag ement training (DSMT) services.

● Medical Nutrition Therapy (MNT) services.

● Diagnostic x-ray tests, di agnostic laboratory tests, and ot her diagnostic tests (including outpatient diagnostic laboratory test s paid through in termediaries).

● X-ray, radium, and radioactive isotope therapy.

● Surgical dressings, splints , casts, and other devices used for the reduction of fractures

and dislocations.

● Bone mass measurements.

● An initial preventive physical exam.

● Cardiovascular sc reening blood tests.

● Diabetes screening tests.CMS-1612-FC 517

● Telehealth services.

● Physician work and resources to establish and document the need for a power mobility

device.

● Additional prev entive services.

● Pulmonary rehabilitation.

● Cardiac rehabilitation.

● Intensive cardi ac rehabilitation.

● Kidney disease education (KDE) services.

● Personalized preven tion plan services b. Preliminary Estimate of the SGR for 2015

We first estimated the CY 2015 SGR in Marc h 2014, and we made the estimate available

to the MedPAC and on our website. Table 34 shows the March 2014 estimate and our current

estimates of the factors included in the 2015 SG R. Our March 2014 estimate of the SGR was - 3.6 percent. Our current estimate of the 2015 SG R is -13.7 percent. The majority of the

difference between the March estimate and ou r current estimate of the CY 2015 SGR is explained by adjustments to refl ect intervening legislative changes that occurred after our March estimate was prepared. Subsequent to the displa y of the March 2014 estimate, section 101 of the Protecting Access to Medicare Act (PAMA) of 2014 continued a 0.5 percent update to the PFS conversion factor from April 1, 2014, through December 31, 2014 (relative to the 2013 conversion factor), in place of the 24.1 percen t reduction that would ha ve occurred under the SGR system on April 1, 2014. In addition, secti on 101 of PAMA also provides for a 0.0 percent update for services furnished on or afte r January 1, 2015, through March 31, 2015. While PAMA averted the large reduction in PFS rates scheduled to occur on April 1, 2014, there will be a large reduction in PFS rates on April 1, 2015, as a re sult of the expiration of the temporaryCMS-1612-FC 518

0.0 percent update. . The law and regulation factor of the curren t estimate of the SGR is now a much larger reduction than previously estimated to account for the current law reduction in PFS rates scheduled to occur on April 1, 2015. We will provide more detail on the change in each of

these factors below.

TABLE 34: CY 2015 SGR Calculations Statutory Factors March Estimate Current Estimate Fees 1.1 percent (1.011) 0.7 percent (1.007) Enrollment 4.0 percent (1.040) 3.9 percent (1.039) Real Per Capita GDP 0.8 percent (1.008) 0.7 percent (1.007) Law and Regulation -9.0 percent (0.910) -18.1 percent (0.819) Total -3.6 percent (0.964) -13.7 percent (0.863) Note: Consistent with section 1848(f)(2) of the Ac t, the statutory factors are multiplied, not added, to produce the total (that is, 1.007 x 1.039 x 1.007 x 0.819 = 0.863). A more detailed explanation of each figure is provided in section II.N.1.e. of this final rule with comment period.

c. Revised Sustainable Gr owth Rate for CY 2014

Our current estimate of the CY 2014 SGR is -0.8 percent. Table 35 shows our preliminary estimate of the CY 2014 SGR, whic h was published in the CY 2014 PFS final rule with comment period, and our current estimate. The majority of the difference between the preliminary estimate and our current estimate of the CY 2014 SGR is explained by adjustments to reflect intervening legisla tive changes that have occurred since publication of the CY 2014 PFS final rule with comment period. The PFS update reduction that would have occurred on April 1, 2014 was averted by PAMA, which has result ed in a much higher legislative factor than our estimate of the 2014 SGR in CY 2014 PFS final rule with comment period. We will provide more detail on the change in each of these factors below.CMS-1612-FC 519

TABLE 35: CY 2014 SGR Calculation Statutory Factors Estimate from CY 2014 Final Rule Current Estimate Fees 0.6 percent (1.006) 0.7 Percent (1.007) Enrollment 2.2 percent (1.022) 0.2 Percent (1.002) Real Per Capita GDP 0.8 percent (1.008) 0.7 Percent (1.007) Law and Regulation -19.6 percent (0.804) -2.4 Percent (0.976) Total -16.7 percent (0.833) -0.8 Percent (0.992) Note: Consistent with section 1848(f)(2) of the Act, th e statutory factors are multiplied, not added, to produce the total (that is, 1.007 x 1.002 x 1.007 x 0.976 = 0.992). A more detailed e xplanation of each figure is provided in section II.N.1.e. of this final rule with comment period.

d. Final Sustainable Growth Rate for CY 2013 The SGR for CY 2013 is 1.3 percent. Table 36 shows our preliminary estimate of the CY 2013

SGR from the CY 2013 PFS final rule with comment period, our revised estimate from the CY 2014 PFS final rule with comment period, and the final figur es determined using the best available data as of September 1, 2014. We will provide more detail on the change in each of these factors below.

TABLE 36: CY 2013 SGR Calculation

Statutory Factors Estimate from CY 2013 Final Rule Estimate from CY 2014 Final Rule Final Fees 0.3 percent (1.003) 0.4 percent (1.004) 0.4 Percent (1.004) Enrollment 3.6 percent (1.036) 1.0 percent (1.010) 0.5 Percent (1.005) Real Per Capita GDP 0.7 percent (1.007) 0.9 percent (1.009) 0.9 Percent (1.009) Law and Regulation -23.3 percent (0.767) -. 05 percent (.995) -0.5 Percent (0.995) Total -19.7 percent (0.803 1.8 percent (1.018) 1.3 Percent (1.013) Note: Consistent with section 1848(f)(2) of the Act, th e statutory factors are multiplied, not added, to produce the total (that is, 1.004 x 1.005 x 1.009 x 0.995 = 1.013). A more detailed explanation of each figure is provided in section II.N.1.e. of this final rule with comment period.

e. Calculation of CYs 2015, 2014, and 2013 SGRs (1) Detail on the CY 2015 SGR All of the figures used to determine the CY 2015 SGR are estimates that will be revised based on subsequent data. Any differences betw een these estimates and the actual measurementCMS-1612-FC 520

of these figures will be included in future re visions of the SGR and allowed expenditures and incorporated into subsequent PFS updates. (a) Factor 1– Changes in Fees for Physic ians’ Services (Before Applying Legislative Adjustments) for CY 2015

This factor is calculated as a weighted average of the CY 2015 changes in fees for the different types of services included in the de finition of physicians’ services for the SGR.

Medical and other health servic es paid using the PFS are estimated to account for approximately 89.6 percent of total allowed ch arges included in the SGR in CY 2015 and are updated using the percent change in the MEI. As discussed in section A of this fi nal rule with comment period, the percent change in the MEI for CY 2015 is 0.8 percent. Diagnostic la boratory tests are estimated to represent approximately 10.4 pe rcent of Medicare allowed ch arges included in the SGR for CY 2015. Medicare payments for these tests are updated by the Consumer Price Index for Urban Areas (CPI-U), which is 2.1 per cent for CY 2015. Section 1833(h )(2)(A)(iv) of th e Act requires that the CPI-U update applied to clinical laboratory tests be reduced by a multi-factor productivity adjustment (MFP adjustment) and, for each of years 2011 through 2015, by 1.75 percentage points (percentage adjustment). Th e MFP adjustment will not apply in a year where the CPI-U is zero or a percentage decrease. Furt her, the application of the MFP adjustment shall not result in an adjustment to the fee schedule of less than zero for a year. However, the application of the percentage ad justment may result in an adjust ment to the fee schedule being less than zero for a year and may result in paymen t rates for a year being less than such payment rates for the preceding year. The applicable pro ductivity adjustment for CY 2015 is -0.6 percent. Adjusting the CPI-U update by the productivity adjustment results in a 1.5 percent (2.1 percent (CPI-U) minus 0.6 percent (MFP adjustment)) upda te for CY 2015. Additionally, the percentage reduction of 1.75 percent is applied for CY s 2011 through 2015, as discussed previously.CMS-1612-FC 521

Therefore, for CY 2015, diagnostic laboratory tests wi ll receive an update of -0.3 percent. Table 37 shows the weighted average of the MEI and laboratory price changes for CY 2015. TABLE 37: Weighted-Average of the ME I and Laboratory Price Changes for CY 2015 Weight Update Physician 0.896 0.8% Laboratory 0.104 -0.3% Weighted-average 1.000 0.7%

We estimate that the weighted average incr ease in fees for physicians’ services in CY 2015 under the SGR (before applying any legisl ative adjustments) wi ll be 0.7 percent. (b) Factor 2 – Percentage Change in the Av erage Number of Part B Enrollees from CY 2014 to

CY 2015 This factor is our estimate of the percent change in the average number of fee-for-service

enrollees from CY 2014 to CY 2015. Services provided to Medicare Advantage (MA) plan enrollees are outside the scope of the SGR and are excluded from this estimate. We estimate that the average number of Medicare Part B fee-for-service enro llees will increase by 3.9 percent

from CY 2014 to CY 2015. Table 38 illustrates how this figure was determined. TABLE 38: Average Number of Medicare Part B Fee-For-Service Enrollees from CY 2014 to CY 2015 (Excluding Benefici aries Enrolled in MA Plans) CY 2014 CY 2015 Overall 49.350 million 50.794 million Medicare Advantage (MA) 16.237 million 16.389 million Net 33.113 million 34.405 million Percent Increase 0.2 percent 3.9 percent

An important factor affecting fee-for-service enrollment is beneficiary enrollment in MA plans. Because it is difficult to estimate the size of the MA enrollee population before the start of a CY, at this time we do not know how actual en rollment in MA plans will compare to currentestimates. For this reason, the estimate may change substantially as actual Medicare fee-forservice enrollment for CY 2015 becomes known.CMS-1612-FC 522

(c) Factor 3– Estimated Real Gross Dome stic Product Per Capita Growth in CY 2015 We estimate that the growth in real GDP per capita from CY 2014 to CY 2015 will be 0.7 percent (based on the annual grow th in the 10-year moving aver age of real GDP per capita 2006 through 2015). Our past experience indicates that there have also been changes in estimates of real GDP per capita growth made before the year begins and the actual ch ange in real GDP per capita growth computed after the year is comple te. Thus, it is possible that this figure will change as actual information on economic performance becomes available to us in CY 2015. (d) Factor 4 – Percentage Change in Expenditures for Physicians' Services Resulting From Changes in Statute or Regulations in CY 2015 Compared With CY 2014 The statutory and regulatory provisions that will affect expenditures for CY 2015 relative to CY 2014 are estimated to have an impact on e xpenditures of -18.1 percent. This is primarily due to payment reductions for e ligible professionals that are no t meaningful users of health information technology, the estimated reduction in PFS rates that will occur on April 1, 2015 absent a change in law, and expi ration of the work GPCI floor. (2) Detail on the CY 2014 SGR

A more detailed discussion of our revised estim ates of the four elements of the CY 2014

SGR follows. (a) Factor 1 – Changes in Fees for Physic ians' Services (Before Applying Legislative Adjustments) for CY 2014

This factor was calculated as a weighted-average of the CY 2014 changes in fees that apply for the different types of services included in the definition of physicians' services for the

SGR in CY 2014. We estimate that services paid using the PFS account for approximate ly 91.1 percent of total allowed charges included in the SGR in CY 2014. These se rvices were updated using theCMS-1612-FC 523

CY 2014 percent change in the MEI of 0.8 percent. We estimate that diagnostic laboratory tests represent approximately 8.9 percen t of total allowed charges in cluded in the SGR in CY 2014. For CY 2014, diagnostic laborat ory tests received an update of -0.8 percent. Table 39 shows the weighted-average of th e MEI and laboratory price changes for

CY 2014. TABLE 39: Weighted-Average of the MEI, and Laboratory Price Changes for CY 2014 Weight Update Physician 0.911 0.8 Laboratory 0.089 -0.8 Weighted-average 1.000 0.7

After considering the elements describe d in Table 39, we estimate that the weighted-average increase in fees for physic ians' services in CY 2014 under the SGR was 0.7 percent. Our estimate of th is factor in the CY 2014 PFS fina l rule with comment period was 0.6 percent (78 FR 74393). (b) Factor 2 – Percentage Change in the Aver age Number of Part B Enrollees from CY 2013 to

CY 2014 We estimate that the average number of Me dicare Part B fee-for-service enrollees (excluding beneficiaries enrolled in Medicare Advantage plans) increased by 0.2 percent in

CY 2014. Table 40 illustrates how we determined this figure. TABLE 40: Average Number of Medicare Part B Fee-For-Service Enrollees from CY 2013 to CY 2014 (Excluding Beneficiaries Enrolled in MA Plans)

CY 2013 CY 2014 Overall 47.878 million 49.350 million Medicare Advantage (MA) 14.842 million 16.237 million Net 33.036 million 33.113 million Percent Increase 0.5 percent 0.2 percentCMS-1612-FC 524

Our estimate of the 0.2 percent change in the number of fee-for-service enrollees, net of Medicare Advantage enrollment for CY 2014 co mpared to CY 2013, is different than our estimate of an increase of 2.2 percent in the CY 2014 PFS final rule with comment period (78 FR 74393)

. While our current projection based on data from 8 months of CY 2014 differs from our estimate of 2.2 percent when we ha d no actual data, it is still possi ble that our final estimate of this figure will be different once we have complete information on CY 2014 fee-for-service

enrollment. (c) Factor 3 –Estimated Real GDP Per Capita Growth in CY 2014 We estimate that the growth in real GDP per capita will be 0.7 percent for CY 2014 (based on the annual growth in the 10-year movi ng average of real GDP per capita (2005 through 2014)). Our past experience indicates that there have also been di fferences between our estimates of real per capita GDP growth made prior to the year's end and the actual change in this factor. Thus, it is possible that this figure will chan ge further as complete actual information on CY 2014 economic performance becomes available to us in CY 2015. (d) Factor 4 – Percentage Change in Expenditures for Physicians' Services Resulting From Changes in Statute or Regulations in CY 2014 Compared With CY 2013 The statutory and regulatory provisions that affected expenditures in CY 2014 relative to CY 2013 are estimated to have an impact on expenditu res of -2.4 percent. This impact is due to many different legislative or regulatory provi sions affecting spending in 2014 relative to 2013 including a 0.5 percent update for PFS services in 2014. (3) Detail on the CY 2013 SGR

A more detailed discussion of our final revise d estimates of the four elements of the

CY 2013 SGR follows. (a) Factor 1 – Changes in Fees fo r Physicians' Services for CY 2013CMS-1612-FC 525

This factor was calculated as a weighted av erage of the CY 2013 changes in fees that apply for the different types of services included in the definition of physicians' services for the

SGR in CY 2013. We estimate that services paid under the PFS account for approximate ly 90.1 percent of total allowed charges included in the SGR in CY 2013. These se rvices were updated using the CY 2013 percent change in the MEI of 0.8 percent. We estimate that diagnostic laboratory tests represent approximately 9.9 percen t of total allowed charges in cluded in the SGR in CY 2013. For CY 2013, diagnostic laborat ory tests received an update of -3.0 percent. Table 41 shows the weighted-average of th e MEI and laboratory price changes for

CY 2013. TABLE 41: Weighted-Average of the MEI, Laboratory, and Drug Price Changes for 2013 Weight Update Physician 0.901 0.8 Laboratory 0.099 -3.0 Weighted-average 1.00 0.4

After considering the elements describe d in Table 41, we estimate that the weighted-average increase in fees for physicia ns' services in CY 2013 under the SGR (before applying any legislative adjustments) was 0.4 pe rcent. This figure is a final one based on complete data for CY 2013. (b) Factor 2

– Percentage Change in the Average Nu mber of Part B Enrollees from CY 2012 to

CY 2013 We estimate the change in the number of fee-for-service enrollees (excluding

beneficiaries enrolled in MA plans) from CY 2012 to CY 2013 was 0.5 percent. Our calculation of this factor is based on complete data from CY 2013. Table 42 illustra tes the calculation of

this factor.CMS-1612-FC 526

TABLE 42: Average Number of Medicare Part B Fee-For-Service Enrollees from CY 2012 to CY 2013 (Excluding Beneficiaries Enrolled in MA Plans)

CY 2012 CY 2013 Overall 46.468 million 47.878 million Medicare Advantage (MA) 13.587 million 14.842 million Net 32.881 million 33.036 million Percent Change

.................. 0.5 percent

(c) Factor 3 – Estimated Real GDP Per Capita Growth in CY 2013 We estimate that the growth in real per capita GDP was 0.9 percent in CY 2013 (based on the annual growth in the 10-y ear moving average of real GDP per capita (2004 through 2013)). This figure is a final one based on complete data for CY 2013. (d) Factor 4 – Percentage Change in Expenditures for Physicians’ Services Resulting From Changes in Statute or Regulations in CY 2013 Compared With CY 2012. Our final estimate for the net impact on e xpenditures from the st atutory and regulatory provisions that affect expenditure s in CY 2013 relative to CY 2012 is -0.5 percent. This impact is due to many different legislat ive or regulatory provisions affec ting spending in 2013 relative to 2012, including provisions of the Amer ican Taxpayer Relief Act in 2013. 2. The Update Adjustment Factor (UAF) Section 1848(d) of the Act pr ovides that the PFS update is equal to the product of the MEI and the UAF. The UAF is applied to make act ual and target expenditures (referred to in the statute as “allowed expenditures”) equal. As discussed previously, al lowed expenditures are equal to actual expenditures in a base period upda ted each year by the SGR. The SGR sets the annual rate of growth in allowed expenditures and is determined by a formula specified in section 1848(f) of the Act. We not e that the conversion factor for the time period from January 1, 2015 through March 31, 2015 will reflect a 0.0 percent update based on section 101 of PAMA.CMS-1612-FC 527

Beginning on April 1, 2015 through December 31, 2015, the standard calculation of the PFS CF under the SGR formula would apply

The calculation of the UAF is not affected by sequestration. Pursuant to 2 U.S.C. 906(d)(6), “The Secretary of Health and Hu man Services shall not take into account any reductions in payment amounts which have been or may be effected under [sequestration], for purposes of computing any adjustments to paym ent rates under such title XVIII.” Therefore, allowed charges, which are unaffected by seque stration, were used to calculate physician expenditures in lieu of Medicare payments plus beneficiary cost-shari ng. As a result, neither actual expenditures nor allowed expenditures were adjusted to reflect the impact of sequestration.

a. Calculation under Current Law Under section 1848(d)(4)(B) of the Act, th e UAF for a year beginning with CY 2001 is equal to the sum of the following--

● Prior Year Adjustment Compone nt. An amount determined by— ++ Computing the difference (which may be positive or negative) between the amount of the allowed expenditures for physicians ’ services for the prior year (t he year prior to the year for which the update is being determined) and th e amount of the actual expenditures for those services for that year; ++ Dividing that difference by the amount of the actual expenditures for those services for that year; and ++ Multiplying that quotient by 0.75.

● Cumulative Adjustment Component. An amount determined by—CMS-1612-FC 528

++ Computing the difference (which may be positive or negative) between the amount of the allowed expenditures for physicians' services from April 1, 1996, through the end of the prior year and the amount of the act ual expenditures for those se rvices during that period; ++ Dividing that difference by actual expenditu res for those services for the prior year as increased by the SGR for the year for wh ich the UAF is to be determined; and ++ Multiplying that quotient by 0.33. Section 1848(d)(4)(E) of the Act requires the Secretary to recalculate allowed expenditures consistent with se ction 1848(f)(3) of the Act. As discussed previously, section 1848(f)(3) specifies that the SGR (and, in tur n, allowed expenditures) for the upcoming CY (CY 2015 in this case), the current CY (that is, CY 2014) and the preceding CY (that is, CY 2013) are to be determined on the basis of the best data available as of September 1 of the current year. Allowed expenditures for a year ge nerally are estimated initially and subsequently

revised twice. The second revi sion occurs after the CY has e nded (that is, we are making the second revision to CY 2013 allowed expenditures in this final rule with comment).

Table 43 shows the historical SGRs corre sponding to each period through CY 2015.CMS-1612-FC 529

TABLE 43: Annual and Cumulative Allowed and Actual Expenditures for Physicians' Services from April 1, 1996 through the End of the Upcoming Calendar Year

Period Annual Allowed Expenditures ($ in billions) Annual Actual Expenditures ($ in billions) Cumulative Allowed Expenditures ($ in billions) Cumulative Actual Expenditures ($ in billions) FY/CY SGR

4/1/96-3/31/97 47.0 47.0 47.0 47.0

........................ 4/1/97-3/31/98 48.5 47.2 95.6 94.3 3.2 4/1/98-3/31/99 50.6 48.1 146.2 142.4 4.2 1/1/99-3/31/99 12.7 12.5 146.2 142.4 ........................ 4/1/99-12/31/99 40.5 37.2 186.7 179.6 6.9 1/1/99-12/31/99 53.2 49.7 18 6.7 179.6 ........................ 1/1/00-12/31/00 57.1 54.4 243.7 234.0 7.3 1/1/01-12/31/01 59.7 61.5 303.4 295.5 4.5 1/1/02-12/31/02 64.6 64.8 368.0 360.3 8.3 1/1/03-12/31/03 69.3 70.4 437.3 430.7 7.3 1/1/04-12/31/04 73.9 78.5 511.2 509.1 6.6 1/1/05-12/31/05 77.0 83.8 588.2 593.0 4.2 1/1/06-12/31/06 78.2 85.1 666.4 678.1 1.5 1/1/07-12/31/07 80.9 85.1 747.2 763.1 3.5 1/1/08-12/31/08 84.5 87.3 831.8 850.4 4.5 1/1/09-12/31/09 89.9 91.1 921.7 941.5 6.4 1/1/10-12/31/10 97.9 96 1,019.6 1,037.4 8.9 1/1/11-12/31/11 102.5 99.5 1,122.2 1,136.9 4.7 1/1/12-12/31/12 107.8 101.1 1,230.0 1,238.0 5.1 1/1/13-12/31/13 109.2 102.5 1,339.1 1,340.5 1.3 1/1/14-12/31/14 108.3 103.3 1,447.4 1,443.8 -0.8 1/1/15-12/31/15 93.5 N/A 1,540.9 N/A -13.7

Notes: (1) Allowed expenditures in the first year (April 1, 1996-March 31, 1997) are equal to actual expenditures. All subsequ ent figures are equal to quarterly allowed expenditure figures increased by the applicable SGR. Cumulative allo wed expenditures are equal to t he sum of annual allowed expenditures. We provide more de tailed quarterly allowed and actual expenditu re data on our website at the following a ddress: http://www.cms.hhs.gov/Sust ainableGRatesConFact/ . We expect to update the website with th e most current information later this month. (2) Allowed expenditures for the first qua rter of 1999 are based on the FY 1999 SGR. (3) Allowed expenditures for the last three quarters of 1999 are based on the FY 2000 SGR.

Consistent with section 1848(d )(4)(E) of the Act, Table 43 includes our second revision of allowed expenditures for CY 2013, a recalculation of allowed expenditures for CY 2014, and our initial estimate of allowed expenditures for CY 2015. To determine the UAF for CY 2015, the statute requires that we use allowed and actual expendit ures from April 1, 1996 through December 31, 2014 and the CY 2015 SGR. Consistent with section 1848(d)(4)(E) of the Act, we will be making revisions to the CY 2014 and CY 2015 SGRs and CY 2014 and CY 2015 allowedCMS-1612-FC 530

expenditures. Because we have incomplete ac tual expenditure data for CY 2014, we are using an estimate for this period. Any difference be tween current estimates and final figures will be taken into account in determining the UAF for future years. We are using figures from EE10 in the following statutory formula:

33

. 0 75

. 0 14 / 12 96 / 4 14 / 12 96 / 4 15 × × − + × −

− −

= 15 14 14 14 14 SGR Actual Actual Target Actual Actual Target UAF

UAF 15 = Update Adjustment Factor for CY 2015= 3.0 percent Target 14 = Allowed Expenditures for CY 2014= $108.3 billion

Actual 14 = Estimated Actual Expenditures for CY 2014 = $103.3 billion Target 4/96-12/14 = Allowed Expenditures from 4/1/1996 - 12/31/2014 = $1,447.40 billion

Actual 4/96-12/14 = Estimated Actual Expenditures fr om 4/1/1996 - 12/31/2014 = $1,443.80 billion

SGR 15 = -13.7 percent (0.863)

Section 1848(d)(4)(D) of the Act indicates that the UAF determined under section 1848(d)(4)(B) of the Act for a year may not be less than -0.07 or greater than 0.03. Since 0.049 (4.9 percent) is greater than 0.03, the UAF for CY 2015 will be 3 percent. Section 1848(d)(4)(A)(ii ) of the Act indicates that 1.0 should be added to the UAF determined under section 1848(d)(4)(B) of the Act. Thus, adding 1.0 to 0.03 makes the UAF equal to 1.03. 3. Percentage Change in the MEI for CY 2015 The MEI is required by section 1842(b)(3) of the Act, which states that prevailing charge levels beginning after June 30, 1973, may not exceed the level from the previous year except to % 9

. 4 33

. 0 863

. 3

. 103 $ 80

. 1443 $ 4

. 447 , 1 $ 75

. 0 3

. 103 $ 3

. 103 $ 3

. 108 $

= × × − + × −CMS-1612-FC 531

the extent that the Secretary finds, on the basi s of appropriate economic index data, that the higher level is justified by year -to-year economic changes. The current form of the MEI was detailed in the CY 2014 PFS final rule (78 FR 74264) , which revised and recl assified certain cost categories, price proxies, and expense categories. The MEI measures the weighted-average annua l price change for various inputs needed to produce physicians' services. The MEI is a fixe d-weight input price inde x, with an adjustment for the change in economy-wide multifactor productivity. This index, which has CY 2006 base year weights, is comprised of two broad categorie s: (1) physician's own time; and (2) physician's practice expense (PE). The physician’s compensation (own time) component represents the net income portion of business receipts and primarily reflects the input of the physician's own time into the production of physicians' services in physicians' offices. This category consists of two subcomponents: (1) wages and salari es; and (2) fringe benefits. The physician’s practice expense (PE) categ ory represents nonphysic ian inputs used in the production of services in physicians' offices. This category consists of wages and salaries and fringe benefits for nonphys ician staff (who cannot bill inde pendently) and other nonlabor inputs. The physician's PE compone nt also includes the following categories of nonlabor inputs: office expenses; medical materials and supplies; professional liability insurance; medical equipment; medical materials and supplies; and other professional expenses. Table 44 lists the MEI cost categories with associated weights and percent changes for price proxies for the CY 2015 update. The CY 2015 non-productivity adjusted MEI update is 1.7 percent and reflects a 1.9 per cent increase in physician’s own time and a 1.5 percent increase in physician’s PE. Within the physician’s PE, the la rgest increase occurre d in postage, which increased 5.4 percent.CMS-1612-FC 532

For CY 2015, the increase in the MEI is 0.8 percent, which reflect s an increase in the non-productivity adjusted MEI of 1.7 percent and a productivity adjustment of 0.9 percent (which is based on the 10-year moving aver age of economy-wide private nonfarm business multifactor productivity). The BLS is the agency that publishes the official measure of private non-farm business MFP. Please see http://www .bls.gov/mfp, which is the link to the BLS historical published data on the measure of MFP.CMS-1612-FC 533

TABLE 44: Increase in the Medicare Economic Index Update for CY 2015 1

Revised Cost Category 2006 Revised Cost Weight (percent) 2 CY15 Update (percent) MEI Total, productivity adjusted 100.000 0.8 Productivity: 10-year moving average of MFP 1 N/A 5 0.9 MEI Total, without productivity adjustment 100.000 1.7 Physician Compensation 3 50.866 1.9 Wages and Salaries 43.641 1.9 Benefits 7.225 2.0 Practice Expense 49.134 1.5 Non-physician compensation 16.553 1.8 Non-physician wages 11.885 1.8 Non-health, non-physician wages 7.249 2.0 Professional & Related 0.800 1.9 Management 1.529 2.2 Clerical 4.720 1.9 Services 0.200 1.2 Health related, non-physician wages 4.636 1.5 Non-physician benefits 4.668 1.9 Other Practice Expense 32.581 1.4 Utilities 1.266 4.0 Miscellaneous Office Expenses 2.478 1.0 Chemicals 0.723 -1.1 Paper 0.656 3.3 Rubber & Plastics 0.598 1.0 All other products 0.500 1.7 Telephone 1.501 0.0 Postage 0.898 5.4 All Other Professional Services 8.095 1.7 Professional, Scientific, and Tech. Services 2.592 1.8 Administrative and support & waste 3.052 1.9 All Other Services 2.451 1.2 Capital 10.310 1.8 Fixed 8.957 1.9 Moveable 1.353 0.8 Professional Liability Insurance 4 4.295 -0.1 Medical Equipment 1.978 -0.3 Medical supplies 1.760 -0.2 1 The forecasts are based upon the late st available Bureau of Labor Statisti cs data on the 10-year average of BLS private nonfarm business multifactor productivity published on July 9, 2014. ( http://www.bls.gov/news.release/prod3.nr0.htm ) 2 The weights shown for the MEI components are the 2006 base-year weights, which may not sum to subtotals or totals because of rounding. The MEI is a fixed-weight, Laspeyres-type input price index whose category weights indicate the distribution of expenditures among the inputs to physi cians' services for CY 2006. ToCMS-1612-FC 534

determine the MEI level for a given year, the price pr oxy level for each component is multiplied by its 2006 weight. The sum of these products (weights multiplied by the price index levels) over all cost categories yields the composite MEI level for a given year. The annual percent change in the MEI levels is an estimate of price change over time for a fixed market bask et of inputs to physicians' services. 3 The measures of Productivity, Employment Cost Indexes, as well as the various Producer and Consumer Price Indexes can be found on the Bureau of Labor Statistics Web site at http://stats.bls.gov

. 4 Derived from a CMS survey of several major commercial insurers. 5 Productivity is factored into the MEI categories as an adjustment; therefore, no explicit weight exists for productivity in the MEI.

4. Physician and Anesthesia Fee Schedule Conversion Factors for CY 2015

The CY 2015 PFS CF for January 1, 2015 through March 31, 2015 is $35.8013. The CY 2015 PFS CF for April 1, 2015 through Decembe r 31, 2015 is $28.2239. The CY 2015 national average anesthesia CF for January 1, 2015 through March 31, 2015 is $22.5550 The CY 2015 national average anesthesia CF for Ap ril 1, 2015 through December 31, 2015 is $17.7913. a. PFS Update and Conversion Factors (1) CY 2014 PFS Update The formula for calculating the PFS update is set forth in section 1848(d)(4)(A) of the Act. In general, the PFS update is determined by multiplying the CF for the previous year by the percentage increase in the MEI le ss productivity times the UAF, wh ich is calculated as specified under section 1848(d)(4)(B) of the Act. (2) CY 2015 PFS Conversion Factors Generally, the PFS CF for a year is calculat ed in accordance with section 1848(d)(1)(A) of the Act by multiplying the previous year’s CF by the PFS update. We note section 101 of the Medicare Improveme nts and Extension Act, Division B of the Tax Relief and Health Care Act of 2006 (MIEA- TRHCA) provided a 1-y ear increase in the CY 2007 CF and specified that the CF for CY 2008 must be computed as if the 1-year increase had never applied. Section 101 of the Medicare, Medicaid, and SCHIP Extension Act of 2007 (MMSEA) provided a 6-month increase in the CY 2008 CF, from January 1, 2008, through June 30, 2008,CMS-1612-FC 535

and specified that the CF for the remaining portion of CY 2008 and the CFs for CY 2009 and subsequent years must be computed as if the 6-month increase had never applied.

Section 131 of the MIPPA extended the increas e in the CY 2008 CF that applied during the first half of the year to the entire year, provided for a 1.1 percent increase to the CY 2009 CF, and specified that the CFs for CY 2010 and subs equent years must be computed as if the increases for CYs 2007, 2008, and 2009 had never applied. Section 1011(a) of the DODAA an d section 5 of the TEA specified a zero percent update for CY 2010, effective January 1, 2010 through March 31, 2010. Section 4 of the Continuing Extension Ac t of 2010 (CEA) extended the zero percent update for CY 2010 through May 31, 2010. Subsequently, section 101(a )(2) of the PACMBPRA provide d for a 2.2 percent update to the CF, effective from June 1, 2010 to November 30, 2010. Section 2 of the Physician Payment and Therapy Relief Act of 2010 (Pub. L. No. 111- 286) extended the 2.2 percent updat e through the end of CY 2010. Section 101 of the MMEA provided a zero perc ent update for CY 2011, effective January 1, 2011 through December 31, 2011, and specified that the CFs for CY 2012 and subsequent years must be computed as if the increases in previous years had never applied. Section 301 of the Temporary Payroll Ta x Cut Continuation Act of 2011 (TPTCCA) provided a zero percent update effectiv e January 1, 2012 through February 29, 2012, and specified that the CFs for subsequent time periods must be computed as if the increases in previous years had never applied.

Section 3003 of the Middle Class Tax Relie f and Job Creation Act of 2012 (Job Creation Act) provided a zero percent update effec tive March 1, 2012 through December 31, 2012, andCMS-1612-FC 536

specified that the CFs for subsequent time periods must be computed as if the increases in previous years had never applied. Section 601 of the American Taxpayer Re lief Act (ATRA) of 2012 (Pub. L. 112-240) provided a zero percent update for CY 2013, effective January 1, 2013 through December 31, 2013, and specified that the CFs for subsequent time periods must be computed as if the increases in previous year s had not been applied. Section 1101 of the Pathway for SGR Refo rm Act of 2013 (Pub. L. 113-67) provided a 0.5 percent update to the PFS CF, effective January 1, 2014 through March 31, 2014 and specified that the CFs for subsequent time periods must be computed as if the increases in previous years had not been applied.

Section 101 of the Protecti ng Access to Medicare Act of 2014 (Pub. L. 113-93) (PAMA) extended this 0.5 percent update through Decem ber 31, 2014. Section 101 of the PAMA also provides a 0.0 percent update fo r services furnished on or afte r January 1, 2015, through March 31, 2015, and specified that the CFs for subsequent time periods must be computed as if the increases in previous year s had not been applied. Therefore, under current law, the CF that would be in effect in CY 2014 had the prior increases specified above not applied is $27.2006. In addition, when calculating the PFS CF for a year, section 1848(c)(2 )(B)(ii)(II) of the Act requires that increases or decreases in R VUs may not cause the amount of expenditures for the year to differ more than $20 million from what it would have been in the absence of these changes. If this threshold is exceeded, we must make adjustment s to preserve budget neutrality.

We estimate that CY 2015 RVU changes would result in an increase in Medicare physician expenditures of more than $20 million. Accord ingly, we are decreasing the CF by 0.06 percentCMS-1612-FC 537

to offset this estimated increase in Medi care physician expenditures due to the CY 2015 RVU changes. For January 1, 2015 through March 31, 2015, the PFS update will be 0.0 percent

consistent with section 101 of PAMA. After a pplying the budget neutrality adjustment described above, the conversion factor for January 1, 2015 through March 31, 2015 will be $35.8013. After March 31, 2015 the standard calculation of the PFS CF under the SGR formula would apply. Therefore, from April 1, 2015 through December 31, 2015 the conversion factor would be $28.2239. This final rule with commen t period announces a reduction to payment rates for physicians' services of 21.2 percen t during this time period in CY 2015 under the SGR

formula. By law, we are required to make these reduc tions in accordance with section 1848(d) and (f) of the Act, and these reductions can only be averted by an Act of C ongress. While Congress has provided temporary relief from these reduct ions every year since 2003, a long-term solution

is critical. We will continue to work with Congress to fix this untenable situation so doctors and beneficiaries no longer have to worry about th e stability and adequacy of payments from

Medicare under the PFS.

We illustrate the calculation of the CY 2015 PFS CF in Table 45.CMS-1612-FC 538

TABLE 45: Calculation of the CY 2015 PFS CF January 1, 2015 through March 31, 2015 Conversion Factor in e ffect in CY 2014 $35.8228 Update 0.0 percent (1.00) CY 2015 RVU Budget Neutrality Adjust ment -0.06 percent (0.9994) CY 2015 Conversion Factor (1/1/2015 through 3/31/2015) $35.8013 April 1, 2015 through December 31, 2015 Conversion Factor in e ffect in CY 2014 $35.8228 CY 2014 Conversion Factor had statutory increases not applied $27.2006 CY 2015 Medicare Economic Index 0.8 percent (1.008) CY 2015 Update Adjustment Factor -3.0 percent (1.03) CY 2015 RVU Budget Neutrality Adjust ment -0.06 percent (0.9994) CY 2015 Conversion Factor (4/1/2015 through 12/31/2015) $28.2239 Percent Change in Conversion Factor on 4/1/2015 (relative to the CY 2014 CF) -21.2% Percent Change in Update (without budget neutrality adjustment) on 4/1/2015 (relative to the CY 2014 CF) -20.9%

We note payment for services under the PFS will be calculated as follows: Payment = [(Work RVU x Work GPCI) + (P E RVU x PE GPCI) + (Malpractice RVU x Malpractice GPCI)] x CF.

b. Anesthesia C onversion Factors

We calculate the anesthesia CFs as indicated in Table 46. Anesthesia services do not have RVUs like other PFS services. Therefore, we account for any necessary RVU adjustments through an adjustment to the anesthesia CF to si mulate changes to RVUs. More specifically, if there is an adjustment to the work, PE, or malp ractice RVUs, these adjust ments are applied to the respective shares of the anesthesia CF as th ese shares are proxies for the work, PE, and malpractice RVUs for anesthesia services. Info rmation regarding the an esthesia work, PE, and malpractice shares can be found at the following: https://www.cms.gov/center/anesth.asp

.CMS-1612-FC 539

The anesthesia CF in effect in CY 2014 is $22.6765. Section 101 of PAMA provides for a 0.0 percent update from January 1, 2015 th rough March 31, 2015. Af ter applying the 0.9994 budget neutrality factor described above, the an esthesia CF in effect from January 1, 2015 through March 31, 2015 will be $22.5550. The table below includes adjustments to the anesthesia CF that are analogous to the physician fee schedule CF with other adjustments th at are specific to anesthesia. In order to calculate the CY 2015 anesthesia CF for Ap ril 1, 2015 through December 31, 2015, the statute requires us to calculate the CFs for all previous y ears as if the various le gislative changes to the CFs for those years had not occurred. The resulti ng CF is then adjusted for the update (the MEI, less multi-factor productivity and increased by th e UAF). The national average CF is then adjusted for anesthesia specific work, practice expense and malpractice factors that must be applied to the anesthesia CF as the anesthesia fee schedule does not ha ve RVUs. Accordingly, under current law, the an esthesia CF in effect in CY 2015 for the time period from April 1, 2015 through December 31, 2015 is $17.7913. We ill ustrate the calculation of the CY 2015 anesthesia

CFs in Table 45.CMS-1612-FC 540

TABLE 46: Calculation of the CY 2015 Anesthesia CF January 1, 2015 through March 31, 2015 CY 2014 National Average Anesthesia CF $22.6765 Update 0.0 percent (1.00) CY 2015 RVU Budget Neutrality Adjustment 0.0006 percent (0.9994) CY 2015 Anesthesia Fee Sc hedule Practice Expense Adjustment 0.005 percent (.99524) CY 2015 National Average Anesthesia CF (1/1/2015 through 3/31/2015) $22.5550 April 1, 2015 through December 31, 2015 2014 National Average Anesthesia Conversion Factor in effect in CY 2015 $22.6765

2014 National Anesthesia Conversion Factor had Statutory Increases Not Applied $17.2283 CY 2015 Medicare Economic Index 0.8 percent (1.008) CY 2015 Update Adjustment Factor 3.0 percent (0.9994) CY 2015 Budget Neutrality Work and Malpractice Adjustment -0.06 percent (0.9994)

CY 2015 Anesthesia Fee Sc hedule Practice Expense Adjustment 0.005 percent (.99524)

CY 2015 Anesthesia Conversion Factor (4/1/2015 through 12/31/2015) $17.7913 Percent Change from 2014 to 2015 (4/1/2015 through 12/31/2015) -21.5%CMS-1612-FC 541

III. Other Provisions of the Final Ru le with Comment Period Regulation

A. Ambulance Extender Provisions 1. Amendment to Section 1834(l)(13) of the Act Section 146(a) of the MIPPA amended section 1834(l)(13)(A) of the Act to specify that, effective for ground ambulance services furnished on or after July 1, 2008 and before January 1, 2010, the ambulance fee schedule amounts for ground am bulance 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. The payment add-ons under section 1834(l)(13) (A) of the Act have been extended several times. Recently, section 1104(a) of the Path way for SGR Reform Act of 2013, enacted on December 26, 2013, as Division B (Medicare and Other Health Provisions) of Pub L. 113-67, amended section 1834(l)(13)(A) of the Act to extend the payment add-ons described above through March 31, 2014. Subsequently, section 104( a) of the Protecting Access to Medicare Act of 2014 (Pub. L. 113-93, enacted on April 1, 2014) am ended section 1834(l)(13)(A) of the Act to extend the payment add-ons again through Marc h 31, 2015. Thus, these payment add-ons also apply to covered ground ambulance transports furn ished before April 1, 2015. (For a discussion of past legislation extending section 1834(l)(13) of the Act, please see the CY 2014 PFS final rule (78 FR 74438 through 74439)). These statutory requirements are self-imple menting. A plain reading of the statuteCMS-1612-FC 542

requires only a ministerial application of the ma ndated rate increase, and does not require any substantive exercise of discretion on the part of the Secretary. In the CY 2015 PFS proposed rule (79 FR 40372), we proposed to revise §414.610(c)(1)( ii) to conform the regulations to these statutory requirements. We received one commen t regarding this proposal. A summary of the comment we received and our response are set forth below. Comment: One commenter supported the implementation of the ambulance payment add-ons. The commenter also agreed that these provisions are self-implementing. Response: We thank the commenter fo r their support of these provisions. After consideration of the public comment received, we are finalizing our proposal to revise §414.610(c)(1)(ii) to c onform the regulations to th ese statutory requirements.

2. Amendment to Section 1834(l)(12) of the Act Section 414(c) of the Medicare Prescripti on Drug, Improvement and Modernization Act of 2003 (Pub. L. 108-173, enacted on December 8, 2003) (MMA) added section 1834(l)(12) to the Act, which specified that in the case of ground ambulance services furnished 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 sh all provide for a percent increase in the base rate of the fee schedule for such transports. The statute requires this per cent increase to be based on the Secretary’s estimate of the average cost per trip for such services (not taking into account mileage) in the lowest quartile of all rural c ounty populations as compar ed to the average cost per trip for such services (not taking into account mileage) in th e highest quartile of rural county populations. Using the methodology specified in the July 1, 2004 interim final rule (69 FR 40288), we determined that this percent increase was equal to 22.6 percent. As required by the MMA, this payment increase was applied to grou nd ambulance transports that originated in a “qualified rural area”; that is, to transports that originated in a rural area included in those areasCMS-1612-FC 543

comprising the lowest 25th percen tile of all rural populations a rrayed by population density. For this purpose, rural areas included Goldsmith areas (a type of rural census tract). This rural bonus is sometimes referred to as the “Super Rural Bo nus” and the qualified ru ral areas (also known as “super rural” areas) are identified during the clai ms adjudicative process via the use of a data

field included on the CMS- supplied ZIP code File. The Super Rural Bonus under section 1834(l)(12) of the Ac t has been extended several times. Recently, section 1104(b) of the Path way for SGR Reform Act of 2013, enacted on December 26, 2013, as Division B (Medicare and Other Health Provisions) of Pub. L. 113-67, amended section 1834(l)(12)(A) of the Act to extend this rural bonus through March 31, 2014. Subsequently, section 104(b) of the Protec ting Access to Medicare Act of 2014 (Pub. L. 113-93, enacted on April 1, 2014) amended section 1834(l)( 12)(A) of the Act to extend this rural bonus again through March 31, 2015. Therefore, we ar e 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 before April 1, 2015 where transportation originates in a qualified rural area. (For a discussion of past legislation extending sect ion 1834(l)(12) of the Act, please see the CY 2014 PFS final rule (78 FR 74439 through 74440)). These statutory provisions are self-impleme nting. Together, these statutory provisions require a 15-month extension of this rural bonus (which was previously established by the Secretary) through March 31, 2015, and do not require any substantive exercise of discretion on the part of the Secretary. In the CY 2015 PFS proposed rule (79 FR 40372), we proposed to revise §414.610(c)(5)(ii) to conf orm the regulations to these statutory requirements. We received one comment regarding this proposal. A summary of the comment we received and our response are set forth below. Comment: One commenter supported the implem entation of the percent increase in theCMS-1612-FC 544

base rate of the fee schedule for transports in areas defined as s uper rural. The commenter also agreed with CMS that these pr ovisions are self-implementing. Response: We thank the commenter fo r their support of these provisions. After consideration of the public comment received, we are finalizing our proposal to revise §414.610(c)(5)(ii) to conf orm the regulations to thes e statutory requirements. B. Changes in Geographic Area Delineations for Ambulance Payment 1. Background Under the ambulance fee schedule, the Medicare program pays for ambulance transportation services for Medicare benefici aries when other means of transportation are contraindicated by the beneficiar y’s medical condition, and all ot her coverage requirements are

met. Ambulance services are classified into di fferent levels of ground (including water) and air ambulance services based on the medically necessa ry treatment provided during transport.

These services include the fo llowing levels of service:

● For Ground-- ++ Basic Life Support (BLS) (emergency and non-emergency) ++ Advanced Life Support, Level 1 (A LS1) (emergency and non-emergency) ++ Advanced Life Support, Level 2 (ALS2) ++ Paramedic ALS Intercept (PI) ++ Specialty Care Transport (SCT)

● For Air-- ++ Fixed Wing Air Ambulance (FW) ++ Rotary Wing Air Ambulance (RW) a. Statutory Coverage of Ambulance Services Under sections 1834(l) and 1861(s)(7) of the Act, Medicare Part B (SupplementalCMS-1612-FC 545

Medical Insurance) covers and pays for ambul ance services, to the extent prescribed in regulations, when the use of other methods of transportation would be contraindicated by the beneficiary’s medical condition. The House Ways and Means Committee and Senate Finance Committee Reports that accompanied the 1965 Social Security Amendments suggest that the Congress intended that--

● The ambulance benefit cover transporta tion services only if other means of transportation are contrai ndicated by the beneficiary’s medical condition; and

● Only ambulance service to local facilities be covered unless necessa ry services are not available locally, in which case, tr ansportation to the nearest facil ity furnishing those services is covered (H.R. Rep. No. 213, 89 th Cong., 1 st Sess. 37 and Rep. No. 404, 89 th Cong., 1 st Sess. Pt 1, 43 (1965)). The reports indicate that transportation ma y also be provided from one hospital to another, to the beneficiary’s home, or to an extended care facility. b. Medicare Regulations for Ambulance Services Our regulations relating to ambulance services are set forth at 42 CFR part 410, subpart B and 42 CFR part 414, subpart H. Section 410.10(i ) lists ambulance services as one of the

covered medical and other health services under Medicare Part B. Therefore, ambulance services are subject to basic conditions and lim itations set forth at §410.12 and to specific conditions and limitations included at §410.40 a nd §410.41. Part 414, subpart H, describes how payment is made for ambulance services covered by Medicare.

2. Provisions of the Final Rule Historically, the Medicare ambulance fee sche dule has used the same geographic area designations as the acute care hos pital inpatient prospective pa yment system (IPPS) and other Medicare payment systems to take into account appropriate urban and rural differences. ThisCMS-1612-FC 546

promotes consistency across the Medicare progr am, and it provides for use of consistent geographic standards for Medi care payment purposes. The current geographic areas used under the ambulance fee schedule are based on OMB standards published on December 27, 2000 (65 FR 82228 through 82238), Census 2000 data, and Census Bureau population estimates for 2007 and 2008 (OMB Bulletin No. 10-02). For a

discussion of OMB’s delineation of Core-B ased Statistical Areas (CBSAs) and our implementation of the CBSA definitions under the ambulance fee schedule, we refer readers to the preamble of the CY 2007 Ambulance Fee Schedule proposed ru le (71 FR 30358 through 30361) and the CY 2007 PFS final rule (71 FR 69712 through 69716). On February 28, 2013, OMB issued OMB Bulletin No. 13-01, which esta blished revised delineations for Metropolitan Statistical Areas (MSAs), Micropolitan Statisti cal Areas, and Combined Statistical Areas, and provided guidance on the use of the delineations of these statistical areas. A copy of this bulletin may be obtained at http://www.whitehouse.gov/sites/defa ult/files/omb/bulletins/2013/b-13- 01.pdf . According to OMB, “[t]his bulletin prov ides the delineations of all Metropolitan Statistical Areas, Metropolitan Divisions, Micropolitan Statisti cal Areas, Combined Statistical Areas, and New England City and Town Areas in the United States and Puerto Rico based on the standards published on June 28, 2010, in the Federal Register (75 FR 37246 - 37252) and

Census Bureau data.” OMB defines an MSA as a CBSA associated with at least one urbanized area that has a population of at least 50,000, and a Micropolitan Statis tical Area (referred to in this discussion as a Micropolitan Area) as a CBSA a ssociated with at least one urban cluster that has a population of at least 10,000 but less than 50,000 (75 FR 37252). Counties that do not qualify for inclusion in a CBSA are deemed “Outsi de CBSAs.” We note that, when referencing the new OMB geographic boundaries of statistical areas, we are using the term “delineations” consistent with OMB’s use of the term (75 FR 37249).CMS-1612-FC 547

Although the revisions OMB published on Februa ry 28, 2013 are not as sweeping as the changes made when we adopted the CBSA geographic designations for CY 2007, the February 28, 2013 OMB bulletin does contain a number of significant changes. For example, we stated in the CY 2015 PFS proposed rule (79 FR 40373) that if we adopt the revised OMB delineations, there would be new CBSAs, urban c ounties that would become rural, rural counties that would become urban, and existing CBSAs that would be split apart. We have reviewed our findings and impacts relating to the new OMB delineations, and find no compelling reason to further delay implementation. We stated in the pr oposed rule that we beli eve it is important for

the ambulance fee schedule to use the latest labor market area delineations available as soon as reasonably possible to maintain a more accurate and up-to-date payment system that reflects the reality of population shifts. Additionally, in the FY 2015 IPPS proposed ru le (79 FR 28055), we also proposed to adopt OMB’s revised delineations to identify urban areas and rural areas for purposes of the IPPS wage index. This proposal was finalized in the FY 2015 IPPS final rule (79 FR 49952). For the reasons discussed above, we believe it would be appropriate to adopt the same geographic area delineations for use under the am bulance fee schedule as are used under the IPPS and other Medicare payment systems. Thus, we proposed to implement the new OMB delineations as described in the February 28, 2013 OMB Bulletin No. 13-01 beginning in CY 2015 to more accurately identify urban and ru ral areas for ambulance fee schedule payment purposes. We believe that the updated OMB delin eations more realistically reflect rural and urban populations, and that the use of such delin eations under the ambulance fee schedule would result in more accurate payment. Under the ambu lance fee schedule, consistent with our current definitions of urban and rural areas (§414.605), MSAs would continue to be recognized as urban areas, while Micropolitan and othe r areas outside MSAs, and rural census tracts within MSAs (asCMS-1612-FC 548

discussed below), would be r ecognized as rural areas.

In addition to the OMB’s statistical area de lineations, the current geographic areas used

in the ambulance fee schedule also are based on rural census tracts determined under the most

recent version of the Goldsmith Modification. These rural census tracts are considered rural areas under the ambulance fee schedule (see §414.605). For certain rural add-ons, section 1834(l) of the Act requires that we use the most recent version of the Goldsmith Modification to

determine rural census tracts within MSAs. In the CY 2007 PFS final rule (71 FR 69714 through 69716), we adopted the most recent (at that tim e) version of the Goldsmith Modification, designated as Rural-Urban Commuting Area (RUC A) codes. RUCA codes use urbanization, population density, and daily commuting data to categorize every census tr act in the country. For a discussion about RUCA codes, we refer th e reader to the CY 2007 PFS final rule (71 FR 69714 through 69716). As stated previously, on February 28, 2013, OMB issued OMB Bulletin No. 13-01, which established revised delineatio ns for Metropolitan Statistical Areas, Micropolitan Statistical Areas, and Combined St atistical Areas, and provided guidance on the

use of the delineations of these st atistical areas. Several modifi cations of the RUCA codes were necessary to take into account updated commuti ng data and the revised OMB delineations. We refer readers to the U.S. Department of Agricu lture’s Economic Research Service website for a detailed listing of updated RUCA codes found at http://www.ers.usda.gov/data-products/ruralurban-commuting-area-codes.aspx . The updated RUCA code definiti ons were introduced in late

2013 and are based on data from the 2010 decennial census and the 2006-10 American Community Survey. We proposed to adopt the mo st recent modifications of the RUCA codes beginning in CY 2015, to recognize le vels of rurality in census tr acts located in every county across the nation, for purposes of payment unde r the ambulance fee schedule. In the CY 2015 PFS proposed rule (79 FR 40373), we stated that if we adopt the most recent RUCA codes, manyCMS-1612-FC 549

counties that are designated as urban at the county level based on population would have rural

census tracts within them that would be recognized as rura l areas through our use of RUCA

codes. As we stated in the CY 2015 PFS proposed rule (79 FR 40373 through 40374), the 2010 Primary RUCA codes are as follows: (1) Metropolitan area co re: primary flow with an urbanized area (UA). (2) Metropolitan area high commuting: pr imary flow 30 percent or more to a UA. (3) Metropolitan area low commuting: primary flow 10 to 30 percent to a UA. (4) Micropolitan area core: primary flow within an Urban Cluster of 10,000 to 49,999 (large UC). (5) Micropolitan high commuting: primary flow 30 percent or more to a large UC. (6) Micropolitan low commuting: primar y flow 10 to 30 percent to a large UC. (7) Small town core: primary flow w ithin an Urban Cluster of 2,500 to 9,999 (small UC). (8) Small town high commuting: primary flow 30 percent or more to a small UC. (9) Small town low commuting: primary flow 10 to 30 percent to a small UC. (10) Rural areas: primary flow to a tract outside a UA or UC. Based on this classification, and consistent with our current policy (71 FR 69715), we proposed to continue to designate any census tracts falling at or above RUCA level 4.0 as rural areas for purposes of payment for ambulance se rvices under the ambulan ce fee schedule. As discussed in the CY 2007 PFS final rule (71 FR 69715), the Office of Rural Health Policy within

the Health Resources and Services Administratio n (HRSA) determines eligibility for its rural grant programs through the use of the RU CA code methodology. Under this methodology, HRSA designates any census tract that falls in RUCA level 4.0 or higher as a rural census tract.CMS-1612-FC 550

In addition to designating any census tracts fall ing at or above RUCA level 4.0 as rural areas, under the updated RUCA code definitions, HRSA ha s also designated as ru ral census tracts those

census tracts with RUCA codes 2 or 3 that are at least 400 square miles in area with a population density of no more than 35 people. We refer readers to HRSA’s website: ftp://ftp.hrsa.gov/ruralhealth/Eligibility2005.pdf for additional information. Consistent with the HRSA guidelines discussed above, we proposed, beginning in CY 2015, to designate as rural areas (1) those census tracts that fall at or above RUCA level 4.0, a nd (2) those census tracts that

fall within RUCA levels 2 or 3 that are at leas t 400 square miles in area with a population density of no more than 35 people. We stated in th e CY 2015 PFS proposed rule (79 FR 40374) that we continue to believe that HRSA’s guidelines accura tely identify rural cen sus tracts throughout the country, and thus would be appropriate to ap ply for ambulance payment purposes. We invited comments on this proposal. We stated in the CY 2015 PFS proposed rule ( 79 FR 40374) that the a doption of the most current OMB delineations and the updated RUCA codes would affect whet her certain areas are recognized as rural or urban. The distinction be tween urban and rural is important for ambulance payment purposes because urban and rural transports are paid differently. The determination of whether a transport is urban or ru ral is based on the point of pick- up for the transport, and thus a transport is paid differently depe nding on whether the poin t of pick-up is in an urban or a rural area. During claims processing, a geographic de signation of urban, rural, or super rural is assigned to each claim for an ambulance transport ba sed on the point of pick-up ZIP code that is

indicated on the claim. Currently, section 1834(l)(12) of the Act (as amended by section 104(b) of the PAMA) specifies that, for services furnished during the period July 1, 2004 through March 31, 2015, the payment amount for the ground ambulance base ra te is increased by a “percent increase” (SuperCMS-1612-FC 551

Rural Bonus) where the ambulance transport origin ates in a “qualified rural area,” which is a

rural area that we determine to be in the lowest 25 th percentile of all rura l populations arrayed by population density (also known as a “super rural area”). We implement this Super Rural Bonus in §414.610(c)(5)(ii). We stated in the CY 2015 PFS proposed rule (79 FR 40374) that adoption of the revised OMB delineations and the update d RUCA codes would have no negative impact on ambulance transports in super ru ral areas, as none of the current super rural areas would lose their status due to the revised OMB delineations and the updated RUCA codes. As we stated in the CY 2015 PFS proposed ru le (79 FR 40374), the adoption of the new OMB delineations and the updated RUCA codes would affect whether or not transports would be eligible for other rura l adjustments under the ambulance fee schedule statute and regulations. For ground ambulance transports where the point of pick-up is in a rural area, the mileage rate is increased by 50 percent for each of the first 17 miles (§414.610(c)(5)(i)). For air ambulance services where the point of pick -up is in a rural area, the total payment (base rate and mileage rate) is increased by 50 percent (§414.610(c)(5)(i)). Furthermore, under section 1834(l)(13) of the Act (as amended by section 104(a) of the PAMA), for ground ambulance transports furnished through March 31, 2015, transports originating in rura l areas are paid based on a rate (both base rate and mileage rate) that is 3 percent highe r than otherwise is a pplicable. (See also §414.610(c)(1)(ii)). We stated in the CY 2015 PFS proposed rule (79 FR 40374) that if we adopt OMB’s revised delineations and the updated RUCA codes, ambulance providers and suppliers that pick up Medicare beneficiaries in areas that would be Micropolitan or othe rwise outside of MSAs

based on OMB’s revised delineations or in a ru ral census tract of an MSA based on the updated RUCA codes (but are currently within urban areas) may experience increases in payment for such transports because they may be eligible for the rural adjustment factors discussed above,CMS-1612-FC 552

while those ambulance providers and suppliers that pick up Medicare benefi ciaries in areas that

would be urban based on OMB’s revised delin eations and the updated RUCA codes (but are currently in Micropolitan Areas or otherwise outside of MSAs, or in a rural census tract of an MSA) may experience decreases in payment for su ch transports because they would no longer be eligible for the rural adjustme nt factors discussed above.

The use of the revised OMB delineations and the updated RUCA codes would mean the recognition of new urban and rural boundaries ba sed on the population migration that occurred over a 10-year period, between 2000 and 2010. In the CY 2015 PFS proposed rule (79 FR 40374), we stated that, based on the latest United States Postal Service (USPS) ZIP code file, there are a total of 42,914 ZIP c odes in the U.S. We stated in the proposed rule that the geographic designations for approximately 99.48 percent of ZIP codes would be unchanged by OMB’s revised delineations and the updated RUCA codes, and that a similar number of ZIP codes would change from rural to urban (122, or 0.28 percent) as would change from urban to rural (100, or 0.23 percent). We stated in the propos ed rule that, in general, it was expected that ambulance providers and suppliers in 100 ZIP code s within 11 states may experience payment increases if we adopt the revise d OMB delineations and the update d RUCA codes, as these areas would be redesignated from urban to rural. We st ated that the state of Ohio would have the most ZIP codes changing from urban to rural with a tota l of 40, or 2.69 percent. We also stated in the CY 2015 PFS proposed rule that ambulance provide rs and suppliers in 122 ZIP codes within 22 states may experience payment decreases if we adopt the revised OM B delineations and the updated RUCA codes, as these areas would be rede signated from rural to urban. We stated that the state of West Virginia woul d have the most ZIP codes changing from rural to urban (17, or 1.82 percent), while Connecticut would have the gr eatest percentage of ZIP codes changing from rural to urban (15 ZIP codes, or 3.37 percent). Our findings were illustrated in Table 17 of theCMS-1612-FC 553

CY 2015 PFS proposed rule (79 FR 40375). We stated in the CY 2015 PFS proposed rule (79 FR 40375 and 40376) that we believe

the most current OMB statistical area delineatio ns, coupled with the updated RUCA codes, more accurately reflect the contemporary urban and rura l nature of areas across the country, and that

use of the most current OMB delineations a nd RUCA codes under the ambulance fee schedule would enhance the accuracy of ambulance f ee schedule payments. We solicited comments on our proposal to implement the new OMB delineati ons and the updated RUCA codes as discussed above beginning in CY 2015, for purposes of payment under the Medicare ambulance fee

schedule. We received four comments from two associations representing ambulance service providers and suppliers and two ambulance s uppliers on our proposal to implement the new OMB delineations and the updated RUCA codes for purposes of payment under the Medicare

ambulance fee schedule. Those comments ar e summarized below along with our responses. Comment: All of the commenters agreed with CMS that it is appropriate to adjust the geographic area designations period ically so that the ambulance f ee schedule reflects population

shifts. Response: We appreciate the support of the commenters. Comment: Commenters expressed concern that the analysis of the proposed modification in the CY 2015 PFS proposed rule did not describe the actual impact of the proposed change

because it did not take into account the most r ecent modifications to the RUCA codes. When these codes are applied, the commenters stated th at there would be substantially more ZIP codes

that would shift. The commenters estimated th at more than 1,500 ZIP codes would shift from

rural to urban and about three times the number of ZIP codes identified in the proposed rule would change from urban to rural. The comment ers also stated that some ZIP codes would noCMS-1612-FC 554

longer have super rural status. Response: The commenters ar e correct that the analysis published in the CY 2015 PFS proposed rule (see Table 17 (79 FR 40375)) pr esented the impact of the revised OMB delineations only and did not in clude the impact of the updated RUCA codes. We did not receive the ZIP code approximati on of the 2010 RUCA codes file in time to be included in our analysis in the proposed rule. We have completed an updated analysis of both the revised OMB delineations and the updated RUCA codes. Based on the latest United States Postal Service (USPS) ZIP code file, there are a total of 42,918 ZIP codes in the U.S. Based on our updated analysis, we have concluded that the geographic de signations for approximately 92.02 percent of ZIP codes would be unchanged by OMB’s revised delineations and th e updated RUCA codes. There are more ZIP codes that would change from rural to urban (3,038 or 7.08 percent) th an from urban to rural (387 or 0.90 percent). The differences in the data provided in the proposed rule compared to the final rule are due to inclusion of the updated RU CA codes. In general, it is expected that ambulance providers and suppliers in 387 ZIP codes within 41 states , may experience payment

increases under the revised OMB delineations and the updated RUCA codes, as these areas have been redesignated from urban to rural. The st ate of California has the most ZIP codes changing from urban to rural with a total of 43, or 1.58 percent. Ambulance prov iders and suppliers in 3,038 ZIP codes within 46 states and Puerto Ri co may experience payment decreases under the

revised OMB delineations and the updated RUCA codes, as these areas have been redesignated

from rural to urban. The state of Pennsylvania has the most ZIP codes changing from rural to urban (293, or 13.06 percent), whil e West Virginia has the great est percentage of ZIP codes changing from rural to urban (269 ZIP codes, or 28.74 percent). Our findings are illustrated in

Table 47.CMS-1612-FC 555

TABLE 47: Updated ZIP Codes Analysis Based on OMB’s Revised Delineations and Updated RUCA Codes State/ Territory * Total ZIP Codes Total ZIP Codes Changed Rural to

Urban Percentage of Total ZIP

Codes Total ZIP Codes Changed Urban to

Rural Percentage of Total ZIP Codes Total ZIP Codes

Not Changed Percentage of Total ZIP

Codes Not Changed

AK 276 0 0.00% 0 0.00% 276 100.00% AL 854 83 9.72% 8 0.94% 763 89.34% AR 725 41 5.66% 6 0.83% 678 93.52% AS 1 0 0.00% 0 0.00% 1 100.00% AZ 569 21 3.69% 7 1.23% 541 95.08% CA 2723 94 3.45% 43 1.58% 2586 94.97% CO 677 4 0.59% 9 1.33% 664 98.08% CT 445 56 12.58% 0 0.00% 389 87.42% DC 303 0 0.00% 0 0.00% 303 100.00% DE 99 6 6.06% 0 0.00% 93 93.94% EK 63 0 0.00% 0 0.00% 63 100.00% EM 856 71 8.29% 2 0.23% 783 91.47% FL 1513 105 6.94% 9 0.59% 1399 92.47% FM 4 0 0.00% 0 0.00% 4 100.00% GA 1032 101 9.79% 4 0.39% 927 89.83% GU 21 0 0.00% 0 0.00% 21 100.00% HI 143 9 6.29% 3 2.10% 131 91.61% IA 1080 42 3.89% 3 0.28% 1035 95.83% ID 335 3 0.90% 0 0.00% 332 99.10% IL 1628 159 9.77% 7 0.43% 1462 89.80% IN 1000 110 11.00% 7 0.70% 883 88.30% KY 1030 81 7.86% 5 0.49% 944 91.65% LA 739 101 13.67% 1 0.14% 637 86.20% MA 751 14 1.86% 6 0.80% 731 97.34% MD 630 84 13.33% 0 0.00% 546 86.67% ME 505 19 3.76% 12 2.38% 474 93.86% MH 2 0 0.00% 0 0.00% 2 100.00% MI 1185 63 5.32% 13 1.10% 1109 93.59% MN 1043 47 4.51% 7 0.67% 989 94.82% MP 3 0 0.00% 0 0.00% 3 100.00% MS 541 36 6.65% 1 0.18% 504 93.16% MT 411 0 0.00% 3 0.73% 408 99.27% NC 1101 163 14.80% 6 0.54% 932 84.65% ND 419 2 0.48% 0 0.00% 417 99.52% NE 632 7 1.11% 6 0.95% 619 97.94% NH 292 6 2.05% 2 0.68% 284 97.26% NJ 747 1 0.13% 2 0.27% 744 99.60% NM 438 4 0.91% 2 0.46% 432 98.63% NV 257 4 1.56% 2 0.78% 251 97.67%CMS-1612-FC 556

State/ Territory * Total ZIP Codes Total ZIP Codes Changed Rural to

Urban Percentage of Total ZIP

Codes Total ZIP Codes Changed Urban to

Rural Percentage of Total ZIP Codes Total ZIP Codes

Not Changed Percentage of Total ZIP

Codes Not Changed

NY 2246 180 8.01% 42 1.87% 2024 90.12% OH 1487 80 5.38% 34 2.29% 1373 92.33% OK 791 23 2.91% 7 0.88% 761 96.21% OR 495 26 5.25% 9 1.82% 460 92.93% PA 2244 293 13.06% 38 1.69% 1913 85.25% PR 177 21 11.86% 0 0.00% 156 88.14% PW 2 0 0.00% 0 0.00% 2 100.00% RI 91 2 2.20% 1 1.10% 88 96.70% SC 543 91 16.76% 2 0.37% 450 82.87% SD 418 0 0.00% 1 0.24% 417 99.76% TN 814 82 10.07% 12 1.47% 720 88.45% TX 2726 155 5.69% 32 1.17% 2539 93.14% UT 359 2 0.56% 0 0.00% 357 99.44% VA 1277 147 11.51% 13 1.02% 1117 87.47% VI 16 0 0.00% 0 0.00% 16 100.00% VT 309 15 4.85% 0 0.00% 294 95.15% WA 744 29 3.90% 6 0.81% 709 95.30% WI 919 66 7.18% 5 0.54% 848 92.27% WK 711 16 2.25% 5 0.70% 690 97.05% WM 342 4 1.17% 3 0.88% 335 97.95% WV 936 269 28.74% 0 0.00% 667 71.26% WY 198 0 0.00% 1 0.51% 197 99.49% TOTALS 42918 3038 7.08% 387 0.90% 39493 92.02%

* ZIP code analysis includes U.S. States and Territories (FM- Federated States of Micronesia, GU – Guam, MHMarshall Islands, MP-Northern Mariana Islands, PW- Palau, AS- American Samoa; VI- Virgin Islands; PR- Puerto Rico). [ Missouri is divided into east and west regions due to work distribution of the Medicare Administrative Contractors (MACs) : EM- East Missouri, WM – West Mi ssouri. Johnson and Wyandotte counties in Kansas were changed as of January 2010 to East Kansas (EK) and the rest of the state is West Kansas (WK).

As discussed above, in the CY 2015 PFS propos ed rule (79 FR 40374), we proposed to designate as rural those census tr acts that fall in RUCA codes 2 or 3 that are at least 400 square miles in area with a population density of no more than 35 people. However, upon further analysis, we have determined that it is not f easible to implement this proposal. Payment under

the ambulance fee schedule is based on the ZI P codes; therefore, if the ZIP code is predominantly metropolitan but has some rural cen sus tracts, we do not split the ZIP code areas to distinguish further granularity to provide diffe rent payments within the same ZIP code. WeCMS-1612-FC 557

believe that payment for all ambulance transporta tion services at the ZI P code level provides a consistent payment system. Therefore, such census tracts were not consid ered rural areas in the updated analysis set forth above. For more detail on the impact of these cha nges, in addition to Table 47, the following files are available through the Internet on the AFS website athttp://www.cms.gov/Medicare/Medicare-Fee-for-ServicePayment/AmbulanceFeeSchedule/index.html : ZIP codes by state that changed from urban to rural, ZIP codes by state that changed from rura l to urban, list of ZIP codes with RUCA code designations, and a complete list of ZIP codes identifying their de signation as supe r rural, rural

or urban. As reflected in Table 47, our findings are generally consis tent with the commenters’ findings that more than 1,500 ZIP codes would cha nge from rural to urban (our updated analysis indicates that 3,038 ZIP codes are changing), and th at about three times the number of ZIP codes identified in the proposed rule (100) would cha nge from urban to rural (our updated analysis indicates 387 ZIP codes are changing). As we stated in the proposed rule (79 FR 40374), none of the current super rural areas will lose their super rural status upon implementation of the revised OMB delineations and the updated RUCA codes. Comment: One commenter suggested that we delay the implementation of the adjustment until CY 2016 to allow CMS sufficient time to publish the changes in rural and urban

status and allow all interested parties to provide comments on the proposal. In addition to delaying implementation, the comme nter suggested implementing a 4-year transition that would phase-in the payment reduction over a specified peri od for those ZIP codes lo sing rural status. Other commenters requested th at the implementation of the geographic adjustmentsCMS-1612-FC 558

outlined in the proposed rule be delayed until such time as the data is available to complete a full and accurate analysis of the ZIP codes affected an d the financial impact to industry. Absent such a delay, the commenters stated that the final rule must clarify, in a complete and transparent manner, the accuracy of the analysis used in the proposed rule

. Response: We believe that ambulance provide rs and suppliers had sufficient notice of and opportunity to comment on the proposed adop tion of the revised OMB delineations and the updated RUCA codes under the ambulance fee schedul e, and thus we do not believe a delay in implementation is warranted. In the proposed rule, we proposed to adopt the revised OMB

delineations as set forth in OMB Bulletin No. 13-01 and the updated RUCA codes for purposes of payment under the ambulance fee schedule consistent with the policy we implemented in CY 2007 (see the CY 2007 PFS final rule (71 FR 69713 through 69716)). We explained in the proposed rule that the adoption of the revi sed OMB delineations and updated RUCA codes

would affect the urban/rural designation of certain areas, a nd thus would affect whether transports in certain areas w ould be eligible for rural ad justments under the ambulance fee schedule. In addition, OMB Bulletin No. 13-01was available on February 28, 2013, and contained additional information regarding the changes in OMB geographic area delineations. As discussed above, the ZIP code an alysis set forth in the proposed rule reflected the impact of

the revised OMB delineations. The 2010 RUCA codes and definitions were available on December 31, 2013 on the U.S. Department of Agriculture’s Economic Research Service’s website, which provided ambulance providers an d suppliers with additional information regarding changes to the level of rurality in census tracts. Furt hermore, section 1834(l) requires

that we use the most recent modification of the Goldsmith Modification to determine rural census tracts for purposes of certain rural add- ons, and our established policy, as set forth in §414.605, is that rural areas include rural census tracts as determined under the most recentCMS-1612-FC 559

version of the Goldsmith modification. As discussed above and in the CY 2015 PFS pr oposed rule, we believe the most current OMB statistical area delineations, coupled with the updated RUCA codes, more accurately reflect the contemporary urban and rural nature of areas across the country, and thus we believe

the use of the most current OMB delinea tions and RUCA codes under the ambulance fee schedule will enhance the accuracy of ambulance f ee schedule payments. We believe that it is important to use the most current OMB delinea tions and RUCA codes available as soon as reasonably possible to maintain a more accurate and up-to-date payment system that reflects the reality of population shifts. Because we be lieve the revised OMB delineations and updated RUCA codes more accurately identify urban a nd rural areas and enhance the accuracy of the Medicare ambulance fee schedule, we do not belie ve a delay in implementation or a transition period would be appropriate. Areas that lose th eir rural status and become urban have become urban because of recent population shifts. We be lieve it is important to base payment on the most accurate and up-to-date geographic area delineat ions available. Furthermore, we believe a delay would disadvantage the ambulance providers or suppliers experiencing payment increases based on these updated and more accurate OM B delineations and RU CA codes. Finally, given the relatively small percentage of ZIP codes affected by the revised OMB delineations and updated RUCA codes (a total of 3,425 ZIP codes changi ng their urban/rural status out of 42,918 ZIP codes, or 7.98 percent), we do not believe th at a delay is warranted. As commenters requested, we have included in Tabl e 47 our updated analysis of the impact of adopting the revised OMB delineations and the updated RUCA codes.

Comment: One commenter recommended that if any ZIP codes would lose their super rural status as a result of the proposed adopti on of the revised OMB delineations and the updated RUCA codes, then CMS should grandfather th e current super rural ZIP codes. AnotherCMS-1612-FC 560

commenter stated that the a mbulance providers must have ver ifi cation from CMS that the super

rural ZIP codes wi ll not be affected by the changes described in the proposed r ule in advance of

their imp l ementation in the final rule. Response: As we stated pr eviously, the adoption of the OMB’s revised delineations and the updated RUCA codes will have no negative impact on ambulance transports in super rural areas, as none of the current s uper rural areas will lose their status upon implementation of the

revised OMB delineations and the updated RUCA codes. Current areas designated as super rural

areas will continue to be eligible for the super rural bonus.

After consideration of the public comments received, and for the reasons discussed above, we are finalizing our proposals to adopt, beginning in CY 2015, the revised OMB delineations as set forth in OMB’s February 28, 2013 bulletin (No. 13-01) and the most recent modifications of the RUCA codes for purposes of payment under the am bulance fee schedule. As we proposed, using the updated RUCA codes de finitions, we will continue to designate any census tracts falling at or above RUCA level 4.0 as rural areas. However, as discussed above, we are not finalizing our proposal to designate as rural those ce nsus tracts that fall within RUCA codes 2 or 3 that are at least 400 square miles in area with a population de nsity of no more than 35 people. Finally, as discussed ab ove, none of the current super ru ral areas will lose their super rural status upon implementation of the revised OMB delineations and the updated RUCA codes. C. Clinical Laboratory Fee Schedule

In the CY 2014 PFS final rule with comment period (78 FR 74440 through 74445, 74820), we finalized a process under which we w ould reexamine the payment amounts for test codes on the Clinical Laboratory Fee Schedule (C LFS) for possible payment revision based on technological changes beginning with the CY 2015 proposed rule, and we codified this process at §414.511. After we finalized this process, the Congress enacted the PAMA. Section 216 ofCMS-1612-FC 561

the PAMA creates new section 1834A of the Ac t, which requires us to implement a new Medicare payment system for clinical diagnostic laboratory tests based on private payor rates.

Section 216 of the PAMA also resc inds the statutory authority in section 1833(h)(2 )(A)(i) of the Act for adjustments based on technological change s for tests furnished on or after April 1, 2014 (PAMA’s enactment date). As a result of these provisions, we did not propose any revisions to payment amounts for test codes on the CLFS base d on technological changes, and we proposed to remove §414.511. We did not receive any public comments on this proposal. Therefore, we are finalizing our proposal to remove §414.511. In addition, we will establish through rulemaking the parameters for the collection of private payor rate informa tion and other requirements to implement section

216 of the PAMA.CMS-1612-FC 562

D. Removal of Employment Requirements for Se rvices Furnished “Incident to” Rural Health Clinics (RHC) and Federally Qualifie d Health Center (FQHC) Visits 1. Background Rural Health Clinics (RHCs) and Federally Qualified Health Centers (FQHCs) furnish physicians’ services; services and supplies “inc ident to” the services of physicians: nurse practitioner (NP), physician assist ant (PA), certified nurse-midwife (CNM), clinical psychologist (CP), and clinical social work er (CSW) services; and services and supplies incident to the services of NPs, PAs, CNMs, CPs, and CSWs. They may also furnish diabetes self-management training and medical nutrition th erapy (DSMT/MNT), transitional care management services, and in some cases, visiting nurse services furn ished by a registered pr ofessional nurse or a licensed practical nurse. (For additional information on coverage requirements for services furnished in RHCs and FQHCs, see Chapte r 13 of the CMS Benefit Policy Manual.) In the May 2, 2014 final rule with comment pe riod entitled “Prospective Payment System for Federally Qualified Health Centers; Changes to Contracting Policies for Rural Health Clinics; and Changes to Clinical Labor atory Improvement Amendments of 1988 Enforcement Actions for Proficiency Testing Referral” (79 FR 25436), we removed the regulato ry requirements that NPs, PAs, CNMs, CSWs, and CPs furnishing services in a RHC must be employees of the RHC. RHCs are now allowed to contract with NPs, PA s, CNMs, CSWs, and CPs, as long as at least one NP or PA is employed by the RHC, as require d under clause (iii) in th e first sentence of the flush material following subparagraph (K) of section 1861(aa)(2) of the Act. Services furnished in RHCs and FQHCs by nurse s, medical assistants, and other auxiliary personnel are considered “incid ent to” a RHC or FQHC visit furnished by a RHC or FQHC practitioner. Sections 40 5.2413(a)(6), 405.2415(a)(6), and 405.2452( a)(6) currently state that services furnished incident to an RHC or FQHC visit must be furnished by an employee of theCMS-1612-FC 563

RHC or FQHC. Since there is no separate benefit under Medicare la w that specifically authorizes payment to nurses, medical assist ants, and other auxili ary personnel for their professional services, they ca nnot bill the program directly and receive payment for their services, and can only be remunerated when fu rnishing services to Me dicare patients in an “incident to” capacity. To provide RHCs and FQHCs with as much flexibility as possible to meet their staffing needs, we proposed to revise §405.2413(a)(5 ), §405.2415(a)(5) and §405.2452(a)(5) and delete §405.2413(a)(6), §405.2415(a)(6) and §405.2452( a)(6) to remove the requ irement that services

furnished incident to an RHC or FQHC visit must be furnished by an employee of the RHC or FQHC, in order to allow nurses, medical assist ants, and other auxiliary personnel to furnish

“incident to” services under c ontract in RHCs and FQHCs. We believe that removing the requirements will provide RHCs and FQHCs with additional flexibility without adversely impacting the quality or continuity of care. We received 23 comments on our proposal. The following is a summary of the

comments received.

Comment: Most commenters we re strongly in favor of removing these employment requirements. Several commenters stated that this flexibility will assist RHCs and FQHCs in increasing access to care, enable them to recru it highly qualified health professionals, and fill temporary staffing voids without adversely imp acting the quality of car e. Some commenters expressed concerns about maintaining professional standards, and others were concerned about the potential loss of benefits for contracted staff. A few commenters stated that they suppor t removal of the employment requirement, provided that RHC and FQHC auxiliary personne l are held to the same high professional standards for the quality of care, regardless of whether they are working under contract or asCMS-1612-FC 564

employees. Commenters also added that all me mbers of a physician-led health care team should be enabled to perform medical in terventions that they are capab le of performing according to their education, training, li censure, and experience. Response: The proposal to remove the require ment that auxiliary workers in RHCs and FQHCs be employees of the RHC or FQHC does not change either their professional standards of care or their scope of practice. Nurses, medical assistan ts, and other aux iliary personnel are expected to maintain their professional standard s of care and furnish services in adherence to their scope of practice, regardless of whether they are employed or c ontracted by the RHC or FQHC.

Comment: Some commenters st ated that although they unde rstand the need for greater staffing flexibility, they were concerned about the potential loss of benefit packages to

individuals that are contracted and not employed. The commenter s questioned whether the issue was investigated or vetted, and how RHCs a nd FQHCs would compensate for this loss of compensation for individuals providing incident to services under contract rather than as an employee. Response: We appreciate the concern that these commenters raised regarding the potential loss of benefit packages for contra cted individuals; however , we do not regulate employment agreements or benefit packages for individuals working at RHCs and FQHCs.

After consideration of the public comments, we are finali zing this provision as proposed.CMS-1612-FC 565

E. Access to Identifiable Data for the Cent er for Medicare and Me dicaid Innovation Models 1. Background and Statutory Authority

Section 3021 of the Affordable Care Act am ended the Social Secur ity Act to include a new section 1115A, which established the Ce nter for Medicare and Medicaid Innovation (Innovation Center). Section 1115A tasks the Innova tion Center with testing innovative payment and service delivery models that could reduce program expenditures while preserving and/or enhancing the quality of care furnished to indi viduals under titles XVIII, XIX, and XXI of the Act. The Secretary is also required to conduc t an evaluation of each model tested. Evaluations will typically include quantitati ve and qualitative methods to assess the impact of the model on quality of care and heal th care expenditures. To comply with the statutory requirement to evalua te all models conducted under s ection 1115A of the Act, we will conduct rigorous quantitative an alyses of the impact of th e model test on health care expenditures, as well as an assessment of measur es of the quality of care furnished under the model test. Evaluations will also include qual itative analyses to capture the qualitative differences between model participants, and to fo rm the context within which to interpret the quantitative findings. Through the qualitative analyses, we will assess the experiences and perceptions of model particip ants, providers, and individu als affected by the model.

In the evaluations we use advanced statisti cal methods to measure effectiveness. Our methods are intended to provide results that m eet a high standard of evidence, even when randomization is not feasible. To successfully carry out evaluations of Innovation Center models, we must be able to determine specificall y which individuals are r eceiving services from or are the subject of the interven tion being tested by the entity pa rticipating in the model test.

Identification of such individuals is nece ssary for a variety of purposes, including the construction of control groups against which mode l performance can be compared. In addition,CMS-1612-FC 566

to determine whether the observed impacts are du e to the model being tested and not due to differences between the intervention and comp arison groups, our evaluations will have to account for potential confounding factor s at the individual level, wh ich will require the ability to identify every individual associated with the model test, control or comparison groups, and the

details of the intervention at the individual level.

Evaluations will need to consider such fact ors as outcomes, clinical quality, adverse effects, access, utilization, patient and provider satisfaction, sustainability, potential for the model to be applied on a broader scale, and total cost of care. Individu als receiving services from or who are the subjects of the interven tion will be compared to clinically, sociodemographically, and geographically similar matched individuals al ong various process, outcome, and patient-reported measures. Research questions in a typica l evaluation will include, but are not limited to, the following:

● Clinical Quality: ++ Did the model improve or have a negative impact on clinical process measures, such as adherence to evidence-based guidelines? If so, how, how much, a nd for which individuals? ++ Did the model improve or have a negative impact on clinical outcome measures, such as mortality rates, and the incidence and prev alence of chronic conditions? If so, how, how much, and for which individuals? ++ Did the model improve or have a negative impact on access to care? If so, how, how much, and for which individuals? ++ Did the model improve or have a ne gative impact on care coordination among providers? If so, how, how much, and for which individuals? ++ Did the model improve or have a negati ve impact on medication management? If so, how, how much, and for which individuals?CMS-1612-FC 567

● Patient Experience: ++ Did the model improve or have a negative impact on patient-provider communication? If so, how, how much, and for which individuals? ++ Did the model improve or have a negati ve impact on patient experiences of care, quality of life, or functiona l status? If so, how, how muc h, and for which individuals?

● Utilization/ Expenditures:

++ Did the model result in decreased util ization of emergency department visits, hospitalizations, and readmissi ons? If so how, how much, and for which individuals?

++ Did the model result in incr eased utilization of physician or pharmacy services? If so how, how much, and for which individuals?

++ Did the model result in decreased total cost of care? Were cha nges in total costs of care driven by changes in utilization for specific t ypes of settings or health care services? What specific aspects of the model led to these chan ges? Were any savings due to improper costshifting to the Medicaid program? To carry out this research we must have acce ss to patient records not generally available to us. As such, we proposed to exercise our authority in section 1115A(b)(4)(B) of the Act to establish requirements for states and other entities participating in the testi ng of past, present, and

future models under section 1115A of the Act to collect and report information that we have determined is necessary to mon itor and evaluate such models. Thus, we proposed to require model participants, and providers and suppliers working under the models operated by such participants, to produce such individually iden tifiable health information and such other information as the Secretary identifies as bei ng necessary to conduct th e statutorily mandated

research described above. Such research will include the monitoring and evaluation of such models. Further, we view engagement with othe r payers, both public and private, as a criticalCMS-1612-FC 568

driver of the success of these models. CMS pr ograms constitute only a sh are of any provider’s revenue. Therefore, efforts to im prove quality and reduce cost are mo re likely to be successful if efforts are aligned across payers. Section 1115A of the Act specifically a llows the Secretary of Health and Human Services to consider, in se lecting which models to choose for testing,

“whether the model demonstrates effective linkage with other publ ic sector or private sector payers.” Multi-payer models, such as but not li mited to the Comprehensive Primary Care model, will conduct quality measurement acr oss all patients regardless of payer in order to maximize alignment and increase efficiency. Constructi on of multi-payer quality measures requires the ability to identify all individuals subject to the model test rega rdless of payer. In addition, section 1115A also permits the Secret ary to consider models that allo w states to test and evaluate systems of all-payer payment reform for the medi cal care of residents of the state, including dual eligible individuals. Under the State Innovation Model (SIM), the Innovation Center is testing the ability for state governments to accelerate transformation. Th e premise of the SIM initiative is to support Governor-sponsored, multi-payer models that are focused on public and private

sector collaboration to transfor m the state’s payment and delivery system. States have policy and regulatory authorities, as we ll as ongoing relationships with priv ate payers, health plans, and providers that can accelerate delivery system reform. SI M models must impact the preponderance of care in the state and are expected to work with public and private payers to create multi-payer alignment. The evaluation of SIM will include all populations and payers involved in the state initiative, which in many cases includes private payers. The absence of identifiable data from private payers would result in considerab le limitations on the level of evaluation conducted. Therefore, under this authority, we also proposed to require the

submission of identifiable health and utilization in formation for patients of private payers treated by providers/suppliers participating in the tes ting of a model under se ction 1115A of the ActCMS-1612-FC 569

when an explicit purpose of the m odel test is to engage private sector payers. This regulation will provide clear legal author ity for Health Insurance Port ability and Accountability Act (HIPAA) Covered Entities to disclose any requir ed protected health information. Identifiable data submitted by entities partic ipating in the testi ng of models under section 1115A of the Act will meet CMS Acceptable Risks Safeguards (ARS) guidelines. When data is expected to be exchanged over the internet, such exchange wi ll also meet all E-Gov requirements. In accordance with the requirements of the Pr ivacy Act of 1974, upon receipt by CMS or its contractors, these data will be covered under a CMS-established system of records (System No. 09–70–0591), which serves as the Master system for all demonstrations, evaluations, and research studies administered by the Innovation Center. These data will be stored until the evaluation is complete and all necessary pol icy deliberations have been finalized. 2. Provisions of the Proposed Regulations Wherever possible, evaluations will make use of claims, assessment, and enrollment data available through CMS’ existing administ rative systems. However, evaluations will generally also need to include additional data not available through ex isting CMS administrative systems. As such, depending on the particular project, CMS or its cont ractor will require the production of the minimum data ne cessary to carry out the statut orily mandated research work

described in section E.1. of this final rule wi th comment period. Such data may include the identities of the patients served under the model, relevant clinical deta ils about the services furnished and outcomes achieved, and any c onfounding factors that might influence the evaluation results achieved through the delivery of such services. For illustrative purposes, below are examples of some of the types of info rmation that could be re quired to carry out an evaluation, and for which the evaluator would need patient-l evel identifiers.CMS-1612-FC 570

● Utilization data not othe rwise available through exis ting Centers for Medicare & Medicaid Services (CMS) systems.

● Beneficiary, patient, participan t, family, and provider experiences.

● Beneficiary, patient, participant, and pr ovider rosters with identifiers that allow linkages across time and datasets.

● Beneficiary, patient, participant, a nd family socio-demographic and ethnic

characteristics.

● Care management details, such as details regarding the provision of services, payments or goods to beneficiaries, patients, part icipants, families, or other providers.

● Beneficiary, patient, and participant functional status and assessment data.

● Beneficiary, patient, and pa rticipant health behaviors.

● Clinical data, such as, but not limited to lab values and information from EHRs.

● Beneficiary, patient, participant quality data not otherwise av ailable through claims.

● Other data relevant to identified outc omes—for example, participant employment status, participant educational de grees pursued/achieved, and income. We invited public comment on this pr oposal to mandate the production of the individually identifiable information necessary to conduct the statutorily mandated research

under section 1115A of the Act. In addition, we proposed a new subpart K in part 403 to implement section 1115A of

the Act. The following is a summary of the comments we received regarding our proposal to mandate the production of the individually identi fiable information necessary to conduct the statutorily mandated research under section 1115A of the Act.CMS-1612-FC 571

Comment: Commenters consistently recognized the need to evalua te Innovation Center models as an important component of the effort to test new payment and service delivery models. Further, several commenters supported the need for rigorous evaluations that include control groups. One commenter further recommended the Innovation Center make the aggregated deidentified data from evaluations available to external research ers. Although supportive of the

need to evaluate Innovation Cent er models, several commenters st ated the Innovation Center had not sufficiently justified the need for individually identifiable patient information, and suggested aggregate or de-identified data should be suffi cient. One commenter suggested the submission of performance rates, patient outcomes informa tion, and/or composite scores for participating providers instead of individual patient-level data. The commen ter further stated that CMS should not have access to proprietary patient-level data in registries. Some of the commenters stated CMS should publish its evaluation methodol ogies and solicit feedb ack from independent research experts as to the need for patient-level data. Response: We appreciate the commenters ’ support for rigor ous evaluations, and understand the desire for access to the aggregate de -identified data from these evaluations. We always make our data available in accordance with applicable law, HHS and CMS policies, and, where relevant, the availability of funding. Such laws include HIPAA, the Privacy Act, the

Trade Secrets Act and the Freedom of Inform ation Act. With respect to comments recommending the use of aggregate or de-identifie d data instead of individually identifiable data, as we discussed in the preamble of the proposed ru le, we believe individually identifiable data is necessary. As noted in this final rule with co mment and in the preamble of our proposed rule,

evaluations will need to consider such factors as outcomes, clinical quality, adverse effects, access, utilization, patient and provider satisfactio n, sustainability, potential for the model to be applied on a broader scale, and total cost of care. Furthermore, individu als receiving servicesCMS-1612-FC 572

from or who are the subjects of the interven tion will be compared to clinically, sociodemographically, and geographically similar matched individuals al ong various process, outcome, and patient-reported measures. Many of these assessments will require person-level data. We will make use of aggregate information on system performance through the use of provider submitted aggregate performance rates for selected measures, patient outcomes information, and/or composite scores. However, without the ability to identify specifically which beneficiaries are receiving se rvices as a result of the model, the evaluation analyses could include individuals not even subjec t to the intervention, and therefor e, there would be a very real possibility that positive impacts of the model may be diluted a nd unobservable. While aggregate data could be limited to the target population, id entification of which indi viduals are within the target population of the model, are receiving items and services under the model, or are subject to the interventions being tested under the mode l will also allow the evaluators to construct matched comparison groups that look as similar as possible to the in tervention group. The absence of a well-matched comparison group, whic h can only be achieved when individually

identifiable characteristics ar e known, could result in impact es timates that are inaccurate because these impact estimates could be due to differences between the intervention group and the comparison group and not the intervention itself . Further, while we will need to know the identifiers of beneficiaries that are the subject of the model test, the submission of other patientlevel data from proprietary registries would be limited to data necessary to conduct a credible

evaluation. Data on individuals are also needed to assess diff erential impacts among subgroups of beneficiaries to identify who benefits most from the interventi on. We agree it is important to seek expert opinion on the struct ure of our assessment method s, and so these models are developed in concert with and run through our evaluation contractors, which are independent research firms and academic institutions. Where needed, these contractors also reach out toCMS-1612-FC 573

technical expert panels for added guidance. As a result, the design and implementation of these assessments are informed by those with expert ise in health services research, economics, statistics, program evaluation, ep idemiology, and public health. Comment: Although generally s upportive of the need for rigorous evaluations, some commenters worried that any requirement to provide individually id entifiable data for monitoring and/or assessment purposes would impose an undue administrative burden on model participants, and could lead to the need to submit large (and, potential ly, overbroad) amounts of individually identifiable patie nt-level data. A few commente rs suggested that the Innovation Center should first look to other federal governme nt sources before requesting data from model participants. Several commenters noted that it would be costly to produce patient-level data for models with a multi-payer focus, and others stated additional payment should be made to model participants to offset the cost of data reporting. Further, it was suggested that CMS estimate the potential burden and cost on physicians and othe r providers, and if found to be burdensome, give physicians the right to opt out of producing information that may not be available due to cost limitations or other administrative barriers, such as barriers to producing data stored in

electronic health records. Response: We agree that our determination of what data are necessary to evaluate a model should be made taking into consideration the burden and cost associated with collecting and reporting such data, includi ng the complexities associated with abstracting data from

electronic health reco rds. We further agree that in maki ng such determinations, we should take advantage of all existing federal data systems, wherever possible so that we may minimize the

amount of data that we must obtain from model participants. Our regulation will only require that model participants collect and report data as is necessary for monitoring or evaluation; thus, if we do not need the data, we would not seek to collect it from model participants.CMS-1612-FC 574

Reimbursement may be considered for fu ture models, but if adopted, any such reimbursement, and any conditions for such reim bursement, would be prominently noted in the solicitation or modifications to model agreements. To the extent feasible, we also agree that it is important for potential model participants to und erstand the data collection requirements before the model begins, so that they may take these re quirements into consideration. We do not agree, though, that model participants should be give n the opportunity to opt out of producing the required information, as this would undermin e the evaluation and skew results. With respect to the specific data needed for evaluation purposes, in many models, the

evaluators will be able to determine who the indi viduals are that are the subjects of the model

test without the need to obtain id entifiers from the model participan ts. In those cases, there is a beneficiary-specific payment under the model and the evaluator can use our existing administrative data systems to identify which beneficiaries are in the model. In this last example, although we may not need to obtain the id entifiers, we may still need to obtain other person-level data, such as clinical information. In other models, wher e a specific beneficiarylevel payment is not being made, the evaluation cont ractor will not have an ability to identify the individuals targeted by the model participants. In this latter circumstance , the participants will need to provide the identifiers that would then be used by the evalua tor to link to existing administrative data systems. Although the exact data needs will vary by model, in some cases we would determine that only the identifiers (s uch as, but not limited to, the Medicare Health Insurance Claim number) are require d. In other circumstances, it is possible the evaluators will need other data, such as clinical data not otherwise available in claims to properly account for severity of disease. In this manner we will lim it data demands, and the attendant costs, to the data necessary to accomplish the requ ired monitoring and assessment.CMS-1612-FC 575

Comment: Some comment ers stated the requirement coul d result in requests for data from providers tangentially i nvolved in an Innovation Center project to report any data the agency decides it needs. A few commenters furt her stated the Innovation Center should ensure that all participating entities seek patient author izations to use their r ecords for the purpose of evaluating the model. Response: Section 1115A(b)(4) of the Act authorizes us to establish requirements for “States and other entities participating in the testing of models” to collect and report data necessary for monitoring and evaluating the models . Our regulation, therefore, establishes this requirement only with respect to model participants. We consider model participants to include any party that has agreed to par ticipate in, or that receives pa yment from us under, a model we are testing. In response to the comment suggest ing that the Innovation Ce nter ensure that all participating entities seek patient authorizations to use their records for the purpose of evaluating the model, we decline to impose such a requir ement in implementing section 1115A(b)(4) of the Act, and we refer such entities to their own legal counsel for advice on whether any form of consent would be required by other applicable law.

Comment: Some commenters stated the Innovation Cent er should publish and be transparent about what the exact data reporting and collection requirement s would be so that participants would have notice of what data they would be required to collect. Commenters stated that without a notice and comment period as part of the model test, there will be no opportunity for stakeholders to weigh in with th eir perspective of what constitutes the minimum necessary information to achieve the evaluation goals. A few commenters stated the Innovation Center should first determine the specific data el ements that are required for evaluation purposes for the existing programs and this information shoul d be shared with participants who should, at minimum, be given an opportunity to provide comment on the required inputs for which theyCMS-1612-FC 576

will be responsible as part of the evaluation. These commenters also stated the Innovation Center should develop such requi rements in advance of the progr am start for participants to allow them an opportunity to provide feedback and weigh the informati on as part of their decision to participate in the model. Response: We agree it is impor tant to restrict data reques ts to the data necessary to conduct credible monitoring and evaluation. We fr equently provide stakeholders the opportunity to weigh in on what data they believe would be necessary to evaluate a model, generally through webinars that we conduct during model developmen t and implementation. Further, in order for potential model participants to understand the likely data reporti ng requirements, to the extent feasible, these requirements are in corporated into the solicitation process. However, we decline to adopt a requirement to undertak e a notice and comment process as part of our determination of what data are necessary for monitoring or evalua tion because we believe the process already in place allows for model participant feedback. We also disagree with commenters who recommend that we make the determination and speci fy the particular data elements that will be required for monitoring and evaluation prior to the start of the model. It is not always possible at that early stage of the model to know precisely wh at data elements will be necessary. However, we will strive to provide as much relevant de tail as possible about data collection and reporting requirements in any solicitation process and in any ongoing communications with potential participants, and we will continue to take a ny comments received into account in determining

our data needs.

Comment: A few commenters stated that CM S has not provided sufficient assurances that providers, in responding to these data reque sts, would be protected or deemed to be in compliance with the HIPAA requirements for th e use and disclosure of protected health information (PHI). These commenters stated the Innovation Center re ference to requiringCMS-1612-FC 577

reporting of individually identifi able patient-level data raises significant privacy concerns for providers who would be required to report such data. These co mmenters stated HIPAA requires that providers limit the use and disclosure of personal health information to the minimum necessary to accomplish the intended purpose of the disclosure. These commenters stated the Innovation Center requests for such data must be in compliance with providers’ HIPAA obligations. As such, some commenters stated CMS should work with the Office for Civil Rights (OCR) to ensure providers reporting data as part of an ev aluation are doing so consistent with their HIPAA obligations. These commenter s stated it is HHS’s Office for Civil Rights (OCR) – not CMS – that ultimately determines whether a particular provider is properly compliant and not subject to penalties. Thes e same commenters suggested that the Innovation Center should work with OCR to issue OCR guida nce stating that provide rs reporting data as part of an evaluation are doing so consistent w ith their HIPAA obligati ons. Some commenters stated CMS should consider the necessary data elements on a program-by-program basis rather than establishing a blanket a pproval, or at minimum limit th e scope of the approved data requirements and uses, and should provide clear instructions and other educational resources to ensure that collection and repor ting of the data complies with the HIPAA Privacy and Security

rules. Response: We appreciate the concerns e xpressed about compliance with the HIPAA requirements and the recommendation to work with OCR. However, we respectfully disagree that sufficient assurances have not been pr ovided. The disclosure would be required by a regulation, so it would be “required by law” under HIPAA. See 45 CFR 164.512(a) and the definition of “required by law” at 45 CFR 164.10 3. A HIPAA covered entity is permitted to disclose protected health information as requi red by law under these provisions so long as the disclosure complies with and is limited to the relevant requirements of the law. A separateCMS-1612-FC 578

minimum data necessary determination is not required under the HIPAA Privacy Rule for required by law disclosures unde r 45 CFR 164.512(a). See 45 CF R 164.502(b) (2). Although a separate minimum data necessary determination is not required, as a polic y matter and consistent with the statutory authority under 1115A(b) (4), CMS will only require that data we determine is necessary for evaluation and monito ring of Innovation Center models.

Comment: Several commenters stated that collection of beneficiary-level health information raises significant security concerns. Although supportive of sharing relevant and medically necessary patient information, one comme nter raised a particular concern that some

data could be sensitive information related to mental health or substance abuse. Some commenters stated CMS should adopt safeguards ag ainst inappropriate us e or disclosure of patient identifiable data. Response: We agree that it is critical to ab ide by rigorous security standards, and we take patient privacy seriously. As CMMI is part of Fee-for-Service Medicare, a Health Care Component that is subject to the HIPAA requi rements, providers’ a nd suppliers’ data will generally be subject to the same HIPAA privacy and security requirements as that data was subject to in the hands of the providers and supplie rs from which it came. Furthermore, if stored in a manner searchable by individual identifiers, it will also be subject to the Privacy Act of

1974. As HIPAA Business Associates, this data will be equally well protected when held by

one of our evaluation contractors. In addition, the disclosure of substance abuse records will, where applicable, also be subj ect to the Part 2 regulations.

Comment: One commenter stated CMS should no t use these data for purposes other than those articulated in the propos ed rule, and that the assessm ents should comply with the applicable statutory requirements, meaning tha t: (1) The assessments should take into accountCMS-1612-FC 579

all of the factors outlined under section 1115A(b)(4) of the Act (that is, quality of care, including patient-level outcomes and patient-centeredness cr iteria); (2) the assessments should be made publicly available; and (3) CMS should pursue notice-and-comment rulemaking before any of the CMS demonstrations are expanded based on these assessments, as required by section 1115A(c) of the Act. Response: We agree that ev aluations should assess quality of care, and the patient-deidentified results should be made publicly avai lable, as required by section 1115A(b)(4) of the Act. We would pursue model expansion according to the terms of the statute.

After consideration of the public comments we received, we are finalizing our proposal to mandate the production of the individually identi fiable information necessary to conduct the statutorily mandated research under section 1115A of the Ac t. We are accepting the recommendations made by commenters to mini mize participant burden, seek input from providers, and use independent rese archers. In addition, we are fi nalizing our proposal to add a new subpart K in part 403 to implement sec tion 1115A of the Act without modification.CMS-1612-FC 580

F. Local Coverage Determination Process fo r Clinical Diagnostic Laboratory Testing The CY 2015 proposed rule (79 FR 40378 through 40380), section III.F., included discussion of a proposal to modi fy the existing process used by the Medicare Administrative Contractors (MACs) in developing local coverage determinations (LCDs) for clinical diagnostic laboratory tests. Briefly, th e proposal would have expedited the timeline for LCD development for clinical diagnostic laboratory test LCDs by reducing the calenda r days for some of the steps and by making optional or eliminating other step s within the current process. A detailed discussion of the proposal is available in sec tion III.F. of the CY 2015 PFS Proposed Rule. We would like to thank the numerous public commenters for their time in submitting thoughtful comments to the agency on this issu e. Comments were received from individual members of the public, insurers, drug manufacturer s, medical specialty societies, laboratory groups and individual laboratories. The comme nters focused their comments on the following issues: the proposal to reduce the draft LCD public comment peri od to 30 days; the proposal for a meeting of the Carrier Advisory Committee to be optional; the proposal to remove the requirement for a public meeting; and the proposal to eliminate the 45-day notice period prior to final LCDs becoming effective. In addition, commenters were concerned about the proposed changes in light of section 216 of the Protec ting Access to Medicare Act of 2014 (PAMA), titled “Improving Medicare Policies for Clinical Diagnostic Laboratory Tests.” The comments received have give n the agency much to consider prior to moving forward with any changes to the LCD process; therefore, we will not finalize any changes to the LCD process in this final rule. We will explore the possibi lity of future notice-and-comment rulemaking on

this issue.CMS-1612-FC 581

G. Private Contracting/Opt-out 1. Background Effective January 1, 1998, sect ion 1802(b) of the Act perm its certain physicians and practitioners to opt-out of Medi care if certain conditions are met, and to furnish through private

contracts services that would otherwise be covered by Medica re. For those physicians and practitioners who opt-out of Medicare in acco rdance with section 1802(b) of the Act, the mandatory claims submission and limiting charge rules of section 1848(g) of the Act would not apply. As a result, if the conditions necessary for an effective opt-out are met, physicians and practitioners are permitted to privately contract with Medicare beneficiaries and to charge them without regard to Medicare’s lim iting charge rules. Regulations governing the requirements and procedures for private contracts a ppear at 42 CFR part 405, subpart D. a. Opt-out Determinations (§405.450) The private contracting re gulation at §405.450 describes cert ain opt-out determinations made by Medicare, and the process that physicians , practitioners, and bene ficiaries may use to appeal those determinations. Section 405.450(a) de scribes the process ava ilable for physicians or practitioners to appeal Me dicare enrollment determinations related to opting out of the program, and §405.450(b) describes the process avai lable to challenge payment determinations related to claims for services furnished by physicia ns who have opted out. Both provisions refer to §405.803, the Part B claims appeals process th at was in place at the time the opt-out regulations were issued (Novemb er 2, 1998). When those regulati ons were issued, a process for a physician or practitioner to app eal enrollment related decisions had not been implemented in regulation. Thus, to ensure an appeals process was available to physicians and practitioners for opt-out related issues, we chose to utilize th e existing claims appeals process in §405.803 for both enrollment and claims related appeals.CMS-1612-FC 582

In May 16, 2012 Federal Register (77 FR 29002), we publishe d a final rule entitled “Medicare and Medicaid Program; Regulatory Provisions to Promote Program Efficiency, Transparency and Burden Reduction.” In that fi nal rule, we deleted the provisions relating to initial determinations, appeals, and reopenings of Medicare Part A and Part B claims, and relating to determinations and appeals regardi ng an individual’s entitlement to benefits under Medicare Part A and Part B, which were cont ained in part 405, subpa rts G and H (including §405.803) because these provisions were obsolete a nd had been replaced by the regulations at part 405, subpart I. We inadvertently neglected to revise the cross-re ference in §405.450(a) and (b) of the private contracting regulations to dir ect appeals of opt-out determinations through the current appeal process. However, it is important to note that our policy regarding the appeal of opt-out determinations did not change when the appeal regulations at part 405, subpart I were

finalized. The procedures set forth in current part 498 establish the appeals procedures regarding decisions made by Medicare that affect enrollment in the program. We believe this process, and not the appeal process in part 405, subpart I, is the appropriate cha nnel for physicians and practitioners to challenge an en rollment related opt-out decision made by Medicare. There are now two different sets of appeal regulations for initial determinati ons; and the appeal of enrollment related opt-out determinations is more like the types of determ inations now addressed under part 498 than those under pa rt 405, subpart I. Specifically, the appeal process under part 405, subpart I focuses on reviews of determina tions regarding beneficiary entitlement to

Medicare and claims for benefits for particular services. The appeal process under part 498 is focused on the review of determinations regard ing the participation or enrollment status of providers and suppliers. Enrollment related opt-o ut determinations invo lve only the status of particular physician or practiti oners under Medicare, and do not i nvolve beneficiary eligibility orCMS-1612-FC 583

claims for specific services. As such, the appeal process under part 498 is better suited for the

review of enrollment related opt-out determinations. However, we do not believe the enrollment app eals process established in part 498 is the appropriate mechanism for challenging payment d ecisions on claims for services furnished by a physician and practitioner who has opted out of the program. Appeals for such claims should continue to follow the app eals procedures now set forth in part 405 subpart I. b. Definitions, Requirements of the Opt Out Affidavit, Effects of Opting Out of Medicare, Application to Medicare Advantage C ontracts (§§405.400, 405.420(e), 405.425(a), and 405.455)

Section 405.400 sets forth certain definitions for purposes of the private contracting regulations. Among the defined terms is “Eme rgency care services” which means services

furnished to an individual for treatment of an “emergency medical condition” as that term is defined in §422.2. The cross-referenced regula tion at §422.2 included within the definition of emergency care services was deleted on June 29, 2000 (65 FR 40314) and at that time we inadvertently neglected to revise that cross-reference. The cro ss-reference within the definition of emergency care services should have been ame nded at that time to c ite the definition of “emergency services” in §424.101. The private contracting regulations at §405.420(e), §405.425(a) and §405.455 all use the term Medicare+Choice when referring to Part C plans. However, we no longer use the term Medicare+Choice when referring to Part C plans; instead the plan s are referred to as Medicare Advantage plans. When part 422 of th e regulations was updated on January 28, 2005 (70 FR 4741), we inadvertently neglecte d to revise §405.420(e), §405.425(a) and §405.455 to replace the term Medicare+Choice w ith Medicare Advantage plan. 2. Provisions of the Proposed RegulationCMS-1612-FC 584

For the reasons discussed above, we propos ed that a determination described in §405.450(a) (relating to the status of opt-out or private c ontracts) is an ini tial determination for purposes of §498.3(b), and a physician or practiti oner who is dissatisfied with a Medicare determination under §405.450(a) may utilize the enrollment appeal s process currently available for providers and suppliers in part 498. In a ddition, we proposed that a determination described in §405.450(b) (that payment cannot be made to a beneficiary for services furnished by a physician or practitioner who has opted out) is an initial determination for the purposes of §405.924 and may be challenged through the existi ng claims appeals procedures in part 405 subpart I. Accordingly, we proposed that the cross reference to §405.803 in §405.450(a) be replaced with a cross reference to §498.3(b). We also proposed that the cross reference to §405.803 in §405.450(b) be replaced with a cross reference to §405.924. We also proposed corresponding edits to §498.3(b) and §405.924 to not e that the determinations under §405.450(a) and (b), respectively, are initial determinations. For the reasons discussed above, we also pr oposed that the definition of Emergency care services at §405.400 be revised to cite the defi nition of Emergency serv ices in §424.101 and that all references to Medicare+Choice in §405.420( e), §405.425(a) and §405.455 be replaced with the term “Medicare Advantage.” The following is a summary of the comment s we received regarding our proposals. Comment: Commenters requested that physicians and practitioners be allowed to opt out of Medicare indefinitely instead of submitting a new affidavit every 2 years. Response: These comments are outside the scope of this rule as they are not related to the proposed changes to the opt-out regulati ons. Nevertheless, we note that section 1802(b)(3)(B)(ii) of the Act specifies that the op t-out affidavit must pr ovide that the “physician or practitioner will not submit any claim under this title for any item or service provided to anyCMS-1612-FC 585

medicare beneficiary... during the 2- year period beginning on the date the affidavit is signed.” As such, the longest interval for which an opt-o ut can be effective is 2 years. We have no authority to modify that statutory requirement. Because we did not receive any comments on ou r proposals, we are finalizing the rule as proposed.

H. Solicitation of Comments on the Payment Policy for S ubstitute Physician Billing Arrangements 1. Background In accordance with section 1842(b)(6) of th e Act, no payment under Medicare Part B may be made to anyone other than to the benefici ary to whom a service wa s furnished or to the physician or other person who furnished the se rvice. However, there are certain limited exceptions to this general prohibition. For exam ple, section 1842(b)(6)(D ) of the Act describes an exception for substitute physician billing arra ngements, which states that “payment may be made to a physician for physicians’ services (and services furnished incide nt to such services) furnished by a second physician to patients of th e first physician if (i) the first physician is unavailable to provide the services; (ii) the se rvices are furnished pursuant to an arrangement between the two physicians that (I) is informal and reciprocal, or (II) involves per diem or other fee-for-time compensation for such services; (iii ) the services are not provided by the second physician over a continuous pe riod of more than 60 days or are provided over a longer continuous period during all of whic h the first physician has been called or ordered to active duty as a member of a reserve component of the Arme d Forces; and (iv) the claim form submitted to the [Medicare Administrative contractor (MAC)] for such services includes the second physician’s unique identifier . . . and indicates that the claim meets the requirements of thisCMS-1612-FC 586

subparagraph for payment to th e first physician.” Section 18 42(b)(6) of the Act is selfimplementing and we have not interpreted th e statutory provisions through regulations. In practice, section 1842(b)(6)(D ) of the Act generally allows for two types of substitute physician billing arrangements: (1) an inform al reciprocal arrangement where doctor A

substitutes for doctor B on an occasional basi s and doctor B substitutes for doctor A on an occasional basis; and (2) an arrangement where th e services of the substi tute physician are paid for on a per diem basis or according to the amount of time worked. Substitute physicians in the second type of arrangement are sometimes referred to as “locum tenens” physicians. It is our understanding that locum tenens physicians are substitute phys icians who often do not have a practice of their own, are geographically mobile, and work on an as-needed basis as independent contractors. They are utilized by physician practices, hospitals, and health care entities enrolled in Part B as Medicare suppliers to cover for physicians who ar e absent for reasons such as illness, pregnancy, vacation, or continuing medical education. Also, we have heard anecdotally that locum tenens physicians are used to fill st affing needs (for example, in physician shortage areas) or, on a temporary basis, to replace physic ians who have permanently left a medical group or employer. We are concerned about the operational and prog ram integrity issues that result from the use of substitute physicians to fill staffing need s or to replace a physic ian who has permanently left a medical group or employer. For example, although our Medicare en rollment rules require physicians and physician groups or organizations to notify us promptly of any enrollment changes (including reassignment changes) (see §424.516(d)), processing delays or miscommunication between the departing physicia n and his or her former medical group or employer regarding which party would report the ch ange to Medicare coul d result in the Provider Transaction Access Number (PTAN) that links th e departed physician and his or her formerCMS-1612-FC 587

medical group remaining “open” or “attached” for a period of time. During such period, both the departed physician and the departed physician’ s former medical group might bill Medicare under the departed physician’s National Provider Identifi er (NPI) for furnished services. This could occur where a substitute physician is furnishing se rvices in place of the de parted physician in the departed physician’s former medical group, whil e the departed physician is also furnishing

services to beneficiaries follo wing departure from the former group. Operationally, either or both types of claims could be rejected or deni ed, even though the claims filed by the departed physician were billed appropriatel y. Moreover, the continued use of a departed physician’s NPI

to bill for services furnished to beneficiaries by a substitute physician raises program integrity issues, particularly if the departed physician is unaware of his or her former medical group or employer’s actions. Finally, as noted above, secti on 1842(b)(6)(D)(iv) of the Act requires th at the claim form submitted to the MAC include the substitute physician’s unique identifier. Currently, the unique identifier used to identify a phys ician is the physician’s NPI. Pr ior to the implementation of the NPI, the Unique Physician Identification Numb er (UPIN) was used. Because a substitute physician’s NPI is not captured on the CMS-1500 claim form or on the appropriate electronic claim, physicians and other entities that furnis h services to beneficiaries through the use of a substitute physician are required to enter a modifier on the CMS-1500 claim form or on the appropriate electronic claim indicat ing that the services were furn ished by a substitute physician; and to keep a record of each service provided by the substitute physician, associated with the substitute physician’s UPIN or NPI; and to make this record available to the MAC upon request. (See Medicare Claims Processing Manual (Pub. 100-4), Chapter 1, Sections 30.2.10 and 30.2.11) However, having a NPI or UPIN does not necessa rily mean that the substitute physician is enrolled in the Medicare program. Without bei ng enrolled in Medicare, we do not know whetherCMS-1612-FC 588

the substitute physician has the proper credentials to furnish the services being billed under section 1842(b)(6)(D) of th e Act or if the substitute physicia n is sanctioned or excluded from Medicare. The importance of enrollment and the resulting transparency afforded the Medicare program and its beneficiaries wa s recognized by the Congress when it included in the Affordable Care Act a requirement that physicians and ot her eligible non-physicia n practitioners (NPPs) enroll in the Medicare program if they wish to order or refe r certain items or services for Medicare beneficiaries. This includes those phys icians and other eligible NPPs who do not and will not submit claims to a Medicare contractor for the services they furnish. We solicited comments regarding how to achieve similar transp arency in the context of substitute physician billing arrangements for the identity of the individual actually furn ishing the service to a beneficiary. 2. Analysis of Comments To help inform our decision whether and, if so, how to address the issues discussed in section III.H.1., and whether to adopt regulations interpreting s ection 1842(b)(6)(D) of the Act, we solicited comments on the policy for substitute physician billing arrangements. We noted that any regulations would be proposed in a future rulemaking with opportunity for public comment. Through this solicitation, we hoped to understand better current industry practices for the use of substitute physicians and the impact that policy changes limiting the use of substitute physicians might have on benefici ary access to physician services.

We received a few comments on the issues ra ised in this solicitation. We thank the commenters for their input, and we will careful ly consider their comments in any future rulemaking on this subject.CMS-1612-FC 589

I. Reports of Payments or Other Tran sfers of Value to Covered Recipients 1. Background In the February 8, 2013 Federal Register (78 FR 9458), we published the “Transparency Reports and Reporting of Physician Ownership or Investment Interest s” final rule which implemented section 1128G of the Social Security Act (“Act”), as added by section 6002 of the Affordable Care Act. Under section 1128G(a)(1) of the Act, manufacturers of covered drugs, devices, biologicals, and medical supplies (applic able manufacturers) are required to submit on an annual basis information about certain paym ents or other transfers of value made to physicians and teaching hospitals (c ollectively called covered recipi ents) during the course of the preceding calendar year. Section 1128G(a)(2) of th e Act requires applicable manufacturers and applicable group purchasing organi zations (GPOs) to disclose any ownership or investment

interests in such enti ties held by physicians or their immediate family members, as well as information on any payments or other transfers of value provided to such physician owners or investors. The implementing regulations are at 42 CFR part 402, subpart A, and part 403, subpart I. We have orga nized these reporting requireme nts under the “Open Payments”

program. The Open Payments program creates tran sparency around the nature and extent of relationships that exist between drug, device, biologicals and me dical supply manufacturers, and physicians and teaching hospitals (covered recipi ents and physician owner or investors). The implementing regulations, which describe pro cedures for applicable manufacturers and applicable GPOs to submit electronic reports deta iling payments or other transfers of value and ownership or investment interests provided to covered recipients and physician owners or investors, are codified at §403.908.CMS-1612-FC 590

Since the publication and implementation of the February 8, 2013 final rule, various stakeholders have provided feedback to CMS regarding certain aspects of these reporting requirements. Specifically, §403.904(g)(1) excludes the reporting of paymen ts associated with certain continuing education events, and §403.904(c)(8 ) requires reporting of the marketed name for drugs and biologicals but makes reporting the ma rketed name of devices or medical supplies optional. We proposed a change to §403.904(g) to correct an unintended consequence of the current regulatory text. A dditionally, at §403.904(c)(8), we proposed to make the reporting requirements consistent by requiri ng the reporting of the marketed name for drugs, devices, biologicals, or medical supplies whic h are associated with a payment or other transfer of value. Additionally, at §403.902, we proposed to rem ove the definition of a “covered device” because we believe it is duplica tive of the definition of “covered drug, device, biological or medical supply” which is codified in the same s ection. We also proposed to require the reporting of the following distinct forms of payment: stock; stock option; or any ot her ownership interests specified in §403.904(d)(3) to collect more specific data regarding the forms of payment. 2. Continuing Education Exclusion (§403.904(g)(1)) In the February 8, 2013 final rule, many co mmenters recommended that accredited or certified continuing education payments to spea kers should not be reported because there are safeguards already in place, and th ey are not direct payments to a covered recipient. In the final rule preamble, we noted that “industry support fo r accredited or certified continuing education is a unique relationship” (78 FR 9492). Section 403.904(g)(1) states that payments or other transfers of value provided as compensation for speaking at a continuing education program need not be reported if the followi ng three conditions are met:

● The event at which the covered recipient is speaking must meet the accreditation or certification requirements and standards for c ontinuing education for one of the followingCMS-1612-FC 591

organizations: the Accreditation Council fo r Continuing Medical E ducation (ACCME); the American Academy of Family Physicians ( AAFP); the American Dental Association’s Continuing Education Recognition Program (ADA CERP); the American Medical Association (AMA); or the American Oste opathic Association (AOA).

● The applicable manufacturer does not pay the covered recipient speaker directly.

● The applicable manufacturer does not select the covered recipien t speaker or provide the third party (such as a continuing educati on vendor) with a distinct , identifiable set of individuals to be considered as speakers for the continuing edu cation program. Since the implementation of §403.904(g)(1), other accredi ting organizations have requested that payments made to speakers at th eir events also be exempted from reporting. These organizations have stated that they follow the same accreditation standards as the organizations specified in §403.904( g)(1)(i). Other stakeholders have recommended that the exemption be removed in its entirety stating rem oval of the exclusion will allow for consistent reporting for compensation provided to physician speak ers at all continuing education events, as well as transparency regarding compensation pa id to physician speakers. Many stakeholders raised concerns that the reporting requirements are inconsistent because certain continuing education payments are reportable, while others are not. CMS’ apparent endorsement or support to organizations sponsoring continuing educati on events was an unintended consequence of the

final rule. After consideration of these comments, we proposed to remove the language in §403.904(g) in its entirety, in part because it is redundant with the exclusion in §403.904(i)(1). That provision excludes indirect payments or other transfers of value where the applicable manufacturer is “unaware” of, that is, “does not know,” the identity of the covered recipient during the reporting year or by th e end of the second quarter of the following reporting year.CMS-1612-FC 592

When an applicable manufacturer or applicable GPO provides funding to a continuing education provider, but does not either sele ct or pay the covered recipient speaker directly, or provide the continuing education provider with a distinct, identifiable set of cove red recipients to be considered as speakers for the continuing education program, CMS will consider those payments to be excluded from reporting under §403.904(i)(1). This approach is consistent with our discussion in the preamble to the final rule, inwhich we explained that if an applicable manufacturer conveys “full discretion” to the co ntinuing education provider, those payments are outside the scope of the rule (78 FR 9492). In contrast, for example, when an applicable

manufacturer conditions its fi nancial sponsorship of a con tinuing education event on the participation of particular covere d recipients, or pays a covered re cipient directly for speaking at such an event, those payments are subject to disclosure. We considered two alternative approaches to address this issue. First, we explored expanding the list of organizati ons in §403.904(g)(1)(i) by name; how ever, we believe that this approach might imply CMS’s endorsement of the named continuing education providers over others. Second, we considered expansion of the organizations in §403.904(g)(1)(i) by articulating accreditation or certif ication standards that would allow a CME program to qualify for the exclusion. This approach is not easily implemented because it would require evaluating both the language of the standards, as well as the enforcement of the standards of any organization professing to meet the criteria. We solicited comments on both alternatives presented, including commenters’ suggestions about what standards, if any, CMS should incorporate. The following is summary of the comments we received regarding both alternatives presented, and what standards, if any, CMS should incorporate.

Comment: We received numerous comments addressing our proposal to remove theCMS-1612-FC 593

exclusion for compensation for speaking at a co ntinuing education program. Some comments were in support to remove the exclusion stati ng it is an important step toward ensuring transparency. Supporting comments also agreed removing the exclusion will level the playing field with the medical education community. Nu merous commenters ques tioned our proposal to remove the exclusion for compensation for sp eaking at a continuing education program. Commenters provided background regarding accr editing continuing education organizations stating that creating continuing education accred itation standards is a function of professional self-regulation and additi onal government regulation is not necessary. Many commenters recommend modifying the indi rect payment exclusion currently at § 403.904(i)(1) to specify a contin uing education indirect paymen t should be excluded if the manufacturer did not know the identity of the covered recipient before providing the payment to a third party, such as a continuing education orga nization. This differs from the current indirect payment exclusion language which states the paym ent is excluded if the manufacturer did not know the identity of the covered recipient during the re porting year or by th e end of the second quarter of the following reporting ye ar. Commenters stated it is not practical for a manufacturer to not know the identity of a physician speaker receiving co mpensation for speaking at a continuing education event during the reporting year or by the end of the second quarter of the following reporting year because manufacturers coul d learn the identities of physician speakers through brochures, programs and other publications . Therefore, commenters assert that the indirect payment exclusion is not applicable to exclude compensation provide d to physicians at a continuing education event and recommend the i ndirect payment exclusion is modified to accommodate indirect payments provided to a physician covered recipient through a continuing medical education organization. Additionally, commenters suggested an alte rnative approach where CMS would adoptCMS-1612-FC 594

established criteria, such as the Standards for Commercial Support: Standards to Ensure Independence in CME Activities, in order to have payments provided to physicians at continuing

education events excluded. Similar criteria s uggested by commenters to modify the exclusion were: does not pay covered speakers or attendees directly, does not se lect covered recipient speakers or provide a third party with a distinct, identifiable set of individuals to be considered as speakers or attendees for the continuing educa tion program, and does not control the continuing education program content. Response: We appreciate commenters support to remove the exclusion for compensation for speaking at a continuing education program. We appreciate the comments stating that continuing medical education accrediting organizat ions is a function of professional selfregulation. We believe creating consistent reporting requirement s for all continuing education events, by removing the language in §403.904(g) in its entirety, will provide enhanced regulatory clarity for stakeholders. Manuf acturers reporting compensation pa id to physician speakers may opt to distinguish if the payment was provided at an accredited or certifie d continuing education program versus an unaccredited or non-certified con tinuing education prog ram by selecting the appropriate nature of paym ent category at §403.904(e).

We understand commenters concern regarding learning th e identity of the physician during the reporting year or by the end of the second quarter of the fo llowing reporting year. In the situation of an applicable ma nufacturer providing an indir ect payment through a continuing education organization and learning the identity of the physician covered recipient in the allotted timeframe (during the reporting year or by the end of the s econd quarter of the following reporting year) the indirect payment would not meet the criteria of the indirect payment exclusion and would need to be reported. Howe ver, payments or other transfers of value, including payments made to phys ician covered recipients for pur poses of attending or speakingCMS-1612-FC 595

at continuing education events, which do not meet the definition of an indirect payment, as defined at §403.902, are not reportable. For example, if an applicable manuf acturer or applicable GPO provides funding to support a continuing edu cation event but does notrequire, instruct, direct, or otherwise cause the continuing educat ion event provider to provide the payment or

other transfer or value in whole or in part to a covered recipien t, the applicable manufacturer or applicable GPO is not required to report the payment or other transf er of value. The payment is not reportable regardless if the a pplicable manufacturer or applicable GPO learns the identity of the covered recipient during th e reporting year or by the end of the second quarter of the following reporting year because the payment or other transfer of value did not meet the definition of an indirect payment. This approach is also consistent with our statement at (78 FR 9490), where we explained that “if an applicable manufacturer provided an unrestricted donation to a physician professional organization to use at the organization’s discretion, and the organization chose to use the donation to make gr ants to physicians, those grants would not constitute ‘indirect payments’ because the appli cable manufacturer did not require, instruct, or direct the organization to use the donation for gr ants to physicians.” Therefore, because such payments are not indirect payments, we do not need to create an additional exclusion specific to continuing education indirect payments by m odifying the indirect payment exclusion at §403.904(i)(1). Comment: Many commenters interprete d the removal of physician speaker compensation at continuing education events wo uld also remove the re porting exclusion for attendees at accredited or certified continuing educa tion events whose fees have been subsidized through the continuing medical education orga nization by an applicab le manufacturers. Response: We did not intend to remove the ex clusion regarding subsid ized fees provided to physician attendees by manufacturers at continuing educati on events. However, we intend forCMS-1612-FC 596

physician speaker compensation and physician atte ndees fees which have been subsidized through the continuing medical e ducation organization by an app licable manufacturer to be reported unless the payment meets the indirect pa yment exclusion at §403.904(i)(1). This allows for consistent reporting for physic ian attendees and speakers at co ntinuing education events. We will provide sub-regulatory guidance specifying tu ition fees provided to physician attendees that have been generally subsidized at continuing ed ucation events by manufact urers are not expected to be reported. However, if a manufacturer does instruct, direct, or otherwise cause the subsidized tuition fee for a continuing education event to go to a specific physician attendee, the payment will not be excluded, since the indir ect payment exclusion only applies if the

manufacturer did not know the ident ity of the physician attendee. Comment: Many commenters interpreted th e proposed removal of§403.904(g) to expand the exclusion to account for continuing education programs accredited or certified for nurses, optometrists, pharmacists, and others. Response: We appreciate the comments, but the removal of§403.904( g) was not intended to expand the exclusion. The intent is to allow for consistent reporting for compensation provided to physician speakers at all continuing education events, as well as transparency regarding compensation paid to physician speakers. Comment: A few commenters requested CMS provide clear and realistic timeframes regarding payments related to continuing educat ion events to allow manufacturers to provide sponsor notice as it considers proposals to eliminate the current CME exclusion. Response: We agree with commenters that manufacturers may need additional time to comply with reporting requirements; therefore, we are finalizing data collection requirements that would begin January 1, 2016 according to this final rule for applicab le manufacturers. 3. Reporting of Marketed Name (§403.904(c)(8))CMS-1612-FC 597

Section 1128G(a)(1)(A)(vii) of the Act requires applicable manufacturers to report the name of the covered drug, device, biological or me dical supply associated with that payment, if the payment is related to ‘‘marketing, educati on, or research’’ of a particular covered drug, device, biological, or medical supply. S ection 403.904(c)(8)(i) requires applicable manufacturers to report the marketed name for each drug or biological related to a payment or

other transfer of value. At §403.904(c)(8)(ii), we require an app licable manufacturer of devices or medical supplies to report one of the followi ng: the marketed name ; product category; or therapeutic area. In the Februa ry 8, 2013, final rule, we provided applicable manufactures with flexibility when it was determined that the mark eted name for all devices and medical supplies may not be useful for the general audience. We did not define product ca tegories or therapeutic areas in §403.904(c). However, since implementa tion of the February 8, 2013 final rule and the development of the Open Payments system, we have determined that aligning the reporting requirements for marketed name across drugs, bi ologics, devices and medical supplies will make the data fields consistent within the system, and also enhance consumer’s use of the data. Accordingly, we proposed to revise §403.904(c) (8) to require applicable manufacturers to report the marketed name for all covered drugs, devices, biologicals or medical supplies. We

believe this would facilitate c onsistent reporting for th e consumers and researchers using the data displayed publicly on the Open Payments. Manuf acturers would still have the option to report product category or therapeutic area, in addition to reporting the market name, for devices and medical supplies.

Comment: We received a few comments re garding revising reporting requirements at §403.904(c)(8). These comments mainly stated that the marketed name for a device or medical supply is not useful for the public because the pu blic is not familiar w ith device or medical supply marketed names. We also received a few comments that supported requiring theCMS-1612-FC 598

reporting of marketed name for devices and me dical supplies. Supporting commenters believe that reporting marketed name for all products w ill allow the public (i ncluding researchers and consumers) to search the data via the Open Pa yments public website for a specific device or medical supply. Commenters also stated that reporting marketed name for non-covered products is not required by the statute and therefore manu facturers should not be required to report marketed names for non-covered products. A dditionally, some comment s indicated reporting marketed name for devices and medical supplies fo r research payments is not practical because there is not a marketed name for every device or medical supply associ ated with research payments; rather there may only be a connectio n to an associated research study. A few

commenters addressed that manufac turers will have an increa sed burden to modify reporting systems to accommodate reporting marketed name for devices and medical supplies. Response: We appreciate the comments supporting our proposed revisions requiring reporting marketed name for devices and medical supplies. We have finalized a modified approach to accommodate concerns regarding re porting related covered drug, device, biological or medical supply information. We agree ma nufacturers should not be required to report marketed names for non-covered products; ther efore, we are finali zing the proposal that reporting marketed names for non-covered drugs, devices, biologicals, or medical supplies will continue to be optional. We al so agree a payment or other transf er of value associated with a research payment regarding a device or medi cal supply may not have a marketed name. Therefore, we are finalizing the proposal that manufacturers will continue to have an option to report either a device or medical supply market ed name, therapeutic area or product category when reporting research payments. After consideration of comments received, we agree that displaying therapeutic areas or product categories are useful for the public reviewing data on th e Open Payments public websiteCMS-1612-FC 599

because the public is not familiar with marketed names for devices and medical supplies. We agree therapeutic areas and pr oducts categories are more rec ognizable by the public. Yet, reporting marketed names for all covered products is necessary to achieve consistent reporting and to have the ability to aggregate all payments or other transfers of value associated with a specific device or medical supply. Therefore to achieve consistent re porting by manufacturers, we will require manufacturers to report marketed name and therapeutic area or product category for all covered drugs, devices, biologicals or medi cal supplies. We also agree with commenters that complying with this reporting requirement will require a change in manufacturers’ reporting systems; therefore, data collection for this reporting requirement w ould begin January 1, 2016. 4. Reporting of Stock, Stock Option, or any other Ownership Interest Section 403.904(d)(3) require s the reporting of stock, st ock option, or any other ownership interest. We proposed to require app licable manufacturers to report such payments as distinct categories. This will enable us to co llect more specific data regarding the forms of payment made by applicable manufacturers. Afte r issuing the February 8, 2013 final rule and the development of the Open Payments system, we determined that this specificity will increase the ease of data aggregation within the system, a nd also enhance consumer’s use of the data. We

solicited comments on the extent to which users of this data set find this disaggregation to be useful, and whether this change presents operati onal or other issues on th e part of applicable

manufacturers. The following is summary of the comments we received regarding the extent to which

users of this data set find this disaggregation to be useful, requ iring reporting of marketed name

for covered devices and medical s upplies, and whether this change presents operational or other issues on the part of a pplicable manufacturers. Comment: Commenters agreed that requiring reporting of stock, stock option or anyCMS-1612-FC 600

other ownership interest in di stinct categories is useful. Response: We agree the disaggregation of repor ting stock, stock option or any other ownership

interest in distinct ca tegories. Therefore, we have fina lized this provision as proposed, which requires reporting stock, stock opt ion, or any other ownership intere st form of payment or other transfer of value in distinct categories.CMS-1612-FC 601

J. Physician Compare Website 1. Background and Statutory Authority Section 10331(a)(1) of the Affordable Ca re Act, requires that, 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 (E Ps) who participate in the Physician Quality Reporting System (PQRS) under section 1848 of the Act. CMS launched the first phase of Physician Compare on December 30, 2010 ( http://www.medicare. gov/physiciancompare ). In the initial phase, we posted the names of EPs that satisfactorily submitted quality data for the 2009 PQRS, as required by section 1848(m)(5)(G) of the Act. Section 10331(a)(2) of the Affordable Care Act also requires that, no later than January 1, 2013, and for reporting periods that began no earlier than January 1, 2012, we implement a plan for making publicly availa ble through Physician Compare information on physician performance that provides comparable information on quality and patient experience measures. We met this requirement in advance of January 1, 2013, as outlined below, and plan to continue addressing elements of the plan through rulemaking. To the extent that scientifically sound meas ures are developed and are available, we are required to include, to the ex tent practicable, the following types of measures for public reporting:

● Measures collected under the Phys ician Quality Reporting System (PQRS).

● An assessment of patient health outc omes and functional status of patients.

● An assessment of the c ontinuity and coordination of care and care transitions, including episodes of care and risk-adjusted resource use.CMS-1612-FC 602

● 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 determin ed 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 posting to P hysician Compare. We have established a 30-day preview period for all measurement performance data that will a llow physicians and other EPs to view their data as it will appear on the website in advance of publication on Physician Compare (77 FR 69166 and 78 FR 74450). Details of the preview process will be communicated dire ctly to those with measures to preview and will also be publishe d on the Physician Compare Initiative page ( http://www.cms.gov/Medicare/Qua lity-Initiatives-Patient-Assessm ent-Instruments/physiciancompare-initiative/ ) in advance of the preview period.

● 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 the Medicare program and, to the extent applicable, other payers, to the extent such information would provide a more accurate portr ayal 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.CMS-1612-FC 603

● 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 reporting activities. Section 10331(d) of the Affordable Care Act requires us to consider input from multi-stakeholder groups, consistent with se ctions 1890(b)(7) and 1890A of the Act, when selecting quality measures for Physician Compare. We also continue to get general input from stakeholders on Physician Compare through a va riety of means, including rulemaking and different forms of stakeholder outreach (for ex ample, Town Hall meetings, Open Door Forums, webinars, education and outreach, Technical Expert Panels, etc.). In developing the plan for making information on physician performance public ly available through Physician Compare, section 10331(e) of the Affordable Care Act requires the Secretar y, as the Secretary determines appropriate, to consider the plan to transition to value-based pu rchasing for physicians and other practitioners that was developed und er section 131(d) of the MIPPA. Under section 10331(f) of the Affordable Care Act, we are required 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 that will help them make informed decisions about their health care, while encouraging clinicians to improve the quality of care theyCMS-1612-FC 604

provide to their patients. In accordance with se ction 10331 of the Affordable Care Act, we plan to publicly report physician performance information on Physician Compare. 2. Public Reporting of Performance and Other Data Since the initial launch of the website, we have continued to build on and improve Physician Compare. On June 27, 2013, we launched a full redesign of Physician Compare bringing significant improvement s including a complete overhaul of the underlying database and a new Intelligent Search feature, addressing two of our stakeholders ’ primary critiques of the site – the accuracy and currency of the database a nd the limitations of the search function – and considerably improving website functionality and usability. Provider Enrollment, Chain, and Ownership System (PECOS), as the sole source of verified Medicare prof essional information, is the primary source of administ rative information on Physician Compare. With the redesign, however, we incorporated the use of Medicare Fe e-For-Service claims information to verify the information in PECOS to help ensure only the mo st current and accurate information is included on the site. For example, claims information is used to determine which of the active and approved practice locations in PECOS are where th e professional is curren tly providing services. Claims information helps confirm that only th e most current group practice affiliations are

included on the site. Our use of claims also helps ensure that we are posting on Physician Compare the most current and accurate inform ation available about the professionals for

Medicare consumers.

We received several comments about the e nhancements made to the Physician Compare website and the data currently on the website.

Comment: Several commenters noted the im provements made to the Physician Compare website, including the additional labeling, improveme nts to the “Is this you?” link, the reordering of the search results, the Intelligent Search f unctionality, the use of claims data to verifyCMS-1612-FC 605

professionals’ demographic information, denoting board certified physicians with contextual text, and explanations and disc laimers about each of the federal quality reporting programs

included on the website. Commente rs also noted an appreciation for the transparency and easyto-use, comprehensive information available on th e site to aid consumers in making informed

health care decisions. Some commenters provided sugge stions for future Physician Compare enhancements. A few commenters suggested continued improvements to the Intelligent Search functionality to better find health care professiona ls other than physicians and additional specialty labels for Advanced Practice Registered Nurses (APR Ns) and allied health professionals. Response: We appreciate the commenters’ feedback and the con tinued support for the Physician Compare website. We are committed to continuing to improve the site and its functionality to ensure it is a useful resource for Medicare cons umers, including information that can help these consumers make informed health care decisions. We also appreciate the recommendations regarding other health care professionals, and we will evaluate these recommendations for potential future inclusion. Also, we are continua lly working to improve and enhance the Intelligent Search functionality.

Comment: Some commenters e xpressed concerns about the accuracy of data such as demographic information, specialty classification, and hospital affiliation. Several commenters urged CMS to address these concerns prior to posting additional quality measure performance

information on the website. Other commenters requested we implement a streamlined process by which professionals can confirm or correct their information in a timely manner. One commenter urged CMS to ensure that updates made in PECOS are reflected on Physician Compare within 30 days, while another commen ter cautioned against using PECOS for updating information. Several commenters suggested continui ng to work with stakeholders, particularlyCMS-1612-FC 606

health care professionals, and/or providing educational material regarding how to keep data

current to ensure the acc uracy of the website. Response: We appreciate the commenters ’ feedback regardi ng concerns over the accuracy of the information currently available on Physician Compare. We are committed to including accurate and up-to-date information on Physician Compare and continue to work to make improvements to the information presented. The underlying database on Physician Compare is generated from PECOS, as well as Fee-For-Service (FFS) claims, and it is therefor e critical that physicia ns, other health care professionals, and group practices ensure that their information is up-to-date and as complete as possible in the national PECOS database. Cu rrently, the most immediate way to address inaccurate PECOS data on Physician Compare is by updating information via Internet-based

PECOS at https://pecos.cms.hhs.gov/pecos/login.do . Please note that the specialties as reported on Physician Compare are those specialties repo rted to Medicare when a physician or other health care professional enrolls in Medicare and are limited to the specialties noted on the 855i Enrollment Form. All addresses listed on Physician Compare must be entered in and verified in

PECOS. There is a lag between when an edit is made in PECOS and when that edit is processed by the Medicare Administrative Contractor (MAC) and available in the PECOS data pulled for Physician Compare. This time is necessary for data verification but unfor tunately results in a delay updating information. We are continually working to find wa ys to minimize this delay. To update information not found in PECOS, such as hospital affiliation and foreign language, professionals and group practices should contact the Physician Compare support team directly at PhysicianCompare@Westat.com. Information regarding how to keep your

information current can also be found on th e Physician Compare Initiative page on CMS.govCMS-1612-FC 607

(http://www.cms.gov/Medicare/Qua lity-Initiatives-Patient-Assessm ent-Instruments/physiciancompare-initiative/)

. Although we appreciate the concerns ra ised around the PECOS data included on Physician Compare, it is necessary to continue the use of the PECOS data as it is the sole,

verified source of Medicare information. Howeve r, we are aware of its limitations. For these reasons, we have instituted the use of claims information and are continuing to work to find ways to further improve the data. The data are significantly better today than they were prior to the 2013 redesign and continues to improve. We st rongly encourage all professionals and group practices listed on the site to regularly check thei r data and to contact th e support team with any questions or concerns. Currently, website users can view informa tion about approved Medi care professionals such as name, primary and secondary specialties , practice locations, group affiliations, hospital affiliations that link to the hospital’s profile on Hospital Compare as available, Medicare Assignment status, education, languages spoken, a nd American Board of Medical Specialties (ABMS) board certification information. In ad dition, for group practices , users can also view group practice names, specialties, practice locations, Medicare a ssignment status, and affiliated professionals. We post on the website the names of indivi dual EPs who satisfactorily report under PQRS, as well as those EPs who are successful electronic prescribers under the Medicare Electronic Prescribing (eRx) Incentive Program . Physician Compare contains a link to a

downloadable database of all in formation on Physician Compare ( https://data.medicare.gov/ data/physician-compare ), including information on this quality program participation. In addition, there is a section on each Medicare professional’s profile page indicating with a green check mark the qu ality programs under which the EP satisfactorilyCMS-1612-FC 608

or successfully reported. We proposed (79 FR 40386) to continue to include this information annually in the year following the year it is re ported (for example, 2015 PQRS reporting will be included on the website in 2016). We did not receive any comme nts on this proposal. We are finalizing this proposal at this time, and theref ore, will include satisfactory 2015 PQRS reporters on the website in 2016. The eRx Incentive Progra m ends in 2014 so those data will not be available in 2015 or beyond. With the Physician Compare redesign, we added a quality programs section to each group practice profile page in order to indicate which group practices ar e satisfactorily reporting in the Group Practice Reporting Option (GPRO) under PQRS or are successful electronic prescribers under the eRx Incentive Program. We have al so included a notation and check mark for individuals that successfully pa rticipate in the Medicare EHR Incentive Program, as authorized by section 1848(o)(3)(D) of the Ac t. We proposed (79 FR 40386) to continue to include this information annually in the year following the year it is reported (for example, 2015 data will be included on the website in 2016). We did not receive any commen ts regarding our proposal regarding this PQRS GPRO. We are finalizing the proposal to include a notation for satisfa ctory PQRS GPRO reporters. As noted above, the eRx Incentive Program is ending in 2014, and therefore, th ere will not be data for this program in 2015 or beyond. We did receive comments regarding including a notation for

individuals that successfu lly participate in the Medi care EHR Incentive Program. Comment: Two commenters urged CMS to reco nsider its decision to publicly report participation in the Medicare EHR Incentive Program due to ongoing issues related to the program--including unresolved challenges related to vendor certification de lays, concerns about the relevancy to consumers, and limited abilit y to implement core measures. One commenter suggested including a disclaimer next to the i ndicator explaining these barriers and clarifyingCMS-1612-FC 609

that successful participation in the EHR Incen tive Program is only one of various ways to

demonstrate an investment in higher quality care. Response: We appreciate the commenters’ f eedback, and we will take the suggestions provided regarding a disclaimer into consideratio n for possible future enhancements. We also appreciate the concerns raised about the program, specifically around vendor certification and core measures. However, despite those poten tial limitations, a number of professionals and groups are successfully taking part at this time and we believe it is important to continue to recognize them. Also, consumers find this informa tion interesting and helpful. This is only one of multiple quality programs included on Physician Compare that we find important to highlight. As a result, we are going to finalize our proposal to continue including an indicator for participation in the EHR Incentive Program on the website. We previously finalized a d ecision to publicly report the names of those EPs who report the 2014 PQRS Cardiovascular Prevention meas ures group in support of Million Hearts on Physician Compare in 2015, by including a check ma rk in the quality programs section of the profile page (78 FR 74450). We proposed (79 FR 40386) to also continue to include this information annually in the year following the year it is reported (for example, 2015 data will be included on Physician Compare in 2016).

Comment: Some comment ers supported our proposal to publicly report and include an indicator for EPs who report th e 2015 PQRS Cardiovascular Prevention measures group in support of Million Hearts. Commenters noted that Million Hearts is an important initiative for supporting cardiovascular health. Response: We appreciate the commenters’ supp ort. We agree that Million Hearts is an important initiative that is improving outcomes for cardiovascular healt h. However, we are finalizing the removal of the Cardiovascular Prevention measure group from the PQRS programCMS-1612-FC 610

given that the two cholestero l control measures included in the measure group are no longer clinically relevant, and therefore, the measur e group no longer meets the necessary threshold for PQRS of six measures and will no longer be avai lable for reporting under the program. With the

removal of the 2 cholesterol control measures , the remaining measures from the original

Cardiovascular Preventi on measure group are:

● Ischemic Vascular Disease (IVD): Us e of Aspirin or Another Antithrombotic.

● Preventive Care and Screening: Tobacco Use.

● Controlling High Blood Pressure.

● Preventive Care and Screening: Scr eening for High Blood Pressure and Follow-Up

Documented.

All of these measures are avai lable as individual measures under PQRS. Given that the

Cardiovascular Prevention meas ure group is being eliminated from the PQRS, but that the remaining measures identified above will be avai lable for individual reporting, we are modifying our final policy with regard to our proposal to support Million Hearts on Physician Compare. Specifically, we are finalizing that any EP that satisfactorily reports all four of the individual measures noted above will receive a green check mark indicating support for Million Hearts. A key strategy of the Million Hearts initiative is to reduce the number of heart attacks and strokes, and the program has found that reporting these quality measures is a first step toward performance improvement. We are committed to supporting this initiative, and even though the measure group is no longer available under PQRS , we think it is important to continue recognizing those individual EPs who are repor ting these quality measures as individual measures. Even though the individual measures require that a potenti ally higher number of patients are reported on – 50 percent of patients that meet the sample requirements versus just 20 patients for the measure group – we believe this does not increase burden on reporters because asCMS-1612-FC 611

currently available claims data show, signifi cantly more EPs are already reporting these measures as individual PQRS measures versus as part of the Cardiovascular Prevention measures group. Ensuring these professionals are recognized for reporting these measures is important in ensuring we are continuing support for this im portant program despite the measure group no longer being available for reporting. Finally, we will also indicate with a green ch eck mark those individuals who have earned the 2014 PQRS Maintenance of Certification Ince ntive (Additional Incenti ve) on the website in 2015 (78 FR 74450). Comment: Several commenters supported pub licly reporting earne rs of the PQRS Maintenance of Certification (MOC) program A dditional Incentive, as well as ABMS Board Certification data, while other commenters are co ncerned that ABMS data are not complete or only include some specialists. Multiple co mmenters suggested including other Boards’ certifications and MOC programs, contextual certif ication process information, and the certifying

Board’s identification. Response: We appreciate the commenters' feedback and support for including ABMS and PQRS MOC information on Physician Compare. We also understand the concerns that not all specialties are presented by the ABMS data and will review the recommendations made to

include additional certificati on and MOC program information on the website for possible

inclusion in the future. We continue to implement our plan fo r a phased approach to public reporting performance information on Physician Compare. Th e first phase of this plan was finalized with the CY 2012 PFS final rule with comment period (76 FR 73419-73420), where we established that PQRS GPRO measures collected through the GPRO We b Interface for 2012 would be publicly reported on Physician Compare. The plan was expanded with the CY 2013 PFS finalCMS-1612-FC 612

rule with comment period (77 FR 69166), where we established that the specific GPRO Web Interface measures that would be posted on P hysician Compare would include the PQRS GPRO measures for Diabetes Mellitus (D M) and Coronary Artery Diseas e (CAD), and we noted that we would report composite measures for these m easure groups in 2014, if technically feasible. 6 The 2012 PQRS GPRO measures were publicly reported on Physician Compare in February 2014. Data reported in 2013 on the GPRO DM and GPRO CAD measures and co mposites collected via

the GPRO Web Interface that meet the minimum sample size of 20 patients and prove to be statistically valid and reliable will be publicly reported on Physician Compare in December CY 2014, if technically feasible. If th e minimum threshold is not met fo r a particular measure, or the

measure is otherwise deemed not to be suitab le for public reporting, the group’s performance rate on that measure will not be publicly repor ted. We will only publish on Physician Compare those measures that are statistically valid and reliable, and therefore, most likely to help

consumers make informed decisions about the Medi care professionals they choose to meet their

health care needs.

Measures must be based on reli able and valid data elements to be useful to consumers and thus included on Physician Compare. A reliabl e data element is consistently measuring the same thing regardless of when or where it is co llected, while a valid data element is measuring

what it is meant to measure. To address the re liability of performance scores, we will measure the extent to which differences in each quality m easure are due to actual differences in clinician performance versus variation that arises from measurement erro r. Statistically, reliability depends on performance variation for a measur e across clinicians (“ signal”), the random variation in performance for a m easure within a clinician’s pane l of attributed beneficiaries

6 By “technically feasible” we mean that there are no operational constraints inhibiting us from moving forward on a given public reporting objective. Operational constraints include delays and/or issues related to data collection which render a set of quality data unavailable in the timeframe necessary for public reporting.CMS-1612-FC 613

(“noise”), and the number of beneficiaries attribut ed to the clinician. High reliability for a measure suggests that comparisons of relative performance across clinicians are likely to be stable over different performance periods and that the performance of one clinician on the quality measure can confidently be distinguished from anot her. Potential reliability values range from zero to one, where one (highest possible reliability) means that all variation in the measure’s

rates is the result of variation in differences in performance, while zero (lowest possible reliability) means that all variati on is a result of measurement error. Reliability testing methods

included in the CMS Measures Management System Blueprint ( https://www.cms.gov/Medicare/Quali ty-Initiatives-Patient-AssessmentInstruments/MMS/MeasuresMana gementSystemBlueprint.html ) include test-retest reliability and analysis of variance (ANOVA). Reliability test s endorsed by the NQF include the beta-binomial

model test. The validity of a measure refers to the ability to record or quantif y what it claims to measure. To analyze validity, we can investigat e the extent to which each quality measure is correlated with related, previously validated, m easures. We can assess both concurrent and predictive validity. Predictive validity is most appropriate for process measures or intermediate outcome measures, in which a cause-and-effect relationship is hypothesized between the measure in question and a validated outcome measure. Th erefore, the measure in question is computed first, and the validated measure is computed using data from a later period. To examine concurrent validity, the measure in question and a previously validated measure are computed using contemporaneous data. In this context, th e previously validated m easure should measure a

health outcome related to the outcome of interest. Comment: Many commenters supported only publishing on Physician Compare those measures that are statistically valid and reliable. Several comm enters urged CMS to carefullyCMS-1612-FC 614

assess if all GPRO measure data is sufficiently reliable and va lid for public reporting before posting the data. One commenter recommended re moving any measures deemed unreliable or inaccurate. One commenter recommended a one-y ear delay in public reporting of all new measures to enable professionals to accurately report the measures and to account for measure testing and validity. One commenter requested CMS publish the result s of validity and reliability studies, as well as the methodology for choosing measures prio r to posting on Physician Compare. Another

commenter is concerned that meas ures related to patient behavior , preferences, or abilities do not provide a statistically valid portr ayal of a health care professi onal’s performance and should not be published unless the data is appropriately risk adjusted. Several other commenters also strongly urged CMS to move forward with expanding its risk adjustment methodology. Response: We appreciate the commenters’ feed back, and understand the concerns raised. As required under section 10331(b) of the Affordable Care Act, in developing and implementing the plan to include performance data on Physic ian Compare, we must include, to the extent practicable, processes to ensure th at the data posted on the website are statistically valid, reliable, and accurate, including risk adjustment mechanis ms used by the Secretary. We understand that this information is complex and are committed to providing data on Physician Compare that are

useful to beneficiaries in assi sting them in making informed h ealth care decisions, while being accurate, valid, reliable, and complete. We w ill closely evaluate all quality measures under consideration for public reporting on the website to ensure they are meeting these standards. We will also only post data that meet the established standards of reliability and validity regardless of threshold, and regardless of measure type. Should we fi nd a measure meeting the minimum threshold to be invalid or unreliable for any re ason, the measure will not be reported. We are also making changes in light of the concerns about first year measures. We will not publicly postCMS-1612-FC 615

measures that are in their first year given the concerns raised about th eir validity, reliability, accuracy, and comparability. After a measure’s firs t year in the program, CMS will evaluate the

measure to see if and when the measure is suit able for pubic reporting. Also, we will continue to analyze the measure data to ensure that risk ad justment concerns are taken into consideration. All data are analyzed and revi ewed by our Technical Expert Pa nel (TEP). A summary of the TEP recommendations is made public on the Physician Compare Initiative page ( http://www.cms.gov/Medicare/Qua lity-Initiatives-Patient-Assessm ent-Instruments/physiciancompare-initiative/Informational-Materials.html ) when available.

In the November 2011 Medicare Shared Savi ngs Program final rule (76 FR 67948), we noted that because Accountable Care Organiza tion (ACO) providers/supplie rs that are EPs are considered to be a group practice for purposes of qualifying for a PQ RS incentive under the Shared Savings Program, we would publicly re port ACO performance on quality measures on Physician Compare in the same way as we re port performance on quality measures for PQRS GPRO group practices. Public reporting of performance on these measures is presented at the ACO level only. The first sub-set of ACO meas ures was also published on the website in February 2014. ACO measures can be viewed by following the link for Accountable Care Organization (ACO) Quality Data on the hom epage of the Physician Compare website ( http://medicare.gov/physi ciancompare/aco/search.html ). As part of our public reporting plan for Physician Compare, in the CY 2013 PFS final rule with comment period (77 FR 69166 and 69167), we also finalized th e decision to publicly report Clinician and Group Consumer Assessmen t of Healthcare Providers and Systems (CGCAHPS) data for group practices of 100 or more eligible professionals reporting data in 2013 under the GPRO and for ACOs participating in the Shared Savings Program, if technically feasible. We anticipate posti ng these data on Physician Compar e in late 2014, if available.CMS-1612-FC 616

We continued to expand our plan for public reporting data on Physician Compare in the CY 2014 PFS final rule with comment period (78 FR 74449). In that final rule we finalized a decision that all measures collected through the GPRO Web Interface for groups of two or more EPs participating in 2014 under th e PQRS GPRO and for ACOs pa rticipating in the Medicare Shared Savings Program would be available fo r public reporting in CY 2015. As with all measures we finalized with regard to Physic ian Compare, these data would include measure performance rates for measures reported that m eet the minimum sample size of 20 patients and prove to be statistically valid and reliable. We also finalized a 30-day preview period prior to publication of quality data on Physic ian Compare. This will allo w group practices to view their data as it will appear on Physician Compare before it is publicly reported . We decided that we will detail the process for the 30-day preview and provide a detailed timeline and instructions for preview in advance of the start of the preview pe riod. ACOs will be able to view their quality data that will be publicly reported on Phys ician Compare through the ACO Quality Reports,

which will be made available to ACOs for review at least 30 days prior to the start of public reporting on Physician Compare. We also finalized a decision to publicly report in CY 2015 on Physician Compare performance on certain measures that group practic es report via registries and EHRs in 2014 for the PQRS GPRO (78 FR 74451). Specifically, we finalized making available for public reporting performance on 16 registry measures and 13 EHR measures (78 FR 74451). These

measures are consistent with the measures availa ble for public reporting vi a the Web Interface. We will indicate the mechanism by which these data were collected and only those data deemed statistically comparable, valid, and re liable would be published on the site. We also finalized publicly re porting patient experience survey-based measures from the CG-CAHPS measures for groups of 100 or more e ligible professionals who participate in PQRSCMS-1612-FC 617

GPRO, regardless of GPRO submission met hod, and for Shared Savings Program ACOs reporting through the GPRO Web Interface or ot her CMS-approved tool or interface (78 FR 74452). For 2014 data, we finalized publicly repor ting data for the 12 summary survey measures also finalized for groups of 25 to 99 for PQRS reporting requirements (78 FR 74452). These summary survey measures would be available for public reporting group practices of 100 or more EPs participating in PQRS GPRO, as well as group practices of 25 to 99 EPs when collected via any certified CAHPS vendor regard less of PQRS participation, as technically feasible. For ACOs participating in the Sh ared Savings Program, the patient experience

measures that are included in the Patient/ Caregiver Experience domain of the Quality Performance Standard under the Shared Savings Program (78 FR 74452) will be available for public reporting in 2015. For 2014, we also finalized publicly repor ting 2014 PQRS measure data reported by individual EPs in late CY 2015 for individual PQ RS quality measures speci fically identified in the final rule with comment period, if technically feasible. Specifically, we finalized to make available for public reporting 20 individual meas ures collected through a registry, EHR, or claims (78 FR 74453-74454). These are measures th at are in line with those measures reported by groups via the GPRO Web Interface. Finally, in support of the HHS-w ide Million Hearts Initiative , we finalized a decision to publicly report, no earlier than CY 2015, perf ormance rates on measures in the PQRS

Cardiovascular Prevention measur es group at the indivi dual EP level for data collected in 2014 for the PQRS (78 FR 74454). See Table 48 for a summary of our final policies for public reporting data on Physician Compare.CMS-1612-FC 618

TABLE 48: Summary of Previously Finalized Policies for Public Reporting on Physician Compare Data Collection Year Public Reporting Year Reporting Mechanism(s) Quality Measures and Data for Public Reporting

2012 2013 Web Interface (WI), EHR, Registry, Claims Include an indicator for satisfactory reporters under PQRS successful e-prescribers under eR x, and participants in the EHR Incentive Program. 2012 2014 WI 5 Diabetes Mellitus (DM) and Coronary Artery Disease (CAD) measures collected via the WI for group practices reporting under PQRS GPRO with a minimum sample size of 25 patients and Shared Savings Program ACOs. 2013 2014 WI, EHR, Registry, Claims Include an indicator for satisfactory reporters under PQRS, successful e-prescribers under eR x, and participants in the EHR Incentive Program. Include an indicator for EPs who earn a PQRS Maintenance of Ce rtification Incentive and EPs who report the PQRS Cardiovascular Prevention measures group in support of Million Hearts. 2013 Expected to be December 2014 WI Up to 6 DM and 2 CAD meas ures collected via the GPRO WI for groups of 25 or more EPs and Shared Savings Program ACOs with a minimum sample size of 20 patients. Will include composites for DM and CAD, if feasible. 2013 Expected to be December 2014 WI Up to 5 CG-CAHPS summary measures for groups of 100 or more EPs reporting under PQRS GPRO via the WI and up to 6 ACO CAHPS summary measures for Shared Savings Program ACOs. 2014 Expected to be 2015 WI, EHR, Registry, Claims Include an indicator for satisfactory reporters under PQRS and participants in the EHR In centive Program. Include an indicator for EPs who earn a PQRS Maintenance of Certification Incentive and EPs who report the PQRS Cardiovascular Prevention measures group in support of Million Hearts. 2014 Expected to be late 2015 WI, EHR, Registry, Administrative Claims All measures reported via th e GPRO WI, 13 EHR, and 16 Registry GPRO measures are also available for group practices of 2 or more EPs reporting under PQRS GPRO with a minimum sample size of 20 patients. Also, all Shared Savings Program ACO measures are available for public reporting. Include composites for DM and CAD, if feasible. 2014 Expected to be late 2015 WI, Certified Survey Vendor Up to 12 CG-CAHPS summary measures for groups of 100 or more EPs reporting via the WI and group practices of 25 to 99 EPs reporting via a CMS-approved certified survey vendor, as well as 6 ACO CAHPS summary measures for Shared Savings Program ACOs reporting through the GPRO Web Interface or other CMS-approved tool or interface. 2014 Expected to be late 2015 Registry, EHR, or Claims A sub-set of 20 PQRS measures submitted by individual EPs that align with those availabl e for group reporting via the WI and that are collected through a Registry, EHR, or claims with a minimum sample size of 20 patients. 2014 Expected to be late 2015 Registry Measures from the Cardiova scular Prevention measures group reported by individual EPs in support of the Million Hearts Initiative with a minimum sample size of 20 patients.CMS-1612-FC 619

3. Final Policies for Public Data Disclosure on Physician Compare in 2015 and 2016 We are continuing the expansion of public reporting on Physician Compare by making an even broader set of quality measures available for publication on the website. We started the phased approach with a small number of possibl e PQRS GPRO Web Interface measures for 2012 and have been steadily building on this to provide Medicare consum ers with more information to help them make informed health care decisions . As a result, we pr oposed (79 FR 40388) to increase the measures available for public reporting in the CY 2015 proposed PFS rule. Comment: Although multiple commenters supported continuing the phased approach to public reporting of quality data, a number of commenters are c oncerned with the aggressive timeline for publicly reporting performance data . Several commenters supported a more gradual approach to public reporting to evaluate the public response to data prior to widespread implementation, ensure accuracy, and present data in a format that is easy to understand, meaningful, and actionable for bot h patients and health care prof essionals. A few commenters

were unsure if CMS conducted anal ysis of consumer use of the site and urged CMS to do so. Other commenters opposed the extensive expa nsion until existing website problems are

addressed. Response: We appreciate the commenters’ feedback, and we appreciate the concerns raised. However, we believe that public reporting of quality data has been a measured, phased approach which started with th e publication of just five 2012 PQRS GPRO measures collected via the Web Interface for 66 group practices and 141 ACOs (76 FR 73417) and continues with a similarly limited set of 2013 PQRS GPRO Web In terface measures (77 FR 69166). We started to build on this plan with the 2014 Physician Fe e Schedule (PFS) final rule (78 FR 74446). This rule made additional PQRS GPRO measures availa ble for public reporting, including a subset of measures reported via Registry and EHR, as well as a sub-set of 20 individual EP PQRSCMS-1612-FC 620

measures. Therefore, the proposals put forth this year are just the next step in the process to realize goals for authorization of Physician Comp are. We are confident that taking this phased approach has afforded us the opportunity to prepare for this si gnificant expansion. Throughout this process, we have been enga ging with consumers and stakeholders and regularly testing the site and the information to be included to ensure it is accurately presented and understood. We are also continually working to improve the website and the administrative and demographic information included. We conti nue to encourage physician s, other health care professionals, and group practices to ensure their information is updated in PECOS so that we

can ensure the most accurate information is avai lable on Physician Compare. We also encourage individuals and groups to reach out to the Physician Compare support team at PhysicianCompare@Westat.com for any questions or concerns regarding the information

included on the website. We proposed (79 FR 40388) to expand public reporting of group- level measures by making all 2015 PQRS GPRO meas ure sets across group reporting mechanisms – GPRO Web Interface, registry, and EHR – available for public reporting on Physician Compare in CY 2016 for groups of 2 or more EPs, as appropriate by reporting mechanism. 7 Similarly, we also proposed that all measures reported by Shared Savings Program ACOs would be available for public reporting on Physician Compare. As with all quality measures proposed for inclusion on Physician Compare, we noted that only measures that prove to be valid, reliable, and accurate upon analysis and review at the conclusion of data collection would be in cluded on the website. Comment: Commenters were both positive a nd negative in regard to our proposal to expand the group-level measures available for p ublic reporting to all measures reported under

7 Tables Q1-Q27 detail proposed changes to available PQRS measures. Additional information on PQRS measures can be found on the CMS.gov PQRS website at http://www.cms.gov/Medicare/Quality-Initiatives-PatientAssessment-Instrume nts/PQRS/index.html

.CMS-1612-FC 621

2015 PQRS GPRO. Commenters in support of the proposal noted group-level measures are a robust indication of care team quality and helpfu l to consumers. Some commenters opposed the expansion and cited concerns with the accuracy of current data as well as measure fidelity. One commenter encouraged CMS to ensure that GPRO quality data is accurately labeled and accessible through the group entry only to ensure it is clear what the quality measure represents.

One commenter asked for clarification on the av ailability of the PQ RS GPRO Web Interface reporting option for groups of two or more EPs. Response: We appreciate the commenters’ feedback on our proposal to report all 2015 PQRS measures reported via the Web Interface, EHR, and Regist ry for group practices of 2 or more EPs participating in the PQRS GPRO. As noted, Physician Compare will only publicly report those measures evaluated to be comparable, reliable, and valid. Also, we will continue to work to ensure that measures are labeled accurately and accompanied by explanations that are both true to the measure specifications and accu rately understood by health care consumers, while adhering to HHS plain language guidelines. Measure data accuracy is of paramount importance to CMS. The measure data currently available on Physician Compare was previewed by those group practices that currently have 2012 PQRS GPRO data available on Physician Compare prior to publication with no concerns raised regarding accuracy. Since being published, no group practices with GPRO data have raised concerns regarding the accuracy of the measure data available. To confirm, the Web Interface reporting option will remain limited to groups of 25 or more EPs. Smaller groups, gr oups of 2 to 24 EPs, can report under the PQRS via EHR or Registry. We also clarify that group -level data is only published at the group level – included on the group practice profile page -- on Physician Compare. And, in response to comments that raised concern about measures reporte d in the first year, we have decided that weCMS-1612-FC 622

will not publicly report a measure that is in its firs t year. By first year we mean a measure that is newly available for re porting under PQRS. We also received comments specifically about EHR measures. Comment: Commenters were opposed to public ly reporting EHR measur es, citing that it is too soon to publicly post performance data fr om eCQMs without additional work to verify the validity and accuracy of the measure results. One commenter sugge sted that new quality measures could be piloted by health care profe ssionals prior to requiring their use within a federal program. One commenter strongly encour aged developing a tutori al that allows the public to better understand this data. Response: We appreciate the commenters' feedback regarding including measures collected via EHRs. Group practices will have th e ability to report measures via an EHR prior the 2015 data collection. Therefore, this reporting m echanism will not be in its first year of use at this time. As a result, we do not believe it is t oo soon to report these quality measures. As noted, only comparable, valid, reliable, and accurate data will be included on Physician Compare. All measures slated for public reporting will be cons umer tested to ensure they are accurately understood prior to publication. If concerns surface from this te sting, we will evaluate if the requirements for public reporting are not suitably me t and if the measure or measures in question should be suppressed and not publicly reported to ensure only those measures that are valid, reliable, and accurate and inform qu ality choice are included on the site. Given the value of these group-level data, and the successful publication of such data to date, we are finalizing our propos al to report all 2015 PQRS measures for al l reporting options for group practices of 2 or more EPs partic ipating in PQRS GPRO , and all 2015 measures reported by ACOs. Consistent with this final po licy, we are making a conforming change to theCMS-1612-FC 623

regulation at §425.308(e) to provide that all quali ty measures reported by ACOs will be reported on Physician Compare in the same way as fo r group practices that report under the PQRS. We also proposed (79 FR 40389) that measures must meet the public reporting criteria of a minimum sample size of 20 patients. Comment: Several commenters supported the proposed minimum sample size of 20 patients. However, the majority of commenters believed a patient threshold of 20 is too low to be statistically valid, which commenters claim may result in inaccurate quality scores based on

one outlier. Commenters recomm ended CMS use a higher threshold to ensure validity. Several commenters also urged CMS to te st measures and composites with 20 patients and to provide an opportunity for public comment and to review reliability and validity. Response: We appreciate the commenters’ feedback and unde rstand the concerns raised regarding the 20 patient minimum sample size. However, we believe this threshold of 20 patients is a large enough sample to protect pa tient privacy for reporting on the website, and aligns with the reliability threshold previously finalized for the Valu e-Based Modifier (VM) (77 FR 69166). As we continue to work to align quality initiatives and minimize reporting burden on physicians and other health care professi onals, we are finalizing a patient sample size of 20 patients. We proposed to include an indicator of whic h reporting mechanism was used and to only include on the site measures deemed statistically comparable. 8 We received several comments regarding data comparability, generally.

Comment: Some commenters e xpressed concern with the co mparability of measures reported through different reporting mechanisms and requested notation specifying the measure differences. One commenter supported only public ly reporting measures with specifications

8 By statistically comparable, CMS means that the quality measures are analyzed and proven to measure the same phenomena in the same way regardless of the mechanism through which they were collected.CMS-1612-FC 624

consistent across all reporting mechanisms, wh ile another commenter recommended that CMS group results by the data collection methodology to improve comparability. Response: Though we understand concerns rega rding including measures collected via different mechanisms, CMS is conducting analyses to ensure that thes e measures align across different reporting mechanisms. This analysis is done on a measure per measure basis. For example, if a measure is reported via claims, th en the measure specifications would be aligned with a measure being reported via EHR as long as it stays consistent with the original measure intent. Only those measures that are prove n to be comparable and most suitable for public reporting will be included on Physicia n Compare and made publicly available. Therefore, we are finalizing our proposal to report data from the av ailable reporting mechanisms and to include a notation indicating which re porting mechanism was used. We proposed (79 FR 40389) to publicly report all measures submitted and reviewed and found to be statistically valid and reliable in the Physician Compare downloadable file. However, we proposed that not all of these measures necessarily would be included on the Physician Compare profile pages. As we noted, consumer testing has shown profile pages with too much information and/or measures that are not well understood by consumers can negatively impact a consumer’s ability to make informed d ecisions. Our analysis of the collected measure data, along with consumer testing and stakehol der feedback, will determine specifically which measures are published on profile pages on the website. Statistical analyses will ensure the measures included are statistically valid and re liable and comparable across data collection

mechanisms. Stakeholder feedback will ensure a ll measures meet current clinical standards.

CMS will continue to reach out to stakeholders in the professional community, such as specialty societies, to ensure that the measures under c onsideration for public repor ting remain clinically

relevant and accurate. When measures are finali zed significantly in advance of moment they areCMS-1612-FC 625

collected, it is possible that clinical guidelines can change rendering a measure no longer relevant. Publishing that measur e can lead to consumer confusi on regarding what best practices their health care professional should be subscribing to. As we noted in the proposed rule (79 FR 40389), the primary goal of Physician Compare is to help consumers make info rmed health care decisions. If a consumer does not properly interpret a quality measure and thus misunders tands what the quality score represents, the

consumer cannot use this information to make an informed decision. Through concept testing, CMS will test with consumers how well they understand each measure under consideration for public reporting. If a measure is not consistently understood and/or if consumers do not

understand the relevance of the measure to thei r health care decision making process, CMS will not include the measure on the Physician Compare profile page as inclusion will not aid informed decision making. Finally, consumer testing will help ensure the measures included on the profile pages are accurately understood and relevant to consum ers, thus helping them make

informed decisions. This will be done to en sure that the information included on Physician Compare is consumer friendl y and consumer focused. Comment: Several commenters supported the proposal to have all 2015 measures available for download with only a select group of measures on the website. One commenter further emphasized CMS should create consistent formatting with Hospital Compare

downloadable files. Response: We appreciate the commenters’ feedback and su pport for this proposal. We are finalizing the proposal to include all m easures in a downloadable file and limiting the measures available on Physician Compare profile pa ges to those measures th at not only meet the requirements of public reporting such as valid ity, reliability, accuracy, and comparability, but that also are accurately understood and interp reted by consumers as evidenced via consumerCMS-1612-FC 626

testing. This will ensure that the measures presented on Physician Compare help them make

informed health care decisions without overwhelm ing them with too much information. We will

also take into future consideration the reco mmendation regarding the Hospital Compare file. We also received comments regarding stakeh older involvement and consumer testing. Comment: Commenters encouraged continue d involvement of meas ure developers and stakeholders in the public reporting development process. Several commenters appreciated the continued collaboration with spec ialty societies via town hall meetings and other mechanisms. Several commenters advocated for more transpar ency by providing the o pportunity for the public to comment on the deliberations of the Phys ician Compare TEP; regul ar engagement with

interested stakeholders ; and increased communication about th e measure consideration process, including methods and interpretation of performa nce. Some commenters appreciated that CMS

will continue to reach out to stakeholders in the professional community to ensure that the measures under consideration for pu blic reporting remain clinically relevant and accurate. One commenter suggested an opportunity for stakeholde r associations to par ticipate in the 30-day measure preview process. Response: We appreciate the commenters’ feedback regard ing stakeholder outreach and involvement in Physician Compare. As we note d, section 10331(d) of the Affordable Care Act requires that the Secretary take into consider ation input provided by multi-stakeholder groups, consistent with sections 1890(b)(7) and 1890A of the Act, as added by section 3014 of the Act, in selecting quality measures fo r use on Physician Compare. We also are dedicated to providing opportunities for stakeholders to provide input. We will continue to identify the best ways to accomplish this. We will also review all recomm endations provided for future consideration. Comment: Many commenters supported consumer testing to ensure only meaningful

measures are included on the site. One comm enter suggested CMS first focus on communicatingCMS-1612-FC 627

validated and meaningful information in a us er-friendly way. One co mmenter urged CMS to consult a broader array of stakeholders dur ing concept testing, while another commenter specified the inclusion of health care professionals. Some comme nters requested that CMS share with professional associations or measure developers any information obtained through consumer concept testing. A few commenters as ked for more details on concept testing plans, while another recommended CMS use concept te sting for the information currently on the Physician Compare. One commenter emphasized testing must occur prior to placing these

additional measures on the website in late 2016. One commenter believed health care professionals must be aware of what measures will be reported to the Physician Compare website before the reporting period begins. Response: We appreciate the commenters’ feedback. We will continue to conduct consumer testing in terms of both usability testing -- to ensure the site is easy to navigate and functioning appropriately -- and concept testing -- to ensure users understand the information

included on the website and that information include d resonates with health care consumers. We are continually working to test the information planned for public reporting with consumers. We regularly test the information currently on the webs ite with site users. We are planning concept testing of the measures being finalized in this rule prior to publicati on in 2016 and we will work to ensure that valid, reliable, and meaningful in formation is included on the website. This testing

ensures that the best information is shared and that it is shared in a way that is correctly interpreted. We will also engage stakeholders for f eedback, including input from the public, consumers, and health care professionals, as appropriate and feasible through such opportunities as Town Halls, Listening Sessions, Open Door Fo rums, and Webinars. We will review feedback for future consideration. Although we establish in rulemaking the subset of measures availableCMS-1612-FC 628

for posting on the Physician Compare website, at th is time, however, it is not possible for us to provide stakeholders with the exact list of measur es that will be included on the website prior to our analysis of the reported da ta to know which measures meet the criteria we specified previously for public reporting. As is the case for all measures published on Physician Compare, group practices will be given a 30-day preview period to view their meas ures as they will appear on Physician Compare prior to the measures being published. As in pr evious years, we will detail the process for the 30-day preview and provide a detailed timeline a nd instructions for prev iew in advance of the start of the preview period. ACOs will be able to view their qual ity data that will be publicly reported on Physician Compare through the ACO Qu ality Reports, which will be made available to ACOs for review at least 30 days prior to th e start of public reporting on Physician Compare.

Comment: Several commenters were in s upport of the 30-day prev iew period prior to publication of quality data. Many commenters ur ged CMS to also allow group practices, ACOs, and EPs the opportunity to correct and/or appeal any e rrors found in the performance information before it is posted on the website. Severa l commenters recommended CMS postpone posting information if a group practice or EP files an appe al and flags their demographic data or quality information as problematic. Other commenters not ed that a 30-day preview period is insufficient and requested that CMS extend the period to 60 or 90 days. One commenter believed the preview period should match the PQRS committee' s measure review timeline of 9 months. Some commenters sought clarific ation on how CMS plans to notif y EPs of the preview period and requested more detail about correcti ng errors found during the preview period. Response: We appreciate the commenters ’ feedback regarding the 30-day preview period for quality measures on Physician Compar e. Detailed instructions regarding how to preview measure data, the time frame for the measur e preview, and directions for how to addressCMS-1612-FC 629

any concerns or get additional help during this pro cess is shared at the start of the preview period with all groups and individuals th at have data to preview. If an error is found in the measure display during this 30-day preview, the directions explain how to contact the Physician Compare team by both phone and e-mail to have concerns a ddressed. Errors will be corrected prior to publication. If measure data ha s been collected and the measure has been deemed suitable for pubic reporting, the data will be published. This 30- day period is in line with the preview period provided for other public reporting programs such as Hospital Compare. To date, our experience with this preview period for group practices demons trates that 30 days is sufficient time to allow for preview to be conducted. It is important that quality data be shared with the public as soon as possible so it is as current a nd relevant as possible when publis hed. To avoid further delaying this publication we will maintain the 30-day preview period. Group practices and EPs with available data for public reporting will be informed via email when the preview period is going to take place. Group practices and EPs will be provided instructions for previewing data and information for on how to request help or have questions answered. Additionally, inform ation regarding the preview period will be included on the Physician Compare Initiative page on CMS.gov. As noted, ACOs will preview their data via their ACO Quality Reports, which will be sent at least 30 days before data are publicly reported. There is no preview period for demographic data. Th ese data are currently publicly available. If a group practice or EP has quest ions about their demographic data, they should contact the Physician Compare support team at PhysicianCompare@Westat.com. In addition to making all 2015 PQRS GPRO measures available for public reporting, we solicited comment (78 FR 40389) on creating composites using 2015 data and publishing composite scores in 2016 by grouping measures based on the PQRS GPRO measure groups, if technically feasible. We indi cated we would analyze the da ta collected in 2015 and conductCMS-1612-FC 630

psychometric and statistical analyses, looking at how the measures best fit together and how accurately they are measuring the composite con cept, to create composites for certain PQRS GPRO measure groups, incl uding but not limited to:

● Care Coordination/Patient Safety (CARE) Measures

● Coronary Artery Disease (CAD) Disease Module

● Diabetes Mellitus (DM) Disease Module

● Preventive (PREV) Care Measures In particular, we would analyze the compone nt measures that make up each of these measure groups to see if a statistic ally viable composite can be c onstructed with the data reported for 2015. Composite scores have proven to be be neficial in providing co nsumers a better way to understand quality measure data, as composites provide a more concise, easy to understand picture of physician quality. Comment: Commenters were both positive and negative in regard to our request for information on publicly reporting composite scores . Some commenters stated composites should only be publicly reported if statis tically reliable, risk adjusted , or medically meaningful, and should be scientifically or consumer tested prior to public display. A few commenters also suggested NQF endorsement of individual com ponents and composites before finalizing any composites. Several commenters strongly urged CMS to seek input from relevant specialty societies, measure developers, consumers, and ot her stakeholders on the construction and display if the composites. A few commenters opposed p ublic reporting of comp osites, but suggested providing physicians the composite scores confidentially through the QRURs. Several

commenters noted concerns about the proposal to create composite s given the variability in the methodologies, difficulty validating the results, and use of stand-alone measures developed to be reported individually. One commenter suggested stand-alone measures are preferable toCMS-1612-FC 631

composites in relatively small and heterogeneous measure sets. A few commenters suggested posting additional information about composite m easures on Physician Compare clarifying that composite groups are not readily available at this time for all measure groups. One commenter urged CMS to retain more comprehensive informa tion about the measures within each composite

measure in the downloadable file. One commen ter does not specifically support the Oncology Composite Score on Physician Compare. Response: We appreciate the commenters’ feed back on this request for information. We will be carefully reviewing all concerns raised and recommendations made as we continue to evaluate options for including composites in fu ture rulemaking. This concept was put forth merely to seek comment and no formal propos al was made, so we are not finalizing any decisions regarding composite scores at this time . However, given that we received feedback from stakeholders indicating such composite scores are desired, we plan to analyze the data once it is collected to establish the best possible composite, which would help consumers use these quality data to make informed health care decisions, and will consider proposing such composites in future rulemaking. Similar to composite scores, benchmarks are also important to ensuring that the quality data published on Physician Compare are accurately interpreted and appropr iately understood. A benchmark will allow consumers to more easily evaluate the information published by providing a point of comparison between group s. We continue to receive requests from all stakeholders, but especially consumers, to add this informa tion to Physician Compare. As a result, we proposed (79 FR 40389) to publicly report on Ph ysician Compare in 2016 benchmarks for 2015 PQRS GPRO data using the same methodology currently used under the Shared Savings Program. This ACO benchmark methodology was previously finalized in the November 2011 Shared Savings Program final rule (76 FR 67898), as amended in the CY 2014 PFS final ruleCMS-1612-FC 632

with comment period (78 FR 74759). Details on this methodology can be found on CMS.gov athttp://cms.gov/Medicare/Medicare-Fee-for-ServicePayment/sharedsavingsprogram/Downloads/MSSP-QM-Benchmarks.pdf . We proposed to follow this methodology using the 2014 PQRS GPRO data. We proposed to calculate benchmarks using da ta at the group pract ice TIN level for all

EPs who have at least 20 cases in the denomin ator. A benchmark per this methodology is the performance rate a group practi ce must achieve to earn the corr esponding quality points for each

measure. Benchmarks would be established for each percentile, starting w ith the 30th percentile (corresponding to the minimum attainment le vel) and ending with the 90th percentile (corresponding to the maximum attainment level). A quality scoring point system would then be determined. Quality scoring would be based on the group practice’s actual level of performance on each measure. A group practice would earn quali ty points on a sliding scale based on level of performance: performance below the minimum a ttainment level (the 30th percentile) for a measure would receive zero points for that measur e; performance at or above the 90th percentile of the performance benchmark would earn the ma ximum points available for the measure. The total points earned for measures in each measure group would be summed and divided by the total points available for that measure group to produce an overall measure group score of the percentage of points earned versus points available. The percentage score for each measure group would be averaged togeth er to generate a final overa ll quality score for each group practice. The goal of including such benchmar ks would be to help consumers see how each group practice performs on each measure, measur e group, and overall in relation to other group practices. Comment: Many commenters supported the use of benchmarks to help consumers make informed health care decisions. However, seve ral commenters did not support the calculation ofCMS-1612-FC 633

an overall quality score, as they believe it wi ll result in the unfair comparison of all group practices. Additional commenters noted that benchmarks using percentiles will be difficult for consumers to understand and encouraged consum er testing to remedy this problem. Some commenters noted appropriate methodology is needed when potential data constraints impact the

calculation of benchmarks. Seve ral commenters also asked for clarification on the impact of exception rates on quality scores and how benchmarks will be displayed, noting the risk of arbitrary thresholds potentially exaggerating minor performance differences. A commenter asked for the opportunity to review sample da ta prior to supporting the proposed methodology,

while another noted that benchmarks need to be set prior to the beginning of the new measurement period. One commenter sought clarification on whet her the benchmarking methodology would be the same as the methodology applied under the Value-Modifier. Several commenters urged CMS to use consistent be nchmarking across its programs to promote consistency and minimize confusion. One comment er cautioned the use of benchmarks, noting it can lead to an incomplete and potentially misleading indicator of quality. Response: We appreciate the commenters ’ feedback on our proposal to include on Physician Compare a benchmark for 2015 PQRS GPRO measures (and measures reported by individual EPs) measures based on the cu rrent Shared Savings Program benchmark methodology. Although we agree benchmarks can a dd great value for consumers, we understand the many concerns raised. As a result, we have made a decision not to finalize this proposal at

this time. We want to be sure to discuss more thoroughly potential benchmarking methodologies with our stakeholders prior to fi nalizing the proposal. We also wa nt to evaluate other programs’ methodologies, including the Value Modifier, to work toward bette r alignment across programs. We therefore feel it would be best to forego fi nalizing a methodology at this time in favor of a stronger, potentially better al igned methodology that can be in cluded in future rulemaking.CMS-1612-FC 634

Understanding the value consumers place on pa tient experience data and the commitment to reporting these data on Physician Compare, we proposed (79 FR 40390) publicly reporting in CY 2016 patient experience data from 2015 for a ll group practices of two or more EPs, who meet the specified sample size requirements a nd collect data via a CM S-specified certified CAHPS vendor. The patient experience data av ailable are specifically the CAHPS for PQRS and CAHPS for ACO measures, which includ e the CG-CAHPS core measures. For group practices, we proposed to make available fo r public reporting thes e 12 summary survey

measures:

● Getting Timely Care, Appointments, and Information.

● How Well Provi ders Communicate.

● Patient’s Rating of Provider.

● Access to Specialists.

● Health Promo tion & Education.

● Shared Decision Making.

● Health Status/Functional Status.

● Courteous and Helpful Office Staff.

● Care Coordination.

● Between Visit Communication.

● Helping You to Take Medication as Directed.

● Stewardship of Patient Resources. We proposed that these 12 summary survey measures would be available for public reporting for all group practices. For ACOs par ticipating in the Shared Savings Program, we proposed (79 FR 40390) that the patient expe rience measures that are included in the Patient/Caregiver Experience domain of the Qu ality Performance Standard under the SharedCMS-1612-FC 635

Savings Program in 2015 would be available for public reporting in 2016. We would review all quality measures after they are collected to ensu re that only those measures deemed valid and

reliable are included on the website.

We received a number of comments around our proposals to include CAHPS measures on Physician Compare. Comment: Several commenters supported our proposal to publicly report CAHPS for PQRS data for all group practices that have met the minimum sample size requirements and collect the data using a certified CMS-approve d vendor. One commenter strongly encouraged CMS to make public reporting on patient experien ce measures mandatory for groups of all sizes and individual EPs. However, a few commen ters were concerned wi th public reporting of CAHPS or other patient experience survey data due to the subjectivity of the surveys or the cost of administering the surveys. Response: We appreciate the commenters’ feedback. At this time reporting of CAHPS measures for PQRS is only available at the group practice level, so we will continue to consider these data for group practices. We understand th e concerns raised regarding subjectivity and cost. However, we are confident that CAHP S is a well-tested collection mechanism that produces valid and comparable measures of physic ian quality based on the extensive testing and work that has been done by the Agency for H ealthcare Research and Quality's (AHRQ) and specifically the CAHPS Consortium (for more in formation visit https:// cahps.ahrq.gov/). This work illustrates that these measures are accurate measures of patient experience. Because CAHPS for PQRS can be one part of a group’s participation in PQRS and are data greatly desired by consumers, we also believe concer ns regarding cost are outweighed. For these reasons, we are finalizing our proposal to make available fo r public reporting the 12 summaryCMS-1612-FC 636

survey CAHPS measures outlined in this rule on Physician Compare for group practices and ACOs, as appropriate. Comment: Commenters were generally supportiv e of the proposal to publicly report 12 summary CAHPS scores; however, some are con cerned that several CAHPS summary survey measures cannot accurately capture aspects of ca re over which an individual physician does not have direct control, such as “Getting Timely Care, Appointment s and Information” and “Access to Specialists,” and urged CMS to only report th ese measures on an aggregate, group level.

Another commenter is concerned with “Stewardsh ip of Patient Resources” survey measure, noting that it is not a physician’s role to manage a patient’s po cketbook and that other barriers, apart from costs, can impede access to care. One commenter supported the creation of be nchmarks for CAHPS for PQRS measures, and suggested CMS clarify whether those benchmarks will be the same as the ACO CAHPS measure benchmarks, or whether the benchmarks will be specific to the PQRS program, but calculated using the same methodology. Response: The CAHPS for PQRS measures are designed to be group-level measures.

These data will not be calculated for individual EPs; they will be evaluated at the group practice level. We do appreciate the co mmenters’ feedback regarding conc erns over specific measures. One important consideration is that because the CAHPS measures are group-level, they are not attributing aspects of care to an individual EP, as not all aspects of care can be easily attributed to a single professional. Prior to deciding the specific measures that will be publicly reported on Physician Compare, we will ensure the measures meet the reliability and validity requirements set for public reporting and that the measures are understood and accu rately interpreted by consumers. If a summary survey measure does not meet these criteria, it will not be publiclyCMS-1612-FC 637

reported on Physician Compare. At this time, we are not adopting any benchmarks for CAHPS for PQRS on Physician Compare. Comment: One commenter sought additiona l information on how CAHPS for PQRS performance measures will be displayed. Anothe r commenter suggested that public reporting of CAHPS for PQRS utilize the Hospital Compare model by displaying aggregate scores for

measures with a footnote or click-thr ough option to view the performance data. Response: We appreciate the commenters’ feedback regarding di splay of CAHPS for PQRS measures. We generally make decisions a bout measure display after consumer testing and stakeholder outreach, so we will take these recommendations into consideration. We previously finalized in the 2014 PFS fi nal rule with comment period (78 FR 74454) that 20 measures in the 2014 PQRS measures for individual EPs collected via registry, EHR, or claims would be available for public reporting in late 2015, if technically feasible. We proposed (79 FR 40390) to expand on this in two ways. Fi rst, we proposed to publicly report these same 20 measures for 2013 PQRS data in early 2015. We stated that publicly reporting these 2013 individual measures would help ensure individual level measures are made available as soon as possible. We believe that consumers are looki ng for measures about individual doctors and other health care professionals, and this would make th ese quality data available to the public sooner. Comment: One commenter supported our pr oposal to publicly report 20 individual EPlevel 2013 PQRS measures in early 2015, while another commenter opposed the proposal noting that physicians were unaware at the time of data collection that these performance rates would be published. Concerns were raised that timelines n eeded to be finalized before the public reporting period had ended.CMS-1612-FC 638

Response: We appreciate the commenters’ feedback and understa nd concerns that the 2013 individual EP PQRS data were submitted w ithout an explicit understa nding that these data would be made public. As a result, we are not finalizing this proposal. Second, we proposed (79 FR 40390) to make all individual EP-level PQRS measures collected via registry, EHR, or claims availa ble for public reporting on Physician Compare for data collected in 2015 to be publicly reporte d in late CY 2016, if technically feasible. 9 We stated that this would provide the opportunity for more EPs to have measures included on Physician Compare, and it would provide more informati on to consumers to make informed decisions

about their health care. As w ith group-level measures, we pr oposed to publicly report all

measures submitted and reviewed and deemed va lid and reliable in the Physician Compare downloadable file. However, not all of these measures necessarily w ould be included on the Physician Compare profile pages. Our analys is of the reported measure data, along with consumer testing and stakeholder feedback, w ould determine specifically which measures are published on profile pages on the website. In this way, quality information on individual practitioners would be available, as has b een regularly requested by Medicare consumers, without overwhelming consumers with too much information.

Comment: Some commenters supported expanding public re porting of individual-level quality measures to all 2015 PQ RS measures collected through a Registry, EHR, or claims, noting consumers are looking for in dividual doctors so this inform ation is helpful. Several commenters opposed making 2015 PQRS individual EP measures available for public reporting

in 2016 and are concerned that individual quality measurement is technically challenging to validate and may be difficult for consumers to understand. Another commenter suggested it is

9 Tables Q1-Q27 detail proposed changes to available PQRS measures. Additional information on PQRS measures can be found on the CMS.gov PQRS website at http://www.cms.gov/Medicare/Quality-Initiatives-PatientAssessment-Instrume nts/PQRS/index.html

.CMS-1612-FC 639

too much information for consumers. One commente r stated that data repo rted through different reporting mechanisms is not comparable so th is proposal should not be finalized. One commenter believed that the relatively small numbe rs of patients seen by individual physicians raises questions about the ability to truly di fferentiate quality. Se veral commenters supported group practice level public repo rting as an altern ative to individual public reporting. Response: We appreciate the commenters’ feedback and agr ee with those comments that support individual-level measure data should be posted on the site as soon as technically feasible. We also strongly agree with comm enters that these data will he lp health care consumers make informed decisions about the care they receive. However, we appreciate the concerns raised by other commenters’ in opposition to posting individual EP measures. We are committed to including only the most accurate, statistically reliable, and valid quality of care measure data on Physician Compare. We will also ensure that only those data that are evaluated to be comparable will be publicly reported understanding the conc erns regarding data collected via different reporting mechanisms.

We will continue to test the PQRS measures with consumers to ensure the measures are presented and described in a way that is accurately understood. We will only include on the

website those measures that resonate with cons umers to ensure they are not overwhelmed with too much information. Regarding concerns around the number of patients seen, only those measures that are reported for the accepted samp le size of 20 patients will be publicly reported. Because of the overwhelming consumer demand for individual EP data and the value these data provide to patients, we are fi nalizing our proposal to publicly report all 2015 individual EP PQRS measures collected through a Registry, EHR, or claims, ex cept for those measure that are new to PQRS and thus in their first year.CMS-1612-FC 640

As noted above for group-level reporting, co mposite scores and benchmarks are critical in helping consumers best understand the qual ity measure information presented. For that reason, in addition to making all 2015 PQRS measur es available for public reporting, we sought comment (79 FR 40390) to create composite s and publish composite scores by grouping measures based on the PQRS measure groups, if t echnically feasible. We indicated that we would analyze the data collected in 2015 and c onduct psychometric and statistical analyses to create composites for PQRS measure groups to be published in 2016, including:

● Coronary Artery Dise ase (CAD) (see Table 30)

● Diabetes Mellitus (DM) (see Table 32)

● General Surgery (see Table 33)

● Oncology (see Table 38)

● Preventive Care (see Table 41)

● Rheumatoid Arthritis (RA) (see Table 42)

● Total Knee Replacement (TKR) (see Table 45) We would analyze the component measures th at make up each of these measure groups

to see if a statistic ally viable composite can be construc ted with the data reported for 2015. As noted for group practices, we believe that providi ng composite scores will give consumers the tools needed to most accurately interpret the qua lity data published on Physician Compare. We would analyze the component measures that make up each of these measure groups to see if a statistically viable composite can be cons tructed with the data reported for 2015. As noted above, we received multiple comments about creating composites at both the group practice and individual EP-level. Those co mments are addressed a bove. Since we were only seeking comments on possible future composites, we are not finalizing any at this time, but

we will take those comments into consideration for the future.CMS-1612-FC 641

In addition, we proposed (79 FR 40390) to use the same methodology outlined above for group practices to develop benchmarks for indivi dual practitioners. We believe that providing benchmarks will give consumers the tools needed to most accurately interpret the quality data published on Physician Compare. As discusse d above, we received comments on the proposed benchmarking methodology for both group practices a nd individual EPs. Those comments were previously addressed. As noted, we are not finalizing this proposed benchmarking methodology

at this time. Previously, we indicated an in terest in including specialty society measures on Physician Compare. In the proposed rule, we solicited comment (79 FR 40390) on posting these measures

on the website. We also solicited comment on th e option of linking from Physician Compare to specialty society websites that publish non-PQ RS measures. Including specialty society measures on the site or linking to specific specialty society measures would provide the opportunity for more eligible prof essionals to have measures included on Physician Compare and thus help Medicare consumers make more inform ed choices. The quality measures developed by specialty societies that would be considered fo r future posting on Physician Compare are those that have been comprehensively vetted and test ed and are trusted by th e physician community. These measures would provide acce ss to available specialty specif ic quality measures that are often highly regarded and trus ted by the stakeholder community and, most importantly, by the specialties they represent. We indicated that we were working to identify possible societies to reach out to, and solicited comment on the concept, as well as potential sp ecific society measures

of interest. Comment: Many commenters supported sp ecialty society measures on Physician Compare or linking to specialty society websites that publis h non-PQRS measures. Several commenters specified that the specialty societ y measures should be s upported by scientificCMS-1612-FC 642

evidence, developed by relevant clinical expert s, and adequately vett ed. Some commenters suggested a disclaimer specifying, along with th e measure description, th e limitations of PQRS or clarification that CMS is not endorsing and ha s not validated specialty society measures. One commenter supported specialty measures as long as data is open source d, provided at no cost,

and made available to all. On e commenter suggested also incl uding links to additional patientfriendly educational materials on sp ecialty societies’ websites. Several commenters opposed posting non-PQRS data or linking to non-governmental, privately managed websites. One commenter st ated CMS should maintain control over the public disclosure process to reduc e potential for variable data. One commenter is concerned that the approach will lead to more confusion for consumers and added burden for physicians, and

another commenter cautioned CMS to ensure meas ures that are meaningf ul to consumers and comparable to those reported upon under th e PQRS. A few comment ers sought additional information on this process if this become s a formal proposal in future years. Response: We appreciate commenters’ fee dback on our request for information. We were only seeking comment at this time. We will consider feedback, recommendations made, and concerns raised, and may cons ider addressing specialty soci ety measures and website links on Physician Compare in future rulemaking. Finally, we proposed (79 FR 40390) to ma ke available on Physician Compare, 2015 Qualified Clinical Data Registry (QCDR) meas ure data collected at the individual level or aggregated to a higher level of the QCDR’s c hoosing – such as the group practice level, if technically feasible. QCDRs are able to coll ect both PQRS measures and non-PQRS measures. 10 We believe that making QCDR data availabl e on Physician Compare further supports the expansion of quality measure data available for EPs and group practices regardless of specialty

10 http://www.cms.gov/apps/ama/license.asp?file=/PQRS/do wnloads/2014_PQRS_IndClaim sRegistry_MeasureSpec s_SupportingDocs_12132013.zipCMS-1612-FC 643

therefore providing more quality data to consumer s to help them make informed decisions. Per the proposal, the QCDR would be re quired to declare during their self -nomination if they plan to post data on their own website and allow Physician Compare to link to it or if they will provide data to CMS for public reporting on Physician Comp are. We proposed that measures collected via QCDRs must also meet th e established public reporting cr iteria, including a 20 patient minimum sample size. As with PQRS data, we proposed to publicly report in the Physician Compare downloadable file all measures submitte d, reviewed, and deemed valid and reliable. However, not all of these measures necessari ly would be included on the Physician Compare profile pages. Our analysis of the reported measure data, along with consumer testing and stakeholder feedback would determine specifica lly which measures are published on profile pages on the website. Comment: We received many comments on publicly reporting 2015 QCDR measure data. Some commenters supported publicly repor ting QCDR data to provide specialty-specific quality information for patients. One commenter proposed CMS consumer test QCDR measures to ensure valid sampling, consistent methods, and comparable results across specialties. A number of commenters did not support the proposal, however. Most notably, commenters believed that public reporting firs t year data for new measures would be problematic. Other commenters opposed publ icly reporting QCDR data until accurate benchmarking data can be devel oped, or professionals have the opportunity to analyze the data and make improvements. Several commenters requested NQF endorsement for all QCDR measures, and one commenter suggested that CM S develop rules and guidelines for measure stewards who develop non-PQRS measures housed in QCDR’s. One commenter stated societysponsored non-PQRS measures n eed to be subjected to the same reliability, validity, and consumer testing that CMS promises for othe r information on Physician Compare. AnotherCMS-1612-FC 644

commenter noted that QCDR measures are collec ted for quality improvement purposes and have not been vetted for public reporting. Response: We appreciate the commenters’ feedback on our proposal to include all 2015 QCDR data at the individual level or aggregated to a higher level of th e QCDR’s choosing. We understand the many concerns raised . We specifically appreciate the concerns that the QCDR non-PQRS measures be held to the same standards as the PQRS measures in terms of reliability, validity, and accuracy, and that these measures be adequately tested and vetted for public reporting. Understanding these concerns, we will review all data prior to public reporting to

ensure that the measures included meet the same standards as the PQRS measures being publicly reported. As with the PQRS measures being made available for public reporting, if the QCDR measures do not meet the requirements for public reporting we have set out, the measures will not be publicly reported. Regarding the comm ent that QCDR data s hould not be publicly reported until accurate benchmarks are availabl e, we appreciate this concern but are moving forward with the proposal because we believe th at even without benchmarks, these data can provide consumers with very valuable and inst ructive information as is the case, and thus consistent, with the PQRS measures we are fi nalizing for publication w ithout a benchmark. We do feel it is important to include QCDR data in our public reporting pl an, as some commenters agreed, because using QCDR data can ultimatel y provide an opportunity to have measures available for public reporting for a greater number of health care profes sionals covering more specialties, providing more and more useful info rmation to health care consumers. We are therefore finalizing our proposal to publicly report QC DR measures with some modifications. We agree that it may be problematic to public ly report first year measures. Health care professionals should be afforded the opportunity to simply learn fr om the first year data, and not have this information shared publicly until the m easure can be vetted for accuracy. As a result,CMS-1612-FC 645

we will not publicly report any QCDR measures newly available for reporting for at least one year. This is consistent with the VM policy regarding first year measures and addresses a significant number of the concerns raised, which were specifically in regard to not including first year measures for public reporting. If first year measures are not publicly reported this will provide us the necessary time to review and vet the QCDR measures to ensure that only those truly suitable for public reporting are poste d on Physician Compare when they mature.

Comment: A number of commenters consid ered the proposed timeline for publicly reporting 2015 QCDR measure data t oo aggressive to ensure that da ta will be valid and reliable and in a format which consumers can understand; some suggested delaying or implementing a gradual approach. A few commenters were conc erned public reporting so soon will damage start up efforts of new registries. Several commenters supported the proposal only if the QCDR measures are posted on Physician Compare. One commenter believed th is will streamline the public reporting process. One commenter noted that QCDR s websites are not intended for public consumption and would require new infrastructure, while another commenter was concerne d with a potential conflict of interest by linking to nongovernmental websites. Two commenters support linking to the QCDR

websites to view the data to reduce consumer confusion. Anot her commenter urged consistent and uniform public reporting. Response: We appreciate the commenters’ feedback and do acknow ledge the concerns regarding the timeline. To mitigate some of th ese concerns, we are adopting some refinements to what we proposed, such as not reporting firs t year measures. We belie ve that not publicly reporting measures on Physician Compare that are not ready for public reporting will help QCDRs early in their development and not reflec t negatively on the new QCDR. We are also finalizing a decision to publish QCDR 2015 data on the Physician Compare website in 2016.CMS-1612-FC 646

However, as finalized in the PQRS section of th is rule, we are not requ iring these data to be publicly reported on the QCDR we bsites in order to address con cerns that there is not enough time for QCDRs to establish user-f riendly websites for sharing data as well as concerns about data consistency. Publicly reporting the QCDR data on Physician Compare also provides a uniform public reporting approach, eliminates the need for health care professionals to verify their data in multiple locations, and provides one , user-friendly website for consumers trying to locate quality data. After this first year of pubic reporting QCDR data, we will evaluate if maintaining this policy is most desirable. Comment: A few commenters supported reporti ng individual or data aggregating to a higher level, but the majority recommend QCDR measure data only be reported on Physician Compare at the group practice leve l. One commenter suggested requiring the individual level data to be made publicly available, so long as results are valid and reliable. One commenter believed QCDRs should have the option to public ly disclose performance data by physician specialty within a group, in addition to at the individual or group levels. Response: We appreciate the commenters’ feedback. As stated above, only those data that are deemed valid, reliable, and accurate wi ll be publicly reported on Physician Compare. This will be true for all QCDR data as well. Given that we will publish QCDR data on Physician Compare, but not first year measures, this will en able us to review and vet the QCDR measures prior to public reporting in 2016. In this way, we can ensure on ly the most appropriate available QCDR measures are publicly repo rted, and that they are report ed in a way that will help

consumers make informed decisions. QCDR data will only be publicly reported at the individual-EP level. We appreciate the commenters’ concerns and support for group-level da ta. However, QCDR data is not necessarily aggregated to a level consistent with how PQRS defines a group practice. Therefore, aggregatedCMS-1612-FC 647

data cannot be accommodated on Physician Co mpare at this time. And, under PQRS, only individual EPs can report via a QCDR. Therefore, only including individu al-level QCDR data on Physician Compare is consistent with the PQRS program’s implementation of the data. As with all data included on Physician Compare, only data deemed valid, reliable, and accurate will be publicly reported on the website. Table 49 summarizes the Physician Compare pr oposals we are finalizing for with regard

to 2015 data. TABLE 49: Summary of Finalized Data for Public Reporting Data Collection Year Publication Year Data Type Reporting Mechanism Finalized Proposals Regarding Quality Measures and Data for Public Reporting 2015 2016 PQRS, PQRS GPRO, EHR, and Million Hearts Web Interface, EHR, Registry, Claims Include an indicator for satisfactory reporters under PQRS, participants in the EHR Incentive Program, and EPs who satisfactorily report the individual PQRS Cardiovascular Prevention measures in support of Million Hearts.

2015 2016 PQRS GPRO & ACO GPRO Web Interface, EHR, Registry, and Administrative Claims All 2015 PQRS GPRO meas ures reported via the Web Interface, EHR, and Registry that are available for public reporting for group practices of 2 or more EPs and all measures reported by ACOs with a minimum sample size of 20 patients. 2015 2016 CAHPS for PQRS& CAHPS for ACOs CMSSpecified Certified CAHPS Vendor 2015 CAHPS for PQRS for groups of 2 or more EPs and CAHPS for ACOs for those who meet the specified sample size requirements and collect data via a CMS-specified certified CAHPS vendor. 2015 2016 PQRS Registry, EHR, or Claims All 2015 PQRS measures for individual EPs collected through a Regi stry, EHR, or claims. 2015 2016 QCDR data QCDR All individual-EP level 2015 QCDR data.

4. Additional Comments Received Beyond the Scope of this Rulemaking We received comments regarding the availabi lity of measures at the individual and group-levels for certain types of specialties and for other health car e professionals, but that were beyond the scope of this rule. We have summ arized and addressed those comments below.

Comment: Several commenters are concerned a bout the availability of specialty-specific and non-physician measures availa ble for public reporting due to th e proposed removal of PQRSCMS-1612-FC 648

measures and/or limitations of measures repo rted via claims or the Web Interface. Two commenters noted that some speci alty specific measures are not suitable for public reporting, as the data is not meaningful to consumers. Comm enters also noted that the absence of measure data on Physician Compare due to limited avai lable or meaningful measures may mislead consumers. Commenters requested disclaimers be added or additional education be conducted to explain that there could be the absence of measure data due to measure limitations and not poor quality. Several commenters expressed concern with publicly reporting any data until measure limitations can be analyzed or addressed. Tw o commenters supported the continued work of CMS with professional societies to address measure concerns. Response: We appreciate the commenters’ feed back. We understand that availability of PQRS measures may make it difficult for some specialties to report. We hope that the introduction of additional measures, such as QC DR measures and patient experience measures, will help mitigate concerns rega rding quality data availability in the short term. And, it is important to realize that as most searches on P hysician Compare are specialty based, if there are not measures for a given specialty, users will not be evaluating some physicians or nonphysicians with measures and some without within that specialty. That can also work to mitigate these concerns. Finally, we also understand that disclaimers a nd other types of explanatory language are necessary to help inform health care consumers as they use the website. We will continue to work to ensure that the langua ge included on Physician Compare addresses the concerns raised and helps users understand that there are a number of reasons a physician or other health care professional may no t have quality data on the website. Comment: We received comments on how qualit y measures are displayed on Physician Compare. Several commenters opposed star ranki ngs or similar systems and are concerned that disparate quality scores will result in inappropr iate distinctions of qua lity for physicians whoseCMS-1612-FC 649

performance scores are not statistically different . One commenter suggested increased efforts to establish the best method for presenting performa nce information to consumers and to educate consumers on the meaning of performance differences. Response: At the time this rule is fi nalized, Physician Compare does not employ a ranking system – the site does not provide a system that determines that one professional is better than other professionals based on any set of defined criteria. Pe rformance scores are displayed visually using five stars as a pi ctographic representation of the pe rcent. In this way, each star represents 20 percentage points. The performance rate is also displayed as a percent. Consumer testing has shown that this display is most accurately understood and interpreted by website users. Stakeholders were provided opportunitie s to view alternate di splay options and this display was also supported by a majority of those who took part in review sessions prior to the initial publication of measure data. That said, we intend to continue to work with consumers and stakeholders to find the best way to display da ta that will best serve consumers and most accurately represent the data.

Comment: Several commenters are concerned with the use of physician-centric language in the proposed rule and on Physic ian Compare, noting that the name of the site could be more inclusive of all eligible h ealth care professionals. One commenter suggested providing information throughout the website about the fu ll array of qualified professionals. One commenter requested the definition of the Clin ical Nurse Specialist change, while another specified changes for Registered Dietitian/Nutr ition Professionals. One commenter asked CMS to assure that audiologists are meaningfully represented and can be easily identified by other professionals and patients. One commenter recommended that the enrollment application process also be refined to provide a provider neutral enrollment process. Response: We appreciate the commenters’ feedback, and will take all recommendationsCMS-1612-FC 650

into consideration for the future. The site was named consistent with section 10331 of the Affordable Care Act. Throughout the site we note that both physicians and other health care professionals are available to search and view. If a professional is in approved status in PECOS and has submitted Medicare Fee-For-Service claims in their name in the last 12 months, they will be included on Physician Compare. We are al ways working to ensure the plain language definitions of the various types of professionals included on the site are accurate and up-to-date.

We will review the recommendations made around this information and work with relevant stakeholders to upda te as appropriate. Comment: Commenters provided suggestions for additional information to publicly report on Physician Compare, including participat ion in a quality improvement registry for certain services, fellowship stat us, other voluntary quality impr ovement initiatives, educational materials about a disease or procedure, special ist-specific training and certification data, and other qualifications, such as the Certified Medi cal Director designation and the Certificate of Added Qualifications in Geriat ric Medicine. One commenter s upported inclusion of information about physician compliance with Medicare rule s. Another commenter suggested including

measures related to cancer care. Response: We appreciate the commenters’ feedback and recommendations for including

additional information on the website. We w ill review all recommendations provided and evaluate the feasibility for potential inclus ion in the future. One im portant consideration around many of these recommendations is whether there is a readily available nationa l-level data source. With this in mind, the recommendations will be closely evaluated.

Comment: Several commenters noted the lim itations of CAHPS for PQRS measures for some health care professionals and supported addi ng other types of patient experience data to Physician Compare, including the Surgical CAH PS® and experience data collected via otherCMS-1612-FC 651

sources. One commenter suggested publicly repo rting beneficiary satisfa ction information in addition to CAHPS for PQRS measures. Another commenter suggested reporting patient experience data for primary care physicians and clinical quality perfor mance for specialists. Response: We appreciate the commenters’ feedback. We ag ree that Surgical CAHPS® data is useful to consumers and we are explori ng how we can incorporate this information into Physician Compare. Comment: One commenter encouraged CMS to recognize improvements by individual professionals and groups over time, while another noted the benefits of cross-sectional and crosstime comparisons. Response: We appreciate the commenters’ feedback and the recommendation to consider longitudinal as well as other comparisons. We w ill evaluate these recommendations as we move forward with Physician Compare. Comment: One commenter suggested that th e measures being removed from PQRS due to 100 percent performance be added to the Ph ysician Compare website as display measures believing that these topped out measures w ould add value to Physician Compare. Response: We appreciate the commenter’s feedback. However, if the measure data are no longer going to be reported in PQRS, these data will not be available to consider for posting on Physician Compare. Comment: One commenter urged CMS to crea te mechanisms to attribute Medicare Advantage quality data to phys ician groups for display on Physician Compare and enable

CG-CAHPS vendors to include bene ficiaries enrolled in MA, as we ll as in traditional Medicare

fee-for-service. Response: We appreciate the commenters’ s uggestions and will evaluate the feasibility

of these recommendations for the future.CMS-1612-FC 652

5. Report to Congress Section 10331(f) of the Affordable Care Ac t, requires that no later than January 1, 2015, we submit a report to Congress on the Physician Compare website that includes information on the efforts of and plans made by th e Secretary of Health and Human Services to collect and publish data on physic ian quality and efficiency and on patient experience of care in support of consumer choice and value-based purcha sing. We anticipate timely submission of this report, including discussion about the phase-in of the website and developments to date. The report will also address the expansio n of data on the website, in re gard to section 10331(g) of the Affordable Care Act, and future plans for the website.CMS-1612-FC 653

K. Physician Payment, Efficiency, and Quality Improvements – Physician Quality Reporting System This section contains the requirements for the Ph ysician Quality Reporting System (PQRS). The PQRS, as set forth in sections 1848(a), (k), and (m ) of the Act, is a quality reporting program that provides incentive payments (ending with 2014) and payment adjustments (beginning in 2015) to eligible professionals and group practices based on whether they satisfactorily report data on quality measures for covered professional services furnished during a speci fied reporting period or to individual eligible professionals that satisfactorily participate in a qualified clinical data registry (QCDR). The requirements in this rule primarily focus on the 2017 PQRS payment adjustment, which will be based on an eligible professional’s or a group prac tice’s reporting of quality measures data during the 12-month calendar year reporting period occurring in 2015 (that is, January 1 through December 31, 2015). Please note that, during the comment period, we received comments that were not related to our specific proposals for the requirements for the 20 17 PQRS payment adjustment in the CY 2015 PFS proposed rule. While we appreciate the commenters’ feedback, these comments will not be specifically addressed in this CY 2015 PFS final rule with comment pe riod, as they are beyond the scope of this rule. However, we will consider these comments when developing policies and program requirements for future years. Please note that we continue to fo cus on aligning our requirements with other quality reporting programs, such as the Medicare EHR Incenti ve Program for Eligible Professionals, the VM, and the Medicare Shared Savings Program, where and to the extent appropriate and feasible. The PQRS regulations are located at §414.90. The program requirements for the 2007 through 2014 PQRS incentives and the 2015 and 2016 PQRS payment adjustment that were previously established, as well as information on the PQRS, includi ng related laws and established requirements, are

available at http://www.cms.gov/Medicare/Quality-Initiatives-Patient-AssessmentInstruments/PQRS/index.html . In addition, the 2012 PQRS and eRx Experience Report, which provides information about eligible professional participa tion in PQRS, is available for download at http://www.cms.gov/Medicare/Quality -Initiatives-Patient-AssessmentInstruments/PQRS/Downloads/2012-PQ RS-and-eRx-Experience-Report.zip

.CMS-1612-FC 654

We note that eligible professionals in critical access hospitals billing under Method II (CAH-IIs) were previously not able to participate in the PQRS . Due to a change we made in the manner in which Medicare reimburses eligible professionals in CAH-IIs, it is feasible for eligible professionals in CAH-IIs to participate in the PQRS for reporting beginning in 2014. Although eligible professionals in CAH-IIs are not able to use the claims-based reporting mech anism to report PQRS quality measures data in 2014, beginning in 2015, these eligible professionals in CAH-IIs may participate in the PQRS using ALL reporting mechanisms available, including the claims-based reporting mechanism. Finally, please note that in accordance with section 1848(a)(8) of the Act, all eligible professionals who do not meet the criteria for satisfactory reporting or satisfactory pa rticipation for the 2017 PQRS payment adjustment will be subject to the 2017 PQRS payment adjustment with no exceptions. In addition, in the CY 2013 PFS final rule with comment period, we introduced the reporting of the Agency for Healthcare Research and Qualit y’s (AHRQ’s) Clinician & Group (CG) Consumer Assessment of Healthcare Providers and System s (CAHPS) survey measures, referenced at https://cahps.ahrq.gov/Surve ys-Guidance/CG/index.html . AHRQ's CAHPS Clinician & Group Survey Version 2.0 (CG-CAHPS) includes 34 core CG-CAHPS su rvey questions. In addition to these 34 core questions, the CAHPS survey measures that are used in the PQRS include supplemental questions from CAHPS Patient-Centered Medical Home Survey, Core CAHPS Health Plan Survey Version 5.0, other CAHPS supplemental items, and some additional questions. Since the CAHPS survey used in the PQRS covers more than just the 34 core CG-CAHPS surv ey measures, we will refer to the CG-CAHPS survey measures used in the PQRS as “CAHPS for PQRS.” We proposed to make this revision throughout §414.90. We did not receive comments on referring to the CG-CAHPS survey measures as reported in the PQRS as CAHPS for PQRS, and are theref ore finalizing this proposal as proposed. 1. Requirements for the PQRS Reporting Mechanisms The PQRS includes the following reporting mech anisms: claims; qualified registry; EHR (including direct EHR products a nd EHR data submission vendor pr oducts); the Group Practice Reporting Option (GPRO) web interface; certified survey vendo rs, for the CAHPS for PQRS survey measures; and the QCDR. Under the existing PQRS regulation, §414.90(h) through (k) govern which reportingCMS-1612-FC 655

mechanisms are available for use by individuals and group practices for the PQRS incentive and payment adjustment. This section III.K.1 contains our proposal s to change the qualified registry, direct EHR and EHR data submission vendor prod ucts, QCDR, and GPRO web interface reporting mechanisms, as well as public comments and our final decisions on those proposals. Please note that we did not propose to make changes to the claims-based reporting mechanism. Please note that, in the CY 2015 PFS proposed rule , we solicited comments on whether, in future years, we should allow for more frequent submissions , such as quarterly or year-round submissions, for PQRS quality measures data submitted via the qualif ied registry, EHR, QCDR, and GPRO web interface reporting mechanisms (79 FR 40392, 40393, and 403 95 respectively). Many commenters supported this concept, as it would provide vendors and their products greater flexibility in data submission. However, some of these commenters who expressed support for mo re frequent submissions of data preferred that the ability to provide more frequent submission of da ta be optional, not mandatory. We appreciate the commenters’ support for this concept and will consid er the commenters’ feedback if and when we propose this policy in future rulemaking. a. Changes to the Requirements for the Qualified Registry

In the CY 2013 and 2014 PFS final rules with comment period, we established certain requirements for entities to become qualified registri es for the purpose of verifying that a qualified registry is prepared to submit data on PQRS qua lity measures for the reporting period in which the qualified registry seeks to be qualified (77 FR 69179 through 69180 and 78 FR 74456). Specifically, in the CY 2014 PFS final rule with comment period, in accordance with the satisfactory reporting criterion we finalized for individual eligible professionals or group practices reporting PQRS quality measures via qualified registry, we finalized the following requirement that a qualified registry must be able to collect

all needed data elements and transmit to CMS the data at the TIN/NPI level for at least 9 measures covering at least 3 of the National Quality Strategy (NQS) domains (78 FR 74456). As we explain in further detail in this section III. K, we proposed that – in addition to requiring that an eligible professional or group practice repor t on at least 9 measures covering 3 NQS domains –an eligible professional or group practice who sees at le ast 1 Medicare patient in a face-to-face encounter, asCMS-1612-FC 656

we define that term in section III.K.2.a., and wishes to meet the criterion for satisfactory reporting of PQRS quality measures via a qualified registry for th e 2017 PQRS payment adjustment would be required to report on at least 2 cross-cutting PQRS measures specified in Table 52. In accordance with this proposal, we proposed to require that, in addition to be ing required to be able to collect all needed data elements and transmit to CMS the data at the TIN/NPI level for at least 9 measures covering at least 3 of the NQS domains for which a qualified registry transmits data, a qualified registry would be required to

be able to collect all needed data elements and tr ansmit to CMS the data at the TIN/NPI level for ALL cross-cutting measures specified in Table 52 for which the registry’s participating eligible professionals are able to report. Comment: Some commenters opposed this proposed requirement, stating that this requirement seems overly burdensome. The commenters noted that, in some instances, certain registries report PQRS quality measures data for certain specialties for whic h the proposed cross-cutting measure set does not apply. Commenters also requested exceptions to this requirement for “closed registries,” which the commenter defined as registries not open to a ll eligible professionals for participation. Response: We understand the commenters’ concerns regarding requiring registries to be able to report on all cross-cutting measures specified in Table 52. We made this proposal to allow eligible professionals and group practices the option to report on as many cross-cutting measures as are applicable. However, we understand that it may by overly burdensome for certain registries, such as those registries geared towards sp ecialties for which the cross-cutting measures do not apply or “closed registries.” Therefore, based on the comments received, we are not finalizing our proposal to require that qualified registries be able to report on all cross- cutting measures specified in Table 52 for which the registry’s participating eligible professionals are able to report. We note, however, as we describe in greater detail below, eligible professionals and group practices using the registry-based reporting mechanism that see at least 1 Medicare patient in a face-to-face encounter must still report on 1 crosscutting measure to meet the criteria for satisfactory reporting for the 2017 PQRS payment adjustment. Therefore, in order for the registry’s participating eligible professionals and group practices to meet the criteria for satisfactory reporting for the 2017 PQRS pa yment adjustment, the registry must be able toCMS-1612-FC 657

report to report on at least 1 cross-cutting measure on be half of its participating eligible professionals and group practices. Furthermore, in the CY 2013 PFS final rule, we not ed that qualified registries have until the last Friday of February following the applicable repor ting period (for example, February 28, 2014, for reporting periods ending in 2013) to submit quality measures data on beha lf of its eligible professionals (77 FR 69182). We continue to receive stakeholder feedback, pa rticularly from qualified registries currently participating in the PQRS, urging us to ex tend this submission deadline due to the time it takes for these qualified registries to collect and analyze th e quality measures data received after the end of the reporting period. Although, at the time, we emphasi zed the need to have quality measures data received by CMS no later than the last Friday of the Februa ry occurring after the end of the applicable reporting period, we believe it is now feasible to extend this deadline. Therefore, we proposed to extend the deadline for qualified registries to submit quality meas ures data, including, but not limited to, calculations and results, to March 31 following the end of the ap plicable reporting period (for example, March 31, 2016, for reporting periods ending in 2015). We in vited and received the following public comments on this proposal: Comment: Commenters supported this proposal, as it would allow qualified registries an additional month to submit quality measures data. Response: We appreciate the commenters’ positive feedback. Based on the comments received and for the reasons stated in the proposed rule, we are finalizing our proposal to extend the deadline for qualified registries to submit quality measures data, in cluding, but not limited to, calculations and results, to March 31 following the end of the applicable re porting period (for example, March 31, 2016, for reporting periods ending in 2015). b. Changes to the Requirements for the Direct EHR and EHR Data Submission Vendor Products That

Are CEHRT In the CY 2013 PFS final rule with comment pe riod, we finalized requirements that although EHR vendors and their products would no longer be required to undergo the previously existing qualification process, we would only accept the data if the data are: (1) transmitted in a CMS-approvedCMS-1612-FC 658

XML format utilizing a Clinical Document Architectur e (CDA) standard such as Quality Reporting Data Architecture (QRDA) level 1 (and fo r EHR data submission vendor prod ucts that intend to report for purposes of the proposed PQRS-Medicare EHR Incentiv e Program Pilot, if the aggregate data are transmitted in a CMS-approved XML format); and (2 ) in compliance with a CMS-specified secure method for data submission (77 FR 69183 through 6 9187). To further clarify, EHR vendors and their products must be able to submit data in the form and manner specified by CMS. Accordingly, direct EHRs and EHR data submission vendors must comp ly with CMS Implementation Guides for both the QRDA-I and QRDA-III data file formats. The Im plementation Guides for 2014 are available athttp://www.cms.gov/Regulations-andGuidance/Legislation/EHRIncentivePr ograms/Downloads/Guide_QRDA_2014eCQM.pdf . Updated guides for 2015, when available, will be poste d on the CMS EHR Incentive Program website at http://www.cms.gov/Regulations-and-Guidance/Legislation/EHRIncentivePrograms . These implementation guides further describe the technical re quirements for data submission to ensure the data elements required for measure calculation and verifi cation are provided. We proposed to continue applying these requirements to direct EHR products and EHR data submissi on vendor products for 2015 and beyond. We received no public comment on our proposal to conti nue applying these requirements. Therefore, we are finalizing our proposal to have direct EHRs and EHR data submission vendors comply with CMS Implementation Guides for both the QR DA-I and QRDA-III data file formats for 2015 and beyond. For 2015 and beyond, we also proposed to have the eligible professional or group practice provide the CMS EHR Certification Number of the product used by the eligible professional or group practice for direct EHRs and EHR data submission vendor s. We believe this requirement is necessary to ensure that the eligible professionals and group practices that are using EHR technology are using a product that is certified EHR technology (CEHRT) an d will allow CMS to ensure that the eligible professional or group practice’s data is derived from a product that is CEHRT. We solicited but received no public comment on this proposal. However, we do not believe it is feasible for us to collect thisCMS-1612-FC 659

information at this time, because we do not have a venue in which to store this information. Therefore, we are not finalizing this proposal. c. Changes to the Requirements for the QCDR Reporting Outcome Measures: In accordance with the criterion for satisfactory pa rticipation in a QCDR that we proposed for the 2017 PQRS payment adjustment, we proposed to requ ire a QCDR to possess at least 3 outcome measures (or, in lieu of 3 outcome measures, at least 2 outcome measures and at least 1 of the following other types of measures - resource use, patient experience of care, or efficiency/appropriate use) (79 FR 40393). We solicited and received the following comment on this proposal: Comment: The majority of commenters opposed this proposal. The commenters believed this proposed requirement was overly burdensome, particul arly for the QCDRs that do not have 3 outcome measures available for reporting currently. The commenters urged CMS not to bring about change to a reporting option that is still relatively new. Response: We understand the commenters’ concerns. As we describe in greater detail in section III.K.3.a. below, we are modifying our final criteri on for satisfactory participation in a QCDR for the 2017 PQRS payment adjustment by only requiring th at an eligible professional report on at least 2 outcome measures (or, in lieu of 2 outcome measures, at least 1 outcome measure and 1 of the following other types of measures – resource use, patient experien ce of care, efficiency/appropriate use, or safety). Since this proposal was intended to be consistent w ith our final criterion for the satisfactory participation in a QCDR for the 2017 PQRS payment adjustment, we are modifying this proposal and finalizing the following requirement for QCDRs: a QCDR must po ssess at least 2 outcome measures. If the QCDR does not possess 2 outcome measures, then, in lieu of 2 outcome measures, the QCDR must possess at least 1 outcome measures and 1 of the following ot her types of measures – resource use, patient experience of care, efficiency/appropriate use, or safety. We believe this modification does not significantly change the current QCDR requirement to possess at least 1 outcome measure, as a QCDR may still possess only one measure for reporting in 2 015 and still qualify to become or remain a QCDRCMS-1612-FC 660

provided that the QCDR possesses 1 of the following other types of measures – resource use, patient experience of care, efficiency/appropriate use, or safety. Reporting Non-PQRS Measures: To establish the minimum number of measures (9 measures covering at least 3 NQS domains) a QCDR may report for the PQRS, we placed a limit on the number of non-PQRS measures (20) that a QCDR may submit on behalf of an eligible professiona l at this time (78 FR 7 4476). We proposed to change this limit from 20 measures to 30 (79 FR 40393). We solicited and received the following public comment on this proposal: Comment: Some commenters supported this proposal, as it would allow QCDRs to report on more measures that may cover a broader range of specialties and sub-specialties. A few commenters opposed this proposal, as the commenters urged CMS not to bring about change to a reporting option that is still relatively new. Response: We appreciate the commenters’ positive feedback. While we understand the need to provide continuity and stability in this reporting opti on, particularly during its early stages, we believe that the benefits of allowing QCDRs potentially to cover a broader range of specialties and sub-specialties outweigh the commenters’ concerns. Therefore, we ar e finalizing our proposal that beginning with the criteria for satisfactory participation for the 2017 PQRS payment adjustment, a QCDR may submit quality measures data for a maximum of 30 non-PQRS measures. Please note that this limit does not apply to measures contained in the PQRS measure set, as QCDRs can report on as many measures in the PQRS measure set as they wish. Also, please note th at QCDRs are not required to report on 30 nonPQRS measures. Rather, the reporting of non-PQRS measures is optional, a nd our final rule here increases the number of optional additional m easures that a QCDR may elect to submit. Definition of a Non-PQRS Measure: Additionally, CMS’ experience during the 2014 self-nomination process shed light on clarifications needed on what is considered a non-PQRS measure. Therefore, to clarify the definition of non-PQRS measures, we proposed the following paramete rs for a measure to be considered a non-PQRS

measure:CMS-1612-FC 661

● A measure that is not contained in the PQRS measure set for the applicable reporting period.

● A measure that may be in the PQRS measure set but has substantive differences in the manner it is reported by the QCDR. For example, PQRS measure 319 is reportable only via the GPRO web interface. A QCDR wishes to report this measure on behalf of its eligible professionals. However, as CMS has only extracted the data collected from this quality measure using the GPRO web interface, in which CMS utilizes a claims-based assignment and sam pling methodology to inform the groups on which patients they are to report, the reporting of this measure would require changes to the way that the measure is calculated and reported to CMS via a QC DR instead of through the GPRO web interface. Therefore, due to the substantive changes needed to report this me asure via a QCDR, PQRS measure 319 would be considered a non-PQRS measure. In add ition, CAHPS for PQRS is currently reportable only via a CMS-certified survey vendor. However, although CAHPS for PQRS is technically contained in the PQRS measure set, we consider the changes that will need to be made to be available for reporting by individual eligible professionals (and not as a part of a group practice) significant enough as to treat CAHPS for PQRS as a non-PQRS measure for purposes of reporting CAHPS for PQRS via a QCDR.

To the extent that further clarification on the distinction between a PQRS and a non-PQRS measure is necessary, we will provide additional guidance on our website at http://www.cms.gov/Medicare/Quality-Initiatives-Pa tient-Assessment-Instruments/pqrs/index.html

. Public Reporting of QCDR Quality Measures Data: Furthermore, under our authority to establish the re quirements for an entity to be considered a QCDR under section 1848(m)(3)(E)(i) of the Act, we esta blished certain requirements for an entity to be considered a QCDR in the CY 2014 PFS final rule with comment period (78 FR 74467 through 74473). Under this same authority, we proposed here to add th e following requirement that an entity must meet to serve as a QCDR under the PQRS for reporting periods beginning in 2015:

● Require that the entity make available to th e public the quality measures data for which its eligible professionals report. To clarify this proposal, we proposed that, at a minimum, the QCDR publicly report the following quality measures data information th at we believe will give patient s adequate information on the careCMS-1612-FC 662

provided by an eligible professional: the title and d escription of the measures that a QCDR reports for purposes of the PQRS, as well as the performance resu lts for each measure the QCDR reports. We solicited and received the following public comment on this proposal: Comment: Some commenters supported this proposal, as the commenters believed it was reasonable to require that this information be made available to the public. These commenters supported our proposal to defer to the QCDR in terms of what platform and in what manne r this data may be made available to the public. Some commenters opposed this proposal, stating that the public reporting requirement was overly burdensome, and urged CMS to delay requiring the posting of measures data until the measures have been tested for validity and relia bility. The commenters believed that CMS should not make substantial changes in the QCDR requirement s as the QCDR option is new and the entities need time to familiarize themselves with the QCDR option before new requirements are established. Response: With respect to th e commenters who opposed this proposal and urged CMS not to make additional changes to the QCDR option while en tities become more familiar with this option, we understand the commenters’ concerns. However, we belie ve that transparency of data is a key component of a QCDR option. We believe that it is appropriate to finalize this public reporting requirement at this time. In the CY 2014 PFS final rule, while we did no t finalize our proposal that a QCDR have a plan to publicly report quality measures data, we noted that we encouraged “these qualified clinical data registries to move towards the public reporting of quality measures data” and that we planned to “establish such a requirement in the future” and would “revisit this proposed requirement as part of CY 2015 rulemaking” (78 FR 74471). Therefore, we be lieve that QCDRs were on notice that we would propose and finalize a requirement to make quality measu res data available to the public beginning with the CY 2015 reporting. However, although we do not belie ve we should further delay re quiring public report of QCDR quality measures data, we do agree with the co mmenters on delaying public posting of measures

information until a measure has been tested for validit y and reliability. Therefore, we are providing an exception to this requirement for new measures (both PQRS and non-PQRS measures) that are in their first year of reporting by a QCDR under the PQRS. We define a measure being introduced in the PQRSCMS-1612-FC 663

for the first time as the first time a quality measure is either introduced in the PQRS measure set in rulemaking as a new measure for that reporting period or, for non-PQRS measures that can be reported by a QCDR, the first time a QCDR submits a measure (including its measure specifications) for reporting for the PQRS for the first time. Please note that, to the extent that a QCDR first reports on a non-PQRS measure that is already being reported by another QC DR, we would consider the measure a measure that is in its first year of reporting for that respective QCDR who is reporting the measure for the first time. We believe that providing QCDRs with one year to test and validate new measures provides sufficient time for QCDRs to find potential data issues and correct those issues prior to a measure’s second year of reporting in the PQRS.

Based on the comments received and for the reasons stated in the proposed rule, we are finalizing this proposal to require that the entity make availabl e to the public the quality measures data for which its eligible professionals report. However, as we expl ained above, we are providing an exception to this requirement for new PQRS and non-PQRS measures that are in their first year of reporting by a QCDR under the PQRS. Therefore, quality measure data for a PQRS or non-PQRS measure that is being reported by a QCDR in the PQRS for the first time does not need to be posted for at least the initial year. After the initial year of reporting a new measure, as we believe it is important for a QCDR to be transparent in the quality performance of its eligib le professionals, quality measures performance data for the measure (except for the data coll ected in the measure’s first year of reporting in the PQRS) would be required to be made available to the public. Please note that, in finalizing these requirements on public reporting, we defer to the entity in terms of the method it will use to publicly report th e quality measures data it collects for the PQRS. For example, to meet this requirement, it would be su fficient for a QCDR to publicly report performance rates of eligible professionals through means such as board or specialty websites, or listserv dashboards or announcements. We also note that a QCDR would meet this public reporting requirement if the QCDR’s measures data were posted on Physician Compare. In addition, we defer to the QCDR to determine whether to report performance results at the individual eligible professional level or aggregate the results for certain sets of eligible professionals who are in th e same practice together (but who are not registeredCMS-1612-FC 664

as a group practice for the purposes of PQRS reporting). We believe it is appropriate to allow a QCDR to publicly report performance results at an aggregate le vel for certain eligible professionals when those who are in the same practice contribute to the overall care provided to a patient.

● With respect to when the quality measures data must be publicly reported, we proposed that the QCDR must have the quality measures data by April 31 of the year following the applicable reporting period (that is, April 31, 2016, for reporting period s occurring in 2015). The deadline of April 31 will provide QCDRs with one month to post quality meas ures data and information following the March 31 deadline for the QCDRs to transmit quality measu res data for purposes of the PQRS payment adjustments. Please note that we erroneously stat ed the proposed deadline as April 31, which does not exist in the calendar. We intended to propose a dead line that falls at the end of April—specifically, a deadline of April 30, not April 31, of the year following the applicable reporting period (that is, April 30, 2016, for reporting periods occurring in 2015). This was an inadvertent technical error, and we are therefore correcting this proposal here and our res ponses to comments below to reflect our intention to propose a deadline of April 30 of the year following the applicable reporting period. We believe this does not materially modify this proposal, and as April 31 do es not exist in the calendar, we believe that the public and commenters could reasonably infer that we intended to refer to the end of April in this proposed deadline, which is April 30 and thus reasona bly foresee that we would adopt such a deadline. Therefore, we will address the comments and frame our responses below as they relate to an April 30 deadline of the year following the applicable reporting period (that is, April 30, 2016, for reporting periods occurring in 2015). We also proposed that this data be available on a continuous basis and be continuously updated as the measures undergo chang es in measure title and description, as well as when new performance results are calculated. We solicite d and received the following public comments on this proposal: Comment: A few commenters opposed our proposal to require that a QCDR must have the quality measures data by April 30 of the year following the applicable reporting period. The commenter noted that any performance data publicly posted sh ould be tested for accuracy and reliability. One commenter stated that QCDRs need more time fo llowing the QCDR submission deadline of March 31 toCMS-1612-FC 665

publicly post quality measures data. A nother commenter noted that this timeline is more aggressive than that proposed on Physician Compare. Response: We believe that the proposed April 30 deadline to make available quality measures data (except for PQRS and non-PQRS measures in th eir initial year of reporting under the PQRS) is reasonable, as we assume QCDRs would have alr eady tested quality measures data and results for accuracy and reliability for the particular reporting period prior to submitting these quality measures data calculations and results by the March 31 submission d eadline. However, we agree with the commenter on the need to provide accurate and relia ble data prior to the data being publicly reported. Therefore, given concerns from commenters that April 30 does not provide the QCDRs with enough time to accurately post quality measures data, we are extending the deadline by which a QCDR must publicly report quality measures data outside of Physician Compare to th e deadline by which Physician Compare posts QCDR quality measures data as discussed in section III.J abov e. That is, as indicated in Table 49 in section III.J.3 above, QCDRs wishing to publicly report qua lity measures data outside of Physician Compare

must do so in 2016. Proposals Related to Collaboration of Entities to Become a QCDR: Based on our experience with the qualifying en tities wishing to become QCDRs for reporting periods occurring in 2014, we received feedback from many organizations w ho expressed concern that the entity wishing to become a QCDR may not meet the requirements of a QCDR solely on its own. Therefore, we provided the following proposals beginni ng in 2015 on situations where an entity may not meet the requirements of a QCDR solely on its own bu t, in conjunction with another entity, may be able to meet the requirements of a QCDR and therefore be eligible for qualification:

● We proposed to allow that an entity that u ses an external organization for purposes of data collection, calculation or transmission may meet the definition of a QCDR so long as the entity has a signed, written agreement that specifically details th e relationship and responsibilities of the entity with the external organizations effective as of January 1 th e year prior to the year for which the entity seeks to become a QCDR (for example, January 1, 2014, to be eligible to participate for purposes of data collected in 2015). Entities that have a mere verbal, non-written agreement to work together to become a QCDR byCMS-1612-FC 666

January 1 the year prior to the year for which the entity seeks to become a QCDR would not fulfill this proposed requirement. We solicited and received the following public comment on this proposal: Comment: A few commenters supported this pr oposal, as it allowed entities such as medical boards that may not have the technical capabiliti es to submit quality measures data calculations and

results to CMS to collaborate with other entities. Response: We appreciate the commenters’ supp ort. Based on the comments received, for the reasons stated here, and in the proposed rule, we are finalizing this proposal.

● In addition, we proposed that an entity that has broken off from a larger organization may be considered to be in existence for the purposes of QC DR qualification as of the earliest date the larger organization begins continual existe nce. We received questions from entities who used to be part of a larger organization but have recently become indepe ndent from the larger organization as to whether the entities would meet the requirement established in th e CY 2014 PFS final rule with comment period that the entity be in existence as of January 1 the year pr ior to the year for which the entity seeks to become a QCDR (78 FR 74467). For example, a registry that was previously a part of a larger medical society as of January 1, 2013, could have broken off from the medi cal society and become an independent registry in 2014. Likewise, a member of a medical society could create a registry separate fro m the medical society. As such, there would be concern as to whether that entity would meet the requirement of being in existence prior to January 1, 2013, to be consider ed for qualification for reporting periods occurring in 2014. In these examples, for purposes of meeting the re quirement that the entity be in existence as of January 1 the year prior to the year for which the entity seeks to become a QCDR , we may consider this entity as being in existence as of the date the larger medical society was in existence. We solicited and received the following comments on this proposal: Comment: Commenters supported this proposal. Response: We appreciate the commenters’ supp ort and, based on the comments received and for the reasons stated above, we are finalizing this proposal.

Data Submission Deadline:CMS-1612-FC 667

In the CY 2014 PFS final rule with comment pe riod, in accordance with the submission deadline of quality measures data for qualified registries, we noted a deadline of the last Friday in February occurring after the end of the applicable reporting pe riod to submit quality measures data to CMS (78 FR 74471). In accordance with our proposal to extend th is deadline for qualified registries, we proposed to extend the deadline for QCDRs to submit quality meas ures data calculations and results by March 31 following the end of the applicable reporting period (t hat is, March 31, 2016, fo r reporting periods ending in 2015).

We solicited and received the followi ng public comments on this proposal: Comment: Commenters supported this proposal, as it would allow qualified registries an additional month to submit quality measures data and aligns with our proposal to extend the submission deadline for qualified registries. Response: We appreciate the commenters’ positive feedback. Based on the comments received and for the reasons stated in the proposed rule, we are finalizing our proposal to extend the deadline for QCDRs to submit quality measures data, including, but not limited to, calculations and results, to March 31 following the end of the applicable reporting pe riod (for example, March 31, 2016, for reporting periods ending in 2015). d. Changes to the GPRO Web Interface In the CY 2014 PFS final rule with comment peri od (78 FR 74456), we finalized our proposal to require “that group practices register to participate in the GPRO by September 30 of the year in which the reporting period occurs (that is September 30, 2014 for reporting periods occurring in 2014), as proposed.” However, we noted that, in order “to r espond to the commenters concerns to provide timelier feedback on performance on CG CAHPS in the future , we anticipate proposing an earlier deadline for group practices to register to participate in the GPRO in future years” (78 FR 74456). Indeed, to provide timelier feedback on performance on CAHPS for PQRS, we proposed to modify the deadline that a group practice must register to participate in the GPRO to June 30 of the year in which the reporting period occurs (that is, June 30, 2015, for reporting period s occurring in 2015). Specifically, although we still seek to provide group practices with as much time as f easible to decide whether to register to participateCMS-1612-FC 668

in the PQRS as a GPRO, we weigh this priority with others, such as our desire to provide more timely feedback to participants of the PQRS, as well as ot her CMS quality reporting programs such as the VM. Therefore, in an effort to provide timelier feedback , we proposed to change the deadline by which a group practice must register to participate in the GPRO to June 30 of the applicable 12-month reporting period (that is, June 30, 2015, for reporting periods occurring in 2015). This proposed change would allow us to provide timelier feedback while still providing group practices with over 6 months to determine whether they should participate in the PQRS GPRO or, in the alternative, participate in the PQRS as individual eligible professionals. Although this proposed GPRO registration deadline would provide less time for a group practice to decide whether to participate in th e GPRO, we believe the benefit of providing timelier feedback reports outweighs this concern. We solicited and received the fo llowing public comments on these proposals: Comment: Some commenters supported our proposal to shorten the deadline that a group practice must register to participate in the GPRO to June 30 of the year in which the reporting period occurs (that is, June 30, 2015, for reporting peri ods occurring in 2015) in order to provide timelier feedback reports. Other commenters opposed our propo sal to shorten the deadline from September 30 to June 30, as the commenters believed that the extr a time was needed to weigh the advantages and disadvantages of all the reporting options prior to registering for the GPRO and electing a reporting mechanism. One commenter noted that this is par ticularly important when reporting via EHR, as updates are required for EHR products. Some commenters re quested that information for the various reporting mechanisms, such as the list of qualified registries for the reporting period, be made available earlier.

Other commenters believed that it would be difficu lt for group practices to transition to an earlier registration date and requested that CMS delay finaliz ing this proposal to 2016. Other commenters stated that the proposed deadline would negatively a ffect group practices that change their Taxpayer Identification Number (TIN) after June 30, as the gro up practice would be required to report individually, adding to administrative and reporting burden. Response: With respect to the comments oppos ing this proposal, we believe that June 30 provides group practices with ample time to decide to register to participate in the PQRS as a GPRO, asCMS-1612-FC 669

well as choose a reporting mechanism. With respect to the concern of having to choose a reporting option and not having all information on the PQRS reporting options prior to the June 30 deadline, we note that CMS makes numerous guidance documents available on the CMS website at http://www.cms.gov/Medicare/Quality-Initiatives-Patient -Assessment-Instruments/pqrs/index.html, and group practices can submit any questions to the QualityNet Help Desk at Qnetsupport@hcqis.org

. With respect to some commenters’ requests that in formation for the various reporting mechanisms, such as the list of qualified registries for the reporting period, be made available earlier, we note that the list of qualified registries for 2014 – available at http://www.cms.gov/Medicare/Quality-Initiatives-PatientAssessment-Instruments/PQRS/Down loads/2014QualifiedRegistries.pdf -- was made available in May 2014, prior to June 30, 2014, and we anticipate making the list of qualified registries for the given reporting period available in advance of the proposed June 30 registration deadline. With respect to the commenters who stated that the proposed deadline w ould negatively affect group practices that change their Taxpayer Identification Numbers (TINs) after J une 30, as the group practice would be required to report individually, adding to administrative and reporting burden, we understand this potential burden. We note that this proposed deadline is only 3 mont hs earlier than the September 30 registration deadline we finalized in the CY 2014 PFS final rule (78 FR 74455). Therefore, we believe the issues associated with group practices that change their TINs would be exacerbated by finalizing the proposed June 30 th registration deadline or ameliorated by keeping the current September 30 registration deadline. To the extent that finalizing an earlier deadline would in crease the number of group practices affected by these issues, we believe that our interest in providing feedback sooner outweighs the concern of those group practices that change their TINs after June 30 not be ing able to participate in the GPRO. Based on the reasons stated here and in the proposed rule, we are finalizing our proposal to modify the deadline that a group practice must register to participate in the GP RO to June 30 of the year in which the reporting period occurs (that is, June 30, 2015, for reporting periods occurring in 2015). Please note that this GPRO registration deadline refers to all group practi ces wishing to participate in the GPRO using any reporting mechanism available for reporting in the GP RO (that is, GPRO web interface, registry, EHR, and/or CMS-certified survey vendor).CMS-1612-FC 670

2. Criteria for the Satisfactory Reporting for I ndividual Eligible Professionals for the 2017 PQRS Payment Adjustment Section 1848(a)(8) of the Act, as added by section 3002(b) of the Affordable Care Act, provides that for covered professional services furnished by an eligible professional durin g 2015 or any subsequent year, if the eligible professional does not satisfact orily report data on qua lity measures for covered professional services for the quality reporting period for the year, the fee schedule amount for services furnished by such professional during the year (i ncluding the fee schedule amount for purposes of determining a payment based on such amount) shall be e qual to the applicable percent of the fee schedule amount that would otherwise apply to such services. For 2016 and subsequent years, the applicable percent is 98.0 percent. a. Criterion for the Satisfactory Re porting of Individual Quality Measu res via Claims and Registry for Individual Eligible Professionals for the 2017 PQRS Payment Adjustment In the CY 2014 PFS final rule with comment peri od (see Table 47 at 78 FR 74479), we finalized the following criteria for satisfactory reporting fo r the submission of individual quality measures via claims and registry for the 2014 PQRS incentive: For the 12-month reporting period for the 2014 PQRS incentive, the eligible professional would report at least 9 measures, covering at least 3 of the NQS domains, OR, if less than 9 measures apply to the eligible professional, report 1—8 measures, AND report each measure for at least 50 percent of the Medicare 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 9 measures covering less than 3 NQS domains via the claims- or registry-based reporting mechanism, the el igible professional would be subject to the measure application validity (MAV) process, which would allow us to determine whether the eligible professional should have reported qua lity data codes for additional measures. To be consistent with the satisfactory repor ting criterion we finalized for the 2014 PQRS incentive, for the 2017 PQRS payment adjustment, we proposed to modify §414.90(j) and proposed the following criterion for individual e ligible professionals reporting via claims and registry: For the 12- month reporting period for the 2017 PQRS payment ad justment, the eligible professional would report atCMS-1612-FC 671

least 9 measures, covering at least 3 of the NQS domains AND report each measure for at least 50 percent of the eligible professional’s Medicare Part B FFS patients seen during the reporting period to which the measure applies. Of the measures reported, if the eligible professional sees at least 1 Medicare patient in a face-to-face encounter, as we proposed to define that term below, the eligible professional would report on at least 2 measures contained in the proposed cross-cutting measure set specified in Table 52. If less than 9 measures apply to the eligible professional, the eligible professional would report up to 8 measure(s), AND report each measure for at least 50 percent of the Medicare Part B FFS patients seen during the reporting period to which the measure app lies. Measures with a 0 percent performance rate would not be counted (79 FR 40395). We noted that, unlike the criterion we finalized for the 2014 PQRS incentive, we proposed to require an eligible professional who sees at least 1 Medicare patient in a face-to-face encounter, as we defined that term below, during the 12-month 2017 PQ RS payment adjustment reporting period to report at least 2 measures contained in the cross-cutting measur e set specified in Table 52. As we noted in the CY 2014 PFS proposed rule (78 FR 43359), we are dedi cated to collecting data that provides us with a better picture of the overall quality of care furnished by eligible professionals, particularly for the purpose of having PQRS reporting being used to assess qua lity performance under the VM. We believe that requiring an eligible professional to report on at least 2 broadly applicable, cross-cutting measures will provide us with quality data on more varied aspects of an eligible professional’s practice. We also noted that in its 2014 pre-rulemaking final report (available athttp://www.qualityforum.org/Publications/2014/01/MAP_PreRulemaking_Report__2014_Recommendations_on_Measu res_for_More_than_20_Federal_Programs.asp

x ), the Measure Applications Partnership (MAP) encour aged the development of a core measure set (see page 16 of the “MAP Pre-Rulemaking Report: 201 4 Recommendations on Measures for More than 20 Federal Programs”). The MAP stated, “a core [mea sure set] would address critical improvement gaps, align payment incentives across clinician types, and reduce reporting burden.” For what defines a “face-to-face” encounter, for purposes of reporting of at least 2 cross-cutting measures specified in Table 52, we proposed to dete rmine whether an eligible professional had a “face-to-CMS-1612-FC 672

face” encounter by seeing whether the eligible pr ofessional billed for services under the PFS that are

associated with face-to-face encounter s, such as whether an eligible professional billed general office visit codes, outpatient visits, and surgical procedures. We would not include telehealth visits as face-to-face encounters for purposes of the required reporting of at least 2 cross-cutting measures specified in Table 52 (79 FR 40395 and40396). In addition, we understand that there may be instances where an eligible professional may not have at least 9 measures applicable to an eligible professional’s practice. In this instance, like the criterion we finalized for the 2014 PQRS incentiv e (see Table 47 at 78 FR 74479), an eligible professional reporting on less than 9 measures would s till be able to meet the satisfactory reporting criterion via claims and registry if the eligible prof essional reports on 1-8 measures, as applicable, to the eligible professional’s practice. If an eligible professional reports on 1-8 measures, the eligible professional would be subject to the MAV process, which would allow us to determine whether an eligible professional should have re ported quality data codes for additional measures. In addition, the MAV will also allow us to determine whether a gr oup practice should have reported on any of the crosscutting measures specified in Table 52. The MAV pr ocess we proposed (79 FR 40396) to implement for claims and registry is the same process that was established for reporting periods occurring in 2014 for the 2014 PQRS incentive. We solicited public comment on our satisfactory reporting criterion for individual eligible professionals reporting via claims or registry for th e 2017 PQRS payment adjustment. The following is a summary of the comments we received regarding our proposal for satisfactory reporting criterion for individual eligible professionals reporting via claims or registry for the 2017 PQRS payment adjustment.Comment: A few commenters supported our intention to move towards eliminating the claimsbased reporting option, while the majority of the commenters opposed our proposals related to moving away from the claims-based reporting option. Some of these commenters noted that, for certain eligible professionals, the claims-based reporting mechanism remains the only optio n by which eligible professionals may report PQRS quality measures data, as many eligible professionals do not have the capabilities to report via EHR or registry. The comme nters believe the claim-based reporting mechanismCMS-1612-FC 673

is a necessary option for eligible professionals with li mited resources, such as solo practitioners. Shouldwe intend to phase out this reporting mechanism, commenters urged a gradual phase out of the claimsbased reporting mechanism. Response: We appreciate the commenters' fee dback. We understand the concerns associated with moving away from the claims-based reporting m echanism. For the 2017 PQRS payment adjustment, we are finalizing an option by which eligible professi onals may meet the criteria for satisfactory reporting by using the claims-based reporting mechanism. Eligible professionals using the other reporting mechanisms have seen greater success at meeting the criteria for satisfactory reporting for the PQRS. However, while we continue to eliminate measures available for reporting via claims, we understand the importance of maintaining the claims-based reporti ng mechanism as an option at this time. We understand that the claims-based reporting mechanism remains the most popular reporting mechanism. However, to streamline the PQRS reporting options , as well as to encourage reporting options where eligible professionals are found to be more successful in reporting, it is our in tention to eliminate the claims-based reporting mechanism in future rulemaki ng. During this time, we encourage eligible professionals to use alternative reporting methods to become familiar with reporting mechanisms other than the claims-based reporting mechanism. Comment: The majority of commenters opposed our proposal to require the reporting of 9 measures to meet the criteria for satisfactory reportin g for the 2017 PQRS payment adjustment. Some of these commenters noted that eligible professionals ha ve been successful at meeting the criteria for satisfactory reporting for the PQRS incentives and pa yment adjustments in the past by reporting 3 measures, and increasing the number of measures to be reported would make it more difficult for these eligible professionals to meet the criteria fo r satisfactory reporting for the 2017 PQRS payment adjustment. Other commenters also noted that cer tain eligible professionals do not have 9 measures covering 3 NQS domains to report. For these reas ons, some commenters suggested a more gradual approach to requiring the reporting of at least 9 measures covering 3 NQS domains, such as requiring the reporting of 5 or 6 measures rather than 9 measure s. A few commenters also recommended establishing aCMS-1612-FC 674

lower reporting threshold for those eligible professi onals practicing in specialties for which few PQRS

measures exist. Response: While we understand the commenters con cerns related to requiring the reporting of 9 measures covering up to 3 NQS domains, we believe we provided the public with adequate time to prepare for reporting criteria that requires the reporting of 9 measures. For example, we finalized criteria for the satisfactory reporting for the 2016 PQRS paym ent adjustment via claims and registry that only required the reporting of 3 measures covering 1 NQS dom ain (see Table 48 at 78 FR 74480). However, we also finalized criteria for the 2016 PQRS paymen t adjustment using the claims- and registry-based reporting mechanisms that aligned with the followi ng criteria we finalized for the 2014 PQRS incentive: Report at least 9 measures covering at least 3 NQS domains, OR, if less than 9 measures covering at least 3 NQS domains apply to the eligib le professional, report 1-9 measures covering 1-3 NQS domains, AND report each measure for at least 50 percent of the Medicare Part B FFS patients seen during the reporting period to which the measures applies (see Table 48 at 78 FR 74480). Additionally, in the CY 2014 PFS final rule, we noted that "it is our intent to ramp up the criteria for satisfactory reporting for the 2017 PQRS payment adjustment to be on par or more stri ngent than the criteria for satisfactory reporting for the 2014 PQRS incentive" (78 FR 74465). We belie ve that establishing criteria for the satisfactory reporting of the 2016 PQRS payment adjustment that are consistent with these proposed criteria, as well as signaling our intent to ramp up the satisfactory re porting criteria, provided enough advance notice to encourage eligible professionals to prepare to repor t 9 measures to meet the criteria for satisfactory reporting for the 2017 PQRS payment adjustment. Furthermore, with respect to those commenters c oncerned that an eligible professional may not have 9 measures covering at least 3 NQS domains appli cable to his/her practice, in the proposed rule we noted that in this instance, like the criterion we fina lized for the 2014 PQRS in centive (see Table 47 at 78 FR 74479), an eligible professional reporting on less than 9 measures would still be able to meet the satisfactory reporting criterion via claims and registry if the eligible professional reports on 1–8 measures, as applicable, to the eligible professional’s practice. If an eligible professional reports on 1–8 measures, the eligible professional would be subject to the MAV process, whic h would allow us to determineCMS-1612-FC 675

whether an eligible professional should have reporte d quality data codes for additional measures. In addition, the MAV process will also allow us to de termine whether a group practice should have reported on any of the cross-cutting measures specified in Tabl e 52. As such, under this proposed criteria for satisfactory reporting for the 2017 PQRS payment adjust ment, an eligible professional who does not have at least 9 measures covering at least 3 NQS domains applicable to his/her practice may still meet the criteria for satisfactory reporting for the 2017 PQRS payment adjustment provided that the eligible professional reports all measures as are applicable to his/her practice.

Based on the comments received and for the reasons stated above and in the proposed rule, we are finalizing our proposal to require th e reporting of 9 measures covering at least 3 NQS domains to meet the criteria for satisfactory reporting for the 2017 PQRS payment adjustment. In the case that an eligible professional may not have at least 9 measures applicable to an eligible professional’s practice, the eligible professional may still be able to meet the satisfactory reporting criterion via claims and/or registry for the 2017 PQRS payment adjustment if the eligible professional reports on 1–8 measures. The eligible professional would be required to report as many measures as are applicable to the eligible professional’s practice. If reporting less than 9 measures covering 3 NQS domains, the eligible professional would be subject to the MAV process, which would allow us to determine whether an eligible professional should have reported quality da ta codes for additional

measures. Comment: Some commenters provided general s upport for the option to report cross-cutting measures, as it may help bring alignment with respect to a set of measures all eligible professionals may report. However, most of these commenters believe d that the reporting of cross-cutting measures should be voluntary, not mandatory. The majority of comme nters opposed our proposal to require an eligible professional who sees at least 1 Medicare patient in a face-to-face encounter during the 12-month 2017 PQRS payment adjustment reporting period to report atleast 2 measures contained in the proposed crosscutting measure set specified in Table 52 (78 FR 40395). Some of these commenters believed that the proposed requirement is unfair, as the requirement to report on at least 2 cross-cutting measures placed an additional burden on certain specialists, such as tho se that do not provide primary care services, and notCMS-1612-FC 676

on others. Other commenters emphasized that the cro ss-cutting measures did not apply to many specialty practices. Contrary to these commenters, some commen ters expressed support for this proposal. Some of those who supported, this proposal, however, recomm ended a more phased-in approach to the reporting of cross-cutting measures. One of these commenter s recommended that the proposal be amended to require only the reporting of 1 measure in the cross- cutting measure set. Some of these commenters were confused as to whether this proposal would increase the proposed number of measures to be reported to

11 measures. Response: With respect to the commenters’ concerns that requiring reporting of at least 2 crosscutting measures for eligible professionals who see at l east 1 Medicare patient in a face-to-face encounter, we understand that the cross-cutting measures we are finalizing in Table 52 are limited and should only apply to certain eligible professiona ls for which the measures apply. We believe we sufficiently exclude eligible professionals for which the cross-cutti ng measures do not apply by only proposing this requirement for eligible professionals who see at least 1 Medicare patient in a face-to-face encounter. We believe our interest in collecting data that are more varied to better capture the overall quality of care provided to patients as well as our desire to create a core set of measures for PQRS outweighs this concern. In the future, we will consider adding to this cross-cutting measures set so that more professionals that are eligible may be able to particip ate in the reporting of a core set of measures. With respect to the commenters who expressed concern thatthe proposed measures in the proposed crosscutting measures set did not apply to many specialties, we note that an eligible professional would not be required to report on the measures contained in th e cross-cutting measures set if none of the measures applied to the eligible professional’s practice. W ith respect to taking a more phased-in approach to introducing the cross-cutting measure set, for the 20 17 PQRS payment adjustment, we agree with these commenters and will therefore phase-in the require ment to report on cross-cutting measures by only requiring the reporting of 1 cross-cutting measure. We do note, however, that we believe that requiring the reporting of 2 measures in the cross-cutting measures set is not overly burdensome. Rather, we believe it helps eligible professiona ls narrow the choices of measures for which to report in the PQRS measure set. Regardless, we understand the commenters’ concerns regarding the need for a gradual phaseCMS-1612-FC 677

in of the cross-cutting measure set. Therefore, based on the comments received and for the reasons stated above and in the proposed rule, we are modifying our proposal to require that an eligible professional who sees at least 1 Medicare patient in a face-to-face encounter during the 12-month 2017 PQRS payment adjustment reporting period report at least 1 measure contained in the cross-cutting measure set we are finalizing specified in Table 52. Please note that it is our intention to move towards requiring the reporting of more cross-cutting measures in the future. Please also note that this does not bring the total number of measures required to be reported under this criterion to 10 measures. Rather, if an eligible professional sees at least 1 Medicare patient in a face-to-face encounter during the 12-month PQRS pa yment adjustment reporting period, 1 of the 9 measures the eligible professional reports must be measures contained in the cross-cutting measure set. Therefore, an eligible professional would report at least 1 cross-cutting measure and 8 additional PQRS measures covering 3 NQS domains. In the instance where an eligible professional ma y not have at least 9 measures applicable to his/her practice, the eligible professional would still be required to report at least 1 cross-cutting measure, if applicable. As we noted, we believe we sufficien tly exclude eligible professionals for which the crosscutting measures do not apply by only proposing this requirement for eligible professionals who see at least 1 Medicare patient in a face-to-face encounter.

Comment: One commenter believes that the thr eshold of seeing 1 Medicare patient in a face-toface encounter for the requirement to report on cro ss-cutting measures is too low. The commenter was concerned that this would further burden eligib le professionals who rarely see Medicare patients. Response: We understand the commenter’s concern. However, as we believe in the importance of the cross-cutting measures set we are finalizing in Table 52, it is our desire to encourage reporting of the measures contained in the cross-cutting measures set when applicable. We proposed this threshold to exclude certain specialties that do not see Medicare pa tients. However, we expect those eligible professionals who see Medicare patients to report on the cross-cutting measures we specify in Table 52.CMS-1612-FC 678

Comment: One commenter sought clarification on the definition of a face-to-face encounter by specifying which codes apply to this definition and ur ged that procedural encounters not be included in

the list of face-to-face encounters. Response: As we stated in the proposed rule, we will determine whether an eligible professional had a ‘‘face-to-face’’ encounter by seeing whether the eligible professional billed for services under the PFS that are associated with face-to-face encounters, such as whether an eligible professional billed general office visit codes, outpatient visits, and su rgical procedures. We would not include telehealth visits as face-to-face encounters for purposes of the re quirements to report at least 1 cross-cutting measure specified in Table 52 (79 FR 40395 through 40396). While we will not provide the specific codes for what we define as a “face-to-face” encounter here, we will provide the codes and any additional guidance on the PQRS website at http://www.cms.gov/Medicare/Quality-Initiatives-Patient-AssessmentInstruments/PQRS/index.html

. Comment: Some commenters opposed our proposal to require that, to meet the criteria for satisfactory reporting for the 2017 PQRS payment adjustment, an eligible professional reporting individual measures via claims or registry report each measure for at least 50 percent of the eligible professional’s Medicare Part B FFS patients seen duri ng the reporting period to which the measure applies. The commenters noted that, particularly fo r those eligible professionals who see many patients, requiring the reporting of quality measures for more than 50 percent of the eligible professional’s Medicare Part B FFS patients is burdensome. Response: We understand this c oncern, particularly with those eligible professionals who see a large number of patients. However, it is important to collect sufficient quality measures data to ensure an adequate sample. We believe that the 50 percent threshold provides us with an adequate sample to properly determine the quality of care provided. We also believe that requiring that an eligible professional report on at least 50 percent of his/her Medicare Part B FFS patients helps to prevent potential selection bias that could skew the represen tation of quality of care; while the potential for selection bias still remains, we were mindful of con cerns about provider burden during this period where eligible professionals are still becoming accustomed to PQRS reporting. Based on the comments receivedCMS-1612-FC 679

and for the reasons stated above and in the proposed ru le, we are finalizing our proposal to require that, to meet the criteria for satisfactory reporting for the 2017 PQRS payment ad justment, an eligible professional reporting individual measures via claims or registry report each measure for at least 50 percent of the eligible professional’s Medicare Pa rt B FFS patients seen during the reporting period to which the measure applies. Comment: Some commenters generally suppor ted the MAV process. However, some commenters expressed the need to clarify the MAV process for both claims and registry as well as to provide greater transparency in this process. Response: We understand the need to further clarify the MAV process for both claims and registry, as well as to provide transparency in this process. We believe the 2015 MAV process that we proposed for the 2017 PQRS payment adjustment is transparent, as it is very similar to the 2014 MAV process that we finalized for the 2014 PQRS incentiv e and 2016 PQRS payment adjustment, for which we have already provided detailed technical guidance. Specifically, we have made education and outreach documents, as well as the MAV measure clusters, (that is, sets of measures that determine when other measures could have been reported and therefore tri gger use of the MAV process), available for the 2014 MAV process at http://www.cms.gov/Medicare/Quality-Initiatives-Patient-AssessmentInstruments/PQRS/AnalysisAndPayment.html , and we will update these materials as necessary for the 2015 MAV process. Please note that, as the MAV pro cess evolves, we expect to be able to provide further guidance to aid eligible professionals in un derstanding the MAV process. We will post additional clarifying information, including a document expl aining the MAV process for 2015, on the PQRS website

at http://www.cms.gov/Medicare/Quality-Initiatives-Patie nt-Assessment-Instruments/pqrs/index.html

. We believe that posting this guidance as we have in years prior provides adequate transparency in this process. Moreover, should an eligible professional ha ve further questions regarding the MAV process, he or she may contact our QualityNet Help Desk for more information. The contact information for the Help

Desk can be found here: http://www.cms.gov/Medicare/Quality-Initiatives-Patient-AssessmentInstruments/PQRS/HelpDeskSupport.html

.CMS-1612-FC 680

After reviewing the comments, we are finalizing our proposal to modify §414.90(j) and finalize the following criterion for individual eligible professionals reporting via claims and registry: For the 12-month reporting period for the 2017 PQRS payment adjustment, report at least 9 measures, covering at least 3 of the NQS domains AND report each measure for at least 50 percent of the eligible professional’s Medicare Part B FFS patie nts seen during the reporting period to which the measure applies. Of the measures reported, if the eligible professional sees at least 1 Medicare patient in a face-to-face encounter, the eligible professional w ill report on at least 1 measure contained in the proposed cross-cutting measure set specified in Table 52. If less than 9 measures apply to the eligible professional, the eligible professiona l would report up to 8 measure(s), AND report each measure for at least 50 percent of the Medicare Part B FFS patients seen during the reporting period to which the measure applies. Measures with a 0 percen t performance rate would not be counted. We understand that there may be instances where an eligible professional may not have at least 9 measures applicable to an eligible professional’s pr actice. In this instance, an eligible professional reporting on less than 9 measures would still be able to meet the satisfactory reporting criterion via claims and registry if the eligible professional reports on 1-8 measures, as applicable, to the eligible professional’s practice. If an eligible professional reports on 1-8 measures, the eligible professional would be subject to the MAV process, which woul d allow us to determine whether an eligible professional should have reported qua lity data codes for additional me asures. In addition, the MAV process will also allow us to determine whether a gr oup practice should have reported on any of the crosscutting measures specified in Table 52. The MAV pro cess we will implement for claims and registry for the 2017 PQRS payment adjustment is the same process that was established for reporting periods occurring in 2014 for the 2014 PQRS incentive. Fo r more information on the claims MAV process, please visit http://www.cms.gov/Medicare/Quality-Initiatives-Patient-AssessmentInstruments/PQRS/Downloads/2014_PQRS_Clai ms_MeasureApplicabilityValidation_12132013.zip . For more information on the registry MAV process, please visit http://www.cms.gov/Medicare/QualityInitiatives-Patient-AssessmentInstruments/PQRS/Downloads/2014_PQRS_Regist ry_MeasureApplicabilityValidation_12132013.zip

.CMS-1612-FC 681

b. Criterion for Satisfactory Reporting of Individua l Quality Measures via EHR for Individual Eligible Professionals for the 2017 PQRS Payment Adjustment In the CY 2013 PFS final rule with comment peri od, we finalized the following criterion for the satisfactory reporting for individual eligible professi onals reporting individual measures via a direct EHR product that is CEHRT or an EHR data submission vendor product that is CEHRT for the 2014 PQRS incentive: Report 9 measures covering at least 3 of the NQS domains. If an eligible professional's CEHRT does not contain patient data for at least 9 measu res covering at least 3 domains, then the eligible professional must report all of the measures for whic h there is Medicare patient data. An eligible professional must report on at least 1 measure for which there is Medicare patient data (see Table 47 at 78 FR 74479).

To be consistent with the criterion we fina lized for the 2014 PQRS incentive, as well as to continue to align with the final criterion for mee ting the clinical quality measure (CQM) component of achieving meaningful use under the Medicare EHR Incen tive Program, we proposed to modify §414.90(j) and proposed the following criterion for the satisfactor y reporting for individual eligible professionals to report individual measures via a direct EHR product th at is CEHRT or an EHR data submission vendor product that is CEHRT for the 2017 PQRS payment adju stment: The eligible professional would report 9 measures covering at least 3 of the NQS domains. If an eligible professional’s CEHRT does not contain patient data for at least 9 measures covering at least 3 domains, then the eligible professional would be required to report all of the measures for which there is Medicare patient data. An eligible professional would be required to report on at least 1 meas ure for which there is Medicare patient data. We solicited public comment on this proposal. The following is summary of the comments we received regarding our proposed criterion for the satisfactory reporting for individual eligible professi onals to report individual measures via a direct EHR product that is CEHRT or an EHR data submission vendor product that is CEHRT for the 2017 PQRS payment adjustment. Comment: The majority of commenters opposed our proposal to require the reporting of 9 measures to meet the criteria for satisfactory re porting for the 2017 PQRS payment adjustment.CMS-1612-FC 682

Commenters also noted that certain eligible pr ofessionals do not have 9 measures covering 3 NQS domains to report. For these reasons, some commenter s suggested a more gradual approach to requiring the reporting of at least 9 measures covering 3 NQS domains, such as requiring the reporting of 5 or 6 measures rather than 9 measures. A few commenters also recommended establishing a lower reporting threshold for those eligible professionals practicing in specialties for which few PQRS measures exist. Response: We understand the commenters’ c oncerns. We note that we addressed these comments related to the reporting of 9 measures cove ring 3 domains as it relates to reporting via claims and registry above in section III.K.1.a., and that explan ation also applies here with reporting via a direct EHR product that is CEHRT or EHR data submission ve ndor product that is CEHRT. Furthermore, we believe that aligning our EHR reporting options w ith the CQM component of meaningful use under the EHR Incentive Program actually reduces burden on el igible professionals when reporting. For the reasons explained above and to be co nsistent with the criterion we are finalizing for claims and registry as well as to be consistent with the requirements to meet the CQM component of meaningful use under the EHR Incentive Program, we are finalizing this proposal. After reviewing the comments, we are finalizing our proposal as proposed to modify §414.90(j) and to indicate the following criterion for the satisfactor y reporting for individual eligible professionals to report individual measures via a direct EHR product th at is CEHRT or an EHR data submission vendor product that is CEHRT for the 2017 PQRS payment adjustment: For the 12-month reporting period for the 2017 PQRS payment adjustment, report 9 measures covering at least 3 of the NQS domains. If an eligible professional’s CEHRT does not contain patien t data for at least 9 measures covering at least 3 domains, then the eligible professional would be requir ed to report all of the measures for which there is Medicare patient data. An eligible professional woul d be required to report on at least 1 measure for which there is Medicare patient data. c. Criterion for Satisfactory Reporting of Measur es Groups via Registry for Individual Eligible Professionals for the 2017 PQRS Payment Adjustment In the CY 2013 PFS final rule with comment peri od, we finalized the following criterion for the satisfactory reporting for individual eligible professi onals to report measures groups via registry for theCMS-1612-FC 683

2014 PQRS incentive: For the 12-month reporting peri od for the 2014 PQRS incentive, report at least 1 measures group AND report each measures group for at least 20 patients, the majority (11 patients) of which must be Medicare Part B FFS patients. Measures groups containing a measure with a 0 percent performance rate will not be counted (see Table 47 at 78 FR 74479).

To be consistent with the criterion we finali zed for the 2014 PQRS incentive, we proposed to modify §414.90(j) to indicate the following criterion fo r the satisfactory reporting for individual eligible professionals to report measures groups via registry fo r the 2017 PQRS payment adjustment: For the 12- month reporting period for the 2017 PQRS payment ad justment, the eligible professional would report at least 1 measures group AND report each measures group for at least 20 patients, the majority (11 patients) of which would be required to be Medicare Part B FFS patients. Measures groups containing a measure with a 0 percent performance rate would not be counted. Although we proposed a satisfactory reporting crite rion for individual eligible professionals to report measures groups via registry for the 2017 PQRS payment adjustment that is consistent with criterion finalized for the 2014 PQRS incentive, please note that in section III.K of this final rule with comment period, we are changing the definition of a PQRS measures group. We solicited but received no public comment on our proposed satisfactory reporting criterion for individual eligible professionals reporting measures groups via registry for the 2017 PQRS payment adjustment. Therefore, we are finalizing our propo sal as proposed to modify §414.90(j) to indicate the following criterion for the satisfactory reporting for individual eligible professionals to report measures groups via registry for the 2017 PQRS payment adjustment: For the 12-month reporting period for the 2017 PQRS payment adjustment, report at least 1 measures group AND report each measures group for at least 20 patients, the majority (11 patients) of wh ich are required to be Medicare Part B FFS patients. Measures groups containing a measure with a 0 pe rcent performance rate will not be counted. 3. Satisfactory Participation in a QCDR by Individual Eligible Professionals Section 601(b) of the ATRA amended section 1848(m)(3) of the Act, by redesignating subparagraph (D) as subparagraph (F) and adding new subparagraphs (D) and (E), to provide for a newCMS-1612-FC 684

standard for individual eligible pr ofessionals to satisfy the PQRS beginni ng in 2014, based on satisfactory participation in a QCDR. a. Criterion for the Satisfactory Participation for Individual Eligible Professionals in a QCDR for the 2017 PQRS Payment Adjustment Section 1848(a)(8) of the Act provides that fo r covered professional services furnished by an eligible professional during 2015 or any subsequent year, if the eligible professional does not satisfactorily report data on quality measures for covered professional services for the quality reporting period for the year, the fee schedule amount for servi ces furnished by such professional during the year shall be equal to the applicable percent of the f ee schedule amount that would otherwise apply to such services. For 2016 and subsequent years, the applicable percent is 98.0 percent. Section 1848(m)(3)(D) of the Act, as added by section 601(b) of the ATRA, authorizes the Secretary to treat an individual eligible professi onal as satisfactorily submitting data on quality measures under section 1848(m)(3)(A) of the Act if, in lieu of reporting measures under section 1848(k)(2)(C) of the Act, the eligible professional is satisfactorily pa rticipating in a QCDR for the year. “Satisfactory participation” is a new standard under the PQRS a nd is a substitute for the underlying standard of “satisfactory reporting” data on covered professional ser vices that eligible professionals must meet to avoid the PQRS payment adjustment. Currently , §414.90(e)(2) states that individual eligible professionals must be treated as satisfactorily reporting data on quality measures if the individual eligible professional satisfactorily participates in a QCDR.

In the CY 2014 PFS final rule with comment period, although we finalized satisfactory participation criteria for the 2016 PQRS payment adjustme nt that are less stringent than the satisfactory participation criteria we finalized for the 2014 PQRS in centive, we noted that it was “our intention to fully move towards the reporting of 9 measures cove ring at least 3 domains to meet the criteria for satisfactory participation for the 2017 PQRS paymen t adjustment” (78 FR 74477). Specifically, we finalized the following two criteria for the satisfactory participation in a QCDR for the 2014 PQRS incentive at §414.90(i)(3): For the 12-month 2014 reporting period, report at least 9 measures available for reporting under the QCDR covering at least 3 of the NQS domains, and report each measure for atCMS-1612-FC 685

least 50 percent of the eligible professional’s applicab le patients. Of the measures reported via a QCDR, the eligible professional must repor t on at least 1 outcome measure.

To be consistent with the number of measures reported for the satisfactory participation criterion we finalized for the 2014 PQRS incentive, for purpo ses of the 2017 PQRS payment adjustment (which would be based on data reported du ring the 12-month period that falls in CY 2015), we proposed to modify §414.90(k) to add the following criteria for individual eligible professionals to satisfactorily participate in a QCDR for the 2017 PQRS payment adjustment: For the 12-month reporting period for the 2017 PQRS payment adjustment, the eligible pr ofessional would report at least 9 measures available for reporting under a QCDR covering at least 3 of the NQS domains, AND report each measure for at least 50 percent of the eligible professional’s patients. Of these measures, the eligible professional would report on at least 3 outcome measures, OR, if 3 outcomes measures are not available, report on at least 2 outcome measures and at least 1 of the following type s of measures – resource use, patient experience of care, or efficiency/appropriate use. Unlike the satisfactory participation criteria that were established for the 2014 PQRS incentive, we proposed to modify §414.90(k)(4) to require that an eligible professional report on not only 1 but at least 3 outcome measures (or, 2 outcome measures and at least 1 resource use, patient experience of care, or efficiency/appropriate use if 3 outcomes measures are not available). We proposed this increase because it is our goal to, when appropriate, move towa rds the reporting of more outcome measures. We believe the reporting of outcome measures (for example, unplanned hospital readmission after a procedure) better captures the quality of care an elig ible professional provides than, for example, process measures (for example, whether a Hemoglobin A1c t est was performed for diabetic patients). In establishing this proposal, we understood that a QC DR may not have 3 outcomes measures within its quality measure data set. Therefore, as an alternativ e to a third outcome measure, we proposed to allow an eligible professional to report on at least 1 resource use, patient experience of care, or efficiency/appropriate use measure in lieu of an outcome measure. We solicited public comment on these proposals. The following is summary of the comments we received regarding on these proposals.CMS-1612-FC 686

Comment: Commenters generally urged more flexibility in allowing QCDRs to determine reporting criteria under this option. Response: While we agree that QCDRs shoul d generally be given some flexibility when participating in the PQRS, we do not agree that QCDRs be given flexibility in determining reporting criteria. We believe it is necessary to have consiste nt reporting criteria, so that quality measures data on eligible professionals may be more easily compared for purposes of other programs that use PQRS quality data to rate and compare eligible professionals, such as the VM. Comment: The majority of commenters opposed our proposal to require the reporting of 9 measures to meet the criteria for satisfactory re porting for the 2017 PQRS payment adjustment. Commenters also noted that certain eligible pr ofessionals do not have 9 measures covering 3 NQS domains to report. For these reasons, some commenter s suggested a more gradual approach to requiring the reporting of at least 9 measures covering 3 NQS domains, such as requiring the reporting of 5 or 6

measures rather than 9 measures. Response: While we understand the commenters’ c oncerns related to requiring the reporting of 9 measures covering up to 3 NQS domains, we believe we provided the public with adequate time to prepare to reporting criteria that requires the reporting of 9 measures. For example, we finalized criteria for satisfactory participation for the 2016 PQRS paym ent adjustment via a QCDR that aligned with the criteria we finalized for the 2014 PQRS incentive: For the 12-month 2016 PQRS payment adjustment reporting period, report at least 9 measures coveri ng at least 3 NQS domains AND report each measure for at least 50 percent of the applicable patients seen during the reporting period to which the measure applies. Measures with a 0 percent performance rate would not be counted. Of the measures reported via a QCDR, the eligible professional must report on at least 1 outcome measure (78 FR 74478). Additionally, in the CY 2014 PFS final rule, we noted that "it is our intent to ramp up the criteria for satisfactory reporting for the 2017 PQRS payment adjustment to be on par or more stringent than the criteria for satisfactory reporting for the 2014 PQ RS incentive" (78 FR 74465). We believe that establishing criteria for the satisfactory reporting of the 2017 PQRS payment adjustment that are consistent with these proposed criteria as well as signa ling our intent to ramp up the satisfactory reportingCMS-1612-FC 687

criteria provided enough advance notice to encourag e eligible professionals to prepare to report 9 measures to meet the criteria for satisfactory repor ting for the 2017 PQRS payment adjustment. Based on the comments received and for the reasons stated, we ar e finalizing our proposal for QCDRs to require the reporting of 9 measures to meet the criteria for satisfactory reporting for the 2017 PQRS payment adjustment. Comment: Some commenters opposed our proposal to require that, to meet the criteria for satisfactory reporting for the 2017 PQRS payment adjustment, an eligible professional reporting individual measures via a QCDR report each measure for at least 50 percent of the eligible professional’s patients seen during the reporting period to which th e measure applies. The commenters noted that, particularly for those eligible professionals who see many patients, requiring the reporting of quality measures for more than 50 percent of the eligible professional’s patients is an enormous burden. Response: We understand this con cern, particularly with respect to those eligible professionals who see a large number of patients. However, it is im portant to collect sufficient quality measures data to ensure an adequate sample. We also believe that re quiring that an eligible professional report on at least 50 percent of his/her Medicare Part B FFS patients helps to prevent potential selection bias that could skew the representation of quality of care; while th e potential for selection bias still remains, we were mindful of concerns about provider burden during this period where eligible professionals are still becoming accustomed to PQRS reporting. Based on th e comments received and for the reasons stated above and in the proposed rule, we are finalizing our proposal to require that, to meet the criteria for satisfactory participation for the 2017 PQRS paym ent adjustment, an eligible professional reporting individual measures via a QCDR report each measure for at least 50 percent of the eligible professional’s patients seen during the reporting period to which the me asure applies. Please note that, unlike the claims and registry-based reporting mechanisms, if using a QCDR, an eligible professional must report on ALL (Medicare and non-Medicare) patients. Comment: The majority of commenters opposed our proposal to report on at least 3 outcome measures, as many of these commenters believed QCDR s might not have 3 outcome measures availableCMS-1612-FC 688

to report. The commenters urged a more gradual approach to the reporting of outcome measures via a QCDR. Response: We understand the commenters’ con cerns. To accommodate these concerns, we are modifying this proposal to require only reporting of 2 outcome measures or, if 2 outcome measures are not available, report on 1 outcome measure and 1 of the following types of measures – resource use, patient experience of care, efficiency/appropriate use or patient safety. We believe this compromise still raises the bar on the types of measures eligible professionals must report, but allows QCDRs that may only have 1 outcome measure available to still qualify and participate in the PQRS. We note, however,

our intention to increase the number of outcome me asures that must be reported in the future. In addition, we note that we are adding another category – patient safety – of measures that an eligible professional may report in lieu of an outcome measure. While we did not include this category before, we believe the addition of the patient safety cat egory is appropriate, as we believe that it is equally important to measure patient safety, as it is to measure resource use, patient experience of care, or appropriate use. Furthermore, we believe the a ddition of another category of measures that may be reported in lieu of an outcome measure benefits e ligible professionals and QCDRs and is responsive to

some of the commenters’ concerns regarding having enough measures to report, as it provides more options in terms of the measures an eligible professi onal may report in lieu of an outcome measure. We define the term “patient safety” as it applies to QC DRs in the QCDR measure section in III.K.6 below. As a result of the comments, we are revising our proposal to modify §414.90(k) to indicate the following criterion for satisfactory participation in a QCDR for the 2017 PQRS payment adjustment: For the 12-month reporting period for the 2017 PQRS payment adjustment, report at least 9 measures available for reporting under a QCDR covering at least 3 of the NQS domains, AND report each measure for at least 50 percent of the eligible professional’s patients. Of these measures, the eligible professional would report on at least 2 outcome measures, OR, if 2 outcomes measures are not available, report on at

least 1 outcome measures and at least 1 of the fo llowing types of measures – resource use, patient experience of care, efficiency/appropriate use, or patient safety.CMS-1612-FC 689

4. Criteria for Satisfactory Reporting for Group Practi ces Selected to Participate in the Group Practice Reporting Option (GPRO) In lieu of reporting measures under section 1848(k)(2)(C) of the Act, section 1848(m)(3)(C) of the Act provides the Secretary with the authority to establish and have in place a process under which eligible professionals in a group practice (as defined by the Secretary) shall be treated as satisfactorily submitting data on quality meas ures. Accordingly, this section III.K.4 contains our satisfactory reporting criteria for group practices selected to participate in the GPRO. Please note that, for a group practice to participate in the PQRS GPRO in lieu of partic ipating as individual eligible professionals, a group practice is required to register to participate in the PQRS GPRO. For more information on GPRO participation, please visit http://www.cms.gov/Medicare/Quality-Initiatives-Patient-AssessmentInstruments/PQRS/Group_Practice_Reporting_Option.html . For more information on registration, please

visit http://www.cms.gov/Medicare/Medicare-Fee-for-Ser vice-Payment/PhysicianFeedbackProgram/SelfNomination-Registration.html

. a. Criteria for Satisfactory Reporting on PQRS Qua lity Measures Via the GPRO Web Interface for the 2017 PQRS Payment Adjustment Consistent with the group practice reporting requirements under section 1848(m)(3)(C) of the Act, we proposed to modify §414.90(j) to incorporat e the following criterion for the satisfactory reporting of PQRS quality measures for group practices register ed to participate in the GPRO for the 12-month reporting period for the 2017 PQRS payment adjust ment using the GPRO web interface for groups practices of 25–99 eligible professionals: The group practice would report on all measures included in the web interface; AND populate data fields for the firs t 248 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 248, then the group practice would report on 100 percent of assigned beneficiaries. In other words, we understand that, in some instances, the sampling methodology CMS provides will not be able to assign at least 248 patients on which a group practice may report, particularly those group practices on the smaller end of the range of 25–9 9 eligible professionals. If the group practice is assigned less than 248 Medicare beneficiaries, then the group practice wouldCMS-1612-FC 690

report on 100 percent of its assigned beneficiaries. A group practice would be required to report on at least 1 measure for which there is Medicare patient data. In addition, we proposed to modify §414.90(j) to incorporate the following criteria for the satisfactory reporting of PQRS quality measures for group practices that registered to participate in the GPRO for the 12-month reporting period for the 2017 PQRS payment adjustment using the GPRO web interface for groups practices of 100 or more eligible professionals: The group practice would report all CAHPS for PQRS survey measures via a certified surv ey vendor. In addition, the group practice would report on all measures included in the GPRO web in terface; AND populate data fields for the first 248 consecutively ranked and assigned beneficiaries in the or der 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 248, then the group practice would report on 100 percent of assigned beneficiaries. A group practice would be required to report on at least 1 measure for which there is Medicare patient data. To maintain consistency in this reporting criteria, we note that this criteria is similar to the criterion we finalized for the satisfactory reporting of PQRS quality measures for group practices selected to participate in the GPRO for the 12-month reporting periods for the 2013 and 2014 PQRS incentives for group practices of 100 or more eligible professionals in the CY 2013 PFS final rule with comment period (see Table 49 at 78 FR 74486). However, we propo sed to reduce the patient sample size on which a group practice is required to report quality measures data from 411 to 248. We examined the sample size of this reporting criterion and determined that the sample size we proposed reduces provider reporting burden while still allowing for statistically valid an d reliable performance resu lts. For the 25-99 sized groups reporting via the web interface, we recognized the proposal to move from reporting 218 to 248 patients per sample represents a slight increase in reporting. However, based on experience with the 218 count and subsequent statistical an alysis, we believe that there are increased performance reliabilities and validities gained when changing the minimum reporti ng requirement to 248. We believe statistical reliability and validity is extremely important when measuring provider performance, particularly given the implications of the Physician VM and Physicia n Compare public reporting, discussed in section III.NCMS-1612-FC 691

and section III.J respectively. Therefore, we believe this criterion improves on the criterion previously

finalized. For assignment of patients for group practices repor ting via the GPRO web interface, in previous years, we have aligned with the Medicare Shar ed Savings Program methodology of beneficiary assignment (see 77 FR 69195). We note that, in sec tion III.N. of the CY 2015 PFS proposed rule, we proposed to use a beneficiary attribution methodolog y for the VM for the claims-based quality measures and cost measures that is slightly different fro m the Medicare Shared Savings Program methodology, namely (1) eliminating the primary care service pre-step that is statutorily required for the Shared Savings Program and (2) including NPs, PA, and CNSs in step 1 rather than in step 2 of the attribution process. We believe that aligning with the VM’s proposed me thod of attribution is appropriate, as the VM is directly tied to participation in the PQRS. Therefor e, to achieve further alignment with the VM and for the reasons proposed in section III.N., we proposed to adopt the attribution methodology changes proposed for the VM into the GPRO web interf ace beneficiary assignment methodology. We invited public comment on these proposals. The following is summary of the comments we received regarding on these proposals. Comment: A majority of the commenters supported our proposal for a group practice of 25 or more eligible professionals using the GPRO web inte rface to report on a patient sample of 248. With respect to having group practices of 100 or more eligib le professionals report on a patient sample of 248 in lieu of 411 (the required patient sample for group pr actices of 100 or more eligible professionals for the 2014 PQRS incentive), the commenter s agreed that this would reduce the reporting burden while still ensuring statistically valid and reliable performance results. Response: We appreciate the commenters’ f eedback. Based on the positive comments received and for the reasons stated in the proposed rule, we are finalizing this proposal. Therefore, to meet the criteria for satisfactory reporting for the 2017 PQRS payment adjustment for a group practice of 25 or more eligible professionals using the GPRO web in terface, a group practice would be required to report on at least 248 patients.CMS-1612-FC 692

As a result of the comments, we are finalizing th e following criteria for satisfactory reporting for the 2017 PQRS payment adjustment for group practi ces comprised of 25 to 99 eligible professionals using the GPRO web interface: report on all measure s included in the web interface; AND populate data fields for the first 248 consecutively ranked and assigned beneficiaries in the order in which they appear in the group’s sample for each module or preven tive care measure. If the pool of eligible assigned beneficiaries is less than 248, then the group practice must report on 100 percent of assigned beneficiaries. In other words, we understand that , in some instances, the sampling methodology we provide will not be able to assign at least 248 patient s on which a group practice may report, particularly those group practices on the sma ller end of the range of 25–99 e ligible professionals. If the group practice is assigned less than 248 Medicare benefici aries, then the group practice must report on 100 percent of its assigned beneficiaries. A group practice must report on at least 1 measure for which there is Medicare patient data. In addition, we note that, in the past, we have not provided guidance on th ose group practices that choose the GPRO web interface to report PQRS qua lity measures but have seen no Medicare patients for which the GPRO measures are applicable, or if they ha ve no (that is, 0 percent) responses for a particular module or measure. Since we are moving solely towards the implementation of PQRS payment adjustments, we sought to clarify this scenario here. If a group practice has no Medicare patients for which any of the GPRO measures are applicable, the group practice will not meet the criteria for satisfactory reporting using the GPRO web interface. Therefore, to meet the criteria for satisfactory reporting using the GPRO web interface, a group practi ce must be assigned and have sampled at least 1 Medicare patient for any of the applicable GPRO we b interface measures (specified in Table 52). If a group practice does not typically see Medicare patients for which the GPRO web interface measures are applicable, we advise the group practice to particip ate in the PQRS via another reporting mechanism.

Please note that the discussion in this section III.K. 4.a is limited to the criteria for satisfactory reporting for the 2017 PQRS payment adjustment fo r group practices comprised of 25-99 eligible professionals who register to participate in the GPRO and who have at least 1 Medicare patient for which any of the GPRO measures are applicable. As we di scuss in greater detail in section III.K.4 below, sinceCMS-1612-FC 693

we are requiring that group practices report on CAHPS for PQRS, the final criteria for group practices comprised of 100 or more eligible professionals are addressed in section III.K.4.c . b. Criteria for Satisfactory Reporting on Individual PQRS Quality Measures for Group Practices Registered To Participate in the GPRO via Regist ry and EHR for the 2017 PQRS Payment Adjustment For registry reporting in the GPRO, in the CY 2014 PFS final rule with comment period (see Table 49 at 78 FR 74486), we finalized the following satisfactory reporting criteria for the submission of individual quality measures via registry for group prac tices comprised of 2 or more eligible professionals in the GPRO for the 2014 PQRS incentive: Report at least 9 measures, covering at least 3 of the NQS domains, OR, if less than 9 measures covering at least 3 NQS domains apply to the group practice, report 1—8 measures covering 1-3 NQS domains for which th ere is Medicare patient data, AND report each measure for at least 50 percent of the group pr actice’s Medicare Part B FFS patients seen during the reporting period to which the measure applies. Measu res with a 0 percent performance rate would not be counted. In the CY 2014 PFS final rule with comment pe riod, we signaled that it was “our intent to ramp up the criteria for satisfactory reporting for the 2017 PQRS payment adjustment to be on par or more stringent than the criteria for satisfactory reporting for the 2014 PQRS incentive” (78 FR 74465). Consistent with the criterion finalized for the 2014 PQRS incentive and the group practice reporting requirements under section 1848(m)(3)(C) of th e Act, for those group practices that choose to report using a qualified registry, we modified §414.90 (j) to include the following satisfactory reporting criterion via qualified registry for ALL group practices w ho select to participate in the GPRO for the 2017 PQRS payment adjustment: The group practice would report at least 9 measures, covering at least 3 of the NQS domains. Of these measures, if a group practi ce sees at least 1 Medicare patient in a face-to-face encounter, the group practice would report on at least 2 measures in the cross-cutting measure set specified in Table 52. If less than 9 measures cove ring at least 3 NQS domains apply to the eligible professional, the group practice would report up to 8 measures covering 1-3 NQS domains for which there is Medicare patient data, AND report each measure for at least 50 percent 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 perfo rmance rate would not be counted.CMS-1612-FC 694

As with individual reporting, we understand that there may be instances where a group practice may not have at least 9 measures applicable to a gr oup practice’s practice. In this instance, like the criterion we finalized for the 2014 PQRS incentive (see Table 49 at 78 FR 74486), a group practice reporting on less than 9 measures would still be able to meet the satisfactory reporting criterion via registry if the group practice reports on as many measures as are applicable to the group practice’s practice. If a group practice reports on less than 9 me asures, the group practice would be subject to the MAV process, which would allow us to determine whether a group practice should have reported quality

data codes for additional measures and/or measures covering additional NQS domains. Please note that this MAV process does not apply to the application of the cross-cutting measure reporting requirement, as we require that all group practices report on at least 1 cross-cutting measure if an eligible professional in the group practice see at least sees at least 1 Me dicare patient in a face-to-face encounter. The MAV process we proposed to implement for registry re porting is the same process that was established for reporting periods occurring in 2014 for the 2014 PQRS incentive. For more information on the registry MAV process, please visit http://www.cms.gov/Medicare/Quality -Initiatives-Patient-AssessmentInstruments/PQRS/Downloads/2014_PQRS_Regist ry_MeasureApplicabilityValidation_12132013.zip

. For EHR reporting, consistent with the criterion fi nalized for the 2014 PQRS incentive that aligns with the criteria established for meeting the CQM co mponent of meaningful use under the Medicare EHR Incentive Program and in accordance with the group practice reporting requirements under section 1848(m)(3)(C) of the Act, for those group practices that choose to report using an EHR, we proposed to modify §414.90(j) to indicate the following satisfactory reporting criterion via a direct EHR product that

is CEHRT or an EHR data submission vendor that is CEHRT for ALL group practices who select to participate in the GPRO for the 2017 PQRS payment adjustment: For the 12-month reporting period for the 2017 PQRS payment adjustment, the group prac tice would report 9 measures covering at least 3 domains. If the group practice’s CEHRT does not contain patient data for at least 9 measures covering at least 3 domains, then the group practice must report th e measures for which there is patient data. A group practice must report on at least 1 measure for which th ere is Medicare patient da ta. We invited publicCMS-1612-FC 695

comment on these proposals. The following is summary of the comments we received regarding on these proposals. Comment: The majority of commenters opposed our proposal to require the reporting of 9 measures to meet the criteria for satisfactory repor ting for the 2017 PQRS payment adjustment. Some commenters supported the reporting of 9 measures when using the EHR reporting mechanisms, indicating that the proposed criterion aligns with the criterion for meeting the eCQM component of meaningful use under the EHR Incentive Program. Some of the commenters opposing this proposal noted that group practices have been successful at meeting the crite ria for satisfactory reporting for the PQRS incentives and payment adjustments in the past by reporting 3 measures, and increasing the number of measures to be reported would make it more difficult for these gro up practices to meet the criteria for satisfactory reporting for the 2017 PQRS payment adjustment. Ot her commenters also noted that certain group practices do not have 9 measures covering 3 NQS domains to report. For these reasons, some commenters suggested a more gradual approach to re quiring the reporting of at least 9 measures covering 3 NQS domains, such as requiring the reporting of 5 or 6 measures rather than 9 measures. A few commenters also recommended establishing a lower reporting threshold for those group practices practicing in specialties for wh ich few PQRS measures exist. Response: While we understand the commenters con cerns related to requiring the reporting of 9 measures covering up to 3 NQS domains, we believe we provided the public with adequate time to prepare to reporting criteria that requires the reporting of 9 measures. For example, we finalized criteria for the satisfactory reporting for the 2016 PQRS paym ent adjustment via registry that only required the reporting of 3 measures covering 1 NQS domain (see Table 50 at 78 FR 74486). However, we also finalized criteria for the 2016 PQRS payment adjust ment using the registry- and EHR-based reporting mechanisms that aligned with the criteria we fina lized for the 2014 PQRS incentive that generally required reporting of at least 9 m easures covering at least 3 NQS domains. Additionally, in the CY 2014 PFS final rule, we noted that "it is our intent to ra mp up the criteria for satisfactory reporting for the 2017 PQRS payment adjustment to be on par or more stri ngent than the criteria for satisfactory reporting for the 2014 PQRS incentive" (78 FR 74465). We belie ve that establishing criteria for the satisfactoryCMS-1612-FC 696

reporting of the 2016 PQRS payment adjustment that ar e consistent with this proposed criteria, as well as signaling our intent to ramp up the satisfactory re porting criteria, provided enough advanced notice to encourage eligible professionals to prepare to repor t 9 measures to meet the criteria for satisfactory reporting for the 2017 PQRS payment adjustment. Furthermore, with respect to those commenters concerned that a group practice may not have 9 measures covering at least 3 NQS domains applicable to his or her practice, in the proposed rule, with respect to reporting via registry, we noted that “as w ith individual reporting, we understand that there may be instances where a group practice may not have at least 9 measures applicable to a group practice’s practice. In this instance, like the criterion we fina lized for the 2014 PQRS in centive (see Table 49 at 78 FR 74486), a group practice reporting on less than 9 meas ures would still be able to meet the satisfactory reporting criterion via registry if the group practice reports on as many measures as are applicable to the group practice’s practice” (79 FR 40399). Under this proposed criterion for satisfactory reporting for the 2017 PQRS payment adjustment for group practices re porting via registry, a group practice who does not have at least 9 measures covering at least 3 NQS domai ns applicable to the practice may still meet the criteria for satisfactory reporting for the 2017 PQRS payment adjustment provided that the group practice reports all measures as are applicable to his or her practice. With respect to reporting via an EHR, we noted that if the group practice’s CEHRT does not contain patient data for at least 9 measures covering at least 3 domains, then the group practice must report the measures for which there is patient data. A group practice must report on at least 1 measure for which there is Medicare patient data.

Based on the comments received and for the reasons stated above and in the proposed rule, we are finalizing our proposal to require the reporting of 9 measures covering at least 3 NQS domains via registry and EHR to meet the criteria for satisfact ory reporting for the 2017 PQRS payment adjustment. Comment: Commenters provided the same comments for requiring the reporting of cross-cutting measures for group practice reporting as individual re porting in section III.K.2.a. Some commenters provided general support for the option to report cros s-cutting measures via registry, as it may help bring alignment with respect to a set of measures all gr oup practices may report. However, most of theseCMS-1612-FC 697

commenters believed that the reporting of cross-cu tting measures should be voluntary, not mandatory. The majority of commenters opposed our proposal to require a group practice that sees at least 1 Medicare patient in a face-to-face encounter during the 12-month 2017 PQRS payment adjustment reporting period to report at least 2 measures contained in the proposed cross-cutting measure set specified in Table 21 of the CY 2015 PFS proposed rule (79 FR 40395). Some of these commenters believed the proposed requirement to be unfair, as th e requirement to report on at least 2 cross-cutting measures placed an additional burden on certain specialists and not others. Other commenters emphasized that the cross-cutting measures did not appl y to many specialty practices. Contrary to these commenters, some commenters expressed support for this proposal. Some of those who supported, this proposal, however, recommended a more phased-in appro ach to the reporting of cross-cutting measures. One of these commenters recommended that the proposal be amended to require only the reporting of 1 measure in the cross-cutting measure set. Some of these commenters were confused as to whether this proposal would increase the proposed number of measures to be reported to 11 measures. Response: Please note that our responses to th ese comments are the same responses we provided previously regarding our proposal to require the reporting of cross-cutting measures for individual reporting. Therefore, based on the comments received and for the reasons stated previously and in the proposed rule, we are modifying our proposal to require that a group practice who sees at least 1 Medicare patient in a face-to-face encounter during the 12-month 2017 PQRS payment adjustment reporting period report at least 1 me asure contained in the cross-cutt ing measure set we are finalizing specified in Table 52. Please note that this does not bring the total num ber of measures required to be reported under this criterion to 10 measures. Rather, if a group practice sees at least 1 Medicare patient in a face-to-face encounter during the 12-month PQRS payment adjust ment reporting period, 1 of the 9 measures the group practice reports must be measures contained in th e cross-cutting measure set. Therefore, a group practice would report at least 1 cross-cutti ng measure and 8 additional PQRS measures. In the instance where a group practice may not have at least 9 measures applicable to his/her practice, the eligible professional would still be requi red to report at least 1 cross-cutting measure, ifCMS-1612-FC 698

applicable. If a group practice reporting on less than 9 measures does not have at least 1 cross-cutting measure applicable to his or her practice, then the group practice would report on as many measures as our applicable to his or her practice.

Comment: One commenter believes that the thr eshold of seeing 1 Medicare patient in a face-toface encounter for the requirement to report on cro ss-cutting measures is too low. The commenter was concerned that this would further burden group practices who rarely see Medicare patients. Response: We understand the commenter’s concern. However, as we believe in the importance of the cross-cutting measures set we are finalizing in Table 52, it is our desire to encourage reporting of the measures contained in the cross-cutting measures set when applicable. We proposed this threshold to exclude certain specialties that do not see Medicare pati ents. However, we expect those group practices that see Medicare patients to report on the cr oss-cutting measures we specify in Table 52. Comment: One commenter sought clarification on the definition of a face-to-face encounter by specifying which codes apply to this definition and ur ged that procedural encounters not be included in

the list of face-to-face encounters. Response: As we stated in the proposed rule, we will determine whether an eligible professional in a group practice had a ‘‘face-to-face’’ encounter by seeing whether the eligible professional billed for

services under the PFS that are associated with face- to-face encounters, such as whether an eligible professional billed general office visit codes, outpatient visits, and surgical procedures. We would not

include telehealth visits as face-to-face encounters fo r purposes of the proposals requiring reporting of at least 2 cross-cutting measures specified in Table 52. While we will not provide the specific codes for

what we definite as a “face-to-face” encounter he re, we will provide additional guidance on the PQRS

website at http://www.cms.gov/Medicare/Quality-Initiatives-Patient-AssessmentInstruments/PQRS/index.html

. Comment: Some commenters opposed our proposal to require that, to meet the criteria for satisfactory reporting for the 2017 PQRS payment adjustment, a group practice reporting individual measures via registry 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 th e measure applies. The commenters noted that,CMS-1612-FC 699

particularly for those group practices that see many patients, requiring the reporting of quality measures for more than 50 percent of the group practice’s Medi care Part B FFS patients is an enormous burden. Response: We understand this c oncern, particularly with those group practices that see a large number of patients. However, it is important to co llect sufficient quality measu res data to ensure an adequate sample. We also believe that requiring that a group practice report on at least 50 percent of its Medicare Part B FFS patients helps to prevent potenti al selection bias that could skew the representation of quality of care; while the potential for selection bias still remains, we were mindful of concerns about provider burden during this period where group practices are still becoming accustomed to PQRS reporting. Based on the comments received and for the r easons stated above and in the proposed rule, we are finalizing our proposal to require that, to meet the criteria for satisfactory reporting for the 2017 PQRS payment adjustment, a group practice reporting indivi dual measures via registry 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. Comment: Some commenters generally suppor ted the MAV process. However, some commenters expressed the need to clarify the MAV process for registry as well as to provide greater transparency in this process. Response: We understand the need to clarify further the MAV process for both claims and registry. Please note that, as the MAV process evolves, we expect to be able to provide further guidance to aid group practices in understa nding the MAV process. We will post additional clarifying information, including a “made simple” document on the MAV process for 2015 on the PQRS website at http://www.cms.gov/Medicare/Quality-Initiatives-Pa tient-Assessment-Instruments/pqrs/index.html . We believe that posting this guidance as we have in year s prior provides adequate transparency in this process. Moreover, should a group practice have furt her questions regarding the MAV process, he/she may contact our QualityNet Help Desk for more inform ation. The contact information for the Help Desk

can be found here: http://www.cms.gov/Medicare/Quality -Initiatives-Patient-AssessmentInstruments/PQRS/HelpDeskSupport.html

.CMS-1612-FC 700

Because of the comments, we are finalizing our proposal to modify §414.90(j) and finalize the following criteria for satisfactory re porting for group practices participati ng in the GPRO via registry and EHR for the 2017 PQRS payment adjustment: For group practices comprised of 2-99 eligible professionals reporting fo r the 12-month reporting period for the 2017 PQRS payment adjustment via registry, report at least 9 measures, covering at least 3 of the NQS domains. Of these measures, if a group pr actice sees at least 1 Medicare patient in a face-toface encounter, the group practice would report on at least 1 measure in the cross-cutting measure set specified in Table 52. If less than 9 measures covering at least 3 NQS domains apply to the group practice, the group practice would report up to 8 meas ures covering 1–3 NQS domains for which there is Medicare patient data, AND report each measure for at least 50 percent of the group’s Medicare Part B FFS patients seen during the reporting period to which th e measure applies. Measures with a 0 percent performance rate would not be counted. We understand that there may be instances where a group practice may not have at least 9 measures applicable to an eligible professional’s pr actice. In this instance, a group practice reporting on

less than 9 measures would still be able to meet the satisfactory reporting criterion via claims and registry if the group practice reports on 1-8 measures, as appli cable, to the group’s practice. If a group practice reports on 1-8 measures, the group practice would be subject to the MAV process, which would allow us to determine whether a group practice should have repor ted quality data codes for additional measures. In addition, the MAV will also allow us to determin e whether a group practice should have reported on any of the cross-cutting measures specified in Table 52. The MAV process we will implement for claims and registry for the 2017 PQRS payment adjustment is the same process that w as established for reporting periods occurring in 2014 for the 2014 PQRS incentive. For more information on the claims MAV process, please visit http://www.cms.gov/Medicare/Quality-Initiatives-Patient-AssessmentInstruments/PQRS/Downloads/2014_PQRS_Clai ms_MeasureApplicabilityValidation_12132013.zip . For more information on the registry MAV process, please visit http://www.cms.gov/Medicare/QualityInitiatives-Patient-AssessmentInstruments/PQRS/Downloads/2014_PQRS_Regist ry_MeasureApplicabilityValidation_12132013.zip

.CMS-1612-FC 701

For group practices comprised of 2-99 eligible professionals reporting fo r the 12-month reporting period for the 2017 PQRS payment adjustment via EHR: report 9 measures covering at least 3 domains. If the group practice’s CEHRT does not contain patient data for at least 9 measures covering at least 3 domains, then the group practice must report the m easures for which there is patient data. A group practice must report on at least 1 measure fo r which there is Medicare patient data.

Please note that the discussion in this section III.K.4. b is limited to the criteria for the satisfactory reporting of group practices registered to participate in the GPRO for the 2017 PQRS payment adjustment using the EHR-based reporting mechanism to group prac tices comprised of 2-99 eligible professionals. The final criteria for group practices comprised of 10 0 or more eligible professionals are addressed in section III.K.1.c. following this section. c. Criteria for Satisfactory Reporting on Individual PQRS Quality Measures for Group Practices Registered to Participate in the GPRO via a CM S-Certified Survey Vendor for the 2017 PQRS Payment Adjustment

In the CY 2014 PFS final rule with comment period, we introduced satisfactory reportingcriterion for the 2014 PQRS incentive related to reporting the CG CAHPS survey measures via a CMScertified survey vendor (see Table 49 at 78 FR 74486). Consistent with the criterion finalized for the 2014 PQRS incentive and the group practice reporti ng requirements under section 1848(m)(3)(C) of the Act, we proposed 3 options (of which a group practice w ould be able to select 1 out of the 3 options) for satisfactory reporting for the 2017 PQRS payment adjustment for group practices comprised of 25 or more eligible professionals (79 FR 40399). Furthermore, as was required for group practices reporting via the GPRO web interface for the reporting periods occurring in 2014 (78 FR 74485), we proposed that all group practices comprised of 100 or more eligible professionals that register to participate in the PQRS GPRO, regardless of the reporting mechanism the group practice chooses, would be required to select a CMS-certified survey vendor to administer the CAHPS for PQRS survey on their behalf. As such, for purposes of meeting the criteria for satisfactory reporting for the 2017 PQRS pa yment adjustment, a group practice participating in the PQRS GPRO would be required to use 1 of these 3 proposed reporting options mentioned above (thatCMS-1612-FC 702

is, GPRO web interface, qualified registry or EHR). We noted that, for reporting periods occurring in 2014, we stated that we would administer and fund the collection of (CG-CAHPS) data for these groups (of 100 or more eligible professionals using the GPRO web interface that are required to report on CAHPS for PQRS survey measures) (78 FR 74452). We stated that we would bear the cost of administering the CAHPS for PQRS survey measures, as we were requiring the group practices to report on CAHPS for PQRS survey measures. Unfortunately , beginning in 2015, it will no longer be feasible for us to continue to bear the cost of group practi ces of 100 or more eligible professionals to report the CAHPS for PQRS survey measures. Therefore, the gr oup practice would be required to bear the cost of administering the CAHPS for PQRS survey measures. However, as CAHPS for PQRS was optional for group practices comprised of 25-99 eligible professionals in 2014 (78 FR 74485) and whereas we proposed to require reporting of CAHPS for PQRS for group practices comprised of 100 or more eligible professionals, we proposed that CAHPS for PQRS would be optional for groups of 25-99 and 2-24 e ligible professionals. We not ed that all group practices that would be required to report or voluntarily elect to report CAHPS for PQRS would need to select and pay a CMS-certified survey vendor to administer the CAHPS for PQRS survey on their behalf. We invited public comment on these proposals rela ted to our proposals to require reporting of CAHPS for PQRS for group practices comprised of 100 or more eligible professionals that register to participate in the PQRS GPRO as well as our proposal making the reporting of CAHPS for PQRS optional for group practices comprised of 2-99 eligible professionals that registry to participate in the PQRS GPRO to meet the criteria for satisfactory reporting for the 2017 PQRS payment adjustment. The following is a summary of the comments we received regarding on these proposals. Comment: Commenters supported the option to report CAHPS for PQRS, as long as reporting CAHPS for PQRS remained optional. The majority of commenters opposed our proposal to require group practices comprised of 100 or more eligible prof essionals that register to participate in the PQRS GPRO, regardless of the reporting mechanism the group practice chooses, to select a CMS-certified survey vendor to administer the CAHPS for PQRS su rvey on their behalf. These commenters believe that this requirement was too burdensome, particularly be cause CMS is not bearing the cost of administeringCMS-1612-FC 703

the survey. Some of these comment ers requested that CMS delay requiring the reporting of CAHPS for PQRS to the 2016 reporting period. Other commenters re quested that CMS continue to bear the cost of administering the CAHPS for PQRS survey. Response: While we understand the commenters’ concerns regarding requiring the reporting of CAHPS for PQRS, group practices comprised of 100 or more eligible professionals participating in the GPRO web interface reporting option have had 2 year s of experience reporting CAHPS for PQRS as they have been required to report CAHPS for PQRS for both the 2013 and 2014 PQRS incentive. Groups of 25-99 eligible professionals reporting via GPRO web in terface, qualified registry or EHR and groups of 100 or more eligible professionals reporting via qu alified registry or EHR had the option to report CAHPS for PQRS in 2014. We believe that 2 year s is enough time to become familiar with how the survey is administered. Therefore, we believe it is reasonable to require group practices of 100 of more eligible professionals to report on CAHPS for PQRS. With respect to some commenters’ concerns about the additional burden the proposal to require group practices comprised of 100 or more eligible professionals that register to participate in th e PQRS GPRO to report CAHPS for PQRS places on these group practices, we understand that this proposed re quirement could bring a dditional reporting burden on these larger group practices. We believe that the va lue of the information contained in the CAHPS for PQRS survey outweighs this concer n. In addition, we note that large group practices tend to be more sophisticated than other group practices with respect to resources, and, as such, we believe that this mitigates any additional burden on group practices of 100 or more eligible professionals. Therefore, based on the reasons we state here and in the propo sed rule, we are finalizing our proposal to require reporting of CAHPS for PQRS for group practices compri sed of 100 or more eligible professionals that register to participate in the PQRS GPRO. We are also finalizing our proposal to make th e reporting of CAHPS for PQRS optional for group practices comprised of 2-99 eligible professionals that register to participate in the PQRS GPRO to meet the criteria for satisfactory reporting for the 2017 PQRS payment adjustment. Furthermore, we understand the commenters’ con cerns regarding having the group practices bear the cost of administering the CAHPS for PQRS surv ey, particularly for those group practices who will beCMS-1612-FC 704

required to report CAHPS for PQRS to meet the crit eria for satisfactory reporting for the 2017 PQRS payment adjustment. However, it is not feasible for us to continue to bear the cost of administering the CAHPS for PQRS survey. We believe that bearing th e cost of the CAHPS for PQRS survey for 2013 and 2014 provided adequate time for group practices to b ecome familiar with administering the CAHPS for PQRS survey as well as signaled our commitment to reporting of the CAHPS for PQRS survey into the

future. Because of the comments received, we are finalizing the following final criteria for satisfactory reporting for the 2017 PQRS payment adjustment for group practices comprised of 2 or more eligible professionals. The following options are voluntary ways to meet the criteria for satisfactory reporting for the 2017 PQRS payment adjustment for groups compri sed of 2-99 eligible professionals. However, group practices comprised of 100 or more eligible prof essionals that are registered to participate in the GPRO must select one of these options to meet the criteria for satisfactory reporting for the 2017 PQRS payment adjustment. Option 1 – Registry: If a group practice of 2 or more eligible professionals chooses to use a qualified registry, in conjunction with reporting the CAHPS for PQRS survey measures, for the 12-month reporting period for the 2017 PQRS payment adjustme nt, the group practice must have all CAHPS for PQRS survey measures reported on its behalf via a CMS-certified survey vendor, and report at least 6 additional measures, outside of CAHPS for PQRS, covering at least 2 of the NQS domains using the qualified registry. If less than 6 measures apply to the group practice, the group practice must report up to

5 measures. Of the additional measures that must be reported in conjunction with reporting the CAHPS for PQRS survey measures, if any eligible professi onal in the group practice sees at least 1 Medicarepatient in a face-to-face encounter, the group practice must report on at least 1 measure in the crosscutting measure set specified in Table 52. Consistent with the group practice reporting option solely using a qualified registry for the 2017 PQRS payment adjustment, we understand that ther e may be instances where a group practice may not have at least 6 measures applicable to a group prac tice’s practice. In this instance, a group practice reporting on less than 6 measures would still be able to meet the satisfactory reporting criterion viaCMS-1612-FC 705

registry if the group practice reports on as many measures as are applicable to the group practice’s practice, including the measures in the cross-cutting measure set specified in Table 52. If a group practice reports on less than 6 individual measures using the qualified registry reporting mechanism in conjunction with a CMS-certified survey vendor to report CAH PS for PQRS, the group practice would be subject to the MAV process, which would allow us to determ ine whether a group practice should have reported quality data codes for additional measures and/or me asures covering additional NQS domains. For more information on the registry MAV process, please visit http://www.cms.gov/Medicare/Quality-InitiativesPatient-AssessmentInstruments/PQRS/Downloads/2014_PQRS_Regist ry_MeasureApplicabilityValidation_12132013.zip

. Option 2 – EHR: If a group practice of 2 or more eligible professionals chooses to use a direct EHR product that is CEHRT or EHR data submi ssion vendor that is CEHRT in conjunction with reporting the CAHPS for PQRS survey measures, fo r the 12-month reporting period for the 2017 PQRS payment adjustment, the group practice must have a ll CAHPS for PQRS survey measures reported on its behalf via a CMS-certified survey vendor, and report at least 6 additional measures, outside of CAHPS for PQRS, covering at least 2 of the NQS domains using the direct EHR product that is CEHRT or EHR data submission vendor product that is CEHRT. If l ess than 6 measures apply to the group practice, the group practice must report up to 5 measures. Of th e additional 6 measures that must be reported in conjunction with reporting the CAHPS for PQRS survey measures, a group practice would be required to report on at least 1 measure for which there is Medicare patient data. Option 3 – GPRO Web Interface: Alternativel y, if a group practice of 25-99 eligible professionals chooses to use the GPRO web interface in conjunction with reporting the CAHPS for PQRS survey measures, for the 12-month reporting period for the 2017 PQRS payment adjustment, the group practice must have all CAHPS for PQRS survey measures reported on its behalf via a CMS-certified survey vendor. In addition, the group practice must report on all measures included in the GPRO web interface; AND populate data fields for the first 248 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 248 , then the group practice must report on 100 percentCMS-1612-FC 706

of assigned beneficiaries. A group practice will be re quired to report on at least 1 measure for which there is Medicare patient data. Tables 50 and 51 provide a summary of the final crite ria for satisfactory reporting – or, in lieu of satisfactory reporting, satisfactory participation in a QCDR – for the 2017 PQRS payment adjustment for eligible professionals and group practices. As y ou can see below, there are a total of 5 individual reporting options and 9 group practice reporting options . Therefore, there are a total of 14 reporting options under the PQRS for purposes of meeting the criteria for satisfactory reporting – or, in lieu of satisfactory reporting, satisfactory participation in a QCDR – for the 2017 PQRS payment adjustment. d. The Consumer Assessment of Healthcare Providers Surgical Care Survey (S-CAHPS) In addition to CAHPS for PQRS, we received comme nts last year supporting the inclusion of the

Consumer Assessment of Healthcare Providers Su rgical Care Survey (S-CAHPS). The S-CAHPS expands on the CG-CAHPS by focusing on aspects of surgical quality, which are important from the patient’s perspective and for which th e patient is the best source of information. The survey asks patients to provide feedback on surgical car e, surgeons, their staff, and anesthesia care. It assesses patients’ experiences with surgical care in both the inpatient and outpatient settings by asking respondents about their experience before, during and after surgery. The commenters stated that the CG-CAHPS survey would not accurately reflect the care provided by single - or multispecialty surgical or anesthesia groups.

The commenters noted that S-CAHPS has been test ed by the same standards as CG-CAHPS and follows

the same collection mechanism as the CG-CAHPS. We agree with the commenters on the importance of allowing for the administration of S-CAHPS reporting a nd wish to allow for reporting of S-CAHPS in the PQRS for reporting mechanisms other than the QCDR. However, at this time, due to the cost and time it

would take to find vendors to co llect S-CAHPS data, it is not technically feasible to implement the reporting of the S-CAHPS survey measures for the 2017 PQRS payment adjustment. In the CY 2015 PFS proposed rule (79 FR 40400), we solicited comme nts on how to allow for reporting of the S-CAHPS survey measures for the 2018 PQRS payment adjustme nt and beyond. In addition, we sought comments on how to allow for reporting of the S–CAHPS survey measures for the 2018 PQRS payment adjustment and beyond. The following is a summary of the comments we received on these proposal:CMS-1612-FC 707

Comment: The majority of commenters supported the introduction of S-CAHPS in the PQRS. These commenters supported our proposal to allow th e reporting of S-CAHPS via a QCDR, and other commenters requested that group practices be able to report S-CAHPS via a CMS-certified survey vendor, similar to the way CAHPS for PQRS is cu rrently being reported under the PQRS. Other commenters expressed concerns on introducing S-CAH PS for the PQRS. One commenter stated that SCAHPS does not adequately capture the patient and caregiver experience with all types of anesthesia professionals. Another commenter expressed concerns related to determining how to select patients for

which to administer S-CAHPS. Commenters were also concerned with the financial burden of administering the S-CAHPS survey, and asked CMS to explore ways to fund the administration of the SCAHPS survey. Response: We appreciate the commenters’ feedback. However, at this time, due to the cost and

time it would take to find vendors to collect S-CAHPS da ta, it is not technically feasible to implement the reporting of the S-CAHPS survey measures for the 2017 or 2018 PQRS payment adjustments. We note, however, that if a QCDR wishes to administer th e S-CAHPS as a non-PQRS measure for the 2017 or 2018 PQRS payment adjustments, we would allow the QCDR to do so. We will take these comments

into consideration as we continue to work to in troduce S-CAHPS in the PQRS measure set for future

years.CMS-1612-FC 708

TABLE 50: Summary of Requirements for the 2017 PQRS Payment Adjustment: Individual Reporting Criteria for the Satisfactory Reporting of Quality Measures Data via Claims, Qualified Registry, and EHRs and Satisfac tory Participation Criterion in QCDRs Reporting Period Measure Type Reporting Mechanism Satisfactory Reporting/Satisf actory Participation Criteria

12-month (Jan 1– Dec 31, 2015) Individual Measures Claims Report at least 9 measures, coveri ng at least 3 of the NQS domains AND report each measure for at l east 50 percent of the eligible professional’s Medicare Part B FFS patients seen during the reporting period to which the meas ure applies. Of the measures reported, if the eligible professional sees at least 1 Medicare patient in a face-to-face encounte r, the eligible professi onal will report on at least 1 measure contained in the proposed cross-cutting measure set specified in Table 52. If less than 9 measures apply to the eligible professional, the eligible professional would report up to 8 measure(s), AND report each measure for at least 50 percent of the Medicare Part B FFS patients seen during the reporting period to which the measure applies. Measur es with a 0 percent performance rate would not be counted. 12-month (Jan 1– Dec 31, 2015) Individual Measures Qualified Registry Report at least 9 measures, coveri ng at least 3 of the NQS domains AND report each measure for at l east 50 percent of the eligible professional’s Medicare Part B FFS patients seen during the reporting period to which the meas ure applies. Of the measures reported, if the eligible professional sees at least 1 Medicare patient in a face-to-face encounte r, the eligible professi onal will report on at least 1 measure contained in the proposed cross-cutting measure set specified in Table 52. If less than 9 measures apply to the eligible professional, the eligible professional would report up to 8 measure(s), AND report each measure for at least 50 percent of the Medicare Part B FFS patients seen during the reporting period to which the measure applies. Measur es with a 0 percent performance rate would not be counted. 12-month (Jan 1– Dec 31, 2015) Individual Measures Direct EHR Product or EHR Data Submission Vendor Product Report 9 measures covering at l east 3 of the NQS domains. If an eligible professional’s direct EHR product or EHR data submission vendor product does not contain patient data for at least 9 measures covering at least 3 domains, then the eligible professional would be required to report all of the measures for which there is Medicare patient data. An eligible professional would be required to report on at least 1 measure for which there is Medicare patient data. 12-month (Jan 1– Dec 31, 2015) Measures Groups Qualified Registry Report at least 1 measures grou p AND report each measures group for at least 20 patients, the majority (11 patients) of which are required to be Medicare Part B FFS patients. Measures groups containing a measure with a 0 percent performance rate will not be counted. 12-month (Jan 1– Dec 31, 2015) Individual PQRS measuresand/or nonPQRS measures reportable via a QCDR Qualified Clinical Data Registry (QCDR) Report at least 9 measures available for reporting under a QCDR covering at least 3 of the NQS domains, AND report each measure for at least 50 percent of the eligib le professional’s patients. Of these measures, the eligible professional would report on at least 2 outcome measures, OR, if 2 outcomes measures are not available, report on at least 1 outcome measur es and at least 1 of the following types of measures – resource use, patient experience of care, efficiency/appropriate use, or patient safetyCMS-1612-FC 709

TABLE 51: Summary of Requirements for the 201 7 PQRS Payment Adjustment: Group Practice Reporting Criteria for Satisfactory Reportin g of Quality Measures Data via the GPRO

Reporting Period Group Practice Size Measure Type Reporting Mechanism Satisfactory Reporting Criteria

12-month (Jan 1– Dec 31, 2015) 25-99 eligible professio nals Individual GPRO Measures in the GPRO Web Interface GPRO Web Interface Report on all measures included in the web interface; AND populate data fields for the first 248 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 248, then the group practice must report on 100 percent of assigned beneficiaries. In other words, we understand that, in some instances, the sampling methodology we provide will not be able to assign at least 248 patients on which a group practice may report, particularly those group practices on the smaller end of the range of 25–99 eligible professionals. If the group practice is assigned less than 248 Medicare beneficiaries, then the group practice must report on 100 percent of its assigned beneficiaries. A group practice must report on at least 1 measure for which there is Medicare patient data. 12-month (Jan 1– Dec 31, 2015) 25-99 eligible professio nals and100+ eligible professio nals Individual GPRO Measures in the GPRO Web Interface + CAHPS for PQRS GPRO Web Interface +CMSCertified Survey Vendor The group practice must have all CAHPS for PQRS survey measures reported on its behalf via a CMScertified survey vendor. In addition, the group practice must report on all measures included in the GPRO web interface; AND populate data fields for the first 248 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 248, then the group practice must report on 100 percent of assigned beneficiaries. A group practice will be required to report on at least 1 measure for which there is Medicare patient data. 12-month (Jan 1– Dec 31, 2015) 2-99 eligible professio nals Individual Measures Qualified Registry Report at least 9 measures, covering at least 3 of the NQS domains. Of these measures, if a group practice sees at least 1 Medicare patient in a face-to-face encounter, the group practice would report on at least 1 measure in the cross-cutting measure set specified in Table 52. If less than 9 measures covering at least 3 NQS domains apply to the group practice, the group practice would report up to 8 measures covering 1–3 NQS domains for which there is Medicare patient data, AND report each measure for at least 50 percent of the group’s Medicare 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. 12-month (Jan 1– Dec 31, 2015) 2-99 eligible professio nals and 100+ eligible professio Individual Measures + CAHPS for PQRS Qualified Registry +CMSCertified Survey Vendor The group practice must have all CAHPS for PQRS survey measures reported on its behalf via a CMScertified survey vendor, and report at least 6 additional measures, outside of CAH PS for PQRS, covering at least 2 of the NQS domains using the qualified registry. If less than 6 measures appl y to the group practice, the group practice must report up to 5 measures. Of theCMS-1612-FC 710

Reporting Period Group Practice Size Measure Type Reporting Mechanism Satisfactory Reporting Criteria

nals additional measures that must be reported in conjunction with reporting the CAHPS for PQRS survey measures, if any eligible professional in the group practice sees at least 1 Medicare patient in a face-to-face encounter, the group practice must report on at least 1 measure in the cross-cutting measure set specified in Table 52. 12-month (Jan 1– Dec 31, 2015) 2-99 eligible professio nals Individual Measures Direct EHR Product or EHR Data Submission Vendor Product Report 9 measures covering at least 3 domains. If the group practice’s direct EHR product or EHR data submission vendor product does not contain patient data for at least 9 measures coveri ng at least 3 domains, then the group practice must repor t the measures for which there is patient data. A group practice must report on at least 1 measure for which there is Medicare patient data. 12-month (Jan 1– Dec 31, 2015) 2-99 eligible professio nals and 100+ eligible professio nals Individual Measures + CAHPS for PQRS Direct EHR Product or EHR Data Submission Vendor Product +CMSCertified Survey Vendor The group practice must have all CAHPS for PQRS survey measures reported on its behalf via a CMScertified survey vendor, and report at least 6 additional measures, outside of CAH PS for PQRS, covering at least 2 of the NQS domains using the direct EHR product or EHR data submission vendor product. If less than 6 measures apply to th e group practice, the group practice must report up to 5 measures. Of the additional 6 measures that must be reported in conjunction with reporting the CAHPS for PQRS survey measures, a group practice would be required to report on at least 1 measure for which there is Medicare patient data.

5. Statutory Requirements and Ot her Considerations for the Selection of PQRS Quality Measures for Meeting the Criteria for Satisfactory Reporting for 20 15 and Beyond for Individual Eligible Professionals and Group Practices CMS undergoes an annual Call for Measures that solicits new measures from the public for possible inclusion in the PQRS. During the Call fo r Measures, we request measures for inclusion in PQRS that meet the following statutory and non-statutory criteria. Sections 1848(k)(2)(C) and 1848(m)(3)(C)(i) of the Act, respectively, govern the quality measures reported by individual eligible professi onals and group practices under the PQRS. Under section 1848(k)(2)(C)(i) of the Act, the PQRS quality me asures shall be such me asures selected by the Secretary from measures that have been endorsed by th e entity with a contract with the Secretary under section 1890(a) of the Act, which is currently the Na tional Quality Forum (NQF). However, in the case of a specified area or medical topic determined a ppropriate 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 theCMS-1612-FC 711

Secretary 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 Ambulatory Quality Alliance (AQA). In light of thes e statutory requirements, we believe that, except in the circumstances specified in the statute, each PQ RS quality measure must be endorsed by the NQF. Additionally, section 1848(k)(2)(D) of the Act requi res that for each PQRS quality measure, ‘‘the Secretary shall ensure that eligible professionals have the opportunity to provide input during the development, endorsement, or selection of measures a pplicable to services they furnish.” The statutory requirements under section 1848(k)(2)(C) of the Act, s ubject to the exception noted previously, require only that the measures be selected from measures that have been endorsed by the entity with a contract with the Secretary under section 1890(a) of the Ac t (that is, the NQF) and are silent as to how the

measures that are submitted to the NQF for endorsement are developed. The basic steps for developing measures applicable to physicians and othe r eligible professionals prior to submission of the measures for endorsement may be carried out by a variety of different organizations. We do not believe there need to be special restrictions on the type or make-up of the organizations carrying out this basic process of deve lopment of physician measures, such as restricting the initial development to physician-controlled organi zations. Any such restriction would unduly limit the basic development of quality measures and the sc ope and utility of measures that may be considered for endorsement as voluntary consensus standards for purposes of the PQRS. In addition to section 1848(k)(2)(C) of the Act, section 1890A of the Act, which was added by section 3014(b) of the Affordable Care Act, requires that the Secretary establish a pre-rulemaking process under which certain steps occur with respect to the selection of certain categories of quality and efficiency measures, one of which is that the entity with a c ontract with the Secretary under section 1890(a) of the Act (that is, the NQF) convene multi-st akeholder groups to provide input to the Secretary on the selection of such measures. These categories are described in section 1890(b)(7)(B) of the Act, and include such measures as the quality measures selected for reporti ng under the PQRS. In accordance with section 1890A(a)(1) of the Act, the NQF convened multi- stakeholder groups by creating the Measure Applications Partnership (MAP). Section 1890A(a)(2) of the Act requires that the Secretary must makeCMS-1612-FC 712

publicly available by December 1st of each year a lis t of the quality and efficiency measures that the Secretary is considering for selection through rulemaking for use in the Medicare program. The NQF must provide CMS with the MAP’s input on the selection of measures by February 1st of each year. The

lists of measures under consideration for selecti on through rulemaking in 2014 are available at http://www.qualityforum.org/map/

. As we noted above, section 1848(k)(2)(C)(ii) of the Act provides an exception to the requirement that the Secretary select 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 entity, as long as due consideration is given to measures that have been endorsed or adopted by a consensus organization identified by the Secretary. Under this exception, aside from NQF endorsement, we requested that stakeholders appl y the following considerations wh en submitting measures for possible inclusion in the PQRS measure set:

● Measures that are not duplicative of another existing or proposed measure.

● Measures that are further along in de velopment than a measure concept.

● CMS is not accepting claims-based-only reporting measures in this process.

● Measures that are outcome-based are pr eferred to clinical process measures.

● Measures that address patient safety and adverse events.

● Measures that identify appropriate use of diagnosis and therapeutics.

● Measures that identify care coordination and communication.

● Measures that identify care coordination of pa tient experience and patient-reported outcomes.

● Measures that address efficiency, cost and resource use. As a general matter, please note that the measure tabl es contained in this section III.K. may also contain discussions of comments we received related to prop osed changes to the measu res included in the quality performance standard under the Shared Savings Program. a. PQRS Quality MeasuresCMS-1612-FC 713

Taking into consideration the statutory and non-st atutory criteria we described previously, this section contains our responses to our proposals related to the measures in the PQRS for 2015 and beyond. We classified all measures against six domain s based on the NQS’s six priorities, as follows: (1) Patient Safety

. These measures reflect the safe delivery of clinical services in all healthcare settings. These measures may address a structure or pro cess that is designed to reduce risk in the delivery

of healthcare or measure the occurrence of an untoward outcome such as adverse events and complications of procedures or other interventions. (2) Person and Caregiver-Centered Experience a nd Outcomes. These are measures that reflect the potential to improve patient-centered care and th e quality of care delivered to patients. They emphasize the importance of collecting patient-repor ted data and the ability to impact care at the individual patient level, as well as the population leve l. These are measures of organizational structures or processes that foster both the inclusion of persons and family members as active members of the health care team and collaborative partnershi ps with providers and provider organizations or can be measures of patient-reported experiences and outcomes that reflect greater involvement of patients and families in decision making, self-care, activation, and understa nding of their health condition and its effective management. (3) Communication and care coordination

. These measures demonstrate appropriate and timely sharing of information and coordination of clinical and preventive services among health professionals in the care team and with patients, caregivers, and fa milies to improve appropria te and timely patient and care team communication. They may also be measur es that reflect outcomes of successful coordination

of care. (4) Effective clinical care

. These are measures that reflect clin ical care processes closely linked to outcomes based on evidence and practice guidelin es or measures of patient-centered outcomes of

disease states. (5) Community/population health

. These measures reflect the use of clinical and preventive services and achieve improvements in the health of the population served. They may be measures ofCMS-1612-FC 714

processes focused on primary prevention of disease or general screening for early detection of disease unrelated to a current or prior condition-. (6) Efficiency and cost reduction

. These measures reflect efforts to lower costs and to significantly improve outcomes and reduce errors. These are measures of cost, resource use and appropriate use of healthcare resources or inefficiencies in healthcare delivery. Please note that the PQRS quality measure specifica tions for any given PQ RS individual quality measure may differ from specifications for the same qua lity measure used in prior years. For example, for the PQRS quality measures that were selected for reporting in 2014 and beyond, please note that detailed measure specifications, including the measure ’s title, for the individual PQRS quality measures 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 measu re titles with the measure titles that have been finalized for 2013, 2014, 2015, and potentially subsequent years of the EHR Incentive Program for Eligible Professionals, we note that the measure titles for measures available for reporting via EHR may change. To the extent that the EHR Incentive Pr ogram for Eligible Professionals updates its measure titles to include version numbers (77 FR 13744), we w ill use these version numbers to describe the PQRS

EHR measures that will also be available for re porting for the EHR Incentive Program for Eligible

Professionals. We will continue to work toward co mplete 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 substant ively change the nature of the measure. Examples of such changes could be updated diagnosis or proce dure codes or changes to exclusions to the patient population or definitions. We believe these types of maintenance changes are di stinct from substantive changes to measures that result in wh at are considered new or different measures. Further, we believe that non-substantive maintenance changes of this type do not trigger the same agency obligations under

the Administrative Procedure Act.CMS-1612-FC 715

In the CY 2013 PFS final rule with comment period, we finalized our proposal providing that if the NQF updates an endorsed measure that we have a dopted for the PQRS in a manner that we consider to not substantively change the nature of the measure, we would use a subregulatory process to incorporate those updates to the measure specifications that apply to the program (77 FR 69207). We believe this adequately balances our need to in corporate non-substantive NQF updates to NQF-endorsed measures in the most expeditious manner possible, while preserving the public’s ability to comment on updates that so fundamentally change an endorsed meas ure that it is no longer the same measure that we originally adopted. We also noted that the NQF process incorporates an opportunity for public comment and engagement in the measure maintenance process. We will revise the Specifications Manual and post notices to clearly identify the updates and provide lin ks to where additional information on the updates can be found. Updates will also be available on the CMS PQRS website at http://www.cms.gov/Medicare/Quality-Initiatives-Pa tient-Assessment-Instruments/PQRS/index.html

. CMS is not the measure steward for most of the measures available for reporting under the PQRS. We rely on outside measure stewards and devel opers to maintain these measures. In Table 55, we proposed that certain measures be removed from the PQRS measure set due to the measure owner/developer indicating that it will not be able to ma intain the measure. We noted that this proposal is contingent upon the measure owner/de veloper not being able to maintain the measure. Should we learn that a certain measure owner/developer is able to main tain the measure, or that another entity is able to

maintain the measure in a manner that allows the measure to be available for reporting under the PQRS for the CY 2017 PQRS payment adjustment, we propo sed to keep the measure available for reporting under the PQRS and therefore not finalize our proposal to remove the measure. In addition, if, after the display of this final rule with comment period, we discover additional measures within the current PQRS measure set that a measure owner/developer can no longer maintain, we proposed to remove these measures from reporting for the PQRS beginning in 2015. We will discuss any such instances in the PQRS measure tables below. In addition, we noted that we have received f eedback from stakeholders, particularly first-time participants who find it difficult to understand which me asures are applicable to their particular practice.CMS-1612-FC 716

In an effort to aid eligible professionals and gro up practices to determine what measures best fit their practice, and in collaboration with specialty socie ties, we are beginning to group our final measures available for reporting according to specialty. The cu rrent listing of our measures by specialty can be

found on our website at http://www.cms.gov/Medicare/Quality-Initiatives-Patient-AssessmentInstruments/PQRS/index.html . Please note that these groups of me asures are meant to provide guidance to those eligible professionals seeking to determine wh at measures to report. Eligible professionals are not required to report measures according to these sugg ested groups of measures. In addition to group measures according to specialty, we also plan to ha ve a measure subset for measures that specifically addresses multiple chronic conditions. As measures are adopted or revised, we will continue to update these groups to reflect the measures available under the PQRS, as well as add more specialties. In the CY 2014 PFS final rule with comment pe riod, we stated that “unless there are errors discovered in updated electronic measure specifications, the PQRS intends to use the most recent, updated versions of electronically specified clinical quality measures for that year” (78 FR 74489). We proposed that, if we discovered errors in the most recently up dated electronic measure specifications for a certain measure, we would use the version of electronic measure specifications that immediately precedes the most recently updated electronic measure specifications. Any such change to a measure is also described in the PQRS measure tables below. Additionally, we noted that, with respect to the following e-measure CMS140v2, Breast Cancer Hormonal Therapy for Stage IC–IIIC Estrogen Recept or/Progesterone Receptor (ER/PR) Positive Breast Cancer (NQF 0387), a substantive error was discovere d in the June 2013 version of this electronically specified clinical quality measure. Therefore, the PQRS required the use of the prior, December 2012 version of this measure, which is CMS140v1 (78 FR 74489). Please note that, consistent with other EHR measures, since a more recent and corrected version of this measure has been developed, we will require the reporting of the most recent, updated versions of the measure Breast Cancer Hormonal Therapy for Stage IC–IIIC Estrogen Receptor/Progesterone Recepto r (ER/PR) Positive Breast Cancer (NQF 0387) – currently version CMS140v3 – for the year. b. Cross-Cutting Measure Set for 2015 and BeyondCMS-1612-FC 717

In accordance with our criteria for the satisf actory reporting of PQRS measures for the 2017 PQRS payment adjustment via claims and registry that requires an eligible professional or group practice to report on at least 2 cross-cutting measures, we pr oposed 18 cross-cutting measure set specified in Table 21 in the CY 2015 PFS proposed rule for 2015 and beyond (79 FR 40404). Please note that we are finalizing all measures as proposed (see Table 52). We are also adding a measure to the list of crosscutting measures, based on comments that were submitted. Please note that our response and final

decision for each of these measures is found in Table 52. We have also indicated the PQRS reporting

mechanism or mechanisms through which each measure could be submitted. Please note that we are changing some of the reporting mechanisms availabl e for certain cross-cutting measures in Table 52 from the reporting options we proposed would be availabl e in the CY 2015 PFS proposed rule (79 FR 40404). To the extent that changes to th e reporting mechanisms for the cross-cutting measures specified in Table 52 were made from what was specified in the proposed rule, we provide the explanation and rationale for those changes in Table 53. The following are high-level comments regardi ng our proposals related to the proposed crosscutting measure set: Comment: Several commenters supported th e development of a cross-cutting measure set as well as the composition as proposed, wh ile other commenters were concerned about this new requirement noting the measures may not be as applicable to some specialists. Response: With respect to the commenter s who expressed concern that the proposed measures in the proposed cross-cutting measures set did not apply to many specialties, we note that limitations such as only requ iring reporting of a cross-cutti ng measures in a face-to-face encounter would exclude those elig ible professionals for which the measures do not apply. With respect to taking a more phased-in approach to introducing the cro ss-cutting measure set, please note that we have modified this proposal to only require the reporting of 1 cross-cutting measure. We believe that requiring the re porting of 1 measure in the cro ss-cutting measures set is not overly burdensome and may help eligible profe ssionals by providing direction on what measuresCMS-1612-FC 718

to report. We are modifying our proposal to only require eligible professi onals who see at least 1 Medicare patient in a face-to-face encounter to report on 1 cross-cutting measure. TABLE 52: Individual Quality Cross-Cutting Me asures for the PQRS to Be Available for Satisfactory Reporting Via Claims, Registry, and EHR Beginning in 2015NQF/PQRSCMSE-Measure ID NQS Domain Measure Title and Description ¥MeasureStewardClaimsCSVRegistryEHRGPRO (WebInterface)Measures GroupsOther QualityReportingPrograms

Measures Finalized as Propos ed or with Modifications

N/A /402 N/ A Communit y/Populati on Health Tobacco Use and Help with Quitting Among Adolescents: The percentage of adolescents 12 to 20 years of age with a primary care visit during the measurement year for whom tobacco use status was documented and received help with quitting if identified as a tobacco user Commenters agreed this measure was appropriately classified as cross-cutting. For this reason, CMS is finalizing its proposal to make this measure reportable as a cross-cutting measure for 2015 PQRS. NCQA / NCIQM X X

N/A/ 400 N/ A Effective Clinical

Care Hepatitis C: One-Time Screening for Hepatitis C Virus (HCV) for Patients at Risk: Percentage of patients aged 18 years and older with one or more of the following: a history of injection drug use, receipt of a blood transfusion prior to 1992, receiving maintenance hemodialysis OR birthdate in the years 1945-1965 who received a one-time screening for HCV infection Commenters agreed this measure was appropriately classified as cross-cutting. For this reason, CMS is finalizing its proposal to make this measure reportable as a cross-cutting measure for 2015 PQRS. AGA / AASLD /

AMAPCPI X

0097 /046 N/ A Communi cation and Care Coordinati on Medication Reconciliation: Percentage of patients aged 18 years and older discharged from any inpatient facility (for example, hospital, ski lled nursing facility, or rehabilitation facility) and seen within 30 days following discharge in the office by the physician, prescribing practitioner, registered nurse, or clinical pharmacist providing on-going care who had a reconciliation of the discharge medications with the current medication list in the outpatient medical record documented This measure is reported as two rates NCQA/AMAPCPI X XCMS-1612-FC 719NQF/PQRSCMSE-Measure ID NQS Domain Measure Title and Description ¥MeasureStewardClaimsCSVRegistryEHRGPRO (WebInterface)Measures GroupsOther QualityReportingPrograms

stratified by age group: Reporting Age Criteria 1: 18-64 years of age Reporting Age Criteria 2: 65 years and older. Commenters supported the inclusion of this measure as cross cutting “due to its focus on critical care coordination transitions between hospitals and ambulatory care providers.” As such, CMS is finalizing its proposal to make this measure reportable as a cross-cutting measure for 2015 PQRS. We note that while the proposed rule limited the applicability of this measure to patients 65 years and older, the range of this mesaure was changed to include patients 18-64 years of age by the measure steward. This meas ure update is endorsed by NQF.

0326 /047 N/ A Communi cation and Care Coordinati on Care Plan: Percentage of patients aged 65 years and older who have an advance care plan or surrogate decision maker documented in the medical record or documentation in the medical record that an advance care plan was discussed but the patient did not wish or was not able to name a surrogate decision maker or provide an advance care plan Commenters agreed this measure was appropriately classified as cross-cutting. For this reason, CMS is finalizing its proposal to make this measure reportable as a cross-cutting measure for 2015 PQRS. NCQA/AMAPCPI X X X

0041 /110 147 v4 Communit y/Populati on Health Preventive Care and Screening: Influenza Immunization: Percentage of patients aged 6 months and older seen for a visit between October 1 and March 31 who received an influenza immunization OR who reported previous receipt of an influenza immunization Commenters agreed this measure was appropriately classified as cross-cutting. For this reason, CMS is finalizing its proposal to make this measure reportable as a cross-cutting measure for 2015 PQRS. AMAPCPI X X X X X ACO MU2

0043 /111 127 v3 Communit y/Populati on Health Pneumonia Vaccination Status for Older Adults: Percentage of patients 65 years of age and older who have ever received a pneumococcal vaccine NCQA X X X X X ACO MU2CMS-1612-FC 720NQF/PQRSCMSE-Measure ID NQS Domain Measure Title and Description ¥MeasureStewardClaimsCSVRegistryEHRGPRO (WebInterface)Measures GroupsOther QualityReportingPrograms

Commenters agreed this measure was appropriately classified as cross-cutting. For this reason, CMS is finalizing its proposal to make this measure reportable as a cross-cutting measure for 2015 PQRS.

0421 /128 69v 3 Communit y/Populati on Health Preventive Care and Screening: Body Mass Index (BMI) Screening and Follow-Up Plan: Percentage of patients aged 18 years and older with a BMI documented during the current encounter or during the previous six months AND with a BMI outside of normal parameters, a follow-up plan is documented during the encounter or during the previous six months of the current encounter Normal Parameters: Age 65 years and older BMI ≥ 23 and < 30 kg/m 2 ; Age 18- 64 years BMI ≥ 18.5 and < 25 kg/m 2 Commenters agreed this measure was appropriately classified as cross-cutting. For this reason, CMS is finalizing its proposal to make this measure reportable as a cross-cutting measure for 2015 PQRS. CMS/QIP X X X X X ACO MU2

0419 /130 68v 4 Patient Safety Documentation of Current Medications in the Medical Record: Percentage of visits for patients aged 18 years and older for which the eligible professional attests to documenting a list of current medications using all immediate resources available on the date of the encounter. This list must include ALL known prescriptions, over-the-counters, herbals, and vitamin/mineral/dietary (nutritional) supplements AND must contain the medicati ons’ name, dosage, frequency and route of administration Commenters agreed this measure was appropriately classified as cross-cutting. For this reason, CMS is finalizing its proposal to make this measure reportable as a cross-cutting measure for 2015 PQRS. CMS/QIP X X X X X ACO MU2

0420 /131 N/ A Communi cation and Care Coordinati on Pain Assessment and Follow-Up: Percentage of visits for patients aged 18 years and older with documentation of a pain assessment using a standardized tool(s) on each visit AND documentation of a follow-up plan when pain is present No comments were received regardingthis measure being classified as crosscutting. CMS is finalizing its proposal to CMS/QIP X X XCMS-1612-FC 721NQF/PQRSCMSE-Measure ID NQS Domain Measure Title and Description ¥MeasureStewardClaimsCSVRegistryEHRGPRO (WebInterface)Measures GroupsOther QualityReportingPrograms

make this measure reportable as a crosscutting measure for 2015 PQRS.

0418 /134 2v4 Communit y/Populati on Health Preventive Care and Screening: Screening for Clinical Depression and Follow-Up Plan: Percentage of patients aged 12 years and older screened for clinical depression on the date of the encounter using an age appropriate standardized depression screening tool AND if positive, a follow-up plan is documented on the date of the positive screen Commenters agreed this measure was appropriately classified as cross-cutting. For this reason, CMS is finalizing its proposal to make this measure reportable as a cross-cutting measure for 2015 PQRS. CMS/QIP X X X X X ACO MU2

N/A /182 N/ A Communi cation and Care Coordinati on Functional Outcome Assessment: Percentage of visits for patients aged 18 years and older with documentation of a current functional outcome assessment using a standardized functional outcome assessment tool on the date of encounter AND documentation of a care plan based on identified functional outcome deficiencies on the date of the identified deficiencies No comments were received regardingthis measure being classified as crosscutting. CMS is finalizing its proposal tomake this measure reportable as a crosscutting measure for 2015 PQRS. CMS/QIP X X

0028 /226 138 v3 Communit y/Populati on 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 Commenters agreed this measure was appropriately classified as cross-cutting. For this reason, CMS is finalizing its proposal to make this measure reportable as a cross-cutting measure for 2015 PQRS. AMAPCPI X X X X X ACO MU2 Million HeartsCMS-1612-FC 722NQF/PQRSCMSE-Measure ID NQS Domain Measure Title and Description ¥MeasureStewardClaimsCSVRegistryEHRGPRO (WebInterface)Measures GroupsOther QualityReportingPrograms

0018 /236 165 v3 Effective Clinical

Care Controlling High Blood Pressure: Percentage of patients 18-85 years of age who had a diagnosis of hypertension and whose blood pressure was adequately controlled (<140/90 mmHg) during the measurement period Commenters agreed this measure was appropriately classified as cross-cutting. For this reason, CMS is finalizing its proposal to make this measure reportable as a cross-cutting measure for 2015 PQRS. This measure was part of the cardiovascular prevention and ischemic vascular disease measures group. Therefore, the details and rationale regarding the changes we are making to this measure can be found in our discussion of the cardiovascular prevention and ischemic vascular disease measures group in sec tion III.K.5.d of this final rule. NCQA X X X X ACO MU2 Million Hearts

0038 /240 117 v3 Communit y/Populati on Health Childhood Immunization Status: Percentage of children 2 years of age who had four diphtheria, tetanus and acellular pertussis (DTaP); three polio (IPV), one measles, mumps and rubella (MMR); three H influenza type B (HiB); three hepatitis B (Hep B); one chicken pox (VZV); four pneumococcal conjugate (PCV); one hepatitis A (Hep A); two or three rotavirus (RV); and two influenza (flu) vaccines by their second birthday Commenters agreed this measure was appropriately classified as cross-cutting. For this reason, CMS is finalizing its proposal to make this measure reportable as a cross-cutting measure for 2015 PQRS. NCQA X MU2

N/A /317 22v 3 Communit y/Populati on Health Preventive Care and Screening: Screening for High Blood Pressure and Follow-Up Documented: Percentage of patients aged 18 years and older seen during the reporting period who were screened for high blood pressure (BP) AND a recommended follo w-up plan is documented based on the current blood pressure reading as indicated Commenters agreed this measure was appropriately classified as cross-cutting. For this reason, CMS is finalizing its proposal to make this measure reportable as a cross-cutting measure for 2015 PQRS. CMS/QIP X X X X X ACO MU2 Million HeartsCMS-1612-FC 723NQF/PQRSCMSE-Measure ID NQS Domain Measure Title and Description ¥MeasureStewardClaimsCSVRegistryEHRGPRO (WebInterface)Measures GroupsOther QualityReportingPrograms

0101 /318 139 v3 Patient Safety Falls: Screening for Fall Risk: Percentage of patients 65 years of age and older who were screened for future fall risk at least once during the measurement period Commenters agreed this measure was appropriately classified as cross-cutting. For this reason, CMS is finalizing its proposal to make this measure reportable as a cross-cutting measure for 2015 PQRS. NCQA X X ACO MU2

0005 &00 06 /321 N/ A Person and Caregiver Experienc

e and Outcomes CAHPS for PQRS Clinician/Group Survey: • Getting timely care, appointments, and information; • How well providers Communicate; • Patient’s Rating of Provider; • Access to Specialists; • Health Promotion & Education; • Shared Decision Making; • Health Status/Functional Status; • Courteous and Helpful Office Staff; • Care Coordination; • Between Visit Communication; • Helping Your to Take Medication as Directed; and • Stewardship of Patient Resources No comments were received regardingthis measure being classified as crosscutting. CMS is finalizing its proposal tomake this measure reportable as a crosscutting measure for 2015 PQRS. AHRQ X ACO

N/A /374 50v 3 Communi cation and 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 No comments were received regardingthis measure being classified as crosscutting. CMS is finalizing its proposal tomake this measure reportable as a crosscutting measure for 2015 PQRS. CMS/BA H X MU2

Additional Measures Finalized in Response to Public Comment

0059 /001 122 v3 Effective Clinical

Care Diabetes: Hemoglobin A1c Poor Control: Percentage of patients 18-75 years of age with diabetes who had hemoglobin A1c > 9.0% during the measurement period This measure was not proposed for the cross-cutting measure set for 2015 and beyond. However, in addition to seeking comment on the proposed cross-cutting NCQA X X X X X ACO MU2CMS-1612-FC 724NQF/PQRSCMSE-Measure ID NQS Domain Measure Title and Description ¥MeasureStewardClaimsCSVRegistryEHRGPRO (WebInterface)Measures GroupsOther QualityReportingPrograms

measure set specified in Table 21 of the proposed rule, we sought comment on other measures that commenters believedshould be included in that proposed crosscutting measure set for 2015 and beyond (79 FR 40403). Commenters suggested that CMS “include a diabetes-related measure such as NQF 0059 "Hemoglobin Al C Poor Control" or other diabetes measure in the cross-cutting measure set for reporting under PQRS” as it is a measure that most eligible professionals can report. CMS agrees and is, therefore, finalizing the addition of PQRS #001 to the cross-cutting measure set for 2015 PQRS. CMS may consider additional measures for the cross-cutting measure set in future program years. ¥ Measure details including titles, descriptions and meas ure owner information may vary during a particular program year. This is due to the timi ng of measure specification preparation and the measure versions used by the various reporting options/methods. Please refer to the meas ure specifications that apply for each of the reporting options/methods for specific measure details. c. New PQRS Measures Available for Reporting for 2015 and Beyond Table 22 in the CY 2015 PFS proposed rule (79 FR 40410) contained the additional measures we proposed to include in the PQRS measure set for CY 2015 and beyond. In Table 53, we provide our response to the comments we received on these measur es as well as our final decisions on these proposed measures. We have also indicated the PQRS re porting mechanism or mechanisms through which each measure could be submitted. As stated above, pl ease note that the following tables may also contain discussions of comments we received related to prop osed changes to the measu res included in the quality performance standard under the Shared Savings Program.CMS-1612-FC 725

TABLE 53: New Individual Quality Measures and Those Included in Measures Groups for the PQRS to Be Available for Satisfactory Reporting Beginning in 2015NQF/PQRSCMSE-Measure ID NQS Domain Measure Title and Description ¥Measure StewardClaimsCSVRegistryEHRGPRO (WebInterface)Measures GroupsOther QualityReportingPrograms

Measures Finalized as Propos ed or with Modifications

187 9 /38 3 N/ A Patient Safety Adherence to Antipsychotic Medications for Individuals with Schizophrenia: The percentage of individuals 18 years of age or greater as of the beginning of the measurement period with schizophrenia or schizoaffective disorder who are prescribed an antipsychotic medication, with adherence to the antipsychotic medication [defined as a Proportion of Days Covered (PDC)] of at least 0.8 during the measurement period (12 consecutive months) Commenters supported the inclusion of this measure in PQRS but request this measure also be reportable through claims. Although CMS understands commenters’ concern regarding reporting via registry only, we have determined that the complexity of the measure warrants reportability only through the registry reporting option. For this reason, CMS is finalizing this measure to be reportable beginning in 2015 for PQRS. CMS / FMQAI X

N/ A /38 4 N/ A Effective Clinical

Care Adult Primary Rhegmatogenous Retinal Detachment Repair Success Rate: Percentage of surgeries for primary rhegmatogenous retinal detachment where the retina remains attached after only one surgery CMS received no comments on this measure. This is an outcome-based measure that addresses a new clinical concept not currently captured within PQRS and targets a specialty provider group, ophthalmologist, who are often underrepresented in the PQRS program. As such, this measure provides meaningful value for the PQRS program. For these reasons, CMS is finalizi ng its proposal to make this measure reportable beginning in 2015 for PQRS. American Associatio n of Eye and Ear Centers of Excellenc e X

N/ A /38 5 N/ A Effective Clinical

Care Adult Primary Rhegmatogenous Retinal Detachment Surgery Success Rate: Percentage of retinal detachment casesachieving flat retinas six months postsurgery Commenters disagreed with CMS’s proposal to include th is measure in PQRS, noting the measure has not been broadly American Associatio n of Eye and Ear Centers of Excellenc

e/ The Australian

Council XCMS-1612-FC 726NQF/PQRSCMSE-Measure ID NQS Domain Measure Title and Description ¥Measure StewardClaimsCSVRegistryEHRGPRO (WebInterface)Measures GroupsOther QualityReportingPrograms

tested and possible unintended consequences that may drive physicians to perform retinal detachment surgeries in the hospital setting. This is an outcome-based measure that addresses a new clinical concept not currently captured within PQRS and targets a specialty provider group, ophthalmologists, who are often underrepresented in the PQRS program. Furthermore, the steward confirmed the setting of service is not relevant as a negative consequence of this measure. CMS agrees with this assessment that the setting of care is not an unintended consequence that woul d negatively impact the patient if this surgery were conducted in a hospital and believes this measure provides meaningful value for the PQRS program. For these reasons, CMS is finalizing its proposal to make this measure reportable beginning in 2015 for PQRS. on Healthcar e Standards

N/ A /38 6 N/ A Person andCaregiverCentered Experience and Outcomes Amyotrophic Lateral Sclerosis (ALS) Patient Care Preferences: Percentage of patients diagnosed with Amyotrophic Lateral Sclerosis (ALS ) who were offered assistance in planning for end of life issues (for example, advance directives, invasive ventilation, hospice) at least once annually No comments were received regarding this measure being a dded to PQRS. CMS is finalizing its proposal to make this measure reportable beginning in 2015 for PQRS. AAN X

N/ A /38 7 N/ A Effective Clinical

Care Annual Hepatitis C Virus (HCV) Screening for Patients who are Active Injection Drug Users: Percentage of patients regardless of age who are active injection drug users who received screening for HCV infection within the 12 month reporting period Although one commenter requested this measure be adjusted to include more than “injection drug use,” citing its limiting risk factor, several commenters supported the inclusion of this measure in PQRS. Injection drug use has been associated as a high risk factor for HCV. Therefore, CMS is finalizing its propos al to make this measure reportable beginning in 2015 for PQRS. AGA / AASLD /

PCPI X

N/ A /38

8 N/ A Patient Safety Cataract Surgery with Intra-Operative Complications (Unplanned Rupture of Posterior Capsule Requiring Unplanned Vsitrectomy): Rupture of the posterior capsule during anterior segment surgery AAEECE / ACHS X XCMS-1612-FC 727NQF/PQRSCMSE-Measure ID NQS Domain Measure Title and Description ¥Measure StewardClaimsCSVRegistryEHRGPRO (WebInterface)Measures GroupsOther QualityReportingPrograms

requiring vsitrectomy Several commenters submitted positive comments about the inclusion of this measure in the PQRS program and requested that CMS make this measure reportable via claims. In addition, there were commenters that encouraged CMS to “test this measure before implementation.” Commenters did not specify the type of testing. This measure, per the guidelines of quality measure inclusion required for the PQRS program, has been tested by the steward. Furthermore, this is an outcome measure that complements the existing cataracts measures with a clinical focus not currently captured within PQRS. For these reasons, CMS is finalizi ng its proposal to make this measure reportable beginning in 2015 for PQRS for registry and measure group reporting only. CMS is moving away from claims-based reporting and as such is not finalizing this measure for claims reporting in 2015 PQRS.

N/ A /38 9 N/ A Effective Clinical

Care Cataract Surgery: Difference Between Planned and Final Refraction: Percentage of patients who achieve planned refraction within +-1,0 D Several commenters submitted positive comments about the inclusion of this measure in the PQRS program and requested that CMS make this measure reportable via claims. In addition, there were commenters that encouraged CMS to test this measure before implementation. Commenters did not specify the type of testing. This measure, per the guidelines of quality measure inclusion in the PQRS program, has been tested by the steward. Furthermore, this is an outcome measure that complements the existing cataracts measures with a clinical focus not currently captured within PQRS. For these reasons, CMS is finalizing its proposal to make this measure reportable beginning in 2015 for PQRS for registry and measure group reporting only. CMS is moving away from the claims reporting option and as such is not finalizing this measure as reportable for claims in 2015 PQRS. AAEECE / ACHS X X

N/ A /39 0 N/ A Person andCaregiverCentered Experience and Discussion and Shared Decision Making Surrounding Treatment Options: Percentage of patients aged 18 years and older with a diagnosis of hepatitis C with whom a physician or other qualified AGA / AASLD /

PCPI X XCMS-1612-FC 728NQF/PQRSCMSE-Measure ID NQS Domain Measure Title and Description ¥Measure StewardClaimsCSVRegistryEHRGPRO (WebInterface)Measures GroupsOther QualityReportingPrograms

Outcomes healthcare professional reviewed the range of treatment options appropriate to their genotype and demonstrated a shared decision making approach with the patient. To meet the measure, there must be documentation in the patient record of a discussion between the physician or other qualified healthcare professional and the patient that includes all of the following: treatment choices appr opriate to genotype, risks and benefits, evidence of effectiveness, and patient preferences toward treatment Some commenters expressed concern that this measure might incentivize providers not to treat patients, indicating a provider might “simply note “t he patient expressed reservations about potential side effects and we decided to defer treatment,” rather than working with the patient to address concerns and optimize uptake of the appropriate care.” However, CMS feels strongly that patients need to be provided appropriate information that would help patients to make their decision on treatment options. This measure focuses on discussion and shared decision making on treatment options. For these reasons, CMS is finalizing its propos al to include this measure for registry and measure group reporting in 2015 PQRS.

N/ A /39

1 N/ A Communica tion and

Care Coordinatio n Follow-up After Hospitalization for Mental Illness (FUH): The percentage of discharges for patients 6 years of age and older who were hospitalized for treatment of selected mental illness diagnoses and who had an outpatient visit, an intensive outpatient encounter or partial hospitalization with a mental health practitioner. Two rates are reported: - The percentage of discharges for which the patient received follow-up within 30 days of discharge - The percentage of discharges for which the patient received follow-up within 7 days of discharge Commenters supported the inclusion of this measure in PQRS but request this measure also be reportable thr ough claims. It is a priority for PQRS to ultimately increase the quality of health care. In order to achieve this goal, PQRS need s reliable and robustdata on health service delivery and claimsbased reporting has demonstrated, over NCQA XCMS-1612-FC 729NQF/PQRSCMSE-Measure ID NQS Domain Measure Title and Description ¥Measure StewardClaimsCSVRegistryEHRGPRO (WebInterface)Measures GroupsOther QualityReportingPrograms

several years, the highest error rate among the PQRS reporting options. For this reason, CMS is finalizi ng its proposal to make this measure reportable beginning in 2015 for PQRS for registry reporting only.

N/ A /39 2 N/ A Patient Safety HRS-12: Cardiac Tamponade and/or Pericardiocentesis Following Atrial Fibrillation Ablation: Rate of cardiac tamponade and/or pericardiocentesis following atrial fibrillation ablation Commenters supported the inclusion of this measure in PQRS. For this reason, CMS is finalizing its proposal to make this measure reportable beginning in 2015 for PQRS. HRS X

N/ A /39 3 N/ A Patient Safety HRS-9: Infection within 180 Days of Cardiac Implantable Electronic Device (CIED) Implantation, Replacement, or Revision: Infection rate following CIED device implantation, replacement, or revision Commenters supported the inclusion of this measure in PQRS. For this reason, CMS is finalizing its proposal to make this measure reportable beginning in 2015 for PQRS. HRS X

140 7 /39 4 N/ A Community/ Population

Health Immunizations for Adolescents: The percentage of adolescents 13 years of age who had the recommended immunizations by their 13th birthday Commenters supported the inclusion of this measure in PQRS. For this reason, CMS is finalizing its proposal to make this measure reportable beginning in 2015 for PQRS. NCQA X

N/ A /39 5 N/ A Communica tion and

Care Coordinatio n Lung Cancer Reporting (Biopsy/Cytology Specimens): Pathology reports based on biopsy and/or cytology specimens with a di agnosis of primary nonsmall cell lung cancer classified into specific histologic type or classified as NSCLC-NOS with an explanation included in the pathology report Commenters supported the inclusion of this measure in PQRS. For this reason, CMS is finalizing its proposal to make this measure reportable beginning in 2015 for PQRS. CAP X X

N/ A /39 6 N/ A Communica tion and

Care Coordinatio n Lung Cancer Reporting (Resection Specimens): Pathology reports based on resection specimens with a diagnosis of primary lung carcinoma that include the pT category, pN category and for non-small cell lung cancer, histologic type Commenters supported the inclusion of this CAP X XCMS-1612-FC 730NQF/PQRSCMSE-Measure ID NQS Domain Measure Title and Description ¥Measure StewardClaimsCSVRegistryEHRGPRO (WebInterface)Measures GroupsOther QualityReportingPrograms

measure in PQRS. For this reason, CMS is finalizing its proposal to make this measure reportable beginning in 2015 for PQRS.

N/ A /39 7 N/ A Communica tion and

Care Coordinatio n Melanoma Reporting: Pathology reports for primary malignant cutaneous melanoma that include the pT category and a statement on thickness and ulceration and for pT1, mitotic rate Commenters supported the inclusion of this measure in PQRS. For this reason, CMS is finalizing its proposal to make this measure reportable beginning in 2015 for PQRS. CAP X X

N/ A /39

8 N/ A Effective Clinical

Care Optimal Asthma Control: Patients ages 5- 50 (pediatrics ages 5-17) whose asthma is well-controlled as demonstrated by one of three age appropriate patient reported outcome tools

Several commenters di sagreed with CMS’s proposal to repla ce existing measure (PQRS #064 “Asthma: Assessment of Asthma Control – Ambulatory Care Setting”) with this new measure. Details regarding commenters concerns with removing PQRS #064 can be found in Table 56. Although CMS understands the limitations of the current measure as it relates to the upper age limit, risk adjustment and the calculation of improvement over time, this measure represents a more r obust clinical outcome for asthma care. For this reason, CMS is finalizing its proposal to make this measure reportable beginning in 2015 for PQRS for registry only. In addition, CMS re-evaluated the categorization of this measure to the Person and Caregiver Experience and Outcomes domain and determined it was more appropriately categorized under Effective Clinical Care. As such, CMS is finalizing this measure under Effective Clinical Care for 2015 PQRS program. MNCM X

N/ A /39 9 N/ A Effective Clinical

Care Post-Procedural Optimal Medical Therapy Composite (Percutaneous Coronary Intervention): Percentage of patients aged 18 years and older for whom PCI is performed who are prescribed optimal medical therapy at discharge Commenters supported the inclusion of this measure in PQRS. For this reason, CMS is finalizing its proposal to make this measure reportable beginning in 2015 for PQRS. ACCAHA XCMS-1612-FC 731NQF/PQRSCMSE-Measure ID NQS Domain Measure Title and Description ¥Measure StewardClaimsCSVRegistryEHRGPRO (WebInterface)Measures GroupsOther QualityReportingPrograms

N/ A/ /40 0 N/ A Effective Clinical

Care Hepatitis C: One-Time Screening for Hepatitis C Virus (HCV) for Patients at Risk: Percentage of patients aged 18 years and older with one or more of the following: a history of injection drug use, receipt of a blood transfusion prior to 1992, receiving maintenanc e hemodialysis OR birthdate in the years 1945-1965 who received a one-time screening for HCV infection Although one commenter requested this measure be adjusted to include more than “injection drug use,” citing its limiting risk factor, injection drug use has been associated as a high-risk factor for HCV. Additionally, the commenter suggested that this measure include “risk groups” to encompass men who have sex with men (MSM). Transmission of HCV by sex is low and does not necessitate routine screening. Furthermore, several commenters supported the inclusion of this measure in PQRS. CMS received public comment from the measure steward indicating this measure should be classified under the domain of Ef fective Clinical Care. After further review, CMS determined this measure was more appropriately categorized under the Effective Clinical Care domain based on the HHS decision rule guidelines for categorizing measures. For these reasons, CMS is finalizing its proposal to make this measure reportable beginning in 2015 for PQRS. AGA / AASLD /

AMAPCPI X

N/ A /40

1 N/ A Effective Clinical

Care Screening for Hepatocellular Carcinoma (HCC) in patients with Hepatitis C Cirrhosis: Percentage of patients aged 18 years and older with a diagnosis of chronic hepatitis C cirrhosis who underwent imaging with either ultrasound, contrast enhanced CT or MRI for hepatocellular carcinoma (HCC) at least once within the 12 month reporting period Commenters supported the inclusion of this measure in PQRS, but also suggested CMS refine the measure language to include other risk groups and diagnosis. We appreciate the commenters’ support for this measure. With respect to the measure language, we note that we have decided not to make changes to this measure in order to maintain consistency with the specifications maintained by the measure AGA / AASLD /

AMAPCPI X XCMS-1612-FC 732NQF/PQRSCMSE-Measure ID NQS Domain Measure Title and Description ¥Measure StewardClaimsCSVRegistryEHRGPRO (WebInterface)Measures GroupsOther QualityReportingPrograms

developper and owner. Based on the comments received, CMS is finalizing its proposal to make this measure reportable beginning in 2015 for PQRS.

N/ A /40 2 N/ A Community/ Population

Health Tobacco Use and Help with Quitting Among Adolescents: The percentage of adolescents 12 to 20 years of age with a primary care visit during the measurement year for whom tobacco use status was documented and received help with quitting if identified as a tobacco user Commenters supported the inclusion of this measure in PQRS. For this reason, CMS is finalizing its proposal to make this measure reportable beginning in 2015 for PQRS. NCQA / NCIQM X X

Measures Not Finalized as Proposed

188 0 /N/ A N/ A Patient Safety Adherence to Mood Stabilizers for Individuals with Bipolar I Disorder: The measure calculates the percentage of individuals aged 18 years and older with bipolar I disorder who are prescribed a mood stabilizer medicati on, with adherence to the mood stabilizer medication [defined as a Proportion of Days Covered (PDC)] of at least 0.8 during the measurement period (12 consecutive months) Commenters supported the inclusion of this measure in PQRS but request this measure also be reportable through registry. CMS confirmed with the measure steward that this measure was tested for reportability through claims and not registry. Given this, CMS does not believe this measure is ready for implementation in 2015 PQRS as CMS does not believe this measure is appropriate for claims-based reporting and thus CMS is not finalizing this m easure for reporting in 2015 PQRS. CMS/FM QAI X

N/ A /N/ A N/ A Person andCaregiverCentered Experience and Outcomes Average change in functional status following lumbar sp ine fusion surgery: Average change from pre-operative functional status assessment to one year (nine to fifteen months) post-operative functional status using the Oswestry Disability Index (ODI version 2.1a) patient reported outcome tool

Commenters note this measure has not been fully vetted or tested. Furthermore, there are analytic challenges to implementing this measure and the lack of a performance target to assess this measure against. For this reason, CMS is not finalizing this measure for inclus ion in 2015 PQRS. MNCM XCMS-1612-FC 733NQF/PQRSCMSE-Measure ID NQS Domain Measure Title and Description ¥Measure StewardClaimsCSVRegistryEHRGPRO (WebInterface)Measures GroupsOther QualityReportingPrograms

N/ A /N/ A N/ A Efficiency and Cost Reduction Avoidance of inappropriate use of imaging for adult ED patients with traumatic low back pain: Avoidance of inappropriate use of imaging for adult ED patients with traumatic low back pain While one commenter supported the addition of this measure to PQRS noting it “will incentivize providers to minimize unnecessary or excessive radiation exposure, which insures to the benefit of beneficiaries,” the measure steward withdrew support of th is measure as the measure is not yet sufficiently specified nor has it undergone public review and comment. For this reason, CMS is not finalizing this m easure for PQRS 2015. ACEP X

188 5 /N/ A N/ A Person andCaregiverCentered Experience and Outcomes Depression Response at Twelve MonthsProgress Towards Remission: Adult patients age 18 and older with major depression or dysthymia and an initial PHQ-9 (Patient Health Questionnaire 9) score greater than nine who demonstrate a response to treatment at twelve months defined as a PHQ-9 score that is reduced by 50% or greater from the initial PHQ-9 score. This measure applies to both patients with newly diagnosed or existing depression identified during the defined measurement period w hose current PHQ-9 score indicates a need for treatment CMS believes that NQF 1885 is duplicative of PQRS 370 “Depression Remission at Twelve Months.” As such, CMS is not finalizing its proposal to add NQF 1885 as a new measure for reporting in the 2015 PQRS Program. MNCM X

N/ A /N/ A N/ A Patient Safety Discontinuation of Antiviral Therapy for Inadequate Viral Response: Percentage of patients aged 18 years and older with a diagnosis of hepatitis C genotype 1 who had an inadequate response to antiviral treatment for whom antiviral treatment was discontinued Commenters, including the measure steward, suggest clin ical guidelines are changing for Hepatitis C virus therapy, impacting the clinical appropriateness of this measure specifically. No other measures under consideration were affected. As such, CM S is not finalizing this measure for PQ RS 2015, allowing time for the evolving clinical guidance to be finalized. AGA / AASLD /

PCPI XCMS-1612-FC 734NQF/PQRSCMSE-Measure ID NQS Domain Measure Title and Description ¥Measure StewardClaimsCSVRegistryEHRGPRO (WebInterface)Measures GroupsOther QualityReportingPrograms

N/ A /N/ A N/ A Effective Clinical

Care Freedom from Reintervention or Amputation Following Endovascular Infrainguinal Lower Extremity Revascularization for Non-limb threatening ischemia: Percentage of patients undergoing endovascular infrainguinal revascularization for non-limb threatening ischemia (claudication or asymptomatic) who do not require ipsilateral repeat revascularization or any amputation within one year The measure steward withdrew support of this measure as the measure specifications are incomplete at this time. For this reason, CMS is not finalizing this measure for PQRS 2015 but may cons ider this measure for a future program year. SVS X

N/ A /N/ A N/ A Effective Clinical

Care Freedom from Reintervention or Amputation Following Open Infrainguinal Lower Extremity Revascularization for non-limb threatening ischemia: Percentage of patients undergoing open infrainguinal revascularization for non-limb threatening ischemia (claudicati on or asymptomatic) who do not require ip silateral repeat revascularization or any amputation within one year The measure steward withdrew support of this measure as the measure specifications are incomplete at this time. For this reason, CMS is not finalizing this measure for PQRS 2015 but may cons ider this measure for a future program year. SVS X

662 /N/ A N/ A Communica tion and

Care Coordinatio n Median Time to Pain Management for Long Bone Fracture: Median time from emergency department (E D) arrival to time of initial oral, intranasal or parenteral pain medication administration for emergency department patients with a principal diagnosis of long bone fracture (LBF) While some commenters supported the inclusion of this m easure in PQRS, after further review CMS determined that comparison across measurement periods, particularly when the reporting period for the PQRS payment adjustments is a 12- month calendar year, poses an analytic challenge for reporting purposes. CMS currently does not have a measure in the PQRS where data is collected outside a respective reporting period and compared to an existing reporting period without an CMS/OF MQ XCMS-1612-FC 735NQF/PQRSCMSE-Measure ID NQS Domain Measure Title and Description ¥Measure StewardClaimsCSVRegistryEHRGPRO (WebInterface)Measures GroupsOther QualityReportingPrograms

establised performance met target. While we welcome intermediate outcome measures such as these, it is not technically feasible at this time to include this measure in the PQRS. For this reason, CMS is not finalizing its proposal to make this measure reportable beginning in 2015 for PQRS. ¥ Measure details including titles , descriptions and measure owne r information may vary during a particular program year. This is due to the timing of measure specification preparation and the m easure versions used by the va rious reporting options/methods. Please refer to the measure spec ifications that apply for each of the reporting options/m ethods for specific measure details. In Table 54, we provide our responses and final decisions on the measures for which we proposed a NQS domain change for reporting under the PQRS (79 FR 40419). Please note that we received comments regarding the process for changing a measur e’s domain. With respect to these comments, we appreciate the commenters’ suggestions regarding the process for domain changes for measures and will

take these comments under consideration. We are developing guidelines for assigning measure domains and will use these guidelines to assign each measure in the PQRS program to a NQS domain when measure stewards submit measures through the Call fo r Measures process each program year. We value feedback from measure developers and are dedicat ed to making updates to the PQRS program a transparent and collaborative process as it works to establish measures th at are applicable to various domain categories.CMS-1612-FC 736

TABLE 54: NQS Domain Changes for Indivi dual Quality Measures and Those Included in Measures Groups for the PQRS Beginning in 2015NQF/PQRSCMSE-Measure ID NQS Domain

2014 NQS Domain

2015 Measure Title and DescriptionClaimsCSVRegistryEHRGPRO (Web Interface)Measures GroupsOther Quality ReportingPrograms

Measures Finalized as Proposed

009 7/0 46 N/ A Patient Safety Commun ication and Care Coordina

tion Medication Reconciliation: Percentage of patients aged 18 years and older discharged from any inpatient facility (for example, hospital, skilled nursing facility, or rehabilitation facility) and seen within 30 days following discharge in the office by the physician, prescribing practitioner, registered nurse, or clinical pharmacist providing on-going care who had a reconciliation of the discha rge medications with the current medication list in the outpatient medical record documented. This measure is reported as two rates stratified by age group: Reporting Age Criteria 1: 18-64 years of age Reporting Age Criteria 2: 65 years and older. Commenters supported the proposed domain change for PQRS #46 from Patient Safety to Communication and Care Coordination. For this reason, CMS is finalizing its proposal to change the domain of this measure for 2015 PQRS. X X

065 0/1 37 N/ A Effective Clinical

Care Commun ication and Care Coordina

tion Melanoma: Continuity of Care – Recall System: Percentage of patients, regardless of age, with a current diagnosis of melanoma or a history of melanoma whose information was entered, at least once within a 12 month period, into a reca ll 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 Commenters supported the proposed domain change for PQRS #137 from Effectiv e Clinical Care to Communication and Care Coordination. For this reason, CMS is finalizing its proposal to change the domain of this meas ure for 2015 PQRS. X

N/ A/2 88 N/ A Effective Clinical

Care Commun ication and Care Coordina

tion Dementia: Caregiver Education and Support: Percentage of patients, regardless of age, with a diagnosis of dementia whose caregiver(s) were provided with education on dementia disease management and health behavior changes AND referred to additional sources for support within a 12 month period Commenters disagreed with the proposed domain change but did not explain why. However, while this measure does fall into both the Communication and Care Coordination and Pers on and Caregiver-Centered XCMS-1612-FC 737NQF/PQRSCMSE-Measure ID NQS Domain

2014 NQS Domain

2015 Measure Title and DescriptionClaimsCSVRegistryEHRGPRO (Web Interface)Measures GroupsOther Quality ReportingPrograms

Experience and Outcomes domains, Communication and Care Coordination should become the new primary domain. While the measure does target the education and referral of the patient's caregiver to supportive services, this is a secondary goal of the measure -- the primary intent is to disseminate information related to caring for a patient with dementia, including making connections to all potentially necessary providers. For these reasons, CMS is finalizi ng its proposal to change the domain of this m easure for 2015 PQRS.

N/ A/2 93 N/ A Effective Clinical

Care Commun ication and Care Coordina

tion Parkinson’s Disease: Rehabilitative Therapy Options: All patients with a di agnosis of Parkinson’s disease (or caregiver(s), as appropriate) who had rehabilitative therapy options (for example, physical, occupational, or speech therapy) discussed at least annually No comments were received regarding the domain for this measure. CMS is finali zing its proposal to change the domain of this m easure for 2015 PQRS. X

N/ A/2 94 N/ A Effective Clinical

Care Commun ication and Care Coordina

tion 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 opti ons (for example, nonpharmacological treatment, pharmacological treatment, or surgical treatment) reviewed at least once annually No comments were received regarding the domain for this measure. CMS is finali zing its proposal to change the domain of this m easure for 2015 PQRS. X

N/ A/3 25 N/ A Effective Clinical

Care Commun ication and Care Coordina

tion Adult Major Depressive Disorder (MDD): Coordination of Care of Patients with Specific Comorbid Conditions: Percentage of medical records of patients aged 18 years and older with a diagnosis of major depressive disorder (MDD) and a specific diagnosed comorbid condition (diabetes, coronary artery disease, ischemic stroke, intracranial hemorrhage, chronic kidney disease [stages 4 or 5], End Stage Renal Disease [ESRD] or congestive heart failure) being treated by another clinician with communication to the clinician treating the comorbid condition Commenters supported the proposed domain change for PQRS #325 from Effectiv e Clinical Care to Communication and Care Coordination. For this reason, CMS is finalizing its proposal to change the domain of this meas ure for 2015 PQRS. X

N/ A/3 03 N/ A Effective Clinical

Care Person and CaregiverCataracts: 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 X XCMS-1612-FC 738NQF/PQRSCMSE-Measure ID NQS Domain

2014 NQS Domain

2015 Measure Title and DescriptionClaimsCSVRegistryEHRGPRO (Web Interface)Measures GroupsOther Quality ReportingPrograms

Centered Experien

ce and Outcome s improvement in visual function achieved within 90 days following the cataract surgery, based on completing a pre-operative a nd post-operative visual function survey No comments were received regarding the domain for this measure. CMS is finali zing its proposal to change the domain of this m easure for 2015 PQRS.

N/ A/3 31 N/ A Effective Clinical

Care Efficienc y and Cost Reductio n Adult Sinusitis: Antibiot ic Prescribed for Acute Sinusitis (Appropriate Use): Percentage of patients, aged 18 years and older, with a diagnosis of acute sinusitis who were prescribed an antibiotic within 7 days of diagnosis or with in 10 days after onset of symptoms Commenters supported the proposed domain change for PQRS #331 from Effectiv e Clinical Care to Efficiency and Cost Reduction. For this reason, CMS is finalizing its proposal to change the domain of this measure for 2015 PQRS. X X

N/ A/3 32 N/ A Effective Clinical

Care Efficienc y and Cost Reductio n Adult Sinusitis: Appropri ate Choice of Antibiotic: Amoxicillin Prescribed for Patients with Acute Bacterial Sinusitis (Appropriate Use): Percentage of patients aged 18 years and older with a diagnosis of acute bacterial sinusitis that were prescribed amoxicillin, with or without clavulante, as a first line antibiotic at the time of diagnosis Commenters supported the proposed domain change for PQRS #332 from Effectiv e Clinical Care to Efficiency and Cost Reduction. For this reason, CMS is finalizing its proposal to change the domain of this measure for 2015 PQRS. X X

N/ A/3 47 N/ A Effective Clinical

Care Patient Safety Rate of Endovascular Aneurysm Repair (EVAR) of Small or Moderate Non-Ruptured Abdominal Aortic Aneurysms (AAA) Who Die While in Hospital: Percent of patients undergoing endovascular repair of small or moderate abdominal aortic aneurysms (AAA) who die while in the hospital No comments were received regarding the domain for this measure. CMS is finali zing its proposal to change the domain of this m easure for 2015 PQRS. X

N/ A/3 48 N/ A Effective Clinical

Care Patient Safety HRS-3: Implantable Cardioverter-Defibrillator (ICD) Complications Rate: Patients with physicianspecific risk-standardized rates of procedural complications following the first time implantation of an ICD No comments were received regarding the domain for this measure. CMS is finali zing its proposal to change the domain of this m easure for 2015 PQRS. X

N/ A/3 54 N/ A Effective Clinical

Care Patient Safety Anastomotic Leak Intervention: Percentage of patients aged 18 years and older who required an anastomotic leak interventi on following gastric bypass XCMS-1612-FC 739NQF/PQRSCMSE-Measure ID NQS Domain

2014 NQS Domain

2015 Measure Title and DescriptionClaimsCSVRegistryEHRGPRO (Web Interface)Measures GroupsOther Quality ReportingPrograms

or colectomy surgery No comments were received regarding the domain for this measure. CMS is finali zing its proposal to change the domain of this m easure for 2015 PQRS.

N/ A/3 55 N/ A Effective Clinical

Care Patient Safety Unplanned Reoperation within the 30 Day Postoperative Period: Percentage of patients aged 18 years and older who had any unplanned reoperation within the 30 day postoperative period No comments were received regarding the domain for this measure. CMS is finali zing its proposal to change the domain of this m easure for 2015 PQRS. X

004

3 /11

1 12 7v 3 Effective Clinical

Care Commun ity/Popul

ation Health Pneumonia Vaccination Status for Older Adults: Percentage of patients 65 years of age and older who have ever received a pneumococcal vaccine No comments were received regarding the domain for this measure. CMS is finali zing its proposal to change the domain of this m easure for 2015 PQRS. X X X X X ACO MU2

032 1/0 82 N/ A Commun ication and Care Coordina

tion Effective Clinical

Care Adult Kidney Disease: Peritoneal Dialysis Adequacy: Solute: Percentage of patients aged 18 years and older with a diagnosis of End Stage Renal Disease (ESRD) receiving per itoneal dialysis who have a total Kt/V ≥ 1.7 per week measured once every 4 months Commenters supported the proposed domain change for PQRS #82 from Communication and Care Coordination to Effective Clinical Care. For this reason, CMS is finalizing its proposal to change the domain of this meas ure for 2015 PQRS. X

N/ A/1 80 N/ A Commun ication and Care Coordina

tion Effective Clinical

Care Rheumatoid Arthritis (RA): Glucocorticoid Management : Percentage of patients aged 18 years and older with a diagnosis of rheumatoid arthritis (RA) who have been assessed for gl ucocorticoid 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 Commenters supported the proposed domain change for PQRS #180 from Communication and Care Coordination to Effective Clinical Care. For this reason, CMS is finalizing its proposal to change the domain of this meas ure for 2015 PQRS. X AQA

N/ A/2 80 N/ A Commun ication and Care Coordina

tion Effective Clinical

Care Dementia: Staging of Dementia: Percentage of patients, regardless of ag e, with a diagnosis of dementia whose severity of dementia was classified as mild, moderate or severe at least once within a 12 month period Commenters supported the proposed domain change XCMS-1612-FC 740NQF/PQRSCMSE-Measure ID NQS Domain

2014 NQS Domain

2015 Measure Title and DescriptionClaimsCSVRegistryEHRGPRO (Web Interface)Measures GroupsOther Quality ReportingPrograms

for PQRS #280 from Communication and Care Coordination to Effective Clinical Care. For this reason, CMS is finalizing its proposal to change the domain of this meas ure for 2015 PQRS.

065 4/0 93 N/ A Commun ication and Care Coordina

tion Efficienc y and Cost Reductio n Acute Otitis Externa (AOE): Systemic Antimicrobial Therapy – Avoidance of Inappropriate Use: Percentage of patients aged 2 years and older with a dia gnosis of AOE who were not prescribed systemic antimicrobial therapy Commenters supported the proposed domain change for PQRS #93 from Communication and Care Coordination to Efficiency and Cost Reduction. For this reason, CMS is finaliz ing its proposal to change the domain of this m easure for 2015 PQRS. X X X

N/ A/2 58 N/ A Commun ication and Care Coordina

tion Patient Safety Rate of Open Repair of Small or Moderate NonRuptured Abdominal Aortic Aneurysms (AAA) without Major Complications (Discharged to Home by Post-Operative Day #7): Percent of patientsundergoing open repair of small or moderate sized nonruptured abdominal aortic aneurysms who do not experience a major complication (discharge to home no later than post-operative day #7) No comments were received regarding the domain for this measure. CMS is finali zing its proposal to change the domain of this m easure for 2015 PQRS. X

N/ A/2 59 N/ A Commun ication and Care Coordina

tion Patient Safety Rate of Endovascular Aneurysm Repair (EVAR) of Small or Moderate Non-Ruptured Abdominal Aortic Aneurysms (AAA) without MajorComplications (Discharged to Home by PostOperative Day #2): Percent of patients undergoing endovascular repair of small or moderate non-ruptured abdominal aortic aneurysms (AAA) that do not experience a major complication (discharged to home no later than post-operative day #2) No comments were received regarding the domain for this measure. CMS is finali zing its proposal to change the domain of this m easure for 2015 PQRS. X

N/ A/2 60 N/ A Commun ication and Care Coordina

tion Patient Safety Rate of Carotid Endarterectomy (CEA) for Asymptomatic Patients, without MajorComplications (Discharged to Home by PostOperative Day #2): Percent of asymptomatic patients undergoing CEA who are discharged to home no later than post-operative day #2 No comments were received regarding the domain for this measure. CMS is finali zing its proposal to change the domain of this m easure for 2015 PQRS. X

152 5/3 26 N/ A Patient Safety Effective Clinical

Care Atrial Fibrillation and Atrial Flutter: Chronic Anticoagulation Therapy: Percentage of patients aged 18 years and older with a diagnosis of nonvalvular X XCMS-1612-FC 741NQF/PQRSCMSE-Measure ID NQS Domain

2014 NQS Domain

2015 Measure Title and DescriptionClaimsCSVRegistryEHRGPRO (Web Interface)Measures GroupsOther Quality ReportingPrograms

atrial fibrillation (AF) or atrial flutter whose assessment of the specified thromboembolic risk factors indicate one or more high-risk factors or more than one moderate risk factor, as determined by CHADS2 risk stratification, who are prescribed warfarin OR another oral anticoagulant drug that is FDA approved for the prevention of thromboembolism One commenter agreed while another commenter disagreed with the proposal to change the domain of PQRS #326 from Patient Safety to Effective Clinical Care noting “providing anticoagulation therapy for atrial fibrillation and atrial flutter patients is a means of reducing the risk of stroke in patients presenting for more high- or moderate-risk factors.” While not using warfarin or another anticoagulation therapy is "a means of reducing the risk of stroke in patients presenting for more high- or moderate-risk factors," this is a secondary outcome of providing the medication, not a direct risk caused by the delivery of care. So, while taking warfarin or another anticoagulant may provide protection against stroke, it is not the primary intent of the measure. For these reasons, CMS is finalizing its proposal to change the domai n of this measure for 2015 PQRS.

N/ A/3 21 N/ A Commun ication and Care Coordina

tion Person and Caregive r Experien

ce and Outcome s CAHPS for PQRS Clinician/Group Survey: • Getting timely care, appointments, and information; • How well providers Communicate; • Patient’s Rating of Provider; • Access to Specialists; • Health Promotion & Education; • Shared Decision Making; • Health Status/Functional Status; • Courteous and Helpful Office Staff; • Care Coordination; • Between Visit Communication; • Helping Your to Take Me dication as Directed; and • Stewardship of Patient Resources No comments were received regarding the domain for this measure. CMS is finali zing its proposal to change the domain of this m easure for 2015 PQRS. X ACO

Measures Not Finalized as Proposed

N/ A/3 56 N/ A Effective Clinical

Care Commun ication and Care Coordina

tion Unplanned Hospital Readmission within 30 Days of Principal Procedure: Percentage of patients aged 18 years and older who had an unplanned hospital readmission within 30 days of principal procedure One commenter disagreed with CMS’ proposal to change the domain of th is measure noting that "unplanned readmissions can be the result of many factors which extend well beyond communication and care coordination." The commenter suggested keeping XCMS-1612-FC 742NQF/PQRSCMSE-Measure ID NQS Domain

2014 NQS Domain

2015 Measure Title and DescriptionClaimsCSVRegistryEHRGPRO (Web Interface)Measures GroupsOther Quality ReportingPrograms

Effective Clinical Care as the NQS domain. CMS agreed with the commenter and is not finalizing its proposal to change the domain of PQRS #356 from Effective Clinical Care to Communication and Care Coordination for 2015 PQRS . This measure will remain as Effective Clini cal Care in the 2015 PQRS measure set. ¥ Measure details including titles, descriptions and measur e owner information may vary during a particular program year. This is due to the timing of measure specification pr eparation and the measure versions used by the various reporting options/methods. Please refer to the measure specifications that apply for each of the reporting options/methods for specific measure details. In Table 55, we provide the responses and final d ecisions related to the measures we proposed to remove from reporting under the PQRS (79 FR 40426).CMS-1612-FC 743

TABLE 55: Measures Being Removed from the Ex isting PQRS Measure Set Beginning in 2015NQF/PQRS NQS Domain Measure Title and Description ¥Measure StewardClaimsCSVRegistryEHRGPRO (WebInterface)Measures GroupsOther QualityReportingPrograms

Measures Finalized as Proposed

0270/020 Patient Safety Perioperative Care: Timing of Prophylactic Parenteral Antibiotic – Ordering Physician: Percentage of surgical patients aged 18 years and older undergoing procedures with the indications for prophylactic parenteral antibiotics, who have an order for prophylactic parenteral antibiotic to be given within one hour (if fluoroquinolone or vancomycin, 2 hours), prior to the surgical incision (or start of procedure when no incision is required) Some commenters disagreed with CMS’ proposal to remove this measure noting “disparate practi ce patterns among clinicians when selecting the more appropriate prophylactic antibiotic.” However, other commenters agreed with CMS’ proposal to re move this measure given the measure’s “emphasis on administration rather than ordering of antibiotics.” For this reason and given the measure’s high rate of performance in previous reporting years, CMS is finalizing its proposal to remove this measure from reporting in 2015 PQRS. AMAPCPI NCQA X X X

0092/028 Effective Clinical

Care Aspirin at Arrival for Acute Myocardial Infarction (AMI): Percentage of patients, regardless of age, with an emergency department discharge diagnosis of acute myocardial infarction (AMI) who had documentation of receiving aspirin within 24 hours before emergency department arrival or during emergency department stay Commenters disagreed with CMS’ proposal to remove this measur e noting it presents a “reporting opportunity for emergency physicians” which could create a reporting gap for that segment of providers reporting to PQRS. However, CMS continues to believe this measure represents a clinical concept that has been substantially adopted for initial treatment of patients suffering from acute myocardial infarction when clinically indicated. For this reason, CMS is finalizing its proposal to remove this measure from reporting in 2015 PQRS. AMAPCPI NCQA X X

0269/030 Patient Safety Perioperative Care: Timing of Prophylactic Antibiotic—Administering Physician: Percentage of surgical patients aged 18 years and older who receive an anesthetic when undergoing procedures with the indications for prophylactic AAO X XCMS-1612-FC 744NQF/PQRS NQS Domain Measure Title and Description ¥Measure StewardClaimsCSVRegistryEHRGPRO (WebInterface)Measures GroupsOther QualityReportingPrograms

parenteral antibiotics for whom administration of a pr ophylactic parenteral antibiotic ordered has been initiated within 1 hour (if fluoroquinolone or vancomycin, 2 hours) prior to the surgical incision (or start of procedure when no incision is required) Commenters disagreed with CMS’ proposal to remove this measure noting “it is premature to remove a measure based on a high-performance rate when the EP reporting rate within the PQRS program is low.” With a performance rate above 90 percent for multiple consecutive years, CMS considers the measure to have reached its potential, and no longer represents a clinical performance gap that should be measured by the PQRS Program. Additionally, CMS will apply the Measure Applicability Validation (MAV) process for claims-based reporting in those cases where specialists do not have enough relevant measures to report. For this reason, CMS is finalizing its proposal to remove this measure from reporting in 2015 PQRS.

0240/031 Effective Clinical

Care Stroke and Stroke Rehabilitation: Venous Thromboembolism (VTE) 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 venous thromboembolism (VTE) prophylaxis the day of or the day after hospital admission Commenters disagreed with CMS' proposal to remove this measure. Commenters maintain that these clinical concepts are appropriate for measurement at the individual physician level in addition to the facility level to help ensure the continuous care of stroke patients. CMS believes this measure represents a basic standard of care and does not add clinical value to PQRS at this time. For this reason, CMS is finalizing its proposal to remove this measure from reporting in 2015 PQRS. AANI X X

0243/035 Effective Clinical

Care Stroke and Stroke Rehabilitation: Screening for Dysphagia: Percentage of patients aged 18 years and older with a diagnosis of ischemic stroke or intracranial hemorrhage who receive any food, fluids or medication by mouth (PO) for whom a dysphagia screening was performed prior to PO intake in accordance with a dysphagia screening tool approved by the institution in which the patient is receiving care AANI X XCMS-1612-FC 745NQF/PQRS NQS Domain Measure Title and Description ¥Measure StewardClaimsCSVRegistryEHRGPRO (WebInterface)Measures GroupsOther QualityReportingPrograms

Commenters disagreed with CMS' proposal to remove this measure as they maintain that these clinical concepts are appropriate for measurement at the individual physician level in addition to the facility level to help ensure the continuous care of stroke patients. CMS continues to believe this measure represents a basic standard of care and does not add clinical value to PQRS at this time. For this reason, CMS is finalizing its proposal to remove this measure from reporting in 2015 PQRS.

0244/036 Effective Clinical

Care 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, phys ical, 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 Commenters disagreed with CMS' proposal to remove this measure as they maintain that these clinical concepts are appropriate for measurement at the individual physician level in addition to the facility level to help ensure the continuous care of stroke patients. CMS continues to believe this measure represents a basic standard of care and does not add clinical value to PQRS at this time. For this reason, CMS is finalizing its proposal to remove this measure from reporting in 2015 PQRS. AANI X X

0637/045 Patient Safety Perioperative Care: Discontinuation of Prophylactic Parenteral Antibiotics (Cardiac Procedures): Percentage of cardiac surgical patients aged 18 years and older undergoing procedures with the indications for prophylactic parenteral antibiotics AND who received a prophylactic parenteral antibiotic, who have an order for discontinuation of prophylactic parenteral antibiotics within 48 hours of surgical end time Commenters disagreed with CMS’ proposal to remove this meas ure, noting “it is premature to remove a measure based on a high-performance rate when the EP reporting rate within the PQRS program is low.” With a performance rate above 90 percent for multiple consecutive years, CMS considers the measure to have reached AMAPCPI NCQA X XCMS-1612-FC 746NQF/PQRS NQS Domain Measure Title and Description ¥Measure StewardClaimsCSVRegistryEHRGPRO (WebInterface)Measures GroupsOther QualityReportingPrograms

its potential, and no longer represent a clinical performance gap that should be measured by the PQRS Program. The PQRS will continue to focus on measures with maximal potent ial for improvement and that answer a clinical performance gap. For this reason, CMS is finalizing its proposal to remove this measure from reporting in 2015 PQRS.

0099/049 Effective Clinical

Care 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 Commenters disagreed with removal of this measure due to high performance rates indicating this is not a good enough reason to remove a measure from the program. With a performance rate above 90 percent for multiple consecutive years, CMS considers the measure to have reached its potential, and no longer represent a clinical performance gap that should be measured by the PQRS Program. The PQRS will continue to focus on measures with maximal potential for improvement and that answer a clinical performance gap. For this reason, CMS is finalizi ng its proposal to remove this measure from 2015 PQRS. NCQA/AMAPCPI X X

0093 /055 Effective Clinical

Care 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 electrocardiogram (ECG) performed Commenters disagreed with CMS’ proposal to remove this meas ure, noting “it is premature to remove a measure based on a high-performance rate when the EP reporting rate within the PQRS program is low.” With a performance rate above 90 percent for multiple consecutive years, CMS considers the measure to have reached its potential, and no longer represent a clinical performance gap that should be measured by the PQRS Program. The PQRS will continue to focus on measures with maximal potent ial for improvement and that answer a clinical performance gap. For this reason, CMS is finalizing its proposal to remove this measure from reporting in 2015 PQRS. AMAPCPI /NCQA X XCMS-1612-FC 747NQF/PQRS NQS Domain Measure Title and Description ¥Measure StewardClaimsCSVRegistryEHRGPRO (WebInterface)Measures GroupsOther QualityReportingPrograms

0232 /056 Effective Clinical

Care Emergency Medicine: CommunityAcquired Bacterial Pneumonia (CAP): Vital Signs: Percentage of patients aged 18 years and older with a diagnosis of community-acquired bacterial pneumonia (CAP) with vital signs documented and reviewed Commenters disagreed with CMS’ proposal to remove this measure noting “it is premature to remove a measure based on a high-performance rate when the EP reporting rate within the PQRS program is low.” With a performance rate above 90 percent for multiple consecutive years, CMS considers the measure to have reached its potential, and no longer represent a clinical performance gap that should be measured by the PQRS Program. The PQRS will continue to focus on measures with maximal potential for improvement and that answer a clinical performance gap. For this reason, CMS is finalizi ng its proposal to remove this measure from reporting in 2015 PQRS. AMAPCPI /NCQA X X

0096 /059 Effective Clinical

Care Emergency Medicine: CommunityAcquired Bacterial Pneumonia (CAP): Empiric Antibiotic: Percentage of patients aged 18 years and older with a diagnosis of community-acquired bacterial pneumonia (CAP) with an appropriate empiric antibiotic prescribed Commenters disagreed with CMS’ proposal to remove this measure noting “it is premature to remove a measure based on a high-performance rate when the EP reporting rate within the PQRS program is low.” With a performance rate above 90 percent for multiple consecutive years, CMS considers the measure to have reached its potential, and no longer represent a clinical performance gap that should be measured by the PQRS Program. The PQRS will continue to focus on measures with maximal potent ial for improvement and that answer a clinical performance gap. For this reason, CMS is finalizing its proposal to remove this measure from reporting in 2015 PQRS. AMAPCPI /NCQA X X

0001/064 Effective Clinical

Care Asthma: Assessment of Asthma Control – Ambulatory Care Setting: Percentage of patients aged 5 through 64 years with a diagnosis of asthma w ho were evaluated at least once during the measurement period for asthma control (comprising asthma impairment and asthma risk) AMAPCPI NCQA X XCMS-1612-FC 748NQF/PQRS NQS Domain Measure Title and Description ¥Measure StewardClaimsCSVRegistryEHRGPRO (WebInterface)Measures GroupsOther QualityReportingPrograms

Some commenters disagreed with the removal of this measure noting “this [assessment] is essential in order to ensure appropriate treatment for asthma which currently is less than optimal.” However, other commenters supported the removal of this measure. CMS continues to believe this measure represents a basic clinical concept that does not add clinical value to PQRS because in order to provide effective treatment for asthma, assessment of asthma control is essential. As such, CMS is finalizing its propos al to remove PQRS #064, “Asthma: Assess ment of Asthma Control – Ambulatory Care Setting," which is a process measure, and replace it with the more robust outcome measure, Optimal Asthma - Control Component based on our exception authority under section 1848(k)(2)(C)(ii) of the Act that provides an exception to the requirement that the Secretary select measur es must be endorsed by NQF.

0393/083 Effective Clinical

Care Hepatitis C: Confirma tion of Hepatitis C Viremia: Percentage of patients aged 18 years and older who are hepatitis C antibody positive seen for an initial evaluation for whom hepatitis C virus (HCV) RNA testing was ordered or previously performed One commenter disagreed with the removal of this measure noting a recent study of four large health systems revealed that “less than two-thirds of persons with positive HCV antibody test had a follow-up RNA test.” Despite these findings, eligible professionals have c onsistently reported performance rates close to 100% for this measure. With a perfo rmance rate above 90 percent for multiple consecutive years, CMS considers the measure to have reached its potential, and no longer represents a clinical performance gap that should be measured by the PQRS Program. The PQRS will continue to focus on measures with maximal potent ial for improvement and that answer a clinical performance gap. For these reasons, CMS is finalizing its proposal to remove this measure from reporting in 2015 PQRS. AGA X

0103/106 Effective Clinical

Care Adult Major Depressive Disorder (MDD): Comprehensive Depression Evaluation: Diagnosis and Severity: Percentage of patients aged 18 years and older with a new diagnosis or recurrent episode of major depressive disorder APA X XCMS-1612-FC 749NQF/PQRS NQS Domain Measure Title and Description ¥Measure StewardClaimsCSVRegistryEHRGPRO (WebInterface)Measures GroupsOther QualityReportingPrograms

(MDD) with evidence that they met the Diagnostic and Statistical Manual of Mental Disorders (DSM)-5 criteria for MDD AND for whom there is an assessment of depression severity during the visit in which a new diagnosis or recurrent episode was identified Commenters disagreed with CMS’ proposal to remove this measure noting “appropriate diagnosis and classification of severity are essential in order to ensure appropriate treatment for major depressive disorder. The use of the diagnostic tools included in the measure is currently less than optimal.” Furthermore, commenter s suggest the other MDD measure (PQRS #370) “does not include screening for bipolar disorder and could potentially exclude some patients from screening.” However, CMS continues to believe it represents a clinically diagnostic reference that is commonly utilized as a standard practice of care in order to diagnose and treat mental health disorders. This measure is not robust and does not add clinical value to the PQRS program. It is a goal of CMS to increase the number of outcome-based measures in the PQRS program, and meas ures that work to appropriately diagnose and classify the severity of illnesses and include quality care action are essential for this effort. For these reasons, CMS is finalizi ng its proposal to remove this measure from reporting in 2015 PQRS.

1666/123 Effective Clinical

Care Adult Kidney Disease: Patients On Erythropoiesis-Stimula ting 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 erythropoiesis-stimula ting agent (ESA) therapy AND have a hemoglobin level > 12.0 g/dL Some commenters suggested CMS not remove this measure, noting it is “an assessment that is required for making treatment decisions.” CMS agrees this measure is both an effective clinical care and overuse measure. However, RPA X X XCMS-1612-FC 750NQF/PQRS NQS Domain Measure Title and Description ¥Measure StewardClaimsCSVRegistryEHRGPRO (WebInterface)Measures GroupsOther QualityReportingPrograms

commenters that agreed with removal of this measure came from specialists who would most likely be re porting this measure. As such, CMS is fina lizing its proposal to remove PQRS 123.

0051/142 Effective Clinical

Care Osteoarthritis (OA): Assessment for Useof Anti-Inflammatory or Analgesic Overthe-Counter (OTC) Medications: Percentage of patient vi sits for patients aged 21 years and older with a diagnosis of osteoarthritis (OA) with an assessment foruse of anti-inflammatory or analgesic overthe-counter (OTC) medications

A steward has still not been identified for this measure, and for this reason CMS is finalizing its proposal to remove this measure from reporting in 2015 PQRS. AMAPCPI X X

0322/148 Efficiency and Cost Reduction 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 Some commenters supported the removal of this measure while others expressed concern over its removal and the negative impact on anesthesiologists and pain medicine physicians to report PQRS. CMS understands the commenters’ concerns. It is a priority for PQRS to ultimately increase the quality of health care, and promoting outcome-based measures is part of this effort. This measure and others in the Back Pain Measure Group represent clinical assessments and recommendations commonly utilized to provide effective treatment for patients diagnosed with back pain, and thus, were determined to be low bar, process-based measures that do not meaningfully contribute to improved patient outcomes or the PQRS program. For this reason, CMS is finalizi ng its proposal to remove this measure an d other measures in the Back Pain Measures Group from the PQRS program in 2015. NCQA X

0319/149 Effective Clinical

Care 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 Some commenters supported the removal of this measure while others expressed concern NCQA XCMS-1612-FC 751NQF/PQRS NQS Domain Measure Title and Description ¥Measure StewardClaimsCSVRegistryEHRGPRO (WebInterface)Measures GroupsOther QualityReportingPrograms

over its removal and the negative impact on anesthesiologists and pain medicine physicians to report PRQS. CMS understands the commenters’ concerns. It is a priority for PQRS to ultimately increase the quality of health care and promoting outcome-based measures is part of this effort. This measure and others in the Back Pain Measure Group represent clinical assessments and recommendations commonly utilized to provide effective treatment for patients diagnosed with back pain, and thus, were determined to be low bar, process-based measures that do not meaningfully contribute to improved patient outcomes or the PQRS program. For this reason, CMS is finalizi ng its proposal to remove this measure an d other measures in the Back Pain Measures Group from the PQRS program in 2015.

0314/150 Effective Clinical

Care 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 Some commenters expressed concern over the removal of this measure and the negative impact on anesthesiologists and pain medicine physicians to report PRQS. CMS understands the commenters’ concerns. It is a priority for PQRS to ultimately increase the quality of health care and promoting outcome- based measures is part of this effort. Th is measure and others in the Back Pain Measure Group represent clinical assessments and recommendations commonly utilized to provide effective treatment for patients diagnosed with back pain, and thus, were determined to be low bar, process-based measures that do not meaningfully contribute to improved patient outcomes or the PQRS program. For this reason, CMS is finalizi ng its proposal to remove this measure an d other measures in the Back Pain Measures Group from the PQRS program in 2015. NCQA X

0313/151 Effective Clinical

Care 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 visi t to the clinician for the episode of back pain NCQA XCMS-1612-FC 752NQF/PQRS NQS Domain Measure Title and Description ¥Measure StewardClaimsCSVRegistryEHRGPRO (WebInterface)Measures GroupsOther QualityReportingPrograms

Some commenters supported the removal of this measure while others expressed concern over its removal and the negative impact on anesthesiologists and pain medicine physicians to report PRQS. CMS understands the commenters’ concerns. It is a priority for PQRS to ultimately increase the quality of health care and promoting outcome-based measures is part of this effort. This measure and others in the Back Pain Measure Group represent clinical assessments and recommendations commonly utilized to provide effective treatment for patients diagnosed with back pain, and thus, were determined to be low bar, process-based measures that do not meaningfully contribute to improved patient outcomes or the PQRS program. For this reason, CMS is finalizi ng its proposal to remove this measure an d other measures in the Back Pain Measures Group from the PQRS program in 2015.

0455/157 Patient Safety Thoracic Surgery: Recording of Clinical Stage Prior to Lung Cancer or Esophageal 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 Commenters disagreed with removal of this measure noting that removal based on a high-performance rate . With a performance rate above 90 percent for multiple consecutive years, CMS considers the measure to have reached its potential, and no longer represent a clinical performance gap that should be m easured by the PQRS Program. The PQRS will continue to focus on measures with maximal potential for improvement and that answer a clinical performance gap. For this reason, CMS is finalizing its proposal to remove this measure from 2015 PQRS. STS X X

0404/159 Effective Clinical

Care HIV/AIDS: CD4+ Cell Count or CD4+ Percentage Performed: Percentage of patients aged 6 mont hs 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 Commenters disagreed with the removal of this measure based on a rationale of a high performance rate. With a performance rate above 90 percent for multiple consecutive years, CMS considers the measure to have reached its potential, and no longer AMAPCPI NCQA X XCMS-1612-FC 753NQF/PQRS NQS Domain Measure Title and Description ¥Measure StewardClaimsCSVRegistryEHRGPRO (WebInterface)Measures GroupsOther QualityReportingPrograms

represent a clinical performance gap that should be measured by the PQRS Program. The PQRS will con tinue to focus on measures with maximal potential for improvement and that answer a clinical performance gap. Furthermore, other commenters agreed with the removal of this measure indicating “t his measure is no longer as relevant now that we are measuring CD4 less frequently and such measurement is optiona l in the Department of Health and Human Services Guidelinesfor the Use of Antiretroviral Agents in HIV1-Infected Adults and Adolescents for those suppressed for at least 2 years.” For these reasons, CMS is finalizi ng its proposal to remove this measure from reporting in 2015 PQRS.

0116/169 Effective Clinical

Care Coronary Artery Bypass Graft (CABG): Antiplatelet Medications at Discharge: Percentage of patients aged 18 years and older undergoing isolated CABG surgery who were discharged on antiplatelet medication Commenters disagreed with removal of this measure noting that removal based on a high-performance rate . With a performance rate above 90 percent for multiple consecutive years, CMS considers the measure to have reached its potential, and no longer represent a clinical performance gap that should be m easured by the PQRS Program. The PQRS will continue to focus on measures with maximal potential for improvement and that answer a clinical performance gap. For this reason, CMS is finalizing its proposal to remove this measure from 2015 PQRS. STS X X

0117/170 Effective Clinical

Care Coronary Artery Bypass Graft (CABG): Beta-Blockers Administered at Discharge: Percentage of patients aged 18 years and older undergoing isolated CABGsurgery who were discharged on betablockers Commenters disagreed with removal of this measure noting that removal based on a high-performance rate . With a performance rate above 90 percent for multiple consecutive years, CMS considers the measure to have reached its potential, and no longer represent a clinical performance gap that should be m easured by the PQRS Program. The PQRS will continue to focus on measures with maximal potential for improvement and that answer a clinical STS X XCMS-1612-FC 754NQF/PQRS NQS Domain Measure Title and Description ¥Measure StewardClaimsCSVRegistryEHRGPRO (WebInterface)Measures GroupsOther QualityReportingPrograms

performance gap. For this reason, CMS is finalizing its proposal to remove this measure from 2015 PQRS.

0118/171 Effective Clinical

Care 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 Commenters disagreed with removal of this measure noting that removal based on a high-performance rate . With a performance rate above 90 percent for multiple consecutive years, CMS considers the measure to have reached its potential, and no longer represent a clinical performance gap that should be m easured by the PQRS Program. The PQRS will continue to focus on measures with maximal potential for improvement and that answer a clinical performance gap. For this reason, CMS is finalizing its proposal to remove this measure from 2015 PQRS. STS X X

0074/197 Effective Clinical

Care Coronary Artery Disease (CAD): Lipid Control: Percentage of patients aged 18 years and older with a diagnosis of coronary artery disease seen w ithin a 12 month period who have a LDL-C result < 100 mg/dL OR patients who have a LDL-C result ≥ 100 mg/dL and have a documented plan of care to achieve LDL-C <100 mg/dL, including at a minimum the prescription of a statin Many commenters supported the proposed removal of the measure because the measure may not align with current clinical guidelines. Other commenters disagreed with the removal of this measure indicating the measure is currently in the process of being updated. CMS continues to believe that because of changes to the applicable evidence-based guidelines, this measure is no longer clinically valid. For this reason, CMS is finalizing its proposal to remove this measure from reporting for 2015 PQRS and Medicare Shared Savings Program. AMAPCPI ACCF AHA X X X

0079/198 Effective Clinical

Care Heart Failure: Left Ventricular Ejection Fraction (LVEF) Assessment: Percentage of patients aged 18 years and older with a diagnosis of heart fa ilure for whom the quantitative or qualitative results of a recent or prior [any time in the past] LVEF assessment is documented within a 12 month period AMAPCPI ACCF AHA X XCMS-1612-FC 755NQF/PQRS NQS Domain Measure Title and Description ¥Measure StewardClaimsCSVRegistryEHRGPRO (WebInterface)Measures GroupsOther QualityReportingPrograms

Several comments sugge sted CMS maintain this measure as it is important to clinical practice and has strong impact on patient symptom management. However, CMS continues to believe this measure represents a clinical concept that does not add clinical value to PQRS. LVEF testing is basic assessment for patients with heart failure. For these reasons, CMS is finalizing its proposal to remove this measure from 2015 PQRS.

N/A /228 Effective Clinical

Care Heart Failure (HF): Left Ventricular Function (LVF) Testing: Percentage of patients 18 years and older with Left Ventricular Function (LVF) testing documented as being performed within the previous 12 months or LVF testing performed prior to discharge for patients who are hospitalized with a principal diagnosis of Heart Failure (HF) during the reporting period Several comments sugge sted CMS maintain this measure as it is important to clinical practice. However, CMS continues to believe this measure represents a clinical concept that does not add clinical value to PQRS. LVF testing is basic assessment for patients with heart failure. For these reasons, CMS is finalizi ng its proposal to remove this measure from reporting in 2015 PQRS. CMS/QIP X

N/A/231 Effective Clinical

Care Asthma: Tobacco Use: Screening - Ambulatory Care Setting: Percentage of patients aged 5 through 64 years with a diagnosis of asthma (or their primary caregiver) 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 Commenters disagreed with CMS' proposal to replace PQRS #231 (Asthma: Tobacco Use: Screening - Ambulatory Care Setting) with PQRS #226 "Preventive Care and Screening: Tobacco Use: Screening and Cessation Intervention" because PQRS #231 includes an age range of 5-64 while the lower bound age for PQRS #226 is 18 years, missing the pediatric population. Furthermore, PQRS #226 does not include the query regarding exposure to second hand smoke which is cri tical for the 18 and under population with Asthma. However, CMS continues to believe this is measure is appropriate and more broadly applicable and for this reason is finalizing the proposal AMAPCPI NCQA X X XCMS-1612-FC 756NQF/PQRS NQS Domain Measure Title and Description ¥Measure StewardClaimsCSVRegistryEHRGPRO (WebInterface)Measures GroupsOther QualityReportingPrograms

to remove this measure from 2015 PQRS reporting.

N/A/232 Effective Clinical

Care Asthma: Tobacco Use: Intervention - Ambulatory Care Setting : Percentage of patients aged 5 through 64 years with a diagnosis of asthma who were identified as tobacco users (or their primary caregiver) who received tobacco cessation intervention at least once during the one-year measurement period Commenters disagreed with CMS' proposal to replace PQRS #232 (Asthma: Tobacco Use: Intervention - Ambulatory Care Setting) with PQRS #226 "Preventive Care and Screening: Tobacco Use: Screening and Cessation Intervention" because PQRS #231 and #232 include an age range of 5-64 while the lower bound age for PQRS #226 is 18 years, missing the pediatric population. Furthermore, PQRS #226 does not include the query regarding exposure to second hand smoke which is cri tical for the 18 and under population with Asthma. However, CMS continues to believe #226 is appropriate and more broadly applicable and for this reason is finalizing its proposal to remove #232 from 2015 PQRS reporting. AMAPCPI NCQA X X X

0457/233 Effective Clinical

Care Thoracic Surgery: Recording of Performance Status Prior to Lung or Esophageal Cancer Resection: Percentage of patients aged 18 years and older undergoing resection for lung or esophageal cancer for whom performance status was documented and review ed within 2 weeks prior to surgery Commenters disagreed with removal of this measure noting that removal based on a high-performance rate . With a performance rate above 90 percent for multiple consecutive years, CMS considers the measure to have reached its potential, and no longer represent a clinical performance gap that should be m easured by the PQRS Program. The PQRS will continue to focus on measures with maximal potential for improvement and that answer a clinical performance gap. For this reason, CMS is finalizing its proposal to remove this measure from 2015 PQRS. STS X

0458/234 Patient Safety Thoracic Surgery: Pu lmonary Function Tests Before Major Anatomic Lung Resection (Pneumonectomy, Lobectomy, or Formal Segmentectomy): Percentage of thoracic surgical patients aged 18 years and STS XCMS-1612-FC 757NQF/PQRS NQS Domain Measure Title and Description ¥Measure StewardClaimsCSVRegistryEHRGPRO (WebInterface)Measures GroupsOther QualityReportingPrograms

older undergoing at least one pulmonary function test within 12 months prior to a major lung resection (pneumonectomy, lobectomy, or form al segmentectomy) Commenters disagreed with removal of this measure noting that removal based on a high-performance rate . With a performance rate above 90 percent for multiple consecutive years, CMS considers the measure to have reached its potential, and no longer represent a clinical performance gap that should be m easured by the PQRS Program. The PQRS will continue to focus on measures with maximal potential for improvement and that answer a clinical performance gap. For this reason, CMS is finalizing its proposal to remove this measure from 2015 PQRS.

AQA Adopted

/245 Effective Clinical

Care Chronic Wound Care: Use of Wound Surface Culture Technique in Patients with Chronic Skin Ulcers (Overuse Measure): Percentage of patient visits for those patients aged 18 years and older with a diagnosis of chronic skin ulcer without the use of a wound surface culture technique Commenters disagreed with removal of this measure based on a rationale of high performance rates. With a performance rate above 90 percent for multiple consecutive years, CMS considers the measure to have reached its potential, and no longer represent a clinical performance gap that should be measured by the PQRS Program. The PQRS will con tinue to focus on measures with maximal potential for improvement and that answer a clinical performance gap. However, other commenters supported the removal of this measure. For these reasons, CMS is finalizing its proposal to remove this measure from reporting in 2015 PQRS. ASPS X X

AQA Adopted

/246 Effective Clinical

Care Chronic Wound Care: Use of Wet to Dry Dressings in Patients with Chronic Skin Ulcers (Overuse Measure): Percentage of patient visits for those patients aged 18 years and older with a diagnosis of chronic skin ulcer without a prescription or recommendation to use wet to dry dressings Commenters disagreed with removal of this measure based on a rationale of high performance rates. With a performance rate above 90 percent for multiple consecutive years, CMS considers the measure to have reached its potential, and no longer ASPS X XCMS-1612-FC 758NQF/PQRS NQS Domain Measure Title and Description ¥Measure StewardClaimsCSVRegistryEHRGPRO (WebInterface)Measures GroupsOther QualityReportingPrograms

represent a clinical performance gap that should be measured by the PQRS Program. The PQRS will con tinue to focus on measures with maximal potential for improvement and that answer a clinical performance gap. However, other commenters supported the removal of this measure. For these reasons, CMS is finalizing its proposal to remove this measure from reporting in 2015 PQRS.

AQA Adopted/ 247 Effective Clinical

Care 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 Commenters disagreed with removal of this measure based on a rationale of high performance rates. With a performance rate above 90 percent for multiple consecutive years, CMS considers the measure to have reached its potential, and no longer represent a clinical performance gap that should be measured by the PQRS Program. The PQRS will con tinue to focus on measures with maximal potential for improvement and that answer a clinical performance gap. For this reason, CMS is finalizing its proposal to remove this measure from reporting in 2015 PQRS. APA X X AQA

AQA Adopted/ 248 Effective Clinical

Care 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 One commenter reported this measure is not applicable to nursing home providers. No other comments were received regarding this measure. CMS is finalizing its proposal to remove this measure from reporting in 2015 PQRS. APA X X AQA

N/A /266 Effective Clinical

Care 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 AAN X XCMS-1612-FC 759NQF/PQRS NQS Domain Measure Title and Description ¥Measure StewardClaimsCSVRegistryEHRGPRO (WebInterface)Measures GroupsOther QualityReportingPrograms

record No comments were received regarding this measure. CMS is finalizing its proposal to remove this measure from reporting in 2015 PQRS.

N/A/ 267 Effective Clinical

Care 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 No comments were received regarding this measure. CMS is finalizing its proposal to remove this measure from reporting in 2015 PQRS. AAN X X

N/A/ 269 Effective Clinical

Care 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 One commenter disagreed with the removal of this measure but di d not provide a reason. However, CMS continues to believe that, as a measurement tool, PQRS #269 did not add clinical value to the PQRS Program because in order to provide ca re for IBD patients, documentation of type, anatomic location and activity would be essential for effective treatment of the disease. For this reason, CMS is finalizing its proposal to remove this measure from reporting in 2015 PQRS. AGA X

N/A/ 272 Effective Clinical

Care 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 Commenters were supportive of the removal of this measure and its replacement with PQRS #110 (Preventive Care and Screening: Influenza Immunization) if language were added to the replacement measure to include IBD. CMS continues to believe this measure is duplicative of PQRS #110, which is also more broadly applicable. For this reason, CMS is AGA XCMS-1612-FC 760NQF/PQRS NQS Domain Measure Title and Description ¥Measure StewardClaimsCSVRegistryEHRGPRO (WebInterface)Measures GroupsOther QualityReportingPrograms

finalizing its proposal to remove this measure from reporting in 2015 PQRS and will work with the measure steward to address the question of expanding the age range of PQRS #110.

N/A/ 273 Effective Clinical

Care Inflammatory Bowel Disease (IBD): Preventive Care: Pneumococcal Immunization: Percentage of patients aged 18 years and older with a diagnosis of inflammatory bowel disease that had pneumococcal v accination administered or previously received Commenters were supportive of the removal of this measure and its replacement with PQRS #111 (Pneumonia Vaccination Status for Older Adults) if language were added to the replacement measure to include IBD patients and address age range differences between the two meas ures as PQRS #111 does not address the under 65 population. CMS has confirmed with the measure steward for PQRS #111 that the age range can be adjusted. For this reason, CMS is finalizing its proposal to remove this measure from reporting in 2015 PQRS. AGA X

N/A/295 Effective Clinical

Care Hypertension: Use of Aspirin or Other Antithrombotic Therapy: Percentage of patients aged 30 through 90 years old with a diagnosis of hypertensi on and are eligible for aspirin or other antithrombotic therapy who were prescribed aspirin or other antithrombotic therapy

A steward has not been identified for this measure, and for this reason CMS is finalizing its proposal to remove this measure from reporting in 2015 PQRS. ABIM X

N/A/ 296 Effective Clinical

Care Hypertension: Complete Lipid Profile: Percentage of patients aged 18 through 90 years old with a diagnosis of hypertension who received a complete lipid profile within 60 months

A steward has not been identified for this measure, and for this reason CMS is finalizing its proposal to remove this measure from reporting in 2015 PQRS. ABIM X

N/A/297 Effective Clinical

Care Hypertension: Urine Protein Test: Percentage of patients aged 18 through 90 years old with a diagnosis of hypertension who either have chronic kidney disease diagnosis documented or had a urine protein test done within 36 months. Commenters disagreed with the removal of ABIM XCMS-1612-FC 761NQF/PQRS NQS Domain Measure Title and Description ¥Measure StewardClaimsCSVRegistryEHRGPRO (WebInterface)Measures GroupsOther QualityReportingPrograms

this measure noting th at without it, there will “no longer be a quality measure in PQRS that assesses kidney function for people at high risk of chronic kidney disease.” Unfortunately, these measures cannot remain in the PQRS program without a measure stew ard. Given a steward has not been identified for this measure CMS is finalizing its proposal to remove this measure from reporting in 2015 PQRS.

N/A/298 Effective Clinical

Care Hypertension: Annual Serum Creatinine Test: Percentage of patients aged 18 through 90 years old with a diagnosis of hypertension who had a serum creatinine test done within 12 months

A steward has not been identified for this measure, and for this reason CMS is finalizing its proposal to remove this measure from reporting in 2015 PQRS. ABIM X

N/A/299 Effective Clinical

Care Hypertension: Diabetes Mellitus Screening Test: Percentage of patients aged 18 through 90 years old with a diagnosis of hypertension who had a diabetes screening test within 36 months

A steward has not been identified for this measure, and for this reason CMS is finalizing its proposal to remove this measure from reporting in 2015 PQRS. ABIM X

N/A/300 Effective Clinical

Care Hypertension: Blood Pressure Control: Percentage of patients aged 18 through 90 years old with a diagnosis of hypertension whose most recent blood pressure was under control (< 140/90 mmHg)

A steward has not been identified for this measure, and for this reason CMS is finalizing its proposal to remove this measure from reporting in 2015 PQRS. ABIM X

N/A/ 301 Effective Clinical

Care Hypertension: Low Density Lipoprotein (LDL-C) Control : Percentage of patients aged 18 through 90 years old with a diagnosis of hypertension who had most recent LDL cholesterol level under control (at goal) Commenters disagreed with the proposal to remove this measure “until new measures that are more consistent with new and existing guidelines are put in place to replace it.” However, this measure is nolonger in accordance with new evidencebased clinical guidelines regarding lipid control. CMS understands the commenters’ concerns that removi ng measures may lead ABIM XCMS-1612-FC 762NQF/PQRS NQS Domain Measure Title and Description ¥Measure StewardClaimsCSVRegistryEHRGPRO (WebInterface)Measures GroupsOther QualityReportingPrograms

to program gaps; however, it is a priority for PQRS to ultimately increase the quality of health care and this goal was at the forefront of consideration for the removal of these measures. For this reason, CMS is finalizing its proposal to remove this measure from reporting in 2015 PQRS.

N/A/302 Effective Clinical

Care Hypertension: Dietary and Physical Activity Modificati ons Appropriately Prescribed: Percentage of patients aged 18 through 90 years old with a diagnosis of hypertension who received dietary and physical activity couns eling at least once within 12 months

A steward has not been identified for this measure, and for this reason CMS is finalizing its proposal to remove this measure from reporting in 2015 PQRS. ABIM X

2080/341 Efficiency and Cost Reduction Gap in HIV Medical Visits: Percentage of patients, regardless of age, with a diagnosis of HIV who did not have a medical visit in the last 6 months No comments were received regarding this measure. CMS is finalizing its proposal to remove this measure from reporting in 2015 PQRS. HRSA X X

Measures Not Finalized as Proposed

0087/014 Effective Clinical

Care Age-Related Macular Degeneration (AMD): Dilated Macular Examination: Percentage of patients aged 50 years and older with a diagnos is of age-related macular degeneration (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 Commenters disagreed with removal of this measure, noting that removal based on a “high-performance rate when EP reporting within the PQRS program is low” may not be appropriate. We have also received strong comments and feedback from outside stakeholders that this measure is still relevant to its eligible professionals. Some commenters note that the “high performance rate” may be skewed and not accurately reflect the existing gap addressed by this measure. CMS agrees with commenters and therefore is not finali zing its proposal to remove this measure from 2015 PQRS. However, CMS continues to look for better AAO X XCMS-1612-FC 763NQF/PQRS NQS Domain Measure Title and Description ¥Measure StewardClaimsCSVRegistryEHRGPRO (WebInterface)Measures GroupsOther QualityReportingPrograms

outcome measures, and as such this measure may be considered for removal in a future program year.

0268/021 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 a first OR second generation cephalosporin for antimicrobial prophylaxis Commenters disagreed with CMS’ proposal to remove this meas ure, noting “it is premature to remove a measure based on a high-performance rate when the EP reporting rate within the PQRS program is low.” CMS agrees with commenters that removing this meas ure may negatively impact providers’ ability to report to PQRS and therefore is not finalizing its proposal to remove this measure from 2015 PQRS. However, CMS is finali zing its proposal to remove the Perioperative Care Measure Group, and for this reas on this measure will only be reportable through claims and registry for 2015 PQRS. CMS continues to look for better outcom e measures, and as such this measure may be considered for removal in a future program year. AMAPCPI NCQA X X

0271/022 Patient Safety Perioperative Care: Discontinuation ofProphylactic Parenteral Antibiotics (NonCardiac Procedures): Percentage of noncardiac 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 Some commenters disagreed with CMS’ proposal to remove this measure, noting “disparate practi ce patterns among clinicians when selecting the more appropriate prophylactic antibiotic.” Furthermore, commenters note it might be premature to remove a measure based on a high-performance rate . CMS agrees with commenters and therefore is not finalizing its proposal to remove this measure from 2015 PQRS. However, CMS is finalizing its proposal to remove the Perioperative Care Measure Group, and for this reason this AMAPCPI NCQA X XCMS-1612-FC 764NQF/PQRS NQS Domain Measure Title and Description ¥Measure StewardClaimsCSVRegistryEHRGPRO (WebInterface)Measures GroupsOther QualityReportingPrograms

measure will only be reportable through claims and registry for 2015 PQRS. CMS continues to look for better outcome measures, and as such this measure may be considered for removal in a future program year.

0239/023 Patient Safety Perioperative Care: Venous Thromboembolism (VTE) Prophylaxis (When Indicated in ALL Patients): Percentage of surgical patients aged 18 years and older undergoing procedures for which VTE prophylaxis is indicated in all patients, who had an order for LowMolecular Weight Heparin (LMWH), LowDose Unfractionate d 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 Commenters disagreed with removal of this measure noting that removal based on a high-performance rate . CMS agrees with commenters that removing this measure may negatively impact providers’ ability to report to PQRS and therefore is not finalizing its proposal to remove this measure from 2015 PQRS. However, CMS is finalizing its propos al to remove the Perioperative Care Measure Group, and for this reason this measure will only be reportable through claims and registry for 2015 PQRS. CMS continues to look for better outcome measures, and as such this measure may be considered for removal in a future program year. AMAPCPI NCQA X X

0325/032 Effective Clinical

Care Stroke and Stroke Rehabilitation: Discharged on Antithrombotic Therapy: Percentage of patients aged 18 years and older with a diagnosis of ischemic stroke or transient ischemic attack (TIA) who were prescribed antithrombotic therapy at discharge Some commenters agreed while others disagreed with CMS’ proposal to remove this measure due to this measure representing a clinical concept that is currently included within inpatient standard of care to decrease risk of complications in patients diagnosed with ischemic or intracranial stroke when clinically indicated. CMS agrees with commenters, and for this reason CMS is not finali zing its proposal to remove this measure from reporting for 2015 PQRS. However, CMS continues to look for better outcom e measures, and as AANI X XCMS-1612-FC 765NQF/PQRS NQS Domain Measure Title and Description ¥Measure StewardClaimsCSVRegistryEHRGPRO (WebInterface)Measures GroupsOther QualityReportingPrograms

such this measure may be considered for removal in a future program year.

0241/033 Effective Clinical

Care 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 fi brillation who were prescribed an anticoagulant at discharge Commenters disagreed with CMS' proposal to remove this measures based on the rationale that they represent clinical concepts that are currently included within inpatient standards of care to improve patient outcomes for those diagnosed with ischemic or intracranial stroke when clinically indicated. Commenters maintain that these clinical concepts are appropriate for measurement at the individual physician level in addition to the facility level to help ensure the continuous care of stroke patients. CMS agrees with commenters, and for this reason CMS is not finalizing its proposal to remove this measure from reporting for 2015 PQRS. However, CMS continues to look for better outcome measures, and as such this measure may be considered for removal in a future program year. AANI X

0091/051 Effective Clinical

Care Chronic Obstructive Pulmonary Disease (COPD): Spirometry Evaluation: Percentage of patients aged 18 years and older with a diagnosis of COPD who had spirometry evaluation results documented

A steward has been identified for this measure, and for this reason CMS is not finalizing its proposal to remove this measure from reporting in 2015 PQRS. American Thoracic Society X X

0102/052 Effective Clinical

Care Chronic Obstructive Pulmonary Disease (COPD): Inhaled Bronchodilator Therapy: Percentage of patients aged 18 years and older with a diagnosis of COPD and who have an FEV 1 /FVC less than 60% and have symptoms who were prescribed an inhaled bronchodilator

A steward has been identified for this measure, and for this reason CMS is not finalizing its proposal to remove this measure from reporting in 2015 PQRS. American Thoracic Society X X

0050/109 Person andCaregiverOsteoarthritis (OA): Function and Pain Assessment: Percentage of patient visits for AAOS XCMS-1612-FC 766NQF/PQRS NQS Domain Measure Title and Description ¥Measure StewardClaimsCSVRegistryEHRGPRO (WebInterface)Measures GroupsOther QualityReportingPrograms

Centered Experience and Outcomes patients aged 21 years and older with a diagnosis of osteoarthritis (OA) with assessment for function and pain

A steward has been identified for this measure, and for this reason CMS is not finalizing its proposal to remove this measure from reporting in 2015 PQRS.

0566/140 Effective Clinical

Care Age-Related Macular Degeneration (AMD): Counseling on Antioxidant Supplement: Percentage of patients aged50 years and older with a diagnosis of agerelated macular degeneration (AMD) or their caregiver(s) who were counseled within 12 months on the benefits and/or risks of the Age-Related Eye Disease Study (AREDS) formulation for preventing progression of AMD Commenters disagreed with removal of this measure noting that removal based on a “high-performance rate when EP reporting within the PQRS program is low” may not be appropriate. CMS agrees with commenters, and for this reason CMS is not finalizing its proposal to remove this measure from reporting for 2015 PQRS. However, CMS continues to look for better outcome measures, and as such this measure may be considered for removal in a future program year. AAO X X

0508/146 Efficiency and Cost Reduction Radiology: Inappropriate Use of “Probably Benign” Assessment Category in Mammography Screening: Percentage of final reports for screening mammograms that are classified as “probably benign” Commenters disagreed with the removal of this measure based on a rationale of a high performance rate. Furthermore one commenter notes “this measure is important in that it ensures the integrity of the complete mammography audit.” CMS agrees with commenters, and for this reason CMS is not finalizing its proposal to remove this measure from reporting for 2015 PQRS. However, CMS continues to look for better outcome measures, and as such this measure may be considered for removal in a future program year. AC Radiology

/ AMAPCPI X X

N/A/147 Communic ation and

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 SNMMI X XCMS-1612-FC 767NQF/PQRS NQS Domain Measure Title and Description ¥Measure StewardClaimsCSVRegistryEHRGPRO (WebInterface)Measures GroupsOther QualityReportingPrograms

documentation of correlation with existingrelevant imaging studies (for example, xray, MRI, CT, etc.) that were performed.

A steward has been identified for this measure, and as a result CMS is not finalizing its proposal to remove this measure from reporting in 2015 PQRS.

0115/168 Effective Clinical

Care 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 hospitalizati on for mediastinal bleeding with or without tamponade, graft occlusion, valve dysfunction, or other cardiac reason Commenters disagreed with removal of this measure noting that removal based on a high-performance rate . CMS agrees with commenters that this may negatively impact the ability of certain specialties to report PQRS, and for this reason CMS is not finalizing its proposal to remove this measure from reporting for 2015 PQRS. However, CMS continues to look for better outcome measures, and as such this measure may be considered for removal in a future program year. STS X X

AQA Adopted/ 173 Community /Population

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 measure steward has been identified for this measure, and as such CMS is not finalizing its proposal to remove this measure from reporting in 2015 PQRS. AMAPCPI

X X

0643/243 Effective Clinical

Care Cardiac Rehabilitation Patient Referral from an Outpatient Setting: Percentage of patients evaluated in an outpatient setting who within the previous 12 months have experienced an 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/seconda ry prevention (CR) program for the qualifyi ng event/diagnosis who were referred to a CR program ACCF AHA XCMS-1612-FC 768NQF/PQRS NQS Domain Measure Title and Description ¥Measure StewardClaimsCSVRegistryEHRGPRO (WebInterface)Measures GroupsOther QualityReportingPrograms

Commenters disagreed with CMS' proposal to remove this meas ure, suggesting that “while the clinical c ondition may initiate in the inpatient setting, the clinical process being measured is limited to the outpatient setting and would therefore add clinical value to outpatient care of the cardiac rehabilitation patient. ” Further, commenters note that there is “clear evidence that processes to improve referral of eligible patients to cardiac rehabilitation result in improved cardiac rehabilitation participation rates and improved patient outcomes.” CMS agrees with the commenters, and for this reason CMS is not finali zing its proposal to remove this measure from reporting for 2015 PQRS. However, CMS continues to look for better outcom e measures, and as such this measure may be considered for removal in a future program year.

N/A/ 257 Effective Clinical

Care Statin Therapy at Discharge after Lower Extremity Bypass (LEB): Percentage of patients aged 18 years and older undergoing infra-inguinal lower extremity bypass who are prescribed a statin medication at discharge Commenters disagreed with the proposed removal of this measure on the basis that the measure represents a current standard of care. CMS agrees with commenters, and for this reason CMS is not finalizing its proposal to remove this measure from reporting for 2015 PQRS. However, CMS continues to look for better outcome measures, and as such this measure may be considered for removal in a future program year. SVS X

N/A/ 261 Communic ation and

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 Commenters disagreed with CMS' proposal to remove this measure with the rationale that it represents a clinical concept that is common practice in order to provide effective treatment for patients. Commenters request reconsideration for CY 2015 to ensure audiologists have enough clinically-relevant measures to report. For this reason, CMS is not finalizing its proposal to remove this measure from AQC X XCMS-1612-FC 769NQF/PQRS NQS Domain Measure Title and Description ¥Measure StewardClaimsCSVRegistryEHRGPRO (WebInterface)Measures GroupsOther QualityReportingPrograms

reporting in 2015 PQRS.

N/A/276 Effective Clinical

Care 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 sleep symptoms, including presence or absence of snoring and daytime sleepiness

A steward has been identified for this measure and for this reason CMS is not finalizing its proposal to remove this measure from reporting in 2015 PQRS. AASM/AMAPCPI X

N/A/277 Effective Clinical

Care 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 (RD I) measured at the time of initia l diagnosis

A steward has been identified for this measure, and for this reason CMS is not finalizing its proposal to remove this measure from reporting in 2015 PQRS. AASM/AMAPCPI X

N/A/278 Effective Clinical

Care 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

A steward has been identified for this measure, and for this reason CMS is not finalizing its proposal to remove this measure from reporting in 2015 PQRS. AASM/AMAPCPI X

N/A/279 Effective Clinical

Care 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 steward has been identified for this measure, and for this reason CMS is not finalizing its proposal to remove this measure from reporting in 2015 PQRS. AASM/AMAPCPI X

N/A/335 Patient Safety Maternity Care: Elective Delivery or Early Induction Without Medical Indication at ≥ 37 and < 39 Weeks: Percentage of patients, regardless of age, who gave birth during a 12-month period who delivered a live singleton at ≥ 37 and < AMAPCPI XCMS-1612-FC 770NQF/PQRS NQS Domain Measure Title and Description ¥Measure StewardClaimsCSVRegistryEHRGPRO (WebInterface)Measures GroupsOther QualityReportingPrograms

39 weeks of gestation completed who had elective deliveries or early inductions without medical indication

A steward has been identified for this measure, and for this reason CMS is not finalizing its proposal to remove this measure from reporting in 2015 PQRS.

N/A/336 Communic ation and

Care Coordinatio n Maternity Care: Pos t-Partum Follow-Up and Care Coordination: Percentage of patients, regardless of age, who gave birth during a 12-month period who were seen for post-partum care within 8 weeks of giving birth who received a breast feeding evaluation and educat ion, post-partum depression screening, post-partum glucose screening for gestational diabetes patients, and family and contraceptive planning

A steward has been identified for this measure, and for this reason CMS is not finalizing its proposal to remove this measure from reporting in 2015 PQRS. AMAPCPI X

¥ Measure details including titles, descriptions and meas ure owner information may vary during a particular program year. This is due to the timi ng of measure specification preparation and the measure versions used by the various reporting options/methods. Please refer to the me asure specifications that a pply for each of the reporting options/methods for specific measure details. In Table 56, we provide our responses and final d ecisions related to our proposals to change the way in which previously established measures in th e PQRS will be reported be ginning in 2015 (79 FR 40441).CMS-1612-FC 771

TABLE 56: Existing Individual Quality Measures and Those Included in Measures Groups for the PQRS for Which Measure Reporting Updates Will Be Effective Beginning in 2015NQF/PQRSCMSE-Measure ID National Quality Strategy Domain Measure Title and Description ¥Measure StewardClaimsCSVRegistryEHRGPRO (WebInterface)MeasuresGroupsOther QualityReportingPrograms

Measures Finalized as Proposed

006 4/0 02 163 v3 Effective Clinical

Care Diabetes: Low Density Lipoprotein (LDLC) Control (<100 mg/Dl: Percentage of patients 18–75 years of age with diabetes whose LDL-C was adequately controlled (< 100 mg/dL) during the measurement period Commenters expressed concern with maintaining this measure in PQRS for EHR reporting only for the “sake of alignment with the EHR Incentive Program especially in the face of changing [clinical] evidence.” However, due to our desire to align with the EHR Incentive Program, CMS will not make changes to EHR measures until the EHR Incentive Program is able to change this measure. CMS understands commenters’ concerns and will track these issues for future program years when changes are possible. CMS is finalizing its proposal to make this measure reportable in 2015 PQRS through EHR only. NCQA X MU2 Million Hearts

006 7/0 06 Effective Clinical

Care Coronary Artery Disease (CAD): Antiplatelet Therapy: Percentage of patients aged 18 years and older with a diagnosis of coronary artery disease (CAD) seen within a 12 month period who were prescribed aspirin or clopidogrel

Several commenters were concerned with CMS’ proposal to elimin ate the claims-based reporting option for various measures, noting that not all eligible professionals have the resources to implement registry or EHR reporting and will no longer be able to participate in PQRS. CMS appreciates the commenters’ concerns and believes that removal of the claims-based reporting option will not negatively impact a significant number of providers reporting these measures. CMS also received comments supporting inclusion of the measure in the Shared Savings Program CAD Composite measure but with com posite measure testing and NQF review. Therefore, CMS isfinalizing its proposal to remove the claimsbased reporting option for this measure in 2015 PQRS as part of its goal to lower the data error rate and decrease provider burden. CMS will not finalize adding this measure in the Shared Savings Program CAD Composite. AMAPCPI ACCF AHA X X X ACO

010 5/0 128 v3 Effective Clinical Anti-Depressant Medication Management: Percentage of patients 18 years of age and NCQA X MU2CMS-1612-FC 772NQF/PQRSCMSE-Measure ID National Quality Strategy Domain Measure Title and Description ¥Measure StewardClaimsCSVRegistryEHRGPRO (WebInterface)MeasuresGroupsOther QualityReportingPrograms

09 Care older who were diagnosed with major depression and treated with antidepressant medication, and who remained on antidepressant medication treatment. Two rates are reported: a. Percentage of patients who remained on an antidepressant medication for at least 84 days (12 weeks). b. Percentage of patien ts who remained on an antidepressant medication for at least 180 days (6 months). CMS is finalizing its proposal to change the reporting option of PQRS #9 to EHR-only reporting as part of its efforts to align with the EHR Incentive Program. PQRS would otherwise propose to remove this measure from PQRS, as it is a process measure that is analytically challenging to report.

008 8/0 18 167 v3 Effective Clinical

Care 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 macu lar or fundus exam performed which included documentation of the level of severity of retinopathy and the presence or absence of macular edema during one or more office vis its within 12 months One commenter disagreed with the removal of this measure. CMS initially wanted to propose removal of this measure as eligible professionals are consistently meeting performance on this measure with performance rates close to 100%. However, due to our desire to align with the EHR Incentive Program, under which this measure is also available for reporting in 2015, CMS proposed to maintain th is measure in PQRS for EHR reporting only, removing all other reporting options, until the EHR Incentive Program can change this measure. CMS is finalizing removal of this measure from reporting for 2015 PQRS for all other reporting options. AMAPCPI NCQA X MU2

013 4/0 43 Effective Clinical

Care Coronary Artery Bypass Graft (CABG): Use of Internal Mammary Artery (IMA) in Patients with Isolated CABG Surgery: Percentage of patients aged 18 years and older undergoing isolated CABG surgery who received an IMA graft

Several commenters were concerned with CMS’ proposal to elimin ate the claims-based reporting option for various measures, noting that not all eligible professionals have the STS X XCMS-1612-FC 773NQF/PQRSCMSE-Measure ID National Quality Strategy Domain Measure Title and Description ¥Measure StewardClaimsCSVRegistryEHRGPRO (WebInterface)MeasuresGroupsOther QualityReportingPrograms

resources to implement registry or EHR reporting and will no longer be able to participate in PQRS. CMS appreciates the commenters’ concerns and believes that removal of the claims-based reporting option will not negatively impact a significant number of providers reporting these measures. Therefore, CMS is finalizing its proposal to remove the claims-based reporting option for this measure in 2015 PQRS as part of its goal to lower the data error rate and decrease provider burden.

037 7/0 67 Effective Clinical

Care Hematology: Myelodysplastic Syndrome (MDS) and Acute Leukemias: Baseline Cytogenetic Testing Performed on Bone Marrow: Percentage of patients aged 18 years and older with a diagnosis of myelodysplastic syndrome (MDS) or an acute leukemia who had baseline cytogenetic testing performed on bone marrow

Several commenters were concerned with CMS’ proposal to elimin ate the claims-based reporting option for various measures, noting that not all eligible professionals have the resources to implement registry or EHR reporting and will no longer be able to participate in PQRS. CMS appreciates the commenters’ concerns and believes that removal of the claims-based reporting option will not negatively impact a significant number of providers reporting these measures. Therefore, CMS is finalizing its proposal to remove the claims-based reporting option for this measure in 2015 PQRS as part of its goal to lower the data error rate and decrease provider burden. AMAPCPI ASH X

037 8/0 68 Effective Clinical

Care 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 myelodysplastic syndrome (MDS) who are receiving erythropoietin therapy with documentation of iron stores within 60 days prior to initiating erythropoietin therapy

Several commenters were concerned with CMS’ proposal to elimin ate the claims-based reporting option for various measures, noting that not all eligible professionals have the resources to implement registry or EHR reporting and will no longer be able to participate in PQRS. CMS appreciates the commenters’ concerns and believes that removal of the claims-based reporting option will not negatively impact a significant AMAPCPI ASH XCMS-1612-FC 774NQF/PQRSCMSE-Measure ID National Quality Strategy Domain Measure Title and Description ¥Measure StewardClaimsCSVRegistryEHRGPRO (WebInterface)MeasuresGroupsOther QualityReportingPrograms

number of providers reporting these measures. Therefore, CMS is finalizing its proposal to remove the claims-based reporting option for this measure in 2015.

038 0/0 69 Effective Clinical

Care Hematology: Multiple Myeloma: Treatment with Bisphosphonates: Percentage of patients aged 18 years and older with a diagnosis of multiple myeloma, not in remission, who were prescribed or received intravenous bisphosphonate therapy within the 12-month reporting period

Several commenters were concerned with CMS’ proposal to elimin ate the claims-based reporting option for various measures, noting that not all eligible professionals have the resources to implement registry or EHR reporting and will no longer be able to participate in PQRS. CMS appreciates the commenters’ concerns and believes that removal of the claims-based reporting option will not negatively impact a significant number of providers reporting these measures. Therefore, CMS is finalizing its proposal to remove the claims-based reporting option for this measure in 2015. AMAPCPI ASH X

037 9/0 70 Effective Clinical

Care Hematology: Chronic Lymphocytic Leukemia (CLL): Baseline Flow Cytometry: Percentage of patients aged 18 years and older seen within a 12 month reporting period with a diagnosis of chronic lymphocytic leukemia (CLL) made at any time during or prior to the reporting period who had baseline flow cytometry studies performed and documented in the chart

Several commenters were concerned with CMS’ proposal to elimin ate the claims-based reporting option for various measures, noting that not all eligible professionals have the resources to implement registry or EHR reporting and will no longer be able to participate in PQRS. CMS appreciates the commenters’ concerns and believes that removal of the claims-based reporting option will not negatively impact a significant number of providers reporting these measures. Therefore, CMS is finalizing its proposal to remove the claims-based reporting option for this measure in 2015. AMAPCPI ASH X

039

5 /08 4 Effective Clinical

Care Hepatitis C: Ribonuc leic Acid (RNA) Testing Before Initiating Treatment: Percentage of patients aged 18 years and older with a diagnosis of chronic hepatitis C who started antiviral treatment within the 12 month reporting period for whom quantitative hepatitis C virus (HCV) RNA AGA XCMS-1612-FC 775NQF/PQRSCMSE-Measure ID National Quality Strategy Domain Measure Title and Description ¥Measure StewardClaimsCSVRegistryEHRGPRO (WebInterface)MeasuresGroupsOther QualityReportingPrograms

testing was performed within 12 months prior to initiation of antiviral treatment

While several comments were concerned with the removal of reporting options for some measures, CMS is finalizing its proposal to make this individual measure reportable via measures groups-only to lessen the burden of eligible professionals reporting individual measures based on the current requirement of nine measures over three domains. While removing reporting options could be seen as increasing burden for eligible professionals, as they have fewer choices to report this measure, we do not believe this is the case with reporting via measures groups. For ex ample, an individual eligible professional re porting via a measures group only need to report on a minimum of 6 measures rather than a minimum of 9 measures covering 3 NQS domains, as is the case with reporting i ndividual measures.

039

6 /08 5 Effective Clinical

Care Hepatitis C: HCV Genotype Testing Prior to Treatment: Percentage of patients aged 18 years and older with a diagnosis of chronic hepatitis C who started antiviral treatment within the 12 month reporting period for whom hepa titis C virus (HCV) genotype testing was performed within 12 months prior to initiation of antiviral treatment

While several comments were concerned with the removal of reporting options for some measures, CMS is finalizing its proposal to make this individual measure reportable via measures groups-only to lessen the burden of eligible professionals reporting individual measures based on the current requirement of nine measures over three domains. While removi ng reporting options could be seen as increasing burden for eligible professionals, as they have fewer choices to report this measure, we do not believe this is the case with reporting via measures groups. For ex ample, an individual eligible professional re porting via a measures group only need to report on a minimum of 6 measures rather than a minimum of 9 measures covering 3 NQS domains, as is the case with reporting i ndividual measures AGA X

039 8/0 87 Effective Clinical

Care Hepatitis C: Hepati tis C Virus (HCV) Ribonucleic Acid ( RNA) Testing Between 4-12 Weeks After Initiation of Treatment: Percentage of patients aged 18 years and older with a diagnosis of chronic hepatitis C who are receiving antiviral treatment for AGA XCMS-1612-FC 776NQF/PQRSCMSE-Measure ID National Quality Strategy Domain Measure Title and Description ¥Measure StewardClaimsCSVRegistryEHRGPRO (WebInterface)MeasuresGroupsOther QualityReportingPrograms

whom quantitative hepatitis C virus (HCV) RNA testing was performed between 4-12 weeks after the initiation of antiviral treatment

While several comments were concerned with the removal of reporting options for some measures, CMS is finalizing its proposal to make this individual measure reportable via measures groups-only to lessen the burden of eligible professionals reporting individual measures based on the current requirement of nine measures over three domains. While removi ng reporting options could be seen as increasing burden for eligible professionals, as they have fewer choices to report this measure, we do not believe this is the case with reporting via measures groups. For ex ample, an individual eligible professional re porting via a measures group only need to report on a minimum of 6 measures rather than a minimum of 9 measures covering 3 NQS domains, as is the case with reporting i ndividual measures

038

9 /10 2 129 v3 Efficiency and Cost Reduction 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

Several commenters were concerned with CMS’ proposal to elimin ate the claims-based reporting option for various measures, noting that not all eligible professionals have the resources to implement registry or EHR reporting and will no longer be able to participate in PQRS. CMS appreciates the commenters’ concerns and believes that removal of the claims-based reporting option will not negatively impact a significant number of providers reporting these measures. Therefore, CMS is finalizing its proposal to remove the claims-based reporting option for this measure in 2015. AMAPCPI X X MU2

039

0 /10 4 Effective Clinical

Care 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 or very high risk of recurrence receiving external beam radiotherapy to the prostate who were prescribed adjuvant hormonal therapy (GnRH [gonadotropin-releasing AMAPCPI XCMS-1612-FC 777NQF/PQRSCMSE-Measure ID National Quality Strategy Domain Measure Title and Description ¥Measure StewardClaimsCSVRegistryEHRGPRO (WebInterface)MeasuresGroupsOther QualityReportingPrograms

hormone] agonist or antagonist)

Several commenters were concerned with CMS’ proposal to elimin ate the claims-based reporting option for various measures, noting that not all eligible professionals have the resources to implement registry or EHR reporting and will no longer be able to participate in PQRS. CMS appreciates the commenters’ concerns and believes that removal of the claims-based reporting option will not negatively impact a significant number of providers reporting these measures. Therefore, CMS is finalizing its proposal to remove the claims-based reporting option for this measure in 2015.

010 4/1 07 161 v3 Effective Clinical

Care Adult Major Depressive Disorder (MDD): Suicide Risk Assessment: Percentage of patients aged 18 years and older with a diagnosis of major depressive disorder (MDD) with a suicide risk assessment completed during the visit in which a new diagnosis or recurrent episode was identified CMS is finalizing its proposal to change the reporting option of PQRS #107 to EHR-only reporting as part of its efforts to align with the EHR Incentive Program when PQRS would otherwise propose to remove this measure from PQRS, as it is a process measure that is analytically challenging to report. PQRS will keep this measure as EHRreportable until the EHR Incentive Program is able to change this measure. AMAPCPI X MU2

005

4 /10

8 Effective Clinical

Care 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 ambulatoryprescription for a disease-modifying antirheumatic drug (DMARD)

While several comments were concerned with the removal of reporting options for some measures, CMS is finalizing its proposal to make this individual measure reportable via measures groups-only to lessen the burden of eligible professionals reporting individual measures based on the current requirement of nine measures over three domains. While removi ng reporting options could be seen as increasing burden for eligible professionals, as they have fewer choices to report this measure, we do not believe this is the case with reporting via measures groups. For ex ample, an individual NCQA XCMS-1612-FC 778NQF/PQRSCMSE-Measure ID National Quality Strategy Domain Measure Title and Description ¥Measure StewardClaimsCSVRegistryEHRGPRO (WebInterface)MeasuresGroupsOther QualityReportingPrograms

eligible professional re porting via a measures group only need to report on a minimum of 6 measures rather than a minimum of 9 measures covering 3 NQS domains, as is the case with reporting i ndividual measures

166 8 /12

1 Effective Clinical

Care Adult Kidney Disease: Laboratory Testing (Lipid Profile): Percentage of patients aged 18 years and older with a diagnosis of chronic kidney disease (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

Several commenters were concerned with CMS’ proposal to elimin ate the claims-based reporting option for various measures, noting that not all eligible professionals have the resources to implement registry or EHR reporting and will no longer be able to participate in PQRS. CMS appreciates the commenters’ concerns and believes that removal of the claims-based reporting option will not negatively impact a significant number of providers reporting these measures. Therefore, CMS is finalizing its proposal to remove the claims-based reporting option for this measure in 2015. RPA X X

AQ A Ad opt ed /12 2 Effective Clinical

Care Adult Kidney Disease: Blood Pressure Management: Percentage of patient visits for those patients aged 18 years and older with a diagnosis of chronic kidney disease (CKD) (stage 3, 4, or 5, not receiving Renal Replacement Therapy [RRT]) with a blood pressure < 140/90 mmHg OR ≥ 140/90 mmHg with a documented plan of care

Several commenters were concerned with CMS’ proposal to elimin ate the claims-based reporting option for various measures, noting that not all eligible professionals have the resources to implement registry or EHR reporting and will no longer be able to participate in PQRS. CMS appreciates the commenters’ concerns and believes that removal of the claims-based reporting option will not negatively impact a significant number of providers reporting these measures. Therefore, CMS is finalizing its proposal to remove the claims-based reporting option for this measure in 2015. RPA X X AQA

040

5 /16 0 52v 3 Effective Clinical

Care HIV/AIDS: Pneumocystis Jiroveci Pneumonia (PCP) Prophylaxis: Percentage of patients aged 6 weeks and older with a diagnosis of HIV/AIDS who were prescribed Pneumocystis Jiroveci Pneumonia (PCP) prophylaxis NCQA X MU2CMS-1612-FC 779NQF/PQRSCMSE-Measure ID National Quality Strategy Domain Measure Title and Description ¥Measure StewardClaimsCSVRegistryEHRGPRO (WebInterface)MeasuresGroupsOther QualityReportingPrograms

While several comments were concerned with the removal of reporting options for some measures, CMS is finalizing its proposal to make this individual measure reportable via measures groups-only to lessen the burden of eligible professionals reporting individual measures based on the current requirement of nine measures over three domains. While removi ng reporting options could be seen as increasing burden for eligible professionals, as they have fewer choices to report this measure, we do not believe this is the case with reporting via measures groups. For ex ample, an individual eligible professional re porting via a measures group only need to report on a minimum of 6 measures rather than a minimum of 9 measures covering 3 NQS domains, as is the case with reporting i ndividual measures

AQ A Ad opt ed/ 176 Effective Clinical

Care Rheumatoid Arthritis (RA): Tuberculosis Screening: Percentage of patients aged 18 years and older with a diagnosis of rheumatoid arthritis (RA) who have documentation of a tuberculosis (TB) screening performed and results interpreted within 6 months prior to receiving a firstcourse of therapy using a biologic diseasemodifying anti-rheumatic drug (DMARD)

While several comments were concerned with the removal of reporting options for some measures, CMS is finalizing its proposal to make this individual measure reportable via measures groups-only to lessen the burden of eligible professionals reporting individual measures based on the current requirement of nine measures over three domains. While removi ng reporting options could be seen as increasing burden for eligible professionals, as they have fewer choices to report this measure, we do not believe this is the case with reporting via measures groups. For ex ample, an individual eligible professional re porting via a measures group only need to report on a minimum of 6 measures rather than a minimum of 9 measures covering 3 NQS domains, as is the case with reporting i ndividual measures AC Rheumat

ology X AQA

AQ A Ad opt ed/ 177 Effective Clinical

Care Rheumatoid Arthriti s (RA): Periodic Assessment of Disease Activity: Percentage of patients aged 18 years and older with a diagnosis of rheumatoid arthritis (RA) who have an assessment a nd classification of disease activity within 12 months

While several comments were concerned AC Rheumat

ology X AQACMS-1612-FC 780NQF/PQRSCMSE-Measure ID National Quality Strategy Domain Measure Title and Description ¥Measure StewardClaimsCSVRegistryEHRGPRO (WebInterface)MeasuresGroupsOther QualityReportingPrograms

with the removal of reporting options for some measures, CMS is finalizing its proposal to make this individual measure reportable via measures groups-only to lessen the burden of eligible professionals reporting individual measures based on the current requirement of nine measures over three domains. While removi ng reporting options could be seen as increasing burden for eligible professionals, as they have fewer choices to report this measure, we do not believe this is the case with reporting via measures groups. For ex ample, an individual eligible professional re porting via a measures group only need to report on a minimum of 6 measures rather than a minimum of 9 measures covering 3 NQS domains, as is the case with reporting i ndividual measures

AQ A Ad opt ed/ 179 Effective Clinical

Care Rheumatoid Arthritis (RA): Assessment and Classification of Disease Prognosis: Percentage of patients aged 18 years and older with a diagnosis of rheumatoid arthritis (RA) who have an assessment and classification of dis ease prognosis at least once within 12 months

While several comments were concerned with the removal of reporting options for some measures, CMS is finalizing its proposal to make this individual measure reportable via measures groups-only to lessen the burden of eligible professionals reporting individual measures based on the current requirement of nine measures over three domains. While removi ng reporting options could be seen as increasing burden for eligible professionals, as they have fewer choices to report this measure, we do not believe this is the case with reporting via measures groups. For ex ample, an individual eligible professional re porting via a measures group only need to report on a minimum of 6 measures rather than a minimum of 9 measures covering 3 NQS domains, as is the case with reporting i ndividual measures AC Rheumat

ology X AQA

AQ A Ad opt ed /18 0 Effective Clinical

Care Rheumatoid Arthritis (RA): Glucocorticoid Management: Percentage of patients aged 18 years and older with a diagnosis of rheumatoid arthritis (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

While several comments were concerned AC Rheumat

ology X AQACMS-1612-FC 781NQF/PQRSCMSE-Measure ID National Quality Strategy Domain Measure Title and Description ¥Measure StewardClaimsCSVRegistryEHRGPRO (WebInterface)MeasuresGroupsOther QualityReportingPrograms

with the removal of reporting options for some measures, CMS is finalizing its proposal to make this individual measure reportable via measures groups-only to lessen the burden of eligible professionals reporting individual measures based on the current requirement of nine measures over three domains. While removi ng reporting options could be seen as increasing burden for eligible professionals, as they have fewer choices to report this measure, we do not believe this is the case with reporting via measures groups. For ex ample, an individual eligible professional re porting via a measures group only need to report on a minimum of 6 measures rather than a minimum of 9 measures covering 3 NQS domains, as is the case with reporting i ndividual measures

039

9 /18 3 Community / Population

Health Hepatitis C: Hepatitis A Vaccination in Patients with Hepatitis C Virus (HCV): Percentage of patients aged 18 years and older with a diagnosis of chronic hepatitis C who have received at least one injection of hepatitis A vaccine, or who have documented immunity to hepatitis A

While several comments were concerned with the removal of reporting options for some measures, CMS is finalizing its proposal to make this individual measure reportable via measures groups-only to lessen the burden of eligible professionals reporting individual measures based on the current requirement of nine measures over three domains. While removi ng reporting options could be seen as increasing burden for eligible professionals, as they have fewer choices to report this measure, we do not believe this is the case with reporting via measures groups. For ex ample, an individual eligible professional re porting via a measures group only need to report on a minimum of 6 measures rather than a minimum of 9 measures covering 3 NQS domains, as is the case with reporting i ndividual measures AGA X

038

6 /19 4 Effective Clinical

Care Oncology: Cancer Stage Documented: Percentage of patients, regardless of age, with a diagnosis of can cer who are seen in the ambulatory setting who have a baseline American Joint Committee on Cancer (AJCC) cancer stage or documentation that the cancer is metastatic in the medical record at least once during the 12 month reporting period

Several commenters were concerned with CMS’ proposal to elimin ate the claims-based AMAPCPI ASCO XCMS-1612-FC 782NQF/PQRSCMSE-Measure ID National Quality Strategy Domain Measure Title and Description ¥Measure StewardClaimsCSVRegistryEHRGPRO (WebInterface)MeasuresGroupsOther QualityReportingPrograms

reporting option for various measures, noting that not all eligible professionals have the resources to implement registry or EHR reporting and will no longer be able to participate in PQRS. CMS appreciates the commenters’ concerns and believes that removal of the claims-based reporting option will not negatively impact a significant number of providers reporting these measures. Therefore, CMS is finalizing its proposal to remove the claims-based reporting option for this measure in 2015 PQRS as part of its goal to lower the data error rate and decrease provider burden. Note that this measure is no longer part of a measures group as well.

002 2/2 38 156 v3 Patient Safety Use of High-Risk Medications in the Elderly: Percentage of patients 66 years of age and older who were ordered high-risk medications. Two rates are reported a. Percentage of patien ts who were ordered at least one high-risk medication. b. Percentage of patien ts who were ordered at least two different high-risk medications No comments were received regarding this measure. CMS is finalizing its proposal to add registry as a reporting option for this measure in 2015 PQRS. NCQA X X MU2

007 5/2 41 182 v4 Effective Clinical

Care Ischemic Vascular Disease (IVD): Complete Lipid Profile and LDL-C Control (<100 mg/dL): 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 coronary interventions (PCI) in the 12 months prior to the measurement period, or who had an active diagnosis of isch emic vascular disease (IVD) during the measurement period, and who had each of the following during the measurement period: a complete lipid profile and LDL-C was adequately controlled (< 100 mg/dL) CMS is finalizing its proposal to change the reporting option of PQRS #241 to EHR-only reporting as part of its efforts to align with the EHR Incentive Program when PQRS would otherwise propose to remove this measure from PQRS 2015. PQRS will keep this measure as EHR reportable until the EHR Incentive Program can change this measure. NCQA X MU2 Million Hearts

N/ A /32 Effective Clinical

Care Pediatric Kidney Disease: Adequacy of Volume Management: Percentage of calendar months within a 12-month period RPA XCMS-1612-FC 783NQF/PQRSCMSE-Measure ID National Quality Strategy Domain Measure Title and Description ¥Measure StewardClaimsCSVRegistryEHRGPRO (WebInterface)MeasuresGroupsOther QualityReportingPrograms

7 during which patients aged 17 years and younger with a diagnosis of End Stage Renal Disease (ESRD) undergoing maintenance hemodialysis in an outpa tient dialysis facility have an assessment of the adequacy of volume management from a nephrologist

Several commenters were concerned with CMS’ proposal to elimin ate the claims-based reporting option for various measures, noting that not all eligible professionals have the resources to implement registry or EHR reporting and will no longer be able to participate in PQRS. CMS appreciates the commenters’ concerns and believes that removal of the claims-based reporting option will not negatively impact a significant number of providers reporting these measures. Therefore, CMS is finalizing its proposal to remove the claims-based reporting option for this measure in 2015 PQRS as part of its goal to lower the data error rate and decrease provider burden.

166 7 /32

8 Effective Clinical

Care 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 End Stage Renal Disease (ESRD) receiving hemodi alysis or peritoneal dialysis have a hemoglobin level < 10 g/dL

Several commenters were concerned with CMS’ proposal to elimin ate the claims-based reporting option for various measures, noting that not all eligible professionals have the resources to implement registry or EHR reporting and will no longer be able to participate in PQRS. CMS appreciates the commenters’ concerns and believes that removal of the claims-based reporting option will not negatively impact a significant number of providers reporting these measures. Therefore, CMS is finalizing its proposal to remove the claims-based reporting option for this measure in 2015. RPA X

208

2 /33

8 Effective Clinical

Care HIV Viral Load Suppression: The percentage of patients, regardless of age, with a diagnosis of HIV with a HIV viral load less than 200 copies/mL at last viral load test during the measurement year

While several comments were concerned with the removal of reporting options for some measures, CMS is finalizing its proposal to make this individual measure reportable via measures groups-only to lessen HRSA XCMS-1612-FC 784NQF/PQRSCMSE-Measure ID National Quality Strategy Domain Measure Title and Description ¥Measure StewardClaimsCSVRegistryEHRGPRO (WebInterface)MeasuresGroupsOther QualityReportingPrograms

the burden of eligible professionals reporting individual measures based on the current requirement of nine measures over three domains. While removi ng reporting options could be seen as increasing burden for eligible professionals, as they have fewer choices to report this measure, we do not believe this is the case with reporting via measures groups. For ex ample, an individual eligible professional re porting via a measures group only need to report on a minimum of 6 measures rather than a minimum of 9 measures covering 3 NQS domains, as is the case with reporting i ndividual measures

208

3 /33 9 Effective Clinical

Care Prescription of HIV Antiretroviral Therapy: Percentage of patients, regardless of age, with a diagnosis of HIV prescribed antiretroviral therapy for the treatment of HIV infection during the measurement year

While several comments were concerned with the removal of reporting options for some measures, CMS is finalizing its proposal to make this individual measure reportable via measures groups-only to lessen the burden of eligible professionals reporting individual measures based on the current requirement of nine measures over three domains. While removi ng reporting options could be seen as increasing burden for eligible professionals, as they have fewer choices to report this measure, we do not believe this is the case with reporting via measures groups. For ex ample, an individual eligible professional re porting via a measures group only need to report on a minimum of 6 measures rather than a minimum of 9 measures covering 3 NQS domains, as is the case with reporting i ndividual measures HRSA X

207

9 /34 0 Efficiency and Cost Reduction HIV Medical Visit Frequency: Percentage of patients, regardless of age with a diagnosis of HIV who had at least one medical visit in each 6 month period of the 24 month measurement period, with a minimum of 60 days between medical visits

This measure was included on this table in error in the proposed rule. There are no changes proposed for this measure in 2015 PQRS. This measure was reportable through measure groups only in PQRS 2014 and will continue to be similarly reportable in PQRS 2015. HRSA X

071 0/ 370 159 v3 Effective Clinical

Care 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 MNCM X X MU2CMS-1612-FC 785NQF/PQRSCMSE-Measure ID National Quality Strategy Domain Measure Title and Description ¥Measure StewardClaimsCSVRegistryEHRGPRO (WebInterface)MeasuresGroupsOther QualityReportingPrograms

twelve months defined as PHQ-9 score less than 5. This measure applies to both patients with newly diagnos ed and existing depression whose current PHQ-9 score indicates a need for treatment CMS did not receive any comments regarding the proposal to add registry as a reporting option for this measure. As such, CMS is finalizing this proposal for 2015 PQRS. Measures Not Finalized as Proposed

008 6/0 12 143 v3 Effective Clinical

Care Primary Open-Angle Glaucoma (POAG): Optic Nerve Evaluation: Percentage of patients aged 18 years and older with a diagnosis of primary open-angle glaucoma (POAG) who have an optic nerve head evaluation during one or more office visits within 12 months

Several commenters were concerned with CMS’ proposal to elimin ate the claims-based reporting option for various measures, noting that eligible professionals who may have reported on these measures do not have the resources to implement registry or EHR reporting and will no longer be able to participate in PQRS. Upon further review, CMS agrees that a significant number of providers that report th is measure will be negatively impacted by the removal of the claims-based option. Therefore, CMS is notfinalizing its proposal to remove the claimsbased reporting option for this measure in 2015 PQRS. However, CMS is moving away from claims-based measures and therefore may reconsider the reporting options for this measure in future program years. AMAPCPI NCQA X X X MU2

008 9/0 19 142 v3 Effective Clinical

Care Diabetic Retinopathy: Communication with the Physician Managing Ongoing Diabetes Care: Percentage of patients aged 18 years and older with a diagnosis of diabetic retinopathy who had a dilated macular or fundus exam performed with documented communication to the physician who manages the ongoing care of the patient with diabetes mellitus regarding the findings of the macular or fundus exam at least once within 12 months

Several commenters were concerned with CMS’ proposal to elimin ate the claims-based reporting option for various measures, noting that eligible professionals who may have reported on these measures do not have the resources to implement registry or EHR reporting and will no longer be able to AMAPCPI NCQA X X X MU2CMS-1612-FC 786NQF/PQRSCMSE-Measure ID National Quality Strategy Domain Measure Title and Description ¥Measure StewardClaimsCSVRegistryEHRGPRO (WebInterface)MeasuresGroupsOther QualityReportingPrograms

participate in PQRS. Upon further review, CMS agrees that a significant number of providers that report th is measure will be negatively impacted by the removal of the claims-based option. Therefore, CMS is notfinalizing its proposal to remove the claimsbased reporting option for this measure in 2015 PQRS. However, CMS is moving away from claims-based measures and therefore may reconsider the reporting options for this measure in future program years.

004 5/0 24 Communica tion and

Care Coordinatio n Osteoporosis: Communication with thePhysician Managing On-going Care PostFracture of Hip, Spine or Distal Radius for Men and Women Aged 50 Years and Older: Percentage of patients aged 50 years and older treated for a hip, spine or distal radial fracture with documentation of communication with the physician managing the patient’s on-going care that a fracture occurred and that the patient was or should be tested or treated for osteoporosis

Several commenters were concerned with CMS’ proposal to elimin ate the claims-based reporting option for various measures, noting that eligible professionals who may have reported on these measures do not have the resources to implement registry or EHR reporting and will no longer be able to participate in PQRS. Upon further review, CMS agrees that a significant number of providers that report th is measure will be negatively impacted by the removal of the claims-based option. Furthermore, this measure is a preventive care measure. Therefore, CMS is not finalizing its proposal to remove the claims-based reporting option for this measure in 2015 PQRS. However, CMS is moving away from claims-based measures and therefore may reconsider the reporting options for this measure in future program years. AMAPCPI NCQA X X

004 6/0 39 Effective Clinical

Care Screening or Therapy for Osteoporosis for Women Aged 65 Years and Older: Percentage of female patients aged 65 yearsand older who have a central dual-energy Xray absorptiometry (DXA) measurement ordered or performed at least once since age 60 or pharmacologic th erapy prescribed within 12 months

Several commenters were concerned with CMS’ proposal to elimin ate the claims-based reporting option for various measures, noting that eligible professionals who may have reported on these measures do not have the AMAPCPI NCQA X X XCMS-1612-FC 787NQF/PQRSCMSE-Measure ID National Quality Strategy Domain Measure Title and Description ¥Measure StewardClaimsCSVRegistryEHRGPRO (WebInterface)MeasuresGroupsOther QualityReportingPrograms

resources to implement registry or EHR reporting and will no longer be able to participate in PQRS. Upon further review, CMS identified this measure as a broadly applicable, preventive care measure. Therefore, CMS is not finalizing its proposal to remove the claims-based reporting option for this measure in 2015 PQRS. However, CMS is moving away from claims-based measures and therefore may reconsider the reporting options for this measure in future program years.

004 8/0 40 Effective Clinical

Care Osteoporosis: Management Following Fracture of Hip, Spine or Distal Radius for Men and Women Aged 50 Years and Older: Percentage of patients aged 50 years and older with fracture of the hip, spine, or distal radius who had a central dual-energy X-ray absorptiometry (DXA) measurement ordered or performed or pharmacologic therapy prescribed

Several commenters were concerned with CMS’ proposal to elimin ate the claims-based reporting option for various measures, noting that eligible professionals who may have reported on these measures do not have the resources to implement registry or EHR reporting and will no longer be able to participate in PQRS. Upon further review, CMS agrees that a significant number of providers that report th is measure will be negatively impacted by the removal of the claims-based option. Therefore, CMS is notfinalizing its proposal to remove the claimsbased reporting option for this measure in 2015 PQRS. However, CMS is moving away from claims-based measures and therefore may reconsider the reporting options for this measure in future program years. AMAPCPI NCQA X X

009 7/0 46 Communica tion and

Care Coordinatio n Medication Reconciliation: Percentage of patients aged 18 years and older discharged from any inpatient facility (for example, hospital, skilled nursing facility, or rehabilitation facility) and seen within 30 days following discharge in the office by the physician, prescribing practitioner, registered nurse, or clinical pha rmacist providing ongoing care who had a re conciliation of the discharge medications with the current medication list in the outpatient medical record documented. This measure is reported as two rates stratified by age group: Reporting Age Criteria 1: 18-64 years of age Reporting Age Criteria 2: 65 years and older AMAPCPI NCQA X XCMS-1612-FC 788NQF/PQRSCMSE-Measure ID National Quality Strategy Domain Measure Title and Description ¥Measure StewardClaimsCSVRegistryEHRGPRO (WebInterface)MeasuresGroupsOther QualityReportingPrograms

Several commenters were concerned with CMS’ proposal to elimin ate the claims-based reporting option for various measures, noting that eligible professionals who may have reported on these measures do not have the resources to implement registry or EHR reporting and will no longer be able to participate in PQRS. Upon further review, CMS agrees that a significant number of providers that report th is measure will be negatively impacted by the removal of the claims-based option. Therefore, CMS is notfinalizing its proposal to remove the claimsbased reporting option for this measure in 2015 PQRS. However, CMS is moving away from claims-based measures and therefore may reconsider the reporting options for this measure in future program years.

010 0/0 50 Person andCaregiverCentered Experience and Outcomes 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

Several commenters were concerned with CMS’ proposal to elimin ate the claims-based reporting option for various measures, noting that eligible professionals who may have reported on these measures do not have the resources to implement registry or EHR reporting and will no longer be able to participate in PQRS. Upon further review, CMS agrees that a significant number of providers that report th is measure will be negatively impacted by the removal of the claims-based option. Furthermore, CMS identified this measure as a preventive care measure. Therefore, CMS is not finalizing its proposal to remove the claims-based reporting option for this measure in 2015 PQRS. However, CMS is moving away from claims-based measures and therefore may reconsider the reporting options for this measure in future program years. NCQAAMAPCPI X X

009 0/0 54 Effective Clinical

Care Emergency Medicine: 12-Lead Electrocardiogram (ECG) Performed for Non-Traumatic Chest Pain: Percentage of patients aged 40 years and older with an emergency department discharge diagnosis of non-traumatic chest pain who had a 12- lead electrocardiogram (ECG) performed

Several commenters were concerned with CMS’ proposal to elimin ate the claims-based reporting option for various measures, noting AMAPCPI NCQA X XCMS-1612-FC 789NQF/PQRSCMSE-Measure ID National Quality Strategy Domain Measure Title and Description ¥Measure StewardClaimsCSVRegistryEHRGPRO (WebInterface)MeasuresGroupsOther QualityReportingPrograms

that eligible professionals who may have reported on these measures do not have the resources to implement registry or EHR reporting and will no longer be able to participate in PQRS. Upon further review, CMS agrees that a significant number of providers that report th is measure will be negatively impacted by the removal of the claims-based option. Therefore, CMS is notfinalizing its proposal to remove the claimsbased reporting option for this measure in 2015 PQRS. However, CMS is moving away from claims-based measures and therefore may reconsider the reporting options for this measure in future program years.

038 7/0 71 140 v3 Effective Clinical

Care 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

Several commenters were concerned with CMS’ proposal to elimin ate the claims-based reporting option for various measures, noting that eligible professionals who may have reported on these measures do not have the resources to implement registry or EHR reporting and will no longer be able to participate in PQRS. Upon further review, CMS agrees that a significant number of providers that report th is measure will be negatively impacted by the removal of the claims-based option. Therefore, CMS is notfinalizing its proposal to remove the claimsbased reporting option for this measure in 2015 PQRS. However, CMS is moving away from claims-based measures and therefore may reconsider the reporting options for this measure in future program years. AMAPCPI ASCO NCCN X X X X MU2

038 5/0 72 141 v3 Effective Clinical

Care Colon Cancer: Chemotherapy for AJCC Stage III Colon Cancer Patients: Percentage of patients aged 18 through 80 years with AJCC Stage III colon cancer who are referred for adjuvant chemotherapy, prescribed adjuvant chemotherapy, or have previously received adjuvant chemotherapy within the 12-month reporting period

Several commenters were concerned with CMS’ proposal to elimin ate the claims-based reporting option for various measures, noting that eligible professionals who may have reported on these measures do not have the AMAPCPI ASCO NCCN X X X X MU2CMS-1612-FC 790NQF/PQRSCMSE-Measure ID National Quality Strategy Domain Measure Title and Description ¥Measure StewardClaimsCSVRegistryEHRGPRO (WebInterface)MeasuresGroupsOther QualityReportingPrograms

resources to implement registry or EHR reporting and will no longer be able to participate in PQRS. Upon further review, CMS agrees that a significant number of providers that report th is measure will be negatively impacted by the removal of the claims-based option. Therefore, CMS is notfinalizing its proposal to remove the claimsbased reporting option for this measure in 2015 PQRS. However, CMS is moving away from claims-based measures and therefore may reconsider the reporting options for this measure in future program years.

N/ A/1 12 Effective Clinical

Care Breast Cancer Screening: Percentage of women 50 through 74 years of age who had a mammogram to screen for breast cancer within 27 months

Several commenters were concerned with CMS’ proposal to elimin ate the claims-based reporting option for various measures, noting that eligible professionals who may have reported on these measures do not have the resources to implement registry or EHR reporting and will no longer be able to participate in PQRS. Upon further review, CMS identified this as a broadly applicable, preventive care measure. Therefore, CMS is not finalizing its proposal to remove the claims-based reporting option for this measure in 2015 PQRS . However, CMS is moving away from claims-based measures and therefore may reconsider the reporting options for this measur e in future program years. NCQA X X X X X MU2

003

4 /11 3 130 v3 Effective Clinical

Care Colorectal Cancer Screening: Percentage of patients 50 through 75 years of age who had appropriate screening for colorectal cancer Several commenters were concerned with CMS’ proposal to elimin ate the claims-based reporting option for various measures, noting that eligible professionals who may have reported on these measures do not have the resources to implement registry or EHR reporting and will no longer be able to participate in PQRS. Upon further review, CMS identified this as a broadly applicable, preventive care measure. Therefore, CMS is not finalizing its proposal to remove the claims-based reporting option for this measure in 2015 PQRS . However, CMS is moving away from claims-based measures and therefore may reconsider the reporting options for this measur e in future program years. NCQA X X X X X MU2CMS-1612-FC 791NQF/PQRSCMSE-Measure ID National Quality Strategy Domain Measure Title and Description ¥Measure StewardClaimsCSVRegistryEHRGPRO (WebInterface)MeasuresGroupsOther QualityReportingPrograms

005

5 /11 7 131 v3 Effective Clinical

Care Diabetes: Eye Exam: Percentage of patients 18 through 75 years of age with a diagnosis of diabetes (type 1 and type 2) who had a retinal or dilated eye exam by an eye care professional in the measurement period or a negative retinal or dila ted eye exam (negative for retinopathy) in the year prior to the measurement period

Several commenters were concerned with CMS’ proposal to elimin ate the claims-based reporting option for various measures, noting that eligible professionals who may have reported on these measures do not have the resources to implement registry or EHR reporting and will no longer be able to participate in PQRS. Upon further review, CMS agrees that a significant number of providers that report th is measure will be negatively impacted by the removal of the claims-based option. In addition, many commenters supported the inclusion of the measure within the Shared Savings Program Diabetes Composite, but requested testing of the Composite measur e and submission to NQF. Some commenters did not support the addition of a process measure to the Shared Savings Program measure set and questioned the measure’s link to improving outcomes. Therefore, CMS is not finalizing its proposal to remove the claims-based reporting option for this measure in 2015 PQRS. However, CMS is moving away from claims-based measures and therefore may reconsider the reporting options for this measure in future program years. CMS will finalize adding the measure to the Shared Savings Program Diabetes Composite due to its clinical importance, alignment with PQRS, and stakeholder support. NCQA X X X X X ACO MU2

006

2 /11 9 134 v3 Effective Clinical

Care Diabetes: Medical Attention for Nephropathy: The percentage of patients 18-75 years of age with diabetes who had a nephropathy screening test or evidence of nephropathy during the measurement period

Several commenters were concerned with CMS’ proposal to elimin ate the claims-based reporting option for various measures, noting that eligible professionals who may have reported on these measures do not have the resources to implement registry or EHR reporting and will no longer be able to participate in PQRS. Upon further review, CMS agrees that a significant number of providers that report th is measure will be negatively impacted by the removal of the NCQA X X X X MU2CMS-1612-FC 792NQF/PQRSCMSE-Measure ID National Quality Strategy Domain Measure Title and Description ¥Measure StewardClaimsCSVRegistryEHRGPRO (WebInterface)MeasuresGroupsOther QualityReportingPrograms

claims-based option. Furthermore, CMS identified this measure as a preventive care measure. Therefore, CMS is not finalizing its proposal to remove the claims-based reporting option for this measure in 2015 PQRS. However, CMS is moving away from claims-based measures and therefore may reconsider the reporting options for this measure in future program years.

056

3 /14

1 Communica tion and

Care Coordinatio n Primary Open-Angle Glaucoma (POAG): Reduction of Intraoc ular Pressure (IOP) by 15% OR Documentation of a Plan of Care: Percentage of patients aged 18 yearsand older with a diagnosis of primary openangle glaucoma (POAG) whose glaucoma treatment has not failed (the most recent IOPwas reduced by at least 15% from the preintervention level) OR if the most recent IOP was not reduced by at least 15% from the pre-intervention level, a plan of care was documented within 12 months

Several commenters were concerned with CMS’ proposal to elimin ate the claims-based reporting option for various measures, noting that eligible professionals who may have reported on these measures do not have the resources to implement registry or EHR reporting and will no longer be able to participate in PQRS. Upon further review, CMS agrees that a significant number of providers that report th is measure will be negatively impacted by the removal of the claims-based option. Therefore, CMS is notfinalizing its proposal to remove the claimsbased reporting option for this measure in 2015 PQRS. However, CMS is moving away from claims-based measures and therefore may reconsider the reporting options for this measure in future program years. AAO X X

005

6 /16 3 123 v3 Effective Clinical

Care Diabetes: Foot Exam: Percentage of patients aged 18-75 years of age with diabetes who had a foot exam during the measurement period

Several commenters were concerned with CMS’ proposal to elimin ate the claims-based reporting option for various measures, noting that eligible professionals who may have reported on these measures do not have the resources to implement registry or EHR reporting and will no longer be able to participate in PQRS. Upon further review, CMS agrees that a significant number of providers that report th is measure will be negatively impacted by the removal of the claims-based option. Furthermore, CMS NCQA X X X X ACO MU2CMS-1612-FC 793NQF/PQRSCMSE-Measure ID National Quality Strategy Domain Measure Title and Description ¥Measure StewardClaimsCSVRegistryEHRGPRO (WebInterface)MeasuresGroupsOther QualityReportingPrograms

identified this as a preventive care measure. Therefore, CMS is not finalizing its proposal to remove the claims-based reporting option for this measure in 2015 PQRS. However, CMS is moving away from claims-based measures and therefore may reconsider the reporting options for this measure in future program years.

065

9 /18 5 Communica tion and

Care Coordinatio n Colonoscopy Interval for Patients with a History of Adenomatous Polyps – Avoidance of Inappropriate Use: Percentage of patients aged 18 years and older receiving a surveillance colonoscopy with a history of a prior adenomatous polyp(s) in previous colonoscopy findings, who had an interval of 3 or more years since their last colonoscopy

Several commenters were concerned with CMS’ proposal to elimin ate the claims-based reporting option for various measures, noting that eligible professionals who may have reported on these measures do not have the resources to implement registry or EHR reporting and will no longer be able to participate in PQRS. Upon further review, CMS agrees that a significant number of providers that report th is measure will be negatively impacted by the removal of the claims-based option. Therefore, CMS is notfinalizing its proposal to remove the claimsbased reporting option for this measure in 2015 PQRS. However, CMS is moving away from claims-based measures and therefore may reconsider the reporting options for this measure in future program years. AGA ASGE ACG X X

006 8/2 04 164 v3 Effective Clinical

Care Ischemic Vascular Di sease (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 coronary interventions (PCI) in the 12 months prior to the m easurement period, or who had an active di agnosis of ischemic vascular disease (IVD) during the measurement peri od and who had documentation of use of aspirin or another antithrombotic during the measurement period Commenters expressed concern with maintaining this measure in PQRS for EHR reporting only for the “sake of alignment with the EHR Incentive Program especially in the face of changing [clinical] evidence.” However, due to CMS’s desire to maintain NCQA X X X X MU2 Million HeartsCMS-1612-FC 794NQF/PQRSCMSE-Measure ID National Quality Strategy Domain Measure Title and Description ¥Measure StewardClaimsCSVRegistryEHRGPRO (WebInterface)MeasuresGroupsOther QualityReportingPrograms

alignment with the EHR Incentive Program, CMS will not make changes to EHR measures until the EHR Incentive Program is able to change this measure. commentsfrombut CMS is not finalizing its proposal to remove the claims, registry and GPRO reporting options for this measure. This measure will continue to be reportable through claims, registry, GPRO (including the Shared Savings Program), as well as EHR in PQRS 2015. However, CMS is moving away from claims-based measures and therefore may reconsider the reporting options for this measur e in future program years.

040

9 /20 5 Effective Clinical

Care HIV/AIDS: Sexually Transmitted Disease Screening for Chlamydia, Gonorrhea, and Syphilis: Percentage of patients aged 13 years and older with a diagnosis of HIV/AIDS for whom chlamydia, gonorrhea and syphilis screenings were performed at least once since the diagnosis of HIV infection

Several commenters were concerned with CMS’ proposal to elimin ate the claims-based reporting option for various measures, noting that eligible professionals who may have reported on these measures do not have the resources to implement registry or EHR reporting and will no longer be able to participate in PQRS. Upon further review, CMS agrees that a significant number of providers that report th is measure will be negatively impacted by the removal of the claims-based option. Therefore, CMS is notfinalizing its proposal to remove the claimsbased reporting option for this measure in 2015 PQRS. However, CMS is moving away from claims-based measures and therefore may reconsider the reporting options for this measure in future program years. NCQAAMAPCPI X X

065

1 /25 4 Effective Clinical

Care 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 bleeding who receive a trans-abdominal or trans-vaginal ultrasound to determine pregnancy location

Several commenters were concerned with CMS’ proposal to elimin ate the claims-based reporting option for various measures, noting that eligible professionals who may have reported on these measures do not have the ACEP X XCMS-1612-FC 795NQF/PQRSCMSE-Measure ID National Quality Strategy Domain Measure Title and Description ¥Measure StewardClaimsCSVRegistryEHRGPRO (WebInterface)MeasuresGroupsOther QualityReportingPrograms

resources to implement registry or EHR reporting and will no longer be able to participate in PQRS. Upon further review, CMS agrees that a significant number of providers that report th is measure will be negatively impacted by the removal of the claims-based option. Therefore, CMS is notfinalizing its proposal to remove the claimsbased reporting option for this measure in 2015 PQRS. However, CMS is moving away from claims-based measures and therefore may reconsider the reporting options for this measure in future program years.

065

2 /25 5 Effective Clinical

Care 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 offetal blood exposure who receive RhImmunoglobulin (Rhogam) in the emergency department (ED)

Several commenters were concerned with CMS’ proposal to elimin ate the claims-based reporting option for various measures, noting that eligible professionals who may have reported on these measures do not have the resources to implement registry or EHR reporting and will no longer be able to participate in PQRS. Upon further review, CMS agrees that a significant number of providers that report th is measure will be negatively impacted by the removal of the claims-based option. Therefore, CMS is notfinalizing its proposal to remove the claimsbased reporting option for this measure in 2015 PQRS. However, CMS is moving away from claims-based measures and therefore may reconsider the reporting options for this measure in future program years. ACEP X X

N/ A /26

8 Effective Clinical

Care 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

Several commenters were concerned with CMS’ proposal to elimin ate the claims-based reporting option for various measures, noting that eligible professionals who may have reported on these measures do not have the resources to implement registry or EHR reporting and will no longer be able to participate in PQRS. Upon further review, CMS agrees that a significant number of providers that report th is measure will be AAN X XCMS-1612-FC 796NQF/PQRSCMSE-Measure ID National Quality Strategy Domain Measure Title and Description ¥Measure StewardClaimsCSVRegistryEHRGPRO (WebInterface)MeasuresGroupsOther QualityReportingPrograms

negatively impacted by the removal of the claims-based option. Therefore, CMS is notfinalizing its proposal to remove the claimsbased reporting option for this measure in 2015 PQRS. However, CMS is moving away from claims-based measures and therefore may reconsider the reporting options for this measure in future program years.

N/ A/2 70 Effective Clinical

Care Inflammatory Bowel Disease (IBD): Preventive Care: Corticosteroid Sparing Therapy: Percentage of patients aged 18 years and older with a diagnosis of inflammatory bowel disease who have been managed by corticosteroids greater than or equal to 10 mg/day of prednisone equivalents for 60 or greater consecutive days or a single prescription equating to 600mg prednisone or greater for all fills that have been prescribed corticosteroid sparing therapy in the last reporting year Commenters requested this IBD measure and others noted in this table be reportable through registry in addition to the IBD Measure Group to better support providers reporting these measures. CMS agrees, and for this reason CMS is finalizing this measure with modificati ons as reportable in 2015 PQRS through registry and measure group. AGA X X

N/ A/2 71 Effective Clinical

Care Inflammatory Bowel Disease (IBD): Preventive Care: Corticosteroid Related Iatrogenic Injury – Bone Loss Assessment: Percentage of patients aged 18 years and older with an inflammatory bowel disease encounter who were prescribed prednisone equivalents greater than or equal to 10 mg/day for 60 or greater consecutive days or a single prescription equating to 600mg prednisone or greater for all fills and were documented for risk of bone loss once during the reporting year or the previous calendar year Commenters requested this IBD measure and others noted in this table be reportable through registry in addition to the IBD Measure Group to better support providers reporting these measures. CMS agrees, and for this reason CMS is finalizing this measure with modificati ons as reportable in 2015 PQRS through registry and measure group. AGA X X

N/ A/2 74 Effective Clinical

Care Inflammatory Bowel Disease (IBD): Testing for Latent Tuberculosis (TB) Before Initiating Anti-TNF (Tumor Necrosis Factor) Therapy: Percentage of AGA X XCMS-1612-FC 797NQF/PQRSCMSE-Measure ID National Quality Strategy Domain Measure Title and Description ¥Measure StewardClaimsCSVRegistryEHRGPRO (WebInterface)MeasuresGroupsOther QualityReportingPrograms

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 six months prior to receiv ing a first course of anti-TNF (tumor necrosis factor) therapy Commenters requested this IBD measure and others noted in this table be reportable through registry in addition to the IBD Measure Group to better support providers reporting these measures. CMS agrees, and for this reason CMS is finalizing this measure with modificati ons as reportable in 2015 PQRS through registry and measure group.

N/ A/2 75 Effective Clinical

Care 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 (IBD) who had Hepatitis B Virus (HBV) status assessed and results interpreted within one year prior to receiving a first course of anti-TNF (tumor necrosis factor) therapy Commenters requested this IBD measure and others noted in this table be reportable through registry in addition to the IBD Measure Group to better support providers reporting these measures. CMS agrees, and for this reason CMS is finalizing this measure with modificati ons as reportable in 2015 PQRS through registry and measure group. AGA X X

065

8 /32 0 Communica tion and

Care Coordinatio 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

Several commenters were concerned with CMS’ proposal to elimin ate the claims-based reporting option for various measures, noting that eligible professionals who may have reported on these measures do not have the resources to implement registry or EHR reporting and will no longer be able to participate in PQRS. Upon further review, CMS agrees that a significant number of providers that report th is measure will be negatively impacted by the removal of the claims-based option. Therefore, CMS is not AGA ASGE ACG X XCMS-1612-FC 798NQF/PQRSCMSE-Measure ID National Quality Strategy Domain Measure Title and Description ¥Measure StewardClaimsCSVRegistryEHRGPRO (WebInterface)MeasuresGroupsOther QualityReportingPrograms

finalizing its proposal to remove the claimsbased reporting option for this measure in 2015 PQRS. However, CMS is moving away from claims-based measures and therefore may reconsider the reporting options for this measure in future program years.

152 5 /32 6 Effective Clinical

Care Atrial Fibrillation and Atrial Flutter: Chronic Anticoagulation Therapy: Percentage of patients aged 18 and older with a diagnosis of nonvalvul ar atrial fibrillation (AF) or atrial flutter whose assessment of the specified thromboembolic risk factors indicate one or more high-risk factors or more than one modera te risk factor, as determined by CHADS 2 risk stratification, who were prescribed warfarin OR another oral anticoagulant drug that is FDA approved for the prevention of thromboembolism

Several commenters were concerned with CMS’ proposal to elimin ate the claims-based reporting option for various measures, noting that eligible professionals who may have reported on these measures do not have the resources to implement registry or EHR reporting and will no longer be able to participate in PQRS. Upon further review, CMS agrees that a significant number of providers that report th is measure will be negatively impacted by the removal of the claims-based option. Therefore, CMS is notfinalizing its proposal to remove the claimsbased reporting option for this measure in 2015 PQRS. However, CMS is moving away from claims-based measures and therefore may reconsider the reporting options for this measure in future program years. AMAPCPI ACCF AHA X X

¥ Measure details including titles , descriptions and measure owne r information may vary during a particular program year. This is due to the timing of measure specification preparation and the m easure versions used by the va rious reporting options/methods. Please refer to the measure spec ifications that apply for each of the reporting options/m ethods for specific measure details.

d. PQRS Measures Groups Section 414.90(b) defines a measures group as a subset of four or more PQRS measures that have a particular clinical condition or focus in common. The denominator definition and coding of the measures group identifies the condition or focus that is shared across the measur es within a particular

measures group.CMS-1612-FC 799

In the CY 2014 PFS proposed rule, we proposed (78 FR 43448) to increase the number of measures that may be included in a measures group fr om a minimum of 4 measures to a minimum of 6. We proposed increasing the minimum number of measures that may be contained in a measures group in accordance with increasing the number of individual meas ures to be reported via claims and registry. However, we did not finalize this proposal, stating that, although we still plan to increase the minimum number of measures in a measures group in the future, we would work with the measure developers and owners of these measures groups appropriately to add measures to measures groups that only contain four measures within the measures group (78 FR 74730). For CY 2015, we again we proposed to modify §414.90(b) to define a measures group as a subset of si x or more PQRS measures that have a particular clinical condition or focus in common (79 FR 40457) . We solicited and received the following public comment on this proposal: Comment: Several commenters opposed this pr oposal. Commenters noted that CMS did not work with the measure group develo pers and owners to create the pr oposed measures groups that consist

of at least 6 measures and were concerned that th e additional measures in the proposed measures groups were arbitrarily added and not relevant to the measures already contained in the measures group. Response: While we understand the commenters’ concerns that the additional measures may not be relevant to the measure group topic or condition, we note that we have performed clinical analyses to

ensure that the added measures relate to the measure group topics and conditions. The addition of measures within the measures groups was not arbitrary. While some of the measures did not address the specific topic or condition depicted, we added measu res within the measures groups that we believed were clinically relevant t o report, as we believe these meas ures address topics and clinical conditions that are accepted in th e clinical community as critical to monitor. For example, in most instances, we added measures from the cross-cutting measures set such as Tobacco Screening and Cessation and Medication Reconcil iation. With respect to the concern that measures developers and measure owners were not consulted when deve loping our proposal to add measures to the measures groups, we will con tinue to work with the measure developers andCMS-1612-FC 800

owners to address any concerns they may have with the fina l measures groups and address changes when needed through future rulemaking. Based on the reasons stated here and in the proposed rule, we are finalizing our proposal to modify §414.90(b) to define a measures group as a subset of six or more PQRS measures that ha ve a particular clinical condition or focus in

common. In addition, we proposed to add two new meas ures groups that will be available for reporting in the PQRS beginning in 2015: the Sinusitis and Acute O titis Externa (AOE) measures groups (79 FR 40457). Furthermore, we proposed to remove the following measures groups (79 FR 40457):

● Perioperative care measures group;

● Back pain measures group;

● Cardiovascular prevention measures group;

● Ischemic Vascular Dis ease (IVD) measures group;

● Sleep Apnea measures group; and

● Chronic obstructive pulmonary disease (COPD) measures group. We received the following comments on our prop osals related to our proposals related to either the proposed addition or removal of the following measures groups: Comments on the proposed removal of the Pe rioperative Care Measures Group: Several commenters requested that CMS retain the Peri operative Care Measures Group and the related individual measures noting th e following: “there is a bias in measuring that improves performance; (2) there are few m easures applicable to surgeons it will be much harder to participate in PQRS without the perioperative measures.” Response: While there has been evidence to suggest there may be a bias in measuring that improves performance, there is an equal amount of evidence to the contrary that suggest thisCMS-1612-FC 801

bias is not impactful. Additionally, we believe that there are a number of broadly applicable measures that these specialty surgeons can repo rt. For these reasons, we are finalizing our proposal to remove the Perioperative Care Measure Group from reporting in 2015 PQRS. Comments on the proposed removal of th e Back Pain Measures Group: Several

commenters were concerned with the proposal to remove the Back Pain measures group, noting it would negatively impact physician anesthesiolo gists’, pain medicine physicians’ and physical therapists’ ability to report. Other commenters supported the rem oval of some of the Back Pain measure group measures such as “Back Pain: Init ial Visit” and “Back Pain: Physical Exam.” Response: The measures in this measure gr oup reflect clinical con cepts that do not add clinical value to PQRS. Specifically, the measur es in this group are en tirely clinical process measures that do not meaningfully contribute to improved patient outcomes, and CMS believes that removal of this measure group will not nega tively impact physician anesthesiologists’, pain medicine physicians’, and physical therapists’ ab ility to report. For these reasons, we are finalizing our proposal to remove the Back Pa in Measure Group from reporting in 2015 PQRS. Comments on the proposed removal of the Cardiovascular Prevention Measures Group: We proposed to remove the cardiovascular prevention measures group because a number of

individual measures contained in this measures group are proposed to be removed from all PQRS program reporting options with the exception of EHR reporting. No comments were received about the removal of this measure group. For thes e reasons, we are fina lizing our proposal to

remove the Cardiovascular Prevention Measure Group from reporting in 2015 PQRS. Comments on the proposed removal of the Is chemic Vascular Disease Measures Group: We proposed to remove the cardiovascular prevention measures group because a number of

individual measures contained in this measures group are proposed to be removed from all PQRS program reporting options with the exception of EHR reporting. No comments were receivedCMS-1612-FC 802

about the removal of this measure group. For thes e reasons, we are fina lizing our proposal to

remove the Ischemic Vascular Disease Measure Group from reporting in 2015 PQRS. Comments on the proposed addition of the Acute Otitis Externa (AOE) Measures Group: One commenter supported the add ition of this measure group. Response: We did not receive any dissenti ng comments. For these reasons, we are finalizing our proposal to include the AOE measure group for reporting in 2015 PQRS. Comments on the proposed removal of the Chronic Obstructive Pulmonary Disorder (COPD) Measures Group: We initially proposed to remove this measure group contingent on the measure steward not being able to maintain cert ain measures contained in this measures group (79 FR 40457). A new steward has been identified for the measures at risk, and for this reason we are not finalizing our proposal to remove this measures group in 2015. Comments on the proposed removal of the Sleep Apnea Measures Group: We initially proposed to remove this measures group continge nt on the measure steward not being able to

maintain certain measures contained in this m easures group. A new stewar d has been identified for the measures at risk, and for this reason we are not finalizing our proposal to remove this measures group in 2015. Comments on the proposed Rheumatoid Arthritis Measures Group: Commenters disagreed with CMS's proposal to add the Preventive Care and Screening: Influenza Immunization (PQRS #110) and Preventive Care and Screening: Tobacco Use: Screening and Cessation Intervention (PQRS #226) measures to the Rheumatoid Arthritis Measures Group for

CY 2015. Commenters did not believe these measur es provide substantial value to the specific

clinical focus of this meas ures group. Instead, commenters recommend the addition of crosscutting measure Preventive Care and Screenin g: Body Mass Index (BMI) Screening and Follow (PQRS #128) and Pain Assessment and Follow-up (PQRS #131) to achie ve the goal of sixCMS-1612-FC 803

measures while retaining clinical relevance. CMS agrees wi th commenters’ suggestions and thus is not finalizing the proposal to add PQRS #110 and #226 to this measure group, but rather will add PQRS #128 and #131 to better support the cl inical purpose of this measure group while meeting the six measure minimum requirement. Tables 57 through 79 specify our final measures groups in light of the reasons stated in the proposed rule and the comments received. Please note that some me asures groups were not addressed above. With respect to the measures groups that were not addressed above, we did not receive any comments on these proposed measur es groups and are therefore finalizing the respective measures groups as proposed.CMS-1612-FC 804

TABLE 57: Asthma Measures Group for 2015 and Beyond NQF/ PQRS Measure Title and Description Measure Developer

0047/053 Asthma: Pharmacologic Ther apy for Persistent Asthma - Ambulatory Care Setting: Percentage of patients aged 5 through 64 years with a diagnosis of persistent asthma who were prescribed long-term control medication AMA-PCPI/NCQA

0041/110 Preventive Care and Screening: Influenza Immunization: Percentage of patients aged 6 months and older seen for a visit between Oc tober 1 and March 31 who received an influenza immunization OR who reported previous receipt of an influenza immunization AMA-PCPI

0419/130 Documentation of Current Medications in the Medical Record: Percentage of visits for patients aged 18 years and older for which the eligible professional attests to documenting a list of current medications using all immedi ate resources available on the date of the encounter. This list must incl ude ALL known prescriptions, over- the-counters, herbals, and vitamin / mineral / dietary (nutritional) s upplements AND must contain the medications’ name, dosage, frequency and route of administration CMS/QIP

0028/226 Preventive Care and Screening: Tobacco Use: Screening and Cessation Intervention: Percentage of patients aged 18 years and olde r who were screened for tobacco use one or more times within 24 months AND who recei ved cessation counseling intervention if identified as a tobacco user AMA-PCPI

N/A/402 Tobacco Use and Help with Quitting Among Adolescents: Percentage of adolescents 13 to 20 years of age with a primary care visit during the measurement period for whom tobacco use status was documented and received help quitting if identified as a tobacco user. NCQA / NCIQM

0421/128 Preventive Care and Screening: Body Mass Index (BMI) Screening and Follow-Up Plan: Percentage of patients aged 18 years and older with a BMI documented during the current encounter or during the previous si x months AND with a BMI outisde of normal parameters, a follow-up plan is documented duri ng the encounter or during the previous six months of the encounter Normal Parameters: Age 65 years and older BMI ≥ 23 and < 30 kg/m 2 ; Age 18 – 64 years BMI ≥ 18.5 and < 25 kg/m 2 CMS/QIP

TABLE 58: Acute Otitis Externa (A OE) Measures Group for 2015 and Beyond NQF/ PQRS Measure Title and Description Measure Developer 0653/091 Acute Otitis Externa (A OE): Topical Therapy: Percentage of patients aged 2 years and older with a diagnosis of AOE who we re prescribed topical preparations AMA-PCPI

0654/093 Acute Otitis Externa (AOE): Systemic Antimicrobial Therapy – Avoidance of Inappropriate Use: Percentage of patients aged 2 year s and older with a diagnosis of AOE who were not prescribed systemic antimicrobial therapy AMA-PCPI

0419/130 Documentation of Current Medications in the Medical Record: Percentage of visits for patients aged 18 years and older for which the eligible professional attests to documenting a list of current medications using all immedi ate resources available on the date of the encounter. This list must include ALL known pr escriptions, over-the-counters, herbals, and vitamin / mineral / dietary (nutritional) s upplements AND must cont ain the medications’ name, dosage, frequency and route of administration CMS/QIP

0420/131 Pain Assessment and Follow-Up: Percentage of visits for patients aged 18 years and older with documentation of a pain assessment usi ng a standardized tool (s) on each visit AND documentation of a follow-up plan when pain is present CMS/QIP

0101/154 Falls: Risk Assessment: Percentage of patients aged 65 years and older with a history of falls who had a risk assessment for falls completed within 12 months AMA-PCPI

0101/155 Falls: Plan of Care : Percentage of patients aged 65 years and older with a history of falls who had a plan of care for falls documented within 12 months AMA-PCPI

0028/226 Preventive Care and Screening: Tobacco Use: Screening and Cessation Intervention: Percentage of patients 18 years and older who were screened for tobacco use one or more times within 24 months AND who received cessa tion counseling intervention if identified as a tobacco user AMA-PCPI

N/A/317 Preventive Care and Screening: Screening for High Blood Pressure and Follow-Up Documented: Percentage of patients aged 18 y ears and older seen during the reporting period who were screened for high blood pressure AND a recommended follow-up plan is documented based on the current blood pressure (BP) reading as indicated CMS/QIPCMS-1612-FC 805

TABLE 59: Cataracts Measures Group for 2015 and Beyond NQF/ PQRS Measure Title and Description Measure Developer

0419/130 Documentation of Current Medications in the Medical Record: Percentage of visits for patients aged 18 years and older for which the eligible professional attests to documenting a list of current medications using all immedi ate resources available on the date of the encounter. This list must include ALL known pr escriptions, over-the-counters, herbals, and vitamin/mineral/dietary (nutr itional) supplements AND must c ontain the medications’ name, dosage, frequency and route of administration CMS/QIP

0565/191 Cataracts: 20/40 or Better Visual Acuity within 90 Days Following Cataract Surgery: Percentage of patients aged 18 years and older with a diagnosis of uncomplicated cataract who had cataract surgery and no significant oc ular conditions impacting the visual outcome of surgery and had best-corrected visual acuity of 20/40 or better (dis tance or near) achieved within 90 days following the cataract surgery AMA-PCPI/NCQA

0564/192 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 catar act who had cataract surgery and had any of a specified list of surgical procedures in the 30 days followi ng cataract surgery which would indicate the occurrence of any of the following major complications: retained nuclear fragments, endophthalmitis, dislocated or wrong power IOL, retinal detachment, or wound dehiscence AMA-PCPI/NCQA

0028/226 Preventive Care and Screening: Tobacco Use: Screening and Cessation Intervention: Percentage of patients 18 years and older who were screened for tobacco use one or more times within 24 months AND who received cessa tion counseling intervention if identified as a tobacco user AMA-PCPI

N/A/303 Cataracts: Improvement in Patient’s Visu al Function within 90 Days Following Cataract Surgery: Percentage of patients aged 18 years and older in sample who had cataract surgery and had improvement in visual function achieved within 90 days following the cataract surgery, based on completing a pr e-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 Provide rs and Systems Surgical Care Survey AAO

N/A/388 Cataract Surgery with Intra-Operative Complications (Unplanned Rupture of Posterior Capsule Requiring Unplanned Vsitrectomy): Rupture of the posterior capsule during anterior segment surgery requiring vsitrectomy AAEECE/ACHS

N/A/389 Cataract Surgery: Difference Between Planned and Final Refraction: Percentage of patients who achieve planne d refraction within +-1,0 D AAEECE/ACHSCMS-1612-FC 806

TABLE 60: Chronic Kidney Disease (C KD) Measures Group for 2015 and Beyond NQF/ PQRS Measure Title and Description Measure Developer

0326/047 Care Plan: Percentage of patients aged 65 years a nd older who have an advance care plan or surrogate decision maker documented in the me dical record or documentation in the medical record that an advance care plan was discussed but the patient did not wish or was not able to name a surrogate decisi on maker or provide an advance care plan AMAPCPI/NCQA

0041/110 Preventive Care and Screening: Influenza Immunization: Percentage of patients aged 6 months and older seen for a vi sit between October 1 and March 31 who received an influenza immunization OR who reported previous receipt of an influenza immunization AMA-PCPI

1668/121 Adult Kidney Disease: Laboratory Testing (Lipid Profile): Percentage of patients aged 18 years and older with a diagnosis of chronic kidney disease (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 AMA-PCPI

N/A/122 Adult Kidney Disease: Blood Pressure Management: Percentage of patient visits for those patients aged 18 years and older with a diagnosis of chronic kidney disease (CKD) (stage 3, 4, or 5, not receiving Renal Replacement Therapy [RRT ]) and proteinuria with a blood pressure < 140/90 mmHg OR ≥ 140/90 mmHg with a documented plan of care AMA-PCPI

0419/130 Documentation of Current Medications in the Medical Record: Percentage of visits for patients aged 18 years and older for which the eligible professional attests to documenting a list of current medications using all imme diate resources available on the date of the encounter. This list must include ALL known prescriptions, over-the-c ounters, herbals, and vitamin/mineral/dietary (nutritional) supplements AND must contain the medications’ name, dosage, frequency and route of administration CMS/QIP

0028/226 Preventive Care and Screening: Tobacco Use: Screening and Cessation Intervention: Percentage of patients 18 years and older who were screened for tobacco use one or more times within 24 months AND who receiv ed cessation counseling interventio n if identified as a tobacco user AMA-PCPICMS-1612-FC 807

TABLE 61: Chronic Obstructive Pulmonary Disorder (COPD) Measures Group for 2015 and Beyond (Please note that CMS initially proposed to remove this measure group contingent on the measure steward not being able to maintain certain measures contained in this measures group. A new steward has been identified for the measures at risk and for this reason CMS is not finalizing its proposal to remove this measures group in 2015.)

NQF/ PQRS Measure Title and Description Measure Developer

0326/047 Care Plan: Percentage of patients aged 65 years a nd older who have an advance care plan or surrogate decision maker documented in the me dical record or documentation in the medical record that an advance care plan was discussed but the patient did not wish or was not able to name a surrogate decisi on maker or provide an advance care plan AMAPCPI/NCQA

0091/051 Chronic Obstructive Pulmonary Dise ase (COPD): Spirometry Evaluation: Percentage of patients aged 18 years and older with a diagnosis of COPD who had spirometry evaluation results documented AMA-PCPI

0102/052 Chronic Obstructive Pulmonary Disease (COPD): Inhaled Bronchodilator Therapy: Percentage of patients aged 18 years and older with a diagnosis of COPD and who have an FEV1/FVC less than 60% and have symptoms w ho were prescribed an inhaled bronchodilator AMA-PCPI

0041/110 Preventive Care and Screening: Influenza Immunization: Percentage of patients aged 6 months and older seen for a vi sit between October 1 and March 31 who received an influenza immunization OR who reported previous receipt of an influenza immunization AMA-PCPI

0043/111 Pneumonia Vaccination Status for Older Adults: Percentage of patients 65 years of age and older who have ever received a pneumococcal vaccine NCQA

0419/130 Documentation of Current Medications in the Medical Record: Percentage of visits for patients aged 18 years and older for which the eligible professional attests to documenting a list of current medications using all imme diate resources available on the date of the encounter. This list must include ALL known prescriptions, over-the-c ounters, herbals, and vitamin/mineral/dietary (nutritional) supplements AND must contain the medications’ name, dosage, frequency and route of administration CMS/QIP

0028/226 Preventive Care and Screening: Tobacco Use: Screening and Cessation Intervention: Percentage of patients 18 years and older who were screened for tobacco use one or more times within 24 months AND who receiv ed cessation counseling interventio n if identified as a tobacco user AMA-PCPICMS-1612-FC 808

TABLE 62: Coronary Artery Bypass Graft (CABG) Measur es Group for 2015 and Beyond NQF/ PQRS Measure Title and Description Measure Developer

0134/043 Coronary Artery Bypass Graft (CABG): Use of Internal Mammary Artery (IMA) in Patients with Isolated CABG Surgery: Percentage of patients aged 18 years and older undergoing isolated CABG surgery who received an IMA graft STS

0236/044 Coronary Artery Bypass Graft (CABG): Preoperative Beta-Blocker in Patients with Isolated CABG Surgery: Percentage of isolated Coronary Artery Bypass Graft (CABG) surgeries for patients aged 18 years and older who received a beta-blocker within 24 hours prior to surgical incision CMS/QIP

0129/164 Coronary Artery Bypass Graft (CABG): Prolonged Intubation: Percentage of patients aged 18 years and older undergoing isolated CABG surgery who require postoperative intubation > 24 hours STS

0130/165 Coronary Artery Bypass Graft (CABG ): Deep Sternal Wound Infection Rate: Percentage of patients aged 18 years and ol der undergoing isolated CABG surgery who, within 30 days postoperatively, develop de ep 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 (that is, 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 postoperative 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 hospita lization for mediastina l bleeding with or without tamponade, graft occl usion, valve dysfunction, or other cardiac reason. Please note that CMS had proposed to remove this measure from the pr ogram and thus this measure group as a result in th e NPRM. However, as noted above in Table 55, CMS is not finalizing its proposal to rem ove this measure, and as such, the measure is not being removed from this measure group either. STSCMS-1612-FC 809

TABLE 63: Coronary Artery Disease (CAD) Measures Group for 2015 and Beyond NQF/ PQRS Measure Title and Description Measure Developer

0067/006 Coronary Artery Disease (CAD): Antiplatelet Therapy: Percentage of patients aged 18 years and older with a diagnosis of coronary ar tery disease seen within a 12 month period who were prescribed aspirin or clopidogrel AMAPCPI/ACCF/AHA

0070/007 Coronary Artery Disease (CAD): Beta-Blocker Therapy – Prior Myocardial Infarction (MI) or Left Ventricular Systolic Dysfunction (LVEF < 40%: Percentage of patients aged 18 years and older with a diagnosis of coronary artery disease seen within a 12 month period who also have prior MI OR a current or prior LVEF < 40% who were prescribed beta-blocker therapy AMA-PCPI

0421/128 Preventive Care and Screening: Body Mass Index (BMI) Screening and Follow-Up Plan: Percentage of patients aged 18 years an d older with a BMI documented during the current encounter or during the previous si x months AND with a BMI outside of normal parameters, a follow-up plan is documented du ring the encounter or during the previous six months of the encounter Normal Parameters: Age 65 years and older BMI ≥ 23 and < 30 kg/m 2 ; Age 18 – 64 years BMI ≥ 18.5 and < 25 kg/m 2 CMS/QIP

0419/130 Documentation of Current Medications in the Medical Record: Percentage of visits for patients aged 18 years and older for which the eligible professional attests to documenting a list of current medications using all immedi ate resources available on the date of the encounter. This list must include ALL known pr escriptions, over-the-counters, herbals, and vitamin/mineral/dietary (nutr itional) supplements AND must c ontain the medications’ name, dosage, frequency and route of administration CMS/QIP

0028/226 Preventive Care and Screening: Tobacco Use: Screening and Cessation Intervention: Percentage of patients 18 years and older who were screened for tobacco use one or more times within 24 months AND who received cessa tion counseling intervention if identified as a tobacco user AMA-PCPI

N/A/242 Coronary Artery Disease (CAD): Symptom Management: Percentage of patients aged 18 years and older with a diagnosis of coronary ar tery disease seen within a 12 month period with results of an evaluation of level of activity and an assessment of whether anginal symptoms are present or absent with appropria te management of anginal symptoms within a 12 month period AMAPCPI/ACCF/AHACMS-1612-FC 810

TABLE 64: Dementia Measures Group for 2015 and Beyond NQF/ PQRS Measure Title and Description Measure Developer

0326/047 Care Plan: Percentage of patients aged 65 years a nd older who have an advance care plan or surrogate decision maker documented in the me dical record or documentation in the medical record that an advance care plan was discussed but the patient did not wish or was not able to name a surrogate decisi on maker or provide an advance care plan AMA-PCPI/NCQA

N/A/280 Dementia: Staging of Dementia: Percentage of patients, regard less 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 assessmen t of functional status is performed and the results reviewed at least once within a 12 month period AMA-PCPI

N/A/283 Dementia: Neuropsychiatric Symptom Assessment: Percentage of patients, regardless of age, with a diagnosis of dementia and fo r whom an assessment of neuropsychiatric symptoms is performed and results review ed 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 deme ntia who have one or more neuropsychiatric symptoms who received or were recommended to receive an intervention for neuropsychiatric symptoms within a 12 month period AMA-PCPI

N/A/285 Dementia: Screening for Depressive Symptoms: Percentage of patients, regardless of age, with a diagnosis of dementia who were screen ed 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 their car egiver(s) who were couns eled or referred for counseling regarding safety conc erns within a 12 month period AMA-PCPI

N/A/287 Dementia: Counseling Regar ding Risks of Driving: Percentage of patients, regardless of age, with a diagnosis of dementia or their caregiver(s) who were c ounseled regarding the risks of driving and the alternatives to driv ing at least once with in a 12 month period AMA-PCPI

N/A/288 Dementia: Caregiver Education and Support: Percentage of patients, regardless of age, with a diagnosis of dementia whose caregive r(s) were provided with education on dementia disease management and health behavior changes AND referre d to additional sources for support within a 12 month period AMA-PCPI

TABLE 65: Diabetes Measures Group for 2015 and Beyond NQF/ PQRS Measure Title and Description Measure Developer 0059/001 Diabetes: Hemoglobin A1c Poor Control : Percentage of patients 18-75 years of age with diabetes who had hemoglobin A1c > 9. 0% during the measurement period NCQA

0041/110 Preventive Care and Screening: Influenza Immunization: Percentage of patients aged 6 months and older seen for a vi sit between October 1 and March 31 who received an influenza immunization OR who reported previous receipt of an influenza immunization AMA-PCPI

0055/117 Diabetes: Eye Exam : Percentage of patients 18 through 75 years of age with a diagnosis of diabetes (type 1 and type 2) who had a retinal or dilated eye exam in the measurement period or a negative retinal or dilated eye exam (negative for retinopathy) in the year prior to the measurement period NCQA

0062/119 Diabetes: Medical Attention for Neuropathy: The percentage of patients 18-75 years of age with diabetes who had a nephropathy scr eening test or evidence of nephropathy during the measurement period NCQA

0056/163 Diabetes: Foot Exam: Percentage of patients aged 18-75 years of age with diabetes who had a foot exam during th e measurement period NCQA

0028/226 Preventive Care and Screening: Tobacco Use: Screening and Cessation Intervention: Percentage of patients 18 years and older who were screened for tobacco use one or more times within 24 months AND who received cessa tion counseling intervention if identified as a tobacco user AMA-PCPICMS-1612-FC 811

TABLE 66: General Surgery Me asures Group for 2015 and Beyond NQF/ PQRS Measure Title and Description Measure Developer

0419/130 Documentation of Current Medications in the Medical Record: Percentage of visits for patients aged 18 years and older for which the eligible professional attests to documenting a list of current medications using all immedi ate resources available on the date of the encounter. This list must include ALL known pr escriptions, over-the-counters, herbals, and vitamin/mineral/dietary (nutr itional) supplements AND must c ontain the medications’ name, dosage, frequency and route of administration CMS/QIP

0028/226 Preventive Care and Screening: Tobacco Use: Screening and Cessation Intervention: Percentage of patients 18 years and older who were screened for tobacco use one or more times within 24 months AND who received cessa tion counseling intervention if identified as a tobacco user AMA-PCPI

N/A/354 Anastomotic Leak Intervention: Percentage of patients aged 18 years and older who required an anastomotic leak intervention following gastric bypass or colectomy surgery ACS

N/A/355 Unplanned Reoperation within th e 30 Day Postop erative Period: Percentage of patients aged 18 years and older who had any unplanne d reoperation within the 30 day postoperative period ACS

N/A/356 Unplanned Hospital Readmi ssion within 30 Days of Principal Procedure: Percentage of patients aged 18 years and older who had an unplanned hospital readmission within 30 days of principal procedure ACS

N/A/357 Surgical Site Infection (SSI): Percentage of patients aged 18 years and older who had a surgical site infection (SSI) ACS

N/A/358 Patient-Centered Surgical Risk Assessment and Communication: Percentage of patients who underwent a non-emergency surgery who had their personalized risks of postoperative complications assessed by their surgical team prior to surgery using a clinical data-based, patient-specific risk calculator and who recei ved personal discussion of those risks with the surgeon ACS

TABLE 67: Heart Failure (HF) Measures Group for 2015 and Beyond NQF/ PQRS Measure Title and Description Measure Developer

0081/005 Heart Failure (HF): 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 wi th a diagnosis of heart failure (HF) with a current or prior left ventricu lar ejection fraction (LVEF) < 40% who were prescribed ACE inhibitor or ARB therapy either within a 12 month period when seen in the outpatient setting OR at each hospital discharge AMAPCPI/ACCF/AHA

0083/008 Heart Failure (HF): Beta-Blocker Therapy for Left Ventricular Systolic Dysfunction (LVSD): Percentage of patients aged 18 years an d older with a diagnosis of heart failure (HF) with a current or prior left ventricu lar 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/AHA

0326/047 Care Plan: Percentage of patients aged 65 years and older who have an advance care plan or surrogate decision maker documented in the medical record or documentation in the medical record that an advance care plan was discussed but the patient did not wish or was not able to name a surroga te decision maker or provide an advance care plan AMA-PCPI/NCQA

0041/110 Preventive Care and Screening: Influenza Immunization: Percentage of patients aged 6 months and older seen for a visit between October 1 and March 31 who received an influenza immunization OR who reported previo us receipt of an influenza immunization. AMA-PCPI

0419/130 Documentation of Current Medications in the Medical Record: Percentage of visits for patients aged 18 years and older for which the eligible professional attests to documenting a list of current medications using all immedi ate resources available on the date of the encounter. This list must include ALL known pr escriptions, over-the-counters, herbals, and vitamin / mineral / dietary (nutritional) s upplements AND must cont ain the medications’ name, dosage, frequency and route of administration CMS/QIP

0028/226 Preventive Care and Screening: Tobacco Use: Screening and Cessation Intervention: Percentage of patients 18 years and older who were screened for tobacco use one or more times within 24 months AND who received ce ssation counseling intervention if identified as a tobacco user AMA-PCPICMS-1612-FC 812

TABLE 68: Hepatitis C Measures Group for 2015 and Beyond NQF/ PQRS Measure Title and Description Measure Developer

0395/084 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 started antiviral treatment within the 12 month reporting period for whom quantitative hepatitis C virus (HCV) RNA testing was performed within 12 months prior to initiation of antiviral treatment AMA-PCPI

0396/085 Hepatitis C: HCV Genotype Testing Prior to Treatment: Percentage of patients aged 18 years and older with a diagnosis of chronic hepa titis C who started anti viral treatment within the 12 month reporting period for whom hepatitis C virus (HCV) genotype testing was performed within 12 months prior to initiation of antiviral treatment AMA-PCPI

0398/087 Hepatitis C: Hepatitis C Vi rus (HCV) Ribonucleic Acid (RNA) Testing Between 4-12 Weeks After Initiation of Treatment: Percentage of patients aged 18 years and older with a diagnosis of chronic hepatitis C who ar e receiving antiviral treatment for whom quantitative hepatitis C virus (HCV) RNA testing was performed between 4-12 weeks after the initiation of antiviral treatment AMA-PCPI

0419/130 Documentation of Current Medications in the Medical Record: Percentage of visits for patients aged 18 years and older for which the eligible professional attests to documenting a list of current medications using all immedi ate resources available on the date of the encounter. This list must include ALL known pr escriptions, over-the-counters, herbals, and vitamin/mineral/dietary (nutritional) suppl ements AND must cont ain the medications’ name, dosage, frequency and route of administration CMS/QIP

0399/183 Hepatitis C: Hepatitis A Vaccination in Patients with Hepatitis C Virus (HCV): Percentage of patients aged 18 years and older with a diagnosis of chronic hepatitis C who have received at least one injection of hepatitis A vaccine, or who have documented immunity to hepatitis A AMA-PCPI

0028/226 Preventive Care and Screening: Tobacco Use: Screening and Cessation Intervention: Percentage of patients 18 years and older who were screened for tobacco use one or more times within 24 months AND who received cessa tion counseling intervention if identified as a tobacco user AMA-PCPI

N/A/401 Screening for Hepatocellular Carcinoma (HCC) in patients with Hepatitis C Cirrhosis: Percentage of patients aged 18 years and older with a diagnosis of chronic hepatitis C cirrhosis who underwent imaging with either ultrasound, contrast enhanced CT or MRI for hepatocellular carcinoma (HCC) at least onc e within the 12 month reporting period AGA/AASLD/AMAPCPI

N/A/390 Discussion and Shared Decision Ma king Surrounding Treatment Options: Percentage of patients aged 18 years and older with a diag nosis of hepatitis C with whom a physician or other qualified healthcare professional reviewed the range of treatment options appropriate to their genotype and demonstrated a shared decision making approach with the patient. To meet the measure, there must be documenta tion in the patient record of a discussion between the physician or other qualified health care professional and the patient that includes all of the following: treatment choices appropria te to genotype, risks and benefits, evidence of effectiveness, and patient preferences toward treatment AGA/AASLD/AMAPCPICMS-1612-FC 813

TABLE 69: HIV/AIDS Measures Group for 2015 and Beyond NQF/ PQRS Measure Title and Description Measure Developer

0326/047 Care Plan: Percentage of patients aged 65 years a nd older who have an advance care plan or surrogate decision maker documented in the me dical record or documentation in the medical record that an advance care plan was discussed but the patient did not wish or was not able to name a surrogate decisi on maker or provide an advance care plan AMA-PCPI/NCQA

0418/134 Preventive Care and Screening: Screening for Clinical Depression and Follow-Up Plan: Percentage of patients aged 12 years and older sc reened for clinical depression on the date of the encounter using an age appropriate stan dardized depression screening tool AND if positive, a follow-up plan is documented on the date of the positive screen CMS/QIP

0405/160 HIV/AIDS: Pneumocystis Jiroveci Pneumonia (PCP) Prophylaxis: Percentage of patients aged 6 weeks and older with a diagnosis of HIV/AIDS who were prescribed Pneumocystis Jiroveci Pneumonia (PCP) prophylaxis NCQA

0409/205 HIV/AIDS: Sexually Transmitted Disease Screening for Chlamydia, Gonorrhea, and Syphilis: Percentage of patients aged 13 years an d older with a diagnosis of HIV/AIDS for whom chlamydia, gonorrhea and sy philis screenings were perform ed at least once since the diagnosis of HIV infection AMA-PCPI/NCQA

0028/226 Preventive Care and Screening: Tobacco Use: Screening and Cessation Intervention: Percentage of patients aged 18 years and olde r who were screened for tobacco use one or more times within 24 months AND who rece ived cessation counseling intervention if identified as a tobacco user AMA-PCPI

2082/338 HIV Viral Load Suppression: The percentage of patients, rega rdless of age, with a diagnosis of HIV with a HIV viral load less than 200 copies/mL at last HIV viral load test during the measurement year HRSA

2083/339 Prescription of HIV Antiretroviral Therapy: Percentage of patients, regardless of age, with a diagnosis of HIV prescribed antiretroviral therapy for the treatment of HIV infection during the measurement year HRSA

2079/340 HIV Medical Visit Frequency: Percentage of patients, regardless of age with a diagnosis of HIV who had at least one medical visit in each 6 month period of the 24 month measurement period, with a minimum of 60 days between me dical visits HRSACMS-1612-FC 814

TABLE 70: Inflammatory Bowel Disease (IBD) Measures Group for 2015 and Beyond NQF/ PQRS Measure Title and Description Measure Developer

0041/110 Preventive Care and Screening: Influenza Immunization: Percentage of patients aged 6 months and older seen for a visit between October 1 and March 31 who received an influenza immunization OR who reported previo us receipt of an influenza immunization AMA-PCPI

0043/111 Pneumonia Vaccination Status for Older Adults: Percentage of patients 65 years of age and older who have ever received a pneumococcal vaccine NCQA

0028/226 Preventive Care and Screening: Tobacco Use: Screening and Cessation Intervention: Percentage of patients 18 years and older who were screened for tobacco use one or more times within 24 months AND who received ce ssation counseling intervention if identified as a tobacco user AMA-PCPI

N/A/270 Inflammatory Bowel Disease (IBD): Preventive Care: Corticosteroid Sparing Therapy: Percentage of patients aged 18 years a nd older with a diagnosis of inflammatory bowel disease who have been managed by corticosteroids greater than or equal to 10 mg/day of prednisone equivalents for 60 or gr eater consecutive days or a single prescription equating to 600 mg prednisone or greater fo r all fills that have been prescribed corticosteroid sparing therapy in the last reporting year AGA

N/A/271 Inflammatory Bowel Disease (IBD): Prev entive Care: Corticosteroid Related Iatrogenic Injury – Bone Loss Assessment: Percentage of patients aged 18 years and older with an inflammatory bowel disease encounter who were prescribed prednisone equivalents greater than or equal to 10 mg/day for 60 or greater consecutive days or a single prescription equating to 600 mg prednisone or greater for all fills and were documented for risk of bone loss once during the reporting year or the previous calendar year AGA

N/A/274 Inflammatory Bowel Disease (IBD): Testin g for Latent Tuberculosis (TB) Before Initiating Anti-TNF (Tumor Necrosis Factor) Therapy: Percentage of patients aged 18 years and older with a diagnosis of inflamma tory 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 (tum or necrosis factor) therapy AGA

N/A/275 Inflammatory Bowel Disease (IBD): Assessme nt of Hepatitis B Virus (HBV) Status Before Initiating Anti-TNF (T umor Necrosis Factor) Therapy: Percentage of patients aged 18 years and older with a diagnosis of inflammatory bowel disease (IBD) who had Hepatitis B Virus (HBV) status assessed and re sults interpreted within 1 year prior to receiving a first course of anti-TNF (tumor necrosis factor) therapy AGACMS-1612-FC 815

TABLE 71: Oncology Measures Group for 2015 and Beyond NQF/ PQRS Measure Title and Description Measure Developer

0387/071 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 tamoxife n or aromatase inhibitor (AI) during the 12- month reporting period AMAPCPI/ASCO/NCC N

0385/072 Colon Cancer: Chemotherapy for AJ CC Stage III Colon Cancer Patients: Percentage of patients aged 18 through 80 years with AJCC Stage III colon cancer who are referred for adjuvant chemotherapy, prescribed adjuvant chemotherapy, or have previously received adjuvant chemotherapy within the 12-month reporting period AMAPCPI/ASCO/NCC N

0041/110 Preventive Care and Screening: Influenza Immunization: Percentage of patients aged 6 months and older seen for a visit between October 1 and March 31 who received an influenza immunization OR who reported previo us receipt of an influenza immunization AMA-PCPI

0419/130 Documentation of Current Medications in the Medical Record: Percentage of visits for patients aged 18 years and older for which the eligible professional attests to documenting a list of current medications using all immediate resources available on the date of the encounter. This list must include ALL known pr escriptions, over-the-counters, herbals, and vitamin/mineral/dietary (nutritional) suppl ements AND must cont ain the medications’ name, dosage, frequency and route of administration CMS/QIP

0384/143 Oncology: Medical and Radiation

– Pain Intensity Quantified: Percentage of patients, regardless of patient age, with a diagnosis of cancer currently receiving chemotherapy or radiation therapy in which pain intensity is quantified AMA-PCPI

0383/144 Oncology: Medical and Radiation

– Plan of Care for Pain: Percentage of visits for patients, regardless of age, w ith a diagnosis of cancer curre ntly receiving chemotherapy or radiation therapy who report having pain with a documented plan of care to address pain AMA-PCPI

0028/226 Preventive Care and Screening: Tobacco Use: Screening and Cessation Intervention: Percentage of patients 18 years and older who were screened for tobacco use one or more times within 24 months AND who received ce ssation counseling intervention if identified as a tobacco user AMA-PCPICMS-1612-FC 816

TABLE 72: Optimizing Patient Exposure to Ionizing Radiation Measures Group for 2015 and Beyond NQF/ PQRS Measure Title and Description Measure Developer

N/A/359 Optimizing Patient Exposure to Ionizing Radiation: Utilization of a Standardized Nomenclature for Computed Tomography (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 and the standardized nomenclature is used in institution’s computer systems AMA-PCPI

N/A/360 Optimizing Patient Exposure to Ionizing Radiation: Count of Potential High Dose Radiation Imaging Studies: Computed To mography (CT) and Cardiac Nuclear Medicine Studies: Percentage of computed tomography (CT) and cardiac nuclear medicine (myocardial perfusion studies) imaging reports for all patients, regardless of age, that document a count of known previous CT (any type of CT) and cardiac nuclear medicine (myocardial perfusion) studies that the patient has received in the 12-month period prior to the current study AMA-PCPI

N/A/361 Optimizing Patient Exposure to Ionizing Ra diation: Reporting to a Radiation Dose Index Registry: Percentage of total computed tomogr aphy (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 AMA-PCPI

N/A/362 Optimizing Patient Exposure to Ionizing Radiation: Computed Tomography (CT) Images Available for Patient Follo w-up and Comparison Purposes: Percentage of final reports for computed tomography (CT) studies performed for all patients, regardless of age, which document that Digital Imaging and Co mmunications in Medici ne (DICOM) format image data are available to non-affiliated extern al entities on a s ecure, media free, reciprocally searchable basis with patient authorization for at least a 12-month period after the study AMA-PCPI

N/A/363 Optimizing Patient Exposure to Ionizing Radiation: Search for Prior Computed Tomography (CT) Imaging Studies Through a Secure, Authorized, Media-Free, Shared Archive: Percentage of final reports of computed tomography (CT) studi es performed for all patients, regardless of age, which document that a search for Digital Imaging and Communications in Medicine (D ICOM) format images was conducted for prior patient CT imaging studies completed at non-affiliated extern al healthcare facilities or entities within the past 12-months and are available through a secu re, authorized, media free, shared archive prior to an imaging study being performed AMA-PCPI

N/A/364 Optimizing Patient Exposure to Ionizing Radiation: Appropriateness: Follow-up CT Imaging for Incidentally Detected Pulmonary Nodules According to Recommended Guidelines: Percentage of final reports for CT imaging studies of the thorax for patients aged 18 years and older with documented follow-up recommendations for inci dentally detected pulmonary nodules (for example, follow-up CT imaging studies needed or that no follow-up is needed) based at a minimum on nodul e size AND patient risk factors AMA-PCPICMS-1612-FC 817

TABLE 73: Parkinson’s Disease Me asures Group for 2015 and Beyond NQF/ PQRS Measure Title and Description Measure Developer

0326/047 Care Plan: Percentage of patients aged 65 years a nd older who have an advance care plan or surrogate decision maker documented in the me dical record or documentation in the medical record that an advance care plan was discussed but the patient did not wish or was not able to name a surrogate decisi on maker or provide an advance care plan AMA-PCPI/NCQA

N/A/289 Parkinson’s Disease: Annual Parkin son’s Disease Diagnosis Review: All patients with a diagnosis of Parkinson’s disease who had an a nnual assessment including a review of current medications (for example, medi cations that can produce Parkinson-like signs or symptoms) and a review for the presence of atypical features (for example, falls at presentation and early in the disease course, poor response to le vodopa, symmetry at onset, rapid progression [to Hoehn and Yahr stage 3 in 3 years], lack of tremor or dysautonom ia) at leas t annually AAN

N/A/290 Parkinson’s Disease: Psychiatric Disorders or Disturbances Assessment: All patients with a diagnosis of Parkinson’s disease who were assessed for psyc hiatric disorders or disturbances (for example, psycho sis, depression, anxiety disord er, apathy, or impulse control disorder) at least annually AAN

N/A/291 Parkinson’s Disease: Cognitive Impairment 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 appropria te) who were queried a bout sleep disturbances at least annually AAN

N/A/293 Parkinson’s Disease: Rehabilitative Therapy Options: All patients with a diagnosis of Parkinson’s disease (or caregiver(s), as appr opriate) who had rehabilitative therapy options (for example, physical, occupa tional, 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 Pa rkinson’s disease (or caregiver(s), as appropriate) who had the Parkinson’s diseas e treatment options (for example, nonpharmacological treatment, pharmacological treatment, or surgical treatment) reviewed at least once annually AANCMS-1612-FC 818

TABLE 74: Preventive Care Measures Group for 2015 and Beyond NQF/ PQRS Measure Title and Description Measure Developer

0046/039 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) measurement ordered or performed at least once since age 60 or pharmacologic therapy prescr ibed within 12 months AMAPCPI/NCQA

N/A/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 incontinen ce within 12 months AMAPCPI/NCQA

0041/110 Preventive Care and Screening: Influenza Immunization: Percentage of patients aged 6 months and older seen for a visit between October 1 and March 31 who received an influenza immunization OR who reported previo us receipt of an influenza immunization AMA-PCPI

0043/111 Pneumonia Vaccination Status for Older Adults: Percentage of patients 65 years of age and older who have ever received a pneumococcal vaccine NCQA

N/A/112 Breast Cancer Screening: Percentage of women 50 through 74 years of age who had a mammogram to screen for breast cancer within 27 months NCQA

0034/113 Colorectal Cancer Screening: Percentage of patients 50 through 75 years of age who had appropriate screening fo r colorectal cancer NCQA

0421/128 Preventive Care and Screening: Body Mass Index (BMI) Screening and Follow-Up Plan: Percentage of patients aged 18 years an d older with a BMI documented during the current encounter or during the previous si x months AND with a BMI outside of normal parameters, a follow-up plan is documented du ring the encounter or during the previous six months of the current encounter Normal Parameters: Age 65 years and older BMI ≥ 23 and < 30 kg/m 2 ; Age 18 – 64 years BMI ≥ 18.5 and < 25 kg/m 2 CMS/QIP

0418/134 Preventive Care and Screening: Screening for Clinical Depression and Follow-Up Plan: Percentage of patients aged 12 years and older screened for clinical depression on the date of the encounter using an age appropriate st andardized depressi on screening tool AND if positive, a follow-up plan is document ed on the date of the positive screen CMS/QIP

AQA Adopted/173 Preventive Care and Screening: Unhealthy Alcohol Use

– Screening: Percentage of patients aged 18 years and older who were sc reened for unhealthy alc ohol use at least once within 24 months using a sy stematic screening method** Please note that CMS had proposed to remove this measure from the pr ogram and thus this measure group as a result in th e NPRM. However, as noted above in Table 55, CMS is not finalizing its proposal to re move this measure, and as su ch, the measure is not being removed from this m easure group either. AMA-PCPI

0028/226 Preventive Care and Screening: Tobacco Use: Screening and Cessation Intervention: Percentage of patients 18 years and older who were screened for tobacco use one or more times within 24 months AND who received ce ssation counseling intervention if identified as a tobacco user AMA-PCPICMS-1612-FC 819

TABLE 75: Rheumatoid Arthritis (RA) Measures Group for 2015 and Beyond NQF/ PQRS Measure Title and Description Measure Developer

0054/108 Rheumatoid Arthritis (RA): Disease Mo difying Anti-Rheumat ic Drug (DMARD) Therapy: Percentage of patients aged 18 years a nd older who were diagnosed with RA andwere prescribed, dispensed, or administered at least one ambulatory prescription for a diseasemodifying anti-rheumatic drug (DMARD) NCQA

0421/128 Preventive Care and Screening: Body Mass Index (BMI) Screening and Follow-Up Plan: Percentage of patients aged 18 years and ol der with a BMI documented during the current encounter or during the previous six months AND with a BMI outside of normal parameters, a follow-up plan is documented during the encoun ter or during the previous six months of the current encounter Normal Parameters: Age 65 years and older BMI ≥ 23 and < 30 kg/m 2 ; Age 18 – 64 years BMI ≥ 18.5 and < 25 kg/m 2 CMS/QIP

0420/131 Pain Assessment and Follow-Up: Percentage of visits for patients aged 18 years and older with documentation of a pain assessment usi ng a standardized tool (s) on each visit AND documentation of a follow-up plan when pain is present CMS/QIP

N/A/176 Rheumatoid Arthritis (RA): Tuberculosis Screening: Percentage of patients aged 18 years and older with a diagnosis of rheumatoid arthritis (RA) who have documentation of a tuberculosis (TB) screening performed and re sults interpreted within 6 months prior to receiving a first course of therapy using a biologic disease-modifyi ng anti-rheumatic drug (DMARD) AMA-PCPI

N/A/177 Rheumatoid Arthritis (RA): Periodic Assessment of Disease Activity: Percentage of patients aged 18 years and older with a diagnos is of rheumatoid arthritis (RA) who have an assessment and classification of di sease activity within 12 months AMA-PCPI

N/A/178 Rheumatoid Arthritis (RA): Fu nctional Status Assessment: Percentage of patients aged 18 years and older with a diagnosis of rheumatoid arthritis (RA) for whom a functional status assessment was performed at least once within 12 months AMA-PCPI

N/A/179 Rheumatoid Arthritis (RA): Assessment a nd Classification of Disease Prognosis: Percentage of patients aged 18 years and older wi th a diagnosis of rheumatoid arthritis (RA) who have an assessment and classification of disease prognosis at least once within 12 months AMA-PCPI

N/A/180 Rheumatoid Arthritis (RA): Glucocorticoid Management: Percentage of patients aged 18 years and older with a diagnosis of rheumatoid arthritis (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 AMA-PCPICMS-1612-FC 820

TABLE 76: Sinusitis Measures Group for 2015 and Beyond NQF/ PQRS Measure Title and Description Measure Developer

0419/130 Documentation of Current Medications in the Medical Record: Percentage of visits for patients aged 18 years and older for which the eligible professional attests to documenting a list of current medications using all immediate resources available on the date of the encounter. This list must include ALL known pr escriptions, over-the-counters, herbals, and vitamin/mineral/dietary (nutritional) suppl ements AND must cont ain the medications’ name, dosage, frequency and route of administration CMS/QIP

0420/131 Pain Assessment and Follow-Up: Percentage of visits for patients aged 18 years and older with documentation of a pain assessment usi ng a standardized tool (s) on each visit AND documentation of a follow-up plan when pain is present CMS/QIP

0028/226 Preventive Care and Screening: Tobacco Use: Screening and Cessation Intervention: Percentage of patients 18 years and older who were screened for tobacco use one or more times within 24 months AND who received ce ssation counseling intervention if identified as a tobacco user AMA-PCPI

N/A/331 Adult Sinusitis: Antibiotic Prescribed for Acute Sinusitis (Appropriate Use): Percentage of patients, aged 18 years and ol der, with a diagnosis of acute sinusitis who were prescribed an antibiotic within 7 days of diagnosis or within 10 days after onset of symptoms AMA-PCPI

N/A/332 Adult Sinusitis: Appropriate Choice of Antibiotic: Amoxicillin Prescribed for Patients with Acute Bacterial Sinusitis: Percentage of patients aged 18 years and older with a diagnosis of acute bacterial si nusitis that were pr escribed amoxicillin , with or without clavulante, as a first line antibi otic at the time of diagnosis AMA-PCPI

N/A/333 Adult Sinusitis: Computerized Tomogr aphy for Acute Sinusitis (Overuse): Percentage of patients aged 18 years and older with a diagnosis of acute sinusitis who had a computerized tomography (CT) scan of th e paranasal sinuses ordered at the time of diagnosis or received within 28 days after date of diagnosis AMA-PCPICMS-1612-FC 821

TABLE 77: Sleep Apnea Measures Group for 2015 and Beyond (Please note that CMS initially proposed to remove this measure group contingent on the measure steward not being able to maintain certain measures contained in this measures group. A new steward has been identified for the measures at risk and for this reason CMS is not finalizing its proposal to remove this measures group in 2015.)

NQF/ PQRS Measure Title and Description Measure Developer

0421/128 Preventive Care and Screening: Body Mass Index (BMI) Screening and Follow-Up Plan: Percentage of patients aged 18 years an d older with a BMI documented during the current encounter or during the previous si x months AND with a BMI outside of normal parameters, a follow-up plan is documented du ring the encounter or during the previous six months of the current encounter Normal Parameters: Age 65 years and older BMI ≥ 23 and < 30 kg/m 2 ; Age 18 – 64 years BMI ≥ 18.5 and < 25 kg/m 2 CMS/QIP

0419/130 Documentation of Current Medications in the Medical Record: Percentage of visits for patients aged 18 years and older for which the eligible professional attests to documenting a list of current medications using all immedi ate resources available on the date of the encounter. This list must include ALL known pr escriptions, over-the-counters, herbals, and vitamin/mineral/dietary (nutr itional) supplements AND must c ontain the medications’ name, dosage, frequency and route of administration CMS/QIP

0028/226 Preventive Care and Screening: Tobacco Use: Screening and Cessation Intervention: Percentage of patients 18 years and older who were screened for tobacco use one or more times within 24 months AND who received cessa tion counseling intervention if identified as a tobacco user AMA-PCPI

N/A/276 Sleep Apnea: Assessment of Sleep Symptoms: Percentage of visits for patients aged 18 years and older with a diagnosis of obstructive sleep apnea that include s documentation of an assessment of sleep symptoms, including pres ence or absence of snoring and daytime sleepiness AMA-PCPI/NCQA

N/A/277 Sleep Apnea: Severity Asse ssment 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 (RD I) measured at the time of initial diagnosis AMA-PCPI/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 AMA-PCPI/NCQA

N/A/279 Sleep Apnea: Assessment of Adherence to Positive Airway Pressure Therapy: Percentage of visits fo r patients aged 18 years and older w ith a diagnosis of obstructive sleep apnea who were prescribed positive airway pr essure therapy who had documentation that adherence to positive airway pressure therapy was objectively measured AMA-PCPI/NCQACMS-1612-FC 822

TABLE 78: Total Knee Replacement (TKR) Measures Group for 2015 and Beyond NQF/ PQRS Measure Title and Description Measure Developer

0419/130 Documentation of Current Medications in the Medical Record: Percentage of visits for patients aged 18 years and older for which the eligible professional attests to documenting a list of current medications using all immedi ate resources available on the date of the encounter. This list must include ALL known pr escriptions, over-the-counters, herbals, and vitamin / mineral / dietary (nutritional) s upplements AND must cont ain the medications’ name, dosage, frequency and route of administration CMS/QIP

0028/226 Preventive Care and Screening: Tobacco Use: Screening and Cessation Intervention: Percentage of patients 18 years and older who were screened for tobacco use one or more times within 24 months AND who received cessa tion counseling intervention if identified as a tobacco user AMA-PCPI

N/A/350 Total Knee Replacement: Shared Decision-Making: Trial of Conservative (Nonsurgical) Therapy: Percentage of patients regardless of age or gender undergoing a total knee replacement with documented shared decision-making with discussion of conservative (non-surgical) therapy (or exampl e, NSAIDS, analgesics, weight loss, exercise, injections) prior to the procedure AAHKS

N/A/351 Total Knee Replacement: Venous Thro mboembolic and Cardiovascular Risk Evaluation: Percentage of patients regardless of age or gender 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(for example, history of Deep Vein Thrombosis, Pulmonary Em bolism, Myocardial Infarction, Arrhythmia and Stroke) and Stroke AAHKS

N/A/352 Total Knee Replacement: Preoperative Anti biotic Infusion with Proximal Tourniquet: Percentage of patients regardless of age underg oing a total knee re placement who had the prophylactic antibiotic completely infused prio r to the inflation of the proximal tourniquet AAHKS

N/A/353 Total Knee Replacement: Identification of Implanted Prosthesis in Operative Report: Percentage of patients regardless of age or gender undergoing total knee replacement whose operative report identifies the prosthetic implant specifications including the prosthetic implant manufacturer, the brand name of the pros thetic implant and the size of prosthetic implant AAHKS

e. Measures Available for Reporting in the GPRO Web Interface

We finalized the measures that are available fo r reporting in the GPRO web interface for 2014 and beyond in the CY 2013 PFS final rule (77 FR 69269). However, we propo sed to remove and add

measures in the GPRO web interface measure set as reflected in Tables 47 and 48 in the CY 2015 PFS proposed rule for 2015 and beyond (79 FR 40468). Specifically, Table 47 specified the measures we proposed to remove for reporting from the GPRO web interface, and Table 48 specified the measures we proposed to add for reporting in the GPRO web in terface. CMS proposed to adopt Depression Remission at Twelve Months (NQF #0710) in the 2015 GPRO Web Interface reporting op tion for ACOs and group practices (79 FR 40469). This measure is currently reportable in the PQRS program through the EHR reporting option only and has not been tested using claims level data or sampling methodology. Depression Remission at Twelve Months (NQF #0710) requires a look-back period and a look-forward period possibly spanning multiple calenda r years. Additionally, this measure requiresCMS-1612-FC 823

utilization of a PHQ-9 depression screening tool with a score greater than 9 and a diagnosis of depression/dysthymia to identify the beginning of th e episode (initial patient population). Successful completion of the quality action for this measure looks for a PHQ-9 score of less than 5 at the twelve month mark (plus or minus 30 days) from the initial onset of the episode. CMS solicited comments regarding these proposals, and the comment s are addressed in Tables 79 and 80.CMS-1612-FC 824

TABLE 79: Measures Being Removed from the Gr oup Practice Reporting Option Web Interface Beginning in 2015 and BeyondNQF/PQRS GPRO Module NQS Domai n Measure and Title Description ¥MeasureStewardOther QualityReportingPrograms

Measures Finalized as Proposed 0097/ 046 Care Coordinatio n/ Patient Safety Patient Safety Medication Reconciliation: Percentage of patients aged 65 years and older discharged from any inpatient facility (for example, hospital, skilled nursing facility, or rehabilitation facility) and seen within 30 days following discharge in the office by the physician, prescrib ing practitioner, registered nurse, or clinical pharmacist providing on-going care who had a reconciliation of the discharge medications with the current medication list in the outpatient medical record documented Several commenters agreed with CMS’ proposal to remove this measure, noting “full medication reconciliation sh ould be done at least annually with a ll patients.” However, other commenters disagreed, indicating this measure “specifically evaluates the medication reconciliation during a time period when patients are most vulnerable during a time of transitions of care that may result in adverse consequences to the patient including preventable readmission to the hospital.” However, CMS continues to believe NQF #0419 Do cumentation of Medications in the Medical Record is a more robust and broadly applicable measure. Furthermore, there have been implementation issues with this measure in the web interface, despite CMS believing this is a valuable measure. Fina lly, CMS is continuing to work to align the GPRO with the EHR Incentive Programs, and NQF #0419 is in the Incentive Progr am, whereas PQRS #046 is not. For these reasons, CMS is finali zing its proposal to remove this measure from reporting through the GPRO WI in 2015 PQRS and the Shared Savings Program. AMAPCPI/NCQ A

0074/ 197 Coronary Artery Disease Effectiv e Clinical Care 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 < 100 mg/dL, including at a minimum the prescription of a statin While some commenters disagreed with CMS’s proposal to remove this measure “unless or until new measures that are more consistent with new and existing guidelines are put in place to replace them”, several commenters supported the proposal to retire this and the two other lipid control measures listed as a result of new clinical guidelines released in 2013 by the American College of Cardiology and American Heart Association. For this reason, CM S is finalizing its proposal to remove this measure from reporting in 2015 PQRS and the Shared Savings Program. AMAPCPI/ ACCF/ AHACMS-1612-FC 825NQF/PQRS GPRO Module NQS Domai n Measure and Title Description ¥MeasureStewardOther QualityReportingPrograms

0729/ 319 Diabetes Mellitus Effectiv e Clinical Care 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: ● Diabetes Mellitus: High Blood Pressure Control. ● Diabetes Mellitus: Low Density Lipoprotein (LDL-C) Control. ● Diabetes Mellitus: Hem oglobin A1c Control (< 8%). ● Diabetes Mellitus: Tobacco Non-Use CMS proposed retiring 4 component s of the 5 part diabetes composite measure as noted above. Specifically, commenters: ● Disagreed with removing the blood pressure component, noting “important that diabetic pa tients have their blood pressure and cholesterol monitored in order to prevent co-morbidities; if assessing quality of their care is folded into the general Medicare patient population, the focus on th eir care and desirable health care outcomes is effectively “watered down.” However, other commenters supported this change noting “a measure that is based on a specific A1c level is no longer an accurate measure of a physician’s ability to provide high quality care for their patients.” CMS agrees this measure may no longer be the best measure of quality care in this area. Further, CMS continues to believe this measure is somewh at duplicative of the measure Controlling High Blood Pressure (NQF #0018) and that the diabetes measure may capture a subpopulation of the broader Controlling High Blood Pressure measure. ● Agreed with removing the LD L component as a result of new clinical guidelin es released in 2013 by the American College of Cardiology and American Heart Association (https://circ.ahajournals.org/c ontent/early/2013/11/11/01.cir.0000 437738.63853.7a.full.pdf). ● Agreed with removing the Hemoglobin A1c Control (<8%) component, noting it is “t oo restrictive for a small cohort of patients and not restrictive enough for the majority of patients.” ● Disagreed with removing the Tobacco Non-Use component, noting “this outcome based measure (as opposed to the screening and counseling meas ure) is not only a critical measure for diabetic best ma nagement, but removing it is stepping away from a known shared goal of moving towards outcome based measures.” However, other commenters supported this change nothing that this measure, in addition to other measures, “were either duplicative of other measures or the guidelines for the measure have been changed.” CMS continues to believe this component is somewhat duplicative of the Tobacco Screening and Cessation Counseling measure (NQF 0028) and NQF 0028 is more broadly applicable. For these reasons, CMS is finali zing its proposal to remove these four components of the diab etes composite measure from reporting in 2015 PQRS and the Shared Savings Program. MNCMCMS-1612-FC 826NQF/PQRS GPRO Module NQS Domai n Measure and Title Description ¥MeasureStewardOther QualityReportingPrograms

0075/ 241 Ischemic Vascular Disease Effectiv e Clinical Care Ischemic Vascular Disease (I VD): Complete Lipid Profile and LDL-C Control (< 100 mg/dL): 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 coronary interventions (PCI) in the 12 months prior to the measurement period, or who had an active diagnosis of ischemic vascul ar disease (IVD) during the measurement period, and who ha d each of the following during the measurement period: a complete lipid profile and LDL-C was adequately controlled (< 100 mg/dL) Commenters supported the proposal to retire this lipid control related measure because of the new clinical guidelines for statin treatment, as discussed for other LDL measures in this table. For this reason, CMS is finalizing its proposal to remove this measure from reporting in 2015 PQ RS and the Shared Savings Program. NCQA MU2 Millio n Hearts

Measures Not Finalized as Proposed 0068/ 204 Ischemic Vascular Disease Effectiv e Clinical Care 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 coronary interventions (PCI) in the 12 months prior to the measurement period, or who had an active diagnosis of ischemic vascular disease (IVD) during the measurement period and who had documentation of use of aspirin or another antithrombotic during the measurement period CMS received comments about this measure being proposed for removal from the Web Interface for PQRS and the Shared Savings Program. Some commenter s requested clarification of CMS’s previous concern that th e measure may not align with current guidelines when proposing its removal. After reviewing the measure further, we have determined the measure does not conflict with current guidelin es the updated ATP-4 cholesterol guidelines, which have gone away from focusing on specific LDL targets, but do not impact this measure as previously thought. This measure is also a core measure for the Million Hearts Initiative. It is CMS’s in tent to maintain alignment with other quality reporting programs and HHS Initiatives. CMS also received comments supporting the removal of the measure from the Shared Savings Program, but requesting clarification of guideline changes impacting the measureTherefore, CMS will maintain alignment with the Million Hearts program and for this reason CMS is retaining this measure and it will be available for reporting through the GPRO WI in 2015 PQRS and the Shared Savings Program. NCQA MU2 Millio n HeartsCMS-1612-FC 827NQF/PQRS GPRO Module NQS Domai n Measure and Title Description ¥MeasureStewardOther QualityReportingPrograms

0729/ 319 Diabetes Mellitus Effectiv e Clinical Care 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:

● Diabetes Mellitus: Daily Oral Aspirin or Antiplatelet Medication Use for Patients with Diabetes and Ischemic Vascular Disease CMS did not originally propose to remove this measure. However, this measure was reported in the PQRS as a component of the diabetes comp osite reportable via the GPRO Web Interface. We note that, while we did not originally propose to remove this measure, we proposed to remove all of the other components of the diab etes composite of which this measure was a part. Specifically , we proposed to remove the following components of the diabetes composite: • Diabetes Mellitus: High Blood Pressure Control. • Diabetes Mellitus: Low Density Lipoprotein (LDL-C) Control. • Diabetes Mellitus: Hemoglobin A I c Control ( < 8% ). • Diabetes Mellitus: Tobacco Non-Use Since we proposed to remove all other components of the diabetes composite listed above, we believe the public could reasonably foresee that we would remove this measure from the PQRS and Shared Savings Progr am measure set if all other components of the diabetes co mposite were removed. In addition, CMS believes the Daily Oral Aspirin component of this measure may be somewhat duplic ative of PQRS #204 (Ischemic Vascular Disease (IVD): Use of Aspirin or Another Antithrombotic). Therefore, we are removing this measure from the PQRS measure set. To maintain alignment with PQ RS and reduce reporting burden for ACOs, we are also removing this measure from the Shared Savings Program measure set. CM S believes that removing this measure will reduce burden on AC Os and allow them to improve their performance on the diabet es composite by reducing the number of measures incl uded in the composite. Therefore, for the reasons stat ed above, we are removing this measure from the PQRS and Shared Savings Program measure set beginning in 2015 MNCMCMS-1612-FC 828

TABLE 80: New Measures That Will Be Available for Reporting by the Group Practice Reporting Option Web Interface Beginning in 2015 and Beyond f. The Clinician Group (CG) Consumer Assessme nt of Healthcare Providers and Systems (CAHPS) Survey

In the CYNQF/PQRS GPRO Module NQS Domain Measure and Title Description ¥MeasureStewardOtherQualityReportingProgram

Measures Finalized as Proposed 0059/ 001 Diabetes Mellitus Effective Clinical Care Diabetes: Hemoglobin A1c Poor Control: Percentage of patients 18-75 years of age w ith diabetes who had hemoglobin A1c > 9.0% during the measurement period The Shared Savings Program and PQRS received many comments supporting removal of the Diabetes: Hemogolobin A1c control (<8 percent) (ACO-22), since <8 percent seems restrictive. CMS received so me comments suggesting we move toward more outcome measures th an process measures. CMS is finalizing its proposal to in clude this measure in the new Diabetes Management (DM) com posite as a more appropriate A1c component for reporting in 2015 PQRS and the Shared Savings Program. This meas ure, Hemogolobin A1c Poor Control is being finalized because it addresses a clinically important area for diabetic patients and replaces the previous measure in the DM composite. NCQA MU2

0055/ 117 Diabetes Mellitus Effective Clinical Care Diabetes: Eye Exam: Percentage of patients 18 through 75 years of age with a diagnosis of diabetes (type 1 and type 2) who had a retinal or dilated eye exam by an eye care professional in the measurement period or a negative retinal or dilated eye exam (negative for retinopathy) in the year prior to the measurement period Several commenters supported the addition of this measure to the GPRO WI for PQRS and the Shared Savings Program, noting eye exams are an important part of quality care for diabetic patients. CMS also received some comments suggesting that we not finalize additional process measures and questioning the improvement to outcomes, noting while “foot and eye exams are an important part of good diabetes care, we recommend that they not replace the current outcomes measures in the Diabetes Composite measure set.” CMS agrees foot and eye exams are a valuable addition that reflect good diabetes care. Please see Table 79 for additional discussion of the rationale for the removal of the previous diabetes composite. CMS is finalizing its proposal to include this measure in the new Diabetes Management composite in the GPRO WI for reporting in 2015 PQRS and Shared Savings Program due to the clinical importance of the meas ure and alignment of programs. NCQA MU2CMS-1612-FC 829NQF/PQRS GPRO Module NQS Domain Measure and Title Description ¥MeasureStewardOtherQualityReportingProgram

0419/ 130 Care Coordinati on/ Patient Safety Patient Safety Documentation of Current Medications in the Medical Record: Percentage of visits for patients aged 18 years and older for which the eligible pr ofessional attests to documenting a list of current medications using all immediate resources available on the date of the encounter. This list must include ALL known prescriptions, over-the-counters, herbals, and vitamin/mineral/dietary ( nutritional) supplements AND must contain the medications’ name, dosage, frequency and route of administration While some commenters disagreed with the addition of this measure, others suggested medi cation reconciliation should be performed at all office visits a nd not just those visits occurringafter an inpatient discharge. Furthermore, the steward of CARE1 (PQRS #46) Medication Reconciliation: Reconciliation After Discharge from an Inpatient Facility indicated this measure is not appropriate for the GPRO WI reporting mechanism. Some commenters recommended limiti ng documentation of current medications to only the last visit due to potential reporting burden. We disagree with the comment ers who disagree with the addition of this measure. We believe this measure adequately captures an important aspect of patient safety – the need to understand a patient’s current medications. We believe documenting current medications is key to determining the most appropriate care for a patient. With respect to the commenters who believed that medicati on reconciliation should be performed on all office visits, please note that the title and description of the measure doe s not limit this measure to documentation after an inpatient di scharge. With respect to a measure steward’s concern that this measure is not appropriate for the GPRO WI reporting mechanism, we disagree with the measure steward. As we note above, we believe this measure is appropriate for the GPRO WI as it captures an important aspect of patient safety.

Based on the comments received and for the reasons stated above, CMS is finalizing its prop osal to replace PQRS #46 with PQRS #130 Documentation of Current Medications in the Medical Record for reporting in the GPRO WI in 2015 PQRS and Shared Savings Program and will consider reporting burden in finalizing specificat ions for GPRO reporting. CMS/QI P MU2CMS-1612-FC 830NQF/PQRS GPRO Module NQS Domain Measure and Title Description ¥MeasureStewardOtherQualityReportingProgram

0710/ 370 Mental Health Effective Clinical Care Depression Remission at Twelve Months: Adult patients age 18 and older with major depression or dysthymia and an initial PHQ-9 score > 9 who demonstrat e 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. Several commenters for PQRS a nd the Shared Savings Program expressed concern over use of the PHQ-9, indicating not all practices use this tool. CMS appreciates commenter feedback and concerns regarding issues with the use of PHQ-9. CMS recognizes there may be EPs repo rting who do not currently use this tool and because of the look back period may not be able to implement this tool in time for the next reporting period, and as such CMS is considered adjustme nts to how this measure will be reported, specifically for the Shared Savings Program. CMS continues to believe this Depression Remission measure represents an important outcome . Depression ma nagement is particularly important due the ef fects on patient adherence with treatment for other chronic conditions. For these reasons, CMS is finalizing its proposal to ma ke this measure reportable through the GPRO WI in 2015 PQRS and the Shared Savings Program. Given the comments a nd concerns raised regarding the use of the PHQ-9 tool and providing ACOs with time to make necessary adjustments for implementation, the measure will be designated as pay-for-reporting under the Shared Savings Program for all 3 years of an ACO’s first agreement period, as specified in the program’s final measure set. MNCM MU2

Measures Not Finalized as Proposed 0067/ 006 Coronary Artery Disease Effective Clinical Care Coronary Artery Disease (CAD): Antiplatelet Therapy: Percentage of patients aged 18 years and older with a diagnosis of coronary artery disease (CAD) seen within a 12 month period who were prescribed as pirin or clopidogrel. Commenters agreed with the addition of this measure, but recommended testing the compos ite and maintaining as only pay-for-reporting for the Shared Savings Program. Other commenters did not agree with including this measure due to concerns that the composite has not been reviewed by NQF and has not been tested before implementation. CMS agrees this measure needs to be tested as part of the composite prior to implementation and as such, CMS is not finalizing its proposal to include this measure for re porting in for the PQRS GPRO web interface and Shared Savings Program. AMAPCPI/ ACCF/ AHA MU2

0070/ 007 Coronary Artery Disease Effective Clinical Care Coronary Artery Disease (CAD): Beta-Blocker Therapy – Prior Myocardial Infarction (MI) or Left Ventricular Systolic Dysfunction (LVEF < 40%): Percentage of patients aged 18 years and older with a diagnosis of coronary artery disease seen within a 12 month period who also have prior MI OR a current or LVEF < 40% who were prescribed beta-blocker therapy Some commenters agreed with the addition of this measure while others did not agree with including this measure and suggested testing and submission to NQF. We also believe this measure is topped out. Therefor e, CMS is not finalizing its proposal to include this measur e for reporting for the PQRS and Shared Savings Program GPRO web interface. AMAPCPI/ ACCF/ AHA MU2CMS-1612-FC 831NQF/PQRS GPRO Module NQS Domain Measure and Title Description ¥MeasureStewardOtherQualityReportingProgram

0056/ 163 Diabetes Mellitus Effective Clinical Care Diabetes: Foot Exam: Percentage of patients aged 18-75 years of age with diabetes who had a foot exam during the measurement period While several commenters suppor ted the addition of this measure, many commenters did not support the inclusion of this process measure and suggested fu rther testing of the composite as well as identifying the link to improved outcomes. Furthermore, CMS believes the measures that are being finalized for the Diabetes Co mposite represent a robust, outcome focused set of measur es with room for quality improvement. Therefore, CMS is not finalizing its proposal to make this measure reportable through the GPRO WI in 2015 PQRS and the Shared Savings Program. NCQA MU2

N/A/ 242 Coronary Artery Disease Effective Clinical Care Coronary Artery Disease (CAD): Symptom Management: Percentage of patients aged 18 years and older with a diagnosis of coronary artery disease (CAD) seen within a 12 month period with results of an evaluation of level of activity and an assessment of whether anginal sy mptoms are present or absent with appropriate management of anginal symptoms within a 12 month period Some commenters agreed with CMS’ proposal to include this measure in the GPRO WI. However, most commenters did not support including the measure due to lack of NQF endorsement and the reporting burden/challenges if the measure is finalized. Due to the comments received not supporting the measure due to reporting burden, CMS is not finalizing its proposal to include this measure for reporting in 2015 PQRS and Shared Savings Program GPRO web interface. AMAPCPI/ ACCF/ AHA

0729/ 319 Diabetes Mellitus Effective Clinical Care 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:

● Diabetes Mellitus: Daily Oral Aspirin or Antiplatelet Medication Use for Patients with Diabetes and Ischemic Vascular Disease

As discussed in Table 79 above , CMS believes the Daily Oral Aspirin component of this measure may be somewhat duplicative of PQRS #204, AC O-30 (Ischemic Vascular Disease (IVD): Use of Aspirin or Another Antithrombotic). Furthermore, upon further review and with CMS’s intent to maintain alignment with othe r quality reporting programs and limit the number of potentially duplicative measures that may cause additional reporting burden, CMS is removing this measure from the PQRS and Shared Savings Program measure sets. MNCM

f. The Clinician Group (CG) Consumer Assessme nt of Healthcare Providers and Systems (CAHPS) Survey

In the CY 2014 PFS final rule with comment period, we finalized the CG-CAHPS survey available for reporting under the PQRS for 2014 and beyond (78 FR 74750 through 74751), to which weCMS-1612-FC 832

are now referring as the CAHPS for PQRS. Please no te that, in the CY 2014 PFS final rule with comment period, we classified the CAHPS for PQRS survey under the care coordination and communication NQS domain. We noted that this was an error on our part, as the CAHPS for PQRS survey has typically been classified under the Pe rson and Caregiver-Centere d Experience and Outcomes domain as the CAHPS for PQRS survey assesses beneficiary experience of care and outcomes. Therefore, as we indicated in Table 21 of the CY 2015 proposed rule, we proposed to reclassify the CAHPS for PQRS survey under the Person and Caregi ver-Centered Experience and Outcomes domain. We invited public comment on this proposal. Pl ease note that the comments on this proposal are addressed in Table 54, where the domain change fo r CAHPS for PQRS as well as other PQRS measures

is indicated. 6. Statutory Requirements and Ot her Considerations for the Selection of PQRS Quality Measures for Meeting the Criteria for Satisfactory Participa tion in a QCDR for 2014 and Beyond for Individual Eligible Professionals For the measures which eligible professionals pa rticipating in a QCDR must report, section 1848(m)(3)(D) of the Act, as amended and added by section 601(b) of the ATRA, provides that the Secretary shall treat eligible professionals as satis factorily submitting data on quality measures if they satisfactorily participate in a QCDR. Section 1848(m )(3)(E) of the Act, as added by section 601(b) of the ATRA, provides some flexibility with regard to th e types of measures applicable to satisfactory participation in a QCDR, by specifying that for measures used by a QCDR, sections 1890(b)(7) and 1890A(a) of the Act shall not apply, and measures endorsed by the entity with a contract with the Secretary under section 1890(a) of the Act may be used. In the CY 2014 PFS final rule with comment peri od, we finalized requirements related to the parameters for the measures that would have to be reported to CMS by a QCDR for the purpose of its individual eligible professionals meeting the criteria fo r satisfactory participatio n under the PQRS (78 FR 74751 through 74753). Although we did not propose to remove any of the requirements we finalized related to these parameters, we proposed to modify the following parameters we finalized in the CY 2014CMS-1612-FC 833

PFS final rule with comment period related to measu res that may be reported by a QCDR (79 FR 40472 through 40473):

● The QCDR must have at least 1 outcome me asure available for reporting, which is a measure that assesses the results of health care that are experi enced by patients (that is, patients’ clinical events; patients’ recovery and health status ; patients’ experiences in the health system; and efficiency/cost). As we proposed that for an eligible professional to meet the criterion for satisfactory participation in a QCDR for the 2017 PQRS payment adjustment, the eligible professional must report on at least 3 outcome measures or, in lieu of 3 outcome measures, at least 2 outcome measures and 1 resource use, patient experience of care, or efficiency/appropriate use measure, we modified this requirement to conform to this satisfactory particip ation criterion. Therefore, we proposed that a QCDR must have at least 3 outcome measures available for reporting, whic h is a measure that assesses the results of health care that are experienced by patients (that is, patients’ c linical events; patients’ recovery and health status; patients’ experiences in the health system; and effici ency/cost). In lieu of having 3 outcome measures available for reporting, the QCDR must have at l east 2 outcome measures available for reporting and at least 1 resource use, patient experience of care, or efficiency/appropriate use measure (79 FR 40473). We solicited and received the following comments on this proposal: Comment: As the majority of commenters opposed our proposal to require the reporting of 3

outcomes measures to meet the criteria for satisf actory participation for the 2017 PQRS payment adjustment, for the same reasons, the majority of co mmenters also opposed our proposal to require that a QCDR must have at least 3 outcome measures availabl e for reporting, or, in lieu of 3 outcome measures, a QCDR have at least 2 outcome measures available for reporting and at least 1 resource use, patient experience of care, or efficiency/appropriate use measure. The commenters believed this proposed requirement was overly burdensome for QCDRs. Response: We responded to the commenters’ con cerns regarding our proposal to require the reporting of 3 outcomes measures to meet the criteria for satisfactory participation for the 2017 PQRS payment adjustment at III.K.3.a. For the same reas ons discussed in that section, we are modifying our proposal to require that a QCDR must have at least 3 outcome measures available for reporting, or, in lieuCMS-1612-FC 834

of 3 outcome measures, a QCDR have at least 2 outcome measures available for reporting and at least 1 resource use, patient experience of care, or efficien cy/appropriate use measure. To correspond with the final criteria for the satisfactory participation fo r the 2017 PQRS payment adjustment, for 2015 and beyond, we are modifying this proposal to require that a QCDR have at least 2 outcome measures available for reporting. An outcomes measure is a meas ure that assesses the results of health care that are experienced by patients (that is, patients’ clinical even ts; patients’ recovery and health status; patients’ experiences in the health system; and efficiency/cost) . In lieu of having 2 outcomes measures available for reporting, the QCDR must at least have 1 outcome measure available for reporting and at least 1 resource use, patient experience of care, efficiency/a ppropriate use measure, or patient safety measure. We believe this is an appropriate modification, as QCDRs that only have the ability to report 1 outcome measure may still report 1 outcome measure as long as the QCDR has another measure (resource use, patient experience of care, efficiency/appropriate u se measure, or patient safety measure) in another domain available for reporting. We proposed to define resource use, patient expe rience of care, or efficiency/appropriate use measures in the following manner (79 FR 40473):

● A resource use measure is a measure that is a comparable measure of actual dollars or standardized units of resources applied to the care given to a specific population or event, such as a specific diagnosis, procedure, or type of medical encounter. We did not receive any comments on this proposed definition of a resource use measure. As such , we are finalizing this definition of a resource use measure as proposed.

● A patient experience of care measure is a me asure of person- or family-reported experiences (outcomes) of being engaged as active members of the health care team and in collaborative partnerships with providers and pr ovider organizations. We did not receive any comments on this proposed definition of a patient experience of care measure. As such, we are finalizing this definition of a patient experience of care measure as proposed.

● An efficiency/appropriate use measure is a measure of the appropriate use of health care services (such as diagnostics or therapeutics) based upon evidence-based guidelines of care, or for whichCMS-1612-FC 835

the potential for harm exceeds the possible benefits of care. We did not receive any comments this proposed definition of an efficiency/appropriate use meas ure. As such, we are finalizing this definition of an efficiency/appropriate use measure as proposed. Please note that, for purposes of meeting the criteria for satisfactory participation in a QCDR, we allow QCDRs to report on any measure if it meets the me asure parameters we finalize. We noted that we would allow and encourage the reporting of the Cons umer Assessment of Healthcare Providers Surgical Care Survey (S-CAHPS) through a QCDR. Finally, in the CY 2014 PFS final rule with comment period, we stated that a QCDR must provide to CMS descriptions and narrative specificati ons for the measures for which it will report to CMS by no later than March 31, 2014. In keeping with th is timeframe, we proposed that a QCDR must provide to CMS descriptions for the measures for which it will re port to CMS for a particular year by no later than March 31 of the applicable reporting period for which the QCDR wishes to submit quality measures data.

We solicited and received the followi ng comments on this proposal:

Comment: Commenters believed that it was reasona ble to require a QCDR to provide to CMS descriptions and narrative specifications for the measur es for which it will report to CMS by no later than March 31, 2014. Response: We appreciate the commenters’ fee dback. Based on the comments received, we are finalizing our proposal to require that a QCDR must provide to CMS descriptions for the measures for which it will report to CMS for a particular year by no later than March 31 of the applicable reporting period for which the QCDR wishes to submit quality me asures data. For example, if a QCDR wishes to submit quality measures data for the 2017 PQRS paymen t adjustment (the 12-month reporting period of which occurs in 2015), the QCDR must provide to CMS descriptions for the measures for which it will report to CMS by no later than March 31, 2015. The descriptions must include: name/title of measures, NQF # (if NQF-endorsed), descriptions of the denominat or, numerator, and when applicable, denominator exceptions and denominator exclusions of the measure . The narrative specifications provided must be similar to the narrative specifications we provide in our measures list, available atCMS-1612-FC 836

http://www.cms.gov/apps/ama/license.asp?file=/PQRS /downloads/2014_PQRS_ IndClaimsRegistry_Mea sureSpecs_SupportingDocs_12132013.zip

. Related to this proposal, we proposed that, 15 days following CMS approval of these measure specifications, the QCDR must publicly post the meas ures specifications for the measures it intends to report for the PQRS using any public format it prefer s. Immediately following posting of the measures specification information, the QCDR must provide CMS w ith the link to where this information is posted. CMS will then post this information when it provid es its list of QCDRs for the year. We believe providing this information will further aid in crea ting transparency of reporting. We solicited and received the following comment on this proposal: Comment: Some commenters supported this proposal, as the commenters believe it was reasonable to require that this information be ma de available to the public. The commenters supported our proposal to defer to the QCDR in terms of what platform and in what manne r this data may be made available to the public. Some commenters opposed this proposal based on their concerns that the public reporting requirement was overly burdensome and urge d CMS to delay requiring the posting of measures

data until the measures have been tested for validit y and reliability. The commenters believed that CMS should not make substantial changes in the QCDR requirements, as the QCDR option is new and the

entities need time to familiarize themselves with the QCDR option before new requirements are established. One commenter preferred public repor ting of QCDR quality measures data through a single site so that information would be easily accessibl e and people seeking this information would not be forced to look through multiple sites. Response: With respect to the commenters who oppo sed this proposal and urged us not to make additional changes to the QCDR option while entiti es become more familiar with this option, we understand the commenters’ concerns. However, we belie ve that transparency of data is a key component of a QCDR option. Furthermore, in the CY 2014 PFS final rule, while we did not finalize our proposal that a QCDR have a plan to publicly report quality measures data, we noted that we encouraged QCDRs “to move towards the public reporting of quality measures data” and stated that “[w]e plan to establish such a requirement in the future and will revi sit this proposed requirement as part of CY 2015CMS-1612-FC 837

rulemaking” (78 FR 74471). Therefore, we believe that QCDRs were on notice that we would finalize a requirement to make quality measures data available to the public. With respect to the commenter that preferred this information to be posted on a single site, we note that the Physician Compare website will provide quality measures data information on eligible professionals participating in QCDRs. Therefore, while the QCDRs are free to provid e this information elsewhere, the Physician Compare website will serve as a point where all information will be accessible. Based on the reasons we stated above and in the proposed rule, we are finalizing our proposal to require that, 15 days following CMS approval of these measure specifications, a QCDR must publicly pos t the measures specifications for the measures it intends to report for the PQRS using any public format it prefers. Immediately following posting of the measures specification information, the QCDR must pr ovide CMS with the link to where this information is posted. CMS will then post this information when it provides its list of QCDRs for the year.

7. Informal Review

In the CY 2013 PFS final rule with comment period (77 FR 69289), we established that “an eligible professional electing to utilize the informal re view process must request an informal review by February 28 of the year in which the payment adjustment is being applied. For example, if an eligible professional requests an informal review related to the 2015 payment adjustment, the eligible professional would be required to submit his/her request for an in formal review by February 28, 2015.” As stated in the CY 2013 PFS final rule with comment period, we believed this deadline provided ample time for eligible professionals and group practices after their r espective claims begin to be adjusted due to the payment adjustment. However, because PQRS data is used to establish the qua lity composite of the VM, we believe it is necessary to expand the informal revi ew process to allow for some limited corrections of the PQRS data to be made. Therefore, we proposed to modify the payment adjustment informal review deadline to within 30 days of the release of the feedb ack reports. For example, if the feedback reports for the 2016 payment adjustment (based on data collect ed for 2014 reporting periods) were released on August 31, 2015, an eligible professi onal or group practice would be required to submit a request for an informal review by September 30, 2015. We believe that by being able to notify eligible professionals and group practices of CMS’ decision on the informal review request much earlier than we would haveCMS-1612-FC 838

been able to do with the previous informal review request deadline we can provide a brief period for an eligible or group practice to make some limited correcti ons to its PQRS data. Th is resubmitted data could

then be used to make corrections to the VM calculations, when appropriate. The PQRS regulations at §414.90(m)(1) currently require an eligible professional or group practice to submit an informal review request to CM S within 90 days of the release of the feedback reports. Therefore, we proposed to revise §414.90(m)(1 ) to require the request of the informal review within 30 days of release of the feedback reports. Regarding the eligible professional’s or group pr actice’s ability to provide additional information to assist in the informal review process, we propo sed to provide the following limitations as to what information might be taken into consideration:

● CMS would only allow resubmission of data that was submitted using a third-party vendor using the qualified registry, EHR data submission vendor, or QCDR reporting mechanisms. Therefore,

CMS would not allow resubmission of data submitted via claims, direct EHR, or the GPRO web interface reporting mechanisms. We are limiting resubmission to third-party vendors, because we believe that third-party vendors are more easily able to detect errors than direct users.

● CMS would only allow resubmission of data th at was already previously submitted to CMS.

Submission of new data – such as new measures data not previously submitted or new data for eligible professionals for which data was not submitted durin g the original submission period – would not be accepted.

● For any given resubmissi on period, CMS would only accept data that was previously submitted for the reporting periods for which the corr esponding informal review period applies. For example, the resubmission period immediately following the informal review period for the 2017 PQRS payment adjustment would only allow resubmission fo r data previously submitted for the 2017 PQRS payment adjustment reporting periods occurring in 2015. As such, we proposed to add §414.90(m)(3) to reflect this proposal as follows: (3) If, during the informal review process, CMS finds errors in data that was submitted using a third-party vendor using either the qualified registry, EHR data submissi on vendor, or QCDR reporting mechanisms, CMS mayCMS-1612-FC 839

allow for the resubmission of data to correct these e rrors. (i) CMS will not allow resubmission of data submitted via claims, direct EHR, and the GPRO we b interface reporting mechanisms. (ii) CMS will only allow resubmission of data that was already previously submitted to CMS. (iii) CMS will only accept data that was previously submitted for the repo rting periods for which the corresponding informal review period applies. We invited public comment on these proposals. The following is summary of the comments we received regarding on these proposals. Comment: Several commenters opposed our proposal to change the amount of time an eligible professional or group practice would have to submit an informal review request to 30 days. One commenter stated that it was necessary to have a longer timeframe, as accessing PQRS feedback reports can be extremely cumbersome and time-intensive. The commenters believed that 30 days was an insufficient amount of time to access, analyze, and iden tify errors in the PQRS feedback reports. Some of these commenters urged CMS to extend the request period to 60 or 90 days in lieu of 30 days. Response: We understand that this provides e ligible professionals and group practices with a

much shorter timeline with which to submit an in formal review request. We also understand the commenters’ concerns regarding having to access a nd analyze the feedback reports as well as submitting an informal review request within 30 days. As we stated in the proposed rule, it is necessary to shorten

the timeline in order to be allow for the resubmission of data, if applicable to the eligible professional or group practice. However, given these concerns, we will increase the amount of time in which eligible professionals and group practices may submit an inform al review request. In order to finalize our proposal to allow for the resubmission of data, it is necessary to receive all informal review requests within 60 days of the release of the feedback reports . At this time, we believe the 60-day deadline still provides us with enough time to allow for the resubmi ssion of data. However, should we find that more time is needed to process resubmissions, we reserve th e right to propose further changes to this deadline in future rulemaking. Therefore, for the reasons stat ed above and in the proposed rule, we are finalizing our proposal to modify §414.90(m)(1) to indicate th e payment adjustment informal review deadline to within 60 days of the release of the feedback reports beginning in 2015.CMS-1612-FC 840

Comment: Several commenters generally supported our proposal to allow for resubmission of

data. Response: We appreciate the commenters’ suppor t for this proposal. Based on the support for this proposal and for the reasons we stated in the pr oposed rule, we are finalizing our proposal to allow for resubmission of data as proposed. As we propo sed, we are providing the following limitations as to what information might be taken into consideration:

● CMS would only allow resubmission of data th at was submitted by a third-party vendor on behalf of an eligible professional or group practi ce using the qualified registry, EHR data submission vendor, or QCDR reporting mechanisms. Therefor e, CMS would not allow resubmission of data submitted via claims, direct EHR, or the GPRO we b interface reporting mechanisms. We are limiting resubmission to third-party vendors, because we believe that third-party vendors are more easily able to

detect errors than direct users.

● CMS would only allow resubmission of data th at was already previously submitted to CMS.

Submission of new data – such as new measures data not previously submitted or new data for eligible professionals for which data was not submitted durin g the original submission period – would not be accepted.

● For any given resubmissi on period, CMS would only accept data that was previously submitted for the reporting periods for which the corr esponding informal review period applies. For example, the resubmission period immediately following the informal review period for the 2017 PQRS payment adjustment would only allow resubmission fo r data previously submitted for the 2017 PQRS payment adjustment reporting periods occurring in 2015.

Because of the comments received and for the reasons stated above and in the proposed rule, we are finalizing our proposal to modify the payment adju stment informal review deadline to within 60 days of the release of the feedback reports. In addition, to allow resubmission of data, we are finalizing our proposal, as proposed, to add §414.90(m)(3) as follows: (3) If, during the informal review process, CMS finds errors in data that was submitted using a thir d-party vendor using either the qualified registry, EHR data submission vendor, or QCDR reporting mechanisms , CMS may allow for the resubmission of data toCMS-1612-FC 841

correct these errors. (i) CMS will not allow resubmi ssion of data submitted via claims, direct EHR, and the GPRO web interface reporting mech anisms. (ii) CMS will only allow resubmission of data that was already previously submitted to CMS. (iii) CMS w ill only accept data that was previously submitted for the reporting periods for which the correspondi ng informal review period applies. L. Electronic Health Record (EHR) Incentive Program The HITECH Act (Title IV of Division B of the ARRA, together with Title XIII of Division A of the ARRA) authorizes incentive payments under Medicare and Medicaid for the adoption and meaningful use of certified EHR technology (CEHRT ). Section 1848(o)(2)(B)(iii) of the Act requires that in selecting CQMs for e ligible professionals (EPs ) to report under the EHR Incentive Program, and in establishing the form and manne r of reporting, the Secretary

shall seek to avoid redundant or duplicative re porting otherwis e required. As such, we have taken steps to establish alignments among variou s quality reporting and payment programs that include the submission of CQMs. For CY 2012 and subsequent year s, §495.8(a)(2)(ii) requires an EP to successfully report the clinical quality measures selected by CMS to CMS or the states, as applicable, in the form and manner specified by CMS or th e states, as applicable.

In the CY 2014 PFS final rule with comment period (78 FR 74756), we finalized our proposal to require EPs who seek to report CQMs electronically under the Medicare EHR Incentive Program to use the most recent versio n of the electronic spec ifications for the CQMs

and have CEHRT that is tested and certified to the most recent version of the electronic specifications for the CQMs. We noted it is impor tant for EPs to electronically report the most

recent versions of the electro nic specifications for the CQMs as updated measure versions correct minor inaccuracies found in prior measure versions. We stated that to ensure that CEHRT products can successfully transmit CQM da ta using the most recent version of theCMS-1612-FC 842

electronic specifications for the CQ Ms, it is important that the produc t be tested and certified to

the most recent version of the elec tronic specifications for the CQMs. Since finalizing this proposal, we have received feedback from stakeholders regarding the difficulty and expense of having to test and recertify CEHRT products to the most recent version of the electronic specif ications for the CQMs. Although we still believe EPs should test and certify their products to the most recent versi on of the electronic spec ifications for the CQMs when feasible, we understand the burdens associat ed with this requirement. Therefore, to eliminate this added burden, we proposed that, beginning in CY 2015, EPs would not be required to ensure that their CEHRT produc ts are recertified to the most re cent version of the electronic specifications for the CQMs. Please note that, a lthough we are not requiri ng recertification, EPs must still report the most rece nt version of the electronic specifications for the CQMs. In the CY 2014 PFS final rule with comment pe riod, we established the requirement that EPs who seek to report CQMs electronically unde r the Medicare EHR In centive Program must

use the most recent version of the electronic specifications for the CQMs (78 FR 74756). We solicited and received the following public comments on these proposals: Comment: The majority of commenters suppo rted our proposal not to require EPs to recertify their EHR products to the most recent version of the eCQMs. One commenter opposed this proposal, stating that if we did not require recertification so me products run the risk of not being able to perform critical Stage 2 functions such as secure messaging between patients and providers, offering patients the ability to vi ew, download, and transmit their own health information, and improving care transitions with a summary of care record for transitions and

referrals. Response: We appreciate the commenters’ supp ort for this proposal. With respect to the commenter who opposed this proposal, we agree that it is important to recer tify as frequently asCMS-1612-FC 843

possible for the reasons the commenter stated. However, at this time, we understand that requiring recertification to the most recent version of the electroni c specifications for the CQMs, which could occur annually, may be overly burdensome and time-consuming for providers. Please note that this proposal wa s limited to EPs and not intended to apply to eligible hospitals (EHs) or critical access hospitals. Based on the comments received and for the reasons stated in the proposed rule, we are finalizing our propos al that, beginning in CY 2015, EPs are not required to ensure that their CEHRT products are recertified to the most recent version of the electronic specifications for the CQMs. Although we are not requ iring recertification, EPs must still report the most recent version of th e electronic specifica tions for the CQMs. Additionally, we noted in the proposed rule that, with respect to the following measure CMS140v2, Breast Cancer Hormonal Therapy for Stage IC–IIIC Estrogen Receptor/Progesterone Receptor (ER/PR) Positi ve Breast Cancer (NQF 0387), a substantive

error was discovered in the June 2013 version of this electronically specified clinical quality measure (79 FR 40474). If an EP chooses to re port this measure elect ronically under the EHR Incentive Program in CY 2014, the prior, Decem ber 2012 version of the measure, which is CMS140v1, must be used (78 FR 74757). In the proposed rule (79 FR 40474), we stated that because a more recent and corrected version of this measure has been developed, we will require the reporting of the most rece nt, updated version of the meas ure Breast Cancer Hormonal Therapy for Stage IC–IIIC Estrogen Receptor/Pr ogesterone Receptor (ER/PR) Positive Breast Cancer (NQF 0387), if an EP chooses to repo rt the measure electro nically in CY 2015. In the EHR Incentive Program Stage 2 final rule, we established CQM reporting options

for the Medicare EHR Incentive Pr ogram for CY 2014 and subseque nt years that include one individual reporting option that aligns with the PQRS’s EHR reporting option (77 FR 54058) and two group reporting options that align with the PQRS GPRO a nd Medicare Shared SavingsCMS-1612-FC 844

Program (MSSP) and Pioneer ACOs (77 FR 54076 to 54078). In the CY 2014 PFS final rule with comment period, we finalized two additiona l aligned options for EPs to report CQMs for the Medicare EHR Incentive Program for CY 2014 a nd subsequent years with the intention of minimizing the reporting burden on EPs (78 FR 74753 through 74757). One of the aligned options finalized in the CY 2014 PFS final rule with comment period (78 FR 74754 through 74755) is a reporting option for CQMs for the Me dicare EHR Incentive Program under which EPs can submit CQM information using qualified clin ical data registries, according the definition and requirements for qualifie d clinical data registries established under the PQRS. The second aligned option finalized in the CY 2014 PFS final rule with comment period (78 FR 74755 through 74756) is a group reporti ng option for CQMs for the Medicare EHR Incentive Program beginning in CY 2014 under wh ich EPs who are part of a Comprehensive Primary Care (CPC) initiative practice site that successfully reports at le ast nine electronically specified CQMs across three domains for the rele vant reporting period in accordance with the requirements established for the CPC initiati ve and using CEHRT w ould satisfy the CQM reporting component of meaningf ul use for the Medicare EHR Incentive Program. If a CPC practice site is not suc cessful in reporting, EPs who are part of the site would still have the opportunity to report CQMs in acco rdance with the requirements es tablished for the Medicare EHR Incentive Program in the Stage 2 final ru le. Additionally, only those EPs who are beyond their first year of demonstrating meaningful use may use this CPC group reporting option. The CPC practice sites must submit the CQM data in the form and manner required by the CPC initiative. Therefore, whether CPC required el ectronic submission or attestation of CQMs, the CPC practice site must submit the CQM data in the form and manner required by the CPC

initiative.CMS-1612-FC 845

The CPC initiative, under the authority of sec tion 3021 of the Affordable Care Act, is a multi-payer initiative fostering collaboration be tween public and private health care payers to strengthen primary care. Under this initiative, we will pay participating primary care practices a care management fee to support enhanced, coordi nated services. Simulta neously, participating commercial, state, and other federal insuran ce plans are also offering enhanced support to primary care practices that prov ide high-quality primary care. There are approximately 483 CPC practice sites across 7 health care markets in th e U.S. More details on the CPC initiative can be

found at http://innovation.cms.gov/initiatives /Comprehensive-Primary-CareInitiative/index.html

. Under the CPC initiative, CPC practice sites are required to report to CMS a subset of the CQMs that were selected in the EHR Incentive Program Stage 2 final rule for EPs to report under the EHR Incentive Program beginning in CY 2014 (for a list of CQMs that were selected in the EHR Incentive Program Stage 2 final ru le for EPs to report under the EHR Incentive Program beginning in CY 2014, see 77 FR 54069 th rough 54075). We proposed to retain the group reporting option for CPC prac tice sites as finalized in th e CY 2014 PFS final rule, but to relax the requirement for the CQMs to cover thre e domains. Instead, we proposed that, for CY 2015 only, under this group reporting option, the CPC practice site must report a minimum of nine CQMs from the CPC subset, and the nine CQMs reported must cover at least 2 domains, although we strongly encouraged practice si tes to report across more domains if feasible. Although the requirement to report acr oss three domains is important because the

domains are linked to the Nati onal Quality Strategy and used throughout CMS quality programs, the CPC practice sites are require d to report from a limited number of CQMs that were selected for the EHR Incentive Program and are focused on a primary care population. Therefore, these CPC practice sites may not have measures to select from that cover three domains. Additionally,CMS-1612-FC 846

CPC practice sites are assessed for quality perf ormance on measures othe r than electronically specified CQMs which do cover other National Qu ality Strategy domains. We invited public comment on this proposal. The following is a summary of the comments we received regarding our proposal on the group reporting option for CPC practice sites.

Comment: A few commenters indicated general support for relaxing the domain requirement for the primary care physicians, indi cating providers should be able to select the measures most applicable to their population. Response: We appreciate the support for this proposal. The CP C CQM set targets a primary care patient population and therefore is appropriate for reporti ng by CPC practice sites

in the model. Comment: One commenter opposed relaxi ng the reporting requirements for CPC practice sites to only report 2 domains instead of 3. The commenter indicated consumers and purchasers want to see measures across these do mains reported electron ically. The commenter believed CPC practice sites have sufficient measures to choose from to report 9 measures that

cover 3 domains. Response: The CPC initiative is a model tested by the Center for Medicare and Medicaid Innovation. As such, CPC includes specific quali ty measure reporting requirements for each CPC practice site to be eligible to participat e in any Medicare shared savings, which is a component of the model. The quality reporting re quirements include repor ting on a subset of the CQMs selected for the EHR Incentiv e Program beginning in CY 2014.

The CPC measure subset includes a total of 11 measures, of which 7 fall in the clinical process/effectiveness domain, 3 in the population h ealth domain, and 1 in the safety domain. We proposed to reduce the number of domains required to at least 2 domains to allow CPC practiceCMS-1612-FC 847

sites that would be unable to obtain in their EH R the one safety CQM in the CPC measure subset to meet the MU CQM requirement. This woul d provide CPC practice sites an opportunity to successfully report to the CPC model and satisfy the CQM repor ting component of meaningful use, so they would not have to report quality measures twice to both CPC and the Medicare EHR Incentive Program.

After consideration of the comm ents received, and for the reasons stated previously, we are finalizing the proposal to redu ce the required number of doma ins for CY 2015 only as proposed.CMS-1612-FC 848

M. Medicare Shared Savings Program Under section 1899 of the Act, CMS has es tablished the Medicare Shared Savings program (Shared Savings Program) to facilitate coordination and cooperation among providers to improve the quality of care for Medicare Fee-For- Service (FFS) beneficiaries and reduce the rate of growth in health care costs. Eligible groups of providers and suppliers, including physicians, hospitals, and other health care providers, may participate in the Shared Savings Program by forming or participating in an Accountable Care Organization (ACO). The final rule implementing the Shared Savings Program appeared in the November 2, 2011 Federal Register (Medicare Shared Savings Program: Accountable Care Organizations Final Rule (76 FR 67802)). Section 1899(b)(3)(A) of the Act requires the Secretary to determine appropriate measures to assess the quality of care furnished by ACOs, such as measures of clinical processes and outcomes; patient, and, wherever practicable , caregiver experience of care; and utilization such as rates of hospital admission for ambulator y sensitive conditions. Section 1899(b)(3)(B) of the Act requires ACOs to submit data in a form and manner specified by the Secretary on measures that the Secretary determines necessary for ACOs to report to evaluate the quality of care furnished by ACOs. Section 1899(b)(3)(C) of the Act requires the Secretary to establish quality performance standards to assess the qual ity of care furnished by ACOs, and to seek to improve the quality of care furnished by ACOs over time by specifying higher standards, new measures, or both for the purposes of assessi ng the quality of care. Additionally, section 1899(b)(3)(D) of the Act gives th e Secretary authority to incor porate reporting requirements and incentive payments related to the PQRS, EHR Incentive Program and other similar initiatives under section 1848 of the Act. Finally, section 1 899(d)(1)(A) of the Act states that an ACO isCMS-1612-FC 849

eligible to receive payment for shared savings, if they are ge nerated, only after meeting the quality performance standards established by th e Secretary. In the November 2011 final rule establishing the Shared Savings Program, we established the quality performance standards th at ACOs must meet to be eligib le to share in savings that are generated (76 FR 67870 through 67904). Quality performance measures are submitted by ACOs through a CMS web interface, currently the gr oup practice reporting option (GPRO) web interface, calculated by CMS from internal and claims data, and collected through a patient and caregiver experience of care survey.

Consistent with the directiv e under section 1899(b)(3)(C) of the Act, we believe the existing Shared Savings Program regulations in corporate a built in mechanism for encouraging ACOs to improve care over the course of thei r 3-year agreement period, and to reward quality improvement over time. During the first year of the agreement period, ACOs can qualify for the maximum sharing rate by completely and accurate ly reporting all quality measures. After that, ACOs must meet certain thresholds of perfor mance, which are currently phased in over the course of the ACO’s first agreement period, a nd are rewarded for improved performance on a sliding scale in which higher levels of quality pe rformance translate to higher rates of shared savings (or, for ACOs subject to performance-based risk that de monstrate losses, lower rates of shared losses). In this way, th e quality performance standard in creases over the course of the ACO’s agreement period. Additionally, we have made an effort to align quality performance measures, submission methods, and incentives under the Shared Savi ngs Program with the PQRS. Eligible professionals participating in an ACO may qua lify for the PQRS incentive payment under theCMS-1612-FC 850

Shared Savings Program or avoid the downwar d PQRS payment adjustment when the ACO satisfactorily reports the ACO GPRO measures on their behalf using th e GPRO web interface.

Since the November 2011 final rule establishi ng the Shared Savings Program was issued,

we have revisited certain as pects of the quality performan ce standard in the annual PFS rulemaking out of a desire to ensure thoughtfu l alignment with the ag ency’s other quality incentive programs that are addressed in that ru le. Specifically, we have updated our rules to align with PQRS and the EHR Incentive Program, and addressed issues related to benchmarking and scoring ACO quality performance ( 77 FR 69301 through 69304; 78 FR 74757 through 74764). This year, as part of the CY 2015 Phys ician Fee Schedule proposed rule, we addressed several issues related to the Shared Savings Program quality performance standard and alignment with other CMS quality initiatives . Specifically, we revisited th e current quality performance standard, proposed changes to the quality meas ures, and sought comment on future quality performance measures. We also proposed to modify the timeframe between updates to the quality performance benchmarks, to establish an additional incentive to reward ACO quality improvement, and to make several technical correc tions to the regulations in subpart F of Part

425. 1. Existing Quality Measures and Performance Standard As discussed previously, s ection1899(b)(3)(C) of the Act st ates that the Secretary may establish quality performance standards to assess the quality of care furnished by ACOs and “seek to improve the quality of care furnished by ACOs over time by specifying higher standards, new measures, or both....” In the No vember 2011 Shared Savings Program final rule, we established a quality performance standard that consists of 33 measures. These measures are submitted by the ACO through the GPRO web interf ace, calculated by CMS from administrativeCMS-1612-FC 851

and claims data, and collected via a patient expe rience of care survey ba sed on the Clinician and Group Consumer Assessment of Healthcare Providers and Sy stems (CG-CAHPS) survey. Although the patient experience of care survey used for the Shared Savings Program includes the core CG-CAHPS modules, this patient experience of care survey also includes some additional modules. Therefore, we will refer to the patient experience of care survey that is used under the Shared Savings Program as CAHPS for ACOs. The measures span four domains, including patient experience of care, car e coordination/patient safety, pr eventive health, and at-risk population. The measures collected through the GP RO web interface are also used to determine whether eligible professionals participati ng in an ACO qualify for the 2013 and 2014 PQRS incentive payment or avoid the PQRS payment adjustment for 2015 and subsequent years. Eligible professionals in an ACO may qualify for the PQRS incentive payment or avoid the downward PQRS payment adjustment when the ACO satisfactorily reports all of the ACO

GPRO measures on their behalf using the GPRO web interface. In selecting the 33 measure set, we balanced a wide variety of important considerations. Given that many ACOs were expected to be ne wly formed organizations, in the November 2011 Shared Savings Program final rule (76 FR 67886) , we concluded that ACO quality measures should focus on discrete processes and shor t-term measurable outcomes derived from

administrative claims and limited medical reco rd review facilitate d by a CMS-provided web

interface to lessen the burden of reporting. Because of the focus on Medicare FFS beneficiaries, our measure selection emphasized prevention and management of chronic diseases that have high impact on these beneficiaries such as heart disease, diabetes mellitus, and chronic obstructive pulmonary disease. We believed that the quality measures used in the Shared Savings Program should be tested, evidence-bas ed, target conditions of high cost and highCMS-1612-FC 852

prevalence in the Medicare FFS population, reflec t priorities of the Na tional Quality Strategy,

address the continuum of care to reflect the requirement that ACOs accept accountability for their patient populations, and align with existi ng quality programs and value-based purchasing

initiatives. At this time, we continue to believe it is most appropriate to focus on quality measures that directly assess the overall quality of care furnished to FFS beneficiaries. The set of 33 measures that we adopted in the November 2011 Shared Savings Program final rule includes measures addressing patient experience, outcomes, and evidence-based care processes. Thus far, we have not included any specific measures addressing high cost serv ices or utiliz ation since we believe that the potential to earn shared savings offers an impo rtant and direct incentive for ACOs to address utilization issues in a way that is most appropriate for their organization, patient population, and local healthcare environment. We note that while the quality performance standard is limited to these 33 measures, the performance of ACOs is measured on many more metrics and ACOs are informed of their performa nce in these areas. For example, an assessment

of an ACO’s utilization of certa in resources is provided to th e ACO via quarterly reports that

contain information such as the utilization of em ergency services or the utilization of CTs and

MRIs. As we have stated previously (76 FR 67872), our principal goal in selecting quality measures for ACOs was to identify measures of success in the delivery of high-quality health care at the individual and population levels. We believe endorsed measures have been tested, validated, and clinically accepted, and therefore, selected the 33 measures with a preference for NQF-endorsed measures. However, the statute does not limit us to using endorsed measures in the Shared Savings Program. As a result we al so exercised our discre tion to include certainCMS-1612-FC 853

measures that we believe to be high impact but that are not currently endorsed, for example, ACO#11, Percent of PCPs Who Successfully Qua lify for an EHR Incentive Program Payment. In selecting the final set of 33 measures, we sought to in clude both process and outcome measures, including patient experience of care (7 6 FR 67873). Because ACOs are charged with improving and coordinating care and delivering high quality care, but also need time to form, acquire infrastructure and develop clinical care processes, we continue to believe it is important to have a combination of both process and outcome s measures. We note, however, that as other CMS quality reporting programs, such as PQRS, move to more outcomes-based measures and fewer process measures over time, we may also re vise the quality performance standard for the Shared Savings Program to incorporate mo re outcomes-based measures over time. Therefore, we viewed the 33 measures a dopted in the November 2011 Shared Savings Program final rule as a starting poi nt for ACO quality measurement. As we stated in that rule (67 FR 67891), we plan to modify the measures in future reporting cycles to reflect changes in practice and improvements in qua lity of care and to continue aligning with other quality reporting programs and will add and/or retire m easures as appropriate through the rulemaking process. In addition, we are working with the measures community to ensure that the specifications for the measures used under the Sh ared Savings Program ar e up-to-date. We note that we must balance the timing of the release of specifications so they are as up-to-date as possible, while also giving ACOs sufficient time to review specifications. Our intention is to issue the specifications annually, prior to the start of the reporting period for which they will apply. In the November 2011 Shared Savings Program final rule (76 FR 67873), we combined care coordination and patient safety into a single domain to better align with the National QualityCMS-1612-FC 854

Strategy and to emphasize the importance of ambu latory patient safety and care coordination. We also intended to continue exploring ways to best capture ACO care coordination metrics and noted that we would consider adding new care coordination measures fo r future years (67 FR 67877). 2. Changes to the Quality Measures Used in Establishing Quality Performance Standards that ACOs must meet to be Eligible for Shared Savings a. Background and Proposal. Since the November 2011 Shared Savings Pr ogram final rule, we have continued to review the quality measures used for the Shared Savings Program to ensure that they are up to date with current clinical pract ice and are aligned with the GP RO web interface reporting for PQRS. Based on these reviews, in the CY 2015 Physician F ee Schedule proposed rule, we proposed a number of measure additions, deletions and other revisions that we believed would be appropriate for the Shared Savings Program. An overview of changes we proposed is provided in Table 50 of the proposed rule (79 FR 40479 th rough 40481) which lists the measures that we proposed would be used to assess ACO quality under the Shared Savings Program starting in 2015. To summarize, we proposed to add 12 new m easures and retire eight measures. We also proposed to rename the EHR measure in order to reflect the transition from an incentive payment to a payment adjustment under the EHR Incentive Program and to revise the component measures within the Diabetes and CAD composites. In total, we proposed to use 37 measures for establishing the quality performance standard that ACOs must meet to be eligible for shared savings. Although the total number of measures w ould increase from the current 33 measures to 37 measures under this proposal, we stated we did not anticipate that this would increase the reporting burden on ACOs because the increased number of measures is accounted for byCMS-1612-FC 855

measures that would be calculated by CMS using administrative claims data or from a patient survey. The total number of measures that th e ACO would need to directly report through the CMS website interface would actually decrease by one, in addition to removing redundancy in measures reported. Finally, as part of the proposed changes, we proposed to replace the current five component diabetes composite meas ure with a new four component diabetes composite measure. In addition, we proposed to replace the current tw o component coronary artery disease composite measure with a new four component coronary ar tery disease composite measure. Under this proposal, 21 measures would be reported by AC Os through the GPRO web interface and scored

as 15 measures. Below, we summarize and group comment s received on these proposals by first responding to general comments on our proposals and then by the method of data submission for the measure as listed in Table 50 of the pr oposed rule (79 FR 40479 through 40481) (that is, survey, claims, EHR incentive prog ram, and the CMS web interface). In order to align the measures submitted through the CMS web interf ace with the PQRS and VM programs, we discuss specific comments in response to the proposed changes to the measures submitted through the CMS web interface with the comments received for these same measures for the PQRS and the VM programs. See Tables 79 and 80 in section III.K., for a discussion of and response to these comments.

General Comment: In addition to the comments that focus on individual measures, we received many general comments about the quality performance measures used in the Shared Savings Program. For example, we received many comments supporting the alignment between ACO, PQRS and VM quality measures and an increased focus on outcomes-based qualityCMS-1612-FC 856

measures. Some commenters objected to th e net increase in measures, believing there is underlying burden for providers even for claims-based measures. Additionally, many ACOs did not support the proposed new measures, suggestin g, for example, they would be unnecessary because of the incentives inherent to the Shared Savings Program, or that, in general, the new proposed measures are inadequate ly defined, tested or benchmar ked. These ACOs believed that many of the proposed new measures address c linical issues beyond an ACO’s control and

therefore should not be added. Other concerns about the new m easures were that they would require substantial change in cl inical practice, would substantia lly add to the reporting burden, and/or are questionably relate d to improving care quality and/or patient outcomes. Other commenters supported adding the new measures. One commenter, for example, stated that “the expanded measures are important utilization and manageme nt measures that our developing ACO would have likely considered and built into our ACO Cost, Utilization, and Risk dashboard anyway. From a clinical a nd system standpoint, these additions are key components of better managing avoidable utilizati on and costs. They are measures we would want to know regardless of the Proposed Rule.” MedPAC suggested th at CMS move quality measurement for ACOs, MA plans, and FFS Medi care in the direction of a small set of population-based outcome measures, such as potentially preventable inpatient hospital admissions, emergency department visits, and readmissions. Response: We continue to believe it is a ppropriate to add, remove, and modify quality measures for the Shared Savings Program to refl ect changes in clinical practice and for other program needs. We want to minimize any addi tional burdens this could create for ACOs and their ACO participants and ACO pr oviders/suppliers. Therefore, we agree with the comments in support of the alignment between ACO, PQRS and VM for the quality measures submittedCMS-1612-FC 857

through the CMS web interface, and an increased focus on outcomes-based quality measures. We disagree with those ACOs that suggest ed certain proposed ne w measures would be unnecessary because of the incentives inherent to the Shared Savings Program. Instead, we agree with the commenter who noted that such measures can be important utilization and management tools that many ACOs may consider and build into their own internal monitoring systems as a way to help manage avoidable utiliz ation and costs. Furthe r, we believe certain proposed new measures highlight the value of discussions with patients about their care. b. Survey based measure:

● CAHPS Stewardship of Patient Resources . This measure is one of the unscored survey measures currently collected in addition to the seven scored survey measures that are already part of the current set of 33 measures under the Shared Savings Program. Information on the unscored survey measure modules is currently shared with the ACOs for informational purposes only. The Stewardship of Patient Resour ces measure asks the patient whether the care team talked with the patient about prescription medicine cost s. The measure exhibited high reliability during the first two administrations of the CAHPS survey, and during testing, the beneficiaries that participated in cognitive testing said that prescription drug costs were important to them. We proposed to add Stewardshi p of Patient Resources as a scored measure in the patient experience domain because we believe, based on testing, that this is an important factor for measuring a beneficiar y’s engagement and experience with healthcare providers. We also proposed that the measure w ould be phased into pay for performance as we plan to do for other new measures, using a similar process to the phase in that was used for the scored measure modules in the survey that are currently us ed to assess ACO quality performance.

Comment: Some comment ers supported the proposed addi tion of this measure, agreeingCMS-1612-FC 858

that discussing the cost of medications is importa nt to assess the possibility that medication costs may be a barrier to care or that the measure may be an indicator of a pa tient’s satisfaction with

the care he or she is receivi ng. Other commenters questioned how this discussion leads to a plan of action or a modified plan of treatment to improve care if the pa tient is unable to pay for the

medication. These commenters asked us to fu rther explain how we envision this measure improving patient care. Some be lieve it would be reasonable to include this measure under pay for reporting, but that additional discussions with the community would be needed in order to establish an appropriate benchmark for this measure, as this is a relative ly new measure. Some thought that physician discussions with patients regarding medicat ion cost would be appropriate for “high tier,” costly medications, but would be of questionable valu e relative to measuring patient-centered, quality care delivery for more frequently prescribed, lower cost, generic

medications and/or the extent to which patients take medications as prescribed. Some commenters suggested that it woul d be unnecessary and/or burdensome to add this measure. For example, commenters indicated that physicians do not and cannot know the co-pays for each drug under each insurance plan and product a nd that there would be tremendous patient dissatisfaction when inaccurate pricing or cost information is provided to the patient by the provider. Some commenters believe this measur e is unnecessary since encouraging adherence to medications is a key strategy for ACOs to reduc e avoidable costs, and inability to afford medications is a key barrier to a dherence, so ACOs already have an incentive to discuss the cost of medications with their patients. Response: This measure asks patients whet her any health care pr ovider spoke to them about their prescription medication costs and does not require that physi cians know the co-pays for each drug under each insurance plan and produc t. Additionally, discussing this topic withCMS-1612-FC 859

beneficiaries can lead a clinic ian to understand whether and ho w the beneficiary may struggle with payment for medications, a factor that can a ffect adherence to prescribed regimens. We can therefore envision a scenario where, once the issu e is identified, a clinician participating in an ACO could inform and educate the beneficiary a bout less expensive options , such as the use of generic medications, or about available commun ity resources, as part of the ACO’s care coordination processes required under §425.112(b)(4). This in turn could directly improve the quality of care the beneficiary receives by improving medication adherence and leading to greater beneficiary engagement. Because this m easure is already part of the CAHPS survey, we do not believe it will increase reporting burden fo r the ACO. The CAHPS survey question is available in the CAHPS Survey for ACOs Qu ality Assurance Guidelines on the CAHPS for ACOs website. As discussed below, because this is a new measure, the measure will be pay-forreporting for the first two reporting periods it is in use for all AC Os, regardless of the phase-in schedule to pay-for-performance, in order to prov ide time for the development of an appropriate

benchmark. Final Decision: We are finalizing our propos ed addition of the C AHPS: Stewardship of

Patient Resources measure. After the measur e has been used in the program under pay for reporting for two reporting periods, it will be pay-for-reporting for the first performance year of an ACO’s first agreement period and pay-for-performance for the ACO’s second and third performance years. We continue to believe th at it is important for phys icians and others to discuss the beneficiary’s perspec tive on the cost of medications because is important to assess the possibility that medication co sts may be a barrier to care. The measure exhibited high reliability during the first two administrations of the CAHPS survey, and during testing, theCMS-1612-FC 860

beneficiaries that participated in cognitive testing said that prescription drug costs were important to them. c. Claims Based Measures to be Computed by CMS

● Skilled Nursing Facility 30-Day All-Ca use Readmission Measure (SNFRM). We proposed to add a 30-day all cause skilled nursing facility (SNF) readmission measure. CMS is

the measure steward for this claims-based meas ure, which is under review at NQF under NQF

#2510. This measure estimates the risk-standar dized rate of all-cau se, unplanned, hospital readmissions for patients who have been admitted to a SNF within 30 days of discharge from a prior inpatient admission to a hospital, CAH, or a psychiatric hospital. The measure is based on

data for 12 months of SNF admissions. We beli eve this measure would help fill a gap in the current Shared Savings Program measure set an d would provide a focus on an area where ACOs are targeting care redesign. ACOs and their ACO participants often include post-acute care (PAC) settings and the addition of this measure would enhance the participation of and alignment with these facilities. Even when the ACO does not include post-acute facilities formally as part of its organi zation, ACO providers/suppliers furnis h other services that have the potential to affect PAC outco mes. Thus, this measure would emphasize the importance of coordinating the care of beneficiaries across th ese sites of care. Additionally, because this measure would be calculated from claims, there would not be a burden on ACOs to collect this

information. Comment: A number of commenters supported including the measure and/or the concept to align the incentives of ACOs and SNFs to lower their readmission rates. Some provided suggestions to further refine the measure, such as to use a risk-adjuste d measure of potentially avoidable readmissions for SNFs. Although MedP AC recommended that CMS consider a risk-CMS-1612-FC 861

adjusted, potentially avoidable readmission measur e for SNFs, they did support the addition of a SNF readmission measure because of the importa nce of post-acute care management and care transitions between settings in improving benefi ciary care. Another commenter supported the measure but encouraged delay until such time as Medicare readmission policy links a portion of SNF payments to their readmission rates so that SN Fs would bear risk/penalty equal to that of other providers in order to in cent readmissions reduction. Some commenters believe that it is unnecessary and duplicative to add th is quality measure since it is an inherent part of the Shared Savings Program that an ACO will be penalized th rough a reduction in shared savings if it has a high rate of readmissions. They also argue that ACOs that us e SNFs for higher-acuity patients

could see an increase in SNF readmission rate s and thus be inappropriately penalized. A commenter suggested ACO scores will be inappropria tely affected when beneficiaries return to an ACO participant hospital after be ing discharged to a SNF that is not participating in the ACO. In such cases, an ACO may be unable to achieve th e same level of collaboration needed to affect change as compared to ACOs that include one or more SNFs as AC O participants or ACO providers/suppliers. Concern was also expressed regarding the ability of ACOs to consistently monitor psychiatric hospital discharges since federal laws limit the us e and disclosure of documentation regarding drug and substance abuse as well as mental health therapies. These commenters recommend removing psychiatric ho spital admissions from this measure since ACOs currently do not receive mental health clai ms data and should not be held accountable for measures for which they are not able to collect and monitor data over the performance period. Operational concerns were also raised includi ng data lags and that ACOs can only derive raw admissions/readmission rates from the monthly claims files and the commenters believe these rates are not useful for impr oving performance against benchmarks unless CMS provides theCMS-1612-FC 862

algorithm to apply the appropriate risk adjustment. These commenters indicate that ACOs face significant challenges in monitori ng performance when reliable ri sk-adjusted rates of admissions and readmissions are not provi ded on a regular basis. Response: We appreciate the numerous t houghtful comments. We disagree with commenters that this measure is unnecessary and dup licative because we continue to believe that including this measure would reinforce the impor tance of coordinating the care of beneficiaries across hospital and SNF sites of care. We have previously expressed our expectation that ACOs

coordinate the care of beneficiaries across thes e sites regardless of whether there are any postacute care (PAC) providers pa rticipating in the ACO (§425.112( b)(4)). Even when the ACO does not include post-acute facilities formally as ACO participants or ACO providers/suppliers, ACO providers/suppliers furnish othe r services that have the potent ial to affect PAC outcomes. Thus, this measure would emphasize the importan ce of coordinating the care of beneficiaries

across these sites of care. Add itionally, because this measure is calculated from claims, there would not be a reporting burden on ACOs to co llect this information. We appreciate the recommendations that we use a risk-adjusted, potentially avoidable SNF readmission measure, however, there is currently no such measure available for use. We note that the SNF 30-day allcause readmission measure does exclude planne d readmissions using a similar methodology to ACO-8 Risk-Standardized, All Condition Readmission. Unplanne d readmission rates do provide

ACOs with useful information to better coordina te care and work toward reducing the risk of readmissions for all patients, in cluding patients coming from a SNF. Further, contrary to the assertion of some commenters, we note that the HIPAA Privacy Rule generally provides the same protections for mental health information as it does for all protected health information (with the exception of psychotherapy notes). See the Department’s guidance on the HIPAACMS-1612-FC 863

Privacy Rule and sharing information re lated to mental health, available at http://www.hhs.gov/ocr/privacy/hipaa/unde rstanding/special/mhguidance.html . Thus, ACOs that request claims data under §425.704 for purposes of th eir own health care operations or the health care operations of their covere d entity ACO participants a nd ACO providers/suppliers, in accordance with HIPAA requirements, already receive information a bout mental health therapies as part of those data sets. Final Decision: We are finalizing our pr oposal to add this 30-day all-cause SNF

readmission measure. After the measure has been used in the program under pay for reporting for two reporting periods, the measure will be pay-for-reporting in the first two performance years of an ACO’s first agreement period and wi ll transition to pay-for-performance in the final year of the ACO’s agreement period. We believe th is measure will help fill a gap in the current Shared Savings Program measure set and will provide a focus on an area where ACOs are targeting care redesign.

● All-Cause Unplanned Admissions for Patie nts with Diabetes Mellitus (DM), Heart Failure (HF) and Multiple Chronic Conditions. We proposed to add three new measures to the Care Coordination/Patient Safety domain. The three new measures are for: all-cause unplanned

Admissions for Patients with Diabetes Mellit us (DM), all-cause unplanned Admissions for Patients with Heart Failure (HF) and all-cause u nplanned Admissions for Patients with Multiple Chronic Conditions (MCC). These three m easures are under development through a CMS

contract with Yale New Haven Health Services Corporation/Center for Outcomes Research and Evaluation (CORE) to develop quality measures sp ecifically for ACO patients with heart failure, diabetes, and multiple chronic conditions. We believe that these measures are important to promote and assess ACO quality as it relates to chronic condition inpatient admission becauseCMS-1612-FC 864

these chronic conditions are major causes for unplanned admissions and the addition of these measures will support the ACOs’ efforts to improve care coordination for these chronic conditions. These measures are claims-based, and therefore, we do not e xpect that they would impose any additional burden on ACOs. The following is a summary of the comments we received regarding our proposal to add

these three new claims-based measures for A ll-Cause Unplanned Admissions for Patients with DM, HF and MCC. Comment: We received a wide variety of comm ents in response to the proposal to add these claims-based measures. Many commenter s supported the use of claims-based outcome measures to reduce reporting burden for providers, however, concerns were raised regarding the lack of NQF endorsement. Some commenters su pported adding one or more of these measures, agreeing that chronic condition inpatient admi ssions are major causes for unplanned admissions

and that the addition of one or more of thes e measures would support the ACOs’ efforts to improve care coordination. For example, a few commenters supported the addition of a measure for All Cause Unplanned Admission for Patients with Multiple Chronic Conditions as all efforts to manage chronic disease may help lead to bett er patient outcomes and control cost. Another commenter supported the measures but preferred collapsing them in to one measure of potentially avoidable hospitalizations, because of concern that the proposed condition-specific measures will be statistically unreliable and s ubject to random variation that will limit their usefulness in distinguishing ACOs’ actual performance. In a ddition, some commenters urged CMS to ensurethe measures are adjusted for planned readmissions, unrelated readmissions and sociodemographic status. Other commenters support ed applying these measures in the Shared Savings Program as pay for repor ting only at this time since these measures are still underCMS-1612-FC 865

development, accepted target rates are not avai lable and the measures are not yet endorsed by NQF. Commenters requested additional definiti on of what “other multiple chronic conditions” would be measured. MedPAC supported an incr ease of outcome meas ures. Finally, some commenters believe it is not possi ble to comment on measures that are still under development, and questioned the added benefit of including th ese measures since ACOs have an inherent

incentive to avoid or redu ce unplanned hospital admissions. Response: We continue to believe that th ese measures are impor tant to promote and assess ACO quality because thes e chronic conditions are majo r causes for unplanned admissions and the addition of these measures will support the ACOs’ efforts to improve care coordination

for beneficiaries with these chronic conditions. These measures are claims-based, and therefore, we do not expect that they would impose any additional reporting burden on ACOs. Many concerns were raised regardi ng the lack of NQF endorsement, but CMS intends on submitting all three measures to NQF for review in the futu re. Draft measure specifications were made available to the public during the measure de velopment comment period during the spring and summer of 2014. CMS will provide final measure specifications to the public when available (typically in the early pa rt of the performance year). The MCC measure cohort definition aligns with the NQF MCC Measurement Framework, wh ich defines patients with MCCs as people “having two or more concurrent chronic conditions that...act together to significantly increase the complexity of management, and affect functi onal roles and health outcomes, compromise life expectancy, or hinder self-management.” 11 The MCC measure cohort of chronic conditions

11 National Quality Forum (NQF). Multiple Chr onic Conditions Measurement Framework. 2012; http://www.qualityforum.org/WorkArea/lin kit.aspx?LinkIdentifier=id&ItemID=71227CMS-1612-FC 866

includes conditions such as, but not limited to, Acute Myocardial Infarction, Stroke, and Chronic Obstructive Pulmonary Disease.

Final Decision: After consider ing the comments received in response to our proposal to add these three measures, we will add the All-Cause Unplanned Admissions for Patients with MCC, HF, and DM measures as pay-for-reporting for two performance years. After this time, the measure will be pay-for-reporting for the firs t two performance years for new ACOs in their first agreement period before transitioning to pay for performance in performance year three. We believe that it is important to include thes e measures in the Shared Savings Program measure set since they were specifically develope d for ACO populations and move the quality performance standard under the Shared Savings Program toward more outcome-based measures. DM, HF, and MCCs affect a large volume of Medi care beneficiaries and can result in high costs due to poorly coordinated care. As a result, these chronic conditions are a focus of many ACO care redesign activities. Finally, these measures are claims-based and therefore do not impose an additional burden on ACOs for data reporting. d. Measure submitted through the EHR incentive program:

● Percent of PCPs who Successfully Meet Meaningful Use Requirements. Because downward adjustments to Medicare payments will begin in 2015 under the EHR Incentive Program, we proposed to modify the na me and specifications for ACO #11 Percent of PCPs who Successfully Qualify for an EHR Incentive Program Payment so that it more accurately depicts successful use and adoption of EHR technology in the coming years. We note this measure would continue to be doubly weighted. Comment: We received a range of comments re garding this proposal. Some agreed that it is necessary to rename the measure given that the EHR Incentive Program begins its transitionCMS-1612-FC 867

to a payment adjustment effective in 2015. Some of the commenters, while agreeing with the proposed change, also provided additional specifica tion suggestions such as to exclude certain physicians, such as hospitalists, from the denominat or of this measure, st ating that hospitalists are not PCPs when providing observation servic es. Another commente r requested that CMS clarify “the interaction of the Medicaid Meaningf ul Use program and the MSSP” and “the impact to non-PCP EPs”. Another commenter requested that CMS make the list of EPs available to ACOs intermittently throughout the performance year to aid ACOs in ensuring that all EPs attest in a timely manner. A commenter questioned w hy this measure in its current form is limited only to PCPs, as opposed to all EPs that are ACO providers/suppliers. Others were concerned that there appeared to be no oppor tunity to exclude phys icians such as thos e who retired, died, moved out the country, from the denominator of th is measure. Finally, th ere were a number of commenters that suggested the measure should be dropped and not renamed, since it is a process

measure and the commenters believe that this meas ure has no direct relati onship to the quality of patient care. Response: We continue to believe, as do a number of commenters, that this is an important measure that should be retained a nd renamed given that downward adjustments to Medicare payments will begin in 2015 under th e EHR Incentive Program. We appreciate the suggestions from commenters that agree with the proposed change and provided additional specification suggestions. We are not persua ded by commenters that suggest this measure should be removed from the quality performance standard for the Shared Savings Program. On the contrary, we believe the measure directly supports the adoption a nd meaningful use of certified EHR technology, which is an important tool to support change in the health care delivery system including the steps being taken by ACOs to improve the quality and efficiencyCMS-1612-FC 868

of care. The measure specifications will con tinue to align with the EHR Incentive Program definitions of hospital-based providers and w ill exclude observation services, accordingly. The measure specifications include Medicare and Medicai d eligible PCPs. Pract itioners other than

PCPs are not included in the measure at this time in efforts to focus on the meaningful use of certified EHRs in the provision of primary care services. This measure aligns with other HHS initiatives that suppor t the adoption and meaningful us e of certified EHR technology. For example, the HHS Office of the National Coordi nator for Health Information Technology and CMS are managing $27 billion in funding from the American Recovery and Reinvestment Act of 2009 and other sources to promote the adoption of electronic health record s (EHR) in hospitals

and doctor’s offices 12 . More than 75 percent of eligible health care professionals, and over 90 percent of eligible hospitals, have already qua lified for EHR incentive payments for using certified EHR technology. Retaining this measur e in the quality performance standard for the Shared Savings Program will help provide an ad ditional and appropriate incentive to reinforce the adoption and meaningful use of certified EHR technology. Finally, performance on this measure is determined using EHR Incentive Pr ogram data and due to the EHR Incentive Program timelines and data collection, CMS will not be able to provide lists of EPs to ACOs throughout the performance year.

Final Decision: After consid eration of the comments re ceived, we are finalizing the proposal to modify the name and specificati ons of ACO-11 to the Percent of PCPs who successfully meet MU requirements.

e. Measures submitted thr ough the CMS web interface

12 http://www.hhs.gov/news/press/2014pres/09/20140916a.htmlCMS-1612-FC 869

To align with PQRS, we proposed to add several measures submitted through the CMS

web interface that we believed were appropriate for the ACO quality performance standard. The measures we proposed to add were:

● Depression Remission at Twelve Months (NQF #0710).

● Diabetes Measures for Foot Exam and Eye Exam (NQF #0056 and #0055).

● Coronary Artery Disease (C AD): Symptom Management.

● Coronary Artery Disease (CAD): Beta Bloc ker Therapy—Prior Myocardial Infarction (MI) or Left Ventricular Systolic Dysfunction (LVEF<40%) (NQF #0070).

● Coronary Artery Disease (CAD): An tiplatelet Therapy (NQF #0067).

● Documentation of Current Medications in the Medical Record (NQF #0419).

Additionally, we identified a number of th e existing measures submitted through the CMS web interface that have not kept up with cl inical best practice, are redundant with other measures that make up the quality performance st andard, or that could be replaced by similar measures that are more appropriate for ACO qual ity reporting. For the r easons specified in the proposed rule, we proposed to no longer coll ect data on the following measures, and these measures would no longer be used for establishi ng the quality performance standards that ACOs must meet to be eligible to share in savings:

● ACO #12, Medication Reconcilia tion after Discharge from an Inpatient Facility.

● ACO #22, Diabetes Composite measure: He moglobin A1c control (<8 percent).

● ACO #23, Diabetes Composite: Low Dens ity Lipoprotein (<100) (NQF #0729).

● ACO #24, Diabetes Composite: Blood Pr essure (<140/90) (NQF #0729).

● ACO #25, Diabetes Composite: Tobacco Non-use (NQF #0729).CMS-1612-FC 870

● ACO #29, Ischemic Vascular Disease: Comp lete Lipid Profile and LDL Control (<100 mg/dl) (NQF #0075).

● ACO #30, Ischemic Vascular Disease: Use of Aspirin or another Antithrombotic (NQF #0068).

● ACO #32, Coronary Artery Disease (CAD) Composite: Drug Therapy for Lowering LDL Cholesterol (NQF #74). Finally, given these proposed changes, we also proposed updates and revisions to the Diabetes and CAD Composite meas ures. We proposed that the Di abetes Composite include the following measures:

● ACO #26: Diabetes Mellitus: Daily Aspi rin or Antiplatelet Medication Use for

Patients with Diabetes Mellitus an d Ischemic Vascular Disease.

● ACO #27: Diabetes: Hemoglobin A1c Poor Control.

● ACO #41: Diabetes: Foot Exam.

● ACO #42: Diabetes: Eye Exam. We further proposed that the CAD Com posite include the following measures:

● ACO #33: Angiotensin-Converting Enzyme (ACE) Inhibitor or Angiotensin Receptor Blocker (ARB) Therapy – Diabetes or Left Ventricular Systolic Dysfunction (LVEF<40%).

● ACO #43: Antiplatelet Therapy.

● ACO #44: Symptom Management.

● ACO #45: Beta-Blocker Therapy – Prio r Myocardial Infarction (MI) or Left Ventricular Systolic Dysfunction (LVEF<40%). We solicited comment on these composite meas ures and whether there are any concerns regarding the calculation of a composite score. Given th e general concerns around compositeCMS-1612-FC 871

measures and their use, we also solicited comment on how we combine and incorporate component measure scoring for the composite. Comment: Most commenters supported the proposed removal and replacement of measures that may not align with current clinical guidelines or that appear to overlap with other measures currently in the measure set. At le ast one commenter specifically opposed removal of ACO #30, Ischemic Vascular Disease: Use of Aspirin or another Antithrombotic (NQF #0068) and the LDL measures, stating that there is disagreement on guidelines among professional organizations. Others expressed concern about the number of proposed changes that will require ACOs, in turn, to make changes to their internal processes and their EHRs to facilitate data

collection. Some commenters rais ed general clinical or othe r methodological concerns about individual proposed measures submitted through th e CMS web interface. Our detailed responses

to those comments can be found in Table 79 of se ction III.K. of this final rule with comment period. We do, however, wish to note some specifi c comments relevant to our final policy decisions with respect to the qua lity performance measures used in the Shared Savings Program: (1) Commenters noted that the Patient Health Qu estionnaire 9 (PHQ-9) is sp ecified for use in the Depression Remission measure (proposed ACO # 40), and that this tool is only one of several options available to practitioners. These comm enters suggested not adding this measure until ACOs have had the opportunity to uniformly phase in the use of the PHQ-9 in order to meet the measure specification requirements. Additionall y, commenters suggested that their ability to perform well on this measure may be limited if they cannot access the PHQ-9 score data from mental health care providers. (2) Many commenters did not support the proposed addition of the CAD: Symptom Management meas ure (proposed ACO # 44), stati ng they believe the measureCMS-1612-FC 872

lack primary care focus and that there are poten tial challenges in data collection. CMS also received a comment supporting the proposed additi on of the CAD: Antiplatelet Therapy measure (proposed ACO # 43), however, this commenter recommended that if added, the measure only be used for pay-for-reporting. (3) Some comme nters did not support the retirement of the 4 Diabetes Composite measures and 1 CAD Composite measure proposed to be removed due to the resources already invested in reporting th ese 5 measures. (4) CMS received comments suggesting that the quality performance standard under the Shared Savings Program should focus on broader categories of measures (such as prev entive health measures) that are generalizable across providers and care settings , rather than measures that ta rget specific providers or care settings. Response: We continue to believe that th e quality performance measures used in the Shared Savings Program should reflect curren t clinical guidelines. We appreciate the commenters’ agreement with our proposed change s to remove and replace measures that are not in adherence with current clinical guidelines. In response to comments, included in Table 79 in section III.K , we will retain ACO #30, Ischemic Vascular Disease: Use of Aspirin or another Antithrombotic (NQF #0068). We note that we err oneously made the assertion that this measure conflicts with current clinical guidelines. Th erefore, due to the clinical importance of the measure, the measurement gap it addresses, a nd its alignment with the Million Hearts Campaign and PQRS, we will retain this measure. Given the concerns raised by commenters, included in Table 80 of section III.K, regarding our proposal to use PHQ-9 for the Depression Remission measure, we will not finalize our proposal that the measure would be phased- in to pay-for-performan ce during the second and third performance years of an ACO’s first ag reement period. We will, however, finalize ourCMS-1612-FC 873

proposal to use the measure to assess ACO qua lity, but only as pay-for-reporting for all three performance years of an ACO’s first agreement period. We believe this approach will provide flexibility for ACOs to continue to use t ools other than the PHQ-9, while providing the opportunity for ACOs to begin a dopting this tool without harmi ng their ability to achieve full points on the measure. Additi onally, as noted above, the HIPAA Privacy Rule generally provides the same protections for mental health information as it does for all protected health information (with the exception of psychotherapy notes). We therefore do not believe there would be any unusual impediments to accessing the information required for reporting of this particular measure.

After consideration of the co mments received and in order to align with the final measures that will be used in the PQRS program, we will not fina lize the CAD: Symptom Management (proposed ACO – 44) and CAD: Antiplatelet Therapy (proposed ACO – 43) measures for the Shared Savings Program. S ee section III.K, Table 79, for comment discussion and response. We believe it is important to make changes in the measures used to assess ACO quality to address the statutory mandate in section 1899(b)(3)(A) of the Act wh ich requires the Secretary to determine appropriate measures to assess the quality of care furnished by the ACO, reflect current clinical practice, prom ote high quality care, and alig nment with PQRS and National Quality Strategy. We therefore disagree with commenters that in ternal operational challenges that arise from changes in the measure set outweigh the benefit of such changes.

After considering the comments received re garding the proposed new measures, we are finalizing our proposal to add the following ne w measures that will be submitted by the ACO through the CMS web interface:CMS-1612-FC 874

• Documentation of Current Medications in the Medical Record (NQF #0419).

• Depression Remission at Tw elve Months (NQF #0710).

• Diabetes Measures for Eye Exam (NQF #0055).

For the reasons stated in s ection III.K., we decline to fi nalize our proposals to add the following measures:

• Diabetes: Foot Exam (NQF #0056)

• CAD: Antiplatelet Therapy (NQF #0067)

• CAD: Symptom Management

• CAD: Beta-Blocker Therapy – Prior Myocardial Infarction or Left Ventricular Systolic Dysfunction (LVSD) (NQF #0070) We are not finalizing our pr oposal to add the CAD: Antip latelet Therapy (NQF #0067) measure and instead will keep the measure it was designed to replace, ACO #30, Ischemic

Vascular Disease: Use of As pirin or another Antithrombotic (NQF #0068) because we have

determined that it does not conflict with clin ical guidelines, remains clinically important, addresses a measurement gap, and aligns with the Million Hearts Ca mpaign and PQRS. We

believe that retention of this measure in lieu of the proposed Antiplatelet Therapy measure will additionally reduce burden on ACOs that would otherwise need to revise their data collection processes to accommodate this change. Additionally, we are finalizi ng our proposal to remove certain measures from the ACO quality performance standard including the following:

● ACO #12, Medication Reconcilia tion after Discharge from an Inpatient Facility

● ACO #22, Diabetes Composite measure: He moglobin A1c control (<8 percent).

● ACO #23, Diabetes Composite: Low Dens ity Lipoprotein (<100) (NQF #0729).CMS-1612-FC 875

● ACO #24, Diabetes Composite: Blood Pr essure (<140/90) (NQF #0729).

● ACO #25, Diabetes Composite: Tobacco Non-use (NQF #0729).

● ACO #29, Ischemic Vascular Disease: Comp lete Lipid Profile and LDL Control (<100 mg/dl) (NQF #0075).

● ACO #32, Coronary Artery Disease (CAD) Composite: Drug Therapy for Lowering LDL Cholesterol (NQF #74). Finally, given these changes, we are revisi ng the Diabetes Compos ite to include the following measures:

● ACO #27: Diabetes: Hemoglobin A1c Poor Control (NQF #0059).

● ACO #42: Diabetes: Eye Exam (NQF #0055). Although not previously proposed, in order to align with PQRS and in response to

commenter concerns about usi ng this measure outside the co mposite, we are removing ACO #26, Diabetes Mellitus: Daily Aspi rin or Antiplatelet Medication Us e for Patients with Diabetes

Mellitus and Ischemic Vascular Disease. While we believe the measure may be valid apart from the composite, we are swayed by the concerns ra ised by commenters as discussed in Table 79 in section III.K. We believe removing ACO-26 is c onsistent with our propos als to align with the PQRS program and remove redundancy of meas ures within the Shared Savings Program measure set. In addition, we believe removing this measure will reduce reporting burden for ACOs and may also help to improve performanc e on the diabetes composite. We also note that

the removal of this measure would additio nally alleviate some redundancy with ACO #30 Ischemic Vascular Disease: Use of Aspirin or another Antithrombotic (NQF #0068) which we are retaining for the reasons discussed above. The CAD Composite will be removed since there is only one CAD measure remaining.CMS-1612-FC 876

We believe that the final measure set as adopt ed in this final rule is appropriate for purposes of the ACO quality performance standard and in order to align with changes being made to the PQRS for the reasons specified above and in Tables 79 and 80 in section III.K. Additionally, we believe that our final decision to remove certain measures will improve alignment with best practices and reduce reporting burden for ACOs. f. Summary of Changes to the ACO Quality Measures We are finalizing the ACO quality performance measures as follows. In total, we will

use 33 measures to establish th e quality performance standards that ACOs must meet to be eligible for shared savings. Although the numbe r of measures in the measure set remains at 33, we are reducing the number of measures report ed through the CMS web interface by 5 to reduce burden. In addition, as discussed in section III.K., we are also reducing the number of patients ACOs are required to report on for each measure. This change will also reduce the burden of quality reporting for ACOs. The new measures will be pay for reporting for the first two performance years for all ACOs. After this initi al period, the measures w ill be phased in to payfor-performance over the course of an ACO’s first agreement period with the exception of Depression Remission at 12 Mont hs which will stay at pay-for-reporting for all three performance years. Specifically, we are finalizing the followi ng changes to the Shared Savings Program quality measure set (see Table 81 for a list of the final measures and for further details of phase in to pay-for-performance duri ng the agreement period):

● Add the CAHPS: Stewardship of Patient Reso urces measure as pay-for-reporting in the first performance year of an ACO’s first ag reement period and pay-for-performance in the second and third performance years.CMS-1612-FC 877

● Add SNF 30-Day All-Cause Readmission measure and All-Cause Unplanned Admissions measures for Patients with Multiple Clinical Conditions, Heart Failure, and Diabetes as pay-for-reporting for the first two years of an ACO’s first agreement period before transitioning to pay for performan ce in performance year three.

● Add Depression Remission at 12 Months ( NQF #0710) measure as pay-for-reporting for all three performance years of an ACO’s first agreement period.

● Replace ACO-12 Medication Reconciliation (NQF #0097) with “Documentation of

Current Medications in the Me dical Record” (NQF #0419).

● Add Diabetes: Eye Exam (NQF #0055)

● Modify name and specifications of ACO-11 from Percent of PCPS who successfully Qualify for an EHR Incentive Program Payment to the Percent of PCPs who Successfully Meet MU Requirements. In addition, we are finalizing the retirement of 6 of the 7 measures we proposed to delete because they do not align with updated clinical gu idelines or are similar to existing measures (ACO-22, 23, 24, 25, 29, and 32). We are not fi nalizing our proposal to remove ACO-30 Ischemic Vascular Disease: Use of Aspirin orAnother Antithrombotic and are removing ACO26 Diabetes Mellitus: Daily Aspirin or Antiplate let Medication Use for Patients with Diabetes

Mellitus and Ischemic Vascular Disease due to comments received and for the reasons discussed above and in section III.K, Table 79. We are also not finalizing the following pr oposed measures, but inst ead will continue to consider them for the future given the measur ement gaps and high-cost, high-volume conditions these measures address for the quality performan ce standard as discussed in Table 79 in section

III.K:CMS-1612-FC 878

• Diabetes: Foot Exam (NQF #0056)

• CAD: Antiplatelet therapy (NQF #0067)

• CAD: Symptom management

• CAD: Beta-blocker therapy – prior Myocar dial Infarction (MI) or LVSD (NQF #0070) As a result, we will no longer ha ve a CAD composite in the meas ure set and will only have 1

CAD measure in the Clinical Care in the At-R isk Population domain (A CO# 33: AngiotensinConverting Enzyme (ACE) Inhibitor or Angi otensin Receptor Blocker (ARB) Therapy – Diabetes or Left Ventricular Sy stolic Dysfunction (LVEF<40%)). An overview of the changes we are finalizi ng is provided in Tabl e 81, which lists the

measures that will be used to assess ACO quality under the Shared Savings Program starting with the 2015 performance year.CMS-1612-FC 879TABLE 81: Measures for Use in Establishing Quality Performance Standards that ACOs Must Meet for Shared SavingsDomainACOMeasure #Measure Title New MeasureNQF #/MeasureStewardMethod of DataSubmissionPay for Performance Phase InR – ReportingP – PerformancePY1 PY2 PY3AIM: Better Care for IndividualsPatient/CaregiverExperienceACO - 1CAHPS: Getting Timely Care, Appointments, andInformationNQF #0005,AHRQSurvey RP PACO - 2CAHPS: How Well Your Doctors CommunicateNQF #0005AHRQSurvey RPPACO - 3CAHPS: Patients' Rating of DoctorNQF #0005AHRQSurvey RPPACO - 4CAHPS: Access to SpecialistsNQF #N/ACMS/AHRQSurvey RPPACO - 5CAHPS: Health Promotion and EducationNQF #N/ACMS/AHRQSurvey RPPACO – 6CAHPS: Shared Decision MakingNQF #N/ACMS/AHRQSurvey RPPACO – 7CAHPS: Health Status/Functional StatusNQF #N/ACMS/AHRQSurvey R R RACO - 34CAHPS: Stewardship of Patient ResourcesXNQF #N/ACMS/AHRQSurvey R PPCare Coordination/SafetyACO - 8Risk-Standardized, All Condition ReadmissionAdapted NQF#1789CMSClaims R RPACO - 35Skilled Nursing Facility 30-Day All-CauseReadmission Measure (SNFRM)XNQF #TBDCMS Claims R RPACO - 36All-Cause Unplanned Admissions for Patients withDiabetesXNQF#TBDCMSClaims R RPACO -37All-Cause Unplanned Admissions for Patients withHeart FailureXNQF#TBDCMSClaims R RPACO -38All-Cause Unplanned Admissions for Patients withMultiple Chronic ConditionsXNQF#TBDCMSClaims R RPACO - 9Ambulatory Sensitive Conditions Admissions:Chronic Obstructive Pulmonary Disease or Asthmain Older Adults(AHRQ Prevention Quality Indicator (PQI) #5)Adapted NQF#0275AHRQClaims RP PACO - 10Ambulatory Sensitive Conditions Admissions:Heart Failure(AHRQ Prevention QualityIndicator (PQI) #8 )Adapted NQF#0277AHRQClaims RP PACO - 11Percent of PCPs who Successfully Meet MeaningfulUse RequirementsNQF #N/ACMSEHR IncentiveProgramReportingRP PCMS-1612-FC 880DomainACOMeasure #Measure Title New MeasureNQF #/MeasureStewardMethod of DataSubmissionPay for Performance Phase InR – ReportingP – PerformancePY1 PY2 PY3ACO -39Documentation of Current Medications in theMedical RecordXNQF #0419CMSCMS WebInterfaceRP PACO - 13Falls: Screening for Future Fall RiskNQF #0101NCQACMS WebInterfaceRP PAIM: Better Health for PopulationsPreventive HealthACO - 14Preventive Care and Screening: InfluenzaImmunizationNQF #0041AMA-PCPICMS WebInterfaceRP PACO – 15Pneumonia Vaccination Status for Older AdultsNQF #0043NCQACMS WebInterfaceRP PACO – 16Preventive Care and Screening: Body Mass Index(BMI) Screening and Follow UpNQF #0421CMSCMS WebInterfaceRP PACO – 17Preventive Care and Screening: Tobacco Use:Screening and Cessation InterventionNQF #0028AMA-PCPICMS WebInterfaceRPPACO – 18Preventive Care and Screening: Screening forClinical Depression and Follow-up PlanNQF #0418CMSCMS WebInterfaceRP PACO – 19Colorectal Cancer ScreeningNQF #0034NCQACMS WebInterfaceR RPACO – 20Breast Cancer ScreeningNQF #NANCQACMS WebInterfaceR RPACO - 21Preventive Care and Screening: Screening for HighBlood Pressure and Follow-up DocumentedCMS CMS WebInterfaceR RPClinical Care for At RiskPopulation - DepressionACO – 40Depression Remission at Twelve MonthsXNQF #0710MNCMCMS WebInterfaceRRRClinical Care for At RiskPopulation - DiabetesDiabetes Composite (All or Nothing Scoring):ACO - 27: Diabetes Mellitus: HemoglobinA1c Poor ControlACO - 41: Diabetes: Eye ExamCMS CompositeACO -27NQF #0059NCQA (individualcomponent)CMS WebInterfaceRPPACO - 41 XNQF #0055NCQA (individualcomponent)CMS WebInterfaceRP PClinical Care for At RiskPopulation -HypertensionACO - 28Hypertension (HTN): Controlling High BloodPressureNQF #0018NCQACMS WebInterface RPPClinical Care for At RiskPopulation - IschemicVascular DiseaseACO-30Ischemic Vascular Disease (IVD): Use of Aspirin orAnother AntithromboticNQF #0068NCQACMS WebInterface RP PClinical Care for At RiskPopulation -Heart FailureACO - 31Heart Failure (HF): Beta-Blocker Therapy for LeftVentricular Systolic Dysfunction (LVSD)NQF #0083AMA-PCPICMS WebInterface R RPCMS-1612-FC 881DomainACOMeasure #Measure Title New MeasureNQF #/MeasureStewardMethod of DataSubmissionPay for Performance Phase InR – ReportingP – PerformancePY1 PY2 PY3Clinical Care for At RiskPopulation – CoronaryArtery DiseaseACO - 33Angiotensin-Converting Enzyme (ACE)Inhibitor or Angiotensin Receptor Blocker(ARB) Therapy – for patients with CAD andDiabetes or Left Ventricular SystolicDysfunction (LVEF<40%)NQF # 0066ACCCMS WebInterfaceR RPCMS-1612-FC 882

The current quality scoring methodology is explained in the regulations at §425.502 and in the preamble to the November 2011 final ru le (76 FR 67895 through 67900). As a result of the additions, deletions, and revisi ons to the quality measure set being made in this final rule, each of the four domains will include the following number of quality measures (See Table 82 for details.): • Patient/Caregiver Experien ce of Care – 8 measures • Care Coordination/Patient Safety – 10 measures

• Preventive Health – 8 measures • At Risk Population – 6 measures (i ncluding 5 individual measures and a 2- component diabetes composite measure) Table 82 provides a summary of the number of measures by domain and the total points and domain weights that will be used for scoring purposes under these changes. Otherwise, the current methodology for calculating an ACO’s overall quality performance score will continue to apply. Table 83 provides the meas ures that are retired/replaced.

TABLE 82: Number of Measures and Total Poin ts for Each Domain within the Quality Performance Standard

Domain Number of Individual Measures Total Measures for Scoring Purposes Total Possible Points Domain Weight Patient/Caregiver Experience 8 8 individual survey module measures 16 25%

Care Coordination/ Patient Safety 10 10 measures. Note that the EHR measure is double-weighted (4 points) 22 25%

Preventive Health 8 8 measures 16 25% At-Risk Population 7 5 individual measures, plus a 2- component diabetes composite measure, scored as one. 12 25%

Total in all Domains 33 32 66 100%CMS-1612-FC 883

TABLE 83: Shared Savings Progr am Measures Retired/Replaced

Notes Domain Measure Title NQF Measure #/

Measure Steward Method of Data Submission Pay for Performance Phase In R = Reporting P=Performance

Performance Performance Performance Year 1 Year 2 Year 3 ACO #12 Replaced Care Coordination/ Patient Safety Medication Reconciliation: Reconciliation After Discharge from an Inpatient Facility NQF #97AMAPCPI/NCQA GPRO Web Interface R P P

ACO #22 Retired At Risk Population - Diabetes Diabetes Composite (All or Nothing Scoring): Hemoglobin A1c Control (<8 percent) NQF #0729 MN Community Measurement GPRO Web Interface R P P

ACO #23 Retired At Risk Population - Diabetes Diabetes Composite (All or Nothing Scoring): Low Density Lipoprotein (<100) NQF #0729 MN Community Measurement GPRO Web Interface R P P

ACO #24 Retired - Redunda nt Measure At Risk Population - Diabetes Diabetes Composite (All or Nothing Scoring): Blood Pressure <140/90 NQF #0729 MN Community Measurement GPRO Web Interface R P P

ACO #25 Retired - Redunda nt measure At Risk Population - Diabetes Diabetes Composite (All or Nothing Scoring): Tobacco Non Use NQF #0729 MN Community Measurement GPRO Web Interface R P P

ACO # 26 Retired - redundan t measure At Risk Population – Diabetes Diabetes Composite: Daily Aspirin or Antiplatelet Medication Use for Patients with Diabetes Mellitus and Ischemic Vascular Disease GPRO Web Interface R P P

ACO #29 Retired At Risk Population – Ischemic Vascular Disease Ischemic Vascular Disease (IVD): Complete Lipid Profile and LDL Control <100 mg/dl NQF #75 NCQA GPRO Web Interface R P P

ACO #32 Retired At Risk Population – Coronary Artery Disease Coronary Artery Disease (CAD) Composite: All or Nothing Scoring: Drug Therapy forLowering LDLCholesterol NQF #74 CMS (composite) / AMA-PCPI (individual component) GPRO Web Interface R R P

We believe that these modifications to the quality measure set fo r the Shared Savings Program will further enhance the quality of care patients receive from ACO participants andCMS-1612-FC 884

ACO providers/suppliers, better reflect clinic al practice guidelines, streamline measures reporting, and enhance alignment with PQ RS and the EHR Incen tive Program. g. Effective date and phase in of quality measures. Proposal: We proposed that these measures changes would become effective beginning with the 2015 reporting period, and the 2015 performa nce year (PY). We also proposed that all quality measures would be phased in for ACOs with 2015 start dates according to the phase-in schedule in Table 81. We proposed that ACOs with start dates before 2015 would be responsible only for complete and accurate reporting of the new measures for the 2015 performance year and then responsible for either reporting or perfor mance on measures according to the phase in

schedule. Comment: Most commenters did not separa tely provide comment s on this specific proposal regarding the effective date for measure changes but addressed the general issue as part

of their comments on individual measures or rela ted issues, especially with respect to the effective date for benchmarking purposes. Howe ver, a number of commenters disagreed with the proposal to move certain new measures to pa y for performance after only one year of pay for reporting. They suggested that an additional year of pay for reporting would be needed in order to adequately and fairly set benchmarks for pay for performance, especially for measures that have not been previously tested in any large s cale health system and ma y be newly or not yet accredited by the National Quality Forum (NQF). Response: We are finalizing ou r proposal that quality measures will become effective for the Shared Savings Program quality performance standard beginning in 2015 and the phase-in schedule indicated in Table 81. Additionally, we are convinced by commenters that believe that an additional year of pay for reporting is n eeded by CMS and ACOs to fully implement new measures. Therefore, each new measure will be pay-for-reporting for its first two reportingCMS-1612-FC 885

periods in use. This additional time will help to ensure that ACOs have adequate time to phase in their own care processes and infrastructure be fore they are held accountable for performance and that CMS has adequate data to set benchmar ks for new measures before they transition to pay for performance according to the phase-in sche dule in Table 81. In other words, the phase-in schedule indicated in Table 81 applies to a m easure after it has been pay-for-reporting for the first two reporting periods it is in use. In this case, the new measures we are finalizing will be pay-for-reporting for the 2015 and 2016 reporting periods, which will take precedence over the phase-in schedule for ACOs that are currently pa rticipating in the Shared Savings Program. Using new measures as pay-for-reporting for the first two reporting periods they are in use will provide adequate time and data necessary to set the benchmarks for the 2017 reporting period when the measures will transition to pay for pe rformance under the phase in schedule indicated

in Table 81. For example, assume a new measure is sche duled to phase in w ith reporting in PY1, reporting in PY2, and performance in PY3. Furthe r assume that an ACO with a 2014 start date will be in its second performance year (PY2) wh en the measure becomes effective. In this example, according to the performance year phas e-in schedule, the ACO would be responsible for complete and accurate reporting of the new measure in PY2 and for performance on the measure in PY3. However, because the measur e is new and will be pay-for-reporting for the 2015 and 2016 reporting periods, this overrides the phase-in schedule because we would not

have benchmark information for this ACO’s PY3. In this example, if the ACO renews its participation agreement for a new agreement pe riod then the ACO woul d be responsible for performance on the measure in PY1 of its ne w agreement period, because the measure was scheduled to be pay-for-performa nce in PY3 of the previous agr eement period. If we change the assumptions in the example to an ACO with a start date of 2015, under the phase-in schedule theCMS-1612-FC 886

ACO would be responsible for performance in PY3 which co rresponds with the 2017 reporting period, the first year in which th e measure is available to be us ed for pay-for-performance. In other words, each new measure is pay-for-repor ting until it is possible to use it as pay-forperformance, and whether the ACO is subject to pay-for-performance at that time is determined by the phase-in schedule in Table 81. We are also revising §425.502(a)(4 ) to provide that the quality performance standard for a newly introduced measure is set at the level of complete and accurate re porting for the first two reporting periods for which report ing of the measure is require d. For subsequent reporting periods, the quality performance standard for the measure will be assessed according to the phase-in schedule for the measure. h. Aligning with PQRS sampling methodology Proposal: As noted in the November 2011 Shared Savings Program final rule (76 FR 67900), the Shared Savings Program uses the same sampling method used by PQRS GPRO. Specifically, the sample for the ACO GP RO must consist of at least 411 assigned beneficiaries per measure set/domain. If the pool of eligible, assigned beneficiaries is less than 411, the ACO must report on 100 percent, or all, of the assigned beneficiaries sampled. In the proposed rule, we stated that to the extent that PQRS modifies and finalizes changes in the reporting requirements for group practices reporti ng via the GPRO web inte rface, we proposed to make similar modifications to ACO reporting thr ough the GPRO web interface. Specifically, as

discussed in section III.K. of this final rule with comment period, we proposed to reduce the GPRO web interface minimum reporting requirem ents for PQRS reporting from 411 to 248 consecutively ranked and assigned patients for e ach measure or 100 percent of the sample for each measure if there are less than 248 patients in a given sample. We proposed that the reduced sample for each measure for reporting through th e GPRO web interface would also apply toCMS-1612-FC 887

ACOs. We stated that we believe that a reduc tion in the number of sampled beneficiaries would reduce reporting burden for ACOs while maintaining high statistical validity and reliability in

results. Comment: We received relatively few comments on this proposal, but most of those that commented supported the proposal. A majority of commenters also supported the PQRS proposal to reduce the reported sample size for groups of 100 or more EPs, and agreed that this smaller sample size would reduce reporting burden (please refer to section III.K.). However, a

few commenters were concerned that a sample size of 248 may not adequately or accurately represent the diversity of an ACO’s providers and suppliers, es pecially for larger ACOs. These ACOs can include mixed models of employed a nd independent-affiliated provider practices. Therefore, these commenters support reducing the sample size requirement only for smaller ACOs, such as those ACOs with 5,000 to 10,000 a ssigned beneficiaries. Alternatively, these commenters request that ACOs be given the option to continue to report a larger sample size if they prefer. A commenter also as ked that CMS publish results that support the statistical validity and reliability of the proposed reduction of the sample from 411 to 248. Response: Specific responses to comments on this proposal can be found in section III.K.4.a. of this final rule with comment period. We appreciate the comments from stakeholders that support the proposal to reduce the sample size and agree that this change will reduce reporting burden for ACOs. Moreover, commenters ag reed that a reduction in the sample size to

248 would continue to be statistic ally valid and reliable. As di scussed in section III.K.4.a, our internal assessments performed fo r PQRS confirm this conclusion. Additionally, we clarify that

the GPRO web interface tool will continue to contain an overs ample of 616 patients at it has previously, however, the number required for reporting is being reduced from 411 to 248. Because we have concluded that a sample of 248 is statistically valid and reliable, we disagreeCMS-1612-FC 888

that the reduced sample size will not adequately represent the diversity of the ACO’s providers and suppliers. Further, we do not have a mechan ism that would allow us to deviate from the established methodology used by the GPRO web in terface, and therefore cannot offer an option

at this time for ACOs to choose to be assessed on more than 248 patient s. As noted above, the tool oversamples up to 616 patients, and ACOs ma y choose, but are not required, to report on all 616. We oversample to allow ACOs to include beneficiaries for quality reporting to replace

beneficiaries ACOs are unable to report on, due to exclusions , so they can complete the minimum required number of patients. However, in accordance with the methodology previously adopted under PQRS , the ACO would only be assessed based on reporting for 248 patients using the existing sampling methodology that otherwise has been prev iously established. In order to align with the po licy being finalized for PQRS, we are reducing the required number of consecutively ranked patients re ported for each measure module through the CMS web interface from 411 to 248. Because ACOs repor t using the same web interface tool used by PQRS, this reduction in the required sample si ze for reporting will reduce burden, while ensuring statistical validity and reliability is maintained. It also ensures consistency and equal treatment for all groups reporting through the GPRO web interface. 3. Request for Comments for Future Quality Measures In the proposed rule (79 FR 40483), we indicated that in a ddition to the changes to the current set of measures for the Shared Savings Program discussed above, we were interested in public comment on additional measures that we may consider in future rulemaking. We particularly welcomed comments regarding the following issues:

● Gaps in measures and additional sp ecific measures: We solicited comments on specific measures or measure groups that may be c onsidered in future rulemaking to fill in gaps that may exist for assessing ACO quality performance.CMS-1612-FC 889

● Caregiver experience of care: We solicited comment on additional specific caregiver experience of care measures that might be considered in future rulemaking.

● Alignment with Value-Based Payment Modifier (VM) measures: We solicited comment on whether there are synergies that can be created by aligning the ACO quality

measure set with the measures used under the VM . Although we did not propose any changes to align with the measures used under the VM , we did seek comment on whether the VM composites should be considered in the future as a replacement for the two ACO claims-based ambulatory sensitive conditions ad missions (ASCA) measures.

● Specific measures to assess care in the frail elderly population: We welcomed comments with suggestions of new measures of the quality of care furnished to the frail elderly population that we may consider adopting in future rulemaking.

● Utilization: We welcom ed comments on whether it is sufficient for utilization

information to be included in the aggregate quarterly reports to ACOs or whether utilization

measures should also be used to assess the ACO’ s quality performance as an added incentive to provide more efficient care. If commenters we re interested in having utilization measures included in the quality performance standa rd, we welcomed specific comments on what utilization measures would be most appropriate for future consideration and suggestions for how to risk adjust these measures.

● Health outcomes: We welcomed suggesti ons as to whether and when it would be appropriate to include a self-re ported health and functional st atus measure in the quality performance standard. We speci fically welcomed comments on the appropriateness of using a tool such the Health Outcomes Survey for hea lth plans which assesses changes in the physical

and mental health of individual beneficiaries over time. We also we lcomed suggestions for alternatives to self-reported measures th at may be considered in the future.CMS-1612-FC 890

● Measures for retirement: We solicited input from commen ters on any measures that

should be considered for retirement in futu re rulemaking. We welcomed comments on whether to continue to require ‘topped out” measures be included as pay for reporting measures. In addition, we noted that we we re proposing changes to the benchmarking methodology for topped

out measures.

● Additional public health measures: In th e proposed rule, we noted that we may propose to include an additional preventive heal th measure in the quality measure set under the Shared Savings Program in future rulemaking. Specifically, we indi cated that we were considering adding “Preventive Ca re and Screening: Unhealt hy Alcohol Use: Screening and Brief Counseling” (NQF #2152). This meas ure would reflect screening of Medicare beneficiaries covered under the existing Medicar e benefit referred to as the “Screening and Behavioral Counseling Interventi ons in Primary Care to Reduce Alcohol Misuse” benefit. We welcomed comments on the potential addition of th is measure and noted that we would consider any comments received in developing any futu re proposal with respect to this measure.

Comment: Commenters identified a wide variety of specific measure gap areas that we should address, such as COPD, care coordina tion, medication management and adherence, preventive care/adult immunizations, pain, ma lnutrition, wounds, bladde r control, outcome measures and cost/efficiency/utilization rela ted measures. Some commenters provided suggestions for specific measures that we shoul d consider in future rulemaking while other commenters provided more general suggestions about the types of additional measures that we should consider. For example, some commenter s suggested that quality measures should be primarily designed to protect beneficiaries from inappropriate reductions in services by ACOs.

Other commenters noted that to improve care for beneficiaries, the measures should focus on areas where: (a) CMS believes Medi care beneficiaries are receiving poor care today; and (b) it isCMS-1612-FC 891

feasible for an ACO to make changes in care th at would improve care in those areas using the

limited resources available in th e Shared Savings Program. Othe rs opposed utiliz ation measures, believing these types of measures are not necess ary within the Shared Savings Program because

of the inherent incentive for AC Os participating in the program to reduce unnecessary services and achieve savings. A comme nter supported adding public health measures “...to help

overcome the difficulties inherent in procedure-based measures th at capture limited volumes of experience in rural settings.” This commenter provided additional suggestions, such as that we exercise caution in interpreting results from self -reported measures, because of a tendency of rural respondents to understate th e true burden of chronic illness and travel. Another commenter emphasized that measure development should not entirely focus on outcomes measures because process measures can also improve outcomes. So me measures without clear clinical evidence (that is, lacking NQF endorsement ) should be avoided. Furthermore, survey measures should be minimal (and not heavily weighted) due to subjectiv ity, cost of collection, and risk of inaccurate representation based on response rate. This comm enter also recommended that the number of measures required to be reported should be re alistic and CMS should move toward the use of composites and outcome measures. Refining the measurement strategy in this way over time will allow for ACOs to mature in function, whic h takes a few years, and CMS should structure measure selection and performance measurement to reflect growth from fledgling ACO to a mature ACO. CMS should set up data reporting to be automated as much as possible. Finally, a commenter suggested that complementing the measurement strategy should be a forum for communication among ACO participants to share be st practices and lessons learned. Comments regarding “topped out” measures fo r retirement are included in the discussion below regarding the adjustment of the benchmarks for “topped out” measures. Response: We appreciate receiving the many thoughtful suggestions. We will considerCMS-1612-FC 892

these suggestions further as we develop any fu ture proposals for additional measures for the Shared Savings Program, which we would implement through rulemaking. 4. Electronic Reporting of Quality Measure Data We believe that certified EHR technology used in a meaningful way is one piece of a

broader health information technol ogy infrastructure needed to re form the health care system and improve health care quality, efficiency, and pa tient safety. Through our programs such as the

Medicare and Medicaid EHR Incentive Programs and the Stage 2 meaningful use (MU) requirements we seek to expand the meaningful use of certified EHR technology (CEHRT). Adoption of CEHRT by ACO participants and AC O providers/suppliers ma y help support efforts to achieve improvements in patient care and qua lity, including reductions in medical errors, increased access to and availability of records and data, improved clinical decision support, and the convenience of electronic prescribing. Additi onally, we believe that the potential for the Shared Savings Program to achieve its goals c ould be further advanced by direct EHR-based quality data reporting by ACOs and their ACO pa rticipants and ACO providers/suppliers. This could help reinforce the use of CEHRT, re duce errors in quality measure submission, and

achieve data submission efficiencies. We believe ACOs and their provider s should be leaders in encouraging EHR adoption and should be using CE HRT to improve quality of care and patient safety and to reduce errors. Furthermore, beginning in 2015, eligible professionals that do not successfully demonstrate meaningful use of CEHRT will be subject to a downward payment adjustment under Medicare that starts at -1 percent and increa ses each year that an eligible professional does not demonstrate meaningful use, to a maximum of -5 percent. A final rule establishing the requirements of Stage 2 of the Medicare EHR Incentive Program appeared in the September 4,

2012 Federal Register (Medicare and Medicaid Programs; Electronic Health Record IncentiveCMS-1612-FC 893

Program—Stage 2 Final Rule) (77 FR 53968). Include d in this final rule are the meaningful use and other requirements that apply for the pa yment adjustments under Medicare for covered professional services provided by eligible profe ssionals failing to demonstrate meaningful use of CEHRT, including the CQM reporting component of meaningful use. As previously discussed in section III.M.2, we are finaliz ing a proposal to revise the name and the specifications for the quality measure regarding EHR adoption to ta ke the changing incentives into account. Specifically, we are changing the name of ACO #11 from “Percent of PCPs Who Successfully Qualify for an EHR Incentive Program Payment” to “Percent of PCPs Who Successfully Meet Meaningful Use Requirements” to more accu rately reflect what is being measured. Additionally, under a group repor ting option established for the Medicare EHR Incentive Program (77 FR 54076 through 54078), EPs participat ing in an ACO under the Shared Savings Program who extract the data necessary for the ACO to satisfy the quality reporting requirements of the Shared Savings Program from CEHRT would satisfy the CQM reporting component of meaningful use as a group for the Medicare EHR Incentive Program. In addition to submitting CQMs as part of an ACO, EPs have to individua lly satisfy the other objectives and associated measures for their respective stage of meaningful use. However, we clarified that if an EP intends to use this group reporting option to meet the CQM reporting component of meaningful use, then the EP would have to extract all of its CQM data from a CEHRT and report it to the ACO (i n a form and manner specified by the ACO) in order for the EP to potentially qualify for the Medicare EHR Incen tive Program. The ACO must also report the GPRO web in terface measures and satisfy th e reporting requirements under the Shared Savings Program in order to its EP s to satisfy the CQM reporting component of meaningful use for the Medicare EHR Incentive Program.CMS-1612-FC 894

Although these group reporting re quirements were establis hed under the Medicare EHR Incentive Program, the Shared Savings Program re gulations were not amended to reflect these reporting requirements. Therefor e, we proposed to amend the regulations governing the Shared Savings Program to align with the requirement s previously adopted under the Medicare EHR Incentive Program in order to provide that EPs participating in an ACO under the Shared Savings Program can satisfy the CQM reporting co mponent of meaningful use for the Medicare EHR Incentive Program when the ACO reports GPRO web interface measures by adding new paragraph (d) to §425.506. We proposed that th is new paragraph woul d provide that EPs participating in an ACO under the Shared Savings Program satisfy the CQM reporting component of meaningful use for the Medicare EHR Incentive Program when: (1) the eligible professional extracts data necessary for the AC O to satisfy its quality reporting requirements from CEHRT; and (2) the ACO satisfactorily re ports the ACO GPRO measures through a CMS

web interface. Although we did not propose any new requi rements regarding EHR based reporting under the Shared Savings Program, we welcomed suggestions and comments about issues which we would consider in developing any future proposals. We es pecially solicited comment on the feasibility of an ACO to be a convener and s ubmitter of quality measures through an EHR or

alternative method of elect ronically reporting quality measures to us. We indicated our interest in the opportunities and barriers to ACO EHR qu ality measure reporting, as well as ways to overcome any barriers. We also welcomed s uggestions on alternative ways that we might implement EHR-based reporting of quality measur es in the Shared Savings Program, such as directly from EHRs or via data submission vendors. We solicited comment on whether EHR reporting should be a requirement for all Shared Savings Program ACOs or if the requirement for EHR reporting should be phased in gradually, for instance through a separate risk track or byCMS-1612-FC 895

the establishment of a “core and menu” quality measure set approach in which we would establish a core set of required quality measures and then supp lement these required measures with a menu of additional measures (such as EHR-based reporting) from which an ACO could choose. This approach could provide ACOs with additional flexibility and allow them to report on quality measures that better refl ect any special services they pr ovide. As an alternative, we also solicited comment on whether ACO provide rs/suppliers could use a local registry-like

version of the GPRO web interf ace to capture relevant clinical information and to monitor performance on all Medicare patients throughout the year and to more easily report quality data to CMS annually. Comment: We received a wide variety of suggestions from ACOs and other stakeholders. Most ACOs support CMS’s decisi on not to propose any new requirements at this time regarding EHR based reporting, and they ag ree with aligning the Shared Savings Program with the EHR Incentive Program whereby EPs pa rticipating in an AC O can satisfy the CQM reporting component of meaningful use when the EP extracts da ta necessary for the ACO to satisfy its quality reporting re quirements using a CEHRT and the ACO satisfactorily reports the GPRO measures through the CMS web interface. Some commenters believe the technical and operational barriers outlined in the proposed rule were severely understated. Healthcare Information and Management Systems Societ y (HIMSS) considered requiring EHR-based reporting of quality measures in the Shared Sa vings Program to be premature. Commenters

raised concerns that the current lack of inter operability capabilities for ACOs that are formed by disparate organizations, often hospitals a nd physician groups coming together, but using differing EHR platforms that do no t communicate electronic data su fficiently to centralize data for quality reporting would limit the ability of AC Os to successfully report quality through an EHR. They state it will take significant resources and time to ensure that interoperability isCMS-1612-FC 896

achieved. Rather than requiring EHR-based repo rting, some commenters suggested that CMS should give providers the op tion to report through EHRs. Response: We appreciate the comments reco mmending that we not establish any new requirements at this time regarding EHR based re porting under the Shared Savings Program. We also appreciate the comments supporting aligni ng the Shared Savings Program with the EHR Incentive Program whereby EP participating in an ACO can satisfy the CQM reporting component of meaningful use when the EP extrac ts data necessary for the ACO to satisfy its GPRO reporting requirement using a CEHRT a nd the ACO satisfactorily reports the GPRO measures through the CMS web interface.

We will continue to work toward electronic reporting of quality measures, keeping in mind the unique relationship ACOs have with their ACO participants and ACO providers/suppliers. We understa nd and appreciate the feedback from those stakeholders who raised important concerns about the readine ss of ACOs and EHR sy stems to report quality electronically under the Shared Savings Progr am. We will use the information provided by

commenters to work with ACOs and other stakeh olders to develop possible ways to encourage EHR adoption taking into account input from ACOs on challenges for ACO electronic collection and submission of measures. In addition, we will consider the input we have received from stakeholders when deciding what additional requirements should be proposed in future rulemaking to encourage EHR adoption and use by ACOs and their ACO participants and ACO providers/suppliers.

After consideration of the comm ents received regarding this proposal, we are finalizing our proposal to codify in the Shared Savings Program rules for 2015 and beyond that an eligible professional that is an ACO provider/supplier can satisfy th e CQM reporting component of meaningful use when the eligible professional extracts data fr om CEHRT necessary for the ACOCMS-1612-FC 897

to satisfy its quality repor ting requirements under the Shared Savings Program and the ACO reports the GPRO measures through the CMS web interface. This policy will be codified at § 425.506(d) of the Shared Savings Program regulations . We emphasize that if an EP intends to use this group reporting option to meet the CQM reporting component of m eaningful use, then

the EP would have to extract all its CQM data from a CEHRT and report it to the ACO (in a form and manner specified by the ACO) in orde r for the EP to potentially qualify for the Medicare EHR Incentive Program. The ACO must also report the GPRO measures through the

CMS web interface in order for its EPs to sati sfy the CQM reporting com ponent of meaningful use for the Medicare EHR Incentive Program. Although this amendment to the regulations will align the Medi care Shared Savings Program regulations with the existing requireme nts under the Medicare EHR Incentive Program, we intend to take steps in the future to better align and integrate EHR use into quality reporting under the Shared Savings Program. 5. Quality Performance Benchmarks a. Overview of Current Requirements Section 1899(b)(3)(C) of the Ac t directs the Secretary to “es tablish quality performance standards to assess the quality of care furnished by ACOs” and to “seek to improve the quality of care furnished by ACOs over time by specifying higher standards, new measures, or both for purposes of assessing such quality of care.” Under the current Shared Savings Program regulations at §425.502, the following requirement s with regard to establishing a quality performance benchmark for measures apply: (1) during the first performa nce year of an ACO’s agreement period, the quality performance standard is set at the level of complete and accurate reporting; (2) during subsequent performance year s, the quality performance standard will be phased in such that ACOs will be assessed on their performance on certain measures (see Table 1CMS-1612-FC 898

of the November 2011 Shared Savings Program final rule (76 FR 67889 through 67890), for

details of the transition for each of the 33 meas ures); (3) we designate a quality performance

benchmark and minimum attainment level for each measure, and establish a point scale for the level of achievement on each measure; and (4) we define quality performance benchmarks using FFS Medicare data or using flat percentages when the 60 th percentile is equal to or greater than 80.00 percent. Section 425.502(b)(2) governs the data that CMS uses to esta blish the quality performance benchmarks for quality performance measures under the Shared Savings Program. Consistent with section 1899(b)(3)( C) of the Act, which requires CMS to seek to improve the quality of care furnished by ACOs participati ng in the Shared Savings Program over time, §425.500(b)(3) states that in establishing the measur es to assess the quality of care furnished by an ACO, CMS seeks to improve the quality of care furnished by ACOs over time by specifying higher standards, new measures, or both. Subsequently, we discussed several issues related to the establishment of quality performance benchmarks in the CY 2014 PFS final rule with comment period (78 FR 74759 through 74764). In that rule (78 FR 74760), we finalized a proposal to combine all available Medicare FFS quality data, includi ng data gathered under PQRS (through both the GPRO web interface tool and other quality re porting mechanisms) and other relevant FFS quality data reported to CMS (including data submitted by Shared Savings Program and Pioneer ACOs) to set the quality performance benchmarks for 2014 and subsequent reporting periods. In establishing this policy, we determined that it wa s appropriate to use all FFS data rather than only ACO data, at least in the ea rly years of the program, to avoi d the possibility of punishing high performers where performance is generall y high among all ACOs. We did not finalize a proposal to use Medicare Advantag e (MA) data alone or in combination with FFS data in theCMS-1612-FC 899

short-term. Instead, we stated in the CY 2014 PFS final rule with comment period (78 FR 74760) that we intended to revisit the policy of using MA data in future rulemaking when we have more experience set ting benchmarks for ACOs. Additionally, in the CY 2014 PFS final rule with comment period, we retained the ability to use flat percentages to se t benchmarks when many reporters demonstrate high achievement on a measure, so that ACOs with high performan ce on a measure are not pe nalized (78 FR 74760). More specifically, we will now use all available FFS data to calculate benchmarks, including ACO data, except where performance at the 60 th percentile is equal to or greater than 80 percent for individual measures. In these cases, a flat percentage will be used to set the benchmark for the measure. This policy allows ACOs with hi gh scores to earn maximum or near maximum quality points while still allowi ng room for improvement and re warding that improvement in subsequent years. As previously discussed, the first performan ce year of an ACO’s agreement period is pay for reporting only, so ACOs earn their maximum sharing rate for completely and accurately reporting all 33 quality measures. Quality performance benchmarks are released in subregulatory guidance prior to the start of the quality reporting period for which they apply so that as we phase in measures to pay for performance, ACOs are aware of the actual performance rates they will need to achiev e to earn the maximum quality po ints under each domain. In the November 2011 Shared Savings Progra m final rule, we indicated our intent to gradually raise the

minimum attainment level to continue to ince ntivize quality improvement over time and noted that we would do so through future rulemaking af ter providing sufficient advance notice with a comment period to allow for i ndustry input (76 FR 67898). In the CY 2014 PFS final rule with comment period, we reiterated our policy of setti ng quality performance benchmarks prior to the reporting year for which they would apply (78 FR 74759). Specifically, we use data submitted inCMS-1612-FC 900

2013 for the 2012 reporting period to set the qua lity performance benchmarks for the 2014 reporting period. However, we recognize that in the first few years of the Shared Savings Program, we will only have a limited amount of data for some measures, which may cause the benchmarks for these measures to fluctuate, possibly making it difficult for ACOs to improve upon their previous year’s performance. Stakeholders have also told us that they prefer to have a stable benchmark target so that they can be re warded for quality improvement from one year to the next. Therefore, instead of modifying quality performance benchmarks annually, in the CY 2014 PFS final rule with comment period (78 FR 74761) we stated that we would set the benchmarks for the 2014 reporting year in ad vance using data submitted during 2013 for the 2012 reporting year, and continue to use that be nchmark for 2 reporting y ears (specifically, the 2014 and 2015 reporting years). We further indicated our intention to revisit this issue in future rulemaking to allow for public comment on the a ppropriate number of y ears that a benchmark should apply before it is updated. b. Revisions for Benchmarking M easures That Are “Topped Out”

In the discussion of measures in the CY 2015 Physician Fee Schedule proposed rule, we indicated that some measures may be topped out, meaning that all but a very few organizations achieve near perfect performance on the measure. Since publication of the quality performance benchmarks for the 2014 and 2015 quality reporting years, a number of AC Os have noted that using available national FFS data has resulted in some benchmarks where the 80th or 90th percentiles approach 100 percent performance on the measure. Stakeholders have suggested it is unreasonable to hold organizations, especially very large organizations such as ACOs to this high standard and that it may be easier for sm aller and medium size physician practices to achieve higher levels of perfor mance given their smaller patient populations. We believe these concerns have merit because we have looked at the FFS data submitted to CMS and agree it isCMS-1612-FC 901

possible that smaller practices or practices with smaller populations may be able to achieve these higher levels of performance more easily than la rger practices or organizations with larger patient populations. Therefore, we proposed certain modifications to our benchmarking methodology to address the way that such “toppe d out” measures are treated for purposes of evaluating an ACO’s performance. Specifically, when the national FFS data results in the 90th percentile for a measure are greater than or equa l to 95 percent, we would use flat percentages for the measure, similar to our policy under §425.502( b)(2)(ii) of using flat percentages when the 60th percentile is greater than 80 percent to address clustered measur es. We believe this approach would address concerns about how topped out measures affect the quality performance standard while continuing to re ward high performance, and being readily understandable to all. We proposed to revise §425.502(b)(2)(ii) to reflect this policy. We invited comments on this proposal. We also invited comm ents on other potential appro aches for addressing topped out

measures. We indicated that we would use an y comments received to help develop any future proposals regarding topped out measures. For example, we welcomed comments on whether we should drop topped out measures from the measures set, fold them into composites, or retain them but make them pay for reporting only. Comment: Commenters were generally in agreement with our proposal to use flat percentages for topped out measures, which is consistent with our policy of using flat percentages when the 60th percenti le is greater than 80 percent to address clustered measures. We received a wide variety of responses to our request for comment on what should be done with topped out measures through future rule making. Many commenters supported retaining such measures with the view that quality measur es are intended to protect Medicare beneficiaries from receiving inappropriate care. If all bu t a few organizations achieve near perfect performance, the commenters believe it would be important to retain that measure to encourageCMS-1612-FC 902

better performance from the low performing organizations, an d to prevent backsliding by the high performers. Other commenters, includ ing MedPAC, suggested removing topped out measures to reduce reporting burden. Others s uggested that topped out measures could be dropped or moved from being pro cess-based to clinical outcome-based and be folded into composites to prevent “back sliding,” or that th ey could be considered “deemed met” without a reporting requirement but availabl e for audit if so chosen. Response: We appreciate the commenters’ support for the proposal to use flat percentages when the national FFS da ta results in the 90th percenti le performing at greater than or equal to 95 percent. We also appreciat e the additional suggestions regarding treatment of topped out measures and intend to consider this issue further in future rulemaking.

Final Decision: After consid eration of the comments recei ved on this issue, we are finalizing our proposal to use fl at percentages when the nationa l FFS data results in the 90th percentile for a measure are greater than or equa l to 95 percent. We are also finalizing our proposed revisions to §425.502(b)(2 )(ii) to reflect this policy. Although this final policy is similar to our current policy for setting benchmarks based on flat percentages when the 60 th percentile is equal to or greater than 80.00 percent, we clarify that this methodology would apply to all measures, including measures whose perf ormance rates are calcul ated as ratios, for example, measures such as the ACO Ambulat ory Sensitive Conditions Admissions and the All

Condition Readmission measure. We believe it is appropriate to apply this methodology to all topped out measures, including measures whose pe rformance rates are calculated as ratios. Measures calculated and reporte d as ratios may also become topped out and we believe it is important to keep a consistent approach for addr essing all Shared Savings Program measures that become topped out.CMS-1612-FC 903

c. Quality Performance Standard for Measures that Apply to ACOs that Enter a Second or Subsequent Participation Agreement As discussed previously, during an ACO’ s first participation agreement period, the quality performance standard durin g the first performance year is initially set at the level of complete and accurate reporting, and then, during performance years 2 and 3 within the ACO’s first agreement period, the quality performance st andard is phased in such that the ACO is assessed on its performance on selected measures . We did not directly indicate the quality performance standard that would apply if an AC O were to subsequently enter into a second or subsequent participation agreement. Howe ver, §425.502(a)(1) provides that during the first performance year of an ACO’s agreement pe riod, CMS will define the quality performance standard at the level of complete and accurate reporting of all quali ty measures. As drafted, this regulation could be read to impl y that the quality performance standard for ACOs in the first performance year of a subsequent agreement period would also be set at the standard of full and accurate reporting. We do not believe it is appr opriate for an ACO in a second or subsequent agreement period to report quality measures on a pa y-for-reporting basis if they have previously reported these measures in a prior agreement pe riod. The ACO would have gained experience reporting the quality measures during the earlie r agreement period, and as a result, we do not believe it would be necessary to provide any fu rther transition period. Rather, we believe it would be appropriate to asse ss the ACO’s actual performance on measures that have been designated as pay for performance during all 3 year s of the second or subsequent participation agreement period. Accordingly, we proposed to revise our re gulations to expressly provide that during a second or subsequent participat ion agreement period, the ACO woul d continue to be assessed on its performance on each measure that has been designated as pay for performance. That is, theCMS-1612-FC 904

ACO would continue to be asse ssed on the quality performance standard that would otherwise apply to an ACO if it were in the third performa nce year of the first agreement period. We will do this by modifying §425.502(a)(1) and (a)(2) to indicate that the performance standard will be set at the level of complete and accurate repor ting of all quality meas ures only for the first performance year of an ACO’s first agreemen t period, and that during subsequent agreement periods, pay for performance will apply for all three performance years. Comment: We received relatively few comm ents on this proposal. A number of those that responded supported the proposal. A few we re hesitant to support it, suggesting that a performance standard for a quality measure s hould not be continued into a second or a subsequent participation agreement period if th ere have been any significant changes in the measure set and/or in the specifications used to calculate performance on the measures. In such cases, those measures that have changed should follow the same schedule as would apply to an ACO in its first agreement period. Another example of a concern th ese commenters raised is if an ACO with a 2013 start date (three year ag reement for 2013 through 2015) chooses to sign a subsequent three year agreement (for 2016 throug h 2018), that requires it to accept risk, then the ACO would possibly be facing new benchmar ks beginning in PY 2016 and would not be afforded a one year pay for reporting transi tion period to gain e xperience with the new

benchmarks. Response: We appreciate the comments in s upport of this proposal. We believe that concerns that were expressed by some commen ters about changes in the measure set are addressed through the phase-in schedule for ne w measures, as outlined in Table 81, and our policy, finalized above, that all new measures will be pay-for-reporting for all ACOs for the first two reporting periods in which they are in use, regardless of the phase-in schedule. This will permit time for CMS to gather data for benchmar king and publish benchmarks prior to the startCMS-1612-FC 905

of the third reporting period in which a new measur e is in use. This two year grace period will also permit ACOs to become accustomed to the m easure before it becomes pay-for-performance. So in the example given by the commenter, the ACO with a 2013 start date would not be subject to pay-for-performance in its first year of the subsequent agreement peri od (starting in 2016) for any of the new measures finalized in this rule. The first opportunity for the new measures to be used as pay-for-performance would be for the 2017 reporting period, which would correspond to this ACO’s second performance year of its s ubsequent agreement period. Because the ACO would be in its subsequent agre ement period, all measures would be pay-for-performance at that time, with the exception of measur es that remain pay-for-reporting in all years, according to the phase-in schedule indicated in Table 81. For ex ample, the Depression Remission at 12 Months measure (ACO# 40) is pay-for-reporting for all th ree years of an ACO’s first agreement period. In a subsequent agreement period, ACOs will conti nue to be assessed on this measure as pay-forreporting, which corresponds to the level of perf ormance required in PY3 of the first agreement period. Final Decision: We are finalizing our proposal to modify §425.502(a) to indicate that for ACOs in a second or subsequent agreement period, all measures will be pay for performance for all three performance years unless the measure is designated as pay-for-r eporting for all three years, as indicated in Table 81. We clarify that, as discussed in more detail above, this policy applies only to measures that have been in use for two years or more, for which benchmarks are available, and thus, would not apply to new m easures, which are designated as pay-for-reporting during the first two reporting pe riods they are in use. d. Timing for Updating Benchmarks

As discussed in the CY 2014 PFS final ru le with comment (78 FR 74761), we have further considered suggestions from ACOs rega rding the appropriate number of years that aCMS-1612-FC 906

benchmark should apply before it is updated. AC Os suggested that ther e be a longer period of time to gain experience with the performance measure, before the benchmark is further updated.

ACOs also indicated that it would be desirable to set and leave benchmarks static for additional performance years so that they have a quality improvement target to strive for that does not change frequently. ACOs believe that a stable benchmark would enhance their ability to be rewarded for quality improvement, as well as qual ity achievement, from one year to the next. We recognize, however, that there could be some concerns about lengthening the period between updates to the quality performance benchmarks . The current benchmarks as discussed previously, for example, are based on a combina tion of all available Medicare FFS quality data, including data gathered under PQ RS, the Shared Savings Progra m and Pioneer ACO Model, but not MA quality data. To the ex tent that the benchmarks are ba sed on quality data reported by a large number of ACOs and other FFS entities, we be lieve it is reasonable to use them to assess the quality performance of ACOs. Furthermore, as discussed in the 2014 PFS final rule with comment period (78 FR 74761), we ar e also persuaded that we s hould establish a longer period between updates to the benchmarks in order to provide ACOs with a more stable target for measuring quality improvement. In the absence of this stability, it could be very difficult to assess quality improvement from year to year. In the 2014 PFS final rule with comment period, we noted that we intended to address the number of years between updates to the benchmarks again in future rulemaking in order to allow for public comment. Therefore, we considered how long benchmarks should be in place before they are updated. We considered a range of options, from setti ng benchmarks every 2 years to setting benchmarks every 5 years. For example, we considered the optio n of setting benchmarks every 3 years. However, we note that ACO ag reement periods are 3 years long and a new cohort of ACOs enters the program each year. As a result, setting benchmarks every 3 years mightCMS-1612-FC 907

advantage some ACOs over others , particularly ACOs that ha ve an agreement period during which benchmarks are not updated. Therefore, we proposed to update benchmarks every 2 years. We believe 2 years is an appropriate am ount of time because the Shared Savings Program is relatively new and we do not have extensive experience in setting benchmarks under the Shared Savings Program. Updating the benchmarks every 2 years would en able us to be more flexible and give us the ability to make adjust ments more frequently if appropriate. We note, however, that we may revisit th is policy as more ACOs enter the program, more FFS data is collected which could help us better understand to what extent benchmarks should vary from year to year, or if we make any future proposals regarding the use of MA quality data for setting

benchmarks. Accordingly, we proposed to revise §425.502( b) to add a new paragraph (b)(4)(i), which would provide that CMS will update benchmarks ev ery 2 years. To illustrate this proposed policy, the existing quality performance benchmar ks, which are based on data submitted in 2013 for the 2012 reporting period would apply for a to tal of 2 performance years (the 2014 and 2015 performance years) after which we would reset the benchmarks for all ACOs based on data for the 2014 reporting period that is reported dur ing 2015. These updated benchmarks would apply for the 2016 and 2017 performance years. This time line is summarized in Table 85. Under this proposal, ACOs would have a stable target for quality achievement for 2 years, which should improve the opportunity for ACOs to be rewarded for improvement from year to year compared to that benchmark. We also proposed to revi se §425.502(b) to add a new paragraph (b)(4)(ii), which would provide that for meas ures introduced in the first y ear of the 2-year benchmarking cycle, the benchmark will be established in the second year and updated along with the other

measures at the start of the ne xt 2-year benchmarking cycle.CMS-1612-FC 908

We solicited comment on this proposal. We specifically solicited comment on the appropriate number of years that a benchmark should remain stable before it is updated. We also welcomed comments about when annual updates might be appropriate such as when there is a substantive specification change to a measure betw een years. For instance, the age range used for the breast cancer screening measure is diffe rent in 2014 than in 2013, or when the measure

owner modifies or retires a measure. Additi onally, although we proposed to retain our current policy of using the most recent available data to set the quality performance benchmarks, we also

solicited comment on whether data from other re porting periods should also be considered in establishing benchmarks that will apply for 2 perf ormance years. Specifically, we sought input on whether data from multiple years should be used to help provide more stable benchmarks. For example, should data submitted for the 2013 and 2014 reporting periods be combined to set benchmarks for the 2016 and 2017 performance years? Comment: We received a wide range of comm ents in response to this proposal. In general most commenters supported setting be nchmarks for at least two years but many, including some ACOs, supported a l onger period of at least three ye ars to align with the Shared Savings Program agreement period to provide mo re stability for ACOs. There were some commenters that suggested more frequent adjust ment of benchmarks under certain situations, suggesting that more frequent benchmark updates may be necessary whenever there are substantive specification changes for a measure, su ch as changes in the dominator or frequency. For example, a commenter stated that even slight modifications to a measure specification could eliminate any opportunity to establish a valid be nchmark and that CMS must therefore consider establishing new benchmarks when even “non-su bstantive” changes are made to measure. A commenter suggested that instead of the propos ed two year interval, benchmarks should be adjusted annually if there is a statistica lly significant performance change across allCMS-1612-FC 909

organizations. Some commenters su ggested the use of multiple year s of data to set benchmarks, suggesting, for example, that some measures coul d be susceptible to year specific events that

could skew results. Response: We are finalizing ou r proposal to set benchmarks for two years to provide ACOs with stable quality improvement targets. We believe that setting benchmarks for two years provides ACOs with stable quality improve ment targets while not advantaging some ACOs over others by setting them for three years. We also agree with commenters who suggested the use of multiple years of data to set benchmarks to reduce the effect that year to year variation might have on the benchmarks. Therefore, we will use up to 3 years of FFS data to set benchmarks, if available. This should provide sufficient stability to minimize year to year variation while also representing re asonably current practices, if the da ta is available. The use of multiple years of FFS data to set benchmarks will apply to all newly established benchmarks, but will not affect existing benchmarks, which apply to the 2014 and 2015 performance years. We are finalizing our proposal to set benchm arks for two years to provide ACOs with stable targets for quality improvement. In additio n, we will use up to three years of FFS data to set benchmarks, if available. The use of multiple years of FFS data to set benchmarks will apply to all newly established benchmarks, but will not affect existing benchmarks, which apply to the 2014 and 2015 performance years. We are finalizi ng our proposal to revi se §425.502(b) to add a new paragraph (b)(4)(i) providing th at CMS will update benchmarks every 2 years. In light of our decision to set the quality performance standard for a newly introduced measure at the level of complete and accurate reporting for the first tw o reporting periods for which the measure is in use, we are revising proposed §425.502(b)(4)(ii) to provide that for newly introduced measures that transition to pay for performance in the s econd year of the 2-year benchmarking cycle, the benchmark will be established in that year and updated along with the other measures at the startCMS-1612-FC 910

of the next 2-year benchmarking cycle. For exam ple, if a new measure is scheduled to become pay for performance in 2017 after being used fo r pay-for-reporting for 2015 and 2016, it will be set for the 2017 performance year and subsequently reset at the beginning of the next 2-year benchmarking cycle (2018-2019). In other words, such a measure would have its benchmark set for a single year before phasing into the bienni al benchmarking schedule outlined in Table 84. TABLE 84: Timeline for Setting and U pdating Quality Performance Benchmarks Reporting period for data

used to set benchmark Year data is analyzed, and benchmark is published Performance year and reporting period to which benchmark applies 2012 2013 2014 & 2015 2012, 2013, 2014 2015 2016 & 2017 2014, 2015, 2016 2017 2018 & 2019

6. Rewarding Quality Improvement a. Current Approach to Rewarding ACOs for Both Quality Attainment and Quality Improvement ACOs must meet a CMS-specified quality perfor mance standard in order to be eligible to share in savings. The Shared Savings Program qu ality performance standard currently consists of a set of quality measures spanning four domains that are collect ed via the patient and caregiver experience of care survey, calculated by CMS from internal administrative and claims data, and submitted by the ACO through the CMS web interface. The four domains include patient/caregiver experience of care, care coordi nation/patient safety, preventive health, and atrisk populations. The measures collected thr ough the CMS web interface are also used to determine whether eligible profe ssionals that bill through the TIN of an ACO participant qualify for the PQRS incentive payment or avoid the do wnward PQRS payment adjustment. Eligible professionals that bill through the TIN of an ACO participant may qualify for the PQRS incentive payment or avoid the downward PQRS payment adjustment when the ACO satisfactorily reports the ACO GPRO quality measures on their behalf.CMS-1612-FC 911

Under current policy, the quality performance st andard is defined at the level of full and complete reporting for the first performance year of an ACO’s agreement period. After that, an ACO must meet certain thresholds of performan ce and is rewarded on a sliding scale in which higher levels of quality performance translate to higher rates of shared savings. This scale, therefore, rewards improvement over time, since hi gher performance translates to higher shared savings. For example, an ACO that performs at the 80 th percentile one year and then at the 90 th percentile the next year would rece ive a higher level of shared savi ngs in its second year than its first year, based on its improved quality performance. In this way, ACOs are rewarded for both attainment and improvement. This is particularly true when benchmarks are stable for more than one year, as discussed earl ier in this section. We recognize that rewards for both quality attainment, as well as quality improvement are not always built in to pay-for-performance initiatives. For example, in HVBP (Hospital Value-Based Purchasing) hospita ls are scored based on the hi gher of their achievement or improvement on specified quality me asures, with some hospitals re ceiving incentive payments if their overall performance is high en ough relative to their peers. In the November 2011 final rule establishing the Shared Savings Program (76 FR 67897), we indicated in response to comments that we believe the approach of offering more points for better quality performance also offers an implicit incentive for continuous quality improvements, since it in corporates a sliding scale in which higher levels of quality pe rformance translate to higher shar ing rates. We believed that high performing ACOs should do we ll under this approach since it recognizes and provides incentives for ACOs to maintain high quality performance in order to maximize their share of savings and minimize their share of losses.CMS-1612-FC 912

b. Additional Rewards for Quality Improvement ACOs and other stakeholders have suggest ed that the current quality points scale described above does not adequately reward ACOs for both quality attainment and improvement. They request that we further strengthen the incentives for quality improvement by including an additional explicit reward for those ACOs th at improve from one year to the next. As discussed previously, the existing quali ty performance standard includes a sliding point scale that rewards ACOs fo r certain levels of attainment. In addition, we note that under the final policy discussed above in which we will establish a stable quality performance benchmark for a period of 2 years, there should be an even greater opportunity for every ACO to demonstrate improvement and be rewarded for that improvement from year to year. However, we were persuaded by suggestions from stakeholde rs that an additional, more explicit reward should be included for ACOs that improve their qual ity scores from year to year. Therefore, we proposed to revise our existing quality scoring strategy to explicitly r ecognize and reward ACOs that make year-to-year improvements in their qualit y performance scores on individual measures. To develop such an approach, we look ed to the MA program, which has already successfully developed and implemented a formula for measuring quality improvement. The MA five star rating program computes an impr ovement change score which is defined as the score for a measure in a performance year minus the score in the previ ous performance year. The MA five star rating program then meas ures each plan’s net quality improvement by calculating the total number of significantly improve d quality measures and subtracting the total number of significantly declined quality measures. This is an approach that we believed was also appropriate for measuring quality improvement for ACOs. (For more details on the formula for calculating the MA quality improvement meas ure, see the discussion in “Medicare 2014 Part C & D Star Rating Technical Notes”, Attachment I, page 80, which can be downloaded from theCMS-1612-FC 913

CMS website at http://www.cms.gov/Medicare/Prescription-DrugCoverage/PrescriptionDrugC ovGenIn/PerformanceData.html .) We continue to believe it is important to recognize that the Shared Savings Program is not a managed care program. Unlike MA, this program’s design retains FFS flexibility and the

freedom of choice available to beneficiaries under Medicare Parts A and B which generally necessitates different program requi rements. However, in this case we believe there would be significant advantages for the Shared Savings Program to adopt the formula for a quality improvement measure that MA has already devel oped and implemented rather than attempt to develop a new formula for a quality improvement measure. In particular, the MA measure formula has already been fully developed and vette d with stakeholders, in the context of the MA program, with detailed operational specifications and previously shared with the public. In addition, we believe it is important to add a quality improvement measure to the Shared Savings Program in a manner that woul d minimize disruption for ACOs. We believe it would be undesirable for both ACOs and the prog ram if the quality improvement measure were added in a way that required extensive revi sions to the current quality measurement methodology, for example, reweighting of the four quality measure domains. Therefore, we proposed to add a quality improvement measure to award bonus points for quality improvement to each of the existing four quality measure domains. For each quality measure domain, we proposed to award an ACO up to two addi tional bonus points for quality performance improvement on the quality measures within th e domain. These bonus point s would be added to the total points that the ACO achieved within eac h of the four domains. Under this proposal, the total possible points that could be achieved in a domain, incl uding up to 2 bonus points, could not exceed the current maximum total poi nts achievable within the domain.CMS-1612-FC 914

ACOs would achieve bonus points for this quality improvement measure in a domain if they achieve statistically significant levels of quality improvement for measures within the domain, as discussed below. Otherwise, th e current methodology for calculating the ACO’s overall quality performance score would c ontinue to apply (see §425.502(e) and 76 FR 67895 through 67900). Additional details about the pr oposal to incorporate bonus points into the quality performance scoring methodology are disc ussed in the CY 2015 Physician Fee Schedule proposed rule (79 FR 40490 through 40492). Highli ghts of the methodology we proposed are as

follows.: The quality improvement measure scoring fo r a domain would be based on the ACO’s net improvement in quality for the other measures in the domain. The calculation of the quality improvement measure for each domain would generally be based on the formula used for the MA five star rating program, as follows: Improvement Change Score = score for a measure in performance year minus score in previous performance year. In general, for a measure to be eligible to be included for purposes of determining quality improvement and awarding bonus points in a domain for a performance year, the measure must be a measure for which an ACO was scored in both the performance year and the immediately preceding performance year. Measures that were not scored in both the performance year and the immediately preceding performance year, for ex ample, new measures, would not be included in the assessment of improvement. Otherwise, for purposes of determining quality improvement and awarding bonus points, we w ould include all of the individua l measures within the domain, including both pay-for-reporting measures and pay-for-performance measures. In determining improvement, the actual performance score achi eved by the ACO on the measure would be used,

not the score used to determine shared savi ngs. In other words, we would calculate aCMS-1612-FC 915

performance score for each measure, regardless of whether it is pay for reporting or pay for performance, and include the score in the report we provide to the ACO. For example, all measures are pay for reporting in the first year of an ACO’s first ag reement period, but even though the ACO will receive full credit for all reported measures , its actual performance on those measures will also be scored and provided to th e ACO for informational purposes. We believe it is appropriate to use these actua l performance scores to assess improvement on a measure from year to year, regardless of whether the measure is designated as a pay fo r reporting or a pay for performance measure in that performance year because the performance scores achieved by the ACO provide the best indication of the actual change in quality pe rformance by the ACO. If the ACO is in its first pe rformance year of its first ag reement period, then it would not be possible, of course, to meas ure quality improvement. Therefor e, for these ACOs the existing scoring methodology would continue to apply a nd no bonus points would be awarded. If an ACO in its second or subsequent performance year does not experience an improvement nor a decline in quality performance for any of the selected measures compared to its previous reporting period, or it experiences an improvement for some measures but has an equal or greater number of measures where quality performance has declined, then the ACO would likewise not be awarded any bonus points. If an ACO re news a participation agreement, then the measurement of quality improvement would be based on a comparison between performance in the first year of the new agreement period and performance in the 3rd year of the previous agreement period. For each qualifying measure, we would determine whether there was a significant improvement or decline between the two perf ormance years by applying a common standard statistical test. (See the discussion of the t- test for calculating the MA quality improvement

measure in “Medicare 2014 Part C & D Star Ra ting Technical Notes”, A ttachment I, page 80,CMS-1612-FC 916

which can be downloaded from the CMS website at http://www.cms.gov/Medicare/PrescriptionDrug-Coverage/PrescriptionDr ugCovGenIn/PerformanceData.html ). Statistical significance testing in this case assesses how unlikely it is that differences as big as those observed would be due to chance when the performance is actually th e same. The test recognizes and appropriately adjusts measures at both high and low levels of performance for stat istically significant levels of change. Under this methodology, we can be re asonably certain, at a 95 percent level of confidence, that statistically si gnificant differences in an ACO’ s quality measure performance for a year compared to the previous year are real and not simply due to random variation in measure sampling. The awarding of bonus points would be ba sed on an ACO’s net improvement within a domain, and would be calculated by determini ng the total number of significantly improved measures and subtracting the total number of significantly declined measures. Up to 2 bonus points would be awarded on a s liding scale based on the ACO’s net improvement for the domain compared to the total number of individual measures in the domain. Consistent with our current quality methodol ogy, the total points earned for measures in each domain, including any quality improvement points, would be summed and divided by the total points available for that domain to produce an overall domain score of the percentage of points earned versus points available. The perc entage score for each domain will be averaged together to generate a final overall quality perfor mance score and sharing rate for each ACO that

will be used to determine the amount of shared savings or, if applicable the amount of losses it owes, consistent with the requirements under §425.502(e). In developing this proposal to awar d bonus points for quality improvement, we considered several alternative options. Specifica lly, we considered whether it would be more appropriate not to award bonus poi nts but instead to include a computed quality improvementCMS-1612-FC 917

measure that would be incorporated into th e current scoring methodology just as any other

measure would be added. Under this alternativ e approach, we would in crease the total possible points that could be awarded in a domain. Howe ver, we did not propose that approach because we believe that awarding bonus points would provide the desi red incentive, would be more understandable and less disruptive, and would not require extensive ch anges to the quality performance standard. By awar ding bonus points we also avoid th e need to develop ways to avoid unfairly penalizing new ACOs . Similarly, ACOs that have already achieved a very high level of quality for an individual measure may not be able to achieve further statistically significant improvement for the measure. Such AC Os could otherwise be disadvantaged if they were not able to earn performance points for a new quality improvement measure added to the total measures in the domain. We believe our quality improvement proposal mitigates these concerns because the measure recognizes in cremental improvement at higher levels of performance and does not impose any penalty on AC Os that have already achieved a high level of performance. We also considered whether we should provi de an even greater additional incentive by increasing the total possible bonus points, perhaps up to 4 points to provide a higher incentive for greater levels of quality improvement. Howeve r, we did not propose that option because we were concerned that awarding 4 points for the quality improvement measure could overweight the additional incentive for quality improvement given that the program already rewards higher performance with a greater share of any savings. In addition, we had some concerns about whet her it would be appropria te to use the “pay for reporting” data reported to us , given that this information doe s not affect an ACO’s quality performance score in the first performance year. Therefore, we consider ed whether the quality improvement score should apply only to those ACOs that have completed at least twoCMS-1612-FC 918

performance years. Under this alternative approach, ACOs w ould have an opportunity to be assessed based on their actual quality measur e performance before being assessed on their quality improvement scores. We did not select th is approach because we wanted to provide an incentive that would apply as soon as possible in the agreement period. Furthermore, as noted earlier, we believe it would be a ppropriate to include pay-for-repor ting measures for purposes of awarding bonus points since under §425.500(f) ACOs are required to report pay-for-reporting measures completely, accurately, and timely. We proposed to add a new paragraph (e)(4) to §425.502 to incorporate this process for calculating bonus points for quality improvement into the quality performance scoring methodology. We solicited comments on this proposal and welcomed comments on the alternative approaches discusse d in the proposed rule. We al so solicited comments on whether there are other alternative approaches to expl icitly rewarding quality improvement for ACOs, and whether the implicit reward for quality im provement provided under the current regulations

is sufficient. We also welcomed any suggestions on how the Shared Savings Program might integrate elements of other quality improvement methodologi es such as those employed by HVBP or MA.

Such comments would be considered in develo ping possible future proposals to further align with other Medicare qual ity improvement programs. Comment: Commenters were supportive of e xplicitly recognizing and rewarding ACOs that make year to year improvements in the manner proposed. Many commenters, however, felt that our proposal did not go far enough and recommended instead that CMS award up to four bonus points (rather than two) for quality impr ovement in each of the existing four quality measure domains, or permit bonus points in one domain to influence the weighting of the domain. These commenters pointed out that th e proposal to award up to two bonus points wouldCMS-1612-FC 919

increase the overall quality performance score for an ACO by at most 14 percent. Some commenters suggested additional approaches, su ch as awarding an additional 10 percent of shared savings for those ACOs that score in the top 10 percent on qual ity measures. Another example is a suggestion that ACOs be allowed to retain 50% of their shar e of savings regardless of the MSR if their overall quali ty score improves year-over-year. Response: We appreciate the overall support from commenters who generally agreed with the proposal to offer an additional and ex plicit reward for improving quality performance in the Shared Savings Program. This additional reward would complement and reinforce our current quality performance scoring system that implicitly takes into account improvements over prior performance and rewards ACOs with a greater share in savings for greater quality performance. We believe that adding an e xplicit incentive places even greater emphasis on quality improvement, encouraging all ACOs to c ontinue to improve quality for their patient populations over time, in addition to maintaining existing high quality levels. The success of the Shared Savings Program is dependent in large part on ACOs further improving the quality of the care they provide, not merely mainta ining current levels of quality. Further, we believe that the suggestions from some commenters to increase the additional quality improvement award to up to four bonus points have merit. Although we proposed the improvement measure to increase the domain score by up to 2 points, similar to other measures in the domain, we agree with commenters that increasing this to four bonus points would not appe ar to overweight the additional incentive since the additional bonus points can only increase a quality score by at most 25 percent overall. (That is, 4 bonus points per domain times 4 domains equals 16, which when divided by the 66 total points possible equals appr oximately 25 percent). Additionally, we have at least one measure (ACO #11, Percent of PCPs who Successfully Qualify for an EHR Incentive Program Payment) that is doubly weighted at 4 points in order to emphasize the importance ofCMS-1612-FC 920

adoption of EHR meaningful use. Permitting the quality improvement measure to be double weighted would similarly emphasize the im portance of quality improvement, further encouraging ACOs to improve overall quality for their patient populations over time. Final Decision: We are finalizing our pr oposal to provide an additional quality improvement reward for Shared Savings Program ACOs who demonstrate quality improvement

on measures in a domain. We believe that th is additional and explicit reward for quality improvement would complement and reinforce our current quality performance approach. Specifically, for each quality measure domain, we will award an ACO up to four additional bonus points for quality performance improvement on the quality measures within the domain. These bonus points would be added to the total po ints that the ACO achie ves within each of the four domains. The total possibl e points that can be achieved in a domain, including up to 4 bonus points, could not exceed the maximum tota l points achievable within the domain. For example, as shown in Table 82, the total possibl e points for the patient/caregiver experience domain, which has eight individual measures, is 16 total possible points. Under this new policy that we are finalizing to provi de for quality improvement bonus points, the maximum possible points within this domain will remain 16. If an ACO scores 12 points and is awarded four additional bonus points for quality improvement th en the ACO’s total points for this domain would be 16. However, if instead this same AC O had scored 13 points, then this ACO’s total points after adding the bonus points would stil l not exceed 16. Table 82, which shows the number of points available per domain under the revised quality performa nce standard, reflects the current quality measure scoring methodology which will continue. Consistent with our current quality scoring methodology, the total points earned for measures in each domain, including any quality improvement bonus points up to the total po ssible points for the domain, would be summed and divided by the total points av ailable for that domain to produce an overallCMS-1612-FC 921

domain score of the percentage of points earned versus points av ailable. The percentage score for each domain will be averaged together to generate a final overall quality performance score and sharing rate for each ACO that will be used to determine the percentage of savings it shares or, if applicable, the percentage of losses it owes, consistent with the methodology established under §425.502(e). The calculation of the quality improvement measure for each domain would generally be

based on the formula used for the MA five star rating program, as follows: Improvement Change Score = score for a measure in performance year minus score in previous performance year. For each qualifying measure, we will determine whether there was a significant improvement or decline between the two performance years by a pplying a “t-test” which is a common standard statistical test, at a 95 percent level of confiden ce. (See the discussion of the ttest for calculating the MA quality improvement measure in “Medicare 2014 Part C & D Star Rating Technical Notes”, Attachment I, page 80, which can be downloaded from the CMS

website at http://www.cms.gov/Medicare/Prescription-DrugCoverage/PrescriptionDrugC ovGenIn/PerformanceData.html ). This test assesses how unlikely it is that differences as big as those observed w ould be due to chance when the performance is actually the same. The bonus points, up to a maximum of 4 point s, will be awarded in direct proportion to the ACO’s net improvement for the domain to th e total number of individual measures in the domain. For example, there are eight individual measures for the patient/caregiver experience of care domain. If an ACO achieves a significant qual ity increase in all eight measures then the

ACO would be awarded the maximum of four bonus points for this domain. However, if the ACO achieved a significant quality increase in only one of the eight measures in this domain andCMS-1612-FC 922

no significant quality decline on any of the m easures then the ACO would be awarded bonus points for quality improvement in the domain that is 1/8 times 4 = 0.50. The total points that the

ACO could achieve in this domain could sti ll not exceed the current maximum of 16 points shown in Table 82. We are also finalizing our proposal to add a new paragraph (4) to §425.502(e) to incorporate the new bonus point s scoring methodology, but are revising the proposed language in order to reflect our decisi on to award up to 4 bonus points per domain.

7. Technical Corrections Currently §425.502(d)(2)(ii) stat es that ACOs must score above the minimum attainment level determined by CMS on 70 percent of the meas ures in each domain. If an ACO fails to

achieve the minimum attainment level on at leas t 70 percent of the meas ures in a domain, CMS will take the actions described in §425.216(c). We note that §425.216, which addresses the actions we may take prior to termination of an ACO from the Shared Savings Program does not include a paragraph (c). To en compass all of the actions we may take prior to termination, we believe the correct reference should be to §425.216 generally, and therefore, proposed to make a technical correction to § 425.502(d)(2)(ii) to eliminate the specif ic reference to paragraph (c) of §425.216. We also proposed to correct a typogr aphical error in this provision by revising

“actions describe” to read “actions described.” In addition, we also proposed to make a technical correction to §425.502(a)(2). This provision currently states that ACOs will be assessed on performance based on the minimum

attainment level for certain measures. Howeve r, as explained above and in the November 2011 Shared Savings Program final rule (76 FR 67895 through 67896), ACO performance on a measure is assessed not only based on the minimu m attainment level for the measure but also based upon the quality performance benchmark that ha s been established for that measure. This methodology for calculating the performance score for a measure is codified in the regulations atCMS-1612-FC 923

§425.502(c). Accordingly, we proposed to amend §425.502(a)(2) to state that ACO performance will be assessed based on the quality performance benchmark and minimum attainment level for

certain measures. We requested comments on these proposed techni cal corrections. We received no objections to correcting th e typographical errors and making these

other minor technical corrections an d are finalizing them as proposed.CMS-1612-FC 924

N. Value-Based Payment Modifier and Physician Feedback Program

1. Overview Section 1848(p) of the Act requires that we establish a value-based payment modifier (VM) and apply it to specific phys icians and groups of physicia ns the Secretary determines appropriate starting January 1, 2015, and to all physicians and groups of physicians by January 1, 2017. On or after January 1, 2017, section 1848(p )(7) of the Act provides the Secretary discretion to apply the VM to el igible professionals as defined in section 1848(k)(3)(B) of the Act. Section 1848(p)(4)(C) of the Act requires the VM to be budget neutral. The VM program continues CMS’s initiative to increase the transpar ency of health care qua lity information and to assist providers and benefici aries in improving medical deci sion-making and health care delivery. 13 2. Governing Principles for VM Implementation.

In the CY 2013 PFS final rule with comment period, we discussed the goals of the VM and also established that specifi c principles should govern the implementation of the VM (77 FR 69307). We refer readers to that rule for a detail ed discussion and list t hose principles here for

reference.

● A focus on measurement and alignment. Measures for the VM should consistently reflect differences in performance among groups or solo practitioners, refl ect the diversity of services furnished, and be consistent with th e National and CMS Qualit y Strategies and other CMS quality initiatives, includ ing the PQRS, the Shared Savi ngs Program, and the Medicare EHR Incentive Program.

13 Kate Goodrich, et al. “A History and a Vision fo r CMS Quality Measurement Programs”. Joint Comm’n J. Quality & Patient Safety. 2012. 38,465, available at http://www.ingentaconnect.com/content/jcaho/jcjqs/2012/00000038/00000010/art00006.CMS-1612-FC 925

● A focus on physician and eligible prof essional choice. Physicians and other nonphysician eligible professionals should be able to choose the level (ind ividual or group) at which their quality performance will be assessed, reflecting eligible professionals’ choice over their practice configurations. The choice of level should align with the requirements of other physician quality reporting programs.

● A focus on shared accountability. The VM can facilitate shared accountability by assessing performance at the gr oup level and by focusing on the tota l costs of care, not just the costs of care furnished by an individual professional.

● A focus on actionable information. Th e Quality and Resource Use Reports (QRURs) should provide meaningful and actionable inform ation to help groups and solo practitioners identify clinical, efficiency and effectiveness ar eas where they are doing well, as well as areas in which performance could be improved by providi ng groups and solo practitioners with QRURs on the quality and cost of care they furnish to their patients.

● A focus on a gradual implementation. Th e VM should focus initially on identifying high and low performing groups and solo practiti oners. As we gain more experience with physician measurement tools and methodologies, we can broaden the scope of measures assessed, refine physician peer groups, create fi ner payment distinctions , and provide greater payment incentives for high performance. 3. Overview of Existing Policies for the Physician VM.

In the CY 2013 PFS final rule with comment period (77 FR 69310), we finalized policies to phase-in the VM by applying it beginning January 1, 2015, to Medicare PFS payments to physicians in groups of 100 or more eligible pr ofessionals. A summary of the existing policies

that we finalized for the CY 2015 VM can be found in the CY 2014 PFS proposed rule (78 FR 43486 through 43488). Subsequently, in the CY 2014 PFS final rule with comment period (78CMS-1612-FC 926

FR 74765 through 74787), we finalized policies to c ontinue the phase-in of the VM by applying it starting January 1, 2016 to paym ents under the Medicare PFS for physicians in groups of 10 or more eligible professionals.

4. Provisions of This Final Ru le With Comment Period As a general summary, we proposed the following VM policies in the CY 2015 PFS proposed rule:

● To apply the VM to all physicians and nonphysician eligible prof essionals in groups with two or more eligible pr ofessionals and to solo prac titioners starting in CY 2017.

● To make quality–tiering mandatory for gr oups and solo practiti oners within Category 1 for the CY 2017 VM. Where solo practitione rs and groups with tw o to nine eligible professionals would be subject only to any upw ard or neutral adjustment determined under the quality-tiering methodology.

● To tailor the application of the VM to physicians and nonphysician eligible professionals participating in the Medicare Shared Savings Progr am (Shared Savings Program), the Pioneer ACO Model, the CPC Initiative, or other similar Innovation Ce nter models or CMS initiatives starting in CY 2017.

● To clarify the exclusion of non-assigned claims for non-participating providers from

the VM.

● To increase the amount of payment at risk under the VM from 2.0 percent in CY 2016 to 4.0 percent in CY 2017.

● To align the quality measur es and quality reporting mechan isms for the VM with those available to groups and individuals under th e PQRS during the CY 2015 performance period.

● To expand the current informal inquiry process to allow additional corrections for the CY 2015 payment adjustment period.CMS-1612-FC 927

● To address the concerns ra ised by NQF regarding the per ca pita cost measures in the cost composite. In this final rule with comment period, we discuss the proposed policies, the comments received, our responses to the comments, a nd a brief statement of our final policy.

Comment: We received some comments on the VM in general that were not related to any specific proposal that we made in the proposed rule. Several commenters suggested that the CMS- hierarchical condition categories (HCC) Ri sk Adjustment methodology used in the total per capita cost measures for the VM does not accu rately capture the additional costs associated with treating the sickest beneficiaries. Some of these commenters stated that groups that work exclusively in post-acute and l ong-term care settings would be unable to perform well on cost measures under the current methodology. Comment ers suggested that we should include the place of service where the beneficiary received care in our methodology to set cost benchmarks such that groups would be compared against othe r groups that treat bene ficiaries who are also receiving care in that type of location. Another commenter suggested that we add an additional adjustment for SNF CPT codes to account for higher costs of bene ficiaries in this location. On e commenter suggested that CMS exclude beneficiaries who receive a major organ transplant from our cost and quality measures because he believes that prospective HCC risk adjustment would not account for these added costs in the performance period. Another commenter stated that benefici aries who receive care at home typically have high HCC scores and higher costs. This commenter suggested that CMS should consider exempting practices from the VM who treat a high number of beneficiaries with the highest HCC scores or those with more th an a certain number of chronic conditions or activities of daily living depende ncies, change the risk adjust ment methodology to include the frailty adjuster used in the PACE program, or add “recognition of savings from expected costs.”CMS-1612-FC 928

Response: We appreciate the concerns rais ed by commenters and agree that it is important to make adjustments for differences in beneficiary characteristic s that impact health

and cost outcomes and are outside of the control of the provider. We continue to believe that our current methodology of using HCC scores that in clude adjustments for Me dicare and Medicaid eligibility status in addition to diag noses, and truncating costs at the 99 th percentile for the highest cost beneficiaries, help address these concerns. While, the VM program does not, in the aggregate, adjust costs using an institutional ri sk score, the Medicare Spending per Beneficiary measure that will be used as part of the cost composite in 2014 does adjust costs based on whether a beneficiary recently required long-term institutional care as well as for whether a beneficiary is new to the Medicare program. We addressed the idea of adjusting cost measures for differences in site of service, as it pertai ned to hospitals, in the FY 2012 IPPS Final Rule (76 FR 51825). We continue to believe that such adjustments would undermine the ability of our measures to meaningfully capture differences in Medicare spending. To address concerns regarding specialties th at might routinely treat more complex and consequently more costly beneficiaries, we finalized in the CY 2013 PFS fi nal rule with comment period that we would apply a specialty adjustment to all cost measur es used in the VM (78 FR 74776). This enables groups’ costs to be compared to similarly-comprised groups, based on specialty. In 2011, an independent analysis concluded that this risk-adjustment met hodology is effective at predicting actual costs, even for beneficiaries w ith serious or multiple chronic illnesses. 14 Moreover, the

academic literature notes the multi-variant nature of care quality and the importance of defining

measures across rather than si mply within care settings. 15

14 Gregory C. Pope, et al. “Evaluation of the CMS-HCC Risk Adjustment Model: Final Report.” (March 2011). 15 Tracy E. Spinks, et al. Delivering high-quality cancer ca re: The critical role of quality measurement. Healthcare. 2014. 2,53-62.CMS-1612-FC 929

We note that high costs within the post-acute and l ong-term care settings present a unique opportunity for these providers to improve perfor mance on cost and quality measures. While we continue to encourage providers to report quality measures for pati ents in these settings and to use the information contained in their QRUR to im prove and achieve high levels of performance, we will continue to monitor these groups and solo practitioners’ performance under the VM and continue to explore potential risk adjustment refinements.. a. Group Size As noted in section III.N.1, s ection 1848(p)(4)(B)(iii )(II) of the Act requires the Secretary to apply the VM to items and services furnis hed under the PFS beginning not later than January 1, 2017, for all physicians and groups of physicians. Therefore, we proposed to apply the VM in CY 2017 and each subsequent calendar year paym ent adjustment period to physicians in groups of physicians with two or more eligible pr ofessionals and to phys icians who are solo practitioners (79 FR 40493-40495). For purposes of the VM, we defined a physician, a group of physicians, and an eligible professional in the CY 2013 PFS final rule with comment period (77 FR 69307-69310). We proposed to define a “sol o practitioner” at §414.1205 as a single Tax Identification Number (TIN) with one eligible professional who is identified by an individual National Provider Identifier (NPI ) billing under that TIN. We not ed that this proposal to apply the VM to all solo practitione r physicians and all groups of physicians would complete our phase-in of the VM as required by the Act. In the proposed rule, we stated our belief that we can validly and reliably apply the VM to groups with two or more elig ible professionals and to solo practitioners (79 FR 40494). We

noted that we conducted statistica l reliability analysis on the PQ RS quality measures and the VM cost measures reported in the 2010 and 2011 gr oup and individual Quality and Resource Use Reports (QRURs) (78 FR 43500 through 43502) and found that 98 percent of the PQRSCMS-1612-FC 930

measures included in the analysis, which were s ubstantially similar to the PQRS measures that will be assessed during performance period CY 2015 for purposes of the VM, were highly reliable. As stated in the proposed rule, we believe that these resu lts suggest that we can reliably apply these measures to solo practitioners a nd groups (79 FR 40494). In section III.N.4.h, we discuss the reliability of the all-cause readmissi on measure and the policy we are finalizing to address reliability concerns regarding that measure. In Table 55 of the proposed rule, we pr esented the number of groups, eligible professionals, physicians, and nonphysician eligible professionals in groups of various sizes based on an analysis of CY 2012 claims with a 90-day run-out period (79 FR 40494). We estimated that our proposals to apply the VM to all groups with two or more eligible professionals and to all solo practitioners in CY 2017 would affect approximately 83,500 groups and 210,000 solo practitioners (as id entified by their TINs). We further estimated that the groups consist of approximately 815,000 physicians a nd 315,000 nonphysician eligible professionals (79 FR 40493). For this final rule with comment period, we have updated Table 55 from the proposed rule, using CY 2013 claims with a 90-day clai m run-out period and including TINs that participated in the Shared Savings Program, the Pioneer ACO Model, or the Comprehensive Primary Care Initiative in 2013. Table 86 shows the number of groups, eligible professionals, physicians, and nonphysician eligible professionals in groups of various sizes. We note that the number of eligible professionals includes other practitioners, su ch as physician assistants and nurse practitioners, in addition to physicians. We estimate that final policy to apply the VM to all physicians in groups with two or more eligible professional s and to all physicians who are solo practitioners in CY 2017 would affect approximately 900,000 physicians.CMS-1612-FC 931

TABLE 86: Eligible Professional/Physici an Group Size Distribution (2013 claims)

Group Size Number of Groups (TINs)* Eligible Professionals (EPs) Number of Physicians Number of Nonphysician EPs Percent of Physicians Percent of Nonphysician EPs 100+ EPs 1,345 404,738 297,175 107,563 33% 30% 50-99EPs 1,753 119,979 81,679 38,300 9% 11% 25-49 EPs 3,926 134,038 90,141 43,897 10% 12% 20-24 EPs 1,957 42,733 29,112 13,621 3% 4% 10-19 EPs 8,697 117,164 78,893 38,271 9% 11% 2-9 EPs 69,455 244,800 171,627 73,173 19% 20 1 EP 205,084 205,084 159,770 45,314 18% 13 Total 292,217 1,268,536 908,397 360,139 100% 100% *The number of groups (TINs) include TINs that have one or more EPs participating in the Shared Savings Program, the Pioneer ACO Model, or the Co mprehensive Primary Care Initiative.

In the proposed rule (79 FR 40494), we stated that in the CY 2014 PFS final rule with comment period, we finalized the pr oposal that if we are unable to attribute a sufficient number of beneficiaries to a group of physicians subject to the VM, and thus, are unable to calculate any

of the cost measures with at least 20 cases, then the group’s cost composite score would be classified as ‘‘average’’ under the qualit y-tiering methodology ( 78 FR 74780 through 74781). However, we noted this policy was codified in § 414.1270(b)(5) as a group of physicians subject to the value-based payment modifier will receive a cost composite score that is classified as ‘‘average’’ under §414.1275( b)(2) if such group does not have at least one cost measure with at

least 20 cases. We stated that we believe the regulation text at §414.1270(b)(5) better reflects the intent of this policy, and accordingly, we proposed to clarify that the description of this policy in the preamble of the CY 2014 PFS final rule with comment period (78 FR 74780 through 74781) should be the same as the regulation text at §414.1270(b)(5). We also proposed to apply the same policy to groups and solo practitioners beginning in CY 2017. That is, a group or soloCMS-1612-FC 932

practitioner would receive a cost composite score that is classified as ‘‘average’’ under the quality-tiering methodology if the group or solo practitioner does not have at least one cost

measure with at least 20 cases. We proposed to revise § 414.1270 accordingly. We proposed to revise §414.1210 to reflect that beginning in the CY 2017 payment adjustment period, the VM would be appl ied to physician and nonphysician eligible professionals in groups with two or more eligible professionals and to solo practitioners based on the performance period described at §414.1215 (79 FR 40495). Accordingly, we proposed to amend the regulations under subpart N to add re ferences to solo practitioners. We solicited comments on all of these proposals. The following is summary of the comme nts we received on these proposals.

Comment: We received one comment that s upported our proposed definition of a “solo practitioner.” Response: We appreciate this comment and are finalizing the definition of a “solo practitioner” to mean, “a singl e Taxpayer Identification Numb er (TIN) with one eligible professional who is identified by an individual National Provider Identifier (NPI) billing under the TIN.” We are codifyi ng this definition at §414.1205. Comment: Several commenters expressed conc ern that the cost measures potentially have little relevance to some provider groups an d may leave some with an arbitrary label of “average” cost, if the minimum case number requirement for the cost measure is not met due to

an insufficient number of beneficiarie s being attributed to the group. Response: As we stated in the CY 2014 PFS final rule with comment period (78 FR 74780), we continue to believe that groups that are attributed fewer than the minimum

case size of 20 beneficiaries would not allow for th e calculation of reliable cost measures. We are concerned that not classify ing the group as “average” when it has fewer than 20 attributedCMS-1612-FC 933

beneficiaries for at least one cost measure would increase the lik elihood that its cost measures could fluctuate greatly from year to year. Therefore, we are finalizing our proposal that beginning in CY 2017 a group or solo practitione r will receive a cost co mposite score that is classified as “average” under the quality-tieri ng methodology if the group or solo practitioner

does not have at least one cost measure with at least 20 cases and c odifying the policy as proposed in §414.1270. We are also fi nalizing our proposal to clarify that the de scription of this policy in the preamble of the CY 2014 PFS fina l rule with comment period (78 FR 74780 through 74781) for groups of physicians should be the same as the regulation text at §414.1270(b)(5). Comment: Several commenters, citing the S ecretary’s statutory ob ligation, supported our proposal to apply the VM in the CY 2017 paym ent adjustment year to solo practitioner physicians and to groups of physicians with tw o or more eligible professionals. Other commenters opposed our proposed policy notwithsta nding the statutory oblig ation to apply the VM to all physicians and groups of physicia ns beginning not later than January 1, 2017.

Commenters stated that we s hould delay the application of th e VM to all physicians, either through selective implementation or requesting that Congress amend the statute. Some commenters stated that, due to provider resource constraints, lack of acce ss to adequate technical support, and potential lack of understanding of the information provided through the Physician Feedback Program, we should postpone the extens ion of the VM to smaller group practices and solo practitioners. Some commenters sugge sted that the VM would negatively impact physicians, especially given the pr oposed increase in the amount of payment at risk for CY 2017. Response: We disagree th at the VM’s application to smaller groups and solo practitioners should be delayed. In addition to the statutory requi rement to apply the VM to all physicians and groups of physicians beginning not later than January 1, 2 017, the application ofCMS-1612-FC 934

the VM to all physician groups and solo practitio ners is essential to our ongoing efforts to encourage improvement in the quality and efficien cy of care provided to Medicare beneficiaries and should not be delayed. The literature highlights that the majority of pa tients receive care in group practices with one or two physicians 16 and that historically, smaller group practices have participated in quality improvement programs at lower rates than larger group practices. 17

Recent research also concludes that EHR-enable d small practices responded to incentives to improve quality of care on process and intermediate-outcome measures. 18 For these reasons, we believe that the application of the VM to sma ller group practices and solo practitioners has the potential to incentivize increased participation in quality repo rting and quality improvement activities and that smaller groups and solo practitioners have th e potential to perform well under

the VM. The application of the VM to groups of two to nine eligible professionals and to solo practitioners in CY 2017 is consistent with our principle to focus on a gradual implementation of the VM. The financial impact of applying the VM to groups of two to nine eligible professionals and to solo practitioners will be eased since, we are finalizing a policy to hold them harmless from any downward payment adjustments under quality-tiering in CY 2017 (as discussed in section III.N.4.c.) and also finalizing a smalle r downward payment adjustment under the VM for these groups and solo practitioners that are in Category 2 in CY 2017 (a s discussed in section III.N.4.f below). Please note that in section III.N.4.b of this fina l rule with comment period, we are finalizing that the VM will apply to nonphysicia n eligible professionals in groups subject to the VM and to nonphysician eligible professionals who are solo pr actitioners begi nning in the

16 Sowmya R Rao, et al. Electronic health records in small physician practices: availability, use, and perceived benefits. J. Am. Med. Information Ass’n. 2011. 18, 271-275. 17 Anne-Marie J. Audet, et al. Measure, Learn, And Improve: Physicians’ Involvement in Quality Improvement. Health Affairs. 2005. 24,843-853. 18 Naomi S. Bardach, et al., Effect of Pay-for-Performance Incentives on Qua lity of Care in Small Practices With Electronic Health Records. J. Amer. Med. Ass’n. 2013. 310,1051-1059.CMS-1612-FC 935

CY 2018 payment adjustment period.

Comment: Several commenters stated that CM S should ensure that the quality and cost measures are reliable and valid for small practic es and solo practitioners before expanding the VM to all physicians. Response: Since the inception of the VM program, we have committed to establish a payment modifier that relies on a focused core set of measures appropr iate to each specific provider category that reflects th e level of care and the most important areas of service and measures for that provider (77 FR 69306). An alysis of the Physician Feedback Program

confirms that the measures on which the VM is ba sed are highly reliable, especially those that are self-reported. 19 As stated in the proposed rule ( 79 FR 40494), we will be basing the quality of care composite on the PQRS m easures selected, and reported on, by the groups (or the eligible professionals in the groups) and the solo prac titioners, which enables us to recognize the diversity of reporting options for individuals and groups under the PQRS program and provide flexibility on the data they report for quality me asures under the PQRS. Th is also allows these groups and solo practitioners the opp ortunity to choose measures that are relevant to their patient populations and consistent with c linical practice and high quality car e. Moreover, our policy will mitigate any unintended consequences of the VM payment adjustment on smaller groups by holding harmless solo practitioner p hysicians and physicians in groups with two to nine eligible professionals from any downward payment ad justments under quality-tiering in CY 2017 (see

section III.N.4.c of this final rule with comment period). We conducted an additional analysis of the co st measures for the VM, using our specialty benchmarking methodology and found the per capita cost measures to be reliable for solo

19 Mathematica Policy Research, Experience Report for th e Performance Year 2012 Quality and Resource Use Reports (January 8, 2014), available at http://www.cms.gov/Medi care/Medicare-Fee-for-ServicePayment/PhysicianFeedbackProgram/Downlo ads/2012-QRUR_Experience_Report.pdf.CMS-1612-FC 936

practitioners and groups of two or more eligible professionals. That analysis may be found at: https://www.cms.gov/Medicare/M edicare-Fee-for-ServicePayment/PhysicianFeedbackProgram/Val ueBasedPaymentModifier.html.

Comment: Some commenters e xpressed concern about the VM’s impact on providers who treat high-cost patients and on certain spec ialties, such as anesthesiology, for which few quality measures are available. Response: The VM program continues to be lieve in the importance of stakeholder engagement for establishing quality metrics. To that end, we engage th e National Quality Forum to pursue national endorsement of measures us ed in PQRS and the VM program. We are committed to using PQRS as the foundation for m easurement of the performance rates for solo practitioner physicians and groups of physicians subject to the VM (77 FR 69314). Moreover, we recognized early in the VM program that the PQRS may not provide specialists and subspecialists the flexibility to report on measures th at are relevant to their unique patient panels. As discussed later, in section III.N.4.h, in previous rulemakings, we have committed to expanding the specialty measures available in the PQRS in order to more accurately measure the performance on quality of care furnished by specia lists. We also reaffirm our commitment to using measures of performance across specialties that are reliable and valid for the VM program (77 FR 69315; 78 FR 74773).

Physicians have sufficient flexibility to choose the quality reporting method–PQRS GPRO web-interface, claims, regi stries, qualified clinical data registries, and EHR reporting mechanisms, as well as the measures on which to report information. The expansion of the GPRO to registries in 2013 and to EHRs in 2014 allowed sub-specialists to participate in PQRS as members of a group practice, such that the group could repo rt data on measures of broad applicability (77 FR 69315). The claims-based out come measures used in the VM afford groupsCMS-1612-FC 937

and solo practitioners an additional opportunity to earn a quality composite score that is above average. Where a group or solo practitioner fa lls in Category 1 under the VM (that is, meets the criteria to avoid the CY 2017 PQ RS payment adjustment), but the group or solo practitioner does not have at least 20 cases for each PQRS measure on which it reports as re quired for inclusion in the quality composite of the VM, the group or so lo practitioner’s quality composite score would

be based on the three claims-based outcome me asures described at §414.1230, provided that the group or solo practitioner has at least 20 cases for at least one of th e claims-based outcome

measures. In addition, as discussed in section III.N.4.h of this final rule with comment period, eligible professionals and groups should note that PQRS has a Measure Applicability Validation (MAV) process. MAV determines PQRS incentive eligibility or potential applicability of the payment adjustment for eligible professionals and groups reporting less than nine measures

across three domains or nine or more across less than three domains. We recommend that commenters refer to the Measure Application Va lidation (MAV) Process to alleviate concerns that lack of applicable measures would resu lt in an automatic downw ard adjustment under the

VM . http://www.cms.gov/Medicare/Qualit y-Initiatives-Pa tient-AssessmentInstruments/PQRS/Downloads/2014_PQRS_ Claims_MeasureAppli cabilityValidation_12132013 .zip. Also, please refer to secti on III.K.2 of this final rule w ith comment period for the final 2017 policies for MAV and the criteria for satis factory reporting for the 2017 PQRS payment adjustment. Comment: Commenters cited that solo practi tioners and groups with 2 to 24 eligible professionals, who received a QRUR in fall 2014, will have a short period of time to analyze their performance data and to prep are for the CY 2015 performance period. Response: On September 30, 2014, we ma de Quality and Resource Use ReportsCMS-1612-FC 938

(QRURs) available to all group of physicians and physicians who are solo practitioners based on their performance in CY 2013. As we stated in the CY 2015 proposed rule (79 FR 40494-95), we believe that we have provi ded small groups and solo practitioners sufficient time to understand how the VM works and how to participat e in the PQRS. We ar e sensitive to groups and solo practitioners who may need adequate lead time to understa nd the impact of the beneficiary attribution method used for the VM. At the time that we made our proposal to apply the VM to solo practitioners a nd groups of 2 to 25 EPs, availa ble research suggested that the information provided in the QRURs is relevant to solo practitione rs and groups for future quality improvement efforts. Published lite rature suggests that, of the bene ficiaries assigned in one year to a group practice under the Shared Savings Prog ram attribution rule, wh ich is substantially similar to the one used in the VM program – 80 percent were assigne d to that same group practice the following year. 20 In response to commenters’ concerns, we also conducted an additional analysis using the VM attribut ion methodology and determined that, of the beneficiaries assigned to a given TIN for the five cost and 3 outcome measures included in the VM for 2017, approximately 76% were assigned to the same TIN for these measures, in both

2012 and 2013. More importantly, we believe our final polic y to hold harmless groups with two to nine eligible professionals and so lo practitioners from any downward payment adjustments under quality-tiering in CY 2017 would lik ely mitigate unintended consequences that could occur (see section III.N.4.c of this final rule). We not e that in the 2013 QRUR Experience Report, which will be released in the next few months, we will provide a detailed analysis of the impact of the 2015 VM policies on groups of 100 or more eligib le professionals subjec t to the VM in CY

20 J. Michael McWilliams, et al. Outpatient Care Pattern s and Organizational Accountability in Medicare. 2014. 174,938-945.CMS-1612-FC 939

2015, including findings based on the data cont ained in the 2013 QRURs for all groups of physicians and solo practitioners.

Comment: Several commenters believed that physicians had have li ttle experience with the PQRS program and physicians generall y do not understand the methodology used to calculate the VM and therefore urged CMS to in crease its outreach and education efforts. One commenter urged CMS to publicly share the VM methodology, as well as the results of the reliability and validity testing of the measur es used in the calculation of the VM. Response: In response to the comments about physicians not being familiar with the PQRS program or not understanding the methodol ogy used to calculate the VM, we strongly encourage physicians to proactively educate themselves about the PQRS and VM programs by visiting the PQRS website http://www.cms .gov/Medicare/Quality-In itiatives-PatientAssessment-Instruments/PQRS/index.html and VM/QRUR websitehttp://www.cms.gov/Medicare/Medicare-Fee-for-ServicePayment/PhysicianFeedbackProgram/index.html. The PQRS website contains detailed information about how groups and individual eligible pr ofessionals can participate in the PQRS program, including information on how to avoid the PQRS payment adjustment. The VM/QRUR website (https://www.cms.gov/Me dicare/Medicare-Fee-for-ServicePayment/PhysicianFeedbackProgram/index.html) cont ains information on the VM policies for each applicable payment adjustment year, including detailed information on the methodology

used to calculate the CY 2015 VM shown in the CY 2013 QRURs and how to use the information contained in the QRURs. We not e that we work with medical and specialty associations throughout the year to educate th em about the PQRS and VM programs and the QRURs. Further outreach will be also be undert aken by our Quality Improvement Organizations (QIOs), who will provide technical assistance to p hysicians and groups of physicians in an effortCMS-1612-FC 940

to help them improve quality and conse quently, performance under the VM program. As we expand the application of the VM to all physicians, we will continue to monitor the VM program and continue to examine the char acteristic of those gr oups of physicians and solo practitioners that could be subject to an upward or downward payment adjustment under our quality-tiering methodology to determ ine whether our policies create anomalous effects in ways

that do not reflect consistent differences in performance among physicians and physician groups. After considering the public comments, we ar e finalizing the proposal and regulation text at §414.1210(a)(3) that, beginning with the CY 2017 payment adjustment period, the VM will apply to physicians in groups with two or more eligible professi onals and to physicians who are solo practitioners based on the performance pe riod described at §414.1215. We are finalizing the definition of a “solo practitioner” at §414.1205 a nd amending the regulations under subpart N to add references to solo practitioners. We are al so finalizing our proposal and the regulation text at § 414.1270(c)(5) that beginning in CY 2017 a gr oup or solo practitione r will receive a cost composite score that is classified as “average ” under the quality-tier ing methodology if the group or solo practitioner does not have at least one cost measure with at least 20 cases. We are also finalizing our proposal to clarify that the description of this po licy in the preamble of the CY 2014 PFS final rule with comment period (78 FR 74780 through 74781) for groups of physicians

should be the same as the re gulation text at §414.1270(b)(5). b. Application of the VM to Nonphysician EPs As noted above, section 1848(p) of the Act requ ires that we establish the VM and apply it

to items and services furnished under th e PFS 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. Section 1848(p)(7) of the Act provides the Secretary discretion to apply the VM on or after January 1, 2017 to eligibleCMS-1612-FC 941

professionals as defined in secti on 1848(k)(3)(B) of the Act. As previously finalized in the CY 2013 PFS final rule with comment period, in pa yment adjustment years CY 2015 and CY 2016, we will apply the VM to Medica re payments for items and services billed under the PFS by physicians in groups (as identified by their Medi care-enrolled TIN) subject to the VM, but not to the other eligible professionals that also may bill under the TIN (77 FR 69312). We finalized in the CY 2013 PFS final rule with comment period (77 FR 69307 through 69310) that physicians, as defined in section 1861(r) of the Act, include doctors of medicine or osteopathy, doctors of dental surgery or dental medi cine, doctors of podiatric medi cine, doctors of optometry, and chiropractors.

In section III.N.4.a of this final rule with comment period, we finalized our proposal to apply the VM in the CY 2017 payment adjustment period and each subsequent calendar year payment adjustment period to physicians in grou ps of physicians with two or more eligible professionals and to physicians who are so lo practitioners as required by section 1848(p)(4)(B)(iii)(II ) of the Act. In the CY 2015 PFS proposed rule, based on th e Secretary’s discre tion under section 1848(p)(7) of the Act, we proposed to apply the VM beginning in the CY 2017 payment adjustment period to all of the eligible professionals in groups with two or more eligible professionals and to eligible professionals w ho are solo practitioners (79 FR 40495-40496). That is, we proposed to apply the VM beginning in CY 2017 to the items and services billed under the PFS by all of the physicians and nonphysician elig ible professionals who bill under a group’s TIN. We proposed to apply the VM beginning in CY 2017 to groups th at consist only of nonphysician eligible professionals (for example, groups with only nurse practitioners or physician assistants). We also proposed to m odify the definition of “group of physicians” under §414.1205 to also include the term “group” to reflect these proposals. We also proposed to applyCMS-1612-FC 942

the VM beginning in CY 2017 to nonphysician eligible professionals who are solo practitioners. Additionally, we proposed that physicians and nonphysician eligible professionals would be subject to the same VM policie s established in earl ier rulemakings and under 42 CFR part 414, subpart N. For example, nonphysician eligible professionals would be subject to the same amount of payment at risk and quality-tiering poli cies as physicians. We proposed to modify the regulations under 42 CFR part 414, subpart N, accordingly. We finalized in the CY 2013 PFS final rule with comment period (77 FR 69307 through 69310) that, for purposes of establishing group size , we will use the definition of an eligible professional as specified in sec tion 1848(k)(3)(B) of the Act. Th is section defines an eligible professional as any of the following: (1) a phys ician; (2) a practitione r described in section 1842(b)(18)(C) of the Act: physician assistant, nu rse practitioner, clini cal nurse specialist, certified registered nurse anesthetist, certified nurse-midwife, clinical social worker, clinical psychologist, registered dietic ian, or nutrition prof essional; (3) a physic al or occupational therapist or a qualified speech-language path ologist; or (4) a qualified audiologist. Beginning CY 2017, under our proposal, the VM would apply to all of the eligible professionals, as specified in se ction 1848(k)(3)(B) of the Act, that bill under a group’s TIN based on the TIN’s performance during the appli cable performance period. During the payment adjustment period, all of the nonphysician eligible professionals who bill under a group’s TIN would be subject to the same VM that would appl y to the physicians who bill under that TIN. This proposal was consistent with our stat ed principle that the VM should focus on shared accountability (77 FR 69307). We continue to believe that the VM can facilitate shared accountability by assessing performance at the gr oup practice level and by focusing on the total costs of care, not just the costs of car e furnished by an individual physician.CMS-1612-FC 943

Moreover, section 1848(p)(5) of the Act requires us to, as ap propriate, apply the VM “in a manner that promotes systems-based care.” We stated in the CY 2013 PFS proposed rule that, in this context, systems-based care is the proces ses and workflows that (1 ) make effective use of information technologies, (2) develop effectiv e teams, (3) coordinate care across patient conditions, services, and settings over time, and (4) incorporate performance and outcome measurements for improvement and accountability. 21 (77 FR 44996) We stated in the CY 2015 PFS proposed rule, we believe that applying the VM to all of the eligible professionals in a group, rather than only the physicians in th e group, would enhance the group’s ability and resources to redesign processe s and workflows to achieve th ese objectives and furnish highquality and cost-effective clin ical care with greater care coordination (79 FR 40496). As mentioned above, we also proposed to appl y the VM to groups th at consist only of nonphysician eligible professionals , as well as solo practitione rs who are nonphysician eligible professionals beginning in CY 2017 (79 FR 40496). Consistent with the application of the VM to groups of physicians and groups that cont ain both physicians and nonphysician EPs, the quality of care composite for groups that cons ist only of nonphysician EPs and solo practitioner nonphysician EPs would be based on the quality da ta submitted under the PQRS at the group or individual level in accordance with our existing policy. To the extent we are able to attribute beneficiaries to these groups and solo pract itioners under the attri bution methodology proposed in section III.N.4.j of the proposed rule to calcul ate cost measures, we pr oposed to calculate the cost composite using those cost measures. If a cost composite could not be calculated for a group or solo practitioner, then we proposed to classify the group or solo practitioner’s cost

21 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, Batt les JB, Keyes MA, Grady ML, editors. Advances in Patient Safety: New Directions and Altern ative Approaches, Vol 2: Culture and Redesign. AHRQ Publication No. 08-00 34-2. Rockville, MD: Agency for Healthcare Rese arch and Quality; Augu st 2008. p. 321-330.CMS-1612-FC 944

composite as “average” as specified in §414.1270. We solicited comments on all of our proposed policies for applying the VM to nonphysician eligible pr ofessionals beginning in CY

2017. The following is summary of the comments we received on all of our proposed policies for applying the VM to nonphysician elig ible professionals beginning in CY 2017. Comment: Several commenters supported our proposal to apply the VM to nonphysician eligible professionals beginning in CY 2017. Thes e commenters stated that the proposal would support the goal of shared accountabili ty and urged CMS to include th eir cost and quality data in the QRURs. Some of the commenters wanted nonphysician eligible prof essionals to be held harmless from any downward payment adjustments under the VM. Most of the commenters urged CMS to delay implementation of the VM for nonphysician eligible professionals and suggested that CMS adopt a phased approach that gives nonphysician eligible professionals more time to understand and prepare for the implementation of the VM. One commenter was specifi cally concerned abou t nonphysician eligible professionals who are solo practitio ners or in groups with two to nine eligible professionals not having time to prepare for the implementation of the VM. Commenters expressed concern that nonphysician eligible professionals have not been sufficiently prepared for the VM because: prior PFS rules did not indicate th at nonphysician eligible professi onals may be included in the VM in the future; nonphysician eligible profe ssional groups have not yet received a QRUR; nonphysician eligible professionals ha ve not received targeted education regarding application of the VM to them; and the proposal does not a llow nonphysician eligible pr ofessionals the same phased-in approach to the VM that CMS provided to physician groups. One commenter recommended that CMS not apply the VM to nonphysician eligible professionals until CMS adopts meaningful specialty designations. Ot her commenters indicated that some nonphysicianCMS-1612-FC 945

eligible professionals groups will no t be attributed cost measures since they do not bill evaluation and management codes. A few commenters were concerned about the low participation rates of nonphysician eligible professionals in the PQ RS program. A few co mmenters proposed a phased-in approach for implementation of the VM for nonphysician eligible professionals, which they stated would be consistent with the impl ementation of the VM for physician groups. Response: We agree with the commenters th at nonphysician eligible professionals would

benefit from additional time to become familiar with participation in the PQRS program and the VM methodology. Therefore, we are not finali zing our proposal to a pply the VM beginning in the CY 2017 payment adjustment period to nonphysic ian eligible professionals in groups with two or more eligible professionals and to nonphysician eligible professionals who are solo practitioners. Instead, we are fi nalizing that we will apply the VM beginning in the CY 2018 payment adjustment period to nonphysician e ligible professionals in groups with two or more elig ible professionals and to nonphysic ian eligible professionals who are solo practitioners. We added paragraph (a)(4) to §414.1210 to reflect this policy. We note that in the CY 2015 PFS proposed rule, we di d not propose a performance period for the CY 2018 payment adjustment period for the VM. The performance periods we have established in prior rulemaking for the VM have been two calen dar years prior to the beginning of the payment adjustment year (for example, CY 2013 was th e performance period for the VM applied in CY 2015). We expect to propose the performan ce period for the CY 2018 payment adjustment period for the VM in the CY 2016 PFS proposed rule. We believe that delaying the implemen tation of the VM to nonphysician eligible professionals until CY 2018 is consistent with our stated objective to focus on gradual implementation of the VM. The delay would also provide additional time for nonphysician eligible professionals to learn about how to participate in th e PQRS program and to becomeCMS-1612-FC 946

knowledgeable about the policies for calculating the VM. Information about the VM is available on the VM/QRUR website at ht tp://www.cms.gov/Medicare/Medicare-Fee-forService-Payment/PhysicianFeedbackProgram/index.html. Under our final policy, we will apply the VM beginning in CY 2018 to the items and services billed under the PFS by all of the physic ians and nonphysician e ligible professionals who bill under a group’s TIN. We are finalizi ng that we will apply the VM beginning in CY 2018 to groups that consist only of nonphysician elig ible professionals (for example, groups with only nurse practitioners or physicia n assistants). Beginning in CY 2018, the VM will apply to all of the eligible professionals, as specified in section 1848(k)(3)(B) of the Act, that bill under a group’s TIN based on the TIN’s performance duri ng the applicable performance period. During the payment adjustment period, all of the nonphysic ian eligible professionals who bill under a group’s TIN will be subject to the same VM that will apply to the physic ians who bill under that TIN. We are finalizing the proposed modificatio n to the definition of “group of physicians” under §414.1205 to also include the te rm “group” to reflect these final policies. We are also finalizing the policy to a pply the VM beginning in CY 2018 to nonphysician eligible professionals who are solo practitioners. Additionally, we are finalizing that begi nning in CY 2018, physicians and nonphysician eligible professionals will be subject to the sa me VM policies establishe d in earlier rulemakings and under subpart N. For example, nonphysician e ligible professionals wi ll be subject to the same amount of payment at risk and quality-tieri ng policies as physicians. We are finalizing the proposed modifications to the regulati ons under subpart N accordingly. However, since CY 2018 will be the first ye ar that groups that consist only of nonphysician eligible professionals and solo practitioners who are nonphysician eligible professionals will be subject to the VM, we are finalizing a policy to hold these groups and soloCMS-1612-FC 947

practitioners harmless from downward adjustme nts under the quality-tie ring methodology in CY 2018. We will add regulation text under §414.1270 to reflect this policy when we establish the policies for the VM for the CY 2018 payment adjustment period in future rulemaking. c. Approach to Setting the VM Adjustment Based on PQRS Participation

In the CY 2014 PFS final rule with comme nt period (78 FR 74767-74768), we adopted a policy to categorize groups of physicians subj ect to the VM in CY 2016 based on a group’s participation in the PQRS. Specifically, we cate gorize groups of physicians eligible for the CY 2016 VM into two categories. Category 1 includes groups of physicians that (a) meet the criteria for satisfactory reporting of data on PQRS qua lity measures through the GPRO for the CY 2016 PQRS payment adjustment or (b) do not register to participate in the PQRS as a group practice in CY 2014 and that have at least 50 percent of the group’s eligible professionals meet the criteria for satisfactory reporting of data on PQRS qua lity measures as individuals for the CY 2016 PQRS payment adjustment, or in lieu of satisf actory reporting, satisfactorily participate in a PQRS-qualified clinical data re gistry for the CY 2016 PQRS payment adjustment. For a group of physicians that is subject to the CY 2016 VM to be included in Category 1, the criteria for satisfactory reporting (or the criteri a for satisfactory participation, if the PQRS-qualified clinical data registry reporting mechanism is selected ) must be met during the CY 2014 reporting period for the PQRS CY 2016 payment adjustment. For the CY 2016 VM, Category 2 includes those groups of physicians that are subject to the CY 2016 VM and do not fall within Category 1. For those groups of physicians in Category 2, the VM for CY 2016 is -2.0 percent. We proposed to use a similar two-categor y approach for the CY 2017 VM based on participation in the PQRS by groups and solo prac titioners (79 FR 40496). To continue to align the VM with the PQRS and accommodate the various ways in which EPs can participate in the PQRS, for purposes of the CY 2017 VM, we pr oposed that Category 1 would include thoseCMS-1612-FC 948

groups that meet the criteria for satisfactory reporting of data on PQRS quality measures via the GPRO (through use of the web-interface, EHR, or registry reporting mechanisms, as proposed in section III.K of the proposed rule) for the CY 2017 PQRS payment adjustment. Our proposed criteria for satisfactory reporting of data on PQRS quality measures via the GPRO for the PQRS payment adjustment for CY 2017 are described in section III.K of the proposed rule. We also proposed to include in Category 1 groups that do not register to participate in the PQRS as a group practice participating in the PQRS group practice repor ting option (GPRO) in CY 2015 and that have at least 50 percent of the group’ s eligible professionals meet the criteria for satisfactory reporting of data on PQRS quality measures as individuals (through the use of claims, EHR, or registry reporting mechanism, ) for the CY 2017 PQRS payment adjustment, or in lieu of satisfactory reporti ng, satisfactorily participate in a PQRS-qualified clinical data registry for the CY 2017 PQRS payment adjustment , all as proposed in section III.K of the proposed rule. We noted that these proposals are consistent with the policies for inclusion in Category 1 as established for the CY 2016 VM (78 FR 74767 through 74768). We would maintain the 50 percent threshold for the CY 2017 VM as we expand the application of the VM to all groups and solo practitioners in CY 2017. Our proposed criteria for satisfactory reporting by individual eligible professionals for the clai ms, EHR, and registry reporting mechanisms and for satisfactory participation in a qualified clinical data regist ry for the CY 2017 PQRS payment adjustment are described in section III.K of the proposed rule. Lastly, we proposed to include in Category 1 those solo practitioners that meet th e criteria for satisfact ory reporting of data on PQRS quality measures as individuals (through th e use of claims, registry, or EHR reporting mechanism) for the CY 2017 PQRS payment adjust ment, or in lieu of satisfactory reporting, satisfactorily participate in a PQRS-qualified clinical data registry for the CY 2017 PQRS payment adjustment, all as proposed in section III.K of the proposed rule. Category 2 wouldCMS-1612-FC 949

include those groups and solo practitioners that are subject to the CY 2017 VM and do not fall within Category 1. As discussed in the propos ed rule (79 FR 40505), for CY 2017, we proposed to apply a -4.0 percent VM to groups with two or more elig ible professionals and solo practitioners that fall in Category 2. We solicited co mment on these proposals. The following is summary of the comme nts we received on these proposals. Comment: A number of commenters supported our proposal to continue to account for eligible professionals th at participate in the PQRS as indivi duals in the determination of groups and solo practitioners that would be in Categor y 1. One commenter indi cated that our proposals allow groups to have the flexibility to choose a PQRS reporting mechanism that best fits the practice. One commenter did not support th e use of both group and individual reporting mechanisms to determine whether a group fa lls in Category 1, indicating that it makes comparisons among groups that choose to report as a group compared to a group whose eligible professionals report as i ndividuals inequitable. Response: We appreciate commenters’ support for our proposal to provide a way to combine individually reported PQRS measures into a group score for purposes of the CY 2017 VM. In response to the commenter’s concern about the use of the individual reporting mechanisms in the VM, we believe that the use of both the individually reported PQRS measures and the PQRS GPRO measures to calculate the quality composite of the VM recognizes recognize the diversity of physician practices and the various measures used to assess quality of care furnished by these practices. As we stat ed in the CY 2014 PFS final rule with comment period (78 FR 74767), one of the principles governi ng our implementation of the VM is to align program requirements to the extent possible. Thus , we expect to continue to align the VM with the PQRS program requirements and reporting mech anisms to ensure physicians and groups of physicians report data on quality measur es that reflect th eir practice.CMS-1612-FC 950

Furthermore, we do not believe that compar ing quality composite scores based on PQRS GPRO measures or individually reported PQRS measures would create inequities because a group’s performance reflects the underlying eligible professiona ls on whose behalf the group reports and the quality measure benchmarks are inclusive of data gathered through both PQRS GPRO and individually-reported PQRS measures . Lastly, we note that the inclusion of individual PQRS measure in the VM provides an additional mechanism and reduces additional reporting burden for groups that are subject to the VM and do not report under the PQRS as a group to avoid an automatic VM downward payment adjustment.

After consideration of the comm ents received, and for the reasons stated previously, we are finalizing the two-category approach for the CY 2017 VM based on participation in the PQRS by groups and solo practitioners as proposed. For purposes of the CY 2017 VM, Category 1 will include those groups that meet th e criteria for satisfact ory reporting of data on PQRS quality measures via the GPRO (through us e of the web-interface, EHR, or registry reporting mechanism, as finalized in section III.K of this final rule with comment period) for the CY 2017 PQRS payment adjustment. Our final criteria for satisfactory reporting of data on PQRS quality measures via the GPRO for the PQRS payment adjustment for CY 2017 are

described in Table 51 in section III.K of this final rule with comment period. We also are finalizing to include in Category 1 groups that do not register to participate in the PQRS as a group practice participating in th e PQRS GPRO in CY 2015 and that have at least 50 percent of the group’s eligible professionals meet the criteria for satisfact ory reporting of data on PQRS quality measures as individua ls (through the use of claims , EHR, or registry reporting mechanism) for the CY 2017 PQRS payment adjust ment, or in lieu of satisfactory reporting, satisfactorily participate in a PQRS-qualified clinical data registry for the CY 2017 PQRS payment adjustment, all as finalized in Table 50 in section III.K of this final rule with commentCMS-1612-FC 951

period. Our final criteria for satisfactory reportin g by individual eligible professionals for the claims, EHR, and registry reporting mechanisms and for satisfactory part icipation in a qualified clinical data registry for the CY 2017 PQRS paym ent adjustment are described in section III.K of this final rule with comment period. Lastly, we ar e finalizing to include in Category 1 those solo practitioners that meet the criteria for satisfact ory reporting of data on PQRS quality measures as individuals (through the use of claims, registry, or EHR reporting mechanism) for the CY 2017 PQRS payment adjustment, or in lieu of satisf actory reporting, satisfactorily participate in a PQRS-qualified clinical data regi stry for the CY 2017 PQRS paymen t adjustment, all as finalized

in Table 50 in section III.K of this final rule with comment period. Category 2 will include those groups and solo practitioners that are subject to the CY 2017 VM and do not fall within Category 1. We will continue to explore how to incl ude additional data for specialists, including potentially incorporating Hospital VBP Program performance into the VM, as discussed in

section III.N.4.k of this final rule with comme nt period. We would adopt any such changes through future notice and comment rulemaking. As discussed in section III. N.4.f of this final rule with comment period, for CY 2017, we are fi nalizing policies to (1) apply a -4.0 percent VM to groups with 10 or more eligible professiona ls that fall in Categor y 2, and (2) apply a -2.0 percent VM to groups with two to nine eligible professionals and solo pr actitioners that fall in Category 2. For a group and a solo practitioner subject to the CY 2017 VM to be included in Category 1, the criteria for satisfact ory reporting (or the criteria for satisfactory participation, in the case of solo practi tioners and the 50 percent option desc ribed above for groups) must be met during the reporting periods occu rring in CY 2015 for the CY 2017 PQRS payment adjustment. As noted in section III.5.g of this final rule with comment period earlier, CY 2015 is the performance period for the CY 2017 payment adjustment period for the VM.CMS-1612-FC 952

In the CY 2014 PFS final rule with comme nt period (78 FR 74768-74770), we finalized that the quality-tiering methodol ogy will apply to all groups in Category 1 for the VM for CY 2016, except that groups of physicians with betwee n 10 and 99 eligible professionals would be subject only to upward or ne utral adjustments derived unde r the quality-tiering methodology, while groups of physicians with 100 or more eligible professiona ls would be subject to upward, neutral, or downward adjustments derived under the quality-tiering methodology. In other words, we finalized that groups of physicians in Category 1 with betw een 10 and 99 eligible professionals would be held harmless from any downward adjustments derived from the qualitytiering methodology for the CY 2016 VM. For the CY 2017 VM, we proposed to continue a similar phase-in of the quality-tiering based on the number of eligible professionals in the group (79 FR 40497). We proposed to apply the quality-tiering methodology to all groups and solo practitioners in Category 1 for the VM for CY 2017, except that groups with two to nine elig ible professionals and so lo practitioners would be subject only to upward or neutral adjust ments derived under the quality-tiering methodology, while groups with 10 or more elig ible professionals would be s ubject to upward, neutral, or downward adjustments derived under the quality-tiering methodology. That is, we proposed that solo practitioners and groups with two to nine e ligible professionals in Category 1 would be held harmless from any downward adjustments derive d from the quality-tiering methodology for the CY 2017 VM. Accordingly, we proposed to re vise §414.1270 to reflect these proposals. We believe this approach would rewa rd groups and solo practitioners that provide high-quality/lowcost care, reduce program complexity, and would al so fully engage groups and solo practitioners into the VM as we complete the phase-in of the VM in CY 2017. We solicited comments on these proposals.CMS-1612-FC 953

We stated in the CY 2015 PFS proposed rule (79 FR 40497) that we believe it is appropriate to hold groups with two to nine elig ible professionals and solo practitioners in Category 1 harmless from any downward adju stments under the quality-tiering methodology, which is similar to the policy we apply to groups with between 10 and 99 eligible professionals during the first year the VM app lies to them (CY 2016). We noted that we anticipate applying the CY 2018 VM with both upward and downward adjustments based on a performance period of CY 2016 to all groups and solo practitioners, and th erefore, we would make proposals in future rulemaking accordingly. We stated that, for groups with between 10 and 99 eligible professionals , we believe it is appropriate to begin both the upward and the downward payment adjustments under the qualitytiering methodology for the CY 2017 VM. As stat ed in the CY 2014 PFS final rule with comment period (78 FR 74769), on September 16, 2013, we made available to all groups of 25 or more eligible professionals an annual QRUR based on 2012 data to help groups estimate their quality and cost composites. As discussed in se ction III.N.4.a. of this final rule with comment period, in September 2014, we made available QR URs based on CY 2013 data to all groups of physicians and physicians who are solo practi tioners. These QRURs contain performance information on the quality and cost measures used to calculate the quality and cost composites of

the VM and show how all TINs fare under the policies established for the VM for the CY 2015 payment adjustment period. As noted above, we are considering providing semi-annual QRURs with updated cost and resource use information to groups and solo practi tioners. Then, during the summer of 2015, we intend to disseminate QR URs based on CY 2014 data to all groups and solo practitioners, and the reports would show how all TINs would fare under the policies established for the VM for the CY 2016 payment adjustment period. The QRURs will alsoCMS-1612-FC 954

include additional information about the TINs’ performance on the MSPB measure, individuallyreported PQRS measures, and the speci alty-adjusted cost measures. Thus, we stated that we believe groups with between 10 and 99 eligible professionals will have adequate data to improve performance on the qua lity and cost measures that will be used to calculate the VM in CY 2017. As a result, we be lieve it is appropriate to apply both upward and downward adjustments under the quality-tiering me thodology to groups with 10 or more eligible professionals in 2017. Based on an analysis of CY 2012 claims, we es timate that approximate ly 6 percent of all eligible professionals are in a Category 1 TIN that would be classified in ti ers that would earn an upward adjustment by having a composite score that is at least 1 standard deviation away from the mean composite and it is statistically signifi cant, approximately 11 pe rcent of all eligible professionals are in a Category 1 TIN that would be classified in tiers that would receive a downward adjustment by having a composite score th at is at least 1 stan dard deviation away from the mean composite and it is statistically significant, and approxima tely 83 percent of all eligible professionals are in a Category 1 TIN that would receive no payment adjustment in CY 2017. These results suggest that our quality-t iering methodology identifies a small number of groups and solo practitioners that are outliers – both high and low performers – in terms of whose payments would be affected by the VM, thus limiting any widespread unintended

consequences. We stated in the CY 2015 PFS proposed rule th at we will continue to monitor the VM program and continue to examine the characteristic s of those groups that could be subject to an upward or downward payment adjustment under our quality-tiering methodology to determine whether our policies create anomalous effects in ways that do not re flect consistent differences in performance among physicians and physician groups.CMS-1612-FC 955

The following is a summary of the comments we received on these proposals. Comment: Several commenters supported appl ying quality-tiering to all groups and solo practitioners. One commenter did not support the concept of quality -tiering and indicated that it should be voluntary for all pract ices. Most commenters strongly supported our proposal to hold harmless groups with two to nine eligible profe ssionals and solo practitioners from downward payment adjustments in CY 2017, although one co mmenter suggested th at CMS should apply downward adjustments to them. Some comment ers supported our propo sal to apply upward, neutral, or downward payment adjustment to physician groups with 10 or more eligible professionals. However, many commenters had concerns about applying the downward adjustment to groups with 10 or more eligible professionals, since we proposed a maximum downward adjustment of -4.0 percent. A comm enter indicated that there is a substantial operational difference between large practices and small practices since larger practices have

more resources and revenue and are better suit ed to absorb downward payment adjustments

under the VM. Some commenters were concer ned that implementation of the downward adjustment to smaller physician practices, partic ularly given that the downward adjustment is slated to be -4.0 percent in 2017, may negativel y impact beneficiary access to care. Other comments stated that solo practit ioners and groups with two to tw enty-four eligible professionals would not have a QRUR until the fall 2014 and will ha ve little time to an alyze their performance

data. A number of commenters recommended more intermediate , phased-in approach to the downward adjustment such as holding harmless gr oups with less than 25 eligible professionals, 50 eligible professionals, or all groups regardless of size. Comme nters suggested that we give only upward or neutral payment adjustments to all groups and solo practitioners or keep the CY 2016 policies in place for the CY 2017 VM. One commenter suggested that physician groups be able to file for a hardship exception with CMS in the event they face a downward adjustmentCMS-1612-FC 956

under the VM. One commenter suggested that the payment adjustments under quality-tiering apply to all groups regardless of size so that primary care phy sicians who practice in larger groups are not disadvantaged, while another sugg ested that CMS should not change the program in 2017. Some commenters request ed demographic information a bout the outliers that would receive upward or downward adjust ments based on quality-tiering. Response: We appreciate the commenters’ s upport of our proposal to apply the qualitytiering methodology to all groups an d solo practitioners in Cate gory 1 for the VM for CY 2017 and to hold solo practitioners and groups with tw o to nine eligible professionals in Category 1 harmless from any downward adjustments derive d from the quality-tiering methodology for the CY 2017 VM. We disagree with commenters who suggested that we should not apply upward, neutral, or downward payment adjustments derived under the quality-tiering methodology to physician groups with 10 or more eligible profes sionals in CY 2017. For groups with 10 or more eligible professionals, we believe it is appropr iate to apply both the upward and the downward payment adjustments under the quality-tiering methodology for the CY 2017 VM. As stated in the CY 2014 PFS final rule with comment period (78 FR 74769), on September 16, 2013, we made available to all groups of 25 or more e ligible professionals an annual QRUR based on 2012 data to help groups estimate their quality and cost composites. As discussed in section III.N.a. of this final rule with comment period, in Sept ember 2014, we made available QRURs based on CY 2013 data to all groups of physicians and physicians who are solo practitione rs. We believe that groups of 10 or more eligible professionals will have adequate data to improve performance on the quality and cost measures that will be used to calculate the VM in CY 2017. As a result, we believe it is appropriate to apply both upward and downward adjustments under the qualitytiering methodology to groups with 10 or mo re eligible professionals in 2017.CMS-1612-FC 957

With regard to the commenters’ concerns over the impact of the proposed maximum -4.0 percent downward adjustments on small practices, as discussed in section III.N.4.f of this final rule with comment period, we are finalizing a pol icy to apply a -2.0 percent VM to groups with two to nine eligible professionals and solo practitioners that fa ll in Category 2. We believe the revised policy will alleviate some of the comm enters’ concerns about the financial impact of applying quality-tiering to small groups and solo practitioners in CY 2017. With regard to the suggestion that physicians in groups of 10 to 24 eligible professionals have not had sufficient experience with the quali ty measures used in the VM, we note that on September 30, 2014, we made QRURs available to all group of physicians and physicians who are solo practitioners based on their performan ce in CY 2013. Each QRUR contains the group or solo practitioner’s performance in formation on the quality and cost measures used to calculate the quality and cost composites of the VM and show how the TIN would fare under the policies established for the VM for the CY 2015 payment ad justment period. As we stated in the CY 2015 PFS proposed rule, we believe it is appropriate to hold groups with two to nine eligible professionals and solo practitioners in Cate gory 1 harmless from any downward adjustments under the quality-tiering methodology, which is similar to the policy we apply to groups with between 10 and 99 eligible professi onals during the first year the VM applies to them (CY 2016). For groups with between 10 and 99 e ligible professionals, we believe it is appropriate to begin both the upward and the downward payment ad justments under the quality-tiering methodology for the CY 2017 VM. We believe that these gr oups have had sufficient time to understand how the VM works and how to participate in the PQRS. We note that th e 2013 QRUR Experience Report, as described in section III.N.4.a of this final rule, will also cont ain additional information about the groups that were determined to have cost and/or quality performance that was significantly different than averag e, as determined under the polic ies established for the VM forCMS-1612-FC 958

the CY 2015 payment adjustment period. We reite rate our belief that the final policies will reward groups and solo practitioners that pr ovide high-quality/low-cost care, reduce program complexity, and will also fully engage groups and solo practitioners into the VM as we complete the phase-in of the VM in CY 2017. After considering the public comments receiv ed, we are finalizing the application of the quality-tiering methodology to all gr oups and solo practitioners in Category 1 for the VM for CY 2017, except that groups with two to nine eligible professionals a nd solo practitioners would be subject only to upward or ne utral adjustments derived unde r the quality-tiering methodology, while groups with 10 or more elig ible professionals would be s ubject to upward, neutral, or downward adjustments derived under the quality -tiering methodology. In other words, solo practitioners and groups with two to nine eligible pr ofessionals in Category 1 would be held harmless from any downward adjustments derive d from the quality-tiering methodology for the

CY 2017 VM. d. Application of the VM to Physicians and N onphysician Eligible Professi onals that Participate in the Shared Savings Program, the Pioneer AC O Model, the CPC Initiative, or Other Similar

Innovation Center Models or CMS Initiatives We established a policy in the CY 2013 PFS final rule with comment period (77 FR 69313) to not apply the VM in CY 2015 and CY 2016 to groups of physicians that participate in the Shared Savings Program Acco untable Care Organizatio ns (ACOs), the Pioneer ACO Model, the Comprehensive Primary Care (CPC) Initiative, or other similar Innovation

Center or CMS initiatives. We stated in the CY 2014 PFS final rule with comment period (78 FR 74766) that from an operational perspectiv e, we will apply this policy to any group of physicians that otherwise would be subject to the VM, if one or more physician(s) in the groupCMS-1612-FC 959

participate(s) in one of these programs or initia tives during the relevant performance period (CY 2013 for the CY 2015 VM, and CY 2014 for the CY 2016 VM). Although section 1848(p)(4)( B)(iii)(I) of the Act gives th e Secretary discretion to apply the VM beginning on January 1, 2015 to specif ic physicians and groups of physicians the Secretary determines appropriate, section 1848(p)(4)(B)(iii )(II) of the Act requires application of the VM beginning not later than January 1, 2017 to all physicians and groups of physicians. Therefore, as discussed in section III.N.4.a. of this final rule with comment period, we proposed to apply the VM to all physicians in groups with two or more eligible professionals and to solo practitioners who are physicians st arting in CY 2017. In section II I.N.4.b of this final rule with comment period, we discussed our proposal to also apply the VM starting in CY 2017 to all nonphysician eligible professionals in groups with tw o or more eligible prof essionals and to solo practitioners who are nonphysician e ligible professionals. We desc ribe in this section how we proposed to apply the VM beginning in th e CY 2017 payment adjustment period to the physicians and nonphysician eligible professionals in groups, as well as those who are solo practitioners, participating in the Shared Savings Program, Pioneer ACO Model, the CPC Initiative, or other similar Innovation Center models or CMS initiatives. (1) Physicians and Nonphysician Eligible Profes sionals that Participat e in ACOs under the Shared Savings Program (a) Application of the VM to participants in the Shared Savings Program. Beginning with the CY 2017 payment adjustment period, we proposed to apply the VM to physicians and nonphysician eligible professionals in groups with two or more el igible professionals and to physicians and nonphysician eligible professionals who are solo prac titioners participating in the Shared Savings Program (79 FR 40497). Groups and solo practitioners part icipate in the Shared Savings Program as part of an ACO as provided in section 1899 of the Act. Under the SharedCMS-1612-FC 960

Savings Program, an ACO may consist of multiple participating groups and solo practitioners (as identified by the ACO participants’ TINs). As of April 1, 2014, there are 338 ACOs participating in the Shared Savings Program. Th is number includes 31 ACOs that consist of only one ACO participant TIN. The ACO submits quality data on behalf of all the ACO participant

TINs in that ACO under the Shared Savings Program. Comment: Many commenters suggested that we should continue to exempt Shared Savings Program participants from the VM. These commenters stated that because participants in the Shared Savings Program have already taken on accountability for quality improvement and cost reduction, it is unnecessary and confusing to apply the VM to these providers. Several commenters suggested that this op tion is available under the existi ng language of the statute or that, if CMS believes it does not have this authority, we should seek it from Congress. Commenters also expressed concer n that applying the VM to part icipants in the Shared Savings Program would cause inappropria te comparisons of performa nce and create confusion by sending mixed signals about cost and quality benchmarks. Severa l of these commenters stated that organizations participating in Shared Savings Program and Pi oneer ACOs are making significant investments and that th ey believe this further undersc ores the importance of allowing these groups to focus on one set of pay for pe rformance metrics to avoid creating additional

investment costs. A few comme nters supported the application of the VM to Shared Savings Program participants because they believe thatapplying the VM broadly will encourage valuebased change. Response: We disagree with commenters w ho believe we should continue to exempt groups and solo practitioners who participate in the Shared Savings Program from the VM. We are required under section 1848(p)(4)( B)(iii)(II) of the Act to apply the VM to all physicians and groups of physicians no later than January 1, 2017 , and we believe that alignment of theseCMS-1612-FC 961

programs emphasizes the importance of quality reporting and quality measurement, for improvement of the quality of care provided to Medicare beneficiaries. We understand the concerns presented by the commenters regarding calculation of the cost and quality composites under the VM, and we address them below, in se ctions III.N.4.d.1(b) and (c) of this final rule with comment period. After considering the public comments on this proposal, we are fina lizing our policy to apply the VM, beginning with the CY 2017 payment adjustment period, to physicians in groups with two or more eligible professionals and physic ians who are solo pract itioners that participate in an ACO under the Shared Savings Program. We note that, in response to commenters’ con cerns, we are not finalizing the proposal to apply the VM to nonphysician eligible professiona ls in the CY 2017 payment adjustment period that participate in an ACO under the Shared Savings Program, cons istent with the final policy for groups and solo practitioners that do not pa rticipate in the Shared Savings Program as

discussed in section III.N.4.b of this final rule with comment pe riod. Also, consistent with our policy discussed in section III.N.4.b to appl y the VM beginning with the CY 2018 payment adjustment period to nonphysicia n eligible professionals who are not in an ACO under the Shared Savings Program, we will apply th e VM beginning with the CY 2018 payment adjustment period to nonphysician eligible professionals in groups with two or more eligible professionals and nonphysician eligible professionals who are solo practitioners that participate in an ACO under the Shared Savings Program. We further note that, based in part on concerns identified by commenters, we are finalizing polic ies in sections III.N.4.d.1 (b) and (c) of this final rule with comment period that take into consideration a group or solo practitioner’s participation in an ACO under the Shared Sa vings Program during the performance period for the VM, rather than participation during the pa yment adjustment period for the VM as proposed.CMS-1612-FC 962

(b) Calculation of the cost composite of the VM for Shared Savings Program participants. Beginning with the CY 2017 payment adjustment period, we proposed to classify the cost composite for the VM as “average cost” for grou ps and solo practitione rs (as identified by the ACO’s participant TINs) that participate in the Shared Savings Progr am during the payment adjustment period (for example, CY 2017) (79 FR 40498). We proposed to apply “average cost” to these groups and solo practit ioners regardless of whether they participated in the Shared Savings Program during the performance peri od (for example, in CY 2015 for the CY 2017 VM). We believe that it would not be appropr iate to apply the quali ty-tiering methodology to calculate the cost composite for these groups and solo practitioners because of the differences in the methodology used to calculate the cost benc hmarks under the Shared Savings Program and the VM. Under the Shared Savings Program, cost benchmarks are based on the actual historical Medicare fee-for-service expenditu res for beneficiaries that woul d have been assigned to the ACO during the historical benchmark period, and are updated to reflect changes in national FFS spending; however, the cost benchmarks under the VM are based on national averages. We believe that these are signif icant differences in the met hodology for calculating the cost benchmarks under the two programs. Consequently, we believe that any attempt to calculate the VM cost composite for groups and solo practi tioners participating in the Shared Savings Program using the VM quality-tiering methodology would create two sets of standards for ACOs for their cost performance. We believe that ha ving two sets of standards for participants in ACOs for cost performance would be inappropr iate and confusing and could send conflicting messages and create conflicting incentives. We solicited comments on our proposals to classify the cost composite as “average cost” for groups and solo practitioners who participate in the Shared Savings Program during the payment adjustment period.CMS-1612-FC 963

For groups and solo practitioners who partic ipate in the Shared Savings Program during the performance period (for example, CY 2015), but no longer participate in the Shared Savings Program during the payment adjustment period (f or example, CY 2017), we proposed to apply the quality-tiering methodology to calculate the cost composite for the VM for the payment adjustment period based on the groups’ and so lo practitioners’ perf ormance on the cost measures, as identified under §414.1235, during the performance period (79 FR 40499). We stated that it would be appropr iate to calculate their cost composite under the quality-tiering methodology because these groups and solo practit ioners are no longer part of the Shared Savings Program during the payment adjustment period. Comment: As noted above, many commenters expressed concern th at applying the VM to ACO participants in the Shared Savings Pr ogram would cause inappropriate comparisons of performance and create confusion by sending mixed signals about cost benchmarks. Several of these commenters who were opposed to the appli cation of the VM to Shared Savings Program ACO participants suggested that we should c ontinue to exempt Shared Savings Program participants from the VM, but stated that if we were to apply the VM to Shared Savings Program ACO participants, we should classify the cost composite as “average cost” because of the differing methodologies for assessing cost perf ormance for the VM and the Shared Savings Programs. A few commenters stated that groups or solo practitioners participating in the Shared Savings Program should have their cost composite calculated without regard to participation in the Shared Savings Program and disagreed w ith our proposed policy because it limits the potential upward adjustment under the VM av ailable to groups and solo practitioners participating in the Shared Savings Program. Response: We understand the concerns presen ted by these commenters that calculating a cost composite for these groups and solo prac titioners could cause c onfusion and send mixedCMS-1612-FC 964

signals. The VM and Shared Savings Programs ar e sufficiently different such that it would be counterproductive at this point in the programs’ development to measure groups and solo practitioners using different cost measures under each program. To allow Shared Savings Program participants to focus their energy and resources on the Shared Savings Program targets for slowing expenditure growth, a different approach under the VM program for groups and physicians participating in the Shared Savings Program is appropriate. We will finalize our proposal to classify the cost co mposite for groups and solo practi tioners participating in an ACO under the Shared Savings Program as “average co st” to avoid confusion and prevent conflicting incentives for these providers who have already committed to reducing cost growth through their participation in the Shared Savings Program. We plan to investigat e the possibility of calculating a VM cost composite at the ACO le vel in the future, so that groups and solo practitioners in ACOs would have the opportuni ty to earn the full upward adjustment in the future, and we would address this issue in future rulemaking. Comment: We received several comments object ing to our proposal to take into account a group or solo practitioner’s participation in a Shared Savings Program ACO during the payment adjustment period for the VM. A few commenters did not support our proposal to apply “average cost” to groups and solo practitione rs that join a Shared Savings Program ACO in the payment adjustment period, but were not in a Shared Savings Program ACO in the performance period. These commenters pointed out that this policy coul d discourage groups and solo practitioners from joining an ACO if it would mean they would not receive an earned upward adjustment in the payment adjustment pe riod. One of these commenters suggested that groups or solo practitioners should be given the option to have their cost composite calculated under the quality-tiering methodology if they were not in an ACO in the performance period. Several commenters suggested that all groups and solo practitioners should be given theCMS-1612-FC 965

opportunity to “opt in” to having their cost composite calculated re gardless of whether they were in an ACO in the performance period. Another commenter objected to our proposal to apply the quality-tiering methodology to calculate the cost composite for groups and solo practitioners that participate in the Shared Savings Program in the performance period but do not participate in the Shared Savings Program during the payment adjust ment period. The commenter suggested that these groups should be classified as “average cost” because they would have been working toward ACO cost benchmarks during the performance year. Response: We are convinced by commenters w ho raised concerns with our proposal to consider a group or solo practit ioner’s participation in a Shar ed Savings Program ACO during the payment adjustment period for the purpose of de termining the applicability of the VM to the group or solo practitioner. We believe that comm enters have accurately pointed out that Shared Savings Program ACO participants would be worki ng toward a specified se t of quality and cost metrics during the performance period, and that the performance period would therefore, best

define their status as a Shared Savings Program participant for the purpose of determining the applicability of the VM during th e associated payment adjustment period. We agree with the points raised in the comments about assessing a group or solo practiti oner under the VM cost measures and benchmarks in the payment adjustment period if that group or solo practitioner was participating in an ACO under the Shared Savi ngs Program in the performance period. A group or solo practitioner is unlikely to know two years in advance that it plans to leave an ACO, and we do not believe it would appropriate to assess the group or solo practitioner under a different set of cost measures than those that the group or solo practitioner had been working toward in the performance period as part of an ACO. As stated in our proposed rule (79 FR 40498), we believe that having two sets of standards for ACOs fo r cost performance would be inappropriate and confusing. We believe that the Shared Savings Program has the potential to reduce expenditureCMS-1612-FC 966

growth and improve quality and we do not want to discourage groups or solo practitioners from participating in that program (79 FR 40498). Consistent with that stated inte nt, and in light of the comments we received pointing out the potential conflict if we were to calculate a cost composite for groups and solo practitioners that participated in an ACO under the Shared Savings Program but did not participate in the payment adjustment period, we believe it is appropriate to apply “average cost ” to all groups and solo practiti oners that participate in an ACO under the Shared Savings Program in the performance period regardless of whether the group or solo practitioner remains in the ACO in the payment adjustment period. We do not, however, believe that it would be appropriate to use an “opt in” policy for groups or solo practitioners participatin g in Shared Savings Program ACOs. We believe that allowing groups and solo practitioners who participate in the Sh ared Savings Program in the performance period to “opt in” to having their cost composite calcu lated would conflict with our intent to avoid setting multiple financial benchmarks for these groups and solo practitioners. After considering the public comments receiv ed, we are finalizing our policy to classify the cost composite as “average co st” for groups and solo practitione rs that participate in an ACO under the Shared Savings Program. Unlike our pr oposed policy, which considered participation in a Shared Savings Program ACO during the pa yment adjustment period for the VM (for example, CY 2017), we are finalizing a policy that, if a group or solo prac titioner participates in a Shared Savings Program ACO during the applicab le performance period (for example, the CY 2015 performance period for the CY 2017 payment adju stment period), then that group or solo practitioner’s cost composite will be classified as “average cost,” regard less of whether the group or solo practitioner participates in a Shar ed Savings Program ACO during the payment adjustment period. In addition to addressing so me of the concerns raised by commenters, we believe this final policy is consistent with our existing policy for CYs 2015 and 2016, underCMS-1612-FC 967

which a group’s participation in the Shared Savings Program during the performance period (CYs 2013 and 2014, respectively) is relevant for pur poses of determining whether to exempt the group from application of the VM during the re levant payment adjustment period. Further, utilizing the performance period for the purpos e of determining whether the group or solo practitioner is a Shared Savings Program ACO participant eliminates the need for us to calculate preliminary payment adjustment factors prior to the beginning of the payment adjustment period, and then recalculate the payment adjustment fact ors after the final ACO participation list is completed, as we had proposed to do (79 FR 40506). As requested by commenters, this fina l policy is also simpler than our proposal, because it does not take into account a group’s status during the payment adjustment period. (c) Calculation of the quality composite under the VM for Shared Savings Program participants. Beginning with the CY 2017 paymen t adjustment period, we proposed to calculate the quality of care composite score for the VM fo r groups and solo practi tioners who participate in an ACO under the Shared Savings Program in accordance with the foll owing policies (79 FR 40498-40499):

● We proposed to calculate the quality ofcare composite score based on the qualitytiering methodology using quality data submitted by the ACO, as discussed in section III.N.4.h

of this final rule with comment period, from the performance pe riod and apply the same score to all of the groups and solo pract itioners under the ACO during the payment adjustment period. In other words, using CY 2017 as an example, we proposed to calculate the quality of care composite score for the CY 2017 VM for all of the groups and solo practiti oners participating in

the ACO in CY 2017 based on the ACO’s CY 2015 quality data. We note that in section III.N.4.h of this final rule with comment period, we are finalizing our proposal to exclude the

claims-based outcome measures identified under §414.1230 from the calculation of the quality ofCMS-1612-FC 968

care composite score for groups and solo practitio ners who participate in the Shared Savings Program as described in section III.N.4.d.1 of th is final rule with comment period.

● For groups and solo pract itioners who participate in the ACO during the payment adjustment period (for example, CY 2017) and eith er did not participate in the Shared Savings Program or were part of a different ACO duri ng the performance period (for example, CY 2015), we proposed to calculate the quality of care composite scor e based on the quality-tiering methodology using the quality data submitted by the ACO from the performance period. For example, if a group or solo pr actitioner is in ACO 1 during CY 2017, and either was not in the Shared Savings Program or wa s part of ACO 2 during CY 2015, we would use ACO 1’s quality data from CY 2015 to calculate the quality of care composite. This approach is consistent with our policy not to “track” or “carry” an individu al professional’s perfor mance from one TIN to another TIN (see 77 FR 69308 through 69310). In ot her words, if a professional changes groups from TIN A in the performance period to TIN B in the payment adjustment period, we would apply TIN B’s VM to the professional’s paymen ts for items and services billed under TIN B during the payment adjustment period.

● If the ACO did not exist during the performance period (for example, CY 2015), then we would not have the ACO’s quality data to use in the calculation of the quality of care composite score for the payment adjustment period (for example, CY 2017). Therefore, if the ACO exists during the payment adjustment peri od but did not exist during the performance period, we proposed to classify the quality of car e composite for all groups and solo practitioners who participate in the ACO during the payment ad justment period as “average quality” for the payment adjustment period. We proposed to apply this policy to groups and solo practitioners regardless of their status during the performance period – in othe r words, regardless of whether they participated in the Shared Savings Program as part of a different ACO, or did not existCMS-1612-FC 969

during the performance period (for example, a TI N forms or newly enrolls in Medicare after the end of the performance period). We believed th is proposal was appropria te since we would not have the ACO’s quality data from the perfor mance period to calculate a quality of care composite for all of the groups and solo prac titioners participating in the ACO during the payment adjustment period. We noted that some of these groups and solo practitioners may have participated in the PQRS during the performance period; therefore, we would have quality data for those groups and solo practitioners. If they were part of a different ACO during the performance period, then we would also have that ACO’s quality data. We stated that we did not, however, believe that it would be appropria te to use the groups’ a nd solo practitioners’ PQRS or other ACO quality data from the performance period to calculate a quality of care composite because the groups and solo practitione rs are part of a new ACO during the payment adjustment period. We stated our belief that this approach would be consistent with our policy not to “track” or “carry” an indi vidual professional’s performan ce from one TIN to another TIN (see 77 FR 69308 through 69310). In this case, if a TIN’s status changes from the performance period to the payment adjustment period (that is, participating in ACO 2 or not participating in the Shared Savings Program in the performance pe riod, to participating in ACO 1 in the payment adjustment period), then we proposed that we w ould not “track” or “carry” ACO 2’s quality data or the TIN’s PQRS quality data to determine th e quality of care composite for groups and solo practitioners who participate in ACO 1.

● For groups and solo practi tioners who participate in the Shared Savings Program during the performance period (for example, CY 2015) but no longer participate in the Shared Savings Program during the payment adjustment period (for example, CY 2017), we proposed to classify the quality of care composite as “average quality” for the VM for the payment adjustment period. Since these groups and solo practitioners were part of an ACO during theCMS-1612-FC 970

performance period, we would have the ACO’s quality data from that period. We stated that we did not believe it would be appropriate to us e the ACO’s quality data from the performance period to calculate a quality of care composite because the groups and so lo practitioners are no longer part of the ACO during the payment adjustment period. We stated this approach is also consistent with our policy not to “track” or “carry” an individual professional’s performance from one TIN to another TIN (see 77 FR 69308 through 69310). Even though we proposed to classify the quality of care composite for thes e groups and solo practitioners as “average quality,” we solicited comments on whether we should use the ACO’s quality data from the performance period to calculate the quality compos ite for these groups and solo practitioners for the payment adjustment period. We solicited comments on all of our proposal s to calculate the quality composite for groups and solo practitioners pa rticipating in the Shared Sa vings Program. We provided a summary of the proposals in the proposed rule in Table 56 using TIN A and ACO 1 and ACO 2 as examples (79 FR 40499). Comment: As noted above, in the discussion of the cost composite, we received many comments stating that we should exempt groups and solo practitioners from the 2017 VM. Many commenters also suggested an “Innovation Pathway” approach for participants in the Shared Savings Program and Innovation Cent er initiatives. Under this suggested approach, groups and solo practitioners participating in the Shared Savings Program or ot her Innovation Center initiatives would receive “average cost” and “average quality” unless they opted to have their VM calculated. The reasoning behind this appro ach, provided by commenters, is to allow ACOs and the participating groups a nd solo practitioners to focus on one set of cost and quality benchmarks and avoid confusion predicted by some commenters. Many commenters also believe that applying the VM to these groups and solo practiti oners could lead to “doubleCMS-1612-FC 971

counting” positive or negative performance. A few commenters stated that if we are to apply the VM to groups and solo practiti oners in the Shared Savings Program, they should only be subject to a neutral or an upward adjustment. Some commenters supported our pr oposed policies related to cost and quality composites, and one commente r stated that if the VM is applied to these groups, they believed that only a quality compos ite should be calculated because they believe that ACOs are already rewarded for reducing co sts. We also received comments on the specific quality measures and benchmarks that we proposed to use for the VM for groups and solo practitioners participating in the Shared Savi ngs Program, which we address in section III.N.4.h

of this final rule with comment period. Response: We appreciate commenters’ co ncern about the potential for conflicting incentives on cost and quality performance when applying the VM to Sh ared Savings Program participants given that these participants are alre ady working toward a set of cost efficiency and quality improvement goals through the Shared Savings Program. We continue to believe, however, that it is appropriate to calculate a qua lity composite for groups and solo practitioners participating in the Shared Savings Program base d on the ACO’s quality data. We appreciate the support of commenters who agreed that it is ap propriate to calculate a quality composite for these groups and solo practitioners based on the ACO’s quality data. We disagree with commenters who believe it would be inappropria te to calculate a VM for groups and solo practitioners that participate in the Shared Savings Program b ecause this could be seen as “double counting” performance. We believe that application of the VM to providers who participate in the Shared Savings Program reinfo rces the importance of quality improvement and quality reporting by offering participants in the Shared Savings Program an opportunity to earn an upward adjustment for improved performance. We agree with the commenter who stated if calculating a VM for Shared Savi ngs Program participants, we s hould only calculate the qualityCMS-1612-FC 972

composite. However, we would like to point ou t that the Shared Savings Program does also reward high quality care in addition to reward ing reductions in cost growth. Unlike the differences between the methodologies for evalua ting costs under the Shared Savings Program and the VM, we do not believe that the differenc es between the quality methodologies for these two programs will create significant confusion or conflicting incentives. Because the GPRO web

interface measures are consistent across the VM and Shared Savings Program, we believe that it

will not create undue burden on ACO participants or cause significant confusion to calculate a quality composite for these groups and solo practitioners. More sp ecifically, the cost measures

and cost benchmarks used to determine the cost composite under the VM are different than the methodology used to calculate financial perfor mance under the Shared Savings Program. In contrast, the GPRO web interface quality measures used in the Shared Savings Program are the same as those used to calculate the quality compos ite of the VM for groups that are not in Shared Savings Program ACOs that report through GPRO. Furthermore, ACOs in the Shared Savings Program report on quality measures on behalf of all the groups and solo practitioners that participate in the ACO, which allows us to ca lculate a single quality composite that can be applied to all participants. We do not have this same capability for the cost composite, which would need to be calculated separately for each group or solo practitioner and thus could create conflicting incentives and add more confusion. By calculating a qua lity composite for groups and solo practitioners that participate in ACOs under the Shared Savings Program we are providing an additional incentive to improve th e quality of care for their benefi ciaries. As stated in section III.N.4.d.1.b., where we discuss the calculation of the cost composite for Shared Savings Program ACO participants, we do not believe it w ould be appropriate to allow groups or solo practitioners to “opt in” to having their VM calcu lated based on the TIN’s, rather than the whole ACO’s, performance. Allowing groups or solo pract itioners to “opt in” to having their own VMCMS-1612-FC 973

calculated could create conflicting incentives and competing priorities between the ACO’s goals and the specific group’s or solo practitioner’s goals . An “opt in” policy would result in Shared Savings Program ACO participants reporting quality data outsid e of the ACO, which is not consistent with the policies of the Shared Savings Program.

Comment: As noted in the section III.N .4.d.1.b., we received a few comments related to scenarios in which a group or so lo practitioner enters or leaves the Shared Savings Program. Commenters pointed out that applying an ACO’s quality performance to groups or solo practitioners that were not in the ACO in th e performance period could discourage groups and solo practitioners from joining an ACO in the pa yment adjustment period if it would mean they would not receive an earned upward adjustment. One commenter indicated that it would not be fair to assess a group or solo practitioner th at was in the Shared Savings Program in the performance period, but is not in the payment adjustment period, without consideration of the incentives in place in the performance period. Th is commenter, however, did not object to the application of “average quality” to groups and solo practitioners in this situation. We also received some general comments that the many different scenarios proposed were confusing and added additional complexity to the VM program. Response: We appreciate the comments that pointed out the potential problems with using participation during the payment adjustme nt period to determine the quality performance of groups and solo practitioners. As stated in the comments and responses in section III.N.4.d.1.b., we agree that using a group or solo pr actitioner’s status in the payment adjustment period could discourage future par ticipation in the Shared Savings Program. Consistent with our response to the cost composite comments, we belie ve that it would be ina ppropriate to ignore the quality performance of a group or solo practi tioner in the performan ce period because they choose to join an ACO in the payment adjustment period, as well as in the opposite scenario (if aCMS-1612-FC 974

group or solo practitioner participated in an AC O in the performance period and then left the ACO in the payment adjustment period). As di scussed in our earlier response, we believe it would be appropriate to use the ACO’s quali ty performance because the group or solo practitioner was part of the AC O during the performance period and should be assessed based on

the incentives that existed dur ing the performance period. Our pr oposal to consider a group or solo practitioner’s participat ion in a Shared Savings Program ACO during the payment adjustment period was intended to be consistent with our existing policy to not “track” or “carry” an individual’s performance from one TIN to another from performance period to payment adjustment period. Given the comments we r eceived on our proposals concerning the cost and quality composites for groups and solo practitioners that participate in an ACO under the Shared Savings Program, we agree that it is preferable to consider a group or solo practitioner’s participation in an ACO during the performan ce period to determine how the VM should be applied. Given that we would have ACO-leve l quality data available for group and solo practitioners that were in an AC O in the performance period, we belie ve this data should be used to calculate a quality co mposite for those groups and solo prac titioners. This is consistent with the policy regarding the cost composite that we are finalizing in section III.N.4.d.1.b of this final rule with comment period, which focuses on the cost and quality performance incentives that existed for the group or solo practitioner in th e performance period, not the payment adjustment period when applying the VM to gr oups and solo practitioners th at are in the Shared Savings Program. As noted above, it is al so consistent with the way in which we have determined participation in the Shared Savings Program for the 2015 and 2016 VM, based on whether the group or solo practitioner participated in the Shared Savings Program during the performance period. Further, as noted in the cost compos ite section III.N.4.d.1.b, util izing the performance period for the purpose of determining whether the group or solo practitioner is a Shared SavingsCMS-1612-FC 975

Program ACO participant eliminates the need for us to calculate preliminary payment adjustment factors prior to the beginning of the payment adjustment period, and then recalculate the payment adjustment factors after the final ACO participation list is completed, as we had proposed to do (79 FR 40506). We are also convi nced by commenters who stated that our proposed policies were too complex. We believe that using a TIN’ s participation in an ACO in the performance period to determine the cost co mposite, while considering the TIN’s status in the payment adjustment period to determine the quality composite, would add unnecessary complexity and inconsistency, especially as new ACOs continue to be established and existing ACOs expand. In the proposed rule (79 FR 40498), we stated that if a group or solo practitioner was in ACO 2 in the performance period and then joined ACO 1 in the payment adjustment period, we would use ACO 1’s quality performance to calcul ate the quality composite for that group or solo practitioner. Although we did not receive specific comments on th is policy, we believe that based on the other comments received and the po licy we are finalizing it would no longer be appropriate to use ACO 1’s quality data to calculate a quality composite for these groups and solo practitioners. Given that in all other scenarios, we are finalizing policies that we will consider the group or solo practitioner’s (as iden tified by taxpayer iden tification number (TIN)) status during the performance period, rather th an the payment adjustment period to determine how the group’s or solo practitioner’s quality and cost compos ite should be calculated, we also believe this is the appropriate approach for gr oups and solo practitioners that move between ACOs. We have previously stated our rationale for using the pe rformance period to determine a

TIN’s association with an ACO a nd we believe that reasoning app lies to this scenario as well. Furthermore, it would be unnecessarily complex to apply a different policy for groups and solo practitioners in this scenario (where the TIN is part of one ACO during the performance periodCMS-1612-FC 976

and a different ACO during the payment adjust ment period) than in the other scenarios previously discussed. After considering the public comments receiv ed, we are finalizing a policy to calculate a quality of care composite score based on th e quality-tiering methodology using quality data submitted by a Shared Savings Program ACO duri ng the performance period and apply the same quality composite to all of the groups and solo practitioners, as identified by TIN, under that ACO. Unlike our proposed policy, which consid ered whether a group or solo practitioner participates in a Shared Savi ngs Program ACO during the payment adjustment period for the VM (for example, CY 2017), our final policy is if a group or solo practitioner par ticipates in a Shared Savings Program ACO during the applicab le performance period (for example, the CY 2015 performance period for the CY 2017 payment adju stment period), then that group or solo practitioner’s quality composite is calculated using the ACO- level quality data from the performance period, regardless of wh ether the group or solo practiti oner participates in a Shared Savings Program ACO during the payment adjust ment period. The VM calculated under this policy will apply to all physicians billi ng under the group’s TIN in the CY 2017 payment adjustment period, and beginning in the CY 2018 payment adjustment period, to all physician and nonphysician eligible profession als billing under the group’s TI N, regardless of whether the professional was part of the group in the performance period. This is consistent with our policy for other groups subject to the VM, in that we will not “track” or “carry” an individual professional’s performance from one TIN to another TIN. Comment: Several commenters requested that we provide further guidance on how groups that leave the Shared Savings Program will be treated under the VM. Specifically one commenter suggested that we cons ider how we would apply the VM in situations in which an ACO dissolves mid-year and does not report quality data. The commenter stated that we shouldCMS-1612-FC 977

ensure that those groups and solo practitioners participating in the ACO are not subject to the automatic downward adjustment. Response: We appreciate commenters raisi ng these questions and concerns. We did not specifically address in the propos ed rule the scenario in whic h a Shared Savings Program ACO does not successfully report on quality as requi red under the Shared Savi ngs Program during the performance period for the VM. We clarify th at we intended to adopt for groups and solo practitioners that participate in a Shared Savings Program ACO th e same policy that is generally applicable to groups and solo pr actitioners that fail to satisfac torily report or participate under PQRS and thus fall in Category 2 and are subj ect to an automatic downward adjustment under the VM in CY 2017 (79 FR 40496 – 40497). We are finalizing this policy for groups and solo practitioners that particip ate in a Shared Savings Pr ogram ACO under §414.1210(b)(2). Consistent with the application of the VM to other groups and so lo practitioners that report under PQRS as described in section III.N.4.c, if the ACO does not successfully report quality data as required by the Shared Savings Program unde r §425.504, all groups and solo practitioners participating in the ACO will fall in Category 2 for the VM and therefore will be subject to a downward payment adjustment as described in sec tion III.N.4.f. We also plan to issue programspecific guidance to provide pa rticipants with more inform ation about how these various situations may be addressed. Our final policy fo cusing on the group or solo practitioner’s status in the performance period will simplify the operati onal issues related to determining the answers to these questions.

(d) Treatment of groups with two to nine elig ible professionals and solo practitioners in the Shared Savings Program. In section III.N.4.c of this final rule with comment period, we discussed our proposal to hold groups with two to nine eligible pr ofessionals and soloCMS-1612-FC 978

practitioners who are in Cate gory 1 harmless from any downwar d adjustments under the qualitytiering methodology for the CY 2017 payment adjust ment period. We proposed to also hold harmless from any downward adjustments groups w ith two to nine eligible professionals and solo practitioners who particip ate in ACOs under the Shared Savings Program during the CY 2017 payment adjustment period based on their si ze during the performance period. We would follow our established process for determining group size, which is described at §414.1210(c). Therefore, to the extent that a quality of care composite can be calculated for an ACO, and the cost composite would be classified as “aver age cost,” groups with 10 or more eligible professionals participating in the Shared Savings Program woul d be subject to an upward, neutral, or downward payment adjustment in CY 2017, and groups with two to nine eligible professionals and solo practitioners would be subject to an upward or neutral payment adjustment in CY 2017. We also proposed that groups and solo practitioners participating in ACOs under the Shared Savings Program would be eligible for the additional upward payment adjustment of +1.0x for caring for high-risk benefi ciaries, as proposed in section III.N.4.f. We proposed to modify §414.1210 to refl ect these proposals.

Comment: We did not receive any comments on these proposa ls specific to the Shared Savings Program. General comments on these proposal s are addressed in sect ion III.N.4.c of this final rule with comment period. Consistent with final policies in this final rule with commen t period to use a group or solo practitioner’s status in the perf ormance period to determine partic ipation in the Shared Savings Program, we are finalizing a policy to hold harmless from any downward adjustments groups with two to nine eligible prof essionals and solo practitioners who participate in ACOs under the Shared Savings Program during the performance period (for example, the CY 2015 performanceCMS-1612-FC 979

period for the CY 2017 payment adjustment period ) based on their size during the performance period. We have modified §414.1210 to reflect these final policies for application of the VM beginning with the CY 2017 payment adjustment pe riod to groups and solo practitioners that participate in an ACO under the Sh ared Savings Program ACO.

(2) Physicians and Nonphysician Eligible Profes sionals that Participat e in the Pioneer ACO Model, the Comprehensive Primary Care (CPC) Initiative, or Other Similar Innovation Center

Models or CMS Initiatives

Section 1115A of the Act auth orizes the Innovation Center to test innovative payment and service delivery models to reduce Medicare , Medicaid, or Children’s Health Insurance Program (CHIP) expenditures, wh ile preserving or enhancing the quality of care furnished to beneficiaries under those programs. Therefore, all models tested by th e Innovation Center would be expected to assess participating entities (for example, providers, ACOs, states) based on quality and cost performance. As noted above , we established a polic y in the CY 2013 PFS final rule with comment period (77 FR 69313) to not apply the VM in CY 2015 and CY 2016 to groups of physicians that are participating in th e Pioneer ACO Model, the CPC Initiative, or in

other Innovation Center initiativ es or other CMS programs which also involve shared savings and where participants make substantial investments to report quality measures and to furnish higher quality, more efficient and effective healthcare.

The Pioneer ACO Model and the CPC Initia tive are scheduled to end on December 31, 2016. Therefore, the relevant performance periods for consideration for participants in these initiatives are CY 2015 for the CY 2017 VM paym ent adjustment period and potentially CY 2016 for the CY 2018 VM payment adjustment period. Under the Pioneer ACO Model, an ACOCMS-1612-FC 980

may consist of practitioners from multiple participating groups and solo practitioners (as identified by their individual TIN/NPI combina tion). Thus, a group practice may consist of one or more eligible professionals who participat e in the Pioneer ACO M odel and other eligible professionals who do not particip ate in the Pioneer ACO Model. In the case of the CPC Initiative, a practice site may participate in the m odel even if one or more other practice sites that use the same TIN does not participate. (a) Application of the VM to participants in the Pioneer ACO Model and CPC Initiative. Beginning with the CY 2017 payment adjustment period, we proposed to apply the VM to physicians and nonphysician eligible professionals in groups w ith two or more eligible professionals and to physicians and nonphysicia n eligible professi onals who are solo practitioners who participate in the Pioneer AC O Model or the CPC Initiative during the relevant performance period in accordance with th e policies described below (79 FR 40500). Comment: The majority of comments we rece ived stated that CMS should not apply the VM to group practices and solo practitioners participating in the Pioneer ACO Model or CPC Initiative. These comments largely mirrored the comments summarized in section III.N.4.d.1.a

of this final rule with comment period regarding the application of the VM to Shared Savings Program participants. A few commenters also suggested that the appl ication of the VM to

Innovation Center initiatives should be waived under section 1115A of th e Act. Additionally, one organization expressed concern that the number of varying appr oaches to calculating the VM in our proposed rule would be too complex to implement and may not create equitable comparisons among Pioneer, CPC, other Innovati on Center model participants, and other individuals and groups under the VM program. This commenter suggested that we exempt group practices and solo practit ioners who participate in th e Pioneer ACO Model until thatCMS-1612-FC 981

model ends. As noted in section III.N.4.d.1.a, a few commenters supported the application of the VM to as many groups and solo practitioners as possible to encourag e value-based change. Response: We are required to apply the VM to all physic ians and groups of physicians beginning no later than January 1, 2017, and we be lieve that alignment of the VM program and the Pioneer ACO Model, CPC Initiative, and othe r similar models emphasizes the importance of quality reporting and quality meas urement, for improvement of the quality of care provided to

Medicare beneficiaries. We understand the concerns presented by these commenters and summarized in section III.N.4.d.1 regarding calcul ation of the cost a nd quality composites under the VM, and we address them below, in sec tion III.N.4.d.2.b of this final rule with comment period. After considering the public comments on th is proposal, we are fi nalizing a policy to apply the VM in the CY 2017 payment adjustment period, to physicians in groups with two or more eligible professionals in wh ich at least one eligible professional participates in the Pioneer ACO Model or the CPC Initiative during the perf ormance period, and to physicians who are solo practitioners that participat e in the Pioneer ACO Model or the CPC Initiative during the performance period. We note that, in response to commenters’ con cerns, we are not finalizing the proposal to apply the VM to nonphysician eligible professiona ls in the CY 2017 payment adjustment period that participate in the Pioneer ACO Model or CP C Initiative. This policy is consistent with the policy for the Shared Savings Program in the CY 2017 payment adjustment period described in section III.M.4.d.1 and for groups and solo practitioners that do not participate in these models or in the Shared Savings Program, as discussed in s ection III.N.4.b of this fi nal rule with comment period.CMS-1612-FC 982

(b) Calculation of the cost and quality co mposite of the VM for Pioneer ACO and CPC Initiative participants.

● For groups and solo practi tioners who participate in th e Pioneer ACO Model or the CPC Initiative during the performance period fo r the VM, we proposed policies for how we would calculate the cost and quality composites in a number of scenarios depending on whether or not all eligible professionals in the group participate in the m odel, whether or not the group or solo practitioner report through PQRS outside of the model, and if so, through which reporting mechanism, and whether or not the group or solo practitioner participate in the Shared Savings Program in the payment adjustment period. Additi onally, we described seve ral alternatives that we considered to the proposed policies. Specifica lly, we described two alte rnatives to Scenario 2 described in the proposed rule (79 FR 40501). Unde r one alternative, for groups that have some eligible professionals participa ting in the model and some eligib le professionals that are not participating in the model, we considered appl ying “average quality” without regard to any PQRS data reported outside of the model. Another alternative we considered was to apply ‘‘average quality’’ to groups wh ere less than 50 percent of all e ligible professionals in the group meet the criteria for satisfactory reporting of da ta on PQRS quality measur es as individuals or satisfactorily participate in a PQRS-qualified clin ical data registry, because we would not have quality data for more than half of the group that we could use to calculate a quality composite. For a detailed description of these scenarios and proposed policies, as we ll as the alternatives considered, we refer readers to the proposed rule at 79 FR 40500-40504. We also provided a summary of these proposals, as Table 57 in the proposed rule (79 FR 40504). We solicited comments on these proposal s and the alternatives considered. Comment: We received comments on our proposal s for calculating the quality and cost composites for Pioneer ACO Model and CPC Initiative participants. As noted in sectionCMS-1612-FC 983

III.N.4.d.2.a of this final rule with comment period, most commenters did not support our proposal to apply the VM to Pione er ACO and CPC participants in general. However, many of

these commenters stated that if the VM were to be applied to these providers, then CMS should classify the cost and quality composites as averag e to avoid sending what they see as conflicting messages about cost and quality benchmarks. Th ese commenters did not make any distinction between the reporting mechanism used when quality data is reported to PQRS outside of the model (for example, GPRO vs. i ndividual reporting). Instead, they argued that we should apply average cost and average quality for all groups and solo practitioners participating in these models because they have already taken on accountability for cost and quality measures, and it would be confusing and unnecessary to hold them to a different se t of measures or benchmarks. The “Innovation Pathway” suggestion referenced in the summary of comments on section III.N.4.d.1 was also recommended for groups and solo practitioners participating in the Pioneer Model and CPC Initiative. A few commenters sugge sted that providers participating in Pioneer or CPC should only be eligible for upward VM ad justments. Some comme nters suggested that groups and solo practitioners shoul d be able to opt-in to having their cost and quality composites calculated as described in the proposed rule. We also received a comment indicating that providers in the Pioneer and CPC models should have their VM calculated the same as any other TIN subject to the VM. Response: We are convinced by commenter s who suggested that groups and solo practitioners in these models shoul d be classified as “average cost ” and “average quality.” In section III.N.4.d.1, we described our rationale for classifying the co st composite as “average” for groups and solo practitioners th at participate in an ACO under the Shared Savings Program. Similar to the Shared Savings Program, the Pione er ACO Model and CPC Initiative use a shared savings methodology that is significa ntly different than the cost measures and benchmarks usedCMS-1612-FC 984

to calculate the cost composite under the VM pr ogram. Because of these significant differences, we are persuaded by commenters who stated that the calculating a cost composite for groups and solo practitioners in these models could create conflicting incentiv es. Moreover, it is challenging to meaningfully assess the quality performance of groups that participate in these models for purposes of calculating a quality composite for the VM given that for many of these groups, some eligible professionals in the group participate in these models while other eligible professionals within the same group do not participate (79 FR 40502) . Although the Pioneer ACO Model uses the same set of quality measures as the Shared Savings Program, this quality data does not necessarily represent all eligible professionals in the group because some do not participate in the model. The CPC Initiative pr esents similar challenges because of groups in which only a subset of eligible professionals may be participating in the model. Because some of the groups with eligible professionals partic ipating in these models could choose to report outside of the model through a PQRS reporting m echanism, we may have quality data for a subset of groups or for a subset of indivi duals within a group, de pending on the reporting mechanism. The policies in our pr oposed rule indicated that we would make use of this quality data when available, however, as noted above , we also considered other options including applying “average quality” to certain groups. We agr ee that it is important for these participants to focus on the cost and quality measures within their respective models and are persuaded by the vast majority of commenters who indicated that these policies could creat e conflicting incentives for model participants and seve ral commenters who stated that they were unnecessarily complex and likely to cause confusion. We do not agree with commenters who suggested giving groups and solo practitioners an opportunity to “opt-in” for the r easons stated in response to

comments on section III.N.4.d.1. We appreciate the support of co mmenters who agreed that applying the VM to groups and solo practitioners in these initiatives would support the VMCMS-1612-FC 985

program goals of improving quality and cost effi ciency. To the extent possible, we intend to provide QRURs showing cost and, where availabl e, quality performance on VM measures, to these groups and solo practitioners to furt her support the goals of the VM program.

Comment: We also received comments on our proposal to calculate the cost composite for groups and solo practitioners who are not in the Shared Savings Program or similar CMS initiative in the payment adjustment year. These commenters stated that groups and solo practitioners should be assessed ba sed on the cost and quality incenti ves that were in place in the performance period, not the payment adjustment period. Under our proposed policies, we would calculate a cost composite for gr oups that participated in Pion eer or CPC in the performance period but did not participate in another similar initiative or the Shared Savings Program in the payment adjustment period. One commenter stated these groups and solo practitioners should be classified as average cost because at least a port ion of their eligible professionals were operating

under a different set of cost measures during the performance period. Response: As noted in section III. N.4.d.1, we are persuaded by commenters who suggested that taking into account the status of the group or solo prac titioner in the payment adjustment period does not fully acknowledge the in centives that existed fo r the group or solo practitioner in the perf ormance period and, consistent with the approach taken for Shared Savings Program participants, we are finalizing a policy that takes into account whether a group or solo practitioner participates in the Pioneer ACO Model or CPC Initiative during the performance period for the VM. As discussed ab ove, we believe the differences in methodology

between the VM cost measures and the methodol ogies used to determine shared savings under

the Pioneer ACO Model and the CPC Initiative are significant and that it would be inappropriate to calculate a cost composite for these groups and solo practitioners. In the proposed rule (79 FR 40502), we stated that for groups and solo practi tioners that participat e in the Pioneer ACOCMS-1612-FC 986

Model or CPC Initiative in the performance peri od and then participate in an ACO under the Shared Savings Program in the payment adjust ment period, we would use the Shared Savings Program ACO’s quality data to calculate the quality composite, or classify the quality composite as average if the ACO did not exist in the perf ormance period. We are modi fying this policy such that groups or solo practitioners who participate in the Pioneer ACO Model or CPC Initiative in the performance period and then participate in an ACO under the Shared Savings Program in the payment adjustment period will also receive “av erage cost” and “average quality”. This is consistent with the policies we are finalizing for the groups and solo practi tioners that participate in an ACO under the Shared Savings Program to consider the group or solo practitioner’s status during the performance period, in order to determine how the VM will be applied. After considering the public comments, we are finalizing a policy that for solo practitioners and groups with at least one eligible professional pa rticipating in the Pioneer ACO Model or CPC Initiative during the performance pe riod, we will classify the cost composite as “average cost” and the quality composite as “average quality” for the CY 2017 payment adjustment period. This policy is similar to the a lternative to scenario 2 we considered in the proposed rule (79 FR 40501), though with a br oader application to address commenters’ concerns about the level of comp lexity in the proposals. We are not finalizing our proposals regarding the requirements for groups and solo practitioners in the Pioneer ACO Model and CPC Initiative to avoid Category 2 and the downw ard payment adjustment. Instead, for the CY 2017 payment adjustment period, the policy to classify the cost composite as “average cost” and the quality composite as “average quality” will apply to all solo practitioners who participate in the

Pioneer ACO Model or the CPC Initiative in the performance period and all groups with at least one eligible professional who par ticipates in the Pioneer ACO Mode l or the CPC Initiative in the performance period. Given the concerns about distra cting from the goals of the models in whichCMS-1612-FC 987

these groups and solo practitioners participate, the complexity of determining whether groups that have some eligible professionals in the model and some who are not in the model successfully reported quality pe rformance data, and the commenters’ requests for a simpler policy, we believe this is an appropriate policy. The VM calculated under this policy will apply to all physicians billing under the group’s TIN in the CY 2017 payment adjustment period re gardless of whether the physician was part of the group in the performance period. This is cons istent with our policy fo r other groups subject to the VM, in that we will not “track” or “carry ” an individual profession al’s performance from

one TIN to another TIN. (c) Treatment of groups of two to nine eligib le professionals and so lo practitioners that participate in the Pioneer ACO Model or CPC Initiative.

In section III.N.4.c of this final rule with comment period, we discussed our proposal to hold groups with two to nine elig ible professionals and solo pract itioners who are in Category 1 harmless from any downward adjustments unde r the quality-tiering methodology for the CY 2017 payment adjustment period. We proposed to also hold harmless from any downward adjustments for CY 2017 groups with two to nine eligible professionals , where one or more eligible professionals participate in the Pioneer ACO Model or the CPC, and solo practitioners who participate in the Pioneer ACO Model or the CPC during the CY 2015 performance period based on their size during the performance period. We would follow our established process for determining group size, which is described at §414.1210(c). We also proposed that groups where one or more eligible professionals part icipate in the Pioneer ACO Model or the CPC during the performance period, and solo practitioners participati ng in the Pioneer ACO Model or the CPC during the performance period would be eligible for the additional upward payment adjustment of +1.0x for caring for high-risk beneficiarie s, as proposed in section III.N.4.f below.CMS-1612-FC 988

Comment: We did not receive comments speci fic to this proposal. The comments we received on our general policy to hold harmless groups of two to nine elig ible professionals and solo practitioners are discusse d in III.N.4.a of this final rule with comment period. Given the modified policy we are finalizing for group practices and solo practitioners participating in the Pioneer ACO Model and CPC In itiative to classify the cost composite as “average cost” and the quality composite as “average quality,” these proposals are no longer

relevant and will not be finalized. (d) In addition, beginning with the CY 2017 payment adjustment period, we proposed to apply the VM to physicians and nonphysician eligib le professionals in groups with two or more eligible professionals and to physicians and nonphysician eligible professionals who are solo practitioners who participate in other similar I nnovation Center models or CMS initiatives during the relevant performance period for the VM in accordance with the proposed policies described

above for the Pioneer ACO Model and the CPC Initiative. We are unable to propose an

exhaustive list of the models and initiatives th at would fall under this category because many of them have not yet been developed. In addition, it is possible that the timeline for implementing some of these new models and initiatives may not coincide with the timeline for rulemaking for the VM. To address these issues, we proposed to rely on the following general criteria to

determine whether a model or initiative would fa ll in this “other similar” category and thus would be subject to the policies described above for the Pioneer ACO Model and the CPC Initiative: (1) the model or initiative evaluate s the quality of care and/ or requires reporting on quality measures; (2) the model or initiative evaluates the co st of care and/or requires reporting on cost measures; (3) participants in the model or initiative receive payment based at least in part on their performance on quality measures and/ or cost measures; (4) potential for conflict between the methodologies used for the VM and the methodologies used for the model orCMS-1612-FC 989

initiative; or (5) other relevant f actors specific to a model or initia tive. We noted that a model or

initiative would not have to satisf y or address all of th ese criteria to be included in this “other similar” category. Rather, the criteria are intended to serve as a general framework for evaluating models and initiatives with regard to the application of the VM to groups and solo practitioners who participate (79 FR 40502). We solicited pub lic comment on these or other appropriate criteria for determining which models or initiatives we should classify as “other similar” models, for the purposes of applying the policies for the Pioneer ACO Model and the

CPC Initiative described above.

Comment: We did not receive any comments on the crite ria proposed to determine “other similar” models, though many of the comments received on our proposals related to the application of the VM to groups and solo prac titioners participating in the Shared Savings Program, Pioneer ACO Model, or CPC Initiative. Response: As stated in our response to comments on the application of the VM to Pioneer ACO and CPC Initiative participants, we are convinced by commenters who suggested that we apply “average cost” and “average qual ity” to these groups and solo practitioners. We believe many of these “other similar” models would be testing new quality measures, reporting methods, or both, and we want to encourage in novation, including standing up new infrastructure to capture performance on quality m easures that could be used in th e VM program in the future.

After consideration of the co mments, we are finalizing our general criteria as proposed for determining if a model or initiative should be classified as an “other similar” model or initiative. We will apply the final policies a dopted for applying the VM to groups and solo practitioners that partic ipate in the Pioneer Model or the CPC Initiative to Innovation Center

models and CMS initiatives that we determine are “similar” based on these criteria.CMS-1612-FC 990

We recognize that the policies we finaliz e for the Pioneer ACO Model and the CPC Initiative might not be applicab le to all of the various models and initiatives that could be developed in future years. If we believe a different approach to a pplying the VM would be appropriate for a model or initiative, we intend to address it in future rulemaking. In addition, if we were to determine that a model or initiative falls under this “other similar” category based on the general criteria, we will provide notice to pa rticipants in the model or initiative through the methods of communication that are typical ly used for the model or initiative. Additionally, consistent with our final pol icies for the Pioneer ACO Model and CPC Initiative, Shared Savings Program, and groups and solo practitioners that do not participate in these programs or models, we will not apply th e VM to nonphysician eligible professionals in

similar Innovation Center models or CMS initiat ives in the CY 2017 payment adjustment period. We modified §414.1210 to reflec t all of these policies. In addition to the comments described above, we received a few comments that were outside the scope of what was proposed in this rule:

Comment: One commenter stated that ACOs should have an opportunity to receive confidential reports on their pe rformance on all Medicare FFS be neficiaries – not just MSSPattributed beneficiaries – thr ough the Physician Feedback Progra m prior to application of the VM program. This commenter also stated th at CMS should reduce th e administrative burden associated with the “opt out” process for data sharing for Shared Savi ngs Program ACOs. Other

commenters stated that CMS s hould adjust the financial benchmarks for ACOs based on VM adjustments. Response: We appreciate the input from th ese commenters but believe these suggestions are outside the scope of this rule. Data sharing policies and fi nancial benchmarking methodologies for the Medicare Shared Savings Progr am are described in the Final Rule for thatCMS-1612-FC 991

program released in November 2011. The rule can be accessed http://www.gpo.gov/fdsys/pkg/FR-2011-11-02/pdf/ 2011-27461.pdf. Information on the Pioneer ACO Model, can be found here: http://innova tion.cms.gov/initiatives/Pioneer-ACO-Model/. e. Clarification Regarding Treatment of Non-a ssigned Claims for Non-Participating Physicians In the CY 2013 PFS final rule with comment pe riod in which we established a number of key policies for the VM, we stated that we ha d received few comments on our proposal to apply the VM to the Medicare paid amounts for the ite ms and services billed under the PFS so that beneficiary cost-sharing or coinsurance w ould not be affected (77 FR 69309). These commenters generally agreed with the proposal to apply the VM to the Medicare paid amounts

for the items and services billed under the PFS at the TIN level so that beneficiary cost-sharing would not be affected. Therefore, we fina lized this policy and accordingly established a definition of the VM at §414.1205 that was cons istent with the propos al and the statutory requirement to provide for differential payment to a physician or a group of physicians under the fee schedule based upon the quality of care furnis hed compared to cost during a performance period. We continue to believe that it is important that beneficiary cost-sha ring not be affected by the VM and that the VM should be applied to the amount that Medicare pays to physicians. However, in previous rulemaking, we did not dire ctly address whether th e VM would be applied to both assigned services for which Medicare makes payment to the physician, and to nonassigned services for which Medicare makes pa yment to the beneficiary. Participating physicians are those who have signed an agreemen t in accordance with se ction 1842(h)(1) of the Act to accept payment on an assignment-related ba sis for all items and services furnished to Medicare beneficiaries. In other words, part icipating physicians agree to accept the Medicare approved amount as payment in full and to charge the beneficiary only the Medicare deductibleCMS-1612-FC 992

and coinsurance amount. In contrast, non-particip ating physicians have not signed an agreement to accept assignment for all services furnished to be neficiaries, but they can still choose to accept assignment for individual services. If they c hoose not to accept assignment for particular services, non-participating physicians can char ge the beneficiary more than the Medicareapproved amount, up to a limit called the “limiting ch arge.” The limiting charge is defined at section 1848(g)(2)(C) of the Ac t as 115 percent of the recognized payment amount for nonparticipating physicians. In contrast, if a non-participating physician chooses to accept assignment for a service, they receive paymen t from Medicare at the approved amount for nonparticipating physicians, which is 95 percent of the f ee schedule amount. Over 99 percent of Medicare physician servi ces are billed on an assignment re lated basis by both participating and non-participating phys icians and other suppliers, with th e remainder billed as non-assigned services by non-particip ating physicians and other suppliers. For assigned claims, Medicare makes payment directly to the physician. In accordance with section 1848(p)(1) of th e Act and the regulations at §414.1205 and §414.1210(a), the VM should be applied to assigned claims. However, for non-assigned claims, the limiting charge (the amount that the physician can bill a beneficiary for a non-assigned se rvice) would not be affected if the VM were applied to the claim. This is so, because for non-assigned claims, application of the VM would not affect the limiting charge . Rather, Medicare makes payment for the nonassigned services directly to the beneficiary and the physician receives all payment for a nonassigned service directly from the beneficiary. If the VM were to be applied to non-assigned services, then the Medicare payment to a bene ficiary would be increased when the VM is positive and decreased when the VM is negative. The application of the VM to non-assigned claims would therefore directly affect beneficiarie s and not physicians, contrary to our intent as discussed in previous rulemaking (77 FR 69309). On that basis, we proposed to clarify that weCMS-1612-FC 993

would apply the VM only to assigned services a nd not to non-assigned se rvices starting in CY 2015 (79 FR 40504). We do not expect this propos ed clarification, to not apply the VM to nonassigned claims, would be likely to affect a physician’s decision to participate in Medicare or to otherwise accept assignment for a particular claim. This is because the amount that a provider is entitled to receive from the beneficiary for non-a ssigned claims is not affected by whether or not the VM is applicable to non-assigned claims. Additionally, to the extent our proposal to expand application of the VM to nonphysic ian eligible professionals is finalized, we would likewise apply the VM only to services billed on an assignment-related basis and not to non-assigned

services. We invited comments on this proposed clarification. The following is summary of the comments we received on this pr oposed clar ification. Comment: We received relatively few comments on this technical issue. For those that did comment, nearly all agreed with the proposed clarification and agreed it is important that beneficiary cost-sharing not be affected by the VM, and that the VM should be applied to the amount that Medicare pays to physicians. So me commenters requested a similar policy be applied to the payment adjustments for PQRS and EHR Meaningful Use. A commenter opposed the proposed clarification, enc ouraging CMS to support non-participating providers by applying the value modifier adjustment to non-assigned claims at the gr oup practice level (TIN), and to

evaluate alternative solutions to paying providers other than at the claim level. Response: We appreciate re ceiving the comments that supported this technical clarification. However, we are unable to agree with the commente r that suggested an alternative approach to apply the VM to claims submitte d by non-participating physicians. As explained above and in the proposal, the application of th e VM to non-assigned claims by non-participating physicians would directly affect beneficiaries and not physicians , contrary to our intent. However, we further clarify that the VM will apply to all assigned claims, including thoseCMS-1612-FC 994

submitted by both participating and non-participating physicians , and nonphysician eligible professionals to the extent the VM is applie d to them. Therefore, the VM will affect nonparticipating physicians to the extent that they submit assigned claims. With regard to the comment that a simila r policy for non-assigned claims be applied to the PQRS and EHR meaningful use adjustments, we believe the comment is outside of the scope of the proposed rule, although we note that the VM is quite different from the PQRS and EHRmeaningful use adjustments, which apply to th e Medicare allowed amou nt rather than the Medicare paid amount. After considering the public comments, we ar e finalizing the proposed clarification to not apply the VM to non-assigned claims for non-part icipating physicians, and nonphysician eligible professionals to the extent th e VM is applied to them. f. Payment Adjustment Amount Section 1848(p) of the Act does not specify th e amount of payment that should be subject to the adjustment for the VM; however, secti on 1848(p)(4)(C) of the Ac t requires the VM be implemented in a budget neutral manner. Budget neutrality means that payments will increase for some groups and solo practitioners based on high performance and decrease for others based on low performance, but the aggregate expected amount of Medicare spending in any given year for physician and nonphysician eligible professi onal services paid under the Medicare PFS will not change as a result of application of the VM.

In the CY 2014 PFS final rule with comme nt period (78 FR 74770-74771), we adopted a policy to apply a maximum downward adjustment of -2.0 percent for the CY 2016 VM for those groups of physicians with 10 or more eligible pr ofessionals that are in Category 2 and for groups of physicians with 100 or more eligible professionals that are in Category 1 and are classified as low quality/high cost groups.CMS-1612-FC 995

In the CY 2013 PFS final rule with comment period, we adopted a modest payment reduction of -1.0 percent for groups of physicians in Category 1 that elec ted quality tiering and were classified as low qualit y/high cost and for groups of phys icians in Category 2 (77 FR 69323-24). Although we received co mments suggesting that larger payment adjustments (both upward and downward) would be necessary to mo re strongly encourage quality improvements, we finalized our proposed adjustments as we believed they better ali gned with our goal to gradually phase in the VM. However, we noted that as we gained experience with our VM methodologies we would likely consider ways to increase the amount of payment at risk, as suggested by some commenters (77 FR 69324).

We believe that we can increase the amount of payment at risk because we can reliably apply the VM to groups with two or more eligible professionals and to so lo practitioners in CY

2017 as discussed in section III.N.4.a of this fi nal rule with comment pe riod. Therefore, we proposed to increase the downward adjust ment under the VM by doubling the amount of payment at risk from -2.0 percent in CY 2016 to -4.0 percent in CY 2017 (79 FR 40505-40506). That is, for CY 2017, we proposed to apply a -4 .0 percent VM to groups with two or more eligible professionals and solo pr actitioners that fall in Category 2. In addition, we proposed to increase the maximum downward adjustment under the quality-tieri ng methodology in CY 2017 to -4.0 percent for groups and solo practitioners cl assified as low quality/high cost and to set the adjustment to -2.0 percent for groups and solo practitioners classified as either low quality/average cost or average quality/high cost. However, as discussed in section III.N.4.c of this final rule with comment period, we proposed to hold solo practitione rs and groups with two to nine eligible professionals that are in Category 1 harmless from any downward adjustments under the quality-tiering methodology in CY 2017. C onsistent with our previous policy, we note that the estimated funds derived from the applic ation of the downward adjustments to groups andCMS-1612-FC 996

solo practitioners in Category 1 and Category 2 would be available to all groups and solo practitioners eligible for VM upw ard payment adjustments. Accordingly, we also proposed to increase the maximum upward adjustment unde r the quality-tiering methodology in CY 2017 to +4.0x for groups and solo practitioners classifi ed as high quality/low cost and to set the adjustment to +2.0x for groups and solo practitioners classified as either average quality/low cost or high quality/average cost (79 FR 40505). We also proposed to continue to provide an additional upward payment adjustment of +1.0x to groups and solo practi tioners that care for high-risk beneficiaries (as evidenced by the averag e HCC risk score of the attributed beneficiary population). Lastly, we propos ed to revise §414.1270 and §414.1275(c) and (d) to reflect the changes to the payment adjustments under the VM for the CY 2017 payment adjustment period. Table 87 shows the proposed quality-tiering pa yment adjustment amounts for CY 2017 (based on CY 2015 performance). We believe that th e VM amount differentiates between cost and quality-tiers in a more meaningf ul way. We solicited comments on all of these proposals. TABLE 87: Proposed CY 2017 VM Payment Adjustment Amounts Cost/Quality Low Quality Aver age Quality High Quality

Low Cost +0.0% +2.0 x* +4.0x* Average Cost -2.0% +0.0% +2.0x* High Cost -4.0% -2.0% +0.0% * Groups and solo practitioners eligible for an additio nal +1.0x if reporting Physician Quality Reporting System quality measures and average beneficiary risk score is in the top 25 percent of all beneficiary risk scores. The following is summary of the comments we received on all these proposals. Comment: The majority of the comments we re opposed to our proposals to increase the downward payment adjustments from CY 2016 to CY 2017 for groups and solo practitioners that fall in Category 2 and those that are low qua lity/high cost under the quality-tiering methodology to -4.0 percent. Commenters expressed their be lief that the changes are aggressive. Several

commenters indicated that CY 2017 will be th e first year that many physicians and allCMS-1612-FC 997

nonphysician eligible professionals will be subj ect to the VM, and therefore, recommended maintaining the maximum downward payment adju stment at -2.0 percent for Category 2 and those that are low quality/high cost under the quality-tiering me thodology. Commenters indicated that many of these groups and solo pr actitioners have not ye t received their QRURs; therefore, it would be prematur e to raise the adjustment amo unt until all groups and solo practitioners have applicable cost and quality metrics and have had an opportunity to participate in the PQRS and VM programs. Commenters indicated that CMS should not increase the amount of payment at risk under quality-tieri ng and for Category 2 without providing an opportunity for both providers and CMS to understand the implications of th e current policies as no group has had experience with the VM since it will be implemented in CY 2015. Other commenters suggested that groups and solo practitioners will have little time to fully understand their baseline performance under the VM. They suggested by delaying the increase of the maximum penalty, CMS would gain experience with applying the VM to a broader variety of groups, and that groups and solo practitione rs would increase their understanding of the methodology used to calculate the VM and review their QRURs. Few commenters suggested

that if CMS is concerned about PQRS reporting, then it should sepa rate the amount at risk for not reporting under the PQRS (Category 2) fr om the amount at risk under quality-tiering (Category 1) and that these adjustments should not be at the same level.

Other commenters noted that the cumulative im pact of penalties for PQRS, EHR, and the VM would add up to a potential -9.0 percent adjustment to Medi care payments and expressed that this cumulative impact w ould be overly burdensome. One commenter indicated that the proposed changes would occur in a post-sequester payment environment where providers already experience a -2.0 percent reduction in Medicare payment. Some comme nters indicated it was unfair to hold solo practitioners a nd groups with two to nine eligib le professionals at -4.0 percentCMS-1612-FC 998

for the first year of the VM when groups with of 10 to 99 eligible professionals and groups with 100 or more eligible professionals EPs were at risk for only -2.0 percent and -1.0 percent respectively in their first year of the VM. These commenters suggested that we reduce their Category 2 downward payment adjustment for groups and solo practitione rs during their first year in the VM. By contrast, some supported all of our VM payment adjustment proposals and expressed their belief that a -4.0 percent downward adjust ment and +4.0x upward adjustment factor was not sufficient to incentivize physicia ns to improve quality. A few of these commenters suggested

that the amount at risk shoul d eventually be approximately 10.0 percent and that CMS should create a plan in the final rule to continually increase the weight of the VM over time. One commenter noted that there is evidence in the pr ivate sector that higher incentives and penalties have a great impact on quality improvement. Response: We acknowledge the commenters’ concerns about doubling the amount of payment at risk from -2.0 percent in CY 2016 to -4.0 percent in CY 2017 under the VM. However, the literature documents a positive correlation between physician participation in quality improvement activities and the extent of the payment adjustment. 22 We agree with the commenters who suggested that smaller groups shoul d be subject to a more gradual phase-in of the VM’s application to them, consistent w ith the experience of the larger groups. We acknowledge that our proposal woul d have held solo practitioners and groups with two to nine eligible professionals in Categor y 2 at risk for up to a -4.0 percent payment adjustment for the first year of the VM when groups with of 10 to 99 eligible professionals and groups with 100 or more eligible professionals EPs were at risk fo r only -2.0 percent and -1.0 percent respectively in

22 Francois S. de Brantes & B. Guy D’Andrea. Physicia ns Respond to Pay-for-Perf ormance Incentives: Larger Incentives Yield Greater Participation. Am. J. of Ma naged Care. 2009. 15,305-310. With regard to hospital participation, this correlation has been documented. Rachel M. Werner, et al. The Effect of Pay-For-Performance In Hospitals: Lessons for Quality Improvement. Health Affairs. 2011. 30,690-698.CMS-1612-FC 999

the first year that the VM applied to them. In light of these comments, we agree that a smaller increase in the maximum amount of payment at risk for groups with two to nine eligible professionals and solo practiti oners would be consistent with our stated focus on gradual implementation and would allow small groups and solo practitioners to gain more experience with the QRURs and the applicati on of the VM. Therefore, we ar e finalizing -2.0 percent as the maximum amount of payment at risk in CY 2017 for groups with two to nine eligible professionals and solo practitioners. Specifi cally, in CY 2017, for groups with two to nine eligible professionals and solo practitioners, we will apply a -2.0 percent VM to a group or solo practitioner that falls in Category 2. We note that, as discussed in section III.N.4.c of this final rule with comment period, we are finalizing our proposal to hold solo practitioners and groups with two to nine eligible pr ofessionals that are in Categor y 1 harmless from any downward adjustments under the quality-ti ering methodology in CY 2017, if cl assified as low quality/high cost, low quality/average cost, or average quality/high cost. Add itionally, for groups with two to nine eligible professionals and solo practitioners, we are finaliz ing a policy to set the maximum upward adjustment under the quali ty-tiering methodology in CY 2017 to +2.0x if a group or solo practitioner is classified as hi gh quality/low cost and set the ad justment to +1.0x if a group or solo practitioner is classified as either averag e quality/low cost or hi gh quality/average cost. Table 88 shows the final quality-tiering paymen t adjustment amounts for CY 2017 (based on CY 2015 performance) for groups with two to nine elig ible professionals and solo practitioners. For groups with ten or more eligible prof essionals, we are finalizing the payment adjustments as proposed for CY 2017 (79 FR 40505-40506). As stat ed in the proposed rule (79 FR 40505), we believe that we can increase the amount of payment at risk because groups of this size will have had sufficient experience with th e VM prior to the CY 2017 payment adjustment period. By CY 2017, groups with 10 or more elig ible professionals will have had at least oneCMS-1612-FC 1000

year experience under the VM program. As stat ed in the CY 2014 PFS final rule with comment period (78 FR 74769), on September 16, 2013, we made available to all groups of 25 or more eligible professionals an annual QRUR based on 2012 data to help groups estimate their quality and cost composites. As discussed in section III. N.4.a. of this final rule with comment period, in September 2014, we made available QRURs based on CY 2013 data to all groups of physicians and physicians who are solo prac titioners. We believe that groups of 10 or more eligible professionals will have had adequate data to improve performance on the quality and cost

measures that will be used to calculate the VM in CY 2017. As a resu lt, we believe it is appropriate to increase the amount of payment at risk for groups with ten or more eligible professionals in CY 2017.

Consequently, for CY 2017, we will apply a - 4.0 percent VM to groups with ten or more eligible professionals that fall in Category 2. In addition, we will se t the maximum downward adjustment under the quality-tiering methodology in CY 2017 to -4.0 percent for groups with ten or more eligible professionals cl assified as low quality/high cost and set the adjustment to -2.0 percent for groups with ten or more eligible profe ssionals classified as either low quality/average cost or average quality/high cost. We will also set the maximum upward adjustment under the quality-tiering methodology in CY 2017 to +4.0x for groups with ten or more eligible professionals classified as high quality/low cost and set the adju stment to +2.0x for groups with ten or more eligible professionals classified as either average quality/low cost or high quality/average cost. Table 89 shows the final quality-tiering payment adjustment amounts for CY 2017 (based on CY 2015 performance) for groups with ten or more eligible professionals. We are also finalizing our proposal to conti nue to provide an additional upward payment adjustment of +1.0x to groups with two or more e ligible professionals and solo practitioners thatCMS-1612-FC 1001

care for high-risk beneficiaries (as evidenced by the average HCC risk score of the attributed beneficiary population). Las tly, we are finalizing the revisions at §414.1270(c) and §414.1275(c) and (d) to reflect the payment adju stments under the VM for the CY 2017 payment adjustment period. Tables 88 and 89 show the quality-tiering payment adjustment amounts for CY 2017 (based on CY 2015 performance). We belie ve that these final policies will alleviate

commenters’ concern that our proposals were too aggressive for smaller groups and solo practitioners that are new to the VM in CY 2017, while continuing the gradual phase-in of the VM for groups with ten or more eligible prof essionals with an emphasis on the importance of reporting under the PQRS program and improving the quality and efficiency of services provided

to Medicare beneficiaries.

TABLE 88: Final CY 2017 VM Payment Adjustment Amounts for Groups with Two to Nine Eligible Professional s and Solo Practitioners Cost/Quality Low quality Average quality High quality Low cost +0.0% +1.0x* +2.0x* Average cost +0.0% +0.0% +1.0x* High cost +0.0% +0.0% +0.0% * Groups and solo practitioners eligible for an additiona l +1.0x if reporting measures and average beneficiary risk score is in the top 25 percent of all beneficiary risk scores, where ‘x’ represents the upward payment adjustment factor. TABLE 89: Final CY 2017 VM Payment Adjus tment Amounts for Groups with Ten or More Eligible Professionals Cost/Quality Low quality Average quality High quality Low cost +0.0% +2.0x* +4.0x* Average cost -2.0% +0.0% +2.0x* High cost -4.0% -2.0% +0.0% * Groups eligible for an additional +1.0x if reporting meas ures and average beneficiary risk score is in the top 25 percent of all beneficiary risk scores, where ‘x’ re presents the upward payment adjustment factor.

Consistent with the policy a dopted in the CY 2013 PFS final rule with comment period (77 FR 69324 through 69325), the upward payment adju stment factor (“x” in Tables 88 and 89)CMS-1612-FC 1002

will be determined after the performance period has ended based on the aggregate amount of downward payment adjustments. We noted in the proposed rule that the estimated funds derived from the application of the downward adjustments to groups and solo practitioners in Category 1 and Category 2 would be available to all groups and solo practitioners eligible for VM upward payment adjustments (79 FR 40504). In section III.N.4.d of the proposed rule ( 79 FR 40506), we discussed our proposal to apply the VM to physicians in groups with two or more eligible professionals and to physicians who are solo practitioners that participate in the Shared Savings Program during the payment adjustment period beginning with the CY 2017 paym ent adjustment period. We noted in the CY 2015 PFS proposed rule that will have the final list of ACOs that will participate in the Shared Savings Program during the payment adjustment pe riod and their participan t TINs during the late fall prior to the beginning of the payment adjust ment period (for example, the late fall of CY 2016 prior to the CY 2017 payment adjustment peri od) (79 FR 40506). We al so noted that this final list may not be available until after th e beginning of the payment adjustment period. Therefore, we proposed to calcula te preliminary payment adjustme nt factors (“x” in Table 87) prior to the beginning of the payment adjustment period, and subsequently finalize the payment adjustment factors after the final ACO participa tion list is completed. We note that the final payment adjustment factors may be updated depe nding on the outcome of the informal inquiry process described later at s ection III.N.4.i of this fina l rule with comment period. We did not receive any comm ents on these proposals.

As discussed in section III.N.4.d of this fina l rule with comment pe riod, we are finalizing a policy to use the performance period to de termine which groups and solo practitioners participate in the Shared Savings Program fo r purposes of calculating their VM in CY 2017. Therefore, we are not finalizi ng our proposal to calculate pr eliminary payment adjustmentCMS-1612-FC 1003

factors (“x” in Tables 88 and 89) prior to th e beginning of the payment adjustment period, and then recalculating the payment adjustment factors after the final ACO participation list is completed. However, we are finalizing our propos al that we may update the payment adjustment factors, depending on the outcome of the informal inquiry process described later at section

III.N.4.i of this final rule with comment period. g. Performance Period

In the CY 2014 PFS final rule with comme nt period (78 FR 74771 through 74772), we adopted a policy that performance on quality a nd cost measures in CY 2015 will be used to calculate the VM that is applie d to items and services for which payment is made under the PFS during CY 2017. Accordingly, we added a new pa ragraph (c) to §414.1215 to indicate that the performance period is CY 2015 for VM adjustments made in the CY 2017 payment adjustment period. h. Quality Measures

In the CY 2014 PFS final rule with co mment period (78 FR 74773), we aligned our policies for the VM for CY 2016 with the PQRS group reporting mechanisms available to groups in CY 2014 and the PQRS reporting mech anisms available to individual eligible professionals in CY 2014, such that data that groups submit for qual ity reporting purposes through any of the PQRS group reporting mechanis ms in CY 2014 and the data that individual eligible professionals submit th rough any of the individual PQ RS reporting mechanisms in CY 2014 will be used for calculating th e quality composite under the qua lity-tiering approach for the VM for CY 2016. Moreover, all of the quality m easures for which groups and individual eligible professionals are eligible to re port under the PQRS in CY 2014 w ould be used to calculate the VM for a group for CY 2016 to the extent the group or individual eligible professionals in the group submits data on such measure in accordance with our 50 percent threshold policy (78 FRCMS-1612-FC 1004

74768). We also noted that, in accordance with 42 CFR 414.1230, thr ee additional quality measures (outcome measures) for groups subject to the VM will continue to be included in the quality measures used for the VM in CY 2016. Thes e measures are: (1) a composite of rates of potentially preventable hospital admissions for heart failure, chroni c obstructive pulmonary disease, and diabetes; (2) a composite rate of potentially preventable hospital admissions for dehydration, urinary trac t infections, and bacterial pneumonia; and (3) rates of an all-cause hospital readmissions measure (77 FR 69315).

PQRS Reporting Mechanisms: It is important to continue to ali gn the VM for CY 2017 with the requirements of the PQRS, because quality reporting is a necessary component of quality improvement. We also seek not to plac e an undue burden on eligible professionals to report such data. Accordingly, for purposes of the VM for CY 2017, we proposed to continue to

include in the VM all of the PQRS GPRO reporting mechanisms available to groups for the PQRS reporting periods in CY 2015 and all of the PQRS reporting mechanisms available to individual eligible professionals for the PQ RS reporting periods in CY 2015. These reporting

mechanisms were described in Tables 21 thr ough 49 of the proposed rule (79 FR 40404). PQRS Quality Measures: We proposed to contin ue to use all of the quality measures that are available to be reported under these variou s PQRS reporting mechanisms to calculate a group or solo practitioner’s VM in CY 2017 to the extent that a group (or individual eligible professionals in the group, in the case of the “50 percent option”) or so lo practitioner submits data on these measures. These PQRS quality m easures were described in Tables 21 through 49 of the proposed rule (79 FR 40404). We proposed that groups with two or more elig ible professionals would be able to elect to include the patient experien ce of care measures collected through the PQRS CAHPS surveyCMS-1612-FC 1005

for CY 2015 in their VM for CY 2017 (79 FR 40506) . We also proposed to continue to include

the three outcome measures in §414.1230 in the quality measures used for the VM in CY 2017. For groups that are assessed under the “50 perc ent option” for the CY 2017 VM, we proposed to calculate the group’s performance rate for each measure reported by at least one eligible professional in the group by combining the weight ed average of the performance rates of those eligible professionals re porting the measure. We also proposed for groups that are assessed under the “50 percent option” for the CY 2017 VM to cl assify a group’s quality composite score as ‘‘average’’ under the qualit y-tiering methodology, if all of the e ligible professionals in the group satisfactorily participate in a PQRS qualified clin ical data registry in CY 2015 and we are unable to receive quality performance data for those eligib le professionals. We wish to clarify that in this proposal, the phrase “all of the eligible prof essionals in the group” re fers to the at least 50 percent of eligible professionals in the group who repor t as individuals unde r PQRS. In other words, we proposed for groups that are assesse d under the “50 percent option” for the CY 2017 VM, where all of the eligible professionals in the group who report as individuals under PQRS do so by satisfactorily participating in a PQRS qu alified clinical data re gistry in CY 2015, and we are unable to receive quality performance data for those eligible professionals, then we would classify the group’s quality composite score as ‘‘average’’ under the quality-tiering methodology. If some EPs in the group report data us ing a qualified c linical data registry and we are unable to obtain the data, but other EPs in the group repor t data using the other PQRS reporting mechanisms for individuals, we woul d calculate the group’s score based on the reported performance data that we obtain thr ough those other mechanisms (79 FR 40507). Although we finalized policies in the CY 2014 fi nal rule with comment period that would allow groups assessed under th e “50 percent option” to have data reported through a PQRS qualified clinical data registry in CY 2014 used for the purpose s of their CY 2016 VM to theCMS-1612-FC 1006

extent performance data are available, we noted th at we did not directly address the issue of how we would compute the national benchmarks fo r these measures. Under §414.1250, benchmarks for the quality of care measures for the VM are th e national mean performance rate for a measure during the year prior to the pe rformance period. In the CY 2013 PFS final rule (77 FR 69322), we finalized a policy that if a measure is new to the PQRS, we will be unable to calculate a benchmark and performance on that measure will therefore not be included in the quality composite. Consistent with these existing policies , we proposed to not in clude in the VM quality composite those measures reported through a PQRS qualified clinical data registry that are new to PQRS (in other words, measures that were not previously reported in PQRS) (79 FR 40507). This policy would apply beginning with the meas ures reported through a PQ RS qualified clinical data registry in the CY 2014 performance peri od for the CY 2016 payment adjustment period. We welcomed public comme nt on this proposal. We noted that the PQRS administrative claims option described in §414.1230, is no longer available through PQRS (79 FR 40507). However, we are clarifying that the three claims-based outcome measures described in § 414.1230, are still used in ca lculating the quality composite for purposes of the VM. We proposed to clarify that we calculate benchmarks for those outcome measures described in §414.1230 using the national mean for a measure's performance rate during the ye ar prior to the performance period in accordance with our regulation at §414.1250(b) (79 FR 40507). We we lcomed public comment on this proposal. The following is summary of the comme nts we received on these proposals. Comment: Several commenters supported the al ignment of VM with PQRS requirements. Other commenters, however, raised concerns about the lack of applicable quality measures for multiple specialties and nonphysician eligible prof essionals, which they believe could result in an automatic downward payment adjustment for prof essionals who are unable to report. SeveralCMS-1612-FC 1007

commenters also suggested CMS should include measures in the VM only after physicians had reported on the measures under PQRS for at l east a year. Several commenters supported our proposal to continue our existi ng VM benchmarking policy for measures that are new to PQRS or reported via a Qualified Clin ical Data Registry (QCDR). Se veral commenters supported our proposal to allow optional reporti ng of patient experien ce of care measures for groups of two or more physicians. However several commenters urged us to consider additional patient experience measures that are re levant to beneficiaries using specific Medicare benefits. One commenter suggested that CAHPS data should be collected throughout the year, allowing providers to prioritize and monitor the effectiveness of improvement efforts, especially as patient experience of care data will be incorporated into the VM in CY 2017. One commenter suggested that the patient experience of care measures s hould be optional for quality tiering for the CY 2017 VM, as the 2013 GPRO web participants are still awaiting the resu lts of the survey

administration. A number of co mmenters stated that CMS shoul d not make patient experience measures a required component of the VM in the future. Response: PQRS measures are highly reliabl e measures for understanding the health and

functional status of beneficiar ies after treatment by a particip ating group or solo practitioner. 23 In previous rulemakings we have committed to expanding the specialty measures available in PQRS in order to more accurately measure th e performance on quality of care furnished by specialists and we reaffirm our commitment to using measures of performance across specialties that are reliable and valid for the VM pr ogram (77 FR 69315; 78 FR 74773). Moreover, we believe group reporting can ameliorate the commen ters’ concerns that the current set of PQRS measures does not capture all of the clinical care that some specialists and sub-specialists

23 Mathematica Policy Research, “Exper ience Report for the Performance Year 2012 Quality and Resource Use Reports.” (January 8, 2014).CMS-1612-FC 1008

furnish. We also continue to believe that ali gnment with the PQRS progr am is an important goal for the VM, because it minimizes burden on provide rs and encourages widespread participation in quality reporting.

As we stated in section III.N.4.a of this fi nal rule with comment period, where a group or solo practitioner falls in Categor y 1 under the VM (that is, meets the criteria to avoid the CY 2017 PQRS payment adjustment), but the group or solo practitioner does not have at least 20 cases for each PQRS measure on which it reports as required for inclusion in the quality composite of the VM, the group or solo practitio ner’s quality composite score would be based on

the three claims-based outcome measures de scribed at §414.1230, provide d that the group or solo practitioner has at least 20 ca ses for at least one of the claims-based outcome measures. As

discussed in section III.N.4.h of this final rule with comment pe riod, eligible professionals and groups concerned about the lack of specialty measures to m eet PQRS reporting requirements should note that PQRS has a Measure Appli cability Validation (MAV) process. MAV determines PQRS incentive eligibility for eligib le professionals and gr oups reporting less than

nine measures across three domains or nine or more across less than three domains. We recommend that commenters refer to the Measure Application Validation (MAV) Process to

alleviate concerns that lack of applicable measures would result in an automatic downward adjustment under the VM . http://www.cms.gov/Medicare/ Quality-Initiatives-PatientAssessmentInstruments/PQRS/Downloads/2014_PQRS_ Claims_MeasureAppli cabilityValidation_12132013 .zip. Also, please refer to secti on III.K.2 of this final rule w ith comment period for the final 2017 policies for MAV and the criteria for satis factory reporting for the 2017 PQRS payment adjustment. With regard to the commenters’ suggestion th at the VM should include only measures onCMS-1612-FC 1009

which physicians have reported under PQRS fo r at least one year, we note that we are maintaining the policy set forth in §414.1250 that benchmarks for the quality of care measures are the national mean of a measure’s performan ce rate during the year pr ior to the performance period. Measures reported through a PQRS qualified c linical data registry that are new to PQRS would not be included in the quality composite for the VM because we would not be able to

calculate benchmarks for them. We acknowledge the in terest in ensuring that physicians report on measures for at least one year before they are included in the VM. Ou r current policy achieves that end by precluding the use of measures for which no benchmarking data is available. We acknowledge the comments sugge sting that CMS expand the da ta collected on the patient experience of care (CAHPS) measures and note that we seek to align with the PQRS program in order to minimize reporting burden and align incentives across CMS incentive payment programs. We will consider these suggestions for any future refinements to the patient experience measures included in the PQRS pr ogram and the VM. CMS will provide survey results and post benchmarks for the patient experi ence of care measures; this data as well as the survey questions that can be accessed on the CMS website can be utilized to prioritize performance improvement efforts. We also acknowledge the commenters’ concerns with expansion of mandatory CAHPS inclusion in th e VM and note that we would propose any such policy change through future no tice and comment rulemaking.

After consideration of the co mments, we are finalizing our proposal to use all of the quality measures that are available to be reported under these va rious PQRS reporting mechanisms to calculate a group or solo practitioner’s VM in CY 2017, to the extent that a group (or individual eligible professionals in the group, in the case of the “50 percent option”) or solo practitioner submits data on these measures. We are finalizing our polic y that groups with two or more eligible professionals can elect to include the patient experience of care measuresCMS-1612-FC 1010

collected through the PQRS CAHPS survey fo r CY 2015 in their VM for CY 2017. We are finalizing our policy to conti nue to include the three outco me measures in §414.1230 in the quality measures used for the VM in CY 2017. We are finalizing our policy that for groups that are assessed under the “50 percent option” for the CY 2017 VM, we will calculate the group’s performance rate for each measure reported by at least one eligible pr ofessional in the group by combining the weighted average of the perfor mance rates of those e ligible professionals reporting the measure.

We are finalizing our policy at §414.1270(c)(4) that, for groups that are assessed under the “50 percent option” for the CY 2017 VM, where all of the eligible pr ofessionals in the group who report as individuals under PQRS do so by sa tisfactorily participating in a PQRS qualified clinical data registry in CY 2015, and we are unable to receive quality performance data for those eligible professionals, then we will cl assify the group’s quality composite score as ‘‘average’’ under the quality-tieri ng methodology. Because this is the same policy as for the CY 2016 payment adjustment period, we are also ma king a conforming revision to §414.1270(b)(4).

We are finalizing a policy that, for groups that are assessed under th e “50 percent option” where some EPs in the group report data using a qualified clinical data registry and we are unable to obtain the data, but ot her EPs in the group report data using the other PQRS reporting mechanisms for individuals, then we will calculate the group’s score based on the reported performance data that we obt ain through those other PQRS reporting mechanisms. We are finalizing a policy that, beginning with the CY 2014 performance period, measures reported through a PQRS qualified clinical data registry th at are new to PQRS will not be included in the quality composite for the VM until such time as we have historical data to calculate benchmarks

for them. Once we have historical data from me asures submitted via QCDRs, the benchmark for quality of care measures will be the national mean for the measure’s performance rate during theCMS-1612-FC 1011

year prior to the performan ce period (§414.1250). We are finaliz ing our proposed clarification

that we calculate benchmarks for the out come measures described in §414.1230 using the national mean for a measure's performance rate during the year prior to the performance period in accordance with our regulation at §414.1250( b). Although we did not include proposed regulation text for this proposed clarification of our policy, we are finalizing revisions to regulation text at 414.1250(b) to reflect this final policy. Quality Measures for the Shared Savings Program: Starting with the CY 2017 payment adjustment period, as described in section III.M. of this final rule with comment period , we proposed to apply the value modifier to groups and solo practitioners participating in ACOs under the Shared Savings Program. To do so, we proposed quality measures and benchmarks for use with these groups and solo practitioners and solicited public comment on these proposals. We describe these proposals more fully below. With regard to quality measures, we noted th at there is substantial overlap between those

used to evaluate the ACOs under the Shared Savings Program and those used in the PQRS program and for the value modifier payment adjustment. For the CY 2017 payment adjustment period and subsequent payment adjustment periods, to determine a quality composite for the VM for groups and solo practitioners who participat e in an ACO under the Shared Savings Program, we proposed to use the quality measures that are identical for the two programs. Specifically, for the CY 2017 payment adjustment period, we prop osed to use the PQRS GPRO Web Interface

measures and the outcome measure described at §414.1230(c) to determine a quality composite for groups and solo practitioners who participat e in an ACO under the Shared Savings Program.

Because the ACO GPRO Web Inte rface measures and PQRS GP RO Web Interface measures will be the same in CY 2015, we proposed to us e the GPRO Web Interface measures reported by ACOs in determining the quality composite for groups and solo practiti oners participating inCMS-1612-FC 1012

ACOs under the Shared Savings Program in CY 2017 (79 FR 40507). Ut ilizing these GPRO Web Interface measures in this regard further encourages successful quality reporting for Shared Savings Program ACOs. Additionally, we stat ed our belief that the all-cause hospital

readmissions measure as calculated for ACOs under the Shared Savings Program is equivalent to the all-cause hospital readmissions measure we have adopted for the VM at §414.1230(c), and therefore, proposed use of that measure as calc ulated for ACOs in the Shared Savings Program for inclusion in the VM for the CY 2017 paym ent adjustment period (79 FR 40507). We note

that the outcome measures described at §414.1230(a) and §414.1230(b) are not currently calculated for ACOs in the Shared Savings Program . These measures are: (1) a composite of rates of potentially preventable hospital ad missions for heart failure, chronic obstructive pulmonary disease, and diabetes; and (2) a com posite rate of potential ly preventable hospital admissions for dehydration, urinary tract infections , and bacterial pneumonia. Because we have no experience with these measures in the Shared Savings Program, at this time, we did not propose to include these measures for groups and solo practitioners who participate in ACOs under that program. We proposed to modi fy the regulations at §412.1210 accordingly. The following is summary of the comme nts we received on these proposals. Comment: The majority of commenters oppos ed the proposals for two reasons. First, these commenters expressed their belief that th e ACO would be required to report measures twice or report additional measures. Second, th ese commenters suggested that aligning the measures used in the Shared Savings Program a nd those in the VM program could lead to ACOs scoring well in one program while performing poorly in the other. Commenters believe that the VM and Shared Savings Program use differe nt performance benchmarks and different approaches for determining good versus bad performance.CMS-1612-FC 1013

A few medical societies suppor ted the proposals, recognizing CMS’s intent to align the measures and quality improvement goals of th e Shared Savings Program and VM program. Several commenters suggested allowing groups that are new to GPRO Web Interface reporting to have at least one year to report measures be fore they are measured for performance. A few commenters recommended aligning the Shared Savings and the VM programs by removing the

three claims-based outcome measures from the VM. Response: We disagree with the comment ers’ suggestion that utilizing GPRO Web Interface measures to calculate Shared Savings Program ACO’s quality composites would cause them additional reporting burden, because the ACO GPRO Web-Interface measures and PQRS

GPRO Web-Interface measures are th e same. We believe, therefore, that utilizing the GPRO web interface measures for Shared Savings Progr am ACO quality composite calculation under the VM will further encourage successful quality reporting for ACOs in the Shared Savings Program and will not add burdensome reporting requirements. ACOs in the Shared Savings Program would not have to report measures twice for pur poses of the VM. Moreover, the use of the GPRO Web Interface measures fosters alignm ent among the various CMS quality reporting programs. With regard to commenters’ s uggestion that Shared Savings Program ACO participants might fare well on measures report ed under the Shared Savings Program and poorly under the VM program, we do not believe this situ ation is likely to occur, because within the Shared Savings Program, ACOs will be measur ed against national benchmarks that are calculated using Medicare fee-for service data. The VM program also develops benchmarks using all available Medicare fee-for-serv ice data. Although the benchmarking methodology differs in that the VM uses a national weight ed mean and the Shared Savings Program use a decile distribution for measuring performance, we believe using the same data source enables a fair comparison for all groups and solo prac titioners subject to the value modifier.CMS-1612-FC 1014

Further, we believe it is appr opriate to use the Shared Sa vings Program ACOs’ all-cause readmission measure for calculating the VM for th e CY 2017 payment adjustment period. As we stated in the proposed rule, we believe that the Shared Savings Program ACO all-cause readmission measure is equivalent to the all-ca use hospital readmission measure adopted for the VM. The use of this measure will not impose a ny additional reporting burden on Shared Savings Program ACOs (79 FR 40508). After considering the public comments, we are finalizing a policy to use the ACO Group Practice Reporting Option (GRPO) Web Interfa ce measures and the Shared Savings Program

ACO all-cause readmission measure to calculate a quality composite score for groups and solo practitioners who particip ate in an ACO under the Shared Savings Program. To determine the standardized scores for these quality measures for use with those participating in ACOs under the Shared Savings Program, we proposed to apply the benchmark policy for quality measures for the VM as described under §414.1250. Under this policy, the

VM benchmarks are the national mean for a meas ure’s performance rate based on data from one year prior to the performance pe riod. We believe these are the appropriate benchmarks to use when determining the value modifier payment adju stment because they are the same benchmarks used to determine the value modifier payment ad justment for other groups and solo practitioners and they are similar to the benchmarks used und er the Shared Savings Program. As stated above, within the Shared Savings Program, ACOs will be measured against national benchmarks that are calculated using Medicare fee-for service data and the VM program also develops benchmarks using all available Medicare fee-for- service data., We believe that use of the VM benchmarks creates a reasonable comparison am ong groups and solo practitioners and it is appropriate to evaluate those th at participate in Shared Savings Program ACOs on the same basis as those that do not participate in the Shared Savings Program for the purpose of the valueCMS-1612-FC 1015

modifier. We believe that the VM benchmarks are appropriate because they include all PQRS data available (77 FR 69322), including quality data used for the Shared Savings Program. . We stated that , while the Shared Savings Pr ogram develops benchmar ks using all available Medicare fee-for-service data, we do not believe it is appropriate to use benchmarks from the Shared Savings Program to determ ine standardized scores for the quality composite of the value modifier payment adjustment. We do not think this enables a fair comparison among groups and solo practitioners subject to th e value modifier because the Shared Savings Program benchmarks use gradients by decile (including the median) of national performance based on data two years prior to the performance period (78 FR 74759 through 74760). The following is summary of the comme nts we received on these proposals. Comment: A number of commenters opposed th e proposal for the following reasons: the belief that a difference in performance benchm arks for the VM and Shared Savings Program could cause ACOs to score well in one program a nd perform poorly in the other; and the belief that the application of the VM benchmarking po licy to the quality measures used by ACOs under the Shared Savings Program could introduce potential bias into the broader VM program. One commenter supported our proposal, noting th at alignment of quality measures for the VM and Shared Savings Program woul d strengthen the benchmarks by establishing a larger pool of providers with comparable measures. Response: We appreciated the comments recei ved. As stated above, with regard to the suggestion that Shared Savings Program ACO par ticipants might fare well on measures reported under the Shared Savings Program and poorly un der the VM program, we do not believe this situation is likely to occur, because the GP RO Web Interface measures used for the Shared Savings Program ACOs and the VM are the sa me and benchmarks used for performance measurement on use the same data source (fee-f or-service Medicare data ). We also do notCMS-1612-FC 1016

believe that introduction of SSP ACO data into the benchmarks would create a bias. We utilize national data for benchmarking, and we agree with the commenter who stated that this will strengthen the benchmarks by expanding the pool of participants. After consideration of the public comments received, we are finalizing the proposal to apply the benchmark policy for quality measures for the VM as described unde r §414.1250 to determine th e standardized score for quality measures for groups and solo practiti oners participating in ACOs under the Shared Savings Program. All-Cause Hospital Readmissions Measure: We finalized the inclusion of the all-cause hospital readmissions measure described at §414.1230(c) in the CY 2013 PFS final rule with comment (77 FR 69285). We subsequently investigated the reliability of this measure. We also have an existing policy at §414.1265, that a claims-b ased cost or quality measure must have a minimum of 20 cases, to be included in a compos ite score calculation. Furthermore, according to §414.1265(a), if a group has fewer than 20 cases for a measure in a performance period, that

measure is excluded from its domain and the rema ining measures in the domain are given equal weight. Based on 2012 data, we found that the averag e reliability for the all-cause hospital readmissions measure was below 0.4 when we examined groups with fewer than 200 cases but exceeded 0.4 for groups with 200 or more cases. Although we do not believe there is a universal consensus concerning a minimum re liability threshold, re liability scores in the 0.4 to 0.7 range are often considered moderate, and scores greater than 0.7 are considered high. In general, we found that the groups with at least 10 eligible professionals were mo re likely to have 200 or more cases as compared to groups with fewer eligible professionals. Th irty percent of groups with 10 or more eligible professionals had 200 or more cas es, as compared to 3 percent of groups with 1-CMS-1612-FC 1017

9 eligible professionals. We found that the av erage reliability exceeded 0.4 for groups of all sizes (1 or more eligible profession als), with 200 or more cases. . After examining the reliability of the all- cause hospital readmissions measure data for 2012 across all group sizes and cons idering its impacts on the cost composite of the VM as discussed below, we proposed to change the re liability policy (minimum number of cases) with respect to this measure. Specifically, begi nning with the CY 2017 payment adjustment period, we proposed to change the reliab ility policy (minimum number of cases) with respect to the allcause hospital readmissions measure as descri bed in §414.1230(c) from a minimum of 20 cases

to a minimum of 200 cases for this measure to be included in the quality composite for the VM. For this measure only, we proposed to exclude the measure from the quality domain for a group or solo practitioner if the group or solo practit ioner has fewer than 200 cases for the measure during the relevant performance period. In impl ementing this proposal, we noted that we would only apply it to the all-cause hos pital readmissions measure as it is calculated for groups or solo practitioners who are not part of a Shared Savi ngs Program ACO. In instances where we are including Shared Savings Program data for groups or solo practitioners w ho are part of a Shared Savings Program ACO, we would include their a ll-cause hospital readmissions measure as it is calculated for the Shared Savings Program. This approach to implementing this proposal is appropriate because the Shared Savings Program has taken into consideration the size of its groups in finalizing inclusion of this measure, and we value cons istency with the Shared Savings Program’s reporting requirements for its participan ts, to the extent it is practicable. We would continue to include the measure in the VM quali ty domain for groups or solo practitioners who have 200 or more cases. We proposed to modify §414.1265 to reflect this proposal. We welcomed comments on this proposal.CMS-1612-FC 1018

We noted that, if we were to revise the minimum case size for the all-cause hospital readmissions measure for the quality composite of the VM, poor performance on controlling

readmissions would continue to have an eff ect on the VM for groups with between 20 and 199 cases through the cost composite of the VM. The Medicare Sp ending per Beneficiary (MSPB) measure, as finalized in the CY 2014 PFS fina l rule (78 FR 74775-74780), is a measure of all Medicare Part A and Part B payments during an episode spanning from 3 days prior to an index hospital admission through 30 days pos t-discharge with certain exclusions. Since all Part A and Part B spending is included in the 30 day post- discharge window, Medicare Part A payments for a readmission that are included in an MSPB ep isode will increase the MSPB amount relative to an MSPB episode without a readmission in the 30 -day post-discharge window. Additionally, the cost of readmissions is incorporat ed as part of the 5 total per capita cost m easures that comprise the remainder of the cost composite of the VM. The 5 total per capita cost measures are annual

measures that include the costs of all Part A and Part B spending duri ng the year, including the costs of readmissions. Therefore, readmission cost s will have the effect of increasing total per capita cost spending for the groups attributed these patients’ costs. As a result, poor performance on controlling readmissions already will have an a dverse effect on an attributed group’s cost composite of the VM, even if poor performance on the all-cause hospital readmissions measure would no longer be reflected in certain groups’ or solo practitioners’ quality composite of the VM due to having fewer than 200 all-cause hosp ital readmission cases. Even for those groups for which the all-cause hospital readmissions measure would be excluded from the quality composite calculations, groups would continue to have incentive to control readmissions, since doing so would reduce readmission costs, th ereby improving performance on the paymentstandardized, risk-adjusted cost measures us ed for the cost composite of the VM. The following is summary of the comme nts we received on this proposal.CMS-1612-FC 1019

Comment: We received few comments on th is proposal. Some commenters supported

the inclusion of the all-cause readmission m easure. One commenter supported the proposed change in the reliability policy for the hospital all-cause readmission measure, stating that this will provide valid and reliable estimates fo r hospital admissions to each group. Several commenters supported the need for reliable m easures; however, one commenter expressed

concern that even with an increased case mini mum, the all-cause readmission measure was still not appropriate for physician accountability becau se the readmission costs are already included in the total per capita co sts, the measure was not specified for group level measurement, and the measure was not supported by the Measures Applic ation Partnership (MAP ). This commenter

stated that the all-cause readmission measure doe s not add value to the VM, further suggesting that if CMS chooses to keep the measure, then it should be adjust ed for clinical and

socioeconomic factors. Another commenter reco mmended CMS undertake an analysis to ensure this change would not result in disproportionate penalties for certa in groups (such as surgeons) prior to finalizing this proposal.

One commenter stated that this measure is not appropriate for physic ian practices because

2012 data indicates that the measure could not m eet a 0.4 percent reliability threshold at a 20- case minimum. This commenter also questioned th e justification for including a measure that will be applicable only to 30 percent of groups w ith 10 or more practitioners and three percent of smaller groups, even when the proposed minimum 200 case threshold is utilized. Response: We disagree with the commenters’ assessment of the reliability of the allcause hospital readmission measure, which quant ifies the unplanned readmissions for any cause within 30 days from the date of discharge of an index admission. Our analysis of this measure based on 2012 data found that the average reliab ility exceeded 0.4 for groups with 200 or more cases included all group sizes (1 or more e ligible professionals). We are committed toCMS-1612-FC 1020

monitoring this measure, as well as others to ensure that the minimum patient panel size is sufficient to meet the reliability standard for the VM program. With regard to concern that

readmission costs are included in other spending measures, we disa gree that this fact makes the all-cause hospital readmissions measure inapprop riate for inclusion in the VM. The all-cause hospital readmissions measure is a measure of read mission rates, not of costs and we believe that readmission reduction is an important goal that we can emphasize through the VM. We note that the measure’s direction was supported by the MAP and also that the has been specified for groups. The group specifications may be found at: http://cms.gov/Medi care/Medicare-Fee-forService-Payment/sharedsavingspr ogram/Downloads/ACO-8.pdf With regard to commenters’ concerns rela ted to the issue of socioeconomic status adjustment, we continue to monitor activities at the National Quality Forum (NQF), such as the July 23, 2014 decision by the NQF Board in which the Board approved a tria l period to test the impact of sociodemographic fact or risk adjustment of perfor mance measures (available at http://www.qualityforum.org/Press_Release/ 2014/NQF_Board_Approves _Trial_Risk_Adjustme nt.aspx). While we continue to evaluate the appropriateness of applying different standards for the outcomes of patients of low socioeconomic st atus and the potential for an socioeconomic status adjustment to mask potential disparitie s or minimize incentives to improve the outcomes of economically disadvantaged populations, we would take any future decision by the NQF on this issue into consideration for any potential futu re refinements to this or any measure included

in the VM

. After consideration of the comments, we are finalizing the policy, be ginning with the CY 2017 payment adjustment period, to increase th e case minimum from 20 cases to 200 cases for the all-cause hospital readmissions measure as de scribed in §414.1230(c) to be included in the quality composite for the VM as proposed. Therefore, we are fi nalizing the proposal to excludeCMS-1612-FC 1021

the measure from the quality domain for a group or solo practitioner if the group or solo practitioner has fewer than 200 cas es for the measure during the relevant performance period and all remaining measures in the domain will be given equal weight. We are codifying this change with a revision to the regulation at §414.1265. i. Expansion of the Informal Inquiry Proce ss to Allow Corrections for the Value-Based Payment Modifier Section 1848(p)(10) of the Act provides that th ere 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 VM;

● The evaluation of the quality of care composite, including th e establishment of appropriate measures of the quality of care;

● The evaluation of the cost composite, in cluding the establishm ent of appropriate measures of costs;

● The dates of implementation of the VM;

● The specification of the initial performan ce period and any other performance period;

● The application of the VM; and

● The determination of costs. These statutory requirements regarding limita tions of review are reflected in §414.1280. Despite the preclusion of administ rative and judicial review, we previously indicated in the CY 2013 PFS final rule with comment period (77 FR 69326) that we believed an informal review mechanism is appropriate for groups of physicians to review and to identify any possible errors prior to application of the VM, and we establ ished an informal inquiry process at §414.1285. We stated that we intend to disseminate repor ts containing CY 2013 data in the fall of 2014 toCMS-1612-FC 1022

groups of physicians subject to the VM in 2015 and that we will make a help desk available to address questions relate d to the reports. We stated it would be appropr iate to align with PQRS to consider requests for informal review of whether a group or solo practitioner successfully reported under the PQRS program and requests for reconsideration of PQRS data as described in section III. K, as well as to expand our current informal inquiry process to accept re quests from groups and solo practitioners to

review and correct certain othe r errors related to the VM, su ch as errors made by CMS in assessing the eligibilit y of a group or solo practitioner for the value modifier based on participation in a Shared Savings Program ACO, the Pioneer ACO Model, the CPC Initiative, or

other similar Innovation Center models or CMS initiatives; computing standardized scores; computing domain scores; computing composite scor es; or computing outcome or cost measures. We are working to develop and operationalize th e necessary infrastructure to support such a corrections process, but at this time, we do not believe we would be able to implement the process until 2016 at the earliest. Therefore, for the CY 2015 payment adjustment period, to align with PQRS, we proposed to expand the informal inquiry process at §414.1285 to establish an initial corrections process

that would allow for some limited corrections to be made (79 FR 40509). Specifically, under this initial corrections proce ss, for the CY 2015 payment adjustment period, we proposed to establish a deadline of January 31, 2015 for a group to request co rrection of a perceived error made by CMS in the determination of its CY 2015 VM payment adjustment. Alternatively, we

solicited comment on a dead line of no later than th e end of February 2015 to align with the PQRS informal review process. We would then make a determination regarding the request. At this time, we do not anticipate it would be operationa lly feasible for us to fully evaluate errors with regard to quality measure data and accept da ta as described above under section III.K. forCMS-1612-FC 1023

the CY 2015 payment adjustment period, and thus we proposed to classify a TIN as “average quality” in the event we determine that we have made an error in th e calculation of quality composite. We proposed to recompute a TIN’s cost composite in the event we determine that we have made an error in its calculation. We propos ed to adjust a TIN’s qua lity-tier if we make corrections to a TIN’s quality and/or cost com posites as a result of this initial corrections process. We noted that there w ould be no administrative or judici al review of the determinations resulting from this expanded informal inquiry process under section 1848 (p)(10) of the Act. Starting with the CY 2016 payment adjustment period (which has a performance period of CY 2014), we proposed to continue the expa nded informal inquiry process at §414.1285 as described above. However, in an ticipation of having the necessar y operational infrastructure to support the reconsideration of quality measure da ta, we proposed to establish a 30-day period

that would start after the releas e of the QRURs for th e applicable performance period for a group or solo practitioner to request correction of a pe rceived error made by CMS in the determination of the group or solo practitioner’s VM for th at payment adjustment period. These QRURs contain performance information on the quality and cost measures used to calculate the quality and cost composites of the VM and will show how all TINs would fare under the policies established for the VM for the CY 2015 payment ad justment period. Similar to our proposal for

the initial corrections process in CY 2015, we would then ma ke a determination regarding the requests received. Since we anticip ate it would be operationally feas ible for us to fully evaluate errors with regard to quality measure data at that point, and accept data, consistent with PQRS policies, as described above under section III.K. for the CY 2016 payment adjustment period, we proposed to recompute a TIN’s quality composite and/or cost composite in the event we

determine that we have made an error in th e calculation. We noted that if the operational

infrastructure is not available to allow this recomputation, we pr oposed to continue the approachCMS-1612-FC 1024

of the initial corrections process to classify a TIN as “average quality” in the event we determine

that we have made an error in the calculation of the quality composite. We proposed to adjust a TIN’s quality-tier if we make a co rrection to a TIN’s quality and/or cost composites as a result of this corrections process. We welcomed comment on these proposals. The following is summary of the comments we received on both the initial corrections process in the CY 2015 payment adjustment peri od and the corrections process we proposed beginning with the CY 2016 payment adjustment period. Comment: Commenters supported implementing an expanded informal inquiry process to allow for corrections to the VM. However, almost all commenters requested later deadlines for submission of VM corrections. Specifically:

● For 2015, most commenters supported estab lishing a deadline of no later than the end of February 2015, rather than January 31, to ali gn with the PQRS informal review process.

● For subsequent years, most commenters requested a longer period of 60 to 90 days (rather than 30 days) that woul d start after the release of the QRURs for the applicable performance period for a group or individual to re quest a correction of a perceived error related

to the VM calculation. In addition, some commenters objected to th e proposal for 2015 to classify a TIN as ‘‘average quality’’ in the event we determined that we have made an error in the calculation of the quality composite. These commenters believ e it would be inappropriate to deem a group “average quality” simply because CMS does not have the capacity to correct its own errors, especially if an “average quali ty” rating could potentia lly lead to penalties or lost incentive payments. Some commenters sugge sted that we consider reque sts for providers to resubmit their quality data. Other comme nters asked that we provide additional clar ification regardingCMS-1612-FC 1025

what situations will be considered in the informal review process. Response: We are persuaded by commenter s who request that we establish later deadlines for the VM informal review process so th at such deadlines are c onsistent with those of the PQRS informal review process. We agr ee with these comments since data reported under PQRS is an important component of the VM and that corrections to PQ RS measure rates could affect the calculation of the VM payment ad justment amount. Therefore, for the CY 2015 payment adjustment period, the deadline for subm ission of a request for VM informal review will be the end of February, 2015. Likewise, for subsequent payment adjustment years, we are persuaded by commenters that requested a longe r period beyond 30 days, which would start after the release of the QRURs for th e applicable performance peri od, for a group or individual to request a correction of a perceive d error related to the VM calcul ation. However, we believe that 60 days, not 90 days, would be a sufficient amou nt of time for providers to access their QRUR reports, review the information, which includes the VM payment adjustment amount that will apply for the subsequent payment adjustment yearand make a decision whether or not to submit a VM correction request. Establishing a 60-day d eadline enables us to make corrections prior to, or relatively soon after, the start of the appli cable payment adjustment year. This helps reduce

the number of claims that would need to subs equently be reprocessed during the applicable payment adjustment year. Finally, as we discussed in the proposal and above, it is not operationally feasible to fully evaluate errors with regard to quality measur e data and accept data as described above under section III.K. for the CY 2015 payment adjustment period. Therefore, to minimize the impact on providers, we will classify a TIN as ‘‘average quality’’ in the event that we determine that we

have made an error in the cal culation of the quality composite. However, we understand the point made by a few commenters about this policy. It is possible th at an “average quality” ratingCMS-1612-FC 1026

for the CY 2015 payment adjustment period could potentially result in a higher or lower VM payment adjustment amount for an individual TIN than if the quality composite were recalculated. Therefore, we are working to deve lop the operational infrastructure to allow us to re-compute a TIN’s quality composite and accept data, consistent with PQRS quality data resubmission policies, as described above under section III.K. for the CY 2016 payment adjustment period in the event we determine that we have made an erro r in the calculation.

After consideration of th e public comments received:

● For the CY 2015 payment adjustment peri od, we are: (1) finaliz ing a February 28, 2015, deadline for a group to request correcti on of a perceived error made by CMS in the determination of its VM, and (2) finalizing a polic y to classify a TIN as ‘‘average quality’’ in

the event we determined that we have made an error in the calculation of the quality composite.

● Beginning with the CY 2016 payment adjustment period, (1) we are finalizing a deadline of 60 days that woul d start after the re lease of the QRURs for the applicable performance period for a group or solo practitione r to request a correcti on of a perceived error related to the VM calculation, and (2) we will ta ke steps to establish a process for accepting requests from providers to corr ect certain errors made by CMS or a third-party vendor (for example, registry). We intend to design this process as a means to re-compute a TIN’s quality composite and/or cost composite in the event we determine that we initially made an erroneous

calculation. We note that if the operational infrastructure is no t available to allow this recomputation, we will continue the approach for the CY 2015 payment adjustment period to classify a TIN as ‘‘average quality ’’ in the event we determine that we have made an error in the calculation of the quality composite. For both the CY 2015 payment adjustment period and future adjustment periods, we will adjust a TIN’s quality-tier if we make a correction to a TIN’s quality and/or cost composites as aCMS-1612-FC 1027

result of this corrections process. We will pr ovide additional operational details as necessary in sub-regulatory guidance.

We further note that there is no administrative or judicial review of the determinations resulting from this expanded informal inquiry process under section 1848 (p)(10) of the Act. j. Potential Methods to Address NQF Concerns Regarding the Total Per Capita Cost Measures

In the CY 2013 PFS final rule with comment period (77 FR 69322), we established a policy to create a cost composite for each group subject to the VM that includes five paymentstandardized and risk-adjusted a nnual per capita cost measures. To calculate each group’s per capita cost measures, we first at tribute beneficiaries to the gr oup. We attribute beneficiaries using a two-step attribution methodology that is based on the assignment methodology used for the Shared Savings Program and the PQRS GPRO and that focuses on the delivery of primary care services (77 FR 69320) by both primar y care physicians and specialists.

In the CY 2014 PFS final rule with comme nt period (78 FR 74780), we finalized inclusion of the Medicare Spending Per Benefici ary (MSPB) measure as proposed in the cost composite beginning with the CY 2016 VM, with a CY 2014 performance period. As we proposed, we are using the MSPB amount as th e measure’s performance rate rather than converting it to a ratio as is done under the Hosp ital Inpatient Quality Reporting (IQR) and VBP Programs. We finalized that the MSPB measure is added to the total per capita costs for all attributed beneficiaries domain and equally weight ed with the total per ca pita cost measure in that domain. Additionally, we finalized that an M SPB episode is attributed to a single group of physicians that provides the plur ality of Part B services (as m easured by standardized allowed charges) during the index admission, for the purpo se of calculating that group’s MSPB measure rate. Finally, we finalized a minimum of 20 MS PB episodes for inclusio n of the MSPB measure in a physician group’s cost composite.CMS-1612-FC 1028

Additionally, in the CY 2014 PFS final rule with comment period (78 FR 74780), we finalized our proposal to use the specialty adjustment method to cr eate the standard ized score for each group’s cost measures beginning with the CY 2016 VM. That is, we refined our current peer group methodology to account for specialty mix using the specialty adjustment method. We also finalized our proposal to include this policy in our cost composite methodology. Additionally, we finalized our proposal to iden tify the specialty for each EP based on the specialty that is listed on the largest share of the EP’s Part B claims. As discussed in the CY 2014 PFS final rule with comment period (78 FR 74781), we submitted the total per capita cost measure fo r National Quality Forum (NQF) endorsement in January 2013. In the final voting in Se ptember 2013, the NQF Cost and Resource Use Committee narrowly voted against the measure by a count of 12 in support and 13 in opposition. We proposed to address two of the major concerns that Committee raised in its review of the measure. First, we proposed modifications to our two-step attribu tion methodology. Second, we proposed to reverse the current exclusion of certain Medicare bene ficiaries during the performance period. We stated that these pr oposals would apply begi nning with the CY 2017 payment adjustment period for the VM and would a pply to all five of the total per capita cost measures under §414.1235(a)(1) thr ough (5) (79 FR 40510). The modifications to the two-step attribution methodology also would apply to the methodology used for attributing beneficiaries for the computation of claims based quality measures under §414.1230, except for participants in the Shared Savings Program as described later. The attribution methodology for the five total per capita cost measures and claims based quality measures in the VM, as finalized in the CY 2013 PFS final rule with comment period (77 FR 66318 through 66320), includes two steps. Before applying the two steps, however, we first identify all beneficiaries who have had at least one primary car e service rendered by aCMS-1612-FC 1029

physician in the group. Primary care services in clude evaluation and management visits in office, other outpatient, skilled nursing facility, and home settings . After this “pre-step”, we assign, under Step 1, beneficiaries to the group practice who had a plurality of primary care services (as measured by allowed charges) rendered by primary care physicians in the group, which include Family Practice, Internal Medicine, General Practice, and Geri atric Medicine. If a beneficiary is non-assigned under Step 1, we proceed to Step 2, which is to assign beneficiaries to the group practice whose affiliated non-primar y care physicians, nurse practitioners (NPs), physician assistants (PAs), and clinical nurse sp ecialists (CNSs) together provided the plurality of primary care services (as meas ured by allowed charges), as l ong as at least one primary care service was provided by a non-prim ary care physician in the group. To address NQF concerns regarding the attr ibution methodology of th e total per capita cost measure, we proposed two modifications to the two-step attribut ion methodology as applied to the five total per capita cost measures, as well as the claims based quality measures in the VM. NQF Committee members discussed how primary care services often are provided by NPs, PAs, or CNSs, but Step 1 of the attribution methodol ogy assigns beneficiarie s to the group who had a plurality of primary care services rendered by pr imary care physicians in the group. After further consideration, we agreed that it is appropriate to include NPs, PAs, and CNSs in Step 1 of the attribution method insofar as they provide primar y care services. Conse quently, we proposed to move these NPs, PAs, and CNSs from Step 2 of the attribution method to Step 1. This change would affect all five of the total per capit a cost measures under §414.12 35(a)(1) through (5) and the claims-based quality measures under §414.1230. Additionally, we proposed to remove the “pre -step” described above for the purposes of the value modifier. The “pre-step” was incl uded in the Shared Savings Program assignment methodology to comply with the statutory re quirement (77 FR 67851) that beneficiaryCMS-1612-FC 1030

assignment be based upon the utilization of pr imary care services furnished by a physician. However, no such limitation exists for the VM. Consequently, we proposed to remove the “prestep” that identifies a pool of assignable beneficiaries that have had at least one primary care service furnished by a physician in the group. Removing the “pre-ste p” would result in streamlining the attribution process and attributin g beneficiaries based on a plurality of primary care services according to Step 1 and Step 2. In addition, we believe that this proposal would help ensure that beneficiaries can be a ssigned to group practices made up of nonphysician eligible professionals because it would eliminate the crite rion that a beneficiary have at least one primary care service furnished by a physician in the group practice. This change (removing the “pre-step”) would affect all five of the total per capita cost measures under §414.1235(a)(1) through (5) and the claims-based quality measures under §414.1230. The two-step attribution rule would remain intact after these two modifications, and the method would continue to be generally consistent with the method of assignment of beneficiaries under the Shared Savings Program, as specified under §414.1240. As discussed previously, the “pre-step” would be removed. We would assign, under Step 1, beneficiaries to the group who had a plurality of primary care services (as m easured by allowed charges) rendered by primary care physicians, NPs, PAs, or CNSs in the group. If a beneficiary is non-assigned under Step 1, we still would proceed to Step 2, which would assign beneficiaries to the group practice whose affiliated non-primary care physicians provided the plurality of prim ary care services (as measured by allowed charges). We proposed these modifications only for groups and solo practitioners who are not particip ating in the Shared Savings Progr am. We noted that for groups and solo practitioners who participate in the Sh ared Savings Program, we would not remove the pre-step or change the attri bution methodology for quality measures and cost measures, but would continue to rely on the methodology used by the Shared Savings Program to attributeCMS-1612-FC 1031

beneficiaries to ACOs in the Shared Savings Program. Because we are not applying these assignment changes to Shared Savings Program ACO participants, there is no need to recalculate Shared Savings Program assignment. One of the reasons we originally proposed th is two-step attribution process for the total per capita cost measures and claims based qual ity measures was that it was aligned with the attribution methodologies used by the Shared Sa vings Program and also the PQRS GPRO web interface (77 FR 69318 through 69320). We recognize th at these programs may seek to establish changes to their methodologies, and noted that for the purposes of the VM, we intended to retain the two-step beneficiary attr ibution methodology that was desc ribed in the CY 2013 PFS final rule with comment period (77 FR 69318 through 69320), subject to the changes proposed above. However, to address the concerns raised by NQF , we believe the proposed modification to the two-step beneficiary attributi on method would more appropriately reflect the multiple ways in which primary care services are provided, wh ich are not limited to physician groups. We welcomed comments on our proposed modificati on to the two-step attribution methodology as applied to the five total per capita cost measures under §414.1235(a )(1) through (a)(5) and to the claims-based quality measures under §414.1230 of the VM. The following is summary of the comments we received on our proposed modification to the two-step attribution methodol ogy as applied to the five tota l per capita cost measures under §414.1235(a)(1) through (5) and to the claims-bas ed quality measures under §414.1230 for the

VM. Comment: Many commenters opposed our proposa l to modify the two-step attribution methodology. The commenters stated that it would not be appropriate to include NPs, PAs and CNSs in the first step of the attribution me thodology because these nonphysician practitioners are not necessarily practicing in a primary care setting. The comm enters expressed concern that,CMS-1612-FC 1032

unlike for physicians, there is no specialty distinction on claims billed by NPs, PAs, or CNSs. Therefore, CMS would not be able to distinguis h between those practitio ners who are practicing in primary care settings and those who are in non-primary care settings . Commenters believe that moving NPs, PAs, and CNSs to the first step could result in beneficiaries being attributed to a specialty practice instead of a primary care practice. A few co mmenters stated that this would unfairly affect the cost measure calculations for specialist groups w ith large numbers of nonphysician practitioners. We did not receive any comments specifically opposing the removal of the “pre-step” from the methodology. Severa l commenters supported ou r proposal to modify the attribution methodology. The comme nters stated that it is impor tant to recognize the role of nonphysician practitioners in prov iding primary care to benefici aries and that these changes create a methodology that more accurately refl ects team-based approaches to care. Response: We appreciate the concerns rais ed by commenters about the potential impact that the lack of specialty desi gnation for NPs, PAs, and CNSs c ould have on the cost and claims based quality measures. However, we do not believe th at this is likely to occu r. In an analysis of the impact of including NPs and PAs in step 1 of the attribution met hodology using 2011 data for groups of twenty-five or more eligible prof essionals, we found that over 97 percent of

beneficiaries were attributed to the same group that they had been attributed to under the current methodology. Although this analysis does not exactly replicate the changes we proposed, we

believe it is a reasonable indication that the changes will not have the significant impact predicted by commenters. We are conducting additio nal analysis and will monitor the effect of these changes to ensure they ar e not having a disproportionately negative effect on a subset of provider types. We appreciate the support of and agree with commenters who believe it is important to recognize the role th at many NPs, PAs, and CNSs pl ay as primary care providers. The analysis referenced earlier al so found that the inclusion of NPs and PAs in step 1 resulted inCMS-1612-FC 1033

an increase of 2.55 percent to the number of beneficiaries attribut ed to a group and the number of groups to which at least 20 bene ficiaries were attributed incr eased by 3.4 percent. For these reasons, we agree with the NQF recommendation to include these nonphysician practitioners in the attribution methodology. Furthe r, this attribution change w ill become even more important as we expand the application of the VM to sma ller groups and solo practitioners, to increase the number of patients whom they can be assigned, to receive a cost composite that is other than “average” under the VM. We are finalizing our policy as proposed. Be ginning in the CY 2017 payment adjustment period, we will move NPs, PAs, and CNSs from step 2 of the attribution method to step 1. Additionally we are removing the pre-step under which we first identify all beneficiaries who have had at least one primary care service re ndered by a physician in the group. These changes apply to all five total per cap ita cost measures under §414.1235(a )(1) through (5) and the claimsbased quality measures under §414.1230. Second, NQF committee members raised conc erns about the exclusion of certain beneficiaries in the methodology used for the tota l per capita cost measure. Committee members expressed concern that end-of-lif e costs were not being captured by the measure. We considered this argument and agreed that it is important to include certain benefici aries with these costs during the performance period. As a result, we proposed to include cert ain part-year Medicare FFS beneficiaries. This change would affect all five of the total per capita cost measures under §414.1235(a)(1) through (a)(5). The ch ange would provide a more complete assessment of end of life costs associated with the patients a phys ician group sees during th e year (79 FR 40510). We proposed to continue excluding other part -year beneficiaries (thos e who spend part of the performance period in a Medicare Advantage (Par t C) plan and those enrolled in Part A only or Part B only for part of the performance peri od and both Part A and Part B for the remainder ofCMS-1612-FC 1034

the performance period) (79 FR 40511). Since 2012 we have applied the same attribution rule as that used for the Medicare Shared Savings Progr am and the PQRS GPRO Web Interface (77 FR 69318-20). In this regard, excl uding part-year Medicare Adva ntage enrollees would remain consistent with the Shared Savings Program a nd PQRS GPRO web interf ace reporting policy. If we were to include these part-y ear Medicare Advantage enrollees, we would need to determine a method to impute their costs for the portion of the performance period in which they were

enrolled in FFS Medicare Parts A and B so that we could compare bene ficiaries’ annual per capita costs appropriately. Simila rly, Medicare Part A only or Medicare Part B only enrollees

who were enrolled in both Part A and Part B fo r only part of the performance period would also require a method to impute their costs if they we re no longer excluded. Furthermore, these Part A only or Part B only beneficiaries are exclude d from the Shared Savings Program and PQRS GPRO methodology. We proposed including Medicare FFS benefici aries who are newly enrolled to Medicare during the performance period and en rolled in both Part A and Part B while in Medicare FFS. Additionally, we noted that while the inclusion of new enrollees is inconsistent with GPRO’s methodology, it would be consistent with the Shared Savings Program’s methodology (79 FR 40511). We welcomed comments on the inclusion of these part-year beneficiaries. We also welcomed comments on whether other part-year Me dicare FFS beneficiarie s (that is, those who are part-year Medicare Advantage enrollees or part-year Medicare Part A only or Part B only enrollees) should be included in the five to tal per capita cost m easures under §414.1235(a)(1) through (5) in the VM.

Comment: Some commenters opposed our proposal to in clude certain part-year Medicare FFS beneficiaries in the five total pe r capita cost measures because they believe the inclusion of these typically hi gher cost beneficiaries would in appropriately disadvantage groupsCMS-1612-FC 1035

that treat a large percentage of beneficiaries at the end of life. We also received comments in support of our proposal to include certain part-year beneficiaries. These commenters stated that it is important to include as many Medicare bene ficiaries in the cost measure calculations as feasible and especially important to capture th e often significant costs incurred by beneficiaries

at the end of life. One commen ter suggested that we should deve lop an end of life specific cost and quality measure rather than including these cost s in the per capita cost measures. We did not receive any comments in opposition to the inclusion of newly eligib le beneficiaries in the five total per capita cost measures . One commenter indicated that they do not understand why we would exclude any of the part-year beneficiaries, stating that if we can impute costs for some part-year beneficiaries, we should be able to do so for all part-year beneficiaries. Response: We appreciate th e support of commenters w ho supported our proposal to include some part-year benefici aries in the five total per capita cost measures. Part-year

beneficiaries include those who receive end-of-l ife care, which has been correlated with highcost episodes of care. 24 However, analysis submitted to the Institute of Medicine produced an inconclusive causal relationship between the end of a beneficiary’s life and the cost of that

care. 25 Indeed, research refutes the assumption that Medicare beneficiaries near the end of life have substantially similar health statuses. 26 Rather, prior diagnoses, a characteristic that we currently adjust for in the VM, accounts for a subs tantial percentage of the geographic variation in the end-of-life costs. In other words, we be lieve that the risk adjustment system under the VM program explains approximately the same extent of costs in the genera l Medicare population as it

24 Congressional Budget Office, “High-Cost Medi care Beneficiaries.” Final Paper (May 2005), available at http://www.cbo.gov/sites/defau lt/files/05-03-medispending.pdf 25 Acumen, “Geographic Variation in Spending, Utilization and Quality: Medicare and Medicaid Beneficiaries” (May 2013), available at http://www.iom.edu/Reports/2013/~/media /Files/Report%20Files/2013/GeographicVariation/Sub-Contractor/Acumen-Medicare-Medicaid.pdf. 26 Reschovsky JD, et al. “Geographic Variation in Fee-for- Service Medicare Beneficiaries’ Medical Costs Is Largely Explained by Disease Burden.” Med. Care Res. & Rev. 2013; XX,1-22.CMS-1612-FC 1036

does for the cohort of Medicare bene ficiaries near the end of life. 27 In response to concerns raised by commenters, we conducte d additional analyses to ensure the inclusion of part-year beneficiaries does not inappropriate ly negatively impact certain groups or solo practitioners. This analysis, which we plan to post to the Value Modifier website in the near future, showed moderate reliability for the five per capita cost measures continued to be high with the inclusion of certain part-year beneficiaries. For exampl e, for the overall per capita cost measure, 83 percent of TINs had reliability equal to or hi gher than 0.4 when these part-year beneficiaries were included. We agree that it is important to capture as many beneficiaries and costs in these measures as is reasonably possible especially as the number of beneficiaries new to Medicare increases and we continue to agree with the NQF’s recommendation to capture end of life costs

in our measures. We believe that the inclusion of newly eligible benefici aries, who are typically much lower cost and a growing portion of the Medicare program, may offset some of the

increased costs associated with beneficiaries at the end of life. We a ppreciate the suggestion to include cost and quality measures that specifica lly measure care at the end of life and will take

this into consideration as we continue to de velop the VM program. We also appreciate the comments in support of including other part-year beneficiaries in our measures and we will

continue to look into this possibility. We are finalizing our policies as prop osed. Beginning in the CY 2017 payment adjustment period, we will include certain part-year beneficiaries in the five total per capita cost measures under §414.1235(a)(1) thr ough (5). These part-year bene ficiaries include Medicare

FFS beneficiaries who are at the end of life in the performance pe riod and Medicare FFS beneficiaries who are newly enrolled in Medicar e during the performance period and enrolled in

27 Medicare decedents and Medicare survivors with similar diagnoses and utilization in the previous year had substantially similar cost profiles. Hogan C, et al. “Medicare Beneficiaries’ Costs of Care In the Last Year Of Life.” Health Affairs. 2001; 20, 188-195.CMS-1612-FC 1037

both Part A and Part B wh ile in Medicare FFS. In this final rule with comment period, we chose not to address the other concerns about the total per capita cost measures that were raised by NQF. Fi rst, we deferred addressing the issue of whether to incorporate socioeconomic status in our measures until after the NQF has finalized its guidance regarding risk adjustment for resource use measures. Second, we did not propose to include Part D data in the total per capita cost measures at this time due to the complexity of the issue and uncer tainty of how to fairly and e quitably incorporate the costs. Based on data compiled by the Medicare Paym ent Advisory Commission (MedPAC), we estimated that approximately 60 percent of Medicare FFS benefici aries were enrolled in standalone Part D in 2013. 28 A significant minority of beneficiar ies has prescription drug coverage

from a source that is outside of Medicare – su ch as through retiree coverage from a former employer – but for which Medicare does not have access to the data. Including Part D data would incorrectly indicate higher costs for these beneficiaries with Part D coverage relative to otherwise comparable beneficiar ies without such coverage and for whom prescription drug costs cannot be measured directly by CMS. Before we are able to propose inclusion of Part D data, we would need to determine an approach to a ddress this issue. We welcomed comments on suggested methods for including Part D data in the total per capita cost measures. Comment: Many commenters expr essed concern that we are not currently including Part D expenditures in our cost measures. These commen ters stated that the exclusion of Part D costs could push providers to prescribe Part D drugs even when the Part B drug is more appropriate for the patient. Additionally, commenter stated that they believe the exclusion of Part D unfairly

28 Please see http://www.medpac.gov/documents/Mar14_EntireR eport.pdf for underlying data. We estimated that there were 37.3 million Medicare FFS be neficiaries by subtracting the number of beneficiaries enrolled in Medicare Advantage (14.5 million) from the estimated total number of Medicare beneficiaries using data in table 13-1 (P. 328). We estimated that there were 22.4 million beneficiaries with a stand-alone prescription drug plan, which represented 64 percent of the 35 million beneficiaries with Medicare Part D coverage (p. 355).CMS-1612-FC 1038

harms providers that see sicker patients because th ey believe that these patients are more likely to require Part B medications. Several commente rs suggested that CMS either include Part D costs or exclude Part B drug costs. Others sugge sted excluding only those Part B costs for drugs that have a Part D equivalent or capping the Part B costs for certa in high cost drugs. We did not receive any comments specifically recommending an approach for how Part D costs could be

included in our cost measurement. Response: We appreciate the co mments and understand the con cerns raised in regard to exclusion of Part D costs. We remain committed to capturing a full picture of the total cost of care and to assessing cost in a fa ir and consistent manner. We are actively investigating options for operationally including Part D costs in ou r cost measures and would propose any viable options under future notice and comment rulemaking. Comment: We received many comments em phasizing the importance of including

socioeconomic status in our measures. Commenters believe that this is critical to accurately comparing performance between providers that serve different popula tions. One commenter

stated that socioeconomic status should be used in risk adjusting outcomes measures but should not be used in process measures. Response: As noted above, we will continue to consider whether it would be appropriate to apply a socioeconomic status adjustment to the measures included in the VM. In August 2014, NQF released a report on th is topic with recommendations for the development of socioeconomic risk adjustment methodologies 29 . Consistent with that report, we believe it is important to proceed cautiously on this quest ion. We will take the re commendations in this

29 National Quality Forum, “Risk Adjustment for Socioeconomic Status or Other Sociodemographic Factors.” Final Report (2014), available at http://www.qualityforum.org/Publications/2014/08/Risk_Adjustment_for_Socioeconomic_Status_or_Other_Sociode mographic_Factors.aspxCMS-1612-FC 1039

report into account as we consider potential future refinements to our risk adjustment methodologies. Any changes would be made through rulemaking. We also received the following comment, which we believe is outside of the scope of our proposals:

Comment: One commenter stated that CMS should revise our attr ibution methodology to look at “allowed services,” rath er than “allowed charges.” Th e commenter believes that by looking at “allowed charges” we may be inaccurate ly attributing beneficiaries to the provider that bills using higher leve l E&M codes, rather than the provider that sees the patient most often. Response: We believe that a focus on allowed ch arges is appropriate for attribution in Medicare payment measures, because the intent is to a ssess which eligible professional should be held accountable for the payments made. Further, the use of allowed charges in the scenario presented by the commenter would further incenti vize providers to correctly code E&M services

rendered. k. Discussion Regarding Treatment of Hospital-Based Physicians We considered including or allowing groups that include hospital-based physicians or solo practitioners who are hospital-based to elect the inclusion of Hospital Value-Based Purchasing (VBP) Program performance in their VM calculation in future years of the program. We stated that would include hospital performan ce for the hospital or hospitals in which they practice. We would propose such a change through future notice and comment rulemaking, taking into consideration public comment and any re levant empirical eviden ce available at that time. We considered this poten tial policy to expand the perfor mance data included for hospitalbased physicians and to better align incentives fo r quality improvement and cost control across CMS programs. Such a policy would also addr ess public comments we received on the CY 2014 PFS proposed rule (78 FR 74775), suggesting that the Hospital VBP Program total performanceCMS-1612-FC 1040

score for the hospital in which a specialist prac tices should be used in the VM. Commenters made this suggestion, noting that there were lim ited measures that apply to certain specialties and that those specialties may exercise wide influence over the quality of care provided in a hospital. We noted that a hos pital’s final Hospital VBP Program performance for a given performance period would not be available to a gr oup at the time that they registered for PQRS reporting, so if we were to establish a volunt ary policy where groups c ould elect to include hospital performance, they would make the electi on to have that performance included in their VM for a payment adjustment period based on th e hospital’s historic VBP Program performance

which would be known to the TI N at the time of election. We sought public comment on the appropria te methodology to iden tify hospital-based groups and solo practitioners fo r the purpose of having Hospital VBP Program data included or allowing them to elect inclusion of Hospital VB P Program performance data in the VM at the TIN level (70 FR 40511-40512). We s uggested that we could either allow self-nomination or set a threshold based on physician billing, in orde r to determine whether a given physician was hospital-based. We sought comment on whethe r we should set a threshold for a certain proportion of a group’s physicians that would have to meet the criteria, in order for hospital-level performance to be included in the group’s VM calculation. We also sought comment on whether

to use a set of criteri a to determine whether non-physician eligible pr ofessionals should be allowed to self-nominate or should automatically have hospital-level performance data included in the calculation of their VM. We request ed public comment on potential methods for determining which hospital or hospitals’ Hospit al VBP Program performance data should be included in a physician TIN’s VM and how to we ight the hospitals, if more than one was included (79 FR 40512). We welcomed public co mment on the approaches we considered, as well as alternative approaches fo r inclusion of all or part of the Hospital VBP Program TPS intoCMS-1612-FC 1041

the VM. In the interest of aligning the HVB P and VM programs, we sought public comment on

what criteria we should consider in selecting a subset of Hosp ital VBP Program measures or domains in the VM, if we were to adopt such a policy. Finally, we requested public comment on the most appropriate approach for including Ho spital VBP Program performance into a TIN’s

VM. Comment: Commenters generally suppor ted including the Hospital VBP Program performance in the VM, suggesting that it be made voluntary for physicians who meet some threshold of services rendered in the hospita l setting. Commenters stated that a 90 percent threshold would be too high. Response: We appreciate the co mments and will take these into consideration as we continue to refine the VM program and impr ove the coordination between the HVBP and VM programs. We would propose any policy ch anges through future notice and comment rulemaking. 5. Physician Feedback Program Section 1848(n) of the Act requires us to pr ovide confidential repo rts to physicians (and, as determined appropriate by the Secretary, to groups of physicians) that measure the resources involved in furnishing care to Me dicare FFS beneficiaries. Sec tion 1848(n)(1)(A)(i ii) of the Act

also authorizes us to include information on the quality of care fu rnished to Medicare FFS

beneficiaries. a. CY 2013 Quality and Resource Use Reports Based on CY 2013 Data and Disseminated in CY

2014. In September 2014, we made available the QRURs based on CY 2013 data to all physicians (that is, TINs of any size) even though groups with fe wer than 100 eligible professionals will not be subject to the VM in CY 2015. These reports provide clinicallyCMS-1612-FC 1042

meaningful and actionable information on several as pects of the performance of a group practice or solo practitioner. The reports present not only data assessing a group practice’s or solo practitioner’s performance on cost measures and information about the services and procedures contributing most to beneficiarie s’ costs, but also provide data on their performance on quality measures they report under the PQRS as we ll as the three outcome measures under §414.1230. For groups of 100 or more eligible professionals that are subject to the VM starting in 2015, the QRURs provide information on how the group’s qua lity and cost performance affects their physicians’ Medicare payments in 2015. The reports also contain additional supplementary information on the specialty adjusted benchmarks ; inclusion of the individual PQRS measures for informational purposes for EPs reporting PQRS measures as individua ls; enhanced drill down tables; and a dashboard with key performance measures. The reports are based on the VM policies that were finalized in the CY 2013 PFS final rule (77 FR 69310) for physician payment adjustments under the VM beginning January 1, 2015, and they provide groups with an opportunity to see how the policies adopted will apply to them. b. Episode Costs and the Supplemental QRURs Section 1848(n)(9)(A) of the Act requires CMS to develop an episode grouper and include episode-based costs in the QRURs. An episode of care consists of medical and/or procedural services that addre ss a specific medical condition or pr ocedure that are delivered to a patient within a defined time period and are captured by claims data. An episode grouper organizes administrative claims data into episodes. We developed a prototype set of episodes that expands upon the set of episodes that were

described in the CY 2014 PFS final rule with comment period (78 FR 74785). In summer 2014, we distributed Supplemental QRURs based on 2012 data to a greater number of groups (groupsCMS-1612-FC 1043

with at least 100 EPs 30 EPs) that included a broader set of episodes than the 2011 Supplemental QRURs. In addition to the five clinical c onditions in the 2011 Supplemental QRURs, the 2012 Supplemental QRURs included: chronic congestive heart failur e (CHF); chronic obstructive pulmonary disease (COPD)/asthma; acute CO PD/asthma; permanent pacemaker system replacement/insertion; and bila teral cataract removal with le ns implant. For the 2012 Supplemental QRURs, we broke down these episode types into 20 subtypes altogether. In addition to these 20 episode subtypes, we includ ed in the 2012 Supplemental QRURs 6 clinical episode-based measures that we are adapting from those considered for inclusion in the Hospital VBP program (79 FR 28122 through 28124). We described the 20 episode subtypes and six clinical episode-based measures in the proposed rule and soug ht comment on the three medical and three surgical episode measures that we included in the 2012 Supplemental QRURs. We did not receive any general comments on th e three medical and three surgical episode

measures that we included in the 2012 Supplemental QRURs. Attribution for the six clinical episode-based measures at the group level are the same as the rules used for comparable types of the 20 episode subtypes in the 2012 Supplemental QRURs

as discussed above. Attribution rules varied depending on whether a clinical episode-based measure was one of the three surgical (or proced ural) episodes or one of the three medical (or acute condition) episodes. Further details on a ttribution rules can be f ound in “Detailed Methods of the 2012 Medical Group Practi ce Supplemental Quality and Res ource Use Reports (QRURs)” at http://www.cms.gov/Medicare /Medicare-Fee-for-ServicePayment/PhysicianFeedbackProgram/Episode-Cos ts-and-Medicare-Episode-Grouper.html.

30 For Supplemental QRUR purposes, groups were also incl uded if they did not to participate in multiple accountable care organizations (ACOs) an d did not to participate in more than one of the followi ng initiatives in program year 2012: the Shared Savings Program, the Pioneer Accountable Care Organization (ACO) Model, or the Comprehensive Primary Care Initiative (CPCI).CMS-1612-FC 1044

Specifications for these six clinical episode -based measures, incl uding the MS-DRG and procedure codes used to identify each of the episodes, and details of episode construction methodology, are available in “Detailed Me thods of the 2012 Medical Group Practice Supplemental Quality and Resource Use Reports (QRURs)” athttp://www.cms.gov/Medicare/Medicare-Fee-for-ServicePayment/PhysicianFeedbackProgram/Episode-Costs -and-Medicare-Episode-Grouper.html. We welcomed public comments on these specifications and the construction of the six clinical episode-based measures that we in cluded in the 2012 Supplemental QRURs. The following is summary of the comments we received on these specifications and the construction of the six clinical episode-ba sed measures that we included in the 2012 Supplemental QRURs.

Comment: One commenter stated that because E&M services are used as the basis for attribution for acute and chronic episodes, they believe it is unlikely that most radiology groups

would have a score calculated for these measur es. The commenter also noted that certain procedural episode measures, not currently under consideration for inclusion in the VM, may be calculated for radiology groups. Another comme nter stated that he believes there are

inconsistencies and errors in the attribution methodology used for episode measures. Response: We understand the concerns of sp ecialists, including radiology groups, about the challenge of identifying measures for wh ich they would have a sufficient number of

attributed beneficiaries to have the measures cal culated. We will take these into consideration as

we continue to refine the measures and consider them for future use in the VM. CMS’ episodes will continue to evolve over the coming years as more experience is gained. More information about the Supplemental QRURs can be found atCMS-1612-FC 1045

http://www.cms.gov/Medicare/Medicare-Fee-for-ServicePayment/PhysicianFeedbackProgram/Episode-Cos ts-and-Medicare-Episode-Grouper.html. We will continue to seek stakeholder input as we develop the episode framework. We considered proposing to add episode-based pa yment measures to the VM through future rulemaking for all 12 episode subtypes, or some subs et of these episode subtypes, of the selected respiratory and selected heart conditions that have appeared in both the 2011 Supplemental QRURs and 2012 Supplemental QRURs. These 12 ep isode subtypes include: pneumonia (all), pneumonia without an inpatient hospitalization, pneumonia with an inpatient hospitalization, acute myocardial infarction (now called acute coronary syndrome or ACS), ACS without percutaneous coronary interven tions (PCI) or corona ry artery bypass graf t (CABG), ACS with PCI, ACS with CABG, coronary artery disease (n ow called ischemic hear t disease or IHD), IHD without ACS, IHD with ACS, CABG without pr eceding ACS, and PCI without preceding ACS. Additionally, we are considering proposing to add hospital episode -based payment measures to the VM at a later time, such as the six hospita l episodes described above. We welcomed public comments on the specifications included on the website and the construction of the episodebased payment measures that we considered. The following is summary of the comments we received on the specif ications included on

the website and the construction of the episode-based payment measures that we considered. Comment: Several commenters supported ourcontinued efforts to develop episodebased payment measures. Two of these commenters indicated that they believe these measures will support better coordination of care across settings. One co mmenter suggested that the development of episode measures should follow a similar process to that used for quality measures, including multi-stakeholder expert consensus, evidence-based medicine, and clinical guidelines, as appropriate. We received a fe w comments stating that the episode measuresCMS-1612-FC 1046

should not be included in the VM at this time . Two commenters stated their belief that the episode measures are not currently tied to quality measures and s uggested that we address that concern before incorporating the measures into the VM. Another commenter stated that they believe the episode measures are duplicative of the care already captured in the MSPB measure and expressed concern about the reliability of the measures. This commenter suggested that these measures should be removed from the supplemental QRURs until these reliability concerns

are addressed. Another commenter suggested that CMS conduct a more thorough analysis of the attribution methodology used in the episode meas ures and that we narr ow the scope of the conditions that are currently included in the epis ode measures before introducing them into the

VM. Response: We appreciate the input of commenters. We share the commenters’ beliefs

that coordination across care setti ngs is an important factor in improving quality of care and cost performance. We understand the concerns raised about duplication across cost measures and will

take that and the other feedback we received re garding attribution, tying the cost measures to quality measures and the vetting pr ocess for measures as we continue to refine the measures and

consider them for future use in the VM. Develo ping a more robust set of cost measures for the VM remains an important goal. c. Future Plans for the Physician Feedback Reports In the proposed rule, we stated that we w ill continue to develop and refine the annual QRURs in an iterative manner and we will seek to further improve the reports by welcoming suggestions from our stakeholders. As noted previously, on September 30, 2014, we made available the QRURs based on CY 2013 data to all physicians (that is, TINs of any size) even though groups with fewer than 100 eligible professionals will not be subject to the VM in CY 2015. These reports containCMS-1612-FC 1047

performance on the quality and cost measures used to score the composites and additional information to help physicians coordinate care and improve the quality of care furnished. We also intend to provide semi-annual reports with u pdated cost and utilization data. We will again solicit feedback from physicians and continue to work with our partners to improve them. We note that physicians will have some time to de termine the impact of our revised policies and revise their practices accordingly before the new policies impact them. We look forward to continue working with the physician community to improve the QRURs. We received the following general comments on the Physician Feedback Program: Comment: Many commenters stated their s upport for the Physician Feedback Program and applauded CMS’s efforts to improve the QR URs. Many commenters st ated that we should provide QRURs to providers earlier in the year to give them more time to analyze the results and make adjustments prior to the following calendar y ear. Several commenters also suggested that QRURs should be distributed to all providers , including nonphysician eligible professionals. Some commenters suggested that CMS increase our education a nd outreach efforts to ensure that providers know how to access and use the QRURs. Response: We appreciate commenters s upport for the Physician Feedback Program

and we will take these comments into considerat ion as we continue to develop and improve the Physician Feedback Program. While it is not feas ible to provide the annua l QRURs earlier in the year while still allowing sufficient time for claims run out and reporting period, we are exploring how to provide semi-annual reports that will allo w groups and solo practi tioners to better track their performance on cost and utilization during the year.CMS-1612-FC 1048

O. Establishment of the Federally Qualified Health Center Prospective Payment System (FQHC PPS) In the May 2, 2014 Federal Register , we published the final rule with comment period (79 FR 25436) entitled “Medicare Program; Prosp ective Payment System for Federally Qualified Health Centers; Changes to C ontracting Policies for Rural Hea lth Clinics; and Changes to Clinical Laboratory Improvement Amendments of 1998 Enforcement Actions for Proficiency Testing Referral; Final Rule” (herein, “FQHC PPS final rule”). This final rule with comment period implemented methodology and payment rate s for federally qualified health center (FQHC) services under Medicare Part B beginning on October 1, 2014, in compliance with the statutory requirement of the Affordable Care Act, and contained other provi sions. In this final rule with comment period, we invited comment s on how payment for chronic care management (CCM) services could promote integrated and coor dinated care in FQHCs a nd rural health clinics (RHCs). We also invited comments on the m odification of our proposed policy to allow exceptions to the FQHC PPS per diem payment fo r subsequent illness or injury and mental health services furnished on the same day as a medical visit; the establishment of FQHC G-codes to report and bill FQHC visits to Medicare unde r the PPS; and the modification of our proposed approach to waiving coinsurance for preventive services when furnished with other services under the FQHC PPS. 1. Promoting integrated and c oordinated care in FQHCs and RH Cs through payment for Chronic Care Management (CCM) services. In the FQHC PPS final rule with comment period, we invited comments from FQHCs and RHCs on how payment for CCM services coul d help to promote inte grated and coordinated care in FQHCs and RHCs. We cited the CCM in formation in the CY 2014 PFS final rule with comment period (78 FR 74230) for physicians b illing under the PFS in 2015. We encouragedCMS-1612-FC 1049

FQHCs and RHCs to review this informati on and submit comments to us on how the CCM services payment could be adapted for FQHCs a nd RHCs to promote inte grated and coordinated

care. We received a few comments regarding how the CCM services payment could be adapted for FQHCs in CY 2015 to provide inte grated and coordinated care in FQHCs. Commenters supported adopting the CCM provisi ons in FQHCs but had concerns about the unique challenges FQHCs would face implementi ng these provisions. The following is a summary of these comments.

Comment: Commenters stated that the se ven initiatives outlined in the CY 2014 PFS final rule with comment period are viable in FQHCs, but noted that FQHCs would face unique challenges when implementing this provision. Co mmenters stated that the provisions requiring electronic exchange of information might prove difficult at this time since many FQHCs are using electronic health records but are still working on developing th e interoperability with other providers. Commenters suggested the requirement to provide patients with secure messages via

the internet would be difficult since many FQHC patients are at or below 200 percent of the federal poverty level (FPL) and do not have acce ss to internet or email. For example, a commenter stated that 94 percent of all FQHC patients in one state were below 200 percent of

the FPL in 2012. Commenters s upported adopting thes e provisions for FQHCs and suggested that we implement requirements that do not pla ce an undue burden on the health centers or the patient population. One commenter urged that the additional G-codes for CCM services be

sufficient to cover the associated costs of doc umenting care coordinati on and another commenter expressed concern for appropriate payment and re quested that we develop a risk-adjusted per patient per month CCM fee. Response: We appreciate the comments a nd will take them in to consideration.CMS-1612-FC 1050

2. Exceptions to the per diem FQHC PPS payment for subsequent illness or injury and mental

health services furnished on the same day as a medical visit. FQHCs receive enhanced payment to reflect all costs associated with a visit in a single day by a Medicare beneficiary, regardless of the le ngth or complexity of the visit or the number or type of practitioners seen. Under the all-inclusive rate (AIR ) system, an exception to the one encounter payment per day policy was made for s ituations when a patient comes into the FQHC for a medically necessary visit, and after leav ing the FQHC, has a medical issue that was not present at the visit earlier that day, such as an injury or unexpected onset of illness. In these situations, the FQHC has been pa id separately for two visits on the same day for the same beneficiary. Under the AIR system , we also allowed separate paym ent for mental health services furnished on the same day as a medical visit, separate payment for diabetes self-management training/medical nutrition therapy (DSMT/MNT), and separate payment for the initial preventive physical exam (IPPE). In the FQHC PPS proposed rule, published in the September 23, 2013 Federal Register (78 FR 58386), we stated that 2011 Medicare FQHC claims data was reviewed to determine the frequency of FQHCs billing for more than one visit per day for a beneficiary, and we analyzed the potential financial impact on both FQHCs an d on access to care if billing for more than 1 visit per day for these situations was no l onger permitted. We also considered several alternative options, such as an ad justment of the per visit rate wh en multiple visits occur in the same day, or the establishment of a separate per visit rate for subs equent visit due to illness or injury, mental health services, DSMT/MNT, or IPPE. An analysis of data from Medicare FQHC claims with dates of service between January 1, 2011 and June 30, 2012, indicated that multiple visits billed on the same day constituted less than 0.5 percent of all visits, even t hough the ability to do so has been in placeCMS-1612-FC 1051

since 1992 for subsequent illness/injury, since 1996 for mental health services, and since 2007

for DSMT/MNT. We concluded that even allowing for any underrepo rting in the data, eliminating the ability to bill fo r multiple visits on the same day would not significantly impact either the FQHC payment or a beneficiary’s access to care. Therefore, we proposed to revise §405.2463(b) to remove the exception to the single encounter payment per day for FQHCs paid under the proposed PPS, and we stated that this policy is consistent with an all-inclusive methodology and reasonable cost principles and would simplify billing and payment procedures. In the FQHC PPS proposed rule, we solici ted comments to address whether there are

factors that we have not consider ed, particularly in regards to the provision of mental health services, and whether this change would impact access to these services or the integration of

services in underserved communities. Although we did not receive any information th at showed a direct link between multiple billing on the same day and increasing access to care, we modified our proposal in the final rule and stated that we will allow separate billing fo r subsequent illness or injury occurring on the same day as another medical visit. We also modi fied our proposal in the FQHC PPS final rule to allow separate billing for mental he alth services furnished on the same day as a medical visit, as

the comments we received led us to conclude that this had the potential to increase access to care, even if the current claims data did not show that this option was bei ng utilized. We invited

comments on these modifications. We received many comments on the modificatio ns to our proposed policy, which would allow an exception to the per diem PPS payment fo r subsequent injury or illness and for mental health services furnished on the same day as a medical visit. All of the commenters were supportive of this modification; however, mo st of the commenters requested additional exceptions to the per diem PPS payment. The following is a summary of these comments.CMS-1612-FC 1052

Comment: Most commenters strongly supporte d our decision to allow separate payment for subsequent injury or illne ss and mental health services furnished on the same day as a

medical visit. Commenters stated that allowi ng separate payment for mental health services when primary care services are furnished would f acilitate integrated a nd comprehensive health care to Medicare beneficiaries, and agreed with our assertion that separate payment for mental health services has the potential to increase access to mental health services in underserved areas.

The commenters also stated that our modificatio n demonstrated our commitment to the value of furnishing mental health services in FQHCs. Many of the commenters who supported our modi fication allowing subsequent injury or illness and mental health services to be billed separately when furnished on the same day as another billable visit also requested additional exceptions to the PPS per diem payment system. They noted that under the AIR payment system , DSMT/MNT services and the IPPE can be billed separately when furnished on the same day as another billable visit, and requested that these services also have an exception under th e PPS. Commenters particularly emphasized the need for separate payment for DSMT/MNT servi ces and suggested that not being able to bill separately for a DSMT/MNT visit that occurs on the same day as another billable medical visit would deter efficient prov ision of these services. Response: We appreciate the support for allowing an excepti on to the per diem payment when a subsequent injury or illness occurs and fo r mental health services furnished on the same day as a medical visit. Commenters are correct that IPPE and DSMT/MNT can be billed as a separate visit under the AIR payment system when furnished on the same day as another medical visit, and

that we did not include IPPE or DSMT/MNT in the exceptions under the PPS. As explained in the FQHC PPS proposed rule, an analysis of claims data from FQHCs indicated that theCMS-1612-FC 1053

estimated cost per encounter was approximately 33 percent higher when a FQHC furnished care to a patient that was new to the FQHC or to a beneficiary receiving an IPPE or an annual wellness visit (AWV). If we allowed FQHCs to b ill separately for an IPPE that occurred on the same day as another medical visit, we would be overpaying the FQHC for the cost of the IPPE. To accurately pay FQHCs for the costs of furnishing an IPPE, we added an adjustment factor of

1.333 to the PPS rate when an IPPE is furnished at a FQHC. We also extended the adjustment

factor to both initial and subs equent AWVs, in order to appropr iately compensate FQHCs for the costs of furnishing these services. In the FQHC PPS proposed rule and final rules, we discussed that we did not include an exception to the per-diem payment for DSMT/MNT because an analysis of the claims and cost reporting data did not jus tify either a separate per-diem pa yment or an adjustment to the PPS

rate. We also stated our belief that a DSMT/MNT visit is part of the broad category of primary

care services that are included in the services of a FQHC and are part of the PPS per diem payment. We noted that visits with multiple pr actitioners that occur on the same day, including

visits for different conditions or visits with a specialist physician, are not separately payable in a FQHC, and we do not believe that DSMT/MNT vi sits should be considered differently than other primary care services. Although the comments we received did not pe rsuade us to allow DSMT/MNT to be billed separately in a FQHC when it occurs on th e same day as another billable medical visit, or to add an adjustment to the PPS rate for DSMT /MNT when it is furnished on the same day as another billable visit, we believe it is a valuable service, particularly in FQHCs that serve areas with high rates of people with diabetes and rela ted illnesses, and we encourage FQHCs to furnish this service as necessary. We are retaining §405.2463(c)(4)(i) and §405.2463(c )(4)(ii) as finali zed in 79 FR 25478,CMS-1612-FC 1054

which states that for FQHCs billing under the PPS, Medicare pays for more than 1 visit per day when the patient (i) suffers an illn ess or injury subsequent to the fi rst visit that requires additional diagnosis or treatment on the same day; or (ii) ha s a medical visit and a mental health visit on the same day. 3. Establishment of FQHC G-codes to report an d bill FQHC visits to Medicare under the PPS. In the FQHC PPS proposed rule (78 FR 58386), we cited section 1833(a )(1)(Z) of the Act and proposed that Medicare payment under the F QHC PPS would be 80 percent of the lesser of the provider’s actual charge or the PPS rate. Co mmenters were concerned that comparing actual charges with a bundled PPS rate would distort th e true cost of services furnished and would result in FQHCs either being forced to increa se their charges, or receive payment far below actual cost of furnishing services. In response to these comments, we established a new set of HCPCS G-codes to report an estab lished Medicare patient visit, a ne w or initial patient visit, and

an IPPE or AWV. We stated that a FQHC would set its charge for the specific payment codes based on its own determination of what would be appropria te for the services nor mally provided and the population served at that FQHC, and that the char ge for a specific payment code would reflect the sum of regular rates charged to both bene ficiaries and other paying patients for a typical bundle of services that would be furnished per diem to a Medicare beneficiary. We emphasized that the use of these payment codes does not dict ate to providers how to set their charges, and that detailed HCPCS coding with the associated line item charges would c ontinue to be required along with the payment codes when billing Medicare under the PPS. Medicare would pay FQHCs 80 percent of either the actual charge reported for the specific payment code or the PPS rate on each claim, whichever is lower. We stated that establishing HCPCS G-codes for FQHCs to re port and bill for MedicareCMS-1612-FC 1055

visits would allow comparison between the PPS pe r diem rate and a FQHC’s charge for a per diem visit (as defined by the specific payment codes), and that this would be responsive to

commenters’ concerns. As we did not propose the establishment of HCPCS G-codes in the proposed rule, nor did we receive public commen ts specifically requesting such codes, we invited comments on the establishment of G-codes for FQHCs to report and bill FQHC visits to Medicare under the FQHC PPS. We received several comments on the establishment of G-codes for FQHCs to report and bill FQHC visits to Medicare under the FQHC PPS. Most commenters favored using G-codes to report and bill FQHC visits under the PPS; however , commenters expressed concerns about the complexity and administrative burden of implem enting these codes. The following is a summary

of these comments. Comment: Commenters appreciated that we carefully considered the comments related to the Medicare claims payment process and prefer our development of FQHC payment G-codes to compare the FQHC PPS encounter-based rate with the FQHC’s actual charges. Commenters stated that the use of G-codes to implement the “lesser of” provision of the statute is a positive solution that allows for parity between the PPS payment rate and the actual charges being compared. Commenters stated that we resolved what they believe woul d have resulted in an “apples to oranges” comparison by implementing a system that compares the PPS per diem rate, defined by the specific payment HCPCS G-codes, to a FQHC’s actual charge for a per diem

visit. Although many of the commenters were supportiv e of the establishment of G-codes for FQHCs to report and bill FQHC visits to Medicare under the FQHC PPS, many of these commenters stated that the process of developing charges for typical bundle s of services will be complex for FQHCs. Commenters stated that FQHCs have had limited experience working withCMS-1612-FC 1056

payors who use a “lesser of” or “actual ch arges” payment methodology. Commenters acknowledged that Medicare regul ations require that charges must be neutral among payors; however, given that other payors and paying pati ents would not be purchasing a precise bundle of services corresponding to th e Medicare FQHC visit, commenter s stated that the policy to develop G-codes charges is not straightforward. Commenters stated that the charges developed for the FQHC payment G-codes would not be us ed for any non-Medicare pa tient. Commenters

also stated that it would be challenging for FQHCs to develop charges for a typical bundle of services and adhere to requirements under sectio n 330 of the Public Health Service (PHS) Act, which requires FQHCs to develop ch arges consistent with locally prevailing rates that cover their reasonable costs of operation. Co mmenters stated that in deve loping actual charges, FQHCs would need to perfect their codi ng capabilities and appropriately capture the bundle of services they provide in the charges. Although some commenters emphasized the complexity of developing G-code charges, a few commenters a ppreciated that we did not establish precise methods for FQHCs to develop their own G-code charges. Response: We understand that developing G-codes for FQHC payment under the PPS is unfamiliar to FQHCs. To assist FQHCs in unders tanding the new payment system, we held two national training sessions which provided detailed examples of various billing scenarios. A transcript of the presentations and slides from the presentation are posted on our website at http://www.cms.gov/Medicare/Medicare-Fee- for-Service-Payment/FQHCPPS/index.html

. Additional information is available in the “Med icare Benefit Policy Manual, Chapter 13 - Rural Health Clinic (RHC) and Federally Qualifie d Health Center (FQHC) Services,” and the “Medicare Claims Processing Manual, Chapter 9 - Rural Health Clinic (RHC)/Federally Qualified Health Center (FQHC). ” In the resources, we discuss the need for each FQHC to select a bundle of services that reflects a typica l bundle of services that they would provide to aCMS-1612-FC 1057

new or established Medicare patient at their FQHC for medical a nd mental health services and

IPPE and AWV. We also addre ss how FQHCs set their own charge s (which must be consistent with the requirements under sec tion 330 of the PHS Act when a pplicable), and since charges must be the same for all patient s, the charges for the services that are included in the bundle would be totaled to determine the G-code payment amount. We expect that once FQHCs set their charges and select the bundle of services that will be incl uded in the FQHC G-codes, they will adapt well to the process. We would also no te that other payors coul d choose to utilize the FQHC payment G-codes if they choose. Comment: Many commenters suggested that the use of FQHC pa yment G-codes would create an additional administrative burden for FQHCs’ coding and billing staff. Commenters stated that FQHCs will need to spend additiona l time explaining the charges on the Explanation of Benefits (EOB) to Medicare beneficiaries sinc e there could be additional charges beyond what the beneficiary typically sees associated with a vi sit. Some commenters stated that using FQHC payment G-codes could artificia lly inflate FQHCs’ total gross charges, although others stated that some of the financial discrepancies in paym ent would be resolved on ce the FQHC receives payment. However, many commenters stated th ere would be an administrative burden to a FQHC in the short-term as it attempts to re solve balances and financial statements. Response: FQHCs may initially have to spend additional time explaining changes in charges and the patient’s EOB, and we encourage them to keep their patients informed of any changes. We also acknowledge that transitioning to a new payment system will require additional time and patience as all aspects of the billing system will need to be adapted. We noted in the FQHC PPS final rule that although FQHCs set their own charges, FQHCs that receive grant fundi ng under section 330 of the PHS Act are required to maintain charges that are both consistent with locally prev ailing rates or charges an d are also reflective ofCMS-1612-FC 1058

their reasonable costs of operation. Therefore, we do not expect that the FQHCs will use the payment G-codes to artificially inflate their charges.

Comment: Several commenters were concerne d that the use of G-codes would limit the definition or scope of a qualifying face-to-face visit. Commenters stated that we were limiting the scope of FQHC services by requiring that only certain HCPC S codes support the use of each FQHC payment G-code. Commenters stated th at services described by codes other than evaluation and management (E/M) se rvices also meet the definition of a face-to-face visit with a qualifying provider. The commenters recommende d that for each qualifying visit, the FQHC

should be able to ente r the corresponding FQHC payment G-code to be eligible for payment. Response: We disagree that the new PPS may limit the scop e of FQHC services. All services that qualified as a bill able visit under the AIR payment sy stem continue to qualify as a

billable visit under the PPS. There has been no change to the scope of services that may be furnished in a FQHC and no change in the type of vi sits that qualify as a billable visit as a result of the new payment system. Since the previous payment system did not utilize HCPCS coding to determine payment, we anticipate the new payment system will be more transparent, as all

services furnished must have the correct HCPC S codes for accurate payment, along with the appropriate G-code for payment. We would also note that in addition to E/M visits, there are many preventive services that can be billed as stand-alone visits in FQHCs under both the AIR and PPS payment systems.

Comment: A few commenters s uggested that we develop mo re G-codes to account for other types of services furnished in a FQHC and G-codes that address varying patient populations. One commenter sugges ted that we add an additional 10 to 15 HCPCS codes based on the historical claims data for FQHC visits. Another commenter suggested that due to the complex needs of their FQHC patient populat ion, additional FQHC payment G-codes shouldCMS-1612-FC 1059

reflect multiple services, intensity, and cost of furnishing services to their complex patient population. Response: We stated in the FQHC PPS propos ed and final rules that our goal for the FQHC PPS is to implement a system in accordan ce with the statute whereby FQHCs are fairly paid for the services they furnish to Medicare patients in the least bur densome manner possible, so that they may continue to furnish primary a nd preventive health services to the communities they serve. In developing the FQHC G-codes, we considered whether there should be fewer G-codes, or more G-codes, than the five that we ultimately proposed. The G-codes are designed to reflect a typical bundle of serv ices that a FQHC furnishes to their Medicare patients, and we determined that having more G-codes would be burdensome without providing any advantage in payment accuracy. However, we will monitor the PPS system and will consider adding additional G-codes if necessary.

Comment: A number of comment ers requested clarification th at the bundle of services

taken into account in the G-code charge reflects the total bundle of services for a FQHC visit, rather than just the services furnished on that day. Some commenters also sought clarification on billing the professional component of a preventive servi ce on a day subsequent to the day of the

visit. These commenters are concerned whet her under the new billing requirements for the FQHC PPS all services are meani ngfully included in the encount er payment rate even when a component of the service is furnished on a di fferent date than the actual visit. Response: The FQHC G-codes reflect the services that the FQHC typically furnishes to a Medicare patient that is either a new or established, medical or me ntal health patient or a patient receiving an IPPE or AWV. This may be the sa me bundle of services that are furnished to the patient on a particular day, but is not required to be the same se rvices, as the patient may need more, fewer, or a different set of services on that particular day.CMS-1612-FC 1060

FQHCs may bill for services furnished incident to a visit on the same claim, even if they occur on a different day, as long as the services are furnished in a medically appropriate time frame. For example, if a patient has their blood drawn at the FQHC on a Monday, and sees the FQHC practitioner the following Wednesday, the FQHC would include the venipuncture on the

same claim as the visit with the practitioner. The FQHC G-codes are defined in program inst ructions in accordance with statutory and regulatory requirements and will be implemented as described. 4. Waiving coinsurance for preventive services when furnished with other services under the FQHC PPS. In the FQHC PPS proposed rule (78 FR 58386), we proposed that for FQHC claims that include a mix of preventive and non-preventive services, FQHCs would use payments under the PFS to determine the proportional amount of coinsu rance that should be waived for payments

based on the PPS encounter rate. Since Medicare payment under the FQHC PPS is required to be 80 percent of the lesser of the FQHC’s char ges or the PPS rate, we proposed that we would continue to use FQHC-reported charges to determ ine the amount of coinsurance that should be waived for payments based on the FQHC’s ch arge, and that total payment to the FQHC, including both Medicare and beneficiary liabi lity, would not exceed the lesser of the FQHC’s charge or the PPS rate. We acknowledged that our proposed approach for waiving coinsurance for preventive

services when furnished with other services was complex and may be difficult for FQHCs to implement, and we invited public comment on how this proposal would impact a FQHC’s administrative procedures and billing practices . Commenters responded that the proposed system to calculate coinsurance was too co mplex and burdensome and requested that a simplified system be established.CMS-1612-FC 1061

In the final rule referenced above, we agreed with the commenters, and decided to retain the current method used under the AIR system for calculating coinsurance, with certain modifications. Under the new FQHC PPS, the do llar value of the FQHC’s reported line-item charge for the preventive service will be subt racted from the full payment amount, whether payment is based on the FQHC’s charge or the PPS rate. Medicare will pay the FQHC 100 percent of the dollar valu e of the FQHC’s reported line-item ch arge for the preventive service, up to the total payment amount. Medicare also wi ll pay a FQHC 80 percent of the remainder of the full payment amount, and beneficiary coinsuranc e would be assessed at 20 percent of the remainder of the full payment amount. If the re ported line-item charge for the preventive service equals or exceeds the full payment amount, Medi care will pay 100 percent of the full payment amount and the beneficiary will not be responsible for any coinsurance. We believe that this revised methodology is responsive to commenters request for a simpler method of calculating coinsurance and will be more transparent to beneficiaries. We invited comments on this approach to waiving coinsurance for preventive services based on the dollar value of the FQHC’s reported line- item charge for preventive services. We received many comments on how our finalized policy for calculation of coinsurance for preventive services would affect a FQHC’s ad ministrative procedures and billing practices. Most commenters appreciated that we are striving for policies th at ease administrative burden; however, many of the commenters thought that our revised approach is still too complex and burdensome to implement. The following is a summary of these comments. Comment: Most commenters suppo rted that we are striving fo r a waiver of coinsurance calculation that achieves greater simplicity and pr omotes fair payment under Medicare. A few commenters stated that our revised approach is a common sense and workable approach to applying this important provision. One commenter stated that this approach would allow forCMS-1612-FC 1062

FQHCs to assess coinsurance at the time services are furnished, potentially increase rates of collection, and reduce administra tive burden. Commenters who s upported the revised approach requested that we closely monito r how the waiver of coinsurance is calculated and determine if

further modifications are needed in the future. Most commenters preferre d the revised approach, but some expressed concern that it is still too complex and burdensome. Commenters stated that our methodology for the calculation of coinsurance waiver when th e services include a mix of preventive and non-preventive se rvices is too complex for th e FQHC staff to accurately

determine the coinsurance at th e time services are furnished. Commenters suggested that FQHCs would be concerned with overcharging th e patient and waive all coinsurance when a mixture of preventive and non-preventive services is furnished. Commenters acknowledged that FQHCs could bill the patient after the MAC issues a remittance advice, but the commenters

stated that this would increase bad debt. One co mmenter stated that the revised approach creates an incentive for FQHCs to offer fewer services at each visit and request patients to return on different days for additional services that could have been furnished on the same day. Response: We appreciate that FQHCs want to accurately determine coinsurance amounts when there is a mix of preventive and non-preventive services furnished on the same day so that

beneficiaries are neither overcha rged nor undercharged. Since FQHCs set their own charges and develop their own G-codes, they should be able to accurately determine the coinsurance amount. We believe that the proposed method strikes th e right balance between accuracy and simplicity, and we will make adjustment as necessary if pr oblems arise. We also note that, under certain circumstances, FQHCs may waive coinsura nce amounts for Medicare and Medicaid beneficiaries (see for example, section 1128B(b )(3)(D) of the Act and § 1001.952(k)(2) of the regulations). Also, most FQHCs are subject to the statutor y and regulatory requirements of the Health Center Program (section 330 of th e PHS Act; 42 CFR Part 51c; and 42 CFR 56.201CMS-1612-FC 1063

through 56.604), which, among other requirements, ma ndates that they may collect no more than

a ‘‘nominal fee’’ from individuals whose annual income is at or below 100 percent of the Federal Poverty Level.” We are not clear why one commenter suggested that the method for calculating

coinsurance could create an incentiv e for FQHCs to offer fewer serv ices at each visit and request patients to return on different da ys for additional services that could have been furnished on the same day. However, as we stated in the FQHC PPS final rule, we expect FQHCs to act in the best interests of their patients , which includes scheduling visits in a manner that maximizes the health and safety of their patients.

Comment: Some comment ers stated that the complexity of our revised approach does not carry out Congressional intent to provide for complete waiver of coinsurance when covered preventive services are furnished. They stated that when Congress provided for a complete waiver of coinsurance for specifi c preventive services under section 4104 of the Affordable Care Act, it was intended to improve access to thes e services, and that requiring Medicare

beneficiaries be liable for coinsurance when a mi xture of preventive and non-preventive services

are furnished does not remove barriers to these serv ices. Commenters also stated that we lack “any specific statutory authorizat ion to waive coinsurance for se rvices provided under the FQHC PPS,” and therefore, CMS is not barred from im plementing a complete waiver for coinsurance

when a mixture of services are furnished. These commenters stated that a complete waiver of coinsurance for visits involving a preventive se rvice is consistent w ith the regulation under §410.152(l), which states that Medi care Part B pays “100 percen t of the Medicare payment amount established under the applicable paym ent methodology for the service setting for providers and suppliers of the following preventive services.” Commenters stated that a FQHC is a provider of such preven tive services and that the FQHC PPS is an applicable paymentCMS-1612-FC 1064

methodology. Commenters surmised th at it is more consistent with the regulation to completely waive coinsurance for visits involving a mixture of preventive and non-preventive services rather than implement a partia l coinsurance methodology. Response: We disagree with the commenter s’ interpretation that the statutory and regulatory language cited provides us with the authority to waiv e coinsurance for all services when there is a mix of preventive and non-pr eventive services fu rnished during a FQHC

encounter. The revised met hodology for calculating coinsurance when there is a mix of preventive and non-preventive serv ices on the claim was revised in response to commenters’ concerns that the methodology that was first prop osed was overly complex and burdensome. We

believe that the revised methodol ogy is responsive to those c oncerns, and provides as much simplicity as possible while enabling FQHCs to comply with statutory requirements for the

collection of coinsurance. We are retaining §405.2410(b)(2)(i), §405.2410( b)(2)(ii), and §405.2462(d) of the Medicare regulations as finali zed in 79 FR 25475 and will use th e current approach to waiving coinsurance for preventive services, whether total payment is based on the FQHC’s charge or the PPS rate, by subtracting the dol lar value of the FQHC’s repor ted line-item charge for the preventive services from the full payment amount.

5. Other Comments We received many comments requesting that we provide further information through subregulatory guidance to the stakeholder commun ity regarding same-day visits, development of G-code charges, the calculation of coinsurance when a mixture of preventive and non-preventive services are furnished, what is considered th e technical and the professional component of preventive services, billing procedures and proce ssing of claims for same-day visits. Several commenters requested specific examples on calcula ting coinsurance when the claim contains aCMS-1612-FC 1065

mixture of preventive and non-preventive services. Response: The “Medicare Benefit Policy Ma nual, Chapter 13 - Rural Health Clinic (RHC) and Federally Qualified Health Center (FQHC) Services,” and the “Medicare Claims Processing Manual, Chapter 9 - Rural Health Clin ic (RHC)/Federally Qualified Health Center (FQHC), ” are regularly updated and will address these topics. Additional information on the FQHC PPS is available on the CMS website at http://www.cms.gov/Medicare/Medicare-Fee-forService-Payment/FQHCPPS/index.html

. We received some comments that were not related to our specific proposals for the FQHC PPS. Although we appreciate the commen ters’ feedback on billing for vaccines under Medicare part D, billing for co sts relating to language assist ance and other enabling services, adjustments to the California GAF, FQHC P PS rate risk adjusters, and the FQHC PPS implementation date, payment for furnishing servi ces to dually eligible Medicare and Medicaid beneficiaries, these topics are beyond the scope of our specific proposals that we specified were subject to public commen t in the FQHC PPS.

6. Additional Technical Revisions a. SNF Consolidated Billing In this final rule with comment period, we are making a conforming technical revision in §411.15(p)(2) and §489.20(s). In the May 2, 2014, in terim final rule (79 FR 25462), we updated §405.2411(b)(2) so that it reflects section 1888(e) (2)(A)(iv) of the Act (as amended by section 410 of the MMA), which excludes certain RH C and FQHC practiti oner services from consolidated billing and allows such services to be separate ly billable under Part B when furnished to a resident of a SNF during a covere d Part A stay. This statutory provision was

effective with services furnished on or afte r January 1, 2005 and was previously implemented through program instruction (CMS Pub 100–04, Medi care Claims Processing Manual, Chapter 6,CMS-1612-FC 1066

Section 20.1.1). However, in making this revision, we ina dvertently neglected to make a conforming change in §411.15(p)(2), which e numerates the individua l services that are excluded from the SNF consolidated billing provision, as well as in §489.20(s), which specifies compliance with consolidated billing as a require ment of the SNF’s Medicare pr ovider agreement. Accordingly, we are now rectifying that omission. Regarding the technical corrections to pa rts 411 and 489 of the regulations discussed above, we note that we would ordinarily publ ish a notice of proposed rulemaking in the Federal Register to provide a period for public comment before revisions in the re gulations text would take effect; however, we can waive this pro cedure if we find good cause that a notice and comment procedure is impracticable, unnecessar y, or contrary to th e public interest and incorporate a statement of the finding and its reasons in the notice issued. We find it unnecessary to undertake notice a nd comment rulemaking in connect ion with these particular revisions, as they merely provi de technical corrections to th e regulations, without making any substantive changes. Therefor e, for good cause, we waive notice and comment procedures for the revisions that we are making to the regulations text in parts 411 and 489. b. Transitional Care Management In the May 2, 2014 final rule (79 FR 25436), we added transitional care management (TCM) to §405.2463(a)(1)(ii). To clarify that TC M does not necessarily require a face-to-face visit, we revised this section of the regulation for RHCs, but ne glected to add the appropriate reference for FQHCs. Therefore, we are re vising §405.2463(a)(2)(i), so that a FQHC visit includes a qualified TCM service.CMS-1612-FC 1067

P. Physician Self-Referral Pr ohibition: Annual Update to the List of CPT/HCPCS Codes

1. General Section 1877 of the Act prohibits a physicia n from referring a Medi care beneficiary for certain designated health services (DHS) to an entity with which the physician (or a member of the physician's immediate family) has a financia l relationship, unless an exception applies. Section 1877 of the Act also prohibits the DHS entity from submitting claims to Medicare or billing the beneficiary or any other entity for Me dicare DHS that are furnished as a result of a prohibited referral. Section 1877(h)(6) of the Act and § 411.351 of our regulations specify that the following

services are DHS:

● Clinical laboratory services

● Physical therapy services

● Occupational therapy services

● Outpatient speech-language pathology services

● Radiology services

● Radiation therapy services and supplies

● Durable medical equipment and supplies

● Parenteral and enteral nutrients, equipment, and supplies

● Prosthetics, orthotics, and prosthetic devices and supplies

● Home health services

● Outpatient prescription drugs

● Inpatient and outpati ent hospital services 2. Annual Update to the Code List a. BackgroundCMS-1612-FC 1068

In §411.351, we specify that the entire scope of f our DHS categories is defined in a list of CPT/HCPCS codes (the Code List), which is updated annually to account for changes in the most recent CPT and HCPCS Level II publications . The DHS categories defined and updated in

this manner are:

● Clinical laboratory services

● Physical therapy, occupational therapy, and out patient speech-language pathology

services

● Radiology and certain other imaging services

● Radiation therapy services and supplies

The Code List also identifies those items a nd services that may qualify for either of the following two exceptions to the phys ician self-referral prohibition:

● EPO and other dialysis-re lated drugs furnished in or by an ESRD facility (§ 411.355(g))

● Preventive screening tests, imm unizations, or vaccines (§ 411.355(h)) The definition of DHS at §411.351 excludes servi ces that are reimbursed by Medicare as part of a composite rate (unl ess the services are specifically identified as DHS and are themselves payable through a composite rate, such as home health and inpatient and outpatient hospital services). E ffective January 1, 2011, EPO and dialysis -related drugs furnished in or by an ESRD facility (except drugs for which there are no injectable equivalents or other forms of administration), have been reimbursed under a co mposite rate known as the ESRD prospective payment system (ESRD PPS) (75 FR 49030). Acco rdingly, EPO and any dialysis-related drugs that are paid for under ESRD PPS are not DHS and are not listed among the drugs that could qualify for the exception at §411.355(g) for EPO and other dialysis-related drugs furnished by an ESRD facility.CMS-1612-FC 1069

Drugs for which there are no injectable equiva lents or other forms of administration were scheduled to be paid under ESRD PPS begi nning January 1, 2014 (75 FR 49044). However, on January 3, 2013, Congress enacted the Ameri can Taxpayer Relief Act of 2012 (ATRA), (Pub. L.112-240), which will delay payment of these dr ugs under ESRD PPS until January 1, 2016. In the meantime, such drugs furnished in or by an ESRD facility are not re imbursed as part of a composite rate and thus, are DHS. For purpos es of the exception at §411.355(g) , only those drugs that are required for the efficacy of dialys is may be identified on the List of CPT/HCPCS Codes as eligible for the exception. As we have explained previously in the CY 2010 PFS final rule (75 FR 73583), we do not believe any of these drugs are required for the efficacy of dialysis. Therefore, we have not included any such drugs on the list of drugs that can qualify for the exception. The Code List was last updated in Addendum K of the CY 2014 PFS final rule with comment period.

b

. Response to Comments We received no public comments relating to the Code List that became effective January 1, 2014.

c . Revisions Effective for 2015 The updated, comprehensive Code List e ffective January 1, 2015, is available on our

Web site at http://www.cms.gov/Medicare/Fraud-andAbuse/PhysicianSelfRef erral/List_of_Codes.html

. Additions and deletions to the Code List conform it to the mo st recent publications of CPT and HCPCS Level II, and to changes in Medicare coverage policy and payment status. Tables 90 and 91 identify the additions and deletions, respectively, to the comprehensive Code List that become effective January 1, 2015. Tables 90 and 91 also identify the additionsCMS-1612-FC 1070

and deletions to the list of codes used to identify the items and services that may qualify for the exception in §411.355(g) (regarding dial ysis–related outpatient prescr iption drugs furnished in or by an ESRD facility) and in §411.355(h) (regarding preventive screening tests, immunizations, and vaccines). We will consider comments regarding the c odes listed in Tables 90 and 91. Comments

will be considered if we receive them by the date specified in the "DATES" section of this final rule with comment period. We will not consider any comment that advocates a substantive change to any of the DHS defined in §411.351. TABLE 90: Additions to the Phys ician Self-Referral List of CPT 1/ HCPCS Codes

CLINICAL LABORATORY SERVICES 0357T Cryopreservation oocyte(s) PHYSICAL THERAPY, O CCUPATIONAL THERAPY, AND OUTPATIENT SPEECH-LANGUAGE PATHOLOGY SERVICES 97607 Neg press wnd tx </=50 sq cm 97608 Neg press wound tx >50 cm RADIOLOGY AND CERTAIN OTHER IMAGING SERVICES 76641 Ultrasound breast complete 76642 Ultrasound breast limited 77061 Breast tomosynthesis uni 77062 Breast tomosynthesis bi 77063 Breast tomosynthesis bi 77085 Dxa bone density study 77086 Fracture assessment via dxa G0279 Tomosynthesis, mammo screen RADIATION THERAPY SERVICES AND SUPPLIES A9606 Radium Ra223 dichloride ther C2644 Brachytx cesium-131 chloride 77306 Telethx isodose plan simple 77307 Telethx isodose plan cplx 77316 Brachytx isodose plan simple 77317 Brachytx isodose intermed 77318 Brachytx isodose complexCMS-1612-FC 1071

77385 Ntsty modul rad tx dlvr smpl 77386 Ntsty modul rad tx dlvr cplx G6001 Echo guidance radiotherapy G6002 Stereoscopic x-ray guidance G6003 Radiation treatment delivery G6004 Radiation treatment delivery G6005 Radiation treatment delivery G6006 Radiation treatment delivery G6007 Radiation treatment delivery G6008 Radiation treatment delivery G6009 Radiation treatment delivery G6010 Radiation treatment delivery G6011 Radiation treatment delivery G6012 Radiation treatment delivery G6013 Radiation treatment delivery G6014 Radiation treatment delivery G6015 Radiation tx delivery imrt G6016 Delivery comp imrt G6017 Intrafraction track motion DRUGS USED BY PATIENTS UNDERGOING DIALYSIS {No additions} PREVENTIVE SCREENING TE STS, IMMUNIZATIONS AND VACCINES 90630 Flu vacc iiv4 no preserv id G0464 Colorec CA scr, sto bas DNA 1 CPT codes and descriptions only are copyright 2014 AMA. All rights are reserved and applicable FARS/DFARS clauses apply.CMS-1612-FC 1072

TABLE 91: Deletions from the Ph ysician Self-Referral List of CPT 1/ HCPCS Codes

CLINICAL LABORATORY SERVICES 0059T Cryopreservation oocyte PHYSICAL THERAPY, O CCUPATIONAL THERAPY, AND OUTPATIENT SPEECH-LANGUAGE PATHOLOGY SERVICES {No deletions} RADIOLOGY AND CERTAIN OTHER IMAGING SERVICES 74291 Contrast x-rays gallbladder 76645 Us exam breast(s) 77082 Dxa bone density vert fx RADIATION THERAPY SERVICES AND SUPPLIES 0073T Delivery comp imrt 0197T Intrafraction track motion 77305 Teletx isodose plan simple 77310 Teletx isodose plan intermed 77315 Teletx isodose plan complex 77326 Brachytx isodose calc simp 77327 Brachytx isodose calc interm 77328 Brachytx isodose plan compl 77403 Radiation treatment delivery 77404 Radiation treatment delivery 77406 Radiation treatment delivery 77408 Radiation treatment delivery 77409 Radiation treatment delivery 77411 Radiation treatment delivery 77413 Radiation treatment delivery 77414 Radiation treatment delivery 77416 Radiation treatment delivery 77418 Radiation tx delivery imrt 77421 Stereoscopic x-ray guidance G0417 Sat biopsy prostate 21-40 G0418 Sat biopsy prostate 41-60 G0419 Sat biopsy prostate: >60 DRUGS USED BY PATIENTS UNDERGOING DIALYSIS {No deletions} PREVENTIVE SCREENING TE STS, IMMUNIZATIONS AND VACCINES {No deletions} 1 CPT codes and descriptions only are copyright 2014 AMA. All rights are reserved and applicable FARS/DFARS clauses apply.CMS-1612-FC 1073

Q. Interim Final Revisions to the Electro nic Health Record (EHR) Incentive Program 1. Statutory Basis The American Recovery and Reinvest ment Act of 2009 (Pub. L. 111–5) (ARRA)

amended titles XVIII and XIX of the Act to auth orize incentive payments to EPs, eligible hospitals, and critical access hos pitals (CAHs), and Medicare A dvantage (MA) organizations to promote the adoption and meaningful use of CEHRT. Sections 1848(o), 1853(l) and (m), 1886(n), and 1814(l) of the Act provide the statut ory basis for the Medicare incentive payments made to meaningful EHR users. These statutor y provisions govern EPs, MA organizations (for certain qualifying EPs and hospitals that mean ingfully use CEHRT), s ubsection (d) hospitals, and CAHs, respectively. Sections 1848(a)(7), 1853(l) and (m), 1886(b)(3)(B), and 1814(l) of the Act also establish downward payment adjustments, beginning with calendar or fiscal year 2015, for EPs, MA organizations, subsect ion (d) hospitals and CAHs that are not meaningful users of

CEHRT for certain associated re porting periods. Sections 1903( a)(3)(F) and 1903(t) of the Act provide the statutory basis for Medicaid incentive payments, but do not provide for downward payment adjustments. Sections 1848(a)(7)(B), 1886(b )(3)(B)(ix)(II), and 1814(l)(4)(C) of the Act provide that the Secretary may, on a case-by-case basis, exempt an EP, eligible hospital, or CAH that is not a meaningful EHR user for an EHR reporting peri od for the year from the application of the payment adjustment if the Secretary determines that compliance with the requirement for being a meaningful EHR user would result in a significant hardship, such as in the case of an EP, eligible hospital, or CAH that practices or is located in a rural area wit hout sufficient internet access. The exception is subject to annual renewal, but in no case may an exception be granted for more than 5 years.

2. Provisions of the Interim Fi nal Rule With Comment PeriodCMS-1612-FC 1074

a. Extreme and Uncontrollable Circumstances Hardship Exception In the September 4, 2014 Federal Register (79 FR 52910-52933) CMS and ONC published a final rule titled “M edicare and Medicaid Programs; Modifications to the Medicare and Medicaid Electronic Health Record (EHR ) Incentive Program for 2014 and Other Changes to the EHR Incentive Program; and Health Inform ation Technology: Revisions to the Certified EHR Technology Definition and EHR Certification Changes Related to Standards; Final Rule” (“2014 CEHRT Flexibility rule”). The final rule included policies allowing EPs, eligible hospitals, and CAHs that could not fully im plement 2014 Edition CEHRT for an EHR reporting period in 2014 due to issues related to 2014 Editi on CEHRT availability de lays to continue to

use 2011 Edition CEHRT or a combination of 2011 Edition and 2014 Edition CEHRT for the EHR reporting periods in CY 2014 and FY 2014, re spectively. These CEHRT options applied only to those providers that could not fully implement 2014 Edition CEHRT to meet meaningful use for an EHR reporting period in 2014 due to de lays in 2014 Edition CEHRT availability. The final rule also made changes to the attestati on process to support thes e flexible options for CEHRT, although it did not alter th e attestation or hardship excep tion application deadlines for 2014. Therefore, for example, eligible hospitals that never successfully at tested to meaningful use prior to FY 2014 were still re quired to attest by July 1, 2014, and eligible professionals who never successfully attested to meaningful use prior to CY 2014 were required to attest by October 1, 2014, for an EHR reporting period in FY 2014 or CY 2014, respectively, to avoid the Medicare payment adjustments in FY 2015 or CY 2015, respectively. To request a hardship exception from the Medicare payment adjustments in FY or CY 2015, applications were due from eligible professionals by July 1, 2014, eligible hospitals by April 1, 2014, and CAHs by November 30, 2015. In addition, throughout the cour se of the year, we continued to urge providers to purchase 2014 Edition CEHRT and not wait until the last minute to attest for theCMS-1612-FC 1075

EHR reporting period in 2014. However, following publication of the 2014 CEHRT Flexibility rule, we became aware that providers were confused over their ability to use flexible options provided under the 2014 CEHRT Flexibility rule, especially given the unchanged attestation deadlines. We received

numerous letters from various health care associ ations, multiple questions from stakeholders on provider calls, and numerous e-mails from provide rs and EHR vendors, a ll expressing confusion and seeking clarification about whether they could use the flexible options provided under the 2014 CEHRT Flexibility rule. Specifically, prov iders were unsure how they could use the flexible options given that the attestation deadlines for both e ligible professionals (October 1, 2014) and eligible hospitals (July 1, 2014) would ha ve occurred on or before the effective date of the 2014 CEHRT Flexibility rule (October 1, 2014). Providers were extremely concerned that their inability to use the flexible options speci fied in the 2014 CEHRT Flexibility rule would subject them to a payment adjustment in 2015 under Medicare for failing to demonstrate meaningful use of CEHRT. This fear was co mpounded by the fact that the hardship exception application deadlines for both elig ible professionals (July 1, 2014) and eligible hospitals (April 1, 2014) had already passed. In particular, we became aware that eligible professionals who never successfully attested to meaningful use for the EHR Incentive Program we re especially affected by this issue because they would not be able to use the flexibility options outlined in the 2014 CEHRT Flexibility rule before the October 1, 2014 deadline to avoid th e payment adjustment in CY 2015, because these options could not be made available in the CMS Registration and Attestation System prior to the October 1, 2014 effective date of the 2014 CEHRT Fl exibility rule. We also became aware that eligible professionals also faced uncertainty if th ey joined practices that were already using 2011 Edition CEHRT and experienced delays in fu ll implementation of 2014 Edition CEHRT.CMS-1612-FC 1076

Therefore, we understood that eligib le professionals were concerned th at the inability to attest by October 1, 2014 using the flexible options under the 2014 CEHRT Flexibility rule would potentially subject them to th e payment adjustment in CY 2015 authorized under the Medicare EHR Incentive Program if they could not receive a hardship exception. Accordingly, to ensure that all providers can use the flexible opti ons recently finalized under the 2014 CEHRT Flexibility rule for an EHR reporting period in 2014, and ensure that providers are not potentially su bjected to the 2015 payment adjustment under the Medicare EHR Incentive Program, we are recognizing a hardsh ip exception under the established category of

“extreme and uncontrollable circumstances” under 42 CFR § 495.102(d)(4)(iii) for eligible professionals and § 412.64(d)(4)(ii)(B) for eligib le hospitals, pursuant to the Secretary’s discretionary hardship exception authority. Under th is IFC, we will consider that an extreme and uncontrollable circumstance hardship exists for an eligible professional or eligible hospital if two criteria are met. First, the provider must not have been able to fully implement the 2014 Edition CEHRT due to delays in 2014 Edition CEHRT availa bility. Second, the provider must not have been able to attest by their at testation deadline in 2014. For exam ple, for eligible professionals, the eligible professional must not have been able to attest by October 1, 2014 using the flexibility options under the 2014 CEHRT Flexibility rule. For eligible hospitals, the eligible hospital must not have been able to attest by July 1, 2014 us ing the flexibility opti ons under the 2014 CEHRT Flexibility rule. We will recognize an extreme and uncontrollable circumstance hardship exception under this IFC only for those providers meeting both these crite ria and only for the 2015 payment adjustment. For CAHs, although we would recognize a hardship exception fo r CAHs under these circumstances, this exception would have litt le impact on CAHs because the hardship exception application deadline for CAHs for the 2015 paymen t adjustment does not occur until NovemberCMS-1612-FC 1077

30, 2015. Accordingly, CAHs will have ample time to attest using the flexibility options under the 2014 CEHRT Flexibility rule and will not be impacted in the same manner as eligible hospitals or eligible profe ssionals, whose attestation and hardship excepti on application deadlines have since passed. However, as ex plained below, to maxi mize flexibility in the hardship exception application submission process for all providers under the hardship exception categories, so that we avoid similar situations in the future, like the ones prompting this IFC, we are amending §413.70(a)(6) to allow CMS the flexib ility to specify an alternate hardship exception application submission de adline for certain hardship cat egories other than November

30 th

. b. Extension of Hardship Exception Applicat ion Deadline to Novemb er 30, 2014 for Eligible Professionals and Eligible Hospita ls and Amendments to §§495.102, 412.64, and 413.70. Section 495.102(d)(4) provides th e categories of hardship ex ceptions for EPs, including insufficient internet access, newly practicing EP s, extreme circumstances outside of an EP’s control, lack of control over the availability of CEHRT for EPs practicing in multiple locations,

lack of face-to-face patient interactions and l ack of need for follow-up care, and certain primary specialties. With the exception of the newly pr acticing EP hardship exception category, the EP is required to file a hardship exception applicat ion to CMS for the remaining hardship categories no later than July 1 st of the year before the payment adjustment year. Similar to eligible professionals, §412.64( d)(4) provides the categories of hardship exceptions for eligible hospitals, which include insufficient internet access, new eligible hospitals, and extreme and uncontroll able circumstances outside of an eligible hospital’s control. Under the hardship exception categories for insufficient in ternet access and extreme and uncontrollable circumstances, the eligible hospita l is required to file a hardship exception application to CMS no later than April 1 st of the year before the pa yment adjustment year.CMS-1612-FC 1078

Similar to eligible hospitals, §413.70(a)(6) prov ides the categories of hardship exceptions that CAHs could apply for, which include insu fficient internet access, new CAHs, and extreme

and uncontrollable circumstances outside of a C AH’s control. Under al l hardship exception categories, the CAH is required to file a hard ship exception applicati on to CMS no later than

November 30 th after the close of the a pplicable EHR reporting period for a payment adjustment year to be considered for a hardship exception. For purposes of the 2015 payment adjustment under the Medicare EHR Incentive Program, the hardship exception ap plication deadlines for both eligible hospitals and eligible professionals have ended. However, we need to accommodate the extreme and uncontrollable circumstance hardship exception recognized under this IFC. Therefore, for purposes of the 2015 payment adjustment under the Medicare EHR Ince ntive Program, we are extending the hardship exception application submission deadline for both eligible hospitals and eligible professionals to November 30, 2014. We believe that extending th e hardship exception ap plication deadline to November 30, 2014 will allow ample time for those el igible hospitals and eligible professionals that could not fully implement 2014 Edition CEHRT due to 2014 Edition CEHRT availability delays and that could not attest by their applicable attestati on deadline using the flexibility options provided in the 2014 CEHR T flexibility rule to file an application for the hardship exception recognized under this IFC. The extension of the hardship exception a pplication submission deadline to November 30, 2014, applies only to those providers who meet the criteria described under this IFC. We will not extend, reopen, or reconsider the hard ship exception application deadline for the 2015 payment adjustment for any other reason. Further, as explained above, because CAHs have still not reached their November 30, 2015 hardship exception application d eadline, they are not affected in the same manner as eligible hospitals and eligible professionals, and are still eligibleCMS-1612-FC 1079

to file a hardship exception application until November 30t h under any of the categories specified under §413.70(a)(6). Next, to extend the hardship exception a pplication deadline to November 30, 2014, for eligible hospitals and eligible professionals , we must amend under this IFC the July 1 st hardship exception application deadlin e for extreme and uncontrollable circumstances under §495.102(d)(4)(iii) for eligible pr ofessionals and the April 1 st deadline under §412.64(d)(4)(ii)(B) for eligible hos pitals. For eligible profe ssionals, the new amendment to §495.102(d)(4)(iii) will include, following the July 1 st hardship exception application submission deadline specified in the regulati on, language that would enable CMS to specify a later deadline. For eligible hospitals, the ne w amendment to §412.64( d)(4)(ii)(B) will in clude, following the April 1 st hardship exception application submission d eadline specified in th e regulation, language that would enable CMS to specify a later deadli ne. We are making these regulatory amendments under this IFC to allow eligible hospitals and eligible professiona ls to take advantage of the extreme and uncontrollable circumstances hardship exception outlined under this IFC. Without such changes, eligible hospitals and eligible professionals would be unable to apply for this hardship exception because the application deadlines have al ready passed. Finally, we note that, as with the circumstances described in this IF C that caused us to

extend the deadline to November 30, 2014, there may be situations in the future that would warrant extending the July 1 st deadline for eligible professionals, the April 1 st deadline for eligible hospitals, and the November 30 th deadline for CAHs. Accord ingly, to ensure that we do not face similar timing constraints in the future and to reduce administrative burden on providers who wish to request a hardship exception, we are amending the regulati on text for the other hardship exception categories to enable CMS to specify a later deadline for submission of hardship exception applications.CMS-1612-FC 1080

Specifically, for eligible professionals, in a ddition to the amendments we cited above for §495.102(d)(4)(iii) relating to the extreme and uncontrollable circ umstances hardship exception category, we are also amending §495.102(d)(4)(i) (ins ufficient internet ac cess) and (d)(4)(iv) (multiple locations/lack of f ace-to-face encounters and need for follow-up/certain primary specialties) to add similar language. For eligible hospitals, in addition to the amendments we cited above for §412.64(d)(4)(ii)(B) relating to the extreme and uncontrollable circum stances hardship exception category, we are also amending §412.64(d)(4)(ii)(A) (lac k of internet acce ss) to add similar language. For CAHs, we are amending §413.70(a)(6)(ii) to add language similar to the language added to the regulation text for eligible professi onals and eligible hospita ls, as discussed above. We believe that the flexibility to specify a later hardship exception application submission deadline as set forth above will prevent situati ons such as the one addressed under this IFC where, for example, an unforeseen circumstan ce occurred, which coul d justify a hardship exception, but the hardship excep tion application submission dead line has passed. However, we emphasize that we do not intend to exercise this flexibility to extend the hardship exception application submission deadline freq uently. Rather, to maintain the consistency needed for our operations, providers should expect to adhere to the dates spec ified in the regula tion text and not rely on the possibility of changes to the hardship application submission period occurring on a frequent basis.CMS-1612-FC 1081

IV. 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. To fairly

evaluate whether an information collection s hould be approved by OMB, section 3506(c)(2)(A) of the Paperwork Reduction Act of 1995 require s 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. Unless noted otherwise, we used data from the U.S. Bureau of Labor Statistics for all salary estimates. The estimates include the cost of fringe benefits, calc ulated at 35 percent of salary, which is based on the Bureau’s June 2012 Employer Costs for Employee Compensation report. In the CY 2015 PFS proposed rule (79 FR 40317), we solicited public comment on each of the section 3506(c)(2)(A)-required issues for the following information collection requirements (ICRs). A. Information Collection Requirements (ICRs) 1. ICRs Regarding the Removal of Employment Requirements for Services Furnished Incident to Rural Health Clinics and Federally Qualified Health Center VisitsCMS-1612-FC 1082

This provision removes the requirement that nonphysician RHC or FQHC practitioners be W-2 employees. This action does not require the modificati on of existing contracts or the creation of new contracts, nor does CMS collect any information on contracting. Consequently, the provision is not subject to the requirements under the Pa perwork Reduction Act of 1995 (44 U.S.C. 3501 et seq.). 2. ICRs Regarding Access to Identifiable Da ta for the Center for Medicare and Medicaid

Models This provision concerns the evaluation of models tested under, section 1115A of the Act. Section 1115(A)(d)(3) of the Act provides that the Paperwork Reduction Act (44 U.S.C. 3501 et seq.) shall not apply to the testing, evaluation or expansion of models unde r section 1115A of the

Act. 3. ICRs Regarding Local Coverage Determinat ion Process for Clinical Diagnostic Laboratory Testing The proposed Clinical Diagnostic Laborat ory LCD Process will not be finalized. Consequently, the Paperwork Reduction Act of 1995 (44 U.S.C. 3501 et seq.) and the LCD process do not apply to this final rule. 4. ICRs Regarding the Solicitat ion of Comments on the Payment Policy for Substitute Physician Billing Arrangements The proposed rule solicited comment on substi tute billing arrangements and did not set out any new or revised collection of informati on requirements. Consequently, the Paperwork Reduction Act of 1995 (44 U.S.C. 3 501 et seq.) is not applicable. 5. ICRs Regarding Reports of Payments or Ot her Transfers of Value and Physician Ownership and Investment Interests (§ 403.904(c)(8), (d)(3), and (g))CMS-1612-FC 1083

With regard to the following provisions, no PRA-related comments were received. The proposed provisions are bei ng adopted without change. In §403.904(c)(8), applicable manufactur ers and applicable group purchasing organizations (GPOs) must report the marketed name and therapeu tic area or product category of covered drugs, devices, biologi cals and medical supplies. Th e amendment has non-measurable

effect on current burden estimates since the ma nufacturers and GPOs are already required to report the marketed name for drugs and biologica ls and report the marketed name, therapeutic area, or product category for devices and medical supplies. While the requirement has no burden implications, the provision will be submitte d to OMB for approval under control number 0938- 1173 (CMS-10419). In §403.904(d)(3), applicable manufacturers and applicable GPOs must report the form of payment or other tran sfers of value as: cash or cash equi valent, in-kind items or services, stock, stock option, or any other ownership investment. The bu rden associated with this provision is the time and effort it will take each applicable manuf acturer and applicable GPO to revise their reporting system to report the form of payment. The removal of §403.904(g) requires that applicable manufactu rers and applicable GPOs of covered drugs, devices, biologicals, and me dical supplies report a nnually to CMS all payments or other transfers of value provide d as compensation for speaking at a continuing education program. The ongoing burden associated w ith this provision is the time and effort it will take each applicable manufacturer and applic able GPO to report payments or other transfers of value to CMS which were provided to physic ians at a continuing e ducation program. We estimate that it will take 1.0 hour to report paymen ts or other transfers of value to CMS which were provided to physician at a continuing education program.CMS-1612-FC 1084

We estimate that it will take 1.0 hour to repor t payments or other transfers of value to CMS which were provided to physician covered r ecipients as compensation for speaking at a continuing education program and 0.5 hours to revi se an applicable manuf acturer or applicable GPO’s reporting system to repor t the form of payment. In deriving these figures, we used the followi ng hourly labor rates and estimated the time to complete each task: $26.39/hr and 1.0 hours for support staff to report payments or other transfers of value to CMS which were provided to physician covered recipients as compensation for speaking at a continuing education program and $4+7.55/hr and 0.5 hours for support to revise their reporting system to report the form of payment. The preceding requirements and burden estima tes will be added to the existing PRArelated requirements and burden estimates th at have been approved by OMB under control number 0938-1173 (CMS-10419). 6. ICRs Regarding Physician Payment, Effi ciency, and Quality Improvements – Physician Quality Reporting System With regard to the following provisions, no PRA-related comments were received. The proposed provisions are bei ng adopted without change.

The annual burden estimate is calculated separately for the 2017 PQRS payment adjustment (the reporting periods of which occur in 2015): (1) i ndividual eligible professionals and group practices using the claims (for eligible professionals only), (2) qualified registry and QCDR, (3) EHR-based reporting mechanisms, and (4) group practices us ing the group practice reporting option (GPRO). Please note that we are grouping group practic es using the qualified registry and EHR-based reporting mechanisms with the burden estimate for individual eligible professionals using the qualified registry a nd EHR-based reporting mechanisms because we believe the criteria for satisfactory reporti ng for group practices using these 2 reportingCMS-1612-FC 1085

mechanisms under the GPRO are similar to the satisfactory reporting cr iteria for eligible professionals using these reporting mechanisms. a. Burden Estimate for PQRS Reporting by Indivi dual Eligible Profession als: Reporting in

General According to the 2012 Reporting Experience, “more than 1.2 million eligible professionals were eligible to participate in the 2012 PQRS, Medicare Shared Savings Program,

and Pioneer ACO Model.” 31 In this burden estimate, we assume that 1.2 million eligible professionals, the same number of eligible profes sionals eligible to participate in the PQRS in 2012, will be eligible to participat e in the PQRS. Historically, the PQRS has never experienced 100 percent participation in reporting for the PQ RS. Therefore, we believe that although 1.2 million eligible professionals will be subjec t to the 2017 PQRS payment adjustment, not all eligible participants will repor t quality measures data for pur poses of the 2017 PQRS payment adjustment. In this burden estimate, we will only provide burden estimates for the eligible professionals and group practices who attempt to submit quality measures data for purposes of the 2017 PQRS payment adjustment. In 2012, 435,871 eligible professionals (36 percen t of eligible prof essionals, including those who belonged to group practices that report ed under the GPRO and e ligible professionals within an ACO that participated in the PQRS via the Shared Savings Program or Pioneer ACO model) participated in the PQRS, Medicare Sh ared Savings Program, or Pioneer ACO Model. 32 We expect to see a significant increase in part icipation in reporting fo r the PQRS in 2015 than 2012 as eligible professionals were not subject to a PQRS payment adjustment in 2012. Last year, we estimated that we would see a 50 percen t participation rate in 2015. We still believe

31 Centers for Medicare and Medicaid Services, 2012 Reporting Experience Including Trends (2007—2013): Physician Quality Reporting System and Electronic Prescribing (eRx) Incentive Program , March 14, 2014, at xiii. 32 Id. at XV.CMS-1612-FC 1086

that a 14 percent increase in pa rticipation from 2012 is reason able in 2015. Therefore, we estimate that 50 percent of eligible prof essionals (or approximately 600,000 eligible professionals) will report quality measures data for purposes of the 2017 PQRS payment adjustment. With respect to the PQRS, the burden associated with the requirements of this voluntary reporting initiative is the time and effort associ ated with individual el igible professionals identifying applicable quality measures for wh ich they can report the necessary information, selecting a reporting option, and reporting the information on th eir selected measures or measures group to CMS using thei r selected reporting option.

We believe the labor associated with eligible professionals and group practices reporting quality measures data in the PQRS is primarily handled by an eligible professional’s or group practice’s billing clerk or computer analyst trained to report qualit y measures data. Therefore, we will consider the hourly wage of a billing clerk and computer analyst in our estimates. For purposes of this burden estimate, we assume th at a billing clerk will handle the administrative duties associated with participating in the PQ RS. According to information published by the Bureau of Labor Statistics, available at ht tp://www.bls.gov/oes/current/oes433021.htm, the mean hourly wage for a billing clerk is approxima tely $32.00/hour. Therefore, for purposes of handling administrative duties, we estimate an average labor cost of $32.00/hour. In addition, for purposes of this burden estimate, we assume that a computer analyst will engage in the duties associated with the reporting of quality measures. Accordi ng to information published by the Bureau of Labor Statistics, available at ht tp://www.bls.gov/oes/current/oes151121.htm, the mean hourly wage for a computer analyst is approxi mately $82.00/hour. Therefore, for purposes of reporting on quality measures, we estimate an average labor cost of $82.00/hour.CMS-1612-FC 1087

Please note that, in assessing PQRS-specific bu rden estimates, to account for benefits and

overhead associated with labor in addition to the hourly wage costs described above, we are doubling the wage rates in our estimates. While we accounted for fringe benefits in the NPRM’s wage estimates, we did not double th e wage rates in those estimates. For individual eligible professionals, the burden associated with the requirements of this reporting initiative is the time and effort associ ated with eligible professionals identifying applicable quality measures for which they can report the necessary information, collecting the necessary information, and reporting the information needed to re port the eligible professional’s

measures. We believe it is difficult to accurately quantify the burden because eligible professionals may have different processes for in tegrating the PQRS into their practice’s work flows. Moreover, the time needed for an eligible professional to review the quality measures and other information, select measures applicable to his or her patie nts and the services he or she furnishes to them, and incorporate the use of qual ity data codes into the office work flows is expected to vary along with the number of measures that are pot entially applicable to a given professional’s practice. Since elig ible professionals are generally required to report on at least 9 measures covering at least 3 National Quality St rategy domains criteria for satisfactory reporting (or, in lieu of satisfactory re porting, satisfactory participatio n in a QCDR) for the 2017 PQRS payment adjustment, we assume that each elig ible professional reports on an average of 9

measures for this bu rden analysis. For eligible professionals who are participating in PQRS for the first time, we will assign

5 total hours as the amount of time needed for an eligible professional’s billing clerk to review the PQRS measures list, review the various reporting options, select the most appropriate reporting option, identify the applicable measures or measures groups for which they can report the necessary information, review the measure specifications for the selected measures orCMS-1612-FC 1088

measures groups, and incorporate reporting of the se lected measures or measures groups into the

office work flows. The measures list contains the measure title and brief summary information for the eligible professional to review. Assuming the eligible professional has received no training from his/her specialty soci ety, we estimate it will take an eligible professional’s billing clerk up to 2 hours to review this list, review the reporting opti ons, and select a reporting option and measures on which to report. If an eligib le professional has rece ived training, then we

believe this would take less time. CMS believe s 3 hours is plenty of time for an eligible professional to review the measure specifications of 9 measures or 1 measures group they select to report for purposes of participating in PQRS and to develop a mechanism for incorporating reporting of the selected measures or measures gr oup into the office work flows. Therefore, we believe that the start-up cost for an eligible prof essional to report PQRS qua lity measures data is 5 hours x $32/hour = $160. We continue to expect the ongoing costs associ ated with PQRS participation to decline based on an eligible professional’s familiarity with and understanding of the PQRS, experience with participating in the PQRS, and increased efforts by CMS and stakeholders to disseminate

useful educational resources and best practices.

We believe the burden associated with reporting the quality measures will vary depending on the reporting mechanism selected by the eligible professional. As such, we break down the burden estimates by eligible profession als and group practices participating in the GPRO according to the reporting mechanism used. b. Burden Estimate for PQRS Reporting by I ndividual Eligible Prof essionals and Group Practices: Claims-Based Reporting Mechanism According to the 2011 PQRS and eRx Experience Report, in 2011, 229,282 of the 320,422 eligible professionals (or 72 percent) of eligible professionals used the claims-basedCMS-1612-FC 1089

reporting mechanism. According to th e 2012 Reporting Experience, 248,206 eligible professionals participated in the PQRS usi ng the claims-based reporting mechanism in 2012. 33 Preliminary estimates show that 252,567 eligible professionals pa rticipated in the PQRS using the claims-based reporting mechanism in 2013. 34 According to the historical data cited above , while the claims-based reporting mechanism is still the most widely-used reporting mechanism, we are seeing a decline in the use of the claims-based reporting mechanism in the PQRS. Wh ile these eligible professionals continue to participate in the PQRS, these eligible professional s have started to shift towards the use of other reporting mechanisms – mainly the GPRO web inte rface (whether used by a PQRS GPRO or an ACO participating in the PQRS via the Medicare Shared Savings Program or the Pioneer ACO Model), registry, or the EHR-ba sed reporting mechanisms. For purposes of this burden estimate, based on PQRS participation using the claims -based reporting mechanism in 2012 and 2013, we assume that approximately 250,000 eligible professi onals will participate in the PQRS using the claims-based reporting mechanism. For the claims based reporting option, eligible professionals must gather the required information, select the appropriate quality data codes (QDCs), and incl ude the appropriate QDCs on the claims they submit for payment. The PQ RS will collect QDCs as additional (optional) line items on the existing HIPAA transaction 837 P and/or CMS form CMS-1500 (OMB control number 0938-0999). We do not anticipate any ne w forms and or any modifications to the existing transaction or form. We also do not anticipate changes to the 837 P or CMS-1500 for

CY 2015.

33 Id . at xvi. See Figure 4. 34 Id

.CMS-1612-FC 1090

We estimate the cost for an eligible professi onal to review the list of quality measures or measures groups, identify the applicable measures or measures groups for which they can report the necessary information, incorporate reporting of the selected measures into the office work flows, and select a PQRS reporting option to be approximately $410 per eligible professional ($82 per hour x 5 hours). Based on our experience with the Physicia n Voluntary Reporting Program (PVRP), we

continue to estimate that the time needed to perform all the steps necessary to report each measure (that is, reporting the relevant quality da ta code(s) for 9 measures measure) would range from 15 seconds (0.25 minutes) to over 12 minutes for complicated cases and/or measures, with the median time being 1.75 minutes. To report 9 measures, we estimate that it will take approximately 2.25 minutes to 108 minutes to perfo rm all of the necessary reporting steps. Per measure, at an average labor cost of $82/ hour per practice, the cost associated with this burden will range from $0.34 to about $16.40 fo r more complicated cases and/or measures, with the cost for the median pr actice being $2.40. To report 9 m easures, using an average labor cost of $82/hour, we estimated that the cost of reporting for an eligible professional via claims will range from $3.07 (2.25 minutes or 0.0375 hours x $82/hour) to $147.60 (108 minutes or 1.8 hours x $82/hour) per reported case.

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 ea ch of the PQRS measures was 9. Since we reduced the required reporting rate by over one third to 50 percent, then for purposes of this burden analysis we assume that an eligible professional or eligible professional in a group practice will need to report each selected m easure for 6 reporting instances. The actual numberCMS-1612-FC 1091

of cases on which an eligible professional or gro up practice is required to report quality measures data will vary, however, with the eligible prof essional's or group pract ice’s patient population and the types of measures on which the eligible professional or group prac tice chooses to report (each measure's specifications includes a required reporting frequency). Based on these assumptions, we estimate th at the total annual reporting burden per individual eligible professiona l associated with claims ba sed reporting will range from 13.5 minutes (0.25 minutes per measure x 9 measures x 6 cases per measure) to 648 minutes (12 minutes per measure x 9 measures x 6 cases per m easure), with the burden to the median practice being 94.5 minutes (1.75 minutes per measure x 9 m easures x 6 cases). We estimate the total annual reporting cost per eligible professional or eligible professi onal in a group practice associated with claims based reporting will ra nge from $18.36 ($0.34 per measure x 9 measures x 6 cases per measure) to $885.60 ($16.40 per measure x 9 measures x 6 cases per measure), with the cost to the median practice being $129.6 0 per eligible professi onal ($2.40 per measure x 9 measures x 6 cases per measure). c. Burden Estimate for PQRS Reporting by I ndividual Eligible Prof essionals and Group Practices: Qualified Registry-based and QCDR-based Reporting Mechanisms In 2011, approximately 50,215 (or 16 percen t) of the 320,422 eligib le professionals participating in PQRS used the qualified registry -based reporting mechanism. According to the 2012 Reporting Experience, 36,473 eligible professi onals reported individual measures via the registry-based reporting mechan ism, and 10,478 eligible professi onals reporting measures groups via the registry-based reporting mechanism in 2012. 35 Therefore, approximately 47,000 eligible professionals participated in the PQRS using the registry-based reporting mechanism in 2012.

35 Id . at xvi. See Figure 4.CMS-1612-FC 1092

Please note that we currently have no data on participation in the PQRS via a QCDR as 2014 is the first year in which an eligible professional may participate in the PQRS via a QCDR. We believe that the rest of the eligible pr ofessionals not participating in other PQRS reporting mechanisms will use either the regi stry or QCDR reporting mechanisms for the following reasons:

● The PQRS measures set is moving away from use of claims-based measures and moving towards the use of registry-based measures.

● We believe the number of QCDR vendor s will increase as the QCDR reporting

mechanism evolves. Therefore, based on these assumptions, we e xpect to see a significant jump from 47,000 eligible professionals to appr oximately 165,000 eligible professiona ls using either the registrybased reporting mechanism or QCDR in 2015. We believe the majority of these eligible professionals will participate in the PQRS usi ng a QCDR, as we presume QCDRs will be larger

entities with more members. For qualified registry based and QCDR-based reporting, there will be no additional time burden for eligible professionals or group practices to report da ta to a qualified registry as eligible professionals and group pr actices opting for qualified regist ry based reporting or use of a QCDR will more than likely already be reporting da ta to the qualified registry for other purposes and the qualified registry will merely be repackagi ng the data for use in the PQRS. Little, if any, additional data will need to be reported to the qu alified registry or QCDR solely for purposes of participation in the PQRS. However, eligible professionals and group pr actices will need to authorize or instruct the qualified registry or QCDR to submit quality measures results and numerator and denominator data on quality measures to CMS on their behalf. We estimate thatCMS-1612-FC 1093

the time and effort associated with this will be approximately 5 minutes per eligible professional or eligible professional within a group practice. Please note that, unlike the claims-based reporting mechanism that would require an eligible professional to report data to CMS on quality measures on multiple occasions, an eligible professional would not be required to submit this data to CMS, as the qualified registry or QCDR would perform this function on the eligible professional’s behalf. d. Burden Estimate for PQRS Reporting by I ndividual Eligible Prof essionals and Group Practices: EHR-Based Reporting Mechanism According to the 2011 PQRS and eRx Experi ence Report, in 2011, 560 (or less than 1 percent) of the 320,422 eligible professionals participating in PQRS used the EHR-based reporting mechanism. In 2012 there was a shar p increase in reporting via the EHR-based reporting mechanism. Specifically, according to the 2012 Reporting Experience, in 2012, 19,817 eligible professionals submitted quality da ta for the PQRS through a qualified EHR. 36 We believe the number of eligible professi onals and group practices using the EHR-based reporting mechanism will steadily increase as eligib le professionals become more familiar with EHR products and more eligible professionals part icipate in programs encouraging the use of an EHR, such as the EHR Incentive Program. In part icular, we believe eligible professionals will transition from using the claims-based to the EH R-based reporting mechanism. To account for this anticipated increase, we continue to estimate that approximately 50,000 eligible professionals, whether participating as an indivi dual or part of a group practice under the GPRO, would use the EHR-based reporting mechanism in CY 2015.

36 Id . at xv.CMS-1612-FC 1094

For EHR-based reporting, which includes EHR reporting via a direct EHR product and an EHR data submission vendor’s prod uct, the eligible professional or group practice must review the quality measures on which we will be accepting PQRS data extracted from EHRs, select the appropriate quality measures, extract the necessary clinical data from his or her EHR, and submit the necessary data to the CMS-design ated clinical data warehouse. For EHR based reporting for the PQRS, the i ndividual eligible prof essional or group practice may either submit the quality measures da ta directly to CMS from their EHR or utilize

an EHR data submission vendor to submit the da ta to CMS on the eligible professional’s or group practice’s behalf. To submit data to CM S directly from thei r EHR, the eligible professional or eligible professional in a gr oup practice must have access to a CMS specified identity management system, such as IACS, whic h we believe takes less than 1 hour to obtain. Once an eligible professional or eligible profe ssional in a group practice has an account for this CMS specified identity management system, he or she will need to extract the necessary clinical data from his or her EHR, and submit the necessa ry data to the CMS designated clinical data warehouse. With respect to submitting the actual data file for the respective reporting period, we

believe that this will take an eligible professional or group practice no more than 2 hours, depending on the number of patients on which th e eligible professiona l or group practice is submitting. We believe that once the EHR is programmed by the vendor to allow data submission to CMS, the burden to the eligible professional or group practice associated with submission of data on quality measures should be minimal as all of the information required to report the measure should already reside in the e ligible professional's or group practice’s EHR. e. Burden Estimate for PQRS Reporting by Gr oup Practices Using the GPRO Web Interface As we noted in last year’s estimate, according to the 2011 Experience Report, approximately 200 group practices participated in the GPRO in 2011. According to the 2012CMS-1612-FC 1095

Reporting Experience, 66 practices participated in the PQRS GPRO. 37 In addition, 144 ACOs participated in the PQRS GPRO through either the Medicare Shared Savings Program (112 ACOs) or Pioneer ACO Model (32 practices). 38 These group practices encompass 134,510 eligible professionals (or approxi mately 140,000 eligible professionals). 39 Since it seems that roughly 200 group practices participated in the GPRO in 2011 and 2012, based on these numbers, we assume that 200 group practices (accounting for approxi mately 135,000 eligible professionals) will participat e in the PQRS using the GP RO web interface in 2015. With respect to the process for group practices to be treated as satisfactorily submitting quality measures data under the PQRS, group practic es interested in participating in the PQRS through the GPRO must complete a self-nomina tion process similar to the self-nomination process required of qualified re gistries. However, since a gr oup practice using the GPRO web

interface would not need to determine which measur es to report under PQRS, we believe that the self-nomination process is handled by a group prac tice’s administrative staff. Therefore, we estimate that the self-nomination process fo r the group practices for the PQRS involves approximately 2 hours per group practice to review the PQRS GPRO and make the decision to participate as a group rather than individually and an additional 2 hours per group practice to draft the letter of intent for self-nomination, ga ther the requested TIN and NPI information, and provide this requested information. It is estimat ed that each self-nomin ated entity will also spend 2 hours undergoing the vetting process with CMS officials. We assume that the group practice staff involved in the group practice sel f-nomination process ha s an average practice labor cost of $32 per hour. Therefore, a ssuming the total burden hours per group practice associated with the group practice self-nominati on process is 6 hours, we estimate the total cost

37 Id . at xv. 38 Id . at xvi. 39 Id . at 18.CMS-1612-FC 1096

to a group practice associated with the gr oup practice self-nomination process to be approximately $192 ($32 per hour x 6 hours per group practice). The burden associated with the group practi ce reporting requirements under the GPRO is the time and effort associated with the group pr actice submitting the quality measures data. For physician group practices, this would be the time associated with the physician group completing

the web interface. We estimate that the time an d effort associated with using the GPRO web interface will be comparable to the time and effort associated to using the PAT. As stated above, the information collection components of the PAT have been reviewed by OMB and are approved under control number 0938-0941(form CMS- 10136) with an expirati on date of July 31, 2015, for use in the PGP, MCMP, and EHR demons trations. As the GPRO was only recently implemented in 2010, it is difficult to determine th e time and effort associated with the group practice submitting the quality measures data. As such, we will use the same burden estimate for group practices participati ng in the GPRO as we use for group practices participating in the PGP, MCMP, and EHR demonstrations. Since thes e changes will not have any impact on the information collection requirements associated with the PAT and we will be using the same data submission process used in the PGP demonstration, we estimate that the bur den associated with a group practice completing data for PQRS under the web interface will be the same as for the group practice to complete the PAT for the PGP demonstration. In other words, we estimate that, on average, it will take each group practice 79 hours to submit quality measures data via the GPRO web interface at a cost of $82 per hour. Th erefore, the total estimated annual cost per group practice is estimated to be approximately $6,478. 7. ICRs Regarding the Medica re Shared Savings ProgramCMS-1612-FC 1097

Section 3022 of the Affordable Care Ac t exempts any collection of information associated with the Medicare Shared Savings Pr ogram from the requirements of the Paperwork Reduction Act of 1995 (44 U.S.C. 3501 et seq.). 8. ICRs Regarding Interim Revisions to the Elec tronic Health Record (EHR) Incentive Program This rule does not impose new or alter ex isting reporting, recordk eeping, or third-party disclosure requirements. Consequently, it need not be reviewed by OMB under the authority of the Paperwork Reduction Act of 1995 (44 U.S.C. 3501 et seq.). 9. ICRs Regarding the Extreme and Uncont rollable Circumstances Hardship Exception With regard to the hardship application, th is rule will not impose any new or revised reporting, recordkeeping, or third-party disclosu re requirements and ther efore, does not require

additional OMB review under the authority of the Paperwork Re duction Act of 1995 (44 U.S.C. 3501 et seq.). The application’s information collection requirements and burden have been approved by OMB under OMB control number 0938-1158 (CMS-10336). B. Summary of Final Burden Estimates

Table 92 summarizes this rule’s requirements and burden estimates.CMS-1612-FC 1098

TABLE 92: Annual Recordkeeping and Reporting Requirements and Burden

Regulation Section(s) OMB & CMS ID #s Respondents Responses (total) Burden (time) per Response Total Annual Burden (hours) Labor Cost of Reporting ($/hr) Total Cost ($) 403.904(d)(3) 0938- 1173(CMS10419 1,150 (manufacturers) 1,150 1.0 hr (reporting) 1,150 26.39 30,349

0.5 hr (system upgrades) 575 47.55 27,341

420 (GPOs) 420 1.0 hr (reporting) 420 26.39 11,084

0.5 hr (system upgrades) 210 47.55 9,986

CY 2015 PQRS (start up for first time participants) 0938- 1059(CMS10276) 164,000 164,000 5 hr 820,000 16.00 13,120,000

CY 2015 PQRS(ClaimsBased Reporting Mechanism) 0938- 1059(CMS10276) 250,000 250,000 (preparation and reporting) 5.2241 1,306,025 82.00 107,090,000

CY 2015 PQRS (QualifiedRegistrybased and QCDR-based Reporting Mechanisms) 0938- 1059(CMS10276) 165,000 165,000 5 min 13,750 N/A* N/A

CY 2015PQRS (EHRBased Reporting Mechanism) 0938- 1059(CMS10276) 50,000 50,000 N/A** N/A N/A N/A

CY 2015 PQRS (Group Practices Using the GPRO Web Interface) 0938- 1059(CMS10276) 200 200 (selfnomination

process) 6 hr 17,000 192.00 1,334,000

200 (reporting) 79 hr

TOTAL 630,770 14,130,970 -- 2,159,130 -- 121,622,760 *There is no set cost. As explained above, the cost will vary depending on the registry used. Additionally, many EPs and group practices using a registry or QCDR will mo st likely use a registry or QCDR for other purposes. **As explained above, the burden associated with the submission of data is minimal. C. Submission of PRA-Related CommentsCMS-1612-FC 1099

We have submitted a copy of this rule to OMB for its review of the rule’s information collection and recordkeeping requirements. These requirements are not effective until they have been approved by OMB. To obtain copies of the supporting statemen t and any related forms for the paperwork collections referenced above, access CMS’ website at http://www.cms.hhs.gov/PaperworkReductionAct of1995; email your request, including your address, phone number, OMB number, and CMS document identifier, to Paperwork@cms.hhs.gov; or call the Reports Clearance Office at 410–786–1326. When commenting on the stated information collections, please reference the document

identifier or OMB control number. To be assured consideration, comments and recommendations must be received by the OM B desk officer via one of the following

transmissions:

Mail: OMB, Office of Information and Regulatory Affairs

Attention: CMS Desk Officer

Fax: (202) 395-5806 OR

E-mail: OIRA_submission@omb.eop.gov

. PRA-specific comments must be received by December 1, 2014 [

. V. 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 thisCMS-1612-FC 1100

preamble, and, when we proceed with a subse quent document, we will respond to the comments in the preamble to that document.CMS-1612-FC 1101

VI. Waiver of Proposed Rulemaking and Waiver of Delay in Effective Date A. PFS provisions We ordinarily publish a notice of proposed rulemaking in the Federal Register and invite public comment on the proposed rule. The notice of proposed rulemaking includes a

reference to the legal authority under which the rule is proposed, and the terms and substance of the proposed rule or a description of the subject s and issues involved. This procedure can be waived, however, if an agency finds good cause that a notice-and-comment procedure is impracticable, unnecessary, or contrary to the public interest and incorporat es a statement of the finding and its reasons in the rule issued. We utilize HCPCS codes for Medicare payment purposes. The HCPCS is a national coding system comprised of Level I (CPT) codes and Level II (HCPCS National Codes) that are intended to provide uniformity to coding proced ures, services, and supplies across all types of medical providers and suppliers. Level I (CPT) codes are copyrighted by the AMA and consist of several categories, including Category I codes which are 5-digit numeric codes, and Category III codes which are temporary codes to track em erging technology, services, and procedures. The AMA issues an annual update of the CPT code set each Fall, with January 1 as the effective date for implementing the updated CPT codes. Th e HCPCS, including both Level I and Level II codes, is similarly updated annually on a CY basi s. Annual coding changes are not available to the public until the Fall immediately preceding th e annual January update of the PFS. Because of the timing of the release of th ese new and revised codes, it is impracticable for us to provide prior notice and solicit comment on these codes a nd the RVUs assigned to them in advance of publication of the final rule that implements th e PFS. Yet, it is imperative that these coding changes be accounted for and recognized timely under the PFS for payment because services represented by these codes will be furnished to Medicare beneficiaries by physicians andCMS-1612-FC 1102

practitioners during th e CY in which they become eff ective. Moreover, regulations implementing HIPAA (42 CFR parts 160 and 162) re quire that the HCPCS be used to report health care services, including se rvices paid under the PFS. We assign interim RVUs to any new

and revised codes based on a review of the RUC recommendations for valuing these services. We also assign interim RVUs to certain code s for which we did not receive specific RUC recommendations, but that are components of new combined codes. We set interim RVUs for the component codes in order to conform them to the value of the combined code. Finally, we assign interim RVUs to certain codes for whic h we received RUC recomm endations for only one component (work or PE) but not both. By re viewing these RUC recommendations for the new and revised codes, we are able to assign RVUs to services based on input from the medical community and to establish payment for them, on an interim basis, that corresponds to the relative resources associated with furnishing the se rvices. We are also able to determine, on an interim final basis, whether the codes will be subj ect to other payment policies. If we did not assign RVUs to new and revised codes on an interim basis, the alternative would be to either not pay for these services during the initial CY or have each Medicare contractor establish a payment

rate for these new codes. We believe both of thes e alternatives are contrary to the public interest, particularly since the RUC process allows for an assessment of the valuation of these services by the medical community prior to our establishing payment for these codes on an interim basis. Therefore, we believe it would be contrary to the public interest to delay establishment of fee schedule payment amounts for these codes unt il notice and comment procedures could be completed. This final rule with comment period revises the process we will use to address new,

revised in order to minimize the need to establ ish RVUs on an interim fi nal basis beginning with rulemaking for CY 2017. However, for the reasons previously outlined in this section, we findCMS-1612-FC 1103

good cause to waive the notice of proposed ru lemaking for the interim RVUs for selected procedure codes identified in Addendum C and to establish RVUs for these codes on an interim final basis for CY 2015. We are prov iding a 60-day public comment period.

Section II.E. of this final ru le with comment period discu sses our review and decisions regarding the RUC recommendations. Similar to the RUC recommendations for new and revised codes previously discussed, due to the timing of the RUC recommendations for the services identified as potentially misvalued codes, it is impracticable for CMS to provide for notice and comment regarding specific revision s prior to publication of this final rule with comment period. We believe it is in the public interest to im plement the revised RVUs for the codes that were identified as misvalued, and that have been review ed and re-evaluated by the RUC, on an interim

final basis for CY 2015. The revised RVUs for these codes will establish a more appropriate payment that better corresponds to the relative resources involved in furnishing these services. A delay in implementing revised va lues for these misvalued codes would not only perpetuate the

known misvaluation for these servic es, it would also perpetuate distortion in the payment for other services under the PFS. Implementing th e changes on an interim basis allows for a more equitable resource-based distribution of payments across all PFS services. We believe a delay in implementation of these revisions would be contrary to the public interest, particularly since the RUC process allows for an assessment of the valuation of these services by the medical community prior to the RUC’s recommendation to CMS. This final rule with comment period revises the process we will use to address misvalued codes in order to minimize the need to establish RVUs on an interim final basis beginn ing with rulemaking for CY 2017. However, for the reasons previously described, we find good cau se to waive notice and comment procedures with respect to the misvalued codes and to revise RVUs for these codes on an interim final basis for CY 2015. We are providing a 60-day public comment period.CMS-1612-FC 1104

B. FQHC PPS Rates and Adjustments We ordinarily publish a notice of proposed ru lemaking in the Federal Register and invite public comment on the proposed rule before publis hing a final rule that responds to comments and sets forth final regulations th at generally take effect at leas t 30 days later. This procedure can be waived, however, if an agency finds good cause that a notice-and-comment procedure is impracticable, unnecessary, or contrary to the public interest and incorporat es a statement of the finding and its reasons in the rule issued. In the May 2, 2014, interim final rule (79 FR 25462), we updated §405.2411(b)(2) so that it reflects section 1888(e)(2)(A)(iv) of the Act (as amended by section 410 of the MMA), which excludes certain RHC and FQHC prac titioner services from consolidat ed billing and allows such services to be separately billable under Part B when furnished to a resident of a SNF during a covered Part A stay. However, in making this revision, we ina dvertently neglected to make a conforming change in §411.15(p)(2), which e numerates the individua l services that are excluded from the SNF consolidated billing provision, as well as in §489.20(s), which specifies compliance with consolidated billing as a require ment of the SNF’s Medicare pr ovider agreement. Accordingly, we are now rectifying that omission in this final rule with comme nt period, by making a conforming technical revisi on in §411.15(p)(2) and §489.20(s). These particular revisions merely provide technical corrections to the regulations, without making any substantive changes. Th erefore, for good cause, we waive notice and comment procedures for the revisions to the regulations text in parts 411 and 489.

C. Interim Final Revisions to the Electronic He alth Record (EHR) Incentive Program We ordinarily publish a notice of proposed rulemaking in the Federal Register and invite public comment on the proposed rule. The notice of proposed rulemaking includes aCMS-1612-FC 1105

reference to the legal authority under which the rule is proposed, and the terms and substance of the proposed rule or a description of the subject s and issues involved. This procedure can be waived, however, if an agency finds good cause that a notice-and-comment procedure is impracticable, unnecessary, or contrary to the public interest and incorporat es a statement of the finding and its reasons in the rule issued. With regard to the interim revisions to the Electronic H ealth Record (EHR) Incentive Program, we find good cause to waive th e notice-and-comment pr ocedure as contrary to the public interest. We believe that provi ding notice and a comment period would prevent us from providing relief from the circumstances outlin ed in section III.Q. A delay would interfere with the ability of eligible professionals and elig ible hospitals to request a hardship exception for the extreme and uncontrollable circumstances speci fied under this IFC given that the hardship applications deadlines have since passed for both eligible professionals and eligible hospitals. Any delay to this IFC would potentially subjec t providers to the 2015 payment adjustment under the Medicare EHR Incentive Program and potentia lly decrease participation in the EHR Incentive Programs, thereby creating a negative impact to the forward movement of the EHR Incentive Programs. For these reasons, we find good cause to waive the notice of proposed rulemaking for these revisions to the EHR Incenti ve Program and to establish these revisions on an interim final basis. We are prov iding a 60-day public comment period. We ordinarily provide a 60-day delay in the effective date of final rules after the date they are issued. The 60-day dela y in effective date can be waived, however, if the agency finds for good cause that the delay is impracticable, unn ecessary, or contrary to the public interest, and the agency incorporates a statement of the findi ngs and its reasons in the rule issued. The delayed effective date may also be waived in the case of a substantive rule which grants or recognizes an exemption or relieves a restriction. For the reasons set forth below, we believe itCMS-1612-FC 1106

would be contrary to the public inte rest to delay the effective date of the interim final revisions to the EHR Incentive Program described in section III.Q of this final rule with comment period We

also believe these interim final revi sions relieve a restriction . The IFC recognizes a hardship excepti on based on extreme and uncontrollable circumstances, which could potentially provide relief from the application of the 2015 payment adjustment under the Medicare EHR Incentive Progr am to certain providers. This IFC would

also relieve a restricti on by amending the existing deadlines in the regulation text for providers to apply for hardship exceptions from the payment adjustments. Unless these amendments to the deadlines are made effective immediately, eligible hospitals and eligible professionals would not have enough time to take advantage of the November 30 th extended hardship exception application submission period specified in this IFC, given that their hardship exception application submission deadlines have since pa ssed. We find good cause to waive the delayed

effective date of the interim final revisions to the EHR Incentive Program and find that they relieve an existing restricti on by changing the deadlines by which providers must apply for hardship exceptions. These provisions will be e ffective on [OFR—Insert date of filing for public inspection at OFR].CMS-1612-FC 1107

VI. Regulatory Impact Analysis

A. Statement of Need This final rule with comment period is necessary to make payment and policy changes under the Medicare PFS and to make required statutory changes under the Pathway for SGR

Reform Act of 2013 and the PAMA. This final ru le with comment period also is necessary to make changes to Part B payment policy for clinical diagnostic lab tests an d other Part B related policies. This rule also implements aspect s of the data collecti on required under section 1115A(b)(4) of the Act. 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, 2013), 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 final rule with comment period will redistribute mo re than $100 million in 1 year. Therefore, we estimate that this rulemaking is "economically significant" as measured by the $100 millionCMS-1612-FC 1108

threshold, and hence also a major rule under the Congressional Review Act. Accordingly, we have prepared a RIA that, to the best of our ability, presents the costs and benefits of the rulemaking. The RFA requires agencies to analyze options for regulatory relief of small entities. For purposes of the RFA, small entities incl ude small businesses, nonprofit organizations, and small governmental jurisdictions. Most hospitals , practitioners and most other providers and suppliers are small entities, either by nonprofit st atus or by having annual revenues that qualify

for small business status under the Small Business Ad ministration standards. (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 St ates are not included in the de finition 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. Approximately 95 percent of practitioners, othe r providers and suppliers are considered to be small entities, based upon the SBA standards. There are over 1 million physicians, other practitioners, and medical suppliers that recei ve Medicare payment under the PFS. Because many of the affected entities are small entities, the analysis an d discussion provided in this

section as well as elsewhere in this final rule with comment period is in tended to comply with the RFA requirements. In addition, section 1102(b) of th e Act requires us to prepare an RIA if a rule may have a significant impact on the operations of a substantial number of small rural hospitals. ThisCMS-1612-FC 1109

analysis must conform to the provisions of s ection 604 of the RFA. For purposes of section 1102(b) of the Act, we define a small rural hosp ital as a hospital that is located outside of a Metropolitan Statistical Area for Medicare payment regulations a nd has fewer than 100 beds. We are not preparing an analysis for section 1102( b) of the Act because we have determined, and the Secretary certifies, that this final rule wi th comment period 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 2014, that threshold is approximately $141 million. This final rule with comment period would im pose no mandates on state, local, or tribal governments or on the private sector. Executive Order 13132 establishes certain requirem ents that an agency must meet when it promulgates a proposed rule (and subsequent fi nal rule) that imposes substantial direct requirement costs on State and local governme nts, preempts State law, or otherwise has Federalism implications. Since this regulati on does not impose any costs on State or local governments, the requirements of Ex ecutive Order 13132 are not applicable. We have prepared the following analysis, whic h together with the information provided in the rest of this preamble, meets all assessm ent requirements. The analysis explains the rationale for and purposes of this final rule with comment period; details the costs and benefits of the rule; analyzes alternatives; and presents th e measures we would use to minimize the burden

on small entities. As indicated elsewhere in this final rule with comment period, we are implementing a variety of changes to our regula tions, payments, or payment policies to ensureCMS-1612-FC 1110

that our payment systems reflect changes in medi cal practice and the relative value of services, and to implement statutory provisions. We provide information for each of the policy changes in

the relevant sections of this final rule with comment period. We are unaware of any relevant federal rules that duplicate, overl ap, or conflict with this final rule with comment period. The

relevant sections of this final rule with co mment period contain a desc ription 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 budget neutrality. Our estimates of changes in Medicare reve nues for PFS services compare payment rates for CY 2014 with payment rates for CY 2015 usi ng CY 2013 Medicare utilization as the basis for the comparison. The payment impacts reflect averages for each specialty based on Medicare utilization. The payment impact for an indi vidual physician could vary from the average and would depend on the mix of services the physicia n furnishes. The average change in total revenues would be less than the impact displaye d here because physicians furnish services to both Medicare and non-Medicare patients and sp ecialties may receive substantial Medicare revenues for services that are not paid under th e PFS. For instance, independent laboratories receive approximately 83 percent of their Medicare revenues from clinical laboratory services that are not paid under the PFS. We note that these impacts do not include th e effect of the Apr il 2015 conversion factorCMS-1612-FC 1111

changes under current law. The annual update to the PFS conversion factor is calculated based on a statutory formula that measur es actual versus allowed or “tar get” expenditures, and applies a sustainable growth rate (SGR ) calculation intended to control growth in aggregate 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 wit hheld if the percentage increase in actual expenditures exceeds the SGR. Rather, the PFS update, as specified in section 1848(d)(4) of the Act, is adjusted to eventually bring actual expenditu res back in line with targets. If actual expenditures exceed allowed expenditures, the update is reduced. If actual expenditures are less than allowed expenditures, the update is increased. By la w, we are required to apply these updates in accordance with sections 1848(d) and (f) of the Act, and any negative updates can only be averted by an Act of the Congress. Although th e Congress has provided temporary relief from negative updates for every year since 2003, a long-term solution is critical. We are committed to working with the Congress to reform Medicar e physician payments to provide predictable payments that incentivize quality and efficiency in a fiscally responsible way. We provide our most recent estimate of the SGR and physic ian update for CY 2015 on our website athttp://www.cms.gov/Medicare/Medicare-Fee-for-ServicePayment/SustainableGRatesConFact/index.htm l?redirect=/SustainableGRatesConFact/

. Tables 93 shows the payment impact on PFS se rvices. To the extent that there are year-to-year changes in the volume and mix of services provided by physicians, the actual impact on total Medicare revenues will be diffe rent from those shown in Table 93 (CY 2015 PFS

Final Rule with Comment Period Estimated Impact on Total Allowed Charges by Specialty )

. The following is an explanation of the in formation represented in Table 93:CMS-1612-FC 1112

• 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 2013 utilization and CY 2014 rates. That is, allowed charges are

the PFS amounts for covered services and incl ude coinsurance and de ductibles (which are the financial responsibility of the benefici ary). These amounts have been summed across all services furnished by physicians, practiti oners, and suppliers within a specialty to

arrive at the total allowed charges for the specialty.

• Column C (Impact of Work RVU Changes): This column shows the estimated CY 2015 impact on total allowed charges of the cha nges in the work RVUs, including the impact of changes due to new, revised, and misvalued codes.

• Column D (Impact of PE RVU Changes): This column shows the estimated CY 2015 impact on total allowed charges of the change s in the PE RVUs, including the impact of changes due to new, revised, and misvalued codes, the film-to-digital migration of imaging inputs, and other miscellaneous and minor provisions.

• Column E (Impact of Malprac tice (MP) Changes): This column shows the estimated CY 2015 impact on total allowed charges of the changes in the MP RVUs, which are primarily driven by the required five year review and update of MP RVUs.

• Column F (Cumulative Impact): This colu mn shows the estimated CY 2015 combined impact on total allowed charges of all the changes in the previous columns. Column F may not equal the sum of column s C, D, and E due to rounding.CMS-1612-FC 1113

TABLE 93: CY 2015 PFS Final Rule with Co mment Period Estimated Impact Table: Impacts of Work, Practice Ex pense, and Malpractice RVUs

(A) Specialty (B)

Allowed Charges

(mil) (C) Impact of Work

RVU Changes (D) Impact of PE RVU Changes (E) Impact of MP RVU Changes (F) Combined

Impact

TOTAL $88,045 0% 0% 0% 0% ALLERGY/IMMUNOLOGY $216 0% 0% 0% 0% ANESTHESIOLOGY $1,993 0% 0% 0% 0% AUDIOLOGIST $60 0% 0% 0% 0% CARDIAC SURGERY $355 0% 0% -1% -1% CARDIOLOGY $6,470 0% 0% 0% 0% CHIROPRACTOR $812 0% 0% -1% -1% CLINICAL PSYCHOLOGIST $704 0% -1% 0% -1% CLINICAL SOCIAL WORKER $522 0% -1% 0% -1% COLON AND RECTAL SURGERY $159 0% 0% 0% 0% CRITICAL CARE $287 0% 0% 0% 0% DERMATOLOGY $3,177 0% -1% 0% -2% DIAGNOSTIC TESTING FACILITY $715 0% -2% 0% -2% EMERGENCY MEDICINE $3,046 0% 0% 1% 1% ENDOCRINOLOGY $457 0% 0% 0% 0% FAMILY PRACTICE $6,107 1% 1% 0% 1% GASTROENTEROLOGY $1,884 0% 0% 0% 0% GENERAL PRACTICE $506 0% 0% 0% 0% GENERAL SURGERY $2,245 0% 0% 0% 0% GERIATRICS $227 1% 1% 0% 1% HAND SURGERY $160 0% 0% 0% 0% HEMATOLOGY/ONCOLOGY $1,811 0% 1% 0% 1% INDEPENDENT LABORATORY $714 -1% 0% 0% -1% INFECTIOUS DISEASE $652 0% 0% 0% 1% INTERNAL MEDICINE $11,123 1% 1% 0% 1% INTERVENTIONAL PAIN MGMT $678 0% 1% 0% 0% INTERVENTIONAL RADIOLOGY $273 0% 1% 0% 0% MULTISPECIALTY CLINIC/OTHER PHY $84 0% 0% 0% 0% NEPHROLOGY $2,181 0% 0% 0% 0% NEUROLOGY $1,513 0% 0% 0% 0% NEUROSURGERY $740 0% 0% 1% 1% NUCLEAR MEDICINE $49 0% 0% 0% 0% NURSE ANES / ANES ASST $1,186 0% 0% 0% 0% NURSE PRACTITIONER $2,224 0% 0% 0% 1% OBSTETRICS/GYNECOLOGY $696 0% 0% 0% -1% OPHTHALMOLOGY $5,685 0% 0% -2% -2%CMS-1612-FC 1114

(A) Specialty (B)

Allowed Charges

(mil) (C) Impact of Work

RVU Changes (D) Impact of PE RVU Changes (E) Impact of MP RVU Changes (F) Combined

Impact

OPTOMETRY $1,163 0% 0% -1% -1% ORAL/MAXILLOFACIAL SURGERY $45 0% 0% 0% 0% ORTHOPEDIC SURGERY $3,672 0% 0% 0% -1% OTHER $28 0% 0% -1% -1% OTOLARNGOLOGY $1,174 0% 0% 0% 0% PATHOLOGY $1,077 -1% 1% 0% 0% PEDIATRICS $59 0% 0% 0% 0% PHYSICAL MEDICINE $1,008 0% 0% 0% 0% PHYSICAL/OCCUPATIONAL THERAPY $2,836 0% 0% 1% 1% PHYSICIAN ASSISTANT $1,565 0% 0% 0% 0% PLASTIC SURGERY $374 0% 0% -1% 0% PODIATRY $2,001 0% 0% 0% 0% PORTABLE X-RAY SUPPLIER $112 0% -2% 0% -2% PSYCHIATRY $1,352 0% 0% 0% 0% PULMONARY DISEASE $1,795 0% 0% 0% 0% RADIATION ONCOLOGY $1,794 0% 0% 0% 0% RADIATION THERAPY CENTERS $57 0% 0% 0% 1% RADIOLOGY $4,523 0% -1% 0% -1% RHEUMATOLOGY $541 0% 0% 0% -1% THORACIC SURGERY $343 0% 0% -1% -1% UROLOGY $1,838 0% 0% 0% 0% VASCULAR SURGERY $978 0% 0% 0% 0% Note: Table 93 shows only the payment impact on PFS services . These impacts use a constant conversion factor and thus do not include the effects of the April 2015 conversion factor change required under current law.

2. CY 2015 PFS Impact Discussion a. Work RVU Impacts The changes in work RVU impacts are almost entirely attributable to the payment for CCM services beginning in CY 2015. We finalized this separately billable CCM service in the CY 2014 final rule with comment period, eff ective beginning in CY 2015 (78 FR 74414 through 74427). We are finalizing a payment rate for CCM services for CY 2015 (see section II.G. of thisCMS-1612-FC 1115

final rule with comment period.) Payment for th is service is expected to result in modest payment increases for family practice, internal medicine , and geriatrics. b. PE RVU Impacts Payment for CCM services also has a positive impact on the PE RVUs attributable to family practice, internal medici ne, and geriatrics. The most wide spread specialty impacts in PE RVUs are generally related implementing the RU C recommendation regardi ng the film-to-digital migration of imaging inputs, whic h primarily affects portable x-ray suppliers, diagnostic testing facilities, and interventional ra diology. Other impacts result fro m adjustments of PE RVUs for

services as discussed in section II.A. of this final rule with comment period. c. MP RVU Impacts The changes in MP RVUs are primarily attribut able to the changes made as part of the statutorily required review of MP RVUs every five years as described in secti on II.C of this final rule with comment period. Of pa rticular note are the impacts on the specialties of ophthalmology (-2 percent) and optometry (-1 percent). In the course of preparation of the proposed MP RVUs,

we discovered that we had made an error in calculating the MP RVUs for ophthalmology codes in the last five year review CY that resu lted in higher MP RVUs for ophthalmology and optometry for CY 2010 than would have resulted had the MP RVUs been calculated correctly. The MP RVUs have been at a level higher than they would have been had they been calculated correctly since CY 2010. d. Combined Impact Column F of Table 93 displays the estimat ed CY 2015 combined im pact on total allowed charges by specialty of all the RVU changes. These impacts are estimated prior to the application of the negative CF update effective April 1, 201 5, applicable under the currentCMS-1612-FC 1116

statute. Table 94 (Impact of Final rule with comme nt period on CY 2015 Payment for Selected Procedures) shows the estimated impact on total payments for selected high volume procedures of all of the changes discussed previously. We have included payment rates for the period of January 1, 2015 through March 31, 2015, as well as those for April 1, 2015 through December 31, 2015. We selected these procedures for th e sake of illustration from among the most commonly furnished by a broad spectrum of specialtie s. The change in both facility rates and the nonfacility rates are shown. For an explanation of facility and nonfacility PE, we refer readers to

Addendum A of this final ru le with comment period.CMS-1612-FC 1117TABLE 94: Impact of Final Rulewith Comment Period on CY 2014Payment for Selected ProceduresFacilityNon-Facility

CPT/ HCPCS 1 MODShort Descriptor CY 2014 2 CY 2015 Jan 1– March 31 3 % Change CY 2015 April 1 – December 31 4 % Change CY 2014 2 CY 2015 Jan 1– March 31 3 % Change CY 2015 April 1 – December 31 4 % Change11721 Debride nail 6 or more $25.43 $25.42 0% $20.04 -21% $45.14 $45.47 1% $35.84 -21%17000 Destruct premalg lesion $53.38 $53.70 1% $42.34 -21% $75.23 $66.95 -11% $52.78 -30%27130 Total hip arthroplasty $1,395.30 $1,399.11 0% $1,102.99 -21% NA NA NA NA NA27244 Treat thigh fracture $1,262.04 $1,270.23 1% $1,001.38 -21% NA NA NA NA NA27447 Total knee arthroplasty $1,394.58 $1,398.76 0% $1,102.08 -21% NA NA NA NA NA33533 Cabg arterial single $1,956.28 $1,936.13 -1% $1,526.35 -22% NA NA NA NA NA35301 Rechanneling of artery $1,200.42 $1,192.90 -1% $940.42 -22% NA NA NA NA NA43239 Egd biopsy single/multiple $152.25 $152.16 0% $119.95 -21% $405.51 $409.92 1% $323.16 -20%66821 After cataract laser $324.55 $315.05 -3% $248.37 -23% $342.47 $333.67 -3% $263.05 -23%66984 Cataract surg w/iol 1 stage $673.11 $647.65 -4% $510.57 -24% NA NA NA NA NA67210 Treatment of retinal lesion $523.37 $506.95 -3% $399.58 -24% $540.92 $524.49 -3% $413.48 -24%71010 Chest x-ray 1 view frontal NA NA NA NA NA $24.00 $22.55 -6% $17.78 -26%71010 26 Chest x-ray 1 view frontal $9.31 $9.31 0% $7.34 -21% $9.31 $9.31 0% $7.34 -21%77056 Mammogram both breasts NA NA NA NA NA $116.07 $116.00 0% $91.45 -21%77056 26 Mammogram both breasts $44.42 $44.39 0% $35.00 -21% $44.42 $44.39 0% $35.00 -21%77057 Mammogram screening NA NA NA NA NA $82.75 $82.70 0% $65.20 -21%77057 26 Mammogram screening $35.82 $35.80 0% $28.22 -21% $35.82 $35.80 0% $28.22 -21%77427 Radiation tx management $186.28 $186.17 0% $146.76 -21% $186.28 $186.17 0% $146.76 -21%88305 26 Tissue exam by $38.33 $39.02 2% $30.76 -20% $38.33 $39.02 2% $30.76 -20%90935 Hemodialysis one $73.44 $73.03 -1% $57.58 -22% NA NA NA NA NA92012 Eye exam establish patient $54.81 $52.99 -3% $41.77 -24% $87.05 $85.57 -2% $67.46 -23%92014 Eye exam&tx estab pt $82.75 $80.55 -3% $63.50 -23% $126.10 $124.23 -1% $97.94 -22%93000 Electrocardiogram NA NA NA NA NA $16.84 $17.18 2% $13.55 -20%93010 Electrocardiogram report $8.60 $8.59 0% $6.77 -21% $8.60 $8.59 0% $6.77 -21%93015 Cardiovascular stress test NA NA NA NA NA $75.94 $76.97 1% $60.68 -20%CMS-1612-FC 1118FacilityNon-Facility

CPT/ HCPCS 1 MODShort Descriptor CY 2014 2 CY 2015 Jan 1– March 31 3 % Change CY 2015 April 1 – December 31 4 % Change CY 2014 2 CY 2015 Jan 1– March 31 3 % Change CY 2015 April 1 – December 31 4 % Change93307 26 Tte w/o doppler complete $45.85 $45.83 0% $36.13 -21% $45.85 $45.83 0% $36.13 -21%93458 26 L hrt artery/ventricle $325.63 $321.14 -1% $253.17 -22% $325.63 $321.14 -1% $253.17 -22%98941 Chiropract manj 3-4 $35.46 $35.09 -1% $27.66 -22% $41.55 $41.17 -1% $32.46 -22%99203 Office/outpatient visit new $77.02 $77.69 1% $61.25 -20% $108.18 $109.19 1% $86.08 -20%99213 Office/outpatient visit est $51.58 $51.20 -1% $40.36 -22% $73.08 $73.03 0% $57.58 -21%99214 Office/outpatient visit est $79.17 $78.76 -1% $62.09 -22% $107.83 $107.76 0% $84.95 -21%99222 Initial hospital care $138.63 $138.55 0% $109.23 -21% NA NA NA NA NA99223 Initial hospital care $204.19 $204.07 0% $160.80 -21% NA NA NA NA NA99231 Subsequent hospital care $39.41 $39.38 0% $31.05 -21% NA NA NA NA NA99232 Subsequent hospital care $72.36 $73.03 1% $57.58 -20% NA NA NA NA NA99233 Subsequent hospital care $104.24 $105.61 1% $83.26 -20% NA NA NA NA NA99236 Observ/hosp same date $219.24 $219.82 0% $173.29 -21% NA NA NA NA NA99239 Hospital discharge day $107.47 $108.12 1% $85.24 -21% NA NA NA NA NA99283 Emergency dept visit $61.97 $62.29 1% $49.11 -21% NA NA NA NA NA99284 Emergency dept visit $118.22 $119.22 1% $93.99 -20% NA NA NA NA NA99291 Critical care first hour $224.61 $225.91 1% $178.09 -21% $274.76 $277.10 1% $218.45 -20%99292 Critical care addl 30 min $112.48 $113.13 1% $89.19 -21% $123.23 $124.23 1% $97.94 -21%99348 Home visit est patient NA NA NA NA NA $84.54 $84.13 0% $66.33 -22%99350 Home visit est patient NA NA NA NA NA $178.40 $177.93 0% $140.27 -21%G0008 Immunization admin NA NA NA NA NA $25.08 $25.42 1% $20.04 -20%1CPT codes and descriptions are copyright 2014 American Medical Association. All Rights Reserved. Applicable FARS/DFARS apply.2The CY 2014 conversion factor is 35.8228.3Payments based on the CY 2015 conversion factor of 35.8013 effective January 1 – March 31.4Payments based on the CY 2015 conversion factor of 28.2239 effective April 1.CMS-1612-FC 1119

D. Effect of Changes to Medicare Telehealth Services Under the PFS

As discussed in section II.E. of this final rule with comment period, we are finalizing the

addition of several new codes to the list of Me dicare telehealth services. Although we expect these changes to increase access to care in ru ral areas, based on recent utilization of similar services already on the telehealth list, we estimate no significant impact on PFS expenditures

from these additions. E. Geographic Practice Cost Indices (GPCIs)

As discussed in section II.D of this final rule with comment period, we are required to

review and revise the GPCIs at least every 3 years and phase in the adjustment over 2 years (if there has not been an adjustment in the past ye ar). For CY 2015, we are not making any revisions

related to the data or the met hodologies used to calculate the GPCIs except in regard to the Virgin Islands locality discussed in section II.D. However, since the 1.0 work GPCI floor provided in section 1848(e)(1)(E) of the Act is set to expire on March 31, 2015, we have

included two set of GPCIs and GAFs for CY 2015—one set for January 1, 2015 through March 31, 2015 and another set for April 1, 2015 through December 31, 2015. The April 1, 2015 through December 31, 2015 GPCIs and GAFs reflect the statutory expiration of the 1.0 work

GPCI floor.

F. Other Provisions of the Final Rule with Comment Period Regulation

1. Ambulance Fee Schedule The statutory ambulance extender provisions ar e self-implementing. As a result, there are no policy proposals associated with these provisions or associated impact in this rule. We are finalizing our proposal to correct the dates in the Code of Federal Regulations (CFR) at §414.610(c)(1)(ii) and §414.610(c)(5)(ii) to conform the regulations to these self-implementing statutory provisions.CMS-1612-FC 1120

The geographic designations for approximate ly 92.02 percent of ZIP codes would be unchanged if we adopt OMB’s revised statistical ar ea delineations and th e updated RUCA codes. There are more ZIP codes that would change fr om rural to urban (3,038 or 7.08 percent) than from urban to rural (387 or 0.90 percent). The di fferences in the data provided in the proposed rule compared to the final rule are due to inclus ion of the updated RUCA code s. In general, it is expected that ambulance providers and supplie rs in 387 ZIP codes within 41 states may experience payment increases under the revi sed OMB delineations and the updated RUCA codes, as these areas have been redesignated fr om urban to rural. Ambulance providers and suppliers in 3, 038 ZIP codes within 46 states and Puerto Rico may experience payment

decreases under the revised OMB delineations and the updated RUCA codes, as these areas have been redesignated from rural to urban. None of the current super rural areas will lose their status upon implementation of the revised OMB delinea tions and the updated RUCA codes. We estimate that the adoption of the revised OMB delineations and the upda ted RUCA codes would have a small fiscal impact on the Medicare program. 2. Clinical Laboratory Fee Schedule There is no impact because we are merely deleting language from the Code of Federal Regulations. 3. Removal of Employment Requirements for Services Furnished “Incident to” RHC and FQHC Visits The removal of employment requirements fo r services furnished “incident to” RHC and FQHC visits will provide RHCs and FQHCs with greater flexibili ty in meeting their staffing needs, which may result in increasing access to care in underserved areas. There is no cost to the federal government, and we cannot estimate a cost savings for RHCs or FQHCs.

4. Access to Identifiable Data for the Ce nter for Medicare a nd Medicaid ModelsCMS-1612-FC 1121

Given that, in general, participants in I nnovation Center models receive funding support to participate in model tests, we do not anticipate an impact. In those cases where there is a cost associated with the data reporting, such costs wi ll vary by project, and th us cannot be laid out with specificity here. We do, how ever, expect the costs to be c overed by payments associated

with the model test. 5. Local Coverage Determination Process for Clinical Diagnostic Laboratory Tests The Local Coverage Determination Process fo r Clinical Diagnostic Laboratory Tests will not be finalized. Therefore, there is no imp act to CY 2015 physician payments under the PFS. 6. Private Contracting/Opt Out

We corrected cross-references and outdat ed terminology in the regulations that we inadvertently neglected to revise, and changed the appeals process used for certain appeals relating to opt-out private contr acting. We anticipate no or minima l impact as a result of these

corrections. 7. Payment Policy for Locum Tenens Physicians We did not issue any new or revise d requirements. There is no impact. 8. Reports of Payments or Other Transf ers of Value to Covered Recipients The changes to the Transparency Reports and Reporting of Physician Ownership or

Investment Interests in section III.I of this final rule with comment period would not impact CY 2015 physician payments under the PFS. 9. Physician Compare There will be no impact for the Physician Compare website because we are not collecting any new information specifically for the Physic ian Compare website. The information derived for Physician Compare comes from other programs that already collect data, including but not limited to the Physician Quality Reporting Syst em (PQRS) and the Medicare Shared SavingsCMS-1612-FC 1122

Program. 10. Physician Quality Reporting System According to the 2012 Reporting Experience, “more than 1.2 million eligible professionals were eligible to participate in the 2012 PQRS, Medicare Shared Savings Program,

and Pioneer ACO Model.” 40 In this burden estimate, we a ssume that 1.2 million eligible professionals, the same number of eligible profes sionals eligible to participate in the PQRS in 2012, will be eligible to participat e in the PQRS. Since all eligib le professionals are subject to the 2017 PQRS payment adjustment, we estimate th at all 1.2 million eligible professionals will participate, (which includes, for the purposes of this discussion, being eligible for the 2017 PQRS payment adjustment) in the PQRS in 2015 for purposes of m eeting the criteria for satisfactory reporting (or, in lieu of satisfactor y reporting, satisfactory pa rticipation in a QCDR) for the 2017 PQRS payment adjustment. Historically, the PQRS has never experienced 100 percent participation in reporting for the PQRS. Therefore, we believe that although 1.2 million eligible professionals will be subject to the 2017 PQRS payment adjustment , not all eligible participants will actually report quality measures data for purposes of the 2017 PQRS payment adjustment. In this burden estimate, we will only provide burden estimates for the eligible professionals and group practices who attempt to submit quality measures data for purposes of the 2017 PQRS payment adjustment. In 2012, 435,871 eligible professionals (36 percent) eligib le professionals (including those who belonged to group practices that reported under the GPRO a nd eligible professionals within an ACO that participated in the PQRS via the Shared Savings Program or Pioneer ACO Model) participated in the PQRS, Medicare Shared Saving s Program, or Pioneer ACO Model. 41 We expect to see a

40 Centers for Medicare and Medicaid Services, 2012 Reporting Experience Including Trends (2007—2013): Physician Quality Reporting System and Electronic Prescribing (eRx) Incentive Program , March 14, 2014, at xiii. 41 Id. at XV.CMS-1612-FC 1123

significant increase in particip ation in reporting for the PQRS in 2015 than 2012 as eligible professionals were not subject to a PQRS paym ent adjustment in 2012. Last year (78 FR 74793), we estimated that we would see a 50 percent part icipation rate in 2015. We still believe that a 14 percent increase in participation from 2012 is reas onable in 2015. Therefore, we estimate that 50 percent of eligible professi onals (or approximately 600,000 elig ible professionals) will report quality measures data for purposes of the 2017 PQRS payment adjustment. For participation in the PQRS using the claims-based reporting mechanism, according to the 2011 PQRS and eRx Experience Repor t, in 2011, 229,282 of the 320,422 eligible professionals (or 72 percent) of eligible pr ofessionals used the claims-based reporting mechanism. According to the 2012 Reporting Experience, 248,206 elig ible professionals participated in the PQRS using the claims-based reporting mechanism in 2012. 42 Preliminary estimates show that 252,567 eligib le professionals participated in the PQRS using the claimsbased reporting mechanism in 2013. 43 According to the historical data cited above, although the claims-based reporting mechanism is still the most widely-used reportin g mechanism, we are seeing a decline in the percentage of participants using the claims-based reporting mechanism in the PQRS. Although these eligible professionals continue to participate in the PQRS, these eligible professionals have started to shift towards the use of othe r reporting mechanisms – mainly the GPRO web interface (whether used by a PQRS GPRO or an ACO participating in the PQRS via the Medicare Shared Savings Program or Pioneer ACO model), registry, or the EHRbased reporting mechanisms. For purposes of th is burden estimate, based on PQRS participation using the claims-based reporting mechanism in 2012 and 2013, we will assume that approximately 250,000 eligible professionals will part icipate in the PQRS using the claims-based

42 Id . at xvi. See Figure 4. 43 Id

.CMS-1612-FC 1124

reporting mechanism. For participation in the PQRS using a qualified registry or QCDR, in 2011, approximately 50,215 (or 16 percent) of the 320,422 elig ible professionals participating in PQRS used the qualified registry-based reporting mechanism. According to the 2012 Reporting Experience, 36,473 eligible professi onals reported individual meas ures via the registry-based reporting mechanism, and 10,478 eligible profes sionals reporting measures groups via the registry-based reporting mechanism in 2012. 44 Therefore, approximately 47,000 eligible professionals participated in the PQRS using the registry-based reporting mechanism in 2012. Please note that we currently have no data on participation in the PQRS via a QCDR as 2014 is the first year in which an eligible professiona l may participate in the PQRS via a QCDR. We believe that the rest of the eligible professi onals not participating in other PQRS reporting mechanisms will use either the registry or QCDR reporting mechanisms for the following reasons: (1) the PQRS measures set is moving away from use of claims-based measures and moving towards the use of regist ry-based measures; or (2) we believe the number of QCDR vendors will increase as the QCDR reporting mech anism evolves. Therefore, based on these assumptions, we expect to see a significant jump from 47,000 eligible professionals (the remaining number of eligible professionals not participating via the clai ms, EHR, or GPRO web interface reporting mechanisms) to approximately 165,000 eligible professionals using either the registry-based reporting mechanism or QCDR in 2015. We believe th e majority of these eligible professionals will participate in the PQRS usi ng a QCDR, as we presume QCDRs will be larger

entities with more members. For participation in the PQ RS using the EHR-based reporting mechanism, according to the 2011 PQRS and eRx Experience Report, in 2011, 560 (or less than 1 percent) of the 320,422

44 Id . at xvi. See Figure 4.CMS-1612-FC 1125

eligible professionals particip ating in PQRS used the EHR-ba sed reporting mechanism. 2012 saw a sharp increase in repor ting via the EHR-based reportin g mechanism. Specifically, according to the 2012 Reporting Experience, in 2012, 19,817 eligible professionals submitted quality data for the PQRS through a qualified EHR. 45 We believe the nu mber of eligible professionals and group practices using the EHR-based reporting mechanism will steadily increase as eligible professionals become more familiar with EHR products and more eligible professionals participate in pr ograms encouraging use of an EHR, such as the EHR Incentive Program. In particular, we belie ve eligible professionals will tr ansition from using the claimsbased to the EHR-based reporting mechanisms. To account for this anticipated increase, we continue to estimate that approximately 50,000 eligib le professionals, whether participating as an individual or part of a group practice under the GPRO, would use the EHR-based reporting

mechanism in CY 2015. For participation in the PQRS using the GPRO web interface, as we noted in last year’s estimate, according to the 2011 Experience Report, approximately 200 group practices participated in the GPRO in 2011. According to the 2012 Reporting Experience, 66 practices participated in the PQRS GPRO. 46 In addition, 144 ACOs participated in the PQRS GPRO through either the Medicare Shared Savings Program (112 ACOs) or Pioneer ACO Model (32 practices). 47 These group practices encompass 134,510 e ligible professional s (or approximately 140,000 eligible professionals). 48 Since it seems that roughly 2 00 group practices participated in the GPRO in 2011 and 2012, based on these numbers, we will assume that 200 group practices

45 Id . at xv. 46 Id . at xv. 47 Id . at xvi. 48 Id . at 18.CMS-1612-FC 1126

(accounting for approximately 135,000 eligible profe ssionals) will participat e in the PQRS using

the GPRO web interface in 2015. Please note that, while we are finalizing the reporting of CAHPS surv ey measures using a CMS-certified survey vendor, we are not includi ng this reporting mechanism in this impact statement as we believe that eligible professi onals wishing to report CAHPS survey measures will do so for purposes other than the PQRS. (a) Assumptions for Burden Estimates For the PQRS, the burden associated with th e requirements of this voluntary reporting

initiative is the time and effort associated w ith individual eligible professionals identifying applicable quality measures for which they can report the necessary information, selecting a reporting option, and reporting the information on their selected measures or measures group to CMS using their select ed reporting option.

We believe the labor associated with eligible professionals and group practices reporting quality measures data in the PQRS is primarily handled by an eligible professional’s or group practice’s billing clerk or computer analyst trained to report qualit y measures data. Therefore, we will consider the hourly wage of a billing clerk and computer analyst in our estimates. For purposes of this burden estimate, we will a ssume that a billing clerk will handle the administrative duties associated with participa ting in the PQRS. According to information published by the Bureau of La bor Statistics, available at http://www.bls.gov/oes/2013/may/oes433021.htm , the mean hourly wage for a billing clerk is approximately $16.80/hour. Therefore, for purpos es of handling administrative duties, we estimate an average labor cost of $16.00/hour. In addition, for purposes of this burden estimate, we will assume that a computer analyst will engage in the duties associated with the reporting of quality measures. According to information published by the Bureau of Labor Statistics,CMS-1612-FC 1127

available at http://www.bls.gov/oes/2013/may/oes151121.htm , the mean hourly wage for a computer analyst is approximately $41.00/hour. Th erefore, for purposes of reporting on quality measures, we estimate an average labor cost of $41.00/hour. Please note that, in assessing the burden estimates below, to account for benefits a nd overhead associated with labor in addition to the hourly wage costs described above, we ar e doubling the wage rates in our estimates. For individual eligible professionals, the burden associated with the requirements of this reporting initiative is the time and effort associ ated with eligible professionals identifying applicable quality measures for which they can report the necessary information, collecting the necessary information, and reporting the information needed to re port the eligible professional’s

measures. We believe it is difficult to accurately quantify the burden because eligible professionals may have different processes for in tegrating the PQRS into their practice’s work flows. Moreover, the time needed for an eligible professional to review the quality measures and other information, select measures applicable to his or her patie nts and the services he or she furnishes to them, and incorporate the use of qual ity data codes into the office work flows is expected to vary along with the number of measures that are pot entially applicable to a given professional’s practice. Since elig ible professionals are generally required to report on at least 9 measures covering at least 3 National Quality St rategy domains criteria for satisfactory reporting (or, in lieu of satisfactory re porting, satisfactory participatio n in a QCDR) for the 2017 PQRS payment adjustment, we will assume that each eligible professional reports on an average of 9

measures for this bu rden analysis. For eligible professionals who are participati ng in PQRS for the first time, we will assign

5 total hours as the amount of time needed for an eligible professional’s billing clerk to review the PQRS Measures List, review the various re porting options, select the most appropriate reporting option, identify the applicable measures or measures groups for which they can reportCMS-1612-FC 1128

the necessary information, review the measure specifications for the selected measures or measures groups, and incorporate reporting of the se lected measures or measures groups into the

office work flows. The measures list contains the measure title and brief summary information for the eligible professional to review. Assuming the eligible professional has received no training from his/her specialty soci ety, we estimate it will take an eligible professional’s billing clerk up to 2 hours to review this list, review the reporting opti ons, and select a reporting option and measures on which to report. If an eligib le professional has rece ived training, then we

believe this would take less time. We believ e 3 hours is plenty of time for an eligible professional to review the measure specifications of 9 measures or 1 measures group they select to report for purposes of participating in PQRS and to develop a mechanism for incorporating reporting of the selected measures or measures gr oup into the office work flows. Therefore, we believe that the start-up cost for an eligible prof essional to report PQRS qua lity measures data is 5 hours x $32/hour = $160. We believe the burden associated with actually reporting the quality measures will vary depending on the reporting mechanism selected by the eligible professional. As such, we break down the burden estimates by eligible profession als and group practices participating in the GPRO according to the reporting mechanism used. (b) Burden Estimate for PQRS Reporting by Indi vidual Eligible Professionals: Claims-Based Reporting Mechanism For the claims-based reporting option, eligible professionals must gather the required information, select the appropriate quality data codes (QDCs), and incl ude the appropriate QDCs on the claims they submit for payment. The PQ RS will collects QDCs as additional (optional) line items on the existing HIPAA transaction 837-P and/or CMS Form 1500 (OCN: 0938-0999).CMS-1612-FC 1129

We do not anticipate any new forms and or any modi fications to the existing transaction or form. We also do not anticipate changes to the 837-P or CMS Form 1500 for CY 2015. We estimate the cost for an eligible professi onal to review the list of quality measures or measures groups, identify the applicable measures or measures group for which they can report the necessary information, incorporate reporting of the selected measures into the office work flows, and select a PQRS reporting option to be approximately $410 per eligible professional ($82 per hour x 5 hours). Based on our experience with the Physicia n Voluntary Reporting Program (PVRP), we

continue to estimate that the time needed to perform all the steps necessary to report each measure (that is, reporting the relevant quality da ta code(s) for 9 measures measure) would range from 15 seconds (0.25 minutes) to over 12 minutes for complicated cases and/or measures, with the median time being 1.75 minutes. To report 9 measures, we estimate that it would take approximately 2.25 minutes to 108 minutes to pe rform all the steps necessary to report 9

measures. Per measure, at an average labor cost of $82/ hour per practice, the cost associated with this burden will range from $0.34 in labor to ab out $16.40 in labor time for more complicated cases and/or measures, with the cost for the median practice be ing $2.40. To report 9 measures, using an average labor cost of $82/hour, we esti mated that the time cost of reporting for an eligible professional via claims would range from $3.07 (2.25 minutes or 0.0375 hours x $82/hour) to $147.60 (108 minutes or 1.8 hours x $82/hour) per reported case.

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 ea ch of the PQRS measures was 9. Since weCMS-1612-FC 1130

reduced the required reporting rate by over one-third to 50 percent, then for purposes of this burden analysis we will assume that an eligible professional or eligible professional in a group practice will need to report each selected m easure for 6 reporting instances. The actual number of cases on which an eligible professional or gro up practice is required to report quality measures data will vary, however, with the eligible prof essional's or group pract ice’s patient population and the types of measures on which the eligible professional or group prac tice chooses to report (each measure's specifications includes a required reporting frequency). Based on the assumptions discussed previousl y, we estimate the total annual reporting burden per individual eligible pr ofessional associated with cl aims-based reporting will range from 13.5 minutes (0.25 minutes per measure x 9 measures x 6 cases per measure) to 648 minutes (12 minutes per measure x 9 measures x 6 cases per measure), w ith the burden to the median practice being 94.5 minut es (1.75 minutes per measure x 9 measures x 6 cases). We estimate the total annual reporting co st per eligible professional or eligible pr ofessional in a group practice associated with claims-based re porting will range from $18.36 ($0.34 per measure x 9 measures x 6 cases per measure) to $885.60 ($16.40 per measure x 9 measures x 6 cases per measure), with the cost to the median pract ice being $129.60 per eligible professional ($2.40 per measure x 9 measures x 6 cases per measure). (c) Burden Estimate for PQRS Reporting by Individual Eligible Professionals and Group Practices: Qualified Registry-based and QCDR-based Reporting Mechanisms For qualified registry-based and QCDR-based reporting, there will be no additional time burden for eligible professionals or group practices to report da ta to a qualified registry as eligible professionals and group pr actices opting for qualified regist ry-based reporti ng or use of a QCDR will more than likely already be reporting da ta to the qualified registry for other purposes and the qualified registry will merely be re-packag ing the data for use in the PQRS. Little, ifCMS-1612-FC 1131

any, additional data will need to be reported to the qualified registry or QCDR solely for purposes of participation in the PQRS. However, eligible professionals and group practices will need to authorize or instruct the qualified regi stry or QCDR to submit quality measures results and numerator and denominator data on quality m easures to CMS on their behalf. We estimate

that the time and effort associated with this will be approximately 5 minutes per eligible professional or eligible profe ssional within a group practice. Based on the assumptions discussed above and in Part B of this supporting statement, Table 95 provides an estimate of the total a nnual burden hours and total annual cost burden associated with eligible professionals using the qualified registry-based or QCDR-based reporting mechanism. Please note that, unlike th e claims-based reporting mechanism that would require an eligible professional to report data to us on quality measures on multiple occasions, an eligible professional would not be required to submit this data to us, as the qualified registry or QCDR would perform this function on the eligible professional’s behalf. (d) Burden Estimate for PQRS Reporting by Individual Eligible Professionals and Group Practices: EHR-Based Reporting Mechanism For EHR-based reporting, which includes EHR reporting via a direct EHR product and an EHR data submission vendor’s prod uct, the eligible professional or group practice must review the quality measures on which we will be accepting PQRS data extracted from EHRs, select the appropriate quality measures, extract the necessary clinical data from his or her EHR, and submit the necessary data to the our designa ted clinical data warehouse. For EHR-based reporting for the PQRS, the i ndividual eligible prof essional or group practice may either submit the quality measures data directly to us from their EHR or utilize an

EHR data submission vendor to submit the data to us on the eligible professional’s or group practice’s behalf. To submit data to us directly from their EHR, the el igible professional orCMS-1612-FC 1132

eligible professional in a group practice must ha ve access to our specified identity management system, such as IACS, which we believe takes le ss than 1 hour to obtain. Once an eligible professional or eligible professional in a group pr actice has an account for our specified identity management system, he or she will need to extr act the necessary clinical data from his or her EHR, and submit the necessary data to the our de signated clinical data warehouse. With respect to submitting the actual data file for the respective reporting period, we believe that this will take an eligible professional or group practice no mo re than 2 hours, depending on the number of patients on which the eligible professional or group practice is submitting. We believe that once the EHR is programmed by the vendor to allow data submission to us, the burden to the eligible professional or group practice asso ciated with submission of data on quality measures should be minimal as all of the information required to report the measure should already reside in the eligible professional's or group practice’s EHR. (e) Burden Estimate for PQRS Reporting by Gr oup Practices Using the GPRO Web Interface With respect to the process for group practi ces to be treated as satisfactorily submitting quality measures data under the PQRS, group practic es interested in participating in the PQRS through the group practice reporting option (GPRO) must comp lete a self-nomination process similar to the self-nomination process required of qualified registries. However, since a group practice using the GPRO web inte rface would not need to determine which measures to report under PQRS, we believe that the self-nomina tion process is handled by a group practice’s administrative staff. Therefore, we estimate that the self-nomination process for the group practices for the PQRS involves approximately 2 hours per group practice to review the PQRS GPRO and make the decision to pa rticipate as a group ra ther than individually and an additional 2 hours per group practice to draft th e letter of intent for self-n omination, gather the requested TIN and NPI information, and provide this requested information. It is es timated that each self-CMS-1612-FC 1133

nominated entity will also spend 2 hours undergoing the vetting process with CMS officials. We assume that the group practice staff involved in the group practice self-nomination process has an average practice labor cost of $32 per hour. Therefore, assu ming the total burden hours per group practice associated with the group practice se lf-nomination process is 6 hours, we estimate the total cost to a group practice associated with the group practice self-nomination process to be approximately $192 ($32 per hour x 6 hours per group practice). The burden associated with the group practi ce reporting requirements under the GPRO is the time and effort associated with the group pr actice submitting the quality measures data. For physician group practices, this would be the time associated with the physician group completing

the web interface. We estimate that the time an d effort associated with using the GPRO web interface will be comparable to the time and effort associated to using the PAT. As stated above, the information collection components of the PAT have been reviewed by OMB and was approved under OMB control number 0938-0941- Fo rm 10136, with an expiration date of December 31, 2011 for use in the PGP, MCMP, a nd EHR demonstrations. As the GPRO was only recently implemented in 2010, it is difficult to determine the ti me and effort associated with the group practice submitting the quality measures da ta. As such, we will use the same burden estimate for group practices par ticipating in the GPRO as we use for group practices participating in the PGP, MCMP, and EHR demons trations. Since these changes will not have any impact on the information collection requireme nts associated with the PAT and we will be using the same data submission process used in the PGP demonstration, we estimate that the burden associated with a group practice completi ng data for PQRS under the web interface will be the same as for the group practice to complete the PAT for the PGP demonstration. In other words, we estimate that, on average, it will ta ke each group practice 79 hours to submit qualityCMS-1612-FC 1134

measures data via the GPRO web interface at a cost of $82 per hour. Therefore, the total estimated annual cost per group practice is estimated to be approximately $6,478. Tables 95 and 96 provide our total estimated costs for reporting in the PQRS for the 2017 PQRS payment adjustment, the reporti ng periods of which occur in CY 2015. TABLE 95: Summary of Burden Estimates for Eligible Professionals and/or Group Practices using the Claims, Qualified regis try, and EHR-based Reporting Mechanisms for the 2017 PQRS Payment Adjustment

Minimum Burden Estimate Maximum Burden Estimate Estimated Annual Burden Hours for Claims-based Reporting (for individual eligible professionals only) 1,306,025 3,948,920 Estimated Annual Burden Hours for Qualified registry-based or QCDR-based Reporting 1,333,695 1,333,695 Estimated Annual Burden Hours for EHR-based Reporting 450,000 450,000 Estimated Total Annual Burden Hours for Eligible Professionals or Eligible Professionals in a Group Practice 3,089,720 5,732,615 Estimated Cost for Claims-based Reporting (for individual eligible professionals only) $107,090,000 $323,900,000 Estimated Cost for Qualified registry-based Reporting $109,362,000 $109,362,000 Estimated Cost for EHR-based Reporting $32,800,000 $32,800,000 Estimated Total Annual Cost for Eligible Professionals or Eligible Professionals in a Group Practice $249,252,000 $466,062,000CMS-1612-FC 1135

TABLE 96: Estimated Costs of Group Prac tices using the GPRO Web Interface to Participate in the PQRS for th e 2017 PQRS Payment Adjustment Maximum Burden Estimate Estimated # of Participating Group Practices 200 Estimated # of Burden Hours Per Group Prac tice to Self-Nominate to Participate in PQRS and the Electronic Prescribing Incentive Program Under the Group Practice Reporting Option 6

Estimated # of Burden Hours Per Group Practice to Report Quality Measures 79 Estimated Total Annual Burden Hours Per Group Practice 85 Estimated Total Annual Burden Hours for Group Practices 17,000 Estimated Cost Per Group Practice to Self-N ominate to Participate in PQRS for the Group Practice Reporting Option $192 Estimated Cost Per Group Practice to Report Quality Measures $6,478 Estimated Total Annual Cost Per Group Practice $6,670 Annual Burden Cost for Group Practices $ 1,334,000

11. EHR Incentive Program The changes to the EHR Incentive Program in section III.L of this final rule with comment period would not impact CY 2015 physician payments under the PFS. 12. Medicare Shared Saving Program The requirements for participating in the Medicare Shared Saving Program and the impacts of these requirements were established in the final rule implementing the Medicare Shared Savings Program that appeared in the Federal Register on November 2, 2011 (76 FR 67802). The proposals for the Medicare Shared Savings Program set forth in the CY 2015 MPFS proposed rule revisited the current quality performance standard, proposed changes to the quality measures, proposed modifi cations to the timeframe between updates to the quality performance benchmarks, and proposed to establish an additional incentive to reward ACO quality improvement. Since the policies bei ng adopted in this final rule with comment period do not increase the quality re porting burden for ACOs participating in the Shared Savings Program and their ACO participan ts and ACO providers/suppliers, there is no impact for these policies.CMS-1612-FC 1136

13. Value-Based Payment Modifier an d the Physician Feedback Program Section 1848(p) of the Act requires that we establish a VM and a pply it to specific physicians and groups of physicians the Secretar y determines appropria te starting January 1, 2015 and to all physicians and groups of physic ians by January 1, 2017. Section 1848(p)(4)(C) of the Act requires the VM to be budget neutral. Budget-neutrality means that, in aggregate, the increased payments to high performing physicians and groups of physicia ns equal the reduced payments to low performing physicians and groups of physicians. The changes to the VM in section III.N of th is final rule with comment period will not impact CY 2015 physician payments under the PFS. We finalized the VM policies that would impact the CY 2015 physician payments under th e PFS in the CY 2013 PFS final rule with comment period (77 FR 69306-69326).

In the CY 2013 PFS final rule with comment period, we finalized policies to phase-in the VM by applying it starting January 1, 2015 to payments under the Medicare PFS for physicians in groups of 100 or more eligible pr ofessionals. We identify a group of physicians as a single taxpayer identificati on number (TIN). We apply the VM to the items and services billed by physicians under the TIN, not to other eligible professionals that also may bill under the TIN. We established CY 2013 as the performa nce period for the VM that will be applied to payments during CY 2015 (77 FR 69314). We also fi nalized that we will not apply the VM in CYs 2015 and 2016 to any group of physicians that is participating in the Medicare Shared Savings Program, the Pioneer ACO Model, or th e Comprehensive Primary Care Initiative, or

other similar Innovation Center or CMS initiatives (77 FR 69313). We finalized policies to determine the am ount of the VM for CY 2015 by categorizing groups of physicians with 100 or more eligible professionals into two categories. Category 1 includes groups of physicians that either (a) self-nominate for th e PQRS as a group and report atCMS-1612-FC 1137

least one measure or (b) elect the PQRS Admi nistrative Claims option as a group. Category 2 includes groups that do not fall w ithin either of the two subcate gories (a) or (b) of Category 1. Groups within Category 1 may elect to have th eir VM for CY 2015 calculated using the qualitytiering methodology, which could result in an up ward, neutral, or downward adjustment amount. The VM for groups of physicians in Cate gory 1 that do not elect-quality tiering is 0.0 percent, meaning that these groups will not rece ive a payment adjustment under the VM for CY 2015. For the groups that are in Category 2, the VM for the CY 2015 payment adjustment period is -1.0 percent. Under the quality-tiering approach, each group’s quality and cost composites are classified into high, average, and low categor ies depending upon whether the composites are at

least one standard deviation a bove or below the mean. We co mpare the group’s quality of care composite classification with the cost composite classification to determine the VM adjustment for the CY 2015 payment adjustment period according to the amounts in Table 97. TABLE 97: 2015 Value-Based Payment Modifier Amounts under Quality-Tiering Cost/Quality Low Quality Average Quality High Quality Low Cost +0.0% +1.0x* +2.0x* Average Cost -0.5% +0.0% +1.0x* High Cost -1.0% -0.5% +0.0% * Groups of physicians eligible for an additional +1.0x if (1) reporting Physician Quality Reporting System quality measures through the GPRO we b-interface or CMS-qualified re gistry, and (2) average bene ficiary risk score is in the top 25 percent of all beneficiary risk scores.

To ensure budget neutrality, we first aggr egate the downward payment adjustments in Table 97 for those groups in Category 1 that have elected quality tiering with the -1.0 percent downward payment adjustments for groups of physic ians subject to the VM that fall within Category 2. Using the aggregate downward paymen t adjustment amount, we then calculate the upward payment adjustment factor (x). These calculations will be done after the performance period has ended.CMS-1612-FC 1138

In the proposed rule, we presented estimates on the number of eligible professionals and physician groups, by group size, based on CY 2012 cl aims data that were used to produce the 2012 QRURs, which were available to groups of 25 or more eligible professionals on September 16, 2013. The findings from the CY 2012 QRUR s are available on the CMS website athttp://www.cms.gov/Medicare/Medicare-Fee-for-ServicePayment/PhysicianFeedbackProgram/2012-QRUR.html in a document titled “Experience Report for the Performance Year 2012 Qualit y and Resource Use Reports”. On September 30, 2014, we made QRURs ava ilable to all groups of physicians and physicians who are solo practitioners based on their performance in CY 2013. We also completed the analysis of the impact of the VM in CY 2015 on physicians in groups with 100 or more eligible professionals base d on their performance in CY 2013 and present a summary of the findings below. Please note that the impact of the policies for the CY 2017 VM finalized in this final rule with comment period will be discussed in the PFS rule for CY 2017. Based on the methodology codified in §414.1210(c), there are 1,010 groups of 100 or more eligible professionals (as identified by their Taxpayer Identific ation Numbers (TINs)) whose physicians’ payments under the Medicare PFS will be subject to the VM in the CY 2015 payment adjustment period. Of these 1,010 groups subject to the CY 2015 VM, 706 groups met the criteria for inclusion in Category 1. As noted above, Category 1 for the CY 2015 VM includes groups of physicians that either (a) self-nominate for th e PQRS as a group and report at least one measure or (b) elect the PQRS Administrative Claims option as a group. Of the 706 groups in Category 1, 133 groups elected in 2013 to have their CY 2015 VM calculated using the quality-tiering methodology; th erefore, these groups will receive an upward, neutral, or downward adjustment in CY 2015 ba sed on their performance on the quality and cost

measures finalized for the CY 2015 VM in the CY 2013 PFS final rule with comment period (77CMS-1612-FC 1139

FR 69306-69326). We note that there were 21 groups for which we had insufficient data to calculate their quality or cost composite; therefore, these groups will receive a neutral adjustment to their payments in CY 2015. Of the 112 group s for which we were able to calculate both quality and cost composites, we found that 16 groups are in tiers that will result in an upward adjustment of +1.0x; 9 groups are in tiers that w ill result in a downward adjustment of between - 0.5 and -1.0 percent; and 87 groups are in tiers that will result in a neutral adjustment to their payments in CY 2015. Of the groups that are e ligible for an upward adjustment, none of the groups are eligible to receive an additional + 1.0x adjustment to their Medicare payments for treating high-risk beneficiaries. Table 98 show s the distribution of the 112 groups that elected quality-tiering into the various quality and cost tiers. Please note that CMS will announce the upward payment adjustment factor (x) in the Fall of 2014 on the CMS website athttp://www.cms.gov/Medicare/Medicare-Fee-for-ServicePayment/PhysicianFeedbackProgram/ValueBasedPaymentModifier.html

.

TABLE 98: Distribution Using 2013 Data of Qu ality and Cost Tiers for Groups with 100 or More Eligible Professionals that Elected Quality-Tiering for Which a Quality and Cost Composite Score Could Be Calculated (112 Groups)

Cost/Quality Low Quality Average Quality High Quality Low Cost +0.0% (0) +1.0x (2) +2.0x (0) Average Cost -0.5% (5) +0.0% (87) +1.0x (14) High Cost -1.0% (2) -0.5% (2) +0.0% (0)

Of the 706 groups in Category 1, 573 groups elected to not have their CY 2015 VM calculated using the quality-tie ring methodology; therefore, thei r VM will be 0.0 percent, meaning that these groups will not receive a payment adjustment under the VM in CY 2015. Of the 1,010 groups subject to the CY 2015 VM, 304 groups met the criteria for inclusion in Category 2. As noted above, Category 2 includes groups that do not fall within either of theCMS-1612-FC 1140

two subcategories (a) or (b) of Category 1. Th ere were 289 groups that di d not self-nominate for the PQRS as a group, and 15 groups that self-nom inated for the PQRS as a group, but did not report at least one measure. Groups in Categor y 2 will be subject to a -1.0 percent payment adjustment under the VM during the CY 2015 payment adjustment period. Please note that in CY 2015, only the physicia ns in groups with 100 or more eligible professionals that are in Category 1 and elec ted quality-tiering will be subject to upward, downward, or no payment adjustment under th e VM according to Table 98. Additionally, physicians in groups with 100 or more eligible professionals that fall in Category 2 will be subject to the -1.0 percent VM in CY 2015. We note that in the 2013 QRUR Experience Repor t, which will be released in the next few months, we will provide a detailed analysis of the impact of the 2015 VM policies on groups of 100 or more eligible profe ssionals subject to the VM in CY 2015, including findings based on the data contained in the 2013 QRURs for all gr oups of physicians and solo practitioners.

14. Interim Revisions to the Electronic H ealth Record (EHR) Incentive Program

This interim final rule will allow us flex ibility in setting the deadline for significant hardship exception applications. We refer reader s to the impact analyses included in the final rule titled “Medicare and Medicaid Programs; Electronic Health Record Incentive Program— Stage 2” (77 FR 53698 through 54162) and Medicare and Medicaid Programs; Modifications to

the Medicare and Medicaid Elec tronic Health Record (EHR) Incentive Programs for 2014 and Other Changes to the EHR Incentive Program; and Health Information T echnology; Revisions to the Certified EHR Technology Definition and EHR Certification Changes Related to Standards; Final Rule (79 FR 52911-52933).

G. Alternatives ConsideredCMS-1612-FC 1141

This final rule with comment period cont ains a range of policies, including some provisions related to specific st atutory provisions. The preceding preamble provides descriptions of the statutory provisions that are addressed, identifie s those policies when discretion has been exercised, presents rationale for our final policie s and, where relevant, al ternatives that were

considered. H. Impact on Beneficiaries There are a number of changes in this final rule with comment period that would have an

effect on beneficiaries. In general, we believe that many of the 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; improved accu racy in payment through revi sions to the inputs used to calculate payments under the PFS; and revisions to payment for Part B drugs will have a positive impact and improve the quality and value of care provided to Medicare beneficiaries. Most of the aforementioned policy changes could result in a change in beneficiary liability as relates to coinsura nce (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 94, the CY 2014 national paym ent amount in the nonfaci lity setting for CPT code 99203 (Office/outpatient visit, new) is $108.18, which means th at in CY 2014 a beneficiary would be responsible for 20 per cent of this amount, or $21.64. Ba sed on this final rule with comment period, using the January 1 – Ma rch 31, 2015 CF of 35.8013, the CY 2015 national payment amount in the nonfacility setting fo r CPT code 99203, as shown in Table 94, is $109.19, which means that, in CY 2015, the beneficiary co insurance for this serv ice would be $21.84. In addition, we are finalizing a cha nge in our definition of colorect al cancer screening test. As a result, beneficiary liability will not be applied to anesthesia billed in conjunction with aCMS-1612-FC 1142

colorectal cancer screening test. I. Accounting Statement As required by OMB Circul ar A-4 (available at http://www.whitehouse.gov/om b/circulars/a004/a-4.pdf ), in Table 99 (Accounting Statement), we have prepared an accounting statement

. This estimate includes growth in incurred benefits

from CY 2014 to CY 2015 based on the FY 2015 President' s Budget baseline. Note that subsequent legislation changed the updates for 2015 from those shown in the 2015 President’s Budget baseline. TABLE 99: Accounting Statement: Cla ssification of Estimated Expenditures CATEGORY TRANSFERS CY 2015 Annualized Monetized Tran sfers Estimated decrease in expenditures of $14.7 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 2015 Annualized Monetized Transfers Estim ated increase in payment of $234 million. From Whom To Whom? Federal Government to eligible professionals who satisfactorily participate in the Physician Quality Reporting System (PQRS). TABLE 100: Accounting Statement: Classifi cation of Estimated Costs, Transfer, and Savings Category Transfer CY 2015 Annualized Monetized

Transfers of beneficiary cost coinsurance. $9 million

From Whom to Whom? Benefici aries to Federal Government

J. 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 preceding portion of this preamble, provides a Regulatory Impact Analysis.CMS-1612-FC 1143

In accordance with the provisions of Executive Order 12866, this regulation was reviewed by the Office of Management and Budget.CMS-1612-FC 1144

List of Subjects

42 CFR Part 403 Grant programs-health, Health insurance, Hospitals, Intergovernmental relations, Medicare, Reporting and recordkeeping requirements.

42 CFR Part 405 Administrative practice and pr ocedure, Health facilities, Health professions, Kidney diseases, Medical devices, Medi care, Reporting and recordkeepi ng requirements, Rural areas, X-rays.

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 411 Kidney diseases, Medicare, Physician Referral, Reporting and recordkeeping requirements.

42 CFR Part 412 Administrative practice and procedure, Health facilitie s, Medicare, Puerto Rico, Reporting and recordkeeping requirements.

42 CFR Part 413 Health facilities, Kidney di seases, Medicare, Reporting and recordkeeping requirements.

42 CFR Part 414 Administrative practice and pr ocedure, Health facilities, Health professions, Kidney diseases, Medicare, Reporting a nd recordkeeping requirements.

42 CFR Part 425CMS-1612-FC 1145

Administrative practice and pro cedure, Health facilities, H ealth professions, Medicare, and Reporting and recordkeeping requirements.

42 CFR Part 489 Health facilities, Medicare, Reporting and recordkeeping requirements.

42 CFR Part 495 Administrative practice and pro cedure, Electronic health record s, Health facilities, Health professions, Health maintenance organizations (H MO), Medicaid, Medicare, Penalties, Privacy, Reporting and recordkeeping requirements.

42 CFR Part 498 Administrative practice and pro cedure, Health facilities, H ealth professions, Medicare, Reporting and recordkeeping requirements.CMS-1612-FC 1146

For the reasons set forth in the preamble, the Centers for Medicare & Me dicaid Services amends 42 CFR chapter IV as set forth below:—

PART 403—SPECIAL PROGRAMS AND PROJECTS 1. The authority citation for part 40 3 continues to read as follows: Authority: 42 U.S.C. 1395b-3 and Secs. 1102 and 1871 of the Social Security Act (42 U.S.C. 1302 and 1395hh). §403.902 [Amended] 2. In §403.902, remove the definition of “Covered device”. 3. Section 403.904 is amended by – A. Revising paragraphs (c)(8), (d)(3), and (d)(4). B. Adding paragraphs (d)(5) and (d)(6). C. Revising paragraph (f)(1)(iv). D. Removing paragraph (g). E. Redesignating paragraphs (h) and (i) as paragraphs (g) and (h), respectively. F. Amending newly redesignated paragra ph (h)(2)(ii) by removi ng “paragraph (i)(2)(i) of this section” and adding in its pl ace “paragraph (h)(2)(i) of this section”. G. Amending newly redesignated paragraph (h )(2)(iii) by removing “p aragraph (i)(2)(ii) of this section” and adding in its pla ce “paragraph (h)(2)(i) of this section”.

The revisions and additions read as follows: §403.904 Reports of payments or other transf ers of value to covered recipients.

* * * * * (c) * * * (8) Related covered drug, device, biologica l or medical supply. Report the marketed name of the related covered drugs, devices, biologi cals, or medical supplies, and therapeutic areaCMS-1612-FC 1147

or product category unless the payment or other tran sfer of value is not related to a particular covered drug, device, biol ogical or medical supply. (i) For drugs and biologicals, if the marketed name has not yet been selected, applicable

manufacturers must indicate the name registered on clinicaltrials.gov. (ii) Applicable manufacturers may report the marketed name and therapeutic area or product category for payments or other transfers of value related to a non-covered drug, device, biological, or medical supply. (iii) Applicable manufacturers must indicate if the related drug, device, biological, or medical supply is covered or non-covered. (iv) Applicable manufacturers must indicate if the payment or other transfer of value is not related to any covered or non-covered dr ug, device, biological or medical supply.

* * * * * (d) * * * (3) Stock. (4) Stock option. (5) Any other ownership interest. (6) Dividend, profit or other return on investment.

* * * * * (f) * * * (1) * * * (iv) Name(s) of any related covered drugs , devices, biologicals, or medical supplies (subject to the requirements spec ified in paragraph (c)(8) of this section), for drugs and biologicals, the relevant Nationa l Drug Code(s), if any, for de vices and medical supplies and report a therapeutic area or product category if a marketed name is not available.CMS-1612-FC 1148

* * * * * §403.906 [Amended] 4. In §403.906, amend paragraph (b)(6) by re moving “§403.904(c) through (i)” and by adding in its place “§403.904(c) through (h).” 5. New subpart K is added to part 403 to read as follows: Subpart K--Access to Identifiable Data for th e Center for Medicare and Medicaid Models

Sec. 403.1100 Purpose and scope.

403.1105 Definitions.

403.1110 Evaluation of models. Subpart K--Access to Identifiable Data for the Center for Medicare and Medicaid Models §403.1100 Purpose and scope. The regulations in this subpart implement s ection 1115A of the Act. The intent of that

section is to enable CMS to test innovative payment and service deli very models to reduce program expenditures while preserving and/or enhancing the quality of care furnished to individuals under titles XVIII, XI X, and XXI of the Act. The Secretary is also required to

conduct an evaluation of each model tested. §403.1105 Definitions. For purposes of this subpart-- Applicable titles means Titles XVIII, XIX, or XXI of the Act. §403.1110 Evaluation of models. (a) Evaluation. The Secretary conducts an ev aluation of each model tested under section

1115A of the Act. Such evaluation must include an analysis of the following:CMS-1612-FC 1149

(1) The quality of care furnished under the m odel, including the measurement of patientlevel outcomes and patient-centeredness criteri a determined appropriate by the Secretary. (2) The changes in spending under the appl icable titles by reas on of the model. (b) Information. Any State or other entity participating in the testing of a model under

section 1115A of the Act must co llect and report such informati on, including “protected health

information” as that term is defined at 45 CF R 160.103, as the Secretary determines is necessary

to monitor and evaluate such model. Such data must be produced to the Secretary at the time

and in the form and manner specified by the Secretary.

PART 405--FEDERAL HEALTH INSU RANCE FOR THE AG ED AND DISABLED 6. The authority citation for part 40 5 continues to read as follows: Authority: Secs. 205(a), 1102, 1861, 1862(a), 1869, 1871, 1874, 1881, and 1886(k) of the Social Security Act (42 U.S. C. 405(a), 1302, 1395x, 1395y(a), 1395ff, 1395hh, 1395kk, 1395rr and 1395ww(k)), and sec. 353 of the P ublic Health Service Act (42 U.S.C. 263a). 7. Section 405.400 is amended by revising the definition of “Emergency care services” to

read as follows: §405.400 Definitions.

* * * * * Emergency care services means inpatient or outpatient hospital services that are necessary to prevent death or serious impairment of health and, because of the danger to life or health, require use of the most accessible hosp ital available and equipped to furnish those

services.

* * * * * §405.420 [Amended]CMS-1612-FC 1150

8. In §405.420, amend paragraph (e), by re moving the phrase “M edicare+Choice” and adding in its place the phrase “Medicare Advantage”. §405.425 [Amended] 9. In §405.425, amend paragraph (a) by removing the phrase “Medicare+Choice” and adding in its place the phrase “Medicare Advantage”. §405.450 [Amended] 10. In §405.450, amend paragraph (a) by rem oving the reference “§405.803” and adding in its place the reference “§498.3(b) of this ch apter” and amend paragraph (b) by removing the reference “§405.803” and addi ng in its place “§405.924”. §405.455 [Amended] 11. In §405.455, remove the phrase “Medicare+Choice” and add in its place the phrase “Medicare Advantage” wherever it appears. 12. Section 405.924 is amended by adding para graph (b)(15) to read as follows: §405.924 Actions that are initial determinations.

* * * * * (b) * * * (15) A claim not payable to a beneficiary for the services of a physician who has optedout. * * * * * 13. Section 405.2413 is amended by— A. Amending paragraph (a)(4 ) by removing “;” and by adding in its place “; and”. B. Revising paragraph (a)(5). C. Removing paragraph (a)(6).

The revision reads as follow: §405.2413 Services and supplies incident to a physician's services. (a) * * *CMS-1612-FC 1151

(5) Furnished under the direct supervision of a physician.

* * * * * 14. Section 405.2415 is amended by— A. Revising the section h eading and paragraph (a)(5). B. Removing paragraph (a)(6).

The revision reads as follows: §405.2415 Services and supplies incident to nurs e practitioner, physician assistant, or

certified nurse-midwife services. (a) * * * (5) Furnished under the direct supervision of a nurse practitioner, physician assistant, or

certified nurse- midwife.

* * * * * 15. Section 405.2452 is amended by— A. Amending paragraph (a)(4 ) by removing “;” and by adding in its place “; and”. B. Revising paragraph (a)(5). C. Removing paragraph (a)(6).

The revision reads as follows: §405.2452 Services and supplies incident to clinical psychologist and c linical social worker

services. (a) * * * (5) Furnished under the direct supervision of a clinical psychologist or clinical social

worker.

* * * * *

16. Section 405.2463 is revised to read as follows:CMS-1612-FC 1152

§405.2463 What constitutes a visit. (a) Visit--General. (1) For RHCs, a visit is either of the following: (i) Face-to-face encounter between a RH C patient and one of the following: (A) Physician. (B) Physician assistant. (C) Nurse practitioner. (D) Certified nurse midwife. (E) Visiting registered professiona l or licensed practical nurse. (G) Clinical psychologist. (H) Clinical social worker. (ii) Qualified transitional care management service. (2) For FQHCs, a visit is either of the following: (i) A visit as described in paragraph (a)(1)(i) or (ii) of this section. (ii) A face-to-face encounter between a patient and either of the following: (A) A qualified provider of me dical nutrition therapy servi ces as defined in part 410, subpart G, of this chapter. (B) A qualified provider of out patient diabetes self-manag ement training services as defined in part 410, subpart H, of this chapter. (b) Visit--Medical. (1) A medi cal visit is a face-to-face encounter between a RHC or FQHC patient and one of the following: (i) Physician. (ii) Physician assistant. (iii) Nurse practitioner. (iv) Certified nurse midwife.CMS-1612-FC 1153

(v) Visiting registered professiona l or licensed practical nurse. (2) A medical visit for a FQHC patient may be either of the following: (i) Medical nutrition therapy visit. (ii) Diabetes outpatient self-management training visit. (3) Visit--Mental health. A me ntal health visit is a face- to-face encounter between a RHC or FQHC patient and one of the following: (i) Clinical psychologist. (ii) Clinical social worker. (iii) Other RHC or FQHC practitioner, in accordance with paragr aph (b)(1) of this section, for mental health services. (c) Visit--Multiple. (1) For RHCs and FQHCs that are authorized to bill under the reasonable cost system, encounters with more than one health professional and multiple encounters with the same health professional th at take place on the same day and at a single location constitute a single visit, except when the patient— (i) Suffers an illness or injury subsequent to the first visit that requires additional diagnosis or treatment on the same day; (ii) Has a medical visit and a mental health visit on the same day; or (iii) Has an initial preventive physical exam visit and a separa te medical or mental health visit on the same day. (2) For RHCs and FQHCs that are authorized to bill under the reasonable cost system, Medicare pays RHCs and FQHCs fo r more than 1 visit per day when the conditions in paragraph (c)(1) of this s ection are met.CMS-1612-FC 1154

(3) For FQHCs that are authorized to bill und er the reasonable cost system, Medicare pays for more than 1 visit per day when a DSMT or MNT visit is furnished on the same day as a visit described in paragraph (c)( 1) of this section are met. (4) For FQHCs billing under the prospective payment system, Medicare pays for more than 1 visit per day when the patient— (i) Suffers an illness or injury subsequent to the first visit that requires additional diagnosis or treatment on the same day; or (ii) Has a medical visit and a ment al health visit on the same day. PART 410—SUPPLEMENTARY MEDICAL INSURANCE (SMI) BENEFITS 17. The authority citation for part 410 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. 18. Section 410.26 is amended by revising para graphs (b)(5) and (b)(6) to read as

follows: §410.26 Services and supplies incident to a physician's professional services:

Conditions.

* * * * * (b) * * * (5) In general, services and supplies must be furnished under the direct supervision of the physician (or other practitioner). Services and su pplies furnished incident to transitional care management and chronic care management servic es can be furnished under general supervision of the physician (or other practitioner) when these services or supplies are provided by clinical staff. The physician (or other practitioner) superv ising the auxiliary pers onnel need not be theCMS-1612-FC 1155

same physician (or other practitioner) upon whose prof essional service the in cident to service is

based. (6) Services and supplies must be furnis hed by the physician, pr actitioner with an incident to benefit, or auxiliary personnel.

* * * * * 19. Section 410.37 is amended by revising para graph (a)(1)(iii) to read as follows: §410.37 Colorectal cancer screening tests: Conditions for and limitations on coverage. (a) * * * (1) * * * (iii) Screening colonoscopies, including anesthesia furnis hed in conjunction with the

service.

* * * * * 20. Section 410.59 is amended by revising para graph (c)(1)(ii) to read as follows: §410.59 Outpatient occupational therapy services: Conditions.

* * * * * (c) * * * (1) * * * (ii) Engage in the private practice of o ccupational therapy on a regular basis as an individual, in one of the following practice types: a solo practice, partnership, or group practice; or as an employee of one of these.

* * * * * 21. Section 410.60 is amended by revising para graph (c)(1)(ii) to read as follows: §410.60 Outpatient physical therapy services: Conditions.

* * * * *CMS-1612-FC 1156

(c) * * * (1) * * * (ii) Engage in the private practice of physical therapy on a regular ba sis as an individual, in one of the following practice types: a solo pr actice, partnership, or gr oup practice; or as an employee of one of these.

* * * * * 22. Section 410.62 is amended by revising para graph (c)(1)(ii) to read as follows: §410.62 Outpatient speech-language patholog y services: Conditions and exclusions.

* * * * * (c) * * * (1) * * * (ii) Engage in the private practice of speech -language pathology on a regular basis as an individual, in one of the followi ng practice types: a solo practice, partnership, or group practice; or as an employee of one of these.

* * * * * 23. Section 410.78 is amended by revising paragr aph (b) introductory text and paragraph (f) to read as follows: §410.78 Telehealth services.

* * * * * (b) General rule

. Medicare Part B pays for covered telehealth services included on the telehealth list when furnished by an interactive telecommunications system if the following

conditions are met:

* * * * *CMS-1612-FC 1157

(f) Process for adding or deleting services

. Changes to the list of Medicare telehealth services are made through the annual physician f ee schedule rulemaking process. A list of the

services covered as telehealth services under this section is available on the CMS website.

PART 411—EXCLUSIONS FROM MEDICARE AND LIMITATIONS ON MEDICARE

PAYMENT 24. The authority citation for part 411 continues to read as follows: Authority : Secs. 1102, 1860D-1 through 1860D- 42, 1871, and 1877 of the Social Security Act (42 U.S.C. 1302, 1395w -101 through 1395w-152, 1395hh, and 1395nn). 25. Section 411.15 is amended by adding paragr aph (p)(2)(xvii) to read as follows: §411.15 Particular services excluded from coverage.

* * * * * (p) * * * (2) * * * (xvii) Those RHC and FQHC services th at are described in §405.2411(b)(2) of this chapter.

* * * * *

PART 412--PROSPECTIVE PAYMENT SYSTEMS FOR INPATIENT HOSPITAL

SERVICES 26. The authority citation for part 412 continues to read as follows: Authority : Secs. 1102 and 1871 of the Social Security Act (42 U.S.C. 1302 and 1395hh), sec. 124 of Pub. L. 106-113 (113 Stat. 1501A-332), sec. 1206 of Pub. L. 113-67, and

sec. 112 of Pub. L. 113-93. §412.64 [Amended]

27. In 412.64—CMS-1612-FC 1158

A. Amend paragraph (d)(4)(ii)(A) by removing the phrase “to April 1 of the year before the payment adjustment year” and adding in its place the phrase “to April 1 of the year before the payment adjustment year, or a later date specified by CMS”. B. Amend paragraph (d)(4)(ii)(A) by removi ng the phrase “by April 1 of the year before the applicable payment adjustment year” and addi ng in its place the phra se “by April 1 of the year before the applicable payment adjustme nt year, or a later date specified by CMS”. C. Amend paragraph (d)(4)(ii)(B)(1) by rem oving the phrase “April 1 of the year before the applicable payment adjustment year” and addi ng in its place the phrase “April 1 of the year before the applicable payment adjustment year, or a later date specified by CMS”. D. Amend paragraph (d)(4)(ii)(B)(2) by rem oving the phrase “April 1 of the year before the applicable payment adjustment year” and addi ng in its place the phrase “April 1 of the year before the applicable payment adjustment year, or a later date specified by CMS”.

PART 413--PRINCIPLES OF REASONAB LE COST REIMBURSEMENT; PAYMENT

FOR END-STAGE RENAL DISEASE SERVI CES; OPTIONAL PROSPECTIVELY

DETERMINED PAYMENT RATES FOR SKILLED NURSING FACILITY SERVICES 28. The authority citation for part 413 continues to read as follows: Authority: Secs. 1102, 1812(d), 1814(b), 1815, 1833(a) , (i), and (n), 1861(v), 1871, 1881, 1883 and 1886 of the Social Security Act (42 U.S.C. 1302, 1395d(d), 1395f(b), 1395g, 1395l(a), (i), and (n), 1395x( v), 1395hh, 1395rr, 1395tt, and 1395ww) ; and sec. 124 of Pub. L. 106-113 (113 Stat. 1501A-332), sec. 3201 of Pub. L. 112-96 (126 Stat. 156), and sec. 632 of Pub. L. 112-240 (126 Stat. 2354). § 413.70 [Amended] 29. Amend §413.70 by:CMS-1612-FC 1159

A. Amending paragraph (a)(6)( ii) introductory text by removi ng the phrase “no later than

November 30 after the close of the applicable EHR reporting peri od” and adding in its place the phrase “ no later than November 30 after the clos e of the applicable EHR reporting period, or a later date specified by CMS ”. B. Amending paragraph (a)(6)( ii)(A) by removing the phrase “to November 30 after the end of the payment adjustment year” and adding in its place the phrase “to November 30 after the end of the payment adjustment year , or a later date specified by CMS”.

PART 414—PAYMENT FOR PART B MEDI CAL AND OTHER HEALTH SERVICES 30. The authority citation for part 414 continues to read as follows: Authority: Secs. 1102, 1871, and 1881(b)(l) of the So cial Security Act (42 U.S.C. 1302, 1395hh, and 1395rr(b)(l)). 31. Section 414.24 is amended by— A. Revising the section headi ng, and paragraphs (a) and (b). B. Redesignating paragraph (c) as paragraph (d). C. Adding new paragraph (c).

The revisions and addition read as follows: §414.24 Publication of RVUs and direct PE inputs. (a) Definitions. For purposes of this section, the following definitions apply: Existing code means a code that is not a ne w code under paragraph (c )(2) of this section, and includes codes for which the descriptor is revised and codes that are combinations or subdivisions of previously existing codes.

New code means a code that describes a serv ice that was not prev iously described or valued under the PFS using any other c ode or combination of codes.CMS-1612-FC 1160

(b) Revisions of RVUs and Direct PE Inputs. For valuations for calendar year 2017 and beyond, CMS publishes, through notice and comment rulemaking in the Federal Register (including proposals in a proposed ru le), changes in RVUs or direct PE inputs for existing codes. (c) Establishing RVUs and Direct PE inputs for new codes. (1) General rule. CMS establishes RVUs a nd direct PE inputs for new codes in the manner described in paragra ph (b) of this section. (2) Exception for new codes for which CMS doe s not have sufficient information. When

CMS determines for a new code that it does not have sufficient information to include proposed RVUs or direct PE inputs in the proposed rule, but that it is in the public in terest for Medicare to use a new code during a payment year, CMS will publish in the Federal Register RVUs and direct PE inputs that are applicable on an interim basis subject to public comment. After considering public comments and other informati on on interim RVUs and PE inputs for the new code, CMS publishes in the Federal Register the final RVUs and PE inputs for the code.

* * * * * 32. Section 414.90 is amended by— A. In paragraph (b) by revising the definition of “Measures group”. B. In paragraphs (h)(5)(i)(B), (h)(5)(v), (j )(5)(i)(B) and (j)(5)(v) remove the phrase “CG CAHPS” and add in its place th e phrase “CAHPS for PQRS”. C. In paragraphs (h)(4)(v) and (j)(4)(vi ) remove the phrase “CAHPS” and add in its place the phrase “CAHPS for PQRS”. D. Redesignate paragraphs (j)(4) and (j )(5) as (j)(5) and (j)(6), respectively. E. Adding new paragraphs (j)( 4), (j)(7), (k)(4) and (m)(3). F. Revising paragraph (m)(1).

The revisions read as follows:CMS-1612-FC 1161

§414.90 Physician Quality Reporting System (PQRS).

* * * * * (b) * * * Measures group means a subset of six or more PQRS measures that have a particular

clinical condition or focus in common. The deno minator definition and coding of the measures group identifies the condition or focus that is sh ared across the measures within a particular

measures group. * * * * * (j) * * * (4) Satisfactory Reporting Criteria for Indivi dual Eligible Professi onals for the 2017 PQRS Payment Adjustment. An individual eligible pr ofessional who wishes to meet the criteria for satisfactory reporting for the 2017 PQRS payment adjustment must report information on PQRS quality measures identified by CMS in one of the following manners: (i) Via Claims. (A) For the 12-month 2017 PQRS payment adjustment reporting period

-- (1)(i) Report at least 9 measures, covering at least 3 of the NQS domains and report each measure for at least 50 percent of the eligible professional’s Medicare Part B FFS patients seen during the reporting period to which the measure a pplies. Of the 9 meas ures reported, if the eligible professional sees at l east 1 Medicare patient in a face -to-face encounter, the eligible professional must report on at least 1 measure contained in the cross-cutting measure set specified by CMS. If less than 9 measures appl y to the eligible profe ssional, report up to 8 measures and report each measure for at least 50 percent of the Medicare 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. (ii) [Reserved]CMS-1612-FC 1162

(ii) Via Qualified Registry. (A) For the 12-month 2017 PQRS payment adjustment reporting period

-- (1)(i) Report at least 9 measures, covering at least 3 of the NQS domains and report each measure for at least 50 percent of the eligible professional’s Medicare Part B FFS patients seen during the reporting period to which the measure a pplies. Of the 9 meas ures reported, if the eligible professional sees at l east 1 Medicare patient in a face -to-face encounter, the eligible professional must report on at least 1 measure contained in the cross-cutting measure set specified by CMS. If less than 9 measures appl y to the eligible profe ssional, report up to 8 measures and report each measure for at least 50 percent of the Medicare Part B FFS patients seen during the reportin g period to which the measure applies. (ii) Report at least 1 measures group and report each measures group for at least 20 patients, a majority of which much be Medicare Part B FFS patients. (2) Measures with a 0 percent performance rate or measures groups containing a measure with a 0 percent performan ce rate will not be counted. (iii) Via EHR Direct Product. For th e 12-month 2017 PQRS payment adjustment reporting period, report 9 measures covering at least 3 of the NQS domains. If an eligible professional's direct EHR product does not contain patient data for at least 9 measures covering at least 3 domains, then the eligible professi onal must report the measures for which there is Medicare patient data. An elig ible professional must report on at least 1 measure for which there is Medicare patient data. (iv) Via EHR Data Submission Vendor. For the 12-month 2017 PQRS payment adjustment reporting period, report 9 measures covering at least 3 of the NQS domains. If an eligible professional's EHR data submission vendor product does not contain patient data for at least 9 measures covering at least 3 domains, then the eligible professional must report theCMS-1612-FC 1163

measures for which there is Medicare patient data . An eligible professional must report on at

least 1 measure for which there is Medicare patient data.

* * * * * (7) Satisfactory reporting criteria for gr oup practices for the 2017 PQRS payment adjustment. A group practice who wishes to meet the criteria for satisfa ctory reporting for the 2017 PQRS payment adjustment must report info rmation on PQRS quality measures identified by CMS in one of the following manners: (i) Via the GPRO web interface. For th e 12-month 2017 PQRS payment adjustment reporting period, for a group practice of 25 to 99 e ligible professionals, report on all measures included in the web interface and populate data fi elds for the first 248 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 eligib le assigned beneficiaries is less than 248, then report on 100 percent of assigne d beneficiaries. A group prac tice must report on at least 1 measure for which there is Medicare patient data. (ii) Via Qualified Registry. For a group pract ice of 2 to 99 eligible professionals, for the 12-month 2017 PQRS payment adjustment reporti ng period, report at least 9 measures, covering at least 3 of the NQS domains and report each measure for at least 50 percent of the group practice's Medicare Part B FFS pa tients seen during the reporti ng period to which the measure applies; or if less than 9 m easures covering at least 3 NQS domains apply to the eligible professional, then the group practice must report up to 8 measures for which there is Medicare patient data 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 measur e applies. Of the measures reported, if any eligible professi onal in the group practice sees at least 1 Medicare patient in a face-to-face encounter, the group practice must re port on at least 1 measure contained in theCMS-1612-FC 1164

cross-cutting measure set specified by CMS. Measures with a 0 percent performance rate would not be counted; or (iii) Via EHR Direct Product. For a group pr actice of 2 to 99 eligible professionals, for the 12-month 2017 PQRS payment adjustment re porting period, report 9 measures covering at least 3 of the NQS domains. If a group practi ce's direct EHR product does not contain patient data for at least 9 measures covering at least 3 domains, then the group practice must report the measures for which there is Medicare patient data. A group practice must report on at least 1 measure for which there is Medicare patient data. (iv) Via EHR Data Submission Vendor. For a group practice of 2 to 99 eligible professionals, for the 12-month 2017 PQRS paym ent adjustment reporting period, report 9 measures covering at least 3 of the NQS domain s. If a group practice's EHR data submission vendor product does not contain patient data for at least 9 measures covering at least 3 domains, then the group practice must report the measures for which there is Medicare patient data. A group practice must report on at least 1 measur e for which there is Medicare patient data. (v) Via a Certified Survey Vendor in addi tion to a Qualified Registry. For a group practice of 2 or more eligible professionals , for the 12-month 2017 PQRS payment adjustment reporting period, report all CAH PS for PQRS survey measures via a CMS-certified survey vendor and report at least 6 addi tional measures covering at leas t 2 of the NQS domains using a qualified registry. If less than 6 measures a pply to the group practice, the group practice must report up to 5 measures. Of the additional measures that must be reported in conjunction with reporting the CAHPS for PQRS survey measures , if any eligible professional in the group practice sees at least 1 Medica re patient in a face-to-face en counter, the group practice must report on at least 1 measure in the cross- cutting measure set specified by CMS.CMS-1612-FC 1165

(vi) Via a Certified Survey Vendor in a ddition a Direct EHR Product or EHR Data Submission Vendor. For a group practice of 2 or more eligible professionals, for the 12-month 2017 PQRS payment adjustment reporting period, report all CAHPS for PQRS survey measures via a CMS-certified survey vendor and report at least 6 additional measures, outside of CAHPS for PQRS, covering at least 2 of the NQS domain s using the direct EHR product that is CEHRT or EHR data submission vendor product that is CEHRT. If less than 6 measures apply to the group practice, the group practice must report up to 5 measures. Of the additional measures that must be reported in conjunction with reporting the CAHPS for PQRS survey measures, the group practice must report on at least 1 measure for which there is Medicare patient data. (vii) Via a Certified Survey Vendor in additi on to the GPRO Web in terface. (A) For a group practice of 25 or more eligible profe ssionals, for the 12-month 2017 PQRS payment adjustment reporting period, report all CAHPS for PQRS survey measures via a CMS-certified survey vendor and report on all measures included in the GPRO web interface; AND populate data fields for the first 248 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 beneficiarie s is less than 248, then the group practice would report on 100 percent of assigned beneficiaries. A group prac tice must report on at least 1 measure for which there is Medicare patient data. (B) [Reserved] (k) * * * (4) Satisfactory participation criteria for individual elig ible professionals for the 2017 PQRS payment adjustment. An individual eligible professional who wishes to meet the criteria for satisfactory participation in a QCDR for the 2017 PQRS payment adjustment must report information on quality measures identified by the QCDR in one of the following manner:CMS-1612-FC 1166

(i) For the 12-month 2017 PQRS payment adju stment reporting period, report at least 9 measures available for reporting under a QCDR covering at least 3 of the NQS domains, and report each measure for at least 50 percent of th e eligible professional’s patients. Of these measures, report on at least 2 outcome measures, or, if 2 outcomes measures are not available, report on at least 2 outco me measures and at least 1 of the following types of measures – resource use, patient experience of care, e fficiency/appropriate use or patient safety. (ii) [Reserved]

* * * * * (m) * * * (1) To request an informal review for re porting periods that oc cur prior to 2014, an eligible professional or group pr actice must submit a request to CMS within 90 days of the release of the feedback reports. To request an informal review fo r reporting periods that occur in 2014 and subsequent years, an eligible professi onal or group practice must submit a request to CMS within 60 days of the release of the feedback reports. 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.

* * * * * (3) If, during the informal review process, CMS finds errors in data that was submitted by a third-party vendor on behalf of an eligible professional or group practice using either the qualified registry, EHR data submission vendor , or QCDR reporting mechanisms, CMS may

allow for the resubmission of data to correct these errors. (i) CMS will not allow resubmission of data submitted via claims, direct EHR, and the GPRO web interface reporting mechanisms.CMS-1612-FC 1167

(ii) CMS will only allow resubmission of data that was already previously submitted to

CMS. (iii) CMS will only accept data that was prev iously submitted for the reporting periods for which the corresponding inform al review period applies.

* * * * * §414.511 [Removed] 33. Section §414.511 is removed. 34. Section 414.610 is amended by revising para graphs (c)(1)(ii) in troductory text and (c)(5)(ii) to read as follows: §414.610 Basis of payment.

* * * * * (c) * * * (1) * * * (ii) For services furnished during th e period July 1, 2008 through March 31, 2015, ambulance services originating in:

* * * * * (5) * * * (ii) For services furnished during the period July 1, 2004 through March 31, 2015, the payment amount for the ground ambulance base rate is increased by 22.6 pe rcent where the point of pickup is in a rural area determined to be in the lowest 25 percent of rural 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 th e rural areas in the lowest quar tile of population compared to the average cost per trip for the ru ral areas in the highest quartil e of population. In making this estimate, CMS may use data provided by the GAO.CMS-1612-FC 1168

* * * * * 35. Section 414.1200 is amended by revising pa ragraphs (a) and (b)(5) to read as

follows: §414.1200 Basis and scope. (a) Basis

. This subpart implements section 1848( p) of the Act by establishing a payment modifier that provides for diffe rential payment starting in 201 5 to a group of physicians and starting in 2017 to a group and a solo practitioner under the Medicare Ph ysician Fee Schedule based on the quality of care furnished compar ed to cost during a performance period. (b) * * * (5) Additional measures for groups and solo practitioners.

* * * * * 36. Section 414.1205 is amended by— A. Revising the definitions of “Group of physicians” and “Value-based payment

modifier.” B. Adding the definition of “Solo practitioner” in al phabetical order.

The addition and revisions read as follows: §414.1205 Definitions.

* * * * * Group of physicians (Group) means a single Ta xpayer Identification Number (TIN) with 2 or more eligible professionals, as identifie d by their individual Na tional Provider Identifier (NPI), who have reassigned their Medicare billing ri ghts to the TIN.

* * * * *CMS-1612-FC 1169

Solo practitioner means a single Taxpayer Iden tification Number (TIN) with one eligible professional who is identified by an individual National Provider Identifier (NPI) billing under

the TIN.

* * * * * Value-based payment modifier means th e percentage as determined under §414.1270 by which amounts paid to a group or solo practit ioner under the Medicare Physician Fee Schedule

established under section 1848 of the Act are adjusted based upon a comparison of the quality of care furnished to cost as determined by this subpart. 37. Section 414.1210 is amended by— A. Adding paragraphs (a)(3), (a )(4), (b)(2), (b)(3), and (b)(4). B. Revising paragraph (c).

The additions and revision reads as follows: §414.1210 Application of the value-based payment modifier. (a) * * * (3) For the CY 2017 payment adjustment period and each subsequent calendar year payment adjustment period, to physicians in groups with 2 or more eligible professionals and to physicians who are solo practitioners base d on the performance period for the payment adjustment period as described at §414.1215. (4) For the CY 2018 payment adjustment period and each subsequent calendar year payment adjustment period, to nonphysician eligible professionals in groups with 2 or more eligible professionals and to nonphys ician eligible professionals w ho are solo practitioners based on the performance period for the payment ad justment period as described at §414.1215. (b) * * *CMS-1612-FC 1170

(2) Application of the value-ba sed payment modifier to participants in the Shared Savings Program. (i) For the CY 2017 payment adjustment period and each subsequent calendar year payment adjustment period, the value-based paymen t modifier is applicable to physicians in groups with 2 or more eligible professionals a nd to physicians who are solo practitioners that participate in an ACO under the Shared Savings Program during the performance period for the payment adjustment period as described at §414. 1215. The value-based payment modifier for a group or solo practitioner that participates in an ACO under th e Shared Savings Program during the performance period is determined based on paragraphs (b)(2)(i)(A ) through (D) of this

section. (A) The cost composite is classi fied as “average” under §414.1275(b). (B) The quality composite score is calcul ated under §414.1260(a) using quality data reported by the ACO for the performance peri od through the ACO GPRO web interface as required under § 425.504(a)(1) or another mechan ism specified by CMS and the ACO all-cause

readmission measure. (C) For the CY 2017 payment adjustment pe riod, the value-based payment modifier adjustment will be equal to the amount determined under § 414.1275 for the payment adjustment period, except that if the ACO doe s not successfully report quality da ta as described in paragraph (b)(2)(i)(B) of this sectio n for the performance period, such adjustment will be equal to – 4% for groups with 10 or more eligible professionals a nd equal to – 2% for groups with two to nine eligible professionals an d for solo practitioners. (D) The same value-based payment modifier ad justment will be applied in the payment adjustment period to all groups based on size as specified under § 414.1275 and solo practitioners that participated in the ACO during the performance period.CMS-1612-FC 1171

(ii) For the CY 2018 payment adjustment pe riod and each subsequent calendar year payment adjustment period, the value-based paym ent modifier is applicable to nonphysician eligible professionals in groups with 2 or more eligible professionals and to nonphysician eligible professionals who are so lo practitioners that particip ate in an ACO under the Shared Savings Program during the performance period fo r the payment adjustment period as described at §414.1215. The value-based payment modifier for nonphysician eligible professionals is determined in the same manner as for physicia ns as described under paragraphs (b)(2)(i)(A) through (D) of this section. (3) Application of the value- based payment modifier to participants in the Pioneer ACO Model and the Comprehensive Pr imary Care Initiative. (i) For the CY 2017 payment adjustment period, the value-based payment modifier is applicable to physicians in groups with 2 or mo re eligible professionals and to physicians who are solo practitioners that participate in the Pioneer ACO Model or the Comprehensive Primary Care (CPC) Initiative during the performance period for the payment adjustment period as described at §414.1215. For purposes of the valu e-based payment modifier, a group or solo practitioner is considered to be participating in the Pioneer ACO Model or CPC Initiative if at least one eligible professional bi lling under the TIN in the performa nce period is participating in

the Pioneer ACO Model or CPC In itiative in the performance pe riod. The value-based payment modifier for groups and solo practitioners that participate in th e Pioneer ACO Model or the CPC Initiative during the performance period is dete rmined based on paragraphs (b)(3)(i)(A) through (C) of this section. (A) The cost composite is classi fied as “average” under §414.1275(b). (B) The quality composite is classified as “average” under §414.1275(b).CMS-1612-FC 1172

(C) The same value-based payment modifier ad justment will be applied in the payment adjustment period to all groups based on size as specified under § 414.1275 and solo practitioners that partic ipated in the Pioneer ACO or CPC site during the performance period. (4) Application of the value-based payment modifier to participants in other similar

Innovation Center models or CMS initiatives. (i) For the CY 2017 payment adjustment period and each subsequent calendar year payment adjustment period, the value-based paymen t modifier is applicable to physicians in groups with 2 or more eligible professionals a nd to physicians who are solo practitioners that participate in other similar Innovation Center mo dels or CMS initiatives during the performance period for the payment adjustment period as de scribed at §414.1215. For purposes of the valuebased payment modifier, a group or solo practitioner is considered to be participating in a similar

Innovation Center model or CMS initiative if at least one eligible professional billing under the TIN in the performance period is participating in the model or initiative in the performance period. The value-based payment mo difier for groups and solo practit ioners that participate in a

similar Innovation Center model or CMS initia tive is determined based on paragraphs (b)(3)(i)(A) through (C) of this section. (ii) [Reserved] (c) Group size determination

. The list of groups of phys icians subject to the valuebased payment modifier for the CY 2015 paymen t adjustment period is based on a query of PECOS on October 15, 2013. For each subsequent ca lendar year payment adjustment period, the list of groups and solo practitione rs subject to the value-based payment modifier is based on a query of PECOS that occurs within 10 days of the close of the Physician Quality Reporting System group registration pro cess during the applicable perf ormance period described at §414.1215. Groups are removed from the PECOS-gene rated list if, based on a claims analysis,CMS-1612-FC 1173

the group did not have the required number of e ligible professionals, as defined in §414.1210(a), that submitted claims during the performance pe riod for the applicable calendar year payment adjustment period. Solo practitioners are remove d from the PECOS-generated list if, based on a claims analysis, the solo practitioner did not submit claims during the performance period for the applicable calendar year payment adjustment period. §414.1220 [Amended] 38. In §414.1220, remove the phrase “Groups of physicians” and add in its place the phrase “Solo practitioners and groups”.

39. Section 414.1225 is revised to read as follows: §414.1225 Alignment of Physician Quality Report ing System quality measures and quality measures for the value-based payment modifier. All of the quality measures for which solo pr actitioners and groups (o r individual eligible professionals within such groups) are eligible to report under the Phys ician Quality Reporting System in a given calendar year are used to ca lculate the value-based payment modifier for the applicable payment adjustment period, as defi ned in §414.1215, to the extent a solo practitioner or a group (or individual eligible professionals w ithin such group) submit data on such measures. 40. Section 414.1230 is amended by revising th e section heading and the introductory

text to read as follows: §414.1230 Additional measures for gro ups and solo practitioners. The value-based payment modifier includes the following additional quality measures (outcome measures) as a pplicable for all groups and solo prac titioners subject to the value-based payment modifier:

* * * * * §414.1235 [Amended]CMS-1612-FC 1174

41. In §414.1235, amend paragraph (a) introdu ctory text, by removing the phrase “of physicians subject” and add in its place the phrase “and solo practitioners subject”.

42. Section 414.1240 is revised to read as follows: §414.1240 Attribution for quality of care and cost measures. (a) Beneficiaries are attributed to groups and solo practitione rs subject to the value-based payment modifier using a method generally c onsistent with the method of assignment of beneficiaries under §425.402 of this chapter, for m easures other than the Medicare Spending per Beneficiary measure. (b) For the Medicare Spendi ng per Beneficiary (MSPB) measure, an MSPB episode is attributed to the group or the solo practitione r subject to the value-based payment modifier whose eligible professionals s ubmitted the plurality of claims (as measured by allowable charges) under the group's or solo practitione r’s TIN for Medicare Part B services, rendered during an inpatient hospitalization that is an index admission for the MSPB measure during the applicable performance period described at §414.1215. §414.1245 [Amended] 43. In §414.1245, amend the introductory text, by removing the phrase “of physicians subject” and add in its place the phra se “and solo practitioner subject”.

44. Section 414.1250 is revised to read as follows: §414.1250 Benchmarks for quality of care measures. (a) The benchmark for quality of care meas ures reported through the PQRS using the claims, registries, EHR, or web interface is the na tional mean for that measure's performance rate (regardless of the reporting mechan ism) during the year prior to the performance period. In calculating the national benchmark, solo practi tioners’ and groups’ (or individual eligible professionals’ within such groups) performa nce rates are weighted by the number ofCMS-1612-FC 1175

beneficiaries used to calculate the solo pract itioners’ or groups’ (or individual eligible professionals’ within such groups) performance rate. (b) The benchmark for each outcome measure under §414.1230, is the national mean for that measure’s performance rate during the year prior to the performance period. In calculating the national benchmark, solo practitioners’ and groups’ (or individual el igible professionals’ within such groups) performance rates are weight ed by the number of beneficiaries used to calculate the solo practitioners ’ or groups’ (or indivi dual eligible professi onals’ within such groups) performance rate. 45. Section 414.1255 is amended by revising paragraphs (b) and (c) to read as follows: §414.1255 Benchmarks for cost measures.

* * * * * (b) Beginning with the CY 2016 payment adju stment period, the cost measures of a group and solo practitioner subject to the value-based payment modi fier are adjusted to account for the group's and solo practitioner’s specialty mix, by computing the we ighted average of the national specialty-specific expected costs. Each national specialty-specif ic expected cost is weighted by the proportion of each specialty in th e group, the number of elig ible professionals of each specialty in the group, and the number of beneficiaries attributed to the group. (c) The national specialty-speci fic expected costs referenced in paragraph (b) of this section are derived by calculating, for each specialt y, the average cost of be neficiaries attributed to groups and solo practitioners that include that specialty. 46. Section 414.1265 is amended by revising the introductory text and paragraph (a) to

read as follows: §414.1265 Reliability of measures.CMS-1612-FC 1176

To calculate a composite score for a quality measure or a cost measure, a group or solo practitioner subject to the value- based payment modifier must ha ve 20 or more cases for that

measure. (a) In a performance period, if a group or so lo practitioner has fewer than 20 cases for a measure, that measure is excluded from its domai n and the remaining measures in the domain are given equal weight. (1) Starting with the CY 2017 payment adjustme nt period, the exception to this paragraph (a) is the all-cause hospital readmissions meas ure described at §414.1230(c). In a performance period, if a group or a solo pract itioner has fewer than 200 cases for this all-cause hospital readmissions measure, that measure is excluded fr om its domain and the remaining measures in the domain are given equal weight. (2) [Reserved]

* * * * *

47. Section 414.1270 is amended by revising paragraph (b)(4) and adding paragraph (c)

to read as follows: §414.1270 Determination and calculation of Valu e-Based Payment Modifier adjustments.

* * * * * (b) * * * (4) If at least fifty percent of the eligible professionals in the group meet the criteria as individuals to avoid the PQRS pa yment adjustment for CY 2016 as specified by CMS, and all of those eligible professionals use a qualified clinical data regist ry and CMS is unable to receive quality performance data for them, the quality co mposite score for such group will be classified as “average” under § 414.1275(b)(1).

* * * * *CMS-1612-FC 1177

(c) For the CY 2017 payment adjustment period: (1) A downward payment adjustment of

− 2.0 percent will be applied to a group with two to nine eligible professionals a nd a solo practitioner and a downwa rd payment adjustment of -4.0 percent will be applied to a group with 10 or more eligible professionals subject to the valuebased payment modifier if, during the appli cable performance period as defined in §414.1215, the following apply: (i) Such group does not self-nominate for th e PQRS GPRO and meet the criteria as a group to avoid the PQRS payment adjustment for CY 2017 as specified by CMS; and (ii) Fifty percent of the eligib le professionals in such group do not meet the criteria as individuals to avoid the PQRS payment adjustment for CY 2017 as specified by CMS; or (iii) Such solo practitioner does not meet the criteria as an individua l to avoid the PQRS payment adjustment for CY 2017 as specified by CMS. (2) For a group comprised of 10 or more elig ible professionals that is not included in paragraph (c)(1) of this section, the value-based payment modifier adjustment will be equal to the amount determined under §414.1275(c)(3)(i). (3) For a group comprised of between two to nine eligible professionals and a solo practitioner that are not included in paragraph (c)(1) of this section, the value-based payment modifier adjustment will be equal to the amount determined under §414.1275(c)(3)(ii). (4) If at least fifty percent of the eligible professionals in the group meet the criteria as individuals to avoid the PQRS pa yment adjustment for CY 2017 as specified by CMS, and all of those eligible professionals use a qualified clinical data regist ry and CMS is unable to receive quality performance data for them, the quality co mposite score for such group will be classified as “average” under § 414.1275(b)(1).CMS-1612-FC 1178

(5) A group and a solo practitioner subject to the value-based paym ent modifier will receive a cost composite score that is classified as “aver age” under §414.1275(b )(2) if such group and solo practitioner do not have at leas t one cost measure w ith at least 20 cases. 48. Section 414.1275 is amended by— A. Revising paragraph (a). B. Redesignating paragraphs (d) introductory text, (d)(1), and (d)(2) as paragraphs (d)(1) introductory text, (d)(1)(i), and (d)(1)(ii), respectively. C. Adding paragraphs (c)(3) and (d)(2).

The revision and additions read as follows: §414.1275 Value-based payment modifier qua lity-tiering scoring methodology. (a) The value-based payment modifier amount for a group and a solo practitioner subject to the value-based payment modifier is based up on a comparison of the composite of quality of care measures and a composite of cost measures.

* * * * * (c) * * * (3) The following value-based payment modi fier percentages a pply to the CY 2017 payment adjustment period: (i) For groups with 10 or more eligible professionals:

CY 2017 V ALUE -B ASED P AYMENT M ODIFIER A MOUNTS FOR THE Q UALITY -T IERING A PPROACH FOR G ROUPS WITH 10 OR MORE ELIGIBLE PROFESSIONALS Cost/Quality Low Quality Average Quality High Quality

Low Cost +0.0% +2.0x* +4.0x* Average Cost -2.0% +0.0% +2.0x* High Cost -4.0% -2.0% +0.0% *Groups eligible for an additional +1.0x if reporting Physician Quality Reporting System quality measures and average beneficiary risk score is in the top 25 percent of all beneficiary risk scores, wh ere ‘x’ represents the upward payment adjustment factor. (ii) For groups with two to nine eligible professiona ls and solo practitioners:CMS-1612-FC 1179

CY 2017 V ALUE -B ASED P AYMENT M ODIFIER A MOUNTS FOR THE Q UALITY -T IERING A PPROACH FOR G ROUPS WITH TWO TO NINE ELIG IBLE PROFESSIONALS AND SOLO PRACTITIONERS Cost/Quality Low Quality Average Quality High Quality

Low Cost +0.0% +1.0x* +2.0x* Average Cost +0.0% +0.0% +1.0x* High Cost +0.0% +0.0% +0.0% *Groups and solo practitioners eligible for an additiona l +1.0x if reporting Physician Quality Reporting System quality measures and average beneficiary risk score is in th e top 25 percent of all beneficiary risk scores, where ‘x’ represents the upward payment adjustment factor.

(d) * * * (2) Groups and solo practitioners subject to the value-based payment modifier that have an attributed beneficiary populati on with an average risk score in the top 25 percent of the risk

scores of beneficiaries nationw ide and for the CY 2017 payment ad justment period are subject to the quality-tiering approach, re ceive a greater upward paym ent adjustment as follows: (i) Classified as high quality/low cost receiv e an upward adjustment of +5x (rather than +4x) if the group has 10 or more eligible profe ssionals or +3x (rather than +2x) if a solo practitioner or the group has two to nine eligible professionals; and (ii) Classified as either high quality/average cost or averag e quality/low cost receive an upward adjustment of +3x (rather than +2x) if the group has 10 or more eligible professionals or +2x (rather than +1x) if a solo practitioner or the group has two to nine eligible professionals. §414.1285 [Amended] 49. In §414.1285, remove the phrase “of physicians may” and add in its place the phrase “and a solo practitioner may”.

PART 425--MEDICARE SHARED SAVINGS PROGRAM 50. The authority citation for part 425 continues to read as follows: Authority: Secs. 1102, 1106, 1871, and 1899 of the Social Security Act (42 U.S.C. 1302 and 1395hh).CMS-1612-FC 1180

51. 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

. All quality measures will be reported on Physician Compare in the same way as for the group practices that report under the Physician Quality Reporting System.

52. Section 425.502 is amended by--: A. In paragraph (a)(1), removing the phras e “of an ACO’s agreement, CMS” and adding in its place the phrase “of an AC O’s first agreement period, CMS” B. In paragraph (b)(2)(ii), removing the phrase “80.00 percent.” and adding in its place the phrase “80.00 percent, or when the 90 th percentile is equal to or greater than 95 percent.” C. Revising paragraph (a)(2). D. Adding paragraphs (a)(3), (a)(4), (b)(4), and (e)(4).

The revision and additions read as follows: §425.502 Calculating the ACO quality performance score. (a) * * * (2) During subsequent performance years of the ACO’s first agreement period, the quality performance standard will be phased in such that the ACO must continue to report all measures but the ACO will be assessed on performance based on the quality performance

benchmark and minimum attainment level of certain measures. (3) Under the quality performance standard for each performance year of an ACO’s subsequent agreement period, the ACO must conti nue to report on all measures but the ACO will be assessed on performance based on the quality performance benchmark and minimum

attainment level of certain measures.CMS-1612-FC 1181

(4) The quality performance standard for a newl y introduced measure is set at the level of complete and accurate reporting for the first tw o reporting periods for which reporting of the measure is required. For subsequent reporting pe riods, the quality performance standard for the measure will be assessed according to the phase-in schedule for the measure. (b) * * * (4)(i) CMS will update the quality performance benchmarks every 2 years. (ii) For newly introduced measur es that transition to pay fo r performance in the second year of the 2-year benchmarking cycle, the benchmark will be established for that year and updated along with the other measures at the st art of the next 2-year benchmarking cycle. (iii) CMS will use up to three years of data, as available, to set the benchmark for each quality measure.

* * * * * (e) * * * (4)(i) ACOs that demonstrate quality improve ment on established quality measures from year to year will be eligible for up to 4 bonus points per domain. (ii) Bonus points are awarded based on an AC O’s net improvement in measures within a domain, which is calculated by determining the total number of significantly improved measures and subtracting the total number of significantly declined measures. (iii) Up to four bonus points are awarded based on a comparison of the ACO’s net improvement in performance on the measures for the domain to the total number of individual

measures in the domain. (iv) When bonus points are added to points earned for the quality measures in the domain, the total points receive d for the domain may not exceed the maximum total points for

the domain in the absence of th e quality improvement measure.CMS-1612-FC 1182

(v) If an ACO renews its pa rticipation agreement for a subsequent agreement period, quality improvement will be measured based on a comparison between performance in the first year of the new agreement period and performance in the third year of the previous agreement period. 53. Section 425.506 is amended by revising th e section heading a nd adding paragraph (d) to read as follows: §425.506 Incorporating reporting requirements relat ed to adoption of Electronic health records technology.

* * * * * * (d) Eligible professionals pa rticipating in an ACO under the Shared Savings Program satisfy the CQM reporting component of mean ingful use for the Medicare EHR Incentive Program when the following occurs: (1) The eligible professional ex tracts data necessary for the ACO to satisfy the quality reporting requirements under this subpa rt from certified EHR technology. (2) The ACO reports the ACO GPRO m easures through a CMS web interface.

PART 489—PROVIDER AGREEMEN TS AND SUPPLIER APPROVAL 54. The authority citation for part 489 continues to read as follows: Authority : Secs. 1102, 1128I and 1871 of the Social Security Act (42 U.S.C. 1302, 1320a-7j, and 1395hh). 55. Section 489.20 is amended by adding para graph (s)(17) to read as follows: §489.20 Basic commitments.

* * * * * (s) * * * (17) Those RHC and FQHC services that are described in § 405.2411(b)(2) of thisCMS-1612-FC 1183

chapter.

* * * * *

PART 495--STANDARDS FOR THE ELECTRONIC HEALTH RECORD

TECHNOLOGY INCENTIVE PROGRAM 56. 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). §495.102 [Amended]

57. In 495.102— A. Amend paragraph (d)(4)(i) by removing the phrase in the fi rst sentence “to July 1 of the year preceding the payment adjustment year” and adding in its place the phrase “to July 1 of the year preceding the payment adjustment year, or a later date specified by CMS”. B. Amend paragraph (d)(4)(i) by removing th e phrase in the second sentence “no later than July 1 of the year before the applicable payment adjustment year” and adding in its place the phrase “no later than July 1 of the year before the applicable payment adjustment year, or a later date specified by CMS”. C. Amend paragraph (d)(4)(iii)(A) by re moving the phrase in the second sentence “no later than July 1 of the year before the appli cable payment adjustment year” and adding in its place the phrase “no later than July 1 of the year before the app licable payment adjustment year, or a later date specified by CMS”. D. Amend paragraph (d)(4)(ii i)(B) by removing the phrase in the second sentence “by July 1 of the year before the applicable paym ent adjustment year” and adding in its place the phrase “by July 1 of the year before the appli cable payment adjustment year, or a later date specified by CMS”.CMS-1612-FC 1184

E. Amend the introductory text of paragraph (d)(4)(iv) introductory text by removing the phrase “by July 1 of the year before the appli cable payment adjustment year” and adding in its place the phrase “by July 1 of the year before th e applicable payment adjustment year, or a later date specified by CMS”.

PART 498—APPEALS PROCEDURES FOR DETERMINATIONS THAT AFFECT

PARTICIPATION IN THE MEDICARE PROGRAM AND FOR D ETERMINATIONS

THAT AFFECT THE PARTICIPATION OF ICFs/IID AND CERTAIN NFs IN THE

MEDICAID PROGRAM 58. The authority citation for part 498 continues to read as follows: Authority: Secs. 1102, 1128I and 1871 of the Social Security Act (42 U.S.C. 1302, 1320a-7j, and 1395hh). 59. Section 498.3 is amended by adding para graph (b)(19) to read as follow: §498.3 Scope and applicability.

* * * * * (b) * * * (19) Whether a physician or practitioner has fa iled to properly opt-out, failed to maintain opt-out, failed to timely renew opt-o ut, failed to privately contract, or failed to properly terminate opt-out.

* * * * *CMS-1612-FC

Dated: October 22, 2014.

_______________________________ Marilyn Tavenner, Administrator,

Centers for Medicare & Medicaid Services.

Dated: October 28, 2014.

__________________________________ Sylvia M. Burwell, Secretary, Department of Health and Human Services.

BILLING CODE 4120-01-P

[FR Doc. 2014-26183 Filed 10/31/2014 at 4:15 pm; Publication Date: 11/13/2014]