[Federal Register Volume 79, Number 219 (Thursday, November 13, 2014)]
[Rules and Regulations]
[Pages 67548-68010]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2014-26183]
[[Page 67547]]
Vol. 79
Thursday,
No. 219
November 13, 2014
Part II
Department of Health and Human Services
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Centers for Medicare and Medicaid Services
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42 CFR Parts 403, 405, 410, et al.
Medicare Program; Revisions to Payment Policies Under the Physician
Fee Schedule, Clinical Laboratory Fee Schedule, Access to Identifiable
Data for the Center for Medicare and Medicaid Innovation Models & Other
Revisions to Part B for CY 2015; Final Rule
Federal Register / Vol. 79 , No. 219 / Thursday, November 13, 2014 /
Rules and Regulations
[[Page 67548]]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Medicare & Medicaid Services
42 CFR Parts 403, 405, 410, 411, 412, 413, 414, 425, 489, 495, and
498
[CMS-1612-FC]
RIN 0938-AS12
Medicare Program; Revisions to Payment Policies Under the
Physician Fee Schedule, Clinical Laboratory Fee Schedule, Access to
Identifiable Data for the Center for Medicare and Medicaid Innovation
Models & Other Revisions to Part B for CY 2015
AGENCY: Centers for Medicare & Medicaid Services (CMS), HHS.
ACTION: Final rule with comment period.
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SUMMARY: This major final rule with comment period addresses changes to
the physician fee schedule, and other Medicare Part B payment policies
to ensure that our payment systems are updated to reflect changes in
medical practice and the relative value of services, as well as changes
in the statute. See the Table of Contents for a listing of the specific
issues addressed in this rule.
DATES: Effective date: The provisions of this final rule are effective
on January 1, 2015, with the exception of amendments to parts 412, 413,
and 495 which are effective October 31, 2014.
Comment date: To be assured consideration, comments must be
received at one of the addresses provided below, no later than 5 p.m.
on December 30, 2014.
Compliance date: The compliance date for new data collection
requirements in Sec. 403.904(c)(8) is January 1, 2016.
ADDRESSES: In commenting, please refer to file code CMS-1612-FC.
Because of staff and resource limitations, we cannot accept comments by
facsimile (FAX) transmission.
You may submit comments in one of four ways (please choose only one
of the ways listed):
1. Electronically. You may submit electronic comments on this
regulation to www.regulations.gov. Follow the instructions for
``submitting a comment.''
2. By regular mail. You may mail written comments to the following
address ONLY: Centers for Medicare & Medicaid Services, Department of
Health and Human Services, Attention: CMS-1612-FC, P.O. Box 8013,
Baltimore, MD 21244-8013.
Please allow sufficient time for mailed comments to be received
before the close of the comment period.
3. By express or overnight mail. You may send written comments to
the following address ONLY: Centers for Medicare & Medicaid Services,
Department of Health and Human Services, Attention: CMS-1612-FC, Mail
Stop C4-26-05, 7500 Security Boulevard, Baltimore, MD 21244-1850.
4. By hand or courier. If you prefer, you may deliver (by hand or
courier) your written comments before the close of the comment period
to either of the following addresses:
a. For delivery in Washington, DC--Centers for Medicare & Medicaid
Services, Department of Health and Human Services, Room 445-G, Hubert
H. Humphrey Building, 200 Independence Avenue SW., Washington, DC
20201.
(Because access to the interior of the Hubert H. Humphrey Building
is not readily available to persons without federal government
identification, commenters are encouraged to leave their comments in
the CMS drop slots located in the main lobby of the building. A stamp-
in clock is available for persons wishing to retain a proof of filing
by stamping in and retaining an extra copy of the comments being
filed.)
b. For delivery in Baltimore, MD--Centers for Medicare & Medicaid
Services, Department of Health and Human Services, 7500 Security
Boulevard, Baltimore, MD 21244-1850.
If you intend to deliver your comments to the Baltimore address,
please call telephone number (410) 786-7195 in advance to schedule your
arrival with one of our staff members.
Comments mailed to the addresses indicated as appropriate for hand
or courier delivery may be delayed and received after the comment
period.
FOR FURTHER INFORMATION CONTACT: Donta Henson, (410) 786-1947 for any
physician payment issues not identified below.
Gail Addis, (410) 786-4522, for issues related to the refinement
panel.
Chava Sheffield, (410) 786-2298, for issues related to practice
expense methodology, impacts, the sustainable growth rate, conscious
sedation, or conversion factors.
Kathy Kersell, (410) 786-2033, for issues related to direct
practice expense inputs.
Jessica Bruton, (410) 786-5991, for issues related to potentially
misvalued services or work RVUs.
Craig Dobyski, (410) 786-4584, for issues related to geographic
practice cost indices or malpractice RVUs.
Ken Marsalek, (410) 786-4502, for issues related to telehealth
services.
Pam West, (410) 786-2302, for issues related to conditions for
therapists in private practice or therapy caps.
Ann Marshall, (410) 786-3059, for issues related to chronic care
management.
Marianne Myers, (410) 786-5962, for issues related to ambulance
extender provisions.
Amy Gruber, (410) 786-1542, for issues related to changes in
geographic area designations for ambulance payment.
Anne Tayloe-Hauswald, (410) 786-4546, for issues related to
clinical lab fee schedule.
Corinne Axelrod, (410) 786-5620, for issues related to Rural Health
Clinics or Federally Qualified Health Centers.
Renee Mentnech, (410) 786-6692, for issues related to access to
identifiable data for the Centers for Medicare & Medicaid models.
Marie Casey, (410) 786-7861 or Karen Reinhardt, (410) 786-0189, for
issues related to local coverage determination process for clinical
diagnostic laboratory tests.
Frederick Grabau, (410) 786-0206, for issues related to private
contracting/opt-out.
David Walczak, (410) 786-4475, for issues related to payment policy
for substitute physician billing arrangements (locum tenens).
Melissa Heesters, (410) 786-0618, for issues related to reports of
payments or other transfers of value to covered recipients.
Alesia Hovatter, (410) 786-6861, for issues related to physician
compare.
Christine Estella, (410) 786-0485, for issues related to the
physician quality reporting system.
Alexandra Mugge, (410) 786-4457, for issues related to EHR
incentive program.
Patrice Holtz, (410) 786-5663, for issues related to comprehensive
primary care initiative.
Terri Postma, (410) 786-4169, for issues related to Medicare Shared
Savings Program.
Kimberly Spalding Bush, (410) 786-3232, for issues related to
value-based modifier and improvements to physician feedback.
Elizabeth Holland, (410) 786-1309, Medicare EHR Incentive Program
(Medicare payment adjustments and hardship exceptions).
Elisabeth Myers (CMS), (410) 786-4751, Medicare EHR Incentive
Program (Medicare payment adjustments and hardship exceptions).
SUPPLEMENTARY INFORMATION:
Inspection of Public Comments: All comments received before the
close of
[[Page 67549]]
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
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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
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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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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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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
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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
[[Page 67745]]
bulletin provides the delineations of all Metropolitan Statistical
Areas, Metropolitan Divisions, Micropolitan Statistical Areas, Combined
Statistical Areas, and New England City and Town Areas in the United
States and Puerto Rico based on the standards published on June 28,
2010, in the Federal Register (75 FR 37246-37252) and Census Bureau
data.'' OMB defines an MSA as a CBSA associated with at least one
urbanized area that has a population of at least 50,000, and a
Micropolitan Statistical Area (referred to in this discussion as a
Micropolitan Area) as a CBSA associated with at least one urban cluster
that has a population of at least 10,000 but less than 50,000 (75 FR
37252). Counties that do not qualify for inclusion in a CBSA are deemed
``Outside CBSAs.'' We note that, when referencing the new OMB
geographic boundaries of statistical areas, we are using the term
``delineations'' consistent with OMB's use of the term (75 FR 37249).
Although the revisions OMB published on February 28, 2013 are not
as sweeping as the changes made when we adopted the CBSA geographic
designations for CY 2007, the February 28, 2013 OMB bulletin does
contain a number of significant changes. For example, we stated in the
CY 2015 PFS proposed rule (79 FR 40373) that if we adopt the revised
OMB delineations, there would be new CBSAs, urban counties that would
become rural, rural counties that would become urban, and existing
CBSAs that would be split apart. We have reviewed our findings and
impacts relating to the new OMB delineations, and find no compelling
reason to further delay implementation. We stated in the proposed rule
that we believe it is important for the ambulance fee schedule to use
the latest labor market area delineations available as soon as
reasonably possible to maintain a more accurate and up-to-date payment
system that reflects the reality of population shifts.
Additionally, in the FY 2015 IPPS proposed rule (79 FR 28055), we
also proposed to adopt OMB's revised delineations to identify urban
areas and rural areas for purposes of the IPPS wage index. This
proposal was finalized in the FY 2015 IPPS final rule (79 FR 49952).
For the reasons discussed above, we believe it would be appropriate to
adopt the same geographic area delineations for use under the ambulance
fee schedule as are used under the IPPS and other Medicare payment
systems. Thus, we proposed to implement the new OMB delineations as
described in the February 28, 2013 OMB Bulletin No. 13-01 beginning in
CY 2015 to more accurately identify urban and rural areas for ambulance
fee schedule payment purposes. We believe that the updated OMB
delineations more realistically reflect rural and urban populations,
and that the use of such delineations under the ambulance fee schedule
would result in more accurate payment. Under the ambulance fee
schedule, consistent with our current definitions of urban and rural
areas (Sec. 414.605), MSAs would continue to be recognized as urban
areas, while Micropolitan and other areas outside MSAs, and rural
census tracts within MSAs (as discussed below), would be recognized as
rural areas.
In addition to the OMB's statistical area delineations, the current
geographic areas used in the ambulance fee schedule also are based on
rural census tracts determined under the most recent version of the
Goldsmith Modification. These rural census tracts are considered rural
areas under the ambulance fee schedule (see Sec. 414.605). For certain
rural add-ons, section 1834(l) of the Act requires that we use the most
recent version of the Goldsmith Modification to determine rural census
tracts within MSAs. In the CY 2007 PFS final rule (71 FR 69714 through
69716), we adopted the most recent (at that time) version of the
Goldsmith Modification, designated as Rural-Urban Commuting Area (RUCA)
codes. RUCA codes use urbanization, population density, and daily
commuting data to categorize every census tract in the country. For a
discussion about RUCA codes, we refer the reader to the CY 2007 PFS
final rule (71 FR 69714 through 69716). As stated previously, on
February 28, 2013, OMB issued OMB Bulletin No. 13-01, which established
revised delineations for Metropolitan Statistical Areas, Micropolitan
Statistical Areas, and Combined Statistical Areas, and provided
guidance on the use of the delineations of these statistical areas.
Several modifications of the RUCA codes were necessary to take into
account updated commuting data and the revised OMB delineations. We
refer readers to the U.S. Department of Agriculture's Economic Research
Service Web site for a detailed listing of updated RUCA codes found at
http://www.ers.usda.gov/data-products/rural-urban-commuting-area-codes.aspx. The updated RUCA code definitions were introduced in late
2013 and are based on data from the 2010 decennial census and the 2006-
10 American Community Survey. We proposed to adopt the most recent
modifications of the RUCA codes beginning in CY 2015, to recognize
levels of rurality in census tracts located in every county across the
nation, for purposes of payment under the ambulance fee schedule. In
the CY 2015 PFS proposed rule (79 FR 40373), we stated that if we adopt
the most recent RUCA codes, many counties that are designated as urban
at the county level based on population would have rural census tracts
within them that would be recognized as rural areas through our use of
RUCA codes.
As we stated in the CY 2015 PFS proposed rule (79 FR 40373 through
40374), the 2010 Primary RUCA codes are as follows:
(1) Metropolitan area core: primary flow with an urbanized area
(UA).
(2) Metropolitan area high commuting: primary flow 30 percent or
more to a UA.
(3) Metropolitan area low commuting: primary flow 10 to 30 percent
to a UA.
(4) Micropolitan area core: primary flow within an Urban Cluster of
10,000 to 49,999 (large UC).
(5) Micropolitan high commuting: primary flow 30 percent or more to
a large UC.
(6) Micropolitan low commuting: primary flow 10 to 30 percent to a
large UC.
(7) Small town core: primary flow within an Urban Cluster of 2,500
to 9,999 (small UC).
(8) Small town high commuting: primary flow 30 percent or more to a
small UC.
(9) Small town low commuting: primary flow 10 to 30 percent to a
small UC.
(10) Rural areas: primary flow to a tract outside a UA or UC.
Based on this classification, and consistent with our current
policy (71 FR 69715), we proposed to continue to designate any census
tracts falling at or above RUCA level 4.0 as rural areas for purposes
of payment for ambulance services under the ambulance fee schedule. As
discussed in the CY 2007 PFS final rule (71 FR 69715), the Office of
Rural Health Policy within the Health Resources and Services
Administration (HRSA) determines eligibility for its rural grant
programs through the use of the RUCA code methodology. Under this
methodology, HRSA designates any census tract that falls in RUCA level
4.0 or higher as a rural census tract. In addition to designating any
census tracts falling at or above RUCA level 4.0 as rural areas, under
the updated RUCA code definitions, HRSA has also designated as rural
census tracts those census tracts with RUCA codes 2 or 3 that are at
least 400 square miles in area with a population density of no more
than 35 people. We refer readers to
[[Page 67746]]
HRSA's Web site: ftp://ftp.hrsa.gov/ruralhealth/Eligibility2005.pdf for
additional information. Consistent with the HRSA guidelines discussed
above, we proposed, beginning in CY 2015, to designate as rural areas
(1) those census tracts that fall at or above RUCA level 4.0, and (2)
those census tracts that fall within RUCA levels 2 or 3 that are at
least 400 square miles in area with a population density of no more
than 35 people. We stated in the CY 2015 PFS proposed rule (79 FR
40374) that we continue to believe that HRSA's guidelines accurately
identify rural census tracts throughout the country, and thus would be
appropriate to apply for ambulance payment purposes. We invited
comments on this proposal.
We stated in the CY 2015 PFS proposed rule (79 FR 40374) that the
adoption of the most current OMB delineations and the updated RUCA
codes would affect whether certain areas are recognized as rural or
urban. The distinction between urban and rural is important for
ambulance payment purposes because urban and rural transports are paid
differently. The determination of whether a transport is urban or rural
is based on the point of pick-up for the transport, and thus a
transport is paid differently depending on whether the point of pick-up
is in an urban or a rural area. During claims processing, a geographic
designation of urban, rural, or super rural is assigned to each claim
for an ambulance transport based on the point of pick-up ZIP code that
is indicated on the claim.
Currently, section 1834(l)(12) of the Act (as amended by section
104(b) of the PAMA) specifies that, for services furnished during the
period July 1, 2004 through March 31, 2015, the payment amount for the
ground ambulance base rate is increased by a ``percent increase''
(Super Rural Bonus) where the ambulance transport originates in a
``qualified rural area,'' which is a rural area that we determine to be
in the lowest 25th percentile of all rural populations arrayed by
population density (also known as a ``super rural area''). We implement
this Super Rural Bonus in Sec. 414.610(c)(5)(ii). We stated in the CY
2015 PFS proposed rule (79 FR 40374) that adoption of the revised OMB
delineations and the updated RUCA codes would have no negative impact
on ambulance transports in super rural areas, as none of the current
super rural areas would lose their status due to the revised OMB
delineations and the updated RUCA codes.
As we stated in the CY 2015 PFS proposed rule (79 FR 40374), the
adoption of the new OMB delineations and the updated RUCA codes would
affect whether or not transports would be eligible for other rural
adjustments under the ambulance fee schedule statute and regulations.
For ground ambulance transports where the point of pick-up is in a
rural area, the mileage rate is increased by 50 percent for each of the
first 17 miles (Sec. 414.610(c)(5)(i)). For air ambulance services
where the point of pick-up is in a rural area, the total payment (base
rate and mileage rate) is increased by 50 percent (Sec.
414.610(c)(5)(i)). Furthermore, under section 1834(l)(13) of the Act
(as amended by section 104(a) of the PAMA), for ground ambulance
transports furnished through March 31, 2015, transports originating in
rural areas are paid based on a rate (both base rate and mileage rate)
that is 3 percent higher than otherwise is applicable. (See also Sec.
414.610(c)(1)(ii)).
We stated in the CY 2015 PFS proposed rule (79 FR 40374) that if we
adopt OMB's revised delineations and the updated RUCA codes, ambulance
providers and suppliers that pick up Medicare beneficiaries in areas
that would be Micropolitan or otherwise outside of MSAs based on OMB's
revised delineations or in a rural census tract of an MSA based on the
updated RUCA codes (but are currently within urban areas) may
experience increases in payment for such transports because they may be
eligible for the rural adjustment factors discussed above, while those
ambulance providers and suppliers that pick up Medicare beneficiaries
in areas that would be urban based on OMB's revised delineations and
the updated RUCA codes (but are currently in Micropolitan Areas or
otherwise outside of MSAs, or in a rural census tract of an MSA) may
experience decreases in payment for such transports because they would
no longer be eligible for the rural adjustment factors discussed above.
The use of the revised OMB delineations and the updated RUCA codes
would mean the recognition of new urban and rural boundaries based on
the population migration that occurred over a 10-year period, between
2000 and 2010. In the CY 2015 PFS proposed rule (79 FR 40374), we
stated that, based on the latest United States Postal Service (USPS)
ZIP code file, there are a total of 42,914 ZIP codes in the U.S. We
stated in the proposed rule that the geographic designations for
approximately 99.48 percent of ZIP codes would be unchanged by OMB's
revised delineations and the updated RUCA codes, and that a similar
number of ZIP codes would change from rural to urban (122, or 0.28
percent) as would change from urban to rural (100, or 0.23 percent). We
stated in the proposed rule that, in general, it was expected that
ambulance providers and suppliers in 100 ZIP codes within 11 states may
experience payment increases if we adopt the revised OMB delineations
and the updated RUCA codes, as these areas would be redesignated from
urban to rural. We stated that the state of Ohio would have the most
ZIP codes changing from urban to rural with a total of 40, or 2.69
percent. We also stated in the CY 2015 PFS proposed rule that ambulance
providers and suppliers in 122 ZIP codes within 22 states may
experience payment decreases if we adopt the revised OMB delineations
and the updated RUCA codes, as these areas would be redesignated from
rural to urban. We stated that the state of West Virginia would have
the most ZIP codes changing from rural to urban (17, or 1.82 percent),
while Connecticut would have the greatest percentage of ZIP codes
changing from rural to urban (15 ZIP codes, or 3.37 percent). Our
findings were illustrated in Table 17 of the CY 2015 PFS proposed rule
(79 FR 40375).
We stated in the CY 2015 PFS proposed rule (79 FR 40375 and 40376)
that we believe the most current OMB statistical area delineations,
coupled with the updated RUCA codes, more accurately reflect the
contemporary urban and rural nature of areas across the country, and
that use of the most current OMB delineations and RUCA codes under the
ambulance fee schedule would enhance the accuracy of ambulance fee
schedule payments. We solicited comments on our proposal to implement
the new OMB delineations and the updated RUCA codes as discussed above
beginning in CY 2015, for purposes of payment under the Medicare
ambulance fee schedule.
We received four comments from two associations representing
ambulance service providers and suppliers and two ambulance suppliers
on our proposal to implement the new OMB delineations and the updated
RUCA codes for purposes of payment under the Medicare ambulance fee
schedule. Those comments are summarized below along with our responses.
Comment: All of the commenters agreed with CMS that it is
appropriate to adjust the geographic area designations periodically so
that the ambulance fee schedule reflects population shifts.
Response: We appreciate the support of the commenters.
Comment: Commenters expressed concern that the analysis of the
proposed modification in the CY 2015 PFS proposed rule did not describe
the actual impact of the proposed change
[[Page 67747]]
because it did not take into account the most recent modifications to
the RUCA codes. When these codes are applied, the commenters stated
that there would be substantially more ZIP codes that would shift. The
commenters estimated that more than 1,500 ZIP codes would shift from
rural to urban and about three times the number of ZIP codes identified
in the proposed rule would change from urban to rural. The commenters
also stated that some ZIP codes would no longer have super rural
status.
Response: The commenters are correct that the analysis published in
the CY 2015 PFS proposed rule (see Table 17 (79 FR 40375)) presented
the impact of the revised OMB delineations only and did not include the
impact of the updated RUCA codes. We did not receive the ZIP code
approximation of the 2010 RUCA codes file in time to be included in our
analysis in the proposed rule.
We have completed an updated analysis of both the revised OMB
delineations and the updated RUCA codes. Based on the latest United
States Postal Service (USPS) ZIP code file, there are a total of 42,918
ZIP codes in the U.S. Based on our updated analysis, we have concluded
that the geographic designations for approximately 92.02 percent of ZIP
codes would be unchanged by OMB's revised delineations and the updated
RUCA codes. There are more ZIP codes that would change from rural to
urban (3,038 or 7.08 percent) than from urban to rural (387 or 0.90
percent). The differences in the data provided in the proposed rule
compared to the final rule are due to inclusion of the updated RUCA
codes. In general, it is expected that ambulance providers and
suppliers in 387 ZIP codes within 41 states, may experience payment
increases under the revised OMB delineations and the updated RUCA
codes, as these areas have been redesignated from urban to rural. The
state of California has the most ZIP codes changing from urban to rural
with a total of 43, or 1.58 percent. Ambulance providers and suppliers
in 3,038 ZIP codes within 46 states and Puerto Rico may experience
payment decreases under the revised OMB delineations and the updated
RUCA codes, as these areas have been redesignated from rural to urban.
The state of Pennsylvania has the most ZIP codes changing from rural to
urban (293, or 13.06 percent), while West Virginia has the greatest
percentage of ZIP codes changing from rural to urban (269 ZIP codes, or
28.74 percent). Our findings are illustrated in Table 47.
BILLING CODE 4120-01-P
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BILLING CODE 4120-01-C
As discussed above, in the CY 2015 PFS proposed rule (79 FR 40374),
we proposed to designate as rural those census tracts that fall in RUCA
codes 2 or 3 that are at least 400 square miles in area with a
population density of no more than 35 people. However, upon further
analysis, we have determined that it is not feasible to implement this
proposal. Payment under the ambulance fee schedule is based on the ZIP
codes; therefore, if the ZIP code is predominantly metropolitan but has
some rural census tracts, we do not split the ZIP code areas to
distinguish further granularity to provide different payments within
the same ZIP code. We believe that payment for all ambulance
transportation services at the ZIP code level provides a consistent
payment system. Therefore, such census tracts were not considered rural
areas in the updated analysis set forth above.
For more detail on the impact of these changes, in addition to
Table 47, the following files are available through the Internet on the
AFS Web site at http://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/AmbulanceFeeSchedule/index.html: ZIP codes by state that
changed from urban to rural, ZIP codes by state that changed from rural
to urban, list of ZIP codes with RUCA code designations, and a complete
list of ZIP codes identifying their designation as super rural, rural
or urban.
As reflected in Table 47, our findings are generally consistent
with the commenters' findings that more than 1,500 ZIP codes would
change from rural to urban (our updated analysis indicates that 3,038
ZIP codes are changing), and that about three times the number of ZIP
codes identified in the proposed rule (100) would change from urban to
rural (our updated analysis indicates 387 ZIP codes are changing).
As we stated in the proposed rule (79 FR 40374), none of the
current super rural areas will lose their super rural status upon
implementation of the revised OMB delineations and the updated RUCA
codes.
Comment: One commenter suggested that we delay the implementation
of the adjustment until CY 2016 to allow CMS sufficient time to publish
the changes in
[[Page 67750]]
rural and urban status and allow all interested parties to provide
comments on the proposal. In addition to delaying implementation, the
commenter suggested implementing a 4-year transition that would phase-
in the payment reduction over a specified period for those ZIP codes
losing rural status.
Other commenters requested that the implementation of the
geographic adjustments outlined in the proposed rule be delayed until
such time as the data is available to complete a full and accurate
analysis of the ZIP codes affected and the financial impact to
industry. Absent such a delay, the commenters stated that the final
rule must clarify, in a complete and transparent manner, the accuracy
of the analysis used in the proposed rule.
Response: We believe that ambulance providers and suppliers had
sufficient notice of and opportunity to comment on the proposed
adoption of the revised OMB delineations and the updated RUCA codes
under the ambulance fee schedule, and thus we do not believe a delay in
implementation is warranted. In the proposed rule, we proposed to adopt
the revised OMB delineations as set forth in OMB Bulletin No. 13-01 and
the updated RUCA codes for purposes of payment under the ambulance fee
schedule consistent with the policy we implemented in CY 2007 (see the
CY 2007 PFS final rule (71 FR 69713 through 69716)). We explained in
the proposed rule that the adoption of the revised OMB delineations and
updated RUCA codes would affect the urban/rural designation of certain
areas, and thus would affect whether transports in certain areas would
be eligible for rural adjustments under the ambulance fee schedule. In
addition, OMB Bulletin No. 13-01was available on February 28, 2013, and
contained additional information regarding the changes in OMB
geographic area delineations. As discussed above, the ZIP code analysis
set forth in the proposed rule reflected the impact of the revised OMB
delineations. The 2010 RUCA codes and definitions were available on
December 31, 2013 on the U.S. Department of Agriculture's Economic
Research Service's Web site, which provided ambulance providers and
suppliers with additional information regarding changes to the level of
rurality in census tracts. Furthermore, section 1834(l) requires that
we use the most recent modification of the Goldsmith Modification to
determine rural census tracts for purposes of certain rural add-ons,
and our established policy, as set forth in Sec. 414.605, is that
rural areas include rural census tracts as determined under the most
recent version of the Goldsmith modification.
As discussed above and in the CY 2015 PFS proposed rule, we believe
the most current OMB statistical area delineations, coupled with the
updated RUCA codes, more accurately reflect the contemporary urban and
rural nature of areas across the country, and thus we believe the use
of the most current OMB delineations and RUCA codes under the ambulance
fee schedule will enhance the accuracy of ambulance fee schedule
payments. We believe that it is important to use the most current OMB
delineations and RUCA codes available as soon as reasonably possible to
maintain a more accurate and up-to-date payment system that reflects
the reality of population shifts. Because we believe the revised OMB
delineations and updated RUCA codes more accurately identify urban and
rural areas and enhance the accuracy of the Medicare ambulance fee
schedule, we do not believe a delay in implementation or a transition
period would be appropriate. Areas that lose their rural status and
become urban have become urban because of recent population shifts. We
believe it is important to base payment on the most accurate and up-to-
date geographic area delineations available. Furthermore, we believe a
delay would disadvantage the ambulance providers or suppliers
experiencing payment increases based on these updated and more accurate
OMB delineations and RUCA codes.
Finally, given the relatively small percentage of ZIP codes
affected by the revised OMB delineations and updated RUCA codes (a
total of 3,425 ZIP codes changing their urban/rural status out of
42,918 ZIP codes, or 7.98 percent), we do not believe that a delay is
warranted. As commenters requested, we have included in Table 47 our
updated analysis of the impact of adopting the revised OMB delineations
and the updated RUCA codes.
Comment: One commenter recommended that if any ZIP codes would lose
their super rural status as a result of the proposed adoption of the
revised OMB delineations and the updated RUCA codes, then CMS should
grandfather the current super rural ZIP codes. Another commenter stated
that the ambulance providers must have verification from CMS that the
super rural ZIP codes will not be affected by the changes described in
the proposed rule in advance of their implementation in the final rule.
Response: As we stated previously, the adoption of the OMB's
revised delineations and the updated RUCA codes will have no negative
impact on ambulance transports in super rural areas, as none of the
current super rural areas will lose their status upon implementation of
the revised OMB delineations and the updated RUCA codes. Current areas
designated as super rural areas will continue to be eligible for the
super rural bonus.
After consideration of the public comments received, and for the
reasons discussed above, we are finalizing our proposals to adopt,
beginning in CY 2015, the revised OMB delineations as set forth in
OMB's February 28, 2013 bulletin (No. 13-01) and the most recent
modifications of the RUCA codes for purposes of payment under the
ambulance fee schedule. As we proposed, using the updated RUCA codes
definitions, we will continue to designate any census tracts falling at
or above RUCA level 4.0 as rural areas. However, as discussed above, we
are not finalizing our proposal to designate as rural those census
tracts that fall within RUCA codes 2 or 3 that are at least 400 square
miles in area with a population density of no more than 35 people.
Finally, as discussed above, none of the current super rural areas will
lose their super rural status upon implementation of the revised OMB
delineations and the updated RUCA codes.
C. Clinical Laboratory Fee Schedule
In the CY 2014 PFS final rule with comment period (78 FR 74440
through 74445, 74820), we finalized a process under which we would
reexamine the payment amounts for test codes on the Clinical Laboratory
Fee Schedule (CLFS) for possible payment revision based on
technological changes beginning with the CY 2015 proposed rule, and we
codified this process at Sec. 414.511. After we finalized this
process, the Congress enacted the PAMA. Section 216 of the PAMA creates
new section 1834A of the Act, which requires us to implement a new
Medicare payment system for clinical diagnostic laboratory tests based
on private payor rates. Section 216 of the PAMA also rescinds the
statutory authority in section 1833(h)(2)(A)(i) of the Act for
adjustments based on technological changes for tests furnished on or
after April 1, 2014 (PAMA's enactment date). As a result of these
provisions, we did not propose any revisions to payment amounts for
test codes on the CLFS based on technological changes, and we proposed
to remove Sec. 414.511.
We did not receive any public comments on this proposal. Therefore,
we are finalizing our proposal to remove Sec. 414.511. In addition, we
will establish through rulemaking the parameters for
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the collection of private payor rate information and other requirements
to implement section 216 of the PAMA.
D. Removal of Employment Requirements for Services Furnished ``Incident
to'' Rural Health Clinics (RHC) and Federally Qualified Health Center
(FQHC) Visits
1. Background
Rural Health Clinics (RHCs) and Federally Qualified Health Centers
(FQHCs) furnish physicians' services; services and supplies ``incident
to'' the services of physicians: Nurse practitioner (NP), physician
assistant (PA), certified nurse-midwife (CNM), clinical psychologist
(CP), and clinical social worker (CSW) services; and services and
supplies incident to the services of NPs, PAs, CNMs, CPs, and CSWs.
They may also furnish diabetes self-management training and medical
nutrition therapy (DSMT/MNT), transitional care management services,
and in some cases, visiting nurse services furnished by a registered
professional nurse or a licensed practical nurse. (For additional
information on coverage requirements for services furnished in RHCs and
FQHCs, see Chapter 13 of the CMS Benefit Policy Manual.)
In the May 2, 2014 final rule with comment period entitled
``Prospective Payment System for Federally Qualified Health Centers;
Changes to Contracting Policies for Rural Health Clinics; and Changes
to Clinical Laboratory Improvement Amendments of 1988 Enforcement
Actions for Proficiency Testing Referral'' (79 FR 25436), we removed
the regulatory requirements that NPs, PAs, CNMs, CSWs, and CPs
furnishing services in a RHC must be employees of the RHC. RHCs are now
allowed to contract with NPs, PAs, CNMs, CSWs, and CPs, as long as at
least one NP or PA is employed by the RHC, as required under clause
(iii) in the first sentence of the flush material following
subparagraph (K) of section 1861(aa)(2) of the Act.
Services furnished in RHCs and FQHCs by nurses, medical assistants,
and other auxiliary personnel are considered ``incident to'' a RHC or
FQHC visit furnished by a RHC or FQHC practitioner. Sections
405.2413(a)(6), 405.2415(a)(6), and 405.2452(a)(6) currently state that
services furnished incident to an RHC or FQHC visit must be furnished
by an employee of the RHC or FQHC. Since there is no separate benefit
under Medicare law that specifically authorizes payment to nurses,
medical assistants, and other auxiliary personnel for their
professional services, they cannot bill the program directly and
receive payment for their services, and can only be remunerated when
furnishing services to Medicare patients in an ``incident to''
capacity.
To provide RHCs and FQHCs with as much flexibility as possible to
meet their staffing needs, we proposed to revise Sec. 405.2413(a)(5),
Sec. 405.2415(a)(5) and Sec. 405.2452(a)(5) and delete Sec.
405.2413(a)(6), Sec. 405.2415(a)(6) and Sec. 405.2452(a)(6) to remove
the requirement that services furnished incident to an RHC or FQHC
visit must be furnished by an employee of the RHC or FQHC, in order to
allow nurses, medical assistants, and other auxiliary personnel to
furnish ``incident to'' services under contract in RHCs and FQHCs. We
believe that removing the requirements will provide RHCs and FQHCs with
additional flexibility without adversely impacting the quality or
continuity of care.
We received 23 comments on our proposal. The following is a summary
of the comments received.
Comment: Most commenters were strongly in favor of removing these
employment requirements. Several commenters stated that this
flexibility will assist RHCs and FQHCs in increasing access to care,
enable them to recruit highly qualified health professionals, and fill
temporary staffing voids without adversely impacting the quality of
care. Some commenters expressed concerns about maintaining professional
standards, and others were concerned about the potential loss of
benefits for contracted staff.
A few commenters stated that they support removal of the employment
requirement, provided that RHC and FQHC auxiliary personnel are held to
the same high professional standards for the quality of care,
regardless of whether they are working under contract or as employees.
Commenters also added that all members of a physician-led health care
team should be enabled to perform medical interventions that they are
capable of performing according to their education, training,
licensure, and experience.
Response: The proposal to remove the requirement that auxiliary
workers in RHCs and FQHCs be employees of the RHC or FQHC does not
change either their professional standards of care or their scope of
practice. Nurses, medical assistants, and other auxiliary personnel are
expected to maintain their professional standards of care and furnish
services in adherence to their scope of practice, regardless of whether
they are employed or contracted by the RHC or FQHC.
Comment: Some commenters stated that although they understand the
need for greater staffing flexibility, they were concerned about the
potential loss of benefit packages to individuals that are contracted
and not employed. The commenters questioned whether the issue was
investigated or vetted, and how RHCs and FQHCs would compensate for
this loss of compensation for individuals providing incident to
services under contract rather than as an employee.
Response: We appreciate the concern that these commenters raised
regarding the potential loss of benefit packages for contracted
individuals; however, we do not regulate employment agreements or
benefit packages for individuals working at RHCs and FQHCs.
After consideration of the public comments, we are finalizing this
provision as proposed.
E. Access to Identifiable Data for the Center for Medicare and Medicaid
Innovation Models
1. Background and Statutory Authority
Section 3021 of the Affordable Care Act amended the Social Security
Act to include a new section 1115A, which established the Center for
Medicare and Medicaid Innovation (Innovation Center). Section 1115A
tasks the Innovation Center with testing innovative payment and service
delivery models that could reduce program expenditures while preserving
and/or enhancing the quality of care furnished to individuals under
titles XVIII, XIX, and XXI of the Act. The Secretary is also required
to conduct an evaluation of each model tested.
Evaluations will typically include quantitative and qualitative
methods to assess the impact of the model on quality of care and health
care expenditures. To comply with the statutory requirement to evaluate
all models conducted under section 1115A of the Act, we will conduct
rigorous quantitative analyses of the impact of the model test on
health care expenditures, as well as an assessment of measures of the
quality of care furnished under the model test. Evaluations will also
include qualitative analyses to capture the qualitative differences
between model participants, and to form the context within which to
interpret the quantitative findings. Through the qualitative analyses,
we will assess the experiences and perceptions of model participants,
providers, and individuals affected by the model.
In the evaluations we use advanced statistical methods to measure
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effectiveness. Our methods are intended to provide results that meet a
high standard of evidence, even when randomization is not feasible. To
successfully carry out evaluations of Innovation Center models, we must
be able to determine specifically which individuals are receiving
services from or are the subject of the intervention being tested by
the entity participating in the model test. Identification of such
individuals is necessary for a variety of purposes, including the
construction of control groups against which model performance can be
compared. In addition, to determine whether the observed impacts are
due to the model being tested and not due to differences between the
intervention and comparison groups, our evaluations will have to
account for potential confounding factors at the individual level,
which will require the ability to identify every individual associated
with the model test, control or comparison groups, and the details of
the intervention at the individual level.
Evaluations will need to consider such factors as outcomes,
clinical quality, adverse effects, access, utilization, patient and
provider satisfaction, sustainability, potential for the model to be
applied on a broader scale, and total cost of care. Individuals
receiving services from or who are the subjects of the intervention
will be compared to clinically, socio-demographically, and
geographically similar matched individuals along various process,
outcome, and patient-reported measures. Research questions in a typical
evaluation will include, but are not limited to, the following:
Clinical Quality:
++ Did the model improve or have a negative impact on clinical
process measures, such as adherence to evidence-based guidelines? If
so, how, how much, and for which individuals?
++ Did the model improve or have a negative impact on clinical
outcome measures, such as mortality rates, and the incidence and
prevalence of chronic conditions? If so, how, how much, and for which
individuals?
++ Did the model improve or have a negative impact on access to
care? If so, how, how much, and for which individuals?
++ Did the model improve or have a negative impact on care
coordination among providers? If so, how, how much, and for which
individuals?
++ Did the model improve or have a negative impact on medication
management? If so, how, how much, and for which individuals?
Patient Experience:
++ Did the model improve or have a negative impact on patient-
provider communication? If so, how, how much, and for which
individuals?
++ Did the model improve or have a negative impact on patient
experiences of care, quality of life, or functional status? If so, how,
how much, and for which individuals?
Utilization/Expenditures:
++ Did the model result in decreased utilization of emergency
department visits, hospitalizations, and readmissions? If so how, how
much, and for which individuals?
++ Did the model result in increased utilization of physician or
pharmacy services? If so how, how much, and for which individuals?
++ Did the model result in decreased total cost of care? Were
changes in total costs of care driven by changes in utilization for
specific types of settings or health care services? What specific
aspects of the model led to these changes? Were any savings due to
improper cost-shifting to the Medicaid program?
To carry out this research we must have access to patient records
not generally available to us. As such, we proposed to exercise our
authority in section 1115A(b)(4)(B) of the Act to establish
requirements for states and other entities participating in the testing
of past, present, and future models under section 1115A of the Act to
collect and report information that we have determined is necessary to
monitor and evaluate such models. Thus, we proposed to require model
participants, and providers and suppliers working under the models
operated by such participants, to produce such individually
identifiable health information and such other information as the
Secretary identifies as being necessary to conduct the statutorily
mandated research described above. Such research will include the
monitoring and evaluation of such models. Further, we view engagement
with other payers, both public and private, as a critical driver of the
success of these models. CMS programs constitute only a share of any
provider's revenue. Therefore, efforts to improve quality and reduce
cost are more likely to be successful if efforts are aligned across
payers. Section 1115A of the Act specifically allows the Secretary of
Health and Human Services to consider, in selecting which models to
choose for testing, ``whether the model demonstrates effective linkage
with other public sector or private sector payers.'' Multi-payer
models, such as but not limited to the Comprehensive Primary Care
model, will conduct quality measurement across all patients regardless
of payer in order to maximize alignment and increase efficiency.
Construction of multi-payer quality measures requires the ability to
identify all individuals subject to the model test regardless of payer.
In addition, section 1115A also permits the Secretary to consider
models that allow states to test and evaluate systems of all-payer
payment reform for the medical care of residents of the state,
including dual eligible individuals. Under the State Innovation Model
(SIM), the Innovation Center is testing the ability for state
governments to accelerate transformation. The premise of the SIM
initiative is to support Governor-sponsored, multi-payer models that
are focused on public and private sector collaboration to transform the
state's payment and delivery system. States have policy and regulatory
authorities, as well as ongoing relationships with private payers,
health plans, and providers that can accelerate delivery system reform.
SIM models must impact the preponderance of care in the state and are
expected to work with public and private payers to create multi-payer
alignment. The evaluation of SIM will include all populations and
payers involved in the state initiative, which in many cases includes
private payers. The absence of identifiable data from private payers
would result in considerable limitations on the level of evaluation
conducted. Therefore, under this authority, we also proposed to require
the submission of identifiable health and utilization information for
patients of private payers treated by providers/suppliers participating
in the testing of a model under section 1115A of the Act when an
explicit purpose of the model test is to engage private sector payers.
This regulation will provide clear legal authority for Health Insurance
Portability and Accountability Act (HIPAA) Covered Entities to disclose
any required protected health information. Identifiable data submitted
by entities participating in the testing of models under section 1115A
of the Act will meet CMS Acceptable Risks Safeguards (ARS) guidelines.
When data is expected to be exchanged over the internet, such exchange
will also meet all E-Gov requirements. In accordance with the
requirements of the Privacy Act of 1974, upon receipt by CMS or its
contractors, these data will be covered under a CMS-established system
of records (System No. 09-70-0591), which serves as the Master system
for all demonstrations, evaluations, and research studies administered
by the Innovation Center. These data will be
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stored until the evaluation is complete and all necessary policy
deliberations have been finalized.
2. Provisions of the Proposed Regulations
Wherever possible, evaluations will make use of claims, assessment,
and enrollment data available through CMS' existing administrative
systems. However, evaluations will generally also need to include
additional data not available through existing CMS administrative
systems. As such, depending on the particular project, CMS or its
contractor will require the production of the minimum data necessary to
carry out the statutorily mandated research work described in section
E.1. of this final rule with comment period. Such data may include the
identities of the patients served under the model, relevant clinical
details about the services furnished and outcomes achieved, and any
confounding factors that might influence the evaluation results
achieved through the delivery of such services. For illustrative
purposes, below are examples of some of the types of information that
could be required to carry out an evaluation, and for which the
evaluator would need patient-level identifiers.
Utilization data not otherwise available through existing
Centers for Medicare & Medicaid Services (CMS) systems.
Beneficiary, patient, participant, family, and provider
experiences.
Beneficiary, patient, participant, and provider rosters
with identifiers that allow linkages across time and datasets.
Beneficiary, patient, participant, and family socio-
demographic and ethnic characteristics.
Care management details, such as details regarding the
provision of services, payments or goods to beneficiaries, patients,
participants, families, or other providers.
Beneficiary, patient, and participant functional status
and assessment data.
Beneficiary, patient, and participant health behaviors.
Clinical data, such as, but not limited to lab values and
information from EHRs.
Beneficiary, patient, participant quality data not
otherwise available through claims.
Other data relevant to identified outcomes--for example,
participant employment status, participant educational degrees pursued/
achieved, and income.
We invited public comment on this proposal to mandate the
production of the individually identifiable information necessary to
conduct the statutorily mandated research under section 1115A of the
Act.
In addition, we proposed a new subpart K in part 403 to implement
section 1115A of the Act.
The following is a summary of the comments we received regarding
our proposal to mandate the production of the individually identifiable
information necessary to conduct the statutorily mandated research
under section 1115A of the Act.
Comment: Commenters consistently recognized the need to evaluate
Innovation Center models as an important component of the effort to
test new payment and service delivery models. Further, several
commenters supported the need for rigorous evaluations that include
control groups. One commenter further recommended the Innovation Center
make the aggregated de-identified data from evaluations available to
external researchers. Although supportive of the need to evaluate
Innovation Center models, several commenters stated the Innovation
Center had not sufficiently justified the need for individually
identifiable patient information, and suggested aggregate or de-
identified data should be sufficient. One commenter suggested the
submission of performance rates, patient outcomes information, and/or
composite scores for participating providers instead of individual
patient-level data. The commenter further stated that CMS should not
have access to proprietary patient-level data in registries. Some of
the commenters stated CMS should publish its evaluation methodologies
and solicit feedback from independent research experts as to the need
for patient-level data.
Response: We appreciate the commenters' support for rigorous
evaluations, and understand the desire for access to the aggregate de-
identified data from these evaluations. We always make our data
available in accordance with applicable law, HHS and CMS policies, and,
where relevant, the availability of funding. Such laws include HIPAA,
the Privacy Act, the Trade Secrets Act and the Freedom of Information
Act. With respect to comments recommending the use of aggregate or de-
identified data instead of individually identifiable data, as we
discussed in the preamble of the proposed rule, we believe individually
identifiable data is necessary. As noted in this final rule with
comment and in the preamble of our proposed rule, evaluations will need
to consider such factors as outcomes, clinical quality, adverse
effects, access, utilization, patient and provider satisfaction,
sustainability, potential for the model to be applied on a broader
scale, and total cost of care. Furthermore, individuals receiving
services from or who are the subjects of the intervention will be
compared to clinically, socio-demographically, and geographically
similar matched individuals along various process, outcome, and
patient-reported measures. Many of these assessments will require
person-level data. We will make use of aggregate information on system
performance through the use of provider submitted aggregate performance
rates for selected measures, patient outcomes information, and/or
composite scores. However, without the ability to identify specifically
which beneficiaries are receiving services as a result of the model,
the evaluation analyses could include individuals not even subject to
the intervention, and therefore, there would be a very real possibility
that positive impacts of the model may be diluted and unobservable.
While aggregate data could be limited to the target population,
identification of which individuals are within the target population of
the model, are receiving items and services under the model, or are
subject to the interventions being tested under the model will also
allow the evaluators to construct matched comparison groups that look
as similar as possible to the intervention group. The absence of a
well-matched comparison group, which can only be achieved when
individually identifiable characteristics are known, could result in
impact estimates that are inaccurate because these impact estimates
could be due to differences between the intervention group and the
comparison group and not the intervention itself. Further, while we
will need to know the identifiers of beneficiaries that are the subject
of the model test, the submission of other patient-level data from
proprietary registries would be limited to data necessary to conduct a
credible evaluation. Data on individuals are also needed to assess
differential impacts among subgroups of beneficiaries to identify who
benefits most from the intervention. We agree it is important to seek
expert opinion on the structure of our assessment methods, and so these
models are developed in concert with and run through our evaluation
contractors, which are independent research firms and academic
institutions. Where needed, these contractors also reach out to
technical expert panels for added guidance. As a result, the design and
implementation of
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these assessments are informed by those with expertise in health
services research, economics, statistics, program evaluation,
epidemiology, and public health.
Comment: Although generally supportive of the need for rigorous
evaluations, some commenters worried that any requirement to provide
individually identifiable data for monitoring and/or assessment
purposes would impose an undue administrative burden on model
participants, and could lead to the need to submit large (and,
potentially, overbroad) amounts of individually identifiable patient-
level data. A few commenters suggested that the Innovation Center
should first look to other federal government sources before requesting
data from model participants. Several commenters noted that it would be
costly to produce patient-level data for models with a multi-payer
focus, and others stated additional payment should be made to model
participants to offset the cost of data reporting. Further, it was
suggested that CMS estimate the potential burden and cost on physicians
and other providers, and if found to be burdensome, give physicians the
right to opt out of producing information that may not be available due
to cost limitations or other administrative barriers, such as barriers
to producing data stored in electronic health records.
Response: We agree that our determination of what data are
necessary to evaluate a model should be made taking into consideration
the burden and cost associated with collecting and reporting such data,
including the complexities associated with abstracting data from
electronic health records. We further agree that in making such
determinations, we should take advantage of all existing federal data
systems, wherever possible so that we may minimize the amount of data
that we must obtain from model participants. Our regulation will only
require that model participants collect and report data as is necessary
for monitoring or evaluation; thus, if we do not need the data, we
would not seek to collect it from model participants.
Reimbursement may be considered for future models, but if adopted,
any such reimbursement, and any conditions for such reimbursement,
would be prominently noted in the solicitation or modifications to
model agreements. To the extent feasible, we also agree that it is
important for potential model participants to understand the data
collection requirements before the model begins, so that they may take
these requirements into consideration. We do not agree, though, that
model participants should be given the opportunity to opt out of
producing the required information, as this would undermine the
evaluation and skew results.
With respect to the specific data needed for evaluation purposes,
in many models, the evaluators will be able to determine who the
individuals are that are the subjects of the model test without the
need to obtain identifiers from the model participants. In those cases,
there is a beneficiary-specific payment under the model and the
evaluator can use our existing administrative data systems to identify
which beneficiaries are in the model. In this last example, although we
may not need to obtain the identifiers, we may still need to obtain
other person-level data, such as clinical information. In other models,
where a specific beneficiary-level payment is not being made, the
evaluation contractor will not have an ability to identify the
individuals targeted by the model participants. In this latter
circumstance, the participants will need to provide the identifiers
that would then be used by the evaluator to link to existing
administrative data systems. Although the exact data needs will vary by
model, in some cases we would determine that only the identifiers (such
as, but not limited to, the Medicare Health Insurance Claim number) are
required. In other circumstances, it is possible the evaluators will
need other data, such as clinical data not otherwise available in
claims to properly account for severity of disease. In this manner we
will limit data demands, and the attendant costs, to the data necessary
to accomplish the required monitoring and assessment.
Comment: Some commenters stated the requirement could result in
requests for data from providers tangentially involved in an Innovation
Center project to report any data the agency decides it needs. A few
commenters further stated the Innovation Center should ensure that all
participating entities seek patient authorizations to use their records
for the purpose of evaluating the model.
Response: Section 1115A(b)(4) of the Act authorizes us to establish
requirements for ``States and other entities participating in the
testing of models'' to collect and report data necessary for monitoring
and evaluating the models. Our regulation, therefore, establishes this
requirement only with respect to model participants. We consider model
participants to include any party that has agreed to participate in, or
that receives payment from us under, a model we are testing. In
response to the comment suggesting that the Innovation Center ensure
that all participating entities seek patient authorizations to use
their records for the purpose of evaluating the model, we decline to
impose such a requirement in implementing section 1115A(b)(4) of the
Act, and we refer such entities to their own legal counsel for advice
on whether any form of consent would be required by other applicable
law.
Comment: Some commenters stated the Innovation Center should
publish and be transparent about what the exact data reporting and
collection requirements would be so that participants would have notice
of what data they would be required to collect. Commenters stated that
without a notice and comment period as part of the model test, there
will be no opportunity for stakeholders to weigh in with their
perspective of what constitutes the minimum necessary information to
achieve the evaluation goals. A few commenters stated the Innovation
Center should first determine the specific data elements that are
required for evaluation purposes for the existing programs and this
information should be shared with participants who should, at minimum,
be given an opportunity to provide comment on the required inputs for
which they will be responsible as part of the evaluation. These
commenters also stated the Innovation Center should develop such
requirements in advance of the program start for participants to allow
them an opportunity to provide feedback and weigh the information as
part of their decision to participate in the model.
Response: We agree it is important to restrict data requests to the
data necessary to conduct credible monitoring and evaluation. We
frequently provide stakeholders the opportunity to weigh in on what
data they believe would be necessary to evaluate a model, generally
through webinars that we conduct during model development and
implementation. Further, in order for potential model participants to
understand the likely data reporting requirements, to the extent
feasible, these requirements are incorporated into the solicitation
process. However, we decline to adopt a requirement to undertake a
notice and comment process as part of our determination of what data
are necessary for monitoring or evaluation because we believe the
process already in place allows for model participant feedback. We also
disagree with commenters who recommend that we make the determination
and specify the particular data elements that will be required for
monitoring and evaluation prior to the start of the model. It is not
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always possible at that early stage of the model to know precisely what
data elements will be necessary. However, we will strive to provide as
much relevant detail as possible about data collection and reporting
requirements in any solicitation process and in any ongoing
communications with potential participants, and we will continue to
take any comments received into account in determining our data needs.
Comment: A few commenters stated that CMS has not provided
sufficient assurances that providers, in responding to these data
requests, would be protected or deemed to be in compliance with the
HIPAA requirements for the use and disclosure of protected health
information (PHI). These commenters stated the Innovation Center
reference to requiring reporting of individually identifiable patient-
level data raises significant privacy concerns for providers who would
be required to report such data. These commenters stated HIPAA requires
that providers limit the use and disclosure of personal health
information to the minimum necessary to accomplish the intended purpose
of the disclosure. These commenters stated the Innovation Center
requests for such data must be in compliance with providers' HIPAA
obligations. As such, some commenters stated CMS should work with the
Office for Civil Rights (OCR) to ensure providers reporting data as
part of an evaluation are doing so consistent with their HIPAA
obligations. These commenters stated it is HHS's Office for Civil
Rights (OCR)--not CMS--that ultimately determines whether a particular
provider is properly compliant and not subject to penalties. These same
commenters suggested that the Innovation Center should work with OCR to
issue OCR guidance stating that providers reporting data as part of an
evaluation are doing so consistent with their HIPAA obligations. Some
commenters stated CMS should consider the necessary data elements on a
program-by-program basis rather than establishing a blanket approval,
or at minimum limit the scope of the approved data requirements and
uses, and should provide clear instructions and other educational
resources to ensure that collection and reporting of the data complies
with the HIPAA Privacy and Security rules.
Response: We appreciate the concerns expressed about compliance
with the HIPAA requirements and the recommendation to work with OCR.
However, we respectfully disagree that sufficient assurances have not
been provided. The disclosure would be required by a regulation, so it
would be ``required by law'' under HIPAA. See 45 CFR 164.512(a) and the
definition of ``required by law'' at 45 CFR 164.103. A HIPAA covered
entity is permitted to disclose protected health information as
required by law under these provisions so long as the disclosure
complies with and is limited to the relevant requirements of the law. A
separate minimum data necessary determination is not required under the
HIPAA Privacy Rule for required by law disclosures under 45 CFR
164.512(a). See 45 CFR 164.502(b)(2). Although a separate minimum data
necessary determination is not required, as a policy matter and
consistent with the statutory authority under 1115A(b)(4), CMS will
only require that data we determine is necessary for evaluation and
monitoring of Innovation Center models.
Comment: Several commenters stated that collection of beneficiary-
level health information raises significant security concerns. Although
supportive of sharing relevant and medically necessary patient
information, one commenter raised a particular concern that some data
could be sensitive information related to mental health or substance
abuse. Some commenters stated CMS should adopt safeguards against
inappropriate use or disclosure of patient identifiable data.
Response: We agree that it is critical to abide by rigorous
security standards, and we take patient privacy seriously. As CMMI is
part of Fee-for-Service Medicare, a Health Care Component that is
subject to the HIPAA requirements, providers' and suppliers' data will
generally be subject to the same HIPAA privacy and security
requirements as that data was subject to in the hands of the providers
and suppliers from which it came. Furthermore, if stored in a manner
searchable by individual identifiers, it will also be subject to the
Privacy Act of 1974.
As HIPAA Business Associates, this data will be equally well
protected when held by one of our evaluation contractors. In addition,
the disclosure of substance abuse records will, where applicable, also
be subject to the Part 2 regulations.
Comment: One commenter stated CMS should not use these data for
purposes other than those articulated in the proposed rule, and that
the assessments should comply with the applicable statutory
requirements, meaning that: (1) The assessments should take into
account all of the factors outlined under section 1115A(b)(4) of the
Act (that is, quality of care, including patient-level outcomes and
patient-centeredness criteria); (2) the assessments should be made
publicly available; and (3) CMS should pursue notice-and-comment
rulemaking before any of the CMS demonstrations are expanded based on
these assessments, as required by section 1115A(c) of the Act.
Response: We agree that evaluations should assess quality of care,
and the patient-de-identified results should be made publicly
available, as required by section 1115A(b)(4) of the Act. We would
pursue model expansion according to the terms of the statute.
After consideration of the public comments we received, we are
finalizing our proposal to mandate the production of the individually
identifiable information necessary to conduct the statutorily mandated
research under section 1115A of the Act. We are accepting the
recommendations made by commenters to minimize participant burden, seek
input from providers, and use independent researchers. In addition, we
are finalizing our proposal to add a new subpart K in part 403 to
implement section 1115A of the Act without modification.
F. Local Coverage Determination Process for Clinical Diagnostic
Laboratory Testing
The CY 2015 proposed rule (79 FR 40378 through 40380), section
III.F., included discussion of a proposal to modify the existing
process used by the Medicare Administrative Contractors (MACs) in
developing local coverage determinations (LCDs) for clinical diagnostic
laboratory tests. Briefly, the proposal would have expedited the
timeline for LCD development for clinical diagnostic laboratory test
LCDs by reducing the calendar days for some of the steps and by making
optional or eliminating other steps within the current process. A
detailed discussion of the proposal is available in section III.F. of
the CY 2015 PFS Proposed Rule.
We would like to thank the numerous public commenters for their
time in submitting thoughtful comments to the agency on this issue.
Comments were received from individual members of the public, insurers,
drug manufacturers, medical specialty societies, laboratory groups and
individual laboratories. The commenters focused their comments on the
following issues: The proposal to reduce the draft LCD public comment
period to 30 days; the proposal for a meeting of the Carrier Advisory
Committee to be optional; the proposal to remove the requirement for a
public meeting; and the proposal to eliminate the 45-day notice period
prior to final
[[Page 67756]]
LCDs becoming effective. In addition, commenters were concerned about
the proposed changes in light of section 216 of the Protecting Access
to Medicare Act of 2014 (PAMA), titled ``Improving Medicare Policies
for Clinical Diagnostic Laboratory Tests.'' The comments received have
given the agency much to consider prior to moving forward with any
changes to the LCD process; therefore, we will not finalize any changes
to the LCD process in this final rule. We will explore the possibility
of future notice-and-comment rulemaking on this issue.
G. Private Contracting/Opt-Out
1. Background
Effective January 1, 1998, section 1802(b) of the Act permits
certain physicians and practitioners to opt-out of Medicare if certain
conditions are met, and to furnish through private contracts services
that would otherwise be covered by Medicare. For those physicians and
practitioners who opt-out of Medicare in accordance with section
1802(b) of the Act, the mandatory claims submission and limiting charge
rules of section 1848(g) of the Act would not apply. As a result, if
the conditions necessary for an effective opt-out are met, physicians
and practitioners are permitted to privately contract with Medicare
beneficiaries and to charge them without regard to Medicare's limiting
charge rules. Regulations governing the requirements and procedures for
private contracts appear at 42 CFR part 405, subpart D.
a. Opt-Out Determinations (Sec. 405.450)
The private contracting regulation at Sec. 405.450 describes
certain opt-out determinations made by Medicare, and the process that
physicians, practitioners, and beneficiaries may use to appeal those
determinations. Section 405.450(a) describes the process available for
physicians or practitioners to appeal Medicare enrollment
determinations related to opting out of the program, and Sec.
405.450(b) describes the process available to challenge payment
determinations related to claims for services furnished by physicians
who have opted out. Both provisions refer to Sec. 405.803, the Part B
claims appeals process that was in place at the time the opt-out
regulations were issued (November 2, 1998). When those regulations were
issued, a process for a physician or practitioner to appeal enrollment
related decisions had not been implemented in regulation. Thus, to
ensure an appeals process was available to physicians and practitioners
for opt-out related issues, we chose to utilize the existing claims
appeals process in Sec. 405.803 for both enrollment and claims related
appeals.
In May 16, 2012 Federal Register (77 FR 29002), we published a
final rule entitled ``Medicare and Medicaid Program; Regulatory
Provisions to Promote Program Efficiency, Transparency and Burden
Reduction.'' In that final rule, we deleted the provisions relating to
initial determinations, appeals, and reopenings of Medicare Part A and
Part B claims, and relating to determinations and appeals regarding an
individual's entitlement to benefits under Medicare Part A and Part B,
which were contained in part 405, subparts G and H (including Sec.
405.803) because these provisions were obsolete and had been replaced
by the regulations at part 405, subpart I. We inadvertently neglected
to revise the cross-reference in Sec. 405.450(a) and (b) of the
private contracting regulations to direct appeals of opt-out
determinations through the current appeal process. However, it is
important to note that our policy regarding the appeal of opt-out
determinations did not change when the appeal regulations at part 405,
subpart I were finalized.
The procedures set forth in current part 498 establish the appeals
procedures regarding decisions made by Medicare that affect enrollment
in the program. We believe this process, and not the appeal process in
part 405, subpart I, is the appropriate channel for physicians and
practitioners to challenge an enrollment related opt-out decision made
by Medicare. There are now two different sets of appeal regulations for
initial determinations; and the appeal of enrollment related opt-out
determinations is more like the types of determinations now addressed
under part 498 than those under part 405, subpart I. Specifically, the
appeal process under part 405, subpart I focuses on reviews of
determinations regarding beneficiary entitlement to Medicare and claims
for benefits for particular services. The appeal process under part 498
is focused on the review of determinations regarding the participation
or enrollment status of providers and suppliers. Enrollment related
opt-out determinations involve only the status of particular physician
or practitioners under Medicare, and do not involve beneficiary
eligibility or claims for specific services. As such, the appeal
process under part 498 is better suited for the review of enrollment
related opt-out determinations.
However, we do not believe the enrollment appeals process
established in part 498 is the appropriate mechanism for challenging
payment decisions on claims for services furnished by a physician and
practitioner who has opted out of the program. Appeals for such claims
should continue to follow the appeals procedures now set forth in part
405 subpart I.
b. Definitions, Requirements of the Opt Out Affidavit, Effects of
Opting Out of Medicare, Application to Medicare Advantage Contracts
(Sec. Sec. 405.400, 405.420(e), 405.425(a), and 405.455)
Section 405.400 sets forth certain definitions for purposes of the
private contracting regulations. Among the defined terms is ``Emergency
care services'' which means services furnished to an individual for
treatment of an ``emergency medical condition'' as that term is defined
in Sec. 422.2. The cross-referenced regulation at Sec. 422.2 included
within the definition of emergency care services was deleted on June
29, 2000 (65 FR 40314) and at that time we inadvertently neglected to
revise that cross-reference. The cross-reference within the definition
of emergency care services should have been amended at that time to
cite the definition of ``emergency services'' in Sec. 424.101.
The private contracting regulations at Sec. 405.420(e), Sec.
405.425(a) and Sec. 405.455 all use the term Medicare+Choice when
referring to Part C plans. However, we no longer use the term
Medicare+Choice when referring to Part C plans; instead the plans are
referred to as Medicare Advantage plans. When part 422 of the
regulations was updated on January 28, 2005 (70 FR 4741), we
inadvertently neglected to revise Sec. 405.420(e), Sec. 405.425(a)
and Sec. 405.455 to replace the term Medicare+Choice with Medicare
Advantage plan.
2. Provisions of the Proposed Regulation
For the reasons discussed above, we proposed that a determination
described in Sec. 405.450(a) (relating to the status of opt-out or
private contracts) is an initial determination for purposes of Sec.
498.3(b), and a physician or practitioner who is dissatisfied with a
Medicare determination under Sec. 405.450(a) may utilize the
enrollment appeals process currently available for providers and
suppliers in part 498. In addition, we proposed that a determination
described in Sec. 405.450(b) (that payment cannot be made to a
beneficiary for services furnished by a physician or practitioner who
has opted out) is an initial determination for the purposes of Sec.
405.924 and may be challenged through the existing claims appeals
procedures in part 405 subpart I. Accordingly, we proposed that the
cross
[[Page 67757]]
reference to Sec. 405.803 in Sec. 405.450(a) be replaced with a cross
reference to Sec. 498.3(b). We also proposed that the cross reference
to Sec. 405.803 in Sec. 405.450(b) be replaced with a cross reference
to Sec. 405.924. We also proposed corresponding edits to Sec.
498.3(b) and Sec. 405.924 to note that the determinations under Sec.
405.450(a) and (b), respectively, are initial determinations.
For the reasons discussed above, we also proposed that the
definition of Emergency care services at Sec. 405.400 be revised to
cite the definition of Emergency services in Sec. 424.101 and that all
references to Medicare+Choice in Sec. 405.420(e), Sec. 405.425(a) and
Sec. 405.455 be replaced with the term ``Medicare Advantage.''
The following is a summary of the comments we received regarding
our proposals.
Comment: Commenters requested that physicians and practitioners be
allowed to opt out of Medicare indefinitely instead of submitting a new
affidavit every 2 years.
Response: These comments are outside the scope of this rule as they
are not related to the proposed changes to the opt-out regulations.
Nevertheless, we note that section 1802(b)(3)(B)(ii) of the Act
specifies that the opt-out affidavit must provide that the ``physician
or practitioner will not submit any claim under this title for any item
or service provided to any medicare beneficiary. . . during the 2-year
period beginning on the date the affidavit is signed.'' As such, the
longest interval for which an opt-out can be effective is 2 years. We
have no authority to modify that statutory requirement.
Because we did not receive any comments on our proposals, we are
finalizing the rule as proposed.
H. Solicitation of Comments on the Payment Policy for Substitute
Physician Billing Arrangements
1. Background
In accordance with section 1842(b)(6) of the Act, no payment under
Medicare Part B may be made to anyone other than to the beneficiary to
whom a service was furnished or to the physician or other person who
furnished the service. However, there are certain limited exceptions to
this general prohibition. For example, section 1842(b)(6)(D) of the Act
describes an exception for substitute physician billing arrangements,
which states that ``payment may be made to a physician for physicians'
services (and services furnished incident to such services) furnished
by a second physician to patients of the first physician if (i) the
first physician is unavailable to provide the services; (ii) the
services are furnished pursuant to an arrangement between the two
physicians that (I) is informal and reciprocal, or (II) involves per
diem or other fee-for-time compensation for such services; (iii) the
services are not provided by the second physician over a continuous
period of more than 60 days or are provided over a longer continuous
period during all of which the first physician has been called or
ordered to active duty as a member of a reserve component of the Armed
Forces; and (iv) the claim form submitted to the [Medicare
Administrative contractor (MAC)] for such services includes the second
physician's unique identifier . . . and indicates that the claim meets
the requirements of this subparagraph for payment to the first
physician.'' Section 1842(b)(6) of the Act is self-implementing and we
have not interpreted the statutory provisions through regulations.
In practice, section 1842(b)(6)(D) of the Act generally allows for
two types of substitute physician billing arrangements: (1) An informal
reciprocal arrangement where doctor A substitutes for doctor B on an
occasional basis and doctor B substitutes for doctor A on an occasional
basis; and (2) an arrangement where the services of the substitute
physician are paid for on a per diem basis or according to the amount
of time worked. Substitute physicians in the second type of arrangement
are sometimes referred to as ``locum tenens'' physicians. It is our
understanding that locum tenens physicians are substitute physicians
who often do not have a practice of their own, are geographically
mobile, and work on an as-needed basis as independent contractors. They
are utilized by physician practices, hospitals, and health care
entities enrolled in Part B as Medicare suppliers to cover for
physicians who are absent for reasons such as illness, pregnancy,
vacation, or continuing medical education. Also, we have heard
anecdotally that locum tenens physicians are used to fill staffing
needs (for example, in physician shortage areas) or, on a temporary
basis, to replace physicians who have permanently left a medical group
or employer.
We are concerned about the operational and program integrity issues
that result from the use of substitute physicians to fill staffing
needs or to replace a physician who has permanently left a medical
group or employer. For example, although our Medicare enrollment rules
require physicians and physician groups or organizations to notify us
promptly of any enrollment changes (including reassignment changes)
(see Sec. 424.516(d)), processing delays or miscommunication between
the departing physician and his or her former medical group or employer
regarding which party would report the change to Medicare could result
in the Provider Transaction Access Number (PTAN) that links the
departed physician and his or her former medical group remaining
``open'' or ``attached'' for a period of time. During such period, both
the departed physician and the departed physician's former medical
group might bill Medicare under the departed physician's National
Provider Identifier (NPI) for furnished services. This could occur
where a substitute physician is furnishing services in place of the
departed physician in the departed physician's former medical group,
while the departed physician is also furnishing services to
beneficiaries following departure from the former group. Operationally,
either or both types of claims could be rejected or denied, even though
the claims filed by the departed physician were billed appropriately.
Moreover, the continued use of a departed physician's NPI to bill for
services furnished to beneficiaries by a substitute physician raises
program integrity issues, particularly if the departed physician is
unaware of his or her former medical group or employer's actions.
Finally, as noted above, section 1842(b)(6)(D)(iv) of the Act
requires that the claim form submitted to the MAC include the
substitute physician's unique identifier. Currently, the unique
identifier used to identify a physician is the physician's NPI. Prior
to the implementation of the NPI, the Unique Physician Identification
Number (UPIN) was used. Because a substitute physician's NPI is not
captured on the CMS-1500 claim form or on the appropriate electronic
claim, physicians and other entities that furnish services to
beneficiaries through the use of a substitute physician are required to
enter a modifier on the CMS-1500 claim form or on the appropriate
electronic claim indicating that the services were furnished by a
substitute physician; and to keep a record of each service provided by
the substitute physician, associated with the substitute physician's
UPIN or NPI; and to make this record available to the MAC upon request.
(See Medicare Claims
[[Page 67758]]
Processing Manual (Pub. 100-4), Chapter 1, Sections 30.2.10 and
30.2.11) However, having a NPI or UPIN does not necessarily mean that
the substitute physician is enrolled in the Medicare program. Without
being enrolled in Medicare, we do not know whether the substitute
physician has the proper credentials to furnish the services being
billed under section 1842(b)(6)(D) of the Act or if the substitute
physician is sanctioned or excluded from Medicare. The importance of
enrollment and the resulting transparency afforded the Medicare program
and its beneficiaries was recognized by the Congress when it included
in the Affordable Care Act a requirement that physicians and other
eligible non-physician practitioners (NPPs) enroll in the Medicare
program if they wish to order or refer certain items or services for
Medicare beneficiaries. This includes those physicians and other
eligible NPPs who do not and will not submit claims to a Medicare
contractor for the services they furnish. We solicited comments
regarding how to achieve similar transparency in the context of
substitute physician billing arrangements for the identity of the
individual actually furnishing the service to a beneficiary.
2. Analysis of Comments
To help inform our decision whether and, if so, how to address the
issues discussed in section III.H.1., and whether to adopt regulations
interpreting section 1842(b)(6)(D) of the Act, we solicited comments on
the policy for substitute physician billing arrangements. We noted that
any regulations would be proposed in a future rulemaking with
opportunity for public comment. Through this solicitation, we hoped to
understand better current industry practices for the use of substitute
physicians and the impact that policy changes limiting the use of
substitute physicians might have on beneficiary access to physician
services.
We received a few comments on the issues raised in this
solicitation. We thank the commenters for their input, and we will
carefully consider their comments in any future rulemaking on this
subject.
I. Reports of Payments or Other Transfers of Value to Covered
Recipients
1. Background
In the February 8, 2013 Federal Register (78 FR 9458), we published
the ``Transparency Reports and Reporting of Physician Ownership or
Investment Interests'' final rule which implemented section 1128G of
the Social Security Act (``Act''), as added by section 6002 of the
Affordable Care Act. Under section 1128G(a)(1) of the Act,
manufacturers of covered drugs, devices, biologicals, and medical
supplies (applicable manufacturers) are required to submit on an annual
basis information about certain payments or other transfers of value
made to physicians and teaching hospitals (collectively called covered
recipients) during the course of the preceding calendar year. Section
1128G(a)(2) of the Act requires applicable manufacturers and applicable
group purchasing organizations (GPOs) to disclose any ownership or
investment interests in such entities held by physicians or their
immediate family members, as well as information on any payments or
other transfers of value provided to such physician owners or
investors. The implementing regulations are at 42 CFR part 402, subpart
A, and part 403, subpart I. We have organized these reporting
requirements under the ``Open Payments'' program.
The Open Payments program creates transparency around the nature
and extent of relationships that exist between drug, device,
biologicals and medical supply manufacturers, and physicians and
teaching hospitals (covered recipients and physician owner or
investors). The implementing regulations, which describe procedures for
applicable manufacturers and applicable GPOs to submit electronic
reports detailing payments or other transfers of value and ownership or
investment interests provided to covered recipients and physician
owners or investors, are codified at Sec. 403.908.
Since the publication and implementation of the February 8, 2013
final rule, various stakeholders have provided feedback to CMS
regarding certain aspects of these reporting requirements.
Specifically, Sec. 403.904(g)(1) excludes the reporting of payments
associated with certain continuing education events, and Sec.
403.904(c)(8) requires reporting of the marketed name for drugs and
biologicals but makes reporting the marketed name of devices or medical
supplies optional. We proposed a change to Sec. 403.904(g) to correct
an unintended consequence of the current regulatory text. Additionally,
at Sec. 403.904(c)(8), we proposed to make the reporting requirements
consistent by requiring the reporting of the marketed name for drugs,
devices, biologicals, or medical supplies which are associated with a
payment or other transfer of value.
Additionally, at Sec. 403.902, we proposed to remove the
definition of a ``covered device'' because we believe it is duplicative
of the definition of ``covered drug, device, biological or medical
supply'' which is codified in the same section. We also proposed to
require the reporting of the following distinct forms of payment:
stock; stock option; or any other ownership interests specified in
Sec. 403.904(d)(3) to collect more specific data regarding the forms
of payment.
2. Continuing Education Exclusion (Sec. 403.904(g)(1))
In the February 8, 2013 final rule, many commenters recommended
that accredited or certified continuing education payments to speakers
should not be reported because there are safeguards already in place,
and they are not direct payments to a covered recipient. In the final
rule preamble, we noted that ``industry support for accredited or
certified continuing education is a unique relationship'' (78 FR 9492).
Section 403.904(g)(1) states that payments or other transfers of value
provided as compensation for speaking at a continuing education program
need not be reported if the following three conditions are met:
The event at which the covered recipient is speaking must
meet the accreditation or certification requirements and standards for
continuing education for one of the following organizations: the
Accreditation Council for Continuing Medical Education (ACCME); the
American Academy of Family Physicians (AAFP); the American Dental
Association's Continuing Education Recognition Program (ADA CERP); the
American Medical Association (AMA); or the American Osteopathic
Association (AOA).
The applicable manufacturer does not pay the covered
recipient speaker directly.
The applicable manufacturer does not select the covered
recipient speaker or provide the third party (such as a continuing
education vendor) with a distinct, identifiable set of individuals to
be considered as speakers for the continuing education program.
Since the implementation of Sec. 403.904(g)(1), other accrediting
organizations have requested that payments made to speakers at their
events also be exempted from reporting. These organizations have stated
that they follow the same accreditation standards as the organizations
specified in Sec. 403.904(g)(1)(i). Other stakeholders have
recommended that the exemption be removed in its entirety stating
[[Page 67759]]
removal of the exclusion will allow for consistent reporting for
compensation provided to physician speakers at all continuing education
events, as well as transparency regarding compensation paid to
physician speakers. Many stakeholders raised concerns that the
reporting requirements are inconsistent because certain continuing
education payments are reportable, while others are not. CMS' apparent
endorsement or support to organizations sponsoring continuing education
events was an unintended consequence of the final rule.
After consideration of these comments, we proposed to remove the
language in Sec. 403.904(g) in its entirety, in part because it is
redundant with the exclusion in Sec. 403.904(i)(1). That provision
excludes indirect payments or other transfers of value where the
applicable manufacturer is ``unaware'' of, that is, ``does not know,''
the identity of the covered recipient during the reporting year or by
the end of the second quarter of the following reporting year. When an
applicable manufacturer or applicable GPO provides funding to a
continuing education provider, but does not either select or pay the
covered recipient speaker directly, or provide the continuing education
provider with a distinct, identifiable set of covered recipients to be
considered as speakers for the continuing education program, CMS will
consider those payments to be excluded from reporting under Sec.
403.904(i)(1). This approach is consistent with our discussion in the
preamble to the final rule, in which we explained that if an applicable
manufacturer conveys ``full discretion'' to the continuing education
provider, those payments are outside the scope of the rule (78 FR
9492). In contrast, for example, when an applicable manufacturer
conditions its financial sponsorship of a continuing education event on
the participation of particular covered recipients, or pays a covered
recipient directly for speaking at such an event, those payments are
subject to disclosure.
We considered two alternative approaches to address this issue.
First, we explored expanding the list of organizations in Sec.
403.904(g)(1)(i) by name; however, we believe that this approach might
imply CMS's endorsement of the named continuing education providers
over others. Second, we considered expansion of the organizations in
Sec. 403.904(g)(1)(i) by articulating accreditation or certification
standards that would allow a CME program to qualify for the exclusion.
This approach is not easily implemented because it would require
evaluating both the language of the standards, as well as the
enforcement of the standards of any organization professing to meet the
criteria. We solicited comments on both alternatives presented,
including commenters' suggestions about what standards, if any, CMS
should incorporate.
The following is summary of the comments we received regarding both
alternatives presented, and what standards, if any, CMS should
incorporate.
Comment: We received numerous comments addressing our proposal to
remove the exclusion for compensation for speaking at a continuing
education program. Some comments were in support to remove the
exclusion stating it is an important step toward ensuring transparency.
Supporting comments also agreed removing the exclusion will level the
playing field with the medical education community. Numerous commenters
questioned our proposal to remove the exclusion for compensation for
speaking at a continuing education program. Commenters provided
background regarding accrediting continuing education organizations
stating that creating continuing education accreditation standards is a
function of professional self-regulation and additional government
regulation is not necessary.
Many commenters recommend modifying the indirect payment exclusion
currently at Sec. 403.904(i)(1) to specify a continuing education
indirect payment should be excluded if the manufacturer did not know
the identity of the covered recipient before providing the payment to a
third party, such as a continuing education organization. This differs
from the current indirect payment exclusion language which states the
payment is excluded if the manufacturer did not know the identity of
the covered recipient during the reporting year or by the end of the
second quarter of the following reporting year. Commenters stated it is
not practical for a manufacturer to not know the identity of a
physician speaker receiving compensation for speaking at a continuing
education event during the reporting year or by the end of the second
quarter of the following reporting year because manufacturers could
learn the identities of physician speakers through brochures, programs
and other publications. Therefore, commenters assert that the indirect
payment exclusion is not applicable to exclude compensation provided to
physicians at a continuing education event and recommend the indirect
payment exclusion is modified to accommodate indirect payments provided
to a physician covered recipient through a continuing medical education
organization.
Additionally, commenters suggested an alternative approach where
CMS would adopt established criteria, such as the Standards for
Commercial Support: Standards to Ensure Independence in CME Activities,
in order to have payments provided to physicians at continuing
education events excluded. Similar criteria suggested by commenters to
modify the exclusion were: does not pay covered speakers or attendees
directly, does not select covered recipient speakers or provide a third
party with a distinct, identifiable set of individuals to be considered
as speakers or attendees for the continuing education program, and does
not control the continuing education program content.
Response: We appreciate commenters support to remove the exclusion
for compensation for speaking at a continuing education program. We
appreciate the comments stating that continuing medical education
accrediting organizations is a function of professional self-
regulation. We believe creating consistent reporting requirements for
all continuing education events, by removing the language in Sec.
403.904(g) in its entirety, will provide enhanced regulatory clarity
for stakeholders. Manufacturers reporting compensation paid to
physician speakers may opt to distinguish if the payment was provided
at an accredited or certified continuing education program versus an
unaccredited or non-certified continuing education program by selecting
the appropriate nature of payment category at Sec. 403.904(e).
We understand commenters concern regarding learning the identity of
the physician during the reporting year or by the end of the second
quarter of the following reporting year. In the situation of an
applicable manufacturer providing an indirect payment through a
continuing education organization and learning the identity of the
physician covered recipient in the allotted timeframe (during the
reporting year or by the end of the second quarter of the following
reporting year) the indirect payment would not meet the criteria of the
indirect payment exclusion and would need to be reported. However,
payments or other transfers of value, including payments made to
physician covered recipients for purposes of attending or speaking at
continuing education events, which do not meet the definition of an
indirect payment, as
[[Page 67760]]
defined at Sec. 403.902, are not reportable. For example, if an
applicable manufacturer or applicable GPO provides funding to support a
continuing education event but does not require, instruct, direct, or
otherwise cause the continuing education event provider to provide the
payment or other transfer or value in whole or in part to a covered
recipient, the applicable manufacturer or applicable GPO is not
required to report the payment or other transfer of value. The payment
is not reportable regardless if the applicable manufacturer or
applicable GPO learns the identity of the covered recipient during the
reporting year or by the end of the second quarter of the following
reporting year because the payment or other transfer of value did not
meet the definition of an indirect payment. This approach is also
consistent with our statement at (78 FR 9490), where we explained that
``if an applicable manufacturer provided an unrestricted donation to a
physician professional organization to use at the organization's
discretion, and the organization chose to use the donation to make
grants to physicians, those grants would not constitute `indirect
payments' because the applicable manufacturer did not require,
instruct, or direct the organization to use the donation for grants to
physicians.'' Therefore, because such payments are not indirect
payments, we do not need to create an additional exclusion specific to
continuing education indirect payments by modifying the indirect
payment exclusion at Sec. 403.904(i)(1).
Comment: Many commenters interpreted the removal of physician
speaker compensation at continuing education events would also remove
the reporting exclusion for attendees at accredited or certified
continuing education events whose fees have been subsidized through the
continuing medical education organization by an applicable
manufacturers.
Response: We did not intend to remove the exclusion regarding
subsidized fees provided to physician attendees by manufacturers at
continuing education events. However, we intend for physician speaker
compensation and physician attendees fees which have been subsidized
through the continuing medical education organization by an applicable
manufacturer to be reported unless the payment meets the indirect
payment exclusion at Sec. 403.904(i)(1). This allows for consistent
reporting for physician attendees and speakers at continuing education
events. We will provide sub-regulatory guidance specifying tuition fees
provided to physician attendees that have been generally subsidized at
continuing education events by manufacturers are not expected to be
reported. However, if a manufacturer does instruct, direct, or
otherwise cause the subsidized tuition fee for a continuing education
event to go to a specific physician attendee, the payment will not be
excluded, since the indirect payment exclusion only applies if the
manufacturer did not know the identity of the physician attendee.
Comment: Many commenters interpreted the proposed removal ofSec.
403.904(g) to expand the exclusion to account for continuing education
programs accredited or certified for nurses, optometrists, pharmacists,
and others.
Response: We appreciate the comments, but the removal ofSec.
403.904(g) was not intended to expand the exclusion. The intent is to
allow for consistent reporting for compensation provided to physician
speakers at all continuing education events, as well as transparency
regarding compensation paid to physician speakers.
Comment: A few commenters requested CMS provide clear and realistic
timeframes regarding payments related to continuing education events to
allow manufacturers to provide sponsor notice as it considers proposals
to eliminate the current CME exclusion.
Response: We agree with commenters that manufacturers may need
additional time to comply with reporting requirements; therefore, we
are finalizing data collection requirements that would begin January 1,
2016 according to this final rule for applicable manufacturers.
3. Reporting of Marketed Name (Sec. 403.904(c)(8))
Section 1128G(a)(1)(A)(vii) of the Act requires applicable
manufacturers to report the name of the covered drug, device,
biological or medical supply associated with that payment, if the
payment is related to ``marketing, education, or research'' of a
particular covered drug, device, biological, or medical supply. Section
403.904(c)(8)(i) requires applicable manufacturers to report the
marketed name for each drug or biological related to a payment or other
transfer of value. At Sec. 403.904(c)(8)(ii), we require an applicable
manufacturer of devices or medical supplies to report one of the
following: the marketed name; product category; or therapeutic area. In
the February 8, 2013, final rule, we provided applicable manufactures
with flexibility when it was determined that the marketed name for all
devices and medical supplies may not be useful for the general
audience. We did not define product categories or therapeutic areas in
Sec. 403.904(c). However, since implementation of the February 8, 2013
final rule and the development of the Open Payments system, we have
determined that aligning the reporting requirements for marketed name
across drugs, biologics, devices and medical supplies will make the
data fields consistent within the system, and also enhance consumer's
use of the data.
Accordingly, we proposed to revise Sec. 403.904(c)(8) to require
applicable manufacturers to report the marketed name for all covered
drugs, devices, biologicals or medical supplies. We believe this would
facilitate consistent reporting for the consumers and researchers using
the data displayed publicly on the Open Payments. Manufacturers would
still have the option to report product category or therapeutic area,
in addition to reporting the market name, for devices and medical
supplies.
Comment: We received a few comments regarding revising reporting
requirements at Sec. 403.904(c)(8). These comments mainly stated that
the marketed name for a device or medical supply is not useful for the
public because the public is not familiar with device or medical supply
marketed names. We also received a few comments that supported
requiring the reporting of marketed name for devices and medical
supplies. Supporting commenters believe that reporting marketed name
for all products will allow the public (including researchers and
consumers) to search the data via the Open Payments public Web site for
a specific device or medical supply. Commenters also stated that
reporting marketed name for non-covered products is not required by the
statute and therefore manufacturers should not be required to report
marketed names for non-covered products. Additionally, some comments
indicated reporting marketed name for devices and medical supplies for
research payments is not practical because there is not a marketed name
for every device or medical supply associated with research payments;
rather there may only be a connection to an associated research study.
A few commenters addressed that manufacturers will have an increased
burden to modify reporting systems to accommodate reporting marketed
name for devices and medical supplies.
Response: We appreciate the comments supporting our proposed
revisions requiring reporting marketed name for devices and medical
supplies.
[[Page 67761]]
We have finalized a modified approach to accommodate concerns regarding
reporting related covered drug, device, biological or medical supply
information. We agree manufacturers should not be required to report
marketed names for non-covered products; therefore, we are finalizing
the proposal that reporting marketed names for non-covered drugs,
devices, biologicals, or medical supplies will continue to be optional.
We also agree a payment or other transfer of value associated with a
research payment regarding a device or medical supply may not have a
marketed name. Therefore, we are finalizing the proposal that
manufacturers will continue to have an option to report either a device
or medical supply marketed name, therapeutic area or product category
when reporting research payments.
After consideration of comments received, we agree that displaying
therapeutic areas or product categories are useful for the public
reviewing data on the Open Payments public Web site because the public
is not familiar with marketed names for devices and medical supplies.
We agree therapeutic areas and products categories are more
recognizable by the public. Yet, reporting marketed names for all
covered products is necessary to achieve consistent reporting and to
have the ability to aggregate all payments or other transfers of value
associated with a specific device or medical supply. Therefore to
achieve consistent reporting by manufacturers, we will require
manufacturers to report marketed name and therapeutic area or product
category for all covered drugs, devices, biologicals or medical
supplies. We also agree with commenters that complying with this
reporting requirement will require a change in manufacturers' reporting
systems; therefore, data collection for this reporting requirement
would begin January 1, 2016.
4. Reporting of Stock, Stock Option, or Any Other Ownership Interest
Section 403.904(d)(3) requires the reporting of stock, stock
option, or any other ownership interest. We proposed to require
applicable manufacturers to report such payments as distinct
categories. This will enable us to collect more specific data regarding
the forms of payment made by applicable manufacturers. After issuing
the February 8, 2013 final rule and the development of the Open
Payments system, we determined that this specificity will increase the
ease of data aggregation within the system, and also enhance consumer's
use of the data. We solicited comments on the extent to which users of
this data set find this disaggregation to be useful, and whether this
change presents operational or other issues on the part of applicable
manufacturers.
The following is summary of the comments we received regarding the
extent to which users of this data set find this disaggregation to be
useful, requiring reporting of marketed name for covered devices and
medical supplies, and whether this change presents operational or other
issues on the part of applicable manufacturers.
Comment: Commenters agreed that requiring reporting of stock, stock
option or any other ownership interest in distinct categories is
useful.
Response: We agree the disaggregation of reporting stock, stock
option or any other ownership interest in distinct categories.
Therefore, we have finalized this provision as proposed, which requires
reporting stock, stock option, or any other ownership interest form of
payment or other transfer of value in distinct categories.
J. Physician Compare Web Site
1. Background and Statutory Authority
Section 10331(a)(1) of the Affordable Care Act, requires that, by
no later than January 1, 2011, we develop a Physician Compare Internet
Web site with information on physicians enrolled in the Medicare
program under section 1866(j) of the Act, as well as information on
other eligible professionals (EPs) who participate in the Physician
Quality Reporting System (PQRS) under section 1848 of the Act.
CMS launched the first phase of Physician Compare on December 30,
2010 (http://www.medicare.gov/physiciancompare). In the initial phase,
we posted the names of EPs that satisfactorily submitted quality data
for the 2009 PQRS, as required by section 1848(m)(5)(G) of the Act.
Section 10331(a)(2) of the Affordable Care Act also requires that,
no later than January 1, 2013, and for reporting periods that began no
earlier than January 1, 2012, we implement a plan for making publicly
available through Physician Compare information on physician
performance that provides comparable information on quality and patient
experience measures. We met this requirement in advance of January 1,
2013, as outlined below, and plan to continue addressing elements of
the plan through rulemaking.
To the extent that scientifically sound measures are developed and
are available, we are required to include, to the extent practicable,
the following types of measures for public reporting:
Measures collected under the Physician Quality Reporting
System (PQRS).
An assessment of patient health outcomes and functional
status of patients.
An assessment of the continuity and coordination of care
and care transitions, including episodes of care and risk-adjusted
resource use.
An assessment of efficiency.
An assessment of patient experience and patient,
caregiver, and family engagement.
An assessment of the safety, effectiveness, and timeliness
of care.
Other information as determined appropriate by the
Secretary.
As required under section 10331(b) of the Affordable Care Act, in
developing and implementing the plan, we must include, to the extent
practicable, the following:
Processes to ensure that data made public are
statistically valid, reliable, and accurate, including risk adjustment
mechanisms used by the Secretary.
Processes for physicians and eligible professionals whose
information is being publicly reported to have a reasonable
opportunity, as determined by the Secretary, to review their results
before posting to Physician Compare. We have established a 30-day
preview period for all measurement performance data that will allow
physicians and other EPs to view their data as it will appear on the
Web site in advance of publication on Physician Compare (77 FR 69166
and 78 FR 74450). Details of the preview process will be communicated
directly to those with measures to preview and will also be published
on the Physician Compare Initiative page (http://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/physician-compare-initiative/) in advance of the preview period.
Processes to ensure the data published on Physician
Compare provides a robust and accurate portrayal of a physician's
performance.
Data that reflects the care provided to all patients seen
by physicians, under both the Medicare program and, to the extent
applicable, other payers, to the extent such information would provide
a more accurate portrayal of physician performance.
Processes to ensure appropriate attribution of care when
multiple physicians and other providers are involved in the care of the
patient.
Processes to ensure timely statistical performance
feedback is
[[Page 67762]]
provided to physicians concerning the data published on Physician
Compare.
Implementation of computer and data infrastructure and
systems used to support valid, reliable and accurate reporting
activities.
Section 10331(d) of the Affordable Care Act requires us to consider
input from multi-stakeholder groups, consistent with sections
1890(b)(7) and 1890A of the Act, when selecting quality measures for
Physician Compare. We also continue to get general input from
stakeholders on Physician Compare through a variety of means, including
rulemaking and different forms of stakeholder outreach (for example,
Town Hall meetings, Open Door Forums, webinars, education and outreach,
Technical Expert Panels, etc.). In developing the plan for making
information on physician performance publicly available through
Physician Compare, section 10331(e) of the Affordable Care Act requires
the Secretary, as the Secretary determines appropriate, to consider the
plan to transition to value-based purchasing for physicians and other
practitioners that was developed under section 131(d) of the MIPPA.
Under section 10331(f) of the Affordable Care Act, we are required
to submit a report to the Congress by January 1, 2015, on Physician
Compare development, and include information on the efforts and plans
to collect and publish data on physician quality and efficiency and on
patient experience of care in support of value-based purchasing and
consumer choice. Section 10331(g) of the Affordable Care Act provides
that any time before that date, we may continue to expand the
information made available on Physician Compare.
We believe section 10331 of the Affordable Care Act supports our
overarching goals of providing consumers with quality of care
information that will help them make informed decisions about their
health care, while encouraging clinicians to improve the quality of
care they provide to their patients. In accordance with section 10331
of the Affordable Care Act, we plan to publicly report physician
performance information on Physician Compare.
2. Public Reporting of Performance and Other Data
Since the initial launch of the Web site, we have continued to
build on and improve Physician Compare. On June 27, 2013, we launched a
full redesign of Physician Compare bringing significant improvements
including a complete overhaul of the underlying database and a new
Intelligent Search feature, addressing two of our stakeholders' primary
critiques of the site--the accuracy and currency of the database and
the limitations of the search function--and considerably improving Web
site functionality and usability. Provider Enrollment, Chain, and
Ownership System (PECOS), as the sole source of verified Medicare
professional information, is the primary source of administrative
information on Physician Compare. With the redesign, however, we
incorporated the use of Medicare Fee-For-Service claims information to
verify the information in PECOS to help ensure only the most current
and accurate information is included on the site. For example, claims
information is used to determine which of the active and approved
practice locations in PECOS are where the professional is currently
providing services. Claims information helps confirm that only the most
current group practice affiliations are included on the site. Our use
of claims also helps ensure that we are posting on Physician Compare
the most current and accurate information available about the
professionals for Medicare consumers.
We received several comments about the enhancements made to the
Physician Compare Web site and the data currently on the Web site.
Comment: Several commenters noted the improvements made to the
Physician Compare Web site, including the additional labeling,
improvements to the ``Is this you?'' link, the reordering of the search
results, the Intelligent Search functionality, the use of claims data
to verify professionals' demographic information, denoting board
certified physicians with contextual text, and explanations and
disclaimers about each of the federal quality reporting programs
included on the Web site. Commenters also noted an appreciation for the
transparency and easy-to-use, comprehensive information available on
the site to aid consumers in making informed health care decisions.
Some commenters provided suggestions for future Physician Compare
enhancements. A few commenters suggested continued improvements to the
Intelligent Search functionality to better find health care
professionals other than physicians and additional specialty labels for
Advanced Practice Registered Nurses (APRNs) and allied health
professionals.
Response: We appreciate the commenters' feedback and the continued
support for the Physician Compare Web site. We are committed to
continuing to improve the site and its functionality to ensure it is a
useful resource for Medicare consumers, including information that can
help these consumers make informed health care decisions. We also
appreciate the recommendations regarding other health care
professionals, and we will evaluate these recommendations for potential
future inclusion. Also, we are continually working to improve and
enhance the Intelligent Search functionality.
Comment: Some commenters expressed concerns about the accuracy of
data such as demographic information, specialty classification, and
hospital affiliation. Several commenters urged CMS to address these
concerns prior to posting additional quality measure performance
information on the Web site. Other commenters requested we implement a
streamlined process by which professionals can confirm or correct their
information in a timely manner. One commenter urged CMS to ensure that
updates made in PECOS are reflected on Physician Compare within 30
days, while another commenter cautioned against using PECOS for
updating information. Several commenters suggested continuing to work
with stakeholders, particularly health care professionals, and/or
providing educational material regarding how to keep data current to
ensure the accuracy of the Web site.
Response: We appreciate the commenters' feedback regarding concerns
over the accuracy of the information currently available on Physician
Compare. We are committed to including accurate and up-to-date
information on Physician Compare and continue to work to make
improvements to the information presented.
The underlying database on Physician Compare is generated from
PECOS, as well as Fee-For-Service (FFS) claims, and it is therefore
critical that physicians, other health care professionals, and group
practices ensure that their information is up-to-date and as complete
as possible in the national PECOS database. Currently, the most
immediate way to address inaccurate PECOS data on Physician Compare is
by updating information via Internet-based PECOS at https://pecos.cms.hhs.gov/pecos/login.do. Please note that the specialties as
reported on Physician Compare are those specialties reported to
Medicare when a physician or other health care professional enrolls in
Medicare and are limited to the specialties noted on the 855i
Enrollment Form. All addresses listed on Physician Compare must be
entered in and verified in PECOS.
[[Page 67763]]
There is a lag between when an edit is made in PECOS and when that
edit is processed by the Medicare Administrative Contractor (MAC) and
available in the PECOS data pulled for Physician Compare. This time is
necessary for data verification but unfortunately results in a delay
updating information. We are continually working to find ways to
minimize this delay.
To update information not found in PECOS, such as hospital
affiliation and foreign language, professionals and group practices
should contact the Physician Compare support team directly at
[email protected]. Information regarding how to keep your
information current can also be found on the Physician Compare
Initiative page on CMS.gov (http://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/physician-compare-initiative/).
Although we appreciate the concerns raised around the PECOS data
included on Physician Compare, it is necessary to continue the use of
the PECOS data as it is the sole, verified source of Medicare
information. However, we are aware of its limitations. For these
reasons, we have instituted the use of claims information and are
continuing to work to find ways to further improve the data. The data
are significantly better today than they were prior to the 2013
redesign and continues to improve. We strongly encourage all
professionals and group practices listed on the site to regularly check
their data and to contact the support team with any questions or
concerns.
Currently, Web site users can view information about approved
Medicare professionals such as name, primary and secondary specialties,
practice locations, group affiliations, hospital affiliations that link
to the hospital's profile on Hospital Compare as available, Medicare
Assignment status, education, languages spoken, and American Board of
Medical Specialties (ABMS) board certification information. In
addition, for group practices, users can also view group practice
names, specialties, practice locations, Medicare assignment status, and
affiliated professionals.
We post on the Web site the names of individual EPs who
satisfactorily report under PQRS, as well as those EPs who are
successful electronic prescribers under the Medicare Electronic
Prescribing (eRx) Incentive Program. Physician Compare contains a link
to a downloadable database of all information on Physician Compare
(https://data.medicare.gov/data/physician-compare), including
information on this quality program participation. In addition, there
is a section on each Medicare professional's profile page indicating
with a green check mark the quality programs under which the EP
satisfactorily or successfully reported. We proposed (79 FR 40386) to
continue to include this information annually in the year following the
year it is reported (for example, 2015 PQRS reporting will be included
on the Web site in 2016). We did not receive any comments on this
proposal. We are finalizing this proposal at this time, and therefore,
will include satisfactory 2015 PQRS reporters on the Web site in 2016.
The eRx Incentive Program ends in 2014 so those data will not be
available in 2015 or beyond.
With the Physician Compare redesign, we added a quality programs
section to each group practice profile page in order to indicate which
group practices are satisfactorily reporting in the Group Practice
Reporting Option (GPRO) under PQRS or are successful electronic
prescribers under the eRx Incentive Program. We have also included a
notation and check mark for individuals that successfully participate
in the Medicare EHR Incentive Program, as authorized by section
1848(o)(3)(D) of the Act. We proposed (79 FR 40386) to continue to
include this information annually in the year following the year it is
reported (for example, 2015 data will be included on the Web site in
2016).
We did not receive any comments regarding our proposal regarding
this PQRS GPRO. We are finalizing the proposal to include a notation
for satisfactory PQRS GPRO reporters. As noted above, the eRx Incentive
Program is ending in 2014, and therefore, there will not be data for
this program in 2015 or beyond. We did receive comments regarding
including a notation for individuals that successfully participate in
the Medicare EHR Incentive Program.
Comment: Two commenters urged CMS to reconsider its decision to
publicly report participation in the Medicare EHR Incentive Program due
to ongoing issues related to the program--including unresolved
challenges related to vendor certification delays, concerns about the
relevancy to consumers, and limited ability to implement core measures.
One commenter suggested including a disclaimer next to the indicator
explaining these barriers and clarifying that successful participation
in the EHR Incentive Program is only one of various ways to demonstrate
an investment in higher quality care.
Response: We appreciate the commenters' feedback, and we will take
the suggestions provided regarding a disclaimer into consideration for
possible future enhancements. We also appreciate the concerns raised
about the program, specifically around vendor certification and core
measures. However, despite those potential limitations, a number of
professionals and groups are successfully taking part at this time and
we believe it is important to continue to recognize them. Also,
consumers find this information interesting and helpful. This is only
one of multiple quality programs included on Physician Compare that we
find important to highlight. As a result, we are going to finalize our
proposal to continue including an indicator for participation in the
EHR Incentive Program on the Web site.
We previously finalized a decision to publicly report the names of
those EPs who report the 2014 PQRS Cardiovascular Prevention measures
group in support of Million Hearts on Physician Compare in 2015, by
including a check mark in the quality programs section of the profile
page (78 FR 74450). We proposed (79 FR 40386) to also continue to
include this information annually in the year following the year it is
reported (for example, 2015 data will be included on Physician Compare
in 2016).
Comment: Some commenters supported our proposal to publicly report
and include an indicator for EPs who report the 2015 PQRS
Cardiovascular Prevention measures group in support of Million Hearts.
Commenters noted that Million Hearts is an important initiative for
supporting cardiovascular health.
Response: We appreciate the commenters' support. We agree that
Million Hearts is an important initiative that is improving outcomes
for cardiovascular health. However, we are finalizing the removal of
the Cardiovascular Prevention measure group from the PQRS program given
that the two cholesterol control measures included in the measure group
are no longer clinically relevant, and therefore, the measure group no
longer meets the necessary threshold for PQRS of six measures and will
no longer be available for reporting under the program. With the
removal of the 2 cholesterol control measures, the remaining measures
from the original Cardiovascular Prevention measure group are:
Ischemic Vascular Disease (IVD): Use of Aspirin or Another
Antithrombotic.
Preventive Care and Screening: Tobacco Use.
[[Page 67764]]
Controlling High Blood Pressure.
Preventive Care and Screening: Screening for High Blood
Pressure and Follow-Up Documented.
All of these measures are available as individual measures under
PQRS. Given that the Cardiovascular Prevention measure group is being
eliminated from the PQRS, but that the remaining measures identified
above will be available for individual reporting, we are modifying our
final policy with regard to our proposal to support Million Hearts on
Physician Compare. Specifically, we are finalizing that any EP that
satisfactorily reports all four of the individual measures noted above
will receive a green check mark indicating support for Million Hearts.
A key strategy of the Million Hearts initiative is to reduce the number
of heart attacks and strokes, and the program has found that reporting
these quality measures is a first step toward performance improvement.
We are committed to supporting this initiative, and even though the
measure group is no longer available under PQRS, we think it is
important to continue recognizing those individual EPs who are
reporting these quality measures as individual measures. Even though
the individual measures require that a potentially higher number of
patients are reported on--50 percent of patients that meet the sample
requirements versus just 20 patients for the measure group--we believe
this does not increase burden on reporters because as currently
available claims data show, significantly more EPs are already
reporting these measures as individual PQRS measures versus as part of
the Cardiovascular Prevention measures group. Ensuring these
professionals are recognized for reporting these measures is important
in ensuring we are continuing support for this important program
despite the measure group no longer being available for reporting.
Finally, we will also indicate with a green check mark those
individuals who have earned the 2014 PQRS Maintenance of Certification
Incentive (Additional Incentive) on the Web site in 2015 (78 FR 74450).
Comment: Several commenters supported publicly reporting earners of
the PQRS Maintenance of Certification (MOC) program Additional
Incentive, as well as ABMS Board Certification data, while other
commenters are concerned that ABMS data are not complete or only
include some specialists. Multiple commenters suggested including other
Boards' certifications and MOC programs, contextual certification
process information, and the certifying Board's identification.
Response: We appreciate the commenters' feedback and support for
including ABMS and PQRS MOC information on Physician Compare. We also
understand the concerns that not all specialties are presented by the
ABMS data and will review the recommendations made to include
additional certification and MOC program information on the Web site
for possible inclusion in the future.
We continue to implement our plan for a phased approach to public
reporting performance information on Physician Compare. The first phase
of this plan was finalized with the CY 2012 PFS final rule with comment
period (76 FR 73419-73420), where we established that PQRS GPRO
measures collected through the GPRO Web Interface for 2012 would be
publicly reported on Physician Compare. The plan was expanded with the
CY 2013 PFS final rule with comment period (77 FR 69166), where we
established that the specific GPRO Web Interface measures that would be
posted on Physician Compare would include the PQRS GPRO measures for
Diabetes Mellitus (DM) and Coronary Artery Disease (CAD), and we noted
that we would report composite measures for these measure groups in
2014, if technically feasible.\6\ The 2012 PQRS GPRO measures were
publicly reported on Physician Compare in February 2014. Data reported
in 2013 on the GPRO DM and GPRO CAD measures and composites collected
via the GPRO Web Interface that meet the minimum sample size of 20
patients and prove to be statistically valid and reliable will be
publicly reported on Physician Compare in December CY 2014, if
technically feasible. If the minimum threshold is not met for a
particular measure, or the measure is otherwise deemed not to be
suitable for public reporting, the group's performance rate on that
measure will not be publicly reported. We will only publish on
Physician Compare those measures that are statistically valid and
reliable, and therefore, most likely to help consumers make informed
decisions about the Medicare professionals they choose to meet their
health care needs.
---------------------------------------------------------------------------
\6\ By ``technically feasible'' we mean that there are no
operational constraints inhibiting us from moving forward on a given
public reporting objective. Operational constraints include delays
and/or issues related to data collection which render a set of
quality data unavailable in the timeframe necessary for public
reporting.
---------------------------------------------------------------------------
Measures must be based on reliable and valid data elements to be
useful to consumers and thus included on Physician Compare. A reliable
data element is consistently measuring the same thing regardless of
when or where it is collected, while a valid data element is measuring
what it is meant to measure. To address the reliability of performance
scores, we will measure the extent to which differences in each quality
measure are due to actual differences in clinician performance versus
variation that arises from measurement error. Statistically,
reliability depends on performance variation for a measure across
clinicians (``signal''), the random variation in performance for a
measure within a clinician's panel of attributed beneficiaries
(``noise''), and the number of beneficiaries attributed to the
clinician. High reliability for a measure suggests that comparisons of
relative performance across clinicians are likely to be stable over
different performance periods and that the performance of one clinician
on the quality measure can confidently be distinguished from another.
Potential reliability values range from zero to one, where one (highest
possible reliability) means that all variation in the measure's rates
is the result of variation in differences in performance, while zero
(lowest possible reliability) means that all variation is a result of
measurement error. Reliability testing methods included in the CMS
Measures Management System Blueprint (https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/MMS/MeasuresManagementSystemBlueprint.html) include test-retest reliability
and analysis of variance (ANOVA). Reliability tests endorsed by the NQF
include the beta-binomial model test.
The validity of a measure refers to the ability to record or
quantify what it claims to measure. To analyze validity, we can
investigate the extent to which each quality measure is correlated with
related, previously validated, measures. We can assess both concurrent
and predictive validity. Predictive validity is most appropriate for
process measures or intermediate outcome measures, in which a cause-
and-effect relationship is hypothesized between the measure in question
and a validated outcome measure. Therefore, the measure in question is
computed first, and the validated measure is computed using data from a
later period. To examine concurrent validity, the measure in question
and a previously validated measure are computed using contemporaneous
data. In this context, the previously validated measure should measure
a health outcome related to the outcome of interest.
Comment: Many commenters supported only publishing on Physician
[[Page 67765]]
Compare those measures that are statistically valid and reliable.
Several commenters urged CMS to carefully assess if all GPRO measure
data is sufficiently reliable and valid for public reporting before
posting the data. One commenter recommended removing any measures
deemed unreliable or inaccurate. One commenter recommended a one-year
delay in public reporting of all new measures to enable professionals
to accurately report the measures and to account for measure testing
and validity.
One commenter requested CMS publish the results of validity and
reliability studies, as well as the methodology for choosing measures
prior to posting on Physician Compare. Another commenter is concerned
that measures related to patient behavior, preferences, or abilities do
not provide a statistically valid portrayal of a health care
professional's performance and should not be published unless the data
is appropriately risk adjusted. Several other commenters also strongly
urged CMS to move forward with expanding its risk adjustment
methodology.
Response: We appreciate the commenters' feedback, and understand
the concerns raised. As required under section 10331(b) of the
Affordable Care Act, in developing and implementing the plan to include
performance data on Physician Compare, we must include, to the extent
practicable, processes to ensure that the data posted on the Web site
are statistically valid, reliable, and accurate, including risk
adjustment mechanisms used by the Secretary. We understand that this
information is complex and are committed to providing data on Physician
Compare that are useful to beneficiaries in assisting them in making
informed health care decisions, while being accurate, valid, reliable,
and complete. We will closely evaluate all quality measures under
consideration for public reporting on the Web site to ensure they are
meeting these standards. We will also only post data that meet the
established standards of reliability and validity regardless of
threshold, and regardless of measure type. Should we find a measure
meeting the minimum threshold to be invalid or unreliable for any
reason, the measure will not be reported. We are also making changes in
light of the concerns about first year measures. We will not publicly
post measures that are in their first year given the concerns raised
about their validity, reliability, accuracy, and comparability. After a
measure's first year in the program, CMS will evaluate the measure to
see if and when the measure is suitable for pubic reporting. Also, we
will continue to analyze the measure data to ensure that risk
adjustment concerns are taken into consideration. All data are analyzed
and reviewed by our Technical Expert Panel (TEP). A summary of the TEP
recommendations is made public on the Physician Compare Initiative page
(http://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/physician-compare-initiative/Informational-Materials.html)
when available.
In the November 2011 Medicare Shared Savings Program final rule (76
FR 67948), we noted that because Accountable Care Organization (ACO)
providers/suppliers that are EPs are considered to be a group practice
for purposes of qualifying for a PQRS incentive under the Shared
Savings Program, we would publicly report ACO performance on quality
measures on Physician Compare in the same way as we report performance
on quality measures for PQRS GPRO group practices. Public reporting of
performance on these measures is presented at the ACO level only. The
first sub-set of ACO measures was also published on the Web site in
February 2014. ACO measures can be viewed by following the link for
Accountable Care Organization (ACO) Quality Data on the homepage of the
Physician Compare Web site (http://medicare.gov/physiciancompare/aco/search.html).
As part of our public reporting plan for Physician Compare, in the
CY 2013 PFS final rule with comment period (77 FR 69166 and 69167), we
also finalized the decision to publicly report Clinician and Group
Consumer Assessment of Healthcare Providers and Systems (CG-CAHPS) data
for group practices of 100 or more eligible professionals reporting
data in 2013 under the GPRO and for ACOs participating in the Shared
Savings Program, if technically feasible. We anticipate posting these
data on Physician Compare in late 2014, if available.
We continued to expand our plan for public reporting data on
Physician Compare in the CY 2014 PFS final rule with comment period (78
FR 74449). In that final rule we finalized a decision that all measures
collected through the GPRO Web Interface for groups of two or more EPs
participating in 2014 under the PQRS GPRO and for ACOs participating in
the Medicare Shared Savings Program would be available for public
reporting in CY 2015. As with all measures we finalized with regard to
Physician Compare, these data would include measure performance rates
for measures reported that meet the minimum sample size of 20 patients
and prove to be statistically valid and reliable. We also finalized a
30-day preview period prior to publication of quality data on Physician
Compare. This will allow group practices to view their data as it will
appear on Physician Compare before it is publicly reported. We decided
that we will detail the process for the 30-day preview and provide a
detailed timeline and instructions for preview in advance of the start
of the preview period. ACOs will be able to view their quality data
that will be publicly reported on Physician Compare through the ACO
Quality Reports, which will be made available to ACOs for review at
least 30 days prior to the start of public reporting on Physician
Compare.
We also finalized a decision to publicly report in CY 2015 on
Physician Compare performance on certain measures that group practices
report via registries and EHRs in 2014 for the PQRS GPRO (78 FR 74451).
Specifically, we finalized making available for public reporting
performance on 16 registry measures and 13 EHR measures (78 FR 74451).
These measures are consistent with the measures available for public
reporting via the Web Interface. We will indicate the mechanism by
which these data were collected and only those data deemed
statistically comparable, valid, and reliable would be published on the
site.
We also finalized publicly reporting patient experience survey-
based measures from the CG-CAHPS measures for groups of 100 or more
eligible professionals who participate in PQRS GPRO, regardless of GPRO
submission method, and for Shared Savings Program ACOs reporting
through the GPRO Web Interface or other CMS-approved tool or interface
(78 FR 74452). For 2014 data, we finalized publicly reporting data for
the 12 summary survey measures also finalized for groups of 25 to 99
for PQRS reporting requirements (78 FR 74452). These summary survey
measures would be available for public reporting group practices of 100
or more EPs participating in PQRS GPRO, as well as group practices of
25 to 99 EPs when collected via any certified CAHPS vendor regardless
of PQRS participation, as technically feasible. For ACOs participating
in the Shared Savings Program, the patient experience measures that are
included in the Patient/Caregiver Experience domain of the Quality
Performance Standard under the Shared Savings Program (78 FR 74452)
will be available for public reporting in 2015.
For 2014, we also finalized publicly reporting 2014 PQRS measure
data
[[Page 67766]]
reported by individual EPs in late CY 2015 for individual PQRS quality
measures specifically identified in the final rule with comment period,
if technically feasible. Specifically, we finalized to make available
for public reporting 20 individual measures collected through a
registry, EHR, or claims (78 FR 74453-74454). These are measures that
are in line with those measures reported by groups via the GPRO Web
Interface.
Finally, in support of the HHS-wide Million Hearts Initiative, we
finalized a decision to publicly report, no earlier than CY 2015,
performance rates on measures in the PQRS Cardiovascular Prevention
measures group at the individual EP level for data collected in 2014
for the PQRS (78 FR 74454). See Table 48 for a summary of our final
policies for public reporting data on Physician Compare.
[[Page 67767]]
[GRAPHIC] [TIFF OMITTED] TR13NO14.064
[[Page 67768]]
3. Final Policies for Public Data Disclosure on Physician Compare in
2015 and 2016
We are continuing the expansion of public reporting on Physician
Compare by making an even broader set of quality measures available for
publication on the Web site. We started the phased approach with a
small number of possible PQRS GPRO Web Interface measures for 2012 and
have been steadily building on this to provide Medicare consumers with
more information to help them make informed health care decisions. As a
result, we proposed (79 FR 40388) to increase the measures available
for public reporting in the CY 2015 proposed PFS rule.
Comment: Although multiple commenters supported continuing the
phased approach to public reporting of quality data, a number of
commenters are concerned with the aggressive timeline for publicly
reporting performance data. Several commenters supported a more gradual
approach to public reporting to evaluate the public response to data
prior to widespread implementation, ensure accuracy, and present data
in a format that is easy to understand, meaningful, and actionable for
both patients and health care professionals. A few commenters were
unsure if CMS conducted analysis of consumer use of the site and urged
CMS to do so. Other commenters opposed the extensive expansion until
existing Web site problems are addressed.
Response: We appreciate the commenters' feedback, and we appreciate
the concerns raised. However, we believe that public reporting of
quality data has been a measured, phased approach which started with
the publication of just five 2012 PQRS GPRO measures collected via the
Web Interface for 66 group practices and 141 ACOs (76 FR 73417) and
continues with a similarly limited set of 2013 PQRS GPRO Web Interface
measures (77 FR 69166). We started to build on this plan with the 2014
Physician Fee Schedule (PFS) final rule (78 FR 74446). This rule made
additional PQRS GPRO measures available for public reporting, including
a subset of measures reported via Registry and EHR, as well as a sub-
set of 20 individual EP PQRS measures. Therefore, the proposals put
forth this year are just the next step in the process to realize goals
for authorization of Physician Compare. We are confident that taking
this phased approach has afforded us the opportunity to prepare for
this significant expansion.
Throughout this process, we have been engaging with consumers and
stakeholders and regularly testing the site and the information to be
included to ensure it is accurately presented and understood. We are
also continually working to improve the Web site and the administrative
and demographic information included. We continue to encourage
physicians, other health care professionals, and group practices to
ensure their information is updated in PECOS so that we can ensure the
most accurate information is available on Physician Compare. We also
encourage individuals and groups to reach out to the Physician Compare
support team at [email protected] for any questions or
concerns regarding the information included on the Web site.
We proposed (79 FR 40388) to expand public reporting of group-level
measures by making all 2015 PQRS GPRO measure sets across group
reporting mechanisms--GPRO Web Interface, registry, and EHR--available
for public reporting on Physician Compare in CY 2016 for groups of 2 or
more EPs, as appropriate by reporting mechanism.\7\ Similarly, we also
proposed that all measures reported by Shared Savings Program ACOs
would be available for public reporting on Physician Compare. As with
all quality measures proposed for inclusion on Physician Compare, we
noted that only measures that prove to be valid, reliable, and accurate
upon analysis and review at the conclusion of data collection would be
included on the Web site.
---------------------------------------------------------------------------
\7\ Tables Q1-Q27 detail proposed changes to available PQRS
measures. Additional information on PQRS measures can be found on
the CMS.gov PQRS Web site at http://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/PQRS/index.html.
---------------------------------------------------------------------------
Comment: Commenters were both positive and negative in regard to
our proposal to expand the group-level measures available for public
reporting to all measures reported under 2015 PQRS GPRO. Commenters in
support of the proposal noted group-level measures are a robust
indication of care team quality and helpful to consumers. Some
commenters opposed the expansion and cited concerns with the accuracy
of current data as well as measure fidelity. One commenter encouraged
CMS to ensure that GPRO quality data is accurately labeled and
accessible through the group entry only to ensure it is clear what the
quality measure represents. One commenter asked for clarification on
the availability of the PQRS GPRO Web Interface reporting option for
groups of two or more EPs.
Response: We appreciate the commenters' feedback on our proposal to
report all 2015 PQRS measures reported via the Web Interface, EHR, and
Registry for group practices of 2 or more EPs participating in the PQRS
GPRO. As noted, Physician Compare will only publicly report those
measures evaluated to be comparable, reliable, and valid. Also, we will
continue to work to ensure that measures are labeled accurately and
accompanied by explanations that are both true to the measure
specifications and accurately understood by health care consumers,
while adhering to HHS plain language guidelines. Measure data accuracy
is of paramount importance to CMS. The measure data currently available
on Physician Compare was previewed by those group practices that
currently have 2012 PQRS GPRO data available on Physician Compare prior
to publication with no concerns raised regarding accuracy. Since being
published, no group practices with GPRO data have raised concerns
regarding the accuracy of the measure data available. To confirm, the
Web Interface reporting option will remain limited to groups of 25 or
more EPs. Smaller groups, groups of 2 to 24 EPs, can report under the
PQRS via EHR or Registry. We also clarify that group-level data is only
published at the group level--included on the group practice profile
page--on Physician Compare. And, in response to comments that raised
concern about measures reported in the first year, we have decided that
we will not publicly report a measure that is in its first year. By
first year we mean a measure that is newly available for reporting
under PQRS.
We also received comments specifically about EHR measures.
Comment: Commenters were opposed to publicly reporting EHR
measures, citing that it is too soon to publicly post performance data
from eCQMs without additional work to verify the validity and accuracy
of the measure results. One commenter suggested that new quality
measures could be piloted by health care professionals prior to
requiring their use within a federal program. One commenter strongly
encouraged developing a tutorial that allows the public to better
understand this data.
Response: We appreciate the commenters' feedback regarding
including measures collected via EHRs. Group practices will have the
ability to report measures via an EHR prior the 2015 data collection.
Therefore, this reporting mechanism will not be in its first year of
use at this time. As a result, we do not believe it is too soon to
report these quality measures. As noted, only comparable, valid,
reliable, and accurate
[[Page 67769]]
data will be included on Physician Compare. All measures slated for
public reporting will be consumer tested to ensure they are accurately
understood prior to publication. If concerns surface from this testing,
we will evaluate if the requirements for public reporting are not
suitably met and if the measure or measures in question should be
suppressed and not publicly reported to ensure only those measures that
are valid, reliable, and accurate and inform quality choice are
included on the site.
Given the value of these group-level data, and the successful
publication of such data to date, we are finalizing our proposal to
report all 2015 PQRS measures for all reporting options for group
practices of 2 or more EPs participating in PQRS GPRO, and all 2015
measures reported by ACOs. Consistent with this final policy, we are
making a conforming change to the regulation at Sec. 425.308(e) to
provide that all quality measures reported by ACOs will be reported on
Physician Compare in the same way as for group practices that report
under the PQRS.
We also proposed (79 FR 40389) that measures must meet the public
reporting criteria of a minimum sample size of 20 patients.
Comment: Several commenters supported the proposed minimum sample
size of 20 patients. However, the majority of commenters believed a
patient threshold of 20 is too low to be statistically valid, which
commenters claim may result in inaccurate quality scores based on one
outlier. Commenters recommended CMS use a higher threshold to ensure
validity. Several commenters also urged CMS to test measures and
composites with 20 patients and to provide an opportunity for public
comment and to review reliability and validity.
Response: We appreciate the commenters' feedback and understand the
concerns raised regarding the 20 patient minimum sample size. However,
we believe this threshold of 20 patients is a large enough sample to
protect patient privacy for reporting on the Web site, and aligns with
the reliability threshold previously finalized for the Value-Based
Modifier (VM) (77 FR 69166). As we continue to work to align quality
initiatives and minimize reporting burden on physicians and other
health care professionals, we are finalizing a patient sample size of
20 patients.
We proposed to include an indicator of which reporting mechanism
was used and to only include on the site measures deemed statistically
comparable.\8\ We received several comments regarding data
comparability, generally.
---------------------------------------------------------------------------
\8\ By statistically comparable, CMS means that the quality
measures are analyzed and proven to measure the same phenomena in
the same way regardless of the mechanism through which they were
collected.
---------------------------------------------------------------------------
Comment: Some commenters expressed concern with the comparability
of measures reported through different reporting mechanisms and
requested notation specifying the measure differences. One commenter
supported only publicly reporting measures with specifications
consistent across all reporting mechanisms, while another commenter
recommended that CMS group results by the data collection methodology
to improve comparability.
Response: Though we understand concerns regarding including
measures collected via different mechanisms, CMS is conducting analyses
to ensure that these measures align across different reporting
mechanisms. This analysis is done on a measure per measure basis. For
example, if a measure is reported via claims, then the measure
specifications would be aligned with a measure being reported via EHR
as long as it stays consistent with the original measure intent. Only
those measures that are proven to be comparable and most suitable for
public reporting will be included on Physician Compare and made
publicly available. Therefore, we are finalizing our proposal to report
data from the available reporting mechanisms and to include a notation
indicating which reporting mechanism was used.
We proposed (79 FR 40389) to publicly report all measures submitted
and reviewed and found to be statistically valid and reliable in the
Physician Compare downloadable file. However, we proposed that not all
of these measures necessarily would be included on the Physician
Compare profile pages. As we noted, consumer testing has shown profile
pages with too much information and/or measures that are not well
understood by consumers can negatively impact a consumer's ability to
make informed decisions. Our analysis of the collected measure data,
along with consumer testing and stakeholder feedback, will determine
specifically which measures are published on profile pages on the Web
site. Statistical analyses will ensure the measures included are
statistically valid and reliable and comparable across data collection
mechanisms. Stakeholder feedback will ensure all measures meet current
clinical standards. CMS will continue to reach out to stakeholders in
the professional community, such as specialty societies, to ensure that
the measures under consideration for public reporting remain clinically
relevant and accurate. When measures are finalized significantly in
advance of moment they are collected, it is possible that clinical
guidelines can change rendering a measure no longer relevant.
Publishing that measure can lead to consumer confusion regarding what
best practices their health care professional should be subscribing to.
As we noted in the proposed rule (79 FR 40389), the primary goal of
Physician Compare is to help consumers make informed health care
decisions. If a consumer does not properly interpret a quality measure
and thus misunderstands what the quality score represents, the consumer
cannot use this information to make an informed decision. Through
concept testing, CMS will test with consumers how well they understand
each measure under consideration for public reporting. If a measure is
not consistently understood and/or if consumers do not understand the
relevance of the measure to their health care decision making process,
CMS will not include the measure on the Physician Compare profile page
as inclusion will not aid informed decision making. Finally, consumer
testing will help ensure the measures included on the profile pages are
accurately understood and relevant to consumers, thus helping them make
informed decisions. This will be done to ensure that the information
included on Physician Compare is consumer friendly and consumer
focused.
Comment: Several commenters supported the proposal to have all 2015
measures available for download with only a select group of measures on
the Web site. One commenter further emphasized CMS should create
consistent formatting with Hospital Compare downloadable files.
Response: We appreciate the commenters' feedback and support for
this proposal. We are finalizing the proposal to include all measures
in a downloadable file and limiting the measures available on Physician
Compare profile pages to those measures that not only meet the
requirements of public reporting such as validity, reliability,
accuracy, and comparability, but that also are accurately understood
and interpreted by consumers as evidenced via consumer testing. This
will ensure that the measures presented on Physician Compare help them
make informed health care decisions without overwhelming them with too
much information. We will also take into future consideration the
[[Page 67770]]
recommendation regarding the Hospital Compare file.
We also received comments regarding stakeholder involvement and
consumer testing.
Comment: Commenters encouraged continued involvement of measure
developers and stakeholders in the public reporting development
process. Several commenters appreciated the continued collaboration
with specialty societies via town hall meetings and other mechanisms.
Several commenters advocated for more transparency by providing the
opportunity for the public to comment on the deliberations of the
Physician Compare TEP; regular engagement with interested stakeholders;
and increased communication about the measure consideration process,
including methods and interpretation of performance. Some commenters
appreciated that CMS will continue to reach out to stakeholders in the
professional community to ensure that the measures under consideration
for public reporting remain clinically relevant and accurate. One
commenter suggested an opportunity for stakeholder associations to
participate in the 30-day measure preview process.
Response: We appreciate the commenters' feedback regarding
stakeholder outreach and involvement in Physician Compare. As we noted,
section 10331(d) of the Affordable Care Act requires that the Secretary
take into consideration input provided by multi-stakeholder groups,
consistent with sections 1890(b)(7) and 1890A of the Act, as added by
section 3014 of the Act, in selecting quality measures for use on
Physician Compare. We also are dedicated to providing opportunities for
stakeholders to provide input. We will continue to identify the best
ways to accomplish this. We will also review all recommendations
provided for future consideration.
Comment: Many commenters supported consumer testing to ensure only
meaningful measures are included on the site. One commenter suggested
CMS first focus on communicating validated and meaningful information
in a user-friendly way. One commenter urged CMS to consult a broader
array of stakeholders during concept testing, while another commenter
specified the inclusion of health care professionals. Some commenters
requested that CMS share with professional associations or measure
developers any information obtained through consumer concept testing. A
few commenters asked for more details on concept testing plans, while
another recommended CMS use concept testing for the information
currently on the Physician Compare. One commenter emphasized testing
must occur prior to placing these additional measures on the Web site
in late 2016. One commenter believed health care professionals must be
aware of what measures will be reported to the Physician Compare Web
site before the reporting period begins.
Response: We appreciate the commenters' feedback. We will continue
to conduct consumer testing in terms of both usability testing--to
ensure the site is easy to navigate and functioning appropriately--and
concept testing--to ensure users understand the information included on
the Web site and that information included resonates with health care
consumers. We are continually working to test the information planned
for public reporting with consumers. We regularly test the information
currently on the Web site with site users. We are planning concept
testing of the measures being finalized in this rule prior to
publication in 2016 and we will work to ensure that valid, reliable,
and meaningful information is included on the Web site. This testing
ensures that the best information is shared and that it is shared in a
way that is correctly interpreted.
We will also engage stakeholders for feedback, including input from
the public, consumers, and health care professionals, as appropriate
and feasible through such opportunities as Town Halls, Listening
Sessions, Open Door Forums, and Webinars. We will review feedback for
future consideration. Although we establish in rulemaking the subset of
measures available for posting on the Physician Compare Web site, at
this time, however, it is not possible for us to provide stakeholders
with the exact list of measures that will be included on the Web site
prior to our analysis of the reported data to know which measures meet
the criteria we specified previously for public reporting.
As is the case for all measures published on Physician Compare,
group practices will be given a 30-day preview period to view their
measures as they will appear on Physician Compare prior to the measures
being published. As in previous years, we will detail the process for
the 30-day preview and provide a detailed timeline and instructions for
preview in advance of the start of the preview period. ACOs will be
able to view their quality data that will be publicly reported on
Physician Compare through the ACO Quality Reports, which will be made
available to ACOs for review at least 30 days prior to the start of
public reporting on Physician Compare.
Comment: Several commenters were in support of the 30-day preview
period prior to publication of quality data. Many commenters urged CMS
to also allow group practices, ACOs, and EPs the opportunity to correct
and/or appeal any errors found in the performance information before it
is posted on the Web site. Several commenters recommended CMS postpone
posting information if a group practice or EP files an appeal and flags
their demographic data or quality information as problematic. Other
commenters noted that a 30-day preview period is insufficient and
requested that CMS extend the period to 60 or 90 days. One commenter
believed the preview period should match the PQRS committee's measure
review timeline of 9 months. Some commenters sought clarification on
how CMS plans to notify EPs of the preview period and requested more
detail about correcting errors found during the preview period.
Response: We appreciate the commenters' feedback regarding the 30-
day preview period for quality measures on Physician Compare. Detailed
instructions regarding how to preview measure data, the time frame for
the measure preview, and directions for how to address any concerns or
get additional help during this process is shared at the start of the
preview period with all groups and individuals that have data to
preview. If an error is found in the measure display during this 30-day
preview, the directions explain how to contact the Physician Compare
team by both phone and email to have concerns addressed. Errors will be
corrected prior to publication. If measure data has been collected and
the measure has been deemed suitable for pubic reporting, the data will
be published. This 30-day period is in line with the preview period
provided for other public reporting programs such as Hospital Compare.
To date, our experience with this preview period for group practices
demonstrates that 30 days is sufficient time to allow for preview to be
conducted. It is important that quality data be shared with the public
as soon as possible so it is as current and relevant as possible when
published. To avoid further delaying this publication we will maintain
the 30-day preview period.
Group practices and EPs with available data for public reporting
will be informed via email when the preview period is going to take
place. Group practices and EPs will be provided instructions for
previewing data and information for on how to request help
[[Page 67771]]
or have questions answered. Additionally, information regarding the
preview period will be included on the Physician Compare Initiative
page on CMS.gov. As noted, ACOs will preview their data via their ACO
Quality Reports, which will be sent at least 30 days before data are
publicly reported. There is no preview period for demographic data.
These data are currently publicly available. If a group practice or EP
has questions about their demographic data, they should contact the
Physician Compare support team at [email protected].
In addition to making all 2015 PQRS GPRO measures available for
public reporting, we solicited comment (78 FR 40389) on creating
composites using 2015 data and publishing composite scores in 2016 by
grouping measures based on the PQRS GPRO measure groups, if technically
feasible. We indicated we would analyze the data collected in 2015 and
conduct psychometric and statistical analyses, looking at how the
measures best fit together and how accurately they are measuring the
composite concept, to create composites for certain PQRS GPRO measure
groups, including but not limited to:
Care Coordination/Patient Safety (CARE) Measures
Coronary Artery Disease (CAD) Disease Module
Diabetes Mellitus (DM) Disease Module
Preventive (PREV) Care Measures
In particular, we would analyze the component measures that make up
each of these measure groups to see if a statistically viable composite
can be constructed with the data reported for 2015. Composite scores
have proven to be beneficial in providing consumers a better way to
understand quality measure data, as composites provide a more concise,
easy to understand picture of physician quality.
Comment: Commenters were both positive and negative in regard to
our request for information on publicly reporting composite scores.
Some commenters stated composites should only be publicly reported if
statistically reliable, risk adjusted, or medically meaningful, and
should be scientifically or consumer tested prior to public display. A
few commenters also suggested NQF endorsement of individual components
and composites before finalizing any composites. Several commenters
strongly urged CMS to seek input from relevant specialty societies,
measure developers, consumers, and other stakeholders on the
construction and display of the composites. A few commenters opposed
public reporting of composites, but suggested providing physicians the
composite scores confidentially through the QRURs. Several commenters
noted concerns about the proposal to create composites given the
variability in the methodologies, difficulty validating the results,
and use of stand-alone measures developed to be reported individually.
One commenter suggested stand-alone measures are preferable to
composites in relatively small and heterogeneous measure sets. A few
commenters suggested posting additional information about composite
measures on Physician Compare clarifying that composite groups are not
readily available at this time for all measure groups. One commenter
urged CMS to retain more comprehensive information about the measures
within each composite measure in the downloadable file. One commenter
does not specifically support the Oncology Composite Score on Physician
Compare.
Response: We appreciate the commenters' feedback on this request
for information. We will be carefully reviewing all concerns raised and
recommendations made as we continue to evaluate options for including
composites in future rulemaking. This concept was put forth merely to
seek comment and no formal proposal was made, so we are not finalizing
any decisions regarding composite scores at this time. However, given
that we received feedback from stakeholders indicating such composite
scores are desired, we plan to analyze the data once it is collected to
establish the best possible composite, which would help consumers use
these quality data to make informed health care decisions, and will
consider proposing such composites in future rulemaking.
Similar to composite scores, benchmarks are also important to
ensuring that the quality data published on Physician Compare are
accurately interpreted and appropriately understood. A benchmark will
allow consumers to more easily evaluate the information published by
providing a point of comparison between groups. We continue to receive
requests from all stakeholders, but especially consumers, to add this
information to Physician Compare. As a result, we proposed (79 FR
40389) to publicly report on Physician Compare in 2016 benchmarks for
2015 PQRS GPRO data using the same methodology currently used under the
Shared Savings Program. This ACO benchmark methodology was previously
finalized in the November 2011 Shared Savings Program final rule (76 FR
67898), as amended in the CY 2014 PFS final rule with comment period
(78 FR 74759). Details on this methodology can be found on CMS.gov at
http://cms.gov/Medicare/Medicare-Fee-for-Service-Payment/sharedsavingsprogram/Downloads/MSSP-QM-Benchmarks.pdf. We proposed to
follow this methodology using the 2014 PQRS GPRO data.
We proposed to calculate benchmarks using data at the group
practice TIN level for all EPs who have at least 20 cases in the
denominator. A benchmark per this methodology is the performance rate a
group practice must achieve to earn the corresponding quality points
for each measure. Benchmarks would be established for each percentile,
starting with the 30th percentile (corresponding to the minimum
attainment level) and ending with the 90th percentile (corresponding to
the maximum attainment level). A quality scoring point system would
then be determined. Quality scoring would be based on the group
practice's actual level of performance on each measure. A group
practice would earn quality points on a sliding scale based on level of
performance: performance below the minimum attainment level (the 30th
percentile) for a measure would receive zero points for that measure;
performance at or above the 90th percentile of the performance
benchmark would earn the maximum points available for the measure. The
total points earned for measures in each measure group would be summed
and divided by the total points available for that measure group to
produce an overall measure group score of the percentage of points
earned versus points available. The percentage score for each measure
group would be averaged together to generate a final overall quality
score for each group practice. The goal of including such benchmarks
would be to help consumers see how each group practice performs on each
measure, measure group, and overall in relation to other group
practices.
Comment: Many commenters supported the use of benchmarks to help
consumers make informed health care decisions. However, several
commenters did not support the calculation of an overall quality score,
as they believe it will result in the unfair comparison of all group
practices. Additional commenters noted that benchmarks using
percentiles will be difficult for consumers to understand and
encouraged consumer testing to remedy this problem. Some commenters
noted appropriate methodology is needed when potential data constraints
impact the calculation of benchmarks. Several commenters also asked for
[[Page 67772]]
clarification on the impact of exception rates on quality scores and
how benchmarks will be displayed, noting the risk of arbitrary
thresholds potentially exaggerating minor performance differences. A
commenter asked for the opportunity to review sample data prior to
supporting the proposed methodology, while another noted that
benchmarks need to be set prior to the beginning of the new measurement
period. One commenter sought clarification on whether the benchmarking
methodology would be the same as the methodology applied under the
Value-Modifier. Several commenters urged CMS to use consistent
benchmarking across its programs to promote consistency and minimize
confusion. One commenter cautioned the use of benchmarks, noting it can
lead to an incomplete and potentially misleading indicator of quality.
Response: We appreciate the commenters' feedback on our proposal to
include on Physician Compare a benchmark for 2015 PQRS GPRO measures
(and measures reported by individual EPs) measures based on the current
Shared Savings Program benchmark methodology. Although we agree
benchmarks can add great value for consumers, we understand the many
concerns raised. As a result, we have made a decision not to finalize
this proposal at this time. We want to be sure to discuss more
thoroughly potential benchmarking methodologies with our stakeholders
prior to finalizing the proposal. We also want to evaluate other
programs' methodologies, including the Value Modifier, to work toward
better alignment across programs. We therefore feel it would be best to
forgo finalizing a methodology at this time in favor of a stronger,
potentially better aligned methodology that can be included in future
rulemaking.
Understanding the value consumers place on patient experience data
and the commitment to reporting these data on Physician Compare, we
proposed (79 FR 40390) publicly reporting in CY 2016 patient experience
data from 2015 for all group practices of two or more EPs, who meet the
specified sample size requirements and collect data via a CMS-specified
certified CAHPS vendor. The patient experience data available are
specifically the CAHPS for PQRS and CAHPS for ACO measures, which
include the CG-CAHPS core measures. For group practices, we proposed to
make available for public reporting these 12 summary survey measures:
Getting Timely Care, Appointments, and Information.
How Well Providers Communicate.
Patient's Rating of Provider.
Access to Specialists.
Health Promotion & Education.
Shared Decision Making.
Health Status/Functional Status.
Courteous and Helpful Office Staff.
Care Coordination.
Between Visit Communication.
Helping You to Take Medication as Directed.
Stewardship of Patient Resources.
We proposed that these 12 summary survey measures would be
available for public reporting for all group practices. For ACOs
participating in the Shared Savings Program, we proposed (79 FR 40390)
that the patient experience measures that are included in the Patient/
Caregiver Experience domain of the Quality Performance Standard under
the Shared Savings Program in 2015 would be available for public
reporting in 2016. We would review all quality measures after they are
collected to ensure that only those measures deemed valid and reliable
are included on the Web site.
We received a number of comments around our proposals to include
CAHPS measures on Physician Compare.
Comment: Several commenters supported our proposal to publicly
report CAHPS for PQRS data for all group practices that have met the
minimum sample size requirements and collect the data using a certified
CMS-approved vendor. One commenter strongly encouraged CMS to make
public reporting on patient experience measures mandatory for groups of
all sizes and individual EPs. However, a few commenters were concerned
with public reporting of CAHPS or other patient experience survey data
due to the subjectivity of the surveys or the cost of administering the
surveys.
Response: We appreciate the commenters' feedback. At this time
reporting of CAHPS measures for PQRS is only available at the group
practice level, so we will continue to consider these data for group
practices. We understand the concerns raised regarding subjectivity and
cost. However, we are confident that CAHPS is a well-tested collection
mechanism that produces valid and comparable measures of physician
quality based on the extensive testing and work that has been done by
the Agency for Healthcare Research and Quality's (AHRQ) and
specifically the CAHPS Consortium (for more information visit https://cahps.ahrq.gov/). This work illustrates that these measures are
accurate measures of patient experience. Because CAHPS for PQRS can be
one part of a group's participation in PQRS and are data greatly
desired by consumers, we also believe concerns regarding cost are
outweighed. For these reasons, we are finalizing our proposal to make
available for public reporting the 12 summary survey CAHPS measures
outlined in this rule on Physician Compare for group practices and
ACOs, as appropriate.
Comment: Commenters were generally supportive of the proposal to
publicly report 12 summary CAHPS scores; however, some are concerned
that several CAHPS summary survey measures cannot accurately capture
aspects of care over which an individual physician does not have direct
control, such as ``Getting Timely Care, Appointments and Information''
and ``Access to Specialists,'' and urged CMS to only report these
measures on an aggregate, group level. Another commenter is concerned
with ``Stewardship of Patient Resources'' survey measure, noting that
it is not a physician's role to manage a patient's pocketbook and that
other barriers, apart from costs, can impede access to care.
One commenter supported the creation of benchmarks for CAHPS for
PQRS measures, and suggested CMS clarify whether those benchmarks will
be the same as the ACO CAHPS measure benchmarks, or whether the
benchmarks will be specific to the PQRS program, but calculated using
the same methodology.
Response: The CAHPS for PQRS measures are designed to be group-
level measures. These data will not be calculated for individual EPs;
they will be evaluated at the group practice level. We do appreciate
the commenters' feedback regarding concerns over specific measures. One
important consideration is that because the CAHPS measures are group-
level, they are not attributing aspects of care to an individual EP, as
not all aspects of care can be easily attributed to a single
professional. Prior to deciding the specific measures that will be
publicly reported on Physician Compare, we will ensure the measures
meet the reliability and validity requirements set for public reporting
and that the measures are understood and accurately interpreted by
consumers. If a summary survey measure does not meet these criteria, it
will not be publicly reported on Physician Compare. At this time, we
are not adopting any benchmarks for CAHPS for PQRS on Physician
Compare.
Comment: One commenter sought additional information on how CAHPS
for PQRS performance measures will be displayed. Another commenter
suggested that public reporting of
[[Page 67773]]
CAHPS for PQRS utilize the Hospital Compare model by displaying
aggregate scores for measures with a footnote or click-through option
to view the performance data.
Response: We appreciate the commenters' feedback regarding display
of CAHPS for PQRS measures. We generally make decisions about measure
display after consumer testing and stakeholder outreach, so we will
take these recommendations into consideration.
We previously finalized in the 2014 PFS final rule with comment
period (78 FR 74454) that 20 measures in the 2014 PQRS measures for
individual EPs collected via registry, EHR, or claims would be
available for public reporting in late 2015, if technically feasible.
We proposed (79 FR 40390) to expand on this in two ways. First, we
proposed to publicly report these same 20 measures for 2013 PQRS data
in early 2015. We stated that publicly reporting these 2013 individual
measures would help ensure individual level measures are made available
as soon as possible. We believe that consumers are looking for measures
about individual doctors and other health care professionals, and this
would make these quality data available to the public sooner.
Comment: One commenter supported our proposal to publicly report 20
individual EP-level 2013 PQRS measures in early 2015, while another
commenter opposed the proposal noting that physicians were unaware at
the time of data collection that these performance rates would be
published. Concerns were raised that timelines needed to be finalized
before the public reporting period had ended.
Response: We appreciate the commenters' feedback and understand
concerns that the 2013 individual EP PQRS data were submitted without
an explicit understanding that these data would be made public. As a
result, we are not finalizing this proposal.
Second, we proposed (79 FR 40390) to make all individual EP-level
PQRS measures collected via registry, EHR, or claims available for
public reporting on Physician Compare for data collected in 2015 to be
publicly reported in late CY 2016, if technically feasible.\9\ We
stated that this would provide the opportunity for more EPs to have
measures included on Physician Compare, and it would provide more
information to consumers to make informed decisions about their health
care. As with group-level measures, we proposed to publicly report all
measures submitted and reviewed and deemed valid and reliable in the
Physician Compare downloadable file. However, not all of these measures
necessarily would be included on the Physician Compare profile pages.
Our analysis of the reported measure data, along with consumer testing
and stakeholder feedback, would determine specifically which measures
are published on profile pages on the Web site. In this way, quality
information on individual practitioners would be available, as has been
regularly requested by Medicare consumers, without overwhelming
consumers with too much information.
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\9\ Tables Q1-Q27 detail proposed changes to available PQRS
measures. Additional information on PQRS measures can be found on
the CMS.gov PQRS Web site at http://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/PQRS/index.html.
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Comment: Some commenters supported expanding public reporting of
individual-level quality measures to all 2015 PQRS measures collected
through a Registry, EHR, or claims, noting consumers are looking for
individual doctors so this information is helpful. Several commenters
opposed making 2015 PQRS individual EP measures available for public
reporting in 2016 and are concerned that individual quality measurement
is technically challenging to validate and may be difficult for
consumers to understand. Another commenter suggested it is too much
information for consumers. One commenter stated that data reported
through different reporting mechanisms is not comparable so this
proposal should not be finalized. One commenter believed that the
relatively small numbers of patients seen by individual physicians
raises questions about the ability to truly differentiate quality.
Several commenters supported group practice level public reporting as
an alternative to individual public reporting.
Response: We appreciate the commenters' feedback and agree with
those comments that support individual-level measure data should be
posted on the site as soon as technically feasible. We also strongly
agree with commenters that these data will help health care consumers
make informed decisions about the care they receive. However, we
appreciate the concerns raised by other commenters' in opposition to
posting individual EP measures. We are committed to including only the
most accurate, statistically reliable, and valid quality of care
measure data on Physician Compare. We will also ensure that only those
data that are evaluated to be comparable will be publicly reported
understanding the concerns regarding data collected via different
reporting mechanisms.
We will continue to test the PQRS measures with consumers to ensure
the measures are presented and described in a way that is accurately
understood. We will only include on the Web site those measures that
resonate with consumers to ensure they are not overwhelmed with too
much information. Regarding concerns around the number of patients
seen, only those measures that are reported for the accepted sample
size of 20 patients will be publicly reported. Because of the
overwhelming consumer demand for individual EP data and the value these
data provide to patients, we are finalizing our proposal to publicly
report all 2015 individual EP PQRS measures collected through a
Registry, EHR, or claims, except for those measure that are new to PQRS
and thus in their first year.
As noted above for group-level reporting, composite scores and
benchmarks are critical in helping consumers best understand the
quality measure information presented. For that reason, in addition to
making all 2015 PQRS measures available for public reporting, we sought
comment (79 FR 40390) to create composites and publish composite scores
by grouping measures based on the PQRS measure groups, if technically
feasible. We indicated that we would analyze the data collected in 2015
and conduct psychometric and statistical analyses to create composites
for PQRS measure groups to be published in 2016, including:
Coronary Artery Disease (CAD) (see Table 30)
Diabetes Mellitus (DM) (see Table 32)