[Federal Register Volume 79, Number 219 (Thursday, November 13, 2014)]
[Rules and Regulations]
[Pages 67547-68010]
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 [email protected].

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:
     Misvalued PFS Codes.
     Telehealth Services.
     Chronic Care Management Services.
     Establishing Values for New, Revised, and Misvalued Codes.
     Updating the Ambulance Fee Schedule regulations.
     Changes in Geographic Area Delineations for Ambulance 
Payment.
     Updating the--
    ++ Physician Compare Web site.
    ++ Physician Quality Reporting System.
    ++ Medicare Shared Savings Program.
    ++ Electronic Health Record (EHR) Incentive Program.
     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.

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    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.

 The 1.0 floor on the work geographic practice cost index
 The exceptions process for outpatient therapy caps
 The manual medical review process for therapy services
 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:
     Codes that account for the majority of spending under the 
PFS.
     Codes for services that have experienced a substantial 
change in the hospital length of stay or procedure time.
     Codes for which there may be a change in the typical site 
of service since the code was last valued.
     Codes for which there is a significant difference in 
payment for the same service between different sites of service.
     Codes for which there may be anomalies in relative values 
within a family of codes.
     Codes for services where there may be efficiencies when a 
service is furnished at the same time as other services.
     Codes with high intra-service work per unit of time.
     Codes with high PE RVUs.
     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:
     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).
     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.
     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:
     If the service is a global service (that is, a service 
with global, professional, and technical components), then the indirect 
PE allocator is: Indirect percentage (direct PE RVUs/direct percentage) 
+ clinical labor PE RVUs + work RVUs.
     If the clinical labor PE RVUs exceed the work RVUs (and 
the service is not a global service), then the 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.
     The first part does not vary by service and is the 
indirect percentage (direct PE RVUs/direct percentage).
     The second part is either the work 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
     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.
------------------------------------------------------------------------

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

[[Page 67557]]

with all physical therapy services to the specialty of physical 
therapy.
     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).
     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.
     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:
     Codes and families of codes for which there has been the 
fastest growth;
     Codes and families of codes that have experienced 
substantial changes in PEs;
     Codes that are recently established for new technologies 
or services;
     Multiple codes that are frequently billed in conjunction 
with furnishing a single service;
     Codes with low relative values, particularly those that 
are often billed multiple times for a single treatment;
     Codes which have not been subject to review since the 
implementation of the RBRVS (the so-called `Harvard-valued codes'); and
     Other codes determined to be appropriate by the Secretary.
    Section 220(c) of the Protecting Access to Medicare Act of 2014 
(PAMA) further expanded the categories of codes that the Secretary is 
directed to examine by adding nine additional categories. These are:
     Codes that account for the majority of spending under the 
PFS;
     Codes for services that have experienced a substantial 
change in the hospital length of stay or procedure time;
     Codes for which there may be a change in the typical site 
of service since the code was last valued;
     Codes for which there is a significant difference in 
payment for the same service between different sites of service;
     Codes for which there may be anomalies in relative values 
within a family of codes;

[[Page 67574]]

     Codes for services where there may be efficiencies when a 
service is furnished at the same time as other services;
     Codes with high intra-service work per unit of time;
     Codes with high PE RVUs; and
     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:
     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.
     An anomalous relationship between the code being proposed 
for review and other codes.
     Evidence that technology has changed physician work, that 
is, diffusion of technology.
     Analysis of other data on time and effort measures, such 
as operating room logs or national and other representative databases.
     Evidence that incorrect assumptions were made in the 
previous valuation of the service, such as a misleading vignette, 
survey, or flawed crosswalk assumptions in a previous evaluation.
     Prices for certain high cost supplies or other direct PE 
inputs that are used to determine PE RVUs are inaccurate and do not 
reflect current information.
     Analyses of work time, work RVU, or direct PE inputs using 
other data sources (for example, VA NSQIP, STS National Database, and 
the PQRS databases).
     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]]

     G0416 (Surgical pathology, gross and microscopic 
examination for prostate needle biopsies, any method; 10-20 specimens).
     G0417 (Surgical pathology, gross and microscopic 
examination for prostate needle biopsies, any method; 21-40 specimens).
     G0418 (Surgical pathology, gross and microscopic 
examination for prostate needle biopsies, any method; 41-60 specimens).
     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:
     Preoperative Visits--Preoperative visits after the 
decision is made to operate beginning with the day before the day of 
surgery for major procedures and the day of surgery for minor 
procedures;
     Intra-operative Services--Intra-operative services that 
are normally a usual and necessary part of a surgical procedure;
     Complications Following Surgery--All additional medical or 
surgical services required of the surgeon during the postoperative 
period of the surgery because of complications that do not require 
additional trips to the operating room;
     Postoperative Visits--Follow-up visits during the 
postoperative period of the surgery that are related to recovery from 
the surgery;
     Postsurgical Pain Management--By the surgeon;
     Supplies--Except for those identified as exclusions; and
     Miscellaneous Services--Items such as dressing changes; 
local incisional care; removal of operative pack; removal of cutaneous 
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

[[Page 67583]]

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:
     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;
     Avoid potentially duplicative or unwarranted payments when 
a beneficiary receives post-operative care

[[Page 67586]]

from a different practitioner during the global period;
     Eliminate disparities between the payment for E/M services 
in global periods and those furnished individually;
     Maintain the same-day packaging of pre- and post-operative 
physicians' services in the 0-day global; and
     Facilitate availability of more accurate data for new 
payment models and quality research.
    As we transition these codes, we would need to establish RVUs that 
reflect the change in the global period for all the codes currently 
valued as 10- and 90-day global surgery services. We sought assistance 
from stakeholders on various aspects of this task. Prior to 
implementing these changes, we intend to gather 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:
     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.
     Valuing one code within a family through the current 
valuation process and then using magnitude estimation to value the 
remaining services in the family.
     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:
     The service must be furnished via an interactive 
telecommunications system.
     The practitioner furnishing the service must meet the 
telehealth requirements, as well as the usual Medicare requirements.
     The service must be furnished to an eligible telehealth 
individual.
     The individual receiving the services must be in an 
eligible originating site.
    When all of these conditions are met, 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:
     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.
     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:
     Ability to diagnose a medical condition in a patient 
population without access to clinically appropriate in-person 
diagnostic services.
     Treatment option for a patient population without access 
to clinically appropriate in-person treatment options.
     Reduced rate of complications.
     Decreased rate of subsequent diagnostic or therapeutic 
interventions (for example, due to reduced rate of recurrence of the 
disease process).
     Decreased number of future hospitalizations or physician 
visits.
     More rapid beneficial resolution of the disease process 
treatment.
     Decreased pain, bleeding, or other quantifiable symptom.
     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:
     CPT codes 90845 (Psychoanalysis); 90846 (family 
psychotherapy (without the patient present); and 90847 (family 
psychotherapy (conjoint psychotherapy) (with patient present);
     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,
     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:
     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).
     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.
     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.
     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.
     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.
     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.
     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:
     Psychotherapy services CPT codes 90845, 90846 and 90847.
     Prolonged service office CPT codes 99354 and 99355.
     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:
     Removing geographic restrictions to include both rural and 
urban areas.
     Revising permissible originating sites to include a 
patient's home, domiciliary care and first responder vehicles.

[[Page 67602]]

     Adopting a broader definition of telehealth technologies 
to include services provide via mobile technology, including emails, 
phone calls, and store-and-forward technologies.
     Adding physical and occupational therapists as 
practitioners who can remotely furnish telehealth services.
     Adding more services to the telehealth list, including 
services under category 2.
     Prioritizing coverage of services that include care 
coordination with the patient's medical home and/or existing treating 
physicians.
     Considering the use of telehealth technology for the 
purpose of furnishing direct supervision of services furnished by on-
site practitioners.
     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:
     Propose work and MP RVUs and direct PE inputs for all new, 
revised and potentially misvalued codes in a proposed rule.
     Propose changes in work and MP RVUs and direct PE inputs 
in the proposed rule for new, revised, and potentially misvalued codes 
for which we receive RUC recommendations in time; continue to establish 
interim final values in the final rule for other new, revised, and 
potentially misvalued codes.
     Increase our efforts to make available more information 
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:
     Is this proposal preferable to the present process? Is 
another one of the alternatives better?
     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?
     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

[[Page 67611]]

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:
     One to two clinicians representing the commenting 
organization.
     One to two primary care clinicians nominated by the 
American Academy of Family Physicians and the American College of 
Physicians.
     Four Contractor Medical Directors (CMDs).
     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:
     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)).
     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).
     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/).
     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).
     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).
     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).
     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):
     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:
     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).
    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:
     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).
    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.
     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.
     Continuity of care with a designated practitioner or 
member of the care team with whom the patient is able to get successive 
routine appointments.
     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.
     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.
     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.
     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.
     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):
     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.
     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.
     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.
     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.
     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:
     A full list of problems, medications and medication 
allergies in the EHR must inform the care plan, care coordination and 
ongoing clinical care.
     Communication to and from home and community based 
providers regarding the patient's psychosocial needs and functional 
deficits must be documented in the patient's medical record.
     Inform the beneficiary of the availability of CCM services 
and obtain his or her written agreement to have the services 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.
     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:
     Patient List Creation (45 CFR 170.314(a)(14)), which would 
support the required element of service for preventive services and 
routine appointments, and could help provide registry types of 
functions for the practice to use in managing patients who have agreed 
to participate in the chronic care management service.
     Patient-Specific Education Resources (Sec.  
170.314(a)(15)), which would help assure the ability to provide the 
patient with relevant educational materials about their chronic disease 
conditions.
     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.
     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.
     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:
     A full list of problems, medications and medication 
allergies in the EHR must inform the care plan, care coordination and 
ongoing clinical care.
     Communication to and from home and community based 
providers regarding the patient's psychosocial needs and functional 
deficits must be documented in the patient's medical record.
     Inform the beneficiary of the availability of CCM services 
and obtain his or her written agreement to have the services 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.
     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    Format clinical
 and among health care providers and      summaries according to CCM
 settings, including referrals to other   certified technology.
 clinicians; follow-up after an           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.
     Transient patients--Patients traveling away from home 
(less than full month);
     Home dialysis patients (less than full month);
     Partial month where there were one or more face-to-face 
visits without the comprehensive visit and either the patient was 
hospitalized before a complete assessment was furnished, dialysis 
stopped due to death, or the patient received a kidney transplant.
     Patients who have a permanent change in their MCP 
physician during the month.
    Additionally, we provided billing guidelines 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:
     Physicians' services.
     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.''
     Outpatient physical therapy services and outpatient 
occupational therapy services,

[[Page 67735]]

     Services of PAs, certified registered nurse anesthetists, 
certified nurse midwives, clinical psychologists, clinical social 
workers, nurse practitioners, and certified nurse specialists.
     Screening tests for prostate cancer, colorectal cancer, 
and glaucoma.
     Screening mammography, screening pap smears, and screening 
pelvic exams.
     Diabetes outpatient self-management training (DSMT) 
services.
     Medical Nutrition Therapy (MNT) services.
     Diagnostic x-ray tests, diagnostic laboratory tests, and 
other diagnostic tests (including outpatient diagnostic laboratory 
tests paid through intermediaries).
     X-ray, radium, and radioactive isotope therapy.
     Surgical dressings, splints, casts, and other devices used 
for the reduction of fractures and dislocations.
     Bone mass measurements.
     An initial preventive physical exam.
     Cardiovascular screening blood tests.
     Diabetes screening tests.
     Telehealth services.
     Physician work and resources to establish and document the 
need for a power mobility device.
     Additional preventive services.
     Pulmonary rehabilitation.
     Cardiac rehabilitation.
     Intensive cardiac rehabilitation.
     Kidney disease education (KDE) services.
     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--
     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.
     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:
     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.
     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:
     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)
     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--
     The ambulance benefit cover transportation services only 
if other means of transportation are contraindicated by the 
beneficiary's medical condition; and
     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

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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

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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 
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