[Federal Register Volume 79, Number 219 (Thursday, November 13, 2014)]
[Rules and Regulations]
[Pages 67548-68010]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2014-26183]



[[Page 67547]]

Vol. 79

Thursday,

No. 219

November 13, 2014

Part II





 Department of Health and Human Services





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 Centers for Medicare and Medicaid Services





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42 CFR Parts 403, 405, 410, et al.





 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; Final Rule

Federal Register / Vol. 79 , No. 219 / Thursday, November 13, 2014 / 
Rules and Regulations

[[Page 67548]]


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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.

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SUMMARY: This major final rule with comment period addresses changes to 
the physician fee schedule, and other Medicare Part B payment policies 
to ensure that our payment systems are updated to reflect changes in 
medical practice 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 final rule are effective 
on January 1, 2015, with the exception of amendments to parts 412, 413, 
and 495 which are effective October 31, 2014.
    Comment date: To be assured consideration, comments must be 
received 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 
requirements in Sec.  403.904(c)(8) is January 1, 2016.

ADDRESSES: In commenting, please refer to file code CMS-1612-FC. 
Because of staff and resource limitations, we cannot accept comments by 
facsimile (FAX) transmission.
    You may submit comments in one of four ways (please choose only one 
of the ways listed):
    1. Electronically. You may submit electronic comments on this 
regulation to www.regulations.gov. Follow the instructions for 
``submitting a comment.''
    2. By regular mail. You may mail written comments to the following 
address ONLY: Centers for Medicare & Medicaid Services, Department of 
Health and Human Services, Attention: CMS-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, you 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, 200 Independence Avenue SW., Washington, DC 
20201.
    (Because access to the interior of the Hubert 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 stamp-
in clock is available for persons wishing to retain a proof of filing 
by stamping 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, conscious 
sedation, or conversion factors.
    Kathy Kersell, (410) 786-2033, for issues related to direct 
practice expense inputs.
    Jessica Bruton, (410) 786-5991, for issues related to potentially 
misvalued services or work RVUs.
    Craig Dobyski, (410) 786-4584, for issues related 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 
extender provisions.
    Amy Gruber, (410) 786-1542, for issues related 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 related to Rural Health 
Clinics or Federally Qualified Health Centers.
    Renee Mentnech, (410) 786-6692, for issues related to access to 
identifiable data for the Centers for Medicare & Medicaid models.
    Marie Casey, (410) 786-7861 or Karen Reinhardt, (410) 786-0189, for 
issues related to local coverage determination process for clinical 
diagnostic laboratory tests.
    Frederick Grabau, (410) 786-0206, for issues related to private 
contracting/opt-out.
    David Walczak, (410) 786-4475, for issues related to payment policy 
for substitute physician billing arrangements (locum tenens).
    Melissa Heesters, (410) 786-0618, for issues related to reports of 
payments or other transfers of value to covered recipients.
    Alesia Hovatter, (410) 786-6861, for issues 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.
    Patrice Holtz, (410) 786-5663, for issues related to comprehensive 
primary care initiative.
    Terri Postma, (410) 786-4169, for issues related to Medicare Shared 
Savings Program.
    Kimberly Spalding Bush, (410) 786-3232, for issues 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, Medicare EHR Incentive 
Program (Medicare payment adjustments and hardship exceptions).

SUPPLEMENTARY INFORMATION:
    Inspection of Public Comments: All comments received before the 
close of

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the comment period are available for viewing by the public, including 
any personally 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 following Web site as soon as 
possible after they have been received: http://www.regulations.gov. 
Follow the search instructions on that Web site to view public 
comments.
    Comments received timely will also be available for public 
inspection as they are received, generally beginning approximately 3 
weeks 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 public comments, 
phone 1-800-743-3951.

Table of Contents

I. Executive Summary and Background
    A. Executive Summary
    B. Background
    C. Health Information Technology
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 Managing 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 for 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-Out
    H. Solicitation of Comments on the Payment Policy for Substitute 
Physician Billing Arrangements
    I. Reports of Payments or Other Transfers of Value to Covered 
Recipients
    J. Physician Compare Web Site
    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 Electronic Health Record (EHR) 
Incentive Program
IV. Collection of Information Requirements
V. Response to Comments
VI. Waiver of Proposed Rulemaking and Waiver of Delay in Effective 
Date
VII. Regulatory Impact Analysis
Regulations Text

Acronyms

    In addition, because of the many organizations and terms to which 
we refer by acronym in this final rule with comment period, we are 
listing these acronyms and their corresponding terms in alphabetical 
order below:

AAA Abdominal aortic aneurysms
ACO Accountable care organization
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 Health 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 Assessment 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 Medical 
Association. All rights reserved.)
CQM Clinical quality measure
CSW Clinical social worker
CT Computed tomography
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 area
IDTF Independent diagnostic testing facility
IPPS Inpatient Prospective Payment System
IQR Inpatient Quality Reporting
ISO Insurance service office
IWPUT Intensity of work 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 Patients and Providers Act (Pub. L. 
110-275)
MMA Medicare Prescription Drug, Improvement 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 Spending per Beneficiary
MSSP Medicare Shared Savings Program
MU Meaningful use
NCD National coverage determination
NCQDIS National Coalition of Quality 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 Reconciliation Act of 1989 (Pub. L. 101-239)
OBRA '90 Omnibus Budget Reconciliation 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 Medicare Act of 2014 (Pub. L. 113-93)
PC Professional component
PCIP Primary Care Incentive Payment

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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 approval
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 relative value scale
RFA Regulatory Flexibility Act
RHC Rural health clinic
RIA Regulatory impact analysis
RUC American Medical Association/Specialty 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 Number
USPSTF United States Preventive Services Task Force
VBP Value-based purchasing
VM Value-Based Payment Modifier

Addenda Available Only Through the Internet on the CMS Web Site

    The PFS Addenda along with other supporting documents and tables 
referenced in this final rule with comment period are available through 
the Internet on the CMS Web site at http://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/PhysicianFeeSched/PFS-Federal-Regulation-Notices.html. Click on the link on the left side of the 
screen titled, ``PFS Federal Regulations Notices'' for a chronological 
list of PFS Federal Register and other related documents. For the CY 
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 Web site 
identified above should contact <a href="/cdn-cgi/l/email-protection#71151e1f05105f19141f021e1f4031121c025f1919025f161e07"><span class="__cf_email__" data-cfemail="10747f7e64713e78757e637f7e2150737d633e7878633e777f66">[email protected]</span></a>.

CPT (Current Procedural Terminology) Copyright Notice

    Throughout this final rule with comment period, we use CPT codes 
and descriptions to refer to a variety of services. We note that CPT 
codes and descriptions are copyright 2013 American Medical Association. 
All Rights Reserved. CPT is a registered trademark of the American 
Medical Association (AMA). Applicable Federal Acquisition Regulations 
(FAR) and Defense Federal Acquisition Regulations (DFAR) apply.

I. Executive Summary and Background

A. Executive Summary

1. Purpose
    This major final rule with comment period revises payment 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.
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 the relative resources used in furnishing a service. 
The Act requires that RVUs be established for three categories of 
resources: Work, practice expense (PE); and malpractice (MP) expense; 
and, that we establish by regulation each year's payment amounts for 
all physicians' services, incorporating geographic adjustments to 
reflect the variations in the costs 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 and the relative value of services, 
as well as changes in the statute. In addition, this final rule with 
comment period includes discussions and proposals regarding:
    <bullet> Misvalued PFS Codes.
    <bullet> Telehealth Services.
    <bullet> Chronic Care Management Services.
    <bullet> Establishing Values for New, Revised, and Misvalued Codes.
    <bullet> Updating the Ambulance Fee Schedule regulations.
    <bullet> Changes in Geographic Area Delineations for Ambulance 
Payment.
    <bullet> Updating the--
    ++ Physician Compare Web site.
    ++ Physician Quality Reporting System.
    ++ Medicare Shared Savings Program.
    ++ Electronic Health Record (EHR) Incentive Program.
    <bullet> Value-Based Payment Modifier and the Physician Feedback 
Program.
3. Summary of Costs and Benefits
    The Act requires that annual adjustments to PFS RVUs may 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 adjustments to preserve budget neutrality. These 
adjustments can affect the distribution of Medicare expenditures across 
specialties. In addition, several proposed changes would affect the 
specialty distribution of Medicare expenditures. When considering the 
combined impact of work, 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 with 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.'' 
The system relies on national relative values that are established for 
work, PE, and MP, which are adjusted 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, enacted 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 
payment for physicians' services.
    We note that throughout this final rule with comment period, unless 
otherwise noted, the term ``practitioner'' is used to describe both 
physicians and nonphysician practitioners (NPPs) 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 extensive 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

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cooperative agreement with the Department of Health and Human Services 
(HHS). In constructing the code-specific vignettes 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 numerous physician specialty groups.
    As specified in section 1848(c)(1)(A) of the Act, the work 
component of physicians' services means the portion of the resources 
used in furnishing the service that reflects physician time and 
intensity. We establish work RVUs for new, revised and potentially 
misvalued codes based on our review of information that generally 
includes, but is not limited to, recommendations received from the 
American Medical Association/Specialty Society Relative Value Update 
Committee (RUC), the Health Care Professionals Advisory Committee 
(HCPAC), the Medicare Payment Advisory Commission (MedPAC), 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 health care 
professionals within CMS and the federal government. We also assess 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 RVUs
    Initially, only the work RVUs were resource-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 malpractice 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-based 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 resource-based system for PE over a 4-year period, 
payment rates were not fully based upon resource-based PE RVUs until CY 
2002. This resource-based system was based on two significant 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 greater 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 reflect all of the direct 
and indirect PEs involved in furnishing a service described by a 
particular HCPCS code. The difference, if any, in these PE RVUs 
generally results in a higher payment in the nonfacility setting 
because in the facility settings some costs are borne by the facility. 
Medicare's payment to the facility (such as the outpatient prospective 
payment system (OPPS) payment to the HOPD) would reflect costs 
typically incurred by the facility. Thus, payment associated with those 
facility resources is not made under the PFS.
    Section 212 of the Balanced Budget Refinement Act of 1999 (Pub. L. 
106-113, enacted on November 29, 1999) (BBRA) directed the Secretary of 
Health and Human Services (the Secretary) to establish a process under 
which 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 forth 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 final 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 comment period (71 FR 69624), we 
revised the methodology for calculating direct PE RVUs from the top-
down to the bottom-up methodology beginning in CY 2007. We adopted a 4-
year transition to the new PE RVUs. This transition was completed for 
CY 2010. In the CY 2010 PFS final rule with comment period, we updated 
the practice expense per hour (PE/HR) data that are used in the 
calculation 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 services furnished 
on or after CY 2000. The resource-based MP RVUs were implemented in the 
PFS final rule with comment period published November 2, 1999 (64 FR 
59380). The MP RVUs are based on commercial and physician-owned 
insurers' malpractice insurance premium 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 the Act requires that we review RVUs no 
less often than every 5 years. Prior to CY 2013, we conducted periodic 
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 
(PEAC), 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 comment period (76 FR 73057), we 
finalized a proposal to consolidate reviews of work and PE RVUs under 
section 1848(c)(2)(B) of the Act and reviews of potentially misvalued 
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.

[[Page 67552]]

    In addition to the five-year reviews, beginning for CY 2009, CMS, 
and the RUC have identified and reviewed a number of potentially 
misvalued codes on an annual basis based on various identification 
screens. This annual review of work and PE RVUs for potentially 
misvalued codes was supplemented by the amendments to section 1848 of 
the Act, as enacted by section 3134 of the Affordable Care Act, which 
requires the agency to periodically identify, review and adjust values 
for potentially misvalued codes.
e. Application of Budget Neutrality 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 the 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 physicians' 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 costs of furnishing the services. The GPCIs reflect the relative 
costs of physician work, PE, and MP in an area compared 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 through 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-adjusted increase in the Medicare Economic Index (MEI) and 
(b) the Update Adjustment Factor (UAF), which is calculated by taking 
into account the Medicare Sustainable Growth Rate (SGR), an annual 
growth rate intended to control growth in aggregate Medicare 
expenditures for physicians' services, and the allowed and actual 
expenditures for physicians' services. The formula for calculating the 
Medicare fee schedule payment amount for a given service and fee 
schedule area can be expressed as:

Payment = [(RVU work x GPCI work) + (RVU PE x GPCI PE) + (RVU MP x GPCI 
MP)] x CF.
3. Separate Fee Schedule Methodology for Anesthesia Services
    Section 1848(b)(2)(B) of the Act specifies that the fee schedule 
amounts for anesthesia services are to be based on a uniform relative 
value guide, with appropriate adjustment of an anesthesia conversion 
factor, in a manner to assure that fee schedule amounts for anesthesia 
services are consistent with those for other services of comparable 
value. Therefore, there is a separate fee schedule methodology for 
anesthesia services. Specifically, we establish a separate conversion 
factor for anesthesia services and we utilize the uniform relative 
value guide, or base units, as well as time units, to calculate the fee 
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 
policies. It also finalized many of the CY 2013 interim final RVUs and 
established interim final RVUs for new 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, enacted 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 
percent; 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.
    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 comment 
period (78 FR 74230) was revised to $35.8228 for services furnished on 
or after January 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 
several provisions of Medicare law that would have otherwise expired on 
December 31, 2013. The PAMA extended these same provisions further 
through March 31, 2015. A list of these provisions follows.

<bullet> The 1.0 floor on the work geographic practice cost index
<bullet> The exceptions process for outpatient therapy caps
<bullet> The manual medical review process for therapy services
<bullet> The application of the therapy caps and related provisions to 
services furnished in HOPDs

    In addition, section 220 of the PAMA included several provisions 
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 new subparagraph (M) provides that the Secretary 
may collect or obtain information from any eligible 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 include the time 
involved in furnishing services; the amounts, types and prices of 
practice expense inputs; overhead and accounting information for 
practices of physicians and other suppliers, and any other elements 
that would improve the valuation of services under the PFS. This 
information may be collected or obtained through surveys of physicians 
or other suppliers, providers of services, manufacturers, and vendors; 
surgical logs, billing systems, or other practice or facility records; 
EHRs; and any other mechanism determined appropriate by the Secretary. 
If we use this information, we are required to disclose the source and 
use of the information in rulemaking, and to make available aggregated 
information that does not disclose individual eligible professionals, 
group practices, or information obtained pursuant to a nondisclosure 
agreement. Beginning with fiscal year 2014, the Secretary may 
compensate eligible professionals for submission of data.

[[Page 67553]]

    Section 220(c) of the PAMA amended section 1848(c)(2)(K)(ii) of the 
Act to expand the categories of services that the Secretary is directed 
to examine for the purpose of identifying potentially misvalued codes. 
The nine new categories are as follows:
    <bullet> Codes that account for the majority of spending under the 
PFS.
    <bullet> Codes for services that have experienced a substantial 
change in the hospital length of stay or procedure time.
    <bullet> Codes for which there may be a change in the typical site 
of service since the code was last valued.
    <bullet> Codes for which there is a significant difference in 
payment for the same service between different sites of service.
    <bullet> Codes for which there may be anomalies in relative values 
within a family of codes.
    <bullet> Codes for services where there may be efficiencies when a 
service is furnished at the same time as other services.
    <bullet> Codes with high intra-service work per unit of time.
    <bullet> Codes with high PE RVUs.
    <bullet> Codes with high cost supplies.

(See section II.B. of this final rule with comment 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 advanced imaging procedures. The policy reduces the amount 
paid for the professional component when two advanced imaging 
procedures are furnished in the same session. The policy was effective 
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 provisions 
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 fee schedule for the year. If the net reduction 
in expenditures for the year is equal to or greater than the target for 
the year, the funds shall be redistributed in a budget-neutral 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 whether the target 
has or has not been met. The legislation includes an exemption from 
budget neutrality of reduced expenditures 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 percent for potentially misvalued 
codes that do not involve coding changes, and certain adjustments to 
the fee schedule 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 physicians' services for CY 
2015, as required by section 1848(d)(1)(E) of the Act. The actual 
values used to compute physician payments for CY 2015 will be based on 
later data and are scheduled to be published 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 Services (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 August 2013 
Statement, ``Principles and Strategies for Accelerating Health 
Information Exchange,'' see http://www.healthit.gov/sites/default/files/acceleratinghieprinciples_strategy.pdf) HHS is committed to 
accelerating health information exchange (HIE) through the use of safe, 
interoperable health information technology (health IT), including 
electronic health records (EHRs), across the broader care continuum 
through a number of initiatives: (1) Alignment of incentives and 
payment adjustments to encourage provider adoption and optimization of 
health IT and HIE services through Medicare and Medicaid payment 
policies; (2) adoption of common standards and certification 
requirements for interoperable HIT; (3) support 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 
hospitals eligible for the Medicare and Medicaid EHR Incentive Programs 
and those who are not eligible for the EHR Incentive Programs, and are 
designed to improve care delivery and coordination across the entire 
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 structure, ONC expressed in the 2014 Edition Release 2 
final rule (79 FR 54472-73) an intent to propose future changes to the 
ONC HIT Certification Program that would permit more efficient 
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 
efficiently help all providers improve internal care delivery 
practices, support management of patient care across the continuum, and 
support the reporting of electronically specified clinical quality 
measures (eCQMs).

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 the resources used in 
furnishing a service that reflects the general categories of physician 
and practitioner expenses, such as office rent and personnel wages, but 
excluding malpractice expenses, as specified in section 1848(c)(1)(B) 
of the Act. As required by section 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 considering the direct and indirect 
practice 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 sections that follow provide more 
detailed information about the methodology for translating 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 through 61748) for a more detailed explanation of 
the PE methodology.

[[Page 67554]]

2. Practice Expense Methodology
a. Direct Practice Expense
    We determine the direct PE for a specific service by adding the 
costs of the direct resources (that is, the clinical staff, medical 
supplies, and medical equipment) typically involved with furnishing 
that service. The costs of the resources are calculated using the 
refined direct PE inputs assigned to each CPT code in our PE database, 
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 direct PE methodology, including 
examples, we refer readers to the Five-Year Review 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 Expense Per Hour Data
    We use survey data on indirect PEs incurred 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 practitioners (NPPs) paid under the PFS using a survey 
instrument and methods highly consistent 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 available. 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 survey. 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 2013 forward are developed based entirely on the PPIS 
data, except as noted in this section.
    Section 1848(c)(2)(H)(i) of the Act requires us to use the medical 
oncology supplemental survey data submitted in 2003 for oncology drug 
administration services. Therefore, the PE/HR for medical oncology, 
hematology, and hematology/oncology 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 beginning in CY 
2005. Supplemental survey data from the National Coalition of Quality 
Diagnostic Imaging Services (NCQDIS), representing independent 
diagnostic testing facilities (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 developed from their supplemental survey data.
    Consistent with our past practice, the previous indirect 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 reproductive 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 Medicare-recognized specialty 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 participate in the PPIS. However, 
beginning in CY 2010 we changed the PE/HR crosswalk for portable x-ray 
suppliers from radiology to IDTF, a more appropriate crosswalk because 
these specialties are more similar to each other for work time.
    For registered dietician services, the resource-based PE RVUs have 
been calculated in accordance with the final policy that 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 the 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 relationship 
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 service has a direct cost sum of $200, the direct 
portion of the PE RVUs of the first service would be twice as much as 
the direct portion of the PE RVUs for the second service.
(2) Indirect Costs
    Section II.A.2.b. of this final rule with comment period describes 
the current data sources for specialty-specific indirect costs used in 
our PE calculations. We allocated the indirect costs to the code level 
on the basis of the direct costs specifically associated with a code 
and the greater of either the clinical labor costs or the physician 
work RVUs. We also incorporated the survey data described earlier in 
the PE/HR discussion. The general approach to developing the indirect 
portion of the PE RVUs is as follows:
    <bullet> For a given service, we use the direct 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 RVUs for a given service is 2.00 and direct costs, on 
average, represented 25 percent of total costs for the specialties that 
furnished the service, the initial indirect allocator 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

[[Page 67555]]

a total PE RVUs of 8.00 (2.00 is 25 percent of 8.00 and 6.00 is 75 
percent of 8.00).
    <bullet> 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 RVUs are greater than the 1.50 
clinical labor portion) to the initial indirect allocator of 6.00 to 
get an indirect allocator of 10.00. In the absence of any further use 
of the survey 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 these indirect cost allocators. For 
example, if one service had an indirect cost allocator of 10.00 and 
another service had an indirect cost allocator of 5.00, the indirect 
portion of the PE RVUs of the first service would be twice as great as 
the indirect portion of the PE RVUs for the second service.
    <bullet> Next, we incorporate the specialty-specific indirect PE/HR 
data into the calculation. In our example, if, based on the survey 
data, the average indirect cost of the specialties furnishing the first 
service with an allocator of 10.00 was half of the average indirect 
cost of the specialties furnishing the second service with 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 setting, we establish two PE 
RVUs: Facility and nonfacility. The methodology for calculating PE RVUs 
is the same for both the facility and nonfacility RVUs, but is applied 
independently to yield two separate PE RVUs. Because in calculating the 
PE RVUs for services furnished 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 
generally lower than the nonfacility PE RVUs. Medicare makes a separate 
payment to the facility for its costs of furnishing a service.
e. Services With Technical Components (TCs) and Professional Components 
(PCs)
    Diagnostic services are generally comprised of two components: A 
professional component (PC); and a technical component (TC). The PC and 
TC may be furnished independently or by different providers, or they 
may be furnished together as a ``global'' service. When services have 
separately billable PC and TC components, the payment for the global 
service equals the sum 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; that 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 Methodology
    For a more detailed description of the 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 setup 
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 inputs for each service. Apply 
a scaling adjustment to the direct inputs.
    Step 2: Calculate the aggregate pool of direct 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 survey data used for calculating the PE/HR by specialty.
    Step 3: Calculate the aggregate pool of direct 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 and Step 3, calculate a direct 
PE scaling adjustment to ensure that the aggregate pool of direct PE 
costs calculated 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 each service (as calculated in Step 1).
    Step 5: Convert the results of Step 4 to an RVU scale for each 
service. To do this, divide the results of Step 4 by the CF. Note that 
the actual value of the CF used in this calculation does not influence 
the final direct 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 direct cost PE RVUs since 
changes in the CFs and changes in the associated direct scaling factors 
offset one another.
(3) Create the Indirect Cost PE RVUs
    Create indirect allocators.
    Step 6: Based on the survey data, calculate direct and indirect PE 
percentages for each physician specialty.
    Step 7: Calculate direct and indirect PE percentages at the service 
level by taking a weighted average of the results of Step 6 for the 
specialties that furnish the service. Note that for services with TCs 
and PCs, the direct and indirect percentages for a given service do not 
vary by the PC, TC, and global service.
    Step 8: Calculate the service level allocators 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 
clinical PE RVUs; and the work RVUs.
    For most services the indirect allocator is: Indirect PE percentage 
* (direct PE RVUs/direct percentage) + work RVUs.
    There are two situations where this formula is modified:
    <bullet> 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.
    <bullet> If the clinical labor PE RVUs exceed the work RVUs (and 
the service is not a global service), then the indirect allocator is: 
Indirect PE percentage (direct PE RVUs/direct percentage) + clinical 
labor PE RVUs.

    (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 
recognize 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 clinical 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, the formulas 
were divided into two parts for each service.
    <bullet> The first part does not vary by service and is the 
indirect percentage (direct PE RVUs/direct percentage).
    <bullet> 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 described 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

[[Page 67556]]

the current aggregate pool of PE RVUs by the average indirect PE 
percentage from the survey data.
    Step 10: Calculate an aggregate pool of indirect PE RVUs for all 
PFS services by adding the product of the indirect PE allocators 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 indirect allocation does 
not exceed the available aggregate indirect PE RVUs and apply it to 
indirect allocators calculated in Step 8.
    Calculate the indirect practice cost index.
    Step 12: Using the results of Step 11, calculate aggregate pools of 
specialty-specific adjusted indirect PE allocators for all PFS services 
for a specialty by adding the product of the adjusted indirect PE 
allocator for each service and the utilization data for that service.
    Step 13: Using the specialty-specific indirect PE/HR data, 
calculate specialty-specific aggregate pools of indirect PE for all PFS 
services for that specialty by adding the product of the indirect PE/HR 
for the specialty, the work time for the service, and the specialty's 
utilization for the service across all services furnished by the 
specialty.
    Step 14: Using the results of Step 12 and Step 13, calculate the 
specialty-specific indirect PE scaling factors.
    Step 15: Using the results of Step 14, calculate an indirect 
practice cost index at the specialty level by dividing each specialty-
specific indirect scaling factor by the average indirect scaling factor 
for the entire PFS.
    Step 16: Calculate the indirect practice cost index at the service 
level to ensure the capture of all indirect costs. Calculate a weighted 
average of the practice cost index values for the specialties that 
furnish the service. (Note: For services with TCs and PCs, we calculate 
the indirect practice cost index across the global service, PCs, and 
TCs. Under this method, the indirect practice cost index for a given 
service (for example, echocardiogram) does not vary by the PC, TC, and 
global service.)
    Step 17: Apply the service level indirect practice cost index 
calculated 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 neutrality (BN) adjustment. 
The final PE BN adjustment is calculated by comparing the results 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 note that all specialties 
are included for purposes of calculating the final BN adjustment. (See 
``Specialties excluded from ratesetting calculation'' later in this 
section.)
(5) Setup File Information
    <bullet> Specialties excluded from ratesetting calculation: For the 
purposes of calculating the PE RVUs, we exclude certain specialties, 
such as certain nonphysician practitioners paid at a percentage of the 
PFS and low-volume specialties, from the calculation. These specialties 
are included for the purposes of calculating the BN adjustment. They 
are displayed in Table 1.

       Table 1--Specialties Excluded From Ratesetting Calculation
------------------------------------------------------------------------
    Specialty code                    Specialty description
------------------------------------------------------------------------
49....................  Ambulatory surgical center.
50....................  Nurse practitioner.
51....................  Medical supply company with certified orthotist.
52....................  Medical supply company with certified
                         prosthetist.
53....................  Medical supply company with certified
                         prosthetist[dash]orthotist.
54....................  Medical supply company not included in 51, 52,
                         or 53.
55....................  Individual certified orthotist.
56....................  Individual certified prosthetist.
57....................  Individual certified prosthetist[dash]orthotist.
58....................  Medical supply company with registered
                         pharmacist.
59....................  Ambulance service supplier, e.g., private
                         ambulance companies, funeral homes, etc.
60....................  Public health or welfare agencies.
61....................  Voluntary health or charitable agencies.
73....................  Mass immunization roster biller.
74....................  Radiation therapy centers.
87....................  All other suppliers (e.g., drug and department
                         stores).
88....................  Unknown supplier/provider specialty.
89....................  Certified clinical nurse specialist.
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.
------------------------------------------------------------------------

    <bullet> Crosswalk certain low volume physician specialties: 
Crosswalk the utilization of certain specialties with relatively low 
PFS utilization to the associated specialties.
    <bullet> Physical therapy utilization: Crosswalk the utilization 
associated

[[Page 67557]]

with all physical therapy services to the specialty of physical 
therapy.
    <bullet> Identify professional and technical services not 
identified under the usual TC and 26 modifiers: Flag the services that 
are PC and TC services, but do not use TC and 26 modifiers (for 
example, electrocardiograms). This flag associates the PC and TC with 
the associated global code for use in creating the indirect PE RVUs. 
For example, the professional service, CPT code 93010 
(Electrocardiogram, routine ECG with at least 12 leads; interpretation 
and report only), is associated with the global service, CPT code 93000 
(Electrocardiogram, routine ECG with at least 12 leads; with 
interpretation and report).
    <bullet> Payment modifiers: Payment modifiers are accounted for in 
the creation of the file consistent with current payment policy as 
implemented in claims processing. For example, services billed with the 
assistant at surgery modifier are paid 16 percent of the PFS amount for 
that service; therefore, the utilization file is modified to only 
account for 16 percent of any service that contains the assistant at 
surgery modifier. Similarly, for those services to which volume 
adjustments are made to account for the payment 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 intraoperative 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 accordingly. Table 2 details the manner in which the 
modifiers are applied.

                         Table 2--Application of Payment Modifiers to Utilization Files
----------------------------------------------------------------------------------------------------------------
           Modifier                    Description              Volume adjustment            Time adjustment
----------------------------------------------------------------------------------------------------------------
80,81,82......................  Assistant at Surgery....  16%..........................  Intraoperative portion.
AS............................  Assistant at Surgery--    14% (85% * 16%)..............  Intraoperative portion.
                                 Physician Assistant.
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  Preoperative +
                                                           Percentages on the payment     Intraoperative
                                                           files used by Medicare         portion.
                                                           contractors to process
                                                           Medicare claims.
55............................  Postoperative Care only.  Postoperative Percentage on    Postoperative portion.
                                                           the payment files used by
                                                           Medicare contractors to
                                                           process Medicare claims.
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 
rules and multiple procedure payment reductions (MPPR). We note that 
section 1848(c)(2)(B)(v) of the Act exempts certain reduced payments 
for multiple imaging procedures and multiple therapy 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 cases since that is the 
only situation where time units are duplicative.
    <bullet> Work RVUs: The setup file contains the 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)[caret] life of equipment)))) + maintenance)
Where:

minutes per year = maximum minutes per year 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 the particular piece of 
equipment.
maintenance = factor for maintenance; 0.05.
interest rate = variable, see discussion below.

    Usage: We currently use an equipment utilization rate assumption of 
50 percent for most equipment, with the exception of expensive 
diagnostic imaging equipment, for which we use a 90 percent assumption 
as required by Section 1848(b)(4)(C) of the Act.
    Maintenance: This factor for maintenance was proposed and finalized 
during rulemaking for CY 1998 PFS (62 FR 33164). Several stakeholders 
have 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 data from informal surveys constitutes reliable data. 
Rather than assertions that a particular maintenance rate is typical, 
multiple invoices 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 
adjustments to our methodology to accommodate variable maintenance 
costs.
    Per-use Equipment Costs: Several stakeholders 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 adjusting 
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 and other per-use equipment costs into our 
methodology, and received several comments that addressed how we should 
reclassify the anomalous supply inputs removed from the direct PE 
database. We will consider these comments in future rulemaking, 
including 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

[[Page 67558]]

developing an equipment cost per minute calculation. The interest rate 
was based on the Small Business Administration (SBA) maximum interest 
rates for different categories of loan size (equipment cost) and 
maturity (useful life). The interest rates are listed in Table 3. (See 
77 FR 68902 for a thorough discussion of this issue.)

                   Table 3--SBA Maximum Interest Rates
------------------------------------------------------------------------
                                                                Interest
                Price                        Useful life       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
------------------------------------------------------------------------


[[Page 67559]]


                                                              Table 4--Calculation of PE RVUS Under Methodology for Selected Codes
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                                            99213      33533                                       93000      93005      93010
                                                                                                            Office     CABG,      71020     71020-TC   71020-26     ECG,       ECG,       ECG,
       Factor (CF) (2nd part)                   Step                   Source               Formula         visit,   arterial,   Chest x-   Chest x-   Chest x-  Complete,   Tracing     Report
                                                                                                           est non-    single    ray non-  ray, non-  ray, non-     non-       non-       non-
                                                                                                           facility   facility   facility   facility   facility   facility   facility   facility
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
(1) Labor cost (Lab)................  Step 1.................  AMA...................  .................      13.32      77.52       5.74       5.74  .........       5.10       5.10  .........
(2) Supply cost (Sup)...............  Step 1.................  AMA...................  .................       2.98       7.34       0.53       0.53  .........       1.19       1.19  .........
(3) Equipment cost (Eqp)............  Step 1.................  AMA...................  .................       0.17       0.58       6.92       6.92  .........       0.09       0.09  .........
(4) Direct cost (Dir)...............  Step 1.................  ......................       =(1)+(2)+(3)      16.48      85.45      13.19      13.19  .........       6.38       6.38  .........
(5) Direct adjustment (Dir. Adj.)...  Steps 2-4..............  See footnote*.........  .................     0.5898     0.5898     0.5898     0.5898     0.5898     0.5898     0.5898     0.5898
(6) Adjusted Labor..................  Steps 2-4..............  =Labor * Dir Adj......           =(1)*(5)       7.86      45.72       3.39       3.39  .........       3.01       3.01  .........
(7) Adjusted Supplies...............  Steps 2-4..............  =Eqp * Dir Adj........           =(2)*(5)       1.76       4.33       0.31       0.31  .........       0.70       0.70  .........
(8) Adjusted Equipment..............  Steps 2-4..............  =Sup * Dir Adj........           =(3)*(5)       0.10       0.34       4.08       4.08  .........       0.05       0.05  .........
(9) Adjusted Direct.................  Steps 2-4..............  ......................       =(6)+(7)+(8)       9.72      50.40       7.78       7.78  .........       3.77       3.77  .........
(10) Conversion Factor (CF).........  Step 5.................  PFS...................  .................      35.82      35.82      35.82      35.82      35.82      35.82      35.82      35.82
(11) Adj. labor cost converted-.....  Step 5.................  =(Lab * Dir Adj)/CF...          =(6)/(10)       0.22       1.28       0.09       0.09  .........       0.08       0.08  .........
(12) Adj. supply cost converted.....  Step 5.................  =(Sup * Dir Adj)/CF...          =(7)/(10)       0.05       0.12       0.01       0.01  .........       0.02       0.02  .........
(13) Adj. equipment cost converted..  Step 5.................  =(Eqp * Dir Adj)/CF...          =(8)/(10)  .........       0.01       0.11       0.11  .........  .........  .........  .........
(14) Adj. direct cost converted.....  Step 5.................  ......................    =(11)+(12)+(13)       0.27       1.41       0.22       0.22  .........       0.11       0.11  .........
(15) Work RVU.......................  Setup File.............  PFS...................  .................       0.97      33.75       0.22  .........       0.22       0.17  .........       0.17
(16) Dir--pct.......................  Steps 6,7..............  Surveys...............  .................       0.25       0.17       0.29       0.29       0.29       0.29       0.29       0.29
(17) Ind--pct.......................  Steps 6,7..............  Surveys...............  .................       0.75       0.83       0.71       0.71       0.71       0.71       0.71       0.71
(18) Ind. Alloc. Formula (1st part).  Step 8.................  See Step 8............  .................     ((14)/     ((14)/     ((14)/     ((14)/     ((14)/     ((14)/     ((14)/     ((14)/
                                                                                                          (16)*(17)  (16)*(17)  (16)*(17)  (16)*(17)  (16)*(17)  (16)*(17)  (16)*(17)  (16)*(17)
(19) Ind. Alloc.(1st part)..........  Step 8.................  ......................             See 18       0.82       6.67       0.53       0.53  .........       0.26       0.26  .........
(20) Ind. Alloc. Formula (2nd part).  Step 8.................  See Step 8............  .................       (15)       (15)    (15+11)       (11)       (15)    (15+11)       (11)       (15)
(21) Ind. Alloc.(2nd part)..........  Step 8.................  ......................             See 20       0.97      33.75       0.31       0.09       0.22       0.25       0.08       0.17
(22) Indirect Allocator (1st + 2nd).  Step 8.................  ......................         =(19)+(21)       1.79      40.42       0.84       0.62       0.22       0.51       0.34       0.17
(23) Indirect Adjustment (Ind. Adj.)  Steps 9-11.............  See Footnote**........  .................     0.3813     0.3813     0.3813     0.3813     0.3813     0.3813     0.3813     0.3813
(24) Adjusted Indirect Allocator....  Steps 9-11.............  =Ind Alloc * Ind Adj..  .................       0.68      15.41       0.32       0.24       0.08       0.20       0.13       0.06
(25) Ind. Practice Cost Index (IPCI)  Steps 12-16............  ......................  .................       1.07       0.75       0.99       0.99       0.99       0.91       0.91       0.91
(26) Adjusted Indirect..............  Step 17................  = Adj.Ind Alloc * PCI.         =(24)*(25)       0.73      11.59       0.32       0.24       0.08       0.18       0.12       0.06
(27) Final PE RVU...................  Step 18................  =(Adj Dir + Adj Ind) *     =((14)+(26)) *       1.01      13.04       0.54       0.46       0.08       0.29       0.23       0.06
                                                                Other Adj.                    Other Adj)
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Note: 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] = [step9]/[step10].
Note: The use of any particular conversion factor (CF) in Table 5 to illustrate the PE Calculation has no effect on the resulting RVUs.
Note: The Other Adjustment includes an adjustment for the equipment utilization change.


[[Page 67560]]

3. Changes to Direct PE Inputs for Specific Services
    In this section, we discuss other CY 2015 revisions related to 
direct PE inputs for specific services. The final direct PE inputs are 
included in the final rule CY 2015 direct PE input database, which is 
available on the CMS Web site under downloads for the CY 2015 PFS final 
rule with comment period at http://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/PhysicianFeeSched/PFS-Federal-Regulation-Notices.html.
a. RUC Recommendation for Monitoring Time following Moderate Sedation
    We received a recommendation from the RUC regarding appropriate 
clinical labor minutes for post-procedure moderate sedation monitoring 
and post-procedure monitoring. The RUC recommended 15 minutes of RN 
time for one hour of monitoring following moderate sedation and 15 
minutes of RN time per hour for post-procedure monitoring (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 adjust these clinical labor 
minutes as indicated in Table 5 as ``Change to Clinical Labor Time.''

                  Table 5--Codes With Changes to Post-Procedure Clinical Labor Monitoring Time
----------------------------------------------------------------------------------------------------------------
                                                                                        RUC
                                                                                    recommended
                                                                      Current       total post-      Change to
                            CPT Code                                monitoring       procedure    clinical labor
                                                                    time (min)      monitoring      time (min)
                                                                                    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 supporting our proposal to accept 
the RUC recommendation, without refinement, to adjust the clinical 
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, cryotherapy) and 50200 (Renal biopsy; percutaneous, by 
trocar or needle), than the current time.
    Response: We appreciate commenters' support for our proposal. After 
consideration of comments received, we are 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 Standard Moderate Sedation Package
    We received a RUC recommendation to modify PE inputs included in 
the standard moderate sedation package. Specifically, the RUC indicated 
that several specialty societies have pointed to the need for a 
stretcher during procedures for which moderate sedation is inherent in 
the procedure. Although the RUC did not recommend that we make changes 
to PE inputs for codes at this time, the RUC indicated that its future 
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 procedure 
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 required for the stretcher 
based 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 
procedures. 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 modify the standard moderate sedation input package to 
include a stretcher for the same length of time as the other equipment 
items in the moderate sedation package. The revised moderate sedation 
input package will be applied 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 think that the stretcher, as expressed through the allocation 
of equipment minutes, should be allocated with more granularity than 
the equipment costs that are allocated to other similar items.
    Comment: We received comments supporting our proposal to add the 
stretcher to the moderate sedation package, including support to 
include the stretcher for the same length of time as the other 
equipment items included in the moderate sedation package since it is 
used by the patient for the duration

[[Page 67561]]

of their recovery and not available to other patients during that time.
    Response: We appreciate the commenters' support for our proposal. 
After consideration of comments received, we are finalizing 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 
codes 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 regarding 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 these items are no longer a typical resource input; 
these items are detailed in Table 6. The RUC also recommended that the 
Picture Archiving and Communication System (PACS) equipment be included 
for these imaging services since these items are now typically used in 
furnishing imaging services. We received a description of the PACS 
system as part of the recommendation, which 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 for 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 minutes 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 which case 
we proposed to allocate the intraservice work time to ED021. For 
services valued only in the facility setting, we proposed to allocate 
the post-service clinical labor time to ED021, since the film supply 
and/or equipment inputs were previously associated with the post-
service period.

 Table 6--RUC-Recommended Supply and 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, radiographic, 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 workstation, 3D
                                   reconstruction CT-MR.
ED016...........................  computer workstation, 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 procedures from its 
recommendation because (a) the dominant specialty indicated that 
digital technology is not yet 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 that 
involve imaging is to exempt services from the transition from film to 
digital PE inputs based on information reported by individual 
specialties. Although we understand that the migration from film 
technology to digital technology may progress at different paces for 
particular specialties, we do not have information to suggest that the 
migration is not occurring for all procedures that require the storage 
of images. Just as it was appropriate to use film inputs as a proxy for 
some services for which digital inputs were typical pending these 
changes in the direct PE input database, we believe it is appropriate 
to use digital inputs as a proxy for the services that may still use 
film, pending their migration to digital technology. In addition, since 
the RUC conducted its collection of information from the specialties 
over several years, we believe the migration process from film to 
digital inputs has likely continued over the time period during which 
the information was gathered, and that the 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 all 
procedures in the direct PE database, including those listed in Table 
7. We sought comment on whether 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.

     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.

[[Page 67562]]

 
92523...........................  Speech sound lang comprehend.
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 mins.
------------------------------------------------------------------------

    Finally, we noted that the RUC recommendation also indicated that, 
given the labor-intensive nature of reviewing all clinical labor tasks 
associated with film technology, these times would be addressed as 
these codes are reviewed. We agreed with the RUC that reviewing and 
adjusting the times for each code would be difficult and labor-
intensive since the direct PE input database does not allow for a 
comprehensive adjustment of the clinical labor time based on changes in 
particular clinical labor tasks. To make broad adjustments 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 post-
service period, as it does now. We recognized this situation presents 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 display clinical labor times as allocated 
to each individual clinical labor task for a sample of procedures. We 
displayed 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 allocate equipment 
minutes to clinical labor tasks in a more consistent and efficient 
manner. Given the number of procedures and the 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 this modification to the design of the direct PE input 
database.
    As discussed in section II.G. of this final rule with comment 
period, some of the RUC recommendations for 2015 included film items as 
practice expense inputs. For existing codes, the database from the 
proposed rule already included the PACS workstation proxy. However, for 
new services, as with the current items in the database, we have 
replaced the film items with the PACS workstation proxy. The codes 
affected by this change are listed in Table 8.

            Table 8--Codes Affected by Removal of Film Inputs
------------------------------------------------------------------------
              HCPCS                          Short descriptor
------------------------------------------------------------------------
22510...........................  Perq cervicothoracic inject.
22511...........................  Perq lumbosacral injection.
22513...........................  Perq vertebral augmentation.
22514...........................  Perq vertebral augmentation.
62302...........................  Myelography lumbar injection.
62303...........................  Myelography lumbar injection.
62304...........................  Myelography lumbar injection.
62305...........................  Myelography lumbar injection.
71275...........................  Ct angiography chest.
72191...........................  Ct angiograph pelv w/o&w/dye.
72240...........................  Myelography neck spine.
72255...........................  Myelography thoracic spine.
72265...........................  Myelography l-s spine.
72270...........................  Myelogphy 2/> spine regions.
74174...........................  Ct angio abd&pelv w/o&w/dye.
74175...........................  Ct angio abdom w/o & w/dye.
74230...........................  Cine/vid x-ray throat/esoph.
76942...........................  Echo guide for biopsy.
93312...........................  Echo transesophageal.
93314...........................  Echo transesophageal.
93320...........................  Doppler echo exam heart.
93321...........................  Doppler echo exam heart.
93325...........................  Doppler color flow add-on.
93880...........................  Extracranial bilat study.
93882...........................  Extracranial uni/ltd study.
93886...........................  Intracranial complete study.
93888...........................  Intracranial limited study.
93895...........................  Carotid intima atheroma eval.
93925...........................  Lower extremity study.
93926...........................  Lower extremity study.
93930...........................  Upper extremity study.
93931...........................  Upper extremity study.
93970...........................  Extremity study.
93971...........................  Extremity study.
93975...........................  Vascular study.
93976...........................  Vascular study.
93978...........................  Vascular study.
93979...........................  Vascular study.
------------------------------------------------------------------------

    Comment: We received many comments on our proposal to remove the 
equipment and supply inputs associated with 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 desktop computer as the proxy item 
stated that the PACS workstation was significantly more expensive and 
included greater functionality than a desktop computer. Some commenters 
opposed our proposal to maintain the current equipment time allocated 
to the computer desktop for the 31 services that already included this 
equipment item, suggesting that it was incorrect to eliminate the film 
inputs without proportionately increasing the proxy time for ED021. 
Some commenters requested a delay in implementation until stakeholders 
provide invoices or otherwise work with CMS to identify prices for the 
PACS items. Some commenters suggested CMS should develop a means to 
allocate digital technology costs to individual services, even if it is 
difficult to do so. Another commenter explained that it is difficult 
for stakeholders to obtain invoices that display prices for individual 
items, such as the PACS workstation, since the price 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 other commenters requested that CMS accept the RUC recommendation 
regarding the PACS workstation.
    Response: We appreciate commenters' support for our proposal to 
incorporate the transition from film to digital imaging technology into 
the direct PE input database. With regard to the pricing of the PACS 
workstation, as with all inputs, we would prefer to use actual paid 
invoices to establish the input price. However, in the absence of 
invoices demonstrating the actual cost, we believe that use of a proxy 
to price the appropriate inputs, in this case the PACS workstation, is 
preferable to

[[Page 67563]]

continuing to use inputs that we know are no longer typical. We made 
the proposal 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 resource costs are not 
similar or to suggest a more appropriate proxy. Nor were any paid 
invoices submitted. Absent such information, we continue to believe 
that using 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 already included the desktop 
computer as an equipment input, we will include the desktop computer as 
a proxy for the PACS workstation using the same methodology as for 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 receive pricing 
information, we will create a new equipment item called ``desktop 
computer (proxy for PACS workstation),'' which will be allocated to 
each procedure using the methodology described above.
    Comment: Some commenters opposed our removal of the film inputs 
from services that were not included in the RUC recommendation, but did 
not provide a rationale for their opposition.
    Response: For the reasons we explained in making the proposal and 
reiterate above, we continue to believe that it is appropriate to 
remove these items from the direct PE database.
    Comment: Some commenters provided specific suggestions regarding 
the use of digital inputs should CMS decide 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, 
specialized software to process the image, and multiple high definition 
monitors used by the interpreting radiologist. Commenters provided an 
invoice for the image capture plate at a price of $25,600 indicating 
that this item replaces the film as the media to record the image.
    Response: We appreciate that commenters provided us with an invoice 
for the 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 service is 
furnished using fixed equipment, we are not including the image capture 
plate that is associated with portable equipment as an input for the 
imaging procedure codes. We also do not believe that high definition 
monitors used by the interpreting radiologist are appropriately 
included in the technical component of imaging procedures; rather, 
these are indirect costs associated with the professional component of 
the service. Therefore, we are not including the high definition 
monitors as an input for these services. Finally, to determine whether 
the software is appropriately categorized as a direct PE input, we need 
more information about the functionality of the software, and whether 
it is used in furnishing the typical x-ray service (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 commenters suggested 
that there may be more feasible approaches to break out the individual 
clinical labor tasks associated with each portion of the service (pre-
service period, service period, and post-service period). The RUC 
suggested that we post all PE worksheets and supporting materials in 
code-order on our Web site. Other commenters did not suggest a specific 
alternative approach to providing detail for the individual clinical 
labor tasks.
    Response: We appreciate the RUC's suggestion 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 approach to 
break out the individual clinical labor tasks associated with each 
service 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 available in the 
same format as in previous years, but that additional public use files 
now display the clinical labor tasks for each service period, providing 
greater transparency and enabling comparisons 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 files 
available on the CMS Web site under downloads for the CY 2015 PFS final 
rule with comment period at http://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/PhysicianFeeSched/PFS-Federal-Regulation-Notices.html
d. Inputs for Digital Mammography Services
    Mammography services are currently reported and paid using both CPT 
codes and G-codes. To meet the requirements of the Medicare, Medicaid, 
and SCHIP Benefits Improvement and Protection Act of 2000 (BIPA), we 
established G-codes for use beginning in CY 2002 to pay for mammography 
services using new digital technologies (G0202 screening mammography 
digital; G0204 diagnostic mammography digital; G0206 diagnostic 
mammography digital). We continued to use the CPT codes for mammography 
services furnished using film technology (77055 (Mammography; 
unilateral); 77056 (Mammography; bilateral); 77057 (Screening 
mammography, bilateral (2-view film study of each breast)). As we 
discussed previously in this section, the RUC has recommended that all 
imaging codes, including mammography, be valued using digital rather 
than film inputs because the use of film is no longer typical. A review 
of Medicare claims data shows that the mammography CPT codes are billed 
extremely infrequently, and that the G-codes are billed for the vast 
majority of mammography claims, confirming the RUC's conclusion that 
the typical service uses digital 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 both 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 reviewed and

[[Page 67564]]

significant technological 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 established to reflect the use of digital technology, which is now 
typical.
    As discussed in section II.B of this final rule with comment 
period, we proposed these CPT codes as potentially misvalued and 
requested that the RUC and 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 final 
rule with comment period, we will continue to maintain separate payment 
rates for film and digital mammography while we consider revaluation of 
all mammography services. For CY 2015, we will therefore maintain both 
the G-codes and CPT codes; we will continue using the 2014 RVUs from 
each of the following codes to price them for 2015: G0202, G0204, 
G0206, 77055, 77056, and 77057. 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 final rule with comment 
period, where we address comments received on this proposal.
e. Radiation Treatment Vault
    In previous rulemaking (77 FR 68922, 78 FR 74346), we indicated 
that we included the radiation treatment vault as a direct PE input for 
several recently reviewed radiation treatment codes for the sake of 
consistency with its previous inclusion as a direct PE input for some 
other radiation treatment services, but that we intended to review the 
radiation treatment vault input and address whether or not it should be 
included in the direct PE input database for all services in future 
rulemaking. Specifically, we questioned whether 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 stakeholders who indicated that the vault should be 
classified as a direct cost. However, upon review of the information 
received, we believed that the specific structural components required 
to house the linear accelerator are similar in concept to components 
required to house other medical equipment such as expensive imaging 
equipment. In general, the electrical, plumbing, and other building 
specifications are often unique to the intended functionality of a 
given building, including costs that are attributable to the specific 
medical equipment housed in the building, but those building 
characteristics do not represent direct medical equipment costs in our 
established PE methodology. Therefore, we believed that the special 
building requirements indicated for the radiation treatment vault to 
house a linear accelerator do not represent a direct cost in our PE 
methodology, and that the vault construction is instead accounted for 
in the indirect PE methodology, just as the building and 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 accounted for in the indirect PE 
methodology.

Table 9--HCPCS Codes Affected 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 regarding our proposal to remove 
the radiation treatment vault as a direct cost from the radiation 
treatment delivery codes. Although one commenter supported the 
proposal, most commenters opposed the proposal. In general, commenters 
reiterated their rationale for inclusion of the vault as a direct 
practice expense input, asserting that the vault is necessary for the 
functioning of the equipment, serves a unique medical need, cannot be 
separated from the treatment delivered by the linear accelerator, and 
cannot be repurposed for another use. Commenters also stated that the 
Internal Revenue Code treats the vault as medical equipment that is 
separately depreciable from the building itself. For the most part, 
commenters objected to the removal of the vault given the context of 
declining Medicare payment for radiation oncology services over the 
past few years, or in conjunction with the revised radiation treatment 
code set. Specifically, several commenters suggested that stakeholders 
cannot provide meaningful comment about the impact of the vault 
proposal in the context of other pending changes. Some commenters 
requested a phase-in of any decrease in payment so that providers of 
radiation therapy services have an opportunity to adjust their practice 
costs. Several commenters also suggested that the change in payment 
could exacerbate problems in access to oncology services for Medicare 
patients.
    Response: We appreciate commenters' concerns regarding the proposal 
to remove the vault as a direct practice expense input. We understand 
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 the 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 
parallels between the two are not necessarily instructive or relevant. 
We are not finalizing 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 procedures, 
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 costs involved in furnishing treatment services compare to 
the indirect costs in providing other radiation oncology services.
    Response: We understand the concerns of commenters regarding the 
importance of ensuring that the costs related to the vault are included 
in the

[[Page 67565]]

PE methodology. We want to point out, however, that within the 
established PE methodology, the allocation of indirect PE to individual 
codes has significant impact on the PE RVUs that determine Medicare 
payment for individual services. In other words, 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 allocation of indirect PE 
for particular PFS services based on changes in either direct PE 
inputs, work RVUs, work time, or utilization data, impacts the amount 
of indirect PE allocated to all 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 further 
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 publication 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 
correction to the clinical labor type for this service.
    Comment: Commenters appreciated our proposal to correct this error.
    Response: We appreciate commenters' support for our proposal, and 
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 included 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 database reflects this correction.
g. Work Time
    Subsequent to the publication 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 equal the sum of the component 
parts (pre-service, intra-service, post-service, and times associated 
with global period visits). The times in the CY 2015 work time file 
reflect our corrected values for total work time. Second, for a subset 
of services, the values in the pre-positioning time, pre-evaluation 
time, and pre-scrub-dress-wait time, were inadvertently transposed. We 
note that this error had no impact on calculation of the total times, 
but has been corrected in the CY 2015 work time file. Third, minor 
discrepancies for a series of interim final codes were identified 
between the work time file and the way we addressed these codes in the 
preamble text. Therefore, we have made adjustments to the work time 
file to reflect the decisions indicated in the preamble text. The work 
time file is available on the CMS Web site under the supporting 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 time file is located at http://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/PhysicianFeeSched/PFS-Federal-Regulation-Notices-Items/CMS-1600-FC.html.
    Comment: A commenter supported our proposal to correct the work 
times associated with the procedures affected 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 available on the CMS Web site under the supporting 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 comment period (75 FR 73205), we 
finalized a process to act on public requests to update equipment and 
supply price and equipment useful life inputs through annual rulemaking 
beginning with 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 supply items. We proposed to increase 
the price associated with these supply items.
    We continue to believe it is important to maintain a periodic and 
transparent process to update the price of items to reflect typical 
market prices in our ratesetting methodology, and we continue to study 
the best way to improve our current 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 community to both request supply price updates by providing us 
copies of paid invoices, and to object to proposed changes in price 
inputs for particular items by providing additional information about 
prices available to the practitioner community. We remind stakeholders 
that PFS payment rates are developed within a budget neutral, relative 
value system, and any increases in price inputs for particular supply 
items result in corresponding decreases to the relative values of all 
other direct PE inputs.
    We also received a RUC recommendation to update the prices 
associated 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 
(kit, 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 these items based on these 
recommendations.
    Comment: We received several comments regarding our concern about 
obtaining accurate pricing information for equipment and supply items 
included in the direct PE database. The RUC indicated that it would 
continue to work with specialty societies to obtain

[[Page 67566]]

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 obtain, given that the RUC 
process collects lists of resources required to furnish services in the 
physician office using a standardized process that is typically 
accompanied by invoices. Another commenter stated that CMS used only 
the lowest-cost invoice for a particular equipment item since the other 
invoices included ``soft costs,'' and that CMS should establish an 
approach that would allow invoices to be used even if they contain 
``soft costs.''
    Response: We appreciate the RUC's assistance in obtaining paid 
invoices from the specialty societies. These invoices are helpful in 
pricing inputs. We disagree that we use the lowest-cost invoice because 
it had the lowest cost; 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 pricing 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 with CMS's position that the RUC 
PE Subcommittee's review results in biased or inaccurate 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 
rulemaking (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 obtaining 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 prices of direct PE item. 
Without assigning a price, the input cannot be factored in to our PE 
RVU methodology. Our price information is almost exclusively anecdotal, 
and generally updated only through voluntary submission of a small 
number of invoices from the same practitioners that furnish and are 
paid for the services that use the particular inputs. Therefore, we 
continue to believe there is potential for bias in the information we 
receive.
    Comment: In its comment, the RUC suggested that an annual CMS 
review of paid invoices for high-cost supplies would be appropriate. A 
commenter referenced comments made on the CY 2014 PFS final rule with 
comment period, and expressed agreement with those commenters that the 
provision of pricing information is sensitive because of issues 
involving proprietary pricing information and price negotiations for 
individual practitioners. This commenter also agreed with CMS that such 
information would be less sensitive if it confirmed inputs contained in 
the direct PE database. However, the commenter noted that requiring 
paid invoices from this point forward only partially addresses the 
concern since many existing inputs are not based on paid invoices; 
specifically, societies 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 suggested 
that CMS may need to undertake a comprehensive review of all direct PE 
inputs and obtain paid invoices to systematically address its concerns.
    Response: We share commenters' concerns that codes that are being 
reviewed may be disadvantaged relative to codes that contain input 
prices that may not be based on paid invoices; and note that we rely on 
the public process to ensure 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 
reasonable and current, and to provide us with updated pricing 
information, particularly regarding high cost supplies that have a 
greater impact on relativity. We refer readers to section 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.
    Comment: We received some comments in support of our proposal to 
update the price for SL196 (kit, HER-2/neu DNA Probe).
    Response: We appreciate the commenters' support 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 necessary before proceeding to update the input price. 
Therefore, we are not finalizing our proposal to update the price 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, balloon, esophageal or rectal 
(graded distention test)).
    Response: We are finalizing 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' support for our proposal to 
update the price for SA019 and SA042. After consideration of comments 
received, we are finalizing the price updates for SA019 and SA042.
i. New Standard Supply Package for Contrast Imaging
    The RUC recommended creating a new direct PE input standard supply 
package ``Imaging w/contrast, standard package'' for contrast enhanced 
imaging, with a price of $6.82. This price reflects the combined prices 
of the medical supplies included in the package; these items are listed 
in Table 10. We proposed to accept this recommendation, but sought 
comment on whether all of the items included in the package are used in 
the typical case. The CY 2015 direct PE database reflects this change 
and is available on the CMS Web site under the supporting data files 
for the CY 2015 PFS proposed rule at http://www.cms.gov/PhysicianFeeSched/.

                               Table 10--Standard Contrast Imaging Supply Package
----------------------------------------------------------------------------------------------------------------
                                        SCMS  supply
     Medical supply description             code                  Unit               Quantity          Price
----------------------------------------------------------------------------------------------------------------
Kit, IV starter.....................  SA019             Kit.....................               1          $1.60
Gloves, non-sterile.................  SB022             Pair....................               1           0.084

[[Page 67567]]

 
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.             SH068             Item....................               1           0.700
 bacteriostatic (30ml uou).
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 labs that utilize contrast-enhanced 
ultrasound, additional items are typically part of the contrast imaging 
supply package, including 2x2 gauze pads, a stopcock, and tape. Another 
commenter suggested that a power injector should also be included in 
the standard contrast imaging supply package. Commenters also noted 
that CMS provided limited information regarding how the prices were 
assigned to the supply items, and pointed to discrepancies between the 
direct PE database files and the prices quoted in the table.
    Response: We appreciate commenters' support for our proposal. We 
note that the RUC recommendation for the standard contrast imaging 
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 echocardiography labs 
conduct contrast-enhanced ultrasound studies, we do not have 
information to suggest that these items are used for other imaging 
studies, such as CT and MRI contrast-enhanced studies. We would welcome 
more information on whether these items should be included in the newly 
created standard contrast imaging kit, as well as whether the power 
injector is used whenever 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 kit is that we proposed to update the price at 
the same time that we proposed to create 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 direct PE database, and the codes associated with these items were 
listed in the table in the proposed rule. After consideration of 
comments received, we are finalizing our proposal to create a standard 
contrast imaging supply pack, with a revised price of $7.06.
j. Direct PE Inputs for Stereotactic Radiosurgery (SRS) Services (CPT 
Codes 77372 and 77373)
    In the CY 2014 PFS final rule with comment period (78 FR 74245), we 
summarized comments received about whether CPT codes 77372 and 77373 
would accurately reflect the resources used in furnishing the typical 
SRS delivery 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, complete course of therapy in one session or first 
session of fractionated treatment), and G0340 (Image-guided robotic 
linear accelerator-based stereotactic radiosurgery, delivery including 
collimator changes and custom plugging, fractionated treatment, all 
lesions, per session, second through fifth sessions, maximum five 
sessions per course of treatment). We indicated that we would consider 
deleting these codes in future rulemaking.
    Most commenters responded that the CPT codes 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 suggest that the CPT codes did not 
describe the services or that the direct PE inputs for the CPT codes 
were inaccurate. Based on a review of the comments received, we had no 
indication that the direct PE inputs included 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 the CPT codes for SRS services, and to delete the G-
codes used to report robotic delivery of SRS.
    Comment: We received several comments regarding our proposal to 
delete the SRS G-codes. Some commenters supported our proposal, but 
most opposed our proposal on the grounds that the direct PE inputs 
included in the CPT codes do not reflect the typical resource inputs 
used in furnishing robotic SRS services. Some commenters 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 regarding 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 appropriateness of deleting the G-codes and 
paying for all SRS/SBRT services using the CPT codes. Therefore, we 
will not delete the G-codes for 2015, but will instead work with 
stakeholders to identify an alternate approach and reconsider this 
issue in future rulemaking.
k. Inclusion of Capnograph for Pediatric Polysomnography Services
    We proposed to include equipment item EQ358, Sleep capnograph, 
polysomnography (pediatric), for CPT codes 95782 (Polysomnography; 
younger than 6 years, sleep staging with

[[Page 67568]]

4 or more additional parameters of sleep, attended by a technologist) 
and 95783 (Polysomnography; younger than 6 years, sleep staging with 4 
or more additional parameters of sleep, with initiation of continuous 
positive airway 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 support of our proposal to 
include the capnograph in CPT codes 95782 and 95783.
    Response: We appreciate commenters' support for our proposal. After 
consideration of comments received, we are finalizing 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 for 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 the accuracy of some of the information we use in 
developing PE RVUs. In particular, as discussed in the CY 2014 PFS 
final rule with comment period, we have several longstanding concerns 
regarding the accuracy of direct PE inputs, including both items and 
procedure time assumptions, and prices of individual supplies and 
equipment (78 FR 74248-74250). In addition to the concerns regarding 
the inputs used in valuing particular procedures, we also noted that 
the allocation of indirect PE is based on information collected several 
years ago (as described above) and will likely need to be updated in 
the coming years.
    To mitigate the impact of some of these potentially problematic 
data used in developing values for individual services, in rulemaking 
for the CY 2014 PFS, we proposed to limit the nonfacility PE RVUs for 
individual 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 comparison 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 proposal, the vast majority 
of which urged us to withdraw the proposal. Some commenters questioned 
the validity of our assumption that facilities' costs for providing all 
services are necessarily higher than the costs of physician offices or 
other nonfacility settings. Other commenters expressed serious concerns 
with the asymmetrical comparisons between PFS payment 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 amounts 
for particular procedures is not the most appropriate or effective 
approach to ensuring 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 services are 
grouped into rates that reflect the costs of a range of services. 
Second, commenters suggested that since the ASC rates reflect the OPPS 
relative weights to determine payment rates 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 
other reasons raised by commenters, we did not propose a similar policy 
for the CY 2015 PFS. If we consider using OPPS or ASC payment rates in 
developing PFS PE RVUs in future rulemaking, we would consider all of 
the comments received regarding the technical application of the 
previous proposal.
    After thorough consideration of the comments regarding the CY 2014 
proposal, we continue to believe that there are various possibilities 
for leveraging 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 continue to believe that the routinely updated, 
auditable resource cost information submitted contemporaneously by a 
wide array of providers across the country is a valid reflection of 
``relative'' resources and could be useful to supplement the resource 
cost information developed under 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 PAMA added a new subparagraph (M) under 
section 1848(c)(2) of the Act that gives us authority to collect 
information on resources used to furnish services from eligible 
professionals (including physicians, non-physician practitioners, PTs, 
OTs, SLPs and qualified audiologists), and other 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, including those that are 
provider-based, and other non-facility entities paid through the PFS. 
We believe such efforts will be challenging given the wide variety of 
practices, and that any effort will likely impose some burden on 
eligible professionals paid through the PFS regardless of the scope and 
manner of data collection. Currently, through one of the validation 
contracts discussed in section II.B. of this final rule with comment 
period, we have been gathering time data directly from physician 
practices. Through this project, we have learned much about the 
challenges for both CMS and the eligible professionals 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 
concerns over the accuracy of this or other PE surveys as a way of 
gathering data on PE inputs 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 authority to develop and 
use alternative approaches to establish PE relative values, including 
the use of data from other suppliers and providers of services. We are 
exploring the best approaches for exercising this authority, including 
with respect to use of hospital outpatient cost data. We understand 
that

[[Page 67569]]

many stakeholders will have concerns regarding the possibility of using 
hospital outpatient cost data in developing PE RVUs under the PFS, and 
we want to be sure we are aware of these 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 the PFS PE 
methodology. We noted that the resulting PFS payment amounts would not 
necessarily conform to OPPS payment amounts since OPPS payments are 
grouped into APCs, while PFS payments would continue to be valued 
individually and would remain subject to the relativity inherent in 
establishing PE RVUs, budget neutrality adjustments, and PFS updates. 
We expressed particular interest in comments that compare such 
possibilities to other broad-based, auditable, mechanisms for data 
collection, including any we might consider under the authority 
provided 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 set resource assumptions for 
only a subset of PFS services, or as a base amount to be adjusted by 
code or specialty-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 the growing trend toward hospital acquisition of physicians' 
offices and how the subsequent treatment of those locations as off-
campus provider-based outpatient departments affects payments under PFS 
and beneficiary cost-sharing. MedPAC continues to question the 
appropriateness of increased Medicare payment and beneficiary cost-
sharing when physicians' offices become hospital outpatient 
departments, and to recommend that Medicare pay selected hospital 
outpatient services at PFS rates (MedPAC March 2012 and June 2013 
Report to Congress). We noted that we also remain concerned about the 
validity of the resource data as more physician practices become 
provider-based. Our survey data reflects the PE costs for particular 
PFS specialties, including a proportion of practices that may have 
become provider-based since the survey was conducted. Additionally, as 
the proportion of provider-based offices varies among physician 
specialties, so do the relative accuracy of the PE survey data. Our 
current PE methodology primarily distinguishes between the resources 
involved in furnishing services in two sites of service: 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 direct and indirect PEs associated with 
the work and the PE of the service. In contrast, when services are 
furnished in the facility setting, some costs that would be PEs in the 
office setting are incurred by the facility. 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 incurred 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 also have discussed this issue as it relates to 
accurate valuation of visits within the postoperative period of 10- and 
90-day global codes in section II.B.4 of this final rule with comment 
period.
    To understand how this trend is affecting Medicare, including the 
accuracy of payments made through the PFS, we need to develop data to 
assess the extent to which this shift toward hospital-based physician 
practices is occurring. To that end, during CY 2014 rulemaking we 
sought comment regarding the best method for collecting information 
that would allow us to analyze the frequency, type, and payment for 
services furnished in off-campus provider-based hospital departments 
(78 FR 74427). We received many thoughtful comments. However, the 
commenters did not present a consensus 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 information across two different payment 
systems would be to create a HCPCS modifier to be reported with every 
code for physicians' and hospital services furnished in an off-campus 
provider-based department of a hospital.
    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 organization has provider-based 
status are specified in Sec.  413.65, and we define a hospital campus 
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 buildings 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.)
    Therefore, we proposed to collect this information on the type and 
frequency of services furnished in off-campus provider-based 
departments in accordance 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 
allow 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 services. Furthermore, 
this information would be critical in order to develop proposed 
improvements to our PE data or methodology that would appropriately 
account for the different resource costs among traditional office, 
facility, and off-campus provider-based settings. We also sought 
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 off-campus 
provider-based departments of hospitals, however, several commenters 
expressed concern that the HCPCS modifier would create additional 
administrative burden for providers. Many of these commenters stated 
that the new modifier would require significant 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 education and training would be 
required for physician offices to attach a modifier to services 
furnished in an off-campus provider-based department. These same 
commenters suggested that a new place of service (POS) code would be 
more appropriate for physician billing. Several commenters suggested 
that CMS

[[Page 67570]]

should re-propose a detailed data collection methodology, test it with 
providers, make adjustments, and allow additional time for 
implementation.
    Response: While we understand commenters' 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 information 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 that 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 
implementation later in this section.
    Comment: Some commenters who were concerned about the 
administrative burden of the new HCPCS modifier suggested several 
alternative 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 they believed this approach would be less administratively 
burdensome than attaching a modifier to each service reported 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-2552-10). Some 
commenters suggested using provider numbers and addresses to identify 
off-campus PBDs, or changing the provider enrollment process to be able 
to track this data. Yet other commenters suggested creating a new bill 
type 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 clearly identify specific services furnished at 
off-campus PBDs, and would provide better information about the 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 claims-
based modifiers. However, other commenters stated that additional 
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 POS code to obtain data on 
services furnished in off-campus PBDs of a hospital, we note that POS 
codes are only reported on professional claims and are not included on 
institutional 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 department. (More information on existing POS codes is 
available on the CMS Web site at http://www.cms.gov/Medicare/Coding/place-of-service-codes/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 hospital 
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, 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 
modifier, not a POS code. However, 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 campus versus in an off-campus provider-based department would 
require less staff training and education than would the use of a 
modifier on the professional claim. Additionally, professional claims 
only have space for four modifiers; while a very small percentage of 
professional claims have four modifiers, required use of an additional 
modifier for every professional 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 that a new 
professional claim is required whenever the place of service changes. 
That is, even if the same practitioner 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 furnished in the outpatient hospital department would be 
submitted on a separate claim with POS 22 (Outpatient Hospital). 
Likewise, if a new POS code were to be created for off-campus 
outpatient provider-based hospital department, a separate claim for 
services furnished in that setting would 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 after further consultation with Medicare billing 
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 professional claim since a POS code is 
already required for every professional claim.
    With respect to adding new fields to existing claim forms or 
creating a new bill type, we do not believe that this data collection 
warrants these measures. We believe that those changes would create 
greater administrative burden than the proposed HCPCS 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 would 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 these types of codes already exist generally for 
hospital and professional claims, providers and suppliers 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

[[Page 67571]]

would provide us with detailed information on exactly which services 
were furnished 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 available NPI and facility address data. Hospitals are 
required 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 from 
the master address for the hospital on file in CMS claims systems in 
value code 78 (pub 100-04, transmittal 1681, February 13, 2009). 
However, the billing ZIP code for the hospital main campus could be 
broad enough to incorporate on and off-campus provider-based 
departments. Further, a ZIP code reported in value code 78 does not 
allow CMS to distinguish between services furnished 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 suggestion that CMS use currently 
reported Medicare hospital cost report (CMS-2552-10) data to identify 
services furnished at off-campus PBDs, we note that though aggregate 
data on services furnished in different settings must be reported 
through the appropriate cost center, we would not be able to obtain the 
service-specific level of detail that we would be able to obtain from 
claims data.
    We will take under consideration the suggestion that CMS create a 
way for hospitals to report their acquisition of physician 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 provider 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 proposed modifier would not 
allow CMS to know the precise location of the off-campus provider-based 
department for billed services or when services are furnished at 
different off-campus provider-based locations in the same day.
    Response: We agree that neither 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 type and frequency of services furnished at all off-campus 
locations will assist CMS in better understanding the distribution of 
services between on and off-campus locations.
    Comment: MedPAC believed there may be some value in collecting data 
on services furnished in off-campus provider-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 prevent the 
development of policies to align payment rates across settings. MedPAC 
encouraged CMS to seek legislative authority to set equal payment rates 
across settings for evaluation and management office visits and other 
select services.
    Response: We thank MedPAC for its support of our data collection 
efforts to learn more about the frequency and types of services that 
are being furnished in off-campus PBDs.
    Comment: Many commenters suggested that providers 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 requested 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 believe that the January 1st effective date 
that applies to most policies adopted in the final rules with comment 
period for both the PFS and the OPPS would provide sufficient lead 
time, we understand commenters' concerns with the proposed timeline for 
implementation given that the new reporting requirements 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 the revised POS codes are ready and 
integrated into CMS claims systems, practitioners would be required to 
use them, as applicable. More information on the availability of the 
new POS codes will be forthcoming 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 
professional claims because each professional claim requires a POS code 
in order to be accepted by Medicare. 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 are 
already accustomed to using a POS on every claim they submit.
    We also are finalizing our proposal to create 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 modifier for services 
furnished at an off-campus PBD will not be mandatory until January 1, 
2016, in order to allow providers time to make systems changes, test 
these changes, and train staff on use of the new modifier before 
reporting is required. We welcome early reporting of the modifier and 
believe a full year of preparation should provide hospitals with 
sufficient time to modify their systems for accurate reporting.
    Comment: Many commenters expressed concern that this data 
collection would eventually lead to equalizing payment for similar 
services furnished in the non-facility setting and the off-campus PBD 
setting. Several commenters noted that the trend of hospitals acquiring 
physician practices is due to efforts to better integrate care 
delivery, and suggested that CMS weigh the benefits of care integration 
when deciding payment changes. Some commenters suggested that CMS 
should use the data to equalize payment for similar services between 
these two settings. These commenters suggest that there is little 
difference in costs and care between the two settings that would 
warrant the difference in payment. Several of these commenters 
highlighted beneficiary cost sharing as one reason for site-neutral 
payment, noting that the total 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 comments received. At this time, 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 furnished in the off-campus PBD setting.
    Comment: Several commenters noted that 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 analyzing 
the impact of this trend.

[[Page 67572]]

    Response: We agree that, in analyzing the impact of this trend, 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 code 
as finalized in this rule will be an important tool in furthering this 
analysis.
    Comment: Some commenters suggested that the term ``off-campus'' 
needs to be better defined. Commenters asked how billing would occur 
for hospitals with multiple campuses since the CMS definition of campus 
references main buildings and does not include remote locations. One 
commenter also asked whether the modifier is intended to cover services 
furnished in free-standing emergency departments.
    Response: For purposes of the modifier and the POS codes we are 
finalizing in this final rule with comment period, we define a 
``campus'' using the definition at Sec.  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 
buildings 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 to 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 ``remote location of a hospital'' 
is defined in our regulations at section 413.65(a)(2). Under the 
regulation, a ``remote location'' includes a hospital campus other than 
the main hospital campus. Specifically, a remote location is ``a 
facility or an organization that is either created 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 locations of a hospital. The term ``remote location'' does not 
include ``satellite'' locations of a hospital. However, since a 
satellite facility 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 facilities are described in our 
regulations at Sec.  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, excluding 
services furnished in a remote location or satellite facility of the 
hospital.
    We also appreciate the comment on emergency departments. We do not 
intend for hospitals to report the new modifier for services furnished 
in emergency departments. We note that there is already a POS code for 
the emergency department, POS 23 (emergency room-hospital), and this 
would continue to be used on professional claims for services furnished 
in emergency departments. That is, the new POS code for off-campus 
hospital PBDs that will be created for purposes of this data collection 
would not apply to emergency department services. Hospitals and 
practitioners that have questions about which departments are 
considered to be ``off-campus PBDs'' should review additional guidance 
that CMS releases on this policy and work with the appropriate CMS 
regional office if individual, specific questions remain.
    Comment: Several commenters asked for clarification on when to 
report the modifier for services furnished both on and off-campus on 
the same day. Commenters provided several scenarios of visits and 
diagnostic services 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 the 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 clarification on whether their 
entity constitutes a provider-based department.
    Response: Provider-based departments are departments of the 
hospital that meet the criteria in Sec.  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 available to the 
public for purchase along with the rest of the Limited Data Set. 
Similarly, professional claims data with revised POS coding would be 
available as a standard analytic file for purchase.
    In summary, after consideration of the comments received, we are 
finalizing our proposal with modifications. For professional claims, 
instead 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 identify outpatient services 
furnished in on-campus, remote or satellite locations of a hospital, 
and another to identify services furnished in an off-campus hospital 
PBD setting that is not a remote location 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 these codes 
will be shared publicly as soon as practicable.
    For hospital claims, we are creating a HCPCS modifier that is to be 
reported with every code for outpatient hospital services furnished in 
an off-campus PBD of a hospital. This code will not be required to be 
reported for remote locations of a hospital defined at Sec.  412.65, 
satellite facilities of a hospital defined at Sec.  412.22(h) or for 
services furnished in an emergency department. This 2-digit modifier 
will be added to the HCPCS annual file as of January 1, 2015, with the 
label ``PO,'' the short descriptor ``Serv/proc off-campus pbd,'' and 
the long descriptor ``Services, procedures and/or surgeries furnished 
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. Additional instruction 
and provider education will be forthcoming in subregulatory guidance.

[[Page 67573]]

B. Potentially Misvalued Services Under the Physician Fee Schedule

1. Valuing Services Under the PFS
    Section 1848(c) of the Act requires the Secretary 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 time and intensity in 
furnishing the service.'' In addition, section 1848(c)(2)(C)(i) of the 
Act specifies that ``the Secretary shall determine a number of work 
relative value units (RVUs) for 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 the PE component as ``the 
portion of the resources used in furnishing the service that reflects 
the general categories of expenses (such as office rent and wages of 
personnel, but excluding malpractice expenses) 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 the MP component as ``the 
portion of the resources used in furnishing the service that reflects 
malpractice expenses in furnishing the service.'' Section 
1848(c)(2)(C)(iii) of the Act specifies that MP expense RVUs shall be 
determined based on the relative MP expense resources 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 Act directs the Secretary to conduct a 
periodic review, not less often than every 5 years, of the RVUs 
established under the PFS. Section 1848(c)(2)(K) of the Act requires 
the Secretary to periodically identify potentially misvalued services 
using certain criteria and to review and make appropriate adjustments 
to the relative values for those services. Section 1848(c)(2)(L) of the 
Act also requires the Secretary to develop a process to validate the 
RVUs of certain potentially misvalued 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 recommendations provided by the American Medical 
Association/Specialty Society Relative Value Scale Update Committee 
(RUC), the Medicare Payment Advisory Commission (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 code-by-code basis 
and consider these recommendations in conjunction with analyses of 
other data, such as claims data, to inform the decision-making 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 considering the most recently available data, we also 
assess the results of physician surveys and specialty 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 medical practice. We note that section 
1848(c)(2)(A)(ii) of the Act authorizes the use of extrapolation and 
other techniques to determine the RVUs for physicians' services for 
which specific data are not available, in addition to taking into 
account the results of consultations with organizations representing 
physicians. In accordance with section 1848(c) of the Act, we determine 
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 other health care services that physicians 
order, such as hospital services.'' In that same report MedPAC 
postulated that physicians' services under the PFS can become misvalued 
over time. MedPAC stated, ``When a new service is added to the 
physician fee schedule, it may be assigned a relatively high value 
because of the time, technical skill, and psychological stress that are 
often required to furnish that service. Over time, the work required 
for certain services would be expected to decline as physicians become 
more familiar with the service and more efficient in furnishing it.'' 
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. Likewise, services can become 
undervalued when physician work increases or PE rises.
    As MedPAC noted in its March 2009 Report to Congress, in the 
intervening years since MedPAC made its initial recommendations, ``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 directs the Secretary to 
specifically examine, as determined appropriate, potentially misvalued 
services in the following seven categories:
    <bullet> Codes and families of codes for which there has been the 
fastest growth;
    <bullet> Codes and families of codes that have experienced 
substantial changes in PEs;
    <bullet> Codes that are recently established for new technologies 
or services;
    <bullet> Multiple codes that are frequently billed in conjunction 
with furnishing a single service;
    <bullet> Codes with low relative values, particularly those that 
are often billed multiple times for a single treatment;
    <bullet> Codes which have not been subject to review since the 
implementation of the RBRVS (the so-called `Harvard-valued codes'); and
    <bullet> 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 Secretary is 
directed to examine by adding nine additional categories. These are:
    <bullet> Codes that account for the majority of spending under the 
PFS;
    <bullet> Codes for services that have experienced a substantial 
change in the hospital length of stay or procedure time;
    <bullet> Codes for which there may be a change in the typical site 
of service since the code was last valued;
    <bullet> Codes for which there is a significant difference in 
payment for the same service between different sites of service;
    <bullet> Codes for which there may be anomalies in relative values 
within a family of codes;

[[Page 67574]]

    <bullet> Codes for services where there may be efficiencies when a 
service is furnished at the same time as other services;
    <bullet> Codes with high intra-service work per unit of time;
    <bullet> Codes with high PE RVUs; and
    <bullet> Codes with high cost supplies.
    Section 1848(c)(2)(K)(iii) of the Act also specifies that the 
Secretary may use existing processes to receive recommendations on the 
review and appropriate adjustment of potentially misvalued services. In 
addition, the Secretary may conduct surveys, other data collection 
activities, studies, or other analyses, as the Secretary determines to 
be appropriate, to facilitate the review and appropriate adjustment of 
potentially misvalued services. This section of the Act also authorizes 
the use of analytic contractors to identify and analyze potentially 
misvalued codes, conduct surveys or collect data, and make 
recommendations on the review and appropriate adjustment of potentially 
misvalued services. Additionally, this section provides that the 
Secretary may coordinate the review and adjustment of any RVU with 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 using existing processes for 
consideration of coding changes) that may include consolidation of 
individual services into bundled codes for payment under the physician 
fee schedule.
b. Progress in Identifying and Reviewing 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 authorized by statute over the 
coming years. As part of our current process, we identify potentially 
misvalued codes for 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 its 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.
    Since CY 2009, as a part of the annual potentially misvalued code 
review and Five-Year Review process, we have reviewed over 1,250 
potentially misvalued codes to refine work RVUs and direct PE inputs. 
We have assigned appropriate work RVUs and direct PE inputs for these 
services as a result of these reviews. A more detailed discussion of 
the extensive prior reviews of potentially misvalued codes is included 
in the CY 2012 PFS final rule with comment period (76 FR 73052 through 
73055). In the CY 2012 final rule with comment period, 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-valued codes''). In CY 2009, we requested recommendations 
from the RUC to aid in our review of Harvard-valued codes that had not 
yet been reviewed, focusing first on high-volume, low 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 annual utilization of greater 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 misvalued. In addition to the Harvard-valued 
codes, in the CY 2013 final rule with comment period we finalized for 
review a list of potentially misvalued codes that have stand-alone 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 to 
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 services furnished in a 
nonfacility setting when the nonfacility PFS payment for a given 
service exceeds 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 final rule with comment period.
c. Validating RVUs of Potentially 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, mental effort and professional judgment, 
technical skill and physical effort, and stress due to risk) 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 validation, to validate a sampling of the work RVUs of 
codes identified through any of the 16 categories of potentially 
misvalued codes specified in section 1848(c)(2)(K)(ii)of the Act. 
Furthermore, the Secretary may conduct the validation using methods 
similar to those used to review potentially misvalued codes, including 
conducting surveys, other data collection activities, studies, or other 
analyses as the Secretary determines appropriate to facilitate the 
validation of RVUs of services.
    In the CY 2011 PFS proposed rule (75 FR 40068) and CY 2012 PFS 
proposed rule (76 FR 42790), we solicited public comments on possible 
approaches, methodologies, and data sources that we should consider for 
a validation process. We provided a summary of the 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 comment period (76 FR 73054 
through 73055).
    We contracted with two outside entities to develop validation 
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 contracted with the Urban Institute 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 estimates. 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

[[Page 67575]]

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 encountered in collecting objective time data and offers 
some thoughts on how these can be overcome. This interim report is 
available on the CMS Web site at http://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/PhysicianFeeSched/Downloads/RVUs-Validation-UrbanInterimReport.pdf. Collection of time data under this project has 
just 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 initial work RVUs and to identify potentially misvalued 
procedures under current CMS and RUC processes. RAND will use a 
representative set of CMS-provided codes to test the model. RAND 
consulted with a technical expert panel on model design issues 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 Web site.
    Descriptions of both projects are available on the CMS Web site at 
http://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/PhysicianFeeSched/Downloads/RVUs-Validation-Model.pdf.
    We acknowledge comments received regarding the Urban Institute and 
RAND projects, but note that we did not solicit comments on these 
projects because we made no proposals related to them. Any changes to 
payment policies 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 finalized and implemented.
3. CY 2015 Identification and Review of Potentially Misvalued Services
a. Public Nomination of Potentially Misvalued Codes
    In the CY 2012 PFS final rule with comment period, 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 documentation for 
codes nominated for the annual review of potentially misvalued codes 
may include the following:
    <bullet> Documentation in the peer reviewed medical literature or 
other reliable 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.
    <bullet> An anomalous relationship between the code being proposed 
for review and other codes.
    <bullet> Evidence that technology has changed physician work, that 
is, diffusion of technology.
    <bullet> Analysis of other data on time and effort measures, such 
as operating room logs or national and other representative databases.
    <bullet> 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.
    <bullet> Prices for certain high cost supplies or other direct PE 
inputs that are used to determine PE RVUs are inaccurate and do not 
reflect current information.
    <bullet> Analyses of work time, work RVU, or direct PE inputs using 
other data sources (for example, VA NSQIP, STS National Database, and 
the PQRS databases).
    <bullet> National surveys of work time and intensity from 
professional and management societies and organizations, such as 
hospital associations.
    After we receive the nominated codes during the 60-day comment 
period following the release of the annual PFS final rule with comment 
period, we evaluate the supporting documentation and assess whether the 
nominated codes appear to be potentially misvalued codes appropriate 
for review under the annual process. In the following year's PFS 
proposed rule, we publish the list of nominated codes and indicate 
whether we are 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 documentation for two of the nominated codes 
to ascertain whether the submitted 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 apologize for this oversight and will address the nomination of CPT 
codes 92227 and 92228 in the proposed rule for CY 2016.
    We proposed CPT code 41530 (submucosal ablation 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 this code as potentially 
misvalued thanked CMS for proposing this code as potentially misvalued, 
but indicated that the RUC had made recommendations for this code for 
CY 2015 and further review was no longer necessary. Another commenter 
suggested that this code should be removed from the list of potentially 
misvalued codes since it saves Medicare millions of dollars per year.
    Response: The RUC only provided us with recommendations for PE 
inputs for CPT code 41530. Under our usual process, we value work and 
PE at the same time and would expect to receive RUC recommendations on 
both before we revalue this service. We disagree with the commenter's 
statement that codes that may save money for the Medicare program 
should not be considered as potentially misvalued. 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 misvalued, because it is a non-covered 
service, and we only consider nominations of active codes that are 
covered by Medicare at the time of the nomination (see 76 FR 73059).
    Comment: Commenters did not disagree with CMS not proposing this 
code as potentially misvalued, but did raise a variety of comments 
about the code that were unrelated to our proposal.
    Response: We continue to believe that our policy to limit the 
designation of potentially misvalued to those codes that are covered by 
Medicare 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

[[Page 67576]]

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 majority 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 allowed 
charges. We excluded those codes that we have reviewed since CY 2009, 
those codes with fewer 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 explained 
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 direct 
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 relativity of the codes 
is essential to ensure that the work and PE RVUs are appropriately 
relative within the specialty and across specialties, as discussed 
previously. For these reasons, we proposed the codes listed in Table 11 
as potentially misvalued.

    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.
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 wound.
------------------------------------------------------------------------

    Comment: Many commenters disagreed with the 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 misvalued. Specifically, commenters explained that 
many of the services are highly utilized because of the 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 reported. 
Another commenter urged CMS to work with the RUC to ensure that the 
code lists identified 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 expressed 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 values 
are inaccurate, so that specialty societies do not have to go through 
the work of reviewing them.
    Several commenters questioned the statutory authority for CMS's 
proposal. One commenter questioned CMS's authority under the relevant 
statute to select potentially misvalued codes by specialty. The 
commenter stated that identifying the top 20 codes 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 majority of spending under the PFS, but does not 
provide for the identification of codes by specialty. The commenter 
said that a more direct interpretation of the statutory 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. Another 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 management (E/M) codes, which CMS excluded from review. 
The commenter said that if CMS believes that E/M services should not be 
reviewed--a position the commenter said they would certainly 
understand--then such a determination is sufficient to meet the 
statutory mandate to review codes accounting for the majority of PFS 
spending, and it would then be

[[Page 67577]]

appropriate for CMS and the RUC to focus efforts on other categories of 
potentially misvalued codes. The commenter urged CMS at the very least 
to develop a more targeted list of potentially misvalued 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 screens are intended to 
identify 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 limited resources 
on categories of codes where there is a high risk of significant 
payment distortions. One goal is to avoid perpetuating payment for the 
services at a rate that does not appropriately reflect the relative 
resources involved in furnishing the service. In implementing this 
statutory provision, we consider whether the codes meeting the 
screening criteria have a significant impact on payment for all PFS 
services due to the budget neutral nature of the PFS. That is, if codes 
meeting the screening criteria are indeed misvalued, they would be 
inappropriately impacting the relative values of all PFS services. 
Addressing included codes therefore indirectly addresses other 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 utilization have 
varying causes and do not necessarily reflect misvalued codes. However, 
we continue to believe that the high expenditure screen is nevertheless 
an appropriate means of focusing our reviews, ensuring appropriate 
relativity among PFS services, and identifying services that are either 
over or undervalued. The high expenditure screen is likely to identify 
misvalued 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 
specialty level, therefore a review of the relativity of the codes is 
essential to ensure that the work and PE RVUs are appropriately 
relative within the specialty and across specialties. We mentioned in 
the CY 2012 final rule with comment period how stakeholders have noted 
that many of the services previously identified under the potentially 
misvalued codes initiative were concentrated in certain specialties. To 
develop a robust and representative list of codes for review, we 
examine the highest PFS expenditure services by specialty and we 
identify those codes that have not been 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, 
and 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 
account for significant volume under the PFS, but there are significant 
issues with reviewing these codes as discussed in the CY 2012 final 
rule with comment period, and as a result we did not propose to include 
these codes as potentially misvalued.
    Comment: Some commenters suggested other screens that could be used 
to identify misvalued codes. In addition, even though our proposal 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 consider 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-value them if they were finalized as 
potentially misvalued.
    Comment: Several commenters requested that 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 revised process for 
reviewing new, revised, and potentially misvalued codes will improve 
the transparency of the PFS code review process, we do not believe it 
is appropriate to postpone the review of all potentially misvalued 
codes until the new process is implemented. We note that the codes 
identified in this rule as potentially misvalued would be revalued 
under the new process, which will be phased in starting for CY 2016 and 
will apply for all codes revalued for CY 2017.
    Comment: Commenters raised several codes that they believed should 
not be included in the high expenditure screen for a variety of 
reasons, for example if the code is related to other codes that were 
recently reviewed and the utilization 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' suggestion that we exclude 
particular codes from the screen, but since we are not finalizing a 
particular list of codes for this screen in this final rule we are not 
addressing these at this time. We note 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 
that only when these codes are either deleted or revised, and/or we 
receive new RUC recommendations 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 already 
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 avoidance of invasive procedures.
    Response: We acknowledge that certain types of procedures have been 
identified through multiple screens; however, we continue to believe 
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 already been reviewed. We 
further note that the presence of codes on the MPC list makes the case 
for their review more compelling, given their importance in ensuring 
overall relativity throughout the PFS. With respect to changes in PE 
RVUs, we note that cross-cutting 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 potentially misvalued does not imply

[[Page 67578]]

that the service itself is not of inherent value; rather, that its 
valuation may be inaccurate in either direction.
    After considering the comments received, as well as the other 
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 several 
years to revalue the services with global periods, we believe it is 
best to concentrate our efforts on these valuations. Therefore, we are 
not finalizing the codes identified through the high expenditure screen 
as potentially misvalued at this time. Also, we are not responding 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 time the 
specific set of codes to be reviewed that meet the high expenditure 
criteria.
(2) Epidural Injection and Fluoroscopic Guidance--CPT Codes 62310, 
62311, 62318, 62319, 77001, 77002 and 77003
    For CY 2014, we established interim final rates for four epidural 
injection procedures, CPT codes 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), 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)), 62318 
(Injection(s), including indwelling 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) and 62319 (Injection(s), including indwelling 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)). 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 substantial decrease in 
time it takes to furnish these services as reflected in the RUC survey 
data 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 objecting to the CY 2014 
interim final values for these codes, we looked at other injection 
procedures. Other injection procedures, including some that commenters 
recommended we use to value these epidural injection codes, include the 
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 the injection CPT code. Since our analysis of the 
Medicare data and comments received on the CY 2014 final rule with 
comment period indicated that these services are typically furnished 
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 epidural 
injection codes can be appropriately valued without considering the 
image 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 for the combined 
codes, we indicated that we believed more information is needed. 
Accordingly, 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 specifically related to 
image guidance, such as the radiographic fluoroscopic room, are 
included in these proposed direct PE inputs for the epidural injection 
codes, we believed allowing separate reporting of the image guidance 
codes would overestimate the resources used in furnishing the overall 
service. To avoid this situation, we also proposed to prohibit the 
billing of image guidance codes in conjunction with these four epidural 
injection codes. We stated that we believed our two-tiered proposal to 
utilize CY 2013 input values for this family while prohibiting separate 
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 the injection and the image guidance.
    Comment: The commenters did not object to identifying these codes 
as potentially misvalued and generally agreed with our proposal 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. Other 
commenters suggested that we create both a bundled code and a stand-
alone epidural injection code.
    Response: We appreciate commenters' support for our proposal to 
bundle image guidance with the epidural procedures. As part of the 
review process, consideration can be given to how to best implement 
bundled codes.
    Comment: Other commenters expressed concern that the bundling 
approach CMS proposed to use until these codes are reviewed did not 
incorporate the work or time for fluoroscopy. Some requested that we 
add the payment 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 allow the image 
guidance codes to be separately billed until these services are 
revalued. Another commenter suggested that it may be premature to 
prohibit separate billing for image guidance, as there is considerable 
variation on the

[[Page 67579]]

use of fluoroscopic guidance between codes within this family.
    Response: We understand commenters' concerns about our proposal to 
prohibit separate billing for image guidance, and note that these 
concerns are part of the reason we are referring these codes to the RUC 
as potentially misvalued. However, given that significant resources are 
allocated to fluoroscopic guidance within the current injection codes, 
we do not believe it is appropriate to continue to allow the image 
guidance to be separately billed while we evaluate these epidural 
injection codes as potentially misvalued services.
    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 guidance in conjunction with these services.
(3) Neurostimulator Implantation (CPT Codes 64553 and 64555)
    We proposed CPT codes 64553 (Percutaneous implantation of 
neurostimulator electrode array; cranial nerve) and 64555 (Percutaneous 
implantation of neurostimulator electrode array; peripheral nerve 
(excludes sacral nerve)) as potentially misvalued after stakeholders 
questioned whether the codes included the appropriate direct 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 adequately 
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 potentially misvalued, we then 
review the inputs for the code. As a result of such review, 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 received, we are 
finalizing CPT codes 64553 and 64555 as potentially misvalued.
(4) Mammography (CPT Codes 77055, 77056, and 77057, and HCPCS Codes 
G0202, G0204, and G0206)
    Medicare currently pays for mammography services through both CPT 
codes, (77055 (mammography; unilateral), 77056 (mammography; 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 direct digital image, 
unilateral, all views)). The CPT codes were designed to be used for 
mammography regardless of whether film or digital technology is used. 
However, for Medicare purposes, the HCPCS G-codes were created to 
describe mammograms using digital technology in response to special 
payment rules for digital mammography included in the Medicare Benefit 
Improvements and Protection Act of 2000 (BIPA).
    The RUC recommended that CMS update the direct 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 the Medicare data with regard to the application of 
this policy to mammography confirmed that virtually 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 establish 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 discussion of this policy.) In addition, since the G-code 
values have not been evaluated 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 the potentially misvalued codes list, commenters had 
differing opinions. One commenter stated that the work RVUs for digital 
mammography are the 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 appropriately captures 
the practice expense 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-resource-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 resource-based PE 
methodology, not from the RUC review. Another commenter indicated that 
the RUC should not survey 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 
consider that three-dimensional (3D) mammography codes involve 
additional resources over the two-dimensional (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 that it is appropriate to review the work RVUs for 
these services. By including these codes on the potentially misvalued 
code list, we will have information to determine whether the current 
values are still appropriate. Finally, we anticipate that the survey 
results for the mammography codes will reflect the equipment that is 
typically used. We note that until these services are reviewed, we do 
not have adequate information to respond to the suggestion that the 
valuation for these services will be significantly reduced. However, we 
do acknowledge that the PE methodology 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 codes. We 
believe it is most appropriate to value the mammography code family 
together, and receipt of RUC recommendations on the other mammography 
codes will 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

[[Page 67580]]

technology has replaced analog mammography as typical, not all agreed 
that it was appropriate to delete G-codes and use the CPT codes. One 
commenter supported the deletion of the G-codes. Other commenters 
suggested that deletion of the G-codes was unnecessary. Another 
commenter stated that the coding system frequently reflects differences 
in approach 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 supported continuation of 
the G-codes asked us to delay implementation as they were concerned 
that other payers would not have time to update their requirements by 
January 1, 2015. Another commenter applauded CMS's decision to delete 
the G-codes.
    Response: In further consideration of this proposal, we discovered 
that while the CPT codes for diagnostic mammography apply to 
mammography, whether film or digital technology is used, the descriptor 
for the screening mammography CPT code specifically refers to film. In 
light of this and that fact that we anticipate revaluing these codes 
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 consider 
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, G0204, 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 Medicare 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 elsewhere in this final rule with 
comment period, we believe that accurate valuation incentivizes 
appropriate utilization of services.
    After consideration of public comments, we are modifying our 
proposal 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 descriptor 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 abdominal aortic aneurysm (AAA) 
ultrasound screening, HCPCS code G0389 (Ultrasound, B-scan and/or real 
time with image documentation; for abdominal aortic aneurysm (AAA) 
screening) in CY 2007, we set 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 comment 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 code 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 applicability 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 RVUs 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 
accurately reflect the resources involved in furnishing the service. We 
sought recommendations from the public and other stakeholders, 
including the RUC, regarding the appropriate work RVU, time, direct PE 
input, and malpractice risk factors that reflect the typical resources 
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 section II.C of this final rule with comment 
period. We stated that we believe this valuation would ameliorate the 
effect of the CY 2014 reduction that resulted from the RVUs for G0389 
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 assign the 2013 PE RVUs 
until this procedure is reviewed.
    Comment: Many commenters supported our proposal to include this 
service on the potentially misvalued codes list. Some commenters agreed 
that the crosswalk used to set rates for this service does not appear 
to be appropriate at this time, whether 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 Category I CPT 
code for this service. Another commenter suggested that CMS consider 
crosswalking G0389 to CPT code 93979 (Duplex scan of aorta, inferior 
vena cava, iliac vasculature, or bypass grafts; unilateral or limited 
study). One commenter believed it was unnecessary to survey this code, 
but recommended 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 are unsure of the correct valuation. 
Therefore, we believe it is most appropriate to retain the 2013 inputs 
until we receive new recommendations, rather than making another change 
or retaining 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 descriptors 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. The CY 2014 descriptions are:

[[Page 67581]]

    <bullet> G0416 (Surgical pathology, gross and microscopic 
examination for prostate needle biopsies, any method; 10-20 specimens).
    <bullet> G0417 (Surgical pathology, gross and microscopic 
examination for prostate needle biopsies, any method; 21-40 specimens).
    <bullet> G0418 (Surgical pathology, gross and microscopic 
examination for prostate needle biopsies, any method; 41-60 specimens).
    <bullet> G0419 (Surgical pathology, gross and microscopic 
examination for prostate needle biopsies, any method; greater than 60 
specimens).
    Subsequently, we have discussed prostate biopsies with 
stakeholders, and reviewed medical literature and Medicare claims data 
in considering how best to code and value prostate biopsy pathology 
services. After considering these discussions and information, we 
believed it would be appropriate to use only one code to report 
prostate biopsy pathology services. Therefore, we proposed to revise 
the descriptor for G0416 to define 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 services, 
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 believe 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 evaluated 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 potentially misvalued code for 
CY 2015 and sought public comment on the appropriate work RVUs, work 
time, and direct PE inputs.
    Comment: One commenter supported the elimination of the G-codes as 
a means of simplifying coding requirements, but other commenters 
opposed our proposal 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 commenters 
suggested that we retain the current codes so that biopsy procedures 
requiring more than 10 specimens can be reimbursed accurately, and 
indicated that consolidating the coding would further confuse 
physicians and their staff who have not yet adapted to the CY 2014 
coding changes for these G-codes. Other commenters asserted that these 
changes threaten to undermine access to high quality pathology 
services. Commenters also stated 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 potentially misvalued, 
commenters stated that the recent change to these codes has already 
been confusing and suggests that there is not a clear understanding of 
what these codes 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 what 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 would be most accurate to 
utilize CPT code 88305 (Level IV--surgical pathology, gross 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 final rule, the 
commenters indicated that they believe that the agency's intent to 
establish straightforward coding and accurate payment for these 
services would be realized with this approach.
    Response: Given that the typical analysis of prostate biopsy 
specimens differs significantly from the typical analyses reported 
using CPT code 88305, as regards the number of blocks used to process 
the specimen and thus the 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 revalued with the understanding that prostate biopsies are billed 
separately, we believe that allowing CPT code 88305 to be reported in 
multiple units for prostate biopsies would account 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 codes list, to 
modify the descriptor to reflect all prostate biopsies, 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 counseling for obesity, 15 minutes) for reporting and 
payment of individual behavioral counseling for obesity. Coverage 
requirements specific to this service are delineated in the Medicare 
National Coverage Determinations Manual, Pub. 100-03, Chapter 1, 
Section 210, available at http://www.cms.gov/manuals/downloads/ncd103c1_Part4.pdf.
    It was brought to our attention that behavioral counseling for 
obesity is sometimes furnished in group sessions, and questions were 
raised about whether group sessions could be billed using HCPCS code 
G0447. To improve payment 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 (Face-to-face 
behavioral counseling for obesity, group (2-4), 30 minutes) and GXXX3 
(Face-to-face behavioral counseling 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 furnishing these services would report the relevant 
group code for each beneficiary participating in a group therapy 
session.
    Since we believed that the face-to-face behavioral 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 beneficiary receiving the service, 
the work RVUs and work time that we proposed for these codes were based 
upon the assumed typical number of beneficiaries per session, 4 and 9, 
respectively. Accordingly, we proposed

[[Page 67582]]

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 
the direct PE inputs for GXXX2 and GXXX3 currently included for G0447 
prorated to account for the differences in time and number of 
beneficiaries, and to crosswalk the malpractice 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 the proposed values for HCPCS codes GXXX2 and GXXX3.
    Comment: Commenters generally supported our proposal to establish a 
separate payment mechanism for obesity behavioral group counseling 
services, but raised 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 
for two G-codes when group counseling services under the PFS are 
generally billed with a single G-code. 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 access. 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 commenters' support for our proposal 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 group obesity counseling and crosswalk the work RVU and 
work time from the MNT group code. The individual code for 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 the 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-
face 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 before and after the procedure (56 FR 59502). For each of 
these 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 global packages that are 
labeled based on the number of post-operative days included in the 
global period: 0-day; 10-day; and 90-day. The 0-day global codes 
include the surgical procedure 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 addition, 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-operative services 
furnished one day prior to the procedure and post-operative services 
during the 90 days immediately following the day of the procedure.
    Section 40.1 of the Claims Processing Manual (Pub. 100-04, Chapter 
12 Physician/Nonphysician Practitioners) defines the global surgical 
package to include the following services when furnished during the 
global period:
    <bullet> 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;
    <bullet> Intra-operative Services--Intra-operative services that 
are normally a usual and necessary part of a surgical procedure;
    <bullet> Complications Following Surgery--All additional medical or 
surgical services required of the surgeon during the postoperative 
period of the surgery because of complications that do not require 
additional trips to the operating room;
    <bullet> Postoperative Visits--Follow-up visits during the 
postoperative period of the surgery that are related to recovery from 
the surgery;
    <bullet> Postsurgical Pain Management--By the surgeon;
    <bullet> Supplies--Except for those identified as exclusions; and
    <bullet> Miscellaneous Services--Items such as dressing changes; 
local incisional care; removal of operative pack; removal of cutaneous 
sutures and staples, lines, wires, tubes, drains, casts, and splints; 
insertion, irrigation and removal of urinary catheters, routine 
peripheral intravenous lines, nasogastric and rectal tubes; and changes 
and removal of tracheostomy tubes.
b. Concerns With the 10- and 90-Day Global Packages
    CMS supports bundled payments as a mechanism to incentivize high-
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 services to hospitals under the 
inpatient and outpatient prospective payment systems, the practical 
reality is that these global codes function significantly differently 
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 diversity 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 arrangements used by Medicare 
practitioners, and the care needs of Medicare beneficiaries. Despite 
these changes, the basic structures of the global surgery packages are 
the same as the packages that existed prior to the creation of the 
resource-based relative value system in 1992. Another significant 
difference between this and other typical models of bundled payments is 
that the payment rates for the global surgery packages are not updated 
regularly based on any reporting of the actual costs of patient care. 
For example, the hospital inpatient and outpatient prospective payment 
systems (the IPPS and OPPS, respectively) derive payment rates from 
hospital cost and charge data reported through annual Medicare 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 consistently updated data, over 
time, payment rates adjust to reflect the average resource costs of 
current practice. 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 global 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 series of concerns 
regarding the accuracy of payment for 10- and 90-day global codes, 
including: The fundamental difficulties in establishing

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appropriate relative values for these packages, the potential 
inaccuracies in the current information used to price global codes, the 
limitations on appropriate pricing in the future, the potential for 
global packages to create unwarranted payment differentials among 
specialties, the possibility that the current codes are incompatible 
with current medical practice, and the potential for these codes to 
present obstacles 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 payments 
for multiple services, or payment for episodes of care over a period of 
time. However, in the case of the post-operative portion of the 10- and 
90-day global codes, we believe that together 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 Post-Operative Days
    In general, we face many challenges in valuing PFS services as 
accurately as possible. However, the unique nature of global surgery 
packages with 10- and 90-day post-operative periods presents additional 
challenges distinct 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 individual service unlike other payment 
systems that rely on actual data on the costs 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 the 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 
other 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 
associated 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 Medicare payment made to individual 
practitioners. The RVUs of the individual global service codes are 
skewed whenever 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 prospective payment systems, such 
inaccuracies under the PFS are not corrected over time through a 
ratesetting process that makes year-to-year adjustments based on data 
on actual costs. For example, if a 90-day global code is valued based 
on an assumption or survey response that ten post-operative visits is 
typical, but practitioners reporting the code in fact typically only 
furnish six visits, then the resource assumptions are overestimated by 
the value of the four visits multiplied by the number of the times the 
procedure code is reported. In contrast, when our assumptions are 
incorrect about the typical resources involved in furnishing a PFS code 
that describes a single service, any inaccuracy 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 individual 
service. Such a variation between the assumptions used in calculating 
payment rates and the actual resource costs could be corrected if the 
payments for packaged services were updated regularly using data on 
actual services furnished. Medicare's prospective payment systems 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 the current PFS methodology, the global 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 visits, 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 visits 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 
individual Medicare beneficiaries, depending on individual 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 and 
level of services included 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 particular 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 only reporting and being paid 
for a specific service furnished on a particular date.
    For most PFS services, any difference between 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 typical case and the actual resources involved in 
furnishing the single specific service. When the 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 involved in 
furnishing an individual service. The converse is true if the RVUs for 
the global surgical package are based on fewer or a lower level of 
services than are typically furnished for a particular code.
(2) Questions Regarding Accuracy 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 global codes may not reflect the typical number and level of 
post-operative E/M visits actually furnished.
    In 2005, the OIG examined whether global surgical packages are 
appropriately valued. In its report on eye and ocular surgeries, 
``National Review of Evaluation and Management Services Included in Eye 
and Ocular Adnexa Global Surgery Fees for Calendar Year 2005'' (A-05-
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 the 
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 OIG identified the number of face-
to-face services recorded in the medical record, but did not review the 
medical necessity

[[Page 67584]]

of the surgeries or the related E/M services. The OIG concluded that 
the RVUs for these 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 the 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 report entitled ``Musculoskeletal Global Surgery Fees Often 
Did Not Reflect the Number of Evaluation and Management Services 
Provided'' (A-05-09-00053). For this investigation, the OIG sampled 300 
musculoskeletal global surgeries and again found that, for the majority 
of sampled surgeries, physicians furnished fewer E/M services than were 
included as part of the 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 higher 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 payments to 
reflect the number of E/M services that are actually being furnished. 
However, since it is not necessary under our current global surgery 
payment policy for a surgeon to report the individual E/M services 
actually 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 level 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 
summarized 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 comment solicitation, some commenters urged us to 
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 global periods reflected the typical case. Others 
suggested that we should conduct new surveys using the RUC approach or 
that we should mine hospital data to identify the typical number of 
visits furnished. Some comments suggested eliminating the 10- and 90-
day global codes.
(3) Limitations on Appropriate Future Valuations 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 service assumptions or changes to the number of post-surgery 
visits) have been difficult and controversial. 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 
procedure itself) and the number of included post-operative visits in 
the existing values is not always clear. Some services with global 
periods have been valued by adding the work RVU of the surgical 
procedure and all pre- and post-operative E/M services included in the 
global 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 correlation to the time and intensity values for the 
individual service components. Although 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 level 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 straightforward. Furthermore, 
we believe it would be important to frequently update the data on the 
number and level of visits 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.
(4) Unwarranted Payment Disparities
    Subsequent to our last comment solicitation regarding the valuation 
of the post-operative periods (77 FR 68911 through 68913), some 
stakeholders have raised concerns that global surgery packages 
contribute to unwarranted payment disparities between practitioners who 
do and do not furnish these services. These stakeholders have addressed 
several 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 regardless of whether the services are actually 
furnished, while practitioners who do not furnish global procedures 
with post-operative visits are only paid for 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 post-
operative visits. Although we have policies to address the situation 
when post-operative care is transferred from one practitioner to 
another, the beneficiary might simply choose to seek care from another 
practitioner without a formal transfer of care. The 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 would 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 services than 
reflected in the Medicare payment. Practitioners who do not furnish 
global surgery services 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 payment disparities can contribute to differences in 
aggregate RVUs across specialties. Since the RVUs are intended to 
reflect differences in the relative resource costs involved in 
furnishing a service, any disparity between assumed and actual costs 
results not only in paying some practitioners for some services that 
are not furnished, it also skews relativity between specialties.
    Stakeholders have also pointed out that payment disparities can 
arise because E/M services reflected in global periods generally 
include higher PE values than the same services when billed separately. 
The difference in PE values between separately billed visits and those 
included in global packages result primarily from two factors that are 
both inherent in the PFS pricing methodology.
    First, there is a different mix of PE inputs (clinical labor/
supplies/equipment) included in the direct PE inputs for a global 
period E/M service and a separately billed E/M service. For example, 
the clinical labor inputs for separately 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 staff type ``RN'' (L051A) priced at a higher rate of $0.51 
per minute. For these codes, the higher resource cost

[[Page 67585]]

may accurately reflect the typical resource costs associated with those 
particular visits. However, the different direct PE inputs may drive 
unwarranted payment disparities among specialties who report global 
surgery codes with post-operative periods and those that do not. The 
only way to correct these potential discrepancies under the current 
system, which result from the specialty-based differences in resource 
costs, would be to include standard direct 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 
furnished E/M visits. This occurs because the range of specialties 
furnishing a particular 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 allocation of indirect PE to each code, a higher amount of indirect 
PE can be allocated to the E/M services that are valued as part of the 
global 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 indirect PE allocated across a wide range of 
specialties, which has the tendency to lower the amount of indirect PE. 
For practitioners who are paid for visits primarily through post-
operative periods, 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 the 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 outpatient visits occur in the higher-paid non-facility office 
setting, when many of these visits are likely to be furnished in 
provider-based departments, which would be paid at the lower, PFS 
facility rate if they were billable separately. As we note elsewhere in 
this final rule with comment period, we do not have data on the volume 
of physicians' services furnished in provider-based departments, but 
public information suggests that it is not insignificant and that it is 
growing. When these services are paid as part of a global package, 
there is no adjustment made based on the site of service. Therefore, 
even though the PFS payment for services furnished in post-operative 
global periods might include clinical labor, disposable supply, and 
medical equipment costs (and additional indirect PE allocation) that 
are incurred by the facility and not the practitioner reporting the 
service, the RVUs for global codes reflect all of these costs 
associated with the visits.
(5) Incompatibility of Current Packages With Current Practice and 
Unreliability of RVUs for Use in New Payment Models
    In addition to these issues, the 10- and 90-day 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 follow-up visits related to that 
procedure. In many cases, we believe that models of post-operative care 
are increasingly heterogeneous, particularly given the overall shift of 
patient care to larger practices 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 
implementing a number of new payment models, including those that focus 
on bundled payments to practitioners or payments for episodes of care. 
Therefore, we believe it is critical for us to ensure that the PFS RVUs 
accurately reflect the resource costs for individual PFS services 
instead of reflecting potentially skewed assumptions regarding the 
number of services furnished over a long period of time in the 
``typical'' case. To the extent that the 10- and 90-day global periods 
reflect inaccurate assumptions regarding resource costs associated with 
individual 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 rulemaking, 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 critical for 
the RVUs used to develop PFS payment rates reflect the most accurate 
resource 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 under our existing methodologies and with available data. As 
such, we do not believe that maintaining the post-operative 10-and 90-
day global periods is compatible with our continued 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 during global periods may vary greatly 
across Medicare practitioners and beneficiaries, we believe that 
continued valuation and payment of these face-to-face services as a 
multi-day package may skew relativity and create unwarranted payment 
disparities within PFS fee-for-service payment. We also believe that 
the resource based valuation of individual physicians' services will 
continue to serve as a critical foundation for Medicare payment to 
physicians, whether through the current PFS or in any number of new 
payment models. Therefore, we believe it is critical that the RVUs 
under the PFS be based as closely and accurately as possible on the 
actual resources involved in furnishing the typical occurrence of 
specific services.
    To address the issues discussed above, we proposed to retain global 
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. Medically 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 data 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:
    <bullet> Increase the accuracy of PFS payment by setting payment 
rates for individual services based more closely upon the typical 
resources used in furnishing the procedures;
    <bullet> Avoid potentially duplicative or unwarranted payments when 
a beneficiary receives post-operative care

[[Page 67586]]

from a different practitioner during the global period;
    <bullet> Eliminate disparities between the payment for E/M services 
in global periods and those furnished individually;
    <bullet> Maintain the same-day packaging of pre- and post-operative 
physicians' services in the 0-day global; and
    <bullet> 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 objective data on the 
number of E/M and other services furnished during the current post-
operative periods and use those data to inform both the valuation of 
particular services and the overall budget neutrality adjustments 
required to implement this proposal. We sought comment on the most 
efficient means of acquiring accurate data regarding the number of 
visits and other services actually being furnished by the practitioner 
during the current post-operative periods. 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 information on these services 
through claims submission may be the best approach, and we would 
propose such a collection through future rulemaking. However, we are 
also interested in alternatives. For example, we sought information on 
the extent to which individual practitioners or practices may currently 
maintain their own data on services furnished during the post-operative 
period, and how we might collect and objectively evaluate that data.
    We also sought comment on the best means to ensure that allowing 
separate payment of E/M visits during post-operative periods does not 
incentivize otherwise unnecessary 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 implementation but we also 
solicited 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 possibility 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 reporting 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 allow 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 approach 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 different amounts of PE 
RVUs than separately reportable visits and would continue to provide 
incentives to some practitioners to minimize patient visits. 
Additionally, it would not address the changes in practice patterns 
that we believe have been occurring whereby the physician furnishing 
the procedure is not necessarily the same physician providing the post-
procedure follow up.
    This alternative option would also rest extensively on the 
effectiveness of using the new data to revalue the codes accurately. 
Given the unclear relationship 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 extensive review of individual codes or families of codes 
by CMS and stakeholders, including the RUC. We believe the investment 
of resources for such an effort would be better made to solve 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 visits 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 misvalued through our 
potentially misvalued code process for review as 10- and 90-day 
globals. Inappropriate valuations 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, respectively), 
and thus, valuing them appropriately is critical to appropriate 
valuation and relativity 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 changes 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 that could be addressed 
through this approach would rapidly be out of date as medical practice 
continues to change. Therefore, such an approach would be only 
partially effective and would impede our ability to address other 
potentially misvalued codes.
    We sought stakeholder input on an accurate and 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 post-operative visits, within categories of 
codes and code families. However, we believe that once we collect those 
data, there is a wide range of possible approaches to the revaluation 
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 potentially misvalued code initiative has focused on several 
hundred, generally high-volume codes per year. This proposal requires 
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,

[[Page 67587]]

we believe that data regarding the number and level of post-service 
office visits can be used in conjunction with other methods of 
valuation, such as:
    <bullet> Using the current potentially misvalued code process to 
identify and value the relatively small number of codes that represent 
the majority of the volume of services that are currently reported with 
codes with post-operative periods, and then adjusting the aggregate 
RVUs to account for the number of visits and using magnitude estimation 
to value the remaining services in the family.
    <bullet> Valuing one code within a family through the current 
valuation process and then using magnitude estimation to value the 
remaining services in the family.
    <bullet> Surveying a sample of codes across all procedures to 
create an index 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 
sought input on the best approach to achieve this proposed transition 
from 10- and 90-day, to 0-day global periods, including the timing of 
the changes, the means for revaluation, and the most effective and 
least burdensome means to collect objective, representative data 
regarding the actual number 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 global 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 appropriate 
valuation of new, revised, or potentially misvalued 10- or 90-day 
global codes before implementation of this proposal.
    We received many comments regarding the proposed 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 specifically 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 supported the proposal, including 
commenters representing several medical specialty societies and several 
health systems. Many of these commenters agreed with the reasons 
presented in the proposal. These commenters agreed that the current 
structure of the global surgery codes prevents CMS from accurately 
valuing and paying for these services, even if CMS had necessary visit 
data available. Many commenters agreed that the current arrangement may 
lead to unwarranted payment disparities and that the current packages 
have not evolved with changes in practice and because of this, likely 
provide unreliable building blocks for 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 separately (unbundling). Otherwise, the 
payment rate for the entire bundle will be inaccurate.'' MedPAC urged 
CMS to finalize this proposal and plan to use the more accurate 
valuations to create more accurate bundles in the future.
    Response: We appreciate the commenters' support 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 the current payment construct 
of the PFS. We agree that achieving the agency's goal of greater 
bundling requires accurate valuation of component services in a 
surgical procedure.
    Comment: Some commenters, including several of those representing 
specialty societies, urged CMS to postpone finalization of the proposal 
pending the report 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 
impact of the change on Medicare beneficiaries and practitioners. 
However, based 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 significant 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 
further analysis by stakeholders will contribute to implementing the 
transition in a manner that accurately values and pays for PFS 
services. We believe that accurate valuation of services furnished to 
Medicare beneficiaries 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 concerns of 
those who urged a delay in finalizing or implementing the proposal. In 
addition, some commenters who opposed the proposal disputed our 
contention that the global periods contribute to unwarranted payment 
disparities, saying that the increased direct and indirect PE and MP 
RVUs for E/M services furnished in the global surgical post-operative 
periods accurately account for the increased PE and MP costs of 
practitioners who furnish these services 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 are impediments to implementation. The issues relating to 
valuation of global period E/M services using our PE methodology are 
just one of several important considerations that led us to propose 
transforming 10- and 90-day 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, Medicare remains 
committed to bundled payment as a mechanism for delivery system reform 
and we will continue to explore the best way to bundle surgical 
services, including alternatives to the 0-day global surgical bundle.
    Comment: Many commenters who opposed the 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 the same codes, the PE and MP RVUs for the 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 finalized. 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 costs involved in 
furnishing the typical

[[Page 67588]]

PFS service. In developing the proposal, we noted that by including a 
significant number of E/Ms in the global periods for surgical services, 
the PFS ratesetting methodology distinguishes these services from other 
E/Ms for purposes of developing PE and MP RVUs, potentially 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 practitioners are valued more 
generally as individual services, and values are not maintained 
separately from the work RVUs for E/Ms furnished by other 
practitioners. Therefore, we do not agree with commenters that Medicare 
should establish higher PE and MP values for E/M services furnished in 
the post-surgical period than for other E/M services.
    Comment: Several commenters suggested that CMS should not use the 
OIG reports to generalize its concerns about the provision of surgical 
care, because 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 
practitioners 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 furnished by 
particular specialties that the OIG reviewed are not generalizable to 
other global surgery services. Nor did the commenters 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 number of postoperative visits 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 
document medical visits that are occurring in the post-surgical period 
to be concerning. As a general matter, Medicare does not require 
documentation to support a billed service beyond information 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 practitioners following standard 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 continuity 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 where a surgeon would provide only the surgery and leave 
postoperative care to other 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 patients on a daily basis in the hospital and as needed 
on an outpatient basis during the recovery period.
    Response: We do not believe that the global surgical package was 
designed to ensure or allocate appropriate post-operative care among 
practitioners. Under Medicare's current global surgery policy, 
practitioners can agree on the transfer of care during the global 
period and, in such cases, modifiers are used in order to split the 
payment between the procedure and the post-operative care. We do not 
agree that global surgical packages obligate the surgeon to furnish 
some or all of the post-operative care. Global surgical 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 typical for purposes 
of valuing the global package; and as discussed above, we have not 
found that this is necessarily the case. Even if Medicare maintains the 
10- and 90-day global surgery packages, there would be no assurance 
that the surgeon, and not another practitioner, would furnish all or a 
certain amount of post-operative care (whether by the patient's choice 
of practitioner or otherwise). 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 beneficiaries irrespective of changes in 
the structure of payment for surgical services.
    Comment: Several commenters stated that if Medicare adopts a policy 
to pay for post-operative care using E/M codes rather than through 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 level E/M services than 
those 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 inaccurately valued or, if, 
under the proposed policy, practitioners who furnish these services 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 to revalue these services. As with every service, we 
expect physicians 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 eventual denial of payment to one or more of the 
postoperative care providers, based 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 are 
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 periods should be transformed to 0-day 
packages to accommodate heterogeneous models of care that optimize 
patient outcomes.
    Comment: One commenter recommended that CMS establish G-codes for 
three levels of post-operative visits furnished by the original surgeon 
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 within the global period by a 
physician other than the operating surgeon, for the same or similar 
diagnosis, in order to begin to understand what portion of

[[Page 67589]]

postoperative visits are being billed outside of the global period.
    The RUC informed CMS that it has identified several large hospital-
based physician group practices that internally use CPT code 99024 to 
report each bundled post-operative visit, and therefore data is already 
being captured for some Medicare providers. The RUC also suggested that 
CMS may have denied-claims data available for CPT code 99024 via the 
Medicare claims processing system. The RUC recommends that CMS work 
with it to explore the availability, usefulness, and appropriateness of 
these data from group practices and the CMS denied-claims dataset, in 
order to gather existing, objective data to validate the actual number 
of post-operative visits for 10-day and 90-day procedures. The RUC also 
suggested that CMS should consider reviewing Medicare Part A claims 
data to determine the length of stay for surgical services furnished in 
the inpatient acute care hospital setting.
    MedPAC stated that data collection could take several years, would 
be burdensome for CMS and providers, and may be inaccurate since 
providers would have little incentive to report each visit. 
Furthermore, MedPAC suggested that such data collection would be 
unnecessary since the current ratesetting methodology already assumes 
particular numbers of visits. MedPAC suggested that CMS should reduce 
the RVUs 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 revaluing 
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 postoperative 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 negative or other anomalous values 
for many of these codes, but asserted that codes with anomalous values 
might then be individually reviewed. MedPAC suggested that if specialty 
societies or the RUC believe that the new values for specific global 
codes are inaccurate, they could present evidence that the codes are 
misvalued to CMS, presumably through the potentially misvalued code 
public nomination process. MedPAC further 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 against the reverse-building block 
approach to revaluation. These commenters stated that backing out the 
bundled E/M services would be highly inappropriate and methodologically 
unsound since the services were not necessarily valued using a 
building-block methodology. Many of these commenters, including the 
RUC, stated that the amount of post-operative work included in the 
codes can only be appropriately surveyed, vetted, and valued by the 
RUC.
    Response: We appreciate the concerns of commenters regarding the 
difficulty of revaluing the global surgery codes 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 resulting 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 revaluation, 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 accurate valuation of surgical care. As noted above, we will 
continue to explore appropriate ways of bundling global surgical 
services.
    Comment: In general, commenters supporting the proposal also 
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 commenters objecting to, or 
articulating reservations about, the proposal urged CMS to slow its 
implementation. Some of these commenters suggested that the process 
used to establish the current values for these CPT codes is ideal and 
stated that it would take many years to value the many individual 
services using the same methodologies.
    The RUC stated that there are over 4,200 services within the PFS 
with a 10-day or 90-day global period, so the scope of the proposal is 
very large and the transition 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 percent 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 value services as 
accurately as possible. We note that most comments suggesting a delay 
in revaluation were based on a common underlying view that code-level 
review of the full set of services by the RUC based on practitioner 
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 approach 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 routinely makes annual recommendations regarding several hundred 
codes, and we acknowledge that thousands of services cannot be valued 
using the typical RUC process in one year. On the other hand we believe 
that there are other options for revaluing some of the global surgery 
codes as 0-day global packages, 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 proposed 
implementation dates. We also 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 proposed as potentially misvalued 
this year under the high expenditure screen. We continue to remain 
interested in other potential data sources for accurately valuing PFS 
services, especially the vast 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 approaches to the 
revaluation of the 10- and 90-day global services would require the 
kind of delay that was urged based on the assumption that the RUC 
survey approach would be used for all those services.
    Additionally, we request stakeholders, including the CPT Editorial 
Panel and the RUC, to consider the utility of establishing and 
maintaining separate coding and national Medicare RVUs for the many 
procedures that have little to no utilization in the Medicare 
population. For example, there are over 1,000 10-

[[Page 67590]]

and 90-day global 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-Medicare 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 expressed concerns that requiring 
beneficiary coinsurance for each follow-up visit could dissuade 
beneficiaries 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 paying 
separate coinsurance for follow-up care can cause patients to perceive 
the net payments as larger, given the frequency of payment required. 
These commenters stated that the magnitude of these problems might be 
directly proportionate to how sick the patient is.
    Response: We understand the concerns of the commenters, but do not 
agree that Medicare beneficiaries are unlikely to appreciate the 
difference between frequency of payment and overall financial 
liability. We also note that the significant majority of patient 
encounters with Medicare practitioners generate some degree of 
beneficiary liability. While liability could prompt the proportion of 
beneficiaries without secondary insurance 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-
operative care. We do acknowledge that surgeons may need to explain the 
importance 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 construction of a surgical bundle.
    Comment: Several commenters expressed concerns that the proposal 
would result in disjointed or inadequate care and/or disrupt surgical 
registry data. These commenters suggested that neither patients nor 
alternate providers are 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 post-operative care of a surgeon are likely to forgo 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 change 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.
    Comment: Several commenters expressed concerns over other Medicare 
payment policies related to surgical procedures. Some commenters stated 
that the current multiple procedure payment reduction policies 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 post-operative period. Other commenters noted that potential 
reductions in payment to surgeons to account for the reduced post-
operative period would negatively impact practitioners 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 regarding 
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 codes where these payment policies currently 
apply. We are especially interested in understanding why stakeholders 
do not believe the policies effective for the current 0-day global 
codes would not similarly 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 opposed 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 
providers. Other commenters urged CMS to consider that post-operative 
visits would be subject to the same documentation requirements and 
other scrutiny as other separately-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 administrative burden on both CMS and 
practitioners who furnish these services in making the proposal. In 
both cases, we note the administrative burden would be no greater than 
the burden associated with the vast majority of other services paid 
through the Medicare PFS. We do not believe that the burden of 
separately reporting post-operative follow-up visits is particularly or 
unduly burdensome, given that most office visits paid through the PFS 
are separately reported under current Medicare policies. In comparison 
to the number of separately reported visits and other PFS services, the 
number of visits that likely occur in post-operative periods is 
relatively small. We do not agree that there are inherent reasons that 
medically necessary post-operative visits should 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 base 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 consider the possibility 
that there could be confusion among practitioners and payers if some 
payers continue to base payment on the 10- or 90-day post-operative 
periods.
    Response: We believe that payment policies 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 
stakeholders in developing our implementation strategy for the 
transition of 10- and 90-day global services to 0-day global services.
    Comment: Several commenters urged CMS to consult with stakeholders 
as we develop appropriate plans for the global period transition. These 
commenters cautioned that the structural reorganization of these 
services is challenging due to the large set of services that will be 
impacted and could potentially disrupt well-established payment for 
certain providers.
    Response: We appreciate these 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 transition and revalue all 
10- and 90-day global surgery services with 0-day global periods, 
beginning with the 10-day global services in CY 2017 and following with 
the 90-day global services in CY 2018. We note that as we

[[Page 67591]]

develop implementation details, including revaluations, we will take 
into consideration all of the comments we received to our global 
surgery proposal. We will provide additional 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-operative 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 revaluation of services as 0-day globals, we will actively assess 
whether there is a better construction of a bundled payment for 
surgical services.
    We also actively seek the analysis and perspective of all affected 
stakeholders regarding the best means to revalue these services as 0-
day global codes. We urge all stakeholders to engage with us regarding 
potential means of making 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 services and appropriate coding for post-
operative care. We remain committed to collecting objective data 
regarding the 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 Inherent Part 
of Furnishing the Procedure
    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 sedation. The work of 
moderate sedation has been included in the work RVUs for these 
diagnostic and therapeutic procedures based upon their inclusion in 
Appendix G. Similarly, the direct PE inputs for these 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 diagnostic or therapeutic service, 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 
appeared that practice patterns for endoscopic procedures were 
changing, with anesthesia increasingly being separately reported for 
these procedures. For 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 occurring in the Medicare program. We found 
that, for certain types of procedures such as digestive surgical 
procedures, a separate anesthesia service is furnished 53 percent of 
the time. For some of these digestive surgical procedures, 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 Appendix G, and, in 
fact, the data suggested 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 
moderate sedation toward a separately billed anesthesia service was not 
universal. We found that it differed by the class of procedures, 
sometimes at the procedure code level, and continued to evolve over 
time. Due to the changing nature of medical practice in this area, we 
noted that we were considering establishing a uniform approach to 
valuation for all Appendix G services for which moderate sedation is no 
longer inherent, rather than addressing this issue at the procedure 
level as individual procedures are revalued.
    We sought public comment on approaches to address the appropriate 
valuation of these services. Specifically, we were interested in 
approaches 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 furnished 
and billed. To the extent that Appendix G procedure values are adjusted 
to no longer include moderate sedation, we requested suggestions as to 
how moderate sedation 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 existing policies for valuing moderate sedation as 
inherent in these procedures until we have the opportunity to assess 
and respond to the comments on the proposed rule on the overall 
valuation 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 part 
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 interim final values and establish CY 2015 inputs for the lower 
gastrointestinal procedures, many of which are also listed in Appendix 
G.

C. Malpractice Relative Value Units (RVUs)

1. Overview
    Section 1848(c) of the Act requires that each service paid under 
the PFS be comprised of three components: Work; PE; and malpractice 
(MP) expense. As required by section 1848(c) of the Act, beginning in 
CY 2000, MP RVUs are resource based. Malpractice RVUs for new codes 
after 1991 were extrapolated from similar existing codes or as a 
percentage of the corresponding work RVU. Section 1848(c)(2)(B)(i) of 
the 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 and 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 resource-based MP RVUs largely paralleled the process used in the CY 
2010 update. The calculation required using information on specialty-
specific MP premiums linked to a specific service based upon the 
relative risk factors of the various specialties that furnish a 
particular service. Because MP premiums vary by state and specialty,

[[Page 67592]]

the MP premium information were weighted geographically and by 
specialty. Accordingly, the proposed MP RVUs were based upon three data 
sources: CY 2011 and CY 2012 MP premium data; CY 2013 Medicare payment 
and utilization data; and CY 2015 proposed work RVUs and geographic 
practice cost indices (GPCIs).
    Similar to the previous update, we calculated the proposed MP RVUs 
using specialty-specific MP premium data because they represent the 
actual expense incurred by practitioners to obtain MP insurance. We 
obtained and used MP premium data from state 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 its data from 
state insurance departments. We used information obtained from MP 
insurance rate filings with effective dates in 2011 and 2012. These 
were the most current data available during our data collection 
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 million, mature, claims-made policies (policies covering 
claims made, rather than those covering services furnished, during the 
policy term). A $1 million/$3 million liability limit policy means that 
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 premium data to reflect 
mandatory surcharges for patient compensation funds (funds to pay for 
any claim beyond the statutory amount, thereby limiting an individual 
physician's liability in cases of a large suit) in states where 
participation in such funds is mandatory. We attempted to collect 
premium data representing at least 50 percent of the medical MP 
premiums paid.
    We included premium information for all physician and NPP 
specialties, and all risk classifications available in the collected 
rate filings. Most insurance companies provided crosswalks from 
insurance service office (ISO) codes to named specialties. We matched 
these crosswalks to Medicare primary specialty designations (specialty 
codes). 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.
    Although we collected premium data from all states and the District 
of Columbia, not all specialties had premium data in the rate filings 
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 premium 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 extreme variations in 
premium amounts that we found it to be unreliable. The range in premium 
amounts 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 crosswalked these 
specialties to allergy and immunology, the specialty with the lowest 
premiums for which we had sufficient and reliable data.
    Our proposed methodology for updating the MP RVUs conceptually 
followed the specialty-weighted approach, used in the CY 2010 update. 
The specialty-weighted approach bases the MP RVUs for a given service 
upon a weighted 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 the 
MP RVUs. We also continued to use the risk factor of the dominant 
specialty for rarely billed services (that is, when CY 2013 claims data 
reflected allowed services of less than 100).
    We proposed minor refinements for updating the CY 2015 MP RVUs as 
compared to the previous update. These refinements included calculating 
a combined national average surgical premium and risk factor for 
neurosurgery and neurology and updating the list of invasive cardiology 
service HCPCS codes (for example, cardiac catheterization and 
angioplasty) to be classified as surgery for purposes of assigning 
service level risk factors. Additionally, we proposed to classify 
injection procedures used in conjunction with cardiac 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 umbrella 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 data to 
reflect the change in non-surgical premiums for all specialties since 
the previous MP RVU update.
    As discussed in the CY 2015 proposed rule (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 propose an anesthesia adjustment for MP in the CY 2016 PFS 
proposed rule. We also requested comments 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 Web site. The report on MP RVUs for the 
CY 2015 proposed rule and the proposed MP premium amounts and specialty 
risk factors are accessible from the CMS Web site under the supporting 
documents section of the CY 2015 PFS proposed rule at http://www.cms.gov/PhysicianFeeSched/. A more detailed explanation 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.
    Comment: Two commenters supported our proposal to combine the 
surgical premium data for neurosurgery and neurology for establishing 
the surgical risk factor for neurosurgery.
    Response: We agree with the commenters and will finalize our 
approach for determining the surgical premium for neurosurgery as 
proposed. We will combine surgical premiums for neurology and 
neurosurgery to calculate 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 
calculating 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 would result in significant

[[Page 67593]]

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 all services, including ophthalmic services. Accordingly, the 
proposed MP RVU update reflects the use of updated MP premium data and 
risk factors by specialty and is not affected in any way by the 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 
resulted 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 mistake during the previous MP RVU 
update rather than a proposed change in methodology or the use of 
updated premium data. We do not believe that a previous error is 
sufficient justification 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 the application of our 
specialty weighted approach for calculating service level risk factors 
for surgical services. For instance, the same commenters that requested 
a 2-year phase in of the reduction to ophthalmology services also 
requested that we exclude optometry from calculating the risk factor 
for 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 optometrists are involved 
only during the pre- or post-procedure periods of ophthalmic surgery. 
Another specialty society stated that it appears that CMS's methodology 
for calculating service level 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 correct 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 surgical and non-surgical services . That is, we apply 
the risk factor(s) of all specialties involved with furnishing the 
surgical procedure to calculate service level risk factors and MP RVUs. 
For assistants at surgery, we discount the utilization to reflect his 
or her role in furnishing the surgical procedure. Although we agree 
that MP cost for the surgeon may not be affected by the surgical 
assistant's MP cost, we do not agree with the suggestion that 
assistants at surgery should be excluded from our specialty weighted 
approach for determining service level MP risk factors and MP RVUs for 
surgical services. We believe it is appropriate to apply the specialty 
risk factor(s) of all practitioners participating in and receiving a 
payment for the surgical 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 calculation of the service level risk factor, 
the resulting MP RVU would not reflect 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. The 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 
utilization file the weighted average that we use reflects only the 
proportion of the utilization 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 entire global service.
    Comment: We received two comments regarding how risk factors are 
assigned to existing services without Medicare utilization. The 
commenters stated 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 existing services without 
Medicare utilization. The commenters contend that ``it is inappropriate 
for a service to have fluctuating MP risk factors simply due to whether 
it is reported in Medicare claims data for a given year.'' The 
commenters requested that we crosswalk existing services without 
Medicare utilization to a recommended source code.
    Response: We used the most recently available Medicare claims data 
(that is, from CY 2013) to determine the service level risk factors, 
either based on the 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 without Medicare utilization as indicated by our most 
recently available claims data. In the absence of Medicare utilization 
we continue to believe that the most appropriate risk factor is the 
weighted average risk factor for all service codes. The proposed 
weighted average risk factor for all service codes was 2.11. Using the 
weighted average risk factor for all services effectively neutralizes 
the impact of updated MP premiums and risk factors for any specific 
specialty (or mix of specialties).
    Comment: The AMA and the RUC and other commenters agreed with the 
majority of our proposed claims based dominant specialty designations 
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 claims have been miscoded, resulting in 
erroneous specialty designations. One commenter stated that using the 
dominant specialty 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 factors, 
either based on the mix of practitioners furnishing the service, or in 
the case of low volume services, assigning the 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 low 
volume services, and therefore resulting in the need for a subjective 
review of some services in place of a complete reliance on claims data. 
To that end, we

[[Page 67594]]

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 pulmonary disease is the dominant specialty for 
HCPCS code 33622 (Reconstruction of complex cardiac 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 illustrated in Table 
12.

  Table 12--Low Volume Service Codes Where Assigned Specialty Used Rather Than Claims Based Dominant Specialty
----------------------------------------------------------------------------------------------------------------
                                                                 Claims based dominant
              HCPCS Code                   Short descriptor            specialty            Assigned specialty
----------------------------------------------------------------------------------------------------------------
25490................................  Reinforce radius.......  Otolaryngology.........  Orthopedic Surgery.
26556................................  Toe joint transfer.....  Pulmonary Disease......  Orthopedic Surgery.
31320................................  Diagnostic incision      Cardiology.............  Otolaryngology.
                                        larynx.
33620................................  Apply r&l pulm art       Anesthesiology.........  Cardiac Surgery.
                                        bands.
33621................................  Transthor cath for       Cardiology.............  Cardiac Surgery.
                                        stent.
33622................................  Redo compl cardiac       Pulmonary Disease......  Cardiac Surgery.
                                        anomaly.
33697................................  Repair of heart defects  Cardiology.............  Cardiac Surgery.
33766................................  Major vessel shunt.....  General Surgery........  Cardiac Surgery.
36261................................  Revision of infusion     General Practice.......  General Surgery.
                                        pump.
43341................................  Fuse esophagus &         Gastroenterology.......  Thoracic Surgery.
                                        intestine.
43350................................  Surgical opening         General Practice.......  General Surgery.
                                        esophagus.
49491................................  Rpr hern preemie reduc.  General Practice.......  General Surgery.
50686................................  Measure ureter pressure  Internal Medicine......  Urology.
54352................................  Reconstruct urethra/     Pediatric Medicine.....  Urology.
                                        penis.
54380................................  Repair penis...........  Gastroenterology.......  Urology.
61000................................  Remove cranial cavity    Family Practice........  Neurosurgery.
                                        fluid.
61558................................  Excision of skull/       Family Practice........  Neurosurgery.
                                        sutures.
61567................................  Incision of brain        Cardiology.............  Neurosurgery.
                                        tissue.
74710................................  X-ray measurement of     Thoracic Surgery.......  Diagnostic Radiology.
                                        pelvis.
96003................................  Dynamic fine wire emg..  Cardiology.............  Physical Therapist/
                                                                                          Independent Practice.
96420................................  Chemo ia push technique  Urology................  Hematology Oncology.
99170................................  Anogenital exam child w  Ophthalmology..........  Pediatric Medicine.
                                        imag.
99461................................  Init nb em per day non-  Cardiac                  Pediatric Medicine.
                                        fac.                     Electrophysiology.
----------------------------------------------------------------------------------------------------------------

    Comment: Some commenters requested that we crosswalk gynecological 
oncology to general surgery, instead of crosswalking to obstetrics/
gynecology because gynecological oncology is more akin to general 
surgery procedures 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.
    Comment: One commenter requested that we crosswalk clinical 
laboratory to pathology instead of the risk factor used for TC services 
because clinical laboratories and pathologists render essentially 
identical medical procedures that are paid on the Medicare PFS.
    Response: We believe that the MP risk for clinical 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, 
than to the MP risks for pathologists. The commenters did not provide 
sufficient rationale to support that MP risk for clinical laboratories 
is similar to the MP risk of pathologists. Therefore, we will crosswalk 
clinical laboratory to the TC risk factor as proposed.
    Comment: One commenter encouraged us to crosswalk the 
interventional pain management specialty to a specialty that more 
closely reflects the risks and services associated with interventional 
pain management, such as interventional radiology or a comparable 
surgical subspecialty.
    Response: We believe that the MP risk associated with 
interventional pain management is conceptually similar to the MP risk 
for anesthesiology more so than to the MP risk for interventional 
radiology. Given that the commenters did not provide sufficient 
rationale to support that MP risk for interventional pain management is 
similar to interventional radiology or to a comparable surgical 
specialty, we will crosswalk interventional pain management to 
anesthesiology as proposed.
    Comment: We received contrasting comments on our proposal to 
crosswalk NPPs to the premium and risk factor calculated for allergy/
immunology. For instance, one commenter acknowledged the difficulty in 
identifying comprehensive, 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 
risk factor, allergy/immunology. Another commenter, specifically 
supported crosswalking registered dieticians 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 the 
premium amounts and risk factor used for allergy/immunology. The 
commenters stated that allergy/immunology premiums overstate NPP 
premiums and requested that we use the generally 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 determine accurate MP premium risk 
factors for NPPs. Another commenter suggested that we work with the AMA

[[Page 67595]]

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 this 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 and 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 
crosswalks 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 for future 
updates. We will also explore other potential measures of central 
tendency for determining the ``indexed'' specialty as an alternative to 
using the premium values of the lowest specialty.
    Comment: We received two comments regarding the data and or 
methodology used to calculate the TC and PC of diagnostic services. One 
specialty group noted that the proposed MP RVUs for the TC of some 
diagnostic services increased while the MP RVUs for the PC decreased. 
Specifically, the commenter questioned why the MP RVUs for the PC of 
diagnostic cardiac catheterization as described by HCPCS codes 93451 
through 93461 decreased by 6 to 12 percent while the TC portion for 
these codes increased 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 ``50th percentile'' premium data for ``umbrella 
non-physician MP liability'' for calculating CY 2015 MP RVUs for TC 
services.
    Response: To calculate the risk factor for TC services we used the 
mean umbrella non-physician 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 services. However, given that the MP 
RVUs for TC services are generally low, any increase to the MP RVUs 
could 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 significant 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.
    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 current methodology for 
calculating the risk factor 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 alternatives to our current methodology for 
calculating the PC risk factor as part of our further study and would 
propose any changes through future rulemaking.
    Comment: Several commenters supported our proposal to classify 
cardiac catheterization and angioplasty services as surgical procedures 
for the purpose of establishing service level risk factors. The 
commenters also agreed with our proposal to apply the surgical 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 cardiology services. Specifically, the 
commenters requested that we consider adding HCPCS codes 92961, 92986, 
92987, 92990, 92992, 92993, 92997, and 92998 to the list of invasive 
cardiology procedures classified 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 associated 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 catheterization and angioplasty services 
as described by HCPCS codes 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 
risk factors. We note that HCPCS codes 92992 and 92993 are contractor-
priced codes, wherein the Medicare claims processing contractors 
establish RVUs and payment amounts for these services. Therefore, we 
are not adding HCPCS codes 92992 and 92993.
    Comment: One commenter stated that several 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 injection 
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 injection 
procedure codes mentioned by the commenter on the list of services 
outside of the surgical HCPCS code range to be considered surgery for 
purposes of assigning service level MP risk factors.
    Comment: One commenter questioned why 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 factor to invasive cardiology services outside of the 
surgical HCPCS code range should 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 cardiology 
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 these services. As discussed 
previously in this section, the service level risk factors reflect the 
average risk factor (weighted by allowed services) of the specialties 
furnishing a given service. Changes 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 
services attributed to cardiology decreased for these service codes 
while the percentage of allowed services furnished by other specialties 
with risk factors lower than cardiology, such as internal medicine 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 image guided breast 
biopsy procedures. The commenters

[[Page 67596]]

stated that given that the MP RVUs assigned to breast biopsy codes are 
being reduced, CMS is not appropriately capturing the risk a physician 
assumes when performing a procedure to diagnose cancer. Several 
commenters also explained that the 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 biopsy procedures as 
described 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 recommended that we implement an annual 
collection and review of MP premium data and rescale the MP RVUs each 
year, as we do with the PE RVUs. The commenters also stated that an 
annual 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, recalculation of 
specialty risk factors based upon updated premium data and 
recalculation of service level RVUs based upon the mix of practitioners 
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 services. 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 calculate risk factors for all 
specialties approved by the American Board Medical Specialties (ABMS) 
since 2010. The commenter stated that by using the approved ABMS 
specialties, all specialties 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 regarding our discussion of how 
to reflect updated MP premium data under the 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 component associated with anesthesia fee 
schedule services. Another commenter suggested using mean 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 premiums over a longer period 
of time renders the average more accurate and less volatile than a 
calculation over a 1-year period.
    Response: We appreciate the comments on our potential approach for 
updating the MP resource costs for anesthesia fee schedule services. We 
will consider the commenter's suggestions to use multi-year average 
premiums 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 the 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 factor 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 outside of the 
surgical HCPCS code range considered as surgery for purposes of 
assigning service level risk factors. Additionally, for determining the 
risk factor for low volume services, we are overriding the dominant 
specialty from our claims data with the recommended specialty 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 claims data. The MP premium 
amounts, specialty risk factors, and a complete list of service codes 
outside the surgical HCPCS code range considered surgery for the 
purpose of assigning service level risk factors, may be found on the 
CMS Web site under the supporting documents section 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 Web site. It is also 
located under the supporting documents section of the CY 2015 PFS final 
rule with comment period located at http://www.cms.gov/PhysicianFeeSched/.

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 (that 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 Act 
requires that the work GPCIs reflect only one-quarter of the relative 
cost differences compared to the national average. In addition, section 
1848(e)(1)(G) of the Act sets a permanent 1.5 work GPCI floor for 
services furnished in Alaska beginning January 1, 2009, and section 
1848(e)(1)(I) of the Act sets a permanent 1.0 PE GPCI floor for 
services furnished in frontier states (as defined 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 March 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 adjustment, 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 GPCIs 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 
GPCI adjustment in CY 2014. We also revised the cost share

[[Page 67597]]

weights that correspond to all three GPCIs in the CY 2014 PFS final 
rule with comment period. We calculated a corresponding geographic 
adjustment factor (GAF) for each PFS locality. The GAFs are a weighted 
composite of each area's work, PE and MP GPCIs using the national GPCI 
cost share weights. Although the GAFs are not used in computing the fee 
schedule payment for a specific service, we provide 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. 
Additionally, as required by sections 1848(e)(1)(G) and 1848(e)(1)(I) 
of the Act, the 1.5 work GPCI floor for Alaska and the 1.0 PE GPCI 
floor for frontier states are permanent, and therefore, 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 
used updated Bureau of Labor and Statistics Occupational Employment 
Statistics (BLS OES) data (2009 through 2011) as a replacement for 2006 
through 2008 data for purposes 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 American 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 insurance as a replacement for 2006 
through 2007 premium 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 geographic 
variation in relative costs. Additionally, we updated the GPCI cost 
share 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 comment period, use of the 
revised GPCI cost share weights changed the weighting of the 
subcomponents within the PE GPCI (employee wages, office rent, 
purchased services, and medical equipment 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 rule (79 FR 40355 through 
40356) the current methodology for calculating locality level GPCIs 
relies 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 locality. The Virgin Islands 
have county level equivalents identified as districts. Specifically, 
the Virgin Islands are divided into 3 districts: Saint Croix; Saint 
Thomas; and Saint John. These districts are, in turn, subdivided into 
20 sub-districts. Although the Virgin Islands are divided into these 
county equivalents, county level data for the Virgin Islands are not 
represented in the BLS OES wage data. Additionally, the ACS, which is 
used to calculate the rent component 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 absence 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.
    For CY 2015, we explored using the available 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, aggregate territory level BLS 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 current approach of assigning 
a value of 1.0. At our request, our contractor calculated 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 malpractice 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. However, 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 percent 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 component and purchased services component of the PE GPCI for the 
Virgin Islands 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. Therefore, 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 Final Report on the CY 2014 Update of the Geographic 
Practice Cost Index for the Medicare Physician Fee Schedule,'' which is 
available on the CMS Web site. It is located under the supporting 
documents section of the CY 2015 PFS final rule with comment period 
located at http://www.cms.gov/PhysicianFeeSched/.

[[Page 67598]]

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 request an increase in the 
GPCI values for the Puerto Rico payment locality. The commenters stated 
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 higher in Puerto 
Rico than many states and territories. Commenters contend that the data 
used to calculate GPCIs do not accurately reflect the cost of operating 
a medical practice in Puerto Rico.
    Response: Aside from proposing to use territory-wide wage data for 
the Virgin Islands payment locality, we finalized the methodology and 
values for the 7th GPCI update in the CY 2014 PFS final rule with 
comment period. We did not propose any changes to the GPCIs for the 
Puerto Rico payment locality, and the commenters on the CY 2015 PFS 
proposed rule raised the same issues they raised in response to the 
proposed GPCI update that we finalized in CY 2014. In the CY 2014 PFS 
final rule with comment period (78 FR 74380 through 74391), we 
summarized these comments and responded to these issues.
    Comment: A few commenters stated that GPCIs 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 requested that we replace 
the current method for calculating the work GPCIs with one that 
reflects the labor market for physicians and other health professionals 
as recommended by MedPAC. Another commenter raised questions about 
state patient compensation fund surcharges for malpractice insurance 
and the implications of those for the MP GPCI values. Additionally, we 
received a comment about the physician fee schedule payment localities.
    Response: As noted in this 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 territory-wide wage data for 
the Virgin Islands payment locality, we did not propose any further 
changes in the CY 2015 PFS proposed rule. We will consider these points 
raised by commenters when we develop a proposal for the 8th GPCI 
update.

E. Medicare Telehealth Services

1. Billing and Payment for Telehealth Services
    Several conditions must be met in order for Medicare payments to be 
made for telehealth services under the PFS. Specifically, the service 
must be on the list of Medicare telehealth services and meet all of the 
following additional requirements for coverage:
    <bullet> The service must be furnished via an interactive 
telecommunications system.
    <bullet> The practitioner furnishing the service must meet the 
telehealth requirements, as well as the usual Medicare requirements.
    <bullet> The service must be furnished to an eligible telehealth 
individual.
    <bullet> The individual receiving the services must be in an 
eligible originating site.
    When all of these conditions are met, Medicare pays an originating 
site fee to the originating site and provides separate payment to the 
distant site practitioner furnishing the service.
    Section 1834(m)(4)(F)(i) of the Act defines Medicare telehealth 
services to include consultations, office visits, office psychiatry 
services, 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 
process for annual updates to the list of Medicare telehealth services 
as required 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 Sec.  410.78(b), we generally require that a 
telehealth service be furnished via an interactive telecommunications 
system. Under Sec.  410.78(a)(3), an interactive telecommunications 
system is defined as multimedia communications equipment that includes, 
at a minimum, audio and video equipment permitting two-way, real-time 
interactive communication between the patient and distant site 
physician or practitioner.
    Telephones, facsimile machines, and electronic mail systems do not 
meet the definition of an interactive telecommunications 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'' technology when the 
originating site is part of a federal telemedicine demonstration 
program in Alaska or Hawaii. As specified in regulations at Sec.  
410.78(a)(1), store-and-forward means the asynchronous 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 furnished to an eligible 
telehealth individual notwithstanding the fact that the practitioner 
furnishing the telehealth service is not at the same location as the 
beneficiary. An eligible telehealth individual means an individual 
enrolled under Part B who receives a telehealth service furnished at an 
originating site.
    Practitioners furnishing Medicare telehealth services are reminded 
that these services are subject to the same non-discrimination laws as 
other services, including the effective communication requirements for 
persons with disabilities of section 504 of the Rehabilitation Act and 
language access for persons with limited English 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/hospitalcommunication.
    Practitioners furnishing Medicare telehealth services submit claims 
for telehealth services to the Medicare Administrative Contractors that 
process claims for the service area where their distant site is 
located. Section 1834(m)(2)(A) of the Act requires that a practitioner 
who furnishes a telehealth service to an eligible telehealth individual 
be paid an amount equal to the amount that the practitioner would have 
been 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 paid a fee under the PFS for each 
Medicare telehealth service. The statute specifies both the types of 
entities that can serve as originating sites and the geographic 
qualifications for originating sites. With regard to geographic 
qualifications, Sec.  410.78(b)(4) limits originating sites to those 
located in rural health professional shortage areas (HPSAs) or in a 
county that is not included in a metropolitan statistical areas (MSAs).
    Historically, we have defined rural HPSAs to be those located 
outside of MSAs. Effective January 1, 2014, we modified the regulations 
regarding

[[Page 67599]]

originating 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 expands access to health care 
services for Medicare beneficiaries located in rural areas. HRSA has 
developed a Web site tool to provide assistance to potential 
originating sites to determine their geographic status. To access this 
tool, see the CMS Web site at www.cms.gov/telehealth/.
    An entity participating in a federal telemedicine demonstration 
project that has been approved by, or received funding from, the 
Secretary 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 established and 
maintained on an annual basis, consistent with other telehealth payment 
policies (78 FR 74400). Geographic eligibility for Medicare telehealth 
originating sites for each calendar 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 payment 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 process, we assign any qualifying 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 category were finalized in the November 28, 2011 Federal 
Register (76 FR 73102). The two categories are:
    <bullet> Category 1: Services that are similar to professional 
consultations, office visits, and office psychiatry services that are 
currently on the list of telehealth services. In reviewing these 
requests, we look for similarities between the requested and existing 
telehealth services for the roles of, and interactions among, the 
beneficiary, the physician (or other practitioner) at the distant site 
and, if necessary, the telepresenter, 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.
    <bullet> Category 2: Services that are not similar to the current 
list of telehealth services. Our review of these requests includes an 
assessment of whether the service is accurately described by the 
corresponding code when furnished via telehealth and whether the use of 
a telecommunications system to deliver the service produces 
demonstrated clinical benefit to the patient. In reviewing these 
requests, we look for evidence indicating that the use of a 
telecommunications system in furnishing the candidate telehealth 
service produces clinical benefit to the patient. Submitted evidence 
should include both a description of relevant clinical studies that 
demonstrate the service 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 published peer reviewed articles 
relevant to the service when furnished via telehealth. Our evidentiary 
standard of clinical benefit does not include minor or incidental 
benefits.
    Some examples of clinical benefit include the following:
    <bullet> Ability to diagnose a medical condition in a patient 
population without access to clinically appropriate in-person 
diagnostic services.
    <bullet> Treatment option for a patient population without access 
to clinically appropriate in-person treatment options.
    <bullet> Reduced rate of complications.
    <bullet> Decreased rate of subsequent diagnostic or therapeutic 
interventions (for example, due to reduced rate of recurrence of the 
disease process).
    <bullet> Decreased number of future hospitalizations or physician 
visits.
    <bullet> More rapid beneficial resolution of the disease process 
treatment.
    <bullet> Decreased pain, bleeding, or other quantifiable symptom.
    <bullet> Reduced recovery time.
    For the list of covered telehealth services, see the CMS Web site 
at www.cms.gov/teleheath/. Requests to add services 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 service to the list of Medicare telehealth services 
must include any supporting documentation the requester wishes us to 
consider as we review 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 
information submitted is subject to public disclosure for this purpose. 
For more information on submitting a request for an addition to the 
list of Medicare telehealth services, including where to mail these 
requests, see the CMS Web site 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 
services on the existing telehealth list with respect to the roles of, 
and interactions among, the beneficiary, physician (or other 
practitioner) at the distant site and, if necessary, the telepresenter. 
As we stated in the CY 2012 final rule with comment period (76 FR 
73098), we believe that the category 1 criteria not only streamline our 
review process for publicly requested services that fall into this 
category, the criteria also expedite our ability to identify codes for 
the telehealth list that resemble those services already on this list.
a. Submitted Requests
    We received several requests in CY 2013 to add various services as 
Medicare telehealth services effective for CY 2015. The following 
presents 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 telehealth 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:
    <bullet> CPT codes 90845 (Psychoanalysis); 90846 (family 
psychotherapy (without the patient present); and 90847 (family 
psychotherapy (conjoint psychotherapy) (with patient present);
    <bullet> CPT codes 99354 (prolonged service in the office or other 
outpatient setting requiring direct patient contact beyond the usual 
service; first hour (list separately in addition to code for office or 
other outpatient evaluation and management service); and, 99355 
(prolonged service in the office or other outpatient setting requiring 
direct patient contact beyond the usual service; each additional 30 
minutes (list

[[Page 67600]]

separately in addition to code for prolonged service); and,
    <bullet> HCPCS codes G0438 (annual wellness visit; includes a 
personalized prevention plan of service (pps), initial visit; and, 
G0439 (annual 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:
    <bullet> CPT codes 92250 (fundus photography with interpretation 
and report); 93010 (electrocardiogram, routine ECG with at least 12 
leads; interpretation and report only), 93307 (echocardiography, 
transthoracic, real-time with image documentation (2d), includes m-mode 
recording, when performed, complete, without spectral or color Doppler 
echocardiography; 93308 (echocardiography, transthoracic, real-time 
with image documentation (2d), includes m-mode recording, when 
performed, follow-up or limited study); 93320 (Doppler 
echocardiography, pulsed wave and/or continuous wave with spectral 
display (list separately in addition to codes for echocardiographic 
imaging); 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 study 
(list separately in addition to codes for echocardiographic imaging); 
and 93325 (Doppler echocardiography color flow velocity mapping (list 
separately in addition to codes for echocardiography). These services 
include a technical component (TC) and a professional component (PC). 
By definition, the TC portion of these services needs to be furnished 
in the same location as the patient and thus cannot be furnished via 
telehealth. The PC portion of these services could be (and typically 
would be) furnished without the patient being present 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 only the PC 
portion of the service is being furnished, and other times the same CPT 
code is used with a -26 modifier to indicate that only the PC is being 
billed.) For example, the interpretation by a physician of an actual 
electrocardiogram or electroencephalogram 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 physicians' services in the same 
way as services that are furnished in-person without the use of 
telecommunications 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).
    <bullet> CPT codes 96103 (psychological testing (includes 
psychodiagnostic assessment of emotionality, intellectual abilities, 
personality and psychopathology, eg, MMPI), administered by a computer, 
with qualified health care professional interpretation and report); 
and, 96120 (neuropsychological testing (eg, Wisconsin Card Sorting 
Test), administered by a computer, with qualified health care 
professional interpretation and report). These services involve testing 
by computer, can be furnished remotely without the patient being 
present, and are payable in the 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.
    <bullet> 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, hematologic data); 99091 
(collection and interpretation of physiologic data (eg, ECG, blood 
pressure, glucose monitoring) digitally stored and/or transmitted by 
the patient and/or caregiver to the physician or other qualified health 
care professional, qualified by education, training, licensure/
regulation (when applicable) requiring a minimum of 30 minutes of 
time); 99358 (prolonged evaluation and management service before and/or 
after direct patient care; first hour); and 99359 (prolonged evaluation 
and management service before and/or after direct patient care; each 
additional 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.
    <bullet> CPT codes 96101 (psychological testing (includes 
psychodiagnostic assessment of emotionality, intellectual abilities, 
personality and psychopathology, eg, MMPI, Rorschach, WAIS), per hour 
of the psychologist's or physician's time, both face-to-face time 
administering tests to the patient and time interpreting these test 
results and preparing the report); 96102 (psychological testing 
(includes psychodiagnostic assessment of emotionality, intellectual 
abilities, personality and psychopathology, eg, MMPI and WAIS), with 
qualified health care professional interpretation and report, 
administered by technician, per hour of technician time, face-to-face); 
96118 (neuropsychological testing (eg, Halstead-Reitan 
Neuropsychological Battery, Wechsler Memory Scales and Wisconsin Card 
Sorting Test), per hour of the psychologist's or physician's time, both 
face-to-face time administering tests to the patient and time 
interpreting these test results and preparing the report); and, 96119 
(neuropsychological testing (eg, Halstead-Reitan Neuropsychological 
Battery, Wechsler Memory Scales and Wisconsin Card Sorting Test), with 
qualified health care professional interpretation and report, 
administered by technician, per hour of technician 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.
    <bullet> CPT codes 57452 (colposcopy of the cervix including upper/
adjacent vagina; 57454 colposcopy of the cervix including upper/
adjacent vagina; with biopsy(s) of the cervix and endocervical 
curettage); and, 57460 (colposcopy of the cervix including upper/
adjacent vagina; with loop electrode biopsy(s) of the cervix). These 
services are not similar to other services on the telehealth service 
list. Therefore, it would not be appropriate to add them on a category 
1 basis. 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.
    <bullet> HCPCS code M0064 (brief office visit for the sole purpose 
of monitoring or changing drug prescriptions used in the treatment of 
mental psychoneurotic

[[Page 67601]]

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 health 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 limitation 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 higher share of beneficiary coinsurance for these 
services than for most other Medicare services paid under the PFS. 
Effective January 1, 2014, 100 percent of expenses incurred for mental 
health treatment services 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 amended 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 those 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.
    <bullet> Urgent Dermatologic Problems and Wound Care--The American 
Telemedicine Association (ATA) cited several studies to support adding 
dermatology 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 services 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 office visit codes or the telehealth 
consultation G-codes.
    In summary, we proposed to add the following codes to the 
telehealth list on a category 1 basis:
    <bullet> Psychotherapy services CPT codes 90845, 90846 and 90847.
    <bullet> Prolonged service office CPT codes 99354 and 99355.
    <bullet> Annual wellness visit HCPCS codes G0438 and G0439.
3. Modifying Sec.  410.78 Regarding List of Telehealth Services
    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 addition of services to the 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 initiative and seek 
public comments on our proposals. After consideration of public 
comments, we finalize additions to the list in the final rule. We have 
also revised Sec.  410.78(b) each year to include the description of 
the added services. Because the list of Medicare telehealth services 
has grown quite lengthy, and given the other mechanisms by which we can 
make the public aware of the list of Medicare telehealth services for 
each year, we proposed to revise Sec.  410.78(b) by deleting the 
description of the 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 add to the list of 
telehealth 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 Sec.  410.78(f) to indicate that a list of 
Medicare telehealth codes and descriptors is available on the CMS Web 
site.
    The following is a summary of the comments 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 codes G0438 and G0439) to the list of Medicare 
telehealth services for CY 2015.
    Response: We appreciate the commenters' support 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 add these services to the list of telehealth services 
for CY 2015 on a category 1 basis.
    Comment: Commenters also agreed with our rationale for rejecting 
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 telehealth services. Another commenter objected to our 
proposal not to add psychological testing services to the telehealth 
services list.
    Response: As we noted in the proposed rule, the request to add 
dermatology services did not include specific codes. Without specific 
codes to consider, we cannot evaluate whether the services 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 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 store-and-forward technology as a telecommunication system for 
telehealth services only in the case of federal telemedicine 
demonstration programs in Alaska and Hawaii (see Sec.  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 counter-productive to add these codes to the telehealth list 
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 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.
    Finally, CPT codes 96101, 96102, 96118 and 96119 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.
    We received other public comments on matters related to Medicare 
telehealth services that were not the subject of proposals in the CY 
2015 PFS proposed rule. Because we did not make any proposals regarding 
these matters, we generally 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 concerns of 
the commenters, and a mechanism to address some of those concerns.
    Many commenters supported the overall expansion of telehealth by:
    <bullet> Removing geographic restrictions to include both rural and 
urban areas.
    <bullet> Revising permissible originating sites to include a 
patient's home, domiciliary care and first responder vehicles.

[[Page 67602]]

    <bullet> Adopting a broader definition of telehealth technologies 
to include services provide via mobile technology, including emails, 
phone calls, and store-and-forward technologies.
    <bullet> Adding physical and occupational therapists as 
practitioners who can remotely furnish telehealth services.
    <bullet> Adding more services to the telehealth list, including 
services under category 2.
    <bullet> Prioritizing coverage of services that include care 
coordination with the patient's medical home and/or existing treating 
physicians.
    <bullet> Considering the use of telehealth technology for the 
purpose of furnishing direct supervision of services furnished by on-
site practitioners.
    <bullet> Using demonstration projects under CMS's Center for 
Medicare and Medicaid Innovation (CMMI) to collect clinical evidence on 
the effect of expanding telehealth and to address how telemedicine can 
be integrated into new payment and delivery models.
    Response: We appreciate the commenters' suggestions. As some 
commenters noted, we do not have authority to implement many of these 
revisions under the current statute. The CMS Innovation Center is 
responsible for developing and testing new payment and service delivery 
models to lower costs and improve quality for Medicare, Medicaid, and 
CHIP beneficiaries. As part of that authority, the CMS Innovation 
Center can consider potential new payment and service delivery models 
to test changes to Medicare's telehealth payment policies.
    In summary, after consideration of the comments we received, we are 
finalizing our proposal to add psychotherapy services CPT codes 90845, 
90846 and 90847; prolonged service office CPT codes 99354 and 99355; 
and annual wellness 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 Sec.  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 
services through the PFS rulemaking process so that the public has the 
opportunity to comment on additions to the list. We are also finalizing 
our proposal to revise Sec.  410.78(f) to indicate that a list of 
Medicare telehealth codes and descriptors is available on the CMS Web 
site.
    We remind all interested stakeholders that we are currently 
soliciting public requests to add services to the list of Medicare 
telehealth services. To be considered during PFS rulemaking for CY 
2016, these requests must be submitted and received by December 31, 
2014. Each request to add a service to the list of Medicare telehealth 
services must include any supporting documentation the requester wishes 
us to consider as we review the request. For more information on 
submitting a request for an addition to the list of Medicare telehealth 
services, including where to mail these requests, we refer readers to 
the CMS Web site at www.cms.gov/telehealth/.
5. Telehealth Originating Site Facility Fee Payment Amount Update
    Section 1834(m)(2)(B) of the Act establishes the Medicare 
telehealth originating site facility fee for telehealth services 
furnished from October 1, 2001, through December 31 2002, at $20.00. 
For telehealth services furnished on or after 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 MEI 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 
lesser of the actual charge or $24.83. The Medicare telehealth 
originating site facility fee and MEI increase by the applicable time 
period is shown in Table 13.

 Table 13--The Medicare Telehealth Originating Site Facility Fee and MEI
                 Increase by the Applicable Time Period
------------------------------------------------------------------------
                                   MEI
         Facility fee           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  01/01/2015-12/31/2015
------------------------------------------------------------------------

F. Valuing New, Revised and Potentially Misvalued Codes

    Establishing valuations for newly created and revised CPT codes is 
a routine part of maintaining the PFS. Since inception 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 RUC have identified a number of potentially misvalued codes using 
various identification screens, such as codes with high growth rates, 
codes that are frequently billed 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 proposed and finalized 
consolidation of the five-year review and the potentially misvalued 
code activities into an annual review of potentially misvalued codes to 
avoid redundancies in these efforts and better accomplish our goal of 
assuring regular assessment of code values. Under the consolidated 
process, 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 the calendar year covered by the final rule. 
(Changes in the PFS methodology that may affect valuations 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 period for the subsequent year. When consolidating 
these processes, we indicated that it was

[[Page 67603]]

appropriate to establish interim values for new, revised, and 
potentially misvalued codes because of the incongruity between the PFS 
rulemaking cycle and the release of codes by the AMA CPT Editorial 
Panel and the RUC review process. We stated that if we did not 
establish interim final values for revalued codes in the final rule 
with comment period, ``a delay in implementing revised values for codes 
that have been identified as misvalued would perpetuate payment for the 
services at a rate that does not appropriately reflect the relative 
resources involved in furnishing 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 codes, we would either have to delay the use 
of new and revised codes for one year, or permit each Medicare 
contractor to establish its own payment rate for these codes. We 
stated, ``We believe 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 
from the medical community [through the RUC] before adopting the 
values, and the alternatives could produce undesirable levels of 
uncertainty and inconsistency in payment for a year.''
1. Current Process for Valuing New, Revised, 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 specific codes 
and/or groups of codes that we believe may be appropriate to consider 
under our potentially misvalued code initiative. As part of our process 
for developing the list of proposed potentially misvalued 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 include 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 comments and establish a final list of potentially misvalued codes 
in the final rule for that year. These potentially misvalued codes are 
reviewed and revalued, if appropriate, in subsequent years. In 
addition, the RUC regularly identifies potentially misvalued codes 
using screens that have previously been 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 
codes through its standard process, which includes active involvement 
of national specialty societies for the specialties that ordinarily 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 descriptors. The AMA has estimated that 75 percent of 
all annual CPT coding changes result from the potentially misvalued 
code initiative.
    The RUC provides CMS with recommendations for the work values and 
direct PE inputs for the codes we have identified as potentially 
misvalued codes or, in the case of a coding revision, for the new or 
revised codes that will replace these potentially misvalued codes. 
(This process is also applied to codes that the RUC 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 misvalued code(s). 
We believe 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 recommendations 
for the code or replacement code(s) within a year or two following the 
identification 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 any other codes for which there are coding changes in 
the final rule with comment period for a year. There is a 60-day period 
for the public to comment on those interim final values after we issue 
the final rule. For services furnished during the calendar year 
following the publication of interim final rates, we pay for services 
based upon the interim final values established in the final rule. In 
the final rule with comment period for the subsequent year, we consider 
and respond to public 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 rule 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 and across code families. In addition, 
this process assures that we have the benefit of the RUC 
recommendations for all codes being valued.
2. Concerns With Current Process
    Some stakeholders who have experienced reductions in payments 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 have stated that they did not receive notice of 
the possible reductions before they occurred. Generally, stakeholders 
are aware that we are considering changes in the payment rates for 
particular 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, representatives 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 regarding the time it takes to furnish 
the services, and representatives of the specialty(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.
    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 values because the RUC actions and recommendations are not 
public. Some stakeholders have also said that the individuals who 
participate in the RUC review process are not able to share the 
recommendations because they have signed a confidentiality agreement. 
We note, however, that at least one specialty society has raised funds 
via its Web site to fight a ``pending 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

[[Page 67604]]

under the PFS are not permitted to participate in the RUC process at 
all.
    We recognize that some stakeholders, including those practitioners 
represented by societies that are not participants in the RUC process, 
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 
process. As a result, all stakeholders should be aware that a 
particular code is being considered as potentially misvalued and that 
we may establish revised interim final values 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 and comment rulemaking as 
potentially misvalued codes. We recognize that if stakeholders are not 
monitoring RUC activities or evaluating Medicare claims data, they may 
be unaware that these codes are being reviewed and could be revalued on 
an interim final basis in a final rule with comment period for a year.
    In recent years, we have increased our scrutiny 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 find it appropriate, on an interim final basis, 
to refine how the CPT codes are to be used for Medicare services or to 
create 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 review 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 payment rates. In response 
to those commenters, we note that the process we use to establish 
interim final rates is in full accordance with the statute and we do 
not find this a persuasive reason to consider 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 
existing process. In the CY 2014 PFS final rule with comment period, we 
established interim final values 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 the 
facility setting, the reductions 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 the RUC 
process and were generally aware that the family of codes would be 
revalued on an interim 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, which explains, 
in large part, the reduction to values in the office setting. The 
societies representing the affected 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 furnish 
the services, which resulted in reductions in both the work and PE 
portion of the values. Although the specialties were aware of the 
changes that the RUC was recommending to direct PE inputs, they were 
not specifically aware of how those changes would affect the values and 
payment rate. In addition, we decreased the work RVUs for these 
procedures because we found the RUC-recommended work RVUs did not 
adequately reflect the RUC-recommended decreases in time. 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 suggesting an increase in 
work intensity. Since the interim final values for these codes were 
issued 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 process 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 epidural 
injection codes for CY 2015.)
3. Alternatives to the Current Process
    In the proposed rule, we noted that given our heightened review of 
the RUC recommendations and the increased concerns expressed by some 
stakeholders, we believed that an assessment of our process for valuing 
these codes was warranted. To that end, we considered potential 
alternatives to address the timing and rulemaking issues associated 
with establishing values for new, revised and potentially misvalued 
codes (as well as for codes within the same families as these codes). 
Specifically, we explored three alternatives to our current approach:
    <bullet> Propose work and MP RVUs and direct PE inputs for all new, 
revised and potentially misvalued codes in a proposed rule.
    <bullet> 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.
    <bullet> 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 misvalued codes to increase 
transparency, but without making changes 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, revised, 
and potentially misvalued codes in the proposed rule:
    Under this approach, we stated that we would 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 available PFS proposed rule. We would receive and 
consider public comments on those proposals and establish 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 calendar, all CPT coding changes and most RUC recommendations 
are not available to us in time to include proposed values for

[[Page 67605]]

all codes in the proposed rule for that year.
    Therefore, we stated that if we were to adopt this proposal, which 
would require us to propose changes in inputs before we revalue codes 
based upon those values, we would need a mechanism to pay for services 
for which the existing 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 contribution that 
the CPT Editorial Panel makes to the success of the potentially 
misvalued code initiative through its consideration and adoption of 
coding changes. Although we have increased our scrutiny of the RUC 
recommendations in recent years and accepted fewer of the 
recommendations without making our own refinements, the CPT codes and 
the RUC recommendations continue 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 work. 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 reliable and comparable across specialties and services than 
would be possible without having the RUC at the center of the survey 
vetting process. In addition, the debate and discussion of the services 
at the RUC meetings in which CMS staff participate provides a good 
understanding of what the service entails and how it compares to other 
services in the family, and to services furnished by other specialties. 
The debate among the specialties is also an important part of this 
process. Although we increasingly consider data and information from 
many other sources, and we intend 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 
take effect for the following year but for which we did not receive RUC 
recommendations in time to include proposed work values and PE inputs 
in the proposed rule. Because the annual coding changes are effective 
on January 1st of each year, we would need a mechanism for 
practitioners to report services and be paid appropriately during the 
interval between the date the code takes effect and the time that we 
receive RUC recommendations and complete rulemaking to establish values 
for the new and revised codes. One option would be to establish G-codes 
with identical descriptors to the predecessors of the new and revised 
codes and, to the fullest extent possible, carry over the existing 
values for those codes. This would effectively preserve the status quo 
for one year.
    The primary advantage of this approach would 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 opportunity to 
comment on a specific proposal prior to it being implemented. This 
would be a far more transparent process, and would assure that we have 
the 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 for CMS 
and for practitioners. Presumably, practitioners would need to use the 
G-codes to report certain services for purposes of Medicare, but would 
use the new or revised CPT codes to report the same services to private 
insurers. The number of G-codes needed each year would depend on the 
number of CPT code changes for which we do not receive the RUC 
recommendations 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 
need to use G-codes for this purpose.
    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 select 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 
neutral 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 public 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 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:
    This alternative approach would allow for notice and comment 
rulemaking before we adopt values for some new, revised and potentially 
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 basis (those for which we do not receive the 
RUC recommendations in time). Under this approach, we would establish 
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 pending receipt of the RUC recommendations 
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 year, there would be no change from the existing 
valuation process.
    This would be a balanced approach that recognizes the benefits of a 
full opportunity for notice and comment rulemaking before establishing 
rates when timing allows, and the 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 without the benefit of full 
public notice and comment. Another concern with this approach is that 
it could lead to the valuation of codes within the same family at 
different times depending on when we receive RUC recommendations for 
each code within a family. As discussed previously, we believe it is 
important to value an entire code family together to make adjustments 
to account appropriately for relativity within the family and between 
the family and other families. If we receive RUC recommendations in 
time to propose

[[Page 67606]]

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 differences 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 recommendation for the code. 
Although this approach would offer stakeholders the opportunity to 
comment on specific proposals in the proposed rule, the adoption of 
changes for a separate group of codes in the final rule could 
significantly change the proposed values simply due to the budget 
neutrality 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 misvalued codes in order to increase 
transparency, but without a change to the existing process for 
establishing values:
    The main concern with continuing our current approach is that 
stakeholders have expressed the desire to have adequate and timely 
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 address some aspects of this 
issue by increasing the transparency of the current process. 
Specifically, we could make more information available on the CMS Web 
site before interim final values are established for codes. Examples of 
such information include an up-to-date list of all codes that have been 
identified as potentially misvalued, a list of all codes for which RUC 
recommendations 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 notice 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, stakeholders would not have an opportunity to 
provide input on our potential modifications before interim final 
values are adopted.
4. Proposal To Modify the Process for Establishing Values for New, 
Revised, and Potentially Misvalued Codes
    After considering the current process, including its strengths and 
weaknesses, and the alternatives to the current process described 
previously, we proposed to modify our process to make all changes in 
the work and MP RVUs and the direct PE inputs for new, revised and 
potentially misvalued services under the PFS by proposing the changes 
in the proposed rule, 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 15th of the preceding year. We also proposed 
to delay revaluing the code for one year (or until we receive RUC 
recommendations for the code before January 15th of a year) and include 
proposed values in the following year's rule if the RUC recommendation 
was not received in time for inclusion in the proposed rule. Thus, we 
would include proposed values prior to using the new code (in the case 
of new or revised codes) or revising the value (in the case of 
potentially misvalued codes). Due to the complexities involved in code 
changes and rate setting, there could be some circumstances where, even 
when we receive the RUC recommendations by January 15th 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 additional information to appropriately value 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 15th.
    For new, revised, and potentially misvalued codes for which we do 
not receive RUC recommendations before January 15th of a year, we 
proposed to adopt coding policies and payment rates that conform, to 
the extent possible, to the policies and rates in place for the 
previous year. We would adopt these conforming 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. For codes for which there is no change in the CPT code, it is a 
simple matter to continue the current valuation. For 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 rulemaking process. Since the changes in CPT codes are 
effective on January 1st of a year, and we would not have established 
values for the new or revised codes (or other codes within the code 
family), it would not be practical for Medicare to use those CPT codes. 
For codes that were revised or deleted 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 relevant RUC recommendations 
prior to the proposed rule, we propose to create G-codes to describe 
the predecessor codes to these codes. If CPT codes are revised in a 
manner that would not affect the resource inputs used to value the 
service (for example, a grammatical changes to CPT code descriptors), 
we could use these revised codes and continue to pay at the rate 
developed 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 two codes before January 15th of the year, 
we would assign each of those new codes an ``I'' status indicator 
(which denotes that the codes are ``not valid for Medicare purposes''), 
and those codes could not be used for Medicare payment during the year. 
Instead, we would create a G-code with the same description as the 
single predecessor CPT code and continue to use the same inputs as the 
predecessor CPT code for that G-code during the year.
    For new codes that describe wholly new services, as opposed to new 
or revised codes that are created as part of a coding revision of a 
family or that describe services are already on the PFS, we would make 
every effort to work with the RUC to ensure that we receive 
recommendations in time to include proposed values in the proposed 
rule. However, if we do not receive timely recommendations from the RUC 
for 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 initial year. As we do under our 
current policy, if we receive the RUC recommendations in time to 
consider them for the final rule, we propose to establish values for 
the initial year on an interim final basis subject to comment in the 
final rule. In the event we do not receive RUC recommendations in time 
to consider them for the final rule, or in other situations where it 
would not be appropriate to establish interim final

[[Page 67607]]

values (for example, because of a lack of necessary information about 
the work or the price of the PE inputs involved), we would contractor 
price the code for the initial year.
    We specifically sought comments on the following topics:
    <bullet> Is this proposal preferable to the present process? Is 
another one of the alternatives better?
    <bullet> If we were to implement this proposal, is it better to 
move forward with the changes, or is more time needed to make the 
transition such that implementation should be delayed beyond CY 2016? 
What factors should we consider in selecting an implementation date?
    <bullet> 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 commenters 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 process include most medical organizations. MedPAC 
supported including proposals for rate changes in the proposed rule, 
but disagreed with preserving existing rates when RUC recommendations 
were not received in time to value 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 process. MedPAC also encouraged 
us to work with the CPT Editorial Panel and the RUC to better 
disseminate information about coding and payment recommendations that 
might be used for interim values as far in advance as possible. Several 
commenters who do not currently participate in the development of RUC 
recommendations suggested that we require the RUC to make its 
operations more transparent. Most of the commenters that supported the 
proposal also suggested making at least some modifications to the 
proposal. 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 goes 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 process by including 
proposed changes 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 presented, and only one comment 
suggesting that the current process was ideal and should be maintained. 
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 the 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 these efforts and also to 
consider ways that all physicians, practitioners and other suppliers 
paid under the PFS are aware 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 
and 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 
considered in relation to all codes being revalued in a year in order 
to allow public comment on the entire fee schedule at one time. 
Additionally, we believe it is difficult 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 medical specialties 
opposed the proposed CY 2016 implementation and asked that it be 
delayed 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 changed. These commenters also suggested that by delaying until 
CY 2017, the CPT Editorial 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, including 
those with major code revisions for CY 2015, such as codes for 
radiation therapy and upper gastrointestinal 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 positions 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 commenters 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 approach 
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 most appropriate 
time frame for implementation, we believe that flexibility in 
implementation offers the optimal solution. Accordingly, we are 
delaying 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 codes 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 process 
so that those who have requested new codes and modifications in 
existing codes with the expectation 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 
that would allow a much higher percentage of codes to be addressed in 
the proposed rule, and has shared with us some plans to achieve this 
goal. We appreciate AMA's efforts and are confident that with the 
finalization of this process, the CPT Editorial Panel and the RUC will 
be able to adjust their timelines and processes so that most, if

[[Page 67608]]

not all, of the annual coding changes and valuation recommendations can 
be addressed in the proposed rule prior to the effective date 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 new, revised, and potentially misvalued codes for which we do 
not receive RUC recommendations in time for inclusion in the proposed 
rule, we anticipate establishing interim final values for them for CY 
2016, consistent with the current process. Beginning with valuations 
for CY 2017, the new process will be applicable to all codes. In other 
words, beginning with rulemaking for CY 2017, we will propose values 
for the vast majority of new, revised, and potentially misvalued codes 
and consider public comments before establishing final values for the 
codes; 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 services for which there are no 
predecessor codes or values and for which we do not receive RUC 
recommendations in time to propose values. Consistent with this policy, 
we are finalizing our proposed regulatory change to Sec.  414.24 with 
the addition of the phrase ``For valuations for calendar year 2017 and 
beyond,'' to paragraph (b) to reflect the implementation for all CY 
2017 valuations.''
    Comment: Commenters also addressed the January 15th 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 commenters suggesting a variety of dates 
between January 31st and April. Commenters suggested 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 inclusion 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 requires 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, we 
believe we will need more time to complete the process of formulating 
proposals. We believe that we need to establish a consistent deadline 
for receipt of RUC recommendations in order to allow all stakeholders 
and CMS to plan appropriately. To balance competing priorities, we are 
finalizing a deadline of February 10th. Our ability to complete our 
work in this more limited time will depend in large part on the volume 
of recommendations 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 receive after the beginning of 
the year.
    Comment: The majority of commenters opposed the use of G-codes, 
primarily citing the administrative burden of having to use a separate 
set of codes for Medicare claims. One commenter called the G-code 
proposal ``unworkable.'' In addition, MedPAC objected to the principal 
of attempting to maintain rates that are known to be misvalued. Those 
supporting the use of G-codes generally recognized the administrative 
burden, but believed the importance of the opportunity for public 
comment on proposed values before they take effect outweighed the 
administrative inconvenience. Commenters urged us to minimize the use 
of G-codes.
    Response: We recognize the commenters' concerns with the use of G-
codes. We agree that it is preferable to use CPT codes whenever 
possible. 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 RUC recommendations for 
all new, revised and potentially misvalued codes before February 10th 
of the prior year. However, we need to preserve our ability to 
establish a proxy for current coding and values in situations where we 
receive the RUC recommendations too late or, for some other reason, 
encounter serious difficulty developing proposed values for revised 
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 believe the program and its stakeholders are better served by 
delaying revaluations for one year while we used the notice and comment 
process to obtain public comments in advance. The comments on this 
proposal were overall 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 the difficulties created by the use of G-codes and will 
seek to minimize their use. We also note that 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 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 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 and 
redistributive effects that could occur if we accepted extensive 
increases in work RVUs across a broad range of services.
    Following enactment of section 1848(c)(2)(K) of the Act, which 
required the Secretary periodically to review potentially misvalued 
codes and make appropriate adjustments to the RVUs, we reassessed the 
refinement panel process. As detailed in the CY 2011 PFS final rule 
with comment period (75 FR 73306), we continued using the established 
refinement panel process with some modifications.
    As we considered making changes to the process for valuing codes, 
we reassessed the role that the refinement panel process plays in the 
code valuation process. We noted that the current refinement panel 
process is tied to interim final values. It provides an opportunity for 
stakeholders to provide

[[Page 67609]]

new clinical information that was not available at the time of the RUC 
valuation that might affect work RVU values that are adopted in the 
interim final value process. We noted that if our proposal to modify 
the valuation 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 values could be addressed through the notice and 
comment process. Similarly, prior to CY 2012 when 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 
procedure before values are used for purposes of payment, offers 
stakeholders a better mechanism for providing any additional data for 
our consideration and discussing any concerns with our proposed values 
than the current refinement process
    Comment: We received many comments on our proposal to eliminate the 
refinement panel, but most addressed problems with the existing 
refinement process and suggested improvements and alternatives rather 
than reasons not to eliminate the refinement panel. Concerns with the 
refinement panel process included that CMS imposed too high a standard 
for referring codes to refinement and that CMS decreasingly changed 
values based upon the refinement panel results. Some noted that 
organizations with limited resources are disadvantaged compared to 
those with significant 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 understanding that the refinement panel 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 contractor 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 organized appeal process will likely lead to a fragmented 
lobbying effort, rather than an objective review process.''
    MedPAC suggested that we use a panel with membership limited to 
those without a financial stake in the process, such as contractor 
medical directors, experts in medical economics and technology 
diffusion, private payer representatives, and a mix of physicians 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' concerns and believe that 
some of the dissatisfaction with the current refinement panel mechanism 
stems from the expectation that it constitutes an appeals process. We 
do not agree. We believe the purpose of the refinement panel is to give 
us additional information to consider in exercising our responsibility 
to establish appropriate RVUs for Medicare services. Like many of the 
commenters, we believe the refinement panel is not achieving its 
purpose. Rather than providing us with additional information to assist 
us in establishing work RVUs, most often the refinement panel 
discussion reiterates the issues raised and information discussed at 
the RUC. Since we had access to this information at the time interim 
final values were 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 considered. 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 finalizing 
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 also explore ways to address the many 
concerns that we and stakeholders have about the refinement panel 
process and whether the change in process eliminates the need for a 
refinement panel.
    We are also finalizing our proposed change to the regulation at 
Sec.  414.24 with the addition of the phrase ``For valuations for 
calendar year 2017 and beyond,'' to paragraph (b) to reflect 
implementation of the revised process for all valuations beginning with 
those for CY 2017.

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 
postservice activities, as well as other components of the service that 
contribute to the value. Our review generally includes, 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 Medicare 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 through 73329), we 
discussed a variety of methodologies and approaches used to develop 
work RVUs, including survey data, building blocks, crosswalk to key 
reference or similar 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 conducted by specialty 
societies as part of the formal RUC process. The building block 
methodology is used to construct, 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 
postservice time and post-procedure visits. When referring to a bundled 
CPT code, the components could be the CPT

[[Page 67610]]

codes that make up the bundled code. Magnitude estimation refers to a 
methodology for valuing physician work that determines the appropriate 
work RVU for a service by gauging the total amount of physician work 
for that service relative to the physician work for similar service 
across the PFS without explicitly valuing the components 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 
service, all relative to other services.
    Several years ago, to aid in the development of preservice time 
recommendations 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 different combinations of straightforward or difficult procedure, 
straightforward or difficult patient, and without or with sedation/
anesthesia. Currently, there are three preservice time packages for 
services typically furnished in the nonfacility setting, reflecting 
procedures without and with 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 
evaluation and management (E/M) service, we believe that there is 
overlap between the two services in some of the activities furnished 
during the preservice evaluation and postservice time. We believe that 
at least one-third of the physician time in both the preservice 
evaluation and postservice period is duplicative of work furnished 
during the E/M visit. Accordingly, in cases where we believe that the 
RUC has not adequately accounted for the overlapping activities in the 
recommended 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 the product 
of the time involved in furnishing the service times the intensity of 
the work. Preservice evaluation time and postservice time both have a 
long-established intensity 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 x 0.0224 IWPUT) 
if we do not believe the 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 codes are available 
in Addendum B. The RVUs and other payment information for all codes 
subject to public comment are available in Addendum C. Both addenda are 
available on the CMS Web site 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 Web site 
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 public 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 PFS Addenda,'' available on 
the CMS Web site under downloads for the CY 2015 PFS final rule with 
comment period at http://www.cms.gov/physicianfeesched/PFS-Federal-Regulation-Notices.html/. The direct PE inputs are listed in a file 
called ``CY 2015 PFS Direct PE Inputs,'' available on the CMS Web site 
under downloads for the CY 2015 PFS final 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 final 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 discuss the 
work involved in each procedure under review, and then each panel 
member would individually rate the work of the procedure. We believed a 
multispecialty group would balance the interests of the specialty 
societies who commented on the work RVUs with the budgetary and 
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 four 
groups: Clinicians representing the specialty identified with the 
procedures in question; physicians 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 
refinement panel process. As detailed in the CY 2011 PFS final rule 
with comment period (75 FR 73306), we believed that the refinement 
panel process might provide an opportunity to review and discuss the 
proposed and interim final work RVUs with a clinically diverse group of 
experts, 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 would continue using the 
established panel composition that includes representatives from the 
four groups--clinicians representing the specialty identified with the 
procedures in question, physicians with practices in related 
specialties, primary 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, 
following discussion of the information but without an attempt to reach 
a consensus, each member of the panel submits an independent rating to 
CMS. Historically, the refinement panel's recommendation to change a 
work value or to retain the interim final value had

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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 panel members became less reliable as the physicians in each 
group tended to select a previously discussed value, rather than 
developing a unique value, thereby reducing the observed variability 
needed to conduct a robust statistical test. In addition, reliance on 
values developed using the F-test also occasionally resulted in rank 
order anomalies among services (that is, a more complex procedure is 
assigned lower RVUs than a less complex procedure). As a result, we 
eliminated the use of the statistical F-test and replaced it with the 
median work value of the individual panel members' ratings. We stated 
that this approach would simplify the refinement process 
administratively, while providing a result that reflects the summary 
opinion of the panel members based on a commonly 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 RVUs 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 where there is new clinical information available that might 
provide a reason for a change in work 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 seeking 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 concerning the work required to furnish a service 
so that we can consider whether the new information warrants referral 
to the refinement panel (57 FR 55917).
    We note that most of the information presented during the last 
several refinement panel discussions has been duplicative of the 
information provided to the RUC during its development of 
recommendations and considered by CMS in establishing values. As 
detailed above, we consider information and recommendations from the 
RUC when assigning proposed and interim final RVUs to services. Thus, 
if the only information that a commenter has to present is information 
already considered by the RUC, referral to a refinement panel is not 
appropriate. We request that commenters seeking 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 physician 
volunteers involved, by avoiding duplicative consideration of 
information by the RUC, CMS, and a refinement panel. To achieve this 
goal, CMS will continue to critically evaluate the need to refer codes 
to refinement panels in future years, specifically considering any new 
information provided by commenters.
(2) CY 2014 Interim Final Work RVUs Considered by the Refinement Panel
    We referred to the CY 2014 refinement panel 19 CPT codes with CY 
2014 interim final work values for which we received a request for 
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-specialty panel of physicians to assist us in the review of the 
information submitted to support increased work RVUs. The panel was 
moderated by our physician advisors, and consisted of the following 
voting members:
    <bullet> One to two clinicians representing the commenting 
organization.
    <bullet> One to two primary care clinicians nominated by the 
American Academy of Family Physicians and the American College of 
Physicians.
    <bullet> Four Contractor Medical Directors (CMDs).
    <bullet> One to two clinicians with practices in related 
specialties, who were expected to have knowledge of the services under 
review.
    The panel process was designed to capture each participant's 
independent judgment and his or her clinical experience which informed 
and drove the discussion of the refinement code during the refinement 
panel proceedings. Following the discussion, each voting participant 
rated the work of the refinement code(s) and submitted those ratings to 
CMS directly and confidentially. We note that not all voting 
participants voted for every CPT code. There was no attempt to achieve 
consensus among the panel members. As finalized in the CY 2011 PFS 
final rule with comment period (75 FR 73307), we calculated the median 
value for each service based upon the individual ratings that were 
submitted to CMS by panel participants.
    Table 14 presents information on the work RVUs for the refinement 
codes, including the refinement panel ratings and the final CY 2015 
work RVUs. In section II.G.2.a.ii., we discuss the CY 2015 work RVUs 
assigned each of the individual refinement codes.

                      Table 14--Codes Reviewed by the 2014 Multi-Specialty Refinement Panel
----------------------------------------------------------------------------------------------------------------
                                                      CY 2014           RUC         Refinement
   HCPCS Code               Descriptor             interim final    recommended    panel median    CY 2015 work
                                                     work RVU        work RVU         rating            RVU
----------------------------------------------------------------------------------------------------------------
19081..........  Biopsy of breast accessed                  3.29            3.29            3.40            3.29
                  through the skin with
                  stereotactic guidance.
19082..........  Biopsy of breast accessed                  1.65            1.65            1.78            1.65
                  through the skin with
                  stereotactic guidance.
19083..........  Biopsy of breast accessed                  3.10            3.10            3.10            3.10
                  through the skin with
                  ultrasound guidance.
19084..........  Biopsy of breast accessed                  1.55            1.55            1.55            1.55
                  through the skin with
                  ultrasound guidance.
19085..........  Biopsy of breast accessed                  3.64            3.64            3.64            3.64
                  through the skin with MRI
                  guidance.
19086..........  Biopsy of breast accessed                  1.82            1.82            1.82            1.82
                  through the skin with MRI
                  guidance.

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19281..........  Placement of breast                        2.00            2.00            2.00            2.00
                  localization devices accessed
                  through the skin with
                  mammographic guidance.
19282..........  Placement of breast                        1.00            1.00            1.00            1.00
                  localization devices accessed
                  through the skin with
                  mammographic guidance.
19283..........  Placement of breast                        2.00            2.00            2.00            2.00
                  localization devices accessed
                  through the skin with
                  stereotactic guidance.
19284..........  Placement of breast                        1.00            1.00            1.00            1.00
                  localization devices accessed
                  through the skin with
                  stereotactic guidance.
19285..........  Placement of breast                        1.70            1.70            1.70            1.70
                  localization devices accessed
                  through the skin with
                  ultrasound guidance.
19286..........  Placement of breast                        0.85            0.85            0.85            0.85
                  localization devices accessed
                  through the skin with
                  ultrasound guidance.
19287..........  Placement of breast                        2.55            3.02            3.02            2.55
                  localization devices accessed
                  through the skin with MRI
                  guidance.
19288..........  Placement of breast                        1.28            1.51            1.51            1.28
                  localization devices accessed
                  through the skin with MRI
                  guidance.
43204..........  Injection of dilated esophageal            2.40            2.89            2.77            2.40
                  veins using an endoscope.
43205..........  Tying of esophageal veins using            2.51            3.00            2.88            2.51
                  an endoscope.
43213..........  Dilation of esophagus using an             4.73            5.00            5.00            4.73
                  endoscope.
43233..........  Balloon dilation of esophagus,             4.05            4.45            4.26            4.26
                  stomach, and/or upper small
                  bowel using an endoscope.
43255..........  Control of bleeding of                     3.66            4.20            4.20            3.66
                  esophagus, stomach, and/or
                  upper small bowel using an
                  endoscope.
----------------------------------------------------------------------------------------------------------------

(ii) Code-Specific Issues
    For each code with an interim final work value, Table 15 lists the 
CY 2014 interim final work RVU and the CY 2015 work RVU and indicates 
whether we are finalizing the CY 2015 work RVU. For codes without a 
work RVU, the table includes a PFS procedure status indicator. A list 
of the PFS procedure status indicators can be found in Addendum A. If 
the CY 2015 Action column indicates that the CY 2015 values are interim 
final, we will accept public comments on these values during the public 
comment period for this final rule with comment period. A comprehensive 
list of all values for 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 
available on the CMS Web site under downloads at http://www.cms.gov/physicianfeesched/PFSFederalRegulationNotices.html/. The time values 
for all codes are listed in a file called ``CY 2015 PFS Work Time,'' 
available on the CMS Web site under downloads for the CY 2015 PFS final 
rule with comment period at http://www.cms.gov/physicianfeesched/downloads/.
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BILLING CODE 4120-01-C

    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 are 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 with 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 supportive 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.
(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, 
which 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 marker placement codes, and refined 
it to a lower value. Since we had adopted the RUC recommendation 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 also. We also changed the 
intraservice time of CPT code 19286, an add-on code, from 19 minutes to 
15 minutes since we believed the intraservice time of an add-on code 
should not be higher than its base code and the base code for CPT code 
19286, has an intraservice time of 15 minutes.
    Comment: Several commenters disagreed with the new CPT coding 
structure for breast biopsy and placement of breast localization 
devices because, unlike the predecessor structure, it fails to 
distinguish between the two types of biopsy 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 that distinguish 
between standard core needle biopsy and vacuum assisted biopsy.
    Response: We prefer to use the CPT coding structure unless a 
programmatic need suggests that an alternative coding structure is 
preferable. In this case, we believe that we can 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, stating that the 
higher RUC-recommended RVUs were more appropriate and would maintain 
relativity within the family. The commenters stated that these services 
have longer intraservice time than other codes in the marker placement 
family, are of high intensity, produce high patient and family anxiety, 
and have higher malpractice costs. One commenter requested that the 
entire breast biopsy code family be referred to refinement. Other 
commenters requested refinement panel review of selected codes within 
this family.
    Response: Based upon this request, we referred this family of codes 
to the CY 2014 multi-specialty refinement panel for further review. 
Prior to CY

[[Page 67632]]

2014, breast biopsies and marker placements were billed using a single 
code. 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. Combining the 
values for the marker placement or biopsy codes with the guidance codes 
should not, in our view, result in a change in the rank order of the 
guidance. Accordingly, we do not believe the bundled code that includes 
MR guidance should now be valued significantly higher than one that 
includes the stereotactic guidance. Also, the refinement panel 
discussions did not provide new clinical information. Therefore, we 
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 other base code/
add-on relationships across the family.
    Response: We agree and are finalizing the 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 breast marker 
placement procedure, commenters agreed that it was. However, they 
disagreed with our assertion that if it was typical it should be 
bundled with the appropriate breast marker procedures. Commenters 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 feedback. We are not 
bundling post procedure mammograms with the appropriate breast marker 
codes 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 final rule 
with comment period, we established 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 specialty 
societies and the RUC raised concerns regarding the appropriate 
valuation of these services, especially related to the use of the best 
data source for determining the intraservice time involved in 
furnishing PFS services. Specifically, there was significant variation 
between the time values estimated through a survey versus those 
collected through specialty databases. We characterized our concerns 
saying, ``The divergent recommendations from the specialty societies 
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 and outpatient visits included 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 RUC-recommended work RVUs for these two codes to 
reflect the visits in the global period as recommended by the specialty 
societies, resulting in a 1.12 work RVU increase from the RUC-
recommended value for each code. Accordingly, 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 also the most appropriate reconciliation for the 
conflicting information regarding time values for these services as 
presented to us by the physician community. We also sought public 
comment 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 furnished during the global 
periods for the services described by these codes.
    Comment: The RUC submitted comments explaining how it reached its 
recommendations for these codes and that it followed its process 
consistently in developing its recommendations on these codes. All 
those who commented specifically on the interim final work RVUs for 
these codes objected to the interim 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, which 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 commenters' suggestions 
were using data from the Function and Outcomes Research for Comparative 
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 explore the 
best data collection methods. 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 methodology 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 commenters expressed concern 
regarding the use of a final rule to establish interim values for 
established hip and knee procedures due to the lack of opportunity it 
provides stakeholders to analyze 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 these services and 
requested additional input from stakeholders regarding using other 
sources 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 need to be able to use routinely in valuing 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 
alternative data sources to use in determining the times associated 
with particular services. 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 
final work values established in CY 2014. The interim final values are 
based upon the best data we have available and preserve appropriate 
relativity with other codes.

[[Page 67633]]

Accordingly, we are finalizing the interim final values for these 
procedures.
(4) Transcatheter Placement Intravascular Stent (CPT Code 37236, 37237, 
37238, and 37239)
    For CY 2014, we established the RUC-recommended work RVUs for newly 
created CPT codes 37236, 37237, and 37238 as the interim final values. 
We disagreed with the RUC-recommended 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 the work for 
placement of an additional stent in a vein should bear the same 
relationship to the work of placing an initial stent 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 that our valuation of CPT code 
37239 was inappropriate. They indicated that instead we should use the 
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 stents are placed in an 
artery or a vein, and accordingly the appropriate ratio is found in the 
RUC-recommended work RVUs of CPT codes 37236 and 37237, the comparable 
codes for the arteries. For that reason, we are finalizing our CY 2014 
interim final values. Additionally, we did not refer these codes for 
refinement panel review because the criteria for refinement panel 
review were not met.
(5) Embolization and Occlusion Procedures (CPT Codes 37242 and 37243)
    For CY 2014, we established interim final work RVUs for these two 
codes based upon the survey's 25th percentile. As we discussed in the 
CY 2014 interim final rule with comment period, we believed that the 
RUC-recommended work RVU for CPT code 37242 did not adequately take 
into account the substantial 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 
since its last valuation and more appropriately reflected the work of 
the procedure. Similarly, we did not believe that the RUC-recommended 
work RVU for CPT code 37243 adequately considered the substantial 
decrease in intraservice time for the procedure; and we also use the 
survey's 25th percentile for CPT code 37243.
    Comment: Many commenters disagreed with 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 
inappropriate and recommended instead a work RVU of 14.00. Commenters 
requested that the family of codes be referred for refinement.
    Response: After consideration of the comments, we continue to 
believe that work RVUs should reflect the decreases in intraservice 
time that have occurred since the last valuation. As a result, we 
continue to believe that our CY 2014 interim final values are most 
appropriate and are finalizing them for CY 2015. Additionally, we did 
not refer these codes for refinement panel review because the criteria 
for refinement panel review were not met.
(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 reflected 
for about half of the rigid transoral esophagoscopy codes. 
Additionally, we noted that 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, with or without 
collection of specimen(s) by brushing or washing (separate procedure)) 
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 for 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 dissatisfaction 
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 valuation 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 code 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 asked that all these codes be referred to a 
refinement panel for reconsideration.
    Response: After consideration of the comments, we agree that 
modification of the CY 2014 interim final values is appropriate. Based 
upon the information provided in comments and further investigation, we 
believe that 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 work RVU is based on increasing the work RVU 
of the previous comparable code (1.59) to reflect the percentage 
increase in time for the CY 2014 code. For the remaining rigid 
esophagoscopy codes, we developed RVUs by starting with the RVUs for 
the corresponding flexible esophagoscopy 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 
establishing 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 Esophagoscopy (CPT Codes 43197 and 43198)
    We established CY 2014 interim final work RVUs of 1.48 for CPT code 
43197 and 1.78 for CPT code 43198. As detailed in the CY 2014 final 
rule with comment period, we removed 2 minutes

[[Page 67634]]

of the pre-scrub, dress and wait preservice 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 transnasal services are not typically furnished 
with moderate sedation.
    Comment: Multiple commenters objected to the work RVUs for these 
codes and in particular to CMS basing its valuation on the fact 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 involving local/topical anesthesia 
often take more work than those involving general sedation due to the 
difficulties of furnishing services to a conscious and often anxious 
patient. Some also noted 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 recommendations. 
Commenters requested that these codes be referred for refinement.
    Response: After consideration of the comments, we agree that the 
work RVUs for these codes should not be reduced because moderate 
sedation 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; diagnostic, including 
collection of specimen(s) by brushing or washing when performed) 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, respectively. We did 
not refer these codes to refinement because the request did not meet 
the 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 Table 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 methodologies used by CMS And the RUC include basing 
values on the surveys (either medians or 25th percentiles), 
crosswalking values to other codes, using the building block 
methodology, and valuing a family of codes based on the incremental 
differences in the work RVUs between the codes being 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 particular codes in direct proportion to the reduction in 
times that were recommended by the RUC. Using these methodologies, we 
assigned the RUC-recommended 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 obtained different values.
    Comment: Commenters objected to the interim final RVUs we assigned 
for CPT code 43200, the base code for flexible transoral esophagoscopy, 
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 esophagoscopy services. Commenters also 
disagreed with the way we used standard methodologies to value many of 
these codes, including 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 codes (CPT codes 
43204, 43205 and 43233) met the refinement criteria, and those were 
referred to the 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 another 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 to 
account for the 3 minute decrease in postservice time since the last 
valuation from the CY 2013 work RVU for the predecessor base code, 
which 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 that 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 the 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. 
Because we do not agree with commenters' contention that higher work 
RVUs are warranted since these codes involve the sicker patients or 
that our methodology for calculating the interim final RVUs was 
inappropriate, we are establishing final values determined using these 
methodologies. However, due to the change in the base code, CPT code 
43200, as discussed in the previous paragraph 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 comparable 
esophagogastroduodenoscopy (EGD) code and subtracting the difference in 
work between the base esophagoscopy and base EGD codes. After 
consideration of the comments that indicated the interim final work RVU 
of 4.21 was too low, we believe this code should instead be crosswalked 
to CPT code 31636 (Bronchoscopy bronch stents), which we believe is a 
comparable service with comparable intensity. It has the same 
intraservice time and slightly higher total time. 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 increasing 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 code 
43220, increased proportionately to reflect the longer intraservice 
time of CPT code 43213. The refinement panel median was 5.00 for this 
code. No new information was presented at the refinement panel. We 
continue to believe that 4.73 is the appropriate work RVU and are 
finalizing it.

[[Page 67635]]

    Based upon the information presented by commenters 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 results in a final work RVU of 3.50 as compared to 
an interim final of 3.38. This refinement also supports the belief made 
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 inappropriate since the 
intraservice time had not really changed. They contend that the change 
was from moving the time for moderate sedation from intraservice to 
preservice. We disagree. We have no information from the RUC that leads 
us to believe that when the pre-service packages were developed several 
years ago and moderate sedation was explicitly recognized as a pre-
service item that the RUC also intended CMS to assume that the 
intraservice times were no longer correct. We believe that our proposed 
valuation methodology is correct and thus are finalizing a work RUV of 
2.99.
    Commenters, disagreeing with our crosswalk 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 times and 
intensities are quite similar. We note that the RUC also bases 
crosswalks on the comparability of time and 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, 
stating 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 ultrasound 
portion of the examination of esophagus. Therefore, we are finalizing 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 appropriately 
reflected in the RUC recommendation. They objected to our basing the 
work RVU for 43232 on the difference between the RUC-recommended values 
for this code and CPT code 43231. We learned from the comments that the 
typical patient for this service has advanced cancer and agree that our 
interim final value may not represent the full extent of the work 
involved in this procedure. Therefore, we are crosswalking this code to 
CPT code 36595 (Mechanical removal of pericatheter obstructive material 
(eg, fibrin sheath) from central venous device via separate venous 
access), which has identical intraservice time, slightly less total 
time, and a slightly higher intensity and are finalizing a work RVU of 
3.59.
(10) Esophagogastroduodenoscopy (EGD) (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 
recommendations for changes in our interim final values. As we detailed 
in the CY 2014 final rule with comment period, we valued 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 work 
RVU of 4.05. We valued the additional 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 corresponding 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 code 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 crosswalked CPT 
codes 43239 to 43236, 43246 to 43255, 43253 to 43242 and 43257 to 
43238. We valued CPT codes 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 objected to our work RVUs and 
said that our reductions from the RUC recommendations were based on a 
decrease in intraservice time that did not reflect a change in the time 
required to furnish the procedures but rather only a change in which 
part of the procedure the RUC includes the moderate sedation time. 
Commenters disagree with our valuing CPT code 43233 based on the value 
of CPT code 43214, saying that CPT code 43233 is more intense due to 
the risk of perforation, and that the achalasia patients are at high 
risk and poor candidates for surgery. Commenters disagreed with our 
methodology for valuing CPT code 43235, and suggested that we use the 
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, commenters 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, commenters suggest that the 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 appropriate 
due to the additional work in CPT code 43239. Commenters disagreed with 
our value for CPT code 43242 stating that we inappropriately valued CPT 
code 43259, which we used in calculating the work RVUs for CPT code 
43242. Commenters objected to our value of CPT code 43246 because they 
disagree with the work RVU for the code that it is crosswalked to, CPT 
code 43255. Commenters urged us to modify

[[Page 67636]]

our work RVU for CPT code 43247 to equal the RUC recommendation. For 
CPT code 43253, commenters did not disagree with the valuation 
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 the 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. 
They also cited that this was an emergency procedure in unstable 
patients and that it was more 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 was 
more intense than CPT code 43238. Commenters acknowledged that reduced 
times should result in reduced work, but disagreed with our 
proportional reduction approach. Commenters agreed with our approach to 
valuing CPT code 43266, but disagreed with the valuation of the CPT 
code 43212, that we used as the base. With regard to CPT code 43270, 
commenters disagreed with using CPT code 43229 as the base.
    Response: For each of these codes, commenters were concerned that 
we did not accept the RUC-recommended values. Their common reasoning 
for urging us to accept the RUC-recommended 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 
described above for valuing EGD codes and did not base our values on 
the time change. Thus, any refinements to the RUC recommendations for 
the EGD codes are solely due to refinements in the ESO codes. We 
discussed our valuations of these codes in the previous section. Since 
we have finalized most of the ESO codes at higher levels than the CY 
2014 interim final values, we are making 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 finalizing 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 comments 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 Cholangiopancreatography (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 work 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 determining 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 25th percentile.
    Comment: Commenters objected to our valuation of CPT 43263 based 
upon a crosswalk to CPT code 43262, saying that CPT 43263 is more 
intense and has greater risks than CPT code 43262. Commenters also 
indicated that we underestimated the intensity of CPT code 43276 
indicating that CPT code 43276 typically involves replacing stents that 
are overgrown with cancerous tissues. They also said 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 comment 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 CPT code 43276 
based upon the formula described in the CY 2014 final rule with comment 
period adjusted for changes in the final work RVUs for values used in 
the formula. For CPT code 43277, we continue to believe the survey 25th 
percentile is appropriate. This valuation 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 formula 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)
    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 RVUs 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 through the high expenditure procedure 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 bilateral with decompression of spinal 
cord, cauda equina and/or nerve root[s], [eg, 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, based upon the 
RUC recommendations. We noted that we expected to review these values 
in concert with the RUC

[[Page 67637]]

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 resurveying this set of codes as a family since CPT codes 
63045 and 63046 constitute a small 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 the 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 codes 63047 and 63048 due to similarity of service. 
We have received new RUC recommendations 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 final 
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 outpatient 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 
explained that since CPT code 64617, chemodenervation of the larynx, 
includes EMG guidance when furnished we determined 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 procedure)) 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 explained in 
the CY 2014 final rule with comment period, we refined the RUC-
recommended work RVUs for these add-on codes by subtracting the RVUs to 
account for 19 minutes of pre-service time and the decrease in time for 
furnishing the 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)), which 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. One 
commenter stated that the work RVU for the predecessor code, CPT code 
64614, did not take into account the full level of intensity, time, and 
work that it takes to perform the service. 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 RUC 
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 discounted 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 comments we are finalizing the 
interim final work RVUs and time for these codes. We continue to 
believe that our valuations for this family take into account the full 
level of intensity, time, and work that are required 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 value 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)
    After it was identified as a potentially misvalued code pursuant to 
the CMS high expenditure screen, CPT code 69210, which describes 
removal of impacted cerumen, was revised from being applicable to ``1 
or both ears'' to a unilateral code effective January 1, 2014. For 
Medicare purposes we limited the code to billing once whether it was 
furnished unilaterally or bilaterally because we believed the procedure 
would typically be furnished in both ears as the physiologic processes 
that 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 that 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 clarification or if not, that we provide further guidance as to how 
this procedure should be billed using the new code.
    Response: We continue to believe that the procedure will be 
furnished in both ears as the physiologic processes that create cerumen 
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 (MRI) Brain (CPT Codes 77001, 77002, 
and 77003)
    As detailed in the CY 2014 final rule with comment period, we 
agreed with the RUC-recommended values for CPT codes 77001, 77002 and 
77003 but were concerned that the recommended intraservice times for 
all three codes was generally higher than the procedure codes with 
which they were typically billed. We sought additional public comment 
and input from the RUC and other stakeholders regarding the appropriate 
relationship between the intraservice time associated with fluoroscopic 
guidance and the intraservice time of the procedure codes with which 
they are typically billed.
    Comment: Some commenters disagreed with 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 believed that the combinations being used to support this 
concern were not appropriate, and they requested 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 for

[[Page 67638]]

CPT code 77001, 77002, and 77003, respectively.
    Response: We continue to have concerns regarding the appropriate 
relationship between the intraservice time associated with fluoroscopic 
guidance and the intraservice time of the procedure codes with which 
they are typically billed and will continue 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. For 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 
believed 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 portion 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.
    Comment: Multiple commenters objected to CMS's decision to assign a 
PFS status indicator of ``I'' to code 88375, stating that the code 
already includes distinctions that would prevent a physician from 
billing the code when it would double count work. The commenters urge 
CMS to assign CPT code 88375 a Medicare status of A (Active Code), and 
to immediately publish RVUs associated with the service.
    Response: In our re-review of this procedure and consideration of 
the information provided by commenters, we believe the coding is 
adequate to avoid double payment for a portion of the service. 
Accordingly, we assigned a Medicare status indicator of A (Active). To 
value this service, we based the RVUs on those 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 RVU 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 identical 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 the interim final work RVUs 
assigned to CPT codes 92523 and 92524, saying they based on inaccurate 
assumptions. Commenters stated that survey respondents appropriately 
took time and effort into account when valuing CPT code 92523 but had 
difficulty using a time-based reference code to value the RVU of an 
untimed code like CPT code 92523. Commenters noted that the HCPAC 
acknowledged that the work of the second hour involved in CPT code 
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 and failed 
to recognize the more difficult aspects of performing the service 
compared to that of CPT code 92522. Commenters requested 
reconsideration of CPT codes 92523 and 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 for this CPT code because those surveyed did not 
consider all the work necessary to perform the 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. Therefore, 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 Transcatheter Closure (CPT Code 93582)
    As detailed in the CY 2014 final rule with comment period, we 
reviewed new CPT code 93582. Although the RUC compared this code to CPT 
code 92941 (percutaneous transluminal revascularization of acute total/
subtotal occlusion during acute myocardial infarction, coronary artery 
or coronary), which has a work RVU of 12.56 and 70 minutes of 
intraservice time, it recommended a work RVU of 14.00, the survey's 
25th percentile. We agreed with the RUC that CPT code 92941 is an 
appropriate comparison code and believed that due to the similarity in 
intensity and time that the codes should be valued 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 concluded 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 work 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 
intensity and time and, as a result, the codes should be valued with 
the same work RVU. Therefore, 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 extremity 
arteries or arterial bypass grafts; unilateral or limited study), did 
not maintain the appropriate relativity within the family and referred 
the entire family to the RUC to assess relativity among the codes and 
then recommend appropriate work RVUs. We also requested that the RUC 
consider CPT codes 93886 (Transcranial Doppler study of the 
intracranial arteries; complete study) and 93888 (Transcranial Doppler 
study of the

[[Page 67639]]

intracranial arteries; limited study) in conjunction 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 original 
request to the RUC. 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 Consultative 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 
services are always bundled into payment for other services, which are 
not specified. If RVUs are 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 Medicare pays for telephone consultations regarding beneficiary 
services as a part of other services furnished 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 
services to contact between nurses and patients in justifying its 
decision to bundle the services in with other work, and 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 expertise in areas where timely face-to-
face service is not a viable option. The commenter urged that the 
status of these services be changed to ``Active,'' or at least ``Non-
covered,'' and that the RUC-recommended values for these services be 
published.
    Response: Medicare pays for telephone consultations regarding 
beneficiary 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 Interim Direct PE Inputs
i. Background and Methodology
    In this section, we address interim 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 
Web site under the downloads at http://www.cms.gov/PhysicianFeeSched/PFSFRN/list.asp#TopOfPage.
    On an annual basis, the RUC provides CMS with 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 reflect our estimate of the PE resources 
required for the service. We also confirm whether CPT codes 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 refinements to the 
RUC-recommended direct PE inputs, as well as the reasons for 
refinements to particular inputs. In the following sections, we respond 
to the comments we received regarding common refinements we made based 
on established principles or policies. Following those discussions, we 
summarize and respond to comments received regarding other refinements 
to particular codes.
    We note that the interim final direct PE inputs for CY 2014 that 
are being finalized for CY 2015 are displayed in the final CY 2015 
direct PE input database, available on the CMS Web site 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 this 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 makes 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 inputs. We recognize that we make assumptions about 
what is typical, and note that we welcome objective data that provides 
information about the typical case. We prefer that this information be 
submitted through the notice and comment rulemaking process. We also 
refer interested stakeholders to section II.F. of this final rule with 
comment period, in which we provide extensive discussion of the changes 
to the process that we are finalizing for valuing new, revised, and 
potentially misvalued codes.
ii. Common Refinements
(1) Equipment Time
    Prior to CY 2010, the RUC did not generally provide CMS with 
recommendations regarding equipment time inputs. In CY 2010, in the 
interest of ensuring the greatest possible degree of accuracy in 
allocating equipment minutes, we requested 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 correspond to the service 
period portion of the clinical labor times. We have clarified this 
principle, 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 procedure. For services in which we allocate cleaning time 
to portable equipment items, because the equipment does 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 for other patients during that time. In addition, 
when a piece of equipment is typically used during any additional 
visits included in the global period for a service, the equipment time 
would also reflect that use.
    We believe that certain highly technical pieces of equipment and 
equipment rooms are less likely to be used during all of the pre-
service or post-service tasks performed by clinical labor staff on the 
day of the procedure

[[Page 67640]]

(the clinical labor service period) and are typically available for 
other patients even when one member of clinical staff may be occupied 
with a pre-service or post-service task related to the procedure.
    Some commenters have repeatedly objected to our rationale for 
refinement of equipment minutes on this basis. We acknowledge the 
comments we received reiterating those objections to this rationale and 
refer readers to our extensive discussion in response to those 
objections in the CY 2012 PFS final rule with comment period (76 FR 
73182). In the following paragraphs, we address new comments on this 
policy.
    Comment: A commenter indicated that CMS removed 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 this 
assumption. The commenter further stated that CMS did not articulate 
the connection between the relevant data that the Administrative 
Procedures Act (APA) requires CMS to consider and the conclusion that 
CMS reached. The commenter indicated that they conducted a survey of a 
significant number of providers, in which most providers indicated that 
they performed 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 included. 
Statements regarding the existence of data to support commenters' 
assertions do not provide us with information to support conclusions 
based on the data. We acknowledge that we make assumptions about 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 reviewing survey data that address multiple 
points of our assumptions regarding high-cost equipment, including how 
many procedures are furnished in a day, how often the equipment is 
being used, and other such information.
    Comment: A commenter stated that CMS should publish, on a quarterly 
basis, refinements to the equipment times, rather than waiting until 
the final rule to publish these changes.
    Response: We appreciate the commenter's concern 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 inputs on a quarterly basis, we do not have 
information to publish on a quarterly basis. Rather, we have reviewed 
and refined practice expense recommendations from the RUC on an annual 
basis for the subset of codes for which recommendations have been 
provided to us. Because 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 this 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 changes prior to the publishing 
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 the 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 education 
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 those procedures. We also consider the level of 
portability (including the level of difficulty involved in cleaning the 
equipment item) to determine whether an item could be easily 
transferred 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 equipment 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 highly 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 and consider the overlap 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 the RUC, we make this 
determination. To provide stakeholders with examples of the types of 
equipment items that are and are not considered highly technical, we 
have listed several items below and indicated whether they are 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   ER097....................         600,272.00  Chair, medical recliner.  EF009...................          829.03
 SPECT CT.
--------------------------------------------------------------------------------------------------------------------------------------------------------

(2) Standard Tasks and Minutes for Clinical Labor Tasks
    In general, the pre-service, service period, and post-service 
clinical labor minutes associated with clinical labor inputs in the 
direct PE input database 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 procedure, its typical setting, its global period, and the 
other procedures 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

[[Page 67641]]

the RUC-recommended exceptions, we refine the interim final direct PE 
inputs to match the standard times for those tasks. In addition, in 
cases when a service is typically billed with an E/M, we remove the 
pre-service clinical labor tasks to avoid duplicative inputs and to 
reflect the resource costs of furnishing 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 staff 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 
clinical labor tasks as direct inputs.
(3) Equipment Minutes for Film Equipment Inputs
    In section II.A. of this final rule with comment period, we 
finalize our proposal to accept the RUC recommendation to remove inputs 
associated 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 this final rule with comment period, 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 inputs for services that 
contain the standard moderate sedation input package, we refined the 
RUC's recommendation by removing the stretcher (EF018) and adjusting 
the standard moderate 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 moderate 
sedation equipment standard times, since it decreased the time 
allocated to these equipment items.
    Response: We note that for moderate sedation procedures, the 
equipment time is tied to the RN time rather than to the entire service 
period. Specifically, this time includes 2 minutes for sedate/apply 
anesthesia, 100 percent of physician intraservice time, and 60 minutes 
of post-procedure time for every 15 minutes 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 endoscopic 
procedures, the stretcher is typically used throughout the entire 
procedure, as well as during post-procedure monitoring. Other 
commenters indicated that the stretcher is required 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 sedation 
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 revised package would be applied to relevant 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 incorporating the stretcher, we 
have removed the power table for procedures in which 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 
containing the standard moderate sedation inputs, with the additional 
refinements of including the stretcher for all of these procedures, 
removing the power table for the codes noted in Table 17 as containing 
a 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 
input database, available on the CMS Web site under the downloads for 
the CY 2015 PFS final rule at www.cms.gov/PhysicianFeeSched/.

                                    Table 17--CPT Codes With Stretcher Added
----------------------------------------------------------------------------------------------------------------
                                                                   Moderate
             CPT Code                    Short descriptor          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                   272
                                    venous.
37242............................  Vasc embolize/occlude                   342
                                    artery.
37243............................  Vasc embolize/occlude organ             362
37244............................  Vasc embolize/occlude bleed             332
43200............................  Esophagoscopy flexible                   77  Yes.
                                    brush.
43201............................  Esoph scope w/submucous inj              80  Yes.
43202............................  Esophagoscopy flex biopsy..              82  Yes.
43206............................  Esoph optical                            92  Yes.
                                    endomicroscopy.
43213............................  Esophagoscopy retro balloon             107  Yes.
43215............................  Esophagoscopy flex remove                82  Yes.
                                    fb.
43216............................  Esophagoscopy lesion                     84  Yes.
                                    removal.
43217............................  Esophagoscopy snare les                  92  Yes.
                                    remv.
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                 107  Yes.
                                    exam.

[[Page 67642]]

 
43232............................  Esophagoscopy w/us needle               122  Yes.
                                    bx.
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                  77  Yes.
                                    pass.
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.             167
----------------------------------------------------------------------------------------------------------------

(5) Recommended PE Inputs Not Used in the Calculation of Practice 
Expense Relative Value Units
    In preparing the Direct Practice Expense Input database for CY 
2014, we noted that in some cases, there were recommended inputs in the 
database that were not used in the calculation of the PE RVUs. In cases 
where inputs are included for a particular service in a particular 
setting, but that service is not priced in that setting, the inputs are 
not used. In the documentation files for the CY 2014 final rule, we 
stated, ``In previous years, we have displayed recommended inputs even 
when these inputs are not used in the calculation of the practice 
expense relative value units. We note that we are no longer displaying 
such inputs in these public use files since they are not used in the 
calculation of the practice 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 objecting to refinements 
made based on ``CMS clinical review'' (including our determination that 
certain recommended PE inputs were duplicative of others already 
included with the service), statutory requirements, or established 
principles and policies under the PFS. We note that for many of our 
refinements, the specialty societies that represent the practitioners 
who furnish the service objected to most of these refinements for the 
general reasons described above or for the reasons we respond to in the 
``background and methodology'' portion of this section, or stated that 
they supported the RUC recommended PE inputs. Below, we respond to 
comments in which commenters address specific CPT/HCPCS codes and 
explain their objections to our refinements by providing us with new 
information supporting the inclusion of the items and/or times 
requested. When discussing these refinements, rather than listing all 
refinements made for each service, we discuss only the specific 
refinements for which commenters provided supporting information. We 
indicate the presence of other refinements by noting ``among other 
refinements'' after delineating the specific refinements for a 
particular service or group of services. For those comments that stated 
that an item was ``necessary for the service'' and provided no 
additional rationale or information, we conducted further review to 
determine whether the inputs as refined were appropriate and concluded 
that the inputs as refined were indeed appropriate. We also note that 
in many cases, commenters objected to our indication 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 the duplicative nature of inputs unless 
commenters specifically explain why the relevant items are not 
duplicative with the identical items 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 commenting that 
the item is not duplicative. Finally, we note that in some cases we 
made proposals related to comments received in response to the CY 2014 
final rule with comment period. In cases 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 refinements to equipment 
times for many procedures for which commenters indicated that the 
equipment time for the procedure should include the time that the 
equipment is unavailable for other patients, including while preparing 
equipment, positioning the patient, assisting the physician, and 
cleaning the room. Commenters also requested that we indicate which 
clinical labor tasks should be included in calculating the equipment 
time for highly technical equipment.
    Response: As stated above, we agree with commenters that the 
equipment time should include the times within the intra-service period 
when a clinician is using the piece of equipment plus any

[[Page 67643]]

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 number of clinical labor minutes included in the 
service period to the equipment items. However, as we have explained, 
the clinical labor service period includes minutes based on some 
clinical labor tasks associated with pre- and post-service activities 
that we do not believe typically preclude equipment items from being 
used in furnishing services to other patients because these activities 
typically occur 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 other patients. In response to commenters 
request for clarification, Table 19 lists the standard clinical labor 
tasks to be included in the calculation of time allocated to highly 
technical equipment. We note that in some cases, some specialized 
intraservice clinical labor tasks are also included in the equipment 
time calculations; we have not detailed every possible case in this 
table.

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 procedure 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 refinements to clinical 
labor times for several procedures, in which commenters indicated that 
CMS reduced the clinical labor minutes inappropriately for tasks 
related to film inputs, 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 
``Retrieve prior appropriate imaging exams.''
    Response: The surveyed times referenced by the commenters refer to 
the clinical labor tasks associated with film technology. In reviewing 
the times associated 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 labor tasks for all interim final 
codes to be consistent with the RUC recommendations regarding clinical 
labor tasks 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 inputs are 
presented side-by-side, along with the range of typical times, in Table 
20. The specific interim final codes and their time changes are listed 
in Table 21.

                        Table 20--Clinical Labor Tasks Associated with Digital Technology
----------------------------------------------------------------------------------------------------------------
                                 Clinical labor task: film     Typical       Clinical labor task:       Typical
        Service period                    inputs               minutes          digital inputs          minutes
----------------------------------------------------------------------------------------------------------------
Pre-Service...................  Retrieve prior appropriate  4 to 7......  Availability of prior                2
                                 imaging exams and hang                    images confirmed.                   2
                                 for MD review, verify                    Patient clinical
                                 orders, review the chart                  information and
                                 to incorporate relevant                   questionnaire reviewed by
                                 clinical information and                  technologist, order from
                                 confirm contrast protocol                 physician confirmed and
                                 with interpreting MD/                     exam protocoled by
                                 Retrieve Prior Image for                  radiologist.
                                 Comparison.
Service Period: Post-Service..  Process Images, complete    4 to 20.....  Technologist QC's images             2
                                 data sheet, present                       in PACS, checking for all           2
                                 images and data to the                    images, reformats, and              1
                                 interpreting physician/                   dose page.
                                 Process films, hang films                Review examination with
                                 and review study with                     interpreting MD.
                                 interpreting MD prior to                 Exam documents scanned
                                 patient discharge.                        into PACS. Exam completed
                                                                           in RIS system to generate
                                                                           billing process and to
                                                                           populate images into
                                                                           Radiologist work queue.
----------------------------------------------------------------------------------------------------------------


        Table 21--Interim Final Codes with Adjusted Clinical Labor Times Due to Film-to-Digital Migration
----------------------------------------------------------------------------------------------------------------
                                                                    Total film
               CPT code                         CMS code             task time     Total digital    Time change
                                                                      (2014)         task time
----------------------------------------------------------------------------------------------------------------
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

[[Page 67644]]

 
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's recommendations for supply item LMX 4% anesthetic 
cream (SH092).
    Comment: Commenters indicated that the quantity of cream units in 
CPT code 17003 created a rank order anomaly with CPT codes 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 contain a quantity of 1 gram in order to avoid the rank 
order anomaly. After consideration of the comments received, we are 
finalizing the CY 2014 interim final direct 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 other biopsy 
supplies already included 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 determined that these items served clinical functions to 
items already 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 localization set (trocar)'' and 
``tissue filter,'' stating that the trocar is used to target the biopsy 
on the correct lesion, and the tissue filter is necessary to remove the 
collected core samples from the collection chamber. Commenters 
described the importance of the ``breast biopsy device (coil), '' which 
is used to move one breast out of the way and the ``breast biopsy 
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 designed 
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 handpiece,'' ``vacuum line assembly,'' ``tissue 
filter,'' and ``trocar,'' are duplicative of items already included in 
this procedure. We do note that we have used the invoice to create a 
price for equipment item ``Breast biopsy device (coil)'' (EQ371) at a 
price of $12,238. After 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 breast biopsy codes do not 
distinguish between the type of biopsy device used for the procedure, 
and that the cost of using the vacuum-assisted biopsy device (including 
a Mammotome probe, a Mammotome 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 (mechanical) core needle 
biopsy. The commenter noted that vacuum-assisted biopsy devices are 
predominantly 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. 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

[[Page 67645]]

points out, the vacuum-assisted biopsy devices are typically used, we 
include these items as direct PE inputs.
    In reviewing the breast biopsy codes, we noted that we 
inadvertently 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 consideration of the comments received, we are 
finalizing the CY 2014 interim final direct 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 Inadvertently 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 
refining the nurse blend (L037D) clinical labor time associated with 
task ``Monitor pt. following service/check tubes, monitors, drains'' 
from 15 minutes to 5 minutes.
    Comment: Commenters stated that CMS should maintain consistency in 
the direct PE inputs across services by allocating the standard 15 
minutes for every hour of post-procedure monitoring time. Commenters 
indicated 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 monitoring time for 
moderate sedation, and a standard 15 minutes per hour of post-procedure 
monitoring time unrelated to moderate sedation. We understand the 
commenter's position to mean that there is 60 minutes of post-procedure 
monitoring required for these services (in accordance with 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 monitoring 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 specialty society is recommending post-
procedure monitoring unrelated to moderate sedation, it is important 
that the recommendation clearly indicates the reason for the monitoring 
and the relationship between the clinical staff time and the monitoring 
time. After consideration of the 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 Activated Cardiac Event 
Recorder (CPT Codes 33282 and 33284)
    In the CY 2013 final rule with comment period, 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.
    Comment: A commenter expressed disappointment that CMS did not 
price these services in the nonfacility setting but did not provide 
further information about this decision.
    Response: We received recommendations from the RUC for CPT codes 
33282 and 33284 that did not include nonfacility inputs. Stakeholders 
who are interested in providing information about the direct PE inputs 
used in furnishing these services are welcome to submit this 
information to us; information about the level of information we seek 
is available to stakeholders in the sample PE worksheet available on 
the CMS Web site 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 Intravascular 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 recommendation did not indicate 
the items on the PE worksheet with which they were associated.
    Comment: The specialty society representing practitioners 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 society's clarification of 
the RUC recommendation. We will add item ``balloon implantable stent'' 
at a price of $1,500, and remove the proxy item SD152. We note that 
when line items 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 
RUC 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 and 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 
clinical 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 procedure 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 matter of relativity throughout 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 exceptions to this rule are for equipment 
items that are tied to specific clinical

[[Page 67646]]

labor tasks, such as cleaning the surgical instrument 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 the final rule with comment 
period that the information included with the RUC recommendation 
suggested that the biopsy forceps was reusable (as suggested by the 
cleaning time mentioned in this comment). As such, we have created a 
new equipment item based on the invoice provided with the 
recommendation and assigned 46 minutes to this equipment item. However, 
since we did not receive a paid invoice with this item, we will price 
it at $0 until we receive a paid invoice.
    After consideration of the comments received, we are finalizing the 
CY 2014 interim final direct PE inputs for CPT codes 43197 and 43198 as 
established, with the additional refinement of including 46 minutes for 
the reusable biopsy forceps.
(g) Esophagoscopy/Esophagoscopy Gastroscopy 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 for 
patient safety reasons. Other stakeholders, specifically, several 
specialty societies with whom we met during the comment period, 
informed us that one suction canister is sufficient 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 canister is typical.
    In establishing interim final direct PE inputs for CY 2014, CMS 
refined the RUC's recommendations for CPT codes 43201 by removing 
needle, micropigmentation (tattoo) (SC079), as the needle required for 
this procedure needs to go through an endoscope, and no invoice was 
provided for this item.
    Comment: Commenters indicated that the tattoo needle was required 
to mark the site for injection.
    Response: We did not receive an invoice for the tattoo 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 endoscopy 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 appropriate to 
include this supply item for these procedures. We will include the 
supply item ``cup, biopsy-specimen 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 include ``endoscopic balloon, 
dilation'' (SD287) rather than a proxy, as this supply item is now 
included in the database.
    Response: After receiving clarification regarding this request, we 
agree with commenters that SD287 is an appropriate supply input for 
this procedure. Therefore, we will include SD287 for CPT code 43220.
    In establishing interim final direct PE inputs for CY 2014, CMS 
refined the RUC's 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 would 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 additional 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 disinfector is a 
necessary part of all endoscopic procedures for sanitary and safety 
reasons, 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 procedure; the mobile stand overlaps with the 
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 finalizing 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

[[Page 67647]]

instrument 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 surgical 
instrument cleaning package is necessary to ensure proper adherence of 
the electrodes.
    Response: In general, as a matter of relativity throughout 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 exceptions to this rule are for equipment 
items which are tied to specific clinical labor tasks, such as cleaning 
the surgical instrument 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 consideration of the comments 
received, we are finalizing 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 removing the time associated with clinical labor task 
``Complete botox log,'' as well as reducing the L037D time for clinical 
labor ``assist physician performing procedure'' for CPT code 64616, 
among other refinements.
    Comment: One commenter opposed our adjusting the minutes allocated 
to the exam table. Commenters stated that the reference code, 64615, 
included three minutes of clinical labor time for ``complete botox 
log,'' and requested that they be included since they are in the 
reference code. One commenter asked whether CMS planned 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 commenters pointing out the three minutes of time 
inadvertently allocated for ``complete botox log'' in the reference 
code, 64615, and will consider this issue in future rulemaking. We note 
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 records. The use of a different location for 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 
disagreed 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 time allocated for 
assist physician, we determined that 7 minutes is actually appropriate 
for the assist physician task.
    After consideration of the comments 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 minutes for the exam table as indicated above and 
adding 2 minutes of clinical labor for 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 ``escort 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 associated 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 was last 
reviewed in 2002. We noted that we believe there should be no 
significant difference between the time to acquire images for an MRI of 
the brain and an MRI of the spine, and that, rather than rely on very 
old survey data, it would be appropriate to crosswalk the time 
associated with the MRI of the spine 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 necessary 
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 
previously reviewed in 2002. Therefore, since this activity does not 
reflect a newly added clinical labor task, we agree with commenters 
that it would be appropriate to include 2 minutes for this clinical 
labor task.
    Comment: Commenters stated that the supplies 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), when the correct supply 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 the 
corresponding supply items removed due to redundancy.

              Table 23--Items Removed for Redundancy and Parallel 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

[[Page 67648]]

 
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 
clinical 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 clinical 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 necessary 
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 
previously reviewed in 2002. Therefore, since this activity does not 
reflect a newly added clinical labor task, we agree with commenters 
that it would be appropriate to include 2 minutes for this clinical 
labor task.
    Comment: A commenter noted that CMS did not include a contrast 
imaging pack, which includes supplies necessary for contrast enhanced 
studies.
    Response: In section II.B. of this final rule with comment period, 
we finalized our policy to add a contrast imaging pack to be used for 
imaging services with contrast. Therefore, we will include the contrast 
supply pack (CMS 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 ``assist physician in 
performing procedure,'' and since the time for 36245 was reduced from 
73 to 45 minutes, 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-related, 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 
updated information are appropriate. We continue to believe that it is 
appropriate for the intraservice times for 36245 and 75726 to continue 
to correspond to one another, as they are frequently furnished 
together. After consideration of the comments received, we are 
finalizing the CY 2014 interim final direct PE inputs for CPT code 
75726 as established.
(o) Radiation Treatment Delivery (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 the 
equipment time for ``pulse oximeter w-printer'' (EQ211) and ``SRS 
system, SBRT, six 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 associated 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 these equipment items. After 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 anomalous supply inputs 
included in the direct PE database, which affected 77422 and 77423, 
among other services.
    Comment: Commenters indicated that upon reviewing the inputs for 
these services, they noted that the Record and Verify System and the 
laser targeting system were missing in both of these services, despite 
being in the original 2005 recommendation.
    Response: We appreciate the commenters' attention to detail. 
However, as indicated elsewhere, we do not believe that the record and 
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 laser targeting system continues to be an appropriate 
input for these services. Therefore, we request that the RUC examine 
the inputs for these services 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'' (ER035) and removing the time associated with clinical labor 
task ``clean scope,'' among other refinements.
    Comment: Commenters indicated that the appropriate lines were not 
used to calculate the recommended equipment times, including cleaning 
the scope and check dressing.
    Response: Upon reviewing the comments, we re-examined the equipment 
time calculation and

[[Page 67649]]

continue to believe that the time allocated to this equipment item is 
appropriate. We note that there is no scope used in this procedure, so 
time to clean the scope is unnecessary. After consideration of the 
comments 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 container is a safety 
device used when a source must be retrieved manually. Commenters 
indicated that it is a mobile 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. Commenters asked that we reclassify this item as a direct 
input.
    Response: In our clinical review, we reviewed the work vignettes 
for these procedures, which did not include the use of the ``emergency 
service container--safety kit'' as a part of the procedure. Although we 
acknowledge that the emergency service container safety kit needs to be 
readily available during the procedure, we note 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'' equipment in the CY 2001 
PFS proposed rule (65 FR 44187).
    When reviewing the interim final direct PE inputs for these 
services, we noted that the specialty societies conducted a survey of 
the technicians, which revealed higher procedure times than the current 
procedure times. However, since the RUC indicated that 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 indication that the survey was flawed, the 
specialty society should recommend the use of the surveyed procedure 
times. In doing so, the specialty society would give CMS the 
opportunity to consider the information provided alongside the RUC 
recommended times. We believe that surveys of technicians have the 
potential to be more accurate, rather than less accurate, than those of 
physicians, as the technicians do not have incentives to increase the 
surveyed time. We suggest that rather than attempting to insert items 
that are not standard in the PE methodology, that specialty societies 
make a strong, data-driven case, for why the survey times are correct.
    Comment: A commenter noted that there have been significant 
reductions 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 after review of the methodology and data.
    Response: We note that reductions to CPT codes are made on the 
basis that they are potentially misvalued. We do not typically 
transition 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 codes 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 the 
clinical labor time associated with several clinical labor tasks, 
including ``Order, restock, and distribute specimen containers with 
requisition forms,'' ``Perform screening function (where applicable),'' 
``Confirm patient ID, organize work, verify and review history,'' and 
``Enter screening diagnosis in laboratory information system, complete 
workload recording logs, manage any relevant utilization review/quality 
assurance activities and regulatory compliance documentation and 
assemble and deliver slides with paperwork to pathologist.''
    Comment: Commenters pointed out that CPT code 88112 was 
inadvertently listed in Table 28 in the CY 2014 final rule with comment 
period as being unrefined by CMS. Commenters also opposed the 
reductions in clinical labor time, and noted that the PE subcommittee 
thoroughly reviewed these inputs.
    Response: We apologize for the inadvertent inclusion of CPT code 
88112 in Table 28 of the CY 2014 final rule with comment period. We re-
examined the clinical labor tasks in light of the comments received and 
noted that the clinical labor task ``Order, restock, and distribute 
specimen containers with requisition forms'' is not a clinical labor 
task associated with furnishing a service to a particular patient, and 
is therefore allocated in the indirect practice expense. Clinical labor 
task ``Perform screening function (where 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 workload 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 rule with comment period (78 
FR 74308) for a discussion regarding quality assurance activities. 
After consideration of the comments received, we are finalizing the CY 
2014 interim final direct PE inputs for CPT code 88112.
    Comment: One commenter noted that the refinements 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 service than CPT code 88112. Specifically, commenters stated 
that it is illogical for a cytology specimen processing technique that 
involves an additional step that requires materially more resources to 
have an RVU that is less than an associated technique that requires 
fewer resources, and expressed concerns about the potential for 
misreporting.
    Response: We appreciate this commenter bringing this rank order 
anomaly to our attention. As indicated in section II.B. of this final 
rule with comment period, we are referring this code to the RUC as 
potentially misvalued based on the information received from the 
commenter.
(s) Duplex Scans (CPT Codes 93880 and 93882)
    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 grade)'' (ED034) and ``video printer, color (Sony medical 
grade)'' (ED036), and refining the equipment time for ``computer 
desktop, w-monitor''

[[Page 67650]]

(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 period. Commenters also stated that the refinements were 
expressed as a final decision effective January 1, 2014.
    Response: The equipment item ``room, vascular ultrasound'' (EL016) 
contains ``room, ultrasound general'' (EL015), which contains both 
``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 section II.F. of this rule for further 
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 final 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, testing 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 restore the time 
previously removed.
    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 CPT codes 95816, 95819, and 95822 as 
established, with the additional refinement of assigning the 
intraservice time to EQ330.
(u) Anogenital Examination With Colposcopic 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 (HCPCS 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 
services. We acknowledge comments regarding the refinements CMS made to 
these inputs, as well as comments indicating that the direct practice 
expense inputs for these procedures implied that the reporting would be 
different than the reporting implied by the code descriptors. We note 
that the RUC has subsequently reviewed CPT codes 88342 and 88343 again 
and we present the interim final values for 2015 in this final rule 
with comment period. Therefore, we will not address specific comments 
regarding G0461 and G0462 except, as discussed below, as they pertain 
to errors identified 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 measure established in the 
direct PE inputs database for SL486, which costs $65.63 for 250 tests, 
the per test quantity should be 1, rather than 0.004.
    Response: We agree with commenters that these prices were 
calculated incorrectly and have made the adjustments to the direct PE 
database.
c. Finalizing CY 2014 Interim Malpractice Crosswalks for CY 2015
    In accordance with our malpractice methodology, we adjusted the 
malpractice RVUs for the CY 2014 new/revised/potentially misvalued 
codes for the difference in work RVUs (or, if greater, the clinical 
labor portion of the PE RVUs) between the 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 interim final cross 
walks. As detailed in the CY 2014 final rule with comment period, we 
assigned malpractice crosswalk of CPT code 31575 (Laryngoscopy, 
flexible fiberoptic; diagnostic) to CPT codes 43191-43195 and CPT code 
31638 (Bronchoscopy, rigid or flexible, including fluoroscopic 
guidance, when performed; with revision of tracheal or bronchial stent 
inserted at previous session (includes tracheal/bronchial dilation as 
required)) to CPT code 43196.
    Comment: A commenter said that the established PLI crosswalk, CPT 
code 31575, for CPT code 43191-43196 is not appropriate because the 
latter services have a life-threatening risk to patients and the same 
is not true for CPT 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, 
including fluoroscopic guidance, when performed; diagnostic, with cell 
washing, when performed (separate procedure)) for CPT code 43191, 31625 
(Bronchoscopy, rigid or flexible, including fluoroscopic guidance, when 
performed; with bronchial or endobronchial biopsy(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 bronchial stent inserted at 
previous session (includes tracheal/bronchial dilation as required)) 
for CPT codes 43194 and 43196.
    Response: We continue to believe that our assigned CY 2014 
malpractice 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 interim final malpractice 
crosswalks and are finalizing them without modification for CY 2015.
    The malpractice RVUs for these services are 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 details on the review, 
see section II.C.
d. Other New, Revised or Potentially Misvalued 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

[[Page 67651]]

specifically discussed in this CY 2015 PFS final rule with comment 
period, we are finalizing for CY 2015, without modification, the CY 
2014 interim final or CY 2014 proposed work RVUs, malpractice 
crosswalks, and direct PE inputs. Unless otherwise indicated, we agreed 
with the time values recommended by the RUC or HCPAC for all codes 
addressed in this section. The time values for all codes are listed in 
a file called ``CY 2014 PFS Work Time,'' available on the CMS Web site 
under downloads for the CY 2015 PFS final rule with comment period at 
http://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/PhysicianFeeSched/PFS-Federal-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 values, see section II.Bof this final rule with 
comment period.

                       Table 24--CY 2015 Final Work RVUS for Codes With Proposed Work RVUs
----------------------------------------------------------------------------------------------------------------
                                                                                      Proposed  CY
    HCPCS  code                       Long descriptor                   CY 2014 WRVU   2015  work   CY 2015 work
                                                                                           RVU           RVU
----------------------------------------------------------------------------------------------------------------
G0389..............  Ultrasound, B-scan and/or real time with image            0.58          0.58          0.58
                      documentation; for abdominal aortic aneurysm
                      (AAA) screening.
G0416..............  Surgical pathology, gross and microscopic                 3.09          3.09          3.09
                      examination for prostate needle biopsies, any
                      method;.
G0473..............  Face-to-face behavioral counseling for obesity,            (1)           N/A          0.25
                      group (2-10), 30 minutes.
62310..............  Injection(s), of diagnostic or therapeutic                1.18          1.91          1.91
                      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.
62311..............  Injection(s), of diagnostic or therapeutic                1.17          1.54          1.54
                      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).
62318..............  Injection(s), including indwelling catheter               1.54          2.04          2.04
                      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).
62319..............  Injection(s), including indwelling catheter               1.50          1.87          1.87
                      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).
77055..............  mammography; unilateral,.........................          .70           .70           .70
77056..............  mammography; bilateral...........................          .87           .87           .87
77057..............  screening mammography, bilateral (2-view film              .70           .70           .70
                      study of each breast).
99490..............  Chronic care management services, at least 20              New           .61           .61
                      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/
                      decompensation, or functional decline;
                      comprehensive care plan established,
                      implemented, revised, or monitored.
----------------------------------------------------------------------------------------------------------------
\1\ New.

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 CY 2015. These values are subject to public 
comment. 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 recommended by the 
RUC or for which we do not have RUC recommendations.

            Table 25--CY 2015 Interim Final Work RVUS for New/Revised or Potentially Misvalued Codes
----------------------------------------------------------------------------------------------------------------
                                                                      RUC/HCPAC
HCPCS Code               Long descriptor              CY 2014 WRVU   recommended     CY 2015        CMS time
                                                                      work RVU      work RVU       refinement
----------------------------------------------------------------------------------------------------------------
11980.....  Subcutaneous hormone pellet implantation         1.48          1.10          1.10   No
             (implantation of estradiol and/or
             testosterone pellets beneath the skin).
20604.....  Arthrocentesis, aspiration and/or               (\1\)          0.89          0.89   No
             injection, small joint or bursa (eg,
             fingers, toes); with ultrasound
             guidance, with permanent recording and
             reporting.

[[Page 67652]]

 
20606.....  Arthrocentesis, aspiration and/or               (\1\)          1.00          1.00   No
             injection, intermediate joint or bursa
             (eg, temporomandibular,
             acromioclavicular, wrist, elbow or
             ankle, olecranon bursa); with
             ultrasound guidance, with permanent
             recording and reporting.
20611.....  Arthrocentesis, aspiration and/or               (\1\)          1.10          1.10   No
             injection, major joint or bursa (eg,
             shoulder, hip, knee, subacromial
             bursa); with ultrasound guidance, with
             permanent recording and reporting.
20983.....  Ablation therapy for reduction or               (\1\)          7.13          7.13   No
             eradication of 1 or more bone tumors
             (eg, metastasis) including adjacent
             soft tissue when involved by tumor
             extension, percutaneous, including
             imaging guidance when performed;
             cryoablation.
21811.....  Open treatment of rib fracture(s) with          (\1\)         19.55         10.79   Yes
             internal fixation, includes
             thoracoscopic visualization when
             performed, unilateral; 1-3 ribs.
21812.....  Open treatment of rib fracture(s) with          (\1\)         25.00         13.00   Yes
             internal fixation, includes
             thoracoscopic visualization when
             performed, unilateral; 4-6 ribs.
21813.....  Open treatment of rib fracture(s) with          (\1\)         35.00         17.61   Yes
             internal fixation, includes
             thoracoscopic visualization when
             performed, unilateral; 7 or more ribs.
22510.....  Percutaneous vertebroplasty (bone biopsy        (\1\)          8.15          8.15   No
             included when performed), 1 vertebral
             body, unilateral or bilateral
             injection, inclusive of all imaging
             guidance; cervicothoracic.
22511.....  Percutaneous vertebroplasty (bone biopsy        (\1\)          8.05          7.58   No
             included when performed), 1 vertebral
             body, unilateral or bilateral
             injection, inclusive of all imaging
             guidance; lumbosacral.
22512.....  Percutaneous vertebroplasty (bone biopsy        (\1\)          4.00          4.00   No
             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).
22513.....  Percutaneous vertebral augmentation,            (\1\)          8.90          8.90   No
             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.
22514.....  Percutaneous vertebral augmentation,            (\1\)          8.24          8.24   No
             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.
22515.....  Percutaneous vertebral augmentation,            (\1\)          4.00          4.00   No
             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).
22856.....  Total disc arthroplasty (artificial             24.05         24.05         24.05   No
             disc), anterior approach, including
             discectomy with end plate preparation
             (includes osteophytectomy for nerve
             root or spinal cord decompression and
             microdissection); single interspace,
             cervical.
22858.....  Total disc arthroplasty (artificial             (\1\)          8.40          8.40   No
             disc), anterior approach, including
             discectomy 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).
27279.....  Arthrodesis, sacroiliac joint,                  (\1\)          9.03          9.03   No
             percutaneous or minimally invasive
             (indirect visualization), with image
             guidance, includes obtaining bone graft
             when performed, and placement of
             transfixing device.
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   No
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           1.40          1.50          1.40   No
             bronchoscopic diagnostic or therapeutic
             intervention(s) (list separately in
             addition to code for primary
             procedure[s]).
33215.....  Repositioning of previously implanted            4.92          4.92          4.92   No
             transvenous pacemaker or implantable
             defibrillator (right atrial or right
             ventricular) electrode.
33216.....  Insertion of a single transvenous                5.87          5.87          5.87   No
             electrode, permanent pacemaker or
             implantable defibrillator.
33217.....  Insertion of 2 transvenous electrodes,           5.84          5.84          5.84   No
             permanent pacemaker or implantable
             defibrillator.

[[Page 67653]]

 
33218.....  Repair of single transvenous electrode,          6.07          6.07          6.07   No
             permanent pacemaker or implantable
             defibrillator.
33220.....  Repair of 2 transvenous electrodes for           6.15          6.15          6.15   No
             permanent pacemaker or implantable
             defibrillator.
33223.....  Relocation of skin pocket for                    6.55          6.55          6.55   No
             implantable defibrillator.
33224.....  Insertion of pacing electrode, cardiac           9.04          9.04          9.04   No
             venous system, for left ventricular
             pacing, with attachment to previously
             placed pacemaker or implantable
             defibrillator pulse generator
             (including revision of pocket, removal,
             insertion, and/or replacement of
             existing generator).
33225.....  Insertion of pacing electrode, cardiac           8.33          8.33          8.33   No
             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).
33240.....  Insertion of implantable defibrillator           6.05          6.05          6.05   No
             pulse generator only; with existing
             single lead.
33241.....  Removal of implantable defibrillator             3.29          3.29          3.29   No
             pulse generator only.
33243.....  Removal of single or dual chamber               23.57         23.57         23.57   No
             implantable defibrillator electrode(s);
             by thoracotomy.
33244.....  Removal of single or dual chamber               13.99         13.99         13.99   No
             implantable defibrillator electrode(s);
             by transvenous extraction.
33249.....  Insertion or replacement of permanent           15.17         15.17         15.17   No
             implantable defibrillator system, with
             transvenous lead(s), single or dual
             chamber.
33262.....  Removal of implantable defibrillator             6.06          6.06          6.06   No
             pulse generator with replacement of
             implantable defibrillator pulse
             generator; single lead system.
33263.....  Removal of implantable defibrillator             6.33          6.33          6.33   No
             pulse generator with replacement of
             implantable defibrillator pulse
             generator; dual lead system.
33270.....  Insertion or replacement of permanent           (\1\)          9.10          9.10   No
             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.
33271.....  Insertion of subcutaneous implantable           (\1\)          7.50          7.50   No
             defibrillator electrode.
33272.....  Removal of subcutaneous implantable             (\1\)          5.42          5.42   No
             defibrillator electrode.
33273.....  Repositioning of previously implanted           (\1\)          6.50          6.50   No
             subcutaneous implantable defibrillator
             electrode.
33418.....  Transcatheter mitral valve repair,              (\1\)         32.25         32.25   No
             percutaneous approach, including
             transseptal puncture when performed;
             initial prosthesis.
33419.....  Transcatheter mitral valve repair,              (\1\)          7.93          7.93   No
             percutaneous approach, including
             transseptal puncture when performed;
             additional prosthesis(es) during same
             session (list separately in addition to
             code for primary procedure).
33946.....  Extracorporeal membrane oxygenation             (\1\)          6.00          6.00   No
             (ecmo)/extracorporeal life support
             (ecls) provided by physician;
             initiation, veno-venous.
33947.....  Extracorporeal membrane oxygenation             (\1\)          6.63          6.63   No
             (ecmo)/extracorporeal life support
             (ecls) provided by physician;
             initiation, veno-arterial.
33949.....  Extracorporeal membrane oxygenation             (\1\)          4.60          4.60   No
             (ecmo)/extracorporeal life support
             (ecls) provided by physician; daily
             management, each day, veno-arterial.
33951.....  Extracorporeal membrane oxygenation             (\1\)          8.15          8.15   No
             (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).
33952.....  Extracorporeal membrane oxygenation             (\1\)          8.43          8.15   No
             (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).
33953.....  Extracorporeal membrane oxygenation             (\1\)          9.83          9.11   No
             (ecmo)/extracorporeal life support
             (ecls) provided by physician; insertion
             of peripheral (arterial and/or venous)
             cannula(e), open, birth through 5 years
             of age.
33954.....  Extracorporeal membrane oxygenation             (\1\)          9.43          9.11   No
             (ecmo)/extracorporeal life support
             (ecls) provided by physician; insertion
             of peripheral (arterial and/or venous)
             cannula(e), open, 6 years and older.
33955.....  Extracorporeal membrane oxygenation             (\1\)         16.00         16.00   No
             (ecmo)/extracorporeal life support
             (ecls) provided by physician; insertion
             of central cannula(e) by sternotomy or
             thoracotomy, birth through 5 years of
             age.
33956.....  Extracorporeal membrane oxygenation             (\1\)         16.00         16.00   No
             (ecmo)/extracorporeal life support
             (ecls) provided by physician; insertion
             of central cannula(e) by sternotomy or
             thoracotomy, 6 years and older.

[[Page 67654]]

 
33957.....  Extracorporeal membrane oxygenation             (\1\)          4.00          3.51   No
             (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).
33958.....  Extracorporeal membrane oxygenation             (\1\)          4.05          3.51   No
             (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).
33959.....  Extracorporeal membrane oxygenation             (\1\)          4.69          4.47   No
             (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).
33962.....  Extracorporeal membrane oxygenation             (\1\)          4.73          4.47   No
             (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).
33963.....  Extracorporeal membrane oxygenation             (\1\)          9.00          9.00   No
             (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).
33964.....  Extracorporeal membrane oxygenation             (\1\)          9.50          9.50   No
             (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).
33965.....  Extracorporeal membrane oxygenation             (\1\)          3.51          3.51   No
             (ecmo)/extracorporeal life support
             (ecls) provided by physician; removal
             of peripheral (arterial and/or venous)
             cannula(e), percutaneous, birth through
             5 years of age.
33966.....  Extracorporeal membrane oxygenation             (\1\)          4.50          4.50   No
             (ecmo)/extracorporeal life support
             (ecls) provided by physician; removal
             of peripheral (arterial and/or venous)
             cannula(e), percutaneous, 6 years and
             older.
33969.....  Extracorporeal membrane oxygenation             (\1\)          6.00          5.22   No
             (ecmo)/extracorporeal life support
             (ecls) provided by physician; removal
             of peripheral (arterial and/or venous)
             cannula(e), open, birth through 5 years
             of age.
33984.....  Extracorporeal membrane oxygenation             (\1\)          6.38          5.46   No
             (ecmo)/extracorporeal life support
             (ecls) provided by physician; removal
             of peripheral (arterial and/or venous)
             cannula(e), open, 6 years and older.
33985.....  Extracorporeal membrane oxygenation             (\1\)          9.89          9.89   No
             (ecmo)/extracorporeal life support
             (ecls) provided by physician; removal
             of central cannula(e) by sternotomy or
             thoracotomy, birth through 5 years of
             age.
33986.....  Extracorporeal membrane oxygenation             (\1\)         10.00         10.00   No
             (ecmo)/extracorporeal life support
             (ecls) provided by physician; removal
             of central cannula(e) by sternotomy or
             thoracotomy, 6 years and older.
33987.....  Arterial exposure with creation of graft        (\1\)          4.04          4.04   No
             conduit (eg, chimney graft) to
             facilitate arterial perfusion for ecmo/
             ecls (list separately in addition to
             code for primary procedure).
33988.....  Insertion of left heart vent by thoracic        (\1\)         15.00         15.00   No
             incision (eg, sternotomy, thoracotomy)
             for ecmo/ecls.
33989.....  Removal of left heart vent by thoracic          (\1\)          9.50          9.50   No
             incision (eg, sternotomy, thoracotomy)
             for ecmo/ecls.
34839.....  Physician planning of a patient-specific        (\1\)              C            B   N/A
             fenestrated visceral aortic endograft
             requiring a minimum of 90 minutes of
             physician time.
34841.....  Endovascular repair of visceral aorta                C             C             C  N/A
             (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 (superior
             mesenteric, celiac or renal artery).
34842.....  Endovascular repair of visceral aorta                C             C             C  N/A
             (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]).

[[Page 67655]]

 
34843.....  Endovascular repair of visceral aorta                C             C             C  N/A
             (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]).
34844.....  Endovascular repair of visceral aorta                C             C             C  N/A
             (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]).
34845.....  Endovascular repair of visceral aorta                C             C             C  N/A
             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).
34846.....  Endovascular repair of visceral aorta                C             C             C  N/A
             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]).
34847.....  Endovascular repair of visceral aorta                C             C             C  N/A
             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
             three visceral artery endoprostheses
             (superior mesenteric, celiac and/or
             renal artery[s]).
34848.....  Endovascular repair of visceral aorta                C             C             C  N/A
             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 (superior mesenteric,
             celiac and/or renal artery[s]).
36475.....  Endovenous ablation therapy of                   6.72          5.30          5.30   No
             incompetent vein, extremity, inclusive
             of all imaging guidance and monitoring,
             percutaneous, radiofrequency; first
             vein treated.
36476.....  Endovenous ablation therapy of                   3.38          2.65          2.65   No
             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).
36478.....  Endovenous ablation therapy of                   6.72          5.30          5.30   No
             incompetent vein, extremity, inclusive
             of all imaging guidance and monitoring,
             percutaneous, laser; first vein treated.
36479.....  Endovenous ablation therapy of                   3.38          2.65          2.65   No
             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).
36818.....  Arteriovenous anastomosis, open; by             11.89         13.00         12.39   No
             upper arm cephalic vein transposition.
36819.....  Arteriovenous anastomosis, open; by             13.29         15.00         13.29   No
             upper arm basilic vein transposition.
36820.....  Arteriovenous anastomosis, open; by             14.47         13.99         13.07   No
             forearm vein transposition.
36821.....  Arteriovenous anastomosis, open; direct,        12.11         11.90         11.90   No
             any site (eg, cimino type) (separate
             procedure).

[[Page 67656]]

 
36825.....  Creation of arteriovenous fistula by            14.17         15.93         14.17   No
             other than direct arteriovenous
             anastomosis (separate procedure);
             autogenous graft.
36830.....  Creation of arteriovenous fistula by            12.03         11.90         12.03   No
             other than direct arteriovenous
             anastomosis (separate procedure);
             nonautogenous graft (eg, biological
             collagen, thermoplastic graft).
36831.....  Thrombectomy, open, arteriovenous                8.04         11.00         11.00   Yes
             fistula without revision, autogenous or
             nonautogenous dialysis graft (separate
             procedure).
36832.....  Revision, open, arteriovenous fistula;          10.53         13.50         13.50   Yes
             without thrombectomy, autogenous or
             nonautogenous dialysis graft (separate
             procedure).
36833.....  Revision, open, arteriovenous fistula;          11.98         14.50         14.50   Yes
             with thrombectomy, autogenous or
             nonautogenous dialysis graft (separate
             procedure).
37218.....  Transcatheter placement of intravascular        (\1\)         15.00         15.00   No
             stent(s), intrathoracic common carotid
             artery or innominate artery, open or
             percutaneous antegrade approach,
             including angioplasty, when performed,
             and radiological supervision and
             interpretation.
43180.....  Esophagoscopy, rigid, transoral with            (\1\)          9.03          9.03   No
             diverticulectomy of hypopharynx or
             cervical esophagus (eg, zenker's
             diverticulum), with cricopharyngeal
             myotomy, includes use of telescope or
             operating microscope and repair, when
             performed.
44381.....  Ileoscopy, through stoma; with                  (\1\)          1.48             I   N/A
             transendoscopic balloon dilation.
44384.....  Ileoscopy, through stoma; with placement        (\1\)          3.11             I   N/A
             of endoscopic stent (includes pre- and
             post-dilation and guide wire passage,
             when performed).
44401.....  Colonoscopy through stoma; with ablation        (\1\)          4.44             I   N/A
             of tumor(s), polyp(s), or other
             lesion(s) (includes pre- and post-
             dilation and guide wire passage, when
             performed).
44402.....  Colonoscopy through stoma; with                 (\1\)          4.96             I   N/A
             endoscopic stent placement (including
             pre- and post-dilation and guide wire
             passage, when performed).
44403.....  Colonoscopy through stoma; with                 (\1\)          5.81             I   N/A
             endoscopic mucosal resection.
44404.....  Colonoscopy through stoma; with directed        (\1\)          3.13             I   N/A
             submucosal injection(s), any substance.
44405.....  Colonoscopy through stoma; with                 (\1\)          3.33             I   N/A
             transendoscopic balloon dilation.
44406.....  Colonoscopy through stoma; with                 (\1\)          4.41             I   N/A
             endoscopic ultrasound examination,
             limited to the sigmoid, descending,
             transverse, or ascending colon and
             cecum and adjacent structures.
44407.....  Colonoscopy through stoma; with                 (\1\)          5.06             I   N/A
             transendoscopic ultrasound guided
             intramural 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.
44408.....  Colonoscopy through stoma; with                 (\1\)          4.24             I   N/A
             decompression (for pathologic
             distention) (eg, volvulus, megacolon),
             including placement of decompression
             tube, when performed.
45346.....  Sigmoidoscopy, flexible; with ablation          (\1\)          2.97             I   N/A
             of tumor(s), polyp(s), or other
             lesion(s) (includes pre- and post-
             dilation and guide wire passage, when
             performed).
45347.....  Sigmoidoscopy, flexible; with placement         (\1\)          2.98             I   N/A
             of endoscopic stent (includes pre- and
             post-dilation and guide wire passage,
             when performed).
45349.....  Sigmoidoscopy, flexible; with endoscopic        (\1\)          3.83             I   N/A
             mucosal resection.
45350.....  Sigmoidoscopy, flexible; with band              (\1\)          1.78             I   N/A
             ligation(s) (eg, hemorrhoids).
45388.....  Colonoscopy, flexible; with ablation of         (\1\)          4.98             I   N/A
             tumor(s), polyp(s), or other lesion(s)
             (includes pre- and post-dilation and
             guide wire passage, when performed).
45389.....  Colonoscopy, flexible; with endoscopic          (\1\)          5.50             I   N/A
             stent placement (includes pre- and post-
             dilation and guide wire passage, when
             performed).
45390.....  Colonoscopy, flexible; with endoscopic          (\1\)          6.35             I   N/A
             mucosal resection.
45393.....  Colonoscopy, flexible; with                     (\1\)          4.78             I   N/A
             decompression (for pathologic
             distention) (eg, volvulus, megacolon),
             including placement of decompression
             tube, when performed.
45398.....  Colonoscopy, flexible; with band                (\1\)          4.30   ............  N/A
             ligation(s) (eg, hemorrhoids).
45399.....  Unlisted procedure, colon...............        (\1\)          None             I   N/A
46601.....  Anoscopy; diagnostic, with high-                (\1\)          1.60             I   N/A
             resolution magnification (hra) (eg,
             colposcope, operating microscope) and
             chemical agent enhancement, including
             collection of specimen(s) by brushing
             or washing, when performed.
46607.....  Anoscopy; with high-resolution                  (\1\)          2.20             I   N/A
             magnification (hra) (eg, colposcope,
             operating microscope) and chemical
             agent enhancement, with biopsy, single
             or multiple.
47383.....  Ablation, 1 or more liver tumor(s),             (\1\)          9.13          9.13   No
             percutaneous, cryoablation.

[[Page 67657]]

 
52441.....  Cystourethroscopy, with insertion of            (\1\)          4.50          4.50   No
             permanent adjustable transprostatic
             implant; single implant.
52442.....  Cystourethroscopy, with insertion of            (\1\)          1.20          1.20   No
             permanent adjustable transprostatic
             implant; each additional permanent
             adjustable transprostatic implant (list
             separately in addition to code for
             primary procedure).
55840.....  Prostatectomy, retropubic radical, with         24.63         21.36         21.36   No
             or without nerve sparing;.
55842.....  Prostatectomy, retropubic radical, with         26.49         24.16         21.36   No
             or without nerve sparing; with lymph
             node biopsy(s) (limited pelvic
             lymphadenectomy).
55845.....  Prostatectomy, retropubic radical, with         30.67         29.07         25.18   No
             or without nerve sparing; with
             bilateral pelvic lymphadenectomy,
             including external iliac, hypogastric,
             and obturator nodes.
58541.....  Laparoscopy, surgical, supracervical            14.70         12.29         12.29   No
             hysterectomy, for uterus 250 g or less;.
58542.....  Laparoscopy, surgical, supracervical            16.56         14.16         14.16   No
             hysterectomy, for uterus 250 g or less;
             with removal of tube(s) and/or ovary(s).
58543.....  Laparoscopy, surgical, supracervical            16.87         14.39         14.39   No
             hysterectomy, for uterus greater than
             250 g;.
58544.....  Laparoscopy, surgical, supracervical            18.37         15.60         15.60   No
             hysterectomy, for uterus greater than
             250 g; with removal of tube(s) and/or
             ovary(s).
58570.....  Laparoscopy, surgical, with total               15.88         13.36         13.36   No
             hysterectomy, for uterus 250 g or less;.
58571.....  Laparoscopy, surgical, with total               17.69         15.00         15.00   No
             hysterectomy, for uterus 250 g or less;
             with removal of tube(s) and/or ovary(s).
58572.....  Laparoscopy, surgical, with total               20.09         17.71         17.71   No
             hysterectomy, for uterus greater than
             250 g;.
58573.....  Laparoscopy, surgical, with total               23.11         20.79         20.79   No
             hysterectomy, for uterus greater than
             250 g; with removal of tube(s) and/or
             ovary(s).
62284.....  Injection procedure for myelography and/         1.54          1.54          1.54   No
             or computed tomography, lumbar (other
             than c1-c2 and posterior fossa).
62302.....  Myelography via lumbar injection,               (\1\)          2.29          2.29   No
             including radiological supervision and
             interpretation; cervical.
62303.....  Myelography via lumbar injection,               (\1\)          2.29          2.29   No
             including radiological supervision and
             interpretation; thoracic.
62304.....  Myelography via lumbar injection,               (\1\)          2.25          2.25   No
             including radiological supervision and
             interpretation; lumbosacral.
62305.....  Myelography via lumbar injection,               (\1\)          2.35          2.35   No
             including radiological supervision and
             interpretation; 2 or more regions (eg,
             lumbar/thoracic, cervical/thoracic,
             lumbar/cervical, lumbar/thoracic/
             cervical).
64486.....  Transversus abdominis plane (tap) block         (\1\)          1.27          1.27   No
             (abdominal plane block, rectus sheath
             block) unilateral; by injection(s)
             (includes imaging guidance, when
             performed).
64487.....  Transversus abdominis plane (tap) block         (\1\)          1.48          1.48   No
             (abdominal plane block, rectus sheath
             block) unilateral; by continuous
             infusion(s) (includes imaging guidance,
             when performed).
64488.....  Transversus abdominis plane (tap) block         (\1\)          1.60          1.60   No
             (abdominal plane block, rectus sheath
             block) bilateral; by injections
             (includes imaging guidance, when
             performed).
64489.....  Transversus abdominis plane (tap) block         (\1\)          1.80          1.80   No
             (abdominal plane block, rectus sheath
             block) bilateral; by continuous
             infusions (includes imaging guidance,
             when performed).
64561.....  Percutaneous implantation of                     7.15          5.44          5.44   No
             neurostimulator electrode array; sacral
             nerve (transforaminal placement)
             including image guidance, if performed.
66179.....  Aqueous shunt to extraocular equatorial         (\1\)         14.00         14.00   No
             plate reservoir, external approach;
             without graft.
66180.....  Aqueous shunt to extraocular equatorial         16.30         15.00         15.00   No
             plate reservoir, external approach;
             with graft.
66184.....  Revision of aqueous shunt to extraocular        (\1\)          9.58          9.58   No
             equatorial plate reservoir; without
             graft.
66185.....  Revision of aqueous shunt to extraocular         9.58         10.58         10.58   No
             equatorial plate reservoir; with graft.
67036.....  Vitrectomy, mechanical, pars plana              13.32         12.13         12.13   No
             approach;.
67039.....  Vitrectomy, mechanical, pars plana              16.74         13.20         13.20   No
             approach; with focal endolaser
             photocoagulation.
67040.....  Vitrectomy, mechanical, pars plana              19.61         14.50         14.50   No
             approach; with endolaser panretinal
             photocoagulation.
67041.....  Vitrectomy, mechanical, pars plana              19.25         16.33         16.33   No
             approach; with removal of preretinal
             cellular membrane (eg, macular pucker).

[[Page 67658]]

 
67042.....  Vitrectomy, mechanical, pars plana              22.38         16.33         16.33   No
             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).
67043.....  Vitrectomy, mechanical, pars plana              23.24         17.40         17.40   No
             approach; with removal of subretinal
             membrane (eg, choroidal
             neovascularization), includes, if
             performed, intraocular tamponade (ie,
             air, gas or silicone oil) and laser
             photocoagulation.
67255.....  Scleral reinforcement (separate                 10.17         10.17          8.38   No
             procedure); with graft.
70486.....  Computed tomography, maxillofacial area;         1.14          0.85          0.85   No
             without contrast material.
70487.....  Computed tomography, maxillofacial area;         1.30          1.17          1.13   No
             with contrast material(s).
70488.....  Computed tomography, maxillofacial area;         1.42          1.30          1.27   No
             without contrast material, followed by
             contrast material(s) and further
             sections.
70496.....  Computed tomographic angiography, head,          1.75          1.75          1.75   No
             with contrast material(s), including
             noncontrast images, if performed, and
             image postprocessing.
70498.....  Computed tomographic angiography, neck,          1.75          1.75          1.75   No
             with contrast material(s), including
             noncontrast images, if performed, and
             image postprocessing.
71275.....  Computed tomographic angiography, chest          1.92          1.82          1.82   No
             (noncoronary), with contrast
             material(s), including noncontrast
             images, if performed, and image
             postprocessing.
72191.....  Computed tomographic angiography,                1.81          1.81          1.81   No
             pelvis, with contrast material(s),
             including noncontrast images, if
             performed, and image postprocessing.
72240.....  Myelography, cervical, radiological              0.91          0.91          0.91   No
             supervision and interpretation.
72255.....  Myelography, thoracic, radiological              0.91          0.91          0.91   No
             supervision and interpretation.
72265.....  Myelography, lumbosacral, radiological           0.83          0.83          0.83   No
             supervision and interpretation.
72270.....  Myelography, 2 or more regions (eg,              1.33          1.33          1.33   No
             lumbar/thoracic, cervical/thoracic,
             lumbar/cervical, lumbar/thoracic/
             cervical), radiological supervision and
             interpretation.
74174.....  Computed tomographic angiography,                2.20          2.20          2.20   No
             abdomen and pelvis, with contrast
             material(s), including noncontrast
             images, if performed, and image
             postprocessing.
74175.....  Computed tomographic angiography,                1.90          1.82          1.82   No
             abdomen, with contrast material(s),
             including noncontrast images, if
             performed, and image postprocessing.
74230.....  Swallowing function, with                        0.53          0.53          0.53   No
             cineradiography/videoradiography.
76641.....  Ultrasound, breast, unilateral, real            (\1\)          0.73          0.73   No
             time with image documentation,
             including axilla when performed;
             complete.
76642.....  Ultrasound, breast, unilateral, real            (\1\)          0.68          0.68   No
             time with image documentation,
             including axilla when performed;
             limited.
76700.....  Ultrasound, abdominal, real time with            0.81          0.81          0.81   No
             image documentation; complete.
76705.....  Ultrasound, abdominal, real time with            0.59          0.59          0.59   No
             image documentation; limited (eg,
             single organ, quadrant, follow-up).
76770.....  Ultrasound, retroperitoneal (eg, renal,          0.74          0.74          0.74   No
             aorta, nodes), real time with image
             documentation; complete.
76775.....  Ultrasound, retroperitoneal (eg, renal,          0.58          0.58          0.58   No
             aorta, nodes), real time with image
             documentation; limited.
76856.....  Ultrasound, pelvic (nonobstetric), real          0.69          0.69          0.69   No
             time with image documentation; complete.
76857.....  Ultrasound, pelvic (nonobstetric), real          0.38          0.50          0.50   No
             time with image documentation; limited
             or follow-up (eg, for follicles).
76930.....  Ultrasonic guidance for                          0.67          0.67          0.67   No
             pericardiocentesis, imaging supervision
             and interpretation.
76932.....  Ultrasonic guidance for endomyocardial               C         0.85          0.85   No
             biopsy, imaging supervision and
             interpretation.
76942.....  Ultrasonic guidance for needle placement         0.67          0.67          0.67   No
             (eg, biopsy, aspiration, injection,
             localization device), imaging
             supervision and interpretation.
76948.....  Ultrasonic guidance for aspiration of            0.38          0.92          0.92   No
             ova, imaging supervision and
             interpretation.
77061.....  Digital breast tomosynthesis; unilateral        (\1\)          0.70             I   N/A
77062.....  Digital breast tomosynthesis; bilateral.        (\1\)          0.90             I   N/A
77063.....  Screening digital breast tomosynthesis,         (\1\)          0.60          0.60   No
             bilateral (list separately in addition
             to code for primary procedure).
77080.....  Dual-energy x-ray absorptiometry (dxa),          0.20          0.20          0.20   No
             bone density study, 1 or more sites;
             axial skeleton (eg, hips, pelvis,
             spine).
77085.....  Dual-energy x-ray absorptiometry (dxa),         (\1\)          0.30          0.30   No
             bone density study, 1 or more sites;
             axial skeleton (eg, hips, pelvis,
             spine), including vertebral fracture
             assessment.

[[Page 67659]]

 
77086.....  Vertebral fracture assessment via dual-         (\1\)          0.17          0.17   No
             energy x-ray absorptiometry (dxa).
77300.....  Basic radiation dosimetry calculation,           0.62          0.62          0.62   No
             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.
77306.....  Teletherapy isodose plan; simple (1 or 2        (\1\)          1.40          1.40   No
             unmodified ports directed to a single
             area of interest), includes basic
             dosimetry calculation(s).
77307.....  Teletherapy isodose plan; complex               (\1\)          2.90          2.90   No
             (multiple treatment areas, tangential
             ports, the use of wedges, blocking,
             rotational beam, or special beam
             considerations), includes basic
             dosimetry calculation(s).
77316.....  Brachytherapy isodose plan; simple              (\1\)          1.50          1.40   No
             (calculation[s] made from 1 to 4
             sources, or remote afterloading
             brachytherapy, 1 channel), includes
             basic dosimetry calculation(s).
77317.....  Brachytherapy isodose plan; intermediate        (\1\)          1.83          1.83   No
             (calculation[s] made from 5 to 10
             sources, or remote afterloading
             brachytherapy, 2-12 channels), includes
             basic dosimetry calculation(s).
77318.....  Brachytherapy isodose plan; complex             (\1\)          2.90          2.90   No
             (calculation[s] made from over 10
             sources, or remote afterloading
             brachytherapy, over 12 channels),
             includes basic dosimetry calculation(s).
77385.....  Intensity modulated radiation treatment         (\1\)   ............            I   N/A
             delivery (imrt), includes guidance and
             tracking, when performed; simple.
77386.....  Intensity modulated radiation treatment         (\1\)   ............            I   N/A
             delivery (imrt), includes guidance and
             tracking, when performed; complex.
77387.....  Guidance for localization of target             (\1\)          0.58             I   N/A
             volume for delivery of radiation
             treatment delivery, includes
             intrafraction tracking, when performed.
77402.....  Radiation treatment delivery, >1 mev;            0.00   ............            I   N/A
             simple.
77407.....  Radiation treatment delivery, >1 mev;            0.00   ............            I   N/A
             intermediate.
77412.....  Radiation treatment delivery, >1 mev;            0.00   ............            I   N/A
             complex.
88341.....  Immunohistochemistry or                         (\1\)          0.65          0.42   No
             immunocytochemistry, per specimen; each
             additional single antibody stain
             procedure (list separately in addition
             to code for primary procedure).
88342.....  Immunohistochemistry or                             I          0.70          0.70   No
             immunocytochemistry, per specimen;
             initial single antibody stain procedure.
88344.....  Immunohistochemistry or                         (\1\)          0.77          0.77   No
             immunocytochemistry, per specimen; each
             multiplex antibody stain procedure.
88356.....  Morphometric analysis; nerve............         3.02          2.80          2.80   No
88364.....  In situ hybridization (eg, fish), per           (\1\)          0.88          0.53   No
             specimen; each additional single probe
             stain procedure (list separately in
             addition to code for primary procedure).
88365.....  In situ hybridization (eg, fish), per            1.20          0.88          0.88   No
             specimen; initial single probe stain
             procedure.
88366.....  In situ hybridization (eg, fish), per           (\1\)          1.24          1.24   No
             specimen; each multiplex probe stain
             procedure.
88367.....  Morphometric analysis, in situ                   1.30          0.86          0.73   No
             hybridization (quantitative or semi-
             quantitative), using computer-assisted
             technology, per specimen; initial
             single probe stain procedure.
88368.....  Morphometric analysis, in situ                   1.40          0.88          0.88   No
             hybridization (quantitative or semi-
             quantitative), manual, per specimen;
             initial single probe stain procedure.
88369.....  Morphometric analysis, in situ                  (\1\)          0.88          0.53   No
             hybridization (quantitative or semi-
             quantitative), manual, per specimen;
             each additional single probe stain
             procedure (list separately in addition
             to code for primary procedure).
88373.....  Morphometric analysis, in situ                  (\1\)          0.86          0.43   No
             hybridization (quantitative or semi-
             quantitative), using computer-assisted
             technology, per specimen; each
             additional single probe stain procedure
             (list separately in addition to code
             for primary procedure).
88374.....  Morphometric analysis, in situ                  (\1\)          1.04          0.93   No
             hybridization (quantitative or semi-
             quantitative), using computer-assisted
             technology, per specimen; each
             multiplex probe stain procedure.
88377.....  Morphometric analysis, in situ                  (\1\)          1.40          1.40   No
             hybridization (quantitative or semi-
             quantitative), manual, per specimen;
             each multiplex probe stain procedure.
88380.....  Microdissection (ie, sample preparation          1.56          1.14          1.14   No
             of microscopically identified target);
             laser capture.
88381.....  Microdissection (ie, sample preparation          1.18          0.53          0.53   No
             of microscopically identified target);
             manual.
91200.....  Liver elastography, mechanically induced        (\1\)          0.30          0.30   No
             shear wave (eg, vibration), without
             imaging, with interpretation and report.

[[Page 67660]]

 
92145.....  Corneal hysteresis determination, by air        (\1\)          0.17          0.17   No
             impulse stimulation, unilateral or
             bilateral, with interpretation and
             report.
92540.....  Basic vestibular evaluation, includes            1.50          1.50          1.50   No
             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.
92541.....  Spontaneous nystagmus test, including            0.40          0.40          0.40   No
             gaze and fixation nystagmus, with
             recording.
92542.....  Positional nystagmus test, minimum of 4          0.33          0.48          0.48   No
             positions, with recording.
92543.....  Caloric vestibular test, each irrigation         0.10          0.35          0.10   No
             (binaural, bithermal stimulation
             constitutes 4 tests), with recording.
92544.....  Optokinetic nystagmus test,                      0.26          0.27          0.27   No
             bidirectional, foveal or peripheral
             stimulation, with recording.
92545.....  Oscillating tracking test, with                  0.23          0.27          0.27   No
             recording.
93260.....  Programming device evaluation (in               (\1\)          0.85          0.85   No
             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.
93261.....  Interrogation device evaluation (in             (\1\)          0.74          0.74   No
             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.
93282.....  Programming device evaluation (in                0.85          0.85          0.85   No
             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.
93283.....  Programming device evaluation (in                1.15          1.15          1.15   No
             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; dual lead
             transvenous implantable defibrillator
             system.
93284.....  Programming device evaluation (in                1.25          1.25          1.25   No
             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.
93287.....  Peri-procedural device evaluation (in            0.45          0.45          0.45   No
             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.
93289.....  Interrogation device evaluation (in              0.92          0.92          0.92   No
             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.
93312.....  Echocardiography, transesophageal, real-         2.20          3.18          2.55   No
             time with image documentation (2d)
             (with or without m-mode recording);
             including probe placement, image
             acquisition, interpretation and report.
93313.....  Echocardiography, transesophageal, real-         0.95          1.00          0.51   No
             time with image documentation (2d)
             (with or without m-mode recording);
             placement of transesophageal probe only.
93314.....  Echocardiography, transesophageal, real-         1.25          2.80          2.10   Yes
             time with image documentation (2d)
             (with or without m-mode recording);
             image acquisition, interpretation and
             report only.
93315.....  Transesophageal echocardiography for                 C         3.29          2.94   No
             congenital cardiac anomalies; including
             probe placement, image acquisition,
             interpretation and report.
93316.....  Transesophageal echocardiography for             0.95          1.50          0.85   No
             congenital cardiac anomalies; placement
             of transesophageal probe only.
93317.....  Transesophageal echocardiography for                 C         3.00          2.09   Yes
             congenital cardiac anomalies; image
             acquisition, interpretation and report
             only.

[[Page 67661]]

 
93318.....  Echocardiography, transesophageal (tee)              C         2.40          2.40   No
             for monitoring purposes, including
             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.
93320.....  Doppler echocardiography, pulsed wave            0.38          0.38          0.38   No
             and/or continuous wave with spectral
             display (list separately in addition to
             codes for echocardiographic imaging);
             complete.
93321.....  Doppler echocardiography, pulsed wave            0.15          0.15          0.15   No
             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).
93325.....  Doppler echocardiography color flow              0.07          0.07          0.07   No
             velocity mapping (list separately in
             addition to codes for echocardiography).
93355.....  Echocardiography, transesophageal (tee)         (\1\)          4.66          4.66   No
             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 occlusion/closure,
             ventricular septal defect closure)
             (peri- and intra-procedural), real-time
             image acquisition 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.
93644.....  Electrophysiologic evaluation of                (\1\)          3.65          3.29   No
             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).
93880.....  Duplex scan of extracranial arteries;            0.60          0.80          0.80   No
             complete bilateral study.
93882.....  Duplex scan of extracranial arteries;            0.40          0.50          0.50   No
             unilateral or limited study.
93886.....  Transcranial doppler study of the                0.94          1.00          0.91   No
             intracranial arteries; complete study.
93888.....  Transcranial doppler study of the                0.62          0.70          0.50   No
             intracranial arteries; limited study.
93895.....  Quantitative carotid intima media               (\1\)          0.55             N   No
             thickness and carotid atheroma
             evaluation, bilateral.
93925.....  Duplex scan of lower extremity arteries          0.80          0.80          0.80   No
             or arterial bypass grafts; complete
             bilateral study.
93926.....  Duplex scan of lower extremity arteries          0.50          0.60          0.50   No
             or arterial bypass grafts; unilateral
             or limited study.
93930.....  Duplex scan of upper extremity arteries          0.46          0.80          0.80   No
             or arterial bypass grafts; complete
             bilateral study.
93931.....  Duplex scan of upper extremity arteries          0.31          0.50          0.50   No
             or arterial bypass grafts; unilateral
             or limited study.
93970.....  Duplex scan of extremity veins including         0.70          0.70          0.70   No
             responses to compression and other
             maneuvers; complete bilateral study.
93971.....  Duplex scan of extremity veins including         0.45          0.45          0.45   No
             responses to compression and other
             maneuvers; unilateral or limited study.
93975.....  Duplex scan of arterial inflow and               1.80          1.30          1.16   No
             venous outflow of abdominal, pelvic,
             scrotal contents and/or retroperitoneal
             organs; complete study.
93976.....  Duplex scan of arterial inflow and               1.21          1.00          0.80   No
             venous outflow of abdominal, pelvic,
             scrotal contents and/or retroperitoneal
             organs; limited study.
93978.....  Duplex scan of aorta, inferior vena              0.65          0.97          0.80   No
             cava, iliac vasculature, or bypass
             grafts; complete study.
93979.....  Duplex scan of aorta, inferior vena              0.44          0.70          0.50   No
             cava, iliac vasculature, or bypass
             grafts; unilateral or limited study.
93990.....  Duplex scan of hemodialysis access               0.25          0.60          0.50   No
             (including arterial inflow, body of
             access and venous outflow).
95971.....  Electronic analysis of implanted                 0.78          0.78          0.78   No
             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 spinal
             cord, or peripheral (ie, peripheral
             nerve, sacral nerve, neuromuscular)
             neurostimulator pulse generator/
             transmitter, with intraoperative or
             subsequent programming.

[[Page 67662]]

 
95972.....  Electronic analysis of implanted                 1.50          0.90          0.80   No
             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, sacral nerve,
             neuromuscular) (except cranial nerve)
             neurostimulator pulse generator/
             transmitter, with intraoperative or
             subsequent programming, up to 1 hour.
95973.....  Electronic analysis of implanted                 0.92            NA          0.49   No
             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, sacral 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).
97605.....  Negative pressure wound therapy (eg,             0.55          0.55          0.55   No
             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.
97606.....  Negative pressure wound therapy (eg,             0.60          0.60          0.60   No
             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.
97607.....  Negative pressure wound therapy, (eg,           (\1\)          0.41              C  ................
             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.
97608.....  Negative pressure wound therapy, (eg,           (\1\)          0.46              C  Yes
             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.
97610.....  Low frequency, non-contact, non-thermal              C         0.35          0.35   No
             ultrasound, including topical
             application(s), when performed, wound
             assessment, and instruction(s) for
             ongoing care, per day.
99183.....  Physician or other qualified health care         2.34          2.11          2.11   No
             professional attendance and supervision
             of hyperbaric oxygen therapy, per
             session.
99184.....  Initiation of selective head or total           (\1\)          4.50          4.50   No
             body hypothermia in the critically ill
             neonate, includes appropriate patient
             selection 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.
99188.....  Application of topical fluoride varnish         (\1\)          0.20             N   N/A
             by a physician or other qualified
             health care professional.
99487.....  Complex chronic care management                  1.00          1.00             B   N/A
             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 exacerbation/
             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
             time directed by a physician or other
             qualified health care professional, per
             calendar month.
99497.....  Advance care planning including the             (\1\)          1.50             I   N/A
             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.

[[Page 67663]]

 
99498.....  Advance care planning including the             (\1\)          1.40             I   N/A
             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).
G0279.....  Diagnostic digital breast tomosynthesis,        (\1\)           N/A          0.60   N/A
             unilateral or bilateral (list
             separately in addition to G0204 or
             G0206).
----------------------------------------------------------------------------------------------------------------
\1\ New.

i. Code Specific Issues
(1) Internal Fixation of Rib Fracture (CPT Codes 21811, 21812 and 
21813)
    For CY 2015, the CPT Editorial Panel deleted 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 fracture. 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 accurately valuing codes as 90-day global services, we 
believe that the valuation of these codes should be as 0-day global 
services. In addition, we believe this is particularly appropriate for 
these codes because the number of RUC-recommended inpatient and 
outpatient visits included in the 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 internal fixation. The seven visits included in the postservice 
time for this code seem high since the vignette does not describe a 
very ill patient. The vignettes for CPT codes 21812 and 21813 describe 
patients experiencing significant rib fractures in car accidents that 
require internal fixation. We believe 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 other practitioners would furnish care in the post-
surgery period, we believe the ten and thirteen postservice visits 
included in CPT codes 21812 and 21813 would likely not occur. By 
valuing these 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 after the day of the 
procedure.
    To value these services as 0-day global codes, 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 for 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 and Augmentation (CPT Codes 22510, 
22511, 22512, 22513, 22514 and 22515)
    For CY 2015, the CPT Editorial Panel replaced the eight existing 
percutaneous vertebroplasty with six new codes, CPT codes 22510-22515, 
which include the percutaneous vertebroplasty and the image guidance 
together. 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 the survey, the RUC 
established its recommended work value for CPT code 22511 by 
crosswalking this 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 included when 
performed), 1 vertebral body, unilateral or bilateral injection; 
thoracic) and 22521 (Percutaneous vertebroplasty (bone biopsy included 
when performed), 1 vertebral body, unilateral or bilateral injection; 
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 family 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 those 
services for which Medicare utilization increased by at least 100 
percent from 2006 to 2011. CPT code 31620 is an add-on code to CPT code 
31629 (Bronchoscopy, rigid or flexible, including fluoroscopic 
guidance, when performed; with transbronchial needle aspiration 
biopsy(s), trachea, main stem and/or lobar bronchus(i)).
    Medicare data show that 82 percent of the time when EBUS is billed 
it is billed with CPT code 31629. Given this relationship, we believe 
that 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, 
based 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 believe the EBUS code 
descriptor accurately describes the service nor is it possible to 
accurately value this service when the descriptor is inaccurate. 
Therefore, for CY 2015 we are maintaining the CY 2014 work RVU for

[[Page 67664]]

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. Specifically, the 
services were originally valued when they were primarily provided to 
premature neonates; but the services are now typically used in treating 
adults with severe influenza, pneumonia, and respiratory distress 
syndrome. For CY 2015, CPT codes 33960 and 33961 were deleted and 
replaced with 25 new codes to describe this treatment. We are assigning 
the RUC-recommended 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) insertion for 
individuals up to 5 years of age. The 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 from the younger 
patient. The fact that the RUC-recommended intraservice time is 
identical for both codes supports our view 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 reasons discussed above, we are 
establishing 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, CPT code 
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)) and CPT code 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)), to reflect the greater work of 
the open procedure codes, CPT codes 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) and 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). To measure the difference in work between 
these two sets of codes we applied the 0.96 RVU differential 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 catheterization or cannulation 
for sampling, monitoring or transfusion (separate procedure); cutdown) 
codes. This measure allows us to establish the difference in work 
between the sets of codes based upon the difference in intensity. 
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 survey, 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 family, these codes should be valued based upon the 
25th percentile values of the survey because those values best describe 
the work involved in these procedures and results in the appropriate 
relativity amongst the codes in the family. Therefore, for CY 2015 we 
are assigning an interim final 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 differential between the percutaneous arterial and open 
arterial CPT codes more appropriately reflects the work involved in 
these services. Accordingly we are establishing a CY 2015 interim final 
work RVU of 4.47 for CPT codes 33959 and 33962.
    After researching comparable codes, we believe the RUC-recommended 
work RVUs of 6.00 and 6.38 for CPT codes 33969 and 33984, respectively, 
overstates the work involved in the procedures. For the same reasons 
and following the same valuation methodology utilized above, we added 
the differential between the percutaneous arterial and arterial cutdown 
codes, 0.96 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)/extracorporeal life support 
(ECLS) provided by physician; removal of peripheral (arterial and/or 
venous) cannula(e), open, 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 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). 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 (FEVAR) Endograft Planning (CPT 
Code 34839)
    For CY 2015, CPT code 34839 was created to report the planning that 
occurs 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 prefer that planning be bundled 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 indicator of B (Bundled Code) 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 
misvalued due to rank order anomalies, including CPT codes 36818-36821 
and CPT codes 36825-36830. The RUC recommendations that we received

[[Page 67665]]

in response also included CPT codes 36831-36833. We are assigning the 
RUC-recommended work RVUs as CY 2015 interim final values for CPT codes 
36821, 36831, 36832 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 approximately 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, which reflects a 4.2 percent 
increase from the current value based upon the increase in total time.
    For CPT code 36819, the RUC-recommended intraservice 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 RVU. 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 postservice 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 reduction was accounted for in the 
RUC-recommended work RVU. To account 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 intraservice and total 
times are only minimally different than the current times. However, 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. For CPT code 36830, the RUC-recommended intraservice 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 without 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 values 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 through 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, G6019, 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 codes as potentially 
misvalued and the affected specialty society's contention that this 
code set did not allow for accurate reporting of services based upon 
the current practice. The RUC subsequently provided recommendations to 
CMS for valuing these services. In comments on the proposed rule, 
stakeholders noted our proposal to begin including proposed values for 
new, revised and potentially misvalued codes in the proposed rule. 
Commenters suggested that, rather than implementing this new process in 
CY 2016, we should implement it immediately and thus defer the 
valuation of the new GI code set until CY 2016. They indicated that the 
opportunity to comment prior to implementation of the new values was 
important for these codes, many of which have high utilization. In 
addition, in this final rule with comment period we discuss the need to 
modify how moderate sedation 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 conjunction with 
any changes in reporting and valuation of moderate sedation.
    We agree with the commenters. In light of the substantial nature of 
this code revision and its relationship to the policies on moderate 
sedation, we are delaying revaluation of these codes until CY 2016 when 
we will be able to include proposals in the proposed rule for their 
valuation, along with consideration of policies for moderate sedation. 
Accordingly for CY 2015, we are maintaining the inputs for the lower 
gastrointestinal endoscopy codes at the CY 2014 levels. (Note: Due to 
budget neutrality adjustments and other system-wide changes, the 
payment rates may change.) Since the code set is changing for CY 2015, 
including 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 G-codes that we are creating and the CY 2014 
CPT codes that they are replacing.

                 Table 26--Lower Gastrointestinal Endoscopy 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.

[[Page 67666]]

 
45345...................  G6023...................  Sigmoidoscopy, flexible; with transenoscopic stent placement
                                                     (includes predilation).
45383...................  G6024...................  Colonoscopy, flexible, proximal to splenic flexure; 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 magnification and
                                                     chemical agent enhancement); diagnostic, including
                                                     collection of specimen(s) by brushing or washing when
                                                     performed.
0227T...................  G6028...................  Anoscopy, high resolution (HRA) (with magnification and
                                                     chemical agent enhancement); with biopsy(ies).
----------------------------------------------------------------------------------------------------------------
\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.

(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 code 55842, we are crosswalking it to CPT code 
55840 (Prostatectomy, retropubic radical, with or without 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 since the last valuation, based upon a 20 percent decrease 
in intraservice time and the 29 percent decrease in total time.
(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 recommended 
work RVUs for the aqueous shunt family for CY 2015. We are establishing 
the RUC-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. However, we believe maintaining 
this value would be inconsistent with the RUC-recommended decreases 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 crosswalking this 
code to the equivalent code in the CT for the head or brain, CPT code 
70450 (Computed tomography, 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 contrast 
material(s), to the CPT code 70460, which is the equivalent code in the 
head or brain family and CPT code 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.
(11) Breast Ultrasound (CPT Codes 76641 and 76642)
    For CY 2015, the CPT Editorial Panel replaced CPT code 76645 
(Ultrasound, breast(s) (unilateral or bilateral), real time with image 
documentation) with two codes, CPT codes 76641 (Ultrasound, breast, 
unilateral, real time with image documentation, including axilla when 
performed; complete) and 76642 (Ultrasound, breast, unilateral, real 
time with image documentation, including axilla when performed; 
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 difference 
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 unilateral ones. To appropriately adjust 
payment when bilateral procedures are furnished under the PFS, payments 
are adjusted to 150 percent of the unilateral payment when a service 
has a bilateral 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 potentially misvalued and the 
affected specialty society's contention that the provision of radiation 
therapy could 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 of 
Medicare payment for radiation therapy centers. They noted our proposal 
to begin including proposals to value new, revised and potentially 
misvalued codes in the proposed rule, and suggested that these code 
valuations should be delayed to CY 2016 so that they could be addressed 
under this new process. This would provide affected

[[Page 67667]]

stakeholders the opportunity to comment prior to the valuations being 
effective. 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 substantial nature of 
this code revision, we are delaying revaluation 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 work to be done to assure the new valuations for 
these codes accurately reflect the coding changes. Accordingly 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 maintaining the inputs for radiation therapy 
codes at the CY 2014 levels. (Note: Due to budget neutrality 
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 are 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 applicable to the CY 2014 CPT codes will apply to the 
replacement G-codes. The new and revised CY 2015 CPT codes that will 
not be recognized by Medicare for CY 2015 are denoted 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.
    Additionally, we would like to note that changes to the prefatory 
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 superficial radiation therapy. However, the 
RUC did not review superficial radiation therapy procedures, and 
therefore, 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 prohibits them from billing 
for codes that were previously frequently billed in addition to this 
code and as a result there will be a significant reduction in their 
payments.'' We are interested in information on whether the new code 
set combined with modifications in prefatory text allows for 
appropriate reporting of the services associated with superficial 
radiation and whether the payment continues to reflect the relative 
resources required to furnish superficial radiation therapy services.

                         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
                                                     positional tracking, gating, 3D surface tracking), each
                                                     fraction of treatment.
----------------------------------------------------------------------------------------------------------------


[[Page 67668]]

(13) 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 (Digital breast 
tomosynthesis; unilateral), 77062 (Digital breast tomosynthesis; 
bilateral) and 77063 (Screening digital breast tomosynthesis, bilateral 
(List separately in addition to code for primary procedure) and we 
received RUC recommendations for these codes. Currently, these services 
are reported to Medicare using G0202, G0204, and G0206, which describe 
the equivalent procedures using any digital technology (2-D or 3-D). In 
addition, film mammography is reported to Medicare using CPT codes 
77055, 77056 and 77057).
---------------------------------------------------------------------------

    \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.
---------------------------------------------------------------------------

    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 digital mammography services under Medicare with 
the CPT codes, to value the CPT codes for CY 2015 based upon the 
current G-code values, and to include the CPT codes on the potentially 
misvalued code list since the resources involved in furnishing these 
services had 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 finalizing a modified proposal. For a discussion of 
our proposal, a summary 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 value 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.
    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 misvalued code list, which currently 
includes tomosynthesis as well as 2-D mammography. Accordingly, we will 
wait to value the new diagnostic mammography tomosynthesis codes until 
we have received recommendations from the RUC for all mammography 
services. In the interim, we are assigning a PFS indicator of ``I'' to 
77061 and 77062. Those furnishing diagnostic mammography using 
tomosynthesis will continue to report G0204 and G0206 as appropriate. 
In addition, we are creating a new code, G-2079 (Diagnostic digital 
breast tomosynthesis, unilateral or bilateral (List separately in 
addition to G0204 or G0206)) as an add-on code that should be reported 
in addition to the relevant 2-D diagnostic mammography G-code to 
recognize the additional resources involved in furnishing diagnostic 
breast tomosynthesis. We will assign it the same inputs as CPT code 
77063 because we believe it describes a similar service.
(14) Isodose Calculation 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 
brachytherapy isodose planning. We are establishing the RUC-recommended 
work RVUs for CY 2015 for all of the codes in this family except CPT 
code 77316. We disagree with the RUC-recommended crosswalk 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 codes 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 RVU of 1.40 for CPT code 77316.
(15) Immunohistochemistry (CPT codes 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 valid 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 creating incentives for overutilization. For CY 2015, 
the CPT coding was revised with the creation of two new CPT codes, 
88341 and 88344, the revision of CPT code 88342 and the deletion of CPT 
code 88343. We believe 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 codes for CY 
2015. We are 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 percent of the 
base code. For example, the RUC-recommended work RVU for CPT code 88334 
(Pathology consultation during surgery; cytologic examination (for 
example, touch prep, squash prep), each additional 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 (for example, touch prep, squash prep), 
initial site). Similarly, the RUC-recommended work RVU for CPT code 
88177 (Cytopathology, evaluation of fine needle aspirate; immediate 
cytohistologic study to determine adequacy for diagnosis, each separate 
additional evaluation episode, 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 
aspirate; immediate cytohistologic study to determine adequacy for 
diagnosis, first evaluation episode, each site). We believe that the 
relative resources involved in furnishing an add-on service in this 
family would be reflected appropriately using the same 60 percent 
metric. 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 hybridization procedures, CPT codes 88365, 
88367 and 88368, were revised to specify ``each separately identifiable 
probe per block;'' three new add-on codes (CPT codes 88364, 88373, 
88369) were created to specify ``each additional

[[Page 67669]]

separately identifiable probe per slide;'' and three new codes were 
created to specify ``each multiplex probe stain procedure.'' We are 
establishing the RUC-recommended work RVUs as interim final for CY 2015 
for CPT codes 88365, 88366, 88368, and 88377.
    CPT code 88367 is the computer assisted version 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 intraservice time. CPT code 88367 only has 25 minutes of 
intraservice time and we do not believe that the RUC recommended work 
RVU of 0.86 adequately reflects that change in time. We believe 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 assisted version of CPT 
code 88377 but with a drop in intraservice time from 45 minutes to 30 
minutes. We believe applying this ratio to the work RUV of 88377 more 
accurately reflects the work. Therefore, we are assigning an interim 
final work RVU to CPT code 88374 of 0.93.
    As discussed in the previous section, some of the add-on codes in 
this family had RUC-recommended 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 the 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 
RVU 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 CMS-Other Source--Utilization over 250,000 screen, CPT 
revised the parentheticals for this code for CY 2015. We received RUC 
recommendations for CY 2015 for this code and other codes in the 
family. We are assigning the RUC-recommended 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 understood the revised code description for CPT code 92543, 
and thus the survey data may be unreliable. 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 Transesophageal Echocardiography (TEE) (CPT Codes 
93312, 93313, 93314, 93315, 93316, 93317, 93318, 93355, and 93644)
    For CY 2015, CPT code 93355 was created to describe transesophageal 
echocardiography during interventional cardiac procedures. The RUC 
provided recommendations for CPT code 93355, and for CPT codes 93312-
93318 in order to ensure intra-family relativity. We are establishing 
the RUC-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, transoral; 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 morphology in the setting of 
congenital heart disease (including 3D image postprocessing, assessment 
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 believe 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 values 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 RUC recommendations for 
higher work RVUs. As we have stated in the absence of information 
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 
maintain appropriate relativity in the family. Additionally, we are 
refining the preservice and intraservice times for CPT codes 93314 and 
93317 to 10 and 20 minutes, respectively, to maintain relativity among 
the interim final work RVUs and times.
(19) Subcutaneous Implantable Defibrillator Procedures (CPT Codes 
33270, 33271, 33272, 33272, 93260, 93261 and 93644)
    For CY 2015, the CPT Editorial Panel added the word ``implantable'' 
to the descriptors for several codes in this family and created several 
new codes, CPT codes 33270, 33271, 33272, 33272, 93260, 93261 and 
93644. We received RUC recommendations for the new and revised codes. 
We are establishing the RUC-recommended 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 disagree with the 
RUC-recommended crosswalk for CPT code 93644 which has an intraservice 
time of 29 minutes and a total time of 115 minutes 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 are 
establishing a CY 2015 interim 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 
that the RUC consider CPT codes 93886, Transcranial Doppler study of 
the intracranial arteries; complete study, and 93888, Transcranial 
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 establishing the RUC-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

[[Page 67670]]

believe that this 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 are assigning an interim final work RVU of 0.50.
    For several codes in this family with 15 minutes of intraservice 
time, the RUC recommended work RVUs based upon the survey 25th 
percentile. We find this to appropriately reflect the work involved. 
Accordingly, for CPT codes 93975, 93976, and 93978, which all have 15 
minutes of intraservice time, we are disagreeing 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 interim 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 recommendation 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 code 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 Thickness Ultrasound (CPT Code 93895)
    For CY 2015, a new code, CPT code 93895, describes 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 for screening and therefore, we are assigning a PFS 
procedure status indicator of N (Noncovered service) to CPT code 93895.
(22) Doppler Flow Testing (CPT Code 93990)
    For CY 2015, the RUC provided a recommendation for CPT code 93990 
which had been identified through the High Volume Growth Services where 
Medicare utilization increased by at least 100 percent from 2006 to 
2011. The RUC 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 implanted 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 RUC recommended work 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 significant 
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 believe that the percent decrease in the work RVU 
from the base code 95972 should 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 
purposes this code should only be billed when a 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 along with the confusing 
descriptor language and intraservice time suggest the need for this 
family 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 typically 
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 provide a payment mechanism for negative pressure 
wound therapy services furnished to beneficiaries using equipment that 
is not paid for as durable medical equipment: G0456 (Negative pressure 
wound therapy, (for example, vacuum assisted drainage collection) using 
a mechanically-powered device, not durable medical equipment, including 
provision of cartridge and dressing(s), 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) and 
G0457 (Negative pressure wound therapy, (for example, vacuum assisted 
drainage collection) using a mechanically-powered device, not durable 
medical equipment, including provision of cartridge and dressing(s), 
topical application(s), wound assessment, and instructions for ongoing 
care, per session; total wound(s) surface area greater 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 pressure wound therapy, we are 
deleting the G-codes. We are contractor pricing these codes for CY 
2015. CPT codes 97607 and 97608 will be designated ``Sometimes 
Therapy'' on our Therapy Code List, which is consistent with the G-
codes. The Therapy Code List is available at http://www.cms.gov/Medicare/Billing/TherapyServices/index.html?redirect=/therapyservices.''
(25) Application of Topical Fluoride Varnish (CPT Code 99188)
    CPT Code 99188 is a new code for CY 2015 that describes the 
application of topical fluoride varnish to teeth. Since this code 
describes a service that involves the care of teeth, it is excluded 
from coverage under Medicare by section 1862(a)(12) of the Act, which 
provides ``items and services in connection with the care, treatment, 
filling, removal, or replacement of teeth, or structures directly 
supporting the teeth 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 
describing advance care planning services: CPT code 99497 (Advance care 
planning including 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 professional; first 30 
minutes, face-to-face with the patient, family member(s)

[[Page 67671]]

and/or surrogate); and an add-CPT code 99498 (Advance care planning 
including 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 professional; each additional 30 
minutes (List separately in addition to code for primary procedure)). 
For CY 2015, we are assigning a PFS status indicator of ``I'' (Not 
valid for Medicare purposes. Medicare uses another code for the 
reporting and payment of these services.) to CPT codes 99497 and 99498 
for CY 2015. However, we will consider whether to pay for CPT codes 
99497 and 99498 after we have had the opportunity 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, disposable supplies, and medical 
equipment, for new, revised, and potentially misvalued codes. We review 
the RUC-recommended direct PE inputs on a code-by-code basis, including 
the recommended facility PE inputs and/or nonfacility PE inputs. This 
review is informed by both our clinical assessment of the typical 
resource requirements for furnishing the service and our intention to 
maintain the principles 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 represent 
inputs that better reflect our estimate of the PE resources required to 
furnish the service in the facility 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 final 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 final, 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 
Web site at http://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/PhysicianFeeSched/PFS-Federal-Regulation-Notices.html. We also 
note that the PE RVUs displayed in Addenda B and C reflect the interim 
final values and policies described 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.

       Table 28--CY 2015 Interim 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
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 us
------------------------------------------------------------------------

ii. Common Refinements
    Table 31 details our refinements of the RUC's direct PE 
recommendations at the code-specific level. In this section, we discuss 
the general nature of some common refinements and the reasons for 
particular refinements.
(a) Changes in Physician Time
    Some direct PE inputs are directly 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 
corresponding changes to direct PE inputs. We also note that, for a 
significant number of services, especially diagnostic tests, the 
procedure time assumptions used in determining direct PE inputs are 
distinct from, and therefore not dependent on, work intraservice time 
assumptions. For these services, we do not make refinements to the 
direct PE

[[Page 67672]]

inputs based on changes to estimated work intraservice times.
    Changes in Intraservice Work Time in the Nonfacility Setting. For 
most codes valued in the nonfacility setting, a portion of the clinical 
labor time allocated to the intraservice period reflects minutes 
assigned for assisting the practitioner with the procedure. To the 
extent that we are refining the times associated with the intraservice 
portion of such procedures, we have adjusted the corresponding 
intraservice clinical labor minutes in the nonfacility setting.
    For equipment associated with the intraservice period in the 
nonfacility setting, we generally allocate time based on the typical 
number of minutes a piece of equipment is being used, and therefore, 
not available for use with another patient during that period. In 
general, we allocate these minutes based on the description of typical 
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 equipment minutes 
associated with the codes.
    Changes in the Number or Level of Postoperative 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 standard number of minutes allocated 
for each of those visits. To the extent that we are refining the number 
or level of postoperative visits, we have modified the clinical staff 
time in the 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 valued 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 valued 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 number of postoperative visits, we have adjusted the 
corresponding supply item quantities associated with the codes. We note 
that many supply items associated with postservice office visits are 
allocated for each office visit (for example, a minimum multi-specialty 
visit pack (SA048) in the CY 2015 direct PE input database). For these 
supply items, the quantities in the direct PE input 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 allocated once during the global period 
because they are typically used during only one of the postservice 
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 database reflect that single 
quantity.
    These refinements are reflected in the final CY 2015 PFS direct PE 
input database and detailed in Table 31.
(b) Equipment Minutes
    In general, the equipment time inputs reflect the sum of the times 
within the intraservice 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. In cases where equipment times included time for 
clinical labor activities in the pre-service period, we have refined 
these times to remove the minutes associated with these tasks, since 
the pre-service period ends ``when patient enters office/facility for 
surgery/procedure.'' Although some services include equipment that is 
typically unavailable during the entire clinical labor service period, 
certain highly technical pieces of equipment and equipment rooms are 
less likely to be used by a clinician for all tasks associated with a 
service, and therefore, are typically available for other patients 
during the preservice and postservice components of the service period. 
We adjust those equipment times accordingly. 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 where 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 length of time as 
the other equipment items in the standard package. We are refining the 
CY 2015 RUC direct PE recommendations to conform to these policies. 
This includes the removal of a power table where it was included during 
the intraservice period, as the stretcher 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 for Clinical Labor Tasks
    In general, the preservice, intraservice period, and postservice 
clinical labor minutes associated with clinical labor inputs in the 
direct PE input database 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 setting, its global period, and the other procedures with which 
it is typically reported. At times, the RUC recommends a number of 
minutes either greater than or less than the time typically allotted 
for certain tasks. In those cases, CMS reviews the deviations from the 
standards to assess whether they are clinically appropriate. Where the 
RUC-recommended exceptions are not accepted, we refine the interim 
final direct PE inputs to match the standard times for those tasks. In 
addition, in cases when a service 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 the typical service.
    In some cases the RUC recommendations include additional minutes 
described by a category called ``other clinical activity,'' or through 
the addition of clinical labor tasks that are different from those 
previously included as standard. In these instances, CMS reviews the 
tasks as described in the recommendation to determine whether they are 
already incorporated into the total number of minutes based on the 
standard tasks. Additionally, CMS reviews these tasks in the context of 
the kinds of tasks delineated for other 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 documentation tasks for 
services across the PFS are already accounted for in the overall 
estimate of clinical labor time. We do not believe that it would serve 
the relativity of the direct PE input database were additional minutes 
added for each clinical task that

[[Page 67673]]

could be discretely described for every code. These refinements are 
reflected in the final CY 2015 PFS direct PE input database and 
detailed in Table 31.
(e) New Supply and Equipment Items
    The RUC generally recommends the use of supply and equipment items 
that already exist in the direct PE input database for new, revised, 
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 historically 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 supply 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 period, we 
encourage stakeholders to review the prices associated with these new 
and existing items to determine whether these prices appear reasonable. 
Where prices appear unreasonable, we encourage stakeholders to provide 
invoices that provide more accurate pricing for these items in the 
direct PE database. We remind stakeholders that due to the budget 
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 are concerned that the single invoice may not be reflective 
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 information 
regarding the price of the item has been included in the recommendation 
to create a new item. In other cases, the supporting information does 
not demonstrate that the item has been purchased at the listed 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 included the item in the 
direct PE input database without an associated price. Although 
including the item without an associated price means that the item does 
not contribute to the calculation of the PE RVU for particular 
services, it facilitates our ability to incorporate a price once we are 
able to do so.

                                                  Table 29--Invoices Received for New Direct PE Inputs
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                                                                  Non-facility allowed
                                                                                                                                services for HCPCS codes
            CPT/HCPCS codes                       Item name            CMS code             Average price             No. of       using this item (or
                                                                                                                     invoices    projected services for
                                                                                                                                     new CPT codes*)
--------------------------------------------------------------------------------------------------------------------------------------------------------
20604, 20606, 20611....................  ultrasound transmission           SJ089   $1.71..........................          1                   748248*
                                          gel, sterile.
                                         (single use)..............
22512..................................  10g IVAS drill............        SD292   139.33.........................          1                       99*
22512..................................  10g cannulae..............        SD293   86.11..........................          1                       99*
29200, 29240, 29260, 29280, 29520,       foam underwrap............        SG097   0.0043 per inch................          1                    415513
 29530, 29540, 29550.
29200, 29240, 29260, 29280, 29520,       rigid strapping tape (15          SG098   0.018 per inch.................          1                    415513
 29530, 29540, 29550.                     yards).
29200, 29240, 29260, 29280, 29520,       skin prep barrier wipes...        SM029   0.20...........................          1                    415513
 29530, 29540, 29550.
31620..................................  Flexible dual-channeled           EQ361   160,260.06.....................          6                       107
                                          EBUS bronchoscope, with
                                          radial probe.
31620..................................  Video system, Ultrasound          ER099   13,379.57......................          6                       107
                                          (processor, digital
                                          capture, monitor,
                                          printer, cart).
31620..................................  EBUS, single use                      SC10145.82.........................          5                       107
                                          aspiration needle, 21 g.
31620..................................  Balloon for Bronchosopy           SD294   28.68..........................          4                       107
                                          Fiberscope.
52441, 52442...........................  Urolift Implant and               SD291   775.00.........................         10                       12*
                                          implantation device.
64486, 64488...........................  ultrasound needle.........            SC1012.81..........................          4                    46851*
64487, 64489...........................  continuous peripehral             SA116   23.69..........................          1                      802*
                                          nerve block tray.
77063..................................  multimodality software....        ED051   11,570.00......................         12                   297529*
88341..................................  Anti CD45 Monoclonal              SL495   3.61 per test..................          1                   917673*
                                          Antibody.
88344..................................  34 Beta E12...............        SL496   4.27 per test..................          1                    51591*
88348..................................  Digital Printer...........        ED048   774.89.........................          1                       641
88348..................................  Carbon Coater.............        EQ366   22,540.08......................          1                       641
88348..................................  Diamond Milling Tool......        EQ365   1,714.00.......................          1                       641
88356, 88348...........................  Electron Microscopy Tissue        EP115   13,119.00......................          2                     19134
                                          processor.
88356, 88348...........................  Block face milling machine        EQ363   18,139.00......................          1                     19134
88356, 88348...........................  Glass Knife Breaker.......        EQ364   9,585.14.......................          1                     19134
88364..................................  CMV DNA Probe Cocktail....        SL500   0.10 per ul....................          1                     3376*
88341, 88342, 88344, 88364, 88365,       Universal Detection Kit...        SA117   4.00...........................          1                   1380597
 88367, 88368, 88369, 88373.
88365..................................  EBER positive control             SL507   20.15..........................          1                      8440
                                          slide.
88365..................................  (EBER) DNA Probe Cocktail.        SL497   8.57 per test..................          2                      8440

[[Page 67674]]

 
88365, 88366, 88367, 88368, 88374,       VP-2000 Processor.........        EP116   30,800.00......................          1                    228243
 88377.
88367, 88368...........................  Kappa Probe Cocktails.....        SL498   0.10 per ul....................          1                     36634
88369, 88373...........................  Lambda Probe Cocktail.....        SL499   0.10 per ul....................          1                    24423*
88380, 88381...........................  Surface Decontaminant (DNA        SL494   0.07 per ml....................          1                      6649
                                          Away).
91200..................................  Fibroscan.................        ER101   124,950.00.....................          1                       87*
92145..................................  Ocular Response Analyzer..        EQ360   12,000.00......................          3                   Unknown
92541, 92542, 92544, 92545.............  VNG Recording System......        EQ367   29,607.50......................          2                    101139
93702..................................  BIS monitoring system             EQ359   3,316.93.......................          1                   Unknown
                                          (bioimpedance
                                          spectroscopy).
93702..................................  electrode, BIS                    SD290   28.33..........................          1                   Unknown
                                          (bioimpedance
                                          spectroscopy).
96127..................................  Beck Youth Inventory,             SK119   1.96 per booklet...............          1                   Unknown
                                          Second Edition (BYI-II);
                                          Combination Inventory
                                          Booklet.
97610..................................  MIST Therapy System.......        EQ372   28,000.00......................          2                        2*
97610..................................  MIST Therapy Cart.........        EQ368   1,250.00.......................          1                        2*
97610..................................  kit, low frequency                SA119   63.33..........................          3                        2*
                                          ultrasound wound therapy
                                          (MIST).
99188..................................  CavityShield 5% Varnish           SH106   0.91...........................          1                   Unknown
                                          .25mL.
G0277..................................  HBOT air break breathing          EQ362   986.00.........................          1                   153044*
                                          apparatus demand system
                                          (hoses, masks, penetrator
                                          and demand valve).
--------------------------------------------------------------------------------------------------------------------------------------------------------


                                                Table 30--Invoices Received for Existing Direct PE Inputs
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                                                                           Non-facility
                                                                                                                                             allowed
 CPT/HCPCS codes       Item name       CMS code           Current price                Updated price           % Change       No. of       services for
                                                                                                                             invoices      HCPCS codes
                                                                                                                                         using this item
--------------------------------------------------------------------------------------------------------------------------------------------------------
20983, 47383.....  cryosurgery             EQ302   missing....................  $37,500.00.................  ............            2             22 *
                    system (for
                    tumor ablation).
20983, 47383.....  gas, argon......        SD227   $0.25 per cubic foot.......  0.32 per cubic foot........           28             1             22 *
20983, 47383.....  gas, helium.....        SD079   0.25 per cubic foot........  0.57 per cubic foot........          128             1             22 *
31627............  system,                 EQ326   137,800.00.................  189,327.66.................           37             4               37
                    navigational
                    bronchoscopy
                    (superDimension
                    ).
31627............  kit, locatable          SA097   995.00.....................  1,063.67...................            7             3               37
                    guide, ext.
                    working
                    channel, w-b-
                    scope adapter.
64561............  kit,                    SA022   305.00.....................  420.00.....................           38             1             8229
                    percutaneous
                    neuro test
                    stimulation.
88348............  camera, digital         ED006   41,000.00..................  82,000.00..................          100             1              641
                    system, for
                    electron
                    microscopy.
88348, 88356.....  microtome, ultra        ER043   25,950.00..................  34,379.00..................           32             1            19134
G0277............  HBOT (hyperbaric        EQ131   125,000.00.................  127,017.98.................            2             1         153044 *
                    oxygen therapy)
                    monochamber,
                    incl. gurney
                    and integrated
                    grounding
                    assembly.
--------------------------------------------------------------------------------------------------------------------------------------------------------
* New procedure--Projected volume.


[[Page 67675]]

(f) Recommended Items That Are Not Direct PE Inputs
    In some cases, the recommended direct PE inputs included items that 
are not clinical labor, disposable supplies, or medical equipment 
resources. We have addressed these kinds of recommendations in previous 
rulemaking and in sections 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 database and 
detailed in Table 31.
(g) Film-to-Digital Migration
    As discussed in section II.A.3 of this final rule with comment 
period, we are finalizing our policy to remove equipment and supply 
inputs 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 recommendations included 
film inputs. Where recommendations included these inputs, we have 
removed these inputs and replaced them with ``PACS workstation proxy'' 
as described in section II.A.3 of this final rule with comment period. 
Since the film-to-digital transition results from our acceptance of a 
RUC recommendation, we do not consider the removal of these items to be 
refinements of RUC 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-service 
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 codes. In these cases, we removed the 
time associated with those tasks and/or equipment items from those 
codes. These refinements appear in Table 31.
iii. Code-Specific Refinements
(a) Rib Fractures (CPT Codes 21811, 21812, and 21813)
    For the newly created rib fracture codes, which are frequently 
furnished as emergency surgeries, the RUC did not include time for the 
standard pre-service activities ``Provide pre-service education/obtain 
consent'' and ``Follow-up phone calls & prescriptions.'' However, the 
RUC recommendation included time for pre-service activities ``Complete 
pre-service diagnostic & referral forms,'' ``Coordinate pre-surgery 
services'', and ``Schedule space and equipment in facility.'' Since 
these codes would typically be provided as emergency surgeries, we 
question whether these tasks would typically be performed.
    We reviewed other emergency procedures in the PFS to determine 
whether pre-service clinical labor activities were typically included 
in the 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 this time. However, we 
believe that for emergency procedures, none of the pre-service tasks 
listed above would typically 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 
the postoperative visits.
(b) Percutaneous Vertebroplasty and 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 performed), 1 
vertebral body, unilateral or bilateral injection, inclusive of all 
imaging guidance, each additional cervicothoracic or lumbosacral 
vertebral body)) included new supply item ``10g IVAS drill.'' We note 
that the recommendations for the base codes did not contain this supply 
item, and the vertebroplasty kit does not appear to contain this drill 
either. We do not understand 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(Digital breast 
tomosynthesis; unilateral), 77062 (Digital breast tomosynthesis; 
bilateral) and 77063 (Screening digital breast tomosynthesis, bilateral 
(List separately in addition to code for primary procedure)). For these 
newly created codes, the RUC recommended creating a new equipment item, 
``room, breast tomosynthesis'', at a price of $667,669, as well as a 
list of items contained in the room. We believe that several of the 
items included in the room are not appropriately characterized as 
direct costs. 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 specialty 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 equipment item, but 
will instead include the individual equipment items that we believe are 
appropriately 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 
for this equipment item with an average price of $381,380. Therefore, 
we will create a new equipment item ``DBT unit'', at a price of 
$381,380.
    The RUC also recommended including a new equipment item, ``PACS 
cache'', for these procedures. We do not believe that 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 
included 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 
requested 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 
valuing new, revised, and potentially misvalued codes, it is prudent to 
propose the values for the revised code set in the CY 2016 rule

[[Page 67676]]

with opportunity for public comment prior to establishing payment 
rates.
(f) Immunohistochemistry (CPT Codes 88341, 88342, and 88344)
    The RUC recommended including supply item ``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 services, CPT codes 88364, 88365, 88367, 88368, 
88369, and 88373, the RUC recommended including supply item ``Universal 
Detection Kit'' (SA117), which is priced at $4.00 per kit. After 
reviewing information about these 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 the 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 supply item, ``diamond milling 
tool'', for use with CPT code 88348. However, upon reviewing the 
invoice, we believe that ``diamond milling tool'' is more appropriately 
characterized 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 hybridization codes 
(88365, 88367, and 88368) and created three new add-on codes for 
reporting each additional separately identifiable probe per slide. The 
RUC reviewed CPT 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'' 
(SL195), 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 clarification was 
necessary, and requested that the CPT Editorial Panel review the entire 
family again. The CPT editorial panel added three new codes for ``each 
multiplex probe stain procedure.'' The specialty societies then 
resurveyed these procedures. The RUC reviewed the entire family at the 
April 2014 meeting 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 one unit for CPT code 88368. Without 
an explanation for 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 was 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 describe 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 control slides and 
negative control slides should be consistent throughout this entire 
family. 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 maintain consistency 
throughout this family of codes.
    As with the positive and negative control slides, we believe that 
the number of units of supply item SL498 (``Kappa probe cocktails'') 
and SL499 (Lambda probe cocktails'') should be consistent across 
procedures. The recommendations 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 therefore 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. However, in the recommendations we received, rather than 
the clinical labor time for these codes decreasing 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 time for this same clinical labor task. Therefore, 
we will not allocate time for equipment item ``VP-2000 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 microdissection is performed by the 
pathologist. 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 cytotechnologist are 
completing these tasks, we have refined out the lines associated with 
the specific tasks we believe are completed by the pathologist. Table 
31 details our refinements to the clinical labor tasks.
(j) Interventional Transesophageal Echocardiography (TEE) (CPT Codes 
93312 and 93314)
    CPT code 93314 describes a service in which the acquisition and 
interpretation of images is furnished by a different practitioner than 
the placement of the

[[Page 67677]]

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 code. We have 
therefore refined this time to 30 minutes, which is the same as the 
time allocated to 93312. We also note that the time allocated to 
equipment item ``room, ultrasound, vascular'' (EL016) was affected by 
this refinement.
(k) Hyperbaric Oxygen Therapy (HBOT) (HCPCS Code G0277)
    We received a RUC recommendation for CPT code 99183 (Physician or 
other qualified health care professional attendance 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 treatment 
delivery. Stakeholders have 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 considering this issue, we believe the OPPS approach would also 
be appropriate for the PFS. We are therefore creating a G-code to 
report the treatment delivery and to maintain consistency with the OPPS 
coding. We will use the 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.
    In reviewing the recommended direct PE inputs, 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 used. 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 this 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 applicable standard and common 
refinements for these codes, are reflected in the final CY 2015 PFS 
direct PE input database and detailed in Table 31.
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BILLING CODE 4120-01-C
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 
subject to the DRA cap, effective January 1, 2015. The codes are: 
(76641 (Ultrasound breast complete), 76642 (Ultrasound breast limited), 
77085 (Dxa bone density study), 77086 (Fracture assessment via dxa), 
77387 (Guidance for radiaj tx dlvr), G6001 (Stereoscopic x-ray 
guidance), and G6002 (Echo guidance radiotherapy). These codes, which 
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 codes 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 discussed in section II.C, 
we are assigning malpractice RVUs for CY 2015 new, revised, and 
potentially misvalued codes by utilizing a crosswalk to a source code 
with a similar malpractice risk. We have reviewed the RUC recommended 
malpractice source code crosswalks for CY 2015 new, revised, and 
potentially misvalued codes, and we are accepting all of them on an 
interim final basis for CY 2015. For G-codes that we are creating, we 
are also assigning source code crosswalks to similar codes.
    Table 32 lists the CY 2015 HCPCS codes and their 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 final 
rule with comment period.
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BILLING CODE 4120-01-C

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 increasingly 
recognized care management as one of the critical components of primary 
care that contributes 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 designed to 
improve payment for, and encourage long-term investment in, care 
management services. These initiatives include the following programs 
and demonstrations:
    <bullet> The Medicare Shared Savings Program (described in 
``Medicare Program; Medicare Shared Savings Program: Accountable Care 
Organizations; Final Rule,'' which appeared in the November 2, 2011 
Federal Register (76 FR 67802)).
    <bullet> The testing of the Pioneer ACO model, designed for 
experienced health care organizations (described on the Centers for 
Medicare and Medicaid Innovation's (Innovation Center's) Web site at 
http://innovation.cms.gov/initiatives/Pioneer-ACO-Model/index.html).
    <bullet> The testing of the Advance Payment ACO model, designed to 
support organizations participating in the Medicare Shared Savings 
Program (described on the Innovation Center's Web site at http://innovation.cms.gov/initiatives/Advance-Payment-ACO-Model/).
    <bullet> The Primary Care Incentive Payment (PCIP) Program 
(described on the CMS Web site at www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/PhysicianFeeSched/Downloads/PCIP-2011-Payments.pdf).
    <bullet> The patient-centered medical home model in the Multi-payer 
Advanced Primary Care Practice (MAPCP) Demonstration designed to test 
whether the quality and coordination of health care services are 
improved by making advanced primary care practices more broadly 
available (described on the CMS Web site at www.cms.gov/Medicare/Demonstration-Projects/DemoProjectsEvalRpts/downloads/mapcpdemo_Factsheet.pdf).
    <bullet> The Federally Qualified Health Center (FQHC) Advanced 
Primary Care Practice demonstration (described on the CMS Web site at 
http://www.cms.gov/Medicare/Demonstration-Projects/DemoProjectsEvalRpts/Downloads/FQHC_APCP_Demo_FAQsOct2011.pdf and the 
Innovation Center's Web site at www.innovations.cms.gov/initiatives/FQHCs/index.html).
    <bullet> The Comprehensive Primary Care (CPC) initiative (described 
on the Innovation Center's Web site at http://innovations.cms.gov/initiatives/Comprehensive-Primary-Care-Initiative/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 
conditions. HHS's Strategic Framework on Multiple Chronic Conditions 
outlines specific objectives and strategies for HHS and private sector 
partners centered on strengthening the health care and public health 
systems; empowering the individual to use self-care management with the 
assistance of a healthcare provider who can assess the patient's health 
literacy level; equipping care providers with tools, information, and 
other interventions; and supporting targeted research about individuals 
with multiple chronic conditions and effective interventions. Further 
information on this initiative is available on the HHS Web site at 
http://www.hhs.gov/ash/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-service physician payment and quality reporting. 
For example, in the CY 2013 PFS final rule with comment period, we 
adopted a policy to pay separately for care management involving the 
transition of a beneficiary from care furnished by a treating physician 
during a hospital stay to care furnished by the beneficiary's primary 
physician 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 furnished to 
Medicare beneficiaries with two or more chronic

[[Page 67716]]

conditions beginning in CY 2015 (78 FR 74414).
1. Valuation of CCM Services--GXXX1
    CCM is a unique PFS service designed to pay separately for non-
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 
rule 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):
    <bullet> GXXX1 Chronic care management services furnished to 
patients with multiple (two or more) chronic conditions expected to 
last at least 12 months, or until the death of the patient, that place 
the patient at significant risk of death, acute exacerbation/
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 codes include care 
management components. To value CCM, we compared it to other codes that 
involve care management. In doing so, we concluded that the CCM 
services were similar in work (time and intensity) to that of the non-
face-to-face portion of the lower level code for transitional care 
management (TCM) services (CPT code 99495 (Transitional Care Management 
Services with the following required elements: Communication (direct 
contact, telephone, electronic) with the patient and/or caregiver 
within 2 business days of discharge Medical decision making of at least 
moderate complexity during the service period face-to-face visit, 
within 14 calendar days of discharge)). Accordingly, we based the 
proposed inputs on the non-face-to-face portion of CPT code 99495.
    Specifically, we proposed a work RVU for GXXX1 of 0.61, which is 
the portion of the work RVU for CPT code 99495 that remains after 
subtracting the work attributable to the face-to-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 attributable 
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 comment period, 
in order to bill for this 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 care 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 non-face-to-face clinical labor time and we assumed the 
typical case for CCM would involve 20 minutes based upon the code 
descriptor and a broad eligible population that would require limited 
monthly services. The proposed CY 2015 direct PE input database 
reflected the input of 20 minutes of clinical labor time and is 
available on the CMS Web site under the supporting data files for the 
CY 2015 PFS proposed rule at http://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/PhysicianFeeSched/PFS-Federal-Regulation-Notices.html. The resulting proposed PE RVUs were 0.57 for CCM 
furnished in non-facility locations and 0.26 for CCM furnished in a 
facility.
    The proposed MP RVU of 0.04 was calculated using 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 proposed valuation. In 
general, the commenters commended CMS for ongoing recognition of the 
value of non-face-to-face time expended by physicians and staff to 
improve outcomes for beneficiaries with chronic conditions, and the 
proposal to pay separately for the non-face-to-face services. However, 
the commenters generally believed the proposed valuation for CCM 
services underestimated the resources involved with complex 
beneficiaries, and recommended various alternatives for valuing the 
services. We summarize these comments in the following paragraphs.
    Comment: Several commenters noted that the CPT Editorial Panel 
created a new code for CY 2015 that is extremely similar to the G-code 
we developed to report these services. These commenters suggested that 
we use the new CPT code 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:
    <bullet> Multiple (two or more) chronic conditions expected to last 
at least 12 months, or until the death of the patient;
    <bullet> Chronic conditions place the patient at significant risk 
of death, acute exacerbation/decompensation, or functional decline;
    <bullet> Comprehensive care plan established, implemented, revised, 
or monitored).
    Many of these commenters expressed a preference for the ``per 
calendar month'' used in the CPT descriptor to the ``per 30 days'' used 
in the G-code. The commenters said a calendar month rather than 30 days 
would be less complex administratively.
    Response: It is our preference to use CPT 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 consider using a CPT code if one was created that 
reflected the service we were describing with the G-code. We believe 
that the new CPT code 99490 appropriately describes CCM services for 
Medicare beneficiaries.
    We had used 30 days rather than a calendar month as the service 
period for the G-code so that the number of days in the service period 
would not vary based upon when CCM services were initiated for a given 
period. For example, if the services were initiated near the end of a 
calendar month, using the CPT code's period of ``per calendar month'' 
would make it harder for the practitioner to meet the required minimum 
time for the month and be able to bill CMM for that month.
    However, after learning about the administrative difficulties that 
the 30-day period would create, we believe that the calendar month 
creates 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 alternative approaches to the 
use of codes that describe CCM services. For example, one commenter 
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 patients (those whose condition is less well controlled) 
will demand more attention and care than average patients, while those 
whose condition is well controlled might require very little attention. 
This commenter suggested that a reasonable solution would be for the 
care minutes per patient per month to be calculated as an average 
across a number of CCM

[[Page 67717]]

patients. The commenter added that for patients entering and exiting 
mid-month, the average minutes of care could be calculated on a pro 
rata basis which adjusts for the partial months they are eligible for 
CCM services. Several other commenters said that CMS should use a 
capitated payment methodology for CCM services in the long run, but 
supported CCM services 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 
demonstration initiatives to all physicians. Others commented similarly 
that the long-term goal is capitated payments like the demonstrations/
models that better encourage population-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 annual 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). Based 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-to-face and non-face-to-face time per 
month. Assuming the same care manger salary and patient load, the 
commenters asserted that the monthly payment amount necessary to 
provide this amount of care would be $83 per beneficiary per month.
    Response: Our proposal to pay separately for these services is part 
of a broader series of potential refinements to the PFS that 
appropriately value care management within Medicare's statutory 
structure for fee-for-service physician payment. We do not have 
statutory authority to base payment under the PFS on a recurring per 
beneficiary per month basis. The PFS is limited to a fee-for-service 
model at present, and as such we do not use capitated payment for 
services that may or may not be furnished in a given month. We refer 
the commenter and other interested stakeholders to the preceding 
paragraphs that describe a broader set of initiatives that are designed 
to improve payment for, and encourage long-term investment in, care 
management services, including a variety of CMS and HHS programs and 
demonstrations.
    Comment: Many commenters recommended a higher valuation for CCM 
services than was proposed, with some commenters providing specific 
suggestions as to changes in inputs and others simply asserting that a 
higher payment was appropriate or necessary to achieve access or the 
desired benefit. One commenter recommended a payment of $75 but did not 
provide supporting information. Several other commenters recommended 
that CMS adopt the RUC-recommended values for CPT code 99490 (work time 
of 30 minutes, work RVU of 1.0, and 60 minutes of clinical labor time). 
Several commenters believed CMS should adopt the work, PE and MP RVUs 
for CPT code 99495, with one commenter 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 
beneficiary per month payment that is made for similar services through 
a state Medicaid program. Another commenter pointed out that the 
proposed combined MP and PE RVU of 0.61 for CCM is significantly lower 
than for the following similar services that cannot be billed during 
same period with CCM: HCPCS code G0181 (Home Healthcare Oversight) 
which has a combined MP and PE RVU of 1.28; HCPCS code G0182 (Hospice 
Care Plan Oversight) which has a combined MP and PE RVU of 1.30; CPT 
code 99339 (Care Plan Oversight Services) which has a combined 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. This commenter believed the time and 
intensity required for the non-face-to-face portion of CPT code 99495 
is not the same as for CCM services.
    Several commenters suggested that CMS should develop PE RVUs for 
the service using alternative methodologies than for other PFS 
services. For example, several commenters stated that CMS should adjust 
the PE RVUs to account for major infrastructure and other costs 
required for CCM, especially health information technology, computer 
equipment, 24/7 beneficiary access, extensive documentation, nursing 
staff and other overhead costs. One commenter believed the proposed 
RVUs accounted for personnel costs but not the practice expense for 
health information technology, workforce retooling, and analytics.
    We received many public comments on the appropriate 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 25th 
percentile for work time in the RUC survey, and they noted the 
significantly higher time reported in response to the RUC survey of 60 
minutes of clinical labor time. Another commenter said that assuming 20 
minutes of service time per month as typical significantly undervalues 
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 recommendation 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 services, with the following 
required elements:
    <bullet> Multiple (two or more) chronic conditions expected to last 
at least 12 months, or until the death of the patient;
    <bullet> Chronic conditions place the patient at significant risk 
of death, acute exacerbation/decompensation, or functional decline;
    <bullet> Establishment or substantial revision of a comprehensive 
care plan;
    <bullet> Moderate or high complexity medical decision making;
    <bullet> 60 minutes of clinical staff time directed by a physician 
or other qualified health care professional, per calendar month).
    However several commenters did not object to the proposed valuation 
for GXXX1 and recommended that CMS monitor payment adequacy and 
appropriate valuation once the code is implemented.
    Response: After consideration of the various comments on the work 
RVUs, we continue to believe that the most appropriate mechanism for 
determining the appropriate work RVU for this service is by using the 
non-face-to-face portion of the lower level TCM code, CPT code 99495. 
We continue to believe

[[Page 67718]]

that the work and intensity for CCM services furnished to the eligible 
beneficiaries is comparable to the work and intensity involved in 
furnishing the non-face-to-face portion of the service described by CPT 
code 99495. Therefore, we believe that using CPT code 99495 as the 
comparison code assures 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 minutes and 
also are furnished to significantly different patient populations.
    We appreciate commenters' concerns regarding the various kinds of 
practice expense and malpractice liability costs that practices incur 
as they manage beneficiaries requiring CCM services. However, we 
continue to believe that our established PE and MP methodology used to 
value the wide ranges of services across the PFS assures that we have 
the appropriate 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 believe 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 are 
required to be furnished in order to report the service and our 
information, 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 believe 60 minutes would 
overestimate the typical number of clinical labor minutes during one 
month for the typical eligible beneficiary. Accordingly, we are 
finalizing our proposed work and clinical labor times.
    Comment: A number of commenters recommended that coinsurance should 
not apply to CCM services. These commenters were concerned 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 beneficiary cost sharing. 
They noted that cost-sharing will make it challenging to reach the 20 
minutes required for billing, because beneficiaries will delay care 
until face-to-face is necessary.
    Response: CCM services do not fall into any of the statutory 
preventive services benefit categories of the Act. The Secretary has 
the authority 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 has not earned such a 
rating. Since CCM does not meet the criteria, we cannot designate it as 
an additional preventive 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 services. As discussed 
in the CY 2014 PFS final rule with comment period (78 FR 74424), in 
order to assure that beneficiaries are aware of the coinsurance for 
this non-face-to-face service, we are requiring that providers explain 
to beneficiaries the cost-sharing obligation involved in receiving CCM 
services and obtain their consent prior to furnishing the service. 
Practitioners should explain 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 services that entail greater cost-sharing.
    Comment: Most of the commenters were concerned that the proposed 
payment would not be adequate for beneficiaries with complex needs who 
would benefit the most from CCM services. Most of the commenters 
recommended that we adopt more than one code to provide differential 
payment for more and less complex beneficiaries, using CPT CCM codes, 
G-code(s) or some combination thereof. Many commenters distinguished 
between beneficiaries that require significantly different clinical 
resources--those needing ``complex chronic care management'' and those 
needing only ``standard chronic 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 
ambiguity in the descriptor will result in use of GXXX1 to treat a very 
broad spectrum of beneficiaries inconsistent with the scope of service 
that the commenters believed was consistent with beneficiaries with 
more complex needs. They believed the proposed payment amount is 
appropriate for beneficiaries on needing only standard chronic care 
management, but would significantly underpay for beneficiaries 
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 that 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 CPT 
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 month (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 values, to describe CCM for the two 
distinct populations that require different services. These commenters 
stated that there is no ``typical'' patient that characterizes both 
groups of patients, and that a large number of eligible beneficiaries 
(those having 2 or more chronic conditions) have serious 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 for each additional 20 minutes or other time spent caring 
for a beneficiary with more complex needs. One commenter urged CMS to 
adopt an add-on 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 impacts 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 services 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

[[Page 67719]]

recommended that CMS adopt a higher intensity 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 beneficiaries with 
two or more chronic conditions as defined under the CCM code can 
benefit from care management and want to make this service available to 
all such beneficiaries. Like all services, we recognize that some 
beneficiaries will need more services and some less, and thus we pay 
based upon the typical service. However all scope of service elements 
apply for delivery of CCM services to any eligible Medicare 
beneficiary. We will evaluate the 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 payment 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 that CMS create codes 
specific to remote patient biometric monitoring (recording vital signs 
and other physiological data and transmitting real-time data to 
physicians). Several commenters requested codes specific to or 
inclusive of certain hematology, nephrology, endocrine and allergy/
immunology conditions, such as chronic kidney disease, end-stage renal 
disease, diabetes 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 least two chronic conditions. As noted above, we will be 
monitoring this service and will consider making changes if they appear 
warranted.
    After consideration of the comments 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 closely to assess whether the service is targeted to the 
right population and whether the payment is appropriate for the 
services being furnished. As part of our evaluation, 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 comment period (78 FR 74425 
through 74427), we discussed how the policies relating to services 
furnished incident to a practitioner's professional services apply to 
CCM services. (In this discussion, the term practitioner means both 
physicians and NPPs who are permitted to bill for services furnished 
incident to their own professional services.) Specifically, we 
addressed 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 
services furnished incident to the services of a billing practitioner. 
Generally, under the ``incident to'' rules, practitioners may bill for 
services furnished incident to their own services if the services meet 
the requirements specified in our regulations at Sec.  410.26. One of 
these requirements is that the ``incident to'' services must be 
furnished under direct supervision, which means that the supervising 
practitioner must be present in the office suite and be immediately 
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-week, to address the beneficiary's chronic care 
needs (78 FR 74426), we expect the beneficiary to be provided with a 
means to make timely contact with health care providers in the practice 
whenever necessary to address chronic care needs regardless of the time 
of day or day of the week. In those 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 would 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 
``incident to'' services must be furnished under direct supervision. 
Specifically, we finalized a policy to require only general, rather 
than direct, supervision when CCM services are furnished incident to a 
practitioner'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, given the potential risk to beneficiaries 
that the exception to direct supervision could create, we believed 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 requirement by ensuring that 
there is a direct oversight relationship between the supervising 
practitioner 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 services furnished incident to a practitioner's services. 
Specifically, we proposed to remove the 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 direct employee of the practitioner or the practitioner's 
practice. (We note that the existing requirement that these services be 
provided by clinical staff, specifically, rather than by other 
auxiliary personnel is an element of the service for both CCM and TCM 
services, rather than a requirement imposed by the ``incident to'' 
rules themselves.) We also proposed to remove the restriction that 
services provided by clinical staff under general (rather than direct) 
supervision may 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 counted toward the CCM time requirement at any time, 
provided that the clinical staff are under the general supervision of a 
practitioner and all other requirements of the ``incident to'' 
regulations at Sec.  410.26 are met.
    We proposed to revise these aspects of the policy for several 
reasons. First, one of the required elements of the CCM service is the 
availability of a means for the beneficiary to make contact with

[[Page 67720]]

health care practitioners in the practice to address a beneficiary's 
urgent chronic care needs (78 FR 74418 through 74419). Other elements 
within the 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 service require the presence of an organizational 
infrastructure sufficient to adequately support CCM services, 
irrespective of the nature of the employment or contractual 
relationship between the clinical staff and the practitioner or 
practice. We also believe that the elements of the CCM scope of 
service, such as the requirement of a care plan, ensure a close 
relationship between a practitioner furnishing ongoing care for a 
beneficiary and clinical staff providing aspects of CCM services under 
general supervision; and that this close working relationship is 
sufficient to render a requirement of a direct employment relationship 
or direct supervision unnecessary. Under our proposal, CCM services 
could be furnished ``incident to'' if the services are provided by 
clinical staff under general supervision of a practitioner whether or 
not they are direct employees of the practitioner or practice that is 
billing for the service; but the clinical staff must meet the other 
requirements for auxiliary personnel including those at Sec.  
410.26(a)(1). Other than the exception to permit general supervision 
for clinical staff, the same requirements apply to CCM services 
furnished incident to a practitioner'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 provision of CCM services. These consultations have convinced 
us that, for purposes of clinical staff providing aspects of CCM 
services, it does not matter whether the practitioner is directly 
available to supervise because the nature of the services are such that 
they can be, and frequently 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 revision to the requirements for 
CCM services provided by clinical staff incident to the services of a 
practitioner, we also proposed to adopt the same requirements for 
equivalent purposes in relation to TCM services. As in the case of CCM, 
TCM explicitly includes separate payment for services that are not 
necessarily furnished face-to-face, such as coordination with other 
providers and follow-up with beneficiaries. It would also not be 
uncommon for auxiliary personnel 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 services similarly whether in the form of CCM or TCM. We 
also believe that it would be appropriate to apply the same ``incident 
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 still be furnished under direct supervision.
    Therefore, we proposed to revise our regulation at Sec.  410.26, 
which sets out the applicable requirements for ``incident to'' 
services, to permit TCM and CCM services provided by clinical staff 
incident to the services of a practitioner to be furnished under the 
general supervision of a physician or other practitioner. As with other 
``incident to'' services, the physician (or other practitioner) 
supervising the auxiliary 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 apply 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 Sec.  410.26, which sets out the applicable requirements 
for ``incident to'' services, to permit TCM and CCM services provided 
by clinical staff incident to the services of a practitioner 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, provided that the 
clinical staff are under the general supervision of a practitioner and 
all requirements of the revised ``incident to'' regulations at Sec.  
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 incident to a 
practitioner's professional services (under the ``incident to'' 
regulations) to be included and reported as CCM services. We are not 
entirely clear what the commenter is asking, but the time spent 
furnishing 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 educational materials, practitioners 
who furnish Medicare covered items and services are responsible for 
learning how to appropriately bill each service.
    Comment: One commenter urged us to revise the terminology by which 
we define the CCM and TCM services to reflect non-hierarchical 
interdisciplinary team care, rather than relying on an incident-to 
structure 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 supervision'' 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 transparency in billing data 
and diminish accountability for services for Part B beneficiaries.
    Response: We do not entirely understand the 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 time toward the TCM and CCM requirements. We have not 
otherwise proposed to revise the ``incident to'' and other regulations 
within which practitioners operate as they make decisions about whether 
to contract or directly employ clinical staff, or about how to bill for 
services provided. Although they are important 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 
peripheral in the context of the overall employment and billing 
practices of physicians and group practices.
    After consideration of the comments, we are finalizing our proposal 
to revise our regulation at Sec.  410.26, which sets out the applicable 
requirements for ``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

[[Page 67721]]

to be furnished under 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 for CCM that 
are required for a practitioner to bill Medicare for the CCM service. 
In addition, we indicated 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 soliciting 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 collaborating with federal partners 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 Health Information Technology (ONC), and the Health Resources and 
Services Administration. Our goal is to recognize the trend toward 
practice transformation and overall improved quality of care, while 
preventing unwanted and unnecessary care.
    As we worked to develop appropriate practice standards that would 
meet this goal, we consistently found that many of the standards we 
thought were important overlapped in significant ways with the scope of 
service or with the billing requirements for the CCM services that had 
been finalized in the CY 2014 final rule 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 requirements 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 standards and requirements that are already in place for health 
care practitioners and applicable to those who furnish and bill for CCM 
services, we decided not to propose an additional set of standards 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 scope 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.
    <bullet> 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 
patient 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.
    <bullet> Continuity of care with a designated practitioner or 
member of the care team with whom the patient is able to get successive 
routine appointments.
    <bullet> Care management for chronic conditions including 
systematic assessment of the patient's medical, functional, and 
psychosocial needs; system-based approaches to ensure timely receipt of 
all recommended preventive care services; medication reconciliation 
with review of adherence and potential interactions; and oversight of 
patient self-management of medications.
    <bullet> In consultation with the patient, any caregiver and other 
key 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, mental, cognitive, 
psychosocial, functional and environmental (re)assessment and an 
inventory of resources and supports. It is a comprehensive plan of care 
for all health issues, and typically includes, but is not limited to, 
the following elements: problem list, expected outcome and prognosis, 
measurable treatment goals, symptom management, planned interventions, 
medication management, community/social services ordered, how the 
services of agencies and specialists unconnected to the billing 
practice will be directed/coordinated, identify the individuals 
responsible for each intervention, requirements for periodic review 
and, when applicable, revision 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.
    <bullet> 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 providers regarding these transitions. The practice 
must also have qualified personnel who are available to deliver 
transitional 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 facilities or other health 
care facilities.
    <bullet> Coordination with home and community based clinical 
service providers required to support the patient's psychosocial needs 
and functional deficits. Communication to and from home and community 
based providers regarding these patient needs must be documented in the 
patient's medical record.
    <bullet> Enhanced opportunities for the beneficiary and any 
relevant caregiver to communicate with the practitioner regarding the 
beneficiary's care through, not only telephone access, but also through 
the use of secure messaging, internet or other asynchronous non face-
to-face consultation methods.
    Similarly, we reminded stakeholders of the following additional 
billing requirements established in the CY 2014 final rule with comment 
period (in the following list, we have changed the service period from 
the 2015 proposed 30-day period to the final 2015 service period of one 
calendar month):
    <bullet> 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, including the beneficiary's 
authorization for the electronic communication of the patient's medical 
information with other treating providers as part of care coordination.
    <bullet> Document in the beneficiary's medical record that all 
elements of the CCM service were explained and offered to the 
beneficiary, and note the beneficiary's decision to accept or decline 
the service.
    <bullet> Provide the beneficiary a written or electronic copy of 
the care plan and document in the electronic medical record that the 
care plan was provided to the beneficiary.
    <bullet> Inform the beneficiary of the right to stop the CCM 
services at any time (effective at the end of a calendar month) and the 
effect of a revocation of the agreement to receive CCM services.
    <bullet> Inform the beneficiary that only one practitioner can 
furnish and be paid for

[[Page 67722]]

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 primary 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 
communication and exchange of information with the patient and among 
the various health care practitioners and providers treating the 
patient. After gathering input from stakeholders through the CY 2014 
rulemaking cycle, for 2015 we proposed a new scope of service element 
that would require use of a certified EHR and electronic care planning 
to furnish CCM services. We believed that requiring those who furnish 
CCM services to utilize EHR technology that has been certified 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 
practitioners and providers involved in managing the patient's chronic 
conditions, otherwise care could not be coordinated and managed. 
Requiring a certified EHR would enable members of the interdisciplinary 
care team to have immediate access to the most updated information 
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 identified 
in the then-applicable version of 45 CFR part 170. We proposed that at 
a minimum, the practice must utilize EHR technology that meets the 
certification criteria adopted at 45 CFR 170.314(a)(3), 170.314(a)(4), 
170.314(a)(5), 170.314(a)(6), 170.314(a)(7) and 170.314(e)(2) 
pertaining to the capture of demographics, problem lists, medications, 
and other key elements related to the ultimate creation of an 
electronic summary care record. These sections of the regulation 
comprise the certification criteria for specific core technology 
capabilities (structured recording of demographics, problems, 
medications, medication allergies, and the creation of a structured 
clinical summary) for the 2014 edition. Under the proposal, 
practitioners furnishing CCM services beginning in CY 2015 would be 
required to utilize an EHR certified to at least these 2014 edition 
certification criteria. Given these 2014 edition criteria, the EHR 
technology would be certified to capture data and ultimately produce 
summary records according to the HL7 Consolidated Clinical Document 
Architecture standard (see 45 CFR 170.205(a)(3)).
    In addition, when any of the CCM scope of service elements refers 
to a health or medical record, we proposed to require use of an EHR 
certified to at least the 2014 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:
    <bullet> A full list of problems, medications and medication 
allergies in the EHR must inform the care plan, care coordination and 
ongoing clinical care.
    <bullet> 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.
    <bullet> Inform the beneficiary of the availability of CCM services 
and obtain his or her written agreement to have the services provided, 
including authorization for the electronic communication of his or her 
medical information with other treating 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.
    <bullet> Provide the beneficiary a written or electronic copy of 
the care plan and document in the electronic medical record that the 
care plan was provided to the beneficiary.
    Regarding the care plan in particular, we believed 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 systematically reconciled. To ensure that practices 
offering CCM services meet these needs, we proposed that CCM services 
must be furnished with the use of an EHR or other health IT or health 
information exchange 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 
business hours, and that is available to be shared electronically with 
care team members outside of the practice. This was a more 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 
beneficiary's full electronic medical record (78 FR 74416 through 
74417).
    Regarding the clinical summary, we proposed to require technology 
certified to the 2014 edition for the electronic creation of the 
clinical summary, formatted according to the standard adopted at 45 CFR 
170.205(a)(3), but we did not specify 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 services must adopt 
certified technology related to the exchange of a summary care record 
such as the transmission standard related to Direct Project Transport 
in 45 CFR 170.314(b)(2)(ii).
    We indicated that we believed our proposed new 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 innovate around the systems that they use to 
furnish these services, and avoid overburdening small practices. We 
indicated that we believed that allowing flexibility as to how 
practitioners capture, update, and share care plan information was 
important at this stage given the maturity of current 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 the practitioners who bill for these services have the 
capability to furnish them and that we can appropriately monitor 
billing for these services. With the addition of the electronic health 
information technology element that we proposed, we believed that the 
elements of the scope of service for CCM services, when combined with 
other important federal health and safety regulations, would provide 
sufficient assurance that practitioners billing for CCM could fully 
furnish the services, and that Medicare beneficiaries receiving CCM 
would receive appropriate services. However we expressed special 
interest in receiving public feedback regarding any meaningful elements 
of the CCM service or beneficiary protections that may be missing from 
the scope of service elements and billing requirements.
    The following paragraphs summarize the comments we received 
regarding

[[Page 67723]]

these elements of the scope of service for CCM services and our 
responses.
    Comment: Some commenters were disappointed that CMS did 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 further development of standards 
such as inclusion of evidence-based self-management programs offered by 
community organizations, quality measures that engage patients 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 requirements or 
were already reflected in the scope of service elements.
    Response: We appreciate the commenters' concerns about ensuring 
quality of care. We continue to believe that with the addition of the 
EHR element, the required 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 addresses 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 broad 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 continuity of care. Several commenters did not believe 
the proposal would pose a significant administrative 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 insufficient number of 
physicians have adopted CEHRT with the functionalities we proposed for 
CCM, especially interoperability with other providers. The commenters 
were also concerned that physicians 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 was laudable but 
premature, recommending that CMS delay adoption of the 2014 EHR 
certification criteria for CCM services by 3 to 4 years when they 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 provide hardship exceptions for 
certain smaller or rural practices to enable them to bill separately 
for CCM services in the absence of an interoperable EHR in certain 
circumstances, provide 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 
technology if physicians encounter challenges with interoperability. 
Until EHR systems 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 information 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 team, but have not yet fully implemented an 
interoperable EHR with other providers. Several commenters were 
concerned about the ability of current EHR technologies to share 
information 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 prioritize access over adoption of CEHRT. 
Several commenters stated that not all types of physicians have access 
to an EHR that meets the needs of their specialty.
    A number of commenters stated that CCM could be (and already is) 
effectively provided without any EHR or a without a certified EHR, and 
recommended that CMS 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 care 
plan, with some stating that certified EHR systems have not 
demonstrated improvements in the management of chronic conditions, 
especially complex cases, and suggested postponing 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 EHR 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. 
Commenters indicated that many physicians accomplish this through 
generating or receiving electronic discharge summaries, clinical 
documentation, and patient-centered plans of care, but are not using 
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 systems 
were not designed with interoperability in mind and transition costs 
are high. The commenter believed the proposed payment amount would not 
sufficiently cover the cost of purchasing or upgrading an EHR system, 
and requiring a certified EHR would limit the number of eligible 
physicians without significantly adding value to CCM services. Another 
commenter stated that only 1,000 physicians and other eligible health 
professionals have achieved Stage 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 require 
the use of EHR technology that has been certified under the ONC Health 
IT Certification Program as requisite for receiving separate payment 
for CCM services, to ensure that practitioners have adequate 
capabilities to allow members of the interdisciplinary care team to 
have timely access to the most updated information informing the care 
plan. We agree 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 that 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 proposal regarding which

[[Page 67724]]

edition of certified EHR technology will be required, in order to allow 
more flexibility as practitioners transition to the use of certified 
EHR technology. Accordingly, we are 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 Incentive Programs as of December 31st of the calendar year 
preceding each PFS payment year (hereinafter ``CCM certified 
technology'') to meet the final core technology capabilities 
(structured recording of demographics, problems, medications, 
medication allergies, and the creation of a structured 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 are 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 
certification criteria 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 finalizing 
the separate provision we proposed for the electronic care plan scope 
of service element without modification as discussed below. We remind 
stakeholders that for all electronic sharing of beneficiary information 
under our final CCM policies, HIPAA standards apply in the usual 
manner.
    Comment: Several commenters questioned the 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, because many of the Meaningful Use requirements do not 
apply to CCM. Another commenter supported what they understood to be 
our proposal, 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 Meaningful Use criteria, and urged CMS to 
adopt interoperability standards for Meaningful Use that would enable 
successful care coordination models. Another commenter recommended that 
enforcement of the proposed EHR requirement be coterminous with the 
enforcement of Meaningful 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 the EHR scope of 
service element for CCM to be identical, we do not believe that is 
entirely 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 payment 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 the provision of CCM and 
we believe we should only require practitioners to adopt the certified 
technology that is relevant to the scope of CCM services. In their 
attempts to meet Meaningful Use criteria for a given year, 
practitioners are required to use technology certified 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 sufficient for achieving Meaningful Use in that same year because 
CCM must be furnished using at least the edition(s) of certified EHR 
technology required for the EHR Incentive Programs as of December 31st 
of the prior calendar year. Also, it is possible that a practitioner 
could use 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 
measures of a particular stage of Meaningful Use that are required to 
qualify for an EHR Incentive payment or avoid a downward adjustment to 
payments. As the commenters noted, the Meaningful Use measures are not 
all relevant to the provision of CCM services, and the practitioner may 
not have sufficient certified technology to support all the necessary 
or relevant Meaningful Use objectives and measures under the EHR 
Incentive Programs. Certified technology is used in different ways to 
meet the requirements of each program. We believe that the 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 clarify the requirement for 
the electronic care plan in relationship to the overall requirement for 
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 should 
identify objective criteria to evaluate whether a particular health IT 
product has 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 exception to use of CEHRT for the care plan. 
The commenters recommended flexibility in how practitioners and 
providers capture, develop, update and share care plan information. 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 impediments. 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 
treating the patient's chronic conditions, those within the billing 
practice, or those within the billing practice who are communicating 
with the patient after hours. The commenters noted that providers other 
than the billing practitioner may 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 certified EHR 
requirement in relation to the

[[Page 67725]]

electronic care plan, and supported this proposed flexibility.
    Response: Regarding the care plan, we proposed that CCM services 
must be furnished with the use of an EHR or other health IT or health 
information exchange platform (not necessarily a certified EHR) that 
includes an electronic care plan that is accessible at all times to the 
practitioners within the practice, including 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 (who are not billing for CCM). We sought to convey that 
practitioners could satisfy these requirements related to the care plan 
without using the certified EHR technology. We specified that the 
certified EHR technology is only required to accomplish activities 
described in the scope of service elements 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).
    Through separate requirements for the electronic care plan and the 
certified EHR, our intent was to require practitioners to use some form 
of electronic technology tool or service in fulfilling the care plan 
element (other than facsimile transmission), recognizing 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 practice (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 participating in a health information 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 information 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 
furnishing CCM outside of normal business hours. In addition, 
practitioners must electronically share care plan information as 
appropriate with other providers and practitioners who are furnishing 
care to the patient. We are not requiring that practitioners use a 
specific electronic technology to meet the requirement for 24/7 access 
to the care plan or its transmission, only that they use an electronic 
technology other than facsimile. For instance, practices may satisfy 
the 24/7 care plan access requirement through remote access to an EHR, 
web-based access to a care management application, or web-based access 
to a health information exchange service that captures and maintains 
care plan information. Likewise, we are not requiring that 
practitioners 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 may revisit this requirement as standards-based exchange of care 
plan information becomes more widely available in the future. We remind 
stakeholders that for all electronic sharing of beneficiary information 
under our final CCM policies, HIPAA standards apply in the usual 
manner.
    Comment: Several commenters asked us to clarify the relationship 
between the certified EHR proposal and the summary record exchange 
requirement. Commenters believed that CMS had cited specific regulatory 
provisions around exchange in the proposed 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 exchange 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 
transmission 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 practice must be able to facilitate the 
communication of relevant patient information through electronic 
exchange of a summary care record with other health care providers (78 
FR 74418). We did not specify a standard for the ``summary care 
record'' that providers must exchange electronically, nor did we 
specify a method by which providers must facilitate the communication 
of beneficiary information, such as use of certified EHR technology. 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 Coordinator for Health Information 
Technology to an edition of the EHR certification criteria identified 
in the then-applicable version of 45 CFR part 170. Under one of the 
specific certification criteria cited, we proposed that practitioners 
must use technology that meets the criterion adopted at Sec.  
170.314(e)(2), which would ensure that they produce summary records 
formatted according to the standard adopted at Sec.  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 exchange of a summary care 
record, such as the transmission standard related to Direct Project 
Transport in Sec.  170.314(b)(2)(ii). We recognized that providers are 
currently exchanging patient information 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

[[Page 67726]]

edition sets specific requirements for transmission or exchange of the 
summary record that technology must meet for certification, and we 
expected that only some practitioners could adopt and use such 
technology in CY 2015. Therefore we did not constrain practitioners to 
the exchange functionality in the 2014 edition if they utilized an 
alternative electronic tool.
    As discussed above, our final policy will allow practitioners 
billing the PFS for CCM services to use the edition(s) of certification 
criteria that is acceptable for the EHR Incentive Programs as of 
December 31st of each calendar year preceding each PFS payment year to 
meet the final core technology capabilities (structured recording of 
demographics, problems, medications, medication allergies, and the 
creation of a structured clinical summary). (Also practitioners must 
use this CCM certified technology 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 31st 
of the calendar year preceding each PFS payment year.
    We are finalizing our proposal that practitioners must communicate 
relevant patient information through electronic exchange of a summary 
care record to support transitions of care, with a clarification that 
practitioners do not have to use any specific content exchange standard 
in CY 2015. We did not propose and are not finalizing 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 requirement for exchange of the summary care 
record. We did not propose to modify our view, 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 the electronic exchange of beneficiary information in a summary 
care record (78 FR 74418). While certain 2014 edition certification 
criteria address a content standard and transmission method for 
exchange of a summary record, we continue to expect that only some 
practitioners could adopt and use such technology. Moreover, we 
recognize that providers are currently exchanging patient information 
to support transitions of care in a variety of meaningful ways beyond 
the methods specified in 2014 edition certification criteria. We 
continue to believe that at least for CY 2015, we should allow 
flexibility in the selection of the electronic tool or service that is 
used to transmit beneficiary information in support of care 
transitions, as long as practitioners electronically share beneficiary 
information to support transitions of care. Finally we remind 
stakeholders that for all electronic sharing of beneficiary information 
under our final CCM policies, HIPAA standards apply in the usual 
manner.
    Comment: Several commenters expressed concern about requiring a 
certified EHR for billing CCM. The commenters were concerned that CMS 
would not allow the use of non-certified technologies that may be more 
innovative and effective than certified technologies. Commenters 
requested that we clarify whether only the certified EHR (and no other 
electronic tool) could be used to conduct CCM services, for example the 
use of enhanced communication methods other than telephone. One 
commenter stated that many times the practice will be using the 
certified EHR system to carry out such activities, and there 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 support elements of the CCM services. These commenters 
asked us to clarify whether the requirement to utilize certified EHR 
technology is a literal statement that only certified EHR technology 
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 the 
scope of the service a certified EHR that allows for the data capture, 
accessibility and sharing capabilities 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 demographics, problems, medications, 
medication allergies, and the creation of a structured clinical 
summary). In addition, whenever a scope of service element references a 
health or medical record, CCM certified 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 
elements that include a reference to a health or medical record. If 
both CCM certified technology 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 creation of a structured clinical 
summary) or the CCM scope of service elements referencing a the health 
or medical record, practitioners may only use the certified capability. 
We remind stakeholders that for all electronic sharing of beneficiary 
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:
    <bullet> 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.
    <bullet> Patient-Specific Education Resources (Sec.  
170.314(a)(15)), which would help assure the ability to provide the 
patient with relevant educational materials about their chronic disease 
conditions.
    <bullet> Clinical Reconciliation (Sec.  170.314(b)(4)), which would 
serve support the medication reconciliation requirement and the 
requirement to review patient adherence to their medication regime.
    <bullet> View/Download/Transmit to a 3rd Party (Sec.  
170.314(e)(1)), which would enable patients to access their own 
electronic health record and have access to information related to 
their care at their own convenience.
    <bullet> Secure Messaging, Ambulatory Setting Only (Sec.  
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 
requiring the certified technology 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 
certainly help many practitioners fulfill the other elements of the CCM

[[Page 67727]]

service, practitioners may be using tools other than certified 
technology that are adequate for the required task(s), for example, 
registry tools for patient list creation, educational resources, 
patient portals, third party reconciliation services, and secure 
messaging systems.
    Comment: We received many comments on the scope of service elements 
other than the EHR, some requesting that we implement additional 
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 visits 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 recommended additional tools for patient self-management 
education and training, or ``patient activation'' tools. One commenter 
recommended we require a patient experience survey to assess the 
patient's perspective regarding the CCM services they receive. Several 
commenters believed we should expand the medication management and 
medication reconciliation element to include more comprehensive 
medication management and more clearly define ``review of adherence'' 
to the medication regimen.
    Response: Other than the scope of service element for EHR and 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 service in the CY 2014 PFS 
final rule with comment period we are also requiring medication 
reconciliation with review of adherence and potential interactions, and 
oversight of patient self-management of medications. We believe it 
would be overly burdensome, especially given the broad eligible 
beneficiary population and final RVU inputs, to include more specific 
requirements related to medication management, especially when greater 
specificity is likely not necessary to ensure adequate care. The CCM 
services are by definition non-face-to-face services; therefore we are 
not including a requirement for home or domiciliary visits or community 
based care (although there is a requirement related to coordinating 
home and community based care). Practitioners who engage in remote 
monitoring of patient physiological data of eligible beneficiaries may 
count the time they spend reviewing the reported data towards the 
monthly minimum time for billing the CCM code, 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 
into consideration.
    Comment: We received many comments on the scope of service elements 
other than the EHR, requesting that CMS implement fewer standards. 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 adequately document that they have 
fulfilled the requirements. Several commenters did not believe it was 
necessary to require written beneficiary consent. Others asked that CMS 
develop 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 the care plan and clinical summary record will 
create an electronic ``footprint'' that will facilitate documentation, 
including documentation of the minimum monthly amount of time spent in 
providing CCM services.
    Regarding beneficiary consent, we believe written beneficiary 
consent and its documentation in the medical record is necessary 
because we are requiring practices to share beneficiaries' protected 
health information both within and outside of the billing practice in 
the course of furnishing CCM services and because beneficiaries 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 
received 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 of December 31st of the calendar year prior to 
the PFS payment year (CCM certified technology), to meet the final core 
EHR capabilities (structured 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 service elements that reference a health or medical record. 
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 
certification 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:
    <bullet> A full list of problems, medications and medication 
allergies in the EHR must inform the care plan, care coordination and 
ongoing clinical care.
    <bullet> 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.
    <bullet> Inform the beneficiary of the availability of CCM services 
and obtain his or her written agreement to have the services provided, 
including authorization for the electronic communication of his or her 
medical information with other treating 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.
    <bullet> Provide the beneficiary a written or electronic copy of 
the care plan and document in the electronic medical record that the 
care 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, 
practitioners must at least electronically capture care plan 
information; make this information available on a 24/7 basis to all 
practitioners within the practice who are furnishing CCM services whose 
time counts towards the time requirement for the practice to bill the 
CCM code; and share care plan information electronically (other than by 
facsimile) as appropriate with other practitioners

[[Page 67728]]

and providers who are furnishing care to the beneficiary. We are not 
requiring practitioners to use a specific electronic solution to 
furnish the care plan element of the CCM service, only that 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 the exception of faxing which will not fulfill the 
requirement for exchange of a summary care record. 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 31st of the calendar year preceding each PFS payment 
year.
    We remind stakeholders that for all electronic sharing of 
beneficiary information under our final CCM policies, HIPAA standards 
apply in the usual manner. We summarize the final requirements for the 
CCM scope of service elements and billing requirements for CY 2015 and 
their relationship to the final EHR requirements in Table 33.

  Table 33--Summary of Final CCM Scope of Service Elements and Billing
                        Requirements for CY 2015
------------------------------------------------------------------------
                                              Certified EHR or other
  CCM Scope of service element/billing        electronic technology
              requirement                          requirement
------------------------------------------------------------------------
Structured recording of demographics,    Structured recording of
 problems, medications, medication        demographics, problems,
 allergies, and the creation of a         medications, medication
 structured clinical summary record. A    allergies, and creation of
 full list of problems, medications and   structured clinical summary
 medication allergies in the EHR must     records using CCM certified
 inform the care plan, care               technology.
 coordination and ongoing clinical care.
Access to care management services 24/7  None.
 (providing the beneficiary with a
 means to make timely contact with
 health care providers in the practice
 to address his or her urgent chronic
 care needs regardless of the time of
 day or day of the week).
Continuity of care with a designated     None.
 practitioner or member of the care
 team with whom the beneficiary is able
 to get successive routine appointments.
Care management for chronic conditions   None.
 including systematic assessment of the
 beneficiary's medical, functional, and
 psychosocial needs; system-based
 approaches to ensure timely receipt of
 all recommended preventive care
 services; medication reconciliation
 with review of adherence and potential
 interactions; and oversight of
 beneficiary self-management of
 medications.
Creation of a patient-centered care      Must at least electronically
 plan based on a physical, mental,        capture care plan information;
 cognitive, psychosocial, functional      make this information
 and environmental (re)assessment and     available on a 24/7 basis to
 an inventory of resources and            all practitioners within the
 supports; a comprehensive care plan      practice whose time counts
 for all health issues. Share the care    towards the time requirement
 plan as appropriate with other           for the practice to bill the
 practitioners and providers.             CCM code; and share care plan
                                          information electronically
                                          (other than by fax) as
                                          appropriate with other
                                          practitioners and providers.
Provide the beneficiary with a written   Document provision of the care
 or electronic copy of the care plan      plan as required to the
 and document its provision in the        beneficiary in the EHR using
 electronic medical record.               CCM certified technology.
Management of care transitions between   <bullet> Format clinical
 and among health care providers and      summaries according to CCM
 settings, including referrals to other   certified technology.
 clinicians; follow-up after an          <bullet> Not required to use a
 emergency department visit; and follow-  specific tool or service to
 up after discharges from hospitals,      exchange/transmit clinical
 skilled nursing facilities or other      summaries, as long as they are
 health care facilities.                  transmitted electronically
                                          (other than by fax).
Coordination with home and community     Communication to and from home
 based clinical service providers.        and community based providers
                                          regarding the patient's
                                          psychosocial needs and
                                          functional deficits must be
                                          documented in the patient's
                                          medical record using CCM
                                          certified technology.
Enhanced opportunities for the           None.
 beneficiary and any caregiver to
 communicate with the practitioner
 regarding the beneficiary's care
 through not only telephone access, but
 also through the use of secure
 messaging, internet or other
 asynchronous non face-to-face
 consultation methods.
Beneficiary consent--Inform the          Document the beneficiary's
 beneficiary of the availability of CCM   written consent and
 services and obtain his or her written   authorization in the EHR using
 agreement to have the services           CCM certified technology.
 provided, including authorization for
 the electronic communication of his or
 her medical information with other
 treating 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.
Beneficiary consent--Inform the          None.
 beneficiary of the right to stop the
 CCM services at any time (effective at
 the end of the calendar month) and the
 effect of a revocation of the
 agreement on CCM services.
Beneficiary consent--Inform the          None.
 beneficiary that only one practitioner
 can furnish and be paid for these
 services during a calendar month.
------------------------------------------------------------------------


[[Page 67729]]

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-
payer 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 management services furnished to Medicare fee-
for-service beneficiaries attributed 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 purposes of participating in one of these 
initiatives, as we believe the payment for CCM services would be a 
duplicative payment for substantially the same services for which 
payment is made through the per beneficiary per month payment. However, 
we proposed that these practitioners may bill Medicare 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 initiatives. 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 potential overlaps with the CCM service and seek to 
implement appropriate reimbursement 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.
    The following is a summary of the other comments 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 
services to ensure that these practitioners are not disadvantaged 
relative to those practitioners who do not participate in 
demonstrations or models.
    Response: Our proposed policy does not exclude practitioners 
participating in demonstrations or models from billing for CCM 
services. 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 participating in either 
the MAPCP or CPC. For beneficiaries who are not attributed to the 
practice, 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 Medicare 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 participating in CPC or MAPCP to bill Medicare for the 
CCM services, as not all beneficiaries treated in a practice will be 
attributed to the practice.
    Comment: We received two comments expressing concern for confusion 
that might occur regarding the interaction of CCM services and the CPC 
model.
    Response: We acknowledge that the Innovation Center will need to 
engage in extensive communications efforts with practitioners 
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 
be constrained'' by the payment in a demonstration. The commenter also 
said, ``The two payments are completely unrelated and are made for 
different purposes to very different physician practices. Also, we do 
not believe it is possible to know with certainty whether there is 
overlap between a fee[hyphen]for[hyphen]service chronic care management 
payment and a payment for care coordination in a demonstration.''
    Response: The proposed policy aims not to constrain practitioners 
voluntarily participating in Innovation Center models and 
demonstrations, specifically 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 electronic health records that 
have been certified by the National Coordinator for Health Information 
Technology, provide patients with 24/7 access to the practice, ensure 
continuity of care with a designated practitioner or care team for each 
patient, provide care management that includes a systematic assessment 
of patient needs, use patient-centered care plans, and give enhanced 
opportunities for patient and caregiver communications. Similarly, the 
MAPCP demonstration is testing the patient-centered medical home model, 
which focuses on care management, continuity of care, and care 
coordination. All practitioners, who are voluntarily participating in 
these initiatives, receive quarterly reports indicating which 
beneficiaries have been attributed to their practices. After reviewing 
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 provides appropriate payment for care management and care 
coordination furnished to beneficiaries with multiple chronic 
conditions within the current fee-for-service Medicare program, while 
Innovation Center models and demonstrations test alternative payment 
methods that promote less reliance on a fee-for-service funding stream 
and support primary care delivery transformation at the practice level 
to identify potential future alternative approaches to payment.
    In response to these comments, we will engage in extensive 
communications explaining to practices participating in CMMI models and 
demonstrations, specifically the CPC and MAPCP initiatives, the 
policies related to care management payments 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 included 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 potential overlaps with the

[[Page 67730]]

CCM service and seek to implement appropriate payment policies.

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 ``therapy caps.'' There is one 
therapy cap for outpatient occupational therapy (OT) services and 
another separate therapy cap for physical therapy (PT) and speech-
language pathology (SLP) services combined.
    The therapy caps apply to outpatient therapy services furnished in 
all settings, including the once-exempt outpatient hospital setting 
(effective 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). 
Specifically, the annual caps 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 therapy cap of $1,920 by the 
CY 2015 MEI of 0.8 percent and rounding to the nearest $10.00 results 
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 the 
Act, the exceptions process for the therapy caps has been extended 
multiple times through subsequent legislation (MIEA-TRHCA, MMSEA, 
MIPPA, the Affordable Care Act, MMEA, TPTCCA, MCTRJCA, ATRA and PAMA). 
The Agency's current authority to provide an exceptions process for 
therapy caps expires on March 31, 2015.
    After expenses incurred for the beneficiary's outpatient therapy 
services for the year have exceeded one or both of the therapy caps, 
therapy 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 and necessary and that there is 
documentation of medical necessity 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 beneficiary's 
incurred expenses for outpatient therapy services exceed a threshold 
amount of $3,700. There are two separate 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 towards 
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 provide an exceptions process 
for the therapy caps. For information on the manual medical review 
process, go to www.cms.gov/Research-Statistics-Data-and-Systems/Monitoring-Programs/Medical-Review/TherapyCap.html.

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 other things, section 1861(pp)(1)(D) of 
the Act authorizes the Secretary to modify the tests and procedures 
covered under this subsection, ``with such frequency and payment 
limits, as the Secretary determines appropriate,'' in consultation with 
appropriate organizations. The current definition of ``colorectal 
cancer screening tests'' at Sec.  410.37(a)(1) includes ``screening 
colonoscopies.'' Until recently, the prevailing practice for screening 
colonoscopies has been moderate sedation provided intravenously by the 
endoscopist, without resort to separately 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). For these procedures, 
because moderate sedation is bundled into the payment, the same 
physician cannot also report a sedation code. An anesthesia service can 
be billed by a second physician.
---------------------------------------------------------------------------

    \3\ Faulx, A. L. et al. (2005). The changing landscape of 
practice patterns regarding unsedated colonoscopy and propofol use: 
A national web survey. Gastrointestinal Endoscopy, 62. 9-15.
---------------------------------------------------------------------------

    However, a recent study in The Journal of the American Medical 
Association (JAMA) cited an increase in the percentage of colonoscopies 
and upper endoscopy procedures furnished using an anesthesia 
professional, from 13.5 percent in 2003 to 30.2 percent in 2009 within 
the Medicare population, with a similar increase in the commercially-
insured population.\4\ A 2010 study projected that the percentage of 
this class of procedures involving an anesthesia professional would 
grow to 53.4 percent by 2015.\5\ These studies suggest that the 
prevailing practice for endoscopies in general and screening 
colonoscopies in particular is undergoing a transition, and that 
anesthesia separately provided by an anesthesia professional is 
becoming the prevalent practice. In preparation for the proposed rule, 
we reviewed these studies and analyzed Medicare claims data. We saw the 
same trend in screening colonoscopies for Medicare beneficiaries with 
53 percent of the screening colonoscopies for Medicare claims submitted 
in 2013 had a separate anesthesia claim reported.
---------------------------------------------------------------------------

    \4\ Liu H, Waxman DA, Main R, Mattke S. Utilization of 
Anesthesia Services during Outpatient Endoscopies and Colonoscopies 
and Associated Spending in 2003-2009. (2012). JAMA, 307(11):1178-
1184.
    \5\ Inadomi, J. M. et al. (2010). Projected increased growth 
rate of anesthesia professional-delivered sedation for colonoscopy 
and EGD in the United States: 2009 to 2015. Gastrointestinal 
Endoscopy, 72, 580-586.
---------------------------------------------------------------------------

    In light of these developments, we expressed 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 were convinced that the growing prevalence of 
separately provided anesthesia services in conjunction with screening 
colonoscopies reflects a change in practice patterns. Therefore, 
consistent with the authority delegated by section 1861(pp)(1)(D) of 
the Act, we proposed to revise the definition of ``colorectal cancer 
screening tests'' to adequately reflect these new patterns. 
Specifically, we proposed to revise the definition of ``colorectal 
cancer screening tests'' at Sec.  410.37(a)(1)(iii) to include 
anesthesia that is separately furnished in conjunction with screening 
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 beneficiaries' cost-sharing obligations under Part B. 
Screening colonoscopies have been recommended with a grade of A by the 
United States Preventive Services Task Force (USPSTF) and Sec.  
410.152(l)(5) provides that Medicare Part B pays 100 percent of the 
Medicare payment amount established under the PFS for colorectal cancer 
screening tests except for barium enemas (which do not have a grade A 
or B recommendation from the USPSTF). This regulation is based on 
section 1833(a)(1) of the Act, as amended by section 4104 of the 
Affordable Care Act, which requires 100

[[Page 67731]]

percent Medicare payment of the fee schedule amount for those 
``preventive services'' that are appropriate for the individual and are 
recommended with a grade of A or B by the USPSTF. Section 4104 of the 
Affordable Care Act amended section 1833(a)(1) of the Act to 
effectively waive any Part B coinsurance that would otherwise 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 rulemaking based on this 
provision see the CY 2011 PFS final rule with comment period (75 FR 
73412 through 73431). We also noted that under Sec.  410.160(b)(7) 
colorectal cancer screening tests are not subject to the Part B annual 
deductible and do not count toward meeting that deductible.
    In implementing the amendments made by section 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 screening colonoscopies. At 
that time, we believed that our payment for the screening colonoscopy, 
which included payment for moderate sedation services, reflected the 
typical screening colonoscopy. Under the current regulations, Medicare 
beneficiaries who receive anesthesia from a different professional than 
the one furnishing the screening colonoscopy would be incurring costs 
for the coinsurance and deductible under Part B for those separate 
services. With the changes in the standard of care and shifting 
practice patterns toward increased use of anesthesia in conjunction 
with screening colonoscopy, beneficiaries who receive covered 
anesthesia services from a different professional than the one 
furnishing the colonoscopy would incur costs for any coinsurance 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 colonoscopies, including any portion 
attributable to anesthesia services furnished by a separate 
practitioner in conjunction with such tests, under Sec.  410.152(l)(5). 
Similarly, this revision would also mean that expenses incurred for a 
screening colonoscopy, and the anesthesia services furnished in 
conjunction with such tests, will not be subject to the Part B 
deductible and will not count toward meeting that deductible under 
Sec.  410.160(b)(7). We believe the proposal encourages more 
beneficiaries to obtain a screening colonoscopy, which is consistent 
with the intent of the statutory provision to waive Medicare cost-
sharing for certain recommended preventive services, and is consistent 
with the authority delegated to the Secretary in section 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 
deductible and coinsurance expenses for separately billed anesthesia 
services furnished and covered by Medicare in conjunction with 
screening colonoscopies could become a significant barrier to these 
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 these provisions 
was to eliminate financial barriers so that beneficiaries would not be 
deterred from receiving them (75 FR 73412). Therefore, we proposed to 
exercise 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 deductible to anesthesia or sedation services furnished 
in conjunction 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 other codes that include moderate 
sedation, as discussed 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 strongly supported finalizing 
our proposal to revise the definition of ``colorectal cancer screening 
tests'' at Sec.  410.37(a)(1)(iii) to include anesthesia that is 
furnished in conjunction with screening colonoscopies. However, one 
commenter expressed concern about the timing of the proposal, and 
specifically that it leaves little time for implementation in CY 2015. 
Therefore, the commenter recommended that the proposal should be 
considered for implementation in CY 2016.
    Response: We appreciate the support for our proposal and are 
finalizing it as proposed. Specifically, we are revising the definition 
of ``colorectal cancer screening tests'' at Sec.  410.37(a)(1)(iii) to 
include anesthesia that is furnished in conjunction with screening 
colonoscopies. We disagree with the recommendation to delay 
implementation until CY 2016. The proposed implementation on January 
1st 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 schedule for this 
policy. Therefore, we are implementing this final rule, effective 
January 1, 2015.
    Comment: Many commenters urged us to extend our proposed revision, 
by identifying a way under our existing authority to redefine 
colorectal cancer screening to include screening colonoscopy with 
removal of polyp, abnormal growth, or tissue during the screening 
encounter. Commenters stated that there is already substantial 
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 
include anesthesia that is separately furnished in conjunction with 
screening colonoscopies within the definition of screening colonoscopy 
would only cause additional confusion, unless screening colonoscopies 
with removal of polyp, along with any anesthesia separately furnished 
in conjunction with such procedures, are also included within 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 extending our proposal in this manner would be good 
public policy, because it would reduce 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

[[Page 67732]]

also emphasized that further extending the definition in this way would 
remove an inconsistency between Medicare policy and the new 
requirements for private health plans that prohibit the imposition of 
cost 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 recommended 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 not be made for the screening 
colonoscopy but shall be made for the procedure classified as a 
colonoscopy with such biopsy or removal.'' As a result of this 
statutory provision, when an anticipated screening colonoscopy ends up 
involving a biopsy or polyp removal, Medicare cannot pay for this 
procedure as a screening colonoscopy. In these circumstances, Medicare 
pays 80 percent of the diagnostic colonoscopy procedure and the 
beneficiary is responsible for paying Part B coinsurance. Under the 
statute, when a polyp or other growth is removed, beneficiaries are 
responsible for Part B coinsurance for the diagnostic colonoscopy, and 
similarly, any Part B coinsurance for any covered anesthesia.
    Comment: Commenters stated that the proposal 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 Act, as amended by section 
4104(c) of the Affordable Care Act, waives the Part B deductible for 
``colorectal screening tests regardless of the code billed for the 
establishment of a diagnosis as a result of the test, or the removal of 
tissue or other matter or other procedure that is furnished in 
connection with, as a result of, and in the same 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 colorectal 
cancer screening test. Our regulations at Sec.  410.152(l)(5) already 
require Medicare Part B to pay 100 percent of the Medicare payment 
amount for colorectal cancer screening tests (excluding barium enema). 
The statutory waiver of deductible will apply to the anesthesia 
services furnished in conjunction with a colorectal cancer screening 
test even when a polyp or other tissue is removed during 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 provide 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 indicate whether the procedure was screening or not.
    Response: Effective January 1, 2015, beneficiary coinsurance and 
deductible do not apply to the following anesthesia claim lines billed 
when furnished in conjunction with screening colonoscopy services and 
billed with the appropriate modifier (33): 00810 (Anesthesia for lower 
intestinal endoscopic procedures, endoscope introduced distal to 
duodenum). Anesthesia professionals who furnish a separately payable 
anesthesia service in conjunction with a colorectal cancer screening 
test should include the 33 modifier on the claim line with the 
anesthesia service. As noted above in situations that begin as a 
colorectal cancer screening test, but for which another service such as 
colonoscopy with polyp removal is actually furnished, the anesthesia 
professional should report a PT modifier on the claim line rather than 
the 33 modifier.
    Comment: Several commenters recommended that we not only finalize 
the revised definition of ``colorectal cancer screening tests,'' but 
also take steps to ensure that our Medicare Administrative Contractors 
(MACs) are not inappropriately taking actions that have the effect of 
nullifying some or much of the intended benefit 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. Another commenter urged us to clarify that 
this proposed expanded definition of colorectal cancer screening to 
include anesthesia services should 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 national 
policy and takes precedence over any local coverage policy that limits 
Medicare coverage for anesthesia services furnished during a screening 
colonoscopy by an anesthesia professional.

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 furnished. Under ``unusual circumstances,'' physicians 
can bill for a secondary interpretation using modifier -77, for 
instance, when an emergency room physician conducts an x-ray, provides 
an interpretation, identified a questionable finding, and subsequently 
requests a second interpretation from a radiologist to inform treatment 
decisions. In all cases, a ``professional component'' (PC) 
interpretation service should only be billed for a full interpretation 
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, 
growth in image sharing networks and health information exchange 
platforms through which providers can share images, and consumer-
mediated exchange of images, have greatly increased physicians' access 
to existing diagnostic-quality radiology images. Accessing and 
utilizing 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 appropriateness of more routine 
billing for secondary interpretations, although we did not propose to 
make any changes to the 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 incidence of duplicative advanced imaging studies.
    To achieve that goal, we solicited comments on the following: the 
circumstances under which physicians are currently conducting secondary 
interpretations and whether they are seeking payment for these 
interpretations; whether more routine payment for secondary 
interpretations should be restricted to certain high-cost advanced 
diagnostic imaging services; considerations for valuing secondary 
interpretation services; the settings in which secondary 
interpretations chiefly occur; and considerations for

[[Page 67733]]

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 interpretation 
solicitation. In addition to comments on the merits of the proposals, 
commenters also provided helpful information about how to implement 
this policy. Commenters offered diverse opinions on the time period for 
which an existing image would 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 interpretation 
policy but there was no consensus as to the amount of such savings. 
Moreover, many commenters pointed out that they were already furnishing 
secondary interpretations and would appreciate adoption of a policy 
that would allow them to receive payment for these services.
    Response: We thank all the commenters for 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.

L. Conditions Regarding Permissible Practice Types for Therapists in 
Private Practice

    Section 1861(p) of the Act defines outpatient therapy services to 
include physical therapy (PT), occupational therapy (OT), and speech-
language pathology (SLP) services furnished by qualified occupational 
therapists, physical therapists, and speech-language pathologists in 
their offices and in the homes of beneficiaries. The regulations at 
Sec. Sec.  410.59(c), 410.60(c), and 410.62(c) set forth special 
provisions for services furnished by therapists in private practice, 
including basic qualifications necessary to qualify as a supplier of 
OT, PT, and SLP services, respectively. As part of these basic 
qualifications, the current regulatory language includes descriptions 
of the various practice types for therapists' private practices. Based 
on our review of these three sections of our regulations, we became 
concerned that the language is not as clear as it could be--especially 
with regard to the relevance of whether a practice is incorporated. The 
regulations appear to make distinctions between unincorporated and 
incorporated practices, and some practice types are listed twice. 
Accordingly, we proposed changes to the regulatory language to remove 
unnecessary distinctions and redundancies within the regulations for 
OT, PT, and SLP. We noted that these changes are for clarification 
only, and do not reflect any change in our current policy.
    To consistently specify the permissible practice types (a solo 
practice, partnership, or group practice; or as an employee of one of 
these) for suppliers of outpatient therapy services in private practice 
(specifically for occupational therapists, physical therapists and 
speech-language pathologists), we proposed to replace the regulatory 
text at Sec.  410.59(c)(1)(ii)(A) through (E), Sec.  
410.60(c)(1)(ii)(A) through (E), and Sec.  410.62(c)(1)(ii)(A) through 
(E) and to replace it with language listing the permissible practice 
types without limitations for incorporated or unincorporated.
    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 clarifying 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 practice to be employed 
by physician groups as specified in current provisions.
    Response: We appreciate the commenters' support for our proposal. 
With regard to the commenter that expressed concern about the clarity 
of the proposed regulation text as to whether therapists in private 
practice can be employed by a physician group, we acknowledge that the 
current regulation explicitly permits that practice arrangement. 
However, we believe that our proposed language describing the practice 
arrangements of private practice therapists-a solo practice, 
partnership, or group practice; 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 regulation to ``group practice'' is sufficiently broad 
to encompass a physician group, and thus permits therapists in private 
practice to practice as employees of these groups, where permissible 
under state law.
    Therefore, we are finalizing our proposed changes to the 
regulations for permissible practice types for therapists in private 
practice at Sec.  410.59(c)(1)(ii)(A) through (E), Sec.  
410.60(c)(1)(ii)(A) through (E), and Sec.  410.62(c)(1)(ii)(A) 
through(E).

M. Payments for Practitioners Managing Patients on Home Dialysis

    In the CY 2005 PFS final rule with comment period (69 FR 66357 
through 66359), we established criteria for furnishing outpatient per 
diem ESRD-related 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-related services would 
not be paid for under the monthly capitation payment (MCP), and that 
use of the per diem services is limited to the circumstances listed 
below.
    <bullet> Transient patients--Patients traveling away from home 
(less than full month);
    <bullet> Home dialysis patients (less than full month);
    <bullet> 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.
    <bullet> Patients who have a permanent change in their MCP 
physician during the month.
    Additionally, we provided billing guidelines for 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 complete assessment of the 
ESRD beneficiary, the MCP practitioner should bill for the full MCP 
service that reflects the number of visits furnished during the month. 
However, we did 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 comment 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, we 
inadvertently did not modify our billing guidelines for home dialysis 
(less than a full month) to be consistent with partial month scenarios 
for center-based dialysis patients. As discussed in the CY

[[Page 67734]]

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 age 
appropriate home dialysis MCP service (as described by HCPCS codes 
90963 through 90966) for the home dialysis (less than a full month) 
scenario if the MCP practitioner furnishes a complete monthly 
assessment 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 change to home dialysis (less than a full month) would provide 
consistency with our policy for partial month scenarios pertaining to 
patients dialyzing in a dialysis center. We also stated that if this 
proposal is adopted, we would modify the Medicare Claims Processing 
Manual to reflect 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 proposed 
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 necessary to appropriately align 
practitioner payment for managing home dialysis patients with center 
based patients, and encouraged us to finalize the change in policy as 
proposed. One commenter explained that the current policy for home 
dialysis less than a full month requires the nephrologist 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 ``properly aligning 
physician payments for managing home dialysis patients (with managing 
center based dialysis patients) may enable more patients to consider 
dialyzing at home, when appropriate.''
    Response: We agree with the commenters and will finalize our 
proposed policy change for home dialysis. We will allow the MCP 
practitioner to bill for 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 beneficiary and at 
least one face-to-face patient visit during the month.

N. Allowed Expenditures for Physicians' Services and the Sustainable 
Growth Rate

1. Medicare Sustainable Growth Rate (SGR)
    The SGR is an annual growth rate that applies to physicians' 
services paid by Medicare. The use of the SGR is intended to control 
growth in aggregate Medicare expenditures for physicians' services. 
Payments for services are not withheld 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 based on a 
comparison of allowed expenditures (determined using the SGR) and 
actual expenditures. If actual expenditures exceed allowed 
expenditures, the update is reduced. If actual expenditures are less 
than allowed expenditures, the update is increased.
    Section 1848(f)(2) of the Act specifies 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 average number of Medicare fee-for-
service beneficiaries;
    (3) The estimated projected growth in real Gross Domestic Product 
per capita; and
    (4) The estimated change in expenditures due to changes in statute 
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). Under section 1848(f)(3)(C)(ii) of the Act, there are no 
further revisions to the SGR once it has been estimated and 
subsequently revised in each of the 2 years following the preliminary 
estimate. In this final rule with comment, we are 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 Act 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 diagnostic laboratory tests and radiology services), specified 
by the Secretary, that are commonly performed or furnished by a 
physician 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 listed in section 1861(s) of the Act. Since that time, the 
statute has been amended to add new Medicare 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 
criteria specified in section 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 discretion to 
decide whether physician-administered drugs should be included or 
excluded from the definition of ``physicians' services.'' Exercising 
this discretion, we removed physician-administered 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 fully the 
Secretary's policy decision to remove drugs from the definition of 
physicians' services, we removed physician-administered drugs from the 
calculation of allowed and actual expenditures for all prior years.
    Thus, for purposes of determining allowed expenditures, actual 
expenditures for all years, and SGRs beginning with CY 2010 and for all 
subsequent years, we specified that physicians' services include the 
following medical and other health services if bills for the items and 
services are processed and paid by Medicare carriers (and those paid 
through intermediaries where specified) or the equivalent services 
processed by the Medicare Administrative Contractors:
    <bullet> Physicians' services.
    <bullet> Services and supplies furnished incident to physicians' 
services, except for the expenditures for ``drugs and biologicals which 
are not usually self-administered by the patient.''
    <bullet> Outpatient physical therapy services and outpatient 
occupational therapy services,

[[Page 67735]]

    <bullet> Services of PAs, certified registered nurse anesthetists, 
certified nurse midwives, clinical psychologists, clinical social 
workers, nurse practitioners, and certified nurse specialists.
    <bullet> Screening tests for prostate cancer, colorectal cancer, 
and glaucoma.
    <bullet> Screening mammography, screening pap smears, and screening 
pelvic exams.
    <bullet> Diabetes outpatient self-management training (DSMT) 
services.
    <bullet> Medical Nutrition Therapy (MNT) services.
    <bullet> Diagnostic x-ray tests, diagnostic laboratory tests, and 
other diagnostic tests (including outpatient diagnostic laboratory 
tests paid through intermediaries).
    <bullet> X-ray, radium, and radioactive isotope therapy.
    <bullet> Surgical dressings, splints, casts, and other devices used 
for the reduction of fractures and dislocations.
    <bullet> Bone mass measurements.
    <bullet> An initial preventive physical exam.
    <bullet> Cardiovascular screening blood tests.
    <bullet> Diabetes screening tests.
    <bullet> Telehealth services.
    <bullet> Physician work and resources to establish and document the 
need for a power mobility device.
    <bullet> Additional preventive services.
    <bullet> Pulmonary rehabilitation.
    <bullet> Cardiac rehabilitation.
    <bullet> Intensive cardiac rehabilitation.
    <bullet> Kidney disease education (KDE) services.
    <bullet> Personalized prevention plan services
b. Preliminary Estimate of the SGR for 2015
    We first estimated the CY 2015 SGR in March 2014, and we made the 
estimate available to the MedPAC and on our Web site. Table 34 shows 
the March 2014 estimate and our current estimates of the factors 
included in the 2015 SGR. Our March 2014 estimate of the SGR was -3.6 
percent. Our current estimate of the 2015 SGR is -13.7 percent. The 
majority of the difference between the March estimate and our current 
estimate of the CY 2015 SGR is explained by adjustments to reflect 
intervening legislative changes that occurred after our March estimate 
was prepared. Subsequent to the display 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 percent reduction that would have 
occurred under the SGR system on April 1, 2014. In addition, section 
101 of PAMA also provides for a 0.0 percent update for services 
furnished on or after 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 result of the expiration of the temporary 0.0 percent 
update. The law and regulation factor of the current 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 Calculation
------------------------------------------------------------------------
        Statutory factors           March estimate     Current estimate
------------------------------------------------------------------------
Fees............................  1.1 percent         0.7 percent
                                   (1.011).            (1.007).
Enrollment......................  4.0 percent         3.9 percent
                                   (1.040).            (1.039).
Real Per Capita GDP.............  0.8 percent         0.7 percent
                                   (1.008).            (1.007).
Law and Regulation..............  -9.0 percent        -18.1 percent
                                   (0.910).            (0.819).
------------------------------------------------------------------------
    Total.......................  -3.6 percent        -13.7 percent
                                   (0.964).            (0.863).
------------------------------------------------------------------------
Note: Consistent with section 1848(f)(2) of the Act, 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 Growth 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, which 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 legislative 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 resulted 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.

                    Table 35--CY 2014 SGR Calculation
------------------------------------------------------------------------
                                   Estimate from CY
        Statutory factors           2014 final rule    Current estimate
------------------------------------------------------------------------
Fees............................  0.6 percent         0.7 Percent
                                   (1.006).            (1.007).
Enrollment......................  2.2 percent         0.2 Percent
                                   (1.022).            (1.002).
Real Per Capita GDP.............  0.8 percent         0.7 Percent
                                   (1.008).            (1.007).
Law and Regulation..............  -19.6 percent       -2.4 Percent
                                   (0.804).            (0.976).
------------------------------------------------------------------------
    Total.......................  -16.7 percent       -0.8 Percent
                                   (0.833).            (0.992).
------------------------------------------------------------------------
Note: Consistent with section 1848(f)(2) of the Act, the 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 explanation of
  each figure is provided in section II.N.1.e. of this final rule with
  comment period.


[[Page 67736]]

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 figures 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
----------------------------------------------------------------------------------------------------------------
                                        Estimate from CY 2013    Estimate from CY 2014
          Statutory factors                   final rule               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, the 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 between 
these estimates and the actual measurement of these figures will be 
included in future revisions of the SGR and allowed expenditures and 
incorporated into subsequent PFS updates.
(a) Factor 1--Changes in Fees for Physicians' 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 
definition of physicians' services for the SGR. Medical and other 
health services paid using the PFS are estimated to account for 
approximately 89.6 percent of total allowed charges included in the SGR 
in CY 2015 and are updated using the percent change in the MEI. As 
discussed in section A of this final rule with comment period, the 
percent change in the MEI for CY 2015 is 0.8 percent. Diagnostic 
laboratory tests are estimated to represent approximately 10.4 percent 
of Medicare allowed charges 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 percent for CY 2015. Section 
1833(h)(2)(A)(iv) of the 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). The MFP adjustment 
will not apply in a year where the CPI-U is zero or a percentage 
decrease. Further, the application of the MFP adjustment shall not 
result in an adjustment to the fee schedule of less than zero for a 
year. However, the application of the percentage adjustment may result 
in an adjustment to the fee schedule being less than zero for a year 
and may result in payment rates for a year being less than such payment 
rates for the preceding year. The applicable productivity 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)) update for CY 2015. Additionally, 
the percentage reduction of 1.75 percent is applied for CYs 2011 
through 2015, as discussed previously. Therefore, for CY 2015, 
diagnostic laboratory tests will 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 MEI 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 increase in fees for 
physicians' services in CY 2015 under the SGR (before applying any 
legislative adjustments) will be 0.7 percent.
(b) Factor 2--Percentage Change in the Average 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 enrollees 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 Beneficiaries 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 enrollment in MA plans will compare 
to current estimates. For this reason, the estimate may change 
substantially as actual Medicare fee-for-service enrollment for CY 2015 
becomes known.
(c) Factor 3--Estimated Real Gross Domestic 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 growth in the 10-year 
moving average 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 
change in real

[[Page 67737]]

GDP per capita growth computed after the year is complete. 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 expenditures of -18.1 percent. This is primarily due to 
payment reductions for eligible professionals that are not 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 
expiration of the work GPCI floor.
(2) Detail on the CY 2014 SGR
    A more detailed discussion of our revised estimates of the four 
elements of the CY 2014 SGR follows.
(a) Factor 1--Changes in Fees for Physicians' 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 
approximately 91.1 percent of total allowed charges included in the SGR 
in CY 2014. These services were updated using the CY 2014 percent 
change in the MEI of 0.8 percent. We estimate that diagnostic 
laboratory tests represent approximately 8.9 percent of total allowed 
charges included in the SGR in CY 2014. For CY 2014, diagnostic 
laboratory tests received an update of -0.8 percent.
    Table 39 shows the weighted-average of the 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 described in Table 39, we estimate 
that the weighted-average increase in fees for physicians' services in 
CY 2014 under the SGR was 0.7 percent. Our estimate of this factor in 
the CY 2014 PFS final rule with comment period was 0.6 percent (78 FR 
74393).
(b) Factor 2--Percentage Change in the Average Number of Part B 
Enrollees from CY 2013 to CY 2014
    We estimate that the average number of Medicare 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 percent.
------------------------------------------------------------------------

    Our estimate of the 0.2 percent change in the number of fee-for-
service enrollees, net of Medicare Advantage enrollment for CY 2014 
compared 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 had no actual 
data, it is still possible 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 moving 
average of real GDP per capita (2005 through 2014)). Our past 
experience indicates that there have also been differences between our 
estimates of real per capita GDP growth made prior to the year's end 
and the actual change in this factor. Thus, it is possible that this 
figure will change further as complete actual information on CY 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 
expenditures of -2.4 percent. This impact is due to many different 
legislative or regulatory provisions 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 revised estimates of the 
four elements of the CY 2013 SGR follows.
(a) Factor 1--Changes in Fees for Physicians' Services for CY 2013
    This factor was calculated as a weighted average 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 
approximately 90.1 percent of total allowed charges included in the SGR 
in CY 2013. These services 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 percent of total allowed 
charges included in the SGR in CY 2013. For CY 2013, diagnostic 
laboratory tests received an update of -3.0 percent.
    Table 41 shows the weighted-average of the 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 described in Table 41, we estimate 
that the weighted-average increase in fees for physicians' services in 
CY 2013 under the SGR (before applying any legislative adjustments) was 
0.4 percent. This figure is a final one based on complete data for CY 
2013.

[[Page 67738]]

(b) Factor 2--Percentage Change in the Average Number 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 illustrates the calculation of this factor.

  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-year 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 expenditures from the 
statutory and regulatory provisions that affect expenditures in CY 2013 
relative to CY 2012 is -0.5 percent. This impact is due to many 
different legislative or regulatory provisions affecting spending in 
2013 relative to 2012, including provisions of the American Taxpayer 
Relief Act in 2013.
2. The Update Adjustment Factor (UAF)
    Section 1848(d) of the Act provides that the PFS update is equal to 
the product of the MEI and the UAF. The UAF is applied to make actual 
and target expenditures (referred to in the statute as ``allowed 
expenditures'') equal. As discussed previously, allowed expenditures 
are equal to actual expenditures in a base period updated 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 note 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. 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 Human 
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 payment rates under such title XVIII.'' 
Therefore, allowed charges, which are unaffected by sequestration, were 
used to calculate physician expenditures in lieu of Medicare payments 
plus beneficiary cost-sharing. 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, the UAF for a year 
beginning with CY 2001 is equal to the sum of the following--
    <bullet> Prior Year Adjustment Component. An amount determined by--
    ++ Computing the difference (which may be positive or negative) 
between the amount of the allowed expenditures for physicians' services 
for the prior year (the year prior to the year for which the update is 
being determined) and the 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.
    <bullet> Cumulative Adjustment Component. An amount determined by--
    ++ Computing the difference (which may be positive or negative) 
between the amount of the allowed expenditures for physicians' services 
from April 1, 1996, through the end of the prior year and the amount of 
the actual expenditures for those services during that period;
    ++ Dividing that difference by actual expenditures for those 
services for the prior year as increased by the SGR for the year for 
which 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 section 1848(f)(3) of 
the Act. As discussed previously, section 1848(f)(3) specifies that the 
SGR (and, in turn, 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 generally are estimated initially and subsequently revised 
twice. The second revision occurs after the CY has ended (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 corresponding to each period 
through CY 2015.

[[Page 67739]]

[GRAPHIC] [TIFF OMITTED] TR13NO14.059

    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 
expenditures 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 allowed expenditures. Because we have incomplete actual 
expenditure data for CY 2014, we are using an estimate for this period. 
Any difference between 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:

[[Page 67740]]

[GRAPHIC] [TIFF OMITTED] TR13NO14.060

    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 the extent that the 
Secretary finds, on the basis 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 reclassified certain cost categories, 
price proxies, and expense categories.
    The MEI measures the weighted-average annual price change for 
various inputs needed to produce physicians' services. The MEI is a 
fixed-weight input price index, 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 categories: (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 salaries; and (2) fringe benefits.
    The physician's practice expense (PE) category represents 
nonphysician inputs used in the production of services in physicians' 
offices. This category consists of wages and salaries and fringe 
benefits for nonphysician staff (who cannot bill independently) and 
other nonlabor inputs. The physician's PE component 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 
percent increase in physician's own time and a 1.5 percent increase in 
physician's PE. Within the physician's PE, the largest increase 
occurred in postage, which increased 5.4 percent.
    For CY 2015, the increase in the MEI is 0.8 percent, which reflects 
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 average 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.

Table 44--Increase in the Medicare Economic Index Update for CY 2015 \1\
------------------------------------------------------------------------
                                      2006 revised cost
       Revised cost category          weight (percent)     CY15  update
                                             \2\            (percent)
------------------------------------------------------------------------
MEI Total, productivity adjusted...            100.000              0.8
Productivity: 10-year moving                   \5\ N/A              0.9
 average of MFP \1\................

[[Page 67741]]

 
MEI Total, without productivity                100.000              1.7
 adjustment........................
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                7.249              2.0
         wages.....................
        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                4.636              1.5
     wages.........................
    Non-physician benefits.........              4.668              1.9
    Other Practice Expense.........             32.581              1.4
        Utilities..................              1.266              4.0
        Miscellaneous Office                     2.478              1.0
         Expenses..................
        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,                2.592              1.8
         and Tech. Services........
        Administrative and support               3.052              1.9
         & waste...................
        All Other Services.........              2.451              1.2
    Capital........................             10.310              1.8
        Fixed......................              8.957              1.9
        Moveable...................              1.353              0.8
    Professional Liability                       4.295             -0.1
     Insurance \4\.................
    Medical Equipment..............              1.978             -0.3
    Medical supplies...............              1.760             -0.2
------------------------------------------------------------------------
\1\ The forecasts are based upon the latest available Bureau of Labor
  Statistics 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 physicians' services for CY 2006. To determine the MEI level
  for a given year, the price proxy 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 basket 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 December 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 April 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 less productivity times the UAF, which 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 calculated 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 Improvements and Extension Act, 
Division B of the Tax Relief and Health Care Act of 2006 (MIEA-TRHCA) 
provided a 1-year 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, 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 increase 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 subsequent years must be computed as if 
the increases for CYs 2007, 2008, and 2009 had never applied.
    Section 1011(a) of the DODAA and section 5 of the TEA specified a 
zero

[[Page 67742]]

percent update for CY 2010, effective January 1, 2010 through March 31, 
2010.
    Section 4 of the Continuing Extension Act of 2010 (CEA) extended 
the zero percent update for CY 2010 through May 31, 2010.
    Subsequently, section 101(a)(2) of the PACMBPRA provided for a 2.2 
percent update to the CF, effective from June 1, 2010 to November 30, 
2010.
    Section 2 of the Physician Payment and Therapy Relief Act of 2010 
(Pub. L. 111-286) extended the 2.2 percent update through the end of CY 
2010.
    Section 101 of the MMEA provided a zero percent 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 Tax Cut Continuation Act of 
2011 (TPTCCA) provided a zero percent update effective 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 Relief and Job Creation Act of 
2012 (Job Creation Act) provided a zero percent update effective March 
1, 2012 through December 31, 2012, and 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 Relief 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 years had not been applied.
    Section 1101 of the Pathway for SGR Reform 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 Protecting Access to Medicare Act of 2014 (Pub. 
L. 113-93) (PAMA) extended this 0.5 percent update through December 31, 
2014. Section 101 of the PAMA also provides a 0.0 percent update for 
services furnished on or after 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 years 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 RVUs 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 adjustments 
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. Accordingly, we are decreasing the CF by 0.06 percent 
to offset this estimated increase in Medicare 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 applying 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 comment period announces a reduction to payment rates for 
physicians' services of 21.2 percent during this time period in CY 2015 
under the SGR formula.
    By law, we are required to make these reductions in accordance with 
section 1848(d) and (f) of the Act, and these reductions can only be 
averted by an Act of Congress. While Congress has provided temporary 
relief from these reductions 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 the stability and adequacy of payments from Medicare under 
the PFS.
    We illustrate the calculation of the CY 2015 PFS CF in Table 45.

               Table 45--Calculation of the CY 2015 PFS CF
------------------------------------------------------------------------
 
------------------------------------------------------------------------
                 January 1, 2015 through March 31, 2015
------------------------------------------------------------------------
Conversion Factor in effect in CY   ....................        $35.8228
 2014.
Update............................  0.0 percent (1.00)..
CY 2015 RVU Budget Neutrality       -0.06 percent
 Adjustment.                         (0.9994).
CY 2015 Conversion Factor (1/1/     ....................        $35.8013
 2015 through 3/31/2015).
------------------------------------------------------------------------
                 April 1, 2015 through December 31, 2015
------------------------------------------------------------------------
Conversion Factor in effect in CY   ....................        $35.8228
 2014.
CY 2014 Conversion Factor had       ....................        $27.2006
 statutory increases not applied.
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       -0.06 percent
 Adjustment.                         (0.9994).
CY 2015 Conversion Factor (4/1/     ....................        $28.2239
 2015 through 12/31/2015).
Percent Change in Conversion        ....................          -21.2%
 Factor on 4/1/2015 (relative to
 the CY 2014 CF).
Percent Change in Update (without   ....................          -20.9%
 budget neutrality adjustment) on
 4/1/2015 (relative to the CY 2014
 CF).
------------------------------------------------------------------------

    We note payment for services under the PFS will be calculated as 
follows:

Payment = [(Work RVU x Work GPCI) + (PE RVU x PE GPCI) + (Malpractice 
RVU x Malpractice GPCI)] x CF.
b. Anesthesia Conversion 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 simulate changes to RVUs. More 
specifically, if there is an adjustment to the work, PE, or malpractice 
RVUs, these adjustments are applied to the respective shares of the 
anesthesia CF as

[[Page 67743]]

these shares are proxies for the work, PE, and malpractice RVUs for 
anesthesia services. Information regarding the anesthesia work, PE, and 
malpractice shares can be found at the following: https://www.cms.gov/center/anesth.asp.
    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 through 
March 31, 2015. After applying the 0.9994 budget neutrality factor 
described above, the anesthesia 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 that 
are specific to anesthesia. In order to calculate the CY 2015 
anesthesia CF for April 1, 2015 through December 31, 2015, the statute 
requires us to calculate the CFs for all previous years as if the 
various legislative changes to the CFs for those years had not 
occurred. The resulting CF is then adjusted for the update (the MEI, 
less multi-factor productivity and increased by the 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 have RVUs. Accordingly, 
under current law, the anesthesia CF in effect in CY 2015 for the time 
period from April 1, 2015 through December 31, 2015 is $17.7913. We 
illustrate the calculation of the CY 2015 anesthesia CFs in Table 45.

           Table 46--Calculation of the CY 2015 Anesthesia CF
------------------------------------------------------------------------
 
------------------------------------------------------------------------
                 January 1, 2015 through March 31, 2015
------------------------------------------------------------------------
CY 2014 National Average            ....................        $22.6765
 Anesthesia CF.
Update............................  0.0 percent (1.00)..
CY 2015 RVU Budget Neutrality       0.0006 percent
 Adjustment.                         (0.9994).
CY 2015 Anesthesia Fee Schedule     0.005 percent
 Practice Expense Adjustment.        (.99524).
CY 2015 National Average            ....................        $22.5550
 Anesthesia CF (1/1/2015 through 3/
 31/2015).
------------------------------------------------------------------------
                 April 1, 2015 through December 31, 2015
------------------------------------------------------------------------
2014 National Average Anesthesia    ....................        $22.6765
 Conversion Factor in effect in CY
 2015.
2014 National Anesthesia            ....................        $17.2283
 Conversion Factor had Statutory
 Increases Not Applied.
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  -0.06 percent
 Malpractice Adjustment.             (0.9994).
CY 2015 Anesthesia Fee Schedule     0.005 percent
 Practice Expense Adjustment.        (.99524).
CY 2015 Anesthesia Conversion       ....................        $17.7913
 Factor (4/1/2015 through 12/31/
 2015).
Percent Change from 2014 to 2015    ....................          -21.5%
 (4/1/2015 through 12/31/2015).
------------------------------------------------------------------------

III. Other Provisions of the Final Rule 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 ambulance services shall be increased as 
follows:
    <bullet> For covered ground ambulance transports that originate in 
a rural area or in a rural census tract of a metropolitan statistical 
area, the fee schedule amounts shall be increased by 3 percent.
    <bullet> For covered ground ambulance transports that do not 
originate in a rural area or in a rural census tract of a metropolitan 
statistical area, 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 Pathway 
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) amended section 1834(l)(13)(A) of the Act to extend 
the payment add-ons again through March 31, 2015. Thus, these payment 
add-ons also apply to covered ground ambulance transports furnished 
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-implementing. A plain reading 
of the statute requires only a ministerial application of the mandated 
rate increase, and does not require any substantive exercise of 
discretion on the part of the Secretary. In the CY 2015 PFS proposed 
rule (79 FR 40372), we proposed to revise Sec.  414.610(c)(1)(ii) to 
conform 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 implementation of the 
ambulance payment add-ons. The commenter also agreed that these 
provisions are self-implementing.
    Response: We thank the commenter for their support of these 
provisions.
    After consideration of the public comment received, we are 
finalizing our proposal to revise Sec.  414.610(c)(1)(ii) to conform 
the regulations to these statutory requirements.
2. Amendment to Section 1834(l)(12) of the Act
    Section 414(c) of the Medicare Prescription 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 
shall provide for a percent increase in the base rate of the fee 
schedule for such transports. The statute requires this percent 
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 county populations as compared to the 
average cost per trip

[[Page 67744]]

for such services (not taking into account mileage) in the 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 ground ambulance 
transports that originated in a ``qualified rural area''; that is, to 
transports that originated in a rural area included in those areas 
comprising the lowest 25th percentile of all rural populations arrayed 
by 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 Bonus'' and the qualified rural areas 
(also known as ``super rural'' areas) are identified during the claims 
adjudicative process via the use of a data field included on the CMS-
supplied ZIP code File.
    The Super Rural Bonus under section 1834(l)(12) of the Act has been 
extended several times. Recently, section 1104(b) of the Pathway 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 Protecting 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 are continuing to apply the 
22.6 percent rural bonus described above (in the same manner as in 
previous years) to ground ambulance services with dates of service 
before April 1, 2015 where transportation originates in a qualified 
rural area. (For a discussion of past legislation extending section 
1834(l)(12) of the Act, please see the CY 2014 PFS final rule (78 FR 
74439 through 74440)).
    These statutory provisions are self-implementing. 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 Sec.  414.610(c)(5)(ii) to conform 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 implementation of the percent 
increase in the base rate of the fee schedule for transports in areas 
defined as super rural. The commenter also agreed with CMS that these 
provisions are self-implementing.
    Response: We thank the commenter for their support of these 
provisions.
    After consideration of the public comment received, we are 
finalizing our proposal to revise Sec.  414.610(c)(5)(ii) to conform 
the regulations to these 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 beneficiaries when other 
means of transportation are contraindicated by the beneficiary's 
medical condition, and all other coverage requirements are met. 
Ambulance services are classified into different levels of ground 
(including water) and air ambulance services based on the medically 
necessary treatment provided during transport.
    These services include the following levels of service:
    <bullet> For Ground--
    ++ Basic Life Support (BLS) (emergency and non-emergency)
    ++ Advanced Life Support, Level 1 (ALS1) (emergency and non-
emergency)
    ++ Advanced Life Support, Level 2 (ALS2)
    ++ Paramedic ALS Intercept (PI)
    ++ Specialty Care Transport (SCT)
    <bullet> 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 
(Supplemental Medical Insurance) covers and pays for ambulance 
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--
    <bullet> The ambulance benefit cover transportation services only 
if other means of transportation are contraindicated by the 
beneficiary's medical condition; and
    <bullet> Only ambulance service to local facilities be covered 
unless necessary services are not available locally, in which case, 
transportation to the nearest facility furnishing those services is 
covered (H.R. Rep. No. 213, 89th Cong., 1st Sess. 37 and Rep. No. 404, 
89th Cong., 1st Sess. Pt 1, 43 (1965)).
    The reports indicate that transportation may 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 limitations set forth at 
Sec.  410.12 and to specific conditions and limitations included at 
Sec.  410.40 and Sec.  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 schedule has used the same 
geographic area designations as the acute care hospital inpatient 
prospective payment system (IPPS) and other Medicare payment systems to 
take into account appropriate urban and rural differences. This 
promotes consistency across the Medicare program, and it provides for 
use of consistent geographic standards for Medicare 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-Based 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 rule (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 established revised delineations 
for Metropolitan Statistical Areas (MSAs), Micropolitan Statistical 
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/default/files/omb/bulletins/2013/b-13-01.pdf. According to OMB, ``[t]his

[[Page 67745]]

bulletin provides the delineations of all Metropolitan Statistical 
Areas, Metropolitan Divisions, Micropolitan Statistical 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 Statistical Area (referred to in this discussion as a 
Micropolitan Area) as a CBSA associated 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 
``Outside 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).
    Although the revisions OMB published on February 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 counties 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 proposed rule 
that we believe 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 rule (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 ambulance 
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 rural areas for ambulance 
fee schedule payment purposes. We believe that the updated OMB 
delineations more realistically reflect rural and urban populations, 
and that the use of such delineations under the ambulance fee schedule 
would result in more accurate payment. Under the ambulance fee 
schedule, consistent with our current definitions of urban and rural 
areas (Sec.  414.605), MSAs would continue to be recognized as urban 
areas, while Micropolitan and other areas outside MSAs, and rural 
census tracts within MSAs (as discussed below), would be recognized as 
rural areas.
    In addition to the OMB's statistical area delineations, 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 Sec.  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 time) version of the 
Goldsmith Modification, designated as Rural-Urban Commuting Area (RUCA) 
codes. RUCA codes use urbanization, population density, and daily 
commuting data to categorize every census tract in the country. For a 
discussion about RUCA codes, we refer the 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 delineations for Metropolitan Statistical Areas, Micropolitan 
Statistical Areas, and Combined Statistical Areas, and provided 
guidance on the use of the delineations of these statistical areas. 
Several modifications of the RUCA codes were necessary to take into 
account updated commuting data and the revised OMB delineations. We 
refer readers to the U.S. Department of Agriculture's Economic Research 
Service Web site for a detailed listing of updated RUCA codes found at 
http://www.ers.usda.gov/data-products/rural-urban-commuting-area-codes.aspx. The updated RUCA code definitions 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 most recent 
modifications of the RUCA codes beginning in CY 2015, to recognize 
levels of rurality in census tracts located in every county across the 
nation, for purposes of payment under 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, many 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 rural 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 core: primary flow with an urbanized area 
(UA).
    (2) Metropolitan area high commuting: primary 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: primary flow 10 to 30 percent to a 
large UC.
    (7) Small town core: primary flow within 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 services under the ambulance 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 
Administration (HRSA) determines eligibility for its rural grant 
programs through the use of the RUCA code methodology. Under this 
methodology, HRSA designates any census tract that falls in RUCA level 
4.0 or higher as a rural census tract. In addition to designating any 
census tracts falling at or above RUCA level 4.0 as rural areas, under 
the updated RUCA code definitions, HRSA has also designated as rural 
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

[[Page 67746]]

HRSA's Web site: 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, and (2) 
those census tracts that fall within RUCA levels 2 or 3 that are at 
least 400 square miles in area with a population density of no more 
than 35 people. We stated in the CY 2015 PFS proposed rule (79 FR 
40374) that we continue to believe that HRSA's guidelines accurately 
identify rural census tracts throughout the country, and thus would be 
appropriate to apply for ambulance payment purposes. We invited 
comments on this proposal.
    We stated in the CY 2015 PFS proposed rule (79 FR 40374) that the 
adoption of the most current OMB delineations and the updated RUCA 
codes would affect whether certain areas are recognized as rural or 
urban. The distinction between 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 rural 
is based on the point of pick-up for the transport, and thus a 
transport is paid differently depending on whether the point of pick-up 
is in an urban or a rural area. During claims processing, a geographic 
designation of urban, rural, or super rural is assigned to each claim 
for an ambulance transport based 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 rate is increased by a ``percent increase'' 
(Super Rural Bonus) where the ambulance transport originates in a 
``qualified rural area,'' which is a rural area that we determine to be 
in the lowest 25th percentile of all rural populations arrayed by 
population density (also known as a ``super rural area''). We implement 
this Super Rural Bonus in Sec.  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 updated RUCA codes would have no negative impact 
on ambulance transports in super rural 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 rule (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 rural 
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 (Sec.  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 (Sec.  
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 
rural areas are paid based on a rate (both base rate and mileage rate) 
that is 3 percent higher than otherwise is applicable. (See also Sec.  
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 otherwise outside of MSAs based on OMB's 
revised delineations or in a rural 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, while those 
ambulance providers and suppliers that pick up Medicare beneficiaries 
in areas that would be urban based on OMB's revised delineations 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 such transports because they would 
no longer be eligible for the rural adjustment 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 based 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 codes 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 proposed rule that, in general, it was expected that 
ambulance providers and suppliers in 100 ZIP codes within 11 states may 
experience payment increases if we adopt the revised OMB delineations 
and the updated RUCA codes, as these areas would be redesignated from 
urban to rural. We stated that the state of Ohio would have the most 
ZIP codes changing from urban to rural with a total of 40, or 2.69 
percent. We also stated in the CY 2015 PFS proposed rule that ambulance 
providers and suppliers in 122 ZIP codes within 22 states may 
experience payment decreases if we adopt the revised OMB delineations 
and the updated RUCA codes, as these areas would be redesignated from 
rural to urban. We stated that the state of West Virginia would have 
the most ZIP codes changing from rural to urban (17, or 1.82 percent), 
while Connecticut would have the greatest percentage of ZIP codes 
changing from rural to urban (15 ZIP codes, or 3.37 percent). Our 
findings were illustrated in Table 17 of the 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 delineations, 
coupled with the updated RUCA codes, more accurately reflect the 
contemporary urban and rural nature of areas across the country, and 
that use of the most current OMB delineations and RUCA codes under the 
ambulance fee schedule would enhance the accuracy of ambulance fee 
schedule payments. We solicited comments on our proposal to implement 
the new OMB delineations 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 suppliers 
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 are summarized below along with our responses.
    Comment: All of the commenters agreed with CMS that it is 
appropriate to adjust the geographic area designations periodically so 
that the ambulance fee 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

[[Page 67747]]

because it did not take into account the most recent modifications to 
the RUCA codes. When these codes are applied, the commenters stated 
that there would be substantially more ZIP codes that would shift. The 
commenters estimated that 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 commenters 
also stated that some ZIP codes would no longer have super rural 
status.
    Response: The commenters are correct that the analysis published in 
the CY 2015 PFS proposed rule (see Table 17 (79 FR 40375)) presented 
the impact of the revised OMB delineations only and did not include the 
impact of the updated RUCA codes. We did not receive the ZIP code 
approximation 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 designations for approximately 92.02 percent of ZIP 
codes would be unchanged by OMB's revised delineations and the updated 
RUCA codes. There are more ZIP codes that would change from rural to 
urban (3,038 or 7.08 percent) than 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 RUCA 
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 
state of California has the most ZIP codes changing from urban to rural 
with a total of 43, or 1.58 percent. 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. 
The state of Pennsylvania has the most ZIP codes changing from rural to 
urban (293, or 13.06 percent), while West Virginia has the greatest 
percentage of ZIP codes changing from rural to urban (269 ZIP codes, or 
28.74 percent). Our findings are illustrated in Table 47.
BILLING CODE 4120-01-P

[[Page 67748]]

[GRAPHIC] [TIFF OMITTED] TR13NO14.062


[[Page 67749]]


[GRAPHIC] [TIFF OMITTED] TR13NO14.063

BILLING CODE 4120-01-C
    As discussed above, in the CY 2015 PFS proposed rule (79 FR 40374), 
we proposed to designate as rural those census tracts 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 feasible to implement this 
proposal. Payment under the ambulance fee schedule is based on the ZIP 
codes; therefore, if the ZIP code is predominantly metropolitan but has 
some rural census tracts, we do not split the ZIP code areas to 
distinguish further granularity to provide different payments within 
the same ZIP code. We believe that payment for all ambulance 
transportation services at the ZIP code level provides a consistent 
payment system. Therefore, such census tracts were not considered rural 
areas in the updated analysis set forth above.
    For more detail on the impact of these changes, in addition to 
Table 47, the following files are available through the Internet on the 
AFS Web site at http://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/AmbulanceFeeSchedule/index.html: ZIP codes by state that 
changed from urban to rural, ZIP codes by state that changed from rural 
to urban, list of ZIP codes with RUCA code designations, and a complete 
list of ZIP codes identifying their designation as super rural, rural 
or urban.
    As reflected in Table 47, our findings are generally consistent 
with the commenters' findings that more than 1,500 ZIP codes would 
change from rural to urban (our updated analysis indicates that 3,038 
ZIP codes are changing), and that about three times the number of ZIP 
codes identified in the proposed rule (100) would change 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

[[Page 67750]]

rural and urban status and allow all interested parties to provide 
comments on the proposal. In addition to delaying implementation, the 
commenter suggested implementing a 4-year transition that would phase-
in the payment reduction over a specified period for those ZIP codes 
losing rural status.
    Other commenters requested that the implementation of the 
geographic adjustments 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 and 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 providers and suppliers had 
sufficient notice of and opportunity to comment on the proposed 
adoption of the revised OMB delineations and the updated RUCA codes 
under the ambulance fee schedule, 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 revised OMB delineations and 
updated RUCA codes would affect the urban/rural designation of certain 
areas, and thus would affect whether transports in certain areas would 
be eligible for rural adjustments 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 analysis 
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 Web site, which provided ambulance providers and 
suppliers with additional information regarding changes to the level of 
rurality in census tracts. Furthermore, 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 Sec.  414.605, is that 
rural areas include rural census tracts as determined under the most 
recent version of the Goldsmith modification.
    As discussed above and in the CY 2015 PFS proposed 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 delineations and RUCA codes under the ambulance 
fee schedule will enhance the accuracy of ambulance fee schedule 
payments. We believe that it is important to use the most current OMB 
delineations 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 believe the revised OMB 
delineations and updated RUCA codes more accurately identify urban and 
rural areas and enhance the accuracy of the Medicare ambulance fee 
schedule, we do not believe a delay in implementation or a transition 
period would be appropriate. Areas that lose their rural status and 
become urban have become urban because of recent population shifts. We 
believe it is important to base payment on the most accurate and up-to-
date geographic area delineations available. Furthermore, we believe a 
delay would disadvantage the ambulance providers or suppliers 
experiencing payment increases based on these updated and more accurate 
OMB delineations and RUCA 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 changing their urban/rural status out of 
42,918 ZIP codes, or 7.98 percent), we do not believe that a delay is 
warranted. As commenters requested, we have included in Table 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 adoption of the 
revised OMB delineations and the updated RUCA codes, then CMS should 
grandfather the current super rural ZIP codes. Another commenter stated 
that the ambulance providers must have verification from CMS that the 
super rural ZIP codes will not be affected by the changes described in 
the proposed rule in advance of their implementation in the final rule.
    Response: As we stated previously, 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 super 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 
ambulance fee schedule. As we proposed, using the updated RUCA codes 
definitions, 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 census 
tracts that fall within RUCA codes 2 or 3 that are at least 400 square 
miles in area with a population density of no more than 35 people. 
Finally, as discussed above, 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.

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 would 
reexamine the payment amounts for test codes on the Clinical Laboratory 
Fee Schedule (CLFS) for possible payment revision based on 
technological changes beginning with the CY 2015 proposed rule, and we 
codified this process at Sec.  414.511. After we finalized this 
process, the Congress enacted the PAMA. Section 216 of the PAMA creates 
new section 1834A of the Act, 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 rescinds the 
statutory authority in section 1833(h)(2)(A)(i) of the Act for 
adjustments based on technological changes 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 based on technological changes, and we proposed 
to remove Sec.  414.511.
    We did not receive any public comments on this proposal. Therefore, 
we are finalizing our proposal to remove Sec.  414.511. In addition, we 
will establish through rulemaking the parameters for

[[Page 67751]]

the collection of private payor rate information and other requirements 
to implement section 216 of the PAMA.

D. Removal of Employment Requirements for Services Furnished ``Incident 
to'' Rural Health Clinics (RHC) and Federally Qualified Health Center 
(FQHC) Visits

1. Background
    Rural Health Clinics (RHCs) and Federally Qualified Health Centers 
(FQHCs) furnish physicians' services; services and supplies ``incident 
to'' the services of physicians: Nurse practitioner (NP), physician 
assistant (PA), certified nurse-midwife (CNM), clinical psychologist 
(CP), and clinical social worker (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 therapy (DSMT/MNT), transitional care management services, 
and in some cases, visiting nurse services furnished by a registered 
professional nurse or a licensed practical nurse. (For additional 
information on coverage requirements for services furnished in RHCs and 
FQHCs, see Chapter 13 of the CMS Benefit Policy Manual.)
    In the May 2, 2014 final rule with comment period entitled 
``Prospective Payment System for Federally Qualified Health Centers; 
Changes to Contracting Policies for Rural Health Clinics; and Changes 
to Clinical Laboratory Improvement Amendments of 1988 Enforcement 
Actions for Proficiency Testing Referral'' (79 FR 25436), we removed 
the regulatory 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, PAs, CNMs, CSWs, and CPs, as long as at 
least one NP or PA is employed by the RHC, as required under clause 
(iii) in the first sentence of the flush material following 
subparagraph (K) of section 1861(aa)(2) of the Act.
    Services furnished in RHCs and FQHCs by nurses, medical assistants, 
and other auxiliary personnel are considered ``incident to'' a RHC or 
FQHC visit furnished by a RHC or FQHC practitioner. Sections 
405.2413(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 the RHC or FQHC. Since there is no separate benefit 
under Medicare law that specifically authorizes payment to nurses, 
medical assistants, and other auxiliary personnel for their 
professional services, they cannot bill the program directly and 
receive payment for their services, and can only be remunerated when 
furnishing services to Medicare 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 Sec.  405.2413(a)(5), 
Sec.  405.2415(a)(5) and Sec.  405.2452(a)(5) and delete Sec.  
405.2413(a)(6), Sec.  405.2415(a)(6) and Sec.  405.2452(a)(6) to remove 
the requirement 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 assistants, and other auxiliary personnel to 
furnish ``incident to'' services under contract 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 were 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 recruit highly qualified health professionals, and fill 
temporary staffing voids without adversely impacting the quality of 
care. 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 support removal of the employment 
requirement, provided that RHC and FQHC auxiliary personnel are held to 
the same high professional standards for the quality of care, 
regardless of whether they are working under contract or as employees. 
Commenters also added that all members of a physician-led health care 
team should be enabled to perform medical interventions that they are 
capable of performing according to their education, training, 
licensure, and experience.
    Response: The proposal to remove the requirement 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 assistants, and other auxiliary personnel are 
expected to maintain their professional standards of care and furnish 
services in adherence to their scope of practice, regardless of whether 
they are employed or contracted by the RHC or FQHC.
    Comment: Some commenters stated that although they understand 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 commenters questioned whether the issue was 
investigated or vetted, and how RHCs and 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 contracted 
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 finalizing this 
provision as proposed.

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

1. Background and Statutory Authority
    Section 3021 of the Affordable Care Act amended the Social Security 
Act to include a new section 1115A, which established the Center for 
Medicare and Medicaid Innovation (Innovation Center). Section 1115A 
tasks the Innovation 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 individuals under 
titles XVIII, XIX, and XXI of the Act. The Secretary is also required 
to conduct an evaluation of each model tested.
    Evaluations will typically include quantitative and qualitative 
methods to assess the impact of the model on quality of care and health 
care expenditures. To comply with the statutory requirement to evaluate 
all models conducted under section 1115A of the Act, we will conduct 
rigorous quantitative analyses of the impact of the model test on 
health care expenditures, as well as an assessment of measures of the 
quality of care furnished under the model test. Evaluations will also 
include qualitative analyses to capture the qualitative differences 
between model participants, and to form the context within which to 
interpret the quantitative findings. Through the qualitative analyses, 
we will assess the experiences and perceptions of model participants, 
providers, and individuals affected by the model.
    In the evaluations we use advanced statistical methods to measure

[[Page 67752]]

effectiveness. Our methods are intended to provide results that meet 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 specifically which individuals are receiving 
services from or are the subject of the intervention being tested by 
the entity participating in the model test. Identification of such 
individuals is necessary for a variety of purposes, including the 
construction of control groups against which model performance can be 
compared. In addition, to determine whether the observed impacts are 
due to the model being tested and not due to differences between the 
intervention and comparison groups, our evaluations will have to 
account for potential confounding factors at the individual level, 
which 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 factors 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. Individuals 
receiving services from or who are the subjects of the intervention 
will be compared to clinically, socio-demographically, and 
geographically similar matched individuals along various process, 
outcome, and patient-reported measures. Research questions in a typical 
evaluation will include, but are not limited to, the following:
    <bullet> 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, and for which individuals?
    ++ Did the model improve or have a negative impact on clinical 
outcome measures, such as mortality rates, and the incidence and 
prevalence 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 negative impact on care 
coordination among providers? If so, how, how much, and for which 
individuals?
    ++ Did the model improve or have a negative impact on medication 
management? If so, how, how much, and for which individuals?
    <bullet> 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 negative impact on patient 
experiences of care, quality of life, or functional status? If so, how, 
how much, and for which individuals?
    <bullet> Utilization/Expenditures:
    ++ Did the model result in decreased utilization of emergency 
department visits, hospitalizations, and readmissions? If so how, how 
much, and for which individuals?
    ++ Did the model result in increased 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 
changes in total costs of care driven by changes in utilization for 
specific types of settings or health care services? What specific 
aspects of the model led to these changes? Were any savings due to 
improper cost-shifting to the Medicaid program?
    To carry out this research we must have access 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 testing 
of past, present, and future models under section 1115A of the Act to 
collect and report information that we have determined is necessary to 
monitor 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 
identifiable health information and such other information as the 
Secretary identifies as being necessary to conduct the statutorily 
mandated research described above. Such research will include the 
monitoring and evaluation of such models. Further, we view engagement 
with other payers, both public and private, as a critical driver of the 
success of these models. CMS programs constitute only a share of any 
provider's revenue. Therefore, efforts to improve quality and reduce 
cost are more likely to be successful if efforts are aligned across 
payers. Section 1115A of the Act specifically allows the Secretary of 
Health and Human Services to consider, in selecting which models to 
choose for testing, ``whether the model demonstrates effective linkage 
with other public sector or private sector payers.'' Multi-payer 
models, such as but not limited to the Comprehensive Primary Care 
model, will conduct quality measurement across all patients regardless 
of payer in order to maximize alignment and increase efficiency. 
Construction of multi-payer quality measures requires the ability to 
identify all individuals subject to the model test regardless of payer. 
In addition, section 1115A also permits the Secretary to consider 
models that allow states to test and evaluate systems of all-payer 
payment reform for the medical 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. The premise of the SIM 
initiative is to support Governor-sponsored, multi-payer models that 
are focused on public and private sector collaboration to transform the 
state's payment and delivery system. States have policy and regulatory 
authorities, as well as ongoing relationships with private payers, 
health plans, and providers that can accelerate delivery system reform. 
SIM 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 considerable limitations on the level of evaluation 
conducted. Therefore, under this authority, we also proposed to require 
the submission of identifiable health and utilization information for 
patients of private payers treated by providers/suppliers participating 
in the testing of a model under section 1115A of the Act when an 
explicit purpose of the model test is to engage private sector payers. 
This regulation will provide clear legal authority for Health Insurance 
Portability and Accountability Act (HIPAA) Covered Entities to disclose 
any required protected health information. Identifiable data submitted 
by entities participating in the testing 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 
will also meet all E-Gov requirements. In accordance with the 
requirements of the Privacy 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

[[Page 67753]]

stored until the evaluation is complete and all necessary policy 
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 administrative 
systems. However, evaluations will generally also need to include 
additional data not available through existing CMS administrative 
systems. As such, depending on the particular project, CMS or its 
contractor will require the production of the minimum data necessary to 
carry out the statutorily mandated research work described in section 
E.1. of this final rule with comment period. Such data may include the 
identities of the patients served under the model, relevant clinical 
details about the services furnished and outcomes achieved, and any 
confounding 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 information that 
could be required to carry out an evaluation, and for which the 
evaluator would need patient-level identifiers.
    <bullet> Utilization data not otherwise available through existing 
Centers for Medicare & Medicaid Services (CMS) systems.
    <bullet> Beneficiary, patient, participant, family, and provider 
experiences.
    <bullet> Beneficiary, patient, participant, and provider rosters 
with identifiers that allow linkages across time and datasets.
    <bullet> Beneficiary, patient, participant, and family socio-
demographic and ethnic characteristics.
    <bullet> Care management details, such as details regarding the 
provision of services, payments or goods to beneficiaries, patients, 
participants, families, or other providers.
    <bullet> Beneficiary, patient, and participant functional status 
and assessment data.
    <bullet> Beneficiary, patient, and participant health behaviors.
    <bullet> Clinical data, such as, but not limited to lab values and 
information from EHRs.
    <bullet> Beneficiary, patient, participant quality data not 
otherwise available through claims.
    <bullet> Other data relevant to identified outcomes--for example, 
participant employment status, participant educational degrees pursued/
achieved, and income.
    We invited public comment on this proposal 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 identifiable 
information necessary to conduct the statutorily mandated research 
under section 1115A of the Act.
    Comment: Commenters consistently recognized the need to evaluate 
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 de-identified data from evaluations available to 
external researchers. Although supportive of the need to evaluate 
Innovation Center models, several commenters stated the Innovation 
Center had not sufficiently justified the need for individually 
identifiable patient information, and suggested aggregate or de-
identified data should be sufficient. One commenter suggested the 
submission of performance rates, patient outcomes information, and/or 
composite scores for participating providers instead of individual 
patient-level data. The commenter 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 methodologies 
and solicit feedback from independent research experts as to the need 
for patient-level data.
    Response: We appreciate the commenters' support for rigorous 
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 Information 
Act. With respect to comments recommending the use of aggregate or de-
identified data instead of individually identifiable data, as we 
discussed in the preamble of the proposed rule, we believe individually 
identifiable data is necessary. As noted in this final rule with 
comment 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 satisfaction, 
sustainability, potential for the model to be applied on a broader 
scale, and total cost of care. Furthermore, individuals receiving 
services from or who are the subjects of the intervention will be 
compared to clinically, socio-demographically, and geographically 
similar matched individuals along 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 services as a result of the model, 
the evaluation analyses could include individuals not even subject to 
the intervention, and therefore, there would be a very real possibility 
that positive impacts of the model may be diluted and unobservable. 
While aggregate data could be limited to the target population, 
identification of which individuals 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 model will also 
allow the evaluators to construct matched comparison groups that look 
as similar as possible to the intervention group. The absence of a 
well-matched comparison group, which can only be achieved when 
individually identifiable characteristics are known, could result in 
impact estimates 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 patient-level data from 
proprietary registries would be limited to data necessary to conduct a 
credible evaluation. Data on individuals are also needed to assess 
differential impacts among subgroups of beneficiaries to identify who 
benefits most from the intervention. We agree it is important to seek 
expert opinion on the structure of our assessment methods, 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 to 
technical expert panels for added guidance. As a result, the design and 
implementation of

[[Page 67754]]

these assessments are informed by those with expertise in health 
services research, economics, statistics, program evaluation, 
epidemiology, and public health.
    Comment: Although generally supportive of the need for rigorous 
evaluations, some commenters worried that any requirement to provide 
individually identifiable 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, 
potentially, overbroad) amounts of individually identifiable patient-
level data. A few commenters suggested that the Innovation Center 
should first look to other federal government 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 other 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, 
including the complexities associated with abstracting data from 
electronic health records. We further agree that in making 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.
    Reimbursement may be considered for future models, but if adopted, 
any such reimbursement, and any conditions for such reimbursement, 
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 understand the data 
collection requirements before the model begins, so that they may take 
these requirements into consideration. We do not agree, though, that 
model participants should be given the opportunity to opt out of 
producing the required information, as this would undermine 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 
individuals are that are the subjects of the model test without the 
need to obtain identifiers from the model participants. 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 identifiers, we may still need to obtain 
other person-level data, such as clinical information. In other models, 
where a specific beneficiary-level payment is not being made, the 
evaluation contractor 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 evaluator 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 (such 
as, but not limited to, the Medicare Health Insurance Claim number) are 
required. 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 limit data demands, and the attendant costs, to the data necessary 
to accomplish the required monitoring and assessment.
    Comment: Some commenters stated the requirement could result in 
requests for data from providers tangentially involved in an Innovation 
Center project to report any data the agency decides it needs. A few 
commenters further stated the Innovation Center should ensure that all 
participating entities seek patient authorizations to use their records 
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 participate in, or 
that receives payment from us under, a model we are testing. In 
response to the comment suggesting that the Innovation Center 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 requirement 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 Center should 
publish and be transparent about what the exact data reporting and 
collection requirements 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 their 
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 elements that are 
required for evaluation purposes for the existing programs and this 
information should be shared with participants who should, at minimum, 
be given an opportunity to provide comment on the required inputs for 
which they will be responsible as part of the evaluation. These 
commenters also stated the Innovation Center should develop such 
requirements in advance of the program start for participants to allow 
them an opportunity to provide feedback and weigh the information as 
part of their decision to participate in the model.
    Response: We agree it is important to restrict data requests to the 
data necessary to conduct credible monitoring and evaluation. We 
frequently 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 development and 
implementation. Further, in order for potential model participants to 
understand the likely data reporting requirements, to the extent 
feasible, these requirements are incorporated into the solicitation 
process. However, we decline to adopt a requirement to undertake a 
notice and comment process as part of our determination of what data 
are necessary for monitoring or evaluation 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 specify the particular data elements that will be required for 
monitoring and evaluation prior to the start of the model. It is not

[[Page 67755]]

always possible at that early stage of the model to know precisely what 
data elements will be necessary. However, we will strive to provide as 
much relevant detail 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 any comments received into account in determining our data needs.
    Comment: A few commenters stated that CMS has not provided 
sufficient assurances that providers, in responding to these data 
requests, would be protected or deemed to be in compliance with the 
HIPAA requirements for the use and disclosure of protected health 
information (PHI). These commenters stated the Innovation Center 
reference to requiring reporting of individually identifiable patient-
level data raises significant privacy concerns for providers who would 
be required to report such data. These commenters 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 evaluation are doing so consistent with their HIPAA 
obligations. These commenters 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. These same 
commenters suggested that the Innovation Center should work with OCR to 
issue OCR guidance stating that providers reporting data as part of an 
evaluation are doing so consistent with their HIPAA obligations. Some 
commenters stated CMS should consider the necessary data elements on a 
program-by-program basis rather than establishing a blanket approval, 
or at minimum limit the scope of the approved data requirements and 
uses, and should provide clear instructions and other educational 
resources to ensure that collection and reporting of the data complies 
with the HIPAA Privacy and Security rules.
    Response: We appreciate the concerns expressed about compliance 
with the HIPAA requirements and the recommendation to work with OCR. 
However, we respectfully disagree that sufficient assurances have not 
been provided. 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 164.103. A HIPAA covered 
entity is permitted to disclose protected health information as 
required by law under these provisions so long as the disclosure 
complies with and is limited to the relevant requirements of the law. A 
separate minimum data necessary determination is not required under the 
HIPAA Privacy Rule for required by law disclosures under 45 CFR 
164.512(a). See 45 CFR 164.502(b)(2). Although a separate minimum data 
necessary determination is not required, as a policy matter and 
consistent with the statutory authority under 1115A(b)(4), CMS will 
only require that data we determine is necessary for evaluation and 
monitoring 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 commenter 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 against 
inappropriate use or disclosure of patient identifiable data.
    Response: We agree that it is critical to abide 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 requirements, providers' and 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 suppliers 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 subject to the Part 2 regulations.
    Comment: One commenter stated CMS should not use these data for 
purposes other than those articulated in the proposed rule, and that 
the assessments should comply with the applicable statutory 
requirements, meaning that: (1) The assessments should take into 
account 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 criteria); (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 evaluations should assess quality of care, 
and the patient-de-identified results should be made publicly 
available, 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 
identifiable information necessary to conduct the statutorily mandated 
research under section 1115A of the Act. We are accepting the 
recommendations made by commenters to minimize participant burden, seek 
input from providers, and use independent researchers. In addition, we 
are finalizing our proposal to add a new subpart K in part 403 to 
implement section 1115A of the Act without modification.

F. Local Coverage Determination Process for Clinical Diagnostic 
Laboratory Testing

    The CY 2015 proposed rule (79 FR 40378 through 40380), section 
III.F., included discussion of a proposal to modify the existing 
process used by the Medicare Administrative Contractors (MACs) in 
developing local coverage determinations (LCDs) for clinical diagnostic 
laboratory tests. Briefly, the proposal would have expedited the 
timeline for LCD development for clinical diagnostic laboratory test 
LCDs by reducing the calendar days for some of the steps and by making 
optional or eliminating other steps within the current process. A 
detailed discussion of the proposal is available in section 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 issue. 
Comments were received from individual members of the public, insurers, 
drug manufacturers, medical specialty societies, laboratory groups and 
individual laboratories. The commenters focused their comments on the 
following issues: The proposal to reduce the draft LCD public comment 
period 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

[[Page 67756]]

LCDs becoming effective. In addition, commenters were concerned about 
the proposed changes in light of section 216 of the Protecting Access 
to Medicare Act of 2014 (PAMA), titled ``Improving Medicare Policies 
for Clinical Diagnostic Laboratory Tests.'' The comments received have 
given 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 possibility 
of future notice-and-comment rulemaking on this issue.

G. Private Contracting/Opt-Out

1. Background
    Effective January 1, 1998, section 1802(b) of the Act permits 
certain physicians and practitioners to opt-out of Medicare if certain 
conditions are met, and to furnish through private contracts services 
that would otherwise be covered by Medicare. For those physicians and 
practitioners who opt-out of Medicare in accordance 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 limiting 
charge rules. Regulations governing the requirements and procedures for 
private contracts appear at 42 CFR part 405, subpart D.
a. Opt-Out Determinations (Sec.  405.450)
    The private contracting regulation at Sec.  405.450 describes 
certain opt-out determinations made by Medicare, and the process that 
physicians, practitioners, and beneficiaries may use to appeal those 
determinations. Section 405.450(a) describes the process available for 
physicians or practitioners to appeal Medicare enrollment 
determinations related to opting out of the program, and Sec.  
405.450(b) describes the process available to challenge payment 
determinations related to claims for services furnished by physicians 
who have opted out. Both provisions refer to Sec.  405.803, the Part B 
claims appeals process that was in place at the time the opt-out 
regulations were issued (November 2, 1998). When those regulations were 
issued, a process for a physician or practitioner to appeal 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 the existing claims 
appeals process in Sec.  405.803 for both enrollment and claims related 
appeals.
    In May 16, 2012 Federal Register (77 FR 29002), we published a 
final rule entitled ``Medicare and Medicaid Program; Regulatory 
Provisions to Promote Program Efficiency, Transparency and Burden 
Reduction.'' In that final 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 regarding an 
individual's entitlement to benefits under Medicare Part A and Part B, 
which were contained in part 405, subparts G and H (including Sec.  
405.803) because these provisions were obsolete and had been replaced 
by the regulations at part 405, subpart I. We inadvertently neglected 
to revise the cross-reference in Sec.  405.450(a) and (b) of the 
private contracting regulations to direct 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 channel for physicians and 
practitioners to challenge an enrollment related opt-out decision made 
by Medicare. There are now two different sets of appeal regulations for 
initial determinations; and the appeal of enrollment related opt-out 
determinations is more like the types of determinations now addressed 
under part 498 than those under part 405, subpart I. Specifically, the 
appeal process under part 405, subpart I focuses on reviews of 
determinations 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 regarding the participation 
or enrollment status of providers and suppliers. Enrollment related 
opt-out determinations involve only the status of particular physician 
or practitioners under Medicare, and do not involve beneficiary 
eligibility or 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 appeals process 
established in part 498 is the appropriate mechanism for challenging 
payment decisions 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 appeals 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 Contracts 
(Sec. Sec.  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 ``Emergency 
care services'' which means services furnished to an individual for 
treatment of an ``emergency medical condition'' as that term is defined 
in Sec.  422.2. The cross-referenced regulation at Sec.  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 cross-reference within the definition 
of emergency care services should have been amended at that time to 
cite the definition of ``emergency services'' in Sec.  424.101.
    The private contracting regulations at Sec.  405.420(e), Sec.  
405.425(a) and Sec.  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 plans are 
referred to as Medicare Advantage plans. When part 422 of the 
regulations was updated on January 28, 2005 (70 FR 4741), we 
inadvertently neglected to revise Sec.  405.420(e), Sec.  405.425(a) 
and Sec.  405.455 to replace the term Medicare+Choice with Medicare 
Advantage plan.
2. Provisions of the Proposed Regulation
    For the reasons discussed above, we proposed that a determination 
described in Sec.  405.450(a) (relating to the status of opt-out or 
private contracts) is an initial determination for purposes of Sec.  
498.3(b), and a physician or practitioner who is dissatisfied with a 
Medicare determination under Sec.  405.450(a) may utilize the 
enrollment appeals process currently available for providers and 
suppliers in part 498. In addition, we proposed that a determination 
described in Sec.  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 Sec.  
405.924 and may be challenged through the existing claims appeals 
procedures in part 405 subpart I. Accordingly, we proposed that the 
cross

[[Page 67757]]

reference to Sec.  405.803 in Sec.  405.450(a) be replaced with a cross 
reference to Sec.  498.3(b). We also proposed that the cross reference 
to Sec.  405.803 in Sec.  405.450(b) be replaced with a cross reference 
to Sec.  405.924. We also proposed corresponding edits to Sec.  
498.3(b) and Sec.  405.924 to note that the determinations under Sec.  
405.450(a) and (b), respectively, are initial determinations.
    For the reasons discussed above, we also proposed that the 
definition of Emergency care services at Sec.  405.400 be revised to 
cite the definition of Emergency services in Sec.  424.101 and that all 
references to Medicare+Choice in Sec.  405.420(e), Sec.  405.425(a) and 
Sec.  405.455 be replaced with the term ``Medicare Advantage.''
    The following is a summary of the comments 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 regulations. 
Nevertheless, we note that section 1802(b)(3)(B)(ii) of the Act 
specifies that the opt-out affidavit must provide that the ``physician 
or practitioner will not submit any claim under this title for any item 
or service provided to any medicare beneficiary. . . during the 2-year 
period beginning on the date the affidavit is signed.'' As such, the 
longest interval for which an opt-out can be effective is 2 years. We 
have no authority to modify that statutory requirement.
    Because we did not receive any comments on our proposals, we are 
finalizing the rule as proposed.

H. Solicitation of Comments on the Payment Policy for Substitute 
Physician Billing Arrangements

1. Background
    In accordance with section 1842(b)(6) of the Act, no payment under 
Medicare Part B may be made to anyone other than to the beneficiary to 
whom a service was furnished or to the physician or other person who 
furnished the service. However, there are certain limited exceptions to 
this general prohibition. For example, section 1842(b)(6)(D) of the Act 
describes an exception for substitute physician billing arrangements, 
which states that ``payment may be made to a physician for physicians' 
services (and services furnished incident to such services) furnished 
by a second physician to patients of the first physician if (i) the 
first physician is unavailable to provide the services; (ii) the 
services 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 
period of more than 60 days or are provided over a longer continuous 
period during all of which the first physician has been called or 
ordered to active duty as a member of a reserve component of the Armed 
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 this subparagraph for payment to the first 
physician.'' Section 1842(b)(6) of the Act is self-implementing and we 
have not interpreted the 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 informal 
reciprocal arrangement where doctor A substitutes for doctor B on an 
occasional basis and doctor B substitutes for doctor A on an occasional 
basis; and (2) an arrangement where the services of the substitute 
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 physicians 
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 are 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 staffing 
needs (for example, in physician shortage areas) or, on a temporary 
basis, to replace physicians who have permanently left a medical group 
or employer.
    We are concerned about the operational and program integrity issues 
that result from the use of substitute physicians to fill staffing 
needs or to replace a physician who has permanently left a medical 
group or employer. For example, although our Medicare enrollment rules 
require physicians and physician groups or organizations to notify us 
promptly of any enrollment changes (including reassignment changes) 
(see Sec.  424.516(d)), processing delays or miscommunication between 
the departing physician and his or her former medical group or employer 
regarding which party would report the change to Medicare could result 
in the Provider Transaction Access Number (PTAN) that links the 
departed physician and his or her former 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 Identifier (NPI) for furnished services. This could occur 
where a substitute physician is furnishing services in place of the 
departed physician in the departed physician's former medical group, 
while the departed physician is also furnishing services to 
beneficiaries following departure from the former group. Operationally, 
either or both types of claims could be rejected or denied, even though 
the claims filed by the departed physician were billed appropriately. 
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, section 1842(b)(6)(D)(iv) of the Act 
requires that the claim form submitted to the MAC include the 
substitute physician's unique identifier. Currently, the unique 
identifier used to identify a physician is the physician's NPI. Prior 
to the implementation of the NPI, the Unique Physician Identification 
Number (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 furnish 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 indicating that the services were furnished 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

[[Page 67758]]

Processing Manual (Pub. 100-4), Chapter 1, Sections 30.2.10 and 
30.2.11) However, having a NPI or UPIN does not necessarily mean that 
the substitute physician is enrolled in the Medicare program. Without 
being enrolled in Medicare, we do not know whether the substitute 
physician has the proper credentials to furnish the services being 
billed under section 1842(b)(6)(D) of the Act or if the substitute 
physician is sanctioned or excluded from Medicare. The importance of 
enrollment and the resulting transparency afforded the Medicare program 
and its beneficiaries was recognized by the Congress when it included 
in the Affordable Care Act a requirement that physicians and other 
eligible non-physician practitioners (NPPs) enroll in the Medicare 
program if they wish to order or refer certain items or services for 
Medicare beneficiaries. This includes those physicians 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 transparency in the context of 
substitute physician billing arrangements for the identity of the 
individual actually furnishing 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 section 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 beneficiary access to physician 
services.
    We received a few comments on the issues raised in this 
solicitation. We thank the commenters for their input, and we will 
carefully consider their comments in any future rulemaking on this 
subject.

I. Reports of Payments or Other Transfers 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 Interests'' 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 (applicable manufacturers) are required to submit on an annual 
basis information about certain payments or other transfers of value 
made to physicians and teaching hospitals (collectively called covered 
recipients) during the course of the preceding calendar year. Section 
1128G(a)(2) of the Act requires applicable manufacturers and applicable 
group purchasing organizations (GPOs) to disclose any ownership or 
investment interests in such entities 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 organized these reporting 
requirements under the ``Open Payments'' program.
    The Open Payments program creates transparency around the nature 
and extent of relationships that exist between drug, device, 
biologicals and medical supply manufacturers, and physicians and 
teaching hospitals (covered recipients and physician owner or 
investors). The implementing regulations, which describe procedures for 
applicable manufacturers and applicable GPOs to submit electronic 
reports detailing payments or other transfers of value and ownership or 
investment interests provided to covered recipients and physician 
owners or investors, are codified at Sec.  403.908.
    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, Sec.  403.904(g)(1) excludes the reporting of payments 
associated with certain continuing education events, and Sec.  
403.904(c)(8) requires reporting of the marketed name for drugs and 
biologicals but makes reporting the marketed name of devices or medical 
supplies optional. We proposed a change to Sec.  403.904(g) to correct 
an unintended consequence of the current regulatory text. Additionally, 
at Sec.  403.904(c)(8), we proposed to make the reporting requirements 
consistent by requiring the reporting of the marketed name for drugs, 
devices, biologicals, or medical supplies which are associated with a 
payment or other transfer of value.
    Additionally, at Sec.  403.902, we proposed to remove the 
definition of a ``covered device'' because we believe it is duplicative 
of the definition of ``covered drug, device, biological or medical 
supply'' which is codified in the same section. We also proposed to 
require the reporting of the following distinct forms of payment: 
stock; stock option; or any other ownership interests specified in 
Sec.  403.904(d)(3) to collect more specific data regarding the forms 
of payment.
2. Continuing Education Exclusion (Sec.  403.904(g)(1))
    In the February 8, 2013 final rule, many commenters recommended 
that accredited or certified continuing education payments to speakers 
should not be reported because there are safeguards already in place, 
and they are not direct payments to a covered recipient. In the final 
rule preamble, we noted that ``industry support for 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 following three conditions are met:
    <bullet> The event at which the covered recipient is speaking must 
meet the accreditation or certification requirements and standards for 
continuing education for one of the following organizations: the 
Accreditation Council for Continuing Medical Education (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 Osteopathic 
Association (AOA).
    <bullet> The applicable manufacturer does not pay the covered 
recipient speaker directly.
    <bullet> The applicable manufacturer does not select the covered 
recipient speaker or provide the third party (such as a continuing 
education vendor) with a distinct, identifiable set of individuals to 
be considered as speakers for the continuing education program.
    Since the implementation of Sec.  403.904(g)(1), other accrediting 
organizations have requested that payments made to speakers at their 
events also be exempted from reporting. These organizations have stated 
that they follow the same accreditation standards as the organizations 
specified in Sec.  403.904(g)(1)(i). Other stakeholders have 
recommended that the exemption be removed in its entirety stating

[[Page 67759]]

removal of the exclusion will 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. 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 education 
events was an unintended consequence of the final rule.
    After consideration of these comments, we proposed to remove the 
language in Sec.  403.904(g) in its entirety, in part because it is 
redundant with the exclusion in Sec.  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 
the end of the second quarter of the following reporting year. When an 
applicable manufacturer or applicable GPO provides funding to a 
continuing education provider, but does not either select or pay the 
covered recipient speaker directly, or provide the continuing education 
provider with a distinct, identifiable set of covered recipients to be 
considered as speakers for the continuing education program, CMS will 
consider those payments to be excluded from reporting under Sec.  
403.904(i)(1). This approach is consistent with our discussion in the 
preamble to the final rule, in which we explained that if an applicable 
manufacturer conveys ``full discretion'' to the continuing education 
provider, those payments are outside the scope of the rule (78 FR 
9492). In contrast, for example, when an applicable manufacturer 
conditions its financial sponsorship of a continuing education event on 
the participation of particular covered recipients, or pays a covered 
recipient 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 organizations in Sec.  
403.904(g)(1)(i) by name; however, 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 
Sec.  403.904(g)(1)(i) by articulating accreditation or certification 
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 the exclusion for compensation for speaking at a continuing 
education program. Some comments were in support to remove the 
exclusion stating 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. Numerous commenters 
questioned our proposal to remove the exclusion for compensation for 
speaking at a continuing education program. Commenters provided 
background regarding accrediting continuing education organizations 
stating that creating continuing education accreditation standards is a 
function of professional self-regulation and additional government 
regulation is not necessary.
    Many commenters recommend modifying the indirect payment exclusion 
currently at Sec.  403.904(i)(1) to specify a continuing education 
indirect payment 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 organization. This differs 
from the current indirect payment exclusion language which states the 
payment is excluded if the manufacturer did not know the identity of 
the covered recipient during the reporting year or by the end of the 
second quarter of the following reporting year. Commenters stated it is 
not practical for a manufacturer to not know the identity of a 
physician speaker receiving compensation 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 could 
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 provided to 
physicians at a continuing education event and recommend the indirect 
payment exclusion is modified to accommodate indirect payments provided 
to a physician covered recipient through a continuing medical education 
organization.
    Additionally, commenters suggested an alternative approach where 
CMS would adopt 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 suggested by commenters to 
modify the exclusion were: does not pay covered speakers or attendees 
directly, does not select 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 education 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 organizations is a function of professional self-
regulation. We believe creating consistent reporting requirements for 
all continuing education events, by removing the language in Sec.  
403.904(g) in its entirety, will provide enhanced regulatory clarity 
for stakeholders. Manufacturers reporting compensation paid to 
physician speakers may opt to distinguish if the payment was provided 
at an accredited or certified continuing education program versus an 
unaccredited or non-certified continuing education program by selecting 
the appropriate nature of payment category at Sec.  403.904(e).
    We understand commenters concern regarding learning the identity of 
the physician during the reporting year or by the end of the second 
quarter of the following reporting year. In the situation of an 
applicable manufacturer providing an indirect 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 second 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. However, 
payments or other transfers of value, including payments made to 
physician covered recipients for purposes of attending or speaking at 
continuing education events, which do not meet the definition of an 
indirect payment, as

[[Page 67760]]

defined at Sec.  403.902, are not reportable. For example, if an 
applicable manufacturer or applicable GPO provides funding to support a 
continuing education event but does not require, instruct, direct, or 
otherwise cause the continuing education event provider to provide the 
payment or other transfer or value in whole or in part to a covered 
recipient, the applicable manufacturer or applicable GPO is not 
required to report the payment or other transfer of value. The payment 
is not reportable regardless if the applicable manufacturer or 
applicable GPO learns the identity of the covered recipient during the 
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 
grants to physicians, those grants would not constitute `indirect 
payments' because the applicable manufacturer did not require, 
instruct, or direct the organization to use the donation for grants 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 modifying the indirect 
payment exclusion at Sec.  403.904(i)(1).
    Comment: Many commenters interpreted the removal of physician 
speaker compensation at continuing education events would also remove 
the reporting exclusion for attendees at accredited or certified 
continuing education events whose fees have been subsidized through the 
continuing medical education organization by an applicable 
manufacturers.
    Response: We did not intend to remove the exclusion regarding 
subsidized fees provided to physician attendees by manufacturers at 
continuing education events. However, we intend for physician speaker 
compensation and physician attendees fees which have been subsidized 
through the continuing medical education organization by an applicable 
manufacturer to be reported unless the payment meets the indirect 
payment exclusion at Sec.  403.904(i)(1). This allows for consistent 
reporting for physician attendees and speakers at continuing education 
events. We will provide sub-regulatory guidance specifying tuition fees 
provided to physician attendees that have been generally subsidized at 
continuing education events by manufacturers 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 indirect payment exclusion only applies if the 
manufacturer did not know the identity of the physician attendee.
    Comment: Many commenters interpreted the proposed removal ofSec.  
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 ofSec.  
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 education 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 applicable manufacturers.
3. Reporting of Marketed Name (Sec.  403.904(c)(8))
    Section 1128G(a)(1)(A)(vii) of the Act requires applicable 
manufacturers to report the name of the covered drug, device, 
biological or medical supply associated with that payment, if the 
payment is related to ``marketing, education, or research'' of a 
particular covered drug, device, biological, or medical supply. Section 
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 Sec.  403.904(c)(8)(ii), we require an applicable 
manufacturer of devices or medical supplies to report one of the 
following: the marketed name; product category; or therapeutic area. In 
the February 8, 2013, final rule, we provided applicable manufactures 
with flexibility when it was determined that the marketed name for all 
devices and medical supplies may not be useful for the general 
audience. We did not define product categories or therapeutic areas in 
Sec.  403.904(c). However, since implementation 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, biologics, 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 Sec.  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 consistent reporting for the consumers and researchers using 
the data displayed publicly on the Open Payments. Manufacturers 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 regarding revising reporting 
requirements at Sec.  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 public is not familiar with device or medical supply 
marketed names. We also received a few comments that supported 
requiring the reporting of marketed name for devices and medical 
supplies. Supporting commenters believe that reporting marketed name 
for all products will allow the public (including researchers and 
consumers) to search the data via the Open Payments public Web site 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 manufacturers should not be required to report 
marketed names for non-covered products. Additionally, some comments 
indicated reporting marketed name for devices and medical supplies for 
research payments is not practical because there is not a marketed name 
for every device or medical supply associated with research payments; 
rather there may only be a connection to an associated research study. 
A few commenters addressed that manufacturers will have an increased 
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.

[[Page 67761]]

We have finalized a modified approach to accommodate concerns regarding 
reporting related covered drug, device, biological or medical supply 
information. We agree manufacturers should not be required to report 
marketed names for non-covered products; therefore, we are finalizing 
the proposal that reporting marketed names for non-covered drugs, 
devices, biologicals, or medical supplies will continue to be optional. 
We also agree a payment or other transfer of value associated with a 
research payment regarding a device or medical 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 marketed 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 the Open Payments public Web site because the public 
is not familiar with marketed names for devices and medical supplies. 
We agree therapeutic areas and products categories are more 
recognizable 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 reporting by manufacturers, we will require 
manufacturers to report marketed name and therapeutic area or product 
category for all covered drugs, devices, biologicals or medical 
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 
would begin January 1, 2016.
4. Reporting of Stock, Stock Option, or Any Other Ownership Interest
    Section 403.904(d)(3) requires the reporting of stock, stock 
option, or any other ownership interest. We proposed to require 
applicable manufacturers to report such payments as distinct 
categories. This will enable us to collect more specific data regarding 
the forms of payment made by applicable manufacturers. After 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, and 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 operational or other issues on the 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, requiring reporting of marketed name for covered devices and 
medical supplies, and whether this change presents operational or other 
issues on the part of applicable manufacturers.
    Comment: Commenters agreed that requiring reporting of stock, stock 
option or any other ownership interest in distinct categories is 
useful.
    Response: We agree the disaggregation of reporting stock, stock 
option or any other ownership interest in distinct categories. 
Therefore, we have finalized this provision as proposed, which requires 
reporting stock, stock option, or any other ownership interest form of 
payment or other transfer of value in distinct categories.

J. Physician Compare Web Site

1. Background and Statutory Authority
    Section 10331(a)(1) of the Affordable Care Act, requires that, by 
no later than January 1, 2011, we develop a Physician Compare Internet 
Web site with information on physicians enrolled in the Medicare 
program under section 1866(j) of the Act, as well as information on 
other eligible professionals (EPs) 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 
available 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 measures are developed and 
are available, we are required to include, to the extent practicable, 
the following types of measures for public reporting:
    <bullet> Measures collected under the Physician Quality Reporting 
System (PQRS).
    <bullet> An assessment of patient health outcomes and functional 
status of patients.
    <bullet> An assessment of the continuity and coordination of care 
and care transitions, including episodes of care and risk-adjusted 
resource use.
    <bullet> An assessment of efficiency.
    <bullet> An assessment of patient experience and patient, 
caregiver, and family engagement.
    <bullet> An assessment of the safety, effectiveness, and timeliness 
of care.
    <bullet> Other information as determined appropriate by the 
Secretary.
    As required under section 10331(b) of the Affordable Care Act, in 
developing and implementing the plan, we must include, to the extent 
practicable, the following:
    <bullet> Processes to ensure that data made public are 
statistically valid, reliable, and accurate, including risk adjustment 
mechanisms used by the Secretary.
    <bullet> Processes for physicians and eligible professionals whose 
information is being publicly reported to have a reasonable 
opportunity, as determined by the Secretary, to review their results 
before posting to Physician Compare. We have established a 30-day 
preview period for all measurement performance data that will allow 
physicians and other EPs to view their data as it will appear on the 
Web site in advance of publication on Physician Compare (77 FR 69166 
and 78 FR 74450). Details of the preview process will be communicated 
directly to those with measures to preview and will also be published 
on the Physician Compare Initiative page (http://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/physician-compare-initiative/) in advance of the preview period.
    <bullet> Processes to ensure the data published on Physician 
Compare provides a robust and accurate portrayal of a physician's 
performance.
    <bullet> Data that reflects the care provided to all patients seen 
by physicians, under both the Medicare program and, to the extent 
applicable, other payers, to the extent such information would provide 
a more accurate portrayal of physician performance.
    <bullet> Processes to ensure appropriate attribution of care when 
multiple physicians and other providers are involved in the care of the 
patient.
    <bullet> Processes to ensure timely statistical performance 
feedback is

[[Page 67762]]

provided to physicians concerning the data published on Physician 
Compare.
    <bullet> Implementation of computer and data infrastructure 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 sections 
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 variety of means, including 
rulemaking and different forms of stakeholder outreach (for example, 
Town Hall meetings, Open Door Forums, webinars, education and outreach, 
Technical Expert Panels, etc.). In developing the plan for making 
information on physician performance publicly available through 
Physician Compare, section 10331(e) of the Affordable Care Act requires 
the Secretary, as the Secretary determines appropriate, to consider the 
plan to transition to value-based purchasing for physicians and other 
practitioners that was developed under 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 
Compare 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 any 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 they provide to their patients. In accordance with section 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 Web site, we have continued to 
build on and improve Physician Compare. On June 27, 2013, we launched a 
full redesign of Physician Compare bringing significant improvements 
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 and 
the limitations of the search function--and considerably improving Web 
site functionality and usability. Provider Enrollment, Chain, and 
Ownership System (PECOS), as the sole source of verified Medicare 
professional information, is the primary source of administrative 
information on Physician Compare. With the redesign, however, we 
incorporated the use of Medicare Fee-For-Service claims information to 
verify the information in PECOS to help ensure only the most 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 the professional is currently 
providing services. Claims information helps confirm that only the 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 information available about the 
professionals for Medicare consumers.
    We received several comments about the enhancements made to the 
Physician Compare Web site and the data currently on the Web site.
    Comment: Several commenters noted the improvements made to the 
Physician Compare Web site, including the additional labeling, 
improvements to the ``Is this you?'' link, the reordering of the search 
results, the Intelligent Search functionality, the use of claims data 
to verify professionals' demographic information, denoting board 
certified physicians with contextual text, and explanations and 
disclaimers about each of the federal quality reporting programs 
included on the Web site. Commenters also noted an appreciation for the 
transparency and easy-to-use, comprehensive information available on 
the site to aid consumers in making informed health care decisions.
    Some commenters provided suggestions for future Physician Compare 
enhancements. A few commenters suggested continued improvements to the 
Intelligent Search functionality to better find health care 
professionals other than physicians and additional specialty labels for 
Advanced Practice Registered Nurses (APRNs) and allied health 
professionals.
    Response: We appreciate the commenters' feedback and the continued 
support for the Physician Compare Web site. We are committed to 
continuing to improve the site and its functionality to ensure it is a 
useful resource for Medicare consumers, 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 continually working to improve and 
enhance the Intelligent Search functionality.
    Comment: Some commenters expressed 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 Web site. 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 commenter cautioned against using PECOS for 
updating information. Several commenters suggested continuing to work 
with stakeholders, particularly health care professionals, and/or 
providing educational material regarding how to keep data current to 
ensure the accuracy of the Web site.
    Response: We appreciate the commenters' feedback regarding 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 therefore 
critical that physicians, 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. Currently, 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 reported 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.

[[Page 67763]]

    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 unfortunately results in a delay 
updating information. We are continually working to find ways 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 
<a href="/cdn-cgi/l/email-protection#a4f4ccddd7cdc7cdc5cae7cbc9d4c5d6c1e4f3c1d7d0c5d08ac7cbc9"><span class="__cf_email__" data-cfemail="cc9ca4b5bfa5afa5ada28fa3a1bcadbea98c9ba9bfb8adb8e2afa3a1">[email protected]</span></a>. Information regarding how to keep your 
information current can also be found on the Physician Compare 
Initiative page on CMS.gov (http://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/physician-compare-initiative/).
    Although we appreciate the concerns raised 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. However, 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 strongly encourage all 
professionals and group practices listed on the site to regularly check 
their data and to contact the support team with any questions or 
concerns.
    Currently, Web site users can view information about approved 
Medicare 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, and American Board of 
Medical Specialties (ABMS) board certification information. In 
addition, for group practices, users can also view group practice 
names, specialties, practice locations, Medicare assignment status, and 
affiliated professionals.
    We post on the Web site the names of individual 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 information 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 quality programs under which the EP 
satisfactorily or successfully reported. We proposed (79 FR 40386) to 
continue to include this information annually in the year following the 
year it is reported (for example, 2015 PQRS reporting will be included 
on the Web site in 2016). We did not receive any comments on this 
proposal. We are finalizing this proposal at this time, and therefore, 
will include satisfactory 2015 PQRS reporters on the Web site in 2016. 
The eRx Incentive Program 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 are satisfactorily reporting in the Group Practice 
Reporting Option (GPRO) under PQRS or are successful electronic 
prescribers under the eRx Incentive Program. We have also included a 
notation and check mark for individuals that successfully participate 
in the Medicare EHR Incentive Program, as authorized by section 
1848(o)(3)(D) of the Act. 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 Web site in 
2016).
    We did not receive any comments regarding our proposal regarding 
this PQRS GPRO. We are finalizing the proposal to include a notation 
for satisfactory PQRS GPRO reporters. As noted above, the eRx Incentive 
Program is ending in 2014, and therefore, there will not be data for 
this program in 2015 or beyond. We did receive comments regarding 
including a notation for individuals that successfully participate in 
the Medicare EHR Incentive Program.
    Comment: Two commenters urged CMS to reconsider 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 delays, concerns about the 
relevancy to consumers, and limited ability to implement core measures. 
One commenter suggested including a disclaimer next to the indicator 
explaining these barriers and clarifying that successful participation 
in the EHR Incentive Program is only one of various ways to demonstrate 
an investment in higher quality care.
    Response: We appreciate the commenters' feedback, and we will take 
the suggestions provided regarding a disclaimer into consideration for 
possible future enhancements. We also appreciate the concerns raised 
about the program, specifically around vendor certification and core 
measures. However, despite those potential 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 information 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 Web site.
    We previously finalized a decision to publicly report the names of 
those EPs who report the 2014 PQRS Cardiovascular Prevention measures 
group in support of Million Hearts on Physician Compare in 2015, by 
including a check mark 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 commenters supported our proposal to publicly report 
and include an indicator for EPs who report the 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' support. We agree that 
Million Hearts is an important initiative that is improving outcomes 
for cardiovascular health. However, we are finalizing the removal of 
the Cardiovascular Prevention measure group from the PQRS program given 
that the two cholesterol control measures included in the measure group 
are no longer clinically relevant, and therefore, the measure group no 
longer meets the necessary threshold for PQRS of six measures and will 
no longer be available for reporting under the program. With the 
removal of the 2 cholesterol control measures, the remaining measures 
from the original Cardiovascular Prevention measure group are:
    <bullet> Ischemic Vascular Disease (IVD): Use of Aspirin or Another 
Antithrombotic.
    <bullet> Preventive Care and Screening: Tobacco Use.

[[Page 67764]]

    <bullet> Controlling High Blood Pressure.
    <bullet> Preventive Care and Screening: Screening for High Blood 
Pressure and Follow-Up Documented.
    All of these measures are available as individual measures under 
PQRS. Given that the Cardiovascular Prevention measure group is being 
eliminated from the PQRS, but that the remaining measures identified 
above will be available 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 
reporting these quality measures as individual measures. Even though 
the individual measures require that a potentially 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 as currently 
available claims data show, significantly 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 important program 
despite the measure group no longer being available for reporting.
    Finally, we will also indicate with a green check mark those 
individuals who have earned the 2014 PQRS Maintenance of Certification 
Incentive (Additional Incentive) on the Web site in 2015 (78 FR 74450).
    Comment: Several commenters supported publicly reporting earners of 
the PQRS Maintenance of Certification (MOC) program Additional 
Incentive, as well as ABMS Board Certification data, while other 
commenters are concerned that ABMS data are not complete or only 
include some specialists. Multiple commenters suggested including other 
Boards' certifications and MOC programs, contextual certification 
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 certification and MOC program information on the Web site 
for possible inclusion in the future.
    We continue to implement our plan for a phased approach to public 
reporting performance information on Physician Compare. The 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 Web Interface for 2012 would be 
publicly reported on Physician Compare. The plan was expanded with the 
CY 2013 PFS final rule with comment period (77 FR 69166), where we 
established that the specific GPRO Web Interface measures that would be 
posted on Physician Compare would include the PQRS GPRO measures for 
Diabetes Mellitus (DM) and Coronary Artery Disease (CAD), and we noted 
that we would report composite measures for these measure 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 composites 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 the minimum threshold is not met for a 
particular measure, or the measure is otherwise deemed not to be 
suitable for public reporting, the group's performance rate on that 
measure will not be publicly reported. 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 Medicare professionals they choose to meet their 
health care needs.
---------------------------------------------------------------------------

    \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.
---------------------------------------------------------------------------

    Measures must be based on reliable and valid data elements to be 
useful to consumers and thus included on Physician Compare. A reliable 
data element is consistently measuring the same thing regardless of 
when or where it is collected, while a valid data element is measuring 
what it is meant to measure. To address the reliability of performance 
scores, we will measure the extent to which differences in each quality 
measure are due to actual differences in clinician performance versus 
variation that arises from measurement error. Statistically, 
reliability depends on performance variation for a measure across 
clinicians (``signal''), the random variation in performance for a 
measure within a clinician's panel of attributed beneficiaries 
(``noise''), and the number of beneficiaries attributed 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 another. 
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 variation is a result of 
measurement error. Reliability testing methods included in the CMS 
Measures Management System Blueprint (https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/MMS/MeasuresManagementSystemBlueprint.html) include test-retest reliability 
and analysis of variance (ANOVA). Reliability tests endorsed by the NQF 
include the beta-binomial model test.
    The validity of a measure refers to the ability to record or 
quantify what it claims to measure. To analyze validity, we can 
investigate the extent to which each quality measure is correlated with 
related, previously validated, measures. 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. Therefore, 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, the previously validated measure should measure 
a health outcome related to the outcome of interest.
    Comment: Many commenters supported only publishing on Physician

[[Page 67765]]

Compare those measures that are statistically valid and reliable. 
Several commenters urged CMS to carefully assess if all GPRO measure 
data is sufficiently reliable and valid for public reporting before 
posting the data. One commenter recommended removing any measures 
deemed unreliable or inaccurate. One commenter recommended a one-year 
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 results of validity and 
reliability studies, as well as the methodology for choosing measures 
prior to posting on Physician Compare. Another commenter is concerned 
that measures related to patient behavior, preferences, or abilities do 
not provide a statistically valid portrayal of a health care 
professional'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' feedback, 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 Physician Compare, we must include, to the extent 
practicable, processes to ensure that the data posted on the Web site 
are statistically valid, reliable, and accurate, including risk 
adjustment mechanisms 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 assisting them in making 
informed health care decisions, while being accurate, valid, reliable, 
and complete. We will closely evaluate all quality measures under 
consideration for public reporting on the Web site 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 find a measure 
meeting the minimum threshold to be invalid or unreliable for any 
reason, the measure will not be reported. We are also making changes in 
light of the concerns about first year measures. We will not publicly 
post measures that are in their first year given the concerns raised 
about their validity, reliability, accuracy, and comparability. After a 
measure's first year in the program, CMS will evaluate the measure to 
see if and when the measure is suitable for pubic reporting. Also, we 
will continue to analyze the measure data to ensure that risk 
adjustment concerns are taken into consideration. All data are analyzed 
and reviewed by our Technical Expert Panel (TEP). A summary of the TEP 
recommendations is made public on the Physician Compare Initiative page 
(http://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/physician-compare-initiative/Informational-Materials.html) 
when available.
    In the November 2011 Medicare Shared Savings Program final rule (76 
FR 67948), we noted that because Accountable Care Organization (ACO) 
providers/suppliers that are EPs are considered to be a group practice 
for purposes of qualifying for a PQRS incentive under the Shared 
Savings Program, we would publicly report ACO performance on quality 
measures on Physician Compare in the same way as we report 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 measures was also published on the Web site in 
February 2014. ACO measures can be viewed by following the link for 
Accountable Care Organization (ACO) Quality Data on the homepage of the 
Physician Compare Web site (http://medicare.gov/physiciancompare/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 the decision to publicly report Clinician and Group 
Consumer Assessment of Healthcare Providers and Systems (CG-CAHPS) 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 posting these 
data on Physician Compare in late 2014, if available.
    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 the PQRS GPRO and for ACOs participating in 
the Medicare Shared Savings Program would be available for public 
reporting in CY 2015. As with all measures we finalized with regard to 
Physician Compare, these data would include measure performance rates 
for measures reported that meet 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 Physician 
Compare. This will allow 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 period. ACOs will be able to view their quality data 
that will be publicly reported on Physician 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 practices 
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 available for public 
reporting via the Web Interface. We will indicate the mechanism by 
which these data were collected and only those data deemed 
statistically comparable, valid, and reliable would be published on the 
site.
    We also finalized publicly reporting patient experience survey-
based measures from the CG-CAHPS measures for groups of 100 or more 
eligible professionals who participate in PQRS GPRO, regardless of GPRO 
submission method, and for Shared Savings Program ACOs reporting 
through the GPRO Web Interface or other CMS-approved tool or interface 
(78 FR 74452). For 2014 data, we finalized publicly reporting 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 regardless 
of PQRS participation, as technically feasible. For ACOs participating 
in the Shared 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 reporting 2014 PQRS measure 
data

[[Page 67766]]

reported by individual EPs in late CY 2015 for individual PQRS quality 
measures specifically identified in the final rule with comment period, 
if technically feasible. Specifically, we finalized to make available 
for public reporting 20 individual measures collected through a 
registry, EHR, or claims (78 FR 74453-74454). These are measures that 
are in line with those measures reported by groups via the GPRO Web 
Interface.
    Finally, in support of the HHS-wide Million Hearts Initiative, we 
finalized a decision to publicly report, no earlier than CY 2015, 
performance rates on measures in the PQRS Cardiovascular Prevention 
measures group at the individual 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.

[[Page 67767]]

[GRAPHIC] [TIFF OMITTED] TR13NO14.064


[[Page 67768]]


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 Web site. We started the phased approach with a 
small number of possible PQRS GPRO Web Interface measures for 2012 and 
have been steadily building on this to provide Medicare consumers with 
more information to help them make informed health care decisions. As a 
result, we proposed (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 concerned 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 
both patients and health care professionals. A few commenters were 
unsure if CMS conducted analysis of consumer use of the site and urged 
CMS to do so. Other commenters opposed the extensive expansion until 
existing Web site 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 
the 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 Interface 
measures (77 FR 69166). We started to build on this plan with the 2014 
Physician Fee Schedule (PFS) final rule (78 FR 74446). This rule made 
additional PQRS GPRO measures available for public reporting, including 
a subset of measures reported via Registry and EHR, as well as a sub-
set of 20 individual EP PQRS measures. Therefore, the proposals put 
forth this year are just the next step in the process to realize goals 
for authorization of Physician Compare. We are confident that taking 
this phased approach has afforded us the opportunity to prepare for 
this significant expansion.
    Throughout this process, we have been engaging 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 Web site and the administrative 
and demographic information included. We continue to encourage 
physicians, 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 available on Physician Compare. We also 
encourage individuals and groups to reach out to the Physician Compare 
support team at <a href="/cdn-cgi/l/email-protection#63330b1a100a000a020d200c0e13021106233406101702174d000c0e"><span class="__cf_email__" data-cfemail="47172f3e342e242e262904282a37263522071022343326336924282a">[email protected]</span></a> for any questions or 
concerns regarding the information included on the Web site.
    We proposed (79 FR 40388) to expand public reporting of group-level 
measures by making all 2015 PQRS GPRO measure 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 
included on the Web site.
---------------------------------------------------------------------------

    \7\ Tables Q1-Q27 detail proposed changes to available PQRS 
measures. Additional information on PQRS measures can be found on 
the CMS.gov PQRS Web site at http://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/PQRS/index.html.
---------------------------------------------------------------------------

    Comment: Commenters were both positive and negative in regard to 
our proposal to expand the group-level measures available for public 
reporting to all measures reported under 2015 PQRS GPRO. Commenters in 
support of the proposal noted group-level measures are a robust 
indication of care team quality and helpful 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 availability of the PQRS 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 
Registry 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 accurately 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, groups 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 reported in the first year, we have decided that 
we will not publicly report a measure that is in its first year. By 
first year we mean a measure that is newly available for reporting 
under PQRS.
    We also received comments specifically about EHR measures.
    Comment: Commenters were opposed to publicly reporting EHR 
measures, citing that it is too soon to publicly post performance data 
from eCQMs without additional work to verify the validity and accuracy 
of the measure results. One commenter suggested that new quality 
measures could be piloted by health care professionals prior to 
requiring their use within a federal program. One commenter strongly 
encouraged developing a tutorial 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 the 
ability to report measures via an EHR prior the 2015 data collection. 
Therefore, this reporting mechanism will not be in its first year of 
use at this time. As a result, we do not believe it is too soon to 
report these quality measures. As noted, only comparable, valid, 
reliable, and accurate

[[Page 67769]]

data will be included on Physician Compare. All measures slated for 
public reporting will be consumer tested to ensure they are accurately 
understood prior to publication. If concerns surface from this testing, 
we will evaluate if the requirements for public reporting are not 
suitably met 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 quality 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 proposal to 
report all 2015 PQRS measures for all reporting options for group 
practices of 2 or more EPs participating in PQRS GPRO, and all 2015 
measures reported by ACOs. Consistent with this final policy, we are 
making a conforming change to the regulation at Sec.  425.308(e) to 
provide that all quality measures reported by ACOs will be reported on 
Physician Compare in the same way as for 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 recommended CMS use a higher threshold to ensure 
validity. Several commenters also urged CMS to test 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 understand 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 patient privacy for reporting on the Web site, and aligns with 
the reliability threshold previously finalized for the Value-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 professionals, we are finalizing a patient sample size of 
20 patients.
    We proposed to include an indicator of which reporting mechanism 
was used and to only include on the site measures deemed statistically 
comparable.\8\ We received several comments regarding data 
comparability, generally.
---------------------------------------------------------------------------

    \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.
---------------------------------------------------------------------------

    Comment: Some commenters expressed concern with the comparability 
of measures reported through different reporting mechanisms and 
requested notation specifying the measure differences. One commenter 
supported only publicly reporting measures with specifications 
consistent across all reporting mechanisms, while another commenter 
recommended that CMS group results by the data collection methodology 
to improve comparability.
    Response: Though we understand concerns regarding including 
measures collected via different mechanisms, CMS is conducting analyses 
to ensure that these 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, then 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 proven to be comparable and most suitable for 
public reporting will be included on Physician Compare and made 
publicly available. Therefore, we are finalizing our proposal to report 
data from the available reporting mechanisms and to include a notation 
indicating which reporting 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 decisions. Our analysis of the collected measure data, 
along with consumer testing and stakeholder feedback, will determine 
specifically which measures are published on profile pages on the Web 
site. Statistical analyses will ensure the measures included are 
statistically valid and reliable and comparable across data collection 
mechanisms. Stakeholder feedback will ensure all 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 consideration for public reporting remain clinically 
relevant and accurate. When measures are finalized significantly in 
advance of moment they are collected, it is possible that clinical 
guidelines can change rendering a measure no longer relevant. 
Publishing that measure can lead to consumer confusion 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 informed health care 
decisions. If a consumer does not properly interpret a quality measure 
and thus misunderstands 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 their 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 consumers, thus helping them make 
informed decisions. This will be done to ensure that the information 
included on Physician Compare is consumer friendly 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 Web site. One commenter further emphasized CMS should create 
consistent formatting with Hospital Compare downloadable files.
    Response: We appreciate the commenters' feedback and support for 
this proposal. We are finalizing the proposal to include all measures 
in a downloadable file and limiting the measures available on Physician 
Compare profile pages to those measures that not only meet the 
requirements of public reporting such as validity, reliability, 
accuracy, and comparability, but that also are accurately understood 
and interpreted by consumers as evidenced via consumer testing. This 
will ensure that the measures presented on Physician Compare help them 
make informed health care decisions without overwhelming them with too 
much information. We will also take into future consideration the

[[Page 67770]]

recommendation regarding the Hospital Compare file.
    We also received comments regarding stakeholder involvement and 
consumer testing.
    Comment: Commenters encouraged continued involvement of measure 
developers and stakeholders in the public reporting development 
process. Several commenters appreciated the continued collaboration 
with specialty societies via town hall meetings and other mechanisms. 
Several commenters advocated for more transparency by providing the 
opportunity for the public to comment on the deliberations of the 
Physician Compare TEP; regular engagement with interested stakeholders; 
and increased communication about the measure consideration process, 
including methods and interpretation of performance. Some commenters 
appreciated that CMS will continue to reach out to stakeholders in the 
professional community to ensure that the measures under consideration 
for public reporting remain clinically relevant and accurate. One 
commenter suggested an opportunity for stakeholder associations to 
participate in the 30-day measure preview process.
    Response: We appreciate the commenters' feedback regarding 
stakeholder outreach and involvement in Physician Compare. As we noted, 
section 10331(d) of the Affordable Care Act requires that the Secretary 
take into consideration 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 for 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 recommendations 
provided for future consideration.
    Comment: Many commenters supported consumer testing to ensure only 
meaningful measures are included on the site. One commenter suggested 
CMS first focus on communicating validated and meaningful information 
in a user-friendly way. One commenter urged CMS to consult a broader 
array of stakeholders during concept testing, while another commenter 
specified the inclusion of health care professionals. Some commenters 
requested that CMS share with professional associations or measure 
developers any information obtained through consumer concept testing. A 
few commenters asked for more details on concept testing plans, while 
another recommended CMS use concept testing for the information 
currently on the Physician Compare. One commenter emphasized testing 
must occur prior to placing these additional measures on the Web site 
in late 2016. One commenter believed health care professionals must be 
aware of what measures will be reported to the Physician Compare Web 
site 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 Web site and that information included 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 Web site with site users. We are planning concept 
testing of the measures being finalized in this rule prior to 
publication in 2016 and we will work to ensure that valid, reliable, 
and meaningful information is included on the Web site. 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 feedback, including input from 
the public, consumers, and health care professionals, as appropriate 
and feasible through such opportunities as Town Halls, Listening 
Sessions, Open Door Forums, and Webinars. We will review feedback for 
future consideration. Although we establish in rulemaking the subset of 
measures available for posting on the Physician Compare Web site, at 
this time, however, it is not possible for us to provide stakeholders 
with the exact list of measures that will be included on the Web site 
prior to our analysis of the reported data 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 
measures as they will appear on Physician Compare prior to the measures 
being published. As in previous years, 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 period. ACOs will be 
able to view their quality data that will be publicly reported on 
Physician 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.
    Comment: Several commenters were in support of the 30-day preview 
period prior to publication of quality data. Many commenters urged CMS 
to also allow group practices, ACOs, and EPs the opportunity to correct 
and/or appeal any errors found in the performance information before it 
is posted on the Web site. Several commenters recommended CMS postpone 
posting information if a group practice or EP files an appeal and flags 
their demographic data or quality information as problematic. Other 
commenters noted 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 clarification on 
how CMS plans to notify EPs of the preview period and requested more 
detail about correcting errors found during the preview period.
    Response: We appreciate the commenters' feedback regarding the 30-
day preview period for quality measures on Physician Compare. Detailed 
instructions regarding how to preview measure data, the time frame for 
the measure preview, and directions for how to address any concerns or 
get additional help during this process is shared at the start of the 
preview period with all groups and individuals that 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 email to have concerns addressed. Errors will be 
corrected prior to publication. If measure data has 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 
demonstrates 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 and relevant as possible when 
published. 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

[[Page 67771]]

or have questions answered. Additionally, information 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. 
These data are currently publicly available. If a group practice or EP 
has questions about their demographic data, they should contact the 
Physician Compare support team at <a href="/cdn-cgi/l/email-protection#3c6c54454f555f555d527f53514c5d4e597c6b594f485d48125f5351"><span class="__cf_email__" data-cfemail="0b5b6372786268626a654864667b6a796e4b5c6e787f6a7f25686466">[email protected]</span></a>.
    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 indicated we would analyze the data collected in 2015 and 
conduct psychometric and statistical analyses, looking at how the 
measures best fit together and how accurately they are measuring the 
composite concept, to create composites for certain PQRS GPRO measure 
groups, including but not limited to:
    <bullet> Care Coordination/Patient Safety (CARE) Measures
    <bullet> Coronary Artery Disease (CAD) Disease Module
    <bullet> Diabetes Mellitus (DM) Disease Module
    <bullet> Preventive (PREV) Care Measures
    In particular, we would analyze the component measures that make up 
each of these measure groups to see if a statistically viable composite 
can be constructed with the data reported for 2015. Composite scores 
have proven to be beneficial in providing consumers 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 
statistically 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 components 
and composites before finalizing any composites. Several commenters 
strongly urged CMS to seek input from relevant specialty societies, 
measure developers, consumers, and other stakeholders on the 
construction and display of the composites. A few commenters opposed 
public reporting of composites, but suggested providing physicians the 
composite scores confidentially through the QRURs. Several commenters 
noted concerns about the proposal to create composites 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 to 
composites in relatively small and heterogeneous measure sets. A few 
commenters suggested posting additional information about composite 
measures 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 information about the measures 
within each composite measure in the downloadable file. One commenter 
does not specifically support the Oncology Composite Score on Physician 
Compare.
    Response: We appreciate the commenters' feedback 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 future rulemaking. This concept was put forth merely to 
seek comment and no formal proposal 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 appropriately understood. A benchmark will 
allow consumers to more easily evaluate the information published by 
providing a point of comparison between groups. We continue to receive 
requests from all stakeholders, but especially consumers, to add this 
information to Physician Compare. As a result, we proposed (79 FR 
40389) to publicly report on Physician 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 rule with comment period 
(78 FR 74759). Details on this methodology can be found on CMS.gov at 
http://cms.gov/Medicare/Medicare-Fee-for-Service-Payment/sharedsavingsprogram/Downloads/MSSP-QM-Benchmarks.pdf. We proposed to 
follow this methodology using the 2014 PQRS GPRO data.
    We proposed to calculate benchmarks using data at the group 
practice TIN level for all EPs who have at least 20 cases in the 
denominator. A benchmark per this methodology is the performance rate a 
group practice must achieve to earn the corresponding quality points 
for each measure. Benchmarks would be established for each percentile, 
starting with the 30th percentile (corresponding to the minimum 
attainment level) 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 quality points on a sliding scale based on level of 
performance: performance below the minimum attainment level (the 30th 
percentile) for a measure would receive zero points for that measure; 
performance at or above the 90th percentile of the performance 
benchmark would earn the maximum 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 together to generate a final overall quality 
score for each group practice. The goal of including such benchmarks 
would be to help consumers see how each group practice performs on each 
measure, measure 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, several 
commenters did not support the calculation of an overall quality score, 
as they believe it will 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 consumer testing to remedy this problem. Some commenters 
noted appropriate methodology is needed when potential data constraints 
impact the calculation of benchmarks. Several commenters also asked for

[[Page 67772]]

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 data 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 whether the benchmarking 
methodology would be the same as the methodology applied under the 
Value-Modifier. Several commenters urged CMS to use consistent 
benchmarking across its programs to promote consistency and minimize 
confusion. One commenter 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 current 
Shared Savings Program benchmark methodology. Although we agree 
benchmarks can add 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 finalizing the proposal. We also want to evaluate other 
programs' methodologies, including the Value Modifier, to work toward 
better alignment across programs. We therefore feel it would be best to 
forgo finalizing a methodology at this time in favor of a stronger, 
potentially better aligned methodology that can be included in future 
rulemaking.
    Understanding the value consumers place on patient 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 all group practices of two or more EPs, who meet the 
specified sample size requirements and collect data via a CMS-specified 
certified CAHPS vendor. The patient experience data available are 
specifically the CAHPS for PQRS and CAHPS for ACO measures, which 
include the CG-CAHPS core measures. For group practices, we proposed to 
make available for public reporting these 12 summary survey measures:
    <bullet> Getting Timely Care, Appointments, and Information.
    <bullet> How Well Providers Communicate.
    <bullet> Patient's Rating of Provider.
    <bullet> Access to Specialists.
    <bullet> Health Promotion & Education.
    <bullet> Shared Decision Making.
    <bullet> Health Status/Functional Status.
    <bullet> Courteous and Helpful Office Staff.
    <bullet> Care Coordination.
    <bullet> Between Visit Communication.
    <bullet> Helping You to Take Medication as Directed.
    <bullet> Stewardship of Patient Resources.
    We proposed that these 12 summary survey measures would be 
available for public reporting for all group practices. For ACOs 
participating in the Shared Savings Program, we proposed (79 FR 40390) 
that the patient experience measures that are included in the Patient/
Caregiver Experience domain of the Quality Performance Standard under 
the Shared Savings Program in 2015 would be available for public 
reporting in 2016. We would review all quality measures after they are 
collected to ensure that only those measures deemed valid and reliable 
are included on the Web site.
    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-approved vendor. One commenter strongly encouraged CMS to make 
public reporting on patient experience measures mandatory for groups of 
all sizes and individual EPs. However, a few commenters were concerned 
with 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 the concerns raised regarding subjectivity and 
cost. However, we are confident that CAHPS is a well-tested collection 
mechanism that produces valid and comparable measures of physician 
quality based on the extensive testing and work that has been done by 
the Agency for Healthcare Research and Quality's (AHRQ) and 
specifically the CAHPS Consortium (for more information 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 concerns regarding cost are 
outweighed. For these reasons, we are finalizing our proposal to make 
available for public reporting the 12 summary survey CAHPS measures 
outlined in this rule on Physician Compare for group practices and 
ACOs, as appropriate.
    Comment: Commenters were generally supportive of the proposal to 
publicly report 12 summary CAHPS scores; however, some are concerned 
that several CAHPS summary survey measures cannot accurately capture 
aspects of care over which an individual physician does not have direct 
control, such as ``Getting Timely Care, Appointments and Information'' 
and ``Access to Specialists,'' and urged CMS to only report these 
measures on an aggregate, group level. Another commenter is concerned 
with ``Stewardship of Patient Resources'' survey measure, noting that 
it is not a physician's role to manage a patient's pocketbook and that 
other barriers, apart from costs, can impede access to care.
    One commenter supported the creation of benchmarks 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 commenters' feedback regarding concerns 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 accurately interpreted by 
consumers. If a summary survey measure does not meet these criteria, it 
will not be publicly reported on Physician Compare. At this time, we 
are not adopting any benchmarks for CAHPS for PQRS on Physician 
Compare.
    Comment: One commenter sought additional information on how CAHPS 
for PQRS performance measures will be displayed. Another commenter 
suggested that public reporting of

[[Page 67773]]

CAHPS for PQRS utilize the Hospital Compare model by displaying 
aggregate scores for measures with a footnote or click-through option 
to view the performance data.
    Response: We appreciate the commenters' feedback regarding display 
of CAHPS for PQRS measures. We generally make decisions about measure 
display after consumer testing and stakeholder outreach, so we will 
take these recommendations into consideration.
    We previously finalized in the 2014 PFS final 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. First, 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 looking for measures 
about individual doctors and other health care professionals, and this 
would make these quality data available to the public sooner.
    Comment: One commenter supported our proposal to publicly report 20 
individual EP-level 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 needed to be finalized 
before the public reporting period had ended.
    Response: We appreciate the commenters' feedback and understand 
concerns that the 2013 individual EP PQRS data were submitted without 
an explicit understanding 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 available for 
public reporting on Physician Compare for data collected in 2015 to be 
publicly reported 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 
information to consumers to make informed decisions about their health 
care. As with group-level measures, we proposed to publicly report all 
measures submitted and reviewed and deemed valid and reliable in the 
Physician Compare downloadable file. However, not all of these measures 
necessarily 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 specifically which measures 
are published on profile pages on the Web site. In this way, quality 
information on individual practitioners would be available, as has been 
regularly requested by Medicare consumers, without overwhelming 
consumers with too much information.
---------------------------------------------------------------------------

    \9\ Tables Q1-Q27 detail proposed changes to available PQRS 
measures. Additional information on PQRS measures can be found on 
the CMS.gov PQRS Web site at http://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/PQRS/index.html.
---------------------------------------------------------------------------

    Comment: Some commenters supported expanding public reporting of 
individual-level quality measures to all 2015 PQRS measures collected 
through a Registry, EHR, or claims, noting consumers are looking for 
individual doctors so this information 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 too much 
information for consumers. One commenter stated that data reported 
through different reporting mechanisms is not comparable so this 
proposal should not be finalized. One commenter believed that the 
relatively small numbers of patients seen by individual physicians 
raises questions about the ability to truly differentiate quality. 
Several commenters supported group practice level public reporting as 
an alternative to individual public reporting.
    Response: We appreciate the commenters' feedback and agree 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 commenters that these data will help 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 concerns 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 Web site those measures that 
resonate with consumers 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 sample 
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 finalizing our proposal to publicly 
report all 2015 individual EP PQRS measures collected through a 
Registry, EHR, or claims, except for those measure that are new to PQRS 
and thus in their first year.
    As noted above for group-level reporting, composite scores and 
benchmarks are critical in helping consumers best understand the 
quality measure information presented. For that reason, in addition to 
making all 2015 PQRS measures available for public reporting, we sought 
comment (79 FR 40390) to create composites and publish composite scores 
by grouping measures based on the PQRS measure groups, if technically 
feasible. We indicated that we would analyze the data collected in 2015 
and conduct psychometric and statistical analyses to create composites 
for PQRS measure groups to be published in 2016, including:
    <bullet> Coronary Artery Disease (CAD) (see Table 30)
    <bullet> Diabetes Mellitus (DM) (see Table 32)
    <bullet> General Surgery (see Table 33)
    <bullet> Oncology (see Table 38)
    <bullet> Preventive Care (see Table 41)
    <bullet> Rheumatoid Arthritis (RA) (see Table 42)
    <bullet> Total Knee Replacement (TKR) (see Table 45)
    We would analyze the component measures that make up each of these 
measure groups to see if a statistically viable composite can be 
constructed with the data reported for 2015. As noted for group 
practices, we believe that providing composite scores will give 
consumers the tools needed to most accurately interpret the quality 
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 constructed 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 
comments are addressed above. Since we were only seeking

[[Page 67774]]

comments on possible future composites, we are not finalizing any at 
this time, but we will take those comments into consideration for the 
future.
    In addition, we proposed (79 FR 40390) to use the same methodology 
outlined above for group practices to develop benchmarks for individual 
practitioners. We believe that providing benchmarks will give consumers 
the tools needed to most accurately interpret the quality data 
published on Physician Compare. As discussed above, we received 
comments on the proposed benchmarking methodology for both group 
practices and individual EPs. Those comments were previously addressed. 
As noted, we are not finalizing this proposed benchmarking methodology 
at this time.
    Previously, we indicated an interest in including specialty society 
measures on Physician Compare. In the proposed rule, we solicited 
comment (79 FR 40390) on posting these measures on the Web site. We 
also solicited comment on the option of linking from Physician Compare 
to specialty society Web sites that publish non-PQRS measures. 
Including specialty society measures on the site or linking to specific 
specialty society measures would provide the opportunity for more 
eligible professionals to have measures included on Physician Compare 
and thus help Medicare consumers make more informed choices. The 
quality measures developed by specialty societies that would be 
considered for future posting on Physician Compare are those that have 
been comprehensively vetted and tested and are trusted by the physician 
community. These measures would provide access to available specialty 
specific quality measures that are often highly regarded and trusted 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 specific society measures of interest.
    Comment: Many commenters supported specialty society measures on 
Physician Compare or linking to specialty society Web sites that 
publish non-PQRS measures. Several commenters specified that the 
specialty society measures should be supported by scientific evidence, 
developed by relevant clinical experts, and adequately vetted. Some 
commenters suggested a disclaimer specifying, along with the measure 
description, the limitations of PQRS or clarification that CMS is not 
endorsing and has not validated specialty society measures. One 
commenter supported specialty measures as long as data is open sourced, 
provided at no cost, and made available to all. One commenter suggested 
also including links to additional patient-friendly educational 
materials on specialty societies' Web sites.
    Several commenters opposed posting non-PQRS data or linking to non-
governmental, privately managed Web sites. One commenter stated CMS 
should maintain control over the public disclosure process to reduce 
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 measures that 
are meaningful to consumers and comparable to those reported upon under 
the PQRS. A few commenters sought additional information on this 
process if this becomes a formal proposal in future years.
    Response: We appreciate commenters' feedback on our request for 
information. We were only seeking comment at this time. We will 
consider feedback, recommendations made, and concerns raised, and may 
consider addressing specialty society measures and Web site links on 
Physician Compare in future rulemaking.
    Finally, we proposed (79 FR 40390) to make available on Physician 
Compare, 2015 Qualified Clinical Data Registry (QCDR) measure data 
collected at the individual level or aggregated to a higher level of 
the QCDR's choosing--such as the group practice level, if technically 
feasible. QCDRs are able to collect both PQRS measures and non-PQRS 
measures.\10\ We believe that making QCDR data available on Physician 
Compare further supports the expansion of quality measure data 
available for EPs and group practices regardless of specialty therefore 
providing more quality data to consumers to help them make informed 
decisions. Per the proposal, the QCDR would be required to declare 
during their self-nomination if they plan to post data on their own Web 
site and allow Physician Compare to link to it or if they will provide 
data to CMS for public reporting on Physician Compare. We proposed that 
measures collected via QCDRs must also meet the established public 
reporting criteria, including a 20 patient minimum sample size. As with 
PQRS data, we proposed to publicly report in the Physician Compare 
downloadable file all measures submitted, reviewed, and deemed valid 
and reliable. However, not all of these measures necessarily 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 specifically which measures are published on 
profile pages on the Web site.
---------------------------------------------------------------------------

    \10\ http://www.cms.gov/apps/ama/license.asp?file=/PQRS/downloads/2014_PQRS_IndClaimsRegistry_MeasureSpecs_SupportingDocs_12132013.zip
---------------------------------------------------------------------------

    Comment: We received many comments on publicly reporting 2015 QCDR 
measure data. Some commenters supported publicly reporting 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 first year data for 
new measures would be problematic. Other commenters opposed publicly 
reporting QCDR data until accurate benchmarking data can be developed, 
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 CMS develop rules and 
guidelines for measure stewards who develop non-PQRS measures housed in 
QCDR's. One commenter stated society-sponsored non-PQRS measures need 
to be subjected to the same reliability, validity, and consumer testing 
that CMS promises for other information on Physician Compare. Another 
commenter noted that QCDR measures are collected 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 the 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

[[Page 67775]]

reporting we have set out, the measures will not be publicly reported. 
Regarding the comment that QCDR data should not be publicly reported 
until accurate benchmarks are available, we appreciate this concern but 
are moving forward with the proposal because we believe that even 
without benchmarks, these data can provide consumers with very valuable 
and instructive information as is the case, and thus consistent, with 
the PQRS measures we are finalizing for publication without a 
benchmark. We do feel it is important to include QCDR data in our 
public reporting plan, as some commenters agreed, because using QCDR 
data can ultimately provide an opportunity to have measures available 
for public reporting for a greater number of health care professionals 
covering more specialties, providing more and more useful information 
to health care consumers. We are therefore finalizing our proposal to 
publicly report QCDR measures with some modifications.
    We agree that it may be problematic to publicly report first year 
measures. Health care professionals should be afforded the opportunity 
to simply learn from the first year data, and not have this information 
shared publicly until the measure can be vetted for accuracy. As a 
result, 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 posted on Physician Compare 
when they mature.
    Comment: A number of commenters considered the proposed timeline 
for publicly reporting 2015 QCDR measure data too aggressive to ensure 
that data 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 concerned 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 this will 
streamline the public reporting process. One commenter noted that QCDRs 
Web sites are not intended for public consumption and would require new 
infrastructure, while another commenter was concerned with a potential 
conflict of interest by linking to nongovernmental Web sites. Two 
commenters support linking to the QCDR Web sites to view the data to 
reduce consumer confusion. Another commenter urged consistent and 
uniform public reporting.
    Response: We appreciate the commenters' feedback and do acknowledge 
the concerns regarding the timeline. To mitigate some of these 
concerns, we are adopting some refinements to what we proposed, such as 
not reporting first year measures. We believe that not publicly 
reporting measures on Physician Compare that are not ready for public 
reporting will help QCDRs early in their development and not reflect 
negatively on the new QCDR. We are also finalizing a decision to 
publish QCDR 2015 data on the Physician Compare Web site in 2016. 
However, as finalized in the PQRS section of this rule, we are not 
requiring these data to be publicly reported on the QCDR Web sites in 
order to address concerns that there is not enough time for QCDRs to 
establish user-friendly Web sites 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 Web site 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 reporting 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 level. 
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 publicly 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 will 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 enable us to review and 
vet the QCDR measures prior to public reporting in 2016. In this way, 
we can ensure only the most appropriate available QCDR measures are 
publicly reported, and that they are reported 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 data. However, QCDR data is not necessarily aggregated to a level 
consistent with how PQRS defines a group practice. Therefore, 
aggregated data cannot be accommodated on Physician Compare at this 
time. And, under PQRS, only individual EPs can report via a QCDR. 
Therefore, only including individual-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 Web 
site.
    Table 49 summarizes the Physician Compare proposals we are 
finalizing for with regard to 2015 data.

                            Table 49--Summary of Finalized Data for Public Reporting
----------------------------------------------------------------------------------------------------------------
                                                                                           Finalized proposals
                                  Publication                                               regarding quality
      Data collection year            year          Data type       Reporting mechanism   measures and data for
                                                                                             public reporting
----------------------------------------------------------------------------------------------------------------
2015............................         2016  PQRS, PQRS GPRO,     Web Interface, EHR,  Include an indicator
                                                EHR, and Million     Registry, Claims.    for satisfactory
                                                Hearts.                                   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      Web Interface, EHR,  All 2015 PQRS GPRO
                                                GPRO.                Registry, and        measures reported via
                                                                     Administrative       the Web Interface,
                                                                     Claims.              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.

[[Page 67776]]

 
2015............................         2016  CAHPS for PQRS&      CMS-Specified        2015 CAHPS for PQRS for
                                                CAHPS for ACOs.      Certified CAHPS      groups of 2 or more
                                                                     Vendor.              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    All 2015 PQRS measures
                                                                     Claims.              for individual EPs
                                                                                          collected through a
                                                                                          Registry, 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 availability of measures at the 
individual and group-levels for certain types of specialties and for 
other health care professionals, but that were beyond the scope of this 
rule. We have summarized and addressed those comments below.
    Comment: Several commenters are concerned about the availability of 
specialty-specific and non-physician measures available for public 
reporting due to the proposed removal of PQRS measures and/or 
limitations of measures reported via claims or the Web Interface. Two 
commenters noted that some specialty specific measures are not suitable 
for public reporting, as the data is not meaningful to consumers. 
Commenters also noted that the absence of measure data on Physician 
Compare due to limited available 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. Two commenters 
supported the continued work of CMS with professional societies to 
address measure concerns.
    Response: We appreciate the commenters' feedback. 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 QCDR measures and patient experience measures, will 
help mitigate concerns regarding quality data availability in the short 
term. And, it is important to realize that as most searches on 
Physician Compare are specialty based, if there are not measures for a 
given specialty, users will not be evaluating some physicians or non-
physicians with measures and some without within that specialty. That 
can also work to mitigate these concerns. Finally, we also understand 
that disclaimers and other types of explanatory language are necessary 
to help inform health care consumers as they use the Web site. We will 
continue to work to ensure that the language 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 not have quality data on the Web site.
    Comment: We received comments on how quality measures are displayed 
on Physician Compare. Several commenters opposed star rankings or 
similar systems and are concerned that disparate quality scores will 
result in inappropriate distinctions of quality for physicians whose 
performance scores are not statistically different. One commenter 
suggested increased efforts to establish the best method for presenting 
performance information to consumers and to educate consumers on the 
meaning of performance differences.
    Response: At the time this rule is finalized, 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. Performance scores 
are displayed visually using five stars as a pictographic 
representation of the percent. 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 Web site users. Stakeholders were 
provided opportunities to view alternate display 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 data 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 Physician 
Compare, noting that the name of the site could be more inclusive of 
all eligible health care professionals. One commenter suggested 
providing information throughout the Web site about the full array of 
qualified professionals. One commenter requested the definition of the 
Clinical Nurse Specialist change, while another specified changes for 
Registered Dietitian/Nutrition 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 
recommendations 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 always 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 update 
as appropriate.
    Comment: Commenters provided suggestions for additional information 
to publicly report on Physician Compare, including participation in a 
quality improvement registry for certain services, fellowship status, 
other voluntary quality improvement initiatives, educational materials 
about a disease or procedure, specialist-specific training and 
certification data, and other qualifications, such as the Certified 
Medical Director designation and the Certificate of Added 
Qualifications in

[[Page 67777]]

Geriatric Medicine. One commenter supported inclusion of information 
about physician compliance with Medicare rules. Another commenter 
suggested including measures related to cancer care.
    Response: We appreciate the commenters' feedback and 
recommendations for including additional information on the Web site. 
We will review all recommendations provided and evaluate the 
feasibility for potential inclusion in the future. One important 
consideration around many of these recommendations is whether there is 
a readily available national-level data source. With this in mind, the 
recommendations will be closely evaluated.
    Comment: Several commenters noted the limitations of CAHPS for PQRS 
measures for some health care professionals and supported adding other 
types of patient experience data to Physician Compare, including the 
Surgical CAHPS[supreg] and experience data collected via other sources. 
One commenter suggested publicly reporting beneficiary satisfaction 
information in addition to CAHPS for PQRS measures. Another commenter 
suggested reporting patient experience data for primary care physicians 
and clinical quality performance for specialists.
    Response: We appreciate the commenters' feedback. We agree that 
Surgical CAHPS[supreg] data is useful to consumers and we are exploring 
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 cross-time comparisons.
    Response: We appreciate the commenters' feedback and the 
recommendation to consider longitudinal as well as other comparisons. 
We will evaluate these recommendations as we move forward with 
Physician Compare.
    Comment: One commenter suggested that the measures being removed 
from PQRS due to 100 percent performance be added to the Physician 
Compare Web site as display measures believing that these topped out 
measures would 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 create mechanisms to attribute 
Medicare Advantage quality data to physician groups for display on 
Physician Compare and enable CG-CAHPS vendors to include beneficiaries 
enrolled in MA, as well as in traditional Medicare fee-for-service.
    Response: We appreciate the commenters' suggestions and will 
evaluate the feasibility of these recommendations for the future.
5. Report to Congress
    Section 10331(f) of the Affordable Care Act, requires that no later 
than January 1, 2015, we submit a report to Congress on the Physician 
Compare Web site that includes information on the efforts of and plans 
made by the Secretary of Health and Human Services to collect and 
publish data on physician quality and efficiency and on patient 
experience of care in support of consumer choice and value-based 
purchasing. We anticipate timely submission of this report, including 
discussion about the phase-in of the Web site and developments to date. 
The report will also address the expansion of data on the Web site, in 
regard to section 10331(g) of the Affordable Care Act, and future plans 
for the Web site.

K. Physician Payment, Efficiency, and Quality Improvements--Physician 
Quality Reporting System

    This section contains the requirements for the Physician 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 specified 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 practice'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 2017 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 period, 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 focus on aligning our requirements with other 
quality reporting programs, such as the Medicare EHR Incentive 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 Sec.  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, including related laws and established 
requirements, are available at http://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/PQRS/index.html. In 
addition, the 2012 PQRS and eRx Experience Report, which provides 
information about eligible professional participation in PQRS, is 
available for download at http://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/PQRS/Downloads/2012-PQRS-and-eRx-Experience-Report.zip.
    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 mechanism 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 participation 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 
Quality's (AHRQ's) Clinician & Group (CG) Consumer Assessment of 
Healthcare Providers and Systems (CAHPS) survey measures, referenced at 
https://cahps.ahrq.gov/Surveys-Guidance/CG/

[[Page 67778]]

index.html. AHRQ's CAHPS Clinician & Group Survey Version 2.0 (CG-
CAHPS) includes 34 core CG-CAHPS survey 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 
survey 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 Sec.  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 therefore finalizing this proposal as proposed.
1. Requirements for the PQRS Reporting Mechanisms
    The PQRS includes the following reporting mechanisms: claims; 
qualified registry; EHR (including direct EHR products and EHR data 
submission vendor products); the Group Practice Reporting Option (GPRO) 
web interface; certified survey vendors, for the CAHPS for PQRS survey 
measures; and the QCDR. Under the existing PQRS regulation, Sec.  
414.90(h) through (k) govern which reporting mechanisms are available 
for use by individuals and group practices for the PQRS incentive and 
payment adjustment. This section III.K.1 contains our proposals to 
change the qualified registry, direct EHR and EHR data submission 
vendor products, 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 qualified registry, EHR, QCDR, 
and GPRO web interface reporting mechanisms (79 FR 40392, 40393, and 
40395 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 
more frequent submissions of data preferred that the ability to provide 
more frequent submission of data be optional, not mandatory. We 
appreciate the commenters' support for this concept and will consider 
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 
registries for the purpose of verifying that a qualified registry is 
prepared to submit data on PQRS quality 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 report on at least 9 measures covering 3 NQS domains--an 
eligible professional or group practice who sees at least 1 Medicare 
patient in a face-to-face encounter, as 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 the 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 being 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 transmit 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 which 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 all 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 be overly burdensome for certain registries, such as those 
registries geared towards specialties 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 cross-
cutting 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 payment 
adjustment, the registry must be able to report to report on at least 1 
cross-cutting measure on behalf of its participating eligible 
professionals and group practices.
    Furthermore, in the CY 2013 PFS final rule, we noted that qualified 
registries have until the last Friday of February following the 
applicable reporting period (for example, February 28, 2014, for 
reporting periods ending in 2013) to submit quality measures data on 
behalf of its eligible professionals (77 FR 69182). We continue to 
receive stakeholder feedback, particularly from qualified registries 
currently participating in the PQRS, urging us to extend this 
submission deadline due to the time it takes for these qualified 
registries to collect and analyze the quality measures data received 
after the end of the reporting period. Although, at the time, we 
emphasized the need to have quality measures data received by CMS no 
later than the last Friday of the February occurring after the end of 
the applicable reporting period, we believe it is now feasible to 
extend this deadline. Therefore, we proposed to

[[Page 67779]]

extend the deadline for qualified registries to submit quality measures 
data, including, but not limited to, calculations and results, to March 
31 following the end of the applicable reporting period (for example, 
March 31, 2016, for reporting periods ending in 2015). We invited 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, including, but not limited 
to, calculations and results, to March 31 following the end of the 
applicable reporting 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 period, 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-approved XML format utilizing a Clinical Document Architecture 
(CDA) standard such as Quality Reporting Data Architecture (QRDA) level 
1 (and for EHR data submission vendor products that intend to report 
for purposes of the proposed PQRS-Medicare EHR Incentive 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 69187). 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 comply with CMS Implementation Guides for both the QRDA-I 
and QRDA-III data file formats. The Implementation Guides for 2014 are 
available at http://www.cms.gov/Regulations-and-Guidance/Legislation/EHRIncentivePrograms/Downloads/Guide_QRDA_2014eCQM.pdf. Updated guides 
for 2015, when available, will be posted on the CMS EHR Incentive 
Program Web site at http://www.cms.gov/Regulations-and-Guidance/Legislation/EHRIncentivePrograms. These implementation guides further 
describe the technical requirements for data submission to ensure the 
data elements required for measure calculation and verification are 
provided. We proposed to continue applying these requirements to direct 
EHR products and EHR data submission vendor products for 2015 and 
beyond. We received no public comment on our proposal to continue 
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 QRDA-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 vendors. 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) and 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 this 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 participation in 
a QCDR that we proposed for the 2017 PQRS payment adjustment, we 
proposed to require 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, 
particularly 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 
criterion for satisfactory participation in a QCDR for the 2017 PQRS 
payment adjustment by only requiring that 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 experience of care, efficiency/
appropriate use, or safety). Since this proposal was intended to be 
consistent with 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 possess 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 other 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 2015 and still qualify to become or remain a QCDR 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 professional at this time (78 FR 74476). 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 option, particularly during its early stages, we believe that 
the benefits of allowing QCDRs potentially to cover a broader range of 
specialties and sub-

[[Page 67780]]

specialties outweigh the commenters' concerns. Therefore, we are 
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 that QCDRs are not required 
to report on 30 non-PQRS measures. Rather, the reporting of non-PQRS 
measures is optional, and our final rule here increases the number of 
optional additional measures 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 parameters for a measure to be 
considered a non-PQRS measure:
    <bullet> A measure that is not contained in the PQRS measure set 
for the applicable reporting period.
    <bullet> 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 sampling 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 QCDR instead of through 
the GPRO Web interface. Therefore, due to the substantive changes 
needed to report this measure via a QCDR, PQRS measure 319 would be 
considered a non-PQRS measure. In addition, 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 Web site at http://www.cms.gov/Medicare/Quality-
Initiatives-Patient-Assessment-Instruments/pqrs/index.html.
    Public Reporting of QCDR Quality Measures Data:
    Furthermore, under our authority to establish the requirements for 
an entity to be considered a QCDR under section 1848(m)(3)(E)(i) of the 
Act, we established 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 the 
following requirement that an entity must meet to serve as a QCDR under 
the PQRS for reporting periods beginning in 2015:
    <bullet> Require that the entity make available to the 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 that we 
believe will give patients adequate information on the care provided by 
an eligible professional: The title and description of the measures 
that a QCDR reports for purposes of the PQRS, as well as the 
performance results 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 manner 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 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.
    Response: With respect to the commenters who opposed this proposal 
and urged CMS not to make additional changes to the QCDR option while 
entities become more familiar with this option, we understand the 
commenters' concerns. However, we believe 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 not 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 believe that QCDRs were on notice that we would propose 
and finalize a requirement to make quality measures data available to 
the public beginning with the CY 2015 reporting.
    However, although we do not believe we should further delay 
requiring public report of QCDR quality measures data, we do agree with 
the commenters on delaying public posting of measures information until 
a measure has been tested for validity 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 
PQRS 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 QCDR, 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 available to the public the quality measures data for which 
its eligible professionals report. However, as we explained 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

[[Page 67781]]

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 eligible professionals, quality measures performance 
data for the measure (except for the data collected 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 the quality measures data it collects for the PQRS. For 
example, to meet this requirement, it would be sufficient for a QCDR to 
publicly report performance rates of eligible professionals through 
means such as board or specialty Web sites, 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 the same practice together (but who 
are not registered 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 level for certain eligible 
professionals when those who are in the same practice contribute to the 
overall care provided to a patient.
    <bullet> 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 periods 
occurring in 2015). The deadline of April 31 will provide QCDRs with 
one month to post quality measures data and information following the 
March 31 deadline for the QCDRs to transmit quality measures data for 
purposes of the PQRS payment adjustments. Please note that we 
erroneously stated the proposed deadline as April 31, which does not 
exist in the calendar. We intended to propose a deadline 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 responses 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 does 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 reasonably 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 changes in measure title and description, as well as 
when new performance results are calculated. We solicited 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 should be tested for accuracy and 
reliability. One commenter stated that QCDRs need more time following 
the QCDR submission deadline of March 31 to publicly post quality 
measures data. Another 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 their initial year of reporting under the PQRS) is reasonable, as we 
assume QCDRs would have already 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 deadline. However, we agree with the 
commenter on the need to provide accurate and reliable 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 the deadline by which Physician Compare posts QCDR 
quality measures data as discussed in section III.J above. That is, as 
indicated in Table 49 in section III.J.3 above, QCDRs wishing to 
publicly report quality 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 entities wishing to 
become QCDRs for reporting periods occurring in 2014, we received 
feedback from many organizations who 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 beginning in 
2015 on situations where an entity may not meet the requirements of a 
QCDR solely on its own but, in conjunction with another entity, may be 
able to meet the requirements of a QCDR and therefore be eligible for 
qualification:
    <bullet> We proposed to allow that an entity that uses 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 the 
relationship and responsibilities of the entity with the external 
organizations effective as of January 1 the 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 by 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 proposal, as it allowed 
entities such as medical boards that may not have the technical 
capabilities to submit quality measures data calculations and results 
to CMS to collaborate with other entities.
    Response: We appreciate the commenters' support. Based on the 
comments received, for the reasons stated here, and in the proposed 
rule, we are finalizing this proposal.
    <bullet> 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 QCDR qualification as of the earliest date the larger 
organization begins continual existence. We received questions from 
entities who used to be part of a larger organization but have recently 
become independent from the larger organization as to whether the 
entities would meet the requirement established in the CY 2014 PFS 
final rule with comment period that the entity be in

[[Page 67782]]

existence as of January 1 the year prior 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 medical society and become an 
independent registry in 2014. Likewise, a member of a medical society 
could create a registry separate from 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 
considered for qualification for reporting periods occurring in 2014. 
In these examples, for purposes of meeting the requirement 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' support and, based on the 
comments received and for the reasons stated above, we are finalizing 
this proposal.
    Data Submission Deadline:
    In the CY 2014 PFS final rule with comment period, 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 period to submit 
quality measures data to CMS (78 FR 74471). In accordance with our 
proposal to extend this deadline for qualified registries, we proposed 
to extend the deadline for QCDRs to submit quality measures data 
calculations and results by March 31 following the end of the 
applicable reporting period (that is, March 31, 2016, for reporting 
periods ending in 2015).
    We solicited 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 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 period (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 period (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 respond 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 periods occurring 
in 2015). Specifically, although we still seek to provide group 
practices with as much time as feasible to decide whether to register 
to participate 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 other 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 the GPRO, we believe the benefit of providing 
timelier feedback reports outweighs this concern. We solicited and 
received the following 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 periods occurring in 2015) in order to 
provide timelier feedback reports. Other commenters opposed our 
proposal to shorten the deadline from September 30 to June 30, as the 
commenters believed that the extra 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 particularly important when reporting via 
EHR, as updates are required for EHR products. Some commenters 
requested 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 difficult 
for group practices to transition to an earlier registration date and 
requested that CMS delay finalizing this proposal to 2016. Other 
commenters stated that the proposed deadline would negatively affect 
group practices that change their Taxpayer Identification Number (TIN) 
after June 30, as the group practice would be required to report 
individually, adding to administrative and reporting burden.
    Response: With respect to the comments opposing 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, as 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 Web site 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 <a href="/cdn-cgi/l/email-protection#9bcaf5feefe8eeebebf4e9efdbf3f8eaf2e8b5f4e9fc"><span class="__cf_email__" data-cfemail="13427d7667606663637c6167537b70627a603d7c6174">[email protected]</span></a>. With respect to some 
commenters' requests that information 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-Patient-Assessment-Instruments/PQRS/Downloads/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 would negatively affect group 
practices that change their

[[Page 67783]]

Taxpayer Identification Numbers (TINs) after June 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 months 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 30th registration deadline 
or ameliorated by keeping the current September 30 registration 
deadline. To the extent that finalizing an earlier deadline would 
increase 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 being 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 
GPRO 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 practices 
wishing to participate in the GPRO using any reporting mechanism 
available for reporting in the GPRO (that is, GPRO web interface, 
registry, EHR, and/or CMS-certified survey vendor).
2. Criteria for the Satisfactory Reporting for Individual 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 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 services 
furnished by such professional during the year (including the fee 
schedule amount for purposes of determining a payment based on such 
amount) shall be equal to the applicable percent of the fee schedule 
amount that would otherwise apply to such services. For 2016 and 
subsequent years, the applicable percent is 98.0 percent.
a. Criterion for the Satisfactory Reporting of Individual Quality 
Measures via Claims and Registry for Individual Eligible Professionals 
for the 2017 PQRS Payment Adjustment
    In the CY 2014 PFS final rule with comment period (see Table 47 at 
78 FR 74479), we finalized the following criteria for satisfactory 
reporting for 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 eligible professional would be subject 
to the measure application validity (MAV) process, which would allow us 
to determine whether the eligible professional should have reported 
quality data codes for additional measures.
    To be consistent with the satisfactory reporting criterion we 
finalized for the 2014 PQRS incentive, for the 2017 PQRS payment 
adjustment, we proposed to modify Sec.  414.90(j) and proposed the 
following criterion for individual eligible professionals reporting via 
claims and registry: For the 12-month reporting period for the 2017 
PQRS payment adjustment, the eligible professional would 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 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 applies. 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 PQRS payment adjustment 
reporting period to report at least 2 measures contained in the cross-
cutting measure set specified in Table 52. As we noted in the CY 2014 
PFS proposed rule (78 FR 43359), we are dedicated 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 quality 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 at http://www.qualityforum.org/Publications/2014/01/MAP_Pre-Rulemaking_Report-2014_Recommendations_on_Measures_for_More_than_20_Federal_Programs.aspx)
, the Measure Applications Partnership (MAP) encouraged the development 
of a core measure set (see page 16 of the ``MAP Pre-Rulemaking Report: 
2014 Recommendations on Measures for More than 20 Federal Programs''). 
The MAP stated, ``a core [measure 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 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 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 and 40396).
    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 incentive (see Table 47 at 78

[[Page 67784]]

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, which would allow us 
to determine whether an eligible professional should have reported 
quality data codes for additional measures. In addition, the MAV will 
also allow us to determine whether a group practice should have 
reported on any of the cross-cutting measures specified in Table 52. 
The MAV process 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 the 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 claims-based 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 option 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 commenters believe the 
claim-based reporting mechanism is a necessary option for eligible 
professionals with limited resources, such as solo practitioners. 
Should we intend to phase out this reporting mechanism, commenters 
urged a gradual phase out of the claims-based reporting mechanism.
    Response: We appreciate the commenters' feedback. We understand the 
concerns associated with moving away from the claims-based reporting 
mechanism. For the 2017 PQRS payment adjustment, we are finalizing an 
option by which eligible professionals 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 reporting 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 
intention to eliminate the claims-based reporting mechanism in future 
rulemaking. 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 
reporting for the 2017 PQRS payment adjustment. Some of these 
commenters noted that eligible professionals have been successful at 
meeting the criteria 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 eligible professionals to meet the criteria for 
satisfactory reporting for the 2017 PQRS payment adjustment. Other 
commenters also noted that certain eligible professionals do not have 9 
measures covering 3 NQS domains to report. For these reasons, 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 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: While we understand the commenters concerns 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 payment adjustment via claims and registry that only required 
the reporting of 3 measures covering 1 NQS domain (see Table 48 at 78 
FR 74480). However, we also finalized criteria for the 2016 PQRS 
payment adjustment using the claims- and registry-based reporting 
mechanisms that aligned with the following 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 eligible 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 stringent than the 
criteria for satisfactory reporting for the 2014 PQRS incentive'' (78 
FR 74465). We believe 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 reporting criteria, provided enough advance notice to 
encourage eligible professionals to prepare to report 9 measures to 
meet the criteria for satisfactory reporting for the 2017 PQRS payment 
adjustment.
    Furthermore, with respect to those commenters concerned that an 
eligible professional may not have 9 measures covering at least 3 NQS 
domains applicable to his/her practice, in the proposed rule we noted 
that in this instance, like the criterion we finalized for the 2014 
PQRS incentive (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, which would allow us to determine whether an eligible 
professional should have reported quality data codes for additional 
measures. In addition, the MAV process will also allow us to determine 
whether a group practice should have reported on any of the cross-
cutting measures specified in Table 52. As such, under this proposed 
criteria for satisfactory reporting for the 2017 PQRS payment 
adjustment, 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

[[Page 67785]]

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 the 
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 data codes for additional measures.
    Comment: Some commenters provided general support 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 believed that the reporting of cross-
cutting measures should be voluntary, not mandatory. The majority of 
commenters 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 at 
least 2 measures contained in the proposed cross-cutting 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 those that do not provide primary care 
services, and not on others. Other commenters emphasized that the 
cross-cutting measures did not apply 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 approach 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: With respect to the commenters' concerns that requiring 
reporting of at least 2 cross-cutting measures for eligible 
professionals who see at least 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 professionals for which the measures apply. We believe we 
sufficiently exclude eligible professionals for which the cross-cutting 
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 participate in the reporting of a core set of 
measures. With respect to the commenters who expressed concern that the 
proposed measures in the proposed cross-cutting 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 the cross-
cutting measures set if none of the measures applied to the eligible 
professional's practice. With respect to taking a more phased-in 
approach to introducing the cross-cutting measure set, for the 2017 
PQRS payment adjustment, we agree with these commenters and will 
therefore phase-in the requirement 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 professionals 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 phase 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 payment 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 may 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 sufficiently exclude 
eligible professionals for which the cross-cutting 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 threshold of seeing 1 
Medicare patient in a face-to-face encounter for the requirement to 
report on cross-cutting measures is too low. The commenter was 
concerned that this would further burden eligible 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 patients. However, we expect those eligible professionals 
who see Medicare patients to report on the cross-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 urged 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

[[Page 67786]]

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 for purposes of the requirements 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 Web site at http://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/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 during the 
reporting period to which the 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 Medicare Part B FFS patients is 
burdensome.
    Response: We understand this concern, 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 
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 eligible professionals are still becoming 
accustomed to PQRS reporting. Based on the 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 
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 during the reporting 
period to which the measure applies.
    Comment: Some commenters generally supported 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 incentive 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 trigger use of the MAV process), available for the 2014 
MAV process at http://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/PQRS/AnalysisAndPayment.html, and we will update 
these materials as necessary for the 2015 MAV process. Please note 
that, as the MAV process evolves, we expect to be able to provide 
further guidance to aid eligible professionals in understanding the MAV 
process. We will post additional clarifying information, including a 
document explaining the MAV process for 2015, on the PQRS Web site at 
http://www.cms.gov/Medicare/Quality-Initiatives-Patient-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 have 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-Assessment-Instruments/PQRS/HelpDeskSupport.html.
    After reviewing the comments, we are finalizing our proposal to 
modify Sec.  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 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, the eligible professional 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. Measures with a 0 percent 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 practice. 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 would allow us to determine whether an eligible 
professional should have reported quality data codes for additional 
measures. In addition, the MAV process will also allow us to determine 
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 was 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-Assessment-Instruments/PQRS/Downloads/2014_PQRS_Claims_MeasureApplicabilityValidation_12132013.zip. For more 
information on the registry MAV process, please visit http://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/PQRS/Downloads/2014_PQRS_Registry_MeasureApplicabilityValidation_12132013.zip.
b. Criterion for Satisfactory Reporting of Individual Quality Measures 
via EHR for Individual Eligible Professionals for the 2017 PQRS Payment 
Adjustment
    In the CY 2013 PFS final rule with comment period, we finalized the

[[Page 67787]]

following criterion for the satisfactory reporting for individual 
eligible professionals 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 measures covering at least 3 
domains, then the eligible professional must report all of the 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 
(see Table 47 at 78 FR 74479).
    To be consistent with the criterion we finalized for the 2014 PQRS 
incentive, as well as to continue to align with the final criterion for 
meeting the clinical quality measure (CQM) component of achieving 
meaningful use under the Medicare EHR Incentive Program, we proposed to 
modify Sec.  414.90(j) and proposed the following criterion for the 
satisfactory reporting for individual eligible professionals 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: 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 measure 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 professionals 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 
reporting for the 2017 PQRS payment adjustment. Commenters also noted 
that certain eligible professionals do not have 9 measures covering 3 
NQS domains to report. For these reasons, 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 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' concerns. We note that we 
addressed these comments related to the reporting of 9 measures 
covering 3 domains as it relates to reporting via claims and registry 
above in section III.K.1.a., and that explanation also applies here 
with reporting via a direct EHR product that is CEHRT or EHR data 
submission vendor product that is CEHRT. Furthermore, we believe that 
aligning our EHR reporting options with the CQM component of meaningful 
use under the EHR Incentive Program actually reduces burden on eligible 
professionals when reporting. For the reasons explained above and to be 
consistent 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 Sec.  414.90(j) and to indicate the following 
criterion for the satisfactory reporting for individual eligible 
professionals 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: 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 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.
c. Criterion for Satisfactory Reporting of Measures Groups via Registry 
for Individual Eligible Professionals for the 2017 PQRS Payment 
Adjustment
    In the CY 2013 PFS final rule with comment period, we finalized the 
following criterion for the satisfactory reporting for individual 
eligible professionals to report measures groups via registry for the 
2014 PQRS incentive: For the 12-month reporting period 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 finalized for the 2014 PQRS 
incentive, we proposed to modify Sec.  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, 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 criterion 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 proposal as proposed to 
modify Sec.  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 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.
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 new standard for individual 
eligible professionals to satisfy the PQRS beginning in 2014, based on 
satisfactory participation in a QCDR.

[[Page 67788]]

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 for 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 services furnished by such professional during the 
year shall be equal 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.
    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 
professional 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 participating in a QCDR for the year. 
``Satisfactory participation'' is a new standard under the PQRS and is 
a substitute for the underlying standard of ``satisfactory reporting'' 
data on covered professional services that eligible professionals must 
meet to avoid the PQRS payment adjustment. Currently, Sec.  
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 
adjustment that are less stringent than the satisfactory participation 
criteria we finalized for the 2014 PQRS incentive, we noted that it was 
``our intention to fully move towards the reporting of 9 measures 
covering at least 3 domains to meet the criteria for satisfactory 
participation for the 2017 PQRS payment adjustment'' (78 FR 74477). 
Specifically, we finalized the following two criteria for the 
satisfactory participation in a QCDR for the 2014 PQRS incentive at 
Sec.  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 at least 50 
percent of the eligible professional's applicable patients. Of the 
measures reported via a QCDR, the eligible professional must report 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 purposes of the 2017 PQRS payment adjustment (which 
would be based on data reported during the 12-month period that falls 
in CY 2015), we proposed to modify Sec.  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 professional 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 types 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 Sec.  
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 towards 
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 eligible professional 
provides than, for example, process measures (for example, whether a 
Hemoglobin A1c test was performed for diabetic patients). In 
establishing this proposal, we understood that a QCDR may not have 3 
outcomes measures within its quality measure data set. Therefore, as an 
alternative 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.
    Comment: Commenters generally urged more flexibility in allowing 
QCDRs to determine reporting criteria under this option.
    Response: While we agree that QCDRs should 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 consistent 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 
reporting for the 2017 PQRS payment adjustment. Commenters also noted 
that certain eligible professionals do not have 9 measures covering 3 
NQS domains to report. For these reasons, 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 measures.
    Response: While we understand the commenters' concerns 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 payment 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 
covering 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 PQRS 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 signaling our intent to ramp up the 
satisfactory reporting criteria provided enough advance notice to 
encourage eligible professionals to prepare to report 9 measures to 
meet the criteria for

[[Page 67789]]

satisfactory reporting for the 2017 PQRS payment adjustment. Based on 
the comments received and for the reasons stated, we are 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 the 
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 concern, particularly with respect to 
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 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 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 eligible professionals are 
still becoming accustomed to PQRS reporting. Based on the 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 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 the measure 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 
QCDRs might not have 3 outcome measures available to report. The 
commenters urged a more gradual approach to the reporting of outcome 
measures via a QCDR.
    Response: We understand the commenters' concerns. 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 measures 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 category 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 addition of another 
category of measures that may be reported in lieu of an outcome measure 
benefits eligible 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 
professional may report in lieu of an outcome measure. We define the 
term ``patient safety'' as it applies to QCDRs in the QCDR measure 
section in III.K.6 below.
    As a result of the comments, we are revising our proposal to modify 
Sec.  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 following types of measures--resource 
use, patient experience of care, efficiency/appropriate use, or patient 
safety.
4. Criteria for Satisfactory Reporting for Group Practices 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 measures. 
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 participating 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-Assessment-Instruments/PQRS/Group_Practice_Reporting_Option.html. For more 
information on registration, please visit http://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/PhysicianFeedbackProgram/Self-Nomination-Registration.html.
a. Criteria for Satisfactory Reporting on PQRS Quality 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 Sec.  414.90(j) 
to incorporate the following criterion for the satisfactory reporting 
of PQRS quality measures for group practices 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 25-99 
eligible professionals: The group practice would 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 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 
25-99

[[Page 67790]]

eligible professionals. If the group practice is assigned less than 248 
Medicare beneficiaries, then the group practice would 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 Sec.  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 survey vendor. In addition, the 
group practice would 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 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 proposed 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 and reliable performance results. 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 analysis, we believe that 
there are increased performance reliabilities and validities gained 
when changing the minimum reporting 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 Physician Compare public reporting, discussed in 
section III.N and section III.J respectively. Therefore, we believe 
this criterion improves on the criterion previously finalized.
    For assignment of patients for group practices reporting via the 
GPRO web interface, in previous years, we have aligned with the 
Medicare Shared Savings Program methodology of beneficiary assignment 
(see 77 FR 69195). We note that, in section III.N. of the CY 2015 PFS 
proposed rule, we proposed to use a beneficiary attribution methodology 
for the VM for the claims-based quality measures and cost measures that 
is slightly different from 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 
method of attribution is appropriate, as the VM is directly tied to 
participation in the PQRS. Therefore, 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 interface 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 
interface to report on a patient sample of 248. With respect to having 
group practices of 100 or more eligible professionals report on a 
patient sample of 248 in lieu of 411 (the required patient sample for 
group practices of 100 or more eligible professionals for the 2014 PQRS 
incentive), the commenters agreed that this would reduce the reporting 
burden while still ensuring statistically valid and reliable 
performance results.
    Response: We appreciate the commenters' feedback. 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 
interface, a group practice would be required to report on at least 248 
patients.
    As a result of the comments, we are finalizing the following 
criteria for satisfactory reporting for the 2017 PQRS payment 
adjustment for group practices comprised of 25 to 99 eligible 
professionals using the 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.
    In addition, we note that, in the past, we have not provided 
guidance on those group practices that choose the GPRO web interface to 
report PQRS quality measures but have seen no Medicare patients for 
which the GPRO measures are applicable, or if they have 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 
practice must be assigned and have sampled at least 1 Medicare patient 
for any of the applicable GPRO web 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 participate 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 for group practices comprised of 25-99 eligible

[[Page 67791]]

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 discuss in greater detail in section III.K.4 below, 
since 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 
Registry 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 practices 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 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 reporting period to which the measure 
applies. Measures with a 0 percent performance rate would not be 
counted. In the CY 2014 PFS final rule with comment period, 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 the Act, for those group practices that choose to 
report using a qualified registry, we modified Sec.  414.90(j) to 
include the following satisfactory reporting criterion via qualified 
registry for ALL group practices who 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 practice 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 covering 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 during the reporting 
period to which the measure applies. Measures with a 0 percent 
performance rate would not be counted.
    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 group 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 measures, 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 Medicare patient in a face-to-
face encounter. The MAV process we proposed to implement for registry 
reporting 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-Assessment-Instruments/PQRS/Downloads/2014_PQRS_Registry_MeasureApplicabilityValidation_12132013.zip.
    For EHR reporting, consistent with the criterion finalized for the 
2014 PQRS incentive that aligns with the criteria established for 
meeting the CQM component 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 
Sec.  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 practice 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 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. We invited public 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 
reporting 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 criteria 
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 group practices to meet the criteria for satisfactory reporting 
for the 2017 PQRS payment adjustment. Other 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 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 group practices practicing in specialties 
for which few PQRS measures exist.
    Response: While we understand the commenters concerns 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 payment adjustment via registry that only required the 
reporting of 3 measures covering 1 NQS domain (see Table 50 at 78 FR 
74486). However,

[[Page 67792]]

we also finalized criteria for the 2016 PQRS payment adjustment using 
the registry- and EHR-based reporting mechanisms that aligned with the 
criteria we finalized for the 2014 PQRS incentive that generally 
required reporting of at least 9 measures covering at least 3 NQS 
domains. 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 PQRS 
incentive'' (78 FR 74465). We believe that establishing criteria for 
the satisfactory reporting of the 2016 PQRS payment adjustment that are 
consistent with this proposed criteria, as well as signaling our intent 
to ramp up the satisfactory reporting criteria, provided enough 
advanced notice to encourage eligible professionals to prepare to 
report 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 with 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 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'' (79 FR 40399). Under this proposed criterion for 
satisfactory reporting for the 2017 PQRS payment adjustment for group 
practices reporting via registry, a group practice who does not have at 
least 9 measures covering at least 3 NQS domains 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 satisfactory 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 reporting in section III.K.2.a. Some commenters provided 
general support for the option to report cross-cutting measures via 
registry, as it may help bring alignment with respect to a set of 
measures all group practices may report. However, most of these 
commenters believed that the reporting of cross-cutting 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 the 
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 apply 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 approach 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 these 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 measure contained in the cross-
cutting measure set we are finalizing specified in Table 52.
    Please note that this does not bring the total number 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 adjustment reporting period, 
1 of the 9 measures the group practice reports must be measures 
contained in the cross-cutting measure set. Therefore, a group practice 
would report at least 1 cross-cutting 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 required to report at least 1 cross-cutting measure, if 
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 threshold of seeing 1 
Medicare patient in a face-to-face encounter for the requirement to 
report on cross-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 patients. However, we expect those group practices that 
see Medicare patients to report on the cross-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 urged 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 for 
purposes of the proposals requiring reporting of at least 2 cross-
cutting measures specified in Table 52. While we will not provide the 
specific

[[Page 67793]]

codes for what we definite as a ``face-to-face'' encounter here, we 
will provide additional guidance on the PQRS Web site at http://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/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 
the measure applies. The commenters noted that, 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 
Medicare Part B FFS patients is an enormous burden.
    Response: We understand this concern, particularly with those group 
practices that see a large number of patients. However, it is important 
to collect sufficient quality measures 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 potential 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 reasons 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 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 
the measure applies.
    Comment: Some commenters generally supported 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 understanding the MAV process. We will post additional 
clarifying information, including a ``made simple'' document on the MAV 
process for 2015 on the PQRS Web site at http://www.cms.gov/Medicare/
Quality-Initiatives-Patient-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 a group 
practice have further questions regarding the MAV process, he/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-Assessment-Instruments/PQRS/HelpDeskSupport.html.
    Because of the comments, we are finalizing our proposal to modify 
Sec.  414.90(j) and finalize the following criteria for satisfactory 
reporting for group practices participating in the GPRO via registry 
and EHR for the 2017 PQRS payment adjustment:
    For group practices comprised of 2-99 eligible professionals 
reporting for 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 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.
    We understand that there may be instances where a group practice 
may not have at least 9 measures applicable to an eligible 
professional's practice. 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 applicable, 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 reported quality data codes for additional 
measures. In addition, the MAV will also allow us to determine 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 was 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-Assessment-Instruments/PQRS/Downloads/2014_PQRS_Claims_MeasureApplicabilityValidation_12132013.zip. For more 
information on the registry MAV process, please visit http://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/PQRS/Downloads/2014_PQRS_Registry_MeasureApplicabilityValidation_12132013.zip.
    For group practices comprised of 2-99 eligible professionals 
reporting for 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 measures for which there is patient data. A group practice 
must report on at least 1 measure for 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 
practices comprised of 2-99 eligible professionals. The final criteria 
for group practices comprised of 100 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 CMS-Certified Survey Vendor for the 2017 PQRS Payment Adjustment
    In the CY 2014 PFS final rule with comment period, we introduced 
satisfactory reporting criterion for the 2014 PQRS incentive related to 
reporting the CG CAHPS survey measures via a CMS-certified survey 
vendor (see Table 49 at 78 FR 74486). Consistent with the criterion 
finalized for the 2014 PQRS incentive and the group practice reporting 
requirements under section 1848(m)(3)(C) of the Act, we proposed 3 
options (of which a group practice would 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

[[Page 67794]]

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 payment adjustment, a group practice 
participating in the PQRS GPRO would be required to use 1 of these 3 
proposed reporting options mentioned above (that 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 
practices of 100 or more eligible professionals to report the CAHPS for 
PQRS survey measures. Therefore, the group 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 
eligible professionals. We noted 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 related 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 professionals 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 survey on their behalf. These commenters believe that 
this requirement was too burdensome, particularly because CMS is not 
bearing the cost of administering the survey. Some of these commenters 
requested that CMS delay requiring the reporting of CAHPS for PQRS to 
the 2016 reporting period. Other commenters requested 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 years 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 interface, qualified registry or 
EHR and groups of 100 or more eligible professionals reporting via 
qualified registry or EHR had the option to report CAHPS for PQRS in 
2014. We believe that 2 years 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 the PQRS GPRO to report CAHPS for PQRS places on these 
group practices, we understand that this proposed requirement could 
bring additional reporting burden on these larger group practices. We 
believe that the value of the information contained in the CAHPS for 
PQRS survey outweighs this concern. 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 proposed rule, we are finalizing our proposal 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.
    We are also finalizing our proposal to make the 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' concerns regarding 
having the group practices bear the cost of administering the CAHPS for 
PQRS survey, particularly for those group practices who will be 
required to report CAHPS for PQRS to meet the criteria 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 the cost of the CAHPS for PQRS 
survey for 2013 and 2014 provided adequate time for group practices to 
become 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 comprised of 2-99 eligible professionals. 
However, group practices comprised of 100 or more eligible 
professionals 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 adjustment, 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

[[Page 67795]]

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.
    Consistent with the group practice reporting option solely using a 
qualified registry for the 2017 PQRS payment adjustment, we understand 
that there may be instances where a group practice may not have at 
least 6 measures applicable to a group practice's practice. In this 
instance, a group practice reporting on less than 6 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, 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 CAHPS for PQRS, 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. For more information on the 
registry MAV process, please visit http://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/PQRS/Downloads/2014_PQRS_Registry_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 submission vendor that is CEHRT 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, 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 less than 6 measures apply to the 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.
    Option 3--GPRO Web Interface: Alternatively, 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 percent of assigned beneficiaries. A 
group practice will be required to report on at least 1 measure for 
which there is Medicare patient data.
    Tables 50 and 51 provide a summary of the final criteria 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 you 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 comments last year 
supporting the inclusion of the Consumer Assessment of Healthcare 
Providers Surgical 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 the patient is 
the best source of information. The survey asks patients to provide 
feedback on surgical care, 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 tested 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 and 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 collect 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 comments on how to allow for reporting of the S-
CAHPS survey measures for the 2018 PQRS payment adjustment 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:
    Comment: The majority of commenters supported the introduction of 
S-CAHPS in the PQRS. These commenters supported our proposal to allow 
the 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 currently being 
reported under the PQRS. Other commenters expressed concerns on 
introducing S-CAHPS for the PQRS. One commenter stated that S-CAHPS 
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 S-CAHPS 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 data, 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 the 
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 introduce S-CAHPS 
in the PQRS measure set for future years.

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5. Statutory Requirements and Other Considerations for the Selection of 
PQRS Quality Measures for Meeting the Criteria for Satisfactory 
Reporting for 2015 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 for 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 professionals and group practices under the PQRS. Under 
section 1848(k)(2)(C)(i) of the Act, the PQRS quality measures shall be 
such measures selected by the Secretary from measures that have been 
endorsed by the entity with a contract with the Secretary under section 
1890(a) of the Act, which is currently the National Quality Forum 
(NQF). However, in the case of a specified area or medical topic 
determined appropriate by the Secretary for which a feasible and 
practical measure has not been endorsed by the NQF, section 
1848(k)(2)(C)(ii) of the Act authorizes the 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 these statutory requirements, we 
believe that, except in the circumstances specified in the statute, 
each PQRS quality measure must be endorsed by the NQF. Additionally, 
section 1848(k)(2)(D) of the Act requires that for each PQRS quality 
measure, ``the Secretary shall ensure that eligible professionals have 
the opportunity to provide input during the development, endorsement, 
or selection of measures applicable to services they furnish.'' The 
statutory requirements under section 1848(k)(2)(C) of the Act, subject 
to the exception noted previously, require only that the measures be 
selected from measures that have been endorsed by the entity with a 
contract with the Secretary under section 1890(a) of the Act (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 other 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 development of physician measures, such as restricting the 
initial development to physician-controlled organizations. Any such 
restriction would unduly limit the basic development of quality 
measures and the scope and utility of measures that may be considered 
for endorsement as voluntary consensus standards 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 contract with the Secretary under section 1890(a) of the 
Act (that is, the NQF) convene multi-stakeholder 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 reporting 
under the PQRS. In accordance with section 1890A(a)(1) of the Act, the 
NQF convened multi-stakeholder groups by creating the

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Measure Applications Partnership (MAP). Section 1890A(a)(2) of the Act 
requires that the Secretary must make publicly available by December 
1st of each year a list 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 selection 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 apply the following considerations when submitting 
measures for possible inclusion in the PQRS measure set:
    <bullet> Measures that are not duplicative of another existing or 
proposed measure.
    <bullet> Measures that are further along in development than a 
measure concept.
    <bullet> CMS is not accepting claims-based-only reporting measures 
in this process.
    <bullet> Measures that are outcome-based are preferred to clinical 
process measures.
    <bullet> Measures that address patient safety and adverse events.
    <bullet> Measures that identify appropriate use of diagnosis and 
therapeutics.
    <bullet> Measures that identify care coordination and 
communication.
    <bullet> Measures that identify care coordination of patient 
experience and patient-reported outcomes.
    <bullet> Measures that address efficiency, cost and resource use.

As a general matter, please note that the measure tables contained in 
this section III.K. may also contain discussions of comments we 
received related to proposed changes to the measures included in the 
quality performance standard under the Shared Savings Program.

a. PQRS Quality Measures

    Taking into consideration the statutory and non-statutory 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 domains 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 process 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 and Outcomes. These 
are measures that reflect the potential to improve patient-centered 
care and the quality of care delivered to patients. They emphasize the 
importance of collecting patient-reported data and the ability to 
impact care at the individual patient level, as well as the population 
level. 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 partnerships 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 
understanding 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 families to improve appropriate 
and timely patient and care team communication. They may also be 
measures that reflect outcomes of successful coordination of care.
    (4) Effective clinical care. These are measures that reflect 
clinical care processes closely linked to outcomes based on evidence 
and practice guidelines 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 of 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 specifications for any 
given PQRS individual quality measure may differ from specifications 
for the same quality 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 measure 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 
Program for Eligible Professionals updates its measure titles to 
include version numbers (77 FR 13744), we will use these version 
numbers to describe the PQRS EHR measures that will also be available 
for reporting for the EHR Incentive Program for Eligible Professionals. 
We will continue to work toward complete alignment of measure 
specifications across programs, whenever possible.
    Through NQF's measure maintenance process, NQF-endorsed measures 
are sometimes updated to incorporate changes that we believe do not 
substantively change the nature of the measure. Examples of such 
changes could be updated diagnosis or procedure codes or changes to 
exclusions to the patient population or definitions. We believe these 
types of maintenance changes are distinct from substantive changes to 
measures that result in what 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.
    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 adopted 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 incorporate non-substantive NQF

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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 measure 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 
links to where additional information on the updates can be found. 
Updates will also be available on the CMS PQRS Web site at http://www.cms.gov/Medicare/Quality-Initiatives-Patient-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 
developers 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 maintain 
the measure. We noted that this proposal is contingent upon the measure 
owner/developer not being able to maintain the measure. Should we learn 
that a certain measure owner/developer is able to maintain 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 proposed 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 feedback from 
stakeholders, particularly first-time participants who find it 
difficult to understand which measures are applicable to their 
particular practice. In an effort to aid eligible professionals and 
group practices to determine what measures best fit their practice, and 
in collaboration with specialty societies, we are beginning to group 
our final measures available for reporting according to specialty. The 
current listing of our measures by specialty can be found on our Web 
site at http://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/PQRS/index.html. Please note that these groups 
of measures are meant to provide guidance to those eligible 
professionals seeking to determine what measures to report. Eligible 
professionals are not required to report measures according to these 
suggested groups of measures. In addition to group measures according 
to specialty, we also plan to have 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 period, 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 updated 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 Receptor/Progesterone Receptor (ER/PR) Positive Breast Cancer 
(NQF 0387), a substantive error was discovered 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 Receptor (ER/
PR) Positive Breast Cancer (NQF 0387)--currently version CMS140v3--for 
the year.
b. Cross-Cutting Measure Set for 2015 and Beyond
    In accordance with our criteria for the satisfactory 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 proposed 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 cross-cutting 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 available for certain cross-cutting measures in Table 52 
from the reporting options we proposed would be available in the CY 
2015 PFS proposed rule (79 FR 40404). To the extent that changes to the 
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 regarding our proposals 
related to the proposed cross-cutting measure set:
    Comment: Several commenters supported the development of a cross-
cutting measure set as well as the composition as proposed, while other 
commenters were concerned about this new requirement noting the 
measures may not be as applicable to some specialists.
    Response: With respect to the commenters 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 
requiring reporting of a cross-cutting measures in a face-to-face 
encounter would exclude those eligible professionals for which the 
measures do not apply. With respect to taking a more phased-in approach 
to introducing the cross-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 reporting of 1 measure in the 
cross-cutting measures set is not overly burdensome and may help 
eligible professionals by providing direction on what measures to 
report. We are modifying our proposal to only require eligible 
professionals who see at least 1 Medicare patient in a face-to-face 
encounter to report on 1 cross-cutting measure.

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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 measures as well as our final decisions 
on these proposed measures. We have also indicated the PQRS reporting 
mechanism or mechanisms through which each measure could be submitted. 
As stated above, please note that the following tables may also contain 
discussions of comments we received related to proposed changes to the 
measures included in the quality performance standard under the Shared 
Savings Program.

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    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 measure'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 for Measures process each program year. We value 
feedback from measure developers and are dedicated to making updates to 
the PQRS program a transparent and collaborative process as it works to 
establish measures that are applicable to various domain categories.

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    In Table 55, we provide the responses and final decisions related 
to the measures we proposed to remove from reporting under the PQRS (79 
FR 40426).

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    In Table 56, we provide our responses and final decisions related 
to our proposals to change the way in which previously established 
measures in the PQRS will be reported beginning in 2015 (79 FR 40441).

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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 measures 
within a particular measures group.
    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 from 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 
measures 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 Sec.  414.90(b) to define a 
measures group as a subset of six 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 proposal. Commenters noted 
that CMS did not work with the measure group developers and owners to 
create the proposed measures groups that consist of at least 6 measures 
and were concerned that the additional measures in the proposed 
measures groups were arbitrarily added and not

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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 measures within the measures 
groups that we believed were clinically relevant to report, as we 
believe these measures address topics and clinical conditions that are 
accepted in the 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 
Reconciliation. With respect to the concern that measures developers 
and measure owners were not consulted when developing our proposal to 
add measures to the measures groups, we will continue to work with the 
measure developers and owners to address any concerns they may have 
with the final 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 Sec.  414.90(b) to 
define a measures group as a subset of six or more PQRS measures that 
have a particular clinical condition or focus in common.
    In addition, we proposed to add two new measures groups that will 
be available for reporting in the PQRS beginning in 2015: The Sinusitis 
and Acute Otitis Externa (AOE) measures groups (79 FR 40457).
    Furthermore, we proposed to remove the following measures groups 
(79 FR 40457):
    <bullet> Perioperative care measures group;
    <bullet> Back pain measures group;
    <bullet> Cardiovascular prevention measures group;
    <bullet> Ischemic Vascular Disease (IVD) measures group;
    <bullet> Sleep Apnea measures group; and
    <bullet> Chronic obstructive pulmonary disease (COPD) measures 
group.
    We received the following comments on our proposals related to our 
proposals related to either the proposed addition or removal of the 
following measures groups:
    Comments on the proposed removal of the Perioperative Care Measures 
Group: Several commenters requested that CMS retain the Perioperative 
Care Measures Group and the related individual measures noting the 
following: ``There is a bias in measuring that improves performance; 
(2) there are few measures 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 this bias is not impactful. 
Additionally, we believe that there are a number of broadly applicable 
measures that these specialty surgeons can report. 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 the Back Pain Measures Group: 
Several commenters were concerned with the proposal to remove the Back 
Pain measures group, noting it would negatively impact physician 
anesthesiologists', pain medicine physicians' and physical therapists' 
ability to report. Other commenters supported the removal of some of 
the Back Pain measure group measures such as ``Back Pain: Initial 
Visit'' and ``Back Pain: Physical Exam.''
    Response: The measures in this measure group reflect clinical 
concepts that do not add clinical value to PQRS. Specifically, the 
measures in this group are entirely clinical process measures that do 
not meaningfully contribute to improved patient outcomes, and CMS 
believes that removal of this measure group will not negatively impact 
physician anesthesiologists', pain medicine physicians', and physical 
therapists' ability to report. For these reasons, we are finalizing our 
proposal to remove the Back Pain 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 these reasons, we 
are finalizing our proposal to remove the Cardiovascular Prevention 
Measure Group from reporting in 2015 PQRS.
    Comments on the proposed removal of the Ischemic 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 
received about the removal of this measure group. For these reasons, we 
are finalizing 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 addition of this measure 
group.
    Response: We did not receive any dissenting 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 certain 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 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 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 measures provide substantial value to 
the specific clinical focus of this measures group. Instead, commenters 
recommend the addition of cross-cutting measure Preventive Care and 
Screening: Body Mass Index (BMI) Screening and Follow (PQRS #128) and 
Pain Assessment and Follow-up (PQRS #131) to achieve the goal of six 
measures while retaining clinical relevance. CMS agrees with 
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 clinical purpose of this measure

[[Page 67883]]

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 measures 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 measures groups and are 
therefore finalizing the respective measures groups as proposed.

           Table 57--Asthma Measures Group for 2015 and Beyond
------------------------------------------------------------------------
                   Measure title and
    NQF/PQRS          description               Measure developer
------------------------------------------------------------------------
0047/053.......  Asthma: Pharmacologic  AMA-PCPI/NCQA
                  Therapy 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.
0041/110.......  Preventive Care and    AMA-PCPI
                  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.
0419/130.......  Documentation of       CMS/QIP
                  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
                  medications' name,
                  dosage, frequency
                  and route of
                  administration.
0028/226.......  Preventive Care and    AMA-PCPI
                  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.
N/A/402........  Tobacco Use and Help   NCQA/NCIQM
                  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.
0421/128.......  Preventive Care and    CMS/QIP
                  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 outisde of
                  normal parameters, a
                  follow-up plan is
                  documented during
                  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\.
------------------------------------------------------------------------


 Table 58--Acute Otitis Externa (AOE) Measures Group for 2015 and Beyond
------------------------------------------------------------------------
                   Measure title and
    NQF/PQRS          description               Measure developer
------------------------------------------------------------------------
0653/091.......  Acute Otitis Externa   AMA-PCPI
                  (AOE): Topical
                  Therapy: Percentage
                  of patients aged 2
                  years and older with
                  a diagnosis of AOE
                  who were prescribed
                  topical preparations.
0654/093.......  Acute Otitis Externa   AMA-PCPI
                  (AOE): Systemic
                  Antimicrobial
                  Therapy--Avoidance
                  of Inappropriate
                  Use: Percentage of
                  patients aged 2
                  years and older with
                  a diagnosis of AOE
                  who were not
                  prescribed systemic
                  antimicrobial
                  therapy.
0419/130.......  Documentation of       CMS/QIP
                  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
                  medications' name,
                  dosage, frequency
                  and route of
                  administration.
0420/131.......  Pain Assessment and    CMS/QIP
                  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.
0101/154.......  Falls: Risk            AMA-PCPI
                  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.
0101/155.......  Falls: Plan of Care:   AMA-PCPI
                  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.
0028/226.......  Preventive Care and    AMA-PCPI
                  Screening: Tobacco
                  Use: Screening and
                  Cessation
                  Intervention:
                  Percentage of
                  patients 18 years
                  and older who were
                  screened for tobacco
                  use one or more
                  times within 24
                  months AND who
                  received cessation
                  counseling
                  intervention if
                  identified as a
                  tobacco user.
N/A/317........  Preventive Care and    CMS/QIP
                  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 AND a
                  recommended follow-
                  up plan is
                  documented based on
                  the current blood
                  pressure (BP)
                  reading as indicated.
------------------------------------------------------------------------


[[Page 67884]]


         Table 59--Cataracts Measures Group for 2015 and Beyond
------------------------------------------------------------------------
                   Measure title and
    NQF/PQRS          description               Measure developer
------------------------------------------------------------------------
0419/130.......  Documentation of       CMS/QIP
                  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
                  medications' name,
                  dosage, frequency
                  and route of
                  administration.
0565/191.......  Cataracts: 20/40 or    AMA-PCPI/NCQA
                  Better Visual Acuity
                  within 90 Days
                  Following Cataract
                  Surgery: Percentage
                  of patients aged 18
                  years and older with
                  a diagnosis of
                  uncomplicated
                  cataract who had
                  cataract surgery and
                  no significant
                  ocular conditions
                  impacting the visual
                  outcome of surgery
                  and had best-
                  corrected visual
                  acuity of 20/40 or
                  better (distance or
                  near) achieved
                  within 90 days
                  following the
                  cataract surgery.
0564/192.......  Cataracts:             AMA-PCPI/NCQA
                  Complications within
                  30 Days Following
                  Cataract Surgery
                  Requiring Additional
                  Surgical Procedures:
                  Percentage of
                  patients aged 18
                  years and older with
                  a diagnosis of
                  uncomplicated
                  cataract who had
                  cataract surgery and
                  had any of a
                  specified list of
                  surgical procedures
                  in the 30 days
                  following cataract
                  surgery which would
                  indicate the
                  occurrence of any of
                  the following major
                  complications:
                  retained nuclear
                  fragments,
                  endophthalmitis,
                  dislocated or wrong
                  power IOL, retinal
                  detachment, or wound
                  dehiscence.
0028/226.......  Preventive Care and    AMA-PCPI
                  Screening: Tobacco
                  Use: Screening and
                  Cessation
                  Intervention:
                  Percentage of
                  patients 18 years
                  and older who were
                  screened for tobacco
                  use one or more
                  times within 24
                  months AND who
                  received cessation
                  counseling
                  intervention if
                  identified as a
                  tobacco user.
N/A/303........  Cataracts:             AAO
                  Improvement in
                  Patient's Visual
                  Function within 90
                  Days Following
                  Cataract Surgery:
                  Percentage of
                  patients aged 18
                  years and older in
                  sample who had
                  cataract surgery and
                  had improvement in
                  visual function
                  achieved within 90
                  days following the
                  cataract surgery,
                  based on completing
                  a pre-operative and
                  post-operative
                  visual function
                  survey.
N/A/304........  Cataracts: Patient     AAO
                  Satisfaction within
                  90 Days Following
                  Cataract Surgery:
                  Percentage of
                  patients aged 18
                  years and older in
                  sample who had
                  cataract surgery and
                  were satisfied with
                  their care within 90
                  days following the
                  cataract surgery,
                  based on completion
                  of the Consumer
                  Assessment of
                  Healthcare Providers
                  and Systems Surgical
                  Care Survey.
N/A/388........  Cataract Surgery with  AAEECE/ACHS
                  Intra-Operative
                  Complications
                  (Unplanned Rupture
                  of Posterior Capsule
                  Requiring Unplanned
                  Vsitrectomy):
                  Rupture of the
                  posterior capsule
                  during anterior
                  segment surgery
                  requiring
                  vsitrectomy.
N/A/389........  Cataract Surgery:      AAEECE/ACHS
                  Difference Between
                  Planned and Final
                  Refraction:
                  Percentage of
                  patients who achieve
                  planned refraction
                  within +/-1,0 D.
------------------------------------------------------------------------


   Table 60--Chronic Kidney Disease (CKD) Measures Group for 2015 and
                                 Beyond
------------------------------------------------------------------------
                   Measure title and
    NQF/PQRS          description               Measure developer
------------------------------------------------------------------------
0326/047.......  Care Plan: Percentage  AMA-PCPI/NCQA
                  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.
0041/110.......  Preventive Care and    AMA-PCPI
                  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.
1668/121.......  Adult Kidney Disease:  AMA-PCPI
                  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.
N/A/122........  Adult Kidney Disease:  AMA-PCPI
                  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.
0419/130.......  Documentation of       CMS/QIP
                  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
                  medications' name,
                  dosage, frequency
                  and route of
                  administration.
0028/226.......  Preventive Care and    AMA-PCPI
                  Screening: Tobacco
                  Use: Screening and
                  Cessation
                  Intervention:
                  Percentage of
                  patients 18 years
                  and older who were
                  screened for tobacco
                  use one or more
                  times within 24
                  months AND who
                  received cessation
                  counseling
                  intervention if
                  identified as a
                  tobacco user.
------------------------------------------------------------------------


[[Page 67885]]


 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.]
------------------------------------------------------------------------
                   Measure title and
    NQF/PQRS          description               Measure developer
------------------------------------------------------------------------
0326/047.......  Care Plan: Percentage  AMA-PCPI/NCQA
                  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.
0091/051.......  Chronic Obstructive    AMA-PCPI
                  Pulmonary Disease
                  (COPD): Spirometry
                  Evaluation:
                  Percentage of
                  patients aged 18
                  years and older with
                  a diagnosis of COPD
                  who had spirometry
                  evaluation results
                  documented.
0102/052.......  Chronic Obstructive    AMA-PCPI
                  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
                  who were prescribed
                  an inhaled
                  bronchodilator.
0041/110.......  Preventive Care and    AMA-PCPI
                  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.
0043/111.......  Pneumonia Vaccination  NCQA
                  Status for Older
                  Adults: Percentage
                  of patients 65 years
                  of age and older who
                  have ever received a
                  pneumococcal vaccine.
0419/130.......  Documentation of       CMS/QIP
                  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
                  medications' name,
                  dosage, frequency
                  and route of
                  administration.
0028/226.......  Preventive Care and    AMA-PCPI
                  Screening: Tobacco
                  Use: Screening and
                  Cessation
                  Intervention:
                  Percentage of
                  patients 18 years
                  and older who were
                  screened for tobacco
                  use one or more
                  times within 24
                  months AND who
                  received cessation
                  counseling
                  intervention if
                  identified as a
                  tobacco user.
------------------------------------------------------------------------


  Table 62--Coronary Artery Bypass Graft (CABG) Measures Group for 2015
                               and Beyond
------------------------------------------------------------------------
                   Measure title and
    NQF/PQRS          description               Measure developer
------------------------------------------------------------------------
0134/043.......  Coronary Artery        STS
                  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.
0236/044.......  Coronary Artery        CMS/QIP
                  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.
0129/164.......  Coronary Artery        STS
                  Bypass Graft (CABG):
                  Prolonged
                  Intubation:
                  Percentage of
                  patients aged 18
                  years and older
                  undergoing isolated
                  CABG surgery who
                  require
                  postoperative
                  intubation > 24
                  hours.
0130/165.......  Coronary Artery        STS
                  Bypass Graft (CABG):
                  Deep Sternal Wound
                  Infection Rate:
                  Percentage of
                  patients aged 18
                  years and older
                  undergoing isolated
                  CABG surgery who,
                  within 30 days
                  postoperatively,
                  develop deep sternal
                  wound infection
                  involving muscle,
                  bone, and/or
                  mediastinum
                  requiring operative
                  intervention.
0131/166.......  Coronary Artery        STS
                  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.
0114/167.......  Coronary Artery        STS
                  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.
0115/168.......  Coronary Artery        STS
                  Bypass Graft (CABG):
                  Surgical Re-
                  Exploration:
                  Percentage of
                  patients aged 18
                  years and older
                  undergoing isolated
                  CABG surgery who
                  require a return to
                  the operating room
                  (OR) during the
                  current
                  hospitalization for
                  mediastinal bleeding
                  with or without
                  tamponade, graft
                  occlusion, valve
                  dysfunction, or
                  other cardiac
                  reason..
                 Please note that CMS
                  had proposed to
                  remove this measure
                  from the program and
                  thus this measure
                  group as a result in
                  the NPRM. However,
                  as noted above in
                  Table 55, CMS is not
                  finalizing its
                  proposal to remove
                  this measure, and as
                  such, the measure is
                  not being removed
                  from this measure
                  group either..
------------------------------------------------------------------------


   Table 63--Coronary Artery Disease (CAD) Measures Group for 2015 and
                                 Beyond
------------------------------------------------------------------------
                   Measure title and
    NQF/PQRS          description               Measure developer
------------------------------------------------------------------------
0067/006.......  Coronary Artery        AMA-PCPI/ACCF/AHA
                  Disease (CAD):
                  Antiplatelet
                  Therapy: Percentage
                  of patients aged 18
                  years and older with
                  a diagnosis of
                  coronary artery
                  disease seen within
                  a 12 month period
                  who were prescribed
                  aspirin or
                  clopidogrel.

[[Page 67886]]

 
0070/007.......  Coronary Artery        AMA-PCPI
                  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.
0421/128.......  Preventive Care and    CMS/QIP
                  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
                  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\.
0419/130.......  Documentation of       CMS/QIP
                  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
                  medications' name,
                  dosage, frequency
                  and route of
                  administration.
0028/226.......  Preventive Care and    AMA-PCPI
                  Screening: Tobacco
                  Use: Screening and
                  Cessation
                  Intervention:
                  Percentage of
                  patients 18 years
                  and older who were
                  screened for tobacco
                  use one or more
                  times within 24
                  months AND who
                  received cessation
                  counseling
                  intervention if
                  identified as a
                  tobacco user.
N/A/242........  Coronary Artery        AMA-PCPI/ACCF/AHA
                  Disease (CAD):
                  Symptom Management:
                  Percentage of
                  patients aged 18
                  years and older with
                  a diagnosis of
                  coronary artery
                  disease seen within
                  a 12 month period
                  with results of an
                  evaluation of level
                  of activity and an
                  assessment of
                  whether anginal
                  symptoms are present
                  or absent with
                  appropriate
                  management of
                  anginal symptoms
                  within a 12 month
                  period.
------------------------------------------------------------------------


          Table 64--Dementia Measures Group for 2015 and Beyond
------------------------------------------------------------------------
                   Measure title and
    NQF/PQRS          description               Measure developer
------------------------------------------------------------------------
0326/047.......  Care Plan: Percentage  AMA-PCPI/NCQA
                  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.
N/A/280........  Dementia: Staging of   AMA-PCPI
                  Dementia: Percentage
                  of patients,
                  regardless of age,
                  with a diagnosis of
                  dementia whose
                  severity of dementia
                  was classified as
                  mild, moderate or
                  severe at least once
                  within a 12 month
                  period.
N/A/281........  Dementia: Cognitive    AMA-PCPI
                  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.
N/A/282........  Dementia: Functional   AMA-PCPI
                  Status Assessment:
                  Percentage of
                  patients, regardless
                  of age, with a
                  diagnosis of
                  dementia for whom an
                  assessment of
                  functional status is
                  performed and the
                  results reviewed at
                  least once within a
                  12 month period.
N/A/283........  Dementia:              AMA-PCPI
                  Neuropsychiatric
                  Symptom Assessment:
                  Percentage of
                  patients, regardless
                  of age, with a
                  diagnosis of
                  dementia and for
                  whom an assessment
                  of neuropsychiatric
                  symptoms is
                  performed and
                  results reviewed at
                  least once in a 12
                  month period.
N/A/284........  Dementia: Management   AMA-PCPI
                  of Neuropsychiatric
                  Symptoms: Percentage
                  of patients,
                  regardless of age,
                  with a diagnosis of
                  dementia who have
                  one or more
                  neuropsychiatric
                  symptoms who
                  received or were
                  recommended to
                  receive an
                  intervention for
                  neuropsychiatric
                  symptoms within a 12
                  month period.
N/A/285........  Dementia: Screening    AMA-PCPI
                  for Depressive
                  Symptoms: Percentage
                  of patients,
                  regardless of age,
                  with a diagnosis of
                  dementia who were
                  screened for
                  depressive symptoms
                  within a 12 month
                  period.
N/A/286........  Dementia: Counseling   AMA-PCPI
                  Regarding Safety
                  Concerns: Percentage
                  of patients,
                  regardless of age,
                  with a diagnosis of
                  dementia or their
                  caregiver(s) who
                  were counseled or
                  referred for
                  counseling regarding
                  safety concerns
                  within a 12 month
                  period.
N/A/287........  Dementia: Counseling   AMA-PCPI
                  Regarding Risks of
                  Driving: Percentage
                  of patients,
                  regardless of age,
                  with a diagnosis of
                  dementia or their
                  caregiver(s) who
                  were counseled
                  regarding the risks
                  of driving and the
                  alternatives to
                  driving at least
                  once within a 12
                  month period.
N/A/288........  Dementia: Caregiver    AMA-PCPI
                  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.
------------------------------------------------------------------------


          Table 65--Diabetes Measures Group for 2015 and Beyond
------------------------------------------------------------------------
                   Measure title and
    NQF/PQRS          description               Measure developer
------------------------------------------------------------------------
0059/001.......  Diabetes: Hemoglobin   NCQA
                  A1c Poor Control:
                  Percentage of
                  patients 18-75 years
                  of age with diabetes
                  who had hemoglobin
                  A1c > 9.0% during
                  the measurement
                  period.
0041/110.......  Preventive Care and    AMA-PCPI
                  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.

[[Page 67887]]

 
0055/117.......  Diabetes: Eye Exam:    NCQA
                  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.
0062/119.......  Diabetes: Medical      NCQA
                  Attention for
                  Neuropathy: 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.
0056/163.......  Diabetes: Foot Exam:   NCQA
                  Percentage of
                  patients aged 18-75
                  years of age with
                  diabetes who had a
                  foot exam during the
                  measurement period.
0028/226.......  Preventive Care and    AMA-PCPI
                  Screening: Tobacco
                  Use: Screening and
                  Cessation
                  Intervention:
                  Percentage of
                  patients 18 years
                  and older who were
                  screened for tobacco
                  use one or more
                  times within 24
                  months AND who
                  received cessation
                  counseling
                  intervention if
                  identified as a
                  tobacco user.
------------------------------------------------------------------------


      Table 66--General Surgery Measures Group for 2015 and Beyond
------------------------------------------------------------------------
                   Measure title and
    NQF/PQRS          description               Measure developer
------------------------------------------------------------------------
0419/130.......  Documentation of       CMS/QIP
                  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
                  medications' name,
                  dosage, frequency
                  and route of
                  administration.
0028/226.......  Preventive Care and    AMA-PCPI
                  Screening: Tobacco
                  Use: Screening and
                  Cessation
                  Intervention:
                  Percentage of
                  patients 18 years
                  and older who were
                  screened for tobacco
                  use one or more
                  times within 24
                  months AND who
                  received cessation
                  counseling
                  intervention if
                  identified as a
                  tobacco user.
N/A/354........  Anastomotic Leak       ACS
                  Intervention:
                  Percentage of
                  patients aged 18
                  years and older who
                  required an
                  anastomotic leak
                  intervention
                  following gastric
                  bypass or colectomy
                  surgery.
N/A/355........  Unplanned Reoperation  ACS
                  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.
N/A/356........  Unplanned Hospital     ACS
                  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.
N/A/357........  Surgical Site          ACS
                  Infection (SSI):
                  Percentage of
                  patients aged 18
                  years and older who
                  had a surgical site
                  infection (SSI).
N/A/358........  Patient-Centered       ACS
                  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 received
                  personal discussion
                  of those risks with
                  the surgeon.
------------------------------------------------------------------------


     Table 67--Heart Failure (HF) Measures Group for 2015 and Beyond
------------------------------------------------------------------------
                   Measure title and
    NQF/PQRS          description               Measure developer
------------------------------------------------------------------------
0081/005.......  Heart Failure (HF):    AMA-PCPI/ACCF/AHA
                  Angiotensin-
                  Converting Enzyme
                  (ACE) Inhibitor or
                  Angiotensin Receptor
                  Blocker (ARB)
                  Therapy for Left
                  Ventricular Systolic
                  Dysfunction (LVSD):
                  Percentage of
                  patients aged 18
                  years and older with
                  a diagnosis of heart
                  failure (HF) with a
                  current or prior
                  left ventricular
                  ejection fraction
                  (LVEF) < 40% who
                  were prescribed ACE
                  inhibitor or ARB
                  therapy either
                  within a 12 month
                  period when seen in
                  the outpatient
                  setting OR at each
                  hospital discharge.
0083/008.......  Heart Failure (HF):    AMA-PCPI/ACCF/AHA
                  Beta-Blocker Therapy
                  for Left Ventricular
                  Systolic Dysfunction
                  (LVSD): Percentage
                  of patients aged 18
                  years and older with
                  a diagnosis of heart
                  failure (HF) with a
                  current or prior
                  left ventricular
                  ejection fraction
                  (LVEF) < 40% who
                  were prescribed beta-
                  blocker therapy
                  either within a 12
                  month period when
                  seen in the
                  outpatient setting
                  OR at each hospital
                  discharge.
0326/047.......  Care Plan: Percentage  AMA-PCPI/NCQA
                  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.
0041/110.......  Preventive Care and    AMA-PCPI
                  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..
0419/130.......  Documentation of       CMS/QIP
                  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
                  medications' name,
                  dosage, frequency
                  and route of
                  administration.
0028/226.......  Preventive Care and    AMA-PCPI
                  Screening: Tobacco
                  Use: Screening and
                  Cessation
                  Intervention:
                  Percentage of
                  patients 18 years
                  and older who were
                  screened for tobacco
                  use one or more
                  times within 24
                  months AND who
                  received cessation
                  counseling
                  intervention if
                  identified as a
                  tobacco user.
------------------------------------------------------------------------


[[Page 67888]]


        Table 68--Hepatitis C Measures Group for 2015 and Beyond
------------------------------------------------------------------------
                   Measure title and
    NQF/PQRS          description               Measure developer
------------------------------------------------------------------------
0395/084.......  Hepatitis C:           AMA-PCPI
                  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.
0396/085.......  Hepatitis C: HCV       AMA-PCPI
                  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 hepatitis C
                  virus (HCV) genotype
                  testing was
                  performed within 12
                  months prior to
                  initiation of
                  antiviral treatment.
0398/087.......  Hepatitis C:           AMA-PCPI
                  Hepatitis 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 whom
                  quantitative
                  hepatitis C virus
                  (HCV) RNA testing
                  was performed
                  between 4-12 weeks
                  after the initiation
                  of antiviral
                  treatment.
0419/130.......  Documentation of       CMS/QIP
                  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
                  medications' name,
                  dosage, frequency
                  and route of
                  administration.
0399/183.......  Hepatitis C:           AMA-PCPI
                  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.
0028/226.......  Preventive Care and    AMA-PCPI
                  Screening: Tobacco
                  Use: Screening and
                  Cessation
                  Intervention:
                  Percentage of
                  patients 18 years
                  and older who were
                  screened for tobacco
                  use one or more
                  times within 24
                  months AND who
                  received cessation
                  counseling
                  intervention if
                  identified as a
                  tobacco user.
N/A/401........  Screening for          AGA/AASLD/AMA-PCPI
                  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.
N/A/390........  Discussion and Shared  AGA/AASLD/AMA-PCPI
                  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
                  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 appropriate
                  to genotype, risks
                  and benefits,
                  evidence of
                  effectiveness, and
                  patient preferences
                  toward treatment.
------------------------------------------------------------------------


          Table 69--HIV/AIDS Measures Group for 2015 and Beyond
------------------------------------------------------------------------
                   Measure title and
    NQF/PQRS          description               Measure developer
------------------------------------------------------------------------
0326/047.......  Care Plan: Percentage  AMA-PCPI/NCQA
                  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.
0418/134.......  Preventive Care and    CMS/QIP
                  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.
0405/160.......  HIV/AIDS:              NCQA
                  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.
0409/205.......  HIV/AIDS: Sexually     AMA-PCPI/NCQA
                  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.
0028/226.......  Preventive Care and    AMA-PCPI
                  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.
2082/338.......  HIV Viral Load         HRSA
                  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
                  HIV viral load test
                  during the
                  measurement year.
2083/339.......  Prescription of HIV    HRSA
                  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.
2079/340.......  HIV Medical Visit      HRSA
                  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.
------------------------------------------------------------------------


[[Page 67889]]


 TABLE 70--Inflammatory Bowel Disease (IBD) Measures Group for 2015 and
                                 Beyond
------------------------------------------------------------------------
                   Measure title and
    NQF/PQRS          description               Measure developer
------------------------------------------------------------------------
0041/110.......  Preventive Care and    AMA-PCPI
                  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.
0043/111.......  Pneumonia Vaccination  NCQA
                  Status for Older
                  Adults: Percentage
                  of patients 65 years
                  of age and older who
                  have ever received a
                  pneumococcal vaccine.
0028/226.......  Preventive Care and    AMA-PCPI
                  Screening: Tobacco
                  Use: Screening and
                  Cessation
                  Intervention:
                  Percentage of
                  patients 18 years
                  and older who were
                  screened for tobacco
                  use one or more
                  times within 24
                  months AND who
                  received cessation
                  counseling
                  intervention if
                  identified as a
                  tobacco user.
N/A/270........  Inflammatory Bowel     AGA
                  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 600 mg
                  prednisone or
                  greater for all
                  fills that have been
                  prescribed
                  corticosteroid
                  sparing therapy in
                  the last reporting
                  year.
N/A/271........  Inflammatory Bowel     AGA
                  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 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.
N/A/274........  Inflammatory Bowel     AGA
                  Disease (IBD):
                  Testing for Latent
                  Tuberculosis (TB)
                  Before Initiating
                  Anti-TNF (Tumor
                  Necrosis Factor)
                  Therapy: Percentage
                  of patients aged 18
                  years and older with
                  a diagnosis of
                  inflammatory bowel
                  disease for whom a
                  tuberculosis (TB)
                  screening was
                  performed and
                  results interpreted
                  within 6 months
                  prior to receiving a
                  first course of anti-
                  TNF (tumor necrosis
                  factor) therapy.
N/A/275........  Inflammatory Bowel     AGA
                  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 1
                  year prior to
                  receiving a first
                  course of anti-TNF
                  (tumor necrosis
                  factor) therapy.
------------------------------------------------------------------------


          TABLE 71--Oncology Measures Group for 2015 and Beyond
------------------------------------------------------------------------
                   Measure title and
    NQF/PQRS          description               Measure developer
------------------------------------------------------------------------
0387/071.......  Breast Cancer:         AMA-PCPI/ASCO/NCCN
                  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.
0385/072.......  Colon Cancer:          AMA-PCPI/ASCO/NCCN
                  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.
0041/110.......  Preventive Care and    AMA-PCPI
                  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.
0419/130.......  Documentation of       CMS/QIP
                  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
                  medications' name,
                  dosage, frequency
                  and route of
                  administration.
0384/143.......  Oncology: Medical and  AMA-PCPI
                  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.
0383/144.......  Oncology: Medical and  AMA-PCPI
                  Radiation--Plan of
                  Care for Pain:
                  Percentage of visits
                  for patients,
                  regardless of age,
                  with a diagnosis of
                  cancer currently
                  receiving
                  chemotherapy or
                  radiation therapy
                  who report having
                  pain with a
                  documented plan of
                  care to address pain.
0028/226.......  Preventive Care and    AMA-PCPI
                  Screening: Tobacco
                  Use: Screening and
                  Cessation
                  Intervention:
                  Percentage of
                  patients 18 years
                  and older who were
                  screened for tobacco
                  use one or more
                  times within 24
                  months AND who
                  received cessation
                  counseling
                  intervention if
                  identified as a
                  tobacco user.
------------------------------------------------------------------------


  TABLE 72--Optimizing Patient Exposure to Ionizing Radiation Measures
                        Group for 2015 and Beyond
------------------------------------------------------------------------
                   Measure title and
    NQF/PQRS          description               Measure developer
------------------------------------------------------------------------
N/A/359........  Optimizing Patient     AMA-PCPI
                  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.

[[Page 67890]]

 
N/A/360........  Optimizing Patient     AMA-PCPI
                  Exposure to Ionizing
                  Radiation: Count of
                  Potential High Dose
                  Radiation Imaging
                  Studies: Computed
                  Tomography (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.
N/A/361........  Optimizing Patient     AMA-PCPI
                  Exposure to Ionizing
                  Radiation: Reporting
                  to a Radiation Dose
                  Index Registry:
                  Percentage of total
                  computed tomography
                  (CT) studies
                  performed for all
                  patients, regardless
                  of age, that are
                  reported to a
                  radiation dose index
                  registry AND that
                  include at a minimum
                  selected data
                  elements.
N/A/362........  Optimizing Patient     AMA-PCPI
                  Exposure to Ionizing
                  Radiation: Computed
                  Tomography (CT)
                  Images Available for
                  Patient Follow-up
                  and Comparison
                  Purposes: Percentage
                  of final reports for
                  computed tomography
                  (CT) studies
                  performed for all
                  patients, regardless
                  of age, which
                  document that
                  Digital Imaging and
                  Communications in
                  Medicine (DICOM)
                  format image data
                  are available to non-
                  affiliated external
                  entities on a
                  secure, media free,
                  reciprocally
                  searchable basis
                  with patient
                  authorization for at
                  least a 12-month
                  period after the
                  study.
N/A/363........  Optimizing Patient     AMA-PCPI
                  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) studies
                  performed for all
                  patients, regardless
                  of age, which
                  document that a
                  search for Digital
                  Imaging and
                  Communications in
                  Medicine (DICOM)
                  format images was
                  conducted for prior
                  patient CT imaging
                  studies completed at
                  non-affiliated
                  external healthcare
                  facilities or
                  entities within the
                  past 12-months and
                  are available
                  through a secure,
                  authorized, media
                  free, shared archive
                  prior to an imaging
                  study being
                  performed.
N/A/364........  Optimizing Patient     AMA-PCPI
                  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
                  incidentally
                  detected pulmonary
                  nodules (for
                  example, follow-up
                  CT imaging studies
                  needed or that no
                  follow-up is needed)
                  based at a minimum
                  on nodule size AND
                  patient risk factors.
------------------------------------------------------------------------


    Table 73--Parkinson's Disease Measures Group for 2015 and Beyond
------------------------------------------------------------------------
                   Measure title and
    NQF/PQRS          description               Measure developer
------------------------------------------------------------------------
0326/047.......  Care Plan: Percentage  AMA-PCPI/NCQA
                  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.
N/A/289........  Parkinson's Disease:   AAN
                  Annual Parkinson's
                  Disease Diagnosis
                  Review: All patients
                  with a diagnosis of
                  Parkinson's disease
                  who had an annual
                  assessment including
                  a review of current
                  medications (for
                  example, medications
                  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
                  levodopa, symmetry
                  at onset, rapid
                  progression [to
                  Hoehn and Yahr stage
                  3 in 3 years], lack
                  of tremor or
                  dysautonomia) at
                  least annually.
N/A/290........  Parkinson's Disease:   AAN
                  Psychiatric
                  Disorders or
                  Disturbances
                  Assessment: All
                  patients with a
                  diagnosis of
                  Parkinson's disease
                  who were assessed
                  for psychiatric
                  disorders or
                  disturbances (for
                  example, psychosis,
                  depression, anxiety
                  disorder, apathy, or
                  impulse control
                  disorder) at least
                  annually.
N/A/291........  Parkinson's Disease:   AAN
                  Cognitive Impairment
                  or Dysfunction
                  Assessment: All
                  patients with a
                  diagnosis of
                  Parkinson's disease
                  who were assessed
                  for cognitive
                  impairment or
                  dysfunction at least
                  annually.
N/A/292........  Parkinson's Disease:   AAN
                  Querying about Sleep
                  Disturbances: All
                  patients with a
                  diagnosis of
                  Parkinson's disease
                  (or caregivers, as
                  appropriate) who
                  were queried about
                  sleep disturbances
                  at least annually.
N/A/293........  Parkinson's Disease:   AAN
                  Rehabilitative
                  Therapy Options: All
                  patients with a
                  diagnosis 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.
N/A/294........  Parkinson's Disease:   AAN
                  Parkinson's Disease
                  Medical and Surgical
                  Treatment Options
                  Reviewed: All
                  patients with a
                  diagnosis of
                  Parkinson's disease
                  (or caregiver(s), as
                  appropriate) who had
                  the Parkinson's
                  disease treatment
                  options (for
                  example, non-
                  pharmacological
                  treatment,
                  pharmacological
                  treatment, or
                  surgical treatment)
                  reviewed at least
                  once annually.
------------------------------------------------------------------------


[[Page 67891]]


                          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  AMA-PCPI/NCQA
                            Women Aged 65 Years and Older:
                            Percentage of female patients aged 65
                            years and older who have a central dual-
                            energy X-ray absorptiometry (DXA)
                            measurement ordered or performed at
                            least once since age 60 or pharmacologic
                            therapy prescribed within 12 months.
N/A/48...................  Urinary Incontinence: Assessment of        AMA-PCPI/NCQA
                            Presence or Absence of Urinary
                            Incontinence in Women Aged 65 Years and
                            Older: Percentage of female patients
                            aged 65 years and older who were
                            assessed for the presence or absence of
                            urinary incontinence within 12 months.
0041/110.................  Preventive Care and Screening: Influenza   AMA-PCPI
                            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.
0043/111.................  Pneumonia Vaccination Status for Older     NCQA
                            Adults: Percentage of patients 65 years
                            of age and older who have ever received
                            a pneumococcal vaccine.
N/A/112..................  Breast Cancer Screening: Percentage of     NCQA
                            women 50 through 74 years of age who had
                            a mammogram to screen for breast cancer
                            within 27 months.
0034/113.................  Colorectal Cancer Screening: Percentage    NCQA
                            of patients 50 through 75 years of age
                            who had appropriate screening for
                            colorectal cancer.
0421/128.................  Preventive Care and Screening: Body Mass   CMS/QIP
                            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\.
0418/134.................  Preventive Care and Screening: Screening   CMS/QIP
                            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.
AQA Adopted/173..........  Preventive Care and Screening: Unhealthy   AMA-PCPI
                            Alcohol Use--Screening: Percentage of
                            patients aged 18 years and older who
                            were screened for unhealthy alcohol use
                            at least once within 24 months using a
                            systematic screening method**.
                           Please note that CMS had proposed to
                            remove this measure from the program and
                            thus this measure group as a result in
                            the NPRM. However, as noted above in
                            Table 55, CMS is not finalizing its
                            proposal to remove this measure, and as
                            such, the measure is not being removed
                            from this measure group either..
0028/226.................  Preventive Care and Screening: Tobacco     AMA-PCPI
                            Use: Screening and Cessation
                            Intervention: Percentage of patients 18
                            years and older who were screened for
                            tobacco use one or more times within 24
                            months AND who received cessation
                            counseling intervention if identified as
                            a tobacco user.
----------------------------------------------------------------------------------------------------------------


                     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         NCQA
                            Modifying Anti-Rheumatic Drug (DMARD)
                            Therapy: Percentage of patients aged 18
                            years and older who were diagnosed with
                            RA and were prescribed, dispensed, or
                            administered at least one ambulatory
                            prescription for a disease-modifying
                            anti-rheumatic drug (DMARD).
0421/128.................  Preventive Care and Screening: Body Mass   CMS/QIP
                            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\.
0420/131.................  Pain Assessment and Follow-Up: Percentage  CMS/QIP
                            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.
N/A/176..................  Rheumatoid Arthritis (RA): Tuberculosis    AMA-PCPI
                            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 first course of therapy
                            using a biologic disease-modifying anti-
                            rheumatic drug (DMARD).
N/A/177..................  Rheumatoid Arthritis (RA): Periodic        AMA-PCPI
                            Assessment of Disease Activity:
                            Percentage of patients aged 18 years and
                            older with a diagnosis of rheumatoid
                            arthritis (RA) who have an assessment
                            and classification of disease activity
                            within 12 months.
N/A/178..................  Rheumatoid Arthritis (RA): Functional      AMA-PCPI
                            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.
N/A/179..................  Rheumatoid Arthritis (RA): Assessment and  AMA-PCPI
                            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 disease prognosis
                            at least once within 12 months.

[[Page 67892]]

 
N/A/180..................  Rheumatoid Arthritis (RA): Glucocorticoid  AMA-PCPI
                            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.
----------------------------------------------------------------------------------------------------------------


         Table 76--Sinusitis Measures Group for 2015 and Beyond
------------------------------------------------------------------------
                   Measure title and
    NQF/PQRS          description               Measure developer
------------------------------------------------------------------------
0419/130.......  Documentation of       CMS/QIP
                  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
                  medications' name,
                  dosage, frequency
                  and route of
                  administration.
0420/131.......  Pain Assessment and    CMS/QIP
                  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.
0028/226.......  Preventive Care and    AMA-PCPI
                  Screening: Tobacco
                  Use: Screening and
                  Cessation
                  Intervention:
                  Percentage of
                  patients 18 years
                  and older who were
                  screened for tobacco
                  use one or more
                  times within 24
                  months AND who
                  received cessation
                  counseling
                  intervention if
                  identified as a
                  tobacco user.
N/A/331........  Adult Sinusitis:       AMA-PCPI
                  Antibiotic
                  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
                  within 10 days after
                  onset of symptoms.
N/A/332........  Adult Sinusitis:       AMA-PCPI
                  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 sinusitis
                  that were prescribed
                  amoxicillin, with or
                  without clavulante,
                  as a first line
                  antibiotic at the
                  time of diagnosis.
N/A/333........  Adult Sinusitis:       AMA-PCPI
                  Computerized
                  Tomography 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 the paranasal
                  sinuses ordered at
                  the time of
                  diagnosis or
                  received within 28
                  days after date of
                  diagnosis.
------------------------------------------------------------------------


        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.]
------------------------------------------------------------------------
                   Measure title and
    NQF/PQRS          description               Measure developer
------------------------------------------------------------------------
0421/128.......  Preventive Care and    CMS/QIP
                  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\.
0419/130.......  Documentation of       CMS/QIP
                  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
                  medications' name,
                  dosage, frequency
                  and route of
                  administration.
0028/226.......  Preventive Care and    AMA-PCPI
                  Screening: Tobacco
                  Use: Screening and
                  Cessation
                  Intervention:
                  Percentage of
                  patients 18 years
                  and older who were
                  screened for tobacco
                  use one or more
                  times within 24
                  months AND who
                  received cessation
                  counseling
                  intervention if
                  identified as a
                  tobacco user.
N/A/276........  Sleep Apnea:           AMA-PCPI/NCQA
                  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.
N/A/277........  Sleep Apnea: Severity  AMA-PCPI/NCQA
                  Assessment at
                  Initial Diagnosis:
                  Percentage of
                  patients aged 18
                  years and older with
                  a diagnosis of
                  obstructive sleep
                  apnea who had an
                  apnea hypopnea index
                  (AHI) or a
                  respiratory
                  disturbance index
                  (RDI) measured at
                  the time of initial
                  diagnosis.
N/A/278........  Sleep Apnea: Positive  AMA-PCPI/NCQA
                  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.
N/A/279........  Sleep Apnea:           AMA-PCPI/NCQA
                  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.
------------------------------------------------------------------------


[[Page 67893]]


   Table 78--Total Knee Replacement (TKR) Measures Group for 2015 and
                                 Beyond
------------------------------------------------------------------------
                   Measure title and
    NQF/PQRS          description               Measure developer
------------------------------------------------------------------------
0419/130.......  Documentation of       CMS/QIP
                  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
                  medications' name,
                  dosage, frequency
                  and route of
                  administration.
0028/226.......  Preventive Care and    AMA-PCPI
                  Screening: Tobacco
                  Use: Screening and
                  Cessation
                  Intervention:
                  Percentage of
                  patients 18 years
                  and older who were
                  screened for tobacco
                  use one or more
                  times within 24
                  months AND who
                  received cessation
                  counseling
                  intervention if
                  identified as a
                  tobacco user.
N/A/350........  Total Knee             AAHKS
                  Replacement: Shared
                  Decision-Making:
                  Trial of
                  Conservative (Non-
                  surgical) 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
                  (for example,
                  NSAIDS, analgesics,
                  weight loss,
                  exercise,
                  injections) prior to
                  the procedure.
N/A/351........  Total Knee             AAHKS
                  Replacement: Venous
                  Thromboembolic 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 Embolism,
                  Myocardial
                  Infarction,
                  Arrhythmia and
                  Stroke) and Stroke.
N/A/352........  Total Knee             AAHKS
                  Replacement:
                  Preoperative
                  Antibiotic Infusion
                  with Proximal
                  Tourniquet:
                  Percentage of
                  patients regardless
                  of age undergoing a
                  total knee
                  replacement who had
                  the prophylactic
                  antibiotic
                  completely infused
                  prior to the
                  inflation of the
                  proximal tourniquet.
N/A/353........  Total Knee             AAHKS
                  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
                  prosthetic implant
                  and the size of
                  prosthetic implant.
------------------------------------------------------------------------

e. Measures Available for Reporting in the GPRO Web Interface
    We finalized the measures that are available for reporting in the 
GPRO web interface for 2014 and beyond in the CY 2013 PFS final rule 
(77 FR 69269). However, we proposed 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 interface. 
CMS proposed to adopt Depression Remission at Twelve Months (NQF #0710) 
in the 2015 GPRO Web Interface reporting option 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 calendar years. 
Additionally, this measure requires 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 the 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 comments are 
addressed in Tables 79 and 80.
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f. The Clinician Group (CG) Consumer Assessment 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 we are now referring as 
the CAHPS for PQRS. Please note 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 Person and Caregiver-Centered 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 Caregiver-Centered Experience and 
Outcomes domain. We invited public comment on this proposal. Please 
note that the comments on this proposal are addressed in Table 54, 
where the domain change for CAHPS for PQRS as well as other PQRS 
measures is indicated.
6. Statutory Requirements and Other Considerations for the Selection of 
PQRS Quality Measures for Meeting the Criteria for Satisfactory 
Participation in a QCDR for 2014 and Beyond for Individual Eligible 
Professionals
    For the measures which eligible professionals participating 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 satisfactorily 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 the 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 period, 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 for satisfactory 
participation 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 2014 PFS final rule with comment period related to 
measures that may be reported by a QCDR (79 FR 40472 through 40473):
    <bullet> The QCDR must have at least 1 outcome measure available 
for reporting, which is a measure that assesses the results of health 
care that are experienced 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 participation criterion. Therefore, we proposed that 
a QCDR must have at least 3 outcome measures available for reporting, 
which is a measure that assesses the results of health care that are 
experienced by patients (that is, patients' clinical events; patients' 
recovery and health status; patients' experiences in the health system; 
and efficiency/cost). In lieu of having 3 outcome measures available 
for reporting, the QCDR must have at least 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 
satisfactory participation for the 2017 PQRS payment adjustment, for 
the same reasons, the majority of commenters also opposed our proposal 
to require that a QCDR must have at least 3 outcome measures available 
for reporting, or, in lieu of 3 outcome measures, a QCDR have at least 
2

[[Page 67903]]

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' concerns 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 reasons 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 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. To correspond with the final 
criteria for the satisfactory participation for 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 measure that assesses the results 
of health care that are experienced by patients (that is, patients' 
clinical events; 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/appropriate 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 use measure, or patient safety measure) in another domain 
available for reporting.
    We proposed to define resource use, patient experience of care, or 
efficiency/appropriate use measures in the following manner (79 FR 
40473):
    <bullet> 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.
    <bullet> A patient experience of care measure is a measure 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 provider 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.
    <bullet> 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 
which the potential for harm exceeds the possible benefits of care. We 
did not receive any comments this proposed definition of an efficiency/
appropriate use measure. 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 measure parameters we finalize. We noted that 
we would allow and encourage the reporting of the Consumer 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 
specifications for the measures for which it will report to CMS by no 
later than March 31, 2014. In keeping with this timeframe, we proposed 
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 measures data. We solicited and received the following comments 
on this proposal:
    Comment: Commenters believed that it was reasonable to require a 
QCDR to provide to CMS descriptions and narrative specifications for 
the measures for which it will report to CMS by no later than March 31, 
2014.
    Response: We appreciate the commenters' feedback. 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 measures data. For example, if a QCDR wishes to submit quality 
measures data for the 2017 PQRS payment 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 denominator, 
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 at http://www.cms.gov/apps/ama/license.asp?file=/PQRS/downloads/2014_PQRS_IndClaimsRegistry_MeasureSpecs_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 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 
provide 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. We believe providing this information will further aid in 
creating 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 made 
available to the public. The commenters supported our proposal to defer 
to the QCDR in terms of what platform and in what manner 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 urged CMS to delay requiring the posting of 
measures data until the measures have been tested for validity 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 reporting of QCDR quality measures data through a single site so 
that information would be easily accessible and people seeking this 
information would not be forced to look through multiple sites.
    Response: With respect to the commenters who opposed this proposal 
and urged us not to make additional changes to the QCDR option while 
entities become more familiar with this option, we understand the 
commenters'

[[Page 67904]]

concerns. However, we believe 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 revisit this proposed requirement as part of CY 2015 
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 Web site will provide quality measures data 
information on eligible professionals participating in QCDRs. 
Therefore, while the QCDRs are free to provide this information 
elsewhere, the Physician Compare Web site 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 post 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 provide 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 review 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 informal 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 respective 
claims begin to be adjusted due to the payment adjustment. However, 
because PQRS data is used to establish the quality composite of the VM, 
we believe it is necessary to expand the informal review 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 feedback reports. For 
example, if the feedback reports for the 2016 payment adjustment (based 
on data collected for 2014 reporting periods) were released on August 
31, 2015, an eligible professional 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 have 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 corrections to its PQRS data. This 
resubmitted data could then be used to make corrections to the VM 
calculations, when appropriate.
    The PQRS regulations at Sec.  414.90(m)(1) currently require an 
eligible professional or group practice to submit an informal review 
request to CMS within 90 days of the release of the feedback reports. 
Therefore, we proposed to revise Sec.  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 practice's ability 
to provide additional information to assist in the informal review 
process, we proposed to provide the following limitations as to what 
information might be taken into consideration:
    <bullet> 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.
    <bullet> CMS would only allow resubmission of data that 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 during the original 
submission period--would not be accepted.
    <bullet> For any given resubmission period, CMS would only accept 
data that was previously submitted for the reporting periods for which 
the corresponding 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 for 
data previously submitted for the 2017 PQRS payment adjustment 
reporting periods occurring in 2015.
    As such, we proposed to add Sec.  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 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. (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 reporting 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 identify 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 eligible professionals 
and group practices with a much shorter timeline with which to submit 
an informal review request. We also understand the commenters' concerns 
regarding having to access and 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 informal review request. In order to finalize 
our proposal to allow for the resubmission

[[Page 67905]]

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 resubmission of data. However, should we find that more time is 
needed to process resubmissions, we reserve the right to propose 
further changes to this deadline in future rulemaking. Therefore, for 
the reasons stated above and in the proposed rule, we are finalizing 
our proposal to modify Sec.  414.90(m)(1) to indicate the payment 
adjustment informal review deadline to within 60 days of the release of 
the feedback reports beginning in 2015.
    Comment: Several commenters generally supported our proposal to 
allow for resubmission of data.
    Response: We appreciate the commenters' support for this proposal. 
Based on the support for this proposal and for the reasons we stated in 
the proposed rule, we are finalizing our proposal to allow for 
resubmission of data as proposed. As we proposed, we are providing the 
following limitations as to what information might be taken into 
consideration:
    <bullet> CMS would only allow resubmission of data that was 
submitted by a third-party vendor on behalf of an eligible professional 
or group practice 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.
    <bullet> CMS would only allow resubmission of data that 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 during the original 
submission period--would not be accepted.
    <bullet> For any given resubmission period, CMS would only accept 
data that was previously submitted for the reporting periods for which 
the corresponding 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 for 
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 adjustment 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 Sec.  
414.90(m)(3) 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 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. (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 reporting periods for which the 
corresponding 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 eligible professionals (EPs) to 
report under the EHR Incentive Program, and in establishing the form 
and manner of reporting, the Secretary shall seek to avoid redundant or 
duplicative reporting otherwise required. As such, we have taken steps 
to establish alignments among various quality reporting and payment 
programs that include the submission of CQMs.
    For CY 2012 and subsequent years, Sec.  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 the 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 version of the electronic specifications 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 important for 
EPs to electronically report the most recent versions of the electronic 
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 data using the most 
recent version of the electronic specifications for the CQMs, it is 
important that the product be tested and certified to the most recent 
version of the electronic 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 
specifications for the CQMs. Although we still believe EPs should test 
and certify their products to the most recent version of the electronic 
specifications for the CQMs when feasible, we understand the burdens 
associated 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 products are recertified to the 
most recent version of the electronic specifications for the CQMs. 
Please note that, although we are not requiring recertification, EPs 
must still report the most recent version of the electronic 
specifications for the CQMs.
    In the CY 2014 PFS final rule with comment period, we established 
the requirement that EPs who seek to report CQMs electronically under 
the Medicare EHR Incentive 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 supported 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 some 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 view, 
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' support for this proposal. 
With respect to the commenter who opposed this proposal, we agree that 
it is important to recertify as frequently as possible for the reasons 
the commenter stated. However, at this time, we understand that 
requiring recertification to the most recent version of the electronic 
specifications for the CQMs, which could occur annually, may be overly 
burdensome and time-consuming

[[Page 67906]]

for providers. Please note that this proposal was 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 proposal 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 requiring recertification, EPs must 
still report the most recent version of the electronic specifications 
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) Positive 
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 report this measure 
electronically under the EHR Incentive Program in CY 2014, the prior, 
December 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 recent, updated 
version of the measure Breast Cancer Hormonal Therapy for Stage IC-IIIC 
Estrogen Receptor/Progesterone Receptor (ER/PR) Positive Breast Cancer 
(NQF 0387), if an EP chooses to report the measure electronically in CY 
2015.
    In the EHR Incentive Program Stage 2 final rule, we established CQM 
reporting options for the Medicare EHR Incentive Program for CY 2014 
and subsequent 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 and Medicare Shared 
Savings Program (MSSP) and Pioneer ACOs (77 FR 54076 to 54078). In the 
CY 2014 PFS final rule with comment period, we finalized two additional 
aligned options for EPs to report CQMs for the Medicare EHR Incentive 
Program for CY 2014 and 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 Medicare EHR Incentive Program under which EPs can submit 
CQM information using qualified clinical data registries, according the 
definition and requirements for qualified 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 reporting 
option for CQMs for the Medicare EHR Incentive Program beginning in CY 
2014 under which EPs who are part of a Comprehensive Primary Care (CPC) 
initiative practice site that successfully reports at least nine 
electronically specified CQMs across three domains for the relevant 
reporting period in accordance with the requirements established for 
the CPC initiative and using CEHRT would satisfy the CQM reporting 
component of meaningful use for the Medicare EHR Incentive Program. If 
a CPC practice site is not successful in reporting, EPs who are part of 
the site would still have the opportunity to report CQMs in accordance 
with the requirements established for the Medicare EHR Incentive 
Program in the Stage 2 final rule. 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 electronic submission or attestation of CQMs, the 
CPC practice site must submit the CQM data in the form and manner 
required by the CPC initiative.
    The CPC initiative, under the authority of section 3021 of the 
Affordable Care Act, is a multi-payer initiative fostering 
collaboration between 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, coordinated services. Simultaneously, participating 
commercial, state, and other federal insurance plans are also offering 
enhanced support to primary care practices that provide high-quality 
primary care. There are approximately 483 CPC practice sites across 7 
health care markets in the U.S. More details on the CPC initiative can 
be found at http://innovation.cms.gov/initiatives/Comprehensive-Primary-Care-Initiative/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 rule for EPs to report under 
the EHR Incentive Program beginning in CY 2014, see 77 FR 54069 through 
54075). We proposed to retain the group reporting option for CPC 
practice sites as finalized in the CY 2014 PFS final rule, but to relax 
the requirement for the CQMs to cover three 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 sites to report across more 
domains if feasible. Although the requirement to report across three 
domains is important because the domains are linked to the National 
Quality Strategy and used throughout CMS quality programs, the CPC 
practice sites are required 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, 
CPC practice sites are assessed for quality performance on measures 
other than electronically specified CQMs which do cover other National 
Quality 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, indicating 
providers should be able to select the measures most applicable to 
their population.
    Response: We appreciate the support for this proposal. The CPC CQM 
set targets a primary care patient population and therefore is 
appropriate for reporting by CPC practice sites in the model.
    Comment: One commenter opposed relaxing 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 domains reported electronically. 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 
quality measure reporting requirements for each CPC practice site to be 
eligible to participate in any Medicare shared savings, which is a 
component of the model. The

[[Page 67907]]

quality reporting requirements include reporting on a subset of the 
CQMs selected for the EHR Incentive 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 
health domain, and 1 in the safety domain. We proposed to reduce the 
number of domains required to at least 2 domains to allow CPC practice 
sites that would be unable to obtain in their EHR the one safety CQM in 
the CPC measure subset to meet the MU CQM requirement. This would 
provide CPC practice sites an opportunity to successfully report to the 
CPC model and satisfy the CQM reporting 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 comments received, and for the reasons 
stated previously, we are finalizing the proposal to reduce the 
required number of domains for CY 2015 only as proposed.

M. Medicare Shared Savings Program

    Under section 1899 of the Act, CMS has established 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 ambulatory 
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 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 the purposes of assessing the 
quality of care. Additionally, section 1899(b)(3)(D) of the Act gives 
the Secretary authority to incorporate reporting requirements and 
incentive payments related to the PQRS, EHR Incentive Program and other 
similar initiatives under section 1848 of the Act. Finally, section 
1899(d)(1)(A) of the Act states that an ACO is eligible to receive 
payment for shared savings, if they are generated, only after meeting 
the quality performance standards established by the Secretary.
    In the November 2011 final rule establishing the Shared Savings 
Program, we established the quality performance standards that ACOs 
must meet to be eligible 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 group 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 directive under section 1899(b)(3)(C) of the 
Act, we believe the existing Shared Savings Program regulations 
incorporate a built in mechanism for encouraging ACOs to improve care 
over the course of their 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 
accurately reporting all quality measures. After that, ACOs must meet 
certain thresholds of performance, which are currently phased in over 
the course of the ACO's first agreement period, and are rewarded for 
improved performance on a sliding scale in which higher levels of 
quality performance translate to higher rates of shared savings (or, 
for ACOs subject to performance-based risk that demonstrate losses, 
lower rates of shared losses). In this way, the quality performance 
standard increases 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 Savings 
Program with the PQRS. Eligible professionals participating in an ACO 
may qualify for the PQRS incentive payment under the Shared Savings 
Program or avoid the downward PQRS payment adjustment when the ACO 
satisfactorily reports the ACO GPRO measures on their behalf using the 
GPRO web interface.
    Since the November 2011 final rule establishing the Shared Savings 
Program was issued, we have revisited certain aspects of the quality 
performance standard in the annual PFS rulemaking out of a desire to 
ensure thoughtful alignment with the agency's other quality incentive 
programs that are addressed in that rule. 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 Physician 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 the current quality performance 
standard, proposed changes to the quality measures, 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 corrections to the regulations in subpart 
F of Part 425.
1. Existing Quality Measures and Performance Standard
    As discussed previously, section1899(b)(3)(C) of the Act states 
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 November 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 interface, calculated by CMS from 
administrative and claims data, and collected via a patient experience 
of care survey based on the Clinician and Group Consumer Assessment of 
Healthcare Providers and Systems (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,

[[Page 67908]]

care coordination/patient safety, preventive health, and at-risk 
population. The measures collected through the GPRO web interface are 
also used to determine whether eligible professionals participating 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 
newly 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 short-term measurable outcomes derived 
from administrative claims and limited medical record review 
facilitated 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-based, target conditions of high 
cost and high prevalence in the Medicare FFS population, reflect 
priorities of the National Quality Strategy, address the continuum of 
care to reflect the requirement that ACOs accept accountability for 
their patient populations, and align with existing 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 services or utilization since we believe that the 
potential to earn shared savings offers an important 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 
performance in these areas. For example, an assessment of an ACO's 
utilization of certain resources is provided to the ACO via quarterly 
reports that contain information such as the utilization of emergency 
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 also exercised our discretion to 
include certain measures that we believe to be high impact but that are 
not currently endorsed, for example, ACO#11, Percent of PCPs Who 
Successfully Qualify for an EHR Incentive Program Payment.
    In selecting the final set of 33 measures, we sought to include 
both process and outcome measures, including patient experience of care 
(76 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 
outcomes 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 revise the quality 
performance standard for the Shared Savings Program to incorporate more 
outcomes-based measures over time.
    Therefore, we viewed the 33 measures adopted in the November 2011 
Shared Savings Program final rule as a starting point 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 quality of care and to continue aligning with other 
quality reporting programs and will add and/or retire measures 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 Shared Savings Program are 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 Quality Strategy and to 
emphasize the importance of ambulatory 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 for 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 Program 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 
practice and are aligned with the GPRO web interface reporting for 
PQRS. Based on these reviews, in the CY 2015 Physician Fee 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 through 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 measures 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 
would 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 by measures

[[Page 67909]]

that would be calculated by CMS using administrative claims data or 
from a patient survey. The total number of measures that the ACO would 
need to directly report through the CMS Web site 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 measure with a new four 
component diabetes composite measure. In addition, we proposed to 
replace the current two component coronary artery disease composite 
measure with a new four component coronary artery disease composite 
measure. Under this proposal, 21 measures would be reported by ACOs 
through the GPRO web interface and scored as 15 measures.
    Below, we summarize and group comments 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 proposed rule (79 FR 40479 through 40481) (that is, survey, claims, 
EHR incentive program, and the CMS web interface). In order to align 
the measures submitted through the CMS web interface 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 quality measures. Some commenters objected to the 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, suggesting, 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 
inadequately defined, tested or benchmarked. These ACOs believed that 
many of the proposed new measures address clinical issues beyond an 
ACO's control and therefore should not be added. Other concerns about 
the new measures were that they would require substantial change in 
clinical practice, would substantially add to the reporting burden, 
and/or are questionably related 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 management measures that our developing ACO would have 
likely considered and built into our ACO Cost, Utilization, and Risk 
dashboard anyway. From a clinical and system standpoint, these 
additions are key components of better managing avoidable utilization 
and costs. They are measures we would want to know regardless of the 
Proposed Rule.'' MedPAC suggested that CMS move quality measurement for 
ACOs, MA plans, and FFS Medicare 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 appropriate to add, remove, 
and modify quality measures for the Shared Savings Program to reflect 
changes in clinical practice and for other program needs. We want to 
minimize any additional burdens this could create for ACOs and their 
ACO participants and ACO providers/suppliers. Therefore, we agree with 
the comments in support of the alignment between ACO, PQRS and VM for 
the quality measures submitted through the CMS web interface, and an 
increased focus on outcomes-based quality measures. We disagree with 
those ACOs that suggested certain proposed new 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 utilization and costs. Further, we 
believe certain proposed new measures highlight the value of 
discussions with patients about their care.
b. Survey Based Measure
    <bullet> 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 Resources 
measure asks the patient whether the care team talked with the patient 
about prescription medicine costs. 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 Stewardship 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 beneficiary's 
engagement and experience with healthcare providers. We also proposed 
that the measure would 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 used to assess ACO quality performance.
    Comment: Some commenters supported the proposed addition of this 
measure, agreeing that discussing the cost of medications is important 
to assess the possibility that medication costs may be a barrier to 
care or that the measure may be an indicator of a patient's 
satisfaction with the care he or she is receiving. Other commenters 
questioned how this discussion leads to a plan of action or a modified 
plan of treatment to improve care if the patient is unable to pay for 
the medication. These commenters asked us to further explain how we 
envision this measure improving patient care. Some believe 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 
relatively new measure. Some thought that physician discussions with 
patients regarding medication cost would be appropriate for ``high 
tier,'' costly medications, but would be of questionable value 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 would 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 and that there would be tremendous patient dissatisfaction 
when inaccurate pricing or cost information is provided to the patient 
by the provider. Some

[[Page 67910]]

commenters believe this measure is unnecessary since encouraging 
adherence to medications is a key strategy for ACOs to reduce avoidable 
costs, and inability to afford medications is a key barrier to 
adherence, so ACOs already have an incentive to discuss the cost of 
medications with their patients.
    Response: This measure asks patients whether any health care 
provider spoke to them about their prescription medication costs and 
does not require that physicians know the co-pays for each drug under 
each insurance plan and product. Additionally, discussing this topic 
with beneficiaries can lead a clinician to understand whether and how 
the beneficiary may struggle with payment for medications, a factor 
that can affect adherence to prescribed regimens. We can therefore 
envision a scenario where, once the issue is identified, a clinician 
participating in an ACO could inform and educate the beneficiary about 
less expensive options, such as the use of generic medications, or 
about available community resources, as part of the ACO's care 
coordination processes required under Sec.  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 measure is already part of the CAHPS survey, 
we do not believe it will increase reporting burden for the ACO. The 
CAHPS survey question is available in the CAHPS Survey for ACOs Quality 
Assurance Guidelines on the CAHPS for ACOs Web site. As discussed 
below, because this is a new measure, the measure will be pay-for-
reporting for the first two reporting periods it is in use for all 
ACOs, regardless of the phase-in schedule to pay-for-performance, in 
order to provide time for the development of an appropriate benchmark.
    Final Decision: We are finalizing our proposed addition of the 
CAHPS: Stewardship of Patient Resources measure. After the measure 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 that it is 
important for physicians and others to discuss the beneficiary's 
perspective on the cost of medications because is important to assess 
the possibility that medication costs may be a barrier to care. 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.
c. Claims Based Measures To Be Computed by CMS
    <bullet> Skilled Nursing Facility 30-Day All-Cause 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 measure, which is under review at NQF under NQF #2510. 
This measure estimates the risk-standardized rate of all-cause, 
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 believe this measure would help 
fill a gap in the current Shared Savings Program measure set and 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 organization, ACO 
providers/suppliers furnish other services that have the potential to 
affect PAC outcomes. Thus, this measure would emphasize the importance 
of coordinating the care of beneficiaries across these 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-adjusted measure of potentially 
avoidable readmissions for SNFs. Although MedPAC recommended that CMS 
consider a risk-adjusted, potentially avoidable readmission measure for 
SNFs, they did support the addition of a SNF readmission measure 
because of the importance of post-acute care management and care 
transitions between settings in improving beneficiary 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 SNFs would bear risk/penalty equal to that of 
other providers in order to incent readmissions reduction. Some 
commenters believe that it is unnecessary and duplicative to add this 
quality measure since it is an inherent part of the Shared Savings 
Program that an ACO will be penalized through a reduction in shared 
savings if it has a high rate of readmissions. They also argue that 
ACOs that use SNFs for higher-acuity patients could see an increase in 
SNF readmission rates and thus be inappropriately penalized. A 
commenter suggested ACO scores will be inappropriately affected when 
beneficiaries return to an ACO participant hospital after being 
discharged to a SNF that is not participating in the ACO. In such 
cases, an ACO may be unable to achieve the same level of collaboration 
needed to affect change as compared to ACOs that include one or more 
SNFs as ACO 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 use and 
disclosure of documentation regarding drug and substance abuse as well 
as mental health therapies. These commenters recommend removing 
psychiatric hospital admissions from this measure since ACOs currently 
do not receive mental health claims 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 including 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 improving performance 
against benchmarks unless CMS provides the algorithm to apply the 
appropriate risk adjustment. These commenters indicate that ACOs face 
significant challenges in monitoring performance when reliable risk-
adjusted rates of admissions and readmissions are not provided on a 
regular basis.
    Response: We appreciate the numerous thoughtful comments. We 
disagree with commenters that this measure is unnecessary and 
duplicative because we continue to believe that including this measure 
would reinforce the importance 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 these sites regardless of whether there are any 
post-acute care (PAC) providers participating in the ACO (Sec.  
425.112(b)(4)). Even when the ACO

[[Page 67911]]

does not include post-acute facilities formally as ACO participants or 
ACO providers/suppliers, ACO providers/suppliers furnish other services 
that have the potential to affect PAC outcomes. Thus, this measure 
would emphasize the importance of coordinating the care of 
beneficiaries across these sites of care. Additionally, because this 
measure is calculated from claims, there would not be a reporting 
burden on ACOs to collect 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 all-cause readmission 
measure does exclude planned readmissions using a similar methodology 
to ACO-8 Risk-Standardized, All Condition Readmission. Unplanned 
readmission rates do provide ACOs with useful information to better 
coordinate care and work toward reducing the risk of readmissions for 
all patients, including 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 
HIPAA Privacy Rule and sharing information related to mental health, 
available at http://www.hhs.gov/ocr/privacy/hipaa/understanding/special/mhguidance.html. Thus, ACOs that request claims data under 
Sec.  425.704 for purposes of their own health care operations or the 
health care operations of their covered entity ACO participants and ACO 
providers/suppliers, in accordance with HIPAA requirements, already 
receive information about mental health therapies as part of those data 
sets.
    Final Decision: We are finalizing our proposal 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 will transition to pay-for-
performance in the final year of the ACO's agreement period. We believe 
this 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.
    <bullet> All-Cause Unplanned Admissions for Patients 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 Mellitus (DM), all-cause 
unplanned Admissions for Patients with Heart Failure (HF) and all-cause 
unplanned Admissions for Patients with Multiple Chronic Conditions 
(MCC). These three measures 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 
specifically 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 because 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 expect 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 All-Cause 
Unplanned Admissions for Patients with DM, HF and MCC.
    Comment: We received a wide variety of comments in response to the 
proposal to add these claims-based measures. Many commenters 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 supported adding one or more of these 
measures, agreeing that chronic condition inpatient admissions are 
major causes for unplanned admissions and that the addition of one or 
more of these 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 better patient outcomes and control cost. Another commenter 
supported the measures but preferred collapsing them into one measure 
of potentially avoidable hospitalizations, because of concern that the 
proposed condition-specific measures will be statistically unreliable 
and subject to random variation that will limit their usefulness in 
distinguishing ACOs' actual performance. In addition, some commenters 
urged CMS to ensure the measures are adjusted for planned readmissions, 
unrelated readmissions and socio-demographic status. Other commenters 
supported applying these measures in the Shared Savings Program as pay 
for reporting only at this time since these measures are still under 
development, accepted target rates are not available and the measures 
are not yet endorsed by NQF. Commenters requested additional definition 
of what ``other multiple chronic conditions'' would be measured. MedPAC 
supported an increase of outcome measures. Finally, some commenters 
believe it is not possible to comment on measures that are still under 
development, and questioned the added benefit of including these 
measures since ACOs have an inherent incentive to avoid or reduce 
unplanned hospital admissions.
    Response: We continue to believe that these measures are important 
to promote and assess ACO quality because 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 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 
regarding the lack of NQF endorsement, but CMS intends on submitting 
all three measures to NQF for review in the future. Draft measure 
specifications were made available to the public during the measure 
development comment period during the spring and summer of 2014. CMS 
will provide final measure specifications to the public when available 
(typically in the early part of the performance year). The MCC measure 
cohort definition aligns with the NQF MCC Measurement Framework, which 
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 functional roles and health 
outcomes, compromise life expectancy, or hinder self-management.'' \11\ 
The MCC measure cohort of chronic conditions includes conditions such 
as, but not limited to, Acute Myocardial Infarction, Stroke, and 
Chronic Obstructive Pulmonary Disease.
---------------------------------------------------------------------------

    \11\ National Quality Forum (NQF). Multiple Chronic Conditions 
Measurement Framework. 2012; http://www.qualityforum.org/WorkArea/linkit.aspx?LinkIdentifier=id&ItemID=71227.
---------------------------------------------------------------------------

    Final Decision: After considering the comments received in response 
to our

[[Page 67912]]

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 first 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 these measures in the Shared Savings Program measure set 
since they were specifically developed 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 
Medicare 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
    <bullet> 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 name 
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 regarding this proposal. 
Some agreed that it is necessary to rename the measure given that the 
EHR Incentive Program begins its transition to a payment adjustment 
effective in 2015. Some of the commenters, while agreeing with the 
proposed change, also provided additional specification suggestions 
such as to exclude certain physicians, such as hospitalists, from the 
denominator of this measure, stating that hospitalists are not PCPs 
when providing observation services. Another commenter requested that 
CMS clarify ``the interaction of the Medicaid Meaningful 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 why 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 opportunity to exclude physicians such as those who 
retired, died, moved out the country, from the denominator of this 
measure. Finally, there 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 measure has no direct 
relationship 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 and renamed 
given that downward adjustments to Medicare payments will begin in 2015 
under the EHR Incentive Program. We appreciate the suggestions from 
commenters that agree with the proposed change and provided additional 
specification suggestions. We are not persuaded 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 and 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 efficiency of care. The measure 
specifications will continue to align with the EHR Incentive Program 
definitions of hospital-based providers and will exclude observation 
services, accordingly. The measure specifications include Medicare and 
Medicaid eligible PCPs. Practitioners 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 support the adoption and 
meaningful use of certified EHR technology. For example, the HHS Office 
of the National Coordinator 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 records (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 qualified for EHR incentive 
payments for using certified EHR technology. Retaining this measure in 
the quality performance standard for the Shared Savings Program will 
help provide an additional and appropriate incentive to reinforce the 
adoption and meaningful use of certified EHR technology. Finally, 
performance on this measure is determined using EHR Incentive Program 
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.
---------------------------------------------------------------------------

    \12\ http://www.hhs.gov/news/press/2014pres/09/20140916a.html.
---------------------------------------------------------------------------

    Final Decision: After consideration of the comments received, we 
are finalizing the proposal to modify the name and specifications of 
ACO-11 to the Percent of PCPs who successfully meet MU requirements.
e. Measures Submitted Through the CMS Web Interface
    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:
    <bullet> Depression Remission at Twelve Months (NQF #0710).
    <bullet> Diabetes Measures for Foot Exam and Eye Exam (NQF #0056 
and #0055).
    <bullet> Coronary Artery Disease (CAD): Symptom Management.
    <bullet> Coronary Artery Disease (CAD): Beta Blocker Therapy--Prior 
Myocardial Infarction (MI) or Left Ventricular Systolic Dysfunction 
(LVEF<40%) (NQF #0070).
    <bullet> Coronary Artery Disease (CAD): Antiplatelet Therapy (NQF 
#0067).
    <bullet> Documentation of Current Medications in the Medical Record 
(NQF #0419).
    Additionally, we identified a number of the existing measures 
submitted through the CMS web interface that have not kept up with 
clinical best practice, are redundant with other measures that make up 
the quality performance standard, or that could be replaced by similar 
measures that are more appropriate for ACO quality reporting. For the 
reasons specified in the proposed rule, we proposed to no longer 
collect data on the following measures, and these measures would no 
longer be used for establishing the quality performance standards that 
ACOs must meet to be eligible to share in savings:
    <bullet> ACO #12, Medication Reconciliation after Discharge from an 
Inpatient Facility.
    <bullet> ACO #22, Diabetes Composite measure: Hemoglobin A1c 
control (<8 percent).
    <bullet> ACO #23, Diabetes Composite: Low Density Lipoprotein 
(<100) (NQF #0729).
    <bullet> ACO #24, Diabetes Composite: Blood Pressure (<140/90) (NQF 
#0729).

[[Page 67913]]

    <bullet> ACO #25, Diabetes Composite: Tobacco Non-use (NQF #0729).
    <bullet> ACO #29, Ischemic Vascular Disease: Complete Lipid Profile 
and LDL Control (<100 mg/dl) (NQF #0075).
    <bullet> ACO #30, Ischemic Vascular Disease: Use of Aspirin or 
another Antithrombotic (NQF #0068).
    <bullet> 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 measures. We proposed that 
the Diabetes Composite include the following measures:
    <bullet> ACO #26: Diabetes Mellitus: Daily Aspirin or Antiplatelet 
Medication Use for Patients with Diabetes Mellitus and Ischemic 
Vascular Disease.
    <bullet> ACO #27: Diabetes: Hemoglobin A1c Poor Control.
    <bullet> ACO #41: Diabetes: Foot Exam.
    <bullet> ACO #42: Diabetes: Eye Exam.
    We further proposed that the CAD Composite include the following 
measures:
    <bullet> ACO #33: Angiotensin-Converting Enzyme (ACE) Inhibitor or 
Angiotensin Receptor Blocker (ARB) Therapy--Diabetes or Left 
Ventricular Systolic Dysfunction (LVEF<40%).
    <bullet> ACO #43: Antiplatelet Therapy.
    <bullet> ACO #44: Symptom Management.
    <bullet> ACO #45: Beta-Blocker Therapy--Prior Myocardial Infarction 
(MI) or Left Ventricular Systolic Dysfunction (LVEF<40%).
    We solicited comment on these composite measures and whether there 
are any concerns regarding the calculation of a composite score. Given 
the general concerns around composite 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 least 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 raised 
general clinical or other methodological concerns about individual 
proposed measures submitted through the CMS web interface. Our detailed 
responses to those comments can be found in Table 79 of section III.K. 
of this final rule with comment period.
    We do, however, wish to note some specific comments relevant to our 
final policy decisions with respect to the quality performance measures 
used in the Shared Savings Program: (1) Commenters noted that the 
Patient Health Questionnaire 9 (PHQ-9) is specified for use in the 
Depression Remission measure (proposed ACO # 40), and that this tool is 
only one of several options available to practitioners. These 
commenters 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. Additionally, 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 measure (proposed ACO # 44), 
stating they believe the measure lack primary care focus and that there 
are potential challenges in data collection. CMS also received a 
comment supporting the proposed addition 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 commenters 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 these 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 preventive health measures) 
that are generalizable across providers and care settings, rather than 
measures that target specific providers or care settings.
    Response: We continue to believe that the quality performance 
measures used in the Shared Savings Program should reflect current 
clinical guidelines. We appreciate the commenters' agreement with our 
proposed changes 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 erroneously made the assertion that this measure 
conflicts with current clinical guidelines. Therefore, due to the 
clinical importance of the measure, the measurement gap it addresses, 
and 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-performance during the second and third 
performance years of an ACO's first agreement period. We will, however, 
finalize our proposal to use the measure to assess ACO quality, 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 tools other than the PHQ-9, 
while providing the opportunity for ACOs to begin adopting this tool 
without harming their ability to achieve full points on the measure. 
Additionally, 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 comments received and in order to align 
with the final measures that will be used in the PQRS program, we will 
not finalize the CAD: Symptom Management (proposed ACO-44) and CAD: 
Antiplatelet Therapy (proposed ACO-43) measures for the Shared Savings 
Program. See 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 which requires the Secretary to determine 
appropriate measures to assess the quality of care furnished by the 
ACO, reflect current clinical practice, promote high quality care, and 
alignment with PQRS and National Quality Strategy. We therefore 
disagree with commenters that internal operational challenges that 
arise from changes in the measure set outweigh the benefit of such 
changes.
    After considering the comments received regarding the proposed new 
measures, we are finalizing our proposal to add the following new 
measures that will be submitted by the ACO through the CMS web 
interface:

[[Page 67914]]

    <bullet> Documentation of Current Medications in the Medical Record 
(NQF #0419).
    <bullet> Depression Remission at Twelve Months (NQF #0710).
    <bullet> Diabetes Measures for Eye Exam (NQF #0055).
    For the reasons stated in section III.K., we decline to finalize 
our proposals to add the following measures:
    <bullet> Diabetes: Foot Exam (NQF #0056)
    <bullet> CAD: Antiplatelet Therapy (NQF #0067)
    <bullet> CAD: Symptom Management
    <bullet> CAD: Beta-Blocker Therapy--Prior Myocardial Infarction or 
Left Ventricular Systolic Dysfunction (LVSD) (NQF #0070)
    We are not finalizing our proposal to add the CAD: Antiplatelet 
Therapy (NQF #0067) measure and instead will keep the measure it was 
designed to replace, ACO #30, Ischemic Vascular Disease: Use of Aspirin 
or another Antithrombotic (NQF #0068) because we have determined that 
it does not conflict with clinical guidelines, remains clinically 
important, addresses a measurement gap, and aligns with the Million 
Hearts Campaign 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 finalizing our proposal to remove certain 
measures from the ACO quality performance standard including the 
following:
    <bullet> ACO #12, Medication Reconciliation after Discharge from an 
Inpatient Facility.
    <bullet> ACO #22, Diabetes Composite measure: Hemoglobin A1c 
control (<8 percent).
    <bullet> ACO #23, Diabetes Composite: Low Density Lipoprotein 
(<100) (NQF #0729).
    <bullet> ACO #24, Diabetes Composite: Blood Pressure (<140/90) (NQF 
#0729).
    <bullet> ACO #25, Diabetes Composite: Tobacco Non-use (NQF #0729).
    <bullet> ACO #29, Ischemic Vascular Disease: Complete Lipid Profile 
and LDL Control (<100 mg/dl) (NQF #0075).
    <bullet> ACO #32, Coronary Artery Disease (CAD) Composite: Drug 
Therapy for Lowering LDL Cholesterol (NQF #74).
    Finally, given these changes, we are revising the Diabetes 
Composite to include the following measures:
    <bullet> ACO #27: Diabetes: Hemoglobin A1c Poor Control (NQF 
#0059).
    <bullet> ACO #42: Diabetes: Eye Exam (NQF #0055).
    Although not previously proposed, in order to align with PQRS and 
in response to commenter concerns about using this measure outside the 
composite, we are removing ACO #26, Diabetes Mellitus: Daily Aspirin or 
Antiplatelet Medication Use 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 raised by 
commenters as discussed in Table 79 in section III.K. We believe 
removing ACO-26 is consistent with our proposals to align with the PQRS 
program and remove redundancy of measures 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 
performance on the diabetes composite. We also note that the removal of 
this measure would additionally 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.
    We believe that the final measure set as adopted 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 the quality performance 
standards that ACOs must meet to be eligible for shared savings. 
Although the number of measures in the measure set remains at 33, we 
are reducing the number of measures reported 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 
initial period, the measures will be phased in to pay-for-performance 
over the course of an ACO's first agreement period with the exception 
of Depression Remission at 12 Months which will stay at pay-for-
reporting for all three performance years.
    Specifically, we are finalizing the following 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 during the agreement period):
    <bullet> Add the CAHPS: Stewardship of Patient Resources measure as 
pay-for-reporting in the first performance year of an ACO's first 
agreement period and pay-for-performance in the second and third 
performance years.
    <bullet> 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-performance in performance year three.
    <bullet> 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.
    <bullet> Replace ACO-12 Medication Reconciliation (NQF #0097) with 
``Documentation of Current Medications in the Medical Record'' (NQF 
#0419).
    <bullet> Add Diabetes: Eye Exam (NQF #0055).
    <bullet> 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 guidelines or are similar to existing measures (ACO-22, 23, 
24, 25, 29, and 32). We are not finalizing our proposal to remove ACO-
30 Ischemic Vascular Disease: Use of Aspirin or Another Antithrombotic 
and are removing ACO-26 Diabetes Mellitus: Daily Aspirin or 
Antiplatelet 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 proposed measures, but 
instead will continue to consider them for the future given the 
measurement gaps and high-cost, high-volume conditions these measures 
address for the quality performance standard as discussed in Table 79 
in section III.K:
    <bullet> Diabetes: Foot Exam (NQF #0056).
    <bullet> CAD: Antiplatelet therapy (NQF #0067).
    <bullet> CAD: Symptom management.

[[Page 67915]]

    <bullet> CAD: Beta-blocker therapy--prior Myocardial Infarction 
(MI) or LVSD (NQF #0070).

As a result, we will no longer have a CAD composite in the measure set 
and will only have 1 CAD measure in the Clinical Care in the At-Risk 
Population domain (ACO# 33: Angiotensin-Converting Enzyme (ACE) 
Inhibitor or Angiotensin Receptor Blocker (ARB) Therapy--Diabetes or 
Left Ventricular Systolic Dysfunction (LVEF<40%)).
    An overview of the changes we are finalizing is provided in Table 
81, which lists the measures that will be used to assess ACO quality 
under the Shared Savings Program starting with the 2015 performance 
year.
BILLING CODE 4120-01-P

[[Page 67916]]

[GRAPHIC] [TIFF OMITTED] TR13NO14.158


[[Page 67917]]


[GRAPHIC] [TIFF OMITTED] TR13NO14.159


[[Page 67918]]


[GRAPHIC] [TIFF OMITTED] TR13NO14.160

BILLING CODE 4120-01-C

    The current quality scoring methodology is explained in the 
regulations at Sec.  425.502 and in the preamble to the November 2011 
final

[[Page 67919]]

rule (76 FR 67895 through 67900). As a result of the additions, 
deletions, and revisions 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.):
    <bullet> Patient/Caregiver Experience of Care--8 measures
    <bullet> Care Coordination/Patient Safety--10 measures
    <bullet> Preventive Health--8 measures
    <bullet> At Risk Population--6 measures (including 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 measures that are retired/replaced.

      Table 82: Number of Measures and Total Points for Each Domain Within the Quality Performance Standard
----------------------------------------------------------------------------------------------------------------
                                          Number of
                Domain                   individual       Total measures for     Total possible   Domain weight
                                          measures         scoring purposes          points         (percent)
----------------------------------------------------------------------------------------------------------------
Patient/Caregiver Experience.........               8  8 individual survey                  16               25
                                                        module measures.
Care Coordination/Patient Safety.....              10  10 measures. Note that               22               25
                                                        the EHR measure is
                                                        double-weighted (4
                                                        points).
Preventive Health....................               8  8 measures.............              16               25
At-Risk Population...................               7  5 individual measures,               12               25
                                                        plus a 2-component
                                                        diabetes composite
                                                        measure, scored as
                                                        one..
                                      --------------------------------------------------------------------------
    Total in all Domains.............              33  32.....................              66              100
----------------------------------------------------------------------------------------------------------------


                                               Table 83: Shared Savings Program Measures Retired/Replaced
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                                                    Pay for Performance Phase In  R =
                                                                                                                         Reporting P=Performance
             Notes                     Domain           Measure title      NQF measure #/      Method of data  -----------------------------------------
                                                                           measure steward       submission      Performance   Performance   Performance
                                                                                                                   Year 1        Year 2        Year 3
--------------------------------------------------------------------------------------------------------------------------------------------------------
ACO #12 Replaced...............  Care Coordination/  Medication          NQF #97 AMA-PCPI/   GPRO Web                     R             P             P
                                  Patient Safety.     Reconciliation:     NCQA.               Interface.
                                                      Reconciliation
                                                      After Discharge
                                                      from an Inpatient
                                                      Facility.
ACO #22 Retired................  At Risk             Diabetes Composite  NQF #0729 MN        GPRO Web                     R             P             P
                                  Population--Diabe   (All or Nothing     Community           Interface.
                                  tes.                Scoring):           Measurement.
                                                      Hemoglobin A1c
                                                      Control (<8
                                                      percent).
ACO #23 Retired................  At Risk             Diabetes Composite  NQF #0729 MN        GPRO Web                     R             P             P
                                  Population--Diabe   (All or Nothing     Community           Interface.
                                  tes.                Scoring): Low       Measurement.
                                                      Density
                                                      Lipoprotein
                                                      (<100).
ACO #24 Retired--Redundant       At Risk             Diabetes Composite  NQF #0729 MN        GPRO Web                     R             P             P
 Measure.                         Population--Diabe   (All or Nothing     Community           Interface.
                                  tes.                Scoring): Blood     Measurement.
                                                      Pressure <140/90.
ACO #25 Retired--Redundant       At Risk             Diabetes Composite  NQF #0729 MN        GPRO Web                     R             P             P
 measure.                         Population--Diabe   (All or Nothing     Community           Interface.
                                  tes.                Scoring): Tobacco   Measurement.
                                                      Non Use.
ACO # 26 Retired--redundant      At Risk             Diabetes            ..................  GPRO Web                     R             P             P
 measure.                         Population--Diabe   Composite: Daily                        Interface.
                                  tes.                Aspirin or
                                                      Antiplatelet
                                                      Medication Use
                                                      for Patients with
                                                      Diabetes Mellitus
                                                      and Ischemic
                                                      Vascular Disease.

[[Page 67920]]

 
ACO #29 Retired................  At Risk             Ischemic Vascular   NQF #75 NCQA......  GPRO Web                     R             P             P
                                  Population--Ische   Disease (IVD):                          Interface.
                                  mic Vascular        Complete Lipid
                                  Disease.            Profile and LDL
                                                      Control <100 mg/
                                                      dl.
ACO #32 Retired................  At Risk             Coronary Artery     NQF #74 CMS         GPRO Web                     R             R             P
                                  Population--Coron   Disease (CAD)       (composite)/AMA-    Interface.
                                  ary Artery          Composite: All or   PCPI (individual
                                  Disease.            Nothing Scoring:    component).
                                                      Drug Therapy for
                                                      Lowering LDL-
                                                      Cholesterol.
--------------------------------------------------------------------------------------------------------------------------------------------------------

    We believe that these modifications to the quality measure set for 
the Shared Savings Program will further enhance the quality of care 
patients receive from ACO participants and ACO providers/suppliers, 
better reflect clinical practice guidelines, streamline measures 
reporting, and enhance alignment with PQRS and the EHR Incentive 
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 
performance 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 performance on measures according to the phase in 
schedule.
    Comment: Most commenters did not separately provide comments 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 related issues, especially with respect to the effective 
date for benchmarking purposes. However, a number of commenters 
disagreed with the proposal to move certain new measures to pay 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 scale health system and may be newly or not yet accredited by the 
National Quality Forum (NQF).
    Response: We are finalizing our 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 needed by CMS and ACOs to fully 
implement new measures. Therefore, each new measure will be pay-for-
reporting for its first two reporting periods in use. This additional 
time will help to ensure that ACOs have adequate time to phase in their 
own care processes and infrastructure before they are held accountable 
for performance and that CMS has adequate data to set benchmarks for 
new measures before they transition to pay for performance according to 
the phase-in schedule in Table 81. In other words, the phase-in 
schedule indicated in Table 81 applies to a measure 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 participating 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 performance under 
the phase in schedule indicated in Table 81.
    For example, assume a new measure is scheduled to phase in with 
reporting in PY1, reporting in PY2, and performance in PY3. Further 
assume that an ACO with a 2014 start date will be in its second 
performance year (PY2) when the measure becomes effective. In this 
example, according to the performance year phase-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 measure 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 period then the ACO would be responsible for performance on 
the measure in PY1 of its new agreement period, because the measure was 
scheduled to be pay-for-performance in PY3 of the previous agreement 
period. If we change the assumptions in the example to an ACO with a 
start date of 2015, under the phase-in schedule the ACO would be 
responsible for performance in PY3 which corresponds with the 2017 
reporting period, the first year in which the measure is available to 
be used for pay-for-performance. In other words, each new measure is 
pay-for-reporting until it is possible to use it as pay-for-
performance, 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 Sec.  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 reporting for the first two 
reporting periods for which reporting of the measure is required. For 
subsequent reporting periods, the quality performance standard for the 
measure

[[Page 67921]]

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 
GPRO 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 reporting via the GPRO web interface, 
we proposed to make similar modifications to ACO reporting through 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 requirements for PQRS reporting from 411 to 
248 consecutively ranked and assigned patients for each 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 the GPRO web interface would also 
apply to ACOs. We stated that we believe that a reduction 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, especially for larger ACOs. These ACOs 
can include mixed models of employed and 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 assigned 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 asked 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 agreed that a reduction in the 
sample size to 248 would continue to be statistically valid and 
reliable. As discussed in section III.K.4.a, our internal assessments 
performed for PQRS confirm this conclusion. Additionally, we clarify 
that the GPRO web interface tool will continue to contain an oversample 
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 disagree 
that the reduced sample size will not adequately represent the 
diversity of the ACO's providers and suppliers. Further, we do not have 
a mechanism that would allow us to deviate from the established 
methodology used by the GPRO web interface, and therefore cannot offer 
an option at this time for ACOs to choose to be assessed on more than 
248 patients. As noted above, the tool oversamples up to 616 patients, 
and ACOs may 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 previously established.
    In order to align with the policy being finalized for PQRS, we are 
reducing the required number of consecutively ranked patients reported 
for each measure module through the CMS web interface from 411 to 248. 
Because ACOs report using the same web interface tool used by PQRS, 
this reduction in the required sample size 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 addition 
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:
    <bullet> Gaps in measures and additional specific measures: We 
solicited comments on specific measures or measure groups that may be 
considered in future rulemaking to fill in gaps that may exist for 
assessing ACO quality performance.
    <bullet> Caregiver experience of care: We solicited comment on 
additional specific caregiver experience of care measures that might be 
considered in future rulemaking.
    <bullet> 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 admissions (ASCA) 
measures.
    <bullet> 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.
    <bullet> Utilization: We welcomed 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 were interested in having 
utilization measures included in the quality performance standard, we 
welcomed specific comments on what utilization measures would be most 
appropriate for future consideration and suggestions for how to risk 
adjust these measures.
    <bullet> Health outcomes: We welcomed suggestions as to whether and 
when it would be appropriate to include a self-reported health and 
functional status measure in the quality performance standard. We 
specifically welcomed comments on the appropriateness of

[[Page 67922]]

using a tool such the Health Outcomes Survey for health plans which 
assesses changes in the physical and mental health of individual 
beneficiaries over time. We also welcomed suggestions for alternatives 
to self-reported measures that may be considered in the future.
    <bullet> Measures for retirement: We solicited input from 
commenters on any measures that should be considered for retirement in 
future 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 were proposing changes to the 
benchmarking methodology for topped out measures.
    <bullet> Additional public health measures: In the proposed rule, 
we noted that we may propose to include an additional preventive health 
measure in the quality measure set under the Shared Savings Program in 
future rulemaking. Specifically, we indicated that we were considering 
adding ``Preventive Care and Screening: Unhealthy Alcohol Use: 
Screening and Brief Counseling'' (NQF #2152). This measure would 
reflect screening of Medicare beneficiaries covered under the existing 
Medicare benefit referred to as the ``Screening and Behavioral 
Counseling Interventions in Primary Care to Reduce Alcohol Misuse'' 
benefit. We welcomed comments on the potential addition of this measure 
and noted that we would consider any comments received in developing 
any future 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 coordination, 
medication management and adherence, preventive care/adult 
immunizations, pain, malnutrition, wounds, bladder control, outcome 
measures and cost/efficiency/utilization related measures. Some 
commenters provided suggestions for specific measures that we should 
consider in future rulemaking while other commenters provided more 
general suggestions about the types of additional measures that we 
should consider. For example, some commenters 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 Medicare beneficiaries are receiving poor 
care today; and (b) it is feasible for an ACO to make changes in care 
that would improve care in those areas using the limited resources 
available in the Shared Savings Program. Others opposed utilization 
measures, believing these types of measures are not necessary within 
the Shared Savings Program because of the inherent incentive for ACOs 
participating in the program to reduce unnecessary services and achieve 
savings. A commenter supported adding public health measures ``. . . to 
help overcome the difficulties inherent in procedure-based measures 
that 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 the 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. Some 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 subjectivity, cost of collection, and risk of 
inaccurate representation based on response rate. This commenter also 
recommended that the number of measures required to be reported should 
be realistic 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, which 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 best practices and lessons learned. Comments regarding ``topped 
out'' measures for 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 consider these suggestions further as we develop any future 
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 technology infrastructure 
needed to reform the health care system and improve health care 
quality, efficiency, and patient 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 ACO providers/suppliers may help support efforts to 
achieve improvements in patient care and quality, including reductions 
in medical errors, increased access to and availability of records and 
data, improved clinical decision support, and the convenience of 
electronic prescribing. Additionally, we believe that the potential for 
the Shared Savings Program to achieve its goals could be further 
advanced by direct EHR-based quality data reporting by ACOs and their 
ACO participants and ACO providers/suppliers. This could help reinforce 
the use of CEHRT, reduce errors in quality measure submission, and 
achieve data submission efficiencies. We believe ACOs and their 
providers should be leaders in encouraging EHR adoption and should be 
using CEHRT 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 increases 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 Incentive Program--
Stage 2 Final Rule) (77 FR 53968). Included in this final rule are the 
meaningful use and other requirements that apply for the payment 
adjustments under Medicare for covered professional services provided 
by eligible professionals 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 finalizing a proposal 
to revise the name and the specifications for the quality measure 
regarding EHR adoption to take 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

[[Page 67923]]

more accurately reflect what is being measured.
    Additionally, under a group reporting option established for the 
Medicare EHR Incentive Program (77 FR 54076 through 54078), EPs 
participating 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 individually 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 (in a form and manner specified by the ACO) in 
order for the EP to potentially qualify for the Medicare EHR Incentive 
Program. The ACO must also report the GPRO web interface measures and 
satisfy the reporting requirements under the Shared Savings Program in 
order to its EPs to satisfy the CQM reporting component of meaningful 
use for the Medicare EHR Incentive Program.
    Although these group reporting requirements were established under 
the Medicare EHR Incentive Program, the Shared Savings Program 
regulations were not amended to reflect these reporting requirements. 
Therefore, we proposed to amend the regulations governing the Shared 
Savings Program to align with the requirements 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 component of meaningful use for the Medicare EHR 
Incentive Program when the ACO reports GPRO web interface measures by 
adding new paragraph (d) to Sec.  425.506. We proposed that this new 
paragraph would 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 ACO to satisfy 
its quality reporting requirements from CEHRT; and (2) the ACO 
satisfactorily reports the ACO GPRO measures through a CMS web 
interface.
    Although we did not propose any new requirements 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 especially solicited comment on the 
feasibility of an ACO to be a convener and submitter of quality 
measures through an EHR or alternative method of electronically 
reporting quality measures to us. We indicated our interest in the 
opportunities and barriers to ACO EHR quality measure reporting, as 
well as ways to overcome any barriers. We also welcomed suggestions on 
alternative ways that we might implement EHR-based reporting of quality 
measures 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 by 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 supplement 
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 reflect any special services they 
provide. As an alternative, we also solicited comment on whether ACO 
providers/suppliers could use a local registry-like version of the GPRO 
web interface 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 decision not to propose any 
new requirements at this time regarding EHR based reporting, and they 
agree with aligning the Shared Savings Program with the EHR Incentive 
Program whereby EPs participating in an ACO can satisfy the CQM 
reporting component of meaningful use when the EP extracts data 
necessary for the ACO to satisfy its quality reporting requirements 
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 Society 
(HIMSS) considered requiring EHR-based reporting of quality measures in 
the Shared Savings Program to be premature. Commenters raised concerns 
that the current lack of interoperability capabilities for ACOs that 
are formed by disparate organizations, often hospitals and physician 
groups coming together, but using differing EHR platforms that do not 
communicate electronic data sufficiently to centralize data for quality 
reporting would limit the ability of ACOs to successfully report 
quality through an EHR. They state it will take significant resources 
and time to ensure that interoperability is achieved. Rather than 
requiring EHR-based reporting, some commenters suggested that CMS 
should give providers the option to report through EHRs.
    Response: We appreciate the comments recommending that we not 
establish any new requirements at this time regarding EHR based 
reporting under the Shared Savings Program. We also appreciate the 
comments supporting aligning 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 extracts data 
necessary for the ACO to satisfy its GPRO reporting requirement using a 
CEHRT and 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 understand and 
appreciate the feedback from those stakeholders who raised important 
concerns about the readiness of ACOs and EHR systems to report quality 
electronically under the Shared Savings Program. We will use the 
information provided by commenters to work with ACOs and other 
stakeholders 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 comments 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 the CQM reporting 
component of

[[Page 67924]]

meaningful use when the eligible professional extracts data from CEHRT 
necessary for the ACO to satisfy its quality reporting requirements 
under the Shared Savings Program and the ACO reports the GPRO measures 
through the CMS web interface. This policy will be codified at Sec.  
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 meaningful 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 order 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 satisfy the CQM reporting component of meaningful 
use for the Medicare EHR Incentive Program.
    Although this amendment to the regulations will align the Medicare 
Shared Savings Program regulations with the existing requirements 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 Act directs the Secretary to 
``establish 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 Sec.  425.502, 
the following requirements with regard to establishing a quality 
performance benchmark for measures apply: (1) During the first 
performance 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 years, the quality performance standard 
will be phased in such that ACOs will be assessed on their performance 
on certain measures (see Table 1 of the November 2011 Shared Savings 
Program final rule (76 FR 67889 through 67890), for details of the 
transition for each of the 33 measures); (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 60th percentile is 
equal to or greater than 80.00 percent.
    Section 425.502(b)(2) governs the data that CMS uses to establish 
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 participating in the Shared Savings Program over 
time, Sec.  425.500(b)(3) states that in establishing the measures 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, including data gathered under PQRS (through 
both the GPRO web interface tool and other quality reporting 
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 
was appropriate to use all FFS data rather than only ACO data, at least 
in the early years of the program, to avoid the possibility of 
punishing high performers where performance is generally high among all 
ACOs. We did not finalize a proposal to use Medicare Advantage (MA) 
data alone or in combination with FFS data in the 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 setting benchmarks for 
ACOs.
    Additionally, in the CY 2014 PFS final rule with comment period, we 
retained the ability to use flat percentages to set benchmarks when 
many reporters demonstrate high achievement on a measure, so that ACOs 
with high performance on a measure are not penalized (78 FR 74760). 
More specifically, we will now use all available FFS data to calculate 
benchmarks, including ACO data, except where performance at the 60th 
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 high scores to 
earn maximum or near maximum quality points while still allowing room 
for improvement and rewarding that improvement in subsequent years.
    As previously discussed, the first performance 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 achieve to 
earn the maximum quality points under each domain. In the November 2011 
Shared Savings Program final rule, we indicated our intent to gradually 
raise the minimum attainment level to continue to incentivize quality 
improvement over time and noted that we would do so through future 
rulemaking after providing sufficient advance notice with a comment 
period to allow for industry input (76 FR 67898). In the CY 2014 PFS 
final rule with comment period, we reiterated our policy of setting 
quality performance benchmarks prior to the reporting year for which 
they would apply (78 FR 74759). Specifically, we use data submitted in 
2013 for the 2012 reporting period to set the quality 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 rewarded 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 advance using data submitted during 2013 
for the 2012 reporting year, and continue to use that benchmark for 2 
reporting years (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 appropriate number of 
years that a benchmark should apply before it is updated.

[[Page 67925]]

b. Revisions for Benchmarking Measures 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 ACOs 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 smaller and medium size physician practices to achieve 
higher levels of performance 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 is possible that smaller practices 
or practices with smaller populations may be able to achieve these 
higher levels of performance more easily than larger practices or 
organizations with larger patient populations. Therefore, we proposed 
certain modifications to our benchmarking methodology to address the 
way that such ``topped 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 
equal to 95 percent, we would use flat percentages for the measure, 
similar to our policy under Sec.  425.502(b)(2)(ii) of using flat 
percentages when the 60th percentile is greater than 80 percent to 
address clustered measures. We believe this approach would address 
concerns about how topped out measures affect the quality performance 
standard while continuing to reward high performance, and being readily 
understandable to all. We proposed to revise Sec.  425.502(b)(2)(ii) to 
reflect this policy. We invited comments on this proposal. We also 
invited comments on other potential approaches for addressing topped 
out measures. We indicated that we would use any 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 percentile 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 rulemaking. Many 
commenters supported retaining such measures with the view that quality 
measures are intended to protect Medicare beneficiaries from receiving 
inappropriate care. If all but a few organizations achieve near perfect 
performance, the commenters believe it would be important to retain 
that measure to encourage better performance from the low performing 
organizations, and to prevent backsliding by the high performers. Other 
commenters, including MedPAC, suggested removing topped out measures to 
reduce reporting burden. Others suggested that topped out measures 
could be dropped or moved from being process-based to clinical outcome-
based and be folded into composites to prevent ``back sliding,'' or 
that they could be considered ``deemed met'' without a reporting 
requirement but available for audit if so chosen.
    Response: We appreciate the commenters' support for the proposal to 
use flat percentages when the national FFS data results in the 90th 
percentile performing at greater than or equal to 95 percent. We also 
appreciate the additional suggestions regarding treatment of topped out 
measures and intend to consider this issue further in future 
rulemaking.
    Final Decision: After consideration of the comments received on 
this issue, we are finalizing our proposal to use flat percentages when 
the national FFS data results in the 90th percentile for a measure are 
greater than or equal to 95 percent. We are also finalizing our 
proposed revisions to Sec.  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 60th percentile is equal 
to or greater than 80.00 percent, we clarify that this methodology 
would apply to all measures, including measures whose performance rates 
are calculated as ratios, for example, measures such as the ACO 
Ambulatory 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 
performance rates are calculated as ratios. Measures calculated and 
reported as ratios may also become topped out and we believe it is 
important to keep a consistent approach for addressing all Shared 
Savings Program measures that become topped out.
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 during 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 standard 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 ACO were to subsequently enter into a second or 
subsequent participation agreement. However, Sec.  425.502(a)(1) 
provides that during the first performance year of an ACO's agreement 
period, CMS will define the quality performance standard at the level 
of complete and accurate reporting of all quality measures. As drafted, 
this regulation could be read to imply 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 appropriate for an ACO in a second 
or subsequent agreement period to report quality measures on a pay-for-
reporting basis if they have previously reported these measures in a 
prior agreement period. The ACO would have gained experience reporting 
the quality measures during the earlier agreement period, and as a 
result, we do not believe it would be necessary to provide any further 
transition period. Rather, we believe it would be appropriate to assess 
the ACO's actual performance on measures that have been designated as 
pay for performance during all 3 years of the second or subsequent 
participation agreement period.
    Accordingly, we proposed to revise our regulations to expressly 
provide that during a second or subsequent participation agreement 
period, the ACO would continue to be assessed on its performance on 
each measure that has been designated as pay for performance. That is, 
the ACO would continue to be assessed on the quality performance 
standard that would otherwise apply to an ACO if it were in the third 
performance year of the first agreement period. We will do this by 
modifying Sec.  425.502(a)(1) and (a)(2) to

[[Page 67926]]

indicate that the performance standard will be set at the level of 
complete and accurate reporting of all quality measures only for the 
first performance year of an ACO's first agreement period, and that 
during subsequent agreement periods, pay for performance will apply for 
all three performance years.
    Comment: We received relatively few comments on this proposal. A 
number of those that responded supported the proposal. A few were 
hesitant to support it, suggesting that a performance standard for a 
quality measure should not be continued into a second or a subsequent 
participation agreement period if there 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 these 
commenters raised is if an ACO with a 2013 start date (three year 
agreement for 2013 through 2015) chooses to sign a subsequent three 
year agreement (for 2016 through 2018), that requires it to accept 
risk, then the ACO would possibly be facing new benchmarks beginning in 
PY 2016 and would not be afforded a one year pay for reporting 
transition period to gain experience with the new benchmarks.
    Response: We appreciate the comments in support of this proposal. 
We believe that concerns that were expressed by some commenters about 
changes in the measure set are addressed through the phase-in schedule 
for new 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 
benchmarking and publish benchmarks prior to the start of the third 
reporting period in which a new measure is in use. This two year grace 
period will also permit ACOs to become accustomed to the measure 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 period 
(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 subsequent 
agreement period. Because the ACO would be in its subsequent agreement 
period, all measures would be pay-for-performance at that time, with 
the exception of measures that remain pay-for-reporting in all years, 
according to the phase-in schedule indicated in Table 81. For example, 
the Depression Remission at 12 Months measure (ACO# 40) is pay-for-
reporting for all three years of an ACO's first agreement period. In a 
subsequent agreement period, ACOs will continue to be assessed on this 
measure as pay-for-reporting, which corresponds to the level of 
performance required in PY3 of the first agreement period.
    Final Decision: We are finalizing our proposal to modify Sec.  
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-
reporting 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 measures, 
which are designated as pay-for-reporting during the first two 
reporting periods they are in use.
d. Timing for Updating Benchmarks
    As discussed in the CY 2014 PFS final rule with comment (78 FR 
74761), we have further considered suggestions from ACOs regarding the 
appropriate number of years that a benchmark should apply before it is 
updated. ACOs suggested that there 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 
quality 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 combination of all 
available Medicare FFS quality data, including data gathered under 
PQRS, the Shared Savings Program and Pioneer ACO Model, but not MA 
quality data. To the extent that the benchmarks are based on quality 
data reported by a large number of ACOs and other FFS entities, we 
believe 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 are also persuaded that we should 
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 
setting benchmarks every 2 years to setting benchmarks every 5 years. 
For example, we considered the option of setting benchmarks every 3 
years. However, we note that ACO agreement periods are 3 years long and 
a new cohort of ACOs enters the program each year. As a result, setting 
benchmarks every 3 years might advantage some ACOs over others, 
particularly ACOs that have 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 amount 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 enable us to be more 
flexible and give us the ability to make adjustments more frequently if 
appropriate. We note, however, that we may revisit this 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 Sec.  425.502(b) to add a new 
paragraph (b)(4)(i), which would provide that CMS will update 
benchmarks every 2 years. To illustrate this proposed policy, the 
existing quality performance benchmarks, which are based on data 
submitted in 2013 for the 2012 reporting period would apply for a total 
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 during 2015. These updated 
benchmarks would apply for the 2016 and 2017

[[Page 67927]]

performance years. This timeline 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 revise Sec.  425.502(b) to add a new paragraph (b)(4)(ii), 
which would provide that for measures introduced in the first year 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 next 2-year benchmarking cycle.
    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 between years. For 
instance, the age range used for the breast cancer screening measure is 
different in 2014 than in 2013, or when the measure owner modifies or 
retires a measure. Additionally, 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 reporting periods should also be considered in 
establishing benchmarks that will apply for 2 performance 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 comments in response to this 
proposal. In general most commenters supported setting benchmarks for 
at least two years but many, including some ACOs, supported a longer 
period of at least three years to align with the Shared Savings Program 
agreement period to provide more stability for ACOs. There were some 
commenters that suggested more frequent adjustment of benchmarks under 
certain situations, suggesting that more frequent benchmark updates may 
be necessary whenever there are substantive specification changes for a 
measure, such 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 
benchmark and that CMS must therefore consider establishing new 
benchmarks when even ``non-substantive'' changes are made to measure. A 
commenter suggested that instead of the proposed two year interval, 
benchmarks should be adjusted annually if there is a statistically 
significant performance change across all organizations. Some 
commenters suggested the use of multiple years of data to set 
benchmarks, suggesting, for example, that some measures could be 
susceptible to year specific events that could skew results.
    Response: We are finalizing our 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 improvement 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 reasonably current practices, if 
the data 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 benchmarks for two years to 
provide ACOs with stable targets for quality improvement. In addition, 
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 
finalizing our proposal to revise Sec.  425.502(b) to add a new 
paragraph (b)(4)(i) providing that 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 two reporting periods for which the measure is 
in use, we are revising proposed Sec.  425.502(b)(4)(ii) to provide 
that for newly introduced measures that transition to pay for 
performance in the second year of the 2-year benchmarking cycle, the 
benchmark will be established in that year and updated along with the 
other measures at the start of the next 2-year benchmarking cycle. For 
example, if a new measure is scheduled to become pay for performance in 
2017 after being used for 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 biennial benchmarking schedule outlined in 
Table 84.

                   Table 84--Timeline for Setting and Updating Quality Performance Benchmarks
----------------------------------------------------------------------------------------------------------------
                                                                 Year data is analyzed,    Performance year and
        Reporting period for data used to set benchmark             and benchmark is       reporting period to
                                                                       published         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 performance standard in 
order to be eligible to share in savings. The Shared Savings Program 
quality performance standard currently consists of a set of quality 
measures spanning four domains that are collected 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 coordination/patient safety, preventive 
health, and at-risk populations. The measures collected

[[Page 67928]]

through the CMS web interface are also used to determine whether 
eligible professionals that bill through the TIN of an ACO participant 
qualify for the PQRS incentive payment or avoid the downward 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.
    Under current policy, the quality performance standard 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 performance 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 higher performance translates to higher shared savings. For 
example, an ACO that performs at the 80th percentile one year and then 
at the 90th percentile the next year would receive a higher level of 
shared savings 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 earlier 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) 
hospitals are scored based on the higher of their achievement or 
improvement on specified quality measures, with some hospitals 
receiving incentive payments if their overall performance is high 
enough 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 incorporates a sliding 
scale in which higher levels of quality performance translate to higher 
sharing rates. We believed that high performing ACOs should do well 
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.
b. Additional Rewards for Quality Improvement
    ACOs and other stakeholders have suggested 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 that improve from one year to 
the next.
    As discussed previously, the existing quality performance standard 
includes a sliding point scale that rewards ACOs for 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 stakeholders that an additional, more explicit reward 
should be included for ACOs that improve their quality scores from year 
to year. Therefore, we proposed to revise our existing quality scoring 
strategy to explicitly recognize and reward ACOs that make year-to-year 
improvements in their quality performance scores on individual 
measures.
    To develop such an approach, we looked 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 
improvement change score which is defined as the score for a measure in 
a performance year minus the score in the previous performance year. 
The MA five star rating program then measures each plan's net quality 
improvement by calculating the total number of significantly improved 
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 
measure, see the discussion in ``Medicare 2014 Part C & D Star Rating 
Technical Notes'', Attachment I, page 80, which can be downloaded from 
the CMS Web site at http://www.cms.gov/Medicare/Prescription-Drug-Coverage/PrescriptionDrugCovGenIn/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 requirements. 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 developed 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 vetted 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 
would minimize disruption for ACOs. We believe it would be undesirable 
for both ACOs and the program if the quality improvement measure were 
added in a way that required extensive revisions 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 additional bonus points for 
quality performance improvement on the quality measures within the 
domain. These bonus points would be added to the total points that the 
ACO achieved within each of the four domains. Under this proposal, the 
total possible points that could be achieved in a domain, including up 
to 2 bonus points, could not exceed the current maximum total points 
achievable within the domain.
    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, the current methodology for calculating the ACO's overall 
quality performance score would continue to apply (see Sec.  425.502(e) 
and 76 FR 67895 through 67900). Additional details about the proposal 
to incorporate bonus points into the quality performance scoring 
methodology are discussed in the CY 2015 Physician Fee Schedule 
proposed rule (79 FR 40490 through 40492). Highlights of the 
methodology we proposed are as follows:
    The quality improvement measure scoring for a domain would be based 
on

[[Page 67929]]

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 example, new measures, would not be included in the 
assessment of improvement. Otherwise, for purposes of determining 
quality improvement and awarding bonus points, we would include all of 
the individual measures within the domain, including both pay-for-
reporting measures and pay-for-performance measures. In determining 
improvement, the actual performance score achieved by the ACO on the 
measure would be used, not the score used to determine shared savings. 
In other words, we would calculate a 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 agreement 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 the ACO for informational 
purposes. We believe it is appropriate to use these actual performance 
scores to assess improvement on a measure from year to year, regardless 
of whether the measure is designated as a pay for 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 performance by the ACO.
    If the ACO is in its first performance year of its first agreement 
period, then it would not be possible, of course, to measure quality 
improvement. Therefore, for these ACOs the existing scoring methodology 
would continue to apply and 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 
renews 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 performance 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 Rating Technical Notes'', Attachment I, page 80, 
which can be downloaded from the CMS Web site at http://www.cms.gov/Medicare/Prescription-Drug-Coverage/PrescriptionDrugCovGenIn/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 the same. The 
test recognizes and appropriately adjusts measures at both high and low 
levels of performance for statistically significant levels of change. 
Under this methodology, we can be reasonably certain, at a 95 percent 
level of confidence, that statistically significant 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 based on an ACO's net 
improvement within a domain, and would be calculated by determining 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 sliding 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 methodology, 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 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 amount of shared savings or, if applicable the amount of 
losses it owes, consistent with the requirements under Sec.  
425.502(e).
    In developing this proposal to award bonus points for quality 
improvement, we considered several alternative options. Specifically, 
we considered whether it would be more appropriate not to award bonus 
points but instead to include a computed quality improvement measure 
that would be incorporated into the current scoring methodology just as 
any other measure would be added. Under this alternative approach, we 
would increase the total possible points that could be awarded in a 
domain. However, we did not propose that approach because we believe 
that awarding bonus points would provide the desired incentive, would 
be more understandable and less disruptive, and would not require 
extensive changes to the quality performance standard. By awarding 
bonus points we also avoid the 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 ACOs 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 
incremental improvement at higher levels of performance and does not 
impose any penalty on ACOs that have already achieved a high level of 
performance.
    We also considered whether we should provide 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. However, 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 whether it would be 
appropriate to use the ``pay for reporting'' data reported to us, given 
that this information does not affect an ACO's quality performance 
score in the first

[[Page 67930]]

performance year. Therefore, we considered whether the quality 
improvement score should apply only to those ACOs that have completed 
at least two performance years. Under this alternative approach, ACOs 
would have an opportunity to be assessed based on their actual quality 
measure performance before being assessed on their quality improvement 
scores. We did not select this 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 appropriate to 
include pay-for-reporting measures for purposes of awarding bonus 
points since under Sec.  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 Sec.  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 discussed in the proposed rule. We also 
solicited comments on whether there are other alternative approaches to 
explicitly rewarding quality improvement for ACOs, and whether the 
implicit reward for quality improvement 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 methodologies 
such as those employed by HVBP or MA. Such comments would be considered 
in developing possible future proposals to further align with other 
Medicare quality improvement programs.
    Comment: Commenters were supportive of explicitly 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 improvement 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 the proposal to award up to two bonus points would 
increase the overall quality performance score for an ACO by at most 14 
percent. Some commenters suggested additional approaches, such as 
awarding an additional 10 percent of shared savings for those ACOs that 
score in the top 10 percent on quality measures. Another example is a 
suggestion that ACOs be allowed to retain 50% of their share of savings 
regardless of the MSR if their overall quality score improves year-
over-year.
    Response: We appreciate the overall support from commenters who 
generally agreed with the proposal to offer an additional and explicit 
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 explicit incentive places even greater emphasis on quality 
improvement, encouraging all ACOs to continue 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 maintaining 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 appear 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 approximately 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 of adoption of EHR meaningful use. 
Permitting the quality improvement measure to be double weighted would 
similarly emphasize the importance of quality improvement, further 
encouraging ACOs to improve overall quality for their patient 
populations over time.
    Final Decision: We are finalizing our proposal to provide an 
additional quality improvement reward for Shared Savings Program ACOs 
who demonstrate quality improvement on measures in a domain. We believe 
that this 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 points that the ACO achieves within each of the four 
domains. The total possible points that can be achieved in a domain, 
including up to 4 bonus points, could not exceed the maximum total 
points achievable within the domain. For example, as shown in Table 82, 
the total possible 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 provide 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 then the ACO's total 
points for this domain would be 16. However, if instead this same ACO 
had scored 13 points, then this ACO's total points after adding the 
bonus points would still not exceed 16. Table 82, which shows the 
number of points available per domain under the revised quality 
performance 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 
possible points for the domain, 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 
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 Sec.  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 
applying a ``t-test'' which is a common standard statistical test, at a 
95 percent

[[Page 67931]]

level of confidence. (See the discussion of the t-test 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 Web site at http://www.cms.gov/Medicare/Prescription-Drug-Coverage/PrescriptionDrugCovGenIn/PerformanceData.html). This test assesses how unlikely it is that 
differences as big as those observed would be due to chance when the 
performance is actually the same.
    The bonus points, up to a maximum of 4 points, will be awarded in 
direct proportion to the ACO's net improvement for the domain to the 
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 quality 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 and 
no significant quality decline on any of the measures 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 still 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 Sec.  425.502(e) to incorporate the new bonus points 
scoring methodology, but are revising the proposed language in order to 
reflect our decision to award up to 4 bonus points per domain.
7. Technical Corrections
    Currently Sec.  425.502(d)(2)(ii) states that ACOs must score above 
the minimum attainment level determined by CMS on 70 percent of the 
measures in each domain. If an ACO fails to achieve the minimum 
attainment level on at least 70 percent of the measures in a domain, 
CMS will take the actions described in Sec.  425.216(c). We note that 
Sec.  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 encompass all of the actions we may take prior to 
termination, we believe the correct reference should be to Sec.  
425.216 generally, and therefore, proposed to make a technical 
correction to Sec.  425.502(d)(2)(ii) to eliminate the specific 
reference to paragraph (c) of Sec.  425.216. We also proposed to 
correct a typographical error in this provision by revising ``actions 
describe'' to read ``actions described.''
    In addition, we also proposed to make a technical correction to 
Sec.  425.502(a)(2). This provision currently states that ACOs will be 
assessed on performance based on the minimum attainment level for 
certain measures. However, 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 minimum 
attainment level for the measure but also based upon the quality 
performance benchmark that has been established for that measure. This 
methodology for calculating the performance score for a measure is 
codified in the regulations at Sec.  425.502(c). Accordingly, we 
proposed to amend Sec.  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 technical corrections.
    We received no objections to correcting the typographical errors 
and making these other minor technical corrections and are finalizing 
them as proposed.

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 physicians and groups of 
physicians 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 eligible 
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 transparency of 
health care quality information and to assist providers and 
beneficiaries in improving medical decision-making and health care 
delivery.\13\
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    \13\ Kate Goodrich, et al. ``A History and a Vision for 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.
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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 specific principles should 
govern the implementation of the VM (77 FR 69307). We refer readers to 
that rule for a detailed discussion and list those principles here for 
reference.
    <bullet> A focus on measurement and alignment. Measures for the VM 
should consistently reflect differences in performance among groups or 
solo practitioners, reflect the diversity of services furnished, and be 
consistent with the National and CMS Quality Strategies and other CMS 
quality initiatives, including the PQRS, the Shared Savings Program, 
and the Medicare EHR Incentive Program.
    <bullet> A focus on physician and eligible professional choice. 
Physicians and other nonphysician eligible professionals should be able 
to choose the level (individual 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.
    <bullet> A focus on shared accountability. The VM can facilitate 
shared accountability by assessing performance at the group level and 
by focusing on the total costs of care, not just the costs of care 
furnished by an individual professional.
    <bullet> A focus on actionable information. The Quality and 
Resource Use Reports (QRURs) should provide meaningful and actionable 
information to help groups and solo practitioners identify clinical, 
efficiency and effectiveness areas where they are doing well, as well 
as areas in which performance could be improved by providing groups and 
solo practitioners with QRURs on the quality and cost of care they 
furnish to their patients.
    <bullet> A focus on a gradual implementation. The VM should focus 
initially on identifying high and low performing groups and solo 
practitioners. As we gain more experience with physician measurement 
tools and methodologies, we can broaden the scope of measures assessed, 
refine physician peer groups, create finer 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 professionals. A summary of the

[[Page 67932]]

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 (78 FR 
74765 through 74787), we finalized policies to continue the phase-in of 
the VM by applying it starting January 1, 2016 to payments under the 
Medicare PFS for physicians in groups of 10 or more eligible 
professionals.
4. Provisions of This Final Rule With Comment Period
    As a general summary, we proposed the following VM policies in the 
CY 2015 PFS proposed rule:
    <bullet> To apply the VM to all physicians and nonphysician 
eligible professionals in groups with two or more eligible 
professionals and to solo practitioners starting in CY 2017.
    <bullet> To make quality-tiering mandatory for groups and solo 
practitioners within Category 1 for the CY 2017 VM. Where solo 
practitioners and groups with two to nine eligible professionals would 
be subject only to any upward or neutral adjustment determined under 
the quality-tiering methodology.
    <bullet> To tailor the application of the VM to physicians and 
nonphysician eligible professionals participating in the Medicare 
Shared Savings Program (Shared Savings Program), the Pioneer ACO Model, 
the CPC Initiative, or other similar Innovation Center models or CMS 
initiatives starting in CY 2017.
    <bullet> To clarify the exclusion of non-assigned claims for non-
participating providers from the VM.
    <bullet> 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.
    <bullet> To align the quality measures and quality reporting 
mechanisms for the VM with those available to groups and individuals 
under the PQRS during the CY 2015 performance period.
    <bullet> To expand the current informal inquiry process to allow 
additional corrections for the CY 2015 payment adjustment period.
    <bullet> To address the concerns raised by NQF regarding the per 
capita 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, and 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) Risk Adjustment methodology used in the total per 
capita cost measures for the VM does not accurately capture the 
additional costs associated with treating the sickest beneficiaries. 
Some of these commenters stated that groups that work exclusively in 
post-acute and long-term care settings would be unable to perform well 
on cost measures under the current methodology. Commenters 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 other groups that treat beneficiaries 
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 beneficiaries in this 
location. One 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 beneficiaries 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 
than a certain number of chronic conditions or activities of daily 
living dependencies, change the risk adjustment methodology to include 
the frailty adjuster used in the PACE program, or add ``recognition of 
savings from expected costs.''
    Response: We appreciate the concerns raised by commenters and agree 
that it is important to make adjustments for differences in beneficiary 
characteristics 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 include adjustments for Medicare 
and Medicaid eligibility status in addition to diagnoses, and 
truncating costs at the 99th percentile for the highest cost 
beneficiaries, help address these concerns. While, the VM program does 
not, in the aggregate, adjust costs using an institutional risk 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 pertained 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 that might 
routinely treat more complex and consequently more costly 
beneficiaries, we finalized in the CY 2013 PFS final rule with comment 
period that we would apply a specialty adjustment to all cost measures 
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 methodology is 
effective at predicting actual costs, even for beneficiaries with 
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 simply 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 
care: The critical role of quality measurement. Healthcare. 2014. 
2,53-62.
---------------------------------------------------------------------------

    We note that high costs within the post-acute and long-term care 
settings present a unique opportunity for these providers to improve 
performance on cost and quality measures. While we continue to 
encourage providers to report quality measures for patients in these 
settings and to use the information contained in their QRUR to improve 
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, section 1848(p)(4)(B)(iii)(II) of the 
Act requires the Secretary to apply the VM to items and services 
furnished 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 payment 
adjustment period to physicians in groups of physicians with two or 
more eligible professionals and to physicians 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 ``solo practitioner'' at Sec.  414.1205 as a 
single Tax Identification Number (TIN) with one eligible professional 
who is identified by an individual National

[[Page 67933]]

Provider Identifier (NPI) billing under that TIN. We noted that this 
proposal to apply the VM to all solo practitioner 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 eligible professionals 
and to solo practitioners (79 FR 40494). We noted that we conducted 
statistical reliability analysis on the PQRS quality measures and the 
VM cost measures reported in the 2010 and 2011 group and individual 
Quality and Resource Use Reports (QRURs) (78 FR 43500 through 43502) 
and found that 98 percent of the PQRS measures included in the 
analysis, which were substantially 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 results suggest that we can reliably apply these measures to 
solo practitioners and groups (79 FR 40494). In section III.N.4.h, we 
discuss the reliability of the all-cause readmission measure and the 
policy we are finalizing to address reliability concerns regarding that 
measure.
    In Table 55 of the proposed rule, we presented 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 
identified by their TINs). We further estimated that the groups consist 
of approximately 815,000 physicians and 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 claim 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, such 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 professionals and to all physicians who are 
solo practitioners in CY 2017 would affect approximately 900,000 
physicians.

                                     TABLE 86--Eligible Professional/Physician Group Size Distribution (2013 claims)
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                             Eligible                        Number of                      Percent of
                       Group size                            Number of     professionals     Number of     nonphysician     Percent of     nonphysician
                                                          groups (TINs)*       (EPs)        physicians          EPs         physicians          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
  Comprehensive 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 proposal 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 quality-tiering methodology (78 FR 74780 through 74781). However, 
we noted this policy was codified in Sec.  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 Sec.  
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 Sec.  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 
Sec.  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 
solo 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 Sec.  414.1270 accordingly.
    We proposed to revise Sec.  414.1210 to reflect that beginning in 
the CY 2017 payment adjustment period, the VM would be applied 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 Sec.  414.1215 (79 FR 40495). 
Accordingly, we proposed to amend the regulations under subpart N to 
add references to solo practitioners. We solicited comments on all of 
these proposals.
    The following is summary of the comments we received on these 
proposals.
    Comment: We received one comment that supported our proposed 
definition of a ``solo practitioner.''
    Response: We appreciate this comment and are finalizing the 
definition of a ``solo practitioner'' to mean, ``a single Taxpayer 
Identification Number (TIN) with one eligible professional who is 
identified by an individual National Provider Identifier (NPI) billing 
under the TIN.'' We are codifying this definition at Sec.  414.1205.
    Comment: Several commenters expressed concern that the cost 
measures potentially have little relevance to some provider groups and 
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 beneficiaries being attributed to the group.
    Response: As we stated in the CY 2014 PFS final rule with comment

[[Page 67934]]

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 the calculation of reliable cost measures. We are 
concerned that not classifying the group as ``average'' when it has 
fewer than 20 attributed beneficiaries for at least one cost measure 
would increase the likelihood 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 practitioner will 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 and codifying the 
policy as proposed in Sec.  414.1270. We are also finalizing our 
proposal 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) for groups of physicians should be the same as the regulation 
text at Sec.  414.1270(b)(5).
    Comment: Several commenters, citing the Secretary's statutory 
obligation, supported our proposal to apply the VM in the CY 2017 
payment adjustment year to solo practitioner physicians and to groups 
of physicians with two or more eligible professionals. Other commenters 
opposed our proposed policy notwithstanding the statutory obligation to 
apply the VM to all physicians and groups of physicians beginning not 
later than January 1, 2017. Commenters stated that we should delay the 
application of the 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 
access to adequate technical support, and potential lack of 
understanding of the information provided through the Physician 
Feedback Program, we should postpone the extension of the VM to smaller 
group practices and solo practitioners. Some commenters suggested that 
the VM would negatively impact physicians, especially given the 
proposed increase in the amount of payment at risk for CY 2017.
    Response: We disagree that the VM's application to smaller groups 
and solo practitioners should be delayed. In addition to the statutory 
requirement to apply the VM to all physicians and groups of physicians 
beginning not later than January 1, 2017, the application of the VM to 
all physician groups and solo practitioners is essential to our ongoing 
efforts to encourage improvement in the quality and efficiency of care 
provided to Medicare beneficiaries and should not be delayed. The 
literature highlights that the majority of patients 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-enabled 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 smaller group practices and solo practitioners 
has the potential to incentivize increased participation in quality 
reporting and quality improvement activities and that smaller groups 
and solo practitioners have the potential to perform well under the VM.
---------------------------------------------------------------------------

    \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 Quality of Care in Small Practices With Electronic 
Health Records. J. Amer. Med. Ass'n. 2013. 310,1051-1059.
---------------------------------------------------------------------------

    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 smaller downward payment adjustment 
under the VM for these groups and solo practitioners that are in 
Category 2 in CY 2017 (as discussed in section III.N.4.f below). Please 
note that in section III.N.4.b of this final rule with comment period, 
we are finalizing that the VM will apply to nonphysician eligible 
professionals in groups subject to the VM and to nonphysician eligible 
professionals who are solo practitioners beginning in the CY 2018 
payment adjustment period.
    Comment: Several commenters stated that CMS should ensure that the 
quality and cost measures are reliable and valid for small practices 
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 appropriate to each specific provider category that reflects 
the level of care and the most important areas of service and measures 
for that provider (77 FR 69306). Analysis of the Physician Feedback 
Program confirms that the measures on which the VM is based 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 measures selected, and reported on, by the groups 
(or the eligible professionals in the groups) and the solo 
practitioners, 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 measures under the 
PQRS. This also allows these groups and solo practitioners the 
opportunity to choose measures that are relevant to their patient 
populations and consistent with clinical practice and high quality 
care. Moreover, our policy will mitigate any unintended consequences of 
the VM payment adjustment on smaller groups by holding harmless solo 
practitioner physicians and physicians in groups with two to nine 
eligible professionals from any downward payment adjustments under 
quality-tiering in CY 2017 (see section III.N.4.c of this final rule 
with comment period).
---------------------------------------------------------------------------

    \19\ Mathematica Policy Research, Experience Report for the 
Performance Year 2012 Quality and Resource Use Reports (January 8, 
2014), available at http://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/PhysicianFeedbackProgram/Downloads/2012-QRUR_Experience_Report.pdf.
---------------------------------------------------------------------------

    We conducted an additional analysis of the cost measures for the 
VM, using our specialty benchmarking methodology and found the per 
capita cost measures to be reliable for solo practitioners and groups 
of two or more eligible professionals. That analysis may be found at: 
https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/PhysicianFeedbackProgram/ValueBasedPaymentModifier.html.
    Comment: Some commenters expressed concern about the VM's impact on 
providers who treat high-cost patients and on certain specialties, such 
as anesthesiology, for which few quality measures are available.
    Response: The VM program continues to believe in the importance of 
stakeholder engagement for establishing quality metrics. To that end, 
we engage the National Quality Forum to pursue national endorsement of 
measures used in PQRS and the VM program. We are committed to using 
PQRS as the foundation for measurement 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

[[Page 67935]]

VM program that the PQRS may not provide specialists and sub-
specialists the flexibility to report on measures that 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 specialists. 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, registries, 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 report data on measures of broad applicability (77 FR 69315). The 
claims-based outcome measures used in the VM afford groups and solo 
practitioners an additional opportunity to earn a quality composite 
score that is above average. Where a group or solo practitioner falls 
in Category 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 practitioner's quality composite score would be based on the three 
claims-based outcome measures described at Sec.  414.1230, provided 
that the group or solo practitioner has at least 20 cases for at least 
one of the 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 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-Patient-Assessment-Instruments/PQRS/Downloads/2014_PQRS_Claims_MeasureApplicabilityValidation_12132013.zip. Also, 
please refer to section III.K.2 of this final rule with comment period 
for the final 2017 policies for MAV and the criteria for satisfactory 
reporting for the 2017 PQRS payment adjustment.
    Comment: Commenters cited that solo practitioners 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 
prepare for the CY 2015 performance period.
    Response: On September 30, 2014, we made Quality and Resource Use 
Reports (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 provided small groups and solo practitioners sufficient time to 
understand how the VM works and how to participate in the PQRS. We are 
sensitive to groups and solo practitioners who may need adequate lead 
time to understand 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 and groups of 2 to 25 EPs, available research 
suggested that the information provided in the QRURs is relevant to 
solo practitioners and groups for future quality improvement efforts. 
Published literature suggests that, of the beneficiaries assigned in 
one year to a group practice under the Shared Savings Program 
attribution rule, which is substantially similar to the one used in the 
VM program--80 percent were assigned to that same group practice the 
following year.\20\ In response to commenters' concerns, we also 
conducted an additional analysis using the VM attribution 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.
---------------------------------------------------------------------------

    \20\ J. Michael McWilliams, et al. Outpatient Care Patterns and 
Organizational Accountability in Medicare. 2014. 174,938-945.
---------------------------------------------------------------------------

    More importantly, we believe our final policy to hold harmless 
groups with two to nine eligible professionals and solo practitioners 
from any downward payment adjustments under quality-tiering in CY 2017 
would likely mitigate unintended consequences that could occur (see 
section III.N.4.c of this final rule). We note 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 eligible professionals subject to the VM in CY 
2015, including findings based on the data contained in the 2013 QRURs 
for all groups of physicians and solo practitioners.
    Comment: Several commenters believed that physicians had have 
little experience with the PQRS program and physicians generally do not 
understand the methodology used to calculate the VM and therefore urged 
CMS to increase 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 measures 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 methodology 
used to calculate the VM, we strongly encourage physicians to 
proactively educate themselves about the PQRS and VM programs by 
visiting the PQRS Web site http://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/PQRS/index.html and VM/QRUR 
Web site http://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/PhysicianFeedbackProgram/index.html. The PQRS Web site contains 
detailed information about how groups and individual eligible 
professionals can participate in the PQRS program, including 
information on how to avoid the PQRS payment adjustment. The VM/QRUR 
Web site (https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/PhysicianFeedbackProgram/index.html) contains 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 note that we work with medical and specialty 
associations throughout the year to educate them about the PQRS and VM 
programs and the QRURs. Further outreach will be also be undertaken by 
our Quality Improvement Organizations (QIOs), who will provide 
technical assistance to physicians and groups of physicians in an 
effort to help them improve quality and consequently, 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 
characteristic of those groups of physicians and solo practitioners 
that could be subject to an upward or downward payment adjustment under 
our quality-tiering

[[Page 67936]]

methodology to determine 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 are finalizing the 
proposal and regulation text at Sec.  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 professionals and to 
physicians who are solo practitioners based on the performance period 
described at Sec.  414.1215. We are finalizing the definition of a 
``solo practitioner'' at Sec.  414.1205 and amending the regulations 
under subpart N to add references to solo practitioners. We are also 
finalizing our proposal and the regulation text at Sec.  414.1270(c)(5) 
that beginning in CY 2017 a group or solo practitioner will 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 are also 
finalizing our proposal 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) for groups of physicians should be the same as 
the regulation text at Sec.  414.1270(b)(5).
b. Application of the VM to Nonphysician EPs
    As noted above, section 1848(p) of the Act requires that we 
establish the VM and apply it to items and services furnished under the 
PFS beginning on January 1, 2015, for specific physicians and groups of 
physicians the Secretary determines appropriate, and beginning not 
later than January 1, 2017, for all 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 eligible 
professionals as defined in section 1848(k)(3)(B) of the Act. As 
previously finalized in the CY 2013 PFS final rule with comment period, 
in payment adjustment years CY 2015 and CY 2016, we will apply the VM 
to Medicare payments for items and services billed under the PFS by 
physicians in groups (as identified by their Medicare-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 
medicine, doctors of podiatric medicine, 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 groups of physicians with two or more eligible 
professionals and to physicians who are solo practitioners as required 
by section 1848(p)(4)(B)(iii)(II) of the Act.
    In the CY 2015 PFS proposed rule, based on the Secretary's 
discretion 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 who 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 eligible professionals who bill under a 
group's TIN. We proposed to apply the VM beginning in CY 2017 to groups 
that consist only of nonphysician eligible professionals (for example, 
groups with only nurse practitioners or physician assistants). We also 
proposed to modify the definition of ``group of physicians'' under 
Sec.  414.1205 to also include the term ``group'' to reflect these 
proposals. We also proposed to apply 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 policies established in 
earlier 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 policies 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 
section 1848(k)(3)(B) of the Act. This section defines an eligible 
professional as any of the following: (1) A physician; (2) a 
practitioner described in section 1842(b)(18)(C) of the Act: Physician 
assistant, nurse practitioner, clinical nurse specialist, certified 
registered nurse anesthetist, certified nurse-midwife, clinical social 
worker, clinical psychologist, registered dietician, or nutrition 
professional; (3) a physical or occupational therapist or a qualified 
speech-language pathologist; or (4) a qualified audiologist.
    Beginning CY 2017, under our proposal, the VM would 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 
during the applicable 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 apply to the 
physicians who bill under that TIN.
    This proposal was consistent with our stated 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 group practice level and by focusing on the total 
costs of care, not just the costs of care furnished by an individual 
physician.
    Moreover, section 1848(p)(5) of the Act requires us to, as 
appropriate, 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 processes and workflows that (1) 
make effective use of information technologies, (2) develop effective 
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 the group, would enhance the group's ability and 
resources to redesign processes and workflows to achieve these 
objectives and furnish high-quality and cost-effective clinical care 
with greater care coordination (79 FR 40496).
---------------------------------------------------------------------------

    \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, Battles JB, 
Keyes MA, Grady ML, editors. Advances in Patient Safety: New 
Directions and Alternative Approaches, Vol 2: Culture and Redesign. 
AHRQ Publication No. 08-0034-2. Rockville, MD: Agency for Healthcare 
Research and Quality; August 2008. p. 321-330.
---------------------------------------------------------------------------

    As mentioned above, we also proposed to apply the VM to groups that 
consist only of nonphysician eligible professionals, as well as solo 
practitioners who are nonphysician eligible professionals beginning in 
CY 2017 (79 FR 40496). Consistent with the application of the VM to 
groups of

[[Page 67937]]

physicians and groups that contain both physicians and nonphysician 
EPs, the quality of care composite for groups that consist only of 
nonphysician EPs and solo practitioner nonphysician EPs would be based 
on the quality data 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 practitioners under 
the attribution methodology proposed in section III.N.4.j of the 
proposed rule to calculate cost measures, we proposed 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 composite as ``average'' 
as specified in Sec.  414.1270. We solicited comments on all of our 
proposed policies for applying the VM to nonphysician eligible 
professionals 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 eligible 
professionals beginning in CY 2017.
    Comment: Several commenters supported our proposal to apply the VM 
to nonphysician eligible professionals beginning in CY 2017. These 
commenters stated that the proposal would support the goal of shared 
accountability and urged CMS to include their cost and quality data in 
the QRURs. Some of the commenters wanted nonphysician eligible 
professionals 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 specifically concerned about nonphysician eligible 
professionals who are solo practitioners 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 that nonphysician 
eligible professionals may be included in the VM in the future; 
nonphysician eligible professional groups have not yet received a QRUR; 
nonphysician eligible professionals have not received targeted 
education regarding application of the VM to them; and the proposal 
does not allow nonphysician eligible professionals 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. Other 
commenters indicated that some nonphysician eligible professionals 
groups will not 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 PQRS program. A few commenters proposed a phased-in approach for 
implementation of the VM for nonphysician eligible professionals, which 
they stated would be consistent with the implementation of the VM for 
physician groups.
    Response: We agree with the commenters that 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 finalizing our proposal to apply the VM beginning 
in the CY 2017 payment adjustment period to nonphysician eligible 
professionals in groups with two or more eligible professionals and to 
nonphysician eligible professionals who are solo practitioners. 
Instead, we are finalizing that we will apply the VM beginning in the 
CY 2018 payment adjustment period to nonphysician eligible 
professionals in groups with two or more eligible professionals and to 
nonphysician eligible professionals who are solo practitioners. We 
added paragraph (a)(4) to Sec.  414.1210 to reflect this policy. We 
note that in the CY 2015 PFS proposed rule, we did 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 calendar years prior to the beginning of the 
payment adjustment year (for example, CY 2013 was the performance 
period for the VM applied in CY 2015). We expect to propose the 
performance period for the CY 2018 payment adjustment period for the VM 
in the CY 2016 PFS proposed rule.
    We believe that delaying the implementation 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 the PQRS program and 
to become knowledgeable about the policies for calculating the VM. 
Information about the VM is available on the VM/QRUR Web site at http://www.cms.gov/Medicare/Medicare-Fee-for-Service-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 physicians 
and nonphysician eligible professionals who bill under a group's TIN. 
We are finalizing that we will apply the VM beginning in CY 2018 to 
groups that consist only of nonphysician eligible professionals (for 
example, groups with only nurse practitioners or physician 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 during the 
applicable performance period. During the payment adjustment period, 
all of the nonphysician eligible professionals who bill under a group's 
TIN will be subject to the same VM that will apply to the physicians 
who bill under that TIN. We are finalizing the proposed modification to 
the definition of ``group of physicians'' under Sec.  414.1205 to also 
include the term ``group'' to reflect these final policies. We are also 
finalizing the policy to apply the VM beginning in CY 2018 to 
nonphysician eligible professionals who are solo practitioners.
    Additionally, we are finalizing that beginning in CY 2018, 
physicians and nonphysician eligible professionals will be subject to 
the same VM policies established in earlier rulemakings and under 
subpart N. For example, nonphysician eligible professionals will be 
subject to the same amount of payment at risk and quality-tiering 
policies as physicians. We are finalizing the proposed modifications to 
the regulations under subpart N accordingly.
    However, since CY 2018 will be the first year 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 
solo practitioners harmless from downward adjustments under the 
quality-tiering methodology in CY 2018. We will add regulation text 
under Sec.  414.1270 to reflect this policy when we establish the 
policies for the VM for the CY 2018 payment adjustment period in future 
rulemaking.

[[Page 67938]]

c. Approach to Setting the VM Adjustment Based on PQRS Participation
    In the CY 2014 PFS final rule with comment period (78 FR 74767-
74768), we adopted a policy to categorize groups of physicians subject 
to the VM in CY 2016 based on a group's participation in the PQRS. 
Specifically, we categorize 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 
quality 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 quality measures as individuals for the CY 2016 PQRS 
payment adjustment, or in lieu of satisfactory reporting, 
satisfactorily participate in a PQRS-qualified clinical data registry 
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 criteria 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-category approach for the CY 2017 
VM based on participation in the PQRS by groups and solo practitioners 
(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 proposed that Category 1 would 
include those 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 reporting 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 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. 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 claims, EHR, and registry reporting mechanisms 
and for satisfactory participation in a qualified clinical data 
registry 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 the criteria for 
satisfactory 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 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 would 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 proposed rule (79 FR 
40505), for CY 2017, we proposed to apply a -4.0 percent VM to groups 
with two or more eligible professionals and solo practitioners that 
fall in Category 2. We solicited comment on these proposals.
    The following is summary of the comments we received on these 
proposals.
    Comment: A number of commenters supported our proposal to continue 
to account for eligible professionals that participate in the PQRS as 
individuals in the determination of groups and solo practitioners that 
would be in Category 1. One commenter indicated 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 
the use of both group and individual reporting mechanisms to determine 
whether a group falls 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 individuals 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 stated in the CY 2014 PFS 
final rule with comment period (78 FR 74767), one of the principles 
governing 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 mechanisms to ensure 
physicians and groups of physicians report data on quality measures 
that reflect their practice.
    Furthermore, we do not believe that comparing 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 professionals 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 comments 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 the criteria for satisfactory 
reporting of data on PQRS quality measures via the GPRO (through use of 
the web-interface, EHR, or registry reporting mechanism, as

[[Page 67939]]

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 the PQRS 
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 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 comment period. Our final 
criteria for satisfactory reporting by individual eligible 
professionals for the claims, EHR, and registry reporting mechanisms 
and for satisfactory participation in a qualified clinical data 
registry for the CY 2017 PQRS payment adjustment are described in 
section III.K of this final rule with comment period. Lastly, we are 
finalizing to include in Category 1 those solo practitioners that meet 
the criteria for satisfactory 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 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 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 include 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 comment 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 
finalizing policies to (1) apply a -4.0 percent VM to groups with 10 or 
more eligible professionals that fall in Category 2, and (2) apply a -
2.0 percent VM to groups with two to nine eligible professionals and 
solo practitioners 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 satisfactory reporting (or the 
criteria for satisfactory participation, in the case of solo 
practitioners and the 50 percent option described above for groups) 
must be met during the reporting periods occurring 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.
    In the CY 2014 PFS final rule with comment period (78 FR 74768-
74770), we finalized that the quality-tiering methodology will apply to 
all groups in Category 1 for the VM for CY 2016, except that groups of 
physicians with between 10 and 99 eligible professionals would be 
subject only to upward or neutral adjustments derived under the 
quality-tiering methodology, while groups of physicians with 100 or 
more eligible professionals 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 
between 10 and 99 eligible professionals would be held harmless from 
any downward adjustments derived from the quality-tiering 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 eligible 
professionals and solo practitioners would be subject only to upward or 
neutral adjustments derived under the quality-tiering methodology, 
while groups with 10 or more eligible professionals would be subject 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 eligible professionals in Category 1 would be 
held harmless from any downward adjustments derived from the quality-
tiering methodology for the CY 2017 VM. Accordingly, we proposed to 
revise Sec.  414.1270 to reflect these proposals. We believe this 
approach would reward groups and solo practitioners that provide high-
quality/low-cost care, reduce program complexity, and would also 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.
    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 eligible 
professionals and solo practitioners in Category 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 professionals during the first year the VM applies 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 therefore, 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 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 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 
practitioners. 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 
practitioners. Then, during the summer of 2015, we intend to 
disseminate QRURs 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 also include additional information about the 
TINs' performance on the MSPB measure, individually-reported PQRS 
measures, and the specialty-adjusted cost measures.
    Thus, we stated that we believe groups with between 10 and 99 
eligible

[[Page 67940]]

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 quality-tiering methodology to 
groups with 10 or more eligible professionals in 2017.
    Based on an analysis of CY 2012 claims, we estimate that 
approximately 6 percent of all eligible professionals are in a Category 
1 TIN that would be classified in tiers 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 
significant, approximately 11 percent 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 that is at 
least 1 standard deviation away from the mean composite and it is 
statistically significant, and approximately 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-tiering 
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 that we will continue to 
monitor the VM program and continue to examine the characteristics 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 reflect 
consistent differences in performance among physicians and physician 
groups.
    The following is a summary of the comments we received on these 
proposals.
    Comment: Several commenters supported applying 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 practices. Most commenters strongly supported our proposal to 
hold harmless groups with two to nine eligible professionals and solo 
practitioners from downward payment adjustments in CY 2017, although 
one commenter suggested that CMS should apply downward adjustments to 
them. Some commenters supported our proposal 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 commenter 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 suited to 
absorb downward payment adjustments under the VM. Some commenters were 
concerned that implementation of the downward adjustment to smaller 
physician practices, particularly given that the downward adjustment is 
slated to be -4.0 percent in 2017, may negatively impact beneficiary 
access to care. Other comments stated that solo practitioners and 
groups with two to twenty-four eligible professionals would not have a 
QRUR until the fall 2014 and will have little time to analyze their 
performance data. A number of commenters recommended more intermediate, 
phased-in approach to the downward adjustment such as holding harmless 
groups with less than 25 eligible professionals, 50 eligible 
professionals, or all groups regardless of size. Commenters 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 
adjustment under the VM. One commenter suggested that the payment 
adjustments under quality-tiering apply to all groups regardless of 
size so that primary care physicians who practice in larger groups are 
not disadvantaged, while another suggested that CMS should not change 
the program in 2017. Some commenters requested demographic information 
about the outliers that would receive upward or downward adjustments 
based on quality-tiering.
    Response: We appreciate the commenters' support of our proposal to 
apply the quality-tiering methodology to all groups and solo 
practitioners in Category 1 for the VM for CY 2017 and to hold solo 
practitioners and groups with two to nine eligible professionals in 
Category 1 harmless from any downward adjustments derived 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 professionals 
in CY 2017. For groups with 10 or more eligible professionals, we 
believe it is appropriate 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 eligible 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 
September 2014, we made available QRURs based on CY 2013 data to all 
groups of physicians and physicians who are solo practitioners. 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 quality-tiering methodology to groups with 10 or more 
eligible professionals in 2017.
    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 policy to apply a -2.0 percent VM to groups 
with two to nine eligible professionals and solo practitioners that 
fall in Category 2. We believe the revised policy will alleviate some 
of the commenters' 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 
quality 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 performance in CY 2013. Each QRUR 
contains the group or solo practitioner's performance information 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 adjustment 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 Category 1 harmless from any

[[Page 67941]]

downward adjustments 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 applies to them (CY 
2016). 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 quality-tiering methodology for the CY 
2017 VM. We believe that these groups have had sufficient time to 
understand how the VM works and how to participate in the PQRS. We note 
that the 2013 QRUR Experience Report, as described in section III.N.4.a 
of this final rule, will also contain additional information about the 
groups that were determined to have cost and/or quality performance 
that was significantly different than average, as determined under the 
policies established for the VM for the CY 2015 payment adjustment 
period. We reiterate our belief that the final policies will reward 
groups and solo practitioners that provide 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 received, we are finalizing 
the application of 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 eligible professionals and solo practitioners 
would be subject only to upward or neutral adjustments derived under 
the quality-tiering methodology, while groups with 10 or more eligible 
professionals would be subject to upward, neutral, or downward 
adjustments derived under the quality-tiering methodology. In other 
words, solo practitioners and groups with two to nine eligible 
professionals in Category 1 would be held harmless from any downward 
adjustments derived from the quality-tiering methodology for the CY 
2017 VM.
d. Application of the VM to Physicians and Nonphysician Eligible 
Professionals That Participate in the Shared Savings Program, the 
Pioneer ACO 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 
Accountable Care Organizations (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 
perspective, 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 group participate(s) in one of these programs or initiatives 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 the 
Secretary discretion to apply the VM beginning on January 1, 2015 to 
specific 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 starting in 
CY 2017. In section III.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 two or more 
eligible professionals and to solo practitioners who are nonphysician 
eligible professionals. We describe in this section how we proposed to 
apply the VM beginning in the 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 Professionals That Participate 
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 eligible professionals and to 
physicians and nonphysician eligible professionals who are solo 
practitioners participating in the Shared Savings Program (79 FR 
40497). Groups and solo practitioners participate in the Shared Savings 
Program as part of an ACO as provided in section 1899 of the Act. Under 
the Shared 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. This 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 option is 
available under the existing language of the statute or that, if CMS 
believes it does not have this authority, we should seek it from 
Congress. Commenters also expressed concern that applying the VM to 
participants in the Shared Savings Program would cause inappropriate 
comparisons of performance and create confusion by sending mixed 
signals about cost and quality benchmarks. Several of these commenters 
stated that organizations participating in Shared Savings Program and 
Pioneer ACOs are making significant investments and that they believe 
this further underscores the importance of allowing these groups to 
focus on one set of pay for performance metrics to avoid creating 
additional investment costs. A few commenters supported the application 
of the VM to Shared Savings Program participants because they believe 
that applying the VM broadly will encourage value-based change.
    Response: We disagree with commenters who 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 these 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

[[Page 67942]]

sections 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 
finalizing 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 physicians who are solo practitioners that 
participate in an ACO under the Shared Savings Program.
    We note that, in response to commenters' concerns, we are not 
finalizing the proposal to apply the VM to nonphysician eligible 
professionals in the CY 2017 payment adjustment period that participate 
in an ACO under the Shared Savings Program, consistent with the final 
policy for groups and solo practitioners that do not participate in the 
Shared Savings Program as discussed in section III.N.4.b of this final 
rule with comment period. Also, consistent with our policy discussed in 
section III.N.4.b to apply the VM beginning with the CY 2018 payment 
adjustment period to nonphysician eligible professionals who are not in 
an ACO under the Shared Savings Program, we will apply the 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 policies 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 Savings Program 
during the performance period for the VM, rather than participation 
during the payment adjustment period for the VM as proposed.
    (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 groups and solo practitioners (as identified by 
the ACO's participant TINs) that participate in the Shared Savings 
Program during the payment adjustment period (for example, CY 2017) (79 
FR 40498). We proposed to apply ``average cost'' to these groups and 
solo practitioners regardless of whether they participated in the 
Shared Savings Program during the performance period (for example, in 
CY 2015 for the CY 2017 VM). We believe that it would not be 
appropriate to apply the quality-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 benchmarks 
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 expenditures for beneficiaries that would 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 significant differences in the methodology 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 
practitioners 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 having two sets of 
standards for participants in ACOs for cost performance would be 
inappropriate 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.
    For groups and solo practitioners 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 apply 
the quality-tiering methodology to calculate the cost composite for the 
VM for the payment adjustment period based on the groups' and solo 
practitioners' performance on the cost measures, as identified under 
Sec.  414.1235, during the performance period (79 FR 40499). We stated 
that it would be appropriate to calculate their cost composite under 
the quality-tiering methodology because these groups and solo 
practitioners are no longer part of the Shared Savings Program during 
the payment adjustment period.
    Comment: As noted above, many commenters expressed concern that 
applying the VM to ACO participants in the Shared Savings Program 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 application of the VM to Shared 
Savings Program ACO participants suggested that we should continue 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 performance 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 with our proposed policy 
because it limits the potential upward adjustment under the VM 
available to groups and solo practitioners participating in the Shared 
Savings Program.
    Response: We understand the concerns presented by these commenters 
that calculating a cost composite for these groups and solo 
practitioners could cause confusion and send mixed signals. The VM and 
Shared Savings Programs are 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 composite for groups and solo practitioners participating in an 
ACO under the Shared Savings Program as ``average cost'' 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 investigate the 
possibility of calculating a VM cost composite at the ACO level in the 
future, so that groups and solo practitioners in ACOs would have the 
opportunity to earn the full upward adjustment in the future, and we 
would address this issue in future rulemaking.
    Comment: We received several comments objecting 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 practitioners that join a Shared Savings 
Program ACO in the

[[Page 67943]]

payment adjustment period, but were not in a Shared Savings Program ACO 
in the performance period. These commenters pointed out that this 
policy could 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 period. 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 the opportunity to ``opt in'' to having their cost composite 
calculated regardless 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 adjustment 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 who raised concerns with 
our proposal to consider a group or solo practitioner's participation 
in a Shared Savings Program ACO during the payment adjustment period 
for the purpose of determining the applicability of the VM to the group 
or solo practitioner. We believe that commenters have accurately 
pointed out that Shared Savings Program ACO participants would be 
working toward a specified set 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 the 
associated payment adjustment period. We agree with the points raised 
in the comments about assessing a group or solo practitioner 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 Savings 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 be 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 for cost performance would be inappropriate and confusing. We 
believe that the Shared Savings Program has the potential to reduce 
expenditure 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 intent, 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 
practitioners 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 participating in 
Shared Savings Program ACOs. We believe that allowing groups and solo 
practitioners who participate in the Shared Savings Program in the 
performance period to ``opt in'' to having their cost composite 
calculated would conflict with our intent to avoid setting multiple 
financial benchmarks for these groups and solo practitioners.
    After considering the public comments received, we are finalizing 
our policy to classify the cost composite as ``average cost'' for 
groups and solo practitioners that participate in an ACO under the 
Shared Savings Program. Unlike our proposed policy, which considered 
participation in a Shared Savings Program ACO during the payment 
adjustment period for the VM (for example, CY 2017), we are finalizing 
a policy that, if a group or solo practitioner participates in a Shared 
Savings Program ACO during the applicable performance period (for 
example, the CY 2015 performance period for the CY 2017 payment 
adjustment period), then that group or solo practitioner's cost 
composite will be classified as ``average cost,'' regardless of whether 
the group or solo practitioner participates in a Shared Savings Program 
ACO during the payment adjustment period. In addition to addressing 
some of the concerns raised by commenters, we believe this final policy 
is consistent with our existing policy for CYs 2015 and 2016, under 
which a group's participation in the Shared Savings Program during the 
performance period (CYs 2013 and 2014, respectively) is relevant for 
purposes of determining whether to exempt the group from application of 
the VM during the relevant payment adjustment period. Further, 
utilizing the performance period for the purpose 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 factors after the 
final ACO participation list is completed, as we had proposed to do (79 
FR 40506).
    As requested by commenters, this final 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 payment 
adjustment period, we proposed to calculate the quality of care 
composite score for the VM for groups and solo practitioners who 
participate in an ACO under the Shared Savings Program in accordance 
with the following policies (79 FR 40498-40499):
    <bullet> We proposed to calculate the quality of care composite 
score based on the quality-tiering 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 period and apply the 
same score to all of the groups and solo practitioners 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 practitioners 
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 Sec.  414.1230 from the calculation 
of the quality of care composite score for groups and solo 
practitioners who participate in the Shared Savings Program as 
described in section III.N.4.d.1 of this final rule with comment 
period.
    <bullet> For groups and solo practitioners who participate in the 
ACO during the payment adjustment period (for

[[Page 67944]]

example, CY 2017) and either did not participate in the Shared Savings 
Program or were part of a different ACO during the performance period 
(for example, CY 2015), we proposed to calculate the quality of care 
composite score 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 practitioner is in ACO 1 during CY 2017, 
and either was not in the Shared Savings Program or was 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 individual 
professional's performance from one TIN to another TIN (see 77 FR 69308 
through 69310). In other 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 payments for 
items and services billed under TIN B during the payment adjustment 
period.
    <bullet> 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 period but did not exist 
during the performance period, we proposed to classify the quality of 
care composite for all groups and solo practitioners who participate in 
the ACO during the payment adjustment 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 other words, regardless of whether they 
participated in the Shared Savings Program as part of a different ACO, 
or did not exist during the performance period (for example, a TIN 
forms or newly enrolls in Medicare after the end of the performance 
period). We believed this proposal was appropriate since we would not 
have the ACO's quality data from the performance period to calculate a 
quality of care composite for all of the groups and solo practitioners 
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 appropriate to use the groups' and solo 
practitioners' PQRS or other ACO quality data from the performance 
period to calculate a quality of care composite because the groups and 
solo practitioners 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 individual 
professional's performance 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 period, to participating in ACO 1 in the 
payment adjustment period), then we proposed that we would not 
``track'' or ``carry'' ACO 2's quality data or the TIN's PQRS quality 
data to determine the quality of care composite for groups and solo 
practitioners who participate in ACO 1.
    <bullet> For groups and solo practitioners 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 the 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 use the ACO's quality data 
from the performance period to calculate a quality of care composite 
because the groups and solo 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 these 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 
composite for these groups and solo practitioners for the payment 
adjustment period.
    We solicited comments on all of our proposals to calculate the 
quality composite for groups and solo practitioners participating in 
the Shared Savings 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 Center initiatives. Under this suggested 
approach, groups and solo practitioners participating in the Shared 
Savings Program or other Innovation Center initiatives would receive 
``average cost'' and ``average quality'' unless they opted to have 
their VM calculated. The reasoning behind this approach, provided by 
commenters, is to allow ACOs and the participating groups and 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 practitioners 
could lead to ``double counting'' positive or negative performance. A 
few commenters stated that if we are to apply the VM to groups and solo 
practitioners in the Shared Savings Program, they should only be 
subject to a neutral or an upward adjustment. Some commenters supported 
our proposed policies related to cost and quality composites, and one 
commenter stated that if the VM is applied to these groups, they 
believed that only a quality composite should be calculated because 
they believe that ACOs are already rewarded for reducing costs. 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 Savings Program, which we address in 
section III.N.4.h of this final rule with comment period.
    Response: We appreciate commenters' concern about the potential for 
conflicting incentives on cost and quality performance when applying 
the VM to Shared Savings Program participants given that these 
participants are already 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 
quality composite for groups and solo practitioners participating in 
the Shared Savings Program based on the ACO's quality data. We 
appreciate the support of

[[Page 67945]]

commenters who agreed that it is appropriate 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 
inappropriate to calculate a VM for groups and solo practitioners that 
participate in the Shared Savings Program because this could be seen as 
``double counting'' performance. We believe that application of the VM 
to providers who participate in the Shared Savings Program reinforces 
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 Savings Program participants, 
we should only calculate the quality composite. However, we would like 
to point out that the Shared Savings Program does also reward high 
quality care in addition to rewarding reductions in cost growth. Unlike 
the differences between the methodologies for evaluating costs under 
the Shared Savings Program and the VM, we do not believe that the 
differences 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 specifically, 
the cost measures and cost benchmarks used to determine the cost 
composite under the VM are different than the methodology used to 
calculate financial performance 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 
composite 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 calculate 
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 quality composite for groups and solo practitioners that 
participate in ACOs under the Shared Savings Program we are providing 
an additional incentive to improve the quality of care for their 
beneficiaries. 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 would be appropriate to allow groups 
or solo practitioners to ``opt in'' to having their VM calculated based 
on the TIN's, rather than the whole ACO's, performance. Allowing groups 
or solo practitioners to ``opt in'' to having their own VM 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 outside 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 solo 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 the performance period could 
discourage groups and solo practitioners from joining an ACO in the 
payment 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 that 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. This 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 adjustment 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 practitioner's status in the payment 
adjustment period could discourage future participation in the Shared 
Savings Program. Consistent with our response to the cost composite 
comments, we believe that it would be inappropriate to ignore the 
quality performance of a group or solo practitioner in the performance 
period because they choose to join an ACO in the payment adjustment 
period, as well as in the opposite scenario (if a group or solo 
practitioner participated in an ACO in the performance period and then 
left the ACO in the payment adjustment period). As discussed in our 
earlier response, we believe it would be appropriate to use the ACO's 
quality performance because the group or solo practitioner was part of 
the ACO during the performance period and should be assessed based on 
the incentives that existed during the performance period. Our proposal 
to consider a group or solo practitioner's participation 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 received 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 performance period to 
determine how the VM should be applied. Given that we would have ACO-
level quality data available for group and solo practitioners that were 
in an ACO in the performance period, we believe this data should be 
used to calculate a quality composite for those groups and solo 
practitioners. 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 the performance period, not the payment adjustment period when 
applying the VM to groups and solo practitioners that are in the Shared 
Savings Program. As noted above, it is also 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 composite section 
III.N.4.d.1.b, utilizing the performance period for the purpose 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

[[Page 67946]]

the payment adjustment factors after the final ACO participation list 
is completed, as we had proposed to do (79 FR 40506). We are also 
convinced 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 composite, 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 calculate the quality composite for that group 
or solo practitioner. Although we did not receive specific comments on 
this policy, we believe that based on the other comments received and 
the policy 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 identified by taxpayer identification number (TIN)) 
status during the performance period, rather than the payment 
adjustment period to determine how the group's or solo practitioner's 
quality and cost composite should be calculated, we also believe this 
is the appropriate approach for groups and solo practitioners that move 
between ACOs. We have previously stated our rationale for using the 
performance period to determine a TIN's association with an ACO and we 
believe that reasoning applies 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 period and a different ACO during the 
payment adjustment period) than in the other scenarios previously 
discussed.
    After considering the public comments received, we are finalizing a 
policy to calculate a quality of care composite score based on the 
quality-tiering methodology using quality data submitted by a Shared 
Savings Program ACO during 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 
considered whether a group or solo practitioner participates in a 
Shared Savings Program ACO during the payment adjustment period for the 
VM (for example, CY 2017), our final policy is if a group or solo 
practitioner participates in a Shared Savings Program ACO during the 
applicable performance period (for example, the CY 2015 performance 
period for the CY 2017 payment adjustment period), then that group or 
solo practitioner's quality composite is calculated using the ACO-level 
quality data from the performance period, regardless of whether the 
group or solo practitioner participates in a Shared Savings Program ACO 
during the payment adjustment period. The VM calculated under this 
policy will apply to all physicians billing 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 
professionals billing under the group's TIN, 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 
consider 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 should ensure that those groups and solo practitioners 
participating in the ACO are not subject to the automatic downward 
adjustment.
    Response: We appreciate commenters raising these questions and 
concerns. We did not specifically address in the proposed rule the 
scenario in which a Shared Savings Program ACO does not successfully 
report on quality as required under the Shared Savings Program during 
the performance period for the VM. We clarify that we intended to adopt 
for groups and solo practitioners that participate in a Shared Savings 
Program ACO the same policy that is generally applicable to groups and 
solo practitioners that fail to satisfactorily report or participate 
under PQRS and thus fall in Category 2 and are subject 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 
participate in a Shared Savings Program ACO under Sec.  414.1210(b)(2). 
Consistent with the application of the VM to other groups and solo 
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 under Sec.  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 section III.N.4.f. We also plan to issue program-specific 
guidance to provide participants with more information about how these 
various situations may be addressed. Our final policy focusing on the 
group or solo practitioner's status in the performance period will 
simplify the operational issues related to determining the answers to 
these questions.
    (d) Treatment of groups with two to nine eligible 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 professionals and solo 
practitioners who are in Category 1 harmless from any downward 
adjustments under the quality-tiering methodology for the CY 2017 
payment adjustment period. We proposed to also hold harmless from any 
downward adjustments groups with two to nine eligible professionals and 
solo practitioners who participate in ACOs under the Shared Savings 
Program during the CY 2017 payment adjustment period based on their 
size during the performance period. We would follow our established 
process for determining group size, which is described at Sec.  
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 ``average cost,'' groups with 10 or more eligible 
professionals participating in the Shared Savings Program would 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 beneficiaries, as proposed in section 
III.N.4.f. We proposed to modify Sec.  414.1210 to reflect these 
proposals.
    Comment: We did not receive any comments on these proposals 
specific to the Shared Savings Program. General

[[Page 67947]]

comments on these proposals are addressed in section III.N.4.c of this 
final rule with comment period.
    Consistent with final policies in this final rule with comment 
period to use a group or solo practitioner's status in the performance 
period to determine participation in the Shared Savings Program, we are 
finalizing a policy to hold harmless from any downward adjustments 
groups with two to nine eligible professionals and solo practitioners 
who participate in ACOs under the Shared Savings Program during the 
performance period (for example, the CY 2015 performance period for the 
CY 2017 payment adjustment period) based on their size during the 
performance period.
    We have modified Sec.  414.1210 to reflect these final policies for 
application of the VM beginning with the CY 2017 payment adjustment 
period to groups and solo practitioners that participate in an ACO 
under the Shared Savings Program ACO.
(2) Physicians and Nonphysician Eligible Professionals That Participate 
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 authorizes the Innovation Center to test 
innovative payment and service delivery models to reduce Medicare, 
Medicaid, or Children's Health Insurance Program (CHIP) expenditures, 
while preserving or enhancing the quality of care furnished to 
beneficiaries under those programs. Therefore, all models tested by the 
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 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 are participating in the 
Pioneer ACO Model, the CPC Initiative, or in other Innovation Center 
initiatives 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 Initiative 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 payment adjustment period and potentially CY 2016 for the CY 
2018 VM payment adjustment period. Under the Pioneer ACO Model, an ACO 
may consist of practitioners from multiple participating groups and 
solo practitioners (as identified by their individual TIN/NPI 
combination). Thus, a group practice may consist of one or more 
eligible professionals who participate in the Pioneer ACO Model and 
other eligible professionals who do not participate in the Pioneer ACO 
Model. In the case of the CPC Initiative, a practice site may 
participate in the model 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 with two or more eligible 
professionals and to physicians and nonphysician eligible professionals 
who are solo practitioners who participate in the Pioneer ACO Model or 
the CPC Initiative during the relevant performance period in accordance 
with the policies described below (79 FR 40500).
    Comment: The majority of comments we received 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 application of the VM to Innovation 
Center initiatives should be waived under section 1115A of the Act. 
Additionally, one organization expressed concern that the number of 
varying approaches to calculating the VM in our proposed rule would be 
too complex to implement and may not create equitable comparisons among 
Pioneer, CPC, other Innovation Center model participants, and other 
individuals and groups under the VM program. This commenter suggested 
that we exempt group practices and solo practitioners who participate 
in the Pioneer ACO Model until that 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 encourage value-
based change.
    Response: We are required to apply the VM to all physicians and 
groups of physicians beginning no later than January 1, 2017, and we 
believe that alignment of the VM program and the Pioneer ACO Model, CPC 
Initiative, and other similar models 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 these commenters and summarized in section 
III.N.4.d.1 regarding calculation of the cost and quality composites 
under the VM, and we address them below, in section III.N.4.d.2.b of 
this final rule with comment period.
    After considering the public comments on this proposal, we are 
finalizing a policy to apply the VM in the CY 2017 payment adjustment 
period, to physicians in groups with two or more eligible professionals 
in which at least one eligible professional participates in the Pioneer 
ACO Model or the CPC Initiative during the performance period, and to 
physicians who are solo practitioners that participate in the Pioneer 
ACO Model or the CPC Initiative during the performance period.
    We note that, in response to commenters' concerns, we are not 
finalizing the proposal to apply the VM to nonphysician eligible 
professionals in the CY 2017 payment adjustment period that participate 
in the Pioneer ACO Model or CPC 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 section III.N.4.b of this final 
rule with comment period.
    (b) Calculation of the cost and quality composite of the VM for 
Pioneer ACO and CPC Initiative participants.
    <bullet> For groups and solo practitioners who participate in the 
Pioneer ACO Model or the CPC Initiative during the performance period 
for 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 model, 
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. Additionally, we 
described several alternatives that we considered to the proposed 
policies. Specifically, we described two alternatives to Scenario 2 
described in the proposed rule (79 FR 40501). Under one alternative, 
for groups that have some eligible professionals participating

[[Page 67948]]

in the model and some eligible professionals that are not participating 
in the model, we considered applying ``average quality'' without regard 
to any PQRS data reported outside of the model. Another alternative we 
considered was to apply ``average quality'' to groups where less than 
50 percent of all eligible professionals in the group meet the criteria 
for satisfactory reporting of data on PQRS quality measures as 
individuals or satisfactorily participate in a PQRS-qualified clinical 
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 
well 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 proposals and the alternatives 
considered.
    Comment: We received comments on our proposals for calculating the 
quality and cost composites for Pioneer ACO Model and CPC Initiative 
participants. As noted in section 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 Pioneer 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 
average to avoid sending what they see as conflicting messages about 
cost and quality benchmarks. These 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. individual 
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 set 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 
suggested that providers participating in Pioneer or CPC should only be 
eligible for upward VM adjustments. Some commenters suggested that 
groups and solo practitioners should 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 commenters who suggested that groups 
and solo practitioners in these models should be classified as 
``average cost'' and ``average quality.'' In section III.N.4.d.1, we 
described our rationale for classifying the cost composite as 
``average'' for groups and solo practitioners that participate in an 
ACO under the Shared Savings Program. Similar to the Shared Savings 
Program, the Pioneer ACO Model and CPC Initiative use a shared savings 
methodology that is significantly different than the cost measures and 
benchmarks used to calculate the cost composite under the VM program. 
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 
incentives. 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 presents 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 
participating in these models could choose to report outside of the 
model through a PQRS reporting mechanism, we may have quality data for 
a subset of groups or for a subset of individuals within a group, 
depending on the reporting mechanism. The policies in our proposed 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 agree 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 create 
conflicting incentives for model participants and several 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 reasons 
stated in response to comments on section III.N.4.d.1. We appreciate 
the support of commenters who agreed that applying the VM to groups and 
solo practitioners in these initiatives would support the VM program 
goals of improving quality and cost efficiency. To the extent possible, 
we intend to provide QRURs showing cost and, where available, quality 
performance on VM measures, to these groups and solo practitioners to 
further 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 based on the cost and quality 
incentives that were in place in the performance period, not the 
payment adjustment period. Under our proposed policies, we would 
calculate a cost composite for groups that participated in Pioneer 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 
portion 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 practitioner in the payment adjustment period does not 
fully acknowledge the incentives that existed for the group or solo 
practitioner in the performance 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 above, we 
believe the differences in methodology between the VM cost measures and 
the methodologies used to determine shared savings under the Pioneer 
ACO Model and the CPC Initiative are significant and that it would be 
inappropriate to

[[Page 67949]]

calculate a cost composite for these groups and solo practitioners. In 
the proposed rule (79 FR 40502), we stated that for groups and solo 
practitioners that 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, 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 performance period. We are modifying 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 ``average cost'' and ``average 
quality''. This is consistent with the policies we are finalizing for 
the groups and solo practitioners 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 participating in the Pioneer ACO Model or CPC Initiative 
during the performance period, 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 
alternative to scenario 2 we considered in the proposed rule (79 FR 
40501), though with a broader application to address commenters' 
concerns about the level of complexity 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 downward 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 participates in 
the Pioneer ACO Model or the CPC Initiative in the performance period. 
Given the concerns about distracting from the goals of the models in 
which 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 performance 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 
regardless of whether the physician 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.
    (c) Treatment of groups of two to nine eligible professionals and 
solo 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 eligible 
professionals and solo practitioners who are in Category 1 harmless 
from any downward adjustments under 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 Sec.  414.1210(c). We also proposed that groups 
where one or more eligible professionals participate in the Pioneer ACO 
Model or the CPC during the performance period, and solo practitioners 
participating 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 beneficiaries, as proposed 
in section III.N.4.f below.
    Comment: We did not receive comments specific to this proposal. The 
comments we received on our general policy to hold harmless groups of 
two to nine eligible professionals and solo practitioners are discussed 
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 
Initiative 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 
eligible 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 Innovation 
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 that 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 fall 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 evaluates the 
quality of care and/or requires reporting on quality measures; (2) the 
model or initiative evaluates the cost 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 
or initiative; or (5) other relevant factors specific to a model or 
initiative. We noted that a model or initiative would not have to 
satisfy or address all of these 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 public 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 criteria 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

[[Page 67950]]

solo practitioners 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 quality'' 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 
innovation, including standing up new infrastructure to capture 
performance on quality measures that could be used in the VM program in 
the future.
    After consideration of the comments, 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 adopted for applying the VM to groups and solo 
practitioners that participate in the Pioneer Model or the CPC 
Initiative to Innovation Center models and CMS initiatives that we 
determine are ``similar'' based on these criteria.
    We recognize that the policies we finalize for the Pioneer ACO 
Model and the CPC Initiative might not be applicable to all of the 
various models and initiatives that could be developed in future years. 
If we believe a different approach to applying 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 participants in the model 
or initiative through the methods of communication that are typically 
used for the model or initiative.
    Additionally, consistent with our final policies 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 the VM to nonphysician eligible professionals in 
similar Innovation Center models or CMS initiatives in the CY 2017 
payment adjustment period.
    We modified Sec.  414.1210 to reflect 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 performance on all Medicare 
FFS beneficiaries--not just MSSP-attributed beneficiaries--through the 
Physician Feedback Program prior to application of the VM program. This 
commenter also stated that CMS should reduce the administrative burden 
associated with the ``opt out'' process for data sharing for Shared 
Savings Program ACOs. Other commenters stated that CMS should adjust 
the financial benchmarks for ACOs based on VM adjustments.
    Response: We appreciate the input from these commenters but believe 
these suggestions are outside the scope of this rule. Data sharing 
policies and financial benchmarking methodologies for the Medicare 
Shared Savings Program are described in the Final Rule for that 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://innovation.cms.gov/initiatives/Pioneer-ACO-Model/.
e. Clarification Regarding Treatment of Non-assigned Claims for Non-
Participating Physicians
    In the CY 2013 PFS final rule with comment period in which we 
established a number of key policies for the VM, we stated that we had 
received few comments on our proposal to apply the VM to the Medicare 
paid amounts for the items and services billed under the PFS so that 
beneficiary cost-sharing or coinsurance would 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 finalized this policy and accordingly 
established a definition of the VM at Sec.  414.1205 that was 
consistent with the proposal 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 furnished compared to 
cost during a performance period.
    We continue to believe that 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. However, in previous 
rulemaking, we did not directly address whether the VM would be applied 
to both assigned services for which Medicare makes payment to the 
physician, and to non-assigned services for which Medicare makes 
payment to the beneficiary. Participating physicians are those who have 
signed an agreement in accordance with section 1842(h)(1) of the Act to 
accept payment on an assignment-related basis for all items and 
services furnished to Medicare beneficiaries. In other words, 
participating physicians agree to accept the Medicare approved amount 
as payment in full and to charge the beneficiary only the Medicare 
deductible and coinsurance amount. In contrast, non-participating 
physicians have not signed an agreement to accept assignment for all 
services furnished to beneficiaries, but they can still choose to 
accept assignment for individual services. If they choose not to accept 
assignment for particular services, non-participating physicians can 
charge the beneficiary more than the Medicare-approved amount, up to a 
limit called the ``limiting charge.'' The limiting charge is defined at 
section 1848(g)(2)(C) of the Act 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 payment from Medicare at the approved amount for non-
participating physicians, which is 95 percent of the fee schedule 
amount. Over 99 percent of Medicare physician services are billed on an 
assignment related basis by both participating and non-participating 
physicians and other suppliers, with the remainder billed as non-
assigned services by non-participating physicians and other suppliers.
    For assigned claims, Medicare makes payment directly to the 
physician. In accordance with section 1848(p)(1) of the Act and the 
regulations at Sec.  414.1205 and Sec.  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 service) 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 non-assigned services directly to the 
beneficiary and the physician receives all payment for a non-assigned 
service directly from the beneficiary. If the VM were to be applied to 
non-assigned services, then the Medicare payment to a beneficiary 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 beneficiaries and not physicians, contrary to 
our intent as discussed in previous rulemaking (77 FR 69309). On that 
basis, we proposed to clarify that we would apply the VM only to 
assigned services and not to non-assigned services starting in CY 2015 
(79 FR

[[Page 67951]]

40504). We do not expect this proposed clarification, to not apply the 
VM to non-assigned 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-assigned 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 nonphysician 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 
proposed clarification.
    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. Some commenters requested a 
similar policy be applied to the payment adjustments for PQRS and EHR 
Meaningful Use. A commenter opposed the proposed clarification, 
encouraging CMS to support non-participating providers by applying the 
value modifier adjustment to non-assigned claims at the group practice 
level (TIN), and to evaluate alternative solutions to paying providers 
other than at the claim level.
    Response: We appreciate receiving the comments that supported this 
technical clarification. However, we are unable to agree with the 
commenter that suggested an alternative approach to apply the VM to 
claims submitted by non-participating physicians. As explained above 
and in the proposal, the application of the 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 those 
submitted by both participating and non-participating physicians, and 
nonphysician eligible professionals to the extent the VM is applied to 
them. Therefore, the VM will affect non-participating physicians to the 
extent that they submit assigned claims.
    With regard to the comment that a similar 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 EHR-
meaningful use adjustments, which apply to the Medicare allowed amount 
rather than the Medicare paid amount.
    After considering the public comments, we are finalizing the 
proposed clarification to not apply the VM to non-assigned claims for 
non-participating physicians, and nonphysician eligible professionals 
to the extent the VM is applied to them.
f. Payment Adjustment Amount
    Section 1848(p) of the Act does not specify the amount of payment 
that should be subject to the adjustment for the VM; however, section 
1848(p)(4)(C) of the Act 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 professional 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 comment 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 professionals 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.
    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 elected quality tiering and were classified as low 
quality/high cost and for groups of physicians in Category 2 (77 FR 
69323-24). Although we received comments suggesting that larger payment 
adjustments (both upward and downward) would be necessary to more 
strongly encourage quality improvements, we finalized our proposed 
adjustments as we believed they better aligned 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 solo practitioners in CY 2017 as 
discussed in section III.N.4.a of this final rule with comment period. 
Therefore, we proposed to increase the downward adjustment 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 practitioners that fall in Category 2. 
In addition, we proposed to increase the maximum downward adjustment 
under the quality-tiering methodology in CY 2017 to -4.0 percent for 
groups and solo practitioners classified 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 practitioners 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. Consistent with our previous policy, we note 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. Accordingly, we also proposed to 
increase the maximum upward adjustment under the quality-tiering 
methodology in CY 2017 to +4.0x for groups and solo practitioners 
classified 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 practitioners that care for high-risk beneficiaries 
(as evidenced by the average HCC risk score of the attributed 
beneficiary population). Lastly, we proposed to revise Sec.  414.1270 
and Sec.  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 payment adjustment amounts 
for CY 2017 (based on CY 2015 performance). We believe that the VM 
amount differentiates between cost and quality-tiers in a more 
meaningful way. We solicited comments on all of these proposals.

[[Page 67952]]



                            Table 87--Proposed CY 2017 VM Payment Adjustment Amounts
----------------------------------------------------------------------------------------------------------------
                      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 and solo practitioners 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.

    The following is summary of the comments we received on all these 
proposals.
    Comment: The majority of the comments were 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 quality/high cost under the quality-tiering methodology to 
-4.0 percent. Commenters expressed their belief that the changes are 
aggressive. Several commenters indicated that CY 2017 will be the first 
year that many physicians and all nonphysician eligible professionals 
will be subject to the VM, and therefore, recommended maintaining the 
maximum downward payment adjustment at -2.0 percent for Category 2 and 
those that are low quality/high cost under the quality-tiering 
methodology. Commenters indicated that many of these groups and solo 
practitioners have not yet received their QRURs; therefore, it would be 
premature to raise the adjustment amount 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-tiering and for Category 2 without providing an 
opportunity for both providers and CMS to understand the implications 
of the 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 practitioners 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 separate the amount at risk for not reporting under the 
PQRS (Category 2) from 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 impact of penalties for 
PQRS, EHR, and the VM would add up to a potential -9.0 percent 
adjustment to Medicare payments and expressed that this cumulative 
impact would 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 commenters indicated it was unfair to hold solo 
practitioners and groups with two to nine eligible professionals at -
4.0 percent 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 practitioners 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 
adjustment and +4.0x upward adjustment factor was not sufficient to 
incentivize physicians to improve quality. A few of these commenters 
suggested that the amount at risk should 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 private 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 should be 
subject to a more gradual phase-in of the VM's application to them, 
consistent with the experience of the larger groups. We acknowledge 
that our proposal would have held solo practitioners and groups with 
two to nine eligible professionals in Category 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 for only -2.0 percent and -1.0 
percent respectively in 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 practitioners 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 
application of the VM. Therefore, we are 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. Specifically, 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 professionals that are in Category 1 harmless from any 
downward adjustments under the quality-tiering methodology in CY 2017, 
if classified as low quality/high cost, low quality/average cost, or 
average quality/high cost. Additionally, for groups with two to nine 
eligible professionals and solo practitioners, we

[[Page 67953]]

are finalizing a policy to set the maximum upward adjustment under the 
quality-tiering methodology in CY 2017 to +2.0x if a group or solo 
practitioner is classified as high quality/low cost and set the 
adjustment to +1.0x if a group or solo practitioner is classified as 
either average quality/low cost or high quality/average cost. Table 88 
shows the final quality-tiering payment adjustment amounts for CY 2017 
(based on CY 2015 performance) for groups with two to nine eligible 
professionals and solo practitioners.
---------------------------------------------------------------------------

    \22\ Francois S. de Brantes & B. Guy D'Andrea. Physicians 
Respond to Pay-for-Performance Incentives: Larger Incentives Yield 
Greater Participation. Am. J. of Managed 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.
---------------------------------------------------------------------------

    For groups with ten or more eligible professionals, we are 
finalizing the payment adjustments as proposed for CY 2017 (79 FR 
40505-40506). As stated 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 the VM prior to the 
CY 2017 payment adjustment period. By CY 2017, groups with 10 or more 
eligible professionals will have had at least one year experience under 
the VM program. 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 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 practitioners. 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 result, 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 set the maximum downward adjustment under the 
quality-tiering methodology in CY 2017 to -4.0 percent for groups with 
ten or more eligible professionals classified as low quality/high cost 
and set the adjustment to -2.0 percent for groups with ten or more 
eligible professionals 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 adjustment 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 continue to provide an 
additional upward payment adjustment of +1.0x to groups with two or 
more eligible professionals and solo practitioners that care for high-
risk beneficiaries (as evidenced by the average HCC risk score of the 
attributed beneficiary population). Lastly, we are finalizing the 
revisions at Sec.  414.1270(c) and Sec.  414.1275(c) and (d) to reflect 
the payment adjustments 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 believe 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 professionals 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 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 additional +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 Adjustment 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 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.

    Consistent with the policy adopted in the CY 2013 PFS final rule 
with comment period (77 FR 69324 through 69325), the upward payment 
adjustment factor (``x'' in Tables 88 and 89) 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 payment 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

[[Page 67954]]

payment adjustment period and their participant TINs during the late 
fall prior to the beginning of the payment adjustment period (for 
example, the late fall of CY 2016 prior to the CY 2017 payment 
adjustment period) (79 FR 40506). We also noted that this final list 
may not be available until after the beginning of the payment 
adjustment period. Therefore, we proposed to calculate preliminary 
payment adjustment 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 participation list is completed. 
We note that the final payment adjustment factors may be updated 
depending on the outcome of the informal inquiry process described 
later at section III.N.4.i of this final rule with comment period.
    We did not receive any comments on these proposals.
    As discussed in section III.N.4.d of this final rule with comment 
period, we are finalizing a policy to use the performance period to 
determine which groups and solo practitioners participate in the Shared 
Savings Program for purposes of calculating their VM in CY 2017. 
Therefore, we are not finalizing our proposal to calculate preliminary 
payment adjustment factors (``x'' in Tables 88 and 89) prior to the 
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 proposal 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 comment period (78 FR 74771 
through 74772), we adopted a policy that performance on quality and 
cost measures in CY 2015 will be used to calculate the VM that is 
applied to items and services for which payment is made under the PFS 
during CY 2017. Accordingly, we added a new paragraph (c) to Sec.  
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 comment 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 mechanisms available to individual eligible professionals in 
CY 2014, such that data that groups submit for quality reporting 
purposes through any of the PQRS group reporting mechanisms in CY 2014 
and the data that individual eligible professionals submit through any 
of the individual PQRS reporting mechanisms in CY 2014 will be used for 
calculating the quality composite under the quality-tiering approach 
for the VM for CY 2016. Moreover, all of the quality measures for which 
groups and individual eligible professionals are eligible to report 
under the PQRS in CY 2014 would 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 FR 74768). We also noted that, 
in accordance with 42 CFR 414.1230, three 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. These 
measures are: (1) A composite of rates of potentially preventable 
hospital admissions for heart failure, chronic obstructive pulmonary 
disease, and diabetes; (2) a composite rate of potentially preventable 
hospital admissions for dehydration, urinary tract 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 align 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 place 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 PQRS reporting periods in CY 2015. These 
reporting mechanisms were described in Tables 21 through 49 of the 
proposed rule (79 FR 40404).
    PQRS Quality Measures: We proposed to continue to use all of the 
quality measures that are available to be reported under these various 
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. These PQRS quality 
measures were described in Tables 21 through 49 of the proposed rule 
(79 FR 40404).
    We proposed that groups with two or more eligible professionals 
would be able to elect to include the patient experience of care 
measures collected through the PQRS CAHPS survey for CY 2015 in their 
VM for CY 2017 (79 FR 40506). We also proposed to continue to include 
the three outcome measures in Sec.  414.1230 in the quality measures 
used for the VM in CY 2017. For groups that are assessed under the ``50 
percent 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 weighted average of 
the performance rates of those eligible professionals reporting the 
measure. We also proposed for groups that are assessed under the ``50 
percent option'' for the CY 2017 VM to classify a group's quality 
composite score as ``average'' under the quality-tiering methodology, 
if all of the eligible professionals in the group satisfactorily 
participate in a PQRS qualified clinical data registry in CY 2015 and 
we are unable to receive quality performance data for those eligible 
professionals. We wish to clarify that in this proposal, the phrase 
``all of the eligible professionals in the group'' refers to the at 
least 50 percent of eligible professionals in the group who report as 
individuals under PQRS. In other words, we proposed for groups that are 
assessed 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 qualified 
clinical data registry 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 using 
a qualified clinical data registry and we are unable to obtain the 
data, but other EPs in the group report data using the other PQRS 
reporting mechanisms for individuals, we would calculate the group's 
score based on the reported performance data that we obtain through 
those other mechanisms (79 FR 40507).
    Although we finalized policies in the CY 2014 final rule with 
comment period that would allow groups assessed under the ``50 percent 
option'' to have data reported through a PQRS qualified clinical data 
registry in CY 2014 used for the purposes of their CY 2016 VM to the 
extent performance data are available, we noted that we did not 
directly address the issue of how we

[[Page 67955]]

would compute the national benchmarks for these measures. Under Sec.  
414.1250, benchmarks for the quality of care measures for the VM are 
the national mean performance rate for a measure during the year prior 
to the performance 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 and 
will therefore not be included in the quality composite. Consistent 
with these existing policies, we proposed to not include 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 measures reported through a PQRS 
qualified clinical data registry in the CY 2014 performance period for 
the CY 2016 payment adjustment period. We welcomed public comment on 
this proposal.
    We noted that the PQRS administrative claims option described in 
Sec.  414.1230, is no longer available through PQRS (79 FR 40507). 
However, we are clarifying that the three claims-based outcome measures 
described in Sec.  414.1230, are still used in calculating the quality 
composite for purposes of the VM. We proposed to clarify that we 
calculate benchmarks for those outcome measures described in Sec.  
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 Sec.  414.1250(b) (79 FR 40507). We welcomed public 
comment on this proposal.
    The following is summary of the comments we received on these 
proposals.
    Comment: Several commenters supported the alignment of VM with PQRS 
requirements. Other commenters, however, raised concerns about the lack 
of applicable quality measures for multiple specialties and 
nonphysician eligible professionals, which they believe could result in 
an automatic downward payment adjustment for professionals who are 
unable to report. Several commenters also suggested CMS should include 
measures in the VM only after physicians had reported on the measures 
under PQRS for at least a year. Several commenters supported our 
proposal to continue our existing VM benchmarking policy for measures 
that are new to PQRS or reported via a Qualified Clinical Data Registry 
(QCDR). Several commenters supported our proposal to allow optional 
reporting of patient experience of care measures for groups of two or 
more physicians. However several commenters urged us to consider 
additional patient experience measures that are relevant 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 should be optional for quality 
tiering for the CY 2017 VM, as the 2013 GPRO web participants are still 
awaiting the results of the survey administration. A number of 
commenters stated that CMS should not make patient experience measures 
a required component of the VM in the future.
    Response: PQRS measures are highly reliable measures for 
understanding the health and functional status of beneficiaries after 
treatment by a participating 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 the 
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 program (77 FR 69315; 78 FR 74773). 
Moreover, we believe group reporting can ameliorate the commenters' 
concerns that the current set of PQRS measures does not capture all of 
the clinical care that some specialists and sub-specialists furnish. We 
also continue to believe that alignment with the PQRS program is an 
important goal for the VM, because it minimizes burden on providers and 
encourages widespread participation in quality reporting.
---------------------------------------------------------------------------

    \23\ Mathematica Policy Research, ``Experience Report for the 
Performance Year 2012 Quality and Resource Use Reports.'' (January 
8, 2014).
---------------------------------------------------------------------------

    As we stated in section III.N.4.a of this final rule with comment 
period, where a group or solo practitioner falls in Category 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 
practitioner's quality composite score would be based on the three 
claims-based outcome measures described at Sec.  414.1230, provided 
that the group or solo practitioner has at least 20 cases for at least 
one of the claims-based outcome measures. As discussed in section 
III.N.4.h of this final rule with comment period, eligible 
professionals and groups concerned about the lack of specialty measures 
to meet PQRS reporting requirements should note that PQRS has a Measure 
Applicability Validation (MAV) process. MAV determines PQRS incentive 
eligibility 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 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-Patient-Assessment-Instruments/PQRS/Downloads/2014_PQRS_Claims_MeasureApplicabilityValidation_12132013.zip. Also, 
please refer to section III.K.2 of this final rule with comment period 
for the final 2017 policies for MAV and the criteria for satisfactory 
reporting for the 2017 PQRS payment adjustment.
    With regard to the commenters' suggestion that the VM should 
include only measures on which physicians have reported under PQRS for 
at least one year, we note that we are maintaining the policy set forth 
in Sec.  414.1250 that benchmarks for the quality of care measures are 
the national mean of a measure's performance rate during the year prior 
to the performance period. Measures reported through a PQRS qualified 
clinical 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 interest in ensuring 
that physicians report on measures for at least one year before they 
are included in the VM. Our current policy achieves that end by 
precluding the use of measures for which no benchmarking data is 
available. We acknowledge the comments suggesting that CMS expand the 
data 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 program and the 
VM. CMS will provide survey results and post benchmarks for the patient 
experience of care measures; this data as well as the survey questions 
that can be accessed on the CMS Web site can be

[[Page 67956]]

utilized to prioritize performance improvement efforts. We also 
acknowledge the commenters' concerns with expansion of mandatory CAHPS 
inclusion in the VM and note that we would propose any such policy 
change through future notice and comment rulemaking.
    After consideration of the comments, we are finalizing our proposal 
to use all of the quality measures that are available to be reported 
under these various 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 policy that groups with two or more eligible 
professionals can elect to include the patient experience of care 
measures collected through the PQRS CAHPS survey for CY 2015 in their 
VM for CY 2017. We are finalizing our policy to continue to include the 
three outcome measures in Sec.  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 professional in the group by 
combining the weighted average of the performance rates of those 
eligible professionals reporting the measure.
    We are finalizing our policy at Sec.  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 professionals in the group who 
report as individuals under PQRS do so by satisfactorily 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 classify the group's quality composite 
score as ``average'' under the quality-tiering methodology. Because 
this is the same policy as for the CY 2016 payment adjustment period, 
we are also making a conforming revision to Sec.  414.1270(b)(4).
    We are finalizing a policy that, for groups that are assessed under 
the ``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 other 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 obtain 
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 that 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 measures submitted via QCDRs, the 
benchmark for quality of care measures will be the national mean for 
the measure's performance rate during the year prior to the performance 
period (Sec.  414.1250). We are finalizing our proposed clarification 
that we calculate benchmarks for the outcome measures described in 
Sec.  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 Sec.  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 that 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 participate 
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 proposed to use the PQRS 
GPRO Web Interface measures and the outcome measure described at Sec.  
414.1230(c) to determine a quality composite for groups and solo 
practitioners who participate in an ACO under the Shared Savings 
Program. Because the ACO GPRO Web Interface measures and PQRS GPRO Web 
Interface measures will be the same in CY 2015, we proposed to use the 
GPRO Web Interface measures reported by ACOs in determining the quality 
composite for groups and solo practitioners participating in ACOs under 
the Shared Savings Program in CY 2017 (79 FR 40507). Utilizing these 
GPRO Web Interface measures in this regard further encourages 
successful quality reporting for Shared Savings Program ACOs. 
Additionally, we stated 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 Sec.  414.1230(c), and therefore, proposed 
use of that measure as calculated for ACOs in the Shared Savings 
Program for inclusion in the VM for the CY 2017 payment adjustment 
period (79 FR 40507). We note that the outcome measures described at 
Sec.  414.1230(a) and Sec.  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 admissions for 
heart failure, chronic obstructive pulmonary disease, and diabetes; and 
(2) a composite rate of potentially 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 modify the regulations at Sec.  412.1210 
accordingly.
    The following is summary of the comments we received on these 
proposals.
    Comment: The majority of commenters opposed the proposals for two 
reasons. First, these commenters expressed their belief that the ACO 
would be required to report measures twice or report additional 
measures. Second, these commenters suggested that aligning the measures 
used in the Shared Savings Program and 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 
different performance benchmarks and different approaches for 
determining good versus bad performance.
    A few medical societies supported the proposals, recognizing CMS's 
intent to align the measures and quality improvement goals of the 
Shared Savings Program and VM program. Several commenters suggested 
allowing groups that are new to GPRO Web Interface reporting to have at 
least one

[[Page 67957]]

year to report measures before 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 commenters' 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 the same. We believe, therefore, that utilizing 
the GPRO web interface measures for Shared Savings Program 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 purposes of the VM. 
Moreover, the use of the GPRO Web Interface measures fosters alignment 
among the various CMS quality reporting programs. With regard to 
commenters' suggestion that Shared Savings Program ACO participants 
might fare well on measures reported under the Shared Savings Program 
and poorly under the VM program, we do not believe this situation is 
likely to occur, because within the Shared Savings Program, ACOs will 
be measured against national benchmarks that are calculated using 
Medicare fee-for service data. The VM program also develops benchmarks 
using all available Medicare fee-for-service data. Although the 
benchmarking methodology differs in that the VM uses a national 
weighted 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 practitioners subject 
to the value modifier.
    Further, we believe it is appropriate to use the Shared Savings 
Program ACOs' all-cause readmission measure for calculating the VM for 
the 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-cause hospital readmission 
measure adopted for the VM. The use of this measure will not impose any 
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 Interface 
measures and the Shared Savings Program ACO all-cause readmission 
measure to calculate a quality composite score for groups and solo 
practitioners who participate 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 Sec.  414.1250. Under this policy, the VM 
benchmarks are the national mean for a measure's performance rate based 
on data from one year prior to the performance period. We believe these 
are the appropriate benchmarks to use when determining the value 
modifier payment adjustment because they are the same benchmarks used 
to determine the value modifier payment adjustment for other groups and 
solo practitioners and they are similar to the benchmarks used under 
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 among groups and solo practitioners and it is appropriate to 
evaluate those that 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 value 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 Program develops 
benchmarks using all available Medicare fee-for-service data, we do not 
believe it is appropriate to use benchmarks from the Shared Savings 
Program to determine 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 the 
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 comments we received on these 
proposals.
    Comment: A number of commenters opposed the proposal for the 
following reasons: The belief that a difference in performance 
benchmarks for the VM and Shared Savings Program could cause ACOs to 
score well in one program and perform poorly in the other; and the 
belief that the application of the VM benchmarking policy 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 that alignment of quality measures for 
the VM and Shared Savings Program would strengthen the benchmarks by 
establishing a larger pool of providers with comparable measures.
    Response: We appreciated the comments received. As stated above, 
with regard to the suggestion that Shared Savings Program ACO 
participants might fare well on measures reported under the Shared 
Savings Program and poorly under the VM program, we do not believe this 
situation is likely to occur, because the GPRO Web Interface measures 
used for the Shared Savings Program ACOs and the VM are the same and 
benchmarks used for performance measurement on use the same data source 
(fee-for-service Medicare data). We also do not 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 under 
Sec.  414.1250 to determine the standardized score for quality measures 
for groups and solo practitioners 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 Sec.  
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 Sec.  414.1265, that a claims-based cost or 
quality measure must have a minimum of 20 cases, to be included in a 
composite score calculation. Furthermore, according to Sec.  
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 
remaining measures in the domain are given equal weight.
    Based on 2012 data, we found that the average reliability for the 
all-cause hospital readmissions measure was

[[Page 67958]]

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 reliability 
threshold, reliability 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 more likely to have 200 or more cases as compared to 
groups with fewer eligible professionals. Thirty percent of groups with 
10 or more eligible professionals had 200 or more cases, as compared to 
3 percent of groups with 1-9 eligible professionals. We found that the 
average reliability exceeded 0.4 for groups of all sizes (1 or more 
eligible professionals), with 200 or more cases.
    After examining the reliability of the all-cause hospital 
readmissions measure data for 2012 across all group sizes and 
considering its impacts on the cost composite of the VM as discussed 
below, we proposed to change the reliability policy (minimum number of 
cases) with respect to this measure. Specifically, beginning with the 
CY 2017 payment adjustment period, we proposed to change the 
reliability policy (minimum number of cases) with respect to the all-
cause hospital readmissions measure as described in Sec.  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 practitioner has fewer 
than 200 cases for the measure during the relevant performance period. 
In implementing this proposal, we noted that we would only apply it to 
the all-cause hospital readmissions measure as it is calculated for 
groups or solo practitioners who are not part of a Shared Savings 
Program ACO. In instances where we are including Shared Savings Program 
data for groups or solo practitioners who are part of a Shared Savings 
Program ACO, we would include their all-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 
consistency with the Shared Savings Program's reporting requirements 
for its participants, to the extent it is practicable. We would 
continue to include the measure in the VM quality domain for groups or 
solo practitioners who have 200 or more cases. We proposed to modify 
Sec.  414.1265 to reflect this proposal. We welcomed comments on this 
proposal.
    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 effect on the VM for groups with between 20 and 199 cases 
through the cost composite of the VM. The Medicare Spending per 
Beneficiary (MSPB) measure, as finalized in the CY 2014 PFS final 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 post-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 episode 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 
incorporated as part of the 5 total per capita cost measures 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 during the year, including the costs of 
readmissions. Therefore, readmission costs 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 adverse 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 hospital 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, thereby improving performance on the 
payment-standardized, risk-adjusted cost measures used for the cost 
composite of the VM.
    The following is summary of the comments we received on this 
proposal.
    Comment: We received few comments on this proposal. Some commenters 
supported the inclusion of the all-cause readmission measure. 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 for hospital admissions to each 
group. Several commenters supported the need for reliable measures; 
however, one commenter expressed concern that even with an increased 
case minimum, the all-cause readmission measure was still not 
appropriate for physician accountability because the readmission costs 
are already included in the total per capita costs, the measure was not 
specified for group level measurement, and the measure was not 
supported by the Measures Application Partnership (MAP). This commenter 
stated that the all-cause readmission measure does not add value to the 
VM, further suggesting that if CMS chooses to keep the measure, then it 
should be adjusted for clinical and socioeconomic factors. Another 
commenter recommended CMS undertake an analysis to ensure this change 
would not result in disproportionate penalties for certain groups (such 
as surgeons) prior to finalizing this proposal.
    One commenter stated that this measure is not appropriate for 
physician practices because 2012 data indicates that the measure could 
not meet a 0.4 percent reliability threshold at a 20-case minimum. This 
commenter also questioned the justification for including a measure 
that will be applicable only to 30 percent of groups with 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 all-cause hospital readmission measure, which 
quantifies 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 reliability exceeded 
0.4 for groups with 200 or more cases included all group sizes (1 or 
more eligible professionals). We are committed to 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 disagree that this fact makes the all-cause 
hospital readmissions measure inappropriate for inclusion in the VM. 
The all-cause hospital readmissions measure is a measure of readmission 
rates, not of costs and we believe that

[[Page 67959]]

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/Medicare/Medicare-Fee-for-Service-Payment/sharedsavingsprogram/Downloads/ACO-8.pdf
    With regard to commenters' concerns related 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 trial period to test the 
impact of sociodemographic factor risk adjustment of performance 
measures (available at http://www.qualityforum.org/Press_Release/2014/NQF_Board_Approves_Trial_Risk_Adjustment.aspx). While we continue to 
evaluate the appropriateness of applying different standards for the 
outcomes of patients of low socioeconomic status and the potential for 
a socioeconomic status adjustment to mask potential disparities 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 future refinements 
to this or any measure included in the VM.
    After consideration of the comments, we are finalizing the policy, 
beginning with the CY 2017 payment adjustment period, to increase the 
case minimum from 20 cases to 200 cases for the all-cause hospital 
readmissions measure as described in Sec.  414.1230(c) to be included 
in the quality composite for the VM as proposed. Therefore, we are 
finalizing the proposal to exclude the measure from the quality domain 
for a group or solo practitioner if the group or solo practitioner has 
fewer than 200 cases 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 Sec.  414.1265.
i. Expansion of the Informal Inquiry Process To Allow Corrections for 
the Value-Based Payment Modifier
    Section 1848(p)(10) of the Act provides that there shall be no 
administrative or judicial review under section 1869 of the Act, 
section 1878 of the Act, or otherwise of the following:
    <bullet> The establishment of the VM;
    <bullet> The evaluation of the quality of care composite, including 
the establishment of appropriate measures of the quality of care;
    <bullet> The evaluation of the cost composite, including the 
establishment of appropriate measures of costs;
    <bullet> The dates of implementation of the VM;
    <bullet> The specification of the initial performance period and 
any other performance period;
    <bullet> The application of the VM; and
    <bullet> The determination of costs.
    These statutory requirements regarding limitations of review are 
reflected in Sec.  414.1280. Despite the preclusion of administrative 
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 
established an informal inquiry process at Sec.  414.1285. We stated 
that we intend to disseminate reports containing CY 2013 data in the 
fall of 2014 to groups of physicians subject to the VM in 2015 and that 
we will make a help desk available to address questions related to the 
reports.
    We stated it would be appropriate 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 requests from 
groups and solo practitioners to review and correct certain other 
errors related to the VM, such as errors made by CMS in assessing the 
eligibility 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 scores; or computing outcome or cost 
measures. We are working to develop and operationalize the 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 Sec.  
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 process, for the CY 2015 payment 
adjustment period, we proposed to establish a deadline of January 31, 
2015 for a group to request correction of a perceived error made by CMS 
in the determination of its CY 2015 VM payment adjustment. 
Alternatively, we solicited comment on a deadline of no later than the 
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 operationally feasible for us to fully 
evaluate errors with regard to quality measure data and accept data as 
described above under section III.K. for 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 the 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 proposed to adjust a TIN's quality-tier if we make 
corrections to a TIN's quality and/or cost composites as a result of 
this initial corrections process. We noted that there would be no 
administrative or judicial 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 expanded 
informal inquiry process at Sec.  414.1285 as described above. However, 
in anticipation of having the necessary operational infrastructure to 
support the reconsideration of quality measure data, we proposed to 
establish a 30-day period that would start after the release of the 
QRURs for the applicable performance period for a group or solo 
practitioner to request correction of a perceived error made by CMS in 
the determination of the group or solo practitioner's VM for that 
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 adjustment 
period. Similar to our proposal for the initial corrections process in 
CY 2015, we would then make a determination regarding the requests 
received. Since we anticipate it would be operationally feasible 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

[[Page 67960]]

proposed to recompute a TIN's quality composite and/or cost composite 
in the event we determine that we have made an error in the 
calculation. We noted that if the operational infrastructure is not 
available to allow this recomputation, we proposed to continue the 
approach 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 correction 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 period 
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:
    <bullet> For 2015, most commenters supported establishing a 
deadline of no later than the end of February 2015, rather than January 
31, to align with the PQRS informal review process.
    <bullet> For subsequent years, most commenters requested a longer 
period of 60 to 90 days (rather than 30 days) that would start after 
the release of the QRURs for the applicable performance period for a 
group or individual to request a correction of a perceived error 
related to the VM calculation.
    In addition, some commenters objected to the 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 believe 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 quality'' rating 
could potentially lead to penalties or lost incentive payments. Some 
commenters suggested that we consider requests for providers to 
resubmit their quality data. Other commenters asked that we provide 
additional clarification regarding what situations will be considered 
in the informal review process.
    Response: We are persuaded by commenters who request that we 
establish later deadlines for the VM informal review process so that 
such deadlines are consistent with those of the PQRS informal review 
process. We agree with these comments since data reported under PQRS is 
an important component of the VM and that corrections to PQRS measure 
rates could affect the calculation of the VM payment adjustment amount. 
Therefore, for the CY 2015 payment adjustment period, the deadline for 
submission 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 longer period beyond 30 
days, which would start after the release of the QRURs for the 
applicable performance period, for a group or individual to request a 
correction of a perceived error related to the VM calculation. However, 
we believe that 60 days, not 90 days, would be a sufficient amount 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 year and make a decision 
whether or not to submit a VM correction request. Establishing a 60-day 
deadline enables us to make corrections prior to, or relatively soon 
after, the start of the applicable payment adjustment year. This helps 
reduce the number of claims that would need to subsequently 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 
measure 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 
calculation of the quality composite. However, we understand the point 
made by a few commenters about this policy. It is possible that an 
``average quality'' rating 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 develop 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 error 
in the calculation.
    After consideration of the public comments received:
    <bullet> For the CY 2015 payment adjustment period, we are: (1) 
Finalizing a February 28, 2015, deadline for a group to request 
correction of a perceived error made by CMS in the determination of its 
VM, and (2) finalizing a policy 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.
    <bullet> Beginning with the CY 2016 payment adjustment period, (1) 
we are finalizing a deadline of 60 days that would start after the 
release of the QRURs for the applicable performance period for a group 
or solo practitioner to request a correction of a perceived error 
related to the VM calculation, and (2) we will take steps to establish 
a process for accepting requests from providers to correct 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 not available to allow this re-
computation, 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 a result of 
this corrections process. We will provide 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 payment-standardized and risk-adjusted 
annual per capita cost measures. To calculate each group's per capita 
cost measures, we first attribute beneficiaries to the group. 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

[[Page 67961]]

the delivery of primary care services (77 FR 69320) by both primary 
care physicians and specialists.
    In the CY 2014 PFS final rule with comment period (78 FR 74780), we 
finalized inclusion of the Medicare Spending Per Beneficiary (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 the measure's performance rate rather than converting it 
to a ratio as is done under the Hospital 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 weighted with the total per capita cost measure in that domain. 
Additionally, we finalized that an MSPB episode is attributed to a 
single group of physicians that provides the plurality of Part B 
services (as measured by standardized allowed charges) during the index 
admission, for the purpose of calculating that group's MSPB measure 
rate. Finally, we finalized a minimum of 20 MSPB episodes for inclusion 
of the MSPB measure in a physician group's cost composite.
    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 create the standardized 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 identify 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 for National 
Quality Forum (NQF) endorsement in January 2013. In the final voting in 
September 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 attribution methodology. Second, we proposed to reverse the 
current exclusion of certain Medicare beneficiaries during the 
performance period. We stated that these proposals would apply 
beginning with the CY 2017 payment adjustment period for the VM and 
would apply to all five of the total per capita cost measures under 
Sec.  414.1235(a)(1) through (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 Sec.  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 care 
service rendered by a physician in the group. Primary care services 
include 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 Geriatric 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-primary care physicians, nurse practitioners (NPs), physician 
assistants (PAs), and clinical nurse specialists (CNSs) together 
provided the plurality of primary care services (as measured by allowed 
charges), as long as at least one primary care service was provided by 
a non-primary care physician in the group.
    To address NQF concerns regarding the attribution methodology of 
the total per capita cost measure, we proposed two modifications to the 
two-step attribution 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 
methodology assigns beneficiaries to the group who had a plurality of 
primary care services rendered by primary 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 primary care services. Consequently, 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 capita cost 
measures under Sec.  414.1235(a)(1) through (5) and the claims-based 
quality measures under Sec.  414.1230.
    Additionally, we proposed to remove the ``pre-step'' described 
above for the purposes of the value modifier. The ``pre-step'' was 
included in the Shared Savings Program assignment methodology to comply 
with the statutory requirement (77 FR 67851) that beneficiary 
assignment be based upon the utilization of primary care services 
furnished by a physician. However, no such limitation exists for the 
VM. Consequently, we proposed to remove the ``pre-step'' 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-step'' would result in streamlining the attribution 
process and attributing 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 assigned 
to group practices made up of nonphysician eligible professionals 
because it would eliminate the criterion 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 Sec.  414.1235(a)(1) 
through (5) and the claims-based quality measures under Sec.  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 Sec.  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 measured 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 primary care services (as measured 
by allowed charges). We proposed these modifications only for groups 
and solo practitioners who are not participating in the Shared Savings 
Program. We noted that for groups and solo practitioners who 
participate in the Shared Savings Program, we would not remove the pre-
step or change the attribution methodology for quality

[[Page 67962]]

measures and cost measures, but would continue to rely on the 
methodology used by the Shared Savings Program to attribute 
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 this two-step attribution 
process for the total per capita cost measures and claims based quality 
measures was that it was aligned with the attribution methodologies 
used by the Shared Savings Program and also the PQRS GPRO Web interface 
(77 FR 69318 through 69320). We recognize that 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 
attribution methodology that was described 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 
attribution method would more appropriately reflect the multiple ways 
in which primary care services are provided, which are not limited to 
physician groups. We welcomed comments on our proposed modification to 
the two-step attribution methodology as applied to the five total per 
capita cost measures under Sec.  414.1235(a)(1) through (a)(5) and to 
the claims-based quality measures under Sec.  414.1230 of the VM.
    The following is summary of the comments we received on our 
proposed modification to the two-step attribution methodology as 
applied to the five total per capita cost measures under Sec.  
414.1235(a)(1) through (5) and to the claims-based quality measures 
under Sec.  414.1230 for the VM.
    Comment: Many commenters opposed our proposal 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 methodology because these nonphysician practitioners are 
not necessarily practicing in a primary care setting. The commenters 
expressed concern that, unlike for physicians, there is no specialty 
distinction on claims billed by NPs, PAs, or CNSs. Therefore, CMS would 
not be able to distinguish between those practitioners 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 commenters 
stated that this would unfairly affect the cost measure calculations 
for specialist groups with large numbers of nonphysician practitioners. 
We did not receive any comments specifically opposing the removal of 
the ``pre-step'' from the methodology. Several commenters supported our 
proposal to modify the attribution methodology. The commenters stated 
that it is important to recognize the role of nonphysician 
practitioners in providing primary care to beneficiaries and that these 
changes create a methodology that more accurately reflects team-based 
approaches to care.
    Response: We appreciate the concerns raised by commenters about the 
potential impact that the lack of specialty designation for NPs, PAs, 
and CNSs could have on the cost and claims based quality measures. 
However, we do not believe that this is likely to occur. In an analysis 
of the impact of including NPs and PAs in step 1 of the attribution 
methodology using 2011 data for groups of twenty-five or more eligible 
professionals, 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 additional analysis and will monitor the 
effect of these changes to ensure they are 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 that many NPs, PAs, and CNSs play as 
primary care providers. The analysis referenced earlier also found that 
the inclusion of NPs and PAs in step 1 resulted in an increase of 2.55 
percent to the number of beneficiaries attributed to a group and the 
number of groups to which at least 20 beneficiaries were attributed 
increased by 3.4 percent. For these reasons, we agree with the NQF 
recommendation to include these nonphysician practitioners in the 
attribution methodology. Further, this attribution change will become 
even more important as we expand the application of the VM to smaller 
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. Beginning 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 rendered by a physician in the group. 
These changes apply to all five total per capita cost measures under 
Sec.  414.1235(a)(1) through (5) and the claims-based quality measures 
under Sec.  414.1230.
    Second, NQF committee members raised concerns about the exclusion 
of certain beneficiaries in the methodology used for the total per 
capita cost measure. Committee members expressed concern that end-of-
life costs were not being captured by the measure. We considered this 
argument and agreed that it is important to include certain 
beneficiaries with these costs during the performance period. As a 
result, we proposed to include certain part-year Medicare FFS 
beneficiaries. This change would affect all five of the total per 
capita cost measures under Sec.  414.1235(a)(1) through (a)(5). The 
change would provide a more complete assessment of end of life costs 
associated with the patients a physician group sees during the year (79 
FR 40510).
    We proposed to continue excluding other part-year beneficiaries 
(those who spend part of the performance period in a Medicare Advantage 
(Part C) plan and those enrolled in Part A only or Part B only for part 
of the performance period and both Part A and Part B for the remainder 
of the performance period) (79 FR 40511). Since 2012 we have applied 
the same attribution rule as that used for the Medicare Shared Savings 
Program and the PQRS GPRO Web Interface (77 FR 69318-20). In this 
regard, excluding part-year Medicare Advantage enrollees would remain 
consistent with the Shared Savings Program and PQRS GPRO Web interface 
reporting policy. If we were to include these part-year 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 
beneficiaries' annual per capita costs appropriately. Similarly, 
Medicare Part A only or Medicare Part B only enrollees who were 
enrolled in both Part A and Part B for only part of the performance 
period would also require a method to impute their costs if they

[[Page 67963]]

were no longer excluded. Furthermore, these Part A only or Part B only 
beneficiaries are excluded from the Shared Savings Program and PQRS 
GPRO methodology.
    We proposed including Medicare FFS beneficiaries who are newly 
enrolled to Medicare during the performance period and enrolled 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 Medicare FFS beneficiaries (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 total per 
capita cost measures under Sec.  414.1235(a)(1) through (5) in the VM.
    Comment: Some commenters opposed our proposal to include certain 
part-year Medicare FFS beneficiaries in the five total per capita cost 
measures because they believe the inclusion of these typically higher 
cost beneficiaries would inappropriately disadvantage groups 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 beneficiaries in the cost measure calculations 
as feasible and especially important to capture the often significant 
costs incurred by beneficiaries at the end of life. One commenter 
suggested that we should develop an end of life specific cost and 
quality measure rather than including these costs in the per capita 
cost measures. We did not receive any comments in opposition to the 
inclusion of newly eligible 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 the support of commenters who supported our 
proposal to include some part-year beneficiaries in the five total per 
capita cost measures. Part-year beneficiaries include those who receive 
end-of-life care, which has been correlated with high-cost 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 substantial percentage of the geographic variation in 
the end-of-life costs. In other words, we believe that the risk 
adjustment system under the VM program explains approximately the same 
extent of costs in the general Medicare population as it does for the 
cohort of Medicare beneficiaries near the end of life.\27\ In response 
to concerns raised by commenters, we conducted additional analyses to 
ensure the inclusion of part-year beneficiaries does not 
inappropriately negatively impact certain groups or solo practitioners. 
This analysis, which we plan to post to the Value Modifier Web site 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 example, for the overall per capita cost 
measure, 83 percent of TINs had reliability equal to or higher 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 beneficiaries, 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 appreciate the suggestion to include cost and quality 
measures that specifically measure care at the end of life and will 
take this into consideration as we continue to develop 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.
---------------------------------------------------------------------------

    \24\ Congressional Budget Office, ``High-Cost Medicare 
Beneficiaries.'' Final Paper (May 2005), available at http://www.cbo.gov/sites/default/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/Geographic-Variation/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.
    \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.
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    We are finalizing our policies as proposed. Beginning in the CY 
2017 payment adjustment period, we will include certain part-year 
beneficiaries in the five total per capita cost measures under Sec.  
414.1235(a)(1) through (5). These part-year beneficiaries include 
Medicare FFS beneficiaries who are at the end of life in the 
performance period and Medicare FFS beneficiaries who are newly 
enrolled in Medicare during the performance period and enrolled in both 
Part A and Part B while 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. First, 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 uncertainty of how to fairly and equitably incorporate 
the costs. Based on data compiled by the Medicare Payment Advisory 
Commission (MedPAC), we estimated that approximately 60 percent of 
Medicare FFS beneficiaries were enrolled in stand-alone Part D in 
2013.\28\ A significant minority of beneficiaries has prescription drug 
coverage from a source that is outside of Medicare--such 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 beneficiaries 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

[[Page 67964]]

approach to address this issue. We welcomed comments on suggested 
methods for including Part D data in the total per capita cost 
measures.
---------------------------------------------------------------------------

    \28\ Please see http://www.medpac.gov/documents/Mar14_EntireReport.pdf for underlying data. We estimated that there 
were 37.3 million Medicare FFS beneficiaries 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).
---------------------------------------------------------------------------

    Comment: Many commenters expressed concern that we are not 
currently including Part D expenditures in our cost measures. These 
commenters 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 harms providers that see 
sicker patients because they believe that these patients are more 
likely to require Part B medications. Several commenters suggested that 
CMS either include Part D costs or exclude Part B drug costs. Others 
suggested excluding only those Part B costs for drugs that have a Part 
D equivalent or capping the Part B costs for certain 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 comments and understand the concerns 
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 fair and consistent manner. We are actively investigating 
options for operationally including Part D costs in our cost measures 
and would propose any viable options under future notice and comment 
rulemaking.
    Comment: We received many comments emphasizing the importance of 
including socioeconomic status in our measures. Commenters believe that 
this is critical to accurately comparing performance between providers 
that serve different populations. 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 
this 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 question. We will 
take the recommendations in this report into account as we consider 
potential future refinements to our risk adjustment methodologies. Any 
changes would be made through rulemaking.
---------------------------------------------------------------------------

    \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_Sociodemographic_Factors.aspx.
---------------------------------------------------------------------------

    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 
attribution methodology to look at ``allowed services,'' rather than 
``allowed charges.'' The commenter believes that by looking at 
``allowed charges'' we may be inaccurately attributing beneficiaries to 
the provider that bills using higher level E&M codes, rather than the 
provider that sees the patient most often.
    Response: We believe that a focus on allowed charges is appropriate 
for attribution in Medicare payment measures, because the intent is to 
assess 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 incentivize 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 performance 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 relevant empirical evidence available at that 
time. We considered this potential policy to expand the performance 
data included for hospital-based physicians and to better align 
incentives for quality improvement and cost control across CMS 
programs. Such a policy would also address public comments we received 
on the CY 2014 PFS proposed rule (78 FR 74775), suggesting that the 
Hospital VBP Program total performance score for the hospital in which 
a specialist practices should be used in the VM. Commenters made this 
suggestion, noting that there were limited 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 hospital's final Hospital VBP Program performance for a given 
performance period would not be available to a group at the time that 
they registered for PQRS reporting, so if we were to establish a 
voluntary policy where groups could elect to include hospital 
performance, they would make the election to have that performance 
included in their VM for a payment adjustment period based on the 
hospital's historic VBP Program performance which would be known to the 
TIN at the time of election.
    We sought public comment on the appropriate methodology to identify 
hospital-based groups and solo practitioners for the purpose of having 
Hospital VBP Program data included or allowing them to elect inclusion 
of Hospital VBP Program performance data in the VM at the TIN level (70 
FR 40511-40512). We suggested that we could either allow self-
nomination or set a threshold based on physician billing, in order to 
determine whether a given physician was hospital-based. We sought 
comment on whether 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 criteria 
to determine whether non-physician eligible professionals should be 
allowed to self-nominate or should automatically have hospital-level 
performance data included in the calculation of their VM. We requested 
public comment on potential methods for determining which hospital or 
hospitals' Hospital VBP Program performance data should be included in 
a physician TIN's VM and how to weight the hospitals, if more than one 
was included (79 FR 40512). We welcomed public comment on the 
approaches we considered, as well as alternative approaches for 
inclusion of all or part of the Hospital VBP Program TPS into the VM. 
In the interest of aligning the HVBP and VM programs, we sought public 
comment on what criteria we should consider in selecting a subset of 
Hospital 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 Hospital VBP Program performance 
into a TIN's VM.
    Comment: Commenters generally supported 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 hospital 
setting. Commenters stated that a 90 percent threshold would be too 
high.
    Response: We appreciate the comments and will take these into 
consideration as we continue to refine

[[Page 67965]]

the VM program and improve the coordination between the HVBP and VM 
programs. We would propose any policy changes through future notice and 
comment rulemaking.
5. Physician Feedback Program
    Section 1848(n) of the Act requires us to provide confidential 
reports to physicians (and, as determined appropriate by the Secretary, 
to groups of physicians) that measure the resources involved in 
furnishing care to Medicare FFS beneficiaries. Section 
1848(n)(1)(A)(iii) of the Act also authorizes us to include information 
on the quality of care furnished 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 fewer than 100 eligible professionals will not be subject to the 
VM in CY 2015. These reports provide clinically meaningful and 
actionable information on several aspects 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 beneficiaries' costs, but also provide data on their 
performance on quality measures they report under the PQRS as well as 
the three outcome measures under Sec.  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 quality 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 
individuals; 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 address a 
specific medical condition or procedure 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 
(groups 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 conditions in the 2011 Supplemental QRURs, the 2012 
Supplemental QRURs included: Chronic congestive heart failure (CHF); 
chronic obstructive pulmonary disease (COPD)/asthma; acute COPD/asthma; 
permanent pacemaker system replacement/insertion; and bilateral 
cataract removal with lens implant. For the 2012 Supplemental QRURs, we 
broke down these episode types into 20 subtypes altogether. In addition 
to these 20 episode subtypes, we included 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 sought comment on the 
three medical and three surgical episode measures that we included in 
the 2012 Supplemental QRURs.
---------------------------------------------------------------------------

    \30\ For Supplemental QRUR purposes, groups were also included 
if they did not to participate in multiple accountable care 
organizations (ACOs) and did not to participate in more than one of 
the following initiatives in program year 2012: The Shared Savings 
Program, the Pioneer Accountable Care Organization (ACO) Model, or 
the Comprehensive Primary Care Initiative (CPCI).
---------------------------------------------------------------------------

    We did not receive any general comments on the 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 procedural) episodes or one 
of the three medical (or acute condition) episodes. Further details on 
attribution rules can be found in ``Detailed Methods of the 2012 
Medical Group Practice Supplemental Quality and Resource Use Reports 
(QRURs)'' at http://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/PhysicianFeedbackProgram/Episode-Costs-and-Medicare-Episode-Grouper.html.
    Specifications for these six clinical episode-based measures, 
including the MS-DRG and procedure codes used to identify each of the 
episodes, and details of episode construction methodology, are 
available in ``Detailed Methods of the 2012 Medical Group Practice 
Supplemental Quality and Resource Use Reports (QRURs)'' at http://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/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 
included 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-based 
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 measures. 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 commenter 
stated that he believes there are inconsistencies and errors in the 
attribution methodology used for episode measures.
    Response: We understand the concerns of specialists, including 
radiology groups, about the challenge of identifying measures for which 
they would have a sufficient number of attributed beneficiaries to have 
the measures calculated. 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 at http://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/PhysicianFeedbackProgram/Episode-Costs-and-Medicare-Episode-Grouper.html.
    We will continue to seek stakeholder input as we develop the 
episode

[[Page 67966]]

framework. We considered proposing to add episode-based payment 
measures to the VM through future rulemaking for all 12 episode 
subtypes, or some subset 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 
episode 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 interventions (PCI) or coronary 
artery bypass graft (CABG), ACS with PCI, ACS with CABG, coronary 
artery disease (now called ischemic heart disease or IHD), IHD without 
ACS, IHD with ACS, CABG without preceding 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 hospital episodes described above. We welcomed public 
comments on the specifications included on the Web site and the 
construction of the episode-based payment measures that we considered.
    The following is summary of the comments we received on the 
specifications included on the Web site and the construction of the 
episode-based payment measures that we considered.
    Comment: Several commenters supported our continued efforts to 
develop episode-based payment measures. Two of these commenters 
indicated that they believe these measures will support better 
coordination of care across settings. One commenter 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 few comments stating that the episode 
measures 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 suggested 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 measures and that we narrow the scope of the 
conditions that are currently included in the episode measures before 
introducing them into the VM.
    Response: We appreciate the input of commenters. We share the 
commenters' beliefs that coordination across care settings 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 regarding 
attribution, tying the cost measures to quality measures and the 
vetting process for measures as we continue to refine the measures and 
consider them for future use in the VM. Developing 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 will 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 contain 
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 updated 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 determine 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 support for the Physician 
Feedback Program and applauded CMS's efforts to improve the QRURs. Many 
commenters stated 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 year. Several commenters 
also suggested that QRURs should be distributed to all providers, 
including nonphysician eligible professionals. Some commenters 
suggested that CMS increase our education and outreach efforts to 
ensure that providers know how to access and use the QRURs.
    Response: We appreciate commenters support for the Physician 
Feedback Program and we will take these comments into consideration as 
we continue to develop and improve the Physician Feedback Program. 
While it is not feasible to provide the annual 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 allow groups and solo practitioners to better track their 
performance on cost and utilization during the year.

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; 
Prospective Payment System for Federally Qualified Health Centers; 
Changes to Contracting Policies for Rural Health 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 rates 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 provisions. In this final rule with comment period, 
we invited comments on how payment for chronic care management (CCM) 
services could promote integrated and coordinated care in FQHCs and 
rural health clinics (RHCs). We also invited comments on the 
modification of our proposed policy to allow exceptions to the FQHC PPS 
per diem payment for 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 under the PPS; and the modification of our proposed approach 
to waiving coinsurance for preventive services when furnished with 
other services under the FQHC PPS.

[[Page 67967]]

1. Promoting Integrated and Coordinated Care in FQHCs and RHCs 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 could help to 
promote integrated and coordinated care in FQHCs and RHCs. We cited the 
CCM information in the CY 2014 PFS final rule with comment period (78 
FR 74230) for physicians billing under the PFS in 2015. We encouraged 
FQHCs and RHCs to review this information and submit comments to us on 
how the CCM services payment could be adapted for FQHCs and RHCs to 
promote integrated and coordinated care.
    We received a few comments regarding how the CCM services payment 
could be adapted for FQHCs in CY 2015 to provide integrated and 
coordinated care in FQHCs. Commenters supported adopting the CCM 
provisions in FQHCs but had concerns about the unique challenges FQHCs 
would face implementing these provisions. The following is a summary of 
these comments.
    Comment: Commenters stated that the seven 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. Commenters 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 the 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 
access 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 supported adopting these provisions for FQHCs 
and suggested that we implement requirements that do not place 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 documenting care coordination and another 
commenter expressed concern for appropriate payment and requested that 
we develop a risk-adjusted per patient per month CCM fee.
    Response: We appreciate the comments and will take them into 
consideration.
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 
length 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 
situations when a patient comes into the FQHC for a medically necessary 
visit, and after leaving 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 paid 
separately for two visits on the same day for the same beneficiary. 
Under the AIR system, we also allowed separate payment 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 and on access to care if 
billing for more than 1 visit per day for these situations was no 
longer permitted. We also considered several alternative options, such 
as an adjustment of the per visit rate when multiple visits occur in 
the same day, or the establishment of a separate per visit rate for 
subsequent 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 though the ability to do so has been in place 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 
underreporting in the data, eliminating the ability to bill for 
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 Sec.  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 solicited comments to address 
whether there are factors that we have not considered, 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 that 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 for subsequent illness or injury occurring 
on the same day as another medical visit. We also modified our proposal 
in the FQHC PPS final rule to allow separate billing for mental health 
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 being utilized. We invited comments on these modifications.
    We received many comments on the modifications to our proposed 
policy, which would allow an exception to the per diem PPS payment for 
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, most of the commenters 
requested additional exceptions to the per diem PPS payment. The 
following is a summary of these comments.
    Comment: Most commenters strongly supported our decision to allow 
separate payment for subsequent injury or illness and mental health 
services furnished on the same day as a medical visit. Commenters 
stated that allowing separate payment for mental health services when 
primary care services are furnished would facilitate integrated and 
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 modification demonstrated 
our commitment to the value of furnishing mental health services in 
FQHCs.

[[Page 67968]]

    Many of the commenters who supported our modification 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 the PPS. Commenters particularly emphasized the need 
for separate payment for DSMT/MNT services 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 provision 
of these services.
    Response: We appreciate the support for allowing an exception to 
the per diem payment when a subsequent injury or illness occurs and for 
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 the 
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 bill 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 subsequent AWVs, in order to appropriately 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 
justify either a separate per-diem payment 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 practitioners 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 visits should be considered differently than other 
primary care services.
    Although the comments we received did not persuade us to allow 
DSMT/MNT to be billed separately in a FQHC when it occurs on the 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 
related illnesses, and we encourage FQHCs to furnish this service as 
necessary.
    We are retaining Sec.  405.2463(c)(4)(i) and Sec.  
405.2463(c)(4)(ii) as finalized in 79 FR 25478, which states that for 
FQHCs billing under the PPS, 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 mental health visit on the same 
day.
3. Establishment of FQHC G-Codes To Report and 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 
FQHC PPS would be 80 percent of the lesser of the provider's actual 
charge or the PPS rate. Commenters were concerned that comparing actual 
charges with a bundled PPS rate would distort the true cost of services 
furnished and would result in FQHCs either being forced to increase 
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 established Medicare patient visit, a new 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 appropriate for 
the services normally provided and the population served at that FQHC, 
and that the charge for a specific payment code would reflect the sum 
of regular rates charged to both beneficiaries 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 dictate to providers how to set their charges, 
and that detailed HCPCS coding with the associated line item charges 
would continue 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 report and 
bill for Medicare visits would allow comparison between the PPS per 
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 comments 
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 implementing 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 would 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 supportive 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 bundles of services will be 
complex for FQHCs. Commenters stated that FQHCs have had limited 
experience working with payors who use a ``lesser of'' or ``actual 
charges'' payment methodology. Commenters acknowledged that Medicare 
regulations require that

[[Page 67969]]

charges must be neutral among payors; however, given that other payors 
and paying patients would not be purchasing a precise bundle of 
services corresponding to the Medicare FQHC visit, commenters 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 used for any non-Medicare patient. Commenters also 
stated that it would be challenging for FQHCs to develop charges for a 
typical bundle of services and adhere to requirements under section 330 
of the Public Health Service (PHS) Act, which requires FQHCs to develop 
charges consistent with locally prevailing rates that cover their 
reasonable costs of operation. Commenters stated that in developing 
actual charges, FQHCs would need to perfect their coding 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 appreciated 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 understanding 
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 
Web site at http://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/FQHCPPS/index.html. Additional information is available in the 
``Medicare Benefit Policy Manual, Chapter 13--Rural Health Clinic (RHC) 
and Federally Qualified 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 typical bundle of services that they would provide to a new 
or established Medicare patient at their FQHC for medical and mental 
health services and IPPE and AWV. We also address how FQHCs set their 
own charges (which must be consistent with the requirements under 
section 330 of the PHS Act when applicable), and since charges must be 
the same for all patients, 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 included in the FQHC G-codes, they will 
adapt well to the process. We would also note that other payors could 
choose to utilize the FQHC payment G-codes if they choose.
    Comment: Many commenters suggested that the use of FQHC payment G-
codes would create an additional administrative burden for FQHCs' 
coding and billing staff. Commenters stated that FQHCs will need to 
spend additional time explaining the charges on the Explanation of 
Benefits (EOB) to Medicare beneficiaries since there could be 
additional charges beyond what the beneficiary typically sees 
associated with a visit. Some commenters stated that using FQHC payment 
G-codes could artificially inflate FQHCs' total gross charges, although 
others stated that some of the financial discrepancies in payment would 
be resolved once the FQHC receives payment. However, many commenters 
stated there would be an administrative burden to a FQHC in the short-
term as it attempts to resolve 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 funding under section 330 of the 
PHS Act are required to maintain charges that are both consistent with 
locally prevailing rates or charges and are also reflective of 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 concerned 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 HCPCS codes support the use of each FQHC 
payment G-code. Commenters stated that services described by codes 
other than evaluation and management (E/M) services also meet the 
definition of a face-to-face visit with a qualifying provider. The 
commenters recommended that for each qualifying visit, the FQHC should 
be able to enter the corresponding FQHC payment G-code to be eligible 
for payment.
    Response: We disagree that the new PPS may limit the scope of FQHC 
services. All services that qualified as a billable visit under the AIR 
payment system 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 visits 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 HCPCS 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 suggested that we develop more G-codes to 
account for other types of services furnished in a FQHC and G-codes 
that address varying patient populations. One commenter suggested 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 population, additional FQHC 
payment G-codes should reflect multiple services, intensity, and cost 
of furnishing services to their complex patient population.
    Response: We stated in the FQHC PPS proposed and final rules that 
our goal for the FQHC PPS is to implement a system in accordance with 
the statute whereby FQHCs are fairly paid for the services they furnish 
to Medicare patients in the least burdensome manner possible, so that 
they may continue to furnish primary and 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 services 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 commenters requested clarification that 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 
service on a

[[Page 67970]]

day subsequent to the day of the visit. These commenters are concerned 
whether under the new billing requirements for the FQHC PPS all 
services are meaningfully included in the encounter payment rate even 
when a component of the service is furnished on a different 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 mental health patient or a patient receiving an 
IPPE or AWV. This may be the same bundle of services that are furnished 
to the patient on a particular day, but is not required to be the same 
services, as the patient may need more, fewer, or a different set of 
services on that particular day.
    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 instructions 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 coinsurance 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 charges or 
the PPS rate, we proposed that we would continue to use FQHC-reported 
charges to determine the amount of coinsurance that should be waived 
for payments based on the FQHC's charge, and that total payment to the 
FQHC, including both Medicare and beneficiary liability, 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 complex and burdensome 
and requested that a simplified system be established.
    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 dollar value of the FQHC's reported line-item charge for the 
preventive service will be subtracted 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 value of the FQHC's 
reported line-item charge for the preventive service, up to the total 
payment amount. Medicare also will pay a FQHC 80 percent of the 
remainder of the full payment amount, and beneficiary coinsurance would 
be assessed at 20 percent of the remainder of the full payment amount. 
If the reported line-item charge for the preventive service equals or 
exceeds the full payment amount, Medicare 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 administrative procedures and billing practices. Most commenters 
appreciated that we are striving for policies that 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 supported that we are striving for a 
waiver of coinsurance calculation that achieves greater simplicity and 
promotes 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 for FQHCs to assess coinsurance at the time services are 
furnished, potentially increase rates of collection, and reduce 
administrative burden. Commenters who supported the revised approach 
requested that we closely monitor how the waiver of coinsurance is 
calculated and determine if further modifications are needed in the 
future. Most commenters preferred 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 the services include a mix of preventive and 
non-preventive services is too complex for the FQHC staff to accurately 
determine the coinsurance at the time services are furnished. 
Commenters suggested that FQHCs would be concerned with overcharging 
the 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 
commenter 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 overcharged 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 the right balance between accuracy and simplicity, and we will 
make adjustment as necessary if problems arise. We also note that, 
under certain circumstances, FQHCs may waive coinsurance amounts for 
Medicare and Medicaid beneficiaries (see for example, section 
1128B(b)(3)(D) of the Act and Sec.  1001.952(k)(2) of the regulations). 
Also, most FQHCs are subject to the statutory and regulatory 
requirements of the Health Center Program (section 330 of the PHS Act; 
42 CFR Part 51c; and 42 CFR 56.201 through 56.604), which, among other 
requirements, mandates 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 incentive for FQHCs to offer 
fewer services at each visit and request patients to return on 
different days for

[[Page 67971]]

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 commenters 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 specific preventive services under section 
4104 of the Affordable Care Act, it was intended to improve access to 
these services, and that requiring Medicare beneficiaries be liable for 
coinsurance when a mixture of preventive and non-preventive services 
are furnished does not remove barriers to these services. Commenters 
also stated that we lack ``any specific statutory authorization to 
waive coinsurance for services provided under the FQHC PPS,'' and 
therefore, CMS is not barred from implementing 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 service is consistent with the regulation under Sec.  
410.152(l), which states that Medicare Part B pays ``100 percent of the 
Medicare payment amount established under the applicable payment 
methodology for the service setting for providers and suppliers of the 
following preventive services.'' Commenters stated that a FQHC is a 
provider of such preventive services and that the FQHC PPS is an 
applicable payment methodology. Commenters surmised that 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 partial coinsurance methodology.
    Response: We disagree with the commenters' interpretation that the 
statutory and regulatory language cited provides us with the authority 
to waive coinsurance for all services when there is a mix of preventive 
and non-preventive services furnished during a FQHC encounter. The 
revised methodology for calculating coinsurance when there is a mix of 
preventive and non-preventive services on the claim was revised in 
response to commenters' concerns that the methodology that was first 
proposed was overly complex and burdensome. We believe that the revised 
methodology is responsive to those concerns, and provides as much 
simplicity as possible while enabling FQHCs to comply with statutory 
requirements for the collection of coinsurance.
    We are retaining Sec.  405.2410(b)(2)(i), Sec.  405.2410(b)(2)(ii), 
and Sec.  405.2462(d) of the Medicare regulations as finalized in 79 FR 
25475 and will use the 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 dollar value of the FQHC's 
reported 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 community 
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 the technical and 
the professional component of preventive services, billing procedures 
and processing of claims for same-day visits. Several commenters 
requested specific examples on calculating coinsurance when the claim 
contains a mixture of preventive and non-preventive services.
    Response: The ``Medicare Benefit Policy Manual, Chapter 13--Rural 
Health Clinic (RHC) and Federally Qualified Health Center (FQHC) 
Services,'' and the ``Medicare Claims Processing Manual, Chapter 9--
Rural Health Clinic (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 Web site at http://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/FQHCPPS/index.html.
    We received some comments that were not related to our specific 
proposals for the FQHC PPS. Although we appreciate the commenters' 
feedback on billing for vaccines under Medicare part D, billing for 
costs relating to language assistance and other enabling services, 
adjustments to the California GAF, FQHC PPS rate risk adjusters, and 
the FQHC PPS implementation date, payment for furnishing services to 
dually eligible Medicare and Medicaid beneficiaries, these topics are 
beyond the scope of our specific proposals that we specified were 
subject to public comment 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 Sec.  411.15(p)(2) and Sec.  489.20(s). In the 
May 2, 2014, interim final rule (79 FR 25462), we updated Sec.  
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 practitioner services from consolidated 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. This statutory 
provision was effective with services furnished on or after January 1, 
2005 and was previously implemented through program instruction (CMS 
Pub 100-04, Medicare Claims Processing Manual, Chapter 6, Section 
20.1.1).
    However, in making this revision, we inadvertently neglected to 
make a conforming change in Sec.  411.15(p)(2), which enumerates the 
individual services that are excluded from the SNF consolidated billing 
provision, as well as in Sec.  489.20(s), which specifies compliance 
with consolidated billing as a requirement of the SNF's Medicare 
provider agreement. Accordingly, we are now rectifying that omission.
    Regarding the technical corrections to parts 411 and 489 of the 
regulations discussed above, we note that we would ordinarily publish a 
notice of proposed rulemaking in the Federal Register to provide a 
period for public comment before revisions in the regulations text 
would take effect; however, we can waive this procedure if we find good 
cause that a notice and comment procedure is impracticable, 
unnecessary, or contrary to the public interest and incorporate a 
statement of the finding and its reasons in the notice issued. We find 
it unnecessary to undertake notice and comment rulemaking in connection 
with these particular revisions, as they merely provide technical 
corrections to the regulations, without making any substantive changes. 
Therefore, 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 Sec.  405.2463(a)(1)(ii). To clarify that TCM 
does not necessarily require a face-to-face visit, we revised this 
section of the regulation for RHCs, but neglected to add the 
appropriate reference for

[[Page 67972]]

FQHCs. Therefore, we are revising Sec.  405.2463(a)(2)(i), so that a 
FQHC visit includes a qualified TCM service.

P. Physician Self-Referral Prohibition: Annual Update to the List of 
CPT/HCPCS Codes

1. General
    Section 1877 of the Act prohibits a physician from referring a 
Medicare beneficiary for certain designated health services (DHS) to an 
entity with which the physician (or a member of the physician's 
immediate family) has a financial relationship, unless an exception 
applies. Section 1877 of the Act also prohibits the DHS entity from 
submitting claims to Medicare or billing the beneficiary or any other 
entity for Medicare DHS that are furnished as a result of a prohibited 
referral.
    Section 1877(h)(6) of the Act and Sec.  411.351 of our regulations 
specify that the following services are DHS:
    <bullet> Clinical laboratory services
    <bullet> Physical therapy services
    <bullet> Occupational therapy services
    <bullet> Outpatient speech-language pathology services
    <bullet> Radiology services
    <bullet> Radiation therapy services and supplies
    <bullet> Durable medical equipment and supplies
    <bullet> Parenteral and enteral nutrients, equipment, and supplies
    <bullet> Prosthetics, orthotics, and prosthetic devices and 
supplies
    <bullet> Home health services
    <bullet> Outpatient prescription drugs
    <bullet> Inpatient and outpatient hospital services
2. Annual Update to the Code List
a. Background
    In Sec.  411.351, we specify that the entire scope of four 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:
    <bullet> Clinical laboratory services
    <bullet> Physical therapy, occupational therapy, and outpatient 
speech-language pathology services
    <bullet> Radiology and certain other imaging services
    <bullet> Radiation therapy services and supplies
    The Code List also identifies those items and services that may 
qualify for either of the following two exceptions to the physician 
self-referral prohibition:
    <bullet> EPO and other dialysis-related drugs furnished in or by an 
ESRD facility (Sec.  411.355(g))
    <bullet> Preventive screening tests, immunizations, or vaccines 
(Sec.  411.355(h))
    The definition of DHS at Sec.  411.351 excludes services that are 
reimbursed by Medicare as part of a composite rate (unless 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). Effective 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 composite rate known as the ESRD prospective 
payment system (ESRD PPS) (75 FR 49030). Accordingly, 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 
Sec.  411.355(g) for EPO and other dialysis-related drugs furnished by 
an ESRD facility.
    Drugs for which there are no injectable equivalents or other forms 
of administration were scheduled to be paid under ESRD PPS beginning 
January 1, 2014 (75 FR 49044). However, on January 3, 2013, Congress 
enacted the American Taxpayer Relief Act of 2012 (ATRA), (Pub. L.112-
240), which will delay payment of these drugs under ESRD PPS until 
January 1, 2016. In the meantime, such drugs furnished in or by an ESRD 
facility are not reimbursed as part of a composite rate and thus, are 
DHS. For purposes of the exception at Sec.  411.355(g), only those 
drugs that are required for the efficacy of dialysis 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 effective January 1, 2015, is 
available on our Web site at http://www.cms.gov/Medicare/Fraud-and-Abuse/PhysicianSelfReferral/List_of_Codes.html.
    Additions and deletions to the Code List conform it to the most 
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 additions and 
deletions to the list of codes used to identify the items and services 
that may qualify for the exception in Sec.  411.355(g) (regarding 
dialysis-related outpatient prescription drugs furnished in or by an 
ESRD facility) and in Sec.  411.355(h) (regarding preventive screening 
tests, immunizations, and vaccines).
    We will consider comments regarding the codes 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 Sec.  411.351.
BILLING CODE 4120-01-P

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BILLING CODE 4120-01-C

Q. Interim Final Revisions to the Electronic Health Record (EHR) 
Incentive Program

1. Statutory Basis
    The American Recovery and Reinvestment Act of 2009 (Pub. L. 111-5) 
(ARRA) amended titles XVIII and XIX of the Act to authorize incentive 
payments to EPs, eligible hospitals, and critical access hospitals 
(CAHs), and Medicare Advantage (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 statutory basis for 
the Medicare incentive payments made to meaningful EHR users. These 
statutory provisions govern EPs, MA organizations (for certain 
qualifying EPs and hospitals that meaningfully use CEHRT), subsection 
(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, subsection (d) hospitals and CAHs that are not 
meaningful users of CEHRT for certain associated reporting 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 period 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 without 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 Final Rule With Comment Period
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 ``Medicare 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 Information 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 implement 2014 Edition CEHRT for an EHR reporting 
period in 2014 due to issues related to 2014 Edition CEHRT availability 
delays 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, respectively. 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 delays in 
2014 Edition CEHRT availability. The final rule also made changes to 
the attestation process to support these flexible options for CEHRT, 
although it did not alter the attestation or hardship exception 
application deadlines for 2014. Therefore, for example, eligible 
hospitals that never successfully attested to meaningful use prior to 
FY 2014 were still required 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 course of the year, we continued 
to urge providers to purchase 2014 Edition CEHRT and not wait until the 
last minute to attest for the 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 associations, multiple 
questions from stakeholders on provider calls, and numerous emails from 
providers and EHR vendors, all expressing confusion and seeking 
clarification about whether they could use the flexible options 
provided under the 2014 CEHRT Flexibility rule. Specifically, providers 
were unsure how they could use the flexible options given that the 
attestation deadlines for both eligible professionals (October 1, 2014) 
and eligible hospitals (July 1, 2014) would have 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 specified 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 compounded by the 
fact that the hardship exception application deadlines for both 
eligible 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 were 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 the 
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 Flexibility rule. We 
also became aware that eligible professionals also faced uncertainty if 
they joined practices that were already using 2011 Edition CEHRT and 
experienced delays in full implementation of 2014 Edition CEHRT. 
Therefore, we understood that eligible professionals were concerned 
that the inability to attest by October 1, 2014 using the flexible 
options under the 2014 CEHRT Flexibility rule would potentially subject 
them to the 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 
options recently finalized under the 2014 CEHRT Flexibility rule for an 
EHR reporting period in 2014, and ensure that providers are not 
potentially subjected to the 2015 payment adjustment under the Medicare 
EHR Incentive Program, we are recognizing a hardship exception under 
the established category of ``extreme and uncontrollable 
circumstances'' under 42 CFR Sec.  495.102(d)(4)(iii) for eligible 
professionals and Sec.  412.64(d)(4)(ii)(B) for eligible hospitals, 
pursuant to the Secretary's discretionary hardship exception authority. 
Under this IFC, we will consider that an extreme and uncontrollable 
circumstance hardship exists for an eligible professional or

[[Page 67977]]

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 availability. Second, the provider must not have 
been able to attest by their attestation deadline in 2014. For example, 
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 
using the flexibility options 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 
criteria and only for the 2015 payment adjustment.
    For CAHs, although we would recognize a hardship exception for CAHs 
under these circumstances, this exception would have little impact on 
CAHs because the hardship exception application deadline for CAHs for 
the 2015 payment adjustment does not occur until November 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 professionals, 
whose attestation and hardship exception application deadlines have 
since passed. However, as explained below, to maximize 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 Sec.  413.70(a)(6) to allow CMS the flexibility to specify an 
alternate hardship exception application submission deadline for 
certain hardship categories other than November 30th.
b. Extension of Hardship Exception Application Deadline to November 30, 
2014 for Eligible Professionals and Eligible Hospitals and Amendments 
to Sec. Sec.  495.102, 412.64, and 413.70.
    Section 495.102(d)(4) provides the categories of hardship 
exceptions for EPs, including insufficient internet access, newly 
practicing EPs, 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 lack 
of need for follow-up care, and certain primary specialties. With the 
exception of the newly practicing EP hardship exception category, the 
EP is required to file a hardship exception application to CMS for the 
remaining hardship categories no later than July 1st of the year before 
the payment adjustment year.
    Similar to eligible professionals, Sec.  412.64(d)(4) provides the 
categories of hardship exceptions for eligible hospitals, which include 
insufficient internet access, new eligible hospitals, and extreme and 
uncontrollable circumstances outside of an eligible hospital's control. 
Under the hardship exception categories for insufficient internet 
access and extreme and uncontrollable circumstances, the eligible 
hospital is required to file a hardship exception application to CMS no 
later than April 1st of the year before the payment adjustment year.
    Similar to eligible hospitals, Sec.  413.70(a)(6) provides the 
categories of hardship exceptions that CAHs could apply for, which 
include insufficient internet access, new CAHs, and extreme and 
uncontrollable circumstances outside of a CAH's control. Under all 
hardship exception categories, the CAH is required to file a hardship 
exception application to CMS no later than November 30th after the 
close of the applicable 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 application 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 Incentive 
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 the hardship exception 
application deadline to November 30, 2014 will allow ample time for 
those eligible 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 
attestation deadline using the flexibility options provided in the 2014 
CEHRT flexibility rule to file an application for the hardship 
exception recognized under this IFC.
    The extension of the hardship exception application 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 hardship 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 deadline, they are not affected in the same 
manner as eligible hospitals and eligible professionals, and are still 
eligible to file a hardship exception application until November 30th 
under any of the categories specified under Sec.  413.70(a)(6).
    Next, to extend the hardship exception application deadline to 
November 30, 2014, for eligible hospitals and eligible professionals, 
we must amend under this IFC the July 1st hardship exception 
application deadline for extreme and uncontrollable circumstances under 
Sec.  495.102(d)(4)(iii) for eligible professionals and the April 1st 
deadline under Sec.  412.64(d)(4)(ii)(B) for eligible hospitals. For 
eligible professionals, the new amendment to Sec.  495.102(d)(4)(iii) 
will include, following the July 1st hardship exception application 
submission deadline specified in the regulation, language that would 
enable CMS to specify a later deadline. For eligible hospitals, the new 
amendment to Sec.  412.64(d)(4)(ii)(B) will include, following the 
April 1st hardship exception application submission deadline specified 
in the regulation, language that would enable CMS to specify a later 
deadline. We are making these regulatory amendments under this IFC to 
allow eligible hospitals and eligible professionals 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 already passed.
    Finally, we note that, as with the circumstances described in this 
IFC that caused us to extend the deadline to November 30, 2014, there 
may be situations in the future that would warrant extending the July 
1st deadline for eligible professionals, the April 1st deadline for 
eligible hospitals, and the November 30th deadline for CAHs. 
Accordingly, 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 regulation text 
for the other hardship exception categories to enable CMS to specify a 
later deadline

[[Page 67978]]

for submission of hardship exception applications.
    Specifically, for eligible professionals, in addition to the 
amendments we cited above for Sec.  495.102(d)(4)(iii) relating to the 
extreme and uncontrollable circumstances hardship exception category, 
we are also amending Sec.  495.102(d)(4)(i) (insufficient internet 
access) and (d)(4)(iv) (multiple locations/lack of face-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 Sec.  412.64(d)(4)(ii)(B) relating to the extreme and 
uncontrollable circumstances hardship exception category, we are also 
amending Sec.  412.64(d)(4)(ii)(A) (lack of internet access) to add 
similar language.
    For CAHs, we are amending Sec.  413.70(a)(6)(ii) to add language 
similar to the language added to the regulation text for eligible 
professionals and eligible hospitals, as discussed above. We believe 
that the flexibility to specify a later hardship exception application 
submission deadline as set forth above will prevent situations such as 
the one addressed under this IFC where, for example, an unforeseen 
circumstance occurred, which could justify a hardship exception, but 
the hardship exception application submission deadline has passed. 
However, we emphasize that we do not intend to exercise this 
flexibility to extend the hardship exception application submission 
deadline frequently. Rather, to maintain the consistency needed for our 
operations, providers should expect to adhere to the dates specified in 
the regulation text and not rely on the possibility of changes to the 
hardship application submission period occurring on a frequent basis.

IV. Collection of Information Requirements

    Under the Paperwork Reduction Act of 1995, we are required to 
provide 60-day notice in the Federal Register and solicit public 
comment before a collection of information requirement is submitted to 
the Office of Management and Budget (OMB) for review and approval. To 
fairly evaluate whether an information collection should be approved by 
OMB, section 3506(c)(2)(A) of the Paperwork Reduction Act of 1995 
requires that we solicit comment on the following issues:
    <bullet> The need for the information collection and its usefulness 
in carrying out the proper functions of our agency.
    <bullet> The accuracy of our estimate of the information collection 
burden.
    <bullet> The quality, utility, and clarity of the information to be 
collected.
    <bullet> Recommendations to minimize the information collection 
burden on the affected public, including automated 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, calculated 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 Visits
    This provision removes the requirement that nonphysician RHC or 
FQHC practitioners be W-2 employees. This action does not require the 
modification 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 Paperwork 
Reduction Act of 1995 (44 U.S.C. 3501 et seq.).
2. ICRs Regarding Access to Identifiable Data 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 under section 
1115A of the Act.
3. ICRs Regarding Local Coverage Determination Process for Clinical 
Diagnostic Laboratory Testing
    The proposed Clinical Diagnostic Laboratory 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 Solicitation of Comments on the Payment Policy 
for Substitute Physician Billing Arrangements
    The proposed rule solicited comment on substitute billing 
arrangements and did not set out any new or revised collection of 
information requirements. Consequently, the Paperwork Reduction Act of 
1995 (44 U.S.C. 3501 et seq.) is not applicable.
5. ICRs Regarding Reports of Payments or Other Transfers of Value and 
Physician Ownership and Investment Interests (Sec.  403.904(c)(8), 
(d)(3), and (g))
    With regard to the following provisions, no PRA-related comments 
were received. The proposed provisions are being adopted without 
change.
    In Sec.  403.904(c)(8), applicable manufacturers and applicable 
group purchasing organizations (GPOs) must report the marketed name and 
therapeutic area or product category of covered drugs, devices, 
biologicals and medical supplies. The amendment has non-measurable 
effect on current burden estimates since the manufacturers and GPOs are 
already required to report the marketed name for drugs and biologicals 
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 submitted to OMB for approval under 
control number 0938-1173 (CMS-10419).
    In Sec.  403.904(d)(3), applicable manufacturers and applicable 
GPOs must report the form of payment or other transfers of value as: 
Cash or cash equivalent, in-kind items or services, stock, stock 
option, or any other ownership investment. The burden associated with 
this provision is the time and effort it will take each applicable 
manufacturer and applicable GPO to revise their reporting system to 
report the form of payment.
    The removal of Sec.  403.904(g) requires that applicable 
manufacturers and applicable GPOs of covered drugs, devices, 
biologicals, and medical supplies report annually to CMS all payments 
or other transfers of value provided as compensation for speaking at a 
continuing education program. The ongoing burden associated with this 
provision is the time and effort it will take each applicable 
manufacturer and applicable GPO to report payments or other transfers 
of value to CMS which were provided to physicians at a continuing 
education program. We estimate that it will take 1.0 hour to report 
payments or other transfers of value to CMS which were provided to 
physician at a continuing education program.
    We estimate that it will take 1.0 hour to report payments or other 
transfers of value to CMS which were provided to physician covered 
recipients as

[[Page 67979]]

compensation for speaking at a continuing education program and 0.5 
hours to revise an applicable manufacturer or applicable GPO's 
reporting system to report the form of payment.
    In deriving these figures, we used the following 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 estimates will be added to 
the existing PRA-related requirements and burden estimates that have 
been approved by OMB under control number 0938-1173 (CMS-10419).
6. ICRs Regarding Physician Payment, Efficiency, and Quality 
Improvements--Physician Quality Reporting System
    With regard to the following provisions, no PRA-related comments 
were received. The proposed provisions are being 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) Individual 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 using 
the group practice reporting option (GPRO). Please note that we are 
grouping group practices using the qualified registry and EHR-based 
reporting mechanisms with the burden estimate for individual eligible 
professionals using the qualified registry and EHR-based reporting 
mechanisms because we believe the criteria for satisfactory reporting 
for group practices using these 2 reporting mechanisms under the GPRO 
are similar to the satisfactory reporting criteria for eligible 
professionals using these reporting mechanisms.
a. Burden Estimate for PQRS Reporting by Individual Eligible 
Professionals: 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 professionals eligible to participate in the 
PQRS in 2012, will be eligible to participate in the PQRS. 
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 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.
---------------------------------------------------------------------------

    \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.
---------------------------------------------------------------------------

    In 2012, 435,871 eligible professionals (36 percent of eligible 
professionals, including those who belonged to group practices that 
reported under the GPRO and 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 Savings Program, or 
Pioneer ACO Model.\32\ We expect to see a significant increase in 
participation in reporting for 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 percent participation 
rate in 2015. We still believe that a 14 percent increase in 
participation from 2012 is reasonable in 2015. Therefore, we estimate 
that 50 percent of eligible professionals (or approximately 600,000 
eligible professionals) will report quality measures data for purposes 
of the 2017 PQRS payment adjustment.
---------------------------------------------------------------------------

    \32\ Id. at XV.
---------------------------------------------------------------------------

    With respect to the PQRS, the burden associated with the 
requirements of this voluntary reporting initiative is the time and 
effort associated with 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 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 quality 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 that a billing clerk will handle the administrative 
duties associated with participating in the PQRS. According to 
information published by the Bureau of Labor Statistics, available at 
http://www.bls.gov/oes/current/oes433021.htm, the mean hourly wage for 
a billing clerk is approximately $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. According to information 
published by the Bureau of Labor Statistics, available at http://www.bls.gov/oes/current/oes151121.htm, the mean hourly wage for a 
computer analyst is approximately $82.00/hour. Therefore, for purposes 
of reporting on quality measures, we estimate an average labor cost of 
$82.00/hour.
    Please note that, in assessing PQRS-specific burden 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 the wage rates in those estimates.
    For individual eligible professionals, the burden associated with 
the requirements of this reporting initiative is the time and effort 
associated 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 report the eligible professional's measures. We believe it is 
difficult to accurately quantify the burden because eligible 
professionals may have different processes for integrating 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 patients and the 
services he or she furnishes to them, and incorporate the use of 
quality data codes into the office work flows is expected to vary along 
with the number of measures that are potentially applicable to a given 
professional's practice. Since eligible professionals are generally 
required to report on at least 9 measures covering at least 3 National 
Quality Strategy domains criteria for

[[Page 67980]]

satisfactory reporting (or, in lieu of satisfactory reporting, 
satisfactory participation in a QCDR) for the 2017 PQRS payment 
adjustment, we assume that each eligible professional reports on an 
average of 9 measures for this burden 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 or measures 
groups, and incorporate reporting of the selected 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 society, we estimate it will take an 
eligible professional's billing clerk up to 2 hours to review this 
list, review the reporting options, and select a reporting option and 
measures on which to report. If an eligible professional has received 
training, then we believe this would take less time. CMS believes 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 group 
into the office work flows. Therefore, we believe that the start-up 
cost for an eligible professional to report PQRS quality measures data 
is 5 hours x $32/hour = $160.
    We continue to expect the ongoing costs associated 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 professionals and group practices participating in the GPRO 
according to the reporting mechanism used.
b. Burden Estimate for PQRS Reporting by Individual Eligible 
Professionals 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-based reporting mechanism. 
According to the 2012 Reporting Experience, 248,206 eligible 
professionals participated in the PQRS using the claims-based reporting 
mechanism in 2012.\33\ Preliminary estimates show that 252,567 eligible 
professionals participated in the PQRS using the claims-based reporting 
mechanism in 2013.\34\
---------------------------------------------------------------------------

    \33\ Id. at xvi. See Figure 4.
    \34\ Id.
---------------------------------------------------------------------------

    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. While these eligible professionals 
continue to participate in the PQRS, these eligible professionals have 
started to shift towards the use of other 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 
the Pioneer ACO Model), registry, or the EHR-based 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 professionals 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 include the appropriate QDCs on the claims they 
submit for payment. The PQRS 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 new 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.
    We estimate the cost for an eligible professional 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 Physician 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 data 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 perform 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 
for more complicated cases and/or measures, with the cost for the 
median practice being $2.40. To report 9 measures, 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 requirement will also 
vary along with the volume of claims on which quality data is reported. 
In previous years, when we required reporting on 80 percent of eligible 
cases for claims based reporting, we found that on average, the median 
number of reporting instances for each 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 measure for 6 reporting instances. The 
actual number of cases on which an eligible professional or group 
practice is required to report quality measures data will vary, 
however, with the eligible professional's or group practice's patient 
population and the types of measures on which the eligible professional 
or group practice chooses to report (each measure's specifications 
includes a required reporting frequency).
    Based on these assumptions, we estimate that the total annual 
reporting burden per individual eligible professional associated with 
claims 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), with the burden to the 
median practice being

[[Page 67981]]

94.5 minutes (1.75 minutes per measure x 9 measures x 6 cases). We 
estimate the total annual reporting cost per eligible professional or 
eligible professional in a group practice associated with claims based 
reporting 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 practice 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
    In 2011, approximately 50,215 (or 16 percent) of the 320,422 
eligible professionals participating in PQRS used the qualified 
registry-based reporting mechanism. According to the 2012 Reporting 
Experience, 36,473 eligible professionals reported individual measures 
via the registry-based reporting mechanism, and 10,478 eligible 
professionals 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. 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.
---------------------------------------------------------------------------

    \35\ Id. at xvi. See Figure 4.
---------------------------------------------------------------------------

    We believe that the rest of the eligible professionals not 
participating in other PQRS reporting mechanisms will use either the 
registry or QCDR reporting mechanisms for the following reasons:
    <bullet> The PQRS measures set is moving away from use of claims-
based measures and moving towards the use of registry-based measures.
    <bullet> We believe the number of QCDR vendors will increase as the 
QCDR reporting mechanism evolves.
    Therefore, based on these assumptions, we expect to see a 
significant jump from 47,000 eligible professionals to approximately 
165,000 eligible professionals using either the registry-based 
reporting mechanism or QCDR in 2015. We believe the majority of these 
eligible professionals will participate in the PQRS using 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 data to a qualified registry as eligible 
professionals and group practices opting for qualified registry based 
reporting or use of a QCDR will more than likely already be reporting 
data to the qualified registry for other purposes and the qualified 
registry will merely be repackaging the data for use in the PQRS. 
Little, if 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 registry or QCDR to submit quality 
measures results and numerator and denominator data on quality measures 
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 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 Individual Eligible 
Professionals and Group Practices: 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 eligible professionals 
participating in PQRS used the EHR-based reporting mechanism. In 2012 
there was a sharp increase in reporting via the EHR-based reporting 
mechanism. Specifically, according to the 2012 Reporting Experience, in 
2012, 19,817 eligible professionals submitted quality data for the PQRS 
through a qualified EHR.\36\
---------------------------------------------------------------------------

    \36\ Id. at xv.
---------------------------------------------------------------------------

    We believe the number 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 programs encouraging the use of 
an EHR, such as the EHR Incentive Program. In particular, we believe 
eligible professionals will transition from using the claims-based to 
the EHR-based reporting mechanism. To account for this anticipated 
increase, we continue to estimate that approximately 50,000 eligible 
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 EHR-based reporting, which includes EHR reporting via a direct 
EHR product and an EHR data submission vendor's product, 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-designated 
clinical data warehouse.
    For EHR based reporting for the PQRS, the individual eligible 
professional or group practice may either submit the quality measures 
data directly to CMS from their EHR or utilize an EHR data submission 
vendor to submit the data to CMS on the eligible professional's or 
group practice's behalf. To submit data to CMS directly from their EHR, 
the eligible professional or eligible professional in a group practice 
must have access to a CMS specified identity management system, such as 
IACS, which we believe takes less than 1 hour to obtain. Once an 
eligible professional or eligible professional 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 necessary 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 the eligible professional 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 eligible 
professional's or group practice's EHR.
e. Burden Estimate for PQRS Reporting by Group 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 2012 Reporting Experience, 66 
practices participated in

[[Page 67982]]

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 approximately 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 approximately 135,000 
eligible professionals) will participate in the PQRS using the GPRO web 
interface in 2015.
---------------------------------------------------------------------------

    \37\ Id. at xv.
    \38\ Id. at xvi.
    \39\ Id. at 18.
---------------------------------------------------------------------------

    With respect to the process for group practices to be treated as 
satisfactorily submitting quality measures data under the PQRS, group 
practices interested in participating in the PQRS through the GPRO must 
complete a self-nomination process similar to the self-nomination 
process required of qualified registries. However, since a group 
practice using the GPRO web interface would not need to determine which 
measures to report under PQRS, we believe that the self-nomination 
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 participate 
as a group rather than individually and an additional 2 hours per group 
practice to draft the letter of intent for self-nomination, gather the 
requested TIN and NPI information, and provide this requested 
information. It is estimated that each self-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, assuming the total burden hours per group practice 
associated with the group practice self-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 practice reporting 
requirements under the GPRO is the time and effort associated with the 
group practice 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 and 
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 expiration date of July 31, 2015, for use in the PGP, MCMP, and 
EHR demonstrations. As the GPRO was only recently implemented in 2010, 
it is difficult to determine the 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 participating in the 
GPRO as we use for group practices participating in the PGP, MCMP, and 
EHR demonstrations. Since these 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 burden 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. Therefore, the total 
estimated annual cost per group practice is estimated to be 
approximately $6,478.
7. ICRs Regarding the Medicare Shared Savings Program
    Section 3022 of the Affordable Care Act exempts any collection of 
information associated with the Medicare Shared Savings Program from 
the requirements of the Paperwork Reduction Act of 1995 (44 U.S.C. 3501 
et seq.).
8. ICRs Regarding Interim Revisions to the Electronic Health Record 
(EHR) Incentive Program
    This rule does not impose new or alter existing reporting, 
recordkeeping, 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 Uncontrollable Circumstances Hardship 
Exception
    With regard to the hardship application, this rule will not impose 
any new or revised reporting, recordkeeping, or third-party disclosure 
requirements and therefore, does not require additional OMB review 
under the authority of the Paperwork Reduction 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.
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C. Submission of PRA-Related Comments

    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.

[[Page 67984]]

    To obtain copies of the supporting statement and any related forms 
for the paperwork collections referenced above, access CMS' Web site at 
http://www.cms.hhs.gov/PaperworkReductionActof1995; email your request, 
including your address, phone number, OMB number, and CMS document 
identifier, to <a href="/cdn-cgi/l/email-protection#653504150017120a170e250608164b0d0d164b020a13"><span class="__cf_email__" data-cfemail="beeedfcedbccc9d1ccd5feddd3cd90d6d6cd90d9d1c8">[email protected]</span></a>; 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 OMB 
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, Email: 
<a href="/cdn-cgi/l/email-protection#4906001b08163a3c2b24203a3a2026270926242b672c2639672e263f"><span class="__cf_email__" data-cfemail="602f2932213f1315020d091313090f0e200f0d024e050f104e070f16">[email protected]</span></a>.
    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 this preamble, 
and, when we proceed with a subsequent document, we will respond to the 
comments in the preamble to that document.

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 subjects 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 incorporates 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 procedures, 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 emerging 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. 
The HCPCS, including both Level I and Level II codes, is similarly 
updated annually on a CY basis. Annual coding changes are not available 
to the public until the Fall immediately preceding the annual January 
update of the PFS. Because of the timing of the release of these new 
and revised codes, it is impracticable for us to provide prior notice 
and solicit comment on these codes and the RVUs assigned to them in 
advance of publication of the final rule that implements the PFS. Yet, 
it is imperative that these coding changes be accounted for and 
recognized timely under the PFS for payment because services 
represented by these codes will be furnished to Medicare beneficiaries 
by physicians and practitioners during the CY in which they become 
effective. Moreover, regulations implementing HIPAA (42 CFR parts 160 
and 162) require that the HCPCS be used to report health care services, 
including services 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 codes 
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 which we received 
RUC recommendations for only one component (work or PE) but not both. 
By reviewing 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 
services. We are also able to determine, on an interim final basis, 
whether the codes will be subject 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 these 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 until 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 establish RVUs 
on an interim final basis beginning with rulemaking for CY 2017. 
However, for the reasons previously outlined in this section, we find 
good cause to waive the notice of proposed rulemaking 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 providing a 60-day public comment period.
    Section II.E. of this final rule with comment period discusses 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 revisions prior to publication of 
this final rule with comment period. We believe it is in the public 
interest to implement the revised RVUs for the codes that were 
identified as misvalued, and that have been reviewed 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 values for these misvalued 
codes would not only perpetuate the known misvaluation for these 
services, it would also perpetuate distortion in the payment for other 
services under the PFS. Implementing the 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 beginning with

[[Page 67985]]

rulemaking for CY 2017. However, for the reasons previously described, 
we find good cause 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.

B. FQHC PPS Rates and Adjustments

    We ordinarily publish a notice of proposed rulemaking in the 
Federal Register and invite public comment on the proposed rule before 
publishing a final rule that responds to comments and sets forth final 
regulations that generally take effect at least 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 incorporates 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 
Sec.  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 practitioner services from consolidated 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 inadvertently neglected to 
make a conforming change in Sec.  411.15(p)(2), which enumerates the 
individual services that are excluded from the SNF consolidated billing 
provision, as well as in Sec.  489.20(s), which specifies compliance 
with consolidated billing as a requirement of the SNF's Medicare 
provider agreement. Accordingly, we are now rectifying that omission in 
this final rule with comment period, by making a conforming technical 
revision in Sec.  411.15(p)(2) and Sec.  489.20(s).
    These particular revisions merely provide technical corrections to 
the regulations, without making any substantive changes. Therefore, 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 Health 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 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 subjects 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 incorporates a 
statement of the finding and its reasons in the rule issued.
    With regard to the interim revisions to the Electronic Health 
Record (EHR) Incentive Program, we find good cause to waive the notice-
and-comment procedure as contrary to the public interest. We believe 
that providing notice and a comment period would prevent us from 
providing relief from the circumstances outlined in section III.Q. A 
delay would interfere with the ability of eligible professionals and 
eligible hospitals to request a hardship exception for the extreme and 
uncontrollable circumstances specified 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 subject providers to the 2015 payment adjustment under the 
Medicare EHR Incentive Program and potentially 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 Incentive Program and to establish these revisions 
on an interim final basis. We are providing 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 delay in effective 
date can be waived, however, if the agency finds for good cause that 
the delay is impracticable, unnecessary, or contrary to the public 
interest, and the agency incorporates a statement of the findings 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 it would be contrary to the public interest 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 revisions relieve a 
restriction.
    The IFC recognizes a hardship exception based on extreme and 
uncontrollable circumstances, which could potentially provide relief 
from the application of the 2015 payment adjustment under the Medicare 
EHR Incentive Program to certain providers. This IFC would also relieve 
a restriction 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 30th 
extended hardship exception application submission period specified in 
this IFC, given that their hardship exception application submission 
deadlines have since passed. 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 restriction by changing 
the deadlines by which providers must apply for hardship exceptions. 
These provisions will be effective on October 31, 2014.

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 rule with comment period also is necessary to make 
changes to Part B payment policy for clinical diagnostic lab tests and 
other Part B related policies. This rule also implements aspects of the 
data collection 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 (September 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 (March 22, 
1995; Pub. L. 104-4), Executive Order 13132 on Federalism (August 4, 
1999) and the Congressional 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 impacts, and equity). A 
regulatory impact analysis (RIA) must be prepared for major rules with 
economically significant effects

[[Page 67986]]

($100 million or more in any 1 year). We estimate, as discussed below 
in this section, that the PFS provisions included in this final rule 
with comment period will redistribute more than $100 million in 1 year. 
Therefore, we estimate that this rulemaking is ``economically 
significant'' as measured by the $100 million threshold, and hence also 
a major rule under the Congressional Review Act. Accordingly, we have 
prepared a RIA that, to the best of our ability, presents the costs and 
benefits of the rulemaking. The RFA requires agencies to analyze 
options for regulatory relief of small entities. For purposes of the 
RFA, small entities include small businesses, nonprofit organizations, 
and small governmental jurisdictions. Most hospitals, practitioners and 
most other providers and suppliers are small entities, either by 
nonprofit status or by having annual revenues that qualify for small 
business status under the Small Business Administration standards. (For 
details see the SBA's Web site at http://www.sba.gov/content/table-small-business-size-standards (refer to the 620000 series)). 
Individuals and States are not included in the definition of a small 
entity.
    The RFA requires that we analyze regulatory options for small 
businesses and other entities. We prepare a regulatory flexibility 
analysis unless we certify that a rule would not have a significant 
economic impact on a substantial number of small entities. The analysis 
must include a justification concerning the reason action is being 
taken, the kinds and number of small entities the rule affects, and an 
explanation of any meaningful options that achieve the objectives with 
less significant adverse economic impact on the small entities.
    Approximately 95 percent of practitioners, other 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 receive Medicare payment under the PFS. 
Because many of the affected entities are small entities, the analysis 
and discussion provided in this section as well as elsewhere in this 
final rule with comment period is intended to comply with the RFA 
requirements.
    In addition, section 1102(b) of the 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. This analysis must conform 
to the provisions of section 604 of the RFA. For purposes of section 
1102(b) of the Act, we define a small rural hospital as a hospital that 
is located outside of a Metropolitan Statistical Area for Medicare 
payment regulations and 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 with comment period 
would not have a significant impact on the operations of a substantial 
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 impose no mandates on state, local, or tribal governments 
or on the private sector.
    Executive Order 13132 establishes certain requirements that an 
agency must meet when it promulgates a proposed rule (and subsequent 
final rule) that imposes substantial direct requirement costs on State 
and local governments, preempts State law, or otherwise has Federalism 
implications. Since this regulation does not impose any costs on State 
or local governments, the requirements of Executive Order 13132 are not 
applicable.
    We have prepared the following analysis, which together with the 
information provided in the rest of this preamble, meets all assessment 
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 the 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 regulations, payments, or payment policies to ensure 
that our payment systems reflect changes in medical 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, overlap, or conflict with this 
final rule with comment period. The relevant sections of this final 
rule with comment period contain a description of significant 
alternatives if applicable.

C. Relative Value Unit (RVU) Impacts

1. Resource-Based Work, PE, and Malpractice RVUs
    Section 1848(c)(2)(B)(ii)(II) of the Act requires that increases 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 these changes. If this threshold is exceeded, we 
make adjustments to preserve budget neutrality.
    Our estimates of changes in Medicare revenues for PFS services 
compare payment rates for CY 2014 with payment rates for CY 2015 using 
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 individual physician could vary 
from the average and would depend on the mix of services the physician 
furnishes. The average change in total revenues would be less than the 
impact displayed here because physicians furnish services to both 
Medicare and non-Medicare patients and specialties may receive 
substantial Medicare revenues for services that are not paid under the 
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 the effect of the April 
2015 conversion factor changes under current law. The annual update to 
the PFS conversion factor is calculated based on a statutory formula 
that measures actual versus allowed or ``target'' expenditures, and 
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 withheld 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 expenditures 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 law, 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.

[[Page 67987]]

Although the 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 Medicare 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 physician update for CY 2015 on our Web site at 
http://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/SustainableGRatesConFact/index.html?redirect=/SustainableGRatesConFact/
.
    Tables 93 shows the payment impact on PFS services. 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 different 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 information represented in 
Table 93:
    <bullet> Column A (Specialty): The Medicare specialty code as 
reflected in our physician/supplier enrollment files.
    <bullet> 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 include coinsurance and deductibles (which are the 
financial responsibility of the beneficiary). These amounts have been 
summed across all services furnished by physicians, practitioners, and 
suppliers within a specialty to arrive at the total allowed charges for 
the specialty.
    <bullet> Column C (Impact of Work RVU Changes): This column shows 
the estimated CY 2015 impact on total allowed charges of the changes in 
the work RVUs, including the impact of changes due to new, revised, and 
misvalued codes.
    <bullet> Column D (Impact of PE RVU Changes): This column shows the 
estimated CY 2015 impact on total allowed charges of the changes 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.
    <bullet> Column E (Impact of Malpractice (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.
    <bullet> Column F (Cumulative Impact): This column 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 
columns C, D, and E due to rounding.
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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, effective 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 this final rule with comment period.) Payment for this 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 medicine, and geriatrics. The 
most widespread specialty impacts in PE RVUs are generally related 
implementing the RUC recommendation regarding the film-to-digital 
migration of imaging inputs, which primarily affects portable x-ray 
suppliers, diagnostic testing facilities, and interventional radiology. 
Other impacts result from 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 attributable to the changes 
made as part of the statutorily required review of MP RVUs every five 
years as described in section II.C of this final rule with comment 
period. Of particular 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 resulted 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.

[[Page 67990]]

d. Combined Impact
    Column F of Table 93 displays the estimated CY 2015 combined impact 
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, 2015, applicable under the current statute.
    Table 94 (Impact of Final rule with comment 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 the 
sake of illustration from among the most commonly furnished by a broad 
spectrum of specialties. 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 rule with 
comment period.
BILLING CODE 4120-01-P

[[Page 67991]]

[GRAPHIC] [TIFF OMITTED] TR13NO14.167


[[Page 67992]]


[GRAPHIC] [TIFF OMITTED] TR13NO14.168

BILLING CODE 4120-01-C

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 Medicare telehealth services. Although we expect these changes to 
increase access to care in

[[Page 67993]]

rural 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 year). For CY 2015, we are not making any 
revisions related to the data or the methodologies 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 are 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 Sec.  414.610(c)(1)(ii) and Sec.  414.610(c)(5)(ii) to conform the 
regulations to these self-implementing statutory provisions.
    The geographic designations for approximately 92.02 percent of ZIP 
codes would be unchanged if we adopt OMB's revised statistical area 
delineations and the updated RUCA codes. There are more ZIP codes that 
would change from rural to urban (3,038 or 7.08 percent) than 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 RUCA 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. 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 delineations and the updated RUCA codes. We estimate that the 
adoption of the revised OMB delineations and the updated 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 for services furnished 
``incident to'' RHC and FQHC visits will provide RHCs and FQHCs with 
greater flexibility 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 Center for Medicare and Medicaid 
Models
    Given that, in general, participants in Innovation 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 will vary by project, and thus 
cannot be laid out with specificity here. We do, however, expect the 
costs to be covered by payments associated with the model test.
5. Local Coverage Determination Process for Clinical Diagnostic 
Laboratory Tests
    The Local Coverage Determination Process for Clinical Diagnostic 
Laboratory Tests will not be finalized. Therefore, there is no impact 
to CY 2015 physician payments under the PFS.
6. Private Contracting/Opt Out
    We corrected cross-references and outdated terminology in the 
regulations that we inadvertently neglected to revise, and changed the 
appeals process used for certain appeals relating to opt-out private 
contracting. We anticipate no or minimal impact as a result of these 
corrections.
7. Payment Policy for Locum Tenens Physicians
    We did not issue any new or revised requirements. There is no 
impact.
8. Reports of Payments or Other Transfers 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 Web site because 
we are not collecting any new information specifically for the 
Physician Compare Web site. The information derived for Physician 
Compare comes from other programs that already collect data, including 
but not limited to the Physician Quality Reporting System (PQRS) and 
the Medicare Shared Savings 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 assume that 1.2 million eligible professionals, the 
same number of eligible professionals eligible to participate in the 
PQRS in 2012, will be eligible to participate in the PQRS. Since all 
eligible professionals are subject to the 2017 PQRS payment adjustment, 
we estimate that 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 meeting the criteria for satisfactory reporting 
(or, in lieu of satisfactory reporting, satisfactory participation in a 
QCDR) for the 2017 PQRS payment adjustment.
---------------------------------------------------------------------------

    \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.
---------------------------------------------------------------------------

    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

[[Page 67994]]

adjustment. In 2012, 435,871 eligible professionals (36 percent) 
eligible professionals (including those who belonged to group practices 
that reported under the GPRO and 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 Savings Program, 
or Pioneer ACO Model.\41\ We expect to see a significant increase in 
participation in reporting for the PQRS in 2015 than 2012 as eligible 
professionals were not subject to a PQRS payment adjustment in 2012. 
Last year (78 FR 74793), we estimated that we would see a 50 percent 
participation rate in 2015. We still believe that a 14 percent increase 
in participation from 2012 is reasonable in 2015. Therefore, we 
estimate that 50 percent of eligible professionals (or approximately 
600,000 eligible professionals) will report quality measures data for 
purposes of the 2017 PQRS payment adjustment.
---------------------------------------------------------------------------

    \41\ Id. at XV.
---------------------------------------------------------------------------

    For participation in the PQRS using the 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-based reporting mechanism. 
According to the 2012 Reporting Experience, 248,206 eligible 
professionals participated in the PQRS using the claims-based reporting 
mechanism in 2012.\42\ Preliminary estimates show that 252,567 eligible 
professionals participated in the PQRS using the claims-based reporting 
mechanism in 2013.\43\ According to the historical data cited above, 
although the claims-based reporting mechanism is still the most widely-
used reporting 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 other 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 EHR-based reporting mechanisms. For purposes of this 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 participate in the PQRS using the claims-
based reporting mechanism.
---------------------------------------------------------------------------

    \42\ Id. at xvi. See Figure 4.
    \43\ Id.
---------------------------------------------------------------------------

    For participation in the PQRS using a qualified registry or QCDR, 
in 2011, approximately 50,215 (or 16 percent) of the 320,422 eligible 
professionals participating in PQRS used the qualified registry-based 
reporting mechanism. According to the 2012 Reporting Experience, 36,473 
eligible professionals reported individual measures via the registry-
based reporting mechanism, and 10,478 eligible professionals 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 professional may 
participate in the PQRS via a QCDR. We believe that the rest of the 
eligible professionals 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 
registry-based measures; or (2) we believe the number of QCDR vendors 
will increase as the QCDR reporting mechanism 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 claims, 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 the majority of these eligible professionals will participate 
in the PQRS using a QCDR, as we presume QCDRs will be larger entities 
with more members.
---------------------------------------------------------------------------

    \44\ Id. at xvi. See Figure 4.
---------------------------------------------------------------------------

    For participation in the PQRS 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 eligible 
professionals participating in PQRS used the EHR-based reporting 
mechanism. 2012 saw a sharp increase in reporting via the EHR-based 
reporting 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 number 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 programs encouraging use of an EHR, such as the EHR 
Incentive Program. In particular, we believe eligible professionals 
will transition from using the claims-based to the EHR-based reporting 
mechanisms. To account for this anticipated increase, we continue to 
estimate that approximately 50,000 eligible 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.
---------------------------------------------------------------------------

    \45\ Id. at xv.
---------------------------------------------------------------------------

    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 eligible professionals (or approximately 140,000 eligible 
professionals).\48\ Since it seems that roughly 200 group practices 
participated in the GPRO in 2011 and 2012, based on these numbers, we 
will assume that 200 group practices (accounting for approximately 
135,000 eligible professionals) will participate in the PQRS using the 
GPRO web interface in 2015.
---------------------------------------------------------------------------

    \46\ Id. at xv.
    \47\ Id. at xvi.
    \48\ Id. at 18.
---------------------------------------------------------------------------

    Please note that, while we are finalizing the reporting of CAHPS 
survey measures using a CMS-certified survey vendor, we are not 
including this reporting mechanism in this impact statement as we 
believe that eligible professionals 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 the requirements of this 
voluntary reporting initiative is the time and effort associated with 
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 selected reporting 
option.

[[Page 67995]]

    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 quality 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 assume that a billing clerk will handle the 
administrative duties associated with participating in the PQRS. 
According to information published by the Bureau of Labor 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 purposes 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, available 
at http://www.bls.gov/oes/2013/may/oes151121.htm, the mean hourly wage 
for a computer analyst is approximately $41.00/hour. Therefore, 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 and overhead associated with 
labor in addition to the hourly wage costs described above, we are 
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 
associated 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 report the eligible professional's measures. We believe it is 
difficult to accurately quantify the burden because eligible 
professionals may have different processes for integrating 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 patients and the 
services he or she furnishes to them, and incorporate the use of 
quality data codes into the office work flows is expected to vary along 
with the number of measures that are potentially applicable to a given 
professional's practice. Since eligible professionals are generally 
required to report on at least 9 measures covering at least 3 National 
Quality Strategy domains criteria for satisfactory reporting (or, in 
lieu of satisfactory reporting, satisfactory participation 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 burden 
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 or measures 
groups, and incorporate reporting of the selected 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 society, we estimate it will take an 
eligible professional's billing clerk up to 2 hours to review this 
list, review the reporting options, and select a reporting option and 
measures on which to report. If an eligible professional has received 
training, then we believe this would take less time. We believe 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 group into 
the office work flows. Therefore, we believe that the start-up cost for 
an eligible professional to report PQRS quality 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 professionals and group practices 
participating in the GPRO according to the reporting mechanism used.
(b) Burden Estimate for PQRS Reporting by Individual 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 include the appropriate QDCs on the claims they 
submit for payment. The PQRS will collects QDCs as additional 
(optional) line items on the existing HIPAA transaction 837-P and/or 
CMS Form 1500 (OCN: 0938-0999). We do not anticipate any new forms and 
or any modifications 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 professional 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 Physician 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 data 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 perform 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 
about $16.40 in labor time for more complicated cases and/or measures, 
with the cost for the median practice being $2.40. To report 9 
measures, using an average labor cost of $82/hour, we estimated 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 requirement will also 
vary along with the volume of claims on which quality data is reported. 
In previous years, when we required reporting on 80 percent of eligible 
cases for claims-based reporting, we found that on average, the median 
number of reporting instances for each 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 will assume that 
an eligible professional or eligible professional in a group practice 
will need to report each selected measure for

[[Page 67996]]

6 reporting instances. The actual number of cases on which an eligible 
professional or group practice is required to report quality measures 
data will vary, however, with the eligible professional's or group 
practice's patient population and the types of measures on which the 
eligible professional or group practice chooses to report (each 
measure's specifications includes a required reporting frequency).
    Based on the assumptions discussed previously, we estimate the 
total annual reporting burden per individual eligible professional 
associated with claims-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), 
with the burden to the median practice being 94.5 minutes (1.75 minutes 
per measure x 9 measures x 6 cases). We estimate the total annual 
reporting cost per eligible professional or eligible professional in a 
group practice associated with claims-based reporting 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 practice 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 data to a qualified registry as eligible 
professionals and group practices opting for qualified registry-based 
reporting or use of a QCDR will more than likely already be reporting 
data to the qualified registry for other purposes and the qualified 
registry will merely be re-packaging the data for use in the PQRS. 
Little, if 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 registry or QCDR to submit quality 
measures results and numerator and denominator data on quality measures 
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 professional 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 annual 
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 the 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 product, 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 designated 
clinical data warehouse.
    For EHR-based reporting for the PQRS, the individual eligible 
professional 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 
eligible professional or eligible professional in a group practice must 
have access to our specified identity management system, such as IACS, 
which we believe takes less than 1 hour to obtain. Once an eligible 
professional or eligible professional in a group practice has an 
account for our specified identity management system, he or she will 
need to extract the necessary clinical data from his or her EHR, and 
submit the necessary data to the our 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 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 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 eligible professional's or 
group practice's EHR.
(e) Burden Estimate for PQRS Reporting by Group Practices Using the 
GPRO Web Interface
    With respect to the process for group practices to be treated as 
satisfactorily submitting quality measures data under the PQRS, group 
practices interested in participating in the PQRS through the group 
practice reporting option (GPRO) must complete a self-nomination 
process similar to the self-nomination process required of qualified 
registries. However, since a group practice using the GPRO web 
interface would not need to determine which measures to report under 
PQRS, we believe that the self-nomination 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 participate as a group rather than individually 
and an additional 2 hours per group practice to draft the letter of 
intent for self-nomination, gather the requested TIN and NPI 
information, and provide this requested information. It is estimated 
that each self-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, assuming the 
total burden hours per group practice associated with the group 
practice self-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 practice reporting 
requirements under the GPRO is the time and effort associated with the 
group practice 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 and 
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--Form 10136, 
with an expiration date of December 31, 2011 for use in the PGP, MCMP, 
and EHR demonstrations. As the GPRO was only

[[Page 67997]]

recently implemented in 2010, it is difficult to determine the 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 participating in the GPRO as we use for group practices 
participating in the PGP, MCMP, and EHR demonstrations. Since these 
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 
burden 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. 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 reporting periods of 
which occur in CY 2015.

 Table 95--Summary of Burden Estimates for Eligible Professionals and/or
   Group Practices Using the Claims, Qualified Registry, and EHR-Based
        Reporting Mechanisms for the 2017 PQRS Payment Adjustment
------------------------------------------------------------------------
                                      Minimum burden     Maximum burden
                                         estimate           estimate
------------------------------------------------------------------------
Estimated Annual Burden Hours for           1,306,025          3,948,920
 Claims-based Reporting (for
 individual eligible professionals
 only)............................
Estimated Annual Burden Hours for           1,333,695          1,333,695
 Qualified registry-based or QCDR-
 based Reporting..................
Estimated Annual Burden Hours for             450,000            450,000
 EHR-based Reporting..............
Estimated Total Annual Burden               3,089,720          5,732,615
 Hours for Eligible Professionals
 or Eligible Professionals in a
 Group Practice...................
Estimated Cost for Claims-based          $107,090,000       $323,900,000
 Reporting (for individual
 eligible professionals only).....
Estimated Cost for Qualified             $109,362,000       $109,362,000
 registry-based Reporting.........
Estimated Cost for EHR-based              $32,800,000        $32,800,000
 Reporting........................
Estimated Total Annual Cost for          $249,252,000       $466,062,000
 Eligible Professionals or
 Eligible Professionals in a Group
 Practice.........................
------------------------------------------------------------------------


     Table 96--Estimated Costs of Group Practices Using the GPRO Web
     Interface To Participate in the PQRS for the 2017 PQRS Payment
                               Adjustment
------------------------------------------------------------------------
                                                         Maximum burden
                                                            estimate
------------------------------------------------------------------------
Estimated # of Participating Group Practices.........                200
Estimated # of Burden Hours Per Group Practice to                      6
 Self-Nominate to Participate in PQRS and the
 Electronic Prescribing Incentive Program Under the
 Group Practice Reporting Option.....................
Estimated # of Burden Hours Per Group Practice to                     79
 Report Quality Measures.............................
Estimated Total Annual Burden Hours Per Group                         85
 Practice............................................
Estimated Total Annual Burden Hours for Group                     17,000
 Practices...........................................
Estimated Cost Per Group Practice to Self-Nominate to               $192
 Participate in PQRS for the Group Practice Reporting
 Option..............................................
Estimated Cost Per Group Practice to Report Quality               $6,478
 Measures............................................
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 
modifications 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 being 
adopted in this final rule with comment period do not increase the 
quality reporting burden for ACOs participating in the Shared Savings 
Program and their ACO participants and ACO providers/suppliers, there 
is no impact for these policies.
13. Value-Based Payment Modifier and the Physician Feedback Program
    Section 1848(p) of the Act requires that we establish a VM and 
apply it to specific physicians and groups of physicians the Secretary 
determines appropriate starting January 1, 2015 and to all physicians 
and groups of physicians 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 physicians equal the reduced payments to low 
performing physicians and groups of physicians.
    The changes to the VM in section III.N of this 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 the 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 professionals. We identify a group of physicians as a single 
taxpayer identification 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

[[Page 67998]]

CY 2013 as the performance period for the VM that will be applied to 
payments during CY 2015 (77 FR 69314). We also finalized 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 the Comprehensive Primary Care Initiative, or other 
similar Innovation Center or CMS initiatives (77 FR 69313).
    We finalized policies to determine the amount 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 the PQRS as a group and 
report at least one measure or (b) elect the PQRS Administrative Claims 
option as a group. Category 2 includes groups that do not fall within 
either of the two subcategories (a) or (b) of Category 1. Groups within 
Category 1 may elect to have their VM for CY 2015 calculated using the 
quality-tiering methodology, which could result in an upward, neutral, 
or downward adjustment amount. The VM for groups of physicians in 
Category 1 that do not elect-quality tiering is 0.0 percent, meaning 
that these groups will not receive 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 categories 
depending upon whether the composites are at least one standard 
deviation above or below the mean. We compare 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 web-interface or CMS-qualified registry, and (2) average beneficiary risk
  score is in the top 25 percent of all beneficiary risk scores.

    To ensure budget neutrality, we first aggregate 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 physicians subject to the VM that fall within 
Category 2. Using the aggregate downward payment adjustment amount, we 
then calculate the upward payment adjustment factor (x). These 
calculations will be done after the performance period has ended.
    In the proposed rule, we presented estimates on the number of 
eligible professionals and physician groups, by group size, based on CY 
2012 claims 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 QRURs are available on the CMS 
Web site at http://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/PhysicianFeedbackProgram/2012-QRUR.html in a document titled 
``Experience Report for the Performance Year 2012 Quality and Resource 
Use Reports''.
    On September 30, 2014, we made QRURs available 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 based 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 Sec.  414.1210(c), there are 
1,010 groups of 100 or more eligible professionals (as identified by 
their Taxpayer Identification 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 the 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; 
therefore, these groups will receive an upward, neutral, or downward 
adjustment in CY 2015 based 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 (77 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 groups 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 will 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 eligible 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 shows 
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 
Web site at http://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/PhysicianFeedbackProgram/ValueBasedPaymentModifier.html.

[[Page 67999]]



      Table 98--Distribution Using 2013 Data of Quality 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%              +1.0x              +2.0x
                                                                       (0)                (2)                (0)
Average Cost...........................................              -0.5%              +0.0%              +1.0x
                                                                       (5)               (87)               (14)
High Cost..............................................              -1.0%              -0.5%              +0.0%
                                                                       (2)                (2)                (0)
----------------------------------------------------------------------------------------------------------------

    Of the 706 groups in Category 1, 573 groups elected to not have 
their CY 2015 VM calculated using the quality-tiering methodology; 
therefore, their 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 the two subcategories 
(a) or (b) of Category 1. There were 289 groups that did not self-
nominate for the PQRS as a group, and 15 groups that self-nominated for 
the PQRS as a group, but did not report at least one measure. Groups in 
Category 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 physicians in groups with 100 
or more eligible professionals that are in Category 1 and elected 
quality-tiering will be subject to upward, downward, or no payment 
adjustment under the 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 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 eligible 
professionals subject to the VM in CY 2015, including findings based on 
the data contained in the 2013 QRURs for all groups of physicians and 
solo practitioners.
14. Interim Revisions to the Electronic Health Record (EHR) Incentive 
Program
    This interim final rule will allow us flexibility in setting the 
deadline for significant hardship exception applications. We refer 
readers 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 
Electronic Health Record (EHR) Incentive Programs for 2014 and Other 
Changes to the EHR Incentive Program; and Health Information 
Technology; Revisions to the Certified EHR Technology Definition and 
EHR Certification Changes Related to Standards; Final Rule (79 FR 
52911-52933).

G. Alternatives Considered

    This final rule with comment period contains a range of policies, 
including some provisions related to specific statutory provisions. The 
preceding preamble provides descriptions of the statutory provisions 
that are addressed, identifies those policies when discretion has been 
exercised, presents rationale for our final policies and, where 
relevant, alternatives 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 measuring, submitting, and analyzing quality data; 
establishing the basis for the value-based payment modifier to adjust 
physician payment beginning in CY 2015; improved accuracy in payment 
through revisions 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 coinsurance (which is 20 percent 
of the fee schedule amount if applicable for the particular provision 
after the beneficiary has met the deductible). To illustrate this 
point, as shown in Table 94, the CY 2014 national payment amount in the 
nonfacility setting for CPT code 99203 (Office/outpatient visit, new) 
is $108.18, which means that in CY 2014 a beneficiary would be 
responsible for 20 percent of this amount, or $21.64. Based on this 
final rule with comment period, using the January 1-March 31, 2015 CF 
of 35.8013, the CY 2015 national payment amount in the nonfacility 
setting for CPT code 99203, as shown in Table 94, is $109.19, which 
means that, in CY 2015, the beneficiary coinsurance for this service 
would be $21.84. In addition, we are finalizing a change in our 
definition of colorectal cancer screening test. As a result, 
beneficiary liability will not be applied to anesthesia billed in 
conjunction with a colorectal cancer screening test.

I. Accounting Statement

    As required by OMB Circular A-4 (available at http://www.whitehouse.gov/omb/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: Classification of Estimated Expenditures
------------------------------------------------------------------------
                Category                            Transfers
------------------------------------------------------------------------
CY 2015 Annualized Monetized Transfers.  Estimated decrease in
                                          expenditures of $14.7 billion
                                          for PFS conversion factor
                                          update.

[[Page 68000]]

 
From Whom to Whom?.....................  Federal Government to
                                          physicians, other
                                          practitioners and providers
                                          and suppliers who receive
                                          payment under Medicare.
CY 2015 Annualized Monetized Transfers.  Estimated 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: Classification of Estimated Costs,
                          Transfer, and Savings
------------------------------------------------------------------------
                Category                             Transfer
------------------------------------------------------------------------
CY 2015 Annualized Monetized Transfers   $9 million.
 of beneficiary cost coinsurance.
From Whom to Whom?.....................  Beneficiaries to Federal
                                          Government.
------------------------------------------------------------------------

J. Conclusion

    The analysis in the previous sections, together with the remainder 
of this preamble, provides an initial ``Regulatory Flexibility 
Analysis.'' The previous analysis, together with the preceding portion 
of this preamble, provides a Regulatory Impact Analysis.
    In accordance with the provisions of Executive Order 12866, this 
regulation was reviewed by the Office of Management and Budget.

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 procedure, Health facilities, Health 
professions, Kidney diseases, Medical devices, Medicare, Reporting and 
recordkeeping requirements, Rural areas, X-rays.

42 CFR Part 410

    Health facilities, Health professions, Kidney diseases, 
Laboratories, 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 facilities, Medicare, 
Puerto Rico, Reporting and recordkeeping requirements.

42 CFR Part 413

    Health facilities, Kidney diseases, Medicare, Reporting and 
recordkeeping requirements.

42 CFR Part 414

    Administrative practice and procedure, Health facilities, Health 
professions, Kidney diseases, Medicare, Reporting and recordkeeping 
requirements.

42 CFR Part 425

    Administrative practice and procedure, Health facilities, Health 
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 procedure, Electronic health records, 
Health facilities, Health professions, Health maintenance organizations 
(HMO), Medicaid, Medicare, Penalties, Privacy, Reporting and 
recordkeeping requirements.

42 CFR Part 498

    Administrative practice and procedure, Health facilities, Health 
professions, Medicare, Reporting and recordkeeping requirements.
    For the reasons set forth in the preamble, the Centers for Medicare 
& Medicaid Services amends 42 CFR chapter IV as set forth below:--

PART 403--SPECIAL PROGRAMS AND PROJECTS

0
1. The authority citation for part 403 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).


Sec.  403.902  [Amended]

0
2. In Sec.  403.902, remove the definition of ``Covered device''.
0
3. Section 403.904 is amended by--
0
A. Revising paragraphs (c)(8), (d)(3), and (d)(4).
0
B. Adding paragraphs (d)(5) and (d)(6).
0
C. Revising paragraph (f)(1)(iv).
0
D. Removing paragraph (g).
0
E. Redesignating paragraphs (h) and (i) as paragraphs (g) and (h), 
respectively.
0
F. Amending newly redesignated paragraph (h)(2)(ii) by removing 
``paragraph (i)(2)(i) of this section'' and adding in its place 
``paragraph (h)(2)(i) of this section''.
0
G. Amending newly redesignated paragraph (h)(2)(iii) by removing 
``paragraph (i)(2)(ii) of this section'' and adding in its place 
``paragraph (h)(2)(i) of this section''.
    The revisions and additions read as follows:


Sec.  403.904  Reports of payments or other transfers of value to 
covered recipients.

* * * * *
    (c) * * *
    (8) Related covered drug, device, biological or medical supply. 
Report the marketed name of the related covered drugs, devices, 
biologicals, or medical supplies, and therapeutic area or product 
category unless the payment or other transfer of value is not related 
to a particular covered drug, device, biological 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

[[Page 68001]]

of value is not related to any covered or non-covered drug, 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 specified in paragraph 
(c)(8) of this section), for drugs and biologicals, the relevant 
National Drug Code(s), if any, for devices and medical supplies and 
report a therapeutic area or product category if a marketed name is not 
available.
* * * * *


Sec.  403.906  [Amended]

0
4. In Sec.  403.906, amend paragraph (b)(6) by removing ``Sec.  
403.904(c) through (i)'' and by adding in its place ``Sec.  403.904(c) 
through (h).''
0
5. New subpart K is added to part 403 to read as follows:
Subpart K--Access to Identifiable Data for the 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


Sec.  403.1100  Purpose and scope.

    The regulations in this subpart implement section 1115A of the Act. 
The intent of that section is to enable CMS to test innovative payment 
and service delivery models to reduce program expenditures while 
preserving and/or enhancing the quality of care furnished to 
individuals under titles XVIII, XIX, and XXI of the Act. The Secretary 
is also required to conduct an evaluation of each model tested.


Sec.  403.1105  Definitions.

    For purposes of this subpart--
    Applicable titles means Titles XVIII, XIX, or XXI of the Act.


Sec.  403.1110  Evaluation of models.

    (a) Evaluation. The Secretary conducts an evaluation of each model 
tested under section 1115A of the Act. Such evaluation must include an 
analysis of the following:
    (1) The quality of care furnished under the model, including the 
measurement of patient-level outcomes and patient-centeredness criteria 
determined appropriate by the Secretary.
    (2) The changes in spending under the applicable titles by reason 
of the model.
    (b) Information. Any State or other entity participating in the 
testing of a model under section 1115A of the Act must collect and 
report such information, including ``protected health information'' as 
that term is defined at 45 CFR 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 INSURANCE FOR THE AGED AND DISABLED

0
6. The authority citation for part 405 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 Public Health Service Act (42 U.S.C. 
263a).


0
7. Section 405.400 is amended by revising the definition of ``Emergency 
care services'' to read as follows:


Sec.  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 hospital available and equipped to furnish those 
services.
* * * * *


Sec.  405.420  [Amended]

0
8. In Sec.  405.420, amend paragraph (e), by removing the phrase 
``Medicare+Choice'' and adding in its place the phrase ``Medicare 
Advantage''.


Sec.  405.425  [Amended]

0
9. In Sec.  405.425, amend paragraph (a) by removing the phrase 
``Medicare+Choice'' and adding in its place the phrase ``Medicare 
Advantage''.


Sec.  405.450  [Amended]

0
10. In Sec.  405.450, amend paragraph (a) by removing the reference 
``Sec.  405.803'' and adding in its place the reference ``Sec.  
498.3(b) of this chapter'' and amend paragraph (b) by removing the 
reference ``Sec.  405.803'' and adding in its place ``Sec.  405.924''.


Sec.  405.455  [Amended]

0
11. In Sec.  405.455, remove the phrase ``Medicare+Choice'' and add in 
its place the phrase ``Medicare Advantage'' wherever it appears.
0
12. Section 405.924 is amended by adding paragraph (b)(15) to read as 
follows:


Sec.  405.924  Actions that are initial determinations.

* * * * *
    (b) * * *
    (15) A claim not payable to a beneficiary for the services of a 
physician who has opted-out.
* * * * *

0
13. Section 405.2413 is amended by--
0
A. Amending paragraph (a)(4) by removing ``;'' and by adding in its 
place ``; and''.
0
B. Revising paragraph (a)(5).
0
C. Removing paragraph (a)(6).
    The revision reads as follow:


Sec.  405.2413  Services and supplies incident to a physician's 
services.

    (a) * * *
    (5) Furnished under the direct supervision of a physician.
* * * * *

0
14. Section 405.2415 is amended by--
0
A. Revising the section heading and paragraph (a)(5).
0
B. Removing paragraph (a)(6).
    The revision reads as follows:


Sec.  405.2415  Services and supplies incident to nurse 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.
* * * * *

0
15. Section 405.2452 is amended by--
0
A. Amending paragraph (a)(4) by removing ``;'' and by adding in its 
place ``; and''.
0
B. Revising paragraph (a)(5).
0
C. Removing paragraph (a)(6).
    The revision reads as follows:


Sec.  405.2452  Services and supplies incident to clinical psychologist 
and clinical social worker services.

    (a) * * *
    (5) Furnished under the direct supervision of a clinical 
psychologist or clinical social worker.
* * * * *

0
16. Section 405.2463 is revised to read as follows:


Sec.  405.2463  What constitutes a visit.

    (a) Visit--General. (1) For RHCs, a visit is either of the 
following:

[[Page 68002]]

    (i) Face-to-face encounter between a RHC patient and one of the 
following:
    (A) Physician.
    (B) Physician assistant.
    (C) Nurse practitioner.
    (D) Certified nurse midwife.
    (E) Visiting registered professional 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 medical nutrition therapy services as 
defined in part 410, subpart G, of this chapter.
    (B) A qualified provider of outpatient diabetes self-management 
training services as defined in part 410, subpart H, of this chapter.
    (b) Visit--Medical. (1) A medical 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.
    (v) Visiting registered professional 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 mental 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 paragraph 
(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 that 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 separate 
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 for more than 1 
visit per day when the conditions in paragraph (c)(1) of this section 
are met.
    (3) For FQHCs that are authorized to bill under 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 mental health visit on the same day.

PART 410--SUPPLEMENTARY MEDICAL INSURANCE (SMI) BENEFITS

0
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.


0
18. Section 410.26 is amended by revising paragraphs (b)(5) and (b)(6) 
to read as follows:


Sec.  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 supplies furnished incident to transitional care management and 
chronic care management services 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) supervising the auxiliary personnel need not be the 
same physician (or other practitioner) upon whose professional service 
the incident to service is based.
    (6) Services and supplies must be furnished by the physician, 
practitioner with an incident to benefit, or auxiliary personnel.
* * * * *

0
19. Section 410.37 is amended by revising paragraph (a)(1)(iii) to read 
as follows:


Sec.  410.37  Colorectal cancer screening tests: Conditions for and 
limitations on coverage.

    (a) * * *
    (1) * * *
    (iii) Screening colonoscopies, including anesthesia furnished in 
conjunction with the service.
* * * * *

0
20. Section 410.59 is amended by revising paragraph (c)(1)(ii) to read 
as follows:


Sec.  410.59  Outpatient occupational therapy services: Conditions.

* * * * *
    (c) * * *
    (1) * * *
    (ii) Engage in the private practice of occupational 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.
* * * * *
0
21. Section 410.60 is amended by revising paragraph (c)(1)(ii) to read 
as follows:


Sec.  410.60  Outpatient physical therapy services: Conditions.

* * * * *
    (c) * * *
    (1) * * *
    (ii) Engage in the private practice of physical 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.
* * * * *
0
22. Section 410.62 is amended by revising paragraph (c)(1)(ii) to read 
as follows:


Sec.  410.62  Outpatient speech-language pathology 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 following practice 
types: a solo practice, partnership, or group practice; or as an 
employee of one of these.
* * * * *
0
23. Section 410.78 is amended by revising paragraph (b) introductory 
text and paragraph (f) to read as follows:


Sec.  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:
* * * * *
    (f) Process for adding or deleting services. Changes to the list of 
Medicare

[[Page 68003]]

telehealth services are made through the annual physician fee schedule 
rulemaking process. A list of the services covered as telehealth 
services under this section is available on the CMS Web site.

PART 411--EXCLUSIONS FROM MEDICARE AND LIMITATIONS ON MEDICARE 
PAYMENT

0
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).

0
25. Section 411.15 is amended by adding paragraph (p)(2)(xvii) to read 
as follows:


Sec.  411.15  Particular services excluded from coverage.

* * * * *
    (p) * * *
    (2) * * *
    (xvii) Those RHC and FQHC services that are described in Sec.  
405.2411(b)(2) of this chapter.
* * * * *

PART 412--PROSPECTIVE PAYMENT SYSTEMS FOR INPATIENT HOSPITAL 
SERVICES

0
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.


Sec.  412.64  [Amended]

0
27. In 412.64--
0
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''.
0
B. Amend paragraph (d)(4)(ii)(A) by removing the phrase ``by April 1 of 
the year before the applicable payment adjustment year'' and adding in 
its place the phrase ``by April 1 of the year before the applicable 
payment adjustment year, or a later date specified by CMS''.
0
C. Amend paragraph (d)(4)(ii)(B)(1) by removing the phrase ``April 1 of 
the year before the applicable payment adjustment year'' and adding in 
its place the phrase ``April 1 of the year before the applicable 
payment adjustment year, or a later date specified by CMS''.
0
D. Amend paragraph (d)(4)(ii)(B)(2) by removing the phrase ``April 1 of 
the year before the applicable payment adjustment year'' and adding 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 REASONABLE COST REIMBURSEMENT; PAYMENT FOR 
END-STAGE RENAL DISEASE SERVICES; OPTIONAL PROSPECTIVELY DETERMINED 
PAYMENT RATES FOR SKILLED NURSING FACILITY SERVICES

0
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).


Sec.  413.70  [Amended]

0
29. Amend Sec.  413.70 by:
0
A. Amending paragraph (a)(6)(ii) introductory text by removing the 
phrase ``no later than November 30 after the close of the applicable 
EHR reporting period'' and adding in its place the phrase '' no later 
than November 30 after the close of the applicable EHR reporting 
period, or a later date specified by CMS''.
0
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 MEDICAL AND OTHER HEALTH SERVICES

0
30. The authority citation for part 414 continues to read as follows:

    Authority: Secs. 1102, 1871, and 1881(b)(l) of the Social 
Security Act (42 U.S.C. 1302, 1395hh, and 1395rr(b)(l)).

0
31. Section 414.24 is amended by--
0
A. Revising the section heading, and paragraphs (a) and (b).
0
B. Redesignating paragraph (c) as paragraph (d).
0
C. Adding new paragraph (c).
    The revisions and addition read as follows:


Sec.  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 new 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 service that was not 
previously described or valued under the PFS using any other code or 
combination of codes.
    (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 rule), 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 and direct PE inputs for new 
codes in the manner described in paragraph (b) of this section.
    (2) Exception for new codes for which CMS does 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 interest 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 information 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.
* * * * *
0
32. Section 414.90 is amended by--
0
A. In paragraph (b) by revising the definition of ``Measures group''.
0
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 the phrase ``CAHPS 
for PQRS''.
0
C. In paragraphs (h)(4)(v) and (j)(4)(vi) remove the phrase ``CAHPS'' 
and add in its place the phrase ``CAHPS for PQRS''.
0
D. Redesignate paragraphs (j)(4) and (j)(5) as (j)(5) and (j)(6), 
respectively.
0
E. Adding new paragraphs (j)(4), (j)(7), (k)(4) and (m)(3).
0
F. Revising paragraph (m)(1).
    The revisions read as follows:


Sec.  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 
denominator definition and coding of the measures group identifies the 
condition or focus that is

[[Page 68004]]

shared across the measures within a particular measures group.
* * * * *
    (j) * * *
    (4) Satisfactory Reporting Criteria for Individual Eligible 
Professionals for the 2017 PQRS Payment Adjustment. An individual 
eligible professional 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 applies. Of the 9 measures reported, if the 
eligible professional sees at least 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 apply to the eligible professional, 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]
    (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 applies. Of the 9 measures reported, if the 
eligible professional sees at least 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 apply to the eligible professional, 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.
    (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 performance rate will not be 
counted.
    (iii) Via EHR Direct Product. 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 direct EHR product does 
not contain patient data for at least 9 measures covering at least 3 
domains, then the eligible professional must report the measures for 
which there is Medicare patient data. An eligible 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 the 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 group practices for the 
2017 PQRS payment adjustment. A group practice 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 the GPRO web interface. For the 12-month 2017 PQRS payment 
adjustment reporting period, for a group practice of 25 to 99 eligible 
professionals, 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 report on 100 
percent of assigned beneficiaries. A group practice must report on at 
least 1 measure for which there is Medicare patient data.
    (ii) Via Qualified Registry. For a group practice of 2 to 99 
eligible professionals, for the 12-month 2017 PQRS payment adjustment 
reporting 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 patients seen during the reporting 
period to which the measure applies; or if less than 9 measures 
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 
reporting period to which the measure applies. Of the measures 
reported, 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 contained in the 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 practice of 2 to 99 
eligible professionals, for the 12-month 2017 PQRS payment adjustment 
reporting period, report 9 measures covering at least 3 of the NQS 
domains. If a group practice'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 payment 
adjustment reporting period, report 9 measures covering at least 3 of 
the NQS domains. 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 measure for which there is Medicare patient data.
    (v) Via a Certified Survey Vendor in addition 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 
CAHPS for PQRS survey measures via a CMS-certified survey vendor and 
report at least 6 additional measures covering at least 2 of the NQS 
domains using a 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 
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 by CMS.
    (vi) Via a Certified Survey Vendor in addition a Direct EHR Product 
or EHR Data Submission Vendor. For a group practice of 2 or more 
eligible

[[Page 68005]]

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 domains 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 addition to the GPRO Web 
interface. (A) For a group practice of 25 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 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 would report on 100 percent of assigned beneficiaries. A 
group practice must report on at least 1 measure for which there is 
Medicare patient data.
    (B) [Reserved]
    (k) * * *
    (4) Satisfactory participation criteria for individual eligible 
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:
    (i) For the 12-month 2017 PQRS payment adjustment 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 the 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 outcome measures and 
at least 1 of the following types of measures--resource use, patient 
experience of care, efficiency/appropriate use or patient safety.
    (ii) [Reserved]
* * * * *
    (m) * * *
    (1) To request an informal review for reporting periods that occur 
prior to 2014, an eligible professional or group practice must submit a 
request to CMS within 90 days of the release of the feedback reports. 
To request an informal review for reporting periods that occur in 2014 
and subsequent years, an eligible professional 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.
    (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 reporting periods for which the corresponding informal review 
period applies.
* * * * *


Sec.  414.511  [Removed]

0
33. Section Sec.  414.511 is removed.
0
34. Section 414.610 is amended by revising paragraphs (c)(1)(ii) 
introductory text and (c)(5)(ii) to read as follows:


Sec.  414.610  Basis of payment.

* * * * *
    (c) * * *
    (1) * * *
    (ii) For services furnished during the 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 percent 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 the rural 
areas in the lowest quartile of population compared to the average cost 
per trip for the rural areas in the highest quartile of population. In 
making this estimate, CMS may use data provided by the GAO.
* * * * *

0
35. Section 414.1200 is amended by revising paragraphs (a) and (b)(5) 
to read as follows:


Sec.  414.1200  Basis and scope.

    (a) Basis. This subpart implements section 1848(p) of the Act by 
establishing a payment modifier that provides for differential payment 
starting in 2015 to a group of physicians and starting in 2017 to a 
group and a solo practitioner under the Medicare Physician Fee Schedule 
based on the quality of care furnished compared to cost during a 
performance period.
    (b) * * *
    (5) Additional measures for groups and solo practitioners.
* * * * *

0
36. Section 414.1205 is amended by--
0
A. Revising the definitions of ``Group of physicians'' and ``Value-
based payment modifier.''
0
B. Adding the definition of ``Solo practitioner'' in alphabetical 
order.
    The addition and revisions read as follows:


Sec.  414.1205  Definitions.

* * * * *
    Group of physicians (Group) means a single Taxpayer Identification 
Number (TIN) with 2 or more eligible professionals, as identified by 
their individual National Provider Identifier (NPI), who have 
reassigned their Medicare billing rights to the TIN.
* * * * *
    Solo practitioner means a single Taxpayer Identification 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 the percentage as determined 
under Sec.  414.1270 by which amounts paid to a group or solo 
practitioner 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.


0
37. Section 414.1210 is amended by--
0
A. Adding paragraphs (a)(3), (a)(4), (b)(2), (b)(3), and (b)(4).
0
B. Revising paragraph (c).
    The additions and revision reads as follows:

[[Page 68006]]

Sec.  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 based on the performance period for the payment 
adjustment period as described at Sec.  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 
nonphysician eligible professionals who are solo practitioners based on 
the performance period for the payment adjustment period as described 
at Sec.  414.1215.
    (b) * * *
    (2) Application of the value-based 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 payment 
modifier is applicable to physicians in groups with 2 or more eligible 
professionals and 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 
Sec.  414.1215. The value-based payment modifier for a group or solo 
practitioner that participates in an ACO under the 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 classified as ``average'' under Sec.  
414.1275(b).
    (B) The quality composite score is calculated under Sec.  
414.1260(a) using quality data reported by the ACO for the performance 
period through the ACO GPRO Web interface as required under Sec.  
425.504(a)(1) or another mechanism specified by CMS and the ACO all-
cause readmission measure.
    (C) For the CY 2017 payment adjustment period, the value-based 
payment modifier adjustment will be equal to the amount determined 
under Sec.  414.1275 for the payment adjustment period, except that if 
the ACO does not successfully report quality data as described in 
paragraph (b)(2)(i)(B) of this section for the performance period, such 
adjustment will be equal to -4% for groups with 10 or more eligible 
professionals and equal to -2% for groups with two to nine eligible 
professionals and for solo practitioners.
    (D) The same value-based payment modifier adjustment will be 
applied in the payment adjustment period to all groups based on size as 
specified under Sec.  414.1275 and solo practitioners that participated 
in the ACO during the performance period.
    (ii) For the CY 2018 payment adjustment period and each subsequent 
calendar year payment adjustment period, the value-based payment 
modifier is applicable to nonphysician eligible professionals in groups 
with 2 or more eligible professionals and to nonphysician eligible 
professionals 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 Sec.  414.1215. The value-
based payment modifier for nonphysician eligible professionals is 
determined in the same manner as for physicians 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 Primary Care Initiative.
    (i) For the CY 2017 payment adjustment period, the value-based 
payment modifier is applicable to physicians in groups with 2 or more 
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 Sec.  414.1215. For purposes of the 
value-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 billing under the TIN 
in the performance period is participating in the Pioneer ACO Model or 
CPC Initiative in the performance period. The value-based payment 
modifier for groups and solo practitioners that participate in the 
Pioneer ACO Model or the CPC Initiative during the performance period 
is determined based on paragraphs (b)(3)(i)(A) through (C) of this 
section.
    (A) The cost composite is classified as ``average'' under Sec.  
414.1275(b).
    (B) The quality composite is classified as ``average'' under Sec.  
414.1275(b).
    (C) The same value-based payment modifier adjustment will be 
applied in the payment adjustment period to all groups based on size as 
specified under Sec.  414.1275 and solo practitioners that participated 
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 payment 
modifier is applicable to physicians in groups with 2 or more eligible 
professionals and to physicians who are solo practitioners that 
participate in other similar Innovation Center models or CMS 
initiatives during the performance period for the payment adjustment 
period as described at Sec.  414.1215. For purposes of the value-based 
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 modifier for groups and 
solo practitioners that participate in a similar Innovation Center 
model or CMS initiative 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 physicians 
subject to the value-based payment modifier for the CY 2015 payment 
adjustment period is based on a query of PECOS on October 15, 2013. For 
each subsequent calendar year payment adjustment period, the list of 
groups and solo practitioners 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 
process during the applicable performance period described at Sec.  
414.1215. Groups are removed from the PECOS-generated list if, based on 
a claims analysis, the group did not have the required number of 
eligible professionals, as defined in Sec.  414.1210(a), that submitted 
claims during the performance period for the applicable calendar year 
payment adjustment period. Solo practitioners are removed 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.


Sec.  414.1220  [Amended]

0
38. In Sec.  414.1220, remove the phrase ``Groups of physicians'' and 
add in its place the phrase ``Solo practitioners and groups''.
0
39. Section 414.1225 is revised to read as follows:

[[Page 68007]]

Sec.  414.1225  Alignment of Physician Quality Reporting System quality 
measures and quality measures for the value-based payment modifier.

    All of the quality measures for which solo practitioners and groups 
(or individual eligible professionals within such groups) are eligible 
to report under the Physician Quality Reporting System in a given 
calendar year are used to calculate the value-based payment modifier 
for the applicable payment adjustment period, as defined in Sec.  
414.1215, to the extent a solo practitioner or a group (or individual 
eligible professionals within such group) submit data on such measures.

0
40. Section 414.1230 is amended by revising the section heading and the 
introductory text to read as follows:


Sec.  414.1230  Additional measures for groups and solo practitioners.

    The value-based payment modifier includes the following additional 
quality measures (outcome measures) as applicable for all groups and 
solo practitioners subject to the value-based payment modifier:
* * * * *


Sec.  414.1235  [Amended]

0
41. In Sec.  414.1235, amend paragraph (a) introductory text, by 
removing the phrase ``of physicians subject'' and add in its place the 
phrase ``and solo practitioners subject''.
0
42. Section 414.1240 is revised to read as follows:


Sec.  414.1240  Attribution for quality of care and cost measures.

    (a) Beneficiaries are attributed to groups and solo practitioners 
subject to the value-based payment modifier using a method generally 
consistent with the method of assignment of beneficiaries under Sec.  
425.402 of this chapter, for measures other than the Medicare Spending 
per Beneficiary measure.
    (b) For the Medicare Spending per Beneficiary (MSPB) measure, an 
MSPB episode is attributed to the group or the solo practitioner 
subject to the value-based payment modifier whose eligible 
professionals submitted the plurality of claims (as measured by 
allowable charges) under the group's or solo practitioner'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 Sec.  414.1215.


Sec.  414.1245  [Amended]

0
43. In Sec.  414.1245, amend the introductory text, by removing the 
phrase ``of physicians subject'' and add in its place the phrase ``and 
solo practitioner subject''.
0
44. Section 414.1250 is revised to read as follows:


Sec.  414.1250  Benchmarks for quality of care measures.

    (a) The benchmark for quality of care measures reported through the 
PQRS using the claims, registries, EHR, or web interface is the 
national mean for that measure's performance rate (regardless of the 
reporting mechanism) during the year prior to the performance period. 
In calculating the national benchmark, solo practitioners' and groups' 
(or individual eligible professionals' within such groups) performance 
rates are weighted by the number of beneficiaries used to calculate the 
solo practitioners' or groups' (or individual eligible professionals' 
within such groups) performance rate.
    (b) The benchmark for each outcome measure under Sec.  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 eligible professionals' 
within such groups) performance rates are weighted by the number of 
beneficiaries used to calculate the solo practitioners' or groups' (or 
individual eligible professionals' within such groups) performance 
rate.

0
45. Section 414.1255 is amended by revising paragraphs (b) and (c) to 
read as follows:


Sec.  414.1255  Benchmarks for cost measures.

* * * * *
    (b) Beginning with the CY 2016 payment adjustment period, the cost 
measures of a group and solo practitioner subject to the value-based 
payment modifier are adjusted to account for the group's and solo 
practitioner's specialty mix, by computing the weighted average of the 
national specialty-specific expected costs. Each national specialty-
specific expected cost is weighted by the proportion of each specialty 
in the group, the number of eligible professionals of each specialty in 
the group, and the number of beneficiaries attributed to the group.
    (c) The national specialty-specific expected costs referenced in 
paragraph (b) of this section are derived by calculating, for each 
specialty, the average cost of beneficiaries attributed to groups and 
solo practitioners that include that specialty.

0
46. Section 414.1265 is amended by revising the introductory text and 
paragraph (a) to read as follows:


Sec.  414.1265  Reliability of measures.

    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 have 20 or more cases for that measure.
    (a) In a performance period, if a group or solo practitioner has 
fewer than 20 cases for a measure, that measure is excluded from its 
domain and the remaining measures in the domain are given equal weight.
    (1) Starting with the CY 2017 payment adjustment period, the 
exception to this paragraph (a) is the all-cause hospital readmissions 
measure described at Sec.  414.1230(c). In a performance period, if a 
group or a solo practitioner has fewer than 200 cases for this all-
cause hospital readmissions measure, that measure is excluded from its 
domain and the remaining measures in the domain are given equal weight.
    (2) [Reserved]
* * * * *

0
47. Section 414.1270 is amended by revising paragraph (b)(4) and adding 
paragraph (c) to read as follows:


Sec.  414.1270  Determination and calculation of Value-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 payment 
adjustment for CY 2016 as specified by CMS, and all of those eligible 
professionals use a qualified clinical data registry and CMS is unable 
to receive quality performance data for them, the quality composite 
score for such group will be classified as ``average'' under Sec.  
414.1275(b)(1).
* * * * *
    (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 and a solo 
practitioner and a downward payment adjustment of -4.0 percent will be 
applied to a group with 10 or more eligible professionals subject to 
the value-based payment modifier if, during the applicable performance 
period as defined in Sec.  414.1215, the following apply:
    (i) Such group does not self-nominate for the PQRS GPRO and meet 
the criteria as a group to avoid the PQRS payment adjustment for CY 
2017 as specified by CMS; and

[[Page 68008]]

    (ii) Fifty percent of the eligible 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 
individual to avoid the PQRS payment adjustment for CY 2017 as 
specified by CMS.
    (2) For a group comprised of 10 or more eligible 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 Sec.  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 Sec.  
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 payment 
adjustment for CY 2017 as specified by CMS, and all of those eligible 
professionals use a qualified clinical data registry and CMS is unable 
to receive quality performance data for them, the quality composite 
score for such group will be classified as ``average'' under Sec.  
414.1275(b)(1).
    (5) A group and a solo practitioner subject to the value-based 
payment modifier will receive a cost composite score that is classified 
as ``average'' under Sec.  414.1275(b)(2) if such group and solo 
practitioner do not have at least one cost measure with at least 20 
cases.

0
48. Section 414.1275 is amended by--
0
A. Revising paragraph (a).
0
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.
0
C. Adding paragraphs (c)(3) and (d)(2).
    The revision and additions read as follows:


Sec.  414.1275  Value-based payment modifier quality-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 upon 
a comparison of the composite of quality of care measures and a 
composite of cost measures.
* * * * *
    (c) * * *
    (3) The following value-based payment modifier percentages apply to 
the CY 2017 payment adjustment period:
    (i) For groups with 10 or more eligible professionals:

    CY 2017 Value-Based Payment Modifier Amounts for the Quality-Tiering Approach for Groups 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, where `x' represents
  the upward payment adjustment factor.

    (ii) For groups with two to nine eligible professionals and solo 
practitioners:

    CY 2017 Value-Based Payment Modifier Amounts for the Quality-Tiering Approach for Groups With Two to Nine
                                  Eligible 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 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,
  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 population with an 
average risk score in the top 25 percent of the risk scores of 
beneficiaries nationwide and for the CY 2017 payment adjustment period 
are subject to the quality-tiering approach, receive a greater upward 
payment adjustment as follows:
    (i) Classified as high quality/low cost receive an upward 
adjustment of +5x (rather than +4x) if the group has 10 or more 
eligible professionals 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 average 
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.


Sec.  414.1285  [Amended]

0
49. In Sec.  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

0
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).


0
51. Section 425.308 is amended by revising paragraph (e) to read as 
follows:


Sec.  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

[[Page 68009]]

for the group practices that report under the Physician Quality 
Reporting System.

0
52. Section 425.502 is amended by--
0
A. In paragraph (a)(1), removing the phrase ``of an ACO's agreement, 
CMS'' and adding in its place the phrase ``of an ACO's first agreement 
period, CMS''
0
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 90th 
percentile is equal to or greater than 95 percent.''
0
C. Revising paragraph (a)(2).
0
D. Adding paragraphs (a)(3), (a)(4), (b)(4), and (e)(4).
    The revision and additions read as follows:


Sec.  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 continue 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.
    (4) The quality performance standard for a newly introduced measure 
is set at the level of complete and accurate reporting for the first 
two reporting periods for which reporting of the measure is required. 
For subsequent reporting periods, 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 measures that transition to pay for 
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 start 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 improvement 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 ACO'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 received for the domain may 
not exceed the maximum total points for the domain in the absence of 
the quality improvement measure.
    (v) If an ACO renews its participation 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.


0
53. Section 425.506 is amended by revising the section heading and 
adding paragraph (d) to read as follows:


Sec.  425.506  Incorporating reporting requirements related to adoption 
of Electronic health records technology.

* * * * *
    (d) Eligible professionals participating in an ACO under the Shared 
Savings Program satisfy the CQM reporting component of meaningful use 
for the Medicare EHR Incentive Program when the following occurs:
    (1) The eligible professional extracts data necessary for the ACO 
to satisfy the quality reporting requirements under this subpart from 
certified EHR technology.
    (2) The ACO reports the ACO GPRO measures through a CMS web 
interface.

PART 489--PROVIDER AGREEMENTS AND SUPPLIER APPROVAL

0
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).


0
55. Section 489.20 is amended by adding paragraph (s)(17) to read as 
follows:


Sec.  489.20  Basic commitments.

* * * * *
    (s) * * *
    (17) Those RHC and FQHC services that are described in Sec.  
405.2411(b)(2) of this chapter.
* * * * *

PART 495--STANDARDS FOR THE ELECTRONIC HEALTH RECORD TECHNOLOGY 
INCENTIVE PROGRAM

0
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).


Sec.  495.102  [Amended]

0
57. In 495.102--
0
A. Amend paragraph (d)(4)(i) by removing the phrase in the first 
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''.
0
B. Amend paragraph (d)(4)(i) by removing the 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''.
0
C. Amend paragraph (d)(4)(iii)(A) by removing the 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''.
0
D. Amend paragraph (d)(4)(iii)(B) by removing the phrase in the second 
sentence ``by July 1 of the year before the applicable payment 
adjustment year'' and adding in its place the phrase ``by July 1 of the 
year before the applicable payment adjustment year, or a later date 
specified by CMS''.
0
E. Amend the introductory text of paragraph (d)(4)(iv) introductory 
text by removing the phrase ``by July 1 of the year before the 
applicable payment adjustment year'' and adding in its place the phrase 
``by July 1 of the year before the applicable payment adjustment year, 
or a later date specified by CMS''.

[[Page 68010]]

PART 498--APPEALS PROCEDURES FOR DETERMINATIONS THAT AFFECT 
PARTICIPATION IN THE MEDICARE PROGRAM AND FOR DETERMINATIONS THAT 
AFFECT THE PARTICIPATION OF ICFs/IID AND CERTAIN NFs IN THE 
MEDICAID PROGRAM

0
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).


0
59. Section 498.3 is amended by adding paragraph (b)(19) to read as 
follow:


Sec.  498.3  Scope and applicability.

* * * * *
    (b) * * *
    (19) Whether a physician or practitioner has failed to properly 
opt-out, failed to maintain opt-out, failed to timely renew opt-out, 
failed to privately contract, or failed to properly terminate opt-out.
* * * * *

    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.
[FR Doc. 2014-26183 Filed 10-31-14; 4:15 pm]
BILLING CODE 4120-01-P


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