[Federal Register Volume 79, Number 133 (Friday, July 11, 2014)]
[Proposed Rules]
[Pages 40318-40540]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2014-15948]
[[Page 40317]]
Vol. 79
Friday,
No. 133
July 11, 2014
Part III
Department of Health and Human Services
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Centers for Medicare & 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; Proposed Rule
Federal Register / Vol. 79 , No. 133 / Friday, July 11, 2014 /
Proposed Rules
[[Page 40318]]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Medicare & Medicaid Services
42 CFR Parts 403, 405, 410, 414, 425, and 498
[CMS-1612-P]
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: Proposed rule.
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SUMMARY: This major proposed rule 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 proposed rule.
DATES: Comment date: To be assured consideration, comments must be
received at one of the addresses provided below, no later than 5 p.m.
on September 2, 2014.
ADDRESSES: In commenting, please refer to file code CMS-1612-P. 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-P, P.O. Box 8013,
Baltimore, MD 21244-8013.
Please allow sufficient time for mailed comments to be received
before the close of the comment period.
3. By express or overnight mail. You may send written comments to
the following address ONLY: Centers for Medicare & Medicaid Services,
Department of Health and Human Services, Attention: CMS-1612-P, 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: Gail Addis, (410) 786-4552, for issues
related to the refinement panel or for any physician payment issues not
identified below.
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.
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, for issues related to local
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.
Rashaan Byers, (410) 786-2305, 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.
SUPPLEMENTARY INFORMATION:
Inspection of Public Comments: All comments received before the
close of the comment period are available for viewing by the public,
including any 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,
[[Page 40319]]
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 Proposed Rule 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. Chronic Care Management (CCM)
H. Definition of Colorectal Cancer Screening Tests
I. Payment of Secondary Interpretation of Images
J. Conditions Regarding Permissible Practice Types for
Therapists in Private Practice
K. Payments for Physicians and Practitioners Managing Patients
on Home Dialysis
III. Other Provisions of the Proposed Regulations
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 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
IV. Collection of Information Requirements
V. Response to Comments
VI. Regulatory Impact Analysis
Regulations Text
Acronyms
In addition, because of the many organizations and terms to which
we refer by acronym in this proposed rule, 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 2013 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
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
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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 proposed rule 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 proposed rule, refer
to item CMS-1612-P. Readers who experience any problems accessing any
of the Addenda or other documents referenced in this proposed rule and
posted on the CMS Web site identified above should contact
[email protected].
CPT (Current Procedural Terminology) Copyright Notice
Throughout this proposed rule, 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 proposed rule would revise payment polices under the
Medicare Physician Fee Schedule (PFS) and make other policy changes
related to Medicare Part B payment. These changes would be applicable
to services 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 proposed rule, we propose 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 proposed rule 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 to Core-Based Statistical Areas 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 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. The most significant impacts are for
radiation therapy centers and radiation oncology for which there would
be decreases of 8 and 4 percent, respectively. These reductions
primarily stem from a proposal discussed in section II.A. to consider
an equipment item as indirect rather than direct practice expense.
Payment for chronic care management (CCM) services is projected to have
a positive effect on family practice, internal medicine, and
geriatrics. This proposed rule includes new proposed MP RVUs based upon
CY 2015 five-year review of MP RVUs. For most specialties, the proposed
revisions for the five-year review of MP RVUs would result in minor
overall changes in RVUs, with only ophthalmology (-2 percent) having a
projected change of at least 2 percent.
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 proposed rule, 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
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
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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 proposed rule.
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 proposed rule includes a
proposal for a five-year review for CY 2015.
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.1. of this proposed rule, in
accordance with section 1848(c)(2)(B)(ii)(II) of the Act, if revisions
to the RVUs would cause expenditures for the year to change by more
than $20 million, we make
[[Page 40322]]
adjustments to ensure that expenditures do 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 proposed
rule 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.
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
[[Page 40323]]
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.2 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 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 their 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
electronic health records (EHRs) and other types of health information
technology (HIT) across the broader care continuum through a number of
initiatives including: (1) Alignment of incentives and payment
adjustments to encourage provider adoption and optimization of HIT 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 networks. 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 ONC's HIT
Certification Program and expand HIT certification, ONC has issued a
proposed rule concerning a voluntary 2015 Edition of EHR certification
criteria, which would more easily accommodate the certification of HIT
used in all health care settings where health care providers are not
typically eligible for incentive payments under the EHR Incentive
Programs, to facilitate greater HIE across the entire care continuum.
We believe that HIE and the use of certified EHRs can effectively and
efficiently help 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). More information on the Voluntary 2015 Edition EHR
Certification Criteria proposed rule is available at http://healthit.gov/policy-researchers-implementers/standards-and-certification-regulations.
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 MP 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.
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).
[[Page 40324]]
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 with respect to 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, equipment, and supplies) 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 proposed rule 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 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,
[[Page 40325]]
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 under the bottom-up methodology.)
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 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 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 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
[[Page 40326]]
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 NPPs 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 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........................ Bilateral Surgery....... 150%......................... 150% of work time.
LT and RT....................
51........................... Multiple Procedure...... 50%.......................... Intraoperative portion.
[[Page 40327]]
52........................... Reduced Services........ 50%.......................... 50%.
53........................... Discontinued Procedure.. 50%.......................... 50%.
54........................... Intraoperative Care only Preoperative + Intraoperative Preoperative +
Percentages on the payment Intraoperative portion.
files used by Medicare
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 (MPPRs). 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
proposed rule with comment period.
(6) Equipment Cost Per Minute
The equipment cost per minute is calculated as:
(1/(minutes per year * usage)) * price * ((interest rate/(1-(1/((1 +
interest rate)- life of equipment)))) + maintenance)
Where:
minutes per year = maximum minutes per 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 solicit comment regarding reliable data on maintenance
costs that vary for particular equipment items.
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 solicit comment on adjusting
our cost formula to include equipment costs that do not vary based on
the equipment time.
Interest Rate: In the CY 2013 final rule with comment period (77 FR
68902), we updated the interest rates used in developing an equipment
cost per minute calculation. The interest rate was based on the 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
(percent)
------------------------------------------------------------------------
<$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
------------------------------------------------------------------------
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,
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 0.00 5.10 5.10 0.00
(2) Supply cost (Sup)............. Step 1.......... AMA................. .................... 2.98 7.34 .53 .53 0.00 1.19 1.19 0.00
(3) Equipment cost (Eqp).......... Step 1.......... AMA................. .................... 0.17 0.58 6.92 6.92 0.00 0.09 0.09 0.00
(4) Direct cost (Dir)............. Step 1.......... .................... =(1)+(2)+(3)........ 16.48 85.45 13.19 13.19 0.00 6.38 6.38 0.00
(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....... =Lab * Dir Adj...... =(1)*(5)............ 7.86 45.72 3.39 3.39 0.00 3.01 3.01 0.00
(7) Adjusted Supplies............. Steps 2-4....... =Eqp * Dir Adj...... =(2)*(5)............ 1.76 4.33 .31 .31 0.00 .70 .70 0.00
(8) Adjusted Equipment............ Steps 2-4....... =Sup * Dir Adj...... =(3)*(5)............ .10 0.34 4.08 4.08 0.00 0.05 0.05 0.00
(9) Adjusted Direct............... Steps 2-4....... .................... =(6)+(7)+(8)........ 9.72 50.40 7.78 7.78 0.00 3.77 3.77 0.00
(10) Conversion Factor (CF)....... Step 5.......... PFS................. .................... 35.8228 35.8228 35.8228 35.8228 35.8228 35.8228 35.8228 35.8228
(11) Adj. labor cost converted.... Step 5.......... =(Lab * Dir Adj)/CF. =(6)/(10)........... 0.22 1.28 0.09 0.09 0.00 0.08 0.08 0.00
(12) Adj. supply cost converted... Step 5.......... =(Sup * Dir Adj)/CF. =(7)/(10)........... 0.05 0.12 0.01 0.01 0.00 0.02 0.02 0.00
(13) Adj. equipment cost converted Step 5.......... =(Eqp * Dir Adj)/CF. =(8)/(10)........... 0.00 0.01 0.11 0.11 0.00 0.00 0.00 0.00
(14) Adj. direct cost converted... Step 5.......... .................... =(11)+(12)+(13)..... 0.27 1.41 0.22 0.22 0.00 0.11 0.11 0.00
(15) Work RVU..................... Setup File...... PFS................. .................... 0.97 33.75 0.22 0.00 0.22 0.17 0.00 0.17
(16) Dir--pct..................... Steps 6,7....... Surveys............. .................... 0.25 0.17 0.29 0.29 .29 .29 .29 .29
(17) Ind--pct..................... Steps 6,7....... Surveys............. .................... 0.75 .83 .71 .71 .71 .71 .71 .71
(18) Ind. Alloc. Formula (1st Step 8.......... See Step 8.......... .................... ((14)/ ((14)/ ((14)/ ((14)/ ((14)/ ((14)/ ((14)/ ((14)/
part). (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 .53 .53 0 0.26 0.26 0
(20) Ind. Alloc. Formula (2nd Step 8.......... See Step 8.......... .................... (15) (15) (15+11) (11) (15) (15+11) (11) (15)
part).
(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 + Step 8.......... .................... =(19)+(21).......... 1.79 40.42 .84 .62 0.22 0.51 0.34 0.17
2nd).
[[Page 40328]]
(23) Indirect Adjustment (Ind. Steps 9-11...... See Footnote**...... .................... .3813 .3813 .3813 .3813 .3813 .3813 .3813 .3813
Adj.).
(24) Adjusted Indirect Allocator.. Steps 9-11...... =Ind Alloc * Ind Adj .................... 0.68 15.41 .32 .24 0.08 0.20 0.13 .06
(25) Ind. Practice Cost Index Steps 12-16..... .................... .................... 1.07 0.75 .99 .99 .99 0.91 0.91 0.91
(IPCI).
(26) Adjusted Indirect............ Step 17......... = Adj.Ind Alloc * =(24)*(25).......... 0.73 11.59 .32 .24 0.08 0.18 0.12 0.06
PCI.
(27) PE RVU....................... Step 18......... =(Adj Dir + Adj Ind) =((14)+(26)) * Other 1.01 13.05 .53 .45 .08 .29 .23 0.06
* Other Adj. Adj).
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
* 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 this table to illustrate the PE calculation has no effect on the resulting RVUs.
3. Changes to Direct PE Inputs for Specific Services
In this section, we discuss other CY 2015 proposals and revisions
related to direct PE inputs for specific services. The proposed direct
PE inputs are included in the proposed rule CY 2015 direct PE input
database, which is available on the CMS Web site under downloads for
the CY 2015 PFS proposed rule 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 propose to accept, without
refinement, the RUC recommendation to adjust these clinical labor
minutes as indicated in Table 5 as ``Change to Clinical Labor Time.''
The CY 2015 direct PE database reflects these proposed changes 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 5--Codes With Proposed Changes to Post-Procedure Clinical Labor Monitoring Time
----------------------------------------------------------------------------------------------------------------
RUC recommended
Current total post- Change to
CPT code monitoring time procedure clinical labor
(min) monitoring time time (min)
(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
----------------------------------------------------------------------------------------------------------------
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 future recommendations
would use 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
[[Page 40329]]
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 these services. Therefore,
we propose 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 proposed revised moderate
sedation input package would be applied to relevant codes as we review
them through future notice and comment rulemaking. 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.
c. RUC Recommendation for Migration From Film to Digital Practice
Expense Inputs
The RUC has 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
that 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, we are
unable to determine the appropriate pricing to use for the inputs. We
propose 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, we propose 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 propose to allocate the full clinical labor intraservice time to
ED021, except when there is no clinical labor, in which case we propose
to allocate the intraservice work time to ED021. For services valued
only in the facility setting, we propose 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 Proposed To Be
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
proposed 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 proposed change to digital inputs would take
effect beginning January 1, 2015. We also believe 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 seek comment on whether the computer workstation,
which we propose 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.
[[Page 40330]]
91120........................... Rectal sensation test.
91122........................... Anal pressure record.
91132........................... Electrogastrography.
91133........................... Electrogastrography w/test.
92521........................... Evaluation of speech fluency.
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 note 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 agree 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 recognize 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 are 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 refer 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 are
displaying this information as we attempt to increase the transparency
of the direct PE database. We hope that this modification could 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 are seeking
comments on the feasibility of this approach. We note that we are not
proposing to make any changes to PE inputs for CY 2015 based on this
proposed modification to the design of the direct PE input database.
The CY 2015 direct PE database reflects these proposed changes 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/.
d. Inputs for Digital Mammography Services
Mammography services are currently reported by and paid for 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 the G-codes for 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 pay for mammography billed using
the CPT codes when the services were furnished with film technology
(77055 mammogram one breast; 77056 mammogram both breasts; 77057
mammogram screening). 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 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 what the
RUC has indicated regarding the use of digital technology. It appears
that the typical mammography service is furnished using digital
technology. As such, we do not believe there is a reason to continue
the separate use of the CPT codes and the 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 are
proposing to delete the mammography G-codes beginning for CY 2015 and
to pay all mammography using the CPT codes.
Although we believe that the CPT codes should now be used to report
all mammography services, we have 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 significant technological changes have
occurred during this time, we do not believe it would be appropriate to
retain the current values for the CPT codes. Therefore, we are
proposing to value the CPT codes using the RVUs previously established
for the G-codes. We believe 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.3.b.(4) of this proposed rule, we are
proposing these CPT codes as potentially misvalued and requesting that
the RUC and other interested stakeholders review these services in
terms of appropriate work RVUs, work time assumptions and direct PE
inputs.
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. Moreover, it is difficult to distinguish the cost of the vault
from the cost of the building. In response to this action, 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 believe 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
[[Page 40331]]
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 do not represent direct
medical equipment costs in our established PE methodology. Therefore we
believe 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 infrastructure costs based on equipment
needs Therefore, we propose to remove the radiation treatment vault as
a direct PE input from the radiation treatment procedures listed in
Table 8, because we believe that the vault is not, itself, medical
equipment, and therefore, is accounted for in the indirect PE
methodology.
Table 8--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.
------------------------------------------------------------------------
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 are
proposing a correction to the clinical labor type for this service.
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 are proposing to move the
RN time allocated to these procedures to the facility setting. The PE
RVUs listed in Addendum B reflect these technical corrections.
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 proposed 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 proposed rule 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.
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 propose 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 previously stated our difficulty in obtaining accurate
pricing information. We have also made clear that 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 note that we continue to have difficulty determining the best
way to use the invoices that we receive. In all cases, we attempt to
use the price that appears most representative, but it can be difficult
to ascertain whether the prices on particular invoices are typical. For
example, in some cases, we receive multiple invoices, but are only able
to use one of them because the other invoices include additional items
and do not separately identify the price of the item in question. In
other cases, we receive multiple invoices at one price, which suggests
that this price is likely a typical one. In other cases, we receive
invoices for items already in the direct PE database that are based on
a recent invoice. In these cases, it is not clear whether the new,
usually higher priced, invoice reflects a more accurate price than the
current price, but we need to determine whether to substitute the new
price for the existing price, maintain the existing price, or average
the two prices. We continue to seek stakeholder input on the best
approach to using the small sample of invoices that are provided to us
through this process.
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
[[Page 40332]]
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 are proposing to
update the prices for both of these items based on these
recommendations. The CY 2015 direct PE database reflects these proposed
changes 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/.
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 9. We propose to accept this recommendation, but seek 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 proposed
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 9--Standard Contrast Imaging Supply Package
----------------------------------------------------------------------------------------------------------------
Medical supply description CMS supply code Unit Quantity Price
----------------------------------------------------------------------------------------------------------------
Imaging w/Contrast--Standard Package
----------------------------------------------------------------------------------------------------------------
Kit, IV starter................... SA019................ Kit.................. 1 $1.368
Gloves, non-sterile............... SB022................ Pair................. 1 0.084
Angiocatheter 14g-24g............. SC001................ Item................. 1 1.505
Heparin lock...................... SC012................ Item................. 1 0.917
IV tubing (extension)............. SC019................ Foot................. *3 1.590
Needle, 18-27g.................... SC029................ Item................. 1 0.089
Syringe 20ml...................... SC053................ Item................. 1 0.558
Sodium chloride 0.9% inj. SH068................ Item................. 1 0.700
bacteriostatic (30ml uou).
Swab-pad, alcohol................. SJ053................ Item................. 1 0.013
-------------------------------
TOTAL......................... ..................... ..................... .............. 6.824
----------------------------------------------------------------------------------------------------------------
* The price for SC019 (IV tubing, (extension)) is $0.53 per foot.
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
these codes in future rulemaking.
Most commenters suggested 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 have no
indication that the direct PE inputs included in the CPT codes do not
reflect the typical resource inputs involved in furnishing an SRS
service. Therefore, we propose to recognize only the CPT codes for
payment of SRS services, and to delete the G-codes used to report
robotic delivery of SRS.
k. Inclusion of Capnograph for Pediatric Polysomnography Services
We are proposing to include equipment item EQ358, Sleep capnograph,
polysomnography (pediatric), for CPT codes 95782 (Polysomnography;
younger than 6 years, sleep staging with 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). We understand that capnography is a required element of
sleep studies for patients younger than 6 years, and propose 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 propose to price EQ358 at $4,534.23.
l. Nonfacility Direct PE Inputs for Intravascular Ultrasound
A stakeholder requested that we establish nonfacility PE RVUs for
CPT code 37250 (Intravascular ultrasound (non-coronary vessel) during
diagnostic evaluation and/or therapeutic intervention; each additional
vessel (List separately in addition to code for primary procedure)) and
37251 (Intravascular ultrasound (non-coronary vessel) during diagnostic
evaluation and/or therapeutic intervention; each additional vessel
(List separately in addition to code for primary procedure)). We seek
comment regarding whether it is appropriate to have nonfacility PE RVUs
for this code and if so what inputs should assigned to this code.
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, we have several longstanding
concerns regarding the accuracy of direct PE inputs, including
[[Page 40333]]
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
note 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 CY 2014 rulemaking 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 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 are not proposing 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 a 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) 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 proposed rule, 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 experience has also 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 also 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.
Section 220 of the PAMA also provides authority to use alternative
approaches to establish practice expense 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 many stakeholders will have concerns regarding the possibility of
using hospital outpatient cost data in developing PFS PE RVUs, and we
want to be sure we are aware of these prior to considering or
developing any future proposal relying on those data. Therefore, we are
seeking 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 note 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 are particularly interested 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 urge 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.
In addition to soliciting comments as noted above, we continue to
seek a better understanding regarding the growing trend toward hospital
acquisition of physician offices and
[[Page 40334]]
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 physician 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 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 does 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 addressed this issue as it relates to
accurate valuation of visits within the post-operative period of 10-
and 90-day global codes in section II.B.4 of this proposed rule.
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
(73 FR 43302). 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 believe 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 physician
and hospital services furnished in an off-campus provider-based
department of a hospital. 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 are proposing 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
1834(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 are seeking
additional comment on whether a code modifier is the best mechanism for
collecting this service-level information.
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 MP. Section 1848(c)(1)(A) of the Act defines the work
component to include ``the portion of the resources used in furnishing
the service that reflects work 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 proposed rule 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 proposed rule 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) to 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 proposed rule, 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), MedPAC, and
others. For many years, the RUC has provided us with recommendations on
the appropriate
[[Page 40335]]
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 PFS, 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 the initial recommendations, ``CMS
and the RUC have taken several steps to improve the review process.''
Also, since that time 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 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;
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 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 PFS.
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 in these areas over the upcoming
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 the 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
[[Page 40336]]
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 and have listed work time).
In the CY 2014 final rule with comment period, we finalized for
review a list of potentially misvalued services that included
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
evaluation and management (E/M) visit information and work time for
approximately 100 global surgery codes. In CY 2014, we also considered
a proposal to limit Medicare PFS payments for services furnished in a
nonfacility setting when the PFS payment would exceed the combined
Medicare payment under the PFS to the practitioner and facility payment
made to either the ASC or hospital outpatient. 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 in section II.A. of this proposed rule.
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 to be appropriate to facilitate
the validation of RVUs of services.
In the CY 2011 PFS proposed rule (75 FR 40068) and CY 2012 PFS
proposed rule (76 FR 42790), we solicited public comments on possible
approaches, methodologies, and data sources that we should consider for
a validation process. A summary of the comments along with our
responses are included in the CY 2011 PFS final rule with comment
period (75 FR 73217) and the CY 2012 PFS final rule with comment period
(73054 through 73055).
Since that time, we have 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 for PFS services. The Urban Institute
will use a variety of approaches to develop objective time estimates,
depending on the type of service. Objective time estimates will be
compared to the current time values used in the fee schedule. The
project team will then convene groups of physicians from a range of
specialties to review the new time data and their potential
implications for work and the ratio of work to time. In its efforts to
collect primary data on the time involved in PFS services, the Urban
Institute has encountered numerous challenges. An interim report,
Development of a Model for the Valuation of Work Relative Value Units,
discusses the challenges encountered in collecting objective time data
and offers some thoughts on how these can be overcome. This interim
report is on the CMS Web site at http://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/PhysicianFeeSched/Downloads/RVUs-Validation-Urban-Interim-Report.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.
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.
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
[[Page 40337]]
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, Department of Veteran Affairs (VA)
National Surgical Quality Improvement Program (NSQIP), the Society for
Thoracic Surgeons (STS) National Database, and the Physician Quality
Reporting System (PQRS) databases).
National surveys of work time and intensity from
professional and management societies and organizations, such as
hospital associations.
We evaluate the supporting documentation submitted with the
nominated codes 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. The public has the opportunity to
comment on these and all other proposed potentially misvalued codes. In
that year's final rule, we finalize our list of potentially misvalued
codes.
During the comment period on the CY 2014 final rule with comment
period, we received nominations and supporting documentation for two
codes to be considered as potentially misvalued codes. We evaluated the
supporting documentation for each nominated code to ascertain whether
the submitted information demonstrated that the code should be proposed
as potentially misvalued.
CPT code 41530 (submucosal ablation of the tongue base,
radiofrequency, 1 or more sites, per session) was nominated for review
as a potentially misvalued code. The nominator stated that CPT code
41530 is misvalued because there have been changes in the PE items used
in furnishing the service. The nominator specifically requested that
the SD109 probe (probe, radiofrequency, 3 array (StarBurstSDE)) be
replaced with a more typically used probe, which costs less, and that a
replacement be used for equipment code EQ214 (radiofrequency generator)
to reflect a more appropriate input based on current invoices. We are
proposing this code as a potentially misvalued code.
CPT code 99174 (instrument-based ocular screening (eg,
photoscreening, automated-refraction), bilateral) was also nominated
for review as a potentially misvalued code. The nominator asserted that
CPT code 99174 is misvalued because of outdated capital equipment
inputs and the removal of supply code SK110 (fee, image analysis) from
the code's direct PE inputs. (The latter change was proposed and
finalized during CY 2014 notice and comment rulemaking). In
establishing our public nomination process, we specified that the we
would only consider nominations of active codes that are covered by
Medicare at the time of the nomination stating, ``We also are limiting
the review of RVUs to codes that are active, covered by Medicare, and
for which the RVUs are used for payment purposes under the PFS so that
resources are not expended on the review of codes with RVUs that have
no financial impact on the PFS.'' (76 FR 73059). CPT code 99174 is non-
covered on the PFS and therefore does not meet the criteria for review
as a potentially misvalued code. Accordingly, we are not proposing CPT
code 99174 as a potentially misvalued code.
b. Potentially Misvalued Codes
(1) Review of High Expenditure Services Across Specialties With
Medicare Allowed Charges of $10,000,000 or More
We are proposing the approximately 65 codes listed in Table 10 as
potentially misvalued codes as a prioritized subset of codes of the
newly established statutory category, ``codes that account for the
majority of spending under the physician fee schedule.'' As we identify
potentially misvalued codes, we prioritize codes that are important to
the Medicare program and its beneficiaries, and codes that account for
a high level of Medicare expenditures meet this criterion. However,
through our usual identification potentially misvalued codes it is
possible to miss certain services that are important to a segment of
Medicare practitioners and beneficiaries because the specialty that
typically furnishes the service does not have high volume relative to
the overall PFS utilization. To capture such services in developing
this list, we looked at high expenditure services by specialty using a
similar approach to the one we used in CY 2012. We believe it is
appropriate to repeat this type of analysis periodically.
To develop the CY 2015 proposed list in this category, we began by
identifying the top 20 codes by specialty in terms of allowed charges.
For this analysis, we used the same specialties as used for the impact
analysis in section VI. of this proposed rule. We excluded codes from
our proposed potentially misvalued list that we have reviewed since CY
2009, with fewer than $10 million in allowed charges, and that describe
anesthesia or E/M services. We excluded E/M services from the list of
proposed potentially misvalued codes for the same reasons that we
excluded them in the CY 2012 analysis, which we explained in the CY
2012 final rule with comment period (76 FR 73062 through 73065).
We believe that a review of the codes in Table 10 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 are proposing the codes listed in
Table 10 as potentially misvalued.
Table 10--Proposed Potentially Misvalued Codes Identified Through High
Expenditure 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.
[[Page 40338]]
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.
------------------------------------------------------------------------
(2) Epidural Injection and Fluoroscopic Guidance--CPT Codes 62310,
62311, 62318, 62319, 77001, 77002 and 77003
For CY 2014, we established interim final values 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 below 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 since the last time they were valued 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 believed that 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 62310, 62311, and 62318 and a portable C-arm for 62319.
We received thousands of comments objecting to the CY 2014 interim
final values for these codes, many citing concerns with patient access
and with the potential for the payment reductions under the PFS to
inappropriately incentivize the use of the hospital setting or to
encourage the use of other injections. Some suggested these payment
rates might affect the rate of opioid use. Although most comments did
not address the accuracy of the relative value inputs used in
determining PFS payment rates, those that did most often objected to
our valuations of the work RVUs and recommended that we instead accept
the RUC recommendations. Several commenters objected to our rationale
for setting the interim final work RVUs lower than the RUC-recommended
values primarily based upon the reduction in time. Commenters gave two
primary reasons why this reduction was inappropriate. Some pointed out
that a reduction in work based upon a reduction in time presumes that
the existing time is correct. These commenters asserted that the
existing times were not correct for these codes. For example, the RUC
noted that the CY 2013 survey times were from the original 1999 survey
and were an outlier when compared to the previously reported code's
original Harvard-valued total time of 42 minutes. One commenter noted
that CMS indicates that in setting work values, the agency considers
time, mental effort, professional judgment, technical skill, physical
effort and stress due to risk; but in this case, rather than following
our process, we only considered time. Others also said that we did not
take into account the intensity, complexity, or risk of performing
epidural injections. Commenters disagreed with the use of the lowest
RUC survey value as the basis for the work valuation. One commenter
said that we failed to explain adequately why our work RVUs were below
those recommended by the RUC. One recommended that we assign values
more similar to those used for paravertebral injections.
Two commenters stated that critical PE inputs, including an
epidural needle, loss or resistance syringe and spinal needle, were
missing from the valuation. One commenter indicated that a
radiographic-fluoroscopic room should be included for CPT codes 62310,
62311 and 62318; and a mobile C-Arm should be included for CPT code
62319. Another commenter requested the decreases in the PE RVUs be
phased in over a period of years.
Several commenters objected to the use of the interim final process
for valuing these codes, citing the lack of opportunity for public
comment and the lack of time to adequately prepare before the cuts to
reimbursement took effect. Some suggested a delay in implementation.
Lastly, several commenters requested refinement panel review of
these codes.
After analyzing the comments and considering valuation of these
codes, we believe that we need to reassess our valuation of these codes
and require additional information in order to do so. Our data show
that these epidural codes are frequently billed with imaging guidance.
For example, CPT code 62310 was billed with CPT code 77003
(Fluoroscopic guidance and localization of needle or catheter tip for
spine or paraspinous diagnostic or therapeutic injection procedures
(epidural or subarachnoid)) 79 percent of the time in the nonfacility
setting in CY 2013. CPT code 62319, which is the epidural injection
code that is least frequently billed with CPT code 77003 in the
nonfacility setting, was still billed with this guidance code 40
percent of the time. These codes were also frequently billed with image
guidance in the facility setting. CPT codes 62310 and 62311 were billed
with CPT code 77003, 79 percent and 74 percent of the time,
[[Page 40339]]
respectively in CY 2013. However, in the facility setting CPT codes
62318 and 62319 were much less frequently billed with CPT code 77003,
only 3 percent and 11 percent, respectively. In addition, these four
epidural injection codes are sometimes billed with other fluoroscopic
or imaging guidance codes. Based on the frequency with which these
codes are reported with fluoroscopic guidance codes, it appears that
fluoroscopic guidance is both typically used and typically reported
separately in conjunction with the epidural injection services.
As we considered the concerns raised regarding the CY 2014 payment
changes for the epidural injection procedures, we looked at the values
for other injection procedures. Other injection procedures, including
some recommended by commenters for use as a reference in valuing these
epidural injection codes, include the work and PEs of image guidance in
the injection code. For example, transforaminal injections, CPT codes
64479 (Injection(s), anesthetic agent and/or steroid, transforaminal
epidural, with imaging guidance (fluoroscopy or CT); cervical or
thoracic, single level), 64480 (Injection(s), anesthetic agent and/or
steroid, transforaminal epidural, with imaging guidance (fluoroscopy or
CT); cervical or thoracic, each additional level (List separately in
addition to code for primary procedure)), 64483 (Injection(s),
anesthetic agent and/or steroid, transforaminal epidural, with imaging
guidance (fluoroscopy or CT); lumbar or sacral, single level) and 64484
(Injection(s), anesthetic agent and/or steroid, transforaminal
epidural, with imaging guidance (fluoroscopy or CT); lumbar or sacral,
each additional level (List separately in addition to code for primary
procedure)) include the image guidance in the injection code.
Similarly, the paravertebral injections, CPT code 64490 (Injection(s),
diagnostic or therapeutic agent, paravertebral facet (zygapophyseal)
joint (or nerves innervating that joint) with image guidance
(fluoroscopy or CT), cervical or thoracic; single level), 64491
(Injection(s), diagnostic or therapeutic agent, paravertebral facet
(zygapophyseal) joint (or nerves innervating that joint) with image
guidance (fluoroscopy or CT), cervical or thoracic; second level (List
separately in addition to code for primary procedure)), 64492
(Injection(s), diagnostic or therapeutic agent, paravertebral facet
(zygapophyseal) joint (or nerves innervating that joint) with image
guidance (fluoroscopy or CT), cervical or thoracic; third and any
additional level(s) (List separately in addition to code for primary
procedure)), 64493 (Injection(s), diagnostic or therapeutic agent,
paravertebral facet (zygapophyseal) joint (or nerves innervating that
joint) with image guidance (fluoroscopy or CT), lumbar or sacral;
single level), 64494 (Injection(s), diagnostic or therapeutic agent,
paravertebral facet (zygapophyseal) joint (or nerves innervating that
joint) with image guidance (fluoroscopy or CT), lumbar or sacral;
second level (List separately in addition to code for the primary
procedure)) and 64495 (Injection(s), diagnostic or therapeutic agent,
paravertebral facet (zygapophyseal) joint (or nerves innervating that
joint) with image guidance (fluoroscopy or CT), lumbar or sacral; third
and any additional level(s)(List separately in addition to code for
primary procedure)) each include the image guidance bundled in the
injection CPT code.
Based upon our analysis of the Medicare claims data and comments
received on the CY 2014 final rule with comment period, it appears that
these codes are typically furnished with imaging guidance. Thus, we
believe it would be appropriate for the injection and imaging guidance
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 do not believe the epidural
injection codes can be appropriately valued without considering the
typical use of image guidance. We also believe this 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 believe more information is needed. Accordingly, we propose
to include CPT codes 62310, 62311, 62318 and 62319 on the potentially
misvalued code list so that we can obtain information to support their
valuation with the image guidance included. In the meantime, we are
proposing to revert to the CY 2013 input values for CPT codes 62310,
62311, 62318 and 62319 for CY 2015. Specifically, we will use the CY
2013 work RVUs, work times, and direct PE inputs to establish payment
rates for CY 2015. The work, PE, and MP RVUs for these codes are listed
in Addendum B and the time values for all CY 2015 codes are listed in
the file ``CY 2015 PFS Work Time,'' available on the CMS Web site under
downloads 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 direct PE inputs are displayed the
file ``CY 2015 PFS Direct PE Inputs,'' available on the CMS Web site
under downloads for the CY 2015 PFS proposed rule at http://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/PhysicianFeeSched/PFS-Federal-Regulation-Notices.html.
Because it is clear that the proposed PE inputs for the epidural
injection codes include items that are specifically related to image
guidance, such as the radiographic fluoroscopic room, we believe
separate reporting of the image guidance codes would overestimate the
resources used in furnishing the two services together. To avoid this
situation, we are also proposing to prohibit the billing of image
guidance codes in conjunction with these four epidural injection codes.
We believe our two-tiered proposal to utilize CY 2013 input values for
this code family, while prohibiting the separate billing of imaging
guidance codes in conjunction with epidural injection, would best
ensure that appropriate reimbursement continues to be made while we
gather additional information and consider the best way to value these
services.
With regard to comments about the time for responding to the
interim values, we would refer to section II.F of this proposed rule,
which discusses a proposal to make changes in the process used for
establishing revised values for codes such as these.
With regard to the request for refinement, we are denying this
request as the comments do not demonstrate that the requirements for
refinement were met. Moreover, since we are proposing different values
for these codes for CY 2015 (using CY 2013 inputs) there would be no
purpose for refinement as the public comment period for this proposed
rule will provide the opportunity for the public to share any relevant
information on our proposed values.
(3) Neurostimulator Implantation--CPT Codes 64553 and 64555
A stakeholder raised questions regarding whether CPT codes 64553
(Percutaneous implantation of neurostimulator electrode array; cranial
nerve) and 64555 (Percutaneous implantation of neurostimulator
electrode array; peripheral nerve (excludes sacral nerve)) included the
appropriate direct PE inputs when furnished in the nonfacility setting.
It appears that these inputs have not been evaluated recently and,
therefore, we are nominating these codes as potentially misvalued for
the purpose of
[[Page 40340]]
ascertaining whether or not there are nonfacility direct PE inputs that
are not included in the direct PE inputs that are typical supply costs
for these services.
(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 be
used for digital technology in response to special payment rules for
digital mammography included in the Medicare Benefit Improvements and
Protection Act of 2000.
As discussed in section II.A., 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
the typically used in imaging.
Our data confirms that the overwhelming majority of all mammography
is digital. As a result, we are proposing that the CPT codes 77055,
77056 and 77057 be used for reporting mammography to Medicare
regardless of whether film or digital technology is used, and to delete
the HCPCS G-codes G0202, G0204, and G0206. We are proposing, for CY
2015, to value the CPT codes using the values established for the
digital mammography G-codes since digital technology is now the typical
service. (See section II.A. of this proposed rule for more discussion
of this proposal.) In addition, since the G-codes values that we
propose to use for the CPT codes for CY 2015 have not been reviewed
since they were created in CY 2002, we are proposing to include CPT
codes 77055, 77056, and 77057 on the list of potentially misvalued
codes.
(5) Abdominal Aortic Aneurysm Ultrasound Screening--G0389
When Medicare began paying for abdominal aortic aneurysm (AAA)
ultrasound screening in CY 2007, we created HCPCS code G0389
(Ultrasound, B-scan and/or real time with image documentation; for
abdominal aortic aneurysm (AAA) screening), and 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, based on a RUC recommendation, we
proposed to replace the ultrasound room included as a direct PE input
for CPT code 76775 with a portable ultrasound unit. Since all the RVUs
(including the PE RVUs) for G0389 were crosswalked from CPT code 76775,
the proposed PE RVUs for G0389 in the CY 2014 proposed rule were
reduced significantly as a result of this change to the direct PE
inputs for 76775. However, we did not discuss the applicability of this
change to G0389 in the proposed rule's preamble 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 the corresponding PE RVUs for G0389 were also reduced.
Subsequent to the publication of the CY 2014 final rule, a
stakeholder suggested that the reduction in the RVUs for G0389 did not
accurately reflect the resources involved in furnishing the service and
asked that CMS consider using an alternative crosswalk. Specifically,
the stakeholder stated that the type of equipment typically used in
furnishing G0389 is different than that used for CPT code 76775, the
time involved in furnishing G0389 is greater than that of CPT code
76775, and the specialty that typically furnishes G0389 is different
than the one that typically furnishes CPT code 76775. The stakeholder
suggested an alternative crosswalk of CPT code 76705 (Ultrasound,
abdominal, real time with image documentation; limited (eg, single
organ, quadrant, follow-up)).
After considering the issue, we are proposing G0389 as a
potentially misvalued code and seeking recommendations regarding the
appropriate inputs that should be used to develop RVUs for this code.
We have not reviewed the inputs used to develop RVUs for this code
since it was established in CY 2007 and the RVUs were directly
crosswalked from 76705. Based on the issues raised by stakeholders, we
believe that we should value this code through our standard
methodologies, including the full PE RVU methodology. In order to do
so, we are proposing to include this code on our list of proposed
potentially misvalued codes and seek input from the public and other
stakeholders, including the RUC, regarding the appropriate work RVU,
time, and direct PE inputs that reflect the typical resources involved
in furnishing the service.
Until we receive the information needed to revalue this service, we
are proposing to maintain the work RVU for this code and revert to the
same PE RVUs we used for CY 2013, adjusted for budget neutrality. We
are proposing MP RVUs based on the five-year review update process as
described in section II.C of this proposed rule. We believe this
valuation will ameliorate the effect of the CY 2014 reduction in G0389
that resulted from reflection of the change in RVUs for the crosswalked
code while we assess the valuation of this code through our usual
methodologies. The proposed PE RVUs are contained in Addendum B
available on the CMS Web site under downloads for the CY 2015 PFS
proposed rule at http://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/PhysicianFeeSched/PFS-Federal-Regulation-Notices.html.
(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:
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. In considering these discussions and our review, we have
become aware that the
[[Page 40341]]
current coding structure may be confusing, especially since the number
of specimens associated with prostate biopsies is relatively
homogenous. For example, G0416 (10-20 specimens) represents the
overwhelming majority of all Medicare claims submitted for the four G-
codes. Therefore, in the interest of both establishing straightforward
coding and maintaining accurate payment, we believe it would be
appropriate to use only one code to report prostate biopsy pathology
services. Therefore, we propose 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 propose to revise G0416 for use to
report all prostate biopsy pathology services, regardless of the number
of specimens, because we believe this will eliminate the possible
confusion caused by the coding while maintaining payment accuracy.
Based on our review of medical literature and examination of
Medicare claims data, we believe that the typical number of specimens
evaluated for prostate biopsies is between 10 and 12. Since G0416 is
the code that currently is valued and used for between 10 and 12
specimens, we are proposing to use the existing values for G0416 for CY
2015.
In addition, we are proposing G0416 as a potentially misvalued code
for CY 2015. We seek public comment on the appropriate work RVUs, work
time, and direct PE inputs.
(7) Obesity Behavioral Group Counseling--GXXX2 and GXXX3
Under 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 has been 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 are creating two new HCPCS codes
for the reporting and payment of group behavioral counseling for
obesity. Specifically, we are creating 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). The
coverage requirements for these services would remain in place, as
described in the National Coverage Determination for Intensive
Behavioral Therapy for Obesity cited in this section of the proposed
rule. The practitioner furnishing these services would report the
relevant group code for each beneficiary participating in a group
therapy session.
We believe 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, which is a 15-minute code with
a work RVU of 0.45. Therefore, to develop proposed work RVUs for HCPCS
codes GXXX2 and GXXX3 we scaled the work RVU of HCPCS code G0447 to
reflect the differences in the codes in terms of the time period
covered by the code and the typical number of beneficiaries per
session. Adjusting the work RVU for the longer time of the group codes
results in a work RVU of 0.90 for a 30-minute session. Since the
services described by GXXX2 and GXXX3 will be billed per beneficiary
receiving the service, the work RVUs and work time that we are
proposing for these codes are based upon the typical number of
beneficiaries per session, 4 and 9, respectively. Accordingly, we are
proposing 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.
Using the same logic, we are proposing 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 described by
the new codes. The proposed direct PE inputs for these codes are
included in the CY 2015 proposed direct PE input database, available on
the CMS Web site under the downloads for the CY 2015 PFS proposed rule
at http://www.cms.gov/PhysicianFeeSched/. We are also proposing 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 request public comment on these proposed
values for HCPCS codes GXXX2 and GXXX3.
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 provided 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
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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.
These unique characteristics have contributed to the significant
and numerous concerns that have been raised regarding the accuracy of
payment for global codes--especially those that include 10- and 90-day
post-operative periods. In the following paragraphs, we address a
series of concerns regarding these codes, including: the fundamental
difficulties in establishing appropriate relative values for these
packages, the potential inaccuracies in the current information used to
price these services, the limitations on appropriate pricing in the
future, the potential for these 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.
Independently, concerns such as these could be seen as issues that
arise when developing many different payment mechanisms, for example:
making fee-for-service payment rates, making single payments for
multiple services, or paying practitioners 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 these multi-layered
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 the 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
other PFS services 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 an
annual 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 that ten post-operative visits is typical, but
practitioners reporting the code 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. Although such a mechanism is common in other bundled payment
systems, there is no such mechanism under the PFS. 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.
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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 services 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 provided 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 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. Although such information would be
available for developing payment rates for bundled services through
other Medicare payment systems, practitioners paid through the PFS do
not report such data.
[[Page 40344]]
(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 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
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 proposed rule, 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,
[[Page 40345]]
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 Transition 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 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 are proposing to retain
global bundles for surgical services, but to refine bundles by
transitioning 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 transitioning 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 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 seek 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 seek 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 seek 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 seek 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 are
also seeking 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 conducting 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
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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 seek 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 essential to ensuring work
RVU relativity across these services. We also believe that these data
will be necessary 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 are 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, 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.
While we believe these are plausible options for the revaluation of
these services, we believe there may be others. Therefore, we seek
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 seek 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 are
proposing to transition 10-day global periods in 2017 and 90-day global
periods in 2018, we seek comment on whether we should consider
implementing the transition more or less quickly and over one or
several years. We also seek comment regarding the appropriate valuation
of new, revised, or potentially misvalued 10- or 90-day global codes
before implementation of this proposal.
5. Improving the Valuation of the Global Package
In the CY 2013 proposed rule, we sought comments on methods of
obtaining accurate and current data on E/M services furnished as part
of a global surgical package. In addition to receiving the broader
comments on measuring post-operative work, we also received a comment
from the RUC saying that the hospital inpatient and discharge day
management services included in the global period for many surgical
procedures were inadvertently removed from the time file in 2007. With
its comment letter, the RUC sent us a data file with updated times for
these post-operative visits for some services that displayed zero
hospital inpatient or discharge day visits in the CMS time file. After
extensive review, we concluded that the data were deleted from the time
file due to an inadvertent error as noted by the RUC. Therefore, during
CY 2014 PFS rulemaking we finalized a proposal to replace the missing
postoperative hospital inpatient and discharge day visits for the more
than 100 codes that were identified by the RUC.
Since then, the AMA has identified additional codes with data in
the work time file that reflects a similar error. Since we believe
these global surgery codes are missing postoperative hospital inpatient
and discharge day visits due to an inadvertent error, we are proposing
to include a corrected number of visits for the codes displayed in
Table 11. This proposal would also alter the total time associated with
the codes in the work time file.
[[Page 40347]]
TABLE 11--Proposed Work Time Changes in Selected Global Surgical Package Visits
--------------------------------------------------------------------------------------------------------------------------------------------------------
Visits included in Global Package
CPT code Short descriptor ------------------------------------------------------------------------------ CY 2014 CY 2015
99231 99232 99233 99238 99291 99292 time time
--------------------------------------------------------------------------------------------------------------------------------------------------------
19367................. Breast reconstruction... 3.00 ........... ........... 1.00 ........... ........... 552.00 590.00
20802................. Replantation arm 6.00 ........... ........... 1.00 ........... ........... 1047.00 1041.00
complete.
20805................. Replant forearm complete 6.00 ........... ........... 1.00 ........... ........... 1017.00 1012.00
20808................. Replantation hand 5.00 ........... ........... 1.00 ........... ........... 1177.00 1112.00
complete.
20972................. Bone/skin graft 5.00 ........... ........... 1.00 ........... ........... 918.00 898.00
metatarsal.
21137................. Reduction of forehead... ........... ........... ........... 1.00 ........... ........... 272.00 310.00
21138................. Reduction of forehead... ........... ........... ........... 1.00 ........... ........... 362.00 400.00
21150................. Lefort ii anterior 1.00 ........... ........... 1.00 1.00 ........... 542.00 623.00
intrusion.
21159................. Lefort iii w/fhdw/o 3.00 ........... ........... 1.00 2.00 ........... 784.00 986.00
lefort i.
21160................. Lefort iii w/fhd w/ ........... 2.50 ........... 1.00 2.50 ........... 844.00 1121.00
lefort i.
21172................. Reconstruct orbit/ ........... 1.50 ........... 1.00 1.50 ........... 474.00 641.00
forehead.
21175................. Reconstruct orbit/ ........... 1.00 ........... 1.00 2.00 ........... 767.00 731.00
forehead.
21179................. Reconstruct entire ........... ........... ........... 1.00 2.00 ........... 412.00 590.00
forehead.
21180................. Reconstruct entire ........... ........... ........... 1.00 2.00 ........... 492.00 670.00
forehead.
21181................. Contour cranial bone 1.00 ........... ........... 1.00 ........... ........... 338.00 396.00
lesion.
21182................. Reconstruct cranial bone ........... 1.00 ........... 1.00 2.00 ........... 856.00 801.00
21183................. Reconstruct cranial bone ........... 2.00 ........... 1.00 2.00 ........... 669.00 891.00
21184................. Reconstruct cranial bone ........... 2.00 ........... 1.00 2.00 ........... 774.00 996.00
22102................. Remove part lumbar 3.00 ........... ........... 1.00 ........... ........... 392.00 387.00
vertebra.
22310................. Closed tx vert fx w/o 3.50 ........... ........... 1.00 ........... ........... 167.00 236.00
manj.
28122................. Partial removal of foot ........... ........... ........... 1.00 ........... ........... 230.00 249.00
bone.
33470................. Revision of pulmonary 1.50 ........... ........... 1.00 3.50 ........... 890.00 769.00
valve.
33471................. Valvotomy pulmonary 4.00 ........... ........... 1.00 1.00 ........... 603.00 572.00
valve.
33476................. Revision of heart ........... ........... ........... 1.00 5.00 ........... 725.00 859.00
chamber.
33478................. Revision of heart ........... ........... ........... 1.00 5.00 ........... 740.00 882.00
chamber.
33610................. Repair by enlargement... 7.00 ........... ........... 1.00 ........... ........... 770.00 648.00
33720................. Repair of heart defect.. ........... ........... ........... 1.00 4.00 ........... 633.00 770.00
33737................. Revision of heart 2.00 ........... ........... 1.00 3.00 ........... 603.00 706.00
chamber.
33755................. Major vessel shunt...... 1.50 ........... ........... 1.00 3.50 ........... 680.00 750.00
33762................. Major vessel shunt...... 1.50 ........... ........... 1.00 3.50 ........... 740.00 755.00
33766................. Major vessel shunt...... 1.50 ........... ........... 1.00 3.50 ........... 740.00 756.00
33775................. Repair great vessels 0.50 ........... ........... 1.00 6.50 ........... 860.00 1043.00
defect.
33776................. Repair great vessels 1.50 ........... ........... 1.00 6.50 ........... 950.00 1096.00
defect.
33777................. Repair great vessels 3.50 ........... ........... 1.00 4.50 ........... 950.00 993.00
defect.
33813................. Repair septal defect.... 1.00 ........... ........... 1.00 3.00 ........... 603.00 664.00
33814................. Repair septal defect.... ........... ........... ........... 1.00 5.00 ........... 710.00 838.00
33822................. Revise major vessel..... ........... ........... ........... 1.00 2.00 ........... 430.00 463.00
50360................. Transplantation of 1.00 2.00 2.00 1.00 ........... ........... 664.00 774.00
kidney.
61556................. Incise skull/sutures.... 3.00 3.00 1.00 1.00 ........... ........... 749.00 692.00
61558................. Excision of skull/ 5.00 ........... ........... 1.00 ........... ........... 669.00 661.00
sutures.
61559................. Excision of skull/ 4.00 ........... ........... 1.00 ........... ........... 662.00 665.00
sutures.
61563................. Excision of skull tumor. 1.00 2.00 1.00 1.00 ........... ........... 762.00 656.00
61564................. Excision of skull tumor. 4.00 ........... ........... 1.00 ........... ........... 629.00 623.00
61580................. Craniofacial approach ........... 3.00 4.00 1.00 1.00 ........... 1313.30 1078.30
skull.
61581................. Craniofacial approach 1.00 1.00 5.00 1.00 1.00 ........... 1419.40 1214.40
skull.
61582................. Craniofacial approach 4.00 3.00 1.00 1.00 1.00 ........... 1185.30 1010.30
skull.
61583................. Craniofacial approach 8.00 ........... 1.00 1.00 1.00 ........... 1100.40 906.40
skull.
61584................. Orbitocranial approach/ 2.00 3.00 2.00 1.00 1.00 ........... 1066.40 842.40
skull.
61585................. Orbitocranial approach/ 1.00 3.00 3.00 1.00 2.00 ........... 1377.70 1101.70
skull.
61590................. Infratemporal approach/ 1.00 ........... 7.00 1.00 2.00 ........... 1732.40 1418.40
skull.
61591................. Infratemporal approach/ 3.00 4.00 ........... 1.00 2.00 ........... 1478.85 1254.85
skull.
61592................. Orbitocranial approach/ 1.00 3.00 2.00 1.00 2.00 ........... 1256.80 1002.80
skull.
61595................. Transtemporal approach/ ........... 3.00 4.00 1.00 1.00 ........... 1312.80 1077.80
skull.
[[Page 40348]]
61596................. Transcochlear approach/ 1.00 4.00 3.00 1.00 1.00 ........... 1442.30 1188.30
skull.
61597................. Transcondylar approach/ 5.00 2.00 1.00 1.00 2.00 ........... 1284.40 1041.40
skull.
61598................. Transpetrosal approach/ 2.00 3.00 1.00 1.00 2.00 ........... 1253.10 1048.10
skull.
61600................. Resect/excise cranial ........... ........... 6.00 1.00 1.00 ........... 1328.40 1101.40
lesion.
61601................. Resect/excise cranial 2.00 2.00 2.00 1.00 2.00 ........... 1078.90 854.90
lesion.
61605................. Resect/excise cranial 3.00 2.00 1.00 1.00 2.00 ........... 1238.60 1052.60
lesion.
61606................. Resect/excise cranial 3.00 3.00 1.00 1.00 2.00 ........... 1161.90 926.90
lesion.
61607................. Resect/excise cranial ........... 1.00 6.00 1.00 2.00 ........... 1526.20 1201.20
lesion.
61608................. Resect/excise cranial 3.00 3.00 2.00 1.00 2.00 ........... 1326.00 1042.00
lesion.
61613................. Remove aneurysm sinus... 1.00 ........... 6.00 1.00 2.00 ........... 1416.00 1102.00
61615................. Resect/excise lesion 2.00 4.00 2.00 1.00 1.00 ........... 1327.20 1092.20
skull.
61616................. Resect/excise lesion 5.00 2.00 1.00 1.00 2.00 ........... 1329.80 1116.80
skull.
61618................. Repair dura............. ........... 1.00 2.00 1.00 ........... ........... 647.10 573.10
61619................. Repair dura............. 1.00 2.00 1.00 1.00 ........... ........... 683.60 587.60
62115................. Reduction of skull 4.50 ........... ........... 1.00 ........... ........... 672.00 678.00
defect.
62116................. Reduction of skull 1.00 2.00 1.00 1.00 ........... ........... 737.00 616.00
defect.
62117................. Reduction of skull ........... 2.00 2.00 1.00 ........... ........... 854.00 714.00
defect.
62120................. Repair skull cavity 3.00 ........... ........... 1.00 ........... ........... 512.00 523.00
lesion.
--------------------------------------------------------------------------------------------------------------------------------------------------------
[[Page 40349]]
6. 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.
It appears that practice patterns for endoscopic procedures are
changing, and anesthesia is increasingly being separately reported for
these procedures. For example, one study shows 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 shows that
a similar pattern is occurring in the Medicare program. We find 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 shows
that this rate is as high as 80 percent.
Our data clearly indicate that moderate sedation is no longer
typical for all of the procedures listed in CPT's Appendix G, and, in
fact, the data suggest that the percent of cases in which it is used is
declining. For many of these procedures in Appendix G, moderate
sedation continues to be furnished. The trend away from the use of
moderate sedation toward a separately billed anesthesia service is not
universal. It differs by the class of procedures, sometimes at the
procedure code level, and is one that continues to evolve over time.
Due to the changing nature of medical practice in this area, we are
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 are seeking public comment on approaches to address the
appropriate valuation of these services. Specifically, we are
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 request
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 note 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. In the CY 2015 PFS
final rule with comment period, we will address these interim final
values, and we anticipate establishing CY 2015 inputs for the lower
gastrointestinal procedures, many of which are also listed in Appendix
G. It is our expectation that we will not 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 this proposed
rule on the overall valuation of Appendix G codes.
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
a. General Discussion
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 parallels the process used in the CY
2010 update. The calculation requires 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,
the MP premium information must be weighted geographically and by
specialty. Accordingly, the proposed MP RVUs are 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 MP premium data primarily from state departments of insurance.
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
[[Page 40350]]
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). Given that the national
average premium amount for registered dietitians, physician assistants
and optometry is below the national average premium amount for allergy
and immunology, we crosswalked these specialties to allergy and
immunology, the specialty with the lowest premiums for which we had
sufficient and reliable data.
For the proposed CY 2015 MP RVU update, sufficient and reliable
premium data were available for 41 specialty types, which we used to
develop specialty-specific malpractice risk factors. (See Table 13 for
a list of these specialties.)
For specialties with insufficient or unreliable premium data, we
assigned the premium amounts of a similar specialty type. These
specialties and the specialty data that we propose to use are shown in
Table 12.
Table 12--Crosswalk of Specialties to Similar Specialties
----------------------------------------------------------------------------------------------------------------
Crosswalk
Specialty code Medicare specialty name specialty Crosswalk specialty
code
----------------------------------------------------------------------------------------------------------------
09.................. Interventional Pain 05 Anesthesiology.
Management.
12.................. Osteopathic 03 Allergy Immunology.
Manipulative Medicine.
15.................. Speech Language 03 Allergy Immunology.
Pathology.
17.................. Hospice and Palliative 03 Allergy Immunology.
Care.
19.................. Oral Surgery (dental 24 Plastic and Reconstructive Surgery.
only).
21.................. Cardiac 06 Cardiology.
Electrophysiology.
23.................. Sports Medicine........ 01 General Practice.
27.................. Geriatric Psychiatry... 26 Psychiatry.
32.................. Anesthesiologist 05 Anesthesiology.
Assistant.
35.................. Chiropractic........... 03 Allergy Immunology.
41.................. Optometry.............. 03 Allergy Immunology.
42.................. Certified Nurse Midwife 16 Obstetrics Gynecology.
43.................. Certified Registered 05 Anesthesiology.
Nurse Anesthetist.
50.................. Nurse Practitioner..... 01 General Practice.
60.................. Public Health or 03 Allergy Immunology.
Welfare Agency.
62.................. Psychologist........... 03 Allergy Immunology.
64.................. Audiologist............ 03 Allergy Immunology.
65.................. Physical Therapist..... 03 Allergy Immunology.
67.................. Occupational Therapist. 03 Allergy Immunology.
68.................. Clinical Psychologist.. 03 Allergy Immunology.
71.................. Registered Dietitian/ 03 Allergy Immunology.
Nutrition Professional.
72.................. Pain Management........ 05 Anesthesiology.
76.................. Peripheral Vascular 77 Vascular Surgery.
Disease.
79.................. Addiction Medicine..... 03 Allergy Immunology.
80.................. Licensed Clinical 03 Allergy Immunology.
Social Worker.
83.................. Hematology/Oncology.... 90 Medical Oncology.
85.................. Maxillofacial Surgery.. 24 Plastic and Reconstructive Surgery.
86.................. Neuropsychiatry........ 26 Psychiatry.
89.................. Certified Clinical 01 General Practice.
Nurse Specialist.
91.................. Surgical Oncology...... 02 General Surgery.
94.................. Interventional 30 Diagnostic Radiology.
Radiology.
97.................. Physician Assistant.... 03 Allergy Immunology.
98.................. Gynecological/Oncology. 16 Obstetrics Gynecology.
99.................. Unknown Physician 01 General Practice.
Specialty.
C0.................. Sleep Medicine......... 01 General Practice.
----------------------------------------------------------------------------------------------------------------
b. Steps for Calculating Proposed Malpractice RVUs
Calculation of the proposed MP RVUs conceptually follows the
specialty-weighted approach used in the CY 2010 final rule with comment
period (74 FR 61758). 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. The steps for calculating the proposed MP
RVUs are described below.
Step (1): Compute a preliminary national average premium for each
specialty.
Insurance rating area MP premiums for each specialty are mapped to
the
[[Page 40351]]
county level. The specialty premium for each county is then multiplied
by the total county RVUs for that specialty (from the Medicare claims
data for CY 2013). The product of the MP premiums and total county RVUs
is then summed across all counties for each specialty and then divided
by total national RVUs for the specialty. This calculation is then
divided by the average MP GPCI across all counties for each specialty
to yield a normalized national average premium for each specialty. The
specialty premiums are normalized for geographic variation so that the
locality cost differences (as reflected by the GPCIs) would not be
counted twice. Without the geographic variation adjustment, the cost
differences among fee schedule areas would be reflected once under the
methodology used to calculate the MP RVUs and again when computing the
service specific payment amount for a given fee schedule area.
Step (2): Determine which premium class(es) to use within each
specialty.
Some specialties had premium rates that differed for surgery,
surgery with obstetrics, and non-surgery. To account for the presence
of different classes in the MP premium data and the task of mapping
these premiums to procedures, we calculated distinct risk factors for
surgical, surgical with obstetrics, and nonsurgical procedures.
However, the availability of data by surgery and nonsurgery varied
across specialties. Consistent with the CY 2010 MP RVU update, because
no single approach accurately addressed the variability in premium
classes among specialties, we employed several methods for calculating
average premiums by specialty. These methods are discussed below.
(a) Substantial Data for Each Class: For 13 out of 41 specialties,
we determined that there was sufficient data for surgery and nonsurgery
premiums, as well as sufficient differences in rates between classes.
These specialties are listed in Table 13. Therefore, we calculated a
national average surgical premium and nonsurgical premium.
(b) Major Surgery Dominates: For 9 surgical specialties, rate
filings that included nonsurgical premiums were relatively rare. For
most of these surgical specialties, the rate filings did not include an
``unspecified'' premium. When it did, the unspecified premium was lower
than the major surgery rate. For these surgical specialties, we
calculated only a surgical premium and used the premium for major
surgery for all procedures furnished by this specialty.
(c) Unspecified Dominates: Many MP rate filings did not include
surgery or nonsurgery classes for some specialties; we refer to these
instances as unspecified MP rates. For 7 specialty types (listed in
Table 13), we selected the unspecified premium as the premium
information to use for the specialty. For these specialties, at least
35 states (and as many as 48 states) had MP premium amounts that were
not identified as surgery or nonsurgery in rate filings for the
specialty.
(d) Blend All Available: For the remaining specialties, there was
wide variation across the rate filings in terms of whether or not
premium classes were reported and which categories were reported.
Because there was no clear strategy for these remaining specialties, we
blended the available rate information into one general premium rate.
For these specialties, we developed a weighted average ``blended''
premium at the national level, according to the percentage of work RVUs
correlated with the premium classes within each specialty. For example,
the surgical premiums for a given specialty were weighted by that
specialty's work RVUs for surgical services; the nonsurgical premiums
were weighted by the work RVUs for nonsurgical services and the
unspecified premiums were weighted by all work RVUs for the specialty
type.
The four methods for calculating premiums by specialty type are
summarized in Table 13. (See Table 14: ``Risk Factors by Specialty
Type'' for the specialty names associated with the specialty codes
listed in Table 13.)
Table 13--Proposed Premium Calculation Approach by Specialty Type
----------------------------------------------------------------------------------------------------------------
Method Medicare specialty codes
----------------------------------------------------------------------------------------------------------------
(a) Substantial Data for Each 01, 04, 06, 07, 08 (non[dash]OB), 10, 13, 18, 34, 38, 39, 46, 93
Class (13).
(b) Major Surgery Dominates (9).. 02, 14, 20, 24, 28, 33, 40, 77, 78
(c) Unspecified Dominates (7).... 03, 05, 16 (non[dash]OB), 25, 26, 36, 81
(d) Blend All Available (12)..... 11, 22, 29, 30, 37, 44, 48, 66, 82, 84, 90, 92
----------------------------------------------------------------------------------------------------------------
(e) Premium Calculation for Neurosurgery: For neurosurgery, premium
data were available from 24 states; therefore, we did not have
sufficient data to calculate a national average premium amount for
neurosurgery. As explained above, we typically crosswalk a specialty
with insufficient premium data (less than 35 states) to a similar
specialty for which we have sufficient data, conceptually or by
reported premiums. We considered cross-walking neurosurgery directly to
the national average premium for a similar specialty that had
sufficient data such as neurology or to another surgical specialty. We
did not crosswalk neurosurgery directly to another surgical specialty
because no other surgical specialty had similar premium values reported
in the rate filings. For instance, the surgical premium for
neurosurgery is $123,400 while the surgical premium for the next
highest surgical specialty (surgical oncology) is $59,808. We also did
not crosswalk neurosurgery directly to neurology because the rate
filings for neurology include substantial premium data for both surgery
and non-surgery while the rate filings for neurosurgery are dominated
by major surgery premiums. We do not believe that it would be
appropriate to assign non-surgical premiums reported for neurology to
neurosurgery.
However, the national average surgical premium amount for neurology
($96,970) and the surgical premium amount for neurosurgery are similar.
Therefore, we blended the surgical premium data for neurology and
neurosurgery instead of crosswalking directly to neurology or directly
to another surgical specialty. In other words, we calculated a combined
national average surgical premium for neurosurgery and neurology. The
reasons as to why we are proposing to blend surgical premiums for
neurology and neurosurgery, instead of crosswalking neurosurgery
directly to neurology or directly to another surgical specialty, are
further explained below.
The rate filings for neurosurgery are dominated by major
surgery premiums.
The rate filings identifying nonsurgical premiums for
neurosurgery are sparse.
The rate filings for neurology include substantial premium
data for both surgery and nonsurgery.
[[Page 40352]]
Neurology is similar to neurosurgery both conceptually and
by reported surgical premium amounts.
Surgical premiums from the rate filings for other surgical
specialties are lower than for neurosurgery and neurology.
Given that the rate filings for neurosurgery are dominated by major
surgical premiums and that surgical premium amounts for neurology are
similar to neurosurgery, we believe that combining the surgical premium
data for neurosurgery and neurology is a better representation of the
MP premium amounts paid by neurosurgeons than crosswalking neurosurgery
directly to neurology or to another surgical specialty.
Step (3): Calculate a risk factor for each specialty.
The relative differences in national average premiums between
specialties are expressed in our methodology as a specialty risk
factor. These risk factors are an index calculated by dividing the
national average premium for each specialty by the national average
premium for the specialty with the lowest premiums for which we had
sufficient and reliable data, allergy and immunology. For specialties
with sufficient surgical and nonsurgical premium data, we calculated
both a surgical and nonsurgical risk factor. For specialties with rate
filings that distinguished surgical premiums with obstetrics from those
without, we calculated a separate surgical with obstetrics risk factor.
For all other specialties we calculated a single risk factor and
applied the specialty risk factor to both surgery and nonsurgery
services.
We note that for determining the risk factor for suppliers of TC-
only services, we were not able to obtain more recent premium data than
what was used for the CY 2010 update. Therefore, we updated the premium
data for IDTFs that we used in the CY 2010 update. These data were
obtained from a survey conducted by the Radiology Business Management
Association (RBMA) in 2009. We updated the RBMA survey data by the
change in non-surgical premiums for all specialty types since the
previous MP RVU update and calculated an updated TC specialty risk
factor. We applied the updated TC specialty risk factor to suppliers of
TC-only services. Table 14 shows the risk factors by specialty type.
Table 14--Risk Factors by Specialty Type
------------------------------------------------------------------------
Medicare Non-surgical Surgical risk
Specialty code specialty name risk factor factor
------------------------------------------------------------------------
01................ General Practice 1.83 4.11
02................ General Surgery. ................ 7.30
03................ Allergy 1.00 1.00
Immunology.
04................ Otolaryngology.. 1.95 4.47
05................ Anesthesiology.. 2.42 2.42
06................ Cardiology...... 2.11 7.10
07................ Dermatology..... 1.25 4.11
08................ Family Practice. 1.77 4.18
08 OB............. Family Practice ................ 3.95
w/OB.
09................ Interventional 2.42 2.42
Pain Management.
10................ Gastroenterology 2.16 4.45
11................ Internal 2.07 2.07
Medicine.
12................ Osteopathic 1.00 1.00
Manipulative
Medicine.
13................ Neurology....... 2.59 13.04
14................ Neurosurgery.... ................ 13.04
15................ Speech Language 1.00 1.00
Pathology.
16................ Obstetrics 3.80 3.80
Gynecology.
16 OB............. Obstetrics ................ 8.05
Gynecology w/OB.
17................ Hospice and 1.00 1.00
Palliative Care.
18................ Ophthalmology... 1.22 2.21
19................ Oral Surgery ................ 5.11
(dental only).
20................ Orthopedic ................ 6.38
Surgery.
21................ Cardiac 2.11 7.10
Electrophysiolo
gy.
22................ Pathology....... 1.79 1.79
23................ Sports Medicine. 1.83 4.11
24................ Plastic and ................ 5.11
Reconstructive
Surgery.
25................ Physical 1.39 1.39
Medicine and
Rehabilitation.
26................ Psychiatry...... 1.13 1.13
27................ Geriatric 1.13 1.13
Psychiatry.
28................ Colorectal ................ 4.08
Surgery
(formerly
Proctology).
29................ Pulmonary 2.33 2.33
Disease.
30................ Diagnostic 2.99 2.99
Radiology.
32................ Anesthesiologist 2.42 2.42
Assistant.
33................ Thoracic Surgery ................ 7.27
34................ Urology......... 1.61 3.39
35................ Chiropractic.... 1.00 1.00
36................ Nuclear Medicine 1.41 1.41
37................ Pediatric 1.82 1.82
Medicine.
38................ Geriatric 1.78 4.83
Medicine.
39................ Nephrology...... 1.71 4.27
40................ Hand Surgery.... ................ 4.71
41................ Optometry....... 1.00 1.00
42................ Certified Nurse 3.80 3.80
Midwife.
42 OB............. Certified Nurse ................ 8.05
Midwife w/OB.
43................ Certified 2.42 2.42
Registered
Nurse
Anesthetist
(CRNA).
44................ Infectious 2.41 2.41
Disease.
45................ Mammography 0.90 ................
Screening
Center.
[[Page 40353]]
46................ Endocrinology... 1.65 4.23
47................ Independent 0.90 ................
Diagnostic
Testing
Facility.
48................ Podiatry........ 2.22 2.22
50................ Nurse 1.83 4.11
Practitioner.
60................ Public Health or 1.00 1.00
Welfare Agency.
62................ Psychologist.... 1.00 1.00
63................ Portable X-Ray 0.90 ................
Supplier.
64................ Audiologist..... 1.00 1.00
65................ Physical 1.00 1.00
Therapist.
66................ Rheumatology.... 1.77 1.77
67................ Occupational 1.00 1.00
Therapist.
68................ Clinical 1.00 1.00
Psychologist.
69................ Clinical 0.90 ................
Laboratory.
71................ Registered 1.00 1.00
Dietitian/
Nutrition
Professional.
72................ Pain Management. 2.42 2.42
74................ Radiation 0.90 ................
Therapy Center.
75................ Slide 0.90 ................
Preparation
Facilities.
76................ Peripheral ................ 7.19
Vascular
Disease.
77................ Vascular Surgery ................ 7.19
78................ Cardiac Surgery. ................ 7.23
79................ Addiction 1.00 1.00
Medicine.
80................ Licensed 1.00 1.00
Clinical Social
Worker.
81................ Critical Care 2.83 2.83
(Intensivists).
82................ Hematology...... 1.81 1.81
83................ Hematology/ 1.89 1.89
Oncology.
84................ Preventive 1.44 1.44
Medicine.
85................ Maxillofacial ................ 5.11
Surgery.
86................ Neuropsychiatry. 1.13 1.13
89................ Certified 1.83 4.11
Clinical Nurse
Specialist.
90................ Medical Oncology 1.89 1.89
91................ Surgical ................ 7.30
Oncology.
92................ Radiation 2.36 2.36
Oncology.
93................ Emergency 3.29 5.17
Medicine.
94................ Interventional 2.99 2.99
Radiology.
97................ Physician 1.00 1.00
Assistant.
98................ Gynecological/ 3.80 3.80
Oncology.
98 OB............. Gynecological/ ................ 8.05
Oncology w/OB.
99................ Unknown 1.83 4.11
Physician
Specialty.
C0................ Sleep Medicine.. 1.83 4.11
TC................ IDTFs (TC only). 0.90 ................
------------------------------------------------------------------------
(a) Invasive Cardiology: Consistent with the previous MP RVU
update, we continued to classify invasive cardiology services (cardiac
catheterizations and angioplasties) that are outside of the surgical
HCPCS code range as surgery for purposes of assigning specialty-
specific risk factors. We note that since the previous MP RVU update
some invasive cardiology service HCPCS codes have been revised.
Therefore, we modified the list of invasive cardiology services outside
the surgical HCPCS code range that are to be considered surgery in
order to correspond conceptually to the list of service codes used for
the CY 2010 MP RVU update. We continue to believe that the malpractice
risk for cardiac catheterization and angioplasty services are more
similar to the risk of surgical procedures than most nonsurgical
service codes. As such, we applied the higher cardiology surgical risk
factor to cardiology catheterization and angioplasty services.
For the CY 2015 MP RVU update, we examined the possibility of
classifying injection procedures used in conjunction with cardiac
catheterization as surgery (for purposes of assigning service specific
risk factors). After careful consideration, we believe that injection
procedures, when furnished in conjunction with cardiac catheterization,
are more akin to the malpractice risk of surgical procedures than most
non-surgical services. Therefore we applied the surgical risk factor to
injection procedures used in conjunction with cardiac catheterization.
Table 15 shows the invasive cardiology services and injection services
furnished in conjunction with cardiac catheterization to be considered
as surgery for purposes of assigning specialty-specific risk factors.
Table 15--Services Outside of Surgical HCPCS Code Range Considered
Surgery
------------------------------------------------------------------------
HCPCS code Short descriptor
------------------------------------------------------------------------
92920............................. Prq cardiac angioplast 1 art.
92921............................. Prq cardiac angio addl art.
92924............................. Prq card angio/athrect 1 art.
92925............................. Prq card angio/athrect addl.
92928............................. Prq card stent w/angio 1 vsl.
92929............................. Prq card stent w/angio addl.
92933............................. Prq card stent/ath/angio.
92934............................. Prq card stent/ath/angio.
92937............................. Prq revasc byp graft 1 vsl.
92938............................. Prq revasc byp graft addl.
92941............................. Prq card revasc mi 1 vsl.
92943............................. Prq card revasc chronic 1vsl.
92944............................. Prq card revasc chronic addl.
92970............................. Cardioassist internal.
92971............................. Cardioassist external.
92973............................. Prq coronary mech thrombect.
92974............................. Cath place cardio brachytx.
92975............................. Dissolve clot heart vessel.
92977............................. Dissolve clot heart vessel.
92978............................. Intravasc us heart add-on.
[[Page 40354]]
92979............................. Intravasc us heart add-on.
93451............................. Right heart cath.
93452............................. Left hrt cath w/ventrclgrphy.
93453............................. R&l hrt cath w/ventriclgrphy.
93454............................. Coronary artery angio s&i.
93455............................. Coronary art/grft angio s&i.
93456............................. R hrt coronary artery angio.
93457............................. R hrt art/grft angio.
93458............................. L hrt artery/ventricle angio.
93459............................. L hrt art/grft angio.
93460............................. R&l hrt art/ventricle angio.
93461............................. R&l hrt art/ventricle angio.
93462............................. L hrt cath trnsptl puncture.
93503............................. Insert/place heart catheter.
93505............................. Biopsy of heart lining.
93530............................. Rt heart cath congenital.
93531............................. R & l heart cath congenital.
93532............................. R & l heart cath congenital.
93533............................. R & l heart cath congenital.
93580............................. Transcath closure of asd.
93581............................. Transcath closure of vsd.
93582............................. Perq transcath closure pda.
93583............................. Perq transcath septal reduxn.
93600............................. Bundle of his recording.
93602............................. Intra-atrial recording.
93603............................. Right ventricular recording.
93609............................. Map tachycardia add-on.
93610............................. Intra-atrial pacing.
93612............................. Intraventricular pacing.
93613............................. Electrophys map 3d add-on.
93618............................. Heart rhythm pacing.
93619............................. Electrophysiology evaluation.
93620............................. Electrophysiology evaluation.
93621............................. Electrophysiology evaluation.
93622............................. Electrophysiology evaluation.
93623............................. Stimulation pacing heart.
93624............................. Electrophysiologic study.
93631............................. Heart pacing mapping.
93640............................. Evaluation heart device.
93641............................. Electrophysiology evaluation.
93642............................. Electrophysiology evaluation.
93650............................. Ablate heart dysrhythm focus.
93653............................. Ep & ablate supravent arrhyt.
93654............................. Ep & ablate ventric tachy.
93655............................. Ablate arrhythmia add on.
93656............................. Tx atrial fib pulm vein isol.
93657............................. Tx l/r atrial fib addl.
93563............................. Inject congenital card cath.
93564............................. Inject hrt congntl art/grft.
93565............................. Inject l ventr/atrial angio.
93566............................. Inject r ventr/atrial angio.
93567............................. Inject suprvlv aortography.
93568............................. Inject pulm art hrt cath.
93571............................. Heart flow reserve measure.
93572............................. Heart flow reserve measure.
------------------------------------------------------------------------
Step (4): Calculate malpractice RVUs for each HCPCS code.
Resource-based MP RVUs were calculated for each HCPCS code that has
work or PE RVUs. The first step was to identify the percentage of
services furnished by each specialty for each respective HCPCS code.
This percentage was then multiplied by each respective specialty's risk
factor as calculated in Step 3. The products for all specialties for
the HCPCS code were then added together, yielding a specialty-weighted
service specific risk factor reflecting the weighted malpractice costs
across all specialties furnishing that procedure. The service specific
risk factor was multiplied by the greater of the work RVU or PE
clinical labor index for that service to reflect differences in the
complexity and risk-of-service between services.
(a) Low volume service codes: As discussed previously in this
section, service-specific MP RVUs are determined based on the weighted
average risk factor(s) of the specialties that furnish the service. For
rarely-billed Medicare services (that is, when CY 2013 claims data
reflected allowed services of less than 100), we used only the risk
factor of the dominant specialty as reflected in our claims data.
Approximately 2,000 services met the criteria for ``low volume.'' The
dominant specialty for each ``low volume'' service was also determined
from CY 2013 Medicare claims data. We continue to believe that a
balanced approach between including all of the specialties in our
claims data and the application of the dominant specialty for each low
volume service is the most appropriate approach to the development of
malpractice RVUs.
Step (5): Rescale for budget neutrality.
The statute requires that changes to fee schedule RVUs must be
budget neutral. The current resource-based MP RVUs and the proposed
resource-based MP RVUs were constructed using different malpractice
premium data. Thus, the last step is to adjust for budget neutrality by
rescaling the proposed MP RVUs so that the total proposed resource-
based MP RVUs equal the total current resource-based MP RVUs.
The proposed resource-based MP RVUs are shown in Addendum B, which
is available on the CMS Web site under the supporting documents section
of the CY 2015 PFS rule at http://www.cms.gov/PhysicianFeeSched/. These
values have been adjusted for budget neutrality on the basis of the
most recent 2013 utilization data available. We will make a final
budget neutrality adjustment in the final rule on the basis of the
available 2013 utilization data at that time. We do not believe,
however, that the final values will change significantly from the
proposed values as a result of the final budget-neutrality adjustment.
Because of the differences in the sizes of the three fee schedule
components, implementation of the resource-based MP RVU update will
have much smaller payment effects than implementing updates of
resource-based work RVUs and resource-based PE RVUs. On average, work
represents about 50.9 percent of payment for a service under the fee
schedule, PE about 44.8 percent, and MP about 4.3 percent. Therefore, a
25 percent change in PE RVUs or work RVUs for a service would result in
a change in payment of about 11 to 13 percent. In contrast, a
corresponding 25 percent change in MP values for a service would yield
a change in payment of only about 1 percent. Estimates of the effects
on payment by specialty type can be found in section VI. of this
proposed rule.
Additional information on our proposed methodology for updating the
MP RVUs may be found in our contractor's report, ``Report on the CY
2015 Update of the Malpractice RVUs,'' which is available on the CMS
Web site. It is located under the supporting documents section of the
CY 2015 PFS proposed rule located at http://www.cms.gov/PhysicianFeeSched/.
3. MP RVU Update for Anesthesia Services
Since payment for anesthesia services under the PFS is based upon a
separate fee schedule, routine updates must be calculated in a
different way than those for services for which payment is calculated
based upon work, PE and MP RVUs. To apply certain updates to the
anesthesia fee schedule, we usually develop proxy RVUs for individual
anesthesia services. However, because work RVUs are integral to the MP
RVU methodology and anesthesia services do not have work RVUs, the MP
update process for anesthesia services is more complex than for
services with work RVUs and clinical labor inputs. Notwithstanding
these challenges, we believe that payment rates for anesthesia should
reflect relative MP resource costs, including updates to reflect
changes over time, as do other PFS payment rates. We are not proposing
to include such an adjustment at this time because we believe it would
be helpful to receive input from stakeholders on how we could address
these challenges and develop a proposal to appropriately update the MP
resource costs for anesthesia through future rulemaking. Therefore, we
intend to propose an anesthesia adjustment for MP in the CY 2016 PFS
proposed rule and are seeking comment in this rule about how to best do
so.
An example of one possible approach would be to calculate imputed
work RVUs and MP RVUs for the anesthesia fee schedule services using
the work, PE, and MP shares of the anesthesia conversion factor. To
reflect differences in the complexity and risk between
[[Page 40355]]
anesthesia fee schedule services we would then multiply the service-
specific risk factor for each anesthesia fee schedule service by the
imputed proxy work RVUs (both CY 2015 and Cy 2016 would be based on the
same work RVUs) developed for each anesthesia service to determine
updated proxy MP RVUs for the CY 2016 year. The aggregate difference
between the imputed MP RVUs for CY 2015 the proxy MP RVUs for CY 2016
(both based on the same work RVUs) would be applied to the portion of
the anesthesia conversion factor attributable to MP. However, we
believe there may be drawbacks to this approach since it relies heavily
on the proxy work and MP RVUs for individual anesthesia services. We
are requesting public comments on this approach specifically, as well
as comments on alternative approaches or methods for updating MP for
services paid on the anesthesia fee schedule.
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, CY 2011 and CY 2012, we phased in \1/2\ of the latest
GPCI adjustment in CY 2014. We also revised the cost share weights that
correspond to all three GPCIs in the CY 2014 PFS final rule. 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 have been 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. See Addenda D and E for the CY 2015 GPCIs and summarized GAFs.
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. 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
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
[[Page 40356]]
GPCI, for the Virgin Islands payment locality using aggregated 2009
through 2011 BLS OES data.
As discussed above, 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.
Table 16 illustrates the percentage change in GPCI values and
summarized GAF for the Virgin Islands payment locality resulting from
using BLS OES wage data to calculate the work GPCI and PE GPCI.
TABLE 16--Impact of Using Territory-Level Virgin Islands Data on GPCI Values for the Virgin Islands Payment Locality
--------------------------------------------------------------------------------------------------------------------------------------------------------
1/1/2015 through 3/31/2015 (with 1.0 work GPCI 4/1/2015 through 12/31/2015 (without 1.0 work
floor) GPCI floor)
-----------------------------------------------------------------------------------------------
GPCI/GAF Existing CY Proposed CY Existing CY Proposed CY
2015 GPCI 2015 GPCI Percent change 2015 GPCI 2015 GPCI Percent change
values* values values* values
--------------------------------------------------------------------------------------------------------------------------------------------------------
Work GPCI............................................... 1.000 1.000 0.00% 0.998 0.975 -2.30
PE GPCI................................................. 1.005 0.960 -4.48% 1.005 0.960 -4.48
MP GPCI................................................. 0.996 0.996 0.00% 0.996 0.996 0.00
GAF..................................................... 1.002 0.982 -2.00% 1.001 0.969 -3.20
--------------------------------------------------------------------------------------------------------------------------------------------------------
*CY 2015 GPCIs and GAF reflect CMS OACT BN adjustment.
Using aggregate territory-level BLS OES wage data results 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, there is no change in the MP GPCI. We propose to use
aggregate BLS OES wage data to calculate the work GPCI and employee
wage component of the PE GPCI for the Virgin Islands payment locality
beginning for CY 2015, and for future GPCI updates. We are specifically
requesting public comments on this proposal. Additional information on
our proposal to calculate 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 proposed rule located at http://www.cms.gov/PhysicianFeeSched/.
E. Medicare Telehealth Services
1. Billing and Payment for Telehealth Services
Generally, for Medicare payments to be made for telehealth services
under the PFS several conditions must be met. Specifically, the service
must be on the Medicare list of telehealth services and meet all of the
following other 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 for 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
provision, which was effective October 1, 2001, in the CY 2002 PFS
final rule with comment period (66 FR 55246). We established a process
in the CY 2003 PFS final rule with comment period (67 FR 79988) for
annual updates to the list of Medicare telehealth services as required
by section 1834(m)(4)(F)(ii) of the Act.
As specified in regulations 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 the telehealth service provision is 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
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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/hosptialcommunication.
Practitioners furnishing Medicare telehealth services submit claims
for telehealth services to the Medicare contractors that process claims
for the service area where their distant site is located. Section
1834(m)(2)(A) of the Act requires that a practitioner who furnishes a
telehealth service to an eligible telehealth individual be paid an
amount equal to the amount that the practitioner would have been paid
if the service had been furnished without the use of a
telecommunications system.
Originating sites, which are defined as ``one of the specified
sites where an eligible telehealth individual is located at the time
the service is being furnished via a telecommunications system,'' are
paid under the PFS for serving as an originating site for telehealth
services. The statute specifies both the types of entities that can
serve as originating sites and geographic qualifications for
originating sites. With regard to geographic qualifications, our
regulations at Sec. 410.78 (b)(4) limit 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 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/teleheath/.
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. We assign any qualifying request to make additions to
the list of telehealth services to one of two categories. In the
November 28, 2011 Federal Register (76 FR 73102), we finalized
revisions to criteria that we use to review requests in the second
category. The two categories are:
Category 1: Services that are similar to 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
[[Page 40358]]
stated in the CY 2012 proposed rule (76 FR 42826), we believe that the
category 1 criteria not only streamline our review process for
publically requested services that fall into this category, the
criteria also expedite our ability to identify codes for the telehealth
list that 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 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 are not proposing 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 furnished without the patient being present in the
same location. (Note: Sometimes an entirely different code may be 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.) 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. It is not necessary to consider including the PC of
these services on the telehealth list for these services to be covered
when furnished remotely. Moreover, when these 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, telehealth restrictions 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
[[Page 40359]]
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 are not
proposing 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
are not proposing 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 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
62.5 percent outpatient mental health treatment limitation, in effect
since the inception of the Medicare program, be reduced over four
years. This limitation limits the percentage of allowed charges that
the Medicare program paid for mental health treatment services, thus
creating a larger share of beneficiary coinsurance for these services
than other Medicare PFS services. Effective January 1, 2014, the
limitation percentage is 100 percent, of which Medicare pays 80 percent
and the beneficiary pays 20 percent, resulting in the same beneficiary
cost sharing as 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
Telehealth 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 are proposing 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 proposed rule, 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 also amended the
regulation at 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 many other mechanisms by which
we can make the public aware of the list of Medicare telehealth
services for each year, we are proposing 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. 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 are also
proposing to revise Sec. 410.78(f) to indicate that a list of Medicare
telehealth codes and descriptors is available on the CMS Web site.
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 its inception 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 potentially
misvalued code initiative under 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 in
order 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 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
[[Page 40360]]
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 asserted 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 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
[[Page 40361]]
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. They believe 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 range 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 as 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
gone down, 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 proposed rule for a
discussion of proposed valuation of these epidural injection codes for
CY 2015).
3. Alternatives to the Current Process
Although we continue to believe the existing process for new,
revised and potentially misvalued codes is an appropriate one given the
incongruity between our rulemaking schedule and the CPT and RUC
schedules, given our heightened review of the RUC recommendations and
the increased concerns expressed by some stakeholders, we believe that
an assessment of our process for valuing these codes is warranted. To
that end, we have 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 have
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.
A discussion of each of these alternatives 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 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 all codes in the
proposed rule for that year.
Therefore, 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
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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 a 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 in order 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 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
[[Page 40363]]
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 are proposing 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 propose 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. For the CY 2016
rulemaking process, we would include in the proposed rule proposed
values for all services for which we have RUC recommendations by
January 15, 2015.
For those codes for which we do not receive the RUC recommendations
by January 15th of a year, we would 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. 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
propose 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 practicable 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 describe services which 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 need to 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 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 propose to modify the regulation at Sec. 414.24 to codify the
process described above.
We recognize that the use of G-codes, especially if there are many
of them in a given year, may place an administrative burden on those
who bill
[[Page 40364]]
for services under the PFS. We also recognize that, to the extent we do
not receive RUC recommendations in time to include proposed values in
the proposed rule, the most updated version of some CPT codes would not
be used by the Medicare program for the first year. The AMA has been
working to develop timeframes that would allow a much greater
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 hopeful that if this proposal is adopted the CPT Editorial
Panel and the RUC ultimately will be able to adjust their timelines and
processes so that most, if not all, of the annual coding changes and
valuation recommendations can be addressed in the proposed rule prior
to the effective date of the coding changes.
As discussed previously, the work of the AMA through the CPT
Editorial Panel and the RUC are critical elements in the appropriate
valuation of services under the PFS. We have proposed implementation of
the revised CMS process for establishing values for new, revised, and
potentially misvalued codes for CY 2016; but would consider alternative
implementation dates to allow time for the CPT Editorial Panel and the
RUC to adjust their schedules to avoid the necessity to use G-codes.
With regard to this proposal, we would be specifically interested
in 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?
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 consider changes to the processes for valuing codes, we are
reassessing the role that the refinement panel process plays in the
code valuation process. As we note in the discussion above, the current
refinement panel process is tied to interim final values. It provides
an opportunity for stakeholders to provide 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. 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 a very few codes that
describe totally new services. Thus, we are proposing to eliminate the
refinement panel process. By using the proposed process for new,
revised, and potentially misvalued codes, we believe that the
consideration of additional clinical information and any other issues
associated with the CMS proposed values could be addressed through the
notice and public 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 note that an increasing number of requests for
refinement do not include new clinical information that was not
available at the time of the RUC meeting that would justify a change in
the work RVUs, in accordance with the current requirements for
refinement. Thus, we do 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.
G. 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 Center 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).
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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 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 two or more chronic conditions. (See 78 FR 74414 for
a more complete description of the beneficiaries for whom this service
may be billed.) In the CY 2014 PFS final rule with comment period, we
indicated that, to recognize the additional resources required to
provide 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 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 used the work RVU and work time associated with the
non-face-to-face portion of CPT code 99495 as a foundation to determine
our proposed values for CCM services. Specifically, we are proposing 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 are proposing 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. The work time file associated with this PFS
proposed rule is available on the CMS Web site in the Downloads section
for the CY 2015 PFS proposed rule at http://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/PhysicianFeeSched/PFS-Federal-Regulation-Notices.html.
For direct PE inputs, we are proposing 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 believe that many aspects of this service will be provided
by clinical staff, and thus, clinical staff will be involved in the
typical service for the full 20 minutes. The proposed CY 2015 direct PE
input database reflects this input 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 proposed PE
RVUs included in Addendum B to this proposed rule reflect the RVUs that
result from using these inputs to establish PE RVUs.
The proposed MP RVU was calculated using the weighted risk factors
for the specialties that we believe will furnish this service. We
believe this malpractice risk factor appropriately reflects the
relative malpractice risk associated with furnishing CCM services. The
MP RVU included in Addendum B of this proposed rule reflects the RVU
that results from the application of this proposal.
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 (75 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
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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
the availability to a beneficiary 24-hours-a-day, 7-days-a-week to
address the patient's chronic care needs (78 FR 74426) that 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 patient'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 patients 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 this rule, we are proposing to revise the policy that we adopted
in the CY 2014 PFS final rule with comment period, and to amend our
regulations to codify the requirements for CCM services furnished
incident to a practitioner's services. Specifically, we are proposing
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 are also proposing
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 requirements of
the ``incident to'' regulations at Sec. 410.26 are met.
We are proposing 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 health
care practitioners in the practice to address a patient'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'' under general supervision if the
auxiliary personnel providing the services in conjunction with CCM
services are clinical staff, and whether or not they are direct
employees of the practitioner or practice billing for the service; but
the clinical staff must meet the requirements for auxiliary personnel
contained in 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 are also proposing 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 patients. 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 are not proposing to
extend this policy to the E/M service that is a required element of
TCM. Rather, the required E/M service must still be furnished under
direct supervision.
Therefore, we are proposing 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
[[Page 40367]]
``incident to'' service is based. We note that all other ``incident
to'' requirements continue to apply and that documentation of services
provided must be included in the medical record.
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
services required in order for a practitioner to bill Medicare for CCM
services. 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 this 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, 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 had 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 already in place for health care
practitioners and that will apply to those who furnish and bill for CCM
services, we have decided not to propose an additional set of standards
that must 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 have 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.
In one area--that of electronic health records--we are 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 beneficiary and
among health care practitioners treating the beneficiary. As a part of
the CY 2014 PFS final rule with comment period (78 FR 43338 through
43339), we specified that the electronic health record for a patient
receiving CCM services should include a full list of problems,
medications and medication allergies in order to inform the care plan,
care coordination, and ongoing clinical care. Furthermore, those
furnishing CCM services must be able to facilitate communication of
relevant patient information through electronic exchange of a summary
care record with other health care providers as a part of managing
health care transitions. We believe that if care is to be coordinated
effectively, all communication must be timely, and it must include the
information that each team member needs to know to furnish care that is
congruent with a patient's needs and preferences. In addition, those
furnishing CCM services need to establish reliable flows of information
from emergency departments, hospitals, and providers of post-acute care
services to track their CCM patients receiving care in those settings.
Reliable information flow supports care transitions, and can be used to
assess the need for modifications of the care plan that will reduce the
risk of readmissions, increased morbidity, or mortality.
After gathering input from stakeholders, we believe that requiring
those who furnish CCM services to utilize electronic health record
technology that has been certified by a certifying body authorized by
the National Coordinator for Health Information Technology will ensure
that practitioners have adequate capabilities to allow members of the
interdisciplinary care team to have immediate access to the most
updated information informing the care plan. Furthermore, we believe
that requiring those that furnish CCM services to maintain and share an
electronic care plan will alleviate the development of duplicative care
plans or updates and the associated errors that can occur when care
plans are not systematically reconciled. To ensure that practices
offering CCM services meet these needs, we are proposing a new scope of
service requirement for electronic care planning capabilities and
electronic health records. Specifically, we are proposing that CCM
services must be furnished with the use of an electronic health record
or other health IT or health information exchange platform that
includes an electronic care plan that is accessible to all providers
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. To ensure all practices have adequate capabilities to meet
electronic health record requirements, 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 electronic health record certification criteria identified in the
then-applicable version of 45 CFR part 170. 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. For example, practitioners furnishing CCM services beginning in
CY 2015 would be required to utilize an electronic health record
certified to at least those 2014 Edition certification criteria. Given
these certification criteria, 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)). When any of the CCM scope of service requirements
include a reference to a health or medical record, a system meeting
these requirements is required.
We believe this scope of service element will ensure that
practitioners have adequate capabilities to fully
[[Page 40368]]
furnish CCM services, allow practitioners to innovate around the
systems that they use to furnish these services, and avoid
overburdening small practices. We believe that allowing flexibility as
to how providers capture, update, and share care plan information is
important at this stage given the maturity of current electronic health
record 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 are seeking 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.
To assist stakeholders in commenting, we remind you of the elements
of the current scope of service for CCM services that are required in
order for a practitioner to bill Medicare for CCM services as finalized
in the CY 2014 final rule with comment period. We would note that
additional explanation of these elements can be found at 78 FR 74414
through 74428. The CCM service includes:
Access to care management services 24-hours-a-day, 7-days-
a-week, which means providing beneficiaries 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 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.
Creation of a patient-centered care plan document to
assure that care is provided in a way that is congruent with patient
choices and values. A plan of care 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.
Management of care transitions between and among health
care providers and settings, including referrals to other clinicians,
follow-up after a beneficiary visit to an emergency department, and
follow-up after discharges from hospitals, skilled nursing facilities,
or other health care facilities.
Coordination with home and community based clinical
service providers as appropriate to support a beneficiary's 's
psychosocial needs and functional deficits.
Enhanced opportunities for a 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 remind stakeholders that in the CY 2014 final rule,
we established particular billing requirements for CCM services that
require the practitioner to:
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 patient's medical record that all of the
CCM services were explained and offered to the patient, 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.
Inform the beneficiary of the right to stop the CCM
services at any time (effective at the end of a 30-day period) and the
effect of a revocation of the agreement on CCM services.
Inform the beneficiary that only one practitioner can
furnish and be paid for these services during the 30-day period.
With the addition of the electronic health record element that we
are proposing, we believe that these elements of the scope of service
for CCM services, when combined with other important federal health and
safety regulations, provide sufficient assurance that Medicare
beneficiaries receiving CCM services will receive appropriate services.
However, we remain interested in receiving public feedback regarding
any meaningful elements of the CCM service or beneficiary protections
that may be missing from these scope of service elements and billing
requirements. We encourage commenters, in recommending additional
possible elements or safeguards, to provide as much specific detail as
possible regarding their recommendations and how they can be applied to
the broad complement of practitioners who may furnish CCM services
under the PFS.
4. Payment of CCM Services in CMS Models and Demonstrations
As discussed above, several CMS models and demonstrations address
payment for care management services. The Multi-payer Advanced Primary
Care Practice Demonstration and the Comprehensive Primary Care
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 propose 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 propose 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
affecting existing models or demonstrations, we will address potential
overlaps with CCM and seek to implement appropriate reimbursement
policies. We welcome comments on this proposal. We also solicit
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.
H. Definition of Colorectal Cancer Screening Tests
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
[[Page 40369]]
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 standard of care for screening
colonoscopies has been moderate sedation provided intravenously by the
endoscopist, without resort to separately provided anesthesia.\1\ Based
on this standard of care, 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.
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\1\ 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.\2\ A 2010 study projected that the percentage of
this class of procedures involving an anesthesia professional would
grow to 53.4 percent by 2015.\3\ These studies suggest that the
prevailing standard of care 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. After reviewing these studies, we
analyzed Medicare claims data and found that the same trend was
observed in screening colonoscopies for Medicare beneficiaries. We
found that in 53 percent of screening colonoscopies for which Medicare
claims were submitted in 2013 a separate anesthesia claim was reported.
---------------------------------------------------------------------------
\2\ 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.
\3\ 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.
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In light of these developments, we are concerned that the mere
reference to ``screening colonoscopies'' in the definition of
``colorectal cancer screening tests'' has become inadequate. Indeed, we
are 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 believe it
is appropriate to revise the definition of ``colorectal cancer
screening tests'' to adequately reflect these new patterns.
Accordingly, we are proposing 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.
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
4104 of the Affordable Care Act, which amended section 1833(a)(1) of
the Act to require 100 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 effectively waives any Part B coinsurance that would
otherwise apply under section 1833(a)(1) of the Act 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 note 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). If adopted, we believe this proposal will
encourage 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 are
exercising our authority under section 1861(pp)(1)(D) of the Act to
propose a revision to 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
[[Page 40370]]
furnished in conjunction with a screening colonoscopy.
We note that, in implementing these proposed revisions to the
regulations, it will 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. If we adopt this
proposal in the final rule, we will 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 note that the valuation of
colonoscopy codes, which include moderate sedation, will be subject to
the same proposed review as other codes that include moderate sedation,
as discussed in section II.B.6 of this proposed rule.
I. Payment of Secondary Interpretation of Images
In general, Medicare makes one payment for the professional
component of an imaging service for each technical component service
that is furnished. Section 100.1, Chapter 13, of the Medicare Claims
Processing Manual (Pub. 100-04) explains this policy in the context of
EKGs and X-rays furnished in an Emergency Room. The manual section
discusses the distinction between a ``review'' of an X-ray or EKG for
which payment is included in the payment for the emergency department
E/M payment, and the ``interpretation and report'' of an X-ray or EKG
which can be billed separately and includes a written report addressing
``the findings, relevant clinical issues, and comparative data (when
available).'' The section makes clear that a ``professional component''
interpretation service should only be billed for a full interpretation
and report. The manual section goes on to explain that, in general,
Medicare pays for only one interpretation of an EKG or X-ray service
furnished to an emergency room patient. However, Medicare can pay for a
second interpretation (which is billed using modifier -77) under
``unusual circumstances (for which documentation is provided).'' For
instance, if an emergency room physician conducts an interpretation,
identifies a questionable finding, and believes another physician's
expertise is needed, then a second claim for an interpretation can be
paid when furnished, for example, by a radiologist. The second
interpretation must directly contribute to the diagnosis and treatment
of the individual patient (rather than serving as a quality control
measure), and the second interpretation must also be accompanied by a
written report.
While a separate payment for the professional component for a
radiology service is contingent upon meeting the conditions described
in this section, practitioners bill Medicare and are paid for reviews
of radiology images in other ways. For instance, review of a patient's
previous radiology images is included and paid as part of the review of
previous documentation in conjunction with E/M services. Reviews of
extensive documentation and efforts to obtain previous documentation
including existing imaging studies are considerations in deciding the
appropriate level of complexity for evaluation and management
services.\4\
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\4\ See, for example, 1997 Documentation Guidelines for
Evaluation and Management Service, p. 45.
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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. These advances offer
new opportunities for physicians to reduce duplicative imaging,
particularly with respect to high cost advanced diagnostic imaging
modalities. For instance, a trauma patient transferred from a community
hospital to a tertiary care center may arrive with high quality CT
images sufficient to support an additional professional interpretation
service. By accessing and utilizing these images to inform the
diagnosis and record an interpretation in the medical record at the
tertiary care facility, the provider and physicians may be able to
avoid ordering substantially duplicative tests.
Questions have arisen as to whether and under what circumstances it
would be appropriate for Medicare to permit payment under the PFS when
physicians furnish subsequent interpretations of existing images, and
whether uncertainty associated with payment for secondary
interpretations inhibits physicians from seeking out, accessing, and
utilizing existing images in cases where avoidance of a new study would
result in savings to Medicare. We are seeking comment to assess whether
there is an expanded set of circumstances under which it would be
appropriate to allow more routine Medicare payment for a second
professional component for radiology services, and whether such a
policy would be likely to reduce the incidence of duplicative advanced
imaging studies.
Specifically we are seeking comment on the following questions:
For which radiology services are physicians currently
conducting secondary interpretations, and what, if any, institutional
policies are in place to determine when existing images are utilized?
To what extent are physicians seeking payment for these secondary
interpretations from Medicare or other payers?
Should routine payment for secondary interpretations be
restricted to certain high-cost advanced diagnostic imaging services,
such as those defined as such under section 1834(e)(1)(B) of the Act,
for example, diagnostic magnetic resonance imaging, computed
tomography, and nuclear medicine (including positron emission
tomography)?
How should the value of routine secondary interpretations
be determined? Is it appropriate to apply a modifier to current codes
or are new HCPCS codes for secondary interpretations necessary?
We believe most secondary interpretations would be likely
to take place in the hospital setting. Are there other settings in
which claims for secondary interpretations would be likely to reduce
duplicative imaging services?
Is there a limited time period within which an existing
image should be considered adequate to support a secondary
interpretation?
Would allowing for more routine payment for secondary
interpretations be likely to generate cost savings to Medicare by
avoiding potentially duplicative imaging studies?
What operational steps could Medicare take to ensure that
any routine payment for secondary interpretations is limited to cases
where a new imaging study has been averted while minimizing undue
burden on providers or Part B contractors? For instance, steps might
include restricting physicians' ability to refer multiple
interpretations to another physician that is part of their network or
group practice, requiring that physicians attach a physician's order
for an averted imaging study to a claim for a secondary interpretation,
or requiring physicians to identify the technical component of the
existing image supporting the claim.
We seek comments on these questions, and welcome input on any
additional considerations not mentioned here regarding the potential
[[Page 40371]]
impact of allowing payment for secondary interpretation of images under
other circumstances. Upon reviewing the comments received, we will
consider whether any further action is appropriate, for instance,
proposing under a future rulemaking to allow for payment of subsequent
interpretations of advanced diagnostic images in lieu of duplicative
studies.
J. Conditions Regarding Permissible Practice Types for Therapists in
Private Practice
Section 1861(p) of the Act defines outpatient therapy services to
include physical therapy, occupational therapy, and speech-language
pathology 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 occupational
therapy (OT), physical therapy (PT), and speech-language pathology
(SLP), 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 recent review of these
three sections of our regulations, we are 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 are proposing
changes to the regulatory language to remove unnecessary distinctions
and redundancies within the regulations for OT, PT, and SLP. We note
that these proposed changes are for clarification only, and do not
reflect any proposed 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
(for occupational therapists, physical therapists and speech-language
pathologists), we propose to replace the regulatory text at Sec.
410.59(c)(1)(ii)(A) through (E), Sec. 410.60(c)(1)(ii)(A) though (E),
and Sec. 410.62(c)(1)(ii)(A) through (E).
K. Payments for Physicians and 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 are 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 physician or practitioner furnishes a complete
assessment of the ESRD beneficiary, the MCP physician or 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 physician or 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. Stakeholders have
recently brought this inconsistency to our attention. After reviewing
this issue, we are proposing 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 physician or 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 physician
or practitioner should bill for the full home dialysis MCP service. We
believe that this proposed change to home dialysis (less than a full
month) provides consistency with our policy for partial month scenarios
pertaining to patients dialyzing in a dialysis center. 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.
III. Other Provisions of the Proposed Regulations
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) 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
[[Page 40372]]
through March 31, 2015. Thus, these payment add-ons also apply to
covered ground ambulance transports furnished before April 1, 2015. We
are proposing to revise Sec. 414.610(c)(1)(ii) to conform the
regulations to these statutory requirements. (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.
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 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 Public Law 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. Accordingly, we are proposing to revise Sec.
414.610(c)(5)(ii) to conform the regulations to these statutory
requirements. (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.
B. Proposed 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 Proposed 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
[[Page 40373]]
December 27, 2000 (65 FR 82228 through 82238) and 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 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).
While 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, 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. Because the bulletin was not
issued until February 28, 2013, with supporting data not available
until later, and because the changes made by the bulletin and their
ramifications needed to be extensively reviewed and verified, we were
unable to undertake such a lengthy process before publication of the CY
2014 PFS proposed rule, and thus, did not implement the changes to the
OMB delineations under the ambulance fee schedule for CY 2014. We have
reviewed our findings and impacts relating to the new OMB delineations,
and find no compelling reason to further delay implementation. We
believe it is important for the ambulance fee schedule to use the
latest labor market area delineations available as soon as reasonably
possible in order 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. 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 are proposing 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
the most recent version of the Goldsmith Modification. 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.
These rural census tracts are considered rural areas under the
ambulance fee schedule (see Sec. 414.605). 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 are
proposing 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. 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.
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.
[[Page 40374]]
(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 would 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 HRSA's Web site: ftp://ftp.hrsa.gov/ruralhealth/Eligibility2005.pdf for additional
information. Consistent with the HRSA guidelines discussed above, we
are proposing, 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. As discussed in the CY 2007 PFS final rule (71 FR 69715), 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 invite comments on this
proposal.
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, 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). 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.
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)).
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. 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. The
geographic designations for approximately 99.48 percent of ZIP codes
would be unchanged by OMB's revised delineations and the updated RUCA
codes. There are a similar number of ZIP codes that would change from
rural to urban (122, or 0.28 percent) and from urban to rural (100, or
0.23 percent). In general, it is 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. The
state of Ohio would have the most ZIP codes changing from urban to
rural with a total of 40, or 2.69 percent. 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. 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 are illustrated in Table 17.
[[Page 40375]]
Table 17--ZIP Codes Analysis Based on OMB's Revised Delineations and Updated RUCA Codes
--------------------------------------------------------------------------------------------------------------------------------------------------------
Percentage of
Total ZIP Total ZIP Percentage of Total ZIP Percentage of Total ZIP total ZIP
State codes codes changed total ZIP codes changed total ZIP codes not codes not
rural to urban codes urban to rural codes changed changed
--------------------------------------------------------------------------------------------------------------------------------------------------------
AK...................................... 276 0 0.00 0 0.00 276 100.00
AL...................................... 854 0 0.00 0 0.00 854 100.00
AR...................................... 725 0 0.00 3 0.41 722 99.59
AS...................................... 1 0 0.00 0 0.00 1 100.00
AZ...................................... 569 0 0.00 0 0.00 569 100.00
CA...................................... 2723 0 0.00 0 0.00 2723 100.00
CO...................................... 677 0 0.00 0 0.00 677 100.00
CT...................................... 445 15 3.37 0 0.00 430 96.63
DC...................................... 301 0 0.00 0 0.00 301 100.00
DE...................................... 99 1 1.01 0 0.00 98 98.99
EK...................................... 63 0 0.00 0 0.00 63 100.00
EM...................................... 856 0 0.00 3 0.35 853 99.65
FL...................................... 1513 5 0.33 0 0.00 1508 99.67
FM...................................... 4 0 0.00 0 0.00 4 100.00
GA...................................... 1032 4 0.39 0 0.00 1028 99.61
GU...................................... 21 0 0.00 0 0.00 21 100.00
HI...................................... 143 0 0.00 0 0.00 143 100.00
IA...................................... 1080 5 0.46 0 0.00 1075 99.54
ID...................................... 335 0 0.00 0 0.00 335 100.00
IL...................................... 1628 0 0.00 0 0.00 1628 100.00
IN...................................... 1000 1 0.10 14 1.40 985 98.50
KY...................................... 1030 0 0.00 0 0.00 1030 100.00
LA...................................... 739 2 0.27 0 0.00 737 99.73
MA...................................... 751 0 0.00 4 0.53 747 99.47
MD...................................... 630 9 1.43 0 0.00 621 98.57
ME...................................... 505 0 0.00 0 0.00 505 100.00
MH...................................... 2 0 0.00 0 0.00 2 100.00
MI...................................... 1185 4 0.34 8 0.68 1173 98.99
MN...................................... 1043 1 0.10 0 0.00 1042 99.90
MP...................................... 3 0 0.00 0 0.00 3 100.00
MS...................................... 541 0 0.00 0 0.00 541 100.00
MT...................................... 411 0 0.00 0 0.00 411 100.00
NC...................................... 1101 12 1.09 5 0.45 1084 98.46
ND...................................... 418 0 0.00 0 0.00 418 100.00
NE...................................... 632 0 0.00 0 0.00 632 100.00
NH...................................... 292 0 0.00 0 0.00 292 100.00
NJ...................................... 747 0 0.00 0 0.00 747 100.00
NM...................................... 438 0 0.00 0 0.00 438 100.00
NV...................................... 257 0 0.00 0 0.00 257 100.00
NY...................................... 2246 4 0.18 0 0.00 2242 99.82
OH...................................... 1487 6 0.40 40 2.69 1441 96.91
OK...................................... 791 0 0.00 0 0.00 791 100.00
OR...................................... 494 6 1.21 0 0.00 488 98.79
PA...................................... 2244 8 0.36 0 0.00 2236 99.64
PR...................................... 177 0 0.00 0 0.00 177 100.00
PW...................................... 2 0 0.00 0 0.00 2 100.00
RI...................................... 91 0 0.00 0 0.00 91 100.00
SC...................................... 543 7 1.29 0 0.00 536 98.71
SD...................................... 418 0 0.00 0 0.00 418 100.00
TN...................................... 814 2 0.25 0 0.00 812 99.75
TX...................................... 2726 0 0.00 1 0.04 2725 99.96
UT...................................... 359 0 0.00 0 0.00 359 100.00
VA...................................... 1277 8 0.63 17 1.33 1252 98.04
VI...................................... 16 0 0.00 0 0.00 16 100.00
VT...................................... 309 0 0.00 0 0.00 309 100.00
WA...................................... 744 2 0.27 0 0.00 742 99.73
WI...................................... 919 3 0.33 0 0.00 916 99.67
WK...................................... 711 0 0.00 2 0.28 709 99.72
WM...................................... 342 0 0.00 0 0.00 342 100.00
WV...................................... 936 17 1.82 3 0.32 916 97.86
WY...................................... 198 0 0.00 0 0.00 198 100.00
---------------------------------------------------------------------------------------------------------------
Totals.............................. 42914 122 0.28 100 0.23 42692 99.48
--------------------------------------------------------------------------------------------------------------------------------------------------------
We believe that 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 that use of the most current OMB delineations and RUCA
codes under the ambulance fee schedule would enhance
[[Page 40376]]
the accuracy of ambulance fee schedule payments. We invite 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.
C. Clinical Laboratory Fee Schedule
In the CY 2014 PFS final rule with comment period (78 FR 74440-
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, 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 are not
proposing any revisions to payment amounts for test codes on the CLFS
based on technological changes and are proposing to remove Sec.
414.511. Instead, we will establish through rulemaking the parameters
for 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 requirements for furnishing services in RHCs and FQHCs,
see Chapter 13 of the CMS Benefit Policy Manual.)
In the May 2, 2014 final rule with comment period (79 FR 25436)
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,'' 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 section
1861(aa)(2)(iii) 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. The regulations at
Sec. 405.2413(a)(6), Sec. 405.2415(a)(6), and Sec. 405.2452(a)(6)
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.
2. Provisions of Proposed Rule
To provide RHCs and FQHCs with as much flexibility as possible to
meet their staffing needs, we are proposing 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 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.
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 XX 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
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
[[Page 40377]]
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 propose 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 propose 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 signals 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 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 propose 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. If finalized, this regulation
will provide clear legal authority for 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 Safe Guards
(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, these data
will be covered under a CMS established system of records (System No.
09-70-0591), which serves as the Master system for all demonstrations,
evaluations, and research studies administered by the Innovation
Center. These data will be stored until the evaluation is complete and
all necessary 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 proposed rule. Such data may include the identities of the
patients served under the model, relevant clinical details about the
services furnished and outcomes
[[Page 40378]]
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
Center 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 invite 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 are proposing a new subpart K in part 403 to
implement section 1115A of the Act.
F. Local Coverage Determination Process for Clinical Diagnostic
Laboratory Testing
1. Background
On April 1, 2014, the PAMA was enacted and section 216 addresses
Medicare payment and coverage policies for clinical diagnostic
laboratory testing. In regard to coverage policies, section 216 amended
the statute by adding section 1834A(g) of the Act, which establishes
mandates related to issuance of local coverage policies by the Medicare
Administrative Contractors (MACs) for clinical diagnostic laboratory
tests. The law states: ``A medicare administrative contractor shall
only issue a coverage policy with respect to a clinical diagnostic
laboratory test in accordance with the process for making a local
coverage determination (as defined in section 1869(f)(2)(B)), including
the appeals and review process for local coverage determinations under
part 426 of title 42, Code of Federal Regulations (or successor
regulations).''
Section 1869(f)(2)(B) of the Act defines a local coverage
determination (LCD) as ``a determination by a fiscal intermediary or a
carrier under Part A or Part B, as applicable, respecting whether or
not a particular item or service is covered on an intermediary-or
carrier-wide basis under such parts, in accordance with section
1862(a)(1)(A) of the Act.''
Since the new law requires that the process for making local
coverage determinations be used as the vehicle for local coverage
policies for clinical diagnostic laboratory tests, it is important that
we carefully consider the LCD process that is used today and determine
if there are certain, limited aspects of the LCD process that may
provide an opportunity to better fit the needs of this particular area
of medicine. In addition to the current LCD process, we will examine
how the LCD process was applied to a pilot project for molecular
diagnostic tests as we are learning important lessons from this ongoing
pilot. We believe lessons learned from this project can be applied to
all clinical diagnostic laboratory testing and not just molecular
diagnostic tests (which are encompassed under the PAMA requirement for
local coverage policies). In this proposed process, we will review the
current LCD process, as well as the pilot in support of a proposal to
create, consistent with the requirements set forth under the PAMA, an
expedited LCD process for clinical diagnostic laboratory testing.
The current LCD process (Table 18) requires that a draft LCD be
published in the Medicare Coverage Database (MCD). This serves as a
public announcement that an LCD is being developed. Once a draft LCD is
published, at least 45 calendar days are provided for public comment.
We note that the National Coverage Determination (NCD) process only
requires a 30-day public comment period after a proposed NCD is
published. This timeframe is based on the NCD statutory requirements
under 1862(l) of the Act and in our experience at the national policy
level, 30 days is generally adequate to allow for robust public
comment.
After the draft LCD is made public, MACs are required to hold an
open meeting to discuss the draft LCD with stakeholders. In addition to
the open meeting, the MACs present the draft policy to the Carrier
Advisory Committee (CAC). These two aspects of LCD development can be
time-consuming and may involve logistical complications that extend the
length of time it takes to reach a final policy. We note that unlike
the national advisory committee, the Medicare Evidence Development and
Coverage Advisory Committee (MEDCAC), the CAC meetings and open
stakeholder meetings are scheduled to discuss many LCD policies at a
time as opposed to narrowly focusing on one policy. Due to the
resources required, the constant development of LCDs and scheduling
considerations, MACs do not hold ad hoc meetings. Both the open
stakeholder meetings and the CAC meetings are scheduled far in advance,
generally at the start of the calendar year before MACs know which
policies will be presented in these forums. The timing of the open
stakeholder meeting, CAC meeting, and public release of the draft LCD
are all factors in determining which LCDs are on the agendas. Because
of these scheduling issues, some LCDs may not have to wait as long for
a CAC meeting or an open stakeholder meeting while others could have
lengthy delays. In contrast, at the national level, MEDCACs are not
convened for every NCD and separate open meetings are also not a part
of the NCD process. Based on our experience with the NCD process over
the past decade, we believe that public input is now readily available
through more technologically advanced mechanisms of collecting public
comment. For example, the information gathered and knowledge gained
from the LCD open stakeholder meetings may now be acquired more broadly
through the collection of public comments via web-based applications.
CMS and its contractors are receiving more input on their policies
because of these technology advances, which were not as available to
the public when the LCD manual was originally written approximately 25
years ago. Medical literature, clinical practice guidelines,
complicated charts and graphs can now be easily submitted
electronically through the public comment process. Questions or follow-
up information from a specific commenter can be addressed through
conference calls or email. In addition, through these processes, all
public comments are available to everyone rather than to the few people
who attend meetings in
[[Page 40379]]
person. In addition to publishing a draft LCD, MACs publish a document
that provides a summary of all of the comments received and responses
to those comments. This allows the public to understand the reasoning
behind the final LCD and to know that all of the public comments were
taken under consideration as the MAC developed the final policy. Since
this information is made readily available in writing, an open meeting
is no longer necessary for the public to be heard. There are more
efficient methods available to the public to submit comments and
additional evidence that supports or rejects the application of a draft
LCD.
Somewhat different considerations apply to CACs, which are state-
specific bodies representing the clinical expertise of a geographic
area. CACs allow a unique opportunity for CAC members to provide
practical information regarding a draft policy since they are the
entities actually delivering services in the community. However, like
MEDCACs, a CAC may not be needed in all instances for the creation or
revision of an LCD. CAC meeting agendas can quickly fill up with draft
LCDs since the CAC meetings are scheduled far in advance. We believe
CACs may be a better resource and used more efficiently in the
development of LCDs if the MAC is able to select which draft LCDs are
presented to a CAC for discussion, as opposed to taking all LCDs to the
CAC. Of note, NCDs that go before the MEDCAC are selected by the agency
and it is not part of the process for every NCD.
Under the current LCD process, after the close of the comment
period and the required meetings, the MAC publishes a final LCD. As
stated earlier, the MAC must also respond to any comments received, via
a comment/response document. A notice period of at least 45 calendar
days is then required before the LCD can take effect. While it takes
time for the provider community and the claims processing systems to
adapt to changes in coverage, a notice period delays the date of when
coverage may be become effective.
In addition to evaluating the effectiveness of certain aspects of
the LCD implementation process, we are also examining a pilot project
that CMS launched with a single MAC, Palmetto GBA, on November 1, 2011.
While the pilot discussed in this section only includes molecular
diagnostic (genetic) laboratory tests, a subset of all clinical
diagnostic lab tests, we believe the pilot's design and some of the
lessons learned from the pilot can be applied to all clinical
diagnostic laboratory tests
For background, the universe of molecular diagnostic laboratory
tests is vast and the current LCD process can be lengthy for some of
these innovative tests, which are technically complex. For example,
multiple molecular diagnostic tests designated to diagnose the same
disease may rely on different underlying technologies and, therefore,
have significantly different performance characteristics. It would not
be appropriate to assume that all tests for a particular condition
behave the same. Because of these complexities, we have an obligation
to consider the evidence at a granular level; that is, to ensure
coverage of the appropriate test for the appropriate Medicare
beneficiary.
The pilot project's long-term goal was to assist clinicians by
determining whether the molecular diagnostic tests they order actually
perform as expected and, thus, ultimately improve clinical care. This
goal stemmed from concerns that some tests were being marketed directly
to physicians without information regarding the test's performance. The
pilot project sought to achieve this goal by identifying all of the
molecular diagnostic tests that Medicare was covering in the Palmetto
MAC jurisdiction. This required the ability to uniquely identify tests
through test registration and assignment of an identifier. In addition,
the MAC reviewed clinical statements made by the manufacturer for each
molecular diagnostic test to ensure the test was delivering what was
being claimed. Essentially, the pilot project facilitated claims
processing, tracked utilization, and determined clinical validity,
utility and coverage through technical assessments of published test
data.
As part of the pilot project, Palmetto wrote a single molecular
diagnostic laboratory testing LCD that outlined the framework they
would follow in determining coverage of all molecular diagnostic tests
in their jurisdiction. Additionally, that LCD included a list of
covered molecular diagnostic tests. Moreover, Palmetto issued several
articles addressing various other aspects of the LCD implementation
process, including coding guidelines, billing and medical review
procedures. There is much information that is not contained in the body
of an LCD that is necessary for consistent and predictable claims
processing and payment.
We believe a process that ensures transparency and stakeholder
participation can be achieved without utilizing the current LCD process
in its entirety. Some key aspects of the process should be maintained
such as allowing public comment on draft LCDs and requiring MAC
responses to public comments. However, we believe other aspects could
be streamlined to allow more timely decisions and a more efficient
process.
2. Proposed New LCD Process for Clinical Diagnostic Laboratory Tests
After assessment of the current LCD process, the Palmetto pilot
project, the requirements of the PAMA, and the vast field of clinical
diagnostic laboratory tests, including molecular diagnostic tests, we
are proposing a revised LCD process for all new draft clinical
diagnostic laboratory test LCDs published on or after January 1, 2015.
This process would carefully balance the need for an expedited process
to handle the vast number of clinical diagnostic laboratory tests,
including the rapidly growing universe of molecular diagnostic tests.
The National Institutes of Health (NIH)-sponsored Genetic Testing
Registry (GTR) currently includes 16,000 registered genetic tests for
over 4,000 conditions (www.ncbi.nlm.nih.gov/gtr/). We have a
responsibility to ensure that appropriate tests are covered by Medicare
and that coverage is limited to tests for which the test results are
used by the ordering physician in the management of the beneficiary's
specific medical problem (as required in Sec. 410.32(a)). Coverage for
diagnostic laboratory tests may be achieved through various policy
vehicles, including an NCD, LCD, or claim-by-claim adjudication at the
local contractor level. For most molecular diagnostic tests, coverage
has been determined by the MACs, through LCDs or claim-by-claim
adjudication. Few such tests have been the subject of an NCD, to date.
This concentration of coverage decisions at the local level, and the
responsibility of the agency to allow coverage of appropriate tests
provide additional reasons to provide MACs with a more streamlined LCD
process.
Based on these considerations, we are proposing a new LCD process
that would apply only to clinical diagnostic laboratory tests.
Specifically, we are proposing to establish a process MACs must follow
when developing clinical diagnostic laboratory test LCDs and
encouraging MACs to collaborate on such policies across jurisdictions.
We propose that the process apply to all new clinical diagnostic
laboratory testing draft LCDs published on or after January 1, 2015.
Consistent with Chapter 13, section 13.7.3 of the Medicare Program
Integrity Manual (PIM), however, we further propose that this process
will not apply to clinical diagnostic laboratory testing LCDs that are
being revised for the following
[[Page 40380]]
reasons: to liberalize an existing LCD; being issued for a compelling
reason; making a non-substantive correction; providing a clarification;
making a non-discretionary coverage or diagnosis coding update; making
a discretionary diagnosis coding update that does not restrict; or
revising to effectuate an Administrative Law Judge's decision on a
Benefits Improvement and Protection Act (BIPA) 522 challenge.
The proposed new process would allow any person or entity to
request an LCD or the MAC to initiate an LCD regarding clinical
diagnostic laboratory testing. After this external request or internal
initiation, the MAC would publish a draft LCD in the Medicare Coverage
Database (http://www.cms.gov/medicare-coverage-database/overview-and-quick-search.aspx), thereby making the draft LCD publicly available.
Next, a minimum of 30 calendar days for public comment would be
required. We note that in the event that stakeholders and/or members of
the public are not able to submit comments within the 30 calendar day
window, the MAC would have discretion to extend the comment period. We
would expect the draft LCDs to outline the criteria the MAC would use
when determining whether a specific clinical diagnostic laboratory test
or a group of tests are covered or non-covered. The MAC would review,
analyze, and take under consideration all public comments on the draft
LCD. For draft LCDs where the MAC determines that a CAC meeting would
contribute to the quality of the final policy, the MAC has discretion
to take draft LCDs to the CAC. In the event the MAC involves the CAC in
the development of an LCD, we would require that the public comment
period be extended to allow for the CAC to be held before the final
policy is issued. The MAC would be required to respond to all public
comments in writing and post their responses on a public Web site. As a
final step, the MAC would publish the final LCD in the Medicare
Coverage Database no later than 45 calendar days after the close of the
comment period. We believe 45 days to be an adequate time for the MAC
to take all comments under consideration, prepare responses to those
comments, and develop a final policy.
The final LCD would be effective immediately upon publication. This
effective date would be different than under the current LCD process
(which includes a notice period of at least 45 calendar days before a
final LCD is effective); however, based on our experience with NCDs,
which are also effective upon publication, we believe this is an
efficient mechanism to make tests available to beneficiaries more
quickly.
3. Reconsideration Process
The proposed process for developing clinical diagnostic laboratory
testing LCDs would not change the LCD reconsideration process as
outlined in the PIM in Chapter 13. This section of the manual allows
interested parties the opportunity to request reconsideration of an
LCD. Under the proposed process, the MACs would continue to implement
all sections of the PIM that relate to the LCD reconsideration process.
4. LCD Challenge Process
The proposed process for clinical diagnostic laboratory testing
LCDs would also not change any of the current review processes
available to an aggrieved party. An aggrieved party would continue to
be able to challenge an LCD according to the requirements set out in 42
CFR part 426.
As discussed previously, we believe an administratively more
efficient process is needed for local coverage determinations for
clinical diagnostic laboratory testing. If we continue to require that
MACs follow all steps in the current LCD process, we fear that LCDs
will not be able to be finalized quickly enough for even a fraction of
the thousands of new clinical diagnostic (particularly molecular) tests
developed each year.
We believe this proposed new process for clinical diagnostic
laboratory tests will allow for public dialogue, notification of
stakeholders, and expedited beneficiary access to covered tests. Table
18 summarizes the differences between the current LCD process and the
proposed new LCD process for the development of clinical diagnostic
laboratory testing policies.
Table 18--Comparison of Current LCD Process Versus Proposed LCD Process
for Clinical Diagnostic Laboratory Tests
------------------------------------------------------------------------
Proposed LCD process for
Current LCD process clinical diagnostic laboratory
tests
------------------------------------------------------------------------
Issue Draft LCD in Medicare Coverage Issue Draft LCD in Medicare
Database, which identifies criteria Coverage Database, which
used for determining coverage under identifies criteria used for
statutory ``reasonable and necessary'' determining coverage under
standard. statutory ``reasonable and
necessary'' standard.
Public comment period of 45 calendar Public comment period of 30
days. calendar days with option to
extend.
Present LCD at CAC & discussion at open Optional CAC meeting. No
stakeholder meetings. requirement for open
stakeholder meeting.
Publication of Comment/Response Publication of Comment/Response
Document and final LCD (no specified Document and final LCD within
time of publication after the close of 45 calendar days of the close
the comment period). of the draft LCD comment
period.
Notice period of 45 calendar days with Final LCD effective on the date
the final LCD effective the 46th of publication.
calendar day.
Interested parties may request Interested parties may request
reconsideration of an LCD. reconsideration of an LCD.
An aggrieved party may further An aggrieved party may further
challenge an LCD. challenge an LCD.
------------------------------------------------------------------------
In summary, we believe this proposed process would meet all the
requirements of the PAMA, would be open and transparent, would allow
for public input, and would be administratively efficient. We are
proposing this process only for clinical diagnostic laboratory testing
when coverage policies are developed by a MAC through an LCD; it would
not apply to the NCD process or other vehicles of coverage including
claim-by-claim adjudication. We believe the proposed process would
balance stakeholders' concerns about ensuring an open and transparent
process with the ability to efficiently review clinical laboratory
tests for coverage. We encourage public comment on all aspects of this
proposed process.
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-
[[Page 40381]]
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 focus 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 propose 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 propose 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 propose that the
cross reference to Sec. 405.803 in Sec. 405.450(a) be replaced with a
cross reference to Sec. 498.3(b). We also propose 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 propose 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 propose 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.''
[[Page 40382]]
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 [contractor] 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 providing services in place of the
departed physician in the departed physician's former medical group,
while the departed physician is also providing 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 contractor 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 contractor upon
request. (See Medicare Claims Processing Manual (Pub. 100-4), Chapter
1, Sections 30.2.10 and 30.2.11) However, having a NPI or UPIN does not
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 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 are seeking 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. Solicitation 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 are soliciting
comments on the policy for substitute physician billing arrangements.
We note that any regulations would be proposed in a future rulemaking
with opportunity for public comment. Through this solicitation, we hope
to understand better current industry practices with respect to 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. Therefore,
[[Page 40383]]
we are soliciting comments on the following:
(1) How physicians and other entities are currently utilizing the
services of substitute physicians and billing for such services. We are
interested in specific examples, including the circumstances that give
rise to the need for the substitute physician, the types of services
furnished by the substitute physician, the billing for the services of
the substitute physician, the length of time that the substitute
physician's services are needed or used, and any other information
relevant to the substitute physician billing arrangement.
(2) When a physician is ``unavailable'' to provide services for
purposes of section 1842(b)(6)(D) of the Act. We are particularly
interested in comments from physicians, medical groups and other
entities that utilize the services of substitute physicians regarding
when a regular physician is ``unavailable.''
(3) Whether we should limit substitute physician billing
arrangements to those ``between the two physicians'' (rather than
between a medical group, employer or other entity and the substitute
physician) as stated in section 1842(b)(6)(D)(ii) of the Act.
(4) Whether we should permit the sequential use of multiple
substitute physicians provided that each substitute physician furnishes
services for the unavailable physician for no more than 60 continuous
days.
(5) Whether we should have identical or different criteria for
substitute physician billing arrangements under sections
1842(b)(6)(D)(ii)(I) and (II) of the Act; that is, whether we should
treat reciprocal substitute physician billing arrangements differently
than paid (or locum tenens) substitute physician billing arrangements.
(6) Whether substitute physicians furnishing services to Medicare
beneficiaries should be required to enroll in the Medicare program.
(7) Whether entities submitting claims for services furnished by
substitute physicians should include on the CMS-1500 claim form or on
the appropriate electronic claim the identity of the substitute
physician and, if so, whether the CMS-1500 claim form or the
appropriate electronic claim should be revised to accommodate such a
requirement.
(8) Whether we should place limitations on the use of the
substitute physician and billing for his or her services (for example,
limits on the length of time that an individual substitute physician
may provide services to replace a particular departed physician; limits
on the overall length of time that substitute physicians may provide
services to replace a particular departed physician; a requirement that
the departing physician be a party to the substitute physician billing
arrangement; or permitting the use of a substitute physician only where
a demonstrated staffing need can be shown). We are also seeking
comments regarding whether these limitations should be different
depending on the circumstances underlying or requiring the use of the
substitute physician.
(9) Whether we should limit or prohibit the use of substitute
physician billing arrangements in certain programs or for certain
purposes (for example, the Medicare Shared Savings Program or
determining whether a physician is a member of a group practice for
purposes of the physician self-referral law).
(10) The impact of substitute physician billing arrangements on CMS
programs that rely on the Provider Enrollment, Chain and Ownership
System (PECOS) (for example, the Medicare Shared Savings Program),
enforcement of the physician self-referral law, and program integrity
oversight.
(11) Additional program integrity safeguards that should be
included in our substitute physician billing policy to protect against
program and patient abuse. These could include, but are not limited to,
qualifications for substitute physicians related to exclusion status,
quality of care, or licensure and certifications.
(12) Any other issues that we should consider in determining
whether to propose regulations interpreting section 1842(b)(6)(D) of
the Act.
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 to
the 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 (Sunshine Act)''
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 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 are proposing 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 are proposing 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 propose 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 propose 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.
[[Page 40384]]
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
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 propose 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, 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 seek comments on both alternatives presented, including
commenters' suggestions about what standards, if any, CMS should
incorporate.
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 making 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 propose to revise Sec. 403.904(c)(8) to require
applicable manufacturers to report the marketed name for all covered
and non-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.
Section 403.904(d)(3) requires the reporting of stock, stock option
or any other ownership interest. We are proposing 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 seek 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.
[[Page 40385]]
4. Summary of Proposed Changes
As noted above in this section, we propose the following changes to
Part 403, subpart I:
Deleting the definition of ``covered device'' at Sec.
403.902.
Deleting Sec. 403.904(g) and redesignating the remaining
paragraphs in that section.
Revising Sec. 403.904(c)(8) to require the reporting of
the marketed name of the related covered and non-covered drugs,
devices, biologicals, or medical supplies, unless the payment or other
transfer of value is not related to a particular covered or non-covered
drug, device, biological or medical supply.
Revising Sec. 403.904(d) to require the reporting of the
reporting of stock, stock option or any other options as distinct
categories.
Data collection requirements would begin January 1, 2015 according
to this proposed rule for applicable manufacturers and applicable group
purchasing organizations.
J. Physician Compare Web site
1. Background and Statutory Authority
Section 10331(a)(1) of the Affordable Care Act, required 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 required 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 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 when selecting quality measures for
Physician Compare. We also continue to get input from stakeholders
through a variety of means including rulemaking and different forms of
stakeholder outreach (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
[[Page 40386]]
function--and considerably improving Web site functionality and
usability. 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.
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 the 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 propose 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).
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 participating in the Group Practice
Reporting Option (GPRO) under the 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 propose 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).
As we finalized in the 2014 PFS final rule with comment period (78
FR 74450), we will publicly report the names of those EPs who report
the 2014 PQRS Cardiovascular Prevention measures group in support of
the Million Hearts Initiative on Physician Compare in 2015 by including
a check mark in the quality programs section of the profile page. We
propose 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). 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).
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.\5\ 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 late 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.
---------------------------------------------------------------------------
\5\ 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, CMS 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 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, CMS can
investigate the extent to which each quality measure is correlated with
related, previously validated, measures. CMS 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
[[Page 40387]]
measure are computed using contemporaneous data. In this context, the
previously validated measure should measure a health outcome related to
the outcome of interest.
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 69166-69167), 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 are 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.\7\
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 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) are
available for public reporting in 2015.
For 2014, we also finalized publicly reporting 2014 PQRS measure
data 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 through 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 19 for a summary of our final
policies for public reporting data on Physician Compare.
Table 19--Summary of Previously Finalized Policies for Public Reporting on Physician Compare
----------------------------------------------------------------------------------------------------------------
Quality measures and data
Data collection year Public reporting year Reporting mechanism(s) for public reporting
----------------------------------------------------------------------------------------------------------------
2012.............................. 2013................... Web Interface (WI), Include an indicator for
EHR, Registry, Claims. satisfactory reporters
under PQRS and PQRS GPRO,
successful e-prescribers
under eRx, and
participants in EHR for
groups and individuals as
applicable.
2012.............................. 2014................... WI.................... 5 Diabetes Mellitus (DM)
and Coronary Artery
Disease (CAD) measures
collected via the WI for
group practices with a
minimum sample size of 25
patients and Shared
Savings Program ACOs.
[[Page 40388]]
2013.............................. 2014................... WI, EHR, Registry, Include an indicator for
Claims. satisfactory reporters
under PQRS and PQRS GPRO,
successful e-prescribers
under eRx, and
participants in EHR, as
well as for EPs who earn a
Maintenance of
Certification (MOC)
Incentive and EPs who
report the PQRS
Cardiovascular
Prevention measures group
in support of Million
Hearts.
2013.............................. Expected to be December WI.................... Up to 6 DM and 2 CAD
2014. measures collected via the
WI for groups of 25 or
more EPs with a minimum
sample size of 20
patients.
Will include composites for
DM and CAD, if feasible.
2013.............................. Expected to be December WI.................... 5 CG-CAHPS summary measures
2014. for groups of 100 or more
EPs reporting via the WI
and 6 ACO CAHPS summary
measures for Shared
Savings Program ACOs.
2014.............................. Expected to be 2015.... WI, EHR, Registry, Include an indicator for
Claims. satisfactory reporters
under PQRS and PQRS GPRO,
participants in EHR, as
well as for EPs who earn a
Maintenance of
Certification (MOC)
Incentive and EPs who
report the PQRS
Cardiovascular
Prevention measures group
in support of Million
Hearts.
2014.............................. Expected to be late WI, EHR, Registry..... All measures reported via
2015. the GPRO WI, 13 EHR, and
16 Registry GPRO measures
are also available for
group practices of 2 or
more EPs and Shared
Savings Program ACOs with
a minimum sample size of
20 patients.
Include composites for DM
and CAD, if feasible.
2014.............................. Expected to be late WI, Certified Survey Up to 12 CG-CAHPS summary
2015. Vendor. measures for groups of 100
or more EPs reporting via
the WI and group practices
of 25 to 99 EPs reporting
via a CMS-approved
certified survey vendor,
as well as 6 ACO CAHPS
summary measures for
Shared Savings Program
ACOs reporting through the
GPRO web interface or
other CMS-approved tool or
interface.
2014.............................. Expected to be late Registry, EHR, or A sub-set of 20 PQRS
2015. Claims. measures submitted by
individual EPs that align
with those available for
group reporting via the WI
that are collected through
a Registry, EHR, or claims
with a minimum sample size
of 20 patients.
2014.............................. Expected to be late Registry, EHR, or Measures from the
2015. Claims. Cardiovascular Prevention
measures group reported by
individual EPs in support
of the Million Hearts
Initiative with a minimum
sample size of 20
patients.
----------------------------------------------------------------------------------------------------------------
3. Proposals for Public Data Disclosure on Physician Compare in 2015
and 2016
We are continuing the expansion of public reporting on Physician
Compare by proposing to make 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 are now proposing to increase
the measures available for public reporting.
We previously finalized in the CY 2014 PFS final rule with comment
period (78 FR 74450) to make available for public reporting all PQRS
GPRO measures collected in 2014 via the web interface. We now propose
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.\6\ Similarly, all measures reported
by Shared Savings Program ACOs would be
[[Page 40389]]
available for public reporting on Physician Compare. As with all
quality measures proposed for inclusion on Physician Compare, only
measures that prove to be valid, reliable, and accurate upon analysis
and review at the conclusion of data collection will be included on the
Web site. Also, we propose that measures must meet the public reporting
criteria of a minimum sample size of 20 patients. We propose to include
an indicator of which reporting mechanism was used and only measures
deemed statistically comparable would be included on the site.\7\ We
propose to publicly report all measures submitted and reviewed and
found to be statistically valid and reliable in the Physician Compare
downloadable file. However, we propose that not all of these measures
necessarily would be included on the Physician Compare profile pages.
Consumer testing has shown including too much information and/or
measures that are not well understood by consumers on these pages can
negatively impact a consumer's ability to make informed decisions. Our
analysis of the measure data once collected, consumer testing, and
stakeholder feedback would 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. And, 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. As 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.
---------------------------------------------------------------------------
\6\ 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.
\7\ 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.
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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.
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.
In addition to making all 2015 PQRS GPRO measures available for
public reporting, we seek comment 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 will
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
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. We have received ample
feedback from stakeholders indicating such scores are strongly desired.
Composite scores, generally, have also proven to be critical for
providing consumers a better way to understand quality measure data as
composites provide a more concise, easy to understand picture of
physician quality. Therefore, we plan to analyze the data once
collected to establish the best possible composite, which would help
consumers use these quality data to make informed health care
decisions.
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 propose 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 propose to follow this methodology
using the 2014 PQRS GPRO data, however.
As outlined for the Shared Savings Program, we propose 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 points systems 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
[[Page 40390]]
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.
Understanding the value consumers place on patient experience data
and the commitment to reporting these data on Physician Compare, we
propose publicly reporting in CY 2016 patient experience data from 2015
for all group practices of 2 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 propose to publicly report for
2015 data on Physician Compare in 2016 the 12 summary survey measures
previously finalized for 2014 data:
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 propose 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 propose 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 previously finalized in the 2014 PFS final rule with comment
period (78 FR 74454) that 20 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 propose to expand
on this in two ways. First, we propose to publicly report these same 20
measures for 2013 PQRS data in early 2015. Publicly reporting these
2013 individual measures will help ensure individual level measures are
made available as soon as possible. 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.
Second, we propose 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.\8\ This will provide the
opportunity for more EPs to have measures included on Physician
Compare, and it will provide more information to consumers to make
informed decisions about their health care. As with group-level
measures, we propose 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
measure data once collected, consumer testing, and stakeholder feedback
would determine specifically which measures are published on profile
pages on the Web site. In this way, quality information at the
individual practitioner level would be available, as has been regularly
requested by Medicare consumers, but consumers will not be overwhelmed
with too much information on each EPs profile page.
---------------------------------------------------------------------------
\8\ 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.
---------------------------------------------------------------------------
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 seek
comment to create composites and publish composite scores by grouping
measures based on the PQRS measure groups, if technically feasible. We
will 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)
General Surgery (see Table 33)
Oncology (see Table 38)
Preventive Care (see Table 41)
Rheumatoid Arthritis (RA) (see Table 42)
Total Knee Replacement (TKR) (see Table 45)
We would analyze the component measures that make up each of these
measure groups to see if a statistically viable composite can be
constructed with the data reported for 2015. In addition, we propose to
use the same methodology outlined above for group practices to develop
benchmarks for individual practitioners. As noted for group practices,
we believe that providing composite scores and benchmarks will give
consumers the tools needed to most accurately interpret the quality
data published on Physician Compare.
Previously, we indicated an interest in including specialty society
measures on Physician Compare. We now seek comment on posting these
measures on the Web site. We also seek comment on the option of linking
from Physician Compare to specialty society Web sites that publish non-
PQRS measures. Including specialty society measures on the site or
linking to specific specialty society measures would provide the
opportunity for more eligible professionals to have measures included
on Physician Compare and thus help Medicare consumers make more
informed choices. The quality measures developed by specialty societies
that would be considered for future posting on Physician Compare are
those that have been comprehensively vetted and tested, and are trusted
by the physician community. These measures would provide access to
available specialty specific quality measures that are often highly
regarded and trusted by the stakeholder community and, most
importantly, by the specialties they represent. We are working to
identify possible societies to reach out to, and seek comment on the
concept, as well as potential specific society measures of interest.
Finally, we propose to make available on Physician Compare, 2015
Qualified Clinical Data Registry (QCDR) measure data collected at the
individual level or aggregated to a higher level of the QCDR's
choosing--such as the group practice level, if technically feasible.
QCDRs are able to collect both PQRS
[[Page 40391]]
measures and non-PQRS measures.\9\ We believe that making QCDR data
available on Physician Compare further supports the expansion of
quality measure data available for EPs and group practices regardless
of specialty therefore providing more quality data to consumers to help
them make informed decisions. The QCDR would be required to declare
during their self-nomination if they plan to post data on their own Web
site and allow Physician Compare to link to it or if they will provide
data to us for public reporting on Physician Compare. We propose that
measures collected via QCDRs must also meet the established public
reporting criteria, including a 20 patient minimum sample size. As with
PQRS data, we propose 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
measure data once collected, consumer testing, and stakeholder feedback
would determine specifically which measures are published on profile
pages on the Web site.
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\9\ http://www.cms.gov/apps/ama/license.asp?file=/PQRS/downloads/2014_PQRS_IndClaimsRegistry_MeasureSpecs_SupportingDocs_12132013.zip.
---------------------------------------------------------------------------
Table 20 summarizes the Physician Compare proposals detailed in
this section. We solicit comments on all proposals. Increasing the
measures available for public reporting on Physician Compare at both
the individual and group level will help accomplish the Web site's
twofold purpose:
Provide more information for consumers to encourage
informed patient choice.
Create explicit incentives for physicians to maximize
performance.
Table 20--Summary of Proposed Data for Public Reporting
----------------------------------------------------------------------------------------------------------------
Proposed quality measures
Data collection year Publication Data type Reporting mechanism and data for public
year reporting
----------------------------------------------------------------------------------------------------------------
2013..................... 2015 PQRS................ Registry, EHR, or Twenty 2013 PQRS
Claims. individual measures
collected through a
Registry, EHR, or claims
mirroring the measures
finalized for 2014 (78
FR 74454).
2015..................... 2016 Multiple............ Web Interface, EHR, Include an indicator for
Registry, Claims. satisfactory reporters
under PQRS and PQRS
GPRO, participants in
EHR, and EPs who report
the PQRS Cardiovascular
Prevention measures
group in support of
Million Hearts.
2015..................... 2016 PQRS GPRO & ACO GPRO Web Interface, EHR, All 2015 PQRS GPRO
& Registry. measures reported via
the Web Interface, EHR,
and Registry are
available for public
reporting for group
practices of 2 or more
EPs and all measures
reported by ACOs with a
minimum sample size of
20 patients.
2015..................... 2016 CAHPS for PQRS & CMS-Specified 2015 CAHPS for PQRS for
CAHPS for ACOs. Certified CAHPS groups of 2 or more EPs
Vendor. and CAHPS for ACOs for
those who meet the
specified sample size
requirements and collect
data via a CMS-specified
certified CAHPS vendor.
2015..................... 2016 PQRS................ Registry, EHR, or All 2015 PQRS measures
Claims. for individual EPs
collected through a
Registry, EHR, or
claims.
2015..................... 2016 QCDR data........... QCDR................ All 2015 QCDR data
available for public
report on Physician
Compare at the
individual level or
aggregated to a higher
level of the QCDR's
choosing.
----------------------------------------------------------------------------------------------------------------
K. Physician Payment, Efficiency, and Quality Improvements--Physician
Quality Reporting System
This section contains the proposed requirements for the Physician
Quality Reporting System (PQRS). The PQRS, as set forth in sections
1848(a), (k), and (m) of the Act, is a quality reporting program that
provides incentive payments (ending with 2014) and payment adjustments
(beginning in 2015) to eligible professionals and group practices based
on whether they satisfactorily report data on quality measures for
covered professional services furnished during a specified reporting
period or to individual eligible professionals that satisfactorily
participate in a qualified clinical data registry (QCDR).
The proposed requirements will primarily focus on our proposals
related to the 2017 PQRS payment adjustment, which will be based on an
eligible professional's or a group practice's reporting of quality
measures data during the 12-month calendar year reporting period
occurring in 2015 (that is, January 1 through December 31, 2015).
Please note that, in developing these proposals, we focused on aligning
our requirements with other quality reporting programs, such as the
Medicare EHR Incentive Program for Eligible Professionals, the
Physician Value-Based Payment Modifier (VM), and the Medicare Shared
Savings Program, where and to the extent appropriate and feasible. In
previous years, we have made various strides in our ongoing efforts to
align the reporting requirements in CMS' various quality reporting
programs to reduce burden on the eligible professionals and group
practices that participate in these programs. Particularly through the
QCDR option, we are exploring opportunities to align with quality
reporting programs that exist outside of CMS where and to the extent
appropriate and feasible. We continued to focus on alignment as we
developed our proposals for the 2017 PQRS payment adjustment below.
The PQRS regulation is located at 42 CFR 414.90. The program
requirements for the 2007 through 2014 PQRS incentives and the 2015 and
2016 PQRS payment adjustment that were previously established, as well
as
[[Page 40392]]
information on the PQRS, including related laws and established
requirements, are available at http://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/PQRS/index.html. In
addition, the 2012 PQRS and eRx Experience Report, which provides
information about eligible professional participation in PQRS, is
available for download at http://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/PQRS/Downloads/2012-PQRS-and-eRx-Experience-Report.zip.
We note that eligible professionals in critical access hospitals
(CAHs) were previously not able to participate in the PQRS. Due to a
change we made in the manner in which eligible professionals in CAHs
are reimbursed by Medicare, it is now feasible for eligible
professionals in CAHs to participate in the PQRS. Although eligible
professionals in CAHs are not able to use the claims-based reporting
mechanism to report PQRS quality measures data in 2014, beginning in
2015, these eligible professionals in CAHs may participate in the PQRS
using ALL reporting mechanisms available, including the claims-based
reporting mechanism. Finally, please note that in accordance with
section 1848(a)(8) of the Act, all eligible professionals who do not
meet the criteria for satisfactory reporting or satisfactory
participation for the 2017 PQRS payment adjustment will be subject to
the 2017 PQRS payment adjustment with no exceptions.
In addition, in the CY 2013 PFS final rule with comment period, we
introduced the reporting of the Agency for Healthcare Research and
Quality's (AHRQ's) Clinician & Group (CG) Consumer Assessment of
Healthcare Providers and Systems (CAHPS) survey measures, referenced at
https://cahps.ahrq.gov/Surveys-Guidance/CG/index.html. AHRQ's CAHPS
Clinician & Group Survey Version 2.0 (CG-CAHPS) includes 34 core CG-
CAHPS survey questions. In addition to these 34 core questions, the
CAHPS survey measures that are used in the PQRS include supplemental
questions from CAHPS Patient-Centered Medical Home Survey, Core CAHPS
Health Plan Survey Version 5.0, other CAHPS supplemental items, and
some additional questions. Since the CAHPS survey used in the PQRS
covers more than just the 34 core CG-CAHPS survey measures, we will
refer to the CG-CAHPS survey measures used in the PQRS as ``CAHPS for
PQRS.'' We propose to make this revision throughout Sec. 414.90.
1. Requirements for the PQRS Reporting Mechanisms
The PQRS includes the following reporting mechanisms: Claims;
qualified registry; EHR (including direct EHR products and EHR data
submission vendor products); the Group Practice Reporting Option (GPRO)
web interface; certified survey vendors, for CG-CAHPS survey measures;
and the QCDR. Under the existing PQRS regulation, Sec. 414.90(h)
through (k) govern which reporting mechanisms are available for use by
individuals and group practices for the PQRS incentive and payment
adjustment. This section III.K.1 contains our proposals to change the
qualified registry, direct EHR and EHR data submission vendor products,
QCDR, and GPRO web interface reporting mechanisms. Please note that we
are not proposing to make changes to the claims-based reporting
mechanism.
a. Proposed Changes to the Requirements for the Qualified Registry
In the CY 2013 and 2014 PFS final rules with comment period, we
established certain requirements for entities to become qualified
registries for the purpose of verifying that a qualified registry is
prepared to submit data on PQRS quality measures for the reporting
period in which the qualified registry seeks to be qualified (77 FR
69179 through 69180 and 78 FR 74456). Specifically, in the CY 2014 PFS
final rule with comment period, in accordance with the satisfactory
reporting criterion we finalized for individual eligible professionals
or group practices reporting PQRS quality measures via qualified
registry, we finalized the following requirement that a qualified
registry must be able to collect all needed data elements and transmit
to CMS the data at the TIN/NPI level for at least 9 measures covering
at least 3 of the National Quality Strategy (NQS) domains (78 FR
74456).
As we explain in further detail in this section III.K, we are
proposing that--in addition to proposing to require that an eligible
professional or group practice report on at least 9 measures covering 3
NQS domains--an eligible professional or group practice who sees at
least 1 Medicare patient in a face-to-face encounter, as we propose to
define that term in section III.K.2.a., and wishes to meet the proposed
criterion for satisfactory reporting of PQRS quality measures via a
qualified registry for the 2017 PQRS payment adjustment would be
required to report on at least 2 cross-cutting PQRS measures specified
in Table 21. In accordance with this proposal, we are proposing to
require that, in addition to being required to be able to collect all
needed data elements and transmit to CMS the data at the TIN/NPI level
for at least 9 measures covering at least 3 of the NQS domains for
which a qualified registry transmits data, a qualified registry would
be required to be able to collect all needed data elements and transmit
to CMS the data at the TIN/NPI level for ALL cross-cutting measures
specified in Table 21 for which the registry's participating eligible
professionals are able to report. We are proposing to require that
qualified registries be able to report on all cross-cutting measures
specified in Table 21 for which the registry's participating eligible
professionals are able to report, rather than proposing to require a
minimum of 2, so that eligible professionals and group practices using
qualified registries to report PQRS measures would have the flexibility
in choosing which cross-cutting measures to report, and to report on as
many cross-cutting measures specified in Table 21 as they are able.
Furthermore, in the CY 2013 PFS final rule, we noted that qualified
registries have until the last Friday of February following the
applicable reporting period (for example, February 28, 2014, for
reporting periods ending in 2013) to submit quality measures data on
behalf of its eligible professionals (77 FR 69182). We continue to
receive stakeholder feedback, particularly from qualified registries
currently participating in the PQRS, urging us to extend this
submission deadline due to the time it takes for these qualified
registries to collect and analyze the quality measures data received
after the end of the reporting period. While, at the time, we
emphasized the need to have quality measures data received by CMS no
later than the last Friday of the February occurring after the end of
the applicable reporting period, we believe it is now feasible to
extend this deadline. Therefore, we propose to extend the deadline for
qualified registries to submit quality measures data, including, but
not limited to, calculations and results, to March 31 following the end
of the applicable reporting period (for example, March 31, 2016, for
reporting periods ending in 2015).
In addition, we seek comment on whether to propose in future
rulemaking to allow more frequent submissions of data, such as
quarterly or year-round submissions, rather than having only one
opportunity to submit quality measures data as is our current process.
We invite public comment on these proposals.
[[Page 40393]]
b. Proposed Changes to the Requirements for the Direct EHR and EHR Data
Submission Vendor Products That Are CEHRT
In the CY 2013 PFS final rule with comment period, we finalized
requirements that although EHR vendors and their products would no
longer be required to undergo the previously existing qualification
process, we would only accept the data if the data are: (1) Transmitted
in a CMS-approved XML format utilizing a Clinical Document Architecture
(CDA) standard such as Quality Reporting Data Architecture (QRDA) level
1 (and for EHR data submission vendor products that intend to report
for purposes of the proposed PQRS-Medicare EHR Incentive Program Pilot,
if the aggregate data are transmitted in a CMS-approved XML format);
and (2) in compliance with a CMS-specified secure method for data
submission (77 FR 69183 through 69187). To further clarify, EHR vendors
and their products must be able to submit data in the form and manner
specified by CMS. Accordingly, direct EHRs and EHR data submission
vendors must comply with CMS Implementation Guides for both the QRDA-I
and QRDA-III data file formats. The Implementation Guides for 2014 are
available at http://www.cms.gov/Regulations-and-Guidance/Legislation/EHRIncentivePrograms/Downloads/Guide_QRDA_2014eCQM.pdf. Updated
guides for 2015, when available, will be posted on the CMS EHR
Incentive Program Web site at http://www.cms.gov/Regulations-and-Guidance/Legislation/EHRIncentivePrograms. These implementation guides
further describe the technical requirements for data submission to
ensure the data elements required for measure calculation and
verification are provided. We propose to continue applying these
requirements to direct EHR products and EHR data submission vendor
products for 2015 and beyond. For 2015 and beyond, we also propose to
have the eligible professional or group practice provide the CMS EHR
Certification Number of the product used by the eligible professional
or group practice for direct EHRs and EHR data submission vendors.
We believe this requirement is necessary to ensure that the
eligible professionals and group practices that are using EHR
technology are using a product that is certified EHR technology (CEHRT)
and will allow CMS to ensure that the eligible professional or group
practice's data is derived from a product that is CEHRT.
Additionally, we seek comment on whether to propose in future
rulemaking to allow more frequent submissions of data, such as
quarterly or year-round submissions, rather than having only one
opportunity to submit quality measures data as is our current process.
We invite public comment on these proposals.
c. Proposed Changes to the Requirements for the QCDR
In the CY 2014 PFS final rule with comment period, we established
certain requirements for entities to become QCDRs for the purpose of
having their participating eligible professionals meet the criteria for
satisfactory participation in a QCDR for purposes of the PQRS
incentives and payment adjustments (78 FR 74465 through 74474).
Specifically, in accordance with the final criterion that required
eligible professionals to report on at least 1 outcome measure, we
required that an entity possess at least 1 outcome measure for which
its participating eligible professionals may report (78 FR 74470). As
we explain in further detail in section III.K. of this proposed rule,
we are proposing that an eligible professional wishing to meet the
proposed criterion for satisfactory participation in a QCDR for the
2017 PQRS payment adjustment report on at least 3 outcome measures (or
if less than 3 outcome measures are available for reporting, report on
at least 2 outcome measures and at least 1 of the following types of
measures: resource use; patient experience of care; or efficiency/
appropriate use). Accordingly, we are proposing to amend the
requirement for the 2017 PQRS payment adjustment to require a QCDR to
possess at least 3 outcome measures (or, in lieu of 3 outcome measures,
at least 2 outcome measures and at least 1 of the following other types
of measures--resource use, patient experience of care, or efficiency/
appropriate use).
To establish the minimum number of measures (9 measures covering at
least 3 NQS domains) a QCDR may report for the PQRS, we placed a limit
on the number of non-PQRS measures (20) that a QCDR may submit on
behalf of an eligible professional at this time (78 FR 74476). Although
we believe such a limit is still necessary because the QCDR option is
still new and we are still gaining familiarity with the measures
available for reporting under the QCDRs, we believe it is appropriate
to increase the number of non-PQRS that may be reported by QCDRs. We
have received comments from entities currently undergoing the QCDR
qualification process who wish to submit data on additional measures
and we believe that accepting additional quality measures data is
important, as it provides a better and more complete picture of the
quality of care provided by eligible professionals. Therefore, we are
proposing to change this limit from 20 measures to 30. In other words,
beginning with the criteria for satisfactory participation for the 2017
PQRS payment adjustment, a QCDR may submit quality measures data for a
maximum of 30 non-PQRS measures. Please note that this proposed limit
does not apply to measures contained in the PQRS measure set, as QCDRs
can report on as many measures in the PQRS measure set as they wish.
Additionally, CMS' experience during the 2014 self-nomination
process shed light on clarifications needed on what is considered a
non-PQRS measure. Therefore, to clarify the definition of non-PQRS
measures, we propose the following parameters for a measure to be
considered a non-PQRS measure:
A measure that is not contained in the PQRS measure set
for the applicable reporting period.
A measure that may be in the PQRS measure set but has
substantive differences in the manner it is reported by the QCDR. For
example, PQRS measure 319 is reportable only via the GPRO web
interface. A QCDR wishes to report this measure on behalf of its
eligible professionals. However, as CMS has only extracted the data
collected from this quality measure using the GPRO web interface, in
which CMS utilizes a claims-based assignment and sampling methodology
to inform the groups on which patients they are to report, the
reporting of this measure would require changes to the way that the
measure is calculated and reported to CMS via a QCDR instead of through
the GPRO web interface. Therefore, due to the substantive changes
needed to report this measure via a QCDR, PQRS measure 319 would be
considered a non-PQRS measure. In addition, CAHPS for PQRS is currently
reportable only via a CMS-certified survey vendor. However, although
CAHPS for PQRS is technically contained in the PQRS measure set, we
consider the changes that will need to be made to be available for
reporting by individual eligible professionals (and not as a part of a
group practice) significant enough as to treat CAHPS for PQRS as a non-
PQRS measure for purposes of reporting CAHPS for PQRS via a QCDR.
Furthermore, under our authority to establish the requirements for
an entity to be considered a QCDR under section 1848(m)(3)(E)(i) of the
Act, we established certain requirements for an
[[Page 40394]]
entity to be considered a QCDR in the CY 2014 PFS final rule with
comment period (78 FR 74467 through 74473). Under this same authority,
we are proposing here to add the following requirement that an entity
must meet to serve as a QCDR under the PQRS for reporting periods
beginning in 2015:
Require that the entity make available to the public the
quality measures data for which its eligible professionals report.
In the CY 2014 PFS proposed rule, we proposed that, to be
considered a QCDR, an entity would be required to demonstrate that it
has a plan to publicly report its quality data through a mechanism
where the public and registry participants can view data about
individual eligible professionals, as well as view regional and
national benchmarks (78 FR 43363). Due to stakeholder feedback against
this proposal, as well as comments requesting more details surrounding
this proposal, we did not finalize this proposed requirement in the CY
2014 PFS final rule with comment period. However, we noted that we
would revisit this proposal in future years (78 FR 74471). Because of
our ongoing interest in providing transparency to the public for
quality measures data that is reported under the PQRS, we again propose
the requirement that an entity make available to the public the quality
measures data for which its eligible professionals report. To clarify
this proposal, we propose that, at a minimum, the QCDR publicly report
the following quality measures data information that we believe will
give patients adequate information on the care provided by an eligible
professional:
The title and description of the measures that a QCDR
reports for purposes of the PQRS, as well as the performance results
for each measure the QCDR reports.
With respect to when the quality measures data must be publicly
reported, we propose that the QCDR must have the quality measures data
by April 31 of the year following the applicable reporting period (that
is, April 31, 2016, for reporting periods occurring in 2015). The
proposed deadline of April 31 will provide QCDRs with one month to post
quality measures data and information following the March 31 deadline
for the QCDRs to transmit quality measures data for purposes of the
PQRS payment adjustments. We also propose that this data be available
on a continuous basis and be continuously updated as the measures
undergo changes in measure title and description, as well as when new
performance results are calculated.
Please note that, in making this proposal, we defer to the entity
in terms of the method it will use to publicly report the quality
measures data it collects for the PQRS. For example, to meet this
proposed requirement, it would be sufficient for a QCDR to publicly
report performance rates of eligible professionals through means such
as, but not excluding, board or specialty Web sites, performance or
feedback reports, or listserv dashboards or announcements. We also note
that a QCDR would meet this public reporting requirement if the QCDR's
measures data were posted on Physician Compare. In addition, we defer
to the QCDR to determine whether to report performance results at the
individual eligible professional level or aggregate the results for
certain sets of eligible professionals who are in the same practice
together (but we are not registered as a group practice for the
purposes of PQRS reporting). We believe it is appropriate to allow a
QCDR to publicly report performance results at an aggregate level for
certain eligible professionals when those who are in the same practice
contribute to the overall care provided to a patient.
Based on CMS experience with the qualifying entities wishing to
become QCDRs for reporting periods occurring in 2014, we received
feedback from many organizations who expressed concern that the entity
wishing to become a QCDR may not meet the requirements of a QCDR solely
on its own. Therefore, we provide the following proposals beginning in
2015 on situations where an entity may not meet the requirements of a
QCDR solely on its own but, in conjunction with another entity, may be
able to meet the requirements of a QCDR and therefore be eligible for
qualification:
We propose to allow that an entity that uses an external
organization for purposes of data collection, calculation or
transmission may meet the definition of a QCDR so long as the entity
has a signed, written agreement that specifically details the
relationship and responsibilities of the entity with the external
organizations effective as of January 1 the year prior to the year for
which the entity seeks to become a QCDR (for example, January 1, 2014,
to be eligible to participate for purposes of data collected in 2015).
We are adding this proposal because we received questions from entities
wishing to become QCDRs who are engaged in quality improvement
activities but use an external organization for purposes of quality
measures data collection, calculation, and transmission. We believe
that it may be appropriate to classify the entity as a QCDR so long as
the entity meets the definition of a QCDR by the date for which we
require that a QCDR must be in existence (that is, January 1 the year
prior to the year for which the entity seeks to become a QCDR (78 FR
74467)). Entities that have a mere verbal, non-written agreement to
work together to become a QCDR by January 1 the year prior to the year
for which the entity seeks to become a QCDR would not fulfill this
proposed requirement.
In addition, we propose that an entity that has broken off
from a larger organization may be considered to be in existence for the
purposes of QCDR qualification as of the earliest date the larger
organization begins continual existence. We received questions from
entities who used to be part of a larger organization but have recently
become independent from the larger organization as to whether the
entities would meet the requirement established in the CY 2014 PFS
final rule with comment period that the entity be in existence as of
January 1 the year prior to the year for which the entity seeks to
become a QCDR (78 FR 74467). For example, a registry that was
previously a part of a larger medical society as of January 1, 2013,
could have broken off from the medical society and become an
independent registry in 2014. Likewise, a member of a medical society
could create a registry separate from the medical society. As such,
there would be concern as to whether that entity would meet the
requirement of being in existence prior to January 1, 2013, to be
considered for qualification for reporting periods occurring in 2014.
In these examples, for purposes of meeting the requirement that the
entity be in existence as of January 1 the year prior to the year for
which the entity seeks to become a QCDR, we may consider this entity as
being in existence as of the date the larger medical society was in
existence.
In the CY 2014 PFS final rule with comment period, in accordance
with the submission deadline of quality measures data for qualified
registries, we noted a deadline of the last Friday in February
occurring after the end of the applicable reporting period to submit
quality measures data to CMS (78 FR 74471). In accordance with our
proposal to extend this deadline for qualified registries, we propose
to extend the deadline for QCDRs to submit quality measures data
calculations and results by March 31 following the end of the
applicable reporting period (that is, March 31,
[[Page 40395]]
2016, for reporting periods occurring in 2015).
Additionally, we seek comment on whether to propose in future
rulemaking to allow more frequent submissions of data, such as
quarterly or year-round submissions, rather than having only one
opportunity to submit quality measures data as is our current process.
We seek public comment on these proposed changes to the
requirements for the QCDR.
d. Proposed Changes to the GPRO Web Interface
In the CY 2014 PFS final rule with comment period (78 FR 74456), we
finalized our proposal to require ``that group practices register to
participate in the GPRO by September 30 of the year in which the
reporting period occurs (that is September 30, 2014 for reporting
periods occurring in 2014), as proposed.'' However, we noted that, in
order ``to respond to the commenters concerns to provide timelier
feedback on performance on CG CAHPS in the future, we anticipate
proposing an earlier deadline for group practices to register to
participate in the GPRO in future years'' (78 FR 74456). Indeed, to
provide timelier feedback on performance on CAHPS for PQRS, we propose
to modify the deadline that a group practice must register to
participate in the GPRO to June 30 of the year in which the reporting
period occurs (that is, June 30, 2015, for reporting periods occurring
in 2015). Although this proposed GPRO registration deadline would
provide less time for a group practice to decide whether to participate
in the GPRO, we believe the benefit of providing timelier feedback
reports outweighs this concern.
Furthermore, we seek comment on whether to allow more frequent
submissions of data, such as quarterly or year-round submissions,
rather than having only one opportunity to submit quality measures data
as is our current process.
We seek public comment on these proposals.
2. Proposed Criteria for the Satisfactory Reporting for Individual
Eligible Professionals for the 2017 PQRS Payment Adjustment
Section 1848(a)(8) of the Act, as added by section 3002(b) of the
Affordable Care Act, provides that for covered professional services
furnished by an eligible professional during 2015 or any subsequent
year, if the eligible professional does not satisfactorily report data
on quality measures for covered professional services for the quality
reporting period for the year, the fee schedule amount for services
furnished by such professional during the year (including the fee
schedule amount for purposes of determining a payment based on such
amount) shall be equal to the applicable percent of the fee schedule
amount that would otherwise apply to such services. For 2016 and
subsequent years, the applicable percent is 98.0 percent.
a. Proposed Criterion for the Satisfactory Reporting of Individual
Quality Measures via Claims and Registry for Individual Eligible
Professionals for the 2017 PQRS Payment Adjustment
In the CY 2014 PFS final rule with comment period (see Table 47 at
78 FR 74479), we finalized the following criteria for satisfactory
reporting for the submission of individual quality measures via claims
and registry for the 2014 PQRS incentive: For the 12-month reporting
period for the 2014 PQRS incentive, the eligible professional would
report at least 9 measures, covering at least 3 of the NQS domains, OR,
if less than 9 measures apply to the eligible professional, report 1-8
measures, AND report each measure for at least 50 percent of the
Medicare Part B FFS patients seen during the reporting period to which
the measure applies. Measures with a 0 percent performance rate would
not be counted. For an eligible professional who reports fewer than 9
measures covering less than 3 NQS domains via the claims- or registry-
based reporting mechanism, the eligible professional would be subject
to the measure application validity (MAV) process, which would allow us
to determine whether the eligible professional should have reported
quality data codes for additional measures.
To be consistent with the satisfactory reporting criterion we
finalized for the 2014 PQRS incentive, we are proposing to modify Sec.
414.90(j) and propose the following criterion for individual eligible
professionals reporting via claims and registry: For the 12-month
reporting period for the 2017 PQRS payment adjustment, the eligible
professional would report at least 9 measures, covering at least 3 of
the NQS domains AND report each measure for at least 50 percent of the
eligible professional's Medicare Part B FFS patients seen during the
reporting period to which the measure applies. Of the measures
reported, if the eligible professional sees at least 1 Medicare patient
in a face-to-face encounter, as we propose to define that term below,
the eligible professional would report on at least 2 measures contained
in the proposed cross-cutting measure set specified in Table 21. If
less than 9 measures apply to the eligible professional, the eligible
professional would report up to 8 measure(s), AND report each measure
for at least 50 percent of the Medicare Part B FFS patients seen during
the reporting period to which the measure applies. Measures with a 0
percent performance rate would not be counted.
We note that, unlike the criterion we finalized for the 2014 PQRS
incentive, we are proposing to require an eligible professional who
sees at least 1 Medicare patient in a face-to-face encounter, as we
propose to define that term below, during the 12-month 2017 PQRS
payment adjustment reporting period to report at least 2 measures
contained in the proposed cross-cutting measure set specified in Table
21. As we noted in the CY 2014 PFS proposed rule (78 FR 43359), we are
dedicated to collecting data that provides us with a better picture of
the overall quality of care furnished by eligible professionals,
particularly for the purpose of having PQRS reporting being used to
assess quality performance under the VM. We believe that requiring an
eligible professional to report on at least 2 broadly applicable,
cross-cutting measures will provide us with quality data on more varied
aspects of an eligible professional's practice. We also note that in
its 2014 pre-rulemaking final report (available at http://www.qualityforum.org/Publications/2014/01/MAP_Pre-Rulemaking_Report__2014_Recommendations_on_Measures_for_More_than_20_Federal_Programs.aspx), the Measure Applications Partnership (MAP) encouraged
the development of a core measure set (see page 16 of the ``MAP Pre-
Rulemaking Report: 2014 Recommendations on Measures for More than 20
Federal Programs''). The MAP stated ``a core [measure set] would
address critical improvement gaps, align payment incentives across
clinician types, and reduce reporting burden.''
For what defines a ``face-to-face'' encounter, for purposes of
proposing to require reporting of at least 2 cross-cutting measures
specified in Table 21, we propose to determine whether an eligible
professional had a ``face-to-face'' encounter by seeing whether the
eligible professional billed for services under the PFS that are
associated with face-to-face encounters, such as whether an eligible
professional billed general office visit codes, outpatient visits, and
surgical procedures. We would not include telehealth visits as face-to-
face encounters for purposes of the proposals
[[Page 40396]]
require reporting of at least 2 cross-cutting measures specified in
Table 21.
In addition, we understand that there may be instances where an
eligible professional may not have at least 9 measures applicable to an
eligible professional's practice. In this instance, like the criterion
we finalized for the 2014 PQRS incentive (see Table 47 at 78 FR 74479),
an eligible professional reporting on less than 9 measures would still
be able to meet the satisfactory reporting criterion via claims and
registry if the eligible professional reports on 1-8 measures, as
applicable, to the eligible professional's practice. If an eligible
professional reports on 1-8 measures, the eligible professional would
be subject to the MAV process, which would allow us to determine
whether an eligible professional should have reported quality data
codes for additional measures. In addition, the MAV will also allow us
to determine whether a group practice should have reported on any of
the proposed cross-cutting measures specified in Table 21. The MAV
process we are proposing to implement for claims and registry is the
same process that was established for reporting periods occurring in
2014 for the 2014 PQRS incentive. For more information on the claims
MAV process, please visit http://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/PQRS/Downloads/2014_PQRS_Claims_MeasureApplicabilityValidation_12132013.zip. For more
information on the registry MAV process, please visit http://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/PQRS/Downloads/2014_PQRS_Registry_MeasureApplicabilityValidation_12132013.zip.
We seek public comment on our proposed satisfactory reporting
criterion for individual eligible professionals reporting via claims or
registry for the 2017 PQRS payment adjustment.
b. Proposed Criterion for Satisfactory Reporting of Individual Quality
Measures via EHR for Individual Eligible Professionals for the 2017
PQRS Payment Adjustment
In the CY 2013 PFS final rule with comment period, we finalized the
following criterion for the satisfactory reporting for individual
eligible professionals reporting individual measures via a direct EHR
that is CEHRT or an EHR data submission vendor that is CEHRT for the
2014 PQRS incentive: Report 9 measures covering at least 3 of the NQS
domains. If an eligible professional's CEHRT does not contain patient
data for at least 9 measures covering at least 3 domains, then the
eligible professional must report all of the measures for which there
is Medicare patient data. An eligible professional must report on at
least 1 measure for which there is Medicare patient data (see Table 47
at 78 FR 74479).
To be consistent with the criterion we finalized for the 2014 PQRS
incentive, as well as to continue to align with the final criterion for
meeting the clinical quality measure (CQM) component of achieving
meaningful use under the Medicare EHR Incentive Program, we are
proposing to modify Sec. 414.90(j) and propose the following criterion
for the satisfactory reporting for individual eligible professionals to
report individual measures via a direct EHR that is CEHRT or an EHR
data submission vendor that is CEHRT for the 2017 PQRS payment
adjustment: The eligible professional would report 9 measures covering
at least 3 of the NQS domains. If an eligible professional's CEHRT does
not contain patient data for at least 9 measures covering at least 3
domains, then the eligible professional would be required to report all
of the measures for which there is Medicare patient data. An eligible
professional would be required to report on at least 1 measure for
which there is Medicare patient data.
We seek public comment on this proposal.
c. Proposed Criterion for Satisfactory Reporting of Measures Groups via
Registry for Individual Eligible Professionals for the 2017 PQRS
Payment Adjustment
In the CY 2013 PFS final rule with comment period, we finalized the
following criterion for the satisfactory reporting for individual
eligible professionals to report measures groups via registry for the
2014 PQRS incentive: For the 12-month reporting period for the 2014
PQRS incentive, report at least 1 measures group AND report each
measures group for at least 20 patients, the majority (11 patients) of
which must be Medicare Part B FFS patients. Measures groups containing
a measure with a 0 percent performance rate will not be counted (see
Table 47 at 78 FR 74479).
To be consistent with the criterion we finalized for the 2014 PQRS
incentive, we are proposing to modify Sec. 414.90(j) to indicate the
following criterion for the satisfactory reporting for individual
eligible professionals to report measures groups via registry for the
2017 PQRS payment adjustment: For the 12-month reporting period for the
2017 PQRS payment adjustment, the eligible professional would report at
least 1 measures group AND report each measures group for at least 20
patients, the majority (11 patients) of which would be required to be
Medicare Part B FFS patients. Measures groups containing a measure with
a 0 percent performance rate would not be counted.
Although we are proposing satisfactory reporting criterion for
individual eligible professionals to report measures groups via
registry for the 2017 PQRS payment adjustment that is consistent with
criterion finalized for the 2014 PQRS incentive, please note, however,
in this section III.K of this proposed rule, we are proposing to change
the definition of a PQRS measures group.
We seek public comment on our proposed satisfactory reporting
criterion for individual eligible professionals reporting measures
groups via registry for the 2017 PQRS payment adjustment.
3. Satisfactory Participation in a QCDR by Individual Eligible
Professionals
Section 601(b) of the ATRA amended section 1848(m)(3) of the Act,
by redesignating subparagraph (D) as subparagraph (F) and adding new
subparagraphs (D) and (E), to provide for a new standard for individual
eligible professionals to satisfy the PQRS beginning in 2014, based on
satisfactory participation in a QCDR.
a. Proposed Criterion for the Satisfactory Participation for Individual
Eligible Professionals in a QCDR for the 2017 PQRS Payment Adjustment
Section 1848(a)(8) of the Act provides that for covered
professional services furnished by an eligible professional during 2015
or any subsequent year, if the eligible professional does not
satisfactorily report data on quality measures for covered professional
services for the quality reporting period for the year, the fee
schedule amount for services furnished by such professional during the
year shall be equal to the applicable percent of the fee schedule
amount that would otherwise apply to such services. For 2016 and
subsequent years, the applicable percent is 98.0 percent.
Section 1848(m)(3)(D) of the Act, as added by section 601(b) of the
ATRA, authorizes the Secretary to treat an individual eligible
professional as satisfactorily submitting data on quality measures
under section 1848(m)(3)(A) of the Act if, in lieu of reporting
measures under section 1848(k)(2)(C) of the Act, the eligible
professional is satisfactorily participating in a QCDR for the year.
``Satisfactory participation'' is a new standard under the PQRS and
[[Page 40397]]
is a substitute for the underlying standard of ``satisfactory
reporting'' data on covered professional services that eligible
professionals must meet to avoid the PQRS payment adjustment.
Currently, Sec. 414.90(e)(2) states that individual eligible
professionals must be treated as satisfactorily reporting data on
quality measures if the individual eligible professional satisfactorily
participates in a QCDR.
In the CY 2014 PFS final rule with comment period, although we
finalized satisfactory participation criteria for the 2016 PQRS payment
adjustment that are less stringent than the satisfactory participation
criteria we finalized for the 2014 PQRS incentive, we noted that it was
``our intention to fully move towards the reporting of 9 measures
covering at least 3 domains to meet the criteria for satisfactory
participation for the 2017 PQRS payment adjustment'' (78 FR 74477).
Specifically, we finalized the following two criteria for the
satisfactory participation in a QCDR for the 2014 PQRS incentive at
Sec. 414.90(i)(3): For the 12-month 2014 reporting period, report at
least 9 measures available for reporting under the QCDR covering at
least 3 of the NQS domains, and report each measure for at least 50
percent of the eligible professional's applicable patients. Of the
measures reported via a QCDR, the eligible professional must report on
at least 1 outcome measure.
To be consistent with the number of measures reported for the
satisfactory participation criterion we finalized for the 2014 PQRS
incentive, for purposes of the 2017 PQRS payment adjustment (which
would be based on data reported during the 12-month period that falls
in CY 2015), we propose to modify Sec. 414.90(k) to add the following
criteria for individual eligible professionals to satisfactorily
participate in a QCDR for the 2017 PQRS payment adjustment: For the 12-
month reporting period for the 2017 PQRS payment adjustment, the
eligible professional would report at least 9 measures available for
reporting under a QCDR covering at least 3 of the NQS domains, AND
report each measure for at least 50 percent of the eligible
professional's patients. Of these measures, the eligible professional
would report on at least 3 outcome measures, OR, if 3 outcomes measures
are not available, report on at least 2 outcome measures and at least 1
of the following types of measures--resource use, patient experience of
care, or efficiency/appropriate use.
Unlike the satisfactory participation criteria that were
established for the 2014 PQRS incentive, we are proposing to modify
Sec. 414.90(k)(4) to require that an eligible professional report on
not only 1 but at least 3 outcome measures (or, 2 outcome measures and
at least 1 resource use, patient experience of care, or efficiency/
appropriate use if 3 outcomes measures are not available). We are
proposing this increase because it is our goal to, when appropriate,
move towards the reporting of more outcome measures. We believe the
reporting of outcome measures (for example, unplanned hospital
readmission after a procedure) better captures the quality of care an
eligible professional provides than, for example, process measures (for
example, whether a Hemoglobin A1c test was performed for diabetic
patients). In establishing this proposal, we understand that a QCDR may
not have 3 outcomes measures within its quality measure data set.
Therefore, as an alternative to a third outcome measure, we are
allowing an eligible professional to report on at least 1 resource use,
patient experience of care, or efficiency/appropriate use measure in
lieu of an outcome measure.
We seek public comment on these proposals.
4. Proposed Criteria for Satisfactory Reporting for Group Practices
Selected to Participate in the Group Practice Reporting Option (GPRO)
In lieu of reporting measures under section 1848(k)(2)(C) of the
Act, section 1848(m)(3)(C) of the Act provides the Secretary with the
authority to establish and have in place a process under which eligible
professionals in a group practice (as defined by the Secretary) shall
be treated as satisfactorily submitting data on quality measures.
Accordingly, this section III.K.4 contains our proposed satisfactory
reporting criteria for group practices selected to participate in the
GPRO. Please note that, for a group practice to participate in the PQRS
GPRO in lieu of participating as individual eligible professionals, a
group practice is required to register to participate in the PQRS GPRO.
For more information on GPRO participation, please visit http://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/PQRS/Group_Practice_Reporting_Option.html. For more
information on registration, please visit http://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/PhysicianFeedbackProgram/Self-Nomination-Registration.html.
In the CY 2014 PFS final rule with comment period, we established a
deadline of September 30 of the applicable reporting period (that is,
September 30, 2014, for reporting periods occurring in 2014) for a
group practice to register to participate in the GPRO (78 FR 74456).
While we still seek to provide group practices with as much time as
feasible to decide whether to register to participate in the PQRS as a
GPRO, we weigh this priority with others, such as our desire to provide
more timely feedback to participants of the PQRS, as well as other CMS
quality reporting programs such as the VM. Since participation in the
VM is tied to PQRS participation as discussed in section III.N. of this
proposed rule, we have found that having a GPRO registration deadline
so late in time would not allow us to collect information related to
group practice participation in time to provide PQRS and VM
participants with feedback reports earlier in time. Therefore, in an
effort to provide timelier feedback, we are proposing to change the
deadline by which a group practice must register to participate in the
GPRO to June 30 of the applicable 12-month reporting period (that is,
June 30, 2015, for reporting periods occurring in 2015). This proposed
change would allow us to provide timelier feedback while still
providing group practices with over 6 months to determine whether they
should participate in the PQRS GPRO or, in the alternative, participate
in the PQRS as individual eligible professionals. We invite public
comment on this proposal.
a. Proposed Criteria for Satisfactory Reporting on PQRS Quality
Measures Via the GPRO Web Interface for the 2017 PQRS Payment
Adjustment
Consistent with the group practice reporting requirements under
section 1848(m)(3)(C) of the Act, we propose to modify Sec. 414.90(j)
to incorporate the following criterion for the satisfactory reporting
of PQRS quality measures for group practices registered to participate
in the GPRO for the 12-month reporting period for the 2017 PQRS payment
adjustment using the GPRO web interface for groups practices of 25-99
eligible professionals: The group practice would report on all measures
included in the web interface; AND populate data fields for the first
248 consecutively ranked and assigned beneficiaries in the order in
which they appear in the group's sample for each module or preventive
care measure. If the pool of eligible assigned beneficiaries is less
than 248, then the group practice would report on 100 percent of
assigned beneficiaries. In other words, we understand that, in some
instances, the sampling methodology CMS provides will not be able to
assign at least 248 patients on which a group practice may report,
[[Page 40398]]
particularly those group practices on the smaller end of the range of
25-99 eligible professionals. If the group practice is assigned less
than 248 Medicare beneficiaries, then the group practice would report
on 100 percent of its assigned beneficiaries. A group practice would be
required to report on at least 1 measure for which there is Medicare
patient data.
In addition, we propose to modify Sec. 414.90(j) to incorporate
the following criteria for the satisfactory reporting of PQRS quality
measures for group practices that registered to participate in the GPRO
for the 12-month reporting period for the 2017 PQRS payment adjustment
using the GPRO web interface for groups practices of 100 or more
eligible professionals: The group practice would report all CAHPS for
PQRS survey measures via a certified survey vendor. In addition, the
group practice would report on all measures included in the GPRO web
interface; AND populate data fields for the first 248 consecutively
ranked and assigned beneficiaries in the order in which they appear in
the group's sample for each module or preventive care measure. If the
pool of eligible assigned beneficiaries is less than 248, then the
group practice would report on 100 percent of assigned beneficiaries. A
group practice would be required to report on at least 1 measure for
which there is Medicare patient data.
To maintain consistency in this reporting criteria, we note that
this proposed criteria is similar to the criterion we finalized for the
satisfactory reporting of PQRS quality measures for group practices
selected to participate in the GPRO for the 12-month reporting periods
for the 2013 and 2014 PQRS incentives for group practices of 100 or
more eligible professionals in the CY 2013 PFS final rule with comment
period (see Table 49 at 78 FR 74486). However, we are proposing to
reduce the patient sample size a group practice is required to report
quality measures data from 411 to 248. We examined the sample size of
this reporting criterion and determined that the sample size we are
proposing reduces provider reporting burden while still allowing for
statistically valid and reliable performance results. For the 25-99
sized groups reporting via the web interface, we recognize the proposal
to move from reporting 218 to 248 patients per sample represents a
slight increase in reporting. However, based on experience with the 218
count and subsequent statistical analysis, we believe that there are
increased performance reliabilities and validities gained when changing
the minimum reporting requirement to 248. We believe statistical
reliability and validity is extremely important when measuring provider
performance, particularly given the implications of the Physician VM
and Physician Compare public reporting, discussed in section III.N and
section III.J respectively. Therefore, we believe this proposed
criterion improves on the criterion previously finalized.
For assignment of patients for group practices reporting via the
GPRO web interface, in previous years, we have aligned with the
Medicare Shared Savings Program methodology of beneficiary assignment
(see 77 FR 69195). We note that, in section III.N. of this proposed
rule, we are proposing to use a beneficiary attribution methodology for
the VM for the claims-based quality measures and cost measures that is
slightly different from the Medicare Shared Savings Program
methodology, namely (1) eliminating the primary care service pre-step
that is statutorily required for the Shared Savings Program and (2)
including NPs, PA, and CNSs in step 1 rather than in step 2 of the
attribution process. We believe that aligning with the VM's proposed
method of attribution is appropriate, as the VM is directly tied to
participation in the PQRS. Therefore, to achieve further alignment with
the VM and for the reasons proposed in section III.N., we propose to
adopt the attribution methodology changes proposed for the VM into the
GPRO web interface beneficiary assignment methodology.
In addition, we note that, in the past, we have not provided
guidance on those group practices that choose the GPRO web interface to
report PQRS quality measures but have seen no Medicare patients for
which the GPRO measures are applicable, or if they have no (i.e., 0
percent) responses for a particular module or measure. Since we are
moving solely towards the implementation of PQRS payment adjustments,
we seek to clarify this scenario here. If a group practice has no
Medicare patients for which any of the GPRO measures are applicable,
the group practice will not meet the criteria for satisfactory
reporting using the GPRO web interface. Therefore, to meet the criteria
for satisfactory reporting using the GPRO web interface, a group
practice must be assigned and have sampled at least 1 Medicare patient
for any of the applicable GPRO web interface measures (specified in
Table 21). If a group practice does not typically see Medicare patients
for which the GPRO web interface measures are applicable, we advise the
group practice to participate in the PQRS via another reporting
mechanism.
We invite public comment on these proposals.
b. Proposed Criteria for Satisfactory Reporting on Individual PQRS
Quality Measures for Group Practices Registered To Participate in the
GPRO via Registry and EHR for the 2017 PQRS Payment Adjustment
For registry reporting in the GPRO, in the CY 2014 PFS final rule
with comment period (see Table 49 at 78 FR 74486), we finalized the
following satisfactory reporting criteria for the submission of
individual quality measures via registry for group practices comprised
of 2 or more eligible professionals in the GPRO for the 2014 PQRS
incentive: Report at least 9 measures, covering at least 3 of the NQS
domains, OR, if less than 9 measures covering at least 3 NQS domains
apply to the group practice, report 1--8 measures covering 1-3 NQS
domains for which there is Medicare patient data, AND report each
measure for at least 50 percent of the group practice's Medicare Part B
FFS patients seen during the reporting period to which the measure
applies. Measures with a 0 percent performance rate would not be
counted. In the CY 2014 PFS final rule with comment period, we signaled
that it was ``our intent to ramp up the criteria for satisfactory
reporting for the 2017 PQRS payment adjustment to be on par or more
stringent than the criteria for satisfactory reporting for the 2014
PQRS incentive'' (78 FR 74465).
Consistent with the criterion finalized for the 2014 PQRS incentive
and the group practice reporting requirements under section
1848(m)(3)(C) of the Act, for those group practices that choose to
report using a qualified registry, we propose here to modify Sec.
414.90(j) to include the following satisfactory reporting criterion via
qualified registry for ALL group practices who select to participate in
the GPRO for the 2017 PQRS payment adjustment: The group practice would
report at least 9 measures, covering at least 3 of the NQS domains. Of
these measures, if a group practice sees at least 1 Medicare patient in
a face-to-face encounter, the group practice would report on at least 2
measures in the cross-cutting measure set specified in Table 21. If
less than 9 measures covering at least 3 NQS domains apply to the
eligible professional, the group practice would report up to 8 measures
covering 1-3 NQS domains for which there is Medicare patient data, AND
report each measure for at least 50 percent of the eligible
professional's Medicare Part B
[[Page 40399]]
FFS patients seen during the reporting period to which the measure
applies. Measures with a 0 percent performance rate would not be
counted.
As with individual reporting, we understand that there may be
instances where a group practice may not have at least 9 measures
applicable to a group practice's practice. In this instance, like the
criterion we finalized for the 2014 PQRS incentive (see Table 49 at 78
FR 74486), a group practice reporting on less than 9 measures would
still be able to meet the satisfactory reporting criterion via registry
if the group practice reports on as many measures as are applicable to
the group practice's practice. If a group practice reports on less than
9 measures, the group practice would be subject to the MAV process,
which would allow us to determine whether a group practice should have
reported quality data codes for additional measures and/or measures
covering additional NQS domains. In addition, if a group practice does
not report on at least 1 cross-cutting measure and the group practice
has at least 1 eligible professional who sees at least 1 Medicare
patient in a face-to-face encounter, the MAV will also allow us to
determine whether a group practice should have reported on any of the
proposed cross-cutting measures specified in Table 21. The MAV process
we are proposing to implement for registry reporting is the same
process that was established for reporting periods occurring in 2014
for the 2014 PQRS incentive. For more information on the registry MAV
process, please visit http://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/PQRS/Downloads/2014_PQRS_Registry_MeasureApplicabilityValidation_12132013.zip.
For EHR reporting, consistent with the criterion finalized for the
2014 PQRS incentive that aligns with the criteria established for
meeting the CQM component of meaningful use under the EHR Incentive
Program and in accordance with the group practice reporting
requirements under section 1848(m)(3)(C) of the Act, for those group
practices that choose to report using an EHR, we propose to modify
Sec. 414.90(j) to indicate the following satisfactory reporting
criterion via a direct EHR product that is CEHRT or an EHR data
submission vendor that is CEHRT for ALL group practices who select to
participate in the GPRO for the 2017 PQRS payment adjustment: For the
12-month reporting period for the 2017 PQRS payment adjustment, the
group practice would report 9 measures covering at least 3 domains. If
the group practice's CEHRT does not contain patient data for at least 9
measures covering at least 3 domains, then the group practice must
report the measures for which there is patient data. A group practice
must report on at least 1 measure for which there is Medicare patient
data.
We invite public comment on these proposals.
c. Proposed Criteria for Satisfactory Reporting on Individual PQRS
Quality Measures for Group Practices Registered To Participate in the
GPRO via a CMS-Certified Survey Vendor for the 2017 PQRS Payment
Adjustment
In the CY 2014 PFS final rule with comment period, we introduced
satisfactory reporting criterion for the 2014 PQRS incentive related to
reporting the CG CAHPS survey measures via a CMS-certified survey
vendor (see Table 49 at 78 FR 74486). Consistent with the criterion
finalized for the 2014 PQRS incentive and the group practice reporting
requirements under section 1848(m)(3)(C) of the Act, we are proposing
the following 3 options (of which a group practice would be able to
select 1 out of the 3 options) for satisfactory reporting for the 2017
PQRS payment adjustment for group practices comprised of 25 or more
eligible professionals:
Proposed Option 1: If a group practice chooses to use a qualified
registry, in conjunction with reporting the CAHPS for PQRS survey
measures, for the 12-month reporting period for the 2017 PQRS payment
adjustment, the group practice would report all CAHPS for PQRS survey
measures via a certified vendor, and report at least 6 additional
measures, outside of CAHPS for PQRS, covering at least 2 of the NQS
domains using the qualified registry. If less than 6 measures apply to
the group practice, the group practice must report all applicable
measures. Of these 6 measures, if any eligible professional in the
group practice sees at least 1 Medicare patient in a face-to-face
encounter, the group practice would be required to report on at least 1
measure in the cross-cutting measure set specified in Table 21. We note
that this proposed option to report 6 additional measures, including at
least 1 cross-cutting measure if a group practice sees at least 1
Medicare patient in a face-to-face encounter, is consistent with the
proposed criterion for satisfactory reporting for the 2017 PQRS payment
adjustment via qualified registry. However, unlike the proposed
criterion for satisfactory reporting for the 2017 PQRS payment
adjustment via qualified registry without CG-CAHPS, we are only
proposing the requirement to report 1 measure in the cross-cutting
measure set specified in Table 21 instead of 2 measures as the CAHPS
for PQRS measures are contained in the cross-cutting measure set.
Consistent with the proposed group practice reporting option solely
using a qualified registry for the 2017 PQRS payment adjustment, we
understand that there may be instances where a group practice may not
have at least 6 measures applicable to a group practice's practice. In
this instance, a group practice reporting on less than 6 measures would
still be able to meet the satisfactory reporting criterion via registry
if the group practice reports on as many measures as are applicable to
the group practice's practice. If a group practice reports on less than
6 individual measures using the qualified registry reporting mechanism
in conjunction with a CMS-certified survey vendor to report CAHPS for
PQRS, the group practice would be subject to a measure application
validity process (MAV), which would allow us to determine whether a
group practice should have reported quality data codes for additional
measures and/or measures covering additional NQS domains.
In addition, if a group practice does not report on at least 1
cross-cutting measure and the group practice has at least 1 eligible
professional who sees at least 1 Medicare patient in a face-to-face
encounter, the MAV will also allow us to determine whether a group
practice should have reported on any of the proposed cross-cutting
measures specified in Table 21. The MAV process we are proposing to
implement for registry reporting is the same process that was
established for reporting periods occurring in 2014 for the 2014 PQRS
incentive. For more information on the registry MAV process, please
visit http://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/PQRS/Downloads/2014_PQRS_Registry_MeasureApplicabilityValidation_12132013.zip.
Proposed Option 2: If a group practice chooses to use a direct EHR
product that is CEHRT or EHR data submission vendor that is CEHRT in
conjunction with reporting the CAHPS for PQRS survey measures, for the
12-month reporting period for the 2017 PQRS payment adjustment, the
group practice would report all CAHPS for PQRS survey measures via a
certified vendor, and report at least 6 additional measures, outside of
CAHPS for PQRS, covering at least 2 of the NQS domains using the direct
EHR product that is CEHRT or EHR data submission vendor that is CEHRT.
If less than 6 measures
[[Page 40400]]
apply to the group practice, the group practice must report all
applicable measures. Of the additional 6 measures that must be reported
in conjunction with reporting the CAHPS for PQRS survey measures, a
group practice would be required to report on at least 1 measure for
which there is Medicare patient data. We note that this proposed option
to report 6 additional measures is consistent with the proposed
criterion for satisfactory reporting for the 2017 PQRS payment
adjustment via EHR without CAHPS for PQRS, since the CAHPS for PQRS
survey only addresses 1 NQS domain.
Proposed Option 3: Alternatively, if a group practice chooses to
use the GPRO web interface in conjunction with reporting the CAHPS for
PQRS survey measures, we propose the following criterion for
satisfactory reporting for the 2017 PQRS payment adjustment: For the
12-month reporting period for the 2017 PQRS payment adjustment, the
group practice would report all CAHPS for PQRS survey measures via a
certified vendor. In addition, the group practice would report on all
measures included in the GPRO web interface; AND populate data fields
for the first 248 consecutively ranked and assigned beneficiaries in
the order in which they appear in the group's sample for each module or
preventive care measure. If the pool of eligible assigned beneficiaries
is less than 248, then the group practice would report on 100 percent
of assigned beneficiaries. A group practice would be required to report
on at least 1 measure for which there is Medicare patient data.
Furthermore, as was required for reporting periods occurring in
2014 (78 FR 74485), we propose that all group practices comprised of
100 or more eligible professionals that register to participate in the
PQRS GPRO, regardless of the reporting mechanism the group practice
chooses, would be required to select a CMS-certified survey vendor to
administer the CAHPS for PQRS survey on their behalf. As such, for
purposes of meeting the criteria for satisfactory reporting for the
2017 PQRS payment adjustment, a group practice participating in the
PQRS GPRO would be required to use 1 of these 3 proposed reporting
options mentioned above. We note that, for reporting periods occurring
in 2014, we stated that we would administer and fund the collection of
(CG-CAHPS) data for these groups (of 100 or more eligible professionals
using the GPRO web interface that are required to report on CAHPS for
PQRS survey measures) (78 FR 74452). We stated that we would bear the
cost of administering the CAHPS for PQRS survey measures, as we were
requiring the group practices to report on CAHPS for PQRS survey
measures. Unfortunately, beginning in 2015, it will no longer be
feasible for CMS to continue to bear the cost of group practices of 100
or more eligible professionals to report the CAHPS for PQRS survey
measures. Therefore, the group practice would be required to bear the
cost of administering the CAHPS for PQRS survey measures.
However, as CAHPS for PQRS was optional for group practices
comprised of 25-99 eligible professionals in 2014 (78 FR 74485) and
whereas we are proposing to require reporting of CAHPS for PQRS for
group practices comprised of 100 or more eligible professionals, we
propose that CAHPS for PQRS would be optional for groups of 25-99 and
2-24 eligible professionals. We note that all group practices that
would be required to report or voluntarily elect to report CAHPS for
PQRS would need to select and pay for a CMS-certified survey vendor to
administer the CAHPS for PQRS survey on their behalf.
We invite public comment on these proposals.
d. Proposed Criteria for Satisfactory Reporting on Individual PQRS
Quality Measures for Group Practices Selected To Participate in the
GPRO To Report the CAHPS for PQRS Survey Measures via a CMS-Certified
Survey Vendor for the 2018 PQRS Payment Adjustment and Subsequent Years
We believe these patient surveys are important tools for assessing
beneficiary experience of care and outcomes and, moving forward, we
would like to emphasize the importance of collecting patient experience
of care data through the use of CAHPS for PQRS. Therefore, based on our
authority under section 1848(m)(3)(C) of the Act to determine the
criteria for satisfactory reporting for group practices under section
1848(m)(3)(C) of the Act, we are proposing to require that, in
conjunction with other satisfactory reporting criteria we establish in
future years, beginning with the 12-month reporting period for the 2018
PQRS payment adjustment, and for subsequent years, group practices
comprised of 25 or more eligible professionals that are participating
in the GPRO report and pay for the collection of the CAHPS for PQRS
survey measures. We understand that the cost of administering the CAHPS
for PQRS survey may be significant, so we are proposing this
requirement well in advance of the year in which it would be first
effective in order to provide group practices with early notice so that
their practices may adjust accordingly.
We invite public comment on these proposals.
e. The Consumer Assessment of Healthcare Providers Surgical Care Survey
(S-CAHPS)
In addition to CAHPS for PQRS, we received comments last year
supporting the inclusion of the Consumer Assessment of Healthcare
Providers Surgical Care Survey (S-CAHPS). The commenters stated that
the CG-CAHPS survey would not accurately reflect the care provided by
single- or multispecialty surgical or anesthesia groups. The commenters
noted that S-CAHPS has been tested by the same standards as CG-CAHPS
and follows the same collection mechanism as the CG-CAHPS. The S-CAHPS
expands on the CG-CAHPS by focusing on aspects of surgical quality,
which are important from the patient's perspective and for which the
patient is the best source of information. The survey asks patients to
provide feedback on surgical care, surgeons, their staff, and
anesthesia care. It assesses patients' experiences with surgical care
in both the inpatient and outpatient settings by asking respondents
about their experience before, during and after surgery. We agree with
the commenters on the importance of allowing for the administration of
S-CAHPS reporting and wish to allow for reporting of S-CAHPS in the
PQRS for reporting mechanisms other than the QCDR. However, at this
time, due to the cost and time it would take to find vendors to collect
S-CAHPS data, it is not technically feasible to implement the reporting
of the S-CAHPS survey measures for the 2017 PQRS payment adjustment. We
seek comments on how to allow for reporting of the S-CAHPS survey
measures for the 2018 PQRS payment adjustment and beyond.
5. Statutory Requirements and Other Considerations for the Selection of
PQRS Quality Measures for Meeting the Criteria for Satisfactory
Reporting for 2015 and Beyond for Individual Eligible Professionals and
Group Practices
CMS undergoes an annual Call for Measures that solicits new
measures from the public for possible inclusion in the PQRS. During the
Call for Measures, we request measures for inclusion in PQRS that meet
the following statutory and non-statutory criteria.
Sections 1848(k)(2)(C) and 1848(m)(3)(C)(i) of the Act,
respectively, govern the quality measures reported by individual
eligible professionals and group practices under the PQRS. Under
[[Page 40401]]
section 1848(k)(2)(C)(i) of the Act, the PQRS quality measures shall be
such measures selected by the Secretary from measures that have been
endorsed by the entity with a contract with the Secretary under section
1890(a) of the Act, which is currently the National Quality Forum
(NQF). However, in the case of a specified area or medical topic
determined appropriate by the Secretary for which a feasible and
practical measure has not been endorsed by the NQF, section
1848(k)(2)(C)(ii) of the Act authorizes the Secretary to specify a
measure that is not so endorsed as long as due consideration is given
to measures that have been endorsed or adopted by a consensus
organization identified by the Secretary, such as the Ambulatory
Quality Alliance (AQA). In light of these statutory requirements, we
believe that, except in the circumstances specified in the statute,
each PQRS quality measure must be endorsed by the NQF. Additionally,
section 1848(k)(2)(D) of the Act requires that for each PQRS quality
measure, ``the Secretary shall ensure that eligible professionals have
the opportunity to provide input during the development, endorsement,
or selection of measures applicable to services they furnish.'' The
statutory requirements under section 1848(k)(2)(C) of the Act, subject
to the exception noted previously, require only that the measures be
selected from measures that have been endorsed by the entity with a
contract with the Secretary under section 1890(a) of the Act (that is,
the NQF) and are silent as to how the measures that are submitted to
the NQF for endorsement are developed.
The basic steps for developing measures applicable to physicians
and other eligible professionals prior to submission of the measures
for endorsement may be carried out by a variety of different
organizations. We do not believe there need to be special restrictions
on the type or make-up of the organizations carrying out this basic
process of development of physician measures, such as restricting the
initial development to physician-controlled organizations. Any such
restriction would unduly limit the basic development of quality
measures and the scope and utility of measures that may be considered
for endorsement as voluntary consensus standards for purposes of the
PQRS.
In addition to section 1848(k)(2)(C) of the Act, section 1890A of
the Act, which was added by section 3014(b) of the Affordable Care Act,
requires that the Secretary establish a pre-rulemaking process under
which certain steps occur with respect to the selection of certain
categories of quality and efficiency measures, one of which is that the
entity with a contract with the Secretary under section 1890(a) of the
Act (that is, the NQF) convene multi-stakeholder groups to provide
input to the Secretary on the selection of such measures. These
categories are described in section 1890(b)(7)(B) of the Act, and
include such measures as the quality measures selected for reporting
under the PQRS. In accordance with section 1890A(a)(1) of the Act, the
NQF convened multi-stakeholder groups by creating the Measure
Applications Partnership (MAP). Section 1890A(a)(2) of the Act requires
that the Secretary must make publicly available by December 1st of each
year a list of the quality and efficiency measures that the Secretary
is considering for selection through rulemaking for use in the Medicare
program. The NQF must provide CMS with the MAP's input on the selection
of measures by February 1st of each year. The lists of measures under
consideration for selection through rulemaking in 2014 are available at
http://www.qualityforum.org/map/.
As we noted above, section 1848(k)(2)(C)(ii) of the Act provides an
exception to the requirement that the Secretary select measures that
have been endorsed by the entity with a contract under section 1890(a)
of the Act (that is, the NQF). We may select measures under this
exception if there is a specified area or medical topic for which a
feasible and practical measure has not been endorsed by the entity, as
long as due consideration is given to measures that have been endorsed
or adopted by a consensus organization identified by the Secretary.
Under this exception, aside from NQF endorsement, we requested that
stakeholders apply the following considerations when submitting
measures for possible inclusion in the PQRS measure set:
Measures that are not duplicative of another existing or
proposed measure.
Measures that are further along in development than a
measure concept.
CMS is not accepting claims-based-only reporting measures
in this process.
Measures that are outcome-based rather than clinical
process measures.
Measures that address patient safety and adverse events.
Measures that identify appropriate use of diagnosis and
therapeutics.
Measures that include the NQS domain for care coordination
and communication.
Measures that include the NQS domain for patient
experience and patient-reported outcomes.
Measures that address efficiency, cost and resource use.
a. Proposed PQRS Quality Measures
Taking into consideration the statutory and non-statutory criteria
we described previously, this section contains our proposals for the
inclusion or removal of measures in PQRS for 2015 and beyond. We are
classifying all proposed measures against six domains based on the
NQS's six priorities, as follows:
(1) Patient Safety. These are measures that reflect the safe
delivery of clinical services in all healthcare settings. These
measures may address a structure or process that is designed to reduce
risk in the delivery of healthcare or measure the occurrence of an
untoward outcome such as adverse events and complications of procedures
or other interventions.
(2) Person and Caregiver-Centered Experience and Outcomes. These
are measures that reflect the potential to improve patient-centered
care and the quality of care delivered to patients. They emphasize the
importance of collecting patient-reported data and the ability to
impact care at the individual patient level, as well as the population
level. These are measures of organizational structures or processes
that foster both the inclusion of persons and family members as active
members of the health care team and collaborative partnerships with
providers and provider organizations or can be measures of patient-
reported experiences and outcomes that reflect greater involvement of
patients and families in decision making, self-care, activation, and
understanding of their health condition and its effective management.
(3) Communication and Care Coordination. These are measures that
demonstrate appropriate and timely sharing of information and
coordination of clinical and preventive services among health
professionals in the care team and with patients, caregivers, and
families to improve appropriate and timely patient and care team
communication. They may also be measures that reflect outcomes of
successful coordination of care.
(4) Effective Clinical Care. These are measures that reflect
clinical care processes closely linked to outcomes based on evidence
and practice guidelines or measures of patient-centered outcomes of
disease states.
(5) Community/Population Health. These are measures that reflect
the use of clinical and preventive services and achieve improvements in
the health of the population served. They may be
[[Page 40402]]
measures of processes focused on primary prevention of disease or
general screening for early detection of disease unrelated to a current
or prior condition.
(6) Efficiency and Cost Reduction. These are measures that reflect
efforts to lower costs and to significantly improve outcomes and reduce
errors. These are measures of cost, resource use and appropriate use of
healthcare resources or inefficiencies in healthcare delivery.
Please note that the PQRS quality measure specifications for any
given proposed PQRS individual quality measure may differ from
specifications for the same quality measure used in prior years. For
example, for the proposed PQRS quality measures that were selected for
reporting in 2014 and beyond, please note that detailed measure
specifications, including the measure's title, for the proposed
individual PQRS quality measures for 2013 and beyond may have been
updated or modified during the NQF endorsement process or for other
reasons.
In addition, due to our desire to align measure titles with the
measure titles that have been finalized for 2013, 2014, 2015, and
potentially subsequent years of the EHR Incentive Program, we note that
the measure titles for measures available for reporting via EHR may
change. To the extent that the EHR Incentive Program updates its
measure titles to include version numbers (77 FR 13744), we will use
these version numbers to describe the PQRS EHR measures that will also
be available for reporting for the EHR Incentive Program. We will
continue to work toward complete alignment of measure specifications
across programs whenever possible.
Through NQF's measure maintenance process, NQF-endorsed measures
are sometimes updated to incorporate changes that we believe do not
substantively change the nature of the measure. Examples of such
changes could be updated diagnosis or procedure codes or changes to
exclusions to the patient population or definitions. We believe these
types of maintenance changes are distinct from substantive changes to
measures that result in what are considered new or different measures.
Further, we believe that non-substantive maintenance changes of this
type do not trigger the same agency obligations under the
Administrative Procedure Act.
In the CY 2013 PFS final rule with comment period, we finalized our
proposal providing that if the NQF updates an endorsed measure that we
have adopted for the PQRS in a manner that we consider to not
substantively change the nature of the measure, we would use a
subregulatory process to incorporate those updates to the measure
specifications that apply to the program (77 FR 69207). We believe this
adequately balances our need to incorporate non-substantive NQF updates
to NQF-endorsed measures in the most expeditious manner possible, while
preserving the public's ability to comment on updates that so
fundamentally change an endorsed measure that it is no longer the same
measure that we originally adopted. We also note that the NQF process
incorporates an opportunity for public comment and engagement in the
measure maintenance process. We will revise the Specifications Manual
and post notices to clearly identify the updates and provide links to
where additional information on the updates can be found. Updates will
also be available on the CMS PQRS Web site at http://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/PQRS/index.html.
CMS is not the measure steward for most of the measures available
for reporting under the PQRS. We rely on outside measure stewards and
developers to maintain these measures. In Table 24, we are proposing
that certain measures be removed from the PQRS measure set due to the
measure owner/developer indicating that it will not be able to maintain
the measure. We note that this proposal is contingent upon the measure
owner/developer not being able to maintain the measure. Should we learn
that a certain measure owner/developer is able to maintain the measure,
or that another entity is able to maintain the measure in a manner that
allows the measure to be available for reporting under the PQRS for the
CY 2017 PQRS payment adjustment, we propose to keep the measure
available for reporting under the PQRS and therefore not finalize our
proposal to remove the measure. In addition, if, after the display of
this proposed rule, we discover additional measures within the current
PQRS measure set that a measure owner/developer can no longer maintain,
we propose to remove these measures from reporting for the PQRS
beginning in 2015. We will discuss any such instances in the CY 2015
PFS final rule with comment period.
In addition, we note that we have received feedback from
stakeholders, particularly first-time participants who find it
difficult to understand which measures are applicable to their
particular practice. In an effort to aide eligible professionals and
group practices to determine what measures best fit their practice, and
in collaboration with specialty societies, we are beginning to group
our final measures available for reporting according to specialty. The
current listing of our measures by specialty can be found on our Web
site at http://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/PQRS/index.html. Please note that these groups
of measures are meant to provide guidance to those eligible
professionals seeking to determine what measures to report. Eligible
professionals are not required to report measures according to these
suggested groups of measures. In addition to group measures according
to specialty, we also plan to have a measure subset for measures that
specifically addresses multiple chronic conditions. As measures are
adopted or revised, we will continue to update these groups to reflect
the measures available under the PQRS, as well as add more specialties.
In the CY 2014 PFS final rule with comment period, we stated that
``unless there are errors discovered in updated electronic measure
specifications, the PQRS intends to use the most recent, updated
versions of electronically specified clinical quality measures for that
year'' (78 FR 74489). We propose that, if we discover errors in the
most recently updated electronic measure specifications for a certain
measure, we would use the version of electronic measure specifications
that immediately precedes the most recently updated electronic measure
specifications.
Additionally, we noted that, with respect to the following e-
measure CMS140v2, Breast Cancer Hormonal Therapy for Stage IC-IIIC
Estrogen Receptor/Progesterone Receptor (ER/PR) Positive Breast Cancer
(NQF 0387), a substantive error was discovered in the June 2013 version
of this electronically specified clinical quality measure. Therefore,
the PQRS required the use of the prior, December 2012 version of this
measure, which is CMS140v1 (78 FR 74489). Please note that, consistent
with other EHR measures, since a more recent and corrected version of
this measure has been developed, we will require the reporting of the
most recent, updated versions of the measure Breast Cancer Hormonal
Therapy for Stage IC-IIIC Estrogen Receptor/Progesterone Receptor (ER/
PR) Positive Breast Cancer (NQF 0387)--currently version CMS140v3--for
the year.
b. Proposed Cross-Cutting Measure Set for 2015 and Beyond
In accordance with our proposed criteria for the satisfactory
reporting of
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PQRS measures for the 2017 PQRS payment adjustment via claims and
registry that requires an eligible professional or group practice to
report on at least 2 cross-cutting measures, we are proposing the
following 18 cross-cutting measure set specified in Table 21 for 2015
and beyond. Please note that our rationale for proposing each of these
measures is found below the measure description. We have also indicated
the PQRS reporting mechanism or mechanisms through which each proposed
measure could be submitted. In addition to seeking comment on this
proposed cross-cutting measure set specified in Table 21, we seek
comment on other measures that commenters believe should be included in
this proposed cross-cutting measure set for 2015 and beyond.
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c. Proposed New PQRS Measures Available for Reporting for 2015 and
Beyond
Table 22 contains the additional measures we are proposing to
include in the PQRS measure set for CY 2015 and beyond. Please note
that not all of the proposed cross-cutting measures may appear in Table
22, as some of the propose cross-cutting measures specified in Table 21
were finalized in the CY 2013 or CY 2014 PFS final rules with comment
period. Please note that our rationale for proposing each of these
measures is found below the measure description. We have also indicated
the PQRS reporting mechanism or mechanisms through which each proposed
measure could be submitted.
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In Table 23, we specify the measures for which we are proposing a
NQS domain change for reporting under the PQRS. Please note the
rationale we have for each measure for which we are proposing a NQS
domain change below.
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In Table 24, we specify the measures we are proposing to remove
from reporting under the PQRS. Please note that the rationale we have
for each measure we are proposing to remove is specified after the
measure title and description.
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In Table 25 below, we specify our proposals to change the way in
which previously established measures in the PQRS will be reported
beginning in 2015. Please note that, in Table 25, we provide our
explanation as to how we are proposing to change the way the measure is
reported, as well as a corresponding rationale for this proposed
change.
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We seek comment on these proposals.
d. PQRS Measures Groups
Section 414.90(b) defines a measures group as a subset of four or
more Physician Quality Reporting System measures that have a particular
clinical condition or focus in common. The denominator definition and
coding of the measures group identifies the condition or focus that is
shared across the measures within a particular measures group.
In the CY 2014 PFS proposed rule, we proposed (78 FR 43448) to
increase the number of measures that may be included in a measures
group from a minimum of 4 measures to a minimum of 6. We proposed
increasing the minimum number of measures that may be contained in a
measures group in accordance with increasing the number of individual
measures to be reported via claims and registry. However, we did not
finalize this proposal, stating that, although we still plan to
increase the minimum number of measures in a measures group in the
future, we would work with the measure developers and owners of these
measures groups to appropriately add measures to measures groups that
only contain four measures within the measures group (78 FR 74730). We
have worked with the measure owners and developers and are again
proposing to increase the number of measures that may be included in a
measures group from a minimum of 4 measures to a minimum of 6.
Specifically, we are proposing to modify section 414.90(b) to
define a measures group as a subset of six or more Physician Quality
Reporting System measures that have a particular clinical condition or
focus in common.
In addition, we are proposing two new measures groups that will be
available for reporting in the PQRS beginning in 2015:
The sinusitis measures group: We are proposing a new
sinusitis measures group because this measures group represents a
clinical gap within the measure group reporting option. The measures in
the sinusitis measures group reflect a variety of measure types, and
make up a clinically coherent and meaningful set of measures.
The Acute Otits Externa (AOE) measures group: We are
proposing the addition of the AOE measures group, as it focuses on the
quality of care of patients with AOE by combining existing disease-
specific measures with relevant cross-cutting (generic) measures.
Furthermore, we are proposing to remove the following measures
groups for reporting beginning in 2015 for the following reasons:
Perioperative care measures group: We are proposing to
remove the perioperative care measures group from reporting in the PQRS
beginning in 2015 because this measures group does not add value to the
PQRS and eligible professionals are consistently meeting performance on
this measure with performance rates close to 100 percent.
Back pain measures group: We are proposing to remove the
back pain measures group because the measure steward is not preparing
these measures for re-endorsement by the National Quality Forum. We are
also proposing to remove the measures group because it reflects
clinical concepts that do not add clinical value to PQRS. Specifically,
the measures in this group are entirely clinical process measures that
do not meaningfully contribute to improved patient outcomes.
Cardiovascular prevention measures group: We are proposing
to remove the cardiovascular prevention measures group because a number
of individual measures contained in this measures group are proposed to
be removed from all PQRS program reporting options with the exception
of EHR reporting.
Ischemic Vascular Disease (IVD) measures group: We are
proposing to remove the IVD measures group because a number of
individual measures contained in this measures group are proposed to be
removed from all PQRS program reporting options with the exception of
EHR reporting.
Sleep Apnea measures group: We are proposing to remove the
Sleep Apnea measures group from reporting in the PQRS beginning in 2015
because, for a number of measures included in this group, the measure
steward has indicated they will no longer maintain those measures.
Those measures and their associated measure groups are proposed for
removal from the program. As a result, the measures group would have
less than the 6 measures proposed to be required in a measures group.
Please note that this proposal is contingent on the measure steward not
being able to maintain ownership of certain measures. Should we learn
that a measure owner/developer is able to maintain certain measures, or
that another entity is able to maintain certain measures, such that the
measure group maintains a sufficient number of measures for reporting
under the PQRS for the CY 2017 PQRS payment adjustment, we propose to
keep the measure group available for reporting under the PQRS and
therefore not finalize our proposal to remove the measure group.
Chronic obstructive pulmonary disease (COPD) measures
group: We are proposing to remove the COPD measures group from
reporting in the PQRS beginning in 2015 because, for a number of
measures included in this group, the measure steward has indicated they
will no longer maintain those measures. Those measures and their
associated measure groups are proposed for removal from the program. As
a result, the measures group would have less than the 6 measures
proposed to be required in a measures group. Please note that this
proposal is contingent on the measure steward not being able to
maintain ownership of certain measures. Should we learn that a measure
owner/developer is able to maintain certain measures, or that another
entity is able to maintain certain measures, such that the measure
group maintains a sufficient number of measures for reporting under the
PQRS for the CY 2017 PQRS payment adjustment, we propose to keep the
measure group available for reporting under the PQRS and therefore not
finalize our proposal to remove the measure group.
Tables 26 through 48 specify our proposed measures groups in light
of our proposal to increase the minimum number of measures in a
measures group in previously established measures groups, so that each
measures group contains at least 6 measures. We invite public comment
on these proposals.
Table 26--Proposed Asthma Measures Group for 2015 and Beyond
----------------------------------------------------------------------------------------------------------------
NQF/ PQRS Measure title and description Measure developer
----------------------------------------------------------------------------------------------------------------
0047/053................. Asthma: Pharmacologic Therapy for Persistent AMA-PCPI/NCQA
Asthma--Ambulatory Care Setting: Percentage of
patients aged 5 through 64 years with a
diagnosis of persistent asthma who were
prescribed long-term control medication.
[[Page 40458]]
0041/110................. Preventive Care and Screening: Influenza AMA-PCPI
Immunization: Percentage of patients aged 6
months and older seen for a visit between
October 1 and March 31 who received an influenza
immunization OR who reported previous receipt of
an influenza immunization.
0419/130................. Documentation of Current Medications in the CMS/QIP
Medical Record: Percentage of visits for
patients aged 18 years and older for which the
eligible professional attests to documenting a
list of current medications using all immediate
resources available on the date of the
encounter. This list must include ALL known
prescriptions, over-the-counters, herbals, and
vitamin/mineral/dietary (nutritional)
supplements AND must contain the medications'
name, dosage, frequency and route of
administration.
0028/226................. Preventive Care and Screening: Tobacco Use: AMA-PCPI
Screening and Cessation Intervention: Percentage
of patients aged 18 years and older who were
screened for tobacco use one or more times
within 24 months AND who received cessation
counseling intervention if identified as a
tobacco user.
N/A/N/A.................. Tobacco Use and Help with Quitting Among NCQA/NCIQM
Adolescents: Percentage of adolescents 13 to 20
years of age with a primary care visit during
the measurement period for whom tobacco use
status was documented and received help quitting
if identified as a tobacco user.
0421/128................. Preventive Care and Screening: Body Mass Index CMS/QIP
(BMI) Screening and Follow-Up: Percentage of
patients aged 18 years and older with a
documented BMI during the current encounter or
during the previous 6 months AND when the BMI is
outside of normal parameters, a follow-up plan
is documented during the encounter or during the
previous 6 months of the encounter.
Normal Parameters: Age 65 years and older BMI >=
23 and < 30; Age 18-64 years BMI >= 18.5 and <
25.
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Table 27--Proposed Acute Otitis Externa (AOE) Measures Group for 2015 and Beyond
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NQF/ PQRS Measure title and description Measure developer
----------------------------------------------------------------------------------------------------------------
0653/091................. Acute Otitis Externa (AOE): Topical Therapy: AMA-PCPI
Percentage of patients aged 2 years and older
with a diagnosis of AOE who were prescribed
topical preparations.
0654/093................. Acute Otitis Externa (AOE): Systemic AMA-PCPI
Antimicrobial Therapy--Avoidance of
Inappropriate Use: Percentage of patients aged 2
years and older with a diagnosis of AOE who were
not prescribed systemic antimicrobial therapy.
0419/130................. Documentation of Current Medications in the CMS/QIP
Medical Record: Percentage of visits for
patients aged 18 years and older for which the
eligible professional attests to documenting a
list of current medications using all immediate
resources available on the date of the
encounter. This list must include ALL known
prescriptions, over-the-counters, herbals, and
vitamin/mineral/dietary (nutritional)
supplements AND must contain the medications'
name, dosage, frequency and route of
administration.
0420/131................. Pain Assessment and Follow-Up: Percentage of CMS/QIP
visits for patients aged 18 years and older with
documentation of a pain assessment using a
standardized tool(s) on each visit AND
documentation of a follow-up plan when pain is
present.
0101/154................. Falls: Risk Assessment: Percentage of patients AMA-PCPI
aged 65 years and older with a history of falls
who had a risk assessment for falls completed
within 12 months.
0101/155................. Falls: Plan of Care: Percentage of patients aged AMA-PCPI
65 years and older with a history of falls who
had a plan of care for falls documented within
12 months.
0028/226................. Preventive Care and Screening: Tobacco Use: AMA-PCPI
Screening and Cessation Intervention: Percentage
of patients 18 years and older who were screened
for tobacco use one or more times within 24
months AND who received cessation counseling
intervention if identified as a tobacco user.
N/A/317.................. Preventive Care and Screening: Screening for High CMS/QIP
Blood Pressure and Follow-Up Documented:
Percentage of patients aged 18 years and older
seen during the reporting period who were
screened for high blood pressure (BP) AND a
recommended follow-up plan is documented based
on the current blood pressure reading as
indicated.
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Table 28--Proposed Cataracts Measures Group for 2015 and Beyond
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0419/130................. Documentation of Current Medications in the CMS/QIP
Medical Record: Percentage of visits for
patients aged 18 years and older for which the
eligible professional attests to documenting a
list of current medications using all immediate
resources available on the date of the
encounter. This list must include ALL known
prescriptions, over-the-counters, herbals, and
vitamin/mineral/dietary (nutritional)
supplements AND must contain the medications'
name, dosage, frequency and route of
administration.
0565/191................. Cataracts: 20/40 or Better Visual Acuity within AMA-PCPI/NCQA
90 Days Following Cataract Surgery: Percentage
of patients aged 18 years and older with a
diagnosis of uncomplicated cataract who had
cataract surgery and no significant ocular
conditions impacting the visual outcome of
surgery and had best-corrected visual acuity of
20/40 or better (distance or near) achieved
within 90 days following the cataract surgery.
[[Page 40459]]
0564/192................. Cataracts: Complications within 30 Days Following AMA-PCPI/NCQA
Cataract Surgery Requiring Additional Surgical
Procedures: Percentage of patients aged 18 years
and older with a diagnosis of uncomplicated
cataract who had cataract surgery and had any of
a specified list of surgical procedures in the
30 days following cataract surgery which would
indicate the occurrence of any of the following
major complications: retained nuclear fragments,
endophthalmitis, dislocated or wrong power IOL,
retinal detachment, or wound dehiscence.
0028/226................. Preventive Care and Screening: Tobacco Use: AMA-PCPI
Screening and Cessation Intervention: Percentage
of patients 18 years and older who were screened
for tobacco use one or more times within 24
months AND who received cessation counseling
intervention if identified as a tobacco user.
N/A/303.................. Cataracts: Improvement in Patient's Visual AAO
Function within 90 Days Following Cataract
Surgery: Percentage of patients aged 18 years
and older in sample who had cataract surgery and
had improvement in visual function achieved
within 90 days following the cataract surgery,
based on completing a pre-operative and post-
operative visual function survey.
N/A/304.................. Cataracts: Patient Satisfaction within 90 Days AAO
Following Cataract Surgery: Percentage of
patients aged 18 years and older in sample who
had cataract surgery and were satisfied with
their care within 90 days following the cataract
surgery, based on completion of the Consumer
Assessment of Healthcare Providers and Systems
Surgical Care Survey.
N/A/358.................. Patient-Centered Surgical Risk Assessment and ACS
Communication: Percentage of patients who
underwent a non-emergency surgery who had their
personalized risks of postoperative
complications assessed by their surgical team
prior to surgery using a clinical data-based,
patient-specific risk calculator and who
received personal discussion of those risks with
the surgeon.
N/A/N/A.................. Cataract Surgery with Intra-Operative AAEECE/ACHS
Complications (Unplanned Rupture of Posterior
Capsule requiring unplanned vitrectomy): Rupture
of the posterior capsule during anterior segment
surgery requiring vitrectomy.
N/A/N/A.................. Cataract Surgery: Difference Between Planned and AAEECE/ACHS
Final Refraction: Percentage of patients who
achieve planned refraction within +-1,0 D.
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Table 29--Proposed Chronic Kidney Disease (CKD) Measures Group for 2015 and Beyond
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0326/047................. Care Plan: Percentage of patients aged 65 years AMA-PCPI/NCQA
and older who have an care plan or surrogate
decision maker documented in the medical record
or documentation in the medical record that an
care plan was discussed but the patient did not
wish or was not able to name a surrogate
decision maker or provide an care plan.
0041/110................. Preventive Care and Screening: Influenza AMA-PCPI
Immunization: Percentage of patients aged 6
months and older seen for a visit between
October 1 and March 31 who received an influenza
immunization OR who reported previous receipt of
an influenza immunization.
1668/121................. Adult Kidney Disease: Laboratory Testing (Lipid AMA-PCPI
Profile): Percentage of patients aged 18 years
and older with a diagnosis of chronic kidney
disease (CKD) (stage 3, 4, or 5, not receiving
Renal Replacement Therapy [RRT]) who had a
fasting lipid profile performed at least once
within a 12-month period.
N/A/122.................. Adult Kidney Disease: Blood Pressure Management: AMA-PCPI
Percentage of patient visits for those patients
aged 18 years and older with a diagnosis of
chronic kidney disease (CKD) (stage 3, 4, or 5,
not receiving Renal Replacement Therapy [RRT])
and proteinuria with a blood pressure < 130/80
mmHg OR >= 130/80 mmHg with a documented plan of
care.
0419/130................. Documentation of Current Medications in the CMS/QIP
Medical Record: Percentage of visits for
patients aged 18 years and older for which the
eligible professional attests to documenting a
list of current medications using all immediate
resources available on the date of the
encounter. This list must include ALL known
prescriptions, over-the-counters, herbals, and
vitamin/mineral/dietary (nutritional)
supplements AND must contain the medications'
name, dosage, frequency and route of
administration.
0028/226................. Preventive Care and Screening: Tobacco Use: AMA-PCPI
Screening and Cessation Intervention: Percentage
of patients 18 years and older who were screened
for tobacco use one or more times within 24
months AND who received cessation counseling
intervention if identified as a tobacco user.
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[[Page 40460]]
Table 30--Proposed Chronic Obstructive Pulmonary Disorder (COPD) Measures Group for 2015 and Beyond
[Please note that we are proposing to remove this measure group contingent on the measure steward not being able
to maintain certain measures contained in these measures group. If a measure steward is able to maintain
ownership of these measures, we plan to keep this measures group in the PQRS measure set. This Table Q10
indicates the measures that we propose will be available in this measures group should we keep this measures
group in the PQRS measure set.]
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0326/047................. Care Plan: Percentage of patients aged 65 years AMA-PCPI/NCQA
and older who have an care plan or surrogate
decision maker documented in the medical record
or documentation in the medical record that an
care plan was discussed but the patient did not
wish or was not able to name a surrogate
decision maker or provide an care plan.
0091/051................. Chronic Obstructive Pulmonary Disease (COPD): AMA-PCPI
Spirometry Evaluation: Percentage of patients
aged 18 years and older with a diagnosis of COPD
who had spirometry evaluation results documented.
0102/052................. Chronic Obstructive Pulmonary Disease (COPD): AMA-PCPI
Inhaled Bronchodilator Therapy: Percentage of
patients aged 18 years and older with a
diagnosis of COPD and who have an FEV1/FVC less
than 60% and have symptoms who were prescribed
an inhaled bronchodilator.
0041/110................. Preventive Care and Screening: Influenza AMA-PCPI
Immunization: Percentage of patients aged 6
months and older seen for a visit between
October 1 and March 31 who received an influenza
immunization OR who reported previous receipt of
an influenza immunization.
0043/111................. Pneumonia Vaccination Status for Older Adults: NCQA
Percentage of patients 65 years of age and older
who have ever received a pneumococcal vaccine.
0419/130................. Documentation of Current Medications in the CMS/QIP
Medical Record: Percentage of visits for
patients aged 18 years and older for which the
eligible professional attests to documenting a
list of current medications using all immediate
resources available on the date of the
encounter. This list must include ALL known
prescriptions, over-the-counters, herbals, and
vitamin/mineral/dietary (nutritional)
supplements AND must contain the medications'
name, dosage, frequency and route of
administration.
0028/226................. Preventive Care and Screening: Tobacco Use: AMA-PCPI
Screening and Cessation Intervention: Percentage
of patients 18 years and older who were screened
for tobacco use one or more times within 24
months AND who received cessation counseling
intervention if identified as a tobacco user.
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Table 31--Proposed Coronary Artery Bypass Graft (CABG) Measures Group for 2015 and Beyond
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0134/043................. Coronary Artery Bypass Graft (CABG): Use of STS
Internal Mammary Artery (IMA) in Patients with
Isolated CABG Surgery: Percentage of patients
aged 18 years and older undergoing isolated CABG
surgery who received an IMA graft.
0236/044................. Coronary Artery Bypass Graft (CABG): Preoperative CMS/QIP
Beta-Blocker in Patients with Isolated CABG
Surgery: Percentage of isolated Coronary Artery
Bypass Graft (CABG) surgeries for patients aged
18 years and older who received a beta-blocker
within 24 hours prior to surgical incision.
0129/164................. Coronary Artery Bypass Graft (CABG): Prolonged STS
Intubation: Percentage of patients aged 18 years
and older undergoing isolated CABG surgery who
require postoperative intubation > 24 hours.
0130/165................. Coronary Artery Bypass Graft (CABG): Deep Sternal STS
Wound Infection Rate: Percentage of patients
aged 18 years and older undergoing isolated CABG
surgery who, within 30 days postoperatively,
develop deep sternal wound infection involving
muscle, bone, and/or mediastinum requiring
operative intervention.
0131/166................. Coronary Artery Bypass Graft (CABG): Stroke: STS
Percentage of patients aged 18 years and older
undergoing isolated CABG surgery who have a
postoperative stroke (i.e., any confirmed
neurological deficit of abrupt onset caused by a
disturbance in blood supply to the brain) that
did not resolve within 24 hours.
0114/167................. Coronary Artery Bypass Graft (CABG): STS
Postoperative Renal Failure: Percentage of
patients aged 18 years and older undergoing
isolated CABG surgery (without pre-existing
renal failure) who develop postoperative renal
failure or require dialysis.
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Table 32--Proposed Coronary Artery Disease (CAD) Measures Group for 2015 and Beyond
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0067/006................. Coronary Artery Disease (CAD): Antiplatelet AMA-PCPI/ACCF/AHA
Therapy: Percentage of patients aged 18 years
and older with a diagnosis of coronary artery
disease seen within a 12 month period who were
prescribed aspirin or clopidogrel.
0070/007................. Coronary Artery Disease (CAD): Beta-Blocker AMA-PCPI
Therapy--Prior Myocardial Infarction (MI) or
Left Ventricular Systolic Dysfunction (LVEF <
40%: Percentage of patients aged 18 years and
older with a diagnosis of coronary artery
disease seen within a 12 month period who also
have prior MI OR a current or LVEF < 40% who
were prescribed beta-blocker therapy.
[[Page 40461]]
0421/128................. Preventive Care and Screening: Body Mass Index CMS/QIP
(BMI) Screening and Follow-Up: Percentage of
patients aged 18 years and older with a
documented BMI during the current encounter or
during the previous 6 months AND when the BMI is
outside of normal parameters, a follow-up plan
is documented during the encounter or during the
previous 6 months of the encounter.
Normal Parameters: Age 65 years and older BMI >=
23 and < 30; Age 18-64 years BMI >= 18.5 and <
25.
0419/130................. Documentation of Current Medications in the CMS/QIP
Medical Record: Percentage of visits for
patients aged 18 years and older for which the
eligible professional attests to documenting a
list of current medications using all immediate
resources available on the date of the
encounter. This list must include ALL known
prescriptions, over-the-counters, herbals, and
vitamin/mineral/dietary (nutritional)
supplements AND must contain the medications'
name, dosage, frequency and route of
administration.
0028/226................. Preventive Care and Screening: Tobacco Use: AMA-PCPI
Screening and Cessation Intervention: Percentage
of patients 18 years and older who were screened
for tobacco use one or more times within 24
months AND who received cessation counseling
intervention if identified as a tobacco user.
N/A/242.................. Coronary Artery Disease (CAD): Symptom AMA-PCPI/ACCF/AHA
Management: Percentage of patients aged 18 years
and older with a diagnosis of coronary artery
disease seen within a 12 month period with
results of an evaluation of level of activity
and an assessment of whether anginal symptoms
are present or absent with appropriate
management of anginal symptoms within a 12 month
period.
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Table 33--Proposed Dementia Measures Group for 2015 and Beyond
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0326/047................. Care Plan: Percentage of patients aged 65 years AMA-PCPI/NCQA
and older who have an care plan or surrogate
decision maker documented in the medical record
or documentation in the medical record that an
care plan was discussed but the patient did not
wish or was not able to name a surrogate
decision maker or provide an care plan.
N/A/280.................. Dementia: Staging of Dementia: Percentage of AMA-PCPI
patients, regardless of age, with a diagnosis of
dementia whose severity of dementia was
classified as mild, moderate or severe at least
once within a 12 month period.
N/A/281.................. Dementia: Cognitive Assessment: Percentage of AMA-PCPI
patients, regardless of age, with a diagnosis of
dementia for whom an assessment of cognition is
performed and the results reviewed at least once
within a 12 month period.
N/A/282.................. Dementia: Functional Status Assessment: AMA-PCPI
Percentage of patients, regardless of age, with
a diagnosis of dementia for whom an assessment
of functional status is performed and the
results reviewed at least once within a 12 month
period.
N/A/283.................. Dementia: Neuropsychiatric Symptom Assessment: AMA-PCPI
Percentage of patients, regardless of age, with
a diagnosis of dementia and for whom an
assessment of neuropsychiatric symptoms is
performed and results reviewed at least once in
a 12 month period.
N/A/284.................. Dementia: Management of Neuropsychiatric AMA-PCPI
Symptoms: Percentage of patients, regardless of
age, with a diagnosis of dementia who have one
or more neuropsychiatric symptoms who received
or were recommended to receive an intervention
for neuropsychiatric symptoms within a 12 month
period.
N/A/285.................. Dementia: Screening for Depressive Symptoms: AMA-PCPI
Percentage of patients, regardless of age, with
a diagnosis of dementia who were screened for
depressive symptoms within a 12 month period.
N/A/286.................. Dementia: Counseling Regarding Safety Concerns: AMA-PCPI
Percentage of patients, regardless of age, with
a diagnosis of dementia or their caregiver(s)
who were counseled or referred for counseling
regarding safety concerns within a 12 month
period.
N/A/287.................. Dementia: Counseling Regarding Risks of Driving: AMA-PCPI
Percentage of patients, regardless of age, with
a diagnosis of dementia or their caregiver(s)
who were counseled regarding the risks of
driving and the alternatives to driving at least
once within a 12 month period.
N/A/288.................. Dementia: Caregiver Education and Support: AMA-PCPI
Percentage of patients, regardless of age, with
a diagnosis of dementia whose caregiver(s) were
provided with education on dementia disease
management and health behavior changes AND
referred to additional sources for support
within a 12 month period.
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Table 34--Proposed Diabetes Measures Group for 2015 and Beyond
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0059/001................. Diabetes: Hemoglobin A1c Poor Control: Percentage NCQA
of patients 18-75 years of age with diabetes who
had hemoglobin A1c > 9.0% during the measurement
period.
0041/110................. Preventive Care and Screening: Influenza AMA-PCPI
Immunization: Percentage of patients aged 6
months and older seen for a visit between
October 1 and March 31 who received an influenza
immunization OR who reported previous receipt of
an influenza immunization.
0055/117................. Diabetes: Eye Exam: Percentage of patients 18 NCQA
through 75 years of age with a diagnosis of
diabetes (type 1 and type 2) who had a retinal
or dilated eye exam in the measurement period or
a negative retinal or dilated eye exam (negative
for retinopathy) in the year prior to the
measurement period.
[[Page 40462]]
0062/119................. Diabetes: Medical Attention for Neuropathy: The NCQA
percentage of patients 18-75 years of age with
diabetes who had a nephropathy screening test or
evidence of nephropathy during the measurement
period.
0056/163................. Diabetes: Foot Exam: Percentage of patients aged NCQA
18-75 years of age with diabetes who had a foot
exam during the measurement period.
0028/226................. Preventive Care and Screening: Tobacco Use: AMA-PCPI
Screening and Cessation Intervention: Percentage
of patients 18 years and older who were screened
for tobacco use one or more times within 24
months AND who received cessation counseling
intervention if identified as a tobacco user.
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Table 35--Proposed General Surgery Measures Group for 2015 and Beyond
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0419/130................. Documentation of Current Medications in the CMS/QIP
Medical Record: Percentage of visits for
patients aged 18 years and older for which the
eligible professional attests to documenting a
list of current medications using all immediate
resources available on the date of the
encounter. This list must include ALL known
prescriptions, over-the-counters, herbals, and
vitamin/mineral/dietary (nutritional)
supplements AND must contain the medications'
name, dosage, frequency and route of
administration.
0028/226................. Preventive Care and Screening: Tobacco Use: AMA-PCPI
Screening and Cessation Intervention: Percentage
of patients 18 years and older who were screened
for tobacco use one or more times within 24
months AND who received cessation counseling
intervention if identified as a tobacco user.
N/A/354.................. Anastomotic Leak Intervention: Percentage of ACS
patients aged 18 years and older who required an
anastomotic leak intervention following gastric
bypass or colectomy surgery.
N/A/355.................. Unplanned Reoperation within the 30 Day ACS
Postoperative Period: Percentage of patients
aged 18 years and older who had any unplanned
reoperation within the 30 day postoperative
period.
N/A/356.................. Unplanned Hospital Readmission within 30 Days of ACS
Principal Procedure: Percentage of patients aged
18 years and older who had an unplanned hospital
readmission within 30 days of principal
procedure.
N/A/357.................. Surgical Site Infection (SSI): Percentage of ACS
patients aged 18 years and older who had a
surgical site infection (SSI).
N/A/358.................. Patient-Centered Surgical Risk Assessment and ACS
Communication: Percentage of patients who
underwent a non-emergency surgery who had their
personalized risks of postoperative
complications assessed by their surgical team
prior to surgery using a clinical data-based,
patient-specific risk calculator and who
received personal discussion of those risks with
the surgeon.
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Table 36--Proposed Heart Failure (HF) Measures Group for 2015 and Beyond
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0081/005.................... Heart Failure (HF): Angiotensin-Converting Enzyme AMA-PCPI/ACCF/AHA
(ACE) Inhibitor or Angiotensin Receptor Blocker
(ARB) Therapy for Left Ventricular Systolic
Dysfunction (LVSD): Percentage of patients aged 18
years and older with a diagnosis of heart failure
(HF) with a current or prior left ventricular
ejection fraction (LVEF) < 40% who were prescribed
ACE inhibitor or ARB therapy either within a 12
month period when seen in the outpatient setting OR
at each hospital discharge.
0083/008.................... Heart Failure (HF): Beta-Blocker Therapy for Left AMA-PCPI/ACCF/AHA
Ventricular Systolic Dysfunction (LVSD): Percentage
of patients aged 18 years and older with a
diagnosis of heart failure (HF) with a current or
prior left ventricular ejection fraction (LVEF) <
40% who were prescribed beta-blocker therapy either
within a 12 month period when seen in the
outpatient setting OR at each hospital discharge.
0326/047.................... Care Plan: Percentage of patients aged 65 years and AMA-PCPI/NCQA
older who have an care plan or surrogate decision
maker documented in the medical record or
documentation in the medical record that an care
plan was discussed but the patient did not wish or
was not able to name a surrogate decision maker or
provide an care plan.
0041/110.................... Preventive Care and Screening: Influenza AMA-PCPI
Immunization: Percentage of patients aged 6 months
and older seen for a visit between October 1 and
March 31 who received an influenza immunization OR
who reported previous receipt of an influenza
immunization.
0419/130.................... Documentation of Current Medications in the Medical CMS/QIP
Record: Percentage of visits for patients aged 18
years and older for which the eligible professional
attests to documenting a list of current
medications using all immediate resources available
on the date of the encounter. This list must
include ALL known prescriptions, over-the-counters,
herbals, and vitamin/mineral/dietary (nutritional)
supplements AND must contain the medications' name,
dosage, frequency and route of administration.
0028/226.................... Preventive Care and Screening: Tobacco Use: AMA-PCPI
Screening and Cessation Intervention: Percentage of
patients 18 years and older who were screened for
tobacco use one or more times within 24 months AND
who received cessation counseling intervention if
identified as a tobacco user.
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[[Page 40463]]
Table 37--Proposed Hepatitis C Measures Group for 2015 and Beyond
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0395/084................. Hepatitis C: Ribonucleic Acid (RNA) Testing AMA-PCPI
Before Initiating Treatment: Percentage of
patients aged 18 years and older with a
diagnosis of chronic hepatitis C who started
antiviral treatment within the 12 month
reporting period for whom quantitative hepatitis
C virus (HCV) RNA testing was performed within
12 months prior to initiation of antiviral
treatment.
0396/085................. Hepatitis C: HCV Genotype Testing Prior to AMA-PCPI
Treatment: Percentage of patients aged 18 years
and older with a diagnosis of chronic hepatitis
C who started antiviral treatment within the 12
month reporting period for whom hepatitis C
virus (HCV) genotype testing was performed
within 12 months prior to initiation of
antiviral treatment.
0398/087................. Hepatitis C: Hepatitis C Virus (HCV) Ribonucleic AMA-PCPI
Acid (RNA) Testing Between 4-12 Weeks After
Initiation of Treatment: Percentage of patients
aged 18 years and older with a diagnosis of
chronic hepatitis C who are receiving antiviral
treatment for whom quantitative hepatitis C
virus (HCV) RNA testing was performed between 4-
12 weeks after the initiation of antiviral
treatment.
0419/130................. Documentation of Current Medications in the CMS/QIP
Medical Record: Percentage of visits for
patients aged 18 years and older for which the
eligible professional attests to documenting a
list of current medications using all immediate
resources available on the date of the
encounter. This list must include ALL known
prescriptions, over-the-counters, herbals, and
vitamin/mineral/dietary (nutritional)
supplements AND must contain the medications'
name, dosage, frequency and route of
administration.
0399/183................. Hepatitis C: Hepatitis A Vaccination in Patients AMA-PCPI
with Hepatitis C Virus (HCV): Percentage of
patients aged 18 years and older with a
diagnosis of chronic hepatitis C who have
received at least one injection of hepatitis A
vaccine, or who have documented immunity to
hepatitis A.
0028/226................. Preventive Care and Screening: Tobacco Use: AMA-PCPI
Screening and Cessation Intervention: Percentage
of patients 18 years and older who were screened
for tobacco use one or more times within 24
months AND who received cessation counseling
intervention if identified as a tobacco user.
N/A/N/A.................. Screening for Hepatocellular Carcinoma (HCC) in AGA/AASLD/AMA-PCPI
patients with Hepatitis C Cirrhosis: Percentage
of patients aged 18 years and older with a
diagnosis of chronic hepatitis C cirrhosis who
were screened with either ultrasound, triple-
contrast CT or triple-contrast MRI for
hepatocellular carcinoma (HCC) at least once
within the 12 month reporting period.
N/A/N/A.................. Discussion and Shared Decision Making Surrounding AGA/AASLD/AMA-PCPI
Treatment Options: Percentage of patients aged
18 years and older with a diagnosis of hepatitis
C with whom a physician or other clinician
reviewed the range of treatment options
appropriate to their genotype and demonstrated a
shared decision making approach with the
patient. To meet the measure, there must be
documentation in the patient record of a
discussion between the physician/clinician and
the patient that includes all of the following:
Treatment choices appropriate to
genotype.
Risks and benefits......................
Evidence of effectiveness...............
Patient preferences toward the outcome
of the treatment.
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Table 38--Proposed HIV/AIDS Measures Group for 2015 and Beyond
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0326/047................. Care Plan: Percentage of patients aged 65 years AMA-PCPI/NCQA
and older who have an care plan or surrogate
decision maker documented in the medical record
or documentation in the medical record that an
care plan was discussed but the patient did not
wish or was not able to name a surrogate
decision maker or provide an care plan.
0418/134................. Preventive Care and Screening: Screening for CMS/QIP
Clinical Depression and Follow-Up Plan:
Percentage of patients aged 12 years and older
screened for clinical depression on the date of
the encounter using an age appropriate
standardized depression screening tool AND if
positive, a follow-up plan is documented on the
date of the positive screen.
0405/160................. HIV/AIDS: Pneumocystis Jiroveci Pneumonia (PCP) NCQA
Prophylaxis: Percentage of patients aged 6 weeks
and older with a diagnosis of HIV/AIDS who were
prescribed Pneumocystis Jiroveci Pneumonia (PCP)
prophylaxis.
0409/205................. HIV/AIDS: Sexually Transmitted Disease Screening AMA-PCPI/NCQA
for Chlamydia, Gonorrhea, and Syphilis:
Percentage of patients aged 13 years and older
with a diagnosis of HIV/AIDS for whom chlamydia,
gonorrhea and syphilis screenings were performed
at least once since the diagnosis of HIV
infection.
0028/226................. Preventive Care and Screening: Tobacco Use: AMA-PCPI
Screening and Cessation Intervention: Percentage
of patients aged 18 years and older who were
screened for tobacco use one or more times
within 24 months AND who received cessation
counseling intervention if identified as a
tobacco user.
2082/338................. HIV Viral Load Suppression: The percentage of HRSA
patients, regardless of age, with a diagnosis of
HIV with a HIV viral load less than 200 copies/
mL at last HIV viral load test during the
measurement year.
2083/339................. Prescription of HIV Antiretroviral Therapy: HRSA
Percentage of patients, regardless of age, with
a diagnosis of HIV prescribed antiretroviral
therapy for the treatment of HIV infection
during the measurement year.
2079/340................. HIV Medical Visit Frequency: Percentage of HRSA
patients, regardless of age with a diagnosis of
HIV who had at least one medical visit in each 6
month period of the 24 month measurement period,
with a minimum of 60 days between medical visits.
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[[Page 40464]]
Table 39--Proposed Inflammatory Bowel Disease (IBD) Measures Group for 2015 and Beyond
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0028/226................. Preventive Care and Screening: Tobacco Use: AMA-PCPI
Screening and Cessation Intervention: Percentage
of patients 18 years and older who were screened
for tobacco use one or more times within 24
months AND who received cessation counseling
intervention if identified as a tobacco user.
N/A/270.................. Inflammatory Bowel Disease (IBD): Preventive AGA
Care: Corticosteroid Sparing Therapy: Percentage
of patients aged 18 years and older with a
diagnosis of inflammatory bowel disease who have
been managed by corticosteroids greater than or
equal to 10 mg/day for 60 or greater consecutive
days that have been prescribed corticosteroid
sparing therapy in the last reporting year.
N/A/271.................. Inflammatory Bowel Disease (IBD): Preventive AGA
Care: Corticosteroid Related Iatrogenic Injury--
Bone Loss Assessment: Percentage of patients
aged 18 years and older with a diagnosis of
inflammatory bowel disease who have received
dose of corticosteroids greater than or equal to
10 mg/day for 60 or greater consecutive days and
were assessed for risk of bone loss once per the
reporting year.
0041/110................. Preventive Care and Screening: Influenza AMA-PCPI
Immunization: Percentage of patients aged 6
months and older seen for a visit between
October 1 and March 31 who received an influenza
immunization OR who reported previous receipt of
an influenza immunization.
0043/111................. Pneumonia Vaccination Status for Older Adults: NCQA
Percentage of patients 65 years of age and older
who have ever received a pneumococcal vaccine.
N/A/274.................. Inflammatory Bowel Disease (IBD): Testing for AGA
Latent Tuberculosis (TB) Before Initiating Anti-
TNF (Tumor Necrosis Factor) Therapy: Percentage
of patients aged 18 years and older with a
diagnosis of inflammatory bowel disease for whom
a tuberculosis (TB) screening was performed and
results interpreted within 6 months prior to
receiving a first course of anti-TNF (tumor
necrosis factor) therapy.
N/A/275.................. Inflammatory Bowel Disease (IBD): Assessment of AGA
Hepatitis B Virus (HBV) Status Before Initiating
Anti-TNF (Tumor Necrosis Factor) Therapy:
Percentage of patients aged 18 years and older
with a diagnosis of inflammatory bowel disease
(IBD) who had Hepatitis B Virus (HBV) status
assessed and results interpreted within 1 year
prior to receiving a first course of anti-TNF
(tumor necrosis factor) therapy.
----------------------------------------------------------------------------------------------------------------
Table 40--Proposed Oncology Measures Group for 2015 and Beyond
----------------------------------------------------------------------------------------------------------------
NQF/ PQRS Measure title and description Measure developer
----------------------------------------------------------------------------------------------------------------
0387/071..................... Breast Cancer: Hormonal Therapy for Stage IC-IIIC AMA-PCPI/ASCO/NCCN
Estrogen Receptor/Progesterone Receptor (ER/PR)
Positive Breast Cancer: Percentage of female
patients aged 18 years and older with Stage IC
through IIIC, ER or PR positive breast cancer who
were prescribed tamoxifen or aromatase inhibitor
(AI) during the 12-month reporting period.
0385/072..................... Colon Cancer: Chemotherapy for AJCC Stage III Colon AMA-PCPI/ASCO/NCCN
Cancer Patients: Percentage of patients aged 18
through 80 years with AJCC Stage III colon cancer
who are referred for adjuvant chemotherapy,
prescribed adjuvant chemotherapy, or have
previously received adjuvant chemotherapy within
the 12-month reporting period.
0041/110..................... Preventive Care and Screening: Influenza AMA-PCPI
Immunization: Percentage of patients aged 6 months
and older seen for a visit between October 1 and
March 31 who received an influenza immunization OR
who reported previous receipt of an influenza
immunization.
0419/130..................... Documentation of Current Medications in the Medical CMS/QIP
Record: Percentage of visits for patients aged 18
years and older for which the eligible professional
attests to documenting a list of current
medications using all immediate resources available
on the date of the encounter. This list must
include ALL known prescriptions, over-the-counters,
herbals, and vitamin/mineral/dietary (nutritional)
supplements AND must contain the medications' name,
dosage, frequency and route of administration.
0384/143..................... Oncology: Medical and Radiation--Pain Intensity AMA-PCPI
Quantified: Percentage of patients, regardless of
patient age, with a diagnosis of cancer currently
receiving chemotherapy or radiation therapy in
which pain intensity is quantified.
0383/144..................... Oncology: Medical and Radiation--Plan of Care for AMA-PCPI
Pain: Percentage of visits for patients, regardless
of age, with a diagnosis of cancer currently
receiving chemotherapy or radiation therapy who
report having pain with a documented plan of care
to address pain.
0028/226..................... Preventive Care and Screening: Tobacco Use: AMA-PCPI
Screening and Cessation Intervention: Percentage of
patients 18 years and older who were screened for
tobacco use one or more times within 24 months AND
who received cessation counseling intervention if
identified as a tobacco user.
----------------------------------------------------------------------------------------------------------------
Table 41--Proposed Optimizing Patient Exposure to Ionizing Radiation
Measures Group for 2015 and Beyond
------------------------------------------------------------------------
Measure title and
NQF/ PQRS description Measure developer
------------------------------------------------------------------------
N/A/359........... Optimizing Patient AMA-PCPI
Exposure to Ionizing
Radiation:
Utilization of a
Standardized
Nomenclature for
Computed Tomography
(CT) Imaging
Description:
Percentage of
computed tomography
(CT) imaging reports
for all patients,
regardless of age,
with the imaging
study named according
to a standardized
nomenclature and the
standardized
nomenclature is used
in institution's
computer systems.
[[Page 40465]]
N/A/360........... Optimizing Patient AMA-PCPI
Exposure to Ionizing
Radiation: Count of
Potential High Dose
Radiation Imaging
Studies: Computed
Tomography (CT) and
Cardiac Nuclear
Medicine Studies:
Percentage of
computed tomography
(CT) and cardiac
nuclear medicine
(myocardial perfusion
studies) imaging
reports for all
patients, regardless
of age, that document
a count of known
previous CT (any type
of CT) and cardiac
nuclear medicine
(myocardial
perfusion) studies
that the patient has
received in the 12-
month period prior to
the current study.
N/A/361........... Optimizing Patient AMA-PCPI
Exposure to Ionizing
Radiation: Reporting
to a Radiation Dose
Index Registry:
Percentage of total
computed tomography
(CT) studies
performed for all
patients, regardless
of age, that are
reported to a
radiation dose index
registry AND that
include at a minimum
selected data
elements.
N/A/362........... Optimizing Patient AMA-PCPI
Exposure to Ionizing
Radiation: Computed
Tomography (CT)
Images Available for
Patient Follow-up and
Comparison Purposes:
Percentage of final
reports for computed
tomography (CT)
studies performed for
all patients,
regardless of age,
which document that
Digital Imaging and
Communications in
Medicine (DICOM)
format image data are
available to non-
affiliated external
entities on a secure,
media free,
reciprocally
searchable basis with
patient authorization
for at least a 12-
month period after
the study.
N/A/363........... Optimizing Patient AMA-PCPI
Exposure to Ionizing
Radiation: Search for
Prior Computed
Tomography (CT)
Imaging Studies
Through a Secure,
Authorized, Media-
Free, Shared Archive:
Percentage of final
reports of computed
tomography (CT)
studies performed for
all patients,
regardless of age,
which document that a
search for Digital
Imaging and
Communications in
Medicine (DICOM)
format images was
conducted for prior
patient CT imaging
studies completed at
non-affiliated
external entities
within the past 12
months and are
available through a
secure, authorized,
media free, shared
archive prior to an
imaging study being
performed.
N/A/364........... Optimizing Patient AMA-PCPI
Exposure to Ionizing
Radiation:
Appropriateness:
Follow-up CT Imaging
for Incidentally
Detected Pulmonary
Nodules According to
Recommended
Guidelines:
Percentage of final
reports for CT
imaging studies of
the thorax for
patients aged 18
years and older with
documented follow-up
recommendations for
incidentally detected
pulmonary nodules
(eg, follow-up CT
imaging studies
needed or that no
follow-up is needed)
based at a minimum on
nodule size AND
patient risk factors.
------------------------------------------------------------------------
Table 42--Proposed Parkinson's Disease Measures Group for 2015 and
Beyond
------------------------------------------------------------------------
Measure title and
NQF/ PQRS description Measure developer
------------------------------------------------------------------------
0326/047.......... Care Plan: Percentage AMA-PCPI/NCQA
of patients aged 65
years and older who
have an care plan or
surrogate decision
maker documented in
the medical record or
documentation in the
medical record that
an care plan was
discussed but the
patient did not wish
or was not able to
name a surrogate
decision maker or
provide an care plan.
N/A/289........... Parkinson's Disease: AAN
Annual Parkinson's
Disease Diagnosis
Review: All patients
with a diagnosis of
Parkinson's disease
who had an annual
assessment including
a review of current
medications (e.g.,
medications that can
produce Parkinson-
like signs or
symptoms) and a
review for the
presence of atypical
features (e.g., falls
at presentation and
early in the disease
course, poor response
to levodopa, symmetry
at onset, rapid
progression [to Hoehn
and Yahr stage 3 in 3
years], lack of
tremor or
dysautonomia) at
least annually.
N/A/290........... Parkinson's Disease: AAN
Psychiatric Disorders
or Disturbances
Assessment: All
patients with a
diagnosis of
Parkinson's disease
who were assessed for
psychiatric disorders
or disturbances
(e.g., psychosis,
depression, anxiety
disorder, apathy, or
impulse control
disorder) at least
annually.
N/A/291........... Parkinson's Disease: AAN
Cognitive Impairment
or Dysfunction
Assessment: All
patients with a
diagnosis of
Parkinson's disease
who were assessed for
cognitive impairment
or dysfunction at
least annually.
N/A/292........... Parkinson's Disease: AAN
Querying about Sleep
Disturbances: All
patients with a
diagnosis of
Parkinson's disease
(or caregivers, as
appropriate) who were
queried about sleep
disturbances at least
annually.
N/A/293........... Parkinson's Disease: AAN
Rehabilitative
Therapy Options: All
patients with a
diagnosis of
Parkinson's disease
(or caregiver(s), as
appropriate) who had
rehabilitative
therapy options
(e.g., physical,
occupational, or
speech therapy)
discussed at least
annually.
N/A/294........... Parkinson's Disease: AAN
Parkinson's Disease
Medical and Surgical
Treatment Options
Reviewed: All
patients with a
diagnosis of
Parkinson's disease
(or caregiver(s), as
appropriate) who had
the Parkinson's
disease treatment
options (e.g., non-
pharmacological
treatment,
pharmacological
treatment, or
surgical treatment)
reviewed at least
once annually.
------------------------------------------------------------------------
Table 43--Proposed Preventive Care Measures Group for 2015 and Beyond
------------------------------------------------------------------------
Measure title and
NQF/ PQRS description Measure developer
------------------------------------------------------------------------
0046/039.......... Screening or Therapy AMA-PCPI/NCQA
for Osteoporosis for
Women Aged 65 Years
and Older: Percentage
of female patients
aged 65 years and
older who have a
central dual-energy X-
ray absorptiometry
(DXA) measurement
ordered or performed
at least once since
age 60 or
pharmacologic therapy
prescribed within 12
months.
[[Page 40466]]
0098/48........... Urinary Incontinence: AMA-PCPI/NCQA
Assessment of
Presence or Absence
of Urinary
Incontinence in Women
Aged 65 Years and
Older: Percentage of
female patients aged
65 years and older
who were assessed for
the presence or
absence of urinary
incontinence within
12 months.
0041/110.......... Preventive Care and AMA-PCPI
Screening: Influenza
Immunization:
Percentage of
patients aged 6
months and older seen
for a visit between
October 1 and March
31 who received an
influenza
immunization OR who
reported previous
receipt of an
influenza
immunization.
0043/111.......... Pneumonia Vaccination NCQA
Status for Older
Adults: Percentage of
patients 65 years of
age and older who
have ever received a
pneumococcal vaccine.
N/A/112........... Breast Cancer NCQA
Screening: Percentage
of women 50 through
74 years of age who
had a mammogram to
screen for breast
cancer within 27
months.
0034/113.......... Colorectal Cancer NCQA
Screening: Percentage
of patients 50
through 75 years of
age who had
appropriate screening
for colorectal cancer.
0421/128.......... Preventive Care and CMS/QIP
Screening: Body Mass
Index (BMI) Screening
and Follow-Up:
Percentage of
patients aged 18
years and older with
a documented BMI
during the current
encounter or during
the previous 6 months
AND when the BMI is
outside of normal
parameters, a follow-
up plan is documented
during the encounter
or during the
previous 6 months of
the encounter.
Normal Parameters: Age
65 years and older
BMI >= 23 and < 30;
Age 18-64 years BMI
>= 18.5 and < 25.
0418/134.......... Preventive Care and CMS/QIP
Screening: Screening
for Clinical
Depression and Follow-
Up Plan: Percentage
of patients aged 12
years and older
screened for clinical
depression on the
date of the encounter
using an age
appropriate
standardized
depression screening
tool AND if positive,
a follow-up plan is
documented on the
date of the positive
screen.
0028/226.......... Preventive Care and AMA-PCPI
Screening: Tobacco
Use: Screening and
Cessation
Intervention:
Percentage of
patients 18 years and
older who were
screened for tobacco
use one or more times
within 24 months AND
who received
cessation counseling
intervention if
identified as a
tobacco user.
------------------------------------------------------------------------
Table 44--Proposed Rheumatoid Arthritis (RA) Measures Group for 2015 and
Beyond
------------------------------------------------------------------------
Measure title and
NQF/ PQRS description Measure developer
------------------------------------------------------------------------
0054/108.......... Rheumatoid Arthritis NCQA
(RA): Disease
Modifying Anti-
Rheumatic Drug
(DMARD) Therapy:
Percentage of
patients aged 18
years and older who
were diagnosed with
RA and were
prescribed,
dispensed, or
administered at least
one ambulatory
prescription for a
DMARD.
0041/110.......... Preventive Care and AMA-PCPI
Screening: Influenza
Immunization:
Percentage of
patients aged 6
months and older seen
for a visit between
October 1 and March
31 who received an
influenza
immunization OR who
reported previous
receipt of an
influenza
immunization.
N/A/176........... Rheumatoid Arthritis AMA-PCPI
(RA): Tuberculosis
Screening: Percentage
of patients aged 18
years and older with
a diagnosis of
rheumatoid arthritis
(RA) who have
documentation of a
tuberculosis (TB)
screening performed
and results
interpreted within 6
months prior to
receiving a first
course of therapy
using a biologic
disease-modifying
anti-rheumatic drug
(DMARD).
N/A/177........... Rheumatoid Arthritis AMA-PCPI
(RA): Periodic
Assessment of Disease
Activity: Percentage
of patients aged 18
years and older with
a diagnosis of
rheumatoid arthritis
(RA) who have an
assessment and
classification of
disease activity
within 12 months.
N/A/178........... Rheumatoid Arthritis AMA-PCPI
(RA): Functional
Status Assessment:
Percentage of
patients aged 18
years and older with
a diagnosis of
rheumatoid arthritis
(RA) for whom a
functional status
assessment was
performed at least
once within 12 months.
N/A/179........... Rheumatoid Arthritis AMA-PCPI
(RA): Assessment and
Classification of
Disease Prognosis:
Percentage of
patients aged 18
years and older with
a diagnosis of
rheumatoid arthritis
(RA) who have an
assessment and
classification of
disease prognosis at
least once within 12
months.
N/A/180........... Rheumatoid Arthritis AMA-PCPI
(RA): Glucocorticoid
Management:
Percentage of
patients aged 18
years and older with
a diagnosis of
rheumatoid arthritis
(RA) who have been
assessed for
glucocorticoid use
and, for those on
prolonged doses of
prednisone >=10 mg
daily (or equivalent)
with improvement or
no change in disease
activity,
documentation of
glucocorticoid
management plan
within 12 months.
0028/226.......... Preventive Care and AMA-PCPI
Screening: Tobacco
Use: Screening and
Cessation
Intervention:
Percentage of
patients 18 years and
older who were
screened for tobacco
use one or more times
within 24 months AND
who received
cessation counseling
intervention if
identified as a
tobacco user.
------------------------------------------------------------------------
TAble 45--Proposed Sinusitis Measures Group for 2015 and Beyond
------------------------------------------------------------------------
Measure title and
NQF/PQRS description Measure developer
------------------------------------------------------------------------
0419/130.......... Documentation of CMS/QIP
Current Medications
in the Medical
Record: Percentage of
visits for patients
aged 18 years and
older for which the
eligible professional
attests to
documenting a list of
current medications
using all immediate
resources available
on the date of the
encounter. This list
must include ALL
known prescriptions,
over-the-counters,
herbals, and vitamin/
mineral/dietary
(nutritional)
supplements AND must
contain the
medications' name,
dosage, frequency and
route of
administration..
0420/131.......... Pain Assessment and CMS/QIP
Follow-Up: Percentage
of visits for
patients aged 18
years and older with
documentation of a
pain assessment using
a standardized
tool(s) on each visit
AND documentation of
a follow-up plan when
pain is present.
[[Page 40467]]
0028/226.......... Preventive Care and AMA-PCPI
Screening: Tobacco
Use: Screening and
Cessation
Intervention:
Percentage of
patients 18 years and
older who were
screened for tobacco
use one or more times
within 24 months AND
who received
cessation counseling
intervention if
identified as a
tobacco user.
N/A/331........... Adult Sinusitis: AMA-PCPI
Antibiotic Prescribed
for Acute Sinusitis
(Appropriate Use):
Percentage of
patients, aged 18
years and older, with
a diagnosis of acute
sinusitis who were
prescribed an
antibiotic within 7
days of diagnosis or
within 10 days after
onset of symptoms.
N/A/332........... Adult Sinusitis: AMA-PCPI
Appropriate Choice of
Antibiotic:
Amoxicillin
Prescribed for
Patients with Acute
Bacterial Sinusitis:
Percentage of
patients aged 18
years and older with
a diagnosis of acute
bacterial sinusitis
that were prescribed
amoxicillin, without
clavulante, as a
first line antibiotic
at the time of
diagnosis.
N/A/333........... Adult Sinusitis: AMA-PCPI
Computerized
Tomography for Acute
Sinusitis (Overuse):
Percentage of
patients aged 18
years and older with
a diagnosis of acute
sinusitis who had a
computerized
tomography (CT) scan
of the paranasal
sinuses ordered at
the time of diagnosis
or received within 28
days after date of
diagnosis.
------------------------------------------------------------------------
Table 46--Proposed Sleep Apnea Measures Group for 2015 and Beyond
[Please note that we are proposing to remove this measure group
contingent on the measure steward not being able to maintain certain
measures contained in these measures group. If a measure steward is able
to maintain ownership of these measures, we plan to keep this measures
group in the PQRS measure set. This Table Q26 indicates the measures
that we propose will be available in this measures group should we keep
this measures group in the PQRS measure set]
------------------------------------------------------------------------
Measure title and
NQF/PQRS description Measure developer
------------------------------------------------------------------------
0421/128.......... Preventive Care and CMS/QIP
Screening: Body Mass
Index (BMI) Screening
and Follow-Up:
Percentage of
patients aged 18
years and older with
a documented BMI
during the current
encounter or during
the previous 6 months
AND when the BMI is
outside of normal
parameters, a follow-
up plan is documented
during the encounter
or during the
previous 6 months of
the encounter.
Normal Parameters: Age
65 years and older
BMI >= 23 and < 30;
Age 18-64 years BMI
>= 18.5 and < 25.
0419/130.......... Documentation of CMS/QIP
Current Medications
in the Medical
Record: Percentage of
visits for patients
aged 18 years and
older for which the
eligible professional
attests to
documenting a list of
current medications
using all immediate
resources available
on the date of the
encounter. This list
must include ALL
known prescriptions,
over-the-counters,
herbals, and vitamin/
mineral/dietary
(nutritional)
supplements AND must
contain the
medications' name,
dosage, frequency and
route of
administration.
0028/226.......... Preventive Care and AMA-PCPI
Screening: Tobacco
Use: Screening and
Cessation
Intervention:
Percentage of
patients 18 years and
older who were
screened for tobacco
use one or more times
within 24 months AND
who received
cessation counseling
intervention if
identified as a
tobacco user.
N/A/276........... Sleep Apnea: AMA-PCPI/NCQA
Assessment of Sleep
Symptoms: Percentage
of visits for
patients aged 18
years and older with
a diagnosis of
obstructive sleep
apnea that includes
documentation of an
assessment of sleep
symptoms, including
presence or absence
of snoring and
daytime sleepiness.
N/A/277........... Sleep Apnea: Severity AMA-PCPI/NCQA
Assessment at Initial
Diagnosis: Percentage
of patients aged 18
years and older with
a diagnosis of
obstructive sleep
apnea who had an
apnea hypopnea index
(AHI) or a
respiratory
disturbance index
(RDI) measured at the
time of initial
diagnosis.
N/A/278........... Sleep Apnea: Positive AMA-PCPI/NCQA
Airway Pressure
Therapy Prescribed:
Percentage of
patients aged 18
years and older with
a diagnosis of
moderate or severe
obstructive sleep
apnea who were
prescribed positive
airway pressure
therapy.
N/A/279........... Sleep Apnea: AMA-PCPI/NCQA
Assessment of
Adherence to Positive
Airway Pressure
Therapy: Percentage
of visits for
patients aged 18
years and older with
a diagnosis of
obstructive sleep
apnea who were
prescribed positive
airway pressure
therapy who had
documentation that
adherence to positive
airway pressure
therapy was
objectively measured.
------------------------------------------------------------------------
Table 47--Proposed Total Knee Replacement (TKR) Measures Group for 2015
and Beyond
------------------------------------------------------------------------
Measure title and
NQF/PQRS description Measure developer
------------------------------------------------------------------------
0419/130.......... Documentation of CMS/QIP
Current Medications
in the Medical
Record: Percentage of
visits for patients
aged 18 years and
older for which the
eligible professional
attests to
documenting a list of
current medications
using all immediate
resources available
on the date of the
encounter. This list
must include ALL
known prescriptions,
over-the-counters,
herbals, and vitamin/
mineral/dietary
(nutritional)
supplements AND must
contain the
medications' name,
dosage, frequency and
route of
administration.
0028/226.......... Preventive Care and AMA-PCPI
Screening: Tobacco
Use: Screening and
Cessation
Intervention:
Percentage of
patients 18 years and
older who were
screened for tobacco
use one or more times
within 24 months AND
who received
cessation counseling
intervention if
identified as a
tobacco user.
N/A/350........... Total Knee AAHKS
Replacement: Shared
Decision-Making:
Trial of Conservative
(Non-surgical)
Therapy: Percentage
of patients
regardless of age or
gender undergoing a
total knee
replacement with
documented shared
decision-making with
discussion of
conservative (non-
surgical) therapy
prior to the
procedure.
N/A/351........... Total Knee AAHKS
Replacement: Venous
Thromboembolic and
Cardiovascular Risk
Evaluation:
Percentage of
patients regardless
of age or gender
undergoing a total
knee replacement who
are evaluated for the
presence or absence
of venous
thromboembolic and
cardiovascular risk
factors within 30
days prior to the
procedure including
history of Deep Vein
Thrombosis, Pulmonary
Embolism, Myocardial
Infarction,
Arrhythmia and Stroke.
[[Page 40468]]
N/A/352........... Total Knee AAHKS
Replacement:
Preoperative
Antibiotic Infusion
with Proximal
Tourniquet:
Percentage of
patients regardless
of age undergoing a
total knee
replacement who had
the prophylactic
antibiotic completely
infused prior to the
inflation of the
proximal tourniquet.
N/A/353........... Total Knee AAHKS
Replacement:
Identification of
Implanted Prosthesis
in Operative Report:
Percentage of
patients regardless
of age or gender
undergoing total knee
replacement whose
operative report
identifies the
prosthetic implant
specifications
including the
prosthetic implant
manufacturer, the
brand name of the
prosthetic implant
and the size of
prosthetic implant.
------------------------------------------------------------------------
e. Proposals for Measures Available for Reporting in the GPRO Web
Interface
We finalized the measures that are available for reporting in the
GPRO Web interface for 2014 and beyond in the CY 2013 PFS final rule
(77 FR 69269). However, we are proposing to remove and add measures in
the GPRO Web interface measure set as reflected in Tables 47 and 48 for
2015 and beyond. Specifically, Table 47 specifies the measures we are
proposing to remove for reporting from the GPRO Web interface, and
Table 48 specifies the measures we are proposing to add for reporting
in the GPRO Web interface. CMS is proposing to adopt Depression
Remission at Twelve Months (NQF 0710) in the 2015 GPRO Web
Interface reporting option for ACOs and group practices. This measure
is currently reportable in the PQRS program through the EHR reporting
option only and has not been tested using claims level data or sampling
methodology. Depression Remission at Twelve Months (NQF 0710)
requires a look-back period and a look-forward period possibly spanning
multiple calendar years. Additionally, this measure requires
utilization of a PHQ-9 depression screening tool with a score greater
than 9 and a diagnosis of depression/dysthymia to identify the
beginning of the episode (initial patient population). Successful
completion of the quality action for this measure looks for a PHQ-9
score of less than 5 at the twelve month mark (plus or minus 30 days)
from the initial onset of the episode. CMS is soliciting comments
regarding this proposal, including operational concerns and the
technical feasibility for implementation in the 2015 GPRO Web
Interface. We note that, in addition to addressing changes in evidence-
based practices, we are modifying the GPRO Web interface in an effort
to align with the proposed measure changes in the Medicare Shared
Savings Program specified in section III.M.
BILLING CODE 4120-01-P
[[Page 40469]]
[GRAPHIC] [TIFF OMITTED] TP11JY14.062
[[Page 40470]]
[GRAPHIC] [TIFF OMITTED] TP11JY14.063
[[Page 40471]]
[GRAPHIC] [TIFF OMITTED] TP11JY14.064
[[Page 40472]]
[GRAPHIC] [TIFF OMITTED] TP11JY14.065
BILLING CODE 4120-01-C
Please note that, if these proposals are finalized, the GPRO
measure set will contain 21 measures available for reporting.
f. The Clinician Group (CG) Consumer Assessment of Healthcare Providers
and Systems (CAHPS) Survey
In the CY 2014 PFS final rule with comment period, we finalized the
CG-CAHPS survey available for reporting under the PQRS for 2014 and
beyond (78 FR 74750 through 74751), to which we are now referring as
the CAHPS for PQRS. Please note that, in the CY 2014 PFS final rule
with comment period, we classified the CAHPS for PQRS survey under the
care coordination and communication NQS domain. We note that this was
an error on our part, as the CAHPS for PQRS survey has typically been
classified under the Person and Caregiver-Centered Experience and
Outcomes domain as the CAHPS for PQRS survey assesses beneficiary
experience of care and outcomes. Therefore, as we indicate in Table 21,
we are proposing to reclassify the CAHPS for PQRS survey under the
Person and Caregiver-Centered Experience and Outcomes domain. We invite
public comment on this proposal.
6. Statutory Requirements and Other Considerations for the Selection of
PQRS Quality Measures for Meeting the Criteria for Satisfactory
Participation in a QCDR for 2014 and Beyond for Individual Eligible
Professionals
For the measures which eligible professionals participating in a
QCDR must report, section 1848(m)(3)(D) of the Act, as amended and
added by section 601(b) of the ATRA, provides that the Secretary shall
treat eligible professionals as satisfactorily submitting data on
quality measures if they satisfactorily participate in a QCDR. Section
1848(m)(3)(E) of the Act, as added by section 601(b) of the ATRA,
provides some flexibility with regard to the types of measures
applicable to satisfactory participation in a QCDR, by specifying that
for measures used by a QCDR, sections 1890(b)(7) and 1890A(a) of the
Act shall not apply, and measures endorsed by the entity with a
contract with the Secretary under section 1890(a) of the Act may be
used.
In the CY 2014 PFS final rule with comment period, we finalized
requirements related to the parameters for the measures that would have
to be reported to CMS by a QCDR for the purpose of its individual
eligible
[[Page 40473]]
professionals meeting the criteria for satisfactory participation under
the PQRS (78 FR 74751 through 74753). Although we are not proposing to
remove any of the requirements we finalized related to these
parameters, we are proposing to modify the following parameters we
finalized in the CY 2014 PFS final rule with comment period related to
measures that may be reported by a QCDR:
The QCDR must have at least 1 outcome measure available
for reporting, which is a measure that assesses the results of health
care that are experienced by patients (that is, patients' clinical
events; patients' recovery and health status; patients' experiences in
the health system; and efficiency/cost).
As we are proposing that for an eligible professional to meet the
criterion for satisfactory participation in a QCDR for the 2017 PQRS
payment adjustment, the eligible professional must report on at least 3
outcome measures or, in lieu of 3 outcome measures, at least 2 outcome
measures and 1 resource use, patient experience of care, or efficiency/
appropriate use measure, we are modifying this requirement to conform
to this proposed satisfactory participation criterion. Therefore, we
are proposing that a QCDR must have at least 3 outcome measures
available for reporting, which is a measure that assesses the results
of health care that are experienced by patients (that is, patients'
clinical events; patients' recovery and health status; patients'
experiences in the health system; and efficiency/cost). In lieu of
having 3 outcome measures available for reporting, the QCDR must have
at least 2 outcome measures available for reporting and at least 1
resource use, patient experience of care, or efficiency/appropriate use
measure.
We are proposing to define resource use, patient experience of
care, or efficiency/appropriate use measures in the following manner:
A resource use measure is a measure that is a comparable
measure of actual dollars or standardized units of resources applied to
the care given to a specific population or event, such as a specific
diagnosis, procedure, or type of medical encounter.
A patient experience of care measure is a measure of
person- or family-reported experiences (outcomes) of being engaged as
active members of the health care team and in collaborative
partnerships with providers and provider organizations.
An efficiency/appropriate use measure is a measure of the
appropriate use of health care services (such as diagnostics or
therapeutics) based upon evidence-based guidelines of care, or for
which the potential for harm exceeds the possible benefits of care.
Please note that, for purposes of meeting the criteria for
satisfactory participation in a QCDR, we allow QCDRs to report on any
measure provided that it meets the measure parameters we finalize. We
note that we would allow and encourage the reporting of the Consumer
Assessment of Healthcare Providers Surgical Care Survey (S-CAHPS)
through a QCDR.
Finally, in the CY 2014 PFS final rule with comment period, we
stated that a QCDR must provide to CMS descriptions and narrative
specifications for the measures for which it will report to CMS by no
later than March 31, 2014. In keeping with this timeframe, we propose
that a QCDR must provide to CMS descriptions for the measures for which
it will report to CMS for a particular year by no later than March 31
of the applicable reporting period for which the QCDR wishes to submit
quality measures data. For example, if a QCDR wishes to submit quality
measures data for the 2017 PQRS payment adjustment (the 12-month
reporting period of which occurs in 2015), the QCDR must provide to CMS
descriptions for the measures for which it will report to CMS by no
later than March 31, 2015. The descriptions must include: name/title of
measures, NQF (if NQF endorsed), descriptions of the
denominator, numerator, and when applicable, denominator exceptions and
denominator exclusions of the measure. The narrative specifications
provided must be similar to the narrative specifications we provide in
our measures list, available at http://www.cms.gov/apps/ama/license.asp?file=/PQRS/downloads/2014_PQRS_IndClaimsRegistry_MeasureSpecs_SupportingDocs_12132013.zip.
Related to this proposal, we propose that, 15 days following CMS
approval of these measure specifications, the QCDR must publicly post
the measures specifications for the measures it intends to report for
the PQRS using any public format it prefers. Immediately following
posting of the measures specification information, the QCDR must
provide CMS with the link to where this information is posted. CMS will
then post this information when it provides its list of QCDRs for the
year. We believe providing this information will further aide in
creating transparency of reporting.
We invite public comment on these proposals.
7. Informal Review
In the CY 2013 PFS final rule with comment period (77 FR 69289), we
established that ``an eligible professional electing to utilize the
informal review process must request an informal review by February 28
of the year in which the payment adjustment is being applied. For
example, if an eligible professional requests an informal review
related to the 2015 payment adjustment, the eligible professional would
be required to submit his/her request for an informal review by
February 28, 2015.'' As stated in the CY 2013 PFS final rule with
comment period, we believed this deadline provided ample time for
eligible professionals and group practices after their respective
claims begin to be adjusted due to the payment adjustment. However,
because PQRS data is used to establish the quality composite of the VM,
we believe it is necessary to expand the informal review process to
allow for some limited corrections of the PQRS data to be made.
Therefore, we propose to modify the payment adjustment informal review
deadline to within 30 days of the release of the feedback reports. For
example, if the feedback reports for the 2016 payment adjustment (based
on data collected for 2014 reporting periods) are released on August
31, 2015, an eligible professional or group practice would be required
to submit a request for an informal review by September 30, 2015. We
believe that by being able to notify eligible professionals and group
practices of CMS' decision on the informal review request much earlier
than we would have been able to do with the previous informal review
request deadline we can provide a brief period for an eligible or group
practice to make some limited corrections to its PQRS data. This
resubmitted data could then be used to make corrections to the VM
calculations, when appropriate.
The PQRS regulations at Sec. 414.90(m)(1) currently require an
eligible professional or group practice to submit an informal review
request to CMS within 90 days of the release of the feedback reports.
Therefore, we propose to revise Sec. 414.90(m)(1).
Regarding the eligible professional's or group practice's ability
to provide additional information to assist in the informal review
process, we propose to provide the following limitations as to what
information may be taken into consideration:
CMS would only allow resubmission of data that was
submitted using a third-party vendor using either
[[Page 40474]]
the qualified registry, EHR data submission vendor, or QCDR reporting
mechanisms. Therefore, CMS would not allow resubmission of data
submitted via claims, direct EHR, or the GPRO web interface reporting
mechanisms. We are limiting resubmission to third-party vendors,
because we believe that third-party vendors are more easily able to
detect errors than direct users.
CMS would only allow resubmission of data that was already
previously submitted to CMS. Submission of new data--such as new
measures data not previously submitted or new data for eligible
professionals for which data was not submitted during the original
submission period--would not be accepted.
For any given resubmission period, CMS would only accept
data that was previously submitted for the reporting periods for which
the corresponding informal review period applies. For example, the
resubmission period immediately following the informal review period
for the 2017 PQRS payment adjustment would only allow resubmission for
data previously submitted for the 2017 PQRS payment adjustment
reporting periods occurring in 2015.
As such, we are proposing to add Sec. 414.90(m)(3) to reflect this
proposal as follows: (3) If, during the informal review process, CMS
finds errors in data that was submitted using a third-party vendor
using either the qualified registry, EHR data submission vendor, or
QCDR reporting mechanisms, CMS may allow for the resubmission of data
to correct these errors. (i) CMS will not allow resubmission of data
submitted via claims, direct EHR, and the GPRO web interface reporting
mechanisms. (ii) CMS will only allow resubmission of data that was
already previously submitted to CMS. (iii) CMS will only accept data
that was previously submitted for the reporting periods for which the
corresponding informal review period applies.
We invite public comment on these proposals.
L. Electronic Health Record (EHR) Incentive Program
The HITECH Act (Title IV of Division B of the ARRA, together with
Title XIII of Division A of the ARRA) authorizes incentive payments
under Medicare and Medicaid for the adoption and meaningful use of
certified EHR technology (CEHRT). Section 1848(o)(2)(B)(iii) of the Act
requires that in selecting CQMs for eligible professionals (EPs) to
report under the EHR Incentive Program, and in establishing the form
and manner of reporting, the Secretary shall seek to avoid redundant or
duplicative reporting otherwise required. As such, we have taken steps
to establish alignments among various quality reporting and payment
programs that include the submission of CQMs.
For CY 2012 and subsequent years, Sec. 495.8(a)(2)(ii) requires an
EP to successfully report the clinical quality measures selected by CMS
to CMS or the states, as applicable, in the form and manner specified
by CMS or the states, as applicable.
In the CY 2014 PFS final rule with comment period (78 FR 74756), we
finalized our proposal to require EPs who seek to report CQMs
electronically under the Medicare EHR Incentive Program to use the most
recent version of the electronic specifications for the CQMs and have
CEHRT that is tested and certified to the most recent version of the
electronic specifications for the CQMs. We noted it is important for
EPs to electronically report the most recent versions of the electronic
specifications for the CQMs as updated measure versions correct minor
inaccuracies found in prior measure versions. We stated that to ensure
that CEHRT products can successfully transmit CQM data using the most
recent version of the electronic specifications for the CQMs, it is
important that the product be tested and certified to the most recent
version of the electronic specifications for the CQMs.
Since finalizing this proposal, we have received feedback from
stakeholders regarding the difficulty and expense of having to test and
recertify CEHRT products to the most recent version of the electronic
specifications for the CQMs. While we still believe EPs should test and
certify their products to the most recent version of the electronic
specifications for the CQMs when feasible, we understand the burdens
associated with this requirement. Therefore, to eliminate this added
burden, we are proposing that, beginning in CY 2015, EPs would not be
required to ensure that their CEHRT products are recertified to the
most recent version of the electronic specifications for the CQMs.
Please note that, although we are not requiring recertification, EPs
must still report the most recent version of the electronic
specifications for the CQMs.
In the CY 2014 PFS final rule with comment period, we established
the requirement that EPs who seek to report CQMs electronically under
the Medicare EHR Incentive Program must use the most recent version of
the electronic specifications for the CQMs (78 FR 74756). When
establishing this requirement, we did not account for instances where
errors are discovered in the updated electronic measure specifications.
To account for these instances and consistent with the proposal set
forth in the PQRS in section III.K, we propose that, beginning in CY
2015, if we discover errors in the most recently updated electronic
measure specifications for a certain measure, we would use the version
of electronic measure specifications that immediately precedes the most
recently updated electronic measure specifications.
Additionally, we noted that, with respect to the following measure
CMS140v2, Breast Cancer Hormonal Therapy for Stage IC-IIIC Estrogen
Receptor/Progesterone Receptor (ER/PR) Positive Breast Cancer (NQF
0387), a substantive error was discovered in the June 2013 version of
this electronically specified clinical quality measure (78 FR 74757).
If an EP chooses to report this measure electronically under the EHR
Incentive Program in CY 2014, the prior, December 2012 version of the
measure, which is CMS140v1, must be used (78 FR 74757). Since a more
recent and corrected version of this measure has been developed, we
will require the reporting of the most recent, updated version of the
measure Breast Cancer Hormonal Therapy for Stage IC-IIIC Estrogen
Receptor/Progesterone Receptor (ER/PR) Positive Breast Cancer (NQF
0387), if an EP chooses to report the measure electronically in CY
2015.
In the EHR Incentive Program Stage 2 final rule, we established CQM
reporting options for the Medicare EHR Incentive Program for CY 2014
and subsequent years that include one individual reporting option that
aligns with the PQRS's EHR reporting option (77 FR 54058) and two group
reporting options that align with the PQRS GPRO and Medicare Shared
Savings Program (MSSP) and Pioneer ACOs (77 FR 54076 to 54078). In the
CY 2014 PFS final rule with comment period, we finalized two additional
aligned options for EPs to report CQMs for the Medicare EHR Incentive
Program for CY 2014 and subsequent years with the intention of
minimizing the reporting burden on EPs (78 FR 74753 through 74757). One
of the aligned options finalized in the CY 2014 PFS final rule with
comment period (78 FR 74754 through 74755) is a reporting option for
CQMs for the Medicare EHR Incentive Program under which EPs can submit
CQM information using qualified clinical data registries, according the
definition and requirements for qualified clinical data registries
established under the PQRS.
[[Page 40475]]
The second aligned option finalized in the CY 2014 PFS final rule
with comment period (78 FR 74755 through 74756) is a group reporting
option for CQMs for the Medicare EHR Incentive Program beginning in CY
2014 under which EPs who are part of a Comprehensive Primary Care (CPC)
initiative practice site that successfully reports at least nine
electronically specified CQMs across three domains for the relevant
reporting period in accordance with the requirements established for
the CPC initiative and using CEHRT would satisfy the CQM reporting
component of meaningful use for the Medicare EHR Incentive Program. If
a CPC practice site is not successful in reporting, EPs who are part of
the site would still have the opportunity to report CQMs in accordance
with the requirements established for the Medicare EHR Incentive
Program in the Stage 2 final rule. Additionally, only those EPs who are
beyond their first year of demonstrating meaningful use may use this
CPC group reporting option. The CPC practice sites must submit the CQM
data in the form and manner required by the CPC initiative. Therefore,
whether CPC required electronic submission or attestation of CQMs, the
CPC practice site must submit the CQM data in the form and manner
required by the CPC initiative.
The CPC initiative, under the authority of section 3021 of the
Affordable Care Act, is a multi-payer initiative fostering
collaboration between public and private health care payers to
strengthen primary care. Under this initiative, we will pay
participating primary care practices a care management fee to support
enhanced, coordinated services. Simultaneously, participating
commercial, state, and other federal insurance plans are also offering
enhanced support to primary care practices that provide high-quality
primary care. There are approximately 483 CPC practice sites across 7
health care markets in the U.S. More details on the CPC initiative can
be found at http://innovation.cms.gov/initiatives/Comprehensive-Primary-Care-Initiative/index.html.
Under the CPC initiative, CPC practice sites are required to report
to CMS a subset of the CQMs that were selected in the EHR Incentive
Program Stage 2 final rule for EPs to report under the EHR Incentive
Program beginning in CY 2014 (for a list of CQMs that were selected in
the EHR Incentive Program Stage 2 final rule for EPs to report under
the EHR Incentive Program beginning in CY 2014, see 77 FR 54069 through
54075). We propose to retain the group reporting option for CPC
practice sites as finalized in the CY 2014 PFS final rule, but to relax
the requirement for the CQMs to cover three domains. Instead, we
propose that, for CY 2015 only, under this group reporting option, the
CPC practice site must report a minimum of nine CQMs from the CPC
subset, and the nine CQMs reported must cover at least 2 domains,
although we strongly encourage practice sites to report across more
domains if feasible. Although the requirement to report across three
domains is important because the domains are linked to the National
Quality Strategy and used throughout CMS quality programs, the CPC
practice sites are required to report from a limited number of CQMs
that were selected for the EHR Incentive Program and are focused on a
primary care population. Therefore, these CPC practice sites may not
have measures to select from that cover three domains. Additionally,
CPC practice sites are assessed for quality performance on measures
other than electronically specified CQMs which do cover other National
Quality Strategy domains. We invite public comment on this proposal.
M. Medicare Shared Savings Program
Under section 1899 of the Act, CMS has established the Medicare
Shared Savings program (Shared Savings Program) to facilitate
coordination and cooperation among providers to improve the quality of
care for Medicare Fee-For-Service (FFS) beneficiaries and reduce the
rate of growth in health care costs. Eligible groups of providers and
suppliers, including physicians, hospitals, and other health care
providers, may participate in the Shared Savings Program by forming or
participating in an Accountable Care Organization (ACO). The final rule
implementing the Shared Savings Program appeared in the November 2,
2011 Federal Register (Medicare Shared Savings Program: Accountable
Care Organizations Final Rule (76 FR 67802)).
Section 1899(b)(3)(A) of the Act requires the Secretary to
determine appropriate measures to assess the quality of care furnished
by ACOs, such as measures of clinical processes and outcomes; patient,
and, wherever practicable, caregiver experience of care; and
utilization such as rates of hospital admission for ambulatory
sensitive conditions. Section 1899(b)(3)(B) of the Act requires ACOs to
submit data in a form and manner specified by the Secretary on measures
that the Secretary determines necessary for ACOs to report to evaluate
the quality of care furnished by ACOs. Section 1899(b)(3)(C) of the Act
requires the Secretary to establish quality performance standards to
assess the quality of care furnished by ACOs, and to seek to improve
the quality of care furnished by ACOs over time by specifying higher
standards, new measures, or both for the purposes of assessing the
quality of care. Additionally, section 1899(b)(3)(D) of the Act gives
the Secretary authority to incorporate reporting requirements and
incentive payments related to the PQRS, EHR Incentive Program and other
similar initiatives under section 1848 of the Act. Finally, section
1899(d)(1)(A) of the Act states that an ACO is eligible to receive
payment for shared savings, if they are generated, only after meeting
the quality performance standards established by the Secretary.
In the November 2011 final rule establishing the Shared Savings
Program, we established the quality performance standards that ACOs
must meet to be eligible to share in savings that are generated (76 FR
67870 through 67904). Quality performance measures are submitted by
ACOs through a CMS web interface, currently the group practice
reporting (GPRO) web interface, calculated by CMS from internal and
claims data, and collected through a patient and caregiver experience
of care survey.
Consistent with the directive under section 1899(b)(3)(C) of the
Act, we believe the existing Shared Savings Program regulations
incorporate a built in mechanism for encouraging ACOs to improve care
over the course of their 3-year agreement period, and to reward quality
improvement over time. During the first year of the agreement period,
ACOs can qualify for the maximum sharing rate by completely and
accurately reporting all quality measures. After that, ACOs must meet
certain thresholds of performance, which are currently phased in, and
are rewarded for improved performance on a sliding scale in which
higher levels of quality performance translate to higher rates of
shared savings (or, for ACOs subject to performance-based risk that
demonstrate losses, lower rates of shared losses). In this way, the
quality performance standard increases over the course of the ACO's
agreement period.
Additionally, we have made an effort to align quality performance
measures, submission methods, and incentives under the Shared Savings
Program with the PQRS. Eligible professionals participating in an ACO
may qualify for the PQRS incentive payment under the Shared Savings
Program or avoid the downward PQRS payment adjustment when the ACO
satisfactorily reports the
[[Page 40476]]
ACO GPRO measures on their behalf using the GPRO web interface.
Since the November 2011 final rule establishing the Shared Savings
Program was issued, we have revisited certain aspects of the quality
performance standard in the annual PFS rulemaking out of a desire to
ensure thoughtful alignment with the agency's other quality incentive
programs that are addressed in that rule. Specifically, we have updated
our rules to align with PQRS and the EHR Incentive Program, and
addressed issues related to benchmarking and scoring ACO quality
performance (77 FR 69301 through 69304; 78 FR 74757 through 74764). We
have identified several policies related to the quality performance
standard that we would like to address in this rule at this time.
Specifically, we are revisiting the current quality performance
standard, proposing changes to the quality measures, and seeking
comment on future quality performance measures. We are also proposing
to modify the timeframe between updates to the quality performance
benchmarks, to establish an additional incentive to reward ACO quality
improvement, and to make several technical corrections to the
regulations in subpart F of Part 425.
1. Existing Quality Measures and Performance Standard
As discussed previously, section1899(b)(3) of the Act states that
the Secretary may establish quality performance standards to assess the
quality of care furnished by ACOs and ``seek to improve the quality of
care furnished by ACOs over time by specifying higher standards, new
measures, or both. . . .'' In the November 2011 Shared Savings Program
final rule, we established a quality performance standard that consists
of 33 measures. These measures are submitted by the ACO through the
GPRO web interface, calculated by CMS from administrative and claims
data, and collected via a patient experience of care survey based on
the Clinician and Group Consumer Assessment of Healthcare Providers and
Systems (CG-CAHPS) survey. Although the patient experience of care
survey used for the Shared Savings Program includes the core CG-CAHPS
modules, this patient experience of care survey also includes some
additional modules. Therefore, we will refer to the patient experience
of care survey that is used under the Shared Savings Program as CAHPS
for ACOs. The measures span four domains, including patient experience
of care, care coordination/patient safety, preventive health, and at-
risk population. The measures collected through the GPRO web interface
are also used to determine whether eligible professionals participating
in an ACO qualify for the 2013 and 2014 PQRS incentive payment or avoid
the PQRS payment adjustment for 2015 and subsequent years. Eligible
professionals in an ACO may qualify for the PQRS incentive payment or
avoid the downward PQRS payment adjustment when the ACO satisfactorily
reports all of the ACO GPRO measures on their behalf using the GPRO web
interface.
In selecting the 33 measure set, we balanced a wide variety of
important considerations. Given that many ACOs were expected to be
newly formed organizations, in the November 2011 Shared Savings Program
final rule (76 FR 67886), we concluded that ACO quality measures should
focus on discrete processes and short-term measurable outcomes derived
from administrative claims and limited medical record review
facilitated by a CMS-provided web interface to lessen the burden of
reporting. Because of the focus on Medicare FFS beneficiaries, our
measure selection emphasized prevention and management of chronic
diseases that have high impact on these beneficiaries such as heart
disease, diabetes mellitus, and chronic obstructive pulmonary disease.
We believed that the quality measures used in the Shared Savings
Program should be tested, evidence-based, target conditions of high
cost and high prevalence in the Medicare FFS population, reflect
priorities of the National Quality Strategy, address the continuum of
care to reflect the requirement that ACOs accept accountability for
their patient populations, and align with existing quality programs and
value-based purchasing initiatives.
At this time, we continue to believe it is most appropriate to
focus on quality measures that directly assess the overall quality of
care furnished to FFS beneficiaries. The set of 33 measures that we
adopted in the November 2011 Shared Savings Program final rule includes
measures addressing patient experience, outcomes, and evidence-based
care processes. Thus far, we have not included any specific measures
addressing high cost services or utilization since we believe that the
potential to earn shared savings offers an important and direct
incentive for ACOs to address utilization issues in a way that is most
appropriate for their organization, patient population, and local
healthcare environment. We note that while the quality performance
standard is limited to these 33 measures, the performance of ACOs is
measured on many more metrics and ACOs are informed of their
performance in these areas. For example, an assessment of an ACO's
utilization of certain resources is provided to the ACO via quarterly
reports that contain information such as the utilization of emergency
services or the utilization of CTs and MRIs.
As we have stated previously (76 FR 67872), our principal goal in
selecting quality measures for ACOs was to identify measures of success
in the delivery of high-quality health care at the individual and
population levels. We believe endorsed measures have been tested,
validated, and clinically accepted, and therefore, selected the 33
measures with a preference for NQF-endorsed measures. However, the
statute does not limit us to using endorsed measures in the Shared
Savings Program. As a result we also exercised our discretion to
include certain measures that we believe to be high impact but that are
not currently endorsed, for example, ACO11, Percent of PCPs
Who Successfully Qualify for an EHR Incentive Program Payment.
In selecting the final set of 33 measures, we sought to include
both process and outcome measures, including patient experience of care
(76 FR 67873). Because ACOs are charged with improving and coordinating
care and delivering high quality care, but also need time to form,
acquire infrastructure and develop clinical care processes, we continue
to believe it is important to have a combination of both process and
outcomes measures. We note, however, that as other CMS quality
reporting programs, such as PQRS, move to more outcomes-based measures
and fewer process measures over time, we may also revise the quality
performance standard for the Shared Savings Program to incorporate more
outcomes-based measures over time.
Therefore, we viewed the 33 measures adopted in the November 2011
Shared Savings Program final rule as a starting point for ACO quality
measurement. As we stated in that rule (67 FR 67891), we plan to modify
the measures in future reporting cycles to reflect changes in practice
and improvements in quality of care and to continue aligning with other
quality reporting programs and will add and/or retire measures as
appropriate through the rulemaking process. In addition, we are working
with the measures community to ensure that the specifications for the
measures used under the Shared Savings Program are up-to-date. We note
that we must balance the timing of the release of specifications so
they are as up-to-date
[[Page 40477]]
as possible, while also giving ACOs sufficient time to review
specifications. Our intention is to issue the specifications annually,
prior to the start of the reporting period for which they will apply.
For example, we issued the specifications for the 2014 reporting period
in late 2013, prior to the start of the 2014 reporting period.
In the November 2011 Shared Savings Program final rule (76 FR
67873), we combined care coordination and patient safety into a single
domain to better align with the National Quality Strategy and to
emphasize the importance of ambulatory patient safety and care
coordination. We also intended to continue exploring ways to best
capture ACO care coordination metrics and noted that we would consider
adding new care coordination measures for future years (67 FR 67877).
2. Proposed Changes to the Quality Measures Used in Establishing
Quality Performance Standards That ACOs Must Meet To Be Eligible for
Shared Savings
Since the November 2011 Shared Savings Program final rule, we have
continued to review the quality measures used for the Shared Savings
Program to ensure that they are up to date with current clinical
practice and are aligned with the GPRO web interface reporting for
PQRS. Based on the reviews, we have identified a number of proposed
measure additions, deletions and other revisions that we believe would
be appropriate for the Shared Savings Program. Under the following
proposed measure revisions, ACOs would be assessed on 37 measures
annually, an increase of 4 measures. However, as explained in more
detail below, we believe the measures chosen are more outcome-oriented
and would ultimately reduce the reporting burden on ACOs.
The following is a description of the proposed changes that would
be effective for the 2015 reporting period and would be reported by
ACOs to us in early 2016. Table 50 offers an overview of the proposed
changes and is provided as a reference. (We note that the deletion and
insertion of certain measures affects the composite measures, and we
are proposing corresponding revisions to both the diabetes and coronary
artery disease composite measures.)
CAHPS Stewardship of Patient Resources. This measure is
one of the unscored survey measures currently collected in addition to
the seven that are already part of the current set of 33 scored
measures under the Shared Savings Program. Information on the unscored
survey measure modules is currently shared with the ACOs for
informational purposes only. The Stewardship of Patient Resources
measure asks the patient whether the care team talked with the patient
about prescription medicine costs. The measure exhibited high
reliability during the first two administrations of the CAHPS survey,
and during testing, the beneficiaries that participated in cognitive
testing said that prescription drug costs was important to them. We are
proposing to add Stewardship of Patient Resources as a scored measure
in the patient experience domain because we believe, based on testing,
that this is an important factor for measuring a beneficiary's
experience with healthcare providers. We are also proposing that the
measure would be phased into pay for performance as we plan to do for
other new measures, using a similar process to the phase in that was
used for the measure modules in the survey that are currently used to
assess ACO quality performance. We seek comment on this proposal and on
any other patient experience of care measures that might be considered
in future rulemaking.
Skilled Nursing Facility 30-Day All-Cause Readmission
Measure (SNFRM). We propose to add a 30-day all cause SNF readmission
measure. CMS is the measure steward for this claims based measure which
is under review at NQF under NQF 2510. This measure estimates
the risk-standardized rate of all-cause, unplanned, hospital
readmissions for patients who have been admitted to a Skilled Nursing
Facility within 30 days of discharge from a prior inpatient admission
to a hospital, CAH, or a psychiatric hospital. The measure is based on
data for 12 months of SNF admissions. We believe this measure would
help fill a gap in the current Shared Savings Program measure set and
would provide a focus on an area where ACOs are targeting care
redesign. ACOs and their ACO providers/suppliers often include post-
acute care (PAC) settings and the addition of this measure would
enhance the participation and alignment with these facilities. Even
when the ACO does not include post-acute facilities formally as part of
its organization, ACO providers/suppliers furnish other services that
have the potential to affect PAC outcomes. Thus, this measure would
emphasize the importance of coordinating the care of beneficiaries
across these sites of care. Additionally, because this measure is
calculated from claims, there would not be a burden on ACOs to collect
this information.
All-Cause Unplanned Admissions for Patients with Diabetes
Mellitus (DM), Heart Failure (HF) and Multiple Chronic Conditions. We
propose to add three new measures to the Care Coordination/Patient
Safety domain. The three proposed new measures are for: all-cause
unplanned Admissions for Patients with Diabetes Mellitus (DM), all-
cause unplanned Admissions for Patients with Heart Failure (HF) and
all-cause unplanned Admissions for Patients with Multiple Chronic
Conditions. These three measures are under development though a CMS
contract with Yale New Haven Health Services Corporation/Center for
Outcomes Research and Evaluation (CORE) to develop quality measures
specifically for ACO patients with heart failure, diabetes, and
multiple chronic conditions. We believe that these measures are
important to promote and assess ACO quality as it relates to chronic
condition inpatient admission because they are major causes for
unplanned admissions and will support the ACOs' efforts to improve care
coordination for these chronic conditions. These measures are claims
based, and therefore, we do not expect that they would impose any
additional burden on ACOs.